Highly porous self-cohered web materials having haemostatic properties

• US 7,659,219 B2
• Filed: 01/30/2006
• Issued: 02/09/2010
• Est. Priority Date: 07/29/2005
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Enterprise Holdings Incorporated (W.L. Gore and Associates)
• Inventors: Biran, Roy, Cully, Edward H., White, Charles F., Flynn, Charles, Off, Philip P., Farnsworth, Ted R.
• Primary Examiner(s): Chriss; Jennifer A
• Application Number:
  US11/343,509
• Publication Number:
  US 20070027554A1
• Time in Patent Office: 1,471 Days
• Field of Search: None
• US Class Current: 442/401
• CPC Class Codes: A61B 17/07292 Reinforcements for staple line, e.g. pledgets
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: Y10T 442/608 Including strand or fiber material which is of specific structural definition
• CPC Class Codes: Y10T 442/674 Nonwoven fabric with a preformed polymeric film or sheet
• CPC Class Codes: Y10T 442/677 Fluorinated olefin polymer or copolymer sheet or film [e.g., TeflonR, etc.]
• CPC Class Codes: Y10T 442/681 Spun-bonded nonwoven fabric
• CPC Class Codes: Y10T 442/682 Needled nonwoven fabric
• CPC Class Codes: Y10T 442/688 Containing polymeric strand or fiber material

Abstract

The present invention is directed to implantable bioabsorbable non-woven self-cohered web materials having a high degree of porosity. The web materials are very supple and soft, while exhibiting proportionally increased mechanical strength in one or more directions. The web materials often possess a high degree of loft. The web materials can be formed into a variety of shapes and forms suitable for use as implantable medical devices or components thereof. The web materials possess haemostatic properties.

Claims

1. An implantable article comprising melt-formed abraded bioabsorbable filaments and melt-formed continuous bioabsorbable filaments to form a porous web material, wherein said material is formed by self-cohering filaments to each other at multiple contact points and then subjecting the material to a carding procedure where at least some of the filaments are engaged and separated from each other, wherein said filaments comprise at least one semi-crystalline polymeric component covalently bonded to or blended with at least one amorphous polymeric component, wherein the filaments possess partial to full polymeric component phase immiscibility when in a crystalline state, and wherein said implantable article has a percent porosity greater than ninety absent inclusion of any fillers or other added components that may effectively reduce said porosity;

and

a non-bioabsorbable material releasably attached to a population of said melt-formed filaments.

2. The implantable article of claim 1 wherein the percent porosity is greater than ninety-one absent inclusion of any fillers or other added components that may effectively reduce said porosity.

3. The implantable article of claim 1 wherein the at least one semi-crystalline polymeric component is covalently bonded to at least one amorphous polymeric component.

4. The implantable article of claim 3 wherein the components comprise a block copolymer.

5. The implantable article of claim 1 wherein the at least one semi-crystalline polymeric component is blended with the at least one amorphous polymeric component.

6. The implantable article of claim 5 wherein at least one of the components is a block co-polymer.

7. The implantable article of claim 1 wherein at least one semi-crystalline polymeric component has a melting point greater than eighty degrees centigrade (80°

C.).

8. The implantable article of claim 1 wherein said non-bioabsorbable material comprises a fluoropolymer.

9. The implantable article of claim 8 wherein said fluoropolymer is polytetrafluoroethylene.

10. The implantable article of claim 1 wherein said non-bioabsorbable material has a side that is a barrier to cellular ingrowth.

11. The implantable article of claim 10 wherein said population of filaments is attached to said side of said non-bioabsorbable sheet material that is a barrier to cellular ingrowth.

12. The implantable article of claim 1 in the form of a substantially planar sheet.

13. The implantable article of claim 1 in the form a two or more planar sheets.

14. The implantable article of claim 13 wherein said sheets are attached together to form a laminate.

15. An implantable article comprising melt-formed abraded bioabsorbable filaments and melt-formed continuous bioabsorbable filaments to form a porous web material, wherein said material is formed by self-cohering filaments to each other at multiple contact points and then subjecting the material to a carding procedure where at least some of the filaments are engaged and separated from each other, wherein said filaments comprise at least one semi-crystalline polymeric component covalently bonded to or blended with at least one additional semi-crystalline polymeric component, wherein the filaments possess partial to full polymeric component phase immiscibility when in a crystalline state, and wherein said implantable article has a percent porosity greater than ninety absent inclusion of any fillers or other added components that may effectively reduce said porosity;

and

a non-bioabsorbable material releasably attached to a population of said melt-formed filaments.

16. The implantable article of claim 15 wherein the percent porosity is greater than ninety-one absent inclusion of any fillers or other added components that may effectively reduce said porosity.

17. The implantable article of claim 15 wherein the at least one semi-crystalline polymeric component is covalently bonded to at least one amorphous polymeric component.

18. The implantable article of claim 17 wherein the components comprise a block copolymer.

19. The implantable article of claim 15 wherein the at least one semi-crystalline polymeric component is blended with the at least one amorphous polymeric component.

20. The implantable article of claim 19 wherein at least one of the components is a block co-polymer.

21. The implantable article of claim 15 wherein at least one semi-crystalline polymeric component has a melting point greater than eighty degrees centigrade (80°

C.).

22. The implantable article of claim 15 wherein said non-bioabsorbable material is a fluoropolymer.

23. The implantable article of claim 22 wherein said fluoropolymer comprises polytetrafluoroethylene.