Implantable refillable and ported controlled release drug delivery device

• US 6,852,106 B2
• Filed: 12/13/2001
• Issued: 02/08/2005
• Est. Priority Date: 12/14/2000
• Status: Expired due to Term

• Current Assignee: Control Delivery Systems Inc. (EyePoint Pharmaceuticals, Inc.)
• Original Assignee: Control Delivery Systems Inc. (EyePoint Pharmaceuticals, Inc.)
• Inventors: Shimizu, Robert W., LaPorte, Richard, Watson, David A.
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): Williams, Catherine S.
• Application Number:
  US10/013,946
• Publication Number:
  US 20020138068A1
• Time in Patent Office: 1,153 Days
• Field of Search: 604/288.01, 604/288.02, 604/288.03, 604/288.04, 604/890.1, 604/891.1
• US Class Current: 604/891.1
• CPC Class Codes: A61M 2039/0226 having means for protecting the interior of the access site from damage due to the insertion of a needle
• CPC Class Codes: A61M 2039/0229 having means for facilitating assembling, e.g. snap-fit housing or modular design
• CPC Class Codes: A61M 2210/0693 Brain, cerebrum
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: A61M 5/16877 Adjusting flow; Devices for setting a flow rate
• CPC Class Codes: A61M 5/427 Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Abstract

An implantable, refillable, rate controlled drug delivery device is disclosed that includes a base structure having at least a first opening and a second opening, the base structure defining a chamber, a septum covering the first opening and configured to substantially prevent leakage from the first opening to an exterior of the device, a drug delivery tube comprising a first and second distal end, wherein the first distal end of the tube communicates with the chamber through the second opening, and at least one rate-limiting permeable membrane disposed across a passage between the base structure and the second distal end of the drug delivery tube, which membrane passively regulates drug delivery. The drug delivery device is used to provide controlled drug delivery to an internal portion of the body and is advantageously leak-proof and does not rely on a pressure differential to drive the drug from the device.

Claims

1. An implantable, refillable, rate controlled drug delivery device, comprising:

a base structure having at least a first opening and a second opening, the base structure defining a chamber;

a septum covering the first opening and configured to substantially prevent leakage from the first opening to an exterior of the device;

a drug delivery tube comprising a proximal end and a distal end, wherein the proximal end of the tube communicates with the chamber through the second opening, and

at least one rate-limiting permeable membrane disposed at least partially within said chamber and across a passage between the base structure and said drug delivery tube proximal end, which membrane passively regulates drug delivery.

2. The implantable, refillable, rate controlled drug delivery device according to claim 1, wherein the device comprises two rate-limiting permeable membranes.

3. The implantable, refillable, rate controlled drug delivery device according to claim 1 wherein said at least one rate-limiting permeable membrane is disposed entirely within the chamber.

4. The implantable, refillable, rate controlled drug delivery device according to claim 3, wherein the septum comprises one of a polyvinyl alcohol, ethylene vinyl acetate, silicone, nylon, polypropylene, polycarbonate, cellulose, cellulose acetate, cellulose esters, polymer composites, Poly(2,6-Dimethylphenylene oxide), or polyether sulfone.

5. The implantable, refillable, rate controlled drug delivery device according to claim 1, wherein the chamber contains a drug to be delivered at a controlled rate to a target area of the body.

6. The implantable, refillable, rate controlled drug delivery device according to claim 5, wherein the target area of the body is the brain and the device is configured to deliver the drug thereto.

7. A method of controlling drug delivery to an internal portion of a body comprising administration of a drug to an internal portion of the body through a device according to claim 1 to control delivery of the drug.

8. The implantable, refillable, rate controlled drug delivery device according to claim 1, wherein the septum comprises one of a polyvinyl alcohol, ethylene vinyl acetate, silicone, nylon, polypropylene, polycarbonate, cellulose, cellulose acetate, cellulose esters, polymer composites, Poly(2,6-Dimethylphenylene oxide), or polyether sulfone.

9. The implantable, refillable, rate controlled drug delivery device according to claim 1, wherein the septum comprises at least one of a silicone elastomer, polyurethane elastomer, and polysulfide elastomer.

10. The implantable, refillable, rate controlled drug delivery device comprising:

a base structure having at least a first opening and a second opening, the base structure defining a chamber;

a septum covering the first opening and configured to substantially prevent leakage from the first opening to an exterior of the device;

a drug delivery tube comprising a proximal end and a distal end, wherein the proximal end of the tube communicates with the chamber through the second opening;

a rate-limiting permeable membrane disposed at least partially within said chamber and across a passage between the base structure and said drug delivery tube proximal end, which membrane passively regulates drug delivery;

a filter housing provided within the chamber adjacent the second opening; and

a filter element provided between the rate-limiting permeable membrane and the filter housing.

11. The implantable, refillable, rate controlled drug delivery device according to claim 10, wherein an upper portion of the filter housing comprises a needle stop.

12. The implantable, refillable, rate controlled drug delivery device according to claim 11, wherein the upper portion of the filter housing comprising a needle stop is disposed over the second opening.

13. The implantable, refillable, rate controlled drug delivery device according to claim 12, wherein the upper portion of the filter housing comprising a needle stop comprises a plurality of perforations.

14. The implantable, refillable, rate controlled drug delivery device according to claim 10, further comprising:

a retaining ring for compressively securing the septum in place.

15. The implantable, refillable, rate controlled drug delivery device according to claim 14, wherein the retaining ring and the base structure comprise a biologically compatible metal.

16. The implantable, refillable, rate controlled drug delivery device according to claim 15, wherein the biologically compatible metal comprises one of titanium or stainless steel.

17. The implantable, refillable, rate controlled drug delivery device according to claim 14, wherein the retaining ring and the base structure comprise a substantially rigid non-metallic biologically compatible material.

18. The implantable, refillable, rate controlled drug delivery device according to claim 17, wherein the biologically compatible material comprises one of a Polysulfone, an ultra-high molecular weight polyethylene, organometallic composites, phenolics, unsaturated polyesters, epoxy resins, polycarbonate, polyacetal, nylon, polyimide, and a pyrolytic carbon.

19. A method of controlling the delivery of a drug to an internal portion of a body comprising:

administering a drug to an internal portion of the body through a device according to claim 14 to control the delivery of the drug.

20. An implantable, refillable, rate controlled drug delivery device comprising:

a base structure having at least a first opening and a second opening, the base structure defining a chamber;

a septum covering the first opening and configured to substantially prevent leakage from the first opening to an exterior of the device;

a drug delivery tube comprising a proximal end and a distal end, wherein the proximal end of the tube communicates with the chamber through the second opening;

at least one rate-limiting permeable membrane disposed across a passage between the base structure and the distal end of the drug delivery tube, which membrane passively regulates drug delivery;

a filter housing provided within the chamber adjacent the second opening;

a filter element provided between the rate-limiting permeable membranes and the filter housing, and

a depressed region at least partially circumscribing the second opening,

wherein an upper portion of the filter housing comprises a needle stop,

wherein the upper portion of the filter housing comprising a needle stop is disposed over the second opening,

wherein the upper portion of the filter housing comprising a needle stop comprises a plurality of perforations, and

wherein the rate-limiting permeable membrane is positioned at least partially within the depressed region.