Enhanced therapeutic stimulus system and methods of use

• US 9,220,654 B2
• Filed: 10/31/2014
• Issued: 12/29/2015
• Est. Priority Date: 04/26/2012
• Status: Active Grant

• Current Assignee: Cardinal Health 200 LLC (Cardinal Health, Inc.)
• Original Assignee: Innara Health, Inc.
• Inventors: Barlow, Steven M., Stalling, David L., Aron, Kenneth
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Morales, Jon Eric C
• Application Number:
  US14/530,232
• Publication Number:
  US 20150100003A1
• Time in Patent Office: 424 Days
• Field of Search: 600/590
• US Class Current: 1/1
• 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 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;

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 and where the pneumatic pulse generator includes a linear motor further comprising a position feedback sensor and a pressure feedback sensor;

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.

2. The system of claim 1, wherein the pneumatic pulse generator is a position controlled pneumatic piston and cylinder having a position feedback sensor and a pressure feedback sensor, the pneumatic piston and cylinder being responsive to real-time input.

3. 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:

a control system for generating a pressure pulse signal at a pneumatic pulse generator assembly;

the pneumatic pulse generator assembly comprising;

a linear motor mechanically engaged to a piston of a pneumatic piston and cylinder, wherein the linear motor exerts force on the piston;

the pneumatic piston and cylinder to provide a pneumatic pressure pulse to the pliable pacifier through a pneumatic airline in response to the force applied to the piston; and

,

at least one feedback sensor to provide position feedback data and pressure feedback data of the piston motor;

an orofacial stimulator appliance comprising;

the pacifier in fluid engagement with a receiver tube, the receiver tube in fluid communication with the pneumatic airline to provide the pneumatic pressure pulse from the pneumatic piston and cylinder to the pacifier surface; and

,

a removable receiver tube insert received in the receiver tube to limit a total volume of air in receiver tube;

wherein pressure pulse is a burst comprising 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.

4. The system of claim 3, wherein a stimulus pattern of the pressure pulses cause the pacifier surface to have a net displacement of at least 260 μ

m.

5. The system of claim 3, wherein a first diameter of the pacifier during the first pressure pulse is at least 260 μ

m greater than a second diameter of the pacifier during the second pressure pulse.

6. The system of claim 4, wherein the stimulus pattern comprises:

six pressure pulses separated by interval periods of increasing duration, the six pressure pulses alternating between the positive displacement of the pacifier surface and the negative displacement of the pacifier surface.

7. The system of claim 5, wherein the stimulus pattern comprises:

six pressure pulses separated by interval periods of increasing duration, the six pressure pulses causing the positive displacement of the pacifier surface.

8. The system of claim 5, wherein the stimulus pattern comprises:

six pressure pulses separated by interval periods of increasing duration, the six pressure pulses causing the negative displacement of the pacifier surface.

9. The system of claim 6, wherein a first interval after the first pressure pulse has a duration of 510 milliseconds, a second interval after the second pressure pulse has a duration of 526 milliseconds, a third interval after a third pressure pulse has a duration of 551 milliseconds, a fourth interval after a fourth pressure pulse has a duration of 580 milliseconds, and a fifth interval after a fifth pressure pulse has duration of 626 milliseconds.

10. The system of claim 6, wherein the six pressure pulses are followed by a rest period yielding no displacement of the pacifier surface.

11. The system of claim 8, wherein the stimulus pattern is repeated at least once.

12. The system of claim 3, wherein the orofacial stimulator appliance further comprises:

a function switch to alternate between a therapy mode and an assessment mode, wherein the stimulus pattern is applied in the therapy mode and the non-nutritive suck pattern of the patient is assessed during the assessment mode;

an activation switch; and

a second pressure sensor.

13. The system of claim 3, wherein the receiver insert reduces the total volume of air in the receiver tube from 5.0 mL to 1.0 mL.

14. The system of claim 3 further comprising a laser micrometer, wherein the laser micrometer measures a frequency and the amplitude of the square wave pulses.