WO2006082106B1 - Lancet protective cap - Google Patents

Lancet protective cap

Info

Publication number
WO2006082106B1
WO2006082106B1 PCT/EP2006/001036 EP2006001036W WO2006082106B1 WO 2006082106 B1 WO2006082106 B1 WO 2006082106B1 EP 2006001036 W EP2006001036 W EP 2006001036W WO 2006082106 B1 WO2006082106 B1 WO 2006082106B1
Authority
WO
WIPO (PCT)
Prior art keywords
web
lancing
tip
lancet
layer
Prior art date
Application number
PCT/EP2006/001036
Other languages
French (fr)
Other versions
WO2006082106A1 (en
Inventor
Frank A Chan
Original Assignee
Roche Diagnostics Gmbh
Hoffmann La Roche
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 Roche Diagnostics Gmbh, Hoffmann La Roche filed Critical Roche Diagnostics Gmbh
Priority to EP06723003A priority Critical patent/EP1848339B1/en
Priority to JP2007553561A priority patent/JP4861337B2/en
Priority to CN2006800042347A priority patent/CN101115441B/en
Priority to CA2596652A priority patent/CA2596652C/en
Publication of WO2006082106A1 publication Critical patent/WO2006082106A1/en
Publication of WO2006082106B1 publication Critical patent/WO2006082106B1/en
Priority to HK08107792.7A priority patent/HK1117016A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/15061Joining techniques used for protective means by material engagement, e.g. welding, bonding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150274Manufacture or production processes or steps for blood sampling devices
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150564Protectors removed by pulling or pushing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150801Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150358Strips for collecting blood, e.g. absorbent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles

Abstract

A unique technique for maintaining the sterility and integrity of a lancet tip. One or more lancet tips (34) are sandwiched between a first web (22) and a second web (24) of material to protect the sterility of the lancet tips. The first and second webs are heat fused together to form a structure that covers and encapsulates the lancet tips to protect the integrity of the lancet tips. The structure is cut to form individual protective caps to detachably cover each of the lancet tips.

Claims

received by the International Bureau on 10 August 2006 (10.08.2006)23034 WOWhat is claimed is:
1. A method for covering a lancing tip, comprising: sandwiching at least a lancing tip between a first web of material resistant to melting at a specific temperature and a second web of material meltable at the specific temperature; and melting the second web by heating both the first web and the second web to at least the specific temperature in order to encapsulate at least the lancing tip in a sterile enclosure; wherein during the melting the first web remains in an unmelted state to form a ribbon to protect integrity of at least the lancing tip.
2. The method of claim 1, further comprising: cooling the second web to form a removable cap covering at least the lancing tip.
3. The method of claim 1 , further comprising: cutting the first web and the second web to a desired shape to form a pull-off tab.
4. The method of claim 1 , wherein: the first web includes a multi-layered material having a first material resistant to melting at the specific temperature and a second material meltable at the specific temperature; and said melting the second web includes melting the second material of the first web while the first material remains in an unmelted state.
5. The method of claim 1 , wherein: the second web includes a multi-layered material having a first material resistant to melting at the specific temperature and a second material meltable at the specific temperature; and said melting the second web includes melting the second material of the second web while the first material remains in an unmelted state.
6. The method of claim 1 , wherein said sandwiching at least the lancing tip includes sandwiching a plurality of the lancing tips between the first web and the second web.
7. The method of claim 1, further comprising: wherein said sandwiching at least the lancing tip includes sandwiching a plurality of the lancing tips between the first web and the second web; wherein the ribbon protects the integrity of at least the plurality of lancing tips; and storing the plurality of lancing tips and the ribbon in a cartridge.
8. The method of claim 1 , further comprising: attaching the lancing tip to a test strip configured to analyze body fluid to form an integrated lancing test strip.
9. The method of claim 8, further comprising: sterilizing the lancing tip before attaching the lancing tip to the test strip to form the integrated lancing test strip.
10. The method of claim 8, further comprising: sterilizing the lancing tip after attaching the lancing tip to the test strip to form the integrated lancing test strip; and calibrating the integrated lancing test strip wherein the test strip is configured to analyze a bodily fluid sample.
11. The method of claim 1 , further comprising: providing an indicator on the ribbon to show a direction for removing the ribbon to expose the lancing tip.
12. A device, comprising: a lancet having a lancet tip configured to form an incision in skin; a first web of a multi-layered material, wherein the multi-layered material has a heat-resistant first layer and a heat-sensitive second layer; and a second web of the multi-layered material, the second layer of the second web contacting the second layer of the first web and sandwiching the lancet tip between the first web and the second web to protect sterility of the lancet tip; wherein the second layer of the first web and the second layer of the second web are melted together to form a structure to encapsulate the lancet tip.
13. The device of claim 12, wherein: the first layer includes polystyrene; and the second layer includes polyethylene.
14. The device of claim 12, further comprising: a plurality of the lancet tips sandwiched between the first web and the second web.
15. The device of claim 12, further comprising: a plurality of the lancet tips sandwiched between the first web and the second web; a plurality of the structures configured to encapsulate said plurality of the lancet tips; and a cartridge for storing the plurality of the structures and the plurality of the lancet tips.
16. The device of claim 12, wherein the structure is severable to form a protective cap to cover the lancet tip .
17. The device of claim 12, wherein the first layer is rigid to form a protective outer surface of the structure.
18. The device of claim 12, further comprising: a test strip attached to the lancet and adapted to analyze bodily fluid from the incision.
19. An apparatus, comprising : means for forming an incision; means for encapsulating said means for forming an incision in a sterile environment comprising a first web including at least a single layer whereas a portion of the first web is meltable at a temperature; and means for strengthening said means for encapsulating comprising a second web including at least a single layer whereas a portion of the second web is resistant to melting at the temperature, wherein said means for strengthening protects integrity of said means for forming an incision, and the means for forming an incision is sandwiched between the first and the second web.
20. The apparatus of claim 19, further comprising: means for analyzing a body fluid from the incision.
21. The apparatus of claim 19, wherein: said means for forming the incision includes a lancet; said means for encapsulating includes a first web of a multi-layered material and a second web of the multi-layered material, wherein the multi-layered material has a heat-resistant first layer and a heat-sensitive second layer; and said means for strengthening includes the first layer that is rigid.
PCT/EP2006/001036 2005-02-07 2006-02-07 Lancet protective cap WO2006082106A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
EP06723003A EP1848339B1 (en) 2005-02-07 2006-02-07 Lancet protective cap
JP2007553561A JP4861337B2 (en) 2005-02-07 2006-02-07 Lancet protection cap
CN2006800042347A CN101115441B (en) 2005-02-07 2006-02-07 Lancet protective cap
CA2596652A CA2596652C (en) 2005-02-07 2006-02-07 Lancet protective cap
HK08107792.7A HK1117016A1 (en) 2005-02-07 2008-07-15 Lancet protective cap

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US11/052,610 US7479118B2 (en) 2005-02-07 2005-02-07 Lancet protective cap
US11/052,610 2005-02-07

Publications (2)

Publication Number Publication Date
WO2006082106A1 WO2006082106A1 (en) 2006-08-10
WO2006082106B1 true WO2006082106B1 (en) 2006-11-16

Family

ID=36498991

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2006/001036 WO2006082106A1 (en) 2005-02-07 2006-02-07 Lancet protective cap

Country Status (7)

Country Link
US (3) US7479118B2 (en)
EP (1) EP1848339B1 (en)
JP (1) JP4861337B2 (en)
CN (1) CN101115441B (en)
CA (1) CA2596652C (en)
HK (1) HK1117016A1 (en)
WO (1) WO2006082106A1 (en)

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Also Published As

Publication number Publication date
EP1848339A1 (en) 2007-10-31
JP2008529571A (en) 2008-08-07
CN101115441B (en) 2010-06-16
CN101115441A (en) 2008-01-30
US8062233B2 (en) 2011-11-22
US8608668B2 (en) 2013-12-17
EP1848339B1 (en) 2012-07-11
US20090124933A1 (en) 2009-05-14
US20110270130A1 (en) 2011-11-03
HK1117016A1 (en) 2009-01-09
WO2006082106A1 (en) 2006-08-10
JP4861337B2 (en) 2012-01-25
US20060174592A1 (en) 2006-08-10
CA2596652A1 (en) 2006-08-10
CA2596652C (en) 2012-05-22
US7479118B2 (en) 2009-01-20

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