Devices and methods for treating restless leg syndrome

• US 9,017,273 B2
• Filed: 03/02/2009
• Issued: 04/28/2015
• Est. Priority Date: 02/29/2008
• Status: Active Grant

• Current Assignee: Sensory Neurostimulation, Inc.
• Original Assignee: Sensory Neurostimulation, Inc.
• Inventors: Burbank, Fred, Jones, Mike, Memmolo, Al
• Primary Examiner(s): Yu, Justine
• Assistant Examiner(s): Louis, Latoya M
• Application Number:
  US12/396,358
• Publication Number:
  US 20090221943A1
• Time in Patent Office: 2,248 Days
• Field of Search: 601/33, 601/34, 601 46- 49, 601 56- 58, 601/66, 601/67, 601/70, 601/71, 601/78, 601/79, 601/84, 601/107
• US Class Current: 601/46
• CPC Class Codes: A61F 2007/0071 using a resistor, e.g. near the spot to be heated
• CPC Class Codes: A61F 2007/0075 using a Peltier element, e.g. near the spot to be heated or cooled
• CPC Class Codes: A61F 2007/0296 Intervals of heating alternated with intervals of cooling
• CPC Class Codes: A61H 1/008 Apparatus for applying pressure or blows almost perpendicular to the body or limb axis, e.g. chiropractic devices for repositioning vertebrae, correcting deformation
• CPC Class Codes: A61H 1/0237 for the lower limbs
• CPC Class Codes: A61H 1/0255 Both knee and hip of a patient, e.g. in supine or sitting position, the feet being moved together in a plane substantially parallel to the body-symmetrical plane A61H1/0214 takes precedence
• CPC Class Codes: A61H 1/0266 Foot
• CPC Class Codes: A61H 15/0078 power-driven
• CPC Class Codes: A61H 2015/0014 cylinder-like, i.e. rollers
• CPC Class Codes: A61H 2201/0142 Beds
• CPC Class Codes: A61H 2201/02 heated or cooled
• CPC Class Codes: A61H 2201/0228 heated by an electric resistance element
• CPC Class Codes: A61H 2201/0242 by a fluid circulating in the apparatus
• CPC Class Codes: A61H 2201/0257 by a heat accumulator, e.g. a sand or liquid reservoir
• CPC Class Codes: A61H 2201/0285 with Peltier elements
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2201/1207 with electric or magnetic drive
• CPC Class Codes: A61H 2201/1215 Rotary drive
• CPC Class Codes: A61H 2201/1642 Holding means therefor
• CPC Class Codes: A61H 2201/165 : Wearable interfaces
• CPC Class Codes: A61H 2201/1676 : Pivoting
• CPC Class Codes: A61H 2201/5005 : for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2203/0456 : Supine
• CPC Class Codes: A61H 2205/10 : Leg
• CPC Class Codes: A61H 2205/106 : for the lower legs
• CPC Class Codes: A61H 2205/108 : for the upper legs
• CPC Class Codes: A61H 2205/12 : Feet
• CPC Class Codes: A61H 23/02 : with electric or magnetic drive
• CPC Class Codes: A61H 23/0218 : with alternating magnetic fields producing a translating or oscillating movement
• CPC Class Codes: A61H 23/0263 : using rotating unbalanced masses
• CPC Class Codes: A61H 7/001 : without substantial movement between the skin and the device
• CPC Class Codes: A61H 7/004 : power-driven, e.g. electrical
• CPC Class Codes: A61H 9/0078 : with intermittent or alternately inflated bladders or cuffs mattresses for preventing bed-sores with alternated pressurized chambers A61G7/05776
• CPC Class Codes: A61H 9/0092 : Cuffs therefor
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 2/00 : Magnetotherapy

Abstract

An exemplary system for generating a counter-stimulation in a patient suffering from RLS includes a device configured and arranged to generate a counter-stimulation in a patient suffering from RLS, the counter-stimulation of an amplitude, intensity, and time duration lower than that which would wake the patient and higher than that sufficient to relieve RLS, or sufficient to relieve RLS symptoms and allow the patient to return to sleep, a controller configured and arranged to drive the counter-stimulation generation device, the controller being in communication with the counter-stimulation device, and a base configured and arranged to hold the counter-stimulation generation device adjacent to a patient, the counter-stimulation device attached to the base. An exemplary method of treating RLS includes selecting a patient experiencing RLS, and stimulating a portion of the patient at an amplitude, intensity, and duration sufficient to act as a counter-stimulation to RLS.

Claims

1. A system for generating a counter-stimulation in a patient suffering from restless leg syndrome, the system comprising:

a vibration generator configured and arranged to generate a counter-stimulation vibration in a patient suffering from restless leg syndrome, the counter-stimulation having a frequency of between 50 hz and 10 per minute and of an amplitude and time duration either lower than that which would wake the patient and higher than that sufficient to relieve restless leg syndrome symptoms, or sufficient to relieve restless leg syndrome symptoms and allow the patient to return to sleep;

a controller configured and arranged to drive the vibration generator, the controller in communication with the vibration generator, the controller being configured and arranged to ramp down the counter-stimulation so as not to waken or alarm the patient; and

a base configured and arranged to hold the vibration generator adjacent to a patient, the vibration generator attached to the base.

2. The system according to claim 1, wherein the vibration generator comprises a device selected from the group consisting of a piezo-chip, a loudspeaker, a motor with an eccentric weight, and a solenoid.

3. The system according to claim 2, wherein the vibration generator comprises an electric motor having a shaft, and a weight having a hole therein, the weight positioned on the shaft, the hole located at a position offset from a center of mass of the weight.

4. The system according to claim 3, further comprising:

a housing attached to the base; and

wherein the weight is located in the housing.

5. The system according to claim 1, wherein the base comprises a flexible sheet.

6. The system according to claim 5, wherein the sheet comprises a foam sheet, the vibration generator positioned in the foam sheet.

7. The system according to claim 1, wherein the base comprises a rigid shell having at least one housing, the vibration generator located in the housing.

8. The system according to claim 7, wherein the vibration generator comprises a mechanical vibrator.

9. The system according to claim 7, wherein the rigid shell comprises a hole sized and adapted to receive the kneecap of the patient.

10. The system according to claim 7, wherein the rigid shell is shaped to at least in part conformingly fit over the thigh of the patient.

11. The system according to claim 7, wherein the rigid shell is shaped to conformingly fit over the calf of the patient.

12. The system according to claim 1, wherein the base comprises a flexible and elastic sleeve having at least one pocket, the vibration generator positioned in the at least one pocket.

13. The system according to claim 1, further comprising:

a plurality of vibration generators attached to the base and in communication with the controller.

14. A method of treating restless leg syndrome, the method comprising:

selecting a patient experiencing restless leg syndrome;

vibrating a portion of the patient with a vibration generator at a frequency of between 50 hz and 10 per minute during a restless leg syndrome episode at an amplitude and duration sufficient to act as a counter-stimulation vibration to said restless leg syndrome episode and either to allow the patient to return to sleep or to not wake a sleeping patient; and

ramping down the counter-stimulation vibration so as not to waken or alarm the patient.

15. The method according to claim 14, wherein said patient is asleep;

and wherein said vibrating is insufficient to wake the patient.

16. The method according to claim 14, wherein the patient is awake;

and wherein said vibrating is insufficient to prevent the patient from falling asleep.

17. The method according to claim 14, wherein said vibrating comprises vibrating with an electric motor.

18. A method of treating restless leg syndrome, the method comprising:

selecting a patient experiencing restless leg syndrome;

vibrating a portion of the patient with a vibration generator at a frequency of between 50 hz and 10 per minute during a restless leg syndrome episode at an amplitude and duration sufficient to act as a counter-stimulation vibration to said restless leg syndrome episode and either to allow the patient to return to sleep or to not wake a sleeping patient; and

initiating said vibrating step at the onset of an episode of restless leg syndrome symptoms; and

ramping down the counter-stimulation vibration so as not to awaken or alarm the patient.

19. The method according to claim 18, wherein counter-stimulating vibration is initiated while the patient is awake;

and wherein said vibrating is insufficient to prevent the patient from falling asleep.

20. A method of treating restless leg syndrome, the method comprising:

selecting a patient experiencing restless leg syndrome;

vibrating a portion of the patient with a vibration generator at a frequency of between 50 hz and 10 per minute at an amplitude, and duration sufficient to act as a counter-stimulation vibration to restless leg syndrome but low enough to allow the patient to sleep; and

initiating said stimulating step at the onset of an episode of restless leg syndrome symptoms; and

ramping down the counter-stimulation vibration so as not to awaken the patient.

21. The method according to claim 20, wherein counter-stimulating vibration is initiated while the patient is awake;

and wherein said vibrating is insufficient to prevent the patient from falling asleep.

22. A method of treating restless leg syndrome, the method comprising:

selecting a patient experiencing restless leg syndrome;

vibrating a portion of the patient with a vibration generator at a frequency of between 50 hz and 10 per minute at an amplitude and duration sufficient to act as a counter-stimulation vibration to restless leg syndrome but low enough to allow the patient to sleep; and

performing said stimulating step while (1) the patient is attempting to sleep and (2) while the patient is experiencing symptoms of restless leg symptoms; and

ramping down the counter-stimulation vibration so as not to awaken the patient.

23. The method according to claim 22, wherein counter-stimulating vibration is initiated while the patient is awake;

and wherein said vibrating is insufficient to prevent the patient from falling asleep.

24. A method of treating restless leg syndrome, the method comprising:

selecting a patient experiencing restless leg syndrome;

applying a counter-stimulation generation device to a leg of the patient, said counter-stimulation generation device comprising a vibration generator, a controller operable to drive the counter-stimulation generation device, and a sleeve or pad for holding the vibration generator, said vibration generator operable to generate a counter-stimulation having a frequency of between 50 hz and 10 per minute of an amplitude, and time duration sufficient to relieve restless leg syndrome symptoms but low enough to allow the patient to sleep;

operating the counter-stimulation generation device to provide counter-stimulating vibration to the legs of the patient, at the onset of a restless leg syndrome episode;

ramping down the counter-stimulation vibration after a period of 5 to 30 minutes of counter-stimulation vibrations.

25. The method according to claim 24, wherein counter-stimulating vibration is initiated while the patient is awake;

and wherein said vibrating is insufficient to prevent the patient from falling asleep.