Implantable vascular device

• US 20040210301A1
• Filed: 11/25/2003
• Published: 10/21/2004
• Est. Priority Date: 02/03/2000
• Status: Active Grant

• Current Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Biotech Incorporated (Cook Group Incorporated)
• Inventors: Obermiller, Joseph F.
• Granted Patent: US 7,597,710 B2
• Time in Patent Office: Days
• US Class Current: 623/1.24
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0026 trapezoidal
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0058 X-shaped
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A multiple-sided medical device comprises a frame comprising wire or other resilient material and having a series of bends and interconnecting sides. The device has both a flat configuration and a second, folded configuration which a generally serpentine shape. The device is pushed from a delivery catheter into the lumen of a duct or vessel and may include one or more barbs for anchoring purposes. A full or partial covering of fabric or other flexible material such as DACRON, PTFE, or a collagen-based material such as small intestinal submucosa (SIS), may be sutured or attached to the frame using heat or pressure welding crimping, adhesive, or other techniques to form an occlusion device, a stent graft, or an implantable, intraluminal valve such as for correcting incompetent veins in the lower legs and feet.

Claims

1. An expandable implantable valve prosthesis, comprising:

a support frame supporting one or more leaflets, each leaflet comprising a biomaterial, the support frame and the one or more leaflets together functional as a valve to restrict blood flow in a first direction when implanted in the vascular vessel; and

wherein the biomaterial is folded over the support frame and attached to itself, thereby securing the one or more leaflets to the support frame.

2. The implantable valve of claim 1, wherein a cross-linking agent provides the attachment of the biomaterial to itself.

3. The implantable valve of claim 1, wherein an adhesive provides the attachment of the biomaterial to itself.

4. The implantable valve of claim 1, wherein welding provides the attachment of the biomaterial to itself.

5. The implantable valve of claim 4, wherein a heat source provides the weld that attaches the biomaterial to itself.

6. The implantable valve of claim 1, wherein the application of pressure provides the attachment of the biomaterial to itself.

7. An implantable valve prosthesis, comprising:

a support frame supporting one or more leaflets, each comprising a biomaterial, the one or more leaflets including a body, an inner edge, and an outer edge;

wherein the support frame and the one or more leaflets together functional as a valve to restrict blood flow in a first direction when implanted in the vascular vessel; and

wherein the leaflet outer edge is folded over the support frame with the outer edge or portion adjacent thereto being attached to the leaflet body by a non-suturing method that include at least one of the group consisting of cross-linking agents, adhesives, pressure welding, crimping, and heat welding, thereby securing the one or more leaflets to the support frame.

8. The implantable valve of claim 7, wherein the method includes heat to attach the biomaterial to itself.

9. The implantable valve of claim 7, wherein the method includes pressure to attach the biomaterial to itself.

10. An implantable vascular valve, comprising:

a support frame;

one or more leaflets comprised of biomaterial attached to the support frame and configured to function as a valve; and

wherein the biomaterial is wrapped around the support frame and welded to itself, thereby securing the one or more leaflets to the support frame.

11. An implantable vascular valve, comprising:

a support frame;

one or more leaflets comprised of biomaterial attached to the support frame and configured to function as a valve; and

wherein the biomaterial is wrapped around the support frame and affixed to itself using an adhesive, thereby securing the one or more leaflets to the support frame.

12. An implantable vascular valve, comprising:

a support frame;

one or more leaflets comprised of biomaterial attached to the support frame and configured to function as a valve; and

wherein the biomaterial is wrapped around the support frame and affixed to itself using the application of pressure, thereby securing the one or more leaflets to the support frame.

13. An expandable implantable vascular valve, comprising:

a support frame having a wall-engaging outer edge;

one or more leaflets comprised of biomaterial attached to the support frame and configured to function as a valve; and

wherein the outer wall-engaging edge of the support frame is enclosed by at two layers of the biomaterial attached to one another by a non-suturing method that include at least one of the group consisting of cross-linking agents, adhesives, pressure welding, crimping, and heat welding, thereby securing the one or more leaflets to the support frame.