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WO2013191659A1 - Seringue modifiée - Google Patents

Seringue modifiée Download PDF

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Publication number
WO2013191659A1
WO2013191659A1 PCT/SG2013/000257 SG2013000257W WO2013191659A1 WO 2013191659 A1 WO2013191659 A1 WO 2013191659A1 SG 2013000257 W SG2013000257 W SG 2013000257W WO 2013191659 A1 WO2013191659 A1 WO 2013191659A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
syringe
syringe according
barrel
sample
Prior art date
Application number
PCT/SG2013/000257
Other languages
English (en)
Inventor
Beng Teck See
Original Assignee
Beng Teck See
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 Beng Teck See filed Critical Beng Teck See
Publication of WO2013191659A1 publication Critical patent/WO2013191659A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
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    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150251—Collection chamber divided into at least two compartments, e.g. for division of samples
    • A—HUMAN NECESSITIES
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    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A61B5/150519—Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
    • A—HUMAN NECESSITIES
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    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150587—Joining techniques used for protective means by friction fit
    • A—HUMAN NECESSITIES
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058—Joining techniques used for protective means
    • A61B5/150603—Joining techniques used for protective means by rotation, e.g. bayonet or screw
    • A—HUMAN NECESSITIES
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    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694—Procedure for removing protection means at the time of piercing
    • A61B5/150717—Procedure for removing protection means at the time of piercing manually removed
    • A—HUMAN NECESSITIES
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    • A61B5/150007—Details
    • A61B5/150732—Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube
    • A—HUMAN NECESSITIES
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    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150885—Preventing re-use
    • A61B5/150908—Preventing re-use by disconnecting components, e.g. breaking or rupturing of connected parts, e.g. piston and rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A61M5/3134—Syringe barrels characterised by constructional features of the distal end, i.e. end closest to the tip of the needle cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150259—Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A61J1/062—Carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1425—Snap-fit type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2205/00—General identification or selection means
    • A61J2205/30—Printed labels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets
    • A61M5/345—Adaptors positioned between needle hub and syringe nozzle

Definitions

  • the invention relates to a syringe for extracting body fluid samples.
  • Blood testing can provide important data representative of a plethora of clinical signs and symptoms, thereby facilitating diagnosis and subsequently timely treatment.
  • blood tests determine physiological and biochemical indices of the body, for example, body mineral or metabolite (or electrolyte) content, oxygen and carbon dioxide levels, drug effectiveness, and also organ function. Furthermore, blood tests are commonly used as a form of drug or alcohol testing. Blood tests are also a way to obtain a DNA sample for genetic testing and screening, for example, to diagnose genetic conditions, or even to undertake forensic examinations.
  • the most common blood test performed on a patient is the full blood count, a test wherein the key components of the blood (leukocytes, erythrocytes and thrombocytes) are counted to predict a patient's general state of health. More definitive blood tests include kidney or liver function tests, blood glucose or cholesterol level tests, blood clotting tests, allergy tests and blood grouping.
  • blood test most routine tests (except for most haematology) are performed on the blood plasma component of the blood instead of on the blood cells. Depending upon the nature of the test, most commonly a single blood sample is taken. However, some blood tests require several samples to be taken over a period of time, for example, to assess the effectiveness or duration of an administered drug.
  • a sample of blood is most often taken from a patient by venepuncture, wherein a minor-invasive incision is made in the skin in an attempt to obtain intravenous access. Most commonly, this involves taking a sample of blood from a vein in the arm, the median cubital vein, which lies within the cubital fossa anterior to the elbow. This vein lies close to the surface of the skin with little nerve supply, and consequently its puncture is relatively painless. The procedure involves the application of a tourniquet 3-4 inches above the selected puncture site to reduce the blood flow and increase vein visibility.
  • a needle attached to a syringe or specialised collection vessel, is inserted through the skin and into the lumen of the vein to-ex1:raeHhe-blood7-Once-an-adequate " sampTe ⁇ has ⁇ been collectecl7 the needle is removed leaving a minor wound, which heals in a few minutes.
  • the procedure is relatively quick with few side effects, although minor bruising can sometimes occur.
  • sample tubes are commonly provided with no additives (for blood clot analysis), serum separator gels or anticoagulants (e.g. heparin, EDTA, sodium citrate for most analyses), chelating agents (e.g. sodium EDTA for the removal of metal ions), complement inactivators (e.g. acid-citrate dextrose, for HLA tissue typing) or certain preservatives (e.g. sodium fluoride and potassium oxalate, antiglycolytic agents that preserve glucose levels).
  • serum separator gels or anticoagulants e.g. heparin, EDTA, sodium citrate for most analyses
  • chelating agents e.g. sodium EDTA for the removal of metal ions
  • complement inactivators e.g. acid-citrate dextrose, for HLA tissue typing
  • certain preservatives e.g. sodium fluoride and potassium oxalate, antiglycolytic agents that preserve glucose levels.
  • blood sample tubes are colour coded and this coding
  • the sample may be divided between different collection tubes each with different additives, as described above.
  • An advantage of the syringe device is that the user can control the differential pressure gradient, thereby controlling the rate of blood flow and also the volume of sample taken. This is particularly advantageous with patients with small or fragile veins, where an excess of pressure may result in the collapse of the vein e.g. elderly patients, oncology patients, severely burned patients, obese patients, or patients with unreliable or fragile veins.
  • a disadvantage of the syringe technique is the requirement to transfer the blood to sample tubes, thereby increasing the risk of spillage, cross- contamination, user contamination and analytical outcome.
  • vacuum tubes for example the Vacutainer® blood collection tubes.
  • These devices comprise a sterile glass or plastic tube with a rubber cap, and an enclosure that is evacuated to create a vacuum inside the tube. Often they are used in conjunction with double-ended needles. The first needle is inserted into the vein as described above, whilst the second, shorter, needle is pushed into the rubber cap of the vacuum tube therefore coming into contact with the partial vacuum contained therein. Due to the differential pressure gradient between the vein and the vacuum tube, blood quickly flows from the vein through the hypodermic needle into the tube. As blood enters the tube, the pressure increases until the pressure inside the tube is equivalent to the vein, whereupon blood flow ceases.
  • the double-ended needle may be in the form of a standard butterfly needle, or alternatively, the second needle may be encased in a plastic sheath to prevent the user from suffering a needle-prick injury.
  • the filled tube is then removed, and since it is already sealed there is no need to transfer the sample and so the problems associated with transfer are avoided.
  • a second tube can be used and filled in the same way, thereby permitting multiple samples of blood to be taken using different vacuum tubes.
  • the vacuum tubes are provided with different additives to stabilise samples prior to testing (as described above) and these, too, are indicated by colour-coded caps. It is important to remove the tube before withdrawing the needle, as there may still be some suction left, causing pain upon withdrawal.
  • a disadvantage of the vacuum tube is that the user cannot see fluid flow through the needle nor can one control the differential pressure gradient across the vein. This is determined by the vacuum pressure upon manufacture, and therefore the user cannot control the blood flow rate across the needle. As patients have different blood pressures (dependent on age, size, disease state etc.) the blood flow is different from one patient to the next. Although some tubes are manufactured for different flow and draw volumes, it can be difficult for the user to determine the appropriate tube (and therefore vacuum pressure) to use. Failure to choose the correct pressure can result in an insufficient blood sample volume (insufficient vacuum pressure) or, alternatively, collapse of the vein (excessive vacuum pressure). This has implications for the use of vacuum tube additives (e.g.
  • a modified syringe for extracting a body fluid sample that, following extraction, can be adapted to provide a container that is suitable for storing or transporting said sample prior to further analysis. Consequently, this modified syringe overcomes the need to transfer body fluid samples into various assay tubes at the point of extraction, thereby simplifying the extraction procedure.
  • a syringe for extracting a body fluid sample comprising: at least one elongate barrel member having, at a first end, a removable end-cap including a nozzle; and, at a second end, at least one plunger assembly comprising a transverse piston and, operably but removably connected thereto, a longitudinal shaft member; and a shield for placing partially over said end-cap after use of said syringe;
  • said nozzle is fashioned for the j-emavable-attachment-of-a-needle—
  • said needle is removably attached by means of a friction fit and/or a screw fix or any other suitable means known to those skilled in the art.
  • a screw fix the needle has an internal thread and said nozzle has a complimentary external thread, or vice versa.
  • said needle is fixed by a friction fit augmented by lock means such as a luer lock.
  • said needle is contiguous with said syringe and so fixed thereto.
  • said nozzle is fashioned for the removable attachment of syringe tubing.
  • said syringe tubing may be linked to a needle, such as but not limited to, a push-button valve butterfly needle, intravenous cannula, or the like, which needle is inserted into the body (e.g. a vein) and permits flow of the fluid once the valve is opened.
  • a needle such as but not limited to, a push-button valve butterfly needle, intravenous cannula, or the like, which needle is inserted into the body (e.g. a vein) and permits flow of the fluid once the valve is opened.
  • said body fluid sample is extracted through said tubing into said barrel, and contained in accordance with the invention as described.
  • the user can use a second syringe according to the invention to extract a second fluid sample.
  • said end-cap is attached to, and released from, said barrel using a screw thread arrangement.
  • said end-cap has an internal thread and said barrel member a complimentary external thread, or vice versa.
  • said piston is fashioned such that it provides a hermetic seal in said barrel, therefore preventing loss of fluid from the second end of said barrel.
  • said end-cap once attached provides a similar, hermetic seal preventing loss of extraeted-fluid-from-the-first ⁇ end-of * said ⁇ barrel Furth3 ⁇ 4 7 ⁇ i3 ⁇ 4 ⁇ nozzle ⁇ is ⁇ fashioned such that fluid flow can only occur through said nozzle upon movement of said plunger assembly.
  • said shaft member is attached to, and released from, said piston using a screw thread arrangement.
  • said piston has an internal thread and said shaft a complimentary external thread, or vice versa.
  • said shaft member further comprises a grip member at the opposite end to said piston, thereby facilitating movement of said plunger assembly by the user.
  • said grip member may be of numerous shapes and cross-sections.
  • said shield is ideally located over said end-cap by means of a friction fit.
  • locating said shield over said end-cap provides a further seal containing the extracted body fluid sample in said barrel member.
  • this also prevents the likelihood of needle-prick injuries when using a needle and syringe.
  • a different mechanism of operation is used for each.
  • said end-cap is attached to, and removed from, said barrel member using a screw fix arrangement whereas said shield employs a friction fit arrangement, or, less preferably, vice versa.
  • said shaft is attached to, and removed from, said piston using the same attachment mechanism as the end-cap.
  • a needle-cap is provided for location, ideally, using a friction fit, over said needle.
  • this therefore provides an additional level of safety for the user thus further reducing the likelihood of a needle-prick injury.
  • said needle-cap is located over said needle, and said shield placed over said end-cap.
  • said barrel and/or said end-cap is/are transparent and, ideally, tapered toward said nozzle, thereby improving visibility during use. Further, this helps to improve user control of fluid extraction.
  • said barrel has a volume capacity of 1-20 ml, or more ideally between 3-10 ml and more ideally still selected from one of the following options 3, 5, 10, ml.
  • the volume of said barrel will vary according to the size of the fluid sample to be extracted.
  • said needle has a diameter and length appropriate for the extraction of the body fluid sample.
  • the size of said needle will depend upon the site from which the body fluid is to be extracted and also the volume to be extracted such as, but not limited to, 7-33 gauge according to the Stubs Iron Wire Gauge System.
  • said barrel further contains at least one chemical additive, such as but not limited to, heparin, EDTA, sodium citrate, Citrate theophylline adenosine dipyridamole (CTAD), chelating agents, complement inactivators, Sodium polyanethol sulphonate, serum separator gels, or chemical preservatives.
  • at least one chemical additive such as but not limited to, heparin, EDTA, sodium citrate, Citrate theophylline adenosine dipyridamole (CTAD), chelating agents, complement inactivators, Sodium polyanethol sulphonate, serum separator gels, or chemical preservatives.
  • said barrel comprises a visual indicator of the nature of an additive contained therein such as, but not limited to, a coloured or partially coloured barrel member and/or a coloured or partially coloured piston.
  • said barrel further comprises markings and/or indentations to indicate the volume of body fluid extracted.
  • said barrel further comprises a label to permit the user to provide information to identify the body fluid sample, such as but not limited to, patient source, fluid type, or date.
  • said barrel is fabricated from any appropriate medical grade material, such as but not limited to, plastic or glass, such that it is sufficiently durable and can be sterilised for clinical or medical use.
  • said needle is fabricated from any appropriate medical grade material, such as but not limited to, fine gauge stainless steel, titanium, ceramic material, diamond or diamond-coated substrate or the like, such that it is sufficiently durable and possesses the capacity to provide a sharpened tip for piercing patient tissue.
  • the design of the syringe enables the user to perform body fluid sample extraction.
  • a needle either contiguous with, or attached to, the nozzle of the syringe or attached via tubing, is inserted into the body e.g. a vein.
  • the user then retracts the plunger assembly from the barrel creating a differential pressure gradient, consequently filling the syringe with body fluid.
  • the user places a shield over the end-cap, thereby sealing the nozzle.
  • the user may also place a needle-cap over said needle, thereby reducing the risk of needle-prick injury.
  • the user removes the shaft member of the plunger assembly from the piston, thereby containing the extracted sample in the syringe for transport to the laboratory.
  • a technician is then able to unscrew the end-cap from the syringe thus gaining access to the sample for analysis.
  • a syringe for extracting at least one body fluid sample comprising:
  • an elongate barrel member longitudinally partitioned into a plurality of compartments, and having, at a first end, a guide plate for guiding said sample into at least one of said compartments and a removable end-cap including a nozzle; and, at a second end, at least one plunger assembly for each compartment wherein said assembly comprises a transverse piston and, operably but removably connected thereto, a longitudinal shaft member; and a shield for placing partially over said end-cap after use of said syringe;
  • each shaft member is located in a removable harness whereby their movement can be co-ordinated.
  • guide plate is located in said end-cap, ideally sealed therein, and it preferably comprises a plurality of holes or channels which, in use, are aligned with said compartments.
  • said compartments further contain at least one chemical additive, such as but not limited to, heparin, EDTA, sodium citrate, Citrate theophylline adenosine dipyridamole (CTAD), chelating agents, complement inactivators, Sodium polyanethol sulphonate, serum separator gels, or chemical preservatives. More ideally, said compartments contain different additives. As will be appreciated by those skilled in the art, according to this second aspect of the invention, the user can obtain multiple samples of body fluid in separate compartments. Advantageously, as each compartment may contain a different additive, the samples are prepared for different analytical tests.
  • CAD Citrate theophylline adenosine dipyridamole
  • a syringe for extracting at least one body fluid sample comprising: an elongate barrel member, longitudinally partitioned into a plurality of inner barrels, and having, at a first end, a guide plate for guiding said sample into at least one of said inner barrels and a removable end-cap including a nozzle; and, at a second end, at least one plunger assembly for each inner barrel wherein said assembly comprises a transverse piston and, operably but removably connected thereto, a longitudinal shaft member; and a shield for placing partially over said end-cap after use of said syringe- whereby, in use, movement of said plunger assemblies out of said inner barrels draws said sample into at least one of said inner barrels through said nozzle and said guide plate,
  • said shaft members are located in a removable harness whereby their movement can be co-ordinated.
  • said guide plate is located in said end-cap, ideally sealed therein, and it preferably comprises a plurality of holes or channels which, in use, are aligned with said inner barrels.
  • said inner barrels further contain at least one chemical additive, such as but not limited to, heparin, EDTA, sodium citrate, Citrate theophylline adenosine dipyridamole (CTAD), chelating agents, complement inactivators, Sodium polyanethol sulphonate, serum separator gels, or chemical preservatives.
  • said inner barrels contain different additives.
  • the user can obtain multiple samples of body fluid in separate inner barrels.
  • the samples are prepared for different analytical tests.
  • the device is used for, research, cosmetic or medical purposes.
  • any of the aforementioned aspects of the invention may, in preferred embodiments, include or be characterised by any of the aforementioned features pertaining to the syringe.
  • preferred features of each aspect of the invention may be as described in connection with any of the other aspects.
  • any feature disclosed herein may be replaced by an alternative feature serving the same or a similar purpose.
  • Figure 1 A sectional side assembled view of a syringe, according to a first aspect of the invention
  • FIG. 1 A sectional side exploded view of the different components of the syringe shown in Figure: 1 ;
  • FIG. 3 A sectional side assembled, view of the syringe shown in Figure A after use, wherein the syringe is full of body fluid extract and the shaft of the plunger assembly has been removed;
  • Figure 4 A sectional side view of a syringe in figure' 1 prior to use;
  • FIG. 5 A sectional side assembled view of a syringe according to a second or third aspect of the invention.
  • Figure 6 A sectional side exploded view of the syringe in figure 5;
  • FIG 7. A guide plate for use in a syringe according to a second or third aspect of the invention, as viewed from X in figure 6;
  • Figure 8. A transverse cross-sectional view of a syringe according to a third aspect of the invention, as viewed from Y in figure 6; and
  • Figure 9. A sectional side view of a syringe in figure 6 after use.
  • the syringe is generally elongate and is of a size that is suitable for the volume of body fluid to be extracted.
  • the syringe is generally made from synthetic materials including plastics, or alternatively glass. Ideally, the material of manufacture is also transparent, to improve visibility during use.
  • the syringe has a longitudinal elongate barrel member [12] which may have a variety of cross-sectional shapes, but ideally is circular in cross- section (not shown).
  • a removable end-cap [1 1 ] which is hermetically attached to the barrel by means .of a screw thread arrangement [1 ].
  • the end-cap in this illustration, comprises a nozzle [1 1 a] fashioned for the removable attachment of a needle [6], which is securely fixed thereto prior to use.
  • the needle [6] is contiguous with the nozzle (not shown).
  • said nozzle may be fashioned for the removable attachment of syringe tubing that is connected at the opposite end to a needle, such that fluid is extracted via such tubing (not shown).
  • the barrel [12] and/or end-cap [11] may be tapered toward the nozzle to improve visibility during use (not shown).
  • a plunger assembly comprising a transverse piston [2] and operably connected thereto a removable longitudinal shaft member [3].
  • the shaft member is securely fixed to the piston prior to use by means of a screw thread arrangement [1] such that it cannot be moved during use.
  • the shaft member comprises a grip member [3a] to facilitate use.
  • the individual components of the syringe are best viewed in figure 2 , where there is shown a sectional side exploded view of the different components of the syringe shown in Figure 1 ..
  • the barrel [12] further contains an appropriate chemical additive (not shown) to preserve the body fluid sample. The nature of the additive may be indicated by the colour of the piston [2] and/or barrel (not shown).
  • the plunger assembly is moved out of the barrel [12], thereby drawing in body fluid.
  • the syringe is provided with a shield [4], which is located over the end-cap [1 1], ideally by means of a friction fit (not shown).
  • the shield is located over only the furthermost end of the end-cap thus ensuring a user can grip at least a part of the end cap in order to remove same from the barrel member.
  • the user may also locate a needle-cap [5] over the needle [6] for improved safety.
  • the shaft member [3] is removed from the piston [2].
  • the barrel may also further comprise a label [7] which can be used by the user to identify the sample.
  • the screw- thread arrangements [1 ] can be clearly seen on the piston [2] and the end-cap [1 1].
  • the shaft member [3] is provided with an external screw thread and the piston [2] a complimentary internal screw thread.
  • the end-cap [11] is provided with an internal screw thread and the first end of the barrel member [12] a complimentary external screw thread.
  • FIG 3 there is shown a sectional side assembled view of the syringe shown in figure 1 after use, wherein the barrel [12] is full of body fluid extract [8], As shown, the shaft [3] of the plunger assembly has been removed, and the shield [4] and needie-cap [5] located over the end- cap [1 1 ] and needle [6], respectively.
  • the syringe provides a sealed container wherein the extracted body fluid sample is hermetically contained in the barrel for storage and transport, until subsequent removal of the shield [4] and end-cap [1 1 ].
  • the barrel contains an air-space [9] located adjacent to the end-cap [1 1]. This reduces the risk of spillage when the laboratory technician opens the tube to access the blood.
  • FIG4 there is shown a sectional side view of a syringe in figure 1 prior to use.
  • the end-cap [11 ] is securely attached to the first end of the barrel.
  • the needle [6] is exposed for insertion into the body and the plunger assembly fully engaged in the barrel [12],
  • the air-space [9] is present prior to use, due to the tapered nature of the barrel and end- cap (not shown). Therefore, the barrel contains a sealed, and also ideally sterile, chamber for containment of the body fluid sample.
  • the barrel may provided with the at least one appropriate chemical additive for preservation of the body fluid sample, which may be illustrated by a colour coded piston or barrel (not shown).
  • the barrel [12] of the syringe comprises at least one longitudinal bisecting wall partitioning the barrel into a plurality of compartments.
  • the barrel [12] is longitudinally partitioned into a plurality of inner barrels [13], this is best viewed from the transverse cross-sectional view shown in figure 8 .
  • the plurality of compartments or inner barrels permits multiple samples of body fluid to be extracted simultaneously, each sample being contained in its respective separate compartment or inner barrel.
  • the compartments or inner barrels further contain at least one additive, and more ideally contain a different additive with respect to each other (not shown). In this way, multiple samples can be extracted and preserved accordingly for further disparate analytical tests.
  • the barrel comprises a removable end-cap [1 1] as described above.
  • each compartment (or inner barrel) comprises its own plunger assembly as described above, comprising a longitudinal shaft [3] operably, but removably, attached to a transverse piston [2] by means of screw thread arrangement [1].
  • the plunger assemblies may further comprise a removable harness [10] that engages the plunger assembly of each compartment (or inner barrel) to coordinate their movement such that the plungers can be moved simultaneously.
  • the second and third aspects of the invention also further comprise a guide plate [15] positioned at the first end of the barrel [12].
  • the guide plate is sealingly engaged with the barrel and is provided with a plurality of guide holes or channels [14], which serve to direct the flow of the extracted body fluid into the respective compartments or inner barrels.
  • the structure of the guide plate is best viewed in figure 7 .
  • each respective compartment or inner barrel [13] comprises a plunger assembly, comprising a piston and removably attached thereto a shaft [3].
  • the harness [10] can be used to co-ordinate the simultaneous movement of the plunger assemblies, which following use is subsequently removed.
  • Each respective shaft member can then be unscrewed from their piston.
  • the guide plate [15] is located in the end-cap [11], and is separated from the nozzle by an air space [9].
  • the cross-section of the guide plate, as viewed from X in figure 6 is shown in figure 7 .
  • FIG 8 there is shown a transverse cross-sectional view of a syringe according to a third aspect of the invention, as viewed from Y in figure 6.
  • the barrel [12] contains a pair of inner barrels [13].
  • the syringe may comprise greater than two inner barrels (not shown).
  • Figure 9 shows a sectional side view of a multiple sample syringe after use.
  • the compartments, or inner barrels, are full of body fluid extract [8].
  • An air space [16] is provided between same and the end of the barrel.
  • the fluid [8] together with a little air is then drawn, via the holes [14] of the guide plate [15], into the inner barrels or compartments. Further air [16] may be drawn to reduce the risk of spillage when the end-cap [1 1 ] is unscrewed.
  • the shafts [3] of the plunger assemblies have been removed, and the shield [4] and needle-cap [5] located over the end-cap [1 1] and needle [6], respectively.
  • the syringe provides a sealed container of multiple extracted body fluid samples for storage and transport, until subsequent removal of the shield [4] and end-cap [1 1].
  • Use of the syringe as afore described thus ensures that at least one sample of body fluid can be extracted and contained and transported: i) relatively easily with a user determining flow rate and volume, with the possibility of extracting multiple samples in one procedure, and ii) with no requirement for subsequent transfer, thereby reducing the risk of cross- contamination or the possibility of a user contacting potentially dangerous material.

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Abstract

La présente invention concerne une seringue modifiée, conçue pour procurer un récipient fermé hermétiquement (12) permettant le stockage et le transport sécurisés d'un échantillon de fluide extrait ainsi. Ladite seringue comprend un embout protégé et amovible (11) et au moins un ensemble poussoir comportant au moins un élément de tige amovible (3). Après utilisation, ladite protection étant en place, le retrait dudit ou desdits éléments de tige procure un récipient pour le stockage ou le transport dudit échantillon, jusqu'à ce que ledit embout (11) soit retiré.
PCT/SG2013/000257 2012-06-21 2013-06-20 Seringue modifiée WO2013191659A1 (fr)

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SG201204639-7 2012-06-21
SG201204639 2012-06-21

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105078475A (zh) * 2015-06-30 2015-11-25 李秋环 一次性回旋式防针刺安全静脉采血针
WO2019097015A1 (fr) * 2017-11-17 2019-05-23 Vetter Pharma-Fertigung GmbH & Co. KG Contenant à médicaments

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4057050A (en) * 1974-11-29 1977-11-08 Sarstedt W Devices for extracting blood
GB1592935A (en) * 1977-03-16 1981-07-15 Ballies U Device for use in the centrifugal separation of components of a liquid
EP0420126A1 (fr) * 1989-09-26 1991-04-03 Walter Sarstedt Geräte und Verbrauchsmaterial für Medizin und Wissenschaft Dispositif de prélèvement sanguin
DE3941105A1 (de) * 1989-12-13 1991-06-20 Holger Dr Mueller Vorrichtung zur abnahme von blut
EP0643944A1 (fr) * 1993-09-22 1995-03-22 B. Braun Melsungen Ag Dispositif de prélèvement de sang
WO1997026825A1 (fr) * 1996-01-23 1997-07-31 Abbott Laboratories Dispositif de prelevement du sang
US20110178427A1 (en) * 2008-03-07 2011-07-21 Becton, Dickinson And Company Flashback Blood Collection Needle
WO2011114413A1 (fr) * 2010-03-15 2011-09-22 Matumura Takahito Tube de prélèvement sanguin sous vide, unité de prélèvement sanguin et dispositif pour discriminer des méthodes d'essai

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4057050A (en) * 1974-11-29 1977-11-08 Sarstedt W Devices for extracting blood
GB1592935A (en) * 1977-03-16 1981-07-15 Ballies U Device for use in the centrifugal separation of components of a liquid
EP0420126A1 (fr) * 1989-09-26 1991-04-03 Walter Sarstedt Geräte und Verbrauchsmaterial für Medizin und Wissenschaft Dispositif de prélèvement sanguin
DE3941105A1 (de) * 1989-12-13 1991-06-20 Holger Dr Mueller Vorrichtung zur abnahme von blut
EP0643944A1 (fr) * 1993-09-22 1995-03-22 B. Braun Melsungen Ag Dispositif de prélèvement de sang
WO1997026825A1 (fr) * 1996-01-23 1997-07-31 Abbott Laboratories Dispositif de prelevement du sang
US20110178427A1 (en) * 2008-03-07 2011-07-21 Becton, Dickinson And Company Flashback Blood Collection Needle
WO2011114413A1 (fr) * 2010-03-15 2011-09-22 Matumura Takahito Tube de prélèvement sanguin sous vide, unité de prélèvement sanguin et dispositif pour discriminer des méthodes d'essai

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105078475A (zh) * 2015-06-30 2015-11-25 李秋环 一次性回旋式防针刺安全静脉采血针
WO2019097015A1 (fr) * 2017-11-17 2019-05-23 Vetter Pharma-Fertigung GmbH & Co. KG Contenant à médicaments

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