Solid-body separator for separating at least two constituents of a bodily liquid

Abstract

The invention relates to a solid-body separator for separating at least two constituents (2, 3) of a bodily liquid (4), wherein a first constituent (2) of the bodily liquid (4) has a first density and a second constituent (3) of the bodily liquid (4) has a second density, wherein an overall density of the solid-body separator (1) lies between the first density and second density of the constituents (2, 3) of the bodily liquid (4) that are to be separated, comprising – at least one ballast body (10), - at least one float (9), - wherein the ballast body (10) and the float (9) are movable relative to each other, in particular when a centrifugal force acts on the solid-body separator (1), - wherein the solid-body separator (1) has at least one elastically deformable connection element (33) which forms a force-transmitting connection between the float (9) and the ballast body (10), such that - proceeding from a state of rest - for a relative movement between float (9) and ballast body (10), a force is required for overcoming a restoring force defined by the connection element (33), - wherein the connection element (33) overlaps the ballast body (10) or the float (9) in at least one overlap region (35). To make available a solid-body separator (1) that overcomes the problems of the prior art and is distinguished by particularly reliable transfer of the solid-body separator (1) to a state of rest, provision is made according to the invention that the connection element (33) at at least one anchoring location (38) is connected to the ballast body (10) or float (9) in such a way that, during a relative movement, in particular caused by a centrifugal force acting on the solid-body separator (1) floating in the bodily liquid (4), the connection element (33) is prevented from deforming in at least a portion of the overlap region (35).

Description

Solid state separator for separating at least two components of a body fluid Description

[0001] The present application relates to a solid-state separator for separating at least two components of a body fluid. A first component of the body fluid has a first density, while a second component of the body fluid has a second density. The total density of the solid-state separator lies between the first and second densities of the components to be separated. The solid-state separator comprises at least one ballast body and at least one floating body. The ballast body and the floating body are movable relative to one another, particularly when a centrifugal force acts on the solid-state separator.

[0002] Furthermore, the solid-state separator has at least one elastically deformable connecting element. The connecting element forms a force-transmitting connection between the floating body and the ballast body. In this way, starting from a rest state of the solid-state separator, a force is required for a relative movement between the floating body and the ballast body to overcome a restoring force defined by the connecting element. The connecting element overlaps the ballast body or the floating body in at least one overlapping area. An “overlapping area” within the meaning of the present application is understood to be an area in which the connecting element overlaps the ballast body, i.e. is arranged parallel to and separate from the ballast body. The connecting element can in particular be embedded in the ballast body or floating body. In this case, the ballast body or the floating body has a recess or groove.The connecting element can also rest on the ballast body or float and protrude beyond a surface of the ballast body or float. A combination of the two aforementioned variants is also conceivable.

[0003] Solid-state separators are used to separate the components of a body fluid from one another. A first component of the body fluid has a first density and a second component of the body fluid has a second density. The body fluid can be blood, in particular, with the components to be separated being blood serum, blood plasma, and the buffy coat. Likewise, any other body fluid can be separated into its components and maintained in a separate state using the solid-state separator. For example, the solid-state separator can be used to Separation of urine, saliva, amniotic fluid and intestinal fluid into their respective components.

[0004] The solid-state separator typically comprises a first material and a second material, wherein the two materials are present separately from one another in the solid-state separator.

[0005] To separate the components of body fluids, a solid-state separator is generally used in conjunction with a centrifuge. The solid-state separator is placed in a sample container, typically a tube, along with a body fluid, and then centrifuged. As a result of the centrifugal force acting on the body fluid and the different densities of the two components of the body fluid, the components separate from each other. Since this state only lasts as long as the centrifugal force acts on the body fluid, the solid-state separator is required. The target overall density of the solid-state separator lies between the densities of the two components, so that the solid-state separator positions itself between the two components during centrifugation.The solid-state separator is typically designed to allow for exchange of components during the centrifugation process, but to prevent this exchange if the centrifugal force is removed. This ensures that the components of the body fluid remain separated from one another in the sample container even after the centrifugation process, i.e., after the centrifugal force is removed. State of the art

[0006] A large number of solid-state separators are known from the prior art. As an example, reference is made to the solid-state separator described in EP 3 778 027 A1. The solid-state separator described therein comprises a ballast body and a floating body which are connected to one another by means of an elastically deformable connecting element. The floating body has a through-opening, and the ballast body has a pin which can be inserted into the through-opening, wherein the through-opening together with the pin forms a valve. When the solid-state separator is at rest, the pin is inserted into the through-opening. The connecting element overlaps the ballast body in an overlap region. For this purpose, the ballast body has four grooves into which the connecting element, which comprises four retaining brackets inserted into the grooves, is embedded.When subjected to centrifugal force, the ballast body moves away from the floating body due to its greater density. In the process, the pin is removed from the The through-hole is removed and released, allowing the components to flow through. The elastically deformable connecting element ensures that the pin of the ballast body moves back into the through-hole once the centrifugal force is removed, thus permanently separating the components from one another.

[0007] However, it has proven problematic with the known solid-state separator that the connecting element deforms unevenly when subjected to a force, particularly a centrifugal force. This prevents it from being ensured that the ballast body will be safely inserted into the through-hole after the centrifugal force is removed, thus preventing renewed mixing of the previously separated components. The uneven deformation of the connecting element in the overlap area is primarily due to friction in the retaining bracket areas of the connecting element in the area of ​​the grooves. Task

[0008] The object of the present invention is therefore to provide a solid-state separator which eliminates the existing problems and is characterized by a particularly safe transfer of the solid-state separator into a rest state. Solution

[0009] Based on the method mentioned at the outset, the above object is achieved in that the connecting element is connected to the ballast body or floating body in at least one anchoring point in such a way that in the event of a relative movement, in particular as a result of the action of a centrifugal force on the solid-state separator floating in the body fluid, the connecting element is prevented from deforming in at least one section of the overlapping area.

[0010] The connection of the connecting element to the ballast body or the floating body advantageously ensures that the connecting element cannot deform in the overlap area. This ensures that the solid-state separator can be safely returned to its rest position after removal. In particular, uncertainties regarding a safe transfer of the solid-state separator to its rest position due to uneven deformation of the connecting element can be avoided. The prevented deformation of the connecting element is achieved by the connection of the connecting element to the ballast body or the floating body in the anchoring point.

[0011] Preferably, it can be provided that the connecting element is divided into two regions: in a first region, deformation of the connecting element is possible in order to enable relative movement between the floating body and the ballast body and at the same time to ensure that the solid-state separator can be returned to its rest position, in particular after the centrifugal force has ceased. This is particularly necessary when separation of the components is only possible by opening a through-opening in the solid-state separator, which is then opened when the ballast body and the floating body move away from each other. The first region can preferably be in the form of at least one tab-shaped section. A second region of the connecting element is not deformed even when the centrifugal force is applied.The second region can be provided, in particular, to hold the ballast body to the floating body during the action of centrifugal force. The second region can preferably be designed in the form of at least one retaining bracket. Advantageously, the two regions of the connecting element thus ensure that the ballast body and the floating body can move relative to each other, but cannot completely separate from each other, while simultaneously ensuring that the connecting element does not deform adversely in the overlap region, thus leading to an unsafe transfer of the solid-state separator to the rest position.

[0012] The design of the two regions of the connecting element can be implemented, for example, through different material thicknesses. While the first region is particularly thin, the second region can be particularly thick, so that the force required to deform this region is higher than the force required to deform the first region. Furthermore, the contact area between the first and second regions can be as small as possible. The contact area is preferably limited to the size necessary to connect the two regions. From a mechanical point of view, the two regions can thus act as two interconnected springs with different spring constants that are connected in series. This can ensure that the connecting element does not deform in the overlapping region.This can be achieved by assigning a higher spring constant to the second region acting as a spring than to the first region acting as a spring. In this case, the overlap region can preferably be assigned to the second region of the connecting element.

[0013] According to a preferred embodiment of the invention, the ballast body is connected to the floating body by means of a frictional connection or a positive connection. In any case, however, it must be prevented that the ballast body can completely separate from the floating body. Preferably, the floating body and the connecting element of the solid-state separator are connected to one another in a positive-locking manner, with the connecting element overlapping the ballast body in the overlapping area.

[0014] According to a preferred embodiment of the invention, the connecting element has at least one tab-shaped section. In the context of the present application, “tab-shaped” is understood to mean a shape which has a particularly small thickness compared to a width and height and can therefore be deformed particularly easily. In this case, it can preferably be provided that the connecting element is made of a plastic, in particular a thermoplastic elastomer. The advantage of a tab-shaped design of the connecting element is that, on the one hand, a connection can be created between the floating body and the ballast body and, on the other hand, a particularly low material expenditure is required. In this case, it can preferably be provided that the connecting element is oriented in such a way that the connecting element deforms along a width side or a height side if a force acts on it.In a particularly preferred manner, the connecting element deforms while reducing the thickness of the connecting element.

[0015] According to a preferred embodiment of the invention, the connecting element is formed essentially from the same material as the floating body. The ballast body can be formed from a different material to achieve different densities. In particular, it can be provided that the connecting element is formed integrally with the floating body, so that the floating body and the connecting element form a single component, while the ballast body forms a second component.

[0016] For the purposes of this application, a "component" is understood to mean a part of the solid-state separator. The component does not necessarily have to be separate from another component or other elements of the solid-state separator. Rather, the component can also be integrally connected to other components and / or elements of the solid-state separator.

[0017] The above embodiment is particularly advantageous with regard to the manufacture of the solid-state separator, since in this way preferably only two components have to be manufactured in order to form the solid-state separator.

[0018] An advantageous embodiment of the invention provides that the connecting element is connected to the ballast body or the floating body by means of at least one anchoring element, preferably acting due to a positive connection, wherein the anchoring element is preferably designed in the form of a web or a pin. The function of the connecting element is to enable movement between the floating body and the ballast body. At the same time, it should be ensured that the ballast body and the floating body cannot move completely away from each other and that the ballast body can be returned to a rest position after the removal of a force acting on it, in particular a centrifugal force. It has proven particularly advantageous to provide a positive connection between the ballast body and the floating body, which is made possible by the anchoring element.For example, it can be provided that the ballast body has the anchoring element in the form of a web, while the connecting element is formed integrally with the floating body, wherein the anchoring element is positively connected to the connecting element, for example, is enclosed by it. This creates a particularly secure connection between the floating body and the ballast body.

[0019] A further preferred embodiment of the invention provides that the floating body and / or the ballast body has at least one groove in the overlapping area.

[0020] Preferably, at least one retaining bracket can be assigned to the connecting element, which at least partially encompasses the floating body or the ballast body. The retaining bracket is preferably made of the same material as the connecting element and more preferably as the floating body. In a particularly preferred embodiment, the floating body, the connecting element and the at least one retaining bracket assigned to it are formed integrally from the same first material, while the ballast body is formed as a separate component from a second material whose density differs from that of the first material. The retaining bracket holds the ballast body enclosed, so that even when a force is applied, complete removal of the ballast body from the floating body is prevented. Preferably, a plurality of retaining brackets can also be provided, so that the security of holding the floating body or the ballast body is improved.

[0021] A further embodiment of the invention provides that the connecting element has four tab-shaped sections and four retaining brackets associated with the tab-shaped sections, wherein the tab-shaped sections and the associated retaining brackets are preferably arranged at an angle of 90° to each other. When a force acts on the ballast body or the floating body, the force can thus be evenly distributed across the four tab-shaped sections or retaining brackets. Furthermore, material stress is reduced and safety is increased.

[0022] Furthermore, it is particularly advantageous if the retaining brackets converge at one end of the solid-state separator. The retaining brackets can form a kind of "basket" in which the ballast body or float can be held. This ensures the ballast body or float is securely held.

[0023] An advantageous embodiment of the invention provides that the floating body has a sealing region, wherein the sealing region is materially connected to the holding bracket by means of the connecting element. The sealing region serves to enable the solid-state separator to be inserted in a sample container in a sealing manner. In particular, it can be provided that the sealing region is brought into sealing contact with a wall of the sample container. This is intended, in particular, to prevent the components separated from one another after a centrifugation process from mixing with one another again. In particular, it can be provided that the sealing region is formed integrally with the connecting element and the holding bracket, wherein the connecting element connects the sealing region to the holding bracket.

[0024] According to a further preferred embodiment of the invention, it is provided that a cross-sectional area of ​​the retaining bracket exceeds a cross-sectional area of ​​the tab-shaped section. The retaining bracket serves to at least partially encompass the floating body or the ballast body. In order to ensure a possible secure hold, the cross-sectional area of ​​the retaining bracket should be dimensioned such that a hold can be ensured. The tab-shaped section of the connecting element, on the other hand, only serves to form a force-transmitting connection between the floating body and the ballast body. The connecting element must primarily be elastically deformable in the tab-shaped section. The cross-sectional area of ​​the tab-shaped section of the connecting element can be selected as desired, as long as the aforementioned function is fulfilled. The combination of a cross-sectional area that is larger than the cross-sectional area of ​​the tab-shaped The enlarged cross-sectional area of ​​the retaining bracket has therefore proven to be particularly advantageous for the reasons stated above.

[0025] Furthermore, a further preferred embodiment of the invention provides that the ballast body has a first section and a second section, wherein the first section is preferably hemispherical and the second region is preferably peg-shaped. Preferably, it can be provided that the peg-shaped region is arranged on an upper side of the hemispherical region. Furthermore, it can be particularly advantageous if the floating body has a through-opening into which the second section of the ballast body can be inserted to form a valve. In other words, the floating body and the ballast body together form a valve in which the peg of the ballast body can be inserted into the through-opening to seal the through-opening of the floating body.When the solid-state separator is in the rest position, the pin is inserted into the through-opening in such a way that the body fluid is prevented from flowing through the through-opening. The pin is held in the through-opening by the connecting element. When a force acts on the solid-state separator, in particular a centrifugal force, the ballast body moves away from the floating body due to its density. In the process, the pin is moved out of the through-opening and releases it, so that the body fluid, in particular certain components of the body fluid, can flow through the through-opening. If the solid-state separator has a sealing area, it can be provided that the components are only exchanged through the through-opening. The connecting element ensures that the ballast body does not move completely away from the floating body.When the force is removed, the connecting element, due to its elastic deformability, causes the pin of the ballast body to be inserted into the through-hole and thus permanently separates the separated components of the body fluid from each other, ie even after the force is removed.

[0026] A further embodiment of the invention provides that the first section of the ballast body has the overlapping region, wherein the overlapping region is designed in the form of at least one groove that at least partially surrounds the first section of the ballast body. According to a preferred embodiment of the inventors, it is further provided that the retaining bracket runs in the groove of the ballast body. The result is that the floating body, which in this case is connected to the connecting element, is connected to the ballast body. In this configuration, it can be provided that the connecting element is located in a groove connecting the floating body and the ballast body. Area deforms under the action of the force, while deformation in the overlap area is prevented. In other words, the retaining brackets assigned to the connecting element do not deform, so that the retaining brackets hold the ballast body, whereby a force exerted by the retaining brackets on the ballast body is independent of an external force acting on the solid-state separator. In this way, it can be advantageously prevented that the connecting element deforms unevenly due to friction of the retaining brackets in the groove, which would lead to incomplete closure of the through-opening and thus to unwanted mixing of the separated components of the body fluid.

[0027] According to a further preferred embodiment of the invention, the connecting element is deformable during a relative movement between the floating body and the ballast body, in particular as a result of a centrifugal force acting on the solid-state separator, such that contact between the connecting element and the first section of the ballast body outside the anchoring point can be temporarily and at least partially eliminated. In other words, the connecting element detaches from the ballast body outside the anchoring point. In this way, the connecting element is stretched, in particular in the region of the anchoring point, if a force acts on the solid-state separator that causes the ballast body to move. Once the force is removed, the elastically deformable connecting element causes contact between the connecting element and the first section of the ballast body outside the anchoring point to be re-established. Examples of implementation

[0028] The invention is explained in more detail below using an exemplary embodiment illustrated in the figures. It shows: Fig. 1: A vertical section through a sample container, wherein a solid state separator according to the invention is in an initial position in the sample container. Fig. 2: A perspective view of a floating body of the Solid state separator from Figure 1. Fig. 3: A perspective view of a ballast body of the inventive Solid state separator from Figure 1. Fig. 4: Another perspective view of the ballast body from Figure 3 in a vertical section. Fig. 5: A perspective view of the solid-state separator from Figure 1. Fig. 6: A vertical section through the solid-state separator from Figure 1. Fig. 7: As in Figure 6, with a centrifugal force acting on the solid separator. Fig. 8: A horizontal section through a sample container, where the Solid state separator from Figure 1 is in an initial position in the sample container. Fig. 9: As Figure 1, showing different stages of movement of the Solid state separator are shown. Fig. 10: A detailed view of the solid state separator during a Centrifugation process. Fig. 11 : The sample container with the solid state separator from Figure 1 in a Final state of the solid separator after the centrifugation process. Fig. 12: The ballast body of the solid state separator from Figure 1 during a manufacturing process. Fig. 13: The solid-state separator from Figure 1 during a manufacturing process. Fig. 14: Another view of the solid state separator from Figure 1 during a manufacturing process. Fig. 15: Another solid state separator according to the invention during a manufacturing process.

[0029] A solid-state separator 1 according to the invention is shown in Figures 1 to 15. The solid-state separator 1 serves to separate components 2, 3 of a body fluid 4 with different densities from one another during a centrifugation process. The centrifugation process is an essential component in the pre-analytics of blood 11 for medical purposes. For this purpose, the blood 11 is taken from a patient and introduced into a sample container 19 in the form of a blood collection tube 20. As can be seen from Figure 1, the solid-state separator 1 is already located in the blood collection tube 20, having previously been inserted into the blood collection tube 20. By means of the centrifugation process, the blood 11 is to be separated into its components 2, 3, namely blood plasma 12, blood serum 13 and a leukocyte film (“buffy coat”), whereby the aforementioned components 2, 3 of the blood 11 have different densities.

[0030] The solid-state separator 1 has two relatively movable, interconnected components 7, 8: a floating body 9 and a ballast body 10. The Floating body 9 is shown in Figure 2, and ballast body 10 in Figures 3 and 4. An assembled state of solid-state separator 1 is shown in Figures 5 to 7. Ballast body 10 is formed from a first material 5, while float 9 is formed from a second material 6. Both components 7, 8 are made of plastic. The first material 5 forming ballast body 10 has a first density p1 that is greater than a density p2 of the second material forming float 9. The second density p2 is less than the density of blood serum 13, and the first density p1 is greater than the density of blood plasma 12. The total density p of solid-state separator 1 lies between the density of blood plasma 12 and the density of blood serum 13.

[0031] Furthermore, the second material 6 is soft and supple and exhibits recovery properties. The first material 5, on the other hand, has no recovery properties and is designed without elastic properties.

[0032] The ballast body 10 has a first, substantially hemispherical section 21 and a second section 22, the latter being in the form of a pin 15. The first section 21 of the ballast body 10 is provided with four grooves 23, which are arranged at an angle of 90° to one another. On an upper side, the first section 21 is provided with four connecting elements 24 in the form of webs 25. The webs 25 connect the areas of the first section 21 of the ballast body 10 that do not have a groove 23. The pin 15 of the ballast body 10 is—as can be seen from Figure 4—hollow and has an inner pin 17 projecting into a cavity 27. A length 18 of the inner pin 17 is reduced compared to a length 26 of the cavity 27 of the pin 15, as can be seen in particular from Figure 6.

[0033] The floating body 9 is shaped like a funnel and has a sealing region 28 at its upper end. A circumferential sealing edge 29 is formed on the sealing region 28 for a circumferentially sealing engagement with an inner side of the blood collection tube 20. An outer diameter 30 of the sealing edge 29 is larger than an inner diameter 31 of the blood collection tube 20, so that the solid-state separator 1, when in an initial position, which is shown in particular in Figure 1, is held in the blood collection tube 20 due to static friction of the sealing edge 29 against the wall 52. Furthermore, the floating body 9 has a through-opening 16 that extends through the floating body 9 along a longitudinal axis 32 of the floating body 9.

[0034] The through-opening 16 of the floating body 9 and the pin 15 of the ballast body 10 together form a valve 14 for opening or closing the Through-opening 16 in the floating body s. In a resting state of the solid-state separator 1, which is shown in Figure 5, the pin 15 of the ballast body 10 is inserted into the through-opening 16 of the floating body 9 and closes it in a liquid-tight manner.

[0035] However, the floating body 9 and the ballast body 10 are movable relative to one another. When the centrifugal force acts on the solid-state separator 1, the ballast body 10 experiences a greater force than the floating body 9, so that the ballast body 10 moves relative to the floating body 9. In the process, the pin 15 is moved out of the through-opening 16. To prevent the two components 7, 8 from completely separating from one another and to ensure that the valve 14 closes automatically again when the centrifugal force ceases, the floating body 9 of the solid-state separator 1 has a connecting element 33. The connecting element 33 has four tab-shaped sections 48, which are formed from the second material 6 and are each arranged at an angle of 90° to one another on an underside 29 of the floating body 9.The tab-shaped sections 48 are elastically deformable and establish a force-transmitting connection between the floating body 9 and the ballast body 10, so that—starting from a resting state of the solid-state separator 1—a relative movement between the floating body 9 and the ballast body 10 requires a force to overcome a restoring force defined by the connecting element 33. This force is provided by the action of the centrifugal force on the solid-state separator 1.

[0036] Furthermore, the connecting element 33 overlaps the ballast body 10 in an overlap region 35. In the overlap region 35, the solid-state separator 1 has grooves 23 in the first section 21 of the ballast body 10. Furthermore, the connecting element 33 has four retaining brackets 36 that encompass the ballast body 10. The grooves 23 serve to accommodate the retaining brackets 36. The retaining brackets 36 converge on an underside 51 of the solid-state separator 10. The retaining brackets 36 are also formed from the second material 6.

[0037] The connecting element 33 is also connected to the ballast body 10 at four anchoring points 38 by means of four anchoring elements 24 in such a way that, in the event of a relative movement, in particular as a result of the action of a centrifugal force on the solid-state separator 1, the respective retaining bracket 36 of the connecting element 33 is prevented from deforming in the overlapping area 35. The webs 25 in the ballast body 10 serve as anchoring elements 24. The webs 25 are, on the one hand, positively connected to the retaining brackets 36 and, on the other hand, to the tab-shaped Sections 48 of the connecting element 33 outside the overlap area 35.

[0038] The floating body 9 and the connecting element 33 are made of the same material and are formed as a single piece. The tab-shaped sections 48 of the connecting element 33 connect the retaining brackets 36 as a single piece to the sealing region 28 of the solid-state separator 1, as is particularly clearly visible in Figure 2. It is also evident that a cross-sectional area of ​​the retaining brackets 36 exceeds a cross-sectional area of ​​the tab-shaped sections 48 of the connecting element 33. In other words, the retaining brackets 36 are thicker than the tab-shaped sections 48 of the connecting element 33. The two regions of the connecting element 33, i.e. the retaining brackets 36 and the tab-shaped sections 48, are thus connected to one another in a contact region 55.The contact area 55 in the region of the anchoring points 38 between the retaining brackets 36 and the tab-shaped sections 48 is, however, small, as can be seen, for example, in Figure 6. The contact area 55 is composed of two sections, each adjacent to the respective web 25. The retaining brackets 36 and the tab-shaped sections 48 thus act, from a mechanical point of view, as two springs connected in series with different spring constants. A spring constant attributable to the retaining brackets 36 is greater than a spring constant attributable to the tab-shaped sections 48, which means that when a force is applied, only the tab-shaped sections 48 and not the retaining brackets 36 are deformed.

[0039] The solid-state separator 1 under the influence of a centrifugal force is shown in Figure 7. During the centrifugation process, the centrifugal force causes the ballast body 10 to separate from the floating body 9. The connecting element 33 ensures that the ballast body 10 does not completely separate from the floating body 9. In this case, the connecting element 33 is elastically deformed in the area outside the overlap area 35, namely in the area of ​​the tab-shaped section 48. The retaining brackets 36, however, are not deformed due to the connection of the connecting element 33 via the anchoring elements 24, the small contact area 55 to the tab-shaped sections 48, and the associated spring constant.

[0040] At the same time, however, the ballast body 10 is moved away from the floating body 9 in such a way that contact between the tab-shaped sections 48 of the connecting element 33 and the first section 21 of the ballast body 10 outside the anchoring point 38 during the duration of the centrifugation process is eliminated, as can be seen in particular from Figure 7. The contact between the tab-shaped sections 48 of the connecting element 33 and the anchoring elements 24 is also at least partially eliminated on one side. However, due to the one-piece connection between the tab-shaped sections 48 of the connecting element 33 and the retaining brackets 36 of the connecting element 33, these remain in contact even under the action of centrifugal force.

[0041] The sealing area 28 of the floating body 9 is squeezed upon insertion into the blood collection tube 20 such that the solid-state separator 1 can be accommodated in the blood collection tube 20. For this purpose, the solid-state separator 1 is rotated with its longitudinal axis 39 by 90° relative to an initial position shown in Figures 2 to 7, so that the longitudinal axis 39 of the solid-state separator 1 is aligned perpendicular to a longitudinal axis 40 of the blood collection tube 20. An inserted state of the solid-state separator 1 is shown in Figure 8. After inserting the solid-state separator 1 into the blood collection tube 20, the patient's blood 11 can be poured into the blood collection tube 20. The blood collection tube 20 with the solid-state separator 1 is then inserted into a centrifuge (not shown in the figures) and centrifuged. A direction of rotation 53 in which the blood collection tube 20 is rotated is shown in Figure 9.

[0042] Due to a centrifugal force acting on the solid-state separator 1, the solid-state separator 1 overcomes the static friction. The solid-state separator 1 moves toward a bottom 41 of the blood collection tube 20 and rotates in the process, as the centrifugal force acts more strongly on the ballast body 10 due to the increased density of the ballast body 10 compared to the density of the floating body 9. The solid-state separator 1 aligns itself such that the longitudinal axis 39 of the solid-state separator 1 is parallel to the longitudinal axis 40 of the blood collection tube 20. In this state, the sealing edge 29 lies sealingly against the inside of the blood collection tube 20.

[0043] At the same time, during centrifugation, the components 2, 3 of the body fluid 4 to be separated are also separated from one another due to differences in density. The separation of the components 2, 3 is made possible by the presence of the through-opening 16 in the floating body 9. During centrifugation, the pin 15 of the ballast body 10 is moved out of the through-opening 16, thus opening a flow path 42 for the components 2, 3 of the blood 11, as can be seen particularly in Figure 10. In this way, the components 2, 3 can be arranged above and below the solid-state separator 1 depending on their density.

[0044] Since the total density pcesamt of the solid separator 1 lies between a density of the first component 2 and a density of the second component 3 of the body fluid 4, the solid separator 1 is arranged at a boundary 43 between the two components 2, 3 after the separation of the two components 2, 3, as can be seen from Figure 10. The total density pcesamt of the solid separator 1 is preferably selected such that a lowest point of the through-opening 16 of the solid separator 1 is arranged above the boundary 43 between the two components 2, 3. For example, it can be provided that a distance between the lowest point and the boundary 43 is approximately 1 mm. In this way, on the one hand, a safety distance can be selected which prevents the second component 3 from arranging itself above the solid separator 1 when the centrifugal force decreases.At the same time, the distance is chosen to be as small as possible so that a loss of sample material, in particular of component 2, is minimized when component 2 is poured out of the blood collection tube 20 after the centrifugation process has ended.

[0045] The various stages of the solid-state separator 1 during its movement are shown in Figure 9. After the centrifugal force ceases due to the termination of the centrifugation process, the connecting element 33 closes the valve 14. The pin 15 of the ballast body 10 is reinserted into the through-opening 16. In this way, the components 2, 3 of the body fluid 4 remain separated from each other even after the centrifugal force ceases.

[0046] The restoring force of the tab-shaped sections 48 of the connecting element 33 is selected such that the pin 15 of the ballast body 10 is inserted back into the through-opening 16 as soon as the centrifugal force decreases, and does not move back into the through-opening 16 until the centrifugal force is completely eliminated. Such a state is shown in Figure 7.

[0047] The fact that the solid separator 1 arranges itself at the boundary 43 between the components 2, 3 even in the case of fluctuations in the density pi, p2 of the two materials used is ensured during the manufacture of the solid separator 1.

[0048] The total density pcesamt of the solid separator 1 is calculated as follows:

[0049] Due to fluctuations in the density pi of the first material 5 and / or the density p2 of the second material 6, a deviation of the value of the total density pcesamt of the solid-state separator 1 from a target value of the total density pcesamt of the solid-state separator 1 required for optimal separation of the components 2, 3 of the blood 11 may occur. To avoid this, the densities pi, p2 of the two materials 5, 6 are determined in a first step and compared with the respective target densities. The target densities are the densities that the materials 5, 6 must have so that the value of the total density pcesamt of the solid-state separator 1 is optimally adjusted. Depending on the material 5, 6 whose density pi, p2 deviates from the target density, the volume Vi, V2 of the first material 5 and / or the second material 6 used is adjusted.The adjustment of the volume Vi, V2 is carried out, for example, by an extension or shortening of the inner pin 17 of the pin 15 of the ballast body 10 of the solid-state separator 1, as shown in Figure 12.

[0050] If the density pi of the first material 5 forming the ballast body 10 is reduced compared to the target density, the value of the total density pcesamt can be adjusted by lengthening the inner pin 17. Conversely, the value of the total density pcesamt can be adjusted by shortening the inner pin 17 if the density pi of the first material 5 is increased compared to the target density. The volume V1 of the first material 5 used to form the solid-state separator 1 can be determined as follows:

[0051] The solid-state separator 1 is manufactured using the injection molding process, as shown in Figure 13. In a first process step, the first material 5 is injected into a first mold 55, and a first component 7 is formed. The first component 7 later forms the ballast body 10 of the solid-state separator 1. The inner pin 17 and a wall of the pin 15 do not touch, so that a cavity 44 is formed in the pin 17. Furthermore, the pin 15 is provided on an upper side with an annular recess 49 - as can be clearly seen in particular from Figure 4 - wherein the recess 49 is closed at three connection points 50 between the inner pin 17 and the pin 15.

[0052] After the first material 5 has hardened, the molding tool 55 is transferred from a first molding position to a second molding position. An interior space enclosed by the molding tool 55 in the second molding position essentially corresponds to a final shape of the solid-state separator 1. Finally, in a second process step, the second material 6 is introduced into the molding tool 55 through the annular recess 49 of the ballast body 10, without forming a material bond with the first material 5 or the first component 7 formed therefrom. As shown in Figures 14 and 15, the second material 6 flows from the annular recess 49 on the upper side 45 of the first component 7 through the cavity 44 in the pin 15 to a lower side 46 of the first component 7.The underside 46 forms a reversal region 47, from which the second material 6 flows around an outer side of the first component 7 up to a top side 45 of the first component 7. In a final state, the second material 6 completely fills the cavity 44 that existed in the pin 15 of the first component 7. The second material 6 is finally also cured. After the second material 6 has cured, the two components 7, 8 are movable relative to one another, whereby complete removal of the floating body 9 from the ballast body 10 is prevented due to the force-locking connection of the connecting element 33 in the anchoring points 38.

[0053] In order to be able to adjust a length 18 of the inner pin 17 during the manufacturing process and thus change a volume of the first component 7, a further tool 54 can be used, which is inserted before the first material 5 is introduced into the molding tool 55, as can be seen in particular from Figure 12. The tool 54 limits a flow of the first material 5 in the direction of an underside 34 of the floating body 9. In this way, the inner pin 17 can be adjusted in its length 18. After curing and insertion of the first component 7 into the second molding tool 55 or after transferring the first molding tool 55 into the second molding position, the tool 54 can be removed.

[0054] The solid-state separator 1 produced in this way can thus have inner pins 17 of different lengths while maintaining a constant overall density, as can be seen in Figures 14 and 15. Figure 14 shows a solid-state separator 1 having a short inner pin 17, while the solid-state separator 1 shown in Figure 15 has a significantly longer inner pin 17, with a length 18 of the inner pin 17 exceeding the length of the pin 15 and penetrating into the first section 21 of the ballast body 10. List of reference symbols 1 solid-state separator 2 first component 3 second component 4 Body fluid 5 first material 6 second material 7 first component 8 second component 9 floats 10 ballast bodies 11 Blood 12 Blood plasma 13 Blood serum 14 Valve 15 cones 16 passage opening 17 inner tenons 18 Length of the inner tenon 19 sample containers 20 blood collection tubes 21 First Section 22 Second Section 23 grooves 24 Anchoring element 25 bridge 26 Length of the tenon 27 Cavity 28 Sealing area 29 Sealing edge 30 outer diameter of the sealing edge 31 Inner diameter of the blood collection tube 32 Longitudinal axis of the float 33 Connecting element 34 Underside of the float 35 Overlap area 36 support brackets 37 Underside of the ballast body 38 Anchoring point 39 Longitudinal axis of the solid-state separator 40 Longitudinal axis of the blood collection tube 41 Bottom of the blood collection tube 42 Flow path 43 Border 44 cavity 45 Top of the first component 46 Bottom of the first component 47 Reversal area Section 48 49 recess 50 connection point 51 Bottom of the solid-state separator 52 wall 53 Direction of rotation 54 tools 55 mold tool 56 Contact area Pi first density p2 second density pTotal total density V1 first volume v2 second volume

Claims

Claims 1. A solid-state separator (1) for separating at least two components (2, 3) of a body fluid (4), wherein a first component (2) of the body fluid (4) has a first density and a second component (3) of the body fluid (4) has a second density, wherein a total density of the solid-state separator (1) lies between the first and the second density of the components (2, 3) of the body fluid (4) to be separated, comprising at least one ballast body (10), at least one floating body (9), wherein the ballast body (10) and the floating body (9) are movable relative to one another, in particular upon the action of a centrifugal force on the solid-state separator (1), wherein the solid-state separator (1) has at least one elastically deformable connecting element (33) which forms a force-transmitting connection between the floating body (9) and the ballast body (10),such that - starting from a rest state - for a relative movement between the floating body (9) and the ballast body (10), a force is required to overcome a restoring force defined by the connecting element (33), wherein the connecting element (33) overlaps the ballast body (10) or the floating body (9) in at least one overlapping region (35), characterized in that the connecting element (33) is connected to the ballast body (10) or the floating body (9) in at least one anchoring point (38) in such a way that during a relative movement, in particular as a result of the action of a centrifugal force on the solid-state separator (1) floating in the body fluid (4), the connecting element (33) is prevented from deforming in at least one section of the overlapping region (35).

2. Solid-state separator (1) according to claim 1, characterized in that the ballast body (10) is connected to the floating body (9) by means of a force fit or a form fit.

3. Solid-state separator (1) according to claim 1 or 2, characterized in that the connecting element (33) has at least one tab-shaped section (48).

4. Solid-state separator (1) according to one of the preceding claims, characterized in that the connecting element (33) is formed substantially from the same material as the floating body (9).

5. Solid-state separator (1) according to one of the preceding claims, characterized in that the connecting element (33) is connected to the ballast body (10) or the floating body (9) by means of at least one anchoring element (24) which preferably acts due to a positive connection, wherein the anchoring element (24) is preferably designed in the form of a web (25) or a pin (15).

6. Solid-state separator (1) according to one of the preceding claims, characterized in that the floating body (9) and / or the ballast body (10) has at least one groove (23) in the overlapping region (35).

7. Solid-state separator (1) according to one of the preceding claims, characterized in that the connecting element (33) has at least one retaining bracket (36) which at least partially encompasses the floating body (9) or the ballast body (10).

8. Solid-state separator (1) according to claim 7, characterized by a plurality of retaining brackets (36).

9. Solid-state separator (1) according to claim 7 or 8, characterized in that the connecting element (33) has four tab-shaped sections (48) and four retaining brackets (36) associated with the tab-shaped sections (48), wherein the tab-shaped sections (48) and the associated retaining brackets (36) are preferably each arranged at an angle of 90° to one another.

10. Solid-state separator (1) according to one of claims 7 to 9, characterized in that the retaining brackets (36) converge in an end region (48) of the solid-state separator (1).

11. Solid-state separator (1) according to one of the preceding claims, characterized in that the floating body (9) has a sealing area (28) wherein the sealing region (28) is integrally connected to the retaining bracket (36) by means of the connecting element (33).

12. Solid-state separator (1) according to one of claims 7 to 11, characterized in that a cross-sectional area of ​​the retaining bracket (36) exceeds a cross-sectional area of ​​the tab-shaped section (48) of the connecting element (33).

13. Solid-state separator (1) according to one of the preceding claims, characterized in that the ballast body (10) has a first section (21) and a second section (22), wherein the first section (21) is preferably hemispherical and the second section (22) is preferably cone-shaped.

14. Solid-state separator (1) according to one of claims 14, characterized in that the floating body (9) has a through-opening (16) into which the second section (22) of the ballast body (10) can be inserted to form a valve (14).

15. Solid-state separator (1) according to claim 13 or 14, characterized in that the first section (21) of the ballast body (10) has grooves (23) at least partially surrounding the ballast body (10).

16. Solid-state separator (1) according to claim 15, characterized in that the retaining bracket (36) runs in the grooves (23) of the ballast body (10).

17. Solid-state separator (1) according to one of the preceding claims, characterized in that the connecting element (33) is deformable during a relative movement between the floating body (9) and the ballast body (10), in particular as a result of a centrifugal force acting on the solid-state separator (1), such that contact between the connecting element (33) and the first section (21) of the ballast body (10) outside the anchoring point (38) can be temporarily and at least partially eliminated.

Images