Prosthetic surgical sling
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., uniaxially, multiaxially, etc.) at an elevated temperature. After cooling, the article is used to form a surgically implanted device, e.g., a surgical prosthetic sling.
1 . A surgical implant comprising:
an elongated flat implant body having first and second ends, the implant body being configured to support a body tissue, the body formed of a biocompatible, bacteria-resistant fluoropolymer material,
wherein the biocompatible, bacteria-resistant fluoropolymer material comprises a plurality of nodes and a plurality of fibrils, wherein the implant body is multiaxially expanded such that the plurality of fibrils radiate between the plurality of nodes to define a plurality of pores, each of the plurality of pores each having a length and a width, a smallest of the length or width being about equal to or less than about 2 micron, wherein more than about 80% of the implant body is comprised of solid nodes, and
wherein the biocompatible, bacteria-resistant fluoropolymer material comprises a microporous structure which is closed to ingrowth and bacterial penetration.
2 . The surgical implant of claim 1 , wherein the biocompatible, bacteria-resistant fluoropolymer material comprises Polytetrafluoroethylene (PTFE).
3 . The surgical implant of claim 2 , wherein the biocompatible, bacteria-resistant fluoropolymer material comprises expanded PTFE (ePTFE).
4 . The surgical implant of claim 1 , wherein the surgical implant is substantially microporous.
5 . The surgical implant of claim 1 , wherein the plurality of fibrils are about 0.5 to about 3 microns in length.
6 . The surgical implant of claim 1 , wherein the plurality of pores defined between the plurality of nodes and fibrils are less than or equal to 2 by 1 microns in size.
7 . The surgical implant of claim 1 , wherein the implant body has a thickness of about 0.60 mm.
8 . The surgical implant of claim 1 , wherein the surgical implant is configured for use as a pubovaginal sling.
9 . The surgical implant of claim 8 , 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.
10 . The surgical implant of claim 1 , wherein the plurality of pores are about 0.5 microns to about 1.0 microns.
11 . The surgical implant of claim 1 , wherein the implant body is configured for organ engagement.
12 . The surgical implant of claim 1 , wherein the implant body is configured for the receipt of surgical placement aids.
13 . An expanded PTFE tissue-engaging surgical implant comprising
a body formed of expanded PTFE, the body having:
a microporous structure including a plurality of nodes and a plurality of multiaxially-radiating fibrils, the plurality of multiaxially-radiating fibrils radiate between the plurality of nodes to establish a plurality of pores, each of the plurality of pores having sizes which are less than or equal to about 2 microns, wherein more than about 80% of the body is comprised of solid nodes, and
the microporous structure being closed to ingrowth and bacterial penetration.
14 . The expanded PTFE tissue-engaging surgical implant of claim 13 , wherein the plurality of multiaxially-radiating fibrils have lengths from about 0.5 microns to about 1.0 microns.
15 . The expanded PTFE tissue-engaging surgical implant of claim 13 , having smooth edges which prevent damage upon implant.