# US 9,433,491 B1 · Tissue prostheses for repairing, reconstructing and replacing damaged or diseased biological structures and associated tissue

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,433,491 B1
- Document ID: US9433491B1
- Status: Granted
- Kind: B1
- Application number: 15/144,902
- Filed: 2016-05-03
- Published: 2016-08-25
- Granted: 2016-09-06
- Earliest claimed: 2014-07-22
- Assignees: CorMatrix Cardiovascular, Inc.
- Applicants: CorMatrix Cardiovascular, Inc.
- Inventors: Robert G Matheny
- Web page: https://patentgrep.com/patent/US9433491B1

## CPC

- A61F 2/04: Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts (A61F2/18, A61F2/20 take precedence; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95)
- A61F 2/06: Blood vessels
- A61F 2/24: Heart valves {; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body}
- A61L 27/28: Materials for coating prostheses
- A61L 27/34: Macromolecular materials
- A61L 27/36: containing ingredients of undetermined constitution or reaction products thereof {, e.g. transplant tissue, natural bone, extracellular matrix (isolated natural compounds, e.g. collagen A61L27/24)}
- A61L 27/3625: {Vascular tissue, e.g. heart valves}
- A61L 27/3629: {Intestinal tissue, e.g. small intestinal submucosa}
- A61L 27/3633: {Extracellular matrix [ECM]}
- A61L 27/38: {containing added animal cells (organs or tissue containing native cells A61L27/36)}
- A61L 27/3834: {Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 27/58: Materials at least partially resorbable by the body
- A61F 2002/041: {Bile ducts}
- A61F 2002/043: {Bronchi}
- A61F 2002/044: {Oesophagi or esophagi or gullets}
- A61F 2002/045: {Stomach, intestines}
- A61F 2002/046: {Tracheae}
- A61F 2002/047: {Urethrae}
- A61F 2002/048: {Ureters}
- A61L 2300/40: characterised by a specific therapeutic activity or mode of action
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2300/414: Growth factors
- A61L 2300/606: Coatings
- A61L 2300/64: Animal cells
- A61L 2430/20: for reconstruction of the heart, e.g. heart valves
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)

## Abstract

Non-antigenic, bioremodelable tissue prostheses that can be engineered into a variety of shapes and used to repair, augment, reconstruct or replace damaged or diseased biological structures and associated tissue.

## Claims

### Claim 1

A method for reconstructing and replacing damaged biological structures and tissue, comprising the steps of:
providing a tissue prosthesis comprising a seamless tubular member, said seamless tubular member comprising a decellularized mammalian tubular structure, said tubular structure having a first length, proximal and distal ends, an outer surface and a lumen that extends therethrough,
said mammalian tubular structure further comprising at least one coating, said coating comprising poly(glycerol sebacate) (PGS), said PGS coating being disposed on at least a portion of said tubular structure outer surface,
said coated mammalian tubular structure being configured to induce modulated healing when said tubular member is disposed proximate damaged biological tissue of a biological structure, said modulated healing comprising modulation of inflammation of said damaged tissue, host tissue proliferation, bioremodeling of said damaged tissue, and regeneration of new tissue and tissue structures with site-specific structural and functional properties; and
disposing said tissue prosthesis proximate said damaged biological tissue of said biological structure, wherein said tubular member induces modulated healing of said damaged biological tissue and biological structure.

### Claim 2 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure comprises a segment of a mammalian structure selected from the group consisting of mammalian intestine, umbilical artery and vein, ureter, mesenteric vessel and jugular vein.

### Claim 3 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure comprises a segment of adolescent small intestine.

### Claim 4 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure further comprises at least a first exogenously added biologically active agent.

### Claim 5 (depends on 4)

The method of claim 4, wherein said first biologically active agent comprises a growth factor selected from the group consisting of transforming growth factor-beta (TGF-β), and basic fibroblast growth factor (bFGF).

### Claim 6 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure further comprises a statin selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.

### Claim 7 (depends on 1)

The method of claim 1, wherein said coating comprises an extracellular matrix (ECM) composition comprising an ECM material selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), stomach submucosa (SS), liver basement membrane (LBM), intact basement membrane, placental extracellular matrix, omentum extracellular matrix, cardiac extracellular matrix, kidney extracellular matrix, pancreas extracellular matrix, lung extracellular matrix, and combinations thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure further comprises reinforcement means.

### Claim 9 (depends on 1)

The method of claim 1, wherein said mammalian tubular structure further comprises at least one anchoring mechanism.