Method and system for monitoring and treating a medical condition via posterior tibial nerve stimulation

Patent metadata

Field	Value
Publication number	US-10478612-B2
Application number	US-201515523128-A
Country	US
Kind code	B2
Filing date	Oct 28, 2015
Priority date	Oct 31, 2014
Publication date	Nov 19, 2019
Grant date	Nov 19, 2019

Abstract

Various systems and methods for non-invasively monitoring and treating a medical condition of interest via transcutaneous stimulation of a target nerve are described. For instance, a subject can be monitored for improvement of a medical condition, where such improvement corresponds with a decrease in the threshold level at which a sensory or motor response is elicited in a subject upon stimulation as compared to a baseline level. Further, transcutaneous stimulation of the nerve can also treat the condition. Both monitoring and treatment can be carried out in a non-invasive manner substantially free of a painful response via electrical nerve stimulation of a target nerve, where the stimulation is delivered from an electrode placed on a non-glabrous skin surface. The electrode placement sufficiently immobilizes the target nerve such that the stimulation is effective and can be delivered in a controlled manner.

First claim

What is claimed is:

1. A method for non-invasively monitoring a medical condition in a subject, the method comprising:
positioning a first electrode adjacent to a surface of non-glabrous skin, wherein the non-glabrous skin is located at a first ankle of the subject proximate a first medial malleolus, wherein the first electrode is a cathode;
positioning a second electrode adjacent to a surface of glabrous skin, wherein in the second electrode is an anode spaced apart a predetermined distance from the first electrode;
transcutaneously delivering a first electrical nerve stimulation to a target nerve via the first electrode and the second electrode;
determining a baseline current or a baseline voltage for the subject, wherein the baseline current is the current at which a sensory response or a motor response is elicited in the subject as a result of the first electrical nerve stimulation, and wherein the baseline voltage is the voltage at which a sensory response or a motor response is elicited in the subject;
transcutaneously delivering a second electrical nerve stimulation to the target nerve via the first electrode and the second electrode;
determining a threshold current or a threshold voltage for the subject, wherein the threshold current is the current at which a sensory response or a motor response is elicited in the subject as a result of the second electrical nerve stimulation, and wherein the threshold voltage is the voltage at which a sensory response or a motor response is elicited in the subject; and
comparing the threshold current to the baseline current or the threshold voltage to the baseline voltage, wherein the medical condition is improved if the threshold current is lower than the baseline current or the threshold voltage is lower than the baseline voltage.

2. The method of claim 1 , wherein the non-glabrous skin at least partly overlies a flexor retinaculum.

3. The method of claim 2 , wherein the non-glabrous skin at least partly overlies a cephalic border of the flexor retinaculum.

4. The method of claim 1 , further comprising positioning a compressive device over the first electrode to immobilize the target nerve.

5. The method of claim 4 , wherein the compressive device includes a gel compression bead or a strap.

6. A system for non-invasively monitoring a medical condition in a subject via stimulation of a target nerve, the system comprising:
a first electrode, wherein the first electrode is configured for placement on a surface of non-glabrous skin, wherein the non-glabrous skin is located at an ankle of the subject proximate a medial malleolus, wherein the first electrode is a cathode;
a second electrode, wherein the second electrode is configured for placement on a surface of glabrous skin, wherein the second electrode is an anode; and
an electronic control system coupled to the first electrode and the second electrode, wherein the electronic control system is configured to:
transcutaneously deliver a first electrical nerve stimulation to the target nerve via the first electrode and the second electrode to determine a baseline current or a baseline voltage for the subject, wherein the baseline current is the current at which a sensory response or a motor response is elicited in the subject as a result of the first electrical nerve stimulation, and wherein the baseline voltage is the voltage at which a sensory response or a motor response is elicited in the subject; and
transcutaneously deliver a second electrical nerve stimulation to the target nerve via the first electrode and the second electrode to determine a threshold current or a threshold voltage for the subject, wherein the threshold current is the current at which a sensory response or a motor response is elicited in the subject as a result of the second electrical nerve stimulation, and wherein the threshold voltage is the voltage at which a sensory response or a motor response is elicited in the subject, wherein the medical condition is improved if the threshold current is lower than the baseline current or the threshold voltage is lower than the baseline voltage.

7. The system of claim 6 , wherein the non-glabrous skin at least partly overlies a flexor retinaculum.

8. The system of claim 7 , wherein the non-glabrous skin at least partly overlies a cephalic border of the flexor retinaculum.

9. The system of claim 6 , further comprising a compressive device, wherein the compressive device is configured for placement over the first electrode to immobilize the target nerve.

10. The system of claim 9 , wherein the compressive device includes a gel compression bead or a strap.

11. The system of claim 6 , further comprising a brace.

12. A method for treating a medical condition in a subject by transcutaneously delivering electrical nerve stimulation to the subject to stimulate a target nerve, the method comprising:
positioning a first electrode adjacent to a surface of non-glabrous skin, wherein the non-glabrous skin is located at a first ankle of the subject proximate a first medial malleolus, wherein the first electrode is a cathode;
positioning a second electrode adjacent to a surface of glabrous skin, where in the second electrode is a ground electrode spaced apart a predetermined distance from the first electrode; and
transcutaneously delivering a first electrical nerve stimulation to the target nerve via the first electrode and the second electrode.

13. The method of claim 12 , wherein the non-glabrous skin at least partly overlies a first flexor retinaculum.

14. The method of claim 13 , wherein the non-glabrous skin at least partly overlies a cephalic border of the first flexor retinaculum.

15. The method of claim 12 , further comprising stimulating a second target nerve, the method comprising:
positioning a third electrode adjacent to a surface of non-glabrous skin, wherein the third electrode is a cathode;
positioning a fourth electrode adjacent to a surface of non-glabrous or glabrous skin, wherein the fourth electrode is a ground electrode spaced apart a predetermined distance from the third electrode, wherein the fourth electrode is an anode; and
transcutaneously delivering a second electrical nerve stimulation to the second target nerve through the third electrode.

16. A system configured to treat a medical condition in a subject by transcutaneously delivering electrical nerve stimulation to the subject to stimulate a first target nerve, the system comprising:
a first electrode, wherein the first electrode is configured for placement on a non-glabrous skin surface, wherein the non-glabrous skin is located at a first ankle of the subject proximate a first medial malleolus, wherein the first electrode is a cathode;
a second electrode, wherein the second electrode is configured for placement on a surface of glabrous skin, wherein the second electrode is an anode; and
an electronic control system coupled to the first electrode and the second electrode, wherein the electronic control system is configured to transcutaneously deliver a first electrical nerve stimulation to the first target nerve via the first electrode and the second electrode.

17. The system of claim 16 , wherein the non-glabrous skin at least partly overlies a first flexor retinaculum.

18. The system of claim 17 , wherein the non-glabrous skin at least partly overlies a cephalic border of the first flexor retinaculum.

19. The system of claim 16 , wherein the first target nerve emanates from the sacral plexus.

20. The system of claim 13 , furthe

Assignees

• Avent Inc

Inventors

• Schepis Eric A
• Dumas Nicole Y
• Tate Martha L

Classifications

• A61N1/36031

  using physiological parameters for adjustment · CPC title

• A61N1/36034

  specified by the stimulation parameters · CPC title

• A61N1/0456 Primary

  Specially adapted for transcutaneous electrical nerve stimulation [TENS] · CPC title

• A61N1/0484

  Garment electrodes worn by the patient · CPC title

• A61N1/36014 Primary

  External stimulators, e.g. with patch electrodes (external pacemakers A61N1/3625) · CPC title