APPARATUS, METHOD AND SYSTEM FOR DETERMINING A PHYSIOLOGICAL CONDITION WITHIN A MAMMAL

• US 20100036212A1
• Filed: 08/05/2009
• Published: 02/11/2010
• Est. Priority Date: 08/05/2008
• Status: Abandoned Application

• Current Assignee: PH Diagnostics, Inc.
• Original Assignee: PH Diagnostics, Inc.
• Inventors: Rieth, Harry T.
• Application Number:
  US12/536,025
• Publication Number:
  US 20100036212A1
• Time in Patent Office: Days
• US Class Current: 600/301
• CPC Class Codes: A61B 10/0012 Ovulation-period determination for animals A61D17/002
• CPC Class Codes: A61B 2010/0019 based on measurement of temperature
• CPC Class Codes: A61B 2010/0032 based on measurement of pH-value
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/4277 saliva secretion
• CPC Class Codes: A61B 5/4294 vaginal secretions
• CPC Class Codes: A61B 5/4337 of the vagina
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

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 directed to 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 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 potion 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 generating an output signal based on the processing of the pH signal, an indicia device for communicating 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 operable connection so that the microprocessor can retrieve the parametric data from the memory device of the probe and receive the pH signal.

Claims

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 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).

3. The apparatus of claim 2 wherein the parametric data includes ISFET slope data.

4. The apparatus of claim 2 wherein the parametric data includes first ISFET slope data determined at ambient temperature and second ISFET slope data determined at normal body temperature.

5. The apparatus of claim 4 wherein the first and second ISFET slope data is based on at least three points of pH parametric data.

6. 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.

7. The apparatus of claim 6 wherein the pH sensor is an ISFET and the parametric data includes first ISFET slope data determined at ambient temperature and second ISFET slope data determined at normal body temperature.

8. The apparatus of claim 6 wherein the elongated probe has a distal portion and a proximal portion, the pH sensor and the temperature sensor located at the distal portion and the first interface connector is located at the proximal portion.

9. The apparatus of claim 8 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.

10. The apparatus of claim 9 wherein the probe and the handle are connected together by one of a tight-fit engagement, a threaded engagement, and a snap-fit engagement.

11. The apparatus of claim 8 wherein the probe extends along a longitudinal axis, and wherein the temperature sensor and pH sensor are aligned along an axis that is substantially parallel to the longitudinal axis.

12. The apparatus of claim 6 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.

13. The apparatus of claim 12 wherein the handle further comprises user controls located on the handle and operably coupled to the second circuit board.

14. The apparatus of claim 6 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.

15. The apparatus of claim 14 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.

16. The apparatus of claim 15 wherein the temperature sensor, the pH sensor and the diaphragm are located within a well formed into a distal portion of the probe.

17. The apparatus of claim 16 wherein the temperature sensor, the pH sensor and the diaphragm are located on a substantially planar floor of the well.

18. The apparatus of claim 1 wherein the body lumen is the vagina and 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 or cervical pH and/or temperature.

28. The apparatus of claim 2 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 printed circuit board through the first and/or second openings.

19. 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 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 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 ISFET slope data from the memory device of the probe and receive the pH and temperature signals.

20. The apparatus of claim 19 wherein the elongated probe has a distal portion and a proximal portion, the ISFET, the temperature sensor and the diaphragm located at the distal portion and the first interface connector located at the proximal portion.

21. The apparatus of claim 20 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.

22. The apparatus of claim 21 wherein the probe and the handle are connected together by one of a tight-fit engagement, a threaded engagement, and a snap-fit engagement.

23. The apparatus of claim 19 wherein the probe extends along a longitudinal axis, and wherein the temperature sensor, the diaphragm and the ISFET are aligned along an axis that is substantially parallel to the longitudinal axis.

24. The apparatus of claim 19 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.

25. The apparatus of claim 24 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.

27. The apparatus of claim 24 wherein a space between the thermistor and the metal cap is filled with a thermally conductive epoxy that is not electrically conductive.

29. The apparatus of claim 24 wherein the temperature sensor, the pH sensor and the diaphragm are located within a well formed into a distal portion of the probe.

30. The apparatus of claim 19 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.

31. The apparatus of claim 30 wherein the handle further comprises user controls located on the handle and operably coupled to the second circuit board.

32. The apparatus of claim 19 wherein the body lumen is the vagina and 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.

33. 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;

an elongated tubular housing extending along a longitudinal axis from a proximal end to a distal end, the elongated tubular housing having a first internal cavity;

a first circuit board located within the first internal cavity;

a pH sensor for measuring pH within the body lumen located at a distal portion of the elongated tubular housing, the pH sensor generating a pH signal indicative of the measured pH and operably coupled to the first circuit board;

a temperature sensor for measuring temperature within the body lumen located at the distal portion, the temperature sensor generating a temperature signal indicative of the measured temperature and operably coupled to the first circuit board;

a first memory device storing parametric data unique to the pH sensor, the memory device housed within the internal cavity of the elongated tubular housing and operably coupled to the first circuit board; and

a first interface connector located at a proximal portion of the elongated tubular housing and operably coupled to the circuit board;

a handle for manipulating the probe, the handle comprising;

a second housing having a second internal cavity and a socket forming a passageway into the second internal cavity;

a second circuit board located within the second internal cavity;

a microprocessor located within the second housing and operably coupled to the second circuit board for receiving and processing the pH signal and the temperature signal, the microprocessor generating an output signal based on the processing of the pH signal and the temperature signal and the parametric data;

a power source located within the second housing and operably coupled to the second circuit board;

user controls located on the second housing and operably coupled to the second circuit board;

a display device operably coupled to the second circuit board for displaying the output signal generated by the microprocessor;

a second interface connector operably coupled to the circuit board and aligned with the socket; and

wherein the probe is removably secured to the handle, the proximal portion of the elongated tubular housing extending into the socket of the second housing so at the first and second connectors are in electrical connection.