Radially expandable tubular polytetrafluoroethylene grafts and method of making same

• US 6,039,755 A
• Filed: 02/05/1997
• Issued: 03/21/2000
• Est. Priority Date: 02/05/1997
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Hurry, Fariba, Banas, Christopher E., Edwin, Tarun J.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/794,871
• Time in Patent Office: 1,140 Days
• Field of Search: 623/1, 623/11, 623/12, 606/151-158, 606/193, 606/194, 600/36
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 55/005 characterised by the choice of materials
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2262/0253 Polyolefin fibres
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses or catheter
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

Tubular ePTFE materials which are capable of being radially expanded under the influence of a radially outward force applied from the lumen of the ePTFE tubular material to substantially uniformly radially deform the ePTFE material. The ePTFE material is radially expandable to a diameter 700% its unexpanded diameter under the influence of pressures less than 6 atm while retaining the structural integrity of the ePTFE microstructure. Conservation of the structural integrity of the ePTFE material is determined by conservation of the ePTFE microstructure structural integrity.

Claims

1. A continuous tubular structure comprising an expanded polytetrafluoroethylene material having a predetermined wall thickness and a microstructure characterized by a plurality of nodes interconnected by fibrils, the fibrils having an orientation substantially parallel to a longitudinal axis of the polytetrafluoroethylene tubular material throughout the wall thickness of the tubular structure and the nodes having a longitudinal axis substantially perpendicular to the longitudinal axis of the polytetrafluoroethylene material, the polytetrafluoroethylene material of the tubular structure being capable of undergoing radial deformation from an original unexpanded diameter of the tubular structure to a larger diameter of the tubular structure by application of a positive pressure applied through the lumen of the tubular structure and radially outward therefrom which causes a plurality of the nodes in the microstructure to undergo elongation along the longitudinal axis of the nodes, while substantially retaining an average internodal distance throughout the wall thickness of the radially deformed tubular structure.

2. The continuous tubular structure according to claim 1, wherein the expanded polytetrafluoroethylene tubular material is radially deformable between about 50% to 700% its original diameter without loss of structural integrity.

3. The continuous tubular structure according to claim 2, wherein the polytetrafluoroethylene material has longitudinal and radial tensile strengths and an average node length, and is radially deformable to at least 50% its original diameter at applied positive pressures less than about 6 atm.

4. The continuous tubular structure according to claim 3, wherein the tubular structure at the original unexpanded diameter and the larger diameter each have a water entry pressure value and wherein the expanded polytetrafluoroethylene is radially deformable to between 50% to 700% its original diameter with the water entry pressure value of the radially deformed material remaining within ±

60% of the water entry pressure value of the tubular material in its original unexpanded diameter.

5. The continuous tubular structure according to claim 3, wherein the expanded polytetrafluoroethylene is radially deformable to between 50% to 700% its original diameter wherein wall thickness of the graft maintains its concentricity and is free of gross tears or fractures.

6. The continuous tubular structure according to claim 3, wherein the expanded polytetrafluoroethylene material is radially deformable to between 50% to 700% its original diameter wherein the longitudinal tensile strength remains within ±

100% of the longitudinal tensile strength of the material in its original unexpanded diameter.

7. The continuous tubular structure according to claim 3, wherein the expanded polytetrafluoroethylene material is radially deformable to between 50% to 700% its original diameter wherein the radial tensile strength remains within ±

40% of the radial tensile strength of the material in its original unexpanded diameter.

8. The continuous tubular structure according to claim 3, wherein the expanded polytetrafluoroethylene material is radially deformable to between 50% to 700% its original diameter wherein average nodal elongation in the radially deformed tubular structure is no more than about 300% the average node length of the tubular structure in its original unexpanded diameter.

9. The continuous tubular structure according to claim 3, further including a radially expandable stent member concentrically positioned within the lumen of the tubular structure.

10. The continuous tubular structure according to claim 9, wherein the radially expandable stent member is selected from the group of stents consisting of balloon expandable, self expanding and memory shape stent members.

11. The continuous tubular structure according to claim 10, further including a second continuous tubular structure comprised of polytetrafluoroethylene concentricity positioned with the lumen of the stent member and in intimate contact with the stent member and the continuous tubular structure.

12. The continuous tubular structure according to claim 1, further including a radially expandable stent member concentrically positioned about at least one of an outer, abluminal surface and a luminal surface of the continuous tubular structure.

13. The continuous tubular structure according to claim 12, wherein the radially expandable stent member is selected from the group of stents consisting of balloon expandable, self expanding, and shape memory stent members.

14. A tubular expanded polytetrafluoroethylene member having a determined wall thickness, comprising a material microstructure characterized by a plurality of nodes interconnected by fibrils, the fibrils having an orientation substantially parallel to a longitudinal axis of the tubular expanded polytetrafluoroethylene member and throughout the redetermined wall thickness thereof and the nodes having a longitudinal axis substantially perpendicular to the longitudinal axis of the tubular expanded polytetrafluoroethylene member, the tubular expanded polytetrafluoroethylene member being capable of undergoing radial deformation under an influence of a positive pressure of less than or equal to about 6 atm applied through the lumen of the polytetrafluoroethylene tubular material and directed radially outward therefrom which acts to cause at least some of the nodes to elongate along their longitudinal axis while substantially retaining an average internodal distance throughout the microstructure of the radially deformed tubular expanded polytetrafluoroethylene member which is substantially the same as that of the non-radially deformed tubular expanded polytetrafluoroethylene member.