Prosthetic surgical sling

Abstract

Disclosed is a process of making an expanded fluoropolymer, e.g., PTFE, article is disclosed. The article is formed from a PTFE resin, calendered, and then expanded (e.g., multiaxially) at an elevated temperature. After cooling, the article is used to form a surgically implanted device, e.g., a surgical prosthetic sling.

What is claimed is: 
     
         1 . An article usable as a supportive surgical implant, the article comprising:
 an elongated body and a first end and a second end, the elongated body formed of a biocompatible, bacteria-resistant fluoropolymer material;   the biocompatible, bacteria-resistant fluoropolymer material being configured of a plurality of nodes and a plurality of fibrils, the plurality of fibrils radiating from and interconnecting the nodes multiaxially.   
     
     
         2 . The article of  claim 1  wherein the biocompatible, bacteria-resistant fluoropolymer material comprises Polytetrafluoroethylene (PTFE). 
     
     
         3 . The article of  claim 2  wherein the biocompatible, bacteria-resistant fluoropolymer material comprises expanded PTFE (ePTFE). 
     
     
         4 . The article of  claim 1  wherein the elongated body is substantially planar. 
     
     
         5 . The article of  claim 1  wherein the article is substantially microporous. 
     
     
         6 . The article of  claim 1  wherein the plurality of fibrils are about 0.5-3 microns in length. 
     
     
         7 . The article of  claim 6 , comprising:
 a plurality of pores defined between the plurality of nodes and fibrils, the plurality of pores having sizes less than or equal to 2 by 1 microns.   
     
     
         8 . The article of  claim 1  wherein the elongated body has a thickness of about 0.60 mm. 
     
     
         9 . The article of  claim 1  wherein the article is configured for use as a tissue support. 
     
     
         10 . The article of  claim 9  wherein the article is configured for use as a pubovaginal sling. 
     
     
         11 . The article of  claim 9  wherein the first end is configured to receive a first surgical placement aid, and the second end is configured to receive a second surgical placement aid. 
     
     
         12 . The article of  claim 1  wherein the biocompatible, bacteria-resistant fluoropolymer material comprises a microporous structure which is relatively closed to ingrowth and bacterial penetration. 
     
     
         13 . A method for producing a supportive surgical implant device, the method comprising:
 mixing a PTFE resin paste with an extrusion aid;   configuring a resin paste and the extrusion aid into a pre-extrusion form;   calendaring the pre-extrusion form to make a PTFE article;   drying the extrusion aid from the PTFE article;   reheating the PTFE article at a temperature higher than a drying temperature used in the drying step, but lower than a melt temperature of the PTFE article;   multiaxially expanding the PTFE article in at least two different directions to create a node/fibril structure;   restraining the PTFE article in an expanded state and heating the PTFE article to a temperature above a thermal transition temperature for the PTFE to lock the node/fibril structure in place;   allowing the article to cool; and   configuring the article for use as the supportive surgical implant.   
     
     
         14 . The method of  claim 13 , wherein the multiaxially expanding step occurs in X and Y directions at about 90 degrees relative to one another. 
     
     
         15 . The method of  claim 13 , wherein the multiaxially expanding step occurs in greater than two directions. 
     
     
         16 . The method of  claim 13 , comprising:
 forming the PTFE article into a sheet; and   causing at least a portion of the sheet to have an elongated body and two ends.   
     
     
         17 . The method of  claim 16 , comprising:
 configuring the ends of the at least a portion of the sheet to attach to surgical placement aids.   
     
     
         18 . The method of  claim 17 , comprising:
 surgically implanting the at least a portion of the sheet into a human body.   
     
     
         19 . A pubovaginal support device configured for surgical implant, the pubovaginal support device comprising:
 an elongated body formed of expanded polytetrafluoroethylene;   a first end and a second end of the body;   the fluoropolymer material being configured of a plurality of nodes and a plurality of fibrils, the plurality of fibrils radiating from and interconnecting the nodes multiaxially.   
     
     
         20 . The pubovaginal support device of  claim 19  wherein the plurality of fibrils are about 0.5-3 microns in length and a plurality of pores defined between the plurality of nodes and fibrils, the plurality of pores have sizes less than or equal to 2 by 1 microns.