Reservoir device for intraocular drug delivery

• US 20030014036A1
• Filed: 06/12/2002
• Published: 01/16/2003
• 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.
• Granted Patent: US 7,883,717 B2
• Time in Patent Office: Days
• US Class Current: 604/521
• 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:

a reservoir having a proximal end and a distal end;

an inlet port near the proximal end of the reservoir for injection of an agent into 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 or 3, 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 the delivery mechanism comprises a hollow tube extending from the distal end of the reservoir.

11. The delivery device of any one of claims 1 through 10, further comprising a hub near the inlet port for securing the delivery device in place.

12. The delivery device of any one of claims 1 through 11, further comprising a hollow body at least partially housed in the reservoir.

13. The delivery device of claim 1, wherein the hollow body has a proximal end and a distal end, and the proximal end of the hollow body extends outside the reservoir and comprises the inlet port.

14. The delivery device of claim 12 or 13, wherein the distal end of the hollow body extends outside the reservoir and comprises the delivery mechanism.

15. The delivery device of claim 14 further comprising at least one aperture in a portion of the hollow body housed in the reservoir, whereby the at least one aperture provides communication between the contents of the hollow body and the contents of the reservoir.

16. The device of any one of claims 1 through 15, wherein the reservoir is fabricated of a pliable material that enables folding, rolling and/or compression of the reservoir

17. The device of claim 16, wherein the reservoir is fabricated of an elastic material whereby the reservoir expands when filled with the agent.

18. The device of claim 17, wherein pressure of the elastic material against the agent within the reservoir provides a driving force for delivery of agent through the delivery mechanism.

21. The delivery device of claim 19 or 20, further comprising a mechanism for controlling the rate of delivery of the agent through the delivery mechanism.

22. The delivery device of claim 21, wherein the mechanism for controlling the rate of delivery of the agent comprises a porous lining that covers the delivery mechanism.

23. The delivery device of claim 21, wherein the mechanism for controlling the rate of delivery of the agent comprises a matrix material, a diffusion-limiting material or rate-limiting membrane covering the delivery mechanism.

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

25. The delivery device of claims 24, 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.

26. The delivery device of claim 19, wherein the delivery mechanism comprises at least a portion of the reservoir, which is fabricated of a material permeable to the agent.

27. The delivery device of claim 26, wherein the percentage of the reservoir fabricated of a material permeable to the agent controls the rate of delivery of the agent.

28. The delivery device of claim 19, wherein the delivery mechanism comprises at least one aperture in the reservoir.

29. The delivery device of claim 28, wherein the delivery mechanism comprises a single aperture at the distal end of the reservoir.

30. The delivery device of claim 28, wherein the size and/or number of the at least one aperture in the reservoir controls the rate of delivery of the agent.

31. The delivery device claim 19, wherein the delivery mechanism is a hollow tube extending from the distal end of the hollow body.

37. The delivery device of any one of claims 1 through 36, wherein the device may be inserted through an incision requiring few or no sutures for closure.

40. The delivery device of any one of claims 1 through 39, wherein the device has a length ranging from about 0.5 cm to about 1.5 cm.

41. The delivery device of claim 10 or 31, wherein the hollow tube has a length ranging from about 1 cm to about 2.5 cm.

42. The delivery device of any one of claims 10, 31 or 41 wherein the hollow tube 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.

43. The delivery device of claim 42, wherein the hollow tube has an inner diameter ranging from about 0.005 mm to about 0.001 mm.

46. A medical device kit, comprising one or more of the delivery devices of any one of claims 1 through 45.

50. A method for sustained delivery of an agent comprising using the sustained release delivery device of any one of claims 1 through 45 by inserting the device into the treatment area through an incision, injecting therapeutic agent into the device through the inlet port to fill the reservoir, and allowing the delivery mechanism to deliver the agent to a treatment site at a desired rate.

52. A method for the treatment of ocular conditions in patients comprising utilizing the delivery device of any one of claims 1 through 45 to deliver one or more therapeutic agents to the eye of the patient.

19. 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;

a pliable reservoir covering at least a portion of the hollow body;

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 is injected through the inlet port and travels into the reservoir and, whereby upon closure of the inlet port, the therapeutic agent flows out of the reservoir through the delivery mechanism at a desired rate.

32. The delivery device of any one of claims 19 through 31, further comprising a hub for securing the device at the treatment area.

33. The delivery device of any one of claims 19 through 32, wherein the hollow body is rigid.

34. The delivery device of any one of claims 19 through 33, wherein the hollow body is cylindrical in shape.

35. The delivery device of any one of claims 19 through 33, wherein the inlet port is fabricated of an injectable self-sealing material.

36. The delivery device of claim 35, wherein the injectable self-sealing material is selected from silicone rubber, silicone elastomers and polyolefin.

38. The delivery device of claim 37, wherein the largest dimension of the cross section of the empty delivery ranges from about 0.25 mm to about 1 mm.

39. The delivery device of claim 38, wherein the largest dimension of the cross section of the empty delivery ranges from about 0.25 mm to about 0.5 mm.

20. The delivery device of 19, wherein the distal end of the hollow body extends outside the reservoir and comprises the delivery mechanism.

44. A sustained release delivery device that utilizes the elastomeric properties of a reservoir housing an agent to deliver the agent from the reservoir to a treatment site at a desired rate.

47. The kit of claim 46, wherein the one or more delivery devices are packaged in sterile condition.

45. A sustained release delivery device comprising

a reservoir fabricated of an elastomeric material, the reservoir having a proximal end and a distal end;

an inlet port near the proximal end of the reservoir for injection of an agent into 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, whereby the delivery device utilizes the elastomeric properties of the reservoir to deliver the agent at a desired rate.

48. A method for sustained delivery of an agent, the method comprising the steps of:

(a) providing a sustained release delivery device comprising;

a pliable reservoir having a proximal end and a distal end, the reservoir being empty;

an inlet port near the proximal end of the reservoir for injection of an agent into the reservoir; and

a delivery mechanism for delivering the agent from the reservoir to the patient;

(b) making an incision in the patient to access the treatment area;

(c) compressing the pliable reservoir for insertion;

(d) inserting the delivery device into the treatment area through the incision such that the inlet port remains outside the incision;

(e) using an injection mechanism to inject the agent through the inlet port;

(f) allowing the therapeutic agent to flow into the reservoir;

(g) removing the injection mechanism from the inlet port and closing off the inlet port;

(h) allowing the therapeutic agent to travel out of the reservoir and to the patient through the delivery mechanism;

(i) optionally repeating steps (c) through (h) one or more times; and

(j) removing the delivery device from the treatment area.

49. A method for sustained delivery of an agent, the method comprising the steps of:

(a) providing a sustained release delivery device 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;

a pliable reservoir covering at least a portion of the hollow body, the reservoir being empty;

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 in the reservoir to the patient;

(b) making an incision in the patient to access the treatment area;

(c) compressing the pliable reservoir about the hollow body for insertion;

(d) inserting the delivery device into the treatment area through the incision such that the inlet port remains outside the incision;

(e) using an injection mechanism to inject the therapeutic agent through the inlet port;

(f) allowing the therapeutic agent to flow through the hollow body, through the at least one aperture in the hollow body and into the reservoir;

(g) removing the injection mechanism from the inlet port and closing off the inlet port;

(h) allowing the therapeutic agent to travel out of the reservoir and to the patient through the a delivery mechanism;

(i) optionally repeating steps (c) through (h) one or more times; and

(j) removing the delivery device from the treatment area.

51. A method for sustained delivery of an agent comprising utilizing the elastomeric properties of a reservoir housing the agent to deliver the agent from the reservoir to a treatment site at a desired rate.