# Patent

## Title
Knotless tissue fixation assembly

## Abstract

An illustrative example inserter assembly for securing soft tissue in a position adjacent bone includes an inserter having a proximal end and distal end. The inserter includes a handle near the proximal end and a shaft between the handle and the distal end. An anchor body is situated near the distal end of the inserter. A suture includes a portion establishing a suture loop near the distal end where the suture loop is distal of the anchor body. The suture includes a portion within the shaft. The suture has two ends that protrude from the inserter near the proximal end.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This is a continuation of U.S. application Ser. No. 14/935,778 filed Nov. 9, 2015, which is a continuation of U.S. patent application Ser. No. 14/272,601 filed May 8, 2014, now U.S. Pat. No. 9,179,907, which is a continuation of U.S. patent application Ser. No. 13/765,218 filed Feb. 12, 2013, which is a divisional of U.S. application Ser. No. 13/182,893, filed Jul. 14, 2011, now U.S. Pat. No. 8,430,909, which is a continuation of U.S. application Ser. No. 12/022,868, filed Jan. 30, 2008, now U.S. Pat. No. 7,993,369, which is a continuation-in-part of U.S. application Ser. No. 10/405,707, filed Apr. 3, 2003, now U.S. Pat. No. 7,329,272, which is a continuation-in-part of U.S. application Ser. No. 09/886,280, filed Jun. 22, 2001, now U.S. Pat. No. 6,544,281, which claims the benefit of U.S. Provisional Application No. 60/213,263, filed Jun. 22, 2000.


BACKGROUND
When soft tissue such as a ligament or a tendon becomes detached from a bone, surgery is usually required to reattach or reconstruct the tissue. Often, a tissue graft is attached to the bone to facilitate regrowth and permanent attachment. Various fixation devices, including sutures, screws, staples, wedges, and plugs have been used in the past to secure soft tissue to bone. In typical interference screw fixation, for example, the graft is fixed to the bone by driving the screw into a blind hole or a tunnel in the bone while trapping the end of the graft between the screw and the bone tunnel. In other methods, the graft is simply pinned against the bone using staples or sutures tied around the end of the graft to the bone.
More recently, various types of threaded suture anchors have been developed. The application of such suture anchors generally requires the surgeon to tie knots in the suture to secure the tissue to the bone, which is tedious and time-consuming. The surgical procedure would be less cumbersome for the surgeon and ultimately more beneficial to the patient if the tissue could be attached to the bone without the surgeon having to tie suture knots.
SUMMARY
Illustrative embodiments disclosed below are useful for securing soft tissue to bone with excellent pull-out strength without requiring a surgeon to tie suture knots to secure the suture in place or to secure the tissue to the bone. The disclosed examples may be used to secure any type of soft tissue, graft, or tendon.
An illustrative example inserter assembly for securing soft tissue in a position adjacent bone includes an inserter having a proximal end and distal end. The inserter includes a handle near the proximal end and a shaft between the handle and the distal end. An anchor body is situated near the distal end of the inserter. A suture includes a portion establishing a suture loop near the distal end where the suture loop is distal of the anchor body. The suture includes a portion within the shaft. The suture has two ends that protrude from the inserter near the proximal end.
Another illustrative example tissue securing assembly includes an inserter with a distal end and a proximal end. The inserter includes a handle near the proximal end and has a longitudinal axis between the distal end and the proximal end. An anchor body near the distal end is configured to be received in a hole in bone for trapping at least a portion of soft tissue in bone. A tissue gathering portion is near the distal end and distal of the anchor body. The tissue gathering portion is configured to facilitate at least temporarily gathering a portion of soft tissue near the distal end of the inserter for moving the portion of soft tissue with the distal end of the inserter into a hole in bone. A second portion is coupled to the tissue gathering portion. The second portion extends along the longitudinal axis from the tissue gathering portion to near the proximal end. The second portion is at least partially within the inserter. The second portion is moveable relative to the handle to change a position of the tissue gathering portion relative to the anchor body.
An illustrative example method of securing soft tissue in a position adjacent bone involves an anchor assembly that includes an inserter, an anchor body near a distal end of the inserter, and a suture situated at least partially within the inserter. The suture establishes a suture loop near the distal end of the inserter. The method includes manipulating a portion of the suture that protrudes from the inserter near a proximal end of the inserter to capture a portion of the soft tissue within the suture loop; placing at least the suture loop and the portion of the soft tissue within a blind hole in bone; and causing relative motion between the suture loop and the anchor body to thereby secure the anchor body within the blind hole in a position where the anchor body traps at least the portion of the soft tissue in the bone.
In another example embodiment, a blind hole or socket is created in the bone at the location that the tissue is to be secured. Suture is passed through the tissue at desired points. A cannulated plug or screw is pre-loaded onto the distal end of a cannulated driver. In an example embodiment, a separate piece of suture is passed through the cannula of the driver, with a looped end of the suture exposed at the distal end of the driver. The ends of the suture attached to the tissue are fed through the suture loop at the end of the driver. Tension is placed on the suture to bring the tissue to an appropriate distance from the distal end of the driver. Here, the tissue is either brought to the distal end of the driver or spaced away from the distal end of the driver by a distance approximately equal to the length of the screw or plug. The distal end of the driver is inserted into the bottom of the hole, with the screw or plug disposed just outside the hole. Once adequate tension is achieved on the suture to keep the tissue at the desired location relative to the bone hole and the distal end of the plug or screw, the driver is pressed into the hole, engaging the first thread or bump of the screw or plug. The screw or plug is then fully advanced into the hole using the driver to frictionally secure either the suture attached to the tissue or the tissue itself into the bone hole. When the screw or plug is fully inserted, the suture loop is freed and the driver is removed. The loose ends of the sutures protruding from the anchor site are then clipped short.
Alternatively, the step of passing suture through the tissue may be omitted, so that the tissue itself is captured in the suture loop to be directly affixed into the fixation hole.
Various features and advantages associated with disclosed embodiments of the present invention will become apparent from the following detailed description, which refers to the accompanying drawings.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates a proximal end, side elevational view of an interference screw according to an embodiment of the present invention.
FIG. 2 is a proximal end view of the screw shown in FIG. 1.
FIG. 3 is a cross-sectional view, drawn along line III-III of FIG. 2, of the screw shown in FIG. 1.
FIG. 4 illustrates a side elevational view of an interference plug according to an embodiment of the present invention.
FIG. 5 is a cross-sectional view of the plug shown in FIG. 4.
FIG. 6 is a distal end view of the plug shown in FIG. 6.
FIG. 7 illustrates a driver according to an embodiment of the present invention for driving the interference screw shown in FIG. 1.
FIG. 8 shows a handle according to a variation of the driver seen in FIG. 7.
FIG. 9 shows the inner shaft attachable to the driver handle shown in FIG. 8.
FIG. 10 shows the outer shaft of the driver according to an embodiment of the present invention.
FIG. 11 illustrates an alternative embodiment of a driver and an interference screw.
FIGS. 12A and 12B illustrate a driver according to an embodiment of the present invention usable for the interference plug shown in FIG. 4.
FIG. 13 illustrates a punch usable in connection with an embodiment of the present invention to create a bone socket for securing the graft.
FIG. 14 illustrates a graft to be secured to the bone with attached sutures, and a socket created in the bone at the location at which the graft is to be affixed.
FIG. 15 shows the driver of FIG. 7 loaded with an interference screw and having a traction suture loop formed near the distal end of the driver.
FIG. 16 illustrates the sutures attached to the graft being passed through the suture loop according to an embodiment of present invention.
FIG. 17 is a view through a cross-section of the bone socket which shows the sutures attached to the graft being held in contact with the bottom of the bone socket with the interference screw positioned just out of the socket.
FIG. 18A is a view through a cross-section of the bone through the socket.
FIG. 18B illustrates the same step of the invention as shown in FIG. 18A, but provides a close-up view from the surgeon's perspective.
FIG. 18C is a view like FIG. 18A showing soft tissue trapped between an anchor body and bone.
FIG. 19 shows the graft secured to the bone as a result of a method according to an embodiment of the present invention.
FIG. 20 illustrates an alternative embodiment of a method according to the present invention in which the sutures attached to the graft are threaded directly into and through the driver instead of through a suture loop at the distal end of the driver.
FIG. 21 illustrates a perspective view of a distal end of a push lock driver of an embodiment of the present invention.
FIG. 22 illustrates a perspective view of the push lock driver of FIG. 21.
FIG. 23 is a schematic cross-sectional view of a surgical site undergoing a graft fixation technique according to a method of an embodiment of the present invention.
FIG. 24 is a schematic view of the surgical site of FIG. 23 undergoing a graft fixation technique with the push lock driver of FIGS. 21 and 22.
FIG. 25 is a schematic view of the surgical site of FIG. 23 undergoing a graft fixation technique with the push lock driver of FIGS. 21 and 22 and at a stage subsequent to that shown in FIG. 24.
FIG. 26 is a schematic view of the surgical site of FIG. 23 undergoing a graft fixation technique with the push lock driver of FIGS. 21 and 22 and at a stage subsequent to that shown in FIG. 25.
FIG. 27 is a schematic view of the surgical site of FIG. 23 undergoing a graft fixation technique with the push lock driver of FIGS. 21 and 22 and at a stage subsequent to that shown in FIG. 26.
FIG. 28 is a schematic view of an eyelet implant of an embodiment of the present invention secured by and locked into an interference device in accordance with an embodiment of the present invention.
FIG. 29 illustrates a perspective view of a distal end of a push lock driver in accordance with an embodiment of the present invention.
FIG. 30 illustrates a perspective view of a distal end of a push lock driver in accordance with another embodiment of the present invention.
FIG. 31 illustrates a perspective view of a distal end of a push lock driver in accordance with another embodiment of the present invention.
FIG. 32 illustrates another perspective view of the push lock driver of FIG. 31 with a strand passed through an aperture of the push lock.
FIG. 33 is a schematic cross-sectional view of a surgical site undergoing a graft fixation technique with the push lock driver of FIGS. 31 and 32.
FIGS. 34 and 34A are schematic views of the surgical site of FIG. 33 at a graft fixation stage subsequent to that shown in FIG. 33.
FIGS. 35 and 35A are schematic views of the surgical site of FIG. 33 at a graft fixation stage subsequent to that shown in FIGS. 34 and 34A.



DETAILED DESCRIPTION
Referring to FIGS. 1-3, an interference screw 10 according to an embodiment of the present invention is shown. Screw 10 is preferably formed of a bioabsorbable material such as PLLA and has a cannulated body 12 provided with a continuous thread 16 having rounded outer edges 18. The head 14 of the screw is rounded to minimize abrasion or cutting of tissue, and the screw tapers toward the distal end. A hexagonal bore 15 formed through the screw accepts a driver shaft described in more detail below.
FIGS. 4-6 illustrate an interference plug 20 according to an alternative embodiment of the present invention. Plug 20 is also preferably formed of a bioabsorbable material and has a cannulated body 22 provided with rounded annular ribs 24 separated by rounded annular grooves 26. The outer diameter of the ribs and grooves is substantially constant. The plug tapers significantly toward the distal end. Cannula 28 is preferably round in cross-section but may also be hexagonal or any other shape, and is designed to accommodate the shaft of a corresponding driver.
FIG. 7 illustrates a driver 30 according to an embodiment of the present invention for driving the interference screw described above. Generally, driver 30 includes a handle 32, inner shaft 34, and outer shaft 36. FIG. 8 shows a handle having a connector 31 for coupling with driver 30.
FIG. 9 shows the inner shaft of driver 30. Inner shaft 34 has a cannula extending through its entire length and has openings at the proximal and distal ends to enable sutures to be passed therethrough. Inner shaft 34 includes a shaft body 38 having a threaded proximal section 39 and a hex-shaped distal section 35 for being fitted through the cannula 15 in interference screw 10. The diameter of the shaft body 38 is reduced slightly along the hex section 35, forming a shoulder 37 at the junction between the hex section 35 and the central portion of shaft body 38 for abutting the proximal end of an interference screw loaded onto the driver. Shaft 34 can be permanently affixed to the handle 32 as shown in FIG. 7, or can be releasably attached, as shown in the embodiment represented in FIGS. 8 and 9, by means of a collet 33 at the proximal end of the threaded section 39 being fittable within a connector 31 at the distal end of handle 32.
FIG. 10 shows the outer shaft 36 of the driver 30. Outer shaft 36 includes a sleeve 40 which covers and is slidable over shaft body 38, and a thumb pad 41 for being gripped by a user. Outer shaft 36 is cannulated through its entire length, of course, with the diameter of the cannula being slightly larger than the outer diameter of the central portion of inner shaft body 38. The portion of the cannula through thumb pad 41 is threaded to mate with the threads on the threaded proximal section 39 on inner shaft 34. The inner diameter of the inner threads in thumb pad 41 is smaller than the outer diameter of the central portion of shaft body 38, so as to limit the proximal movement of the outer shaft 36 relative to the inner shaft 34.
The proximal threaded section 39 on the inner shaft 34 has a length such that when the outer shaft 36 is unscrewed to its proximal-most position with the thumbpad adjacent the distal end of handle 32 or connector 31, shoulder 37 on the inner shaft 34 is flush with or exposed through the distal end of sleeve 40 of outer shaft 36.
The length of hex section 35 is such that when a cannulated interference screw is loaded onto the driver with the proximal end of the screw abutting the shoulder 37, the hex driver portion exposed distally of the mounted screw can reach the bottom of a socket created in the bone where the screw will be inserted, while the screw is positioned just outside the hole. Thus, the hex section 35 has a length which is approximately twice the length of the interference screw usable with the driver. Similarly, the length of the threaded proximal section 39 is also approximately equal to the length of the screw.
An alternative embodiment of the driver for the interference screw is shown in FIG. 11. In this embodiment, the outer shaft is eliminated so that the driver 30′ is comprised of a single cannulated shaft. The shaft body 38′ has an enlarged outer diameter relative to that of the previous embodiment, and tapers down to hex section 35′ via a tapered section 37′. When loading a screw onto the driver 30′, the proper initial position of the screw is established by inserting the hex section through the cannula of the screw until the travel of the proximal end of the screw 10 is limited by the increased diameter in tapered section 37′. As before, the hex section has a length which enables the distal end of the hex section to be inserted to the bottom of the socket while positioning an interference screw loaded onto the driver just outside the socket with the bottom thread of the screw able to engage the opening of the hole upon the application of a small amount of force into the hole.
FIGS. 12A and 12B illustrate an example of a driver usable with an interference plug in accordance with an embodiment of the present invention, in which the plug is driven into the socket by impaction rather than being screwed into place. Driver 50 comprises essentially of an outer shaft 52 and a cannulated inner shaft 54. Inner shaft 54 is inserted into the cannula 51 of outer shaft 52 and has a proximal portion 55 which has an outer diameter slightly smaller than the diameter of cannula 51 to enable the outer shaft 52 to slide along proximal portion 55. Inner shaft 54 also has a distal portion 57 which has a diameter smaller than that of proximal portion 55 and sized for insertion into the cannula 28 of interference plug 20. The cross-sectional shape of distal portion 57, and hence of cannula 28 of plug 20, is preferably round, but can also be hex or any other shape, as long as the distal portion 57 of inner shaft 54 is matingly shaped with the distal portion 57 of driver 50 to be insertable into cannula 28 of plug 20. The junction between proximal portion 55 and distal portion 57 forms shoulder 56 for abutting the proximal end of the plug when the plug is loaded onto the driver 50.
The length of outer shaft 52 is equal to the length of proximal portion 55 of inner shaft 54 plus a distance “a” equal to the length of the interference plug usable therewith. The length of distal section 57 is approximately equal to twice the length of a plug 20, and shoulder 56 on the inner shaft 54 is flush with or just exposed through the distal end of outer shaft 52 when outer shaft 52 is in its fully retracted (proximal) position.
A method of performing soft tissue fixation in accordance with an embodiment of the present invention will now be described with reference to FIGS. 14-19.
As shown in FIG. 14, sutures 62 are passed through the graft 60 at desired points, and a blind hole or socket 66 is created in the bone 64, using a drill or punch, at the location where the tissue is to be secured. A punch provides the advantages of rounding the opening edge of the bone socket to protect the sutures attached to the graft from being sheared during the insertion process, and also compacts the bone at the punch site for better purchase of the bone by the anchor in cases where the bone is a soft bone. An example of such a punch is illustrated in FIG. 13, the punch having a constant diameter section 72, a tip 74, a flared section 76, and a main body portion 78. The diameter of the constant diameter section corresponds to the diameter of the driver.
Next, as shown in FIG. 15, driver 30 is pre-loaded with screw 10 with outer shaft 36 in the fully retracted position and the distal end of the screw abutting shoulder 37 of inner shaft 34 and the distal end surface of outer shaft 36. Traction suture 68 is passed into the cannula of the driver, such that a looped end 70 is exposed at the distal end of the driver. Sutures 62 attached to graft 60 are then passed through traction suture loop 70 at the end of driver 30 as seen in FIG. 16, to position the graft at an appropriate distance from the distal end of driver 30, either at a distance corresponding to the length of the screw or so that the graft is located directly at the distal end of the driver.
Referring now to FIG. 17, the driver 30 is held with gentle pressure with the distal end of hex section 35 at the bottom of the hole 66, keeping the screw 10 just outside the hole. Tension can then be placed on the graft sutures 62 by drawing on traction suture 68 to tighten suture loop 70. Once adequate tension is achieved on the sutures, the driver is manipulated so that the first thread edge of the screw engages the bone at the edge of the hole 66. The driver is turned by rotating handle 32 and thus inner shaft 34 while preventing outer shaft 36 from rotating by holding thumb pad 41 in place during rotation of handle 32. This maneuver causes the outer shaft to move distally along the inner shaft by the interaction of the inner threads in the outer shaft 62 with the threads on threaded portion 39 of inner shaft 34, while also causing the screw threads to engage the sides of the hole and pull the screw into the hole. The inner shaft of the driver thus rotates without advancing further into the hole, while the outer shaft guides the insertion of the screw into the socket. In this manner, the screw advances along the hex section of the driver until the screw is fully installed to the position shown in FIGS. 18A and 18B, with sutures 62 or the graft 60 pinned and/or wound between the base and sidewall of socket 66 and interference screw 10. Optionally, sutures 62 may be twisted together at the time they are passed through loop 70 to increase contact with the screw upon insertion of the screw into the socket.
After the screw is fully inserted, traction loop 70 is disengaged from the handle, and the driver is removed. As seen in FIG. 19, the ends of the sutures can be removed by clipping them short, leaving the graft securely fastened in place to the bone.
A procedure similar to that just described is performed with respect to the installation of an interference plug, except that a driver such as driver 50 shown in FIGS. 12A and 12B is used instead of driver 30 of FIGS. 7-10, and the plug is advanced into the hole using impact force supplied by a mallet, for example, rather than by turning. When the proximal end of outer shaft 52 is hit with the mallet, the proximal end of plug 20 abutting against shoulder 56 on the inner shaft 54 and the distal surface of outer shaft 52 pushes the plug into the socket 66. In this method, the plug is fully inserted into the hole when the proximal end of outer shaft 52 is flush with the proximal end of inner shaft 54.
In a first alternative to the method described above, sutures 62 attached to the graft 60 are eliminated, so that in the step shown in FIG. 16, the graft itself is passed through the suture loop 70 to be secured from the bottom of the hole 66 by the tip of plug 20.
In an alternative to the method described above, traction suture 68 and loop 70 are eliminated, so that in the step shown in FIG. 16, instead of passing sutures 62 through loop 70, the ends of sutures 62 are threaded into the cannula of the inner shaft 34 through the distal end thereof, through the length of driver 30 or 50, and out the opening at the proximal end thereof, as illustrated in FIG. 20.
FIGS. 21 and 22 illustrate an implant driver 100 of another embodiment of the present invention. Driver 100 includes a body 104, preferably in the form of a cylinder, and having a distal end 112 (FIG. 21) and a proximal end 113 (FIG. 22). The body 104 of driver 100 includes an outer shaft 117 and an inner shaft 119. The outer shaft 117 is cannulated for receiving inner shaft 119.
As illustrated in FIG. 21, driver 100 is pre-loaded with an interference device 120. Preferably, the interference device 120 is a screw or an interference plug, preferably formed of a bioabsorbable material such as PLLA. If a screw is employed, the screw may be provided with a cannulated body provided with a continuous thread having rounded outer edges. The head of the screw may be rounded to minimize abrasion or cutting of tissue. The cannulation formed through the screw is preferably hex-shaped and accepts the correspondingly shaped inner shaft 119 of driver 100. If an interference plug is desired, the plug is provided with rounded annular ribs separated by rounded annular grooves. The outer diameter of the ribs and grooves is substantially constant. The plug tapers significantly toward the distal end. The plug also comprises a cannula, preferably hex-shaped, for accommodating the inner correspondingly shaped shaft 119 of the corresponding driver 100.
As also shown in FIG. 21, an eyelet implant 150 is provided at the distal end 112 of driver 100. The eyelet implant 150 is releasably attached to the distal end 112 of driver 100 by means of a connector 157. The eyelet implant 150 is formed of a transparent polymer material, and is preferably made of a bioabsorbable material such as PLLA, polyglycolic or polylactic acid polymers. Advantageously, the eyelet implant 150 is made of a material similar to that of the interference device 120. As illustrated in FIG. 21, the eyelet implant 150 is provided with aperture 155 for receiving a suture attached to a graft to pass through the eyelet implant 150, as described in more detail below. The width “w” (FIG. 21) of the eyelet implant 150 is about equal the diameter of the inner shaft 119 and slightly smaller than the diameter of the outer shaft 117 and of the cannula of the interference device 120.
FIG. 22 illustrates proximal end 113 of driver 100, showing a handle 115 disposed coaxially with the body 104 and outer shaft 117 and provided with handle slots or protuberances 116. As described below, handle slots or protuberances 116 allow a suture strand to be wrapped around the handle 115 and be subsequently tensioned prior to the impaction of the interference device 120 into the pilot hole. In this manner, the graft is precisely positioned at an appropriate distance from the pilot hole, and the suture with the attached graft is secured at the bottom of the pilot hole and prevented from exiting the pilot hole.
A method of a graft fixation technique according to an embodiment of the present invention is now described with reference to FIGS. 23-28. The present invention may be used to secure any type of soft tissue, graft, or tendon, such as, for example, a biceps tendon or a rotator cuff. FIG. 23 illustrates at least one suture 180 passed though the graft 170 at desired points. FIG. 23 also illustrates a pilot hole or socket 190 formed in the bone or cartilage 193 using a drill or punch, at the location where the tissue is to be secured. A punch provides the advantages of rounding the opening edge of the bone socket to protect the sutures 180 attached to the graft 170 from being sheared during the insertion process, and also compacts the bone at the punch site for better attachment of the bone by the anchor in cases where the bone is a soft bone.
Next, as shown in FIG. 24, driver 100 with a pre-loaded interference device 120 and with the outer shaft 117 in the retracted position is provided in the proximity of the bone socket 190. Sutures 180 attached to the graft 170 are subsequently passed through the aperture 155 of the eyelet implant 150 at the end of driver 100, as shown in FIG. 24.
Referring now to FIG. 25, driver 100 is held with gentle pressure so that the eyelet implant 150 at the distal end 112 is held at the bottom of the hole 190, keeping the interference device 120 just outside the pilot hole 190. Tension is then applied to the suture 180 by wrapping the suture 180 around the slots 116 of the handle 115 and tensioning it, as shown in FIGS. 26-27. The suture 180 freely slides through aperture 155 of the eyelet implant 150, allowing the graft 170 to be positioned close to the edge of the pilot hole 190. Once tensioning of the suture 180 has been completed, the interference device 120 is then impacted into the pilot hole 190 so that the interference device 120 advances toward the distal end 112 of driver 100 and securely engages and locks in the eyelet implant 150 with the sutures 180, as shown in FIGS. 27-28. After the interference device 120 is fully inserted, the driver is removed and the ends of the sutures can be removed by clipping them short, leaving the graft 170 securely fastened to bone 193.
A significant advantage of the present invention is that the sutures attached to the graft or the graft itself can be securely attached to the bone without the need to tie knots. Additionally, the suture attached to the graft is secured both by the eyelet implant and by the interference device, along the bottom and sidewalls of the pilot hole between the bone and the screw or plug, conferring a much stronger fixation of the graft to the bone than is achievable with prior art procedures and devices. More importantly, the suture attached to the graft is allowed to freely slide though the aperture of the eyelet implant to allow precise advancement and guiding of the plug or screw into the blind hole or socket during the procedure.
In another embodiment of the present invention illustrated in FIG. 29, driver 200 is provided with a horseshoe-shaped implant 250 (i.e., an implant with an open distal end) at the distal end of the driver in lieu of the eyelet implant. The horseshoe-shaped implant 250 is provided in the form of a wedge 255 that allows the suture attached to a graft to be securely contained within the wedge, yet be capable to freely slide within the wedge. The horseshoe-shaped implant 250 is formed of a transparent polymer material, and is preferably made of a bioabsorbable material such as PLLA, polyglycolic or polylactic acid polymers. Advantageously, the horseshoe-shaped implant 250 is made of a material similar to that of the interference device 20.
The horseshoe-shaped implant 250 may be detachable from the distal end 112 of the driver 200, similar to the eyelet implant described in detail above. In this embodiment, the detachable horseshoe-shaped implant 250 is securely engaged within the cannulated ribbed body of the interference plug or screw 120. Alternatively, the horseshoe-shaped implant 250 may be integral with the distal end 112 of the driver 200 and, after the interference screw or plug 120 is fully inserted into the pilot hole, the horseshoe-shaped implant 250 is removed from the site together with the driver 200.
In yet another embodiment of the present invention and as illustrated in FIG. 30, driver 300 of the present invention is provided with a metal tubing 350 at the distal end of a driver, which in turn, is provided with a cut or pair of protuberances 355 at its most distal end to allow at least one end of a suture attached to a graft to be securely contained within the cut, yet be capable to freely slide within the cut. Preferably, the metal tubing 350 is integral with the distal end 112 of the driver 300 and, subsequent to the full insertion of the interference screw or plug 120 into the pilot hole, the metal tubing 350 is removed from the site together with the driver 300.
FIGS. 31-35 illustrate another embodiment of the present invention, according to which driver 400 is provided with a pointed tip implant 450 at the distal end of the driver, which is also an eyelet implant but which, because of its pointed tip, does not require the pre-drilling or pre-formation of a hole for fixating the device (implant with suture attached to graft) in the bone. The conical configuration of the most distal end of the pointed tip implant 450 allows the driver 400 with the attached implant to undergo a self-punching operation during graft fixation, eliminating any need to pre-drill a hole in the bone and providing increased fixation of the overall operation of securing the soft tissue. The conical configuration of the most distal end of the pointed tip implant 450 also provides suture fixation strength, as well as accelerated graft/tendon healing to bone. The pointed tip implant 450 may be detachable from the driver.
As illustrated in FIGS. 31 and 32, pointed tip implant 450 is provided with an eyelet or aperture 455 for receiving at least one strand (for example, a suture strand) attached to a graft to pass through the eyelet implant 450. Pointed tip implant 450 is also provided, at its most distal end, with a conical portion 451 which allows direct advancement of the implant (by simply tapping the device with a mallet, for example) without the formation of a bone hole. Preferably, the conical portion 451 of the implant is formed of titanium or titanium alloy. In a preferred embodiment, eyelet or aperture 455 is also formed of titanium or similar material, to withstand impaction forces during the graft fixation procedure.
As in one of the previously-described embodiments, strand 180 (attached to graft 170) is passed through the aperture 455 of the implant 450 at the end of the driver 400, as shown in FIGS. 31 and 32. Although FIG. 32 illustrate two strands 80 (i.e., two suture strands 180) passed through the aperture 455, the invention is not limited to this exemplary embodiment and contemplates additional embodiments wherein one strand or any number of strands are passed through the aperture 455. Preferably, at least one of the strands is formed of a high strength suture material such as FIBREWIRE® suture, sold by Arthrex, Inc. of Naples, Fla., and described in U.S. Pat. No. 6,716,234, the disclosure of which is incorporated by reference herein. The high strength suture may be available in various lengths and widths. FIBREWIRE® suture is formed of an advanced, high-strength fiber material, namely ultrahigh molecular weight polyethylene (UHMWPE), sold under the tradenames SPECTRA (Honeywell) and DYNEEMA (DSM), braided with at least one other fiber, natural or synthetic, to form lengths of suture material. The preferred FIBREWIRE® suture includes a core within a hollow braided construct, the core being a twisted yarn of UHMWPE. The suture may optionally include filaments of various colors.
An example method of graft fixation using the pointed tip implant 450 is illustrated with reference to FIGS. 33-35. This exemplary method illustrated in FIGS. 33-35 relates to a specific graft fixation technique (i.e., SUTUREBRIDGE® Lateral Row fixation); however, the invention is not limited to this exemplary embodiment and applies to any other method of soft tissue fixation known in the art.
Referring to FIG. 33, an Arthrex SUTUREBRIDGE® medial row is completed as known in the art and the strands 180 (suture strands 180) are threaded through the titanium eyelet 455. As shown in FIG. 34A, a protective cap 194 (or other device that prevents anchor deployment) is malleted to advance the PUSHLOCK® implant 450 until the anchor 420 contacts bone 193. The suture is then tensioned, as shown in FIG. 34. The protective cap 194 is subsequently removed (FIG. 35A) and the button 420 is malleted until a mark (for example, a predefined laser line) is flush with the bone (FIG. 35). The ribbed, spiked configuration of plug or button 420 facilitates the insertion of the device 400 into the bone by simply exerting force upon the device, without the need to drill or form a hole in the bone.
Although the above embodiments have been described including implants having an aperture of a predefined configuration (e.g., an eyelet or horseshoe configuration), it should be understood that the invention is not limited to these embodiments. Accordingly, the present invention also contemplates implants affixed to or detachable from a preloaded driver and having an aperture of any configuration or geometrical shape that captures suture and allows the captured suture to freely slide within the aperture until the suture is locked in place.
A significant advantage provided by the example methods is that the sutures attached to the graft or the graft itself can be securely attached to the bone without the need to tie knots.
Another advantage achieved by the example embodiments of present invention is that the suture attached to the graft or the graft is secured both along the bottom of the bone socket by the tip of the interference screw or plug, as well as along the sidewall of the socket between the bone and the screw or plug. This arrangement results in a much stronger fixation of the graft to the bone than is achievable with prior art suture anchor procedures.
Although particular embodiments are described above, many other variations and modifications and other uses will become apparent to those skilled in the art who have the benefit of this description. For example, the various features of the example embodiments are not necessarily limited to the particular embodiments shown in the drawings. One or more features of an embodiment may be combined with one or more features of another to realize a different embodiment. Additionally, entirely different embodiments having similar features may be realized. The present invention cannot be limited by the specific disclosure herein, but only by the appended claims.

## Claims

1. An assembly for securing soft tissue, the assembly comprising:
an inserter having a proximal end and distal end, the inserter including a handle near the proximal end, the inserter including a shaft between the handle and the distal end;
an anchor body near the distal end of the inserter, the anchor body having a proximal edge received against a distal edge of the shaft;
a suture including a portion establishing a suture loop near the distal end, the suture loop being distal of the anchor body, the suture including a portion within the shaft, the suture having two ends that protrude outside of the inserter near the proximal end; and
a rotatable member near the handle and wherein rotational movement of at least one of the handle or the rotatable member causes a change in position of the anchor body relative to the suture loop.

2. The assembly of claim 1, wherein the the rotational movement causes relative movement between the anchor body and the suture loop.

3. The assembly of claim 2, wherein the relative movement comprises movement of the anchor body in a distal direction toward the suture loop.

4. The assembly of claim 2, wherein the rotational movement causes movement of at least a portion of the anchor body relative the suture loop.

5. The assembly of claim 4, wherein the rotational movement causes movement of the entire anchor body relative to the suture loop.

6. The assembly of claim 1, wherein the suture is removable from the inserter.

7. The assembly of claim 1, wherein the anchor body has an exterior that is configured to trap soft tissue between the exterior and bone.

8. The assembly of claim 1, wherein the ends of the suture protrude from the handle.

9. The assembly of claim 1, wherein
the shaft comprises an outer shaft; and
the anchor body proximal edge is received against a distal end of the outer shaft.

10. The assembly of claim 9, wherein the outer shaft is moveable relative to another portion of the inserter for moving the anchor body relative to the suture loop.

11. The assembly of claim 1, wherein the ends of the suture protruding outside of the inserter are configured to be manipulated to change at least one of a size of the suture loop or a position of the loop relative to the distal end of the inserter.

12. The assembly of claim 1, wherein a size of the loop can be changed by manipulating at least one of the ends of the suture from outside the inserter.

13. The assembly of claim 1, wherein the anchor body comprises a threaded screw.

14. The assembly of claim 1, wherein the anchor body comprises a plug.

15. The assembly of claim 1, wherein
the assembly has a first condition including the anchor body in a first position relative to the suture loop;
the first condition includes the suture loop being configured to gather soft tissue near the distal end;
relative movement between the suture loop and the anchor body establishes a second condition of the assembly;
the second condition includes the anchor body being in a second position relative to the suture loop where the anchor body is situated for securing soft tissue to bone; and
the second condition includes the soft tissue captured within the suture loop.

16. The assembly of claim 15, wherein
the first condition includes the anchor body outside of the bone; and
the second condition includes the suture loop and the anchor body inside the bone.

17. A tissue securing assembly, comprising:
an inserter including a distal end and a proximal end, the inserter including a handle near the proximal end, the inserter having a longitudinal axis between the distal end and the proximal end, the inserter including a shaft along the longitudinal axis;
an anchor body near the distal end, the anchor body being configured to be received in a hole in bone for trapping at least a portion of soft tissue in bone, the anchor body having a proximal edge that is received against a distal edge of the shaft;
a tissue gathering portion near the distal end, the tissue gathering portion being distal of the anchor body, the tissue gathering portion being configured to at least temporarily gather a portion of soft tissue near the distal end of the inserter for moving the portion of soft tissue with the distal end of the inserter into a hole in bone;
a second portion coupled to the tissue gathering portion, the second portion extending along the longitudinal axis from the tissue gathering portion to near the proximal end, the second portion being at least partially within the inserter and at least partially protruding outside of the inserter, the second portion being at least partially within the shaft, the second portion being moveable relative to the handle to change a position of the tissue gathering portion relative to the anchor body; and
a rotatable member near the handle and wherein rotational movement of at least one of the handle or the rotatable member causes a change in position of the anchor body relative to the tissue gathering portion.

18. The assembly of claim 17, comprising a suture and wherein
the tissue gathering portion is a portion of the suture that establishes a suture loop near the distal end; and
the second portion is another portion of the suture between the suture loop and ends of the suture.

19. The assembly of claim 18, wherein the suture is removable from the inserter.

20. The assembly of claim 17, wherein the rotational movement of at least one of the handle or the rotatable member causes movement of the anchor body in a distal direction.

21. The assembly of claim 17, wherein some of the second portion at least partially protruding outside of the inserter is configured to be manipulated to change at least one of a size of the tissue gathering portion or a position of the tissue gathering portion relative to the distal end of the inserter.

22. The assembly of claim 21, wherein
the tissue gathering portion and the second portion are sections of a suture;
the tissue gathering portion comprises a loop formed by one of the sections of the suture;
the second portion includes ends of the suture; and
a size of the loop can be changed by manipulating at least one of the ends of the suture from outside the inserter.

23. The assembly of claim 17, wherein the anchor body comprises a threaded screw.

24. The assembly of claim 17, wherein the anchor body comprises a plug.

25. The assembly of claim 17, wherein
the assembly has a first condition including the anchor body in a first position relative to the tissue gathering portion;
the first condition includes the tissue gathering portion being configured to gather soft tissue near the distal end;
relative movement between the tissue gathering portion and the anchor body establishes a second condition of the assembly;
the second condition includes the anchor body being in a second position relative to the tissue gathering portion where the anchor body is situated for securing soft tissue to bone; and the second condition includes the soft tissue captured within the tissue gathering portion.

26. The assembly of claim 25, wherein
the first condition includes the anchor body outside of the bone; and
the second condition includes the tissue gathering portion and the anchor body inside the bone.