Implantable pulse generator that generates spinal cord stimulation signals for a human body

• US 9,717,911 B2
• Filed: 10/31/2016
• Issued: 08/01/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Globus Medical, Inc.
• Inventors: Biele, Christopher, Angara, Raghavendra, Khalil, Saif
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/338,575
• Publication Number:
  US 20170043164A1
• Time in Patent Office: 274 Days
• Field of Search: 607 46
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36178 Burst or pulse train 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
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable pulse generator (IPG) that generates spinal cord stimulation signals for a human body has a programmable signal generator that can generate the signals based on stored signal parameters without any intervention from a processor that controls the overall operation of the IPG. While the signal generator is generating the signals the processor can be in a standby mode to substantially save battery power.

Claims

1. A method of generating spinal cord stimulation signals for a human body by an implantable pulse generator (IPG) including a processor and a programmable signal generator, the method comprising:

transmitting, by a treatment control module executed by the processor, one or more stimulation signal parameters to the programmable signal generator;

storing the one or more stimulation signal parameters in at least one control register of the programmable signal generator;

generating, by the programmable signal generator, one or more stimulation signals based on the one or more stimulation signal parameters;

transmitting the one or more stimulation signals to at least one electrode of the IPG;

placing, by the treatment control module, the processor in a standby mode, wherein the programmable signal generator generates the one or more stimulation signals without intervention from the processor while the processor is in the standby mode.

2. The method of claim 1, further comprising wirelessly receiving through a transceiver module a command from a remote control to power up the processor from the standby mode.

3. The method of claim 1, wherein the step of placing the processor in the standby mode causes a master clock of the processor to be disabled.

4. The method of claim 1, wherein the generation of the one or more stimulation signals include concurrently generating stimulation signal patterns for a plurality of programmable channels with each channel capable of being associated with at least two electrodes among a plurality of electrodes and with each channel representing a stimulation pattern of the associated electrodes.

5. The method of claim 4, wherein each channel is associated with one or more stored signal parameters, and wherein the one or more stored signal parameters include:

a channel length; and

a rising edge time of a pulse in the stimulation pattern associated each channel.

6. The method of claim 5, wherein the one or more stored signal parameters further include:

a channel rising edge time; and

a falling edge time of the pulse.

7. The method of claim 4, wherein for each channel, one or more control registers store which of the electrodes are associated with each channel such that an electrode among the plurality of electrodes can be associated with two or more channels.

8. The method of claim 1, wherein the generation of the stimulation signals include:

generating timing signals representing the stimulation signals according to one or more stored signal parameters;

continuously receiving the generated timing signals and selecting one channel among the plurality of channels as an active treatment channel.

9. The method of claim 1, wherein the generation of the stimulation signals include:

generating timing signals representing the stimulation signals according to the stored signal parameters;

determining whether to modulate the timing signals received from the timing generator; and

if it is determined that the timing signals are to be modulated, modulating the received timing signals at a burst frequency according to burst parameters stored in the registers.

10. The method of claim 1,

wherein the at least one electrode is disposed in an epidural space.

11. A method of generating spinal cord stimulation signals for a human body by an implantable pulse generator (IPG) including a processor and a programmable signal generator having a plurality of registers for storing stimulation signal parameters and the programmable signal generator adapted to generate the stimulation signals based on the stored signal parameters, the method comprising:

transmitting, by a treatment control module executed by the processor, the stimulation signal parameters to the programmable signal generator for storage in the plurality of registers;

storing the stimulation signal parameters in the control registers;

generating, by the programmable signal generator, one or more stimulation signals based on the stimulation signal parameters;

transmitting the one or more stimulation signals to at least one electrode of the IPG;

placing, by the treatment control module, the processor in a standby mode, wherein the programmable signal generator generates the stimulation signals according to the stored signal parameters without intervention from the processor while the processor is in the standby mode.

12. The method of claim 11, further comprising wirelessly receiving through a transceiver module a command from a remote control to wake up the processor from the standby mode.

13. The method of claim 11, wherein the step of placing the processor in the standby mode causes a master clock of the processor to be disabled.

14. The method of claim 11, wherein the generation of the stimulation signals include concurrently generating stimulation signal patterns for a plurality of programmable channels with each channel capable of being associated with at least two electrodes among a plurality of electrodes and with each channel representing a stimulation pattern of the associated electrodes.

15. The method of claim 14, wherein for each channel, the stored signal parameters include:

a channel length; and

a rising edge time of a pulse in the stimulation pattern associated with the each channel.

16. The method of claim 15, wherein the stored signal parameters further include:

a channel rising edge time; and

a falling edge time of the pulse.

17. The method of claim 14, wherein for each channel, the control registers store which of the electrodes are associated with the each channel such that an electrode among the plurality of electrodes can be associated with two or more channels.

18. The method of claim 11, wherein the generation of the stimulation signals include:

generating timing signals representing the stimulation signals according to the stored signal parameters;

continuously receiving the generated timing signals and selecting one channel among the plurality of channels as an active treatment channel.

19. The method of claim 11, wherein the generation of the stimulation signals include:

generating timing signals representing the stimulation signals according to the stored signal parameters;

determining whether to modulate the timing signals received from the timing generator; and

if it is determined that the timing signals are to be modulated, modulating the received timing signals at a burst frequency according to burst parameters stored in the registers.

20. The method of claim 11,

wherein the at least one electrode is disposed in an epidural space.