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EP1032306A1 - Dispositif de prelevement par lancette appliquee par le patient lui-meme - Google Patents

Dispositif de prelevement par lancette appliquee par le patient lui-meme

Info

Publication number
EP1032306A1
EP1032306A1 EP98955265A EP98955265A EP1032306A1 EP 1032306 A1 EP1032306 A1 EP 1032306A1 EP 98955265 A EP98955265 A EP 98955265A EP 98955265 A EP98955265 A EP 98955265A EP 1032306 A1 EP1032306 A1 EP 1032306A1
Authority
EP
European Patent Office
Prior art keywords
lancet
base member
locating means
sleeve
arm
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.)
Ceased
Application number
EP98955265A
Other languages
German (de)
English (en)
Other versions
EP1032306A4 (fr
Inventor
Dale Robert Brakey
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.)
Medigate Manufacturing Pte Ltd
Original Assignee
Medigate Manufacturing Pte Ltd
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 Medigate Manufacturing Pte Ltd filed Critical Medigate Manufacturing Pte Ltd
Publication of EP1032306A1 publication Critical patent/EP1032306A1/fr
Publication of EP1032306A4 publication Critical patent/EP1032306A4/fr
Ceased legal-status Critical Current

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
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices 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
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/15192Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194Constructional 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
    • 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
    • A61B5/150259Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • 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
    • A61B5/150435Specific design of proximal end
    • 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
    • A61B5/150519Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • 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
    • A61B5/150549Protectors removed by rotational movement, e.g. torsion or screwing
    • 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
    • A61B5/150618Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • 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
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15113Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
    • 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
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving 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
    • A61B5/15117Driving 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

Definitions

  • This invention relates to a capillary blood sampling device.
  • Application No. 10101/95 is directed to a one-piece moulding of the delivery system including the needle requiring disposal of the total device after a single use which, to an extent, lessens the cost effectiveness of the device, although not its effectiveness in use.
  • the present invention also offers important benefits including, the bubble up effect which enables unadulterated sampling, a recoiling arm to control accuracy, depth of penetration and reliability of sampling, and a pressure release mechanism to minimise pain.
  • the present invention also features a sterile needle, controlled delivery of lancet, enhanced design of needle tip to minimise pain, administration with one hand and a reusable delivery system.
  • the present invention provides a blood sampling device comprising a lancet delivery system comprising of a base member, a resiliently mounted recoiling arm member angularly extending from and above one end of the base member and having apertured lancet locating means at the outer end of the arm member, an aperture in the base member in alignment with said apertured lancet locating means, a lancet located within a moulded plastics material casing and adapted to be inserted and lockable in said locating means in a manner allowing removal therefrom after use, a hinged sleeve member located in said base member aperture and extending with respect to the base member, a latch member secured between the base member and said sleeve and operable to engage under an abutment on the lancet locating means to hold the device in an operable setting and whereby pressure on the said hinged sleeve member hinges the latch member out of engagement with said abutment and allows rapid movement of said recoiling arm and its lancet downwards through said hinge
  • an end of the hinged sleeve member is counterbored to provide a tapered lead- in to the sleeve which can in use cause the skin of a fmger tip or other part of the body to bulge up within the sleeve so as to bring the skin into proximity to the sharp end of the lancet.
  • the internal diameter of the hinged sleeve is within the range of 0.35 to 0.70 cm and more preferably 0.50 to 0.60 cm.
  • the pointed end of the lancet is provided with a moulded removable cover which protects the user from accidental sticking during handling and maintains a piercing point in sterile condition, said removable cover being easily twisted off just before use.
  • the encased lancet is located in the lancet locating aperture through slots engageable by protrusions on the moulded encasement of the lancet which encasement is rotated out of engagement with the slots into a releasable locking position.
  • Figure 1 is a side elevation of a blood sampling device according to one form of the invention
  • Figure 2 is an end elevation taken in the direction of the arrow 2 of Figure 1;
  • Figure 3 is a plan view taken along the line 3-3 of Figure 1;
  • Figure 4 is a sectional view taken along the line 4-4 of Figure 3;
  • Figure 5 is a part-sectional view showing the lancet locked in position in its locating means.
  • Figure 6 is an elevational view partly in section of the device cocked and ready for use.
  • the capillary blood sampling device is generally designated 5 and is preferably formed of moulded plastics material with the delivery system 6 thereof formed as a separate moulding, normally by injection moulding, from the lancet holder 7, also an injection moulding.
  • the delivery system 6 includes a base member 8 which is provided with serrations 9 acting as means to assist gripping of the system.
  • a recoiling arm member 10 is resiliency mounted at one end of base member 8 and extends over and above the base member 8 at an angle thereto, preferably 25° - 30°.
  • a sleeve member 12 Towards the end of base member 8 remote from the mounting of arm member 10 there is formed an aperture 11 in which is hingedly located a sleeve member 12 and wherein the hinge consists of an integrally moulded flexible lower part 13 of an upstanding latch member 14.
  • the sleeve member 12 preferably protrudes below the underside of the base member 8 to allow engagement therewith under pressure by a fmger or some other part of the body from which a sample is to be taken.
  • an apertured cylindrical part 15 adapted to releasably locate a lancet holder 7 in a locked condition.
  • the cylindrical part 15 is provided internally with vertically extending slots 16 engageable by diametrically extending protrusions 17 on the lancet holder 7 whereby on full insertion of the holder 7 into cylindrical part 15 and through the end thereof, the holder 7 may be rotated when the protrusions 17 can just clear the cylindrical part 15 and engage under a non-slotted part of cylindrical part 15 under a frictional pressure grip.
  • the lower part 18 of lancet holder 8 covering the sharp point 19 of the lancet 23 is joined to the lancet holder 7 by a weakened part 20 whereby on twisting lower part 18 to break away said lower part 18, the end sharp point 19 is exposed ready for use as shown in Figure 6.
  • the lower end 21 of cylindrical part 15 is provided on its outer surface with an abutment 22 engageable by the upper end of latch member 15 with arm member 10 lifted to a spring loaded position as shown in Figure 6.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Dermatology (AREA)
  • Manufacturing & Machinery (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif permettant de prélever du sang (5). Ce dispositif comprend un système de mise en place d'une lancette se composant d'un élément de base (8), d'un bras (10) à rappel, monté de manière élastique, et s'étendant de manière angulaire, à partir et au-dessus d'une extrémité de l'élément de base (8) et comportant un moyen à ouverture (15) assurant le positionnement de la lancette, au niveau de l'extrémité extérieure du bras (10). Une ouverture ménagée dans l'élément de base (8) est alignée sur le moyen de positionnement de la lancette (15). Une lancette (23) placée dans un support de plastique moulé (7) est adaptée pour être insérée et verrouillée dans le moyen de positionnement (15) d'où elle peut être retirée après utilisation. Un manchon articulé (12) placé dans l'ouverture de l'élément de base (8) s'étend en dessous de ce dernier. Un élément de verrouillage vertical (14) est fixé entre l'élément de base (8) et le manchon (12) et vient se mettre en prise avec une butée (22) sur l'extrémité inférieure du moyen de positionnement (15) pour maintenir le dispositif en position de fonctionnement. La pression exercée sur le dessous du manchon articulé (12) déplace l'élément de verrouillage (14) pour le dégager de la butée (22) et assure le pivotement du bras de rappel (10) et de la lancette (23) vers le bas, dans le manchon articulé (12).
EP98955265A 1997-11-20 1998-11-20 Dispositif de prelevement par lancette appliquee par le patient lui-meme Ceased EP1032306A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AUPP046697 1997-11-20
AUPP0466A AUPP046697A0 (en) 1997-11-20 1997-11-20 Home lancet
PCT/AU1998/000961 WO1999026538A1 (fr) 1997-11-20 1998-11-20 Dispositif de prelevement par lancette appliquee par le patient lui-meme

Publications (2)

Publication Number Publication Date
EP1032306A1 true EP1032306A1 (fr) 2000-09-06
EP1032306A4 EP1032306A4 (fr) 2001-04-25

Family

ID=3804747

Family Applications (1)

Application Number Title Priority Date Filing Date
EP98955265A Ceased EP1032306A4 (fr) 1997-11-20 1998-11-20 Dispositif de prelevement par lancette appliquee par le patient lui-meme

Country Status (3)

Country Link
EP (1) EP1032306A4 (fr)
AU (2) AUPP046697A0 (fr)
WO (1) WO1999026538A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWM513008U (zh) * 2015-07-02 2015-12-01 Joinsoon Medical Technology Co Ltd 具退針裝置的高速採血筆
CN111887865A (zh) * 2020-06-05 2020-11-06 哈工大机器人(中山)无人装备与人工智能研究院 一种用于采血机器人的针带装置

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1599654A (en) * 1977-08-05 1981-10-07 Holman R R Automatic lancet
US4539988A (en) * 1983-07-05 1985-09-10 Packaging Corporation International Disposable automatic lancet
US4715374A (en) * 1986-11-14 1987-12-29 Medicore, Inc. Disposable automatic lancet
GB8710470D0 (en) * 1987-05-01 1987-06-03 Mumford Ltd Owen Blood sampling devices
US4844095A (en) * 1987-12-14 1989-07-04 Medicore, Inc. Automatic lancet device
US4983178A (en) * 1988-11-14 1991-01-08 Invictus, Inc. Lancing device
US5105823A (en) * 1990-04-05 1992-04-21 Blum Alvin S Shielded replaceable lancet blade assembly
AUPN689695A0 (en) * 1995-12-01 1995-12-21 Brakey, Dale Robert Blood letting device

Also Published As

Publication number Publication date
AUPP046697A0 (en) 1997-12-18
AU1219599A (en) 1999-06-15
WO1999026538A1 (fr) 1999-06-03
EP1032306A4 (fr) 2001-04-25

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