US20150272567A1 - Devices, systems, and methods for attaching soft tissue to bone tissue - Google Patents

Abstract

A suture anchoring device for fixing a soft tissue to a bone tissue is disclosed that enables the exchange of sutures between anchors after implantation. The suture anchoring device may include a body that is inserted into the bone tissue, a suture exchange fitting situation within a passage formed within the body, and one or more pre-loaded sutures looped through the suture exchange fitting and projecting proximally from a proximal opening formed in the body. Surgical kits and surgical methods for performing various repair procedures using one or more suture anchoring device are also disclosed.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a continuation-in-part of PCT Application No. PCT/US2013/053524, with an international filing date of Aug. 3, 2013, entitled “SUTURE ANCHOR DEVICE AND METHODS OF USE,” and is hereby incorporated by reference in its entirety into the present application. PCT Application No. PCT/US2013/053524 claims priority to U.S. patent application Ser. No. 13/566,845 which was filed Aug. 3, 2012 and to U.S. provisional patent application 61/817,841 which was filed Apr. 30, 2013, each of which is hereby incorporated in its entirety into the present application.
• The present application also claims priority to U.S. provisional patent application No. 62/093,827 filed Dec. 18, 2014 entitled “DEVICES, SYSTEMS, AND METHODS FOR ATTACHING SOFT TISSUE TO BONE TISSUE;” U.S. provisional patent application No. 62/000,379, which was filed May 19, 2014, entitled “DOUBLE-LOOPED SUTURE;” and U.S. provisional patent application 61/949,485, which was filed Mar. 7, 2014, entitled “DOUBLE-LOOPED SUTURE.” All three provisional applications are hereby incorporated by reference in their entirety into the present application.
FIELD OF THE INVENTION
• The present invention generally relates to medical devices and to surgical implements. More particularly, preferred embodiments of the invention relate to suture anchor devices and methods for using the same.
BACKGROUND
• Soft tissue, such as tendons or ligaments, is typically displaced from its usual position in relation to the bone due to injury such as rupturing or tearing. Rotator cuffs, elbows, knees, ankles, and other joints are particularly prone to this type of injury. Injuries can be treated by attaching the soft tissue to the bone. Attaching soft tissue to bone may make use of suture anchors. Generally, a bone anchor with pre-loaded sutures is deployed into bone by inserting the anchor into an opening drilled into the bone. The pre-loaded sutures are used to attach the soft tissue to the bone by suture fixation techniques such as knot-tying, or by insertion of the suture into a knotless anchor for fixation.
• Surgical anchor repairs suffer risk of biomechanical failure. Reported failures include suture cutting through bone tunnels, suture breakage, knot slippage, suture anchor pull out, and soft tissue failure at the suture-tendon junction. There is a need for a suture anchor device and method of use that will lower the risk of such biomechanical failures.
SUMMARY OF THE INVENTION
• In one aspect, a tissue anchor is provided that includes a body and a flexible elongated element. The body may include a proximal end, a distal end opposite the proximal end, a proximal opening at the proximal end, a distal opening at the distal end, and a passage extending longitudinally through the body between the proximal and distal openings. The flexible elongated element may at least contribute to the defining of an aperture that opens in a direction substantially perpendicular to a longitudinal axis of the passage. The flexible elongated element may be secured to the body at first and second spaced-apart locations to facilitate the aperture being maintained in an open condition. The first and second spaced-apart locations may include a first side of the passage and a second side of the passage opposite the first side of the passage. The flexible elongated element may be secured to the each side of the passage via a ring, hook or loop. The body may further include a distal tip that may be at least one of received or configured to be received in the distal opening. The first and second spaced-apart locations may include a first side of the distal tip and a second side of the distal tip opposite the first side of the distal tip. The body may further include a distal tip that may be at least one of received or configured to be received in the distal opening. The flexible elongated element may include a first tail and a second tail spaced-apart from the first tail by the first tail and the second tail respectively intersecting the distal tip at the first and second spaced-apart locations thereby facilitating the aperture being maintained in the open condition. When the distal tip is received in the distal opening, the aperture may be located in the passage proximal the distal tip. The distal tip may include a molded material; a distal region of the first tail and a distal region of the second tail may be molded into the molded material at the first and second spaced-apart locations. The distal tip may be configured such that implantation forces exerted on the distal tip may enhance the extent to which the distal tip may be received in the distal opening. The first and second spaced-apart locations respectively may include first and second spaced-apart channels in the distal tip, and a distal region of the first tail and a distal region of the second tail may be respectively located in the first and second spaced-apart channels. The first spaced-apart channel may include a groove defined in an outer surface of the distal tip and the distal region of the first tail may extend through the groove, which may open against an inner wall surface defining the passage when the distal tip is received in the distal opening. The first spaced-apart channel may include a lumen defined in the distal tip and the distal region of the first tail may extend through the lumen. The first and second tails may be distally joined together via a knot. The knot may be coated or impregnated with a polymer, epoxy or adhesive. The first and second tails may be part of a continuous loop of the flexible elongated element. The first and second tails may extend into each other in a continuous manner. The first and second tails may be distally joined together via a joining member extending about the at least portions of the first and second tails. The joining member may be at least one of crimped or molded onto the first and second tails. The distal tip may include a distal recess in which the joining member may be seated. The distal tip may include a proximal shaft opposite the distal recess, the distal tip being received in the distal opening on account of the proximal shaft being received in the distal opening and residing in the passage. The proximal shaft may form an interference fit with at least one of the distal opening or the passage. The first and second spaced-apart channels may extend longitudinally along the proximal shaft. The aperture may be defined between the flexible elongated element and a proximal end of the proximal shaft of the distal tip. A maximum height of the aperture in a non-deflected state and extending parallel to the longitudinal axis of the passage may be defined between the flexible elongated element and a proximal end of the distal tip. The maximum height of the aperture may be between a height of the proximal end of the tissue anchor and a height of the proximal end of the body plus a thickness of a soft tissue. The soft tissue may be proximal to the proximal end of the body. A maximum width of the aperture in a non-deflected state may be defined between the first and second spaced-apart locations, and the maximum width of the aperture may be approximately the maximum width of the passage. The maximum width of the aperture may extend perpendicular to the longitudinal axis of the passage. A most proximal extent of the flexible elongated element in a non-deflected state may be recessed distally within the passage from the proximal opening up to approximately a thickness of a suture mass to be passed through the aperture. The proximal opening may be configured to interface with an insertion tool. The flexible elongated element may include a suture. The suture may be a braided suture formed of a material that may include polyethylene. The material may further include a thickness of between approximately 0.008″ and approximately 0.045″. The suture may be at least one of heat treated, coated or impregnated to at least one of stiffen or shape the suture. The flexible elongated element may include a wire or monofilament. The flexible elongated element may extend through a sheath. The flexible elongated element may extend along a U-shaped channel member. A segment of polymer or metal may extend through a lumen of the flexible elongated element. A loop may encircle a portion of the distal tip and the loop may include the flexible elongated element. The aperture may be defined between the flexible elongated element and a proximal end of the distal tip. The loop may further include a joining member joining together the first and second tails of the flexible elongated element. The joining member may be received in a distal recess of the distal tip.
• In this one aspect, the tissue anchor may be a result of an assembly process. The assembly process may include: a) assembling a tip assembly by causing a loop to encircle a portion of the distal tip; and b) causing the tip assembly to be received in the distal opening of the body. The loop may include the flexible elongated element. The loop may further include a joining member joining together the first and second tails of the flexible elongated element, and the joining member may be received in a distal recess of the distal tip as part of assembling the tip assembly.
• In this one aspect, the body may further include a thread helically extending about an exterior of the body. The thread may include a double helix thread; the double helix thread may include two distinct threads offset approximately 180 degrees from each other. The aperture may have a minimum width to height ratio of three to one and a maximum width to height ratio of one to ten. The flexible elongated element may be configured to flex in a twisting rotation manner such that the aperture can accommodate different suture exchange attack angles. The flexible elongated element may be configured to flex in a twisting rotation manner such that a direction in which the aperture opens when the flexible elongated element is at maximum twisted rotation may be between approximately 90 degrees and approximately 360 degrees from the direction in which the aperture opens when the flexible elongated element is in a non-deflected state. The flexible elongated element may be configured to maintain the aperture sufficiently open to accommodate suture exchange despite being at the maximum twisted rotation. The flexible elongated element may be configured to flex in a twisting rotation manner such that the aperture has no angles that are tighter than approximately 90 degrees when the flexible elongated element is at a twisted rotation of up to approximately 90 degrees from the direction in which the aperture opens when the flexible elongated element is in a non-deflected state. The aperture may be configured to accommodate a minimum mass throughput of 4 sutures.
• In another aspect, a surgical kit is provided that may include: the tissue anchor described herein, a suture, and instructions. The body of the tissue anchor may further include a distal tip that may be at least one of received or configured to be received in the distal opening. The flexible elongated element may include a first tail and a second tail spaced-apart from the first tail by the first tail and the second tail respectively intersecting the distal tip at the first and second spaced-apart locations thereby facilitating the aperture being maintained in the open condition. The suture may include a first end and a second end opposite the first end. The instructions may provide that, with the suture first extending through the aperture, the distal tip may be caused to be received in the distal opening such that the suture may extend through the passage and out the proximal opening such that the first and second ends of the suture are proximal the proximal opening. The suture may further include a loop at at least one of the first end or the second end of the suture. The loop may be the result of a bifurcation of the suture or the loop may be a result of the suture being folded back on itself and adhered to itself.
• In this other aspect, the surgical kit may further include a delivery device. The delivery device may include a distal end, a proximal end opposite the distal end, and a lumen extending between the distal and proximal ends of the delivery device. The distal end of the delivery device may include a feature for coupling with and transmitting a torque to the proximal end of the body. The instructions may further provide that, once the distal tip is received in the distal opening such that the suture extends through the passage and out the proximal opening such that the first and second ends of the suture are proximal the proximal opening, the suture may be further caused to extend through the lumen such that the first and second ends of the suture extend from the proximal end of the delivery device and the distal end of the delivery device may be engaged with the proximal end of the body. The instructions may be provided via at least one of: on packaging enclosing at least some of the surgical kit; in packaging enclosing at least some of the surgical kit; accompanying the surgical kit; an electronic communication; or an internet website.
• In another additional aspect, a method of anchoring soft tissue to bone via a first tissue anchor including a body including a proximal opening, a distal opening, a passage extending between the proximal and distal openings, and a distal tip configured to be received in the distal opening is provided. The distal tip may be loaded with a first suture such that the first suture extends through an aperture of the distal tip. In this other additional aspect, the method may include: causing the distal tip loaded with the first suture to be received in the distal opening of the body such that the first suture extends through the passage of the body and out the proximal opening such that the first and second ends of the first suture are proximal the proximal opening. Once the distal tip is received in the distal opening such that the first suture extends through the passage and out the proximal opening such that the first and second ends of the first suture are proximal the proximal opening, the first suture may be further caused to extend through a lumen of a delivery device such that the first and second ends of the first suture extend from a proximal end of the delivery device and a distal end of the delivery device is engaged with a proximal end of the body. The lumen may extend between a distal end of the delivery device and the proximal end of the delivery device. The method may further include using the delivery device to torque the first tissue anchor into the bone. The method may further include implanting the first tissue anchor into the bone with the suture loaded distal tip received in the distal opening. The method may further include: a) extending the first and second ends of the first suture through the soft tissue; b) after step a), causing a second suture to extend through a loop defined in the first suture near the first end of the first suture or between the first and second ends of the first suture; and c) after step b), pulling on the second end of the first suture to draw the second suture through the soft tissue and down into the implanted first tissue anchor and through the aperture such that the second suture extends through the passage of the body and out the proximal opening such that first and second ends of the second suture are proximal the proximal opening and extend through the soft tissue. The second suture may extend through the soft tissue from a second tissue anchor implanted in the bone prior to being caused to pass again through the soft tissue at another location and down into the first tissue anchor as recited in step c). The second suture at the completion of step c) may extend from the first end of the second suture through the soft tissue, into and out of the implanted second tissue anchor, through the soft tissue, back into the soft tissue, into and out of the implanted first tissue anchor, and through the soft tissue to the second end of the second suture. The method may further include: a) causing a second suture to extend through a loop defined in the first suture near the first end of the first suture or between the first and second ends of the first suture; b) after step a), pulling on the second end of the first suture to draw the second suture down into the implanted first tissue anchor and through the aperture such that the second suture extends through the passage of the body and out the proximal opening such that first and second ends of the second suture are proximal the proximal opening; and c) after step b) extending the first and second ends of the second suture through the soft tissue. The second suture may extend from a second tissue anchor implanted in the bone prior to being caused to pass down into the first tissue anchor as recited in step b). The second suture at the completion of step c) may extend from the first end of the second suture through the soft tissue, into and out of the implanted second tissue anchor, through the soft tissue, back into the soft tissue, into and out of the implanted first tissue anchor, and through the soft tissue to the second end of the second suture.
• While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosure. As will be realized, the invention is capable of modifications in various aspects, all without departing from the spirit and scope of the present disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.
BRIEF DESCRIPTION OF THE FIGURES
• The following figures describe various aspects of the disclosure.
• FIG. 1 is a side view of a tissue anchor device.
• FIG. 2 is a cross-sectional side view of a tissue anchor device.
• FIG. 3 is a transparent side view of a tissue anchor device.
• FIG. 4 is a top perspective view of a tissue anchor device.
• FIG. 5 is a side view of a tissue anchor device with a suture exchange fitting at the proximal end of the body.
• FIG. 6 is a perspective cutaway view of a single-piece tissue anchor device with a suture exchange fitting and sutures.
• FIG. 7 is an exploded view of a tissue anchor device.
• FIG. 8 is a cross-sectional side view of a tissue anchor device.
• FIG. 9 is a side view of a tissue anchor device with a separate distal tip.
• FIG. 10 is a side view of a suture exchange fitting in an opened configuration.
• FIG. 11 is a side view of a suture exchange fitting in a collapsed configuration.
• FIG. 12 is a side view of a distal end and a twisted exchange ring of a suture exchange fitting.
• FIG. 13 is a top view of a distal end and a twisted exchange ring of a suture exchange fitting.
• FIG. 14 is a side view of a distal end and a suture exchange fitting with a short exchange ring.
• FIG. 15 is a side view of a distal end and a suture exchange fitting with a long exchange ring.
• FIG. 16 is a side view of a suture exchange fitting in an opened configuration with several sutures within the exchange ring.
• FIG. 17 is a cross-sectional side view of a tissue anchor device with support loops attached to the inner wall defining the passage.
• FIG. 18 is a top perspective view of a distal tip with a first channel at a first side and a second channel at a second side of the distal tip.
• FIG. 19 is a cross-sectional side view of a tissue anchor device with an exchange ring formed from a single flexible strand with opposed ends secured between the distal end of the body and the proximal end of the distal tip.
• FIG. 20 is a top perspective view of a distal tip with an exchange ring formed from a single flexible strand with opposed ends attached to a proximal face of the distal tip.
• FIG. 21 is a cross-sectional side view of a tissue anchor device with an exchange ring formed from a single flexible strand reinforced by a braided sheath.
• FIG. 22 is a cross-sectional side view of a tissue anchor device with an exchange ring formed from a single flexible strand reinforced by a U-shaped reinforcing element.
• FIG. 23 is a cross-sectional side view of a tissue anchor device with an exchange ring formed from a single flexible strand reinforced by an internal reinforcing element.
• FIG. 24 is a side view of a U-shaped reinforcing element with a defect configured to enable the collapse of the exchange ring under a collapsing load.
• FIG. 25 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a clip collapsed by an upward pull at greater than the collapsing force.
• FIG. 26 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a clip collapsed by a downward push at greater than the collapsing force.
• FIG. 27 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a rigid ring.
• FIG. 28 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a bearing.
• FIG. 29 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a disk-shaped bearing.
• FIG. 30 is a cross-sectional side view of a tissue anchor device with an exchange ring formed as a ring with a transverse bar.
• FIG. 31 is a top view of an exchange ring formed as a ring with a transverse bar.
• FIG. 32 is a cross-sectional side view of a tissue anchor device with an exchange ring attached to a shaft with at least one bearing further attached to the shaft.
• FIG. 33 is a perspective view of a distal tip with a proximal groove and a transverse bar forming a suture exchange fitting.
• FIG. 34 is a perspective view of a body of a tissue anchor device with a proximal groove and a transverse bar forming a suture exchange fitting.
• FIG. 35 is a cross-sectional side view of a tissue anchor device with an exchange ring attached to a ball.
• FIG. 36 is a side view of a double-looped suture.
• FIG. 37 is a side view of threading a first suture end through a second suture end during a suture exchange.
• FIG. 38 is a side view of pulling a first suture end and attached second suture end during a suture exchange.
• FIG. 39 is a top view of a suture loop formed from a bifurcation of a suture.
• FIG. 40 is a block diagram summarizing elements of a surgical kit.
• FIG. 41 is a flow chart summarizing a method of attaching a soft tissue to a bone using at least one tissue anchor device.
• FIG. 42A,FIG. 42B,FIG. 42C,FIG. 42D,FIG. 42E, andFIG. 42F are schematic diagrams illustrating a single row repair using at least one tissue anchor device.
• FIG. 43A,FIG. 43B,FIG. 43C,FIG. 43D,FIG. 43E,FIG. 43F, andFIG. 43G are schematic diagrams illustrating a wide single row repair using at least one tissue anchor device.
• FIG. 44A,FIG. 44B,FIG. 44C,FIG. 44D,FIG. 44E,FIG. 44F, andFIG. 44G are schematic diagrams illustrating a double row repair using at least one single-loaded tissue anchor device.
• FIG. 45A,FIG. 45B,FIG. 45C,FIG. 45D,FIG. 45E,FIG. 45F, andFIG. 45G are schematic diagrams illustrating a double row repair using at least one double-loaded tissue anchor device.
• FIG. 46A,FIG. 46B,FIG. 46C,FIG. 46D,FIG. 46E,FIG. 46F, andFIG. 46G are schematic diagrams illustrating a transosseous double row repair using at least one double-loaded tissue anchor device.
• FIG. 47A andFIG. 47B are schematic diagrams illustrating knotless fixation methods for double-row repairs using at least one single-loaded or double-loaded tissue anchor device.
• FIG. 48A,FIG. 48B,FIG. 48C,FIG. 48D,FIG. 48E, andFIG. 48F are schematic diagrams illustrating alternative double row repairs using at least one single-loaded or double-loaded tissue anchor device.
• FIG. 49A,FIG. 49B,FIG. 49C,FIG. 49D,FIG. 49E,FIG. 49F,FIG. 49G,FIG. 49H,FIG. 49I, andFIG. 48J are schematic diagrams illustrating a labrum repair using at least one single-loaded or double-loaded tissue anchor device.
• FIG. 50A,FIG. 50B andFIG. 50C are cutaway views of a tissue anchor device that includes a free-swiveling exchange ring.
• Corresponding reference characters and labels indicate corresponding elements among the views of the drawings. The headings used in the figures should not be interpreted to limit the scope of the claims.
DETAILED DESCRIPTION
• In various aspects, a suture anchor device is provided herein for the attachment of soft tissues to bone. The suture anchor device may include a body which is inserted into bone tissue. The suture anchor device may further include a suture exchange fitting situated within a passage formed in the body. The suture exchange fitting may enable one or more repair sutures to be shuttled or exchanged through the suture anchor device after the body has been implanted in bone. The sutures may be looped at one or both ends; each loop may reversibly trap an end of a second suture, and the loop may pull the second suture through a suture exchange fitting and/or a soft tissue during a suture exchange. The suture exchange fitting may be further configured to collapse if subjected to a sufficiently high suture pulling force, thereby locking in any sutures present within the suture exchange fitting.
• In various other aspects, a surgical kit is provided herein that may include the suture anchor device, instructions for the use of the suture anchor device, and an insertion tool or implanting the suture anchor device in the bone tissue of a subject. In other additional aspects, a method of anchoring a soft tissue to a bone using one or more tissue anchors is provided herein.
I. Tissue Anchor
• One embodiment disclosed herein includes a tissue anchor that may be inserted into bone tissue to which a soft tissue is to be attached using one or more sutures in a variety of suture patterns and/or arrangements. In various aspects, the tissue anchor may include one or more suture loading features to enable the loading of one or more sutures into the tissue anchor device after deployment of the tissue anchor into the bone tissue. These one or more suture loading features may further enable the exchange of sutures between one or more additional tissue anchor deployed at other locations within the bone tissue. The one or more tissue anchors may provide robust anchor points for the secure attachment of an overlying soft tissue including, but not limited to, a tendon or ligament to the underlying bone tissue. In various other aspects, additional features of the tissue anchor as disclosed herein may facilitate suture exchange by reducing pull-through forces, may inhibit anchor pullout, and/or may reduce the likelihood of suture failure due to suture breakage, knot failure, and the like.
• FIG. 1 is a side view of atissue anchor100 in an aspect. Thetissue anchor100 may include abody102 with aproximal end104 and adistal end106 opposite to theproximal end104. Theproximal end104 may include aproximal opening108 configured to receive one ormore sutures110. In use, thedistal end106 of thetissue anchor100 may be advanced into a bone tissue (not shown) using an insertion tool (not shown) reversibly attached at theproximal end104 of thetissue anchor100. In an aspect, theouter surface112 of thetissue anchor100 may include anexternal thread114 to facilitate the insertion of thetissue anchor100 into the bone tissue.
• FIG. 2 is a longitudinal cross-section of thetissue anchor100 in an aspect. The one ormore sutures110 may be retained within apassage116 extending from theproximal opening108 toward thedistal end106 along alongitudinal axis118 of thepassage116. Eachsuture110 may pass through anaperture302 within a suture exchange fitting300 situated within thepassage116. In an aspect, the suture exchange fitting300 may be recessed distally within thepassage116 relative to theproximal opening108. In another aspect, thepassage116 andaperture302 may be sized to permit a sliding motion of the one ormore sutures110 through the suture exchange fitting300 to enable the exchange of suture in and out of thetissue anchor100 and between two ormore tissue anchor100 using a sufficiently low pulling force as described herein below.
• Thetissue anchor device100, including various features of thebody102 and suture exchange fitting300 are described in detail herein below.
• a. Body
• Referring again toFIG. 1, thetissue anchor device100 includes abody102 with aproximal end104 and adistal end106. In various aspects, thebody102 may be inserted into bone tissue to provide a robust anchor for one or more sutures used to attach a soft tissue including, but not limited to, a tendon or ligament to the bone tissue. As such, the external shape of thebody102 may be an elongated cylindrical profile similar to the external profile of known orthopedic fasteners including, but not limited to, bone screws.
• In various aspects, thebody102 may have anouter diameter124 ranging from about 2 mm to about 8 mm. Theouter diameter124 of thebody102 may depend on any one or more factors including, but not limited to: the accessible area of bone tissue within which thetissue anchor device100 is to be inserted, the desired anchoring strength of thetissue anchor device100, and the size and number of sutures to be anchored by thetissue anchor device100. Largerouter diameters124 may be selected for applications requiring higher anchoring strength. Further, largerouter diameters124 may be selected for anchoring large diameter sutures and/or multiple sutures. In various other aspects, the outer diameter124 may range from about 2 mm to about 2.2 mm, from about 2.1 mm to about 2.3 mm, from about 2.2 mm to about 2.4 mm, from about 2.3 mm to about 2.5 mm, from about 2.4 mm to about 2.6 mm, from about 2.5 mm to about 2.7 mm, from about 2.6 mm to about 2.8 mm, from about 2.7 mm to about 2.9 mm, from about 2.8 mm to about 3.0 mm, from about 2.9 mm to about 3.1 mm, from about 3.0 mm to about 3.2 mm, from about 3.1 mm to about 3.3 mm, from about 3.2 mm to about 3.4 mm, from about 3.3 mm to about 3.5 mm, from about 3.4 mm to about 3.8 mm, from about 3.6 mm to about 4.0 mm, from about 3.8 mm to about 4.2 mm, from about 4 mm to about 4.4 mm, from about 4.2 mm to about 4.6 mm, from about 4.4 mm to about 4.8 mm, from about 4.6 mm to about 5.0 mm, from about 4.8 mm to about 5.25 mm, from about 5.0 mm to about 5.5 mm, from about 5.25 mm to about 5.75 mm, from about 5.5 mm to about 6.0 mm, from about 5.75 mm to about 6.25 mm, from about 6.0 mm to about 6.5 mm, from about 6.25 mm to about 6.75 mm, from about 6.5 mm to about 7.0 mm, from about 6.75 mm to about 7.25 mm, from about 7 mm to about 7.5 mm, from about 7.25 mm to about 7.75 mm, or from about 7.5 mm to about 8 mm.
• In various other aspects, thebody102 may have alength126 ranging from about 5 mm to about 50 mm. Thelength126 may vary in proportion to the outer diameter of thebody102. In various aspects, the ratio of thelength126 to theouter diameter124 of thebody102 may be 0.5:1, 1:1, 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 6:1, 8:1, or 10:1. In various additional aspects, thelength126 of thebody102 may range from about 5 mm to about 10 mm, from about 7.5 mm to about 12.5 mm, from about 10 mm to about 15 mm, from about 12.5 mm to about 17.5 mm, from about 15 mm to about 20 mm, from about 17.5 mm to about 22.5 mm, from about 20 mm to about 30 mm, from about 25 mm to about 35 mm, from about 30 mm to about 40 mm, from about 35 mm to about 45 mm, and from about 40 mm to about 50 mm.
• 1. External Threads
• Referring again toFIG. 1, thebody102 may further include at least one external feature to facilitate the implantation of thetissue anchor device100 into the bone tissue, and to enhance the anchor strength of thetissue anchor device100 during long-term use. Any known external feature suitable for orthopedic anchor devices may be formed on thebody102 including, but not limited to: one or more circumferential rings typical of push-in suture anchors, and one ormore threads114 helically extending about an exterior of thebody102 as illustrated inFIG. 1. In one aspect, the external feature may be one ormore threads114 extending along at least a portion of thelength126 of thebody102. The one ormore threads114 may have any configuration suitable for use in an orthopedic anchoring device including, but not limited to: single threads with a constant thread pitch, single threads with a variable pitch, self-tapping threads, and double-helix threads.
• FIG. 3 is a transparent side view of atissue anchor device100 with a double helix thread in one aspect. As illustrated inFIG. 3, the double helix thread includes afirst thread114A and asecond thread114B; boththreads114A/114B may start at theproximal end104 oriented about 180° from one another. In this aspect, thedouble helix threads114A/14B may enable a relatively high thread density, which may enhance bone fixation of thetissue anchor device100, while maintaining a relatively high thread pitch, which may reduce the number of turns associated with driving thetissue anchor device100 into the bone tissue. Compared to a double helix thread, a single helix thread may have a lower thread pitch to enable an equivalent thread density, and as a result may drive thetissue anchor device100 into the bone tissue with a higher number of turns during implantation.
• 2. Distal End
• Referring again toFIG. 1, thedistal end106 of thebody102 may be configured to facilitate the implantation of thetissue anchor device100. Referring again toFIG. 2, thedistal end106 of thebody102 may further include a lead-in130 in one aspect. The lead-in130 may be tapered at thedistal end106 and may further be non-threaded. The profile of the lead-in130 may be any suitable profile including, but not limited to: a conical profile, a spherical profile, a pointed profile, and any other suitable profile.
• In one aspect, thebody102 may be a solid body with no internal passage, lumen, or the like. In this aspect, a suture exchange fitting300 may be formed in other configurations, such as an eyelet formed in thesolid body102 for receiving multiple thicknesses or strands of a suture. In this aspect, thebody102 may include a suture exchange fitting300 attached to theproximal end104 of thebody102, as illustrated inFIG. 5. In other aspects, the suture exchange fitting300 may be attached at any other location on thesolid body102 without limitation. In yet other aspects, the suture exchange fitting300 may include one or more bores (not shown) formed through thesolid body102 at any location on thebody102 without limitation.
• 3. Interior Passage
• In another aspect, illustrated inFIG. 2, thebody102 may further include aninterior passage116 extending from theproximal opening108 toward thedistal end106 for at least a portion of thelength126 of thebody102. In various aspects, thepassage116 may have aninner diameter128 ranging from about 1 mm to about 6 mm. Theinner diameter128 may be selected to maintain a minimum material thickness throughout thebody102 to maintain the structural integrity of thetissue anchor device100 during implantation and long-term use. In addition, the inner diameter may further be selected to provide sufficient space to exchange one ormore sutures110 with suitably low pulling resistance and/or to maintain a sufficientlylarge aperture302 of the suture exchange fitting300 for suture exchange.
• In various aspects, the ratio of theinner diameter128 to theouter diameter124 of thebody102 may be about 1:10, about 1:9, about 1:8, about 1:7, about 1:6, about 1:5, about 1:4, about 1:3, about 1:2, about 1:1.5, and about 1:1.2. In various aspects, thepassage116 may have aninner diameter128 ranging from about 1 mm to about 2 mm, from about 1.5 mm to about 2.5 mm, from about 2 mm to about 3 mm, from about 2.5 mm to about 3.5 mm, from about 3 mm to about 4 mm, from about 3.5 mm to about 4.5 mm, from about 4 mm to about 5 mm, from about 4.5 mm to about 5.5 mm, and from about 5 mm to about 6 mm.
• In an aspect, theinner diameter128 of thepassage116 may be sufficiently large to accommodate the width and the minimum mass width of thesutures110 loaded into thetissue anchor device100. The minimum mass width of thesutures110, as used herein, refers to the width of double the number of sutures present in thetissue anchor device100, and allows for the additional widths of any sutures that may be exchanged from an additionaltissue anchor device100. By way of non-limiting example, the mass width of thesutures110 for a triple loadedtissue anchor device100 may be 3sutures110, each looped through theaperture302, for a total suture mass equal to the collective width of sixsutures110. An exchanged suture would result in anadditional suture110 being exchanged or pulled through theaperture302, and this exchangedsuture110 may also fold over or otherwise represent a mass of double its single strand width during the suture exchange.
• As described in detail herein below, the suture exchange may involve a pull of a first suture that is threaded through theaperture302 and may further involve linking to a second suture that is also threaded through theaperture302; the first and second suture may each contribute two ends that extend proximally from theaperture302 through thepassage116, resulting in four lengths of suture occupying thepassage116 during a suture exchange, because each of the sutures is folded within thebody102 of thetissue anchor device100. In various other aspects, theinner diameter128 of thebody102 may be sufficiently large to accommodate the width and the minimum mass width of one (single loaded) #2 suture, 2 (double loaded) #2 sutures, or three (triple loaded) #2 sutures, combined with the added width of an exchanged #2 suture from a nearby anchor. In all cases, the minimum width must accommodate the loaded width and exchange width equal to twice the individual width of a #2 suture.
• In various aspects, theinner diameter128 of thepassage116 may be sized to reduce the pulling friction as one ormore sutures110 are pulled through theaperture302 within thepassage116. In other aspects, the passage may further include additional features to reduce pulling friction. In one aspect, thepassage116 may be configured to avoid the inclusion of potential pinch points and/or friction points that may impede suture exchange, catch a suture during a suture exchange, and/or otherwise reduce suture exchange efficiency. In one non-limiting example, illustrated inFIG. 2, theinner wall120 defining thepassage116 may be formed as a continuously smooth surface with no abrupt transitions between regions of thepassage116 that may result in sharp edges against which asuture110 may rub. In another non-limiting example, theproximal opening108 may include achamfer136 to reduce the sharpness of the lip surrounding theproximal opening108.
• Referring again toFIG. 5, the suture exchange fitting300 may protrude proximally from theproximal end104 of thebody102 in an aspect. In this one aspect, thepassage116 need not accommodate the sliding of one ormore sutures110, because theaperture302 is not situated within thepassage116. In this aspect, theinner diameter128 may be reduced to less than the width and/or the minimum mass width of two ormore sutures110 within thebody102. However, this arrangement of the suture exchange fitting300 at theproximal end104 of thebody102 may result in contact between theaperture302 and the soft tissue contacting the surface of the bone above theproximal end104 of the tissue anchor device; this contact may lead to increased friction between theaperture302 and the one ormore sutures110 during a suture exchange, and/or irritation and/or inflammation of the soft tissue that may prolong healing of the soft tissue. To reduce the contact between theaperture302 and the soft tissue, thebody102 may be sufficiently counter-sunk into the bone tissue to situate theaperture302 below the bone surface. However, the overlap between the bone anchor and the rigid cortical bone may be reduced by this countersinking thereby reducing the overall fixation strength of the anchor.
• 4. Tool Fitting and Vent Holes
• In various aspects, theproximal end104 of thebody102 may be configured to engage one or more tools used to implant thetissue anchor device100 within the bone tissue.FIG. 4 is a top perspective view of abody102 showing theproximal opening108. In an aspect, the proximal opening may include a tool fitting134 configured to receive a tool (not shown) used to insert thebody102 into the bone tissue. The tool fitting134 may be configured to receive any suitable orthopedic insertion tool including, but not limited to, a torsional driver, an impact tool such as a slap hammer or impact hammer, and any other suitable tool. The tool fitting134 may have any suitable profile corresponding to an orthopedic anchor insertion tool including, but not limited to: single-blade screwdriver, a cruciform driver, a Phillips-head screwdriver, a star-head driver, a hexagonal driver as illustrated inFIG. 4, and any other suitable tool fitting profile. In another aspect, the tool fitting134 may include a chamfer136 (seeFIG. 4), fillet or other feature at the entry point of the tool fitting134 to facilitate the insertion of the implantation tool into theproximal end104 of thebody102.
• Referring again toFIG. 1, thebody102 may further include additional features to enhance the healing of the bone tissue in the vicinity of the implantedtissue anchor device100 and/or to enhance the adhesion or integration of bone tissue into the external surface of thebody102. In one aspect, thebody102 may include one or more vent holes132 extending from the exterior surface of thebody102 into thepassage116 within thebody102. In this aspect, the one or more vent holes132 may facilitate the migration of red blood cells and other cells and biofluids into thebody102 and may further facilitate contact of these cells and biofluids with the bottom surface of the soft tissue adjacent to the bone tissue, thereby promoting healing. In another aspect (not shown) the exterior surface of thebody102 may further include one or more depressions including, but not limited to dimples, blind bores, and/or indentations. In this other aspect, the one or more depressions may enhance the contact area of thebody102 with the surrounding bone tissue. In addition, the one or more depressions may be filled with one or more bioactive substances to promote healing of the bone tissue and overlying soft tissue. Non-limiting examples of suitable bioactive substances include: anti-inflammatory compounds, antibiotics, immunosuppressant compounds, and/or tissue growth stimulants such as bone growth factor.
• In various aspects, thebody102 may be formed using any suitable biocompatible material of sufficient strength without limitation. In various aspects, any one or more known materials for orthopedic fasteners may be used to construct thebody102 including, but not limited to: metals and alloys including stainless steel, titanium, and titanium alloys, and biocompatible plastics and polymers such as PEEK. In one aspect, thebody102 may be constructed of a single material. In another aspect, thebody102 may be a composite structure composed of two or more materials.
• b. Distal Tip
• Referring toFIG. 6, thebody102 may be provided as a single segment extending from theproximal end104 to thedistal end106 in one aspect. In this aspect, thedistal end106 may include adistal opening138 through which a suture exchange fitting300 may be inserted. In other aspects, thetissue anchor device100 may further include adistal tip200 in addition to thebody102. In these other aspects, thedistal tip200 may be received and/or may be configured to be received in thedistal opening138 of thebody102. The two-piece design of these other aspects may facilitate the assembly of thetissue anchor device100.
• 1. Proximal Shaft
• FIG. 7 is an exploded view of atissue anchor device100 that includes thebody102 anddistal tip200 in an aspect. In this aspect, thedistal tip200 may include aproximal shaft202 protruding in a proximal direction. Theproximal shaft202 may be configured to fit within thedistal opening138 of the body. In another aspect, thedistal tip200 may further include aflange204 with an outer diameter that is larger than the diameter of thedistal opening138, thereby providing a mechanical stop to limit the degree of insertion of theproximal shaft202 into thedistal opening138. In this other aspect, thebody102 may be further provided with adistal face140 against which theflange204 of thedistal tip200 may press when thebody102 anddistal tip200 are assembled to form thetissue anchor device100 as illustrated inFIG. 8. In this aspect, the outer diameter of theflange204 may be essentially matched to the outer diameter of thedistal end106 of thebody102, such that thebody102 andistal end200 form a relatively smooth profile when assembled, as illustrated inFIG. 9. In yet another aspect, thepassage116 within the body may include astep142 which has a smaller dimension than theproximal shaft202, within thepassage116 inside thebody102 may also serve to stop thedistal tip200 from sliding into thebody102.
• Referring again toFIG. 8, theproximal shaft202 of thedistal tip200 may be press-fit into thedistal opening138 of thebody102. Without being limited to any particular theory, the forces on thetissue anchor device100 are typically applied in a proximal direction along thelongitudinal axis118 of thetissue anchor device100. Loads may be applied to thedistal tip200 and may serve to further seat theproximal shaft202 within thedistal opening138 of thebody102, thereby maintaining a secure coupling between thedistal tip200 and thebody102 without the addition of any other materials or processing. In one aspect, the coupling between thedistal tip200 and thebody102 may be a force fit or a friction fit. In other aspects, an adhesive or other biocompatible bonding agent or bonding process may be used to maintain or improve the coupling between thedistal tip200 and thebody102.
• Referring again toFIG. 7, thedistal tip200 and thebody102 of thedistal opening138 may further include mechanical elements (not shown) to maintain or improve the coupling between thedistal tip200 and thebody102. Any known interlocking mechanical elements may be incorporated into thedistal tip200 andbody102 including, but not limited to, roughened surface textures, additional elements such as compression washers and the like, and interlocking mechanical elements such as meshing threads. In one aspect, theouter surface210 of theproximal shaft202 and receivingsurface144 of thedistal opening138 may include surface roughening (not shown). In another aspect, a compression washer or washer with a roughened texture (not shown) may be inserted over theproximal tip202 prior to assembly of thetissue anchor device100. In an additional aspect, theouter surface210 of theproximal shaft202 may include a threaded portion (not shown) that may intermesh with a threaded receptacle (not shown) formed on the receivingsurface144 of thedistal opening138; thedistal tip200 may be rotated to advance the threaded portion into the threaded receptacle of thedistal opening138. In another additional aspect, theouter surface210 of theproximal shaft202 may include one or more tabs or protrusions (not shown) that may intermesh with one or more tracks or slots (not shown) formed on the receivingsurface144 of thedistal opening138. In this other additional aspect, the distal tip may be advanced into thedistal opening138 with the one or more tabs or protrusions upon theouter surface210 of theproximal shaft202 aligned with one or more gaps (not shown) formed in the one or more tracks or slots on the receivingsurface144; thedistal tip200 may then be rotated a partial turn up to about45 degrees to advance the tabs or protrusions of thedistal tip200 into the tracks or slots of thedistal opening138, thereby locking thedistal tip200 in place.
• In various aspects, thedistal tip200 may be formed using any suitable biocompatible material of sufficient strength without limitation. In various aspects, any one or more known materials for orthopedic fasteners may be used to construct thedistal tip200 including, but not limited to: metals and alloys including stainless steel, titanium, and titanium alloys, and biocompatible plastics and polymers such as PEEK. In one aspect, thedistal tip200 may be constructed of a single material. In another aspect, thedistal tip200 may be a composite structure composed of two or more materials. In yet another aspect, thedistal tip200 andbody102 may be constructed of similar metal compositions to prevent oxidation-reduction reactions between thebody102 anddistal tip200 that may degrade one or both components over long-term use.
• 2. Retention Features for Suture Exchange Fitting
• Referring again toFIG. 8, thedistal tip200 may further include one or more additional features to retain the suture exchange fitting300 at a desired position and to further maintain theaperture302 of the suture exchange fitting300 in an open position to facilitate the exchange of sutures within theaperture302. By way of non-limiting example, these additional features may include adistal recess206 formed within thedistal end208 of thedistal tip200 to secure the suture exchange fitting300 in a fixed position near thedistal end106 of thebody102. Various aspects of additional features of thedistal tip200, as well as thebody102, to retain the suture exchange fitting300 are described in detail herein below.
• c. Suture Exchange Fitting
• Referring again toFIG. 2, thetissue anchor device100 may further include a suture exchange fitting300 with anaperture302 in various aspects. Theaperture302 may enable repair sutures to be shuttled or exchanged through thebody102 of thetissue anchor device100 after thetissue anchor device100 has been implanted in bone tissue and may further enable the repair sutures to be passed through soft tissue in one aspect. In another aspect, theaperture302 may be configured to remain fully open during each suture exchange, thereby maintaining the suture friction and associated suture pulling force at acceptably low levels. Without being limited to any particular theory, a relatively high suture friction and/or suture pulling force may degrade the effectiveness of thetissue anchor device100 due to reduction in surgical tactile feel during suture exchange and/or an inability to execute the pull-through of sutures due to increased suture pulling forces. In another aspect, theaperture302 of the suture exchange fitting300 may be configured to close or collapse once the load or tension applied to the repair sutures exceed a particular threshold collapsing force, thereby preventing further suture exchanges.
• During suture exchange and the initial passage of one or more repair sutures110 through the soft tissue, theaperture302 may maintain a space sufficiently large to allow for the passage of up toseveral sutures110 through thebody102 of thetissue anchor device100 after implantation in the bone tissue as described herein above. As described herein below, eachsuture110 exchanged through anaperture302 may be doubled over and as a result, theaperture302 may be sized to accommodate the unimpeded passage of2 sutures for every desired suture exchange. In one aspect, theaperture302 may be sized to accommodate a single suture exchange, corresponding to the passage of at least twosutures110 simultaneously. In another aspect, theaperture302 may be sized to accommodate two suture exchanges concurrently, corresponding to the passage of at least foursutures110 simultaneously. In an additional aspect, theaperture302 may be sized to accommodate three or more suture exchanges concurrently, corresponding to the passage of at least sixsutures110 simultaneously.
• In addition, theaperture302 and associated suture exchange fitting300 may be provided with sufficient strength to withstand the pulling forces that are applied by the one or more repair sutures110, thereby maintaining the space within theaperture302 essentially unchanged throughout the suture exchange process and fixation of a soft tissue to a bone tissue using thetissue anchor device100. Non-limiting examples of puling forces applied by the one or more repair sutures110 during the exchange process include: tension resulting from pulling one or more repair sutures and/or friction resulting from the sliding of the one or more sutures through theaperture302. In another aspect, additional tension in the suture may result from pulling multiple sutures through multiple tissue layers and/or multipletissue anchor devices100 withmultiple apertures302 during the course of an orthopedic repair procedure as described herein below. In one aspect, the pulling force applied by the one or more repair sutures110 during the exchange and repair process may be less than about 20 lbs. In various other aspects, the pulling force may be less than about 19 lbs., less than about 18 lbs., less than about 17 lbs., less than about 16 lbs., less than about 15 lbs., less than about 14 lbs., less than about 13 lbs., less than about 12 lbs., less than about 11 lbs., less than about 10 lbs., less than about 8 lbs., less than about 4 lbs., or less than about 2 lbs.
• During a suture exchange, the direction of sliding of the one ormore sutures110 may aligned at a variety of angles relative to the initial orientation of thesutures110 and theaperture302. Without being limited to any particular theory, a fixed suture exchange fitting300 that is unable to rotate may develop pinch points, suture cross-over tensions that may impede a suture exchange, and/or tortuosities that may restrict or prevent the completion of a suture exchange. In various aspects, theaperture302 and associated suture exchange fitting300 may be configured to rotate within a predetermined range during a suture exchange due to torsion resulting from pulling one or more repair sutures110 in a direction offset from a plane coincident with theaperture302. Referring again toFIG. 2, the suture exchange fitting300 may include anexchange ring304 defining theaperture302 in one aspect. In this aspect, theexchange ring304 may be configured to rotate and/or deform under torsional loads to maintain a sufficientlylarge aperture302 for the suture exchange process. In another aspect, theexchange ring304 and associatedaperture302 may consist of rounded shapes and edges to reduce the potential of binding, pinching, or otherwise impeding the sliding of one ormore sutures110 through theaperture302 during a suture exchange. In this other aspect, theexchange ring304 may be configured to include only internal angles of greater than about 90°. In one aspect, theexchange ring304 may be provided in an essentially semicircular shape, as illustrated inFIG. 2.
• In an aspect, the predetermined range through which theexchange ring304 may rotate relative to an initial position of theexchange ring304 in the absence of a torsional load may be up to about 360°. In this aspect, a rotation of theexchange ring304 up to about 360° enables the suture exchange fitting300 to accommodate a variety of suture loads and movements associated with a suture exchange and/or fixation of a soft tissue to an underlying bone tissue, without collapse of theaperture302 and associated increase in pulling friction of the one ormore sutures110. Without being limited to any particular theory, it is thought that rotations of theexchange ring304 to angles over 360° relative to the initial position of theexchange ring304 may result in collapse of theaperture302. In various other aspects, the predetermined range through which theexchange ring304 may rotate relative to an initial position of theexchange ring304 in the absence of a torsional load may be up to about 360°, up to about 340°, up to about 320°, up to about 300°, up to about 280°, up to about 260°, up to about 200°, up to about 180°, up to about 150°, up to about 120°, up to about 90°, up to about 45°, up to about 30°, and up to about 10°.
• In various aspects, theexchange ring304 may be constructed from any suitable biocompatible material including, but not limited to: a metal, a plastic, or a suture or other flexible material including a woven fabric or a braided fabric. In various other aspects, theexchange ring304 may also be provided in the form of a bar or clip machined or formed from a metal or plastic material. In these various other aspects, the bar or clip, when taken in combination with other features or structures of thebody102 and/ordistal tip200, may define theaperture302. In an additional aspect, theaperture302 may be machined, molded or formed directly into thebody102 and/ordistal tip200 of thetissue anchor device100.
• In one aspect, theexchange ring304 may be constructed from a flexible material, thereby enabling theexchange ring304 to deform through a predefined angular range during a suture exchange and/or fixation of a soft tissue to a bone tissue using thetissue anchor device100. In another aspect, the suture exchange fitting300 may be provided with a rotational coupling to thebody102 and/ordistal tip200, thereby enabling the rotation of theexchange ring304 without significant deformation under torsional loads. In yet another aspect, theexchange ring304 may be provided with two or more rigid segments coupled together by one or more rotational couplings, thereby permitting a twisting movement of the two or more segments to accommodate torsional loads while maintaining a sufficientlylarge aperture302 during a suture exchange and/or fixation of a soft tissue to a bone tissue using thetissue anchor device100. In various other aspects, any combination of any of the features described herein above including, but not limited to the flexible material, the rotational coupling, and/or the two or more segments, may be incorporated into thesuture exchange fitting300. Detailed descriptions of the structure and function of specificsuture exchange fittings300 in various aspects are provided herein below.
• In various aspects, theaperture302 of the suture exchange fitting300 may be configured to collapse, thereby essentially fixing the one ormore sutures110 in place within thetissue anchor device100 and creating a more secure tissue fixation structure.FIG. 10 andFIG. 11 are side views of a suture exchange fitting300 with theaperture302 in an open (FIG. 10) and collapsed (FIG. 11) configuration in an aspect. Referring toFIG. 10, once the suture exchange and the initial passage of one or more repair sutures110 through the soft tissue is completed, a collapsing force306 may be applied to the one ormore sutures110. This collapsing force306 may be sufficiently high to collapse theaperture302 into a collapsed configuration, as illustrated inFIG. 11. In one aspect, the collapsing force306 applied by the one or more repair sutures110 after the exchange process may be greater than about 20 lbs. In various other aspects, the collapsing force306 may be greater than about 22 lbs., the collapsing force306 may be greater than about 24 lbs., the collapsing force306 may be greater than about 26 lbs., the collapsing force306 may be greater than about 28 lbs., the collapsing force306 may be greater than about 30 lbs., the collapsing force306 may be greater than about 35 lbs., the collapsing force306 may be greater than about 40 lbs., the collapsing force306 may be greater than about 45 lbs., the collapsing force306 may be greater than about 50 lbs., the collapsing force306 may be greater than about 60 lbs., the collapsing force306 may be greater than about 70 lbs., the collapsing force306 may be greater than about 80 lbs., or the collapsing force306 may be greater than about 100 lbs.
• 1. Flexible Suture Exchange Fittings
• In an aspect, at least a portion of the suture exchange fitting300 may be a flexible elongated element constructed from a flexible material including, but not limited to, a suture material. Non-limiting examples of suture materials suitable for inclusion in a suture exchange fitting300 include: non-absorbable suture materials such as polyethylene, polyester, and the like; absorbable suture materials such as a lactide-glycolide copolymer and the like; and any combination thereof. In one aspect, the inclusion of flexible materials in the suture exchange fitting300 may enable the deformation of the suture exchange fitting300 under torsional loads during suture exchange, as well as the collapse of theaperture302 under the collapsing force306 as described herein above.
• FIG. 12 andFIG. 13 are side and top views, respectively, of adistal tip200 with a suture exchange fitting300 that has been deformed by a torsion resulting from the twisting of asuture110 within theaperture302. In this aspect, theexchange ring304 may be constructed of a flexible material, thereby enabling the deformation of theexchange ring304 from aninitial position304′ through atwist angle308. Theexchange ring304 may twist through a predetermined range as described herein above including, but not limited to up to about 360°. In this aspect, the predetermined range may be influenced by any one or more of at least several factors, described herein below.
• In one aspect, the structural integrity of theexchange ring304 may be sufficient to maintain theaperture302 in an open position in the presence of any forces and torques exerted on theexchange ring304 by one ormore sutures110 in association with a suture exchange and/or fixation of a soft tissue to a bone tissue using thetissue anchor device100. In an aspect, theexchange ring304 may resist deforming in response to a suture pulling force with a magnitude up to the collapsing force as described herein above. In another aspect, theexchange ring304 may permit twisting within a predetermined angular range as described herein above in response to a torsion exerted by the one ormore sutures110 as described herein above. The structural integrity of theexchange ring304 may be influenced by any one or more of at least several factors including, but not limited to: the properties of the material used to construct the exchange ring such as tensile strength and torsional stiffness, the dimensions of theexchange ring304, additional support provided by thebody102 and/ordistal tip300, and the reinforcement of at least a portion of theexchange ring304.
• In an aspect, theexchange ring304 may be formed from a single braided suture. In other aspects, at least a portion of theexchange ring304 may be stiffened or shaped using an application of heat to adhere two or more strands of the braided suture and/or through the application of a coating to the braided suture material. In additional aspect, a coating applied to theexchange ring304 may further reduce the friction between theexchange ring304 and one ormore sutures110 sliding through theaperture302 during a suture exchange or tightening of a suture during fixation of a soft tissue to a bone tissue using thetissue anchor device100. In various other aspects, theexchange ring304 may be constructed from other materials including, but not limited to wire, monofilaments, metals, and the like. Non-limiting examples of suitable coating materials include acrolytes, silicones; polyurethanes; polylactic acid; polyglycolic acid and other degradables; and fibrin glue. In other aspects, the coating may be applied to a portion of theexchange ring304 or to theentire exchange ring304 as needed.
• In an aspect, the structural integrity of theexchange ring304 may be influenced by the dimensions of theexchange ring304.FIG. 14 is a side view of a distal tip and suture exchange fitting300 with a relativelysmall aperture302 in one aspect.FIG. 15 is a side view of a distal tip and suture exchange fitting300 with a relativelylarge aperture302 in another aspect. In both aspects, the aperture size may be quantified by one or more dimensions of theaperture302 including, but not limited to, amaximum height310, amaximum width312, and anaperture area314.
• Referring again toFIG. 14 andFIG. 15, themaximum height310 with respect to themaximum width312 of theexchange ring304 may influence the overall performance of the suture exchange. A relatively longer maximum height310 (seeFIG. 15) may increase the rotational flexibility of theexchange ring304; however, excessivemaximum height310 may permit thering exchange ring304 to easily twist more than 360° which may effectively collapse theaperture302, thereby hindering a suture exchange. A relatively shorter maximum height310 (seeFIG. 14) may better resist twisting and collapse and thereby better maintain an open aperture compared to ataller exchange ring304; however, if theexchange ring304 is too short theaperture302 may be too small to accommodate the combined mass of allsutures110 and may thereby hinder a suture exchange.
• In various aspects, the ratio of themaximum width312 to the maximum height of theaperture310 may range from about 1:10 to about 3:1. In various other aspects, the ratio of themaximum width312 to the maximum height of theaperture310 may range from about 1:10 to about 1:8, from about 1:9 to about 1:7, from about 1:8 to about 1:6, from about 1:7 to about 1:5, from about 1:6 to about 1:4, from about 1:5 to about 1:3, from about 1:4 to about 1:2, from about 1:3 to about 1:1, from about 1:2 to about 2:1, and from about 1:1 to about 3:1.
• In an aspect, theaperture area314 may be sufficient to accommodate a single, double, or triple suture material mass, corresponding to a single loaded, double loaded, or triple loadedtissue anchor device100, respectively. In another aspect, theaperture area314 may provide additional space for a first suture to shift position relative to a second suture.FIG. 16 is a side view of a triple-loaded suture exchange fitting300 in which theaperture area314 provides additional space for afirst suture110 to change positions relative to asecond suture110A.
• i) First and Second Spaced-Apart Locations
• In an aspect, the structural integrity of the suture exchange fitting300 may be enhanced by securing at least a portion of the suture exchange fitting300 to thebody102 and/or thedistal tip200 at a first and second spaced-apart location. In this aspect, the secured portions of the suture exchange fitting300 may be maintained in separated positions, thereby maintaining theaperture302 of the suture exchange fitting300 in an open position.FIG. 17 is a side cross-sectional view of atissue anchor device100 in which theexchange ring304 of the suture exchange fitting300 is secured within thepassage116 of the body at a first spaced-apartlocation146 and at a second spaced-apartlocation148. The first and second spaced-apartlocations146/148 are typically positioned on opposite positions within thelumen116 in order to maintain theaperture302 in as wide-open a position as possible within thelumen116.
• Theexchange ring304 of the suture exchange fitting300 may be secured within thelumen116 of thebody102 by any known means without limitation. Referring again toFIG. 17, theinner wall120 of thebody102 may be provided with a pair offixation fittings150/152 through which theexchange ring304 may be threaded, thereby fixing theexchange ring304 at the first and second spaced-apartlocations146/148. Any suitable fixation fitting may be used without limitation. In one aspect, thefixation fittings150/152 may be a mechanical fitting including, but not limited to: a ring (seeFIG. 17), a hook, or a loop. In another aspect (not shown) theexchange ring304 may be affixed to theinner wall120 at the first and second spaced-apartlocations146/148 using a biocompatible adhesive. In yet another aspect (not shown) theexchange ring304 may be affixed by melting theinner wall120 and/or portions of theexchange ring304 at the first and second spaced-apartlocations146/148. In various aspects, thefixation fittings150/152 may be configured to release the secured portions of theexchange ring304 when theexchange ring304 is subjected to a collapsing force306, to enable the collapsing of theaperture302 once a suture exchange through theexchange ring304 is completed.
• In other aspects, at least a portion of theexchange ring304 may be affixed at first and second spaced-apartlocations146/148 situated on thedistal tip200 at a first andsecond side212/214 in order to maintain theaperture302 in an open position. In these other aspects, theexchange ring304 may be affixed to thedistal tip200 and then thedistal tip200 may be inserted into thedistal opening138 of thebody102. Once assembled, theexchange ring304 is situated proximal to thedistal tip200 within thepassage116 of thebody102, as illustrated inFIG. 2.
• Referring toFIG. 18, the first andsecond side212/214 of thedistal tip200 may be provided with a first and asecond channel216/218 configured to hold at least a portion of theexchange ring304 in one aspect. The first andsecond channels216/218 may be aligned with thelongitudinal axis118 of thetissue anchor device100 in an aspect. In another aspect, the first andsecond channels216/218 may extend over at least a portion of thedistal tip300.
• Referring again toFIG. 7, the first andsecond channels216/218 may be grooves extending the entire length of thedistal tip300. In this aspect, theexchange ring304 of the suture exchange fitting300 may be wrapped around thedistal tip200 with portions of the exchange ring situated within the first andsecond channels216/218, as illustrated inFIG. 8; theexchange ring304 may be wrapped around thedistal tip200 before thedistal tip200 is pressed into thebody102. Once theproximal shaft202 is inserted into thedistal opening138 of thebody102, the portions of theexchange ring304 are retained between the first andsecond channels216/218 and theinner wall120 of thedistal opening138. In this aspect, thedistal tip200 maintains theaperture302 of theexchange ring300 in an open position and prevents theaperture302 from collapsing.
• FIG. 19 is a side cross-sectional view of anexchange ring304 constructed from a single piece of a flexible material including, but not limited to a suture, in which the flexible material is affixed at the first and second spaced-apartlocations146/148 in an aspect. As illustrated inFIG. 19, the first and second spaced-apartlocations146/148 may correspond to different sides of thedistal tip200 as described herein previously. In this aspect, the flexible material may include afirst tail316 situated between theflange204 of thedistal tip200 and thedistal face140 of thebody102. The flexible material may further include asecond tail318 situated between theflange204 of thedistal tip200 and thedistal face140 of thebody102 opposite to thefirst tail316. In this aspect, the first and second ends318 may be held in place by compressive forces between thedistal tip200 and thebody102 as described herein previously. In another aspect, theflange204 and/or thedistal face140 may include additional features (not shown) to enhance the fixation of the first and second ends316/318 including, but not limited to: grooves or channels formed in theflange204 and/ordistal face140,
• In another aspect (not illustrated), the first and second spaced-apartlocations146/148 situated on thedistal tip200 may be provided in the form of a first lumen and a second lumen formed through thedistal tip200. The first and second lumens may be aligned with thelongitudinal axis118 of thetissue anchor device100 and may open at theproximal shaft202 and thedistal end208 of thedistal tip200. The first and second lumens may further be situated near the outer perimeter of thedistal tip200 and located at opposite sides of thedistal tip200. In this other aspect, theexchange ring304 may be formed from a single length of a flexible material as described herein previously, with thefirst tail316 threaded through the first lumen and thesecond tail318 threaded through the second lumen. The first tail and the second tail may be glued and/or melted within the first and second lumens. The first and second tails may be threaded through the first and second lumens and the distal ends of the first and second tails knotted to prevent the tails from retracting proximally through the lumens; each tail may be knotted separately, or the first and second tails may be knotted to one another.
• FIG. 20 is a side view of adistal tip200 and suture exchange fitting300 in an aspect. In this aspect, theexchange ring304 may be created by adhering thefirst tail316 and thesecond tail318 of a single length of a flexible material including, but not limited to, a suture segment directly to thedistal tip200 at first and second spaced-apartlocations146/148; the first andsecond tails316/318 may also be directly overmolded into thedistal tip200 at the first and second spaced-apartlocations146/148. In this aspect, thedistal tip200 may be provided with aproximal face220 to provide a surface suitable for adhering the first andsecond tails316/318. In another aspect, theproximal face220 may be provided with one or more fixation features (not shown) at the first and second spaced-apartlocations146/148 to further facilitate the adhesion of the first andsecond tails316/318 to thedistal tip200. Non-limiting examples of suitable fixation features include depressions, grooves, channels, bores, lumens, and raised features such as clips, hooks, and the like.
• ii) Flexible Exchange Rings
• In various aspects, theexchange ring304 may be constructed from any suitable flexible material without limitation. In one aspect, theexchange ring304 may be constructed from standard suture. In another aspect, the suture may be a continuous ring including, but not limited to a suture formed through a continuous braiding process. In this one aspect, thefirst tail316 and thesecond tail318 may extend into one another in a continuous manner to form the continuous loop.
• In another aspect, the suture may be a single piece ending in afirst tail316 and asecond tail318. In this other aspect, thefirst tail316 and asecond tail318 may be secured to thebody102 and/ordistal tip200 at a first spaced apartlocation146 and at a second spaced-apart location, respectively, as described herein previously.
• In yet another aspect, thefirst tail316 and thesecond tail318 of the suture may be tied to one another in a knot to form theexchange ring304. Referring again toFIG. 7 andFIG. 8, theknot320 may be situated near thedistal end208 of thedistal tip200. In an aspect, thedistal end208 may include a feature to retain theknot230 including, but not limited to, adistal recess206. In various aspects, theknot320 may be one of any variety of suitable knots. However, theknot320 may be configured to avoid undesirable stress concentrations in the suture that may result in a premature failure of theexchange ring304, and may be further configured to withstand any anticipated loads on thetissue anchor device100 during prolonged use without slipping or untying.
• In an aspect, theknot320 may be reinforced to prevent slipping or untying using any suitable knot reinforcement method. Non-limiting examples of suitable knot reinforcement methods include: heating and melting the first andsecond tails316/318 of theknot320, applying a stiff material to the first andsecond tails316/318 of theknot320, and any combination thereof. In another aspect, theknot320 may also be set and/or reinforced by heating and melting theouter surface322 of the entire knot in order to stiffen the material without compromising the strength of the suture. In an additional aspect, an adhesive or other coating may be applied to theouter surface322 of theknot320 to stiffen and reinforce theknot320. Non-limiting examples of suitable adhesives or other coatings include: polymers, epoxies, adhesives, plastics, and any combination thereof.
• In an aspect, the stiffness of at least a portion of theexchange ring304 formed from a flexible material may be modified by the addition of one or more reinforcement features. In one aspect, the flexible material may be heated and/or melted in one or more portions to stiffen the one or more portions of theexchange ring304. In another aspect, at least a portion of the flexible material may be coated, impregnated, and/or overmolded with adhesive or other coating material including, but not limited to: polymers, epoxies, adhesives, plastics, and any combination thereof. The stiffness of the supporting material can be controlled to allow the ring to collapse once a defined load has been reached.
• In another aspect, thefirst tail316 and thesecond tail318 may be joined by a joining member (not shown) configured to retain the first andsecond tails316/318, thereby forming the continuous ring. The joining member may be any suitable joining device including, but not limited to: a splice, a clamp, and a joiner. The joining member may be constructed from any suitable material including, but not limited to: metals, polymers, epoxies, adhesives, plastics, and any combination thereof. The joining member may be affixed to the first andsecond tails316/318 by any suitable mechanism including, but not limited to: crimping, molding, twisting, advancing a clamp screw or set screw, repositioning a latch, and any other suitable mechanism. In an aspect, the joining member may be seated within adistal recess206 formed within thedistal tip200 opposite to thedistal end208, as illustrated inFIG. 8.
• In another aspect, the stiffness of at least a portion of theexchange ring304 formed from a flexible material may be stiffened by the incorporation of additional reinforcing elements. The additional reinforcing elements may be incorporated at any portion of theexchange ring304 and may be attached, imbedded or otherwise incorporated as described herein below. In various aspects, the one or more additional reinforcing elements may be configured to fail upon exposure to a load in excess of a collapsing force306 to enable the collapsing of theaperture102 and locking of the one ormore sutures110 within theaperture102 after completion of a suture exchange.
• FIG. 21 is a side view of anexchange ring304 that includes a flexible material and an external reinforcingelement322. In one aspect, the external reinforcingelement322 may be provided in the form of a sleeve situated over the top of theexchange ring304, as illustrated inFIG. 21. In another aspect, the external reinforcingelement322 may be provided in the form of a U-shaped reinforcement structure situated on at least a portion of the inner surface of theexchange ring304 adjacent to theaperture302, as illustrated inFIG. 22. In these aspects, the external reinforcingelement322 may be constructed of any suitably stiff and biocompatible material including, but not limited to: a polymer, a plastic, a metal, a suture sleeve, and any combination thereof. This approach may also create a smooth bearing interface to allow arepair suture110 to more easily slide through theaperture302 during an exchange process. To this end, the external reinforcingelement322 may be constructed of a material characterized by a relatively low friction coefficient.
• FIG. 23 is a side view of anexchange ring304 that includes a flexible material and an internal reinforcingelement324. In one aspect, the internal reinforcingelement324 may be provided in the form of a reinforcinginsert324 situated in asuture lumen326. In one aspect, the top of theexchange ring304. In this aspect, the external reinforcingelement322 may be constructed of any suitably stiff and biocompatible material including, but not limited to: a polymer, a plastic, a metal including NiTi, stainless steel, and/or titanium, and any combination thereof.
• In various aspects, the stiffness of the reinforcingelement322/324 may be modulated through a variety of means to allow theexchange ring304 to collapse once the collapsing force306 has been exceeded after a suture exchange. The dimensions of the reinforcingelement322/324 may be configured to create a region of high stress that may collapse upon exposure to a force in excess of the collapsing force306. By way of non-limiting example, the reinforcingelement322/324 may include a local thin or hollow region configured to fail, thereby enabling the collapse of theexchange ring304. The reinforcingelement322/324 may be provided in the form of a composite element in which one or more regions may be constructed from a weaker material configured to preferentially fail before the remainder of the reinforcingelement322/324, thereby enabling the collapse of theexchange ring304. The reinforcingelement322/324 may further include one or more regions in which a portion of the material has been removed, including, but not limited to defects, cutouts, gaps, and/or perforations.FIG. 24 is a side view of an internal reinforcing element that includes adefect328 configured to preferentially fail and collapse theexchange ring304 at sufficiently high loads.
• 2. Rigid Suture Exchange Fittings
• In various aspects, theexchange ring304 may also be constructed from any suitable rigid and biocompatible material without limitation. Non-limiting examples of suitable rigid materials include: polymers, plastics, metals including NiTi, stainless steels, and/or titanium and titanium alloys, and any combination thereof. In one aspect, theexchange ring304 may be constructed from a wire, a braided cable, a coated wire, a coated braided cable, a molded plastic, and any other suitable rigid structure. In an aspect, the rigid material of theexchange ring304 may provide a smooth bearing interface defining theaperture302 to allow therepair suture110 to more easily slide through theexchange ring304 during the exchange process. Further, therigid exchange ring304 may be well-suited to maintain theaperture302 in the presence of various loads associated with a suture exchange. In an aspect, the stiffness of therigid exchange ring304 may be modulated through a variety of means to allow theexchange ring304 to collapse once the collapsing force306 has been exceeded after a suture exchange. The dimensions of theexchange ring304 may be configured to create a region of high stress that may collapse upon exposure to a force in excess of the collapsing force306. By way of non-limiting example, theexchange ring304 may include a local thin or hollow region configured to fail, thereby enabling the collapse of theexchange ring304. Theexchange ring304 may be provided in the form of a composite element in which one or more regions may be constructed from a weaker material configured to preferentially fail before the remainder of theexchange ring304, thereby enabling its collapse. Theexchange ring304 may further include one or more regions in which a portion of the material has been removed, including, but not limited to defects, cutouts, gaps, and/or perforations.
• In one aspect, therigid exchange ring304 may be relatively limited with respect to the range of rotation of theaperture102 enabled during a suture exchange. In various other aspects, thesuture exchange fixture200 may include additional features to enable the rotation of theexchange ring304 within a predetermined range during a suture exchange as described previously herein. These additional features may enable rotation of a rigidsuture exchange fixture200 within a limited range. Non-limiting examples of additional features include various cylindrical or spherical cavities formed within thepassage116 of the body and/or thedistal tip200 that may interact with one or more features of the suture exchange fitting300 to enable the rotation of theaperture302 during a suture exchange. In another additional aspect, therigid exchange ring304 may include additional features to permit theexchange ring304 to freely swivel without limitation.
• FIG. 50A,FIG. 50B andFIG. 50C are cutaway views of atissue anchor device100 that include a free-swivelingrigid exchange ring304 in one aspect. Referring toFIG. 50A, thetissue anchor device100 in this aspect may include theexchange ring304, positioned within thepassage116 of thetissue anchor device100. Theexchange ring304 may be configured to rotate or swivel freely with respect to thebody102 of thetissue anchor device100. The swiveling functionality in this aspect decouples the rotational orientation of theexchange ring304 from the rotational orientation of thebody102 of thetissue anchor device100, thereby allowing the orientation of one ormore sutures110 threaded through theaperture302 ofexchange ring304 in any desired direction without regard to the rotation of thebody102 of thetissue anchor device100.
• FIG. 50A illustrates a cut-away view of thetissue anchor device100 that includes the free-swivelingexchange ring304 in one aspect. A first rotational orientation of thebody102 is illustrated inFIG. 50A, with abody landmark190 shown as a reference. Theexchange ring304 may be positioned within theaperture302 ofbody102. As shown inFIG. 50A, therigid exchange ring304 may be retained via aflexible link192 that permits essentially unlimited rotation about the screw axis.
• In various aspects, thelink192 may be constructed from any suitable flexible material without limitation including, but not limited to, a thread or suture material. Thelink192 may be provided in any form without limitation including, but not limited to, a strip, a loop, a band, or any other suitable flexible form capable of enabling free rotation of theexchange ring304. As illustrated inFIG. 50A, theflexible link192 may be provided in the form of a suture or thread that is doubled and looped through theaperture302 of theexchange ring304 and passed through thedistal opening138 within thedistal tip200 of thetissue anchor device100 in an aspect. In this aspect, thedistal end196 of thelink192 may terminate in aknot194 or other suitable joining or terminating structure to retain thedistal end196 outside of thedistal tip200, thereby providing a robust and swiveling attachment of theexchange ring304 to thebody102. Theexchange ring304 may be of a different structure or configuration than that shown inFIG. 50A that allows free-swiveling movement relative to thebody102 of thetissue anchor device100 without departing from the spirit of the invention.
• FIG. 50B is an illustration of thetissue anchor device100 shown inFIG. 50A with thebody102 rotated at a 45° angle about the screw axis relative to the orientation shown inFIG. 50A, as evidenced by the change in orientation of thebody landmark190. As shown inFIG. 50B, while thebody102 of thetissue anchor device100 is rotated at a 45° angle, the orientations of theexchange ring304 andaperture302, thelink192, and the one ormore sutures110 are unchanged from the orientations illustrated inFIG. 50A.
• FIG. 50C is an illustration of thetissue anchor device100 shown inFIG. 50A with thebody102 rotated at a 90° angle about the screw axis relative to the orientation shown inFIG. 50A, as evidenced by the change in orientation of thebody landmark190. As shown inFIG. 50C, while thebody102 of thetissue anchor device100 is rotated at a 90° angle, the orientations of theexchange ring304 andaperture302, thelink192, and the one ormore sutures110 are unchanged from the orientations illustrated inFIG. 50A andFIG. 50B.
• The decoupling of the rotational orientation of theexchange ring304 from those elements of thetissue anchor device100 affixed within a bone provides advantages that would be appreciated by those of skill in the art. Theexchange ring304 may rotationally orient in a direction that minimizes the tortuosity of the path traversed by the one ormore sutures110 threaded through theaperture302 of theexchange ring304. In contrast, asuture110 loaded into a fixed thread-holding member (not shown) may become twisted when the suture anchor device (not shown) is deployed and screwed into a bone. Without being limited to any particular theory, reducing the tortuosity of the suture's path may reduce the amount of force required to exchange one ormore sutures110 between one or moretissue anchor devices100 as described herein. Swiveling may further allow asuture110 threaded through anexchange ring304 to slide with minimal tortuosity when tensioning thesuture110 within a particular repair construct as described herein below.
• FIG. 25 is a cross-sectional side view of atissue anchor device100 with a rigid exchange ring provided in the form of a bar orclip330 in an aspect. In this aspect, theclip330 may be contained within acavity222 formed within thedistal tip200. Thelower wall224 of the cavity may be relatively wide, thereby permitting theclip330 to rotate within thecavity222 during a suture exchange. In an aspect, thecavity222 may include an annular groove (not shown) formed in thelower wall224 within which the ends332 of theclip330 may slide to enable rotation of theaperture302 during a suture exchange. In this aspect, the annular groove may extend around the entire circumference of thelower wall224, or the annular groove may extend over a portion of the circumference of thelower wall224 to constrain the rotation of theclip330 to within a limited range. In this aspect, theupper wall224 may taper proximally from the relatively widelower wall224 to anarrow neck230. During a suture exchange, theclip330 may be subjected to relatively low pulling forces from the one ormore sutures110. After completion of the suture exchange, a pulling force in excess of the collapsing force306 may cause theclip330 to deform into acollapsed clip330′ in which the ends332 of theclip330′ are forced together by the narrow diameter of theneck230. In the collapsed configuration, theclip330′ may entrap the one ormore sutures110, thereby preventing any further sliding movements.
• FIG. 26 is a cross-sectional side view of atissue anchor device100 with arigid exchange ring304 provided in the form of aU-shaped clip330 in another aspect. In this other aspect, theU-shaped clip330 may be contained within acavity222 formed within thedistal tip200. Thewall224 of thecavity222 may be relatively wide, thereby permitting theU-shaped clip330 to rotate within thecavity222 during a suture exchange. In an aspect, thecavity222 may include an annular groove (not shown) formed in thewall224 within which the ends332 of the U-shaped clip may slide to enable rotation of theaperture302 during a suture exchange in a manner similar to the annular groove described herein previously in connection with the suture exchange fitting300 ofFIG. 25. In this aspect, the distal tip may further include a relativelynarrow neck230 situated distally to thecavity222. During a suture exchange, the U-shaped clip in the open configuration is subjected to relatively low pulling forces from the one ormore sutures110 and freely rotates within thecavity222. After completion of the suture exchange, the U-shaped clip may be pushed down distally into theneck230, thereby forcing theends332 of theclip330 to deform into acollapsed clip330′. In the collapsed configuration, thecollapsed clip330′ may entrap the one ormore sutures110, thereby preventing any further sliding movements. The ends332 of theclip330′ may includebarbs333 that may retain theends332 within thecavity222; thecollapsed clip330′ may resist unlocking from thecavity222 even when the repair sutures110 are tensioned.
• FIG. 27 is a cross-sectional side view of atissue anchor device100 with anexchange ring304 provided in the form of arigid exchange ring304 in an additional aspect. In this additional aspect, therigid exchange ring304 may freely float within acavity222 formed within thetissue anchor device100. In various aspects, thecavity222 may be formed within thebody102 or within thedistal tip200 of thetissue anchor device100. Therigid exchange ring304 defines anaperture302 that is sufficiently large to allow for a suture exchange. Therigid exchange ring304 may also to rotate with respect to thelongitudinal axis118 of thetissue anchor device100. In another aspect, thecavity222 may be provided with one or more ridges (not illustrated) or other mechanical stops to limit the rotation of therigid exchange ring304 within a limited rotational range inside of thecavity222. In an aspect, the ridges may be aligned parallel with thelongitudinal axis118 of thetissue anchor device100.
• FIG. 28 is a cross-sectional side view of atissue anchor device100 with anexchange ring304 provided in the form of abearing334 in another aspect. In this other aspect, thebearing334 may be situated in acavity222 formed between thebody102 and within thedistal tip200 of thetissue anchor device100. In an aspect, thebearing334 may be provided as an essentially cylindrical bar with acircumferential groove336 or neck in the mid-section of thebearing334. Thebearing334 may be free to rotate about its own axis338 which would ease a suture exchange. Thebearing334 may also be free to rotate around thelongitudinal axis118 of thetissue anchor device100 to allow the one or more repair sutures110 (not shown) to self-align in the direction of suture tension. Thegroove336 provides a guide for the one ormore sutures110 and prevents anysutures110 from becoming pinched between theinner wall120 of thebody102 and thebearing334.FIG. 29 is a perspective view of a disk-shapedbearing334A with agroove336 formed at the mid-section of the bearing334A in another aspect.
• FIG. 30 is a cross-sectional side view of atissue anchor device100 with anexchange ring304 provided in the form of a bearing334B in another aspect. In this other aspect, thebearing334 may be situated in acylindrical cavity222 formed between thebody102 and within thedistal tip200 of thetissue anchor device100. In an aspect, thebearing334B may be provided as aring340 with atransverse bar342 across thering340.FIG. 31 is a top view of the bearing334B in this aspect. Thebearing334B may be free to rotate about its own axis338 which would ease a suture exchange. Thebearing334 may also be free to rotate around thelongitudinal axis118 of thetissue anchor device100 to allow the one or more repair sutures110 (not shown) to self-align in the direction of suture tension. Thegroove336 provides a guide for the one ormore sutures110 and prevents anysutures110 from becoming pinched between theinner wall120 of thebody102 and thebearing334.FIG. 31 is a perspective view of a disk-shapedbearing334A with agroove336 formed at the mid-section of the bearing334A in another aspect.
• FIG. 32 is a cross-sectional side view of atissue anchor device100 with anexchange ring304 attached to ashaft344 provided with one ormore bearings340/342 in another aspect. In this aspect, theexchange ring304 may be attached to aproximal end346 of theshaft344, and afirst bearing340 may be attached to adistal end348 of theshaft344 opposite to theproximal end346. Asecond bearing342 may also be attached to a middle portion of theshaft344 between theexchange ring304 and thefirst bearing340. Theexchange ring304 may be situated within thepassage116, rendering theaperture302 accessible to the one ormore sutures110 via theproximal opening108 of thebody102. Thefirst bearing340 may be retained within asecond cavity232 formed within thedistal end200, and thesecond bearing342 may be retained within acavity222 formed between thedistal end106 of thebody102 and theproximal shaft202. Thefirst bearing340 and thesecond bearing342 may freely rotate about thelongitudinal axis118 of thetissue anchor device100. Thebody102 may have anarrow neck230 defined at a distal end of theaperture116 to entrain theshaft344 between theexchange ring304 and thesecond bearing342. One ormore sutures110 may be looped through theaperture302 in this aspect.
• FIG. 33 is a perspective view of adistal tip200 in which agroove234 is formed in theproximal shaft202 in an aspect. Abar350 may be inserted across transverse to thegroove234 to form asuture exchange fitting300. One ormore sutures110 may be inserted through anaperture302 formed between thebar350 and the base236 of thegroove234. The bone anchor can be constructed such that it has a transverse break in the proximal section of the body of the bone anchor to create a space for the suture exchange. The entire tip assembly may be attached to the body102 (not shown) via thedistal opening138. Thedistal tip200 may be configured to freely rotate about thelongitudinal axis118 of thetissue anchor device100.FIG. 34 is a perspective view of abody102 within which agroove154 is formed within theproximal end104 of thebody102 in an aspect. In this aspect, abar350 may be inserted transversely across thegroove154. One ormore sutures110 may be looped through theaperture302 formed between thebar350 and thebase156 of thegroove154.
• In both of the aspects illustrated inFIG. 33 andFIG. 34, thebar350 may be provided in a variety of cross-sectional shapes and lengthwise profiles without limitation. In an aspect, the bar may be configured to provide a low-friction suture exchange fitting300 capable of accommodating a range of suture pulling forces and changes in the directions of suture pulling forces associated with a suture exchange and the fixation of a soft tissue to a bone tissue using thetissue anchor device100. Non-limiting examples of suitable cross-sectional shapes for thebar350 include circular, elliptical, crescent-shaped and the like. Non-limiting examples of suitable lengthwise profiles for thebar350 include: linear, as illustrated inFIG. 33 andFIG. 34; and curved including an arched, parabolar, and/or semi-circular lengthwise profile. In another aspect, the bar may164 be provided with additional features including, but not limited to: local thinning of thebar350 cross-sectional dimension and/or notches, perforations and/or or other defects formed within at least a portion of thebar350, and any combination thereof to enable the collapse of thebar350 into a collapsed configuration when the bar is subjected to a pulling force in excess of a collapsing force as described herein previously.
• FIG. 35 is a cross-sectional side view of atissue anchor device100 with the suture exchange fitting300 provided in the form of anexchange ring304 attached to aball352 that is pulled into asocket156 formed at thedistal opening138 of thebone anchor body102 or at thedistal end138 of thedistal tip200. Theexchange ring304 may consist of a prefabricated ring produced from a material including, but not limited to, a metal, a polymer, a plastic, a suture, and the like. Theexchange ring304 may be attached to theball352 using any method including, but not limited to: overmolding theball352 onto a portion of theexchange ring304 and/or bonding theexchange ring304 onto theball352 with a biocompatible adhesive. The ball325 may be pulled from outside thedistal end208 ordistal opening138 into thesocket156 by pulling in a proximal direction on theexchange ring304 either directly or via one ormore sutures110 looped through theaperture302 within theexchange ring304. In an aspect, theball352 andsocket156 may be matched in profile to enable the free rotation of the aperture about thelongitudinal axis118 of thetissue anchor device100.
• d. Sutures
• Referring again toFIG. 2, thetissue anchor device100 may further include one ormore sutures110 looped through the suture exchange fitting300 within thebody102 of thetissue anchor device100. Eachsuture110 may include a single loop situated at one end of thesuture110, or two loops situated at opposite ends of thesuture110. In one aspect, asuture110 with a single loop may enable a suture exchange in a single direction (away from the single loop) whereas a suture with a pair of loops may enable suture exchanges in two directions, thereby enhancing the range of functions potentially performed by thesuture110 within thetissue anchor device100. The one ormore sutures110 may be exchanged between different tissue anchor devices100 (not shown) and may be used to anchor a soft tissue to an underlying bone tissue as described in further detail herein below.FIG. 36 is an illustration of asuture110 in one aspect. In this aspect, eachsuture110 may include amain suture length158 ending at afirst suture loop164 attached at afirst suture end160 and asecond suture loop166 attached at asecond suture end162 opposite to thefirst suture end160.
• In various aspects, thesuture loops164/166 may act as snares to reversibly hold and guide the end of asecond suture172 as thesecond suture172 is pulled through tissue and/or anaperture302 of atissue anchor device100.FIG. 37 is a schematic view of an initial step in a suture exchange from a secondtissue anchor device100′ to a firsttissue anchor devices100 in one aspect. In this aspect, afirst suture end160′ and afirst suture loop164′ of asecond suture172 are threaded through thefirst suture loop164 of thefirst suture170; this threading results in thesecond suture172 being doubled over thefirst loop164 of thefirst suture170. Thesecond suture end162 of thefirst suture170 may then be pulled away from the firsttissue anchor device100 to pull thesecond suture172 through the firsttissue anchor device100.FIG. 38 is a schematic illustration of a subsequent stage of the suture exchange shown inFIG. 37. As illustrated inFIG. 38, thefirst loop164 and doubled oversecond suture172 have been pulled through the aperture302 (not shown) of the firsttissue anchor device100, resulting in thesecond suture172 being threaded through both the firsttissue anchor device100 and the secondtissue anchor device100′. Thesecond suture172 may now be pulled at both thefirst suture end160′ and thesecond suture end162′ to compress thesoft tissue402 against theunderlying bone tissue404.
• In various aspects, thesutures110 may be constructed of any suitable suture material without limitation. In an aspect, the sutures may be constructed of a material including, but not limited to: a monofilament, a tubular suture material, a braided suture material, and any combination thereof. Non-limiting examples of suture materials suitable for inclusion in a suture exchange fitting300 include: non-absorbable suture materials such as polyethylene, polyester, Nylon, Cortex, Silk, polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropylene, Poly (ethylene, terephthalate), stainless steel and the like; absorbable suture materials such as a lactide-glycolide copolymer, polyglactin, monocryl, polyester poly(p-dioxanone), and panacryl and the like; and any combination thereof. In one aspect, the inclusion of flexible materials in the suture exchange fitting300 may enable the deformation of the suture exchange fitting300 under torsional loads during suture exchange, as well as the collapse of theaperture302 under the collapsing force306 as described herein above.
• In various aspects, the size of thesutures110 may be any size for use in an orthopedic surgical procedure consistent with the use of thetissue anchor device100 without limitation. In one aspect, the suture diameter may range from about 0.02 mm (USP #10-0) to about 0.8 mm (USP #4). In other aspects, the suture diameters may range from about 0.02 mm to about 0.06 mm, from about 0.04 mm to about 0.08 mm, from about 0.06 mm to about 0.10 mm, from about 0.08 mm to about 0.12 mm, from about 0.10 mm to about 0.14 mm, from about 0.12 mm to about 0.16 mm, from about 0.14 mm to about 0.18 mm, from about 0.16 mm to about 0.20 mm, from about 0.18 mm to about 0.22 mm, from about 0.20 mm to about 0.30 mm, from about 0.25 mm to about 0.35 mm, from about 0.30 mm to about 0.40 mm, from about 0.35 mm to about 0.45 mm, from about 0.40 mm to about 0.50 mm, from about 0.45 mm to about 0.55 mm, from about 0.50 mm to about 0.60 mm, from about 0.55 mm to about 0.65 mm, from about 0.60 mm to about 0.70 mm, from about 0.65 mm to about 0.75 mm, from about 0.70 mm to about 0.80 mm, Non-limiting examples of suitable suture diameters include: USP #10-0 (0.02 mm), USP #9-0 (0.03 mm), USP #8-0 (0.04 mm), USP #7-0 (0.05 mm), USP #6-0 (0.07 mm), USP #5-0 (0.10 mm), USP #4-0 (0.15 mm), USP #3-0 (0.20 mm), USP #2-0 (0.30 mm), USP #0 (0.35 mm), USP #1 (0.40 mm), USP #2 (0.50 mm), USP #3 (0.60 mm), USP #5 (0.70 mm), and USP #6 (0.8 mm).
• In various other aspects, thesutures110 may have an overall length ranging from about 2.5 cm to about 70 cm. In additional aspects, thesutures110 may have an overall length ranging from about 2.5 cm to about 10 cm, from about 5 cm to about 15 cm, from about 10 cm to about 20 cm, from about 15 cm to about 25 cm, from about 20 cm to about 30 cm, from about 25 cm to about 35 cm, from about 30 cm to about 40 cm, from about 35 cm to about 45 cm, from about 40 cm to about 60 cm, and from about 50 cm to about 70 cm.
• Referring again toFIG. 36, the one ormore sutures110 may havesuture loops164/166 at opposite ends160/162 of thesuture110. In an aspect, thedual suture loops164/166 enable thesuture110 to be pulled toward the first suture end and/or thesecond suture end162 as needed in the course of a surgical procedure. Thedouble suture loops164/166 enable suture pull-through in any direction, change of direction, multiple-anchor utilization, after insertion of thetissue anchor device100, during post-insertion linkage changes, and during a remedial surgical procedure including, but not limited to reverse a repair and/or changing a method of linkage.
• In an aspect, the first and second loops sutureloops164/166 may be configured to pull asecond suture172 through a soft tissue and/or anaperture302 within atissue anchor device100. As a consequence, the strength of the first andsecond suture loops164/166 may be less than the tensile strength of themain suture length158, which may be subjected to relatively higher tensions in order to affix a soft tissue to an underlying bone tissue. In another aspect, the first and second loops sutureloops164/166 may be configured to reduce the suture tension associated with pulling thesecond suture172 and optionally one or more additional attachedsutures110′ through the soft tissue and/oraperture302. In this other aspect, the first and second loops sutureloops164/166 may be constructed with a low profile configuration including one or more of at least several features including, but not limited to: relatively low suture diameter, compact collapsed size, smooth transition between thesuture end160/162 and the correspondingsuture loop164/166.
• In one aspect, the first and second loops sutureloops164/166 may be constructed of the same suture material as themain suture length158. In this aspect, theloops164/166 may be formed by forming a loop at the first and second suture ends160/162 and attaching each suture tip to itsrespective suture end160/162. The tips may be attached by any suitable means including, but not limited to: continuous braiding of the loop, biocompatible adhesive, melting/welding, and any combination thereof. In another aspect, the first and second loops sutureloops164/166 may be constructed of a different or smaller-diameter material relative to themain suture length158. In this other aspect, the material used to construct the first and second loops sutureloops164/166 may reduce the overall size of the loops in a collapsed configuration, thereby reducing pulling force during a suture change.
• FIG. 39 is top view of afirst suture loop164 formed by abifurcation168 of themain suture length158 at thefirst suture end164 in one aspect. In this aspect, the distal portion of theloop164 may rejoin to form a full-diameter loop tip174. In this aspect, theloop164 may be securely attached to thesuture end160 by virtue of the continuity of suture material between themain suture length158 and theloop164. In addition, the transition from thesuture end160 to theloop164 is smooth, thereby reducing the pulling friction associated with passing the loop through a soft tissue and/oraperture304. As theloop160 is pulled through a soft tissue or aperture, theloop160 may collapse to a compact size approaching that of the main suture length in this aspect.
• In various aspects, the diameter of eachloop164/166 may be configured to accommodate the suture exchange of one ormore sutures110 in one aspect. In this aspect, the loop diameter may be at least 1 mm. In other aspects, smaller or larger sutures may be used and the loop size diameter may decrease or increase accordingly. In additional aspects, the loop diameter may be at least 1 mm, at least 2 mm, at least 3 mm, at least 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm, at least 9 mm, at least 10 mm, or at least 20 mm. In other aspects, the diameter of eachloop164/166 may be configured to provide a suitable grip for a surgeon's hand or a surgical tool manipulated by a surgeon, or the loop diameter may be configured to simplify the act of loading suture ends160/162 into theloop164/166. In these other aspects, the diameter of each loop may be larger than the diameter that accommodates the suture exchange of one ormore sutures110.
• In an additional aspect, at least a portion of thesuture loops164/166 and/or themain suture length158 in close proximity to thesuture loops164/166 may be stiffened to facilitate the loading ofadditional sutures110 into thesuture loops164/166, to facilitate the loading of thesuture110 by threading thesuture loops164/166 through anaperture302 within atissue anchor device100, to provide tactile feedback to the surgeon, and any combination thereof. In one aspect, theloops164/166 may be stiffened to maintain theloops164/166 in a collapsed configuration, resulting in a smaller profile during use. In another aspect, theloops164/166 may be stiffened to maintain theloops164/166 in an opened configuration, thereby facilitating the loading ofadditional sutures110 into theloops164/166 and/or to provide a larger profile for a surgeon to grip during use. In various aspects, theloops164/166 may be stiffened using any suitable method including, but not limited to heat setting, application of stiffening coatings including, but not limited to a polymer or resin coating, and any combination thereof. However, it is to be noted that the stiffeningloops164/166 may retain the ability to collapse during passage through anaperture304 or tissue without unduly high suture pulling forces that may disrupt the smooth pull of thesutures110 during a surgical procedure associated with good tactile feedback to the surgeon.
II. Surgical Kit
• In an aspect, thetissue anchor device100 described herein above may be included in a surgical kit for use by a surgeon in a surgical procedure.FIG. 40 is a block diagram summarizing the components of thesurgical kit500 in one aspect. Thesurgical kit500 may include thetissue anchor device100 described herein above, including at least onesuture110. The surgical kit may further provideinstructions502 and adelivery device504.
• In various aspects, theinstructions502 may be provided by any suitable means including, but not limited to: printed on packaging enclosing at least some of thesurgical kit500; enclosed within packaging enclosing at least some of thesurgical kit500; accompanying thesurgical kit500; published as an electronic communication such as an e-mail; published on an internet website; and any combination thereof. In various aspects, theinstructions502 may include information associated with the assembly of thetissue anchor device100, information associated with implantation of thetissue anchor device100, information associated with using thetissue anchor device100 in an orthopedic surgical procedure, and any other information relevant to the assembly and use of thetissue anchor device100. In this aspect, information associated with the assembly of thetissue anchor device100 may include guidance for threading the at least onesuture110 through theaperture302 of the suture exchange fitting300, passing the first and second suture ends160/162 proximally through thepassage116 of thebody102 and out theproximal opening108, joining thedistal tip200 to thebody102 by inserting theproximal shaft202 of the distal tip into thedistal opening138 of thebody102, and any combination thereof. In this aspect, information associated with the implantation of thetissue anchor device100 in an orthopedic surgical procedure may include guidance for coupling thedelivery tool504 to thetissue anchor device100 and delivering a torque to drive thetissue anchor device100 into the bone tissue. In this aspect, information associated with using thetissue anchor device100 in an orthopedic surgical procedure may include guidance for exchanging one ormore sutures110 between one ormore apertures302 associated with differenttissue anchor devices100 to enable various surgical procedures including, but not limited to assembling and securing one or more suture patterns suitable for attaching a soft tissue to a bone tissue.
• Thedelivery device504 may be any driver system suitable for orthopedic fasteners without limitation. Non-limiting examples ofsuitable delivery devices504 include: single-slot driver systems, star-shaped driver systems, cruciform driver systems, Phillips driver systems, hexagonal driver systems and any other suitable driver system.
III. Method of Anchoring Soft Tissue
• In various aspects, one or moretissue anchor devices100 may be used to anchor a soft tissue to a bone. The one or moretissue anchor devices100 may be implanted in a bone and linked to one another after implantation via one or more sutures without the use of a knot or other inter-anchor fixation, thereby establishing a contiguous inter-anchor suture ending at a pair of free suture ends. Each suture end is attached to afirst anchor device100 and alast anchor device100′. The free suture ends may be used for any generally accepted final repair fixation practice, including, but not limited to, anchor fixation, knotless anchor fixation, knot fixation, or linkage toadditional anchor devices100″.
• In one aspect, an orthopedic repair including fixation of a soft tissue to a bone may use at least twotissue anchor devices100 and at least onesuture110. Thesuture110 may be passed through the at least two at least twotissue anchor devices100 using a suture exchange method described in detail herein below. Using one or more suture exchanges, asingle suture110 may form a single continuous span or linkage of suture between the at least twotissue anchor devices100. The single continuous suture span may end in two free ends that may be used to implement a final fixation or knot in accordance with standard surgical suture fixation practices and products.
• In this aspect, the use of a single suture provides at least several benefits over existing knotted linkage techniques. The use of a single suture and at least twotissue anchor devices100 as a linkage enables superior adhesion of the soft tissue to the bone compared to a knotted linkage. The use of the at least twotissue anchor devices100 provides the capability to use a “running stich” ofsuture110 for a faster and simplified repair. Because thesuture110 is not fixed at eachanchor100, thesuture110 is capable of sliding to a limited degree between anchor points, thereby efficiently distributing the compression load over the soft tissue. Using this method, the suture tension and stress may also be distributed acrossmultiple anchors100, thereby reducing the likelihood of developing single failure points in which all tension and stress may be isolated to a single anchor. The use of this method further enables the implementation of at least several suture patterns as needed, thereby enhancing the options available to the surgeon and the resulting effectiveness of the surgical procedure.
• FIG. 41 is a flow chart summarizing a method of anchoring a soft tissue to a bone using thetissue anchor device100 described herein above in one aspect. The method may include assembling thetissue anchor device100 atstep602. In one aspect, thetissue anchor device100 may be assembled by causing thedistal tip200 that is loaded with afirst suture110A to be received in thedistal opening138 of thebody102 such that thefirst suture170 extends through thepassage116 of thebody102 and out theproximal opening108 such that the first and second ends160/162 of thefirst suture170 extend proximally from theproximal opening108.
• Referring again toFIG. 41, the method may further include attaching adelivery device504 to thetissue anchor device100 atstep604. In one aspect, thefirst suture170 may be extended through a lumen of thedelivery device504 such that the first and second ends160/162 of thefirst suture170 extend proximally from a proximal end of thedelivery device504 and a distal end of thedelivery device504 is coupled with aproximal end104 of thebody102, the lumen extending between a distal end of thedelivery device504 and the proximal end of thedelivery device504. The coupleddelivery device504 may be used to torque the first tissue anchor into the bone atstep606. In one aspect, thedelivery device504 may apply a torque to thebody102 via the distal end of thedelivery device504 coupled to the tool fitting134 formed within theproximal opening108 as described herein above.
• Referring again toFIG. 41, thetissue anchor device100 may be implanted into the bone atstep608. In one aspect, a bore may be preformed within the bone prior to implanting thetissue anchor device100. In another aspect, if theexternal thread114 of thebody102 includes a self-tapping feature, thetissue anchor device100 may be inserted without need to form a bore beforehand. In one aspect, thetissue anchor device100 may be implanted by advancing thebody102 anddistal tip200 into the bone until theproximal end104 of thebody102 is essentially level with the exposed surface of the bone. In another aspect, if the suture exchange fitting300 is situated proximally to theproximal end104 of thebody102, the body and thedistal tip200 may be advanced into the bone until theproximal end104 of thebody102 is distal relative to the exposed surface of the bone.
• Themethod600 may further include extending the first and second ends160/162 of thefirst suture170 through the soft tissue atstep610. The soft tissue may be any soft tissue to be reattached to a bone including, but not limited to, a tendon and/or a ligament. In an aspect, the first and second ends160/162 of thefirst suture170 may be extended through one or more layers, each layer including a soft tissue to be attached to the bone. Asecond suture172 may be extended through afirst loop164 defined at thefirst end160 of thefirst suture170.FIG. 37 is an illustrating showing thesecond suture172 extended through thefirst loop164 of thefirst suture170. As illustrated inFIG. 37, thefirst end160′ of thesecond suture172 may now extend proximally from a secondtissue anchor device100′ and thesecond end162′ of thesecond suture172 may extend proximally through asoft tissue402.
• In various aspects, variations of themethod600 may be used to implement a variety of suture patterns and techniques as needed to enhance the linkage between thesoft tissue402 and thebone404. Non-limiting examples of suture patterns and techniques include: a single suture box stitch pattern, a lateral medial bridge stitch pattern using a knotless single suture, a medial bridge, inter-implant mattress stitch pattern, a train track, a parallel horizontal repair using 2 anchors, and a medial dam suture pattern to block synovial fluid infiltration. Additional description of the suture patterns and techniques are provided herein below.
• FIG. 42A,FIG. 42B,FIG. 42C,FIG. 42D,FIG. 42E, andFIG. 42F illustrate schematically a single row repair accomplished using an implantedfirst anchor100 with afirst suture170 and an implantedsecond anchor100′ with asecond suture172. The first andsecond anchors170/172 may be implanted as illustrated inFIG. 42A. Referring toFIG. 42B, a suture exchange may be started by threading the second end B2 of thesecond suture172 through the second end A2 of thefirst suture170. As illustrated inFIG. 42C, the exchange of thesecond suture172 into thefirst anchor100 is completed by pulling on the first end A1 of thefirst suture170. Thefirst suture170 may then be removed from thesecond suture172, as illustrated inFIG. 42D. The ends B1/B2 of thesecond suture172 may then be tensioned as illustrated inFIG. 42E. The ends B1/B2 of thesecond suture172 may then be joined using a knot or aknotless joiner176 as illustrated inFIG. 42E.
• FIG. 43A,FIG. 43B,FIG. 43C,FIG. 43D,FIG. 43E,FIG. 43F, andFIG. 43G illustrate schematically a wide single row repair accomplished using an implantedfirst anchor100 with afirst suture170 and an implantedsecond anchor100′ with asecond suture172. The first andsecond anchors170/172 may be implanted as illustrated inFIG. 43A. Referring toFIG. 43B, the suture ends A1/A2 and B1/B2 may be pulled through the soft tissue layer at widely separated locations. Referring toFIG. 43C, a suture exchange may be started by threading the second end B2 of thesecond suture172 through the first end A1 of thefirst suture170. As illustrated inFIG. 43D, the exchange of thesecond suture172 into thefirst anchor100 is completed by pulling on the first end A2 of thefirst suture170. The second suture may be pulled through both widely separated locations in the soft tissue near thefirst anchor170 as illustrated inFIG. 43D. Thefirst suture170 may then be removed from thesecond suture172 to complete the suture exchange, as illustrated inFIG. 43E. The ends B1/B2 of thesecond suture172 may then be tensioned as illustrated inFIG. 43F. The ends B1/B2 of thesecond suture172 may then be joined using a knot or aknotless joiner176 as illustrated inFIG. 43G.
• FIG. 44A,FIG. 44B,FIG. 44C,FIG. 44D,FIG. 44E,FIG. 44F, andFIG. 44G illustrate schematically a double row repair accomplished using implanted single-loadedanchors100A,100B,100C, and100D. Theanchors100A,100B,100C, and100D may be implanted in a square pattern as illustrated inFIG. 44A and both ends of each suture may be pulled through the soft tissue over each corresponding anchor. Referring toFIG. 44B, a suture exchange may be started by threading the first end A1 through the first end C1 and pulling on the second end C2. As illustrated inFIG. 44C, the exchange of suture end A1 through anchor110C may be completed by pulling on the suture end C2. Similar suture exchanges may be further accomplished to pull suture end A2 throughanchor100B as illustrated inFIG. 4D and suture end A1 throughanchor100D, as illustrated inFIG. 44E. Thefirst suture170 may then be removed from thesecond suture172 to complete the suture exchange, as illustrated inFIG. 44E. The ends A1/A2 may then be tensioned as illustrated inFIG. 44F. The ends A1/A2 may then be joined using a knot or aknotless joiner176 as illustrated inFIG. 44G.
• FIG. 45A,FIG. 45B,FIG. 45C,FIG. 45D,FIG. 45E,FIG. 45F, andFIG. 45G illustrate schematically a double row repair accomplished using implanted double-loadedanchors100A,100B,100C, and100D. Theanchors100A,100B may be implanted as illustrated inFIG. 45A and both ends of each suture may be pulled through the soft tissue over each corresponding anchor. Referring toFIG. 45B, a suture exchange may be accomplished by threading the suture end B3 through the suture end A3 and pulling on the opposite suture end A4. Referring toFIG. 45C, a suture exchange may be accomplished by threading the suture end B1 through the suture end A2 and pulling on the opposite suture end A1. As illustrated inFIG. 45D, the additional double-loadedanchors100C and100D may be implanted, resulting in a square anchor pattern. Referring toFIG. 45E, the exchange of suture ends B1 and B2 through anchor110C may be completed similarly using the two loaded sutures ofanchor100C. Referring toFIG. 45F, the exchange of suture ends B3 and B4 through anchor110D may be completed similarly using the two loaded sutures ofanchor100D. The ends A1, A2, B1, and B2 may then be tensioned and joined using a knot or aknotless joiner176 as illustrated inFIG. 45G.
• FIG. 46A,FIG. 46B,FIG. 46C,FIG. 46D,FIG. 46E,FIG. 46F, andFIG. 46G illustrate schematically a transosseous repair accomplished using implanted double-loadedanchors100A,100B,100C, and100D. Theanchors100A,100B may be implanted as illustrated inFIG. 46A and both ends of each suture may be pulled through the soft tissue situated over each corresponding anchor. Referring toFIG. 46B, a suture exchange may be accomplished by threading the suture end B3 through the suture end A3 and pulling on the opposite suture end A4. Referring toFIG. 46C, a suture exchange may be accomplished by threading the suture end B1 through the suture end A2 and pulling on the opposite suture end A1. As illustrated inFIG. 46D, the additional double-loadedanchors100C and100D may be implanted in a different bone or at an offset location not covered by the soft tissue layer, resulting in a square anchor pattern. Referring toFIG. 46E, the exchange of suture ends B1 and B2 through anchor110C may be completed similarly using the two loaded sutures ofanchor100C, and the exchange of suture ends B3 and B4 through anchor110D may be completed similarly using the two loaded sutures ofanchor100D. Referring toFIG. 46F, the suture ends A1, A2, B1, and B2 may be tensioned and retained knotlessly within correspondinganchors100C and100D. Alternatively, the ends A1, A2, B1, and B2 may then be tensioned and joined using a knot or aknotless joiner176 as illustrated inFIG. 46G.
• FIG. 47A andFIG. 47B are schematic illustrations of additional arrangements of sutures and anchors associated with double row repairs illustrated inFIG. 44G andFIG. 45G, respectively.FIG. 47A illustrates a double-row repair accomplished using implanted single-loadedanchors100A,100B,100C and100D. As illustrated in FIG,47A, the ends of the singlecontinuous suture170 may be crossed over and secured within a pair of implanted knotless anchors110E and100F.FIG. 47B illustrates a double-row repair accomplished using implanted double-loadedanchors100A,100B,100C and100D. As illustrated in FIG,47B, the ends of a first singlecontinuous suture170 may be crossed over and secured within a pair of implanted knotless anchors110E and100F, and the ends of a second singlecontinuous suture172 may be secured within the pair of implanted knotless anchors110E and100F without crossing over.
• FIG. 48A,FIG. 48B,FIG. 48C, andFIG. 48D illustrate schematically a traditional bridged repair accomplished using implanted double-loadedanchors100A,100B,100C, and100D. Theanchors100A,100B may be implanted as illustrated inFIG. 48A and both ends of each suture may be pulled through the soft tissue over each corresponding anchor. Referring toFIG. 48B, a suture exchange may be accomplished by threading the suture end B1 through the suture end A3 and pulling on the opposite suture end A4. Referring toFIG. 48C, suture ends B1 and B2 may be tensioned and joined with a knot. As illustrated inFIG. 48D, the additional double-loadedanchors100C and100D may be implanted, resulting in a square anchor pattern. Referring again toFIG. 48D, the exchange of suture ends A1 and B3 through anchor110C and the exchange of suture ends A2 and B4 through anchor110D may be completed similarly using the pairs of sutures loaded onanchors100C and100D. Referring toFIG. 48E, the ends A1, A2, B3, and B4 may be tensioned and secured using asingle knotless anchor100E. Referring toFIG. 48F, the suture ends A1 and B3 may be secured usingknotless anchor100C, and suture ends A2 and B4 may be tensioned and secured usingknotless anchor100D.
• FIG. 49A,FIG. 49B,FIG. 49C,FIG. 49D,FIG. 49E,FIG. 49F,FIG. 49G,FIG. 49H,FIG. 49I, andFIG. 49J illustrate schematically repair of a labrum tear accomplished using implanted double-loadedanchors100A,100B,100C, and100D. Theanchors100A,100B,100C, and100D may be implanted within aglenoid bone180 as illustrated inFIG. 49A, and the opposite ends of each suture may be situated at opposite sides of theoverlying labrum tissue178. Referring toFIG. 49B and 49G, a suture exchange of suture end A2 betweenanchor100A andanchor100B may be accomplished using one of the two sutures threaded throughanchor100B. Referring toFIG. 49C andFIG. 49H, the suture end A2 may be threaded successively throughanchors100B,100C, and100D in a spiral pattern using one of the loaded sutures in each corresponding anchor. As illustrated inFIG. 49H, the suture end A2 passes over thelabrum180 between successive anchors and passes under thelabrum180 as the suture end A2 passes through each successive anchor. As illustrated inFIG. 49D andFIG. 49I, the suture end A2 may be exchanged fromanchor100D to anchor100C using the remaining loaded suture inanchor100C. Referring toFIG. 49E andFIG. 49J, the suture end A2 may be threaded successively throughanchors100B,100C, and100D in a spiral pattern using the remaining loaded suture in each corresponding anchor. As illustrated inFIG. 49J, the suture end A2 passes over thelabrum180 between successive anchors and passes under thelabrum180 as the suture end A2 passes through each successive anchor; the direction of crossing is opposite to the direction illustrated inFIG. 49H, resulting in a crossed suture pattern around thelabrum180. Referring toFIG. 49F, the suture ends A1 and A2 may be tensioned and secured with a knot or knotless joiner.
• The foregoing merely illustrates the principles of the invention. Various modifications and alterations to the described embodiments will be apparent to those skilled in the art in view of the teachings herein. It will thus be appreciated that those skilled in the art will be able to devise numerous systems, arrangements and methods which, although not explicitly shown or described herein, embody the principles of the invention and are thus within the spirit and scope of the present invention. From the above description and drawings, it will be understood by those of ordinary skill in the art that the particular embodiments shown and described are for purposes of illustrations only and are not intended to limit the scope of the present invention. References to details of particular embodiments are not intended to limit the scope of the invention.

Claims (44)

What is claimed is:

1. A tissue anchor comprising:

a body comprising a proximal end, a distal end opposite the proximal end, a proximal opening at the proximal end, a distal opening at the distal end, and a passage extending longitudinally through the body between the proximal and distal openings; and

a flexible elongated element at least contributing to the defining of an aperture that opens in a direction substantially perpendicular to a longitudinal axis of the passage, the flexible elongated element being secured to the body at first and second spaced-apart locations facilitating the aperture being maintained in an open condition.

2. The tissue anchor ofclaim 1, wherein the first and second spaced-apart locations includes a first side of the passage and a second side of the passage opposite the first side of the passage.

3. The tissue anchor ofclaim 2, wherein the flexible elongated element is secured to the each side of the passage via a ring, hook or loop.

4. The tissue anchor ofclaim 2, wherein the body further comprises a distal tip that is at least one of received or configured to be received in the distal opening, and the first and second spaced-apart locations include a first side of the distal tip and a second side of the distal tip opposite the first side of the distal tip.

5. The tissue anchor ofclaim 1, wherein the body further comprises a distal tip that is at least one of received or configured to be received in the distal opening, the flexible elongated element comprising a first tail and a second tail spaced-apart from the first tail by the first tail and the second tail respectively intersecting the distal tip at the first and second spaced-apart locations thereby facilitating the aperture being maintained in the open condition.

6. The tissue anchor ofclaim 5, wherein, when the distal tip is received in the distal opening, the aperture is located in the passage proximal the distal tip.

7. The tissue anchor ofclaim 5, wherein the distal tip comprises a molded material and a distal region of the first tail and a distal region of the second tail are molded into the molded material at the first and second spaced-apart locations.

8. The tissue anchor ofclaim 5, wherein the distal tip is configured such that implantation forces exerted on the distal tip enhance the extent to which the distal tip is received in the distal opening.

9. The tissue anchor ofclaim 5, wherein the first and second spaced-apart locations respectively comprise first and second spaced-apart channels in the distal tip, and a distal region of the first tail and a distal region of the second tail are respectively located in the first and second spaced-apart channels.

10. The tissue anchor ofclaim 9, wherein the first spaced-apart channel comprises a groove defined in an outer surface of the distal tip and the distal region of the first tail extends through the groove, which opens against an inner wall surface defining the passage when the distal tip is received in the distal opening.

11. The tissue anchor ofclaim 9, wherein the first spaced-apart channel comprises a lumen defined in the distal tip and the distal region of the first tail extends through the lumen.

12. The tissue anchor ofclaim 9, wherein the first and second tails are distally joined together via a knot.

13. The tissue anchor ofclaim 11, wherein the knot is coated or impregnated with a polymer, epoxy or adhesive.

14. The tissue anchor ofclaim 9, wherein the first and second tails are part of a continuous loop of the flexible elongated element, the first and second tails extending into each other in a continuous manner.

15. The tissue anchor ofclaim 9, wherein the first and second tails are distally joined together via a joining member extending about the at least portions of the first and second tails.

16. The tissue anchor ofclaim 15, wherein the joining member is at least one of crimped or molded onto the first and second tails.

17. The tissue anchor ofclaim 16, wherein the distal tip comprises a distal recess in which the joining member is seated.

18. The tissue anchor ofclaim 17, wherein the distal tip comprises a proximal shaft opposite the distal recess, the distal tip being received in the distal opening on account of the proximal shaft being received in the distal opening and residing in the passage.

19. The tissue anchor ofclaim 18, wherein the proximal shaft forms an interference fit with at least one of the distal opening or the passage.

20. The tissue anchor ofclaim 18, wherein the first and second spaced-apart channels extend longitudinally along the proximal shaft.

21. The tissue anchor ofclaim 18, wherein the aperture is defined between the flexible elongated element and a proximal end of the proximal shaft of the distal tip.

22. The tissue anchor ofclaim 5, wherein a maximum height of the aperture in a non-deflected state and extending parallel to the longitudinal axis of the passage is defined between the flexible elongated element and a proximal end of the distal tip, and the maximum height of the aperture is between a height of the proximal end of the tissue anchor and a height of the proximal end of the body plus a thickness of a soft tissue, the soft tissue proximal to the proximal end of the body.

23. The tissue anchor as in any ofclaim 2 or5, in which a maximum width of the aperture in a non-deflected state is defined between the first and second spaced-apart locations, and the maximum width of the aperture is approximately the maximum width of the passage, the maximum width of the aperture extending perpendicular to the longitudinal axis of the passage.

24. The tissue anchor as in any ofclaim 2 or5, in which a most proximal extent of the flexible elongated element in a non-deflected state is recessed distally within the passage from the proximal opening up to approximately a thickness of a suture mass to be passed through the aperture.

25. The tissue anchor as in any ofclaim 2 or5, in which the proximal opening is configured to interface with an insertion tool.

26. The tissue anchor as in any ofclaim 2 or5, in which the flexible elongated element comprises a suture.

27. The tissue anchor ofclaim 26, wherein the suture is a braided suture formed of a material comprising polyethylene, the material further comprising a thickness of between approximately 0.008″ and approximately 0.045″.

28. The tissue anchor ofclaim 26, wherein the suture is at least one of heat treated, coated or impregnated to at least one of stiffen or shape the suture.

29. The tissue anchor as in any ofclaim 2 or5, in which the flexible elongated element comprises a wire or monofilament.

30. The tissue anchor as in any ofclaim 2 or5, in which the flexible elongated element extends through a sheath.

31. The tissue anchor as in any ofclaim 2 or5, in which the flexible elongated element extends along a U-shaped channel member.

32. The tissue anchor as in any ofclaim 2 or5, in which a segment of polymer or metal extends through a lumen of the flexible elongated element.

33. The tissue anchor ofclaim 5, wherein a loop encircles a portion of the distal tip, the loop comprising the flexible elongated element, the aperture being defined between the flexible elongated element and a proximal end of the distal tip.

34. The tissue anchor ofclaim 33, wherein the loop further comprises a joining member joining together the first and second tails of the flexible elongated element, and the joining member is received in a distal recess of the distal tip.

35. The tissue anchor ofclaim 5, wherein the tissue anchor is a result of an assembly process comprising: a) assembling a tip assembly by causing a loop to encircle a portion of the distal tip, the loop comprising the flexible elongated element; and b) causing the tip assembly to be received in the distal opening of the body.

36. The tissue anchor ofclaim 35, wherein the loop further comprises a joining member joining together the first and second tails of the flexible elongated element, and the joining member is received in a distal recess of the distal tip as part of assembling the tip assembly.

37. The tissue anchor ofclaim 1, wherein the body further comprises a thread helically extending about an exterior of the body.

38. The tissue anchor ofclaim 37, wherein the thread comprises a double helix thread comprising two distinct threads offset approximately 180 degrees from each other.

39. The tissue anchor ofclaim 1, wherein the aperture has a minimum width to height ratio of three to one and a maximum width to height ratio of one to ten.

40. The tissue anchor ofclaim 1, wherein the flexible elongated element is configured to flex in a twisting rotation manner such that the aperture can accommodate different suture exchange attack angles.

41. The tissue anchor ofclaim 1, wherein the flexible elongated element is configured to flex in a twisting rotation manner such that a direction in which the aperture opens when the flexible elongated element is at maximum twisted rotation is between approximately 90 degrees and approximately 360 degrees from the direction in which the aperture opens when the flexible elongated element is in a non-deflected state.

42. The tissue anchor ofclaim 41, wherein the flexible elongated element is configured to maintain the aperture sufficiently open to accommodate suture exchange despite being at the maximum twisted rotation.

43. The tissue anchor ofclaim 1, wherein the flexible elongated element is configured to flex in a twisting rotation manner such that the aperture has no angles that are tighter than approximately 90 degrees when the flexible elongated element is at a twisted rotation of up to approximately 90 degrees from the direction in which the aperture opens when the flexible elongated element is in a non-deflected state.

44. The tissue anchor ofclaim 1, wherein the aperture is configured to accommodate a minimum mass throughput of 4 sutures.

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