WO2005087102A1 - Blood collection device - Google Patents

Blood collection device Download PDF

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Publication number
WO2005087102A1
WO2005087102A1 PCT/AU2005/000347 AU2005000347W WO2005087102A1 WO 2005087102 A1 WO2005087102 A1 WO 2005087102A1 AU 2005000347 W AU2005000347 W AU 2005000347W WO 2005087102 A1 WO2005087102 A1 WO 2005087102A1
Authority
WO
WIPO (PCT)
Prior art keywords
cavity
needle
end portion
blood
needle structure
Prior art date
Application number
PCT/AU2005/000347
Other languages
French (fr)
Other versions
WO2005087102A8 (en
Inventor
Peter George Austin
Original Assignee
Von Pace Pty 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
Priority claimed from AU2004901349A external-priority patent/AU2004901349A0/en
Application filed by Von Pace Pty Ltd filed Critical Von Pace Pty Ltd
Publication of WO2005087102A1 publication Critical patent/WO2005087102A1/en
Publication of WO2005087102A8 publication Critical patent/WO2005087102A8/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
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A61B5/150641Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position
    • A61B5/150656Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves comprising means to impede repositioning of protection sleeve from covering to uncovering position semi-automatically triggered, i.e. in which the triggering of the protective sleeve requires a deliberate action by the user, e.g. manual release of spring-biased extension means
    • 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
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • 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
    • A61B5/150732Needle 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
    • 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
    • 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
    • A61M5/3221Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3227Constructional features thereof, e.g. to improve manipulation or functioning the needle being retracted laterally outside the syringe barrel, e.g. with separate guideway
    • 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
    • A61M2005/342Off-center needles, i.e. needle connections not being coaxial with the longitudinal symmetry axis of syringe barrel
    • 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
    • A61M5/3232Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means

Definitions

  • This invention relates to a blood collection device.
  • Blood may be withdrawn from a patient by use of a hollow needle which is, for example, inserted into a patient's vein so that blood flows through the needle to a suitable collection receptacle.
  • the needle After use, the needle is contaminated with the patient's blood, and disposal carries the usual problems associated with other "sharps" used in medical treatment, such as syringe needles.
  • One such problem is the possibility that diseases may be transmitted to others from the patient by contact with the blood of the patient due to accidental skin penetration by the needle after use.
  • a blood collection device comprising: a body with an internal cavity; a needle structure having a hollow needle which, in a condition of the device for use thereof, extends forwardly from the cavity and from the housing to a forward end of the needle for insertion of the forward end into a patient, an end portion of the needle structure, within the cavity, having an opening which in said condition is aligned with a passage of the device leading from said cavity so that blood, when passing into the needle from said forward end can pass via the end portion of the needle structure to said passage, said body having blood receptacle receiving means for receiving a blood receptacle so that, when so received, blood flowing into the passage can be passed to the receptacle; resilient means adapted to act between the body and the needle structure for urging the needle structure from said condition for use so that the needle is retracted into body; and a holding device adapted to hold the resilient means in a loaded condition and actuable to release the holding of the resilient means so that the resilient means effects said
  • the needle structure is preferably lengthwise slidable in the cavity, the passage opening to the cavity at a side location and, in said condition for use, being aligned with a side opening of the inner end portion of the needle structure, communicating with said needle.
  • the device preferably includes an O-ring seal mounted adjacent to the passage.
  • the inner end portion of the needle structure preferably has first and second sealing surfaces, the side opening being positioned between the sealing surfaces, and the sealing surfaces in said condition for use being sealingly engaged with sealing surfaces of the cavity, for inhibiting flow of blood from the side opening otherwise than to said passage.
  • the inner end portion and said cavity are preferably cylindrical, the cavity having forward, rearward and intermediate portions, the intermediate and rearward portions being of greater diameter than the forward portion and the rearward portion being of greater diameter than the intenriediate portion, one said sealing surface of the cavity being defined at an annular step between the forward and intermediate portions and the other said sealing surface of the cavity being defined at an annular step between the intermediate and rearward portions, a first said sealing surface of the inner end portion of the needle structure being defined at the periphery of a forward end of the inner end portion and a second of said sealing surfaces of the inner end portion being in the form of an annular surface extending outwardly at a location rearwardly disposed with respect to the first sealing surface of the inner end portion.
  • the resilient means is preferably a helical compression spring between a forward end of the cavity and said inner end portion of said needle structure.
  • the movable element is preferably slidable transversely of the cavity.
  • Fig. 1 is a lengthwise cross-section of a first embodiment of a blood collection device formed in accordance with the invention, in a condition for use;
  • Fig. 2 is a view like Fig. 1 but showing the blood collection device in use;
  • Fig. 3 is a view like Figs. 1 and 2, but showing the device after use, with a needle assembly thereof in a retracted condition;
  • Fig. 4 is an enlarged transverse scrap section on the line 4-4 in Fig. 1;
  • Fig. 5 is a view like Fig. 4 but illustrating a holding means of the device in a release condition
  • Fig. 6 is an enlarged scrap cross-section on the line 6-6 in Fig. 4;
  • Fig. 7 is a lengthwise cross-section of a second embodiment of a blood collection device formed in accordance with the invention, in a condition for use;
  • Fig. 8 is a transverse cross-section of the device shown in Fig. 7 on the line 8-8 in Fig. 7.
  • Figs. 1 to 6 show a first embodiment of a blood collection device 10 according to the invention.
  • the device 10 is designed for use with a blood collection receptacle 20 of standard form, which are well known in the art.
  • the receptacle 20 is formed as a hollow cylindrical body 22 closed at a rear end 24. At a forward end, the body 22 sealingly receives a resilient stopper 24.
  • a resilient sealing ring 27 extends around the circumference of the body 22 at the forward end thereof, ha the condition prior to use (Fig. 1) a central opening 26 through the stopper 24 is closed by a membrane 31.
  • the receptacle 20 is evacuated prior to use.
  • the membrane 31 is designed to be pierced by a hollow needle so that blood entering the needle at an end remote from the receptacle 20 is drawn into the receptacle 20, assisted by the pressure differential prevailing between the exterior of the receptacle 20 and the interior thereof.
  • the device 10 has a body 30 formed in two parts 32, 34.
  • the part 34 has a hollow cylindrical portion 36 open at a rear end and, at the forward end, a forwardly extending projection 38.
  • the body part 34 is retained on body part 32, the projection 38 being mechanically coupled to the body part 32 by engagement of the projection 38 in a mating opening 40 in the body part 32.
  • the projection 38 has an axial threaded bore 42 therethrough and threadedly receives a piercing device 44.
  • the device 44 has a forward end portion 46 which is sealingly engaged with the part 32 in a forward extension of the opening 40. From this location, the device 44 extends rearwardly with an exterior screw thread thereof threadedly engaged in threaded bore 42.
  • a needle 48 of the device 44 extends rearwardly and coaxially from the end portion 46 to project coaxially into the body 36 at the rear end thereof.
  • the needle 48 is protected by a resilient cover 145 which surrounds the needle 48 and extends rearwardly from the end portion 46.
  • the receptacle 20 is insertable into the body 36 of the part 34 by axial movement thereinto from the rear end such that the needle 48 penetrates the membrane 31 and passes through the opening 26 in stopper 24 so that the stopper 24 resiliently grips and seals against the external surface of the needle 48, and the end of the needle 48 is positioned within the receptacle 20. During this movement, the needle 48 also penetrates the resilient cover 145, which is then compressed by engagement with the stopper 24.
  • the inside diameter of the body 36 is dimensioned such that the sealing ring 27 sealingly engages the inner surface 50 thereof to provide an effective mechanical mounting and seal to the receptacle 20.
  • the piercing device 44 opens to an internal passage 52 within the body part 32.
  • the passage 52 opens sidewardly into a needle structure receiving cavity 60 formed in the body part 32.
  • the cavity 60 is generally cylindrical in form and is parallel to the body 36.
  • the cavity 60 receives a needle structure 70 having a needle 72 and an im er end portion 74.
  • the end portion 74 is formed of, for example, plastics material and is in the form of a cylindrical element having a forward cylindrical part 80 and a rear cylindrical part 82.
  • the part 82 is of greater diameter than part 80.
  • the end portion 74 of the needle structure 70 is wholly retained within the cavity 60, but the needle 72, in the condition of the needle structure shown in Figs. 1 and 2, extends coaxially forwardly of end portion 74 and forwardly from the body 30 via an opening 84 in a forward end wall 86 of the body part 32.
  • the cavity 60 is closed by a stopper 147.
  • the cavity 60 is formed of three coaxial portions 90, 92, 94 arranged in that order from a forward end of the device 10.
  • the portion 92 is of greater diameter than the portion 90 and the portion 94 is of greater diameter than the portion 92.
  • the forward cylindrical part 80 of the end portion 74 is of a diameter that is a sliding fit within the portion 92 of the cavity 60.
  • the rear cylindrical part 82 of the end portion 74 has a larger diameter, such that it is a sliding fit within the portion 94 of the cavity 60.
  • the parts 80, 82 are, in the condition of Fig. 1, accommodated within respective portions 92, 94 of cavity 60.
  • the needle structure 70 is slidably movable from this position but, as shown in Fig.
  • forward movement is limited by engagement of the parts 80, 82 with angled annular sealing surfaces 102, 104 respectively defined at the junctions between the portions 90, 92 and the portions 92, 94 of the cavity 60.
  • the part 80 of end portion 74 has, at its forward end, an angled annular sealing surface 106 which mates with surface 102 and, at a forward end of the part 82, there is an angled annular sealing surface 108 which mates with the surface 104.
  • the needle structure 70 is arranged such that a side opening 112 in the forward part 80 of the end portion 74 thereof is aligned with the internal passage 52 where this communicates with the cavity 60 (at the cavity portion 92) so as to be in fluid flow communication therewith.
  • An opening 112 communicates with the interior of the needle 72, at a rear end of the needle 72.
  • the needle structure 70 is resiliently biased rearwardly by a helical compression spring 190.
  • the spring 190 is positioned on the needle 72 between the end portion 74 and the forward end wall 86 of the body part 32. In the conditions shown in Figs. 1 and 2, however, the needle structure 70 is latched in the position shown, with spring 190 being in a compressed state (within cavity portion 90) and with the needle 72 extending forwardly from the body 30, by a holding device 138.
  • the holding device 138 has an element 142 carried by the part 32 and an element 144 in the form of a rear surface on the end portion 74 of the needle structure 70.
  • the element 142 is in the form of a depressible plunger having, as shown in Figs.
  • a shank portion 150 which is slidably mounted in a bore 152 in the part 32.
  • the bore 152 extends transversely of cavity 60, and is open to the cavity 60 at the portion 94 such that, in the condition shown in Figs. 1 and 2, the shank portion 150 extends immediately behind the end portion 74 so that the elements 142, 144 are in engagement, that is to say with the element 142 preventing rearward movement of the needle structure 70 by engagement with the element 144 defined by the rear surface of the end portion 74.
  • the element 142 is biased to this position by an internal helical compression spring 160 in the bore 152, but can however be depressed against that bias so that a cut-out portion 170 thereof is aligned with the cavity 60, this being such that the obstruction to rearward movement of the needle structure 70 under influence of spring 190 is released and the spring 190 causes the needle structure 70 to be moved rearwardly within the cavity 60 to the position shown in Fig. 3 in which the needle structure 70, including needle 72, is wholly retained within the cavity 60.
  • the element 142 may have a releasable lock element which prevents depression of element 142.
  • This lock element may take the form of a resilient clip 180 as shown in Fig. 6, this being in the nature of a circlip but which can nevertheless be manually moved off the shank portion 150 by sidewards movements so that the shank portion 150 passes through a narrow portion of the clip 180, under resilient deformation of the clip 180.
  • the clip 180 when positioned on the shank portion 150, prevents inward movement of the shank portion 150, being interposed between the external surface of the body part 32 and an underside surface of an outer end button portion 162 of the element 142.
  • the clip 180 is preferably arranged such that it can be removed by finger pressure, particularly by outwards separation of free ends 182, 184 of the clip 180.
  • the device 10 is placed, in the loaded condition shown in Fig. 1, with the needle 72 extending forwardly from the body 30.
  • the needle 72 is then positioned in a patient 182 so as to be in fluid flow communication with a vein whereupon blood from the patient flows through the needle 72 into the passage 52 and thence from the needle 48.
  • the receptacle 20 is placed in position as described (Fig. 2). Blood then flows into the receptacle 20 via the needle 48.
  • the receptacle may be removed, and the needle 72 withdrawn from the patient by actuation of the holding device 138.
  • the needle structure 70 is as described drawn into the cavity 60 under action of the spring 190 for retention therein. The needle 72 is thus no longer exposed, thereby minimising the probability of a needle stick injury or the like.
  • Figs. 7 and 8 show a second embodiment of a blood collection device 210 according to the invention. Like features in the device 210 to those previously described in relation to the device 10 are indicated with like reference numerals.
  • the body parts 32 and 34 are integrally formed in the device 210.
  • the device 210 also has an O-ring seal 212 between the opening 112 in the needle structure 70 and the passage 52 in the body part 32.
  • the O- ring 212 being mounted in the body part 32.
  • the device 210 functions in a similar manner to that as described in relation to the device 210.
  • the holding device 138 is situated forwardly of the blood transfer passage 52 in order to minimise the possibility of contaminated blood splattering the operator during retraction of the needle 72 and the associated end portion 74.

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

Abstract

A blood collection device (10) having a body (30) with an internal cavity (60) and a needle structure (70) having a hollow needle (70) which, in a condition of the device (10) for use thereof, extends forwardly from the cavity (60) and from the body (22) to a forward end of the needle for insertion of the forward end into a patient (182). An end portion (74) of the needle structure (70), within the cavity (60), has an opening (112) which in said condition is aligned with a passage (52) of the device (10) leading from said cavity (60) so that blood, when passing into the needle (70) from said forward end can pass via the end portion (74) of the needle structure (70), to said passage (52). The body (22) has blood receptacle receiving means (50) for receiving a blood receptacle (20) so that, when so received, blood flowing into the passage (52) can be passed to the receptacle (20). The device (10) also has resilient means (90), acting between the body (30) and the needle structure (70), for urging the needle structure from said condition for use so that the needle (72) is retracted into body (30), and a holding device (138) holding the resilient means (90) in a loaded condition and actuable to release the holding of the resilient means (90) so that the resilient means (90) effects said retraction.

Description

BLOOD COLLECTION DEVICE
Field of the Invention
This invention relates to a blood collection device.
Background of the Invention Blood may be withdrawn from a patient by use of a hollow needle which is, for example, inserted into a patient's vein so that blood flows through the needle to a suitable collection receptacle. After use, the needle is contaminated with the patient's blood, and disposal carries the usual problems associated with other "sharps" used in medical treatment, such as syringe needles. One such problem is the possibility that diseases may be transmitted to others from the patient by contact with the blood of the patient due to accidental skin penetration by the needle after use.
It is an object of the present invention to provide a blood collection device that minimizes the likelihood of the problems discussed above.
Summary of the Invention
According to the present invention, there is provided a blood collection device comprising: a body with an internal cavity; a needle structure having a hollow needle which, in a condition of the device for use thereof, extends forwardly from the cavity and from the housing to a forward end of the needle for insertion of the forward end into a patient, an end portion of the needle structure, within the cavity, having an opening which in said condition is aligned with a passage of the device leading from said cavity so that blood, when passing into the needle from said forward end can pass via the end portion of the needle structure to said passage, said body having blood receptacle receiving means for receiving a blood receptacle so that, when so received, blood flowing into the passage can be passed to the receptacle; resilient means adapted to act between the body and the needle structure for urging the needle structure from said condition for use so that the needle is retracted into body; and a holding device adapted to hold the resilient means in a loaded condition and actuable to release the holding of the resilient means so that the resilient means effects said retraction. The holding device may include a movable element which, in said condition for use, engages the end portion of needle structure, to prevent said retraction but is movable to release said engagement.
The needle structure is preferably lengthwise slidable in the cavity, the passage opening to the cavity at a side location and, in said condition for use, being aligned with a side opening of the inner end portion of the needle structure, communicating with said needle.
The device preferably includes an O-ring seal mounted adjacent to the passage.
The inner end portion of the needle structure preferably has first and second sealing surfaces, the side opening being positioned between the sealing surfaces, and the sealing surfaces in said condition for use being sealingly engaged with sealing surfaces of the cavity, for inhibiting flow of blood from the side opening otherwise than to said passage.
The inner end portion and said cavity are preferably cylindrical, the cavity having forward, rearward and intermediate portions, the intermediate and rearward portions being of greater diameter than the forward portion and the rearward portion being of greater diameter than the intenriediate portion, one said sealing surface of the cavity being defined at an annular step between the forward and intermediate portions and the other said sealing surface of the cavity being defined at an annular step between the intermediate and rearward portions, a first said sealing surface of the inner end portion of the needle structure being defined at the periphery of a forward end of the inner end portion and a second of said sealing surfaces of the inner end portion being in the form of an annular surface extending outwardly at a location rearwardly disposed with respect to the first sealing surface of the inner end portion.
The resilient means is preferably a helical compression spring between a forward end of the cavity and said inner end portion of said needle structure.
The movable element is preferably slidable transversely of the cavity.
Brief description of the drawings
Preferred embodiments of the invention will now be described, by way of examples only, with reference to the accompanying drawings, in which: Fig. 1 is a lengthwise cross-section of a first embodiment of a blood collection device formed in accordance with the invention, in a condition for use;
Fig. 2 is a view like Fig. 1 but showing the blood collection device in use;
Fig. 3 is a view like Figs. 1 and 2, but showing the device after use, with a needle assembly thereof in a retracted condition;
Fig. 4 is an enlarged transverse scrap section on the line 4-4 in Fig. 1;
Fig. 5 is a view like Fig. 4 but illustrating a holding means of the device in a release condition;
Fig. 6 is an enlarged scrap cross-section on the line 6-6 in Fig. 4;
Fig. 7 is a lengthwise cross-section of a second embodiment of a blood collection device formed in accordance with the invention, in a condition for use; and
Fig. 8 is a transverse cross-section of the device shown in Fig. 7 on the line 8-8 in Fig. 7.
Detailed description of the preferred embodiments
Figs. 1 to 6 show a first embodiment of a blood collection device 10 according to the invention. The device 10 is designed for use with a blood collection receptacle 20 of standard form, which are well known in the art. The receptacle 20 is formed as a hollow cylindrical body 22 closed at a rear end 24. At a forward end, the body 22 sealingly receives a resilient stopper 24. A resilient sealing ring 27 extends around the circumference of the body 22 at the forward end thereof, ha the condition prior to use (Fig. 1) a central opening 26 through the stopper 24 is closed by a membrane 31. The receptacle 20 is evacuated prior to use. As described later, the membrane 31 is designed to be pierced by a hollow needle so that blood entering the needle at an end remote from the receptacle 20 is drawn into the receptacle 20, assisted by the pressure differential prevailing between the exterior of the receptacle 20 and the interior thereof. The device 10 has a body 30 formed in two parts 32, 34. The part 34 has a hollow cylindrical portion 36 open at a rear end and, at the forward end, a forwardly extending projection 38.
The body part 34 is retained on body part 32, the projection 38 being mechanically coupled to the body part 32 by engagement of the projection 38 in a mating opening 40 in the body part 32. The projection 38 has an axial threaded bore 42 therethrough and threadedly receives a piercing device 44. The device 44 has a forward end portion 46 which is sealingly engaged with the part 32 in a forward extension of the opening 40. From this location, the device 44 extends rearwardly with an exterior screw thread thereof threadedly engaged in threaded bore 42. A needle 48 of the device 44 extends rearwardly and coaxially from the end portion 46 to project coaxially into the body 36 at the rear end thereof. The needle 48 is protected by a resilient cover 145 which surrounds the needle 48 and extends rearwardly from the end portion 46.
The receptacle 20 is insertable into the body 36 of the part 34 by axial movement thereinto from the rear end such that the needle 48 penetrates the membrane 31 and passes through the opening 26 in stopper 24 so that the stopper 24 resiliently grips and seals against the external surface of the needle 48, and the end of the needle 48 is positioned within the receptacle 20. During this movement, the needle 48 also penetrates the resilient cover 145, which is then compressed by engagement with the stopper 24.
The inside diameter of the body 36 is dimensioned such that the sealing ring 27 sealingly engages the inner surface 50 thereof to provide an effective mechanical mounting and seal to the receptacle 20.
At a forward end, the piercing device 44 opens to an internal passage 52 within the body part 32. The passage 52 opens sidewardly into a needle structure receiving cavity 60 formed in the body part 32. The cavity 60 is generally cylindrical in form and is parallel to the body 36. The cavity 60 receives a needle structure 70 having a needle 72 and an im er end portion 74. The end portion 74 is formed of, for example, plastics material and is in the form of a cylindrical element having a forward cylindrical part 80 and a rear cylindrical part 82. The part 82 is of greater diameter than part 80. The end portion 74 of the needle structure 70 is wholly retained within the cavity 60, but the needle 72, in the condition of the needle structure shown in Figs. 1 and 2, extends coaxially forwardly of end portion 74 and forwardly from the body 30 via an opening 84 in a forward end wall 86 of the body part 32. At the rear end, the cavity 60 is closed by a stopper 147.
The cavity 60 is formed of three coaxial portions 90, 92, 94 arranged in that order from a forward end of the device 10. The portion 92 is of greater diameter than the portion 90 and the portion 94 is of greater diameter than the portion 92. The forward cylindrical part 80 of the end portion 74 is of a diameter that is a sliding fit within the portion 92 of the cavity 60. The rear cylindrical part 82 of the end portion 74 has a larger diameter, such that it is a sliding fit within the portion 94 of the cavity 60. As shown, the parts 80, 82 are, in the condition of Fig. 1, accommodated within respective portions 92, 94 of cavity 60. The needle structure 70 is slidably movable from this position but, as shown in Fig. 1, forward movement is limited by engagement of the parts 80, 82 with angled annular sealing surfaces 102, 104 respectively defined at the junctions between the portions 90, 92 and the portions 92, 94 of the cavity 60. More particularly, the part 80 of end portion 74 has, at its forward end, an angled annular sealing surface 106 which mates with surface 102 and, at a forward end of the part 82, there is an angled annular sealing surface 108 which mates with the surface 104.
Also, in the conditions shown in Figs. 1 and 2, the needle structure 70 is arranged such that a side opening 112 in the forward part 80 of the end portion 74 thereof is aligned with the internal passage 52 where this communicates with the cavity 60 (at the cavity portion 92) so as to be in fluid flow communication therewith. An opening 112 communicates with the interior of the needle 72, at a rear end of the needle 72.
The needle structure 70 is resiliently biased rearwardly by a helical compression spring 190. The spring 190 is positioned on the needle 72 between the end portion 74 and the forward end wall 86 of the body part 32. In the conditions shown in Figs. 1 and 2, however, the needle structure 70 is latched in the position shown, with spring 190 being in a compressed state (within cavity portion 90) and with the needle 72 extending forwardly from the body 30, by a holding device 138. The holding device 138 has an element 142 carried by the part 32 and an element 144 in the form of a rear surface on the end portion 74 of the needle structure 70. The element 142 is in the form of a depressible plunger having, as shown in Figs. 4 and 5, a shank portion 150 which is slidably mounted in a bore 152 in the part 32. The bore 152 extends transversely of cavity 60, and is open to the cavity 60 at the portion 94 such that, in the condition shown in Figs. 1 and 2, the shank portion 150 extends immediately behind the end portion 74 so that the elements 142, 144 are in engagement, that is to say with the element 142 preventing rearward movement of the needle structure 70 by engagement with the element 144 defined by the rear surface of the end portion 74. The element 142 is biased to this position by an internal helical compression spring 160 in the bore 152, but can however be depressed against that bias so that a cut-out portion 170 thereof is aligned with the cavity 60, this being such that the obstruction to rearward movement of the needle structure 70 under influence of spring 190 is released and the spring 190 causes the needle structure 70 to be moved rearwardly within the cavity 60 to the position shown in Fig. 3 in which the needle structure 70, including needle 72, is wholly retained within the cavity 60.
To prevent accidental operation of the holding device 138, the element 142 may have a releasable lock element which prevents depression of element 142. This lock element may take the form of a resilient clip 180 as shown in Fig. 6, this being in the nature of a circlip but which can nevertheless be manually moved off the shank portion 150 by sidewards movements so that the shank portion 150 passes through a narrow portion of the clip 180, under resilient deformation of the clip 180. The clip 180, when positioned on the shank portion 150, prevents inward movement of the shank portion 150, being interposed between the external surface of the body part 32 and an underside surface of an outer end button portion 162 of the element 142. The clip 180 is preferably arranged such that it can be removed by finger pressure, particularly by outwards separation of free ends 182, 184 of the clip 180.
In use, the device 10 is placed, in the loaded condition shown in Fig. 1, with the needle 72 extending forwardly from the body 30. As shown in Fig. 2, the needle 72 is then positioned in a patient 182 so as to be in fluid flow communication with a vein whereupon blood from the patient flows through the needle 72 into the passage 52 and thence from the needle 48. When it has been ascertained that blood flow is occurring, the receptacle 20 is placed in position as described (Fig. 2). Blood then flows into the receptacle 20 via the needle 48. After filling the receptacle 20, the receptacle may be removed, and the needle 72 withdrawn from the patient by actuation of the holding device 138. By the latter, the needle structure 70 is as described drawn into the cavity 60 under action of the spring 190 for retention therein. The needle 72 is thus no longer exposed, thereby minimising the probability of a needle stick injury or the like.
Figs. 7 and 8 show a second embodiment of a blood collection device 210 according to the invention. Like features in the device 210 to those previously described in relation to the device 10 are indicated with like reference numerals. The body parts 32 and 34 are integrally formed in the device 210. The device 210 also has an O-ring seal 212 between the opening 112 in the needle structure 70 and the passage 52 in the body part 32. The O- ring 212 being mounted in the body part 32.
The device 210 functions in a similar manner to that as described in relation to the device 210. However, in the device 10, the holding device 138 is situated forwardly of the blood transfer passage 52 in order to minimise the possibility of contaminated blood splattering the operator during retraction of the needle 72 and the associated end portion 74.
The described anangement has been advanced merely by way of explanation any many modifications may be made thereto without departing from the spirit and scope of the invention which includes every novel feature and combination of novel features herein disclosed.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.
The reference to any prior art in this specification is not, and should not be taken as, an acknowledgment or any form of suggestion that that prior art forms part of the common general knowledge in Australia.

Claims

Claims
1. A blood collection device comprising: a body with an internal cavity; a needle structure having a hollow needle which, in a condition of the device for use thereof, extends forwardly from the cavity and from the housing to a forward end of the needle for insertion of the forward end into a patient, an end portion of the needle structure, within the cavity, having an opening which in said condition is aligned with a passage of the device leading from said cavity so that blood, when passing into the needle from said forward end can pass via the end portion of the needle structure to said passage, said body having blood receptacle receiving means for receiving a blood receptacle so that, when so received, blood flowing into the passage can be passed to the receptacle; resilient means adapted to act between the body and the needle structure for urging the needle structure from said condition for use so that the needle is retracted into the body; and a holding device adapted to hold the resilient means in a loaded condition and actuable to release the holding of the resilient means so that the resilient means effects said retraction.
2. The blood collection device as claimed in claim 1, wherein the holding device includes a movable element which, in said condition for use, engages the end portion of the needle structure, to prevent said retraction, but is movable to release said engagement and allow said retraction.
3. The blood collection device as claimed in claim 1 or claim 2, wherein the needle structure is lengthwise slidable in the cavity, the passage opening to the cavity at a side location and, in said condition for use, being aligned with a side opening of the inner end portion of the needle structure, communicating with said needle.
4. The blood collection device as claimed in claim 3, further including an O-ring seal mounted adjacent the passage.
5. The blood collection device as claimed in claims 3 or 4, wherein the inner end portion of the needle structure has first and second sealing surfaces, the side opening being positioned between the sealing surfaces, and the sealing surfaces in said condition for use being sealingly engaged with sealing surfaces of the cavity, for inhibiting flow of blood from the side opening otherwise than to said passage.
6. The blood collection device as claimed in claim 3, wherein said inner end portion and said cavity are cylindrical, the cavity having forward, rearward and intermediate portions, the intermediate and rearward portions being of greater diameter than the forward portion and the rearward portion being of greater diameter than the intermediate portion, one said sealing surface of the cavity being defined at an annular step between the forward and intermediate portions and the other said sealing surface of the cavity being defined at an annular step between the intermediate and rearward portions, a first said sealing surface of the inner end portion of the needle structure being defined at the periphery of a forward end of the inner end portion and a second of said sealing surfaces of the inner end portion being in the form of an annular surface extending outwardly at a location rearwardly disposed with respect to the first sealing surface of the inner end portion.
7. The blood collection device as claimed in any one of the preceding claims, wherein said resilient means is a helical compression spring between a forward end of the cavity and said inner end portion of said needle structure.
8. The blood collection device as claimed in any one of claims 2 to 6, wherein said movable element is slidable transversely of the cavity.
9. A blood collection device substantially as hereinbefore described with reference to Figs. 1 to 6 or Figs. 7 and 8 of the accompanying drawings.
PCT/AU2005/000347 2004-03-15 2005-03-14 Blood collection device WO2005087102A1 (en)

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Application Number Priority Date Filing Date Title
AU2004901349A AU2004901349A0 (en) 2004-03-15 Blood Collection Device
AU2004901349 2004-03-15

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WO2005087102A8 WO2005087102A8 (en) 2005-11-24

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ITRM20110338A1 (en) * 2011-06-27 2012-12-28 Mauro Pepe HOLDER WITH COLLECTION CHAMBER FOR WITHDRAWAL EMATICS.
JP2016503675A (en) * 2012-12-14 2016-02-08 リトラクタブル テクノロジーズ, インコーポレイテッドRetractable Technologies, Inc. Needle retractor
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WO2007131282A1 (en) * 2006-05-17 2007-11-22 Eastland Medical Systems Ltd Attachment for a parenteral device
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ITRM20110338A1 (en) * 2011-06-27 2012-12-28 Mauro Pepe HOLDER WITH COLLECTION CHAMBER FOR WITHDRAWAL EMATICS.
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KR20190022854A (en) * 2016-07-05 2019-03-06 리트렉터블 테크놀로지스 인코포레이티드 Blood collection tube holder with slide-action needle retraction
JP2019524210A (en) * 2016-07-05 2019-09-05 リトラクタブル テクノロジーズ, インコーポレイテッドRetractable Technologies, Inc. Blood collection tube holder with needle retractable slide operation
US20180008180A1 (en) * 2016-07-05 2018-01-11 Thomas J. Shaw Blood Collection Tube Holder with Discharge Needle Displacement Member
US11000217B2 (en) * 2016-07-05 2021-05-11 Retractable Technologies, Inc. Blood collection tube holder with discharge needle displacement member
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JP6998330B2 (en) 2016-07-05 2022-01-18 リトラクタブル テクノロジーズ,インコーポレイテッド Blood collection tube holder with slide-actuated needle pull-in
TWI764907B (en) * 2016-07-05 2022-05-21 美商伸縮科技股份有限公司 Blood collection tube holder with slide-activated needle retraction
KR102455137B1 (en) 2016-07-05 2022-10-17 리트렉터블 테크놀로지스 인코포레이티드 Blood Collection Tube Holder with Slide Actuated Needle Retraction

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