# US 2024/0189484 A1 · Composite decellularized matrix membrane and use thereof

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- Number: US 2024/0189484 A1
- Document ID: US20240189484A1
- Status: Published application
- Kind: A1
- Application number: 18/177,530
- Filed: 2023-03-02
- Published: 2024-06-13
- Earliest claimed: 2022-12-08
- Assignees: Shines Biotechnology Co., Ltd
- Applicants: Shines Biotechnology Co., Ltd
- Inventors: Nisi ZHANG; Dahong ZHANG; Wei WEI; Yi HONG; Shuai WANG; Pu ZHANG; Haibo TAN; Yidan ZHANG
- Web page: https://patentgrep.com/patent/US20240189484A1

## CPC

- A61L 27/44: having a macromolecular matrix
- A61L 27/18: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
- A61L 27/362: {Skin, e.g. dermal papillae}
- A61L 27/3629: {Intestinal tissue, e.g. small intestinal submucosa}
- A61L 27/3679: {Hollow organs, e.g. bladder, esophagus, urether, uterus, intestine}
- A61L 27/3687: {characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents}
- A61L 27/58: Materials at least partially resorbable by the body
- A61L 2300/41: Anti-inflammatory agents, e.g. NSAIDs
- A61L 2400/02: Treatment of implants to prevent calcification or mineralisation in vivo
- A61L 2420/02: Methods for coating medical devices
- A61L 2430/22: for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
- A61L 2430/40: Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
- 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

The present disclosure provides a composite decellularized matrix membrane and use thereof. The composite decellularized matrix membrane prepared by the present disclosure is prepared by wrapping one layer of a polymer membrane with two layers of decellularized matrix membranes. The decellularized matrix membrane is prepared from at least a biomaterial of a porcine small intestine, a porcine bladder, and porcine skin. The polymer membrane is prepared from at least a polymer material of polycaprolactone, polydimethylsiloxane, polyurethane, polylactic acid-glycolic acid, polyvinyl alcohol, and polyhydroxy fatty acid ester. The composite decellularized matrix membrane prepared by the present disclosure can prevent calculi, makes a patient suffer less, recover faster, live better, and cost less, while medical resources are saved, and hope for treatment is also brought for some patients with a contraindication to an in-situ ileal neobladder surgery.

## Claims

### Claim 1

A composite decellularized matrix membrane, comprising a decellularized matrix membrane and a polymer membrane, wherein the composite decellularized matrix membrane comprises two layers of the decellularized matrix membranes and one layer of the polymer membrane, and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes.

### Claim 2 (depends on 1)

The composite membrane according to claim 1, wherein the decellularized matrix membrane is prepared from a biomaterial of a porcine small intestine, a porcine bladder, and porcine skin.

### Claim 3 (depends on 2)

The composite membrane according to claim 2, wherein the polymer membrane is prepared from a polymer material of polycaprolactone, polylactic acid, and polyurethane.

### Claim 4 (depends on 2)

The composite membrane according to claim 2, wherein the decellularized matrix membrane is prepared from a submucosa of a porcine small intestine.

### Claim 5 (depends on 4)

The composite membrane according to claim 4, wherein the polymer membrane is prepared from polycaprolactone and the composite membrane is usable for preparing an absorbably degradable and good-toughness artificial bladder capable of preventing calculi, water infiltration, and inflammation.

### Claim 6 (depends on 4)

The composite membrane according to claim 4, wherein the polymer membrane is prepared from polylactic acid and the composite membrane is usable for preparing an absorbably degradable artificial bladder capable of preventing calculi and water infiltration.

### Claim 7 (depends on 4)

The composite membrane according to claim 4, wherein the polymer membrane is prepared from polyurethane.

### Claim 8 (depends on 4)

The composite membrane according to claim 4, wherein the polymer membrane is prepared from at least one polymer material of polydimethylsiloxane, polylactic acid-glycolic acid, polyvinyl alcohol, and polyhydroxy fatty acid ester, and wherein the composite membrane is usable for preparing an artificial bladder with a good toughness.

### Claim 9 (depends on 4)

The composite membrane according to claim 4, wherein the polymer membrane is prepared from at least one polymer material of polydimethylsiloxane, polylactic acid-glycolic acid, polyvinyl alcohol, and polyhydroxy fatty acid ester, and wherein the composite membrane is usable for preparing an artificial bladder capable of preventing inflammation.

### Claim 10 (depends on 4)

The composite membrane according to claim 4, wherein the decellularized matrix membrane is prepared by the following steps:
(1) physically treating a porcine small intestine and removing an adhesive substance of a submucosa to obtain the submucosa;
(2) immersing the obtained submucosa of the porcine small intestine in a decellularizing solution (adding 10 mL of Triton and 1 mL of ammonium hydroxide to 1,000 mL of deionized water) and placing the submucosa in a refrigerator at 4° C. for oscillating at 100 rpm for 12 h;
(3) after rinsing with a large amount of deionized water, placing the submucosa in 1 L of a degreasing solution (methanol/chloroform=1:1) for soaking for 24 h;
(4) after rinsing with deionized water, placing the submucosa in 1 L of anhydrous ethanol for oscillating and soaking for 24 h and fully extracting residual methanol/chloroform to obtain a prepared decellularized matrix membrane of the submucosa of the porcine small intestine; and
(5) finally repeatedly washing the obtained decellularized matrix membrane with deionized water and freeze-drying, sealing, and storing the decellularized matrix membrane in a refrigerator at 4° C.

### Claim 11 (depends on 4)

The composite membrane according to claim 4, wherein the composite decellularized matrix membrane is prepared by the following steps:
(1) weighing a polymer material, putting the same into a solvent, and shaking the solution until completely dissolved in a dark place at a room temperature to obtain a polymer solution;
(2) after completely soaking the decellularized matrix membrane with water, laying the membrane on a surface of a spherical mold, and placing the membrane in a ventilated place until water on a surface of the membrane is evaporated;
(3) coating the polymer solution on the surface of the decellularized matrix membrane after the water on the surface is evaporated, so as to obtain the decellularized matrix membrane with the polymer membrane; and
(4) after the solvent is completely volatilized, completely soaking another decellularized matrix membrane, laying the same on the decellularized matrix membrane with the polymer membrane, and after the membrane is completely dried, taking out the mold to obtain the composite decellularized matrix membrane.

### Claim 12

An artificial bladder, wherein the artificial bladder comprises a composite decellularized matrix membrane, the composite membrane comprises a decellularized matrix membrane and a polymer membrane, the composite decellularized matrix membrane comprises two layers of the decellularized matrix membranes and one layer of the polymer membrane, and the one layer of the polymer membrane is located between the two layers of the decellularized matrix membranes.

### Claim 13 (depends on 12)

The artificial bladder according to claim 12, wherein the decellularized matrix membrane is prepared from at least a biomaterial of a porcine small intestine, a porcine bladder, and porcine skin.

### Claim 14 (depends on 13)

The artificial bladder according to claim 13, wherein the polymer membrane is prepared from at least a polymer material of polycaprolactone, polylactic acid, and polyurethane.

### Claim 15 (depends on 14)

The artificial bladder according to claim 14, wherein the decellularized matrix membrane is prepared from a submucosa of a porcine small intestine.

### Claim 16 (depends on 15)

The artificial bladder according to claim 15, wherein the polymer membrane is prepared from polycaprolactone.

### Claim 17 (depends on 15)

The artificial bladder according to claim 15, wherein the polymer membrane is prepared from polyurethane.

### Claim 18 (depends on 13)

The artificial bladder according to claim 13, wherein the polymer membrane is prepared from at least a polymer material of polydimethylsiloxane, polyurethane, polylactic acid-glycolic acid, polyvinyl alcohol, and polyhydroxy fatty acid ester.

### Claim 19 (depends on 18)

The artificial bladder according to claim 18, wherein the polymer membrane is prepared from polydimethylsiloxane.
