US2022323040A1PendingUtilityA1

Quality control protocols and methods for determining replacement and proper location for listening to body fluids

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Assignee: CVR GLOBAL INCPriority: Jun 15, 2016Filed: Jun 29, 2022Published: Oct 13, 2022
Est. expiryJun 15, 2036(~9.9 yrs left)· nominal 20-yr term from priority
A61B 7/00A61B 5/6886A61B 2562/046A61B 2560/0276A61B 2562/0204A61B 5/742A61B 5/7221A61B 5/6822A61B 5/02007A61B 5/7405
61
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Claims

Abstract

A method for determining proper placement of a sensor pod on a patient comprising: performing a first quality control procedure on a detection device comprising a base, at least two sensor pods, a computer system implementing appropriate software, and a display; wherein the first quality control procedure generates a tone from a speaker within said base and each sensor pod measures and compares sounds to predetermined measurements in real time; wherein a sensor pod has met quality control if said sounds are within 10% of predicted measurements; performing a second quality control procedure on said sensor pods, which measure sounds on a patient; wherein once engaged the system detects and compares sounds from sensor pods in real time to predicted sounds based on fluid flow vessels; and wherein said method provides an audio or visual alarm when said sensor pod is not detecting the predicted sounds, indicating an improper location.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for determining proper positioning of a sensor pod on a patient comprising:
 a. performing a first diagnostic test on a sensor pod wherein said first diagnostic test is performed using an self-diagnostic test comprising a base unit having a cradle for receiving said sensor pod, a speaker, a processing unit, a display, and at least one indicator;   b. wherein while the sensor pod is engaged in the cradle of the base unit, a predefined set of tones is played from the speaker and compared to the predefined set of tones for tolerance within 25% of a frequency of the predefined set of tones;   c. confirming proper function of the sensor pod within said 25% tolerance;   d. placing said sensor pod onto a patient in a first position wherein an active quality control procedure is performed;   e. detecting sounds from the patient and comparing the detected sounds in real time with an expected sound signature, wherein appropriate position is indicated when the detected sounds are within 25% of the frequency of the expected sound signature; and   f. wherein a second indicator is provided if said detected sounds are not within 25% of the frequency of the expected sound signature.   
     
     
         2 . The method of  claim 1  further comprising moving the sensor pod to a second position if the detected sounds are not within 25% of the frequency of the expected sound signature. 
     
     
         3 . The method of  claim 1  wherein another audio or visual alarm or mechanism may be further included so as to aid in placement of the sensor pod on a patient. 
     
     
         4 . The method of  claim 2  wherein a set of indicators identifies whether the second position is closer to the 25% tolerance or farther away from said 25% tolerance from said first position. 
     
     
         5 . The method of  claim 1  wherein the tolerance is 10%. 
     
     
         6 . A method of confirming proper positioning of a medical device upon a patient comprising performing the following steps in sequential order:
 a. performing a first quality control procedure to ensure functioning of sensor pods comprising playing a predetermined set of sounds from a base unit, wherein said sensor pods are adjacent to the base unit playing the predetermined set of sounds, detecting said predetermined set of sounds to create first detected sounds, and comparing the predetermined set of sounds to the first detected sounds;   b. performing a second quality control procedure by detecting second detected sounds from a patient wherein the second quality control procedure compares the second detected sounds to a predetermined sound signature corresponding to a particular artery or vessel of interest and from which the second detected sounds are being collected; and   c. triggering an alarm wherein the second detected sounds do not meet the predetermined sound signature or triggering an approval if the second detected sounds are within a predefined tolerance from the predetermined sound signature.   
     
     
         7 . The method of  claim 6  wherein the approval means that there is less than a 25% variance between the second detected sounds and the predetermined sound signature. 
     
     
         8 . The method of  claim 6  wherein in step (a), the step of comparing the predetermined set of sounds to the first detected sounds requires a tolerance of less than 25% variance to move to step (b). 
     
     
         9 . A method for performing a quality control procedure on a listening device comprising:
 a. a listening device having at least one sensing element and a base, said base comprising at least one speaker and a processing unit capable of playing a predetermined set of tones through said speaker;   b. playing a predetermined set of tones through said speaker;   c. detecting tones in said at least one sensing element;   d. comparing the predetermined set of tones to the detected tones;   e. providing an indicator that the predetermined set of tones is within a predetermined tolerance of the detected tones and indicating an approval if the detected tones are within said tolerance and a rejection if the detected tones are outside of said tolerance;   f. placing said sensing element on a patient adjacent to a carotid artery;   g. detecting sounds from the carotid artery;   h. comparing the sounds from the carotid artery to a predetermined carotid sound to create a comparison;   i. providing a notification that the detected sounds from the carotid artery are within a predetermined tolerance or a rejection if the detected sounds are outside of the predetermined tolerance; and   j. wherein if the detected sounds are within the predetermined tolerance, detecting sounds from the carotid artery and saving into storage for processing said sounds.   
     
     
         10 . The method of  claim 9  wherein the indicator is selected from the group consisting of: a tone, light, visual indication, audio indication, and combinations thereof. 
     
     
         11 . The method of  claim 9  wherein the notification is selected from the group consisting of: a tone, light, visual notification, audio notification, and combinations thereof. 
     
     
         12 . The method of  claim 9  wherein the indicator is provided on the base. 
     
     
         13 . The method of  claim 9  wherein the notification is provided on the at least one sensing element. 
     
     
         14 . The method of  claim 9  wherein the indicator and the notification are the same. 
     
     
         15 . The method of  claim 9  wherein step (i) further comprises replacing said sensing element if a rejection is provided and restarting the quality control procedure. 
     
     
         16 . The method of  claim 9  wherein step (i) further comprises replacing said sensing element if a notification is provided and restarting the quality control procedure. 
     
     
         17 . The method of  claim 9  wherein step (i) further comprises indicating success if said comparison is within 25% of said predetermined tolerance with regard to frequency or indicating failure if said comparison is outside of 25% of said predetermined tolerance with regard to frequency and moving said sensing element on said patient until a success is indicated on said patient. 
     
     
         18 . The method of  claim 9  wherein step (e) further comprises comparing said detected tones to said predetermined set of tones; indicating success of said quality control procedure if said detected tones are within 25% of a frequency of said predetermined set of tones; indicating failure of said quality control procedure if said detected tones are more than 25% of the frequency of said predetermined set of tones; and replacing said sensing element and restarting the method at step (b).

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