# US 11,077,289 B2 · 3-dimensional large capacity cell encapsulation device assembly

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- Number: US 11,077,289 B2
- Document ID: US11077289B2
- Status: Granted
- Kind: B2
- Application number: 15/349,787
- Filed: 2016-11-11
- Published: 2017-04-27
- Granted: 2021-08-03
- Earliest claimed: 2013-03-07
- Assignees: ViaCyte, Inc.
- Applicants: ViaCyte, Inc.
- Inventors: Vincent So; Laura Martinson; Chad Green; Michael Scott; Mario Zamarripa
- Web page: https://patentgrep.com/patent/US11077289B2

## 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)}
- A61P 3/10: for hyperglycaemia, e.g. antidiabetics
- A61M 2202/09: Body tissue
- 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)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

Disclosed herein are implantable 3-dimensional large capacity device assemblies, specifically, large capacity device assemblies for encapsulating pancreatic progenitor cells for treatment of diabetes.

## Claims

### Claim 1

A foldable cell encapsulating assembly, said assembly comprising at least two planar cell chambers and a cell-free region along the longest axis separating the at least two planar cell chambers, wherein each chamber comprises a semi-permeable membrane and the first chamber is completely sealed from the second chamber, and wherein the cell-free region comprises a bendable region interconnecting the at least two planar cell chambers, wherein the semi-permeable membrane of each chamber has an inner surface configured to be in contact with cells that are placed in the respective chamber, wherein each chamber is configured to be sealed to contain the cells that are placed in the respective chamber, and wherein at least a portion of an outer surface of the cell encapsulating assembly is configured to be placed in direct contact with host tissue upon implantation of the cell encapsulating assembly into a mammalian host, wherein the assembly is shape set to have a corrugated configuration in which the at least two planar cell chambers are spaced apart from each other by the bendable region.

### Claim 2 (depends on 1)

The assembly of claim 1, wherein each of the at least two planar cell chambers comprise definitive endoderm-lineage cells.

### Claim 3 (depends on 2)

The assembly of claim 2, wherein the definitive endoderm-lineage cells are human pancreatic and duodenal homeobox gene 1 (PDX1)-positive pancreatic progenitor cells.

### Claim 4 (depends on 2)

The assembly of claim 2, wherein the definitive endoderm-lineage cells are human endocrine precursor cells.

### Claim 5 (depends on 1)

The assembly of claim 1, wherein the semi-permeable membrane is perforated.

### Claim 6 (depends on 1)

The assembly of claim 1, wherein the assembly comprises at least three, four, five, six, seven, eight or more cell chambers.

### Claim 7 (depends on 1)

The assembly of claim 1, wherein each of the at least two planar cell chambers comprises at least one loading port.

### Claim 8 (depends on 1)

The assembly of claim 1, wherein each of the at least two planar cell chambers comprises at least two loading ports.

### Claim 9 (depends on 1)

The assembly of claim 1, wherein each chamber comprises two semi-permeable membranes on opposite sides of the chamber and the assembly further comprises a first layer of semipermeable material and a second layer of semipermeable material, wherein a first portion of the first layer and an opposing first portion of the second layer form the two semipermeable membranes on opposites sides of one of the at least two planar cell chambers, wherein a second portion of the first layer and an opposing second portion of the second layer form the two semipermeable membranes on opposites sides of the other of the at least two planar cell chambers, and wherein the first and second layers are secured to each other between the at least two planar cell chambers to form the cell-free region.

### Claim 10 (depends on 9)

The assembly of claim 9, wherein the cell-free region comprises a welded region bonding the first and second layers to each other.

### Claim 11 (depends on 10)

The assembly of claim 10, wherein the welded region extends between and intersects first and second opposing edges of the assembly that extend perpendicular to the longest axis.

### Claim 12 (depends on 1)

The assembly of claim 1, wherein the cell chambers are substantially parallel to each other.

### Claim 13 (depends on 1)

The assembly of claim 1, wherein each cell chamber is separated from an adjacent cell chamber by about 20 degrees.

### Claim 14 (depends on 1)

The assembly of claim 1, wherein each cell chamber is separated from an adjacent cell chamber by about 40 degrees.

### Claim 15 (depends on 1)

The assembly of claim 1, wherein each cell chamber is separated from an adjacent cell chamber by about 5, about 10, about 15, about 20, about 25, about 30, about 35, about 40, about 45, about 50, about 55, about 60, about 65, about 70, about 75, about 80, about 85, about 90, about 95, about 100, about 105, about 110, about 115, about 120, about 125, about 130, about 135, about 140, about 145, about 150, about 155, about 160, about 165, about 170, about 175, or less than 180 degrees.

### Claim 16 (depends on 1)

The assembly of claim 1, wherein each cell chamber is separated from an adjacent cell chamber by about 0 degrees.

### Claim 17

A foldable cell encapsulating assembly, said assembly comprising at least two planar cell chambers and a cell-free region along the longest axis separating the at least two planar cell chambers, wherein each chamber comprises a semi-permeable membrane and the first chamber is completely sealed from the second chamber, and wherein the cell-free region comprises a bendable region interconnecting the at least two planar cell chambers, wherein each chamber includes a volume of cells and is sealed to contain the volume of cells in the respective chamber, wherein the semi-permeable membrane of each chamber has an inner surface in contact with the cells in the respective chamber, and wherein at least a portion of an outer surface of the cell encapsulating assembly is configured to be placed in direct contact with host tissue upon implantation of the cell encapsulating assembly into a mammalian host, wherein the assembly is shape set to have a corrugated configuration in which the at least two planar cell chambers are spaced apart from each other by the bendable region, and wherein the semi-permeable membrane is perforated.

### Claim 18

A foldable cell encapsulating assembly, said assembly comprising at least two planar cell chambers and a cell-free region along the longest axis separating the at least two planar cell chambers, wherein each chamber comprises a semi-permeable membrane and the first chamber is completely sealed from the second chamber, and wherein the cell-free region comprises a bendable region interconnecting the at least two planar cell chambers, wherein the semi-permeable membrane of each chamber has an inner surface configured to be in contact with cells that are placed in the respective chamber, wherein each chamber comprises at least one loading port configured to be sealed to contain the cells that are placed in the respective chamber, and wherein at least a portion of an outer surface of the cell encapsulating assembly is configured to be placed in direct contact with host tissue upon implantation of the cell encapsulating assembly into a mammalian host, wherein the assembly is shape set to have a corrugated configuration in which the at least two planar cell chambers are spaced apart from each other by the bendable region.

### Claim 19 (depends on 18)

The assembly of claim 18, wherein the at least two planar cell chambers comprise more than two planar cell chambers and the cell-free region comprises a plurality of cell-free, bendable regions, each of which interconnects a pair of adjacent planar cell chambers, wherein the plurality of cell-free, bendable regions comprises a cell-free, bendable region that is bent in a first direction and a cell-free, bendable region that is bent in a second direction, opposite the first direction.

### Claim 20 (depends on 19)

The assembly of claim 19, comprising a plurality of bendable regions that are bent in the first direction, and a plurality of bendable regions that are bent in the second direction, wherein the plurality of bendable regions that are bent in the first direction and the plurality of bendable regions that are bent in the second direction alternate direction along a width of the assembly.

### Claim 21 (depends on 18)

The assembly of claim 18, wherein the semi-permeable membrane is perforated.
