Methods, systems and devices for determining optimal placement for pudendal nerve stimulation lead using patient feedback

• US 10,238,877 B2
• Filed: 11/21/2016
• Issued: 03/26/2019
• Est. Priority Date: 11/08/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Nuvectra Corporation
• Inventors: Kaula, Norbert, Iyassu, Yohannes, Siegel, Steven, Spinelli, Michele
• Primary Examiner(s): Dietrich, Joseph M
• Application Number:
  US15/356,772
• Publication Number:
  US 20170065820A1
• Time in Patent Office: 855 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

An anal electrode device is configured to measure a response of a patient to a stimulation pulse. The anal electrode device includes an elongated shaft that is configured to be at least partially inserted into an anal canal of the patient. A first sensory electrode is disposed on a first region of the shaft. The first sensory electrode is configured to measure a compound motor action potential (CMAP) from an internal sphincter of the patient while the shaft is partially inserted into the anal canal of the patient. A second sensory electrode is disposed on a second region of the shaft. The second sensory electrode is configured to measure the CMAP from an external sphincter of the patient while the shaft is partially inserted into the anal canal of the patient.

Claims

1. An anal electrode device configured to measure a response of a patient to a stimulation pulse, the anal electrode device comprising:

an elongated shaft that is configured to be at least partially inserted into an anal canal of the patient;

a first sensory electrode disposed on a first region of the shaft, wherein the first sensory electrode is configured to measure a compound motor action potential (CMAP) from an internal sphincter of the patient while the shaft is partially inserted into the anal canal of the patient; and

a second sensory electrode disposed on a second region of the shaft, wherein the second sensory electrode is configured to measure the CMAP from an external sphincter of the patient while the shaft is partially inserted into the anal canal of the patient.

2. The anal electrode device of claim 1, wherein the anal electrode device further includes an oblong component, the oblong component being shaped to fit between buttocks of the patient to hold the anal electrode device in a first orientation with respect to the patient.

3. The anal electrode device of claim 1, further comprising:

a first ring of sensory electrodes disposed on the first region of the shaft, the first sensory electrode being in the first ring; and

a second ring of sensory electrodes disposed on the second region of the shaft, the second sensory electrode being in the second ring.

4. The anal electrode device of claim 1, wherein the first sensory electrode and the second sensory electrode are each rotatable with respect to an end portion of the anal electrode device.

5. The anal electrode device of claim 1, wherein the first sensory electrode and the second sensory electrode are each slidable with respect to an end portion of the anal electrode device.

6. The anal electrode device of claim 1, further comprising an inflatable balloon configured to inhibit removal of the anal electrode device from within the patient.

7. The anal electrode device of claim 1, wherein the anal electrode device is customized for the patient such that a shape of the elongated shaft conforms to the anal canal of the patient.

8. A medical system, comprising:

a pulse generator configured to generate electrical pulses as a part of an electrical stimulation therapy for a patient;

a programming device configured to send programming instructions to the pulse generator to generate the electrical pulses;

an anal electrode device configured to measure a compound motor action potential (CMAP) of the patient in response to the electrical pulses generated by the pulse generator, wherein the anal electrode device includes;

an elongated shaft that is configured to be at least partially inserted into an anal canal of the patient;

a first sensory electrode disposed on a first region of the shaft, wherein the first sensory electrode is configured to measure a compound motor action potential (CMAP) from an internal sphincter of the patient while the shaft is partially inserted into the anal canal of the patient; and

a second sensory electrode disposed on a second region of the shaft, wherein the second sensory electrode is configured to measure the CMAP from an external sphincter of the patient while the shaft is partially inserted into the anal canal of the patient.

9. The medical system of claim 8, wherein the anal electrode device further includes an oblong component, the oblong component being shaped to fit between buttocks of the patient to hold the anal electrode device in a first orientation with respect to the patient.

10. The medical system of claim 8, the anal electrode device further includes:

a first ring of sensory electrodes disposed on the first region of the shaft, the first sensory electrode being in the first ring; and

a second ring of sensory electrodes disposed on the second region of the shaft, the second sensory electrode being in the second ring.

11. The medical system of claim 8, wherein the first sensory electrode and the second sensory electrode are each rotatable with respect to an end portion of the anal electrode device.

12. The medical system of claim 8, the first sensory electrode and the second sensory electrode are each slidable with respect to an end portion of the anal electrode device.

13. The medical system of claim 8, wherein the anal electrode devices further includes an inflatable balloon configured to inhibit removal of the anal electrode device from within the patient.

14. The medical system of claim 8, wherein the programming device is configured to program the pulse generator to:

receive measurements of the CMAP from the anal electrode device in response to the electrical pulses; and

determine a stimulation threshold based on the received measurements of the CMAP.

15. A method, comprising:

inserting an anal electrode device into an anal canal of a patient, wherein the anal electrode device includes one or more sensory electrodes that are configured to come into contact with a sphincter of the patient after the anal electrode device has been inserted into the anal canal;

programming a pulse generator to generate electrical pulses to stimulate a sacral nerve or a pudendal nerve of the patient; and

measuring, at least in part via the one or more sensory electrodes, a compound motor action potential (CMAP) from the sphincter of the patient in response to the electrical pulses generated by the pulse generator.

16. The method of claim 15, wherein the inserting comprises:

deflating a balloon of the anal electrode device before the inserting;

inserting the anal electrode device while the balloon remains deflated; and

inflating the balloon after the anal electrode device has been inserted.

17. The method of claim 15, further comprising:

preventing, after the inserting, a movement of the anal electrode device via an oblong end of the anal electrode device.

18. The method of claim 15, further comprising:

scanning an anatomical image of the patient; and

configuring a shape of a shaft of the anal electrode device according to the anatomical image.

19. The method of claim 15, wherein:

the anal electrode device includes a first ring of sensory electrodes and a second ring of sensory electrodes;

measuring the CMAP from an internal sphincter of the patient at least in part using the first ring of sensory electrodes; and

measuring the CMAP from an external sphincter of the patient at least in part using the second ring of sensory electrodes.

20. The method of claim 15, further comprising determining a stimulation threshold based on the measured CMAP.