IPG configured to deliver different pulse regimes to different leads for pudendal nerve stimulation

• US 10,080,897 B2
• Filed: 06/01/2017
• Issued: 09/25/2018
• Est. Priority Date: 11/08/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Iyassu, Yohannes, Labbe, Michael
• Primary Examiner(s): FAIRCHILD, MALLIKA DIPAYAN
• Application Number:
  US15/610,898
• Publication Number:
  US 20170266437A1
• Time in Patent Office: 481 Days
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0512 Anal electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A pulse generator is configured to generate electrical pulses of an electrical stimulation therapy. The pulse generator includes an N number of output channels and a microcontroller configured to generate instructions. The pulse generator is configured to generate different stimulation waveforms simultaneously for the output channels. The different waveforms have different waveform characteristics. A mesh electrode array includes an M number of electrodes. Each of the electrodes is configured to deliver the electrical pulses of the electrical stimulation therapy. M is at least several times greater than N. A solid state relay contains a plurality of controllable switches that is each configured to be turned on or off in response to the instructions received from the microcontroller, such that the solid state relay routes the output channels of the pulse generator to different subset of the electrodes of the mesh electrode array at different points in time.

Claims

1. A medical system, comprising:

a pulse generator configured to generate electrical pulses of an electrical stimulation therapy, wherein the pulse generator includes a first number of output channels, the output channels each being configured to output the electrical pulses;

a mesh electrode array that includes a second number of electrodes, wherein each of the electrodes is configured to deliver the electrical pulses to a patient; and

a relay that is coupled between the mesh electrode array and the output channels of the pulse generator, the relay including a plurality of switches that are individually controllable, wherein the switches of the relay are configured to be turned on or off to provide electrical routing between the output channels of the pulse generator and the electrodes of the mesh electrode array;

wherein the relay is configured to electrically route each of the electrodes in at least a subset of the electrodes to different output channels at different points in time.

2. The medical system of claim 1, wherein the relay is located outside of the pulse generator and outside of the mesh electrode array.

3. The medical system of claim 1, wherein the second number is greater than the first number.

4. The medical system of claim 3, wherein a total number of the switches is equal to the first number multiplied by the second number, and wherein the relay is configured to provide electrical routing between each of the output channels and each of the electrodes.

5. The medical system of claim 1, wherein the plurality of switches include a plurality of solid-state switches.

6. The medical system of claim 1, further comprising a microcontroller that is configured to generate instructions, and wherein the switches are configured to be turned on or off in response to the instructions generated by the microcontroller to provide the electrical routing.

7. The medical system of claim 1, wherein the pulse generator is configured to output a first one of the electrical pulses via a first one of the output channels and to output a second one of the electrical pulses via a second one of the output channels, and wherein the first electrical pulse and the second electrical pulse have different waveform characteristics.

8. The medical system of claim 7, wherein the pulse generator is configured to output the first electrical pulse and the second electrical pulse simultaneously.

9. The medical system of claim 1, wherein at least one of the electrical pulses has a waveform that is a superimposition of multiple types of waveforms.

10. The medical system of claim 1, wherein at least one of the electrodes is positioned to stimulate a sacral nerve of the patient, and while at least another one of the electrodes is positioned to stimulate a pudendal nerve of the patient.

11. A medical system, comprising:

a pulse generator configured to generate electrical pulses of an electrical stimulation therapy, wherein the pulse generator includes an N number of separate and independent output channels that are configured to output different ones of the electrical pulses;

a mesh electrode array that includes an M number of electrodes, wherein each of the electrodes is configured to deliver any one of the electrical pulses to a patient, and wherein M is at least several times greater than N;

a microcontroller configured to generate instructions; and

an M×

N relay that is coupled between the mesh electrode array and the output channels of the pulse generator, the M×

N relay including a plurality of switches that are individually controllable in response to the instructions from the microcontroller to establish an electrical connection between each of the output channels of the pulse generator and each of the electrodes of the mesh electrode array;

wherein the M×

N relay is configured to electrically route each of the electrodes in at least a subset of the M number of electrodes to different output channels at different points in time.

12. The medical system of claim 11, wherein the M×

N relay is not a part of the pulse generator.

13. The medical system of claim 12, wherein the M×

N relay is not a part of the mesh electrode array.

14. The medical system of claim 11, wherein the M×

N relay includes a plurality of programmable solid state transistor switches that are each configured to turn on and off based on instructions from the microcontroller.

15. The medical system of claim 11, wherein:

the pulse generator is configured to simultaneously output a first electrical pulse via a first output channel and a second electrical pulse via a second output channel; and

the first electrical pulse and the second electrical pulse have different waveform characteristics.

16. The medical system of claim 15, wherein:

the waveform characteristic of the first electrical pulse is configured to stimulate a sacral nerve of the patient; and

the waveform characteristic of the second electrical pulse is configured to stimulate a pudendal nerve of the patient.

17. The medical system of claim 11, wherein at least one of the electrical pulses has a waveform that is a superimposition of one or more square waves and one or more sine waves.

18. A method, comprising:

generating, via a pulse generator, electrical pulses of an electrical stimulation therapy, wherein the pulse generator includes an N number of output channels; and

electrically routing, based on instructions from a microcontroller and via a relay having M×

N number of programmable switches, the output channels of the pulse generator to a mesh electrode array having an M number of electrodes, wherein the relay is coupled between the mesh electrode array and the output channels of the pulse generator, wherein M is at least several times greater than N, and wherein the relay is separate and different from the pulse generator and the mesh electrode array, and wherein the relay is configured to electrically route each of the electrodes of at least a subset of the M number of electrodes to different output channels at different points in time.

19. The method of claim 18, further comprising:

stimulating a sacral nerve of a patient by delivering, via a first electrode of the mesh electrode array, a first type of electrical pulse outputted by a first output channel of the pulse generator; and

stimulating a pudendal nerve of the patient by delivering, via a second electrode of the mesh electrode array, a second type of electrical pulse outputted by a second output channel of the pulse generator;

wherein the stimulating the sacral nerve and the stimulating the pudendal nerve are performed simultaneously.

20. The method of claim 18, wherein the electrical routing comprises individually turning on and off each of the programmable switches of the relay to establish electrical connections between each of the output channels and each of the electrodes.