US6298254B2
Expired / Lapsed
US
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Device for sampling substances using alternating polarity of iontophoretic current
Assignee: Animas Technologies LLC
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Filing: 1999-11-01
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Granted: 2001-10-02
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Expires: 2019-11-01
Abstract
Abstract A method for sampling of a substance from a subject is provided, which comprises placing one or more sampling chambers on a collection site on a tissue surface on the subject; conducting electric current through the tissue to extract a substance from the subject in a first direction in one or more sampling chambers that functions alternatively as both an anode and cathode during the course of the method; reversing the polarity to cause direct current to flow in second direction opposite the first direction; and analyzing the sampling chamber or chambers for the concentration of a substance or a substance metabolite. There is also provided a device for sampling of a substance from an organism on continuously or intermittently using alternating polarity method based on the application of low intensity electric fields of alternating polarity across the skin (iontophoresis) to enhance the transport of a substance (such as glucose, lactic acid, pyruvic acid, and the like) from body tissues to a sampling chamber. The device comprises an electrical power supply; a transdermal system that contains one or more sampling chambers that function as both anode and cathode during the course of sampling; a means to alternates or reverses the polarity during the iontophoretic sampling; and means for analyzing for the concentration of a substance or a substance metabolite.
Inventors
- 👤 Janet Tamada
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-01 13:33
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/68; A61B5/6801; A61B5/683; A61B5/6832; A61B5/6833; A61B5/145; A61B5/14532
Claims Analysis
Total Claims: 71
Claim 1
Independent Claim
124 words
A method for sampling of at least one substance from a subject which comprises: (a) conducting electrical current in a first polarity through a tissue of the subject, said conducting in a first polarity from a first sampling chamber on a surface of the tissue to a second sampling chamber on the surface of the tissue to extract a substance from the subject into the first sampling chamber; (b) conducting electrical current in a second polarity through a tissue of the subject, said conducting in a second polarity from the second sampling chamber to the first sampling chamber to extract the substance from the subject into the second sampling chamber; and (c) analyzing each sampling chamber for a concentration or amount of the substance.
Claim 2
Independent Claim
124 words
A method for sampling of at least one substance from a subject which comprises: (a) conducting electrical current in a first polarity through a tissue of the subject, said conducting in a first polarity from a first sampling chamber on a surface of the tissue to a second sampling chamber on the surface of the tissue to extract a substance from the subject into the first sampling chamber; (b) conducting electrical current in a second polarity through a tissue of the subject, said conducting in a second polarity from the second sampling chamber to the first sampling chamber to extract the substance from the subject into the second sampling chamber; and (c) analyzing each sampling chamber for a concentration or amount of the substance.
Claim 3
Dependent Claim
31 words
The method of claim 1 , wherein said conducting in a first polarity and said second conducting in a second polarity comprises reversing polarity, said reversing polarity comprises using a switch.
Claim 4
Dependent Claim
40 words
The method of claim 1 , wherein said conducting in a first polarity and said second conducting in a second polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 4 hours.
Claim 5
Dependent Claim
40 words
The method of claim 3 , wherein said conducting in a first polarity and said second conducting in a second polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 2 hours.
Claim 6
Dependent Claim
39 words
The method of claim 4 , wherein said conducting in a first polarity and said second conducting in a second polarity is performed at a frequency comprising about 1 cycle per minute to about 1 cycle per 2 hours.
Claim 7
Dependent Claim
39 words
The method of claim 5 , wherein said conducting in a first polarity and said second conducting in a second polarity is performed at a frequency comprising about 1 cycle per 10 minutes to about 1 cycle per hour.
Claim 8
Dependent Claim
32 words
The method of claim 6 , wherein said conducting in a first polarity and said second conducting in a second polarity is performed at a frequency comprising 1 cycle per half hour.
Claim 9
Dependent Claim
40 words
The method of claim 1 , wherein (i) said first sampling chamber comprises a first Ag/AgCl electrode, (ii) said second sampling chamber comprises a second Ag/AgCl electrode, and (iii) said conducting comprises conducting current between said first and second electrodes.
Claim 10
Dependent Claim
26 words
The method of claim 1 , wherein said conducting in a first polarity and said second conducting in a second polarity comprises an alternating polarity current.
Claim 11
Dependent Claim
14 words
The method of claim 9 , wherein said alternating polarity current is applied continuously.
Claim 12
Dependent Claim
14 words
The method of claim 9 , wherein the alternating polarity current is applied intermittently.
Claim 13
Dependent Claim
17 words
The method of claim 1 , wherein said surface of the tissue is a stratum corneum surface.
Claim 14
Dependent Claim
23 words
The method of claim 1 , wherein said first and second sampling chamber each comprise electrodes that are integral with the sampling chamber.
Claim 15
Dependent Claim
14 words
The method of claim 1 , wherein each sampling chamber comprises a collection medium.
Claim 16
Dependent Claim
17 words
The method of claim 14 , wherein said conducting comprises applying electrical energy to the collection medium.
Claim 17
Dependent Claim
11 words
The method of claim 1 , wherein said conducting comprises iontophoresis.
Claim 18
Dependent Claim
28 words
The method of claim 1 , wherein the step of conducting electrical current comprises applying a current density in the range of 0.01 to 2 mA/cm 2 .
Claim 19
Dependent Claim
26 words
The method of claim 1 , wherein the step of conducting electrical current comprises the step of ceasing the conducting electrical current during the analyzing step.
Claim 20
Dependent Claim
13 words
The method of claim 1 , wherein the analyzing step is performed periodically.
Claim 21
Dependent Claim
19 words
The method of claim 1 , wherein the analyzing step comprises the step of using high performance liquid chromatography.
Claim 22
Dependent Claim
34 words
The method of claim 1 , wherein the sampling chamber contains a collection medium, the analyzing step comprising the step of extracting at least a portion of the collection medium from the sampling chamber.
Claim 23
Dependent Claim
21 words
The method of claim 1 , further comprising (d) correlating the concentration determined in step (c) with a blood substance level.
Claim 24
Dependent Claim
25 words
The method of claim 1 , further comprising the step of (d) providing correlation data between a sampling chamber substance level and blood substance levels.
Claim 25
Dependent Claim
25 words
The method of claim 1 , further comprising (d) a correlating step that comprises calculating substance flux from the collection site into the sampling chamber.
Claim 26
Dependent Claim
24 words
The method of claim 24 , wherein the correlating step also comprises compensating for time lag between blood substance level values and substance flux.
Claim 27
Dependent Claim
18 words
The method of claim 24 , wherein the correlating step also comprises compensating for substance flux value drift.
Claim 28
Dependent Claim
20 words
The method of claim 1 , wherein the steps are performed repeatedly for about 2 hours to about 72 hours.
Claim 29
Dependent Claim
21 words
The method of claim 1 , further comprising the step of treating the patient in response to the substance level determined.
Claim 30
Dependent Claim
11 words
The method of claim 1 , wherein said substance is glucose.
Claim 31
Dependent Claim
14 words
The method of claim 1 , wherein more than one substance is being sampled.
Claim 32
Dependent Claim
27 words
The method of claim 1 , wherein said analyzing further comprises analyzing each sampling chamber for a concentration or amount of the substance or a substance metabolite.
Claim 33
Dependent Claim
13 words
The method of claim 1 , wherein said analyzing comprises pulsed amperometric detection.
Claim 34
Independent Claim
170 words
A method for sampling of glucose from a subject, said method comprising (a) conducting electrical current in a first polarity through a tissue of the subject, said conducting in a first polarity from a first sampling chamber on a surface of the tissue to a second sampling chamber on the surface of the tissue to extract the glucose from the subject into the first sampling chamber, wherein (i) each sampling chamber comprises a collection medium, (ii) said conducting comprises applying electrical energy to the collection medium; and (iii) said conducting and extracting comprises iontophoresis; (b) conducting electrical current in a second polarity through a tissue of the subject, said conducting in a second polarity from the second sampling chamber to the first sampling chamber, to extract the glucose from the subject into the second sampling chamber, wherein (i) said conducting comprises applying electrical energy to the collection medium; and (ii) said conducting and extracting comprises iontophoresis; and (c) analyzing each sampling chamber for a concentration or amount of the glucose.
Claim 35
Independent Claim
170 words
A method for sampling of glucose from a subject, said method comprising (a) conducting electrical current in a first polarity through a tissue of the subject, said conducting in a first polarity from a first sampling chamber on a surface of the tissue to a second sampling chamber on the surface of the tissue to extract the glucose from the subject into the first sampling chamber, wherein (i) each sampling chamber comprises a collection medium, (ii) said conducting comprises applying electrical energy to the collection medium; and (iii) said conducting and extracting comprises iontophoresis; (b) conducting electrical current in a second polarity through a tissue of the subject, said conducting in a second polarity from the second sampling chamber to the first sampling chamber, to extract the glucose from the subject into the second sampling chamber, wherein (i) said conducting comprises applying electrical energy to the collection medium; and (ii) said conducting and extracting comprises iontophoresis; and (c) analyzing each sampling chamber for a concentration or amount of the glucose.
Claim 36
Dependent Claim
21 words
The method of claim 33 , further comprising (d) correlating the concentration determined in step (c) with a blood glucose level.
Claim 37
Dependent Claim
22 words
The method of claim 33 , further comprising (d) providing correlation data between sampling chamber glucose levels and the subject's glucose levels.
Claim 38
Dependent Claim
34 words
The method of claim 33 , wherein said conducting in a first polarity and said second conducting in a second polarity comprises an alternating polarity current and said alternating polarity current is applied intermittently.
Claim 39
Dependent Claim
13 words
The method of claim 33 , wherein said analyzing comprises pulsed amperometric detection.
Claim 40
Dependent Claim
80 words
An iontophoresis sampling device comprising (a) a transdermal system that comprises (i) a first sampling chamber for receiving a sample, wherein the first sampling chamber comprises a first electrode that is connectable with an electrical power supply, and (ii) at least a second electrode that is connectable with said power supply; and (b) means for reversing polarity between the first electrode and the second electrode, wherein the first electrode functions as both an anode and a cathode during iontophoretic sampling.
Claim 41
Dependent Claim
80 words
An iontophoresis sampling device comprising (a) a transdermal system that comprises (i) a first sampling chamber for receiving a sample, wherein the first sampling chamber comprises a first electrode that is connectable with an electrical power supply, and (ii) at least a second electrode that is connectable with said power supply; and (b) means for reversing polarity between the first electrode and the second electrode, wherein the first electrode functions as both an anode and a cathode during iontophoretic sampling.
Claim 42
Dependent Claim
19 words
The device of claim 38 , wherein said second electrode comprises an indifferent counter electrode that also alternates polarity.
Claim 43
Dependent Claim
40 words
The device of claim 38 , wherein said transdermal system further comprises a second sampling chamber, said second sampling chamber comprising said second electrode, wherein said second electrode alternates function as both an anode and a cathode during iontophoretic sampling.
Claim 44
Dependent Claim
31 words
The device of claim 40 , further comprising (c) means for analyzing a concentration or amount of a substance or a substance metabolite received in the first and second sampling chambers.
Claim 45
Dependent Claim
27 words
The device of claim 41 , further comprising (d) a programmed processor for correlating the concentration or amount determined in step (c) with a blood substance level.
Claim 46
Dependent Claim
26 words
The device of claim 41 , further comprising (d) a programmed processor for providing correlation data between a sampling chamber substance level and blood substance levels.
Claim 47
Dependent Claim
13 words
The device of claim 41 , wherein said analyzing comprises pulsed amperometric detection.
Claim 48
Dependent Claim
14 words
The device of claim 40 , wherein each sampling chamber comprises an Ag/AgCl electrode.
Claim 49
Dependent Claim
14 words
The device of claim 45 , wherein each sampling chamber comprises a collection medium.
Claim 50
Dependent Claim
29 words
The device of claim 38 , further comprising (c) means for analyzing a concentration or amount of a substance or a substance metabolite received in the first sampling chamber.
Claim 51
Dependent Claim
13 words
The device of claim 47 , wherein said analyzing comprises pulsed amperometric detection.
Claim 52
Dependent Claim
30 words
The device of claim 38 , wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 4 hours.
Claim 53
Dependent Claim
30 words
The device of claim 49 , wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 2 hours.
Claim 54
Dependent Claim
29 words
The device of claim 50 , wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per minute to about 1 cycle per 2 hours.
Claim 55
Dependent Claim
29 words
The device of claim 51 , wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per 10 minutes to about 1 cycle per hour.
Claim 56
Dependent Claim
23 words
The device of claim 52 , wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per half hour.
Claim 57
Dependent Claim
15 words
The device of claim 38 , wherein the first sampling chamber comprises an Ag/AgCl electrode.
Claim 58
Dependent Claim
15 words
The device of claim 54 , wherein the first sampling chamber comprises a collection medium.
Claim 59
Dependent Claim
15 words
The device of claim 38 , wherein said means for reversing polarity comprises a switch.
Claim 60
Dependent Claim
12 words
The device of claim 38 , further comprising an electrical power supply.
Claim 61
Dependent Claim
11 words
The device of claim 38 , wherein said sample comprises glucose.
Claim 62
Dependent Claim
14 words
The device of claim 38 , wherein said sample comprises more than one substance.
Claim 63
Dependent Claim
109 words
An iontophoresis device for sampling glucose, said device comprising (a) a transdermal system that comprises (i) a first sampling chamber for receiving a sample, wherein the first sampling chamber comprises a first electrode that is connectable with an electrical power supply and a collection medium, and (ii) a second sampling chamber for receiving a sample, wherein the second sampling chamber comprises a second electrode that is connectable with an electrical power supply and a collection medium; and (b) means for reversing polarity between the first electrode and the second electrode, wherein the first and second electrodes each alternately function as both an anode and a cathode during iontophoretic sampling.
Claim 64
Dependent Claim
109 words
An iontophoresis device for sampling glucose, said device comprising (a) a transdermal system that comprises (i) a first sampling chamber for receiving a sample, wherein the first sampling chamber comprises a first electrode that is connectable with an electrical power supply and a collection medium, and (ii) a second sampling chamber for receiving a sample, wherein the second sampling chamber comprises a second electrode that is connectable with an electrical power supply and a collection medium; and (b) means for reversing polarity between the first electrode and the second electrode, wherein the first and second electrodes each alternately function as both an anode and a cathode during iontophoretic sampling.
Claim 65
Dependent Claim
14 words
The device of claim 60 , wherein said first and second electrodes comprise Ag/AgCl.
Claim 66
Dependent Claim
26 words
The device of claim 60 , further comprising (c) means for analyzing a concentration or amount of glucose received in the first and second sampling chambers.
Claim 67
Dependent Claim
27 words
The device of claim 62 , further comprising (d) a programmed processor for correlating the concentration or amount determined in step (c) with a blood glucose level.
Claim 68
Dependent Claim
26 words
The device of claim 62 , further comprising (d) a programmed processor for providing correlation data between a sampling chamber glucose level and blood glucose level.
Claim 69
Dependent Claim
13 words
The device of claim 62 , wherein said analyzing comprises pulsed amperometric detection.
Claim 70
Dependent Claim
12 words
The device of claim 60 , further comprising an electrical power supply.
Claim 71
Dependent Claim
24 words
The device of claim 60 , wherein said reversing of polarity comprises an alternating polarity current and said alternating polarity current is applied intermittently.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2004-10-01 | 2005-04-02 | 2005-10-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2008-10-01 | 2009-04-02 | 2009-10-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2012-10-01 | 2013-04-02 | 2013-10-02 | $7700.00 | Window Closed / Lapsed |