NON-INVASIVE MODULATION OF THE AUTONOMIC NERVOUS SYSTEM

• US 20080004679A1
• Filed: 07/18/2007
• Published: 01/03/2008
• Est. Priority Date: 06/23/2005
• Status: Abandoned Application

• Current Assignee: ThermaRx Co.
• Original Assignee: ThermaRx Co.
• Inventors: Naghavi, Mortaza, Naghavi, Mojtaba, O'Brien, Timothy, Johnson, Mark, Naghavi, Morteza
• Application Number:
  US11/779,543
• Publication Number:
  US 20080004679A1
• Time in Patent Office: Days
• US Class Current: 607/108
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61F 7/007 characterised by electric heating
• CPC Class Codes: A61N 2/002 in combination with another treatment
• CPC Class Codes: A61N 2/006 for magnetic stimulation of nerve tissue
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

The present invention is directed to methods and apparatus for modulation of the sympathetic-parasympathetic balance by application of heat, carotid and/or ocular message to reduce sympathetic tone or increase parasympathetic tone in a target muscle system to relieve a symptom of urinary hesitancy, shy bladder syndrome, DESD, urinary retention, or laryngeal spasm, as well as to monitor the efficacy of treatments for bladder conditions and to assist in the passage of medical devices through bodily sphincters as well as to treat congestive heart failure.

Claims

1. An apparatus for control of bladder function comprising a controlled heating device that facilitates voiding of the bladder when desired.

2. The apparatus of claim 1, wherein the heating is applied prior to voiding to reduce sympathetic activity and prepare the bladder for voiding.

3. The apparatus of claim 1, wherein the device is wearable.

4. The apparatus of claim 1, wherein the device is worn in association with, or disposed in, underwear.

5. The apparatus of claim 1, wherein the device comprises a pair of heating pocket inserts.

6. The apparatus of claim 5, wherein the heating pocket inserts are dimensioned to enclose a hand.

7. The apparatus of claim 1 wherein the heat is provided by diathermy directed to the bladder area.

8. The apparatus of claim 1, wherein the heating device generates heat by chemical reaction or is heated by microwave action.

9. The apparatus claim 1, wherein the heat is provided in treatment of lower urinary tract symptoms such as urinary hesitancy, nocturia, and shy bladder conditions.

10. An apparatus for control of bladder function, comprising:

at least one heating element disposed in a wearable appliance that applies heat to a body region distal to the bladder when voiding of the bladder is desired.

11. The apparatus of claim 10, wherein the region is one or more of:

a portion of the head, hands, feet and thighs.

12. The apparatus of claim 10, wherein the appliance is disposed in, or in association with, one or more garments selected from the group consisting of:

gloves, socks, shoes, helmets, caps, head bands, wrist bands, scarves, jackets, vests, and abdominal wraps.

13. The apparatus of claim 10, comprising a plurality of heating elements including at least heating elements that apply heat to at least the hands, feet and lower abdominal regions simultaneously.

14. The apparatus of claim 10, wherein the appliance comprises a pair of heating thigh bands.

15. The apparatus of claim 14, further comprising a heating hand pocket dimensioned to be worn around the waist.

16. The apparatus of claim 10, wherein the heating element generates heat by chemical reaction or is heated by microwave action.

17. An apparatus for control of bladder function in an individual, comprising:

a heat source disposed in a non-wearable fixed or portable appliance that controllably delivers heat to the individual when voiding of the bladder is desired.

18. The apparatus of claim 17, wherein the appliance delivers conductive heat, radiant heat, warm air, and/or a warm hand hold.

19. The apparatus of claim 17, wherein the heat source is a heating bag that is dimensioned to conform to a shape of the upper thigh surface.

20. The apparatus of claim 17, wherein the heating bag is U-shaped.

21. The apparatus of claims 19 or 20, wherein the heating bag further comprises a heating belly flap.

22. The apparatus of any one of claims 19-21, further comprising a thermometer, such as a liquid crystal thermometer, affixed to the heating bag.

23. The apparatus claim 17, wherein the heat is provided in treatment of one or more of urinary hesitancy, shy bladder and nocturia conditions.

24. A fixture for controllably applying heat locally, regionally and/or distally relative to a bladder area of an individual, the fixture comprising:

at least one heating element located as part of a toilet system, whereby the heating element delivers heat sufficient to facilitate voiding of the bladder.

25. The fixture of claim 24, wherein at least one heating element is a heating wrap dimensioned to provide heat to a lower abdominal region.

26. The fixture of claim 24, wherein at least one heating element is a heating blanket dimensioned to provide heat to the upper thighs.

27. The fixture of claim 24, wherein at least one heating element is a pair of thigh wraps dimensioned to provide heat to the upper thighs.

28. The fixture of claim 24, wherein at least one heating element is a heating toilet set lid.

29. The fixture of claim 29, wherein at least one heating element is a pair of slippers dimensioned to provide heat to the feet.

30. A balloon catheter comprising a balloon dimensioned to receive an inflation fluid that includes or activates one or more chemicals or reactive compounds that generate heat from the inflated balloon.

31. An intra-vaginal probe that comprises a heating element.

32. The intra-vaginal probe of claim 31, wherein the heating element generates heat by chemical reaction or comprises a compound that is activated by microwave radiation to emit heat.

33. A method for control of bladder function in treatment of urinary hesitancy, shy bladder and nocturia conditions in a patient, comprising:

supplying at least one heating appliance that is dimensioned to apply local heat to at least one area of the patient to facilitate voiding of the bladder when desired.

34. The method of claim 33, wherein the area is selected from the group consisting of the lower abdomen, lower back, perineum, upper thighs, feet, hands, and combinations thereof.

35. The method of claim 34, wherein the appliance comprises a pair of heating thigh bands.

36. The method of claim 34, wherein the appliance comprises a pair of heating hand pockets or pocket inserts.

37. The method of claim 34, wherein the appliance is worn in association with, or disposed in, underwear.

38. The method of claim 33 wherein the heating appliance includes a controller that is operable by the patient for turning on and off of the heating element.

39. The method of claim 33, wherein the area is one or more of:

face, fingers, and toes.

40. The method of claim 33, wherein the appliance is disposed in, or in association with, one or more of:

gloves, socks, shoes, helmets, caps, head and/or ear bands, ear patches, ear lobe clips, nail covers, wrist bands, scarves, jackets, vests, and abdominal wraps.

41. A method for control of bladder function in an individual, comprising:

turning on a heat source disposed in non-wearable fixed or portable appliance that delivers heat locally and/or distally to the individual when voiding of the bladder is desired; and

turning off the heat source when voiding of the bladder is completed.

42. The method of claim 41, wherein the appliance delivers radiant heat, warm air, or a warm hand hold.

43. The method of claim 41, wherein the heat source generates heat by its effect in tissue by diathermy.

44. The method claim 41, wherein the heat is provided in treatment of one or more of urinary hesitancy, shy bladder and nocturia conditions.

45. A method for quantitative self evaluation of efficacy of a treatment for urinary hesitancy comprising:

determining a baseline urinary output flow by measuring urination volume over urination time;

initiating treatment; and

determining a series of treatment urinary output flow by urination volume over urination time measurements; and

evaluating the treatment objectively based on improvements in urination volume over urination time.

46. A kit for quantitative self evaluation of efficacy of a treatment for urinary hesitancy comprising:

a graduated container for measuring urination volume; and

a timing device having a start button and a stop button and a display of elapsed time, and a log for recording urination volume over urination time.

47. The kit of claim 46, wherein the container comprises a handle for conveniently holding the container in position.

48. The kit of claim 47, wherein the timing device is mounted on the handle.

49. The kit of claim 47, wherein the container is disposable and the handle is removable from the container for reuse.

50. A method for shifting a sympathetic-parasympathetic balance to treat of heart failure, comprising applying sufficient heat provided by a wearable appliance or garment that includes an on-off controller to intermittently deliver sufficient heat to result in peripheral resistance.

51. The method of claim 50, wherein the garment is selected from the group consisting of:

underwear, gloves, socks, shoes, helmets, scarves, jackets and vests.

52. A method for shifting a sympathetic-parasympathetic balance to dilate a sphincter to facilitate passage or placement of a medical device comprising;

applying heat sufficient to induce dilation of the sphincter; and

inserting the device through the dilated sphincter or placing the medical device in the sphincter.

53. The method of claim 52, wherein the heat is applied regionally.

54. The method of claim 53, wherein at least a portion of the medical device is heated.

55. The method of claim 52, wherein the heated medical device is dimensioned for passage through, or placement in, the bladder neck.