System and method for providing a waveform for stimulating biological tissue

• US 7,715,912 B2
• Filed: 09/15/2006
• Issued: 05/11/2010
• Est. Priority Date: 04/13/2005
• Status: Expired due to Fees

• Current Assignee: IntElect Medical, Inc. (Boston Scientific Corporation), Cleveland Clinic Foundation
• Original Assignee: IntElect Medical, Inc. (Boston Scientific Corporation), Cleveland Clinic Foundation
• Inventors: Wilder, Steven E., Fell, Roger Barraclough, Leyh, Scott Gordon, Carlton, Keith Richard, Rezai, Ali R.
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): PATTON, AMANDA K
• Application Number:
  US11/522,029
• Publication Number:
  US 20070078498A1
• Time in Patent Office: 1,334 Days
• Field of Search: 607/49
• US Class Current: 607/2
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An implantable programmable stimulator system includes memory that stores at least one waveform. A playback system provides an output waveform based on retrieving the at least one waveform from the memory. An output system is configured to drive at least one output channel based on the output waveform, the output system selecting the at least one output channel from a plurality of output channels in response to a selection signal.

Claims

1. An implantable programmable stimulator system comprising:

a plurality of waveform controllers, each waveform controller comprising;

memory containing non-parametric waveform data for at least one waveform preprogrammed to achieve electrical stimulation of biological tissue;

a playback system programmed to play back the non-parametric waveform data for the at least one preprogrammed waveform as at least one output waveform;

an output system that is configured to drive at least one output channel based on the output waveform, the output system selecting the at least one output channel from a plurality of output channels in response to a selection signal;

an amplifier system comprising a plurality of amplifiers, each amplifier electrically connected to the plurality of waveform controllers, the each amplifier receiving at least one output waveform from at least one waveform controller and outputting an amplified output waveform, wherein the each amplifier includes input circuitry to aggregate the received at least one output waveform from the at least one waveform controller; and

a system controller configured to provide control instructions to the each waveform controller, the control instructions including the selection signal and a designation of selective ones of the plurality of amplifiers for the each waveform controller to provide the corresponding at least one output waveform.

2. The system of claim 1, wherein the output system further comprises a switch network connected between the playback system and the plurality of channels, the switch network configured to complete an electrically conductive path from an output of the playback system and the at least one output channel in response to the selection signal.

3. The system of claim 1, wherein the plurality of amplifiers of the amplifier system comprise at least one amplifier electrically connected between the playback system and the output system.

4. The system of claim 3, wherein the amplifier system comprises a number of amplifiers that is less than a number of the plurality of output channels, such that the output system is configured to selectively distribute a corresponding amplified output waveform from at least one of the amplifiers to at least two of the plurality of output channels.

5. The system of claim 1, wherein the amplifier system comprises at least one amplifier coupled between the output system and the plurality of output channels.

6. The system of claim 1, further comprising a communication system that is configured to communicate data relative to the system controller, the system controller employing at least some of the data received by the communication system to program the at least one waveform in the memory of the each waveform controller of the plurality of waveform controllers.

7. The system of claim 1, further comprising a housing that encapsulates the plurality of waveform controllers, the amplifier system, and the system controller, wherein each of the plurality of output channels of the each waveform controller being electrically accessible via the housing.

8. The system of claim 1, further comprising a communication system that is configured to communicate data relative to the implantable programmable stimulator system for programming the memory.

9. The system of claim 8, wherein the communication system comprises a wireless communication system that employs security measures to mitigate unauthorized access to the memory.

10. The system of claim 1, wherein the memory stores the at least one waveform as a digital representation of an electrical waveform recorded from tissue of a biological subject.

11. The system of claim 1, wherein the output system is configured to scale the output waveform electronically.

12. The system of claim 1, wherein the playback system is programmed to scale at least one waveform parameter of the output waveform.

13. The system of claim 1, wherein the playback system of each waveform controller is configured to provide the output waveform according to a defined schedule.

14. The system of claim 13, wherein the defined schedule is periodic so that the output waveform is provided periodically to the output system.

15. The system of claim 1, wherein, for each waveform controller, the memory stores a plurality of waveforms, each of the plurality of waveforms being preprogrammed for stimulation of biological tissue, the playback system retrieves the at least one waveform selected from the plurality of preprogrammed waveforms to provide the output waveform.

16. The system of claim 15, wherein, for each waveform controller, the playback system is configured to provide the output waveform according to a defined schedule so that the output waveform is provided periodically to the output system.

17. The system of claim 15, wherein, for each waveform controller, the playback system is configured to selectively retrieve the at least one waveform from the memory and to provide the output waveform in response to a stimulus.

18. The implantable programmable stimulator system of claim 1, wherein the at least one preprogrammed waveform is a train of waveform pulses.

19. The implantable programmable stimulator system of claim 18, wherein the train of waveform pulses is arranged in a predetermined order, and wherein each waveform pulse is one of the at least one preprogrammed waveform and an aggregate waveform combined from the at least one preprogrammed waveform.

20. The implantable programmable stimulator system of claim 1, wherein the system controller is further configured to provide amplifier control signals that activate or deactivate an amplifier of the plurality of amplifiers.

21. The implantable programmable stimulator system of claim 1, wherein the each waveform controller further comprises a direct memory access (DMA) controller electrically connected to the memory, the DMA controller configured to write and retrieve blocks of data corresponding to the non-parametric waveform data to the memory in response to instructions from the system controller.

22. The system of claim 1, wherein for each of the plurality of waveform controllers:

the at least one waveform preprogrammed to achieve electrical stimulation of biological tissue stored in the memory is stored as compressed non-parametric waveform data encoded according to a predetermined codec; and

the playback system is further programmed to retrieve and decode the at least one preprogrammed waveform from the memory, the decoding of the at least one preprogrammed waveform performed pursuant to the predetermined codec.

23. An integrated implantable system for delivering electrical stimulation, comprising:

a plurality of waveform controllers, each waveform controller comprising;

means for retrieving non-parametric waveform data for a pre-recorded waveform preprogrammed to achieve electrical stimulation of biological tissue from memory;

means for playing back the non-parametric waveform data for the retrieved waveform as an output waveform; and

means for selectively distributing the output waveform to at least one of a plurality of channels;

a plurality of amplifying means, each amplifying means electrically connected to the plurality of waveform controllers, each amplifying means receiving at least one output waveform from at least one waveform controller and outputting an amplified output waveform, wherein each amplifying means includes means for aggregating the received at least one output waveform from the at least one waveform controller; and

control means to provide control instructions to the each waveform controller, the control instructions including the selection signal and a designation of selective ones of the plurality of amplifying means for each waveform controller to provide the corresponding at least one output waveform.

24. The system of claim 23, further comprising means for amplifying the output waveform, such that an amplified output waveform is provided to the at least one of the plurality of channels to deliver the electrical stimulation.

25. The system of claim 23, further comprising means for scaling the output waveform by adjusting at least one parameter of the output waveform.

26. The system of claim 23, wherein the means for retrieving is programmed to retrieve at least one of the recorded waveform from a plurality of recorded waveforms based on preprogrammed instructions.

27. The system of claim 23, further comprising:

means for housing the plurality of waveform controllers, the plurality of amplifying means, and the control means; and

means for providing electrical access to the plurality of channels of each waveform controller.

28. The system of claim 23, further comprising means for controlling the means for retrieving and for controlling the means for playing back.

29. The system of claim 23, further comprising means for communicating data wirelessly relative to the integrated implantable system.

30. The system of claim 23, wherein, for each waveform controller, the memory stores a plurality of waveforms preprogrammed for stimulation of biological tissue, wherein the means for retrieving retrieves at least one selected waveform that is selected from the plurality of waveforms stored in the memory.

31. The system of claim 30, wherein the means for playing back provides the output waveform to the means for selectively distributing based on the at least one selected waveform.