method of joining first and second fluid flow circuits to form a fluid flow circuit assembly, and fl

专利摘要:
FLUID AND APPLIANCE FLOW CONDUITS AND METHODS FOR THE PRODUCTION AND UNION OF FLUID CONDUITS. The present invention relates to the fluid flow ducts (14a, 14b) and apparatus (40) and methods for joining the ducts (14a, 14b), preferably in a sterile manner, are disclosed. Each conduit (14a, 14b) has an open polymeric end which is sealed by a sealing member (26a, 26b) which can include a heating element (28). The polymeric terminal material is melted, the sealing members (26a, 26b) are moved to expose the molten open ends of the conduits (14a, 14b), and the ends are brought together to form a fused or welded connection (12) between the conduits (14a, 14b).
公开号:BR112013027306B1
申请号:R112013027306-2
申请日:2012-12-12
公开日:2021-02-09
发明作者:Kyungyoon Min；Christopher Wegener；Mark J. Brierton；Benjamin E. Kusters；James Madsen；William H. Cork
申请人:Fenwal, Inc.；
IPC主号:

专利说明:

Cross Reference to Related Orders
[0001] This application claims priority and benefit from United States Patent Application Serial No. 61 / 578,690, filed on December 21, 2011, United States Patent Application Serial No. 61 / 585,467, filed on 11 January 2012 and United States Patent Application Serial No. 61 / 617,745, filed on March 30, 2012, each of which is thus incorporated by reference in its entirety. Technical Field
[0002] The present disclosure refers, in general, to fluid flow systems and apparatus and methods for assembling such systems. More particularly, but not exclusively, the present subject matter refers to sterile fluid flow systems, assemblies and subassemblies, and methods and apparatus for producing connections, preferably sterile connections, in such systems. Prior Art
[0003] Fluid flow systems or assemblies that are pre-sterilized and / or pre-assembled are used in a wide variety of medical applications. Medical applications may include, for example, administering medical fluids to a patient for therapeutic and / or diagnostic purposes, blood and / or blood components, or other cell collection or processing, dialysis and other medical procedures. Non-medical applications for such systems or assemblies can include, for example, pharmaceutical production and cell processing. In the medical field in particular, such flow systems commonly employ one or more pre-filled containers, or other sources of medical fluid or agent, and an associated fluid flow circuit or system (sometimes called a tube set) containing the necessary flow tube, valves, flow controllers, process chambers, and the like, to perform the particular procedure, either alone or in cooperation with a reusable controller, or other device. It is not unusual, for example, for a medical fluid flow system to include or be used in combination with a container of a suitable drug, saline, anticoagulant, dextrose, sterile water, cell preservative, or the like, to name just a few examples.
[0004] Such a fluid flow system can, however, impose production or assembly challenges for different reasons. One reason may be that containers pre-filled with medical liquid, powder or other agent, which is administered to the patient or otherwise employed in the medical fluid flow system, require different sterilization techniques than other portions of the system fluid flow. For example, empty plastic tubes, containers, flow control devices and / or processing devices or chambers, which do not contain any substantial amount of liquid or other agent, can be sterilized with electron or gamma beam radiation (e- beam), or by exposure to a sterilization gas, for example ethylene oxide. However, the sterilization gas would be inefficient to sterilize an agent, such as a liquid, powder or drug, contained in a sealed container, and exposure of the agent to ionization radiation may degrade or otherwise have a harmful effect on the agent . Also, there may be situations where different portions of a sterile fluid flow system, even though suitable for the same sterilization process, are separately produced and sterilized for other reasons and then subsequently assembled in a sterile manner.
[0005] In addition, sterile connections often need to be produced on site, by the end user, for example, at the location where fluid flow systems are being used to treat patients or collect or process blood, or blood components , or biological materials, or in other therapeutic or diagnostic procedures. For example, it may be desired to attach a fluid source, filters, tube or the like, to another device, without compromising the sterility of any pre-sterilized components or parts of the assembly.
[0006] As a result of these various needs, a number of approaches have been used in the assembly of sterile fluid flow systems. For example, a technique for producing such systems employs the use of a sterile reception system, such as a device disclosed in United States Patent No. 4,157,723. As illustrated therein, the sterile host system comprises a pair of conjugated members, each having a facing membrane. One of the conjugated members is attached to a pre-sterilized container of liquid, drug, or other agent, and the other conjugated member is attached to a pre-sterilized fluid flow system, which may include or more empty containers. After the two members are joined, the improvement system is exposed to radiant energy, causing the membranes to melt and form a sterile fluid path through the conjugated members. The fluid can then be transferred from the initial container into an empty container in the fluid flow system, and the flow path sealed and dissociated. The initial container and conjugated members are then discarded. While this operates satisfactorily, it determines multiple steps of producing solution transfer from one container to another in a sterile manner and the quality control procedures associated with that step. It also requires the provision of a portion of the product with increased product and cost of waste.
[0007] Another technique for assembling medical flow sets that have different pre-sterilized portions, such as the type requiring different sterilization processes, employs an electron beam. This technique, as described in United States Patent No. 5,009,645, requires a procedure for producing an electron beam or the like to sterilize isolated portions of subsets after they have been joined together. After the isolated regions are joined and sterilized, frank clamps or closures that isolate the regions can then be opened to allow direct sterile communication between the subsets. Such a procedure and the use of e-beam or similar radiation, of course, requires a substantial investment in production equipment, as well as additional procedures and safety during production.
[0008] To avoid the use of more complicated production processes, it has been revealed to use sterilization filters in the intake flow line that couples a pre-sterilized liquid container or similar, to a separately sterilized fluid flow tube system . Such an arrangement is illustrated in United States Patent No. 4,978,446. In the approach in the '446 patent, however, doctors are required to manually attach the fluid flow tube system to the fluid container, such as by drilling the fluid container with a drilling member associated with the fluid flow system. . In addition to the administrative requirements for individually ordering, storing and prescribing available or combined flow solutions and systems, there is the added possibility of errors, such as by connecting an incorrect liquid container or other agent, or an improper flow system to be used in association with the procedure.
[0009] Also, there is a device known commonly referred to as a sterile tube welder that is marketed by Terumo Medical Corporation as the "SCD Device". This device uses a heated insert to split and melt the ends of the tube, which are joined together after the insert is removed. Aspects of this device are disclosed in several patents, including United States Patent Nos. 4,753,697, 5,158,630 and 5,156,701. Although widely used, particularly as an "on-site" tool to allow users to assemble a system in such a configuration as they wish, this device requires the use of costly inserts which are replaced after each division.
[00010] Sterile connection systems using a melting process are found in WO 2008/131442 A2 and WO 82/02528, and a sterile connection system using a movable inner wall and limited sterilization is found in United States Patent 4,030 .494.
[00011] Consequently, there remains a significant need for advances in this field. summary
[00012] This subject matter, as cited in part in the attached independent claims, is summarized below for proposal of introduction only. This summary is not intended to be a total or complete summary, or listing of all aspects, or of the broader aspects of the present subject matter, and is only presented to familiarize the reader with a subject matter of this, which is placed more fully in the following description and in the appended claims. The subject matter of this description has numerous separate and independent aspects including fluid flow ducts, circuits and assemblies, individual and assembled, methods and apparatus for producing such ducts and assembling them, and unique components used in such ducts and their devices. unity. Consequently, the expressions used here are only to guide the reader, and do not mean that the description under a particular heating is limited to, or only belongs to, the specific subject matter of the title.
[00013] In one aspect, a method is provided for joining first and second fluid flow circuits, or subsets to form a fluid flow circuit assembly. Each fluid flow circuit or subset includes a fluid flow conduit with a lumen and an open end that ends in a heat-melted material, such as a polymeric material, which softens or melts when heated, and hardens after cooling, and a sealing member fixed to the flow duct and preferably sealing the open end thereof. At least one of the sealing members includes at least one heating element. The method includes: (a) melting material from the open ends by heating at least one heating element; (b) relatively moving the sealing members and the respective open ends to which they are sealed to expose the open ends; and (c) bringing the exposed open ends together while melted to form a junction between the fluid flow circuits that allow fluid flow between them. Although the sealing member is typically referred to as closing or sealing the fluid flow duct, for joints where sterility or sterile connection is not required, the sealing member does not need to seal the open end of the duct from ambient conditions.
[00014] In another aspect, a method is provided for producing a fluid flow conduit that can be used with other aspects of the present object matter. The method includes providing a hollow tube having a meltable lumen and distal end, and connecting the distal end of the tube to a sealing panel that includes a heating element or member, the sealing panel of which seals the tube hermetically. The distal end material can be a polymer or other suitable material as explained below. The panel may have one or more layers, as in a laminated web or film, for example.
[00015] In yet a further embodiment, a single or subset fluid flow circuit is provided. The fluid flow circuit includes a fluid conduit having a lumen and at least one open end that ends in a heat-melting end material (for example, a polymer material) and a sealing member that seals the end flue open. The sealing member includes at least one heating element configured to melt the terminal material after energizing, and the sealing member and open end of the conduit are relatively mobile to a non-sealing position after heating to expose the melted terminal material.
[00016] In another aspect, a fluid flow circuit assembly is provided comprising first and second separate fluid flow circuits or subsets, each of which includes: (i) a fluid conduit including a lumen and at least one open end that ends in a terminal material that can be melted by heat (such as a polymeric material); (ii) a sealing member that seals the open end of the conduit; (iii) the sealing member including at least one heating element configured to melt the terminal material after energizing; (iv) the sealing member being movable to a non-sealing position after heating to expose the melted terminal material; and (v) a housing that carries the sealing member. The housings of the first and second flow circuits, or subassemblies, are configured for irreversible connection with each other with the sealing members of each circuit being co-operatively in contact with each other with the terminal material of each conduit being in compression, as that after heating such sealing members to melt the terminal material of each conduit and movement of the sealing members to expose the melted terminal material, the molten ends engage together to form a sealed joint between them.
[00017] In a still further aspect, the connection apparatus is provided for joining two fluid flow circuits or subsets of the type comprising: a fluid conduit including a lumen and at least one open end that terminate in a terminal material that it can be melted by heat (for example, a polymeric material); a sealing member that seals the open end of the conduit; the sealing member including at least one heating element configured to melt the terminal material after energizing; and the sealing member and open end of the conduit being relatively movable to a non-sealing position after heating to expose the melted terminal material. The connection apparatus includes: (a) opposed duct retainers, each of which is configured to retain a portion of one of the fluid flow circuits or subsets, with the open ends generally in axial alignment. The duct retainers are relatively mobile to move the sealing members towards each other to retain them in contact with each other. The connecting apparatus also includes a power source for heating at least one of the heating members that sufficiently melts the end material of the respective flow circuits, and a sealing member retainer configured to retain the sealing members. The sealing member retainer and the duct retainers are respectively laterally movable to move the sealing members between the open ends when the terminal material is melted.
[00018] In a still further aspect, a method of joining the first and second fluid flow ducts is provided. Each conduit includes a lumen and an open end that terminate in a heat-melted material (for example, polymeric material) and a sealing member attached to the flow duct, and sealing the open end of the duct, and each of the members The sealing element includes at least one heating element. The method includes: (a) placing the sealing members in contact face to face; (b) melting the material from the open ends by heating the at least one heating element of each sealing member; and (c) movement of the sealing members between the respective open ends of the ducts while pressing the open ends of the ducts towards each other to bring the exposed open ends together while melted to form a junction between the flow flow ducts that allow flow of fluid between them. DESCRIPTION OF THE DRAWINGS
[00019] These and other aspects are revealed in the following detailed description and accompanying drawings, of which:
[00020] Figure 1 is a plan view of an exemplary fluid flow assembly formed for joining flow ducts of two fluid flow circuits or subsets that employ certain aspects of matter described in this description.
[00021] Figure 2 is a side view of the connection junction or union formed according to the present object matter between two fluid conduits.
[00022] Figure 3 is a side view of a connection junction or union duct, as shown in Figure 2, and in which at least one and preferably both fluid ducts include internal frangible closures to control the flow. .
[00023] Figures 4 - 9 are seen in partial perspective of two fluid conduits (which may be part of larger fluid circuits or subsets), which, according to the present disclosure are being connected, preferably in a sterile manner.
[00024] Figure 10 is a side perspective view of an exemplary device that can be used in conjunction with two fluid flow ducts according to the present subject matter.
[00025] Figure 11 is a top perspective view of the apparatus of Figure 10.
[00026] Figures 12 - 15 are partial top views of the apparatus of Figure 10, illustrating sequential positions of the apparatus when connecting two fluid conduits.
[00027] Figure 16 is a perspective view of an end portion of a fluid conduit (which may be part of a larger fluid circuit or subset) sealed at the end by a sealing member in the form of a panel (which may be a weft or film of one or more layers or coatings).
[00028] Figure 17 is a perspective view of a multilayer embodiment of a sealing member panel having three layers.
[00029] Figure 18 is a side view of an alternative connection set that connects two fluid conduits (which can be part of larger circuits or subsets) according to another aspect of the present object matter.
[00030] Figure 19 is a top view of the connection set of Figure 18.
[00031] Figure 20 is a cross-sectional view taken along lines 20-20 of Figure 19 before the conduits are connected in relation to fluid flow.
[00032] Figure 21 is an enlarged view of the connection detail in Figure 20.
[00033] Figure 22 is a top view of the connection assembly of Figure 18 after the fluid flow circuits are connected in relation to flow.
[00034] Figure 23 is a cross-sectional view taken along lines 23-23 of Figure 22.
[00035] Figure 24 is an enlarged view of the connection detail in Figure 23.
[00036] Figure 25 is an exploded side view of the connection assembly of Figure 18, also showing an induction power source mounting fixture for the assembly.
[00037] Figure 26 is a cross-sectional view illustrating another embodiment of a connection set and method for joining two fluid flow ducts employing certain aspects of the subject matter of this description, and showing the ducts before connection.
[00038] Figure 27 is a sectional view of the whole of Figure 26 in the fixed configuration and before the union between the conduits is formed. Detailed Description
[00039] Figure 1 illustrates an example of a fluid circuit assembly 10, including a connection or union 12 that joins two fluid flow ducts 14a, b, which are illustrated as part of first and second fluid circuits or subsets 16 and 18, respectively, to form the fluid circuit assembly 10. Each fluid flow circuit or subset 16 and 18 can include additional tube, containers, valves, separation chambers, and other selected fluid processing or storage devices as desired for the particular application. As illustrated, each circuit or subset, the fluid conduits 14a, b of each may include one or more fluid flow paths from tube 20a, b and fluid containers 22a, b, but the exact components of each circuit or subset may vary as usage requires, and fluid containers are optional in one or both fluid circuits.
[00040] The present subject matter has potential application in a wide variety of environments, industries and applications. In these broader aspects, it is not limited to the production of sterile connections. However, it will be appreciated that it has particular application and benefit in producing sterile connections between pre-sterilized conduits, flow circuits or subsets of a sterile fluid flow set or system, such as an available sterile medical fluid flow system. Such sterile fluid flow systems can be found in any of a variety of medical and non-medical applications, and systems such as (1) administration or removal to or from a patient for any diagnostic or therapeutic proposal, (2) collection, storage or processing of blood or blood components, or other cells or cellular materials, (3) blood separation and / or collection systems for use with hardware, as provided by Fenwal Inc., Caridian, Inc and / or Haemonetics Inc. , (4) pharmaceutical production, (5) cell culture and / or (6) other sterile fluid flow system applications where fluid collection, storage or processing is desired, whether or not the system is directly attached to a human or animal.
[00041] In a non-exhaustive example, such a fluid circuit assembly 10 can be configured for use in collecting or processing blood, or blood components, and can comprise a pre-assembled, sterile and available medical fluid flow system , which may be associated with the ALYX Centrifugal Blood Processing System, sold by Fenwal, Inc. of Lake Zurich, Illinois, and illustrated in more detail, for example, in United States Patent No. 6,322,488, which is thus , incorporated by reference. The ALYX system is only intended for the purpose of illustrating a type of medical fluid flow system, and the present subject matter can be used in any of a wide variety of sterile fluid flow systems in general and flow systems. pre-sterilized fluids available in particular.
[00042] As noted above, the present subject matter has particular application to sterile available medical fluid flow systems (for example, set 10), which are assembled by joining fluid circuits or circuit subsets (for example, circuit circuits) fluid flow 16 and 18) which are pre-sterilized and subsequently joined together in a sterile manner to provide a sterile fluid circuit assembly of a desired configuration. This has application, for example, where the first or second fluid flow circuits are separately pre-sterilized because it includes a therapeutic, diagnostic, or other agent that is not suitable to withstand the same sterilization process as the other circuit fluid flow. For example, a fluid flow circuit that is "wet" (includes a sealed container of drug or other liquid), may require steam or heat sterilization, so a fluid flow circuit that is "dry" (includes only empty tube, containers, and the like) can be efficiently sterilized by gas or radiation. Other factors may also indicate the type of sterilization, such as the materials or configuration, contents and or last use of the fluid flow circuit. In addition, the present subject matter has application where the first or second fluid flow circuits are separately produced and pre-sterilized for reasons other than sterilization, such as convenience, production efficiency, marketing, user flexibility in assembly of the desired fluid flow circuit assembly in place, and / or other reasons.
[00043] Referring again to Figure 1, it is within the scope of this description that the first and second circuits 16 and 18 may include additional parts or parts of the total system assembled in any desired mode. Also, circuits 16 and 18 can be part of a large system or systems, the other portions of which are assembled in a different way than described here, and which are not necessarily pre-assembled in their entirety. Nor does this description preclude the possibility that other components are subsequently attached to or associated with circuits 16 and 18, or are added to the total system, in a different way than described or claimed herein.
[00044] Figure 2 is an enlarged view of the connection or union 12 formed between the fluid flow ducts 14a, b of the respective circuit or subassembly 16, 18. The connection, as described in more detail below, is specifically a union in that the open ends of the conduits weld or fuse together while melted, to provide a permanent sealed joint between the conduits (and any associated fluid circuits or subassemblies) that is open sufficiently to allow fluid flow between them. As illustrated and preferred, the connection 12 is sufficiently strong so as not to require any other connection or reinforcement structure, and is preferably only a weld or fusion connection between the open conduit ends.
[00045] As described in more detail below, to achieve this welded or molten connection, each conduit 14a, b ends at an open end that is produced from a material, such as a thermoplastic polymeric material, that softens sufficiently when heated to allow for formation of a solder or fusion bond between the conduits, and hardens when cooled. In a preferred configuration, the ducts end in a thermoplastic polymer material, preferably flexible and resilient, such as polyvinyl chloride (PVC), polypropylene (PP), or other polymeric material, which becomes sufficiently soft and amorphous when heated to allow a melting or solder bond to form between the material at the ends of the ducts when they are brought together, and hardens when cooled. For the purpose of this description, this softening is referred to as "melting", and the ends of the conduit can be referred to as melted or fused - - although it is understood that for thermoplastic polymeric material, this "melting" is more of a transition nature. a crystalline phase to an amorphous phase than an abrupt solid-liquid transformation. References to polymeric material here will be understood to refer to thermoplastic polymeric material, which exhibits the above properties.
[00046] Returning to Figure 3, although the conduits 14a, b leading to the connection can be opened for fluid flow immediately after the connection 12 is made, as shown in Figure 3, it is also contemplated that the one or both conduits may include an internal frangible closure 24a, b. Frangible closures that can be opened by external manipulation, without sterility, such as by manual or automatic bending or bending of the conduit tube, are well known in the medical industry. Examples of such frangible closures can be found in, inter alia, United States Patent Nos. 4,340,049; 4,181,140 and 5,330,464, which are hereby incorporated by reference. With frangible closures 24a, b in one or both ducts 14a, b, the user can confirm the integrity of connection 12, if desired, (for example, by performing a pull test) before allowing the fluid to flow through the opening of frangible closures.
[00047] Figures 4 - 9 diagrammatically illustrate the formation of the connection 12 between the conduits 14a, b of the respective fluid flow circuits or subassemblies 16 and 18. As noted previously, the fluid flow circuits or subassemblies can have any configuration or components, with or without fluid containers. Figures 4 - 9 show only the end of conduits 14a, b for simplicity and ease of illustration of the connection or junction formation 12. The illustrated conduit portions can, for example, be terminal pipe segments specifically selected for connection as herein described, or continuation of tube used throughout the respective fluid circuit or subset. As shown in Figures 4 - 9, each conduit has an internal lumen or hole 15a, b that defines a fluid flow path. The open end of the lumen or hole of each respective conduit 14a, b has a sealing member 26a or 26b attached to it, respectively. The sealing member preferably closes the end of the conduit and, if the conduit is pre-sterilized, it seals the conduit to preserve its sterility. Sealing member
[00048] Sealing members 26a, b can be of any suitable configuration, shape or size, and fixed to the open end of conduits 14a, b by adhesive, solvent or hot solder, and can be of the same or different configuration or materials. As described in more detail below, the sealing member can include at least one heating element which, during the connection procedure, is heated to an elevated temperature which causes the material at the open ends of the ducts to melt. For producing sterile connections between pre-sterilized fluid flow circuits or subsets 16 and 18, the elevated temperature is preferably high enough to cause sterilization of the sealing members, or at least those portions of the sealing members that are exposed to the sterile lumen in the conduits.
[00049] More specifically, each sealing member 26a, b is not limited to a single element or device, but can be a set of multiple parts and pieces including, if desired, the heating member or element (which likewise , can be more than one part or piece). As shown in Figure 4, the illustrated sealing members are each configured as a relatively thin panel, such as a weft or thin film, which can be a single layer or multiple layers, such as two, three or more layers or coatings or laminations. The illustrated sealing member is a panel having two layers 28 and 30.
[00050] As shown, layer 28 can be an electrically conductive material, such as a conductive polymer, or conductive metal, which functions as a heating member. If metallic, layer 28 may be a film or sheet produced from a single material, such as copper, aluminum, stainless steel, brass, bronze, gold, or silver, or an alloy thereof, or include multiple thicknesses or layers of different metallic materials , if desired. Also, the metallic layer 28 can have such surface treatment, coatings, addition layers for such another proposal, as may be desired, such as protection against oxidation. For the purpose of this description, "film" and "sheet" are used per account. Although Figures 4 - 9 show each sealing member with two layers, one of which is a conductive layer, it is intended that the sealing members are not required to be of identical construction, although it may be preferred from a production point of view. Also, it is not required that each sealing member includes a heating element, although this may also be preferred.
[00051] The electrically conductive material acts as a heating member, and when energized, such as by electrical induction, application of direct electrical voltage, radiofrequency energy, or micro-wave, heats up to an elevated temperature. At present, inductive heating of the conductive material by applying a magnetic field is preferred, in part because physical contact between the heating element and the energy source is not required, so resistive heating, via direct application of voltage to the conductive material, be an alternative. Microwave heating also has the advantage that it does not require physical contact between the heating element and the power source. If microwave heating is used, a coating of suitable material can be used on the film or foil to better distribute the microwave energy.
[00052] Conductive layer 28, if a metallic conductor, preferably has a thickness not substantially greater, and preferably less than or equal to its "skin depth" for the respective electrical frequency of the current induction voltage used. However, thicknesses greater or less than the depth of the skin can be used if desired for other reasons, such as ease of manufacture or handling, or for use with other energy sources. For example, if the depth of the skin of a particular metal at the frequency of a given electrical induction generator is so small that a metal film of such thickness is too fragile for efficient handling in a production setting, the layer of such material it can be thicker than the depth of the skin. Alternatively, a different metallic material and / or a different energy source frequency can be selected to optimize the use of the material, connection efficiency and / or product cost.
[00053] For a different proposal only, the side or surface of the sealing element 26a, b that faces the respective end duct segment 14a, b to which it is attached is referred to as proximal, and the side or surface that faces away from of the conduit segment is referred to as distal. As currently contemplated, the proximal surface of the illustrated multilayer panel sealing member 26a, b, or a portion of the proximal surface, is produced from or includes a layer or coating 30 of a material that is compatible with and suitable for attachment to the respective conduits in order to seal the open end of the conduit. For example, the sealing member panel 26a, b can include a PVC layer or liner that can be directly bonded to a PVC end material of the conduit. If the end of the conduit is produced from another material, such as polypropylene (PP), a proximal coating or layer of a different material (for example, PP) may be required. It should be noted that the two layer panels of Figures 4 - 8 are exemplary only, and may be only a single layer, such as a metallic foil, or they may be additional layers, such as one or more intermediate layers between the proximal layer or coating that connect the conduit and the conductive layer. There may also be additional layers or coatings proximal or distal to the conductive layer as well and / or there may be more than one conductive layer. For example, if it is desired to have a proximal layer of PVC or PP for connection to conduit 14a, b, and the material selected for the conductive layer does not bond well to PVC or PP, an adhesive layer can be provided between the distal conductive layer and the proximal PVC or PP layer. The layers of adhesive or other suitable material can make up one or more other layers of the sealing member, as desired. Most preferably, these materials are biocompatible for use in medical devices, and are non-toxic, and do not cause toxic emissions upon heating.
[00054] Another sealing member alternative includes a layer of aluminum, copper or stainless steel sheet having a thickness of 0.0127 to 0.127 mm (0.0005 to 0.005 inches), and a layer of PVC or another thermoplastic layer. The PVC layer can be formed by applying a PVC emulsion to the proximal surface of the sheet. The total thickness of each laminate can be 0.0508 mm to 0.02032 mm (0.002 to 0.008 inch), and typically less than 0.254 mm (0.01 inch).
[00055] As noted earlier, the sealing members are preferably relatively thin. As a panel, which can be one or more layers, the thickness of the sealing members can be selected for the appropriate application. For example, a panel thickness can be less than or equal to 1.27 mm (0.02 inch), or for producing a sterile connection, as described below, the sealing member can preferably be less than 0.254 mm (0.01 inch) thick and can, for example, be between 0.0508 mm (0.002 inch) and 0.1778 mm (0.007 inch). The panel can also be thicker or thinner as desired. Fixation of the sealing member / flue
[00056] As can be seen in Figures 4 - 8, the sealing members 26a, b illustrated are each panel of elongated rectangular shape and, preferably, but not necessarily connected to the end of the respective ducts 14a, b in a location, such as a remote location, closer to one end of the panel. This positioning makes the remaining portion of the panel available for easy fixing, gripping or, otherwise, engagement, for the proposal described later.
[00057] As described above, the material defining the open end of each conduit 14a, b is a suitable heat-melted material, for example, thermoplastic polymer, such as PP or PVC. In order to avoid excessive melting of the end of the conduit 4, when producing a sterile connection as described below, the material of the conduit can preferably be selected to have a melting temperature that approaches or exceeds the sterilization temperature. PP, for example, typically has a higher melting temperature than PVC, and may be preferred in certain applications. This will be explained in more detail below.
[00058] As shown in Figure 4, each sealing member 26a, b is preferably hermetically sealed to the open end of the conduit 14a, b to seal it against contamination during loading and handling, and preserves the sterility of the conduit (and any fluid circuit associated) if it has been pre-sterilized. Each sealing member 26a, b is essentially as described above, and can be of any suitable construction. In a preferred embodiment, the sealing member is in the form of a panel that includes a layer of conductive foil or film 28 that acts as a heating element and the proximal surface of the laminate has a layer or coating or material 30 compatible with the material at the end of the conduit. For a PP conduit end material, for example, the proximal layer or coating can be PP or other compatible material.
[00059] The sealing member 26a, b can be hermetically sealed to the open end of the respective ducts 14a, b by pressing the proximal side of the panel against the open end of the duct, and heating the sheet by direct, induction heat energy, resistive, microwave, radiofrequency, or ultrasound energy, or other means, until the end of the duct and the proximal layer of laminate sufficiently melted bond or fuse together, sealing the interior of the first fluid flow circuit 14a, b. As previously explained, the sealing member can also be fixed by adhesive or other means suitable for the materials involved and the intended end use. After the sealing member is attached to the conduit, the conduit and associated fluid flow circuit 16 or 18 can, if desired, be sterilized in any manner appropriate to the components of the circuit, such as steam, radiation, gas, or otherwise sterilization. In these broader aspects, the present subject matter is not limited to medical fluid flow assemblies, or the joining of pre-sterilized fluid circuits, or subsets. However, it is in the context of joining pre-sterilized fluid flow circuits or subsets to form sterile fluid flow assemblies (for medical fluid flow and / or other applications) where the present subject matter is expected to be particularly applicable.
[00060] As illustrated, both sealing members are multilayer or laminate panels of essentially the same construction, and the end material of both ducts is preferably of the same material, such as PVC or PP, for example. While this may be preferred, it is not required. As noted earlier, the sealing members 26a, b may be identical or may differ. For example, only a sealing member can include a heating element, such as conductive foil or foil, as described above. Also, different materials can be used on the sealing members. It is also contemplated that the ducts may end in different materials, and the ducts in each subset may comprise different materials in different locations. For example, the open end of a conduit may be of one material, and the remainder formed of other materials, such as PP for the terminal material, and PVC for other portions. Connection Formation
[00061] Figures 4 - 9 illustrate diagrammatically how fluid flow sets 16 and 18 are joined to form a sterile fluid flow set after they have been individually assembled and, if desired, pre-sterilized. Referring to Figure 4, conduits 14a, b can each be temporarily mounted in a respective welding or connection fixture, or retainer (not shown in this Figure) with the distal end of the conduit protruding from the fixture. The welding or connection fittings can be of any particular suitable configuration, or material, but are preferably configured to coaxially align the open ends of the conduits 14a, b, with the distal surfaces of the sealing members 26a, b (panels) in one face-to-face relationship.
[00062] As shown in Figures 4 and 5, one or both of the welding fittings are axially movable to bring the distal surfaces of the sealing members together in direct contact with the face, and, preferably, to axially compress the pipe conduit ends. fluid flow 14a, b joints. The compressive force (exemplified by the arrows opposite in Figure 5) used will depend on the duct materials, duct thickness, and device configuration, but it is contemplated that for ducts using PVC or PP pipe of the size (for example, 3 mm - 6 mm (1/8 -1/4 inch) DE) routinely found in available medical fluid flow systems, an axial force of 4.45N - 6.27N (1-1.5 pounds) may be sufficient.
[00063] While kept in contact, in a face-to-face position, as shown in Figure 6, the sealing members 26a, b are heated, such as by induction heating of the conductive sheet or film 28, as previously described, until the sheet is heated sufficiently to melt the terminal material of the ducts. Induction heating can be performed by any suitable induction heater, and the foil or foil positioned in any orientation suitable for the magnetic field of the induction coil, although a parallel relationship between the induction coil and the foil (a perpendicular relationship between the magnetic field and the sheet) may be more preferred. The energy of the induction heater may depend on other variables, but for a flat coil of 2.8 inches in diameter, and having 20 turns, energy from 50 to 100 watts can be used at 50 kHz and with a maximum current of 4 A That is, but an example, however, and other electrical induction generators can be used as needed for the particular configuration of the sealing member and duct involved. If carried out as part of a sterile connection procedure, the elevated temperature is preferably high enough to sterilize the sealing members (or at least the relevant portion of which is exposed to the interior of the duct) during the limited time that heating occurs. The elevated temperature may preferably be 230 ° C or higher, such as 250 - 275 ° C, and, more preferably, 260 ° C or higher. This heating can preferably take place, for example, for 5 or 6 seconds or less. Shorter warm-up times, such as less than 4 seconds or 2 seconds, and potentially even less than 1 second, may be preferred to reduce operator time.
[00064] After or during heating, and while the duct ends remain in a melted state, as best seen in Figures 7 and 8, the sealing members 26a, b (for example, sealing panels) are simultaneously moved laterally between the flue ends. This can be done by the movement, or of the sealing member, or of the duct retainers, or both. This can be done manually or automatically. In the illustrated example, the ducts are kept stationary, and the sealing members are pulled between them. As the sealing members are pulled between the ends of the conduits, the axial compressive force of the welding fittings or conduit retainers simultaneously and progressively forces the molten open ends of the conduits together in a counter-face-to-face relationship, and the molten ends of the conduits weld or fuse together. This preferably occurs relatively quickly, such as 1 - 2 seconds or less.
[00065] In this illustration, the portion of the film or sheet sealing member panel 28 that moves or slides over the open end of each conduit 14a, b is exposed to the interior of the conduit environment. If the respective subset of fluid is pre-sterilized, this portion of the sealing member is exposed to the interior of the sterile field of the conduit. To prevent contamination, the previous heating of the sealing member preferably raises the temperature high enough not only to cause the distal end of the conduit 14a, b to melt, but also to sterilize the surfaces of the sealing member that are exposed to the interior of the sterile field. fluid circuit as the panel is pulled or dragged through the end of the pipe segment. This can be all surfaces of the sealing member or just those surfaces, such as metallic layer surfaces that are exposed to the inner lumen or hole 15a, b of the conduit 14a, b. In this way, these surfaces do not contaminate the interior of the conduit, and the sterility of the conduit and any associated fluid circuit is maintained as the panel is removed from its original sealed position in order to expose the molten end of the conduit to contact with the opposite conduit. This occurs simultaneously with each sealing member 26a, b of each subset 16 and 18, and the ends of the ducts 14a, b immediately engage and seal together as the sealing members are removed, without contamination from the environment - - from so that the sterility of each fluid circuit is maintained.
[00066] After the sealing members are removed, the ends of the ducts are held together in compression by the retainers, while the connection is allowed to cool and the terminal material to harden. This requires only a short time, such as a matter of seconds for polymeric material. Less than 10 seconds, and even less, such as 7 seconds or less, can allow sufficient cooling of PVC or PP duct end material. As a result, fluid flow assemblies 16 and 18 are joined in a sterile manner with a permanent welded or molten joint or union 12, as seen in isolation in Figure 9. The flow circuit ducts can then be removed from the welding fittings or retainers, and the resulting assembly or product is ready for use without further manipulation of the joint (as required in some prior art insert systems), or for such additional production steps as may be desired. Connection Device
[00067] Figures 10 - 15 illustrate a version of a device or apparatus generally at 40 to effect the method described for producing a connection, preferably in a sterile manner, between fluid flow ducts 14 or similar flow circuit tubes , or subsets of fluid flow. Briefly, apparatus 40 includes two conduit retainers 42a, b, power source 44 (seen in Figure 10) and seal member retainer, or handle 46, the operation of which can be automatically controlled by a controller employing, for example , a programmable microprocessor that is programmed to perform the sequence of operations described below, or any appropriate part of them.
[00068] The tube retainers 42a, b illustrated, are each configured to secure or grasp a conduit 14a, b for movement in direction and distant from each other. As shown, each tube retainer has a base 48 and clamp arm or jaw 50 hingedly mounted to the base and pivoted between an elevated loading position, as shown in Figures 10 and 11 to allow positioning or insertion of conduits 14a, b in position for connection, and a lowered fixation position (Figures 12 - 15) of the conduit is trapped between the base and upper jaw.
[00069] Although the details may vary, in the illustrated embodiment, the base is configured with a jaw surface that includes an elongated notch or groove 52 for receiving a conduit 14a, b. The upper jaw or clamp arm 50 has a similar notch or groove 54. The notches or grooves 52 and 54 are in alignment or registration when the upper jaw is in the lower clamping position, and are sized to annularly grasp the conduit.
[00070] The pipe / duct retainers 42a, b are relatively mobile. As shown, conduit retainer 42b is stationary, and conduit retainer 42a is mounted for linear movement along rail 56, but both can be movable, if desired. The tube retainer 42a can be automatically or manually moved by any suitable device, such as mechanical, electrical, hydraulic or pneumatic, for example, a solenoid, stepper motor, gear drive, piston, or other arrangement.
[00071] In any case, the tube retainers 42a and 42b are preferably relatively mobile between a first apart position or station, where the conduits are loaded into the respective retainers (see Figures 11 and 12), and a second connection position more closely. spaced or station (see Figures 13 - 15) where the connection is made. As seen in Figures 11 - 15, the pipe conduit / retainers 42a and 42b are positioned so that the conduits are kept in axial alignment along the center axis 58, and are relatively linearly movable towards and away from each other. along that axis so that the conduits are kept in axial alignment to reach the eventual fusion connection.
[00072] Figure 11 represents the conduit pair 14a, b with sealing members 26a, b fixed, being moved into position for recess loading or receiving groove 52 in the respective conduit retainers 42a and 42b. As previously described, the illustrated conduits 14a, b can each be part of a larger fluid flow circuit, or flow subset 16 or 18, as shown for the exemplary proposal in Figure 1, which are not shown in Figures 11 - 16 for the proposal for simplicity and description only.
[00073] In the illustrated embodiment described above, each conduit 14a, b is attached to the respective sealing member 26a, b in a remote position. This allows a portion of the sealing member, such as a portion of the panel, to extend sufficiently laterally for grip or retention. In the illustrated device 40, the sealing member retainer or handle 46 is provided for fixing or gripping the sealing members. While such a sealing member retainer 46 can take various configurations, in the illustrated device, the retainer, as illustrated, is mounted laterally from the duct retainers in the connection or sealing station.
[00074] The duct retainers 42a, b and sealing member retainer 46 are relatively mobile and, as shown, the duct retainers are laterally stationary, and the sealing member retainer is movable between a first position laterally spaced from the duct retainers (Figures 10 - 12, 15), and a second position closer to the duct retainers for fixing or gripping the sealing members (Figures 13 - 14). The sealing member retainer can be moved by any suitable means, mechanically, electronically, hydraulically, pneumatically, or manually, such as solenoid, gear arrangement, piston, stepper motor, or other.
[00075] As seen in more detail in Figures 10, and 12 - 15, the sealing member retainer 46 illustrated has a pair of clamps that extend laterally or grab arms or claws 60. The clamps are controlled, for example, by any suitable mechanism (electrical, mechanical, hydraulic or pneumatic) or manually for operation between a spaced apart open position (see, for example, Figure 12) and a closed clamping position or grabbing position (see, for example, Figure 13) for fixing the sealing members. As described above and below, the relative lateral movement between the duct retainers 42a, b and the sealing member retainer 46 moves the sealing members 26a, b between the ducts 14a, b when the ends of the duct are melted.
[00076] For heating the sealing members and melting the ends of the ducts 14a, b, the device 40 also includes the power source 44 (Figure 10). The power source can take the form of any power source, such as an electric induction generator, direct voltage source, microwave, generator, or other. In the illustrated embodiment, the heating element of the sealing member or members is heated by induction heating by eddy eddy currents in the heating element (s) by the magnetic field generated by an induction generator. As illustrated, eddy currents are induced in the heating element by a magnetic field generated by the flow of electricity in coils 62. Coils 62 are preferably positioned to generate magnetic flux lines that intersect the heating element in a sealing member (for example, flow lines perpendicular to a metallic film or layer 28 on the sealing member), to generate a current flow within the heating element that causes it to heat up. As shown, the coils 62 are pushed aside to one side of the sealing station. If the sealing station were located inside the coils themselves, the energy requirement for the induction generator can be considerably less. In the illustrated embodiment, a power source may be a 2.4 kW generator operated at 200 - 300 A at 200 KHz, such as Ameritherm EasyHeat 0224, from Ameritherm Inc. of Scottsville, N.Y.
[00077] The power source may employ any electrical generator suitable for creating eddy current flow within the heating element, but it may be preferred for the frequency of the current flow within coils to be roughly matched to the thickness of the heating element. For example, as mentioned earlier, much of the electrical current induced in a conductor occurs within a limited thickness near the surface of the conductor, referred to as "a depth of the skin". The depth of the skin for a given material varies with the frequency of the induction magnetic field. As an example, for an induction field having a frequency of 200KHZ, the thickness of a skin depth is 14.6 μm (0.00057 inch) for copper, and 18.9 μm (0.00074 inch) for aluminum. Thus, having heating elements that are of relatively large thickness relative to the depth of the skin, may be unnecessary and of reduced efficiency for induction heating, at a given frequency. In the present disclosure, a heating element, such as a metallic layer or film, can be equal to or less than the depth of the skin. However, if such results in a metal layer that is too thin or fragile or otherwise unsuitable for manufacturing or production purposes, the metal layer can be of such thickness as is practical in those circumstances. Connection Device Usage
[00078] Now returning to the method of producing a sterile connection using the device as shown in Figures 10 - 15. Figure 10 illustrates the device before any loading steps are taken. The conduit retainer 42a and 42b are spaced tighten in the loading position and the seal member retainer 46 is spaced from the conduit retainers.
[00079] Figure 11 shows the conduits 14a, b being positioned in the conduit retainers 42a, b, with the sealing members 26a, b in relation to the face. In this illustration, the sealing members 26a, b are in the form of relative thin panels such as wefts or films, preferably a multilayer panel, with a layer of at least one of the sealing members being a conductive metallic layer or sheet which acts as a heating element.
[00080] Figure 12, taken from above, shows the conduits 14a, b held in place in the conduit retainers 42a and 42b, with the clamp jaws 50 lowered, and the retainers still spaced tighten in the loading position.
[00081] Figure 13 shows the tube retainer 42a moved towards the tube retainer 42b, bringing the sealing members 26a, b together with the distal surfaces in contact with the face, and exerting an axial compressive force at the ends of the conduits 14a, b. In this Figure, the sealing member retainer 46 moves closer, with a portion of the sealing members located between the grips 60, which are shown in a clamping position. The dashed lines represent the magnetic flux generated by the coils 62 of the power source 44 to induce current in the heating member in at least one sealing member. Heating continues long enough to melt the open ends of both ducts 14a, b and preferably to sterilize the sealing members, or at least those portions of the sealing members that are exposed to the inside of the ducts when the sealing members are moved between the ends of the duct. Thus, if the conduits are pre-sterilized, the sterile field inside them will not be contaminated by pathogens from the sealing members.
[00082] The time and temperature of such heating will vary, depending on the materials selected, the magnetic flux and whether a sterile procedure is desired. For efficiency, it is contemplated that heating may require a relatively short heating time. In a sterile connection situation, the sealing members are preferably heated to a sterilization temperature such as at least 230 ° C and, preferably, 250 - 275 ° C, and at least 260 ° C for 2 - 5 seconds. It can be noted as this point that for a sterile connection, it is preferred that the material that defines the open connection ends of the have a melting point equal to or higher than the sterilization temperature to better confirm sterility before the conduits are melted to form the joint 12.
[00083] After the polymeric ends of the ducts 14a, b have melted sufficiently, and before cooling, the sealing member retainer 46 is moved laterally, pulling the sealing member panels 26a, b between the ducts 14a, b. This action occurs relatively quickly, such as less than 1 or 2 seconds. The axial pressure exerted by the duct retainers 42a, b simultaneously presses the open ends of the ducts progressively together as the sealing members are pulled between them, preventing ambient contamination inside the ducts. The duct retainers continue to press the duct ends together during cooling, and until the duct ends merge together and harden in a permanent mode, or welded joint 12. The cooling time may vary on the duct's end material and temperature , and preferably is not more than 5 - 10 seconds.
[00084] After cooling, the arms of the clamp 50 of the duct retainers 42a and 42b are opened and the sealed ducts 14a, b can be removed from the retainers, with a permanent connection or union 12 formed between them that allows flow of fluid between conduits without additional user manipulation or processing. Sealing member / Alternative duct
[00085] Figures 16 and 17 illustrate an embodiment of conduit 14a, b and sealing member 26a, b, which is presently contemplated as a possibly preferred configuration for sterile connection applications. As shown here, conduit 14a, b is a hollow tubular structure with an inner lumen or hole 15a, b, and is produced from a polypropylene (PP) material, or other suitable material, which has a melting temperature, preferably at or above the sterilization temperature, which helps to ensure that the sterilization temperatures have been reached and / or exceeded when the duct is melted. The size of the tube may vary as needed for the particular application. The sample shown has an internal diameter of 4.1 mm, and an external diameter of 6 mm.
[00086] The sealing member 26a, b illustrated is a tri-layer panel or web having outer layers of polymer, and a middle layer of electrically conductive metal, or conductive polymer. More specifically, the proximal layer is of a material that is compatible with the material at the open end of the conduit, such as PP, and is preferably melt-bondable to PP - - for example, for connection to an open end of conduit 14a, b in Figure 16. As shown, this layer 64 is made of PP and, although the thickness may vary, it is illustrated with a thickness of 0.05 mm. The distal polymer layer 66 is polyethylene terephthalate, and has a thickness of 0.013 mm. The middle layer 68 is preferably metallic, electrically conductive, and can be produced from any of the identified materials or alloys, and preferably a material exhibiting antimicrobial properties, as discussed in more detail later. The illustrated middle layer is an aluminum foil having a thickness of 0.05 mm. The sealing member 26a, b of Figure 17 is heat bonded to the open end of the conduit 14a, b by direct heat welding of the PP layer to the PP conduit, to hermetically seal the open end of the conduit.
[00087] It is noted that many medical fluid flow systems use PVC pipe. If PP is used as the material at the ends of the fluid flow conduit 14a, b, it may be necessary to provide a connecting transition member or other arrangement between the PP conduit and the PVC pipe due to certain material incompatibilities between PVC and PP. Such a transitional member can take any suitable configuration without departing from the spirit of the present revelation.
[00088] The conduit / sealing member assembly of Figures 16 and 17 is believed to be of particular use in the provision of sterile connections using the method and apparatus described above. Specifically, when the heating element (middle layer 68) of the sealing member is heated to at least 230 ° C, such as 250 - 275 ° C and, preferably, at least 260 ° C for at least 2 seconds and, preferably, at least 3 or 4 seconds, sterile connections can be formed between melted PP duct end material. After cooling, the conduit is immediately ready for fluid flow without the need to manipulate the joint 12, as required for other systems. Alternative Realization
[00089] Figure 18 illustrates an example of a fluid circuit assembly 70, including a connection assembly 72 joining two fluid flow circuits or subsets 74 and 76 to form fluid circuit assembly 70. Each fluid circuit or subset 74 and 76 may include additional pipe, containers, valves, processing chambers, and other selected fluid processing or storage apparatus, not shown, as desired for a particular application or end use. In these broader aspects, this embodiment is not limited to the production of sterile connections. However, it will be appreciated that it has particular application and benefit in producing sterile connections between pre-sterilized components, flow circuits or subsets of a sterile fluid flow assembly or system, such as an available sterile medical fluid flow system.
[00090] More specifically, Figure 18 illustrates a fluid circuit assembly in the form of an available flow system 70 comprising at least two flow circuits or subsets that can be pre-sterilized and, more specifically, at least one first fluid flow circuit 74 and a second fluid flow circuit 76. As noted above, it is within the scope of this description that the first and second circuits 74 and 76 can include additional parts or parts of the total assembled system in any desired mode.
[00091] Returning to Figure 20, which is inverted relative to Figure 18, the portion of the first fluid circuit or subset 74, shown in the drawings, includes tube 78, housing 80, end tube segment 82 and a sealing member 84. The tube and tube segment are poured into the liquid flow through them, and can be formed of any suitable material, such as resilient flexible material, such as PP or PVC, or other thermoplastic material, or another plastic that also preferably lends they are connected to the housing and / or sealing member, such as by melting or melting or adhesive bonding. Tube 78 and tube segment 82 need not be of the same material, but it is generally preferred for reasons evident later that at least the tube segment is flexible and resilient.
[00092] Housing 80 can be of any suitable configuration or shape. As shown for the purpose of illustration only, the housing is produced from rigid material, such as rigid plastic for proposal of availability and pipe connection. The illustrated housing is generally oval with a flat wall 86 and dependent side wall 88 which together define an internal recessed area or volume, which can be temporarily sealed or protected by a removable cover (not shown), such as a sealed dust cover. to the bottom edge of the side wall. For fluid flow through it, the housing has a fluid passage in the form of generally L 90 with an inlet for fixing the tube 78 and a discharge within the recessed area for fixing the end tube segment 82. Together, the tube, housing and pipe segment form a fluid flow conduit of the first circuit 74 which, as explained in more detail below, is to be attached, preferably in a sterile manner, to a fluid flow conduit of the second fluid flow circuit 76.
[00093] Now returning to the sealing member 84, "sealing member" is, as described above, not limited to a single element or layer, but can be a set of multiple parts and parts, including a heating member or element ( which, likewise, can be more than one part or piece).
[00094] For the reference proposal only, the side of the sealing element or panel 84 that faces the end tube segment 82 to which it is attached is referred to as proximal, and the side or surface that faces away from the tube segment is referred to as distal. As presently contemplated, the proximal surface of the panel 84, or a portion of the proximal surface, includes a layer or coating of a material that is compatible with and suitable for connection to the end pipe segment 82 in order to seal the open end of the pipe segment pipe. For example, the panel may include a PP or PVC layer or coating that can be directly attached to the PP or PVC of the pipe segment. If tube segment 82 is produced from another material, a different coating or layer of material may be required. There may also be one or more intermediate layers between the proximal layer or coating that deals with the pipe segment and the conductive layer, and / or there may be additional layers or distal coatings of the conductive layer as well. In general, the previous description of the sealing member is equally applicable here, and will not be repeated in its entirety.
[00095] The illustrated sealing member (e.g. panel 84) is elongated oval in shape and connected to end tube segment 82 near one end of the panel. The remaining portion of the panel ends from the end pipe segment in the recessed area of the housing 80. As explained in more detail below and shown in Figures 19, 20, 22 and 23, the housing includes an elongated access hole 92 that allows access to the panel by an actuating member for movement of the panel, after or during heating, but preferably while the sheet is still hot, and the plastic pipe segment is melted, from a sealed and closed position (Figures 19, 20 and 21) covering the open end of the pipe segment, to an open non-sealing position (Figures 22, 23 and 24), separated from the pipe segment, and exposing the open end of the pipe segment. For cooperation with such an actuation member, the panel may include an opening 85 aligned with the access hole to allow insertion of the actuation member's claw or pin through the orifice and into the opening.
[00096] The illustrated fluid conduit of the second fluid flow circuit 76 is generally constructed similarly to that of the first flow circuit 74 described above, and includes tube 96, housing 98, end tube segment 100 and sealing member 102 in the form of a panel (e.g., a laminated film or web) attached or otherwise sealingly attached to the open end of the pipe segment 100 to seal it closed. Housing 98 has an internal L-shaped flow path 104 with an inlet port for attachment to tube 96, and a discharge port for attachment to end tube segment 100.
[00097] The sealing member (panel) 102, as shown, is essentially the same as the sealing member 84 of the first fluid flow circuit, although they may differ, and only one can contain a heating member or element, if desired. The sealing member or panel 102 is attached to the end pipe segment 100 in the same manner as described with respect to flow circuit 74.
[00098] The housing 98 of the second fluid flow circuit 76 may be of any suitable configuration, but, in the illustrated embodiment, it is made of rigid plastic material and configured for attachment to the housing 80 of the first fluid flow circuit - preferably a fixation irreversible. "Irreversible fixation" means fixation in a manner that prevents separation in the normal course of use and handling, and maintains fixation, except after application of potentially large and unusual destructive forces, or manipulation not normally found in routine use. The housing 98 is generally oval, and has a flat top wall 106 and a dependent side wall 108 which define a recessed area or region within them, which can be covered by a closure or dust cover, not shown. The housing 98 is dimensioned so that it is slightly smaller than the housing 80, and can be inserted into the housing 80. For irreversible fixation, the housing 80 and 98 have interference surfaces that engage to prevent separation as described above. Specifically, as shown for illustrative purposes only, the side wall of housing 98 has flexible opposing claws 110 with end hooks or flanges 112 that bite or otherwise sit in receiving openings or notches 114 in housing 80 to prevent separation in use normal.
[00099] As best shown in Figures 18 - 20, the housings 80 and 98 are configured and dimensioned so that when fixed, the distal surfaces of the sealing members or panels 84 and 102 are pressed in direct contact face to face. Also, the resilient end tube segments 82 and 100 are located in a coaxial register opposite each other, with at least one of the tube segments and preferably both being sufficiently compressed that when the sealing members are removed between them, the (s) tube segment (s) expands in direct end-to-end contact. The face-to-face positioning of the sealing members also allows an actuating member to extend through the access hole of the housing 92 and the openings 94 in both of the sealing members in order to move both of the sealing members 84 and 102 simultaneously after heating and melting of the end-end segments 82 and 100.
[000100] As noted above, preferably, the pipe segment or segments 82 and 100 are compressed sufficiently so that when the sealing members or panels 84 and 102 are heated (such as by induction, microwave, application of direct tension or other) at the sterilization temperature, and the segments of distal end tubes melted, and the sealing members are pulled laterally between them, the segment (s) expands (m) from the compressed position, and the molten open ends of the pipe segments press joints progressively under pressure from the inherent resilience of the pipe segment material, and they fuse or weld together to form a generally permanent joint or joint between the flow paths of the two fluid flow circuits (see Figure 24). This is done relatively quickly, and the junction is formed without exposing the interior of the sterile fluid circuits to the ambient atmosphere that would render them non-sterile, thereby providing, in the preferred way, a new, highly functional and efficient screening device. sterile connection and method suitable for joining pre-sterilized fluid circuits or subassemblies to create sterile assemblies of these. As can be seen in these Figures, the sealing members are enclosed in their respective housings before fixing the housings together, and are enclosed within the housings fixed both in the closed position (Figure 20) and in the open position (Figure 23), which reduces handling waste and simplifies functionality.
[000101] Figure 25 illustrates the connection set 70 housing in combination with a mounting and receiving fixture 116. Fixture 116 can be of any desired configuration and / or associated with any desired device or piece of equipment. Fixture 116 has a recessed or recessed receiving station that generally matches the shape of the assembled housing. The fixation can be fixed to another device, such as a blood processing centrifuge used by blood banks and the like (eg, Fenwal Alyx or Amicus systems), or it can be part of a sealing device that it is devoted to producing sterile sealed joints between fluid processing components (as in the Terumo SCD Device), or it can be part of a production system for use in more basic production processes that assemble systems for subsequent consumer use. In any case, it is contemplated that the fixture 116 has an electric induction coil or microwave antenna built in it, or in another device in close proximity to it, for induction or microwave heating of the sealing members 84, 102 If resistive heating is employed, via direct voltage contacts, the fixture may have voltage contact points that are connected, via the housing to the heating element on one or both of the sealing members.
[000102] In addition, the fixture or associated apparatus may include an actuating member extending through the access hole 92 of the housing to provide automatic movement of the sealing member panels (laminates) from the closed position shown in Figure 20 to the open position shown in Figure 23, although it should be noted that manual actuation is also possible. If the part of an operation is automatic, the fixture and / or related device can include a regulator, temperature sensor, and any associated control circuit, or programmable processor for heating the sealing members and moving the sealing members to expose the open ends of the flow circuit (the open ends of the pipe segments), and form the sterile connection between the circuits. Alternative Assembly Method
[000103] The method of producing the fluid flow circuit assembly 70, preferably by sterile connection of two pre-sterilized fluid flow circuits or subsets, is one of the particularly beneficial aspects of the present subject matter. The method can be used in any suitable environment, such as a production facility in the course of producing a product for commercial sale, on-site, to allow the customer or user to assemble the product components in such a configuration as desired, or for another proposal. The resulting flow circuit assembly can be for medical fluids, including blood, intravenous solutions, such as saline or dextrose, sterile water, anticoagulants, blood component preservatives, or any other desired fluid. In a broader sense, the fluid can still be a gas.
[000104] Referring to the drawings, which represent an example of how the fluid flow circuits can be joined, the fluid flow circuit assembly 70 is preferably formed by sterile fixation of the pre-sterilized fluid flow circuits or subsets 74 and 76, which may require different sterilization or production processes, as described above, or which may be separately produced and sterilized for other reasons. As described above, the pre-sterilized flow circuits 74 and 76 each include a flow conduit in the form of tube 78, 96, a housing flow path 90, 104, and end tube segment 82, 100. The end ends of the flow ducts, that is, the material of the end-end segments is a heat-melted material, such as PP, PVC, or other thermoplastic polymeric material. Each circuit or sub-assembly also includes a sealing member 84, 102, shown in the form of a thin panel, such as a weft or multilayer film, which is attached to the pipe segment of the end end and seals the open end of the respective duct. flow. In the illustrated example, the sealing member is hermetically sealed to the end segment to maintain the interior of the respective fluid circuit sterile. At least one and preferably both of the sealing members include a heating element, such as a metal foil or film described above.
[000105] To join the fluid flow circuits in a sterile manner, any dust cover is removed from housings 80 and 98, and the housings are irreversibly fixed, such as by inserting housing 98 into housing 80 until the side hooks 112 rest on the notches or openings 114. In this position, the distal surfaces of the sealing members (for example, the distal surfaces of the panels) are in direct contact with the face, as seen in Figures 20 and 23, and one or preferably both of the end segments of tube 82, 100 are compressed.
[000106] The mounted housing or connection set 72 can then be inserted into the receiving slot of the fixture 116. Preferably, each sealing member is then heated by a power source, such as a positioned induction coil. to create a magnetic field that causes induction heating in the heating element or elements. The induction coil is preferably energized with a suitable alternating current for a time sufficient to heat the film or sheet of the heating element to a sterilization temperature, which also serves to melt the ends of the tube segments 82, 100. The film conductive cell or sheet is preferably raised to a temperature sufficient to sterilize at least the surfaces of the laminates and / or film or sheet that can be exposed to the sterile field within each of the fluid flow circuits, and specifically the sheet or film is preferably heated to at least 230 ° C and, preferably, 250 - 275 ° C and, more preferably, at least 260 ° C. Depending on the energy of the induction heating coil or other energy source and location relative to the film or leaf of the heating member, it is anticipated that less than 10 seconds, and preferably less than 5 seconds, will be required to lift the temperature to sterilize the desired surfaces. Because this occurs very quickly, this can be referred to as "instantaneous heating". At such a temperature, it is understood that only limited time, for example, less than a few seconds and, preferably, less than a second (or in this order of magnitude), is required to sterilize the surfaces of the panel and / or film or sheet. If only one sealing member has a heating element, this element will also serve to heat and sterilize the other sealing element.
[000107] As the heating element (s) is / are heated to preferably sterilize the surfaces of the sealing members, the material of the terminal end segments 82, 100 of each fluid circuit is also simultaneously heated. More specifically, the end-end segments are heated by the heating element in addition to its melting temperature, causing melt at least at the edges of the end of the tube segments. If the segments are produced from PVC, such melting will typically occur at 176 ° C or above. If higher temperatures are desired for a better sterilization range, other materials can be selected for the end-end segments of the fluid flow paths - - such as polypropylene.
[000108] After the surfaces of the sealing members / sheet or film are sterile, if desired, and the end-end segments are melted, the sealing members 84, 102 are simultaneously moved or pulled laterally between the face-end segments. In an automatic system, this can be done relatively quickly and smoothly by a movable pin or claw that extends through the access hole or slot 92 and in aligned openings 94 in each sealing member. The movement of the pin or jaw can be automatically controlled by a solenoid or other such device, or it can be done manually, if desired. As noted earlier, this movement drags each panel of the sealing member through the open end of the respective pipe segment, which exposes a surface of the panel or sheet to the lumen within the respective fluid flow circuit. However, if heated sufficiently, such surfaces have been sterilized and because they are still hot when pulled between the pipe segments, they remain sterile and do not contaminate or destroy any sterility of the fluid flow circuits. Also, due to at least one (preferably both) of the end-end resilient segments 82, 100 of each of the fluid flow circuits being compressed when the housings are connected, they (or at least one of them) expands simultaneously in direct contact. end-to-end with each other as the hot sealing members are pulled between them, and the hot end edges of the end segments are progressively pressed together, without exposing the interior of the fluid flow circuits to a non-sterile ambient atmosphere , and immediately fuse or weld together to form a permanent joint or union between fluid flow circuits.
[000109] The connection apparatus and method described above have several safety and practicality benefits in addition to those apparent from the description above. Although the material of the end segments cools quickly, the surrounding housing 80, 98 protects the joint against inadvertent user contact, or other interference with the sealing process. Also, each end tube segment 82, 100 is isolated from its respective tube 78, 96 and the rest of the fluid circuit by one of the rigid housings 80, 98. Thus, the user's movement or tube impulse 78, 96 is isolated from the sterile junction. As noted earlier, the operation of the system can be visually confirmed, if desired, by viewing the location of the sealing members through an access hole or slot 92.
[000110] The fluid circuit assembly is now ready for transferring liquids between the circuits or subassemblies, and if the fluid circuits are pre-sterilized, sterility has been maintained. No parts or parts remain for the user's disposal and no costly inserts are required. Another Alternative Embodiment
[000111] Figures 26 and 27 show another embodiment that accommodates the manual movement of the sealing members. More specifically, Figure 26 shows first and second fluid flow circuits or subsets 120, 122 to be joined. Fluid flow circuits are preferably pre-sterilized and joined in a manner that preserves sterility. The fluid flow circuit 120 includes tube 124, rigid housing 126, meltable end pipe segment 128, and sealing member (panel) 130 that seals the end of the end pipe segment. Housing 126 has an internal fluid flow path 132 with an inlet for attaching to tube 124, and a discharge for attaching to end tube segment 128.
[000112] Similarly, fluid flow circuit 122 includes tube 134, rigid housing 136, heat-melt end pipe segment 138, and sealing member 140 that seals the end of the end pipe segment. Housing 136 has an internal fluid flow path 142 with an inlet for attaching to tube 134, and a discharge for attaching to end tube segment 138.
[000113] The housings 126, 136 are configured to be joined in preferably irreversible fixation as shown in Figure 27. In the configuration shown here, the housings have burrs and complementary recesses that engage when the housings are pushed together and preferably prevent disconnection under conditions of ordinary use.
[000114] At least one of the sealing members 130, 140 includes a heating member and, as preferred, the sealing members are identical thin multilayer panels having metal foil on or near the distal surface and a sealing material fixable to the terminal tube segment on the proximal surface. The previous discussion related to sealing members applies equally to this embodiment.
[000115] The housings 126, 136 are configured and dimensioned so that when the housings are fixed, the distal surfaces of the sealing members are brought into direct contact face to face. At least one and preferably both of the end pipe segments are flexible and resilient, and compressed by the housings when the housings are attached. The heating elements of the sealing members are then heated, such as by inductive heating or resistive heating, preferably until they reach the sterilization temperature long enough to effect sterilization of the surfaces of the sealing member (for example, 260 °. C or higher). This also results in the heating of end pipe segments, raising at least the end portions of the segments above their melting temperature to a melted state. At this time, the induction heating can be terminated, and the sealing members are simultaneously gripped and pulled quickly, while still hot, between the pipe end segments. Because the portions of the sealing member panels that are pulled through the open end of the pipe segment are sterile and preferably still hot, they do not result in contamination of any of the flow circuits. As the panels exit between the pipe segments, the melted end edges of the pipe segments are simultaneously forced progressively together due to compression caused by the housings, and the molten ends of the pipe segments face to face melt or weld together to form a sterile union or permanent junction between the circuits. Antimicrobial Intensification
[000116] According to another aspect of this subject matter, the sterilization / welding process time here can be reduced in any of the above apparatus, systems and methods employing sealing members that have antimicrobial properties in whole or in part pertinent. The use of sealing members with surfaces having significant antimicrobial properties can, in theory, reduce sterilization heating times by more than 50% or more, as compared to other types of sealing members.
[000117] Antimicrobial surfaces potentially prevent or retard the growth of bacteria, viruses and fungi. While various materials may have antimicrobial properties, certain metals or metal alloys, including conductive metals that are particularly useful in the present subject matter, have significant antimicrobial properties. These metals include silver, copper, brass, stainless steel, titanium dioxide and alloys thereof, particularly silver and copper.
[000118] In the present subject matter, the sealing members may have all or a portion of their surface or heating element or member produced from material having antimicrobial properties - - particularly that portion of the surface that is exposed to the interior of the duct. fixed fluid. This portion of the surface is typically the surface that is exposed to the interior of the conduit, while the sealing member is attached to the conduit, and that is exposed to the interior of the conduit as the sealing member is moved between conjugated ends of the conduit during the sterile sealing process. Alternatively, the total proximal surface of each sealing member (which is the surface facing the conduit to which it is attached) or the total proximal and distal surfaces of the sealing members, may have antimicrobial properties.
[000119] In an implementation, a sealing member can be a single layer or sheet of uncoated or free metal having antimicrobial properties, such as copper or copper alloy. Alternatively, the sealing member may, if desired, be a laminate with the requisite surfaces having antimicrobial properties. For example, such a laminate can, if desired, include a proximal metallic surface and distal metallic surface with an intermediate layer of polymer adhesive or other material.
[000120] In a preferable aspect, the sealing member is a single layer of metal foil or film, with free and uncoated proximal and distal surfaces for total antimicrobial effect. The flow conduit of a fluid circuit, or subset of fluid circuit, can be attached to the sealing member by applying a suitable adhesive to the open end of the duct, and pressing the sealing member and duct together until the adhesive cures. . Thus, the entire surface of the sealing member exposed to the ambient atmosphere is free exposed metal, such as copper, silver, or other antimicrobial material, which exhibits inherent antimicrobial properties to substantially prevent or retard the growth of bacteria, viruses and / or fungi . Such properties can automatically provide several log reductions of cargo or biocharge contamination on the surfaces of the sealing member. The same can also be said of that portion of the sealing member that is fully enclosed within the open end of the fixed conduit. This portion, however, is typically pre-sterilized with the inside of the fixed fluid conduit, and kept sterile by connection with the open end of the conduit. The other portions of the sealing member are exposed to potential contamination from the ambient atmosphere and the antimicrobial properties of significant benefit.
[000121] Sterilization in medical applications typically requires six log reductions in microbial load. If the exposed surfaces of the sealing member provide, through an inherent antimicrobial effect, for example, three log reductions, it is only necessary for induction or other heating that is used in sterilization / welding to provide the remaining three log reductions to achieve satisfactory sterilization - - significantly reducing the amount of time required to achieve sterilization - potentially by fifty percent (50%) or more, such as sixty-six percent (66%). Such sealing members that exhibit increased antimicrobial activity can be used with any of the sets, subsets, methods, or apparatus described herein.
[000122] Although described in terms of preferred and alternative embodiments for the purpose of illustration, it is understood that other variations are within the scope of this disclosure. Such changes or variations may include, without limitation, changes in shape, configuration, regulation, materials, pressures and the like, as would be apparent to a person skilled in the art in the field of reading this description.

权利要求:
Claims (36)
[0001]
1. Method of joining first and second fluid flow circuits (16, 18; 74, 76; 120,122) to form a fluid flow circuit set (10; 70;), each fluid flow circuit (16 , 18; 74, 76; 120,122) including a fluid flow conduit (14a, 14b; 78,96; 124,134) with a lumen (15a, 15b; 132,142) and an open end (82,100; 128,138) ending in one polymeric material and a sealing member (26a, 26b; 84,102; 130,140) attached to the flow conduit (14a, 14b; 74, 76; 120,122) and sealing the open end (82,100; 128,138) of the same, which includes the steps of : (a) melt the polymeric material of the open ends (82,100; 128,138); (b) relatively moving the sealing members (26a, 26b; 84,102; 130,140) and the respective open ends (82, 1 00; 128,138) which they are sealed to expose the open ends (82,100; 128,138); and (c) bringing the exposed open ends together while melted to form a junction (12) between the fluid flow circuits (16, 18; 74, 76; 120,122) that allows fluid flow between them, characterized by the fact that that at least one of the sealing members (26a, 26b; 84, 102; 130,140) includes at least one heating element (28,68), and in which the polymeric material of the open ends (82, 100; 128, 138) is melted by heating at least one heating element (28, 68).
[0002]
2. Method according to claim 1, characterized by the fact that each of the sealing members (26a, 26b; 84,102; 1 30,140) comprises a panel fixed to the open polymeric end (82,100; 128, 138) of the respective duct ( 14a, 14b; 78,96; 124,134) and at least one of the panels comprises a metallic layer (28, 68) that defines the heating element, the method includes: positioning the polymeric ends (82,100; 128,138) of the conduits (14a, 14b; 78.96; 124.134) generally in axial alignment and with the respective panels in contact face to face, heat the metallic layer (28, 68) sufficiently to melt the polymeric material of the open end (82,100; 128,138) of each duct (14a, 14b; 78.96; 124.134), laterally move the panels between the polymer ends (82,100; 128,138) while the polymer is melted while applying an axial compressive force to the ducts (14a, 14b; 78,96; 124,134) in order to bring the open ends (8 2,100; 128,138) together as the panels are moved between them; and cooling the molten ends (82,100; 128,138) while maintaining the axial compressive force to form a joint (12) between the fluid conduits (14a, 14b; 78, 96; 124,134) which allows fluid flow between them.
[0003]
3. Method according to claim 2, characterized by the fact that the ducts (14a, 14b; 78.96; 124.134) are kept generally and laterally stationary during heating, and the panels are moved laterally between them.
[0004]
4. Method according to claim 2 or 3, characterized by the fact that the metallic layer (28, 68) is electrically conductive and heated by an inductive electrical energy source (44) operating at a selected electrical frequency , and the metallic layer (28, 68) has a thickness no greater than a skin depth for such metal at such frequency.
[0005]
Method according to any one of claims 2 to 4, characterized in that the fluid flow circuits (16, 18; 74, 76; 1 20,1 22) are pre-sterilized, and the panels and the open ends are moved relatively to each other, and the melted ends (82, 100, 128, 138) are compressed together, while maintaining the sterility of the fluid flow circuits (16, 18; 74, 76; 120,122).
[0006]
Method according to any one of claims 2 to 5 characterized by the fact that the metallic layer (28, 68) comprises a material that exhibits an antimicrobial property, and preferably, the antimicrobial property comprises at least three log reductions. microbial load related to ambient conditions.
[0007]
Method according to any one of claims 2 to 6, characterized in that the metallic layer (28, 68) is heated to at least the sterilization temperature for a time sufficient to sterilize the sealing members (26a, 26b; 84,102; 130,140) before moving the panels relative to the open ends (82,100; 128,1 38).
[0008]
Method according to any one of claims 2 to 7, characterized in that the polymeric material has a melting temperature of 230 ° C or more.
[0009]
Method according to any one of claims 2 to 8, characterized in that the panel of each of the first and second fluid flow circuits (16, 18; 74, 76; 120,122) has a plurality of layers (64, 66, 68) including a polymeric layer (64, 66) and a metallic layer (68) that defines the heating element.
[0010]
Method according to any one of claims 2 to 9, characterized in that at least one of the fluid flow circuits comprises a panel having a plurality of layers (64, 66, 68) which includes two polymeric layers (64, 66) and a metallic layer (68) that defines the heating element located between polymeric layers (64, 66), and preferably a panel having a plurality of layers including a layer (66) of polyethylene terephthalate (PET), a layer (64) of polypropylene (PP) and an aluminum layer (68) that define the heating element located between the layers of PP and PET (64, 66).
[0011]
Method according to any one of claims 2 to 10, characterized in that the panel has a thickness of less than 0.5 mm, and preferably less than 0.2 mm.
[0012]
12. Method according to claim 1, characterized by the fact that it includes sterilization of each of the first and second fluid flow circuits (16, 18; 74, 76; 120,122) before steps (a) to ( ç).
[0013]
13. Method according to claim 1 or 12, characterized in that the at least one heating element (28, 68) is heated to a sufficient temperature for a time sufficient to sterilize the sealing members. (26a, 26b; 84,102; 130,140).
[0014]
Method according to any one of claims 1, 12, or 13, characterized in that the at least one heating element (28, 68) is heated to at least 230 ° C, and preferably to at least 260 ° C.
[0015]
Method according to one of claims 1 or 12 to 14, characterized in that the at least one heating element (28, 68) is electrically conductive, and is heated by induction.
[0016]
16. Method according to any one of claims 1 or 12 to 15, characterized in that at least one of the sealing members (26a, 26b; 84,102; 130,140) comprises a metallic film (28, 68) which defines the at least one heating element
[0017]
17. Method according to any one of claims 1 or 12 to 16, characterized in that at least one of the sealing members (26a, 26b; 84,102; 130,140) is heated by an inductive electrical source (44) that operates at an electrical frequency of “f” and the at least one member (26a, 26b; 84, 102; 130, 140) includes a metallic film (28.68) that has a thickness no greater than the depth of skin for such metal at the same frequency.
[0018]
18. Method according to any one of claims 1 or 12 to 17, characterized by the fact that at least the portion of the sealing member (26a, 26b; 84,102; 130,140) that is exposed to the interior of the fluid conduit (14a , 14b; 78.96; 124.134) comprises a material that has antimicrobial properties, and preferably exhibits at least a reduction of three logs of microbial load relative to environmental conditions.
[0019]
19. Method according to any one of claims 1 or 12 to 18, characterized in that the fluid flow circuits (16, 18; 74, 76; 120,122) are pre-sterilized and the sealing members (26a , 26b; 84,102; 130,140) and open ends (82,100; 128,138) are relatively moved and the melted ends (82,100; 20 1 28,1 38) are compressed together while maintaining the sterility of the fluid flow circuits (16,18; 74.76; 120.122).
[0020]
20. Method according to any one of claims 1 to 19, characterized in that the open end (82,100; 128,138) and sealing member (84, 102; 130, 140) of each fluid flow circuit (74 , 1 20) are conducted by a housing (80,126) configured for connection to the housing (98, 1 36) of the other fluid flow circuit (76, 122).
[0021]
21. Fluid flow circuit (16, 18, 74, 76, 120, 122) for carrying out the method as defined in claims 1 to 20, wherein: a fluid conduit (14, 14a, 14b, 82, 110, 128, 138) including a lumen and including at least one open end that terminates in a heat-melt polymeric end material; a sealing member (26, 26a, 26b, 84, 102, 130, 140) that seals the open end of the conduit; characterized by the fact that: the sealing member including at least one heating element (28, 68) configured to melt the polymeric end material upon energization; and the sealing member (26, 26a, 26b, 84, 102, 130, 140) and open end of the duct (14, 14a, 14b, 82, 110, 128, 138) being relatively mobile to a non-sealing position by heating to expose the melted polymeric end material.
[0022]
22. Fluid flow circuit according to claim 21 characterized by the fact that the heating element (28, 68) is electrically conductive.
[0023]
23. Fluid flow circuit according to claim 21 or 22, characterized in that the heating element (28, 68) is conductive of heat.
[0024]
24. Fluid flow circuit according to any one of claims 21 to 23, characterized in that the sealing member (26, 26a, 26b, 84, 102, 130, 140) comprises a multilayer panel that includes at least one layer of heating element (28, 68) comprising a heating material and another layer (30, 64, 66) comprising a polymeric material compatible in a limiting manner with the polymeric end material.
[0025]
25. Fluid flow circuit according to any one of claims 21 to 24, characterized in that the heating material (28, 68) includes at least one metallic foil.
[0026]
26. Fluid flow circuit according to any one of claims 21 to 25, characterized in that it additionally includes an end housing (80, 98, 126, 132) leading to the sealing member (84, 102, 130, 140) and configured for fixation to a compatible housing of another fluid flow circuit, preferably configured for irreversible fixation.
[0027]
27. Fluid flow circuit according to claim 26, characterized by the fact that the housing is configured to allow access to the sealing member and / or conduit for movement to a non-sealing position.
[0028]
28. Fluid flow circuit according to any one of claims 21 to 27, characterized in that the heating element (28, 68) comprises a metallic layer, a portion of which is exposed to the interior of the fluid conduit ( 14, 14a, 14b, 82, 110, 128, 138), the portion of which exhibits an antimicrobial property, preferably at least a reduction of three logs of microbial load relative to environmental conditions.
[0029]
29. Fluid flow circuit according to any one of claims 21 to 28, characterized in that the polymeric end material has a melting temperature of 230 ° C or higher, preferably a melting temperature of at least 260 ° C.
[0030]
30. Fluid flow circuit according to any one of claims 21 to 29, characterized in that the sealing member (26, 26a, 26b, 84, 102, 130, 140) includes a polymeric layer ( 30, 64, 66) and a metallic layer (28, 68) that defines the heating member.
[0031]
31. Fluid flow circuit according to any one of claims 21 to 30, characterized in that the sealing member (26, 26a, 26b, 84, 102, 130, 140) includes two polymeric layers ( 30, 64, 66) and a metallic layer (28, 68) that defines the heating element located between the polymeric layers.
[0032]
32. Fluid flow circuit according to any one of claims 21 to 31, characterized in that the sealing member (26, 26a, 26b, 84, 102, 130, 140) has a thickness of less than 0.5 mm, preferably less than 0.2 mm.
[0033]
33. Fluid flow circuit according to any one of claims 21 to 32, characterized in that the sealing member (26, 26a, 26b, 84, 102, 130, 140) comprises a panel that includes a layer copper, aluminum, gold, silver, brass, stainless steel, bronze, TiO2 or an alloy of any such material.
[0034]
34. Fluid flow circuit according to any one of claims 21 to 33, characterized in that the heating element (28, 68) includes electrically conductive polymeric material.
[0035]
35. Fluid flow circuit according to any one of claims 21 to 34, characterized in that it additionally comprises an internal frangible closure (24a, 24b) disposed within the fluid conduit.
[0036]
36. Fluid flow circuit according to any one of claims 21 to 35, characterized in that at least one of the heating elements (28, 68) is configured to heat by an electrical energy source that uses alternative current at a frequency f, and includes at least one layer comprising metallic material having a thickness no greater than the skin depth of such metallic material at frequency f of the energy source.

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法律状态:
2018-12-04| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

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2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

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2020-07-28| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application according art. 36 industrial patent law|

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2020-11-24| B09A| Decision: intention to grant|

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2021-02-09| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 12/12/2012, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

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申请号 | 申请日 | 专利标题

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US201161578690P| true| 2011-12-21|2011-12-21|

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US61/578,690|2011-12-21|

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US201261585467P| true| 2012-01-11|2012-01-11|

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US61/585,467|2012-01-11|

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US201261617745P| true| 2012-03-30|2012-03-30|

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US61/617,745|2012-03-30|

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PCT/US2012/069103|WO2013096038A1|2011-12-21|2012-12-12|Fluid flow conduits and apparatus and methods for making and joining fluid conduits|

---