Skewed nodal-fibril ePTFE structure

• US 7,785,363 B2
• Filed: 08/15/2007
• Issued: 08/31/2010
• Est. Priority Date: 08/15/2007
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Sowinski, Krzysztof, Duran, Julio, Henderson, Jamie S.
• Primary Examiner(s): Isabella; David
• Assistant Examiner(s): Woznicki; Jacqueline
• Application Number:
  US11/893,346
• Publication Number:
  US 20090048658A1
• Time in Patent Office: 1,112 Days
• Field of Search: 623 11- 154, 623/1.15
• US Class Current: 623/1.15
• 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: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: B29C 53/14 Twisting for textile fibres D01H
• CPC Class Codes: B29C 55/24 radial
• CPC Class Codes: B29C 55/26 biaxial
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B29L 2023/007 Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2031/7534 Cardiovascular protheses
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2597/00 Tubular articles, e.g. hoses, pipes
• CPC Class Codes: B32B 27/12 next to a fibrous or filamentary layer
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device
• CPC Class Codes: Y10T 428/13 Hollow or container type article [e.g., tube, vase, etc.]
• CPC Class Codes: Y10T 428/1352 Polymer or resin containing [i.e., natural or synthetic]
• CPC Class Codes: Y10T 428/1362 Textile, fabric, cloth, or pile containing [e.g., web, net, woven, knitted, mesh, nonwoven, matted, etc.]
• CPC Class Codes: Y10T 428/1376 Foam or porous material containing
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 : Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/1397 : Single layer [continuous layer]
• CPC Class Codes: Y10T 428/249964 : Fibers of defined composition

Abstract

The ePTFE structure includes an ePTFE tubular structure having opposite ends and a longitudinal axis. The ePTFE tubular structure is formed from rotating the opposite ends relative to one another in a direction of rotation about the longitudinal axis. The ePTFE tubular structure has a node and fibril micro-structure in which substantially all of the fibrils are oriented in the direction of rotation.

Claims

1. An ePTFE structure comprising an ePTFE tubular structure having opposite ends and a longitudinal axis, said ePTFE tubular structure being formed by rotating said opposite ends relative to one another in a direction of rotation about said longitudinal axis, said ePTFE tubular structure comprising a node and fibril micro-structure, wherein the node and fibril micro-structure comprises nodes and fibrils,

wherein each node comprises a longitudinal axis therethrough, in which substantially all of said fibrils are longitudinally oriented in said direction of rotation, wherein the direction of rotation is oblique to the longitudinal axis of said tubular structure, wherein the longitudinal axis of each nodes is perpendicular to the longitudinal axis of the tubular structure, and the fibrils are rotated relative to the nodes and the longitudinal axis.

2. An ePTFE structure according to claim 1, wherein about 75% of said fibrils of said node and fibril micro-structure are oriented in said direction of rotation.

3. An ePTFE structure according to claim 2, wherein about 85% of said fibrils of said node and fibril micro-structure are oriented in said direction of rotation.

4. An ePTFE structure according to claim 3, wherein about 95% of said fibrils of said node and fibril micro-structure are oriented in said direction of rotation.

5. An ePTFE structure according to claim 1, wherein said nodes of said node and fibril micro-structure have a transverse orientation relative to said longitudinal axis.

6. An ePTFE structure according to claim 1, wherein said ePTFE tubular structure constitutes a cover ePTFE tubular structure, said direction of rotation defining a first direction of rotation,

said ePTFE structure comprising a liner ePTFE tubular structure having opposite ends and a longitudinal axis, said liner ePTFE tubular structure being formed from rotating said opposite ends thereof relative to one another in a second direction of rotation about said longitudinal axis of said liner ePTFE tubular structure, said liner ePTFE tubular structure having a node and fibril micro-structure in which substantially all of said fibrils are oriented in said second direction of rotation,

said liner ePTFE tubular structure being secured to said cover ePTFE tubular structure such that said cover and liner ePTFE tubular structures are in coaxial relation to one another.

7. An ePTFE structure according to claim 6, wherein said first direction of rotation is opposite to said second direction of rotation.

8. An ePTFE structure according to claim 6, and further comprising a stent structure located between said cover and liner ePTFE tubular structures such that said stent structure is secured to said cover and liner ePTFE tubular structures.

9. An ePTFE structure comprising an ePTFE tubular structure having opposite ends located along a longitudinal axis, said ePTFE tubular structure comprising a node and fibril micro-structure, wherein the node and fibril micro-structure comprises nodes and fibrils, wherein the nodes each comprise a longitudinal axis therethrough, in which substantially all of said fibrils have an inclined orientation relative to said longitudinal axis of the tubular structure wherein said inclined orientation is substantially constant between said opposite ends, wherein the longitudinal axis of each nodes is perpendicular to the longitudinal axis of the tubular structure, and wherein substantially all the fibrils are at an oblique angle relative to the longitudinal axis and the nodes.

10. a method for making an ePTFE structure, said method comprising:

providing an ePTFE tubular structure having a longitudinal axis and opposite ends, the ePTFE tubular structure having a node and fibril micro-structure, wherein the node and fibril micro-structure comprises nodes and fibrils, fixing one end of the ePTFE tubular structure to obstruct rotation thereof about the longitudinal axis of the ePTFE tubular structure, rotating the other end of the ePTFE tubular structure about the longitudinal axis thereof to orient the fibrils of the node and fibril micro-structure in the direction of rotation of the other end relative to the one end of the ePTFE tubular structure;

wherein the nodes of the node and fibril micro-structure each have a longitudinal axis therethrough, and wherein the longitudinal axis of each of the nodes are perpendicular to the longitudinal axis and the fibrils are at an oblique angle relative to the longitudinal axis and the nodes.

11. A method according to claim 10, wherein said rotating comprises rotating the other end of the ePTFE tubular structure up to about 720 degrees around the longitudinal axis relative to the one end of the ePTFE tubular structure.

12. A method according to claim 10, and further comprising relaxing the fibrils before said rotating and after extruding and providing.

13. A method according to claim 12, wherein said relaxing comprises limiting the support of the ePTFE tubular structure to allow expansion and contraction thereof,

said relaxing further comprising heating the ePTFE tubular structure such that a temperature thereof is maintained at about 300 to 600 degrees F. for a duration of about 1 to 30 minutes.

14. A method according to claim 10, wherein said extruding and providing comprises providing a PTFE green tube, said method further comprising longitudinally expanding the PTFE green tube to form the ePTFE tubular structure before said fixing thereof such that said fixing and rotating is of the ePTFE tubular structure which has been longitudinally expanded.

15. A method according to claim 10, and further comprising radially expanding the ePTFE tubular structure after said rotating.

16. A method according to claim 10, wherein the ePTFE tubular structure constitutes a cover ePTFE tubular structure,

said method further comprising providing a liner ePTFE tubular structure which has a longitudinal axis, the liner ePTFE tubular structure having a node and fibril micro-structure,

said method further comprising fixing one end of the liner ePTFE tubular structure to obstruct rotation thereof about the longitudinal axis of the liner ePTFE tubular structure,

said method further comprising rotating a second end of the liner ePTFE tubular structure about the longitudinal axis of the liner ePTFE tubular structure to orient the fibrils in the direction of rotation of the second end of the liner ePTFE tubular structure relative to the one end of the liner ePTFE tubular structure,

said method further comprising securing the cover and liner ePTFE tubular structures to one another such that the liner ePTFE tubular structure is within the cover ePTFE tubular structure in coaxial relation therewith.

17. A method according to claim 16, wherein said rotating of said cover ePTFE tubular structure provides the fibrils thereof with an orientation in the direction of rotation of the second end of the cover ePTFE tubular structure which constitutes a first direction of rotation,

said rotating of said liner ePTFE tubular structure provides the fibrils thereof with an orientation in the direction of rotation of the second end of the liner ePTFE tubular structure which constitutes a second direction of rotation such that said second direction of rotation is different from said first direction of rotation.

18. A method according to claim 17, wherein said rotating of said cover ePTFE tubular structure and said rotating of said liner ePTFE tubular structure provides for said first and second directions of rotation to oppose one another after said securing.

19. A method according to claim 17, wherein the ePTFE tubular structure constitutes a cover ePTFE tubular structure,

said method further comprising restraining the fibrils of the node and fibril micro-structure from returning to an orientation thereof relative to the longitudinal axis before a completion of said rotating,

said method further comprising providing a liner ePTFE tubular structure,

said method further comprising securing the cover and liner ePTFE tubular structures to one another such that the liner ePTFE tubular structure resists the fibrils from returning to an orientation thereof relative to the longitudinal axis of the cover ePTFE tubular structure before said completion of said rotating.

20. A method according to claim 16, and further comprising providing a stent structure before said securing, said securing further comprising securing the stent structure to the cover and liner ePTFE tubular structures such that the stent structure is between the cover and liner ePTFE tubular structures.