Vascular prosthesis

• US 8,808,363 B2
• Filed: 08/31/2012
• Issued: 08/19/2014
• Est. Priority Date: 08/31/2012
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Perry, Michael David, Matheny, Robert G.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/573,226
• Publication Number:
  US 20140067046A1
• Time in Patent Office: 718 Days
• Field of Search: 623/1.36, 623/1.35, 606/232, 606/213
• US Class Current: 623/1.36
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2230/0095 Saddle-shaped
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof

Abstract

A vascular prosthesis comprising a tubular shaped expandable ECM member and at least one anchoring mechanism. In one embodiment, the anchoring mechanism comprises proximal and distal single or dual-ring anchors. In one embodiment, the anchoring mechanism comprises a multiple-ring anchor. The anchors preferably comprise a biodegradable metal, such as magnesium. The anchors can also comprise a shape memory alloy, such as nitinol, and a cross-linked ECM material. In some embodiments, the ECM member includes a pharmacological agent.

Claims

1. An implantable extracellular matrix (ECM) vascular prosthesis, comprising:

an expandable tubular ECM member comprising a remodelable ECM material from a mammalian tissue source, said ECM member further comprising an interior and exterior surface, and proximal and distal ends, said interior surface defining a conduit through said ECM member, said conduit providing unrestricted fluid flow through said ECM member,

said ECM member being capable of transitioning from a tubular member pre-deployment configuration, wherein said ECM member is capable of being positioned at a target position within a cardiovascular vessel, said cardiovascular vessel comprising host cardiovascular tissue having a first tissue temperature,

to a tubular member post-deployment configuration, wherein at least a portion of said ECM member exterior surface is disposed proximate said host cardiovascular tissue of said cardiovascular vessel,

said ECM member further comprising first and second expandable biocompatible anchors, said first expandable anchor being secured on said ECM member proximal end and proximate said ECM member interior surface, said second expandable anchor being secured on said ECM member distal end and proximate said ECM member interior surface,

said first and second anchors being capable of transitioning from an anchor pre-deployment configuration at a first anchor temperature, wherein said ECM member is configured in said ECM member pre-deployment configuration, to an anchor post-deployment configuration when said ECM member is disposed in said cardiovascular vessel and subjected to said host cardiovascular tissue temperature, wherein said ECM member is configured in said ECM member post-deployment configuration and, wherein said first and second anchors position said ECM member exterior surface at said proximal and distal ends adjacent said host cardiovascular tissue of said cardiovascular vessel and maintain contact of said ECM member exterior surface at said proximal and distal ends to said host cardiovascular tissue of said cardiovascular tissue for a first temporary anchor support period of time.

2. The ECM vascular prosthesis of claim 1, wherein said mammalian tissue source is selected from the group consisting of the small intestine, large intestine, stomach, lung, liver, kidney, pancreas, placenta, heart, bladder, prostate, tissue surrounding growing enamel, tissue surrounding growing bone, and fetal tissue from a mammalian organ.

3. The ECM vascular prosthesis of claim 1, wherein said ECM member include one layer of said ECM material.

4. The ECM vascular prosthesis of claim 1, wherein said ECM member includes multiple layers of said ECM material.

5. The ECM vascular prosthesis of claim 1, wherein said first temporary anchor support period of time is within the process of cardiovascular tissue regeneration.

6. The ECM vascular prosthesis of claim 5, wherein said first temporary anchor support period of time is within the range of 12-36 months.

7. The ECM vascular prosthesis of claim 5, wherein said first temporary anchor support period of time is within the range of 3-12 months.

8. The ECM vascular prosthesis of claim 5, wherein said first temporary anchor support period of time is within the range of 1-3 months.

9. The ECM vascular prosthesis of claim 1, wherein said first and second anchors comprise a biocompatible shape memory alloy.

10. The ECM vascular prosthesis of claim 9, wherein said biocompatible shape memory alloy comprises Nitinol®

.

11. The ECM vascular prosthesis of claim 1, wherein said first and second anchors comprise a single anchor ring.

12. The ECM vascular prosthesis of claim 1, wherein said first and second anchors exert a supporting force on said ECM member proximal and distal ends in the range of approximately 0.5-2.0 atm when said first and second anchors are in said post-deployment configuration.

13. The ECM vascular prosthesis of claim 12, wherein said supporting force diminishes to approximately 0 after said first temporary anchor support period of time.