Transfer device and transfer method for transferring at least one volume of a cell suspension

Abstract

A transfer method and a transfer device (110) for transferring at least one volume of a cell suspension from a first sample tube (112) to a second sample tube (114) are disclosed. The transfer device (110) comprises: - at least one first cannula (116) configured for transferring the at least one volume of the cell suspension from the first sample tube (112) to the second sample tube (114), wherein the first cannula (116) comprises at least one first cannula tip (118) configured for at least partially penetrating into an interior (120) of the first sample tube (112), wherein the first cannula (116) further comprises at least one second cannula tip (122) configured for at least partially penetrating into an interior (124) of the second sample tube (114), wherein the first cannula tip (118) and the second cannula tip (122) are in direct fluidic connection (126) with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube (112) to the second sample tube (114); and - at least one second cannula (130) configured for providing at least one pressure port (132) to the interior (120) of the first sample tube (112).

Description

[0001] Transfer device and transfer method for transferring at least one volume of a cell suspension

[0002] Technical Field

[0003] The present invention refers to a transfer device and a transfer method for transferring at least one volume of a cell suspension, specifically whole blood. The transfer device and the transfer method, as an example, may be used in the field of medical laboratories in which typically whole blood has to be handled for the purpose of analysis and / or diagnostics. However, other types of applications comprising the transfer of cell suspensions are also feasible.

[0004] Background art

[0005] In the field of medical laboratories, generally, a plurality of samples, for example liquid samples of blood, blood plasma, blood serum, urine, saliva or other types of bodily fluid, have to be handled, preferably automatically. Diagnostic samples often may comprise cell suspensions, such as whole blood. In routine diagnostics, it is desired to draw as few primary blood sample tubes from a patient as possible. Thus, in the medical laboratory, blood samples may need to be transferred from one primary sample tube to one or more secondary sample tubes for the purpose of analysis and / or diagnostics. Automated solutions for serum or plasma transfer between sample tubes, e.g. after centrifugation of blood samples, are generally known. However, transferring exact volumes of cell suspensions, such as whole blood, e.g. liquid samples comprising living blood cells, may require manual work by trained and qualified personnel.

[0006] WO 2005 / 066627 Al discloses a device for separating plasma from whole blood having an evacuated primary collection chamber capable of fluid communication through a porous filter to an evacuated secondary collection chamber. An agglutinating agent is provided within the primary collection chamber so as to aggregate blood cells within a whole blood sample. The porous filter has a pore size which is small enough to capture the aggregated blood cells therein, yet large enough to permit plasma to transfer there through under pressures associated with conventional evacuated blood collection tubes. The primary and secondary collection chambers may be provided in separate containers or tubes, with transfer occurring there between through a transfer device including the porous filter therein.

[0007] WO 2016 / 061601 Al discloses a handling device for medical technology, with a main body part and a front wall which define a receiving space. A cannula protrudes with its proximal cannula end into the receiving space. A hose-like sleeve is held with its distal sleeve end on at least one holding element of the holding device, which holding element is formed or arranged directly on the front wall. The holding element bears externally on the sleeve in a contact area. Moreover, a method for producing a handling device of this type is described.

[0008] US 2018 / 0296748 Al describes compositions and methods for separating a sample of whole blood or bone marrow aspirate into a fraction rich in at least one of platelets and pluripotent cells. A sample of whole blood can be centrifuged in a collection tube comprising a separator substance formulated to settle between the PRP fraction and the at least one other fraction. Preferably, centrifugation is completed without substantial activation of platelets. Optionally, the separator substance could be hardened to form a solid barrier that allows removal of all or substantially all of the platelets in the PRP fraction without remixing of the PRP fraction with the at least one other fraction. Transfer devices and methods are also described in which a sterile sample can be transferred from a separation / preparation container (e.g., vacutainer) to a consumer or other container (e.g., dropper).

[0009] US 4,697,622 A discloses an implantable medication infusion device including a pump that provides medication at below atmospheric pressure from a reservoir to a catheter in response to a controller. The infusion device includes a septum fitting having a septum and a poppet that is located in a cavity that is in communication with reservoir. A fill needle of a passive filling device opens poppet and a vent needle of the filling device is also opened to establish passive flow of medication from a vial into the reservoir.

[0010] Despite the advantages achieved by known methods and devices, several technical challenges remain. Specifically, transfer of cell suspensions, such as whole blood, e.g. liquid samples comprising living blood cells, in medical laboratories may require either expensive robotics solutions or manual work by trained and qualified personnel. This may be even more important since the blood transfer between open sample tubes has generally to be performed under a safety cabinet, e.g. a bio safety cabinet, and / or in other sterile or semi- sterile environments. Problem to be solved

[0011] It is therefore desirable to provide methods and devices which at least partially address the above-mentioned technical challenges. Specifically, a transfer method and a transfer device shall be proposed which allow transfer of cell suspensions in an easy and comprehensive way, in particular without the need for highly trained or qualified personnel.

[0012] Summary

[0013] This problem is addressed by a transfer device and a transfer method for transferring at least one volume of a cell suspension with the features of the independent claims. Advantageous embodiments which might be realized in an isolated fashion or in any arbitrary combinations are listed in the dependent claims as well as throughout the specification.

[0014] As used in the following, the terms “have”, “comprise” or “include” or any arbitrary grammatical variations thereof are used in a non-exclusive way. Thus, these terms may both refer to a situation in which, besides the feature introduced by these terms, no further features are present in the entity described in this context and to a situation in which one or more further features are present. As an example, the expressions “A has B”, “A comprises B” and “A includes B” may both refer to a situation in which, besides B, no other element is present in A (i.e. a situation in which A solely and exclusively consists of B) and to a situation in which, besides B, one or more further elements are present in entity A, such as element C, elements C and D or even further elements.

[0015] Further, it shall be noted that the terms “at least one”, “one or more” or similar expressions indicating that a feature or element may be present once or more than once typically will be used only once when introducing the respective feature or element. In the following, in most cases, when referring to the respective feature or element, the expressions “at least one” or “one or more” will not be repeated, non-withstanding the fact that the respective feature or element may be present once or more than once.

[0016] Further, as used in the following, the terms "preferably", "more preferably", "particularly", "more particularly", "specifically", "more specifically" or similar terms are used in conjunction with optional features, without restricting alternative possibilities. Thus, features introduced by these terms are optional features and are not intended to restrict the scope of the claims in any way. The invention may, as the skilled person will recognize, be performed by using alternative features. Similarly, features introduced by "in an embodiment of the invention" or similar expressions are intended to be optional features, without any restriction regarding alternative embodiments of the invention, without any restrictions regarding the scope of the invention and without any restriction regarding the possibility of combining the features introduced in such way with other optional or non-optional features of the invention.

[0017] In a first aspect of the present invention, a transfer device for transferring at least one volume of a cell suspension, specifically whole blood, from a first sample tube to a second sample tube is disclosed.

[0018] The term “transfer” or “transferring” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of changing a position of an object or sample. Specifically, a transfer of an object or a sample may comprise a change of position of the object or sample from a first position to a second position being different from the first position. Liquid samples may generally be comprised by one or more sample tubes configured for collecting, handling and / or storing the liquid samples. The transfer of a liquid sample may specifically comprise a change of a sample tube comprising the liquid sample. For example, the transfer of a liquid sample may comprise at least partially removing the liquid sample from a first sample tube and introducing at least a part of the removed liquid sample into a second sample tube different from the first sample tube.

[0019] The term “transfer device” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device configured for transferring samples, specifically liquid samples. The transfer device may be configured for transferring a liquid sample, specifically the cell suspension, from one sample tube comprising the liquid sample, specifically the cell suspension, to at least one other sample tube. The transfer of the transfer device may be a complete transfer of the entire liquid sample comprised by a sample tube and / or a partial transfer, specifically such that at least a part of the liquid sample remains in the sample tube after transfer. The transfer device may specifically be configured for splitting liquid samples, specifically for splitting the cell suspension from one sample tube into one or more other sample tubes. The transfer device may be configured for clean and / or sterile transfer of the liquid sample, specifically of the cell suspension, more specifically of whole blood. The transfer device may be configured for transferring the liquid sample, specifically the cell suspension, from one sterile sample tube to at least one other sterile sample tube without opening the sterile sample tubes. The transfer device may be configured for transferring liquid samples, specifically the cell suspension, without a need for manual pipetting. The transfer device may specifically be a passive transfer device. The passive transfer device may be operated by a user of the transfer device. Thus, the transfer of liquid samples with the transfer device may be initiated and at least partially driven by a user of the transfer device.

[0020] The term “volume” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an amount of a fluid, specifically of a liquid sample. The volume of the cell suspension to be transferred from the first sample tube to the second sample tube may comprise the entire volume and / or a part of the volume of the cell suspension comprised by the first sample tube.

[0021] The term “cell suspension” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary liquid sample comprising one or more cellular compounds. The cell suspension may specifically be a heterogeneous mixture of at least one liquid comprising one or more cellular compounds, specifically solid cellular compounds. The cell suspension may specifically comprise single cells and / or cell aggregates. The cell suspension may comprise cellular compounds obtained from at least one biological source, specifically directly obtained from the respective source or indirectly by pretreatment and / or a sample preparation workflow. For example, the cell suspension may comprise an arbitrary aliquot part or aliquant part of a biological fluid which is directly a bodily fluid or which is derived from a bodily fluid, such as by one or more pre-processing steps, e.g. by centrifugation. For example, the cell suspension may comprise at least one liquid sample, which, optionally, may be or may comprise an agitated growth medium, and one or more cellular blood components, such as erythrocytes, leukocytes and / or thrombocytes, also denoted as red blood cells, white blood cells and / or platelets, respectively. The cell suspension may be or may comprise an aliquot of whole blood. Alternatively or additionally, the cell suspension may comprise plasma or serum with separation gel.

[0022] The term “whole blood” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a body fluid from a circulatory system of a human being or animal. The whole blood may specifically comprise cellular blood components suspended in blood plasma. The term “sample tube” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an arbitrary shaped container for a sample, specifically a liquid sample. Specifically, the sample tube may be used in the field of medical and / or chemical laboratories. In particular, the sample tube may be an arbitrary individual container for transporting, storing and / or processing a content, e.g. a sample, received by the sample tube. For example, the sample tube may be a cylindrical container, e.g. a cylindrical tube having a circular or polygon cross-section and a longitudinal axis of extension. For example, the sample tube may be an ampoule. In particular, the sample tube may comprise a body, e.g. a cylindrically and / or tube-shaped body, for containing the sample and may comprise an open end, such as an opening, pointing upwards. As an example, the body may have a flat or rounded bottom. Further, as an example, the sample tube may also comprise a closure, such as a foil and / or cap for sealing the sample tube. In particular, the sample tube may be a piece of laboratory glass- or plasticware, optionally comprising a cap on its upper end. For example, the sample tube may be a glass or a transparent plastic tube. The sample tube may specifically have a tube axis, such as an axis through a center of the sample tube. In particular, the tube axis may be an axis of symmetry, such as an axis through a geometrical center of the sample tube or through a center of gravity or mass of the sample tube. For example, the tube axis may be an axis through a geometrical center of area, surface, position or mass of the sample tube.

[0023] The term “first sample tube” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sample tube comprising the liquid sample, specifically the cell suspension, more specifically whole blood, to be transferred. Similarly, the term “second sample tube” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a sample tube for receiving the transferred liquid sample, specifically cell suspension, more specifically whole blood. The second sample tube may specifically be a vacuum sample tube. The second sample tube may have a pressure difference of at least 100 Pa, specifically of at least 1 kPa, more specifically of at least 10 kPa, most specifically of at least 15 kPa, compared to the first sample tube, specifically a negative pressure difference compared to the first sample tube. In other words, the pressure of the second sample tube may be lower than the pressure of the first sample tube. For example, atmospheric pressure may prevail in the first sample tube. For sample tubes having a volume of 10 ml, as an example, the second sample tube may have a negative pressure difference of 75 mmHg, which is approximately 10 kPa, compared to the first sample tube. For sample tubes having a volume of 5 ml, as an example, the second sample tube may have a negative pressure difference of 50 mmHg, which is approximately 6.6 kPa, compared to the first sample tube. The terms “first” and second” may be used for nomenclature only and specifically may not indicate any numbering of the sample tubes. For example, the transfer device may be configured for transferring the cell suspension from one first sample tube to multiple second sample tubes, e.g. to two or more second sample tubes.

[0024] The transfer device comprises: at least one first cannula configured for transferring the at least one volume of the cell suspension from the first sample tube to the second sample tube, wherein the first cannula comprises at least one first cannula tip configured for at least partially penetrating into an interior of the first sample tube, wherein the first cannula further comprises at least one second cannula tip configured for at least partially penetrating into an interior of the second sample tube, wherein the first cannula tip and the second cannula tip are in direct fluidic connection with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube; and at least one second cannula configured for providing at least one pressure port to the interior of the first sample tube, wherein the pressure port is connectable to at least one pressure applicator, wherein the pressure port comprises at least one connecting element configured for connecting to the at least one pressure applicator.

[0025] The term “cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a hollow needle. The cannula may comprise a lumen, such as a cavity, a channel or a capillary within the cannula, configured for receiving liquid samples, specifically the cell suspension, more specifically whole blood. The cannula may specifically be configured for conducting liquid samples, specifically the cell suspension, more specifically whole blood, along a predetermined path. In particular, upon entry into the cannula, the liquid sample, specifically the cell suspension, more specifically whole blood, may flow through the lumen of the cannula, thus being transported by the cannula along the predetermined path. The transport of the liquid sample, specifically of the cell suspension, more specifically of whole blood, through the cannula may be at least partially promoted by at least one of capillary force and pressure difference, as will be outlined in further detail below. The cannula may have an elongated shape having a circular, oval or polygonal profile, wherein a length of a longitudinal extension of the cannula exceeds a diameter of the profile by at least 10 times. The profile of the cannula may vary over a length of the cannula. The cannula may comprise at least one solid and / or rigid material, such as a metal material, e.g. stainless steel. The cannula may comprise at least one beveled end, specifically at least one sharp beveled end. The beveled end of the cannula may comprise one or more of a standard bevel form, a short bevel form and / or a true short bevel form. The cannula may be configured for conducting liquid samples, specifically the cell suspension, more specifically whole blood, between two ends of the cannula, e.g. between a beveled end and an end opposing the beveled end. The beveled end of the cannula may be referred to as “cannula tip”. The cannula tip may be configured for penetrating through a layer, such a septum of a sample tube, e.g. a rubber or a rubber-like septum of a sample tube.

[0026] The term “first cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a cannula for transfer of liquid samples, specifically for transfer of the at least one volume of the cell suspension. The first cannula may specifically provide a transfer path for transfer of the cell suspension, specifically of whole blood, from the first sample tube to the second sample tube. The first cannula may be or may comprise a single piece, such as a single cannula having two beveled ends, or, alternatively, a combination of two or more pieces, such as two or more cannulas, each of the cannulas having at least one beveled end and being in fluidic connection with each other, as will be outlined in further detail below.

[0027] The first cannula may have two beveled ends, specifically two sharp beveled ends. The term “first cannula tip” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one beveled end of the first cannula for penetrating the first sample tube. The term “second cannula tip” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one beveled end of the first cannula for penetrating the second sample tube. The second cannula tip may be arranged on an opposing side of the first cannula tip. The first cannula tip and the second cannula tip may be realized by a single cannula or, alternatively, by two cannulas. For example, the first cannula tip and the second cannula tip each may comprise at least one cannula, each cannula having at least one beveled end. Alternatively, the first cannula tip and the second cannula tip may comprise two beveled ends of a single cannula

[0028] The term “penetrating” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of entering an object or space being defined by at least one limiting boundary. The penetrating may specifically comprise piercing the limiting boundary to create at least one passageway for entering the object or space within the limiting boundary. For example, the sample tube, such as the first sample tube and / or the second sample tube, may comprise a cap having a septum, e.g. a rubber or a rubber-like septum, for sealing an opening of the sample tube. The penetrating may comprise piercing through the septum of the cap of the sample tube in order to enter an interior of the sample tube.

[0029] The term “interior” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to an inner space, specifically an inner space of the sample tube. The interior of the sample tube may be defined by circumferential walls of the sample tube and, optionally, by at least one cap. The interior of the first sample tube may comprise the cell suspension, specifically whole blood. The transferred volume of the cell suspension, specifically of whole blood, may be introduced into the interior of the second sample tube. The interior of the sample tube may specifically be hermetically sealed from an ambient environment of the sample tube, e.g. in order to avoid contamination of the cell suspension, specifically of whole blood, comprised by the respective sample tube.

[0030] The term “direct fluidic connection” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one fluid passageway without altering of properties of the fluid passing there through. The direct fluidic connection may comprise at least one fluid passageway without affecting or influencing the fluid passing through the passageway, specifically without altering a composition of the fluid passing through the passageway. The direct fluidic connection of the first cannula tip and the second cannula tip may comprise at least one fluid passageway enabling transfer of the volume of the cell suspension such that the cell suspension, specifically the whole blood, passing through the fluid passageway is not affected or influenced by the pass-through. The direct fluidic connection may specifically be free of any filtering or selective transfer means, e.g. free of any filter for filtering cellular blood components. The cell suspension, specifically the whole blood, passing through the direct fluidic connection of the first cannula tip and the second cannula tip may not be altered in its composition. For example, the direct fluidic connection may be free of any filtering or selective transfer means selectively transferring certain components of the cell suspension. Specifically, the cell suspension passing through the direct fluidic connection of the first cannula tip and the second cannula tip may leave the second cannula tip with the same composition as introduced via the first cannula tip.

[0031] The direct fluidic connection of the first cannula tip and the second cannula tip may be configured for permitting transfer of cells, specifically cellular blood components, comprised by the cell suspension, specifically by whole blood. Alternatively or additionally, the direct fluidic connection of the first cannula tip and the second cannula tip may be configured for avoiding altering a composition of the transferred volume of the cell suspension, specifically with respect to cells comprised by the cell suspension. For example, whole blood may be transferred by the direct fluidic connection of the first cannula tip and the second cannula tip from the first sample tube to the second sample tube. The direct fluidic connection may specifically avoid coagulation of the transferred whole blood.

[0032] The term “second cannula” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a cannula for gas exchange, specifically air exchange. The second cannula may be configured for introducing gas, e.g. air from an ambient environment of the first sample tube, into the first sample, specifically into the interior of the first sample tube. The second cannula may be configured for air exchange between the interior of the first sample tube and an ambient environment of the first sample tube. The second cannula may specifically connect the interior of the first sample tube with an ambient environment. The second cannula may be configured for pressure equalization using gas exchange, specifically air exchange. For example, a pressure drop in the interior of the first sample tube due to the transfer of the volume of the cell suspension may be at least partially equalized or compensated by air exchange with the ambient environment via the second cannula. Additionally or alternatively, a pressure inside the interior of the first sample tube may be enhanced via the second cannula using gas exchange, specifically air exchange.

[0033] A length of a penetrating part of the second cannula penetrating the interior of the first sample tube may exceed a length of a penetrating part of the first cannula tip penetrating into the interior of first sample tube. The penetrating part of the first and second cannula may refer to the part of the first and second cannula entering into the first sample tube when the transfer device is applied to the first sample tube. Preferably, the first cannula tip penetrating into the interior of first sample tube may be flush with an interior side of a septum or sealing element of the first sample tube. The second cannula may penetrate into the interior of the first sample tube. Thus, in this configuration, the transfer device may enable a complete removal of the sample in the first sample tube. Alternatively or additionally, the first cannula, specifically the first cannula tip, and the second cannula may extend essentially parallel into the interior of the first sample tube. The term “essentially parallel”, as used herein, may refer, without limitation, to a parallel configuration or a configuration deviating from the parallel configuration by no more than 10°, specifically by no more than 5°, more specifically by no more than 1°. In this configuration, a distance between the first cannula, specifically the first cannula tip, and the second cannula may be at least one times of a diameter of at least one of the first cannula and the second cannula, specifically at least two times of a diameter of at least one of the first cannula and the second cannula. The diameter may specifically comprise one of an inner diameter and an outer diameter of the respective cannula. In case the first cannula and the second cannula have different diameter, the distance may specifically be based on the diameter of the larger cannula. The distance between the first cannula and the second cannula may ensure that the pierced septum or sealing element of the first and / or second sample tube is tightly sealed after removal of the transfer device from the respective sample tube. Further, the distance between the first cannula and the second cannula may enable a transfer of the volume from the first sample tube to the second sample tube even if the sample tubes are not held vertically, in particular even if the sample tubes are held horizontally, during transfer of the volume.

[0034] The term “pressure port” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to at least one interface for introducing and / or removing gas, specifically air. The pressure port may specifically be at least one interface of the second cannula for introducing and / or removing gas, specifically air, from the interior of the first sample tube via the second cannula. The pressure port of the second cannula may be a stationary pressure port, specifically providing permanent air inlet via the second cannula when the transfer device is applied to the first sample tube.

[0035] The term “connectable” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a characteristic or suitability of an element for establishing a connection with at least one further element or device. Specifically, the pressure port may be configured for establishing a connection, in particular an airtight connection, with the pressure applicator. The connection may specifically be a removable connection such that the connected pressure applicator can be applied and removed from the pressure port, e.g. by a user of the transfer device. The connection between the pressure port and the pressure applicator may be formed by the connecting element.

[0036] The term “connecting element” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a specific interfacing element. Specifically, the connecting element may comprise at least one adapter of fitting configured for connecting to the pressure applicator. The connecting element may provide a removable connection between the pressure applicator and the pressure port, specifically between the pressure applicator and the second cannula. The connecting element may comprise at least one element selected from the group consisting of a pipe connecting element; a luer lock connecting element; other thread supported connections.

[0037] The transfer device may further comprise at least one retention vessel configured for preventing leakage from the second cannula, specifically at least one retention vessel in fluid connection with the second cannula preventing leaking of the cell suspension from the second cannula. The retention vessel may be or may comprise a vessel or container receiving cell suspension spilled through the second cannula. The retention vessel may be in connection with the second cannula, specifically with the pressure port of the second cannula. The retention vessel may specifically avoid spilling of the cell suspension when using the transfer device.

[0038] The transfer device may further comprise at least one pressure applicator configured for adjusting a pressure in the first sample tube via the pressure port of the second cannula. The term “pressure applicator” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device for adjusting and / or equalizing a pressure via gas exchange. The pressure applicator may be configured for introducing gas, e.g. air from an ambient environment, into the first sample tube, specifically into the interior of the first sample tube. The pressure applicator may specifically be configured for engaging with the pressure port of the second cannula. The pressure applicator may specifically be in connection with the second cannula via the pressure port and with an ambient environment. The pressure applicator may further be configured for introducing gas, e.g. air from an ambient environment, via the pressure port of the second cannula into the first sample tube, specifically into the interior of the first sample tube. For example, the pressure applicator may be or may comprise at least one rubber bulb. Other examples are, however, also feasible. At least one of the first cannula and the second cannula may be at least partially covered with at least one polymer sleeve, specifically at least one rubber sleeve. The polymer sleeve may be configured for sealing the covered cannula. For example, the second cannula tip may be at least partially covered with at least one polymer sleeve, specifically at least one rubber sleeve. The polymer sleeve may be configured for sealing the covered second cannula tip, specifically for preventing leakage of the cell suspension. The polymer sleeve may specifically be or may comprise at least one rubber coating. The polymer sleeve may prevent the cell suspension, specifically the whole blood, from escaping of the covered cannula. The polymer sleeve may ensure cleanness and sterility of the covered cannula.

[0039] Alternatively or additionally, at least one of the first cannula and the second cannula may be covered by at least one protective cover. The protective cover is configured for providing puncture protection, specifically puncture protection for the user of the transfer device. For example, the second cannula tip may be covered by at least one protective cover, the protective cover being configured for providing puncture protection, specifically puncture protection for the user of the transfer device. Additionally, the protective cover may be sealed by an additional cover or lid sealing the cannulas covered by the protective cover from the environment. Thus, in this example, the sealed protective cover may replace the polymer sleeve on the cannulas while still ensuring clean and sterile environment for the cannulas.

[0040] The transfer device may further comprise at least one seal cover, specifically a stopper and / or a cap, configured for sealing an opening of the first sample tube. The term “seal cover” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a device for engaging with a sample tube. The seal cover may specifically be configured for being applied on a sample tube, such as on top of an opening of the sample tube, specifically irrespective of having a cap on the sample tube.

[0041] The first cannula may protrude through the seal cover. The first cannula tip may be arranged on a first side of the seal cover facing the interior of the first sample tube. The second cannula tip may be arranged on a second side of the seal cover opposite to the first side. Thus, the second cannula tip may be arranged on the second side of the seal cover facing the interior of the second sample tube. The transfer device may further comprise at least one tube sleeve configured for at least partially surrounding the first sample tube. The tube sleeve may specifically ensure correct positioning of the transfer device with respect to the first sample tube.

[0042] In a further aspect of the present invention, a transfer method for transferring at least one volume of a cell suspension, specifically whole blood, from a first sample tube to a second sample tube is disclosed. The transfer method may specifically comprise using the transfer device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below. Thus, for definitions of terms with respect to the transfer device and / or possible embodiments of the transfer device, reference is made to the description of the transfer device above.

[0043] The transfer method comprises the following method steps, which specifically may be performed in the given order. However, a different order may also be possible. It may further be possible to perform one, more than one or even all of the method steps repeatedly. Further, it may be possible to perform two or more of the method steps in a fashion overlapping in time and / or fully or partially simultaneously.

[0044] The method comprises: i) applying at least one transfer device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further detail below, to the first sample tube comprising the cell suspension, such that the at least one first cannula tip of the first cannula and the second cannula at least partially penetrate into the interior of the first sample tube; ii) applying the second sample tube to the transfer device, such that the at least one second cannula tip of the first cannula at least partially penetrates into the interior of the second sample tube, wherein the first cannula tip and the second cannula tip are in direct fluidic connection with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube; and iii) transferring the at least one volume of the cell suspension from the first sample tube to the second sample tube.

[0045] The term “applying” as used herein is a broad term and is to be given its ordinary and customary meaning to a person of ordinary skill in the art and is not to be limited to a special or customized meaning. The term specifically may refer, without limitation, to a process of putting into operation or bringing in action the transfer device. The applying of the transfer device to one of the first sample tube and the second sample tube may comprise attaching the transfer device to one of the first sample tube and the second sample, respectively. The transfer device may specifically be applied to the first sample tube with the first cannula tip and the second cannula facing towards the first sample tube. The second sample tube may specifically be applied to the transfer device with the second cannula tip facing towards the second sample tube.

[0046] The transferred volume of whole blood may specifically be a homogenous aliquot of an initial sample of whole blood in the first sample tube. Alternatively or additionally, step iii) may comprise a direct transfer of the volume of whole blood from the first sample tube to the second sample tube, specifically without any intermediate sample preparation step, more specifically without centrifugation. Alternatively or additionally, the transfer of the volume of whole blood may comprise a homogenous transfer, specifically without altering or modifying a composition of the transferred volume of whole blood. Thus, the method according to the present invention may transfer a homogenous aliquot of whole blood from the first sample tube to the second sample tube, in contrast to the prior art, specifically in contrast to US 2018 / 0296748 Al which only transfers cell fractions. The method may specifically avoid any intermediate sample preparation step, such as centrifugation or the like. The method may also provide a direct and homogenous transfer of whole blood, in particular a transfer of the red blood cell fraction in the transferred volume.

[0047] The method may further comprise, specifically prior to step i), providing the first sample tube and the second sample tube. The first sample tube may specifically be provided with the cell suspension, specifically whole blood, comprised in the interior of the first sample tube. The first sample tube and the second sample tube may be provided with a pressure difference. Alternatively or additionally, the method may comprise generating a pressure difference between the first sample tube and the second sample tube using the pressure applicator connected to the pressure port. For example, the first sample tube and the second sample tube may be provided with a predetermined pressure difference to transfer a predetermined amount of an initial sample of whole blood from the first sample tube to the second sample tube. A pressure in the first sample tube exceeds a pressure in the second sample tube. Thus, the method may specifically comprise using the first sample tube with an overpressure compared to the second sample tube, wherein the pressure in the first sample tube may be generated using the pressure applicator connected to the pressure port and / or can be maintained during transfer of the volume of whole blood via the pressure applicator connected to the pressure port, e.g. using the rubber bulb or a syringe connected to the connecting element. Thus, specifically, in the method described in US 2018 / 0296748 Al, the sample tubes are provided with a pressure difference to transfer the entire sample from the first sample tube to the second sample tube. The method according to the present invention may comprise providing the sample tubes with a predetermined pressure difference to ensure that a predetermined volume of the whole blood is transferred from the first sample tube to the second sample tube. Additionally, the pressure difference may be maintained and / or adjusted via the pressure port of the transfer device, e.g. in case the transferred volume of whole blood is less than the envisaged transfer volume.

[0048] As an example, the first sample tube may be provided with ambient pressure. The second sample tube may be provided with vacuum. Specifically, the second sample tube may be provided with a pressure difference of at least 100 Pa, specifically of at least 1 kPa, more specifically of at least 10 kPa, most specifically of at least 15 kPa, compared to the first sample tube, specifically a negative pressure difference compared to the first sample tube. In other words, the pressure of the second sample tube may be lower than the pressure of the first sample tube. For example, atmospheric pressure may prevail in the first sample tube. For sample tubes having a volume of 10 ml, as an example, the second sample tube may have a negative pressure difference of 75 mmHg, which is approximately 10 kPa, compared to the first sample tube. For sample tubes having a volume of 5 ml, as an example, the second sample tube may have a negative pressure difference of 50 mmHg, which is approximately 6.6 kPa, compared to the first sample tube.

[0049] As outlined above, the transfer device may comprises the at least one pressure applicator configured for adjusting a pressure in the first sample tube via the pressure port of the second cannula. The method may comprise, specifically in step iii), adjusting the pressure in the first sample tube using the pressure applicator. For example, the method may comprise, specifically in step iii), compensating a pressure decrease due to the transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube using the pressure applicator. Alternatively or additionally, step iii) may comprise pressurizing the first sample tube using the pressure applicator. The pressurizing may specifically comprise increasing a pressure in the first sample tube, e.g. such that the at least one volume of the cell suspension is transferred form the first sample tube to the second sample tube. Alternatively or additionally, the pressure in the first sample tube may be adjusted via the pressure port of the second cannula such that at least one predetermined volume of the cell suspension is transferred from the first sample tube to the second sample tube.

[0050] In a further aspect of the present invention, a use of the transfer device according to the present invention, such as according to any one of the embodiments disclosed above and / or according to any one of the embodiments disclosed in further details below, for transferring whole blood from a first sample tube to a second sample tube. The transfer device and the transfer method according to the present invention may provide a large number of advantages over known methods and devices. Specifically, the transfer device and the transfer method according to the present invention may enable lab workers or healthcare workers, such as worker in a diagnostic laboratory having a lower level of training for volume transfer and / or sterile working, to transfer cell suspension, specifically blood, from one sample tube to another sample tube without opening the sterile sample tubes and / or without the need for manual pipetting. Thus, specifically, the transfer device and the transfer method according to the present invention may ensure that the volume of whole blood is homogenously transferred from the first sample tube to the second sample tube and that a predetermined volume of whole blood is transferred, which may be controlled according to the provided or applied pressure difference between the first and second sample tubes. Additionally, the transfer device and the transfer method may be applied in a clean environment without special focus on sterile or semi-sterile working and / or without special personal protective measures with regard to blood borne pathogens for the user. The transfer device and the transfer method may specifically be used for release assays, wherein in order to avoid false reactive results in a release assay, the cannulas may be provided in a clean and sterile state, specifically with the same grade or class as blood collection devices.

[0051] The transfer device may specifically be configured for penetrating the septum of the first sample tube by means of two sharp cannulas, wherein the first cannula may be used for transfer of the cell suspension, specifically of whole blood, wherein the second cannula may be used for air equalization. The user of the transfer device may be protected from injuries by the protective cover, e.g. by a prick protection. The first sample tube having the transfer device applied thereto may be vertically with the second cannula tip pointing downwards. The first cannula tip and the second cannula tip are in direct fluidic connection with each other. The second cannula tip may be surrounded by a polymer sleeve, e.g. a rubber coating, which specifically may prevent the cell suspension, specifically the whole blood, from escaping and may be displaceable for being displaced upon applying the transfer device with the second cannula tip to the second sample tube. The second cannula tip may be surrounded, e.g. on the outside of the second cannula tip, by a protective cover providing puncture protection to the user. The second tube may then be pushed onto the second cannula tip of the transfer device. The second sample tube may be provided as a vacuum tube. In the first sample tube, ambient pressure may prevail. Thus, the pressure difference between the first sample tube and the second sample tube may cause the cell suspension, specifically the whole blood, to be drawn from the first sample tube to the second sample tube. The underpressure in the first sample tube resulting from the volume transfer may be compensated via the second cannula, specifically being connected to the ambient air. The transfer device may specifically prevent spillage of the cell suspension, specifically of whole blood, from the first sample tube by the retention vessel being in connection with the pressure port of the second cannula and / or by a polymer sleeve, e.g. a rubber coating, on the second cannula tip. If the transferred volume in the second sample tube may not be reached, e.g. being visually usually indicated by a mark on the second sample tube, the first sample tube may be pressurized with overpressure via the second cannula.

[0052] The transfer device and the transfer method according to the present invention may specifically be used, as an example, in conjunction with Interferon Gamma Release assays (IGRA) which are common in diagnosis of latent tuberculosis, SARS-CoV-2, Lyme, cytomegalovirus (CMV). Alternatively or additionally, the transfer device and the transfer method may be used in conjunction with other cytokine or chemokine release assays were whole blood may be used for specific or unspecific T-cell stimulation. Alternatively or additionally, the transfer device and the transfer method may be used in conjunction with whole blood based molecular diagnostic assays, where, specifically, splitting of the original blood sample may be necessary, e.g. to perform multiple assays on different diagnostic analyzers in parallel. The transfer device may be provided with clean and sterile cannulas in order to avoid false reactive results in the release assay, e.g. by ensuring that the cannula are of the same grade or class as the blood collection device. The polymer sleeve, e.g. a rubber sleeve, on the cannulas may ensure cleanness and sterility. The protective cover may be additionally sealed by a cover or lid, specifically sealing the cannulas underneath and protecting and sealing the cannulas from the environment. The sealed protective cover may replace the polymer sleeve on the cannulas. The transfer device and the transfer method, additionally or alternatively, may be used in conjunction with blood smear diagnostic procedures.

[0053] The transfer device and the transfer method according to the present invention may be compatible with all standard sample tubes, e.g. standard blood collection sample tubes, which have a rubber or rubber-like septum designed to be punctured by a venipuncture device. A distance between the first cannula and the second cannula may be varied in order to achieve compatibility with all common sample tube types. The transfer device and the transfer method may also be used invention with sample tubes comprising blood plasma comprising anti-coagulants, e.g. EDTA, heparin or citrate. Additionally or alternatively, the transfer device and the transfer method may be used to transfer plasma or serum with separation gel, e.g. after separation and / or centrifugation, from the first sample tube to the second sample tube. The transfer device and the transfer method according to the present invention may specifically be used in any diagnostic laboratory where transfer of cell suspension, such as whole blood, from one sample tube to one or more second sample tubes, e.g. specific stimulations sample tubes, is required.

[0054] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0055] Embodiment 1 : A transfer device for transferring at least one volume of a cell suspension, specifically whole blood, from a first sample tube to a second sample tube, the transfer device comprising: at least one first cannula configured for transferring the at least one volume of the cell suspension from the first sample tube to the second sample tube, wherein the first cannula comprises at least one first cannula tip configured for at least partially penetrating into an interior of the first sample tube, wherein the first cannula further comprises at least one second cannula tip configured for at least partially penetrating into an interior of the second sample tube, wherein the first cannula tip and the second cannula tip are in direct fluidic connection with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube; and at least one second cannula configured for providing at least one pressure port to the interior of the first sample tube, wherein the pressure port is connectable to at least one pressure applicator, wherein the pressure port comprises at least one connecting element configured for connecting to the at least one pressure applicator.

[0056] Embodiment 2: The transfer device according to the preceding embodiment, wherein the connecting element comprises at least one element selected from the group consisting of: a pipe connecting element; a luer lock connecting element; other thread supported connections.

[0057] Embodiment 3 : The transfer device according to any one of the preceding embodiments, wherein a length of a penetrating part of the second cannula penetrating the interior of the first sample tube exceeds a length of a penetrating part of the first cannula tip penetrating into the interior of first sample tube.

[0058] Embodiment 4: The transfer device according to any one of the preceding embodiments, wherein the first cannula, specifically the first cannula tip, and the second cannula extend essentially parallel into the interior of the first sample tube, wherein a distance between the first cannula, specifically the first cannula tip, and the second cannula is at least one times of a diameter of at least one of the first cannula and the second cannula, specifically at least two times of a diameter of at least one of the first cannula and the second cannula.

[0059] Embodiment 5 : The transfer device according to any one of the preceding embodiments, wherein the pressure port of the second cannula is a stationary pressure port.

[0060] Embodiment 6: The transfer device according to any one of the preceding embodiments, wherein the direct fluidic connection of the first cannula tip and the second cannula tip is configured for permitting transfer of cells, specifically cellular blood components, comprised by the cell suspension, specifically by whole blood.

[0061] Embodiment 7 : The transfer device according to any one of the preceding embodiments, wherein the direct fluidic connection of the first cannula tip and the second cannula tip is configured for avoiding altering a composition of the transferred volume of the cell suspension, specifically with respect to cells comprised by the cell suspension.

[0062] Embodiment 8 : The transfer device according to any one of the preceding embodiments, further comprising at least one retention vessel configured for preventing leakage from the second cannula, specifically at least one retention vessel in fluid connection with the second cannula preventing leaking of the cell suspension from the second cannula.

[0063] Embodiment 9: The transfer device according to the preceding embodiment, wherein the retention vessel is in connection with the second cannula.

[0064] Embodiment 10: The transfer device according to any one of the preceding embodiments, further comprising at least one pressure applicator configured for adjusting a pressure in the first sample tube via the pressure port of the second cannula.

[0065] Embodiment 11 : The transfer device according to any one of the preceding embodiments, wherein at least one of the first cannula and the second cannula is at least partially covered with at least one polymer sleeve, specifically at least one rubber sleeve, the polymer sleeve being configured for sealing the covered cannula.

[0066] Embodiment 12: The transfer device according to any one of the preceding embodiments, wherein the second cannula tip is at least partially covered with at least one polymer sleeve, specifically at least one rubber sleeve, the polymer sleeve being configured for sealing the covered second cannula tip, specifically for preventing leakage of the cell suspension. Embodiment 13 : The transfer device according to any one of the preceding embodiments, wherein at least one of the first cannula and the second cannula is covered by at least one protective cover, the protective cover being configured for providing puncture protection.

[0067] Embodiment 14: The transfer device according to any one of the preceding embodiments, wherein the second cannula tip is covered by at least one protective cover, the protective cover being configured for providing puncture protection.

[0068] Embodiment 15 : The transfer device according to any one of the preceding embodiments, further comprising at least one seal cover, specifically a stopper and / or a cap, configured for sealing an opening of the first sample tube.

[0069] Embodiment 16: The transfer device according to the preceding embodiment, wherein the first cannula protrudes through the seal cover.

[0070] Embodiment 17: The transfer device according to any one of the two preceding embodiments, wherein the first cannula tip is arranged on a first side of the seal cover facing the interior of the first sample tube, wherein the second cannula tip is arranged on a second side of the seal cover opposite to the first side.

[0071] Embodiment 18: The transfer device according to any one of the three preceding embodiments, wherein the second cannula tip is arranged on a second side of the seal cover facing the interior of the second sample tube.

[0072] Embodiment 19: The transfer device according to any one of the preceding embodiments, wherein the first cannula tip and the second cannula tip each comprise at least one cannula.

[0073] Embodiment 20: The transfer device according to any one of the preceding embodiments, further comprising at least one tube sleeve configured for at least partially surrounding the first sample tube.

[0074] Embodiment 21 : The transfer device according to any one of the preceding embodiments, wherein the transfer device is a passive transfer device, specifically a passive transfer device being operated by a user of the transfer device. Embodiment 22: A transfer method for transferring at least one volume of a cell suspension, specifically whole blood, from a first sample tube to a second sample tube, the method comprising: i) applying at least one transfer device according to any one of the preceding embodiments to the first sample tube comprising the cell suspension, such that the at least one first cannula tip of the first cannula and the second cannula at least partially penetrate into the interior of the first sample tube; ii) applying the second sample tube to the transfer device, such that the at least one second cannula tip of the first cannula at least partially penetrates into the interior of the second sample tube, wherein the first cannula tip and the second cannula tip are in direct fluidic connection with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube; and iii) transferring the at least one volume of the cell suspension from the first sample tube to the second sample tube.

[0075] Embodiment 23 : The method according to the preceding embodiment, wherein the transferred volume of whole blood is a homogenous aliquot of an initial sample of whole blood in the first sample tube.

[0076] Embodiment 24: The method according to any one of the preceding method embodiments, wherein step iii) comprises a direct transfer of the volume of whole blood from the first sample tube to the second sample tube, specifically without any intermediate sample preparation step, more specifically without centrifugation.

[0077] Embodiment 25: The method according to any one of the preceding method embodiments, wherein the transfer of the volume of the whole blood comprises a homogenous transfer, specifically without altering or modifying a composition of the transferred volume of whole blood.

[0078] Embodiment 26: The method according to any one of the preceding method embodiments, wherein the method comprises, specifically prior to step i), providing the first sample tube and the second sample tube.

[0079] Embodiment 27: The method according to the preceding embodiment, wherein the first sample tube and the second sample tube are provided with a pressure difference, and / or wherein the method comprises generating a pressure difference between the first sample tube and the second sample tube using the pressure applicator connected to the pressure port. Embodiment 28: The method according to the preceding embodiment, wherein the first sample tube and the second sample tube are provided with a predetermined pressure difference to transfer a predetermined amount of an initial sample of whole blood from the first sample tube to the second sample tube.

[0080] Embodiment 29: The method according to any one of the two preceding embodiments, wherein a pressure in the first sample tube exceeds a pressure in the second sample tube.

[0081] Embodiment 30: The method according to any one of the three preceding embodiment, wherein the first sample tube is provided with ambient pressure, wherein the second sample tube is provided with vacuum, specifically with a pressure difference of at least 100 Pa, specifically of at least 1 kPa, more specifically of at least 10 kPa, most specifically of at least 15 kPa, compared to the first sample tube.

[0082] Embodiment 31 : The method according to any one of the preceding method embodiments, wherein the transfer device further comprises at least one pressure applicator configured for adjusting a pressure in the first sample tube via the pressure port of the second cannula, wherein the method comprises, specifically in step iii), adjusting the pressure in the first sample tube using the pressure applicator.

[0083] Embodiment 32: The method according to the preceding embodiment, further comprising, specifically in step iii), compensating a pressure decrease due to the transfer of the at least one volume of the cell suspension from the first sample tube to the second sample tube using the pressure applicator.

[0084] Embodiment 33: The method according to any one of the two preceding embodiments, wherein step iii) comprises pressurizing the first sample tube using the pressure applicator.

[0085] Embodiment 34: The method according to any one of the three preceding embodiments, wherein the pressure in the first sample tube is adjusted via the pressure port of the second cannula such that at least one predetermined volume of the cell suspension is transferred from the first sample tube to the second sample tube.

[0086] Embodiment 35: A use of the transfer device (110) according to any one of the preceding embodiments referring to a transfer device (110) for transferring whole blood from a first sample tube (112) to a second sample tube (114). Short description of the Figures

[0087] Further optional features and embodiments will be disclosed in more detail in the subsequent description of embodiments, preferably in conjunction with the dependent claims. Therein, the respective optional features may be realized in an isolated fashion as well as in any arbitrary feasible combination, as the skilled person will realize. The scope of the invention is not restricted by the preferred embodiments. The embodiments are schematically depicted in the Figures. Therein, identical reference numbers in these Figures refer to identical or functionally comparable elements.

[0088] In the Figures:

[0089] Figures lA to ID show an embodiment of a transfer device in different views;

[0090] Figure 2 shows a flow chart of a transfer method;

[0091] Figures 3A and 3B show another embodiment of a transfer device in a side view (Figure 3 A) and in a sectional view (Figure 3B); and

[0092] Figures 4 A and 4B show another embodiment of a transfer device in a side view (Figure 4A) and in a sectional view (Figure 4B).

[0093] Detailed description of the embodiments

[0094] Figures lAto ID show an exemplary embodiment of a transfer device 110 in different views. Specifically, Figure 1 A shows the transfer device 110 applied to a first sample tube 112 and a second sample tube 114 in a sectional view along line A- A as shown in the side view of the transfer device 110 of Figure IB. Further, Figures 1C shows a detailed sectional view of the transfer device 110 along line A- A as shown in the detailed side view of the transfer device 110 of Figure ID. In the following, Figures 1 A to ID are described in conjunction.

[0095] The transfer device 110 is configured for transferring at least one volume of a cell suspension (not shown in the Figures), specifically whole blood, from the first sample tube 112 to the second sample tube 114.

[0096] The transfer device 110 comprises at least one first cannula 116 configured for transferring the at least one volume of the cell suspension from the first sample tube 112 to the second sample tube 114. The first cannula 116 comprises at least one first cannula tip 118 configured for at least partially penetrating into an interior 120 of the first sample tube 112. The first cannula 116 further comprises at least one second cannula tip 122 configured for at least partially penetrating into an interior 124 of the second sample tube 114. The first cannula tip 118 and the second cannula tip 122 are in direct fluidic connection 126 with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube 112 to the second sample tube 114.

[0097] In the exemplary embodiment of the transfer device 110 of Figures 1A to ID, the first cannula tip 118 and the second cannula tip 122 each may comprise at least one cannula 128, each cannula 128 having at least one beveled end. Thus, as shown in Figures 1A and 1C, each of the first cannula tip 118 and the second cannula tip 122 may be embodied by a single cannula having one beveled end being in direct fluidic connection 126 with each other. However, alternatively, the first cannula tip 118 and the second cannula tip 122 may also comprise two beveled ends of a single cannula.

[0098] Further, as can be seen in the sectional views of Figures 1A and 1C, the direct fluidic connection 126 may specifically be free of any filtering or selective transfer means. The direct fluidic connection 126 of the first cannula tip 118 and the second cannula tip 122 may be configured for permitting transfer of cells, specifically cellular blood components, comprised by the cell suspension, specifically by whole blood. Alternatively or additionally, the direct fluidic connection 126 of the first cannula tip 118 and the second cannula tip 122 may be configured for avoiding altering a composition of the transferred volume of the cell suspension, specifically with respect to cells comprised by the cell suspension. For example, whole blood may be transferred by the direct fluidic connection 126 of the first cannula tip 118 and the second cannula tip 122 from the first sample tube 112 to the second sample tube 114. The direct fluidic connection 126 may specifically avoid coagulation of the transferred whole blood.

[0099] The transfer device 110 comprises at least one second cannula 130 configured for providing at least one pressure port 132 to the interior 120 of the first sample tube 112. The pressure port 132 is connectable to at least one pressure applicator 134. The pressure port 132 comprises at least one connecting element (not shown in Figure 1A) configured for connecting to the at least one pressure applicator 134. As shown in Figure 1 A, the transfer device 110 may further comprise the at least one pressure applicator 134 configured for adjusting a pressure in the first sample tube 112 via the pressure port 132 of the second cannula 130. Specifically, as indicated by arrow 136 in Figure 1A, the pressure applicator 134 may specifically be configured for engaging with the pressure port 132 of the second cannula 130. The pressure applicator 134 may further be configured for introducing gas, e.g. air from an ambient environment, via the pressure port 132 of the second cannula 130 into the first sample tube 112, specifically to the interior 120 of the first sample tube 112. For example, the pressure applicator 134 may be or may comprise at least one rubber bulb 138. Other examples are, however, also feasible.

[0100] The transfer device 110 may further comprise at least one retention vessel 139 configured for preventing leakage from the second cannula 130, specifically at least one retention vessel

[0101] 139 in fluid connection with the second cannula 130 preventing leaking of the cell suspension from the second cannula 130. The retention vessel 139 may be or may comprise a vessel or container receiving the cell suspension spilled through the second cannula 130. The retention vessel 139 may be in connection the second cannula 130, specifically with the pressure port 132 of the second cannula 130. Specifically, in the example of Figure 1A, the retention vessel 139 may coincide with the pressure port 130. However, other alternatives, such as a retention vessel 139 separate from the pressure port 132 may also be feasible. The retention vessel 139 may specifically avoid spilling of the cell suspension when using the transfer device 110.

[0102] As can be seen best in Figures IB to ID, the transfer device 110 may further comprise at least one seal cover 140, specifically a stopper and / or a cap, configured for sealing an opening of the first sample tube 112. As shown therein, the seal cover 140 may be configured for engaging with the first sample tube 112. The seal cover 140 may specifically be configured for being applied on the first sample tube 112, such as on top of an opening of the first sample tube 112, specifically irrespective of having a cap on the first sample tube 112. In this exemplary embodiment, as shown in Figures 1 A and 1C, the first cannula 116 may protrude through the seal cover 140. The first cannula tip 118 may be arranged on a first side of the seal cover 140 facing the interior 120 of the first sample tube 112. The second cannula tip 122 may be arranged on a second side of the seal cover 140 opposite to the first side. Thus, the second cannula tip 122 may be arranged on the second side of the seal cover

[0103] 140 facing the interior 124 of the second sample tube 114.

[0104] As shown in Figures 1C and ID, the second cannula tip 122 may be at least partially covered with at least one polymer sleeve 142, specifically at least one rubber sleeve. Figures 1C and ID show the transfer device 110 before being applied to the second sample tube 114. The polymer sleeve 142 may be configured for sealing the covered second cannula tip 122, specifically for preventing leakage of the cell suspension. The polymer sleeve 142 may specifically be or may comprise at least one rubber coating. The polymer sleeve 142 may prevent the cell suspension, specifically the whole blood, from escaping of the covered cannula. The polymer sleeve 142 may ensure cleanness and sterility of the covered cannula, specifically in the state shown in Figures 1C and ID before applying the transfer device 110 to the second sample tube 114. Applying the second sample tube 114 to the transfer device 110, as shown in Figure 1A and IB, may cause the polymer sleeve 142 to displace and to expose the second cannula tip 122 (denoted by reference number 144).

[0105] Further, as can be seen best in Figures IB and ID, the transfer device 110 may comprise at least one tube sleeve 146 configured for at least partially surrounding the first sample tube 112. The tube sleeve 146 may specifically ensure correct positioning of the transfer device 110 with respect to the first sample tube 112.

[0106] Figure 2 shows a flow chart of an exemplary embodiment of a transfer method for transferring at least one volume of a cell suspension, specifically whole blood, from a first sample tube 112 to a second sample tube 114. The transfer method may specifically comprise using a transfer device 110 according to the present invention, such as according to the exemplary embodiment shown in Figures 1A to ID and / or according to any other embodiment disclosed herein. Thus, for a detailed description of the transfer device 110, reference is made to the description of Figures 1 A to ID.

[0107] The transfer method comprises the following method steps, which specifically may be performed in the given order. However, a different order may also be possible. It may further be possible to perform one, more than one or even all of the method steps repeatedly. Further, it may be possible to perform two or more of the method steps in a fashion overlapping in time and / or fully or partially simultaneously.

[0108] The method comprises: i) (denoted by reference number 148) applying the at least one transfer device 110 according to the present invention to the first sample tube 112 comprising the cell suspension, such that the at least one first cannula tip 118 of the first cannula 116 and the second cannula 130 at least partially penetrate into the interior 120 of the first sample tube 112; ii) (denoted by reference number 150) applying the second sample tube 114 to the transfer device 110, such that the at least one second cannula tip 122 of the first cannula 116 at least partially penetrates into the interior 124 of the second sample tube 114, wherein the first cannula tip 118 and the second cannula tip 122 are in direct fluidic connection 126 with each other, enabling a transfer of the at least one volume of the cell suspension from the first sample tube 112 to the second sample tube 114; and iii) (denoted by reference number 152) transferring the at least one volume of the cell suspension from the first sample tube 112 to the second sample tube 114. The method may further comprise, specifically prior to step i), providing the first sample tube 112 and the second sample tube 114. The first sample tube 112 may specifically be provided with the cell suspension, specifically whole blood, comprised in the interior 120 of the first sample tube 112. The first sample tube 112 and the second sample tube 114 may be provided with a pressure difference. The first sample tube 112 may be provided with ambient pressure. The second sample tube 114 may be provided with vacuum. Specifically, the second sample tube may be provided with a pressure difference of at least 100 Pa, specifically of at least 1 kPa, more specifically of at least 10 kPa, most specifically of at least 15 kPa, compared to the first sample tube, specifically a negative pressure difference compared to the first sample tube. In other words, the pressure of the second sample tube may be lower than the pressure of the first sample tube. For example, the first sample tube may be at atmospheric pressure. For example, for sample tubes of a volume of 10 ml, the second sample tube may have a negative pressure difference of 75 mmHg, which is approximately 10 kPa, compared to the first sample tube. For example, for sample tubes of a volume of 5 ml, the second sample tube may have a negative pressure difference of 50 mmHg, which is approximately 6.6 kPa, compared to the first sample tube.

[0109] As outlined above, the transfer device 110 may comprises the at least one pressure applicator 134 configured for adjusting a pressure in the first sample tube 112 via the pressure port 132 of the second cannula 130. The method may comprise, specifically in step iii), adjusting the pressure in the first sample tube 112 using the pressure applicator 134. For example, the method may comprise, specifically in step iii), compensating a pressure decrease due to the transfer of the at least one volume of the cell suspension from the first sample tube 112 to the second sample tube 114 using the pressure applicator 134. Alternatively or additionally, step iii) may comprise pressurizing the first sample tube 112 using the pressure applicator 134. The pressurizing may specifically comprise increasing a pressure in the first sample tube 112, e.g. such that the at least one volume of the cell suspension is transferred form the first sample tube 112 to the second sample tube 114. Alternatively or additionally, the pressure in the first sample tube 112 may be adjusted via the pressure port 132 of the second cannula 130 such that at least one predetermined volume of the cell suspension is transferred from the first sample tube 112 to the second sample tube 114.

[0110] Figures 3 A and 3B show another exemplary embodiment of a transfer device 110. Figure 3 A shows the transfer device 110 in a side view and Figure 3B shows the transfer device 110 in a sectional view along the line A- A indicated in Figure 3 A. The embodiments of the transfer device 110 shown in Figures 3 A and 3B widely corresponds to the exemplary embodiment of the transfer device 110 shown in Figures 1A to ID. Thus, for a detailed description of the transfer device 110, reference is made to the description of Figures 1 A to ID.

[0111] In this exemplary embodiment, as shown in Figure 3B, the first cannula 116, specifically the first cannula tip 118, and the second cannula 130 may extend essentially parallel into the interior 120 of the first sample tube 112. A distance between the first cannula 116, specifically the first cannula tip 118, and the second cannula 130 may be at least one times of a diameter of at least one of the first cannula 116 and the second cannula 130, specifically at least two times of a diameter of at least one of the first cannula 116 and the second cannula 130. The diameter may specifically one of an inner diameter and an outer diameter of the respective cannula. In case the first cannula 116 and the second cannula 130 have different diameter, the distance may specifically be based on the diameter of the larger cannula. The distance between the first cannula 116 and the second cannula 130 may ensure that the pierced septum or sealing element of the first 112 and / or second sample tube 114 is tightly sealed after removal of the transfer device 110 from the respective sample tube. Further, the distance between the first cannula 116 and the second cannula 130 may enable a transfer of the volume from the first sample tube 112 to the second sample tube 114 even if the sample tubes 112, 114 are not held vertically, in particular even if the sample tubes 112, 114 are held horizontally, during transfer of the volume.

[0112] Further, as can be seen in Figure 3B, the pressure port 132 comprises the at least one connecting element 154. The connecting element 154, in this example, may comprise a pipe connecting element 156. Thus, the connecting element 154 may be configured for connecting to the pressure applicator 134, such as to the rubber bulb 138.

[0113] Figures 4A and 4B show another exemplary embodiment of a transfer device 110. Figure 4A shows the transfer device 110 in a perspective view and Figure 4B shows the transfer device 110 in a sectional view along the line A-A as indicated in Figure 4A. The embodiments of the transfer device 110 shown in Figures 4A and 4B widely corresponds to the exemplary embodiment of the transfer device 110 shown in Figures 3A and 3B. Thus, for a detailed description of the transfer device 110, reference is made to the description of Figures 3 A and 3B. However, in this exemplary embodiment, the connecting element 154 may comprise a luer lock connecting element 158. Thus, the connecting element 154 may be configured for connecting to the pressure applicator 134, such as to a syringe (not shown in the Figures). List of reference numbers transfer device first sample tube second sample tube first cannula first cannula tip interior of first sample tube second cannula tip interior of the second sample tube direct fluidic connection cannula second cannula pressure port pressure applicator arrow rubber bulb retention vessel seal cover polymer sleeve displaced polymer sleeve tube sleeve applying the transfer device to the first sample tube applying the second sample tube to the transfer device transferring the at least one volume of the cell suspension connecting element pipe connecting element luer lock connecting element

Claims

Claims1. A transfer device (110) for transferring at least one volume of whole blood from a first sample tube (112) to a second sample tube (114), the transfer device (110) comprising: at least one first cannula (116) configured for transferring the at least one volume of whole blood from the first sample tube (112) to the second sample tube (114), wherein the first cannula (116) comprises at least one first cannula tip (118) configured for at least partially penetrating into an interior (120) of the first sample tube (112), wherein the first cannula (116) further comprises at least one second cannula tip (122) configured for at least partially penetrating into an interior (124) of the second sample tube (114), wherein the first cannula tip (118) and the second cannula tip (122) are in direct fluidic connection (126) with each other, enabling a transfer of the at least one volume of whole blood from the first sample tube (112) to the second sample tube (114); and at least one second cannula (130) configured for providing at least one pressure port (132) to the interior (120) of the first sample tube (112), wherein the pressure port (132) is connectable to at least one pressure applicator (134), wherein the pressure port (132) comprises at least one connecting element (154) configured for connecting to the at least one pressure applicator (134).

2. The transfer device (110) according to the preceding claim, wherein the connecting element (154) comprises at least one element selected from the group consisting of: a pipe connecting element (156); a luer lock connecting element (158); other thread supported connections.

3. The transfer device (110) according to any one of the preceding claims, wherein a length of a penetrating part of the second cannula (130) penetrating the interior (120) of the first sample tube (112) exceeds a length of a penetrating part of the first cannula tip (118) penetrating into the interior (120) of first sample tube (112).

4. The transfer device (110) according to any one of the preceding claims, wherein the first cannula (116), specifically the first cannula tip (118), and the second cannula (130) extend essentially parallel into the interior (120) of the first sample tube (112),wherein a distance between the first cannula (116), specifically the first cannula tip (118), and the second cannula (130) is at least one times of a diameter of at least one of the first cannula (116) and the second cannula (130), specifically at least two times of a diameter of at least one of the first cannula (116) and the second cannula (130).

5. The transfer device according to any one of the preceding claims, wherein the pressure port (132) of the second cannula (130) is a stationary pressure port.

6. The transfer device (110) according to any one of the preceding claims, wherein the direct fluidic connection (126) of the first cannula tip (118) and the second cannula tip (122) is configured for permitting transfer of cells comprised by whole blood.

7. The transfer device (110) according to any one of the preceding claims, wherein the direct fluidic connection (126) of the first cannula tip (118) and the second cannula tip (122) is configured for avoiding altering a composition of the transferred volume of whole blood.

8. The transfer device (110) according to any one of the preceding claims, further comprising at least one pressure applicator (134) configured for adjusting a pressure in the first sample tube (112) via the pressure port (132) of the second cannula (130).

9. The transfer device (110) according to any one of the preceding claims, wherein at least one of the first cannula (116) and the second cannula (130) is at least partially covered with at least one polymer sleeve (142), the polymer sleeve (142) being configured for sealing the covered cannula.

10. The transfer device (110) according to any one of the preceding claims, wherein at least one of the first cannula (116) and the second cannula (130) is covered by at least one protective cover, the protective cover being configured for providing puncture protection.

11. The transfer device (110) according to any one of the preceding claims, further comprising at least one seal cover (140) configured for sealing an opening of the first sample tube (112), wherein the first cannula (116) protrudes through the seal cover (140).

12. The transfer device (110) according to the preceding claim, wherein the first cannula tip (118) is arranged on a first side of the seal cover (140) facing the interior (120) ofthe first sample tube (112), wherein the second cannula tip (122) is arranged on a second side of the seal cover (140) opposite to the first side.

13. The transfer device (110) according to any one of the two preceding claims, wherein the second cannula tip (122) is arranged on a second side of the seal cover (140) facing the interior (124) of the second sample tube (114).

14. The transfer device (110) according to any one of the preceding claims, wherein the first cannula tip (118) and the second cannula tip (122) each comprise at least one cannula (128).

15. The transfer device (110) according to any one of the preceding claims, further comprising at least one tube sleeve (146) configured for at least partially surrounding the first sample tube (112).

16. The transfer device (110) according to any one of the preceding claims, further comprising at least one retention vessel (139) configured for preventing leakage from the second cannula (130).

17. A transfer method for transferring at least one volume of whole blood from a first sample tube (112) to a second sample tube (114), the method comprising: i) applying at least one transfer device (110) according to any one of the preceding claims to the first sample tube (112) comprising the cell suspension, such that the at least one first cannula tip (118) of the first cannula (116) and the second cannula (130) at least partially penetrate into the interior (120) of the first sample tube (112); ii) applying the second sample tube (114) to the transfer device (110), such that the at least one second cannula tip (122) of the first cannula (116) at least partially penetrates into the interior (124) of the second sample tube (114), wherein the first cannula tip (118) and the second cannula tip (122) are in direct fluidic connection (126) with each other, enabling a transfer of the at least one volume of whole blood from the first sample tube (112) to the second sample tube (114); and iii) transferring the at least one volume of whole blood from the first sample tube (112) to the second sample tube (114).

18. The method according to the preceding claim, wherein the transferred volume of whole blood is a homogenous aliquot of an initial sample of whole blood in the first sample tube (112).

19. The method according to any one of the preceding method claims, wherein step iii) comprises a direct transfer of the volume of whole blood from the first sample tube (112) to the second sample tube (114), specifically without any intermediate sample preparation step, more specifically without centrifugation.

20. The method according to any one of the preceding method claims, wherein the transfer of the volume of the whole blood comprises a homogenous transfer, specifically without altering a composition of the transferred volume of whole blood.

21. The method according to any one of the preceding method claims, wherein the method comprises providing the first sample tube (112) and the second sample tube (114), wherein the first sample tube (112) and the second sample tube (114) are provided with a pressure difference and / or wherein the method comprises generating a pressure difference between the first sample tube (112) and the second sample tube (114) using the pressure applicator (134) connected to the pressure port (132).

22. The method according to the preceding claim, wherein the first sample tube (112) and the second sample tube (114) are provided with a predetermined pressure difference to transfer a predetermined amount of an initial sample of whole blood from the first sample tube (112) to the second sample tube (114).

23. The method according to any one of the two preceding claims, wherein a pressure in the first sample tube (112) exceeds a pressure in the second sample tube (114).

24. The method according to any one of the preceding method claims, wherein the transfer device (110) further comprises at least one pressure applicator (134) configured for adjusting a pressure in the first sample tube (112) via the pressure port (132) of the second cannula (130), wherein the method comprises adjusting the pressure in the first sample tube (112) using the pressure applicator (134), wherein the pressure in the first sample tube (112) is adjusted via the pressure port (132) of the second cannula (130) such that at least one predetermined volume of the whole blood is transferred from the first sample tube (112) to the second sample tube (114).

25. A use of the transfer device (110) according to any one of the preceding claims referring to a transfer device (110) for transferring whole blood from a first sample tube (112) to a second sample tube (114).

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