Medical device for neural stimulation and controlled drug delivery

• US 7,599,737 B2
• Filed: 10/06/2003
• Issued: 10/06/2009
• Est. Priority Date: 10/04/2002
• Status: Expired due to Fees

• Current Assignee: DARE MB Incorporated
• Original Assignee: MicroCHIPS Inc.
• Inventors: Santini, John T. Jr., Herman, Stephen J., Yomtov, Barry M.
• Primary Examiner(s): Getzow; Scott M
• Application Number:
  US10/679,763
• Publication Number:
  US 20040127942A1
• Time in Patent Office: 2,192 Days
• Field of Search: 607/3, 607/41, 607/45, 607/48, 607/62, 607/52, 604 20- 21, 604 65- 67, 604/93.01, 604/890.1, 604/891.1, 604/892.1
• US Class Current: 607/3
• CPC Class Codes: A61K 9/0097 Micromachined devices; Microelectromechanical systems [MEMS]; Devices obtained by lithographic treatment of silicon; Devices comprising chips intradermal microneedle arrays A61K9/0021; MEMS in general B81B7/02
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Medical devices and methods are provided for electrical stimulation of neural tissue and controlled drug delivery to a patient. The device includes an implantable drug delivery module which comprises a plurality of reservoirs, a release system comprising at least one drug contained in each of the reservoirs, and control means for selectively releasing a pharmaceutically effective amount of drug from each reservoir; a neural electrical stimulator which comprises a signal generator connected to at least one stimulation electrode for operable engagement with a neural tissue of the patient; and at least one microcontroller for controlling operational interaction of the drug delivery module and the neural electrical stimulator. The microcontroller may control the signal generator and the control means of the drug delivery module. The device may further include a sensor operable to deliver a signal to the microcontroller, for example to indicate when to deliver electrical stimulation, drug, or both.

Claims

1. A medical device for electrical stimulation of neural tissue and controlled drug delivery comprising:

an implantable drug delivery module which comprises

a substrate having a plurality of reservoirs,

a release system contained in each of the reservoirs, wherein the release system comprises at least one drug,

a plurality of discrete reservoir caps, each being in register with an opening of one of the reservoirs, separating the release system from an environment outside of the reservoirs, and

means for disintegrating one or more of the reservoir caps by electrothermal ablation to release the at least one drug from one or more of the reservoirs;

a neural electrical stimulator which comprises

a signal generator, and

at least one stimulation electrode for operable engagement with a neural tissue of a patient, wherein the at least one stimulation electrode is connected to the signal generator; and

at least one microcontroller for controlling operational interaction of the drug delivery module and the neural electrical stimulator.

2. The medical device of claim 1, wherein the at least one microcontroller controls both the signal generator and the means for disintegrating one or more of the reservoir caps of the drug delivery module.

3. The medical device of claim 1, further comprising a power source operably connected to the means for disintegrating one or more of the reservoir caps, the neural electrical stimulator, the at least one microcontroller, or a combination thereof.

4. The medical device of claim 1, wherein the stimulation electrode is on an outer surface of a hermetically sealed encasement containing the drug delivery module and microcontroller.

5. The medical device of claim 1, further comprising a hermetically sealed encasement containing the drug delivery module and microcontroller, wherein the stimulation electrode extends a distance from the hermetically sealed encasement.

6. The medical device of claim 5, wherein a flexible catheter connects the stimulation electrode to the encasement.

7. The medical device of claim 1, further comprising telemetry components in operable communication with the microcontroller.

8. The medical device of claim 1, wherein the neural electrical stimulator is provided as a module separate from the drug delivery module.

9. The medical device of claim 8, wherein the neural electrical stimulator module is implantable.

10. The medical device of claim 8, wherein the drug delivery module is controlled by a telemetry or hard-wired signal from the stimulator module.

11. The medical device of claim 8, comprising two microcontrollers, one of which controls the stimulator module and the other which controls the drug delivery module.

12. The medical device of claim 1, adapted to treat chronic pain in a patient.

13. The medical device of claim 1, adapted to treat a movement disorder in a patient.

14. The medical device of claim 1, adapted to treat incontinence in a patient.

15. The medical device of claim 1, adapted to treat obesity in a patient.

16. The medical device of claim 1, adapted to control seizures in a patient.

17. The medical device of claim 1, wherein the drug delivery module comprises a microchip drug delivery device.

18. The medical device of claim 1, further comprising one or more sensors operable to deliver a signal to the microcontroller.

19. The medical device of claim 18, wherein the one or more sensors control release of the drug from the drug delivery module and control generation of an electrical current from the neural stimulator to neural tissue.

20. The medical device of claim 1, wherein the drug is an analgesic, an anti-anxiety agent, an anti-incontinence agent, a skeletal muscle relaxant, an anti-convulsant, or an anti-parkinson agent.

21. The medical device of claim 1, wherein the implantable drug delivery module comprises a catheter or tube, the plurality of reservoirs being located proximate to an end of the catheter or tube.

22. The medical device of claim 1, wherein the substrate comprises silicon and the discrete reservoir cap comprises at least one metal film.

23. The medical device of claim 22, wherein the discrete reservoir cap comprises a multi-layer structure comprising platinum and titanium.

24. A method of treating a patient comprising delivery of an electrical signal and at least one drug to a patient in need thereof comprising:

implanting into the patient a device comprising a drug delivery module which comprises a plurality of discrete reservoirs, each containing a drug, and a plurality of discrete reservoir caps, each in register with an opening of one of the reservoirs;

bringing an stimulator electrode into operable engagement with a neural tissue of the patient;

activating a signal generator to deliver electrical stimulation from the stimulator electrode to the neural tissue of the patient; and

passing an electric current though one or more of the discrete reservoir caps to disintegrate the one or more discrete reservoir caps by electrothermal ablation, thereby to release the drug from one or more of the reservoirs into the patient.

25. The method of claim 24, wherein the drug and the electrical neural stimulation are delivered simultaneously.

26. The method of claim 24, wherein the drug is delivered intermittently or continuously.

27. The method of claim 24, wherein the electrical stimulation is delivered intermittently or continuously.

28. The method of claim 24, wherein the drug is released before the electrical neural stimulation and is effective to reduce the stimulation threshold of the neural tissue.

29. The method of claim 24, wherein release of the drug is alternated with the delivery of the electrical stimulation.

30. The method of claim 24, wherein the neural electrical stimulator is provided as a module separate from the drug delivery module.

31. The method of claim 30, further comprising implanting the neural electrical stimulator into the patient.

32. The method of claim 24, which is used to treat chronic pain in the patient.

33. The method of claim 24, which is used to treat a movement disorder in the patient.

34. The method of claim 24, which is used to treat incontinence in the patient.

35. The method of claim 24, which is used to treat obesity in the patient.

36. The method of claim 24, which is used to control seizures in the patient.

37. The method of claim 24, wherein the device further comprises at least one microcontroller for controlling operational interaction of the drug delivery module and the neural electrical stimulator.