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

• US 9,174,045 B2
• Filed: 10/24/2011
• Issued: 11/03/2015
• Est. Priority Date: 03/20/2009
• Status: Expired due to Fees

• Current Assignee: Electrocore, Llc
• Original Assignee: Electrocore, Llc
• Inventors: Simon, Bruce J., Errico, Joseph P., Raffle, John T.
• Primary Examiner(s): Heller, Tammie K
• Application Number:
  US13/279,437
• Publication Number:
  US 20120101326A1
• Time in Patent Office: 1,471 Days
• Field of Search: 607/40, 607/41, 607/133, 607/143, 607/145
• US Class Current: 1/1
• 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 generate energy that is delivered noninvasively to selected nerve fibers within the patient to treat lower urinary tract disorders. The disorders comprise overactive bladder, urge incontinence, stress, incontinence, urge frequency, non-obstructive urinary retention and interstitial cystitis/painful bladder syndrome. In preferred embodiments, a posterior tibial nerve of a patient is stimulated non-invasively to treat bladder disorders.

Claims

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

positioning a device adjacent to a skin surface of the patient;

generating one or more electrical impulses with the device; and

transmitting the one or more electrical impulses from the device to selected nerve fibers in the patient;

wherein the one or more electrical impulses is sufficient to cause the selected nerve fibers to generate action potentials that at least partially relieve a symptom selected from a group of symptoms comprising urgent urination, frequent urination, urge incontinence, urgent urination with incontinence, frequent urination with incontinence, nocturia, ischuria, bladder discomfort, and bladder pain, and

wherein the one or more electrical impulses is transmitted to the patient in a treatment session having a period from about 3 minutes to about three hours, followed by a period from about three hours to about one week wherein the one or more electrical impulses is not transmitted to the patient, and

wherein the one or more electrical impulses is transmitted when the bladder of the patient has a bladder filling-volume that is within a predetermined range of volumes,

wherein the one or more electrical impulses is transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers,

wherein the transmitting is carried out by generating a magnetic field via the device, wherein the magnetic field is exterior to the patient, wherein the magnetic field is sufficient to induce the one or more electrical impulses at or near the selected nerve fibers within the patient.

2. The method of claim 1, wherein an energy source within the device is configured to generate shaped electrical impulses and transmit the shaped electrical impulses to the patient through a conducting medium within the device.

3. The method of claim 1, wherein the transmitting is carried out by transcutaneously passing an electrical current through the outer skin surface of the patient to a target region within the patient.

4. The method of claim 3, further comprising:

generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve at the target region; and

wherein the electric field is not sufficient to modulate a nerve or a muscle between the outer skin surface and the target region.

5. The method of claim 4, wherein the electric field is not sufficient to produce movement of a skeletal muscle in a limb of the patient.

6. The method of claim 1, wherein at least one of the nerve fibers is at least from about 0.5 cm to about 2 cm below the outer skin surface of the patient.

7. The method of claim 1, wherein the one or more electrical impulses is constrained from modulating one or more nerves in a region between the skin surface and at least one of the selected nerve fibers.

8. The method of claim 1, wherein the selected nerve fibers are associated with a posterior tibial nerve of the patient.

9. The method of claim 1, wherein the selected nerve fibers are associated with both left and right posterior tibial nerves of the patient.

10. The method of claim 9, wherein the one or more electrical impulses is transmitted alternately to the left and right posterior nerves of the patient.

11. The method of claim 1, wherein at least one of the nerve fibers is selected from among:

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

12. The method of claim 1, wherein the one or more electrical impulses comprise bursts of pulses with a frequency from about 5 bursts per second (Hz) to about 100 bursts per second (Hz).

13. The method of claim 12, wherein each of the bursts contains from about 1 pulse to about 20 pulses.

14. The method of claim 12 wherein the pulses are full sinusoidal waves.

15. The method of claim 12, wherein each of the pulses is from about 50 microseconds to about 1000 microseconds in duration.

16. The method of claim 1, wherein a first power of the one or more electrical impulses is configured to be a predetermined percentage of a second power needed to first produce movement of a skeletal muscle in a limb of the patient.

17. The method of claim 1, wherein the one or more electrical impulses is transmitted preferentially when the patient'"'"'s bladder-filling is in a phase selected from among:

a refractory phase following urination wherein the patient has no desire to urinate;

a phase beginning with a first desire to urinate and ending before a strong desire to urinate; and

a phase beginning with a strong desire to urinate that cannot be ignored by the patient.

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

positioning a device adjacent to a skin surface of the patient;

generating one or more electrical impulses with the device; and

transmitting the one or more electrical impulses from the device to selected nerve fibers in the patient;

wherein the one or more electrical impulses is sufficient to cause the selected nerve fibers to generate action potentials that at least partially relieve a symptom selected from a group of symptoms comprising urgent urination, frequent urination, urge incontinence, urgent urination with incontinence, frequent urination with incontinence, nocturia, ischuria, bladder discomfort, and bladder pain, and

wherein the one or more electrical impulses is transmitted to the patient in a treatment session having a period from about 3 minutes to about three hours, followed by a period from about three hours to about one week wherein the one or more electrical impulses is not transmitted to the patient, and

wherein the one or more electrical impulses is transmitted when the bladder of the patient has a bladder filling-volume that is within a predetermined range of volumes,

wherein one or more protocol parameters for a treatment session is selected individually for the patient, wherein the one or more protocol parameters comprising at least one of;

a burst frequency, a number of pulses per burst, a duration of a pulse within a burst, a power of electrical impulses, a duration of an impulse-transmission session, a duration of a period during which impulses are not transmitted, a phase or phases of bladder-filling of a patient when electrical impulses are transmitted, and a range of bladder filling-volumes when electrical impulses are transmitted,

wherein the one or more protocol parameters is selected via;

performing measurements of bladder and urethra function of the patient;

using said measurements to estimate values of numerical parameters in a set of differential equations that represents modules of the bladder of the patient as coupled non-linear oscillators;

simulating a plurality of potential treatments by solving said differential equations with different protocol parameters; and

selecting among said simulations the one having protocol parameters that minimize simulated bladder contractions.

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

positioning a device adjacent to a skin surface of the patient;

generating one or more electrical impulses with the device; and

transmitting the one or more electrical impulses from the device to selected nerve fibers in the patient, wherein the one or more electrical impulses is sufficient to cause the selected nerve fibers to generate action potentials that at least partially relieve a symptom selected from a group of symptoms comprising urgent urination, frequent urination, urge incontinence, urgent urination with incontinence, frequent urination with incontinence, nocturia, ischuria, bladder discomfort, and bladder pain, and wherein the one or more electrical impulses is transmitted to the patient in a treatment session having a period from about 3 minutes to about three hours, followed by a period from about three hours to about one week wherein the one or more electrical impulses is not transmitted to the patient, and wherein one or more protocol parameters for a treatment session is selected individually for the patient, wherein the one or more protocol parameters comprising at least one of;

a burst frequency, a number of pulses per burst, a duration of a pulse within a burst, a power of electrical impulses, a duration of an impulse-transmission session, a duration of a period during which impulses are not transmitted, a phase or phases of bladder-filling of a patient when electrical impulses are transmitted, and a range of bladder filling-volumes when electrical impulses are transmitted, and wherein the one or more protocol parameters is selected via;

performing measurements of bladder and urethra function of the patient;

using said measurements to estimate values of numerical parameters in a set of differential equations that represents modules of the bladder of the patient as coupled non-linear oscillators;

simulating a plurality of potential treatments by solving said differential equations with different protocol parameters; and

selecting among said simulations the one having protocol parameters that minimize simulated bladder contractions.

20. The method of claim 19, wherein an energy source within the device is configured to generate shaped electrical impulses and transmit the shaped electrical impulses to the patient through a conducting medium within the device.

21. The method of claim 19, wherein the one or more electrical impulses is transmitted transcutaneously through an outer skin surface of the patient to generate an electrical impulse at or near the selected nerve fibers.

22. The method of claim 21, wherein the transmitting is carried out by transcutaneously passing an electrical current through the outer skin surface of the patient to a target region within the patient.

23. The method of claim 22, further comprising:

generating an electrical field at or near the device and shaping the electrical field such that the electrical field is sufficient to modulate a nerve at the target region; and

wherein the electric field is not sufficient to modulate a nerve or a muscle between the outer skin surface and the target region.

24. The method of claim 23, wherein the electric field is not sufficient to produce movement of a skeletal muscle in a limb of the patient.

25. The method of claim 21, wherein the transmitting is carried out by generating a magnetic field via the device, wherein the magnetic field is exterior to the patient, wherein the magnetic field is sufficient to induce the one or more electrical impulses at or near the selected nerve fibers within the patient.

26. The method of claim 21, wherein at least one of the nerve fibers is at least from about 0.5 cm to about 2 cm below the outer skin surface of the patient.

27. The method of claim 19, wherein the one or more electrical impulse is constrained from modulating one or more nerves in a region between the skin surface and at least one of the selected nerve fibers.

28. The method of claim 19, wherein the selected nerve fibers are associated with a posterior tibial nerve of the patient.

29. The method of claim 19, wherein the selected nerve fibers are associated with both left and right posterior tibial nerves of the patient.

30. The method of claim 29, wherein the one or more electrical impulses is transmitted alternately to the left and right posterior nerves of the patient.

31. The method of claim 19, wherein at least one of the nerve fibers is selected from among:

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

32. The method of claim 19, wherein the one or more electrical impulses comprise bursts of pulses with a frequency from about 5 bursts per second (Hz) to about 100 bursts per second (Hz).

33. The method of claim 32, wherein each of the bursts contains from about 1 pulse to about 20 pulses.

34. The method of claim 32, wherein the pulses are full sinusoidal waves.

35. The method of claim 32, wherein each of the pulses is from about 50 microseconds to about 1000 microseconds in duration.

36. The method of claim 19, wherein a first power of the one or more electrical impulses is configured to be a predetermined percentage of a second power needed to first produce movement of a skeletal muscle in a limb of the patient.

37. The method of claim 19, wherein the one or more electrical impulses is transmitted preferentially when the patient'"'"'s bladder-filling is in a phase selected from among:

a refractory phase following urination wherein the patient has no desire to urinate;

a phase beginning with a first desire to urinate and ending before a strong desire to urinate; and

a phase beginning with a strong desire to urinate that cannot be ignored by the patient.