Systems and methods for sizing and introduction of soft-tissue allografts

Abstract

The present disclosure includes systems, methods, kits, and individual tools (e.g., trial sizers and delivery devices) for medical procedures involving a soft-tissue allograft for the correction of skeletal impairments (e.g., misalignments, arthritis, etc.).

1 - 20 . (canceled) 
     
     
         21 . A method for delivering an implant, the method comprising:
 (a) inserting a trial sizer into a given space between bones of a patient;   (b) determining whether the trial sizer fits into the space in an acceptable way, and:
 (i) if the trial sizer fits into the space in an acceptable way, delivering the implant to the space; or 
 (ii) if the trial sizer does not fit into the space in an acceptable way, sequentially repeating steps (a) and (b) with a trial sizer of a different size until a trial sizer fits into the space in an acceptable way. 
   
     
     
         22 . The method of  claim 21 , further comprising excising a bone in a patient prior to inserting the trial sizer. 
     
     
         23 . The method of  claim 22 , wherein the bone is a trapezium bone. 
     
     
         24 . The method of  claim 21 , wherein the space between bones is the space occupied by the trapezium bone in the carpometacarpal joint. 
     
     
         25 . The method of  claim 21 , wherein a peripheral surface of a head of the trial sizer faces bone. 
     
     
         26 . The method of  claim 25 , wherein a first side and a second side of the head of the trial sizer faces bone. 
     
     
         27 . The method of  claim 21 , wherein delivering the implant to the space comprises using a suture delivery guide. 
     
     
         28 . The method of  claim 27 , wherein the suture delivery guide comprises:
 a body having a first side and a second side and defining an implant chamber extending through the first side toward the second side, the body defining a plurality of first suture passages on a first side of the implant chamber and a plurality of second suture passages on a second side of the implant chamber, each of the second suture passages being aligned with a corresponding one of the first suture passages, the body further defining a first slot extending through the first side of the body and in fluid communication with all of the first suture passages, and a second slot extending through the first side of the body and in fluid communication with all of the second suture passages.   
     
     
         29 . The method of  claim 21 , wherein delivering the implant to the space comprises:
 (a) passing a suture through the implant and looping the suture through a flexor carpi radialis tendon;   (b) looping the suture back through a soft-tissue allograft;   (c) delivering the allograft over the suture and into the space between bones of the patient; and   (d) tying the suture using an acceptable surgical knot.   
     
     
         30 . The method of  claim 21 , further comprising inserting a delivery cannula into the space. 
     
     
         31 . The method of  claim 30 , further comprising:
 after delivering the soft-tissue allograft, removing the delivery cannula.   
     
     
         32 . The method of  claim 31 , where the delivery cannula comprises an elongated body having a proximal end and a distal end, and defining a longitudinal channel extending between, and through, the proximal end and the distal end, and a handle portion coupled to the proximal end of the elongated body, the handle portion defining a channel that is aligned with and in fluid communication with the longitudinal channel of the elongated body. 
     
     
         33 . The method of  claim 21 , wherein the trial sizer is selected from a kit having more than one trial sizers. 
     
     
         34 . The method of  claim 21 , further comprising inserting a suture anchor into a first bone. 
     
     
         35 . The method of  claim 34 , wherein the first bone is a second metacarpal. 
     
     
         36 . The method of  claim 34 , wherein the suture anchor is inserted into a distal aspect of the first bone. 
     
     
         37 . The method of  claim 34 , further comprising fastening a soft-tissue allograft to the suture anchor. 
     
     
         38 . A method for delivering an allograft, the method comprising:
 providing at least one sterile pre-formed soft-tissue allograft rod plug, the pre-formed soft-tissue allograft rod plug being resiliently compressible;   delivering the at least one sterile pre-formed soft-tissue allograft rod plug into the space between a set of bones of the patient.   
     
     
         39 . The method of  claim 38 , wherein the pre-formed allograft rod plug has a diameter about equal to an average width of a space between a person's bones and a density sufficient to resist full compression of the space. 
     
     
         40 . The method of  claim 38 , wherein the pre-formed allograft rod plug is resiliently compressible and flexible while remaining substantially as the formed plug. 
     
     
         41 . The method of  claim 38 , wherein the space between bones is the space occupied by the trapezium bone in the carpometacarpal joint.