Biologic Intramedullary Fixation Device and Methods of Use

Abstract

A biologic intramedullary fixation device for treating a bone fracture includes an internal tubular wall formed of a bioabsorbable synthetic material; and an outer wall coupled with and surrounding the internal tubular wall with an annular space therebetween. The outer wall is at least partially fenestrated and is formed of the bioabsorbable synthetic material. A biologically replaceable cement material is injectable into the annular space between the internal tubular wall and the outer wall.

1 . A biologic intramedullary fixation device for treating a bone fracture, the device comprising:
 an internal tubular wall formed of a bioabsorbable synthetic material;   an outer wall coupled with and surrounding the internal tubular wall with an annular space therebetween, the outer wall being at least partially fenestrated and being formed of the bioabsorbable synthetic material;   inter-wall connectors connecting the internal tubular wall and the outer wall; and   a biologically replaceable cement material injectable into the annular space between the internal tubular wall and the outer wall, wherein the outer wall is structured to permit penetration of biologically replaceable cement material injected into the annular space through the outer wall to the bone fracture, and wherein the cement comprises a viscosity such that the cement can penetrate the area adjacent the bone fracture through the fenestrations in the outer wall.   
     
     
         2 . A biologic intramedullary fixation device according to  claim 1 , wherein the internal tubular wall is partially fenestrated adjacent the bone fracture. 
     
     
         3 . A biologic intramedullary fixation device according to  claim 1 , wherein the internal tubular wall defines an internal cavity, and wherein a top of the internal cavity is sealed with a set screw. 
     
     
         4 . A biologic intramedullary fixation device according to  claim 3 , wherein a bottom of the internal tubular cavity is left open to allow in-growth of vessels and resorption of the device. 
     
     
         5 . A biologic intramedullary fixation device according to  claim 1 , wherein the internal tubular wall is ribbed. 
     
     
         6 . A biologic intramedullary fixation device according to  claim 1 , wherein the outer wall is fenestrated except for its proximal and distal ends. 
     
     
         7 . A biologic intramedullary fixation device according to  claim 1 , wherein the fenestrations in the outer wall are more prominent adjacent the bone fracture. 
     
     
         8 . A biologic intramedullary fixation device according to  claim 1 , wherein the inter-wall connectors are integral with the internal tubular wall and the outer wall. 
     
     
         9 . A biologic intramedullary fixation device according to  claim 1 , wherein the internal tubular wall and the outer wall are integral. 
     
     
         10 . A biologic intramedullary fixation device for treating a bone fracture, the device comprising:
 an internal tubular wall formed of a bioabsorbable synthetic material;   an outer wall coupled with and surrounding the internal tubular wall with an annular space therebetween, the outer wall being at least partially fenestrated and being formed of the bioabsorbable synthetic material;   inter-wall connectors connecting the internal tubular wall and the outer wall, wherein the inter-wall connectors have a length spanning substantially an entire length of the device; and   a biologically replaceable cement material injectable into the annular space between the internal tubular wall and the outer wall, wherein the outer wall is structured to permit penetration of biologically replaceable cement material injected into the annular space through the outer wall to the bone fracture.   
     
     
         11 . A method of treating a bone fracture using a biologic intramedullary fixation device including an internal tubular wall formed of a bioabsorbable synthetic material, and an outer wall coupled with and surrounding the internal tubular wall with an annular space therebetween, the outer wall being at least partially fenestrated and being formed of the bioabsorbable synthetic material, the method comprising:
 (a) forming a cavity in the bone that extends across the bone fracture;   (b) inserting the biologic intramedullary fixation device in the cavity; and   (c) after step (b), injecting a biologically replaceable cement material into the annular space between the internal tubular wall and the outer wall without injecting the biologically replaceable cement material within the internal tubular wall, wherein the biologically replaceable cement material penetrates the area adjacent the bone fracture through the fenestrations in the outer wall.   
     
     
         12 . A method according to  claim 11 , further comprising, after step (c), inserting a set screw in an end of the internal tubular wall and covering the annular space.