Enhanced therapeutic stimulus for non-nutritive suck entrainment system and method

• US 9,037,266 B2
• Filed: 04/26/2012
• Issued: 05/19/2015
• Est. Priority Date: 02/21/2008
• Status: Expired due to Fees

• Current Assignee: Innara Health, Inc., University of Kansas
• Original Assignee: Innara Health, Inc.
• Inventors: Barlow, Steven M., Stalling, David L., Aron, Kenneth
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): EDWARDS, PHILIP CHARLES
• Application Number:
  US13/457,203
• Publication Number:
  US 20120209148A1
• Time in Patent Office: 1,118 Days
• Field of Search: 607/134, 607/142, 600/590
• US Class Current: 607/134
• CPC Class Codes: A61B 5/038 Measuring oral pressure
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/6896 Toys
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5071 Pressure sensors
• CPC Class Codes: A61H 2205/022 Face
• CPC Class Codes: A61H 23/02 with electric or magnetic drive

Abstract

The present invention relates to a system and method for using the system. In particular, the present invention relates to an application, executable by a processing device to assess the organization of a non-nutritive suck (NNS) pattern of a patient and to entrain an organized NNS pattern in the patient. The software system receives data from an orofacial stimulation appliance to assess the patient'"'"'s natural NNS pattern and generates a precise therapeutic pulse profile that is actuated as a tactile stimulus via the orofacial stimulation appliance to entrain an organized NNS pattern.

Claims

1. A non-transitory system executable by a processor for stimulating a CPG and a trigeminal nerve in a human brain, such stimulation influencing brain response or development including repair, control of respiration, control of NNS, mastication, and combinations thereof, in a human brain comprising:

an assessment module to;

record a pressure signal received from a pressure transducer in an orofacial stimulator; and

,

generate a display signal to display assessment data based on the received pressure signal;

a feature extraction module to;

identify one or more components of a patient'"'"'s non-nutritive suck pattern in the pressure signal;

determine a symmetry of the patient'"'"'s non-nutritive suck pattern;

determine a repetition of the patient'"'"'s non-nutritive suck pattern; and

,

assign a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern, the spatiotemporal index value indicating an overall rating of the patient'"'"'s non-nutritive suck pattern; and

,

a therapy module to;

generate a therapeutic pressure pulse signal comprising a base frequency signal further comprising two or more pressure pulses, wherein each pressure pulse causes a displacement of a pacifier surface contacted by the lip and the mouth of the patient, wherein each of the two or more pressure pulses has a square wave profile and are separated by an interval between 500 milliseconds and 650 milliseconds in duration;

generate a therapeutic pressure profile signal comprising at least one of the therapeutic pressure pulse signals; and

,

transmit the therapeutic pressure pulse profile signal to the orofacial stimulator.

2. The system of claim 1, wherein the base frequency is between 1.5 Hz and 5 Hz.

3. The system of claim 2, wherein the two or more pressure pulses causes surface motion of between about 260 microns and 300 microns, with changes in the motion occurring at an interval between 20 milliseconds and 50 milliseconds.

4. The system of claim 3, wherein the therapeutic pressure profile comprises at least 6 pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day.

5. The system of claim 2, wherein each of the two or more pressure pulses comprises a higher order harmonic of the base frequency.

6. The system of claim 5, wherein the higher order harmonic decay for the two or more pressure pulses vary in an amplitude and a frequency.

7. The system of claim 5, wherein the higher order harmonic decay for the two or more pressure pulses are identical in an amplitude and a frequency.

8. The system of claim 2, wherein each of the two or more pressure pulses has a first order under damped response square wave profile.

9. The system of claim 8, wherein the under damped square wave profile of the two or more pressure pulses has a Q factor greater than or equal to ½

.

10. The system of claim 1, wherein the pressure transducer generates the pressure signal in response to pressure applied to the orofacial stimulator.

11. The system of claim 1, wherein the display signal contains waveform data, wherein the waveform data indicates at least one event in the pressure signal.

12. The system of claim 11, wherein the at least one event is identified as a pressure peak, a non-nutritive suck event, a burst, a chew, or combinations thereof.

13. The system of claim 1, wherein the spatiotemporal index value is based upon one or more suck symmetries, a suck quantity, and a burst timing of the patient'"'"'s non-nutritive suck pattern.

14. The system of claim 1, wherein the system further comprises a calibration module to calibrate the orofacial stimulator.

15. The system of claim 14, wherein the orofacial stimulator appliance is calibrated prior to:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

16. The system of claim 14, wherein the orofacial stimulator appliance is calibrated after:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

17. The system of claim 14, wherein the orofacial stimulator appliance is calibrated prior to and after:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

18. The system of claim 1, wherein the system further comprises a review module to review at least one of the assessment data, the generated therapeutic pressure profile, or both.

19. The system of claim 1, wherein the transmitted therapeutic pressure pulse profile signal is received at at least one of the pneumatic pressure transducer and the orofacial stimulator appliance.

20. A processing system encoded with an application for stimulating a CPG and a trigeminal nerve in a human brain, such stimulation influencing brain response or development including repair, control of respiration, control of NNS, mastication, and combinations thereof, in a human brain, the system comprising:

a processor;

memory; and

,

the application, executable by the processor, further comprising instructions to;

record a pressure signal received from a pressure transducer in an orofacial stimulator;

generate a display signal to display assessment data based on the received pressure signal;

identify one or more components of a patient'"'"'s non-nutritive suck pattern in the pressure signal;

determine a symmetry of the patient'"'"'s non-nutritive suck pattern;

determine a repetition of the patient'"'"'s non-nutritive suck pattern;

assign a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern, the spatiotemporal index value indicating an overall rating of the patient'"'"'s non-nutritive suck pattern;

generate a therapeutic pressure pulse signal comprising a base frequency signal further comprising two or more pressure pulses, wherein a first pressure pulse causes a positive displacement of a pacifier surface contacted by a lip and a mouth of the patient and a second pressure pulse causes a negative displacement of the pacifier surface contacted by the lip and the mouth of the patient, wherein each of the two or more pressure pulses has a damped square wave profile and are separated by an interval between 500 milliseconds and 650 milliseconds in duration;

generate a therapeutic pressure profile signal comprising at least one of the therapeutic pressure pulse signals; and

,

transmit the therapeutic pressure pulse profile signal to the orofacial stimulator.

21. The system of claim 20, wherein the base frequency is between 1.5 Hz and 5 Hz.

22. The system of claim 21, wherein the two or more pressure pulses causes surface motion of between about 260 microns and 300 microns, with changes in the motion occurring at an interval between 20 milliseconds and 50 milliseconds.

23. The system of claim 22, wherein the therapeutic pressure profile comprises at least 6 pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day.

24. The system of claim 21, wherein each of the two or more pressure pulse is a higher order harmonic decay of the base frequency.

25. The system of claim 24, wherein the higher order harmonic for the two or more pressure pulses varies in an amplitude and a frequency.

26. The system of claim 24, wherein the higher order harmonic for the two or more pressure pulses is identical in an amplitude and a frequency.

27. The system of claim 21, wherein each of the two or more pressure pulses has an under damped square wave profile.

28. The system of claim 27, wherein the under damped square wave profile of the two or more pressure pulses has a Q factor greater than or equal to ½

.

29. The system of claim 20, wherein the pressure transducer generates the pressure signal in response to pressure applied to the orofacial stimulator.

30. The system of claim 20, wherein the display signal contains waveform data, wherein the waveform data indicates at least one event in the pressure signal.

31. The system of claim 30, wherein the at least one event is identified as a pressure peak, a non-nutritive suck event, a burst, a chew, or combinations thereof.

32. The system of claim 20, wherein the spatiotemporal index value is based upon a suck symmetry, a suck quantity, and a burst timing of the patient'"'"'s non-nutritive suck pattern.

33. The system of claim 20, wherein the system further comprises a calibration module to calibrate the orofacial stimulator.

34. The system of claim 33, wherein the orofacial stimulator appliance is calibrated prior to:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

35. The system of claim 33, wherein the orofacial stimulator appliance is calibrated after:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

36. The system of claim 33, wherein the orofacial stimulator appliance is calibrated prior to and after:

receiving pressure signals at the assessment module, generating the therapeutic pressure pulse signal, or both.

37. The system of claim 20, wherein the system further comprises a review module to review at least one of the assessment data, the generated therapeutic pressure profile, or both.

38. The system of claim 20, wherein the transmitted therapeutic pressure pulse profile signal is received at a pressure transducer.

39. A non-transitory computer readable medium encoded with instructions for operating a system for delivering a non-nutritive suck stimulus to a patient, the instructions executable by a processor in communication with memory and comprising:

receiving, at the processor, a pressure signal received from a pressure transducer in an orofacial stimulator appliance;

generating a display signal to display assessment data based on the received pressure signal;

identifying one or more components of the patient'"'"'s non-nutritive suck pattern in the pressure signal;

determining a symmetry of the patient'"'"'s non-nutritive suck pattern;

determining a repetition of the patient'"'"'s non-nutritive suck pattern;

assigning a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern, the spatiotemporal index value indicating an overall rating of the patient'"'"'s non-nutritive suck pattern;

generating a therapeutic pressure pulse signal;

generating a therapeutic pressure profile signal comprising at least one of the therapeutic pressure pulse signals; and

,

transmitting the therapeutic pressure pulse profile signal to the orofacial stimulator appliance.

40. A non-transitory system executable by a processor for stimulating a human brain to organize a patient'"'"'s non-nutritive suck pattern, the system comprising:

an assessment module to;

record a pressure signal received from a pressure transducer in an orofacial stimulator appliance;

a feature extraction module to;

identify one or more components of the patient'"'"'s non-nutritive suck pattern in the pressure signal; and

assign a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern; and

,

a therapy module to;

generate a therapeutic pressure pulse signal comprising a damped square wave profile;

transmit the therapeutic pressure pulse profile signal to the orofacial stimulator appliance.

41. A processing system encoded with an application for stimulating a human brain to organize a patient'"'"'s non-nutritive suck pattern, the system comprising:

a processor;

memory; and

,

the application, executable by the processor, further comprising instructions to;

record a pressure signal received from a pressure transducer in an orofacial stimulator appliance;

identify one or more components of a patient'"'"'s non-nutritive suck pattern in the pressure signal;

assign a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern, the spatiotemporal index value indicating an overall rating of the patient'"'"'s non-nutritive suck pattern;

generate a therapeutic pressure pulse signal comprising a damped square wave; and

,

transmit the therapeutic pressure pulse profile signal to the orofacial stimulator appliance.

42. A non-transitory computer readable medium encoded with instructions for operating a system for delivering a non-nutritive suck stimulus to a patient, the instructions executable by a processor in communication with memory and comprising:

receiving, at the processor, a pressure signal received from a pressure transducer in an orofacial stimulator appliance;

identifying one or more components of the patient'"'"'s non-nutritive suck pattern in the pressure signal;

determining a symmetry of the patient'"'"'s non-nutritive suck pattern;

determining a repetition of the patient'"'"'s non-nutritive suck pattern;

assigning a spatiotemporal index value to the patient'"'"'s non-nutritive suck pattern, the spatiotemporal index value indicating an overall rating of the patient'"'"'s non-nutritive suck pattern;

generating a therapeutic pressure pulse signal; and

,

transmitting the therapeutic pressure pulse profile signal to the orofacial stimulator appliance.

43. The system of claim 42, wherein the instructions further comprise:

verify an expansion characteristic of the orofacial stimulator appliance in response to the therapeutic pressure pulse profile signal, wherein verification is performed by measuring a frequency and an amplitude component of a motion of the orofacial stimulator appliance.

44. The system of claim 43, wherein the instructions further comprise digitizing and recording the frequency and amplitude components.

45. The system of claim 43, wherein the frequency and the amplitude are measured by a laser micrometer.

46. A processing system encoded with an application for stimulating a human brain to organize a patient'"'"'s non-nutritive suck pattern, the system comprising:

a processor;

memory; and

,

the application, executable by the processor, further comprising instructions to;

record a pressure signal received from a pressure transducer in an orofacial stimulator appliance;

identify one or more components of a patient'"'"'s non-nutritive suck pattern in the pressure signal;

generate a therapeutic pressure pulse signal; and

,

transmit the therapeutic pressure pulse profile signal to the orofacial stimulator appliance.