# US 2019/0167959 A1 · Bio-artificial pancreas for type ii diabetes intervention with no need of immunosuppression

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- Number: US 2019/0167959 A1
- Document ID: US20190167959A1
- Status: Published application
- Kind: A1
- Application number: 15/828,860
- Filed: 2017-12-01
- Published: 2019-06-06
- Earliest claimed: 2017-12-01
- Inventors: Taylor G. Wang
- Web page: https://patentgrep.com/patent/US20190167959A1

## CPC

- A61M 31/002: {Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time (artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50)}
- A61F 2/022: {Artificial gland structures using bioreactors (hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36)}
- A61L 27/047: {Other specific metals or alloys not covered by A61L27/042 - A61L27/045 or A61L27/06}
- A61L 27/26: Mixtures of macromolecular compounds
- A61L 27/3604: {characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel}
- A61L 27/3804: {characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells}
- A61L 27/50: Materials characterised by their function or physical properties {, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials}
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61M 2205/04: implanted
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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

A vascularized bio-artificial pancreas for managing diabetes may include a capsule having a semi-permeable interwoven capsular membrane with tapered conduits, wherein the tapered conduits are smaller in diameter proximate to an outer surface of the semi-permeable capsular membrane and larger in diameter proximate to an inner surface of the semi-permeable capsular membrane; a capsular bead encasing a plurality of the capsules; and a capsular pouch encasing the capsular bead and designed to anchor the capsular bead to a transplantation recipient.

## Claims

### Claim 1

A vascularized bio-artificial pancreas for managing diabetes, the vascularized bio-artificial pancreas comprising:
a capsule having a semi-permeable interwoven capsular membrane with tapered conduits, wherein the tapered conduits are smaller in diameter proximate to an outer surface of the semi-permeable capsular membrane and larger in diameter proximate to an inner surface of the semi-permeable capsular membrane;
a capsular bead encasing a plurality of the capsules; and
a capsular pouch encasing the capsular bead and designed to anchor the capsular bead to a transplantation recipient.

### Claim 2 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the semi-permeable capsular membrane comprises a plurality of membrane layers.

### Claim 3 (depends on 2)

The vascularized bio-artificial pancreas of claim 2, wherein comprises the following membrane layers in order from the outer surface to the inner surface:
a polymethylene-co-guanidine (PMCG)-cellulose sulfate (CS)/poly L-lysine (PLL)-Alginate (Alg) layer; and
a PMCG-CS/Ca-Alg layer.

### Claim 4 (depends on 3)

The vascularized bio-artificial pancreas of claim 3, wherein:
the PMCG-CS/PLL-Alg layer comprises pores having a diameter of about 15 nm; and
the PMCG-CS/CA-Alg layer comprises larger pores with a diameter of from about 20 to about 30 nm.

### Claim 5 (depends on 3)

The vascularized bio-artificial pancreas of claim 3, wherein the capsules comprise:
about 1 to about 2% alginate;
about 0.6 to about 1.2% cellulose sulfate;
about 0.5 to about 1.0% PMCG;
about 0.025 to about 0.05% PLL; and
about 1 to about 3% CaCl2).

### Claim 6 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the capsular bead has a diameter of about 2 to 3 mm.

### Claim 7 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the capsular bead contains about 2 to about 4 capsules encased therein.

### Claim 8 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the vascularized bio-artificial pancreas comprises a plurality of capsular pouches, each capsular pouch encasing a plurality of capsular beads:
about 30,000 islets for intraperitoneal transplantations; and
about 5,000 islets for subcutaneous transplantations.

### Claim 9 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the capsular bead comprises:
about 0.5 to about 1% alginate;
about 0.3 to about 0.6% cellulose sulfate; and
about 1 to about 3% CaCl2).

### Claim 10 (depends on 1)

The vascularized bio-artificial pancreas of claim 1, wherein the capsular pouch comprises:
about 0.5 to about 1% alginate; and
about 1 to about 3% CaCl2).
