Method for adjusting the overall density of a solid-state separator and set of solid-state separators

Abstract

The application relates to a method for setting a total density (ρ Gesamt ) of a solid separator (1) for separating at least two components (2, 3) of a body fluid (4), wherein the first component (2) has a first density (p1) and the second component (3) has a second density (ρ2) and wherein a target value of the total density (ρ Gesamt ) of the solid separator (1) lies between a value of the first and a value of the second density (ρ1, ρ2), the solid separator (1) comprising - a first material (5) and - a second material (6), wherein both materials (5, 6) are separate from each other in the solid separator (1). To develop a method for setting an overall density (ρ GesamtTo provide a solid-state separator (1) that is particularly simple and quick to implement and eliminates the disadvantages of the prior art, the invention provides that an inserted volume (V1, V2) of at least one of the materials (5, 6) of the solid-state separator (1) is adjusted depending on the determined current densities (ρ1, ρ2) of the two materials (5, 6), so that the value of the total density (ρ Gesamt ) of the solid separator (1) corresponds to the target value. Furthermore, the application relates to a set comprising at least two solid separators (1).

Description

[0001] The present application relates to a method for adjusting the overall density of a solid-state separator for separating at least two components of a body fluid according to the preamble of claim 1. Furthermore, the present invention relates to a set comprising at least two solid-state separators having the features according to claim 14.

[0002] 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 preserved in a separate state using the solid-state separator. For example, the solid-state separator can be used to separate urine, saliva, amniotic fluid, and intestinal fluid into their respective components.

[0003] 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.

[0004] To separate the components of body fluids, a solid-state separator is typically used in conjunction with a centrifuge. The solid-state separator is placed together with a body fluid in a sample container, typically a tube, 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 value of the total 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.

[0005] A problem with conventional solid-state separators has proven to be that the materials used to manufacture them are subject to batch-related variations. However, since the overall density of the solid-state separator is tailored to the body fluid to be separated, fluctuations in the densities of the materials result in the solid-state separator not positioning itself optimally between the components during centrifugation. This can result in unwanted mixing of the components after the centrifugation process has ended, or the receipt of an insufficient sample volume for body fluid analysis. State of the art

[0006] To solve the aforementioned problem, methods for adjusting the overall density of a solid-state separator are known. As an example, reference is made to the method described in WO 2016 / 069613 A1. The solid-state separator shown there is impermeable to liquids after insertion into a sample container, but has a sphere in its interior which, when subjected to centrifugal force, moves from a rest position against a spring, thus opening a passage for the body fluid. When the centrifugal force is removed, the force provided by the spring moves the sphere to the rest position, thus closing the passage. Furthermore, the solid-state separator comprises cavities in its interior which can be filled with a fluid depending on the densities of the body fluid components to be separated, in order to adjust the overall density of the solid-state separator.For example, the cavities can be filled with a liquid or gaseous composition during a manufacturing process. It can also be provided that the cavities enclose a vacuum.

[0007] However, a disadvantage of the known methods for adjusting the overall density of a solid-state separator has proven to be that the production of such solid-state separators is particularly complex. In particular, it cannot be ruled out that the composition filled into the cavities is also subject to fluctuations, which would have to be taken into account. Task

[0008] The object of the present invention is therefore to provide a method for adjusting the total density of a solid-state separator which can be carried out particularly simply and quickly and at the same time eliminates the disadvantages of the prior art. Solution

[0009] Based on the method mentioned above, the above task is solved by adjusting the volume used of at least one of the materials of the solid-state separator depending on the determined current densities of the two materials.

[0010] For the purposes of the present invention, the "total density" of the solid-state separator is understood as the quotient of the total mass and the total volume of the solid-state separator. The total mass consists of at least the masses of the two materials, and the total volume consists of at least the volumes of the two materials.

[0011] For the purposes of the present invention, the "target value" of the overall density does not necessarily refer to a single value. Rather, the target value can also be a range within which the overall density should lie.

[0012] The adjustment is carried out in such a way that the total density of the solid-state separator corresponds to a target value. The target value is based on the densities of the components of the body fluid to be separated. In the case of blood, the target value for the total density of the solid-state separator lies in a range between 1.040 and 1.045 g / cm 3The materials used to manufacture the solid-state separator have different densities, and these densities can be subject to batch-related fluctuations. If a volume of material with a varying density is maintained regardless of the fluctuation, it cannot be guaranteed that the total density of the solid-state separator will correspond to the target value. Rather, the total density of the solid-state separator will also fluctuate in such a case. This is due to the fact that the total density of the solid-state separator is determined from the quotient of the total mass and the total volume of the solid-state separator. The total mass, in turn, is determined from the sum of the masses of the materials used, and the total volume from the sum of the volumes of the materials used. If the solid-state separator is made of two materials, the total density of the solid-state separator can be determined as follows: ρTotal=m1+m2V1+V2=ρ1⋅V1+ρ2⋅V2V1+V2

[0013] Here, m1 represents the mass of the first material, m2 represents the mass of the second material, V1 represents the volume of the first material, and V2 represents the volume of the second material. The densities of the materials can be determined from the quotient of mass and volume, where ρ1 represents the density of the first material and ρ2 represents the density of the second material.

[0014] To prevent the overall density from fluctuating, the invention provides for first determining the densities of the materials. These densities can then preferably be compared with a respective target density of the materials. If deviations are detected between the determined densities of the materials to be used and the respective target density, a volume of the material(s) with a different density is adjusted during the production of the solid-state separator.

[0015] For example, if the density of the second material matches the target density, while the density of the first material deviates from the target density, the volume of the first material to be used can be determined as follows: V1=V2(ρtotal−ρ2)ρ1−ρtotal

[0016] The volume of the first material can be determined depending on the volume of the second material V2, the total density ρGesamt of the solid-state separator and the determined densities ρ1, ρ2 of the materials, whereby the total density is predetermined and the determined densities of the materials are fixed. The volume of the first material to be used can thus be adjusted depending on the volume of the second material to be used.

[0017] If the determined density of the first material is lower than the target density, the volume of the first material used must be adjusted accordingly, i.e. increased, in order to bring the overall density into line with the target value. Due to the difference in density between the first material and the target density and the resulting adjusted volume of the first material, the mass used of the material with the adjusted volume is also changed. If, for example, the density of the first material is increased compared to a target density, the volume used of the first material must be adjusted by reducing the volume to compensate for the increased density. During the adjustment, the mass used of the first material can also change. Conversely, the volume used must be increased if the density deviates downwards from the target density.

[0018] If both the first and second materials differ in density, the volumes of both materials must be adjusted. Here, too, the masses of both materials used can change.

[0019] The method according to the invention has many advantages. In particular, the method ensures that the overall density of the solid-state separator remains constant regardless of batch-related fluctuations in the densities of the materials used. This is made possible, in particular, by determining the densities of the materials used before the solid-state separator is manufactured. In this way, the overall density of the solid-state separator can be easily adjusted by adjusting the volume of the material with a different density. This adjustment is advantageously carried out during the production of the solid-state separator, so that no further adjustments need to be made to the solid-state separator as the final product.

[0020] A further particular advantage of the process is that the overall density of the solid-state separator can be easily and quickly adjusted. Unlike prior art processes, the laborious filling of a cavity is not necessary. Instead, the overall density can be easily adjusted by adjusting the volume of at least one material used.

[0021] It is also conceivable that the solid-state separator comprises at least one additional component. For example, it is conceivable that the solid-state separator has three components.

[0022] According to a preferred embodiment of the invention, it is provided that the first material forms a first component and the second material forms a second component, wherein the components are connected to one another, preferably interlocking in a form-fitting manner.

[0023] 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 designed separately from another component or other elements of the solid-state separator. Rather, the component can also be designed integrally with other components and / or elements of the solid-state separator.

[0024] It can be provided that the solid-state separator comprises at least two components, wherein a first component is formed from or comprises the first material and a second component is formed from or comprises the second material. The two components are connected to one another, wherein it can preferably be provided that the components close a through-opening of the solid-state separator when the solid-state separator is at rest. Under the action of a centrifugal force, in particular during centrifugation of the solid-state separator, the components move in the sample container due to the different densities of the materials used and preferably open the through-opening. For example, it can be provided that the through-opening is closed due to another component of the solid-state separator when the solid-state separator is at rest.To ensure that the solid-state separator automatically closes the passage opening again once the centrifugal force ceases, the components are connected to one another. Preferably, the components are connected to one another in a form-fitting manner. In particular, the solid-state separator can comprise at least one floating body and at least one ballast body, wherein the ballast body is predominantly formed from the first material and the floating body is predominantly formed from the second material.

[0025] For the purposes of this application, a "floating body" is understood to mean a component of the solid-state separator made of a material whose density is lower than the density of the body fluid component with the higher density. During the centrifugation process, the floating body therefore "floats" on the body fluid component with the higher density. Under the influence of a centrifugal force, the floating body experiences a lower force than the ballast body.

[0026] For the purposes of this application, a "ballast body" is understood to mean a component of the solid-state separator made of a material whose density is greater than the density of the lower-density component of the body fluid. During the centrifugation process, the ballast body is therefore positioned below the lower-density component of the body fluid. Under the influence of the centrifugal force, the ballast body experiences a greater force than the floating body.

[0027] It has proven useful to separate the floating body and the ballast body, also with regard to material selection. In other words, it can be particularly advantageous if the ballast body is made entirely of the first material, while the floating body is made entirely of the second material.

[0028] Furthermore, the solid-state separator can comprise three components. A first component can be designed as a floating body. A second component can be a hard component that encloses a third component. The second and third components form a ballast body.

[0029] A preferred embodiment of the invention further provides that the first material is hard, at least after the solid-state separator has been manufactured. For the purposes of the present application, a "hard" material is understood to mean a material that is neither soft nor elastic and that yields little or not at all under the action of force. The hardness of the material ensures that the solid-state separator does not deform, or only slightly deforms, under the action of centrifugal force. The choice of a hard material has proven particularly advantageous, particularly in cases where the solid-state separator, due to its external geometry, is adapted to a sample container to form a sealing insert.

[0030] According to a further preferred embodiment of the invention, it is provided that the first material and / or the second material is / are a plastic material. The use of plastic materials has also proven to be particularly advantageous from an economic point of view, since the solid-state separator can thus be manufactured particularly easily and cost-effectively. Since the solid-state separator is generally only used once, the use of plastic material is particularly advantageous. In particular - if plastic materials are used - according to a preferred embodiment of the invention, it can be provided that the solid-state separator is manufactured by means of an injection molding process, wherein the adjustment of the volume used takes place during the injection molding process, preferably by changing the geometry of a mold.Manufacturing the solid-state separator using the injection molding process has proven particularly cost-effective. Furthermore, the geometry of the solid-state separator can be adapted particularly easily and quickly by changing the geometry of the mold used. In particular, the volume of a material with a different density can be easily adjusted. It is conceivable that only one mold for producing the solid-state separator would need to be adapted to adjust the material volume.

[0031] According to a preferred embodiment of the invention, it is provided that the total volume of the solid-state separator remains the same and only a ratio of the volume of the first material used to the volume of the second material used is changed. In other words, to adapt the solid-state separator, a volume of the first material is reduced or increased compared to a volume of the second material. The reverse case is also conceivable. In the event that the density of the first material is lower than the predetermined target density, it can preferably be provided that the volume of the second material used is reduced while the volume of the first material used is increased in order to compensate for the fluctuation in density while maintaining the same total volume.

[0032] A preferred embodiment provides for the total volume of the solid-state separator to be changed. If the volume of at least one material used is changed, the total volume is also indirectly changed without any further measures. The total volume can be increased or decreased compared to a "standard" solid-state separator, whose materials match the target densities.

[0033] A further preferred embodiment of the invention provides that an external shape of the solid-state separator remains unchanged. In other words, the adjustment of the volume of at least one material used is not visible on the solid-state separator from the outside. This is particularly advantageous when an external shape of the solid-state separator is adapted to a standardized or normed sample container. In particular, if the solid-state separator is designed such that the solid-state separator is intended to form a seal within the solid-state separator, it is even necessary for the external shape, at least in a sealing region of the solid-state separator, to remain unchanged even after the volume has been adjusted.

[0034] A particularly preferred further development of the solid-state separator according to the invention provides that the body fluid to be separated is blood, with the components to be separated being the blood plasma and the blood serum. During a centrifugation process, a leukocyte film (buffy coat) is also formed, which is arranged between the blood plasma and the blood serum. When separating blood, it can be provided that the target density of the first material is in the range of 1.3 g / cm 3 up to 1.5 g / cm 3 while the target density of the second material is in the range of 0.8 g / cm 3 up to 1.0 g / cm 3 The total density of the solid state separator should therefore be between a density of blood plasma, which is approximately 1.03 g / cm 3 and a blood serum density of approximately 1.11 g / cm 3 amounts to.

[0035] Preferably, the floating body and the ballast body together can form a valve, wherein the ballast body or the floating body preferably has a pin that can be inserted into a through-opening of the floating body or the ballast body, wherein the overall density of the solid-state separator is preferably adjusted by changing a geometry of the pin. Preferably, it can be provided that the ballast body and the floating body move away from each other when the centrifugal force acts due to their different densities. In this process, the pin is removed from the through-opening. It can be particularly advantageous if the pin is assigned to the ballast body, while the floating body has the through-opening. The reverse case, in which the ballast body has the through-opening and the floating body has the pin, is also conceivable.Furthermore, in this case, it is particularly preferred if the outer shape of the solid-state separator is adapted such that the solid-state separator, both at rest and after separation of the components, rests tightly against a wall of the sample container. During the centrifugation process, the solid-state separator can be provided to move within the sample container in order to position itself between the components of the body fluid to be separated. An exchange of the components is possible, in particular, through the through-opening.

[0036] Preferably, the ballast body can be formed from or contain the first material. The volume of the ballast body can preferably be adjusted by adjusting the geometry of the pin. In this way, the volume can advantageously be adjusted without changing the external shape of the solid-state separator.

[0037] It can further preferably be provided that the pin of the ballast body has at least one inner pin. In such a case, it is particularly preferred if the overall density of the solid-state separator is adjusted by changing the length of the inner pin of the pin. It is conceivable that the pin has a cavity and the inner pin projects into the cavity of the pin. It can preferably be provided that a length of the inner pin in a target state differs from a length of the pin. In particular, it can be provided that the inner pin is shorter than the pin when the target state is present. The target state is present precisely when the densities of the materials match the target densities.Due to the difference in length when the target state is present, the length of the inner pin can advantageously be adjusted, in particular by extending the inner pin, provided the densities of the materials deviate from the target densities - i.e., the target state is not present at the time. By adjusting the length of the inner pin, the volume of the material can be adjusted. If the inner pin is already shorter than the pin when the target state is present, it can be ensured that the inner pin can be extended to adjust the volume of the material without the inner pin exceeding the length of the pin's cavity. Advantageously, the adjustment of the inserted volume is therefore not noticeable to an observer of the solid-state separator. This also ensures that the external shape of the solid-state separator can be retained.

[0038] The object stated at the outset is further achieved by means of a set having the features according to claim 14. The set comprises two solid-state separators. A first solid-state separator has a first material with a first density and a second material with a second density, while a second solid-state separator also has the first and second materials, but the first material has a third density and the second material a fourth density. The first and third densities and / or the second and fourth densities differ from one another. The total densities of the solid-state separators, however, are the same. In other words, the two solid-state separators have the same materials but differ in the densities of the materials. While the density of the first material in the first solid-state separator has a first value, the density of the first material in the second solid-state separator has a second value.The same applies to the second material. However, due to these differences, it is still possible for the total densities of the solid-state separators to match. This is made possible, in particular, by adjusting the volumes of the materials used so that the total densities correspond to a target value.

[0039] For the purposes of the present invention, when comparing a material with a first density with the same material with a second density, the second-mentioned material is understood to be a material that has the same material parent as the material being compared. Materials differing in density are therefore not necessarily chemically identical, but they do belong to the same material parent.

[0040] The set according to the invention has many advantages. In particular, the two solid-state separators in the set have identical overall densities, even though the densities of the individual materials differ, at least in part. Due to their identical overall densities, both solid-state separators in the set can thus be used to separate the same body fluid, even though the densities of the materials used differ.

[0041] A further embodiment of the invention provides that each of the solid-state separators comprises at least one floating body and at least one ballast body, wherein each of the ballast bodies is predominantly formed from the first material and each of the floating bodies is predominantly formed from the second material. The advantages mentioned with regard to the solid-state separator with the features according to claim 3 apply analogously to the set.

[0042] According to a preferred embodiment of the invention, it is further provided that the total volume of the two solid-state separators is identical. In this case, the solid-state separators are constructed identically. Due to the identical total volumes and the identical total densities, the total masses of the two solid-state separators are also identical.

[0043] An alternative preferred embodiment of the invention provides for the total volume of the solid-state separators to differ from one another. In such a case, although the total densities of the two solid-state separators are identical, the total volumes and thus also the total masses of the solid-state separators differ.

[0044] Nevertheless, in this case it can preferably be provided that the solid separators are identical in their external shape. Viewed from the outside, it is therefore not apparent that the solid separators have different total volumes. This can be made possible in particular by one shape of the solid separator differing from the shape of the other solid separator only in an internal aspect. For example, it can be provided that each solid body has a pin, which in turn has an inner pin. The length of the inner pins of the two solid separators can differ in such a way that the total volumes differ from one another. At the same time, the geometry of the inner pin is adapted such that the total densities match. Examples of implementation

[0045] 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 manufactured according to the method 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 Fig. 1. Fig. 3: A perspective view of a ballast body of the solid state separator according to the invention from Fig. 1. Fig. 4: Another perspective view of the ballast body from Fig. 3 in a vertical section. Fig. 5: A perspective view of the solid state separator from Fig. 1. Fig. 6: A vertical section through the solid state separator from Fig. 1. Fig. 7: How Fig. 6, whereby a centrifugal force acts on the solid separator. Fig. 8: A horizontal section through a sample container, where the solid state separator consists of Fig. 1 is in an initial position in the sample container. Fig. 9: How Fig. 1, showing different stages of movement of the solid-state separator. Fig. 10: A detailed view of the solid separator during a centrifugation process. Fig. 11: Remove the sample container with the solid state separator from Fig. 1 in a final state of the solid separator after the centrifugation process. Fig. 12: The ballast body of the solid state separator from Fig. 1 during a manufacturing process. Fig. 13: The solid state separator from Fig. 1 during a manufacturing process. Fig. 14: Another view of the solid state separator from Fig. 1 during a manufacturing process. Fig. 15: Another solid-state separator according to the invention during a manufacturing process.

[0046] A solid state separator 1 produced according to the method according to the invention is shown in the Fig. 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 placed into a sample container 19 in the form of a blood collection tube 20. As can be seen from Fig. 1 shows the solid-state separator 1, which was previously 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.

[0047] 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 in Fig. 2, the ballast body 10 in the Fig. 3 and Fig. 4. A composite state of the solid state separator 1 is shown in the Fig. 5 to 7. The ballast body 10 is formed from a first material 5, while the floating body 9 is formed from a second material 6. Both components 7, 8 are made of plastic. The first material 5 forming the ballast body 10 has a first density ρ1 that is greater than a density ρ2 of the second material forming the floating body 9. The second density ρ2 is less than the density of the blood serum 13, and the first density ρ1 is greater than the density of the blood plasma 12. The total density ρ Gesamt of the solid-state separator 1 lies between the density of blood plasma 12 and the density of blood serum 13.

[0048] 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.

[0049] 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 which do not have a groove 23. The pin 15 of the ballast body 10 is - as can be seen from the Fig. 4 - is 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 the Fig. 6 is evident.

[0050] The floating body 9 is designed in the form of a funnel and has a sealing area 28 at an upper end. A circumferential sealing edge 29 is formed on the sealing area 28 for a circumferentially sealing contact 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 in particular in Fig. 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 which extends through the floating body 9 along a longitudinal axis 32 of the floating body 9.

[0051] 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 9. The pin 15 of the ballast body 10 is in a rest state of the solid-state separator 1, which in Fig. 5, is inserted into the through opening 16 of the floating body 9 and closes it in a liquid-tight manner.

[0052] 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.

[0053] 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.

[0054] 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 overlap region 35. The webs 25 in the ballast body 10 serve as anchoring elements 24. The webs 25 are positively connected, on the one hand, to the retaining brackets 36 and, on the other hand, to the tab-shaped sections 48 of the connecting element 33 outside the overlap region 35.

[0055] The floating body 9 and the connecting element 33 are made of the same material and are formed in one piece. The tab-shaped sections 48 of the connecting element 33 connect the retaining brackets 36 in one piece with the sealing area 28 of the solid-state separator 1, as can be seen particularly well from Fig. 2. It is also evident that the cross-sectional area of ​​the retaining brackets 36 exceeds the cross-sectional area of ​​the tab-shaped sections 48 of the connecting element 33. In other words, the retaining brackets 6 are thicker than the tab-shaped sections 48 of the connecting element 33.

[0056] The solid state separator 1 under the influence of a centrifugal force is in the Fig. 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 process, the connecting element 33 is elastically deformed in the area outside the overlap region 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.

[0057] 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 is eliminated during the duration of the centrifugation process, as can be seen in particular from Fig. 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 influence of centrifugal force.

[0058] The sealing area 28 of the floating body 9 is squeezed when inserted into the blood collection tube 20 in such a way 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 relative to an initial position, which is Fig. 2 to 7, rotated by 90° 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 the Fig. 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. Subsequently, the blood collection tube 20 with the solid-state separator 1 is 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 Fig. 9 shown.

[0059] 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.

[0060] 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 the density differences. 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, so that a flow path 42 for the components 2, 3 of the blood 11 is released, as can be seen in particular from Fig. 10. In this way, the components 2, 3 can be arranged above and below the solid separator 1 depending on their density.

[0061] Since the total density ρ Gesamtof 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 arranges itself after the separation of the two components 2, 3 at a boundary 43 between the two components 2, 3, as can be seen from the Fig. 10. The total density ρ Gesamtof the solid-state separator 1 is preferably selected such that a lowest point of the through-opening 16 of the solid-state 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-state separator 1 when the centrifugal force decreases. At the same time, the distance is selected 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.

[0062] The different stages of the solid separator 1 during its movement are shown in the Fig. 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.

[0063] 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 already inserted back into the through-opening 16 when the centrifugal force is reduced and does not move back into the through-opening 16 until the centrifugal force is completely eliminated. Such a state is in the Fig. 7 shown.

[0064] The fact that the solid-state separator 1 arranges itself at the boundary 43 between the components 2, 3 even in the case of fluctuations in the density ρ1, ρ2 of the two materials used is achieved in the course of the production of the solid-state separator 1 by means of the method according to the invention for adjusting the total density ρ Gesamt of the solid state separator 1 is ensured.

[0065] The total density ρ Gesamt of the solid state separator 1 is calculated as follows: ρTotal=m1+m2V1+V2=ρ1⋅V1+ρ2⋅V2V1+V2

[0066] Due to fluctuations in the density ρ1 of the first material 5 and / or the density ρ2 of the second material 6, a deviation of a value of the total density ρ Gesamt of the solid state separator 1 from a target value of the total density ρ required for optimal separation of the components 2, 3 of the blood 11 Gesamtof the solid-state separator 1. To avoid this, the densities ρ1, ρ2 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 in order for the value of the total density ρ Gesamt of the solid-state separator 1 is optimally adjusted. Depending on the material 5, 6 whose density ρ1, ρ2 deviates from the target density, an inserted volume V1, V2 of the first material 5 and / or the second material 6 is adjusted. The adjustment of the volume V1, 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 the Fig. 12 is shown.

[0067] In the event that the density ρ1 of the first material 5 forming the ballast body 10 is reduced compared to the target density, the value of the total density ρ Gesamtby means of an extension of the inner pin 17. Conversely, the value of the total density ρ Gesamt by shortening the inner pin 17, provided the density ρ1 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: V1=V2(ρtotal−ρ2)(ρ1−ρtotal)

[0068] The solid state separator 1 is used as in Fig. 13, using the injection molding process. 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 each other, 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 seen in particular from Fig. 4 is clearly visible - whereby the recess 49 is closed at three connection points 50 between the inner pin 17 and the pin 15.

[0069] After the first material 5 has hardened, the molding tool 55 is transferred from a first molding position into 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. The second material 6 is finally introduced into the molding tool 55 in a second process step 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. The second material 6 flows as in the Fig. 14 and Fig. 15, starting 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 lower side 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 upper side 45 of the first component 7. In a final state, the second material 6 completely fills the cavity 44 that was present 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, wherein complete removal of the floating body 9 from the ballast body 10 is prevented due to the force-fitting connection of the connecting element 33 in the anchoring points 38.

[0070] In order to be able to adjust a length 18 of the inner pin 17 during the manufacturing process and thus to change a volume of the first component 7, a further tool 54 can be used, which is inserted into the molding tool 55 before the first material 5 is introduced, as can be seen in particular from the Fig. 12. The tool 54 limits the flow of the first material 5 toward a bottom side 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.

[0071] The solid-state separator 1 produced in this way can thus be used with constant total density ρ Gesamt have differently long inner pins 17 as shown in the Fig. 14 and Fig. 15. In the Fig. 14 shows a solid state separator 1 which has a short inner pin 17, while the one in the Fig. 15 has a significantly longer inner pin 17, wherein a length 18 of the inner pin 17 exceeds the length of the pin 15 and penetrates 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 ρ1 first density ρ2 second density ρ Gesamt Total density V1 first volume V2 second volume QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] WO 2016 / 069613 A1

[0006]

Claims

[1] Method for adjusting a total density of a solid-state separator (1) for separating at least two components (2, 3) of a body fluid (4), wherein the first component (2) has a first density (p1) and the second component (3) has a second density (ρ2), and wherein a target value of the total density (ρ Gesamt ) of the solid-state separator (1) lies between a value of the first and a value of the second density (ρ1, ρ2), the solid-state separator (1) comprising - a first material (5) and - a second material (6), both materials (5, 6) being present separately from one another in the solid-state separator (1), characterized by the following procedural step: Adjusting an inserted volume (V1, V2) of at least one of the materials (5, 6) of the solid separator (1) depending on the determined current densities (ρ1, ρ2) of the two materials (5, 6), so that the value of the total density (ρ Gesamt) of the solid state separator (1) corresponds to the target value. [2] Method according to claim 1, characterized by that the first material (5) forms a first component (7) and the second material (6) forms a second component (8), wherein the components (7, 8) are connected to one another, preferably interlocking in a form-fitting manner. [3] Method according to claim 1 or 2, characterized by that the solid-state separator (1) comprises at least one floating body (9) and at least one ballast body (10), wherein the floating body (9) is formed predominantly from the second material (6) and the ballast body (10) is formed predominantly from the first material (5). [4] Method according to one of the preceding claims, characterized by that the first material (5) is hard, at least after the solid-state separator (1) has been manufactured. [5] Method according to one of the preceding claims, characterized bythat the first material (5) and / or the second material (6) is / are a plastic material. [6] Method according to one of the preceding claims, characterized by that the solid-state separator (1) is produced by means of an injection molding process, wherein the adjustment of the volume used (V1, V2) takes place during the injection molding process, preferably by changing the geometry of a molding tool (55). [7] Method according to one of the preceding claims, characterized by that the total volume of the solid-state separator (1) remains the same and only a ratio of the volume used (V1) of the first material (5) to the volume used (V2) of the second material (6) is changed. [8] Method according to one of claims 1 to 6, characterized by that the total volume of the solid separator (1) is changed. [9] Method according to one of the preceding claims, characterized bythat an external shape of the solid state separator (1) is not changed. [10] Method according to one of the preceding claims, characterized by that the body fluid (4) to be separated is blood (11), wherein the components (2, 3) to be separated are the blood plasma (12) and the blood serum (13) of the blood (11). [11] Method according to one of claims 3 to 10, characterized by that the floating body (9) and the ballast body (10) together form a valve (14), wherein the ballast body (10) or the floating body (9) preferably has a pin (15) which can be inserted into a through-opening (16) of the floating body (9) or the ballast body (10), wherein preferably the total density (ρ Gesamt ) of the solid-state separator (1) is adjusted by changing a geometry of the pin (15). [12] Method according to claim 11, characterized by that the pin (15) of the ballast body (10) has at least one inner pin (17). [13] Method according to claim 12, characterized by that the total density (ρ Gesamt ) of the solid-state separator (1) is adjusted by changing a length (18) of the inner pin (17) of the pin (15). [14] Set comprising at least two solid state separators (1), wherein - a first solid-state separator (1) comprises a first material (5) with a first density (p1) and a second material (6) with a second density (ρ2) and - a second solid-state separator (1) comprises the first material (5) with a third density and the second material (6) with a fourth density, - wherein the first (p1) and the third density and / or the second (p1) and the fourth density differ from each other, - where the total densities (ρ Gesamt ) of the two solid state separators (1) match. [15] Set according to claim 14, characterized bythat each of the solid-state separators (1) comprises at least one floating body (9) and at least one ballast body (10), wherein each of the floating bodies (9) is formed predominantly from the second material (6) and each of the ballast bodies (10) is formed predominantly from the first material (5). [16] Set according to claim 14 or 15, characterized by that the total volume of the two solid separators (1) is identical. [17] Set according to claim 14 or 15, characterized by that a total volume of the solid separators (1) differs from each other. [18] Set according to one of claims 14 to 17, characterized by that the solid state separators (1) are identical in their external shape.

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