Reservoir device for intraocular drug delivery

• US 10,470,924 B2
• Filed: 10/11/2017
• Issued: 11/12/2019
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Johns Hopkins University
• Original Assignee: Johns Hopkins University
• Inventors: Erickson, Signe, de Juan, Jr., Eugene, Barnes, Aaron Christopher, Shelley, Terry Harrison, Cooney, Michael J.
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US15/730,537
• Publication Number:
  US 20180243131A1
• Time in Patent Office: 762 Days
• 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:

an elongate body having a proximal end and a distal end;

an elastomeric wall disposed around at least a portion of the elongate body forming a reservoir having a reservoir volume;

an inlet portion configured to be penetrated for injection of an amount of therapeutic agent into the reservoir after implantation in an eye; and

at least one outlet from the reservoir,

wherein the distal end of the elongate body is positioned away from the inlet and extends external to the reservoir,

wherein the elastomeric wall is configured to adopt a collapsed configuration having a first cross-sectional dimension and an expanded configuration having a second cross-sectional dimension larger than the first cross-sectional dimension after injection of the amount of therapeutic agent into the reservoir, and

wherein pressure of the elastomeric wall on the reservoir volume provides a driving force for delivery of the therapeutic agent from the reservoir through the at least one outlet into the vitreal cavity.

2. The device of claim 1, wherein the at least one outlet from the reservoir comprises a porous element at the distal end of the elongate body extending external to the reservoir such that the therapeutic agent is released from the reservoir through the porous element into the vitreal cavity.

3. The device of claim 2, wherein the porous element comprises a diffusion-limiting material covering an opening near the distal end of the body.

4. The device of claim 3, wherein a porosity of the diffusion-limiting material controls at least in part the rate of delivery of the therapeutic agent through the opening.

5. The device of claim 2, wherein delivery of therapeutic agent through the porous element is affected by intraocular pressure force.

6. The device of claim 1, wherein the at least one outlet from the reservoir comprises a material forming the elastomeric wall, wherein the material is permeable to the therapeutic agent.

7. The device of claim 6, wherein the material is selected from the group consisting of polycarbonates, polyolefins, polyurethanes, copolymers of acrylonitrile, copolymers of polyvinyl chloride, polyamides, polysuiphones, polystyrenes, polyvinyl fluorides, polyvinyl alcohols, polyvinyl esters, polyvinyl butyrate, polyvinyl acetate, polyvinylidene chlorides, polyvinylidene fluorides, polyimides, polyisoprene, polyisobutylene, polybutadiene, polyethylene, polyethers, polytetrafluoroethylene, polychloroethers, polymethylmethacrylate, polybutylmethacrylate, polyvinyl acetate, nylons, cellulose, gelatin, silicone rubbers and porous rubbers.

8. The device of claim 1, wherein the elongate body comprises one or more apertures providing fluid communication between the elongate body and the reservoir.

9. The device of claim 1, wherein the proximal end of the elongate body defines the inlet portion.

10. The device of claim 9, wherein the inlet portion is adapted to remain external to the sclera wall after insertion of the distal end of the elongate body into the vitreal cavity.

11. The device of claim 9, wherein the inlet portion configured to be penetrated further comprises a self-sealing material.

12. The device of claim 1, wherein the device is removable from the vitreal cavity of the eye.

13. The device of claim 1, wherein the proximal end of the elongate body further comprises a hub configured for securing the delivery device in the eye.

14. The device of claim 1, wherein the elongate body is formed of stainless steel, titanium, nitinol, or a polymer.

15. The device of claim 1, wherein the elongate body has a cross-sectional shape that is circular, square, rectangular, or octagonal.

16. The device of claim 1, wherein the first cross-sectional dimension is sized to be no greater than about 1 mm.

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