WO2017151833A1

WO2017151833A1 - Soft tissue repair instruments and method

Info

Publication number: WO2017151833A1
Application number: PCT/US2017/020309
Authority: WO
Inventors: Joseph Carney; Kurt Spindler; Daniel HABERMAN; Oliver STREIT
Original assignee: Smith & Nephew, Inc.
Priority date: 2016-03-02
Filing date: 2017-03-02
Publication date: 2017-09-08

Abstract

Embodiments of the invention include instruments and methods useful in accomplishing soft tissue repair. Some embodiments may particularly be directed to creating a graft tunnel for an anterior cruciate ligament to be implanted in a repair procedure. Instruments may include a guide pin (1) and a set of sequential dilators (11, 22, 33) over which a working cannula (40, 50) may be inserted. The guide pin (1) may then be used with cannulated hole creation instruments (70) such as cannulated drills and reamers to create the graft tunnel (515).

Description

SOFT TISSUE REPAIR INSTRUMENTS AND METHOD

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority of U.S. Provisional Application No. 62/302,505, filed March 2, 2016.

FIELD OF THE INVENTION

[0002] The present invention relates generally to the field of medical devices, and more particularly relates to instruments and methods for repairing soft tissue. Some instalments of embodiments of the invention include a guide pin, sequential dilators sized to fit over the guide pin, and a working cannula size to fit over the sequential dilators and through which a graft tunnel may be created.

BACKGROUND

[0003] Many techniques for soft tissue repair, such as anterior cruciate ligament grafting or replacement, are known in the prior art. For example, common practices include trans-tibial drilling, femoral drilling through, and anteromedial portal techniques, as well as other outside-in, inside-out, and all -inside drilling of bone tunnels. However, many of these techniques require specialized disposable instruments such as flip-cutter drills and disposable cannulas. Another useful design criterion that many of these techniques meet, although at a high financial cost, is a limited cross-section of the instruments used.

[0004] It would be advantageous to provide a reusable set of access instruments with a limited cross-section that may be used to gain access to a surgical site. An improved instrument may also include devices and methods for visualizing and establishing a trajectory for a graft tunnel to be placed through a bone.

SUMMARY

[0005] An embodiment of the invention is an instrument set that includes a guide pin, at least a first dilator, a working cannula, and a cannulated hole creation instrument. The guide pin may be configured to be inserted through a patient's soft tissue m a first direction and to dock with a bone in which a graft tunnel is to be created. The first dilator may be sized to fit over and be guided along the guide pin and move the patient's soft tissue away from the guide pin. The working cannula may be sized to fit over and be guided in the first direction of the guide pin, toward the bone, and move the patient's soft tissue away from the guide pin, wherein the working cannula provides a working channel through which the graft tunnel may be created. The cannulated hole creation instrument may be configured to fit over and be guided along the guide pm to create the graft tunnel along a trajectory of the guide pin.

[0006] Another embodiment of the invention is a working cannula through which a graft tunnel may be created in a bone near a distal end of the working cannula. The working cannula may include one or more fixation pin holes through which fixation pins may be placed into the bone to secure the working cannula relative to the bone.

[0007] Yet another embodiment of the invention is a method of soft tissue repair. The method may include inserting a guide pin through skin and into a bone to which soft tissue is to be attached and placing a first dilator sized to fit over and be guided along the guide pin over the guide pin and moving the first dilator toward the bone to move soft tissue away from the guide pin. A user may then successively place one or more additional dilators over the guide pin and the first dilator and move the one or more additional dilators toward the bone to successively move soft tissue away from the guide pin. The method may also include placing a w orking cannula over the guide pin and all of the dilators placed over the guide pin and moving the working cannula toward the bone to mo ve soft tissue away from the guide pin, and removing all of the dilators placed over the guide pin by moving the dilators away from, the bone and over the guide pin, thereby leaving the guide pin in the bone and the working cannula near the bone to provide a working channel through which a graft tunnel may be created. The method may additionally include placing a cannulated hole creation instrument over the guide pin and moving the hole creation instrument over the guide pin and into the bone to create the graft tunnel along a trajectory of the guide pin.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a perspective view of a patient's knee into which two instrument penetrations have been made. [0009] FIG. 2 is perspective view of a femur of the knee depicted in FIG. 1 with soft tissues and a tibia and fibula removed for clarity, and showing a dilator inserted over a guide pin.

[00010] FIG. 3 is a perspective view of the femur and instruments of FIG. 2 with an additional dilator.

[00011] FIG. 4 is a perspective view of a working cannula.

[00012] FIG. 5 is perspective view of the working cannula of FIG. 4 added to the femur and instruments of FIG. 3.

[00013] FIG. 6 is a perspective view of a handle that may be coupled to the working cannula (as shown in FIG. 7).

[00014] FIG. 7 is a perspective view of a fixation pin in position to be attached through a fixation pin hole in the working cannula of FIGS. 4 and 5.

[00015] FIG. 8 is a perspective view of the instalments of FIG. 7 with additional fixation pins and a cannulated reamer added and the dilators and handle removed.

[00016] FIG. 9 is a perspective view of the cannulated reamer of FIG. 8 advanced into the femur and by a cannulated drill with all other instruments and tissues removed for clarity.

[00017] FIG. 10 is a perspective view of the working cannula and fixation pins of FIG. 8 and a stopper.

[00018] FIG. 1 1 is a more detailed view of the stopper of FIG. 10.

[00019] FIG. 12 is an alternate embodiment where a third dilator is used to create a larger soft tissue opening,

[00020] FIG. 13 is a perspective view of the embodiment of FIG. 12 showing a larger working cannula around the third dilator. [00021] FIG. 14 is a perspective view of the larger working cannula of FIG. 13 with fixation pins coupling the larger working cannula to the femur.

[00022] FIG. 15 is a perspective vie of a larger stopper sized to fit within the larger working cannula of FIGS. 13 and 14.

DETAILED DESCRIPTION

[00023] An embodiment of an instrument set 100 and its use is illustrated in FIGS. 1-1 1 as applied to a knee joint 500, and in particular as applied to preparing a femur 510 to receive an anterior cruciate ligament soft tissue graft. Many other surgical procedures requiring or benefiting from soft tissue dilation to gain access to a portion of a patient's body may benefit from, embodiments of this invention. For example and without limitation, a pectoralis major repair procedure may by improved with the use of this invention.

[00024] The illustrated instrument set 100 includes a guide pin 1 configured to be inserted through a patient's soft tissue, as shown in FIG. 1. The instrument set 100 may be used in combination with another instrument set 101 that provides a second access approach in a two incision surgical procedure, such as a two incision anterior cruciate ligament repair. Insertion of the guide pin 1 may be aided by one or both of a sharpened distal tip of the guide pin 1 or by an incision made by a cutting instrument such as a scalpel 99, as illustrated in FIG. 1. In addition or as an alternative to a sharpened distal tip, embodiments of the guide pin may be self-drilling and configured to be attached to a drill and advanced through soft tissue, whether being rotated or not, and may also be configured to be advanced into bone. The scalpel 99 may also be used to enlarge an opening in soft tissue to enable further enlargement of the soft tissue with dilators or other instalments. The trajectory of the guide pin 1 may be established in a direction that is desired for a final direction of a graft tunnel to be made in the bone, as will be discussed in more detail with method embodiments disclosed herein.

[00025] ^'The instrument set 100 depicted also includes a first dilator 11. The first dilator 11 is sized to fit over and be guided along the guide pin 1. As the first dilator 11 is guided along the guide pin 1 coward the femur 510, die patient's soft tissue is moved away from the guide pin 1. In the embodiment of the first dilator 11 shown, a first tapered distal end 12 is provided that acts as a circular wedge to move soft tissue away from the guide pm 1 as the first dilator 11 is guided along the guide pin 1 toward the femur 510. In other embodiments, other shapes may be used to encourage soft tissue movement away from the guide pin 1. The relatively thin walls of dilators of some embodiments in combination with the elasticity of the soft tissue being dilated may be adequate to achie ve mo vement of soft tissue away from the guide pin 1, even without a distal tapered end for those embodiments.

[00026] A second dilator 22 configured to fit over the first dilator 11 and move the patient^'s soft tissue away from the guide pin 1 as the second dilator 22 is moved toward the femur 510 is illustrated in FIGS. 3, 5, and 7. In the embodiment of the second dilator 22 shown, a second tapered distal end 23 is provided that acts as a circular wedge to move soft tissue away from the guide pin 1 as the second dilator 22 is guided along the first dilator 11 and guide pin 1 toward the femur 510. In other embodiments, other shapes may be used to encourage soft tissue movement away from the guide pin 1. The relatively thin walls of dilators of some embodiments in combination with the elasticity of the soft tissue being dilated may be adequate to achieve movement of soft tissue away from the guide pin 1, even without a distal tapered end for those embodiments.

[00027] A working cannula 40 sized to fit over and be guided in the first direction (insertion direction) of the guide pin 1, toward the femur 510 is illustrated in FIGS. 4- 6, 7, 8 and 10. The working cannula 40 shown is guided over the guide pin 1 , the first dilator 11 , and the second dilator 22. However, in other embodiments an instrument set may not include the use of a second dilator, and in some embodiments, there may be more than two dilators. The working cannula 40 depicted is configured to move the patient's soft tissue away from the guide pin 1. In particular, an outer diameter of the working cannula 40 is tapered from near a proximal end of the working cannula 40 to a distal end of the working cannula 40. In the illustrated embodiment, the second dilator 22 is sized to fit closely within the working cannula 40. In other embodiments, the fit may have a greater tolerance. The working cannula 40 shown provides a working channel through which a graft tunnel 515 (FIG. 9) may be created.

[00028] The working cannula 40 includes multiple fixation pin holes 44, as shown in FIGS. 4, 5, and 7, The working cannula 40 includes a flange 42 near a proximal end of the working cannula 40, as depicted in FIGS. 4, 5, 7, 8, and 10. The flange 42 shown is substantially perpendicular to a longitudinal axis of the working cannula 40. The fixation pin holes 44 are in the flange 42 in the illustrated embodiment, but in other embodiments may be in any other effective part of a working cannula. Fixation pins 45 (FIGS. 7, 8, and 10) may be placed through the fixation pin holes 44 and into the femur 510 to secure the working cannula 40 relative to the femur 510. in other embodiments, a working cannula may be secured by fixation pins to whatever bone or other structure near which the working cannula is positioned. Two or more of the fixation pin holes 44 shown are not substantially parallel with each other. In other words, at least two of the longitudinal axes of the fixation pin holes 44 are not substantially parallel with each other. This configuration in the illustrated embodiments is seen most clearly in FIGS. 8 and 10 where some fixation pins 45 that closely fit along the longitudinal axes of the fixation pin holes 44 are not substantially parallel, but converge or diverge from one another. Converging and diverging fixation pins may be useful in some embodiments to create a more secure fixation by- creating a structure where the working cannula 40 cannot be pulled directly away from the femur 510 without inducing bending stress in one or more of the fixation pins 45. In other words, with such a structure sliding along the axis of at least one of the fixation pins 45 causes bending stress to be induced in at least one of the other non-parallel fixation pins 45. This structure further permits fixation of a working cannula against a bone without necessarily requiring heads on the fixation pins.

[00029] The fixation pins 45 illustrated are configured to be driven into bone with an impaction force delivered by an instrument such as a hammer or mallet. However, in other embodiments fixation pins may be of any other effective design. For example and without limitation, fixation pins of some embodiments may be threaded such that they must be rotated to move the pins into bone effectively. Fixation pins of some embodiments may be expandable, at least in the portion in which the fixation pins are engaged with bone.

[00030] Some embodiments of the instrument set include a handle 60 (FIGS. 6 and 7) configured to couple with the working cannula 40 near a proximal end of the working cannula 40. Tins configuration provides, among other benefits, an extension to the working cannula 40 that may be grasped by a user of the working cannula 40. The handle 60 illustrated includes a connector 67 at a distal end of the handle 60 that is sized to fit within the opening 47 (FIGS. 4, 5, 8, and 10) to couple the handle 60 with the working cannula 40. [00031] The instrument set may also include a cannulated hole creation instrument 70, as shown in FIGS. 8 and 9. The cannulated hole creation instrument 70 is configured to fit over and be guided along the guide pin 1 to create the graft tunnel 515 along a trajectory of the guide pin 1. The cannulated hole creation instrument 70 is a cannulated reamer. Other embodiments of a cannulated hole creation instrument may be a cannulated drill bit or any other instrument or instrument component configured to effectively create or enlarge a hole. A cannulated drill 80 is shown in FIG. 9 connected to the cannulated hole creation instrument 70. The cannulated drill 80 may be electrically or pneumatically driven or driven by any other effective source, including manually driven by direct or mechanically advantaged force of a user.

[00032] A stopper 48 is illustrated in FIGS. 10 and 11 that may be placed in the working cannula 40 to close the working cannula 40 and create a seal behind which the joint may be pressurized so that an endoscopic procedure may be accomplished. For example, all or a portion of a procedure may be accomplished through a portal through which instruments of the instrument set 101 (FIG. 1) are inserted.

Additionally or in combination, a portion of the stopper 48 may include an access portal that seals or partially seals for fluid retention but through which instruments may be inserted to accomplish surgical acts. To achieve a seal and create an interference fit, the stopper 48 includes O-rings 49. Any other effective sealing or coupling stmcture may be used in other embodiments, including but not limited to, a stopper that threads into a working cannula with internal threads.

[00033] An embodiment of the instrument set with a third dilator 33 and a larger w orking cannula 50 is illustrated in FIGS. 12-15. The instrument set of FIGS. 12-15 includes the same guide pin 1, first dilator 1 1, second dilator 22, fixation pins 45, and handle 60 as previously described herein, but adds the third dilator 33, die working cannula 50, and a stopper 58. The third dilator 33 is configured to fit over the second dilator 22, and move the patient's soft tissue away from, the guide pin 1 as the third dilator 33 is moved toward the femur 510. The third dilator 33 is sized to fit within the working cannula 50, as illustrated in FIG. 13. A dilator system of the types disclosed may have any practical number of final dilator and cannula sizes.

[00034] The working cannula 50 shown is guided over the guide pin 1, the first dilator 11, the second dilator 22, and the third dilator 33. However, in other embodiments an instrument set may not include the use of a second or third dilator, and in some embodiments, there may be more than three dilators. The working cannula 50 depicted is configured to move the patient's soft tissue away from the guide pin 1. In particular, an outer diameter of the working cannula 50 is tapered from near a proximal end of the working cannula 50 to a distal end of the working cannula 50. In the illustrated embodiment, the third dilator 33 is sized to fit closely within the working cannula 50. In other embodiments, the fit may have a greater tolerance. The working cannula 50 shown provides a working channel through which a graft tunnel 515 (FIG. 9) may be created.

[00035] The working cannula 50 includes multiple fixation pin holes 54, as shown in FIG. 13. The working cannula 50 includes a flange 52 near a proximal end of the working cannula 50, as depicted in FIGS. 13 and 14. The flange 52 shown is substantially perpendicular to a longitudinal axis of the working cannula 50. The fixation pin holes 54 are in the flange 52 in the illustrated embodiment, but in other embodiments may be in any other effective part of a working cannula. Fixation pins 45 (FIG. 14) may be placed through the fixation pin holes 54 and into the femur 510 to secure the working cannula 50 relative to the femur 510. In other embodiments, a w orking cannula may be secured by fixation pins to whatever bone or other structure near which the working cannula is positioned. Two or more of the fixation pin holes 54 shown are not substantially parallel with each other. In other words, at least two of the longitudinal axes of the fixation pin holes 54 are not substantially parallel with each other. This configuration in the illustrated embodiments is seen most clearly in FIG. 14, where some fixation pins 45 that closely fit along the longitudinal axes of the fixation pin holes 54, are not substantially parallel but converge or diverge from one another. Converging and diverging fixation pins may be useful in some embodiments to create a more secure fixation by creating a structure where the working cannula 50 cannot be pulled directly away from the femur 510 without inducing bending stress in one or more of the fixation pins 45. In other words, with such a structure sliding along the axis of at least one of the fixation pins 45 causes bending stress to be induced in at least one of the other non-parallel fixation pins 45. This structure further permits fixation of a working cannula against a bone without necessarily requiring heads on the fixation pins.

Θ0036] Some embodiments of the instrument set include the handle 60, as described herein and as depicted in FIGS. 6 and 7, configured to couple with the working cannula 50 near a proximal end of the working cannula 50. This configuration provides, among other benefits, an extension to the working cannula 50 that may be grasped by a user of the working cannula 50. The handle 60 illustrated includes a connector 67 at a distal end of the handle 60 that is sized to fit within the opening 57 (FIGS. 13 and 14) to couple the handle 60 with the working cannula 50.

[00037] The cannulated hole creation instrument 70 (FIGS. 8 and 9), and variations describe herein, may be configured to fit over and be guided along the guide pin 1 shown in FIGS. 12 and 13 after removal of dilators 1 1 , 22, 33 to create the graft tunnel 515 along a trajectory of the guide pin 1.

[00038] The stopper 58 is illustrated in FIG. 15 and may be placed in the working cannula 50 to close the working cannula 50 and create a seal behind which the joint may be pressurized so that an endoscopic procedure may be accomplished. For example, all or a portion of a procedure may be accomplished through a portal through which instruments of the instrument set 101 (FIG. 1) are inserted.

Additionally or in combination, a portion of the stopper 58 may include an access portal that seals or partially seals for fluid retention but through which instruments may be inserted to accomplish surgical acts. To achieve a seal and create an interference fit, the stopper 58 includes O-rings 59. Any other effective sealing or coupling structure may be used in other embodiments, including but not limited to, a stopper that threads into a working cannula with internal threads.

[00039] An embodiment of the invention is a working cannula standing alone, such as either of the working cannulas 40, 50, along with all variations described herein or substantially within the scope of the description provided. Such working cannulas may be used alone or as part of an instrument set, such as the instrument set 1 0.

[00040] Embodiments of the invention are directed to methods of soft tissue repair. Methods will be described with respect to use of the instrument set 100 with one or both of the working cannulas 40, 50, but are equally applicable to other operatively effective instalments and instrument sets. The embodiments illustrated show preparation for soft tissue repair of an anterior cruciate ligament, but other embodiments may include any soft tissue repair, including but not limited to a pectoralis major repair procedure. An act of the method may include inserting a guide pin, such as the guide pin 1 shown in FIGS. 1-3, 5, 7, 8, 12, and 13, through skin and into a bone to which soft tissue is to be attached. In the illustrated embodiments, the bone in which the guide pin 1 is inserted is the femur 510, but may be inserted into other bones in other applications of the method. Some method embodiments may include the act of orienting the guide pin in a direction that is a desirable trajectory for creating of a graft tunnel. For example, orienting the guide pin along a desirable trajectory for an anterior cruciate ligament tunnel in a femur. In some embodiments, inserting the guide pin may include the act of using imaging or image guidance to determine one or more of a desired placement and trajectory of the guide pin relative to the bone into which the guide pm is being inserted. Any type of effective imaging technology may be used, including but not limited to one or more of, radiographic, magnetic resonance, infrared, and optical, and may include the use of fiducials that may be attached to bone or other anatomical structures. The act of inserting a guide pin may include making an incision through skin or other soft tissue. In some embodiments, a guide pin may be inserted without the use of an incision, but an incision may be made adjacent to the inserted guide pin to create enough of an opening in the soft to tissue to permit other instruments to be advanced along or near the guide pin.

[00041] Some method embodiments include the act of placing a first dilator, such as first dilator 11, sized to fit over and be guided along the guide pin over the guide pin and moving the first dilator toward the bone to move soft tissue away from the guide pin. As depicted in the example embodiment, the first dilator 1 1 fits over the guide pin 1 and may be moved toward the femur 510 (FIG. 2) to move soft tissue (FIG. 1) away from the guide pin 1. Method embodiments may also include successively placing one or more additional dilators over the guide pin and the first dilator and moving the one or more additional dilators toward the bone to

successively move soft tissue away from the guide pin. Successive placement of one additional dilator over the guide pin and the first dilator is illustrated in FIGS. 3 and 5 by placement of the second dilator 22 over the guide pm 1 and the first dilator 1 1. The term successive as used herein may include placing only one additional dilator or more than one additional dilators. Successive placement of two additional dilators over the guide pin and the first dilator is illustrated in FIGS. 12 and 13 by placement of the second dilator 22 and the third dilator 33 over the guide pin I and the first dilator 11. Each of the successively placed additional dilators (22, 33) illustrated is shown moved toward the femur 510 to successively move soft tissue away from the guide pin 1 .

[00042] Method embodiments also include placing a working cannula over the guide pm and all of the dilators placed over the guide pin and moving the working cannula toward the hone to move soft tissue away from the guide pin. For example, the working cannula 40 is shown placed over the guide pin 1, the first dilator 1 1, and the second dilator 22 in FIG. 5. Here the working cannula 40 is shown after being moved toward the femur 510 to move soft tissue (not shown) away from the guide pin 1. In FIG. 13, the working cannula 50 is shown placed over the guide pin 1, the first dilator 1 1, the second dilator 22, and the third dilator 33. The working cannula 50 is shown after being moved toward the femur 10 to move soft tissue (not shown) away from the guide pin 1.

[00043] Some embodiments may also include coupling a handle to the working cannula near a proximal end of the working cannula to provide an extension to the working cannula that may be grasped by a user of the working cannula prior to the act of placing a working cannula over the guide pin and all of the dilators placed over the guide pm and moving the working cannula toward the bone to move soft tissue away from the guide pin. For example, the handle 60 (FIGS. 6 and 7) may be coupled to the working cannula 40 or the working cannula 50 by inserting a connector 67 at a distal end of the handle 60 within the opening 47 or the opening 57 respectively. The handle 60 thereby provides an extension respectively to either working cannula 40, 50 that may be grasped by a user.

[00044] Some method embodiments may include inserting one or more fixation pins through one or more fixation pin holes and into the bone to secure the working cannula relative to the bone. With reference to the working cannulas 40, 50, fixation pins 45 (FIGS. 7, 8, 10, and 14) may respectively be placed in the fixation pin holes 44 (FIG. 4, 5, and 7) or fixation pin holes 54 (FIG. 13) to secure the working cannula 40, 50 relative to the femur 510. In some embodiments, the act of inserting fixation pins may include inserting two or more fixation pins that are not parallel with each other. For example, two or more of the fixation pins 45 shown in FIG. 8 that have been inserted into the fixation pin holes 44 are not substantially parallel to one another. Similarly, two or more of the fixation pins 45 shown in FIG. 14 that have been inserted into the fixation pin holes 54 are not substantially parallel to one another. The act of placing a working cannula 40, 50 as illustrated, includes placing the working cannula 40, 50 with a flange 42, 52 near its respective proximal end that is substantially perpendicular to a longitudinal axis of the working cannula 40, 50. The flange 42, 52 includes the one or more fixation pin holes 44, 54, but in other embodiments, fixation pin holes are not necessarily through a flange as illustrated. [00045] Method embodiments may also include removing all of the dilators placed over the guide pin by mo ving the dilators away from the bone and over the guide pm, thereby leaving the guide pin in the bone and the working cannula near the bone to provide a working channel through which a graft tunnel may be created. As shown in FIGS. 8 and 10, the first dilator 11 and the second dilator 22 have been removed over the guide pin 1 by moving the dilators 11, 22 away from the femur 510. As shown in FIG. 14, the first dilator 11, the second dilator 22, and the third dilator 33 have been removed over the guide pin 1 by moving the dilators 11, 22, 33 away from the femur 510.

[00046] Method embodiments may include placing a cannulated hole creation instrument over the guide pin and moving the hole creation instrument over the guide pin and into the bone to create the graft tunnel along a trajectory of the guide pin. For example, with reference to FIGS. 8 and 9, a cannulated hole creation instrument 70 in the fonn of a cannulated reamer is placed over the guide pin 1 and moved into the femur 510. By this action, the graft tunnel 515 is created in the femur 510 along the trajectory of the guide pin 1. A similar graft tunnel may be created in the same way over guide pin 1 in the embodiment of FIGS. 12-15. Hole creation instruments of other embodiments may be any effective device for creating a hole or tunnel in bone, including but not limited to a cannulated drill bit.

[Θ0047] Some method embodiments also include passing a ligament through the graft tunnel and coupling the ligament to the bone by coupling an interference screw within the graft tunnel. An example of such an embodiment may include passing an anterior cruciate ligament through the graft tunnel 515 and coupling the anterior cruciate ligament to the femur 510 with an interference screw (not shown) within the graft tunnel 515. Any effective interference screw or other effective structure may be used with these embodiments. Another embodiment may include passing an anterior cruciate ligament through the graft tunnel 515 and coupling the anterior cniciate ligament to the femur 510 by coupling a button to the anterior cruciate ligament to restrict the movement of the anterior cruciate ligament in the graft tunnel 515. A button of some embodiments is an XTENDOBUTTON brand fixation device, manufacture by Smith & Nephew, used in conjunction with any Smith & Nephew ENDOBUTTON brand fixation device. This combination of devices allows a 6 mm to 10 mm area of a femoral tunnel, such as the femoral tunnel 515 to be covered by the fixation devices. Any other effective fixation device or combination of devices may be used in other embodiments.

[00048] An embodiment of the invention is an instrument set having a guide pin configured to be inserted through a patient's soft tissue in a first direction and to dock with a bone in which a graft tunnel is to be created, a first dilator sized to fit over and be guided along the guide pin and move the patient's soft tissue away from the guide pin, a working cannula sized to fit over and be guided in the first direction of the guide pin, toward the bone, and move the patient's soft tissue away from die guide pin, wherein the working cannula provides a working channel through which the graft tunnel may be created, and a cannulated hole creation instrument configured to fit over and be guided along the guide pin to create the graft tunnel along a trajectory of the guide pin.

[Θ0049] The working cannula may include one or more fixation pin holes through which fixation pins may be placed into the bone to secure the working cannula relative to the bone. The one or more fixation pin holes may include two or more fixation pin holes that are not substantially parallel with each other. The working cannula may include a flange near its proximal end that is substantially perpendicular to a longitudinal axis of the working cannula. The flange may include one or more fixation pin holes through which fixation pins may be placed into the bone to secure the working cannula relative to the bone. The one or more fixation pin holes may include two or more fixation pin holes that are not substantially parallel with each other. The cannulated hole creation instrument may be a cannulated reamer configured to fit over and be guided along the guide pin to create the graft tunnel along a trajectory of the guide pin. The cannulated hole creation instalment may be a cannulated drill bit configured to fit over and be guided along the guide pin to create the graft tunnel along a trajectory of the guide pin. The instrument set may also include a second dilator configured to fit over the first dilator and move the patient's soft tissue away from the guide pin as the second dilator is moved toward the bone, wherein the second dilator is sized to fit within the working cannula. The instrument set may also include a third dilator configured to fit over the second dilator and move the patient's soft tissue away from the guide pm as the third dilator is moved toward the bone, wherein the third dilator is sized to fit within the working cannula. The instrument set may also include fixation pins sized and configured to secure the working cannula relative to the bone. The instalment set may also include a handle configured to couple with the working cannula near a proximal end of the working cannula and provide an extension to the working cannula that may be grasped by a user of the working cannula.

[00050] Another embodiment of the invention is a working cannula through which a graft tunnel may be created in a bone near a distal end of the working cannula, wherem the working cannula includes one or more fixation pin holes through which fixation pins may be placed into the bone to secure the working cannula relative to the bone. The one or more fixation pin holes may include two or more fixation pin holes that are not substantially parallel with each other. The working cannula may include a flange near its proximal end that is substantially perpendicular to a longitudinal axis of the working cannula. The flange may include one or more fixation pin holes through which fixation pins may be placed into the bone to secure the working cannula relative to the bone . The one or more fixation pin holes may include two or more fixation pin holes that are not substantially parallel with each other. The working cannula may also include a handle configured to couple with the working cannula near a proximal end of the working cannula and provide an extension to the w orking cannula that may be grasped by a user of the working cannula.

[00051] Various embodiments of a system wholly or its 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 oilier effective material. Examples of biocompatible polymer materials include polyamide base resins, polyethylene, Ultra High Molecular Weight (UHMW) polyethylene, low density polyethylene, polymethylmethacrylate (PMMA), polyetheretherketone (PEEK), polyetherketoneketone (PEKK), a polymeric hy droxyetliyiniethacrylate (PHEMA), and poiy urethane, any of which may be reinforced. Polymers used as bearing surfaces in particular may in whole or in part include one or more of cross-linked and highly cross-linked polyethylene. 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.

[00052] Terms such as distal, proximal, away, near, over, 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.

[00053] While embodiments of the invention 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 invention are to be considered within the scope of the disclosure.

Claims

Embodiments of the invention may include claims to:

1. A method of soft tissue repair comprising:

inserting a guide pin through skin and into a bone to which soft tissue is to be attached;

placing a first dilator sized to fit over and be guided along the guide pin over the guide pin and moving the first dilator toward the bone to move soft tissue away from the guide pin;

successively placing one or more additional dilators over the guide pin and the fi rst dilator and moving the one or more additional dilators toward the bone to successively move soft tissue away from the guide pin;

placing a working cannula over the guide pin and all of the dilators placed over the guide pm and moving the working cannula toward the bone to move soft tissue away from the guide pin;

removing all of the dilators placed over the guide pin by moving the dilators away from the bone and over the guide pm, tliereby leaving the guide pin in the bone and the working cannula near the bone to provide a working channel through which a graft tunnel may be created; and

placing a cannulaied hole creation instrument over the guide pin and moving the hole creation instalment over the guide pin and into the bone to create the graft tunnel along a trajectory of the guide pin.

2. The method of claim 1 wherein the soft tissue being repaired includes an anterior cruciate ligament.

3. The method of claim 1 wherein the act of inserting the guide pin into a bone includes inserting the guide pm into a femur.

4. The method of claim 1 wherein the act of inserting the guide pin includes orienting the guide pin in a direction that is a desirable trajectory for the graft tunnel.

5. The method of claim 4 wherein the act of orienting the guide pin is accomplished under imaging of the guide pm and bone.

6. The method of claim I, further comprising coupling a handle to the working cannula near a proximal end of the working cannula to provide an extension to the working cannula that may be grasped by a user of the working cannula prior to the act of placing a working cannula over the guide pin and all of the dilators placed over the guide pm and moving the working cannula toward the bone to move soft tissue away from the guide pin.

7. The method of claim 1, further comprising inserting one or more fixation pins in one or more fixation pin holes and into the bone to secure the working cannula relative to the bone,

8. The method of claim 7 wherein the act of inserting one or more fixation pins includes inserting two or more tixation pins that are not substantially parallel with each other after insertion.

9. The method of claim 1 wherein the act of placing a working cannula includes placing a working cannula with a flange near its proximal end that is substantially perpendicular to a longitudinal axis of the working cannula.

10. The method of claim 9, further comprising inserting one or more fixation pins through one or more fixation pin holes in the flange and into the bone to secure the working cannula relative to the bone.

1 . The method of claim 10 wherein the act of inserting one or more fixation pins through one or more tixation pin holes in the flange includes inserting the one or more fixation pins into two or more fixation pin holes that are not substantially parallel with each other after insertion.

12. The method of claim 1 wherein the act of placing a cannulated hole creation instrument includes placing a cannulated drill bit.

13. The method of claim 1 wherein the act of placing a cannulated hole creation instrument includes placing a cannulated reamer.

14. The method of claim 1, furtlier comprising passing a ligament through the graft, tunnel and coupling the ligament to the bone by coupling an interference screw within the graft, tunnel.

15. The method of claim 1, further comprising passing a ligament through the graft tunnel and coupling the ligament to the bone by coupling a button to the ligament to restrict the movement of the ligament in the graft tunnel.