Prosthetic surgical sling systems and methods

Abstract

Disclosed are versions of a prosthetic sling manufactured using an expanded fluoropolymer, e.g., PTFE. In some versions, a tubular ePTFE extrusion is, after initially processing, subjected to moderate temperatures and pressures to flatten the tubular extrusion such that it has rounded edges. In other versions a multiaxially expanded ePTFE strip is used.

What is claimed is: 
     
         1 . A method for producing a surgical implant device, the method comprising:
 mixing a polytetrafluoroethylene (PTFE) resin paste with an extrusion aid;   forming the resin paste and the extrusion aid into a billet;   extruding the billet into a PTFE tube;   drying the PTFE tube to remove the extrusion aid;   reheating the PTFE tube at a temperature lower than a melt temperature of the PTFE tube;   expanding the PTFE tube in at least one dimension to create a node/fibril structure;   heating the PTFE tube to a temperature above a thermal transition temperature for the PTFE thus setting a node/fibril structure in place resulting in an expanded tube; and   applying heat and pressure to collapse the expanded tube and adhere the inside tube surfaces together to form a substantially flat article having rounded lateral edges.   
     
     
         2 . The method of  claim 1 , wherein the expanding the PTFE tube in at least one dimension step comprises:
 unidirectionally and longitudinally expanding the PTFE tube resulting a plurality of substantially parallel fibrils interconnecting a plurality of nodes defining a plurality of apertures therebetween, each aperture in the plurality of apertures having a pore size less than 2 microns.   
     
     
         3 . The method of  claim 1  comprising:
 establishing a tube wall thickness in the extruding step of about 0.20 millimeters. 
 
     
     
         4 . The method of  claim 1  comprising:
 allowing the article to cool after the restraining step and the applying heat and pressure step. 
 
     
     
         5 . The method of  claim 1  comprising:
 presenting the article for use as a supportive surgical implant. 
 
     
     
         6 . The method of  claim 1  comprising:
 configuring the article for use as a supportive surgical implant. 
 
     
     
         7 . The method of  claim 6  comprising:
 sizing the article to operate as a supportive surgical implant, and 
 configuring a first end and a second end of the article to attach to surgical placement aids. 
 
     
     
         8 . The method of  claim 6  comprising:
 configuring the article to have a length making the article usable as a supportive surgical implant device having first and second ends. 
 
     
     
         9 . The method of  claim 8  comprising:
 densifying the first and second ends by the application of elevated heat and pressure making the ends apt for the receipt of implantation aids. 
 
     
     
         10 . The method of  claim 9  comprising:
 forming apertures into the first and second ends, the apertures being configured to receive implantation aids. 
 
     
     
         11 . The method of  claim 1  comprising:
 after setting the node/fibril structure in place, and before the step of applying heat and pressure: 
 inserting a meltable filler material into the expanded tube, and 
 melting the filler material to aid in adhering the inside tube surfaces together. 
 
     
     
         12 . The method of  claim 11  comprising:
 selecting Fluorinated Ethylene Propylene (FEP) as the meltable filler. 
 
     
     
         13 . The method of  claim 1  wherein the applying heat and pressure step is executed at a temperature lower than the thermal transition point of the PTFE. 
     
     
         14 . The method of  claim 1  wherein the applying heat and pressure step is executed by:
 sandwiching the expanded tube between a hot surface and another surface under moderate pressure; and 
 applying heat and pressure until porosity is reduced and a now collapsed tube softens. 
 
     
     
         15 . An article usable as a supportive surgical implant, the article comprising:
 a collapsed tube forming an elongated body having a first end and a second end, rounded lateral edges, the elongated body being formed of a biocompatible, bacteria-resistant fluoropolymer material, the fluoropolymer material being configured to have a plurality fibrils connecting between nodes.   
     
     
         16 . The article of  claim 15  wherein the biocompatible, bacteria-resistant fluoropolymer material comprises Polytetrafluoroethylene (PTFE). 
     
     
         17 . The article of  claim 16  wherein the bacteria-resistant fluoropolymer comprises expanded PTFE (ePTFE). 
     
     
         18 . The article of  claim 17  wherein the plurality of fibrils extend longitudinally substantially in parallel, and the plurality of fibrils and plurality of nodes together define a plurality of pores having sizes of 2 microns or less in smallest dimension. 
     
     
         19 . The article of  claim 15  wherein the article is configured for use as a tissue support. 
     
     
         20 . The article of  claim 19  wherein the article is configured for use as a pubovaginal sling. 
     
     
         21 . The article of  claim 19  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. 
     
     
         22 . The article of  claim 15  wherein the bacteria-resistant fluoropolymer comprises a microporous structure which is relatively closed to ingrowth and bacterial penetration.