LIGAMENT REPAIR SYSTEM AND METHOD
20220117720 · 2022-04-21
Assignee
Inventors
Cpc classification
A61B2017/0046
HUMAN NECESSITIES
A61F2002/0829
HUMAN NECESSITIES
A61F2002/0841
HUMAN NECESSITIES
A61F2002/0888
HUMAN NECESSITIES
A61F2002/0858
HUMAN NECESSITIES
A61F2002/0864
HUMAN NECESSITIES
International classification
Abstract
Embodiments of the disclosure are directed to a ligament repair system and method. The ligament repair system may include one or more of a femoral aimer assembly, a tibial aimer assembly, a femoral fixation assembly, and a tibial fixation assembly.
Claims
1. A ligament repair system comprising: a femoral aimer assembly comprising: a handle, a cannula configured to couple with the handle, the cannula having a cannulation with a longitudinal axis through which a guidewire may be inserted into a femur, and a protrusion at a distal end of the cannula with a center that is offset from a center of the longitudinal axis of the cannulation, wherein when the protrusion is placed in a hole in the femur, the offset distance between the protrusion and the longitudinal axis of the cannulation defines a predetermined distance between the hole and a guidewire that may be inserted through the cannulation; a tibial aimer assembly comprising: a base, a drill guide coupled to the base, a left aimer arm configured to releasably couple with the base, the left aimer arm comprising: a first leg configured to releasably couple with the base in a common plane with the base, and a left extension with a first main axis that extends from its proximal end to its distal tip, wherein the proximal end of the left extension is fixed to the first leg, a central portion of the left extension diverts to the left of the first main axis, and the distal tip of the left extension is configured to align with a central axis of the drill guide, and a right aimer arm configured to releasably couple with the base, the right aimer arm comprising: a second leg configured to releasably couple with the base in a common plane with the base, and a right extension with a second main axis that extends from its proximal end to its distal tip, wherein the proximal end of the right extension is fixed to the second leg, a central portion of the right extension diverts to the right of the second main axis, and the distal tip of the right extension is configured to align with a central axis of the drill guide; a femoral fixation assembly comprising: a first fixation device for coupling a first ligament bundle to the femur, and a second fixation device for coupling a second ligament bundle to the femur; and a tibial fixation assembly comprising: an exterior anchor with a proximal end, a distal end, and an interior opening, the exterior anchor configured to couple the first ligament bundle between an exterior portion of the exterior anchor and a hole in a tibia, and an internal anchor that fits substantially within the interior opening in the exterior anchor to couple the second ligament bundle relative to the exterior anchor.
2. The ligament repair system of claim 1, wherein the longitudinal axis of the cannulation of the femoral aimer assembly is coupled to the handle at an angle of about 45 degrees to a longitudinal axis of the handle.
3. The ligament repair system of claim 1, wherein the longitudinal axis of the cannulation of the femoral aimer assembly is coupled to the handle at an angle of about zero degrees to a longitudinal axis of the handle.
4. The ligament repair system of claim 1, wherein the protrusion of the femoral aimer assembly is substantially the size of the guidewire.
5. The ligament repair system of claim 1, wherein the protrusion of the femoral aimer assembly is substantially the size of a hole reamed to accept a ligament fixation device.
6. The ligament repair system of claim 5, wherein a tool used to create the reamed hole has a diameter between about 7 mm and 11 mm.
7. The ligament repair system of claim 1, wherein the center of the protrusion of the femoral aimer assembly is between about 7 mm and 11 mm from the center of the longitudinal axis of the cannulation.
8. The ligament repair system of claim 1, wherein the femoral aimer assembly is configured and sized such that when a first hole has been made in the femur to accept the protrusion and a second hole has been made in the femur with the protrusion in the first hole, and the first and second holes have been reamed, a bone bridge of about at least 2 mm exists between the first hole and the second hole.
9. The ligament repair system of claim 1, wherein the first leg of the left aimer arm of the tibial aimer releasably couples to the base along an arc such that when the first leg of the left aimer arm is moved along the arc, the distal tip of the left extension remains aligned with an extended central axis of the drill guide.
10. The ligament repair system of claim 1, wherein the second leg of the right aimer arm of the tibial aimer releasably couples to the base along an arc such that when the second leg of the right aimer arm is moved along the arc, the distal tip of the right extension remains aligned with an extended central axis of the drill guide.
11. The ligament repair system of claim 1, wherein the first ligament bundle is allograft.
12. The ligament repair system of claim 1, wherein the first ligament bundle is autograft.
13. The ligament repair system of claim 1, wherein the first ligament bundle is a synthetic graft substitute material.
14. The ligament repair system of claim 1, wherein the second ligament bundle is allograft.
15. The ligament repair system of claim 1, wherein the second ligament bundle is autograft.
16. The ligament repair system of claim 1, wherein the second ligament bundle is a synthetic graft substitute material.
17. The ligament repair system of claim 1, wherein the first and second ligament bundles are joined to each other away from one or more of their respective ends.
18. The ligament repair system of claim 1, wherein the exterior anchor is a pound-in anchor.
19. The ligament repair system of claim 1, wherein the exterior anchor has a wall along only a part of a perimeter of the exterior anchor between its proximal end and its distal end.
20. The ligament repair system of claim 1, wherein the exterior anchor has a continuous annular wall between its proximal end and its distal end.
21. The ligament repair system of claim 1, wherein the exterior anchor has an opening from its proximal end to its distal end.
22. The ligament repair system of claim 1, further comprising an inserter for inserting the exterior anchor, the inserter including a passageway through which the first ligament bundle may be passed while the exterior anchor is coupled to the inserter.
23. The ligament repair system of claim 1, wherein the internal anchor is configured to fix the second ligament against the interior opening in the exterior anchor.
24. The ligament repair system of claim 1, wherein the internal anchor is configured to fix the second ligament bundle against the tibia while the second ligament bundle is in an exterior anchor that has a wall along only a part of a perimeter of the exterior anchor between its proximal end and its distal end.
25. A femoral aimer assembly comprising: a handle; a cannula configured to couple with the handle, the cannula having a cannulation with a longitudinal axis through which a guidewire may be inserted into a femur; and a protrusion at a distal end of the cannula with a center that is offset from a center of the longitudinal axis of the cannulation, wherein when the protrusion is placed in a hole in the femur, the offset distance between the protrusion and the longitudinal axis of the cannulation defines a predetermined distance between the hole and a guidewire that may be inserted through the cannulation.
26. The femoral aimer assembly of claim 25, wherein the longitudinal axis of the cannulation of the femoral aimer assembly is coupled to the handle at an angle of about 45 degrees to a longitudinal axis of the handle.
27. The femoral aimer assembly of claim 25, wherein the longitudinal axis of the cannulation of the femoral aimer assembly is coupled to the handle at an angle of about zero degrees to a longitudinal axis of the handle.
28. The femoral aimer assembly of claim 25, wherein the protrusion is substantially the size of the guidewire.
29. The femoral aimer assembly of claim 25, wherein the protrusion is substantially the size of a hole reamed to accept a ligament fixation device.
30. The femoral aimer assembly of claim 29, wherein a tool used to create the reamed hole has a diameter between about 7 mm and 11 mm.
31. The femoral aimer assembly of claim 25, wherein the center of the protrusion is between about 7 mm and 11 mm from the center of the longitudinal axis of the cannulation.
32. The femoral aimer assembly of claim 25, wherein the femoral aimer assembly is configured and sized such that when a first hole has been made in the femur to accept the protrusion and a second hole has been made in the femur with the protrusion in the first hole, and the first and second holes have been reamed, a bone bridge of about at least 2 mm exists between the first hole and the second hole.
33. The femoral aimer assembly of claim 25, further comprising a first spur near the distal end of the cannula that extends away from the longitudinal axis of the cannula and is substantially perpendicular to a length of the protrusion.
34. The femoral aimer assembly of claim 33, further comprising a second spur near the distal end of the cannula that extends away from the longitudinal axis of the cannula opposite from the first spur and is substantially perpendicular to a length of the protrusion.
35. A tibial aimer assembly comprising: a base; a drill guide coupled to the base; a left aimer arm configured to releasably couple with the base, the left aimer arm comprising: a first leg configured to releasably couple with the base in a common plane with the base, and a left extension with a first main axis that extends from its proximal end to its distal tip, wherein the proximal end of the left extension is fixed to the first leg, a central portion of the left extension diverts to the left of the first main axis, and the distal tip of the left extension is configured to align with a central axis of the drill guide; and a right aimer arm configured to releasably couple with the base, the right aimer arm comprising: a second leg configured to releasably couple with the base in a common plane with the base, and a right extension with a second main axis that extends from its proximal end to its distal tip, wherein the proximal end of the right extension is fixed to the second leg, a central portion of the right extension diverts to the right of the second main axis, and the distal tip of the right extension is configured to align with a central axis of the drill guide.
36. The tibial aimer assembly of claim 35, wherein the first leg of the left aimer arm of the tibial aimer releasably couples to the base along an arc such that when the first leg of the left aimer arm is moved along the arc, the distal tip of the left extension remains aligned with an extended central axis of the drill guide.
37. The tibial aimer assembly of claim 35, wherein the second leg of the right aimer arm of the tibial aimer releasably couples to the base along an arc such that when the second leg of the right aimer arm is moved along the arc, the distal tip of the right extension remains aligned with an extended central axis of the drill guide.
38. A tibial fixation assembly comprising: an exterior anchor with a proximal end, a distal end, and an interior opening, the exterior anchor configured to couple a first ligament bundle between an exterior portion of the exterior anchor and a hole in a tibia, and an internal anchor that fits substantially within the interior opening in the exterior anchor to couple a second ligament bundle relative to the exterior anchor.
39. The tibial fixation assembly of claim 38, wherein the exterior anchor is a pound-in anchor.
40. The tibial fixation assembly of claim 38, wherein the exterior anchor has a wall along only a part of a perimeter of the exterior anchor between its proximal end and its distal end.
41. The tibial fixation assembly of claim 38, wherein the exterior anchor has a continuous annular wall between its proximal end and its distal end.
42. The tibial fixation assembly of claim 38, wherein the exterior anchor has an opening from its proximal end to its distal end.
43. The tibial fixation assembly of claim 38, further comprising an inserter for inserting the exterior anchor, the inserter including a passageway through which the first ligament bundle may be passed while the exterior anchor is coupled to the inserter.
44. The tibial fixation assembly of claim 38, wherein the internal anchor is configured to fix the second ligament against the interior opening in the exterior anchor.
45. The tibial fixation assembly of claim 38, wherein the internal anchor is configured to fix the second ligament bundle against the tibia while the second ligament bundle is in an exterior anchor that has a wall along only a part of a perimeter of the exterior anchor between its proximal end and its distal end.
46. A method of implanting a posterior cruciate ligament (PCL) replacement graft in a patient's knee comprising: fixing an anterolateral bundle (ALB) graft and a posteromedial bundle (PMB) graft to the patient's femur; preparing the patient's tibia to receive the ALB graft and the PMB graft; positioning the ALB graft and the PMB graft through the tibia for fixation; positioning the patient's knee at about 90 degrees of flexion, tensioning the ALB relative to the tibia, and fixing the ALB relative to the tibia by placing an exterior anchor with a proximal end, a distal end, and an interior opening in a tibial tunnel prepared in the patient's tibia in which the ALB is located; and positioning the patient's knee at about zero degrees of flexion, tensioning the PMB relative to the tibia, and fixing the PMB relative to the tibia by placing an interior anchor in the interior opening of the exterior anchor in which the PMB is located.
47. The method of claim 46, wherein fixing the ALB graft and the PMB graft to the patient's femur includes placing the ALB and the PMB in blind holes.
48. The method of claim 46, wherein fixing the ALB graft and the PMB graft to the patient's femur includes using a femoral aimer assembly to locate a first hole at an anatomically correct location for an ALB.
49. The method of claim 48, wherein fixing the ALB graft and the PMB graft to the patient's femur includes using the femoral aimer assembly to create a second hole relative to the first hole at an anatomically correct location for a PMB by placing a protrusion of the femoral aimer assembly in the first hole and creating the second hole through a cannulation in the femoral aimer assembly, wherein the cannulation is a predetermined offset distance from the protrusion.
50. The method of claim 49, wherein using the femoral aimer assembly to locate the first hole at an anatomically correct location for an ALB includes using a spur near the distal end of the femoral aimer assembly to estimate the location of the femoral aimer assembly from an edge of a cartilage to bone interface, and using the femoral aimer assembly to locate the hole at an anatomically correct location for a PMB includes using the spur near the distal end of the femoral aimer assembly to estimate the location of the femoral aimer assembly from an edge of a cartilage to bone interface.
51. The method of claim 46, wherein fixing the ALB graft and the PMB graft to the patient's femur includes pulling one or both of the grafts through an anterolateral portal and passing the one or more grafts into respective holes in the femur with the aid of one or more guidewires used to create the respective holes in the femur.
52. The method of claim 46, wherein preparing the patient's tibia to receive the ALB graft and the PMB graft includes drilling a hole in the patient's tibia through a correct anatomical PCL footprint location using an extension on a drill guide that diverts around the patient's tibial eminence and ACL.
53. The method of claim 46, wherein fixing the ALB relative to the tibia by placing an exterior anchor may include implanting a pound-in anchor.
54. The method of claim 46, wherein fixing the ALB relative to the tibia by placing an exterior anchor includes implanting an anchor with a wall along only a part of a perimeter of the exterior anchor between its proximal end and its distal end.
55. The method of claim 46, wherein fixing the ALB relative to the tibia by placing an exterior anchor includes implanting an anchor with a continuous annular wall between its proximal end and its distal end.
56. The method of claim 46, wherein fixing the PMB relative to the tibia by placing the interior anchor in the interior opening of the exterior anchor in which the PMB is located includes fixing the PMB between the exterior anchor and the interior anchor.
57. The method of claim 46, wherein fixing the PMB relative to the tibia by placing the interior anchor in the interior opening of the exterior anchor in which the PMB is located includes fixing the PMB between a portion of the tibia exposed through a wall of the exterior anchor and the interior anchor.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Reference to the detailed description, combined with the following figures, will make the disclosure more fully understood, wherein:
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DETAILED DESCRIPTION
[0036] In the following description, like components have the same reference numerals, regardless of different illustrated examples. To illustrate examples clearly and concisely, the drawings may not necessarily reflect appropriate scale and may have certain features shown in somewhat schematic form. The disclosure may describe and/or illustrate features in one example, and in the same way or in a similar way in one or more other examples, and/or combined with or instead of the features of the other examples.
[0037] In the specification and claims, for the purposes of describing and defining the disclosure, the terms “about” and “substantially” represent the inherent degree of uncertainty attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” moreover represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. Open-ended terms, such as “comprise,” “include,” and/or plural forms of each, include the listed parts and can include additional parts not listed, while terms such as “and/or” include one or more of the listed parts and combinations of the listed parts.
[0038] An embodiment of the disclosure is a ligament repair system that includes collectively, a femoral aimer assembly 100, as shown in
[0039] An embodiment of the femoral aimer assembly 100 is illustrated in
[0040] The cannula 120 shown in
[0041] In some embodiments, the protrusion 127 may be substantially the same cross-sectional size or diameter as the guidewire inserted through the cannulation 122 and into the femur. In other embodiments, the protrusion 127 may be substantially the same cross-sectional size or diameter as a reamed hole in the femur 1000. For example, a hole 1001 (
[0042] The tibial aimer assembly 200 illustrated in
[0043] The left aimer arm 230 shown includes a first leg 231 configured to releasably couple with the base 201 in a common plane with the base 201. In the illustrated embodiment, a knob 211 is located on the base 201 such that when the knob 211 is tightened, sliding movement between the first leg 231 of the left aimer arm 230 along the arc of the first leg 231 is restricted. When the knob 211 is loosened, the first leg 231 is released and allowed to slide relative to the base 201 along the arc of the first leg 231. The first leg 231 of the left aimer arm 230 of the illustrated embodiment is shaped in cooperation with the base 201 such that when the first leg 231 of the left aimer arm 230 is moved along its arc, the distal tip 237 of a left extension 235 remains aligned with an extended central axis of the drill guide 210.
[0044] The left aimer arm 230 shown includes the left extension 235 with a first main axis 239 (
[0045] The right aimer arm 240 shown in
[0046] The right aimer arm 240 shown includes the right extension 245 with a second main axis 249 (
[0047] The femoral fixation assembly of the ligament repair system may include one or more fixation devices, such as but not limited to interference screws, pound-in anchors, and expanding anchors. In some embodiments, an ALB is coupled with a metal interference screw. The metal interference screw may be a nominal 7 mm diameter screw in some embodiments. In some embodiments, a PMB is coupled with a resorbable screw, such as but not limited to a BIOSURE REGENESORB brand screw offered by Smith and Nephew in some embodiments. The resorbable screw may be a nominal 7 mm diameter screw in some embodiments. Other effective combinations of screws or fastener types may be used in other embodiments.
[0048] The tibial fixation assembly 300, as shown in multiple embodiments in
[0049] An insertion cannula 310 and an inserter 320 for inserting the exterior anchor 350 are illustrated in
[0050] The exterior anchor 360 illustrated in
[0051] An inserter 330 for inserting the exterior anchor 360 is illustrated in
[0052] An example internal anchor 370 is depicted in
[0053] A method of implanting a PCL replacement graft in a patient's knee is described in context of the devices illustrated in
[0054] As shown in
[0055] Fixing one or both of the ALB graft and the PMB graft to the femur 1000 may include using implants or fixation devices to secure graft connections to the femur 1000. The one or more fixation devices that may be used include but are not limited to interference screws, pound-in anchors, and expanding anchors. In some embodiments, a metal interference screw may be used. The metal interference screw may be a nominal 7 mm diameter in some embodiments. In some embodiments, a resorbable screw, such as but not limited to a BIOSURE REGENESORB brand screw offered by Smith and Nephew may be used. The resorbable screw may be a nominal 7 mm diameter screw in some embodiments. Other effective combinations of screws, fastener types, and fixation devices may be used in other embodiments.
[0056] In some embodiments, fixing the ALB graft and the PMB graft to the patient's femur includes pulling one or both of the grafts through an anterolateral portal into the knee joint. Some embodiments may also include passing one or both of the ALB graft and the PMB graft into respective first and second holes in the femur with the aid of one or more guidewires used to create the respective first and second holes in the femur.
[0057] The method of implanting a PCL replacement graft in a patient's knee also includes the act of preparing the patient's tibia to receive the ALB graft and the PMB graft. In some embodiments, the act of preparing the patient's tibia to receive the ALB graft and the PMB graft includes drilling a hole in the patient's tibia through a correct anatomical PCL footprint location using an extension on a drill guide that diverts around the patient's tibial eminence and ACL, where the distal tip of the extension provides a drilling location and a target toward which drilling will be accomplished. Some methods may include selecting an extension from a set of extensions that are configured for either right or left diversion around the patient's tibial eminence and ACL. In some embodiments, preparing the patient's tibia includes using the DIRECTOR brand guide system and the ACUFEX brand Tibial Drill Guide, both offered by Smith and Nephew. Preparing the patient's tibia may include locating a distal tip of 237, 247 of a PCL tibial aimer, such as the aimer arms 230, 240, on the center of a native PCL tibial footprint and drilling a guidewire 260, such as a 2.4 mm guidewire, into the tibia at an angle of about 55 degrees. A reamer may be used to widen the hole created by the guidewire. For example and without limitation, a cannulated 12 mm reamer, such as an acorn reamer, may be used to prepare the patient's tibia. With the tibia prepared, the ALB graft and the PMB graft may be positioned through the tibia for fixation. The grafts may be moved through the prepared tibia with, for example and without limitation, a commercially available GORE SMOOTHER or functionally similar device.
[0058] The method of implanting a PCL replacement graft in a patient's knee also includes the act of positioning the patient's knee at about 90 degrees of flexion, tensioning the ALB relative to the tibia, and fixing the ALB relative to the tibia by placing an exterior anchor 350, 360 with a proximal end 351, 361, a distal end 352, 362, and an interior opening 355, 365 in a tibial tunnel (hole 2001,
[0059] In another act of the method of implanting a PCL replacement graft in a patient's knee, the patient's knee is positioned at about zero degrees of flexion, the PMB is tensioned relative to the tibia, and the PMB (graft 390) is fixed relative to the tibia by placing an interior anchor 370 (
[0060] Various embodiments of an instrument set and implants in whole or in their components individually may be made from any biocompatible material. For example and without limitation, biocompatible materials may include in whole or in part: non-reinforced polymers, reinforced polymers, metals, ceramics, adhesives, reinforced adhesives, and combinations of these materials. Reinforcing of polymers may be accomplished with carbon, metal, or glass or any other effective material. Examples of biocompatible polymer materials include polyamide base resins, polyethylene, low density polyethylene, polymethylmethacrylate (PMMA), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), a polymeric hydroxyethylmethacrylate (PHEMA), and polyurethane, any of which may be reinforced. Example biocompatible metals include stainless steel and other steel alloys, cobalt chrome alloys, zirconium, oxidized zirconium, tantalum, titanium, titanium alloys, titanium-nickel alloys such as Nitinol and other superelastic or shape-memory metal alloys.
[0061] Terms such as proximal, distal, against, left, right, and the like have been used relatively herein. However, such terms are not limited to specific coordinate orientations, distances, or sizes, but are used to describe relative positions referencing particular embodiments. Such terms are not generally limiting to the scope of the claims made herein. Any embodiment or feature of any section, portion, or any other component shown or particularly described in relation to various embodiments of similar sections, portions, or components herein may be interchangeably applied to any other similar embodiment or feature shown or described herein.
[0062] While embodiments of the disclosure have been illustrated and described in detail in the disclosure, the disclosure is to be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the disclosure are to be considered within the scope of the disclosure.