Sampling device for sampling bodily fluid

Abstract

A sampling device (110) for sampling bodily fluid is proposed, comprising a stationary component (118) and a movable component (120) being movably mounted to the stationary component (118). The movable component (120) is movable from at least one distal position to at least one proximal position and back. The movable component (120) comprises at least one penetration element (132) for penetrating the skin of a user, which, in the distal position of the movable component (120), is received within the stationary component (118) and which, in the proximal position of the movable component (120), protrudes from an application side (128) of the stationary component (118). The movable component (120) comprises a container receptacle (134) for receiving at least one sample container (114) having a septum (136). The sampling device (110) further comprises a sample collection channel (138) for transporting sample from the application side (128) into the container receptacle (134). The sampling device (110) further comprises a pressure chamber (140) having a volume being dependent on the position of the movable component (120), wherein the volume when the movable component (120) is in the proximal position is smaller than the volume when the movable component (120) is in the distal position. The sampling device (110) further comprises a pressure adjustment channel (154) for transferring underpressure from the pressure chamber (140) into the sample container (114) through the septum (136) when the movable component (120) is retracted from the proximal position into the distal position. Further, a sampling kit (112) for sampling bodily fluid and a method for generating an underpressure in a sample container (114) having a septum (136) are proposed.

Description

[0001] Sampling device for sampling bodily fluid

[0002] Technical Field

[0003] The invention relates to a sampling device for sampling bodily fluid and to a sampling kit comprising the sampling device, and to a method for generating an underpressure in a sample container having a septum. The devices and the method according to the invention specifically may be used in the field of diagnostic sampling, both in homecare and in a professional medical environment. Specifically, the devices and the method may be used for sampling of capillary blood. Other applications of the present invention are also feasible.

[0004] Background art

[0005] Both in the field of home care and in professional medical environments such as hospitals or nursing homes, means and methods for penetrating the skin of a user are widely used. In the following, the invention specifically will be described in the context of sampling of capillary blood. It shall be noted, however, that other applications are also feasible.

[0006] For penetrating the skin of the user, besides traditional manual means using manually-handled lancets or needles, automatic devices are known and becoming more and more popular. Specifically, means and methods for diagnostic sampling of capillary blood are applied e.g. in the field of self-sampling or home sampling. These means and methods require a penetration of the skin and, specifically, a punctuation of capillary blood vessels. Subsequently, samples of blood, such as droplets of capillary blood, are collected by using appropriate collection means, such as paper, plasma separation cards or sample tubes. The samples may then be analyzed, either at home or by shipping these samples to analytical facilities. Home sampling, meanwhile, is widely used, specifically for avoiding frequent visits to the doctor or to the hospital. The penetration of the own skin for self-sampling typically takes some effort for the user. Automatic devices avoiding the necessity of manually pricking e.g. the fingertip with a needle or a lancet are rather helpful for overcoming these efforts. Devices for punctuating the skin are commercially available, such as by Tasso, Inc., Seattle, WA 98119, USA, or by YourBio Health, Inc., Medford, MA 02155, USA. The triggering of these sampling devices may either take place by a pushbutton to be actively pushed by the user or by pressing the device onto the skin, whereby the device is triggered and a needle or lancet, driven by a spring, penetrates the skin.

[0007] US 2017 / 0172481 Al describes apparatus, systems and methods, which relate to devices, systems and methods for the collection of bodily fluids involving a single-use actuation and retraction mechanism disposed within a collector.

[0008] One technical challenge, however, which typically arises in these devices for blood sampling, resides in the safety and the convenience of collecting the samples of the bodily fluid. Thus, in typical devices, sample containers, such as sample tubes or other types of sample vessels, are handled manually and in an open state. Handling open sample containers, however, may lead to a spilling of sample from the container, which may result in a contamination of surrounding environment and / or the personal belongings of the user and / or may lead to a loss of sample. Further, the risk of infections is given.

[0009] A further technical challenge arises from the difficulties in collecting the sample in the sample container. Typically, at least for larger amounts of samples, capillary blood flows into the sample container driven by gravitational force. Consequently, the sampling device and the sample container have to be located and oriented such that the sample container is below the site of incision, so the sample can flow into the container driven by its own gravity.

[0010] Further, many means and methods for collecting samples of bodily fluid are not compatible with standardized analytical devices or laboratory analytics. Consequently, samples of bodily fluid, before analysis, have to be transferred into standardized sampling devices usable for laboratory analytics. In addition, standardized sample containers for blood sampling often contain anticoagulants. In the special sample containers used for home sampling, however, the commercial availability of containers containing anticoagulants is limited.

[0011] Consequently, there is a need for sampling devices addressing the above-mentioned technical challenges. Specifically, the sampling shall take place with minimum loss of sample and by avoiding contaminations of the surroundings and of the personal belongings of the user. The process of sampling and, specifically, also the subsequent process of shipping the sample to the doctor, the hospital or an analytical facility shall be convenient, simple and secure.

[0012] Problem to be solved

[0013] It is therefore desirable to provide a sampling device, a sampling kit and a corresponding method, which at least partially address the above-mentioned technical challenges of known devices and methods. The devices and method specifically should be applicable in the field of blood sampling. The devices and method specifically should provide a high reliability and convenience for sampling, a low loss of sample and a low risk of spilling sample. Further, compatibility with standardized laboratory analysis systems is desirable.

[0014] Summary

[0015] This problem is addressed by a sampling device, by a sampling kit and by a method for generating an underpressure in a sample container having a septum, 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.

[0016] 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.

[0017] 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.

[0018] 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.

[0019] In a first aspect of the present invention, a sampling device for sampling bodily fluid is proposed. The sampling device comprises at least one stationary component and at least one movable component being mounted to the stationary component in a movable manner relative to the stationary component. The movable component is movable from at least one distal position to at least one proximal position and back. The stationary component has an application side. The movable component comprises at least one penetration element configured for penetrating the skin of a user. The penetration element, in the distal position of the movable component, is received within the stationary component. In the proximal position of the movable component, the penetration element protrudes from the application side of the stationary component. The movable component comprises a container receptacle for receiving at least one sample container, the sample container having a septum. The sampling device further comprises at least one sample collection channel arranged for transporting sample from the application side, specifically from the skin of the user, into the container receptacle, specifically into the sample container through the septum. The sampling device further comprises a pressure chamber having a volume being dependent on the position of the movable component. The volume of the pressure chamber when the movable component is in the proximal position is smaller than the volume of the pressure chamber when the movable component is in the distal position. The sampling device further comprises at least one pressure adjustment channel configured for transferring underpressure from the pressure chamber into the sample container through the septum when the movable component is retracted from the proximal position into the distal position. The term “sampling 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 an arbitrary device, specifically a medical device, which is configured for collecting a sample, specifically a liquid sample, more specifically a sample of the bodily fluid. Thus, specifically, the sampling device may be configured for actively transporting the sample, from a sampling site, e.g. a sampling side on the application side of the device, more specifically a sampling side on the skin of the user, more specifically a sampling side having an incision created by the penetration element, into a sample container. The sampling device specifically, as will be outlined in further detail below, may be configured for sucking the sample into the sample container. The sampling device specifically may be a handheld device having a volume of less than 1.000 ccm and / or a weight of less than 200 g.

[0020] The term “bodily fluid” 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 fluid generated by the body of a living being, specifically of a human being. Thus, generally, the bodily fluid may be selected from the group consisting of blood, interstitial fluid, lacrimal fluid, urine and saliva. More specifically, the bodily fluid may be blood, more specifically a capillary blood.

[0021] The term “stationary component”, 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 component of a device, the component having one or more elements, the component being, in the intended use, widely stationary with respect to a chosen inertial system or coordinate system, such as the coordinate system of at least one of a coordinate system of the user’s hand holding the transdermal medical device, a coordinate system of the sampling device itself, a coordinate system of the body surface of the user. The term “stationary component” specifically may also be used to distinguish said component from one or more movable parts, such as the movable component described in further detail below.

[0022] Similarly, the term “movable component”, 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 component of a device, the component having one or more elements, the compo- nent being, in the intended use, movable within a chosen inertial system or coordinate system, such as the coordinate system of at least one of: a coordinate system of the user’s hand holding the sampling device, a coordinate system of the sampling medical device itself, a coordinate system of the body surface of the user. The term “movable component” specifically may also be used to distinguish said component from one or more stationary parts, such as the movable component described above. Consequently, the terms “stationary component” and “movable component” specifically may be used as mere nomenclature, indicating that the stationary component may define a coordinate system in which the movable component is movable, in one or more linear movements and / or in one or more nonlinear movements and / or in one or more rotational movements.

[0023] The movable component may comprise a plurality of elements, wherein each of the elements may be movable e.g. relative to the stationary component. As an example, the movable component may comprise the following elements, whose function and interrelation may be discussed in further detail below: at least one movable body; at least one upper movable component; at least one container adapter, which may comprise at least one grip and / or at least one lower abutment; at least one piston; at least one penetration element carrier, which may comprise at least one sealing element; at least one penetration element. The movable component may comprise further elements, which are not listed here.

[0024] The plurality of elements forming the movable component may be movable together. In particular, the elements of the movable component may be linked and / or connected to each other in such a way that the elements forming the movable component may move together, specifically simultaneously, when the movable component is moved from the distal position to the proximal position. Additionally or alternatively, the elements of the movable component may move at least partially in a sequential manner, when the movable component is moved from the distal position to the proximal position. Thus, as an example, at least one first subset of elements and at least one second subset of elements may move in a staggered fashion such that their movements are not entirely simultaneous, but are either separated in time or overlap only partially in time. In particular, the movement of the first subset of elements may trigger the staggered movement of the second subset of elements. As an example, the first subset of elements comprising e.g. the movable body and the upper movable component may move initially, while at least one second subset of elements comprising the penetration element carrier and the penetration element may move in a delayed or staggered fashion e.g. when the first subset has reached or almost reached the proximal position. As outlined above, the movable component is mounted to the stationary component in a movable manner, such that the movable component is movable from at least one distal position to at least one proximal position and back. Thus, the movement is a reversible movement, even though the movement may be divided into movement sections or movement periods which not necessarily are performed without intermission. Specifically, the movement may be a linear movement. Other movements, however, are also feasible. The stationary component may also provide for one or more guiding elements, such as one or more guiding surfaces, configured for guiding the movement of the movable component from the distal position to the proximal position. The movement specifically, as will be outlined in further detail below, may also be a reversible movement, such that the movable component may move back, from the proximal position, to the distal position. Therein, the direction of movement from the distal position to the proximal position may define a penetration direction, wherein the opposite direction of movement, i.e. the movement from the proximal position to the distal position, may define a retraction direction of the movable component.

[0025] The terms “distal position” and “proximal position”, as used herein, are broad terms and are to be given their ordinary and customary meaning to a person of ordinary skill in the art and are not to be limited to a special or customized meaning. The terms specifically may be used as mere nomenclature to distinguish the positions of the movable component. The terms specifically, however, may be used in the context of the intended use of the sampling device. Thus, in the intended use, the distal position may be at least one position of the movable component in which the movable component is located away from the skin of the user, whereas the proximal position may be a position of the movable component in which the movable component is located closest to the skin of the user. Specifically, the proximal position may be a position in which the penetration element may penetrate the skin of the user. Therein, one or more than one proximal position and / or one or more than one distal position may be present. As an example, before use, the movable component may be in a first distal position, and after use, the movable component may be in a second distal position, which may be or may not be identical to the first distal position.

[0026] The term “application side”, 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 side of the stationary component which, in the intended use, faces the body surface of the user. The application side specifically may comprise at least one application surface which may directly or indirectly be applied to the body surface of the user. Thus, the application surface may directly rest on the body surface, or the application surface may rest on at least one intermediate component interposed in between the body surface and the stationary component. The application surface on the application side specifically may be or may comprise a ring-shaped surface. The ring-shaped surface, as an example, may surround a recess in the application surface, the recess, as an example, being crossed by the penetration element during the penetration process, wherein, in the recess, bodily fluid may be present during or after penetration. As will be outlined in further detail below, from the recess, bodily fluid may be transferred through the sample collection channel and may be transported into the container receptacle, specifically into the sample container through the septum, the sample container being received in the container receptacle. The application side, specifically the application surface on the application side, specifically may be a part of the stationary component from which, during penetration, the penetration element protrudes.

[0027] The sampling device, on the application side, may further comprise at least one sealing element and / or protection element. Thus, as an example, a sterile seal may be provided. As an example, the application side may fully or partially be covered with at least one protective liner which may be removed by the user before use of the sampling device, specifically before applying the sampling device to the body surface.

[0028] The term “penetration element”, as used herein, also often referred to as a “needle” or a “lancet”, 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 element configured for penetrating the skin and optionally also the body tissue of the user. For this purpose, the penetration element specifically may comprise at least one of a sharp, a tip, and a point. More specifically, the penetration element may comprise at least one of a needle or a lancet. The penetration element may have an elongated shape, with the sharp or point being located at a proximal end of the penetration element. The penetration element may be sterile. Specifically, the penetration element may be provided in a sterile state. The penetration element may fully or partially be made of a solid material or element or may also be made as a hollow or slotted element. The penetration element, as an example, may be made of at least one of a metallic material and a plastic material. Other materials, however, are also feasible.

[0029] The movable component may comprise one or more components. Specifically, the movable component may comprise a movable body, such as a movable body made as a solid cylinder, a block, a plunger or the like, with the at least one penetration element directly or indirectly mounted thereto, such as with the penetration element protruding, on a side facing the application side, from the movable body. As an example, the movable body may be made of a plastic material, whereas the penetration element, as outlined above, may be made e.g. of a metallic material. The movable body of the movable component specifically may be made by molding techniques, such as injection molding, and the penetration element may be integrated therein or mounted thereto e.g. by material connection, such as by insert molding. Other techniques, however, are also feasible. Additionally or alternatively, the at least one penetration element may also be mounted to at least one separate component being part of the movable component, such as to at least one penetration element carrier. The penetration element carrier may be in contact with the movable body of the movable component, such as with at least one piston of the movable component. The penetration element carrier, as will be outlined in further detail below, specifically may comprise at least one sealing element. The penetration element carrier may freely move within the stationary component or, alternatively, may be attached to one or more other components of the movable component.

[0030] The sampling device may comprise one or more penetration elements. As will be outlined in further detail below, the one or more penetration elements specifically may be located in an off-centered manner with respect to a penetration axis or axis of symmetry of the sampling device. As an example and as will be shown with respect to one or more embodiments below, more than one penetration element may be provided, wherein the penetration elements are oriented essentially parallel to the penetration axis and / or may be distributed essentially symmetrical about the penetration axis. At least one orifice of the sample collection channel may be located on-axis with respect to the penetration axis, and the penetration elements may surround the orifice symmetrically.

[0031] As further outlined above, the at least one penetration element, in the distal position of the movable component, is received within the stationary component and, in the proximal position of the movable component, protrudes from the application side of the stationary component. Thus, in the distal position, the stationary component may act as a housing or as a part of the housing which fully or partially surrounds the penetration element and possibly further parts of the movable component, such as at least a part of the above-mentioned movable body of the movable component. In the proximal position of the movable component, however, the penetration element specifically may protrude from the application side of the stationary component. Specifically, the stationary component may provide for a housing such as a sleeve in which the movable component or at least a part thereof may move, specifically slide, from the distal position to the proximal position, wherein, in the distal position, the penetration element is fully circumferentially surrounded by the sleeve formed by the stationary component and wherein, in the proximal position, the penetration element protrudes from the application side. As further outlined above, the movable component comprises a container receptacle for receiving at least one sample container having a septum. The term “container receptacle” 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 space within an element or device which is configured for receiving at least one container. Thus, as an example, the movable component may comprise one or more inner spaces configured for receiving the sample container, specifically in a removable fashion. The one or more inner spaces may fully or partially be surrounded by the movable component and / or received within the movable component, such that the one or more inner spaces move with the movable component when the movable component moves from the distal position into the proximal position and / or from the proximal position into the distal position. As an example, the one or more inner spaces may comprise one or more cylindrical spaces and / or one or more cylindrical recesses fully or partially surrounded by the movable component and / or fully or partially integrated in the movable component, notwithstanding the fact that one or more parts of the stationary component may also be in contact with the sample container received within the container receptacle, e.g. in a gliding fashion.

[0032] The term “sample container” 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 container configured for receiving the sample of the bodily fluid. As an example, the sample container may be selected from the group consisting of: a sample tube, a vial, a jar. Specifically, the sample container may have a tubular shape. The sample container may be oriented in the container receptacle such that an opening of the sample container is oriented towards the application side of the sampling device. The opening specifically may be closed by the septum. The sampling device, specifically the movable component, may comprise one or more fixation elements for holding the sample container in the container receptacle. Thus, as an example, the sampling device may hold the sample container in the container receptacle by pressing the sample container against one or more abutment surfaces. Examples will be given in further detail below.

[0033] Thus, generally, the sample container may be oriented, in the container receptacle, with at least one opening facing towards the application side. The opening may fully or partially be covered by a septum. Thus, as an example, the sample container may have a cover or plug, specifically a removable cover, having a septum which may be pierced by a needle or the like. The term “septum” 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 wall of a container or element delimiting a container which may be pierced by a piercing element as defined above, such as by a needle. More specifically, the septum may be a flexible wall or a flexible cover of a container, specifically a planar part of a flexible cover, which is made of at least one flexible material providing sealing properties against leaking of liquids and / or gases and which, on the other hand, may be penetrated by at least one piercing element. As an example, the septum may fully or partially be made of at least one elastomeric material. Thus, the sample container may fully or partially be made of a rigid material, such as glass and / or a rigid plastic material such as a thermoplastic material, whereas the septum fully or partially covering an opening of the sample container may fully or partially be made of at least one elastomeric material, specifically a flexible elastomeric material.

[0034] As outlined above, the sampling device further comprises at least one sample collection channel arranged for transporting sample from the application side, specifically from the skin of the user, into the container receptacle, specifically into the sample container through the septum. The term “sample collection channel” 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 fluid connection or lumen configured for transporting fluid from at least one first location to at least one second location. As will be outlined in further detail below, the sample collection channel specifically may be integrated into one or more sample collection elements, such as one or more cannulas, one or more tubes or the like. The sample collection channel, thus, provides for a fluid connection between a place in which the sample is generated, e.g. from a site of incision or penetration of the skin of the user, to the container receptacle. Specifically, the sample collection channel may protrude into the container receptacle, to a location in which, when a sample container is received within the container receptacle, an inner space of the sample container is located, specifically such that the sample collection channel protrudes through the septum into the inner space of the sample container.

[0035] As further outlined above, the sampling device further comprises a pressure chamber having a volume being dependent on the position of the movable component. The dependency is such that the volume of the pressure chamber, when the movable component is in the proximal position, is smaller than the volume of the pressure chamber when the movable component is in the distal position. The term “pressure chamber” 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 space, specifically a sealed space, in a device or in an element, wherein the space may be compressed and / or expanded. For this purpose, as an example, the pressure chamber specifically may be limited by at least one movable wall, such as the wall of a piston movable towards the pressure chamber and away from the pressure chamber and / or a penetration element carrier carrying the at least one penetration element. The piston, as will be outlined in further detail below, specifically may be part of the movable component. By compressing and / or expanding the volume of the pressure chamber, a pressure in the pressure chamber may be increased or decreased, respectively. For this purpose, specifically, a fixed amount of gas, specifically air, in the pressure chamber may be provided, which is either compressed or expanded, thereby increasing or decreasing the pressure of the gas, respectively. The volume of the pressure chamber, when the movable component is in the proximal position, is lower than the volume of the pressure chamber when the movable component is in the distal position. More specifically, the situation may be adjusted such that the pressure in the pressure chamber, when the movable component is in the distal position, is lower than the pressure of the ambient air, such as lower than the normal or standard pressure of 1.01325 bar, specifically at 20 °C. This is what is, herein, referred to as an “underpressure”. Consequently, as used herein, the term “underpressure”, also referred to as a “negative pressure” or “low-pressure”, 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 pressure being lower than the pressure in the ambient environment or the ambient pressure. Specifically, the term may refer to a pressure below 1.01325 bar. In other words, an atmosphere of underpressure in a first space being in liquid or fluid connection with a second space having a normal pressure or pressure of 1.01325 bar is typically such that fluid from the second space is sucked into the first space.

[0036] This effect of the pressure chamber having the variable volume is used for generating a low- pressure within the sample container received in the container receptacle of the movable component. The low-pressure in the sample container, again, may be used for sucking sample of the bodily fluid, from the application side or from the skin of the user, through the sample collection channel, into the inner space of the sample container, specifically through the septum. For this purpose, however, the low-pressure generated in the pressure chamber when the movable component is moved from the proximal position into the distal position is to be transferred into the inner space of the sample container. Therefore, as outlined above, the sampling device further comprises the at least one pressure adjustment channel configured for transferring underpressure from the pressure chamber into the sample container through the septum when the movable component is retracted from the proximal position into the distal position. The term “pressure adjustment channel” 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 channel or a lumen providing for a connection between at least one first location and at least one second location, allowing for a fluid, e.g. a gas, such as air, to flow from the first location to the second location or from the second location to the first location, in order to provide, at least partially, a pressure adjustment between the first location and the second location. Consequently, the term “transferring underpressure from the pressure chamber into the sample container” specifically may refer to the fact that a fluid, specifically a gas, more specifically air, may flow from the sample container to the pressure chamber when the movable component is moved from the proximal position into the distal position, such that the pressure in the sample container is lowered and a pressure adjustment between the pressure chamber and the inner space of the sample container at least partially is in use. Thereby, a low-pressure in the sample container is generated, which may enable the sampling device to suck bodily fluid, through the sample collection channel, into the sample container.

[0037] In particular, the pressure adjustment channel may be configured for adjusting the pressure in the sample container to the underpressure generated in the pressure chamber when the movable component is retracted from the proximal position into the distal position.

[0038] As outlined above, the sample collection channel may be embodied in various ways. The sample collection channel specifically may be integrated into one or more elements of the sampling device. Specifically, the sampling device may comprise a cannula, with a tip protruding into the container receptacle, specifically into the sample container through the septum. This cannula, also referred to as a hollow needle, may provide for the sample collection channel. Thus, the sample collection channel may fully or partially be constituted by the lumen of the cannula. As opposed to the penetration element, however, the tip of the cannula may point away from the body surface, such as into the retraction direction. The tip of the cannula may be located in the container receptacle and, thus, may protrude, through the septum, into the sample container received in the container receptacle.

[0039] The cannula specifically may be separate from the penetration element. Thus, as an example, the cannula may be mounted to or may be integrated into the stationary component, whereas the penetration element may be mounted to or integrated directly or indirectly into the movable component and / or to a penetration element carrier. The cannula may comprise at least one orifice at the application side of the stationary component. Specifically, as already mentioned above, the stationary component, on the application side, may comprise a sampling recess facing the skin of the user, with the orifice being located in the sampling recess. Thus, bodily fluid may collect in the sampling recess, e.g. in a flat front face of the stationary component, which may be applied to the body surface of the user. From this recess or sampling recess, the sample collection channel, specifically constituted by the cannula, may transfer the bodily fluid into the container receptacle, specifically through the septum into the sample container. The penetration element may also pass through the sampling recess when the movable component is moved from the distal position into the proximal position.

[0040] As outlined above, the cannula specifically may be mounted to the stationary component. The tip of the cannula may protrude into the container receptacle in all positions of the movable component, specifically into the sample container through the septum. Thus, as an example by providing appropriate stops for limiting the movement of the movable component and / or for defining the distal position and the proximal position, the tip of the cannula may be located sufficiently protruding into the container receptacle such that, during the entire movement, the tip is located within the sample container, specifically protruding through the septum of the sample container.

[0041] As outlined above, the sample collection channel and the pressure adjustment channel fulfill different purposes and, therefore, specifically are separate channels. The sample collection channel specifically is configured for fluid transfer, specifically for the transfer of a liquid sample of bodily fluid, whereas the pressure adjustment channel specifically is configured for providing an equalization of pressure, e.g. between the pressure chamber and the sample container received in the container receptacle. This is notwithstanding the fact that the sample collection channel and the pressure adjustment channel may also be integrated into one and the same element, as separate channels. Consequently, the pressure adjustment channel specifically may at least partially be integrated with the cannula. Thus, as will be shown in further detail below, even though the sample collection channel and the pressure adjustment channel are separate, the cannula may be a double-walled cannula, having at least two lumens, wherein at least one of the lumens constitutes or is part of the sample collection channel and wherein at least another one of the lumens is part of or constitutes the pressure adjustment channel. More specifically, the sample collection channel may at least partially be formed by a central lumen of the double-walled cannula, and the pressure adjustment channel may at least partially be formed by a ring-shaped space concentrically surrounding the central lumen.

[0042] Generally, however, a spillover of bodily fluid from the sample container into the pressure chamber is unwarranted and should be avoided. Therefore, a length of the sample collection channel may exceed a length of the pressure adjustment channel. Specifically, the pressure adjustment channel, at least during a part of the movement of the movable component from the proximal position into the distal position, protrudes into the container receptacle, specifically into the sample container through the septum. However, when the movable component is fully retracted into the distal position, the pressure adjustment channel may be separated from the container receptacle, so a connection, e.g. a fluidic connection, more specifically a pneumatic connection, between the sample container and the pressure chamber via the pressure adjustment channel is disrupted when the movable component is fully retracted into the distal position. Consequently, the low-pressure may be transferred from the pressure chamber into the inner space of the sample container via the pressure adjustment channel during a part of the retraction of the movable component from the proximal position into the distal position, whereas, when the distal position is reached, the connection between the inner space of the sample container and the pressure adjustment channel is disrupted, while the low-pressure in the inner space of the sample container persists and may suck the sample, through the sample collection channel, into the inner space of the sample container.

[0043] As also outlined above, the pressure chamber specifically may contain a sealed volume of gas, specifically a sealed volume of air. Therefore, the sampling device may be configured such that an exchange of gas, specifically air, between the volume comprised by the pressure chamber and the surrounding environment is essentially prevented. For this purpose, the pressure chamber specifically may be a sealed space, having one or more sealing elements. The pressure chamber specifically may be defined by a wall of the stationary component, such as a cylindrical inner wall of tubular section or a shell of the stationary component, and may further be defined by a front plate of the stationary component facing the application side, and by a part of the movable component. More specifically and as already mentioned above, the part of the movable component defining the pressure chamber may be selected from the group consisting of: a piston; a penetration element carrier. Thus, the movable component specifically may comprise a piston, such as a piston of a syringe, which moves within the movable component. Thus, the movable component may fully or partially be embodied as a piston of a syringe and / or may comprise a piston. Specifically on a side facing the application side, the movable component may further comprise at least one penetration element carrier, such as a ring carrying one or more penetration elements. The stationary component may comprise a tubular inner space, having one or more cylindrical walls, for guiding the piston and / or the penetration element carrier of the movable component. The piston and / or the penetration element carrier may be sealed against the walls of the stationary component.

[0044] As further outlined above, the penetration element may fully or partially be mounted to, such as integrated into, the movable component. More specifically, in case the movable component comprises a piston, the penetration element may be directly or indirectly mounted to the piston. As an example, the penetration element may protrude from the piston, through the pressure chamber, to the application side of the sampling device. The penetration element, as an example, may be mounted to the piston by molding techniques, such as insert molding. Additionally or alternatively, the at least one penetration element may be mounted to at least one penetration element carrier. The term “penetration element carrier” 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 element configured for holding, mounting, guiding or orienting one or more penetration elements. As an example, the penetration element carrier may comprise a disk and / or a ring. Thus, as an example, in a movement from the distal position to the proximal position, the piston may push on to the penetration element carrier. The piston may loosely rest on the penetration element carrier or may be attached to the penetration element carrier. One or both of the piston and the penetration element may be sealed against the surrounding stationary component.

[0045] The part of the movable component defining the pressure chamber specifically may be sealed against the wall of the stationary component. Thus, as an example, the piston may, by itself, have an elastomeric or soft plastic rim gliding over the inner wall of the stationary component, such that an evasion of gas from the pressure chamber into the ambient environment during compression of the pressure chamber and / or an ingression of gas into the pressure chamber from the ambient environment during expansion of the pressure chamber is at least essentially prevented. Additionally or alternatively, the penetration element carrier carrying one or more penetration elements may comprise one or more sealing elements, such as one or more sealing disks and / or sealing rings made of one or more elastomeric materials and gliding over the inner wall of the stationary component, such that an evasion of gas from the pressure chamber into the ambient environment during compression of the pressure chamber and / or an ingression of gas into the pressure chamber from the ambient environment during expansion of the pressure chamber is at least essentially prevented. Similarly, the front plate of the stationary component may also be sealed, by at least one sealing, in order to avoid an exchange of gas between the ambient environment and the pressure chamber, specifically, the front plate of the stationary component may comprise a sealing such as a septum. The sealing, specifically the septum, as an example, may be provided by a plate or foil made of at least one elastomeric material. The septum specifically may be pierced by the penetration element when the movable component moves from the distal position into the proximal position. Thus, as already mentioned above, when moving the movable component from the distal position into the proximal position, the penetration element may pass through the pressure chamber, pierce the sealing, specifically the septum, and protrude, on the application side, from the front plate of the stationary component. The channels in the front plate, through which the penetration element passes, may be sealed by the sealing of the front plate, specifically by the septum of the front plate. The sample collection channel, specifically the cannula, specifically may be mounted to the front plate and may protrude, through the pressure chamber, into the movable component.

[0046] The sampling device may further comprise one or more spring elements. Thus, one or more spring elements may be provided connecting the stationary component and the movable component. The connection may be present in all positions of the movable device, or a connection may be disrupted in one or more of the positions. The at least one spring element, as an example, may provide at least one biasing spring element for biasing the movable component against the stationary component, specifically such that, in an unused state, the movable component is pushed into the distal position by at least one of the spring elements. Additionally or alternatively, the sampling device may further comprise one or more retraction spring elements. The at least one retraction spring element specifically may retract the penetration element and / or the movable component after penetration of the skin, urging the movable component back into the distal position. Thus, generally, the movable component may be biased against the stationary component by at least one spring element. The spring element or, if a plurality of spring elements is provided, at least one of the spring elements, specifically may comprise a return spring exerting a spring force, also referred to as a retraction spring force, onto the movable component for urging the movable component from the proximal position back into the distal position, over the entire travel distance or over a part of it.

[0047] The sampling device may further comprise at least one penetration spring element. The penetration spring element may specifically be configured for urging the penetration element carrier and the at least one penetration element into the proximal position. Thus, the penetration spring element may in particular facilitate penetration of the skin of the user by the penetration elements.

[0048] As outlined above, the at least one sample container, specifically having a septum, may be received within the container receptacle in the movable component. More specifically, this container receptacle may be embodied for adapting one or more types of sample containers to the sampling device. Generally, a simple exchange of the sample containers is preferable. For this purpose, the movable component specifically may comprise at least one removable container adapter containing the container receptacle. The sampling device or the sampling kit specifically may comprise a plurality of removable container and adapters for adapting different types of sample containers to the sampling device.

[0049] The movable component specifically may further comprise at least one upper movable component, the upper movable component mounting the removable container adapter to the stationary component. More specifically, the upper movable component may at least partially surround the removable container adapter. Thus, as an example, the upper movable component may form a sleeve fully or partially surrounding the removable container adapter. The upper movable component may be slidably mounted to the stationary component. Thus, when the movable component moves from the distal position into the proximal position or vice versa, the upper movable component may glide across at least one surface of the stationary component, e.g. over outer circumferential cylindrical surface of the stationary component.

[0050] The upper movable component may be releasably attached to the removable container adapter. Thus, as an example, at least one connection element may be provided, such as at least one connecting spring, releasably attaching the removable container adapter to the upper movable component, or vice versa. The connection may be such that, in an initial state of the sampling device, the upper movable component is attached to the removable container, and, after performing a sampling action, e.g. a sampling action comprising a movement of the movable component from the distal position into the proximal position and back into the distal position, the upper movable component, and the container adapter are detached from each other, such that, as an example, the container adapter and the sample container, with the sample received therein, may be removed from the movable component of the sampling device. Thereby, the sample container filled with sample of bodily fluid may be removed from the sampling device. As outlined above, the movement of the movable component may be limited. The limitations may define the distal position and / or the proximal position. Specifically, the movement of the movable component may be limited by at least one stop, specifically by at least one stop defining the distal position and / or at least one stop defining the proximal position. The stop, as an example, may provide for one or more abutment surfaces, wherein the movable component may abut the one or more abutment surfaces during movement.

[0051] As outlined above, the movement of the movable component may be staggered. Specifically the movement of different elements of the movable component from the distal position into the proximal position may take place in a staggered fashion. In particular, the sampling device, specifically the stationary component, may comprise at least one retardation element, which may also be referred to as a brake. The term “retardation 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 structure or component configured for delaying, staggering and / or at least temporarily preventing the movement of the movable component and / or of one or more of its elements. As an example, the stationary component, e.g. the sleeve or cylindrical wall formed by the stationary component and surrounding the penetration element, may comprise at least one retardation element in the form of at least one wall thickening of the cylindrical wall, e.g. a spherical or hemispherical wall thickening such as a bulge. The cylindrical wall may comprise at least one flexible wall section flanking or surrounding the wall thickening, wherein the flexible wall section may be a section, where the thickness of the wall is reduced such that the wall section is bendable. The movable component, specifically the movable body, may comprise at least one recess configured for receiving the retardation element, specifically the wall thickening, when the movable component, specifically movable body, is in or close to the proximal position.

[0052] The wall thickening of the stationary component may protrude outwardly towards the movable body of the movable component. When the movable component, specifically the movable body, is moved from the distal position to the proximal position, the force exerted by the user may press the flexible wall section comprising the wall thickening inwardly into the space confined by the cylindrical wall of the stationary component, e.g. into the pressure chamber. The wall thickening may thus reduce the circumference of the pressure chamber, thus obstructing the movement of the penetration element carrier and / or the piston, keeping them in the distal position, while the movable body moves towards the proximal position. When the movable body is in or close to the proximal position, the wall thickening may bounce into the recess of the movable body, thus allowing the piston and / or the penetration element carrier to move unhindered past the retardation element and into the proximal position. The movement of the movable body and the penetration element carrier from the distal position into the proximal position may thus take place in a staggered fashion. The movement of the penetration element carrier towards the proximal position may be supported by at least one penetration spring element. Specifically, the penetration element carrier may be pushed towards the proximal position by the penetration spring element. As an example, the penetration spring element may comprise at least one penetration spring exerting a spring force onto the movable component, specifically onto the penetration element carrier, from the distal position into the proximal position.

[0053] In a further aspect of the present invention, a sampling kit for sampling bodily fluid is proposed. The term “kit”, 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 plurality of components being configured to interact to fulfill at least one common purpose. Consequently, the term “sampling kit”, 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 kit configured to fulfill the purpose of collecting a sample, specifically a liquid sample, more specifically a sample of the bodily fluid.

[0054] The sampling kit comprises at least one sampling device as proposed herein, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below. The sampling kit further comprises at least one sample container having a septum, the sample container being receivable in the container receptacle of the sampling device.

[0055] As outlined above, the sample container specifically may be a sample tube, specifically a standardized sample tube for laboratory analysis.

[0056] As discussed in the context of known systems and methods, the sampling kit may be flexible with respect to the type of sample containers used. Thus, specifically, one or more commercially available sample containers may be implemented. Further, the at least one sample container may also contain at least one reagent. Thus, specifically, the sample container may comprise at least one reagent configured for reacting with at least a part of the sample, specifically at least one anticoagulant. In a further aspect of the present invention, a method for generating an underpressure in a sample container having a septum is proposed. The method comprises the following steps which specifically may be performed in the given order. A different order, however, is also feasible. Further, two or more or even all of the method steps may be performed sequentially or overlapping in time or even simultaneously. Further, one or more or even all of the method steps may be performed once or repeatedly. The method may contain additional method steps which are not listed.

[0057] The method comprises: a. receiving the sample container in a container receptacle of a sampling device according to the present invention, such as according to any one of the embodiments described above and / or according to any one of the embodiments described in further detail below; b. moving the movable component from the distal position into the proximal position; and c. retracting the movable component back from the proximal position into the distal position, wherein an underpressure generated in the pressure chamber is transferred, via the pressure adjustment channel, into the sample container through the septum.

[0058] For possible embodiments of the method, as well as for possible definitions, reference may be made to the description of the sampling device above. In particular, step c. may comprise that the pressure in the sample container is adjusted via the pressure adjustment channel to an underpressure generated in the pressure chamber. The method for generating an underpressure in a sample container specifically may be part of a method for sampling a bodily fluid. Thus, specifically, a method for sampling a bodily fluid may be proposed, comprising the following steps, which, as an example, may be performed in the given order or in a different order: i. penetrating the skin of the user by using the penetration element of the sampling device, e.g. by moving the movable component from the distal position into the proximal position when the application side of the stationary component rests on the skin of the user; ii. using the method for generating an underpressure in a sample container, as defined above, for generating an underpressure or low-pressure in the sample container; and iii. transporting sample from the application side, specifically from the skin of the user, into the container receptacle, specifically into the sample container through the septum, specifically driven by the underpressure generated in step ii.. The sampling device, the sampling kit and the methods as proposed herein provide a large number of advantages over known devices, kits and methods of similar kind. Thus, specifically, the above-mentioned technical challenges of known means and methods may be efficiently addressed.

[0059] Thus, the sampling device and the sampling kit may use a sample container having a lid containing a septum. The sample container may be inserted into the sampling device with the lid closed and may, after sampling, be removed from the sampling device with the lid closed, too. Consequently, since the sample container may be in a closed state during the entire sampling procedure, there is generally no necessity for opening the container, such as by opening the lid.

[0060] As outlined above, for sampling, a low-pressure may be generated in the sample container, the low-pressure supporting the sampling. Thus, due to the low-pressure, capillary blood may be selected from the orifice of the sample collection channel into the sample container.

[0061] Generally, by using the invention, massaging or compressing the incision site may be avoided. This is due to the fact that the low-pressure, which even may be a vacuum, sucks the blood into the sample container. The avoiding of massaging or compressing the body tissue may even increase reproducibility of the quality of the sample, since, as an example, massaging or compressing may add interstitial fluid to the sample, when capillary blood is desired, wherein the interstitial fluid has a different composition as compared to capillary blood.

[0062] Further, due to the option of having the sample container in a closed state during the sampling, a precise positioning and orienting of the sampling device and, specifically, the sample container, is of lower importance. Specifically, the sample container may be in a basically arbitrary orientation with respect to the body tissue. There is generally no need for having the sample container in a position below the incision site. Even a movement of the body part in which the sampling takes place as possible during sampling is possible.

[0063] Further, the above-mentioned challenge of avoiding contamination of the surrounding environment and / or the user’s personal belongings is addressed by the invention. Since the sample container may be kept in a closed state during sampling and may be removed from the sampling device in a closed state, contamination and pollution may efficiently be avoided. Last not least is the invention applicable with standardized sample containers. Specifically, any type of standardized sample container having a septum, e.g. a lid with a septum, may be used with the sampling device and the sampling kit according to the invention. Further, commercially available sample containers may be used. Further, sample containers having one or more chemically active substances disposed therein, e.g. configured for reacting with the sample or with a part thereof, may be used. As an example, sample containers having received therein at least one suitable anticoagulant may be used with the sampling device and the sampling kit according to the invention. Further, by using standardized sample containers, sample containers may be used which are compatible with the laboratory automation equipment. The option of using different kind of container adapters also provides the advantage of working with different kinds of laboratory automation systems.

[0064] Summarizing and without excluding further possible embodiments, the following embodiments may be envisaged:

[0065] Embodiment 1 : A sampling device for sampling bodily fluid, comprising at least one stationary component and at least one movable component being mounted to the stationary component in a movable manner relative to the stationary component, wherein the movable component is movable from at least one distal position to at least one proximal position and back, wherein the stationary component has an application side, wherein the movable component comprises at least one penetration element configured for penetrating the skin of a user, wherein the penetration element, in the distal position of the movable component, is received within the stationary component and wherein the penetration element, in the proximal position of the movable component, protrudes from the application side of the stationary component, wherein the movable component comprises a container receptacle for receiving at least one sample container having a septum, wherein the sampling device further comprises at least one sample collection channel arranged for transporting sample from the application side, specifically from the skin of the user, into the container receptacle, specifically into the sample container through the septum, wherein the sampling device further comprises a pressure chamber having a volume being dependent on the position of the movable component, wherein the volume when the movable component is in the proximal position is smaller than the volume when the movable component is in the distal position, wherein the sampling device further comprises at least one pressure adjustment channel configured for transferring underpressure from the pressure chamber into the sample container through the septum when the movable component is retracted from the proximal position into the distal position. Embodiment 2: The sampling device according to the preceding embodiment, wherein the sampling device comprises a cannula, with a tip protruding into the container receptacle, specifically into the sample container through the septum.

[0066] Embodiment 3 : The sampling device according to the preceding embodiment, wherein the cannula is separate from the penetration element.

[0067] Embodiment 4: The sampling device according to any one of the two preceding embodiments, wherein the cannula comprises at least one orifice at the application side of the stationary component.

[0068] Embodiment 5 : The sampling device according to the preceding embodiment, wherein the stationary component, on the application side, comprises a sampling recess facing the skin of the user, with the orifice being located in the sampling recess.

[0069] Embodiment 6: The sampling device according to the preceding embodiment, wherein the penetration element passes through the sampling recess when the movable component is moved from the distal position into the proximal position.

[0070] Embodiment 7: The sampling device according to any one of the five preceding embodiments, wherein the cannula is mounted to the stationary component.

[0071] Embodiment 8 : The sampling device according to the preceding embodiment, wherein the tip protrudes into the container receptacle in all positions of the movable component, specifically into the sample container through the septum.

[0072] Embodiment 9: The sampling device according to any one of the seven preceding embodiments, wherein the pressure adjustment channel is at least partially integrated with the cannula.

[0073] Embodiment 10: The sampling device according to the preceding embodiment, wherein the sample collection channel is separate from the pressure adjustment channel.

[0074] Embodiment 11 : The sampling device according to any one of the two preceding embodiments, wherein the cannula is a double-walled cannula, with the sample collection channel being formed by a central lumen of the double-walled cannula, and with the pressure adjustment channel being formed by a ring-shaped space concentrically surrounding the central lumen.

[0075] Embodiment 12: The sampling device according to any one of the preceding embodiments, wherein a length of the sample collection channel exceeds a length of the pressure adjustment channel.

[0076] Embodiment 13: The sampling device according to any one of the preceding embodiments, wherein the pressure adjustment channel, at least during a part of the movement of the movable component from the proximal position into the distal position, protrudes into the container receptacle, specifically into the sample container through the septum, wherein the pressure adjustment channel, when the movable component is fully retracted into the distal position, is separated from the container receptacle, so a connection, specifically a fluidic connection, more specifically a pneumatic connection, between the sample container and the pressure chamber via the pressure adjustment channel is disrupted.

[0077] Embodiment 14: The sampling device according to any one of the preceding embodiments, wherein the pressure chamber is a sealed space.

[0078] Embodiment 15: The sampling device according to any one of the preceding embodiments, wherein the pressure chamber is defined by a wall of the stationary component, by a front plate of the stationary component facing the application side, and by a part of the movable component.

[0079] Embodiment 16: The sampling device according to the preceding embodiment, wherein the part of the movable component defining the pressure chamber is selected from the group consisting of a piston and a penetration element carrier.

[0080] Embodiment 17 : The sampling device according to the preceding embodiment, wherein the penetration element is directly or indirectly, specifically via at least one penetration element carrier, mounted to the piston.

[0081] Embodiment 18: The sampling device according to any one of the three preceding embodiments, wherein the part of the movable component defining the pressure chamber is sealed against the wall of the stationary component. Embodiment 19: The sampling device according to any one of the four preceding embodiments, wherein the front plate of the stationary component comprises a sealing, specifically at least one sealing element, more specifically at least one septum.

[0082] Embodiment 20: The sampling device according to the preceding embodiment, wherein the sealing, specifically the septum, is pierced by the penetration element when the movable component moves from the distal position into the proximal position.

[0083] Embodiment 21 : The sampling device according to any one of the six preceding embodiments, wherein the sample collection channel, specifically the cannula, is mounted to the front plate and protrudes, through the pressure chamber, into the movable component.

[0084] Embodiment 22: The sampling device according to any one of the preceding embodiments, wherein the movable component is biased against the stationary component by at least one spring element.

[0085] Embodiment 23 : The sampling device according to the preceding embodiment, wherein the spring element comprises a return spring exerting a spring force onto the movable component for urging the movable component from the proximal position back into the distal position.

[0086] Embodiment 24: The sampling device according to any one of the two preceding embodiments, wherein the spring element comprises at least one penetration spring exerting a spring force onto the movable component, specifically onto the penetration element carrier, from the distal position into the proximal position.

[0087] Embodiment 25: The sampling device according to any one of the preceding embodiments, wherein the movable component comprises a removable container adapter containing the container receptacle.

[0088] Embodiment 26: The sampling device according to the preceding embodiment, wherein the movable component further comprises at least one upper movable component, the upper movable component mounting the removable container adapter to the stationary component.

[0089] Embodiment 27 : The sampling device according to the preceding embodiment, wherein the upper movable component at least partially surrounds the removable container adapter. Embodiment 28: The sampling device according to any one of the two preceding embodiments, wherein the upper movable component is slidably mounted to the stationary component.

[0090] Embodiment 29: The sampling device according to any one of the preceding embodiments, wherein the movement of the movable component is limited by at least one stop, specifically by at least one stop defining the distal position and / or at least one stop defining the proximal position.

[0091] Embodiment 30: The sampling device according to any one of the preceding embodiments, wherein the sampling device, specifically the stationary component, comprises at least one retardation element configured for staggering the movement of the movable component from the distal into the proximal position.

[0092] Embodiment 31 : The sampling device according to the preceding embodiment, wherein the movable component comprises a plurality of parts, wherein the movement of a first subset of parts of the movable component is staggered and / or delayed with respect to the movement of a second subset of parts of the movable component by the retardation element.

[0093] Embodiment 32: The sampling device according to any one of the two preceding claims, wherein the retardation element comprises at least one wall thickening, specifically at least one bulge, in a wall of the stationary component.

[0094] Embodiment 33: The sampling device according to any one of the two preceding claims, wherein the movable component comprises at least one recess for receiving the retardation element, specifically the wall thickening, wherein the first subset of parts of the movable component moves from the distal into the proximal position, when the retardation element is received in the recess.

[0095] Embodiment 34: A sampling kit for sampling bodily fluid, the sampling kit comprising at least one sampling device according to any one of the preceding embodiments, the sampling kit further comprising at least one sample container having a septum, the sample container being receivable in the container receptacle of the sampling device. Embodiment 35 : The sampling kit according to the preceding embodiment, wherein the sample container is a sample tube, specifically a standardized sample tube for laboratory analysis.

[0096] Embodiment 36: The sampling kit according to any one of the preceding embodiments referring to a sampling kit, wherein the sample container comprises at least one reagent configured for reacting with at least a part of the sample, specifically at least one anticoagulant.

[0097] Embodiment 37: A method for generating an underpressure in a sample container having a septum, comprising: a. receiving the sample container in a container receptacle of a sampling device according to any one of the preceding embodiments referring to a sampling device; b. moving the movable component from the distal position into the proximal position; and c. retracting the movable component back from the proximal position into the distal position, wherein an underpressure generated in the pressure chamber is transferred, via the pressure adjustment channel, into the sample container through the septum.

[0098] Short description of the Figures

[0099] 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.

[0100] In the Figures:

[0101] Figure 1 shows a cross-sectional view of an embodiment of a sampling device and a sampling kit;

[0102] Figure 2 shows a perspective view of a detail of the sampling device of Figure 1;

[0103] Figure 3 shows a perspective view of the sampling device of Figure 1; Figures 4 to 6 show the sampling device and the sampling kit of Figure 1 in cross- sectional views, in subsequent situations occurring during sampling;

[0104] Figures 7 to 9 show cross-sectional views of different states of assembly of the components of the sampling device of Figure 1;

[0105] Figures 10 to 12 show different views of the sample container and of a container adapter being part of the sampling device of Figure 1;

[0106] Figure 13 shows a detailed cross-sectional view of a sampling site of the sampling device of Figure 1;

[0107] Figures 14 to 16 show detailed cross-sectional views of the sample container during subsequent steps of sampling;

[0108] Figures 17 to 19 show detailed cross-sectional views of the sampling site in subsequent situations of sampling;

[0109] Figure 20 shows a cross-sectional view of the stationary component comprising at least one retardation element;

[0110] Figures 21 to 22 show a perspective view (Figure 21) and a cross-sectional view (Figure 22) of a penetration element carrier connected to two spring elements; and

[0111] Figure 23 shows a flowchart of embodiments of a method of sampling bodily fluid and of a method for generating an underpressure in a sample container.

[0112] Detailed description of the embodiments

[0113] In Figures 1 to 19, an exemplary embodiment of a sampling device 110 for sampling bodily fluid, as well as an exemplary embodiment of a sampling kit 112 comprising the sampling device 110 and a sample container 114 is shown in various views, states, and details. Therein, Figure 1 shows a cross-sectional view of the sampling device 110 and the sampling kit 112. Figure 2 shows a perspective view of a detail of the sampling device 110. Figure 3 shows a perspective view of the sampling device 110. Figures 4 to 6 show the sampling device 110 and the sampling kit 112, in cross-sectional views, in subsequent situations occurring during sampling. Figures 7 to 9 show cross-sectional views of different states of assembly of the components of the sampling device 110. Figures 10 to 12 show different views of the sample container 114 and of a container adapter 116 being part of the sampling device 110. Figure 13 shows a detailed cross-sectional view of a sampling site of the sampling device 110. Figures 14 to 16 show detailed cross-sectional views of the sample container 114 during subsequent steps of sampling. Figures 17 to 19 show detailed cross-sectional views of the sampling site in subsequent situations of sampling. Figures 1 to 19, in the following, will be described in conjunction.

[0114] The setup of the sampling device 110 and the sampling kit 112 will mainly be described with respect to the cross-sectional view shown in Figure 1. The sampling device 110 comprises at least one stationary component 118, which may also be referred to as a lower part. Further, the sampling device 110 comprises at least one movable component 120 being mounted to the stationary component 118 in a movable manner relative to the stationary component 118. Specifically, the movable component 120 may be movable in a linear fashion, parallel to an axis of penetration 122. The movable component 120, in the embodiment shown herein, may comprise the container adapter 116, as well as one or more further components. Specifically, the movable component 120 may comprise an upper movable component 124, which may also be referred to as an upper part, wherein the upper movable component 124 may surround the container adapter 116 and may also partially surround the stationary component 118, e.g. as a slidable sleeve.

[0115] The movable component 120 is movable from at least one distal position, as shown e.g. in Figure 4, to a proximal position, as shown e.g. in Figure 5 and backwards, e.g. into a distal position shown in Figure 6. Therein, the distal positions in Figures 4 and 6, i.e. before and after use of the sampling device 110, may be identical or may not be identical. Therein, the movement from the distal position in Figure 4 into the proximal position of Figure 5, may be denoted as a penetration direction 126, as indicated in Figure 1, and the opposite direction, i.e. the direction of movement from the proximal position of Figure 5 back into the at least one distal position, as shown e.g. in Figure 6, may be denoted as a retraction direction 127.

[0116] The stationary component 118 has an application side 128. Specifically, the stationary component 118 comprises at least one application surface 130, by which the stationary component 118 may be applied to the skin of the user. Details of the application surface 130 and the setup of the stationary component 118 in the range of the application surface 130 will be explained in further detail below, specifically with respect to Figure 13, and with respect to Figures 17 to 19.

[0117] The sampling device 110 further comprises at least one penetration element 132, which, specifically, is part of the movable component 120, i.e. the penetration element moves with the movable component 120. In the setup shown in the present embodiment, a plurality of penetration elements 132, e.g. four penetration elements, may be present, which may be arranged concentrically and / or with rotational symmetry about the axis of penetration 122. Thus, specifically, penetration elements 132 may form a ring of penetration elements 132, such as a lancet ring, or may be comprised by a ring of penetration elements or lancet ring. The penetration elements 132 may be held by, mounted by or comprised by at least one penetration element carrier 147, which may directly or indirectly rest on a piston 146, as will be outlined in further detail below. The penetration element carrier, as an example, may comprise, as an example, a ring and / or a disk, e.g. a molded ring or disk, with the one or more penetration elements 132 attached thereto, e.g. by insert molding or the like. As will also be outlined in further detail below, the movable component 120, specifically the penetration element carrier 147, may also comprise one or more sealings 148. Other embodiments, however, are also feasible. The penetration element 132 is configured for penetrating the skin of the user when the movable component 120 moves from the distal position into the proximal position. In the at least one distal position of the movable component 120, the penetration element 132 may be received within the stationary component 118, as shown e.g. in Figures 4 and 6, whereas, in the proximal position, as shown in Figure 5, the penetration element 132 protrudes from the application side 128, specifically from the application surface 130, such that the penetration element 132 may penetrate the skin of the user, onto which the application surface 130 is applied.

[0118] The sampling device 110, specifically the movable component 120, further comprises a container receptacle 134. The container receptacle 134, as will be shown in further detail below with respect to Figures 10 and 11, is formed by the container adapter 116. The container receptacle 134 may be a space which is fully or partially surrounded by the movable component 120. Nevertheless, part of the space defining the container receptacle 134 may also be surrounded by the stationary component 118. The container receptacle 134, however, is movable with the movable component 120, such that a sample container 114 received therein moves with the movable component. The sample container 114, as shown e.g. in Figures 1, 4 to 6, 10 to 12 or 14 to 16, has a septum 136 forming a lid or cover or being part of a lid or cover of the sample container 114. The septum 136, specifically, may face the application side 128 when the sample container 114 is received in the container receptacle 134. The sampling device 110 further comprises a sample collection channel 138 arranged for transporting sample from the application side 128 into the container receptacle 134, specifically through the septum 136 into the sample container 114 received in the container receptacle 134. The sample collection channel 138 specifically is visible in Figure 13 and will subsequently also be explained with respect to said Figure.

[0119] The sampling device 110 further comprises at least one pressure chamber 140, which also may be referred to as a syringe chamber. The pressure chamber 140, in this embodiment, specifically may be walled by a circumferential wall 142 of the stationary component 118, by a front plate 144 of the stationary component 118 facing the application side 128, and by a part of the movable component 120. The part of the movable component 120 forming a sidewall of the pressure chamber 140 specifically may be a piston 146 and / or a plunger, moving up and down along the axis of penetration 122 with the movable component 120. Additionally or alternatively, as will be outlined in further detail below with respect to Figure 8, the part of the movable component 120 forming a sidewall of the pressure chamber 140 also may be the penetration element carrier 147, carrying the one or more penetration elements 132. The piston 146 and / or the penetration element carrier 147 specifically may have a sealing 148, specifically a sealing ring, for sealing the pressure chamber 140. On the side of the front plate 144, a further sealing 150 may be provided. Thus, as an example, front plate 144 may comprise a perforated plate 152, with the sealing 150 disposed thereon, on a side facing the pressure chamber 140. As an example, sealing 150 may be configured as a septum, which may be pierceable or puncturable by the penetration element 132.

[0120] The pressure chamber 140 has a variable volume. Specifically, the volume of the pressure chamber 140 is dependent on the position of the movable component 120. As can be seen by comparing the volume of the pressure chamber 140 in Figures 4 and 6, when the movable component 120 is in the at least one distal position, with the volume of the pressure chamber 140 in Figure 5, the volume of the pressure chamber 140, generally, when the movable component 120 is in the proximal position, is smaller than the volume when the movable component 120 is in the distal position. The pressure chamber 140 generally may be filled with gas, specifically with air. The pressure chamber 140 may provide for a closed environment or closed amount of gas, in which, by the movement of the movable component 120, the gas, specifically the air, may be compressed or expanded, respectively. Thus, specifically, when the movable component 120 moves in the penetration direction 126, the amount of gas in the pressure chamber 140 may be compressed, whereas, when the movable component 120 moves in the retraction direction 127, the amount of gas in the pressure chamber 140 is expanded, thereby creating a low-pressure, also referred to as an underpressure or a vacuum.

[0121] The above-mentioned sealing of the pressure chamber 140, however, is not a complete isolation of the amount of gas within the pressure chamber 140. This is due to the fact that the sampling device 110 further comprises a pressure adjustment channel 154 which creates a connection, e.g. a pneumatic connection, between the pressure chamber 140 and the container receptacle 134, specifically the sample container 114 received in the container receptacle 134. The pressure adjustment channel 154 can be seen, specifically, in Figures 13 and 14 to 16 and will be described with respect to said Figures in further detail below. By this pressure adjustment channel 154, having an opening 156 within the pressure chamber 140 and a further opening 158 within the container receptacle 134, the pressure adjustment channel 154 is configured for transferring an underpressure from the pressure chamber 140 into the sample container 114 through the septum 136 when the movable component 120 is retracted from the proximal position into the distal position. In other words, a pressure equalization between the pressure chamber 140 and at least a part of the container receptacle 134, specifically an inner space of the sample container 114, is possible, specifically as long as opening 158 is located within the inner space of the sample container 114.

[0122] The movement of the movable component 120 along axis of penetration 122 may be limited in various ways, in order to define one or more of the proximal position and the distal position. Thus, as an example, the sampling device 110 may comprise one or more abutment elements 160. Thus, as an example, as can be seen, e.g. in Figure 1, the stationary component 118 may comprise an abutment element 160, such as an abutment pin, protruding radially from the stationary component 118, wherein the abutment element 160 may be guided in a slot 162 of the upper movable component 124 surrounding the stationary component 118 in the region of the abutment element 160. The length of the slot 162 may define the range of movement and, specifically, may define the proximal position and / or the distal position. However, it shall be noted that other limitations may be present in addition or alternatively. Further, other ways of providing abutment elements 160 are also feasible.

[0123] The sampling device 110 further comprises a plurality of spring elements. Thus, as an example, at least one connecting spring 164 may be provided, which, in the unused state shown e.g. in Figures 1 and 4, holds the upper movable component 124 to the stationary component 118, by engaging with spring receptacle 166. During use, e.g. when the movable component 120 moves into the penetration direction 127, the connecting spring 164 may disengage from the spring receptacle 166, as shown e.g. in Figure 5. Further, the sampling device 110 may comprise a biasing spring 168, which, as an example, may be provided in a ring space 170 between the upper movable component 124 and the stationary component 118. The biasing spring 168 may exert a biasing spring force onto the movable component 120, pushing the movable component 120 into the retraction direction

[0124] 127. Specifically, by this biasing force, the movable component 120 may be held in the distal position in the unused state, and an unwanted disengagement of the connecting spring 164 with spring receptacle 166 may be prevented.

[0125] Further, the sampling device 110 may comprise additional spring elements, such as at least one retraction spring element 172 located in the pressure chamber 140. The retraction spring element 172, specifically, may support a retraction movement of the penetration element 132. Thus, as an example, the retraction spring element 172 may be located between the front plate 144 and the penetration element carrier 147 and / or between the front plate 144 and the piston 146. Specifically in case the penetration element carrier 147 is not fixedly attached to the piston 146, the retraction spring element 172 may support a retraction movement of the penetration element 132 when the piston 146 is retracted. The retraction spring element 172, as an example, may be fixedly attached, with one side, to the piston 146 and / or to the penetration element carrier 147, whereas the opposing side, facing the application side

[0126] 128, may be loose, as will be outlined in further detail below with respect to Figure 19. Other embodiments, however, are also feasible.

[0127] As outlined above, the sampling device 110, comprises at least one sample collection channel 138 and at least one pressure adjustment channel 154, both channels fulfilling different purposes, and, thus, being separate channels. Nevertheless, channels 138 and 154 may also be integrated into one and the same element, as shown exemplarily in the embodiment of the figures.

[0128] Specifically, the sampling device 110 may comprise a cannula 174, with a tip 176 protruding into the container receptacle 134, specifically into an inner space of the sample container 114 received in the container receptacle 134, through the septum 136 close to the tip 176, an opening 178 is provided. The sample collection channel 138 extends axially, specifically on- axis, with respect to axis of penetration 122, from an orifice 180 on the application side 128 to opening 178 in the container receptacle 134, specifically in the inner space of the sample container 114. Specifically, as can be seen, e.g. in Figure 13, cannula 174 may protrude through the front plate 144, into a sampling recess 182 in the application surface 130. In the sampling recess 182, as also shown in Figure 13, orifice 180 of the inner wall 186 of double walled cannula 174 may be surrounded by one or more spacers 183, such as spacer pins, which allow for bodily fluids to reach orifice 180 and which, still, prevent orifice 180 from directly resting on the body surface, and, thereby preventing access for the bodily fluid. Thus, the spaces 183 may provide for a controlled and / or predetermined distance between orifice 180 at the surface of the user’s body.

[0129] Thereby, sample may be collected and guided from orifice 180, through the sample collection channel 138, to the opening 178, specifically into the inner space of the sample container 114 received in the container receptacle 134. The protrusion of tip 176 specifically may be dimensioned such that opening 178 is located within the inner space of the sample container 114, at all times during movement of the movable component 120, i.e. both in the proximal position and in the distal position.

[0130] For providing the pressure adjustment channel 154, as outlined above, an integration with cannula 174 is also possible. Therefore, cannula 174 may be embodied as a double-walled cannula, having an outer wall 184 which over a part of the extension of cannula 174 along the axis of penetration 122 concentrically surrounds an inner wall 186, with a ring-shaped space 188 disposed between walls 184, 186. Again, reference may be made, as an example, to the detailed view in Figure 13. Outer wall 184 is held by a holder 190, e.g. a holder 190 mounted to front plate 144. The inner wall 186, on the other hand, may be mounted directly to the perforated plate 152 of the front plate 144. Thereby, the outer wall 184 and the inner wall 186 of cannula 174 may have different lengths, and the outer wall 184 may be shorter than the inner wall 186. Thereby, ring-shaped space 188 and, thus, pressure adjustment channel 154 may lead, from opening 156 to opening 158 which is separate from opening 178 of the central lumen of cannula 174 forming the sample collection channel 138. Reference may also be made to Figures 2 and 14 to 16. Thus, cannula 174 may also be considered as a combination of a short cannula, being formed by the outer wall 184, extending from opening 156 to opening 158 and providing the ring-shaped space 188 forming the pressure adjustment channel 154, and a long cannula, being formed by the inner wall 186, leading from orifice 180 to opening 178 and providing a central lumen forming the sample collection channel 138.

[0131] As can be seen in Figures 4 to 6 and in Figures 17 to 19, during movement of the movable component 120 from the distal position to the proximal position, penetration element 132 specifically may pass through the pressure chamber 140 and through the front plate 144. For this purpose, perforated plate 152 may provide for one or more lancet openings 194, through which the penetration element 132 may protrude during penetration movement. These lancet openings 194 are also visible in the detailed view of Figure 13. The penetration element 132 may further protrude through holder 190, as also visible in Figure 13. For this purpose, holder 190 may also provide for at least one lancet opening 196. In order to maintain sealing of the pressure chamber 140, the sealing 150 may cover the perforated plate 152, e.g. as a septum, to be pierced by the at least one penetration element 132.

[0132] In Figures 10 and 11, perspective views of the container adapter 116 and the sample container 114 are shown. In Figure 12, a cross-sectional view of an example of a sample container 114 is shown. Specifically, the sample container 114 may comprise a sample tube 198, being closed by a lid 200. The lid 200, as can be seen in the cross-sectional view of Figure 12, comprises a septum 136, which may be pierced by the tip 176 of cannula 174. The septum 136 specifically may be an internal septum. As an example, a sample tube of the type “Min- iCollecf ’ may be used, commercially available by Greiner Bio-One GmbH, 72636 Frickenhausen, Germany. Other embodiments or types of sample containers 114, however, are also feasible. The container adapter 116 may, as an example, be configured to hold the sample container 114 by clamping and / or other means. Thus, as an example, the sample container 114 may be clamped between an upper abutment 202 and a lower abutment 204, with the container receptacle 134 being disposed there between, as can be seen, e.g. in Figures 10 and 11. The container adapter 116 and / or the lid 200 may be fully or partially flexible or compressible, in order to insert and / or remove the sample container 114.

[0133] In the following, a use of the sampling device 110 and the sampling kit 112 will be described. In an initial state, as shown e.g. in Figure 4, movable component 120 of the sampling device 110 is in the distal position. The connecting spring 164 is engaged with the spring receptacle 166. The connecting spring 164 may be in a tensed state. Additionally or alternatively, biasing spring 168 may also be in a tensed or pre-tensed or biased state. The penetration element 132 is fully received within the stationary component 118 and is located above the sealing 150. The tip 176 of cannula 174 penetrates septum 136, with opening 178 of the sample collection channel 138 being located in the inner space of the sample container 114. Opening 158 of pressure adjustment channel 154, however, is located outside the inner space of sample container 114. In this unused or initial state, the sampling device 110 and the sampling kit 112 are placed, with the application surface 130, on the skin of the user. For attachment to the skin of the user, the application surface 130, in this embodiment or other embodiments, may also contain one or more adhesives. Thus, as an example, one or more adhesives, plasters, may be used, in order to adhere the sampling device 110 to the skin of the user. The sampling device 110, subsequently, and as shown e.g. in Figure 5, is activated by pushing the movable component 120 in the penetration direction 126. The movable component 120 is moved from the distal position into the proximal position. The movement, as outlined above, may be limited by abutment element 160. During movement, the connecting spring 164 disengages from the spring receptacle 166 and retracts into a recess 206 in the upper movable component 124. Biasing spring 168 is further compressed. By the movement in the penetration direction 126, the outer wall 184 of cannula 174 pierces the septum 136, so opening 158 comes to be located within the inner space of sample container 114. Further, the penetration element 132 is initiated, wherein piston 146 is moved in the penetration direction 126 and pushes onto the penetration element carrier 147, thereby pushing down penetration element 132. The penetration element 132 penetrates the sealing 150, passes through lancet opening 194 and penetrates the skin of the user. Optionally, the optional retraction spring element 172 is compressed during that process. The movable component 120 is then in the proximal position, as shown in Figure 5.

[0134] After activation as shown in Figure 5, a retraction movement takes place. Therein, the movable component 120 is moved back into the at least one distal position, and the sampling device 110 is in the used configuration or end configuration, as shown in Figure 6. For this purpose, the movable component 120 is moved back in the retraction direction 127, supported, e.g. by biasing spring 168 and / or by retraction spring element 172. Spring elements 168 and / or 172 may relax fully or partially during that process. The at least one penetration element 132 retracts from the skin of the user, back into the stationary component 118, above sealing 150. Optionally, the penetration element carrier 147, such as a lancet ring holding the one or more penetration elements 132, may be moved upwards by the retraction spring element 172. Due to the upper movement, in the retraction direction 127, of the movable component 120, a low-pressure is generated in the pressure chamber 140. As long as opening 158 is still within the inner space of the sample container 114, the low-pressure is transferred, via the pressure adjustment channel 154, into the inner space of sample container 114. Due to the upward movement of the movable component 120, however, the protrusion of the cannula 174 into the inner space of the sample container 114 is greatly reduced, until the situation shown in Figure 6 is reached. While opening 178 remains within the inner space of the sample container 114, opening 158 is retracted back to a position out of the inner space of sample container 114, similar to the situation of Figure 4, so a connection, e.g. a pneumatic connection, between the pressure chamber 140 and the inner space of sample container 114 is disrupted. Bodily fluid, specifically blood and more specifically capillary blood, gathers in a space between the perforated plate 152 and the body surface, optionally in the optional sampling recess 182. From there, the sample is sucked, via the sample collection channel 138, into the inner space of the sample container 114, driven by the low-pressure transferred from the pressure chamber 140 into the inner space of the sample container 114 via the pressure adjustment channel 154.

[0135] When the sample container 114 is filled with the sample of the bodily fluid, specifically with blood and more specifically with capillary blood, the container adapter 116, with the sample container 114 received therein, can be removed from the sampling device 110. Thus, generally, in this embodiment and other embodiments, the container adapter 116 may be detached from the upper movable component 124 after use of the sampling device 110, i.e., after performing the penetration movement. The container adapter 116, as an example, may comprise at least one grip 208 protruding from the movable component 120, by which the container adapter 116 may be pulled, in an axial direction or retraction direction 127, from the sampling device 110.

[0136] The above-mentioned explanations also illustrate the principle of generating the underpressure or low-pressure within the sample container 114 during sampling. Thus, as outlined above, the double-walled cannula 174 may be used. Therein, the shorter channel of the double-walled cannula 174, which forms the pressure adjustment channel 154, takes over the function of pneumatically connecting the pressure chamber 140 with the inner space of the sample container 114. While opening 156 is always located within the pressure chamber 140, above front plate 144, the opposing opening 158 of pressure adjustment channel 154 is located either outside the inner space of the sample container 114, which is in the initial and final state of the sampling device 110, or inside the inner space of the sample container 114, which is in the activated state or during sampling. The longer part of double-walled cannula 174, formed in this exemplary embodiment by the inner lumen of cannula 174, however, connects orifice 180 close to the body surface, where the sample of the bodily fluid is generated, with opening 178 in the inner space of the sample container 114.

[0137] In the initial state, as shown e.g. in Figures 4 and 14, opening 158 is located outside the inner space of sample container 114, while opening 178 of the sample collection channel 138 is located inside the inner space. In the activated state, as shown e.g. in Figures 5 and 15, the movable component 120 is fully pushed into the proximal position, e.g. limited by abutment element 160. In this activated state, both openings 158, 178 are located within the inner space of the sample container 114, as shown in Figure 5. Thereafter, as outlined above, movable component 120 moves back into the retraction direction 127. During that retraction movement, an underpressure or low-pressure is generated within the pressure chamber 140, which is connected, via the pressure adjustment channel 154, to the sample container 114, such that a full or at least partial pressure equalization between the pressure chamber 140 and the inner space of the sample container 114 may take place, since gas, specifically air, is sucked through the pressure adjustment channel 154 from the inner space of the sample container 114 into the pressure chamber 140, at least during a part of the retraction movement of the movable component 120.

[0138] When the movable component 120 has reached the distal position, i.e. when the sampling device 110 is in the final state after sampling, as shown e.g. in Figures 6 and 16, opening 158 of the pressure adjustment channel 154 has left the inner space of the sample container 114 through the septum 136. Thus, the pneumatic connection between the pressure chamber 140 and the inner space of sample container 114 is disrupted. The low-pressure or underpressure within the inner space of the sample container 114, however, at least partially remains, such that sample, driven by the pressure difference between orifice 180 and opening 178, is sucked into the inner space of sample container 114.

[0139] Further, embodiments are feasible. The sampling device 110 generally may be placed on various body parts, such as on an arm, a leg, a torso, a hand, a food or the like. Further, various types of bodily fluids may be sampled.

[0140] With respect to Figures 7 to 9, an optional assembly of the sampling device 110 may be explained. Thus, in Figure 7, the stationary component 118 is shown, with the integrated double-walled cannula 174, mounted to the front plate 144. In Figure 8, the setup with the penetration element 132 mounted to the stationary component 118 is shown. As outlined above, the penetration element 132 specifically may be held by the penetration element carrier 147. Further, this group of components may also comprise the retraction spring element 172. Finally, in Figure 9, the upper movable component 124 is mounted to the setup of Figure 8.

[0141] The movement of different elements of the movable component 120 from the distal position into the proximal position may take place in a staggered fashion. In particular, the sampling device 110, specifically the stationary component 118, may comprise at least one retardation element 226 configured for delaying the movement of the penetration element carrier 147 and the penetration element 132 compared to e.g. the movement of the movable body 227 and the upper movable component 124. Figure 20 shows a cross-sectional view of the stationary component 118 comprising at least one retardation element 226. The retardation element 226 may be formed by at least one wall thickening 228 of the circumferential wall 142 of the stationary component 118, e.g. by three spherical or hemispherical wall thickenings 228 protruding outwardly towards the movable body 227 of the movable component 120. As an example, the three wall thickenings 228 may be evenly spaced apart on the circumference of the circumferential wall 142 such that the distance between two wall thickenings 228 spans an angle of 120°. As also illustrated in Figure 20, the circumferential wall 142 may comprise at least one flexible wall section 230 e.g. a wall section with a reduced wall thickness, flanking and / or surrounding the wall thickenings 228. The flexible wall section 230 may be bendable such that the flexible wall section 230, and with it the retardation element 226 surrounded by the flexible wall section 230, may be deflectable as indicated by the two-sided arrow in Fig. 20. The movable body 227 of the movable component 120 may comprise at least one recess configured for receiving the retardation element 226, specifically the wall thickening 228, when the movable body 227 is in or close to the proximal position (not shown in the Figures).

[0142] When the movable body 227 is moved from the distal position to the proximal position the force exerted by the user may press the flexible wall section 230 comprising the wall thickening 228 inwardly into the space confined by the cylindrical or circumferential wall 142 of the stationary component 118, e.g. into the pressure chamber 140. The wall thickening 228 may thus obstruct the movement of the penetration element carrier 147, keeping it in the distal position, while the movable body 227 moves towards the proximal position. When the movable body 227 is in or close to the proximal position, the wall thickening 228 may bounce into the recess of the movable body 227. This may allow the penetration element carrier 147 to move past the retardation element 226 and into the proximal position in an unhindered fashion. The movement of the movable body 227 and the penetration element carrier 147 from the distal position into the proximal position may thus take place in a staggered fashion.

[0143] In the embodiment of the stationary component 118 shown in Figure 20 the circumferential wall 142 delineates an upper compartment 234 and lower compartment 236. The upper compartment 234 may comprise the pressure chamber 140. The upper compartment 234 may at least partially receive the container adapter 116 of the movable component 120, e.g. the lower abutment 204 of the container adapter 116 (not shown). The upper compartment 234 and lower compartment 236 may be separated, e.g. by at least one partition wall 238. As illustrated in Figure 20, the stationary component 118 may further comprise a number of sealing surfaces 239 for sealing against the perforated plate 152. Further, Figure 20 shows the cannula 174 in a schematic fashion. Inner wall 186 and outer wall 184 of the cannula 174 are not indicated separately in this Figure. The sampling device 110 may comprise one or more spring elements. In particular, the movement of the penetration element carrier 147 towards the proximal position may be supported by at least one penetration spring element 240. Specifically, the penetration element carrier 147 may be pushed towards the proximal position by the penetration spring element 240. Figures 21 to 22 respectively show a perspective view and a cross-sectional view of a penetration element carrier 147 connected to two spring elements. In particular, the sampling device 110 may comprise at least one penetration spring element 240 and at least one retraction spring element 172, which in Figures 21 and 22 are arranged above and below the penetration element carrier 147, respectively. As also depicted in Figures 21 and 22 both the penetration spring element 240 and the retraction spring element 172 may be arranged such as to surround the cannula 174 and the pressure adjustment channel 154 in a concentrical fashion. In particular, the penetration elements 132, four of which are shown in Figures 21 and 22, may be arranged around the penetration spring element 240 and the retraction spring element 172. The penetration spring element 240 may specifically be configured for urging the penetration element carrier 147 and the penetration element 132 towards the proximal position once the retardation element 226 has been received in the recess of the movable body 227 thus facilitating skin penetration of the user. The at least one retraction spring element 172 specifically may retract the penetration element 132 after penetration of the skin, urging the movable component 120, specifically the penetration element 132, back into the distal position. Thus, the retraction spring element 172 may enhance safety and user friendliness of the sampling device 110 by preventing permanent protrusion of the penetration element 132, which may pose a risk of injury.

[0144] In the following, an exemplary embodiment of a method for generating an underpressure or low-pressure in a sample container 114 having a septum 136 is shown, with reference to Figure 23. In Figure 23, a flow chart of an embodiment of a method of sampling a bodily fluid is shown, denoted by reference number 210, which is also proposed herein. The method for generating an under pressure or low-pressure in the sample container 114 is denoted by reference number 212 in Figure 23 and is part of method 210. Methods 210, 212 make use of a sampling device 110 and a sampling kit 112 according to the present invention. In the following, methods 210, 212, specifically are described in the context of the exemplary embodiments of the sampling device 110 and the sampling kit 112 as described above. It shall be noted, however, that other embodiments may also be used in the context of methods 210, 212. The methods 210, 212 comprise the method steps as described in the following. The method steps specifically may be performed in the given order. A different order, however, is also feasible. Further, two or more or even all of the method steps may be performed sequentially or overlapping in time or even simultaneously. Further, one or more or even all of the method steps may be performed once or repeatedly. The methods 210, 212 may contain additional method steps which are not listed.

[0145] Method 210 for sampling a bodily fluid comprises the following steps: i. (denoted by reference number 214) penetrating the skin of the user by using the penetration element 132 of the sampling device 110, e.g. by moving the movable component 120 from the distal position into the proximal position when the application side 128 of the stationary component 118 rests on the skin of the user; ii. (denoted by reference number 216) using the method 212 for generating an underpressure in a sample container 114 for generating an underpressure, also referred to as a low-pressure, in the sample container 114; and iii. (denoted by reference number 218) transporting sample from the application side 128, specifically from the skin of the user, into the container receptacle 134, specifically into the sample container 114 through the septum 136, driven by the underpressure generated in step 216.

[0146] The method 212 for generating the underpressure in the sample container 114, as used in step 216, comprises the following steps: a. (denoted by reference number 220) receiving the sample container 114 in the container receptacle 134 of the sampling device 110; b. (denoted by reference number 222) moving the movable component 120 from the distal position into the proximal position; and c. (denoted by reference number 224) retracting the movable component 120 back from the proximal position into the distal position, wherein an underpressure generated in the pressure chamber 140 is transferred, via the pressure adjustment channel 154, into the sample container 114 through the septum 136. List of reference numbers

[0147] Sampling device

[0148] Sampling kit

[0149] Sample container

[0150] Container adapter

[0151] Stationary component

[0152] Movable component

[0153] Axis of penetration

[0154] Upper movable component

[0155] Penetration direction

[0156] Retraction direction

[0157] Application side

[0158] Application surface

[0159] Penetration element

[0160] Container receptacle

[0161] Septum

[0162] Sample collection channel

[0163] Pressure chamber

[0164] Circumferential wall

[0165] Front plate

[0166] Piston

[0167] Penetration element carrier

[0168] Sealing

[0169] Sealing

[0170] Perforated plate

[0171] Pressure adjustment channel

[0172] Opening of pressure adjustment channel

[0173] Opening of pressure adjustment channel Abutment element

[0174] Slot

[0175] Connecting spring

[0176] Spring receptacle

[0177] Biasing spring

[0178] Ring space

[0179] Retraction spring element

[0180] Cannula Tip

[0181] Opening of cannula

[0182] Orifice

[0183] Sampling recess

[0184] Spacer

[0185] Outer wall

[0186] Inner wall

[0187] Ring-shaped space

[0188] Holder

[0189] Lancet opening in perforated plate

[0190] Lancet opening in holder

[0191] Sample tube

[0192] Lid

[0193] Upper abutment

[0194] Lower abutment

[0195] Recess

[0196] Grip

[0197] Method of sampling bodily fluid

[0198] Method for generating an underpressure in a sample container

[0199] Penetrating the skin

[0200] Generating underpressure in sample container

[0201] Transporting sample

[0202] Receiving sample container in container receptacle

[0203] Moving movable component from distal position to proximal position

[0204] Retracting movable component from proximal position to distal position

[0205] Retardation element

[0206] Movable body

[0207] Wall thickening

[0208] Flexible wall section

[0209] Upper compartment

[0210] Lower compartment

[0211] Partition wall

[0212] Sealing surface

[0213] Penetration spring element

Claims

Claims1. A sampling device (110) for sampling bodily fluid, comprising at least one stationary component (118) and at least one movable component (120) being mounted to the stationary component (118) in a movable manner relative to the stationary component (118), wherein the movable component (120) is movable from at least one distal position to at least one proximal position and back, wherein the stationary component (118) has an application side (128), wherein the movable component (120) comprises at least one penetration element (132) configured for penetrating the skin of a user, wherein the penetration element (132), in the distal position of the movable component (120), is received within the stationary component (118) and wherein the penetration element (132), in the proximal position of the movable component (120), protrudes from the application side (128) of the stationary component (118), wherein the movable component (120) comprises a container receptacle (134) for receiving at least one sample container (114) having a septum (136), wherein the sampling device (110) further comprises at least one sample collection channel (138) arranged for transporting sample from the application side (128) into the container receptacle (134), wherein the sampling device (110) further comprises a pressure chamber (140) having a volume being dependent on the position of the movable component (120), wherein the volume when the movable component (120) is in the proximal position is smaller than the volume when the movable component (120) is in the distal position, wherein the sampling device (110) further comprises at least one pressure adjustment channel (154) configured for transferring underpressure from the pressure chamber (140) into the sample container (114) through the septum (136) when the movable component (120) is retracted from the proximal position into the distal position.

2. The sampling device (110) according to the preceding claim, wherein the sampling device (110) comprises a cannula (174), with a tip protruding into the container receptacle (134), wherein the cannula (174) comprises at least one orifice (180) at the application side (128) of the stationary component (118).

3. The sampling device (110) according to the preceding claim, wherein the stationary component (118), on the application side (128), comprises a sampling recess (182) facing the skin of the user, with the orifice (180) being located in the sampling recess (182).

4. The sampling device (110) according to any one of the two preceding claims, wherein the cannula (174) is mounted to the stationary component (118).

5. The sampling device (110) according to any one of the three preceding claims, wherein the pressure adjustment channel (154) is at least partially integrated with the cannula (174).

6. The sampling device (110) according to the preceding claim, wherein the cannula (174) is a double-walled cannula (174), with the sample collection channel (138) being formed by a central lumen of the double-walled cannula (174), and with the pressure adjustment channel (154) being formed by a ring-shaped space concentrically surrounding the central lumen.

7. The sampling device (110) according to any one of the preceding claims, wherein a length of the sample collection channel (138) exceeds a length of the pressure adjustment channel (154).

8. The sampling device (110) according to any one of the preceding claims, wherein the pressure adjustment channel (154), at least during a part of the movement of the movable component (120) from the proximal position into the distal position, protrudes into the container receptacle (134), wherein the pressure adjustment channel (154), when the movable component (120) is fully retracted into the distal position, is separated from the container receptacle (134), so a connection between the sample container (114) and the pressure chamber (140) via the pressure adjustment channel (154) is disrupted.

9. The sampling device (110) according to any one of the preceding claims, wherein the pressure chamber (140) is a sealed space.

10. The sampling device (110) according to any one of the preceding claims, wherein the pressure chamber (140) is defined by a wall of the stationary component (118), by afront plate of the stationary component (118) facing the application side (128), and by a part of the movable component (120).

11. The sampling device (110) according to the preceding claim, wherein the front plate of the stationary component (118) comprises a sealing (150), wherein the sealing (150) is pierced by the penetration element (132) when the movable component (120) moves from the distal position into the proximal position.

12. The sampling device (110) according to any one of the two preceding claims, wherein the sample collection channel (138) is mounted to the front plate and protrudes, through the pressure chamber (140), into the movable component (120).

13. The sampling device (110) according to any one of the preceding claims, wherein the movable component (120) comprises a removable container adapter (116) containing the container receptacle (134), wherein the movable component (120) further comprises at least one upper movable component (124), the upper movable component (124) mounting the removable container adapter (116) to the stationary component (H8).

14. A sampling kit (112) for sampling bodily fluid, the sampling kit (112) comprising at least one sampling device (110) according to any one of the preceding claims, the sampling kit (112) further comprising at least one sample container (114) having a septum (136), the sample container (114) being receivable in the container receptacle (134) of the sampling device (110).

15. A method for generating an underpressure in a sample container (114) having a septum (136), comprising: a. receiving the sample container (114) in a container receptacle (134) of a sampling device (110) according to any one of the preceding claims referring to a sampling device (110); b. moving the movable component (120) from the distal position into the proximal position; and c. retracting the movable component (120) back from the proximal position into the distal position, wherein an underpressure generated in the pressure chamber (140) is transferred, via the pressure adjustment channel (154), into the sample container (114) through the septum (136).

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