WO2020012252A1 - Appareil de collecte d'échantillons et procédé d'assemblage automatisé de celui-ci - Google Patents

Appareil de collecte d'échantillons et procédé d'assemblage automatisé de celui-ci Download PDF

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Publication number
WO2020012252A1
WO2020012252A1 PCT/IB2019/051287 IB2019051287W WO2020012252A1 WO 2020012252 A1 WO2020012252 A1 WO 2020012252A1 IB 2019051287 W IB2019051287 W IB 2019051287W WO 2020012252 A1 WO2020012252 A1 WO 2020012252A1
Authority
WO
WIPO (PCT)
Prior art keywords
sample collection
cap
collection tube
tube
screwing
Prior art date
Application number
PCT/IB2019/051287
Other languages
English (en)
Inventor
Parth Rajeshkumar AGRAWAL
Original Assignee
Agrawal Parth Rajeshkumar
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 Agrawal Parth Rajeshkumar filed Critical Agrawal Parth Rajeshkumar
Publication of WO2020012252A1 publication Critical patent/WO2020012252A1/fr

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Classifications

    • 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
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154—Devices using pre-evacuated means
    • 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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150351—Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0689—Sealing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/143—Quality control, feedback systems
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/16—Reagents, handling or storing thereof

Definitions

  • the disclosure generally relates to sample collection apparatus, and more particularly to an automated method for assembling components of the sample collection apparatus.
  • the vacuum blood collection tubes consist of a double-pointed needle, a plastic holder or an adaptor and enclosed in sterile container with inbuilt negative pressure to draw samples such as blood in predetermined quantity as per the tests.
  • enclosed containers or vacuum tubes in the vacuum blood collection system facilitate the blood to flow directly from patients’ vein into the appropriate test tube.
  • the vacuum blood collection tubes are manufactured using non-friable plastic material and are easy for transportation of the sample.
  • a series of vacuum tubes with rubber stoppers of different colors indicative of the type of additives or reagents contained in the tube are manufactured.
  • sample collection tubes are now extensively used in hospitals and health care units, hygiene and quality of the tubes are very critical aspects to be addressed during the manufacturing process, so as to eliminate any risk of spread of contagious infections. As such, it is desirable to have a completely automated system and method for manufacturing sample collection tubes so as to minimize any human touch intervention thereby improving the hygiene and quality of the tubes.
  • One prior art discloses a system and method for placing a screw cap with internal threads along with a bottle shaped container through a conveyor to a pressing station wherein due to compression force the screw s cap is pressed over the bottle neck and by virtue of elastic deformation, the screw cap is held intact with the bottle.
  • the prior art does not teach achieving a completely screwed position of the screw cap.
  • Another prior art teaches a method of arranging tubes and the screw cap arranged in a perpendicular axis over a rotatory platform such that several tubes are simultaneously plugged with screw 7 caps by virtue of both the force acting in longitudinal direction as well as the rotatory 7 force at the mouth of the tube.
  • the prior art method has a shortcoming in that the fixing of cap is carried out after creating the negative pressure in the tube and as such complete vacuum may not get created in the tube.
  • a sample collection apparatus comprises a tube comprising an array of slots on the outer surface of its open end, configured for receiving a screwing cap comprising one or more protrusions on its inner step wherein the screwing cap encloses the circumference of the open end of the tube such that an opening is formed for receiving a rubber cap.
  • the rubber cap is configured for sealing the tube such that the risk of contamination is reduced substantially.
  • the apparatus comprises a locking ring fitted in the annular space between the upper portion of the screwing cap and circumference of the rubber cap. The screwing cap is further screwed around the longitudinal axis of the tube so as to prevent accidental opening of the rubber cap.
  • Figure 1 is an exploded view of the sample collection apparatus, in accordance with various embodiments of the present disclosure
  • Figure 2A and 2B illustrate sectional view of the sample collection apparatus and the screw cap assembly in accordance with embodiments of the present disclosure
  • Figure 3 illustrates a method for assembling the sample collection apparatus of the present disclosure on an assembly line in accordance with embodiments of the present disclosure
  • the sample is, for example, blood sample commonly collected at hospitals and health care facilities for diagnostic potposes and such. Since the environments where such sample collections take place are prone to contamination by contagious micro-organisms, it is an object of the present disclosure to provide an apparatus that substantially reduces the risk associated with usage and transportation of sample collection apparatuses.
  • the sample collection apparatus 100 comprises a sample collection tube 110, a screwing cap 120, a rubber cap 130 and a locking ring 140.
  • a double edged needle or a syringe is used in combination with the sample collection apparatus 100 to receive and store the samples.
  • the sample collection tube 110 is, for example, made of medical grade polymer.
  • the hollow portion of the sample collection tube 110 is pre-processed before usage.
  • the pre-processing includes but is not limited to the steps of coating or spraying reagents, blood clotting agents and drying the tube 110
  • the top portion (open end) of the sample collection tube 110 comprises a plurality' of slots on the outer surface. These slots engage with the one or more serrations provided on the inner step of the screwing cap 120 (described later) to provid e a secondary locking of the sample collection apparatus 100 so as to prevent accidental unlocking of the apparatus 100 during logistical operations.
  • a negative pressure is created in the tube 110 so as to draw the blood directly from the subjects’ vein thereby reducing the risks associated with handling sample collection procedures.
  • the sample is collected from the subject using a syringe and injected into the sample collection tube 110
  • the screwing cap 120 is a cylindrical hollow cap comprising one or more serrations on its low'er inner step such that the lower portion of the screwing cap 120 encloses the outer surface of the sample collecting tube 110.
  • the outer surface of the screwing cap 120 comprises plurality of threads to assist gripping of the screwing cap 120 during various operations such as opening or screwing of the sample collection tube 110.
  • a torque tightening fixture grips the outer surface of the screwing cap 120 for screwing the cap 120 around the circumference of the sample collection tube 110.
  • the other end of the screwing cap 120 receives the rubber cap 130.
  • the rubber cap 130 is made of medical grade rubber and comprises a groove on one side.
  • the cross-section of the rubber cap is smaller than the circumference of the screwing cap 120 by a pre-determined fraction such that the rubber cap 130 fits into the upper region of the screwing cap 120 so as to cover the mouth of the sample collection tube 110.
  • the groove formed on the opposite side of the rubber cap 130 portion covering the mouth of the sample collection tube 110 also provides the necessary support during the manufacturing process described in the later sections of this description.
  • the apparatus 100 comprises a locking ring 140, preferably made of plastic.
  • the locking ring 140 is placed in the annular space formed between the upper region of the screwing cap 120 and the edges of the grooved region of the rubber cap 130.
  • the locking ring 140 ensures that the rubber cap 130 is locked in a fixed position thereby preventing accidental release of the rubber cap 130 and limiting the exposure to contamination.
  • FIG, 2A a sectional view of the sample collection apparatus 200 in closed condition is illustrated in 2A.
  • the open end of the sample collection tube 210 is covered by the rubber cap and locking ring (not shown) and further a screwing cap 220 is tightly screwed to lock the position of the sample collection tube.
  • a sectional view of the screwing cap 220 in tightened or locked position with the sample collection tube 210 is disclosed.
  • an array of slots on the outer surface of the sample collection tube 210 are interlocked with the serrations provided on the inner step of the screwing cap 220 to provide a secondary locking to the tube such that the sample collection apparatus 100 is prevented from accidental unlocking during transportation and such.
  • 2C illustrates a sectional view of the rubber cap 230 that covers the open end of the sample collection tube 210.
  • the top portion of the rubber cap 230 is a hollow with tapering edges that are configured for receiving a locking ring. Further, the screwing cap 220 and the locking ring keep the rubber cap 230 intact during storage and transportation of the sample collection apparatus 100.
  • a method for assembling the sample collection apparatus 100 is disclosed.
  • the method of assembling is carried out in a manufacturing set up in an automated manner.
  • An assembly line as such is known in the art as commonly used set of machines and/or workers arranged in a manner so as to progressively assemble the final product, however, as one skilled in the art may appreciate, every product and variation of every product requires careful designing of the assembly line as significant manufacturing costs are owed to the assembly line.
  • Several attributes of the manufacturing process are taken into consideration before an assembly line is set up at the manufacturing facility, such as, the sequence of operations involved, the inflow of raw materials or components, packaging units, product demand etc.
  • a lean assembly line is always desirable for a manufacturing process for various reasons including but not limited to complete automation, reduction in manufacturing cost and eventually the cost of the product, reducing wastage and excessive labor charges etc.
  • the assembly line may comprise a plurality of machines or devices arranged in a pre-determined sequence and configured for performing one or more functions in the manufacturing process.
  • the machines or devices may be known in the art otherwise, only the function achieved by such machines or device in a sequence is described herein to the fullest extent.
  • empty sample collection tubes 110 arranged on a conveyor are gripped by friction grippers such as abrasive rollers.
  • the lower portion of the sample collection tube is gripped by the friction grippers such that the tubes 110 are held in upright position firmly during the subsequent processing steps.
  • the gripping may be achieved by the conveyor itself.
  • Various means, such as position sensors, may be included on the assembly line to detect and rectify faulty position of the tubes on the conveyor.
  • the pre-processing of the sample collection tubes 110 is carried out using a plurality of equipment arranged substantially perpendicular to the mouth of the sample collection tubes 110.
  • various steps are earned out such as adding reagents (for example, by a dropper), spraying anti-clot agent (for example, by a nozzle spray), drying the tube (for example, by a dryer) arranged in the pre-determined sequence.
  • adding reagents for example, by a dropper
  • spraying anti-clot agent for example, by a nozzle spray
  • drying the tube for example, by a dryer
  • the equipment for each of the reagents A, B, C and D is arranged in the sequence A-B-C-D-spraying-drying such that four sample collection tubes 110 at a time pass the pre-processing step in the pre determined sequence.
  • a screwing cap 120 is placed on each of the one or more sample collection tubes 110 after pre-processing, using, for example, a mechanical or robotic arm.
  • Suitable sensing means may be installed in conjunction with the mechanical arm to detect the position of the sample collection tubes 110 as well as to detect the completion of pre- processing steps, for example, by detecting presence of reagent in the tube.
  • screwing cap 120 of different colors may be fed to the mechanical or robotic arm corresponding to the different reagents added to the sample collection tubes 110.
  • the screwing cap 120 is placed or affixed on the open end of the sample collection tube 110 such that the lower end of the screwing cap 120 having serrations on its inner surface is in contact with the one or more slots provided on the outer surface of the sample collection tube 110 at its open end.
  • the screwing cap 120 is only partially screwed around the circumference of the sample collection tube 110 to enable further processing of the sample collection apparatus 100.
  • the open end of the sample collection tube 110 is accessible through the hollow interior opening of the screwing cap 120 for further processing.
  • the sample collection tubes are passed through a processing chamber for a pre-determined time period.
  • the processing chamber comprises a holding fixture for holding the sample collection tubes 110, one or more processing units and a plurality of vents on the upper region of the processing chamber.
  • Each of the plurality of vents are arranged to have one rubber cap 130 such that the cross section of each vent is substantially equal to the cross section of the rubber cap 130.
  • one or more processing units perform the steps of creating a negative pressure inside the sample collection tube by removing any air present in the tube.
  • the processing units perform the steps necessary for retaining the reagent inside the tube but may not create negative pressure.
  • the processing unit comprises a plurality of probes configured for sending a brief electric shock through the tubes such that any contaminating micro-organisms are eliminated whereas the tube is maintained intact with positive pressure. In such a case, the cost associated with building negative pressure inside the tube 110 is avoided and the sample collection apparatus 100 when in use, receives the sample through a syringe commonly used by the healthcare professionals.
  • each of the plurality of rubber caps 130 arranged in the vents of the processing chamber are placed on the open end of the sample collection tubes 110.
  • the rubber caps 130 engage at the mouth of the sample collection tube 110 under negative atmospheric pressure
  • the rubber caps 130 are arranged on the mouth of the sample collection tube 110 under positive atmospheric pressure either manually or using a robotic arm. The pressure causes the rubber caps 130 to pass through the vents in a manner that the each of the one or more rubber caps 130 fall into each of the one or more sample collection tubes 110 arranged substantially perpendicular to the vents.
  • steps 320 and 325 are carried out in a batch wise manner such that a pre-determined number of sample collection tubes 110 enter the processing chamber at a time and the assembled sample collection tubes move to the next processing step (described later).
  • steps 320 and 325 are carried out in a continuous manner such that the sample collection tubes 110 arranged on a conveyor pass through the processing chamber continuously one at a time.
  • a torque tightening fixture arranged in a horizontal axis immediately after the processing chamber grips the screwing cap 120 with the help of threads or ridges formed on the outer surface of the screwing cap 120.
  • the torque tightening fixture is configured to move in a clockwise or anti-clockwise manner after gripping the screwing cap 120 such that the screwing cap 120 is tightened around the mouth of the sample collection tube 110.
  • the torque tightening fixture is programmed to move only within a pre-determined range so as not to damage the screwing cap 120 or the sample collection tubes 110 and to ensure that only enough tightening is achieved to open the sample collection apparatus 100 by a user without much effort.
  • the sample collection apparatus 100 is ready for packaging and shipping.
  • the method of assembling the sample collection apparatus 100 provide several advantages including but not limited to reduced cost of manufacturing, low wastage of assembling components, increased production cycle and overall lower cost to the user of the sample collection apparatus 100.
  • a centralized computer system may be implemented at the manufacturing site to completely monitor and control the method steps 300-330.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pathology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)

Abstract

L'invention concerne un appareil de collecte d'échantillons. L'appareil de collecte d'échantillons comprend un tube comprenant un réseau de fentes sur la surface extérieure de son extrémité ouverte, configuré pour recevoir un capuchon à vissage comprenant une ou plusieurs saillies sur sa marche interne, le capuchon à vissage enfermant la circonférence de l'extrémité ouverte du tube de telle sorte qu'une ouverture est formée pour recevoir un capuchon en caoutchouc configuré pour sceller de manière libérable le tube de telle sorte que le risque de contamination est sensiblement réduit. En outre, l'appareil comprend une bague de verrouillage ajustée dans l'espace annulaire entre la partie supérieure du capuchon à vissage et la circonférence du capuchon en caoutchouc pour empêcher une ouverture accidentelle du capuchon en caoutchouc. En outre, l'invention concerne un nouveau procédé d'assemblage de l'appareil de collecte d'échantillons, ainsi que des améliorations et des avantages associés.
PCT/IB2019/051287 2018-07-11 2019-02-18 Appareil de collecte d'échantillons et procédé d'assemblage automatisé de celui-ci WO2020012252A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201821025924 2018-07-11
IN201821025924 2018-07-11

Publications (1)

Publication Number Publication Date
WO2020012252A1 true WO2020012252A1 (fr) 2020-01-16

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ID=69141962

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Application Number Title Priority Date Filing Date
PCT/IB2019/051287 WO2020012252A1 (fr) 2018-07-11 2019-02-18 Appareil de collecte d'échantillons et procédé d'assemblage automatisé de celui-ci

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WO (1) WO2020012252A1 (fr)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0517119B1 (fr) * 1991-06-06 1995-11-22 Becton, Dickinson and Company Tube pour collecter une petite quantité de sang
EP1711412B1 (fr) * 2004-01-23 2010-11-17 Greiner Bio-One GmbH Procede pour assembler un capuchon et un recipient

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0517119B1 (fr) * 1991-06-06 1995-11-22 Becton, Dickinson and Company Tube pour collecter une petite quantité de sang
EP1711412B1 (fr) * 2004-01-23 2010-11-17 Greiner Bio-One GmbH Procede pour assembler un capuchon et un recipient

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