Method and system for continuous sweat collection and analysis

• US 6,198,953 B1
• Filed: 03/11/1999
• Issued: 03/06/2001
• Est. Priority Date: 03/11/1999
• Status: Expired due to Term

• Current Assignee: Wesco Incorporated (HF HOLDINGS INC)
• Original Assignee: Wesco Incorporated (HF HOLDINGS INC)
• Inventors: Quirante, Carmelo G., Briscoe, Dennis R., Thomas, Scot B., Webster, Henry L., Barlow, Wayne K.
• Primary Examiner(s): Nasser, Robert L.
• Application Number:
  US09/266,532
• Time in Patent Office: 726 Days
• Field of Search: 600/345, 600/346
• US Class Current: 600/345
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

The method and system of the invention provide especially for continuously obtaining and analyzing, on a real time basis, sweat from a selected area of skin on the body of a person, especially a neonate, being diagnosed for cystic fibrosis, by causing sweating of the selected area of skin, by placing an electrically positive iontophoretic electrode device of a set of said devices over the selected area of skin preferably within a previously placed receiving and holding device which, following the induction of sweat and removal of the electrically positive iontophoretic electrode device, receives a sweat-sensing electrode device that continuously sends electrical signals to sweat analysis circuitry for providing a digital readout of the ionic composition of the sweat. The receiving and holding device insures recovery and utilization of essentially all of the sweat being produced by the selected area of skin. The sweat-sensing electrode device is of unique construction with respect to the flow of recovered sweat relative to ion-sensing electrodes arranged preferably serially along the path of sweat flow through the body of the sweat-sensing electrode device. The invention is not restricted to the foregoing use, but may be used in whole or in part to analyze sweat on a real time basis however produced and collected, with or without timing of its travel between sequential electrodes and use of the travel time to calculate the rate of sweating within the selected area of skin.

Claims

1. A method for obtaining and analyzing sweat from a selected area of a person'"'"'s skin in the substantial absence of air, comprising causing said area of skin to sweat;

recovering the sweat from said area of skin substantially continuously as it is produced by flowing it substantially continuously as an elongate and relatively narrow stream into and through electrical ion-sensing means to discharge exteriorly thereof; and

electrically monitoring said ion-sensing means substantially continuously to produce electrical output signals indicative of variations in the ion concentration of said stream of flowing sweat on a real-time basis.

2. A method according to claim 1, wherein the step of monitoring the ion-sensing means comprises measuring electrical conductivity of the recovered sweat.

3. A method according to claim 1, wherein the step of monitoring the ion-sensing means comprises sensing the concentration of a particular species of ion in the sweat.

4. A method according to claim 1, further comprising using the electrical output signals to produce an information display indicative of the condition of the person with respect to the presence or absence of cystic fibrosis.

5. A method according to claim 1, wherein the area of skin is caused to sweat by a set of positive and negative iontophoretic electrode devices;

placing the positive one of which devices over the said area of skin and operating it; and

recovering the resulting sweat substantially continuously by replacing the positive iontophoretic electrode device with a sweat-sensing electrode device containing said ion-sensing means.

6. A method according to claim 5, wherein the sweat-sensing electrode device is a body having a concave sweat-recovering surface and an elongate and relatively narrow passage extending through said body from a sweat-entry end at the apex of said sweat-recovering surface to a discharge end for sweat;

and wherein the ion-sensing means comprises electrical ion-measuring electrodes positioned serially along said passage in communication therewith.

7. A method according to claim 5, wherein is included the step of securing a receving and holding device over the area of skin for sequentially receiving and holding, first, the electrically positive, iontophoretic electrode device and, then, the sweat-sensing electrode device in sequentially the same registry with said area of skin;

sequentially mounting and seuring, first, the electrically positive, iontophoretic electrode device and, then, the sweat-sensing electrode device in said receiving and holding device; and

sequentially operating the respective electrode devices.

8. A method according to claim 7, wherein the receiving and holding device and the electrode devices themselves are provided with interlatching members for holding said electrode devices in place in said receiving and holding device;

and sequentially placing the respective electrode devices in and interlatching them with said receiving and holding device.

18. A system according to claim 8, wherein the sweat-sensing electrode device comprises a body member having a concave sweat-recovering surface and an elongate and relatively narrow passage leading through said body member from the apex of said sweat-recovering surface to a discharge passage for sweat;

and wherein the sweat-sensing electrode device comprises electrical conductivity measuring electrodes positioned serially in communication with said passage.

19. A system according to claim 18, wherein is included an electrical outlet plug device adapted to be plugged into the body member of the sweat-sensing electrode device in electrical contact with the electrodes thereof.

9. A method for obtaining and analyzing sweat from a selected area of a person'"'"'s skin, comprising causing said area of skin to sweat;

recovering the sweat from said area of skin substantially continuously;

flowing the recovered sweat substantially continuously through electrical ion-sensing means; and

electrically monitoring said ion-sensing means substantially continuously to produce electrical signals indicative of variations in ion concentration of the flowing sweat on a real-time basis, wherein the electrical signals indicative of variations in the flowing sweat are monitored by analyzing means, which are electrically associated with electrical control means for sweat induction in respective circuit portions of microprocessor circuitry in common, which circuitry has a manually operated microprocessor; and

operating said microprocessor to activate the respective circuit portions sequentially to proved a first electrical output and a second electrical output;

sending said first electrical output form the sweat induction circuit portion to said electrical control means for regulating the strength of sweat induction; and

sending said second electrical output form the other circuit portion to said ion-sensing means for analyzing the recovered sweat from said area of the person'"'"'s skin.

10. A method according to claim 9, wherein the ion-sensing means comprise a pair of electrically conductive, sensing electrodes serially spaced apart along and in communication with the path of flow of the recovered sweat;

wherein the sensing electrodes are monitored by measuring the time of flow of the flowing sweat between a sensing electrode of said pair and the subsequent sensing electrode of said pair; and

using the measurements so obtained, along with the known volume of sweat flowing between the electrodes and the known size of the selected area of skin to obtain the rate of sweating by the person.

11. A system for obtaining and analyzing sweat from a selected area of a person'"'"'s skin in the substantial absence of air, comprising iontophoretic means for causing a selected area of skin of the person to sweat;

means for recovering sweat from said selected area of skin substantially continuously as produced by the sweat glands of said area of skin, which sweat-recovery means comprises a body member having an elongate and relatively narrow passage with an entry end and a discharge end;

electrical ion-sensing means confronting the interior of said passage for contact by the recovered sweat as it flows as a substantially continuous stream through said passage past and in contact with said ion-sensing means to produce electrical signals indicative of variations in the ion concentration of the flowing sweat on a real-time basis.

12. A system according to claim 11, wherein are included means for using the resulting electrical signals to provide information indicative of the condition of the person with respect to the presence or absence of cystic fibrosis.

13. A system according to claim 11, wherein the electrical ion-sensing means are electrical conductivity sensing electrodes.

14. A system according to claim 11, wherein the electrical ion-sensing means comprises at least one electrochemical sensor producing electrical signals in proportion to the concentration of a particular species of ion in the sweat.

15. A system according to claim 11, wherein the means for causing a selected area of skin on the body of a person to sweat comprises an electrically positive, iontophoretic, drug-carrying, electrode device and an electrically negative, electrode device for completing an iontophoretic electrical circuit;

and wherein the means for recovering sweat from the said selected area of skin substantially continuously, the ion-sensing electrode means, and the means for flowing the recovered sweat substantially continuously through said ion-sensing means are provided by a sweat-sensing electrode device.

16. A system according to claim 15, wherein is included a device for sequentially receiving and holding the electrically positive iontophoretic, drug-carrying electrode device and the sweat-sensing electrode device in substantially the same registry with the selected area of skin.

17. A system according to claim 15, wherein the receiving and holding device and the electrode devices themselves are provided with interlatching members for holding said electrode devices in place over the selected area of skin.

20. A method for the continuous recovery and analysis of sweat from a person, comprising sealingly applying against the absence of air to a selected area of skin of the person a sweat-sensing electrode device having a body member with an exterior surface adapted to cover said selected area of skin and with an elongate and relatively narrow passage having a sweat-receiving end opening into said exterior surface for receiving sweat therefrom substantially immediately as it is produced by the sweat glands of said area of skin to provide a substantially continuously flowing, elongate and relatively narrow stream of sweat, there being at least a pair of electrodes with sweat-sensing ends confronting the interior of said passage and arranged serially along said passage so the received sweat flowing in and through said passage as a substantially continuous stream will pass from electrode to electrode between and in contact therewith providing electrical output from which is obtained an ion concentration verses time profile that varies as freshly produced sweat is added to the flowing stream;

and using the electrical output from said electrodes substantially continually to present said profile on a real-time basis.

21. A system for the continuous recovery and analysis of sweat from a selected area of skin of a person in the substantial absence of air, comprising a sweat-sensing device with a body member having an exterior surface adapted to sealingly cover the selected area of skin and having an elongate and relatively narrow passage with a sweat entry end opening into said exterior surface for receiving sweat therefrom substantially immediately as it is produced by the sweat glands of said area of skin to provide a substantially continuously flowing, elongate and relatively narrow stream of sweat, there being at least a pair of electrodes with sweat-sensing ends confronting the interior of said passage and arranged serially along said passage so the received sweat flowing in and through said passage as a substantially continuous stream will pass from electrode to electrode between and in contact therewith providing electrical output from which is obtained an ion concentration verses time profile that varies as freshly produced sweat is added to the flowing stream;

and means for analyzing the electrical output from said electrodes substantially continually to present said profile on a real-time basis.

22. A system for attachment to the body of a person to obtain and analyze sweat from a selected area of the skin of said person in the substantial absence of air, comprising iontophoretic means for causing said selected area of skin to sweat;

means for directing the sweat, that emerges substantially continuously under hydraulic pressure from the seat glands of said selected area of skin, into the entry end of an elongate and relatively narrow passage which has a discharge end and electrical ion-sensing means confronting the inside of such flow passage, so the sweat will flow through said passage in contact with said electrical ion-sensing means; and

means for using electrical signals from said ion-sensing means to provide, on a substantially continuous basis during said sweat production, diagnostic information indicative of the condition of the person with regard to the presence or absence of cystic fibrosis.

23. A method for determining the rate of sweating of a living body comprising causing, in the substantial absence of air, a selected area of a person'"'"'s skin to sweat, recovering the sweat from said area as it is produced by flowing it substantially continuously as an elongate and relatively narrow stream into and through electrical sensing means to discharge exteriorly thereof, and electrically monitoring said ion sensing means substantially continuously to produce electrical output signals indicative of the rate of sweating of said area, and determining the rate of sweating from said signals.