# US 2023/0053679 A1 · Bioartificial pancreas

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- Number: US 2023/0053679 A1
- Document ID: US20230053679A1
- Status: Published application
- Kind: A1
- Application number: 17/981,287
- Filed: 2022-11-04
- Published: 2023-02-23
- Earliest claimed: 2019-09-27
- Assignees: ISLA Technologies, Inc.
- Applicants: ISLA Technologies, Inc.
- Inventors: Sara Joan Photiadis; Douglas Marc Photiadis; Thomas A. Kramer
- Web page: https://patentgrep.com/patent/US20230053679A1

## CPC

- A61F 2/022: {Artificial gland structures using bioreactors (hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36)}
- A61F 2/07: Stent-grafts
- A61F 2/844: folded prior to deployment
- A61F 2/90: characterised by a net-like or mesh-like structure
- A61K 35/39: Pancreas; Islets of Langerhans (Langerhans cells of epidermis A61K35/36)
- A61L 27/56: Porous materials, {e.g. foams or sponges}
- A61L 31/005: {Ingredients of undetermined constitution or reaction products thereof}
- A61L 31/08: Materials for coatings
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- C12N 5/0678: {Stem cells; Progenitor cells; Precursor cells}
- A61F 2210/0004: bioabsorbable
- A61F 2210/0076: multilayered, e.g. laminated structures
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2240/002: Designing or making customized prostheses
- A61F 2250/0067: Means for introducing or releasing pharmaceutical products into the body
- A61L 2300/608: having two or more layers
- A61L 2300/64: Animal cells
- A61L 2420/08: Coatings comprising two or more layers
- C12N 2513/00: 3D culture
- 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)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

A bioartificial device, such as a bioartificial pancreas, for implantation in a patient's vascular system. The bioartificial pancreas includes a scaffold adapted to engage an interior wall of a blood vessel, a cellular complex support by the scaffold and extending longitudinally within the interior cavity of the scaffold so as to be exposed to the blood flow when the scaffold is engaged with the blood vessel, the cellular complex support comprising one or more pockets bordered by thin film; and cellular complex comprising pancreatic islets disposed in the one or more pockets, the thin film being adapted to permit oxygen and glucose to diffuse from flowing blood into the one or more pockets at a rate sufficient to support the viability of the islets. The invention also includes methods of making and using a bioartificial pancreas.

## Claims

### Claim 1

A method of preparing a bioartificial implant, the method comprising:
providing a bioartificial implant, which comprises:
a scaffold configured to engage an interior wall of a blood vessel of a subject, the scaffold comprising a blood flow lumen extending longitudinally through an interior cavity of the scaffold so as to permit blood flow therethrough when the scaffold is engaged with the blood vessel; and
a cellular complex support supported by the scaffold and extending longitudinally within the interior cavity of the scaffold so as to be exposed to the blood flow when the scaffold is engaged with the blood vessel, the cellular complex support comprising one or more pockets and a plurality of attachment regions attached to the scaffold, wherein the cellular complex support comprises two microporous thin film layers bordering the pockets and, wherein the cellular complex support is configured to permit nutrients to diffuse from flowing blood into the one or more pockets; and
providing a plurality of cells to said one or more pockets of the cellular complex support through an opening in said one or more pockets.

### Claim 2 (depends on 1)

The method of claim 1, wherein providing the plurality of cells to the one or more pockets comprises injecting the one or more pockets with the plurality of cells.

### Claim 3 (depends on 2)

The method of claim 2 wherein providing the plurality of cells to the one or more pockets comprises injecting the plurality of cells through a tube extending through an opening of the cellular complex support.

### Claim 4 (depends on 3)

The method of claim 3, further comprising withdrawing the tube.

### Claim 5 (depends on 4)

The method of claim 4, wherein withdrawing the tube comprises withdrawing the tube while injecting the plurality of cells.

### Claim 6 (depends on 3)

The method of claim 3, further comprising closing the opening in said one or more pockets.

### Claim 7 (depends on 6)

The method of claim 6, wherein closing the opening of the one or more pockets comprises heat sealing the opening or edges of the one or more pockets.

### Claim 8 (depends on 1)

The method of claim 1, further comprising providing a biocompatible material to the one or more pockets through said opening in said one or more pockets.

### Claim 9 (depends on 8)

The method of claim 8, further comprising mixing the plurality of cells with the biocompatible material to form a slurry.

### Claim 10 (depends on 1)

The method of claim 1, wherein the plurality of cells comprise pancreatic islets or stem cells.

### Claim 11 (depends on 1)

The method of claim 1 further comprising attaching the cellular complex support to the scaffold.

### Claim 12 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold is performed after providing the plurality of cells to the one or more pockets of the cellular complex support.

### Claim 13 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold is performed before providing the plurality of cells to the one or more pockets of the cellular complex support.

### Claim 14 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold comprises suturing the cellular complex support to the scaffold.

### Claim 15 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold comprises thermally bonding the cellular complex support to the scaffold.

### Claim 16 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold comprises pressure bonding the cellular complex support to the scaffold.

### Claim 17 (depends on 11)

The method of claim 11, wherein attaching the cellular complex support to the scaffold comprises attaching a plurality of attachment regions of the cellular complex support to the scaffold.

### Claim 18 (depends on 1)

The method of claim 1, wherein the cellular complex support comprises a layer of biocompatible material.

### Claim 19 (depends on 1)

The method of claim 1, wherein the two microporous thin film layers are configured to permit oxygen and glucose to diffuse to the plurality of cells within the one or more pockets.

### Claim 20 (depends on 1)

The method of claim 1, wherein at least a portion of the bioartificial implant is generated by 3D printing.
