Method for producing a separator for solid particles
The method improves the production of solid-state separators by injecting a second material through the cavity of the first component, allowing for easier and quicker manufacturing and effective separation of body fluid components during centrifugation, addressing inefficiencies in existing injection molding processes.
Patent Information
- Application Number
- PCT/EP2024/070209
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-07-19
- Filing Date
- 2024-07-17
- Publication Date
- 2025-01-23
AI Technical Summary
Existing methods for producing solid-state separators using injection molding are inefficient, particularly due to the need to remove the ballast body from the mold before injecting the floating body, which disrupts the molding process.
A method involving two process steps where a first material is injected into a mold to form a component with a cavity, and a second material is injected through this cavity without forming a cohesive connection, allowing the second material to flow around and enclose the first component, enabling easier and quicker production without the need for transferring the first component to another mold.
This approach allows for the production of solid-state separators with movable components that do not stick together, facilitating easier separation of body fluid components during centrifugation and maintaining separation after centrifugal force is lost, enhancing the efficiency and ease of manufacturing.
Smart Images

Figure EP2024070209_23012025_PF_FP_ABST
Abstract
Description
Process for producing a solid-state separator Description
[0001] The present application relates to a method for producing a solid-state 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 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, with the two materials being separated from one another within the solid-state separator. A solid-state separator is typically used in conjunction with a centrifuge to separate the components of a body fluid. The solid-state separator is placed in a sample container, typically a tube, along with a body fluid, and then centrifuged. Due to the centrifugal force acting on the body fluid and the different densities of the two components of the body fluid, the components separate from one another. 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 separator lies between the densities of the two components, so that the solid separator positions itself between the two components during centrifugation. The solid separator is typically designed in such a way that an exchange of components is possible during the centrifugation process, but is prevented when the centrifugal force is removed. In this way, 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.
[0004] Since solid-state separators are usually only used once, solid-state separators are typically made of plastic and are therefore usually manufactured using the injection molding process. State of the art
[0005] Numerous methods for producing solid-state separators using injection molding are known from the prior art. For example, reference is made to European patent EP 232 6421 B1, which describes a solid-state separator comprising a ballast body and a float. It is described that a first subassembly of the solid-state separator, comprising a pierceable head and the float, and a second subassembly of the solid-state separator, comprising a bellows and the ballast body, are separately molded or extruded and subsequently assembled. Alternatively, the ballast body can be formed first, followed by the float, with the float being integrally molded onto the ballast body.
[0006] Another method for manufacturing solid-state separators is described in German patent application DE 102019 121 723 A1. The method described therein proposes producing the solid-state separator using a two-component injection molding process. For this purpose, the ballast body can first be manufactured using a first injection mold and then placed in a second injection mold. This is then overmolded to form the floating body. However, it has proven problematic that the ballast body must be removed from the first injection mold prior to overmold formation. The injection molding process must therefore be interrupted. Task
[0007] The object of the present invention is to provide an alternative method for producing a solid-state separator. Solution
[0008] Based on the method for producing a solid-state separator mentioned above, the above-mentioned object is achieved by a method comprising at least two steps. In a first step, a first material is injected into a mold. In this process, a first component is formed. The first component has at least one cavity. In a second step, A second material is injected into the same mold or another mold. This creates a second component. During injection of the second material, the second material flows at least partially through the cavity of the first component without forming a material bond with the first material.
[0009] For the purposes of this application, a "component" is understood to mean a part of the solid-state separator. The component does not necessarily have to be separate from another component or other elements of the solid-state separator. Rather, the component can also be integrally connected to other components and / or elements of the solid-state separator.
[0010] The method according to the invention has many advantages. A particular advantage of the method is that the second component is produced while the first component is still present. Although the two components are formed at different times, the method is improved over the prior art because the second material can flow particularly easily through the cavity in the first component into the mold. Only transferring the first component into a second mold may be necessary. At the same time, it is ensured that the two components remain movable relative to one another even after the materials have hardened, since the components do not form a material bond with one another.
[0011] If the second material is injected into the same mold, it is not necessary to remove the first component from the mold - in contrast to the method described in the prior art. 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 transfer the mold into a mold position different from the first mold position after the first component has been formed. However, even in such a case, replacing the mold is not necessary. In this way, the solid-state separator can be manufactured particularly easily and quickly.
[0012] Preferably, the two materials used to produce the solid-state 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.
[0013] According to a preferred embodiment of the invention, the second material is introduced from a top side of the first component through the cavity of the first component to an underside of the first component into the mold. In a particularly preferred manner, it can be provided that the first material first hardens completely before the second material is injected through the cavity of the first component into the mold. The first component is already located in the mold when the second material is injected. If the second material is injected into the same mold as the first material, the second material can be fed particularly easily through the cavity of the first component into the mold.
[0014] It is preferably further provided that, after reaching a reversal region of the first component, the second material flows from the reversal region around at least part of an outer side of the first component up to the upper side of the first component, wherein the reversal region 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 the first component. The first component is preferably completely enclosed by the second material, since the second material flows around both the cavity and an outer side of the first material. Alternatively, it is also conceivable for the second material not to flow around the first component completely, but only partially, preferably in predetermined sections.
[0015] According to a further preferred embodiment of the invention, the second material at least partially fills the cavity of the first component in a final state of the solid-state separator. The second material therefore not only flows through the cavity in the first component, but also remains at least partially in the cavity after completion of the second component. Likewise, it can also be provided that the second material completely fills the cavity of the first component in the final state of the solid-state separator.
[0016] A preferred embodiment further provides that the first material is a thermoplastic and the second material is a thermoplastic elastomer. The use of the above materials has proven particularly advantageous for the use of the injection molding process for producing a solid-state separator, since they do not stick to one another. Preferably, it can be provided that the first material has a higher melting point than the second material. It has also been found that a viscosity of the second material should preferably be adjusted so that it can be ensured that the second material can fill cavities in the mold via narrow cross-sections and complex or long flow paths in the mold can be filled as completely as possible.
[0017] An advantageous embodiment of the invention provides that the first component at least predominantly constitutes a ballast body of the solid-state separator and / or the second component at least predominantly constitutes a floating body of the solid-state separator. In this case, it can preferably be provided that the second material forms the floating body of the solid-state separator and further elements of the solid-state separator, while the first material forms the ballast body. The further elements of the solid-state separator can be formed integrally with the floating body. The floating body is only differentiated from the other elements by its function. There does not necessarily have to be a difference with regard to the material used.
[0018] In the event that the first component constitutes the ballast body and the second component constitutes the floating body, it may be preferable to adjust a viscosity and a melting point of the materials used for the components accordingly.
[0019] Preferably, the first material—and thus also the ballast body—can have a higher density than the second material. A centrifugal force acting on the ballast body during a centrifugation process for separating components of a body fluid is thus greater than the force acting on the floating body. As a result, the floating body and the ballast body move away from each other.
[0020] 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 method step and has the cavity, so that the second material flows through the cavity in the pin during production of the solid-state separator. The pin itself can in turn have an inner pin that protrudes into the cavity. The second material can preferably be introduced into the cavity from an upper side of the pin through recesses on the upper side, flowing around the inner pin and completely surrounding it after completion of the second component.
[0021] Preferably, the floating body may have a through-opening into which the pin of the ballast body can be inserted, wherein the through-opening of the floating body and the pin of the ballast body together form a valve. Preferably, it may be provided that the ballast body opens when exposed to the Centrifugal force removes the solids from the float due to the different densities of the float and the ballast. During this process, the pin is removed from the through-opening. In this case, it can be particularly advantageous if the pin is assigned to 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, in this case it is particularly preferred if an external shape of the solids separator is adapted such that the solids separator, when at rest and after separation of the components, lies in sealing contact with a wall of a sample container containing the body fluid to be separated. During the centrifugation process, it can be provided that the solids separator can move within the sample container in order to be able to arrange itself between the components of the body fluid to be separated.The replacement of components is particularly possible through the through opening.
[0022] A further embodiment of the invention provides that the components are movable relative to one another in a final state. Relative movement of the two components is enabled by the fact that the components do not form a material connection. In this case, the solid-state separator can comprise, in addition to the floating body and the ballast body, at least one elastically deformable connecting element, which forms a force-transmitting connection between the floating body and the ballast body, so that—starting from a restorative state—a force is required for a relative movement between the floating body and the ballast body to overcome a restoring force defined by the connecting element.Due to the elastic deformability of the connecting element, it also ensures that the relative movement is reversed once the force is removed, so that the float and the ballast body return to the corresponding positions they occupied in the initial rest state. If the pin of the ballast body forms a valve together with the cavity of the float, it can be provided that the pin is inserted into the cavity in the rest state. Under the action of the force, the pin is removed from the cavity and the valve opens. Once the force is removed, the connecting element inserts the pin back into the cavity of the float body, closing the valve again.
[0023] Furthermore, it may be particularly preferred if the mold assumes a first molding position in the first process step and is transferred to a second molding position in the second process step. In this way, a single molding tool The mold then only needs to be adjusted in its mold position.
[0024] An advantageous embodiment of the invention provides that an interior space enclosed by the molding tool in the first molding position substantially corresponds to a final shape of the ballast body and that an interior space enclosed by the molding tool in the second molding position substantially corresponds to a final shape of the solid-state 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 which the molding tool encloses in a first molding position. The first material therefore only needs to be introduced into the molding tool. Preferably, after the first material has hardened, the molding tool is transferred to a second molding position which is larger in volume than the first molding position. The second material is then introduced into the molding tool through the cavity in the first component.The interior space enclosed by the mold in the second molding position corresponds to the final shape of the solid-state separator. After the second material has cured, the solid-state separator is finished, and only the mold needs to be removed from the solid-state separator. Advantageously, the use of a second mold is not necessary. Production can therefore be carried out particularly easily and quickly by transferring the mold between the molding positions. Examples of implementation
[0025] 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 Figure 1. Fig. 3: A perspective view of a ballast body of the solid-state separator from Figure 1. Fig. 4: Another perspective view of the ballast body from Figure 3 in a vertical section. Fig. 5: A perspective view of the solid-state separator from Figure 1. Fig. 6: A vertical section through the solid-state separator from Figure 1. Fig. 7: As in Figure 6, with a centrifugal force acting on the solid separator. Fig. 8: A horizontal section through a sample container, where the Solid state separator from Figure 1 is in an initial position in the sample container. Fig. 9: As Figure 1, showing different stages of movement of the Solid state separator are shown. Fig. 10: A detailed view of the solid state separator during a Centrifugation process. Fig. 11 : The sample container with the solid state separator from Figure 1 in a Final state of the solid separator after the centrifugation process. Fig. 12: The ballast body of the solid state separator from Figure 1 during a manufacturing process. Fig. 13: The solid-state separator from Figure 1 during a manufacturing process. Fig. 14: Another view of the solid state separator from Figure 1 during a manufacturing process. Fig. 15: Another solid state separator during a manufacturing process.
[0026] A solid-state separator 1 manufactured according to the method of the invention is shown in Figures 1 to 15. The solid-state separator 1 serves to separate components 2, 3 of a body fluid 4 with different densities from one another during a centrifugation process. The centrifugation process is an essential component in the pre-analytics of blood 11 for medical purposes. For this purpose, the blood 11 is taken from a patient and introduced into a sample container 19 in the form of a blood collection tube 20. As can be seen from Figure 1, the solid-state separator 1, which was previously inserted into the blood collection tube 20, is already located in 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.
[0027] The solid-state separator 1 comprises two relatively movable, interconnected components 7, 8: a floating body 9 and a ballast body 10. The floating body 9 is shown in Figure 2, the ballast body 10 in Figures 3 and 4. An assembled state of the solid-state separator 1 is shown in Figures 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 p1 that is greater than a density p2 of the second material forming the floating body 9. The second density p2 is less than the density of the blood serum 13, and the first density p1 is greater than the density of the blood plasma 12. The total density p of the solid-state separator 1 lies between the density of the blood plasma 12 and the density of the blood serum 13.
[0028] 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.
[0029] The ballast body 10 has a first, substantially hemispherical section 21 and a second section 22, the latter being in the form of a pin 15. The first section 21 of the ballast body 10 is provided with four grooves 23, which are arranged at an angle of 90° to one another. On an upper side, the first section 21 is provided with four connecting elements 24 in the form of webs 25. The webs 25 connect the areas of the first section 21 of the ballast body 10 that do not have a groove 23. The pin 15 of the ballast body 10 is—as can be seen from Figure 4—hollow and has an inner pin 17 projecting into a cavity 27. A length 18 of the inner pin 17 is reduced compared to a length 26 of the cavity 27 of the pin 15, as can be seen in particular from Figure 6.
[0030] The floating body 9 is shaped like a funnel and has a sealing region 28 at its upper end. A circumferential sealing edge 29 is formed on the sealing region 28 for a circumferentially sealing engagement with an inner side of the blood collection tube 20. An outer diameter 30 of the sealing edge 29 is larger than an inner diameter 31 of the blood collection tube 20, so that the solid-state separator 1, when in an initial position, which is shown in particular in Figure 1, is held in the blood collection tube 20 due to static friction of the sealing edge 29 against the wall 52. Furthermore, the floating body 9 has a through-opening 16 that extends through the floating body 9 along a longitudinal axis 32 of the floating body 9.
[0031] 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 is shown in Figure 5, in the through opening 16 of the float 9 and closes it liquid-tight.
[0032] 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.
[0033] 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.
[0034] 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.
[0035] The floating body 9 and the connecting element 33 are made of the same material and are formed as a single piece. The tab-shaped sections 48 of the connecting element 33 connect the retaining brackets 36 as a single piece to the sealing area 28 of the solid-state separator 1, as is particularly clearly visible in Figure 2. It is also evident that a cross-sectional area of the retaining brackets 36 exceeds a cross-sectional area of the tab-shaped sections 48 of the connecting element 33. In other words, the retaining brackets 6 are thicker than the tab-shaped sections 48 of the connecting element 33.
[0036] The solid-state separator 1 under the influence of a centrifugal force is shown in Figure 7. During the centrifugation process, the centrifugal force causes the ballast body 10 to separate from the floating body 9. The connecting element 33 ensures that the ballast body 10 does not completely separate from the floating body 9. In this case, the connecting element 33 is elastically deformed in the area outside the overlap 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.
[0037] 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 for the duration of the centrifugation process, as can be seen in particular from Figure 7. The contact between the tab-shaped sections 48 of the connecting element 33 and the anchoring elements 24 is also at least partially eliminated on one side. However, due to the one-piece connection between the tab-shaped sections 48 of the connecting element 33 and the retaining brackets 36 of the connecting element 33, these remain in contact even under the influence of centrifugal force.
[0038] The sealing area 28 of the floating body 9 is squeezed upon insertion into the blood collection tube 20 such that the solid-state separator 1 can be accommodated in the blood collection tube 20. For this purpose, the solid-state separator 1 is rotated with its longitudinal axis 39 by 90° relative to an initial position shown in Figures 2 to 7, so that the longitudinal axis 39 of the solid-state separator 1 is aligned perpendicular to a longitudinal axis 40 of the blood collection tube 20. An inserted state of the solid-state separator 1 is shown in Figure 8. After inserting the solid-state separator 1 into the blood collection tube 20, the patient's blood 11 can be poured into the blood collection tube 20. The blood collection tube is then 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 Figure 9.
[0039] 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.
[0040] At the same time, during centrifugation, the components 2, 3 of the body fluid 4 to be separated are also separated from one another due to differences in density. The separation of the components 2, 3 is made possible by the presence of the through-opening 16 in the floating body 9. During centrifugation, the pin 15 of the ballast body 10 is moved out of the through-opening 16, thus opening a flow path 42 for the components 2, 3 of the blood 11, as can be seen particularly in Figure 10. In this way, the components 2, 3 can be arranged above and below the solid-state separator 1 depending on their density.
[0041] Since the total density pcesamt of the solid separator 1 lies between a density of the first component 2 and a density of the second component 3 of the body fluid 4, the solid separator 1 is arranged at a boundary 43 between the two components 2, 3 after the separation of the two components 2, 3, as can be seen from Figure 10. The total density pcesamt of the solid separator 1 is preferably selected such that a lowest point of the through-opening 16 of the solid separator 1 is arranged above the boundary 43 between the two components 2, 3. For example, it can be provided that a distance between the lowest point and the boundary 43 is approximately 1 mm. In this way, on the one hand, a safety distance can be selected which prevents the second component 3 from arranging itself above the solid separator 1 when the centrifugal force decreases.At the same time, the distance is chosen to be as small as possible so that a loss of sample material, in particular of component 2, is minimized when component 2 is poured out of the blood collection tube 20 after the centrifugation process has ended.
[0042] The various stages of the solid-state separator 1 during its movement are shown in Figure 9. After the centrifugal force ceases due to the termination of the centrifugation process, the connecting element 33 closes the valve 14. The pin 15 of the ballast body 10 is reinserted into the through-opening 16. In this way, the components 2, 3 of the body fluid 4 remain separated from each other even after the centrifugal force ceases.
[0043] The restoring force of the tab-shaped sections 48 of the connecting element 33 is selected such that the pin 15 of the ballast body 10 is inserted back into the through-opening 16 as soon as the centrifugal force decreases, and does not move back into the through-opening 16 until the centrifugal force is completely eliminated. Such a state is shown in Figure 7.
[0044] 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 pi, p2 of the two materials used is ensured during the production of the solid-state separator 1 by means of the method according to the invention for adjusting the total density pcesamt of the solid-state separator 1.
[0045] The total density pcesamt of the solid separator 1 is calculated as follows:
[0046] Due to fluctuations in the density pi of the first material 5 and / or the density p2 of the second material 6, a deviation of the value of the total density pcesamt of the solid-state separator 1 from a target value of the total density pcesamt of the solid-state separator 1 required for optimal separation of the components 2, 3 of the blood 11 may occur. To avoid this, the densities pi, p2 of the two materials 5, 6 are determined in a first step and compared with the respective target densities. The target densities are the densities that the materials 5, 6 must have so that the value of the total density pcesamt of the solid-state separator 1 is optimally adjusted. Depending on the material 5, 6 whose density pi, p2 deviates from the target density, the volume Vi, V2 of the first material 5 and / or the second material 6 used is adjusted.The adjustment of the volume Vi, V2 is carried out, for example, by an extension or shortening of the inner pin 17 of the pin 15 of the ballast body 10 of the solid-state separator 1, as shown in Figure 12.
[0047] If the density pi of the first material 5 forming the ballast body 10 is reduced compared to the target density, the value of the total density pcesamt can be adjusted by lengthening the inner pin 17. Conversely, the value of the total density pcesamt can be adjusted by shortening the inner pin 17 if the density pi of the first material 5 is increased compared to the target density. The volume Vi of the first material 5 used to form the solid-state separator 1 can be determined as follows:
[0048] The solid-state separator 1 is manufactured, as shown in Figure 13, 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, 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 one another, so that a cavity 44 is formed in the pin 17. Furthermore, the pin 15 is provided on an upper side with an annular recess 49 - as can be clearly seen in particular from Figure 4 - wherein the recess 49 is closed at three connection points 50 between the inner pin 17 and the pin 15.
[0049] After the first material 5 has hardened, the molding tool 55 is transferred from a first molding position to a second molding position. An interior space enclosed by the molding tool 55 in the second molding position essentially corresponds to a final shape of the solid-state separator 1. Finally, in a second process step, the second material 6 is introduced into the molding tool 55 through the annular recess 49 of the ballast body 10, without forming a material bond with the first material 5 or the first component 7 formed therefrom. As shown in Figures 14 and 15, the second material 6 flows from the annular recess 49 on the upper side 45 of the first component 7 through the cavity 44 in the pin 15 to a lower side 46 of the first component 7.The underside 46 forms a reversal region 47, from which the second material 6 flows around an outer side of the first component 7 up to a top side 45 of the first component 7. In a final state, the second material 6 completely fills the cavity 44 that 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, whereby a complete removal of the floating body 9 from the. Ballast body 10 is prevented due to the force-locking connection of the connecting element 33 in the anchoring points 38.
[0050] In order to be able to adjust a length 18 of the inner pin 17 during the manufacturing process and thus change a volume of the first component 7, a further tool 54 can be used, which is inserted before the first material 5 is introduced into the molding tool 55, as can be seen in particular from Figure 12. The tool 54 limits a flow of the first material 5 in the direction of an underside 34 of the floating body 9. In this way, the inner pin 17 can be adjusted in its length 18. After curing and insertion of the first component 7 into the second molding tool 55 or after transferring the first molding tool 55 into the second molding position, the tool 54 can be removed.
[0051] The solid-state separator 1 produced by the method according to the invention can thus have inner pins 17 of different lengths while maintaining a constant overall density, as can be seen in Figures 14 and 15. Figure 14 shows a solid-state separator 1 having a short inner pin 17, while the solid-state separator 1 shown in Figure 15 has a significantly longer inner pin 17, with a length 18 of the inner pin 17 exceeding the length of the pin 15 and penetrating into the first section 21 of the ballast body 10. List of reference symbols 1 solid-state separator 2 first component 3 second component 4 Body fluid 5 first material 6 second material 7 first component 8 second component 9 floats 10 ballast bodies 11 Blood 12 Blood plasma 13 Blood serum 14 Valve 15 cones 16 passage opening 17 inner tenons 18 Length of the inner tenon 19 sample containers 20 blood collection tubes 21 First Section 22 Second Section 23 grooves 24 Anchoring element 25 jetty 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 Embedding 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 Pi first density p2 second density pTotal total density Vi first volume v2 second volume
Claims
Claims 1. A method for producing a solid-state separator (1) using the injection molding process, comprising the following method 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-to-material connection with the first component (5).
2. Method according to claim 1, characterized in 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 in that 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 in 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 in 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, characterized in 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. The method according to claim 6, characterized 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 in that the floating body (9) has a through-opening (16) into which the pin (15) of the ballast body (10) can be inserted, the through-opening (16) of the floating body (9) and the pin (15) of the ballast body (10) together forming a valve (14).
9. Method according to one of the preceding claims, characterized in 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 in that the molding tool (55) assumes a first molding position in method step a) and is transferred into a second molding position in method step b).
11. The method according to claim 10, characterized in 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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