Cell encapsulation device

• US 5,902,745 A
• Filed: 05/21/1997
• Issued: 05/11/1999
• Est. Priority Date: 09/22/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Hybrid Technologies, Inc.
• Inventors: Drumheller, Paul D., Mish, Stanley L., Butler, Mark D.
• Primary Examiner(s): Beisner, William H.
• Application Number:
  US08/859,946
• Time in Patent Office: 720 Days
• Field of Search: 435/174, 435/182, 435/180, 435/382, 435/400, 435/401, 435/297.1, 435/297.2, 435/307.1, 435/309.1, 435/308.1, 435/309.2, 604/890.1, 604/891.1, 604/892.1, 424/424, 424/93.7
• US Class Current: 435/297.2
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: C12G 1/064 using enclosed yeast
• CPC Class Codes: C12M 23/08 Flask, bottle or test tube
• CPC Class Codes: C12M 23/22 Transparent or translucent parts glassware for laboratory use B01L3/00
• CPC Class Codes: C12M 23/34 Internal compartments or partitions
• CPC Class Codes: C12M 23/38 Caps; Covers; Plugs; Pouring means
• CPC Class Codes: C12M 25/16 Particles; Beads; Granular material; Encapsulation chemical or physical processes conducted in the presence of fluids and solid particles B01J8/00
• CPC Class Codes: C12M 33/14 with filters, sieves or membranes

Abstract

The present invention is directed to a cell encapsulation device that permits rapid and straightforward cell transfer into the device. The preferred device includes components that allow a user to quickly transfer cells into the device with minimal risk to the cells. Among the most important improvements of the present invention are: automatic filtration of excess solution during cell transfer; an instantly wettable cover, allowing ready view into the cell chamber; and a swellable core, allowing cells to be transferred with minimal shear force while assuring optimal cell placement in the device during use. The device of the present invention may be used either in vivo, such as to deliver therapeutic substances, or in vitro, such as to serve as a bioreactor.

Claims

1. A cell encapsulation device comprising:

A cell zone comprising a space delimited by a water wettable cover surrounding a cell displacing core within the cover;

wherein the cover has a coating thereon, the coating comprising a hydrophilic polymer material cross-linked to itself, wherein the cover is permeable to water and impermeable to cells such that the cover is a means to filter cells from solution upon introduction of cells and solution into the cell zone under a pressure less than about 6.9×

10⁵ Pa, thereby causing the solution to weep through the cover at a rate ranging from about 0.01 ml/cm² /minute to about 100 ml/cm² /minute while retaining the cells within the device;

wherein the core comprises a swellable material that expands form an initial first radial dimension to an enlarged second radial dimension upon exposure to an aqueous solution;

at least ne opening within the cover;

a cell delivery device to transfer cells into the device through the opening; and

means to seal the opening following introduction of cells into the device.

2. The cell encapsulation device of claim 1 wherein the cell delivery device comprises a tube mounted in the opening adapted to transfer cells from a separate vessel into the device.

3. The cell encapsulation device of claim 1 wherein the means to seal the opening comprises a constrictive device at the opening that contracts to seal the opening automatically upon removal of the cell delivery device from the opening.

4. The cell encapsulation device of claim 1 wherein the swellable material has a first radial dimension that is at least 50% of the second radial dimension.

5. The cell encapsulation device of claim 1 wherein the cover turns essentially translucent to transparent upon introduction of an aqueous solution into the device.

6. The cell encapsulation device of claim 1 wherein the cover comprises at least one layer of a thin tape of expanded polytetrafluoroethylene.

7. The cell encapsulation device of claim 1 further comprising cells contained in the device.

8. A method for loading cells into a cell encapsulation device, the method comprising:

providing a cell encapsulation device comprising a cell zone comprising a space delimited by a water wettable cover surrounding a cell displacing core within the cover;

wherein the cover has a coating thereon, the coating comprising a hydrophilic polymer material cross-linked to itself, wherein the cover is permeable to water and impermeable to cells such that the cover is a means to filter cells from solution upon introduction of cells and solution into the cell zone under a pressure less than about 6.9×

10⁵ Pa, thereby causing the solution to weep through the cover at a rate ranging from about 0.01 ml/cm² /minute to about 100 ml/cm² /minute while retaining the cells within the device;

wherein the core comprises a swellable material that expands from an initial first radial dimension to an enlarged second radial dimension upon exposure to an aqueous solution;

at least one opening within the cover;

means to seal the opening following introduction of cells into the device;

providing a cell delivery device to transfer an aqueous solution of cells into the device form a separate vessel containing cells;

transferring the cells from the separate vessel into the cell encapsulation device under pressure; and

allowing water to weep from the cover during the transferring of the cells, thereby concentrating the cells within the device.

9. The method of claim 8 that further comprises

swelling the core following transfer of the cells into the device.

10. The method of claim 8 that further comprises

providing a constrictive device at the opening to seal the opening of the device;

and

actuating the constrictive device to seal the opening following transfer of cells into the device.