SATELLITE THERAPY DELIVERY SYSTEM FOR BRAIN NEUROMODULATION

• US 20100125312A1
• Filed: 11/16/2009
• Published: 05/20/2010
• Est. Priority Date: 11/18/2008
• Status: Active Grant

• Current Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Winn, Steven W., Skwara, Thomas A., Siegler, Robert W., Frustaci, Dominick J., Frysz, Christine A., Stevenson, Robert A., Muffoletto, Barry C.
• Granted Patent: US 8,442,644 B2
• Time in Patent Office: Days
• US Class Current: 607/45
• 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 control module including an RF transmitter or transceiver; and

a satellite brain stimulation and/or sensing (SBS) module including biologic stimulating and/or sensing electrodes, a power source, and an RF receiver or transceiver for wireless communication with the control module.

2. The system of claim 1, wherein the control module is implanted within a patient'"'"'s body at a location remote from the SBS module

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

4. The system of claim 1, wherein the stimulating and/or sensing electrodes of the SBS module include a deep brain electrode, or subcutaneous or subdural paddle, patch or pad electrodes.

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

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

7. The system of claim 1, wherein the SBS module comprises a plurality of SBS modules, each capable of independent wireless communication with the control module.

8. The system of claim 7, wherein the SBS modules are capable of independent wireless communication with each other.

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

10. The system of claim 1, wherein the SBS module includes a bandstop filter associated with the stimulating and/or sensing electrodes or their associated leads.

11. The system of claim 1, wherein the control module includes telemetry for wirelessly communicating with an external programmer or network.

12. The system of claim 11, wherein the control module telemetry permits transmission of patient data to the external programmer or network.

13. The system of claim 12, wherein the transmitted patient data includes GPS data, current or historical-sensed patient biologic data, or current or historical therapy delivery data.

14. The system of claim 1, wherein the SBS module includes a processing circuit electrically coupled to the SBS module RF receiver or transceiver, and the power source.

15. The system of claim 14, where in the processing circuit includes a protection diode array.

16. The system of claim 14, where in the processing circuit actuates the stimulating electrodes in response to a signal received from the control module.

17. The system of claim 14, wherein the SBS module transmits sensed biologic data to the control module, the control module processes such biologic data to determine if therapy is required, and if therapy is required, the control module transmits actuation instructions to the SBS module.

18. The system of claim 17, wherein the transmitted instructions include stimulation electrode actuation timing and waveshape instructions.

19. The system of claim 17, wherein the SBS module transmits sensed biologic data to the control module intermittently.

20. The system of claim 19, wherein the SBS module transmits sensed biologic data to the control module only when pre-defined biologic data is detected.

21. The system of claim 1, wherein the SBS module comprises a biocompatible and hermetically sealed housing.

22. The system of claim 21, wherein the SBS module housing comprises a body and a removable cap.

23. The system of claim 22, including a biocompatible O-ring having a leak rate of no more than 10⁻

8 cubic centimeters per second.

24. The system of claim 22, wherein the SBS housing body is fixed within a burr hole through a patient'"'"'s skull.

25. The system of claim 24, wherein the cap of the SBS module housing is disposed generally co-planar with an outer surface of the patient'"'"'s skull.

26. The system of claim 25, wherein a skin flap overlies the cap of the SBS module housing, which can be easily removed to gain access to the cap and, upon removal of the cap, to a battery within the housing.

27. The system of claim 22, wherein the SBS housing is fixed to a patient'"'"'s skull utilizing screws to prevent twisting of the SBS housing body when the cap is removed.

28. The system of claim 24, wherein the SBS module housing includes fixation tabs disposed within corresponding burr-hole recesses.

29. The system of claim 21, wherein the SBS module housing comprises a ceramic housing.

30. The system of claim 29, wherein the ceramic housing comprises an alumina ceramic housing.

31. The system of claim 29, wherein leads for the electrodes and/or an antenna extend through the housing.

32. The system of claim 21, wherein the SBS housing includes a hermetic terminal through which an antenna extends.

33. The system of claim 32, wherein the SBS housing includes at least one hermetic terminal through which leads for the electrodes extend.

34. The system of claim 21, including a circuit board disposed within the SBS housing, the circuit board having a receiver or transceiver portion and being electronically coupled to the power source, the electrodes and an RF antenna.

35. The system of claim 34, including a protection diode array electronically coupled to the circuit board.

36. The system of claim 34, including a protection diode array electronically coupled to the RF antenna.

37. The system of claim 34, wherein one or more of the electrodes serves as the RF antenna.

38. The system of claim 34, wherein the SBS housing includes an exterior receptacle for an electrode lead plug, to permit electrical coupling between the electrode lead and the circuit board through the SBS housing.

39. The system of claim 1, wherein the power source for the SBS module comprises a replaceable battery module.

40. The system of claim 39, wherein the replaceable battery module comprises a biocompatible and hermetically sealed enclosure.

41. The system of claim 40, wherein the SBS module includes a biocompatible and hermetically sealed housing in which the battery module is disposed.

42. The system of claim 41, wherein the SBS module housing includes a removable cap permitting access to the replaceable battery module.