CROSS-REFERENCES TO RELATED APPLICATIONSThe present application is a non-provisional of, and claims the benefit of U.S. Provisional Patent Application Nos. 61/177,602 (Attorney Docket No. 028357-000110US, formerly 020979-003910US), filed May 12, 2009; 61/219,290 (Attorney Docket No. 028357-000200US, formerly 020979-004700US), filed Jun. 22, 2009; 61/263,728 (Attorney Docket No. 028357-000210US, formerly 020979-004710US), filed Nov. 23, 2009; 61/263,751 (Attorney Docket No. 028357-000220US, formerly 020979-004720US), filed Nov. 23, 2009; 61/298,780 (Attorney Docket No. 028357-000230US, formerly 020979-004730US), filed Jan. 27, 2010; and 61/304,352 (Attorney Docket No. 028357-000240US, formerly 020979-004740US), filed Feb. 12, 2010; the entire contents of each of the above listed patent applications is incorporated herein by reference.
The present application is also related to U.S. patent application Ser. Nos. 12/605,065 (Attorney Docket No. 028357-000120US, formerly 020979-003920US), filed Oct. 23, 2009; Ser. No. ______ (Attorney Docket No. 028357-000130), filed concurrently with the present application; and Ser. No. ______ (Attorney Docket No. 028357-000250US), also filed concurrently with the present application; each of which, the entire contents are incorporated herein by reference.
BACKGROUND OF THE INVENTION1. Field of the Invention
The present disclosure relates to medical devices, systems and methods, and more specifically to methods, systems and devices used for knotless suturing of tissue.
Soft tissue such as tendons, ligaments and cartilage are generally attached to bone by small collagenous fibers which are strong, but which nevertheless still can tear due to wear or disease. Examples of musculoskeletal disease include a torn rotator cuff as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint.
Thus, treatment of musculoskeletal disease may involve reattachment of torn ligaments, tendons or other tissue to bone. This may require the placement of devices such as suture anchors within bone. A suture anchor is a device which allows a suture to be attached to tissue such as bone. Suture anchors may include screws or other tubular fasteners which are inserted into the bone and anchored in place. After insertion of the anchor, the tissue to be repaired is captured by a suture, the suture is attached to the anchor (if not already pre-attached), tension is adjusted, and then the suture is often knotted so that the tissue is secured in a desired position.
Most conventional suture anchors require the surgeon to tie knots in the suture to secure the target tissue to the bone after the anchor is placed. Knot tying can be difficult during surgery, particularly if working in a confined space through cannulas or other surgical ports as in arthroscopic surgery. Therefore, it would be desirable to provide knotless suture anchor systems.
Additionally, many surgeons prefer to use polymeric anchors rather than metal ones so that the anchors are compatible with the use of MRI. While polymeric anchors are available, they do not have the knotless suture securing capabilities described above. This may be in part due to challenges of fabricating polymer anchors that provide a reliable cinching mechanism for a knotless anchor at the small scale required for orthopedic procedures. Further, while it is frequently advantageous to fabricate polymeric devices by molding, known knotless anchor designs require multiple moving parts and geometries which are not suitable for molding. Therefore it would be advantageous to provide a knotless anchor with the characteristics described above and which is also suitable to being molded with a polymer as a single integral part or as series of molded components that can be easily assembled together. By single integral part, it is meant that the entire part is formed from a single piece of material or molded as a single piece, without need for fastening, bonding, welding or otherwise interconnecting multiple components together. Examples of this include, but are not limited to, single-piece components that are injection molded, cast, or machined from a single block of material. The word “molded” is intended to encompass materials which are injection molded, blow molded, compression molded, thermoformed, or made using other molding processes known to those of skill in the art, useful for shaping polymers, ceramics, or other formable materials.
Frequently two or more anchors and multiple lengths of suture are required. Using such devices can be time consuming and difficult to undertake in the tight space encountered during endoscopic surgery and sometimes even in conventional open surgery. Recently, knotless suture anchors having suture clamping mechanisms have been developed to eliminate the need to tie knots but they still can be difficult or awkward to use.
Some knotless suture anchors have been devised which allow the suture to be cinched and secured without tying a knot, however these typically rely upon trapping the suture between the anchor and the bone to secure the suture, which means the anchor cannot be fully inserted into the bone until the tissue has been captured and secured tightly. The process of maintaining tension on the suture, keeping the tissue at the desired location and simultaneously inserting the anchor into the bone is difficult. Other knotless anchors rely on the manual actuation of some type of moving part on the anchor to clamp or trap the suture within the anchor, requiring an extra hand that the surgeon may not have available. It would be desirable to allow the anchor to be fully inserted in the bone prior to securing the tissue and to avoid the requirement of extra manipulations to secure the suture.
Thus, it would be desirable to provide improved knotless suture anchors that are easier to use and also that may take up less space during deployment and that are easier to deploy.
In particular, treating musculoskeletal disease in a hip joint can be especially challenging. The hip joint is a deep joint surrounded by a blanket of ligaments and tendons that cover the joint, forming a sealed capsule. The capsule is very tight thereby making it difficult to advance surgical instruments past the capsule into the joint space. Also, because the hip joint is a deep joint, delivery of surgical instruments far into the joint space while still allowing control of the working portions of the instrument from outside the body can be challenging. Additionally, the working space in the joint itself is very small and thus there is little room for repairing the joint, such as when reattaching a torn labrum to the acetabular rim. Moreover, when treating a torn labrum, the suture anchor must be small enough to be inserted into the healthy rim of bone with adequate purchase, and the anchor also must be short enough so that it does not protrude through the bone into the articular surface of the joint (e.g. the acetabulum). Existing anchors may be used to repair the labrum, but are not well-suited to labral repair especially in the hip. First, the reattachment of the labrum to the acetabular rim is most effective if both ends of the suture are attached to the same point in the bone. This provides the most precise and secure apposition of the labrum to the rim. The space available on the acetabular rim is very limited, typically requiring an anchor with a transverse dimension (e.g. diameter) preferably less than 4 mm and no more than about 3.5 mm and therefore many commercially available anchors are too large. Thus, it would be desirable to provide suture anchors that have a small diameter and length.
Additionally, existing knotless anchors are typically designed for use in rotator cuff repair in the shoulder and they are intended for placement in separate holes in the bone. These devices have no mechanism for coupling one anchor to the other within the same hole, cannot be implanted concentrically within the hole, and are too long for stacking within the same hole. Further, many existing knotless anchors are too large for placement on the acetabular rim for labral repair of the hip.
In addition, existing knotless anchors and interconnecting anchors have suture locking mechanisms which have moving parts and other complex designs that are not reliably manufacturable at the small scale required for labral repair anchors. While various types of anchors with suture locking mechanisms have been disclosed, many of these cannot be made in an anchor less than 4 mm, and no more than 3.5 mm in diameter.
Moreover, because of the difficulty of performing labral repairs arthroscopically, it is highly desirable to minimize the manipulations of the suture and anchor that are required intraoperatively. Many existing knotless anchors require the surgeon, after initial anchor placement and capture of the labrum, to thread the free end of the suture through the anchor or a component of the anchor, which is difficult and takes an excessive amount of time. Some anchors further require the surgeon to push the anchor further into bone, or push a locking mechanism on the anchor, or perform some other manipulation of the anchor in order to lock the suture. These manipulations add difficulty and time to arthroscopic labral repair that would be desirably avoided.
Therefore, it would be desirable to provide improved knotless suture anchors that are ideally suited to arthroscopic procedures, and in particular labral repair in the hip. The anchors would preferably be adapted for placement in a single hole in the bone, extremely simple in design with few or no moving parts, manufacturable at very small scale (e.g. diameter less than 4 mm, and preferably no more than 3.5 mm), and require no manipulation of the suture or the anchor itself in order to operate the suture locking mechanism. The anchors should further require no intraoperative threading of the suture ends or other manipulation of the suture either before or after initial anchor placement.
Thus, there is a need for improved devices, systems and methods which overcome some of the aforementioned challenges. At least some of these objectives will be met by the inventions described hereinbelow.
2. Description of the Background Art
Patents disclosing suture anchoring devices and related technologies include U.S. Pat. Nos. 7,566,339; 7,390,329; 7,309,337; 7,144,415; 7,083,638; 6,986,781; 6,855,157; 6,770,076; 6,767,037; 6,656,183; 6,652,561; 6,066,160; 6,045,574; 5,810,848; 5,728,136; 5,702,397; 5,683,419; 5,647,874; 5,630,824; 5,601,557; 5,584,835; 5,569,306; 5,520,700; 5,486,197; 5,464,427; 5,417,691; and 5,383,905. Patent publications disclosing such devices include U.S. Patent Publication Nos. 2009/0069845 and 2008/0188854 and PCT Publication No. 2008/054814.
BRIEF SUMMARY OF THE INVENTIONThe present invention provides devices, systems and method for knotless suturing of tissue. Exemplary procedures where knotless suturing may be advantageous include repair of torn rotator cuffs, as well as a torn labrum in the acetabular rim of a hip joint or the glenoid rim in a shoulder joint. The invention relates to suture anchors for anchoring sutures to bone, and more specifically provides a suture anchor which eliminates the need for knotting the suture and which is suited to being a molded polymer construction. The anchors will find particular utility in hip and shoulder arthroscopy, e.g. labral reattachment and similar procedures.
In a first aspect of the present invention, a knotless suture anchoring system comprises a first anchor positionable in tissue and having a longitudinal axis. The system also has a cinching mechanism coupled to the first anchor. The cinching mechanism comprises a body having first and second transverse apertures spaced apart along the longitudinal axis and separated by a bar. A length of suture is threaded through the first and second apertures so as to form a loop around the bar. The suture has first and second extremities extending respectively from the first and second apertures on the same side of the body, and the first and second extremities are generally parallel to and lie over one another such that the second extremity is sandwiched between the first extremity and the body. Exerting tension on the first extremity compresses the second extremity against the body to prevent movement of the suture relative to the body. Also, exerting tension on the second extremity allows the suture to move longitudinally relative to the body.
The suture may comprise a flat cross-sectional profile, a round cross-sectional profile, or any other profile. The anchor has a proximal end, a distal end, and the longitudinal axis extends therebetween. The first and second apertures may extend through the body in a direction transverse to the longitudinal axis. The central channel may be aligned with the longitudinal axis, and the channel may have an opening at the proximal end. At least one of the first and second extremities of suture may extend through the opening. The cinching mechanism may be positioned in a central channel of the anchor. The apertures may be disposed along the body in a single line substantially parallel with the longitudinal axis. The body may comprise a plate and the first and second apertures comprise slots extending through the plate. The plate may be oriented generally parallel to the longitudinal axis. The plate may be disposed in a central channel of the anchor.
The body may have a face against which the second extremity is compressed, and the bar may be laterally offset from the face. The first aperture may intersect the face so as to define a corner which engages the second extremity. The corner may have an edge which locks the second extremity when the first extremity is tensioned. The corner may define an angle of no more than about 90 degrees. The face may comprise one or more features to induce friction with the second extremity when the first extremity is tensioned.
The body may comprise a barrel disposed in an aperture in a sidewall of the anchor transverse to the longitudinal axis of the anchor. The barrel may be rotatably disposed in the sidewall aperture, and the rotatable barrel may have a locked position and an unlocked position. The unlocked position may allow the suture to move, and the locked position may constrain movement of the suture. The apertures may extend through the barrel parallel to a first axis, and in the unlocked position, the first and second extremities may extend from the apertures substantially parallel to the first axis. In the locked position, the first and second extremities extend from the apertures in a direction transverse to the first axis.
The cinching mechanism may be a single molded part, and may be integral with the first anchor. The cinching mechanism and the first anchor may be a single molded part. The cinching mechanism may be on a separate member that is configured to be attached to the first anchor at a surgical site. The cinching mechanism may be coupled to a second anchor adapted for positioning in tissue and which may be coupled to the first anchor. The cinching mechanism may require no movement of parts relative to the first anchor to prevent the suture from moving when the first extremity is tensioned.
The first anchor may have an outer diameter which is less than 4 mm and no more than about 3.5 mm along its entire length. The system may further comprise a second anchor that is positionable in the tissue. One of the two anchors may be positionable concentrically in the other of the two anchors, or one of the two anchors may be positioned end to end with the other of the two anchors.
In another aspect of the present invention, a knotless suture anchoring system comprises a first anchor component having a longitudinal axis and a first cinching mechanism. A second anchor component is initially detached from the first anchor component, and at least one of the first and second anchor components are adapted for placement directly into bone or other tissue and comprise a retention feature on an exterior surface thereof for retaining the first or second anchor component in the bone or tissue. The system also has a coupling mechanism for coupling the second anchor component to the first anchor component, and a length of suture at least partially disposed in the first cinching mechanism. The suture has a free end, and the first cinching mechanism allows the suture to pass through the first cinching mechanism in a first direction when the free end is tensioned and constrains movement of the suture through the first cinching mechanism in a second direction opposite the first direction.
The second anchor component may be received within a cavity in the first anchor component. The first anchor component may be received within a cavity in the second anchor component. The first anchor component may be coupled end-to-end with the second anchor component. The suture may have a second end coupled to the second anchor component. The first cinching mechanism may have no parts movable relative to the first anchor component. The system may further comprise a second cinching mechanism coupled to the second anchor component. The suture may have a second end that is coupled to the second cinching mechanism. The second anchor component may have a suture retention structure for retaining a second end of the suture therein. The first anchor component and the first cinching mechanism may be an integral molded construction.
In another aspect of the present invention, a knotless suture anchoring system comprises a first anchor having a proximal end and a distal end, and being positionable in tissue. A second anchor also has a proximal end and a distal end, and a first cinching mechanism is coupled to either the first anchor or the second anchor. A coupling element is attached to one or both of the first and second anchors and is adapted to couple the first and the second anchors together end-to-end. A length of suture is coupled to either the first anchor or the second anchor. The suture has a free end and is at least partially disposed in the first cinching mechanism. The first cinching mechanism is adapted to allow the suture to be tensioned by pulling the free end so that the suture passes through the first cinching mechanism in a first direction while movement of the suture through the first cinching mechanism in a second direction opposite the first direction is constrained.
The coupling element may comprise a threaded post, and the first anchor may be threadably engaged with the second anchor. The coupling element may comprise a post having a plurality of barbs disposed thereon, or the coupling element may comprise a compression fitting. The suture may be fixed to the first anchor and the cinching mechanism may be on the second anchor. Each of the first and second anchors may be placed in tissue separately from the other of the first and second anchors.
In still another aspect of the present invention, a method for re-joining damaged tissue with substrate tissue comprises providing a suture coupled with a first anchor and a second anchor, and positioning the first anchor in the substrate tissue. The method also includes capturing the damaged tissue with the suture, and positioning the second anchor in the substrate tissue. The second anchor is axially aligned end-to-end with the first anchor. Adjusting the length of the suture apposes the damaged tissue with the substrate tissue.
The substrate tissue may comprise bone and the step of positioning the first anchor in the substrate tissue may comprise drilling a hole in the bone followed by positioning the first anchor therein. The step of positioning the first anchor may comprise advancing the first anchor from an elongate shaft of a delivery instrument. Capturing the damaged tissue may comprise at least partially encircling the damaged tissue with the suture. Capturing may also comprise passing at least one of the suture anchors through a penetration in the damaged tissue. Positioning the second anchor may comprise coupling the first anchor with the second anchor. Coupling the first and second anchors may comprise interconnecting a proximal region of the first anchor with a distal region of the second anchor. Coupling may also comprise engaging a plurality of threads or ribs on a proximal end of the first anchor with the second anchor. Adjusting the length of the suture may comprise pulling the suture through a cinching mechanism disposed in either the first or the second anchor. The cinching mechanism may be adapted to allow the suture to move in a first direction, while the suture is constrained from moving in a second direction opposite the first direction.
In another aspect of the present invention, a method for anchoring suture to substrate tissue comprises drilling a first hole into the substrate tissue, and placing a suture anchor into the first hole. The suture anchor is coupled to a first extremity of a suture. The method also includes capturing damaged tissue with the suture. The damaged tissue obstructs visualization of the first hole, so transmitting light through the damaged tissue allows visualization of the first hole through the tissue. A second extremity of the suture is then coupled to the first anchor.
The second extremity of the suture may be coupled to an anchor component and coupling the second extremity may comprise coupling the anchor component to the first anchor. The anchor component may be inserted concentrically in the first anchor, or the anchor component may be coupled end-to-end with the first anchor. At least one of the first anchor and the anchor component may have a cinching mechanism which allows the suture to move in a first direction and constrains the suture from moving in a second direction opposite the first direction. The method may comprise tightening the suture by pulling it through the cinching mechanism. The first anchor may be placed by means of a delivery instrument to which the first anchor is releasably coupled. The light may be transmitted from a light emission device coupled to the delivery instrument. The substrate tissue may comprise an acetabular or glenoid rim and the damaged tissue may comprise a torn labrum.
In another aspect of the present invention, a method for fabricating a suture anchor comprises molding the suture anchor from a polymer. The suture anchor may be of a unitary construction without moving parts and may have a cinching mechanism adapted to allow a suture to pass therethrough in a first direction while movement of the suture in a second direction opposite the first direction is constrained.
In yet another aspect of the present invention, a knotless suture anchoring system comprises a first anchor having a proximal end, a distal end, a central channel extending therebetween, and positionable in tissue. A tissue piercing needle is positionable in the central channel, and a first cinching mechanism is coupled to either the first anchor or the tissue piercing needle. A coupling element is attached to the first anchor or the tissue piercing needle. The coupling element is adapted to couple the first anchor and the tissue piercing needle together when the tissue piercing needle is positioned in the central channel. A length of suture is coupled to the first anchor and the tissue piercing needle. The suture has a free end and is at least partially disposed in the first cinching mechanism. The first cinching mechanism is adapted to allow the suture to be tensioned by pulling the free end so that the suture passes through the first cinching mechanism in a first direction while movement of the suture through the first cinching mechanism in a second direction opposite the first direction is constrained.
The suture may be tied to the first anchor and the first cinching mechanism may be coupled to the tissue piercing needle. The coupling element may comprise a snap fit between the tissue piercing element and the first anchor. The distal end of the first anchor may comprise a plurality of slits parallel with a longitudinal axis of the first anchor. The slits may form a plurality of deflectable arms in the anchor. An outer surface of the first anchor may comprise a plurality of barbs. The tissue piercing needle may comprise a central channel that is substantially parallel with a longitudinal axis of the needle. The suture may be fixedly attached to the tissue piercing needle, and the first cinching mechanism may be coupled with the first anchor.
In another aspect of the present invention, a method for re-joining damaged tissue with a substrate tissue comprises providing a suture anchor system having an anchor, a tissue piercing needle, and a suture coupled to the anchor and the needle. The anchor is positioned in the substrate tissue, and the damaged tissue is pierced with the needle. The suture is passed through the damaged tissue, and the needle is coupled with the anchor. Suture length is then adjusted so that the damaged tissue is apposed with the substrate tissue.
The substrate tissue may comprise bone and the step of positioning the first anchor may comprise drilling a hole in the bone followed by positioning of the first anchor therein. The step of positioning the first anchor may comprise advancing the first anchor from an elongate shaft of a delivery instrument. The method may further comprise at least partially encircling the damaged tissue with the suture, and the step of adjusting the length may comprise pulling the suture through a cinching mechanism disposed in either the first anchor or the tissue piercing needle. The cinching mechanism may be adapted to allow the suture to move in a first direction, while the suture is constrained from moving in a second direction opposite the first direction. The damaged tissue may comprise a torn labrum. The coupling step may comprise positioning the tissue piercing needle in a central channel of the first anchor.
These and other embodiments are described in further detail in the following description related to the appended drawing figures.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 illustrates basic anatomy of the hip.
FIG. 2 illustrates a top view of the hip.
FIGS. 3-4 illustrate an exemplary method of reattaching a torn labrum to the acetabular rim.
FIGS. 5A-5C illustrate dimensional constraints of a suture anchor used in the hip joint.
FIGS. 6A-6D illustrate an exemplary method of placing suture anchors into a hip joint.
FIG. 7 illustrates suture anchors positioned end-to-end.
FIGS. 8-16 illustrate exemplary suture anchor configurations.
FIGS. 17A-17D illustrate an exemplary suture anchor.
FIG. 18 illustrates another exemplary suture anchor.
FIGS. 19-20 illustrate exemplary embodiments of suture anchor coupling mechanisms.
FIGS. 21A-21B illustrate an exemplary embodiment of a cinching mechanism.
FIGS. 22A-22B illustrate another exemplary embodiment of a cinching mechanism.
FIG. 23 illustrates another exemplary embodiment of a suture anchor.
FIGS. 24A-24B illustrate still another exemplary embodiment of a suture anchor.
FIGS. 25A-25B illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 26A-26C illustrate yet another exemplary embodiment of a cinching mechanism.
FIGS. 27A-27F illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 28A-28C illustrate an exemplary embodiment of a cinching mechanism.
FIGS. 29A-29C illustrate still another exemplary embodiment of a cinching mechanism.
FIGS. 30A-30B illustrate yet another exemplary embodiment of a cinching mechanism.
FIGS. 31A-31B illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 32A-32C illustrate another exemplary embodiment of a cinching mechanism.
FIG. 33 illustrates another exemplary embodiment of a cinching mechanism.
FIGS. 34A-34B illustrate another exemplary embodiment of a cinching mechanism.
FIG. 35 illustrates another exemplary embodiment of a cinching mechanism.
FIGS. 36A-36B illustrate an exemplary embodiment of a cinching mechanism.
FIGS. 37A-37B illustrate an exemplary embodiment of a cinching mechanism.
FIGS. 38A-38B illustrate an exemplary embodiment of a cinching mechanism.
FIGS. 39-48 illustrate other exemplary embodiments of a cinching mechanism.
FIGS. 49A-49C illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 50A-50C illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 51A-51C illustrate another exemplary embodiment of a cinching mechanism.
FIGS. 52A-52B illustrate an exemplary embodiment of a cinching mechanism.
FIG. 53 illustrates obstruction of a pre-drilled hole by tissue.
FIG. 54 illustrates an exemplary method of visualizing a pre-drilled hole.
FIG. 55 illustrates a suture anchor delivery instrument.
FIGS. 56A-56B illustrate an exemplary delivery instrument.
FIG. 57 illustrates an exemplary delivery instrument.
FIGS. 58A-58H illustrate an exemplary method of suture anchor delivery.
FIGS. 59A-59D illustrate an exemplary method of suture anchor delivery.
FIGS. 60A-60B illustrate an exemplary delivery instrument.
FIG. 61A-61C illustrate an exemplary delivery instrument.
FIGS. 62A-62B illustrate an exemplary delivery instrument.
FIG. 63 illustrates an exemplary delivery instrument.
FIGS. 64A-64H illustrate an exemplary method of suture anchor delivery.
FIGS. 65A-65H illustrate an exemplary method of suture anchor delivery.
FIGS. 66-69 illustrate exemplary embodiments of suture anchor delivery.
FIGS. 70A-70B illustrate exemplary embodiments of suture anchor delivery.
FIG. 71 illustrates an exemplary embodiment of suture anchor delivery.
DETAILED DESCRIPTION OF THE INVENTIONSeveral exemplary embodiments of knotless suture anchors, methods of use and delivery instruments are illustrated and described in the attached figures.
Anatomy:
Exemplary use of the devices, systems and methods of the present invention will be discussed primarily in terms of treatment of a hip joint. However, one of skill in the art will appreciate that other tissues may be re-attached to a base tissue or another substrate in other areas of the body including joints such as the shoulder joint, the ankle, wrist and other joints. Other areas may also be treated with the devices, systems and methods disclosed herein. Thus, the exemplary usage described herein is not intended to be limiting.FIG. 1 illustrates the basic anatomy of a hip joint. InFIG. 1 the hip joint is formed between the head of the femur FH and the acetabulum A, a concave surface of the pelvis. A blanket of ligaments cover the joint forming a capsule C. Additionally the acetabular labrum L, a fibrocartilaginous lip, surrounds the head of the femur, deepens the joint pocket and increases the surface area of contact. The ligamentum teres LT is a ligament attached to a depression in the acetabulum (the acetabular notch or fossa) and a depression on the femoral head (the fovea of the head).FIG. 2 is a top view of a hip joint highlighting the labrum L.
The labrum L can tear or separate from the acetabular rim due to wear or disease and this can result in pain as well as loss of joint mobility.FIG. 3 illustrates a tornlabrum32. Surgeons typically use suture and suture anchors to reattach the labrum to the acetabular rim. The surgeon often wraps a free end of the suture around the torn labrum and then the free end is threaded through a suture anchor. The anchor is inserted into bone and the suture length and/or tension is adjusted.FIG. 4 illustrates a torn labrum after it has been reattached to the substrate acetabulum. Asuture anchor42 with asuture44 coupled thereto has been inserted into the acetabulum A thereby fixing one end of thesuture44 to the bone. Thesuture44 is looped around the tornlabrum32 in order to capture the damaged tissue. The other end of the suture is also attached to the anchor and suture length has been adjusted in order to draw the labrum toward the acetabulum, where it is held until it heals and reattaches. Suture anchors are typically used instead of screws, pins, rivets or other fasteners due to the limited working space within the joint.
Referring now toFIGS. 5A-5C, the size of the suture anchor can be very important depending on the treatment zone. For example, when placing asuture anchor54 into theacetabular rim56 to repair the labrum L, the anchor width ordiameter54acannot exceed thewidth52 of theacetabular rim56. Moreover, as shown inFIGS. 5A-5B, theanchor width54amust be small enough relative to the width of theacetabular rim56 so that adequate purchase is obtained without compromising strength of therim56. Thus, in most anchor embodiments described below, the suture anchor width (transverse to the anchor's longitudinal axis), or outer diameter if the anchor has a round profile, is preferably less than about 4 mm and no more than about 3.5 mm. Additionally, length of the anchor can also be critical. InFIG. 5B, theanchor54 is placed substantially orthogonally into the acetabular rim and thus the anchor may be as long as necessary to obtain adequate purchase in the bone without risk of extending into the joint socket. However, it may be difficult to insert the anchor orthogonally into the acetabular rim due to the angle of approach, the narrow width of the rim, or for other reasons. In such cases, the anchor may be placed at a non-perpendicular angle relative to the rim surface, or it may be placed into a lateral facet of the acetabulum. In such cases, if the anchor is either too long or the angle is too great as shown inFIG. 5C, the anchor may pass entirely through the bone and exit into the joint itself, here the acetabular socket A, potentially damaging the cartilage and interfering with joint motion. Thus, when repairing a torn labrum in an acetabular or glenoid rim, the anchor has a diameter usually less than 5 mm, preferably less than 4 mm, and more preferably 3.5 mm or less. The length must be long enough to gain adequate purchase in the bone while also being short enough to avoid penetration into the articular surface, preferably being at least about 5 mm and less than or equal to about 14 mm in length.
FIGS. 6A-6D illustrate an exemplary system and method for reattaching a torn labrum to the acetabular rim. The suture anchor system includes anouter anchor62 and aninner anchor66. A length ofsuture64 having afree end68 is coupled to both of theanchors62,66. Preferably suture64 is pre-threaded in bothanchors62,66 such that no threading of the suture through the anchors is required during the procedure, before or after placement of either anchor. The pair ofanchors62,66 include acoupling mechanism63a,63bthat allow the two anchors to interlock with one another when theinner anchor66 is inserted into theouter anchor62. In this embodiment, theinner anchor66 is inserted concentrically into an inner cavity in theouter anchor62, while in other embodiments described below, the anchors may be coupled together axially in a stacked relationship. InFIG. 6A, the torn labrum L is shown separated from the acetabular rim R of a hip joint having an acetabulum A. Theouter anchor62 is inserted into the acetabular rim R inFIG. 6B, either by placing the anchor into a pre-drilled hole or by directly driving the anchor into the bone. Thesuture64 is then looped around the torn labrum L as shown inFIG. 6C and then theinner anchor66 is inserted into theouter anchor62 where thecoupling mechanism63a,63block the two anchors together as shown inFIG. 6D. Thesuture68 may then be tightened by pulling the free end which advances the suture through a cinching mechanism (not illustrated) in either the inner or outer anchor to tension the suture and draw the torn labrum into apposition with the acetabular rim R. The cinching mechanism allows the suture to be tensioned when pulled in one direction and constrains movement of the suture in the opposite direction. Once the appropriate tension has been achieved, the free end of the suture and any excess suture may be severed and removed from the treatment site. Additional details related to this method, the suture anchors and cinching mechanism may be found in U.S. patent application Ser. No. 12/605,065 (Attorney Docket No. 028357-000120US, formerly 020979-003920) and U.S. patent application Ser. No. ______ (Attorney Docket No. 028357-000130US, formerly 020979-003910US), the entire contents of which are incorporated herein by reference.
Suture Anchor Configurations:
Any of the suture anchors described herein may be fabricated from metals such as stainless steel, nitinol, titanium, etc., ceramics, and other biocompatible materials. However, in preferred embodiments, the anchors are made from MRI (magnetic resonance imaging) compatible polymers such as PEEK (polyetherether ketone) or carbon reinforced PEEK. Dense, hard polymers are preferred so that the anchors will be non-resilient and do not deform when implanted. Preferred embodiments of anchors displace the bone or other substrate tissue when implanted.
In other embodiments of suture systems, the anchor may include more than one suture anchor positioned in a single hole. For example, an approach for the deployment of suture anchors in an axially stacked arrangement in the same hole is illustrated inFIG. 7. A pair of suture anchors72,74 and a length ofsuture78 having afree end80 are used to reattach a torn labrum L to the acetabular rim R. In this exemplary embodiment, bothanchors72,74 are placed end-to-end in a singlepre-drilled hole76 or they may be directly driven into the acetabularrim R. Suture78 is coupled to thedistal-most anchor72 with aknot75 or using another fastening method (e.g. crimping, bonding, etc.) and the length of suture encircles the labrum L and passes through theproximal-most anchor74. The proximal-most anchor includes a cinching mechanism (not shown) that allows thefree end80 of thesuture78 to be pulled and tensioned in one direction while constraining movement of the suture in the opposite direction. By placing the two anchors end-to-end, both anchors may have maximum diameter within the constraints of the target anatomical location which allows the cinching mechanism size to also be maximized. Moreover, this configuration also minimizes the number of holes that must be drilled into the bone during the procedure. Another advantage of this configuration is that a portion of thesuture78 is pinched between an outer surface of theproximal-most anchor74 and the inner wall of thehole76. Not only does this secure the suture in position, but allows a gross adjustment of the suture length or tension by pulling the end of thesuture78 to draw the repaired tissue toward the bone, followed by a fine adjustment of suture length and tension by pulling the opposite end of the suture through the cinching mechanism. Additional details on cinching mechanisms which may be used in these anchors are described below, as well as in Provisional and Non-Provisional Patent Applications previously incorporated herein by reference. The suture anchors may also be placed in separate holes in the bone if desired.
Other exemplary configurations are shown inFIGS. 8-16. For example,FIG. 8 schematically illustrates a two-part suture anchor system having ananchor5402 and aninsert5410 coupled together with a suture S. Theanchor5402 generally has a cylindrical shapedbody5406 and apointed tip5404 that is adapted to penetrate into bone. Acentral channel5408 is substantially parallel to the longitudinal axis of thecylindrical body5406. Theinsert5410 also is generally cylindrically shaped and is concentrically positionable in thecentral channel5408 such that thedistal end5416 of theinsert5410 bottoms out in thecentral channel5408. Theinsert5410 may be sized such that it is press fit into thecentral channel5408 or it may have a locking mechanism, such as a detent mechanism, snap fit, threads, or other mechanical locking mechanism to lock theinsert5410 with theanchor5402. Theinsert5410 also has acinching mechanism5412 that allows the suture to be pulled in one direction for adjustment and tightening, while constraining movement of the suture in the opposite direction. The cinching mechanism may be any of the cinching mechanisms disclosed herein. The suture S has one end attached to the anchor with aknot5418 or by other techniques known to those skilled in the art and the suture also passes through thecinching mechanism5412 and afree end5414 extends from the insert. Thefree end5414 may be pulled to tighten the suture.
FIG. 9 schematically illustrates another anchor system configuration similar to that ofFIG. 8, with the major difference being that the cinching mechanism is a part of the anchor instead of the insert. InFIG. 9, theanchor5502 generally has a cylindrical shapedbody5506 and apointed tip5504 that can penetrate into bone. Theanchor5502 also has acentral channel5508 and acinching mechanism5512. The cinching mechanism may take the form of any of the cinching mechanisms described herein. Theinsert5510 is also generally cylindrically shaped and is positionable in thecentral channel5508 where it may be locked in place using any of the features described herein. Thedistal end5516 of theinsert5510 in this embodiment has a flat planar face, although in other embodiments it may be pointed as will be seen below. A suture S is coupled to both theanchor5502 and theinsert5510. One end of the suture S is tied in aknot5518 or otherwise secured to theinsert5510 and the suture passes through thecinching mechanism5512 of theanchor5502. Afree end5514 extends from theanchor5502 and may be pulled in one direction to tighten the suture.
FIG. 10 schematically illustrates still another anchor system having ananchor5602, a suture S, and aneedle insert5610. Theanchor5602 has a generally cylindrical shapedbody5606 with acentral channel5608 and apointed tip5604 adapted to penetrate into bone. Acinching mechanism5612 that generally takes the form of any of the cinching mechanisms disclosed herein is included in theanchor5602. Theneedle insert5610 also has a cylindrically shaped body and a distaltissue penetrating tip5616 for passing through tissue. A suture S is coupled to both theneedle insert5610 and theanchor5602. One end of the suture S is fixed to theneedle insert5610 with aknot5618 or other technique and the suture S passes through thecinching mechanism5612. Afree end5614 extends from thecinching mechanism5602 and may be pulled through the cinching mechanism in one direction to tighten the suture S. The cinching mechanism constrains movement of the suture therethrough in the opposite direction.
FIG. 11 schematically illustrates yet another anchor system having twoanchors5702,5710. Thefirst anchor5702 has a generally cylindrical shapedbody5706 and apointed tip5704 for penetrating into bone. Thesecond anchor5710 similarly has a cylindrically shapedbody5712 and apointed tip5714 for penetrating into bone. The second anchor may be positioned in the same or a different location than the first anchor. Thesecond anchor5710 also includes acinching mechanism5716 that allows the suture S to be advanced in one direction and constrained in the opposite direction. A suture S is coupled to bothanchors5702,5710. One end of the suture S is fixed to thefirst anchor5702 with aknot5708 or with other techniques known to those skilled in art, and the suture S passes through thecinching mechanism5716 in thesecond anchor5710. Afree end5718 of the suture S extends from the cinching mechanism and may be pulled to adjust suture length extending between theanchors5702,5710.
FIG. 12 illustrates another anchor system having twoanchors5802,5812. In this embodiment, bothanchors5802,5812 include cinchingmechanisms5810,5818. Thefirst anchor5802 has a generally cylindrically shapedbody5806, a pointeddistal tip5804 for penetrating tissue such as bone and acinching mechanism5810. The second anchor5812 similarly has a cylindrically shapedbody5816, apointed tip5814 for penetrating bone or other tissue, and acinching mechanism5818. The second anchor may be positioned in the same location or a different location than the first anchor. A length of suture S is coupled to bothanchors5802,5812. The suture passes through both cinchingmechanisms5810,5818, and has a firstfree end5822 that extends from thefirst anchor5802, and a secondfree end5820 that extends from the second anchor5812. Thus, in this exemplary embodiment, either or bothfree ends5820,5822 may be pulled in order to adjust the length of the suture extending between the anchors.
FIG. 13 schematically illustrates another anchor system having twoanchors5902,5912. Thefirst anchor5902 includes a generally cylindrically shapedhousing5906, a pointeddistal tip5904 for penetrating into bone and acentral channel5908. Thesecond anchor5912 also includes a generally cylindrically shaped body5914, a pointeddistal tip5916 for penetrating bone, and acinching mechanism5918. Thesecond anchor5912 may be positioned directly into bone or it may be positioned concentrically in thecentral channel5908 of thefirst anchor5902 and locked in place using any of the locking mechanisms described herein or known in the art. A length of suture S is coupled to bothanchors5902,5912. One end of the suture S is fixed to thefirst anchor5902 with aknot5910 or by other methods known in the art. The suture S passes through thecinching mechanism5918 in thesecond anchor5912 and afree end5920 extends from thesecond anchor5912 and may be pulled in one direction to adjust the suture length between the two anchors. The cinching mechanism prevents the suture from moving in the opposite direction.
FIG. 14 schematically illustrates another anchor system having two stackedanchors6002,6012. Thefirst anchor6002 has a generally cylindrically shapedbody6006, apointed tip6004 for penetrating bone and acentral channel6010 that is generally parallel with the longitudinal axis of thefirst anchor6002. Thesecond anchor6012 also includes a generally cylindrically shapedbody6014 and acinching mechanism6018. Thecylindrical body6014 has a taperedshoulder6022 near the distal end of theanchor6012 and a reduced diameterdistal region6016 that is positionable and lockable in thecentral channel6010 ofanchor6002. A suture S is coupled to bothanchors6002,6012. One end of the suture S is fixed to thefirst anchor6002 with aknot6008 or by other techniques. The suture passes through thecinching mechanism6018 and afree end6020 extends therefrom.
FIG. 15 schematically illustrates another anchor system having ananchor6102 and aneedle insert6112. Theanchor6102 generally takes the same form as other anchors disclosed herein and includes a cylindrically shapedbody6106, a pointeddistal tip6104 for penetrating tissue such as bone, and acentral channel6110 that is substantially parallel to the longitudinal axis of theanchor6102. Theneedle insert6112 includes a cylindrically shapedbody6114, acinching mechanism6118, and a pointeddistal tip6116 that can penetrate tissue or bone. Theneedle insert6112 is positionable and lockable in the central channel of theanchor6102. A suture S is coupled to both theanchor6102 and theneedle insert6112. One end of the suture S is attached to theanchor6102 with aknot6108 or by other attachment means known in the art. The suture also passes through thecinching mechanism6118 and afree end6120 of the suture S extends from theneedle insert6112 and may be pulled through the cinching mechanism to tighten the suture, while movement of the suture in the opposite direction is constrained. In this exemplary embodiment, the cinching mechanism may take the form of any of the embodiment disclosed herein.
FIG. 16 schematically illustrates still another anchor system, this time with asingle anchor6202. Theanchor6202 includes a generally cylindrically shapedbody6206, acinching mechanism6208, and a pointeddistal tip6204 for penetrating tissue such as bone. One end of a suture S is fixed to theanchor6202 with aknot6212 or by other means and forms aloop region6214 before passing through thecinching mechanism6208. Afree end6210 of the suture S extends from theanchor6202 and may be pulled to adjust the suture. In use, the suture at least partially encircles tissue to be captured and then theanchor6202 passes through theloop6214 and is then anchored into bone or other tissue. The suture can then be adjusted by pulling thefree end6210.
FIGS. 17A-17D illustrate another embodiment of a suture anchor system having an anchor and a needle.FIGS. 17A-17B are perspective views of the system rotated into different positions.FIG. 17C is a perspective view of the system when the anchor is coupled to the needle andFIG. 17D is a cross-sectional view ofFIG. 17C taken along its longitudinal axis. The anchor system includes ananchor6502 having a cylindrical shapedbody6504 and a plurality of barbs orscallops6506 along the outer surface of thebody6504 to help the anchor remain positioned in tissue such as bone. Thedistal portion6510 of the anchor has a flat end and a plurality oflongitudinal slits6508 that allow thedistal portion6510 to expand and contract as the needle is inserted into the anchor. Theproximal end6520 of theanchor6502 is also flat and has acentral channel6526 extending all the way through theanchor6502. Thechannel6526 is substantially parallel to the longitudinal axis of the anchor. Achannel6524 extends through a side wall of the anchor substantially parallel to the longitudinal axis of the anchor and intersects with apassage6522 that extends transversely through the anchor side wall (best seen inFIG. 17B). A suture may be fed through these passages and tied to the anchor.
Theneedle6512 includes a pointedtip6514 that is adapted to pierce tissue and also has ashoulder6518 that helps the needle snap into engagement with the anchor when the needle is concentrically positioned in the anchor. Theneedle6512 also includes acylindrical body6512aand theproximal end6528 of theneedle6512 is flat and has acentral channel6530 extending into the needle. A central region of the needle includes acinching mechanism6516 which includes twoapertures6516a,6516b(best seen inFIG. 17D) for receiving suture (not illustrated). This embodiment of cinching mechanism generally operates in the same manner as described with respect toFIGS. 21A-21B described below. One of skill in the art will of course appreciate that any of the cinching mechanisms disclosed herein may also be used.
In use, theanchor6502 is positioned in bone and the needle is used to pierce through and pass a suture through damaged tissue. The needle is then coupled with the anchor and the suture is tensioned by pulling it through the cinching mechanism. This will be more thoroughly described below.
In some embodiments, a portion of the anchoring system includes a piercing needle for capturing the damaged tissue by passing the suture therethrough.FIG. 18 illustrates another embodiment of an anchor system and needle. Theanchor6602 has a generally cylindrical shapedbody6604 withbarbs6608 along the outer surface and atissue piercing tip6606. Theanchor6602 includes any of the cinching mechanisms described herein and has acentral passage6616 for receiving thetissue piercing needle6610. A length of suture S having afree end6612 is fixed to theneedle6614 by crimping, bonding, knotting or by other methods. The suture passes into the cinching mechanism (not illustrated) in theanchor6602 and thefree end6612 exits the anchor. In use, theanchor6602 is positioned in bone and the suture S at least partially captures the tissue to be repaired. Theneedle6610 is then pierced through the tissue and the suture is also passed through the tissue. The needle is then inserted concentrically into thecentral channel6616 of theanchor6602 and locked into position. The suture S is then adjusted by pulling on thefree end6612 of the suture. In preferred embodiments, the needle diameter ranges from about 1.0 mm to about 2.2 mm. Needle length may range from about 2 mm to about 13 mm. The needle may have a straight tip or the tip may be curved or angled. An angled needle may range from 20 to 60 degrees. Using a needle to pass through the tissue may help retain the natural shape of the tissue thereby helping it to reattach and heal more quickly than if the tissue were deformed by tightening the suture around the tissue.
In anchoring systems having two or more suture anchors, it may be advantageous to attach the two anchors directly together. This minimizes the possibility that the anchors will become dislodged. For example, inFIG. 19, two anchors are stacked together in the same hole and joined with one another. A pair ofanchors82,84 are coupled together with asuture86 having afree end86a. Acoupling element83 extends from the proximal end of thedistal anchor82 and allows the two anchors to be joined together. One end of thesuture86 is fixed to oneanchor82 with aknot88 or other fastening methods may be used, and thisanchor82 may be placed into the bone before the other anchor84. Once theanchor82 is positioned into a pre-drilled hole in the bone or driven directly into the bone, the target tissue is captured by wrapping the second anchor around it or placing the second anchor through a penetration through the target tissue. Second anchor84 is preferably placed into the same hole asfirst anchor82, but may be configured for placement in a separate hole if desired. The second anchor84 is advanced in the hole until its distal end butts up against the proximal end of thefirst anchor82 and thecoupling element83 joins the two anchors together. Thecoupling element83 may be a threaded rod that allows the two anchors to be screwed together, or thecoupling element83 may be a compression coupling with ribs or other features to enhance friction that is press fit into a corresponding bore (not shown) in the second anchor84. Couplingelement83 has arelief feature83awhich allows two opposing halves of the relief feature to flex radially inward toward each other to facilitate insertion in the bore in the distal end of proximal anchor84. One of skill in the art will appreciate that other coupling mechanisms, such as a ratchet, detent, snap fit or other mechanisms may be used to join the two anchors together. Once the two anchors are coupled together, thefree end86aof the suture may be pulled to advance thesuture86 through a cinching mechanism (not shown) in the second anchor84 thereby allowing adjustment of suture length and tension. The second anchor84 may have any of the cinching mechanisms disclosed in this specification.
FIG. 20 illustrates another exemplary embodiment of a pair of anchors that couple together in an end-to-end configuration. Theanchors1002,1004 are coupled together with a length ofsuture1018 having afree end1018a. Eachanchor1002,1004 has a tapereddistal end1006,1008 that helps align the anchor into a hole drilled into the bone or provides a penetrating tip that may be driven directly into bone. Acoupling element1010 is attached to anchor1002 and may be a threaded rod or a compression coupling that engages with the corresponding engagement feature (e.g. a threaded female receptacle or a channel)1012 onanchor1004. Additionally,anchor1004 includes a series ofrelief slots1014 that allow the distal extremity of the anchor to radially expand and contract as thecoupling element1010 is advanced into engagement withanchor1004. Thus, as the coupling element is initially advanced intoaperture1012, the relief slots allow theanchor1004 to expand and receive thecoupling element1010. Once the coupling element has been inserted intoanchor1004, the anchor collapses back to its natural shape, locking thecoupling element1010 in place and providing an end-to-end or stacked pair of suture anchors. While this embodiment illustrates themale coupling element1010 onanchor1004, one will of course appreciate that it could easily be placed onanchor1004. In use, once the anchors have been placed into the bone, the free end of thesuture1018amay be pulled, pulling thesuture1018 through a cinching mechanism (not shown) inanchor1004. The cinching mechanism may be any of the mechanisms disclosed in this specification or incorporated by reference.
One-Way Cinching Mechanisms:
FIGS. 21A-21B illustrate a first exemplary embodiment of a suture cinching mechanism that may be used in any of the suture anchors disclosed herein. Thesuture anchor1202 may have a taperedcylindrical tip1204 to facilitate positioning in a hole in bone or to provide a tip that may be advanced to penetrate directly into the bone. Acentral wall1216 extends proximally fromtip1204 such that itsface1218 is generally parallel to thelongitudinal axis1222 ofanchor1202.Wall1216 has anupper aperture1208 and alower aperture1210 extending transversely (indicated by phantom line1224) throughwall1216 and separated by abar1220, thus forming abuckle1206. Afirst extremity1214 of suture S enters thelower aperture1210 from one side of the buckle, passes through thelower aperture1210 and exits the aperture. The suture S then enters theupper aperture1208 from the opposite side of the buckle and exits the aperture such that asecond extremity1212 of the suture S is positioned under thefirst extremity1214 of the suture, thus forming a loop aroundbar1220. It will be appreciated that the terms “enter” and “exit” are relative and therefore a suture that enters an aperture may also be referred to as exiting the aperture. Similarly, a suture that is described as exiting an aperture may be referred to as entering the aperture. This applies throughout this specification unless indicated to the contrary. When positioned in a hole in bone or other tissue,anchor1202 is inserted far enough so thatwall1216 is fully recessed inside the hole. This constrains thefirst extremity1214 andsecond extremity1212 of suture S within a space lying between thewall1216 and the surrounding bone or tissue, thereby maintaining them in an orientation in which the first and second extremities are generally parallel (+/−30 degrees) to thelongitudinal axis1222 ofanchor1202 and theface1218 ofwall1216. This orientation of the first and second extremities of suture S help to ensure the proper functioning of the cinching mechanism. If thesecond extremity1212 of suture S is pulled the suture will advance through the buckle. However, when thefirst extremity1214 of the suture is pulled, it compressessecond extremity1212 against theunderlying face1218 ofwall1216, thereby preventing the suture from advancing through the buckle. Preferably, thelower aperture1210 forms acorner1226 where it intersects with the face ofbar1220, the corner having an angle of no more than about 90 degrees, thus creating an edge which engages suture S and inhibits its movement whenfirst extremity1214 is tensioned. Thus, the cinching mechanism allows the suture be adjusted in one direction and constrains motion in the opposite direction. In this embodiment, the suture is preferably a suture having a flat or rectangular cross-section in order to increase friction, but other cross-sections may also be used including round suture. Theslots1208,1210 are sized and shaped accordingly, therefore in this embodiment, both slots are rectangular, but they could also be round.FIG. 21B is a side view ofFIG. 21A. Preferably this suture anchor and others described herein are fabricated by injection molding a polymer such as polyetheretherketone (PEEK), carbon reinforced PEEK or other polymers including biodegradable polymers such as polylactic acid (PLA) or polyglycolic acid (PGA). Thus, a single integral construct is provided requiring no assembly and no moving parts. Alternatively, some embodiments of anchors disclosed below may be moldable as a single piece, but may be molded into several components which are then assembled together.
Although not illustrated, it will be understood that any of the embodiments of the suture anchors of the invention described herein may include features on the exterior thereof to enhance retention of the anchor in bone or other tissue. Such features may comprise bumps, ridges, ribs, threads, scales, flaring wings, projections, or other structures to enhance friction or to mechanically engage the surrounding bone or tissue and resist proximal movement of the anchor after it has been fully inserted. Such features are well-known in the art, with examples illustrated in U.S. Pat. Nos. 6,554,852, 6,986,781, and 6,007,566, which are incorporated herein by reference.
FIGS. 22A-22B illustrate another cinching mechanism embodiment. This is similar to the one previously described inFIGS. 21A-21B with the major difference being that the cinching mechanism is enveloped by a housing.FIG. 22A shows a cross-section of the anchor and cinching mechanism. Theanchor1302 has a taperedtip1312 for alignment with a hole in bone or for providing a tip that can penetrate directly into bone. The anchor has acentral wall1322 arranged generally parallel to the longitudinal axis of the anchor with twotransverse apertures1308,1310 therein separated by atransverse bar1324, forming abuckle1306 for cinching the suture S. The cinching mechanism is surrounded by ahousing1304 having twoproximal openings1314,1316. The housing is preferably cylindrically shaped, but may have other configurations, including, but not limited to square, rectangular, oval, triangular, or other shapes. Any of the anchor housings disclosed herein may have any of these shapes. The housing guides thefirst extremity1318 andsecond extremity1320 fromapertures1314,1316 in a direction generally parallel towall1322 in lieu of relying upon the wall of the hole for this purpose as in the previous embodiment. Afirst extremity1318 of suture S enters thelower aperture1310 from a first side and exits that aperture on a second side, opposite the first side. The suture then enters theupper aperture1308 from the second side and exits the upper aperture on the first side. Asecond extremity1320 of the suture S exiting theupper aperture1308 is positioned under thefirst extremity1318 of suture S. In this embodiment, the suture S enters and exits the housing throughaperture1314, although the suture could also enter and exit theother aperture1316. Operation of the cinching mechanism is generally the same as previously described with respect toFIGS. 21A-21B. Pulling on the second extremity ofsuture1320 allows the suture to pass through thebuckle1306. However, pulling on the first extremity ofsuture1318 compresses the second extremity ofsuture1320 against thewall1322 creating friction between the suture and thebuckle1306, thereby preventing the suture from moving in that direction. Optionally, ridges, bumps, or other features may be provided on theface1326 ofwall1322 to enhance friction against second extremity ofsuture1320. This embodiment may be molded as a single integral construct or as two or more components that are assembled together. For example, the buckle and anchor tip may be molded as one component and the cylindrical housing may be molded as a second component. The two pieces may then be bonded, welded, fastened or snap fit together using techniques well known in the art.
FIG. 23 illustrates a perspective view of a suture anchor system having an outer anchor, an inner anchor positionable concentrically in the outer anchor, and a cinching mechanism in the inner anchor. Theouter anchor4202 includes a cylindrical shapedhousing4208 with acentral channel4210 and a pointed or taperedtip4204 similar to those previously described. The housing includes a plurality of longitudinally orientedslots4206 that form discrete sections at the proximal end of the housing which can flex outwardly. Additionally, the housing includes an outerannular flange4216 and an innerannular flange4220. Theinner anchor4212 has a distal pointed or tapereddistal tip4214 that may be used to help guide the inner anchor into the outer anchor or that may be driven directly into the bone or other tissue. The proximal end of the inner anchor has anannular flange4218 and also a cylindrical end with apassage4226 therethrough. A middle portion of the inner anchor between the distal tip and the proximal end includes a flat recessedsection4228 havingpassages4222,4224 therethrough and anopening4230 which communicates withpassage4226. In an exemplary embodiment the distal end ofinner anchor4212 has a sharpened tip adapted to penetrate the damaged tissue that is to be reattached, such that the inner anchor functions as a needle to pass directly through such tissue without the need for a separate device to create a penetration. In use, a first end of a suture (not shown) may be fixed to theouter anchor4202 and the suture may then be threaded throughapertures4222,4224 to form the cinching mechanism as shown in the embodiments illustrated inFIGS. 21A-21B or22A-22B. Once the outer anchor is positioned into bone or other tissue, the suture may be looped around damaged tissue or passed through a penetration in the damaged tissue and then either be inserted into the outer anchor and locked in place or positioned into the bone or other tissue separate from the outer anchor.Outer flanges4216,4218 on the outer and inner anchors are used as a seat for engagement by a delivery instrument to facilitate insertion of the anchors into the bone. Additionally, when the inner anchor is inserted into the outer anchor, theslots4206 allow the discrete sections of the housing to be deflected outwardly to receive the inner anchor then resiliently snap back inwardly to lock the inner anchor in place. Once the inner anchor has been advanced deep enough into the outer anchor, theflange4218 on the inner anchor will engage theflange4220 on the outer anchor and the two anchors will be locked together. The suture may then be adjusted by pulling it through the cinching mechanism as previously described with respect toFIGS. 21A-21B and22A-22B. In preferred embodiments, the outer diameter of the outer anchor is less than 4 mm and no more than 3.5 mm and the overall length of the inner and outer anchors when coupled together is less than 15 mm, and more preferably less than 12 mm. The inner and outer anchors are preferably each a single piece molded construct, preferably being molded from a polymer such as PEEK or carbon-fiber filled PEEK. One of skill in the art will appreciate that any of the other cinching mechanisms described herein my easily be substituted for the cinching mechanism shown inFIG. 23.
FIG. 24A illustrates a perspective view of another exemplary embodiment of a suture anchor having two stacked anchors and a cinching or locking mechanism for the suture.FIG. 24B is a cross-sectional view of the anchor inFIG. 24A taken along line A-A (along the longitudinal axis and after the anchor has been rotated approximately 90 degrees). The anchor system includes atop anchor4302 and abottom anchor4316. The bottom anchor generally consists of several cylindrical sections of varying diameters. The conicaldistal end4304 of thebottom anchor4316 is tapered or pointed to facilitate driving the anchor directly into bone or other tissue or to help center the bottom anchor into an existing pre-drilled hole. Achannel4306 passes transversely through the bottom anchor and may be used to fix a suture thereto. As shown inFIG. 24B, thechannel4306 has a smaller diameter section large enough to accommodate the diameter of the suture, and a larger diameter section which allows a knot to be tied in the suture, the knot being too large to pass through the smaller diameter section, thereby securing the suture in the channel. A proximal portion of thebottom anchor4316 has a central cavity adapted to receive and couple with the distal tip of thetop anchor4302. Both thetop anchor4302 andbottom anchor4316 have a plurality ofcircumferential ribs4308 disposed on their exterior to help hold the anchors in bone or tissue.Ribs4308 each have an angled bevel on their distal edges to allow the anchor to pass more easily into bone or tissue, while having a flat proximal aspect that engages the tissue or bone into which the anchor is disposed to resist migration of the anchor proximally. The top and bottom anchors are preferably of the same diameter so as to fit snugly in the same pre-drilled hole. The distal tip of thetop anchor4302 is received in the cavity in the proximal portion of thebottom anchor4316 and preferably includes some means of coupling the two anchors together, such as a friction fit between the interconnecting parts, or a coupling mechanism similar to that described in other embodiments disclosed herein. The proximal end of theupper anchor4302 includes acentral channel4314 that allows the suture to pass through into a recessed central portion of the anchor which includes a flattenedregion having apertures4310,4312 therethrough. The suture may be threaded throughapertures4310,4312 as described in the embodiments ofFIGS. 21A-21B andFIGS. 22A-22B. In use, with the suture pre-attached tobottom anchor4316 and pre-threaded throughapertures4310,4312, thebottom anchor4316 is driven directly into bone or inserted in a pre-drilled hole, and thetop anchor4302 is then looped around or passed directly through a penetration in the tissue to be repaired.Top anchor4302 is then inserted into the same hole in whichbottom anchor4316 is positioned until its distal tip seats within the proximal end of the bottom anchor. The suture may then be adjusted or locked as described above. It will be understood that thetop anchor4302 may have a sharpened distal tip to allow it to penetrate directly through the tissue to be repaired without need for a separate instrument to create a penetration.
FIGS. 25A-25B illustrate yet another exemplary embodiment of a suture anchor with cinching mechanism.FIG. 25A is a cross-sectional view ofFIG. 25B. Thesuture anchor1402 has a tapered or pointedtip1404 to help align it with a hole in the bone or to provide a tip that may be driven directly into bone. Acylindrical housing1406 surrounds the cinching mechanism which includes twocentral walls1408,1412 that are offset from one another in a direction transverse to the longitudinal axis of theanchor1402. The lowercentral wall1408 has alower aperture1410 passing therethrough and anupper aperture1414 is created by the space between the two offsetwalls1408,1412, forming abar1422 between the apertures. The top of the anchor is sealed except for anopening1420 that is sized to allow the suture S to enter and exit the anchor. Afirst extremity1418 of suture S enters the anchor throughopening1420 and travels down a first side ofcentral wall1412. The suture then crosses the central wall to the opposite, second side of thewall1412 by passing through a gap created by the offset between the upper1412 and lower1408 walls. The suture S then travels down the second side and enters anaperture1410 in thelower wall1408. Asecond extremity1416 of suture S exits theaperture1410 on the first side and travels up the anchor and out ofopening1420.Opening1420 helps orient the first and second extremities ofsuture1416,1418 so they are generally parallel with the face ofupper wall1412 as they enter and exit the anchor. In use, when thefirst extremity1418 of suture S is pulled, the suture will advance through the cinching mechanism and thus the suture S length and tension may be adjusted. However, when thesecond extremity1416 of suture S is pulled,first extremity1418 is compressed against theupper wall1412 and in particular thelower corner1424 ofupper wall1412, creating friction against the suture and preventing movement of the suture in that direction. Aligning the suture extremities to be parallel with one another and withupper wall1412, helps maximize friction between the suture extremities and the central wall. Thus, the suture may be adjusted in one direction only.
A further embodiment of a suture anchor according to the invention is illustrated inFIGS. 26A-26B.FIG. 26A illustrates a cross-section of the suture anchor andFIG. 26B illustrates another cross-section of the anchor rotated approximately 90 degrees. Thesuture anchor1502 includes a taperedtip1504 that generally takes the same form as those previously described above. Acylindrical housing1518 having acentral channel1516 surrounds the cinching mechanism which comprises abarrel insert1508 disposed in atransverse bore1506 in thehousing1518. Thebarrel insert1508 is transverse to the longitudinal axis of the anchor and preferably is orthogonal to the longitudinal axis.FIG. 26C illustrates thebarrel insert1508 removed from the anchor. Thebarrel1508 has anupper aperture1512 and alower aperture1514, both sized to accept suture, which are configured and operate in a manner similar to those described above in connection withFIGS. 21A-21B, and22A-22B. Anopening1510 in the top of thehousing1518 allows the suture to enter and exit the suture anchor. This construction allows the cinching mechanism (barrel1508) to be molded as a separate part from the remainder of the anchor, and the two parts are assembled by press fitting, bonding, or otherwise fixingbarrel1508 withinbore1506.
The previous embodiments have no moving parts and thus the suture may be adjusted and locked without actuating or moving any components. The size, shape, position, and orientation of all parts of the anchor remain the same whether the suture is being adjusted or locked. Other embodiments, such as those shown inFIGS. 27A-27F, include a cinching mechanism with at least one moving part.FIGS. 27A-27F illustrate a suture anchor similar to that shown inFIGS. 26A-26C, but in this embodiment thebarrel1508 is rotatable about a transverse axis from an unlocked position, shown inFIGS. 27A-27B, and27F, to a locked position shown inFIGS. 27C-27D, and27E.FIGS. 27A and 27B are cross-sections of the anchor taken at positions approximately 90 degrees apart from one another. InFIG. 27A, the suture S has afirst extremity1520 which extends downward throughaperture1510 and entersaperture1512 in therotatable barrel1508 from a first side. The suture exitsaperture1512 on a second side opposite the first, crosses under the barrel and entersaperture1514 from the second side, passes throughaperture1514 and asecond extremity1522 of the suture S exits the barrel on the first side. In the unlocked position, the barrel is positioned in the anchor such that bothapertures1512,1514 are generally facing upwards in a direction parallel to the longitudinal axis of the anchor. Apin1524 inbarrel1508 is movable within a curved channel in the wall ofhousing1518 and prevents the barrel from rotating beyond certain limits. Thus, when afirst extremity1520 of the suture is pulled the barrel rotates into the unlocked position and is prevented from further rotation by engagement of the pin with thehousing1518. With thebarrel1508 in the unlocked position, friction against the suture is minimized and suture length and tension may be easily adjusted. However, when thesecond extremity1522 of the suture S is pulled in a second direction opposite the first direction, the barrel will rotate into the locked position, preventing suture movement in that direction.
FIGS. 27C-27D illustrate the suture anchor ofFIGS. 26A-26C with the barrel rotated into the locked position.FIGS. 27C and 27D are cross-sections of the anchor taken at positions approximately 90 degrees apart from one another. When the suture is pulled in the second direction, thebarrel1508 rotates and locks the suture. In the locked position,apertures1512,1514 are oriented to face transverse to the longitudinal axis of theanchor1502, with both the first andsecond extremities1520,1522 of the suture extending from the apertures in a direction generally parallel to the lateral face ofbarrel1508. Locking occurs because thefirst extremity1520 is sandwiched between thesecond extremity1522 andbarrel1508 such that, whensecond extremity1522 is tensioned, thefirst extremity1520 is compressed against the wall ofbarrel1508 by thesecond extremity1522.
FIGS. 28A-28C illustrate another exemplary embodiment of a suture anchor having a cinching mechanism for adjusting the suture length and tension. This embodiment relies on the suture S crossing itself to create friction and compression on the suture that prevents movement of the suture in one direction while allowing movement in the opposite direction.FIG. 28A is a cross-section of thesuture anchor1602 which has a tapered or pointedtip1604 that generally takes the same form as previously described suture anchor tips. Acylindrical housing1606 encloses the cinching mechanism which includes twoguide members1614 and1616 transversely positioned in the suture anchor housing relative to the longitudinal axis of the suture anchor.Guide members1614,1616 are separated by a gap therebetween. Anupper opening1608 allows the suture S to enter and exit the suture anchor.Guide members1614,1616 preferably have enlargedmiddle portions1624,1626 which extend toward each other, and may optionally engage or be integrally attached to each other. The undersides ofmiddle portions1624,1626 comprise angled surfaces that merge toward one another, creating a notch N. A first extremity ofsuture1622 enters the suture anchor throughopening1608 and partially encircles thefirst guide member1616 and thesecond guide member1614. After the suture is looped over the top ofguide member1614, it bends downward between the two guide members and forms aloop1618 around an intermediate segment ofsuture1628 extending across notch N. The suture then extends upward between the two guide members and asecond extremity1620 of the suture S exits the suture anchor throughopening1608.FIG. 28B illustrates a cross-section ofanchor1602 taken along line A-A inFIG. 28A.
FIG. 28C illustrates the path of the suture S around the guides in greater detail. In use, the first extremity of suture may be pulled in the direction indicated byarrow1612 thereby allowing the suture length and tension to be adjusted. In this direction, the suture may pass freely around the guide members without binding. However, when the second extremity ofsuture1620 is pulled in the direction indicated byarrow1610, theloop1618 tightens around theintermediate segment1628, drawing it into notchN. Intermediate segment1628 is thus compressed against themiddle portions1624,1626 ofguide members1614,1616, thereby locking the suture in position.
FIGS. 29A-29C illustrate yet another embodiment of a cinching mechanism in a suture anchor.FIG. 29A is a cross-section of asuture anchor1702 having a taperedtip1704 that generally takes the same form as tips previously describe above. The suture anchor has acylindrical housing1706 that surrounds the cinching mechanism. A plurality ofopenings1708,1710,1712 and1714 on the top surface of the housing allow the suture to enter and exit the anchor. Afirst extremity1720 of suture S entersaperture1708 and extends into acentral channel1724 of the anchor. The cinching mechanism includes apartition1716 having a notchedend1718 in thecentral channel1724. Thefirst extremity1720 of the suture S extends down into thecentral channel1724 and has anintermediate segment1728 that extends underneath thepartition1716 transversely acrossnotch1718. Suture S then extends upward and exits the anchor fromaperture1710. The suture crosses over a top of the anchor and re-enters the anchor inaperture1712, extends down into the central channel and forms aloop1722 across theintermediate segment1728 of suture in a direction parallel to notch1718. Asecond extremity1726 of the suture extends upward fromloop1722 and exits the suture anchor through afourth aperture1714 in the top of the anchor.FIG. 29B is a top view of the anchor andFIG. 29C is a cross-section ofFIG. 29A taken along line A-A.
In operation, the first extremity ofsuture1720 may be pulled in a first direction and the suture is advanced through the cinching mechanism thereby adjusting length or tension in the suture. However, when thesecond extremity1726 is pulled in a second direction opposite the first direction,intermediate segment1728 is drawn upward byloop1722 intonotch1718, compressing it againstpartition1716 and binding the suture to prevent its movement in the second direction.
FIG. 30A illustrates a cut-away view of still another exemplary embodiment of a suture anchor having a cinching mechanism andFIG. 30B illustrates a cross-section ofFIG. 30A taken along line A-A. Thesuture anchor1802 has a tapered or pointedtip1804 that generally takes the same form as other anchor tips previously described above. Acylindrical housing1806 surrounds the cinching mechanism which includes a cylindricalcentral post1808 disposed in the anchor and having anaperture1810 extending therethrough.Openings1814 and1816 allow the suture S to enter and exit the anchor. In this embodiment, afirst extremity1820 of the suture S enters the anchor throughopening1814, travels down into the anchor and enterspassage1810 in thecentral post1808 from a first side. The suture S then exitspassage1810 on a second side opposite the first side and then partially loops around the central post, crossing over itself to form aloop1812 around thefirst extremity1820 of suture S. Asecond extremity1818 then travels up and out the anchor viaopening1816. When thefirst extremity1820 of suture S is pulled in a first direction, the suture S is easily advanced through the cinching mechanism allowing the suture tension and length to be adjusted. However, when thesecond extremity1818 is pulled in a second direction opposite the first direction,loop1812 tightens and compressesfirst extremity1820 againstpost1808, resulting in friction between the suture and thecentral post1808. This prevents the suture from being pulled in the second direction. Optionally, features such a bumps or ridges or coatings to enhance friction may be provided on the surface ofpost1808 to enhance the resistive forces on suture S.
FIG. 31A illustrates another exemplary embodiment of a suture anchor where the suture crosses over itself.FIG. 31B illustrates a cross-section ofFIG. 31A taken along line A-A. Thesuture anchor1902 includes a pointed or taperedtip1904 similar to other tips described above and the anchor also has acylindrical housing1906 similar to those described above. One of skill in the art will appreciate that while many of the embodiments described herein have a cylindrically shaped housing, other shapes may also be used in this or any of the embodiments disclosed herein, including, but not limited to square, rectangular, oval, triangular, or other symmetric and non-symmetrical configurations. The top of the housing has twoapertures1908,1910 that allow the suture S to enter and exit the anchor. A single aperture accommodating both extremities of the suture is also possible. In this embodiment, the cinching mechanism includes acentral bar1912 that is disposed in the anchor transverse to the longitudinal axis of the anchor, preferably orthogonal. Thecentral bar1912 includes twopassages1914,1916. In operation, afirst extremity1922 of the suture S entersaperture1910 and travels downward into the anchor and enterspassage1914 from the top. The suture then exitspassage1914, and has anintermediate segment1924 disposed substantially parallel along the underside ofcentral bar1912. Suture S then passes throughpassage1916, loops around thecentral bar1912 and forms aloop1918 over theintermediate segment1924. Asecond extremity1920 of the suture S then runs upward and out of the anchor throughaperture1908. The suture anchor operates similarly to other embodiments described above where the suture crosses over itself. In this embodiment, the suture may be advanced when thefirst extremity1922 is pulled in a first direction since the suture does not bind against itself or the central bar. However, when thesecond extremity1920 of suture S is pulled in a second direction opposite the first direction,loop1918 tightens up aroundintermediate segment1924, compressing it againstbar1912 to create friction between the suture and the central bar which prevents the suture from moving. Again,bar1912 may be provided with friction-enhancing features or a coatings to enhance the resistive force on suture S.
FIG. 32A illustrates another exemplary embodiment of a suture anchor where the suture crosses over itself.FIG. 32B is a cross-section ofFIG. 32A taken along line A-A, andFIG. 32C highlights a portion of the cinching mechanism in greater detail. Thesuture anchor2002 includes a tapered or pointedtip2004 similar to other anchor tips described previously and the anchor has acylindrical housing2006 withapertures2012,2014, and2016 in a sidewall of the housing.Aperture2022 is in a top surface of the housing. The cinching mechanism includes acradle2008 havingeyelets2010a,2010band a V-notchedchannel2026 for holding the suture S. The V-notch is transverse to the longitudinal axis of the cradle.Cradle2008 may be integrally formed withhousing2006 or may be a separate component attached to the inside wall of theanchor housing2006 using methods well known in the art (e.g. welding, screws, bonding, snap fitting, etc.). Afirst extremity2024 of the suture S enters the anchor and extends througheyelets2010a,2010bacross thecradle2008, with anintermediate portion2030 of suture S being substantially parallel to the longitudinal axis of the cradle and transverse to V-notchedchannel2026. The suture then exits a lower portion of the anchor via aside aperture2016. Thesuture2028 then wraps partially around an external surface of the housing and re-enters the anchor via anotherside aperture2012, The suture S then crosses overintermediate segment2030 in a direction substantially parallel to V notchedchannel2026 and exits the anchor viaaperture2014, forming aloop2018. Asecond extremity2020 then extends upward away from the anchor. The first extremity ofsuture2024 may be pulled in a first direction thereby adjusting suture tension or length, however, when thesecond extremity2020 of the suture is pulled in a second direction opposite the first direction, theloop2018 tightens down uponintermediate segment2030, pulling it into V-notchedchannel2026 to create friction between the suture and the cradle, thereby preventing the suture from moving in the second direction. Preferably, channels or recesses (not shown) are provided in the outer wall of the anchor to receive those portions of the suture running along the exterior of the anchor to allow the suture to slide easily even when the anchor is placed in bone.
FIG. 33 illustrates another embodiment of a suture anchor with a cinching mechanism. Thesuture anchor2102 includes a pointed or taperedtip2104 similar to those previously described and has acylindrical housing2106 containing the cinching mechanism. Anaperture2108 on the top surface of the housing allows the suture S to enter and exit the anchor. Acentral channel2114 directs the suture toward a slidingwedge2112 which is captured in achannel2110 of the anchor. The sliding wedge may have any number of shapes, but in this embodiment includes an angledupper surface2112athat corresponds to the angledupper surface2110aof thechannel2110 in which the wedge slides. Preferably the angledupper surface2110aforms an angle with thelongitudinal wall2120 ofcentral channel2114 which is less than 90 degrees, more preferably less than about 80 degrees, to increase the friction on the suture whensecond extremity2116 is tensioned (described below). Theupper surface2112aof thewedge2112 forms a similar angle with the side wall ofwedge2112, forming an acute angle along the upper edge. Thefirst extremity2118 of the suture enters the anchor viaaperture2108 and extends downward intocentral channel2114 and then loops around and partially encircles the slidingwedge2112. Asecond extremity2116 of the suture S then extends upward through thecentral channel2114 and exits the anchor throughaperture2108. The slidingwedge2112 allows the suture S to be adjusted in one direction while constraining movement in a second direction opposite the first direction. The suture may be adjusted in the first direction when thefirst extremity2118 is pulled because the suture S can pass easily around the slidingwedge2112. However, when thesecond extremity2116 of the suture S is pulled in the second direction opposite the first direction, the portion of the suture looped around the lower side of the sliding wedge will pull the sliding wedge upward until theupper surface2112acompresses the suture S between the sliding wedge and theangled wall2110aofchannel2110 preventing the suture from moving in the second direction. Moreover, the acute angle of the upper corner of the wedge provides a sharp edge which pinches the suture between the sliding wedge and the wall ofchannel2110, increasing resistance of its movement.
FIG. 34A illustrates a cross-section of another embodiment of a suture anchor having a cinching mechanism.FIG. 34B is also a cross-section of the anchor, this time rotated approximately 90 degrees relative to that ofFIG. 34A. Theanchor2202 includes a tapered or pointedtip2204 that generally takes the same form as other anchor tips previously described. The anchor also has acylindrical housing2206 that holds the suture and cinching mechanism and a top surface of the housing includes anaperture2214 which allows the suture S to enter and exit the anchor. In this embodiment, apin2208 slides along aslot2210 in a sidewall of the housing and serves as the wedging element. Afirst extremity2218 of suture S enters the anchor throughaperture2214 and extends downward through acentral channel2212.Central channel2212 has asloping sidewall2220 that narrows the width of the central channel asaperture2214 is approached. The suture partially encircles the slidingpin2208 and then asecond extremity2216 of the suture extends upward through thecentral channel2212 and exits the anchor viaaperture2214.Aperture2214 is laterally offset from the axis along whichpin2208 slides such that thesecond extremity2216 of the suture is directed in a lateral direction frompin2208 while thefirst extremity2218 is generally parallel to the axis of movement ofpin2208. In operation, when thefirst extremity2218 of suture S is pulled in a first direction, the lateral component of the force vector onpin2208 keepspin2208 from being forced upward toward thesloping wall2220 and allows the suture S to slip around thepin2208. Thus, when the suture is pulled in the first direction, suture length or tension may be adjusted. When thesecond extremity2216 of suture S is pulled in a second direction opposite the first direction, the forces on the suture will pull the sliding pin upward along theslot2210. As the pin moves upward, the space between the pin andsloping wall2220 decreases, resulting in the suture S being compressed between the pin and thesloping wall2220, thereby locking the suture and preventing it from moving any further. Thus the cinching mechanism allows the suture to be adjusted when pulled in one direction and locked in the opposite direction.
FIG. 35 illustrates a cross-section of yet another embodiment of a suture anchor having a cinching mechanism. This embodiment is similar to that ofFIG. 33 except that a stationary pin is provided in place of the sliding wedge. Theanchor2302 includes a pointedtip2304 and acylindrical housing2306. Apin2308 is mounted transversely in acentral channel2316. Afirst extremity2314 of suture S enters the anchor through anaperture2310 and extends downward intocentral channel2316 and then the suture loops around and partially encircles thepin2308. Asecond extremity2312 then extends upward and out of the anchor throughaperture2310. Preferablycentral channel2316 forms anupper wall2318 opposite the upper side ofpin2308 which is curved or angled so as to form an acutelyangled edge2320 around which the first extremity passes. Suture length or tension may be adjusted by pulling the first extremity in a first direction and this allows the suture to pass freely through the anchor and cinching mechanism. When thesecond extremity2312 of the suture is pulled in a second direction opposite the first direction, thesecond extremity2312 compresses thefirst extremity2314 against the wall ofcentral channel2316 and againstedge2320, pinching the suture S therebetween and preventing movement in the second direction. In alternative embodiments, thepin2308 may rotate in place about its longitudinal axis, thereby facilitating the movement of the suture thereover when thefirst extremity2314 is tensioned.
FIG. 36A illustrates a cross-section of another exemplary embodiment of a suture anchor having a cinching mechanism.FIG. 36B illustrates a cross-section of the embodiment inFIG. 36A rotated approximately 90 degrees. This embodiment is similar to that shown inFIGS. 34A-34B, except a fixedpin2412 is provided in place of the sloping wall of the earlier embodiment.Anchor2402 includes a pointedtip2404 and acylindrical housing2406. A slidingpin2408 is oriented transversely acrosshousing2406 and moves up and down alongslot2410 in the housing toward and away from fixedpin2412 which is mounted transversely near the upper or proximal end of the housing. Both pins are generally parallel to one another and transverse to the longitudinal axis of the anchor, preferably orthogonal. Afirst extremity2418 of the suture enters the anchor viaaperture2414 and extends downward intocentral channel2420 crossing under the fixedpin2412 and looping around and partially encircling the slidingpin2408. Asecond extremity2416 of the suture S then extends upward through the central channel and exits the anchor throughaperture2414. As in the embodiment ofFIGS. 34A-34B,aperture2414 is preferably laterally offset from the axis along which the slidingpin2408 slides, so that thefirst extremity2418 of suture S is directed in a lateral direction from slidingpin2408 in order to exit through the aperture. When thefirst extremity2418 is pulled in a first direction, the suture S slips around slidingpin2408 without forcing it toward fixedpin2412, allowing suture S to pass freely through the anchor and cinching mechanism. Thus suture length and tension may be adjusted by pulling the suture in the first direction. When thesecond extremity2416 is pulled in a second direction opposite the first direction, the suture pulls the slidingpin2408 upward alongslot2410 until the suture S is pinched between the slidingpin2408 and the fixedpin2412. Thus the suture cannot move when pulled in the second direction.
FIG. 37A illustrates an embodiment of a suture anchor and cinching mechanism in the unlocked configuration andFIG. 37B illustrates the suture anchor and cinching mechanism in the locked configuration. Theanchor2502 has a tapered or pointedtip2504 similar to those previously described and also has acylindrical housing2506 with acentral channel2516 and anaperture2508 on a top surface which allows the suture S to enter and exit the anchor. A pair ofpins2512,2514 are mounted tohousing2506 transversely acrosscentral channel2516 and are separated by a gap. Asplit retainer ring2510 is coupled to an inner wall ofhousing2506 so as to be aligned with the gap. Afirst extremity2522 of the suture S enters the anchor throughaperture2508 and extends downward into thecentral channel2516, passing under thesecond pin2514 and looping back over the top of thesecond pin2514 and through the gap between the two pins. The suture crosses over anintermediate segment2518 of the suture which extends across the gap, passes through thesplit ring retainer2510 and then passes back through the gap between the pins, forming aloop2524 around theintermediate segment2518. Asecond extremity2520 of the suture S then extends upward and exits the anchor throughaperture2508. As seen inFIG. 37A, when thefirst extremity2522 of suture S is pulled in a first direction, the suture will pass freely through the anchor and cinching mechanism without pulling out of thesplit retainer ring2510, thereby allowing suture to move so that length and tension may be adjusted. However, as seen inFIG. 37B, when thesecond extremity2520 of the suture S is pulled in a second direction opposite the first direction, the suture will pull out from thesplit retainer ring2510 and the loop2525 will then pullintermediate segment2518 into the gap between the pins, compressing the suture against the pins, and creating friction which prevents the suture from further movement.
FIGS. 38A-38B illustrate another embodiment of a suture anchor having a suture locking mechanism.FIG. 38A is a perspective view of the suture anchor andFIG. 38B shows a cross section of the locking mechanism.Anchor2606 includes a tapered or pointedtip2601 similar to other tips described above, and the cinching mechanism includes alocking bar2602 that slides along acentral wall2608. Suture S is threaded around the lockingbar2602. In this embodiment, the locking mechanism uses a floating suture locking mechanism within the anchor body. The suture S having ends2603,2604 is threaded through the floatinglocking bar2602 such that it is activated by pulling one end of the suture to engage the lock. When the other end is tensioned, the lock can release providing adjustable tensioning capabilities. Thecentral wall2608 is configured to receive the slidinglocking bar2602. As tension on thesuture thread end2603 is increased the sliding member is pulled proximally locking the suture in position. When tension is exerted onthread end2604 the system remains free to move and the suture slides past the locking bar. The floatinglocking bar2602 can be constructed of a different material than the anchor, such as a compressible material like a soft durometer polymer such as silicone or urethane. With a softer, compressible material the suture may be locked as the material compresses around it during tensioning. In addition, the floating lock may be molded with a variety of surface features to cause a more secure lock, such as bumps, ridges or the like.
FIG. 39 illustrates a variation of the embodiment inFIGS. 38A-38B with the major difference being that theanchor2702 includes acylindrical housing2704 that surrounds the cinching mechanism and also that the housing has anaperture2704aon its top or proximal surface for the suture S to enter and exit the anchor. In this embodiment, thehousing2704 guides the first andsecond extremities2603,2604 of suture S along a path parallel to the axis of movement of the floatinglocking bar2602. This ensures that whenfirst extremity2603 is tensioned, the force vectors are in the appropriate direction to pull floating locking bar proximally, thereby clamping the suture against thecentral wall2608.
FIG. 40 illustrates a variation of the embodiment inFIG. 39, this time the floatinglocking bar2602 inanchor2802 includes anaperture2804 in a middle portion thereof that allows the suture to pass therethrough instead of the suture passing over the top of the locking bar. This may allow more free movement of the suture whensecond extremity2604 is tensioned, and may increase and the clamping force of the floatinglocking bar2602 whenfirst extremity2603 is tensioned.
FIG. 41 illustrates a cross-section of another embodiment of a suture anchor and cinching mechanism. The anchor2902 has a pointed or taperedtip2904 similar to those previously described and also has acylindrical housing2906 with a pair ofapertures2914,2916 which allow the suture S to enter and exit the anchor. The anchor also has a U-shapedcentral channel2922 with a taperedportion2908 on one side of the U. The cinching mechanism includes asplit wedge2924 havingopposable jaws2910 each with a plurality ofteeth2912 for pinching the suture S. The split wedge is slidably disposed in the taperedportion2908 of thecentral channel2922. Afirst extremity2918 of suture S enters the anchor viaaperture2914 and extends downward into thecentral channel2922 in between thejaws2910. The suture exits the jaws and asecond extremity2920 of suture S passes through the bottom portion of the U shaped channel and exits the anchor throughaperture2916. In use, when thefirst extremity2918 of the suture S is pulled in a first direction away from the anchor,wedge2924 is pulled proximally in taperedchannel2908, allowingjaws2910 to separate. This allows the suture to pass freely through the U-shaped channel and the jaws thereby allowing the suture length or tension to be adjusted. However, when thesecond extremity2920 of the suture is pulled in a second direction opposite the first direction, away from the anchor, the suture will pull thesplit wedge2924 downward into the tapered portion of the channel such that the jaws pinch the suture and theteeth2912 bite into the suture, constraining suture movement relative to the anchor.
FIG. 42 illustrates a cross-section of another suture anchor embodiment.Anchor3002 includes a tapered or pointedtip3004 similar to those described above and has acylindrical housing3006 having acentral channel3022 and twoapertures3008,3010 on the proximal or top surface of the housing for the suture S to enter and exit the anchor. An arm3014 having a freedistal end3024 and anaperture3012 in a proximal portion thereof is fixed to a wall of the anchor and cantilevers into the central channel. Preferably,distal end3024 of arm3014 has a beveled tip, preferably being beveled only on one side (e.g. the upper side as shown) or with a steeper angle on one side than the other, so that the tip engages the suture more readily when pulled in one direction vs. the other. For the same purpose, arm3014 may be mounted non-orthogonally to the suture path (e.g. angled downwardly as shown), or constructed so as to resiliently deflect or bend preferentially in one direction vs. the other. Apin3016 generally transverse to the longitudinal axis of the central channel is mounted near the bottom of the central channel. Afirst extremity3018 of suture S enters the anchor viaaperture3010 and travels downward into thecentral channel3022 and passes throughaperture3012. The suture then passes under thepin3016 and past the distal end of the arm3014. Asecond extremity3020 of the suture then exits the anchor viaaperture3008. When thefirst extremity3018 of the suture S is pulled in a first direction away from the anchor, arm3014 deflects in the direction of suture movement and the suture S will pass freely through the anchor and cinching mechanism, allowing suture length or tension to be adjusted. However, when thesecond extremity3020 is pulled in a second direction opposite the first, away from the anchor, the beveled tip of arm3014 engages the suture and is pulled toward the opposing inner wall of the central channel, thereby pinching the suture and preventing its movement. The arm may be resilient and deflectable in which case the arm will deflect upward as the suture is pulled in the second direction and therefore the suture will be pinched between the arm and the wall of the central channel. Alternatively, the arm may be rigid but have a sharp tip that catches the suture and mechanically constrains it as it is pulled past the tip in the second direction. The suture may be round or flat and in some embodiments, the suture may have surface features which help it engage with the arm. For example, a flat suture may have discrete holes or ridges on it (similar to a cable tie).
FIG. 43 is a schematic illustration of another suture anchor and locking mechanism. Theanchor3302 includes a pointed or taperedtip3304 similar to those described above and also has acylindrical housing3306 with acentral channel3318. This embodiment is similar to that described above and illustrated inFIG. 42, having anarm3316 cantilevered from a wall of the central channel with a distal tip configured to engage suture S. In place ofpin3016 inFIG. 42, this embodiment has apost3308 secured to the bottom of thecentral channel3318 with apassage3310 throughpost3308. Afirst extremity3312 of the suture S enters the top of the anchor and passes through anaperture3320 in the arm. The suture then passes through thepassage3310 inpost3308 and then the suture extends upward past the arm and asecond extremity3314 of the suture S exits the anchor. This embodiment works in substantially the same manner as embodiment inFIG. 42.
FIG. 44 is a schematic illustration of a suture anchor and locking mechanism. Theanchor3402 includes a pointed or taperedtip3404 similar to those described above and also has acylindrical housing3406 having acentral channel3418 and anaperture3408 on the top of the housing. Anaperture3416 passes through a sidewall of the housing near the bottom of the central channel and anarm3410 is attached to a sidewall of the central channel and the arm cantilevers into the central channel. Afirst extremity3412 of the suture S extends downward along an outer surface of the anchor and enters the central channel viaaperture3416. Preferably, a longitudinal channel or recess (not shown) is provided in the outer wall of the anchor which receives the suture and allows it to slide easily even when the anchor is placed in bone. The suture then passes around the arm and asecond extremity3414 exits the anchor viaaperture3408. The cinching mechanism operates substantially similarly to the embodiments described inFIGS. 42 and 43 above.
FIG. 45 shows another schematic of a suture anchor and locking mechanism.Anchor3502 includes a pointed or taperedtip3504 similar to those described above and the anchor also has acylindrical housing3506 with acentral channel3524 and havingpassages3508 and3510 through a sidewall of the housing andpassage3518 through a sidewall on the opposite side of the housing. Anaperture3522 is on the top of the housing so that the suture may enter and exit the anchor. Anarm3512 is attached to a sidewall of the central channel and extends outwardly into the central channel like a cantilevered beam. An extremity of thesuture3516 enters the anchor viaaperture3522 and then passes downward in the central channel and has atip engaging segment3528 that passes around the tip ofarm3512. The suture then exits the anchor viapassage3508, travels a short distance along an outer surface of the anchor and re-enters the anchor viapassage3510, crossing the channel and then again exiting the anchor viapassage3520. The suture re-enters the anchor viapassage3518 and forms aloop3526 around the tip-engagingsegment3528 extending aroundarm3512, the suture then exiting throughpassage3518. The suture then extends upward along an outer surface of the anchor. Preferably, channels or recesses (not shown) are provided in the outer wall of the anchor to receive those extremities of the suture extending along the exterior to allow the suture to slide easily even when the anchor is placed in bone. In operation, when the suture is pulled in the direction ofend3514, thesuture loop3526 will pull the tip-engagingsegment3528 of the suture away from the arm thereby allowing the suture to move relative to the arm so that suture tension or length may be adjusted. When the suture is pulled in the opposite direction by tensioningend3516, the suture is pulled into engagement with the arm, preventing the suture from passing, and thus the suture is locked.
FIG. 46 is a schematic illustration of another suture anchor embodiment with locking mechanism.Anchor3602 includes a tapered or pointedtip3604 similar to those previously described above. Acylindrical housing3606 includes acentral channel3612 and a pair ofpassages3608,3610 in a sidewall of the housing. Anextremity3618 of the suture S enters the anchor from the top of the central channel and extends downward into the channel. The suture then exits the anchor viapassage3608 and passes along an outer surface of the anchor and then re-enters the anchor viapassage3610. Again, a longitudinal channel or recess (not shown) is preferably provided on the outer wall of thehousing3606 betweenpassages3608,3610 to receive the suture and allow it to slide freely without interference by surrounding bone or tissue. The suture then extends upward and anextremity3614 of the suture S exits the anchor via the top of the channel. Thepassages3608,3610 may be angled so that the suture may pass through them in one direction, while resistance is met in the opposite direction. Thus, in this embodiment, whensuture extremity3618 is pulled away from the anchor, it will pass freely through the passages allowing suture length or tension to be adjusted. However, whensuture extremity3614 is pulled away from the anchor,suture extremity3614 compressessuture extremity3618 against the inner wall of thecentral channel3612, constraining the suture from moving.
FIG. 47 is another schematic illustration of a suture anchor having a sliding clamping element.Anchor3702 includes a tapered or pointedtip3704 similar to those described above. The anchor also has acylindrical body3706 with acentral channel3712 extending therethrough. A pair ofpassages3708,3710 extend through a sidewall on one side of the anchor and anotherpassage3720 extends through the sidewall on an opposite side of the anchor. A slidingclamp3718 is disposed incentral channel3712 so that it may travel up and down the central channel (e.g. the sliding clamp may be free-floating or may ride in slots in the sidewall of the anchor). Arigid stop3714 is fixed in the central channel above (proximally of) the sliding clamp. Afirst extremity3722 of the suture S extends downward and runs alongside an exterior surface of the anchor and then enters the anchor viapassage3720. The suture crosses the central channel through atransverse passage3716 between the slidingclamp3718 and therigid stop3714. The suture exits the anchor viapassage3708 and passes along an outer surface of the anchor and then re-enters the anchor viapassage3710, extending downward and under the slidingclamp3718. Asecond extremity3724 of the suture S then exits the anchor viapassage3720. Longitudinal channels or recesses (not shown) are preferably provided on the outer wall of thebody3706 betweenpassages3708,3710 and frompassage3720 to the proximal end of the anchor to receive the suture and allow it to slide freely without interference by surrounding bone or tissue. In operation, thefirst extremity3722 of suture S may be pulled in a first direction away from the anchor without binding, thereby allowing suture length or tension to be adjusted. When thesecond extremity3724 of suture S is pulled away from the anchor in a second direction opposite the first direction, the suture will pull the slidingclamp3718 upward, pinching the suture between the top of the sliding clamp and the bottom of therigid stop3714, thereby locking the suture in position.
FIG. 48 illustrates another embodiment of a knotless cinching mechanism which has an optional feature to allow two-way suture movement and selective conversion to one-way cinching function.Anchor4002 includes acylindrical housing4004 and may have any of the distal tips described herein. Thehousing4004 hasapertures4022,4024 on the top surface that form an entrance to and an exit from aU-shaped channel4026 that holds a part of the suture S. Acentral post4006 joins the top of thehousing4004 with anend plate4008 havingapertures4010,4012 therethrough. An optional lubricious sheath orsuture cover4014 is removably positioned throughaperture4012 so as to enclose a portion of the suture alongpost4006 distal toaperture4012. Afirst extremity4016 of suture S entersaperture4012 and extends downward alongside thecentral post4006 entering theU-shaped channel4026 viaaperture4024. The suture travels through the U-shaped channel and travels upward, exiting the U-shaped channel viaaperture4022. The suture then loops around thecentral post4006, forming aloop4020 which partially encircles the central post along withsheath4014 and thefirst extremity4016 of suture S. Asecond extremity4018 of the suture S then extends upward and passes throughaperture4010 in theend plate4008. Thelubricious sheath4014 covers a portion of the suture S extending throughaperture4012 and also a portion of the suture S underneathloop4020. The lubricious sheath has sufficient radial strength to keep from collapsing on the underlying suture whenloop4020 is cinched down, and lubricous enough to allow the suture to slide through it. When thesheath4014 is positioned over the suture, either thefirst extremity4016 or second extremity of suture S may be pulled away from the anchor and the suture will pass freely through the anchor and cinching mechanism since the suture will glide through the lubricious sheath even thoughloop4020 may be tightening around it. Once thesheath4014 is refracted or removed the sutureunderlying loop4020 may be engaged by the loop such that, when thesecond extremity4018 of suture S is pulled in a second direction away from the anchor and opposite the first direction,loop4020 will cinch down onfirst extremity4016 to compress it and create friction between the suture and the central post, preventing the suture from moving in the second direction. Even with the sheath removed, however, applying tension tofirst extremity4016 in the first direction will allow the suture to move. If a sufficiently flexible material is used,sheath4014 may extend proximally over suture S a sufficient distance to allow the surgeon to grasp it. Alternatively,sheath4014 may comprise a short and more rigid segment and it may be coupled to a flexible tether or length of suture (not shown) which may extend away from the surgical site, preferably out of the patient's body, to allow the surgeon to retract or remove the sheath at the desired time. It will be understood that the embodiment illustrated inFIG. 40 may also be used withoutsheath4014, wherein it will operate solely as a one-way cinching mechanism as with other embodiments described herein.
FIG. 49A illustrates another exemplary embodiment of a suture anchor having a locking mechanism.FIG. 49B schematically illustrates a side cross-sectional view ofFIG. 49A. Theanchor4102 may have a cylindrical housing (not illustrated) and tip (not illustrated) similar to other embodiments described above and acentral wall4108 may be disposed in the anchor housing. Upper andlower apertures4106,4104 are disposed inwall4108. A removable wedge element4114 (best seen inFIG. 49B) is positionable in the anchor between afirst extremity4112 of the suture and asecond extremity4110 of the suture. Thewedge element4114 is arch-shaped on its innerside facing wall4108 so as not to clamp thefirst extremity4112 of suture S againstwall4108 and to allow suture S to slide.Wedge element4114 may also include a longitudinal groove orchannel4116 on its outer side to receive thesecond extremity4110 of the suture and allow it to slide.Wedge element4114 preferably has a distal end which has a curvature or angle selected to guide suture S in a more lateral direction away fromlower aperture4104 so as to minimize friction withwall4108 adjacent to the aperture. Thefirst extremity4112 of the suture S extends downward and substantially parallel with the centralwall entering aperture4106 from a first side and then travels along an outside surface of the central wall, enteringaperture4104 from a second side opposite the first side. The suture S then loops around the removable wedge element partially encircling it. Asecond extremity4110 of the suture S then extends upward and out of the anchor. Thus, when the removable wedge element is disposed in between the suture and the central wall, the second extremity of the suture gently exitsaperture4104 and gently curves around the wedge. When thefirst extremity4112 of the suture is pulled in a first direction away from the anchor, the suture will pass freely through the apertures of the central wall and thus the suture length or tension may be adjusted. Additionally, with the wedge element in place, thesecond extremity4110 of the suture S may also be pulled in a second direction opposite the first direction and away from the anchor and the suture will also move freely through the cinching mechanism. Thus the suture S may be tightened or loosened by pulling the suture in either the first or the second direction. When theremovable wedge element4114 is removed from its position between the suture and the central wall, the angle that the suture exitsaperture4014 will increase and be close to perpendicular and thesecond extremity4110 is allowed direct contact withfirst extremity4112. Thus, when thesecond extremity4110 of the suture S is pulled in the second direction, the suture will bind against an edge ofaperture4104 andsecond extremity4110 will compressfirst extremity4112 againstwall4108, preventing the suture from moving in the second direction. Theapertures4104,4106 may be angled non-orthogonally to the face of the wall to optimize slidability and friction in different directions. For example, one or both ofapertures4104,4108 may be angled to slope downward (distally) toward the inner side of the wall so as to create a sharper edge along the upper side of the aperture thereby increasing resistance on suture movement. Moreover, the shape of theremovable wedge4114 may also be adjusted to optimize slidability of the suture in the first and second directions.FIG. 49C illustrates the cinching mechanism when the removable wedge has been removed.
FIGS. 50A-50C illustrate cross-sections of another embodiment of a knotless suture anchor system having anouter anchor7802 and aninner anchor7816.FIG. 50A shows the anchor unloaded,FIG. 50B shows a suture S being loaded into the anchor, andFIG. 50C shows the anchor locked. Theouter anchor7802 has acentral channel7810 with internal threads orribs7804 for engaging the threads orribs7806 on theinner anchor7816. A suture orwire guide7810 forming aloop7811 withlegs7810a,7810b, is attached to theinner anchor7816 and passes through anaxial passage7812ain a stranglingmember7812 so as to act as a rail over which stranglingmember7812 slides. In use, theinner anchor7816 is retracted proximally or unthreaded sufficiently so that the stranglingmember7812 is exposed from thecentral channel7810. As seen inFIG. 50B, alasso7814aof suture, wire, or other flexible material passes throughloop7811 inwire guide7810, around one side of stranglingmember7812 and between thelegs7810a,7810bofwire guide7810 on the lower side of stranglingmember7812 and has afree end7814band acapture loop7814con the opposite end. The anchor system is pre loaded withlasso7814athreaded in this manner so that after a suture is passed through or around the tissue to be repaired, the suture ends may be passed through thecapture loop7814cand the free end oflasso7814athen pulled to draw the suture through the wire guide loop both distally and proximally of stranglingmember7812. Thus the one-way cinching mechanism may be threaded with a suture by the surgeon during a surgical procedure. Theinner anchor7816 is then advanced distally into thecentral channel7808 so that the stranglingmember7812 is disposed in the central channel and the two ends7814a,7814bextend proximally from theanchor7802, as seen inFIG. 50C. Thus, whenfree end7814ais pulled, the length or tension of suture S may be adjusted. However, whenfree end7814bis pulled, the suture S will force the stranglingmember7812 to move upward along thewire guide7810 until the suture is pinched between a top portion of the stranglingmember7812 and thewire guide7810, thereby preventing further movement of the suture.
FIGS. 51A-51B illustrate another exemplary embodiment of a suture anchor cinching mechanism.FIG. 51A shows a schematic of the anchor andFIG. 51B illustrates a cross-section of the anchor. Theanchor7602 has a generally cylindrically shaped housing with a pointeddistal tip7604, acentral channel7606, and a stranglingshuttle7608 that slides along a suture orwire guide7610. Thewire guide7610 has both ends7612a,7612battached to a lower portion of theanchor7602 and a loopedregion7614 extends through acentral passage7607 through the stranglingshuttle7608. A suture S extends through theloop7614 on one side of stranglingshuttle7608 and is wrapped around theshuttle7608 passing between the twolegs7610a,7610bofwire guide7610 on the opposite side of stranglingshuttle7608 such that bothfree ends7616a,7616bextend proximally from theanchor7602. In use, whenfree end7616bis pulled, the length or tension of suture S may be adjusted as the suture will slide around the stranglingshuttle7608. However, when the otherfree end7616ais pulled, the stranglingshuttle7608 will be pulled up and slide along thewire guide7610 until a portion of the suture S is pinched between the top surface of the stranglingshuttle7608 and theloop7614 of thewire guide7610. Once pinched, the suture S will be constrained from further movement. Thus, the cinching mechanism allows one-way adjustment of the suture.FIG. 51C illustrates a perspective view of thestrangling element7608, except this time with two sutures S passing therearound. Thus, the cinching mechanism may be used to allow one-way adjustment of more than one suture. In this embodiment, free ends7616a,7618amay be pulled to adjust length or tension in the sutures, while pulling the oppositefree ends7616b,7618bwill lock the suture and prevent further movement.
FIGS. 52A-52B illustrate still another exemplary embodiment of a knotless suture anchor system having anouter anchor7702 and an innertissue piercing anchor7712. Theouter anchor7702 has a generally cylindrically shaped body with a tapereddistal tip7704, acentral channel7706 and atransverse channel7720.Concave channels7708,7710 run axially along the outer surface of theouter anchor7702 and allow suture S to seat therein without being pinched between the anchor and the bone. The outer anchor also has a floating element7728 (seen inFIG. 52B) which slides axially along thecentral channel7706. The innertissue piercing anchor7712 has a sharp pointeddistal tip7716 that allows theinner anchor7712 to pass easily through tissue such as a torn labrum or rotator cuff and has ribs orthreads7714 or other surface features for engaging the corresponding surface features7724 on the inner surface ofouter anchor7702. A length of suture S is attached with aknot7718, crimp or other means to theinner anchor7712. The suture then runs along an outer surface of theouter anchor7702 inchannel7708 and passes throughtransverse channel7720 and extends up along an opposite surface of theanchor7702 inchannel7710. Afree end7722 extends proximally away from theanchors7702,7712. In use, damaged tissue (not illustrated) is captured by passing the piercinganchor7712 therethrough or by looping the suture therearound to create arepair loop7726. Theinner anchor7702 is then threaded or pushed into thecentral channel7706 of theouter anchor7702. As theinner anchor7712 is advanced into thecentral channel7706, it engages the floatingelement7728 and forces the floating element downward until it pinches the suture passing through thetransverse channel7720, thereby locking the suture in position. An advantage of this type of suture anchor is that the inner anchor may be released from the outer anchor by unthreading, thereby allowing additional adjustments to suture length or tension.
Deployment:
Suture anchors often are placed into pre-drilled holes in the bone or other tissue substrate to which damaged tissue is to be re-attached.FIG. 53 shows apre-drilled hole4402 obscured by a torn labrum L that is to be re-attached to the rim R of an acetabulum A. In the case of re-attaching a torn labrum to an acetabular rim, the holes are positioned underneath the torn labrum and they may be difficult to see or locate with arthroscopic instruments after the drill or hole punch is removed since the labrum will cover the hole and obscure its location. This makes it difficult to find and position the suture anchor into the hole during the surgical procedure. This problem may become even more acute after delivering a first anchor and attempting to deliver a second anchor into the same pre-drilled hole. With the labrum captured by the suture extending between the two anchors, it becomes more difficult to move the labrum out of the way in order to locate the target hole for the second anchor.FIG. 54 illustrates a method for locating a pre-drilled hole. A sutureanchor delivery instrument4504 may include anoptical coupling4502 so that an external light source (not shown) may be optically coupled to the sutureanchor delivery instrument4504. Thus, light will be delivered from a light source through a light pipe such as a fiber optic to the area adjacent thepre-drilled hole4508. The light4506 illuminates the area with enough intensity and with a suitable wavelength so that the light is transmitted through the labrum L to illuminate the underlying bone andhole4508. The light may be from an LED, laser or other suitable source. The light pipe may comprise one or more optical fibers or other suitable light transmission means and may be disposed in a lumen in the delivery instrument or in a separate member which is positioned alongside the delivery instrument or coupled to its exterior. With the location of the pre-drilled hole visible, the surgeon may deliver the suture anchor into the hole using the delivery instrument.
FIG. 55 illustrates a variation of the embodiment inFIG. 19. In this exemplary embodiment, twoanchors92,96 are placed end-to-end into engagement with one another. This variation is similar to that ofFIG. 19, with the major difference being that thecoupling element94 is fixed to the top orproximal-most anchor96 instead of on the bottom ordistal-most anchor92. Thecoupling element94 may take any of forms previously described with respect tocoupling element83 inFIG. 19. Additionally, in this embodiment, apusher tube98 may be used to help driveanchor96 into the bone or to help drive the two anchors into engagement with one another. Adistal end98aof thepusher tube98 may be placed against ashoulder96aof theupper anchor96 and used to press the two anchors together. Alternatively, the proximal end of thepusher tube98 may also be impacted with a hammer or similar object to help drive the two anchors into the bone and into engagement with one another. It will be understood that the distal andproximal anchors92,94 will be coupled to a length of suture and will include a knotless cinching mechanism in one or both anchors as described elsewhere herein.
FIGS. 56A-56B illustrate an exemplary embodiment of a delivery instrument for deploying suture anchors in an end-to-end configuration.FIG. 56B is a cross-section ofFIG. 56A and highlights the internal components of the delivery instrument. Anouter shaft1102 carries bothanchors1104,1116 and asuture1110 is coupled to each anchor. A plurality ofslots1106 near the distal end of theouter shaft1102 form severaldeflectable arms1114. Deflectable arms have inwardly extendingfingers1118 at their distal end which engage the proximal end of thedistal anchor1104.Pusher rod1108 is slidably disposed inouter shaft1102 and is engaged with the proximal end ofsuture anchor1116. The distal end ofanchor1116 is also engaged with the proximal end ofanchor1104.Coupling mechanisms1112 such as snap fits, threaded rods, or other joining mechanisms are used to join the twoanchors1104,1116 together as described above. In use,pusher rod1108 is slidably advanced withinouter shaft1102 so that thefirst anchor1104 is exposed from the distal end ofouter shaft1102. As the pusher rod advances thefirst anchor1104 distally, thearms1114 deflect radially outward until theanchor1104 is exposed distally thereof. Thearms1114 return to their radially inward position and thus thefingers1118 at the distal end of thearms1114acan then be used to push the first anchor into the bone or the pre-drilled hole in the bone.Shaft1102 andpusher rod1108 are then retracted along withproximal-most anchor1116 to decouple it from thedistal-most anchor1104. Once the first anchor is in place, the instrument is manipulated so as to capture the target tissue with thesuture1110.Pusher rod1108 is then advanced withinshaft1102 to pushproximal-most anchor1116 beyondfingers1118 ondeflectable arms1114. The deflectable arms flare outwardly as the second anchor is advanced past the arms, and then the arms return to their unbiased position where they can be used to push the second anchor into the bone or the hole and also into engagement with thefirst anchor1104. Once the two anchors have been coupled together (e.g. by threading them together or snap fitting or press fitting them together), thepusher rod1108 may be released from thesecond anchor1116 by unthreading, unsnapping or otherwise uncoupling thecoupling mechanism1112 between the two components.
FIG. 57 illustrates another method of locating a suture anchor hole without requiring that a drill guide is kept in place. Once a hole7904 has been pre-drilled into the bone7902 a first anchor7906 to which a guide filament S of wire, suture or other flexible material is coupled may be positioned into the hole7904. Guide filament S may be used to help direct a delivery instrument7908 carrying a second anchor7909 through the tissue and blood, back to the hole7904. Guide filament S may pass slidably through a loop, lasso7910 or other coupling mechanism on the second anchor7909 or delivery instrument7908 over which it can be advanced back to the hole7904. In this manner, the delivery instrument7908 may be advanced along the guide filament S easily back to the hole7904 to deliver additional suture, suture anchors or other materials required for the surgical repair. First anchor7906 need not have the level of retention force that is required for the second anchor which is to be used in the surgical repair itself, needing only to hold the guide filament S while it is tensioned sufficiently to guide instruments back to hole7904. First anchor7906 may thus be a self expanding resilient wire coil or ball of randomly bent wire, a self-expanding stent-like structure, or a more rigid frictionally-retained structure adapted to be pressed or pounded into hole7904. Alternatively, first anchor7906 may have scales, barbs, wings or similar expanding structures on its outer surface to retain it within the hole. Any of the embodiments of the anchors disclosed elsewhere herein may also be used.
FIGS. 58A-58H illustrate another exemplary method of re-attaching damaged tissue to a substrate tissue such as bone using a single anchor with a closed loop. A suture passer and anchor delivery instrument8402 carries an anchor8406 (best seen inFIG. 58E), a suture S and a pair of curved grasping jaws8404a,8404bwithin the outer shaft8422. The distal tips8416a,8416bof jaws8404a,8404bare sharpened so as to penetrate tissue. Jaws8404a,8404bhave a discontinuous eyelet, hook, or other means (not shown) near their distal tips to releasably hold a loop of suture S between them and are rotatable about the longitudinal axis of the instrument8402 so that the distal tips8416a,816bof the jaws are movable from a closed position adjacent to one another to an open position in which they are spaced apart with the suture extending between them. The instrument8402 is advanced adjacent the damaged tissue, here a torn labrum L as seen inFIG. 58A. The grasping jaws8404a,8404bare then deployed from the instrument8402 and passed through the torn labrum L inFIG. 58B in the closed position. A suture loop (not visible in the figure) is carried by the jaws and is thus passed through the labrum therewith. The instrument8402 is then positioned so that it is substantially perpendicular to the torn tissue or in any other desired orientation, as illustrated inFIG. 58C. InFIG. 58D, the grasping jaws8404a,8404bare then opened after passing through the labrum so that a portion of the suture S passes between both jaws, thus opening loop8420 in the suture. The anchor8406 is the deployed from the instrument8402 inFIG. 58E such that the anchor passes between the jaws8404a,8404band through the loop8420. An inner shaft8424 carrying anchor8406 is advanced from the outer shaft8422 of the instrument8402, to drive the anchor directly into the bone or into a pre-drilled hole as seen inFIG. 58F. Once the anchor8406 is positioned in the acetabulum, inner shaft8424 is decoupled from the anchor8406 and the instrument8402 may be retracted away from the bone, exposing the three segments of suture S extending from anchor8406, as seen inFIG. 58G. The jaws are then decoupled from the suture loop and refracted back through the labrum and the instrument8402 is removed, as illustrated inFIG. 58H. The free end8410 of the suture S may then be pulled in order to adjust length or tension of the suture and secure the labrum with the acetabulum. The anchor may have any of the cinching mechanisms described above.
FIGS. 59A-59D illustrate an alternative embodiment of a suture anchor delivery instrument and method of use. Ahole4612 is pre-drilled in the acetabulum A as seen inFIG. 59A. A sutureanchor delivery instrument4602 includes atubular shaft4620 and a grasping mechanism having a pair ofopposable jaws4604,4606 and a penetratingneedle4608 slidably mounted within thetubular shaft4620. The penetrating needle has ahook4608aformed near its distal end which is adapted to grasp a suture held by fixedjaw4604 as described below. A C-shaped fixedjaw4604 extends from the distal end oftubular shaft4620 and forms achannel4622 configured to receive the target tissue to be repaired. Amovable jaw4606 is pivotably mounted totubular shaft4620 and is movable so as to extend across the open side ofchannel4622. A suture S is coupled with aknot4616 or by other means to afirst anchor4610 and extends through fixedjaw4604 intotubular shaft4620. Thefirst anchor4610 is releasably held at the distal end of fixedjaw4604 to extend distally therefrom. In use,first anchor4610 is deployed from the fixedjaw4604 into thehole4612 and then the torn labrum L is positioned inchannel4622 and retained therein by closingmovable jaw4606. The piercingneedle4608 is then advanced acrosschannel4622 and through the torn labrum L until it engages and captures the suture S held by fixedjaw4604, as seen inFIG. 59B. The needle is retracted, pulling the suture S through the labrum. The instrument is then removed, with the suture S being slidably advanced from thetubular shaft4620. Asecond anchor4616, preferably having one of the cinching mechanisms described herein, is then coupled to the suture as illustrated inFIG. 59C. Thesecond anchor4616 is then positioned end-to-end or concentrically with thefirst anchor4610 inhole4612 as described elsewhere herein. Alternativelysecond anchor4616 may be placed in a separate hole in the acetabulum A. Thefree end4618 of the suture S may then be pulled in order to adjust length and tension in the suture as desired and to secure the torn labrum L securely to the acetabular rim substrate.
An exemplary instrument for delivering a suture anchor is schematically illustrated inFIGS. 60A-60B. Thedelivery instrument7202 includes an elongateouter shaft7224 having acentral channel7222 in which thesuture anchor7204 and suture S are disposed.Suture anchor7204 may taken the form of any suture anchor disclosed herein. Anoptional pusher tube7218 is also disposed inchannel7222 along with asuture spreader7206 having a pair ofspreadable arms7208a,7208bcoupled to anelongate shaft7216. The free ends7212,7214 of the suture S extending away from thesuture anchor7204 may extend through thecentral channel7222 toward a proximal end of thedelivery instrument7202 so that the ends may be manipulated by a physician outside of the patient's body, or the suture ends may only advance a short distance in thecentral channel7222. In operation, thedelivery instrument7202 is advanced toward a treatment site and thesuture spreader7206 is advanced from thecentral channel7222 so that thearms7208a,7208bare unconstrained and expand outward. The suture S is coupled to botharms7208a,7208bsuch that when the arms expand outwardly, the suture S forms aloop7210 as seen inFIG. 60B. Thesuture spreader7206 may be a superelastic or shape memory material such as Nitinol that is pre-shaped to spread to a desired configuration. The suture S may be looped around the tissue to be repaired (e.g. torn labrum, not illustrated) and then anchor7204 is then advanced distally out of thecentral channel7222 and passes through thesuture loop7210 into ahole7220 pre-drilled in bone. Thesuture anchor7204 may be advanced out of thecentral channel7222 by actuating thepusher tube7218 or other mechanisms may be employed. The free ends7212,7214 of the suture S can then be pulled in order to adjust length or tension in the suture S and the excess suture may be severed. In this embodiment, thesuture anchor7202 is advanced independently from thesuture spreader7206, however in alternative embodiments the two may be operatively coupled together so that they are both advanced from the delivery instrument together.
Thesuture spreader7206 inFIGS. 60A-60B is formed from a wire-like material and the suture is coupled toarms7208a,7208bpreferably by passing the suture S through eyelets (not illustrated) at the ends. This configuration is advantageous because it presents a low profile that may be easily be contained inshaft7224.FIG. 61A illustrates thesuture spreader arms7304a,7304bin greater detail. Each arm includes anupper finger7306 and alower finger7318 that are biased to form aneyelet loop7310 and so that the tips of the fingers close against one another forming aslit7312. The suture S may be passed through theeyelet loop7310 on eachsuture spreader arm7304a,7304b. Theeyelet loop7310 may be sized so that the suture S is loosely held by thefingers7306,7318 and thus when thespreader arms7304a,7304bexpand outward, arms will open up forming suture loop7305 without binding. Moreover, theslit7312 in eachspreader arm7304a,7304ballows the suture S to be disengaged from the spreader by pulling the suture therepast which spreads thefingers7306,7318 apart, opening the slit enough to release the suture S.FIG. 61B illustrates a side view of thesuture spreader arm7304a,7304b. In an alternative embodiment shown inFIG. 61C, thefingers7306a,7306bare shaped to form a smooth arcuate tip7314 that will not cause trauma to adjacent tissue as it is advanced and manipulated.
An alternative embodiment of a suture spreader is illustrated inFIGS. 62A-62B. Thesuture spreader7402 includes a pair of substantiallycylindrical arms7404,7406 that extend substantially parallel to one another. The suture S may be wrapped7412 around each arm during deployment but may be easily slid off from eacharm7404,7406 when thesuture spreader7402 is detached from the suture S. Thearms7404,7406 may be fabricated from a metallic or polymer wire or pins, or they may be machined from a single integral piece and may be superelastic, shape memory or spring temper to spring outwardly upon deployment from a delivery instrument. The embodiment inFIG. 62A may includearms7404,7406 having a straight section for wrapping the suture S therearound and a flatcylindrical end7414, or a roundeddistal tip7418 as seen inFIG. 62B to minimize trauma to adjacent tissue during deployment as well as to facilitate insertion into the treatment area.
FIG. 63 illustrates another alternative embodiment of a suture spreader. Thesuture spreader7502 includes a pair of substantiallyparallel arms7504,7506. Each arm includes a pair offingers7508,7510 that form areceiving slot7512 for receiving the suture S. The receivingslot7512 may be sized to accommodate a number of different suture sizes and geometries. Similar to other suture spreaders described above, thearms7504,7506 will expand outwardly upon release from the delivery instrument, thereby forming a large suture loop7305 (FIG. 61A) through which the suture anchor may pass. The arms may be fabricated from similar materials as discussed above with reference toFIGS. 61A-61C andFIGS. 62A-62B.
FIGS. 64A-64H illustrate an exemplary method of using a suture anchoring system having an anchor and a needle to reattach a torn labrum to the acetabular rim A.FIG. 64A shows the labrum L torn from the acetabular rim A. InFIG. 64B, the torn labrum L is moved to one side and adelivery instrument6702 is used to position asuture anchor6704 into the acetabular rim. The anchor may be driven through the cartilage into the bone of the acetabulum or the anchor may me positioned in a pre-drilled hole. Thedelivery instrument6702 is then retracted away from the anchor such that suture S is metered out and partially encircles the torn labrum L, as shown inFIG. 64C. One end of the suture is attached to theanchor6704 and the other end of the suture S is attached to atissue piercing needle6706 carried by thedelivery instrument6702. After partially encircling the torn labrum with the suture S, theneedle6706 is advanced from the delivery instrument so that it pierces the torn labrum L as illustrated inFIG. 64D.FIG. 64E shows apusher rod6708 advanced from thedelivery instrument6702 so as to push theneedle6706 through the labrum L and into a central channel of theanchor6704. A locking mechanism (not illustrated) couples the needle and the anchor together and the delivery instrument is then retracted away from the torn labrum L, metering out additional suture, creating afree end6710 as seen inFIG. 64F. The delivery instrument is then removed from the surgical field as shown inFIG. 64G and then the surgeon can adjust tension in the suture by pulling thefree end6710 of the suture and cutting away and excess suture. The labrum L is now re-attached to the acetabular rim A where it will heal. This process may be repeated as many times as required along the length of the torn labrum.
FIGS. 65A-65H illustrate another exemplary method of re-attaching tissue. InFIG. 65A a torn labrum L is shown separated from the acetabular rim A. Adelivery instrument6802 is used to push the labrum L aside and insert ananchor6804 into the acetabulum A, as shown inFIG. 65B. Theanchor6804 may be inserted directly into the acetabular rim A or in a hole pre-drilled in the acetabulum A. InFIG. 65C thedelivery instrument6802 is retracted away from the labrum L and atissue piercing needle6806 is then deployed from thedelivery instrument6802. Thedelivery instrument6802 is advanced distally so thatneedle6806 pierces and passes through the labrum, pulling a portion of the suture with it as seen inFIG. 65D. Apusher rod6808 is then advanced distally from thedelivery instrument6802 so as to push theneedle6806 into a central channel of theanchor6804 where the two lock together, as shown inFIG. 65E. Thedelivery instrument6802 is then retraced away from the labrum L. Afree end6810 of the suture S is also pulled away from the labrum L, as illustrated inFIG. 65F. InFIG. 65G, thedelivery instrument6802 is removed from the surgical field and inFIG. 65H, thefree end6810 is pulled by the surgeon in order to adjust length and tension in the suture which captures the labrum L. The excess suture is then severed and removed. This process may be repeated along the length of the torn labrum.
A number of the suture anchor systems described above use two anchors placed end-to-end in the bone. In some cases it may be preferable to place only a single anchor into the bone. The exemplary embodiment ofFIG. 66 illustrates a single anchor embodiment. Suture S is pre-threaded in ananchor4802 which may include acinching mechanism4804, such as any of those disclosed herein. Suture S forms aloop4808 which is first passed around the labrum L or through a penetration therein so that the end of the loop is exposed on the opposite side of the labrum.Suture anchor4802 is then passed through the interior of the exposed end of the loop thereby completely capturing the labrum.Anchor4802 is then inserted directly into the acetabulum A or into a hole pre-drilled into the bone. Thefree end4806 of the suture exits theanchor4802 and may be pulled to adjust the length or tension in the suture.
Another exemplary embodiment of a suture anchor system using only a single anchor is illustrated inFIG. 67. This embodiment is similar to that ofFIG. 66 except thatanchor4902 has two one-way cinching mechanisms to allow eitherend4904 or end4906 of suture S to be adjustably tensioned. The labral tissue is captured and the anchor placed in the manner described above in connection withFIG. 66.
FIG. 68 shows another exemplary embodiment of a suture anchor system requiring only a single anchor. In this embodiment, one end of a suture S has apre-formed loop5002 that is first inserted through or passed around the labrum L. Anchor5006 is then passed through theloop5002 and inserted into the acetabulum by driving it into the bone or placing it in a pre-drilled hole. The suture passes through a one-way cinching mechanism (not shown) in anchor5006 and afree end5004 exits the anchor. The cinching mechanism may be any of those described in this specification. Thefree end5004 may be pulled in order to adjust length or tension in the suture.
FIG. 69 illustrates still another exemplary embodiment of a suture anchor system with a single anchor. One end of a suture S is attached to theanchor5102 with aknot5104 or other coupling mechanism. Theother end5110 passes through a cinching mechanism in the anchor, which may be any of those disclosed herein, forming aclosed loop5112. In this embodiment, theloop5112 may be passed through the labrum using a specialized loop passing tool, shown inFIGS. 70A-70B. InFIG. 70A,loop5112 of the suture S may be coupled to a passingtool5202 having a pointedtip5204. The tool may be used to pierce the labrum with a single, or twoholes5106,5108, and pass theloop5112 therethrough.Loop5112 is then released from passingtool5202.FIG. 70B illustrates aneedle5206 coupled toloop5112 of the suture S. The needle may be passed through the labrum along with the suture.Needle5206 may then be removed fromloop5112. Onceloop5112 is passed through labrum L, the anchor is passed through the loop and driven into the bone or inserted in a predrilled hole in the bone. Thefree end5110 may then be pulled in order to adjust suture length or tension.FIG. 69 further illustrates an alternative approach for capturing the labrum in which the suture is passed through the exposededge5114 of the labrum L which has been torn or cut from the acetabulum, rather than through the anterior face of the labrum. With this positioning of the suture, the labrum may be drawn directly into engagement with the acetabular rim with improved circumferential alignment between the labrum and acetabulum. Further, the sutures are exposed only on the outer side of the labrum so that there is no risk of engagement between the sutures and the femoral head as it moves.
FIG. 71 illustrates another exemplary embodiment of a suture anchor system utilizing only a single anchor. This embodiment is substantially similar to the embodiment illustrated inFIG. 67 above with eachend5304,5306 of suture S in its own cinching mechanism inanchor5302. However, in this embodiment, each cinching mechanism comprises a pair ofapertures5308a,5308bin the outer wall of the anchor through which the suture is threaded, like that illustrated inFIG. 46. After passing theloop5310 through the labrum L, passing the anchor through the loop, and deploying the anchor in the acetabulum, each of the free ends5304,5306 may be pulled in order to adjust suture length or tension.
Several exemplary methods of deploying suture anchors into tissue have been described above. However, this is not meant to be limiting. Other methods of deploying the anchor and re-attaching the damaged tissue to the substrate tissue may be used, such as those disclosed in U.S. Provisional Patent Applications and U.S. Patent Applications previously incorporated herein by references. Moreover, various other features such as anchor tip configurations, anchor coupling mechanisms, tissue capturing methods and suture cinching mechanisms have also been disclosed above and in references incorporated herein. One of skill in the art will appreciate that these features may be combined with one another or substituted for another and thus any number of combinations may be used.
While the above detailed description and figures are a complete description of the preferred embodiments of the invention, various alternatives, modifications, and equivalents may be used. The various features of the embodiments disclosed herein may be combined or substituted with one another. Therefore, the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.