Satellite therapy delivery system for brain neuromodulation

• US 8,792,987 B2
• Filed: 04/08/2013
• Issued: 07/29/2014
• 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:
  US13/858,268
• Publication Number:
  US 20130226262A1
• Time in Patent Office: 477 Days
• Field of Search: 607 1- 2, 607/45, 607/60, 607115-116, 607/118, 607/139
• 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) a satellite brain stimulation and/or sensing (SBS) module comprising;

i) at least one biologic stimulating and sensing electrode;

ii) an SBS housing;

iii) a first electrical power source disposed within the SBS housing;

iv) a first RF transceiver disposed within the SBS housing and powered by the first electrical power source; and

v) an SBS processing circuit powered by the first electrical power source, wherein the SBS processing circuit is electrically connected to the first RF transceiver;

b) a control module capable of analyzing an SBS RF wireless signal, the control module comprising;

i) a control module housing;

ii) a second electrical power source;

iii) a second RF transceiver; and

iv) a microprocessor,

v) wherein the second RF transceiver and the microprocessor are disposed within the control module housing and powered by the second electrical power source,

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

d) wherein the at least one electrode is actuatable by the SBS processing circuit in response to an RF wireless signal having been firstly received by the SBS module and secondly analyzed by the control module,

e) wherein the SBS module is configurable for RF wireless transmission of sensed biologic data from the at least one electrode to the control module,

f) wherein the control module is configurable to process transmitted 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, and

g) wherein the actuation instructions that are transmittable by the control module to the SBS module comprise instructions to actuate stimulation timing and stimulation waveform of the at least one electrode.

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 configurable to be externally worn by a patient having an implanted SBS module.

4. The system of claim 1, wherein the at least one electrode is 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 configurable to operate in an open loop communication mode.

6. The system of claim 1, wherein the control module and the SBS module are configurable 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 SBS module being configurable to communicate independently with the control module through wireless communication.

8. The system of claim 7, wherein the plurality of SBS modules are configurable 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 control module is configurable to communicate with an external programmer or network through telemetric wireless communication.

11. The system of claim 10, wherein the control module is configured to permit telemetric transmission of patient data to the external programmer or network.

12. The system of claim 11, 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.

13. The system of claim 1, wherein the at least one electrode is a stimulating electrode that is actuatable by the SBS processing circuit in response to a signal received from the control module.

14. The system of claim 1, wherein the SBS module is configurable to intermittently transmit sensed biologic data from the at least one electrode as a biological sensing electrode to the control module.

15. The system of claim 14, wherein the SBS module is configurable to transmit the sensed biologic data to the control module only when pre-defined biologic data is detected by the SBS module.

16. 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.

17. The system of claim 1, wherein the SBS housing comprises fixation tabs that are disposable within corresponding burr-hole recesses.

18. The system of claim 1, wherein the SBS housing comprises a ceramic housing.

19. The system of claim 18, wherein the ceramic housing comprises an alumina ceramic housing.

20. The system of claim 1, wherein a lead for the at least one electrode and/or for an antenna extends through the SBS housing.

21. The system of claim 20, wherein the SBS housing comprises a hermetic terminal through which the lead extends.

22. The system of claim 1, wherein the SBS housing comprises at least one hermetic terminal through which a lead electrically connected to the at least one electrode extends.

23. The system of claim 1, wherein a circuit board is disposed within the SBS housing, the circuit board comprising the first RF transceiver and being electronically connected to the first power source, the at least one electrode, and an RF antenna.

24. The system of claim 1, wherein the at least one electrode serves as an RF antenna.

25. The system of claim 1, wherein the SBS housing comprises an exterior receptacle for an electrode lead plug, and wherein the exterior receptacle is configured to provide an electrical connection through the SBS housing from a lead extending from a lead distal end electrically connected to the at least one electrode to a lead proximal plug end received in the receptacle and then to a circuit board disposed within the SBS housing.

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

27. 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 electrode;

ii) at least one sensing electrode;

iii) an SBS housing;

iv) a first electrical power source disposed within the SBS housing;

v) a first RF transceiver disposed within the SBS housing and powered by the first electrical power source; and

vi) an SBS processing circuit powered by the first electrical power source, wherein the SBS processing circuit is electrically connected to the first RF transceiver;

b) a control module capable of analyzing an SBS RF wireless signal, the control module comprising;

i) a control module housing;

ii) a second electrical power source;

iii) a second RE′

transceiver; and

iv) a microprocessor,

v) wherein the second RF transceiver and the microprocessor are disposed within the control module housing and powered by the second electrical power source,

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

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

e) wherein the SBS module is configurable for RF wireless transmission of sensed biologic data from the at least one sensing electrode to the control module,

f) is wherein the control module is configurable to process transmitted 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, and

g) wherein the actuation instructions that are transmittable by the control module to the SBS module comprise instructions to actuate stimulation timing and stimulation waveform of the at least one stimulation electrode.

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

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

i) at least one leadwire physically and electrically connected to at least one biologic stimulating and/or sensing electrode;

ii) an SBS housing;

iii) a first electrical power source disposed within the SBS housing;

iv) a first RF transceiver disposed within the SBS housing and powered by the first electrical power source; and

v) an SBS processing circuit powered by the first electrical power source, wherein the SBS processing circuit is electrically connected to the first RF transceiver;

b) a control module capable of analyzing an SBS RF wireless signal, the control module comprising;

i) a control module housing;

ii) a second electrical power source;

iii) a second RF transceiver; and

iv) a microprocessor,

v) wherein the second RF transceiver and the microprocessor are disposed within the control module housing and powered by the second electrical power source,

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

d) wherein the at least one electrode is actuatable by the SBS processing circuit in response to an RF wireless signal having been firstly received at the SBS module from the at least one leadwire serving as an RF antenna and secondly analyzed by the control module,

e) wherein the SBS module is configurable for RF wireless transmission of sensed biologic data from the at least one electrode to the control module,

f) wherein the control module is configurable to process transmitted 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, and

g) wherein the actuation instructions that are transmittable by the control module to the SBS module comprise instructions transmitted along the at least one leadwire to actuate stimulation timing and stimulation waveform of the at least one electrode.