CA2424288A1 - Device and method for obtaining interstitial fluid from a patient for diagnostic tests - Google Patents

Device and method for obtaining interstitial fluid from a patient for diagnostic tests Download PDF

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Publication number
CA2424288A1
CA2424288A1 CA002424288A CA2424288A CA2424288A1 CA 2424288 A1 CA2424288 A1 CA 2424288A1 CA 002424288 A CA002424288 A CA 002424288A CA 2424288 A CA2424288 A CA 2424288A CA 2424288 A1 CA2424288 A1 CA 2424288A1
Authority
CA
Canada
Prior art keywords
tube
patient
interstitial fluid
assembly
wall
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
CA002424288A
Other languages
French (fr)
Other versions
CA2424288C (en
Inventor
Timothy P. Henning
Michael G. Lowery
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
Timothy P. Henning
Michael G. Lowery
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 Abbott Laboratories, Timothy P. Henning, Michael G. Lowery filed Critical Abbott Laboratories
Publication of CA2424288A1 publication Critical patent/CA2424288A1/en
Application granted granted Critical
Publication of CA2424288C publication Critical patent/CA2424288C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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
    • 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
    • A61B5/150099—Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • 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
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, 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
    • A61B5/150442—Blade-like piercing elements, e.g. blades, cutters, knives, for cutting 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
    • A61B5/150007—Details
    • A61B5/150946—Means for varying, regulating, indicating or limiting the speed or time of blood collection
    • 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
    • A61B5/150969—Low-profile devices which resemble patches or plasters, e.g. also allowing collection of blood samples for testing
    • 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
    • A61B5/15142—Devices intended for single use, i.e. disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/008—Interstitial fluid

Abstract

A device for obtaining a sample of interstitial fluid from a patient for use in monitoring the level of blood glucose in the patient. The device comprise s a hollow tube having a wall surrounding a cavity, wherein the wall of the tu be contains a multiplicity of pores. The hollow tube is inserted into the tissu es through the skin with the help of anintroduction needle. No external suction is applied.

Claims (18)

1. A device suitable for use in withdrawing fluid from an opening formed in the skin of a patient, said device comprising a hollow tube comprising a wall surrounding a cavity, said hollow tube having a first end and a second end, said wall running from said first end to said second end, said wall having a multiplicity of pores formed therein.
2. The device of claim 1, wherein said wall of said tube comprises a polymeric material.
3. The device of claim 1, wherein said tube has a length ranging from about 2 mm to about 10 mm.
4. The device of claim 1, wherein said tube has a length ranging from about 5 mm to about 10 mm.
5. The device of claim 1, wherein said tube has an inside diameter ranging from about 0.25 mm to about 1.25 mm.
6. The device of claim 1, wherein said tube has an outside diameter ranging from about 0.45 mm to about 2.25 mm.
7. The device of claim 1, wherein said tube is cylindrical in shape.
8. The device of claim 1, wherein said tube is in the shape of a parallelepiped.
9. The device of claim 1, wherein said wall of said tube has a porosity of from about 1% to about 10%.
10. The device of claim 1, wherein the number of pores per mm of tube length ranges from about 10 to about 10,000.
11. The device of claim 1, wherein said pores have a diameter ranging from about 0.005 mm to about 1 mm.
12. The device of claim 1, wherein the ratio of the diameter of said pores to the inside diameter of said tube does not exceed 1.
13. An assembly for obtaining fluid from an opening formed in the skin of a patient comprising:
(a) the device of claim 1;
(b) an elongated element capable of forming said opening in said skin;
said elongated element capable of being inserted in said first end of said hollow tube and projecting beyond said second end of said tube.
14. The assembly of claim 13, further including a patch bearing a layer of adhesive on one major surface thereof for adhering said assembly to said skin.
15. The assembly of claim 13, further including a holder for said elongated element.
16. The assembly of claim 13, further including guides for aligning a detector holder.
17. A method for obtaining interstitial fluid from the body of a patient, said method comprising the steps of:
(a) inserting the device of claim 1 into said body of said patient; and (b) collecting interstitial fluid from said body of said patient, said interstitial fluid exiting from said first end of said tube.
18. The method of claim 17, further including the step of determining the blood glucose level from said collected interstitial fluid.
CA2424288A 2000-10-12 2001-10-11 Device and method for obtaining interstitial fluid from a patient for diagnostic tests Expired - Fee Related CA2424288C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/689,527 US6537243B1 (en) 2000-10-12 2000-10-12 Device and method for obtaining interstitial fluid from a patient for diagnostic tests
US09/689,527 2000-10-12
PCT/US2001/032006 WO2002030488A2 (en) 2000-10-12 2001-10-11 Device and method for obtaining interstitial fluid from a patient for diagnostic tests

Publications (2)

Publication Number Publication Date
CA2424288A1 true CA2424288A1 (en) 2002-04-18
CA2424288C CA2424288C (en) 2011-04-26

Family

ID=24768845

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2424288A Expired - Fee Related CA2424288C (en) 2000-10-12 2001-10-11 Device and method for obtaining interstitial fluid from a patient for diagnostic tests

Country Status (8)

Country Link
US (1) US6537243B1 (en)
EP (1) EP1326533B1 (en)
JP (1) JP4198986B2 (en)
AT (1) ATE314007T1 (en)
CA (1) CA2424288C (en)
DE (1) DE60116351T2 (en)
ES (1) ES2256308T3 (en)
WO (1) WO2002030488A2 (en)

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Also Published As

Publication number Publication date
EP1326533B1 (en) 2005-12-28
WO2002030488A3 (en) 2002-08-29
JP4198986B2 (en) 2008-12-17
CA2424288C (en) 2011-04-26
JP2004531281A (en) 2004-10-14
DE60116351D1 (en) 2006-02-02
DE60116351T2 (en) 2006-09-14
US6537243B1 (en) 2003-03-25
EP1326533A2 (en) 2003-07-16
WO2002030488A2 (en) 2002-04-18
ATE314007T1 (en) 2006-01-15
ES2256308T3 (en) 2006-07-16

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