AU2018264007A1 - Arthroscopic implants with integral fixation devices and method for use - Google Patents

Abstract

An implant useful for reconstructing a knee that has sustained a rupture or tear of an anterior cruciate ligament. The implant has first and second opposed member connected by a replacement graft. The members may have external screw threads. In addition there is a method of reconstructing a knee using the implant of the present invention, wherein the knee has sustained an anterior cruciate ligament injury.

Description

ARTHROSCOPIC IMPLANTS WITH INTEGRAL FIXATION DEVICES AND METHOD FOR USE

FIELD OF THE INVENTION [0001] This invention relates to implants for arthroscopic surgical procedures, in particular to implants and associated procedures for replacing an anterior cruciate ligament in the knee.

BACKGROUND OF THE INVENTION [0002] Arthroscopic surgical repairs of a ruptured anterior cruciate ligament in the knee are known in this art. A rupture of the anterior cruciate ligament (“ACL”) is often seen in sports related injuries. In a conventional arthroscopic ACL reconstruction procedure, the surgeon prepares the patient for surgery by insufflating the patient’s knee with sterile saline solution. Several cannulas are inserted into the knee and used as entry portals into the interior of the knee. A conventional arthroscope is inserted through one of the cannulas so that the surgeon may view the surgical site remotely. The surgeon then drills a tibial tunnel and a femoral tunnel in accordance with conventional surgical techniques using conventional surgical drills and drill guides. A replacement anterior cruciate ligament graft is then prepared and mounted in the tibial and femoral tunnels, and secured using conventional techniques and known fixation devices in order to complete the knee reconstruction.

[0003] Several types of anterior cruciate ligament grafts are available for use by the surgeon in ACL reconstruction. The grafts may be autografts that are harvested from the patient, for example, patellar bone-tendon-bone grafts, or hamstring grafts. Alternatively, the grafts can be xenografts, allografts, or may be prepared using natural or synthetic polymers. There are various known methods of securing these ACL grafts in bone tunnels. These methods include the use of fixation devices such as one or more cross-pin intersecting the tunnel to retain the graft, interference screws driven between the graft and a wall of the bone tunnel, or any of various other retention devices applied during surgery for positioning, tensioning and securing the graft.

2018264007 13 Nov 2018 [0004] Although the existing methods for performing ACL reconstruction are satisfactory for their intended purpose, and generally provide the patient with the desired therapeutic result, these surgical procedures are considered by some to be complex and generally leave one or more implants, such as cross pins or interference screws, in the patient. In certain cases it is believed that implants may trigger immune responses in the patient, or otherwise interfere with healing, for example, by reducing the area of direct contact between the ACL graft tendon and the patient’s native tissue. It would thus be desirable to reduce or eliminated the use of fixation devices in ACL surgery, and particularly the use of fixation devices remaining in the patient after surgery.

[0005] Accordingly, there is a need in this art for improved devices and methods of

ACL reconstruction having reduced complexity and reduced dependence on fixation devices that behave post-surgically as foreign bodies in the patient.

SUMMARY OF THE INVENTION [0006] The present invention relates to arthroscopic procedures and implants, and particularly to implants and procedures for replacing an anterior cruciate ligament in the knee. It is an object of the present invention to provide a surgical implant that includes one or more integrated fixation device for deployment in a bone tunnel during arthroscopic surgery such as ACL repair surgery, thereby reducing or eliminating the requirement for additional fixation devices to position and retain the implant.

[0007] It is a further object of the present invention to provide an integrated implant for arthroscopic surgery that can be implanted and tensioned using a single installation tool.

[0008] It is yet a further object of the present invention to provide improved ACL replacement surgical procedures having reduced procedural complexity and a reduction in the number foreign bodies remaining in the body after surgery.

[0009] Accordingly, an implant is disclosed for replacing an anterior cruciate ligament in a knee. The implant includes a first fixation member having an axis and a first substantially cylindrical external surface about the axis. The first surface defines first

2018264007 13 Nov 2018 external screw threads adapted for threaded engagement with first internal screw threads formed in a tunnel in a tibia adjacent to the knee. The first external screw threads have a first major thread diameter and a first minor thread diameter. The implant also includes a second fixation member having a second substantially cylindrical external surface about the axis. The second surface defines second external screw threads adapted for threaded engagement with second internal screw threads formed in a tunnel in a femur adjacent to the knee. The second external screw threads have a second major thread diameter and a second minor thread diameter. The implant also includes a flexible graft ligament member interconnecting the first fixation member and the second fixation member.

[0010] In one embodiment, the first fixation member, the second fixation member and the ligament member are made using allograft tissue. In another embodiment, the first fixation member, the second fixation member and the ligament member are made using xenograft tissue. In a further embodiment, at least one of the first and the second fixation member is reinforced with a biocompatible material. In another embodiment, the first and the second fixation member and the ligament member are manufactured using synthetic biocompatible material.

[0011] In different embodiments, the second major thread diameter is equal to the first thread diameter, or the second major thread diameter is smaller than the first minor thread diameter. In an embodiment where the second major thread diameter is smaller than the first minor thread diameter, the second fixation member can be passed through the tunnel in the tibia without engaging the internal screw threads therein [0012] The implant may also include an axial bore through the first fixation member and at least partially through the second fixation member. In different embodiments, the axial bore has a polygonal or an oval internal cross section. The axial bore is adapted for sliding engagement with an insertion tool for the implant, the tool including a proximal handle and a distal shaft fixed to the handle and adapted for sliding engagement with the axial bore. When the implant is mounted on the tool, the handle is positioned outside the axial bore. Either or both of the first and the second fixation member may also include one or more transverse bore in fluid communication with the axial bore and with the respective external surface. The one or more transverse bore can

2018264007 13 Nov 2018 be used to deliver a fluid to a surgical site. For delivering the fluid to the surgical site, the tool may include a cannulation through the handle and at least partially through the shaft.

[0013] Another aspect of the present invention is a kit including the tool and the implant, where the implant includes the axial bore. The kit may include an implant with the second major thread diameter equal to the first major thread diameter, or may include the implant with the second major thread diameter smaller than the first minor thread diameter. The implant in the kit may also include the one or more transverse bore and the cannulated tool.

[0014] Yet another aspect of the present invention is an implant that includes tissue harvested from a mammal. The tissue includes a ligament member having a first end and a second end. A first bone block is attached substantially at the first end and a second bone block is attached substantially at the second end. External screw threads are present on at least one of the first and the second bone block. These external threads are adapted for threaded engagement with internal screw threads formed in a tunnel in a bone of a living patient.

[0015] Still another aspect of the present invention is an implant that includes a graft ligament having a first end and a second end. A first bone block is attached to the graft ligament substantially at the first end. The first bone block is adapted to fit within a tunnel in a bone, the tunnel having a wall. A second bone block is attached to the graft ligament substantially at the second end. The first bone block includes an edge adapted to wedge against the wall of the tunnel in response to tension applied to the graft ligament by pulling on the second bone block.

[0016] Yet another aspect of the present invention is a method for replacing an anterior cruciate ligament in a knee. The method includes steps of forming an internally screw threaded first tunnel through a tibia adjacent to the knee, and forming an internally screw threaded second tunnel in a femur adjacent to the knee. The method also includes providing a threaded implant as described herein, the implant having an axial bore for receiving an insertion tool, and providing the insertion tool including a handle fixed to an

2018264007 13 Nov 2018 elongated shaft adapted for sliding engagement with the axial bore through the first fixation member and at least partially through the second fixation member.

[0017] The method further includes slidingly engaging the tool with the first and the second fixation member, passing the second fixation member through the internally threaded first tunnel, and simultaneously rotationally threading the first fixation member into the internally threaded first tunnel and the second fixation member into the internally threaded second tunnel. In one embodiment, the second fixation member is passed through the internally threaded first tunnel by engaging the second external threads in the internally threaded first tunnel and rotationally threading the second fixation member through the internally threaded first tunnel. In another embodiment, the second major thread diameter is smaller than the first minor thread diameter, and the second fixation member is passed axially through the first tunnel without screw thread engagement.

[0018] The method may also include steps of disengaging the tool from the second fixation member while leaving the tool engaged with the first fixation member, tensioning the implant by rotating the tool and the first fixation member engaged therewith, then disengaging the tool from the first fixation member. In another embodiment, the method includes injecting a fluid through the implant, wherein the implant defines at least one transverse bore in fluid communication with the axial bore and at least one of the first and the second external surface, the tool further including a cannulation in fluid communication with the at least at least one transverse bore. In various embodiments, the fluid is an adhesive, a medicant, or a lubricant.

[0019] Still another aspect of the present is a method for repairing a knee of a patient. The method includes the steps of preparing a tibial tunnel in a tibia adjacent to the knee and preparing a femoral tunnel in a femur adjacent to the knee. The method also includes the step of providing an implant including a graft ligament having a first end and a second end, a first bone block attached to the first end and a second bone block attached to the second end, each of the first and the second bone block including an integral fixation device for fixation in a bone tunnel. The method also includes steps of fixating the first bone block in the femoral tunnel using the first fixation device; and fixating the second bone block in the tibial tunnel using the second fixation device.

2018264007 13 Nov 2018 [0020] These and other aspects of the present invention will be more apparent from the following description and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS [0021] FIG. 1 illustrates an embodiment of an implant of the present invention including a ligament graft with an integral externally threaded fixation members at proximal and distal ends, the fixation members being of substantially equal diameter; the implant is shown in a knee..

[0022] FIG. 2 illustrates a proximal end view of an embodiment of the implant of

FIG. 1, the implant including a polygonal cross section longitudinal bore for receiving an insertion tool.

[0023] FIG. 3 illustrates an end view of another embodiment of the implant of FIG.

1, the implant including an oval cross section longitudinal bore for receiving an insertion tool.

[0024] FIG. 4 illustrates an embodiment of an implant of the present invention including a ligament graft with fully circumferentially threaded fixation members at proximal and distal ends.

[0025] FIG. 5 illustrates an embodiment of an implant of the present invention including a ligament graft with externally threaded fixation members at proximal and distal end ends, the fixation members being of unequal diameter.

[0026] FIG. 6 illustrates an embodiment of an implant of the present invention including a ligament graft having externally threaded fixation members at proximal and distal ends, at least one of the fixation members including fluid injection ports.

[0027] FIG. 7 illustrates an embodiment of an implant of the present invention including a ligament graft having a toggle-type fixation member connected at one end.

2018264007 13 Nov 2018 [0028] FIG. 8 illustrates an embodiment of a polygonal external cross section insertion tool for a threaded implant of the present invention having a mating, polygonal internal cross section longitudinal bore.

[0029] FIG. 9 illustrates an embodiment of a cannulated insertion tool for an implant of the present invention, for delivering a fluid to a surgical site.

[0030] FIG. 10 illustrates an embodiment of an oval external cross section insertion tool for an implant of the present invention having a mating oval internal cross section longitudinal bore.

[0031] FIG. 11 illustrates an embodiment of an insertion tool for a toggle-type implant of the present invention.

[0032] FIGs. 12 through 15 illustrate an embodiment of a procedure for mounting a threaded implant of the present invention in a joint.

[0033] FIGs. 16 and 17 illustrate an embodiment of a procedure for mounting a toggle-type implant of the present invention in a joint.

DETAILED DESCRIPTION OF THE INVENTION [0034] Referring more particularly to the figures, FIG. 1 illustrates an embodiment of a threaded implant 100 according to the present invention. The implant 100 has a distal end 102, a proximal end 104, and a longitudinal axis 106 extending therebetween. The implant 100 also includes a distal fixation member 108 for fixing the implant into a first internally threaded tunnel in bone 110, a proximal fixation member 112 for fixing the implant into a second internally threaded tunnel in bone 114 and an interconnecting flexible ligament member 116 extending between the distal fixation member 108 and the proximal fixation member 112. The implant 100 can be fashioned from harvested allograft or xenograft tissue suitable for a bone-tendon-bone implant, or manufactured from natural or synthetic materials including biocompatible polymers, ceramics, minerals, and combinations thereof. The flexible ligament member 116 may be integral with one or both of the distal 108 and the proximal fixation member 112, or the distal fixation member 108,

2018264007 13 Nov 2018 the proximal fixation member 112 and the flexible ligament member 116 may be separately harvested or manufactured components that are assembled to form the implant 100. In an embodiment, the implant 100 is a BTB allograft, and each of the distal 108 and the proximal fixation member 112 is formed from a harvested bone block at an end of the allograft.

[0035] The distal fixation member 108 is substantially cylindrical in shape and includes external screw threads 118 centered about the longitudinal axis 106 and having a major thread diameter 120, a minor thread diameter 122, and a longitudinal thread spacing 124. By major thread diameter of an external screw thread, we mean the outer diameter of an external screw thread measured at peaks of the threads. A major thread diameter of a threaded fixation member corresponds to an outer diameter of the fixation member. By minor thread diameter of an external screw thread, we mean the diameter of an external screw thread measured from the bottom of valleys between the threads. Longitudinal thread spacing (thread spacing) is the longitudinal distance between adjacent threads, and is inversely related to thread pitch, that is, thread pitch equals 1/thread spacing. Thread depth is the radial distance between the peaks and valleys of the thread, equal to half of the difference between the major thread diameter and the minor thread diameter.

[0036] The proximal fixation member 112 is substantially cylindrical in shape has external screw threads 126 of substantially the same screw thread specifications with regard to major diameter 120, minor diameter 122 and thread spacing 124 as the distal fixation member 108. Screw threads may be formed on the implant 100 by any thread forming method suitable for fabricating a surgical implant. Examples of suitable external thread-forming methods for the distal 108 and proximal fixation member 112 may include mechanical thread cutting, laser or water-jet cutting, and pressure forming. Preparation of the implant may also include reinforcing one or both bone blocks with a biocompatible material such as a bone cement, an apatite composition, or a curable polymeric material. The reinforcing material may be a bioreplaceable material or a nonabsorbable material or a combination thereof.

[0037] Fixation members of the present invention are sized similarly to bone blocks used in conventional ACL repair surgery, typically in the range of 15 millimeters to forty

2018264007 13 Nov 2018 millimeters in length, and eight millimeters to twenty millimeters in diameter. In one embodiment of the present invention, a major thread diameter of a fixation member is in the range of eight to twenty millimeters. In another embodiment, the major thread diameter is in the range of twelve to fifteen millimeters. In an embodiment, the thread pitch is in the range of six to twelve threads per inch and the thread depth is in the range of 0.04 inches to 0.125 inches.

[0038] The implant 100 also includes an axial bore 128 through the proximal fixation member 112 and at least partially through the distal fixation member 108. In the embodiment illustrated in FIG. 1, the axial bore 128 in the distal fixation member 108 is closed at the distal end 102. In another embodiment, the distal fixation member 108 is bored through to the distal end 102. The axial bore 128 is adapted for internal sliding, removable engagement with a tool for rotating the implant 100 about the axis 106, for threading the implant 100 through the second internally threaded tunnel 114 and into the first internally threaded tunnel 110. In an embodiment, the implant 100 is an ACL graft implant, the second internally threaded tunnel 114 is a bore in a tibia and the first internally threaded tunnel 110 is in a femur. In an embodiment, fixation of the implant 100 in a threaded bone tunnel requires as fixation means only the external threads 118, 126 fashioned from the material of respective bone blocks or their synthetic equivalents. That is, the fixation means for the implant 100 is unitary with the implant 100.

[0039] FIG. 2 illustrates a proximal end view 130 of an embodiment of the implant

100 of FIG. 1, wherein the axial bore 128 has a hexagonal cross section 132. The cross section of the bore 128 may also be another cross section, such as another polygonal cross section, adapted for sliding, removable engagement with an insertion tool having a corresponding external cross section. FIG. 3 illustrates a proximal end view 134 of another embodiment of the implant 100 of FIG. 1, wherein the bore 128 has an oval cross section 136 for sliding, removable engagement with an insertion tool having a corresponding oval external cross section. By an oval cross section, we mean any elongated cross section having rounded ends, for example, an ellipse or a flat-sided elongated shape with rounded ends.

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2018264007 13 Nov 2018 [0040] The external screw threads 118, 126 of the implant 100 are interrupted at a circumferential position 138 about the axis 106, corresponding to the orientation of the flexible ligament member 116 of the implant. The interruption of the threads 118, 126 is included to avoid damage to the ligament member 116 of the implant 100 when the threads 118, 126 are formed or when the implant 100 is threaded into the first 110 or the second internally threaded tunnel. FIG. 4 illustrates another embodiment of an implant 150 of the present invention that does not require circumferential interruption of external screw threads. The implant 150 includes a threaded distal fixation member 152, a threaded proximal fixation member 154, and a flexible ligament member 156 interconnecting the distal 152 and the proximal fixation member 154. Each of the distal 152 and proximal fixation member 154 has a major screw thread diameter 158 and a minor screw thread diameter 160. The flexible ligament member 152 is seen to be positioned completely within the minor thread diameter 160 of both the distal 152 and the proximal fixation member 154, thereby preventing damage to the flexible ligament member 156 when the implant 150 is threaded into mating internally threaded bone tunnels. The implant 150 is also seen to have a longitudinal axis 162 and an axial bore 164 through the proximal fixation member 154 and into the distal fixation member 152, for sliding, removable engagement with an insertion tool.

[0041] FIG. 5 illustrates an embodiment of a dual-diameter threaded implant 200 according to the present invention. The dual diameter implant 200 is constructed in a similar manner to the threaded implant 100 illustrated in FIG. 1, but the dual diameter implant 200 includes an externally threaded distal fixation member 202 that is smaller in diameter than an externally threaded proximal fixation member 204. The dual diameter implant also includes an interconnecting flexible ligament member 206 extending between the distal 202 and the proximal fixation member 204. The distal fixation member 204 has first screw threads 208 having a first major thread diameter 210, a first minor thread diameter 212 and a first longitudinal thread spacing 214. The first screw threads 208 are adapted to thread into a first internally threaded tunnel in bone 216. The proximal fixation member 204 has second screw threads 218 having a second major thread diameter 220, a second minor thread diameter 222 and a second longitudinal thread spacing 224. The second screw threads 218 are adapted to thread into a second internally threaded tunnel in bone 226.

2018264007 13 Nov 2018 [0042] In an embodiment, the first major thread diameter 210 is less than or equal to the second minor thread diameter 222. That is, the distal fixation device 202 is adapted to pass longitudinally and substantially without mechanical interference through the second internally threaded tunnel. Thus, the implant 200 can be passed distally directly through the second internally threaded tunnel 226 to the first internally threaded tunnel 216, and threaded substantially simultaneously into the first 216 and the second internally threaded tunnel 226. The second thread spacing 224 is substantially equal to the first thread spacing 214, so that the distal 202 and the proximal fixation device 204 can be threaded into their respective threaded tunnels at the same axial rate with rotation of a single insertion tool engaged through an axial bore 228 through the proximal fixation member 204 and into the distal fixation member 202.

[0043] FIG. 6 illustrates yet another embodiment of a threaded implant 250 of the present invention. The implant 250 includes a distal fixation member 252 having a first external surface 254, and a proximal fixation member 256 having a second external surface 258. A flexible ligament member 260 extends between and interconnects the distal 252 and the proximal fixation member 256. The implant 200 also includes an axis 262, and an axial bore 264 through the proximal fixation member 256 and into the distal fixation member 252. In an embodiment, the axial bore 264 extends distally completely through the distal fixation member 252. One or both of the distal 252 and the proximal fixation member 254 includes one or more transverse bore 266 providing fluid communication between the axial bore 264 and one or both of the first 254 and the second external surface 258, for delivering a fluid to a surgical site. The fluid may be an adhesive, a cement or filler material, a lubricant, a medicant such as pain medication or a healing stimulant, or another fluid. The fluid can be delivered by injection through a cannulated insertion tool positioned in the axial bore 264 and having transverse apertures aligned with the one or more transverse bore 266. In one embodiment, the fluid is an adhesive that enhances the fixation of a fixation member in a bone tunnel.

[0044] Another type of fixation member integrated with an implant of the present invention includes use of a toggling action to fix the implant in a bone tunnel. FIG. 7 illustrates a toggle-type implant 300 having a distal fixation member 302 for fixing in a first bone tunnel 304, a proximal fixation member 306 for fixing in a second bone tunnel

2018264007 13 Nov 2018

308, and an interconnecting flexible ligament member 310 extending between the distal fixation member 302 and the proximal fixation member 306. The implant 300 also includes a longitudinal bore 312 through the proximal fixation member 306 and into or through the distal fixation member 302. The longitudinal bore 312 may be an axial bore, or may be radially displaced from a longitudinal axis 314. In one embodiment, the bore 312 has a circular internal cross section. In another embodiment, the bore 312 has an internal cross section adapted for sliding, removable engagement with an external cross section of an insertion tool at one or more specific rotational angle about the axis 314.

[0045] The distal fixation member 302 includes a proximal-pointing edge 316 adapted to wedge against or dig into a wall 318 of the first bone tunnel 304 (toggling action) to fix the distal fixation member 302 in place after it is positioned in the first bone tunnel 304. In an embodiment, the distal fixation member 302 is fixed in place by applying proximally-directed tension to the flexible ligament member 310, to toggle the distal fixation member 302 in the first bone tunnel 304. In one embodiment, the proximal fixation member 306 is externally threaded and the second bone tunnel 308 is correspondingly internally threaded. In another embodiment, the proximal fixation member 306 is a conventional bone block fixed in place in the second bone tunnel 308 by inserting an interference screw 320 between the bone block and a wall 322 of the second bone tunnel 308, or by application of another fixation device. In yet another embodiment, the bore 312 through the proximal fixation member 306 is internally screw-threaded for engagement with an externally screw-threaded insertion tool, for applying tension to the flexible ligament member 310.

[0046] FIG. 8 through FIG. 11 illustrate insertion tools for embodiments of the implants illustrated in FIG. 1 through FIG. 7. FIG. 8 illustrates a hexagonal cross section insertion tool 350 for the implant 100 of FIG. 1 and FIG. 2. The insertion tool 350 has a proximal end 352 and a distal end 354. The insertion tool 350 includes a proximal screwdriver-like handle 356 and a distal, elongated hexagonal external cross section shaft 358 adapted for sliding, removable engagement with the hexagonal internal cross section bore 132 illustrated in the proximal end view 130 of an embodiment of the implant 100. The shaft 358 is fixedly attached to the handle 356. The tool 350 is engaged with the implant 100 by passing the shaft 358 through the axial bore 128 through the proximal

2018264007 13 Nov 2018 fixation member 112 and into the distal fixation member 108. With the tool 350 engaged in the axial bore 128 in both the proximal 112 and the distal fixation member 108, turning the handle 356 rotates both fixation members about the axis 106 simultaneously, for threading the implant 100 into a bone tunnel.

[0047] When the distal 108 and proximal fixation member 112 is fully threaded into its respective first 110 and second tunnel 114, as illustrated in FIG. 1, the tool 350 can be fully withdrawn from the bore 128, leaving the implant 100 fixed in place. Alternatively, the tool 350 can be partially withdrawn from the bore 128 to disengage the shaft 358 from the distal fixation member 108 while remaining engaged with the proximal fixation member 112. Rotating the handle 356 with the tool 350 in this partially withdrawn position adjusts tension on the flexible ligament member 116 by rotating the externally threaded proximal fixation member 112 in the internally threaded second tunnel 114, while leaving the distal fixation member 108 stationary. When the tension adjustment is complete, the tool 350 can be fully withdrawn from the implant, leaving the tensioned implant 100 in place.

[0048] A cannulated insertion tool can be used to deliver a fluid to an implant of the present invention and to an associated surgical site. FIG. 9 illustrates a cannulated insertion tool 360 constructed in a similar manner to the hexagonal cross section insertion tool 350 illustrated in FIG. 8, with the addition of a cannulation 362 through the handle 356 and the shaft 358. The cannulation 362 is open at the proximal end 352 and in various embodiments is open or closed at the distal end 354. The cannulated tool 360 also includes one or more transverse aperture 364 through which a fluid introduced into the cannulation 362 from the proximal end 352 can be ejected from the cannulated tool 360. In an embodiment, the one or more transverse aperture 364 is aligned with the one or more transverse bore 266 in the implant 250 illustrated in FIG. 6, for delivery of a fluid to a surgical site. In addition to a fluid, gels or powders may also be delivered through the tool 360.

[0049] FIG. 10 illustrates an oval cross section insertion tool 370 that is similar in construction to the hexagonal cross section tool 350 of FIG. 8, except that the oval cross section tool 370 includes an oval external cross section distal shaft 372 adapted to

2018264007 13 Nov 2018 removably engage the oval internal cross section bore 136 illustrated in FIG. 3, in the proximal end view 134 of an embodiment of the implant 100. FIG. 11 illustrates an insertion tool 380 for use with the toggle type implant 300 illustrated in FIG. 7. The insertion tool 380 has the proximal handle 356 and a distal shaft 382 for passing through the axial bore 312 in the proximal fixation member 306 and into the distal fixation member 302 of the toggle-type implant 300. The insertion tool 380 is seen to also include a distal tip 384 adapted to engage with the axial bore 312 in the distal fixation member 302 while allowing the distal fixation member 302 to toggle. In an embodiment, the distal tip 384 is a distally tapered cone. In an embodiment, the shaft 382 includes a grasping member 386 for applying proximal tension to the implant 300, for toggling the proximal fixation member 306 and for tensioning the flexible ligament member 310. In an embodiment, the grasping member includes external screw threads for engagement with internal screw threads in the bore 312 through the proximal fixation member 306.

[0050] The distal shaft 382 has an external cross section adapted for engagement with the axial bore 312 through the proximal fixation device 306. In one embodiment, the proximal fixation device 306 has external screw threads, the axial bore 312 through the proximal fixation device 306 has a hexagonal internal cross section, and the distal shaft 382 has a hexagonal external cross section releasably engageable with the axial bore 312. In another embodiment, the proximal fixation device 306 is unthreaded and the distal shaft 382 has a circular external cross section.

[0051] Any of the implants and tools of the present invention may be supplied to a surgeon as a kit for performing ACL surgery. Packaging the implant and the tool as a kit provides additional convenience for the surgeon and stable. In a kit, the implant may be pre-mounted on the tool to provide even greater convenience for the surgeon and a means for stably and protectively packaging the implant for shipment and storage.

[0052] Referring now to FIGS. 12-15, the use of threaded implants and associated installation tools of the present invention in a surgical procedure is illustrated. Implants of the present invention may be used in the surgical repair of any articulated joint in a body, and have particular application to ACL repair surgeries in the human knee. Referring first to FIG. 12, prior to the installation of a threaded implant 400 of the present invention in a

2018264007 13 Nov 2018 knee 402, the knee 402 is prepared and positioned for ACL replacement surgery using conventional surgical tools and conventional surgical procedures. The implant 400 includes an externally threaded distal fixation member 404 having first external screw threads 406, an externally threaded proximal fixation member 408 having second external screw threads 410, and a flexible ligament member 412 extending between and interconnecting the distal fixation member 404 and the proximal fixation member 408. The implant 400 also is seen to have an axial bore 414 for receiving an insertion tool 416. The insertion tool 416 includes a proximal handle 418 and a distal shaft 420 for engagement with the axial bore 414. The implant 400 is mounted on the tool 416 by passing the shaft 420 distally through the axial bore 414 in the proximal fixation member 408 and into the axial bore 414 in the distal fixation member 404. The handle 418 can be rotated to rotate the tool 416 and the implant 400 mounted thereon.

[0053] A tibial bone tunnel 422 through a tibia 424 and a femoral bone tunnel 426 in a femur 428 are prepared using conventional surgical tools and techniques. The tibial tunnel 422 and the femoral tunnel 426 share a common axis 430. The tibial tunnel 422 is prepared with an internal diameter and internal screw threads adapted to engage with the second screw threads 410 on the proximal fixation member 408. The femoral tunnel 426 is prepared with an internal diameter and internal screw threads adapted to engage with the first screw threads 406 on the distal fixation member 404. The internal screw threads of the tibial 422 and the femoral tunnel 426 are formed using conventional thread forming techniques and tools. In an embodiment, the internal screw threads in each of the tibial 422 and femoral tunnel 426 are prepared using a threading tap. In one embodiment, the implant 400 includes distal and proximal fixation members of equal diameter, as described herein in association with embodiments of the implant 100 illustrated in FIG. 1. In this embodiment, the tibial tunnel 422 and the femoral tunnel 426 are each prepared with internal threads of a single thread specification with regard to major and minor thread diameter, and with regard to thread pitch. In another embodiment, the implant 400 includes distal and proximal fixation members having unequal diameters, as described herein in association with embodiments of the implant 200 illustrated in FIG. 5. In this embodiment, the tibial 422 and the femoral tunnel 426 are prepared with corresponding internal threads adapted to engage the respective proximal 408 and distal fixation member 404.

2018264007 13 Nov 2018 [0054] In FIG. 12, the implant 400 is illustrated mounted to the insertion tool 416 and partially threaded into the tibial tunnel 422. The implant 400 is rotated about the axis 430 using the tool 416 to thread the distal fixation device 404 through the tibial tunnel 422, after which the implant is pushed distally to an entrance 432 of the femoral tunnel 426, as illustrated in FIG. 13. In an embodiment, the implant 400 includes distal and proximal fixation members having unequal diameters, as described herein in association with embodiments of the implant 200 illustrated in FIG. 5, and the distal fixation member 404 has a major thread diameter that is smaller than a minimum inner diameter of the threaded tibial tunnel 422. In this embodiment, the distal fixation member 404 is passed distally through the tibial tunnel 422 and to the entrance 432 of the femoral tunnel 426 without engaging the internal threads of the tibial tunnel 422. and without requiring rotation of the tool 416 and of the implant 400 [0055] The distal fixation member 404 is then threaded into the femoral tunnel 426 simultaneously with the proximal fixation member 408 being threaded into the tibial tunnel 422, as illustrated in FIG. 14. In an embodiment, the distal fixation member 404 includes one or more transverse bore, as described in association with the implant 250 illustrated in FIG. 6, and the insertion tool 416 includes one or more corresponding transverse aperture and a cannulation, as described herein in association with embodiments of the cannulated insertion tool 360 illustrated in FIG. 9. In this embodiment, a fluid may be injected into the surgical site through the tool 416 to provide medication or to enhance the fixation of the distal fixation member 404 in the femoral tunnel 426.

[0056] Referring now to FIG. 15, the tool 416 has been withdrawn proximally from the distal fixation member 404 positioned in the femoral tunnel 426, while remaining engaged with the proximal fixation member 408 in the tibial tunnel 422. In this position, rotation of the tool 416 rotates the proximal fixation member 408 within the tibial tunnel 422 to adjust tension on the flexible ligament portion 412 of the implant 400. In an embodiment, the proximal fixation member xx includes one or more transverse bore, as described herein in association with embodiments of the implant 250 illustrated in FIG. 6, and the insertion tool 416 includes one or more corresponding transverse aperture and a cannulation, as described herein in association with embodiments of the cannulated insertion tool 360 illustrated in FIG. 9. In this embodiment, a fluid may be injected into

2018264007 13 Nov 2018 the surgical site through the tool 416 to provide medication or enhance the fixation of the proximal fixation member 408 in the tibial tunnel 422. The tool 416 is fully withdrawn proximally from the implant 400 to complete the installation of the implant 400.

[0057] Referring now to FIGS. 16 and 17, the use of a toggle-type implant 450 and an associated installation tool 452 of the present invention in a surgical procedure is illustrated. Referring first to FIG. 16, prior to the installation of the toggle-type implant 450 in a knee 454, the knee 454 is prepared and positioned for ACL replacement surgery using conventional surgical tools and conventional surgical procedures. The implant 450 includes a toggle-type distal fixation member 456 as described herein in association with embodiments of the toggle-type implant 300 illustrated in FIG. 7. The implant 450 also includes a proximal bone block 458 and a flexible ligament member 460 interconnecting the distal fixation member 456 and the proximal bone block 458. The implant 450 also is seen to have an axial bore 462 for receiving the insertion tool 452. The insertion tool 452 includes a proximal handle 464 and a distal shaft 466 for engagement with the axial bore 462. The implant 450 is mounted on the tool 452 by passing the shaft 420 distally through the axial bore 462 in the proximal fixation member 458 and into the axial bore 462 in the distal fixation member 456.

[0058] A tibial bone tunnel 468 through a tibia 470 and a femoral bone tunnel 472 in a femur 474 are prepared using conventional surgical tools and techniques. The tibial tunnel 468 and the femoral tunnel 472 share a common axis 476. FIG. 16 illustrates the implant 450 mounted to the tool 452 for passing through the tibial tunnel 468 and to the femoral tunnel 472. In FIG. 17, the implant 450 is seen to have been passed through the tibial tunnel 468 and into the femoral tunnel 472, tension has been applied to the flexible ligament member 460, toggling the distal fixation member 456, thereby fixing it in the femoral tunnel 472. Also, tension has been applied to the flexible ligament member 460, for fixation of the proximal bone plug 458 with an interference screw 478. In an embodiment, the tension is applied through the grasping member 386 described herein in association with the tool 380 illustrated in FIG. 11. The tool 452 is withdrawn proximally from the implant 450 to complete the installation of the implant 450.

2018264007 13 Nov 2018 [0059] The implants, tools, and associated methods of the present invention have many advantages. The advantages include providing the surgeon with prepared, pre-sized implants for immediate placement in specified bone tunnels, saving the surgeon time and reducing the surgical skill required to perform an ACL repair surgery relative to conventional bone-tendon bone ACL repair surgeries where the surgeon often is required to manually shape oversized bone blocks to fit bone tunnels. Another advantage of the present invention is that the implant is self-fixating at one or both of the femoral and the tibial end, further reducing the labor and time required of the surgeon in fixating the implant. Further, the self-fixating implants reduce the number of foreign bodies left in the patient after surgery. By providing fixation members fabricated from the material of the bone blocks or their synthetic equivalents, the present invention provides not only fixation members that are integrated with an implant, but fixation members that are unitary with the material of the implant, making the implant a single part. Yet another advantage of the present invention is that it provides an implant that can be positioned in a joint and tensioned with a single insertion tool. Still another advantage of the present invention is that it provides a combination of an implant and a tool that can be used to conveniently inject a medicant or an adhesive selectively into a surgical site to enhance healing or fixation of the implant.

[0060] Although this invention has been shown and described with respect to detailed embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail may be made without departing from the spirit and scope of the claimed invention.

[0061] Throughout this specification and the claims which follow, unless the context requires otherwise, the word comprise, and variations such as comprises and comprising, will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

[0062] The reference to any prior art in this specification is not and should not be taken as an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.

2018264007 13 Nov 2018 [0063] This application is a divisional from Australian Application 2017210658.

The full disclosure of AU2017210658 is incorporated herein by reference.

Claims (8)

1. An implant comprising a tissue harvested from a mammal, the tissue including a ligament member having a first end and a second end, a first bone block attached substantially at the first end, a second bone block attached substantially at the second end, exterior screw threads on at least one of the first and the second bone block, the threads adapted for threaded engagement with internal screw threads formed in a tunnel in a bone of a living patient.

2. An implant comprising a graft ligament having a first end and a second end, a first bone block attached to the graft ligament substantially at the first end and adapted to fit within a tunnel in a bone, the tunnel having a wall, a second bone block attached substantially at the second end, the first bone block including an edge adapted to wedge against the wall in response to tension applied to the graft ligament by pulling on the second bone block.

3. A method for replacing an anterior cruciate ligament in a knee, the method comprising:

a) forming an internally screw threaded first tunnel through a tibia adjacent to the knee;

b) forming an internally screw threaded second tunnel in a femur adjacent to the knee;

c) providing an implant having;

i) a first fixation member having an axis, a first substantially cylindrical external surface about the axis, the first surface defining first external screw threads adapted for threaded engagement in the internally threaded first tunnel, the first external screw threads having a first major thread diameter and a first minor thread diameter, the first fixation member defining an axial bore therethrough;

ii) a second fixation member having a second substantially cylindrical external surface about the axis, the second surface defining second external screw threads adapted for threaded engagement in the internally threaded second tunnel, the second external screw threads having a second major thread diameter and a second minor thread

2018264007 13 Nov 2018 diameter, the second fixation member defining an axial bore at least partially therethrough; and iii) a flexible graft ligament member interconnecting the first fixation member and the second fixation member;

d) providing an implant insertion tool having;

i) an elongated shaft adapted for sliding engagement with the axial bore through the first fixation member and at least partially through the second fixation member; and ii) a handle fixed to the elongated shaft for positioning outside the axial bore;

e) slidingly engaging the tool with the first and the second fixation member along the axis;

f) passing the second fixation member through the internally threaded first tunnel;

g) simultaneously rotationally threading the first fixation member into the internally threaded first tunnel and the second fixation member into the internally threaded second tunnel.

4. The method of claim 3 wherein passing the second fixation member through the internally threaded first tunnel comprises engaging the second external threads in the internally threaded first tunnel and rotationally threading the second fixation member through the internally threaded first tunnel.

5. The method of claim 3 further comprising:

a) disengaging the tool from the second fixation member while leaving the tool engaged with the first fixation member;

b) tensioning the implant by rotating the tool and the first fixation member engaged therewith; and

c) disengaging the tool from the first fixation member after tensioning the implant.

6. The method of claim 3 further comprising injecting a fluid through the implant, wherein the implant defines at least one transverse bore in fluid communication with the

2018264007 13 Nov 2018 axial bore and at least one of the first and the second external surface, the tool further including a cannulation in fluid communication with the at least at least one transverse bore.

7. The method of claim 6, wherein the fluid is selected from the group consisting of an adhesive, a medicant and a lubricant.

8. A method for replacing a ligament in a knee of a patient, the method comprising:

a) preparing a tibial tunnel in a tibia adjacent to the knee and preparing a femoral tunnel in a femur adjacent to the knee;

b) providing an implant including a including a graft ligament having a first end and a second end, a first bone block attached to the first end and a second bone block attached to the second end, each of the first and the second bone block including an integral fixation device for fixation in a bone tunnel;

c) fixating the first bone block in the femoral tunnel using the first fixation device; and

d) fixating the second bone block in the tibial tunnel using the second fixation device.