System, method, and device for non-invasive body fluid sampling and analysis
First Claim
1. A method for non-invasive body fluid sampling and analysis, comprising:
- identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane by applying ultrasound having a frequency range of from about 10 kHz to about 500 kHz to the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least one analyte;
continuously analyzing the at least one analyte; and
providing the results of the step of continuously analyzing the at least one analyte.
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Accused Products
Abstract
A system, method, and device for non-invasive body fluid sampling is provided. According to one embodiment of the present invention, the system includes a controller that controls the generation of ultrasound; an ultrasonic applicator that applies the ultrasound to an area of biological membrane; a receiver that contacts the area of biological membrane and receives body fluid through and out of the area of biological membrane; and a meter that interacts with the receiver and detects the presence of at least one analyte in the body fluid in the receiver. The receiver may include a membrane and a medium, such as a hydrogel, a fluid, or a liquid, that is contained in the membrane. According to one embodiment of the present invention, the method includes the steps of (1) identifying an area of biological membrane having a permeability level; (2) increasing the permeability level of the area of biological membrane; (3) contacting the area of biological membrane with a receiver; (4) extracting body fluid through and out of the area of biological membrane; (5) providing an external force to enhance the body fluid extraction; (6) collecting the body fluid in the receiver; (7) analyzing the collected body fluid for the presence of at least one analyte; and (8) providing the results of the step of analyzing the body fluid.
394 Citations
68 Claims
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1. A method for non-invasive body fluid sampling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane by applying ultrasound having a frequency range of from about 10 kHz to about 500 kHz to the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least one analyte;
continuously analyzing the at least one analyte; and
providing the results of the step of continuously analyzing the at least one analyte. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for non-invasive body fluid sampling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least ne analyte;
analyzing the at least one analyte; and
providing the results of the step of analyzing the at least one analyte;
wherein the step of identifying an area of biological membrane having a permeability level comprises;
providing a target identifying device to the area of biological membrane.
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15. A method for non-invasive body fluid sampling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least one analyte;
analyzing the at least one analyte;
providing the results of the step of analyzing the at least one analyte;
providing the receiver with a second receiver, the second receiver having a concentration of the at least one analyte; and
maintaining the concentration of the at least one analyte in the second receiver at a level that is lower than a concentration of the extracted at least one analyte. - View Dependent Claims (16, 17)
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18. A method for non-invasive body fluid sampling and analysis,
comprising: -
identifying an area of biological membrane having a permeability level;
increasing the permeabiligy level of the area of biologial membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of area of biological membrane and into the receiver;
providing a first external force by generating at least one osmotic force to enhance the extraction of the at least one analyte;
analyzing the at least one analyte; and
providing the results of the step of analyzing the at least one analyte;
wherein the step of generating at least one osmotic force to enhance the extraction of the at least one analyte comprises;
regulating the at least one osmotic force with a second external force selected from the group consisting of heat, a temperature force, a pressure force, an electromotive force, mechanical agitation, ultrasound, iontophoresis, an electromagnetic force, a magnetic force, a photothermal force, a photoacoustic force, and combinations thereof.
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19. A method for non-invasive body fluid sampling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing a first external force by generating at least one osmotic force to enhance the extraction of the at least one analyte;
analyzing the at least one analyte; and
providing the results of the step of analyzing the at least one analyte;
wherein the step of generating at least one osmotic force to enhance the extraction of the at least one analyte comprises;
manipulating at least one of an intensity of the at least one osmotic force, a duration of the at least one osmotic force, and a frequency of the at least one osmotic force with a second external force. - View Dependent Claims (20)
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21. A method for non-invasive body fluid samling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least one analyte;
analyzing the at least one analyte; and
providing the results of the step of analyzing the at least one analyte;
wherein the step of analyzing the at least one analyte comprises;
determining an analyte flux for the at least one analyte from the body fluid based on an analyte flux for a plurality of analytes from the body fluid.
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22. A method for non-invasive body fluid sampling and analysis, comprising:
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identifying an area of biological membrane having a permeability level;
increasing the permeability level of the area of biological membrane;
contacting the area of biological membrane with a receiver;
extracting at least one analyte of the body fluid through and out of the area of biological membrane and into the receiver;
providing an external force to enhance the extraction of the at least one analyte;
analyzing the at least one analyte; and
providing the results of the step of analyzing the at least one analyte; and
removing the receiver from the area of biological membrane after a predetermined condition. - View Dependent Claims (23, 24, 25, 26)
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27. A system for non-invasive body fluid sampling and analysis comprising:
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a device for measuring a permeability level of an area of biological membrane;
an ultrasonic applicator that applies the ultrasound to the area of biological membrane;
a controller that controls the generation of ultrasound in response to permeability measurements;
a receiver that contacts the area of biological membrane and receivers at least one analyte of the body fluid through and out the area of biological membrane, the receiver comprising;
a medium; and
a meter that interacts with thge receiver and detects the analyte flux for the at least one analyte entering the receiver. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38)
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39. A system for non-invasive body fluid sampling and analysis comprising:
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a controller that controls the generation of ultrasound;
an ultrasonic applicator that applies the ultrasound to an area of biological membrane;
a receiver that contracts the area of biological membrane and receives at least one analyte of the body fluid through and out of the area biological membrane, the receiver comprising;
a medium; and
a meter that interacts with the receiver and detects analyte flux for the at least one analyte entering the receiver;
a device that provides a first additional energy/force to the area of biological membrane, and a second receiver in communication with the receiver and having a concentration of the at least one analyte;
wherein the concentration of the at least one analyte in the second receiver is maintained at a level that is lover than a concentration of the at least one analyte received in the receiver. - View Dependent Claims (40, 41)
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42. A method for noninvasive body fluid sampling and analysis, comprising:
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enhancing a permeability level of an area of biological membrane;
attaching a receiver to the area of biological membrane;
extracting at least one analyte through and out of the area biological membrane;
receiving the at least one analyte in the receiver; and
determining a flux of at least one analyte from the body fluid, based on the flux of a plurality of analaytes from the body fluid. - View Dependent Claims (43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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54. A device for noninvasive body fluid sampling and analysis, comprising:
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a receiver that is adapted to be attached to an area of biological membrane with an enhanced permeability and adapted to receiver at least one analyte through and out of the area of biological membrane, the receiver comprising;
a medium; and
a wearable meter that measures the flux of the at least one analyte in a continuous manner, the wearable meter comprising;
a processor; and
a device that detects the flux of the analyte selected from the group consisting of;
an electrochemcial detector, a biochemical detector;
a fluorescence detector, a absorbance detector, a reflectance detector, a Raman detector;
a magnetic detector;
a mass spectrometry detector, IR spectroscopy detector; and
combinations thereof. - View Dependent Claims (55, 56, 57, 58, 59)
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60. A receiver that is adapted to be attached to an area of biological membrane with an enhanced permeability and adapted to receive at least one analyte through and out of the area of biological membrane, the receiver comprising:
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a first grid;
a medium layer comprising at least one agent;
a membrane that induces a concentration gradient barrier for the at least one agent;
a counter grid;
an oxidase layer;
a detection layer; and
a voltage source that provides a potential difference between the first grid and the counter grid;
wherein the at least one analyte flows out of or through the biological membrane to the detector layer via the first grid, the counter grid, and the oxidase layer. - View Dependent Claims (61, 62, 63, 64, 65, 66)
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67. A method for non-invasive body fluid sampling and analysis, comprising:
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a) identifying an area of biological membrane having a permeability level;
b) increasing the permeability level of said area by applying low frequency ultrasound;
c) providing a transport force to said area to extract an analyte from a body fluid through said area into a sensing zone in communication therewith; and
d) continuously analyzing said analyte in said sensing zone. - View Dependent Claims (68)
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Specification