Method for manufacturing a solid-state separator

Abstract

The present application relates to a method for manufacturing a solid separator (1) using the injection molding process, comprising the following process steps: a) Injecting a first material (5) into a mold (55) to form a first component (7). b) Injecting a second material (6) into the same or a further mold (55) to form a second component (8), wherein the second material (6) flows at least partially through a cavity (27) of the first component (7) without forming a material bond with the first component (7).

Description

[0001] The present application relates to a method for manufacturing a solid separator using the injection molding process with the features according to claim 1.

[0002] Solid-state separators are used to separate the components of a bodily fluid. One component of the bodily fluid has a first density, and the other component has a second density. The bodily fluid in question can be blood, with the components to be separated being blood serum, blood plasma, and the leukocyte film (buffy coat). However, any other bodily fluid can also be separated into its components and kept separate using a solid-state separator. For example, a solid-state separator can be used to separate urine, saliva, amniotic fluid, and intestinal fluid into their respective components.

[0003] A solid-state separator typically consists of a first and a second material, which are separated within the separator. To separate the components of body fluid, a solid-state separator is generally used in conjunction with a centrifuge. The separator is placed in a sample container, typically a tube, along with the body fluid, and then centrifuged. Due to the centrifugal force acting on the body fluid and the different densities of the two components, the components separate. Since this separation process only lasts as long as the centrifugal force acts on the body fluid, the solid-state separator is necessary.The target density of the solid-state separator lies between the densities of the two components, ensuring that the separator positions itself between them during centrifugation. The separator is typically designed to allow an exchange of components during centrifugation, but to prevent this exchange once the centrifugal force is removed. In this way, the components of the body fluid remain separated in the sample container even after centrifugation, i.e., once the centrifugal force is removed.

[0004] Since solid separators are generally only used once, they are typically made of plastic and therefore usually manufactured using the injection molding process. State of the art

[0005] Numerous methods for manufacturing solid separators using injection molding are known from the prior art. By way of example, reference is made to European patent EP 232 6421 B1, which describes a solid separator comprising a ballast body and a float. It describes that a first assembly of the solid separator, comprising a pierceable head and the float, and a second subassembly of the solid separator, comprising a bellows and the ballast body, are molded or extruded separately and then assembled. Alternatively, the ballast body can be formed first, followed by the float, with the float being molded onto the ballast body. Task

[0006] The object of the present invention is to provide an alternative method for manufacturing a solid-state separator. Solution

[0007] Starting from the aforementioned method for manufacturing a solid-state separator, the above problem is solved by a method with at least two process steps. In a first process step, a first material is injected into a mold. This creates a first component. The first component has at least one cavity. In a second process step, a second material is injected into the same mold or another mold. This creates a second component. During the injection of the second material, it flows at least partially through the cavity of the first component without forming a metallurgical bond with the first material.

[0008] For the purposes of this application, a "component" is understood to be a part of the solid-state separator. The component need not necessarily 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.

[0009] The inventive method has many advantages. A particular advantage of the method is that the second component is produced while the first component is already in place. Although the two components are formed at different times, the method is an improvement over the prior art because the second material can flow particularly easily through the cavity in the first component into the mold. Only the transfer of the first component to a second mold may be necessary. At the same time, it is ensured that the two components remain movable relative to each other even after the materials have hardened, since the components do not form a material bond with each other.

[0010] If the second material is injected into the same mold, it is not necessary to remove the first component from the mold. Instead, the component can remain in the mold, and the second material is injected through the cavity in the first component into the same mold. In such a case, however, it may be necessary to reposition the mold after the first component has been formed. Even then, however, replacing the mold is not required. This method allows for particularly simple and rapid production of the solid-state separator.

[0011] Preferably, the two materials used to manufacture the solid separator have different densities, with the density of the first material preferably being greater than the density of the second material. The reverse is also conceivable.

[0012] According to a preferred embodiment of the invention, the second material is injected into the mold from a top surface of the first component, through the cavity of the first component, and onto a bottom surface of the first component. In a particularly preferred manner, the first material may be allowed to fully cure before the second material is injected into the mold through the cavity of the first component. The first component is already in the mold when the second material is injected. If the second material is injected into the same mold as the first material, it can be guided into the mold particularly easily through the cavity of the first component.

[0013] Preferably, it is further provided that, after reaching a reversal zone of the first component, the second material flows from the reversal zone outwards, at least over a portion of the outer surface of the first component up to its top surface, wherein the reversal zone is preferably an underside of the first component. In other words, the second material is injected through the cavity in the first component and then flows around it. The first component is preferably completely enclosed by the second material, since both the cavity and an outer surface of the first material are surrounded by the second material. Alternatively, it is also conceivable that the first component is not completely surrounded by the second material, but only partially, preferably in predetermined sections.

[0014] According to a further preferred embodiment of the invention, the second material at least partially fills the cavity of the first component in the final state of the solid-state separator. The second material thus not only flows through the cavity in the first component, but also remains at least partially in the cavity after the second component has been completed. It is also possible for the second material to completely fill the cavity of the first component in the final state of the solid-state separator.

[0015] A preferred embodiment further provides that the first material is a thermoplastic and the second material is a thermoplastic elastomer. The use of these materials has proven particularly advantageous for the injection molding process for manufacturing a solid-state separator, as they do not adhere to one another. Preferably, the first material may have a higher melting point than the second material. Furthermore, it has been found that the viscosity of the second material should preferably be adapted to ensure that it can fill cavities in the mold as completely as possible, even across narrow cross-sections and complex or long flow paths within the mold.

[0016] An advantageous embodiment of the invention provides that the first component constitutes at least a predominant portion of a ballast body of the solid-state separator and / or the second component constitutes at least a predominant portion of a float body of the solid-state separator. Preferably, the second material forms the float body of the solid-state separator as well as other elements of the solid-state separator, while the first material forms the ballast body. The other elements of the solid-state separator can be integrally formed with the float body. The float body is distinguished from the other elements solely by its function. A difference in the material used is not necessarily required.

[0017] In the event that the first component constitutes the ballast body and the second component the float body, it may be preferable to adjust the viscosity and melting point of the materials used for the components accordingly.

[0018] Preferably, the first material—and thus also the ballast—can have a higher density than the second material. A centrifugal force acting on the ballast during a centrifugation process to separate components of a body fluid is therefore greater than the force acting on the float. As a result, the float and ballast move away from each other.

[0019] A particularly advantageous further development of the method according to the invention provides that the ballast body has a pin, wherein the pin is formed in the first process step and has a cavity such that the second material flows through the cavity in the pin during the manufacture of the solid separator. The pin itself can in turn have an inner pin that projects into the cavity. The second material can preferably be introduced into the cavity from an upper surface of the pin through recesses on the upper surface, flowing around the inner pin and completely surrounding it after completion of the second component.

[0020] Preferably, the float has a through-opening into which the pin of the ballast can be inserted, the through-opening of the float and the pin of the ballast together forming a valve. Preferably, it can be provided that, under the influence of centrifugal force, the ballast moves away from the float due to the different densities of the float and the ballast. In this process, the pin is removed from the through-opening. It can be particularly advantageous if the pin is associated with the ballast, while the float has the through-opening. The reverse case, where the ballast has the through-opening and the float has the pin, is also conceivable.Furthermore, it is particularly preferred in this case if the external shape of the solid separator is adapted such that, in its resting state and after separation of the components, the solid separator seals against the wall of a sample container holding the body fluid to be separated. During the centrifugation process, the solid separator may be able to move within the sample container to position itself among the components of the body fluid to be separated. An exchange of the components is facilitated, in particular, through the through-opening.

[0021] A further embodiment of the invention provides that the components are movable relative to each other in a final state. Relative movement of the two components is made possible by the fact that the components do not form a material-bonded connection. It can be provided that the solid-state separator, in addition to the float and the ballast, comprises at least one elastically deformable connecting element, which forms a force-transmitting connection between the float and the ballast, so that – starting from a state of rest – a force is required to overcome a restoring force defined by the connecting element for relative movement between the float and the ballast.Due to the elastic deformability of the connecting element, it also ensures that the relative motion is reversed after the force is removed, so that the float and ballast return to their corresponding positions, which they occupied when initially at rest. If the ballast pin, together with the float's cavity, forms a valve, the pin can be designed to be inserted into the cavity when at rest. Under the influence of force, the pin is removed from the cavity and the valve opens. After the force is removed, the connecting element retracts the pin into the float's cavity, thus closing the valve.

[0022] Furthermore, it can be particularly advantageous if the forming tool assumes a first forming position in the first process step and is transferred to a second forming position in the second process step. In this way, a single forming tool can be used. The forming tool then only needs to be changed in its forming position.

[0023] An advantageous embodiment of the invention provides that an interior space enclosed by the mold in the first mold position essentially corresponds to a final shape of the ballast body, and that an interior space enclosed by the mold in the second mold position essentially corresponds to a final shape of the solid separator. In other words, the first component is formed first. A final shape, in particular an outer contour, of the first component corresponds to an interior space enclosed by the mold in a first mold position. The first material therefore only needs to be inserted into the mold. Preferably, after the first material has hardened, the mold is transferred to a second mold position, which has a larger volume than the first mold position. Subsequently, the second material is inserted into the mold through the cavity in the first component.The interior space enclosed by the mold in the second mold position corresponds to the final shape of the solid-state separator. After the second material has hardened, the solid-state separator is complete, and only the mold needs to be removed. Advantageously, the use of a second mold is not required. Manufacturing can therefore be carried out particularly easily and quickly by transferring the mold between the mold positions. Examples of implementation

[0024] The invention is explained in more detail below with reference to an exemplary embodiment shown in the figures. These show: Fig. 1: A vertical section through a sample container, wherein a solid separator produced according to the inventive method is located in a starting position in the sample container. Fig. 2: A perspective view of a floating body of the solid body separator made of Fig. 1. Fig. 3: A perspective view of a ballast body of the solid-state separator made of 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 separator made of Fig. 1. Fig. 6: A vertical section through the solid separator made of Fig. 1. Fig. 7: How Fig. 6, wherein a centrifugal force acts on the solid separator. Fig. 8: A horizontal section through a sample container, showing the solids separator made of Fig. 1 is in a starting position in the sample container. Fig. 9: How Fig. 1, showing different stages of movement of the solid separator. Fig. 10: A detailed view of the solid separator during a centrifugation process. Fig. 11: Remove the sample container with the solids separator from Fig. 1 in a final state of the solid separator after the centrifugation process. Fig. 12: The ballast body of the solid separator made of Fig. 1 during a manufacturing process. Fig. 13: The solid separator made of Fig. 1 during a manufacturing process. Fig. 14: Another view of the solid-state separator made of Fig. 1 during a manufacturing process. Fig. 15: Another solid separator during a manufacturing process.

[0025] A solid-state separator 1 produced according to the inventive method is in the Fig. Figures 1 to 15 show the solids separator 1. This separator serves to separate components 2 and 3 of a body fluid 4 with different densities by means of a centrifugation process. The centrifugation process is an essential part of the pre-analytical phase of blood 11 for medical purposes. For this purpose, blood 11 is drawn from a patient and placed into a sample container 19 in the form of a blood collection tube 20. The blood collection tube 20 already contains—as shown in Figures 1 to 15—the following components: Fig. 1 visible - the solid 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.

[0026] The solid separator 1 has two interconnected components 7, 8 that are movable relative to each other: a float 9 and a ballast 10. The float 9 is in Fig. 2 shown, the ballast body 10 in the Fig. 3 and Fig. 4. A composite state of the solid separator 1 is in the Fig. Figures 5 to 7 show the ballast body 10 being formed from a first material 5, while the float 9 is formed from a second material 6. Both components 7 and 8 are made of plastic. The first material 5 forming the ballast body 10 has a first density ρ1 that is greater than the density ρ2 of the second material forming the float 9. The second density ρ2 is less than the density of blood serum 13, and the first density ρ1 is greater than the density of blood plasma 12. The total density ρ GesamtThe density of the solid separator 1 lies between the density of the blood plasma 12 and the density of the blood serum 13.

[0027] Furthermore, the second material 6 is soft and pliable and exhibits resilience. The first material 5, on the other hand, has no resilience and is elastic.

[0028] The ballast body 10 has a first, essentially 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 each other. On one 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 shown from the Fig. 4 evident - hollow and has an inner tenon 17 projecting into a cavity 27. The length 18 of the inner tenon 17 is reduced compared to the length 26 of the cavity 27 of the tenon 15, as can be seen in particular from the Fig. 6 is evident.

[0029] The float 9 is funnel-shaped and has a sealing area 28 at its upper end. A circumferential sealing rim 29 is formed on the sealing area 28 to form a continuous seal against the inner side of the blood collection tube 20. The outer diameter 30 of the sealing rim 29 is larger than the inner diameter 31 of the blood collection tube 20, so that the solid separator 1, when in its initial position, which is particularly relevant in Fig. As shown in Figure 1, the sealing edge 29 is held in the blood collection tube 20 by static friction against the wall 52. Furthermore, the float 9 has a through-opening 16 that extends through the float 9 along a longitudinal axis 32 of the float 9.

[0030] The through-opening 16 of the float 9 and the pin 15 of the ballast 10 together form a valve 14 for opening or closing the through-opening 16 in the float 9. The pin 15 of the ballast 10 is in a rest position of the solid separator 1, which is in Fig. 5 is shown, inserted into the through-opening 16 of the float 9 and seals it liquid-tight.

[0031] The float 9 and the ballast 10 are movable relative to each other. When centrifugal force acts on the solid-state separator 1, the ballast 10 experiences a greater force than the float 9, causing the ballast 10 to move relative to the float 9. This movement moves the pin 15 out of the through-opening 16. To prevent the two components 7 and 8 from separating completely and to ensure that the valve 14 closes automatically when the centrifugal force is removed, the float 9 of the solid-state separator 1 has a connecting element 33. The connecting element 33 has four lobe-shaped sections 48, which are formed from the second material 6 and are arranged at 90° angles to each other on a lower surface 29 of the float 9.The lobe-shaped sections 48 are elastically deformable and form a force-transmitting connection between the float 9 and the ballast 10, so that – starting from a rest state of the solid-state separator 1 – a force is required to overcome a restoring force defined by the connecting element 33 for any relative movement between the float 9 and the ballast 10. This force is provided by the centrifugal force acting on the solid-state separator 1.

[0032] Furthermore, the connecting element 33 overlaps the ballast body 10 in an overlap area 35. In the overlap area 35, the solid separator 1 has grooves 23 in the first section 21 of the ballast body 10. The connecting element 33 also has four retaining brackets 36 that engage the ballast body 10. The grooves 23 serve to receive the retaining brackets 36. The retaining brackets 36 converge on an underside 51 of the solid separator 10. The retaining brackets 36 are also made of the second material 6.

[0033] The connecting element 33 is also connected to the ballast body 10 at four anchoring points 38 by means of four anchoring elements 24 such that, in the event of relative movement, in particular as a result of a centrifugal force acting on the solid separator 1, the respective retaining bracket 36 of the connecting element 33 is prevented from deforming in the overlap area 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 flap-shaped sections 48 of the connecting element 33 outside the overlap area 35.

[0034] The float 9 and the connecting element 33 are made of the same material and are formed in one piece. The flap-shaped sections 48 of the connecting element 33 connect the retaining brackets 36 integrally to the sealing area 28 of the solid 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 flap-shaped sections 48 of the connecting element 33. In other words, the retaining brackets 6 are thicker than the flap-shaped sections 48 of the connecting element 33.

[0035] The solid separator 1, under the influence of a centrifugal force, is in the Fig. Figure 7 shows that during the centrifugation process, the centrifugal force causes the ballast body 10 to separate from the float body 9. The connecting element 33 prevents the ballast body 10 from completely separating from the float body 9. In this process, the connecting element 33 is elastically deformed in the area outside the overlap area 35, specifically in the area of ​​the flap-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.

[0036] At the same time, however, the ballast body 10 is moved away from the float body 9 in such a way that contact between the lobe-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 centrifugation process, as can be seen in particular from Fig. As can be seen in Figure 7. The contact between the flap-shaped sections 48 of the connecting element 33 and the anchoring elements 24 is also at least partially broken on one side. However, due to the one-piece connection between the flap-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.

[0037] The sealing area 28 of the float 9 is compressed when inserted into the blood collection tube 20 in such a way that the solid separator 1 can be accommodated in the blood collection tube 20. For this purpose, the solid separator 1 is moved with its longitudinal axis 39 relative to a starting position that is in the Fig. Figures 2 to 7 show the solid separator rotated by 90° so that the longitudinal axis 39 of the solid separator 1 is aligned perpendicular to a longitudinal axis 40 of the blood collection tube 20. An inserted state of the solid separator 1 is shown in the Fig. Figure 8 shows that after inserting the solid separator 1 into the blood collection tube 20, the patient's blood 11 can be drawn into the blood collection tube 20. The blood collection tube 20 with the solid separator 1 is then placed in 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 8. Fig. 9 shown.

[0038] Due to a centrifugal force acting on the solid separator 1, the solid separator 1 overcomes static friction. The solid separator 1 moves towards a base 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 its higher density compared to the density of the float 9. The solid separator 1 aligns itself such that its longitudinal axis 39 is parallel to the longitudinal axis 40 of the blood collection tube 20. In this state, the sealing rim 29 seals against the inside of the blood collection tube 20.

[0039] Simultaneously, during centrifugation, the components 2 and 3 of the body fluid 4 to be separated are also separated from each other due to their density differences. The separation of components 2 and 3 is made possible by the presence of the through-opening 16 in the float 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 and 3 of the blood 11, as can be seen in particular from Fig. 10. In this way, the components 2, 3 can arrange themselves above and below the solid separator 1 depending on their density.

[0040] Since the total density ρ GesamtSince the density of the solid separator 1 lies between the density of the first component 2 and the density of the second component 3 of the body fluid 4, the solid separator 1, after the separation of the two components 2, 3, aligns itself at a boundary 43 between the two components 2, 3, as shown by the Fig. As can be seen in section 10. The total density ρ is... GesamtThe position of the solid separator 1 is preferably selected such that the lowest point of the through-opening 16 of the solid separator 1 is located above the boundary 43 between the two components 2, 3. For example, the distance between the lowest point and the boundary 43 can be approximately 1 mm. In this way, a safety margin can be selected that prevents the second component 3 from aligning 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 the loss of sample material, in particular component 2, is minimized when component 2 is poured out of the blood collection tube 20 after the centrifugation process has ended.

[0041] The different stages of the solid separator 1 during its movement are shown in the Fig. Figure 9 shows that 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 then reinserted into the through-opening 16. In this way, the components 2 and 3 of the body fluid 4 remain separated from each other even after the centrifugal force ceases.

[0042] The restoring force of the lobe-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 decreases, and does not only move back into the through-opening 16 when the centrifugal force completely ceases. Such a condition is in the Fig. 7 shown.

[0043] The fact that the solid separator 1 also aligns itself at the boundary 43 between the components 2, 3 even with fluctuations in the density ρ1, ρ2 of the two materials used is ensured during the manufacture of the solid separator 1 by means of the inventive method for adjusting the total density ρ Gesamt The solid separator 1 is ensured.

[0044] The total density ρ Gesamt The solid separator 1 is calculated as follows: PTotal=m1+m2V1+V2=ρ1⋅V1+ρ2⋅V2V1+V2

[0045] Due to fluctuations in the density ρ1 of the first material 5 and / or the density ρ2 of the second material 6, a deviation in the value of the total density ρ may occur. Gesamt of the solid 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 separator 1. To avoid this, the densities ρ1, ρ2 of the two materials 5, 6 are determined in a first step and compared with their respective target densities. The target densities are those densities that materials 5, 6 must have so that the value of the total density ρ Gesamt The solid separator 1 is optimally adjusted. Depending on the material 5, 6 whose density ρ1, ρ2 deviates from the target density, the volume V1, V2 of the first material 5 and / or the second material 6 is adjusted. The adjustment of the volume V1, V2 is achieved, for example, by lengthening or shortening the inner pin 17 of the pin 15 of the ballast body 10 of the solid separator 1, as shown in the Fig. 12 is shown.

[0046] In the event that the density ρ1 of the first material 5, which forms the ballast body 10, is reduced compared to the target density, the value of the total density ρ Gesamtby extending the inner pin 17. Conversely, the value of the total density ρ can be adjusted. Gesamt The density ρ1 of the first material 5 can be adjusted by shortening the inner pin 17 if it is higher than the target density. The volume V1 of the first material 5 used to form the solid separator 1 can be determined as follows: V1=V2(ρtotal−ρ2)(ρ1−ρtotal)

[0047] The solid separator 1 is used as in Fig. Figure 13 shows the component being manufactured using the injection molding process according to the invention. In a first process step, the first material 5 is injected into a first mold 55, forming a first component 7. This first component 7 later forms the ballast body 10 of the solid 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 its upper side with an annular recess 49 – as shown in particular in Figure 13. Fig. 4 is clearly visible - the recess 49 is closed at three connection points 50 between the inner pin 17 and the pin 15.

[0048] After the first material 5 has hardened, the mold 55 is transferred from a first mold position to a second mold position. The interior enclosed by the mold 55 in the second mold position essentially corresponds to the final shape of the solid separator 1. In a second process step, the second material 6 is then introduced into the mold 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 from it. The second material 6 flows as in the Fig. 14 and Fig. Figure 15 shows the flow of the second material 6 from the annular recess 49 on the upper surface 45 of the first component 7 through the cavity 44 in the pin 15 to an underside 46 of the first component 7. The underside 46 forms a reversal zone 47, from which the second material 6 flows around an outer surface of the first component 7 up to an upper surface 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 then also cured. After curing of the second material 6, the two components 7, 8 are movable relative to each other, whereby complete removal of the float 9 from the ballast body 10 is prevented due to the force-fit connection of the connecting element 33 in the anchoring points 38.

[0049] In order to adjust the length 18 of the inner pin 17 during the manufacturing process and thus change the 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 mold 55, as is shown in particular from the Fig. As can be seen in Figure 12. The tool 54 limits the flow of the first material 5 towards a bottom surface 34 of the float 9. In this way, the length 18 of the inner pin 17 can be adjusted. After hardening and insertion of the first component 7 into the second mold 55, or after transferring the first mold 55 into the second mold position, the tool 54 can be removed.

[0050] The solid-state separator 1 produced by means of the inventive method can thus be manufactured with a constant total density ρ Gesamt The internal pins 17, of varying lengths, are as shown in the Fig. 14 and Fig. 15 is evident. In the Fig. Figure 14 shows a solid separator 1 having a short inner pin 17, whereas the one in the Fig. 15 shown solid separator 1 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. Reference symbol list 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 pins 18 Length of the inner pin 19 sample containers 20 blood collection tubes 21 First Section 22 Second Section 23 Nut 24 anchoring element 25 Bridge 26 Length of the cone 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 Embedding area 36 retaining brackets 37 Underside of the ballast body 38 Anchorage point 39 Longitudinal axis of the solid 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 side of the first component 46 Underside of the first component 47 Reversal range Section 48 49 recess 50 liaison point 51 Underside of the solid separator 52 wall 53 Direction of rotation 54 tools 55 Forming tool ρ1 first density ρ2 second density ρ Gesamt Total density V1 first volume V2 second volume QUOTES INCLUDED IN THE DESCRIPTION

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

[0000] EP 232 6421 B1

[0005]

Claims

[1] Method for producing a solid-state separator (1) using the injection molding process with the following process steps: a) injecting a first material (5) into a mold (55) to form a first component (7). b) injecting a second material (6) into the same or a further mold (55) to form a second component (8), wherein the second material (6) flows at least partially through a cavity (27) of the first component (5) without forming a material connection with the first component (5). [2] Method according to claim 1, characterized by that the second material (6) is injected into the mold (55) starting from an upper side of the first component (45) through the cavity (27) of the first component (7) to an underside of the first component (46). [3] Method according to claim 2, characterized bythat the second material (6), after reaching a reversal region (47) of the first component (7), flows from the reversal region (47) around at least a part of an outer side of the first component (7) up to the upper side of the first component (45), wherein the reversal region (47) is preferably an underside of the first component (46). [4] Method according to one of claims 1 to 3, characterized by that the second material (6) at least partially fills the cavity (27) of the first component (7) in a final state of the solid-state separator (1). [5] Method according to one of the preceding claims, characterized by that the first material (5) is a material without elastic properties and the second material (6) is a thermoplastic elastomer. [6] Method according to one of the preceding claims, that the first component (5) at least to a predominant extent constitutes a ballast body (10) of the solid-state separator (1) and / or the second component (6) at least to a predominant extent constitutes a floating body (9) of the solid-state separator (1). [7] Method according to claim 6, characterized by in that the ballast body (10) has a pin (15), wherein the pin (15) is formed in method step a) and has the cavity (27) so that the second material (6) flows through the cavity (27) in the pin (15) during the production of the solid-state separator (1). [8] Method according to claim 6 or 7, characterized by that the floating body (9) has a through-opening (16) into which the pin (15) of the ballast body (10) can be inserted, wherein the through-opening (16) of the floating body (9) and the pin (15) of the ballast body (10) together form a valve (14). [9] Method according to one of the preceding claims, characterized by that the components (7, 8) are movable relative to one another in a final state. [10] Method according to one of the preceding claims, characterized by that the molding tool (55) assumes a first molding position in process step a) and is transferred into a second molding position in process step b). [11] Method according to claim 10, characterized by that an interior space enclosed by the molding tool (55) in the first molding position substantially corresponds to a final shape of the ballast body (10) and that an interior space enclosed by the molding tool (55) in the second molding position substantially corresponds to a final shape of the solid-state separator (1).

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