Automatic allergy detection system

• US 4,819,657 A
• Filed: 06/16/1987
• Issued: 04/11/1989
• Est. Priority Date: 04/12/1985
• Status: Expired due to Fees

• Current Assignee: KVM Engineering, Inc.
• Original Assignee: KVM Engineering, Inc.
• Inventors: Meador, James W., Kraft, Thomas L., Vick, Howard A.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Shay, David
• Application Number:
  US07/060,974
• Time in Patent Office: 665 Days
• Field of Search: 128/736, 128/743, 128/664, 128/414 R
• US Class Current: 600/549
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis

Abstract

Disclosed herein is an automatic allergy testing system. The system includes an electrode capable of testing up to eight different allergies and an associated electronic unit. The electrode includes apparatus to transcutaneously deliver an allergen to the patient without puncturing the patient'"'"'s skin. The electrode also includes a temperature sensor for sensing the skin temperature in the area surrounding the delivery of the allergen. Electronic apparatus is provided for processing the sensed temperature and storing data related thereto for subsequent print out to an output device. The allergy testing system is controlled so that periodic temperature readings are made at thrity second intervals over approximately a fifteen minute testing span. The data can be printed out in a graphic format to allow the physician to easily and quickly make more accurate diagnosis.

Claims

1. A system for measuring allergic response, including:

allergen delivery means for transcutaneously delivering an ionizable selected substance into the skin of a subject to test for allergic response of the subject to said substance, said means including charging and return electrodes positioned for spaced topical placement on the subject'"'"'s skin effective to provide a conductive path through the tissue of the skin for transcutaneous transport of said selected substance, said charging electrode including a charging member responsive to a first electric signal and, in contact with said charging member, a medium for containing said selected substance, said medium being positioned to separate said charging member from contact with the skin upon said topical placement of said charging electrode;

temperature sensing and signaling means adapted for placement in thermal contact with an area of skin of the subject at a location in juxtaposition with said path, for sensing instantaneous temperature of the skin at said location and for outputting a second electric signal manifesting said instantaneous temperature;

processing control means for controlling the application of said first electric signal and for receiving and processing said second electric signal, said processing control means including sampling and storing means for sampling said second signal during a plurality of times and for storing data manifesting the sensed temperature for each sampling time, and

means for providing an output of the stored data indicating change in temperature of said area of skin with respect to time.

2. The invention of claim 1 in which said temperature sensing and signaling means includes (a) thermal pickup means for sensing the temperature of the said area of skin, and (b) transducer means in thermal communication with said pickup means for converting said communicated sensed temperature into said second electric signal.

3. The invention of claim 2 in which said second electric signal is an analog signal having an instantaneous amplitude related to a sensed instantaneous temperature, wherein said processing control means includes analog to digital converter means for converting said received second electric signal into a digital signal, and wherein said sampling means includes clock means for generating a plurality of sampling signals each at a periodic interval to cause said sampling to automatically occur.

4. The invention of claim 3 in which said transducer means is a thermistor.

5. The invention according to claim 3 wherein said sampling and storing means includes microprocessor means and memory means, said microprocessor means responding to said sampling signals for reading digital data from said converter means and storing said read digital data in said memory means.

6. The invention according to claim 5 wherein said sampling and storing means further includes means to disable power application to said converter means and said process control means, except during said sampling time.

7. The invention according to claim 6, including means for application of said sampling signal to said microprocessor means and means responsive thereto to initiate a sampling and storing of said data by said microprocessor means only during the duration of said sampling signal, said microprocessor means being placed in an inactive state until the occurence of a next succeeding sampling signal.

8. The invention according to claim 7 wherein said means for providing an output includes connector means of a type adapted for connection to an output indicator means, said microprocessor means having means providing a signal to said connector means for controlling said output indicator means to indicate said output.

9. A system for measuring allergic response of the skin of a subject, comprising:

containing means for containing a hydrolyzable allergen, said containing means having (i) a first surface adapted to contact said skin of a subject, and (ii) a second surface adapted to be contacted by a charging member;

a charging member contacting said second surface of said allergen containing means;

means for providing an electric charge to said allergen whereby said allergen is transcutaneously delivered to said subject;

means adapted for placement in thermal contact with said skin at a test area proximate said allergen containing means, including (a) thermal pickup means for sensing instantaneous temperature of the said skin at said area, and (b) transducer means, in thermal communication with said pickup means, for converting said instantaneous temperature into an output signal manifesting said instantaneous temperature, said thermal pickup means having an opening therein within which, thermally and electrically insulated from said pickup means, said allergen containing means and said charging member are positioned;

clock means for providing a plurality of sampling signals each at a predetermined periodic interval related to a desired frequency of sampling during a selected duration of measurement of temperature rate of change of an allergic response to be measured;

storing means responsive to said output signal and each of said sampling signals for storing data indicating the temperature manifested by said output signal each time a sampling signal is provided; and

output means coupled to said storing means for providing a readable relationship of the change in temperature of said test area during the said duration of measurement when said sampling signals were provided.

10. The invention according to claim 9 wherein said system further includes a return electrode positioned to contact the skin of the subject, said return electrode being positioned within said opening between said thermal pickup means and said allergen containing means and said charging member, thermally and electrically insulated from said pickup means and electrically insulated from said charging member and said allergen containing means.

11. The invention according to claim 9 wherein said clock means includes an oscillator, a counter and a monostable multivibrator for providing said sampling signal as an enable signal to enable said storing means only during a sampling interval substantially less than a predetermined time between a sampling signal and a next succeding sampling signal.

12. The invention according to claim 11 wherein said means for storing includes microprocessor means and data memory means, said data being obtained under control of said microprocessor means and stored in said memory means.

13. The invention according to claim 12:

wherein said output signal is an analog signal having an amplitude manifesting said temperature; and

wherein said means for storing includes an analog to digital converter means responsive to said output signal and control signals from said microrocessor means for converting said output signal into a digital signal manifesting said temperature only during provision of said sampling signals.

14. The invention according to claim 13 including means for application of said digital signal to said microprocessor means and microprocessor means responsive thereto for sending, only during provision of said sampling signal, a digital signal manifesting said temperature to be stored in said memory means.

15. The invention according to claim 12 wherein said output means includes indicator means responsive to control signals from said microprocessor means for receiving said data stored in said data memory means and for providing a visual manifestation of change of temperature of said test area with respect to time.

16. A system for measuring allergic response of the skin of a subject, comprising:

a plurality of containing means for containing at least one hydrolyzable allergen in a plurality of spaced apart repository means, each said containing means having (i) a first surface adapted to contact a plurality of spaced apart areas of said skin of a subject and (ii) a second surface adapted to be contacted by a charging member;

a charging member contacting said second surface of each said allergen containing means;

means for providing an elecric charge to each said allergen whereby said allergen is transcutaneously delivered to said subject at each said area of skin;

means adapted for placement in thermal contact with said skin at each said area of skin proximate each said allergen repository means, including (a) thermal pickup means for sensing instantaneous temperature of the said skin at each said area, and (b) transducer means, in thermal communication with each said pickup means, for converting said instantaneous temperature of each said area into an output signal manifesting each said instantaneous temperature of each said area, each said thermal pickup means having an opening therein within which, thermally and electrically insulated therefrom, said allergen repository means is positioned;

clock means for providing a plurality of sampling signals each at a predetermined periodic interval related to a selected duration of measurement of temperature rate of change of an allergic response to be measured;

storing means responsive to each said area output signal and each of said sampling signals for storing data indicating the temperature manifested by each said area output signal each time a sampling signal is provided; and

output means coupled to said storing means for providing a readable relationship of the change in temperature of each said test area during the time said sampling signals are provided.

17. The invention according to claim 16 wherein said output means provides a readable relationship of the temperature of each of said test areas during each time said sampling signals are provided.

18. The invention according to claim 16 wherein said clock means includes an oscillator, a counter and a monostable multivibrator for providing said sampling signal as an enable signal to enable said storing means only during a sampling interval substantially less than a predetermined time between a sampling signal and a next succeeding sampling signal.

19. The invention according to claim 16 wherein said storing means includes microprocessor means and data memory means, said data being obtained responsive to control signals from said microprocessor means and stored in said memory means.

20. The invention according to claim 19:

wherein said output signal is an analog signal for each test area having an amplitude manifesting said temperature; and

wherein said storing means includes a multiplexer to which each of said output signals are provided, said multiplexer being controlled by said microprocessor means to provide a selected one of said output signals for storage in said data memory.

21. The invention according to claim 20 wherein said storing means further includes an analog to digital converter means responsive to said selected output signal and control signals from said microprocessor means for providing a digital signal of said selected output signal only during the provision of sampling signals.

22. The invention according to claim 21 including means for application of said digital signal to said microprocessor means and microprocessor means responsive thereto for sending, only during provision of said sampling signal, a digital signal manifesting said temperature to be stored in said memory means.

23. The invention according to claim 22 wherein said clock means includes an oscillator, a counter and a monostable multivibrator for providing said sampling signal as an enable signal to enable said storing means only during a sampling interval substantially less than a predetermined time between a sampling signal and a next succeding sampling signal.

24. The invention according to claim 21 wherein said output means includes indicator means responsive to control signals from said microprocessor means for receiving said data stored in said data memory means and for providing a visual manifestation of any change of temperature of each of said test areas with respect to time.

25. The invention according to claim 24 wherein said microprocessor means includes means for reading said converter means digital signal and storing data in said memory means related to said digital signal only during provision of said sampling signals.

26. The invention according to claim 25 wherein said clock means includes an oscillator, a counter and a monostable multivibrator for providing said sampling signal as an enable signal to enable said storing means only during a sampling interval substantially less than a predetermined time between a sampling signal and a next succeding sampling signal.

27. A method of measuring allergic response of the skin of a subject, comprising

establishing a conductive path in skin tissue of the subject between (a) a charging electrode which includes an ionizable substance to be tested for allergenicity and (b) a spaced apart electrode, thereby to transport such substance transcutaneously into skin tissue in said path;

measuring instantaneous temperature of the skin surface of said subject proximate said conductive path for a plurality of times during a predetermined period of measurement for any allergic response of the subject to the substance; and

manifesting change of skin temperature with respect to time as an indication of degree of allergic response.

28. The method according to claim 27 wherein said step of manifesting includes visually indicating a relationship of said change of skin temperature with respect to time during said period.

29. The method according to claim 27 wherein said step of measuring includes the steps of sensing the temperature of said skin surface, converting the sensed temperature into an electric signal, providing said electric signal to processor means and storing data related to said provided signal in memory means under the control of said processor means.

30. The method according to claim 29 wherein said step of manifesting includes visually indicating said change of skin temperature with respect to time relationship.

31. The method according to claim 29 wherein said step of providing said electric signal to processor means includes the step of converting said signal from an analog signal to a digital signal for storage in said memory means.

32. The method according to claim 31 wherein said step of manifesting includes visually indicating said change of skin temperature with respect to time relationship.

33. A method of measuring allergic response of the skin of a subject, comprising

establishing a conductive path in skin tissue of the subject in each of a plurality of test areas between (a) a plurality of charging electrodes each of which includes an ionizable substance to be tested for allergenicity and (b) at least one spaced apart electrode, thereby to transport each such substance transcutaneously into skin tissue in each said test area;

measuring instantaneous temperature of the skin surface of each said test area for a plurality of times during a predetermined period of measurement for allergic response of the subject to a substance in a said test area; and

manifesting change of skin temperature with respect to time of each said test area as an indication of degree of allergic response of such subject at each said test area to the substance at such test area.

34. The method according to claim 33 wherein said step of manifesting includes visually indicating a relationship of said change of skin temperature with respect to time for each test area.

35. The method according to claim 33 wherein said step of measuring includes sensing the temperature of each test area, converting each sensed temperature into an electric signal, providing each electric signal to processor means and storing data related to each provided signal in memory means under the control of said processor means.

36. The method according to claim 35 wherein said step of manifesting includes visually indicating a relationship of said change of skin temperature with respect to time for each test area.

37. The method according to claim 35 wherein said step of providing said electric signal to processor means includes selecting each of said provided signals, one at a time, and converting each selected signal from an analog signal to a digital signal, for storage in said memory means.

38. The method according to claim 37 wherein said step of manifesting includes visually indicating a relationship of skin temperature change with respect to time for each test area.

39. The method according to claim 33 wherein each said electrode includes a different substance to be delivered to each test area, whereby a plurality of different allergic reactions are tested.

40. The method according to claim 33 wherein each said electrode includes different amounts of the same substance to be delivered allergens to each to each test area, whereby the extensiveness of the allergic reaction is tested.

41. The method according to claim 33:

wherein said step of measuring includes referencing each temperature to the normal skin temperature of said patient; and

wherein said step of manifesting includes manifesting the differential rise in temperature with respect to time relationship.