# Patent

## Title
Method and apparatus for coupling soft tissue to a bone

## Abstract

A method and apparatus for surgically repairing a tear in soft tissue is disclosed. A plurality of collapsible tubes are positioned about the suture. The collapsible tubes are pushed through soft tissue and orthopedic mesh on opposite sides of a tear in soft tissue. When tension is applied to the suture, the tubes are compressed to fix the suture to the soft tissue and draw the soft tissue portions together.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional of U.S. patent application Ser. No. 12/489,168 filed Jun. 22, 2009, now issued as U.S. Pat. No. 8,361,113 which is a continuation-in-part application of: (1.) U.S. patent application Ser. No. 12/474,802 filed on May 29, 2009, now U.S. Pat. No. 8,088,130 issued on Jan. 3, 2012; (2.) U.S. patent application Ser. No. 11/541,506 filed on Sep. 29, 2006, now U.S. Pat. No. 7,601,165 issued on Oct. 13, 2009; (3.) U.S. patent application Ser. No. 11/541,505 filed on Sep. 29, 2006, now U.S. Pat. No. 7,658,751 issued on Feb. 9, 2010; (4.) U.S. patent application Ser. No. 12/014,399 filed on Jan. 15, 2008, now U.S. Pat. No. 7,909,851 issued on Mar. 22, 2011; (5.) U.S. patent application Ser. No. 12/014,340 filed on Jan. 15, 2008, now U.S. Pat. No. 7,905,904 issued on Mar. 15, 2011; (6.) U.S. patent application Ser. No. 11/935,681 filed on Nov. 6, 2007, now U.S. Pat. No. 7,905,903 issued on Mar. 15, 2011; (7.) U.S. patent application Ser. No. 11/869,440 filed on Oct. 9, 2007, now U.S. Pat. No. 7,857,830 issued on Dec. 28, 2010; (8.) U.S. patent application Ser. No. 11/784,821 filed on Apr. 10, 2007; (9.) U.S. patent application Ser. No. 11/347,661 filed on Feb. 3, 2006, now U.S. Pat. No. 7,749,250 issued on Jul. 6, 2010; (10.) U.S. patent application Ser. No. 11/347,662 filed on Feb. 3, 2006, now abandoned; (11.) U.S. patent application Ser. No. 12/196,405 filed on Aug. 22, 2008, now U.S. Pat. No. 8,128,658 issued on Mar. 6, 2012; (12.) U.S. patent application Ser. No. 12/196,407, filed on Aug. 22, 2008, now U.S. Pat. No. 8,137,382 issued on Mar. 20, 2012; and (13.) U.S. patent application Ser. No. 12/196,410, filed on Aug. 22, 2008, now U.S. Pat. No. 8,118,836 issued on Feb. 21, 2012.
The disclosures of the above applications are incorporated herein by reference.


FIELD
The present disclosure relates to method of coupling soft tissue to a bone and, more particularly, to a method of implanting an ACL within a femoral tunnel.
BACKGROUND
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
It is commonplace in arthroscopic procedures to employ sutures and anchors to secure soft tissues to bone. Despite their widespread use, several improvements in the use of sutures and suture anchors may be made. For example, the procedure of tying knots may be very time consuming, thereby increasing the cost of the procedure and limiting the capacity of the surgeon. Furthermore, the strength of the repair may be limited by the strength of the knot. This latter drawback may be of particular significance if the knot is tied improperly as the strength of the knot in such situations may be significantly lower than the tensile strength of the suture material.
To improve on these uses, sutures having a single preformed loop have been provided. FIG. 1 represents a prior art suture construction. As shown, one end of the suture is passed through a passage defined in the suture itself. The application of tension to the ends of the suture pulls a portion of the suture through the passage, causing a loop formed in the suture to close. Relaxation of the system, however may allow a portion of the suture to translate back through the passage, thus relieving the desired tension.
It is an object of the present teachings to provide an alternative device for anchoring sutures to bone and soft tissue. The device, which is relatively simple in design and structure, is highly effective for its intended purpose.
SUMMARY
To overcome the aforementioned deficiencies, a method for configuring a braided tubular suture and a suture configuration are disclosed. The method includes passing a first end of the suture through a first aperture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage. A second end of the suture is passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage.
A method of surgically implanting a suture construction in a femoral tunnel is disclosed. A suture construction is formed by passing the suture through a bore defined by a locking member. A first end of the suture is passed through a first aperture within the suture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage and define a first loop. A second end of the suture is then passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage, and define a second loop. The first and second ends and the first and second loops are then passed through the femoral tunnel. Soft tissue is then passed through the first and second loops. Tension is applied onto the first and second ends to constrict the first and second loops to pull the soft tissue into the tunnel.
In another embodiment, a method of surgically implanting a suture is disclosed. The suture is passed through a bore defined by a first fastener. A suture construction is formed by passing the suture through a bore defined by a locking member. A first end of the suture is passed through a first aperture within the suture into a passage defined by the suture and out a second aperture defined by the suture so as to place the first end outside of the passage and define a first loop. A second end of the suture is then passed through the second aperture into the passage and out the first aperture so as to place the second end outside of the passage, and define a second loop. A second fastener is coupled to at least one of the first and second loops. After the fastener is coupled to the patient, tension is applied onto the first and second ends to constrict at least one of the first and second loops.
In another embodiment a method of surgically implanting a soft tissue replacement for attaching two bone members is disclosed. A first and second tunnel is formed in first and second bones. A locking member having a first profile which allows insertion of the locking member through the tunnel and a second profile which allows engagement with the positive locking surface upon rotation of the locking member is provided. The suture construction described above is coupled to the locking member. The first and second ends and the first and second loops of the construction and the locking member are threaded through the first and second tunnels. Soft tissue is threaded through the first and second loops so as to engage bearing surfaces on the first and second loops. The locking member is then engaged.
Further areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.



DRAWINGS
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way.
FIG. 1 represents a prior art suture configuration;
FIGS. 2A and 2B represent suture constructions according to the teachings;
FIG. 3 represents the formation of the suture configuration shown in FIG. 4A;
FIGS. 4A and 4B represent alternate suture configurations;
FIGS. 5-7 represent further alternate suture configurations;
FIG. 8 represents the suture construction according to FIG. 5 coupled to a bone engaging fastener;
FIGS. 9-11B represent the coupling of the suture construction according to FIG. 5 to a bone screw;
FIGS. 12A-12E represent the coupling of a soft tissue to an ACL replacement in a femoral/humeral reconstruction;
FIGS. 13A-13D represent a close-up view of the suture shown in FIGS. 1-11C;
FIGS. 14-16 represent fixed length textile anchors;
FIGS. 17-21 represent adjustable length textile anchors according to the teachings herein;
FIGS. 22-24 represent alternate adjustable length textile anchors;
FIGS. 25-27 represent alternate suture configurations;
FIG. 28 represents the preparation of the tibia and femur to accept the anchors disclosed in FIGS. 14-24;
FIGS. 29A and 29B represent the coupling of an ACL replacement in a femoral/tibial reconstruction using the textile anchor of FIG. 18;
FIGS. 30A and 30B represent the coupling of an ACL replacement in a femoral/tibial reconstruction using the textile anchor of FIG. 17;
FIGS. 31A and 31B represent the coupling of an ACL replacement in the femoral/tibial reconstruction using the textile anchor of FIG. 15;
FIGS. 32A and 32B represent the coupling of an ACL replacement in a femoral/humeral reconstruction using the textile anchor of FIG. 16;
FIG. 33 represents a suture construction having a plurality of collapsible tubes;
FIGS. 34A-34C represent a tool used to surgically implant the suture construction shown in FIG. 33;
FIGS. 35A-35C show the suture construction of FIG. 33 coupled to an orthopedic mesh;
FIGS. 36A-36C represent the use of an orthopedic mesh to repair a soft tissue tear;
FIGS. 37A-39D represent various methodologies of coupling the suture constructions of FIG. 33 to soft tissue; and
FIGS. 40-45 represent an alternate suture construction.



DETAILED DESCRIPTION
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses. It should be understood that throughout the drawings, corresponding reference numerals indicate like or corresponding parts and features.
FIG. 2A represents a suture construction 20 according to the present teachings. Shown is a suture 22 having a first end 24 and a second end 26. The suture 22 is formed of a braided body 28 that defines a longitudinally formed hollow passage 30 therein. First and second apertures 32 and 34 are defined in the braided body 28 at first and second locations of the longitudinally formed passage 30.
Briefly referring to FIG. 3, a first end 24 of the suture 22 is passed through the first aperture 32 and through longitudinal passage 30 formed by a passage portion and out the second aperture 34. The second end 26 is passed through the second aperture 34, through the passage 30 and out the first aperture 32. This forms two loops 46 and 46′. As seen in FIG. 2B, the relationship of the first and second apertures 32 and 34 with respect to the first and second ends 24 and 26 can be modified so as to allow a bow-tie suture construction 36. As described below, the longitudinal and parallel placement of first and second suture portions 38 and 40 of the suture 22 within the longitudinal passage 30 resists the reverse relative movement of the first and second portions 38 and 40 of the suture once it is tightened.
The first and second apertures are formed during the braiding process as loose portions between pairs of fibers defining the suture. As further described below, the first and second ends 24 and 26 can be passed through the longitudinal passage 30 multiple times. It is envisioned that either a single or multiple apertures can be formed at the ends of the longitudinally formed passage.
As best seen in FIGS. 4A and 4B, a portion of the braided body 28 of the suture defining the longitudinal passage 30 can be braided so as to have a diameter larger than the diameter of the first and second ends 24 and 26. Additionally shown are first through fourth apertures 32, 34, 42, and 44. These apertures can be formed in the braiding process or can be formed during the construction process. In this regard, the apertures 32, 34, 42, and 44 are defined between adjacent fibers in the braided body 28. As shown in FIG. 4B, and described below, it is envisioned the sutures can be passed through other biomedically compatible structures.
FIGS. 5-7 represent alternate constructions wherein a plurality of loops 46a-d are formed by passing the first and second ends 24 and 26 through the longitudinal passage 30 multiple times. The first and second ends 24 and 26 can be passed through multiple or single apertures defined at the ends of the longitudinal passage 30. The tensioning of the ends 24 and 26 cause relative translation of the sides of the suture with respect to each other.
Upon applying tension to the first and second ends 24 and 26 of the suture 22, the size of the loops 46a-d is reduced to a desired size or load. At this point, additional tension causes the body of the suture defining the longitudinal passage 30 to constrict about the parallel portions of the suture within the longitudinal passage 30. This constriction reduces the diameter of the longitudinal passage 30, thus forming a mechanical interface between the exterior surfaces of the first and second parallel portions as well as the interior surface of the longitudinal passage 30.
As seen in FIGS. 8-11, the suture construction can be coupled to various biocompatible hardware. In this regard, the suture construction 20 can be coupled to an aperture 52 of the bone engaging fastener 54. Additionally, it is envisioned that soft tissue or bone engaging members 56 can be fastened to one or two loops 46. After fixing the bone engaging fastener 54, the members 56 can be used to repair, for instance, a meniscal tear. The first and second ends 24, 26 are then pulled, setting the tension on the loops 46, thus pulling the meniscus into place. Additionally, upon application of tension, the longitudinal passage 30 is constricted, thus preventing the relaxation of the tension caused by relative movement of the first and second parallel portions 38, 40, within the longitudinal passage 30.
As seen in FIGS. 9-11B, the loops 46 can be used to fasten the suture construction 20 to multiple types of prosthetic devices. As described further below, the suture 22 can further be used to repair and couple soft tissues in an anatomically desired position. Further, retraction of the first and second ends allows a physician to adjust the tension on the loops between the prosthetic devices.
FIG. 11B represents the coupling of the suture construction according to FIG. 2B with a bone fastening member. Coupled to a pair of loops 46 and 46′ is tissue fastening members 56. The application of tension to either the first or second end 24 or 26 will tighten the loops 46 or 46′ separately.
FIGS. 12A-12E represent potential uses of the suture constructions 20 in FIGS. 2A-7 in an ACL repair. As can be seen in FIG. 12A, the longitudinal passage portion 30 of suture construction 20 can be first coupled to a fixation member 60. The member 60 can have a first profile which allows insertion of the member 60 through the tunnel and a second profile which allows engagement with a positive locking surface upon rotation. The longitudinal passage portion 30 of the suture construction 20, member 60, loops 46 and ends 24, 26 can then be passed through a femoral and tibial tunnel 62. The fixation member 60 is positioned or coupled to the femur. At this point, a natural or artificial ACL 64 can be passed through a loop or loops 46 formed in the suture construction 20. Tensioning of the first and second ends 24 and 26 applies tension to the loops 46, thus pulling the ACL 64 into the tunnel. In this regard, the first and second ends are pulled through the femoral and tibial tunnel, thus constricting the loops 46 about the ACL 64 (see FIG. 12B).
As shown, the suture construction 20 allows for the application of force along an axis 61 defining the femoral tunnel. Specifically, the orientation of the suture construction 20 and, more specifically, the orientation of the longitudinal passage portion 30, the loops 46, and ends 24, 26 allow for tension to be applied to the construction 20 without applying non-seating forces to the fixation member 60. As an example, should the loops 24, 26 be positioned at the member 60, application of forces to the ends 24, 26 may reduce the seating force applied by the member 60 onto the bone.
As best seen in FIG. 12C, the body portion 28 and parallel portions 38, 40 of the suture construction 20 remain disposed within to the fixation member 60. Further tension of the first ends draws the ACL 64 up through the tibial component into the femoral component. In this way, suture ends can be used to apply appropriate tension onto the ACL 64 component. The ACL 64 would be fixed to the tibial component using a plug or screw as is known. The suture construction has loops 46 and 46′ with a first length which allows rotation of the fixation member 60. Application of tension onto the ends 24, 26 of the sutures pulls the fixation member 60 into position and the loops 46 and 46′ into a second length. In this position, rotation of the locking member in inhibited.
After feeding the ACL 64 through the loops 46, tensioning of the ends allows engagement of the ACL with bearing surfaces defined on the loops. The tensioning pulls the ACL 64 through a femoral and tibial tunnel. The ACL 64 could be further coupled to the femur using a transverse pin or plug. As shown in FIG. 12E, once the ACL is fastened to the tibia, further tensioning can be applied to the first and second ends 24, 26 placing a desired predetermined load on the ACL. This tension can be measured using a force gauge. This load is maintained by the suture configuration. It is equally envisioned that the fixation member 60 can be placed on the tibial component 66 and the ACL pulled into the tunnel through the femur. Further, it is envisioned that bone cement or biological materials may be inserted into the tunnel 62.
FIGS. 13A-13D represent a close-up of a portion of the suture 20. As can be seen, the portion of the suture defining the longitudinal passage 30 has a diameter d1 which is larger than the diameter d2 of the ends 24 and 26. The first aperture 32 is formed between a pair of fiber members. As can be seen, the apertures 32, 34 can be formed between two adjacent fiber pairs 68, 70. Further, various shapes can be braided onto a surface of the longitudinal passage 30.
The sutures are typically braided of from 8 to 16 fibers. These fibers are made of nylon or other biocompatible material. It is envisioned that the suture 22 can be formed of multiple type of biocompatible fibers having multiple coefficients of friction or size. Further, the braiding can be accomplished so that different portions of the exterior surface of the suture can have different coefficients of friction or mechanical properties. The placement of a carrier fiber having a particular surface property can be modified along the length of the suture so as to place it at varying locations within the braided constructions.
FIGS. 14-16 represent collapsible anchors 70, 72, 74 according to the present teachings. The anchors are deformable from a first cross section to a second engaging cross section. The anchors 70, 72, 74 are biocompatible materials for example polymer or a knit or woven textile such as a braided nylon material. Disposed within a collapsible tube 76 is a closed loop of suture material 78 which may form a portion of the collapsible tube 76. Optionally, this collapsible tube 76 can be slidable with respect to the closed loop of suture material 78. The collapsible tube 76 is further collapsible to form a fabric mass 110 (see for example FIG. 29B).
The suture material 78 can be passed through a pair of openings 83 in the collapsible tube 76 a single time to form a single soft tissue bearing surface 80. Additionally, (see FIG. 15), the closed loop of the suture material 78 can be looped over itself and passed through the collapsible flexible tube 76 to form a pair of soft tissue bearing surface portions 82. In each of the embodiments shown, the collapsible tube 76 defines at least one tube bearing surface.
FIG. 16 represents a closed loop of suture 78 passed through an aperture 77 defined in a body 79 of the collapsible tube 76. In this regard, the suture 78 is passed through a first open end 95 of the tube 78 and through the aperture 77 leaving a portion 81 of the collapsible tube 76 which can be used to assist in the insertion of a graft to a patient (see FIG. 32A).
FIGS. 17-19 represent adjustable sized loops of suture material 78 disposed within the collapsible tube 76 so as to form a suture anchor assembly 84, 86, 88. FIG. 17 shows the suture material 78 passed several times through the collapsible tube 76. By applying tension to the ends 90 and 92 of the suture material 78, the loops of the suture material constrict. If placed adjacent to a bearing surface (not shown), the end 94 and 96 of the collapsible tube 76 are brought together, thus collapsing the tube to form a collapsed material or fabric mass 110. It is envisioned a portion of the suture material 78 can be passed through the collapsible tube 76 to help maintain the position of the suture with respect to the collapsible tube 76.
FIGS. 18 and 19 show the loops of the suture construction of FIG. 4a within a collapsible tube 76. The tubular portion of the construction of FIG. 4a can be disposed either within or outside of the collapsible tube 76. As with the embodiment shown in FIGS. 14-16, translation of the tube 76 with respect to the suture material 78 can cause the ends 94 of the tube 76 to be brought together to compress the loops into a fabric mass 110.
FIGS. 20 and 21 show the loops of FIG. 2B, 4A or 5 disposed within the collapsible tube 76. Shown are the ends and loops disposed at least partially through a portion 100 of the tube 76. Tensioning of the ends 24, 26 causes the portions 100 of the tube 76 to collapse to form a mass 110, while leaving other portions 85 uncollapsed. The outer uncollapsed portion 85 can function as a bearing surface to assist in the collapse of portion 100 when portion 100 is subjected to compressive loads.
FIG. 21 shows an embodiment where suture loops are passed through the sidewalls of the collapsible tube 76. Optionally, the loops 46 and 47 as well as the ends 24 and 26 can be passed through together. This construction can be used in situations where a large collapsed mass 110 is needed
FIG. 22 shows the loop of FIG. 2B having a pair of collapsible tubes 76. The collapsible tubes 76 are disposed about the loops 46 and 46′ and will collapse upon application of tension to the ends of the suture construction in a manner which places compressive loads onto the ends of the tube 76. It is envisioned that these collapsible tubes 76 can be collapsed simultaneously or staggered in time as needed by a treating physician. It is also envisioned that the loop construction can be used to pull adjacent portions of a patient's anatomy together.
FIG. 23 depicts the loop construction shown in FIG. 2A having its loops disposed through a pair of co-joined crossed collapsible tubes 76. If placed adjacent to a bearing surface, the ends of the co-joined tubes come together, thus increasing in cross-section. This forms the fabric mass 110. This construction can be used in situations where a large collapsed mass is needed.
FIG. 24 shows the complex suture construction which embodies a pair of suture constructions of FIG. 2A coupled together using a collapsible tube 76. The ends of the suture 22 can be passed though a pair of passages 30 and 30′ formed in the suture material 22. Portions of the suture 22 are looped through each other to form a pair of locked loops 112. This construction can be used to provide a static seat for a graft bearing surface.
FIGS. 25-27 represent alternate suture constructions where the ends of the sutures 22 are fed multiple times through holes 105 defined within longitudinal passage 30 of the suture to form adjustable loops 46. In situations where relaxation of a tightened construction is to be minimized, the ends can be passed in and out of the passage 30 several times. In this regard, the first and second ends are positioned so as to be parallel and adjacent to each other in the passage 30.
FIGS. 26 and 27 represent constructions where the first and second ends 24 and 26 a passed through the same passage 30, but do not overlap and are not adjacent. This construction may be useful for joining pairs of members. This construction would be useful to bind pairs of appendages such as fingers.
FIG. 28 represents the formation of a femoral tunnel shown as a tunnel 62 having a varying diameter. Disposed within either the femoral or tibial tunnel 62 are a first portion 102 having a first diameter and a second portion 104 having a second diameter larger than the first diameter. Defined on an exterior surface of either the tibia or femur is a bearing surface 103, which is configured to interface with the fabric mass 110 of compressed textile material to prevent the relative motion of the fabric mass 110, and thus the suture construction with respect to the bone. This bearing surface can be machined or natural.
FIGS. 29A and 29B represent potential uses of the suture construction 86 in FIG. 18 in an ACL repair. As can be seen in FIG. 29A, the longitudinal passage portion 30 of suture construction 86 can be first coupled to a collapsible tube 76. The tube 76 can have a first profile which allows insertion of the tube 76 through the tunnel 62 and a second cross-sectional profile which allows engagement with a positive locking surface 103 upon collapse of the collapsible tube 76 into the fabric mass 110. The longitudinal passage portion 30 of the suture construction 84, tube 76, loops 46 and ends 24, 26 can then be pulled through a femoral and tibial tunnel 62. The tube 76 is positioned or coupled to the femur. At this point, a natural or artificial ACL 64 can be passed through a loop or loops 46 formed in the suture construction 20 or can be supported by the passage portion 30. Tensioning of the first and second ends 24 and 26 applies tension to the loops 46 and 47, thus pulling the ACL 64 into the tunnel. In this regard, the first and second ends are pulled through the femoral and tibial tunnel 62, thus constricting the loops 46 about the ACL 64.
After feeding the ACL 64 through the loops 46, tensioning of the ends allows engagement of the ACL with bearing surfaces defined on the loops. The tensioning pulls the ACL 64 through a femoral and tibial tunnel and collapses the tube 76 to form a locking fabric mass 110 outside the bone or tunnel 62. The ACL 64 could be further coupled to the femur or tibia using a transverse pin or plug. As shown in FIG. 29B, once the ACL is fastened to the tibia, further tensioning can be applied to the first and second ends 24, 26 placing a desired predetermined load on the ACL. As described above, this tension can be measured using a force gauge. This load is maintained by the suture configuration. It is equally envisioned that the fixation member 60 can be placed on the tibial component 66 and the ACL pulled into the tunnel through the femur. Further, it is envisioned that bone cement or biological materials may be inserted into the tunnel 62. The longitudinal passage 30 resists relaxation or reverse movement of the suture.
As best seen in FIG. 29B, the body portion 28 and parallel portions 38, 40 of the suture construction 86 remain disposed within the femoral tunnel 62. Further tension of the first ends draws the ACL 64 up through the tibial component into the femoral component. In this way, suture ends can be used to apply appropriate tension onto the ACL 64 component. The ACL 64 would be fixed to the tibial component using a plug or screw either before or after the application of the tension to the suture 22. Additionally, tension can be set on the ACL 64 after the collapsible tube 76 has been compressed.
FIGS. 30A and 30B represent potential uses of the suture constructions 84 in FIG. 17 in an ACL repair. As can be seen in FIG. 30A, the longitudinal passage portion 30 of suture construction 86 can be first disposed within the tube 76. The tube 76 has a first profile which allows insertion of the tube 76 through the tunnel and a second collapsed profile which allows engagement with a positive locking surface 103. The collapsible tube 76 of the suture construction 84, member 60, and loops 46, 47 can then be passed through a femoral and tibial tunnel 62 using a suture 108. The tube 76 is positioned or coupled to the femur. At this point, a natural or artificial ACL 64 can be passed through a loop or loops 46, 47 formed in the suture construction 84. Tensioning of the first and second ends 24 and 26 applies tension to the loops 46, 47 thus pulling the ACL 64 into the tunnel. In this regard, the first and second ends 26 and 24 are pulled through the femoral and tibial tunnel, thus constricting the loops 46 about the ACL 64 (see FIG. 30B) and collapsing the tube 76 to form the anchoring mass 110. Force applied to graft 64 along axis 61 in the distal direction will seat tube 76 and form anchoring mass 110.
As shown, by holding the suture construction in place 108, the suture construction 84 allows for the application of force along an axis 61 defining the femoral tunnel 62. Specifically, the orientation of the suture construction 84 and, more specifically, the orientation of the longitudinal passage portion 30, the loops 46, and ends 24, 26 allow for tension to be applied to the construction 86 without applying non-seating forces to the tube 76. As an example, should the loops 24, 26 be positioned at the tube 76, application of forces to the ends 24, 26 may reduce the seating force applied by the tube 76 onto the bone.
As best seen in FIG. 30B, the loop portions 46, 47 of the suture construction 84 remain disposed within to the tunnel 62. Further tension of the first ends draws the ACL 64 up through the tibial component into the femoral component. In this way, suture ends can be used to apply appropriate tension onto the ACL 64 component. The ACL 64 would be fixed to the tibial component using a plug or screw 60 adjacent the suture construction 84, as is known.
Alternatively, as shown in FIG. 30B, once the ACL is fastened to the tibia, further tensioning can be applied to the first and second ends 24, 26 placing a desired predetermined load on the ACL. This load is maintained by the suture configuration. It is equally envisioned that the fixation member 60 can be placed on the tibial component 66 and the ACL pulled into the tunnel through the femur. Further, it is envisioned that bone cement or biological materials may be inserted into the tunnel 62.
FIGS. 31A and 31B represent potential uses of the suture construction 70 in FIG. 14 in an ACL repair. The suture material 78 of suture construction 70 can be first coupled to a collapsible tube 76. The collapsible tube 76 can have a first profile which allows insertion of the construction 70 through the tunnel and a second profile which allows engagement with a positive locking surface 103 upon its compression. Prior to attachment to the femur, a natural or artificial ACL 64 can be passed through a loop or loops 46 formed in the suture material 78. Suture construction 70 can then be passed through a femoral and tibial tunnel 62. The tube 76 is positioned or coupled to the femur. Tensioning of the first and second ends 112 and 114 of the soft tissue applies tension to the loop 76, thus collapsing the tube 76 to form the fabric mass 110. Tension can be applied to the soft tissue which can then be fastened to the tibia using a fastener 60.
FIGS. 32A and 32B represent potential uses of the suture constructions 74 in FIG. 16 in an ACL repair. The loop of suture 78 is coupled to a collapsible tube 76. The construction 74 can have a first profile which allows insertion of the tube 76 through the tunnel and a second profile which allows engagement with a positive locking surface upon compression. The suture portion 78 of the suture construction 74, tube 76, and soft tissue 64 can then be passed through a femoral and tibial tunnel 62. The tube 76 is positioned or coupled to the femur 103 and collapsed by the application of tension to the soft tissue 64.
As best seen in FIG. 32B, the anchoring mass 110 of the suture construction 72 remains disposed outside the femoral tunnel. Tension is applied to the ends of the ACL 64 up through the tibial component into the femoral component. In this way, ends of the ACL 112, 114 can be used to apply appropriate tension onto the ACL 64 component. The ACL 64 would be fixed to the tibial component using a plug or screw as is known.
FIG. 33 represents a suture construction 100 according to the present teachings. The suture construction 100 is formed of a suture 102 having a plurality of collapsible tubes 104 disposed thereon. The collapsible tubes 104 can be knit suture material or a polymer tube. Formed on one or both ends of the suture 102 can be a knot 106. Optionally, the collapsible tube 104 can be coupled to the suture 102 using a stitch 108, to prevent translation of the collapsible tube 104 with respect to the suture 102.
FIGS. 34A-34C represent a tool 110 used to couple the suture construction 100 with soft tissue. In this regard, the tool 110 has a sharpened end 112 configured to pierce soft tissue 124. Disposed adjacent the sharpened end 112 is a recess 114 configured to support a collapsible tube 104. Disposed within the recess 114 is a collapsible tube holding member 116. This member 116 can be a flange or a retractable member which selectively engages the collapsible tube 104 to hold the collapsible tube within the recess 114. Disposed within the tool 100 is an actuatable member 118. The actuatable member 118 functions to deploy or deliver the collapsible tube 104 from the holding member 116 of the recess 114. This generally occurs after the collapsible tube 104 has been pressed through the soft tissue 124.
As shown in FIG. 34C, the sharpened end 112 can be pressed through soft tissue 124, thus positioning the collapsible tube 104 on an obverse side of the soft tissue 124. Application of force by the drive member 120 onto the actuatable member 118 causes an engagable member 122 to deliver the collapsible tube 104 from the recessed portion 114 of the tool 110. the engagable member 122 can be formed of Nitonol or can be pivotably coupled to the actuatable member 118. At this point, the sharpened end can be removed from the soft tissue 124, leaving the compressible tube and its associated suture 102 therethrough.
As shown in FIGS. 35A-35C, multiple collapsible tubes 104 on the suture 102 can be inserted through multiple apertures formed within the soft tissue 124. Additionally shown is an implantable orthopedic mesh 130. As best seen in FIG. 35B, the sharp end 112 of the tool 110 can be fed through a single aperture 128 formed in a layer of soft tissue 120 such as skin. The sharp end 112 is pressed through several apertures within the soft tissue 124 and through apertures within the implantable orthopedic mesh 130. The application of tensional force onto the suture 102 allows the ends 131 of the collapsible tubes 104 to engage the orthopedic mesh 130. This allows the collapsible tube 104 to form a loop structure locking the suture to the mesh 130. Further, the mesh is coupled to the soft tissue 124, bone, skin, tendon, xenograft, allograft and autograft.
As best seen in FIG. 35C, once the collapsible tube 104 has been positioned through the orthopedic mesh 130, the needle is withdrawn to allow the engagement of the next collapsible tube 104 within the recess 114 of the tool 110. The tool 110 is moved to position the sharp end 112 in a desired location on the soft tissue 124. Pressure is then applied to the tool 110 forming a hole within the soft tissue 124.
As described above, once the recess portion 114 is passed through the soft tissue 124 or the orthopedic sports mesh 130, the actuator 118 can be used to decouple the collapsible tube 104 from the recessed portion 114. The sports mesh can be one sold by Biomet Sports Medicine as Sport MeshTM. This allows the removal of the tool 110 while leaving collapsible tube 104 and associated suture 102 on the obverse side of the soft tissue 124 and the orthopedic mesh 130. The orthopedic mesh can be formed of resorbable materials.
As shown in FIGS. 36A-36C, the construction in FIGS. 35A-35C and, particularly, the orthopedic mesh 130 can be used to repair torn soft tissue 124. In this regard, it is envisioned the mesh 130 can be placed over a muscle tear 132. A series of collapsible tubes 104 are disposed over a suture 102 and can be coupled to the soft tissue by pushing the collapsible tubes 104 through the soft tissue 124 and the mesh 130. Tension can be applied to the suture 102 to collapse the collapsible tube 104, thus coupling the sports mesh 130 to the two portions of soft tissue 124 which are being repaired.
As best seen in FIGS. 36B and 36C, several different stitching techniques can be used to couple multiple collapsible tubes 104 along the periphery of the orthopedic mesh 130 on either side of a tear 132. The orthopedic mesh 130 functions to distribute loads along the muscle 124, thus allowing the torn muscle 132 to heal properly.
As seen in FIG. 36C, sutures 134 can be added between the loops of collapsible tubes 104. It is envisioned that this functions to transfer loads from one portion of the muscle to a second, thus allowing the muscle tear 132 to heal more rapidly and compress the tear 132.
FIGS. 37A-39D represent various methods of inserting the suture constructions shown above into soft tissue. FIGS. 37A and 37B represent a collapsible tube having a single and double suture and constructions. These constructions are being threaded through a soft tissue 124, using a speed pass suture retriever from Biomet Sports Medicine. A passage is formed within a soft tissue 124 using the speed pass suture retriever has a deployable portion which can grab a suture and pull it through the passage. At this point, the suture construction having a suture 102 and collapsible tube is positioned within the speed pass and pulled through the aperture formed within the soft tissue 124. Tension is applied to the suture 102, thus collapsing the collapsible tube 104.
As seen in FIGS. 38A and 38B, by using a curved speed pass instrument, a pair of apertures can be formed within the soft tissue. The speed pass instrument is then used to pull the suture construction through the two apertures formed in the soft tissue 124. Alternatively, the suture construction may be pressed within the speed pass 125 and released (pushed out) after the speed pass 125 has pierced the soft tissue.
As seen in FIGS. 38A and 38B, the speed pass having a corkscrew shape can be used to form a pair of apertures in soft tissues which are generally perpendicular to the tool threading direction. In each of these conditions, tension is applied to the sutures 102 to compress the tubes 104. It is envisioned the speed pass can be used to feed the suture constructions through the orthopedic mesh as described above.
FIGS. 40-45 represent a tool 140 used to couple the suture construction 100 with soft tissue. In this regard, the tool 140 has a sharpened end 142 configured to pierce soft tissue 124. Disposed adjacent to the sharpened end 142 is a first portion 144 configured to support a collapsible tube anchor 146. Adjacent to the first portion 144 is a second portion 148 which can support a plurality of collapsible tube anchors 146. Disposed between the first 144 and second portions 148 is a generally conical portion 150. As shown in FIG. 41, the conical portion 150 facilitates movement of the collapsible tubes 146 from the second portion 148 to the first portion 144. Defined between the conical portion 150 and the first portion 144 is a generally flat or planar support surface 152. The flat surface 152 is configured to support and apply axial forces to an end 154 of the collapsible tube anchor 146.
As best seen in FIG. 43, the conical portion 150 can have an oblong cross-section. This cross-section can help facilitate the passing of the suture through the soft tissue. The sharpened end 142 can be passed through soft tissue 124, thus placing the collapsible tube 146 on an obverse side of the soft tissue 124. At this point, the sharpened end 142 can be passed through another soft tissue layer, a shorts mesh, or skin.
As shown in FIG. 45, the tool 140 can be withdrawn leaving the collapsible tube 146 on the obverse side of the soft tissue. Force can then be applied to the suture 156, as described above, to collapse the collapsible tube 146.
The description of the invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. For example, any of the above mentioned surgical procedures is applicable to repair of other body portions. For example, the procedures can be equally applied to the repair of wrists, elbows, ankles, and meniscal repair. The suture loops can be passed through bores formed in soft or hard tissue. It is equally envisioned that the loops can be passed through or formed around an aperture or apertures formed in prosthetic devices e.g. humeral, femoral or tibial stems. Such variations are not to be regarded as a departure from the spirit and scope of the invention.

## Claims

1. A tissue repair assembly for repairing tissue comprising:
a suture construct extending from a first end to a second end and formed from a body defining a longitudinally formed hollow passage, the first end of the suture construct extending through a passage portion of the hollow passage to form a first adjustable loop and the second end of the suture construct extending through the passage portion of the hollow passage to form a second adjustable loop, wherein, with the first end of the suture construct extending through the passage portion of the hollow passage to form the first adjustable loop and with the second end of the suture construct extending through the passage portion of the hollow passage to form the second adjustable loop, the first end of the suture construct can be pulled through the passage portion of the hollow passage to decrease a length of the first adjustable loop and the second end of the suture construct can be pulled through the passage portion of the hollow passage to decrease a length of the second adjustable loop; and
a collapsible tube having a sidewall extending from a first end, to a middle section, and to a second end,
wherein the passage portion of the suture construct is disposed within the middle section of the collapsible tube.

2. The tissue repair assembly according to claim 1, wherein
the first end of the suture construct passes through a first aperture in the body, through the passage portion and out a second aperture in the body, forming the first adjustable loop; and
the second end of the suture construct passes through the second aperture in the body, through the passage portion and out the first aperture in the body, forming the second adjustable loop.

3. The tissue repair assembly according to claim 2, wherein the collapsible tube further defines a plurality of apertures at a plurality of locations on the sidewall along both ends of the collapsible tube.

4. The tissue repair assembly according to claim 3, wherein the first end and the second adjustable loop of the suture construct pass through a first tube aperture defined in the first end of the collapsible tube, and the second end and first adjustable loop of the suture construct pass through a second tube aperture defined in the second end of the collapsible tube.

5. The tissue repair assembly according to claim 4, wherein the first end and the second adjustable loop, and the second end and the first adjustable loop further pass through a plurality of apertures at the plurality of locations along the first and second ends of the collapsible tube, respectively, to form an accordion-type configuration.

6. The tissue repair assembly according to claim 5, wherein tensioning the ends of the suture construct causes portions of the collapsible tube to collapse to form a mass when an object has been placed through the loops, preventing the loops from re-entering the collapsible tube.

7. The tissue repair assembly according to claim 4, wherein the first tube aperture and the second tube aperture extend transversely through the first end and the second end of the collapsible tube, respectively.

8. The tissue repair assembly according to claim 1, wherein the adjustable loops are self-locking.

9. The tissue repair assembly according to claim 1, wherein
the first end of the suture construct passes through a first aperture in the body, through the passage portion and out a second aperture in the body, forming the first adjustable loop; and
the second end of the suture construct passes through a third aperture in the body, through the passage portion and out a fourth aperture in the body, forming the second adjustable loop.

10. The tissue repair assembly according to claim 1, wherein the body of the suture construct is formed as a braided body.

11. A tissue repair assembly for repairing tissue comprising:
a suture construct extending from a first end to a second end and formed from a braided body defining a longitudinally formed hollow passage, the braided body defining a first aperture at a first location and a second aperture at a second location on the braided body, wherein the first end of the suture construct passes through the second aperture, through a passage portion of the hollow passage, and out the first aperture to form a first loop, and the second end of the suture construct passes through the first aperture, through the passage portion of the hollow passage, and out the second aperture to form a second loop, wherein the first and second loops are self-locking and adjustable, wherein, with the first end of the suture construct passing through the passage portion of the hollow passage to form the first loop and with the second end of the suture construct passing through the passage portion of the hollow passage to form the second loop, the first end of the suture construct can be passed further through the passage portion of the hollow passage to decrease a length of the first loop and the second end of the suture construct can be passed further through the passage portion of the hollow passage to decrease a length of the second loop; and
a collapsible tube having a sidewall extending from a first end, to a middle section, and to a second end, the collapsible tube defining a plurality of apertures in the sidewall at the first and second ends,
wherein the passage portion of the suture construct is disposed within the middle section of the collapsible tube.

12. The tissue repair assembly according to claim 11, wherein the first end and second loop of the suture construct pass through a first tube aperture defined in the first end of the collapsible tube, and the second end and first loop of the suture construct pass through a second tube aperture defined in the second end of the collapsible loop.

13. The tissue repair assembly according to claim 12, wherein the first end and the second loop, and the second end and the first loop further pass through a plurality of apertures at a plurality of locations along the first and second ends of the collapsible tube, respectively, to form an accordion-type configuration.

14. The tissue repair assembly according to claim 13, wherein applying tension to the ends of the suture construct causes portions of the collapsible tube to collapse, leaving other portions of the collapsible tube uncollapsed, wherein the uncollapsed portions can function as a bearing surface to assist in the collapse of the collapsed portions when the collapsed portions are subjected to compressive loads.

15. The tissue repair assembly according to claim 13, wherein tensioning the ends of the suture construct causes portions of the collapsible tube to collapse to form a mass when an object has been placed through the loops, preventing the loops from re-entering the collapsible tube.

16. A tissue repair assembly comprising:
a suture construct comprising a suture extending from a first end to a second end, and formed from a braided body defining a longitudinally formed hollow passage, and having first and second apertures defined in the braided body at first and second locations of the longitudinally formed passage, wherein the first end of the suture construct passes through the first aperture, through a passage portion of the hollow passage, and out the second aperture to form a first loop, and the second end of the suture construct passes through the second aperture, through the passage portion of the hollow passage, and out the first aperture to form a second loop, wherein, with the first end of the suture construct passing through the passage portion of the hollow passage to form the first loop and with the second end of the suture construct passing through the passage portion of the hollow passage to form the second loop, the first end of the suture construct can be passed further through the passage portion of the hollow passage to decrease a length of the first loop and the second end of the suture construct can be passed further through the passage portion of the hollow passage to decrease a length of the second loop; and
a collapsible tube having a sidewall extending from a first end, to a middle section, and to a second end, the collapsible tube defining a plurality of apertures in the sidewall along the first and second ends,
wherein the passage portion of the suture construct is disposed within the middle section of the collapsible tube, and the first loop of the suture construct passes through a first tube aperture defined in the first end of the collapsible tube, and the second loop of the suture construct passes through a second tube aperture defined in the second end of the collapsible loop.

17. The tissue repair assembly according to claim 16, wherein the first loop and the second loop pass through the plurality of apertures at a plurality of locations along the first and second ends of the collapsible tube to form an accordion-type configuration.

18. The tissue repair assembly according to claim 17, wherein applying tension to the ends of the suture construct causes portions of the collapsible tube to collapse, leaving other portions of the collapsible tube uncollapsed, wherein the uncollapsed portions can function as a bearing surface to assist in the collapse of the collapsed portions when the collapsed portions are subjected to compressive loads.

19. The tissue repair assembly according to claim 17, wherein tensioning the ends of the suture construct causes portions of the collapsible tube to collapse to form a mass when an object has been placed through the loops, preventing the loops from re-entering the collapsible tube.

20. The tissue repair assembly according to claim 16, wherein the first loop and the second loop are self-locking and adjustable.

21. A tissue repair assembly for repairing tissue comprising:
a collapsible fixation member extending from a first end to a second end and defining a plurality of apertures extending through the collapsible fixation member between the first end and the second end; and
a suture extending from a first suture end to a second suture end, the suture extending through the plurality of apertures in the collapsible fixation member, wherein the collapsible fixation member forms S-shaped curved portions along a length of the suture between the first suture end and the second suture end,
wherein the suture is a suture construct formed from a braided body defining a longitudinally formed hollow passage, the first suture end extending through a passage portion of the hollow passage to form a first adjustable loop and the second suture end extending through the passage portion of the hollow passage to form a second adjustable loop, wherein, with the first suture end extending through the passage portion of the hollow passage to form the first adjustable loop and with the second suture end extending through the passage portion of the hollow passage to form the second adjustable loop, the first suture end can be pulled through the passage portion of the hollow passage to decrease a length of the first adjustable loop without decreasing a length of the second adjustable loop and the second suture end can be pulled through the passage portion of the hollow passage to decrease the length of the second adjustable loop without decreasing the length of the first adjustable loop.

22. The tissue repair assembly according to claim 21, wherein the collapsible fixation member is formed as a braided collapsible fixation member.

23. The tissue repair assembly according to claim 21, wherein the suture includes a middle section between the first suture end and a second suture end, where the first suture end extends from the middle section and the second suture end extends from the middle section substantially parallel to the first suture end to form a substantially U-shaped suture configuration, wherein the S-shaped curved portions of the collapsible fixation member are formed along the U-shaped suture configuration.

24. The tissue repair assembly according to claim 21, wherein at least a portion of the plurality of apertures extending through the collapsible fixation member extend substantially transversely through the collapsible fixation member.

25. The tissue repair assembly according to claim 21, wherein the first suture end passes through a first aperture in the braided body, through the passage portion and out a second aperture in the braided body, to form the first adjustable loop, and wherein the second suture end passes through the second aperture in the braided body, through the passage portion and out the first aperture in the braided body, to form the second adjustable loop.

26. The tissue repair assembly according to claim 21, wherein tensioning the suture ends causes the collapsible fixation member to collapse to form a mass.

27. The tissue repair assembly according to claim 21, wherein the S-shaped curved portions forms a collapsible accordion-type configuration to form a fixation mass.

28. A tissue repair assembly for repairing tissue comprising:
a suture having a first suture end portion, a second suture end portion, and a middle suture portion between the first and second suture end portions, the first suture end portion extending substantially parallel to the second suture end portion from the suture middle portion to form a substantially U-shaped suture configuration; and
a collapsible fixation member extending from a first end to a second end and defining a plurality of apertures extending through the collapsible fixation member between the first end and the second end, the suture extending through the plurality of apertures, wherein the collapsible fixation member forms S-shaped curved portions along the U-shaped suture configuration,
wherein the suture is a suture construct formed from a braided body defining a longitudinally formed hollow passage, the first suture end extending through a passage portion of the hollow passage to form a first adjustable loop and the second suture end extending through the passage portion of the hollow passage to form a second adjustable loop, wherein, with the first suture end extending through the passage portion of the hollow passage to form the first adjustable loop and with the second suture end extending through the passage portion of the hollow passage to form the second adjustable loop, the first suture end can be pulled through the passage portion of the hollow passage to decrease a length of the first adjustable loop without decreasing a length of the second adjustable loop and the second suture end can be pulled through the passage portion of the hollow passage to decrease the length of the second adjustable loop without decreasing the length of the first adjustable loop.

29. The tissue repair assembly according to claim 28, wherein the collapsible fixation member is formed as a braided collapsible fixation member.

30. The tissue repair assembly according to claim 28, wherein at least a portion of the plurality of apertures extending through the collapsible fixation member extend substantially transversely through the collapsible fixation member.

31. The tissue repair assembly according to claim 28, wherein the S-shaped curved portions forms a collapsible accordion-type configuration to form a fixation mass.

32. The tissue repair assembly according to claim 28, wherein the first suture end passes through a first aperture in the braided body, through the passage portion and out a second aperture in the braided body, to form the first adjustable loop, and wherein the second suture end passes through a third aperture in the braided body, through the passage portion and out a fourth aperture in the braided body, to form the second adjustable loop.

33. The tissue repair assembly according to claim 28, wherein the S-shaped curved portions of the collapsible fixation member extend separately along the first suture end portion and the second suture end portion.

34. A tissue repair assembly for repairing tissue comprising:
a collapsible fixation member extending from a first end to a second end and defining a plurality of apertures extending through the collapsible fixation member between the first end and the second end; and
a suture extending from a first suture end to a second suture end, the suture extending through the plurality of apertures in the collapsible fixation member, wherein the collapsible fixation member forms a collapsible accordion-type configuration to form a fixation mass,
wherein the suture is a suture construct formed from a braided body defining a longitudinally formed hollow passage, the first suture end extending through a passage portion of the hollow passage to form a first adjustable loop and the second suture end extending through the passage portion of the hollow passage to form a second adjustable loop, wherein, with the first suture end extending through the passage portion of the hollow passage to form the first adjustable loop and with the second suture end extending through the passage portion of the hollow passage to form the second adjustable loop, the first suture end can be pulled through the passage portion of the hollow passage to decrease a length of the first adjustable loop without decreasing a length of the second adjustable loop and the second suture end can be pulled through the passage portion of the hollow passage to decrease the length of the second adjustable loop without decreasing the length of the first adjustable loop.

35. The tissue repair assembly according to claim 34, wherein at least a portion of the plurality of apertures extending through the collapsible fixation member extend substantially transversely through the collapsible fixation member.

36. The tissue repair assembly according to claim 34, wherein the suture includes a middle section between the first suture end and the second suture end, where the first suture end extends from the middle section and the second suture end extends from the middle section to form a substantially U-shaped suture configuration; wherein curved portions of the collapsible fixation member are formed along the U-shaped suture configuration.

37. The tissue repair assembly according to claim 34, wherein the plurality of apertures includes a first pair of adjacent apertures and a second pair of adjacent apertures, wherein the first pair of adjacent apertures compress against one another along the suture and the second pair of apertures compress against one another along the suture upon forming the fixation mass.