US20170273680A1 - Tissue augmentation tacks for use with soft tissue fixation repair systems and methods - Google Patents

Abstract

Devices, systems, and methods to improve both the reliability of soft tissue repair procedures and the speed at which the procedures are completed are provided. The devices and systems include one or more tissue augmentation constructs, which include constructs that are configured to increase a footprint across which suture applied force to tissue when the suture is tied down onto the tissue. The tissue augmentation constructs can be quickly and easily associated with the repair suture, and can be useful in many different tissue repair procedures that are disclosed in the application. In one exemplary embodiment, one or more constructs are disposed on a suture threader, which can be used to associate the construct(s) with a repair suture(s) being used to repair the soft tissue. Tissue augmentation constructs can include various blocks and patches, among other formations. Exemplary methods for manufacturing the tissue augmentation constructs are also provided.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation-in-part of and claims priority to U.S. patent application Ser. No. 15/419,330, filed Jan. 30, 2017, and entitled “TISSUE AUGMENTATION CONSTRUCTS FOR USE WITH SOFT TISSUE FIXATION REPAIR SYSTEMS AND METHODS,” which claims priority to each of U.S. Provisional Patent Application Ser. No. 62/289,702, filed Feb. 1, 2016, and entitled “COMPRESSION STRIPS AND SCAFFOLDS FOR USE IN SOFT TISSUE FIXATION,” U.S. Provisional Patent Application Ser. No. 62/348,548, filed Jun. 10, 2016, and entitled “COMPRESSION CONSTRUCTS AND RELATED METHODS FOR USE IN SOFT TISSUE FIXATION,” and U.S. Provisional Patent Application Ser. No. 62/393,277, filed Sep. 12, 2016, and entitled “TISSUE AUGMENTATION CONSTRUCTS AND RELATED METHODS FOR USE IN SOFT TISSUE FIXATION,” all of which are incorporated by reference herein in their entireties.
FIELD
• The present disclosure relates to systems, devices, and methods for securing soft tissue to bone, and more particularly relates to systems, devices, and methods that increase the area of coverage and/or compression between suture filament and tissue during procedures like rotator cuff repairs.
BACKGROUND
• A common injury, especially among athletes and people of advancing age, is the complete or partial detachment of tendons, ligaments, or other soft tissues from bone. Tissue detachment may occur during a fall, by overexertion, or for a variety of other reasons. Surgical intervention is often needed, particularly when tissue is completely detached from its associated bone. Currently available devices for tissue attachment include screws, staples, suture anchors, and tacks. Currently available devices for patients of advancing age can be particularly insufficient due to degenerated tissue leading to inadequate suture-to-anchor fixation and further damage to the soft tissue.
• Repair constructs made from one or more surgical filaments are typically used in soft tissue repair procedures, e.g., rotator cuff fixations, to secure the tissue in a desired location. The repair constructs are typically disposed through one or more portions of the tissue to be repaired, which can cause trauma to the tissue, and are often coupled to anchors disposed in bone to which the tissue is to be approximated. Further, in situations where the soft tissue has already begun to degenerate, the added pressure applied by the sutures can cause further damage to the tissue, for instance by causing abrasion of the tissue or “cheese-wiring,” which refers to one or more strings of tissue peeling away from the main tissue like a string of cheese peels away from a cheese block when a wire cheese slicer is used to separate cheese from the block. In other words, because the suture has a small surface area, and a significant amount of force is being applied to the soft tissue over the small surface area of the tissue, the suture may have a tendency to cut into the already compromised tissue, thus causing further damage. Currently available solutions to this problem include the application of a relatively large formation of allograft or xenograft, typically about 3 centimeters by about 3 centimeters, to the soft tissue after the repair has been performed but prior to tightening the soft tissue down with the suture. The application of the formation, however, is often expensive, necessitates many sutures, and requires a high skill level to operate and is thus used by only a select few surgeons. Further, the application of the relatively large formation can add a significant amount of time to a surgical procedure, on the order of an additional half hour to one hour per allograft or xenograft formation applied.
• It is therefore desirable to provide systems, devices, and methods for use in soft tissue repair that are robust, strong, and promote healing, yet minimize the costs and time of the procedure.
SUMMARY
• Systems, devices, and methods are generally provided for performing surgical procedures involving sutures, such as rotator cuff repairs, among other suture repair procedures. More specifically, the systems, devices, and methods are designed to allow a user to quickly add one or more tissue augmentation constructs or matrices onto suture being used to perform the tissue repair. The tissue augmentation constructs, which come in a variety of configurations, including but not limited to tapes, tubes, blocks, rings, tacks, washers, and patches, can expand a footprint of the sutures with which they are associated. The expanded footprint helps distribute force applied by the suture on the tissue across a greater surface area, can protect aspects of the system and/or tissue, provide bulk to otherwise compromised or degenerate tissue and/or tendon, and can help promote tissue growth and repair at the surgical site.
• The tissue augmentation constructs can be associated with the suture(s) in an on-demand fashion so that a surgeon can quickly and easily expand the footprint of the sutures, or similarly purposed materials such as suture tape, being used based on the needs presented during the procedure. The constructs can be associated with suture using a variety of techniques, including disposing the constructs on the suture and threading the suture through the constructs, among other techniques. In some exemplary embodiments, a tissue augmentation construct is predisposed on a threader, and the threader is operable to associate a suture being used in the soft tissue repair with the tissue augmentation construct. Surgical procedures that utilize the tissue augmentation constructs provided for in the present disclosure are also provided, as are various manufacturing techniques and methods for forming tissue augmentation constructs.
• In one exemplary embodiment, a surgical soft tissue repair system includes a first suture limb and a first tissue augmentation block. The tissue augmentation block is disposed on the first suture limb such that the first tissue augmentation block extends along a first length of the first suture limb. As a result, a tissue engaging surface area of the system along the first length is increased. The system can additionally include a second suture limb and a second tissue augmentation block. The second tissue augmentation block can be disposed on the second suture limb such that the second tissue augmentation block extends along a second length of the second suture limb. The second tissue augmentation block can further increase a second tissue engaging surface area of the system along the second length. The first suture limb and the second suture limb can be formed from a single suture. Alternatively, the first suture limb and the second suture limb can be formed from different sutures.
• The first tissue augmentation block can have a number of different configurations. In one configuration, the first tissue augmentation block includes an opening that extends through the first tissue augmentation block with the first suture limb being disposed through the opening of the first tissue augmentation block such that the first tissue augmentation block freely passes along a length of the first suture limb in an unrestricted manner. In a second configuration, the first tissue augmentation block includes a tape having a substantially flat tissue-engaging surface with a width that is at least two times as large as a diameter of the first suture limb and a length that is substantially greater than the width of the tape. The first suture limb on which the tape is disposed extends through the substantially flat tissue-engaging surface of the tape at a plurality of locations along the length of the substantially flat tissue-engaging surface. Other configurations of tissue augmentation blocks are also provided for, including but not limited to bars and washers. In configurations where the system includes first and second tissue augmentation blocks, the first and second tissue augmentation blocks can have the same or different configurations. Further, in some embodiments, the first tissue augmentation block can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, the first tissue augmentation block includes collagen. The blocks can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skill in the art or otherwise provided for herein.
• In some embodiments, at least one additional tissue augmentation block can be disposed on the first suture limb. For example, each of an additional tissue augmentation block of the at least one additional tissue augmentation block and the first tissue augmentation block disposed on the first suture limb can include a washer. The washer can have an opening that extends through a thickness of the washer, and the first suture limb on which the washer is disposed can extend through the washer opening. The washer can be sized such that the thickness of the washer is substantially less than a length of the first suture limb on which the washer is disposed.
• The system can also include a threader on which the first tissue augmentation block is disposed. The threader can include a distal end that is configured to receive the first suture limb and dispose the first tissue augmentation block onto the first suture limb as the threader is moved with respect to the first tissue augmentation block. The threader can more specifically include a collapsible opening at the distal end that is configured to receive the first suture limb, a proximal handle portion, and an elongate intermediate portion that extends between the collapsible opening and the proximal handle portion. The elongate intermediate portion can have the first tissue augmentation block disposed on it. The threader can be configured such that applying a force to the proximal handle portion advances the elongate intermediate portion and the collapsible opening in the direction of the applied force such that when the first suture limb is disposed within the collapsible opening, the applied force disposes the first tissue augmentation block onto the first suture limb. The system can further include an installation tool that has a handle portion and a cartridge. The cartridge can have a length and a width that is sized to receive and retain the first tissue augmentation block disposed on the threader, with the threader extending through the entire length of the cartridge.
• In another exemplary embodiment, a soft tissue suture repair system includes a tissue augmentation block and a threader. The threader has a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end. The intermediate portion of the threader has the tissue augmentation block disposed on it. Further, the threader is configured to dispose the tissue augmentation block onto a suture by associating a suture with the distal receiving end and applying a force to the proximal handle to advance the distal receiving end towards the tissue augmentation block.
• In some embodiments the threader can be configured such that the distal receiving end, and thus a suture associated therewith, passes through the tissue augmentation block in response to the application of the force to the proximal handle. Sometimes, the intermediate portion is a filament portion, a fiber, a thread, a wire, a cord, and/or some other flexible structure. Further, the system can include a suture that can be configured to be associated with the distal receiving end of the threader and can be configured to have the tissue augmentation block disposed on it.
• The tissue augmentation block can have various configurations. In one configuration, the tissue augmentation block includes an opening that extends through the block and the intermediate portion of the threader can be disposed through the opening. In a second configuration, the tissue augmentation block includes a tape having a substantially flat tissue-engaging surface with a width that is at least two times as large as a diameter of the suture on which the tape is disposed, and a length that is substantially greater than the width of the tape. The intermediate portion of the threader on which the tape is disposed can extend through the substantially flat tissue-engaging surface of the tape at a plurality of locations along the length of the substantially flat tissue-engaging surface. Other configurations are also provided for, including but not limited to the tissue augmentation block including a bar or a washer.
• The system can include an installation tool for disposing the tissue augmentation block on a suture. The installation tool can include a handle portion and a cartridge. The cartridge can have a length and a width that is sized to receive and retain the tissue augmentation block. Further, in some embodiments, the tissue augmentation block can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, and fascia, and in some embodiments, the tissue augmentation block include collagen.
• In still another exemplary embodiment, a surgical kit for soft tissue repair includes one or more bone anchors, one or more sutures, one or more tissue augmentation blocks, and one or more threaders. Each tissue augmentation block is configured to be disposed on a suture limb of a suture of the one or more sutures. Further, at least one of the threaders is configured to dispose a tissue augmentation block of the one or more tissue augmentation blocks onto a suture of the one or more sutures.
• In some embodiments the surgical kit can also include a drill for drilling a bone hole sized to receive a bone anchor of the one or more bone anchors. In various embodiments, the one or more tissue augmentation blocks can include a plurality of tissue augmentation blocks, and/or the one or more sutures can include a plurality of sutures, and/or the one or more bone anchors can include a plurality of bone anchors.
• One of the one or more tissue augmentation blocks can include an opening extending through the block. The opening can be configured to have the suture limb extending through the tissue augmentation block when the tissue augmentation block is disposed on the suture limb such that the tissue augmentation block freely passes along a length of the suture limb in an unrestricted manner. Alternatively, one of the one or more tissue augmentation blocks can include a tape having a substantially flat tissue-engaging surface with a width that is at least two times as large as a diameter of the suture limb on which the tissue augmentation block is disposed and a length that is substantially greater than the width of the tape. The substantially flat tissue-engaging surface can be configured to have the suture limb extend through it at a plurality of locations along the length of the substantially flat tissue-engaging surface when the tissue augmentation block is disposed on the suture limb. Other configurations of the one or more tissue augmentation blocks are also provided for, including but not limited to bars and washers. The washers can be sized such that a thickness of the washer is substantially less than a length of a suture limb on which the washer is to be disposed. Further, in some embodiments, a tissue augmentation block of the one or more tissue augmentation blocks can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, one or both of the first and second augmentation blocks includes collagen. The blocks can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skill in the art or otherwise provided for herein.
• One or more of the threaders can include a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end. The threader can be configured to dispose one or more tissue augmentation blocks onto one or more sutures by associating one or more sutures with the distal receiving end and applying a force to the proximal handle to advance the distal receiving end towards the one or more tissue augmentation blocks. The distal receiving end can be configured such that the distal receiving end, and thus one or more sutures associated therewith, passes through one or more tissue augmentation blocks in response to the application of the force to the proximal handle.
• In an exemplary method of soft tissue repair, the method includes attaching a first suture to soft tissue such that two suture limbs of the first suture extend from the soft tissue, disposing at least one tissue augmentation block on at least one of the first and second suture limbs, coupling the two suture limbs with at least one suture anchor disposed in bone, and tightening the suture limbs such that the tissue augmentation block(s) is directed towards the soft tissue. By disposing a tissue augmentation block on at least one of the two suture limbs, a surface area for engaging tissue associated with the respective suture limb is increased. One or more tissue augmentation blocks can be disposed on both suture limbs if desired.
• In some embodiments the step of attaching a first suture to soft tissue such that two suture limbs of the suture extend from the soft tissue further comprises installing a medial row stitch. In such embodiments, the step of coupling the two suture limbs with at least one suture anchor disposed in bone can include installing a lateral row fixation.
• In some embodiments the step of disposing at least one tissue augmentation block on at least one of the first and second limbs can include coupling a first limb of the two suture limbs to a threader associated with a first tissue augmentation block and applying a force to the threader associated with the first tissue augmentation block to dispose the first tissue augmentation block on the first limb. The method can further include coupling a second limb of the two suture limbs to a threader associated with a second tissue augmentation block and applying a force to the threader associated with the second tissue augmentation block on the second limb.
• The tissue augmentation block(s) used in the methods can have a variety of configurations. For example, in some instances, one or more of the tissue augmentation blocks can include an opening extending through the block, and the opening can be configured to have one of the suture limbs extending therethrough when the tissue augmentation block is disposed on the respective suture limb such that the tissue augmentation block freely passes along a length of the suture limb in an unrestricted manner. By way of further non-limiting example, in some instances, one or more of the tissue augmentation blocks can include a tape having a substantially flat tissue-engaging surface with a width that is at least two times greater than a diameter of the suture limb on which the block is disposed, and a length that is substantially greater than the width of the tape. The substantially flat tissue-engaging surface can be configured to have the suture limb extend through it at a plurality of locations along the length of the substantially flat tissue-engaging surface when the tissue augmentation block is disposed on the suture limb. Other configurations of tissue augmentation blocks are also provided for, including but not limited to bars and washers. The washers can be sized such that a thickness of the washer is substantially less than a length of a suture limb on which the washer is to be disposed. Further, in some embodiments, one or more of the tissue augmentation blocks can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, one or both of the first and second augmentation blocks includes collagen. The blocks can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skill in the art or otherwise provided for herein.
• In some embodiments that include a second suture, the step of coupling the two suture limbs with at least one suture anchor disposed in bone can include coupling the two suture limbs with a first suture anchor of the at least one suture anchor. The method can additionally include attaching a second suture to the soft tissue such that a third suture limb and a fourth suture limb extend from the soft tissue. At least one second tissue augmentation block can be can be disposed on at least one of the third and fourth suture limbs, and the third and fourth suture limbs can be coupled with a second anchor of the at least one suture anchor disposed in bone. The method can further include tightening the third and fourth suture limbs such that the second tissue augmentation block is directed towards the soft tissue. By disposing a tissue augmentation block on at least one of the third and fourth suture limbs, a surface area for engaging tissue associated with at least one of the third and fourth suture limbs is increased. One or more tissue augmentation blocks can be disposed on both suture limbs if desired.
• The step of disposing at least one tissue augmentation block on at least one of the first and second suture limbs can include disposing a first tissue augmentation block on the first suture limb and a second tissue augmentation block on the second suture limb in some instances. In some of those instances, the first and second suture limbs can be coupled together to form a mattress stitch.
• In yet other embodiments the method can further include attaching a second suture to the soft tissue such that a third suture limb and a fourth suture limb extend from the soft tissue, disposing at least one second tissue augmentation block on at least one of the third and fourth suture limbs, and disposing at least one tissue augmentation block on each of the first and second suture limbs of the first suture. By disposing tissue augmentation blocks on the first, second, and at least one of the third and fourth suture limbs, a surface area for engaging tissue associated with the respective suture limbs are increased. The method can further include coupling the first and third suture limbs with a first suture anchor disposed in the bone, and coupling the second and fourth suture limbs with a second suture anchor disposed in the bone. In some embodiments, the second and third limbs can cross over each other. The method can further include tightening the first, second, third, and fourth suture limbs such that the tissue augmentation blocks are directed towards the soft tissue.
• In still other embodiments, the method can further include attaching a second suture to the soft tissue such that a third suture limb and a fourth suture limb extend from the soft tissue. The first and second limbs of the first suture can be coupled together, for instance by using a first knot to tie them together. The at least one tissue augmentation block that is disposed on at least one of the first and second suture limbs can be slid over the first knot. The third and fourth suture limbs also can be coupled together, for instance by using a second knot to tie them together. At least one of the third and fourth suture limbs can extend above the at least one tissue augmentation block to help maintain a location of the at least one tissue augmentation block with respect to the soft tissue.
• Sometimes the method can include attaching a second suture to the soft tissue at a location that is laterally displaced from a location of the first suture such that a third suture limb and a fourth suture limb extend from the soft tissue. Further, a tissue augmentation block of the at least one tissue augmentation block can be disposed on the first suture limb. The first and third suture limbs can be coupled together to form a mattress stitch, for instance by using a first knot to tie them together, and the tissue augmentation block of the at least one tissue augmentation block can be slid over the first knot. The second and fourth suture limbs also can be coupled together, for instance by using a second knot to tie them together. At least one of the second and fourth suture limbs can extend above the tissue augmentation block to help maintain a location of the tissue augmentation block with respect to the soft tissue.
• In other embodiments, the first tissue augmentation block of the at least one tissue augmentation block can be disposed on the first suture limb. In some such embodiments, the method can include attaching a second suture to the soft tissue such that a third suture limb and a fourth suture limb extend from the soft tissue. A second tissue augmentation block of the at least one tissue augmentation block can be disposed on the fourth suture limb, thereby increasing a surface area for engaging tissue associated with the fourth suture limb. Further, a third tissue augmentation block of the at least one tissue augmentation block can be disposed on each of the second and third suture limbs. The first and second suture limbs can be coupled with a first suture anchor disposed in the bone, and the third and fourth suture limbs can be coupled with a second suture anchor disposed in the bone. The first, second, third, and fourth suture limbs can be tightened such that the first, second, and third tissue augmentation blocks can be directed towards the soft tissue.
• Another exemplary method of soft tissue repair includes coupling a first suture limb of a first suture to a first threader having a first tissue augmentation block disposed thereon, the first suture being attached to a first suture implant disposed in bone in a body, and the first suture limb being coupled to tissue, and applying a force to the first threader to move the first threader with respect to the first tissue augmentation block such that the first suture limb is passed into the first tissue augmentation block to dispose the first tissue augmentation block onto a portion of the first suture limb. The first suture limb and the first tissue augmentation block are then disassociated from the first threader, and the first tissue augmentation block is advanced towards the first suture implant. A portion of the first suture limb is secured at a surgical site, and a location of the first tissue augmentation block and/or the first suture limb is adjusted with respect to the tissue.
• In some embodiments, the first suture can be coupled to the tissue by forming a medial row stitch with the first suture. Further, in some instances the method can include coupling a second suture limb of the first suture to a second threader having a second tissue augmentation block disposed thereon, the second suture limb being coupled to tissue, and applying a force to the second threader to move the second threader with respect to the second tissue augmentation block such that the second suture limb is passed into the second tissue augmentation block to dispose the second tissue augmentation block onto a portion of the second limb. The second suture limb and the second tissue augmentation block can be disassociated from the second threader. The second tissue augmentation block can be advanced towards the first suture implant, and a portion of the second suture limb can be secured at the surgical site. In some embodiments in which the first suture includes both a first suture limb and second suture limb, the first and second suture limbs can be coupled together by way of a mattress stitch.
• Various methods provided for can also include a second suture associated with a second suture implant. More specifically, a third suture limb of a second suture can be coupled to a third threader having a third tissue augmentation block disposed on it. The second suture can be attached to a second suture implant disposed in bone in a body, and the third suture limb can be coupled to tissue. A force can be applied to the third threader to move the threader with respect to the third tissue augmentation block. As a result, the third suture limb can be passed into the third tissue augmentation block to dispose the third tissue augmentation block onto a portion of the third suture limb. The third suture limb and the third tissue augmentation block can be disassociated from the third threader, and a portion of the third suture limb can be secured at the surgical site. A portion of the first suture limb of the first suture can be secured at the surgical site by coupling the first suture limb to a first lateral anchor, a portion of the second suture limb of the first suture can be secured at the surgical site by coupling the second suture limb to a second lateral anchor, and a portion of the third suture limb of the second suture can be secured at the surgical site by coupling the third suture limb to the second lateral anchor. Further, a portion of a fourth suture limb of the second suture can be secured at the surgical site by coupling the fourth suture limb to the first lateral anchor.
• In some embodiments, the step of securing a portion of the first suture limb at the surgical site can include coupling a second suture limb of the first suture with the first suture limb using a first knot. Further, the step of adjusting a location of at least one of the first tissue augmentation block and first suture limb with respect to the tissue can include sliding the first tissue augmentation block over the first knot. In such embodiments, the method can also include coupling a third suture limb and a fourth suture limb of a second suture that extend from the tissue with a second knot. Further, at least one of the third and fourth suture limbs can extend above the first tissue augmentation block to help maintain a location of the first tissue augmentation block with respect to the tissue.
• In some other embodiments, the step of securing a portion of the first suture limb at the surgical site can include coupling a third suture limb of a second suture that extends from the tissue with a first knot to form a mattress stitch. Further, the step of adjusting a location of at least one of the first tissue augmentation block and first suture limb with respect to the tissue can include sliding the first tissue augmentation block over the first knot. In such embodiments, the method can also include coupling the second suture limb of the first suture and a fourth suture limb of the second suture with a second knot. Further, at least one of the second and fourth suture limbs can extend above the first tissue augmentation block to help maintain a location of the first tissue augmentation block with respect to the tissue. Still further, a location of the second suture can be laterally displaced with respect to a location of the first suture.
• In still some other embodiments, the method can include coupling a fourth suture limb of a second suture to a third threader having a third tissue augmentation block disposed on it. The fourth suture limb can be coupled to tissue. A force can be applied to the second threader to move the second threader with respect to the second tissue augmentation block so that the fourth suture limb is passed into the third tissue augmentation block. As a result, the third tissue augmentation block is disposed onto a portion of the fourth suture limb. The fourth suture limb and the third tissue augmentation block can be disassociated from the third threader. A portion of a third suture limb, which is also from the second suture, can be secured within the body by coupling the portion to a first suture anchor that is disposed in bone. A portion of the fourth suture limb can also be secured within the body by coupling it to the first suture anchor. The second tissue augmentation block can be disposed on the third suture limb, in addition to being disposed on the second suture limb. Further, securing portions of the first and second suture limbs at the surgical site can include coupling a portion of the respective first and second suture limbs to a second suture anchor disposed in bone.
• The first tissue augmentation block, or any tissue augmentation block for that matter, can have a variety of configurations. For example, in some instances the first tissue augmentation block can have an opening extending through the block, and the opening can be configured to have one of the suture limbs extending therethrough when the first tissue augmentation block is disposed on the respective suture limb such that the first tissue augmentation block freely passes along a length of the suture limb in an unrestricted manner. By way of further non-limiting example, in some instances the first tissue augmentation block can include a tape having a substantially flat tissue-engaging surface with a width that is at least two times greater than a diameter of the suture limb on which the block is disposed, and a length that is substantially greater than the width of the tape. The substantially flat tissue-engaging surface can be configured to have the suture limb extend through it at a plurality of locations along the length of the substantially flat tissue-engaging surface when the tissue augmentation block is disposed on the suture limb. Other configurations of tissue augmentation blocks are also provided for, including but not limited to bars and washers. The washers can be sized such that a thickness of the washer is substantially less than a length of a suture limb on which the washer is to be disposed. Further, in some embodiments, the first tissue augmentation block, or again any tissue augmentation block for that matter, can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, one or both of the first and second augmentation blocks includes collagen. The blocks can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skill in the art or otherwise provided for herein.
• In one exemplary embodiment of a soft tissue repair system that includes a patch or scaffold, the system has a scaffold, a first threader, and a second threader. Each of the first and second threaders include a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end, and the intermediate portion of each threader has the scaffold disposed on it. The first and second threaders are configured to dispose the scaffold onto sutures by associating respective sutures with the respective distal receiving ends and applying a force to the respective proximal handles to advance the respective distal receiving ends towards the scaffold.
• The first and second threaders can be configured so that their respective distal receiving ends, and thus suture(s) associated therewith, pass through the scaffold in response to the application of the force to the proximal handles. In some embodiments, the intermediate portion of each of the first and second threaders can include a filament portion, a fiber, a thread, a wire, a cord, and/or some other flexible structure. The proximal handles of the first and second suture threaders can be disposed on a first side of the scaffold, the distal receiving ends of the first and second threaders can be disposed on a second side of the scaffold, and the intermediate portions of the first and second threaders can extend from the first side to the second side in a pre-installation configuration.
• In some embodiments, the intermediate portion of the first threader can be disposed more proximate to a first side of the scaffold than a second, opposite side of the scaffold, and the intermediate portion of the second threader can be disposed more proximate to the second, opposite side of the scaffold than the first side. Further, a third threader and a fourth threader can also be provided, with each including a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end. The intermediate portion of each of the third and fourth threaders can have the scaffold disposed on it. Further, the third and fourth threaders can be configured to dispose the scaffold onto sutures by associating respective sutures with the respective distal receiving ends and applying a force to the respective proximal handles to advance the respective distal receiving ends towards the scaffold. In some embodiments, the intermediate portion of the third threader can be disposed diagonally with respect to the scaffold such that the distal receiving end of the third threader is proximate to the distal receiving end of the first threader and the proximal handle of the third threader is proximate to the proximal handle of the second threader, and the intermediate portion of the fourth threader can be disposed diagonally with respect to the scaffold such that the distal receiving end of the fourth threader is proximate to the distal receiving end of the second threader and the proximal handle of the fourth threader is proximate to the proximal handle of the first threader.
• The system can also include multiple sutures. For example, a first suture can be configured to be associated with the distal receiving end of the first threader and configured to have the scaffold disposed on it, and a second suture can similarly be configured to be associated with the distal receiving end of the second threader and configured to have the scaffold disposed on it. In some embodiments, the suture(s) can be coupled to the scaffold in a pre-installation configuration. By way of example, a first suture can be coupled to the scaffold at a first medial location on the scaffold and a second suture can be coupled to the scaffold at a second medial location on the scaffold. Each of the first and second sutures can include a hollow self-locking mechanism, and the intermediate portion of the first and second threaders can be disposed in the hollow self-locking mechanisms of the first and second sutures, respectively. Such a scaffold can include a flexible zone that is located at the first and second medial locations, with the flexible zone being configured to allow the scaffold to stretch.
• In embodiments having the first and second sutures coupled to the first and second medial locations as described, a leading tail can extend from each of the hollow self-locking mechanisms of the first and second sutures, towards a first side of the scaffold. The leading tails can be configured to be coupled to the distal receiving ends of the first and second threaders disposed within the respective hollow self-locking mechanisms of the first and second sutures. In some embodiments, a trailing tail can extend from each of the hollow self-locking mechanisms of the first and second sutures, towards a second, opposite side of the scaffold. Each of the trailing tails can be configured to be coupled to a suture anchor, whether the same anchor or different anchors. In some other embodiments, the system can include trailing tails that are separate sutures than the first and second sutures. For example, a first trailing tail can be disposed more proximate to a second, opposite side of the scaffold than the first side of the scaffold, and can also be disposed more proximate to the hollow self-locking mechanism of the first suture than the hollow self-locking mechanism of the second suture. Similarly, a second trailing tail can be disposed more proximate to the second, opposite end of the scaffold than the first side of the scaffold, and can also be disposed more proximate to the hollow self-locking mechanism of the second suture than the hollow self-locking mechanism of the first suture. Each of the trailing tails can be configured to be coupled to a suture anchor, whether the same anchor or different anchors.
• In some embodiments having the first and second sutures coupled to the first and second medial locations as described, third and fourth threaders and third and fourth sutures can also be provided. The third and fourth threaders can each include a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end. The intermediate portion of each of the third and fourth threaders can have the scaffold disposed on it, with the intermediate portion being associated with the third and fourth sutures. More specifically, the third and fourth sutures can be coupled to the scaffold proximate to the first and second medial locations, respectively. Each of the third and fourth sutures can include a hollow self-locking mechanism, and the intermediate portions of the third and fourth threaders can be disposed in the hollow self-locking mechanisms of the third and fourth sutures, respectively. Further, the third and fourth threaders can be configured to dispose the scaffold onto sutures by associating respective sutures with the respective distal receiving ends and applying a force to the respective proximal handles to advance the respective distal receiving ends towards the scaffold. In some embodiments, a leading tail can extend from each of the hollow self-locking mechanisms of the first, second, third, and fourth sutures. The leading tails of the first and second sutures can extend towards a first side of the scaffold, and the leading tails of the third and fourth sutures can extend towards a second, opposite side of the scaffold. The leading tails can be configured to be coupled to the distal receiving ends of the first, second, third, and fourth threaders disposed within the respective hollow self-locking mechanisms of the first, second, third, and fourth sutures.
• In some embodiments that include a scaffold and first and second threaders, one or more additional threaders can be provided. For example, a third threader and a fourth threader can be provided. Each of the third and fourth threaders can include a proximal handle, a distal receiving end, and an intermediate portion extending between the proximal handle and the distal receiving end. The intermediate portion of each of the third and fourth threaders can have the scaffold disposed on it, with the third threader being configured to dispose the scaffold onto the same suture as the first threader and the fourth threader being configured to dispose the scaffold onto the same suture as the second threader. More particularly, the association of the third and fourth threaders with the same suture as the first and second threaders, respectively, can be configured to be achieved by associating the respective suture with the distal receiving end of the respective third and fourth threaders and applying a force to the proximal handle of the respective third and fourth threaders to advance the respective distal receiving end towards the scaffold. The third and fourth threaders can be disposed in the scaffold such that the distal receiving ends of the third and fourth threaders are disposed on a tissue-engaging face of the scaffold and the proximal handles of the third and fourth threaders are disposed on a face of the scaffold that is opposite of the tissue-engaging face.
• A limb of the suture onto which the scaffold is disposed by the first and third threaders can include a first loop that extends from the tissue-engaging face, around an edge of the scaffold to the face of the scaffold that is opposed to the tissue-engaging face, and into the scaffold at a first location on the scaffold, and a limb of the suture onto which the scaffold is disposed by the second and fourth threaders can include a second loop that extends from the tissue-engaging face, around the edge of the scaffold to the face of the scaffold that is opposed to the tissue-engaging face, and into the scaffold at a second location on the scaffold in a post-installation configuration of the system. Alternatively, a limb of the suture onto which the scaffold is disposed by the first and third threaders can include a first loop that extends from the tissue-engaging face of the scaffold, to the face of the scaffold that is opposed to the tissue-engaging face, and into the scaffold at a first location on the scaffold that is offset from an edge of the scaffold, and a limb of the suture onto which the scaffold is disposed by the second and fourth threaders can include a second loop that extends from the tissue-engaging face of the scaffold, to the face of the scaffold that is opposed to the tissue-engaging face, and into the scaffold at a second location that is offset from the edge of the scaffold in a post-installation configuration of the system.
• The scaffold can have a variety of configurations, shapes, and sizes, and can be made of a variety of materials. In some embodiments, the scaffold can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, the scaffold includes collagen. The scaffold can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skill in the art or otherwise provided for herein. Still further, in some embodiments a first layer of the scaffold can include a biodegradable polymer, and a second layer of the scaffold can include an extracellular matrix. A thickness of the first layer can be greater than a thickness of the second layer. Further, in some embodiments, the scaffold can include one or more adjustable suture loops disposed on an edge of the scaffold, the adjustable suture loop(s) being configured to prevent the scaffold from unintentionally sliding with respect to a suture limb passed through the respective adjustable suture loop(s).
• In another exemplary embodiment of a soft tissue repair system, the system includes a scaffold and two sets of suture limbs. The scaffold has a first layer of material, and includes a tissue-facing surface and a second surface that is opposed to the tissue-facing surface, as well as a medial edge and an opposed lateral edge. The first set of suture limbs includes a first suture limb and a second suture limb that are disposed through the scaffold between the tissue-facing surface and the second surface along a length of the scaffold that extends substantially between the medial and opposed lateral edges. The second set of suture limbs includes a third suture limb and a fourth suture limb that are disposed above the tissue-facing surface of the scaffold. The system is configured such that a terminal lateral end of one of the first and second suture limbs and a terminal lateral end of one or the third and fourth suture limbs are disposed proximate to each other on a first side of the scaffold, and a terminal lateral end of the other of the first and second suture limbs and a terminal lateral end of the other of the third and fourth suture limbs are disposed proximate to each other on a second side of the scaffold. The first and second sides of the scaffold are distinguished by being on opposite sides of a central longitudinal axis of the scaffold that extends between the medial and lateral edges. Further, at least one of the first and second suture limbs extends through the scaffold from the tissue-facing surface to the second surface and then, for that suture limb, forms at least one stitch that passes a terminal lateral end of the suture limb through the scaffold to and through the lateral edge. Optionally, a stitch of that nature, or similar to that nature, can also be formed with at least one of the third and fourth suture limbs.
• The scaffold can include a second layer of material disposed above the first layer of material such that the second layer of material is disposed above the tissue-facing surface of the scaffold and the second layer of material includes the second surface of the scaffold. In such embodiments, the first suture limb and the second suture limb can be disposed between a top-most surface of the first layer of material that is opposed to the tissue-facing surface of the scaffold and a tissue-facing surface of the second layer of material that is opposed to the second surface of the scaffold.
• In some embodiments, the first and second suture limbs can be disposed on opposite sides of the central longitudinal axis of the scaffold such that the first and second suture limbs do not intersect at locations at which the first and second suture limbs are disposed through the scaffold between the tissue-facing surface and the second surface. In some such embodiments, the third and fourth suture limbs can be disposed with respect to the central longitudinal axis of the scaffold such that the third and fourth suture limbs cross over the central longitudinal axis at least once and intersect each other at least once at a location at which the third and fourth suture limbs are disposed above each of the tissue-facing surface and the second surface. In some other such embodiments, the third and fourth suture limbs can be disposed on opposite sides of the central longitudinal axis of the scaffold such that the first and fourth suture limbs do not intersect at location at which the third and fourth suture limbs are disposed above each of the tissue-facing surface and the second surface and are in contact with the second surface. The first set of the suture limbs can be disposed further from the central longitudinal axis than the second set of the suture limbs for portions of the limbs that extend between the medial and lateral edges. Alternatively, the second set of the suture limbs can be disposed further from the central longitudinal axis than the first set of the suture limbs for portions of the limbs that extend between the medial and lateral edges.
• In some other embodiments, the first and second suture limbs can be disposed with respect to the central longitudinal axis of the scaffold such that the first and second suture limbs cross over the central longitudinal axis at least once and intersect each other at least once at a location at which the first and second suture limbs are disposed through the scaffold between the tissue-facing surface and the second surface. In some such embodiments, the third and fourth suture limbs can be disposed with respect to the central longitudinal axis of the scaffold such that the third and fourth suture limbs also cross over the central longitudinal axis at least once and intersect each other at least once at a location at which the third and fourth suture limbs are disposed above each of the tissue-facing surface and the second surface. In some other such embodiments, the third and fourth suture limbs can be disposed on opposite sides of the central longitudinal axis of the scaffold such that the first and fourth suture limbs do not intersect at location at which the third and fourth suture limbs are disposed above each of the tissue-facing surface and the second surface and are in contact with the second surface.
• The third and fourth suture limbs can be disposed above the second surface of the scaffold. Further, in some embodiments, the third and fourth suture limbs can be in contact with the second surface of the scaffold. Alternatively, the third and fourth suture limbs can be disposed through the scaffold between the tissue-facing surface and the second surface along a portion of a length of the scaffold that extends between the medial and opposed lateral edges. Further alternatively, the third and fourth suture limbs can partially extend above the second surface of the scaffold and partially through the scaffold. For instance, a portion of the third and fourth suture limbs extending between the medial and opposed lateral edges can be disposed above the second surface of the scaffold and another portion of the third and fourth suture limbs can be disposed through the scaffold between the tissue-facing surface and the second surface along the portion of the length of the scaffold that extends between the medial and opposed lateral edges.
• The at least one stitch can include a loop in which the suture limb forming the loop passes around the medial edge and into the scaffold such that the terminal lateral end of the suture limb passes through the scaffold from the medial edge to and through the lateral edge. Alternatively, the at least one stitch can include a jog in which the suture limb forming the jog passes into the scaffold at an entry location on the second surface that is more proximate to the medial edge than the lateral edge along a longitudinal axis extending substantially parallel to the central longitudinal axis of the scaffold such that the terminal end of the suture limb passes through the scaffold approximately from the entry location to and through the lateral edge. At least one of the third and fourth suture limbs can also extend through the scaffold from the tissue-facing surface to the second surface and then, for that suture limb, form at least one stitch that passes a terminal lateral end of the suture limb through the scaffold to and through the lateral edge. The stitch can likewise be a loop or jog.
• The first set of suture limbs can extend from a first mattress stitch and a second set of suture limbs can extend from a second mattress stitch. The system can further include at least one additional suture having a fifth suture limb and a sixth suture limb. In some embodiments, the fifth and sixth suture limbs can extend from a central medial mattress stitch, while in some other embodiments the fifth and sixth suture limbs can extend from a central lateral mattress stitch. In still further embodiments, suture limbs can extend from each of a central medial mattress stitch and a central lateral mattress stitch. Whether a central medial or lateral mattress stitch, the system can be configured such that a terminal lateral end of one of the fifth and sixth suture limbs can be disposed proximate to the terminal lateral ends of the respective first, second, third, and fourth suture limbs that are disposed on the first side of the scaffold, and a terminal lateral end of the other of the fifth and sixth suture limbs can be disposed proximate to the terminal lateral ends of the respective first, second, third, and fourth suture limbs that are disposed on the second side of the scaffold.
• Exemplary methods of soft tissue repair that include using a patch or scaffold are also disclosed. One exemplary method includes passing each of a first suture limb and a second suture limb through soft tissue and attaching a scaffold to each of the first and second suture limbs. This results in a surface area for engaging tissue associated with each of the first and second suture limbs being increased. A first end of the scaffold is advanced to a location that is proximate to locations through which the first and second suture limbs pass through the soft tissue, and one or more suture tails are coupled to at least one suture anchor that is disposed in the bone to which the soft tissue is being attached. In some embodiments, the one or more suture tails are part of suture from which the first and second limbs are formed, while in other embodiments the one or more suture tails are separate sutures from sutures that form the first and second suture limbs.
• The step of advancing a first end of the scaffold to a location that is proximate to locations through which the first and second suture passes through the soft tissue can included disposing a second, opposite end of the scaffold beyond the soft tissue such that it extends over bone to which the soft tissue is being attached. In some embodiments, the step of attaching a scaffold to each of the first and second suture limbs can include threading each of the first and second suture limbs from the first end of the scaffold to the second, opposite end of the scaffold, with the first suture limb being thread at a location that is more proximate to a first side of the scaffold than a second, opposite side of the scaffold and the second suture limb being thread at a location that is more proximate to the second, opposite side of the scaffold than the first side of the scaffold. In such embodiments, the step of coupling one or more suture tails with at least one suture anchor disposed in the bone to which the soft tissue is being attached can include coupling a first tail of the one or more suture tails with a first suture anchor disposed in the bone to which the soft tissue is being attached and coupling a second tail of the one or more suture tails with a second suture anchor disposed in the bone to which the soft tissue is being attached. The first suture limb can be of a first suture and the second suture limb can be of a second suture. In some embodiments, the step of attaching a scaffold to each of the first and second suture limbs can include disposing at least one of the first and second suture limbs through an opening of a loop disposed on an edge of the scaffold and collapsing the opening of the loop through which the first and/or second suture limbs are disposed around the respective limb(s) to prevent the scaffold from unintentionally sliding with respect to the limb(s) disposed through the opening.
• In embodiments having the first suture and the second suture, threading the first suture limb from the first end of the scaffold to the second, opposite end of the scaffold can include coupling the first suture limb to a threader disposed in the scaffold and applying a force to the threader to dispose the scaffold onto the first suture limb. Similarly, threading the second suture limb from the first end of the scaffold to the second, opposite end of the scaffold can include coupling the second suture limb to a threader disposed in the scaffold and applying a force to the threader to dispose the scaffold onto the second suture limb.
• In embodiments having the first suture and the second suture, the method can include installing a first medial row stitch using the first suture, and installing a second medial row stitch using the second suture. Further, the step of coupling one or more suture tails with at least one suture anchor disposed in the bone to which the soft tissue is being attached can include installing a lateral row fixation.
• The step of attaching a scaffold to each of the first and second suture limbs can include disposing the first suture limb through the scaffold from a tissue-engaging face of the scaffold to a face of the scaffold that is opposed to the tissue-engaging face, with the disposing of the first suture limb occurring at a first location on the scaffold that is proximate to a proximal edge of the scaffold. The attachment step can further include passing the first suture limb around the proximal edge of the scaffold and into the scaffold through the proximal edge to form a first loop, and passing the first suture limb through the scaffold from the proximal edge to a distal edge of the scaffold. The step can also include disposing the second suture limb through the scaffold from the tissue-engaging face of the scaffold to the face of the scaffold that is opposed to the tissue-engaging face, with the disposing of the second suture limb occurring at a second location on the scaffold that is proximate to the proximal edge of the scaffold. The attachment step can still further include passing the second suture limb around the proximal edge of the scaffold and into the scaffold through the proximal edge to form a second loop, and passing the second suture limb through the scaffold from the proximal edge to the distal edge of the scaffold.
• Alternatively, the step of attaching a scaffold to each of the first and second suture limbs can include disposing the first suture limb through the scaffold from a tissue-engaging face of the scaffold to a face of the scaffold that is opposed to the tissue-engaging face, with the disposing of the first suture limb occurring at a first location on the scaffold that is proximate to a proximal edge of the scaffold. The attachment step can further include passing the first suture limb back into the scaffold through the face of the scaffold that is opposed to the tissue-engaging face, with the passing of the first suture limb back into the scaffold occurring at a second location on the scaffold that is offset from the first location to form a first stitch. The attachment step can also include passing the first suture limb through the scaffold from the second location to a distal edge of the scaffold. The attachment step can still further include disposing the second suture limb through the scaffold from the tissue-engaging surface of the scaffold to the face of the scaffold that is opposed to the tissue-engaging face, with the disposing of the second suture limb occurring at a third location on the scaffold that is proximate to the proximal edge of the scaffold. The attachment step can also include passing the second suture limb back into the scaffold through the face of the scaffold that is opposed to the tissue-engaging face, with the passing of the second suture limb back into the scaffold occurring at a fourth location on the scaffold that is offset from the third location to form a second stitch. Still further, the attachment step can include passing the second suture limb through the scaffold from the fourth location to the distal edge of the scaffold.
• The first suture can include a third suture limb and the second suture can include a fourth suture limb. In such embodiments, which also include the first and second suture anchors, the method can further include passing the third suture limb over the scaffold and coupling it to the second suture anchor, and passing the fourth suture limb over the scaffold and coupling it to the first suture anchor. Further, a first medial anchor to which the first suture is coupled and a second medial anchor to which the second suture is coupled can be installed such that the first and third suture limbs extend from the first medial anchor and the second and fourth suture limbs extend from the second medial anchor.
• In other embodiments that include the third and fourth suture limbs, the method can include threading the third suture limb from the first end of the scaffold to the second, opposite end of the scaffold and coupling the third suture limb to the second suture anchor. Similarly, the fourth suture limb can be threaded from the first end of the scaffold to the second, opposite end of the scaffold and coupled to the first suture anchor. The resulting configuration can be a crossed configuration between the third and fourth suture limbs. Further, a first medial anchor to which the first suture is coupled and a second medial anchor to which the second suture is coupled can be installed such that the first and third suture limbs extend from the first medial anchor and the second and fourth suture limbs extend from the second medial anchor.
• Carrying forward with some embodiments having four suture limbs, threading the first suture limb from the first end of the scaffold to the second, opposite end of the scaffold can include coupling the first suture limb to a threader disposed in the scaffold and applying a force to the threader to dispose the scaffold onto the first suture limb. Similarly, threading each of the second, third, and fourth suture limbs from the first end of the scaffold to the second, opposite end of the scaffold can include coupling the second, third, and fourth suture limbs to respective threaders disposed in the scaffold and applying a force to each of the threader to dispose the scaffold onto each of the second, third, and fourth suture limbs.
• In some embodiments, the first suture limb can be coupled to a first medial location on the scaffold and can include a hollow self-locking mechanism with a first threader disposed in that hollow self-locking mechanism, and the second suture limb can be coupled to a second medial location on the scaffold and can include a hollow self-locking mechanism with a second threader disposed in that hollow self-locking mechanism. In such embodiments the method can include coupling a leading tail of the first suture limb to the soft tissue and subsequently to the first threader, and coupling a leading tail of the second suture limb to the soft tissue and subsequently to the second threader. The first and second threaders can be moved with respect to the hollow self-locking mechanisms of the respective first and second suture limbs to pass the leading tail of the first and second suture limbs through the hollow self-locking mechanisms of that same limb. The step of advancing a first end of the scaffold to a location that is proximate to locations through which the first and second limbs pass through the tissue can include applying a force to the leading tails for the first and second suture limbs after they have passed through the respective hollow self-locking mechanism to advance the first end of the scaffold. Further, the step of coupling the one or more suture tails with at least one suture anchor disposed in the bone to which the soft tissue is being attached can include coupling a first trailing tail of the one or more suture tails to one of a first and second suture anchor of the at least one suture anchor disposed in the bone to which the soft tissue is being attached, and coupling a second trailing tail of the one or more suture tails to the other of the first and second suture anchors of the at least one suture anchor disposed in the bone to which the soft tissue is being attached. In some embodiments, the first trailing tail is part of the first suture and the second trailing tail is part of the second suture. In some other embodiments, the first trailing tail and the second trailing tail are separate sutures than the first and second sutures.
• In some other embodiments having four suture limbs, the first suture limb can be coupled to the scaffold at a first medial location on the scaffold and can include a hollow self-locking mechanism with a first threader disposed in that hollow self-locking mechanism, and the second suture limb can be coupled to the scaffold at a second medial location on the scaffold and can include a hollow self-locking mechanism with a second threader disposed in that hollow self-locking mechanism. Further, a third suture limb of a third suture can be coupled to the scaffold proximate to the first medial location on the scaffold and a fourth suture limb of a fourth suture can be coupled to the scaffold proximate to the second medial location on the scaffold. The third and fourth suture limbs can each include a hollow self-locking mechanism having third and fourth threaders disposed in the hollow self-locking mechanisms of the respective third and fourth limbs. In such embodiments the method can include coupling a leading tail of the first suture limb to the soft tissue and subsequently to the first threader, and coupling a leading tail of the second suture limb to the soft tissue and subsequently to the second threader. The first and second threaders can be moved with respect to the hollow self-locking mechanisms of the respective first and second suture limbs to pass the leading tail of the first and second suture limbs through the hollow self-locking mechanisms of that same limb. The step of advancing a first end of the scaffold to a location that is proximate to locations through which the first and second limbs pass through soft tissue can include applying a force to the leading tails for the first and second suture limbs after they have passed through the respective hollow self-locking mechanism to advance the first end of the scaffold. Further, the step of coupling the one or more suture tails with at least one suture anchor disposed in the bone to which the soft tissue is being attached can include coupling the leading tail of the third suture limb to a collapsible loop coupled to a first suture anchor of the at least one suture anchor disposed in the bone to which the soft tissue is being attached and subsequently to the third threader, and coupling the leading tail of the fourth suture limb to a collapsible loop coupled to a second suture anchor of the at least one suture anchor disposed in the bone to which the soft tissue is being attached and subsequently to the fourth threader. The third and fourth threaders can be moved with respect to the hollow self-locking mechanisms of the respective third and fourth suture limbs to pass the leading tail of the third and fourth suture limbs through the hollow self-locking mechanisms of that same limb. A force can be applied to the leading tails of the third and fourth suture limbs after they have passed through the respective hollow self-locking mechanism to advance the second, opposite end of the scaffold towards the bone to which the soft tissue is being attached.
• In some embodiments, the scaffold can include at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, a biological autograft, allograft, allogenic, xenogeneic, or xenograft, connective tissue including human dermal matrix, acellular porcine dermal matrix, acellular bovine dermal matrix, periosteal tissue, pericardial tissue, and/or fascia, and combinations thereof. In some embodiments, the scaffold includes collagen. The scaffold can be woven, non-woven, knitted, or manufactured using a variety of techniques known to those skilled in the art or otherwise provided for herein.
• In yet another exemplary embodiment, a soft tissue suture repair system includes a suture filament and a tissue augmentation tack. The suture filament includes a collapsible loop defined by a self-locking mechanism configured to adjust a size of the collapsible loop by moving along a length of the suture filament. The suture filament further includes a first tail and a second tail, the first and second tails extending from an opposite side of the self-locking mechanism than the collapsible loop extends from the self-locking mechanism. At least one of the first and second tails is actuable to move the self-locking mechanism along a length of the suture filament to adjust the size of the collapsible loop. The tissue augmentation tack is coupled to the suture filament. The tissue augmentation tack has a diameter that is at least two times greater than a diameter of the suture filament.
• The tissue augmentation tack can be coupled at least one of the first and second tails, and it can be disposed on the opposite side of the self-locking mechanism from the collapsible loop. In some embodiments, the system can further include a guide having a lumen extending from a proximal end of the guide to a distal end of the guide. The lumen can be configured to receive an inserter tool for inserting an anchor coupled to the collapsible loop to a surgical site. In some such embodiments, the guide can include a slot formed in an outer surface of the guide, with the slot being configured to receive the suture filament. Further, the slot can extend an entire length of guide, from the proximal end to the distal end.
• The system can include an anchor coupled to the collapsible loop. The anchor can have many different configurations. For example, the anchor can be a toggle anchor. In a further example, the anchor can be a soft anchor formed of a flexible construct. The soft anchor can be actuable from an unstressed configuration, in which the soft anchor has a first length and a first diameter, to a stressed configuration, in which the soft anchor has a second length that is less than the first length and a second diameter that is greater than the first diameter. The first tail can be actuable to move the self-locking mechanism along a length of the suture filament to adjust the size of the collapsible loop, and a locking knot can be formed by part of the second tail to fix a location of the tissue augmentation tack with respect to the suture filament. In some embodiments, the diameter of the tissue augmentation tack can be at least three times greater than a diameter of the suture filament.
• The tissue augmentation tack can include one or more materials, including at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, and fascia. In some such embodiments, the tissue augmentation tack includes collagen.
• Exemplary methods of soft tissue repair that include using a tissue augmentation tack are also disclosed. In one exemplary embodiment, the surgical method includes inserting an anchor coupled to a collapsible loop of a surgical filament into bone, disposing the collapsible loop through tissue adjacent to the bone, and applying tension to a first tail of the surgical filament to collapse the collapsible loop, thereby drawing a tissue augmentation tack coupled to the surgical filament towards the tissue and bone such that the tissue augmentation tack applies a force to the tissue to draw the tissue towards the bone. The tissue augmentation tack has a diameter that is at least two times greater than a diameter of the suture filament. The method further includes locking a location of the tissue augmentation tack with respect to the bone to set the location of the tissue with respect to the bone.
• In some embodiments the method can further include positioning a distal end of a guide adjacent to the tissue. In such embodiments, inserting an anchor coupled to a collapsible loop of a surgical filament into bone can further include passing the anchor through the guide. Further, the method can include advancing a punch through the guide to form a hole in the tissue. In such embodiments, disposing the collapsible loop through tissue adjacent to the bone can further include passing the collapsible loop through the hole in the tissue. Still further, the punch can be advanced through the guide to form a hole in the bone. In such embodiments, inserting an anchor coupled to a collapsible loop of a surgical filament into bone can further include inserting the anchor into the hole in the bone.
• In some embodiments, the method can include inserting a portion of the collapsible loop into a slot formed in an outer surface of the guide to assist in managing the suture filament during performance of the method. The slot can extend an entire length of the guide, between its proximal and distal ends. Further, the guide can be removed before applying tension to the first tail of the surgical filament to collapse the collapsible loop.
• The surgical method can further include toggling the anchor to set a location of the anchor with respect to the bone. In some embodiments, the anchor can be a soft anchor formed of a flexible construct. In such instances, the method can include actuating the anchor from an unstressed configuration to a stressed configuration to set a location of the anchor with respect to the bone. In some embodiments, the diameter of the tissue augmentation tack can be at least three times greater than a diameter of the suture filament. Further, the tissue augmentation tack can include one or more materials, including at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, and fascia. In some such embodiments, the tack can include collagen.
• Unless otherwise specified, the steps of the methods provided for in the present disclosure can be performed in any order.
BRIEF DESCRIPTION OF DRAWINGS
• FIG. 1A is a top view of one exemplary embodiment of a tissue augmentation construct;
• FIG. 1B is a side view of the tissue augmentation construct ofFIG. 1A;
• FIG. 2A is a perspective side view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 2B is a side view of the tissue augmentation construct ofFIG. 2A having a threader disposed therein;
• FIG. 2C is a perspective view of the tissue augmentation construct ofFIG. 2B;
• FIG. 2D is a front view of the tissue augmentation construct ofFIG. 2A;
• FIG. 2E is a perspective view of yet another exemplary embodiment of a tissue augmentation construct;
• FIG. 2F is a perspective view of still another exemplary embodiment of a tissue augmentation construct;
• FIG. 2G is a side view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 2H is a side view of still another exemplary embodiment of a tissue augmentation construct;
• FIG. 2I is a side view of yet another exemplary embodiment of a tissue augmentation construct;
• FIG. 3 is a side view of one exemplary tissue augmentation construct installation tool, the tool having a tissue augmentation similar to the tissue augmentation construct ofFIG. 2A associated therewith;
• FIG. 4 is a perspective view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 5 is a perspective view of still another exemplary embodiment of a tissue augmentation construct;
• FIGS. 6A-6C are schematic sequential views of one exemplary embodiment for installing tissue augmentation constructs in a double row fixation;
• FIGS. 7A-7D are schematic sequential views of another exemplary embodiment for installing tissue augmentation constructs in a double row fixation;
• FIG. 8A is a schematic view of still another exemplary embodiment for installing tissue augmentation constructs in a double row fixation;
• FIG. 8B is a schematic view of another exemplary embodiment for installing tissue augmentation constructs in a double row fixation;
• FIG. 9 is a schematic view of yet another exemplary embodiment for installing tissue augmentation constructs in a double row fixation;
• FIGS. 10A-10E are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 2G in a double row fixation;
• FIGS. 11A-11C are schematic sequential views of one exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 11D is a schematic view of another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 11E is a schematic view of still another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 11F is a schematic view of another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 12 is a schematic view of yet another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 13 is a schematic view of another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 14 is a schematic view of still another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIG. 15 is a schematic view of another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIGS. 16A-16C are schematic views of yet another exemplary embodiment for installing tissue augmentation constructs in a single row fixation;
• FIGS. 17A-17D are schematic sequential views of one exemplary embodiment for repairing soft tissue;
• FIGS. 18A-18C are schematic sequential views of another exemplary embodiment for repairing soft tissue;
• FIG. 19 is a schematic view of still another exemplary embodiment for repairing soft tissue;
• FIGS. 20A-20C are schematic sequential views of another exemplary embodiment for repairing soft tissue;
• FIGS. 20D-20F are schematic sequential views of yet another exemplary embodiment for repairing soft tissue;
• FIG. 21A is a schematic view of an exemplary embodiment of a tissue augmentation construct;
• FIGS. 21B-21F are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 21A;
• FIG. 21G is a schematic view of another exemplary embodiment for installing the tissue augmentation constructs ofFIG. 21A;
• FIG. 21H is a schematic view of an alternative exemplary embodiment of the tissue augmentation construct ofFIG. 21A;
• FIG. 21I is a schematic view of another alternative exemplary embodiment of the tissue augmentation construct ofFIG. 21A;
• FIG. 21J is a schematic view of an alternative exemplary embodiment of the tissue augmentation construct ofFIG. 21A and an inserter;
• FIG. 21K is a side view of one exemplary embodiment of a guide for use in conjunction with a tissue augmentation construct, such as the tissue augmentation construct ofFIG. 21J;
• FIG. 21L is a side view of one exemplary embodiment of a punch for use in conjunction with the guide ofFIG. 21K;
• FIGS. 21M-21R are schematic sequential views of one exemplary embodiment for installing the suture construct ofFIG. 21J using the inserter ofFIG. 21J, the guide ofFIG. 21K, and the punch ofFIG. 21L;
• FIGS. 22A-22C are schematic sequential views of one exemplary embodiment for manufacturing the tissue augmentation construct ofFIG. 2A;
• FIG. 23A is a front view of a plurality of tissue augmentation constructs during an exemplary embodiment for manufacturing tissue augmentation constructs;
• FIG. 23B is a top view of the plurality of tissue augmentation constructs ofFIG. 23A;
• FIG. 23C is a front view of one tissue augmentation construct of the plurality of tissue augmentation constructs ofFIG. 23A;
• FIG. 24A is a front view of a plurality of tissue augmentation constructs during another exemplary embodiment for manufacturing tissue augmentation constructs;
• FIG. 24B is a top view of the plurality of tissue augmentation constructs ofFIG. 23A;
• FIG. 24C is a front view of one tissue augmentation construct of the plurality of tissue augmentation constructs ofFIG. 23A;
• FIG. 25 is a side view of one exemplary embodiment of a distal end of a tool for manufacturing the tissue augmentation construct ofFIG. 2A;
• FIGS. 26A-26C are schematic sequential views of another exemplary embodiment for manufacturing a tissue augmentation construct;
• FIG. 26D is a side view of one tissue augmentation construct that can result from the manufacturing process illustrated inFIGS. 26A-26C;
• FIG. 26E is a side view of an alternative tissue augmentation construct that can result from the manufacturing process illustrated inFIGS. 26A-26C;
• FIG. 26F is a top view of the tissue augmentation construct ofFIG. 26E;
• FIGS. 26G-26I are schematic sequential views of yet another exemplary embodiment for manufacturing a tissue augmentation construct;
• FIG. 27A is a schematic side view of one exemplary embodiment of a tunneling station for use in manufacturing a tissue augmentation construct;
• FIGS. 27B and 27C are side schematic views of a support of the tunneling station ofFIG. 27A;
• 27D-27I are various exemplary embodiments of distal ends of lumen formation tools that can be used in conjunction with the tunneling station ofFIG. 27A;
• FIGS. 27J-27L are schematic sequential views of one exemplary embodiment for manufacturing a tissue augmentation construct using the tunneling station ofFIG. 27A;
• FIG. 27M is a schematic side view of another exemplary embodiment of a tunneling station for use in manufacturing a tissue augmentation construct;
• FIG. 28 is a side view of one exemplary embodiment of a tissue augmentation construct;
• FIG. 29A is a perspective view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 29B is a perspective view of the tissue augmentation construct ofFIG. 29A installed at a surgical site;
• FIG. 30A is a side view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 30B is a top view of the tissue augmentation construct ofFIG. 30A;
• FIGS. 30C-30E are schematic sequential views of an exemplary embodiment for manufacturing the tissue augmentation construct ofFIG. 30A;
• FIG. 30F is a schematic view of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 30A;
• FIGS. 30G-30I are schematic sequential views of one exemplary embodiment for installing a tissue augmentation construct similar to that ofFIG. 30A;
• FIG. 30J is a perspective view of still another exemplary embodiment of a tissue augmentation construct, the tissue augmentation construct having collapsible loops disposed thereon;
• FIG. 30K is a perspective view of the tissue augmentation construct ofFIG. 30J having suture limbs passed through the collapsible loops;
• FIG. 30L is a schematic view of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 30J;
• FIG. 31A-31C are schematic sequential views of a further exemplary embodiment for manufacturing a tissue augmentation construct;
• FIG. 32A is a top view of still another exemplary embodiment of a tissue augmentation construct;
• FIGS. 32B-32E are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 32A;
• FIGS. 32F-32H are schematic sequential views of one exemplary embodiment for installing a tissue augmentation construct similar to that ofFIG. 32A;
• FIGS. 32I-32J are schematic sequential views of one exemplary embodiment for manufacturing the tissue augmentation construct ofFIG. 32A;
• FIGS. 33A-33E are schematic top views of various exemplary embodiments of tissue augmentation constructs and suture configurations;
• FIG. 34A is a top view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 34B is a side view of the tissue augmentation construct ofFIG. 34A;
• FIGS. 34C-34J are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 34A;
• FIG. 34K is a schematic view of another exemplary embodiment for installing the tissue augmentation construct ofFIG. 34A;
• FIG. 35A is a top view of still another exemplary embodiment of a tissue augmentation construct;
• FIG. 35B is a side view of the tissue augmentation construct ofFIG. 35A;
• FIGS. 35C and 35D are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 35A;
• FIG. 36A is a top view of another exemplary embodiment of a tissue augmentation construct;
• FIG. 36B is a side view of the tissue augmentation construct ofFIG. 36A;
• FIGS. 36C-36I are schematic sequential views of one exemplary embodiment for installing the tissue augmentation construct ofFIG. 36A;
• FIGS. 37A-37E are schematic sequential views of one exemplary embodiment for installing a tissue augmentation construct;
• FIG. 38A is a top view of one exemplary embodiment of a tissue augmentation construct management device;
• FIG. 38B is a bottom view of the tissue augmentation construct management device ofFIG. 38A;
• FIG. 38C is a schematic side view of a release mechanism of the tissue augmentation construct management device ofFIG. 38A;
• FIG. 38D is a schematic side view of an alternative exemplary release mechanism that can be used in conjunction with a tissue augmentation construct management device like the device ofFIG. 38A;
• FIG. 38E is a top view of another exemplary embodiment of a tissue augmentation construct management device;
• FIG. 38F is a perspective exploded view of the tissue augmentation construct management device ofFIG. 38E;
• FIG. 38G is a top view of a threader of the tissue augmentation construct management device ofFIG. 38A;
• FIG. 38H is a rear perspective view of the threader ofFIG. 38G;
• FIGS. 39A-39F are schematic sequential views illustrating a method for using still another exemplary embodiment of a tissue augmentation construct management device;
• FIG. 40 is a perspective view of another exemplary embodiment of a tissue augmentation construct management device;
• FIG. 41A is a perspective view of another exemplary embodiment of a tissue augmentation construct;
• FIGS. 41B-41D are various exemplary embodiments of distal ends of delivery tools that can be used with the tissue augmentation construct ofFIG. 41A;
• FIG. 41E is a perspective view of the delivery tool ofFIG. 41B being used to deliver the tissue augmentation construct ofFIG. 41A;
• FIG. 42A is a side cross sectional view of yet another exemplary embodiment of a delivery tool for delivering a tissue augmentation construct;
• FIGS. 42B and 42C are schematic sequential views of the delivery tool ofFIG. 42A being used to deliver a tissue augmentation construct; and
• FIG. 43 is a schematic view of one exemplary embodiment of a suture leader.
DETAILED DESCRIPTION
• Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present disclosure is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure. Further, in the present disclosure, like-numbered components of the embodiments generally have similar features. Additionally, to the extent that linear or circular dimensions are used in the description of the disclosed systems, devices, and methods, such dimensions are not intended to limit the types of shapes that can be used in conjunction with such systems, devices, and methods. A person skilled in the art will recognize that an equivalent to such linear and circular dimensions can easily be determined for any geometric shape. Sizes and shapes of the systems and devices, and the components thereof, can depend at least on the anatomy of the subject in which the systems and devices will be used, the size and shape of components with which the systems and devices will be used, and the methods and procedures in which the systems and devices will be used.
• The figures provided herein are not necessarily to scale. Still further, to the extent arrows are used to describe a direction of movement, these arrows are illustrative and in no way limit the direction the respective component can or should be moved. A person skilled in the art will recognize other ways and directions for creating the desired result in view of the present disclosure. Additionally, a number of terms may be used throughout the disclosure interchangeably but will be understood by a person skilled in the art. By way of non-limiting example, the terms suture, filament, and flexible members may be used interchangeably, and includes other similarly purposed materials, such as suture tape. Further, to the extent the term “block” is used to describe some of the constructs and matrices provided for herein, the constructs and matrices are not limited to a square or a rectangle, or any shape having flat surfaces for that matter. Still further, to the extent the term “thread” is used to describe associating one component with another, the term is not limited to mean actually passing filament through another material. It can also include passing it through an opening (e.g., an opening formed in a body, as described below at least with respect to some tissue augmentation blocks), and thus can more generally mean associating one component with another.
• Systems, devices, and methods for soft tissue repair are generally provided, with such systems or devices including but not being limited to: one or more surgical repair filaments and/or flexible members; one or more tissue augmentation constructs or matrices, which include strips, tubes, bars, tacks, washers, and/or patches, each of which is described in greater detail below; and one or more suture implants or similarly configured or purposed devices. The terms “tissue augmentation construct” and “tissue augmentation matrix” may also be interchangeably used with the terms “suture augmentation construct” and “suture augmentation matrix,” as well as more generally with the terms “augmentation construct” and “augmentation matrix,” and the terms “construct” and “matrix.” As described herein, the term “construct” refers to any implant associated with suture limbs to expand the footprint of the limb, the term “block” refers to a subset of constructs that includes strips or tapes, tubes, bars, washers, and other cannulated bodies, and the terms “tack” or “button,” and “patches” or “scaffold” are described in greater detail below (as are the terms strips, tapes, tubes, bars, and washers, among others). Surgical repair filaments or flexible members can come in a variety of configurations including in typical suture configurations and tape forms, and can be used in connection with a variety of types of suture implants, e.g., filament anchors, suture anchors, or bone anchors, including hard and soft anchors, to attach or reattach soft tissue to bone. The repair filaments can pass through soft tissue so that the soft tissue can be positioned in a desired location. The repair filaments are secured to anchors which, in turn, are fixed in bone. The tissue augmentation construct(s) can be associated with the surgical repair filaments to increase coverage and bulk to compromised or degenerate soft tissue, to increase a surface area along which compression between the suture repair filament and tissue being repaired is applied, and to help promote tissue growth and repair. While each of the repair filament, tissue augmentation construct, and suture implant is described as being part of the systems or devices, any one component can be provided for separately for use with the other components or other implants and devices used in surgical procedures.
• While many different repair procedures can be enhanced by the present disclosures, in some exemplary embodiments the soft tissue repair devices and systems provided for herein can be used for rotator cuff fixation procedures. In rotator cuff fixation procedures a surgeon can reattach the rotator cuff to the bone by first threading a suture through the soft tissue such that two suture limbs extend from the tissue. The surgeon can thread each of the suture limbs through respective tissue augmentation constructs, and subsequently fix the suture limbs to one or more bone anchors proximate to the tissue. The tissue augmentation constructs increase the surface area, or footprint, of the system that contacts the soft tissue. This enlarged footprint may disperse any loading forces on the soft tissue, and, as a result, the tensioned suture may be less likely to abrade or otherwise damage the soft tissue, for instance by “cheese wiring.” Moreover, the tissue augmentation constructs can be easily and quickly threaded onto or otherwise associated with suture limbs during the procedure, which contrasts from existing systems that involved complicated, time-intensive approaches for associating xenograft or allograft formations with suture limbs. The resulting procedures thus allow for the tissue augmentation constructs to be added onto suture limbs in an on-demand fashion. Still further, the tissue augmentation constructs can be made from biocompatible materials (e.g., collagen), among other types of materials, such that during healing new bands of tissue growth can occur, further increasing the efficacy of the rotator cuff fixation procedure. In other non-limiting exemplary embodiments disclosed herein, the soft tissue repair devices and systems can be used in other soft tissue repair procedures for example, repair of torn anterior cruciate ligament (ACL), instability or glenoid procedures, meniscal repair, superior capsule reconstruction, and hip capsular closure, among others. Various methods of manufacturing the tissue augmentation constructs, as well as using installation tools and/or threaders to associate tissue augmentation constructs with operative sutures are also described.
• Tissue Augmentation Constructs—Tissue Augmentation Blocks Having a Strip or Tape Configuration
• One exemplary embodiment of a tissue augmentation construct, as shown atissue augmentation block10, is provided for inFIGS. 1A and 1B. In one exemplary embodiment, thetissue augmentation block10 is a strip or tape configured to be threaded onto or otherwise associated with asuture limb12a. More particularly, the tissue augmentation strip ortape10 can have a substantially rectangular shape with a width W, length L, and thickness T, and includes a substantially flat, tissue-engagingsurface10aand/or10b. As shown, thetape10 is longer than it is wide and wider than it is thick. Typically the length L is substantially greater than the width W and the width W is substantially greater than the thickness T. Further, the width W can be greater than a diameter of a filament or suture with which thetissue augmentation tape10 is associated, e.g., thesuture limb12a, thereby increasing the surface area of compression of the system or device used in the surgical repair.
• A person skilled in the art will recognize that the dimensions of the length L, width W, and thickness T of thetissue augmentation strip10 can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments a ratio of the width W of thestrip10 to a diameter of thesuture limb12acan be approximately in the range of about 2:1 to about 20:1, and more particularly the width W can be at least three times greater than the diameter of the filament or suture with which thetissue augmentation strip10 is associated in some instances. In embodiments in which thesuture limb12ais a suture tape, the width W of thetissue augmentation strip10 can be at least two times greater than the diameter of the suture tape with which the strip is associated in some instances. A person skilled in the art will recognize that the ratio of the width of a tissue augmentation strip to diameter of the filament or related structure with which the strip is used can be any suitable ratio, depending, at least in part, on the type of filament or related structure being used, the type of strip or other construct being used, and the type of procedure being performed, and thus a ratio of width to diameter may be smaller or larger than those provided for herein. Further, in some embodiments a ratio of the width L of thestrip10 to the width W of thestrip10 can be approximately in the range of about 2:1 to about 20:1, and more particularly the length L can be at least three times greater than the width Win some instances, at least five times greater in some other instances, and at least ten times greater in some instances, although other L-W ratios are possible. Still further, thestrip10 can be substantially flat and approximately uniform. In some embodiments a ratio of the width W of thestrip10 to the thickness T of thestrip10 can be approximately in the range of about 2:1 to about 20:1, and more particularly the width W can be at least three times greater than the thickness T in some instances, at least five times greater in some other instances, and at least ten times greater in some instances, although other W-T ratios are possible. A variety of other sizes and shapes of the tissueaugmentation tape strip10, including ratios of the dimensions of the tissue augmentation strip and associated components (e.g., thesuture limb12a) can be utilized without departing from the spirit of the present disclosure.
• While ratios can be useful to help describe the relationship between thestrip10 and thefilament limb12a, and the relationship between the dimensions of thestrip10, some exemplary, non-limiting dimensions for a tissue augmentation strip can also be useful in understanding the present disclosure. As mentioned above, these dimensions can be dependent on a variety of factors. In some embodiments, the length L can cover a significant portion, to almost an entire portion, of a length of tissue extending between a stitch made in tissue and a bone anchor used to help secure the tissue. In some embodiments, the length L can be approximately in the range of about 5 millimeters to about 1 centimeter, the width W can be approximately in the range of about 1 millimeter to about 5 millimeters, and the thickness T can be approximately in the range of about 0.5 millimeter to about 3 centimeters. Further, while thestrip10 is described as having a length, width, and thickness, and it is shown as being substantially flat inFIG. 1A,FIG. 1B illustrates that thestrip10 can be relatively flexible, for instance it can be bunched in portions by the suture limb12 passing therethrough. Materials used to form thestrip10 are described in a later section of the present disclosure.
• A number of techniques can be used to associate thetissue augmentation strip10 with thesuture limb12a. As shown inFIG. 1B, thesuture limb12ais threaded from atop side10ato abottom side10band back to thetop side10aof thetissue augmentation strip10. The process of threading thesuture limb12athrough thetissue augmentation strip10 can be repeated as many times as desired. In some embodiments a suture threader can be threaded through thetissue augmentation strip10 ahead of a procedure so that the operative suture can be threaded through the tissue augmentation strip in vivo during the procedure. Exemplary suture threaders are discussed below with regards to alternative tissue augmentation constructs.
• While thetissue augmentation strip10 ofFIG. 1B is shown having an exaggerated, wave-like profile when engaged with thesuture limb12a, in practice thetissue augmentation strip10 can conform to the geometry of the soft tissue that it is contacting. By including thetissue augmentation strip10 on thesuture limb12a, thesuture limb12ahas a broader foot print, thus covering more surface area of the tissue. Further thetissue augmentation strip10 may allow force applied to the tissue by thesuture limb12ato be distributed over a larger amount of surface area. The larger amount can be dependent on the surface area of thetissue augmentation strip10. Thus, in embodiments where the width of thetissue augmentation strip10 is at least three times greater than the diameter of thesuture limb12a, the force of thesuture limb12aon the tissue may be distributed over an area that is at least three times greater than would otherwise be if notissue augmentation strip10 was associated with thesuture limb12a. The increased tissue surface area coverage and distributed force of thetissue augmentation strip10 may result in a reduced pressure peak on the soft tissue. In use, it is either thesurface10aor thesurface10bthat engages the tissue and may allow for the increased distribution. Where the soft tissue has become degenerated due to injury or age, a reduction in pressure can result in less chance of abrasion of the tissue. Further, the broader tissue coverage may enhance healing of otherwise compromised tissue.
• Thesuture limb12aused in conjunction with thetissue augmentation strip10 can be any type of suture (e.g., braided filament, cannulated filament, mono filament, suture tape, etc.) and can have a size between about a #5 filament (about 20 gauge to about 21 gauge) and about a #3-0 filament (about 29 gauge to about 32 gauge). A person skilled in the art will recognize a variety of other filament types and sizes that can also be used in conjunction with theaugmentation strip10, such as, if a suture tape is used.
• Tissue Augmentation Constructs—Tissue Augmentation Constructs Having a Cannulated Portion
• Another exemplary embodiment of a tissue augmentation construct, as shown atissue augmentation block110, is provided for inFIGS. 2A-2D. Alternatively, tissue augmentation constructs, likeblock110, can be referred to generally as tissue augmentation constructs having a cannulated body. Tissue augmentation constructs having a cannulated body can include thetube110,bars3010,3010′, andwashers310,410. In one exemplary embodiment of augmentation blocks, the blocks can be a cannulated tube configured to be disposed on or otherwise associated with asuture limb112a. More particularly, theaugmentation tube110 can have a substantially cylindrical, or ovoid, body with a bore orlumen114 extending therethrough from aproximal-most end110pto adistal-most end110d. To the extent theblock110 is described as a tube, such description in no way limits the configuration of the tissue augmentation blocks to being tubes or having a tubular construction. A tube-like configuration is one of a variety of configurations of blocks provided for herein or otherwise derivable herefrom. Other non-limiting embodiments of blocks include but are not limited to bars and washers, as further described below.
• Turning back to the cannulated nature of theblock110, thebore114 can be used, for example, to receive thesuture limb112aso that theblock110 andlimb112acan be associated with each other, as described in greater detail below. As shown, theblock110 has a length L′ that is greater than a diameter D, and in many instances substantially greater. Further, the diameter D can be greater than a diameter of a filament or suture with which thetissue augmentation block110 is associated, e.g., thesuture limb112a, thereby increasing the surface area of tissue augmentation of the system or device used in the surgical repair.
• A person skilled in the art will recognize that the dimensions of the length L′ and diameter D of thetissue augmentation tube110, as well as a diameter d of thebore114, can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments a ratio of the length L′ and the diameter D can be approximately in the range of about 2:1 to about 20:1, and more particularly the length L′ can be at least three times greater than the diameter D in some instances. Further, in some embodiments a ratio of the diameter D of thetube110 to a diameter of thesuture limb112acan be approximately in the range of about 2:1 to about 20:1, and more particularly the diameter D can be at least three times greater than the diameter of the filament or suture with which thetissue augmentation tube110 is associated in some instances. A variety of other sizes and shapes of thetissue augmentation tube110, including ratios of the dimensions of the tissue augmentation block and associated components (e.g., thesuture limb112a) can be utilized without departing from the spirit of the present disclosure.
• While ratios can be useful to help describe the relationship between thetube110 and thefilament limb112a, and the relationship between the dimensions of thetube110, some exemplary, non-limiting dimensions for a tissue augmentation tube can also be useful in understanding the present disclosure. As mentioned above, these dimensions can be dependent on a variety of factors. In some embodiments, the length L′ can cover a significant portion, to almost an entire portion, of a length of tissue extending between a stitch made in tissue and a bone anchor used to help secure the tissue. In some embodiments, the length L′ can be approximately in the range of about 5 millimeters to about 2 centimeter, and the diameter D can be approximately in the range of about 1 millimeter to about 5 millimeters. The size of the diameter d of thebore114 can also depend on a variety of factors, including but not limited to the size of the limb to be passed therethrough. In some embodiments, the diameter d can be approximately in the range of about 0.75 millimeters to about 3 millimeters.
• Alternative embodiments of tissue augmentation blocks110 having cannulated portions are shown inFIGS. 2E, 2F, 2G, 2H, and 2I. Not all tissue augmentation blocks have cannulated portions, although that is a common feature of theblocks110,3010,3110,2810a,2810′,2810″ provided for inFIGS. 2A-2I. Other configurations of tissue augmentation blocks do not have cannulated portions, or cannulated portions through which sutures limbs are passed, and thus other configurations can be associated with limbs using other techniques provided for herein otherwise known to those skilled in the art.
• As discussed above, and shown inFIGS. 2E and 2F, tissue augmentation bars3010,3110 can have a rectangular and/or square cross sectional shape. Other cross sectional shapes are possible and include, for example, triangular, quadrilaterals, pentagons, hexagons, octagons, etc. As shown inFIG. 2E, cannulatedbar3010 is configured to be disposed on or otherwise associated with a suture limb, as described above with respect to the cannulatedtube110. More particularly, thebar3010 can have a substantially rectangular body with a rectangular bore orlumen3014 extending therethrough from aproximal-most end3010pto adistal-most end3010d. Thebore3014 can be used, for example, to receive the suture limb so that thebar3010 and suture limb can be associated with each other, as described in greater detail below. It is contemplated that bore3014 can be created through manufacturing techniques discussed below with respect toaugmentation block110.
• An alternative construction oftissue augmentation bar3010,tissue augmentation bar3110, is shown inFIG. 2F. As shown inFIG. 2F, the cannulatedbar3110 is configured to be disposed on or otherwise associated with a suture limb, as described above with respect to the cannulatedblocks110,3110. More particularly, thebar3110 can have a substantially rectangular body with a rectangular bore orlumen3114 extending therethrough from aproximal-most end3110pto adistal-most end3110d. Thebore3114 can be used, for example, to receive the suture limb so that thebar3110 and suture limb can be associated with each other, as described in greater detail below. As shown,bar3110 can be constructed of two portions of material,3110a,3110b. The two pieces of material3110a,3110bcan be associated with each other by means ofsutures3124a,3124b. The pieces of material3110a,3110bcan be attached to each other such thatlumen3114 is formed using any manufacturing techniques discussed throughout the present disclosure. A variety of other sizes and shapes of thebars3010,3110 including ratios of the dimensions of the bar and associated components (e.g., the suture limb) can be utilized without departing from the spirit of the present disclosure.
• Further alternative configurations of tissue augmentation blocks2810a,2810′, and2810″ are illustrated inFIGS. 2G, 2H, and 2I, respectively. As shown, the cannulatedblocks2810a,2810′,2810″ can all be substantially the same astissue augmentation block110, as shown inFIGS. 2A-2D. Alternatively, the cannulatedblocks2810a,2810′,2810″ can have configurations substantially similar to the tissue augmentation bars3010,3110. The cannulated blocks2810a,2810′,2810″ can have a length that is substantially longer than the tissue augmentation blocks110. In one exemplary embodiment, theblock2810acan have a length approximately in the range of about 15.0 millimeters to about 25.0 millimeters. Advantageously, blocks2810a,2810′,2810″ can have a length that can extend from lateral anchors medially up and over a soft tissue repair to provide for additional protection for the repair and additional scaffolding to aid in healing.
• A number of techniques can be used to associate the tissue augmentation blocks110,3010,3110,2810a,2810′,2810″ with asuture limb112a. For example, as shown inFIG. 2A, thesuture limb112ais threaded or passed from theproximal-most end110pto thedistal-most end110dof thetissue augmentation tube110 without passing through, that is across, the body of thetube110. In other words, thesuture limb112adoes not pass into a sidewall of the body that defines thelumen114. As such, thetube110 is not coupled or attached to thesuture limb112a, and instead can freely pass along a length of thelimb112aunhindered or unrestricted. In other embodiments, thelimb112acan pass through, that is across, the body once or more to further secure a location of thetube110 with respect to thelimb112a, thereby coupling or attaching thetube110 to thesuture limb112a. A person skilled in the art will recognize a variety of other ways by which thetube110 can be associated or coupled with thelimb112awithout departing from the spirit of the present disclosure.
• Thetissue augmentation tube110 can be threaded by hand on to thesuture limb112a, either at the surgical site, or outside of the body. Alternatively, as shown inFIGS. 2B and 2C, thetissue augmentation tube110 can have athreader206 inserted through thebore114 prior to thetissue augmentation tube110 being threaded onto thesuture limb112a. Thethreader206 can include aproximal handle portion208, an intermediateelongate portion210, and a distal suture-receivingend212. Theproximal handle portion208 can be configured to be easily gripped by a user, for instance by having a substantially rectangular shape as shown. Other shapes and features for gripping can be provided. The intermediate portion can be afilament portion210 capable of having a tissue augmentation construct, e.g., thetissue augmentation tube110, associated therewith, thereby allowing thethreader206 to be flexible. The distal suture-receivingend212 can have adistal opening212 through which a suture to be associated with an augmentation strip, e.g.,suture limb112a, can be disposed. In the illustrated embodiment, thedistal opening212 is flexible and, in some embodiments, can be made of a wire, a fiber, a thread, a cord, and/or other flexible structure or other material having similar characteristics. Because thedistal opening212 is flexible, it can change shape before, during, and after use, and thus while in the illustrated embodiment it has a diamond or kite-shape, other configurations are possible. Further, the flexible nature of theopening212 can allow theopening212 to collapse around a suture disposed therein to strangulate or otherwise hold the suture during use. In some embodiments, theintermediate portion210 can also be made of a wire, a fiber, a thread, a cord, and/or other flexible structure. The term wire is not intended to imply that the structure is made of metal, or has metal characteristics, but theintermediate portion210 and the distal suture-receivingend212 can be made of metal.
• FIGS. 2G-2I provide for additional configurations of suture limbs being associated with tissue augmentation constructs. As shown inFIG. 2G, theconstruct2810acan include two threaders disposed therethrough for associating theconstruct2810awith at least one suture limb. As illustrated inFIG. 2G, afirst threader2809acan be disposed through theblock2810afrom atop surface2811tto a bottom surface2811asuch that thehandle2808ais proximate thetop surface2811tand the receivingend2807bis proximate thebottom surface2811b. Thefirst threader2809acan be disposed through theblock2810asuch that it intersects thecentral lumen2870 of theblock2810asubstantially perpendicularly relative thereto. Alternatively, thethreader2809acan be disposed at any angle relative to thecentral lumen2870. Thefirst threader2809acan be disposed at theproximal end2811p, or proximal half, of theblock2810a. Asecond threader2809bcan be disposed through adistal portion2811dof theblock2810a. For example thesecond threader2809bcan extend from adistal end2811dof theblock2810athrough thelumen2870 to a medial location2870mof the lumen and out of the bottom2811bof theblock2810a. In one exemplary embodiment thesecond threader2809bcan extend through theblock2810asuch that ahandle portion2808bof thethreader2809bis proximate thedistal end2811dof theblock2810aand the receivingend2807bof the threader extends out the bottom2811bof theblock2810a. Alternatively, other suture threader configurations are contemplated as shown inFIGS. 2H and 2I and discussed below.
• In one alternative suture threader configuration, as shown inFIG. 2I, block2810′ can include apre-threaded suture2814′ in theproximal end2811p′ of the block, obviating the need for a second threader. Thepre-threaded suture2814′ can be threaded intoblock2810′ at a location that is substantially similar to thesecond threader2809bofFIG. 2G. Thepre-threaded suture2014′ can be threaded into theblock2810′ either before or after the block is associated with a repair suture, not shown. In a further alternative configuration, as shown inFIG. 2H, block2810″ can include twothreaders2809a″ and2809b″. Thethreaders2809a″,2809b″ can be substantially similar tothreaders2809a,2809bdiscussed above. As shown, thesecond threader2809b″ can be disposed through acentral lumen2870″, for example from the proximalterminal end2811p″ to the distalterminal end2811d″. Alternatively, thesecond threader2809b″ can extend through any length of thecentral lumen2870″. Thesecond threader2809b″ can associate suture limbs, not shown, with theblock2810″ using techniques provided for throughout the present disclosure. The suture limbs can each exit theblock2810″ at thedistal end2811d″ along with a repair suture limb to be subsequently anchored into the bone at a location laterally offset from the soft tissue repair.
• In use, a force P₁can be applied to thehandle portion208 to move thefilament portion210 and thedistal opening212 in the direction of the force P₁with respect to theaugmentation tube110. Thedistal opening212, and thus thesuture limb112acoupled thereto, can be drawn into and through theaugmentation tube110 by way of this movement, thus disposing theaugmentation tube110 onto thesuture limb112a. As thedistal opening212 enters theaugmentation tube110, theopening212 can be collapsed, e.g., compressed to a smaller width, around thesuture limb112ato strangulate thelimb112a, thus making it easier for thesuture limb112ato be drawn into a body of theaugmentation tube110. Once theaugmentation tube110 is disposed on or is otherwise associated with thesuture limb112a, thesuture limb112acan be disassociated with thedistal opening212 and thethreader206 can be discarded or reused since it is no longer associated with either theaugmentation tube110 or thesuture limb112a. The combination of thesuture limb112aand theaugmentation tube110 can then be used in a variety of procedures, as detailed further below. The process of disposing theaugmentation tube110 onto thesuture limb112acan occur outside of the body or inside the body, including proximate to the surgical site.
• Similar to thetissue augmentation strip10, by including thetissue augmentation tube110 on thesuture limb112a, thesuture limb112ahas a broader footprint, thus covering more surface area of the tissue. Further, thetube110 may allow force applied to the tissue by thesuture limb112ato be distributed over a larger amount of surface area. The larger amount can be dependent on the surface area of thetissue augmentation tube110. Thus, in embodiments where the diameter of thetissue augmentation tube110 is at least three times greater than the diameter of thesuture limb112a, the force of thesuture limb112aon the tissue may be distributed over an area that is at least three times greater than would otherwise be if notissue augmentation tube110 was associated with thesuture limb112a. The increased tissue surface area coverage and distributed force of thetissue augmentation tube110 may result in a reduced pressure peak on the soft tissue. Where the soft tissue has become degenerated due to injury or age, an increased tissue surface area coverage and a reduction in pressure can result in less chance of abrasion of the tissue. Further, the broader tissue coverage may enhance healing of otherwise compromised tissue and/or provide bulk to otherwise compromised or degenerate tissue and/or tendon.
• Threaders like thethreader206 can also be used in conjunction with an installation tool to assist in associating an augmentation construct with a suture.FIG. 3 provides for athreader206′ that is similar to thethreader206 except that theproximal handle portion208′ and distal receivingend212′ have a slightly different shape. As shown, theproximal handle portion208′ is in the form of agripping protrusion208′ that has a diameter that is greater than a diameter of theintermediate filament portion210′, thus allowing a user to easily grip theproximal handle portion208′. A person skilled in the art will recognize that theproximal handle portion208′ can have most any shape. Likewise, a shape of the distal receivingend212′ can also have most any shape. In the illustrated embodiment, the distal receivingend212′ is adistal opening212′, but the opening is illustrated as being more rounded than thedistal opening212. However, as explained above, because thedistal opening212′ can be flexible, even the illustrated embodiments can be manipulated into other shapes.
• Theinstallation tool200′ can include ahandle portion202′ and acartridge portion204′. Thehandle portion202′ can be long such that theinstallation tool200′ can be inserted through a cannula into a surgical site inside of the body. Alternatively, thehandle portion202′ can be any suitable length. As shown inFIG. 3, thehandle202′ includes aproximate portion202p′ and adistal portion202d′. Thedistal portion202d′ of thehandle202′ can be angularly offset from theproximal portion202p′ to allow for thecartridge204′ to be oriented in a favorable orientation to thread theaugmentation tube110′ onto thelimb112a′. Alternatively, theproximal portion202p′ and thedistal portion202d′ can be in line with each other.
• Thedistal portion202d′ can be attached to acartridge204′ that is sized to receive anaugmentation tube110′ to be threaded ontosuture limb112a′. Thecartridge204′ can be cylindrical in shape, having an approximately circular cross section. Alternatively, thecartridge204′ can have a triangular, rectangular, or any other shape and/or cross section. Thecartridge204′ can have alumen214′ extending therethrough from afirst opening216′ to asecond opening218′. Thefirst opening216′ can be larger than thesecond opening218′. Alternatively, thefirst opening216′ and thesecond opening218′ can be any desired size. As shown inFIG. 3, thefirst opening216′ can have a diameter that is substantially the same as thelumen214′ such that theaugmentation tube110′ can be placed therethrough. Thesecond opening218′ can have a diameter that is sized to receive a relevant portion of thethreader206′ therethrough.
• As shown inFIG. 3, asuture limb112a′ is inserted through theopening212′ and thethreader206′ can be operated in a manner similar to thethreader206 to dispose theaugmentation tube110′ onto thesuture limb112a′. For example, an operator can grasp thehandle portion208′ of thethreader206′ to pull theopening212′ through thecannula114′ of theaugmentation tube110′ by the application of a force F_P′. Thehandle208′ can be pulled until the entirety of thethreader206′ and a distal portion of thesuture limb112a′ have passed through thesecond opening218′. Once thesuture limb112a′ has been threaded through theaugmentation tube110′, thethreaders206′ can be discarded or reused and the installation tool can release theaugmentation tube110′ by actuation of a release mechanism (not shown). Alternatively, theaugmentation tube110′ can be held in thecartridge204′ with an interference fit, such that no release mechanism is required. While reference is made toaugmentation tube110′ andsuture limb112a′, as noted above, theinstallation tool200′ can be used in the same manner withaugmentation strip10 ofFIGS. 1A-1B, as well as other constructs provided for herein. Further, while threaders are discussed as being used in conjunction with an installation tool, the threader itself can be considered an installation tool since embodiments provided for herein allow the threader to be used to associate a suture with an augmentation construct without using theinstallation tool200′.
• Tissue Augmentation Constructs—Tissue Augmentation Blocks Having a Washer, Disc, or Ring Configuration
• An exemplary embodiment of a tissue augmentation construct, as shown atissue augmentation block310, is provided for inFIG. 4. Theaugmentation block310 has a configuration that can be described as a washer, disc, or ring, and the illustrated embodiment it is a square-shaped washer configured to be disposed on or otherwise associated with asuture limb312a. For example, thewasher310 can have a substantially rectangular prism-shaped body with a bore orlumen314 extending therethrough from aproximal-most end310pto adistal-most end310d. Thebore314 can be used, for example, to receive thesuture limb312aso that thewasher310 andlimb312acan be associated with each other, as described in greater detail below. As shown, thewasher310 has a length L_Band a width W_Bwhich are substantially equal, and height T_Bwhich is less than the length L_Band the width W_B. Alternatively, thewasher310 can have a more elongated rectangular shape having a length L_Bthat is larger than the width W_B. In a further alternative, the length L_B, width W_B, and the height T_Bcan be substantially equal, thereby forming a cube-shaped body. Further, the diameter d_Bof the lumen can be greater than a diameter of a filament or suture with which thewasher310 is associated, e.g., thesuture limb312a. In other embodiments thesuture limb312acan be threaded through thewasher310 without a preformed lumen. Once the block is associated with thesuture limb312a, the block can increase the surface area of compression of the system or device used in the surgical repair due to the increased surface area of the block.
• A person skilled in the art will recognize that the dimensions of the length L_B, width W_B, thickness or height T_B, and diameter d_Bof thewasher310 can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments, thewasher310 can have a length L_Bapproximately in the range of about 3 millimeters to about 6 millimeters, a width W_Bin the range of about 3 millimeters to about 6 millimeters, and thickness or height T_Bapproximately in the range of about 1 millimeter to about 3 millimeters. Alternatively, the length L_B, width W_B, and thickness or height T_Bcan all be substantially equal and have a dimension approximately in the range of about 2 millimeters to about 5 millimeters. One benefit to the smaller dimensions of thewasher310 is that a surgeon can load a plurality of thewashers310 onto a single suture limb, as described further below, to allow for precision application of the washers on areas of the damaged tissue where they are required. For example, precision application of the washers can include moving the washers along a length of a suture limb to more precisely direct where force from the suture limb will be distributed across a greater surface area. In view of the present disclosures, it is clear that the thickness or height of thewashers310 can be substantially less than a length of suture limb on which thewashers310 are disposed. Any number ofwashers310 can be disposed on the suture limb, including but not limited to up to 30. In some exemplary embodiments, the number ofwashers310 provided on a single suture limb is approximately in the range of about 2 blocks to about 8 blocks.
• An alternative embodiment of an augmentation construct configured to be effectively used in conjunction with other similarly sized constructs on the same suture limb is illustrated inFIG. 5. As shown, the tissue augmentation construct is atissue augmentation block410 that has a configuration that can be described as a washer, disc, or ring. In the illustrated embodiment, it is a ring or circular-shaped washer. For example, thetissue augmentation washer410 can have a bore orlumen414 extending therethrough from aproximal-most face410pto adistal-most face410d. Thebore414 can be used, for example, to receive thesuture limb412aso that thewasher410 andlimb412acan be associated with each other, or alternatively, thelimb412acan be associated with thewasher410 by threading it through the body of the ring without any preformed hole or bore.
• A person skilled in the art will recognize that the dimensions of the diameter D_W, height H_W, and bore diameter d_Wof thewasher410 can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments, the diameter D_Wcan be approximately in the range of about 3 millimeters to about 6 millimeters, height H_Wcan be approximately in the range of about 1 millimeter to about 3 millimeters, and bore diameter d_Wcan be approximately in the range of about 0.5 millimeters to about 2 millimeters. Similar to thewasher310, in view of the present disclosures, it is clear that the thickness or height of thewasher310 can be substantially less than a length of suture limb on which thewashers410 are disposed. Any number ofwashers410 can be disposed on the suture limb, including but not limited to up to 30. In some exemplary embodiments, the number ofwashers410 provided on a single suture limb is approximately in the range of about 2 washers to about 8 washers.
• One benefit of thewashers310,410 is that a surgeon can pass both anterior and posterior sutures through thewashers310,410, as described further below, at the suture insertion point to prevent cheese wiring at the suture insertion point by the sutures. Further, thewashers310,410, can be used in conjunction with any of the tissue augmentation constructs disclosed, including by disposing one ormore washers310,410 onto the same suture limb on which another tissue augmentation construct is already, or will be, disposed.
• A number of techniques known to those skilled in the art can be used to associate thewashers310,410 with therespective suture limbs312a,412a. Thesuture limb312a,412acan be threaded or passed from theproximal-most end310p,410pto thedistal-most end310d,410dof thewashers310 or410 without passing into and/or through the body of thewashers310, or410, i.e., thesuture limb312a,412aextends directly through thelumen314,414. Thus, like thetube110, thewashers310,410 can freely pass along a length of thesuture limb312a,412aunhindered or unrestricted since they are not coupled or attached to thesuture limb312a,412a. In other embodiments, thelimb312a,412acan pass through the body once or more to further secure a location of thewashers310410 with respect to thelimb312a,412a. A person skilled in the art will recognize a variety of other ways by which thewashers310,410 can be associated with thelimbs312a,412awithout departing from the spirit of the present disclosure. For example, thewashers310 or410 can be threaded by hand on to thesuture limb312a,412aeither at the surgical site, or outside of the body. Alternatively, one ormore washers310 or410 can have a threader (not shown) inserted through therespective bores314,414 prior to thewashers310 or410 being threaded onto thesuture limb312a,412a. The threader can be the same or similar to thethreaders206,206′ described above and can be used to thread asuture limb312a,412athrough thewasher310 or410 at a surgical site.
• Similar to augmentation blocks10,110, by including either, or both of, thewashers310 or410 on a suture limb, force applied to the tissue by the suture limb is distributed over a larger amount of surface area. The larger amount is dependent on the surface area of theaugmentation washer310 or410, as well as the number of washers used.
• Materials for Forming Augmentation Constructs
• The constructs discussed above, e.g., theblocks10,110,3010,3110,310, and410, as well as those provided for further below (including various patches or scaffolds) can be made of one or more biocompatible, bioresorbable materials so that after implantation into a patient to replace or repair connective tissue, the strip gradually degrades or remodels over time. The resorption profile of the constructs can be sufficiently long to reinforce and provide structure to tissue during the regeneration or healing process. A person skilled in the art can determine a suitable resorption profile, depending, at least in part, on the desired use of the construct, and can tailor the resorption profile by varying the materials used to form the construct.
• While many different materials can be used to form the tissue augmentation constructs, either alone or in combination with other materials, in some instances the material is a biocompatible polymer. Exemplary embodiments of suitable biocompatible materials synthetic polymers, natural polymers, and combinations of the two. As used herein, the term “synthetic polymer” refers to polymers that are not found in nature, even if the polymers are made from naturally occurring biomaterials. As used herein, the term “natural polymer” refers to polymers that are naturally occurring. In embodiments where the tissue augmentation constructs includes at least one synthetic polymer, suitable biocompatible synthetic polymers can include polymers selected from the group that includes aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylene oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, polyurethanes, poly(ether urethanes), poly(ester urethanes), poly(propylene fumarate), poly(hydroxyalkanoate), polydioxanone, poly-hydroxybutyrate-co-hydroxyvalerate, polyamniocarbonate, polytrimethylene, polyoxaamides, elastomeric copolymers, and combinations or blends thereof. Suitable synthetic polymers for use in the tissue augmentation constructs can also include biosynthetic polymers based on sequences found in collagen, a collagen scaffold, pulverized collagen pieces, elastin, thrombin, silk, keratin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides, and combinations or blends thereof. The types of materials that can be used to construct tissue augmentation constructs, either wholly or in part, include non-absorbable polymers selected from the group that includes, but is not limited to, polyethylene, polypropylene, polyetheretherketone (PEEK), polytetrafluoroethylene, silicone, rubber, or other biocompatible non-absorbable polymers, and combinations thereof. Natural polymers for the use inaugmentation strip10 can be selected from the group that includes but is not limited to a fibrin-based material, collagen-based material, a hyaluronic acid-based material, a cellulose-based material, a silk-based material, a gelatin-based material, a glycoprotein-based material, a cellulose-based material, a polysaccharide-based material, a protein-based material, a fibronectin-based material, a chitin-based material, a pectin-based material, an elastin-based material, an alginate based material, a dextran-based material, an albumin-based material, a natural poly(amino acids) based material, a decellularized tissue, purified extracellular matrix (ECM), a demineralized bone matrix, and combinations thereof.
• Still further, virtually any type of tissue can be used to form the tissue augmentation constructs, including but not limited to autograft tissue and allograft tissue, as well as human allogeneic tissue and xenogeneic tissue, which includes porcine, bovine, and equine among others. The tissue used can be selected from biological connective tissues that include ligament tissue, tendon tissue, a modeled tendon, skin tissue, muscle tissue, periosteal tissue, pericardial tissue, synovial tissue, dermal tissue, an acellular porcine dermal matrix, an acellular bovine dermal matrix, fascia, small intestine tissue, embryonic tissue, amniotic tissue, placental tissue, periodontal tissue, peritoneum tissue, vascular tissue, blood, and combinations thereof. The materials used to form the tissue augmentation constructs can be cross-linked and non-crosslinked, and any material provided for herein can be used in conjunction with other materials, whether synthetic, natural, or a combination thereof. Still further, the tissue augmentation constructs, and/or materials used to form the tissue augmentation constructs, can be treated with platelet-rich plasma (PRP), bone marrow, cells, and other bone and/or tissue growth-promoting materials.
• The material used to form the tissue augmentation constructs can be made and/or formed, using a variety of techniques. These techniques include, but are not limited to, knitting them and weaving them. The overall construction of the materials can be described as being woven, knitted, non-woven, and/or a foam, among other constructions resulting from techniques known to a person skilled in the art. Further, a combination of techniques can be used for a single construct, and/or a portion thereof. The formation techniques can be used with materials, e.g., synthetic polymers and other materials provided for above, as well as tissue.
• Tissue Augmentation Kits
• The filaments and tissue augmentation constructs provided for herein can be included together as part of a soft tissue repair kit. Such a kit can also include components such as a threader, installation tool, bone anchors, and/or a bone drill. For example, one exemplary embodiment of a kit can include one or more tissue augmentation constructs and one or more threaders. In some instances, the tissue augmentation constructs can be pre-disposed on the threaders. The tissue augmentation constructs can include any of the constructs provided for herein or otherwise derivable from the present disclosures, including but not limited to the tissue augmentation blocks10,110,3010,3110,310,410 and thetissue augmentation patches2210,2310,2410, and2510, which are described below. The threaders can include thethreaders206,206′, as well as other threaders known to those skilled in the art or otherwise derivable from the present disclosures. In instances where tissue augmentation constructs are pre-disposed on the threader, the constructs can be disposed on theintermediate portion208,208′ of thethreaders206,206′.
• The kit can also include other components used in conjunction with tissue augmentation constructs and threaders, including but not limited to one or more sutures, such as thesutures12a,112a, one or more installation tools, such as theinstallation tool200′, one or more implants, e.g., bone anchors, and one or more bone drills. In some exemplary embodiments the kit can include atissue augmentation block10,110,3010,3110,310,410 for everysuture limb12a,112a,312a,412athat will be anchored over the soft tissue. The types and configurations of the filaments, constructs, installation tools (which can include threaders as stand-alone installation tools), and bone anchors can be varied, thus providing the user options for use in any surgical procedure. Accordingly, any combination of blocks having a strip or tape configuration (e.g., strip10), a cannulated tube configuration (e.g., tube110), a cannulated bar configuration (e.g.,bar3010, bar3110), and a washer configuration (e.g.,washer310, washer410), can be mixed and matched by a surgeon, as desired, including by disposing them on the same suture limb. The selection of constructs to be used can depend, at least in part on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed.
• The threader and/or installation tool can be a single device used to associate tissue augmentation constructs to limbs multiple times, or multiple threaders and tools can be provided to allow multiple strip-limb combinations to be formed or to allow for different configurations preferred by different users. The threader and/or installation tool can be specifically adapted to be used with particular tissue augmentation constructs, procedures, and/or surgeon's preferences without departing from the spirit of the present disclosure.
• To the extent implants such as anchors are provided as part of a kit, or used in conjunction with any of the disclosures provided for herein, the implants can be any type of implant known to those skilled in the art that are used for various types of tissue repair procedures. For bone anchors, the anchors can be of a hard construction or a soft construction, and in some instances they can be knotless anchors, meaning filaments associated therewith do not need to have knots tied by the surgeon during the surgical procedure to couple the tissue to the filament and/or the anchor. Some exemplary embodiments of hard suture anchors for use in the kits or more generally with the present disclosures include Healix Ti™ anchors that are commercially available from DePuy Synthes, as well as Healix Advance™ anchors, Helix Advance Knotless™ anchors, Healix BR™ anchors, Healix PEEK™ anchors, Healix Transtend™ anchors, Bioknotless® anchors, Gryphon® anchors, Fastin® anchors, Versalok® anchors, Microfix® anchors, Minilok™ anchors, MicroQuickanchors® anchors, and Tacit® anchors, each of which is also commercially available from DePuy Mitek, Inc. Some exemplary embodiments of soft suture anchors for use in the kits or more generally with the present disclosures include those described in U.S. Pat. No. 9,345,567 of Sengun, the content of which is incorporated by reference herein in its entirety.
• To the extent the kit includes a bone drill, any type of bone drill known by those having skill in the art for forming bone holes in which anchors can be disposed can be provided.
• Methods of Use—Rotator Cuff Repairs
• Exemplary methods for using systems, devices, and kits of the type described herein are now described in greater detail. While the methods described herein generally relate to attaching soft tissue to bone, and in this section of the disclosure are primarily discussed with respect to rotator cuff repairs, a person skilled in the art will recognize other types of procedures and repairs with which the constructs and the methods related to the same can be used. Further, to the extent a particular type of tissue augmentation construct is illustrated in the following embodiments, a person skilled in the art would understand how to employ other tissue augmentation constructs provided for herein without departing from the spirit of the present disclosures. Likewise, any sutures or anchors provided for herein or otherwise known to those having skill in the art can be used, including knotless anchors. Still further, while in the illustrated embodiments the lengths of sutures and limbs may be approximately equal, any suture or limb can be any desired length, and thus lengths of sutures and limbs do not need to be equal. Likewise, to the extent the techniques described below discuss having a certain number of suture limbs (e.g., one, two, three, etc.) extending from or otherwise associated with a suture anchor to perform the tissue repair, a person skilled in the art, in view of the present disclosures, will understand how a different number of limbs can be used to perform the same, or a similar type, of repair. A benefit that results from each of the methods described herein is that the tissue augmentation constructs can be associated with the suture being used in the repair in an on-demand manner, thus allowing a surgeon to quickly and easily associate one or more tissue augmentation constructs with the repair suture(s) to form desired footprints for the repair.
• Rotator Cuff Repairs—Double Row Applications
• A first exemplary method of soft tissue repair using tissue augmentation blocks110, illustrated asblocks110a,110b, in conjunction with a double row application or repair is shown inFIGS. 6A-6C. The method involves fixing a piece ofsoft tissue130, e.g., rotator cuff, with respect tobone150. If the tissue augmentation blocks110a,110bare dried, the tissue augmentation blocks110a,110bcan require rehydrating ahead of the procedure. An incision can be made to perform the procedure using any one of a traditional open repair, an arthroscopic repair, or a mini-open repair. Once the surgeon has access to the surgical site and the tissue and bone have been prepared according to accepted surgical techniques, the surgeon can use amedial row stitch140 to install thesuture112 in thesoft tissue130. Alternatively, any known stitch can be used. As shown inFIGS. 6A-6C, themedial row stitch140 results in twosuture limbs112a,112bextending outwardly from the soft tissue.
• As shown inFIG. 6B, the tissue augmentation blocks110a,110bare disposed onsuture limbs112a,112b, respectively. The tissue augmentation blocks110a,110bcan be threaded onto thesuture limbs112a,112bby hand, with aninstallation tool200′ (not shown), and/or with athreader206,206′. As discussed above with reference toFIG. 3, if theinstallation tool200′ is used, asuture limb112acan be passed through the opening, or cinch loop,212, then thehandle portion208 can be pulled to pull thethreader206 and suture limb through the tissue augmentation block110a. Likewise, if just athreader206,206′ is used, a force can be applied to the threader to draw thesuture limb112ainto and through the tissue augmentation block. Once thesuture limb112ahas been threaded in the tissue augmentation block110a, thethreader206 can be removed, and, if theinstallation tool200′ was used, the tissue augmentation block110areleased from theinstallation tool200′. The tissue augmentation blocks110a,110bcan be threaded onto thesuture limbs112a,112bat the surgical site inside of the body. Alternatively, the tissue augmentation blocks110a,110bcan be threaded outside of the body.
• Once theblocks110a,110bhave been threaded onto thesuture limbs112a,112b, they can be advanced in the direction D₁along therespective suture limbs112a,112b. In the illustrated embodiment, theblocks110a.110bare disposed proximate to themedial stitch140 because the length of theblocks110a,110bis similar to the length of the distance extending between themedial stitch140 and the end of thetissue130. However, in embodiments in which the length of theblocks110a,110bis less than that distance, theblocks110a,110bmay not necessarily be proximate to themedial stitch140, but can extend along some portion of the length of thelimbs112a,112bextending between themedial stitch140 and the end of thetissue130. After theblocks110a,110bhave been installed on therespective suture limbs112a,112b, the free ends of thesuture limb112a,112bcan be secured within the body. For example, the free ends of eachsuture limb112a,112bcan be coupled torespective anchors160a,160b, as shown inFIG. 6C, which in some exemplary embodiments can be knotless anchors. Thesuture limbs112a,112bcan then be tightened to secure thesoft tissue130 to thebone150 before theanchors160a,160bare fully fixed in thebone150, thus completing the double row lateral fixation associated with themedial stitch140.
• This procedure can be repeated as many times as required to satisfactorily fixate thesoft tissue130 to thebone150. Theblocks110a,110bprovide a greater footprint for thelimbs112a,1112b, and they may provide a greater surface area to distribute the loading forces of thesuture limbs112a,112bonto thesoft tissue130. While the patient is healing from the procedure, new bands of tendon like tissue can form around thesuture limbs112a,112band into and around theblocks110a,110bto result in a more robust tissue formation in the soft tissue and between the soft tissue and bone. For example, blocks made from collagen scaffold or acellular dermal matrix material can be capable of remodeling while the patient is healing from the procedure into tendon like tissue and integrate with the native tissue. The additional coverage of tendon like tissue across the soft tissue can increase the strength of the tissue-to-bone connection and may prevent further injury.
• Another exemplary soft tissue repair method is provided for inFIGS. 7A-7D. As shown,soft tissue1030 is fixated tobone1050 using an alternative double row application. Once the surgeon has access to the surgical site and the tissue, bone, and blocks1010a-1010chave been prepared according to accepted surgical techniques, including those provided for herein, the surgeon can use medial row stitches1040,1042 to install sutures1012,1016 respectively, in thetissue1030. The blocks1010a-1010ccan be similar to theblocks110,3010,3110, or similar to other blocks and constructs as provided for in the present disclosure. Further, any known stitch can be used. Themedial row stitch1040 results in twosuture limbs1012a,1012bextending outwardly from the soft tissue, and the secondmedial row stitch1042 results in twosuture limbs1016a,1016bextending outwardly from the soft tissue.
• As shown inFIG. 7A, the blocks1010a-1010care threaded ontosuture limbs1012a,1012b,1016b, respectively, using techniques provided for throughout the present disclosure. For example, as illustrated inFIG. 7A, theblock1010ais threaded ontosuture limb1012awith thethreader206. Once theblock1010ahas been threaded onto thesuture limb1012a, as shown inFIG. 7B, it can be advanced in the direction D₁′ along thesuture limb1012auntil it is proximate themedial stitch1040 since the length of theblock1010ais similar to the distance extending between themedial stitch1040 and the end of thetissue1030. Similarly, blocks1010b,1010ccan be advanced along thesuture limbs1012b,1016buntil they are proximate themedial stitches1040,1042, respectively. Theblock1010acan be advanced along the suture limbs with an instrument like aknot pusher1080 or other instrument suitable for advancing the strip along the limb.
• Once theblocks1010b,1010chave been installed on therespective suture limbs1012b,1016b, as shown inFIG. 7C, the free ends ofsuture limbs1012b,1016bcan be secured within the body, for instance by attaching them to theanchor1060bin a lateral row fixation. Similarly, once theblock1010ahas been installed on thesuture limbs1012a, the free ends of thesuture limbs1012a,1016acan be secured within the body, for instance, by attaching them to anchor1060ain a lateral row fixation. As shown inFIG. 7C, thesuture limbs1012b,1016bare installed into theanchor1060bbefore thesuture limbs1012a,1016aare installed into theanchor1060a, such thatsuture limb1016arests atop theblock1010b. Alternatively,suture limb1016acan be placed undersuture limb1012bby changing the order of fixation. Thesuture limbs1012a,1012b,1016a,1016b, can be tightened to secure thesoft tissue1030 to thebone1050 before theanchors1060a,1060bare fully fixed in thebone1050, as shown inFIG. 7D.
• An alternative exemplary method of soft tissue repair is illustrated inFIGS. 8A and 8B. The method fixatessoft tissue1030′ tobone1050′ with an alternative double row application using thewashers310, as shownwashers310a,310b, and310c, in place ofblocks10,110. The alternative double row application disclosed with respect toFIGS. 8A and 8B helps reduce added bulk that can occur when two constructs are stacked on top of each other when suture limbs cross each other as part of the repair design. Further, the use of washers in such formations helps reduce the possibility of any bunching that may occur when using constructs that are of a block configuration. Once the surgeon has access to the surgical site and the tissue, bone, andwashers310a-310chave been prepared according to accepted surgical techniques, including those provided for herein, the surgeon can use an initial mattress stitch to install sutures1012′,1016′ in thetissue1030′. Alternatively, any known stitch can be used. Amedial row stitch1040′ in thetissue1030′ results in twosuture limbs1012a′,1012b′ extending outwardly from the tissue, and secondmedial row stitch1042′ results in twosuture limbs1016a′,1016b′ extending outwardly from the tissue.
• While the following discussion is made only to suturelimb1012a′, for the sake of clarity,suture limbs1012b′,1016a′,1016b′, can havewashers310 threaded thereon in substantially the same manner.Washers310a-310care threaded ontosuture limb1012a′, as illustrated inFIG. 8A. Alternatively, any number ofwashers310 can be used on any of thesuture limbs1012a′,1012b′,1016a′,1016b′. Thewashers310a-310ccan be threaded onto thesuture limb1012a′ by hand, with an installation tool, and/or with a threader using techniques provided for throughout the present application. Oncewashers310a-310chave been threaded onto thesuture limb1012a′ they can be advanced along thesuture limb1012a′. In the illustratedembodiment washers310a-310care disposed such that they are equally spread out over thetissue1030′ along the length oflimb1012a′. After thewashers310 have been installed on therespective suture limbs1012a′,1012b′,1016a′,1016b′, as shown inFIG. 8A, the free ends of thesuture limbs1012a′,1016a′ and1012b′,1016b′ can be secured within the body, for instance, by attaching them toanchors1060a′ and1060b′, respectively. In the illustrated embodiment thesuture limbs1012b′,1016b′ are coupled to theanchor1060b′ before thesuture limbs1012a′,1016a′ are coupled intoanchor1060a′, thus causing thesuture limb1016a′ to rest atop thesuture limb1012b′, although other configurations are possible without departing from the spirit of the present disclosure. Thesuture limbs1012a′,1012b′,1016a′,1016b′ can be tightened to secure thesoft tissue1030′ to thebone1050′ before theanchors1060a′,1060b′ are fully fixed in thebone1050′.
• A further exemplary double row fixation method is illustrated inFIG. 8B. The method for fixingsoft tissue1030″ tobone1050″ is substantially the same as the method illustrated inFIG. 8A but it further includes the use of thecircular washers410, as shownwashers410aand410b, at a location of the medial stitch (not visible). The placement of thewashers410a,410bas shown provides protection of the stitches disposed beneath thewashers410a,410b, while also increasing the footprint of thesuture limbs1012a″,1012b″,1016a″,1016b″ and allowing for the distribution of forces across a surface of thewashers410a,410bthat would otherwise be applied directly to thetissue1030″. In use, thewashers410a,410bcan be threaded onto therespective suture limbs1012a″,1012b″,1016a″,1016b″ before thewashers310′ are threaded onto thesuture limbs1012a″,1012b″,1016a″,1016b″. The double row fixation method can then be completed, for example, according to the process described above with regards toFIG. 8A. With respect to both the configurations illustrated inFIGS. 8A and 8B, the greater an angle formed by the sutures extending from theanchors1060a′,1060b′ and thewashers410a,410b, the greater the stability of the repair.
• A still further alternative method for securingsoft tissue1030′″ tobone1050′″ using a double row fixation technique is illustrated inFIG. 9. Once the surgeon has accessed the surgical site and the tissue, bone, and blocks1010a′″-d′″ have been prepared according to the accepted surgical techniques, including those provided for herein, the surgeon can use initial mattress stitches1040′″,1042′″ to installsutures1012a′″-c′″ and1016a′″-c′″, respectively, in thetissue1030′″. A firstmedial row anchor1060a′″ can be inserted into thebone1050′″ having threesuture limbs1012a′″-c′″ extending therefrom, the threesuture limbs1012a′″-c′″ being threaded through thetissue1030′″ with a firstmedial row stitch1040′″. A secondmedial row anchor1060b′″ can be inserted into thebone1050′″ having threesuture limbs1016a′″-c′″ extending therefrom, the threesuture limbs1016a′″-c′″ being threaded through thetissue1030′″ with a secondmedial row stitch1042′″.
• As illustrated, block1010a′″, which can be in the form of a strip, tube, or cannulated block, among other disclosed configurations, is threaded onto one of thesuture limbs1012a′″,1016a′″ using techniques provided for throughout this disclosure, andsuture limbs1012a′″ and1016a′″ are tied together with a knot to secure thetissue1030′″ to thebone1050′″. Furthermore, once the knot has been formed, theblock1010a′″ can be moved to cover the knot to reduce the possibility of tissue being damaged by the knot.Blocks1010b′″,1010c′″ can then threaded ontosuture limbs1012b′″,1012c′″, respectively, using techniques provided for throughout this disclosure, and advanced to a location proximate themedial stitch1040′″. Similarly, once blocks1010d′″,1010e′″ have been threaded onto thesuture limbs1016b′″,1016c′″, they can be advanced to a location proximate themedial stitch1042′″. After theblocks1010b′″,1010d′″ and1010c′″,1010e′″ have been installed on therespective suture limbs1012b′″,1016b′″ and1012c′″,1016c′″, the free ends of thesuture limbs1012b′″,1016b′″ and1012c′″,1016c′″ can be secured within the body. For example, the free ends of eachsuture limb1012b′″,1016c′″ and1012c′″,1016b′″ can be coupled to therespective anchor1062a′″ and1062b′″. Thesuture limbs1012b′″,1012c′″,1016b′″,1016c′″, can be tightened to secure thesoft tissue1030′″ to thebone1050′″ before theanchors1062a′″,1062b′″ are fully fixed in thebone1050′″.
• A further alternative double row fixation method of soft tissue repair is illustrated inFIGS. 10A-10E using the tissue augmentation construct2810aofFIG. 2G, along with an identically configured tissue augmentation construct2810b(as shown inFIG. 10E). The two constructs do not need to be identically configured, as they could be similarly configured and/or can have other configurations provided for herein or otherwise known to those skilled in the art. The method can fixatesoft tissue2830 tobone2850 with an alternative extra-long block application to provide for additional coverage of the repair.
• Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation blocks have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can insert afirst anchor2860abelow thesoft tissue2830. Thefirst anchor2860acan have twosuture limbs2812a,2812bextending therefrom. The twosuture limbs2812a,2812bcan be passed through thesoft tissue2830 to begin to assist in fixating thesoft tissue2830 to thebone2850. Afirst mattress stitch2840acan be made in thesoft tissue2030 medial to thefirst anchor2860a. Thefirst mattress stitch2840acan result in twosuture limbs2814a,2814bextending out of thesoft tissue2830.
• Theblock2810acan be threaded ontosuture limbs2812a,2814ausing techniques provided for throughout the present disclosure. For example, thesuture limb2814acan be associated with theproximal end2811pof thefirst block2810aby advancing thefirst threader2809ain a first direction D1, as shown inFIG. 10B (thethreader2809ais not illustrated, but in view of the present disclosures, a person skilled in the art will understand how thethreader2809acan be operated to pass thesuture limb2814athrough theproximal end2811pof thefirst block2810a). Further, thesuture limb2812acan be associated with an intermediate2811ianddistal portion2811dof theblock2810aas shown by advancing thesecond threader2809bin a second direction D2, as also shown inFIG. 10B. Although therespective threaders2809a,2809bfor therespective suture limbs2814a,2812aare not illustrated, a person skilled in the art, in view of the present disclosures, will understand how the threaders can be operated to pass the respective suture limbs through portions of thefirst block2810a. Theblock2810acan then be advanced medially such that theproximal end2811pof theblock2810ais proximate thefirst mattress stitch2840a, as shown inFIG. 10C. This process can be repeated for the second block2810band itsrespective limbs2816a,2818b. For example, asecond anchor2862acan be installed below thesoft tissue2830, as shown inFIG. 10E, with theanchor2862bhaving tworepair suture limbs2816a,2816bextending from it. The tworepair limbs2816a,2816bcan be similarly passed through thesoft tissue2830 and asecond mattress stitch2840b(illustrated inFIG. 10E) can be made in thesoft tissue2030, medial to thesecond anchor2862a. Thesecond mattress stitch2840bcan result in twosuture limbs2818a,2818bextending out of thesoft tissue2830. The resultingsuture limbs2816a,2816b,2818a,2818bcan be associated with block2810bto continue the tissue fixation repair.
• After theblocks2810a,2810bhave been installed on therespective suture limbs2812a,2814aand2816a,2818a, the free ends of thesuture limbs2812a,2812b,2816a,2816bcan be secured within the body. For example, the free ends of eachsuture limb2812a,2816band2812b,2816acan be coupled to therespective anchor2860band2862b, as shown inFIGS. 10C and 10E. In the illustrated embodiment,suture limb2812bandsuture limb2816bcan be passed over thesoft tissue2830 to form an “X” configuration or shape such thatsuture limb2812bis secured in thesame anchor2862bassuture limb2816aandsuture limb2816bis secured in thesame anchor2860bassuture limb2812a.Suture limbs2812a,2816acan be disposed through the respectivecentral lumens2870a,2870bof theblocks2810a,2810bto increase the footprint of thesuture limbs2812a,2816a, subsequently decreasing the likelihood of damaging thesoft tissue2830 as discussed above. Because theblocks2810a,2810bhave a sufficient length, they can be installed so that they extend medially over first andsecond repairs2838a,2838b, as shown inFIG. 10E. Thesuture limbs2812a,2812b,2816a,2816bcan then be tightened to secure thesoft tissue2830 to thebone2850 before theanchors2860b,2862bare fully fixed in thebone2850. The twolimbs2814a,2814bcan be tied together with aknot2880a, andlimbs2818a,2818bcan be tied together with aknot2880bto secure the proximal ends2811pof therespective blocks2810a,2810bat a location medial of therepairs2838a,2838b, as shown inFIGS. 10D and 10E. A person skilled in the art will recognize a number of repairs that can be represented by therepairs2838a,2838bin view of the present disclosure and the skilled person's knowledge.
• Rotator Cuff Repairs—Single Row Applications
• Another method of soft tissue repair is illustrated inFIGS. 11A-11C. The method fixatessoft tissue130′ tobone150′ using a single row application. Once the surgeon has access to the surgical site and the tissue, bone, and blocks110a′,110b′ have been prepared according to accepted surgical techniques, including those provided for herein, the surgeon can use an initial mattress stitch to installsuture112′ in thesoft tissue130′. Alternatively, any known stitch can be used. Themattress stitch140′ results in twosuture limbs112a′,112b′ extending outwardly from the soft tissue.
• As shown inFIG. 11B, theblocks110a′,110b′ are threaded on to suturelimbs112a′,112b′, respectively, using techniques provided for throughout the present application. Once theblocks110a′,110b′ have been threaded onto thesuture limbs112a′,112b′, they are advanced in the direction D₁′ along the respective sutures until they are proximate themattress stitch140′. As described above, the location of the strips with respect to thestitch140′ can depend, at least in part, on the size of theblocks110a′,110b′ and the distance between thestitch140′ and the end of thetissue130′. After theblocks110a′,110b′ have been installed on therespective suture limbs112a′,112b′, the free ends of thesuture limbs112a′,112b′ can be secured within the body, for instance, by attaching them to asingle anchor160′, as shown inFIG. 11C. Thesuture limbs112a′,112b′ can be tightened to secure thesoft tissue130′ to thebone150′ before theanchor160′ is fully fixed in thebone150′, thus completing the single row fixation associated with themedial stitch140′. In some exemplary embodiments a second anchor having two suture limbs extending therefrom, each limb having at least one tissue augmentation construct disposed thereon, can be implanted in a similar manner as theanchor160′,limbs112a′,112b′, and blocks110a′,110b′ with respect to thesame tissue130′ andbone150′ to provide a second securement system for the tissue. As with all of the various configurations provided for herein, any number and combination of implants, e.g., bone anchors, sutures, and tissue augmentation constructs can be used to secure soft tissue to bone.
• Alternative single row applications are shown inFIGS. 11D-11F. In a first alternative single row application illustrated inFIG. 11D, a standard single row repair can be completed using twoanchors160a″,160b″ installed in thebone150″ below thetissue130″.Anchors160a″,160b″ can each have twosuture limbs112a″,112b″ and116a″,116b″ extending therefrom, respectively.Suture limbs112a″ and116a″ can be threaded through thesoft tissue130″ and used to bring thesoft tissue130″ into contact with thebone150″.Sutures limbs112b″ and116b″ can similarly be threaded through thesoft tissue130″.
• As shown inFIG. 11D, atissue augmentation block110″ can be threaded on to one of thesuture limbs112b″,116b″ using techniques provided for throughout this disclosure and advanced to a desired location with respect to thetissue130″. After theaugmentation block110″ has been installed on one of the suture limbs, the free end of eachsuture limb112b″,116b″ can then be tied together using a knot, not shown. Furthermore, theblock110″ can be moved into position such that it covers the knot, thereby minimizing any potential tissue abrasion by the knot, and is in contact with thetissue130″.
• A second alternative single row application is illustrated inFIG. 11E. Similar to the procedure ofFIG. 11D, a standard single row repair can be completed using twoanchors160a′″,160b′″ installed inbone150′″ belowtissue130′″. As shown, afirst suture111′″ can be installed medially of the repair with amattress stitch140a′″, such that twosuture limbs111a′″,111b′″ extend from thetissue130′″, and asecond suture113′″ can be installed medially of the repair with asecond mattress stitch140b′″, such that twosuture limbs113a′″,113b′″ extend from thetissue130′″. In some instances, after the two mattress stitches140a′″,140b′″ have been installed in thetissue130′″, anchors160a′″,160b′″ can be installed into thebone150′″ below thetissue130′″.Operative sutures112′″,114′″ can be used to couple thetissue130′″ to theanchors160a′″,160b′″ respectively attached thereto according to accepted surgical practice.
• Tissue augmentation blocks110a′″-d′″ can be threaded on to thesuture limbs111a′″,111b′″,113a′″,113b′″ using techniques provided for throughout this disclosure and can be advanced along the respective sutures to desired locations. The free ends of thesuture limbs111a′″,113a′″ and111b′″,113b′″ can be tied to, and tightened about,operative sutures112′″,114′″ respectively.
• FIG. 11F illustrates a further alternative single row application. Afirst suture111″″ can be installed medially with amattress stitch140a″″ such that twosuture limbs111a″″,111b″″ extend from thetissue130″″, and asecond suture113″″ can be installed with asecond mattress stitch140b″″ such that twosuture limbs113a″″,113b″″ extend from thetissue130″″. After the first andsecond sutures111″″,113″″ have been installed, first and secondmedial anchors160a″″,160b″″ are installed in thebone150″″, below thetissue130″″.Operative sutures112″″,114″″ coupled toanchors160a″″,160b″″, respectively, can be used to perform the repair such that thetissue130″″ is brought into contact with thebone150″″, according to accepted surgical practices. Once thetissue130″″ has been repaired, blocks110a″″-d″″ can be installed ontosuture limbs111a″″,111b″″,113a″″,113b″″ using techniques provided for throughout this disclosure. Free ends of thesuture limbs111a″″,113a″″ and111b″″,113b″″ can be secured within the body, for instance, by attaching them toanchors160c″″ and160d″″, respectively. Thesuture limbs111a″″,111b″″,113a″″,113b″″ can be tightened to further secure theblocks110a″″-d″″ to thesoft tissue130″″ such that the repairs made with thesutures112″″,114″″ are covered by tissue augmentation blocks.
• A further exemplary method of soft tissue repair is illustrated inFIG. 12. The method fixates a piece ofsoft tissue1130, e.g., rotator cuff, tobone1150 using a single row fixation. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation block have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can use amattress row stitch1140 to install sutures1112,1114 andmattress row stitch1142 to install sutures1116,1118 in thesoft tissue1130. Sutures1112,1114 and1116,1118 are installed intoanchors1160a,1160b, respectively, below thetissue1130 in thebone1150. As shown inFIG. 12, each of the mattress stitches1140 and1142 results in foursuture limbs1112a,1112b,1114a,1114bandsuture limbs1116a,1116b,1118a,1118bextending outwardly from the soft tissue.
• At least oneblock310′ can be threaded on at least one of the suture limbs of each suture1112,1114,1116,1118.Block310′ can be similar to block310, although one difference between the two is that a thickness of theblock310′ is greater than the thickness ofblock310. Alternatively, block310′ can have any suitable dimension as desired for a given procedure. In some embodiments, each of thesuture limbs1112a,1114a,1116a,1118acan have ablock310′ threaded thereon using techniques provided for throughout the present disclosure, and then the two suture limbs of each pair can be tied together. For example,suture limbs1112a,1112bcan be tied together afterblock310′ has been threaded thereon. After thesuture limbs1112a,1112bhave been tied together, theblock310′ can be moved over the knot to buffer, or cover, the knot. This process can be repeated for each of the suture limb pairs1114aand1114b,1116aand1116b, and1118aand1118b.
• A still further exemplary method of soft tissue repair is illustrated inFIG. 13. The method fixates a piece ofsoft tissue1230, e.g., rotator cuff, tobone1250 using a single row rip-stop stitch. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation constructs have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can use astitch1240 to couple the sutures1212,1214 to anchor1260aand astitch1242 to couple the sutures1216,1218 to anchor1260b. Any known stitch can be used. As shown inFIG. 13, thestitch1240 results in foursuture limbs1212a,1212b,1214a,1214bextending outwardly from the soft tissue, and thestitch1242 also results in foursuture limbs1216a,1216b,1218a,1218bextending outwardly from the soft tissue.
• Atissue augmentation block1210 can be threaded on to one of the suture limbs associated with eachmattress knot1240,1242 using techniques provided for throughout the present disclosure. Theblock1210 in the illustrated embodiment is a construct similar to thebars3010,3110. In the illustrated embodiment, thesuture limbs1212aand1216aeach have theblock1210 associated with it. Once each of thesuture limbs1212a,1216ahas ablock1210 threaded thereon, thesuture limbs1212a,1216acan be tied together with acomplementary suture limb1212b,1216b, respectively. Furthermore, theblock1210 can be slid over the knot to buffer, or cover, the knot, as illustrated. Then thesuture limbs1214a,1214bcan be tied together over the top ofblock1210 to create a rip-stop stitch. Advantageously,suture limbs1214a,1214b, once tied together will be prevented from tearing through thesoft tissue1230 because theblock1210 will act as a buffer thereby distributing the applied load. This process can be repeated for thesecond mattress stitch1242.
• FIG. 14 illustrates a further method of soft tissue repair. The method provides for fixating a piece ofsoft tissue1330, e.g. rotator cuff, tobone1350, using an anterior-posterior mattress stitch extending between anchors. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation block have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can thread twolimbs1312a,1312bof asuture1312 coupled to ananchor1360athroughtissue1330. Similarly, asecond anchor1360bcan be implanted in thebone1350 havingsuture limbs1314a,1314bof asuture1314 extending from theanchor1360bthroughtissue1330. Any known stitch can be used.
• Oneblock1310 can be threaded on to either of thesuture limbs1312a,1314aof eitheranchor1360a,1360busing techniques provided for throughout the present disclosure. The illustratedblock1310 has a length approximately in the range of about 10 millimeters to about 20 millimeters, a width approximately in the range of about 2 millimeters to about 5 millimeters, and a height approximately in the range of about 1 millimeter to about 3 millimeters. Once thesuture limb1312ahas ablock1310 threaded thereon, thesuture limb1312acan be tied together with thesuture limb1314a. Furthermore, after thesuture limbs1312a,1314ahave been tied together, theblock1310 can be slid over the knot, not shown, to buffer, or cover, the knot. Then thesuture limbs1312b,1314bcan be tied together over theblock1310. Advantageously, thesuture limbs1312b,1314b, once tied together, will be prevented from tearing through thesoft tissue1330 because theblock1310 will act as a buffer between them distributing the applied load.
• An alternative single row fixation method of soft tissue repair is illustrated inFIG. 14. The method fixatessoft tissue1430 tobone1450 with an alternative, extra-long and extra-wide block application. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation blocks have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can fixate thesoft tissue1430 to thebone1450 according to accepted surgical techniques to create therepairs1438a,1438b, shown in phantom. Once therepairs1438a,1438bare completed, afirst mattress stitch1440 is made through thesoft tissue1430, medial to thesoft tissue repair1438a, and asecond mattress stitch1442 is made, medial to therepair1438b, to install the sutures1412 and1414 in thesoft tissue1430. Thefirst mattress stitch1440 results in twosuture limbs1412a,1412bextending outwardly from thesoft tissue1430, and thesecond mattress stitch1442 results in twosuture limbs1414a,1414bextending outwardly from the soft tissue. Alternatively, thestitches1440,1442 can be made before therepairs1438a,1438bare performed.
• The blocks1410a-1410chave a configuration that can be considered to be a larger version of some other block configurations provided for herein. As shown, the blocks1410a-1410chave a substantially rectangular shape, like the cannulatedblock configurations3010,3110 ofFIGS. 2E and 2F, but with a more substantial thickness. Other configurations of the blocks1410a-1410c, particularly in view of the present disclosures, are also possible, including but not limited to configurations that are more akin to one or more of the tape strips10, thetubes110, and thewashers310,410, or combinations thereof. In one exemplary embodiment, the blocks1410a-1410ccan have a length approximately in the range of about 15 millimeters to about 25 millimeters, a width approximately in the range of about 4 millimeters to about 5 millimeters, and a thickness approximately in the range of about 1 millimeter to about 3 millimeters.
• Theblocks1410a,1410ccan be threaded ontosuture limbs1412a,1414ausing techniques provided for throughout the present disclosure. In the illustrated embodiment, theblock1410bhas two suture limbs, thesuture limbs1412band1414b, associated with it. While this latter configuration can also be achieved using the techniques provided for throughout the present disclosure, in one exemplary method, a single installation tool can be used to associate bothsuture limbs1412b,1414bwith theblock1410bat the same time. For example, the threader206 (not shown) can be disposed in theblock1410band can have both limbs passed through its distal opening212 (not shown) before operating the threader as described above to associate thelimbs1412b,1414bwith theblock1410b. Alternatively, theblock1410bcan have two threaders disposed therethrough to thread thesuture limbs1412b,1414bindividually therethrough. In a further alternative, a single threader can be threaded through theblock1410bto pull thesuture limb1412bthrough theblock1410b, and then the threader, or a different threader, can be inserted into theblock1410bto thread thesuture limb1414bthrough theblock1410b.
• Once the blocks1410a-1410chave been threaded onto thesuture limbs1412a,1412b,1414a,1414bthey can be advanced along thesuture limbs1412a,1412b,1414a,1414b, respectively, until they are proximate themedial stitches1040,1042. One advantage of the blocks1410a-1410cis that they can be sized to cover a substantial portion of a surgical site that includes a perimeter defined by theanchors1460a,1460band the mattress stitches1440,1442. Other advantages of tissue augmentation constructs provided for herein are also applicable. After the blocks1410a-1410chave been installed on the respective suture limbs, the free ends of thesuture limbs1412a,1412band1414a,1414bcan secured within the body, for instance, by attaching them toanchors1460aand1460b, respectively. Thesuture limbs1412a,1412b,1414a,1414b, can be tightened to secure thesoft tissue1430 to thebone1450 before theanchors1460a,1460bare fully fixed in thebone1450.
• The various embodiments described above can be used in conjunction with any of the other embodiments described above such that some of the soft tissue is secured with a double-row application and some portions are secured with the single row application. Still further, any number of suture limbs and tissue augmentation blocks can be used during any particular procedure, including disposing multiple strips on a single limb and/or using only a single limb or more than two limbs.
• Rotator Cuff Repairs—Partial Tear Repairs
• An exemplary method of partial tear soft tissue repair is illustrated inFIGS. 16A-16C. The method fixates a piece ofsoft tissue1530, e.g. rotator cuff, tobone1550 in a situation where a partial tear occurs. As shown inFIG. 16A,soft tissue1530 is maintained in contact with thebone1550 at1530d. The length X shows what a “healthy” footprint of contact should be between thetissue1530 andbone1550. This procedure can aid in the reattachment of the soft tissue to the bone to create a “healthy” footprint. Prior art procedures can result in a depression at the attachment point due to the necessary compression of the suture against the tissue, thus causing a weakening of the tissue, and more generally, the rotator cuff.
• Once the surgeon has access to the surgical site and the tissue, bone, and the tissue augmentation construct have been prepared according to accepted surgical techniques, including those provided for herein, the surgeon can install ananchor1560 into thebone1550. Theanchor1560 can have asuture1512 coupled thereto having twosuture tails1512a,1512bextending therefrom that can be passed through thesoft tissue1530. Ablock1510 can be threaded onto at least one of thesuture tails1512a,1512b. Theblock1510 can be any of the configurations provided for herein, including but not limited to theblocks10,110,3010,3110,310, and410 and thepatches2210,2310,2410, and2510, which are described below. Theconstructs1510 can be threaded onto thesuture limb1512a, for example, using techniques provided for throughout the present disclosure, and advanced along thesuture1512auntil it is proximate thetissue1530. After theconstruct1510 has been installed on one of the suture limbs, the free end of eachsuture limb1512a,1512bcan then be tied together using a knot, not shown, to bring the damagedtissue1530 into contact with thebone1550. Theconstruct1510 can then be moved into position such that it covers the knot and is in contact with thetissue1530. As shown inFIG. 16B, theconstruct1510, once installed, can add height to the depression to build back height to the repairedtissue1530.
• Methods of Use—Non-Rotator Cuff Repairs
• The present disclosure contemplates that the tissue augmentation constructs provided for herein have applications outside of rotator cuff repairs as augmentation constructs. Some, non-limiting examples of those alternative procedures are provided for below. These examples are by no means exhaustive. Further, a person having skill in the art will understand how some of the disclosures provided for in this non-rotator cuff repair section can be adapted for use in rotator cuff repair procedures. Each of the embodiments described below, including those discussed after the non-rotator cuff repairs (i.e., labrum repair or augmentation, ACL repair, Achilles repair, AC joint-repair, meniscal repair, and superior capsule reconstruction), are discussed with respect to using a tissue augmentation construct, which includes any of the blocks and patches disclosed herein or otherwise derivable from the present disclosure. A person skilled in the art, in view of the present disclosures, will understand how to adapt various tissue augmentation constructs for use in the various procedures. Further, in exemplary embodiments of each of the methods described in the present disclosure, collagen, for example, can be used as part of, or to form entirely or almost entirely, the construct. This allows the construct to grow in the area of the repair once healed. Other materials can also be used to form the constructs, including others that achieve a similar result as collagen.
• Non-Rotator Cuff Repairs—Labrum Defect Corrections
• One alternative procedure is illustrated inFIGS. 17A-17D. The method uses atissue augmentation construct1610, or constructs, to fill in a gap wheresoft tissue1630 has been damaged and torn from thebone1650. For example, as shown inFIG. 17A, alabrum1630 can have a tear ordefect1635 where a portion of thebone1650 is exposed. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation construct have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can install afirst anchor1660ainto the bone at aproximal location1635pof thetear1635. Thefirst anchor1660ahas asuture1612 installed therein. The tissue augmentation construct1610 can be threaded onto thesuture limb1612 using techniques provided for throughout the present disclosure, and advanced along the suture until thetissue augmentation construct1610 is proximate the proximal end of thetear1635p. Any type of tool provided for herein or otherwise known to those skilled in the art can be used to advance theconstruct1610 towards theanchor1660a, including a knot pushing tool. The tissue augmentation construct1610 can be approximately the same length asdefect1635 once implanted, and can be pre-cut and/or cut at the surgical site in real time to assure proper fit.
• After thetissue augmentation construct1610 has been installed on thesuture limb1612, the free end of thesuture limb1612 can then be anchored down to the bone with asecond anchor1660b, such as a knotless-type fixation anchor. The tail ofsuture1612 can be tightened before theanchor1660bhas been fully inserted into the bone. By locating theanchors1660a,1660band construct1610 in these locations, theconstruct1610 ends up on a back edge of the glenoid rather than on its face and the repair can be used to rebuild the labrum rather than just fix the defect, as was more typical in previous labrum repair procedures. In an alternative embodiment, separate sutures extending from each of the twoanchors1660a,1660bcan be thread through the labrum on either side, the tissue augmentation construct1610 can be disposed on one of the two sutures, the two sutures can be coupled together, e.g., using a knot. Furthermore, the tissue augmentation construct1610 can be disposed over a location at which the two sutures are tied together to protect the location at which the sutures are coupled together.
• Non-Rotator Cuff Repairs—ACL Repairs
• Another alternative procedure is illustrated inFIGS. 18A-18C. The method uses atissue augmentation construct1710, or constructs, to repair a torn ACL. For example, as shown inFIG. 18A, one bundle of theACL1702 is torn, or otherwise damaged. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation construct have been prepared according to accepted surgical techniques, the surgeon can begin the partial ACL repair. First, abone tunnel1704 is drilled through thefemur1706 andtibia1707 next to the native,undamaged ACL1708. Next, atissue augmentation construct1710, which as shown inFIG. 18B hassuture limbs1712a,1712bextending from opposed ends, is prepared in the same manner as described above with regards to other embodiments. Theconstruct1710 can have a length approximately in the range of about 5 millimeters to about 100 millimeters. As shown inFIG. 18C, theconstruct1710 can be threaded into thebone tunnel1704 such that construct1710 is in contact with theundamaged ACL1708. Thesuture limbs1712a,1712bcan be used to fix theconstruct1710 within the bone tunnel according to known surgical techniques.
• Alternatively, theconstruct1710 can be used to augment an autograft implant. In situations where an autograft, or allograft, implant is too short, and/or too thin and not strong enough, to complete the repair, theconstruct1710 can be sutured or otherwise coupled to the autograft implant to create an implant of the required size. In a further alternative, a construct having a lumen extending therethrough can be threaded over an autograft, or allograft, implant to further strengthen an autograft or allograft implant for an ACL repair.
• Non-Rotator Cuff Repairs—Superior Capsule Reconstructions
• Still another alternative procedure is illustrated inFIG. 19. The method can use at least one of tissue augmentation constructs1810a,1810bto assist in anchoring down a superiorcapsule reconstruction graft1820 over ahumeral head1802. Once the surgeon has access to the surgical site and the tissue, bone, tissue augmentation constructs, and superior capsule reconstruction graft have been prepared according to accepted surgical techniques, including those provided for herein, the surgeon can affix one end of thegraft1820 to theglenoid rim1804. The surgeon can affix one end of thegraft1820 to theglenoid rim1804 by installing a firstmedial anchor1860ahaving asuture1812aextending therefrom. A first tissue augmentation construct1810acan be thread onto thesuture1812ausing techniques provided for throughout the present disclosure, and theconstruct1810acan be tightened against thegraft1820 using techniques provided for herein or otherwise known to those skilled in the art, such as for example, by tyingsuture1812ato suture1812b, not shown, both of which extend from theanchor1860a. The pressure of theconstruct1810aon thegraft1820 can hold thegraft1820 at a desired location with respect to theglenoid rim1804. An opposite end of thegraft1820 can be anchored proximate to thehumeral head1802 and a location and/or size of thegraft1820 adjusted so that theglenoid rim1804 is brought into contact with thehumeral head1802 in accordance with techniques used in superior capsule reconstruction procedures.
• While a number of different techniques can be used to couple the other end of thegraft1820 proximate to thehumeral head1802, in the illustrated embodiment first and second lateral anchors1862a,1862bare used in conjunction with a second tissue augmentation construct1810bto make the repair. More particularly, in one exemplary embodiment, at least one of theanchors1862a,1862bcan have asuture1812bassociated therewith and the second tissue augmentation construct1810bcan be disposed on at least a portion of thesuture1812busing techniques provided for in the present disclosure. Thesuture1812bcan extend between the twoanchors1862a,1862b, against using any of the techniques provided for herein or otherwise known to those skilled in the art, and theconstruct1810bcan be tightened down against thegraft1820 to help maintain a location of thegraft1820 with respect to thehumeral head1802 while allowing theconstruct1810bto better distribute any force applied by thesuture1812bacross the surface area of theconstruct1810b. Any number of tissue augmentation constructs can be used in the repair, and in alternative embodiments tissue augmentation constructs may only be used in conjunction with coupling thegraft1820 with only one of theglenoid rim1804 and thehumeral head1802.
• Repairing Soft Tissue by Closing Gaps—Rotator Cuff and Non-Rotator Cuff Examples
• Two exemplary embodiments for closing gaps or voids in tissue are illustrated inFIGS. 20A-F. The first illustrated embodiment, as shown inFIGS. 20A-20C, relates to a rotator cuff margin convergence, and the second, as shown inFIGS. 20D-20F, a hip capsular closure. However, a person skilled in the art will recognize other types of procedures these embodiments can be applied to in practice without departing from the spirit of the present disclosure.
• FIG. 20A showsrotator cuff tissue1930 having a void orgap1905. First andsecond sutures1912a,1912bcan be associated with first andsecond constructs1910a,1910busing techniques provided for throughout the present disclosure. As shown inFIG. 20B, a first free end of thefirst suture1912bcan be threaded into therotator cuff tissue1930 on a first side of thevoid1905 and threaded back through therotator cuff tissue1930 on the opposite side of thevoid1905. The first free end can be tied to the second free end to bringedges1930a,1930bof the void1905 together. This process can be repeated for thesecond suture1912bto complete the repair, as shown inFIG. 20C. The tissue augmentation constructs1912a,1912bcan provide the many benefits provided for herein, including but not limited to increased surface area through which forces from thesutures1912a,1912acan be distributed, protection of a knot used to couple free ends of thesutures1912a,1912b, and providing a scaffold for new tissue to grow to create a stronger repair between theedges1930aand1930b, with the scaffold essentially becoming a new layer of tissue on top of the existingrotator cuff tissue1930.
• FIG. 20D showship capsular tissue1930′ having a void orgap1905′. First andsecond sutures1912a′,1912b′ can be associated with first andsecond constructs1910a′,1910b′ using techniques provided for throughout the present disclosure. As shown inFIG. 20E, a first free end of thefirst suture1912a′ can be threaded into thehip capsular tissue1930′ on a first side of the void1905′ and threaded back through thehip capsular tissue1930′ on the opposite side of the void1905′. The first free end can be tied to the second free end to bringedges1930a′,1930b′ of the void1905′ together. This process can be repeated for thesecond suture1912b′ to complete the repair, as shown inFIG. 20F. As with the tissue augmentation constructs1912a,1912b, the tissue augmentation constructs1912a′,1912b′ can provide the many benefits provided for herein, including the highlighted benefits provided for with respect to theconstructs1912a,1912b.
• Tissue Augmentation Constructs—Collagen Tacks/Buttons
• Another exemplary embodiment of a tissue augmentation construct is illustrated inFIGS. 21A and 21B. The tissue augmentation construct, as shown a tack orbutton2010, has a generally cylindrical shape that is configured to be disposed on or otherwise associated with asuture2012. More particularly, thetissue augmentation tack2010 can have a substantially cylindrical body with a bore orlumen2014 extending therethrough from aproximal-most end2010pto adistal-most end2010d. Thebore2014 can be used, for example, to receive thesuture2012 by means of astitch2013 so that thetack2010 andsuture2012 can be associated with each other, as described in greater detail below. In alternative embodiments, thesuture2012 can be passed through thetack2010 without a pre-defined lumen being formed in a body of thetack2010, and/or thesuture2012 can be wrapped around or otherwise coupled to thetack2010 without passing through it. As shown, thetack2010 has a height H_Tthat is less than a diameter D_T. Further, the diameter D_Tcan be greater than a diameter of a filament or suture with which thetack2010 is associated, e.g., thesuture2012, thereby increasing the footprint of thesuture2012 and the surface area of tissue augmentation of the system or device used in the surgical repair.
• Thesuture2012 can be any type of suture provided for herein or otherwise known to those skilled in the art. In the illustrated embodiment, thesuture2012 includes a self-lockingmechanism2015 associated with anintermediate portion2012iof thesuture2012, acollapsible loop2040 extending from one side of the self-lockingmechanism2015, and fixed andtensioning tails2012fand2012textending from an opposite side of the self-lockingmechanism2015. The self-lockingmechanism2015 can take a variety of forms, and in the illustrated embodiment it has a finger-trap-like configuration formed by passing a first limb of thesuture2012 through a portion of a second limb of thesuture2012 before having the first limb exit the second limb to result in the fixed andtensioning tails2012f,2012t. The fixedtail2012fcan be wrapped around and/or coupled to thetack2010, and as shown astitch2013 is used to help manage the fixedtail2012 and attach it to thetack2010. Thetensioning tail2012tcan be used to help adjust a diameter of thecollapsible loop2040.
• Thecollapsible loop2040 can be coupled to an implant, e.g., abone anchor2060, and a diameter of theloop2040 can be adjusted by moving the self-lockingmechanism2015 proximally away from theanchor2060 and distally towards theanchor2060 as shown in the illustrated embodiment, for instance by applying a force proximally away from theanchor2060 to thetensioning tail2012t. Theanchor2060 can be a low profile anchor so that theanchor2060 can more easily pass through tendon. A person skilled in the art will recognize various suitable low profile anchors that can be used in conjunction with the present disclosure, including some such anchors that are provided for above, e.g., Gryphon® and Healix Transtend™ anchors.
• A number of other suture configurations are possible, including some disclosed further below and others known to those skilled in the art. Some suture configurations that can be incorporated into this design include but are not limited to those disclosures provided for in U.S. Pat. No. 8,821,544, entitled “Surgical Filament Snare Assemblies,” and U.S. Pat. No. 9,060,763, entitled “Systems, Devices, and Methods for Securing Tissue, the content of each which is incorporated by reference herein in their entireties.
• A person skilled in the art will recognize that the dimensions of the height H_Tand diameter D_Tof thetissue augmentation tack2010, as well as a diameter of thebore2014, can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments a ratio of the diameter D_Tof thetack2010 to a diameter of thesuture limb2012 can be approximately in the range of about 2:1 to about 100:1, and more particularly the diameter D_Tcan be at least three times greater than the diameter of the filament or suture with which thetissue augmentation tack2010 is associated in some instances. A variety of other sizes and shapes of thetissue augmentation tack2010, including ratios of the dimensions of the tack and associated components (e.g., the suture2012) can be utilized without departing from the spirit of the present disclosure.
• While ratios can be useful to help describe the relationship between thetack2010 and thefilament2012, and the relationship between the dimensions of thetack2010, some exemplary, non-limiting dimensions for a tissue augmentation tack can also be useful in understanding the present disclosure. As mentioned above, these dimensions can be dependent on a variety of factors. In some embodiments, the height H_Tcan be approximately in the range of about 1 millimeter to about 1 centimeter, and the diameter D_Tcan be approximately in the range of about 1 millimeter to about 10 millimeters. The size of the diameter d of thebore2014 can also depend on a variety of factors, including but not limited to the size of the limb to be passed therethrough. In some embodiments, the diameter d can be approximately in the range of about 0.5 millimeters to about 3 millimeters. Alternatively, bore2014 may not be present and thefilament2012 can be passed through thetack2010 without a bore. Thetack2010 can be made from any of the materials provided for above with respect to the other tissue augmentation constructs, including but not limited to collagen.
• In some embodiments, as shown inFIG. 21B, aninserter tool2070 can be used to install theanchor2060 in a trans-tendon approach into a preformed bone bore in abone2050. Theinserter tool2070 can have a releasable mechanism (not shown) at adistal end2070dthat can releasably engage theanchor2060 such that after installation of the anchor intobone2050, the inserter tool can be removed. For example, the releasable mechanism can be a compression fit, a thread to engage theanchor2060, a ball detent, or other releasable mechanisms that can be associated with theinserter tool2070 in view of the present disclosures or otherwise known by those skilled in the art.
• In use, theinserter tool2070 can be used to insert theanchor2060 through the tendon, or other soft tissue,2030, as shown inFIG. 21C. The surgeon can then remove theinserter tool2070 from theanchor2060, after it has been secured into thebone2050 below thetendon2030, as shown inFIG. 21D. Once theanchor2060 is secure in thebone2050, tension can be applied to the tensioning tail in the direction T₁, as shown inFIG. 21E. As thetensioning tail2012tis pulled, the diameter of thesuture loop2040 is reduced and thetack2010 is brought into contact to thetendon2030 to compress thetendon2030 against thebone2050. The self-lockingmechanism2015 maintains a location of thetensioning tail2012tto keep the construct in a locked configuration. The tensioning tail can then be trimmed.
• Numerous advantages result from the use of thetissue augmentation tack2010. As illustrated inFIG. 21E, the resulting configuration is one in which thetack2010 is disposed on top of thetissue2030, and there are no hard components and/or knots exposed. This decreases the possibility of tissue abrasion, among other benefits. The same types of benefits provided for with other constructs provided for herein are also equally applicable. For example, when thetissue augmentation tack2010 is made of collagen or other types of tissue-growth-promoting materials, the repair can result in a tissue remodel such that no component but the suture remains. Further, after thetack2010 is advanced towards theanchor2060 and secured at thetissue2030, no suture management is really required post-procedure.
• Alternatively, if twotensioning tacks2010a,2010bare used, as shown inFIG. 21F, the tensioning tacks2010a,2010bcan be installed in the same manner as described above with regards toFIGS. 21A-21E. Instead of trimming thetails2012t_1,2012t_2, thetensioning tails2012t_1,2012t_2 can be secured into alateral row anchor2062 to provide further compression of thetissue2030 against thebone2050. In a further alternative method, as shown inFIG. 21G, the two tensioningtails2012t_1′ and2012t_2′ can be tied together with aknot2018. Theknot2018 can be covered by one or more additional tissue augmentation constructs as provided for herein.
• Other non-limiting alternative embodiments of thetack2010 are illustrated inFIGS. 21H and 21I astacks2010′ and2010″, respectively, the alternatives focusing on other types of self-locking mechanisms associated with the respective sutures,2012′,2012″. The configuration of thesuture2012′ includes a self-locking slidingknot2015′ configured to selectively restrict the movement of thetensioning tail2012t′ relative to thetack2010′. A person skilled in the art will recognize many different types of self-lockingknots2015′ that can be used in conjunction with thetack2010′.
• A furtheralternative tack2010″ is shown inFIG. 21I. Thetack2010″ has substantially the same dimensions as thetack2010, and can be made of substantially the same materials. Thetissue augmentation tack2010″, however, has twobores2014a″,2014b″ extending from a proximalmost surface2010p″ to adistal-most surface2010d″. The twobores2014a″,2014b″ can be parallel to one another, as shown inFIG. 21I, however other alternative configurations are contemplated. In some embodiments, no bores may exist and instead suture can be passed through or otherwise associated with thetack2010″ as provided for herein or otherwise known to those skilled in the art.
• Thesuture2012″ used in conjunction with thetack2010″ can be similar to thesuture2012, but as shown it is manipulated into a configuration having two self-lockingmechanisms2015a″ and2015b″ and twoloops2040a″ and2040b″. The self-lockingmechanisms2015a″ and2015b″ can be formed as described above or as otherwise known to those skilled in the art. In the illustrated embodiment, the self-lockingmechanisms2015a″ and2015b″ have a finger-trap-like configuration formed by passing a first limb of thesuture2012″ through a portion of a second limb of thesuture2012″ before having the first limb exit the second limb to result in fixed andtensioning tails2012f_1″,2012f_2″ and2012t_1″ and2012t_2″. As shown, the fixedtails2012f_1″ and2012f_2″ can be coupled to thetack2010″ using one ormore stitches2013″, and tensioningtails2012t_1″ and2012t_2″ can extend from the proximal-most end20120p″ of thetack2010″. Theloops2040a″ and2040b″ can both be coupled to a suture implant, as shown ananchor2060a″, and as described above, thetensioning tails2012t_1″ and2012t_2″ can be operable to adjust a diameter of therespective loops2040a″ and2040b″. Although in the illustrated embodiment the self-lockingmechanisms2015a″ and2015b″ are shown as having a finger-trap-like configuration, other types of self-locking mechanisms, including sliding knots, can be used in place of the illustrated self-lockingmechanisms2015a″ and2015b″.
• Another exemplary embodiment of atissue augmentation tack2010′″ is illustrated inFIG. 21J. The tissue augmentation construct, as shown a tack orbutton2010′″, can be similarly configured as thetack2010 shown inFIG. 21A. Accordingly, as shown, it includes a substantially cylindrical body with a bore orlumen2014′″ extending therethrough from aproximal-most end2010p′″ to adistal-most end2010d′″, and asuture2012′″ received by thelumen2014′″. Similar to thetack2010, a person skilled in the art will recognize that the dimensions of the height H_T′″ and diameter D_T′″ of thetissue augmentation tack2010′″, as well as a diameter of thebore2014′″, can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. In some embodiments a ratio of the diameter D_T′″ of thetack2010′″ to a diameter of thesuture limb2012′″ can be approximately in the range of about 2:1 to about 100:1. More particularly, the diameter D_T′″ can be at least three times greater than the diameter of the filament or suture with which thetissue augmentation tack2010′″ is associated in some instances. In other instances, the diameter D T′ can be at least five times greater than the diameter of the filament or suture with which the tissue augmentation tack, at least ten times greater, at least twenty times greater, or even greater, without departing from the spirit of the present disclosure.
• Thesuture2012′″ includes a self-lockingmechanism2015′″, shown as a sliding knot, associated with anintermediate portion2012i′″ of thesuture2012′″, acollapsible loop2040′″ extending from one side of the slidingknot2015′″, and fixed andtensioning tails2012f″ and2012t′″ extending from an opposite side of the slidingknot2015′″, e.g., extending from thedistal side2010d′″ of thetack2010′″. Alternatively, the self-lockingmechanism2015′″ can be any adjustable and/or sliding mechanism or member (e.g., sliding knot) configured to define thecollapsible loop2040′″ and change a size of the loop by moving the adjustable mechanism with respect to a portion of thesuture2012′″.
• Thetails2012f″ and2012t′″ can operate in a similar manner as thetails2012fand2012t, and thus thetensioning tail2012t′″ can freely slide through thetack2010′″, and can be used to help adjust a diameter of thecollapsible loop2040′″. The slidingknot2015′″ can take a variety of forms, and in the illustrated embodiment it can be formed by creating a knot with the fixedtail2012f″ and passing thetensioning limb2012t′″ of thesuture2012′″ through the slidingknot2015′″. The fixedtail2012f″ can then be secured to thetack2010′″ using any number of techniques known to those skilled in the art for creating a fixed relationship between a suture and an object. For example, the fixedtail2012f″ can form astitch2013′″ through thetack2010′″ to help couple thesuture2012′″ to thetack2010′″. As shown, the fixedtail2012f″ is disposed in a circular pattern within thetack2010′″, thus burying a portion of the fixedtail2012f″ within thetack2010′″ to keep it out of the way. Additionally, or alternatively, alocking knot2016′″ can be formed by the fixedtail2012f″ being tied onto itself to secure thesuture2012′″ to thetack2010′″. In the illustrated embodiment, thelocking knot2016′″ is disposed on thedistal face2010d′″ of thetack2010′″. Alternatively, it is contemplated that thelocking knot2016′″ can be disposed on, or at least proximate to, any surface of thetack2010′″ provided thestitch2013′″ is generally fixed relative to thetack2010′″. Other ways by which the fixedtail2012f″ can be secured with respect to thetack2010′″ include using adhesive, such as glue, to secure a location of the fixedtail2012f″ with respect to thetack2010′″, as well as other techniques known to those skilled in the art.
• In embodiments where thelocking knot2016′″ is disposed on thedistal face2010d′″ of thetack2010′″, the distance between the lockingknot2016′″ and the slidingknot2015′″ can be fixed. For example, a distance extending between the two knots can be approximately in the range of about 2 millimeters to about 10 millimeters. In some embodiments, it may be desirable to maintain the relative distance between the lockingknot2016′″ and the slidingknot2015′″ to be as small as possible to create a low profile repair with the necessary compression of thesoft tissue2030′″ against thebone2050′″.
• Thecollapsible loop2040′″ can be coupled to an implant, e.g., abone anchor2060′″, and a diameter of theloop2040′″ can be adjusted by moving the slidingknot2015′″ proximally away from theanchor2060′″ and distally towards theanchor2060′″ as shown in the illustrated embodiment, for instance by applying a force proximally away from theanchor2060′″ to thetensioning tail2012t′″. Theanchor2060′″ can be a low profile anchor so that theanchor2060′″ can more easily pass through tendon. By way of non-limiting example, theanchor2060′″ can be a toggle anchor, such as a Minilok™ Quickanchor® suture anchor, which is commercially available from DePuy Synthes, Inc. A person skilled in the art will recognize various suitable low profile anchors that can be used in conjunction with the present disclosure, including hard anchors, soft anchors, and other toggle anchors.
• FIG. 21J also illustrates aninserter tool2070′″ that can be used to help insert theanchor2060′″ into a bore formed in bone. Sizes, shapes, and configurations of thetool2070′″ can depend on a variety of factors, including but not limited to the sizes, shapes, and configurations with components with which it is used (e.g., aguide2080′″ and theanchor2060′″), and in the illustrated embodiment a body of thetool2070′″ has a cylindrical or tubular shape. An outer diameter of thetool2070′″ can change along the length of thetool2070′″, and thus, as shown, a first outer diameter at a proximal end2070p′″ has a greater diameter than a second outer diameter at an intermediate portion2070i′″. Aledge2071′″ can be formed by the transition of the body from the first outer diameter to the second outer diameter. As shown, adistal end2070d′″ of thetool2070′″ can be configured to allow theanchor2060′″ to be removably coupled to the tool. Any number of configurations or mechanisms known for creating a releasable connection between an insertion tool and an anchor can be used. For example, the releasable mechanism can be a compression fit, a thread to engage theanchor2060′″, a ball detent, or other releasable mechanisms that can be associated with theinserter tool2070′″ in view of the present disclosures or otherwise known by those skilled in the art. A size and shape of theinserter tool2070′″ can depend on a variety of factors, including a size and shape of the anchor(s) with which it is designed to be used, a size and shape of other components with which it is to be used (e.g., a guide, as described below), and the type of surgical procedure being performed.
• Thetool2070′″ can optionally be used in conjunction with other instruments, such as those provided for inFIGS. 21K and 21L. More particularly,FIG. 21K illustrates aguide2080′″, andFIG. 21L illustrates apunch2090′″, each of which can be used in a variety of procedures, including but not limited to a trans-tendon approach into a bone bore.
• In the illustrated embodiment, a body of theguide2080′″ has a cylindrical or tubular shape with alumen2085′″ extending through an interior volume of theguide2080′″ from a proximal-most end of aproximal end2080p′″ to a distal-most end of adistal end2080d′″ of theguide2080′″, the lumen also having a cylindrical or tubular shape. As shown, an outer diameter of the body of theguide2080′″ changes along the length of theguide2080′″. More particularly, the body is shaped such that theproximal end2080p′″ has a first outer diameter, an intermediate portion2080i′″ has a second outer diameter, and thedistal end2080d′″ has a third outer diameter, with the first outer diameter being greater than the second outer diameter and the second outer diameter being greater than the third outer diameter. In some embodiments, a distal tip of thedistal end2080d′″ can be configured to cut through soft tissue, such as a tendon. Alternatively, thedistal end2080d′″ can have a serrated edge, a blunt edge, a rounded edge, or bone engaging features to grip or otherwise anchor theguide2080′″ to thebone2050′″. Theguide2080′″ can be used to guide instruments, such as thepunch2090′″ andinserter2070′″, and implants, such as theanchor2060′″, throughtendon2030′″ and intobone2050′″.
• As shown, an interior ledge2081′″ can be formed by the transition of the body from the first outer diameter to the second outer diameter, and a taperedportion2083′″ can provide for the transition of the body from the second outer diameter to the third outer diameter. The sizes of the outer diameters, and other portions of theguide2080′″ for that matter, can depend on a variety of factors, including but not limited to the sizes, shapes, and configurations of the instruments with which theguide2080′″ is used (e.g., theinserter tool2070′″,punch2090′″, andanchor2060′″) and the type of procedure being performed. A person skilled in the art will recognize other shapes and configurations of theguide2080′″ andlumen2085′″ are possible, including shapes in which the body of theguide2080′″ and thelumen2085′″ have differently shaped cross sections and/or shapes in which an outer diameter of theguide2080′″ does not change along its length. The diameter of thelumen2085′″ can be sized to receive both thepunch2090′″ and theinserter tool2070′″, or any other surgical tools to be received by theguide2080′″ for use during a surgical procedure.
• A longitudinal slot2088′″ can be formed along a length of theguide2080′″ on an exterior surface of theguide2080′″. In the illustrated embodiment, the slot2088′″ extends an entire length of theguide2080′″ from the proximal-most end of theproximal end2080p′″ to the distal-most end of thedistal end2080d′″, although in other embodiments it can only extend along a portion of the length. The slot2088′″ can have a width W_Gand depth (not shown) that is large enough to accommodate at least onesuture limb2012′″. In some embodiments, more than one slot may be formed in the exterior surface of theguide2080′″. The slot can be formed in the exterior surface using any number of techniques known to those skilled in the art for forming a slot or channel in a surface, including but not limited to etching and milling. The slot2088′″ can help a surgeon control thetack2010′″ with respect to the surgical site since thetack2010′″ may have a diameter that is too big to be disposed through thelumen2085′″ of theguide2080′″.
• As illustrated inFIG. 21L, thepunch2090′″ has a cylindrical or tubular shape, and is configured to be removably disposed through the lumen of theguide2080′″ such that adistal end2090d′″ of thepunch2090′″ can extend distally beyond thedistal end2080d′″ of theguide2080′″ when a proximal end2090p′″ of thepunch2090′″ is engaged with theproximal end2080′″ of theguide2080′″ (seeFIG. 21N). Similar to theguide2080′″, an outer diameter of the body of thepunch2090′″ changes along the length of thepunch2090′″. As shown, the body is shaped such that a proximal end2090p′″ has a first outer diameter, an intermediate portion2090i′″ has a second outer diameter, and thedistal end2090d′″ has a third outer diameter, with the first outer diameter being greater than the second outer diameter and the second outer diameter being greater than the third outer diameter. While the sizes of the first, second, and third outer diameters of thepunch2090′″, as well as other portions of thepunch2090′″, can depend on a variety of factors (e.g., the sizes, shapes, and configurations of theguide2080′″, other components used during a procedure, and the type of procedure being performed), in the illustrated embodiment the first outer diameter is sized such that it is greater than a diameter of thelumen2085′″ of theguide2080′″, and the second outer diameter is less than a diameter of thelumen2085′″ so that thepunch2090′″ can be slidingly and removably received within thelumen2085′″.
• A ledge2091′″ that is formed by the transition from the first outer diameter to the second outer diameter of thepunch2090′″ can be configured to engage the proximal-most end of theproximal end2080p′″ of theguide2080′″. In other embodiments, the first and second outer diameters, and thus the ledge2091′″ can be configured to engage a ledge or other surface disposed within theguide2080′″. When the ledge2091′″ is engaged with theguide2080′″, it prevents thepunch2090′″ from traveling any further in a distal direction with respect to theguide2080′″. Alternatively, or additionally, thepunch2090′″ can include a stop surface2093′″, formed by a tapered portion, that can abut a corresponding surface in theguide2080′″ to prevent any further movement in a distal direction with respect to theguide2080′″. Optionally, thepunch2090′″ can have a lumen extending along at least a portion of the length, including along the whole length, to allow bone and other objects (e.g., tissue) to be removed during bone hole formation, or during other processes that can be performed while thepunch2090′″ is disposed at the surgical site. In some embodiments, thedistal end2090d′″ can be configured to form a bone hole. A person skilled in the art will recognize that components such as theinserter tool2070′″,guide2080′″, and punch2090′″ can be formed of a variety of materials, including but not limited to hardened stainless steel.
• In use, theguide2080′″ can be used to guide both thepunch2090′″ and theinserter tool2070′″ to the implantation site and function to manage thesutures2012′″ during the implantation process, as shown inFIGS. 21M-21R. While the description below describes both the creation of a bone hole2052′″ and soft tissue repair, one skilled in the art will understand that these discrete procedures can be performed separately or in conjunction with other procedures. In one aspect, the procedure can include the creation of a bone hole2052′″ with a trans-tendon approach. Thedistal tip2080d′″ of theguide2080′″ can be advanced to the surgical site such that it is proximate thesoft tissue2030′″, e.g., a tendon. When theguide2080′″ is at the desired location, the operator can advance thepunch2090′″ into the lumen of theguide2080′″. Alternatively, theguide2080′″ can be advanced to the surgical site with thepunch2090′″ already disposed, or partially disposed, therein. The surgeon can push thepunch2090′″ through thetissue2030′″ and into thebone2050′″ to begin to form the bone hole2052′″ by applying a force F1 on thepunch2090′″. The surgeon can apply the force F1 until thepunch tip2090d′″ has been advanced to the desired depth into thebone2050′″ and/or until thedistal end2080d′″ of theguide2080′″ has passed through thetissue2030′″ and is in contact with asurface2050a′″ of thebone2050′″, as shown inFIG. 21N. The amount that thepunch2090′″ is advanced into thebone2050′″ can be limited by the interaction between the ledge2091′″ of thepunch2090′″ and the proximal-most end of theproximal end2080p′″ of theguide2080′″ and/or the interaction between stop surface2091′″ of thepunch2090′″ and a corresponding surface adjacent to thelumen2085′″ of theguide2080′″. Alternatively, or additionally, the stop surface2093′″ of thepunch2090′″ can abut the interior ledge2081′″ of theguide2080′″. In a further alternative, thepunch2090′″ can be advanced into thebone2050′″ without the use of aguide2080′″.
• After the desired bone hole2052′″ has been formed, thepunch2090′″ can be removed from theguide2080′″, thus providing access to the bone hole2052′″ via thelumen2085′″ of theguide2080′″, as shown inFIG. 21O. Theguide2080′″ can be left at the surgical site, or alternatively removed. One advantage to leaving theguide2080′″ in place after the formation of the bone hole2052′″ is that the bone hole2052′″ is easily identifiable for installing ananchor2060′″.
• Similar to the installation of the suture construct shown inFIGS. 21B-21F, theinserter tool2070′″ can be used to insert theanchor2060′″ through the tendon, or other soft tissue,2030′″, as shown inFIG. 21P. The surgeon can insert theinserter tool2070′″ through theguide2080′″ such that theanchor2060′″ is advanced through the lumen of theguide2080′″ by applying a force F2 in a direction as shown. The depth of the insertion can be controlled, at least in part, by the location of theledge2071′″ of theinserter tool2070′″ with respect to a length of theguide2080′″. At least one of thesuture limbs2012′″ can be received within the slot2088′″ of theguide2080′″ so that the suture limbs can be easily managed during the implantation of theanchor2060′″ into the bone hole2052′″ in thebone2050′″. The easy management of thesuture limbs2012′″ likewise allows for easier control of thetack2010′″ as it is advanced towards the surgical site because often thetack2010′″ is too large to be disposed through thelumen2085′″ of theguide2080′″. In some embodiments, thecollapsible loop2040′″ can be collapsed to advance thetack2010′″ at least partially towards the surgical site while theguide2080′″ is still positioned at the surgical site. Alternatively, any adjustment of the size of theloop2040′″ can occur after theguide2080′″ has been removed.
• FIG. 21Q illustrates the surgical site after theguide2080′″ has been removed. Likewise, theanchor2060′″ has been detached from theinserter tool2070′″ and the tool also removed from the surgical site. As shown, theanchor2060′″ has been secured with respect to thebone2050′″ below thetendon2030′″. Theanchor2060′″ can be secured with respect to thebone2050′″ using a number of different techniques, depending, at least in part, on the type of anchor being used. For example, since in the illustrated embodiment theanchor2060′″ is a toggle anchor, a force can be applied to the anchor to toggle it (e.g., a force in an upwards direction away from the surgical site can be applied to thesuture2012′″ to cause theanchor2060′″ to toggle into the bone). If the anchor is a soft anchor, action to actuate the anchor to cause it to secure itself within the bone can be performed. For example, the soft anchor can be formed from a flexible construct (e.g., a suture or filament, among other flexible constructs known to those skilled in the art and/or incorporated by reference herein) such that tensioning of a tensioning tail can actuate the soft anchor from an unstressed configuration (sometimes referred to as an unanchored configuration), in which the soft anchor has a first length and a first diameter, to a stressed configuration (sometimes referred to as an anchored configuration), in which the soft anchor has a second length that is less than the first length and a second diameter that is greater than the first diameter. An anchor formed from a flexible construct does not have to be entirely formed of a flexible construct, but often it is substantially formed of one or more flexible constructs. The soft anchor can be configured to be inserted into a bone hole when in the unstressed configuration and secured at a location, such as at the end of a bone hole, proximate to or otherwise at bone, when in the stressed configuration. The soft anchor can be actuated, for example, by applying tension to the flexible construct to move it from the unstressed configuration to the stressed configuration. Tension can be applied by applying force to a tail or a portion of flexible construct of or otherwise associated with the soft anchor. As noted above, some exemplary embodiments of soft suture anchors and methods for actuating such a soft anchor with the present disclosures include those described in U.S. Pat. No. 9,345,567 of Sengun. In further alternatives, the anchor can be a self-punching anchor, and/or the anchor can be a combination of a self-punching anchor used in combination with an insertion device known to those skilled in the art. Such an anchor and/or anchor-insertion device combination can be inserted directly into bone without forming a bone hole prior to insertion. In cases where a self-punching anchor and/or a self-punching anchor-insertion device combination is used, the procedure can be performed without the use of thepunch2090′″ and/or theguide2080′″, ore equivalents thereof.
• Once theanchor2060′″ is secured in thebone2050′″, tension can be applied to thetensioning tail2012t′″ in the direction F3, as shown inFIG. 21R. As thetensioning tail2012t′″ is pulled, the diameter of thesuture loop2040′″ is reduced and thetack2010′″ is brought into contact to thetendon2030′″ to compress thetendon2030′″ against thebone2050′″. As noted above, in one preferred embodiment the distance between the lockingknot2016′″ and the slidingknot2015′″ is minimized to permit thetendon2030′″ to be compressed as much as is needed against thebone2050′″. If the distance between the lockingknot2016′″ and the slidingknot2015′″ is too great, the surgeon may not be able to achieve the desired amount of compression between thetendon2030′″ and thebone2050′″. The slidingknot2015′″ can be a self-locking knot to maintain a location of thetensioning tail2012t′″ to keep the construct in a locked configuration. Alternatively, if the slidingknot2015′″ is not a self-locking knot, then the surgeon can tie any necessary knots to fix the diameter of thesuture loop2040′″. The tensioning tail can then be trimmed. The fixed tail can likewise be trimmed if it is exposed and it would be desirable to trim it.
• Methods of Manufacturing Tissue Augmentation Constructs
• The tissue augmentation constructs provided for herein can be manufactured using a number of different techniques, some of which are provided for below. Other techniques known to those skilled in the art or developed subsequent to the present disclosure, particularly in view of the present disclosure, can also be used to manufacture the various configurations of tissue augmentation constructs disclosed.
• Methods of Manufacturing Tissue Augmentation Constructs—Blocks Having a Tape Configuration
• In one exemplary embodiment of making a tissue augmentation tape orstrip10, the material being used to make thestrip10 can be cut into a desired shape. For example, in embodiments in which the strip is being manufactured from either autograft tissue, allograft tissue, or xenograft tissue, if the tissue is harvested prior to the procedure, the fresh tissue can be cut into the desired shape, e.g., for thestrip10, a generally rectangular shape having a length L, a width W, and a thickness T as shown inFIG. 1A. Whether the strip is made from harvested material or not, acquisition of the material to make the strip can be achieved using any techniques known to those skilled in the art. In accordance with the present disclosure, the tape orstrip10 can have any shape, for example the tissue can be cut into an oval shape, a circular shape, a triangular shape, etc. Further, the tissue need not be cut with a traditional scalpel or scissors. In some instances it can be sized with the use of a punch, a computer numerical control machine, a laser cutter, or other known manufacturing techniques.
• Once the tissue is formed into the desired shape, a threader can be associated with thestrip10. For example, similar to thesuture limb12aas shown inFIG. 1B, anintermediate filament portion210 of thethreader206 can be threaded through thestrip10 with the use of a running stitch. The stitch can pass back-and-forth across the body of thetape strip10 as many times as desired. In alternative embodiments, theintermediate filament portion210 of thethreader206 can just pass from one of thetape strip10 to the other without ever passing out of the body. After thethreader206 has been installed, thestrip10 can be dried for packaging. Alternatively, thethreader206 can be inserted after the tissue has been dried. Further, thestrip10 need not be dried.
• Methods of Manufacturing Tissue Augmentation Constructs—Blocks Having Tube Configurations
• An exemplary embodiment for making atissue augmentation tube110 is illustrated inFIGS. 22A-22C. The material being used to make thetube110 can be harvested or otherwise acquired using techniques known to those skilled in the art. The material can then be shaped using any of the techniques described above with respect to thestrip10, elsewhere herein, or otherwise known to those skilled in the art. As shown inFIG. 22A, a piece ofmaterial120 can be harvested having a length U and a width W′. The width W′ can be equal to approximately D*π, were D is the diameter of thetube110, as shown inFIG. 2B. As shown inFIG. 22A, the piece ofmaterial120 can be generally rectangular, having afirst end120aand asecond end120bwith the width W′ extending therebetween. Alternatively, the piece ofmaterial120 can have any shape.
• Once the piece ofmaterial120 has been cut out, the first and second ends120a,120bcan be brought proximate to one another and subsequently attached to one another, thereby forming a tube. As shown inFIGS. 22B and 22C, the first and second ends120a,120bare attached using a suture, or filament,122 to stitch the ends together. Alternatively, the first and second ends120a,120bcan be attached to one another with the use of glue, collagen bond, staples, light curing, crosslinking, mechanical interlock, dehydration, or other techniques for attaching soft tissue to soft tissue known to those skilled in the art. Athreader206 can be inserted into thetube110 before the two ends120a,120bare attached, or after. Thetube110 can be dried for packaging. Alternatively, thetube110 can be maintained in a hydrated form, without dehydrating the block110 (this is the case with any construct discussed herein or otherwise derivable therefrom). An alternative method for manufacturing a tissue augmentation tube is provided for inFIGS. 23A-23C. In this method,multiple tubes110a-110ccan be made at a time from a single material, or as shown two pieces of material, one piece disposed above the other.
• As shown, a first piece ofmaterial130aand a second piece ofmaterial130bare placed one on top of the other. Similar to earlier embodiments, the material130a,130bcan be acquired, sized, and shaped using any techniques provided for herein or otherwise known to those skilled in the art. As shown inFIG. 23B, first and second pieces ofmaterial130a,130bcan have a length L′ and a width that is determined as a function of the number oftubes110a-110cdesired. Specifically, eachtube110 has a diameter, or width, D, as noted above. Therefore, the piece of material can have a width that is equal to the number oftubes110 desired multiplied by D. Alternatively, the manufacturing can be planned to allow for a select amount of space to be formed between each strip that is formed. In some embodiments, a single piece of material (not shown) having a generally rectangular shape can be used, with the piece being folded in half to create a first piece of material and a second piece of material as shown, one layered upon the other.
• Once the two pieces ofmaterial130a,130bhave been cut to the desired size, pins132a-132ccan be placed therebetween. The pins132a-132ccan be placed approximately parallel to one another and perpendicular to along edge131 of the material. The pins132a-132ccan be spaced such that there is sufficient space between each pin132a-132cto allow for attachment and separation of theindividual tubes110a-110c.
• As shown inFIGS. 23A-23C, the first and second pieces ofmaterial130a,130bare attached usingsutures134 to stitch the two pieces together to form a tube around thepin132a. Alternatively, the first and second pieces ofmaterial130a,130bcan be attached to one another with the use of glue, collagen bond, staples, light curing, or other known techniques. Once all of thetubes110a-110chave been stitched, theindividual tubes110a-110ccan be cut along lines L₁and L₂. The lines L₁and L₂, as shown inFIG. 23B, are approximately parallel to the pins132a-132c. Once theindividual tubes110a-110chave been cut, the pins132a-132ccan be removed, as shown inFIG. 23C, leaving a bore orlumen114a. Athreader206 can be associated with thelumen114ain manners provided for herein with respect to thelumen114 of thetube110 to pass a suture limb through the lumen.
• This methods of manufacturing tubular constructs can also be used in similar manners to manufacture cannulated constructs like thebars3010,3110 illustrated inFIGS. 2E and 2F. In such instances, the pins132a-132ccan be removed once the cannulations are formed using them, and the two layers ofmaterial130a′,130b′ can be lightly compressed, or can relax by themselves, towards each other. As a result, thelumen114a′ can transform from a tubular shape, as shown inFIG. 23C, to a slit shapedlumen114a′, as shown inFIGS. 2E and 2F. As described above, the overall shape of theconstruct3010,3110 can be generally rectangular prisms. In the construction of theconstruct3010,3110, for example, the use ofpins132a′-132c′ may be omitted altogether. Alternatively, thepins132a′-132c′ may be replaced with skewer blades, not shown, so that the shape of thelumen114c′ starts as a slit rather than starting with a tubular shape.
• A further alternative method for manufacturing a tissue augmentation tube is provided for inFIGS. 24A-24C. This method also allows formultiple tube110a′-110c′ to be made at a time from a single material, or from multiple pieces of material if desired. As shown, a piece ofmaterial130′ can have a length L″ and a width that is determined based upon the number of tubes desired. Specifically, eachtube110a′-110c′ has a diameter, or width, D′. Therefore, the piece of material can have a width that is equal to the number of augmentation blocks110′ desired multiplied by D′. Alternatively, the width can include an additional space X between eachtube110′, which can be accounted for when forming the size of the piece ofmaterial130′. As with any of the embodiments provided for herein, a thickness of the material can vary, depending on a variety of factors, including but not limited to the size and shape of the other components and tissue with which the tube is being used, the anatomy of the patient, and the type of procedure being performed. In some exemplary embodiments, a thickness T′ as illustrated inFIG. 24A, can be approximately in the range of about 0.5 millimeter to about 10 millimeters.
• Once the piece ofmaterial130′ has been cut to the desired size, pins132a′-132c′ can be inserted through the piece ofmaterial130′ from afirst edge130a′ to asecond edge130b′. Thepins132a′-132c′ can be inserted such that they are approximately parallel to one another and approximately perpendicular to the first andsecond edges130a′,130b′ of the material130′. Thepins132a′-132c′ can be spaced such that there is sufficient space between eachpin132a′-132c′ to allow for separation. Thepins132a′-132c′ can be sized to have a diameter that is approximately equal to the diameter of the resultinglumen114″.
• Alternatively, as shown inFIG. 25, atrocar2802 can be used to form alumen114″ in a piece of material. Trocars are generally known to those skilled in the art, and thus a detailed description related to trocars is unnecessary. In fact, in the illustrated embodiment, only a distal end of thetrocar2802 is shown, the distal end including atip2804 and ashaft2806 with which thetip2804 is associated, e.g., coupled. A distal-most end of thetip2804 is pointed and sharp, and is thus configured to puncture tissue. Theshaft2806 of the trocar distally extends from a housing (not shown) to help guide the trocar in the material.
• Thetrocar2802 is unique in comparison to other trocars because theshaft2806 has a gradually increasing diameter in a proximal direction P, i.e., towards the housing. More particularly, thetip2804 has a, substantially constant, diameter D_P1approximately in the range of about 0.10 millimeters to about 1 millimeter, with, as shown, the distal-most tip having a diameter that is even smaller than D_P1. Theshaft2806 has a gradually increasing diameter, starting from the first diameter D_P1and terminating at a second diameter D_P2approximately in the range of about 0.5 millimeters to about 5 millimeters. Other dimensions are certainly possible, depending, at least in part, on the desired lumen size, the instruments with which the trocar will be used, and surgeon preference.
• The gradually increasing diameter of theshaft2806 allows for more precise lumen formation in tissue. By starting with a trocar having a shaft that has a smaller diameter proximate to thedistal tip2804, it is easier to position and advance thetrocar2802 in soft biological tissue. In use, thetip2804 can be positioned, for example, on the first edge of a piece of material and advanced by applying pressure and/or twisting thetrocar2802 as it is advanced towards a second side of the tissue to form an initial lumen. As thetrocar2802 is advanced distally towards the second side, a size of the opening that it forms increases gradually, from D_P1to D_P2. This is different than typical trocars, which generally have a single size shaft associated with a distal tip.
• Turning back toFIGS. 24A-24C, once all of thepins132a′-132c′ have been inserted, theindividual tubes110a′-110c′ can be cut along lines C₁-C₆. The lines C₁-C₆, as shown inFIG. 24B, are approximately parallel to thepins132a′-132c′. Once theindividual tubes110a′-110c′ have been cut, thepins132a′-132c′ can be removed, as shown inFIG. 24C, leaving alumen114a′. Athreader206 can be associated with thelumen114a′ in manners provided for herein.
• The methods of manufacture illustrated herein need not be performed in the order prescribed. For example, with respect to the methods ofFIGS. 23A-23C andFIGS. 24A-24C, the pins132a-132cand132a′-132c′ can be removed before thetubes110a-110cand110a′-110c′ are cut apart. Further, thetubes110a-110cand110a′-110c′ can be dried at any suitable point during the manufacturing process. Moreover, this process can be used to create any number of blocks having any number of shapes or configurations, including but not limited to tubular or rectangular, for example a single tissue augmentation block110aand110a′, two augmentation blocks, or more than three augmentation blocks. Still further, the manufacturing technique provided for with respect to various manufacturing embodiments can be modified in view of the present disclosures to manufacture other tissue augmentation constructs. By way of non-limiting example, blocks having a tape or strip configuration can be formed in view of the present disclosures, thereby allowing multiple strips to be formed from a single piece of material and/or multiple pieces of material stacked on top of each other if such additional thickness and/or additional material is desired. The techniques can likewise be adapted for forming augmentation washers, such as by forming the disclosedblocks110,3010, or3110, and then cutting them along their length to form washers.
• Methods of Manufacturing Tissue Augmentation Constructs—Coring
• In some embodiments of the various tissue augmentation constructs disclosed, including blocks, strips, tubes, bars, washers, patches, and tacks, one or more lumens or cannulations may be formed in a body of the construct. Some techniques for forming such lumens that involve using pins are provided above. Another exemplary technique for creating such lumens involves coring, as shown and described with respect toFIGS. 26A-26I.
• As shown inFIG. 26A, a precut portion of aconstruct2110 having a length L₁and a width W₁can be prepared to be cored. A tool can be used to core theconstruct2110, such as acoring tube2132. Thecoring tube2132 can have ahandle2134 at a proximal end and ahollow tube2136 at a distal end. Thehollow tube2134 of thecoring tube2132 can have adistal edge2138 that can be sharpened or serrated to create a clean cut. Thehollow tube2134 can have a diameter di that is less than the W₁of the construct. The diameter di can be chosen based on the suture size desired for a given procedure.
• As shown inFIG. 26B, thecoring tube2132 can be advanced in the direction S while being rotated in the direction R. The rotation and linear translation of thetool2132 can provide for a cleaner cut; however, the tool can be pushed through only in the direction S, without any rotation. As shown inFIG. 26C, once the distal end of thecoring tube2132 has been advanced along the entire length of theconstruct2110, it can be removed in an opposite direction S′, thereby removing the portion of material2110aand leaving acircular lumen2114. As shown inFIG. 26D, a plurality oflumens2114a-2114ccan be created in asingle construct2110. Alternatively, the construct ofFIG. 26D can be cut into strips that run parallel to thelumens2114a-2114c, thereby forming multiple constructs with each including only one lumen. In a further alternative embodiment, as shown inFIGS. 26E and 26F, at least twobores2114d,2114ecan be created in aconstruct2110 such that they intersect at somelocation2120 in the construct.
• In alternative coring embodiments, illustrated inFIGS. 26G-26I, acurved lumen2114′ can be created using thecoring tube2132′. As shown inFIG. 26G, a generallyU-shaped construct2110′ having first and second generally curved shapededges2110a′,2110b′ and twostraight edges2110c′,2110d′, is prepared to be cored. Similar to the embodiment ofFIG. 26A-26C, acoring tube2132′ is used to core out alumen2114′ through the construct that enters and exits alongedge2110a′. InFIG. 26H, thelumen2114′ is shown as being substantially linear. Once thelumen2114′ has been created, the construct can be stretched, or otherwise rearranged, such that theedges2110a′-d′ are all substantially straight to create a generallyrectangular construct2110′, as shown inFIG. 26I.
• Method of Manufacturing Tissue Augmentation Constructs—Tunneling Station
• In a further alternative method of manufacturing, a construct formation tunneling station is provided. As shown inFIG. 27A, a constructformation tunneling station3200 can include astage3220 for holding a tissue augmentation construct, alumen formation tool3224 for forming a lumen in the construct, and aguide3228 for helping to locate thelumen formation tool3224 with respect to the construct being held by thestage3220.
• In an exemplary embodiment, theconstruct stage3220 can support and guide a piece of material3230 from which constructs can be formed. Theconstruct stage3220 can be a self-centering compression stage to maintain a piece of material3230 at a fixed height through thestage3220. The self-centering of theconstruct stage3220 can be accomplished according to accepted manufacturing techniques. Theconstruct stage3220 can include twostages3220a,3220bwhich are able to move towards and away from one another, Y1, Y2 to self-center and compress thematerial3230. Alternatively, only onestage3220a,3220bcan translate, or thestages3220a,3220bcan be fixed relative to one another. Thefirst stage3220acan have adistal face3219athat is opposed to theproximal face3219bof thesecond stage3220b. Each of thedistal face3219aand theproximal face3219bcan includesemi-circular reliefs3221a,3221bthat are able to accommodate thematerial3230 upon insertion of thelumen formation tool3222, as shown inFIGS. 27B and 27C. Theconstruct stage3220 can include mechanisms, not shown, to advance thematerial3230 in a direction Z to automate the manufacturing process, for instance, as described below with respect toFIG. 27J.
• The constructformation tunneling station3200 can include alumen formation tool3224 that can include aguide3228 and acutting tool3222. In the illustrated embodiment, theguide3228 can generally include alumen3227 and can be fixed relative to theconstruct stage3220 byconnectors3226a,3226bto ensure that the relative orientation of thetool3224 and thestage3220 remains fixed such that the orientation of the lumen within a construct formed by thejig station3200 is within accepted manufacturing tolerances from construct to construct. Alternatively, theguide3228 can be secured to thestage3220 with only one connector, or more than two connectors. Further, while thelumen forming tool3224 is shown physically connected to theconstruct stage3220, alternatively, thetool3224 and thestage3220 can be separate pieces that are fixed relative to one another, e.g., attached to the same work table, to ensure proper lumen forming alignment.
• Acutting tool3222 can be disposed within theguide3228, including by being removably and replaceably associated with theguide3228, such that thetool3222 can freely rotate R and translate X within theguide3228. In some embodiments, thetool3222 can be a needle as shown inFIG. 27D. Alternatively, the cutting tool can be a spear, as shown inFIG. 27E, for example a Premier Edge MVR knife available from Oasis Medical of Glendora, Calif. The spear can include aproximal stem portion3222phaving a substantially circular cross sectional shape and adistal spear portion3222d. The distal spear portion can have a plurality of straightsharp edges3223. The plurality of straightsharp edges3223 can have a smooth transition from theproximal stem portion3222pof the tool.
• In further alternative embodiments thecutting tool3222 can have a number of alternative designs. For example, a trocar as shown inFIG. 27F, a drill bit as shown inFIG. 27G, a coring tube as shown inFIG. 27H, or a straight blade as shown inFIG. 27I. Each of the alternative tools can be used to create a lumen within a construct3210 according to accepted manufacturing techniques provided for throughout the present disclosure.
• In an exemplary method of use, multiple tubes3210a-3210dcan be made at a time from a single length of material, or from multiple pieces of material if desired. As shown, a piece of material3230 can have a length L and a width W. The width W of the material can be the length of the resulting construct while the length L can be determined based upon the number of constructs desired. Specifically, each construct3210a-3210dhas a diameter, or width, D. Therefore, the piece of material can have a length L that is equal to the number of constructs3210 desired multiplied by D. Alternatively, the length L can include an additional space between each construct3210, which can be accounted for when forming the size of the piece ofmaterial3230. As with any of the embodiments provided for herein, a thickness of the material can vary, depending on a variety of factors, including but not limited to the size and shape of the other components and tissue with which the construct is being used, the anatomy of the patient, and the type of procedure being performed.
• Once the piece ofmaterial3230 is advanced into thestage3220, thelumen forming tool3224 can be actuated such that thecutting tool3222 can be inserted through the piece of material3230 from afirst edge3230ato asecond edge3230b, as shown inFIGS. 27I-K. Depending on the type ofcutting tool3222 used, thelumen forming tool3224 can either translate thetool3222 in a direction X, or rotate and translate thetool3222 in the directions X and R into thematerial3230. Actuation of thecutting tool3222 can be performed automatically with an actuator. Alternatively, thecutting tool3222 can be manually actuated by a user. Thecutting tool3222 can then be retracted leaving a lumen3214a-3214c. Thematerial3230 can then be advanced, in the direction Z, a predetermined distance and the process can be repeated to create additional constructs. Individual constructs3210a-3210dcan then be separated from the piece of material3230 as shown inFIGS. 27K and 27L. For example, the individual constructs3210a-3210dcan be separated by means of a punch3290a-3290dor other cutting mechanisms as provided for throughout the present disclosure.
• An alternative construct formingjig station3200′, as illustrated inFIG. 27M, can provide for parallel lumen formation. As shown inFIG. 27M, thestage3220′ can accommodate a larger length L′ of the material3230′. For example, as illustrated inFIG. 27M, thestage3220′ can accommodate a length required to create three constructs. Alternatively, thestage3220′ can extend to accommodate any number of constructs. Thestage3220′ can, similar to the stage of thejig station3200, have semi-circular reliefs and can be self-centering. Similar to the embodiment ofFIGS. 27A-27L, thestation3220′ can include a plurality oflumen forming tools3224a′,3224b′,3224c′ that are each aligned in parallel with each other. Alternatively, the plurality oftools3224a′,3224b′,3224c′ can be oriented at any angle relative to one another. Thelumen forming tools3224a′,3224b′,3224c′ are aligned such that each of the respective cutting tools3222a′,3222b′,3222c′ each translate towards the stage in parallel directions. In the illustrated embodiment threelumen forming tools3224a′,3224b′,3224c′ are shown, however any number of lumen forming tools can be provided for. After each of thelumen forming tools3224a′,3224b′,3224c′ have been actuated and retracted to createlumens3214a′,3214b′,3214c′ in thematerial3230′, thematerial3230′ can be advanced in the direction D′. The individual constructs3210a′,3210b′,3210c′ can be separated according to techniques provided for herein. Alternatively, constructs that include a plurality of lumens can be cut from the material to form patches or scaffolds, as discussed further below.
• Methods of Manufacturing Tissue Augmentation Constructs—General Methods
• The embodiments described above represent some specific techniques associated with manufacturing blocks having particular configurations, e.g., strips, tubes, bars, and washers. More general techniques such as coring are also provided. Such techniques can be adapted by a person skilled in the art for use in other configurations of tissue augmentation constructs in view of the present disclosures. Still further, the present disclosure provides for even more general techniques and methods that can be used to form the various tissue augmentation constructs disclosed herein derivable from the present disclosures. The methods provided for in this section can be used as standalone methods, in conjunction with each other, and/or in conjunction with the other manufacturing techniques provided for in the present disclosure.
• In some embodiments, the constructs can be fully, or partially, manufactured by phase separation techniques, lyophilization, knitting, weaving, electrospinning, rapid prototyping (e.g., 3-D printing) or combinations of thereof. In order to facilitate tissue in growth, perforations can be created in the construct using thermal, electrical, or/and mechanical means, among others. For example, the perforations can be created by a laser or a sharp object such as a needle, punch, or die. The size of a perforation can be any suitable size, but preferably, the perforations are sized to allow tissue in-growth. More preferably, the perforations size can be approximately in the range of about 50 microns to about 2000 microns, and even more preferably, approximately in the range of about 50 microns to about 1000 microns.
• In some embodiments, a biological tissue including, but not limited to, an allograft or xenograft tissue, may, optionally, be incorporated within the various tissue augmentation constructs, thus forming a two-layer construct. The combination of a biological tissue within the various tissue augmentation constructs can provide for enhanced biological performance and mechanical performance of a resulting construct.
• For example, as shown inFIG. 28, a construct2710 (as shown a patch or scaffold, which is described in greater detail below) can include a reconstituted collagen matrix or a biodegradable polymer,2702 or any of the other materials described herein for use in a tissue augmentation construct (e.g., autograft, xenograft, pulverized collagen pieces, porcine dermis, etc.), and a biological component, such as an extracellular matrix (ECM)2704, attached to one side of thematrix2702 using techniques known to those skilled in the art. The reconstituted collagen matrix or biodegradable polymer can be, or can be part of, a first layer, and the biological component can be, or can be part of, a second layer, with a thickness and a surface area of the first layer being larger, and as shown substantially larger, than a thickness and a surface area of the second layer. In other embodiments, the biological component, e.g., theECM2704, can be disposed on opposed sides of thematrix2702 and/or coated or soaked onto thematrix2702. A person skilled in the art will recognize a number of different attachment options that can be used to couple the ECM(s)2704 to thematrix2702, including but not limited to gluing and stitching. The inclusion of theECM2704 or other biological component can help integrate the augmentation construct with the tissue with which the construct is being used. In one exemplary embodiment, thematrix2702 can have a thickness T₁approximately in the range of about 1 millimeter to about 4 millimeters, and the ECM layer can have a thickness approximately in the range of about 80 microns to about 3 millimeters.
• In some embodiments, a biological component can be coated onto the tissue augmentation construct, or incorporated in the tissue augmentation construct. If a biological component is coated onto the tissue augmentation construct, the biological component is preferably associated with at least a portion of the construct. For example, the biocompatible construct can include an adhesion agent for anchoring the suspension of the biological component to a scaffold. The adhesion agent can be an anchoring agent, a cross-linking agent (i.e., chemical or physical), and combinations thereof. Suitable anchoring agents can include, for example, hyaluronic acid, fibrin glue, fibrin clot, collagen gel, alginate gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, polysaccharide-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP), platelet poor plasma (PPP), clot of PRP, clot of PPP, Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, and combinations thereof.
• Cross-linking can be achieved using physical means and chemical agents. Examples of chemical agents used to cross-link can include dehydrothermal (DHT) treatment, divinyl sulfone (DVS), polyethylene glycol divinyl sulfone (VS-PEG-VS), hydroxyethyl methacrylate divinyl sulfone (HEMA-DIS-HEMA), formaldehyde, glutaraldehyde, aldehydes, isocyanates, alkyl and aryl halides, imidoesters, N-substituted maleimides, acylating compounds, carbodiimide, hexamethylene diisocyanate, 1-Ethyl-3-[3-dimethylaminopropyl]carbodiimide hydrochloride (EDC or EDAC), hydroxychloride, N-hydroxysuccinimide, light (e.g., blue light and UV light), pH, temperature, and combinations thereof.
• The biological components can be one or more effectors that promote healing and/or regeneration of the affected tissue at the site of injury. The biological component of a construct can include heterologous or autologous growth factors, proteins, matrix proteins, peptides, antibodies, antibiotics, anti-inflammatories, therapeutic agents, chemotactic agents, antimicrobial agents, antibiotics, anti-inflammatory agents, compounds that minimize or prevent adhesion formation, compounds or agents that suppress the immune system, cell attachment mediators, biologically active ligands, integrin binding sequence, enzymes, cytokines, glycosaminoglycans, polysaccharides, viruses, virus particles, nucleic acids, analgesics, cells, platelets, platelet rich plasma (PRP), minced extracellular particles, minced tissue fragments, hydroxyapatite, tricalcium phosphate, bioactive glass, biphasic calcium phosphate, calcium sulfate, other bone and/or tissue growth-promoting materials, and combinations thereof.
• As described herein, in some embodiments the tissue augmentation construct can have one or more through holes or bores extending therethrough. The through hole(s) can be a slit or a passage with different cross-sectional shapes, for example, circular, elliptical, square, rectangular, etc. The through hole(s) can be created by any tool that can remove materials including mechanical, thermal, or electrical tools. Alternatively, the through hole(s) can be a slit(s) that can be created by any tool that results in the separation of two surfaces.
• In some embodiments, the construct can be made of more than one layer. The layers of the construct can be made of the same material or different materials. The layers can be bonded or fused together using sutures, mechanical, electrical, and chemical fastening techniques. Examples of bonding or fusing can include, for example, tissue welding, staples, rivets, tissue tacks, darts, screws, pins, arrows, cross-linking, vacuum pressing, compression, compression combined with dehydration, vacuum pressing combined with dehydration, or a biological adhesive or a combination of thereof. Dehydration in this context can include, for example, freeze-drying (i.e., lyophilization). Biological adhesives can include, for example, fibrin glue, fibrin clot, collagen gel, alginate gel, gelatin-resorcin-formalin adhesive, mussel-based adhesive, dihydroxyphenylalanine (DOPA) based adhesive, chitosan, transglutaminase, poly(amino acid)-based adhesive, cellulose-based adhesive, polysaccharide-based adhesive, synthetic acrylate-based adhesives, platelet rich plasma (PRP), platelet poor plasma (PPP), clot of PPP, Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, hyaluronic acid, proteoglycans, and combinations thereof.
• In some embodiments the construct can include a reinforcing material. The reinforcing material can be comprised of any absorbable or non-absorbable textile having, for example, woven, knitted, warped knitted (i.e., lace-like), non-woven, and braided structures. In one embodiment, the reinforcing material can have a mesh-like structure. Mechanical properties of the material can be altered by changing the density or texture of the material, the type of knit or weave of the material, the thickness of the material, or by embedding particles in the material.
• Mechanical properties of the reinforcing material can additionally be altered by creating sites within the construct where fibers are physically bonded with each other or physically bonded with another agent, such as, for example, an adhesive or a polymer. The fibers used to make the reinforcing component can be, for example, monofilaments, yarns, threads, braids, or bundles of fibers. These fibers can be made of any biocompatible material including, but not limited to, bioabsorbable materials such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), copolymers or blends thereof. The fibers can also be made from any biocompatible materials based on natural polymers including silk and collagen-based materials. Alternatively, the fibers can also be made of any biocompatible fiber that is nonresorbable, such as, for example, polyethylene, nylon, polyester, polyethylene terephthalate, poly(tetrafluoroethylene), polycarbonate, polypropylene, polyurethane, and poly(vinyl alcohol).
• In another embodiment, the construct may incorporate hydroxyapatite, tricalcium phosphate, Bioglass, biphasic calcium phosphate, calcium sulfate, and other bone-promoting materials within the whole construct or localized in a portion of the construct where bone regeneration is desired. Bioglass is a silicate containing calcium phosphate glass, or calcium phosphate glass with varying amounts of solid particles added to control resorption time. Bioglass is one example of materials that can be spun into glass fibers and used as a reinforcing material. Bioglass can also be incorporated into the construct in a powder form. Suitable solid particles may be added include iron, magnesium, sodium, potassium, and combinations thereof.
• In some embodiments, both the biocompatible construct and the reinforcing material may be formed from a thin, perforation-containing elastomeric sheets with pores or perforations to allow tissue in-growth. A sheet can be made of blends or copolymers of polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and polydioxanone (PDO).
• The construct can be formed partially or completely from a polymeric foam component, having pores with an open cell pore structure. The pore size can vary, but preferably, the pores are sized to allow tissue in-growth. In some embodiments, the pore size is approximately in the range of about 40 microns to about 1000 microns, and in other embodiments, the pore size is approximately in the range of about 50 microns to about 500 microns. The polymeric foam component can be made from natural or/and synthetic materials, such as reconstituted collagen. The polymeric foam can be non-crosslinked or crosslinked. The polymeric foam component can, optionally, contain a reinforcing component, such as for example, textiles as discussed above. In some embodiments, the polymeric foam component can contain a reinforcing component which can be integrated with the reinforcing component such that the pores of the foam component penetrate the mesh of the reinforcing component and interlock with the reinforcing component.
• In some embodiments the polymeric foam component of the tissue implant may be formed as a foam by a variety of techniques well known to those having skill in the art. For example, the polymeric starting materials may be foamed by lyophilization, supercritical solvent foaming, which is described at least in European Patent Application No. 464,163, the contents of which is incorporated by reference herein in its entirety, gas injection extrusion, gas injection molding or casting with an extractable material (e.g., salts, sugar, or similar suitable materials).
• A polymeric foam component of engineered tissue repair implant devices of the present disclosure may be made by a polymer-solvent phase separation technique, such as lyophilization. A polymer solution can be separated into two phases by any one of the four techniques: (a) thermally induced gelation/crystallization; (b) non-solvent induced separation of solvent and polymer phases; (c) chemically induced phase separation, and (d) thermally induced spinodal decomposition. The polymer solution can be separated in a controlled manner into either two distinct phases or two bi-continuous phases. Subsequent removal of the solvent phase usually leaves a porous structure with a density less than the bulk polymer and pores in the micrometer ranges. Additional information about the solvent phase is provided in Microcellular Foams via Phase Separation, J. Vac. Sci. Technol., A. T. Young, Vol. 4(3), May/June 1986, the contents of which is incorporated by reference herein in its entirety.
• The steps involved in the preparation of these foams include, for example, choosing the right solvents for the polymers to be lyophilized and preparing a homogeneous solution. Next, the polymer solution can be subjected to a freezing and vacuum drying cycle. The freezing step phase can separate the polymer solution and vacuum drying step can remove the solvent by sublimation and/or drying, leaving a porous polymer structure or an interconnected open cell porous foam. Suitable solvents that may be used in the preparation of the foam component can include, for example, formic acid, ethyl formate, acetic acid, hexafluoroisopropanol (HFIP), cyclic ethers (e.g., tetrahydrofuran (THF), dimethylene fluoride (DMF), and polydioxanone (PDO)), acetone, acetates of C2 to C5 alcohols (e.g., ethyl acetate and t-butylacetate), glyme (e.g., monoglyme, ethyl glyme, diglyme, ethyl diglyme, triglyme, butyl diglyme and tetraglyme), methylethyl ketone, dipropyleneglycol methyl ether, lactones (e.g., γ-valerolactone, δ-valerolactone, β-butyrolactone, γ-butyrolactone), 1,4-dioxane, 1,3-dioxolane, 1,3-dioxolane-2-one (ethylene carbonate), dimethlycarbonate, benzene, toluene, benzyl alcohol, p-xylene, naphthalene, tetrahydrofuran, N-methylpyrrolidone, dimethylformamide, chloroform, 1,2-dichloromethane, morpholine, dimethylsulfoxide, hexafluoroacetone sesquihydrate (HFAS), anisole, and mixtures thereof. Among these solvents, one exemplary solvent is 1,4-dioxane. A homogeneous solution of the polymer in the solvent is prepared using standard techniques.
• The applicable polymer concentration or amount of solvent that may be utilized can vary with each system. In one embodiment, the amount of polymer in the solution can vary from about 0.5% to about 90% by weight. In another embodiment, preferably, the amount of polymer in the solution can vary from about 0.5% to about 30% by weight. The amount of polymer in the solution can vary depending on factors such as the solubility of the polymer in a given solvent and the final properties desired in the foam.
• In embodiments of the construct that include a polymeric foam, solids may be added to the polymer-solvent system to modify the composition of the resulting polymeric foam surfaces. As the added particles settle out of solution to the bottom surface, regions will be created that will have the composition of the added solids, not the foamed polymeric material. Alternatively, the added solids may be more concentrated in desired regions (i.e., near the top, sides, or bottom) of the resulting tissue augmentation construct, thus causing compositional changes in all such regions. For example, concentration of solids in selected locations can be accomplished by adding metallic solids to a solution placed in a mold made of a magnetic material (or vice versa).
• A variety of types of solids can be added to the polymer-solvent system. In one embodiment, the solids are of a type that will not react with the polymer or the solvent. The added solids can have an average diameter of less than about 2 millimeters. In other embodiments, added solids can have an average diameter of about 50 microns to about 1000 microns. The solids can be present in an amount such that they will constitute from about 1 volume to about 50 volume percent of the total volume of the particle and polymer-solvent mixture (wherein the total volume percent equals 100 volume percent).
• Exemplary solids include, for example, particles of demineralized bone, calcium phosphate particles, Bioglass particles, calcium sulfate, or calcium carbonate particles for bone repair, leachable solids for pore creation and particles of bioabsorbable natural polymers, bioabsorbable synthetic polymers, non-bioabsorbable materials, minced extracellular particles, minced tissue fragments, or any biocompatible materials that is not soluble in the solvent system.
• Exemplary leachable solids include, for example, nontoxic leachable materials such as salts (e.g., sodium chloride, potassium chloride, calcium chloride, sodium tartrate, sodium citrate, and the like), biocompatible mono and disaccharides (e.g., glucose, fructose, dextrose, maltose, lactose and sucrose), polysaccharides (e.g., starch, alginate, chitosan), water soluble proteins (e.g., gelatin and agarose). Leachable materials can be removed by immersing the foam with the leachable material in a solvent in which the particle is soluble for a sufficient amount of time to allow leaching of substantially all of the particles. The solvent can be chosen so that it does not dissolve or detrimentally alter the foam. One preferred embodiment can include water as the extraction solvent, for example distilled-deionized water. Such a process is described further in U.S. Pat. No. 5,514,378, the contents of which is incorporated by reference herein in its entirety. Preferably the foam will be dried after the leaching process is complete at low temperature and/or vacuum to minimize hydrolysis of the foam unless accelerated absorption of the foam is desired.
• Non-bioabsorbable materials can include, for example, bioinert ceramic particles (e.g., alumina, zirconia, and calcium sulfate particles), polymers such as polyethylene, polyvinylacetate, polymethylmethacrylate, polypropylene, poly(ethylene terephthalate), silicone, polyethylene oxide, polyethylene glycol, polyurethanes, polyvinyl alcohol, natural polymers (e.g., cellulose particles, chitin, and keratin), and fluorinated polymers and copolymers (e.g., fluoride, polytetrafluoroethylene, and hexafluoropropylene). In one embodiment, it is possible to add solids (e.g., barium sulfate) that will render the tissue implants radio opaque. Those solids that may be added also include those that will promote tissue regeneration or healing, as well as those that act as buffers, reinforcing materials or porosity modifiers.
• As discussed above, polymeric foam components can contain a reinforcing component. The construct can be made by injecting, pouring, or otherwise placing, the appropriate polymer solution into a mold set-up comprised of a mold and the reinforcing elements of the present disclosure. The mold set-up can be cooled in an appropriate bath or on a refrigerated shelf and then lyophilized, thereby providing a reinforced construct.
• In embodiments that utilize a polymeric foam, one or more of the biological components provided for throughout the present disclosure can be added either before or after the lyophilization step. In the course of forming the polymer foam component, it can be beneficial to control the rate of freezing of the polymer-solvent system. The type of pore morphology that is developed during the freezing step is a function of factors such as the solution thermodynamics, freezing rate, temperature to which it is cooled, concentration of the solution, and whether homogeneous or heterogeneous nucleation occurs. The orientation of the polymeric fibers can be regulated be controlling the pore orientation. The pores orientation in the polymeric form component can be customized, for example, by controlling the temperature gradient induced during the freezing cycle. Controlling the orientation of fibers can result in an improvement in the mechanical properties in the direction that the fibers are oriented.
• The required general processing steps for a construct that uses polymeric foam can include the selection of the appropriate materials from which the polymeric foam will be made. The processing steps can additionally include selection of the materials of the reinforcing components if used. If a mesh reinforcing material is used, the proper mesh density should be selected. Further, the reinforcing material should be properly aligned in the mold, the polymer solution should be added at an appropriate rate and, preferably, into a mold that is tilted at an appropriate angle to avoid the formation of air bubbles, and the polymer solution must be lyophilized.
• In embodiments that utilize a mesh reinforcing material in a polymeric foam, for example, the reinforcing mesh should be selected to be of a certain density. That is, the openings in the mesh material should not be so small so as to impede proper bonding between the foam and the reinforcing mesh as the foam material and the open cells and cell walls thereof penetrate the mesh openings. Without proper bonding the integrity of the layered structure can be compromised, leaving the construct fragile and difficult to handle. The density of the mesh can determine the mechanical strength of the construct. The density of the mesh can vary according to the desired use for tissue repair. In addition, the type of weave used in the mesh can determine the directionality of the mechanical strength of the construct, as well as the mechanical properties of the reinforcing material, such as for example, the elasticity, stiffness, burst strength, suture retention strength, and ultimate tensile strength of the construct. By way of non-limiting example, the mesh reinforcing material in a foam-based biocompatible construct of the present disclosure can be designed to be stiff in one direction, yet elastic in another, or alternatively, the mesh reinforcing material can be made isotropic.
• During lyophilization of the reinforced foam in those embodiments that utilize a mesh reinforcing material in a polymeric foam, several parameters and procedures can be helpful to produce implants with the desired integrity and mechanical properties. For example, if reinforcement material is used, it can be beneficial to maintain the reinforcement material substantially flat when placed in the mold. To ensure the proper degree of flatness, the reinforcement (e.g., mesh) can be pressed flat using a heated press prior to its placement within the mold. Further, in the event that reinforcing structures are not isotropic, it can be desirable to indicate this anisotropy by marking the construct to indicate directionality. The marking can be accomplished by embedding one or more indicators, such as dyed markings or dyed threads, within the woven reinforcements. The direction or orientation of the indicator can, for example, indicate to a surgeon the dimension of the implant in which physical properties are superior.
• In embodiments that utilize polymeric foam, as noted above, the manner in which the polymer solution is added to the mold prior to lyophilization can help contribute to the creation of a tissue implant with adequate mechanical integrity. Assuming that a mesh reinforcing material will be used, and that it will be positioned between two thin (e.g., approximately 0.75 millimeters) shims, the mesh can be positioned in a substantially flat orientation at a desired depth in the mold. The polymer solution can be poured in a way that allows air bubbles to escape from between the layers of the foam component. The mold can be tilted at a desired angle and pouring is effected at a controlled rate to best prevent bubble formation. A number of variables will control the tilt angle and pour rate. For example, the mold should be tilted at an angle of greater than about one degree to avoid bubble formation. In addition, the rate of pouring should be slow enough to enable any air bubbles to escape from the mold, rather than to be trapped in the mold.
• In those embodiments that utilize a mesh reinforcing material in a polymeric foam, the density of the mesh openings can be an important factor in the formation of the construct with the desired mechanical properties. For example, a low density, or open knitted mesh material, can be used. One example of such a material is a 90:10 copolymer of glycolide and lactide, sold under the tradename VICRYL, which is available from Ethicon, Inc. of Somerville, N.J. One exemplary low density, open knitted mesh is Knitted VICRYL VKM-M, which is also available from Ethicon, Inc. of Somerville, N.J. Other materials can include but are not limited to polydioxanone and a 95:5 copolymer blend of lactide and glycolide.
• In embodiments that utilize a polymeric foam, a through opening can be created by placing a rod in the polymeric foam solution/slurry before it has set. After the polymeric form is formed, the rod can be removed. For example, if the polymeric foam is made by lyophilization, the rod is removed after the freeze and vacuum drying cycle. The rod can have any desired shape.
• The polymeric foam component can, optionally, contain one or more layers made of the materials discussed above. In one embodiment, the foam component can be integrated with the material(s) by creating pores in the materials and then the polymeric foam component penetrate the pores created in the materials(s) and interlock with the material(s). In another embodiment, pores are formed in materials of two layers, and the two layers are put together to best align the pores. The two layer combination can be placed in a polymeric solution or slurry, and the polymeric foam can be formed by one of the methods provided for herein or otherwise known to those skilled in the art.
• In some embodiments, a construct can be formed from an expanding media that can advantageously provide added compression at the repair site. One non-limiting example of such aconstruct2910 is shown inFIG. 29A, in which the construct is a patch or scaffold (as described in greater detail below). For example, theconstruct2910 can be formed from a woven or braided mesh having acore2904 surrounded or sandwiched between twolayers2902a,2902b. The twolayers2902a,2902bcan be referred to as a jacket. Thecore2904 can be made from a variety of materials that are capable of expanding, such as silicone loaded with salt, sodium polyacrylate, polyacrylamide copolymer, polyurethanes, and other absorbent polymers and hydro gels, while thejacket2902a,2902bcan be more rigid so that the core can compress against the jacket as it expands in use. Non-limiting exemplary materials that can be used to form thejacket2902a,2909binclude fabric and filament such as polyethylene, polypropylene, polyester, poly(ethylene terephthalate), nylon, polyurethanes and silk. Further non-limiting exemplary materials that can be used to form thejacket2902a,2902binclude bioabsorbable materials such as polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), polydioxanone (PDO), trimethylene carbonate (TMC), copolymers or blends thereof. Some materials that can be used in conjunction with the construct include, but are not limited to, those disclosed and provided for in U.S. Pat. No. 8,870,915, entitled “Joining Element,” the contents of which is incorporated by reference herein in its entirety. Theconstruct2910 can have a length L_Pand a thickness T_P, as shown inFIG. 29A, and can include at least onesuture limb2911 for affixing the construct to one or more repair sites. In the illustrated example theconstruct2910 includes foursuture limbs2911,2912,2913,2914 associated with it. The limbs can be from the same or different sutures.
• In use, as shown inFIG. 29B, theconstruct2910 can be placed over therepair sites2938a,2938b, and thesuture limbs2911,2912,2913,2914 can be fixed withinrespective anchors2961,2962,2963,2964. As with other disclosures, the repairs associated with therepair sites2938a,2938bcan be any type of repair provided for herein or otherwise known to those skilled in the art. Theconstruct2910 can be further affixed to a location medial of therepairs2938a,2938bwith sutures, staples, or other devices and components used to fixate tissue with respect to bone. As shown, sutures2940a-2940cprovide the fixation. Theconstruct2910 can be exposed to an aqueous solution, for example after installation, such that the silicone and salt filled core can absorb the fluid to cause the construct to expand in at least one dimension and contract in at least one other dimension based on the configuration of theconstruct2910. In the illustrated example, the expansion causes theconstruct2910 to increase in thickness T_Pwhile contracting and decreasing across its length L_P. The decrease in the length L_Pafter theconstruct2910 is installed can increase the compressive forces to thesoft tissue2930 to bring the tissue into more uniform contact with thebone2950 due, at least in part, to the limited space for fixation of theconstruct2910, the configuration of theconstruct2910, and the surface geometry of the attachment site. One skilled in the art will appreciate that a configuration of a construct having a core, capable of expanding, sandwiched between layers or a jacket can be used with other construct configurations provided for herein, including those that are not necessarily a patch or scaffold, to provide for added compressive forces at repair sites. A further discussion of tissue augmentation patches and scaffolds is provided below.
• Unless specified otherwise, any of the materials, and any of the techniques disclosed for forming materials, can be used in conjunction with any of constructs provided for herein. This includes any combination of materials. Likewise, the manufacturing techniques disclosed can generally be used, or adapted to form the various constructs provided for herein. The use of materials and manufacturing techniques for various tissue augmentation constructs is within the spirit of the present disclosure.
• Tissue Augmentation Constructs—Tissue Augmentation Patches
• Tissue augmentation constructs can also come in form of a patch or scaffold that can be associated with one or more limbs of suture to increase a footprint of the one or more limbs and to provide additional surface area across which forces to be distributed, among other benefits articulated throughout the present disclosure, e.g., enhancing healing of otherwise compromised tissue and/or providing bulk to otherwise compromised or degenerate tissue and/or tendon. The patches can be disposed on, or even attached or coupled, to the suture rather than just sitting on top of operative sutures. Further, the instant patches can be delivered to the surgical site and threaded onto sutures using a suture threader as described herein, thereby obviating the need for extensive suturing of each edge of a patch. A number of different techniques can be used to associate the illustrated patches with suture, including threading the suture through the patch and/or disposing the suture in between layers of a scaffold. The patch can then be disposed proximate to a surgical site as described. Methods of manufacturing a scaffold or patch, and methods of installing various scaffolds and patches, are also provided for below. The systems and methods disclosed herein allow for quick, easy, and affordable techniques for preventing damage to tissue by tensioned suture. Like the other constructs described above, a surgeon can apply the patch(es) in an on-demand manner to create desired suture footprints for the repair. A person skilled in the art will recognize that the disclosures provided for herein related to tissue augmentation blocks, e.g., by way of non-limiting example, the materials used to form the tissue augmentation blocks10,110,3010,3110,310,410, among other constructs, can be applied to the patches discussed below.
• One exemplary embodiment of a tissue augmentation construct2210 having a patch or scaffold configuration is provided for inFIGS. 30A and 30B. As shown, thetissue augmentation patch2210 has a rectangular-shaped body and can be disposed on or otherwise associated withsuture limbs2212a,2212b. In the illustrated embodiment thepatch2210 includes bores orlumens2214a,2214bare formed in the body and extend therethrough from aproximal-most end2210pto adistal-most end2210d. Thebores2214a,2214bcan be used, for example, to receive thesuture limbs2212a,2212bso that thepatch2210 andlimbs2212a,2212bcan be associated with each other. As shown inFIG. 30B, thepatch2210 can be pre-threaded withsuture threaders2206a,2206b. Thethreaders2206a,2206bare of a similar nature as thethreader206′, and can also be configured in a manner akin to thethreader206 or in manners otherwise known to those skilled in the art and/or derivable from the present disclosures. As shown, thepatch2210 has a length L_Pthat is substantially equal to a width W_P, and it also has a thickness T_P. Further, the thickness T_Pcan be greater than a diameter of a filament or suture with which thetissue augmentation patch2210 is associated, e.g., thesuture limb2212a.
• A person skilled in the art will recognize that the dimensions of the length L_P, the width W_P, and the thickness T_Pof thetissue augmentation patch2210, as well as a diameter of thebores2214a,2214b, can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. Some exemplary, non-limiting dimensions for atissue augmentation patch2210 can be useful in understanding the present disclosure.
• In some embodiments, the length L_Pcan cover a significant portion, to almost an entire portion, of a length of tissue extending between a stitch made in tissue and a bone anchor used to help secure the tissue. In some embodiments, the length L_Pand width W_Pcan be approximately in the range of about 10 millimeters to about 50 millimeters, and the thickness T_Pcan be approximately in the range of about 0.5 millimeters to about 5 millimeters. The size of the diameter of thebores2214a,2214bcan also depend on a variety of factors, including but not limited to the size of the limb to be passed therethrough. In some embodiments, the diameter can be approximately in the range of about 0.5 millimeters to about 3 millimeters.
• A number of techniques known to those skilled in the art can be used to associate thepatch2210 with thesuture limbs2212a,2212b.Suture limbs2212a,2212bcan be threaded or passed from theproximal-most end2210pto thedistal-most end2210dof thepatch2210 without passing across the body of thepatch2210, i.e., without passing through sidewalls that define thebores2214a,2214b. As a result, thepatch2210 can freely pass along a length of thelimbs2212a,2212bunhindered or unrestricted. In other embodiments, thelimbs2212a,2212bcan pass across the body once or more, e.g., like the embodiment of the strip ortape10 illustrated inFIG. 1B, to further secure a location of thepatch2210 with respect to thelimbs2212a,2212b. In still other embodiments, thelimbs2212a,2212bcan be passed through thepatch2210 from theproximal-most end2210pto thedistal-most end2210dby passing through the body while only entering and exiting the body one time, for instance when nobores2214a,2214bare provided. Of course, thelimbs2212a,2212bdo not necessarily have to extend all the way to the proximal-most or distal-most ends2210p,2210d, but instead can enter and or exit thepatch2210 at some other location across its surface area. A person skilled in the art will recognize a variety of other ways by which thepatch2210 can be associated with thelimbs2212a,2212bwithout departing from the spirit of the present disclosure.
• Thetissue augmentation patch2210 can be threaded by hand on to thesuture limbs2212a,2212b, either at the surgical site, or outside of the body. Alternatively, as shown inFIG. 30B, thethreaders2206a,2206bcan be operated to associated thesuture limbs2212a,2212bwith thepatch2210, with the operation being akin to either thethreader206 or thethreader206′ described above, and thus includingproximal handle portions2208a,2208b, intermediateelongate portions2207a,2207b, and distal suture-receiving ends2209a,2209b. Accordingly, thetissue augmentation patch2210 can be associated with the intermediateelongate portions2207a,2207b, as shown by passing the intermediateelongate portions2207a,2207bthrough thelumens2214a,2214b, and thelimbs2212a,2212bcan be coupled to the distal suture-receiving ends2209a,2209b. Theproximal handle portions2208a,2208bcan be grasped and pulled away from thetissue augmentation patch2210 to advance thelimbs2212a,2212btowards and into thepatch2210. After thepatch2210 has been successfully associated with thelimbs2212a,2212b, thethreaders2206a,2206bcan be disassociated with thelimbs2212a,2212band thetissue augmentation patch2210 and can be either discarded or re-used.
• Similar to the earlier described tissue augmentation strips, associating thetissue augmentation patch2210 with thesuture limbs2212a,2212bincreases the footprint of thesuture limbs2212a,2212band may allow force applied to the tissue by thesuture limbs2212a,2212bto be distributed over a larger amount of surface area, i.e., the surface area of thepatch2210. The increased distributed force of thetissue augmentation patch2210 may result in a reduced pressure peak on the soft tissue. Where the soft tissue has become degenerated due to injury or age, an increased tissue surface area coverage and a reduction in pressure can result in less chance of abrasion of the tissue. Further, the larger surface area of thetissue augmentation patch2210 can provide for a larger scaffold for new tissue to generate over the repair to further strengthen the repair site. The broader tissue coverage provided by thepatch2210 may enhance the healing of otherwise compromised tissue and/or provide bulk to otherwise compromised or degenerate tissue and/or tendon.
• Methods of Manufacturing Tissue Augmentation Constructs—Tissue Augmentation Patches
• Thetissue augmentation patch2210 can be manufactured using a number of different techniques, some of which have been previously discussed above with regards to the tissue augmentation blocks10,110. In one exemplary embodiment of making a tissue augmentation patch, illustrated byFIGS. 30C-30E, the material being used to make thepatch2210 can be harvested or otherwise acquired using techniques known to those skilled in the art. The material can then be shaped using any of the techniques described above, for instance those described with respect to thestrip10, or otherwise known to those skilled in the art in view of the present disclosures. A piece of material can be harvested having a length L_P, a width 2W_P, and a thickness ½ T_P. The width 2W_Pcan be double the resulting width W_Pof thepatch2210 and the thickness ½ T_Pcan be half of the thickness of the resultingpatch2210. As shown inFIG. 30D, the piece of material2220 can have afirst end2220aand asecond end2220bwith the width 2W_Pextending therebetween. Alternatively, the piece of material2220 can have any shape.
• Once the piece of material2220 has been cut out, twopins2222a,2222bcan be placed onto the same side of the material, approximately ¼ of the width 2W_Paway from the first andsecond ends2220a,2220b, respectively. The two ends2220a,2220b, can be folded over therespective pins2222a,2222b, and brought proximate to one another and subsequently attached to one another, thereby forming thepatch2210. As shown inFIGS. 30C and 30D, the four rows of stitches2224a-2224dcan be stitched into the folded patch such that they are substantially parallel to one another. Further, the first and thefourth stitches2224a,2224dcan be located substantially parallel to and proximate thepins2222a,2222b, respectively. Still further, thestitches2224a,2224dcan create the twolumens2214a,2214bthat are held open by thepins2222a,2222b. After the stitching is complete, thepins2222a,2222bcan be removed, leaving thepatch2210 as shown inFIG. 30E. Alternatively, no pins are required to manufacture thepatch2210. The second and thethird stitches2224b,2224ccan be located substantially parallel to and proximate the two ends2220a,2220b. Further alternatively, in place of stitches, the material2220 can be secured to itself with the use of glue, collagen bond, staples, light curing, or other techniques known to those skilled in the art for attaching soft tissue to soft tissue and provided for throughout the present disclosure. In embodiments that include threaders predisposed in thepatch2210,threaders2206a,2206bcan be inserted into thelumens2214a,2214bbefore the two ends2220a,2220bare attached, or after. Like the other constructs provided for herein, the patch2220 can be dried for packaging at any suitable point during the manufacturing process.
• An alternative method of manufacturing thepatch2210 can include harvesting a piece of material that can be harvested having a length L_P, a width W_P, and a thickness T_P. The piece of material2220 can have afirst end2220aand asecond end2220bwith the width W_Pextending therebetween. Afirst pin2222acan be inserted, or pierced, into the material2220 proximate and parallel to thefirst end2220ato create afirst lumen2214a. Asecond pin2222bcan be inserted, or pierced, into the material2220 proximate and parallel to thesecond end2220bto create asecond lumen2214b. In a further alternative, a coring tube can be used in place of thepins2222a,2222b, as described above with respect toFIGS. 26A-26I. Thepatch2210 can be made from any of the materials provided for above with respect to theblocks10,110,3010,3110,310, and410, and any other constructs, noted above. Furthermore, thepatch2210 can have any shape, including rectangular, trapezoidal, ovoid, circular, square, pentagonal, hexagonal, octagonal, etc.
• A further alternative method of manufacturing apatch3320 can include the use of a parallelproduction tunneling station3300, similar to thetunneling stations3200,3200′ ofFIGS. 27A-27M. As shown inFIG. 31A, astage3320 can accommodate a larger length L of thematerial3330. For example, as illustrated inFIG. 31A, thestage3320 can accommodate twopatch constructs3310a,3310b. Alternatively, thestage3320 can extend to accommodate any number of constructs. Thestage3320 can, similar to the stage of thetunneling station3200′, have a plurality of semi-circular reliefs that can be aligned withlumen formation tools3324a,3324b,3324c,3324d, and thestage3320 can be self-centering.
• Similar to thetunneling stations3200,3200′ ofFIGS. 27A-27M, thetunneling station3300 can include a plurality oflumen formation tools3324a,3324b,3324c,3324d. In the illustrated embodiment, thelumen formation tools3324a,3324bforms afirst station3323a, and thelumen formation tools3324c,3324dforms asecond station3323b. As shown, thelumen formation tools3324a,3324bcan be angularly offset from one another, for example approximately up to about 30 degrees from one another. In one embodiment, thelumen formation tools3324a,3324bcan be angularly offset from one another approximately 16 degrees from one another. Thelumen formation tools3324c,3324dof thesecond station3323bcan be similarly offset relative to one another, or alternatively, can be angularly offset at a different angle. Thesecond station3323bcan be disposed on an opposite side of thestage3320 from thefirst station3323a, thus providing for easier parallel lumen formation. In an alternative embodiment, each of thelumen forming tools3324a,3324b,3324c,3324dcan be aligned in parallel with each other. Thelumen formation tools3324a,3324b,3324c,3324dcan be aligned such that each of the respective cutting tools3322a,3322b,3322c,3322dcan translate towards the stage to create thelumens3314a,3314b,3314c,3314din thematerial3330. In the illustrated embodiment, twolumen formation stations3323a,3323bare shown, however any number of lumen forming stations can be provided.
• After each of thelumen formation tools3324a,3324b,3324c,3324dhas been actuated and retracted to createlumens3314a,3314b,3314c,3314din thematerial3330, thematerial3330 can be advanced in the direction D as shown inFIG. 31A. The individual constructs3310a,3310b,3310ccan then be separated by means of a punch3190a-3190c, or other cutting mechanisms as provided for throughout the present disclosure or otherwise known to those skilled in the art. The resulting constructs3310a,3310b,3310c,3310dare illustrated inFIGS. 31B and 31C, with the resultingpatches3310a,3310b,3310c,3310dhaving a generally trapezoidal shape. A person skilled in the art will recognize that any number of patch shapes can be formed in view of the present disclosures. For example, thelumen formation tools3324a,3324b,3324c,3324dcan be parallel to each other to create patches having parallel lumens and a rectangular shape.
• Methods of Use—Tissue Augmentation Patches
• One exemplary method of installing atissue augmentation patch2210 is illustrated inFIG. 30F. The illustrated method provides for a piece ofsoft tissue2230, e.g., rotator cuff, fixated tobone2250. Either a single row or a double row repair can be used. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation patch have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can perform a tissue repair (not visible because it is underneath the patch2210) according to accepted surgical techniques. As shown inFIG. 30F, asuture2212 extending from an anchor (not shown) used in the repair is installed into thetissue2230 medially from the repair such that twosuture limbs2212a,2212bextend out from thetissue2230.
• Thetissue augmentation patch2210 can be threaded onto thesuture limbs2212a,2212busing techniques provided for throughout the present disclosure, and subsequently advanced along therespective suture limbs2212a,2212buntil it is proximate amedial stitch2242. After thetissue augmentation patch2210 has been installed on thesuture limbs2212a,2212b, the free end of eachsuture limb2212a,2212bcan be secured within the body. For example, the free ends of eachsuture limb2212a,2212bcan be coupled torespective anchors2260a,2260bin a lateral row fixation. Thesuture limbs2212a,2212bcan then be tightened to secure thepatch2210 against the repair before theanchors2260a,2260bare fully fixed in thebone2250.
• Thetissue augmentation patch2210 can provide a greater footprint for thesuture limbs2212a,2212band a greater surface area to distribute the loading forces of thesuture limbs2212a,2212bonto thesoft tissue2230. While the patient is healing from the procedure, the patch can remodel into tendon-like tissue and integrate with the underlying native tissue. The additional coverage of tendon-like tissue across the soft tissue can increase the strength of the soft tissue to bone connection and may prevent further injury.
• Another exemplary method of installing atissue augmentation patch2210′ is provided for inFIGS. 30G-30I, this time illustrating a piece ofsoft tissue2230′, e.g., rotator cuff, being fixated tobone2250′ using a double row repair. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation patch have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can install first and secondmedial anchors2260a′,2260b′ in thebone2250′. The first and secondmedial anchors2260a′,2260b′ havesutures2212′,2216′ associated therewith. As shown inFIG. 30G, sutures2212′ and2216′ can havesuture limbs2212a′,2212b′ and2216a′,2216b′ extending from therespective anchors2260a′ and2260b′, with the limbs being threaded through thetissue2230′, for example using one or moremedial stitches2242a′,2242b′.
• Thepatch2210′ can have similar properties as thepatch2210 and can be threaded onto thesuture limbs2212a′,2216a′ using techniques provided for throughout the present disclosure. Thepatch2210′ can subsequently be advanced in the direction D₁along therespective suture limbs2212a′,2216a′, as shown inFIG. 30H, until it is proximate themedial stitches2242a′,2242b′. After thepatch2210′ has been installed on thesuture limbs2212a′,2216a′, the free end of each of thesuture limbs2212b′,2216b′ can be placed over thepatch2210′ in an X- or crossed configuration as shown inFIG. 30I. Then thesuture limbs2212a′,2216b′ can be installed intolateral anchor2262a′, and thesuture limbs2212b′,2216a′ can be installed intolateral anchor2262b′ in a lateral row fixation. Thesuture limbs2212a′,2212b′,2216a′,2216b′ can then be tightened to secure thesoft tissue2230′ to thebone2250′ before the lateral anchors2262a′,2262b′ are fully fixed in thebone2250′. The same benefits described above with respect to the method of using thepatch2210 are equally applicable to this embodiment of using thepatch2210′. Further, the crossed nature of the suture configuration provides additional stability for holding thetissue2230′ at the desired location with respect to thebone2250′.
• A further exemplary embodiment of installing atissue augmentation patch2210″ is illustrated inFIGS. 30J-L and can be used with either a single or double row repair described above with regards toFIGS. 30F-I. The illustratedpatch2210″ has been threaded ontosuture limbs2212a″,2216a″ according to techniques provided for throughout the present disclosure. The illustrated method provides for forming collapsible loops2212l″,2216l″ and associatedknots2270a″,2270b″ disposed on adistal end2210d″ of thepatch2210″. The collapsible loops2212l″,2216l″ and associatedknots2270a″,2270b″ can be formed onrespective suture limbs2212a″,2216a″ after the suture limbs have been threaded through thepatch2210″. In one exemplary embodiment the knots can be, for example, sliding knots, figure eight knots, or finger traps, among other knot types. Theknots2270a″,2270b″ can be larger than the associated lumens through which thesuture limbs2212a″,2212b″ are threaded through such that theknots2270a″,2270b″ cannot be pulled through. Theknots2270a″,2270b″ can be formed after thepatch2210″ has been advanced in the direction D1 until it is proximate thesoft tissue2230″.
• After the loops2212l″,2216l″ have been formed, thesuture limb2216b″ can be guided through the loop2212l″ and thesuture limb2212b″ can be guided through the loop2216l″, as illustrated inFIG. 30K. Once thesuture limbs2212b″,2216b″ have been threaded through the suture loops2212l″,2216l″, the suture limbs are beneficially maintained in a desired configuration. Thesuture limbs2212a″,2216b″ can then be installed into alateral anchor2262a″, and thesuture limbs2212b″,2216a″ can be installed into alateral anchor2262b″ in a lateral row fixation. At this point, the collapsible loops2212l,2216l″ can be collapsed by the application of a force onsuture limbs2212a″,2216a″, thereby securingsuture limbs2212b″,2216b″ in an X- or crossed configuration as shown inFIGS. 30K and 30L. Thesuture limbs2212a″,2212b″,2216a″,2216b″ can then be tightened to secure thesoft tissue2230″ to thebone2250″ before the lateral anchors2262a″,2262b″ are fully fixed in thebone2250″. One benefit of theknots2270a″,2270b″ and loops2212l″,2216l″ is that thepatch2210″ can be prevented from sliding laterally towardsanchors2262a″,2262b″ and fixed relative to thebone2250″ and2230″. By collapsing the loops2212l″,2216l″ around thesutures limbs2212a″,2212b″,2216a″,2216b″, unintentional sliding of thepatch2210″ with respect to thesutures limbs2212a″,2212b″,2216a″,2216b″ can be prevented. The loops and knots can be beneficially applied to any of the constructs provided for herein to prevent lateral sliding and to retain the construct after implantation, including but not limited to tissue augmentation blocks and tissue augmentation patches.
• Tissue Augmentation Constructs—Additional Tissue Augmentation Patches, Methods of Using the Same, and Methods of Manufacturing the Same
• Another exemplary embodiment of a tissue augmentation construct2310 having a patch or scaffold configuration is illustrated inFIG. 32A. As shown, thetissue augmentation patch2310 has a rectangular-shaped body and is generally similar in nature and construction to thetissue augmentation patch2210. Thepatch2310 differs in that it includes additional lumens2314a-2314dextending therethrough from aproximal-most end2310pto adistal-most end2310dfor having threaders2306a-2306d, and thus suturelimbs2312a,2312b,2316a,2316bafter operating the threaders2306a-2306d, disposed therein. Optionally the threaders2306a-2306dmay not be used and thesuture limbs2312a,2312b,2316a,2316bmay be associated with thepatch2310 using any technique provided for herein or otherwise known to those skilled in the art. As shown inFIG. 32A, thelumens2314a,2314dcan be substantially parallel to the sides of thepatch2310 that extend between theproximal-most end surface2310pand thedistal-most end surface2310d, and thelumens2314b,2314ccan form a substantially X-shaped or crossed configuration. When thethreaders2306aand2306bare associated with thepatch2310 in the illustrated embodiment, or in other embodiments illustrated herein having a patch with two threaders associated therewith, anintermediate portion2307aof thefirst threader2306acan be disposed at a location that is more proximate to afirst side2310aof thepatch2310 than a second,opposite side2310bof the patch and anintermediate portion2307bof thesecond threader2306bcan be disposed at a location that is more proximate to thesecond side2310bthan thefirst side2310a. When thethreaders2306cand2306dare also associated with thepatch2310, anintermediate portion2307cof the third threader can be disposed diagonally with respect to thepatch2310 such that adistal receiving end2309cof thethird threader2306cis proximate to adistal receiving end2309aof thefirst threader2306a, while aproximal handle2308cof thethird threader2306cis proximate to aproximal handle2308bof thesecond threader2306b, and anintermediate portion2307dof the fourth threader can be disposed diagonally with respect to thepatch2310 such that adistal receiving end2309dof thefourth threader2306dis proximate to adistal receiving end2309bof thesecond threader2306b, while aproximal handle2308dof thefourth threader2306dis proximate to aproximal handle2308aof thefirst threader2306a.
• A person skilled in the art will recognize that in any embodiments in which multiple threaders are used in conjunction with a construct, a location of the proximal and distal ends of the threaders can be different than the illustrated embodiments, depending, at least in part, on the type of procedure being performed, the components being used to perform the procedure, and the preferences of the user. Thus, in any illustrated embodiments, locations of the proximal and distal ends of the threaders can be switched in other embodiments. Further, in any of the illustrated embodiments, a location of any threader with respect to a tissue augmentation construct prior to using the threaders to associate a suture with the tissue augmentation construct is considered a pre-installation configuration, and after a threader has been used to associate a suture with a tissue augmentation construct and subsequently removed, such a configuration is considered a post-installation configuration.
• As shown, thepatch2310 has a length L_P′ that is substantially equal to a width W_P′, and it also has a thickness T_P′. Further, the thickness T_P′ can be greater than a diameter of a filament or suture with which thetissue augmentation patch2310 is associated, e.g., thesuture limb2312a. In other embodiments, thesuture limbs2312a,2312b,2316a,2316bcan extend through the lumens2314a-2314dwithout necessarily having been disposed in the lumens2314a-2314dusing threaders. Thelimbs2312a,2312b,2316a,2316bcan extend in the same hybrid parallel and crossed configuration illustrated and described with respect to the locations of the threaders2306a-2306d.
• A person skilled in the art will recognize that the dimensions of the length L_P′, the width W_P′, and the thickness T_P′ of thetissue augmentation patch2310, as well as a diameter of the bores2314a-2314d, can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. Alternatively, thepatch2310 can have any other shape (e.g., rectangular, trapezoidal, ovoid, circular, square, pentagonal, hexagonal, octagonal, etc.) and the lumens2314a-2314dcan follow any path (e.g., they can follow edges). The exemplary, non-limiting dimensions provided above for thepatch2210 can also be applicable to the size of thepatch2310, with the understanding that other dimensions are possible. Likewise, a number of techniques known to those skilled in the art can be used to associate thepatch2310 with thesuture limbs2312a,2312b,2316a,2316b, and the techniques described above with respect to thepatch2210 can be adapted for use in conjunction with thepatch2310. Thus, in view of the present disclosures, a person having skill in the art will understand how to operate the threaders2306a-2306dto associate thesuture limbs2312a,2312b,2316a,2316bwith thepatch2310.
• One exemplary method of installing thepatch2310 is provided for inFIGS. 32B-32E. The illustrated method provides for a piece ofsoft tissue2330, e.g., rotator cuff, fixated tobone2350. Either a single row or a double repair can be used. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation patch have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can performsingle row repairs2340a,2340bof thetissue2330 according to accepted surgical techniques. Alternatively, one repair can be made to thetissue2330, or more than two repairs can be completed. As shown inFIG. 32C, afirst suture2312 can be inserted into thetissue2330 medially from therepairs2340a,2340bsuch that twosuture limbs2312a,2312bextend out from thetissue2230, and likewise, asecond suture2316 can be inserted into thetissue2330 medially from therepairs2340a,2340bsuch that twosuture limbs2316a,2316bextend out from thetissue2230. In the illustrated embodiment, thesutures2312,2316 are inserted into thetissue2330 usingmattress stitches2342a,2342b, respectively, though other stitches can be used.
• As shown inFIG. 32D, thesuture limbs2312a,2312b,2316a,2316bare threaded into lumens2314a-2314d, respectively, using techniques provided for throughout the present disclosure, e.g., operating the threaders2306a-2306d, and thepatch2310 can be advanced along therespective suture limbs2312a,2312b,2316a,2316buntil theproximal end2310pis proximate themedial stitches2342a,2342b. After thepatch2310 has been installed on thesuture limbs2312a,2312b,2316a,2316b, the free end of eachsuture limb2312a,2316bcan be secured within the body. For example, as shown inFIG. 32E, the free ends of eachsuture limb2312a,2316band2312b,2316acan be coupled tolateral anchor2362aand2362b, respectively, in a lateral row fixation. Thesuture limbs2312a,2312b,2316a,2316bcan then be tightened to secure thepatch2310 against the repair2340 before the lateral anchors2360a,2360bare fully fixed in thebone2350.
• Another exemplary method of installing atissue augmentation patch2310′ is provided for inFIGS. 32F-32H, this time illustrating a piece ofsoft tissue2330′, e.g., rotator cuff, being fixated tobone2350′ using a double row repair. Once the surgeon has access to the surgical site and the tissue, bone, and patch have been prepared according to accepted surgical techniques including those provided for herein, the surgeon can install first and secondmedial anchors2360a′,2360b′ in thebone2350′. The first and secondmedial anchors2360a′,2360b′ havesutures2312′,2316′ associated therewith. As shown inFIG. 32F,sutures2312′ and2316′ can havesuture limbs2312a′,2312b′ and2316a′,2316b′ extending from therespective anchors2360a′ and2360b′, with the limbs being threaded through thetissue2330′, for example using one or moremedial stitches2342a′,2342b′.
• Thepatch2310′ can have similar properties as thepatch2310 and can be threaded ontosuture limbs2312a′,2312b′,2316a′,2316b′ using techniques provided for throughout the present disclosure. Thepatch2310′ can subsequently be advanced along thesuture limbs2312a′,2312b′,2316a′,2316b′ until theproximal end2310p′ is proximate themedial stitches2342a′,2342b′, as shown inFIGS. 32G and 32H. After thepatch2310′ has been installed on thesuture limbs2312a′,2312b′,2316a′,2316b′, the free ends of each of thesuture limbs2312a′,2316b′ and2312b′,2316a′ can then be installed into respective lateral anchors2362a′ and2362b′ in a lateral row fixation. Thesuture limbs2312a′,2312b′,2316a′,2316b′ can then be tightened to secure thepatch2310′ against the repair2340′ before the lateral anchors2360a′,2360b′ are fully fixed in thebone2350′. The same benefits described above with respect to the method of using thepatch2210′ are equally applicable to the embodiments of using thepatches2310 and2310′, including the benefits resulting from the crossed nature of the suture configuration. Additional benefits of these two embodiments will also be clear to those having skill in the art in view of the present disclosures.
• Thepatch2310 can be manufactured using a number of different techniques, some of which have been previously discussed above at least with regards to the tissue augmentation blocks10,110 and other constructs. Thepatch2310, and thus also thepatch2310′, can be made from any of the materials provided for above with respect to the tissue augmentation blocks10,110,3010,3110,310, and410, and/or other constructs described herein. In one exemplary embodiment of making a patch, illustrated byFIGS. 32I and 32J, the material being used to make thepatch2310 can be harvested or otherwise acquired using the same techniques as described above with respect to thepatch2210. As shown inFIG. 32I, the piece of material2320 can have afirst end2320aand asecond end2320bwith the width 2W_P′ extending therebetween. Alternatively, the piece of material2320 can have any shape.
• Once the piece ofmaterial2320 has been cut out, the two ends2320a,2320b, can be folded over approximately ¼ of the width 2W_P′ away from the first andsecond ends2320a,2320b, respectively, and brought proximate to one another and subsequently attached to each other, thereby forming thepatch2310. As shown inFIG. 32J, thepatch2310 is stitched together to form the folded patch. The stitching2324a-2324dis performed such that the twoparallel lumens2314a,2314bare created in combination with the X shapedlumens2314c,2314d. Thefirst stitch2324acan be substantially V-shaped, having both ends located at the distalmost end2310dof the patch2130 and the vertex of the V-shape pointing towards the proximalmost end2310pof the patch2130. Thesecond stitch2324bcan be substantially V-shaped, having both ends located at the proximalmost end2310pof the patch2130 and the vertex of the V-shape pointing towards the distalmost end2310dof the patch2130. The third andfourth stitches2324c,2324dcan be substantially triangular in shape and can be substantially mirror images of the other to define thelumens2314a,2314d. Alternatively, pins can be placed along where the lumens2314a-2314dare to be located, and then thepatch2310 can be stitched together to manufacture thepatch2310. The pins can be removed once the patch is manufactured. Further alternatively, in place of stitches thematerial2320 can be secured to itself with the use of glue, collagen bond, staples, light curing, or other techniques for attaching soft tissue to soft tissue known to those skilled in the art and provided for throughout the present disclosure.
• In embodiments that include threaders predisposed in thepatch2310, threaders2306a-2306dcan be inserted into the lumens2314a-2314dbefore the two ends2320a,2320bare attached, or after. Thepatch2320 can be dried for packaging at any suitable point during the manufacturing process. Further alternatives for forming thepatch2310 in accordance with the present disclosures include but are not limited to harvesting a piece of material and using pins to pierce or puncture it to create the lumens2314a-2314d, as described at least with respect toFIGS. 30C-30E, and/or using a coring device or tube to create the lumens2314a-2314d, as described at least with respect toFIGS. 26A-26I.
• Many more configurations of patches and sutures are within the scope of the present disclosures. Configurations can be derived from making adjustments to various parameters or variables provided for and discussed throughout the present application. Some parameters or variables that can be changed to provide for various configurations include: (1) the number of layers used to form the patch (e.g., one layer, two layers); (2) the orientation of a first set of suture limbs with respect to each other and the patch (e.g., across the patch in a manner in which the limbs are not intersecting, across the patch in a manner in which the limbs intersect each other); (3) a location of a second set of suture limbs with respect to the patch (e.g., on top of the patch, through the patch); (4) the orientation of the second set of suture limbs with respect to each other and the patch (e.g., across the patch in a manner in which the limbs are not intersecting, across the patch in a manner in which the limbs intersect each other); (5) the inclusion of one or more “stitches” with the first set of suture limbs, referred to herein as “loops” and “jogs,” to fixate the patch with respect to at least one suture limb; (6) whether the second set of suture limbs is disposed in lumens formed in the patch; (7) whether additional sutures are provided (e.g., medial center suture, lateral center suture); and (8) a location of the first set of suture limbs with respect to the second set of suture limbs (e.g., inside of the second set of suture limbs, outside of the second set of suture limbs).
• A small sample of some patch configurations illustrating options for the above-listed parameters or variables is shown inFIGS. 33A-33E. Some configurations can be better than others in aiding patch delivery and/or aiding the attachment of the patch to soft tissue. One skilled in the art will understand that the various parameters can be mixed and matched to arrive at a large number of configurations, many of which are not explicitly illustrated herein, but are derivable based on the understanding provided about each of the variables and the constructs more generally as disclosed in the present application. To assist in understanding some of the options associated with the above-listed parameters, each parameter is discussed in more detail below with a limited number of example configurations illustrated. However, it is contemplated that the instant disclosure encompasses each discrete combination of parameters in conjunction with many of the different patch configurations provided for in the present disclosure. Further, like reference numbers are used across each of the examples illustrated inFIGS. 33A-33E as the parameters are interchangeable across various configurations using the same materials (e.g., patch, sutures, and anchors).
• One parameter that can be changed to achieve various patch configurations is the number of layers that form each patch. For example, each patch can include a single layer of material with lumens being formed in the single layer for disposing suture limbs therethrough, as illustrated inFIGS. 26D-26F, 30A, 30B, and 31A-31C. The single layer can include a tissue-facing or tissue-engaging surface, also referred to herein as abottom side3410dof thepatch3410, and a second surface that is opposed to the tissue-facing surface (e.g., the surface that is visible inFIGS. 33A-33E), also referred to herein as atop side3410pof thepatch3410. Alternatively, each patch can include two or more layers of material stitched together to form a single patch with lumens being formed between two or more layers for disposing suture limbs therethrough, as illustrated inFIGS. 32A-32J. When a second layer is used, each layer includes a tissue-facing surface and a second surface that is opposed to the tissue-facing surface. In such embodiments, the tissue-facing surface of the patch is formed by the tissue-facing surface of the bottom, or more distal, patch, and the second surface of the patch that is opposed to the tissue-facing surface is formed by the second surface of the top, or more proximal, patch. Even in patches that include multiple layers, a lumen can be formed in a single layer. In embodiments where the patch includes two layers, the stitching can form lumens as described with reference toFIGS. 32A-32J. For the sake of simplicity, a first set ofsuture limbs3412,3414 and a second set ofsuture limbs3416,3418 will be referenced in the following discussion, however a single set may be used. As discussed above, in embodiments where two layers of material are used, each layer can be formed from different materials to provide a variety of advantages, including but not limited to: the overall thickness of the patch configuration may not limited by a biological source, a level of cellular activity can be controlled (e.g., a high tissue integration layer on a tissue facing side and an adhesion barrier layer on the opposite side), and other material characteristics can be varied between each layer (e.g., toughness, biologic/synthetic, thick/thin, high-/low-porosity, etc.).
• As shown inFIG. 33A, two inverted mattress stitches3440a,3440bcan be formed in the soft tissue, medial to any repairs (the repairs not being shown). More particularly, afirst suture3411acan be used to form a firstinverted mattress stitch3440aand asecond suture3411bcan be used to form a secondinverted mattress stitch3440b. Thefirst mattress stitch3440acan result insuture limb3412 andsuture limb3416 extending therefrom, and thesecond mattress stitch3440bcan result insuture limb3414 andsuture limb3418 extending therefrom. For the purposes of discussion only,suture limbs3412 and3414 are defined as a first set of suture limbs, andsuture limbs3416 and3418 are defined as a second set of suture limbs. For the sake of simplicity, each of the embodiments shown inFIGS. 33A-33E illustrates two mattress stitches and therefore a discussion will not be repeated for each figure.
• Further, as shown in each embodiment, thesuture limbs3412,3414 of the first set of suture limbs are generally through thepatch3410. This can include configurations in which thesuture limbs3412,3414 extend through thepatch3410 for an entire length of the patch, that is from themedial edge3410M to the opposedlateral edge3410L, or configurations in which thesuture limbs3412,3414 extend through thepatch3410 for a portion of the length. Generally thesuture limbs3412,3414 extend along a length that extends substantially between the medial and opposedlateral edges3410M,3410L. For example, as shown inFIG. 33D, thesuture limbs3412,3414 do not extend the entire length of thepatch3410, but do extend a substantial portion of that length. The substantial portion of the length can be at least about 50 percent of the length, or alternatively at least about 75 percent of the length, or further alternatively at least about 90 percent of the length.
• As thesuture limbs3412,3414, and thesuture limbs3416,3418 are passed through the patch, they are passed by leading a terminal end of the suture limb through, above, and/or below a portion of thepatch3410. The terminal end that is described as being passed through the patch in the illustrated embodiments can be considered a terminal lateral end since that is the end that is being passed towards thelateral edge3410L and towards illustratedanchors3460a,3460b. When terminal lateral ends are described as being coupled to an anchor, a person skilled in the art will recognize that it is not the terminal lateral end of the suture limb itself that necessarily is attached to the anchor because when associating a suture with an anchor, the terminal end may extend some distance beyond the anchor, for instance as a result of tying the suture to the anchor. Thus, a description of a terminal lateral end of a suture limb being attached or otherwise coupled to an anchor does not require that the very end of the suture itself is touching or coupled directly to the anchor. Rather, it just indicates that some portion of that limb that a person skilled in the art would understand in view of the present disclosure qualifies as a terminal end of the system when forming the patch-suture configuration is the described terminal lateral end. Further, as shown, theanchors3460a,3460bare disposed on opposite sides of a centrallongitudinal axis3410cextending between the medial andlateral sides3410M,3410L of thepatch3410. Generally, when the terminal lateral ends of the various suture limbs are being associated with the anchor, the terminal lateral ends can be described as being proximate to each other. A person skilled in the art will recognize that even if the terminal lateral ends are associated with different anchors on the same side of the scaffold, and/or associated with one or more other fixtures (including but not limited to bone, tissue, and medical implants) on the same side of the scaffold, the terminal lateral ends of the suture limbs on that side can still be described as being proximate to each other in view of the present disclosure.
• A second parameter that can be changed to achieve various patch configurations relates to the orientation of the first set of suture limbs with respect to each other and the patch. For example, each of the first set ofsuture limbs3412,3414 can be disposed across thepatch3410 from amedial edge3410M to alateral edge3410L in a manner such that the limbs do not intersect each other, as shown inFIG. 33A. In the illustrated embodiment, thelimbs3412,3414 extend substantially parallel to respective outer side edges3410S,3410T of thepatch3410 and are disposed on separate halves of the centrallongitudinal axis3410c. This configuration can provide for added securement of theedges3410S,3410T when thelimbs3412,3414 are extended over the edges. A person skilled in the art will recognize that thelimbs3412,3414 can be oriented in many other manners with respect to each other and thepatch3410 without causing them to intersect. For example, the first set ofsuture limbs3412,3414 can be disposed across thepatch3410 from themedial edge3410M to thelateral edge3410L in a manner such that the limbs extend substantially straight across thepatch3410 and are thus substantially parallel to one another. Examples of limbs configured in such a manner are illustrated at least inFIGS. 30A-30L (e.g.,limbs2212aand2212b,limbs2212a′ and2216a′, andlimbs2212a″ and2216a″).
• In a further alternative, the first set ofsuture limbs3412,3414 can be disposed across thepatch3410 from themedial edge3410M to thelateral edge3410L in a manner such that the limbs do intersect each other. For example, thelimbs3412,3414 can be disposed across thepatch3410 to form an “X” configuration or shape, like thelimbs2212b′ and2216b′ ofFIG. 30I, thelimbs2312b,2316bofFIGS. 32A-32E, thelimbs2312b′,2316b′ ofFIGS. 32F-32H, andlimbs3416 and3418 ofFIG. 33B (which are described as the second set of limbs but are referenced for purposes of generally showing an intersecting configuration). This configuration can provide for a more distributed compression over a larger area of the construct. A person skilled in the art will recognize that thelimbs3412,3414 can be oriented in many other manners with respect to each other and thepatch3410 while still intersecting each other. Further, to the extent thelimbs3412,3414 are described as being disposed across the patch, they can extend across a top surface of the patch, through the patch (e.g., through a single layer, disposed between two layers), or a combination of both across the top surface of the patch and through the patch. Additionally, thelimbs3412,3414 do not have to be oriented in a similar manner. For example, thelimb3412 can extend substantially parallel to theouter side edge3410S, or extend substantially straight across thepatch3410 with thelimb3412 remaining on one side of the centrallongitudinal axis3410c, while thelimb3414 extends more diagonally such that it crosses over the centrallongitudinal axis3410c.
• A third parameter that can be changed to achieve various patch configurations relates to a location of a second set of suture limbs with respect to the patch. For example, the second set ofsuture limbs3416,3418 can be disposed through the patch as they extend from themedial edge3410M to thelateral edge3410L, similar to the orientation of thelimbs2312band2316bandlimbs2312b′ and2316b′ ofFIGS. 32A-32J. Advantageously, when at least one suture limb is disposed through the patch, the patch can be more secure after installation. Alternatively, the second set ofsuture limbs3416,3418 can be disposed over a top surface of thepatch3410, similar to the orientation of thelimbs2212band2216b,limbs2212b′ and2216b′, andlimbs2212b″ and2216b″ ofFIGS. 30A-30L. In some instances, some portion of any second limbs can extend through the patch while some other portion extends on top of the patch, and the configuration of this parameter for any limb does not have to be the same as any other limb.
• A fourth parameter that can be changed to achieve various patch configurations relates to the orientation of the second set of suture limbs with respect to each other and the patch. For example, each of the second set ofsuture limbs3416,3418 can be disposed across thepatch3410 from themedial edge3410M to thelateral edge3410L in a manner such that the limbs do not intersect each other, or in a manner such that they do intersect. Such configuration possibilities are similar to those discussed above with respect to the second parameter, which was for the orientation of the first set of suture limbs with respect to each other and the patch. Further, in some instances thesecond suture limbs3416,3418 may not extend over or through thepatch3410, but rather, may extend around and/or adjacent to thepatch3410.First suture limbs3412,3414 can also be configured in a manner in which at least a portion of them extend around and/or adjacent to thepatch3410 rather than on top of or through the patch.
• By way of non-limiting example,FIG. 33A illustrates an embodiment in which the second set oflimbs3416,3418 do not intersect and extend around and adjacent to thepatch3410; thus, thelimbs3416,3418 do not extend over or through thepatch3410. By way of further non-limiting examples,FIGS. 33C and 33E each illustrate embodiments in which the second set oflimbs3416,3418 do not intersect and extend on top of thepatch3410. As shown inFIG. 33D, it is possible to combine various orientations across the length extending between the medial andlateral edges3410M and3410L. For example, as shown thelimbs3416,3418 do not intersect, but the orientation of the limbs with respect to thepatch3410 changes as the limbs extend between the medial andlateral edges3410M and3410L. More particularly, as shown, afirst portion3416p₁,3418p₁of each of thelimbs3416,3418 extends around and/or adjacent to thepatch3410, asecond portion3416p₂,3418p₂of each of thelimbs3416,3418 extends on top of thepatch3410, and athird portion3416p₃,3418p₃of each of thelimbs3416,3418 extends through thepatch3410. The orientation of the first set ofsuture limbs3412,3414 can likewise have different configurations across their length.
• FIG. 33B, on the other hand, provides for an embodiment in which the second set ofsuture limbs3416,3418 do intersect. As shown, thelimbs3416,3418 are disposed across the patch3410 (as shown, through the patch), to form an “X” configuration or shape, like thelimbs2212band2216b′ ofFIG. 30I, thelimbs2312b,2316bofFIGS. 32A-32E, and thelimbs2312b′,2316b′ ofFIGS. 32F-32H. An “X” configuration can provide for a more distributed compression over a larger area of the construct. A person skilled in the art will recognize that thelimbs3416,3418 can be oriented in many other manners with respect to each other and thepatch3410 while still intersecting each other. Further, while in the illustrated embodiment ofFIG. 33B thelimbs3416,3418 extend through thepatch3410, they can also extend across a top surface of the patch and/or around or adjacent to the patch, or any combination thereof. Likewise, limbs extending through the patch can extend through a single layer and/or be disposed between two layers.
• A fifth parameter that can be changed to achieve various patch configurations relates to the inclusion of one or more “stitches” in conjunction with the first set of suture limbs. As described in the present disclosure, these “stitches” can be referred to as “loops,” as shown and described with respect toFIG. 33C, and “jogs,” as shown and described with respect toFIG. 33D. As described in greater detail below, the stitches for loops and jogs both involve passing a terminal end of the suture limb through at least a portion of the patch (e.g., through a proximal-most surface of the patch) and then to and through the lateral edge of the patch. Loops can involve the suture limb passing an entire length of the patch extending between the medial and lateral edges, while jogs can involve the suture limb passing through a portion of the length that is not necessarily the entire length (although it can be a substantial portion of the length). The loops and jogs are used to help fixate the patch with respect to at least one suture limb.
• As illustrated inFIG. 33C, a loop stitch orloop3444acan be formed by passing asuture limb3412 from thebottom side3410dof thepatch3410, which faces thesoft tissue3430, to thetop side3410pof thepatch3410 at alocation3408aproximate to themedial edge3410M. Thelocation3408acan be a preformed lumen, or it can be a lumen formed while advancing thesuture limb3412 through thepatch3410, for instance because the material of thepatch3410 is braided such that thelimb3412 can be passed through it. Thepatch3410 can include at least onelateral lumen3407a,3407bthat extends from themedial edge3410M to thelateral edge3410L. Alternatively, thelumens3407a,3407bmay not be preformed or exist and may instead just be locations within thepatch3410 through which filament can be passed, for instance between two layers or through a single layer that has a material conducive to having a material passed therethrough. Thesuture3412 can then be threaded medially to enter thelumen3407aat themedial edge3410M and extend through the lumen to thelateral edge3410L. Once tension is applied to theloop3444aand the loop is brought into contact with thepatch3410, thesuture limb3412 can be fixed relative to thepatch3410 such that thepatch3410 will not drift along thesuture3412 after implantation. Theloop3444acan also provide for additional stability during patch installation. This process can be repeated forsuture limb3414 to form a second loop stitch orloop3444b. Theloops3444a,3444bcan be formed in vivo, or alternatively can be formed before the patch is introduced into the surgical site using patch delivery systems described below. The free end of eachsuture limb3412,3416 and3414,3418, also referred to herein as terminal lateral ends, can then be secured within the body using techniques provided for throughout the present disclosure. For example, as shown inFIG. 33C, the free ends of eachsuture limb3412,3416 and3414,3418 can be coupled tolateral anchor3460aand3460b, respectively, in a lateral row fixation. Thesuture limbs3412,3414,3416,3418 can then be tightened to secure thepatch3410 against the repair before the lateral anchors3460a,3460bare fully fixed in thebone3450.
• Alternatively, in place of a loop, thesuture limb3412 of the first set ofsuture limbs3412,3414 can be used to form a jog. As illustrated inFIG. 33D, a jog stitch or jog3446acan be formed by passing thesuture limb3412 from thebottom side3410dof thepatch3410 to thetop side3410pof thepatch3410 at alocation3408aproximate to themedial edge3410M, and then advancing thesuture limb3412 towards theouter edge3410S before passing thesuture limb3412 back into thepatch3410 from thetop side3410pand towards thebottom side3410d. Thesuture limb3412 can then be advanced towards thelateral side3410L. In the illustrated embodiment, thesuture limb3412 is passed through alateral lumen3407athat extends from themedial edge3410M to thelateral edge3410L. Alternatively, thelumen3407a, and/or its illustratedcounterpart lumen3407b, may not be preformed or exist and may instead just be locations within thepatch3410 through which filament can be passed, for instance between two layers or through a single layer that has a material conducive to having a material passed therethrough. Like with the embodiment inFIG. 33C, thelocation3408acan be a preformed lumen, or it can be a lumen formed while advancing thesuture limb3412 through thepatch3410, for instance because the material of thepatch3410 is braided such that thelimb3412 can be passed through it. As shown, the portion of thelimb3412 extending through thepatch3410 extends a substantial portion of the length of the limb that extends between the medial andlateral edges3410M and3410L, but not the entire length.
• When forming thejog3446a, thesuture3412 can be advanced towards theouter edge3410S any desired distance based, at least in part, on the size of thepatch3410 and desired configuration of the patch and suture combination. By way of non-limiting example, in some embodiments thejog3446acan extend substantially perpendicular to the centrallongitudinal axis3410cand can have a length approximately in the range of about 1.0 millimeters to about 5.0 millimeters away from thelocation3408a. Once tension is applied to thejog3446aand thejog3446ais brought into contact with thepatch3410, thesuture limb3412 can thus be fixed relative to thepatch3410 such that thepatch3410 will not drift along thesuture limb3412 after implantation. Thejog3446acan also provide for additional stability during patch installation. Asecond jog stitch3446bcan be formed with thesecond limb3414. The jog stitches3446a,3446bcan be formed in vivo, or alternatively can be formed before thepatch3410 is introduced into the surgical site using patch delivery systems described below. Alternately, the two sutures of the first set ofsutures3412,3414 can be associated with thepatch3410 with different stitches, or no additional stitches. Further, in some instances, a combination of loops and jogs can be used.
• A sixth parameter that can be changed to achieve various patch configurations relates to whether the second set of suture limbs is disposed in lumens formed in the patch, or alternatively, through portions of the patch through which the first set of suture limbs is passed. One illustration of such a configuration is illustrated inFIG. 33D. As shown, the second set ofsuture limbs3416,3418 can be introduced into therespective lumens3407a,3407bof thepatch3410, along with one of thesuture limbs3412,3414 of the first set of suture limbs. This occurs at alocation3409a,3409bthat is lateral to themedial edge3410M of thepatch3410. This configuration of the second set can provide for a further securing of the patch in an anterior-posterior direction. A person skilled in the art will recognize a location at which the second, or first, set of suture limbs is disposed within thepatch3410 can vary without departing from the spirit of the present disclosure.
• A seventh parameter that can be changed to achieve various patch configurations is the inclusion of additional sutures, such as central medial sutures or central lateral sutures, to provide additional securement of the patch at discrete locations from the lumens. For example, as shown inFIG. 33E, one or more central medial inverted mattress stitches3470 can be made in thesoft tissue3430 medial to thepatch3410. In the illustrated embodiment, thestitch3470 is approximately in-line with the first and second mattress stitches3440a,3440b, although other configurations, locations, and number of stitches are possible without departing from the spirit of the present disclosure. The central medialinverted mattress stitch3470 can be generally aligned with a center of thepatch3410 in some instances, such as the illustrate embodiment. The centralmedial stitch3470 can result insuture limbs3472a,3472bextending therefrom. Thesuture limbs3472a,3472bcan be disposed over aproximal face3410pof thesuture patch3410 and secured withsuture anchors3460a,3460b, respectively, according to techniques provided for herein.
• Alternatively, or in addition to the central medialinverted mattress stitch3470, a centrallateral mattress stitch3474 can be pre-loaded onto the patch at a location in the lateral half of the patch. Alternatively, the centrallateral mattress stitch3474 can be formed in thepatch3410 in vivo. The centrallateral mattress stitch3474 can be generally aligned with a center of thepatch3410. Like the medial inverted mattress stitch, a number of different configurations, locations, and number of stitches are possible, and in the illustrated embodiment theinverted mattress stitch3474 results insuture limbs3476a,3476bextending from thepatch3410. In the illustrated embodiment, thesuture limbs3476a,3746bare disposed over theproximal face3410pof thesuture patch3410 and are additionally secured insuture anchors3460a,3460b. Both the central medial stitch and lateral central stitch can provide for additional compression of the patch against the soft tissue to aid in healing. While thepatch3410 illustrated inFIG. 33E illustrates both a central medial mattress stitch and a central lateral mattress stitch in the same embodiment, in other embodiments only one or neither may be provided. Further, other locations for additional stitches are also possible without departing from the spirit of the present disclosure.
• An eighth parameter that can be changed to achieve various patch configurations is a location of the first set of suture limbs with respect to the second set of suture limbs. More particularly, this parameter relates to whether the limbs of the first set of suture limbs are disposed inside or outside of the limbs of the second set of suture limbs, where outside represents being further from the centrallongitudinal axis3410c. In the embodiments illustrated inFIGS. 33A and 33D, the first set of suture limbs is disposed inside of the second set of suture limbs, while in the embodiments illustrated inFIGS. 33B, 33C, and 33E, the first set of suture limbs is disposed outside of the second set of suture limbs. More particularly with respect toFIG. 33D, the first set of suture limbs is disposed inside the second set of suture limbs until they converge at thelocation3409a, at which point they are substantially aligned. Thus, the orientation of the first set of suture limbs with respect to the second set of suture limbs can change between the medial andlateral edges3410M,3410L, including having some portion that is inside the other and some portion that is outside of the other. Further, a person skilled in the art will recognize that not each limb of the set of limbs needs to be disposed in the same respect, meaning that some limbs of the first set of limbs can be disposed inside of one or more limbs of the second set of limbs, and likewise some limbs of the first set of limbs can be disposed outside of one or more limbs of the second set of limbs in the same patch configuration.
• Notably, most any of the aforementioned parameters or variables can be mixed and matched in one or more patch configurations without departing from the spirit of the present disclosure. Accordingly, there are many different configurations that can result from the present disclosure. The term “most any” is used because a person skilled in the art will recognize that, depending on the value of some of these parameters, some of the other parameters may not be adjustable, and a person skilled in the art will recognize as such in view of the present disclosures and the skilled person's knowledge.FIGS. 33A-33E represent a small sampling of possible configurations intended to illustrate various configurations based on the eight parameters identified in the present disclosure. Each of the illustrated configurations can be used in conjunction with various procedures.FIG. 33C represents one particularly useful configuration in that it provides for the stability provided for by theloops3444a,3444b, provides for a configuration in which the first set of limbs are disposed approximately straight through thepatch3410 to provide additional securement of theedges3410S,3410T. Further, the configuration is additionally particular useful because the second set of limbs are disposed approximately straight (as opposed to crossed in an “X” configuration or shape) over thepatch3410 to aid in the medialization of the patch and ease of tensioning of the limbs, the four limbs decrease the likelihood of undesirable “cheese-wiring,” and the configuration does not include additional stitches or the like, making it easier and/or quicker to perform than some options that include additional stitches.
• Still another exemplary embodiment of a tissue augmentation construct2410 having a patch or scaffold configuration is illustrated inFIGS. 34A and 34B. As shown, thepatch2410 has a rectangular-shaped body having generally rounded corners. Alternatively, thepatch2410 can have any shape, for example circular. Thepatch2410 can be disposed on or otherwise associated withsutures2412,2416. As shown, thepatch2410 has a length L_P″ that is substantially equal to a width W_P″, and it also has a thickness T_P″.
• A person skilled in the art will recognize that the dimensions of the length L_P″, the width W_P″, thickness T_P″ of theaugmentation patch2410 can depend on a variety of factors, including but not limited to the size of the filament with which it is to be associated, the anatomy of the patient, and the type of procedure being performed. The exemplary, non-limiting dimensions provided above for thepatch2210 can also be applicable to the size of thepatch2410, with the understanding that other dimensions are possible. Likewise, a number of techniques known to those skilled in the art can be used to associate theaugmentation patch2410 with thesutures2412,2416. Nevertheless,FIGS. 34A and 34B illustrate one exemplary method for usingsuture threaders2406a,2406bto associate thepatch2410 with thesutures2412,2416.
• As shown inFIGS. 34A and 34B, thesutures limbs2412,2416 are threaded to thepatch2410 atmedial locations2411a,2411bof the patch, respectively, to secure thesutures2412,2416 relative to thepatch2410 in a pre-installation configuration. In the illustrated embodiment themedial locations2411a,2411bare located approximately midway between opposingsides2410a,2410bof thepatch2410, although other locations are possible. Thesutures2412 and2416 can be stitched, or otherwise threaded, onto thepatch2410 such that twosuture limbs2412a,2412band2416a,2416b, respectively, extend from a proximal surface of thepatch2410. Thesuture limb2412aand2416acan each have a first portion that includes a hollow self-lockingmechanism2470aand2470bhaving alumen2472aand2472bextending therethrough. In the illustrated embodiment the self-lockingmechanisms2470a,2740bare finger-trap-like configurations, although other self-locking mechanisms provided for herein or otherwise known to those skilled in the art in view of the present disclosures can also be used.
• The self-lockingmechanisms2470aand2470bcan each have a length that is less than the distance extending between theside2410aof thepatch2410 and therespective stitches2411aand2411b. Thesuture threaders2406a,2406bcan be inserted through the respective self-lockingmechanisms2470a,2470bsuch that aproximal handle portion2408a,2408bis located proximate to the respectivemedial locations2411a,2411b, and the distal suture-receiving ends2409a,2409bare located more proximate to theside2410athan theside2410b. Thesuture limbs2412a,2416acan have respectiveleading tails2413a,2413bextending from the self-lockingmechanisms2470a,2740b. As shown, the leadingtail2413a,2413bof eachsuture2412,2416 can be threaded from aproximal side2410pto thedistal side2410dof thepatch2410, at a location that is more proximate to theside2410athan theside2410b. Further, as illustrated, thesuture limbs2412b,2416bare threaded from theproximal side2410pto thedistal side2410dof thepatch2410, at a location that is more proximate to theside2410bthan theside2410a, thereby forming trailing tails. A person skilled in the art will recognize a variety of other ways by which thepatch2410 can be associated with thesutures2412,2416 without departing from the spirit of the present disclosure.
• FIGS. 34C-34J provide for one exemplary method of installing thetissue augmentation patch2410 to help secure a piece ofsoft tissue2430, e.g., rotator cuff, tobone2450 using asingle row repair2432. Like the many other methods provided for herein, thepatch2410 and related techniques can also be used in other types of repairs, such as double row repairs. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation patch have been prepared according to accepted surgical techniques including those provided for herein, as shown inFIG. 34C, thetissue2430 can be fixed to thebone2450 using asuture2403 coupled to an anchor2404 that inserted into thebone2450. While onesuture2403 and one anchor2404 are shown, a plurality can be used in order to effectively fix thetissue2430 relative to thebone2450. Further, in the illustrated embodiment only the components associated with one of the threaders and sutures is visible because of the point of view illustrated, but a person skilled in the art will understand that the other threader and suture can be operated in a similar manner. Reference may be made to both components, even though only one is visible, for ease of description.
• Once thetissue2430 has been fixated to thebone2450, the leadingtails2413a,2413bcan be stitched into the tissue, medial of the repair, as shown inFIG. 34D. In the illustrated embodiment, the leadingtails2413a,2413bare threaded into, and back out of, thetissue2430 using, for example, amattress stitch2442a. As shown inFIG. 34E, the leadingtail2413acan be coupled to the suture-receivingend2409aof thesuture threader2406a, and thesuture threader2406acan be subsequently operated as provided for in the present disclosure to advance the leadingtail2413ainto thelumen2472aof the self-lockingmechanism2470a. A similar action can be taken with respect to the leadingtail2413bso that it becomes disposed in thelumen2472bof the self-lockingmechanism2470b, although, as indicated above, this is not visible in the point of view illustrated. After distal ends of thetails2413a,2413bhave been passed through the respective self-lockingmechanisms2470a,2740bsuch that the distal ends are visible and able to be grabbed by a user, as shown inFIG. 34F, thethreaders2406a,2406bcan be disconnected from thetails2413a,2413band disposed of and/or prepared for future use. In the illustrated embodiment, the self-lockingmechanisms2470a,2470bcan operate such that the respective leadingtails2413a,2413bcan only advance in one direction, or can optionally be selectively lockable.
• As shown inFIG. 34G, the operator can apply a force F_Pto the leadingtails2413a,2413bto advance thepatch2410 towards themattress stitch2442a. More specifically, as the force F_Pis applied to the leadingtail2413a, a loop2415adefined by the self-lockingmechanism2470ais collapsed, as illustrated by the resulting configuration inFIG. 34H. A similar result occurs when the force F_Pis applied to the leadingtail2413b.
• Thepatch2410 is an installed location, as shown inFIG. 34H, when therepair2432 has been covered by thepatch2410. More particularly, the illustrated installed configuration shows that theside2410aof thepatch2410 is proximate to themattress stitch2442a. As a result, when theside2410bof thepatch2410 is coupled to a location in the body, thepatch2410 is able to bend over as shown and more securely protect and integrate with thetissue2430. This is because thepatch2410 can stretch to provide for a tighter fit. Thepatch2410, in combination with thesutures2412,2416, operate together as a single continuous suture or belt, which can better share the load than using multiple stitches. A person skilled in the art will recognize that other lengths of thepatch2410, other locations for themedial stitches2411a,2411b, and other locations for a distal terminal end of the self-lockingmechanisms2472a,2742b, among other factors, can be adjusted to achieve other installed configurations in accordance with the present disclosures. Alternatively, thepatch2410 can be located medial to therepair2432, or any other location that is desired for a given procedure.
• Any number of techniques for securing a location of theside2410bof thepatch2410 within the body can be used, including those provided for herein. In the illustrated embodiment, after thepatch2410 has been installed onto thetissue2430, as shown inFIGS. 34I and 34J, the leadingtail2413aand the trailingtail2412bare coupled to theanchor2460aand the leadingtail2413band trailingtail2416bare coupled to theanchor2460b. The leadingtails2413a,2413band the trailingtails2412b,2416bcan then be tightened to secure thepatch2410 against the repair before theanchors2460a,2460bare fully fixed in thebone2450. Once thepatch2410 is secured within the body, thepatch2410 does not generally flex much or move so that way thepatch2410 can protect and heal in manners described throughout the present application with respect to augmentation constructs generally. Alternatively, the trailingtails2412b,2416bcan both be secured to thepatch2410 at a location proximate theanchors2406a,2406bto allow for the patch to stretch over the tissue.
• In an alternative method, the leadingtail2413band the trailingtail2412acan be coupled to theanchor2460aand the leadingtail2413aand the trailingtail2416bcan be coupled to theanchor2460b, as shown inFIG. 34K. Such a configuration provides for a crossed pattern that can provide benefits as described above when discussing crossed patterns. In yet a further alternative embodiment, the leadingtails2413a,2413bcan be cut proximate to where they exit the self-lockingmechanisms2470a,2470b, respectively, such that only the trailingtails2412b,2416bare secured into theanchors2406a,2406b, respectively. This is because in certain self-locking mechanism configurations, such as the finger-trap-like configuration illustrated, allows the trailingtails2412b,2416bto carry the load. A person skilled in the art, in view of the present disclosures, will further recognize that various suture sizes and configurations can be adjusted in view of theflexible patch2410 to help share the load.
• Thetissue augmentation patch2410 can be manufactured using a number of different techniques which have been previously discussed above with regards to tissue augmentation constructs, including but not limited to thetissue augmentation patches2210,2310. Further, thepatch2410 can be made from any of the materials provided for above with respect to thepatches2210,2310, including materials that promote healing and tissue growth, for example collagen. As a result, while the patient is healing from the procedure, the patch can remodel into tendon-like tissue and integrate with the underlying native tissue. The additional coverage of tendon like tissue across the soft tissue can increase the strength of the soft tissue to bone connection and may prevent further injury.
• Another exemplary embodiment of a tissue augmentation construct2510 having a patch or scaffold configuration is illustrated inFIGS. 35A-35D. Thepatch2510 has a shape and size similar to that of thepatch2410, and can be disposed on or otherwise associated withsutures2512a,2512b,2516a,2516b. A number of techniques provided for throughout the present disclosure can be used to couple or otherwise associate thepatch2510 with thesutures2512a,2512b,2516a,2516b. As shown inFIG. 35A, thesutures2512a,2516aare threaded to thepatch2510 atmedial locations2511a,2511bof the patch, respectively, to secure thesutures2512a,2516arelative to thepatch2510. Themedial locations2511a,2511b, can be similar to the comparablemedial locations2411a,2411bof thepatch2410, and thus can lead to some of the same benefits described above. Thesutures2512a,2516acan be stitched or otherwise fixed onto thepatch2510 such that thesutures2512a,2516aextend from a proximal surface of thepatch2510. First portions of thesutures2512a,2516acan each include a hollow self-lockingmechanism2570a,2570bhaving alumen2572a,2572bextending therethrough. In the illustrated embodiment the self-lockingmechanisms2570a,2570bare finger-trap-like configurations, although other self-locking mechanisms provided for herein or otherwise known to those skilled in the art in view of the present disclosures can also be used.
• The self-lockingmechanisms2570a,2570bcan have lengths that are less than the distance extending between theside2510aof thepatch2510 and the respectivemedial locations2511a,2511b.Suture threader2506a,2506bcan be inserted throughrespective lumens2572a,2572bof the self-lockingmechanisms2570a,2572band can be configured in a similar manner as thesuture threaders2406a,2406bdescribed above. Thesutures2512a,2516acan includeleading tails2513a,2513bwhich, as shown, can extend respectively from the self-lockingmechanisms2570a,2570b. As shown inFIGS. 35A and 35B, the leadingtails2513a,2513bare threaded from aproximal side2510pto thedistal side2510dof thepatch2510, at a location that is proximate to theside2510aof thepatch2510.
• Unlike the previous embodiment of the tissue augmentation construct2410 in which the trailing tails were part of the filament used to form the self-locking mechanisms and the leading tails, trailing tails of thetissue augmentation construct2510 are separate filaments that are not part of the filaments used to form the self-lockingmechanisms2570a,2570bor the leadingtails2513a,2513b. As shown, thesuture2512bis a trailing tail that includes a mattress stitch at a location that is proximate to theside2510bof thepatch2510, and thesuture2516bis a trailing tail that includes a simple stitch at a location that is also proximate to theside2510b. More particularly, each of the trailingtails2512band2516bpass from aproximal side2510pof thepatch2510 to adistal side2510dof thepatch2510. By providing separate leading and trailing tails, a user can have additional control over theconstruct2510 since the tails can operate independently. It can, for example, enhance the stretching of theconstruct2510 that occurs at eitherend2510a,2510b. Notably, this embodiment illustrates some non-limiting ways by which sutures can be associated with tissue augmentation constructs, and thus in other embodiments both trailingtails2512b,2516bcan use similar stitches. A person skilled in the art will recognize a variety of other ways by which thepatch2510 can be associated with thesutures2512a,2512b,2516a,2516bwithout departing from the spirit of the present disclosure.
• The method of installing thetissue augmentation patch2510, which is illustrated inFIGS. 35C and 35D by way of an installed configuration, can be similar to the method described above with respect to thepatch2410, and the installed configuration is illustrated without including the steps leading thereto. As shown, themedial locations2511a,2511bof thepatch2510 are proximate to an edge of thetissue2530, and theedge2510bis disposed proximate toanchors2560a,2560bby way of the trailingtails2512b,2516bbeing coupled and tightened thereto. Alternatively, thepatch2510 can be located medial to the repair, or any other location that is required for the procedure.
• Yet another exemplary embodiment of a tissue augmentation construct2610 having a patch or scaffold configuration is illustrated inFIGS. 36A-36I. Thepatch2610 has a shape and size similar to that of thepatches2410 and2510, and can be disposed on or otherwise associated withsutures2612,2616. A number of techniques provided for throughout the present disclosure can be used to couple or otherwise associate thepatch2610 with thesutures2612,2616. As shown inFIG. 36A, thesutures limbs2612,2616 are threaded into the patch atmedial locations2611a,2611bof thepatch2610, respectively, to secure thesutures2612,2616 relative to thepatch2610. Themedial locations2611a,2611b, can be similar to the comparablemedial locations2411a,2411bof thepatch2410, and thus can lead to some of the same benefits described above.
• Thesuture2612 can be stitched or otherwise fixed onto thepatch2610 such that twosuture limbs2612a,2612bextend from aproximal surface2610pof thepatch2610. Each of thesuture limbs2612aand2612bcan have a first portion that includes a hollow self-lockingmechanism2670a,2670bhaving alumen2672a,2672bextending therethrough, respectively. In the illustrated embodiment the self-lockingmechanisms2670a,2670bare finger-trap-like configurations, although other self-locking mechanisms provided for herein or otherwise known to those skilled in the art in view of the present disclosures can also be used.
• The self-lockingmechanisms2670a,2670bcan have lengths that are less than the distance extending between therespective sides2610a,2610bof thepatch2610, as shown, and themedial location2611a.Suture threaders2606a,2606bcan be inserted throughrespective lumens2672a,2672bof the self-lockingmechanisms2670a,2672band can be configured in a similar manner as thesuture threaders2406a,2406bdescribed above. Thesuture limbs2612a,2612bcan includeleading tails2613a,2613bwhich, as shown, can extend respectively from the self-lockingmechanisms2670a,2670b. As shown inFIGS. 36A and 36B, the leadingtails2613a,2613bare threaded from theproximal side2610pto thedistal side2610dof thepatch2610, at location that are proximate to therespective sides2610a,2610bof thepatch2610.
• Thesuture2616 can be stitched or otherwise fixed onto thepatch2610 in substantially the same manner as thesuture2612, and thus includes self-lockingmechanisms2670c,2670dassociated withsuture limbs2616a,2616b, with the self-lockingmechanisms2670c,2670dhaving leadingtails2613c,2613dextending therefrom, respectively. As shown inFIG. 36A, the resultingpatch2610 can be symmetrical with regards to a first axis A₁and a second axis A₂. A person skilled in the art will recognize a variety of other ways by which thepatch2610 can be associated with thesutures2612,2616 without departing from the spirit of the present disclosure.
• FIGS. 36C-36I provide for one exemplary method of installing thetissue augmentation patch2610 to help secure a piece ofsoft tissue2630, e.g., rotator cuff, tobone2650 using a single row repair. Like the many other methods provided for herein, thepatch2610 and related techniques can also be used in other types of repairs, such as double row repairs. Once the surgeon has access to the surgical site and the tissue, bone, and tissue augmentation patch have been prepared according to accepted surgical techniques including those provided for herein, as shown inFIG. 36C, thetissue2630 can be fixed to thebone2650 using asuture2603 coupled to ananchor2604 that inserted into thebone2650. While onesuture2603 and oneanchor2604 are shown, a plurality can be used in order to effectively fix thetissue2630 relative to thebone2650. Further, in the illustrated embodiment only the components associated with one of the sutures is visible because of the point of view illustrated, but a person skilled in the art will understand that the other suture and related components can be operated in a similar manner.
• Once thetissue2630 has been fixated to thebone2630, the leadingtails2613a,2613ccan be stitched into the tissue, medial of the repair, as shown inFIG. 36C. As shown, the leadingtail2613ais threaded into, and back out of, thetissue2630 using, for example, amattress stitch2642a. The leadingtail2613acan then be coupled to the distal suture-receivingend2609aof thesuture threader2606a, and thesuture threader2606acan be subsequently operated as provided for in the present disclosure to advance the leadingtail2613ainto thelumen2672aof the self-lockingmechanism2670a, thereby forming aloop2615a. After the distal end of thetail2613ahas been passed through the self-lockingmechanisms2670asuch that the distal end is visible and able to be grabbed by a user, as shown inFIG. 36D, thethreader2606acan be disconnected from thetail2613aand disposed of and/or prepared for future use. In the illustrated embodiment, the self-lockingmechanism2670acan operate such that the leadingtail2613acan only advance in one direction, or can optionally be selectively lockable. The leadingtail2613ccan be similarly threaded through the self-locking mechanism2670c, in conjunction with thethreader2606c.
• Ananchor2660acan be inserted into thebone2650, laterally offset from therepair anchor2604, having acollapsible loop2662aand atensioning tail2664aassociated therewith. Thetensioning tail2664acan be used to collapse thecollapsible loop2662atowards theanchor2660a. The leadingtail2613ccan be similarly threaded through the self-locking mechanism2670c, and asecond lateral anchor2660b(FIG. 36I) and collapsible loop (not visible) can be similarly installed into thebone2650.
• As shown inFIGS. 36E and 36F, the trailingtail2613bcan be looped through thecollapsible loop2662aand then coupled to the distal suture-receivingend2609bof thesuture threader2606b. Thesuture threader2606bcan be subsequently operated as provided for in the present disclosure to advance the trailingtail2613binto thelumen2672bof the self-lockingmechanism2670b, thereby forming aloop2615b. After the distal end of thetail2613bhas been passed through the self-lockingmechanisms2670bsuch that the distal end is visible and able to be grabbed by a user, as shown inFIG. 36F, thethreader2606bcan be disconnected from thetail2613band disposed of and/or prepared for future use. In the illustrated embodiment, the self-lockingmechanism2670bcan operate such that the leadingtail2613bcan only advance in one direction, or can optionally be selectively lockable. The leadingtail2613dcan be similarly threaded through the self-lockingmechanism2670d, in conjunction with thethreader2606d.
• As shown inFIG. 36G, thecollapsible loop2662acan be collapsed towards theanchor2660a, thereby bringing a portion of theloop2615btowardsanchor2660a. The trailingtail2613dcan be similarly looped through a collapsible loop (not shown) associated with theanchor2660bto bring a portion of that collapsible loop towards theanchor2660b, as seen at least inFIG. 36I.
• As shown inFIG. 36H, the operator can apply a force F_Pto the leadingtail2613a, trailingtail2613b, leadingtail2613c, and trailingtail2613dto advance thepatch2610 towards the repair. Thepatch2610 is in an installed location, shown inFIG. 36H, when the repair has been covered by thepatch2610, similar to the installed configuration described above with respect to thepatch2410, and when slack in the loops2615a-2615dhas been removed. Thus, adjustments to positioning of thepatch2610 and related components can also be achieved in manners similar as described with respect to thepatch2410. After thepatch2610 has been installed onto thetissue2630, as shown inFIGS. 36H and 36I, the excess portion of the tails2613a-2613dthat extend out of the self-locking mechanisms2670a-2670dcan be cut to remove excess material.
• Tissue Augmentation Patch Delivery Tools
• Tools that aid in the delivery and suture management of tissue augmentation constructs can reduce the complexity and time involved with the procedures are also provided for in the present disclosure. Some such tools, including threaders and theinstallation tool200′, are provided for above. The disclosure in this section focuses on some delivery tools that can be used in conjunction with patches or scaffolds, although a person skilled in the art will recognize how many different constructs provided for herein can be used in conjunction with various delivery tools and systems provided for herein without departing from the spirit of the present disclosure. In other words, just because the disclosures provided below primarily illustrate delivery tools used in conjunction with patches or scaffolds, other tissue augmentation constructs can also be used in conjunction with delivery tools of the nature provided for, even if some modifications by a skilled person would be desirable and/or necessary to accommodate the different configurations. Such modifications would be possible in view of the present disclosures and knowledge of the skilled person. The tools for delivering scaffolds as illustrated include construct management folding cards (FIGS. 37A-37E), construct management release cartridges (FIGS. 38A-38E), construct management deconstructable boxes (FIGS. 39A-39F), construct management boxes configured to mount to a cannula (FIG. 40), and construct delivery insertion tools (FIGS. 41A-41E and 42A-42C).
• One exemplary embodiment of a construct management folding card is illustrated inFIGS. 37A-37E. As shown inFIG. 37A, a constructmanagement folding card3520 can secure or otherwise hold a patch orscaffold3510 having threaders3509a-3509ddisposed in the patch for implantation at a surgical site. Thecard3520 can include a bottompatch securing portion3524 and atop flap3522. Thetop flap3522 can be folded over, as shown along a crease3526, thebottom portion3524 to protect thepatch3510 and threaders3509a-3509dduring transport. While in the illustrated embodiment thecard3520 utilizes a folding configuration with a crease to protect the patch, many other configurations of a card that protects the patch can be used without departing from the spirit of the present disclosure, including embodiments provided for herein or otherwise derivable therefrom. For example, thebottom portion3524 and thetop flap3522 can be separate pieces that are coupled together using any number of techniques known to those skilled in the art. Thecard3520 can be formed of any suitable material including plastics, cardboard, and metals.
• A plurality of threaders for associating filament with thepatch3510 are also provided. The threaders can include a tab or handle3508a-3508d, a filament3507a-3507dattached therethrough, and a loop3506a-3506dat the end of the filament. For example, a suture limb can be associated with the loop and a user can draw the filament, and therefore the loop and suture limb associated therewith, through the patch by grasping the tab. In some embodiments, the threaders3509a-3509dcan be disposed through thepatch3510 in a manner that enables thesuture limbs3512a,3514ato formloops3540a,3540bat themedial edge3510M of thepatch3510, like theloops3440a,3440billustrated inFIG. 33C. Any number of patch-threader and patch-filament configurations are possible for the construct, and in the illustrated embodiment thefilament3507aof thefirst threader3509ais disposed in thepatch3510 approximately parallel to a firstouter side edge3510aof thepatch3510, and the filament3507bof thesecond threader3510bis disposed in thepatch3510 at an approximately 45 degree angle relative to thefilament3510a. The third andfourth threaders3510c,3510d, and their associatedfilaments3507c,3507d, are disposed proximate the secondouter side edge3510bof the patch in a similar fashion as shown.
• In use, as shown inFIGS. 37B-37E, once the surgeon has access to the surgical site, for example through thecannula3590, and the surgical site has been prepared according to accepted surgical techniques, thesuture limbs3512a,3512b,3514a,3514bcan be brought outside the patient through thecannula3590. Thetop flap3522 of the card can be unfolded to expose thepatch3510 and the suture threaders3509a-3509d. As discussed above, aloop3540acan be formed by first inserting thesuture limb3512athrough thesecond threader3509band pulling the threader in a direction P1 from adistal side3510dto aproximal side3510pof thepatch3510, as shown inFIG. 37B. Thesuture limb3512acan then be disposed through thefirst threader3509aand advanced through a lumen, not shown, from themedial edge3510M of the patch to thelateral edge3510L of the patch in a direction P2, as shown inFIG. 37C.
• As illustrated inFIG. 37D, thetop flap3522 can be removed from thecard3520 and thecard3520 can be turned over to provide access to thethreaders3509c,3509d. In the illustrated embodiment, access is initially limited to the first twothreaders3509a,3509bto prevent a user from unintentionally associating thesuture limb3512awiththreaders3509c,3509d. Alternatively, thecard3520 may not include thetop flap3522 thereby providing access to all of the threaders3509a-3509dat the same time. In the illustrated embodiment, theflap3522 is detached along the crease, for instance by providing a perforation along the crease, although many techniques known to those skilled in the art for separating one portion of a card or paper from another can be used.Suture3514acan be threaded through thepatch3510 usingthreaders3509c,3509dto create asecond loop3540busing the technique provided forsuture3512a. Once thesuture limbs3512a,3514ahave been threaded into thepatch3510, as shown inFIG. 37E, thepatch3510 can be removed from thebottom portion3524 and can be introduced into the surgical site to complete the repair, according to accepted surgical techniques including those provided for herein. Slack insuture limbs3512a,3514acan be created when introducing the patch construct into the surgical site. Thesuture limbs3512a,3512b, and3514a,3514b, respectively, are part of single sutures that can be disposed in the soft tissue with an inverted mattress stitch, not shown. The loop stitches3540a,3540bcan fix therespective suture limbs3512a,3514brelative to the patch. As such, application of force F on one of thesuture limbs3512b,3514aof each pair can remove slack from theother limbs3512a,3514aof the pair as the suture slides through the mattress stitch. Thus, the slack, not shown, can be reduced by applying the force F on the twofree suture limbs3512b,3514bto pull slack out of the surgical site. In alternative embodiments, the threaders3509a-3509dcan be disposed through thepatch3510 in many other configurations, including but not limited to those provided above, to create any of the aforementioned configurations (e.g., forming a jog instead of a loop). Further, although apatch3510 is shown, any construct can be advantageously used with the construct management cards of the nature described with respect toFIGS. 37A-37E. The constructmanagement folding card3520 can be disposed after use or reused as provided for herein.
• One exemplary embodiment of a construct management release cartridge is illustrated inFIGS. 38A-38D. As shown, a constructmanagement release cartridge3620 can secure or otherwise hold a patch orscaffold3610 havingthreaders3609a,3609bdisposed in the patch for implantation at a surgical site. Thecartridge3620 can releasably secure thepatch3610 and its associatedthreaders3609a,3609bby using arelease mechanism3660 to expose thepatch3610. Therelease mechanism3660 can advantageously prevent theconstruct3610 from being released before the user is ready to insert theconstruct3610. In the illustrated embodiment, thecartridge3620 includes twothreaders3609a3609bconfigured tothread suture limbs3612a,3612bthrough the construct. For example, asingle threader3609acan be used to thread asingle suture limb3612ainto the patch. Thethreader3609acan have a3608ahandle disposed on afirst side3620aof thecartridge3620 and asuture receiving end3607aexiting on athird side3620c. The intermediate portion of thethreader3609acan be disposed in atrack3624aof thecartridge3620. Thetrack3624acan define a path for forming a loop when asuture limb3612ais disposed through thepatch3610, similar to the loop ofFIG. 33C. Alternatively, a single threader, or more than two threaders, can be disposed through thepatch3610. As shown in the illustrated embodiment, the second threader3610bcan similarly have ahandle3608bdisposed at thefirst side3620aof the cartridge and asuture receiving end3607bexiting on afourth side3620d. Thesecond threader3609bcan be disposed in asecond track3624b.
• Therelease mechanism3660 can be disposed proximate asecond side3620b, which can be opposite a first side3610a. Therelease mechanism3660 can generally include arelease button3662 and retainingfeatures3664a,3664b. As illustrated inFIG. 38C, therelease button3662 and retaining features3664 can be a unitary piece that can be actuated to move in a proximal/distal direction D. In one embodiment, as shown inFIG. 38C, the retaining features3664a,3664bcan be J or hook shaped to retain the threader or suture limb in the cartridge. For example, thedistal end3665a,3665bof theretaining feature3664a,3664bcan, in a locked configuration, be disposed against thedistal side3620dof the cartridge such that thesuture limb3612ais retained by thecartridge3620. Upon actuation of therelease button3662, the distal ends3665a,3665bof the retaining features3664a,3664bcan be offset from thedistal side3620dto permit the suture limbs to be released. Therelease button3662 can be disposed on the proximal side3620pof the cartridge and the retaining features3664a,3664bcan be disposed on thedistal side3620dof the cartridge. The retaining features3664a,3644bcan retain thepatch3610 in the cartridge by holding thethreaders3609a,3609b, orsuture limbs3612a,3612b, until the operator is ready to install thepatch3610. Analternative release mechanism3660′ is illustrated inFIG. 38D and can include apivotable release button3662′ that can flex in a direction D′ to release asuture limb3612a, shown in phantom. Thecartridge3620′ can include a proximal portion3620p′ that has an approximately 10 degree draft to aid guiding asuture3612a′ during release. Thealternative cartridge3620′ can further include anoverhang3666′ that can prevent accidental release.
• In use, first andsecond suture limbs3612a,3612bcan be threaded onto thepatch3610 by application of a force on thehandles3608a,3608bof therespective threaders3609a,3609busing techniques provided for throughout the present disclosure. Once the first andsecond suture limbs3612a,3612bhave been threaded into thepatch3610, for instance, by forming loops (not shown), thelimbs3612a,3612bcan be retained in thecartridge3620 by the retaining features3664a,3664b. A user can then activate therelease button3662 to disengage the retaining features3664a,3664bto free the loops, and thus thepatch3610, from thecartridge3620. Thepatch3610 andsuture limbs3612a,3612bcan then be advanced into the surgical site and the soft tissue repair can be completed using techniques provided for throughout the present disclosure or otherwise known to those skilled in the art.
• An alternativeconstruct delivery cartridge3720 similar to thecartridge3620 ofFIGS. 38A-38D is illustrated inFIGS. 38E and 38F. Similar to thecartridge3620,cartridge3720 can retain apatch3710 and threaders, as shown twothreaders3709a,3709bdisposed in threadingtracks3724a,3724b. In an alternative to therelease mechanisms3660,3660′, the cartridge consists of abottom portion3720aand a toppatch retaining portion3720b. Once the suture limbs (not shown) are threaded into thepatch3710 using techniques provided for throughout the present disclosure or otherwise known to those skilled in the art in view of the present disclosure, the toppatch retaining portion3720aof the cartridge can be removed from thebottom retaining portion3720bto release thepatch3710 and suture limbs from thecartridge3720, as shown inFIG. 38F. For example, in some embodiments, afinger hold3780 can be disposed on thetop portion3720ato provide a user a means for releasing thetop portion3720afrom thebottom portion3720b. Any number of configurations for attaching one component to another can be used to releasable couple thetop portion3720ato thebottom portion3720b, including but not limited to any number of male-female mating elements. For example, thetop portion3720acan include a retaining lip on a distal surface, not shown, that can retain thebottom portion3720b. Alternatively, thetop portion3720aand thebottom portion3720bcan be releasable coupled via an interference fit. Thepatch3710 and suture limbs can then be advanced into the surgical site and the soft tissue repair can be completed using techniques provided for throughout the present disclosure.
• The threaders provided for with respect to the delivery tools ofFIGS. 37A-38F, as well as provided for elsewhere in the present disclosure, can have a number of different configurations.FIGS. 38G and 38H provide for one, non-limiting exemplary embodiment. As shown, thethreader3809 has ahandle3807 associated with anintermediate portion3810 that includes asuture receiving end3808. Theintermediate portion3810 can be manufactured from a flexible strand of nylon, or other flexible and durable materials. In some instances, theintermediate portion3810 can be formed from a doubled over thread having afirst half3810aand asecond half3810b. The handle portion can have any shape that is ergonomically designed to aid a user in removing thethreader3809 from an associated construct. The handle can include a plurality ofridges3830a-3830cthat can extend across thehandle3807 to provide a user added grip. Alternatively, thehandle3807 can include any number of ridges or other surface features to enhance the grip of a user on the handle. In the illustrated embodiment, thehandle portion3807 has three lumens3804a-3804cextending from afirst side3807ato asecond side3807b. The openings3806a-3806cof the lumens3804a-3804con thesecond side3807bcan be formed in arecess3830, as shown inFIG. 38H. The lumens and openings help allow theintermediate portion3810, and thus thesuture receiving end3808, to be associated with thehandle portion3807, as illustrated. Further, the handle can include anotch3832 formed between the first andsecond lumens3804a,3804bfor retaining theintermediate portion3810.
• To manufacture thethreader3809, thefree end3810fof theintermediate portion3810 can be threaded from thefirst side3807aof thehandle3807 throughfirst lumen3804ato thesecond side3807bof the handle. Theintermediate portion3810 can then be threaded into thesecond lumen3804bfrom thesecond side3807bof the handle thereby creating afirst loop3812a. Thefree end3810fcan be then threaded through thesecond lumen3804bto thefirst side3807aof the handle, into thethird lumen3804c, over thefirst end3807a, through to thesecond side3807bof the handle. Thefree end3810fof the intermediate portion can then be threaded through thefirst loop3812a. Tension can be applied to suture receivingend3808 of theintermediate portion3810 to tighten the portion of theintermediate portion3810 threaded through thehandle3807 until the slack has been removed. When the slack has been removed, thefree end3810fof the intermediate portion can be locked in place in thenotch3832. The portion of theintermediate portion3810 that is disposed on thesecond side3807bof thehandle3807, after the slack has been removed, can be disposed entirely in the recess. Thefirst loop3812aand the locked portion of thefree end3810fcan be disposed in thenotch3830 without the need for any additional knots or retaining features. Advantageously, theintermediate portion3810 of thethreader3809 can easily be replaced due to wear.
• One exemplary embodiment of a constructmanagement deconstructable box3920 is illustrated inFIGS. 39A-39F. Thebox3920 can be configured to secure a construct, such as a patch or scaffold3910, to enable the construct to be easily associated with operative sutures, as shownsutures3912a,3912b,3914a,3914b. Thebox3920 can generally include abase portion3924, a firsttop compartment3922a, a secondtop compartment3922b, and aretaining button3926. Thebox3920 can be configured to hold the patch3910 and one or more threaders within in it, and in the illustrated embodiment thebox3920 has twothreaders3909a,3909bdisposed within it. The patch3910 can be pre-threaded with the first andsecond threaders3909a,3909band twosuture limbs3918a,3918b. The patch3910 can be initially retained in thebox3920 by the first and second top compartments3924a,3924band thepush button3926. The slots3924a,3924bcan be disposed along a top surface of the respective first and secondtop compartments3922a,3922bproximate afirst side3920aof thebox3920. The handles of thethreaders3909a,3909bcan be accessible from thesecond side3920bof the box3020. The twosuture limbs3918a,3918bcan be retained in securingslots3928a,3928bdisposed in the respective first and second top compartments3924a,3924b. Theretaining button3926 can be pushed inward to retain the patch3910 in the box during the threading operation. For example, when thebutton3926 is actuated, the button can be retained in thebottom portion3924. In some embodiments, the retaining button3936 can extend upward past the surfaces of the first and second top compartments in an unengaged configuration, as shown in phantom inFIG. 39A, and the top surface of thebutton3926tcan be flush with the top surfaces of the first andsecond compartments3923a,3923b, as shown inFIG. 39B. A person skilled in the art will recognize that many other configurations of a deconstructable box are possible, and thus although the present disclosure provides for a single base portion, two top compartments, and a push button, any number of base portions, top compartments, and push buttons can be used together to achieve the same results without departing from the spirit of the present disclosure.
• In use, as shown inFIGS. 39B-39F, fouroperative sutures3912a,3912b,3914a,3914bcan exit through a cannula3990 (FIG. 39D) from a surgical repair site. A firstpre-threaded suture3918acan be released from the first slot3929aof the firsttop compartment3922aand secured to a firstoperative suture3912b, for instance using aknot3913a. In one embodiment approximately 40.0 millimeters to 60.0 millimeters of slack can be left in the firstpre-threaded suture3918aafter theknot3913ais tied. The firsttop compartment3922acan then be released from thebase portion3924, as shown inFIG. 39C. Next, for example, a leading side of the first operative suture can then be threaded through acuff feature3911a(FIG. 39F) with the firstpre-threaded suture3918a. The patch3910 can include first andsecond cuffs3911a,3911bthat are fixed to thetop surface3910tof the patch3910 to retainoperative sutures3912b,3914bfor fixing the location of the patch3910 once installed in the surgical site, as shown inFIG. 39F. The secondoperative suture3912acan then be threaded into the patch3910 with thethreader3909ausing techniques provided for throughout the present disclosure, as shown inFIG. 39D. This process can then be completed with the third and fourthoperative sutures3914a,3914band the secondtop compartment3922bremoved, as shown inFIG. 39E, these components operating in a similar fashion as those described in conjunction with the removal of the firsttop compartment3922a. Once theoperative sutures3912a,3912b,3914a,3914bhave been threaded onto therespective cuffs3911a,3911band the patch3910, theretaining button3926 can be released from thebase portion3924 by application of opposing force F2, F3 to sides3926a,3926bof thebutton3926. The patch3910 is thus released from thebox3920, as shown inFIG. 39F. The patch3910 andsuture limbs3912a,3912b,3914a,3914bcan then be advanced into the surgical site and the soft tissue repair can be completed using techniques provided for throughout the present disclosure.
• In alternative embodiments, any number of threaders can be disposed through the constructs of the various construct management cards, cartridges, and boxes to achieve any of the disclosed construct embodiments provided for herein. In a further alternative embodiment, delivery tools like the construct management cards, cartridges, and boxes ofFIGS. 37A-40, as well as other delivery tools provided for herein, can be mounted directly onto a cannula to free a hand of the operator during the suture threading of a construct. For example,FIG. 40 provides aconstruct cartridge4022 having twoconstruct retaining buttons4026a,4026band twothreaders4009a,4009b. The retainingbuttons4026a,4026bcan be depressed to retain a construct disposed therein during a threading operation. The illustratedconstruct cartridge4022 can be directly mounted to theproximal end4090pof thecannula4090 such that the construct disposed therein, not shown, can be threaded by the operative suture limbs while fixed relative to thecannula4090. Thecartridge4022 can be removably associated with the proximal end of thecannula4090 with any known releasable interfaces. Alternatively, any of the delivery tools provided in the present disclosure, including the construct management cards, cartridges, and boxes ofFIGS. 37A-40, can be removably mounted to thecannula4090.
• Additional tools for delivering constructs into a surgical site through a cannula, or other opening, are illustrated inFIGS. 41A-41E. As noted above, tissue augmentation constructs can include patches orscaffolds4110. In some embodiments, apatch4110 can include twosuture limbs4112a,4114aassociated with aproximal end4110pof the patch and twosuture limbs4112b,4114bassociated with adistal end4110d. Alternatively, thepatch4110 can include two suture limbs disposed through respective lumens in the patch, not shown, from theproximal end4110pto thedistal end4110d. In some embodiments, thepatch4110 can include anopening4120, the opening having a construction that includes but is not limited to a hole, slot, or slit disposed proximate thedistal end4110dof the patch. The opening can be configured to receive a delivery tool. For example, atool4130 having ashaft4132 and a distalpatch engaging end4136 can be used in conjunction with theopening4120. In the illustrated embodiment, thetool4130 resembles a femoral aimer. As shown inFIG. 41B, the distalpatch engaging end4136 can include an offsetextension4137 and ashelf4138 at the distal terminal end of thetool4130. In an alternative embodiment shown inFIG. 41C, thetool4130′ can be similar to a Gryphon anchor inserter (available from DePuy Synthes of Raynham, Mass.), and can have anextension4137′ that is substantially axially aligned with a central longitudinal axis A1 theshaft4132′. In a further alternative embodiment, as shown inFIG. 41D, thetool4130″ can have a taperedend4137″ having a maximum diameter that is larger than the diameter of thehole4120 in thepatch4110. A person skilled in the art will recognize many other configurations of tools that can be used in conjunction with patches in view of the present disclosure.
• In use, thepatch4110 can be inserted into the surgical site using thetool4130, or alternative embodiments of such tools provided for herein or otherwise derivable from the present disclosures. Thepatch4110 can be inserteddistal end4110dfirst. The offsetextension4137 can be inserted into thehole4120 of thepatch4110 until theshelf4138 is in contact with a surface of thepatch4110 such that thetool4130 cannot advance through thehole4120. Thetool4130 can then be used to advance thepatch4110 through a cannula or incision site to push thepatch4110 into the surgical site. Thetool4130 can then be disengaged from thepatch4110 and removed from the patient by moving it in the proximal direction. An additional tool may be used to hold the patch in place while thedelivery tool4130 is removed, or alternatively, a location at the surgical site can be used to help hold the patch at the desired location. A person skilled in the art will recognize how a patch can be disconnected from the tool in conjunction with a surgical procedure in view of the present disclosures. Thepatch4110 can then be installed according to techniques provided for herein.
• A further alternative delivery tool, as described adelivery needle tool4230, is illustrated inFIGS. 42A-42C. In contrast to the tools ofFIGS. 41A-41E, thedelivery needle4230 can be actuated to unload, or release, an associatedpatch4210. Thedelivery needle4230 can include anouter sleeve4232 and aretractable needle4234 slidably disposed within theouter sleeve4232. Theouter sleeve4232 can have acentral lumen4233 extending from a proximalmost end4232pto a distalmost end4232dof thesleeve4232 through which theneedle4234 can be slidably disposed. Ahandle portion4236 of theneedle4234 can be proximate theproximal end4232pof thesleeve4232 and aninsertion end4238 of the needle can be proximate thedistal end4232dof thesleeve4232. Theinsertion end4238 of theneedle4234 can have constant diameter, or, as illustrated, can be tapered. Theneedle4234 can be slidably disposed within thesleeve4232 so that theneedle4234 can be retracted proximally within the sleeve such that theinsertion end4238 is entirely received within thelumen4233. Thesleeve4232 can have a diameter D1 that is larger than the diameter D2 of theneedle4234. The diameters D1, D2 of thesleeve4232 and theneedle4234 can depend on a variety of factors, including but not limited to the size of an opening of a patch with which the tool is to be associated, the anatomy of the patient, and the type of procedure being performed.
• In use, thepatch4210 can be inserted into the surgical site using thetool4230. Thepatch4210 can be substantially similar to thepatch4110 and include anopening4220 at adistal end4210dthereof. Thepatch4210 can be inserted through the cannula or incision sitedistal end4210dfirst. Theinsertion end4238 of theneedle4234 can be inserted into thehole4220 of thepatch4210 until thedistal end4232dof theouter sleeve4232 is in contact with a surface of thepatch4210 such that thetool4230 cannot advance through thehole4220, as shown inFIG. 42B. Thetool4230 can be used to advance thepatch4210 through a cannula or incision site to push thepatch4210 into the surgical site. Once thepatch4210 is at the desired location, a user can grasp thehandle4236 of theneedle4232 to retract theinsertion end4238 of theneedle4232 relative to thesleeve4232. Thus, theinsertion end4238 can be removed from thehole4220 until the distalmost end4238dof theinsertion end4238 is disposed in thesleeve4234 such that the tool can be disengaged from thepatch4210 and removed from the patient. Thepatch4210 can then be installed according to techniques provided for herein.
• Tissue Augmentation Construct—Suture Leader
• FIG. 43 provides for another exemplary embodiment of a tissue augmentation construct, as shown asuture leader2701. Asuture leader2701 can be placed on a distal end of asuture2712. The suture leader can have afirst section2704 having a diameter D₁and asecond section2706 having a diameter D₂. As shown, D₁is larger than D₂. The smaller diameter of D₂can allow for thesecond section2706 to be folded in half and more easily pulled through a lumen of a tissue augmentation construct while allowing the operativefirst portion2704 to have the necessary diameter and strength to complete the repair. Thesuture leader2701 can be integral with thesuture2712, or can be an additional end-cap that is installed over a distal-most end or proximal-most end of thesuture2712. Thesuture leader2701 can be used with any of the above mentioned embodiments of tissue augmentation constructs and related methods, other medical procedures, and in applications outside of the medical field.
• One skilled in the art will appreciate further features and advantages of the present disclosure based on the above-described embodiments. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. Further, although the systems, devices, and methods provided for herein are generally directed to surgical techniques, at least some of the systems, devices, and methods can be used in applications outside of the surgical field. All publications and references cited herein are expressly incorporated herein by reference in their entirety.

Claims (22)

What is claimed is:

1. A soft tissue suture repair system, comprising:

a suture filament having a collapsible loop defined by a self-locking mechanism configured to adjust a size of the collapsible loop by moving along a length of the suture filament, the suture filament further having a first tail and a second tail, the first and second tails extending from an opposite side of the self-locking mechanism than the collapsible loop extends from the self-locking mechanism, at least one of the first and second tails being actuable to move the self-locking mechanism along a length of the suture filament to adjust the size of the collapsible loop; and

a tissue augmentation tack coupled to the suture filament, the tissue augmentation tack having a diameter that is at least two times greater than a diameter of the suture filament.

2. The system ofclaim 1, wherein the tissue augmentation tack is coupled to at least one of the first and second tails and disposed on the opposite side of the self-locking mechanism from the collapsible loop.

3. The system ofclaim 1, further comprising a guide having a lumen extending from a proximal end of the guide to a distal end of the guide, the lumen being configured to receive an inserter tool for inserting an anchor coupled to the collapsible loop to a surgical site.

4. The system ofclaim 3, further comprising a slot formed in an outer surface of the guide, the slot extending an entire length of the guide, from the proximal end to the distal end, and the slot being configured to receive the suture filament.

5. The system ofclaim 1, further comprising an anchor coupled to the collapsible loop.

6. The system ofclaim 5, wherein the anchor is a toggle anchor.

7. The system ofclaim 5,

wherein the anchor is a soft anchor formed of a flexible construct, and

wherein the soft anchor is actuable from an unstressed configuration, in which the soft anchor has a first length and a first diameter, to a stressed configuration, in which the soft anchor has a second length that is less than the first length and a second diameter that is greater than the first diameter.

8. The system ofclaim 1, wherein the first tail is actuable to move the self-locking mechanism along a length of the suture filament to adjust the size of the collapsible loop, and a locking knot is formed by part of the second tail to fix a location of the tissue augmentation tack with respect to the suture filament.

9. The system ofclaim 1, wherein the diameter of the tissue augmentation tack is at least three times greater than a diameter of the suture filament.

10. The system ofclaim 1, wherein the tissue augmentation tack comprises at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, and fascia.

11. The system ofclaim 10, wherein the tissue augmentation tack comprises collagen.

12. A surgical method, comprising:

inserting an anchor coupled to a collapsible loop of a surgical filament into bone;

disposing the collapsible loop through tissue adjacent to the bone;

applying tension to a first tail of the surgical filament to collapse the collapsible loop, thereby drawing a tissue augmentation tack coupled to the surgical filament towards the tissue and bone such that the tissue augmentation tack applies a force to the tissue to draw the tissue towards the bone, the tissue augmentation tack having a diameter that is at least two times greater than a diameter of the suture filament; and

locking a location of the tissue augmentation tack with respect to the bone to set the location of the tissue with respect to the bone.

13. The surgical method ofclaim 12, further comprising:

positioning a distal end of a guide adjacent to the tissue,

wherein inserting an anchor coupled to a collapsible loop of a surgical filament into bone further comprises passing the anchor through the guide.

14. The surgical method ofclaim 13, further comprising:

advancing a punch through the guide to form a hole in the tissue,

wherein disposing the collapsible loop through tissue adjacent to the bone further comprises passing the collapsible loop through the hole in the tissue.

15. The surgical method ofclaim 14, further comprising:

advancing the punch through the guide to form a hole in the bone,

wherein inserting an anchor coupled to a collapsible loop of a surgical filament into bone further comprises inserting the anchor into the hole in the bone.

16. The surgical method ofclaim 13, further comprising:

inserting a portion of the collapsible loop into a slot formed in an outer surface of the guide to assist in managing the suture filament during performance of the method.

17. The surgical method ofclaim 13, wherein the guide is removed before applying tension to the first tail of the surgical filament to collapse the collapsible loop.

18. The surgical method ofclaim 12, further comprising toggling the anchor to set a location of the anchor with respect to the bone.

19. The surgical method ofclaim 12, wherein the anchor is a soft anchor formed of a flexible construct, the method further comprising:

actuating the anchor from an unstressed configuration to a stressed configuration to set a location of the anchor with respect to the bone.

20. The method ofclaim 12, wherein the diameter of the tissue augmentation tack is at least three times greater than a diameter of the suture filament.

21. The surgical method ofclaim 12, wherein the tissue augmentation tack comprises at least one of: fabric, plastic, synthetic polymer, natural polymer, collagen, collagen scaffold, reconstituted collagen, biological autograft connective tissue, biological allograft connective tissue, biological xenograft connective tissue, human dermal matrix, porcine dermal matrix, bovine dermal matrix, periosteal tissue, pericardial tissue, and fascia.

22. The surgical method ofclaim 21, wherein the tack comprises collagen.

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