Swallowing assessment and improvement systems and methods

• US 9,474,483 B2
• Filed: 08/12/2014
• Issued: 10/25/2016
• 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:
  US14/457,945
• Publication Number:
  US 20150045698A1
• Time in Patent Office: 805 Days
• Field of Search: 600/590
• US Class Current: 1/1
• 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 a flexible metal frame 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 when said intraoral device is placed into a subject'"'"'s mouth and first and second branches that extend perpendicularly outward from opposite sides of said central linear portion, each of said branches having a distal end;

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

a second 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 sensor at a boundary between a subject'"'"'s hard and soft palate when said intraoral device is placed into a subject'"'"'s mouth;

a third sensor at said distal end of said first branch; and

a fourth sensor at said distal end of said second branch;

b) a registration component at said proximal end of said central linear portion of said flexible metal frame, said registration component comprising first and second sub-components each comprising an interior opening through which said central linear portion is inserted and wherein a gap that fits said subject'"'"'s teeth or gum exists between said first and second sub-components; and

c) a computing device comprising a display and comprising a processor in electronic communication with said sensors wherein said processor is configured to display a diagnostic and therapeutic protocol to said subject that instructs said subject to actuate said sensors with the subject'"'"'s tongue over a period of time to improve lingual strength.

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

3. The system of claim 1, wherein said first and second sub-components of said registration component two sliding components configured to fit around the teeth or gum.

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

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 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. 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) assessing aspects of pressures generated for swallowing capability by measuring tongue pressure on said sensors using said computing device.

12. The method of claim 11, further comprising the step of providing said subject a swallowing therapeutic regime selected based on said assessed swallowing capability.

13. The method of claim 11, wherein the subject performs a 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 12, 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.

15. 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.