Extracellular matrix material conduits and methods of making and using same

• US 8,845,719 B2
• Filed: 05/24/2012
• Issued: 09/30/2014
• Est. Priority Date: 05/27/2011
• Status: Active Grant

• Current Assignee: Cormatrix Cardiovascular, Inc.
• Original Assignee: Cormatrix Cardiovascular, Inc.
• Inventors: Matheny, Robert G.
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US13/480,347
• Publication Number:
  US 20120303117A1
• Time in Patent Office: 859 Days
• Field of Search: 623/2.13, 623/2.15, 623/2.19
• US Class Current: 623/2.13
• 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 2/2415 Manufacturing methods
• CPC Class Codes: A61L 2/0094 Gaseous substances
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• CPC Class Codes: A61L 27/3633 Extracellular matrix [ECM]
• CPC Class Codes: A61L 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• CPC Class Codes: A61L 27/3691 characterised by physical conditions of the treatment, e.g. applying a compressive force to the composition, pressure cycles, ultrasonic/sonication or microwave treatment, lyophilisation
• CPC Class Codes: A61L 27/3873 Muscle tissue, e.g. sphincter
• CPC Class Codes: A61L 27/3882 Hollow organs, e.g. bladder, esophagus, urether, uterus
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence

Abstract

Extracellular matrix (ECM) material conduits are disclosed. Methods for regenerating atrioventricular valves to replace defective atrioventricular valves within a heart of a subject using the ECM material conduits are also disclosed. Methods of sterilizing and decellularizing an ECM material are also disclosed.

Claims

1. An ECM valve conduit for regenerating an atrioventricular (AV) valve to replace a defective AV valve within a heart of a subject, the AV valve being attached to an annular region of the heart. the defective AV valve and annular region of the heart comprising first cardiovascular tissue, the defective AV valve further comprising a first plurality of valve leaflets, comprising:

a bioabsorbable tubular conduit member comprising sterile, acellular small intestine submucosa (SIS), said SIS comprising less than 4% DNA content and a dry weight bFGF content of at least 140 pg/mg of said SIS, said SIS further exhibiting at least 96% decellurization and a tensile strength of at least 9 N,

said ECM conduit member defining a lumen and having an inlet portion and an outlet portion, said inlet portion of said ECM conduit member being configured to attach to an said annular region of said heart of said subject, said outlet portion of said ECM conduit member being configured to attach to papillary muscles within said subject'"'"'s heart,

said ECM conduit member being configured to induce generation of a plurality of regenerated valve leaflets in said ECM conduit member lumen when said ECM conduit member is coupled to said first cardiovascular tissue of said annular region,

said plurality of regenerated valve leaflets comprising second cardiovascular tissue, said second cardiovascular tissue and said first cardiovascular tissue being similar, said plurality of regenerated valve leaflets being configured to function in a manner similar to said first valve leaflets of said defective AV valve.

2. The ECM valve conduit of claim 1, wherein said inlet portion and said outlet portion of said ECM conduit have respective outer circumferences, and wherein said outer circumference of said outlet portion is equal to said outer circumference of said inlet portion.

3. The ECM valve conduit of claim 1, wherein said outlet portion of said ECM conduit member includes a first extension portion and a second extension portion.

4. The ECM valve conduit of claim 3, wherein said first and second extension portions are spaced at 0°

and 120°

, respectively, on said ECM conduit member outlet portion.

5. The ECM valve conduit of claim 3, wherein said first and second extension portions are spaced at 0°

and 150°

, respectively, on said ECM conduit member outer portion.

6. The ECM valve conduit of claim 5, wherein at least a portion of said ECM conduit comprises a multi-laminate structure.