EP4739433A1 - Liquid sample transfer device - Google Patents

Liquid sample transfer device

Info

Publication number
EP4739433A1
EP4739433A1 EP24739170.9A EP24739170A EP4739433A1 EP 4739433 A1 EP4739433 A1 EP 4739433A1 EP 24739170 A EP24739170 A EP 24739170A EP 4739433 A1 EP4739433 A1 EP 4739433A1
Authority
EP
European Patent Office
Prior art keywords
cup
transfer device
sample
base
sample transfer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24739170.9A
Other languages
German (de)
French (fr)
Inventor
Didrik Paus
Jenny MACKENZIE
Sebastian STENMARK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Spinchip Diagnostics AS
Original Assignee
Spinchip Diagnostics AS
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 Spinchip Diagnostics AS filed Critical Spinchip Diagnostics AS
Publication of EP4739433A1 publication Critical patent/EP4739433A1/en
Pending legal-status Critical Current

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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
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/508—Rigid containers without fluid transport within
    • B01L3/5082—Test tubes per se
    • B01L3/50825—Closing or opening means, corks, bungs
    • 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
    • A61B5/150374—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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/10—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices
    • G01N35/1079—Devices for transferring samples or any liquids to, in, or from, the analysis apparatus, e.g. suction devices, injection devices with means for piercing stoppers or septums
    • 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
    • B01L2200/02—Adapting objects or devices to another
    • B01L2200/026—Fluid interfacing between devices or objects, e.g. connectors, inlet details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/04—Closures and closing means
    • B01L2300/041—Connecting closures to device or container
    • B01L2300/044—Connecting closures to device or container pierceable, e.g. films, membranes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0672—Integrated piercing tool

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Pathology (AREA)
  • Physics & Mathematics (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • General Physics & Mathematics (AREA)
  • Clinical Laboratory Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Dermatology (AREA)

Abstract

The invention concerns a sample transfer device for transferring a liquid sample from a sealed test container, the sample transfer device comprising a longitudinal center axis defining an axial direction, a circumferential direction, and a radial direction, a base extending in the radial direction and comprising a base top side facing in the axial direction and a base bottom side facing opposite the axial direction, the base further comprising a neck portion extending in the axial direction from the base top side, and a base protrusion extending from the base bottom side, wherein the neck portion comprises a cup with a cup top rim defining an opening to the cup distal from the base, and a cup bottom defining the bottom of the cup arranged proximal to the base, wherein the base protrusion comprises a cannula extending from the base protrusion in a direction substantially opposite or opposite of the axial direction, and wherein the cannula is in fluid connection with the cup bottom via a fluid conduit, wherein the inner diameter of the cup is larger than the inner diameter of the fluid conduit and configured for retaining a liquid sample within the cup when in use.

Description

Title
LIQUID SAMPLE TRANSFER DEVICE
Technical field
The present invention relates to a liquid sample transfer device, in particular a blood sample transfer device for transferring a blood sample from a test container such as a sealed blood sample tube and for further transfer of the blood sample to a capillary.
Background for the invention
Blood samples are typically collected from patients by venipuncture and collection of blood from a superficial vein in an upper limb. A vein is punctured by a cannula in fluid communication with a test container such as a blood sample tube. The test container is typically a sealed blood sample tube manufactured of sterile glass or plastic closed in one end and with a rubber seal covering the other end creating a vacuum seal. When manufactured, air may be evacuated from the tube creating a vacuum. The amount of air evacuated from the tube may predetermine the amount of blood that will fill the tube before the blood stops flowing. One test container as generally described above is marketed under the brand name “vacutainer”.
A blood sample tube is typically filled with blood by inserting a cannula into a patient’s vein and then connecting the blood sample tube to the cannula and thereby puncturing the rubber seal.
There is a number of devices on the market for transferring a blood sample from sealed blood sample tubes onto or into different sample testing devices.
The U-Pette comprises a base with a cannula protruding on one side in fluid connection with a tube emerging on from the opposite side of the base. The base further comprises two arms with finger grips protruding from the sides of the base. When dispensing blood an operator inserts the cannula through the rubber seal of a blood sample tube, turns the tube up-side down and uses the finger grips to press the device against the rubber seal to create pressure within the blood sample tube. This results in dispensing drops of blood that will hang onto the tube emerging from the base until another drop is pressed out end replaces the hanging drop. The process exposes a free hanging drop of blood which typically drips off the device and risk of spilling is present, https://labcon.com/literatui stteZLabconupette.html
The C-Pette comprises a circular base with a cannula protruding on one side of the circular base in fluid communication with a tube emerging from the opposite side of the base. The cannula is for inserting through the rubber seal of a blood sample tube and the circular base is for pressing or abutting against proprietary test cassette port to create pressure within the blood sample tube and thereby dispensing blood. Pressing down on the C-Pette when not connected to the proprietary cassette may leave a droplet of blood hanging from the device, resulting in risk of spilling. The C- Pette would not be suitable for transfer of blood via a capillary. https://labcon.com/literature/C-Pette/LabconC-Pette.html
DIFF- SAFE is a similar product as the C-Pette, where a cannula is inserted through the rubber seal and is in fluid connection with the opposite side of a base. The base comprises a “tripod” configuration for pressing against a test-plate. This results in that the base is pressed against the rubber seal and a small volume of blood is released from the blood sample tube and drips onto the test-plate. http://www. alpha- scientific. com/Diff-safe2 html
In the particular case where there is need to transfer blood from a test container via a capillary, the above-mentioned products all expose free droplets of blood and are not suitable due to risk of spilling of blood.
HemoCup, blood dispensing cup is described in context with HemoScreen blood analysis apparatus. The HemoCup comprises a cannula for penetrating the rubber seal of a blood test tube. The cannula is in fluid connection with an integrated closed cup or container comprising a side opening for inserting a capillary for further transferring a blood sample to another device via a capillary. The HemoCup allows for sampling blood from a blood test tube by inserting the cannula through the rubber seal of a test tube and then turning the test tube upside down and pressing the test tube with the HemoCup attached towards a flat surface such that drops of blood are forced through the cannula and drips down into the cup that collects the blood. A capillary may then be inserted through the side opening for collecting and transferring the blood sample further. A disadvantage of the HemoCup may be that it is difficult to adjust the volume of blood needed for the capillary, and residual blood within the integrated cup may be of concern when the device is to be disposed due to that residual blood does not get sucked back into the blood test tube when pressure exerted on the seal is released. Residual blood in the cup makes the system vulnerable to spilling of blood. Additionally, it requires manufacture of the closed integrated cup which is challenging and a cost-driving factor. Furthermore, the stability of the HemoCup and blood test tube may not be optimal since the device is intended to be pressed down onto a flat surface without being supported by the operator and entry of a capillary into the integrated closed cup may be restricted. The HemoCup is described in the following document: “Pixcell Medical: HemoCup Instructions for Use Insert”
Thus, all the existing devices on the market may not be suitable for transfer of a blood test from a closed sample tube via a capillary without a high risk of spilling, which is not acceptable for use in environments where hygiene is of high importance, such as hospital emergency rooms. Existing devices may also be impractical in use and difficult to produce.
A first object of the present invention is to provide a device for quick and safe transfer of a blood sample from a closed blood collection tube to a sample collection unit such as a capillary, which is easy and cost-efficient to produce and with low risk of spilling. A second object of the present invention is to provide a method for safe transfer of a blood sample from a closed blood collection tube to a capillary with reduced or eliminated risk of spilling using a device which is easy and economical to produce.)
A third object of the present invention is to provide a method for transfer of a liquid sample from a test tube by use of the invention.
Summary of the invention
With the above-mentioned challenges and known solutions in mind, the present invention provides a device for transfer of a liquid test sample from a test container, in particular for transfer of a blood sample from a blood test tube via a sample collection unit such as a capillary and to an apparatus for analysis.
The present invention is set forth and characterized in the main claims, while the dependent claims describe other characteristics of the invention.
In a first aspect, the invention concerns a sample transfer device for transferring a liquid sample from a sealed test container, the sample transfer device comprising a longitudinal center axis defining an axial direction, a circumferential direction, and a radial direction, a base extending in the radial direction and comprising a base top side facing in the axial direction and a base bottom side facing opposite the axial direction, the base further comprising a neck portion extending in the axial direction from the base top side, and a base protrusion extending from the base bottom side, wherein the neck portion comprises a cup with a cup top rim defining an opening to the cup distal from the base, and a cup bottom defining the bottom of the cup arranged proximal to the base, wherein the base protrusion comprises a cannula extending from the base protrusion in a direction substantially opposite or opposite of the axial direction, and wherein the cannula is in fluid connection with the cup bottom via a fluid conduit, wherein the inner diameter of the cup is larger than the inner diameter of the fluid conduit and configured for retaining a liquid sample within the cup when in use.
The larger diameter of the cup than the fluid conduit facilitates that a volume of blood may be contained inside the cup.
The cup may preferably have a diameter large enough to accommodate insertion of a sample collection unit such as a capillary into the cup. The sample collection unit may be manufactured of materials such as glass, plastics or other suitable materials. The sample collection unit may rely on the capillary effect to draw a liquid sample into it.
The skilled person would know that the terms test container, test tube, liquid sample tube, blood sample tube, blood collection tube may be used for describing the same object herein. The skilled person would know that the terms liquid sample, blood sample may be used to describe the same subject matter herein.
In one example the cup is configured with a diameter and/or cross-sectional area that is adapted for reducing or eliminating risk of spilling of a liquid sample from the cup. The cup may be sized to hold the liquid sample securely by means of the capillary effect and surface tension of the liquid sample. The diameter or the cross-sectional area may vary depending on for example the surface tension displayed by the liquid sample. The liquid sample may be retained in the cup if the device is held with the opening of the cup facing down towards the floor/ground.
In one exemplary configuration of the sample transfer device the inner diameter of the cup bottom is in the range 1mm - 20mm, 1,5mm - 15mm, 2mm - 13mm, 2,5mm
- 12mm, 3mm - 11mm, 3,2mm-9mm, 3,4mm - 7mm or 3,5mm - 5mm. When kept within these ranges the capillary effect and surface tension of the liquid sample may contribute to keep a volume of blood within the cup and reduce or eliminate risk of spilling and facilitates entering of a sample collection unit such as a capillary into the cup.
In one exemplary configuration of the sample transfer device the cup top rim has a diameter or cross-sectional area equal or larger than the cup bottom.
In one exemplary aspect of the sample transfer device the extent in the axial direction of the cup from the cup bottom to the cup top rim is in the range 2mm - 30mm, 3mm
- 25mm, 4mm - 20mm, 4,5mm - 15mm, 5mm - 11mm, 6mm - 9mm or 6,5mm - 8mm. This results in a size suitable for obtaining an appropriate volume of blood in the cup.
In one exemplary aspect of the sample transfer device the volume of the cup is between lOpL - 500pL, 15pL - 350pL, 20pL - 300pL, 30pL - 250pL, 35pL - 200pL, 40pL - 150pL, 45pL - 120pL, 50pL - lOOpL, 55pL - 90pL, 60pL - 85pL or 70pL - 80pL.
In one exemplary aspect of the sample transfer device the cross-sectional area of the cup is equal distal from the cup bottom compared to the cross-sectional area of the cup proximal to the cup bottom resulting in straight edges of the cup that are parallel to the axial direction.
In one exemplary aspect of the sample transfer device the cross-sectional area of the cup is larger distal from the cup bottom compared to the cross-sectional area of the cup proximal to the cup bottom, resulting in a conical shape of the cup.
In one exemplary aspect of the sample transfer device the cross-sectional area of the cup is equal at the cup bottom and the cup top rim.
In one exemplary aspect of the sample transfer device the cross-sectional area of the cup is larger at the cup top rim than at the cup bottom. In one exemplary aspect of the sample transfer device the cup bottom has a rounded profile. This facilitates easier filling of a sample collection unit such as a capillary, since the opening to the capillary will not easily be obstructed when fully inserted into the cup.
In one exemplary aspect of the sample transfer device the base comprises at least two arms spread apart and extending from the base bottom side in a direction substantially opposite of the axial direction, the arms may function as a guide for the user when fitting the sample transfer device on a closed blood collection tube.
In one exemplary aspect of the sample transfer device each of the arms further comprises finger grips extending in the radial direction from each of the arms at an end distal from the base for providing user with a firm grip of the device.
In one exemplary aspect of the sample transfer device the sample transfer device comprises a ring structure connected to the arms and extending in the circumferential direction, the ring structure having a central opening suitable for accepting insertion of an end of the test container. The ring structure provides stiffness to the device and further means for guiding the blood collection tube towards the cannula.
In one exemplary aspect of the sample transfer device the ring structure comprises a ring structure top proximal to the base, and a ring structure bottom distal from the base, and wherein the cannula extends a maximum length from the base protrusion to a vertical level of the ring structure bottom, or to a vertical level between the ring structure top and the ring structure bottom protecting both the user from being stung by the cannula and protecting the cannula against potential damage from contact with external factors.
In one exemplary aspect of the sample transfer device the cannula extends 3mm - 40mm, 5mm - 35mm, 7,5mm - 15mm, or 9mm - 13mm or 10mm-12mm from the base protrusion.
In one exemplary aspect of the sample transfer device the cup is made of a transparent material for easy inspection of if the device has already been used or to determine the volume of blood in the cup.
In one exemplary aspect of the sample transfer device the arms are flexible for ergonomic reasons or to use them to press against a test container to stabilize it.
In one exemplary aspect of the sample transfer device the volume displaced when base protrusion is pressed against the seal is equal to the volume of the cup for easy filling of the cup with an appropriate volume of blood.
In one exemplary aspect of the sample transfer device the cup displays a plurality of cup protrusions on the internal side wall of the cup configured for retaining a liquid sample within the cup. The protrusions may be circular and extending in the circumferential direction c, they may be a ribbed protrusion, triangular, square, rectangular, oblong, hexagonal or any other suitable shape. The protrusions may be confined to an area of the inner surface of the cup rather than extend circumferentially, for example one protrusion may cover an area of 0,1mm2 - 1mm2 and be spaced apart from neighboring protrusions. The protrusions may protrude about 0,1mm - 1,5mm, 0,2mm - 1mm, 0,4mm - 0,7mm from the internal surface of the cup.
In one exemplary aspect of the sample transfer device the cup bottom comprises at least one cup bottom stopper arranged at the cup bottom and protruding 0,5mm-4mm, 0,5mm-3mm, 0,5mm-2mm or lmm-2mm towards the cup top rim, thereby ensuring that there is space between a sample collection unit and the cup bottom even if the sample collection unit is fully inserted into the cup. This secures sufficient flow of liquid from the cup into a sample collection unit.
The sample transfer device may comprise from 1-10, 2, 3, 4, 5, 6, 7, 8, or 9 bottom stoppers.
In one exemplary aspect of the sample transfer device the cup further comprises, a cup edge defining a transition from a cup lower part to a cup upper part, wherein the cup lower part is arranged proximal to the cup bottom and the cup upper part is arranged distal from the cup bottom, and wherein the diameter or cross-sectional area of the cup upper part is larger distal from the cup edge than proximal to the cup edge, and wherein an angle between a side wall of the cup upper part and the longitudinal center axis is larger than an angle between a side wall of the cup lower part and the longitudinal center axis, and thereby configured for retaining a liquid sample within the cup lower part when in use. A liquid sample retained in the cup lower part may be protected by the side wall of the cup upper part. The cup upper part may aid in correct insertion of a sample collection unit such as a capillary due to the angle of the side wall which may function as a funnel to make aiming and insertion the sample collection easier.
In one exemplary aspect of the sample transfer device the angle between the side wall of the cup upper part and the longitudinal center axis is from 15°-70°, 20°-65°, 25°- 60°, 30°-55°, 35°-50°, 37°-45°, 38°-42° or is about 40°, and wherein the angle between the side wall of the cup lower part and the longitudinal center axis is from 0°-25°, 3°-20°, 5°-17°, 7°-15°, 8°-12° or is about 10°.
In one exemplary aspect of the sample transfer device the volume of the cup lower part is from 10pL-70pL, 20pL-60pL, 25pL-55pL, 28pL-50pL, 30pL-40pL, 31pL- 37pL, 32pL-35pL or is about 33pL.
In one exemplary aspect of the sample transfer device the volume of the cup upper part is from 10pL-80pL, 20pL-70pL, 30pL-60pL, 35pL-55pL, 40pL-50pL, 43pL- 47pL or is about 44pL. In one embodiment the present invention concerns a method for transferring a liquid sample from a test container sealed with a seal by using the sample transfer device as described in any of the aspects above, or combination thereof, wherein the method comprises the following steps:
A. piercing the seal on the test container by inserting the cannula through the seal and into the liquid sample,
B. optionally turning the test container with the sample transfer device such that the liquid sample covers at least the tip of the cannula
C. applying a force to the sample transfer device such that the base protrusion presses against the seal, and thereby
D. obtaining a liquid sample in the cup of the sample transfer device,
E. inserting a sample collection unit into the cup for filling the sample transfer unit with at least a part of the liquid sample, and
F. using the sample collection unit for transferring at least a part of the liquid sample to another device for collecting at least a part of the liquid sample.
The sample collection unit may for example be a capillary, which relies on the capillary effect to draw the liquid sample into the capillary or it may be a needle coupled to a syringe for drawing the sample.
In one exemplary aspect of the method, the method further comprises the following step between step C and D:
- visually aligning the level of the liquid sample to the cup edge, for obtaining a suitable volume of liquid sample.
In one exemplary aspect of the method, the method further comprises the following step after step E or F : releasing the force applied in step C for allowing any residual liquid sample in the cup to be withdrawn into the test container.
Brief description of the figures
Fig. 1 shows a side view of an embodiment the sample transfer device.
Fig. 2 shows a side view of an embodiment the sample transfer device.
Fig. 3 A shows a side view of an embodiment the sample transfer device.
Fig. 3B shows a detailed side view of the cup and entrance of the sample transfer device.
Fig. 4 shows a side view of the sample transfer device Fig. 5 shows a perspective view of the sample transfer device.
Fig. 6A shows a top view of the sample transfer device with a cup bottom stopper arranged at the cup bottom.
Fig. 6B shows a bottom view of the sample transfer device.
Fig. 7 shows a cross sectional view of the sample transfer device.
Fig. 8 shows a cross-sectional view of the sample transfer device connected to a test container.
Fig. 9A shows the sample transfer device connected to a test tube with the cannula submerged in the liquid sample.
Fig. 9B shows the sample transfer device connected to a test tube with the cannula submerged in the liquid sample and a capillary inserted into the cup for transfer of the liquid sample.
Fig. 10 show the sample transfer device with protrusions on the internal surface of the cup.
Detailed description of the invention
In the following, specific embodiments of the invention will be described in more detail with reference to the drawings. However, the invention is not limited to the embodiments and illustrations contained herein. It is specifically intended that the invention includes modified forms of the embodiments, including portions of the embodiments and combinations of elements of different embodiments. It should be appreciated that in the development of any actual implementation, as in any engineering or design project, specific decisions must be made to achieve the developer’s specific goals, such as compliance with system and/or business-related constraints. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication and manufacture for the skilled person having the benefit of this disclosure.
Figs. 1-10 shows different aspects and embodiments of a sample transfer device 1.
Fig. 1 illustrates an example embodiment of a sample transfer device 1 comprising a base 100 displaying a base top side 101 facing in the axial direction z and a base bottom side 102 facing the opposite direction. The sample transfer device has a longitudinal centre axis AL which defines an axial direction z, a circumferential direction c and a radial direction r. The base 100 extends in the radial direction r and may have an oblong shape. It can also be envisaged that the base 100 has another suitable shape such as square, rectangular or circular.
A hollow neck portion 107 extends in the axial direction z from the base 100 to a cup top rim 124 and defines a cup 121. The cup top rim 124 defines the top of the cup 121 and an opening 120 to the cup 121. The opening 120 is located distal from the base 100. The cup comprises a cup bottom 122 located proximal to the base 100 and may be located centrally on the base top side 101.
From the base bottom side 102 a base protrusion extends in the opposite direction of the axial direction z. The base protrusion 105 may be located centrally on the base bottom side 102. The base protrusion 105 may comprise a fluid conduit 110 which is in fluid connection with a cannula 115 extending from the base protrusion. This establishes a fluid connection from the tip of the cannula 115 to the cup bottom 122 allowing for fluid such as a blood sample to enter the cup 121 via the cannula 115. Fig. 1 also shows that the cup bottom 122 has a rounded profile.
The cup 121 has a volume and shape adapted to receive and hold a liquid sample 170 without risk of spilling. Without being bound by theory the liquid sample 170 may be held in place due to its viscosity and the surface tension displayed by the liquid sample.
At the lateral sides of base 100 two arms 130 may extend in the direction opposite of the axial direction z. The arms 130 comprise an arm proximal end 133 where the arms 130 are fixed to the base 100 and an arm distal end 132 where finger grips 140 may be attached and extending in the radial direction r. The skilled person acknowledges that the finger grips may be dimensioned to a suitable size for ergonomically accommodating the fingers of a user of the sample transfer device 1.
The sample transfer device 1 may optionally comprise a ring structure 131 connected to the arms 130 and extending circumferentially in the radial direction r. The ring structure 131 may be located at a mid-portion of the arms 130, occupying a part of the region between the arms distal end 132 and the arms proximal end 133.
The ring structure 131 defines an opening 150 which provides access to the tip of the cannula 115 for a test container 50 as shown in figs. 8, 9A and 9B.
Fig. 1 shows an embodiment of the sample transfer device 1 where the side walls of the cup 121 almost parallel to the axial direction z. An embodiment of the sample transfer device where the side walls of the cup 121 are parallel to the axial direction z may also be envisaged, resulting in that the cross-sectional area of the cup 121 is equal at the cup bottom 122 and the cup top rim 124. Fig. 2 illustrates an exemplary embodiment of the sample transfer device 1 where the cross-sectional area of the cup 121 at the cup top rim 124 is larger than the cross- sectional area at the cup bottom 122.
As illustrated in fig. 4 the ring structure may comprise a ring structure top 131a and a ring structure bottom 131b.
Now turning back to fig. 2 which illustrates that the cannula 115 extends to a vertical level that lies between the ring structure top 131a and the ring structure bottom 131b. This ensures that the cannula 115 is protected from potential damage from external objects and that a user of the sample transfer device 1 is protected from the possible injuries that could be caused by the sharp pointy cannula 115 when handling the sample transfer device 1.
Fig. 3 A and 3B illustrates another example embodiment of the sample transfer device 1 where the cup comprises a distinct cup edge 123 which defines a transition from a cup lower part 121a and a cup upper part 121b. The cup lower part is arranged proximal to the base 100 and the cup upper part is arranged distal to the base 100.
As best shown in fig. 3B the cup lower part 121a displays a side wall 121 al and the upper cup part 121b displays a side wall 121b 1. The angle between the side wall 12 lai and the longitudinal centre axis AL is denoted ay and the angle between the side wall 12 lb 1 and the longitudinal centre axis AL is denoted ax. The angle ax may be larger than the angle ay i.e the cross-sectional area of the cup upper part 121b is progressively larger than the cross-sectional area of the cup lower part 121a as the distance from the base 100 increases.
Without being bound by theory it is believed that this configuration may result in improved retention of a liquid sample 170 in the cup lower part 121a since a capillary effect may be reduced or absent above the cup edge 123. This means that any tendency of the liquid sample 170 to be drawn upwards on the side wall 12 lb 1 is minimized or eliminated.
The cup edge 123 may be a sharp edge or have a more rounded or gradual profile.
Fig. 5 provides a side view of the sample transfer device 1 displaying the opening 120 of the neck portion 107 and the base protrusion 105 with the cannula 115 extending to a vertical level of the ring structure 131 as well as the finger grips 140 connected to the arms 130.
Fig. 6A shows a top view of an embodiment of the sample transfer device 1 according to the invention displaying the base 100 and the opening 120 centrally placed, as well as the ring structure 131 and the finger grips 140. Also shown is a cup bottom stopper 126 arranged at the cup bottom 122. The cup bottom stopper 126 protrudes from the cup bottom towards the cup top rim 124. The cup bottom stopper 126 may extend for example 0,5mm - 2 mm, for example 1mm from the cup bottom 122 in the axial direction z. This ensures that there is always space between a sample collection unit 160, such as a capillary, since the cup bottom stopper 126 prevents the sample collection unit 160 from reaching the cup bottom 122 when inserted fully into the cup 121. A free flow of liquid into the sample collection unit 160 is thus ensured.
Fig. 6B illustrates a bottom view of an example of the sample transfer device 1 comprising the base 100, the ring structure 131 and with the base protrusion 105 and the cannula 115 centrally placed. The base protrusion 105 is configured with a larger diameter than the cannula 115 and is adapted to abut against a seal 55 of a test container 50. The base protrusion 105 may further be configured to have a size such that the volume displaced within the test container when pressed against a flexible seal 55 equals the volume of the cup 121 or the cup lower part 121a. The volume of the liquid test sample to be transferred through the cannula 115 to the cup 121 or cup lower part 121a may thereby be adapted to a suitable volume, for example equal to or smaller than the volume of the cup 121 or the cup lower part 121a.
Fig. 7 shows an example of the sample transfer device 1 comprising the arms 130 and finger grips 140 but no ring structure 131. This configuration may provide arms 130 with more ability to flex and even touch and grip a test container 50 if an appropriate amount of pressure is asserted on the arms 130 by a user of the sample transfer device 1. Shown in fig. 7 is an example of the sample transfer device comprising the cup edge 123. The skilled person would acknowledge that all examples of cups 121 presented herein would be compatible with an embodiment of the sample transfer device 1 without the ring structure 131 being present.
Fig. 8 illustrates the sample transfer device 1 attached to a test container 50 with the cannula 115 inserted through a seal 55 of the test container 50. Also shown is that the base protrusion 105 is pressing the seal 55 down and partially into the test container 50 by exerting a force thereto. The skilled person would know that this would result in a build-up of pressure within the test container 50 which in turn would allow for content of the container 50 to be expelled.
Fig. 9A shows the sample transfer device 1 attached to a test container 50 with the cannula 115 inserted through the seal. The test container 50 with the sample transfer device 1 is tilted such that the liquid sample 170 within the test container 50 covers the tip of the cannula 115, also illustrated by the liquid meniscus 171 rising to the bottom of the test container 50 which is in a higher position than the seal in figs. 9A and 9B.
Fig. 9B shows that a sample collection unit 160 is inserted into the cup 121 of the sample transfer device. The sample transfer unit 160 may be a capillary or any other device suitable for insertion into the cup 121 and collecting liquid sample 170 that has been transferred from the test container 50 to the cup 121 via the cannula 115 and the fluid conduit 110.
Fig. 10 illustrates the sample transfer device 1 displaying cup protrusions 125 on the inside surface of the cup lower part 121a. The cup protrusions 125 function to keep the liquid sample within the cup lower part 121a. Without being bound by theory it is thought that the increased surface area is at least partly responsible for this effect. It is to be understood that the cup protrusions 125 may be displayed at all embodiments disclosed herein. It is also to be understood that the cup protrusions 125 does not need to be confined to the cup lower part 121a, but may also appear at the cup upper part 121b or at the entire surface of the cup 121 where there is no cup edge 123.
With reference to all the figures discussed above a method according to the following sequential steps allows a user to exploit the sample transfer device 1 :
A. piercing the seal 55 on the test container 50 by inserting the cannula 115 through the seal 55 and into the liquid sample 170,
B. optionally turning the test container 50 with the sample transfer device 1 such that the liquid sample 170 covers the cannula 115
C. applying a force to the sample transfer device 1 such that the base protrusion 105 presses against the seal 55, and thereby
D. obtaining a liquid sample 170 in the cup 121 of the sample transfer device 1,
E. inserting a sample collection unit 160 into the cup 121 for filling a sample transfer unit 160 with at least a part of the liquid sample 170, and
F. using the sample collection unit 160 for transferring the liquid sample 170 to another device for collecting the liqud sample. the method may further comprise the following step between step C and D:
- visually aligning the level of the liquid sample 170 to the cup edge 123, for obtaining a suitable volume of liquid sample 170. the method may further comprise the following step after step E or F: releasing the force applied in step C for allowing any residual liquid sample 170 in the cup 121 to be withdrawn into the test container 50.
It is appreciated that certain features of the invention, which, for clarity, have been described above in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which, for brevity, have been described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. List of numerical references:

Claims

1.
A sample transfer device (1) for transferring a liquid sample from a sealed test container (50), the sample transfer device (1) comprising a longitudinal center axis (AL) defining an axial direction (z), a circumferential direction (c), and a radial direction (r), a base (100) extending in the radial direction (r) and comprising a base top side (101) facing in the axial direction (z) and a base bottom side (102) facing opposite the axial direction (z), the base (100) further comprising a neck portion (107) extending in the axial direction (z) from the base top side (101), and a base protrusion (105) extending from the base bottom side (102), wherein the neck portion (107) comprises a cup (121) with a cup top rim (124) defining an opening (120) to the cup (121) distal from the base (100), and a cup bottom (122) defining the bottom of the cup (121) arranged proximal to the base (100), wherein the base protrusion (105) comprises a cannula (115) extending from the base protrusion (105) in a direction substantially opposite of the axial direction (z), and wherein the cannula (115) is in fluid connection with the cup bottom (122) via a fluid conduit (110), wherein the inner diameter of the cup (121) is larger than the inner diameter of the fluid conduit (110) and configured for retaining a liquid sample within the cup (121) when in use.
2.
The sample transfer device (1) according to claim 1, wherein the cup (121) is configured with a diameter and/or cross-sectional area that is adapted for reducing or eliminating risk of spilling of a liquid sample from the cup (121).
3.
The sample transfer device (1) according to claim 1, wherein the inner diameter of the cup bottom (122) is in the range 1mm - 20mm, 1,5mm - 15mm, 2mm - 13mm, 2,5mm - 12mm, 3mm - 11mm, 3,2mm-9mm, 3,4mm - 7mm or 3,5mm - 5mm.
4.
The sample transfer device (1) according to any of the preceding claims, wherein the extent in the axial direction (z) of the cup (121) from the cup bottom (122) to the cup top rim (124) is in the range 2mm - 30mm, 3mm - 25mm, 4mm - 20mm, 4,5mm - 15mm, 5mm - 11mm, 6mm - 9mm or 6,5mm - 8mm.
5. The sample transfer device (1) according to any of the preceding claims, wherein the volume of the cup (121) is between lOpL - 500pL, 15pL - 350pL, 20pL - 300pL, 30pL - 250pL, 35pL - 200pL, 40pL - 150pL, 45pL - 120pL, 50pL - lOOpL, 55pL - 90pL, 60pL - 85pL or 70pL - 80pL.
6.
The sample transfer device (1) according to any of the preceding claims, wherein the cross-sectional area of the cup (121) is equal to or larger distal from the cup bottom (122) compared to the cross-sectional area of the cup (121) proximal to the cup bottom (122).
7.
The sample transfer device (1) according to any of the preceding claims, wherein the cup bottom (122) has a rounded profile.
8.
The sample transfer device (1) according to any of the preceding claims, wherein the base (100) comprises at least two arms (130) spread apart and extending from the base bottom side (102) in a direction substantially opposite of the axial direction (z).
9.
The sample transfer device (1) according to claim 8, wherein each of the arms (130) further comprises finger grips (140) extending in the radial direction (r) from each of the arms (130) at an end distal from the base (100).
10. The sample transfer device (1) according to claim 8 or 9, wherein the sample transfer device (1) comprises a ring structure (131) connected to the arms (130) and extending in the circumferential direction (c), the ring structure having a central opening 150 suitable for accepting insertion of an end of the test container (50).
11.
The sample transfer device (1) according to claim 10, wherein the ring structure (131) comprises a ring structure top (131a) proximal to the base (100), and a ring structure bottom (131b) distal from the base (100), and wherein the cannula (115) extends a maximum length from the base protrusion (105) to a vertical level of the ring structure bottom (131b), or to a vertical level between the ring structure top (131a) and the ring structure bottom (131b).
12.
The sample transfer device (1) according to any of the preceding claims, wherein the cup (121) is made of a transparent material. The sample transfer device (1) according to any of the preceding claims, wherein the arms (130) are flexible.
14.
The sample transfer device (1) according to any of the preceding claims, wherein the volume displaced when base protrusion (105) is pressed against the seal (55) is equal to the volume of the cup (121).
15.
The sample transfer device (1) according to any of the preceding claims, wherein the cup (121) displays a plurality of cup protrusions (125) on the internal side wall of the cup (121) configured for retaining a liquid sample within the cup (121).
16.
The sample transfer device (1) according to any of the preceding claims, wherein the cup bottom (122) comprises at least one cup bottom stopper (126) arranged at the cup bottom (122) and protruding 0,5mm-2mm towards the cup top rim (124).
17.
The sample transfer device (1) according to any of the preceding claims, wherein the cup (121) further comprises, a cup edge (123) defining a transition from a cup lower part (121a) to a cup upper part (121b), wherein the cup lower part (121a) is arranged proximal to the cup bottom (122) and the cup upper part (121b) is arranged distal from the cup bottom (122), and wherein the cross-sectional area of the cup upper part (121b) is larger distal from the cup edge (123) than proximal to the cup edge (123), and wherein an angle (ax) between a side wall (121b 1) of the cup upper part (121b) and the longitudinal center axis (AL) is larger than an angle (ay) between a side wall (121 al ) of the cup lower part (121a) and the longitudinal center axis (AL), and thereby configured for retaining a liquid sample within the cup lower part (121a) when in use.
18.
The sample transfer device (1) according to claim 17, wherein the angle (ax) between the side wall (12 lb 1) of the cup upper part (121b) and the longitudinal center axis (AL) is from 15°-70°, 20°-65°, 25°-60°, 30°-55°, 35°-50°, 37°-45°, 38°-42° or is about 40°, and wherein the angle (ay) between the side wall (121 al ) of the cup lower part (121a) and the longitudinal center axis (AL) is from 0°-25°, 3°-20°, 5°-17°, 7°-15°, 8°-12° or is about 10°.
19.
The sample transfer device (1) according to any of the preceding claims 17-18, wherein the volume of the cup lower part (121a) is from 10pL-70pL, 20pL-60pL, 25pL-55pL, 28pL-50pL, 30pL-40pL, 3 lpL-37pL, 32pL-35pL or is about 33pL.
20.
The sample transfer device (1) according to any of the preceding claims 17-19, wherein the volume of the cup upper part (121b) is from 10pL-80pL, 20pL-70pL, 30pL-60pL, 35pL-55pL, 40pL-50pL, 43pL-47pL or is about 44pL.
21.
A method for transferring a liquid sample from a sealed test container (50) sealed with a seal (55) by using the sample transfer device (1) according to any of the preceding claims, wherein the method comprises the following steps:
A. piercing the seal (55) on the sealed test container (50) by inserting the cannula (115) through the seal (55) and into the liquid sample,
B. optionally turning the test container (50) with the sample transfer device 1 such that the liquid sample (170) covers at least the tip of the cannula (115)
C. applying a force to the sample transfer device (1) such that the base protrusion (105) presses against the seal (55), and thereby
D. obtaining a liquid sample in the cup (121) of the sample transfer device (1),
E. inserting a sample collection unit into the cup (121) for filling the sample collection unit with at least a part of the liquid sample (170), and
F. using the sample collection unit 160 for transferring at least a part of the liquid sample (170) to another device for collecting at least a part of the liquid sample (170).
22.
The method according to claim 21, wherein the method further comprises the following step between step C and D:
- visually aligning the level of the liquid sample to the cup edge (123), for obtaining a suitable volume of liquid sample.
23.
The method according to claim 21 and/or 22, wherein the method further comprises the following step after step E or F: releasing the force applied in step C for allowing any residual liquid sample in the cup (121) to be withdrawn into the test container (50).
EP24739170.9A 2023-07-06 2024-07-02 Liquid sample transfer device Pending EP4739433A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NO20230762A NO349086B1 (en) 2023-07-06 2023-07-06 Liquid sample transfer device
PCT/EP2024/068546 WO2025008321A1 (en) 2023-07-06 2024-07-02 Liquid sample transfer device

Publications (1)

Publication Number Publication Date
EP4739433A1 true EP4739433A1 (en) 2026-05-13

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EP (1) EP4739433A1 (en)
KR (1) KR20260035980A (en)
CN (1) CN121532251A (en)
NO (1) NO349086B1 (en)
WO (1) WO2025008321A1 (en)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE8808138U1 (en) * 1988-06-24 1988-10-27 Ballies, Uwe, Dr. med., 2300 Kiel Device for separating the serum separated from the blood clot by centrifugation of a sample tube
US5286453A (en) * 1992-04-02 1994-02-15 Pope Carolyn M Device for dispensing a biological fluid from a sealed vacuum tube
US6426049B1 (en) * 1999-07-09 2002-07-30 Becton, Dickinson And Company Collection assembly
US6817256B2 (en) * 2001-02-27 2004-11-16 Alfa Wassermann, Inc. Pipette sampling system
EP2249701B1 (en) * 2008-03-05 2020-04-29 Becton, Dickinson and Company Capillary action collection container assembly
US20120024416A1 (en) * 2010-07-29 2012-02-02 Helena Laboratories Corporation System and method for dispensing fluid from a container and into a fluid receptacle
EP3087010B1 (en) * 2013-12-27 2018-12-12 William Beaumont Hospital Container closure, container assembly and method for utilizing the same
WO2019213397A1 (en) * 2018-05-04 2019-11-07 Becton, Dickinson And Company Closure for a biological fluid collection device

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KR20260035980A (en) 2026-03-13
NO20230762A1 (en) 2025-01-07
NO349086B1 (en) 2025-09-15
CN121532251A (en) 2026-02-13

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