Medical implant

• US 4,986,831 A
• Filed: 04/25/1988
• Issued: 01/22/1991
• Est. Priority Date: 04/25/1988
• Status: Expired due to Fees

• Current Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Original Assignee: Angeion Corporation (Niterra Co., Ltd.)
• Inventors: Kane, Lawrence M., Adams, Theodore P., King, Wendell L.
• Primary Examiner(s): Cannon, Alan W.
• Application Number:
  US07/186,002
• Time in Patent Office: 1,002 Days
• Field of Search: 623/1, 623/12, 623/13, 128/334 R
• US Class Current: 600/36
• CPC Class Codes: A61B 90/00 Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges protective face masks A41D13/11; surgeon's or patient's gowns or dresses A41D13/12; devices for carrying-off, for treatment of, or for carrying-over, body liquids A61M1/00
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite
• CPC Class Codes: A61L 27/08 Carbon ; Graphite
• CPC Class Codes: A61L 27/14 Macromolecular materials
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/04 Macromolecular materials
• CPC Class Codes: C08L 23/12 Polypropene
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

This invention is described and illustrated in connection with the generation of a homograft composed of collagenous tissue generated on a prosthetic device. A tubular substrate having generally cylindrical outside and inside surfaces is suspended in the lumen of a blood vessel of a living body. The tubular substrate is open at each end to permit blood to flow over both the inside and outside surfaces. One of the surfaces of the substrate is a thrombogenic surface or supports a thrombogenic mesh material to promote growth of a tube of collagenous tissue suitable for use as a surgical graft. The substrate is suspended in the blood flow of a blood vessel by an anchor which permits the substrate to freely move within the lumen of the vessel but is anchored by the tether to prevent the substrate from moving along the vessel in the direction of blood flow. The collagenous tissue growth about the substrate is generally tubular and suitable for use as a surgical graft.

The method of generating a homograft includes preparing a prosthesis composed of a tubular substrate. The substrate is open at each end to permit blood to flow along the length of the substrate inside wall. The substrate is selected to have at least one thrombogenic surface or a thrombogenic mesh material supported by the substrate. The prosthesis is inserted in the lumen of a blood vessel, either a vein or artery, of a living body and anchored in the lumen of the vessel to prevent the substrate from moving along the vessel with the blood flow. The body generates collagenous growth on the thrombogenic surface of the substrate while the substrate is freely suspended in the blood flow of the vessel. The substrate is then removed from the vessel after which a tubular homograft of collagenous tissue is removed from the substrate.

Claims

1. A prosthetic device for promoting controlled collagenous tissue growth when suspended in the lumen of a blood vessel in the presence of blood flow which comprises:

(a) Tubular substrate means having a generally cylindrical outside surface and a generally cylindrical inside surface terminating at first and second open ends to permit blood flow along said inside surface,

(b) At least one of said surfaces being a thrombogenic surface to promote growth of collagenous tissue along such thrombogenic surface and

(c) Tether means for positioning the tubular substrate means within the lumen so as to allow fluid flow within the lumen to contact both the inside and outside surfaces of the tubular substrate means, said tether means having a first attachment to the substrate means and a second attachment, spaced apart from the first attachment, for attaching to the lumen.

2. A device in accordance with claim 1 in which said substrate means is made from polyurethane.

3. A device in accordance with claim 1 in which said thrombogenic surface is said inside surface.

4. A device in accordance with claim 1 in which said thrombogenic surface is said outside surface.

5. A device in accordance with claim 1 in which said tether means is a flexible tether.

6. A prosthesis for promoting controlled collagenous tissue growth when suspended in the lumen of a vessel in the presence of blood flow which comprises:

(a) Tubular substrate means having a generally cylindrical outside surface and a generally cylindrical inside surface terminating at first and second open ends to permit blood flow along said inside surface,

(b) Said inside and outside surfaces being thrombogenic to promote growth of collagenous tissue along such thrombogenic surfaces, and

(c) Tether means for positioning the tubular substrate means within the lumen so as to allow fluid flow within the lumen to contact both the inside and outside surfaces of the tubular substrate means, said tether means having a first attachment to the substrate means and a second attachment, spaced apart from the first attachment, for attaching to the lumen.

7. A device for promoting controlled collagenous tissue growth when suspended in the lumen of a vessel in the presence of blood flow which comprises:

(a) A tube of thrombogenic mesh material,

(b) Tubular substrate means for supporting said mesh material, said tubular substrate means having a generally cylindrical outside surface and a generally cylindrical inside surface terminating at first and second open ends to permit blood flow along said mesh material extending from said first end to said second end of said substrate means,

(c) Contact means at said first and second ends for connecting said tube of mesh material at each end of said substrate means to immobilize said mesh material between said first and second ends, and

(d) Tether means for positioning the tubular substrate means within the lumen so as to allow fluid flow within the lumen to contact both the inside and outside surfaces of the tubular substrate means, said tether means having a first attachment to the substrate means and a second attachment, spaced apart from the first attachment, for attaching to the lumen.

8. A device in accordance with claim 7 in which said mesh material is selected from a group consisting of Dacron, monofilament nylon, silicon polyester fiber, silk, or polypropylene.

9. A device in accordance with claim 7 in which said tether means is a flexible tether.

10. A device in accordance with claim 9 in which said tether is made of a material selected from the group consisting of Dacron braid, monofilament nylon braid, silicon polyester fiber braid, silk braid or polypropelene braid.

11. A device in accordance with claim 7 in which said substrate is polyurethane.

12. A device in accordance with claim 7 in which said mesh material extends from said first end to said second end of said substrate means to enclose said substrate means generally along said outside surface.

13. A device in accordance with claim 12 in which said mesh is connected at said first and second ends to provide a loose fit of said mesh over said outside surface to permit blood flow between said mesh material and said outside surface.

14. A device in accordance with claim 7 in which said mesh material extends from said first end to said second end along said inside surface and in which said mesh is stretched along a longitudinal axis through said first and second ends to position the mesh along the length of said inside surface generally out of contact with said inside surface.

15. A device in accordance with claim 7 in which said substrate is composed of a non-thrombogenic material.

16. A device in accordance with claim 15 in which said substrate is composed of a non-thrombogenic material selected from the group consisting of carbon, cardiothane, avcothane, coated material, albumin coated material and polyurethane.

17. A device in accordance with claim 7 in which said substrate is coated on said outside and inside surfaces with a non-thrombogenic coating.

18. A device in accordance with claim 17 in which said coating is carbon coated.