Luminal graft endoprostheses and manufacture thereof

• US 5,653,747 A
• Filed: 10/20/1995
• Issued: 08/05/1997
• Est. Priority Date: 12/21/1992
• Status: Expired due to Term

• Current Assignee: Corvita Corporation (Boston Scientific Corporation)
• Original Assignee: Corvita Corporation (Boston Scientific Corporation)
• Inventors: Dereume, Jean-Pierre Georges Emile
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/546,524
• Time in Patent Office: 655 Days
• Field of Search: 623/1, 623/11, 623/12
• US Class Current: 623/1.54
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 69/00 Compositions of polycarbonates; Compositions of derivatives of polycarbonates

Abstract

A luminal endovascular graft or endoprosthesis having a tubular support which expands between a first diameter and a second, larger diameter is provided with an expandable porous coating which is applied over either or both of the internal cylindrical surface and the external cylindrical surface of the tubular support. The first diameter allows the introduction of the luminal endoprosthesis into human or animal body passages. The expandable coating preferably is made from biocompatible fibers formed into a structure which allows normal cellular invasion upon implantation, without stenosis or restenosis, when the support element is at its second diameter.

Claims

1. A luminal endoprosthesis for deployment within a living body pathway, comprising:

a tubular expandable support element with a longitudinal axis, an external generally cylindrical surface and an internal generally cylindrical surface, said support element being expandable from a first diameter at which it is adapted to be inserted into a living human or animal body pathway a second diameter, the second diameter being greater than the first diameter, said expandable support element being capable of supporting walls of the living body pathway when at the second diameter, said second diameter being 1.5 to 12 times greater than said first diameter of the expandable support element;

an expandable porous coating made from an essentially inert biocompatible material, said expandable coating being applied over at least one of said external and internal generally cylindrical surfaces of the expandable support element;

said tubular expandable support element extending substantially the full length of the expandable porous coating;

the expandable coating is made from porous material having pores that open when the tubular support element expands from said first diameter to said second diameter to provide open pores which allow normal cellular invasion thereinto from the body pathway when implanted therewithin;

said expandable porous coating is an elastomeric fibrous material of elastomeric fibers, said fibers being essentially inert and each is linear and oriented at an angle β

with respect to the longitudinal axis of the tubular support element when at its first diameter, said angle β

being less than about 80°

;

said elastomeric fibers being arranged in a plurality of at least 10 layers of superimposed fibers, each fiber of which extends substantially the length of said tubular support element, with the fibers in each of the superimposed layers being oriented in such a manner that they cross the fibers of at least an upper neighboring layer or at least a lower neighboring layer in order to provide crossed fibers; and

said crossed fibers reorient with respect to one another when the tubular support element expands such that said angle β

of each fiber increases and thereby defines said pores that open when the tubular support element expands from said first diameter to said second diameter and that are thus oriented to allow said normal cellular invasion.

2. The luminal endoprosthesis in accordance with claim 1, further including openings between the fibers of fibrous material when the support is at its second diameter, said openings being greater than about 1μ

.

3. The luminal endoprosthesis in accordance with claim 2, wherein said openings are at least about 10μ

.

4. The luminal endoprosthesis in accordance with claim 2, wherein said openings are between about 30μ

and about 100μ

.

5. The luminal endoprosthesis in accordance with claim 1, wherein said angle β

is less than about 30°

.

6. The luminal endoprosthesis in accordance with claim 1, wherein said fibers of the fibrous material are polycarbonate urethane.

7. The luminal endoprosthesis in accordance with claim 1, wherein the fibers of the fibrous material have a diameter of about 1μ

to about 30μ

.

8. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating has between about 50 and about 300 layers of superimposed fibrous material.

9. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating is applied onto the external generally cylindrical surface of the support element.

10. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating is applied onto the internal generally cylindrical surface of the support element.

11. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating is applied onto both the external generally cylindrical surface and the internal generally cylindrical surface of the support element.

12. The luminal endoprosthesis in accordance with claim 1, wherein the support element has two axially extending ends, at least one of which is without said expandable coating and extends axially beyond the expandable coating.

13. The luminal endoprosthesis in accordance with claim 12, wherein said at least one axially extending end of the support element projects radially outward when the support element is in its second diameter, whereby said axially extending end serves as a member for the fixation of the endoprosthesis into the body pathway.

14. The luminal endoprosthesis in accordance with claim 1, wherein the support element is expanded by applying an outwardly directed radial force thereto.

15. The luminal endoprosthesis in accordance with claim 1, wherein the support element is auto-expandable.

16. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating is adhered to the support element.

17. The luminal endoprosthesis in accordance with claim 1, wherein the expandable coating is adhered to the support element by an adhering agent selected from the group consisting of an adhesive, a hot melt adhesive, a silicone adhesive, a primer, a coupling agent, and combinations thereof.

18. The luminal endoprosthesis in accordance with claim 1, wherein the support element is encapsulated between one said expandable coating over the external generally cylindrical surface of the support element and another said expandable coating over the internal generally cylindrical surface of the support element.