CHONDROCYTE CONTAINER AND METHOD OF USE

• US 20080299173A1
• Filed: 05/20/2008
• Published: 12/04/2008
• Est. Priority Date: 06/01/2007
• Status: Active Grant

• Current Assignee: Depuy Mitek LLC (Johnson & Johnson)
• Original Assignee: Johnson & Johnson Regenerative Therapeutics LLC (Johnson & Johnson)
• Inventors: Binette, Francois, Story, Brooks J., Brown, M. E. Liesbeth
• Granted Patent: US 8,257,963 B2
• Time in Patent Office: Days
• US Class Current: 424/424
• CPC Class Codes: A61K 35/32 Bones; Osteocytes; Osteoblasts; Tendons; Tenocytes; Teeth; Odontoblasts; Cartilage; Chondrocytes; Synovial membrane
• 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: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/3817 Cartilage-forming cells, e.g. pre-chondrocytes
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: 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
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 5/00 Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests vaccination appliances for veterinary use A61D1/025 ; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; containers specially adapted for medical or pharmaceutical purposes A61J1/00; combinations of vial and syringe for mixing or transferring their contents A61J1/20; holders for containers for collecting, storing or administering blood or medical fluids A61J1/16
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1452 pressurised by means of pistons
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: C12N 2533/76 Agarose, agar-agar
• CPC Class Codes: C12N 5/0655 Chondrocytes; Cartilage

Abstract

Devices and methods for delivering a therapeutic agent produced via a genetically-altered chondrocyte are provided. More specifically, the device includes a housing which defines a cell chamber configured to retain a large volume of chondrocytes while selectively releasing therapeutic agents produced via these entrapped cells. In an exemplary embodiment, the cell chamber can be configured such that a portion of cells can be positioned at least about 1.5 mm from an external wall of the device (i.e., about 1.5 mm away from an external nutrient supply). For example, the cell chamber can have a tubular configuration having a length and a diameter wherein each of these dimensions is at least about 3 mm (thereby the central core to the chamber is at least about 1.5 mm from the outer wall of the device).

Claims

1. A delivery device, comprising:

a housing having a cell chamber configured to retain a plurality of chondrocytes, the cell chamber having a length and a diameter, the length and the diameter each at least about 3 mm; and

a portion of the housing configured to allow passage of a therapeutic agent produced via the chondrocytes.

2. The delivery device of claim 1, wherein the housing comprises a rigid material.

3. The delivery device of claim 2, wherein the housing further includes at least one semi-permeable port configured to allow passage of the therapeutic agent.

4. The device of claim 1, further comprising a cap removably coupled to an end of the housing.

5. The delivery device of claim 1, further comprising a suture loop coupled to the housing, the suture loop configured to engage the device to a tissue.

6. The delivery device of claim 1, further comprising a radiopaque marker.

7. The delivery device of claim 1, wherein the housing further includes an expandable chamber, the expandable chamber separated from the cell chamber by a piston element.

8. The delivery device of claim 7, wherein the expandable chamber houses a water swellable agent configured to supply a force to the piston in response to an input of water.

9. The delivery device of claim 8, wherein the expandable chamber further includes a proximal end having an osmotic membrane thereby allowing for the input of water to the expandable chamber.

10. The delivery device of claim 7, further comprising an auxiliary fluid chamber positioned between the cell chamber and the expandable chamber, the auxiliary fluid chamber configured to house an auxiliary fluid and the auxiliary fluid chamber separated from the cell chamber via a semi-permeable membrane.

11. The delivery device of claim 10, wherein the auxiliary fluid includes cell nutrients.

12. The delivery device of claim 10, wherein the auxiliary fluid includes an agent capable of modifying an aspect of chondrocyte performance.

13. The delivery device of claim 1, further comprising a delivery tube in communication with the housing such that the therapeutic agent can be delivered from the cell chamber to a distant location.

14. The delivery device of claim 1, further comprising an auxiliary fluid reservoir in communication with the cell chamber via a valve, the valve configured to allow or prohibit the introduction of the auxiliary fluid to the cell chamber.

15. The delivery device of claim 14, further comprising a pump in communication with the fluid reservoir.

16. The delivery device of claim 1, further comprising a entrance port configured to allow for the introduction of chondrocytes to the cell chamber.

17. The delivery device of claim 16, wherein the entrance port is a rubber septum.

18. The delivery device of claim 1, wherein the housing is at least partially made from a porous material selected from the group consisting of metals, ceramics, and polymers.

19. A delivery device, comprising:

a cell chamber configured to retain a plurality of chondrocytes, the cell chamber further configured to allow for the release of a therapeutic agent produced by the chondrocytes, wherein the cell chamber is sized such that a portion of the chondrocytes are a distance of at least about 1.5 mm from an outer wall of the device.

20. A method for delivering a therapeutic agent to a surgical site, comprising:

disposing a plurality of chondrocytes into a cell chamber of a delivery device, the cell chamber sized such that a portion of the chondrocytes are a distance of at least about 1.5 mm from an outer wall of the device, the cell chamber configured to retain the condrocytes, and further configured to allow for release of a therapeutic agent produce by the condrocytes;

delivering the delivery device to a surgical site; and

delivering the therapeutic agent from the device to the surgical site.

21. The method of claim 20, further comprising:

suturing the delivery device at the treatment site.

22. The method claim 20 further comprising:

injecting additional chondrocytes into the delivery device.