Method for Extracting Fluids from Tissue and Uses Thereof

• US 20170188913A1
• Filed: 12/30/2015
• Published: 07/06/2017
• Est. Priority Date: 12/30/2015
• Status: Active Application

• Current Assignee: Path Scientific, LLC
• Original Assignee: Path Scientific, LLC
• Inventors: Herndon, Terry O., Gowrishankar, Thiruvallur R.
• Application Number:
  US14/983,759
• Publication Number:
  US 20170188913A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The present invention relates to methods and devices for extraction of bodily fluids from tissue by creating microscopic openings in the outermost layers of the skin and drawing out the fluid. One embodiment of the invention is a cylindrical hollow member, made of electrically conducting material, with sharpened edges.

Claims

1. A device for extraction of bodily fluids from tissue comprising a drilling device with a dithering cutter, wherein the cutter is an electrically conducting cutting element that breaches the stratum corneum and/or the epidermis of the skin, a drive assembly that moves the cutting element in a dithering manner, repeatedly into and away from the skin thereby forming a hole in the tissue, an analyte sensing element, and an electronic control module for controlling the skin cutting element and means for collection of the body fluids from the hole created in the tissue.

2. The device of claim 1, wherein the cutter rotates as it moves into and out of the tissue.

3. The device of claim 1, wherein the surface of the cutter is roughened to enhance the surface tension between the cutter and the body fluids, thereby improving the extraction of the bodily fluid from the tissue.

4. The device of claim 1, wherein the cutter comprises a hollow member that dithers in and out of the skin to create an opening and collect fluid in the bore of the cutter.

5. The device of claim 4, wherein the hollow cutter rotates as it moves into and out of the tissue.

6. The device of claim 1, wherein the cutter rotates prior to and during the process of creating a hole, but does not rotate subsequently.

7. The device of claim 1, wherein the cutter comprises a hollow cylindrical member into which the blood or interstitial fluid is drawn for subsequent analysis.

8. A method of extracting bodily fluids from tissue which comprises repeating the following steps using the device of claim 1:

moving the cutting element toward the skin in a dither mode wherein the cutter is moved in small steps toward and away from the skin with a small bias in movement toward the skin, monitoring an electrical impedance, and reversing the direction of movement when a preset level of decrease in the electrical impedance is detected;

the procedure is repeated until a predetermined quantity of bodily fluid is collected.

9. The method of claim 8, wherein as the cutter moves into the tissue, it encounters fluid;

as the cutter starts to retract, and move away from the skin, the cutter pulls the fluid up, thus enlarging the bolus of fluid at the surface of the hole.

10. The method of claim 9, wherein an analyte sensing element is positioned near the skin surface and proximate to the cutter, such that when the fluid is drawn out of the skin, it contacts the sensing element.

11. The method of claim 8, wherein the cutter rotates as it moves into and out of the skin.

12. The method of claim 11, wherein the rotating cutter creates an opening in the skin large enough to produce a drop of blood or interstitial fluid.

13. The method of claim 12, wherein the blood or interstitial fluid is drawn out of the hole by surface tension.

14. The method of claim 8, wherein a non-rotating cutter that dithers through the skin, creates an opening, subsequently draws blood or interstitial fluid out by surface tension.

15. The method of claim 8, wherein the surface of the cutter is roughened to enhance the surface tension between the cutter and the body fluids, thereby improving the extraction of the bodily fluid from the tissue.

16. The method of claim 8, wherein the cutter comprises a hollow member that dithers in and out of the skin to create an opening and collect fluid in the bore of the cutter.

17. The method of claim 16, wherein the hollow cutter rotates as it moves into and out of the tissue.

18. The method of claim 8, wherein the cutter moves in a dither manner until a sufficient amount of blood or interstitial fluid is collected for blood glucose measurement.