Drug-delivery pumps and methods of manufacture

• US 8,529,538 B2
• Filed: 07/03/2012
• Issued: 09/10/2013
• Est. Priority Date: 05/08/2008
• Status: Active Grant

• Current Assignee: MiniPumps, LLC
• Original Assignee: MiniPumps, LLC
• Inventors: Pang, Changlin, Jiang, Fukang, Shih, Jason, Caffey, Sean, Humayun, Mark, Tai, Yu-Chong
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US13/541,005
• Publication Number:
  US 20120277733A1
• Time in Patent Office: 434 Days
• Field of Search: 604/500, 604/891.1, 604/890.1, 604/892.1, 604/506
• US Class Current: 604/500
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 2005/14204 with gas-producing electrochemical cell
• CPC Class Codes: A61M 2005/14264 with means for compensating influence from the environment
• CPC Class Codes: A61M 2205/0244 Micromachined materials, e.g. made from silicon wafers, microelectromechanical systems [MEMS] or comprising nanotechnology
• CPC Class Codes: A61M 2210/0612 Eyes
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 5/1408 in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/14593 the diaphragm being actuated by fluid pressure
• CPC Class Codes: A61M 5/16886 for measuring fluid flow rate, i.e. flowmeters
• CPC Class Codes: B44C 1/227 by etching
• CPC Class Codes: Y10T 156/1092 All laminae planar and face to face
• CPC Class Codes: Y10T 156/1093 with covering of discrete laminae with additional lamina

Abstract

Embodiments of an implantable electrolytic pump include a first expandable diaphragm and a second flexible diaphragm, and first and second chambers each for containing a fluid, wherein the first expandable diaphragm separates the first and second chambers and provides a fluid barrier therebetween, and the second chamber is formed between the first expandable diaphragm and the second flexible diaphragms. The pump may further include electrolysis electrodes within the first chamber for causing generation of a gas therein and to thereby expand the expandable diaphragm so that fluid is forced from the second chamber into a cannula.

Claims

1. A method of administering a drug, the method comprising the steps of:

providing a pump comprising an electrolysis chamber, a drug chamber and a perforated shell thereover, the shell being in contact with a surrounding fluid;

activating the electrolysis chamber to dispense a volume of drug from the drug chamber, whereby the drug chamber decreases in volume as drug is dispensed therefrom; and

deactivating the electrolysis chamber to stop dispensation of the drug whereby the electrolysis chamber decreases in volume, the decrease in volume of the electrolysis chamber causing a buildup of vacuum pressure on the drug chamber via a common membrane, fluid being admitted through the shell perforations to offset the decreased volume of the drug chamber and prevent the buildup of vacuum pressure thereon.

2. The method of claim 1, wherein the activating step comprises activating electrolysis electrodes within the electrolysis chamber for causing generation of a gas therein.

3. The method of claim 2, wherein the electrolysis chamber contains at least one liquid electrolyte which causes electrolysis of the gas.

4. The method of claim 3, wherein the gas returns to a substantially liquid state upon deactivation of the electrolysis electrodes.

5. The method of claim 1, wherein the electrolysis chamber comprises a recombination catalyst.

6. The method of claim 5, wherein the recombination catalyst comprises platinum.

7. The method of claim 1, wherein the fluid comprises a saline solution, a solution comprising magnesium sulfate, a solution comprising sodium sulfate, or pure water.

8. The method of claim 1, wherein the generation of a gas within the electrolysis chamber expands a first expandable diaphragm located between the electrolysis chamber and the drug chamber.

9. The method of claim 8, wherein the pump further comprises a second flexible diaphragm located between the drug chamber and the perforated shell.

10. The method of claim 9, wherein at least one of the first diaphragm and second diaphragm comprises or consists essentially of parylene or a composite material.

11. The method of claim 10, wherein the composite material comprises platinum and parylene.

12. The method of claim 1, wherein the perforated shell is substantially rigid.

13. The method of claim 1, wherein the perforated shell comprises at least one of a biocompatible plastic material or a metal.

14. The method of claim 13, wherein the perforations are sized and shaped to allow a body fluid to flow therethrough at a sufficient rate to substantially offset a vacuum pressure applied to the drug chamber.

15. The method of claim 1, wherein the pump further comprises an osmotic diaphragm between the drug chamber and the perforated shell to form an osmosis chamber between the drug chamber and the osmotic diaphragm, the osmotic diaphragm allowing a body fluid to flow therethrough into the osmosis chamber.

16. The method of claim 15, wherein the osmotic diaphragm is adapted to allow a body fluid to flow into the osmosis chamber at a sufficient rate to substantially offset the decreased volume of the drug chamber.

17. The method of claim 1, wherein the drug is dispensed through at least one cannula in fluid communication with the drug chamber.

18. The method of claim 1, further comprising dispensing the drug through a plurality of cannulas in fluid communication with the drug chamber.

19. The method of claim 18, wherein each cannula comprises at least one of a check valve or a sensor.

20. The method of claim 1, further comprising controlling the dispensing of the drug using at least one check valve.

21. The method of claim 1, further comprising monitoring the dispensing of the drug using at least one flow sensor.