WO2003020134B1 - Wicking methods and structures for use in sampling bodily fluids - Google Patents

Wicking methods and structures for use in sampling bodily fluids

Info

Publication number
WO2003020134B1
WO2003020134B1 PCT/US2002/027465 US0227465W WO03020134B1 WO 2003020134 B1 WO2003020134 B1 WO 2003020134B1 US 0227465 W US0227465 W US 0227465W WO 03020134 B1 WO03020134 B1 WO 03020134B1
Authority
WO
WIPO (PCT)
Prior art keywords
sampling
inlet opening
incision
fluid
lancet
Prior art date
Application number
PCT/US2002/027465
Other languages
French (fr)
Other versions
WO2003020134A2 (en
WO2003020134A3 (en
Inventor
Edward P Perez
Original Assignee
Amira Medical
Edward P Perez
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Amira Medical, Edward P Perez filed Critical Amira Medical
Priority to EP02759486A priority Critical patent/EP1423049A2/en
Priority to JP2003524451A priority patent/JP2005501591A/en
Priority to CA002458208A priority patent/CA2458208A1/en
Priority to AU2002324818A priority patent/AU2002324818A1/en
Publication of WO2003020134A2 publication Critical patent/WO2003020134A2/en
Publication of WO2003020134A3 publication Critical patent/WO2003020134A3/en
Publication of WO2003020134B1 publication Critical patent/WO2003020134B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
    • A61B5/1451—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid
    • A61B5/14514—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood for interstitial fluid using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/150022—Source of blood for capillary blood or interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061—Means for enhancing collection
    • A61B5/150068—Means for enhancing collection by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150213—Venting means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150358—Strips for collecting blood, e.g. absorbent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150412—Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15105—Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15103—Piercing procedure
    • A61B5/15107—Piercing being assisted by a triggering mechanism
    • A61B5/15113—Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15115—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117—Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101—Details
    • A61B5/15126—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides
    • A61B5/15128—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/1519—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/151—Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186—Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188—Constructional features of reusable driving devices
    • A61B5/15192—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194—Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement

Abstract

A sampling member defines a passageway including an inlet opening for reception of a bodily fluid therein, and a wicking member having a first portion coupled with the sampling member adjacent to the inlet opening. The wicking member further includes a second portion displaced from the first portion for initially contacting the bodily fluid. In use the sampling member is placed adjacent to an incision site with the second portion of the wicking member positioned to have the bodily fluid first contact the wicking member and thereby draw the fluid from the incision site to the inlet opening. In related embodiments there is provided a sampling system and method which further includes a lancing device to create the incision and optionally expression members to urge the bodily fluid from the incision, preferably in an integrated unit.

Claims

AMENDED CLAIMS
[received by the International Bureau on 09 June 2003 (09.06.03); claims 1 and 2 amended, new claims 3-34 added (6 pages)]
L A sampling device for bodily fluids comprising: a sampling member defining a passageway including an inlet opening, the passageway configured for reception of the bodily fluid therein, said sampling member being positionable adjacent an incision site; and a wicking member having a first portion coupled with said sampling member at a location adjacent to the inlet opening, said wicking member further including a second portion displaced from the first portion, the second portion being closer to the incision site than the first portion when said sampling member is positioned adjacent to the incision site.
1. A method for collecting a bodily fluid from an incision site comprising: providing a sampling device including a sampling member defining a passageway including an inlet opening, the passageway configured for reception of the bodily fluid therein, the sampling device further including a wicking member having a first portion coupled with the sampling member at a location adjacent to the inlet opening, the wicking member further including a second portion displaced from the first portion; and positioning the sampling device adjacent to the incision site to have the second portion of the wicking member closer to the incision site than the first portion, whereby fluid at the incision site first contacts the wicking member and is thereby drawn from the incision site to the inlet opening of the sampling member.
3. The sampling device of claim 1, wherein: the sampling member has a top surface, a bottom surface and an aperture extending from the top surface to the bottom surface, the aperture being configured to surround the incision site; the inlet opening opens into the aperture; and the wicking member extends within the anerrnrfi
4. The sampling device of claim 3, further comprising a sealing member surrounding the aperture at the bottom surface of the sampling member to minimize fluid leakage.
5. The sampling device of claim 4, wherein the sealing member includes a hydrophobic surface to resist passage of the bodily fluid.
6. The sampling device of claim 4, further comprising a constricting system extending from the bottom surface to create a bulge of skin around the incision site.
7, The sampling device of claim 3, further comprising a constricting system provided around the aperture to create a bulge of skin around the incision site.
8. The sampling device of claim 7 , wherein the constricting system includes at least two deformable elements positioned on opposite sides of the aperture for engaging and constricting the skin.
9. The sampling device of claim 3, wherein the sampling member has a recessed surface between the inlet opening and the bottom surface to promote fluid flow into the inlet opening.
10. The sampling device of claim 1 , wherein the sampling member has a constricting system extending therefrom to create a bulge of skin around the incision site.
11. The sampling device of claim 1 , further comprising a test area in fluid communication with the passageway for testing the bodily fluid. 12, The sampling device of claim 11 , wherein the test area includes a test reagent covering absorbent material.
13. The sampling device of claim 1, wherein: the sampling member has a top surface, a bottom surface and an end edge; and the inlet opening communicates with the end edge at a location displaced from the bottom surface.
14. The sampling device of claim 13, wherein the sampling member has a recessed surface connecting between the inlet opening and the bottom surface.
15. The sampling device of claim 13, further comprising a sealing member located on the bottom surface to block passage of the bodily fluid.
16. The sampling device of claim 1 , further comprising: wherein the sampling member defines an aperture, the wicking member extending within the aperture; and a lancing device including a lancet for lancing skin, the lancing device defining a slot in which the sampling member is received, the aperture of the sampling member being positioned in alignment with the lancet in order for the lancet to lance the skin through the aperture,
17. The method of claim 2, further comprising lancing an incision into skin at the incision site with a lancet by extending the lancet through an aperture in the sampling member.
18, The method of claim 2, further comprising pressing a constricting system that extends from the sampling member to create a bulge of skin around the incision site.
1 . The method of claim 2, further comprising: drawing the fluid from the inlet opening, into the passageway and into a test area defined in the sampling member; and 5 testing the fluid in the test area.
20. A fluid sampling device, comprising: a test strip defining a passageway including an inlet opening, the test strip being positionable adjacent an incision, the passageway configured for reception of o bodily fluid from the incision; and means for wicking the fluid from the incision into the inlet opening positioned proximal the inlet opening.
21. The device of claim 20, wherein the means for wicking the fluid 5 includes a wicking member extending from the test strip adjacent the inlet opening.
22. The device of claim 20, wherein the means for wicking the fluid includes a lancet positioned adjacent the inlet opening and the incision, the lancet is provided with a hydrophilic outer surface to wick the fluid into the inlet opening. 0
23. A fluid sampling device, comprising: a sampling member defining a passageway including an inlet opening; a deformable expression member positioned proximal the inlet opening to form a bulge of skin upon pressing the expression member against the skin; and 5 a lancet configured to form an incision in the skin, the lancet extending proximal the inlet opening to draw fluid into the inlet opening.
24. The device of claim 23, wherein the lancet is slidably positioned inside the passageway. 0
25. The device of claim 24, wherein the sampling member includes a capillary tube.
26. The device of claim 24, further comprising a pressing member positioned inside the deformable expression member proximal the inlet opening to pull apart and maintain the incision open upon formation of the incision.
27. The device of claim 24, further comprising a test strip positioned within the passageway to test the fluid.
28. The device of claim 23, wherein the sampling member includes a capillary tube.
29. The device of claim 23, further comprising a pressing member positioned inside the deformable expression member proximal the inlet opening to pull apart and maintain the incision open upon formation of the incision.
30. The device of claim 23, further comprising a test strip positioned within the passageway to test the fluid.
31. The device of claim 23, wherein the expression member has a cylindrical shape.
32. A method of sampling bodily fluid from an incision, comprising: forming a bulge of skin by pressing a deformable expression member of a sampling device against the s in; lancing the bulge of the skin with a lancet of the sampling device to form the incision; and positioning the lancet proximal the incision to draw the fluid from the incision into an inlet opening of a passageway defined in a sampling member of the sampling device.
33. The method of claim 32, further comprising pressing a pressing member of the sampling device against the skin to spread apart the incision.
34. The method of claim 32, wherein: the sampling member includes a capillary tube; the lancet is longitudinally moveable inside the passageway in the capillary tube; and said lancing includes extending the lancet from the capillary tube.
PCT/US2002/027465 2001-08-29 2002-08-29 Wicking methods and structures for use in sampling bodily fluids WO2003020134A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
EP02759486A EP1423049A2 (en) 2001-08-29 2002-08-29 Wicking methods and structures for use in sampling bodily fluids
JP2003524451A JP2005501591A (en) 2001-08-29 2002-08-29 Exudation method and structure for use in sampling body fluid
CA002458208A CA2458208A1 (en) 2001-08-29 2002-08-29 Wicking methods and structures for use in sampling bodily fluids
AU2002324818A AU2002324818A1 (en) 2001-08-29 2002-08-29 Wicking methods and structures for use in sampling bodily fluids

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US31587301P 2001-08-29 2001-08-29
US60/315,873 2001-08-29

Publications (3)

Publication Number Publication Date
WO2003020134A2 WO2003020134A2 (en) 2003-03-13
WO2003020134A3 WO2003020134A3 (en) 2003-06-05
WO2003020134B1 true WO2003020134B1 (en) 2003-08-07

Family

ID=23226424

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/027465 WO2003020134A2 (en) 2001-08-29 2002-08-29 Wicking methods and structures for use in sampling bodily fluids

Country Status (6)

Country Link
US (1) US7264627B2 (en)
EP (1) EP1423049A2 (en)
JP (1) JP2005501591A (en)
AU (1) AU2002324818A1 (en)
CA (1) CA2458208A1 (en)
WO (1) WO2003020134A2 (en)

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