CA2598916A1 - Integrated lancing test strip with retractable lancet - Google Patents

Integrated lancing test strip with retractable lancet Download PDF

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Publication number
CA2598916A1
CA2598916A1 CA002598916A CA2598916A CA2598916A1 CA 2598916 A1 CA2598916 A1 CA 2598916A1 CA 002598916 A CA002598916 A CA 002598916A CA 2598916 A CA2598916 A CA 2598916A CA 2598916 A1 CA2598916 A1 CA 2598916A1
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CA
Canada
Prior art keywords
lancet
test strip
incision
body fluid
integrated lancing
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
CA002598916A
Other languages
French (fr)
Other versions
CA2598916C (en
Inventor
Daniel Wong
Frank Chan
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
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of CA2598916A1 publication Critical patent/CA2598916A1/en
Application granted granted Critical
Publication of CA2598916C publication Critical patent/CA2598916C/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
    • A61B5/15—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
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • 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
    • A61B5/150213—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
    • A61B5/150007—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
    • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549—Protectors removed by rotational movement, e.g. torsion or screwing
    • 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
    • A61B5/150541—Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150564—Protectors removed by pulling or pushing
    • 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
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150618—Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • 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
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150702—Procedure for removing protection means at the time of piercing fully automatically removed, i.e. the removing does not require any action by the user
    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/32093—Incision instruments for skin incisions
    • 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
    • A61B2010/0003—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 including means for analysis by an unskilled person
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0295—Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
    • 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
    • A61B5/15115—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
    • A61B5/15123—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 magnets or solenoids
    • 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
    • A61B5/15125—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 a vacuum or compressed fluids

Abstract

An integrated lancing test strip device includes a lancet configured to form an incision in tissue and a test strip coupled to the lancet for analyzing body fluid. A retention mechanism acts as a detent to hold the lancet in a static position relative to the test strip before forming the incision. The retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip to reduce smearing of body fluid by the lancet during collection of the fluid with the test strip. In one form, the retention mechanism includes breakable tabs that are broken to release the lancet, and the lancet is retracted via translational movement. The retention mechanism in another form includes one or more dimples that release the lancet when the lancet is retracted via rotational motion. In a further form, the entire integrated device is rotated to collect fluid.

Claims (22)

1. An apparatus, comprising:
an integrated lancing test strip device including a lancet configured to form an incision in tissue, a test strip coupled to the lancet for analyzing body fluid from the incision, and a retention mechanism that holds the lancet in a static position relative to the test strip before formation of the incision, wherein the retention mechanism is configured to release the lancet for retracting the lancet relative to the test strip in order to reduce interference by the lancet during collection of the body fluid with the test strip.
2. The apparatus of claim 1, further comprising a protective cover covering at least a portion of the lancet, wherein the retention mechanism holds the lancet during removal of the protective cover.
3. The apparatus of claim 1, wherein the retention mechanism includes one or more breakable tabs coupled between the lancet and the test strip, wherein the breakable tabs are configured to break when a predefined force is applied to permit retraction of the lancet.
4. The apparatus of claim 1, wherein the retention mechanism includes one or more retention dimples that engage the lancet, wherein the dimples are configured to release the lancet when a predefined force is applied to permit retraction of the lancet.
5. The apparatus of claim 1, wherein the lancet is configured to retract in a translational fashion relative to the test strip.
6. The apparatus of claim 1, wherein the lancet is rotatably coupled to the test strip for retracting in a rotational fashion relative to the test strip.
7. The apparatus of claim 1, wherein the lancet defines one or more engagement openings for transmitting force during retraction.
8. The apparatus of claim 1, wherein when in the fixed position at least a portion of the lancet extends from the test strip.
9. The apparatus of claim 1, wherein:
when in the fixed position the lancet is positioned in a retracted position inside the integrated lancing test strip to reduce risk of injury; and the retention mechanism releases the lancet to allow at least a portion of the lancet to extend from the test strip during formation of the incision.
10. The apparatus of claim 1, wherein the retention mechanism is configured to hold the lancet in a retracted position after formation of the incision to reduce risk of injury during disposal of the integrated lancing test strip device.
11. The apparatus of claim 1, further comprising:
an actuation mechanism coupled to the integrated lancing test strip, wherein the actuation mechanism includes a deflection mechanism configured to swipe the test strip over the body fluid from the incision.
12. The apparatus of claim 11, wherein the actuation mechanism includes a retraction mechanism configured to apply force to release the lancet from the retention mechanism and retract the lancet.
13. A method, comprising:
holding a lancet in a fixed position relative to a test strip of an integrated lancing test strip device;

forming an incision in tissue with at least a portion of the lancet extending from the test strip;
releasing the lancet from the fixed position;
retracting the lancet after said forming the incision; and collecting body fluid from the incision with the test strip after said retracting the lancet.
14. The method of claim 13, wherein said releasing the lancet occurs after said forming the incision.
15. The method of claim 13, wherein:
said holding the lancet in the fixed position includes having the lancet in a retracted position;
said releasing the lancet occurs before said forming the incision; and said forming the incision includes extending at least a portion of the lancet from the test strip.
16. The method of claim 13, wherein said retracting includes rotating the lancet relative to the test strip.
17. The method of claim 13, wherein said retractring includes translational moving of the lancet relative to the test strip.
18. An integrated lancing test strip device, comprising:
means for creating an incision in tissue;
means for analyzing body fluid from the incision; and means for holding said means for creating the incision in relation to said means for analyzing the body fluid and for releasing said means for creating the incision upon application of force.
19. The device of claim 18, wherein:

said means for creating the incision includes a lancet;
said means for analyzing the body fluid includes a test strip; and said means for holding includes a detent mechanism.
20. An apparatus, comprising:
an integrated lancing test strip device including a test strip for analyzing body fluid, the test strip having a capillary channel with an opening for drawing the body fluid via capillary action, wherein the test strip is flat, and a lancet directly coupled to the test strip for forming an incision in tissue; and an actuation device coupled to the integrated lancing test strip device, the actuation device being configured to fire the lancet into the tissue, wherein the actuation device is configured to rotate the lancet away from the incision in order to minimize interference by the lancet as the body fluid from the incision is drawn into the capillary channel of the test strip.
21. The apparatus of claim 20, wherein:

the lancet is pivotally coupled to the test strip; and the actuation device is configured to rotate the lancet relative to the test strip.
22. The apparatus of claim 20, wherein:
the lancet is fixed to the test strip;
the capillary channel is angled in a nonparallel manner relative to the lancet;
the actuation device is configured to rotate the lancet away from the incision by rotating the entire integrated lancing test strip device; and the test strip has a truncated corner at the opening of the capillary channel to reduce smearing of the body fluid as the integrated lancing test strip device is rotated.
CA2598916A 2005-04-12 2006-04-10 Integrated lancing test strip with retractable lancet Expired - Fee Related CA2598916C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US11/103,871 2005-04-12
US11/103,871 US7695442B2 (en) 2005-04-12 2005-04-12 Integrated lancing test strip with retractable lancet
PCT/EP2006/003272 WO2006108597A2 (en) 2005-04-12 2006-04-10 Integrated lancing test strip with retractable lancet

Publications (2)

Publication Number Publication Date
CA2598916A1 true CA2598916A1 (en) 2006-10-19
CA2598916C CA2598916C (en) 2012-07-24

Family

ID=36572407

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2598916A Expired - Fee Related CA2598916C (en) 2005-04-12 2006-04-10 Integrated lancing test strip with retractable lancet

Country Status (11)

Country Link
US (3) US7695442B2 (en)
EP (1) EP1871220B1 (en)
JP (1) JP4726948B2 (en)
CN (1) CN101155547B (en)
AT (1) ATE446046T1 (en)
CA (1) CA2598916C (en)
DE (1) DE602006009912D1 (en)
ES (1) ES2334703T3 (en)
HK (1) HK1121660A1 (en)
PL (1) PL1871220T3 (en)
WO (1) WO2006108597A2 (en)

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