Systems and methods for recovery from motor control via stimulation to a substituted site to an affected area

• US 8,388,561 B2
• Filed: 09/16/2008
• Issued: 03/05/2013
• Est. Priority Date: 07/01/2005
• Status: Active Grant

• Current Assignee: United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services
• Original Assignee: United States Department Of Health And Human Services
• Inventors: Ludlow, Christy, Morgan, Newlin, Dold, George, Lowell, Soren, Dietrich-Burns, Katie
• Primary Examiner(s): Thanh, Quang D
• Application Number:
  US12/211,633
• Publication Number:
  US 20090187124A1
• Time in Patent Office: 1,631 Days
• Field of Search: 601/46, 601/48, 601/49, 601/69, 601/70, 601/71, 601/78, 601/79, 601/84, 601/87, 601/DIG.15
• US Class Current: 601/48
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61H 2039/005 by means of electromagnetic waves, e.g. I.R., U.V. rays
• CPC Class Codes: A61H 2205/04 neck
• CPC Class Codes: A61H 23/00 Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms apparatus for passive exercising A61H1/00; generating or transmitting mechanical vibrations in general B06B
• CPC Class Codes: A61H 39/00 Devices for locating or stimulating specific reflex points of the body for physical therapy, e.g. acupuncture chiropodists' instruments A61B17/54; for radiation therapy A61N5/0619
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61H 39/007 Stimulation by mechanical vibrations, e.g. ultrasonic
• CPC Class Codes: A61H 39/06 Devices for heating or cooling such points within cell-life limits cauterisers, moxaburners, cryogenic apparatus A61B18/06; heating or cooling appliances for medical treatment of general areas of the human body A61F7/00
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition

Abstract

A device and methods for treating a subject with dysphagia or other neurological disease, neurological disorder, neurological injury, neurological impairment or neurodegenerative disease that affects voluntary motor control of the hyoid, pharynx, larynx, or oropharyngeal area is disclosed. A device of the invention generally comprises a vibrotactile stimulator for applying at least one stimulus to the outside surface of a subject'"'"'s neck; a connector for attaching the vibrotactile stimulator to an outside surface of the subject'"'"'s neck, and a switch control communicatively connected to the vibrotactile stimulator to selectively engage a manual stimulation module and/or automatic stimulation module. Stimulation of an outside surface of the throat area of a subject by a device of the invention stimulates a swallowing reflex in the subject.

Claims

1. A device, comprising:

a vibrotactile stimulator configured to apply at least one stimulus to the outside surface of a subject'"'"'s neck, wherein the vibrotactile stimulator comprises;

a vibrational transducer;

a manual stimulation module configured to manually engage the vibrational transducer;

an automatic stimulation module configured to automatically engage the vibrational transducer;

a manual counter configured to determine the number of times the manual stimulation module is engaged; and

an automatic counter configured to determine the number of times the automatic stimulation module is engaged;

a connector configured to attach the vibrotactile stimulator to an outside surface of the subject'"'"'s neck; and

a switch control communicatively connected to the vibrotactile stimulator and configured to selectively engage the manual stimulation module or the automatic stimulation module.

2. The device of claim 1, wherein the connector comprises an adjustment mechanism configured to position a contact section substantially over the subject'"'"'s larynx.

3. The device of claim 2, wherein the adjustment mechanism is configured to shift the position of the contact section within a circle having an area of about 0.1 to about 10 cm², about 0.25 to about 5 cm², or about 0.5 to about 2.5 cm².

4. The device of claim 1, wherein the vibrational transducer is a vibrator motor.

5. The device of claim 1, wherein the automatic stimulation module comprises an automatic timer.

6. The device of claim 1, wherein the manual counter and the automatic counter are configured to be manually interrogated and reset.

7. The device of claim 1, wherein the manual counter and the automatic counter are configured to be remotely interrogated and reset.

8. The device of claim 1, wherein the at least one stimulus comprises a sequential wave of pressure.

9. The device of claim 1, wherein the vibrational transducer produces a wave having an amplitude of about 1 micron to about 2 mm or about 100 microns to about 1 mm.

10. The device of claim 1, wherein the vibrational transducer produces a wave having a frequency of about 50 Hz to about 70 Hz.

11. The device of claim 10, wherein the vibrational transducer produces a wave having a frequency of about 59 Hz.

12. The device of claim 1, wherein the vibrational transducer produces a wave having a rise time of about 25 ms to about 500 ms or about 75 ms to about 150 ms.

13. The device of claim 1, wherein the at least one stimulus comprises a vibrational stimulus, an auditory stimulus, a temperature stimulus, a visual stimulus, an olfactory stimulus, a gustatory stimulus, or a combination thereof.

14. The device of claim 1, wherein the at least one stimulus comprises vibratory and pressure stimuli applied to the outside surface of the subject'"'"'s neck.

15. The device of claim 1, further comprising:

one or more physiological sensors electrically coupled to the vibrotactile stimulator;

a swallowing receptor comprising a piezoelectric sensor;

a battery, contained within the vibrotactile stimulator, acting as a power supply for the device; and

a control box configured to select one or more of the stimulus mode, stimulus type, stimulus rate, and stimulus amplitude.

16. The device of claim 1, wherein the vibrotactile stimulator comprises at least one motor or pump.

17. The device of claim 15, wherein the one or more physiological sensors are selected from the group consisting of movement sensors, temperature sensors, skin color sensors, hematocrit sensors, oxygenation sensors, and blood pressure sensors.

18. The device of claim 15, wherein the piezoelectric sensor is configured to be positioned on the outside surface of the subject'"'"'s skin substantially above the larynx.

19. The device of claim 1, wherein the vibrotactile stimulator comprises:

a digital clock generator configured to produce an initial clock signal having a first frequency range;

a digital decade counter configured to receive the initial clock signal and producing sequential pulses having a second frequency range; and

a motor responsive to the sequential pulses configured to produce vibrations on the subject'"'"'s larynx, having a third frequency range.

20. The device of claim 19, wherein the initial clock signal is adjustable and comprises a frequency of about one signal every 3 minutes to about one signal every 30 minutes.

21. The device of claim 19, wherein the second frequency range for pulse stimulation is about 1 Hz to about 10 Hz, about 20 Hz to about 75 Hz, or about 30 Hz to about 60 Hz.

22. The device of claim 19, wherein the third frequency range is about 15 Hz to about 200 Hz or about 20 Hz to about 100 Hz.

23. The device of claim 19, wherein the motor comprises a planetary gearbox.

24. The device of claim 19, wherein the motor produces vibrations at a frequency of about 59 Hz.

25. The device of claim 1, wherein the vibrotactile stimulator is configured to apply pressure of about 1 psi to about 14 psi to the subject'"'"'s neck.

26. The device of claim 5, wherein the automatic timer comprises:

an automatic clock to initiate onset of the automatic stimulation module;

an adjustable clock to initiate pulsed stimulation at an adjustable interval of about 0.5 s to about 30 minutes; and

an adjustable timer configured to set a duration of pulsed stimulation of about 0.1 s to about 500 ms.

27. A method for inducing a swallowing reflex in a subject to prevent drooling and/or aspiration of the subject'"'"'s own secretions, comprising:

applying the device to the outside surface of the subject'"'"'s neck substantially over the subject'"'"'s larynx, the device comprising;

a vibrotactile stimulator configured to apply at least one stimulus to the outside surface of a subject'"'"'s neck, wherein the vibrotactile stimulator comprises;

a vibrational transducer;

a manual stimulation module configured to manually engage vibrational transducer;

an automatic stimulation module configured to automatically engage the vibrational transducer;

a manual counter configured to determine the number of times the manual stimulation module is engaged; and

an automatic counter configured to determine the number of times the automatic stimulation module is engaged;

a connector configured to attach the vibrotactile stimulator to an outside surface of the subject'"'"'s neck; and

a switch control communicatively connected to the vibrotactile stimulator and configured to selectively engage the manual stimulation module or the automatic stimulation module; and

configuring an automatic timer to activate the vibrotactile stimulator about once every 3 minutes to about once every 30 minutes for a duration of about 10 ms to about 20 during which pulsed stimulation is produced at vibrations of about 1 Hz to 300 Hz lasting about 200 ms to about 10 s to induce the swallowing reflex, wherein activating the vibrotactile stimulator includes pulsing the vibrotactile stimulator at a particular rate and for a particular interval to produce the vibrations and applying pressure at about 1 psi to about 14 psi to the subject'"'"'s neck during an onset period.

28. The method of claim 27, wherein the onset period comprises about 10 ms to about 1.5 s, about 50 ms to about 750 ms, or about 100 ms to about 500 ms.

29. The method of claim 27, wherein the automatic timer is configured to activate the vibrotactile stimulator at an interval of about 1 minute to about 30 minutes.

30. The method of claim 27, wherein the vibrations are at a frequency of about 40 Hz to about 70 Hz.

31. A method for identifying a subject at risk of aspiration from their own secretions, comprising:

applying a device to an outside surface of the subject'"'"'s neck substantially over the subject'"'"'s larynx, the device comprising;

a vibrotactile stimulator configured to apply at least one stimulus to the outside surface of a subject'"'"'s neck, wherein the vibrotactile stimulator comprises;

a vibrational transducer;

a manual stimulation module configured to manually ngaage the vibrational transducer;

an automatic stimulation module configured to automatically engage the vibrational transducer;

a manual counter configured to determine the number of times the manual stimulation module is engaged; and

an automatic counter configured to determine the number of times the automatic stimulation module is engaged;

a connector configured to attach the vibrotactile stimulator to an outside surface of the subject'"'"'s neck;

a switch control communicatively connected to the vibrotactile stimulator and configured to selectively engage the manual stimulation module or the automatic stimulation module; and

an actuator, wherein the subject activated the device with the actuator to induce swallowing;

downloading data from the vibrotactile stimulator after a period of use of the device by the subject; and

analyzing the data to determine if the subject is at risk of aspiration from their own secretions.

32. The method of claim 31, wherein the secretions are saliva.

33. The method of claim 31, wherein the actuator comprises a button.

34. A method for monitoring subject compliance with a training or therapy regime, comprising:

applying a device to an outside surface of the subject'"'"'s neck substantially over the subject'"'"'s larynx, the device comprising;

a vibrotactile stimulator configured to apply at least one stimulus to the outside surface of a subject'"'"'s neck, wherein the vibrotactile stimulator comprises;

a vibrational transducer;

a manual stimulation module configured to manually engage the vibrational transducer;

an automatic stimulation module configured to automatically engage the vibrational transducer;

a manual counter configured to determine the number of times the manual stimulation module is engaged; and

an automatic counter configured to determine the number of times the automatic stimulation module is engaged;

a connector configured to attach the vibrotactile stimulator to an outside surface of the subject'"'"'s neck;

a switch control communicatively connected to the vibrotactile stimulator and configured to selectively engage the manual stimulation module or the automatic stimulation module; and

an actuator, wherein the subject activated the device with the actuator to induce swallowing;

downloading data from the vibrotactile stimulator after a period of use of the device by the subject; and

analyzing the data to determine the subject'"'"'s compliance with the training or therapy regime.

35. The method of claim 34, wherein the subject manually activated or automatically activated the device with the actuator.

36. The method of claim 34, wherein the actuator comprises a button.