Reservoir device for intraocular drug delivery

• US 7,883,717 B2
• Filed: 06/12/2002
• Issued: 02/08/2011
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Shelley, Terry Harrison, Barnes, Aaron Christopher, Varner, Signe Erickson, Dejuan, Eugene, Cooney, Michael J.
• Primary Examiner(s): Sheikh; Humera N
• Application Number:
  US10/171,406
• Publication Number:
  US 20030014036A1
• Time in Patent Office: 3,163 Days
• Field of Search: 424/422, 424/423, 424/427, 424/400
• US Class Current: 424/427
• 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 for delivering an agent to the interior of a patient'"'"'s eye, comprising:

an expandable reservoir having a proximal end and a distal end;

a hollow body at least partially housed within the reservoir, the hollow body having a proximal end and a distal end, wherein at least the proximal end of the hollow body extends out of the proximal end of the reservoir, and wherein the reservoir is fabricated of a pliable or elastomeric material that enables folding, rolling or compression of the reservoir about the hollow body, such that the cross section of the device with the reservoir folded, rolled, or compressed is about 1 mm or less;

an inlet port in the hollow body for injection of an agent into the hollow body;

one or more openings in the hollow body in communication with the reservoir for delivery of an agent from the hollow body to the reservoir; and

a delivery mechanism for delivering the agent from the reservoir to the interior of a patient'"'"'s eye at a desired rate.

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

3. The delivery device of claim 2, wherein the delivery mechanism comprises a single aperture at the distal end of the reservoir.

4. The delivery device of claim 2, wherein the size and/or number of the at least one aperture in the reservoir controls the rate of delivery of the agent.

5. The delivery device of claim 2, further comprising a mechanism for controlling the rate of delivery of the agent through the at least one aperture in the reservoir.

6. The delivery device of claim 5, wherein the mechanism for controlling the rate of delivery of therapeutic agent comprises a porous lining that covers the at least one aperture in the reservoir.

7. The delivery device of claim 5, wherein the mechanism for controlling the rate of delivery of therapeutic agent comprises a matrix material, a diffusion-limiting material or rate-limiting membrane covering the at least one aperture in the reservoir.

8. The delivery device 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.

9. The delivery device of claim 8, wherein the percentage of the reservoir fabricated of a material permeable to the agent controls the rate of delivery of the agent.

10. The delivery device of claim 1, wherein at least the distal end of the hollow body extends out of the reservoir and the delivery mechanism comprises the distal end of the hollow body.

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

12. The delivery device of claim 1, wherein the proximal end of the hollow body defines the inlet port.

13. The delivery device of claim 11, wherein the distal end of the hollow body extends outside the reservoir and comprises the delivery mechanism.

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

15. The device of claim 14, wherein pressure of the elastic material against the agent within the reservoir provides a driving force for delivery of agent through the delivery mechanism.

34. The delivery device of claim 1, wherein the device may be inserted through an incision requiring few or no sutures for closure.

35. The delivery device of claim 34, wherein the largest dimension of the cross section of the empty delivery device ranges from about 0.25 mm to about 1 mm.

36. The delivery device of claim 35, wherein the largest dimension of the cross section of the empty delivery device ranges from about 0.25 mm to about 0.5 mm.

37. The delivery device of claim 1, wherein the device has a length ranging from about 0.5 cm to about 1.5 cm.

38. The delivery device of claim 10, wherein the hollow body has a length ranging from about 1 cm to about 2.5 cm.

39. The delivery device of claim 10 wherein the hollow body has an outer diameter less than about 0.1 mm, and an inner diameter ranging from about 0.001 mm to about 0.007 mm.

40. The delivery device of claim 39, wherein the hollow body has an inner diameter ranging from about 0.005 mm to about 0.001 mm.

16. A sustained release delivery device for delivering an agent to a patient, comprising:

a hollow body having a proximal end and a distal end;

an inlet port at the proximal end of the hollow body for injection of the agent;

an expandable reservoir covering at least a portion of the hollow body, the reservoir fabricated of an elastomeric material that enables folding, rolling or compression of the reservoir about the hollow body such that the cross section of the device with the reservoir folded, rolled, or compressed is about 1 mm or less;

at least one aperture in the hollow body for providing communication between the hollow body and the reservoir;

a delivery mechanism for delivering the agent to the patient, the delivery mechanism in communication with the reservoir, whereby therapeutic agent injected through the inlet port travels into the reservoir and flows out of the reservoir through the delivery mechanism at a desired rate, and whereby the device utilizes the elastomeric properties of the reservoir housing the agent to deliver the agent from the reservoir to a treatment site at a desired rate.

17. The delivery device of claim 16, wherein the distal end of the hollow body extends outside the reservoir and comprises the delivery mechanism.

18. The delivery device of claim 16, further comprising a mechanism for controlling the rate of delivery of the agent through the delivery mechanism.

19. The delivery device of claim 18, wherein the mechanism for controlling the rate of delivery of the agent further comprises a porous lining that covers the delivery mechanism.

20. The delivery device of claim 18, wherein the mechanism for controlling the rate of delivery of the agent further comprises a matrix material, a diffusion-limiting material or rate-limiting membrane covering the delivery mechanism.

21. The delivery device of claim 18, wherein the delivery mechanism comprises the distal end of the hollow body and the mechanism for controlling the rate of delivery of the agent further comprises a plurality of apertures in the distal end of the hollow body.

22. The delivery device of claim 21, wherein the size and/or number of the plurality of apertures in the distal end of the hollow body controls the rate of delivery of the agent.

23. The delivery device of claim 16, wherein the delivery mechanism comprises at least a portion of the reservoir, which is fabricated of a material permeable to the agent.

24. The delivery device of claim 23, wherein the percentage of the reservoir fabricated of a material permeable to the agent further controls the rate of delivery of the agent.

25. The delivery device of claim 16, wherein the delivery mechanism comprises at least one aperture in the reservoir.

26. The delivery device of claim 25, wherein the delivery mechanism comprises a single aperture at the distal end of the reservoir.

27. The delivery device of claim 25, wherein the size and/or number of the at least one aperture in the reservoir further controls the rate of delivery of the agent.

28. The delivery device claim 16, wherein the delivery mechanism is a hollow tube extending from the distal end of the hollow body.

29. The delivery device of claim 16, further comprising a hub for securing the device at the treatment area.

30. The delivery device of claim 16, wherein the hollow body is rigid.

31. The delivery device of claim 16, wherein the hollow body is cylindrical in shape.

32. The delivery device of claim 16, wherein the inlet port is fabricated of an injectable self-sealing material.

33. The delivery device of claim 32, wherein the injectable self-sealing material is selected from silicone rubber, silicone elastomers and polyolefin.