Electrode for non-invasive allergy testing

• US 4,809,707 A
• Filed: 04/12/1985
• Issued: 03/07/1989
• Est. Priority Date: 04/12/1985
• Status: Expired due to Fees

• Current Assignee: KVM Engineering, Inc.
• Original Assignee: KVM Engineering, Inc.
• Inventors: Johnson, Corrine, Vick, Howard A., Meador, James W., Kraft, Thomas L.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): SHAY, DAVID M
• Application Number:
  US06/722,772
• Time in Patent Office: 1,425 Days
• Field of Search: 128/736, 128/743, 128/664, 128/640, 128/798, 128/803, 128/419 R, 604/20
• 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 electrode for performing a plurality of allergy tests on a patient undergoing tests. The allergy electrode consists of a plurality of individual testing electrodes and a single common electrode. Each of the testing electrodes includes allergen delivery apparatus and a temperature sensor. The allergen is contained in a removable allergen impregnated pad. If a dry allergen is used, it may be hydrolized with a drop of distilled water prior to application. A small electric charge charges a charge plate on one side of the allergen pad and a common ring on the electrodes is grounded in circuit with the charging plate, thereby causing electric field to transfer the allergen through the pores of the skin. The area surrounding the allergen delivery area is sensed for temperature by a thin film temperature sensor and a rigid temperature conducted base. A thermistor or other temperature to voltage transducer converts the sensed temperature to an electric voltage which is applied through appropriate differential amplifiers and multiplexer to an analog to digital converter. The digital data is then stored by a microprocessor in random access memory. An output device can be connected to receive the stored data and the time at which it was stored so as to manifest to the physician the change in temperature of the tested area with respect to time.

Claims

1. An allergy testing system comprising:

means for containing a hydrolyzed allergen, such means having opposed first and second surfaces, said first surface being adapted to contact an area of skin of a person being tested;

a charge plate contacting said second surface of said allergen containing means;

means for providing an electric charge produced from an electric current of between 1 and 4 milliamperes to said allergen, whereby said allergen is transcutaneously delivered into said area of skin; and

means effectively positioned for detecting the temperature of said area of skin proximate said allergen containing means and for outputting an electric signal indicative of said temperature.

2. The invention according to claim 1 wherein said allergen containing means is removeable from said system.

3. The invention according to claim 2 wherein said allergen containing means is porous.

4. The invention according to claim 1 wherein said system further includes a return electrode positioned to contact the skin of said patient, said return electrode having an opening therein in which said allergen containing means and said charge plate are positioned, said charge plate and allergen containing means being electrically insulated from said return electrode.

5. The invention according to claim 4 wherein said return electrode is coupled serially in circuit with said patient, said allergen containing means and said charge plate, and through which circuit said current flows.

6. The invention according to claim 5 wherein said allergen containing means is removable from said system.

7. The invention according to claim 6 wherein said allergen containing means is porous.

8. An allergic response testing device for skin, including:

iontophoretic allergen delivery means for transcutaneously delivering a selected substance into the skin of a person to test for allergic response of the person to said substance, said means including charging and return electrodes positioned for spaced topical placement on the skin effective to provide a conductive iontophoretic path through the tissue of the skin, said charging electrode including a charging member and in electrical communication therewith 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; and

temperature sensing and signaling means coupled with said allergen delivery means and positioned for placement in thermal contact with said skin at an area in juxtaposition to said path, for sensing skin temperatures in said area after initiation of said transcutaneous substance delivery and for outputting electric signals indicative of such temperatures.

9. The device of claim 8 in which said temperature sensing and signaling means includes thermal pickup means for sensing the temperature of the said area of skin and transducer means in thermal communication with said pickup means for converting said communicated sensed temperature into an electrical output signal.

10. The device of claim 9 in which said transducer means is a thermister.

11. The device of claim 9 including a base, said allergy delivery means and said temperature sensing and signaling means being insulatively affixed to said base, said pickup means being laterally disposed to one of said electrodes.

12. The device of claim 9 in which said pickup means surrounds said allergy delivery means.

13. The device of claim 9 in which said charging and return electrodes respectively include charging and return electric lead means for delivery respectively of charging current and return current, and wherein said temperature sensing and signaling means includes signaling electric lead means for delivering said output electric signal.

14. The device of claim 9 in which said medium is a replaceable pad.

15. The invention of claim 9 further including a second thermal pickup means and a second transducer means positioned remote from said thermal pickup means and transducer means and from skin effects caused by the delivery of said allergen by said allergen delivery means, to provide a signal manifesting a normal temperature of said skin of said person.

16. The invention according to claim 9 further including a plurality of associated thermal pickup means, transducer means and allergen delivery means.

17. The invention according to claim 16 further including normal temperature measuring means positioned to be remote from the skin effects caused by the delivery of said allergen by said allergen delivery means.

18. The invention according to claim 17 further including means to removably affix said device to said skin.

19. The invention according to claim 13 in which said temperature sensing and signaling means includes thermal pickup means for sensing the said temperature and a thermister in thermal communication with said pickup means, said thermal pickup means surrounding said allergen containing means.

20. A device for performing a plurality of allergy tests on the skin of a person under test comprising:

a plurality of testing means each including;

a temperature pickup and signal providing means having an opening therethrough adapted to be placed in contact with the skin of said person, said pickup and signal providing means providing an electric signal manifesting the temperature of said skin contacting said pickup and signal providing means, and

allergen delivery means positioned through said opening for transcutaneously delivering said allergen to said patient, said delivery means including electrode means across which voltage may be impressed to generate an electric field and allergen containing means positioned to be in the generated electric field and adapted to contact said skin;

common temperature sensing means, adapted to be placed in contact with said skin in an area remote from any reaction caused by the transcutaneous delivery of said allergen to said patient, for providing an electric signal manifesting the normal temperature of said skin; and

lead means coupled to each of said testing means and said common means for providing an electric charge to said electrode means and for receiving said signal from said pickup and signal providing means and said common means.

21. The invention according to claim 20 wherein said allergen delivery means includes an allergen impregnated pad having opposed first and second surfaces, said first surface being positioned to contact said skin;

a charge plate contacting said second surface of said pad; and

a return electrode electrically insulated from said charge plate and said pad and positioned to contact said skin, each of said charge plate, pad and return electrode being within said opening.

22. The invention according to claim 20 wherein said device further includes a housing material containing each of said testing means, said common means and said lead means, said housing material being a temperature and electrical insulating material.

23. The invention according to claim 20 wherein each of said temperature pickup and signal providing means includes a temperature conductive ring and a temperature to electric signal transducer means thermally coupled to said ring.

24. The invention according to claim 23 wherein said transducer means is a thermistor.

25. The invention according to claim 23 wherein said ring is a thin film member affixed to a rigid temperature conductive base.

26. The invention according to claim 25 wherein said transducer means is thermally bonded to said base.

27. The invention according to claim 26 wherein said transducer means is a thermistor.

28. A method of testing for, and signaling indicia of, an allergic response manifested at the skin of a person, comprising

(a) establishing and completing a conductive path in skin tissue between a charging electrode, which includes a substance to be tested for allergenicity, and a spaced apart return electrode, thereby to deliver such substance iontophoretically into the skin tissue;

and

(b) detecting the temperature of the skin proximate said path and outputting an electric signal indicative of said temperature.

29. The method of claim 28 in which step (a) is cyclically performed in repetitions of predetermined duration and step (b) is performed between each cycle of step (a).

30. A method of allergy testing, comprising:

placing a hydrolyzed allergen containing member in contact with an area of skin of a person being tested;

providing an electromotive-force to said member;

discontinuing said electro-motive force;

sensing the temperatures of the skin of the person proximate said member after said electromotive force is discontinued during a period of time effective for sensing the rate and extent of temperature rise in said skin in an allergic response of the person to said allergen;

transducing said sensed temperatures during said period to electric output indicia of said temperatures; and

signaling said electric output indicia during said period.

31. The method of claim 30 in which the steps of providing and discontinuing are cyclically performed in repetitions of predetermined duration of providing and the steps of sensing, transducing and signaling are performed between each of said steps of providing and discontinuing.

32. The method of claim 30 wherein said allergen containing member includes a first surface for contacting said skin of a person being tested and an opposed second surface for contacting a charge plate, and said step of providing includes positioning a charge plate on said second surface of said member and applying an electro-motive force to said charge plate.

33. The method according to claim 32 wherein said electro-motive force is applied by providing an electric current between 1.0 and 4.0 milliamperes to said charge plate.

34. The method according to claim 37 wherein said method includes utilizing an electrode having a permanent charge plate and a replaceable member, said method further including placing a new member in said electrode and attaching said electrode to said patient'"'"'s skin for each test.