Reservoir device for intraocular drug delivery

• US 8,486,052 B2
• Filed: 12/27/2010
• Issued: 07/16/2013
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Varner, Signe Erickson, Dejuan, Eugene, Barnes, Aaron Christopher, Shelley, Terry Harrison, Cooney, Michael J.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Singh, Randeep
• Application Number:
  US12/979,185
• Publication Number:
  US 20110098686A1
• Time in Patent Office: 932 Days
• Field of Search: None
• US Class Current: 604/890.1
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61M 2039/0205 for injecting media
• CPC Class Codes: A61M 2205/04 implanted
• CPC Class Codes: A61M 2210/0612 Eyes
• 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 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A delivery device that allows for the sustained release of an agent, particularly useful for the sustained release of a therapeutic agent to limited access regions, such as the posterior chamber of the eye and inner ear. The delivery device is minimally invasive, refillable and may be easily fixed to the treatment area. The delivery device includes a hollow body with an inlet port at its proximal end for insertion of the agent, a reservoir for holding the agent and a delivery mechanism for the sustained delivery of the agent from the reservoir to the patient.

Claims

1. A medical device kit, comprising a sustained release delivery device, the delivery device comprising:

a refillable reservoir sized and shaped for implantation into the vitreal cavity of an eye, the reservoir comprising a wall formed of a non-distensible material, the reservoir configured to adopt a collapsed configuration having a first cross-sectional dimension and an expanded configuration having a second, larger cross-sectional dimension after insertion into the eye;

an inlet port in fluid communication with, and at a proximal end of, the reservoir, the inlet port configured for injection of an agent into the reservoir after insertion of the reservoir into the eye, wherein the inlet port is adapted to remain external to the sclera after insertion of the reservoir into the vitreal cavity;

an inner support around which the reservoir is configured to adopt a collapsed configuration that provides sufficient rigidity for insertion of the device through the scleral wall and into the vitreal cavity, the inner support comprises a proximal end and a distal end each extending external to the reservoir; and

a delivery mechanism for controlled, sustained delivery of the agent to the patient, the delivery mechanism in communication with the reservoir such that the agent releases out of the reservoir through the delivery mechanism to a treatment site at a desired rate.

2. The kit of claim 1, wherein the delivery device is packaged in sterile condition.

3. The kit of claim 1, wherein the delivery mechanism comprises at least one aperture.

4. The kit of claim 3, wherein a size and/or a number of the at least one aperture controls the rate of delivery of the agent.

5. The kit of claim 3, further comprising a mechanism for controlling the rate of delivery of the agent through the at least one aperture, wherein the mechanism for controlling the rate of delivery of therapeutic agent comprises a porous lining that covers the at least one aperture, a matrix material, a diffusion-limiting material or rate-limiting membrane covering the at least one aperture.

6. The kit of claim 1, wherein the delivery mechanism comprises at least a portion of the reservoir, which is fabricated of a material permeable to the agent.

7. The kit of claim 1, wherein the delivery mechanism comprises the distal end of the inner support structure.

8. The kit of claim 1, further comprising a hub near the inlet port, the hub configured for securing the delivery device in place.

9. The kit of claim 1, wherein the proximal end of the inner support structure defines the inlet port.

10. The kit of claim 1, wherein the reservoir is fabricated of an elastic material whereby the reservoir expands when filled with the agent.

11. The kit of claim 1, wherein the reservoir is fabricated of a pliable or elastomeric material configured for folding, rolling or compression about the inner support structure.

12. A method for sustained delivery of a therapeutic agent, the method comprising:

providing a delivery device comprising;

(a) a refillable reservoir sized and shaped for implantation into the vitreal cavity of an eye, the reservoir comprising a wall formed of a non-distensible material, the reservoir configured to adopt a collapsed configuration having a first cross-sectional dimension and an expanded configuration having a second, larger cross-sectional dimension after insertion into the eye;

(b) an inlet port in fluid communication with, and at a proximal end of, the reservoir, the inlet port configured for injection of an agent into the reservoir after insertion of the reservoir into the eye, wherein the inlet port is adapted to remain external to the eye after insertion of the reservoir into the vitreal cavity;

(c) an inner support around which the reservoir is configured to adopt a collapsed configuration that provides sufficient rigidity for insertion of the device through the scleral wall and into the vitreal cavity, the inner support comprises a proximal end and a distal end each extending external to the reservoir; and

(d) a delivery mechanism for controlled, sustained delivery of the agent to the patient, the delivery mechanism in communication with the reservoir such that the agent releases out of the reservoir through the delivery mechanism to a treatment site at a desired rate;

inserting the refillable reservoir of the delivery device into the vitreal cavity of an eye through an incision while the inlet port remains external to the sclera after insertion of the reservoir into the vitreal cavity;

injecting the therapeutic agent into the device through the inlet port; and

flowing the therapeutic agent from the reservoir through the delivery mechanism so as to deliver the therapeutic agent to a treatment site at a desired rate.

13. The method of claim 12, wherein the flow of the therapeutic agent is induced utilizing elastomeric properties of the reservoir housing the agent to deliver the therapeutic agent from the reservoir to the treatment site at the desired rate.

14. The method of claim 12, wherein the flow is induced so as to effect treatment of an ocular condition in a patient by delivering one or more therapeutic agents to an eye of the patient.

15. The method of claim 12, wherein flowing the agent through the delivery mechanism at the desired rate comprises flowing the agent through at least one aperture.

16. The method of claim 15, wherein a size and/or a number of the at least one aperture controls the rate of delivery of the agent.

17. The method of claim 15, further comprising controlling the rate of delivery of the agent through the at least one aperture with a porous lining that covers the at least one aperture, a matrix material, a diffusion-limiting material or rate-limiting membrane covering the at least one aperture.

18. The method of claim 12, wherein the delivery mechanism comprises at least a portion of the reservoir, which is fabricated of a material permeable to the agent so that flowing the agent comprises flowing the agent through the material of the reservoir.

19. The method of claim 12, wherein the delivery mechanism comprises the distal end of the inner support structure.

20. The method of claim 12, wherein the device comprises a hub near the inlet port and further comprising securing the delivery device in an eye with the hub.

21. The method of claim 12, wherein the proximal end of the inner support structure defines the inlet port.

22. The method of claim 12, wherein the reservoir is fabricated of an elastic material whereby the reservoir expands when filled with the agent.

23. The method of claim 12, wherein the reservoir is fabricated of a pliable or elastomeric material and further comprising folding, rolling or compressing the reservoir about the inner support structure.