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.

1 .- 19 . (canceled) 
     
     
         20 . A method of deploying a fixation implant in a tunnel formed in a bone, comprising:
 positioning a fixation implant retained on a distal end of an insertion tool in a tunnel formed in a bone, the fixation implant, comprising:
 an implant body having a distal end, a proximal end, and a longitudinal axis; 
 a first arm on the implant body, the first arm located at the distal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for engaging a wall in the tunnel for implanting the implant body in the tunnel; and 
 a first compression pad on the implant body, the first compression pad located at the proximal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for moving soft tissue that is situated between the first compression pad and the wall in the tunnel away from the longitudinal axis of the implant body for compressing the soft tissue against bone in the tunnel; and 
   rotating a knob of the insertion tool relative to a handle portion of the insertion tool, wherein said rotating causes a rotatable element that is linked to the knob through the insertion tool to rotate relative to the longitudinal axis of the implant body, the rotatable element extending longitudinally through the implant body to engage a wedge disposed in the distal end of the implant body such that rotating the rotatable element: (a) moves the wedge in a proximal direction inside the implant body so that the wedge contacts the first arm and forces the first arm to deploy outwardly relative to the longitudinal axis of the implant body; and (b) moves a proximal deployment element that is located proximally of the wedge inside the implant body in a distal direction so that the proximal deployment element contacts the first compression pad and forces the first compression pad to deploy outwardly relative to the longitudinal axis of the implant body.   
     
     
         21 . The implanting system of  claim 20  further comprising disengaging a safety pin from the handle portion prior to said rotating, wherein the safety pin, prior to said disengaging, prevents said rotating. 
     
     
         22 . The implanting system of  claim 20 , wherein the insertion tool allows for rotation of the rotatable element in only one direction relative to the longitudinal axis of the implant body when the rotatable element is extending longitudinally through the implant body. 
     
     
         23 . The implanting system of  claim 20  further comprising coupling a soft tissue graft to the fixation implant. 
     
     
         24 . The implanting system of  claim 23  further comprising securing a suture attached to the soft tissue graft to a suture cleat on the insertion tool. 
     
     
         25 . The implanting system of  claim 20 , wherein said rotating is performed until the knob contacts the handle portion of the insertion tool. 
     
     
         26 . The implanting system of  claim 20 , wherein the fixation implant further comprises a second arm on the implant body, the second arm being located at the distal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for engaging the wall in the tunnel for implanting the implant body in the tunnel. 
     
     
         27 . The implanting system of  claim 26 , wherein the second arm is separated from the first arm on the implant body. 
     
     
         28 . The implanting system of  claim 20 , wherein the fixation implant further comprises a second compression pad on the implant body, the second compression pad being located at the proximal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for moving soft tissue that is situated between the first compression pad and the wall in the tunnel away from the longitudinal axis of the implant body for compressing the soft tissue against bone in the tunnel. 
     
     
         29 . The implanting system of  claim 28 , wherein the second compression pad is separated from the first compression pad on the implant body. 
     
     
         30 . The implanting system of  claim 20 , wherein the implant body has a longitudinal passage extending from the proximal end to the distal end of the implant body, the wedge and the proximal deployment element positioned in the longitudinal passage. 
     
     
         31 . The implanting system of  claim 20 , wherein the implant body is sized for deployment through a 5-8 mm cannula. 
     
     
         32 . A method of deploying a fixation implant in a tunnel formed in a bone, comprising:
 positioning a fixation implant retained on a distal end of an insertion tool in a tunnel formed in a bone, the fixation implant, comprising:
 an implant body having a distal end, a proximal end, and a longitudinal axis; 
 a first arm on the implant body, the first arm located at the distal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for engaging a wall in the tunnel for implanting the implant body in the tunnel; and 
 a first compression pad on the implant body, the first compression pad located at the proximal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for moving soft tissue that is situated between the first compression pad and the wall in the tunnel away from the longitudinal axis of the implant body for compressing the soft tissue against bone in the tunnel; 
   actuating a deployment system that extends longitudinally through the implant body, wherein said actuating: (a) moves a distal deployment element of the deployment system in a proximal direction inside the implant body so that the distal deployment element contacts the first arm and forces the first arm to deploy outwardly relative to the longitudinal axis of the implant body; and (b) moves a proximal deployment element of the deployment system in a distal direction inside the implant body so that the proximal deployment element contacts the first compression pad and forces the first compression pad to deploy outwardly relative to the longitudinal axis of the implant body; and   disengaging a safety pin from a handle portion of the insertion tool prior to said actuating, wherein the safety pin, prior to said disengaging, prevents said actuating.   
     
     
         33 . The implanting system of  claim 32 , wherein the distal deployment element comprises a wedge. 
     
     
         34 . The implanting system of  claim 32 , wherein the implant body is sized for deployment through a 5-8 mm cannula. 
     
     
         35 . The implanting system of  claim 32 , wherein the fixation implant further comprises a second arm on the implant body, the second arm being located at the distal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for engaging the wall in the tunnel for implanting the implant body in the tunnel. 
     
     
         36 . The implanting system of  claim 35 , wherein the second arm is separated from the first arm on the implant body. 
     
     
         37 . The implanting system of  claim 32 , wherein the fixation implant further comprises a second compression pad on the implant body, the second compression pad being located at the proximal end of the implant body and being outwardly deployable relative to the longitudinal axis of the implant body for moving soft tissue that is situated between the first compression pad and the wall in the tunnel away from the longitudinal axis of the implant body for compressing the soft tissue against bone in the tunnel. 
     
     
         38 . The implanting system of  claim 37 , wherein the second compression pad is separated from the first compression pad on the implant body. 
     
     
         39 . The implanting system of  claim 32 , wherein the implant body has a longitudinal passage extending from the proximal end to the distal end of the implant body, the distal deployment element and the proximal deployment element positioned in the longitudinal passage.