Reservoir device for intraocular drug delivery

• US 9,180,046 B2
• Filed: 07/15/2013
• Issued: 11/10/2015
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University, The Johns Hopkins University School of Medicine
• Original Assignee: Johns Hopkins University
• Inventors: Varner, Signe Erickson, De Juan, Eugene, Barnes, Aaron Christopher, Shelley, Terry Harrison, Cooney, Michael J.
• Primary Examiner(s): Wax, Robert A
• Assistant Examiner(s): Singh, Randeep
• Application Number:
  US13/942,610
• Publication Number:
  US 20130304031A1
• Time in Patent Office: 848 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 configured to be implanted into a vitreous chamber of an eye through a sutureless sclerotomy and formed a pliable wall configured to contain a therapeutic agent,

wherein one or more apertures formed in the pliable wall allow for sustained flow of the therapeutic agent contained in the refillable reservoir through the one or more apertures into the vitreous chamber at a rate of delivery, and

wherein the pliable wall has a first configuration having a first cross-sectional dimension suitable for insertion of the refillable reservoir through the sclerotomy into the vitreous chamber and a second configuration having a second, larger cross-sectional dimension, wherein therapeutic agent flows from the reservoir through the one or more apertures in the pliable wall when in the second configuration so as to deliver the therapeutic agent to the vitreous chamber over an extended period of time at the rate of delivery;

an inlet port positioned near a proximal end of the refillable reservoir having an injectable, self-sealing surface; and

an elongated, inner support around which at least a portion of the pliable wall is configured to adopt the first configuration, the inner support comprising a proximal end extending towards the inlet port and a distal end that is external to the pliable wall.

2. The device of claim 1, wherein the one or more apertures formed in the pliable wall are located along a length of the pliable wall of the reservoir.

3. The device of claim 1, wherein the one or more apertures formed in the pliable wall are located at a distal end of the pliable wall of the reservoir.

4. The device of claim 1, wherein a size, a number or a combination of the size and the number of the one or more apertures controls the rate of delivery of the therapeutic agent.

5. The device of claim 1, further comprising a mechanism for controlling the sustained flow of the therapeutic agent through the one or more apertures, wherein the mechanism comprises a porous lining that covers the one or more apertures, a matrix material, a diffusion-limiting material or rate-limiting membrane covering the one or more apertures.

6. The device of claim 1, wherein the pliable wall in the first configuration is folded, rolled or compressed into the first configuration.

7. The device of claim 1, wherein the first cross-sectional dimension is no greater than 0.5 mm in diameter.

8. The device of claim 1, wherein the pliable wall is fabricated of poly(ethylene terephthalate).

9. The device of claim 8, wherein the one or more apertures in the pliable wall are formed with a laser, hot wire, or drilling device.

10. The device of claim 1, wherein the inner support provides additional rigidity for insertion of the reservoir into the vitreous chamber.

11. The device of claim 1, wherein the proximal end of the inner support defines at least a portion of the inlet port.

12. The device of claim 1, further comprising an extension projecting outward from the inlet port, the extension having an upper surface surrounding the injectable, self-sealing surface and a lower surface configured to abut at least an external portion of the sclera surrounding the sclerotomy such that the device is stabilized by the extension.

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

(1) forming a sclerotomy through to a vitreous chamber of an eye, the sclerotomy having a size that requires no sutures for scleral closure;

(2) preparing an empty sustained release delivery device for implantation in the eye, the sustained release delivery device comprising;

(i) a refillable reservoir formed of a pliable wall configured to contain the therapeutic agent, wherein one or more apertures are formed in the pliable wall,

wherein the pliable wall has a first configuration having a first cross-sectional dimension suitable for insertion of the refillable reservoir through the sclerotomy into the vitreous chamber and a second configuration having a second, larger cross-sectional dimension, wherein therapeutic agent flows from the reservoir through the one or more apertures in the pliable wall when in the second configuration so as to deliver the therapeutic agent to the vitreous chamber over an extended period of time at the rate of delivery;

(ii) an inlet port positioned near a proximal end of the refillable reservoir having an injectable, self-sealing surface; and

(iii) an elongated, inner support around which at least a portion of the pliable wall is configured to adopt the first configuration, the inner support comprising a proximal end extending towards the inlet port and a distal end that is external to the pliable wall,

wherein preparing comprises compressing the pliable wall of the empty sustained release delivery device into the first configuration;

(3) inserting the compressed, empty reservoir through the sclerotomy into the vitreous chamber until the inlet port remains external to the vitreous chamber;

(4) injecting the therapeutic agent into the reservoir through the inlet port using an injection mechanism;

(5) expanding the compressed reservoir into the second configuration upon injecting the therapeutic agent; and

(6) flowing the therapeutic agent from the reservoir through the one or more apertures formed in the pliable wall into the vitreous chamber so as to deliver the therapeutic agent at a desired rate of delivery.

14. The method of claim 13, further comprising controlling the rate of delivery of the therapeutic agent by altering a size, a number or a combination of the size and the number of the one or more apertures.

15. The method of claim 13, further comprising controlling the rate of delivery of the therapeutic agent through the one or more apertures with a porous lining that covers the one or more apertures, a matrix material, a diffusion-limiting material or rate-limiting membrane covering the one or more apertures.

16. The method of claim 13, wherein compressing the pliable wall of the empty sustained release delivery device into the first configuration further comprises folding or rolling the pliable wall into the first configuration.

17. The method of claim 13, wherein the first cross-sectional dimension is no greater than 0.5 mm in diameter.

18. The method of claim 13, wherein the pliable wall is fabricated of poly(ethylene terephthalate).

19. The method of claim 18, wherein the one or more apertures are formed with a laser, hot wire, or drilling device.

20. The method of claim 13, further comprising filling the reservoir inserted within the vitreous chamber with an additional amount of the therapeutic agent using an injection mechanism inserted through the inlet port positioned external to the vitreous chamber.

21. The method of claim 13, further comprising compressing the reservoir back to the first configuration after the therapeutic agent is delivered and removing the device from the sclerotomy, wherein removing the device requires no sutures for scleral closure.