METHODS, SYSTEMS AND DEVICES FOR DETERMINING OPTIMAL PLACEMENT FOR PUDENDAL NERVE STIMULATION LEAD USING PATIENT FEEDBACK

• US 20150134027A1
• Filed: 11/10/2014
• Published: 05/14/2015
• Est. Priority Date: 11/08/2013
• Status: Active Grant

• Current Assignee: Cirtec Medical Corp.
• Original Assignee: Greatbatch Limited (Greatbatch Incorporated)
• Inventors: Kaula, Norbert, Iyassu, Yohannes, Siegel, Steven, Spinelli, Michele
• Granted Patent: US 9,504,830 B2
• Time in Patent Office: Days
• US Class Current: 607/41
• 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 measuring a physiological feedback from a patient in response to electrical stimulation. A stimulation parameter of a sacral nerve stimulation therapy is ramped up. The sacral nerve stimulation therapy includes electrical pulses generated by a pulse generator based on programming instructions received from an electronic programmer. The electrical pulses are delivered to a patient via a stimulation lead that is implanted in the patient. Via an anal electrode device that is at least partially inserted inside an anal canal of the patient, a compound motor action potential (CMAP) is measured from an anal sphincter of the patient while the stimulation parameter of the sacral nerve stimulation therapy is being ramped up. A stimulation threshold is determined based on the measured CMAP.

Claims

1. A medical system of measuring a physiological feedback from a patient in response to electrical stimulation, comprising:

an anal electrode device that is configured to be inserted into an anal canal of a patient, wherein the anal electrode device is configured to measure a compound motor action potential (CMAP) from an anal sphincter of the patient while a sacral nerve stimulation therapy is delivered to the patient;

a stimulation lead having a plurality of electrode contacts, wherein the stimulation lead is implantable inside the patient;

a pulse generator electrically coupled to the stimulation lead, wherein the pulse generator is configured to generate electrical pulses of the sacral nerve stimulation therapy to be delivered by one or more of the electrode contacts to the patient; and

an electronic programmer telecommunicatively coupled to the pulse generator, wherein the electronic programmer is configured to program the pulse generator to generate the electrical pulses, and wherein the electronic programmer is configured to;

ramp up a stimulation parameter of the sacral nerve stimulation therapy;

receive measurements of the CMAP as the stimulation parameter of the sacral nerve stimulation therapy is being ramped up; and

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

2. The medical system of claim 1, wherein the electronic programmer is further configured to:

offer instructions on adjusting a placement of the stimulation lead in response to the determined stimulation threshold.

3. The medical system of claim 2, wherein the electronic programmer is configured to offer the instructions by displaying graphical or textual instructions via a graphical user interface of the electronic programmer.

4. The medical system of claim 1, wherein the electronic programmer is further configured to:

recommend a value of the stimulation parameter corresponding to the stimulation threshold as a starting value for the stimulation parameter for a stimulation program.

5. The medical system of claim 1, wherein the stimulation parameter being ramped up includes a stimulation amplitude or a stimulation pulse width.

6. The medical system of claim 1, wherein the stimulation lead includes a plurality of electrode contacts, and wherein the electronic programmer is further configured to repeat the ramp up of the stimulation parameter, the receiving of the measurements of the CMAP, and the determination of the stimulation threshold for each of the electrode contacts.

7. The medical system of claim 1, wherein the anal electrode device includes:

a first ring of sensory electrodes corresponding to an internal sphincter of the patient; and

a second ring of sensory electrodes corresponding to an external sphincter of the patient.

8. The medical system of claim 1, wherein the anal electrode device includes an inflatable balloon.

9. A method of measuring a physiological feedback from a patient in response to electrical stimulation, comprising:

ramping up a stimulation parameter of a sacral nerve stimulation therapy, wherein the sacral nerve stimulation therapy includes electrical pulses generated by a pulse generator based on programming instructions received from an electronic programmer, and wherein the electrical pulses are delivered to a patient via a stimulation lead that is implanted in the patient;

measuring, via an anal electrode device that is at least partially inserted inside an anal canal of the patient, a compound motor action potential (CMAP) from an anal sphincter of the patient while the stimulation parameter of the sacral nerve stimulation therapy is being ramped up; and

determining a stimulation threshold based on the measured CMAP.

10. The method of claim 9, further comprising offering instructions on adjusting a placement of the stimulation lead in response to the determining.

11. The method of claim 10, wherein the offering comprises displaying graphical or textual instructions via a graphical user interface of the electronic programmer.

12. The method of claim 9, further comprising:

recommending a value of the stimulation parameter corresponding to the stimulation threshold as a starting value for the stimulation parameter in a stimulation program.

13. The method of claim 9, wherein the stimulation parameter being ramped up includes a stimulation amplitude or a stimulation pulse width.

14. The method of claim 9, wherein the stimulation lead includes a plurality of electrode contacts, and further comprising repeating the ramping up, the measuring, and the determining for each of the electrode contacts.

15. The method of claim 9, wherein:

the anal electrode device includes;

a first ring of sensory electrodes corresponding to an internal sphincter of the patient; and

a second ring of sensory electrodes corresponding to an external sphincter of the patient; and

the measuring comprises obtaining the CMAP from at least one of the sensory electrodes of the first ring or the second ring.

16. The method of claim 9, wherein the anal electrode device includes an inflatable balloon.

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

an elongate 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;

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; and

an inflatable balloon at a distal portion of the anal electrode device, the balloon being inflatable to inhibit removal of the anal electrode device from within the patient.

18. The anal electrode device of claim 17, wherein the anchor includes an oblong component at an end portion of the anal electrode device, 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.

19. The anal electrode device of claim 17, 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.

20. The anal electrode device of claim 17, wherein the first and second sensory electrodes are rotatable and slidable.