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

• US 9,427,584 B2
• Filed: 11/10/2014
• Issued: 08/30/2016
• 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:
  US14/537,293
• Publication Number:
  US 20150134028A1
• Time in Patent Office: 659 Days
• US Class Current: 1/1
• 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

The present disclosure involves a method of generating different stimulation waveforms as a part of sacral nerve stimulation therapy. A first stimulation waveform having a first stimulation waveform characteristic is generated. The first stimulation waveform is delivered to a first body part of a patient at least in part via a first channel. A second stimulation waveform having a second stimulation waveform characteristic is generated. The second stimulation waveform characteristic is different from the first stimulation waveform characteristic. The second stimulation waveform is delivered to a second body part of the patient at least in part via a second channel that is separate and independent from the first channel. The first body part and second body part correspond to different organs or different types of nerves.

Claims

1. A method of generating different stimulation waveforms as a part of sacral nerve stimulation therapy, comprising:

providing a first clock via a first signal produced by a first crystal clock or via a first phase-locked-loop that is configured to convert a crystal clock signal into a first clock signal;

providing a second clock via a second signal produced by a second crystal clock different from the first crystal clock or via a second phase-locked-loop that is configured to convert the crystal clock signal into a second clock signal, wherein the first clock and the second clock are separate but are provided within a same device housing;

generating a first stimulation waveform as a first part of the sacral nerve stimulation therapy, the first stimulation waveform having a first stimulation waveform characteristic, wherein the first stimulation waveform is generated using the first clock;

delivering, at least in part via a first channel, the first stimulation waveform to a first body part of a patient;

generating a second stimulation waveform as a second part of the sacral nerve stimulation therapy, the second stimulation waveform having a second stimulation waveform characteristic different from the first stimulation waveform characteristic, wherein the second stimulation waveform is generated using the second clock; and

delivering, at least in part via a second channel that is separate and independent from the first channel, the second stimulation waveform to a second body part of the patient, wherein the first body part and second body part correspond to different organs or different types of nerves.

2. The method of claim 1, wherein the first stimulation waveform and the second stimulation waveform have different frequencies, pulse widths, or amplitudes.

3. The method of claim 1, wherein:

the delivering of the first stimulation waveform comprises delivering the first stimulation waveform to a sacral nerve of the patient; and

the delivering of the second stimulation waveform comprises delivering the second stimulation waveform to a pudendal nerve of the patient.

4. The method of claim 1, wherein at least one of the first stimulation waveform and the second stimulation waveform includes a superimposition of two or more distinct waveforms.

5. The method of claim 1, wherein:

the generating of the first and second stimulation waveforms are performed via a pulse generator, the pulse generator having an N number of output channels including the first and second channels;

the delivering of the first and second stimulation waveforms are further performed via a mesh electrode array that is electrically coupled to the output channels of the pulse generator; and

the mesh electrode array contains a M number of electrodes, M being greater than N.

6. The method of claim 5, further comprising:

routing the first channel to a first electrode on the mesh electrode array at a first point in time; and

routing the first channel to a second electrode on the mesh electrode array at a second point in time, wherein the first and second electrodes are different, and wherein the first and second points in time are different.

7. A medical system, comprising:

an electronic programmer configured to generate programming instructions; and

a pulse generator configured to generate, in response to the programming instructions, electrical pulses to be delivered to a patient as a part of a sacral nerve stimulation therapy;

wherein;

the pulse generator includes;

a microcontroller, a first channel, a second channel separate and independent from the first channel, a first clock, and a second clock different from the first clock, wherein the first clock and the second clock are within a same device housing;

the first clock comprises;

a first crystal clock configured to output a first clock signal, or a first phase-locked-loop that is configured to convert a crystal clock signal into a first clock signal;

the second clock comprises;

a second crystal clock configured to output a second clock signal different from the first clock signal, or a second phase-locked-loop that is configured to convert the crystal clock signal into a second clock signal different from the first clock signal;

the microcontroller is configured to generate, using the first clock, a first stimulation waveform as the electrical pulse to be outputted by the first channel as a first part of the sacral nerve stimulation therapy, the first stimulation waveform having a first stimulation waveform characteristic; and

the microcontroller is configured to generate, using the second clock, a second stimulation waveform as the electrical pulse to be outputted by the second channel as a second part of the sacral nerve stimulation therapy, the second stimulation waveform having a second stimulation waveform characteristic different from the first stimulation waveform characteristic.

8. The medical system of claim 7, further comprising:

a first electrode adapted to be positioned proximate to, and configured to deliver the first stimulation waveform to, a first body part of the patient; and

a second electrode adapted to be positioned proximate to, and configured to deliver the second stimulation waveform to, a second body part of the patient that is different from the first body part.

9. The medical system of claim 8, wherein:

the first electrode is adapted to be positioned proximate to a sacral nerve of the patient; and

the second electrode is adapted to be positioned proximate to a pudendal nerve of the patient.

10. The medical system of claim 8, wherein:

the pulse generator includes an N number of output channels including the first channel and the second channel;

the first electrode and the second electrode are elements of a mesh electrode array electrically coupled to the output channels of the pulse generator; and

the mesh electrode array contains a M number of electrodes, M being greater than N.

11. The medical system of claim 7, wherein the first stimulation waveform and the second stimulation waveform have different frequencies, pulse widths, or amplitudes.

12. The medical system of claim 7, wherein at least one of the first stimulation waveform and the second stimulation waveform includes a superimposition of two or more distinct waveforms.

13. A pulse generator configured to generate electrical pulses in response to programming instructions received from an electronic programmer, the pulse generator comprising:

a device housing;

a first clock and a second clock different from the first clock, the first clock and the second clock being within the device housing, wherein the first clock comprises;

a first crystal clock configured to output a first clock signal, or a first phase-locked-loop that is configured to convert a crystal clock signal into a first clock signal, and wherein the second clock comprises;

a second crystal clock configured to output a second clock signal different from the first clock signal, or a second phase-locked-loop that is configured to convert the crystal clock signal into a second clock signal different from the first clock signal;

a microcontroller coupled to the first clock and the second clock, the microcontroller being configured to generate a first stimulation waveform as a first part of a sacral nerve stimulation therapy and a second stimulation waveform as a second part of the sacral nerve stimulation therapy, the first stimulation waveform having a first frequency, the second stimulation waveform having a second frequency, wherein the microcontroller generates the first stimulation waveform using the first clock, and wherein the microcontroller generates the second stimulation waveform using the second clock;

a first channel configured to output the first stimulation waveform to a first electrode; and

a second channel configured to output the second stimulation waveform to a second electrode, wherein the first channel and the second channel are separate and independent of each other.

14. The pulse generator of claim 13, wherein:

the first stimulation waveform is configured to stimulate a sacral nerve of a patient; and

the second stimulation waveform is configured to stimulate a pudendal nerve of the patient.