WO2005092174A1 - A needle assembly for a body fluids sampling device - Google Patents

A needle assembly for a body fluids sampling device Download PDF

Info

Publication number
WO2005092174A1
WO2005092174A1 PCT/GB2005/001061 GB2005001061W WO2005092174A1 WO 2005092174 A1 WO2005092174 A1 WO 2005092174A1 GB 2005001061 W GB2005001061 W GB 2005001061W WO 2005092174 A1 WO2005092174 A1 WO 2005092174A1
Authority
WO
WIPO (PCT)
Prior art keywords
hub
needle assembly
needles
passageway
needle
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
PCT/GB2005/001061
Other languages
English (en)
French (fr)
Inventor
Peter Jeffrey
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.)
Safe T Ltd
Original Assignee
Safe T 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 Safe T Ltd filed Critical Safe T Ltd
Priority to JP2007504462A priority Critical patent/JP2007530115A/ja
Priority to EP05729445A priority patent/EP1734857A1/en
Priority to CA002558527A priority patent/CA2558527A1/en
Priority to AU2005226942A priority patent/AU2005226942A1/en
Publication of WO2005092174A1 publication Critical patent/WO2005092174A1/en
Priority to US11/523,836 priority patent/US20070088229A1/en
Anticipated expiration legal-status Critical
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
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • A61B5/1545Devices using pre-evacuated means comprising means for indicating vein or arterial entry
    • 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
    • A61B5/15003Source of blood for venous or arterial blood
    • 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
    • A61B5/150297Manufacture or production processes or steps for blood sampling devices for piercing devices, i.e. devices ready to be used for lancing or piercing
    • 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
    • A61B5/150389Hollow piercing elements, e.g. canulas, needles, 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
    • A61B5/150473Double-ended needles, e.g. used with pre-evacuated sampling tubes
    • A61B5/150496Details of construction of hub, i.e. element used to attach the double-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
    • A61B5/150381Design of piercing elements
    • A61B5/150526Curved or bent needles
    • 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
    • A61B5/150572Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
    • 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
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • 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
    • A61B5/150732Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user
    • A61M2005/3235Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user triggered by radial deflection of the anchoring parts between needle mount and syringe barrel or needle housing, e.g. spreading of needle mount retaining hooks having slanted surfaces by engagement with correspondingly shaped surfaces on the piston at the end of an injection stroke
    • A61M2005/3236Trigger provided at the distal end, i.e. syringe end for mounting a needle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M2005/341Constructions for connecting the needle, e.g. to syringe nozzle or needle hub angularly adjustable or angled away from the axis of the injector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/322Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
    • A61M5/3234Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user

Definitions

  • the needle is withdrawn from the vein and the sampler is either discarded, or alternatively, if the sampler is mounted in a syringe body as described in our earlier patent specification EP-A-0648136, it is automatically retracted under spring bias into the syringe body.
  • the housing provides a passageway between the two needles and has a chamber therein with transparent walls through which the presence or absence of a blood sample will be visually apparent.
  • the housing is formed of two parts which fit together so that one projects into the other and an annular space is defined between the parts which provides the chamber for viewing the presence of a sample. A relatively large initial volume of any sample is bled off into the annular chamber, and this can only be accomplished by venting air from the chamber.
  • a needle assembly for a body fluids sampling device which comprises first and second hollow needles extending from opposing sides of a common hub, the proximal ends of the respective needles being in communication with each other by a passageway through the hub which is provided with a transparent window, whereby the passageway is visible, characterised in that the hub is formed in one piece and of transparent material.
  • a patient's blood pressure will be sufficient to force some blood into the hollow needle used to pierce the vein and into the connecting duct between the proximal ends of the respective needles, where it can be viewed through the surrounding transparent material.
  • the passageway or duct between the proximal ends of the respective needles is kept as short and as narrow as is feasible.
  • needles conventionally used in blood sampling devices may have an outer diameter (OD) of about 0.9 to 1.0mm
  • the passageway between the needle ends may be as little as 0.8mm wide in many embodiments of the present invention. Only the end sections of the passageway where end regions of the needles are accommodated need to be equal to the OD of the needles.
  • the needle assembly of the invention (also referred to herein as a sampler device) is not limited to blood sampling, although that is likely to be its primarily application, and could be used or adapted for use in sampling other body fluids of human or animal origin.
  • the needle intended to enter the patient's vein may be offset from the axis of the device, whereas the needle intended to enter the collection tube will need to remain in an axial disposition so as to pierce the septum of the collection tube centrally, at its weakest position, as the hub fits into the neck of the tube.
  • Fig. 5 is a side elevation, also similar to Fig. 2, of a fourth practical embodiment of a needle assembly according to the present invention.
  • the first needle 101 has, at one end, a multi-ground point 201 for penetration of a patients' skin and vein wall, while its other end 202 is plain and is bonded to the hub 107.
  • the second needle 102 also has a ground point 203 at its free end, which is for piercing of a septum of a pre-evacuated blood sampling tube (not shown).
  • the cover 118 would also be pierced in that operation.
  • the other end 204 of the second needle 102 is also plain and is also bonded to the hub 107.
  • substantially all of the hub 107, including all of the magnifier formation 104, may be located inside a transparent syringe body 300 with acceptable visibility of the witnessing duct 113.
  • a second embodiment of the invention is an offset witnessing multi-sample needle assembly 20.
  • the same reference numerals are used to designate parts which correspond to those of the first embodiment and these will not be described again.
  • the passageway through the hub 107 consists of the aforesaid axially offset portions 108, 109, which lie substantially parallel to each other but extend in from opposing sides of the hub, and a transverse bridging portion 105 which connects these two offset portions 108, 109.
  • the offset portions 108, 109 of the passageway are formed as blind bores from opposing sides of the hub 107.
  • Each has a narrower inner end region delimited by a respective shoulder 208, 209 which serves to limit insertion of the proximal ends 202, 204 of the respective needles 101, 102 during manufacture.
  • the needles 101, 102 are bonded to the hub 107 once inserted.
  • the bridging portion 105 of the passageway extends between and substantially perpendicular to the narrower inner end regions of the offset portions 108, 109 of the passageway.
  • the hub 107 is manufactured in one piece by injection moulding and the bridging portion 105 is formed during moulding by use of a sliding core. When the core is withdrawn the bridging portion 105 initially extends to, i.e. is open to, the outside of the hub 107. The open end may be sealed off by a plug 106, which may suitably be formed of polypropylene and may be a simple push fit therein.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Hematology (AREA)
  • Biophysics (AREA)
  • Pathology (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)
  • Manufacturing & Machinery (AREA)
  • Vascular Medicine (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
PCT/GB2005/001061 2004-03-23 2005-03-22 A needle assembly for a body fluids sampling device Ceased WO2005092174A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2007504462A JP2007530115A (ja) 2004-03-23 2005-03-22 体液試料採取器具用の針アセンブリ
EP05729445A EP1734857A1 (en) 2004-03-23 2005-03-22 A needle assembly for a body fluids sampling device
CA002558527A CA2558527A1 (en) 2004-03-23 2005-03-22 A needle assembly for a body fluids sampling device
AU2005226942A AU2005226942A1 (en) 2004-03-23 2005-03-22 A needle assembly for a body fluids sampling device
US11/523,836 US20070088229A1 (en) 2004-03-23 2006-09-20 Needle assembly for a blood sampling device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0406438.2A GB0406438D0 (en) 2004-03-23 2004-03-23 A needle assembly for a body fluids sampling device
GB0406438.2 2004-03-23

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US11/523,836 Continuation-In-Part US20070088229A1 (en) 2004-03-23 2006-09-20 Needle assembly for a blood sampling device

Publications (1)

Publication Number Publication Date
WO2005092174A1 true WO2005092174A1 (en) 2005-10-06

Family

ID=32188474

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2005/001061 Ceased WO2005092174A1 (en) 2004-03-23 2005-03-22 A needle assembly for a body fluids sampling device

Country Status (7)

Country Link
US (1) US20070088229A1 (enExample)
EP (1) EP1734857A1 (enExample)
JP (1) JP2007530115A (enExample)
AU (1) AU2005226942A1 (enExample)
CA (1) CA2558527A1 (enExample)
GB (1) GB0406438D0 (enExample)
WO (1) WO2005092174A1 (enExample)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2042089A1 (en) 2007-09-27 2009-04-01 Tyco Healthcare Group LP Blood collection needle assembly
CN104470437A (zh) * 2012-09-03 2015-03-25 张建铭 针筒式真空采血器的针座组件

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP4966776B2 (ja) * 2007-07-24 2012-07-04 積水化学工業株式会社 採血ホルダー
KR20120103661A (ko) * 2009-12-28 2012-09-19 스탠리 킴 무통 피하주사 바늘
CN104470438B (zh) * 2012-08-02 2017-01-25 张建铭 针筒式真空采血器
CN104470432B (zh) * 2012-08-02 2016-10-12 张建铭 具有针尖保护的针筒式真空采血器
CN105105770B (zh) * 2015-09-25 2017-08-22 温州京环科技有限公司 一种可见回血采血针
IT201900001685A1 (it) * 2019-02-06 2020-08-06 Sol Millennium Swiss R&D Center Sa Dispositivo medico con cannula disassata
US11793984B2 (en) * 2020-07-20 2023-10-24 Becton, Dickinson And Company Vascular access instrument and related devices and methods

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3491748A (en) * 1967-03-20 1970-01-27 Albert F Pate Vacuum blood drawing device
GB2029228A (en) * 1977-08-10 1980-03-19 Becton Dickinson Co Improvements in and relating to blood collection systems
US4444203A (en) * 1982-03-26 1984-04-24 Lab-A-Cath, Inc. Intravenous catheter placing and specimen gathering device
US5137518A (en) * 1990-11-02 1992-08-11 Becton, Dickinson And Company Instantaneous vein entry indicator for intravenous needle
US5450856A (en) * 1994-04-25 1995-09-19 Norris; Wendal A. Phlebotomy needle attachable to a vacuum container with a vent to preclude blood flashback
US20010044615A1 (en) * 2000-05-16 2001-11-22 Fuji Photo Film Co., Ltd. Plasma collecting device
US20040024369A1 (en) * 2000-06-13 2004-02-05 Christopher Clarke Phlebotomy device

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4679571A (en) * 1984-08-31 1987-07-14 Becton, Dickinson And Company Blood sample needle assembly with vein indicator
US6063040A (en) * 1998-01-16 2000-05-16 Specialized Health Products, Inc. Self retracting needle apparatus and method for phlebotomy
FR2780628B1 (fr) * 1998-07-03 2000-12-15 Altair Dispositif de prelevement sanguin a tube sous vide
US6712792B2 (en) * 2001-05-02 2004-03-30 Becton, Dickinson And Company Flashback blood collection needle
US6974423B2 (en) * 2002-03-11 2005-12-13 Becton, Dickinson And Company Needle assembly

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3491748A (en) * 1967-03-20 1970-01-27 Albert F Pate Vacuum blood drawing device
GB2029228A (en) * 1977-08-10 1980-03-19 Becton Dickinson Co Improvements in and relating to blood collection systems
US4444203A (en) * 1982-03-26 1984-04-24 Lab-A-Cath, Inc. Intravenous catheter placing and specimen gathering device
US5137518A (en) * 1990-11-02 1992-08-11 Becton, Dickinson And Company Instantaneous vein entry indicator for intravenous needle
US5450856A (en) * 1994-04-25 1995-09-19 Norris; Wendal A. Phlebotomy needle attachable to a vacuum container with a vent to preclude blood flashback
US20010044615A1 (en) * 2000-05-16 2001-11-22 Fuji Photo Film Co., Ltd. Plasma collecting device
US20040024369A1 (en) * 2000-06-13 2004-02-05 Christopher Clarke Phlebotomy device

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2042089A1 (en) 2007-09-27 2009-04-01 Tyco Healthcare Group LP Blood collection needle assembly
US9066690B2 (en) 2007-09-27 2015-06-30 Covidien Lp Blood collection needle assembly
CN104470437A (zh) * 2012-09-03 2015-03-25 张建铭 针筒式真空采血器的针座组件
CN104470437B (zh) * 2012-09-03 2016-09-14 张建铭 针筒式真空采血器的针座组件

Also Published As

Publication number Publication date
GB0406438D0 (en) 2004-04-28
JP2007530115A (ja) 2007-11-01
AU2005226942A1 (en) 2005-10-06
US20070088229A1 (en) 2007-04-19
CA2558527A1 (en) 2005-10-06
EP1734857A1 (en) 2006-12-27

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