Non-or minimally invasive monitoring methods

a monitoring method and non-invasive technology, applied in the field of non-invasive monitoring methods, can solve the problems of poor patient compliance, hypoglycemia, coma and death, etc., and achieve the effect of accurate results

Inactive Publication Date: 2005-03-24
KWON SUNG YUN +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides an apparatus and method for continuous or rapid intermittent monitoring of the concentration of a target analyte in a body fluid essentially without net mass fluid transport. This is achieved by diffusion of the target analyte between the body fluid and an interface contact element. The body fluid is exposed via micro-pathways that allow the body fluid to interface with the interface contact element. A portal generator, such as a particle injection device, is used to create such micro-pathways. A sensor (e.g., a hydrogel), comprising the interface contact element and a sensing material, can be incorporated into a patch that

Problems solved by technology

On the other hand, improper administration of insulin therapy can result in hypoglycemic episodes, which can result in coma and death.
However, the pain and inconvenience associated with this blood sampling, has lead to poor patient compliance, despite strong evidence that precise-maintained control dramatically reduces long-term diabetic complications.
In fact, these considerations can often lead to an abatement of the monitoring process by the diabetic.
Due to the low

Method used

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Examples

Experimental program
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Effect test

example 1

This example shows the relationship between analyte concentration within an experimental system and the signal obtained from analyte measurement using an interface contact element that is in contact with the external surface of that system. A modified Franz cell testing apparatus was used to model skin tissue containing glucose analyte in interstitial fluid. The donor part of the bottom of the Franz cell was filled with a liquid that approximated interstitial fluid, and various amounts of glucose were added to the liquid. Human cadaver skin was placed over the top of the Franz cell to provide the external monitoring surface.

More particularly, interstitial fluid is the clear body fluid found between cells in the top surface layers of skin, i.e., the dermis and epidermis. Dermal interstitial fluid glucose concentrations have been shown to be directly proportional to blood glucose concentrations (J Lab Clin Med. 1997; 130:436-441) thus measurement of the glucose level in this fluid ...

example 2

The purpose of the following example was to demonstrate the ability of a sensor constructed according to the present invention to track analyte concentration within a dynamic test system. The sensor was also assessed for its ability to detect and provide analyte concentration measurements from a changing system.

The materials and methods used in Example 1 above were employed in this Example 2; however, the concentration of the glucose analyte within the modified Franz cell (within the donor chamber) was changed over approximately ten minute intervals from 0 mg / dl to approximately 400 mg / dl and then to 0 mg / dl. The cycle was repeated once the experimental value reached the actual concentration. An electrochemical sensor / detector was used to generate an output signal in nanoamperes detected by continuous contact with a custom fabricated signal reading device. The response of the sensor to the change in glucose concentration was monitored over time and translated into glucose concent...

example 3

The following study is carried out to assess continuous monitoring of analyte concentration using the methods and apparatus of the present invention. More particularly, in vivo tests are performed on diabetic patients or healthy volunteers using intravenous lines with pumps to deliver insulin and glucose, and an indwelling sensor catheter (Biostator, Life Science Instruments, Elkhart, Ind.) to measure real-time glucose concentration in the blood. In the healthy volunteers, a low dose intravenous infusion of somatostatin is used to suppress the body's natural insulin release in response to glucose administration (Diabetes Tech. &Ther., 2000; 2:211-220). The interface contact element and sensor are applied to an abdominal site (or other suitable target surface) that is pretreated to create micro-pathways (e.g., by particle injection). The subjects do not have a history of skin problems (i.e., dermatitis, eczema, psoriasis, or keloid formation). The subjects are subjected to several p...

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PUM

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Abstract

An apparatus for sensing an analyte is described, wherein the apparatus includes an interface contact element that is used to establish an interface with a quantity of body fluid. The interface contact element is adapted to facilitate diffusion of a target analyte across the interface essentially free of net mass fluid transport. The quantity of body fluid is exposed to the interface contact element through micro-pathways. The apparatus can also include a sensing material adapted to sense the target analyte with at least one analytical method. Methods for using the apparatus in a non- or minimally invasive monitoring technique are also described. FIG. (1) illustrates a non-limiting embodiment of the apparatus used to test the principles of the invention.

Description

FIELD OF THE INVENTION The present invention relates to methods of continuous or rapid intermittent monitoring of body fluid for the presence and / or concentration of target analytes. More particularly, the invention relates to using diffusion of a target analyte from a body fluid such as interstitial fluid via a micro-pathway, and an interface contact element that is used to establish an equilibrium of analyte concentration between the body fluid and the interface contact element. The concentration of the target analyte can then be measured using a sensing material, thereby providing for continuous analyte monitoring such as continuous glucose monitoring by diabetic or hypoglycemic subjects. BACKGROUND OF THE INVENTION A number of tests are routinely performed on humans to evaluate the amount or existence of substances present in blood or other body fluids. These tests typically rely on physiological fluid samples removed from a subject, either using a syringe or by pricking the s...

Claims

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Application Information

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IPC IPC(8): A61B5/00A61B10/00A61B17/00A61B17/54C12M1/34C12Q1/54G01N33/66
CPCA61B5/14514A61B5/14532A61B5/1486G01N33/66A61B2010/008A61B2017/00747A61B2017/00765A61B17/545
Inventor KWON, SUNG-YUNBURKOTH, TERRY L.
Owner KWON SUNG YUN
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