Reservoir device for intraocular drug delivery

• US 9,522,082 B2
• Filed: 03/03/2016
• Issued: 12/20/2016
• 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, de Juan, Eugene Jr., Barnes, Aaron Christopher, Shelley, Terry Harrison, Cooney, Michael J.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Singh, Randeep
• Application Number:
  US15/060,532
• Publication Number:
  US 20160184134A1
• Time in Patent Office: 292 Days
• Field of Search: None
• US Class Current: 1/1
• 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 sustained release delivery device, the delivery device comprising:

a refillable reservoir having a wall 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 forming a reservoir volume;

an inlet port in fluid communication with, and near a proximal end of, the reservoir, the inlet port configured for injection of an agent into the reservoir;

a hollow tube around which the reservoir adopts the collapsed configuration that provides sufficient rigidity for insertion of the reservoir through the scleral wall into the vitreal cavity of an eye, wherein the hollow tube comprises a proximal end and a distal end each extending external to the reservoir volume; and

a delivery mechanism for controlled, sustained diffusion of the agent to the vitreal cavity, the delivery mechanism in communication with the reservoir volume such that the agent is released from the reservoir volume through the delivery mechanism to the vitreal cavity at a desired rate.

2. The device of claim 1, wherein the delivery mechanism is positioned at a distal end of the hollow tube.

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

4. The device 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 device 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 device of claim 1, wherein the hollow tube comprises one or more apertures providing fluid communication between the hollow tube and the reservoir volume.

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

8. The device of claim 1, wherein the proximal end of the hollow tube structure defines the inlet port.

9. The device of claim 1, wherein the reservoir adopts the expanded configuration when filled with the agent.

10. The device of claim 1, wherein the reservoir wall is configured for folding, rolling or compression about the hollow tube.

11. The device of claim 1, wherein the inlet port is adapted to remain external to the sclera after insertion of the reservoir into the vitreal cavity.

12. The device of claim 1, wherein the reservoir wall is formed of a non-distensible material.

13. The device of claim 1, wherein the reservoir wall is formed of an elastomeric material having spring-like properties that at least partially drives delivery of the agent from the reservoir volume.

14. The device of claim 1, wherein the device when the reservoir is in the collapsed configuration has a largest cross-sectional dimension from about 0.25 mm to about 1 mm.

15. The device of claim 1, wherein the hollow body is rigid and cylindrical in shape.