CN117545543A - 透析器 - Google Patents

透析器 Download PDF

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Publication number
CN117545543A
CN117545543A CN202280027321.3A CN202280027321A CN117545543A CN 117545543 A CN117545543 A CN 117545543A CN 202280027321 A CN202280027321 A CN 202280027321A CN 117545543 A CN117545543 A CN 117545543A
Authority
CN
China
Prior art keywords
housing
end cap
filter device
sealing
flow space
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202280027321.3A
Other languages
English (en)
Inventor
P·加斯陶尔
F·库格尔曼
M·保罗
A·鲁芬
T·法伊特
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of CN117545543A publication Critical patent/CN117545543A/zh
Pending legal-status Critical Current

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24—Dialysis ; Membrane extraction
    • B01D61/243—Dialysis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/24—Dialysis ; Membrane extraction
    • B01D61/28—Apparatus therefor
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D63/00—Apparatus in general for separation processes using semi-permeable membranes
    • B01D63/02—Hollow fibre modules
    • B01D63/021—Manufacturing thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D71/00—Semi-permeable membranes for separation processes or apparatus characterised by the material; Manufacturing processes specially adapted therefor
    • B01D71/06—Organic material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
    • B29C65/20—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools with direct contact, e.g. using "mirror"
    • B29C65/2007—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools with direct contact, e.g. using "mirror" characterised by the type of welding mirror
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
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    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/112—Single lapped joints
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    • B29C66/01—General aspects dealing with the joint area or with the area to be joined
    • B29C66/05—Particular design of joint configurations
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    • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
    • B29C66/114—Single butt joints
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    • B29C66/122—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section
    • B29C66/1222—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a lapped joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C66/1224—Joint cross-sections combining only two joint-segments, i.e. one of the parts to be joined comprising only two joint-segments in the joint cross-section comprising at least a butt joint-segment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/13—Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
    • B29C66/131—Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
    • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
    • B29C66/54—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
    • B29C66/542—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles joining hollow covers or hollow bottoms to open ends of container bodies
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
    • B29C66/73—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/739—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset
    • B29C66/7392—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic
    • B29C66/73921—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the intensive physical properties of the material of the parts to be joined, by the optical properties of the material of the parts to be joined, by the extensive physical properties of the parts to be joined, by the state of the material of the parts to be joined or by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of the parts to be joined being a thermoplastic or a thermoset characterised by the material of at least one of the parts being a thermoplastic characterised by the materials of both parts being thermoplastics
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/80—General aspects of machine operations or constructions and parts thereof
    • B29C66/84—Specific machine types or machines suitable for specific applications
    • B29C66/843—Machines for making separate joints at the same time in different planes; Machines for making separate joints at the same time mounted in parallel or in series
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
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    • B01D2313/04—Specific sealing means
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01D—SEPARATION
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    • B01D2313/20—Specific housing
    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B01D2313/20—Specific housing
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    • B01D2313/20—Specific housing
    • B01D2313/206—Specific housing characterised by the material
    • B01D2313/2061—Organic, e.g. polymeric material
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
    • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
    • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
    • B29C65/16—Laser beams
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
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    • B29C65/18—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using heated tools
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    • B—PERFORMING OPERATIONS; TRANSPORTING
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    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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    • B29C66/80—General aspects of machine operations or constructions and parts thereof
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    • B29C66/814—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps
    • B29C66/8141—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined
    • B29C66/81411—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat
    • B29C66/81425—General aspects of the pressing elements, i.e. the elements applying pressure on the parts to be joined in the area to be joined, e.g. the welding jaws or clamps characterised by the design of the pressing elements, e.g. of the welding jaws or clamps characterised by the surface geometry of the part of the pressing elements, e.g. welding jaws or clamps, coming into contact with the parts to be joined characterised by its cross-section, e.g. transversal or longitudinal, being non-flat being stepped, e.g. comprising a shoulder
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
    • B29C66/91921—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
    • B29C66/91931—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined
    • B29C66/91935—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to the fusion temperature or melting point of the material of one of the parts to be joined lower than said fusion temperature
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C66/00—General aspects of processes or apparatus for joining preformed parts
    • B29C66/90—Measuring or controlling the joining process
    • B29C66/91—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux
    • B29C66/919—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges
    • B29C66/9192—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams
    • B29C66/91921—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature
    • B29C66/91941—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to Tg, i.e. the glass transition temperature, of the material of one of the parts to be joined
    • B29C66/91945—Measuring or controlling the joining process by measuring or controlling the temperature, the heat or the thermal flux characterised by specific temperature, heat or thermal flux values or ranges in explicit relation to another variable, e.g. temperature diagrams in explicit relation to another temperature, e.g. to the softening temperature or softening point, to the thermal degradation temperature or to the ambient temperature in explicit relation to Tg, i.e. the glass transition temperature, of the material of one of the parts to be joined lower than said glass transition temperature
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Abstract

本发明涉及一种用于物质交换的过滤装置，其包括具有重心和两个壳体端部的管段形壳体，在所述壳体中布置有中空纤维束，所述过滤装置还包括至少一个具有第一开口和第二开口的端盖，其中，所述壳体和所述端盖形成第一密封区，第一密封区将壳体和端盖密封地连接，所述第一密封区比所述至少一个缺口距所述壳体的重心更远，在所述第一密封区和所述端盖的所述第一开口之间形成第一流体空间，经由所述第一流体空间，所述第一开口流体连接到所述第一流动空间，所述壳体和所述端盖形成第二密封区，其中，第一和第二密封区不是由密封剂形成的。

Description

透析器
技术领域
本发明涉及一种用于物质交换、特别是用于血液透析的过滤装置，所述过滤装置包括管段形壳体，所述管段形壳体具有重心并具有两个壳体端部，在所述壳体中布置有由半透膜构成的中空纤维束，所述中空纤维束的纤维腔形成第一流动空间，并且包围中空纤维束的壳体内部空间形成第二流动空间，其中，流动空间在壳体端部处通过至少一个流动空间密封件彼此分离，其中，所述壳体在至少一个端部设置有至少一个缺口，并且所述至少一个缺口被布置成比所述流动空间密封件更靠近所述壳体的重心，所述过滤装置还包括具有第一开口和第二开口的至少一个端盖。本发明还涉及一种用于制造这种过滤装置的方法。
背景技术
用于物质交换的过滤装置、更特别是用于血液透析的过滤装置，在现有技术中是已知的。在过滤技术中，特别是在血液透析中，已经发现使用半渗透中空纤维膜作为分离介质是有利的，因为它们制造简单并且显示出突出的分离特性。在血液透析中，使用聚砜基材料并添加聚乙烯吡咯烷酮用于中空纤维膜已被证明是市场主导。这样的膜在EP0168783A1中描述。收集这些膜以形成中空纤维束，并将其安装到过滤器壳体中。此后，必须进行两个流动空间的密封。在血液透析的情况下，密封发生在血液透析器的血液侧和透析液侧之间。因此，必须形成流体入口和出口，以便能够为过滤器提供相应的原始流体并移除处理过的流体。在血液透析的情况下，由半透膜或中空纤维膜束分离的两种流体被引导以逆流方式彼此经过，因此每个透析器总共需要4个流体入口。在死端过滤的情况下，两个流体入口可能就足够了。
在EP2326410A1中描述了这种用于透析的过滤器壳体。在此，相应的透析液入口和出口设置在管段形壳体上，并且相应的血液入口布置在单独的部件、端盖中。然后，利用提供的单独的弹性体密封件将端盖与过滤器壳体密封。所有部件均由热塑性塑料通过注射成型方法制成。
在DE10147907中描述了一种简化的构造，其中，在这种布置中每个端盖设置一个流体入口和一个流体出口。这种布置在制造方面表现出显著的简化，因为简化了用于管段形壳体的相应制造模具。因此，利用这些非常大的制造模具，可以至少部分地省去复杂的附加物、例如滑块。所述附加物可以更容易地容纳在较小的端盖模具中。因此，还可以避免使用过大的注射成型机。同样在DE10147907中，相应的流体空间至少部分地经由密封弹性体部件彼此连接。
然而，使用密封弹性体部件不利地导致形成死体积，并且这阻碍了物质交换的效率。死体积是不利的，特别是在血液室中，因为以过低的流动速率在体外流动或根本不流动的血液具有血小板凝结的趋势，并因此可导致透析器的堵塞。
此外，必须使用附加部件是不利的。此外，弹性体部件常常是不利的，因为这些材料可能表现出低的血液相容性。如果所述弹性体部件例如由EPDM制成，则增塑剂可能逃逸到血液中。这通常也适用于过滤技术，因为在这些应用的情况下，物质转移到滤液中也是不利的。
除了使用弹性体组分作为密封剂之外，还可以使用粘合剂。粘合剂的这种使用在制造方面是非常复杂的，并且取决于粘合剂的反应动力学也是非常耗时的。此外，粘合剂的不利成分可进入滤液或血液中。
本发明的目的
因此，本发明的目的是提供一种用于物质交换、更特别地用于血液透析的过滤装置，其防止或至少减轻现有技术的缺点。特别地，本发明的目的是提供一种用于物质交换、更特别地用于透析的特别易于制造的过滤装置，其同时减少对滤液的不利影响。在透析器的情况下，要减少对待净化的血液的不利影响。
发明内容
根据本发明，根据本发明的第一方面，所述目的通过一种用于物质交换、更特别地用于血液透析的过滤装置来实现，所述过滤装置包括具有重心和两个壳体端部的管段形壳体，在所述壳体中布置有由半透膜组成的中空纤维束，所述中空纤维束的纤维腔形成第一流动空间，并且包围中空纤维束的壳体内部空间形成第二流动空间，其中，所述流动空间在壳体端部处通过至少一个流动空间密封件彼此分离，其中，所述壳体在至少一个端部处设置有至少一个缺口，并且所述至少一个缺口被布置成比流动空间密封件更靠近壳体的重心，所述过滤装置还包括至少一个具有第一开口和第二开口的端盖，其中，壳体和至少一个端盖形成以密封方式连接壳体和端盖的第一密封区，并且其中，第一密封区比至少一个缺口更远离壳体重心，并且其中，在第一密封区和端盖的第一开口之间形成第一流体空间，第一开口经由所述第一流体空间流体连接到第一流动空间，其中，所述壳体和所述至少一个端盖形成以密封的方式连接壳体和端盖的第二密封区，并且所述第二密封区被布置成比流动空间密封件和至少一个缺口更靠近所述壳体的重心，并且其中，在第一和第二密封区与端盖的第二开口之间形成第二流体空间，端盖的第二开口经由所述第二流体空间通过至少一个缺口流体连接到第二流动空间，其中，第一和第二密封区不是由密封剂形成的。
因此，提出了一种制造特别简单的过滤装置，所述过滤装置无需使用诸如弹性体部件的密封剂或粘合剂。这可以防止或减少死体积。如果过滤装置在血液透析中操作，则减少了对血液的不利影响。特别是降低了由于血小板聚集而导致的堵塞趋势。
根据本发明的一个发展，提出了一种过滤装置，其特征在于，在第一和第二密封区中，壳体的分子与端盖的分子缠结。分子的缠结确保了端盖与壳体的特别牢固和长期稳定的连接。在第一和第二密封区中壳体的分子与端盖的分子的缠结通过在壳体连接到端盖期间确保相应表面的熔化来实现。然后使熔融的表面彼此接触，从而确保分子的缠结。
已经发现，当壳体和端盖的材料的熔点或玻璃化转变点相差小于10℃、优选小于5℃、特别优选小于3℃时是特别有利的。因此，特别牢固的连接是可能的，这同时使对滤液和血液的不利影响最小化。
在一个实施例中，可以提供的是，第一密封区比至少一个缺口和流动空间密封件更远离壳体的重心。这样的布置甚至更紧凑，并且特别地具有减小的死体积。
此外，在一个特别的实施例中，可以提供的是，管段形壳体和端盖由相同的材料组形成。如果两个部件都由一组材料制成，则密封过程基本上是便利的。如果一组材料用于两个部件，则特别有利于端盖和壳体的分子的缠结。“一组材料”表示，例如，相同材料，但颜色不同。不同的共聚物组合物也可归入一组材料。
根据本发明的一个发展，壳体和端盖的材料包括聚丙烯或聚丙烯的共聚物或聚碳酸酯、更特别是包括聚丙烯或聚丙烯的共聚物。这两种材料都具有足够高的透明度，并且适合作为热塑性材料，以确保壳体的分子与端盖的分子缠结。聚丙烯特别是特别高度适合的，因为它是特别轻的材料，同时在壳体的情况下可制造为具有小于2mm的特别小的壁厚。因此，本发明的一个实施例的特征在于，壳体的壁厚小于2mm。在另一实施例中，端盖的壁厚也小于2mm、更特别地小于1.5mm。因此，在一个特定实施例中，可以提供的是，端盖的壁厚小于壳体的壁厚，在这种情况下，两个部件优选使用基于聚丙烯的材料。
根据另一特定实施例，第一密封区等于或大于、更特别是大于管段形壳体在壳体端部处的横截面积。如果密封区等于管段形壳体在壳体端部处的横截面积，则通过最佳地利用可能的密封区来确保特别好的密封效果。在一个优选的实施例中，还可以提供的是，密封区大于管段形壳体在壳体端部处的横截面积。这可以通过配置熔化过程来确保，使得相对大量的材料被熔化，并且在随后的接合过程中进行挤压。这样的部件具有凸缘状密封区，并且这对密封效果具有有利的影响。凸缘还可以有利地使得可能的死体积进一步减少，并且这尤其在血液透析的情况下是特别期望的。
此外，在过滤装置的一个优选实施例中，在管段形壳体的相反端部处具有两个端盖，并且壳体在两个端部处设有缺口和流动空间密封件，并且缺口都被布置成比流动空间密封件更靠近壳体的重心。在两个端部处使用两个过滤器盖对于血液透析是特别有利的，因为血液和透析液由此可以被逆流地引导。这获得特别有效的血液净化。
此外，可以提供的是，壳体在至少一个端部处具有多个缺口。在血液透析的情况下，这样做的结果是使得特别均匀的透析液流动速率成为可能。因此进一步提高了尿毒症毒素的分离效率。同时，透析液中的液压以及密封区上的机械负载降低。因此，也可以实现相对高的透析液流动速率，并且这又对过滤装置的分离效率具有有利的影响。还可以提供的是，壳体在两个端部处均具有多个缺口。
一个特定实施例的特征在于，过滤装置是透析器，并且端盖的第一开口允许血液流入和血液流出，端盖的第二开口允许透析液流入和透析液流出。
根据本发明的一种发展，管段形壳体没有透析液入口和出口。这种壳体的成本效益特别高，而且可以借助简化的模具。此外，还能以特别简化的方式为壳体提供多腔模具，从而节省成本和能源。
在一个优选实施例中，流动空间密封件的材料包括环氧树脂或聚氨酯树脂作为密封材料。特别优选聚氨酯，因为当使用外径小于300μm的中空纤维时，其允许特别好的密封。在中空纤维束填充密度超过60％的情况下，材料聚氨酯由于其流动特性也是有利的。
在另一实施例中，至少一个能量引导器相应地布置在管段形壳体上和/或端盖上。当端盖和壳体通过超声波接合连接时，这种布置是优选的。这种能量引导器显著地提高了接合的密封效果，并且加速和简化了接合过程。
优选地，所述半透膜的材料包括聚砜、聚醚砜、聚乙烯吡咯烷酮、聚甲基丙烯酸甲酯、聚酰胺、聚酯、纤维素或聚丙烯腈。特别优选的材料主要由聚砜或聚醚砜和聚乙烯吡咯烷酮的混合物组成。这意味着所述材料由所述混合物组成的程度超过50％的重量。所述混合物特别是血液相容的，并且因此进一步改善了过滤装置、更特别是透析器的性能。
根据本发明的第二方面，所述目的通过一种用于制造根据本发明的第一方面的过滤装置的方法来实现，其特征在于，所述第一和第二密封区均通过熔合和冷却所述壳体和所述端盖的面向密封区的区域形成密封连接来制造，并且所述壳体的分子与所述端盖的分子进行缠结。
在所述方法的一个发展中，密封区均通过焊接、特别是通过平面面焊接、激光束焊接、旋转焊接或超声波焊接，特别是通过热表面焊接来制造。这些方法确保了部件的安全熔合和接合。特别地，所确保的是，可以提供期望的接合区、更特别地是凸缘状接合区。
如果采用热表面焊接或热板焊接方法，则优先考虑执行以下制造过滤装置的方法步骤：
a)提供端盖；
b)提供管段形壳体；
c)在端盖和壳体之间提供热板焊接工具，其中，热板焊接工具至少在预定的至少4个接触区的温度高于特定连接材料的熔点或玻璃瞬变点；
d)将热板焊接工具与端盖和壳体的待焊接触区接触；
e)熔化接触区；
f)取下热板焊接工具；
g)加压熔化的接触区，焊接端盖和壳体；
h)将熔化的接触区冷却到特定材料的熔点或玻璃化转变点以下。
根据本发明的第三方面，提供了一种热板焊接工具，它适用于提供根据本发明第二方面的方法或用于根据本发明第二方面的方法。
因此，这种热板焊接工具有4个接触区，在根据本发明第二方面的方法进行焊接时，端盖和管段形壳体会同时发生局部接触和材料熔化。
在一个优选的实施例中，需要熔化的壳体和热板焊接工具之间的接触区设计成使得壳体或端盖的接触区在(构想的)壳体纵向方向上以不同于0°和90°的角度形成的表面上撞击工具。优先考虑20°至70°之间的角度，更优先考虑30°至60°之间的角度，再进一步优先考虑40°至50°之间的角度。
根据另一个实施例，这些接触区是凹形的。
附图说明
本发明的其它细节和优点将基于附图中所示的示例性实施例来更具体地阐明。在附图中：
图1示出了管段形壳体的示意图；
图2示出了端盖的示意图；
图3示出了过滤装置的示意图，所述过滤装置包括管段形壳体和端盖；
图3a示出了图3在第一密封区的区域中的放大图；
图4示出了在热板焊接工艺的加热阶段期间管段形壳体、端盖和热板焊接工具的布置的示意图；
图5a是热板焊接工具与相关壳体部分的剖面示意图，描述了一个特定的实施例；
图5b是热板焊接工具与相关端盖部分的剖面示意图，描述了一个特定的实施例；
图6a是热板焊接工具的剖面示意图，描述了一个特定的实施例；
具体实施方式
图1示出了过滤装置1的管段形壳体2，所述过滤装置1包括由半透膜4构成的中空纤维束3。在端部处，管段形壳体2包括流动空间密封件8，所述流动空间密封件8在此被示出为朝向重心S凹入。流动空间密封件8由聚氨酯制成；环氧树脂或陶瓷密封材料的类似布置是可能的。如果过滤装置1用于透析，则聚氨酯是优选的。流动空间密封件8的外表面被配置为使得中空纤维膜4是开放的，并且因此形成包括中空纤维膜4的内部的第一流动空间6。第二流动空间7在壳体2中位于中空纤维膜4的外部。图1还示出了壳体2中的缺口9，缺口9被布置成比流动空间密封件8更靠近壳体2的重心S。如果过滤装置1是透析器，则透析液可以经由所述缺口9供应到中空纤维膜4的外表面或从其移除，并且因此可以在由第一流动空间6表示的透析器的血液侧和由第二流动空间7表示的透析液侧之间发生物质交换。在另一个实施例中，还可以将血液引导到第二流动空间7中并且将透析液引导到第一流动空间6中。壳体2还包括壳体突出部2a，其被布置成比流动空间密封件8和缺口9更靠近壳体2的重心S。
图2示出了具有第一开口11和第二开口12的端盖10。在所述开口11和12的外侧设置有螺纹18或用于连接流体管线的装置，在此未示出。
图3示出了端盖10与管段形壳体2的组装。这两个部件被设计成使得存在第一密封区13和第二密封区14。然后，流体可以经由第一开口11进入第一流动空间6或从开口11排出；第一密封区13防止流体不希望地转移到第二流动空间7中。然后，流体可以经由第二开口12进入第二流动空间7或从第二开口12排出；第一密封区13和第二密封区14防止第二流体不希望地转移到第一流动空间6中。在管段形壳体2上示出了突出部2a，在该实施例中，所述突出部2a与端盖10一起形成第二密封区14。
图3a示出了第一密封区13的区域的放大图，并且所形成的第一密封区13大于管段形壳体2在壳体端部处的横截面积。所形成的是凸缘15。在该示例性实施例中，其通过热板焊接方法制造，接合配对件以一定的压力接合，使得第一密封区13扩大。
图4示意性地示出了在通过接合端盖10和管段形壳体2形成过滤装置1时的接合过程，两个接合配对件由聚丙烯构成。其它材料也是可能的、特别是聚碳酸酯。图4示出了端盖10、管段形壳体2和热板焊接工具16的横截面。所述工具提供了与端盖10和壳体2的区进行接触的接触区，这些区必须被接触以接合工件，以便形成第一密封区13和第二密封区14。在所示的实施例中，还示出了工具加热元件17，其确保将接合配对件的接触区加热到材料的熔点或玻璃化转变点以上。在加热过程之后，接合配对件可以进一步移动分离，从而可以移除热板焊接工具16。然后，接合配对件被接合，使得形成第一密封区13和第二密封区14。在该实施例中，端盖10的分子与管段形壳体段2的分子紧密地缠结。这产生了第一密封区13和第二密封区14，它们具有特别高的密封性。
替代地，第一密封区13和第二密封区14也可以通过旋转焊接或通过激光束焊接来提供。当第一密封区13和第二密封区14旋转对称地布置时，旋转焊接是可能的并且是优选的。超声波焊接同样是可能的，并且在这种情况下，优选相应地在管段形壳体2和/或端盖10上设置至少一个能量引导器。
图5a描述了通过连接端盖10和管段形壳体2来形成过滤装置1的连接过程的另一个优选实施例，并以放大剖面图描述了管段形壳体和热板焊接工具16的一部分。在本实施例中，壳体2待熔化的部分和热板焊接工具16之间的接触区设计成使得壳体2的接触区相对于壳体纵向方向以不同于0°和90°的角度与工具接触。优先考虑20°至70°之间的角度，更优先考虑30°至60°之间的角度，再进一步优先考虑40°至50°之间的角度。在示例性实施例中，标出的角度为45°。这样做的好处是可以精确控制接合点，从而产生特别牢固的接合点，不容易被再次顶出。此外，这种设计的焊缝特别小，从而减少了分离过程中流体流动路径可能受到的限制。就透析器而言，这特别适用于透析液侧。
图5b描述了通过连接端盖10和管段形壳体2来形成过滤装置1的连接过程的另一个优选实施例，并以放大剖面图描述了端盖和热板焊接工具16的一部分。在本实施例中，端盖10的需要熔化的部分与热板焊接工具16之间的接触区设计成使得端盖10的接触区与工具16的接触区相对于过滤装置(构想)的纵向方向以不同于0°和90°的角度接触。优先考虑20°至70°之间的角度，更优先考虑30°至60°之间的角度，再进一步优先考虑40°至50°之间的角度。在示例性实施例中，标出的角度为45°。这样做的好处是可以精确控制接合点，从而产生特别牢固的接合点，不容易被再次顶出。此外，这种设计的焊缝特别小，从而减少了分离过程中流体流动路径可能受到的限制。就透析器而言，这特别适用于血液侧。焊珠的设计应尽可能在血液空间中形成尽可能小的死体积，甚至可以完全避免死体积。血液侧的死体积会导致血液过度凝固，从而增加透析器的堵塞。
图6a描述了另一个实施例，是对图5a实施例的进一步改进。在该实施例中，壳体2待熔化的部分与热板焊接工具16之间的接触区被设计成使得壳体2与工具的接触区位于在壳体纵向方向上以不同于0°和90°的角度形成的表面上，该表面具有凹形弧度。凹形弧度是指弧度凸出热板焊接工具。曲率半径必须与壳体尺寸相适应。对于透析器大小的过滤装置，曲率半径最好在1毫米到10毫米之间、特别是2毫米到8毫米之间、特别是3毫米到6毫米之间。在本实施例中，半径为4.5毫米。凹形弧度有助于精确安装接合件，即使在接合件公差增大的情况下也是如此，从而进一步提高了产品的可靠性和焊接质量。当壳体材料是聚烯烃、特别是聚丙烯基材料时，公差会更大。图6b适用于端盖2的连接。
附图标记列表
1 过滤装置
2 管段形壳体
2a 壳体突出部
3 中空纤维束
4 半透膜
5 壳体内部
6 第一流动空间
7 第二流动空间
8 流动空间密封件
9 缺口
10 端盖
11 第一开口
12 第二开口
13 第一密封区
14 第二密封区
15 凸缘
16 热板焊接工具
17 工具加热元件
18 螺纹
S 重心
K 接触区

Claims (14)

1.一种用于物质交换的过滤装置、更特别是用于血液透析的过滤装置，包括：
·具有重心和两个壳体端部的管段形壳体，在所述壳体中布置有由半透膜构成的中空纤维束，所述中空纤维束的纤维腔形成第一流动空间，包围所述中空纤维束的壳体内部空间形成第二流动空间，
·其中，所述第一和第二流动空间在壳体端部处通过至少一个流动空间密封件彼此分离，
·其中，所述壳体在至少一个端部处设置有至少一个缺口，所述至少一个缺口被布置成比所述流动空间密封件更靠近所述壳体的重心；
·所述过滤装置还包括具有第一和第二开口的至少一个端盖，
·其中，所述壳体和所述至少一个端盖形成第一密封区，所述第一密封区以密封方式连接所述壳体和所述端盖，所述第一密封区比所述至少一个缺口更远离所述壳体的重心，以及
·其中，在所述第一密封区与所述端盖的第一开口之间形成第一流体空间，所述第一开口经由所述第一流体空间流体连接到所述第一流动空间，
·其中，所述壳体和所述至少一个端盖形成第二密封区，所述第二密封区以密封的方式连接所述壳体和所述端盖，所述第二密封区被布置成比所述流动空间密封件和至少一个缺口更靠近所述壳体的重心，以及
·其中，在所述第一密封区和第二密封区与所述端盖的第二开口之间形成第二流体空间，经由所述第二流体空间，所述端盖的第二开口通过至少一个缺口流体连接到所述第二流动空间，
·其中，所述第一密封区和第二密封区不是由密封剂形成的。
2.根据权利要求1所述的过滤装置，其特征在于，在所述第一密封区和所述第二密封区中，所述壳体的分子与所述端盖的分子缠结。
3.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述第一密封区比所述至少一个缺口和所述流动空间密封件更远离所述壳体的重心。
4.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述管段形壳体和所述端盖由同一组材料形成。
5.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述壳体和所述端盖的材料包括聚丙烯或聚丙烯的共聚物或聚碳酸酯、更特别是包括聚丙烯或聚丙烯的共聚物。
6.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述第一密封区等于或大于、特别是大于所述管段形壳体在壳体端部处的横截面积。
7.根据前述权利要求中任一项所述的过滤装置，其特征在于，在所述管段形壳体的相反端部处设有两个端盖，所述壳体在两个端部处均设置有缺口和流动空间密封件，所述缺口均被布置成比所述流动空间密封件更靠近壳体的重心。
8.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述壳体在至少一个端部处具有多个缺口。
9.根据权利要求7所述的过滤装置，其特征在于，所述过滤装置是透析器，所述端盖的第一开口允许血液流入和血液流出，所述端盖的第二开口允许透析液流入和透析液流出。
10.根据权利要求9所述的过滤装置，其特征在于，所述管段形壳体不具有透析液入口或出口。
11.根据前述权利要求中任一项所述的过滤装置，其特征在于，所述半透膜的材料包括聚砜、聚乙烯吡咯烷酮、聚甲基丙烯酸甲酯、聚酰胺、聚酯、纤维素或聚丙烯腈。
12.一种用于制造根据前述权利要求中任一项所述的过滤装置的方法，其特征在于，所述第一密封区和所述第二密封区均通过熔合和冷却所述壳体和所述端盖的面向所述密封区的区域形成密封连接来制造，所述壳体的分子与所述端盖的分子进行缠结。
13.根据权利要求12所述的方法，其特征在于，所述第一和第二密封区均通过焊接、特别是通过平面焊接、激光束焊接、旋转焊接或超声波焊接、更特别是通过热表面焊接来制造。
14.一种用于实施根据权利要求12所述的方法的热板焊接工具。
CN202280027321.3A 2021-04-09 2022-04-06 透析器 Pending CN117545543A (zh)

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