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  System and method for analyte sampling and analysisUSPTO Application #: 20060094945Title: System and method for analyte sampling and analysis Abstract: The invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane and an electrode assembly comprising a plurality of electrodes, wherein the medium is adapted to react continuously with the analyte, an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. The analyte value may be the flux of the analyte through the biological membrane or the concentration of the analyte in a body fluid of a subject. The medium may comprise a vinyl acetate based hydrogel, an agarose based hydrogel, or a polyethylene glycol diacrylate (PEG-DA) based hydrogel, for example. The surface region of the electrode may comprise pure platinum. The system may include an interference filter located between the biological membrane and the electrode assembly for reducing interference in the system. The system may comprise a processor programmed to implement an error correction method that corrects for sensor drift. (end of abstract)
Agent: Hunton & Williams LLP Intellectual Property Department - Washington, DC, US Inventors: Shikha P. Barman, Han Chuang USPTO Applicaton #: 20060094945 - Class: 600347000 (USPTO) Related Patent Categories: Surgery, Diagnostic Testing, Measuring Or Detecting Nonradioactive Constituent Of Body Liquid By Means Placed Against Or In Body Throughout Test, Electroanalysis, Blood Glucose The Patent Description & Claims data below is from USPTO Patent Application 20060094945. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] The present application is a divisional of U.S. application Ser. No. 11/201,334, filed Aug. 11, 2005, which is a continuation of U.S. application Ser. No. 10/974,963, filed Oct. 28, 2004, both of which are hereby incorporated by reference in their entireties. The present application is related to the following patent and applications, each of which is incorporated herein by reference it its entirety: U.S. application Ser. No. 09/979,096, filed Mar. 16, 2001; U.S. application Ser. No. 09/868,442, filed Dec. 17, 1999; U.S. Provisional Application No. 60/112,953, filed Dec. 18, 1998; U.S. Provisional Application No. 60/142,941, filed Jul. 12, 1999; U.S. Provisional Application No. 60/142,950, filed Jul. 12, 1999; U.S. Provisional Application No. 60/142,951, filed Jul. 12, 1999; U.S. Provisional Application No. 60/142,975, filed Jul. 12, 1999; U.S. Pat. No. 6,190,315; and U.S. Provisional Application No. 60/070,813, filed Jan. 8, 1998. BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to non-invasive sampling of body fluids, and, more particularly, to a system, method, and device for non-invasive body fluid sampling and analysis. [0004] 2. Description of the Related Art [0005] Diabetics frequently prick their fingers and forearms to obtain blood in order to monitor their blood glucose concentration. This practice of using blood to perform frequent monitoring can be painful and inconvenient. New, less painful methods of sampling body fluids have been contemplated and disclosed. For example, these painless methods include the use of tiny needles, [0006] the use of iontophoresis, and the use of ultrasound to sample body fluid, such as blood and interstitial fluid. [0007] It has been shown that the application of ultrasound can enhance skin permeability. Examples of such are disclosed in U.S. Pat. No. 4,767,402, U.S. Pat. No. 5,947,921, and U.S. Pat. No. 6,002,961, the disclosures of which are incorporated, by reference, in their entireties. Ultrasound may be applied to the stratum corneum via a coupling medium in order to disrupt the lipid bilayers through the action of cavitation and its bioacoustic effects. The disruption of stratum comeum, a barrier to transport, allows the enhanced diffusion of analyte, such as glucose or drugs, through, into, and out of the skin. [0008] Transport of analytes and body fluids can be enhanced further by the action of a motive force. These motive forces include, inter alia, sonophoretic, Iontophoretic, electromotive, pressure force, vacuum, electromagnetic motive, thermal force, magnetic force, chemomotive, capillary action, and osmotic. The use of active forces provide a means for obtaining fluid for subsequent analysis. [0009] The application of a motive force before, during, and after making the skin permeable has been disclosed in U.S. Pat. No. 5,279,543, U.S. Pat. No. 5,722,397, U.S. Pat. No. 5,947,921, U.S. Pat. No. 6,002,961, and U.S. Pat. No. 6,009,343, the disclosures of which are incorporated by reference in their entireties. The purpose of using a motive force is to actively extract body fluid and its content out of the skin for the purpose of analysis. As mentioned, active forces, such as vacuum, sonophoresis, and electrosmotic forces, can create convective flow through the stratum corneum. Although these forces can be used for extraction of body fluids, there are certain limitations that may apply when the forces are applied to human skin. For example, a major limitation is the flow and volume of body fluid that can be transported across the stratum comeum. In general, high-pressure force is necessary in order to transport fluid across an enhanced permeable area of stratum corneum. The application of vacuum on skin for an extended period may cause physical separation of the epidermis from the dermis, resulting in bruises and blisters. [0010] Another example of a limitation is the amount of energy that can be applied to the skin in order to create convective flow. Extraction of usable volume of body fluid has the potential to cause pain and skin damage with prolonged exposure to ultrasound. In a similar manner, electro-osmotic extraction of body fluid through stratum comeum has the potential to cause skin damage due the need to use high current density. It is evident that there are limitations to the use of the mentioned extraction methods when applied to human skin. SUMMARY OF THE INVENTION [0011] Therefore, a need has arisen for a system, method, and device for noninvasive body fluid sampling and analysis that overcomes these and other drawbacks of the related art. [0012] Therefore, a need has arisen for a method of enhancing the permeability of a biological membrane, such as skin, buccal, and nails, for an extended period of time, and a method for extracting body fluid to perform blood, interstitial fluid, lymph, or other body fluid analyte monitoring in a discrete or continuous manner that is noninvasive and practical. [0013] According to one embodiment, the invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane, wherein the medium comprises a hydrogel selected from the group consisting of vinyl acetate based hydrogels, agarose based hydrogels, polyethylene glycol diacrylate (PEG-DA) based hydrogels and mixtures thereof, and an electrode assembly, wherein the medium is adapted to react continuously with the analyte, and wherein an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. [0014] According to another embodiment, the invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane, and an electrode assembly comprising a plurality of electrodes, wherein a surface region of at least one of the electrode consists essentially of pure platinum, wherein the medium is adapted to react continuously with the analyte, and wherein an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. [0015] According to another embodiment, the invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane, an electrode assembly, and an interference filter located between the biological membrane and the electrode assembly for reducing interference from non-target biological moieties in the transdermal analyte monitoring system. [0016] According to another embodiment, the invention relates to a transdermal analyte monitoring system comprising a medium adapted to interface with a biological membrane and to receive an analyte from the biological membrane, a sensor comprising an electrode assembly, the electrode assembly comprising a plurality of electrodes, and a processor programmed to implement an error correction method that corrects for sensor drift, wherein the medium is adapted to react continuously with the analyte, and wherein an electrical signal is detected by the electrode assembly, and the electrical signal correlates to an analyte value. [0017] A method for non-invasive body fluid sampling and analysis is disclosed. 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. [0018] The area of biological membrane may be made permeable using ultrasound with controlled dosimetry. Extraction of body fluid may be performed on the area exposed to ultrasound using osmotic transport. The body fluid may be collected using a receiver. The receiver may be attached to the biological membrane in a form of a patch, a wearable reservoir, a membrane, an absorbent strip, a hydrogel, or an equivalent. The receiver may be analyzed for the presence of various analytes indicative of blood analytes. The analysis may comprise the use of electrochemical, biochemical, optical, fluorescence, absorbance, reflectance, Raman, magnetic, mass spectrometry, infra-red (IR) spectroscopy measurement methods and combinations thereof. The receiver may also be attached to a secondary receiver where the concentration of analyte in the secondary receiver is continuously maintained substantially lower than that in the body fluid so the chemical concentration driving force between body fluid and secondary receiver is maximized. This may be achieved by chemical reaction or volume for dilution or similar means. In one embodiment, the receiver and the secondary receiver may operate on different principles (e.g., osmosis, dilution, etc.). In another embodiment, the receivers may operate on the same principle. [0019] A system for non-invasive body fluid sampling and analysis is disclosed. 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 within the membrane. [0020] A method for noninvasive body fluid sampling and analysis is disclosed. According to one embodiment of the present invention, the method includes the steps of (1) enhancing a permeability level of an area of biological membrane; (2) attaching a receiver to the area of biological membrane; (3) extracting an analyte through and out of the area of biological membrane; (4) collecting the body fluid in the receiver; and (5) determining a concentration of at least one analyte in the body fluid. [0021] A device for noninvasive body fluid sampling and analysis is disclosed. According to one embodiment of the present invention, the device includes a receiver that is attached to an area of biological membrane with an enhanced permeability and receives body fluid through and out of the area of biological membrane, and a wearable meter that detects the presence of at least one analyte in the received body fluid and indicates a concentration of that analyte. The receiver may include a membrane and a medium, such as a hydrogel, a fluid, or a liquid, that is contained in the membrane. The meter may include a processor and a device that detects the presence of the analyte. The detecting device may include an electrochemical detector; a biochemical detector; a fluorescence detector; an absorbance detector; a reflectance detector; a Raman detector; a magnetic detector; a mass spectrometry detector; an IR spectroscopy detector; and combinations thereof. [0022] According to one embodiment of the present invention, osmotic forces may be used to sample body fluid from and through a biological membrane in an on-demand manner. The osmotic agent in solution, gel, hydrogel, or other form may be applied to the ultrasound-treated biological membrane using a receiver, such as a thin liquid reservoir, whenever the concentration of an analyte needs to be determined for diagnosis and monitoring. The receiver may be attached to the biological membrane using an adhesive. The receiver may be attached to the biological membrane for a brief duration. The solution in the receiver may be subsequently removed and analyzed for the presence of analytes. In one embodiment, the receiver may be constructed in the form of a patch. The receiver may contain a hydrogel and osmotic agent. The receiver may combine the osmotic agent and the chemical reagents to detect the presence of the analyte. The reagents may allow the use of electrochemical, biochemical, optical, fluorescence, absorbance, reflectance, Raman, magnetic, mass spectrometry, infrared (IR) spectroscopy measurement methods and combinations thereof to be performed on the receiver. Continue reading... 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