Apparatuses and methods for diagnosing swallowing dysfunction

Abstract

The present disclosure is directed to apparatuses and methods for diagnosing a swallowing dysfunction. The apparatus may include a multi-parametric dysphagia analysis system in a plastic foil. The analysis systems may be smart sensing systems that are flexible, lightweight, and based on substrates having low-cost printed electronics technologies thereon. The methods may include measurement and classification of non-invasive parameters that may be indicative of a swallowing dysfunction or the probability of same. In a general embodiment, the methods include placing a sensor on a patient for measurement of at least one parameter associated with the patient's swallowing profile. The measured parameter is then analyzed and compared with several known normal and dysphagic swallowing profiles to provide an indication of the probability of an underlying swallowing dysfunction.

The invention is claimed as follows: 
     
         1 . A device comprising:
 a flexible substrate;   at least one printed electronic selected from the group consisting of a microcontroller, at least one sensor, an antenna, and combinations thereof; and   the flexible substrate and at least one printed electronic are encased in a plastic foil.   
     
     
         2 . The device according to  claim 1 , wherein the flexible substrate comprises a polymer selected from the group consisting of polyethylene napthalate (“PEN”), polyethylene terephthalate (“PET”), and combinations thereof. 
     
     
         3 . A swallowing test apparatus comprising:
 a device comprising a flexible substrate and at least one printed electronic selected from the group consisting of a microcontroller, at least one sensor, an antenna, and combinations thereof, wherein the flexible substrate and at least one printed electronic are encased in a plastic foil; and   a patient database containing statistically-significant data relating to at least one swallowing profile.   
     
     
         4 . The swallowing test apparatus according to  claim 3  further including a processing device, the processing device configured to compare a sensor output to known swallowing disorders or dysfunctions stored in the patient database. 
     
     
         5 . A swallowing test apparatus comprising:
 a device comprising a flexible substrate, and at least one printed electronic selected from the group consisting of a microcontroller, at least one sensor, an antenna, and combinations thereof, wherein the flexible substrate and at least one printed electronic are encased in a plastic foil;   a computer; and   a computer readable medium accessible to the computer and containing an interpretive algorithm therein, wherein the interpretive algorithm is programmed to cause a computer processor to model a probability of an underlying swallowing dysfunction.   
     
     
         6 . The swallowing test apparatus according to  claim 5 , wherein the at least one sensor is configured to sense at least one parameter selected from the group consisting of pressure, sound waves, acceleration, velocity, distance, electrical current, voltage, electromagnetic radiation, temperature, and combinations thereof. 
     
     
         7 . The swallowing test apparatus according to  claim 5 , wherein the at least one sensor is reusable and/or disposable. 
     
     
         8 . The swallowing test apparatus according to  claim 5 , wherein the computer processor is configured to compare a sensor output to related parameters associated with known swallowing disorders or dysfunctions. 
     
     
         9 . The swallowing test apparatus according to  claim 5 , wherein the interpretive algorithm is programmed to cause the computer processor to interpret a sensor output, the sensor output being at least one quantitative or at least one qualitative measure of a dysfunction selected from the group consisting of mechanical, biomechanical, neurological, and combinations thereof. 
     
     
         10 . A method of diagnosing a dysfunction, the method comprising:
 placing a sensor on a patient, the sensor comprising a flexible substrate, and at least one printed electronic selected from the group consisting of a microcontroller, at least one sensor, an antenna, and combinations thereof, wherein the flexible substrate and at least one printed electronic are encased in a plastic foil;   measuring a level of function of an anatomical structure involved in swallowing;   the sensor communicating with a device that accepts a sensor output representative of the level of function;   evaluating the sensor output to obtain a result; and   outputting the result of the evaluation.   
     
     
         11 . The method according to  claim 10 , wherein the anatomical structure is selected from the group consisting of jaw, lips, soft palate, tongue, hyoid, epiglottis, larynx, pharynx, upper esophageal sphincter, and combinations thereof. 
     
     
         12 . The method according to  claim 10 , wherein the level of function is selected from the group consisting of low, normal, high poor, excellent and combinations thereof. 
     
     
         13 . The method according to  claim 10 , wherein the level of function relates to at least one function selected from the group consisting of lip closure, jaw closure, anchoring of the tongue, tongue lift, tongue control, tongue sweep, tongue seal, soft palate seal, mouth breathing, nasal breathing, lingual propulsion, tongue pressure, laryngeal elevation, hyoid movement, hyolaryngeal excursion, upper esophageal sphincter opening, epiglottis movement, larynx opening, vocal fold closure, laryngeal sensation, pharyngeal contraction, pharyngeal fatigue, laryngeal adductor reflex, laryngeal fatigue, respiration halting, respiration recommencement, and pharyngeal sensation.