CA2598346A1 - Dynamic integrated lancing test strip with sterility cover - Google Patents

Dynamic integrated lancing test strip with sterility cover Download PDF

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Publication number
CA2598346A1
CA2598346A1 CA002598346A CA2598346A CA2598346A1 CA 2598346 A1 CA2598346 A1 CA 2598346A1 CA 002598346 A CA002598346 A CA 002598346A CA 2598346 A CA2598346 A CA 2598346A CA 2598346 A1 CA2598346 A1 CA 2598346A1
Authority
CA
Canada
Prior art keywords
test strip
lancet
incision
forming member
sterility
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
CA002598346A
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French (fr)
Other versions
CA2598346C (en
Inventor
Steven N. Roe
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.)
F Hoffmann La Roche AG
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Individual
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Filing date
Publication date
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Publication of CA2598346A1 publication Critical patent/CA2598346A1/en
Application granted granted Critical
Publication of CA2598346C publication Critical patent/CA2598346C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61B5/14532—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
    • 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
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling 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
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150282—Manufacture or production processes or steps for blood sampling devices for piercing elements, e.g. blade, lancet, canula, needle
    • 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
    • A61B5/150274—Manufacture or production processes or steps for blood sampling devices
    • A61B5/150297—Manufacture or production processes or steps for blood sampling devices for piercing devices, i.e. devices ready to be used for lancing or piercing
    • 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
    • A61B5/150389—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
    • A61B5/150503—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
    • A61B5/15107—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
    • A61B5/1513—Means for controlling the lancing movement, e.g. 2D- or 3D-shaped elements, tooth-shaped elements or sliding guides comprising linear sliding guides
    • 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
    • A61B5/15—Devices for taking samples of blood
    • A61B5/157—Devices characterised by integrated means for measuring characteristics of blood
    • 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
    • A61B5/150312—Sterilisation of piercing elements, piercing devices or sampling 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
    • A61B5/150007—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
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves

Abstract

An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Claims (24)

1. An apparatus, comprising:
a test strip adapted to analyze body fluid; and a packet coupled to the test strip, wherein the packet includes an incision forming member to form an incision in tissue, and a sterility sheet covering the packet to maintain sterility of the incision forming member and prevent cross-contamination between the test strip and the incision forming member, wherein the sterility sheet allows the incision forming member to be sterilized separately from the test strip.
2. The apparatus of claim 1, wherein the incision forming member defines an engagement opening for engaging the incision forming member during lancing.
3. The apparatus of claim 2, further comprising:
a meter including a cam arm with a blade that pierces the sterility sheet to engage the engagement opening of the lancet, and a firing mechanism coupled to the cam arm for firing the incision forming member.
4. The apparatus of claim 3, wherein the meter includes an adjustment mechanism to adjust position of the test strip relative to the tissue during sampling for minimizing flow constriction of the body fluid from the incision.
5. The apparatus of claim 3, wherein the test strip defines a relief opening that is aligned with the engagement opening for allowing the blade to extend completely through the engagement opening in the incision forming member.
6. The apparatus of claim 2, wherein the test strip defines a relief opening that is aligned with the engagement opening.
7. The apparatus of claim 1, further comprising:
a guide member with a guide slot in which the incision forming member is slidably disposed, wherein the guide slot defines a guide slot opening through which the incision forming member extends during lancing; and wherein the sterility sheet is folded to form two flaps with a crease in between that encloses the guide slot opening and the guide member is sandwiched between the flaps to enclose the guide slot.
8. The apparatus of claim 1, wherein the test strip defines a capillary opening in which the body fluid is drawn and a notch positioned proximal the packet to direct flow of the body fluid away from the incision forming member.
9. The apparatus of claim 1, wherein:
the incision forming member includes a lancet; and both the packet and test strip are generally flat to permit compact packaging.
10. The apparatus of claim 1, wherein the sterility sheet is hydrophobic for wiping the body fluid from the incision forming member during retraction.
11. The apparatus of claim 1, further comprising:
means for analyzing the body fluid, wherein the means for analyzing the body fluid includes the test strip;
means for forming the incision, wherein the means for forming the incision includes the incision forming member; and means for maintaining sterility of the incision forming member, wherein the means for maintaining sterility of the incision forming member includes the sterility sheet.
12. A method, comprising:
creating a lancet packet by enclosing a lancet in a sterility sheet to form a sterile enclosure;
sterilizing the lancet; and assembling an integrated lancing test strip by attaching the lancet packet to a test strip after said sterilizing the lancet.
13. The method of claim 12, wherein said sterilizing occurs after said creating the lancet packet.
14. The method of claim 12, wherein said sterilizing occurs before said creating the lancet packet.
15. The method of claim 12, wherein:
said creating the lancet packet includes providing a belt that includes a plurality of the lancets, and sandwiching the belt between the sterility sheet by the folding the sterility sheet around the belt.
16. The method of claim 15, further comprising cutting the integrated lancing test strip from the belt.
17. The method of claim 12, further comprising:

creating an engagement opening in the lancet;
creating a relief notch in the test strip; and wherein said assembling the integrated lancing test strip includes aligning the engagement opening of the lancet with the relief notch of the test strip.
18. A meter, comprising:
a holder configured to hold a test strip; and an adjustment mechanism cooperating with the holder to position the test strip relative to a tissue with an incision for reducing pressure applied against the tissue in order to minimize flow constriction of body fluid from the incision as the body fluid is collected with the test strip.
19. The meter of claim 18, further comprising:
the test strip;

a lancet coupled to the test strip to form an integrated lancing test strip;
a firing mechanism coupled to the holder for firing the lancet towards the tissue and for retracting the lancet from the incision.
20. The meter of claim 19, wherein the adjustment mechanism includes:
a connector coupled to one end of the test strip distal from the tissue, wherein the connector is slidably disposed relative to the holder; and a stop member that is moveable relative to the connector to adjust distance between the stop member and the connector, wherein the stop member is positioned to limit travel of the connector during retraction of the lancet.
21. The meter of claim 19, further comprising:
the integrated lancing test strip including a sterility sheet that encloses the lancet to maintain sterility of the lancet;
the lancet defining an engagement opening;
a connector coupled to one end of the test strip;
a cam arm pivotally coupled to the holder, wherein the cam arm includes a cam portion and a blade configured to pierce the sterility sheet;
and the connector being slidable relative to the holder to contact the cam portion and to rotate the pivot arm in order for the blade of the cam arm to pierce the sterility sheet and engage with the engagement opening in the lancet during loading of the integrated lancing test strip.
22. The meter of claim 18, further comprising a connector connecting the firing mechanism to the holder in a side-by-side orientation for compactly packaging the firing mechanism and the holder.
23. The meter of claim 18, further comprising:
a housing in which the holder is disposed;
a cap coupled to the housing; and a expression member threadedly coupled to the cap to allow the expression member to move relative to the cap in a telescoping manner, wherein the expression member defines a sample opening through which the test strip samples the body fluid.
24. The meter of claim 18, further comprising:
means for holding the test strip; and means for positioning the test strip relative to the tissue.
CA2598346A 2005-03-02 2006-03-01 Dynamic integrated lancing test strip with sterility cover Expired - Fee Related CA2598346C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/070,502 US7815579B2 (en) 2005-03-02 2005-03-02 Dynamic integrated lancing test strip with sterility cover
US11/070,502 2005-03-02
PCT/EP2006/001857 WO2006092281A2 (en) 2005-03-02 2006-03-01 Dynamic integrated lancing test strip with sterility cover

Publications (2)

Publication Number Publication Date
CA2598346A1 true CA2598346A1 (en) 2006-09-08
CA2598346C CA2598346C (en) 2012-05-15

Family

ID=36216280

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2598346A Expired - Fee Related CA2598346C (en) 2005-03-02 2006-03-01 Dynamic integrated lancing test strip with sterility cover

Country Status (10)

Country Link
US (3) US7815579B2 (en)
EP (1) EP1865844B1 (en)
JP (1) JP4712050B2 (en)
CN (1) CN101132732B (en)
AT (1) ATE546093T1 (en)
CA (1) CA2598346C (en)
ES (1) ES2380609T3 (en)
HK (1) HK1118002A1 (en)
PL (1) PL1865844T3 (en)
WO (1) WO2006092281A2 (en)

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