# Patent

## Title
Inserter for soft tissue or bone-to-bone fixation device and methods

## Abstract

A positioning and installation tool for a fixation implant is inserted through a single, simple drill hole and positioned in place. The device controls the degree to which the implant is deployed and prevents accidental disengagement of the device from the implant before deployment has completed. The device also guides the components of the implant involved in active tendon compression at the aperture of the bone tunnel. The implant is deployed simply by rotating a knob, thereby creating an anchor point of high stiffness and fixation strength. When deployment has completed, the inserter is disengaged from the affixed implant by simply pulling a release mechanism.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional application under 35 U.S.C. 120 of commonly assigned U.S. patent application Ser. No. 12/437,007 entitled Inserter for Soft Tissue or Bone-to-Bone Fixation Device and Methods, filed on May 7, 2009, issued as U.S. Pat. No. 8,858,565 on Oct. 14, 2014, which in turn claims the benefit under 35 U.S.C. 119(e) of the filing date of Provisional U.S. Application Ser. No. 61/051,671, entitled Inserter for Soft Tissue or Bone-to-Bone Fixation Device, filed on May 8, 2008. Each of the above referenced applications are expressly incorporated herein by reference, in their entirety.


BACKGROUND OF THE INVENTION
The present invention relates generally to devices, systems and methods for material fixation, and, more particularly, to insertion devices for fixation implants utilized to attach soft tissue to bone, for the purpose of the repair of many soft tissue injuries, such as in the reconstruction of the Anterior Cruciate Ligament (ACL).
SUMMARY OF THE INVENTION
The disclosed invention is an inserter, intended to be used in conjunction with a soft tissue or bone-to-bone fixation device that will allow a surgeon to repair many soft tissue injuries, such as an Anterior Cruciate Ligament (ACL) injury. The bone-to-bone fixation device, once loaded with a soft tissue graft, is deployed into a prepared bone tunnel using the invention described herein. The fixation implant is packaged sterile and preloaded onto the inserter. In a preferred embodiment, the disclosed inserter device may be utilized with a fixation implant of the type disclosed in commonly assigned U.S. patent application Ser. No. 11/923,526 (the '526 application), entitled Methods and Systems for Material Fixation, filed on Oct. 24, 2007, and herein expressly incorporated by reference in its entirety.
Current ACL repairs may be difficult to perform, require more steps, additional procedure time, extra drilling, external jigs or fixtures or multiple assistants. The device is an easy to use positioning and installation tool for a femoral implant of the type disclosed in the '526 application. The device is inserted through a single, simple drill hole and positioned into place. The device controls the degree to which the implant is deployed and prevents accidental disengagement from the implant before deployment has completed. The device also guides the components of the implant involved in active tendon compression at the aperture of the femoral tunnel. The implant is deployed simply by rotating a knob, thereby creating a femoral anchor point of high stiffness and fixation strength. When deployment has completed, the inserter is disengaged from the affixed implant by simply pulling a release mechanism.
The use of the device is straightforward, eliminating potential for confusion that may arise when using other femoral fixation technologies. No additional accessories or steps are required. The only required step in preparation for fixation is to locate and drill a single tunnel within the femur. The device is designed to be used by a single operator to minimize the time and cost required to perform the procedure.
More particularly, there is provided a device for positioning and deploying a fixation implant, which comprises a handle, an insertion shaft extending distally from the handle, an implant retention mechanism disposed on a distal end of the insertion shaft, an implant deployment control disposed on the handle, and an implant release control disposed on the handle. A suture cleat is also preferably disposed on the handle, on which suture may be wrapped. A safety mechanism is disposed on the device for preventing unintentional actuation of the deployment control. Preferably, the deployment control comprises a rotatable knob and the safety mechanism comprises a safety pin which is removable to permit rotation of the rotatable deployment knob.
The inventive insertion device further comprises a mechanism for limiting rotation of the deployment knob to only one direction, wherein because the deployment knob may only be rotated in one direction, the deployment knob may be advanced distally, but not retracted proximally. The implant retention mechanism comprises a ball detent mechanism. The ball detent mechanism comprises a detent ball, a detent ball retainer, and a ball detent rod. An insertion shaft spring is disposed on the ball detent rod.
The fixation implant comprises an implant screw for deploying the fixation implant. The implant screw comprises a head having a hole for engaging the detent ball. The implant release control comprises a knob which is movable proximally to disengage the implant retention mechanism from a fixation implant engaged therewith. A hex tube is disposed at the distal end of the insertion shaft. The implant retention mechanism is disposed on the hex tube and the hex tube has a recess for receiving a portion of the fixation implant.
The implant screw further comprises internal left-hand threads disposed on an interior surface in the head, defining the hole, so that the implant screw may be disengaged from the fixation implant. A shaft having external threads extends distally from the implant screw head.
In another aspect of the invention, there is provided a fixation implant for securing soft tissue to bone or bone to bone, wherein the fixation implant comprises an implant screw for deploying the fixation implant. The implant screw comprises a head having a hole for engaging a detent ball forming part of an implant retention mechanism on an insertion tool. The implant screw further comprises internal left-hand threads disposed on an interior surface in the head, defining said hole, so that the implant screw may be disengaged from the fixation implant, and a shaft having external threads, extending distally from the head.
In still another aspect of the invention, there is disclosed a method for inserting a deployable fixation implant into an opening in bone. This method comprises steps of retaining the fixation implant on a distal end of an insertion tool, positioning the insertion tool in a desired bone opening, disengaging a safety mechanism so that a deployment control on the insertion tool may be actuated to deploy the fixation implant, and actuating the deployment control to advance of component of the fixation implant distally, so that portions of the fixation implant are expanded radially to engage adjacent bone. The disengaging step comprises removing a safety pin from the insertion tool to thereby permit rotation of the deployment control, and the actuation step comprises rotating a knob of the deployment control. The inventive method further comprises a step of releasing the fixation implant from the insertion tool.
The invention, together with additional features and advantages thereof, may best be understood by reference to the following description taken in conjunction with the accompanying illustrative drawing.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a plan view of an insertion device constructed in accordance with the principles of the present invention;
FIG. 2 is an exploded view of the insertion device illustrated in FIG. 1;
FIG. 3 is a plan view of the insertion device of FIGS. 1 and 2 as it is being utilized for deploying an implant into a bone tunnel;
FIG. 4A is a plan view of an implant screw which forms a part of the implant being deployed, utilized on conjunction with the insertion device of FIGS. 1-3 for deploying an implant;
FIG. 4B is a perspective view of the implant screw shown in FIG. 4A; and
FIG. 4C is a cross-sectional view of the implant screw of FIG. 4B, taken along line 4C-4C.



DESCRIPTION OF THE PREFERRED EMBODIMENT
The device 10 of the present invention is an inserter, used for positioning and deployment of a fixation implant like that described in the '526 application. The user interface features of the inserter 10, depicted in FIG. 1, are a handle 12, a safety pin 14, an insertion shaft 16, a deployment knob 18, a release knob 20, and suture cleats 22.
At the end of the insertion device 10, a sutured soft tissue graft (not shown) is loaded onto the implant (not shown), and the free suture strands (not shown) are secured to the suture cleats 22 to allow for suture management and easy insertion of the graft complex. The suture cleats 22 are designed to be easily and quickly wrapped with suture. After the suture has been attached to the cleats, the inserter is placed inside a femoral tunnel 24 in the femur 26 of a patient (FIG. 3). When it has reached the desired deployment location, the inserter and implant are deployed. Deployment is performed by removing the safety pin 14 and rotating the deployment knob 18 in a clockwise fashion until the deployment knob 18 comes into contact with the inserter handle 12, or until it can no longer be turned. An implant (not shown) is attached to the tip of the insertion shaft 16 by means of a ball detent mechanism (FIG. 2), comprising a detent ball 28, a detent ball retainer 30, and a ball detent rod 32, on which is disposed an insertion shaft spring 34. The ball detent mechanism engages with a hole 36 (FIG. 4A, 4B, 4C) in an implant screw 38. Deployment motion of the inserter 10 is ratcheted and is limited to the clockwise direction to prevent accidental undeployment. By rotating the deployment knob 18, the diamond wedge of the implant expands the implant arms outward, which provide fixation by engaging against the wall of the femoral tunnel 24. To disengage the implant from the inserter 10, the implant release knob 20 is pulled, releasing the detent mechanism. The insertion device can then be removed from the soft tissue graft implant site after any suture has been detached from the suture cleats 22.
The device may come preloaded with the fixation implant attached to the inserter tip 40 (FIG. 3). FIGS. 4A-4C show the implant screw 38, held to a hex tube 42 of the inserter 10 by means of the aforementioned ball detent mechanism and hole 36 in the implant screw. The head 44 of the implant screw 38 has internal left hand threads 46 (FIG. 4C) in order to remove the screw if a revision of the implant should be necessary. To remove the screw, a left-hand threaded removal tool is screwed into the hex head 44 of the screw, securing the screw to the removal tool. The tool is then rotated in a counterclockwise direction to unscrew and disengage the screw from the implant.
Now referring more particularly to FIG. 2, a threaded ratchet shaft 48 has a multitude of cuts running parallel to its length, designed to engage a pawl 50, limiting its rotation to the clockwise direction. The pawl 50 is fitted over a pawl axle 52 which rests inside a mated cavity in a handle bottom 54. As the threaded ratchet shaft 48 rotates clockwise, the pawl 50 is deflected downwards towards the handle bottom 54. When the pawl 50 comes into contact with one of the cuts in the threaded ratchet shaft 48, it is returned to the engaging antirotation position by a torsion spring 56. If motion is attempted in the counterclockwise direction, the flat face of the cutout in the threaded ratchet shaft 48 engages the flat face of the pawl 50, preventing antirotation. A leaf spring may be substituted for the pawl 50 and torsion spring 56 if it is positioned such that it engages the flat face of the threaded ratchet shaft 48.
The deployment knob 18 may be attached to the threaded ratchet shaft 48 by means of an alignment pin 58. As the deployment knob 18 rotates the threaded ratchet shaft 48 in a clockwise direction, it is translated linearly forward by a stationary translation nut 60. The translation nut 60 is fitted inside a cavity in the handle bottom 54 and the handle top 62. The deployment tube 64, which engages with and turns the implant screw, is affixed to the threaded ratchet shaft 48. The threaded ratchet shaft 48 and implant screw are threaded so that the turn to travel ratio are 1:1 between the two components. Therefore, as the threaded ratchet shaft 48 and deployment tube 64 rotate, the per-turn linear travel of the threaded ratchet shaft 48 is equal to the linear travel of the implant screw within the implant body.
The inserter tip 40 interfaces with the compression pads on the femoral implant to prevent implant rotation and assists in aligning and guiding the compression pads as they separate. The insertion shaft 16 is preferably a hollow cylindrical collar that is allowed to freely slide over the deployment tube 64. An anti-rotation washer 66 has a machined groove that aligns to a longitudinal rib in the handle top 62. The anti-rotation washer has a positive spring bias created by the insertion shaft spring 34. The insertion shaft spring 34 is constrained by a rib within the handle top 62. As the assembly of the inserter tip 40, insertion shaft 16, and anti-rotation washer 66 moves distally during the course of implant deployment, the insertion shaft spring 34 compresses, providing a reaction force that ensures the inserter tip 40 remains engaged with the implant.
The deployment tube 64 contains a hollow cylindrical center portion that allows the ball detent rod 32 to slide freely within. The ball detent rod 32 also fits within the detent ball retainer 30 that is fixed inside the tip of the deployment tube 64. The purpose of the detent ball retainer 30 is to retain the detent ball 28 within the deployment tube 64 and to constrain its motion inwards and outwards from the engaging hex face of the deployment tube 64. The inside engaging hex face of the deployment tube 64 is drilled in such a manner that the detent ball 28 is prevented from falling out of the assembly yet is still allowed to protrude enough for significant engagement with the implant screw.
The detent ball 28 is sandwiched above the detent ball retainer 30 and below the engaging hex face of the deployment tube 64. As the ball detent rod 32 slides into the detent ball retainer 30, it pushes the detent ball 28 from the engaging hex face of the deployment tube 64. In this state, the detent ball 28 protrudes a distance out of the engaging hex face of the deployment tube 64 and is prevented from retracting back into the engaging hex face by the support of the ball detent rod 32 underneath.
The ball detent rod 32 is connected to a spring shaft 68 which is equipped with an engagement spring 70 that translates a positive engagement force to the ball detent rod 32. The engagement spring 70 is confined within the deployment knob 18 and a deployment knob cover 72 which it is compressed by when the spring shaft 68 is retracted.
It is to be understood that the figures of the bone and anchors seen above are purely illustrative in nature, and are not intended to limit the application of the inventive embodiments to any particular physiological application or purpose. The invention is applicable to many different types of procedures involving, in particular, the attachment of connective or soft tissue to bone. All of the terms used herein are descriptive rather than limiting, and many changes, modifications, and substitutions may be made by one having ordinary skill in the art without departing from the spirit and scope of the invention, which is to be limited only in accordance with the following claims.

## Claims

1. A method for inserting and deploying a deployable fixation implant into an opening in bone, said method comprising:
attaching and retaining the fixation implant on a distal end of a shaft of an insertion tool by engaging an implant retention mechanism disposed on the distal end of the shaft with a retaining feature disposed on the fixation implant;
positioning the fixation implant in the bone opening;
disengaging a safety mechanism from a handle of the insertion tool, the shaft extending distally from the handle;

actuating a deployment control knob extending from the handle of the insertion tool by rotating the deployment control knob relative to the handle to deploy the fixation implant in the bone opening, the safety mechanism including a safety pin which in an engaged position prevents rotation of the rotatable deployment control knob relative to the handle and in a disengaged position permits rotation of the deployment control knob relative to the handle, wherein during actuation of the deployment control knob a deployment mechanism, included in the handle, limits rotation of the deployment control knob relative to the handle to only one direction to advance the fixation implant distally into the bone opening, but prevent retraction of the fixation implant proximally out of the bone opening, so that portions of the fixation implant are expanded radially to engage adjacent bone in the bone opening;
actuating an implant release control knob extending from the handle of the insertion tool by moving the release control knob proximally relative to the handle to release the retention mechanism from engaging with the retaining feature of the fixation implant; and
withdrawing the insertion tool from the in-situ radially expanded fixation implant.

2. The method of claim 1, wherein the disengaging step comprises removing the safety pin from the insertion tool to thereby permit rotation of the deployment control knob.

3. The method of claim 1, wherein actuating the implant release control knob retracts the implant retention mechanism proximally.

4. The method of claim 1, wherein actuating the deployment control knob comprises rotating the deployment control knob until the deployment control knob contacts the handle of the insertion tool.

5. The method of claim 4, wherein the deployment control knob is rotated in a clockwise direction.

6. The method of claim 1, wherein the implant retention mechanism comprises a ball detent mechanism, the ball detent mechanism comprising a detent ball, a detent ball retainer, and a ball detent rod.

7. The method of claim 6, wherein the fixation implant comprises an implant screw including a head defining a hole for engaging the detent ball to retain the fixation implant on the distal end of the insertion tool.

8. The method of claim 1, further comprising a cleat coupled to the insertion tool and configured to receive one or more suture strands of a tissue graft.

9. The method of claim 1, wherein the implant retention mechanism is disposed on a hex tube at the distal end of the shaft of the insertion tool, and wherein attaching and retaining the fixation implant on the distal end of the shaft of the insertion tool comprises inserting a portion of the fixation implant into a recess of the hex tube.

10. A method for inserting and deploying a deployable fixation implant into an opening in bone, said method comprising:
attaching and retaining the fixation implant on a distal end of a shaft of an insertion tool by engaging an implant retention mechanism disposed on the distal end of the shaft with a retaining feature disposed on the fixation implant, the shaft extending distally from a handle of the insertion tool;
positioning the fixation implant in the bone opening;
disengaging a safety mechanism from the handle of the insertion tool, the safety mechanism including a safety pin which in an engaged position prevents rotation of a rotatable deployment control knob extending from the handle relative to the handle and in a disengaged position permits rotation of the deployment control knob relative to the handle;
rotating the deployment control knob relative to the handle to advance the fixation implant distally into the bone opening, wherein rotation of the deployment control knob is limited to only one direction by a deployment mechanism included in the handle to prevent proximal retraction of the fixation implant out of the bone opening; and
actuating an implant release control knob extending from the handle of the insertion tool by moving the implant release control knob proximally relative to the handle, wherein movement of the implant release control knob releases the implant retention mechanism from engagement with the retaining feature of the fixation implant.

11. The method of claim 10, wherein actuating the implant release control knob comprises pulling the implant release control knob in a proximal direction to disengage the fixation implant from the implant retention mechanism.

12. The method of claim 11, wherein the implant release control knob is proximal to and coaxial with the deployment control knob.

13. The method of claim 10, wherein the deployment control knob is rotated until the deployment control knob contacts the handle of the insertion tool.

14. The method of claim 10, wherein the implant retention mechanism comprises a ball detent mechanism, the ball detent mechanism comprising a detent ball, a detent ball retainer, and a ball detent rod.

15. The method of claim 14, wherein the fixation implant comprises an implant screw including a head defining a hole for engaging the detent ball to retain the fixation implant on the distal end of the shaft of the insertion tool.

16. The method of claim 10, further comprising a cleat coupled to the insertion tool and configured to receive one or more suture strands of a tissue graft.