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WO2017049363A1 - Distribution volumétrique de sang - Google Patents

Distribution volumétrique de sang Download PDF

Info

Publication number
WO2017049363A1
WO2017049363A1 PCT/AU2016/050898 AU2016050898W WO2017049363A1 WO 2017049363 A1 WO2017049363 A1 WO 2017049363A1 AU 2016050898 W AU2016050898 W AU 2016050898W WO 2017049363 A1 WO2017049363 A1 WO 2017049363A1
Authority
WO
WIPO (PCT)
Prior art keywords
blood
tube
volume
dispenser
pump
Prior art date
Application number
PCT/AU2016/050898
Other languages
English (en)
Inventor
Damien CONWAY
Patrick Dunn
Huw Wallis
Willem Mees Van Der Bijl
Original Assignee
Venipoc 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 AU2015903885A external-priority patent/AU2015903885A0/en
Application filed by Venipoc Pty Ltd filed Critical Venipoc Pty Ltd
Publication of WO2017049363A1 publication Critical patent/WO2017049363A1/fr

Links

Classifications

    • 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
    • B01L3/02—Burettes; Pipettes
    • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B01L3/0217—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type
    • B01L3/0234—Repeating pipettes, i.e. for dispensing multiple doses from a single charge
    • 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
    • B01L3/02—Burettes; Pipettes
    • B01L3/0289—Apparatus for withdrawing or distributing predetermined quantities of fluid
    • B01L3/0293—Apparatus for withdrawing or distributing predetermined quantities of fluid for liquids
    • B01L3/0296—Apparatus for withdrawing or distributing predetermined quantities of fluid for liquids from piercable tubing, e.g. in extracorporeal blood sampling
    • 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
    • B01L3/02—Burettes; Pipettes
    • B01L3/021—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids
    • B01L3/0217—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type
    • B01L3/0224—Pipettes, i.e. with only one conduit for withdrawing and redistributing liquids of the plunger pump type having mechanical means to set stroke length, e.g. movable stops
    • 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

Definitions

  • the present invention relates to the safe and controlled dispensing of blood, particularly for point of care testing and similar applications.
  • Pathology tests such as blood tests, have traditionally been provided using large, centralised pathology laboratory facilities, whether within hospitals or using private providers. These operations continue to play an important role.
  • POC tests point of care tests. These are tests that are provided typically by the clinical personnel providing care to a patient, rather than being conducted in a central facility. POC tests provide clinical personnel with rapid results, to facilitate treatment in a timely way. The range of available tests is increasing significantly and may be expected to continue to increase with further developments.
  • POC tests typically use a test cartridge or test strip, with blood usually taken using a finger prick technique using a disposable lancet. The blood is applied to the test, in some cases a buffer is added, and over a period of seconds to minutes a result is obtained. Each test requires a minimum quantity of blood, which could be any volume between 2.5 and 300 ⁇ , but is usually below 100 ⁇ .
  • POC tests are in acute febrile illness and suspected cases of infectious disease, where there are several POC tests available which allow clinical staff to determine whether the patient has any one of a number of infections which may require rapid assessment, isolation, treatment and contact tracing.
  • Another approach is to take a blood sample by venepuncture in the conventional way, as for conventional pathology laboratory tests.
  • the sample is generally in a container that is specifically designed not to be opened at the point of care and treatment.
  • staff it has been known for staff to pry open the stopper of the blood tube, in order to access the specimen inside with a syringe. This represents a biohazard and blood exposure risk for the operator and their colleagues. Further, this does not provide any mechanism for dispensing the blood in a controlled way.
  • Products exist which enable the operator to access a blood specimen taken by venepuncture inside a vacuette®, vacutainer® or similar tube. These devices are intended for providing a smear of blood or blood film on a microscope slide, for microscopy or similar purposes. Such devices are not suitable for providing specimens for use with POC tests, and do not allow for accuracy in or control of the volume dispensed.
  • [001 0] Another alternative is access the blood specimen in the blood tube with a blood transfer device which allows aspiration of blood into a syringe, which can then be dispensed onto the required POC tests.
  • This approach requires the operator to dispense the blood from a syringe onto the POC test device. This process involves multiple steps and components and does not facilitate the dispensing of a specific measured volume of blood in a safe controlled way. This procedure is not reliable in terms of providing accurate volumes of blood for POC tests and it represents an exposure risk for the operator and their colleagues.
  • the present invention provides a blood dispenser, which receives a tube of blood taken by conventional venepuncture.
  • the dispenser is able to dispense controlled volumes of blood, for example for different POC tests, without requiring any unsafe blood transfer techniques by the operators.
  • the dispenser uses the tube and the corresponding seal as part of a pump for dispensing controlled volumes of blood.
  • the present invention provides a blood dispenser, including an interface for receiving a sample tube containing blood and forming a fluid communication with the tube, a pump for transferring the blood from the tube to a dispensing chamber, and a control mechanism to permit an operator to select a volume of blood to be dispensed, so that the operator operatively selects a volume to be dispensed and operates the pump to release the selected volume of blood.
  • implementations of the present invention allow for the safe dispensing of measured volumes from one blood specimen, using a device which is a single use, disposable product. This allows for various applications, particularly the use of a single venepuncture sample for multiple POC tests.
  • Figure 1 is a series of photographs illustrating the use of an implementation of the present invention.
  • Figures 2A to 2F are views in section showing the operation of the implementation of figure 1 ;
  • Figures 3A to 3C shows external views of an implementation of the present invention
  • Figure 4 is a detailed sectional view illustrating the spike and vent operation of the implementation of figure 2;
  • Figure 5 is a view of a suitable blood tube for use with the present invention.
  • Figure 6 shows detailed views of the valve components of figure 2;
  • Figure 7 is an exploded view of the implementation of figure 2. Detailed Description of the invention
  • vacuette® and vacutainer® products available from Becton Dickinson, it will be appreciated that the invention is in no way limited to such products.
  • other forms of blood sample tube could be used, for example the products supplied by Sarstedt.
  • the tubes may be of the evacuated type, in which the blood is drawn in partly under vacuum, or of a non-evacuated type. While commercially available products are preferred, the implementation could use custom products. Modifications to the implementation would be required, as would be understood by those skilled in the art, corresponding to the design of the sample tubes and their seals.
  • the general concept of the implementations to be described is that a sample of blood is taken from the patient by a conventional venepuncture procedure.
  • the sample is in a tube, which tube is then connected to the dispenser according to the present invention.
  • This enables selected volumes of the sample to be dispensed from the tube through the dispenser, in order to provide blood for multiple POC tests.
  • the blood could be used for other tests, stored, or otherwise dealt with, if required. That is, the usage of the dispenser, and accordingly the scope of the present invention, should not be considered as limited to POC tests.
  • the primary context is the use of the blood for multiple POC tests.
  • FIG. 3A, 3B and 3C illustrates the overall design of an implementation of the present invention.
  • the dispenser generally designated as 10, includes a body 1 1 .
  • a recess 14 allows for a sample tube 20 to be inserted.
  • a discharge tube 1 3 extends from body 1 1 .
  • the outside of body 1 1 is threaded , and carries a dosage collar 12, which is moved up and down to select the required volume of blood to be dispensed.
  • a slot 38 is visible in figure 3C, which allows for dosage collar 12 to interact with the internal mechanism of the dispenser, as will be described in more detail below.
  • the dosage collar 12 travels along the thread in body 1 1 . Volumetric markings 19 can be seen.
  • Key 1 7 serves as a stop, so that the tube/plunger assembly stops when it hits the dosage collar 1 2.
  • Key 17 includes a tab that protrudes through slot 38 in body 1 1 which allows for key 17 to contact dosage collar 12.
  • Handle 29 acts as a stop when spring 1 8 pushes key 17 and needles 31 and 32 upwards.
  • the end of the slot in body 1 1 acts as a stop when depressing tube 20 if dosing collar 12 is set to 100 ⁇ or rotated even further.
  • Figure 7 is an exploded view of the implementation of figure 3. It can be seen that tube 20 has an associated seal 26. In use, vent/spike assembly 30 passes through the seal into tube 20. Valves 23, 24 serve to create the appropriate pressure changes for discharge, as will be described in more detail below. Plunger 40 is attached to vent/spike assembly 30 and operatively travels inside discharge tube 13, against the return force of spring 1 8.
  • Figure 5 shows in more detail a suitable 4 ml blood tube 20, with a seal 26 at the top.
  • seal 26 retains the specimen of blood within the tube, as well as the partial vacuum inside the tube.
  • Figure 1 illustrates, by a series of successive images, the process to be followed when operating a device according to figure 3.
  • Figure 1 shows dispenser 10 ready for use at step 1 .
  • a vacuette® tube 20 is inserted into recess 14 at step 2.
  • dispenser 10 In order for the pump and dispensing mechanism to operate correctly, dispenser 10 must have air removed and blood commencing to flow within the device. To achieve this, tube 20 is depressed, released, and pressed again. In the implementation described, this will remove the air from the dispensing mechanism. This is shown in the 3 images associated with step 3.
  • the present invention is intended to provide the user with greater control over the volume dispensed than current methods such as using a syringe or a pipette.
  • the present invention could be implemented as a less accurate device to allow for reasonable approximate volumes to be dispensed, in order to split a sample among multiple POC tests.
  • the present invention could be implemented so as to dispense a fixed volume, rather than an adjustable volume.
  • the priming cap 15 is removed and discarded. This serves to keep the discharge tube 1 3 clean and free from contamination in storage and the tip and valves protected in transport. It also serves to ensure that there is no accidental discharge of blood until the operator is ready to dispense. To prime the device, the user will need to depress and release tube 20 two or three times and will see blood flow through passage 16 inside transparent discharge tube 13 and into transparent priming cap 15.
  • the tube 20 is depressed and acts as a pump to force the required volume, as selected by the dosage collar 12, from the discharge tube. This may be placed directly onto the test material of a POC test (not shown). This may be repeated as many times as required, consistent with the volume requirements for particular tests, and the quantity of blood in tube 20. The entire assembly is then disposed of in a sharps receptacle or similar facility, as the dispenser and blood tube contain blood and are accordingly a biohazard.
  • POC tests typically have a specific required volume of blood for their correct operation.
  • a typical venepuncture sample will have 2.7ml to 1 0ml of blood.
  • POC tests can require a specific volume between 2.5 and 300 ⁇ , but most are less than 1 00 ⁇ and many are less than 50 ⁇ . It can be seen that the present approach will readily allow for multiple tests to be done in a typical situation.
  • the blood tube has an anti-coagulant inside, for example EDTA or lithium heparin, as is commonly the case commercially, to prevent the blood clotting inside the device prior to application. POC test.
  • an anti-coagulant inside for example EDTA or lithium heparin, as is commonly the case commercially, to prevent the blood clotting inside the device prior to application. POC test.
  • the present implementation is intended for use after a blood sample has been taken by venepuncture, in any conventional way. Millions of such samples are taken in clinics, hospitals and pathology laboratories every day, and so no further discussion of this well-known and widely practiced technique will be provided.
  • the example uses a threaded exterior surface to allow for the adjustment of a selected volume using a dosage collar.
  • Alternative dose selection mechanisms could be used.
  • the collar may include corresponding internal indents, which align with external ribs on body 1 1 , creating a stepped dosing system instead of a continuous thread.
  • Figure 2 illustrates the mechanism of the present implementation, partly in section.
  • Figures 2A to 2F correspond to the stages outlined in figure 1 .
  • the device is ready for use. Priming cap 15 is in place.
  • Discharge tube 13 includes passage 16 for blood to pass through in use. Through recess 14, the vent/spike assembly 30 and tube seal 22 can be seen. As will be explained in more detail below, vent/spike assembly 30 allows for blood 21 to exit tube 20, and for air to enter to prevent a pressure lock in the tube.
  • tube 20 has been attached, and seated inside tube seal 22. This seats the tube so that blood will not discharge backwards through recess 14.
  • Tube 20 and seal 22 form a plunger type structure, with the inside of body 1 1 as the barrel, travelling up and down along with vent/spike assembly 30.
  • Figure 2C illustrates the first step in priming. Tube 20 is pressed down and then released twice. Spring 1 8 provides a return force to take the tube seal 22 and attached plunger 40, and hence tube 20 back to the top. As this occurs, valve 24 is shut. This action creates a vacuum in discharge tube 13 which pulls blood from tube 20, through, spike 32 and key 17, forces valve 23 open and which allows blood to flow into the discharge tube. This will not fill the discharge tube in one go as the volume that is moved is equal to the internal area of the discharge tube 20, not the internal area of the discharge tube 20 plus the internal areas of key 20 spike 32 and key 17, valve 23. Therefore priming the device two or three times is required.
  • Figure 2D illustrates the return to the top.
  • Figure 2E illustrates the dose selection process.
  • the user rotates the dosage collar 1 2 along the external thread, as discussed above, and selects the required volume.
  • the higher up dosage collar 1 2 is rotated, the smaller the travel of tube 20 and hence the smaller the volume dispensed.
  • tube 20 is again depressed. This action forces plunger 40 and seal 22 through the discharge tube. Valve 23 is forced shut by the pressure and valve 24 opens allowing for the selected volume of blood to be expelled from the device from the discharge tube 13.
  • FIG. 2E shows dispenser 1 0 in the process of discharging blood (not shown) from discharge tube 13.
  • Note filter 33 which serves to clean the incoming air so as to prevent contaminants from entering the blood specimen, and prevent any drips or backflow from the vent/spike assembly 30 exiting the device. It may be of any suitable type, for example a LOGICA 24 hour filter, or a cut section of PTFE filter paper, for example rated for 0.2 micron particles.
  • Top seal 23 which is illustratively a duckbill seal, and could also be, but not limited to a ball valve or silicone disc check valve, seals when tube 20 is depressed, and blood is being dispensed ( or used to prime the dispenser).
  • Lower seal 24 seals when the tube 20 is released, and the spring forces the plunger back up.
  • Figure 6 also shows more detailed views of the tube seal 22, which acts as a plunger for the tube /seal assembly in use.
  • FIG. 4 illustrates the operation of vent / spike assembly 30.
  • This may be a pair of tubes, or a single tube divided laterally, or even a co-axial arrangement.
  • Spike 32 allows blood 21 to exit the tube when a reduced pressure is created by spring 18 pushing tube 20 back up, as shown by arrow 34.
  • the vent passage 31 is connected to the external air via filter 33. Thus, as blood 21 is forced out, air is permitted to enter equalising the pressure in tube 20.
  • Implementations of the present invention may be constructed from any suitable materials. It is noted that it is highly preferred that the device be disposable, and consequently long-term durable materials are not required. However, it is critical that the materials chosen do not contaminate or alter the blood specimen in any way which will interfere with the intended tests. Most of the parts of the implementation described may be formed from a suitable hard polymer material, for example ABS, polypropylene or similar materials. Seal components may be formed from appropriate conforming materials, for example silicone, EVA or TPE.
  • the spike, including the long section on the plunger, through which blood will pass, vent and return spring, may be suitably formed from stainless steel. Of course, the invention is not confined to particular materials and any suitable material may be used.
  • Implementations of the present invention may be formed from any suitable material. It is preferred that the discharge tube at least is transparent, so that the blood can be seen when the device is primed and the operator can be sure that the intended volume can be dispensed.
  • the invention in the broadest sense, requires the insertion or connection of a sample tube into the device, and a controlled volume pump mechanism to allow blood to be dispensed.
  • the dispenser may produce a fixed quantity of blood, rather than allow for a quantity to be selected by the operator.
  • An alternative pump mechanism may be used, and in particular, a different sequence and set of seals and valves used. The details of the vent/spike, for example, will depend upon the mechanism and structure of the blood sample containers in use.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

La présente invention concerne un distributeur de sang, comprenant une interface destinée à recevoir un tube échantillon contenant du sang et à former une communication fluidique avec ledit tube, une pompe destinée à transférer le sang du tube vers une chambre de distribution, et un mécanisme de réglage permettant à un opérateur de sélectionner un volume de sang à distribuer, de sorte que l'opérateur sélectionne un volume de sang à distribuer et actionne la pompe pour libérer le volume de sang sélectionné vers ladite chambre de distribution.
PCT/AU2016/050898 2015-09-23 2016-09-23 Distribution volumétrique de sang WO2017049363A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AU2015903885A AU2015903885A0 (en) 2015-09-23 Volumetric dispensing of blood
AU2015903885 2015-09-23

Publications (1)

Publication Number Publication Date
WO2017049363A1 true WO2017049363A1 (fr) 2017-03-30

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ID=58385443

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU2016/050898 WO2017049363A1 (fr) 2015-09-23 2016-09-23 Distribution volumétrique de sang

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WO (1) WO2017049363A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019236098A1 (fr) * 2018-06-08 2019-12-12 Hewlett-Packard Development Company, L.P. Récipients de substance d'impression réglables

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4340390A (en) * 1980-06-16 1982-07-20 Eastman Kodak Company Method and apparatus for metering biological fluids
US5158748A (en) * 1990-01-18 1992-10-27 Mochida Pharmaceutical Co., Ltd. Automated dispensing and diluting system
US5322192A (en) * 1992-07-28 1994-06-21 Automed Corporation Pipetting apparatus
US20060049209A1 (en) * 2004-09-02 2006-03-09 Baker James W System for dispensing biological fluids
US20100288706A1 (en) * 2009-05-14 2010-11-18 Biotechnology Institute, I Mas D, S.L, Method for the preparation of at least one compound from blood, and extraction device for use in the execution of said method

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4340390A (en) * 1980-06-16 1982-07-20 Eastman Kodak Company Method and apparatus for metering biological fluids
US5158748A (en) * 1990-01-18 1992-10-27 Mochida Pharmaceutical Co., Ltd. Automated dispensing and diluting system
US5322192A (en) * 1992-07-28 1994-06-21 Automed Corporation Pipetting apparatus
US20060049209A1 (en) * 2004-09-02 2006-03-09 Baker James W System for dispensing biological fluids
US20100288706A1 (en) * 2009-05-14 2010-11-18 Biotechnology Institute, I Mas D, S.L, Method for the preparation of at least one compound from blood, and extraction device for use in the execution of said method

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019236098A1 (fr) * 2018-06-08 2019-12-12 Hewlett-Packard Development Company, L.P. Récipients de substance d'impression réglables

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