GB2532220A

GB2532220A - Self-contained storage unit for storing body fluid

Info

Publication number: GB2532220A
Application number: GB1420058.8A
Authority: GB
Inventors: Rittmannsberger Franz; Wurm Helmut; Hafellner Reinhard
Original assignee: 4A MEDICOM GmbH
Current assignee: 4A MEDICOM GmbH
Priority date: 2014-11-11
Filing date: 2014-11-11
Publication date: 2016-05-18
Anticipated expiration: 2034-11-11
Also published as: GB2532220B; GB201420058D0

Abstract

A self-contained storage unit 100 for storing body fluid 114, e.g. blood comprises a basic body 101 with a storage cavity 107 for storing the body fluid. The body comprises a receiving section 103 for receiving a patients body part 104, for example a finger. A lancet 105 is mounted to the basic body, which lancet has a tip 106 configured for piercing the skin of the body part to enable a flow of body fluid to the storage cavity. The body also comprises an access section 109 for accessing to the body fluid inside the storage cavity, which can be lockable and unlocked by a special tool, e.g. a test device (200, figure 2). The storage cavity can contain a storage element 110, which can be a capillary element, or a strip element, e.g. a filter paper. The access section may comprise a locking mechanism operated by a key, a predefined tool, or an electric mechanism. The lancet may be storable into an isolated cavity (401, figures 6 and 7) and moved to a piercing position when pressure is applied.

Description

Self-Contained Storage Unit for Storing Body Fluid

Field of invention

The present invention relates to a self-contained storage unit for storing body fluid, a test system and a method for storing body fluid.

Art Background

Diabetes patients need a simple system of measuring glucose level several times a day. Background art of this technical field is found in DE 101 34 650, EP 2,277,442, or EP 1,486,766.

US 7,846,110 discloses a self-contained test unit for testing body fluid which comprises a body member and a support member. The support member is moveable with respect to the body member between a first position and a second position. The support member includes a body part receiving surface for receiving a patient's body part. A lancet is carried by the body member and includes a lancet tip capable of piercing the skin of a patient to produce fluid flow. A test member is capable of interacting with body fluid to aid in the determination of information about body fluid components. A capillary member is capable of guiding fluid flow to the test member. A pressure cup is capable of exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary, and a calibration member is provided for containing information for facilitating calibration of the test unit.

WO 2014/096001 discloses a test unit for testing body fluid, wherein the test unit comprises a body part receiving surface for receiving a patient's body part, a movably mounted lancet including a lancet tip configured for piercing -2 -the skin of the patient to produce flow of body fluid when the patient's body part is received at the body part receiving surface and when the lancet has been moved so that the lancet tip is in interaction with the patient's body part, and a capillary member having a first recess configured for receiving the lancet and having a second recess configured for guiding the body fluid from the body part receiving surface to a test member for interacting with the body fluid to aid in the determination of information about body fluid components, wherein the second recess has a larger surface area to volume ratio than the first recess.

However, test systems which may test the body fluid on location are basically small mobile test systems which may have not the capacity to analyse a body fluids as detailed as in large testing arrangements arranged in laboratories. Hence, there may be a need to provide a safe transportation unit from the location of taking the patient's fluid to a laboratory without contaminating the taken body fluid during transportation.

Summary of the Invention

It may be an object of the present invention to provide a storage unit for transporting a body fluid in a safe manner.

This object is solved by a self-contained storage unit for storing body fluid, by a test system and by a method for storing body fluid according to the independent claims.

According to a first aspect of the present invention, a self-contained storage unit for storing body fluid is presented. The storage unit comprises a basic body comprising a storage cavity for storing body fluid (e.g. protected against contamination from an environment of the basic body), wherein the basic body -3 -comprises a receiving section for receiving a patient's body part. Furthermore a lancet is mounted to the basic body, wherein the lancet has a lancet tip configured for piercing the skin of the body part to enable a flow of body fluid between the body part and the storage cavity of the basic body. The basic body comprises an access section for providing selectively, e.g. by the below described locking mechanism, an access to the body fluid inside the storage cavity.

According to a further aspect of the present invention a method for storing body fluid is presented. According to the method, a patient's body part (such as a tip of a finger of a patient) is received by a receiving section of a basic body of a storage unit, wherein the basic body comprises a storage cavity for storing body fluid (particularly blood) and for protecting the stored body fluid from contaminants. The skin of the body part is pierced by a lancet tip of a lancet to enable a flow of body fluid between the body part and the storage cavity of the basic body, wherein the lancet is mounted to the basic body. An access to the body fluid inside the cavity is provided by an access section. Hence, according to a further step of the method, the body fluid is removed out of the storage cavity if the locking mechanism is unlocked.

The basic body may be made of a plastic material, particularly of polycarbonate, polystyrene, polystyrene, polybutylene terephthalate, poly (methyl methacrylate, polyvinyl chloride, or polypropylene. Furthermore, such materials are compatible with injection moulding manufacturing procedures.

The basic body is designed such that the patient or a health personnel are able to grip the basic body and handle the self-contained storage unit in a comfortable manner.

The storage cavity for storing body fluid may be formed within the basic body. 30 The lancet may be made of a hard material, such as hard plastics or metal, -4 -such that the lancet may penetrate with its lancet tip the skin of a patient's body part.

The lancet may be arranged within the basic body in a lancet section. In particular, the lancet extends through the receiving section if the lancet is in a piercing position. Between the receiving section and the storage cavity, a fluid connection may be formed within the basic body. Additionally or alternatively, the lancet is configured to extend between the receiving section and the storage cavity, such that the patient's blood is guided through or along the lancet from the patient's body part via the receiving section into the storage cavity.

According to an exemplary embodiment of the present invention, the lancet is removably mounted to the basic body, in particular to the inner body as described below. The lancet may be removably fixed to the basic body for example by a click-in connection, a screw connection and/or a bayonet connection. In an exemplary embodiment, after the use of the lancet, the lancet may be simply detached from the basic body so that no unintended injuries by the used lancet are possible during transportation of the storage unit. The lancet may also be pivotably connected to the basic body, so that the lancet may be pivoted in an inactive position after the body has been pierced. As described below, the lancet may be pivoted such that the lancet and specifically the lancet tip is arranged within the lancet cavity of the inner body.

The basic body may further comprise sealing means, such as elastically deformed elements, such as rubber sealings and the like, such that a connection between the receiving section and the storage cavity is sealed and protected against contamination from the environment if the lancet is removed. For example, elastically formed sealing lips may close the opening between the receiving section and the storage cavity if the lancet is removed. -5 -

A connection between the storage cavity and the environment of the self-contained storage unit is provided by the access section. The access section may be for example an opening or a small channel or passage which is formed within the basic body between the storage cavity and the environment By covering the access section e.g. by the below described locking mechanism or the like, the access section and the storage cavity, respectively, are protected against contamination and are isolated from the environment. The atmosphere and the body fluid within the storage cavity do not have any disturbing interaction with the environment. Hence, by the locking of the access section by the locking mechanism no contaminating chemical elements, bacteria or any other contaminations can be exchanged between the storage cavity and the environment in the locked state.

Hence, by the present invention, a self-contained storage unit is presented with which it is possible to receive the blood by the lancet and to store the received body fluid within the storage cavity. Furthermore, the present storage unit can store the body fluid protected and isolated from the environment until the storage unit is transported to a location of interest, such as a laboratory.

According to conventional approaches, a body fluid which is taken from a patient's body may be stored within a conventional storage unit. For hermetically isolation, the body fluid is encapsulated and is not removable without destroying the storage unit. For example, only optical test systems which can measure and analyse the body fluid inside the storage cavity can be used. Furthermore, integral test methods, which can be processed within the storage unit itself, such as adding a reactant or a marker element within the storage unit, can be applied.

However, by the approach of the present invention, the stored body fluid can be removed out of the storage cavity for further analyses in a laboratory, for -6 -example. By providing the access section according to the present invention it is possible to remove the stored body fluid at the location of interest. Hence, the stored body fluid is not only encapsulated within the storage unit without providing a possibility to intentionally remove the body fluid.

According to a further exemplary embodiment, the storage unit further comprises a storage element for storing body fluid received from the receiving section, wherein the storage element is located inside the storage cavity. The storage element comprises for example a capillary element, a container or a strip element, in particular a filter paper. The storage element is for example configured to be removable through the access section.

The capillary element may be for example a part of the lancet itself. The container may be for example made of plastic or other suitable materials. The strip element may be made of a material which may be a kind of a blotting paper which is highly absorbent for sucking and absorbing the body fluid received from the receiving section. The blotting paper is a filter paper which may be used for dried blood spot testing (DBS). DBS is a form of biosampling where the body fluid (blood samples) are blotted and dried on the filter paper.

Dried blood spot specimens are collected by applying a few drops of blood, drawn by the lancet from the body, onto the filter paper.

Additionally, according to a further exemplary embodiment, the storage cavity comprises an additive for conservation of the body fluid, i.e. the blood, while the body fluid is stored in the cavity. The additive may be Heparin and/or EDTA (Ethylenediaminetetraacetic acid). The additive may be arranged on the storage element, such as the capillary element or the filter element.

The blood is allowed to thoroughly saturate the paper and is air dried.

Specimens are stored onto the filter paper within the storage cavity. Once in -7 -the laboratory, the filter paper is removed through the access section for analysing the specimen.

The storage element may be fixed removably within the storage cavity for example by a press fit connection. Furthermore, the storage element may be fixed within the storage cavity by a screw connection, a bayonet connection or a snap connection.

According to a further exemplary embodiment of the present invention, the basic body comprises an inner body and a cover cup. The inner body comprises the lancet, the storage cavity and the access section. The cover cup houses the inner body.

The receiving section is formed at the cover cup or the inner body. The lancet extents through the receiving section for piercing the skin of the body part.

The cover cup selectively provides the access to the access section. For example, the body fluid may be stored in the inner body. The inner body may be removed from the cover cup, such that the stored body fluid may be protected and isolated from the environment until the inner body is transported to a location of interest, such as a laboratory.

According to a further exemplary embodiment of the present invention, the cover cup comprises an access opening for selectively providing the access to the access section. The cover cup may be rotated with respect to the inner body such that the access opening is rotatable in an access position, where the access section is accessible through the access opening, or a closed position, where the cover cup covers the access opening such that no access to the access section is provided.

According to a further exemplary embodiment of the present invention, the receiving section is formed at a top surface of the cover cup, wherein the access opening is formed at the top surface besides the receiving section. -8 -

According to a further exemplary embodiment of the present invention, the receiving section is formed at a top surface of the cover cup. The cover cup comprises a lateral surface surrounding the top surface, wherein the access opening is formed in the lateral surface.

According to a further exemplary embodiment of the present invention, the cover cup comprises a cap for covering the access opening and/or for selectively covering the receiving section.

The cap may be pivotably connected to a cover cup by an integral hinge (which may be a locally thinned portion of a plastic member), the cap being configured to be selectively opened (by pivoting in a first direction) for exposing the body part receiving surface or closed (by pivoting in a second direction opposing the first direction) for covering the body part receiving surface. By covering the test unit in a default state, the inner body may remain basically protected before first use. A cap having an integral hinge connected to a body member can be manufactured by injection moulding.

According to a further exemplary embodiment of the present invention, the cover cup is removably mountable to the inner body by a screw mechanism and/or a snap fit connection.

According to a further exemplary embodiment of the present invention, the inner body comprises a lancet cavity for storing the lancet, wherein the lancet is storable inside the lancet cavity to be isolated from the environment of the basic body.

The lancet cavity may be formed within a connection channel (i.e. the below described first recess of the capillary member) close to the receiving section and the storage cavity, for example. The lancet may be attached to a guiding -9 -system formed within the basic body, such as guiding rails, wherein the lancet is guidable (e.g. together with the inner body) along the guiding system (which is a part e.g. of the cover cup) in the direction to the body part and away from the body part. An activation button or a slider may be coupled to the lancet in such a way, that a user of the storage unit may operate the button and the slider, respectively, such that an activation force is transferred by the user from the activation button and the slider, respectively, to the lancet tip, wherein by the activation force the lancet is guided to the skin of the patient's body such that the lancet tip may pierce the skin for receiving the body fluid.

According to a further exemplary embodiment of the present invention, the inner body is relatively movable along a piercing direction of the lancet with respect to the cover cup. The inner body comprises a pressure section onto which a piercing force is exertable for pushing the inner body along the piercing direction relative to the cover cup. The inner body accommodates the lancet.

Triggering a relative motion between inner body member and the cover cup may result in a movement of the lancet (e.g. along the first recess of the capillary member as described below and) relative to the receiving section for triggering the piercing.

Guiding structures may be provided in an exemplary embodiment on the cover cup and the inner body. The guide structures allow to guide the inner body relative to the cover cup parallel to the piercing direction and without the risk of tilting the lancet. Such guide structures prevent a tilting to protect the lancet from becoming stuck.

The pressure section of the inner body is configured for pressing the lancet along the piercing direction for exerting pressure on the body part to foster -10 -fluid flow out of a lanced site and into the second recess of the capillary member and hence the storage cavity.

According to a further exemplary embodiment of the present invention, the inner body is configured so that the lancet is arranged to be accommodated in an inactive state within the lancet cavity upon continued exertion of pressure onto the pressure section after the piercing. Hence, after piercing the body skin by the lancet, the inner body is further moved along the piercing direction relative to the cover cup. At a predefined relative arrangement of the inner body relative to the cover cup, the lancet is decoupled from a holding structure and arranged deactivatedly accommodated within the lancet cavity. In other words, upon continued exertion of pressure after the piercing, the lancet may be retracted towards an idle mode or an inactive position at which any subsequent forward motion of the sharp tip of the lancet towards the finger of the patient is prevented. The lancet may be for example pivotably connected to the basic body, so that the lancet may be pivoted in an inactive position after the body has been pierced. As described below, the lancet may be pivoted such that the lancet and specifically the lancet tip is arranged within the lancet cavity of the inner body. Therefore, the described mechanism can serve as a safety mechanism.

According to a further exemplary embodiment of the present invention, the receiving section comprises a capillary member which is having a first recess configured for receiving the lancet and having a second recess configured for guiding the body fluid from the body part receiving surface to the storage cavity. The second recess has a larger surface area (particularly the surface area of all walls of the capillary member delimiting the respective recess) to volume ratio (particularly the entire volume of the respective recess from its inlet juxtaposed to the body part receiving surface to its outlet) than the first recess.

The term "surface area to volume ratio" of a recess can particularly denote a value which is obtained by dividing a surface area of all walls delimiting the recess by the volume of the recess, i.e. the volume which is delimited between the inlet and the outlet of the recess. In case of an open recess which for instance has an open inlet and an open outlet, only the surface area of walls delimiting the recess are to be counted for estimating the surface area, since only the surface area of such walls contributes to surface adhesion of the body fluid in the respective recess. The expression that the second recess has a larger surface area to volume ratio than the first recess is, in technical terms, equivalent to the formulation that the capillary forces keeping the body fluid within the second recess are larger than capillary forces the body fluid would experience in the first recess. In case of an integral recess including the first recess and the second recess, the first recess is defined by the part of the integral recess within which the lancet moves. The second recess is then the remainder of the integral recess, i.e. the remaining part of the integral recess within which the lancet cannot move.

Hence, by the capillary member, a transport of the body fluid from a position of a lancet tip piercing the patient so as to produce flow of body fluid towards the storage cavity interacting with the body fluid for storing the body fluid.

This guiding of the body fluid exclusively along the desired second recess is a physical consequence of the configuration of the first and second recesses so that capillary forces keep the body fluid within and along the second recess in view of its larger surface area to volume ratio, as compared to the first recess.

By taking this measure, it is possible even for relatively unskilled users to perform a successful and reproducible test which is not disturbed or rendered impossible by an uncontrolled or undesired flow of body fluid transport along a capillary. This also holds when the volume of the body fluid (particularly blood) to be transported is very small, particularly smaller than 5 pL more particularly smaller than 500 nL.

-12 -Hence, an embodiment provides a capillary geometry for transport of body fluid to the storage cavity. In an embodiment, the transport capillary channel is designed that the body fluid is intended to flow in an edge area and not in the whole cross section (so that a smaller amount of body fluid such as blood volume is sufficient for carrying out the test). The edge is the narrower part of the channel and has edge-zones with a sufficiently small radius (for instance below 0.2 mm). The capillary geometry may be produced in an injection moulding process.

According to a further exemplary embodiment of the present invention, the storage unit is configured as a self contained disposable test unit which can only be used once. The storage unit can hence be designed as a safety product in which only a single contact of the lancet with the skin is possible. Hence, upon deactivating the lancet tip after first use, any second use of the test unit is disabled.

A locking mechanism is provided for locking and unlocking the access section such that the access to the storage cavity is selectively and unlockable such that the body fluid is removable out of the storage cavity if the locking mechanism is unlocked.

For example, the locking mechanism may comprise sealing elements and closable cover elements as described more in detail below. Specifically, the locking mechanism describes a mechanism which prevents an unintentional opening and unlocking is of the access section. Therefore, the locking mechanism may comprise for example a lock as described in further detail below, so that only by an active operation of the lock the locking mechanism unlocks the access section.

According to a further exemplary embodiment, the locking mechanism comprises a cover element (such as a removable cap) for covering the access -13 -section such that the storage cavity is sealed from the environment. The cover elements may be hinged for example to the basic body in order to be movable from a locking position to an unlocking position and vice versa. Hence, the cover element is pivotably connected to a basic body by a (integral) hinge such that the cover element is configured to be selectively pivotable (by pivoting in a first direction) in the locking position and the unlocking position for covering and opening, respectively, the access section.

For example, according to a further exemplary embodiment, the cover element is removably mountable to the basic body by a screw mechanism and/or a snap fit connection.

According to a further exemplary embodiment, the locking mechanism comprises a lock which is lockable and unlockable by a key, by a special tool and/or by electrical locking mechanism, in particular fingerprint locking devices or iris scanners.

For example, the lock may be a downholder for downholding and clamping the cover element to the basic body. The lock may be configured such that only a respective key operates the lock. Furthermore, the lock may be formed as a recess which comprises a specific inner contour, e.g. pentagon or hexagon contour, such that only a respective special tool may fit in the recess and operate the lock. Additionally, also electronic locking mechanism may be used, such as fingerprint scanners or iris scanners for operating the lock.

According to a further aspect of the present invention, a test system is presented comprising an above described storage unit and a test device for testing the body fluid. The storage unit comprises a coupling section to which the test device is coupleable. The test device comprises an unlocking element for operating the locking mechanism (if the storage unit is coupled to the test -14 -device) such that the access section is unlocked. The test device comprises a removing mechanism for removing the body fluid from the storage cavity.

The test device is for example an analysing tool for body fluids which is arranged in a laboratory. For example, the test device may be a gas chromatograph device.

The coupling section of the storage unit may be formed for forming an engagement with the respective coupling section of the test device. For example, the storage unit comprises a circular recess and the test device comprises an edge (i.e. a protrusion) which is formed for being engaged into the recess in a coupling state.

The unlocking element may be for example a respective special tool or key which may activate the above described lock, when the test device is coupled to the storage unit. In general, the unlocking element is an element which is able to unlock the locking mechanism, e.g. by opening for example the cover element of the locking mechanism, if the test device is coupled to the storage unit. Hence, an automatic unlocking of the access section is provided simply by coupling the test device to the storage unit.

Furthermore, the removing mechanism, such as an automatic gripping element, may grip the storage element for removing the storage element out of the storage cavity. However, the removing mechanism may comprise for example a further lancet which is automatically movable into the storage cavity for sucking off the stored body fluid out of the storage cavity.

Summarizing, by the above described test system, an automatic procedure for unlocking the storage unit, removing the body fluid out of the storage unit and conveying the body fluid to a location for testing reasons.

-15 -It has to be noted that embodiments of the invention have been described with reference to different subject matters. In particular, some embodiments have been described with reference to apparatus type claims whereas other embodiments have been described with reference to method type claims.

However, a person skilled in the art will gather from the above and the following description that, unless other notified, in addition to any combination of features belonging to one type of subject matter also any combination between features relating to different subject matters, in particular between features of the apparatus type claims and features of the method type claims is considered as to be disclosed with this application.

Brief Description of the Drawings

The aspects defined above and further aspects of the present invention are apparent from the examples of embodiment to be described hereinafter and are explained with reference to the examples of embodiment. The invention will be described in more detail hereinafter with reference to examples of embodiment but to which the invention is not limited.

Fig. 1 shows a schematic view of a storage unit according to an exemplary embodiment of the present invention, Fig. 2 shows a schematic view of a test system according to an exemplary embodiment of the present invention, Fig. 3 shows a perspective view of a storage unit comprising an inner body and a cover cup according to an exemplary embodiment of the present invention, -16 -Fig. 4 shows a schematic view of the storage unit comprising a lancet cavity according to an exemplary embodiment of the present invention, Fig. 5 shows a perspective view of the storage unit comprising an inner body 5 and the cover cup according to an exemplary embodiment of the present invention, Fig. 6 and Fig. 7 show schematic views of the storage unit comprising a lancet mechanism according to an exemplary embodiment of the present invention, Fig. 8 and Fig. 9 show schematic views of the storage unit comprising a further access opening and a container according to an exemplary embodiment of the present invention, and Fig. 10 shows a perspective view of a receiving section comprising a capillary member according to an exemplary embodiment of the present invention.

Detailed Description of Exemplary Embodiments

The illustrations in the drawings are schematic. It is noted that in different figures similar or identical elements are provided with the same reference signs.

Fig.1 shows an exemplary embodiment of a self-contained storage unit 100 for storing body fluid 114 of the present invention. The storage unit 100 comprises a basic body 101 comprising a storage cavity 107 for storing body fluid 114 from an environment 102 of the basic body 101, wherein the basic body 101 comprises a receiving section 103 for receiving a patient's body part 104. Furthermore a lancet 105 is mounted to the basic body 101, wherein the lancet 105 has a lancet tip 106 configured for piercing the skin of the body -17 -part 104 to enable a flow of body fluid 114 between the body part 104 and the storage cavity 107 of the basic body 101. The basic body 101 comprises an access section 109 for providing selectively, e.g. by the below described locking mechanism, an access to the body fluid 114 inside the storage cavity 107.

The locking mechanism 108 is provided for locking and unlocking the access section 109 such that the access to the storage cavity 107 is selectively lockable for being protected from contaminates from the environment and unlockable such that the body fluid 114 is removable out of the storage cavity 107 if the locking mechanism 108 is unlocked.

The storage cavity 107 is formed within the basic body 101. The lancet 105 may be arranged within a lancet cavity 401 (see Fig. 4) of the basic body 101.

In particular, the lancet 105 is arranged at the receiving section 103. Between the receiving section 103 and the storage cavity 107, a fluid connection is formed within the basic body 101. Additionally or alternatively, the lancet 105 is configured to extend between the receiving section 103 and the storage cavity 107, such that the patient's blood is guided through the lancet 105 from the patient's body part 104 via the receiving section 103 into the storage cavity 107.

The lancet 105 may be removably mounted to the basic body 101, in particular to the receiving section 103 of the basic body 101. The basic body 101 further comprises sealing means 115, such as elastically deformed elements, such as rubber sealings and the like, such that a connection between the receiving section 103 and the storage cavity 107 are sealed and protected against contaminants if the lancet 105 is removed.

A connection between the storage cavity 107 and the environment 102 of the self-contained storage unit 100 is provided by the access section 109. The -18 -access section 109 is an opening which is formed within the basic body 101 between the storage cavity 107 and the environment 102. By covering the access section 109 by the locking mechanism, the access section 109 and the storage cavity 107, respectively, are isolated from the environment 102. The locking mechanism may comprise e.g. sealing elements.

In the exemplary embodiment shown in Fig. 1, the locking mechanism comprises a cover element 111 for covering the access section 109 such that the storage cavity 107 is sealed from the environment 102. The cover element 111 is hinged to the basic body 101 in order to be movable from a locking position (see Fig. 1) to an unlocking position (see Fig. 2) and vice versa. Hence, the cover element 111 is pivotably connected to a basic body 101 by a (integral) hinge such that the cover element 111 is configured to be selectively pivotable (by pivoting in a first direction) in the locking position and the unlocking position for covering and opening, respectively, the access section 109.

Specifically, the locking mechanism is a mechanism which prevents an unintentional opening and unlocking is of the cover element 111 and hence the access section 109. The locking mechanism comprises a lock 112 so that only by an active operation of the lock 112 the locking mechanism (the cover element 111) unlocks the access section 109. Hence, the stored body fluid 114 can be removed out of the storage cavity 107 for further analyses in a laboratory, for example.

The storage unit 100 further comprises a storage element for storing body fluid 114 received from the receiving section 103, wherein the storage element is located inside the storage cavity 107. The storage element is for example a container 110. The container 110 is for example configured to be removable through the access section 109.

-19 -The storage element (i.e. the container 110) may be fixed removably within the storage cavity 107 for example by a press fit connection. Furthermore, the storage element may be fixed within the storage cavity 107 by a screw connection, a bayonet connection or a snap connection.

The locking mechanism comprises the lock 112 which is lockable and unlockable e.g. by an unlocking element 201 (see e.g. Figure 2), such as a key, by a special tool and/or by electrical locking mechanism, in particular fingerprint locking devices or iris scanners. For example, the lock 112 may be a downholder for downholding and clamping the cover element 111 to the basic body 101. The lock 112 may be configured such that only a respective key operates the lock 112.

Fig. 2 shows a test system comprising the above described storage unit 100 and a test device 200 for testing the body fluid 114. The storage unit 100 comprises a coupling section 113 to which the test device 200 is coupleable. The test device 200 comprises an unlocking element 201 for operating the locking mechanism (if the storage unit 100 is coupled to the test device 200) such that the access section 107 is unlocked. The test device 200 comprises a removing mechanism for removing the body fluid 114 from the storage cavity 107. The test device 200 is for example a test tool 203 for body fluid 114, wherein the test device is arranged in a laboratory.

The coupling section 113 of the storage unit has a coupling element 202 to form an engagement with the a respective coupling section 113 of the test device 200 For example, the storage unit 100 comprises a circular recess as coupling section 113 and the test device 200 comprises an edge (i.e. a protrusion) coupling element 202 which is formed for being engaged into the recess in a coupling state.

-20 -The unlocking element 201 may be for example a respective special tool or key which may activate the above described lock 112, when the test device 200 is coupled to the storage unit 100. In general, the unlocking element 201 is an element which is able to unlock the locking mechanism, e.g. by opening for example the cover element 111 of the locking mechanism, if the test device 100 is coupled to the storage unit 100. Hence, an automatic unlocking of the access section ee109 is provided simply by coupling the test device 100 to the storage unit 200.

A removing mechanism, such as an automatic gripping element (not shown), may grip the storage element (e.g. the container 110) for removing the storage element out of the storage cavity 107. Furthermore, the removing mechanism may comprise for example a further lancet which is automatically movable into the storage cavity 107 for sucking off the stored body fluid 114 out of the storage cavity 107.

Fig. 3 shows a perspective view of a storage unit 100 comprising an inner 302 body and a cover cup 308 according to an exemplary embodiment of the present invention.

The basic body 101 comprises an inner body 302 and a cover cup 308. The inner body 302 comprises the lancet 105, the storage cavity 107 and the access section 109. The cover cup 308 houses the inner body 302.

The receiving section 103 is formed at the inner body 302. The lancet 105 extents through the receiving section 103 for piercing the skin of the body part 100 for. The cover cup 308 selectively provides the access to the access section 109, e.g. by having an access opening 303 for selectively providing the access to the access section 109.

-21 -The locking mechanism 108 may be for example arranged within the access opening 303, such that only by unlocking the access opening 303, e.g. by a special tool, the access section 109 is accessible. Alternatively, the locking mechanism 108 may be formed by a connection system between the inner body 302 and the cover cup 308, wherein the inner body 302 is locked to the cover cup 308, wherein the cover cup 308 may only be removed from the inner body 302 by using a special tool for unlocking for example a snap fit connection.

The receiving section 103 is formed at a top surface 304 of the cover cup 308. The cover cup 308 comprises a lateral surface 305 surrounding the top surface 304, wherein the access opening 303 is formed in the lateral surface 305.

As shown in Fig. 3, a strip element 301 may be arranged within the storage cavity 107. Hence, if the lancet 105 pierces a body part 104, the body fluid, such as blood, flows to the receiving section 103 and further into the storage cavity 107, wherein the body fluid is soaked by the strip element 301 such that the body fluid is stored. The receiving section 103 may comprise a capillary member 1001 as described below in Fig. 10 in order to support the flow of the body fluid. Later on, if the body fluid is analysed, the locking mechanism 108 may unlock for example the inner body 302 from the cover cup 308, such that the strip element 301 may be removed through the access section 109 out of the storage cavity 107.

The cover cup 308 comprises a cap 306 for covering the access opening 393 and/or for selectively covering the receiving section 103.

The cap 306 may be pivotably connected to the cover cup 308 by an integral hinge (which may be a locally thinned portion of a plastic member), the cap 306 being configured to be selectively opened (by pivoting in a first direction) for exposing the body part receiving surface 103 or closed (by pivoting in a -22 -second direction opposing the first direction) for covering the body part receiving surface 103. By covering the storage unit 100 in a default state, the inner body 302 may remain basically protected before first use. The cap 306 having an integral hinge connected to a body member can be manufactured by injection moulding.

The cover cup 308 may be removably mountable to the inner body 302 by a screw mechanism and/or a snap fit connection.

Fig. 4shows a schematic view of the storage unit 100 which comprises the same features as the storage unit shown in Fig. 3. Additionally, the lancet cavity 401of the inner body 302 is shown. The lancet cavity 401 is adapted for storing the lancet 105 in such a manner that the lancet 105 is storable inside the lancet cavity 401 in order to be isolated from the environment of the basic body 101.

The lancet cavity 401 may be formed within a connection channel close to the receiving section 103 and the storage cavity 107, for example. The lancet 105 may be attached to a guiding system formed within the inner body 302, such as guiding rails, wherein the lancet 105 is guidable (e.g. together with the inner body 302) along the guiding system (e.g. of the cover cup 308) in the piercing direction 307 to the body part 104 and away from the body part 104. After the lancet 105 has pierced the body part 104, the lancet 105 is stored in the lancet cavity 401 in an inactive state. Hence, the used lancet 105 can be stored in a safe manner inside the lancet cavity 401.

Fig. 5 shows a perspective view of the storage unit 100 which comprises the same features as the storage unit 100 shown in Fig. 3. In contrast to the exemplary embodiment shown in Fig.3, the cover cup 308 comprises at its top surface 304 the receiving section 103.

-23 -Fig. 6 and Fig. 7 show schematic views of the storage unit comprising a lancet mechanism for moving the lancet 105 from an initial position (Fig. 6) into an piercing position and an inactive position (both shown in Fig. 7).

The basic body 101 comprises the cover cup 208 which houses the inner body 302. The inner body 302 is relatively movable along the piercing direction 307 of the lancet 105 with respect to the cover cup 308. The inner body 302 comprises a pressure section 601 onto which a piercing force is exertable for pushing the inner body 302 along the piercing direction 307 relative to the cover cup 308. The inner body 302 accommodates the lancet 105.

Triggering a relative motion between inner body 302 and the cover cup 308 may result in a movement of the lancet 105 (e.g. along the first recess 1002 of the capillary member 1000 as described in Fig. 10) relative to the receiving section 103 for triggering the piercing.

Guiding structures may be provided on the cover cup 308 and the inner body 302. The guide structures allow to guide the inner body 302 relative to the cover cup 308 parallel to the piercing direction 307.

The pressure section 601 of the inner body is configured for pressing the lancet 105 along the piercing direction 307 for exerting pressure on the body part 104.

The lancet 105 is pivotably hinged by a hinge 602 to the inner body 302. In an initial position, the lancet 105 is non-pivotably fixed by an e.g. fixing element comprising a predetermined breaking point. If the fixing element breaks in a predetermined position of the inner body 302 relative to the cover cup 308, the lancet 105 pivots around the hinge 602 from the initial position into an inactive state (see Fig. 7), where the lancet 105 is stored in the lancet cavity -24 - 401 and the lancet tip 106 is not in a piercing position for piercing the body part 104.

At the beginning, the lancet 105 is in an initial position as shown in Fig.6. A user may grip the cover cup 308 and presses with its finger against the pressure section 601. Hence, the press a section 601 presses and moves the lancet 105 through the receiving section 103 in a piercing position, where the lancet 105 peers the body part 1 for such that body fluid is collected within the storage cavity 107 (see Fig. 7).

The inner body 302 is further configured so that the lancet 105' is arranged to be accommodated in an inactive state within the lancet cavity 401 upon continued exertion of pressure onto the pressure section 601 after the piercing. Hence, after piercing the body skin by the lancet 105, the inner body 302 is further moved along the piercing direction 307 relative to the cover cup 308. At a predefined relative arrangement of the inner body 302 relative to the cover cup 308, the lancet 105 is decoupled from a holding structure and arranged deactivatedly accommodated within the lancet cavity 401. In other words, upon continued exertion of pressure after the piercing, the lancet 105 may be retracted towards an idle mode or an inactive position at which any subsequent forward motion of the sharp tip of the lancet towards the finger of the patient is prevented. Therefore, the described mechanism can serve as a safety mechanism.

Fig. 8 and Fig. 9 show schematic views of the storage unit 100 comprising a further access opening 801 and a container 110. The exemplary embodiment shown in Fig.8 in Fig. 9 have similar features as the exemplary embodiment shown in Fig.3.

As shown in Fig.8, additionally or alternatively, the receiving section 103 may comprise a further access opening 801. Through the further access opening -25 - 801, a storage element, such as a container 110 or the strip element 301, may be removed. Additionally, through the further access opening 801, the body fluid may be sucked out from the storage cavity e.g. by an additional needle, for example.

As shown in Fig.9, below the receiving section 103 the storage cavity 107 is formed, in which the container 110 is arranged. In the storage container 110, the body fluid is gathered. The container 110 may be integrally formed with the inner body 302, for example. The container 110 may be formed together with the inner body 302 by injection moulding, for example.

Fig. 10 shows a perspective view of a receiving section 103 of a storage unit comprising a capillary member 1001. The capillary member has a first recess 1002 configured for receiving the lancet 105 and a second recess 1003 configured for guiding the body fluid from the body part receiving surface 103 to the storage cavity 107. The second recess 1003 has a larger surface area (particularly the surface area of all walls of the capillary member 1000 delimiting the respective recess) to volume ratio (particularly the entire volume of the respective recess from its inlet juxtaposed to the body part receiving surface 103 to its outlet juxtaposed to the test member) than the first recess. The second recess 1003 is a basically triangular structure in a viewing direction perpendicular to the flow direction of the body fluid from the body part receiving surface 103 to the test storage cavity 107, particularly is a V-shaped notch. A triangle (particularly with two equal side lengths for symmetry purposes) as cross-sectional geometric form of the second recess 1003 promotes an accumulation of the body fluid in the narrow corner or edge thereof, because here the local surface area to volume ratio is very high. Thus, the second recess 1003 may have a beak-shaped appearance.

It should be noted that the term "comprising" does not exclude other elements or steps and "a" or "an" does not exclude a plurality. Also elements described -26 -in association with different embodiments may be combined. It should also be noted that reference signs in the claims should not be construed as limiting the scope of the claims.

-27 -List of reference signs: storage unit 101 basic body 102 environment 103 receiving section 104 body part lancet 106 lancet tip 107 storage cavity 108 locking mechanism 109 access section container 111 cover element 112 lock 113 coupling section 114 body fluid sealing means test device 201 unlocking element 202 coupling element 203 test tool 301 strip element 302 inner body 303 access opening 304 top surface 305 lateral surface 306 cap 307 piercing direction 308 cover cup 401 lancet cavity 601 pressure section 602 lancet hinge 801 further access opening 1001 capillary member 1002 first recess 1003 second recess

Claims

-28 -Claims 1. A self-contained storage unit (100) for storing body fluid (114), the storage unit (100) comprising a basic body (101) comprising a storage cavity (107) for storing body fluid (114), wherein the basic body (101) comprises a receiving section (103) for receiving a patient's body part (104), a lancet (105) which is mounted to the basic body (101), wherein the lancet (105) has a lancet tip (106) configured for piercing the skin of the body part (104) to enable a flow of body fluid (114) between the body part (104) and the storage cavity (107) of the basic body (101), wherein the basic body (101) comprises an access section (109) for providing selectively an access to the body fluid (114) inside the storage cavity (107).
2. Storage unit (100) according to claim 1, further comprising a storage element for storing body fluid (114) received from the receiving section (103), wherein the storage element is located inside the storage cavity (107).
3. Storage unit (100) according to claim 2, wherein the storage element comprises a capillary element, a container (110) or a strip element (301), in particular a filter paper.
4. Storage unit (100) according to claim 2 or 3, wherein the storage element is configured to be removable through the access section (109).
5. Storage unit (100) according to one of the claims 1 to 4, wherein the storage cavity comprises an additive for conservation of the body fluid while the body fluid is stored in the cavity.

-29 -
6. Storage unit (100) according to one of the claims 1 to 5, wherein the basic body comprises an inner body (302) and a cover cup (308), wherein the inner body (302) comprises the lancet (105), the storage cavity (107) and the access section (109), wherein the cover cup (308) houses the inner body (302), wherein the receiving section (103) is formed at the cover cup (308) or the inner body (302), wherein the lancet (105) extents through the receiving section (103) for piercing the skin of the body part (104), and wherein the cover cup (308) selectively provides the access to the access section (109).
7. Storage unit (100) according to claim 6, wherein the cover cup (308) comprises an access opening (303) for selectively providing the access to the access section (109).
8. Storage unit (100) according to claim 7, wherein the receiving section (103) is formed at a top surface (304) of the cover cup (308), wherein the access opening (303) is formed at the top surface (304) besides the receiving section (103).
9. Storage unit (100) according to claim 8, wherein the receiving section (103) is formed at a top surface (304) of the cover cup (308), wherein the cover cup (308) comprises a lateral surface (305) surrounding the top surface (304), wherein the access opening (303) is formed in the lateral surface (305).

-30 -
10. Storage unit (100) according to one of the claims 7 to 9, wherein the cover cup (308) comprises a cap (306) for covering the access opening (303) and/or for selectively covering the receiving section (103).
11. Storage unit (100) according to one of the claims 6 to 10, wherein the cover cup (308) is removably mountable to the inner body (302) by a screw mechanism and/or a snap fit connection.
12. Storage unit (100) according to one of the claims 6 to 11,wherein the inner body (302) comprises a lancet cavity (401) for storing the lancet (105), and wherein the lancet (105) is storable inside the lancet cavity (401) to be isolated from the environment (102) of the basic body (101).
13. Storage unit (100) according to one of the claims 6 to 12, wherein the inner body (302) is relatively movable along a piercing direction (307) of the lancet (105) with respect to the cover cup (308), wherein the inner body (302) comprises a pressure section (601) onto which an piercing force is exertable for pushing the inner body (302) along the piercing direction (307) relative to the cover cup (308).
14. Storage unit (100) according to claim 13, wherein the inner body (302) is configured so that the lancet (105) is arranged to be accommodated in an inactive state within the lancet cavity (401) upon continued exertion of pressure onto the pressure section (601) after the piercing.
15. Storage unit (100) according to one of the claims 6 to 14, wherein the lancet (105) is pivotably hinged by a hinge (602) to the inner body (302) in such a manner that, in an initial position, the lancet (105) is non-pivotably fixed and, in a predetermined position of the inner body (302) -31 -relative to the cover cup (308), the lancet (105) pivots by the hinge (602) from the initial position into an inactive state.
16. Storage unit (100) according to one of the claims 1 to 15, wherein the receiving section (103) comprises a capillary member (1001) which is having a first recess (1002) configured for receiving the lancet (103) and having a second recess (1003) configured for guiding the body fluid from the body part receiving surface (103) to the storage cavity (107), wherein the second recess (1003) has a larger surface area to volume ratio than the first recess (1002).
17. Storage unit (100) according to one of the claims 1 to 16, wherein the storage unit (100) is configured as a self contained disposable test unit (100) which can only be used once.
18. Storage unit (100) according to one of the claims 1 to 17, further comprising a locking mechanism (108) for locking and unlocking the access section (109), wherein the locking mechanism (108) is coupled to the basic body (101) such that the access to the storage cavity (107) is selectively lockable and unlockable such that the body fluid (114) is removable out of the storage cavity (107) if the locking mechanism (108) is unlocked.
19. Storage unit (100) according to claim 18, wherein the locking mechanism is formed within the access section (109) such that only a predefined tool is guidable through the access section (109) for providing an access to the storage cavity (107).

-32 -
20. Storage unit (100) according to claim 18 or 19, wherein the locking mechanism (108) comprises a lock (111) which is lockable and unlockable by a key, by a special tool and/or by electrical locking mechanism (108), in particular fingerprint locking devices or iris scanners.
21. Test system, the test system comprising a storage unit (100) according to one of the claims 1 to 20, a test device (200) for testing the body fluid (114), wherein the storage unit (100) comprises a coupling section (111) to which the test device (200) is coupleaple, wherein the test device (200) comprises an unlocking element (201) for operating the locking mechanism (108), such that the access section (109) is unlocked, wherein the test device (200) comprises a removing mechanism for removing the body fluid (114) from the storage cavity (107).
22. Method for storing body fluid (114), the method comprising receiving a patient's body part (104) by a receiving section (103) of a basic body (101) of a storage unit (100), wherein the basic body (101) comprises a storage cavity (107), piercing the skin of the body part (104) by a lancet tip (106) of a lancet (105) to enable a flow of body fluid (114) between the body part (104) and the storage cavity (107) of the basic body (101), wherein the lancet (105) is mounted to the basic body (101), providing a selective access to the body fluid (114) inside the cavity by an access section (109).