Enhanced therapeutic stimulus system and methods of use

• US 8,939,919 B2
• Filed: 04/26/2012
• Issued: 01/27/2015
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Innara Health, Inc., University of Kansas
• Original Assignee: Innara Health, Inc., University of Kansas
• Inventors: Barlow, Steven M., Aron, Kenneth, Stalling, David L.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US13/457,059
• Publication Number:
  US 20130289648A1
• Time in Patent Office: 1,006 Days
• Field of Search: 607/42, 607/45, 607/2, 607/134, 607/48
• US Class Current: 600/590
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/038 Measuring oral pressure
• CPC Class Codes: A61B 5/4064 Evaluating the brain A61B5/031, A61B5/369, A61B5/14553 take precedence
• CPC Class Codes: A61B 5/6896 Toys
• CPC Class Codes: A61H 9/0007 Pulsating
• CPC Class Codes: A61J 17/001 Baby-comforters
• CPC Class Codes: A61N 1/3606 adapted for a particular treatment
• CPC Class Codes: A61N 1/36067 Movement disorders, e.g. tremor or Parkinson disease stimulating motor muscle A61N1/36003
• CPC Class Codes: A61N 1/36103 Neuro-rehabilitation; Repair or reorganisation of neural tissue, e.g. after stroke
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36178 Burst or pulse train parameters
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

The present invention relates to a therapeutic system and methods of using the therapeutic system. In particular, the present invention relates to systems having hardware, software, and appliance components for assessing and entraining a neuromuscular pattern or behavior in a patient. The methods include configuring the hardware and software systems to receive data from an orofacial stimulation appliance and to generate a precise therapeutic pulse profile that is actuated as a tactile stimulus. In one embodiment, the system and methods also include collecting data using the orofacial stimulation appliance and delivering the tactile stimulus via the orofacial stimulation appliance to entrain an organized neuromuscular pattern or behavior.

Claims

1. A method for stimulating a suck central pattern generator and a trigeminal nerve in a brain of a human subject, such stimulation influencing brain response or brain development including repair of the brain, control of respiration, control of a non-nutritive suck pattern, mastication, and combinations thereof, the method comprising:

contacting the human subject with an appliance to stimulate one or more nerve ending near the subject'"'"'s mouth, including the facial region proximal to at least one lip and a tongue; and

,

actuating the appliance in response to a signal to generate a mechanical transfer of energy in at least one burst as an impulse sufficient to be recognized as a tactile stimulus by the subject'"'"'s suck central pattern generator;

wherein each burst comprises at least two square wave pulses of the same amplitude with the pulse period increasing with each successive pulse to form a decelerating pulse train sequence; and

,

wherein the square wave pulses range in frequency between 1.5 Hz and 5 Hz.

2. The method of claim 1, wherein at least six bursts in succession are contacted with the subject for at least two minutes at least twice a day.

3. The method of claim 1 wherein the square wave pulse displaces a surface of the appliance between about 150 microns and 300 microns for between 20 milliseconds and 50 milliseconds.

4. The method of claim 3, wherein the surface is displaced between about 260 microns and 300 microns.

5. The method of claim 3, wherein at least six bursts in succession are contacted with the subject for at least two minutes at least twice a day.

6. The method of claim 1 further comprising:

stimulating an olfactory or auditory region.

7. The method of claim 1 wherein the appliance comprises a textured nipple, a pneumatic pulse generator, and a baglet, and wherein the appliance is in communication with a software system.

8. The method of claim 1 wherein the appliance comprises a piezoelectric system.

9. The method of claim 1 wherein the appliance projects sound waves to generate the square wave pulses.

10. The method of claim 1, wherein the tactile stimulus is above background activity of the subject and the signal is a high velocity signal.

11. The method of claim 1 wherein the subject is an infant with a congenital heart defect, wherein the congenital heart defect prevents the infant from feeding efficiently.

12. The method of claim 1 wherein the subject is a stroke patient, wherein the patient is unable to receive nourishment efficiently.

13. A system for stimulating a central pattern generator and a trigeminal nerve in a brain of a human subject, such stimulation influencing brain response or brain development including repair of the brain, control of respiration, control of a non-nutritive suck pattern, mastication, and combinations thereof, the system comprising:

an orofacial stimulator appliance that, when actuated in response to a signal, generates a mechanical transfer of energy in at least one burst as an impulse sufficient to be recognized as a tactile stimulus by the subject'"'"'s central pattern generator;

wherein each burst comprises at least two square wave pulses of the same amplitude with the pulse period increasing with each successive pulse to form a decelerating pulse train sequence; and

,

wherein the square wave pulses range in frequency between 1.5 Hz and 5 Hz and are contacted with the subject for at least two minutes each day, at least twice a day for a minimum of five successive days.

14. The system of claim 13, wherein the orofacial stimulator appliance is in communication with a control application executable at a processor.

15. The system of claim 13, further comprising a pneumatic pulse generator that includes a PID controller and a pneumatic pulse generator, wherein the PID controller is an analog or real-time controller.

16. The system of claim 15, wherein the PID controller is a CompactRIO controller.

17. The system of claim 13, wherein each of the two or more square wave pulses comprises a harmonic of a base frequency.

18. The system of claim 13, wherein the harmonic for the two or more square wave pulses vary in frequency.

19. The system of claim 13, wherein the harmonic for the two or more pressure pulses are identical in frequency.

20. The system of claim 13, wherein each of the two or more pressure pulses have a damped harmonic profile.

21. The system of claim 20, wherein the damped harmonic oscillator profile of the two or more pressure pulses has a Q factor greater than or equal to ½

.

22. The system of claim 13, wherein the signal further comprises a rest period yielding no displacement to the orofacial stimulator appliance.

23. The system of claim 13, wherein the processing device further comprises:

a display device; and

,

an input device.

24. The system of claim 13, wherein the orofacial stimulator appliance further comprises:

a handpiece;

a receiver tube;

a receiver tube insert; and

,

a pacifier.

25. The system of claim 24, wherein the handpiece comprises a push-button switch in communication with a control application.

26. A method for stimulating a central pattern generator and a trigeminal nerve in an adult human brain of an adult subject, such stimulation influencing brain response or brain development including repair of the brain, control of respiration, control of a non-nutritive suck pattern, mastication, and combinations thereof, the method comprising:

contacting the adult subject with an appliance to stimulate one or more nerve ending near the subject'"'"'s mouth, including the facial region proximal to at least one lip and a tongue; and

,

actuating the appliance in response to a signal to generate a mechanical transfer of energy in at least one burst as an impulse sufficient to be recognized as a tactile stimulus by the subject'"'"'s central pattern generator;

wherein each burst comprises at least two square wave pulses of the same amplitude with the pulse period increasing with each successive pulse to form a decelerating pulse train sequence; and

,

wherein the square wave pulses range in frequency between 1.5 Hz and 5 Hz.

27. The method of claim 26 wherein the burst displaces a surface of the appliance between about 260 microns and 300 microns for between 20 milliseconds and 50 milliseconds, and wherein at least six bursts in succession are contacted with the adult subject for at least two minutes, at least twice a day.

28. The method of claim 26 wherein a motion induced by the burst has an amplitude ranging between 260 microns and 300 microns.

29. The method of claim 26 wherein the pulses in the burst decelerate.

30. The method of claim 26 wherein the adult is contacted with a burst that comprises six pulses.

31. The method of claim 29 wherein the decelerating pulse train has period intervals of 510, 526, 551, 580, and 626 ms.

32. The method of claim 28 wherein the pulses have frequencies of 1.7 Hz, 5.5 Hz, 9.0 Hz, 12.5 Hz, and 16.5 Hz.

33. A method of using a square wave to stimulate the central pattern generator nerve, the method comprising:

contacting a human subject with an appliance to stimulate one or more nerve ending near the subject'"'"'s mouth, including the facial region proximal to at least one lip and a tongue; and

,

actuating the appliance in response to a signal to generate a mechanical transfer of energy in at least one burst as an impulse sufficient to be recognized as a tactile stimulus by the subject'"'"'s central pattern generator;

wherein each burst comprises at least two square wave pulses of the same amplitude with the pulse period increasing with each successive pulse to form a decelerating pulse train sequence;

wherein the square wave pulses range in frequency between 1.5 Hz and 5 Hz; and

,

wherein at least six bursts in succession are contacted with the subject for at least two minutes, at least twice a day.