Granted Patent B2

US 11,234,607 · App. 13/457,154 · Granted Feb 1, 2022

Inventors: Steven M. Barlow (Lawrence, KS); David L. Stalling (Shawnee, KS); Kenneth Aron (Shawnee, KS)

Assignees: Innara Health, Inc.; University of Kansas

A61B5/038A61B5/486A61B5/682A61B5/6896

Abstract

Claims (77)

1. A method for using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system to generate a productive non-nutritive suck pattern in a patient, the method comprising:

contacting the patient with the non-nutritive suck appliance assembly comprising an orofacial stimulator appliance, the orofacial stimulator appliance further comprising a pacifier, a receiver tube, and a receiver tube insert;

assessing a current non-nutritive suck pattern of the patient, wherein assessing the current non-nutritive suck pattern comprises:

at a user interface generated for display on a display device of the non-nutritive suck application system:

selecting the patient's name from a displayed list of patients generated by the non-nutritive suck application system, the non-nutritive suck application system having memory and executing a non-nutritive suck application on at least one processor;

selecting an assessment mode of the non-nutritive suck application;

selecting a displayed “new assessment” control button;

selecting an assessment session to be performed at the user interface; and,

configuring the assessment session at the user interface;

calibrating the orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected assessment session by inserting the receiver tube insert into the receiver tube of the orofacial stimulator appliance;

positioning the patient to encourage a rooting response to the orofacial stimulator appliance;

starting the assessment session;

inserting the orofacial stimulator appliance into the patient's mouth;

holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the assessment session; and,

inputting summary remarks regarding the assessment session at the user interface;

receiving an assessment waveform by the non-nutritive suck application from the orofacial stimulator appliance, wherein a feature extraction step identifies at least one of a most active two minute period having the most NNS events, pressure peaks, suck events, bursts, or chewing motions, wherein the feature extraction quantifies the overall performance of the patient's current non-nutritive suck pattern by assigning a Spatiotemporal Index (STI) value to the pattern;

reviewing the assessment waveform;

determining if a therapy protocol is necessary to generate the productive non-nutritive suck pattern; and,

providing a therapeutic stimulus to the patient, wherein providing the therapeutic stimulus comprises:

at the user interface generated for display on the display device of the non-nutritive suck application system:

selecting the patient's name from the displayed list of patients;

selecting a therapy mode of the non-nutritive suck application;

selecting a displayed “new therapy” control button; and,

configuring a therapy protocol to be performed;

calibrating the orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected therapy protocol by adjusting the receiver tube insert in the receiver tube of the orofacial stimulator appliance to control a total volume of air in the receiver tube;

positioning the patient to encourage a rooting response to the orofacial stimulator appliance;

starting the selected therapy protocol, wherein a therapeutic waveform is administered having therapeutic bursts with a decelerating pulse sequence;

inserting the orofacial stimulator appliance into the patient's mouth;

holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the therapy protocol; and,

inputting summary remarks regarding the therapy protocol at the user interface.

2. The method of claim 1 , wherein at least one of the assessment session or the therapy protocol is started by selecting a “start assessment” control button or a “start therapy” control button, respectively, at the user interface.

3. The method of claim 1 , wherein calibrating the orofacial stimulator appliance to perform the assessment session further comprises actuating a-pneumatic valve on the orofacial stimulator appliance.

4. The method of claim 1 , wherein the summary remarks comprise data regarding a state of alertness for the patient.

5. The method of claim 1 further comprising:

providing power to the non-nutritive suck application system;

providing power to the non-nutritive suck appliance assembly; and

logging in to the non-nutritive suck application.

6. The method of claim 1 further comprising:

adding a new patient to the displayed list of patients, wherein adding a new patient comprises:

entering new patient data at the user interface; and,

saving the new patient data in the memory of the non-nutritive suck application.

7. The method of claim 1 , wherein calibrating the orofacial stimulator appliance to perform the selected therapy protocol further comprises actuating a pneumatic valve on the orofacial stimulator appliance.

8. The method of claim 1 further comprising measuring a frequency and an amplitude of at least one pacifier displacement.

9. The method of claim 1 , wherein the step of holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the therapy protocol further comprises:

at the non-nutritive suck application system, generating a therapeutic pressure pulse profile 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.

10. The method of claim 1 , wherein the therapeutic pressure pulse profile signal comprises at least six pressure pulses in succession contacted with the patient for at least two minutes, at least twice a day.

11. The method of claim 1 wherein the STI value measures symmetry and repetition of the patient's current NNS pattern and is derived by integrating the symmetry and quantity of NNS events within the most active two minute period.

12. A method for using a non-nutritive suck appliance assembly in communication with a non-nutritive suck application system to generate a productive non-nutritive suck pattern in a patient, the method comprising:

contacting the patient with the non-nutritive suck appliance assembly comprising an orofacial stimulator appliance, the orofacial stimulator appliance further comprising a pacifier, a receiver tube, and a receiver tube insert;

assessing a current non-nutritive suck pattern of the patient, wherein assessing the current non-nutritive suck pattern comprises:

at a user interface generated for display on a display device of the non-nutritive suck application system:

selecting the patient's name from a displayed list of patients generated by the non-nutritive suck application system, the non-nutritive suck application system having memory and executing a non-nutritive suck application on at least one processor;

selecting an assessment mode of the non-nutritive suck application;

selecting a displayed “new assessment” control button;

selecting an assessment session to be performed at the user interface; and,

configuring the assessment session at the user interface;

calibrating the orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected assessment session by inserting the receiver tube insert into the receiver tube of the orofacial stimulator appliance;

positioning the patient to encourage a rooting response to the orofacial stimulator appliance;

starting the assessment session;

inserting the orofacial stimulator appliance into the patient's mouth;

holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the assessment session; and,

inputting summary remarks regarding the assessment session at the user interface;

receiving an assessment waveform by the non-nutritive suck application from the orofacial stimulator appliance, wherein a feature extraction step identifies at least one of a most active two minute period having the most NNS events, pressure peaks, suck events, bursts, or chewing motions, wherein the feature extraction quantifies the overall performance of the patient's current non-nutritive suck pattern by assigning a Spatiotemporal Index (STI) value to the pattern;

reviewing the assessment waveform;

determining if a therapy protocol is necessary to generate the productive non-nutritive suck pattern; and,

providing a therapeutic stimulus to the patient, wherein providing the therapeutic stimulus comprises:

at the user interface generated for display on the display device of the non-nutritive suck application system:

selecting the patient's name from the displayed list of patients;

selecting a therapy mode of the non-nutritive suck application;

selecting a displayed “new therapy” control button; and,

configuring a therapy protocol to be performed;

calibrating the orofacial stimulator appliance of the non-nutritive suck appliance assembly to perform the selected therapy protocol by adjusting the receiver tube insert in the receiver tube of the orofacial stimulator appliance to control a total volume of air in the receiver tube;

positioning the patient to encourage a rooting response to the orofacial stimulator appliance;

starting the selected therapy protocol, wherein a therapeutic waveform is administered having a square wave pulse period and transition intervals tuned to harmonic frequencies;

inserting the orofacial stimulator appliance into the patient's mouth;

holding the orofacial stimulator appliance to maintain contact with the patient's mouth during the therapy protocol; and,

inputting summary remarks regarding the therapy protocol at the user interface.

Assignments (9)

Continuity (4)