DRUG-DELIVERY PUMPS AND METHODS OF MANUFACTURE

• US 20090306594A1
• Filed: 05/08/2009
• Published: 12/10/2009
• Est. Priority Date: 05/08/2008
• Status: Active Grant

• Current Assignee: MiniPumps, LLC
• Original Assignee: MiniPumps, LLC
• Inventors: Tai, Yu-Chong, Shih, Jason, Humayun, Mark, Caffey, Sean, Pang, Changlin, Brennan, Jeffrey, Jiang, Fukang, Peck, Raymond
• Granted Patent: US 9,162,024 B2
• Time in Patent Office: Days
• US Class Current: 604/133
• 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 drug reservoir, a cannula fluidly coupled to the reservoir, a pumping mechanism for forcing liquid from the reservoir through the cannula, control circuitry for operating the pumping mechanism, and a power source comprising primary and auxiliary batteries in a stacked configuration, only the main battery being operatively coupled to the control circuitry during normal operation, the control circuitry operatively coupling the back-up battery upon detection of an electrical fault. The pump may further include a hermetic enclosure containing the control circuitry and the power source.

Claims

1. An implantable pump comprising:

a drug reservoir;

a cannula fluidly coupled to the reservoir;

a pumping mechanism for forcing liquid from the reservoir through the cannula;

control circuitry for operating the pumping mechanism;

a power source comprising primary and auxiliary batteries in a stacked configuration, only the main battery being operatively coupled to the control circuitry during normal operation, the control circuitry operatively coupling the back-up battery upon detection of an electrical fault; and

a hermetic enclosure containing the control circuitry and the power source.

2. The pump of claim 1, wherein following operative coupling of the back-up battery the control circuitry continues to operate the pumping mechanism.

3. The pump of claim 1, wherein following operative coupling of the back-up battery the control circuitry executes a shutdown of the pump.

4. The pump of claim 1, wherein following operative coupling of the back-up battery, the control circuitry causes an alert to be issued.

5. The pump of claim 2, wherein the alert comprises at least one of a vibration, an audible signal, a shock, transcutaneous neural stimulation, or an optical signal.

6. The pump of claim 1, wherein the hermetic enclosure comprises a substantially opaque enclosure having a transparent window.

7. An implantable pump comprising:

a drug reservoir;

a cannula fluidly coupled to the reservoir;

a pumping mechanism for forcing liquid from the reservoir through the cannula;

control circuitry for operating the pumping mechanism;

a power source comprising a battery; and

a hermetic enclosure containing the control circuitry and the power source, wherein a surface of the enclosure is shaped to conform to a curved anatomical region, the battery being shaped to conform to the enclosure surface.

8. The pump of claim 7, wherein the battery comprises at least one of a LiPON battery or a lithium polymer battery.

9. The pump of claim 7, wherein the hermetic enclosure comprises titanium, nitinol, niobium, polypropylene, polyimide, polyetheretherketone (PEEK), glass, ceramic, or epoxy.

10. The pump of claim 7, wherein the hermetic enclosure comprises at least one suture anchoring element.

11. The pump of claim 7, wherein the pump comprises at least one wireless telemetry coil operably connected to the control circuitry.

12. The pump of claim 7, wherein a surface of the enclosure is shaped to conform to a portion of an eye, brain, spine or knee.

13. The pump of claim 12, wherein the surface of the enclosure is shaped with a concave indentation into the case, so as to accommodate a spherical tissue.

14. The pump of claim 7, wherein the hermetic enclosure comprises a substantially opaque enclosure having a transparent window.

15. An implantable pump comprising:

a drug reservoir;

a cannula fluidly coupled to the reservoir;

a pumping mechanism for forcing liquid from the reservoir through the cannula;

control circuitry for operating the pumping mechanism;

a wireless communication module, operatively coupled to the control circuitry, for communicating with an external source; and

a hermetic enclosure containing the control circuitry and the communication module.

16. The pump of claim 15, further comprising a pump power source, the communication module being configured to inductively receive power from the external source and to thereby charge the pump power source.

17. The pump of claim 16, wherein the pump power source comprises at least one battery.

18. The pump of claim 15, further comprising a memory, operatively coupled to the control circuitry, for storing a program, wherein (i) the control circuitry operates the pumping mechanism in accordance with the program, and (ii) the program is changeable in accordance with signals received from the external source via the communication module.

19. The pump of claim 15, wherein the communication module communicates inductively with the external source.

20. The pump of claim 15, wherein the communication module communicates with the external source via far-field coupling.

21. The pump of claim 15, wherein the communication module communicates optically with the external source.

22. The pump of claim 15, wherein the communication module communicates unidirectionally with the external source.

23. The pump of claim 15, wherein the communication module communicates bidirectionally with the external source.

24. The pump of claim 15, wherein the communication module communicates a failure condition, detected by the control circuitry, to the external source.

25. The pump of claim 15, wherein the hermetic enclosure comprises a substantially opaque enclosure having a transparent window.

26. A communication device for communicating inductively with an implanted drug pump, the communication device comprising:

a transmission circuit;

an antenna or coil; and

a wearable support for the antenna or coil, the support, when worn, bringing the antenna or coil into proximity to the implanted drug pump.

27. The communication device of claim 26, wherein the support is in the form of eyeglasses, an eye patch, a headband, a belt a knee brace, or an audiovisual device.

28. The communication device of claim 26, wherein the transmission circuit is deployed in a housing connected to the support via a cable.

29. The communication device of claim 26, wherein the transmission circuit is deployed in a housing wirelessly connected to the support.

30. The communication device of claim 26, wherein the transmission circuit transmits data to the implanted drug pump.

31. The communication device of claim 26, wherein the transmission circuit also receives data from the implanted drug pump.

32. The communication device of claim 26, wherein the transmission circuit transmits power to the implanted drug pump.

33. An implantable pump comprising:

a drug reservoir comprising at least one expandable diaphragm;

a cannula fluidly coupled to the reservoir;

a pumping mechanism for forcing liquid from the reservoir through the cannula, the pumping mechanism comprising means for expanding the expandable diaphragm so that fluid is forced from the drug reservoir into the cannula;

control circuitry for operating the pumping mechanism;

a power source for powering the control circuitry; and

a hermetic enclosure containing the control circuitry, and the power source.

34. The pump of claim 33, wherein at least one of the drug reservoir, the cannula, the pumping mechanism, or the hermetic enclosure comprises or consists essentially of a biocompatible material.

35. The pump of claim 34, wherein the biocompatible material comprises or consists essentially of parylene.

36. The pump of claim 33, wherein activation of the electrolysis electrodes causes generation of a gas to expand the expandable diaphragm.

37. The pump of claim 33, further comprising a permeable material located above the drug reservoir.

38. The pump of claim 37, wherein the permeable material comprises at least one of an osmotic diaphragm or a perforated shell.

39. The pump of claim 37, wherein the permeable material is adapted to allow a body fluid to flow into a chamber located above the drug reservoir at a sufficient rate to substantially offset a vacuum pressure applied to the drug reservoir.