Apparatus, method and system for determining a physiological condition within a mammal

Abstract

A system, method and apparatus for determining a physiological condition within a mammal based on pH and/or temperature measurements. In one aspect, the invention is an apparatus for measuring a physiological condition within a mammal comprising: a probe for insertion into a body lumen of the mammal, the probe housing a first circuit board operably coupling a pH sensor for measuring pH and generating a pH signal indicative of the measured pH, a memory device storing parametric data unique to the pH sensor, and a first interface connector located at a proximal portion of the probe; a handle for manipulating the probe, the handle housing a second circuit board operably coupling a microprocessor for processing the pH signal, and a second interface connector; the probe connected to the handle in a manner that allows the probe and handle to be repetitively engaged and disengaged from each other.

What is claimed is: 
     
         1 . An apparatus for measuring a physiological condition within a mammal comprising:
 an elongated probe for insertion into a body lumen of the mammal, the probe comprising a first circuit board operably coupling a pH sensor for measuring pH within the body lumen and generating a pH signal indicative of the measured pH, a memory device storing parametric data unique to the pH sensor and a first interface connector located at a proximal portion of the probe;   a handle for manipulating the probe, the handle comprising a second circuit board operably coupling a microprocessor for processing the pH signal and generating an output signal based on the processing of the pH signal, a display device for displaying the output signal generated by the microprocessor, and a second interface connector;   the probe connected to the handle in a manner that allows the probe and handle to be repetitively engaged and disengaged from each other; and   wherein when the probe is connected to the handle, the first and second interface connectors are in electrical connection so that the microprocessor can retrieve the parametric data from the memory device of the probe and receive the pH signal.   
     
     
         2 . The apparatus of  claim 1  wherein the pH sensor is an ion-sensitive field, effect transistor (ISFET) and wherein the parametric data includes first ISFET slope data determined at ambient temperature and second ISFET slope data determined at normal body temperature, and wherein the first and second ISFET slope data is based on at least three points of pH parametric data. 
     
     
         3 . The apparatus of  claim 1  further comprising:
 the probe comprising a temperature sensor for measuring temperature within the body lumen and generating a temperature signal indicative of the measured temperature, the temperature sensor operably coupled to the first circuit board; and 
 wherein the microprocessor processes the temperature signal and generates the output signal based on the processing of the pH signal and/or the temperature signal. 
 
     
     
         4 . The apparatus of  claim 3  wherein the elongated probe has a distal portion, the pH sensor and the temperature sensor located at the distal portion. 
     
     
         5 . The apparatus of  claim 4  wherein the handle further comprises a socket forming as passageway into the handle, the second interface connector aligned with the socket, and wherein when the probe is connected to the handle, the proximal portion of the probe extends into the socket of the handle, and wherein the probe and the handle are connected together by one of a tight-fit engagement, a threaded engagement, and a snap-fit engagement. 
     
     
         6 . The apparatus of  claim 3  wherein the handle further comprises a power source located within the handle and user controls located, on the handle and operably coupled to the second circuit board, the power source providing power to the second circuit board and to the first circuit board when the probe is secured to the handle. 
     
     
         7 . The apparatus of  claim 3  wherein the probe further comprises a first internal chamber, a second internal chamber, and a diaphragm, the first circuit board located within the first internal chamber, and the second chamber being hermetically sealed and filed with an electrolyte solution buffered at a known pH, and the diaphragm having a first portion in contact with the electrolyte solution and a second portion exposed to the body lumen. 
     
     
         8 . The apparatus of  claim 7  wherein the probe extends along a longitudinal axis and wherein the temperature sensor, the pH sensor and the diaphragm are aligned along, an axis that is substantially parallel to the longitudinal axis. 
     
     
         9 . The apparatus of  claim 8  wherein the temperature sensor, the pH sensor and the diaphragm are located on a substantially planar floor of a well formed into a distal portion of the probe. 
     
     
         10 . The apparatus of  claim 1  wherein the apparatus is adapted for use when the body lumen is a vagina, and wherein the handle further comprises a second memory device operably coupled to the second circuit board, the second memory device storing algorithms for identifying a fertility period based on cervical pH and/or temperature. 
     
     
         11 . An apparatus for measuring a physiological condition within a mammal comprising:
 an elongated probe for insertion into a body lumen of the mammal, the probe comprising a first circuit hoard operably coupling an ion-sensitive field effect transistor (ISFET) for measuring pH within the body lumen and generating a pH signal indicative of the measured pH, a temperature sensor for measuring temperature within the body lumen and generating a temperature signal indicative of the measured temperature, a diaphragm in contact with an electrolyte solution buffered at a known pH, a memory device storing ISFET slope data at both ambient temperature and normal body temperature for the ISFET, and a first interface connector located at a proximal portion of the probe;   a handle for manipulating, the probe, the handle comprising a second circuit board operably coupling a microprocessor for receiving the pH and temperature signals and generating an output signal based on the processing of the pH and temperature signals and the ISFET slope data, a display device for displaying the output signal generated by the microprocessor, and a second interface, connector;   the probe connected to the handle in a manner that allows the probe and handle to be repetitively engaged and disengaged front each other; and   wherein when the probe is connected to the handle, the first and second interface connectors are in electrical connection so that the microprocessor can retrieve the ISFET slope data from the memory device of the probe and receive the pH and temperature signals.   
     
     
         12 . The apparatus of  claim 11  wherein the elongated probe has a distal portion, the temperature sensor and the diaphragm located at the distal portion. 
     
     
         13 . The apparatus of  claim 12  wherein the handle further comprises a socket forming a passageway into the handle, the second interface connector aligned with the socket, and wherein when the probe is connected to the handle, the proximal portion of the probe extends into the socket of the handle. 
     
     
         14 . The apparatus of  claim 11  wherein the temperature sensor is a thermistor covered by a metal cap that is exposed through a first opening in a wall of the probe, wherein the ISFET is exposed through a second opening in the wall of the probe, and wherein the diaphragm is exposed through a third opening in the wall of the probe. 
     
     
         15 . The apparatus of  claim 14  wherein the probe extends along a longitudinal axis, and wherein the first, second and third openings in the wall of the probe are aligned along an axis that is substantially parallel to the longitudinal axis. 
     
     
         16 . The apparatus of  claim 14  wherein a seal is formed between each of the metal cap and the ISFET and the wall of the probe so that fluids from the body lumen can not reach the second circuit board through the first and/or second openings. 
     
     
         17 . The apparatus of  claim 11  wherein the handle further comprises a power source located within the handle, the power source providing power to the second circuit board and to the first circuit board when the probe is secured to the handle. 
     
     
         18 . An apparatus for measuring a physiological condition within a mammal comprising:
 a probe for insertion into a body lumen of the mammal, the probe comprising a first circuit board operably coupling a pH sensor for measuring pH within the body lumen and generating a pH signal indicative of the measured pH and a memory device storing parametric data unique to the pH sensor;   a handle for physically manipulating the probe, the handle comprising a second circuit board having a microprocessor for processing the pH signal and generating an output signal based on the processing of the signal;   the probe connected to the handle in a manner that allows the probe and the handle to be repetitively engaged and disengaged from each other; and   wherein when the probe is connected to the handle, the first and second circuit boards are in electrical connection so that the microprocessor can retrieve the parametric data from the memory device of the probe and receive the pH signal.   
     
     
         19 . The apparatus of  claim 18  wherein the first circuit board operably couples a first interface connector with the pH sensor and the memory device and wherein the second circuit board operably couples a second interface connector with the microprocessor. 
     
     
         20 . The apparatus of  claim 19  wherein the handle further comprises a socket forming a passageway into the handle, the second interface connector aligned with the socket, and wherein when the probe is connected to the handle, a proximal portion of the probe extends into the socket of the handle thereby electrically connecting the first interface connector and the second interface connector.