Non-invasive electrical and magnetic nerve stimulators used to treat overactive bladder and urinary incontinence

• US 10,232,174 B2
• Filed: 10/29/2015
• Issued: 03/19/2019
• Est. Priority Date: 03/20/2009
• Status: Active Grant

• Current Assignee: electroCore, Inc.
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Marlen, Tammie K
• Application Number:
  US14/927,398
• Publication Number:
  US 20160045731A1
• Time in Patent Office: 1,237 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue

Abstract

Transcutaneous electrical and magnetic nerve stimulation devices and methods of treating lower urinary tract disorders deliver energy noninvasively to nerves within a patient. The disorders comprise overactive bladder, urge incontinence, stress incontinence, urge frequency, non-obstructive urinary retention and interstitial cystitis/painful bladder syndrome. For example, a posterior tibial nerve of a patient is stimulated non-invasively. Protocol parameters are selected for a nerve stimulation session for treating each individual patient, where modules of the bladder of the patient are represented as coupled non-linear oscillators.

Claims

1. A method of treating a disorder of a lower urinary tract in a patient, the method comprising:

positioning an exterior portion of a housing in contact with an outer skin surface of the patient;

generating an electrical impulse in an interior portion of the housing; and

transmitting, as the exterior portion is in contact with the outer skin surface, the electrical impulse transcutaneously and non-invasively from the interior portion via the exterior portion to a posterior tibial nerve of the patient, wherein the electrical impulse is sufficient to cause the posterior tibial nerve to generate an action potential that at least partially relieves a symptom selected from a group of symptoms comprising at least one of urgent urination, frequency urination, urge incontinence, nocturia, ischuria, bladder discomfort, or bladder pain, wherein the electrical impulse comprises bursts of 2 pulses to 20 pulses with each of the bursts having a frequency from about 5 Hz to about 100 Hz and each of the pulses having a duration from about 50 microseconds to about 1000 microseconds.

2. The method of claim 1, wherein the electrical impulse is transmitted to the patient in a treatment session having a period of from about 3 minutes to about 3 hours followed by a period from about 3 hours to about one week where the electrical impulse is not transmitted to the patient.

3. The method of claim 1, wherein the electrical impulse is transmitted when a bladder of the patient has a bladder filling-volume that is within a predetermined range of volumes.

4. The method of claim 1, wherein the transmitting is carried out by transcutaneously passing an electric current from the exterior portion through the outer skin surface to the posterior tibial nerve.

5. The method of claim 1, further comprising:

constraining the electrical impulse from modulating a nerve in a region between the outer skin surface and the posterior tibial nerve.

6. The method of claim 1, wherein the transmitting is carried out by transmitting the electrical impulse to both a left posterior tibial nerve and a right posterior tibial nerve of the patient.

7. The method of claim 6, wherein the electrical impulse is alternately transmitted to the left posterior tibial nerve and the right posterior tibial nerve of the patient.

8. The method of claim 1, wherein the outer skin surface is located at a lower limb or foot of the patient.

9. The method of claim 1, wherein the exterior portion includes a contact surface that contacts the outer skin surface, wherein the interior portion includes a power source that generates the electrical impulse, wherein the contact surface is coupled to the power source.

10. The method of claim 1, wherein the outer skin surface is above an ankle of the patient and facing a tibia bone.

11. A method of treating a disorder of a lower urinary tract in a patient, the method comprising:

positioning an exterior portion of a housing in contact with an outer skin surface of the patient;

generating an electrical impulse in an interior portion of the housing; and

transmitting, as the exterior portion is in contact with the outer skin surface, the electrical impulse transcutaneously and non-invasively from the interior portion via the exterior portion to a selected nerve fiber within the patient, wherein the electrical impulse is sufficient to cause the selected nerve fiber to generate an action potential that at least partially relieve a symptom selected from a group of symptoms comprising urgent urination, frequency urination, urge incontinence, nocturia, ischuria, bladder discomfort, and bladder pain, wherein the electrical impulse comprises bursts of 2 pulses to 20 pulses with each of the bursts having a frequency from about 5 Hz to about 100 Hz and each of the pulses having a duration from about 50 microseconds to about 1000 microseconds.

12. The method of claim 11, wherein the electrical impulse is transmitted to the patient in a treatment session having a period from about 3 minutes to about 3 hours followed by a period from about 3 hours to about one week where the electrical impulse is not transmitted to the patient.

13. The method of claim 11, wherein the electrical impulse is transmitted when a bladder of the patient has a bladder filling-volume that is within a predetermined range of volumes.

14. The method of claim 11, wherein the transmitting is carried out by transcutaneously passing an electric current from the exterior portion through the outer skin surface of the patient to the selected nerve fiber.

15. The method of claim 11, wherein the selected nerve fiber is associated with a posterior tibial nerve of the patient.

16. The method of claim 11, wherein the selected nerve fiber is selected from among at least one of:

a tibial nerve, a pudendal nerve, a sciatic nerve, a superior gluteal nerve, a lumbo-sacral trunk nerve, an inferior gluteal nerve, a common fibular nerve, a posterior femoral cutaneous nerve, a common peroneal nerve, a plantar nerve, at least one of sacral nerves S1, S2, S3 or S4, or at least one of nerves of the S1, S2, S3 or S4 dermatome, or a sacral anterior root nerve.

17. The method of claim 11, wherein the exterior portion includes a contact surface that contacts the outer skin surface, wherein the interior portion includes a power source that generates the electrical impulse, wherein the contact surface is coupled to the power source.

18. The method of claim 11, wherein the outer skin surface is above an ankle of the patient and facing a tibia bone.

19. A method of treating a medical condition in a patient, the method comprising:

positioning an exterior portion of a housing in contact with an outer skin surface of the patient;

generating an electrical impulse in an interior portion of the housing; and

transmitting, as the exterior portion is in contact with the outer skin surface, the electrical impulse transcutaneously and non-invasively from the interior portion via the exterior portion to a posterior tibial nerve of the patient, wherein the electrical impulse is sufficient to cause the posterior tibial nerve to generate an action potential that at least partially relieves a symptom of the medical condition, wherein the electrical impulse comprises bursts of 2 pulses to 20 pulses with each of the bursts having a frequency from about 5 Hz to about 100 Hz and each of the pulses having a duration from about 50 microseconds to about 1000 microseconds.

20. The method of claim 19, wherein the transmitting is carried out by transmitting the electrical impulse to both a left posterior tibial nerve and a right posterior tibial nerve of the patient.

21. The method of claim 20, wherein the electrical impulse is alternately transmitted to the left posterior tibial nerve and the right posterior tibial nerve of the patient.

22. The method of claim 19, wherein the outer skin surface is located at a lower limb or foot of the patient.

23. The method of claim 19, wherein the exterior portion includes a contact surface that contacts the outer skin surface, wherein the interior portion includes a power source that generates the electrical impulse, wherein the contact surface is coupled to the power source.

24. The method of claim 19, wherein the outer skin surface is above an ankle of the patient and facing a tibia bone.