Tenodesis implant and inserter and methods for using same
The present invention provides a novel split barbed fixation device for tenodesis, soft tissue reattachment of tendons and ligaments to bones. The insertion device is adapted for an entirely arthroscopic approach while achieving fixation strength with ultimate pullout resistance comparable to interference screws. The device includes an integrated tendon grasper that provides for easy manipulation of the tendon arthroscopically while eliminating the need for external whip stitching of the tendon, thereby reducing preparation time. The device further includes elements that prevent the fixation implant from being destabilized or rotating during deployment and manipulation, including: a depth limiting sheath, a first implant retainer, a first implant retaining step, a tendon grasping needle tube, and an implant keyway for mating the implant to the tube. The implant itself comprises two separate portions mating along a diagonal and having barbed surface features in opposite directions, only one of which contacts the tendon.
1. A system for arthroscopic tenodesis repair, comprising:
a first implant movable distally into a procedural site;
a second implant mateable with said first implant and also movable distally into the procedural site;
a tendon grasper movable distally to extend through and capture a tendon to be re-attached to bone at the procedural site; and
a first implant retainer, said first implant retainer comprising a member extendable outwardly from the tendon grasper for engaging the first implant and retaining it in axial position relative to the tendon grasper while the second implant is moved distally;
wherein said tendon grasper comprises a distal portion for piercing a tendon and a tendon grasping needle tube which is axially movable relative to the distal portion and houses the distal portion therein, wherein the outwardly extendable member of the first implant retainer extends from and retracts into the tendon grasping needle tube;
wherein said tendon grasping needle tube further comprises an implant keyway for mating the first implant and the second implant to said tendon grasping needle tube, thereby preventing rotation of the implants during deployment and manipulation.
2. The system as recited in claim 1 , and further comprising a notch on said first implant for engaging the outwardly extendable member of the first implant retainer.
3. The system as recited in claim 1 , wherein the tendon grasper further comprises an outwardly movable member for securing the tendon to the tendon grasper.
4. The system as recited in claim 1 , and further comprising a proximal handle portion, the handle portion comprising:
a mallet knob at a proximal end of the handle which is axially movable relative to the handle; and
a retaining pin which is removably placeable in said handle to prevent relative movement of the mallet knob and the handle.
5. The system as recited in claim 4 , and further comprising an actuator for extending and retracting the outwardly movable member of the first implant retainer.
6. The system as recited in claim 5 , wherein said actuator further functions to extend and retract an outwardly movable member on said tendon grasper.
7. The system as recited in claim 1 , and further comprising a depth limiting sheath, said depth limiting sheath comprising structure for contacting bone to prevent further distal deployment of the first implant into the procedural site.