Drug-delivery pumps and methods of manufacture

• US 9,861,525 B2
• Filed: 07/17/2015
• Issued: 01/09/2018
• 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 S., Tai, Yu-Chong
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US14/802,503
• Publication Number:
  US 20160015564A1
• Time in Patent Office: 907 Days
• Field of Search: 604 8- 9
• 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 method of manufacturing an implantable pump, including providing an upper layer comprising a dome structure for housing a drug chamber and a cannula in fluid communication with the drug chamber, providing a middle deflection layer adjacent the drug chamber, providing a bottom layer comprising electrolysis electrodes, and bonding the upper layer, middle deflection layer, and bottom layer to form the pump.

Claims

1. An implantable ophthalmic pump comprising:

a drug pump;

a glaucoma drainage device;

a first group of one or more cannulas configured for fluidly coupling the drug pump to a first treatment site in a patient; and

a second group of one or more cannulas configured for fluidly coupling the glaucoma drainage device to a second treatment site in the patient,

wherein the glaucoma drainage device comprises a portion of a surface area above the drug pump.

2. The implantable ophthalmic pump of claim 1, wherein the drug pump further comprises a drug reservoir fluidly coupled to the first treatment site via the first group of one or more cannulas.

3. The implantable ophthalmic pump of claim 1, wherein the first group of one or more cannulas comprises a check valve that only allows liquid flowing from a drug chamber of the drug pump into the first treatment site within an eye.

4. The implantable ophthalmic pump of claim 1, wherein at least one of the first or second treatment sites is located within a posterior chamber of an eye.

5. The implantable ophthalmic pump of claim 1, wherein at least one of the first or second treatment sites is located within an anterior chamber of an eye.

6. The implantable ophthalmic pump of claim 1, wherein the second group of one or more cannulas comprises a check valve that only allows aqueous humor to flow from the second treatment site within an eye to the glaucoma drainage device.

7. The implantable ophthalmic pump of claim 6, wherein the check valve opens when an intraocular pressure rises above a threshold pressure.

8. The implantable ophthalmic pump of claim 1, wherein the glaucoma drainage device comprises at least one fluid channel for conducting aqueous fluid to a region below a conjunctiva of an eye.

9. An implantable ophthalmic pump comprising:

a drug pump;

a glaucoma drainage device;

a first group of one or more cannulas configured for fluidly coupling the drug pump to a first treatment site in a patient; and

a second group of one or more cannulas configured for fluidly coupling the glaucoma drainage device to a second treatment site in the patient,

wherein the glaucoma drainage device comprises an end plate disposed over a shell of the implantable ophthalmic pump.

10. The implantable ophthalmic pump of claim 9, wherein the first group of one or more cannulas comprises a check valve that only allows liquid flowing from a drug chamber of the drug pump into the first treatment site within an eye.

11. The implantable ophthalmic pump of claim 9, wherein the second group of one or more cannulas comprises a check valve that only allows aqueous humor to flow from the second treatment site within an eye to the glaucoma drainage device.

12. The implantable ophthalmic pump of claim 11, wherein the check valve opens when an intraocular pressure rises above a threshold pressure.

13. An implantable ophthalmic pump comprising:

a drug pump;

a glaucoma drainage device;

a first group of one or more cannulas configured for fluidly coupling the drug pump to a first treatment site in a patient; and

a second group of one or more cannulas configured for fluidly coupling the glaucoma drainage device to a second treatment site in the patient,

wherein the glaucoma drainage device comprises an end plate integrated into a shell of the implantable ophthalmic pump.

14. The implantable ophthalmic pump of claim 13, wherein the first group of one or more cannulas comprises a check valve that only allows liquid flowing from a drug chamber of the drug pump into the first treatment site within an eye.

15. The implantable ophthalmic pump of claim 13, wherein the second group of one or more cannulas comprises a check valve that only allows aqueous humor to flow from the second treatment site within an eye to the glaucoma drainage device.

16. The implantable ophthalmic pump of claim 15, wherein the check valve opens when an intraocular pressure rises above a threshold pressure.

17. An implantable ophthalmic pump comprising:

a drug pump;

a glaucoma drainage device;

a first group of one or more cannulas configured for fluidly coupling the drug pump to a first treatment site in a patient;

a second group of one or more cannulas configured for fluidly coupling the glaucoma drainage device to a second treatment site in the patient; and

a single cannula sleeve surrounding the first and second groups of one or more cannulas.

18. The implantable ophthalmic pump of claim 17, wherein the first group of one or more cannulas comprises a check valve that only allows liquid flowing from a drug chamber of the drug pump into the first treatment site within an eye.

19. The implantable ophthalmic pump of claim 17, wherein the second group of one or more cannulas comprises a check valve that only allows aqueous humor to flow from the second treatment site within an eye to the glaucoma drainage device.

20. The implantable ophthalmic pump of claim 19, wherein the check valve opens when an intraocular pressure rises above a threshold pressure.

21. A method of simultaneously administering a drug and dissipating aqueous fluid, the method comprising the steps of:

providing a pump comprising an electrolysis chamber and a drug chamber;

providing a glaucoma drainage device comprising a portion of a surface area above the pump;

activating the electrolysis chamber to dispense a volume of drug from the drug chamber to a treatment site, the drug chamber decreasing in volume as the drug is dispensed therefrom;

deactivating the electrolysis chamber to stop dispensing the drug, whereby the electrolysis chamber decreases in volume; and

providing a fluidic pathway to conduct a portion of the dispensed drug and aqueous fluid from the treatment site to the glaucoma drainage device when an intraocular pressure exceeds a predetermined limit.

22. The method of claim 21, wherein the pump further comprises a check valve to prevent fluid flow through the fluidic pathway to the drainage device when the intraocular pressure is below the predetermined limit.

23. The method of claim 22, wherein the check valve opens when the intraocular pressure exceeds the predetermined limit.

24. The method of claim 21, wherein the predetermined limit is 12 mmHg.

25. The method of claim 21, wherein the predetermined limit is 17 mmHg.

26. The method of claim 21, further comprising dispensing the drug from the drug chamber through a plurality of cannulas in fluid communication therewith.

27. The method of claim 26, wherein each cannula comprises at least one of a check valve or a sensor.

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

29. The method of claim 21, further comprising monitoring the dissipation of the aqueous fluid using at least one flow sensor.