Vascular endoprosthesis and method

• US 6,423,089 B1
• Filed: 04/22/1999
• Issued: 07/23/2002
• Est. Priority Date: 12/03/1996
• Status: Expired due to Term

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Gingras, Peter, Karwoski, Theodore, Martakos, Paul, Herweck, Steve A.
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): RODRIGUEZ, CRIS LOIREN
• Application Number:
  US09/296,349
• Time in Patent Office: 1,188 Days
• Field of Search: 604/96, 604/104, 604/264, 604/523, 604/96.01, 606/108, 606/191, 606/198, 623/1.1, 623/1.11, 623/1.12, 623/1.39, 623/1, 623/11, 623/12
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A vascular endoprosthesis is formed of a tubular liner preform with a continuous surface and having a diameter smaller than that of an intended vessel. The liner is inserted to a treatment site, and its sheet material undergoes a radially-directed expansion to a final size that fits the vessel. Insertion and in situ expansion are achieved using a catheter assembly in which either an internal stent, such as a stiff-filament helically woven tube, or an inflatable balloon urge the liner preform outwardly against the inner wall of the vessel. The stent, or one or more simple internal snap-rings anchor the expanded liner in place. The expanded liner is porous, or becomes more porous during expansion, and one or more aspects of its porosity are tailored to the intended treatment goal of immobilizing treatment material, isolating cells, or permitting controlled permeation of selected materials.

Claims

1. A device for treating stenosis, the device comprising:

a catheter having a catheter body sized for insertion into a body vessel,

a tubular liner of porous expanded fluoropolymer having a microstructure of nodes and fibrils having a negligible Poisson coupling, the liner having an original diameter sized for positioning through the catheter body to a desired location within the body vessel, and

a radial expansion element positionable within the liner through the catheter body for enlarging the diameter of the liner without significantly changing the length of the liner.

2. The device of claim 1, wherein the radial expansion element is a balloon.

3. The device of claim 2, wherein the catheter body includes an inflation tube to permit inflation of the balloon.

4. The device of claim 1, wherein the radial expansion element is a stent.

5. The device of claim 4, wherein the catheter body includes actuation means for expanding the stent.

6. The device of claim 1, wherein the fluoropolymer is PTFE.

7. A device for treating stenosis, the device comprising:

a catheter having a catheter body sized for insertion into a body vessel,

a tubular liner of porous expanded fluoropolymer having a microstructure of nodes and fibrils having a negligible Poisson coupling, and an original diameter less than the body vessel diameter and sized for positioning through the catheter body to a desired location within the body vessel, and

a radial expansion element positionable within the liner through the catheter body, the radial expansion element deforming liner by expanding the liner to a diameter greater than the original diameter.

8. The device of claim 7, wherein the radial expansion element is a balloon.

9. The device of claim 8, wherein the catheter body includes an inflation tube to permit inflation of the balloon.

10. The device of claim 7, wherein the radial expansion element is a stent.

11. The device of claim 10, wherein the catheter body includes actuation means for expanding the stent.

12. The device of claim 7, wherein the fluoropolymer is PTFE.

13. The device of claim 7, wherein the nodes forming the microstructure of the tube have a mass sufficient to provide the tube with negligible Poisson coupling.

14. The method of claim 7, wherein a substantial plurality of the nodes are circumferentially-oriented and extend for a distance greater than 100 micrometers in circumferential direction around the tube.

15. A method of treating stenosis, the method comprising the steps of:

inserting a tubular liner of porous expanded fluoropolymer to a desired location within a body vessel, the liner having a microstructure of nodes and fibrils, the nodes having a mass sufficient to provide the tube with negligible Poisson coupling, and

radially expanding the liner without significantly changing the length of the liner.

16. The method of claim 15, wherein the step of radially expanding the liner includes the steps of positioning a stent within the liner and radially-expanding the stent to expand the liner.

17. The method of claim 15, wherein the step of radially expanding includes the steps of positioning a radially-expandable balloon within the liner and inflating the balloon to expand the liner.

18. The method of claim 15, wherein the microstructure of the liner has a porosity after expansion of a size to permit ingrowth of cells.

19. The method of claim 15, wherein the microstructure of the liner has a porosity after expansion of a size too small to permit cell ingrowth, but large enough to allow permeation of gas and fluid.

20. The method of claim 15, wherein the microstructure of the liner has a porosity after expansion which preferentially enables permeation radially between its inside and its outside.

21. The method of claim 15, wherein the fluoropolymer is polytetrafluoroethelyne (PTFE).

22. A method of treating vascular stenosis, the method comprising the steps of:

inserting a tubular liner of porous expanded fluoropolymer to a desired location with a body vessel, the liner having a microstructure of nodes and fibrils having a negligible Poisson coupling, and an original diameter less than the vessel diameter, and

plastically deforming the liner by radially expanding the liner to a final diameter greater than the original diameter.

23. The method of claim 22, wherein the step of deforming the liner includes the steps of positioning a stent within the liner and radially-expanding the stent to deform the liner.

24. The method of claim 22, wherein the step of deforming the liner includes the steps of positioning a radially-expandable balloon within the liner and inflating the balloon to deform the liner.

25. The method of claim 22, wherein the step of deforming the liner radially expands the liner without significantly changing the length of the liner.

26. The method of claim 22, wherein the fluoropolymer is PTFE.