Satellite therapy delivery system for brain neuromodulation

• US 8,442,644 B2
• Filed: 11/16/2009
• Issued: 05/14/2013
• Est. Priority Date: 11/18/2008
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Stevenson, Robert A., Frysz, Christine A., Muffoletto, Barry C., Siegler, Robert W., Winn, Steven W., Skwara, Thomas A., Frustaci, Dominick J.
• Primary Examiner(s): MALAMUD, DEBORAH LESLIE
• Application Number:
  US12/619,551
• Publication Number:
  US 20100125312A1
• Time in Patent Office: 1,275 Days
• Field of Search: 607 1- 2, 607/45, 607/60, 607115-116, 607/118, 607/139
• US Class Current: 607/60
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37282 characterised by communication with experts in remote locations using a network
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

Deep brain electrodes are remotely sensed and activated by means of a remote active implantable medical device (AIMD). In a preferred form, a pulse generator is implanted in the pectoral region and includes a hermetic seal through which protrudes a conductive leadwire which provides an external antenna for transmission and reception of radio frequency (RF) pulses. One or more deep brain electrode modules are constructed and placed which can transmit and receive RF energy from the pulse generator. An RF telemetry link is established between the implanted pulse generator and the deep brain electrode assemblies. The satellite modules are configured for generating pacing pulses for a variety of disease conditions, including epileptic seizures, Turrets Syndrome, Parkinson'"'"'s Tremor, and a variety of other neurological or brain disorders.

Claims

1. A satellite therapy delivery system for brain neuromodulation, comprising:

a) a satellite brain stimulation and/or sensing (SBS) module comprising;

i) at least one biologic stimulating and/or sensing electrode;

ii) a biocompatible and hermetically sealed SBS housing;

iii) a first electrical power source disposed within the SBS housing, and a first RF transceiver for RF wireless communication with a control module; and

iv) a processing circuit electrically connected to the first RF transceiver, and the first electrical power source;

b) the control module, capable of analyzing an SBS RF wireless signal module, comprising a second RF transceiver and a microprocessor, the second RF transceiver and the microprocessor being electrically connectable to a second electrical power source positioned within the SBS housing;

c) the SBS housing is positionable within a burr hole through a patient'"'"'s skull; and

d) wherein the biologic stimulating and/or sensing electrode is actuatable by the SBS processing circuit in response to an RF wireless signal having been received from the control module, the control module RF wireless signal having been firstly received by the SBS module and secondly analyzed by the control module.

2. The system of claim 1, wherein the control module is not implanted within a skull, of a patient.

3. The system of claim 1, wherein the control module is configured to be externally worn by a patient having an implanted module.

4. The system of claim 1, wherein the stimulating and/or sensing electrode of the SBS module are selected from the group consisting of a deep brain electrode, and a subcutaneous or subdural paddle, patch or pad electrode.

5. The system of claim 1, wherein the control module and the SBS module are configured to operate in an open loop communication mode.

6. The system of claim 1, wherein the control module and the SBS module are configured to operate in a closed loop communication mode.

7. The system of claim 1, wherein the SBS module comprises a plurality of SBS modules, each configured to communicate independently with the control module through wireless communication.

8. The system of claim 7, wherein the SBS modules are configured to communicate independently with each other through wireless communication.

9. The system of claim 1, wherein the SBS module comprises a pulse generator.

10. The system of claim 1, wherein the SBS module comprises a bandstop filter electrically connectable with the stimulating and/or sensing electrode or their associated lead.

11. The system of claim 1, wherein the control module is configured to communicate with an external programmer or network through telemetric wireless communication.

12. The system of claim 11, wherein the control module is capable of permitting telemetric transmission of patient data to the external programmer or network.

13. The system of claim 12, wherein the transmitted patient data is selected from the group consisting of GPS data, current or historical-sensed patient biologic data, and current or historical therapy delivery data.

14. The system of claim 1, wherein, the processing circuit comprises a protection diode array.

15. The system of claim 1, wherein actuation, of the stimulating electrodes occurs by the processing circuit in response to a signal received from the control module.

16. The system of claim 1, wherein the SBS module is configured to transmit sensed biologic data to the control module, and the control module is configured to process biologic data to determine if therapy is required, and wherein when therapy is required, actuation instructions are transmittable by the control module to the SBS module.

17. The system of claim 16, wherein the transmittable instructions comprise stimulation electrode actuation timing and waveshape instructions.

18. The system of claim 16, wherein the SBS module is configured to intermittently transmit the sensed biologic data to the control module.

19. The system of claim 18, wherein the SBS module is configured to transmit the sensed biologic data to the control module only when pre-defined biologic data is detected by the SBS module.

20. The system of claim 1, wherein the SBS housing is fixable to a patient'"'"'s skull utilizing screws to prevent twisting of the SBS housing body.

21. The system of claim 1, wherein, the SBS housing comprises fixation tabs disposed within corresponding burr-hole recesses.

22. The system of claim 1, wherein the SES housing comprises a ceramic housing.

23. The system of claim 22, wherein the ceramic housing comprises an alumina ceramic housing.

24. The system of claim 22, wherein a lead for the electrode and/or an antenna extend through the housing.

25. The system of claim 1, wherein the SBS housing comprises a hermetic terminal through which an antenna extends.

26. The system of claim 25, wherein the SBS housing comprises at least one hermetic terminal through which a lead for the electrode extends.

27. The system of claim 1, comprises a circuit board disposed within the SBS housing, the circuit board having the first transceiver portion and being electronically connected to the power source, the electrodes and an RF antenna.

28. The system of claim 27, further comprising a protection diode array electronically connected to the circuit board.

29. The system of claim 27, further comprising a protection diode array electronically connected to the RF antenna.

30. The system of claim 27, wherein one or more of the electrodes serves as the RF antenna.

31. The system of claim 27, wherein the SBS housing comprises an exterior receptacle for an electrode lead plug, configured to permit an electrical connection between the electrode lead and the circuit board through the SBS housing.

32. The system of claim 1, wherein the first electrical power source and the second electrical power source are replaceable.

33. A satellite therapy delivery system for brain neuromodulation, comprising:

a) a control module comprising a first RF transceiver and a microprocessor electrically connected to a first power source positionable therewithin;

b) a satellite brain stimulation and/or sensing (SBS) module comprising;

i) at least one biologic stimulating and/or sensing electrode, a bandstop filter electrically connected to the at least one stimulating and/or sensing electrode;

ii) a biocompatible and hermetically sealed SBS housing; and

iii) a second power source disposed within the SBS housing, and a second RF transceiver for wireless communication with the control module electrically connected to the second power source; and

c) wherein the SBS housing body is configured to be positionable within a burr hole through a patient'"'"'s skull.

34. The system of claim 33, wherein the stimulating and/or sensing electrode of the SBS module is selected from the group consisting of a deep brain electrode, and a subcutaneous or subdural paddle, patch or pad electrode.

35. The system of claim 33, wherein the control module and the SBS module are configured to operate in a closed loop communication mode.

36. The system of claim 33, wherein the SBS module comprises a plurality of SBS modules, each configured to independently communicate with the control module or other SBS modules through wireless communication.

37. The system of claim 33, wherein the SBS module comprises a pulse generator.

38. The system of claim 33, wherein the control module is configured to communicate with an external programmer or network through wireless telemetric communication.

39. The system of claim 33, wherein the SBS module comprises a processing circuit electrically connected to the second RF transceiver and the second power source.

40. The system of claim 39, wherein actuation of the stimulating electrode occurs by the processing circuit in response to a signal received from the control module.

41. The system of claim 39, wherein the SBS module is configured to transmit sensed biologic data to the control module, and the control module is configured to process the biologic data to determine if therapy is required, and wherein when therapy is required, actuation instructions are transmittable by the control module to the SBS module.

42. A satellite therapy delivery system for brain neuromodulation, comprising:

a) a control module comprising a first RF transceiver and a microprocessor, the first receiver and the microprocessor electrically connected to a first power source positionable therewithin;

b) a satellite brain stimulation and/or sensing (SBS) module comprising;

i) at least one biologic stimulating and/or sensing electrode;

ii) a biocompatible and hermetically sealed SBS housing;

iii) a second power source and a second RF transceiver for wireless communication with the control module disposed within the housing body; and

iv) a circuit board disposed within the SBS module housing, the circuit board receiving the second RF transceiver portion and a processing circuit, the processing circuit being electronically connectable to the second power source, the electrodes and the second RF transceiver, wherein the processing circuit electrically connectable to a first protection diode array, a second protection diode array electronically connectable to the second RF transceiver; and

c) wherein the SBS housing body positionable within a burr hole through a patient'"'"'s skull.

43. The system of claim 42, wherein the stimulating and/or sensing electrode of the SBS module is selected from the group consisting of a deep brain electrode and a subcutaneous or subdural paddle, patch or pad electrode.

44. The system of claim 42, wherein the SBS module comprises a plurality of SES modules, each configured to independently communicate with the control module or other SFAS modules.

45. The system of claim 42, wherein the SBS module comprises a pulse generator.

46. The system of claim 42, wherein the control module is configured to communicate with an external programmer or network through telemetric wireless communication.

47. The system of claim 42, wherein actuation of the stimulating electrodes occurs by the processing circuit when a response to a signal is received from the control module.

48. The system of claim 42, wherein the SBS module is configured to transmit sensed biologic data to the control module, the control module configured to process the biologic data to determine if therapy is required, and wherein when therapy is required, actuation instructions are transmittable by the control module to the SBS module.

49. The system of claim 42, wherein the first electrical power source and the second electrical power source are replaceable.