Stent covered heterologous tissue

• US 6,468,300 B1
• Filed: 09/23/1997
• Issued: 10/22/2002
• Est. Priority Date: 09/23/1997
• Status: Expired due to Term

• Current Assignee: Amnis Therapeutics Ltd.
• Original Assignee: Diseno Y Desarrollo Medico SA de CV
• Inventors: Freidberg, Carlos Vonderwalde
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/935,784
• Time in Patent Office: 1,855 Days
• Field of Search: 606/194, 606/195, 606/153, 623/1, 623/1.13, 623/1.23, 623/2.14, 623/903, 623/23.72
• US Class Current: 623/1.13
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/903 Blood vessel

Abstract

A covered stent assembly comprising a tubular, expandable stent having a metallic framework covered with a cylinder of biocompatible, non-thrombogenic expandable material, such as heterologous tissue. In a preferred embodiment, the metallic framework is positioned coaxially within a cylinder of bovine pericardial tissue. A catheter may be used to deliver the stent assembly to a desired region in the lumen of a patient. The metallic framework is then expanded to seat the assembly within the lumen.

Claims

1. An intraluminal stent assembly, comprising an expandable metallic stent having a tubular structure with a first end, a second end, and a circumference configured to expand to a larger circumference from the first end to the second end of the stent, and disposed within a cylinder of biocompatible non-thrombogenic expandable heterologous tissue, the tissue cylinder having a first end with a circumference on the stent and a second end with a circumference on the stent, the tissue having a thickness of less than about 0.45 millimeters, and a first edge facing and abutting a second edge and secured thereto at a plurality of intermittent locations from the cylinder first end to the cylinder second end to form the cylinder, the intermittent secured locations being separated by unsecured portions of the first and second edges.

2. The stent assembly of claim 1, wherein the heterologous tissue is selected from the group consisting of bovine pericardium, porcine pericardium, and aortic leaflet.

3. The stent assembly of claim 1, wherein the heterologous tissue comprises bovine pericardium with cross-linked collagen.

5. The stent assembly of claim 1, wherein the heterologous tissue has a thickness of about 0.25 millimeters.

8. The stent assembly of claim 1 wherein the stent assembly has an outer surface and an inner surface, and the heterologous tissue cylinder forms the outer surface of the stent assembly, and the stent forms the inner surface of the stent assembly.

4. A method for maintaining the patency of a body lumen, comprising:

a) mounting an intraluminal stent on a catheter, the stent comprising a coaxial assembly of a tubular expandable, metallic framework within a cylinder of heterologous tissue having a first end and a second end, the stent being configured to expand with the tissue to an expanded configuration to seat the stent assembly within the body lumen, and the tissue having a first end, a second end, a thickness of less than about 0.45 millimeters, and a first edge facing and abutting a second edge and secured thereto at a plurality of intermittent locations from the cylinder first end to the cylinder second end to form the cylinder, the intermittent secured locations being separated by unsecured portions of the first and second edges;

b) advancing the catheter through the body lumen until the stent is positioned at a desired location;

c) expanding the stent to anchor it within the body lumen; and

d) withdrawing the catheter.

6. An intraluminal stent assembly, comprising

a) a cylinder of biocompatible non-thrombogenic expandable heterologous tissue having a first end with a diameter, a second end with a diameter equal to the diameter of the first end, and the tissue having a first edge facing and abutting a second edge from the cylinder first end to the cylinder second end to form the cylinder;

and

b) a stent disposed within the cylinder of heterologous tissue, having a first end and a second end, and configured to expand with the tissue to an expanded configuration from the first end to the second end of the stent, to seat the stent assembly within the body lumen.

7. The stent assembly of claim 6 wherein the first and second edges of the tissue are secured together from the tissue first end to the tissue second end.

9. The stent assembly of claim 6 wherein the stent assembly has an outer surface and an inner surface, and the heterologous tissue cylinder forms the outer surface of the stent assembly, and the stent forms the inner surface of the stent assembly.

10. An intraluminal stent assembly, comprising

a) a cylinder of pericardium having a first end with a diameter, a second end with a diameter equal to the diameter of the first end, and the tissue having a first edge facing and abutting a second edge from the cylinder first end to the cylinder second end to form the cylinder;

and

b) a stent disposed within the cylinder of pericardium, having a first end and a second end, and configured to expand with the pericardium to an expanded configuration from the first end to the second end of the stent, to seat the stent assembly within the body lumen.