Prosthesis with in-wall modulation

• US 5,824,050 A
• Filed: 12/03/1996
• Issued: 10/20/1998
• 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, Martakos, Paul, Karwoski, Theodore, Herweck, Steve A., Swanick, Tom
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/760,115
• Time in Patent Office: 686 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/151-158, 606/194, 606/195
• US Class Current: 623/1.4
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/105 Skin implants, e.g. artificial skin
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/34 Macromolecular materials
• CPC Class Codes: A61L 27/40 Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

The wall of a prosthesis has a region which modulates communication through the porosity of the wall. The prosthesis is unitary, but may be assembled in successive bodies which are coalesced, so that the porous microstructure changes distinctly at stages through the thickness dimension of the wall. One embodiment is formed entirely of fluoropolymer, and has at least one surface adapted to support tissue regeneration and ingrowth. The modulation region is a stratum of high water entry pressure that reduces pulsatile hydraulic pressure transmission, or locally alters fluid-born-distribution of biological material through the wall and allows more natural gradients for tissue regeneration and growth in the outer region of the wall.

Claims

1. A prosthetic member comprising

a prosthesis wall having at least first, second and third portions along a wall thickness,

said first portion including a porous inner portion extending continuously along an axis

said second portion being contiguous to said first portion and forming a barrier impenetrable to cell growth and being permeable with a water entry pressure higher than said first portion

said third portion lying over said second portion and extending as a continuous body along said axis

said first, second and third portions being coalesced together to form said wall having cellularly penetrable first and third portions and said second portion modulates cellular penetration of said first and third portions.

2. A prosthetic member according to claim 1, wherein said second portion barrier has a porosity less than fifty micrometers effective to block growth of cells and block transport of large molecules while allowing gases and small soluble molecules to pass through said second portion.

3. A prosthetic member according to claim 1, wherein said first and third portions are continuous tubes and said second portion is a biased wrap.

4. A prosthetic member according to claim 1, wherein said first and third portions are continuous tubes and said second portion is a non-biased wrap.

5. A prosthetic member according to claim 1, wherein said first, second and third portions are each continuous tubes.

6. A prosthetic member according to claim 5, wherein said first and third portions are stretched in at least one direction, and said second portion is substantially unstretched.

7. A prosthetic member according to claim 5, wherein said first and third portions are stretched in a common direction, and said second portion is stretched to form fibrils which are oriented in said second portion across said common direction.

8. A prosthetic member according to claim 1, wherein said second portion barrier has a water entry pressure which prevents weeping after said wall has been wetted.

9. A prosthetic member according to claim 1, wherein said third portion is formed of a porous fluoropolymer having a node and fibril microstructure, wherein the fibrils extend along the axis of said tube and the nodes are oriented to form channels between adjacent nodes, the channels being transverse to said wall and tapering smaller as they extend inwardly.

10. A prosthetic member comprising

a prosthesis wall formed entirely of fluoropolymer having at least first, second and third portions along a wall thickness,

said first portion including a porous inner section extending continuously along an axis

said second portion being contiguous to said first portion and forming a stratum which has a permeability effective for modulating hydrostatic pressure

said third portion overlying said second portion and including a porous section extending as a continuous body along said axis

said first, second and third portions being coalesced together to form said wall such that the wall has a cellularly penetrable surface and said second portion modulates fluid communication through the wall while preventing cellular growth in said second portion.

11. A prosthetic member comprising

an implantable body including a prosthetic wall having first, second and third portions

said first portion extending over an area and having a penetrable surface conducive to cellular ingrowth

said second portion having a low permeability that allows passage of gas and fluid at a controlled rate, and

said third portion having a penetrable surface conducive to cellular ingrowth,

said first, second and third portions being arranged along a thickness dimension and coalesced together to form said prosthetic wall as an integral structure of said implantable body to control cellular growth in said first and third portions through modulation by said second portion of transport and fluid communication in the wall.