Devices, Systems, and Methods for Aiding in the Detection of a Physiological Abnormality

Abstract

The present invention comprises a method for identifying the presence or absence of a pulmonary embolism using a combination of tests and brightline thresholds. The first test is a blood based test measuring D-Dimer concentration and the second test is a respiratory analysis that determines a carboximetry ratio. If the measured D-Dimer value is at or above a threshold indicative of concern and the carboximetry value is equal to or less than a carboximetry ratio threshold, pulmonary embolism is present. If the measured D-Dimer value is at or above a threshold indicative of concern and the respiratory analysis yields a carboximetry ratio greater than the carboximetry ratio threshold, test results are inconclusive and additional testing is required to determine whether a pulmonary embolism is present.

1 - 20 . (canceled) 
     
     
         21 . A removable mouthpiece for a medical device to detect a physiological abnormality comprising:
 a substantially cylindrical body having a body first end defining a body first opening, a body second end defining a body second opening, and defining a substantially cylindrical air passage between the body first opening and the body second opening;   a conical filter having a filter first end of a filter first diameter and a closed filter second end of a filter second diameter, the filter second diameter smaller than the filter first diameter, defining a filter opening a the filter first end, defining an interior filter volume;   a support member supporting the filter in the air passage with the filter first end at the body first end.   
     
     
         22 . The removable mouthpiece of  claim 21  wherein the filter first diameter is substantially the same as the body first opening. 
     
     
         23 . The removable mouthpiece of  claim 21  wherein the filter is antimicrobial. 
     
     
         24 . The removable mouthpiece of  claim 21  wherein the filter second end of the filter extends through the body second end. 
     
     
         25 . The removable mouthpiece of  claim 21  wherein a ratio of the filter second diameter to the filter first diameter is between 1:2 and 1:4. 
     
     
         26 . The removable mouthpiece of  claim 25  wherein the ratio is about 3:8. 
     
     
         27 . The removable mouthpiece of  claim 21  wherein the filter defines a filter length, and where a ratio of the filter second diameter to the filter length is between 4:1 and 5:1. 
     
     
         28 . The removable mouthpiece of  claim 21  further comprising a conical spitguard mounted to the body, the spitguard defining a first spit guard diameter at the body first end, and a second spit guard diameter at the second end of the body, the second spitguard diameter larger than the first spit guard diameter. 
     
     
         29 . The removable mouthpiece of  claim 28  wherein the spitguard defines a pair of diametrically opposed finger grips. 
     
     
         30 . The removable mouthpiece of claim wherein the spitguard defines a plurality of key indentations for mating with the medical device. 
     
     
         31 . The removable mouthpiece of  claim 21  further comprising a flange unit mounted at the first end of body. 
     
     
         32 . The removable mouthpiece of  claim 31  further wherein the flange unit has a plurality of spaced apart bite tabs for holding a user's mouth in an open position. 
     
     
         33 . The removable mouthpiece of  claim 21  wherein the filter defines an external surface and an internal surface and the support member supports the internal and external surfaces. 
     
     
         34 . The removable mouthpiece of  claim 33  wherein the support member has a plurality of fins spaced about the external surface. 
     
     
         35 . The removable mouthpiece of  claim 33  wherein the support member has a plurality of fins spaced about the internal surface. 
     
     
         36 . The removable mouthpiece of  claim 34  wherein the support member has a plurality of fins spaced about the internal surface. 
     
     
         37 . The removable mouthpiece of  claim 21  wherein the filter is pleated. 
     
     
         38 . A removable mouthpiece for a medical device to detect a physiological abnormality comprising:
 a substantially cylindrical body having a body first end defining a body first opening, a body second end defining a body second opening, and defining a substantially cylindrical air passage between the body first opening and the body second opening;   a conical filter having a filter first end of a filter first diameter and a closed filter second end of a filter second diameter, the filter second diameter smaller than the filter first diameter, defining a filter opening a the filter first end, defining an interior filter volume, and closed at the second end; and   a support member supporting the filter in the air passage, with the filter first end at the body first end, and the support member extending along a surface of the filter.   
     
     
         39 . The removable mouthpiece of  claim 38  wherein the filter defines an external surface and an internal surface and the support member extends along the internal surface of the filter. 
     
     
         40 . The removable mouthpiece of  claim 38  wherein the filter defines an external surface and an internal surface and the support member extends along the external surface of the filter. 
     
     
         41 . The removable mouthpiece of  claim 39  wherein the support member extends along the internal surface of the filter.