Swallowing assessment and improvement systems and methods

• US 9,974,473 B2
• Filed: 10/21/2016
• Issued: 05/22/2018
• Est. Priority Date: 08/12/2013
• Status: Active Grant

• Current Assignee: Progia Medical Incorporated
• Original Assignee: Swallow Solutions, Llc
• Inventors: Gribb, Tye, Robbins, JoAnne, Hind, Jackie, Peterman, John
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US15/331,337
• Publication Number:
  US 20170035345A1
• Time in Patent Office: 578 Days
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/4205 Evaluating swallowing
• CPC Class Codes: A61B 5/4803 Speech analysis specially adapted for diagnostic purposes
• CPC Class Codes: A61B 5/682 Mouth, e.g., oral cavity; tongue; Lips; Teeth
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence

Abstract

The present disclosure relates to devices, systems, and methods for assessing and altering swallowing, speech, and breathing function. In particular, the present disclosure relates to devices and systems to assess and improve speech, breathing, and swallowing function in subjects in need thereof.

Claims

1. A system for assessing swallowing function, comprising:

a) an intraoral device comprising an adjustably bendable metal frame configured to be placed in a subject'"'"'s mouth, said device, when placed in the subject'"'"'s mouth having a central linear portion comprising a proximal end positioned towards an anterior opening of a mouth and a distal end positioned towards a back of the mouth;

a first pressure sensor positioned on a first region of said frame; and

a second pressure sensor positioned on a second region of said central linear portion of said frame near said distal end of said central linear portion, wherein said second region of said central linear portion of said frame positions said second pressure sensor at a boundary between a subject'"'"'s hard and soft palate when said intraoral device is placed into a subject'"'"'s mouth; and

b) a computing device comprising a display and comprising a processor in electronic communication with said pressure sensors wherein said processor displays a diagnostic and therapeutic protocol to said subject that instructs said subject to actuate said pressure sensors with the subject'"'"'s tongue over a period of time to improve lingual strength, wherein said protocol comprises;

i) determining baseline maximum tongue pressure on said first or second pressure sensor;

ii) selecting a therapeutic goal;

iii) during a first time period, directing a plurality of tongue press repetitions of said first and second sensors at a pressure that is a percentage of said baseline maximum tongue pressure;

iv) during a later second time period, directing a plurality of tongue press repetitions of said first and second sensors at a pressure that is an increased percentage of said baseline maximum tongue pressure;

v) during a later third time period, re-measuring maximum lingual pressures at said first and second sensors and selecting a new therapeutic goal that is a percentage based the re-measured maximum lingual pressures; and

vi) directing a plurality of tongue press repetitions of said first and second sensors based on said new therapeutic goal; and

vii) repeating steps v) and vi) one or more times.

2. The system of claim 1, wherein said frame is stainless steel.

3. The system of claim 1, wherein said pressure sensors are located on an upper or lower surface of said frame.

4. The system of claim 1, wherein said pressure sensors comprise solid state pressure sensors.

5. The system claim 1, wherein said pressure sensors are polymer thick film (PTF) sensors that exhibit a decrease in resistance with increase in force applied to the surface of the sensor.

6. The system claim 1, wherein the computing device comprises a computer chip with a unique serial number.

7. The system of claim 1, wherein said frame has a composition and shape that provides tensile strength, malleability, and ductability sufficient to withstand stress associated with bending up to 90 degrees.

8. The system of claim 1, wherein said device further comprises a communication component that transmits information from said pressure sensors to said computing device.

9. The system of claim 8, wherein said communication component is a wireless communication component.

10. The system of claim 1, wherein said computing device comprises a tablet computer.

11. The system of claim 1, wherein said diagnostic and therapeutic protocol involves said computing device assessing sensor press direction, rest periods between sensor presses, target duration, and repetition count.

12. A method of assessing swallowing function, comprising:

a) placing the intraoral device of the system of claim 1 within a mouth of a subject;

b) bending said frame to position said sensors against a roof of said mouth;

c) running said protocol comprising;

i) determining baseline maximum tongue pressure on said first or second pressure sensor;

ii) selecting a therapeutic goal;

iii) during a first time period, directing a plurality of tongue press repetitions of said first and second sensors at a pressure that is a percentage of said baseline maximum tongue pressure;

iv) during a later second time period, directing a plurality of tongue press repetitions of said first and second sensors at a pressure that is an increased percentage of said baseline maximum tongue pressure;

v) during a later third time period, re-measuring maximum lingual pressures at said first and second sensors and selecting a new therapeutic goal that is a percentage based the re-measured maximum lingual pressures; and

vi) directing a plurality of tongue press repetitions of said first and second sensors based on said new therapeutic goal; and

vii) repeating steps v) and vi) one or more times.

13. The method of claim 12, wherein the subject performs the therapeutic protocol with said device, the device generates and sends metrics relating to the therapeutic protocol to a secure server, the secure server generates and sends alerts and/or reports relating to the therapeutic protocol to a clinician device, the clinician device sends messages informed by the alerts and/or reports to the device directly or indirectly via the secure server, and a protocol of the device is modified by the messages from the clinician device.

14. The method of claim 13, wherein said assessing and therapeutic regime comprises the steps of:

a) in a first week, fitting said intraoral device to a mouth of a subject and determining baseline maximum tongue pressures on 1 or more sensors and identifying a therapeutic goal;

completing 10 lingual press repetitions on each sensor, 3 times per day on 3 days in said first week at 60% of therapeutic goal;

b) in a second week, completing 10 lingual press repetitions on each targeted sensor with an increased baseline maximum 3 times per day on 3 days per said second week;

c) in a third week, re-measure maximum lingual pressures at 1 or more sensors and adjust therapy goals to 80% of new maximum values;

completing 10 lingual press repetitions on each targeted sensor with the new goals, 3 times per day on 3 days per said third week; and

d) repeat step c one or more times.