Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/221—Frangible or pierceable closures within tubing
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
  • A61M39/18—Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M2039/1061—Break-apart tubing connectors or couplings
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/22—Valves or arrangement of valves
  • A61M39/221—Frangible or pierceable closures within tubing
  • A61M2039/222—Frangible or pierceable closures within tubing frangible within tubing or bags
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
  • A61M39/162—Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector

Definitions

• the invention relates to a connector for producing a fluid connection with a second connector according to the preamble of claim 1 and a connector system having a first and a second connector, via which a fluid connection between at least two fluid-carrying systems can be produced, according to the preamble of claim 1 1 and Furthermore, a method for establishing a connection between at least two fluid-carrying systems by means of a first connector and a second connector according to the preamble of claim 17.
• a connector of the aforementioned type which serves for establishing a fluid connection with a second connector, includes when used as intended fluid-conducting, eg sterile system and provides in at least one connector area a weakened structure in the form of a portion of that connector area available to break the connector in this connector area (to destroy the weakened structure) and thereby establish the fluid connection with the second connector can.
• the connector may be suitable as a medical connector, in particular for the sterile connection of hose ends, syringes, cannulas and other medical assemblies.
• a medical connector usually one of the two connectors is designed as a so-called male connector, which as a further connector is a female connector is assigned, in which the male connector is introduced.
• the respective connector can also be provided with a protective cap.
• the connector may terminate a sterile system by being associated with the sterile system as a connector that does not compromise the sterility of that system.
• a fluid connection with a second connector, which is assigned to a further fluid-carrying system as a connecting element and terminates this, a fluid connection between those two systems is made possible. It is regularly provided that the second connector also terminates a sterile system.
• the resulting fluid connection is then a sterile connection between a first and a second connector, each terminating a sterile system.
• the respective connector may also be associated with a non-sterile system to close it. Furthermore, it is possible for only the one, first connector to terminate a sterile system, whereas such a requirement is not made for the second connector to be connected thereto.
• biological and medicinal substances are transferred from one closed (sterile) system to another.
• This concerns for example, the transfer of blood and / or blood components into a bag for storage, the transfer of storage solutions to blood and blood products as well as the transfer of solutions into other other systems.
• connection system for connecting at least two systems is known, which forms a male connector part, which forms a closed end of a first sterile, fluid-carrying system, and a female connector part, which forms a closed end of a second, sterile, fluid-carrying system , and which is designed to connect the two sterile systems aseptically or sterile, so that a fluid exchange between the two systems can take place.
• the two connector parts each have a predetermined breaking point, which lie one above the other in the intended assembled state of the connector parts, so that they form a common predetermined breaking point in the interior of the resulting fluid-conducting system and are breakable together to establish the fluid connection between the two closed systems.
• a disinfectant is applied to the contacting contact surfaces of the connector parts. This may additionally have bonding properties, z. B. by using a disinfectant adhesive, so that the disinfectant also serves for (permanent) connection of the two connector parts.
• the invention is based on the problem of further improving a connector of the type mentioned at the outset as well as a corresponding connector system and a method for producing a fluid connection between at least two sterile systems.
• the connector area to be weakened in a subarea is configured in such a way that its weakened structure can be generated by - at least partially - covering or irradiating the connector area with a medium.
• the formation of a weakened structure in the connector region is initially applied only by weakening a portion of that connector region specially designed to interact with the medium upon exposure of the medium to the connector region.
• a mechanically weakened structure can be generated.
• the connector region is advantageously inert to the action of the medium, thus maintaining its original stability.
• the medium may be e.g. to act a fluid or pasty medium with which the connector area is covered to produce there in a partial area of the weakened structure.
• the medium may be radiation, in particular electromagnetic radiation, with which the connector region is irradiated in order to weaken it in a partial region.
• the connector region to be weakened in a subregion has, in regions, a material which, when covering or irradiating the connector region as a whole with a medium, forms the weakened structure only in the one subregion.
• the connector region may consist of a first and of a different second material, wherein the second material is less resistant to the medium than the first material, so that the Konnekto Scheme is weakened in contact with that medium in the existing portion of the second material , For example, by in this second material by the medium, a chemical reaction is triggered or concrete stress cracks are induced.
• the connector region may consist of two different plastics, the second of which is selected such that it forms a weakened structure within the connector area, which otherwise consists of the first material, by contact with the medium.
• a connector region can be produced by casting, in particular injection molding, in one operation in a casting mold, using the so-called two-component technique (two-component technique).
• two-component technique two-component technique
• a material that when covering or irradiating with a suitable for.
• a chemical reaction triggering or stress cracking medium forms a weakened structure, are, for example, polymethyl methacrylate, polycarbonate, polyethylene, polystyrene and polysulfone.
• a disinfectant for example in the form of a fluid or pasty disinfectant or in the form of a disinfecting radiation, such as microwave or ultraviolet (UV). -Radiation.
• a disinfectant for example in the form of a fluid or pasty disinfectant or in the form of a disinfecting radiation, such as microwave or ultraviolet (UV). -Radiation.
• the disinfectant thus assumes a dual function, namely on the one hand the disinfecting of the connector in the connection with a second connector and on the other hand, the formation of a weakened structure at the connector area. In addition - apart from an already required disinfecting the connector - no additional energy input into the connector or connector area required.
• such variants of the invention are advantageous in which the weakening of the subregion of the connector region takes place by the action of the medium without additional supply of energy.
• the medium may be selected, for example, from a group which contains (low molecular weight) alcohols, polyols, fatty emulsions and buffer solutions, the latter in particular having a pH of 1 to 3 or of 1 to 13, respectively.
• the covering or wetting with a disinfectant can be done for example by spraying the connector with the disinfectant or by immersion in a disinfectant bath.
• the effect of the medium on the subregion of the connector region can be concrete in that a chemical reaction is triggered in the (mechanically) weakened subregion of the connector region, wherein, for example in the case of irradiation of the connector region with microwave or UV radiation, the medium itself does not necessarily have to be a reaction partner.
• the medium for example in the form of a fluid or pasty medium, reacts (chemically) with the material in the partial region of the connector region and thereby produces the weakened structure.
• a chemical reaction can be triggered by the medium, which itself does not directly lead to a weakening of the connector area, but which releases heat, by the action of which the connector area is weakened in the partial area provided for this purpose.
• the weakening of the connector region takes place only in the subregion of the connector region, which, for example with regard to the material, is designed for this purpose.
• the other sections of the connector area are not substantially weakened by the action of the medium. That is, outside of that portion of the connector area, for example due to the local material, advantageously inert to the action of the medium.
• the connector is fluid impermeable prior to breaching the partially weakened connector portion to make fluid communication with a second connector.
• the connector area before being covered with the medium forming the weakened structure, is initially fluid-impermeable in order to allow the formation of a (sterile) closed system, and advantageously also after being covered with the medium and the associated formation a weakened structure still remains fluid impermeable until a breakage of the connector takes place at the weakened structure.
• the connector region which is to be weakened in a subarea can therefore in particular be a closure region of the connector which closes the connector in a fluid-tight manner, e.g. by closing a fluid-carrying channel of the connector. After rupturing the connector in that closure region on the weakened structure, that channel may then serve to establish fluid communication with a second connector.
• the closure region can consist of at least two materials, one of which is weakened during the covering or irradiation with a medium provided for this purpose, so that the closure region forms a weakened structure in a corresponding partial region.
• the existing of a different material other sections of the connector area are not weakened contrast.
• the connection of the connector with an associated second connector can be done by mating, in particular axial mating, and / or mutual rotation, for example, a positive connection, such as a snap-in connection, a bayonet, etc., or even a screw, for example using a corresponding thread can be produced.
• a positive connection such as a snap-in connection, a bayonet, etc.
• a screw for example using a corresponding thread can be produced.
• For screwing the connectors to be joined together can also be an additional connector, z. B. in the form of a union nut.
• the opening or breaking of the connector area at its weakened structure can be done on the one hand directly when connecting the connector to a second connector, z. B. by puncturing the weakened structure, by radial strain of the weakened structure at or after passing through a bottleneck or by torsional stresses during rotation of the two connectors to each other.
• a break of the connector area along the weakened structure only after connecting to a second connector, for. B. manually or by means of a tool provided.
• a projection provided for piercing the weakened structure of the one connector of the second connector to be connected therewith may in turn itself have a weakened structure in order to be able to break off this projection and, if appropriate, also to achieve a fluid permeability of the second connector.
• a connector system for establishing a fluid connection between at least two fluid-carrying, in particular sterile, systems via two connectors, each of which is assigned to one of the two systems, is characterized by the features of claim 11.
• Advantageous embodiments of the connector system result from the dependent claims.
• a method for producing a connection between at least two fluid-carrying, in particular sterile, systems by means of a first connector and a second connector, each of which conclude a sterile system, is specified in claim 17.
• Advantageous developments of the method emerge from the dependent claims.
• the one (male) connector into the other (female) connector plug in and make a connection.
• This may for example be a positive connection, in particular in the form of a latching connection, z.
• the connection can in particular be designed so that the two connectors can not be released from each other again by a (rectilinearly acting) longitudinal or axial force.
• FIG. 1 is a perspective view of a connector system with a first connector and a second connector according to a first embodiment of the invention in Vietnamesekonnektiertem state;
• FIG. 2 shows a cross section through the connector system from FIG. 1;
• FIG 3 shows a cross section through the connector system of Figure 1 in a connected state.
• FIG. 4 is a perspective view of a connector system with a first connector and a second connector according to a second embodiment of the invention in Vietnamesekonnektiertem state.
• FIG. 5 shows a cross section through the connector system of Figure 4; 6 shows a cross section through the connector system of Figure 4 in a connected state.
• Figure 7 is a schematic representation in cross section of a connector system with a first connector and a second connector according to a third embodiment of the invention in Vietnamesekonnektiertem state.
• FIG. 8 shows the connector system from FIG. 7 in the connected state
• FIGS. 1 to 3 show a connector system 2 in a first embodiment.
• the connector system 2 is used to establish a connection between two (not shown in the figures) fluid-carrying, possibly sterile, systems.
• the connector system 2 makes it possible to connect two sterile systems in a sterile manner even in a non-sterile environment.
• the connector system 2 can be used for medical applications, such as for the sterile connection of syringes, cannulas, tubes, medical devices and other fluid-carrying medical devices.
• the connector system 2 comprises a first connector 4 and a second connector 6, which can be connected to each other along a flow direction S (axially).
• the first connector 4 is used for connection to an associated fluid-conducting, possibly sterile system and for this purpose has a channel 12 which is to be brought into fluid communication with the associated fluid-carrying system, cf. FIGS. 1 and 2.
• the first connector 4 is designed to establish a fluid connection with the second connector 6, in particular in order to establish a fluid connection between the fluid-conducting system assigned to the first connector 4 and a fluid-conducting system assigned to the second connector 6.
• the fluid-conducting connection to the second connector 6 is also concerned in particular with the Producing a fluid connection between the channel 12 of the first connector 4 and the second connector 6.
• the channel 12 can thus in the embodiment result in the fluid-carrying connection between the first connector 4 associated fluid-carrying system and the second connector 6 and the associated further fluid-carrying system.
• the channel 12 - and thus the first connector 4 - is closed according to Figure 2 by a connector portion 18 in the form of a closure region, which is exemplified by a disc 19.
• the connector region 18 which closes the first connector 4 or, more specifically, its channel 12, has a subregion 20 which can be weakened by the action of a suitable medium.
• a suitable medium for example, has an effect.
• the first connector 4 closes the associated fluid-conducting system in a fluid-tight manner.
• the first connector 4 and the second connector 6 each have a first connection end 8 and a second connection end 10.
• the first connection end 8 serves to connect the first connector 4 and the second connector 6 to a respective fluid-conducting, possibly sterile, system.
• the first connector 4 and the second connector 6 are initially fluid-impermeable and close off the respective sterile system.
• the respective second connection end 10 of the first connector 4 and the second connector 6 is provided to establish a connection between the two connectors 4, 6.
• This connection is configured here by way of example as a detachable connection.
• a union nut 1 1 with internal thread and at the second connection end 10 of the other connector 6, 4th a corresponding external thread (not shown) is provided.
• the internal thread and the external thread can be replaced or supplemented by a grid, whereby a - at least axially - non-detachable connection can be produced.
• the locking can be done using a tool.
• the first connector 4 has a channel 12 extending along the flow direction S, via which the fluid connection can be established both with the associated fluid-conducting system and with the second connector 6.
• the channel 12 opens on the one hand into a rear connector element 14, which forms the first connection end 8, and on the other hand into a front, present female, connector element 16, which forms the second connection end 10.
• the first connector 4 is thus in terms of its function in the connector system 2 in the exemplary embodiment, a female connector.
• the rear connector element 14 may be designed to connect a fluid-carrying system male or female.
• the channel 16 is closed by a connector region 18 acting as a closure region, so that the first connector 18 closes off the associated fluid-conducting system.
• the rear connector element 14 and the front connector element 16 are separated from one another by the connector region 18 (fluid-impermeable) arranged in the channel 12 and acting as a closure region.
• the connector region 18 is configured in the exemplary embodiment as a disk 19, which in the present case extends substantially transversely to the flow direction S over the cross section of the channel 12.
• the connector region 18 is integral with further, e.g. the channel 12 and / or the Konnetechnischsenden 8, 10 forming, formed or shaped sections of the connector.
• the connector region 18 is designed to form a weakened structure in the first connector 4 in a subregion 20 of the connector region 18.
• the weakened structure can be generated by covering the connector region 18 (partially or in total) with a medium.
• the resulting weakened structure 20 is configured to be breached by the application of an external force and thus to open the channel 12 to establish fluid communication. In particular, this creates a fluid connection between the rear connector element 14 and the front connector element 16 within the connector.
• the connector region 18 has at least one first material and at least one second material as a closure region, which has a have different resistance to the medium to be applied.
• the second material (lower resistance) forms the weakened portion 20 of the connector portion 18 and is distributed as a pattern in the first material (greater resistance).
• the pattern of the second material specifies the geometry of the weakened structure to be formed.
• the remaining portions of the connector area 18 are made of the first material.
• the first material may e.g. Polyamide (PA), polyetheretherketone (PEEK), polyethylene terephthalate (PET), polypropylene (PP) or polyphenylene sulfide (PPS).
• the first material may also correspond to the material of at least parts of the remaining first connector 4 (outside the closure region).
• the second material may e.g. Polymethyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), polystyrene (PS) or polysulfone (PSU).
• PMMA Polymethyl methacrylate
• PC polycarbonate
• PE polyethylene
• PS polystyrene
• PSU polysulfone
• the medium may, for example, a disinfectant, including in particular all disinfectants officially approved by the Paul Ehrlich Institute, such as Diosol ® or Descoderm ®, a polyol, a fatty emulsion, an (low molecular weight) alcohol or a buffer solution, in particular with a pH value of 1, 5 to 2.5 or 1 1, 5 to 12.5.
• a disinfectant including in particular all disinfectants officially approved by the Paul Ehrlich Institute, such as Diosol ® or Descoderm ®, a polyol, a fatty emulsion, an (low molecular weight) alcohol or a buffer solution, in particular with a pH value of 1, 5 to 2.5 or 1 1, 5 to 12.5.
• the medium may be radiation which advantageously disinfects, for example microwave or UV radiation.
• the reduced resistance of the second material has the consequence that upon contact of the second material with one of the aforementioned media, the second material is dissolved by the medium, partially dissolved and / or weakened in some other way.
• the medium can trigger a chemical reaction in the second material and optionally react with the second material.
• the weakened second material then forms a weakened structure in the subregion 20 of the connector region 18.
• the weakened structure may e.g. tend to form stress cracks when the connector portion 18 is subjected to mechanical stress.
• the connector portion 18 is adapted to release fluid communication through the channel 12 upon application of an external force.
• the connector region 18 with the weakened structure advantageously remains fluid-impermeable.
• the weakened structure forming portion 20 may assume different geometries. Some examples are shown in Figures 9a to 9j, described below. Alternatively, other suitable geometries are conceivable.
• the geometry of the partial region 20 is preferably selected such that the resulting weakened structure does not divide the connector region 18 into two or more completely separate sections 24.
• the portion 20 and the resulting weakened structure expediently interruptions 26, which ensure that in existing fluid permeability of the channel 12 after breaking through the connector portion 18, so in the embodiment in the existence of a fluid connection between the rear connector element 14 and the front connector element 16, as far as possible all sections 24 of the connector region 18 (permanently) remain connected to the channel 12 and preferably pressed against the inner boundary wall. This prevents that individual sections 24 of the connector portion 18 get into the fluid connection as freely movable elements. As a result, there should be no sharp edges in the channel 12, nor should particles escape from the connector 4 and get into the channel 12.
• the opening created in the channel 12 at the steep end of the open connector region 18 should be large enough so as not to interfere with the passage of the fluid carried therein; it should therefore pass blood cells, for example in the case of blood transports.
• the second connector 6, as well as the first connector 4 has a extending along the flow direction S channel 12, which serves to establish a fluid connection with the associated fluid-carrying system or with the other, first connector 4 and in the embodiment on the one hand in a back Connector element 14, which forms the first Konnetationsende 8, and in a front connector element 22, which forms the second Konnetationsende 10 opens.
• the second connector 6 differs from the first connector 4 mainly in that the channel 12 terminates with a front connector element 22 in the form of a male connector element.
• the second connector 6 is thus a male connector with regard to its function in the connector system 2.
• the rear connector element 14, which serves for connection to a fluid-conducting, in particular sterile, system, can be male or female.
• the rear connector element 14 and the front connector element 22 are separated from one another by a connector region 18 arranged in the channel 12 in the case of the second connector 6.
• the connector region 18 is arranged at the boundary between the front connector element 22 and the channel 12.
• the connector region 18 of the second connector 6 accordingly again forms a closure region for closing the channel 12, so that the connector 6 can terminate the associated fluid-conducting system in a fluid-tight and optionally sterile manner.
• the connector portion 18 of the second connector 6 is thus provided on the one hand to the rear connector element 14 and the male connector element 22 fluid-impermeable to separate from each other, and he is on the other hand suitable to targeted, that is under external force, a fluid connection via the channel 12, ie in the embodiment between the rear connector element 14 and the male connector element 22, release.
• the connector region 18 of the second connector 6 has, as a closure region, a disk 19 which, in the exemplary embodiment, extends essentially transversely to the flow direction S over the cross section of the channel 12.
• the connector region 18 in the form of a closure region additionally comprises a predetermined breaking point 28 in the exemplary embodiment.
• the predetermined breaking point 28 is displaced here in the flow direction S with respect to the disk 19, in such a way that the disk 19 is closer to the front connector element 22 than the latter Predetermined breaking point 28.
• the predetermined breaking point 28 results from a - material running in peripheral and transverse to the flow direction S - material taper in the outer surface of the second connector 6.
• the predetermined breaking point 28, for example also be provided on the inner surface of the second connector 6.
• the predetermined breaking point 28 is configured such that it does not lead to a breakage of the second connector when connecting the first connector 4 and the second connector 6 (FIG. 3), but is broken by applying force transversely to the flow direction S (manually or by means of a tool) can be, to form a fluid connection between the first connector 4 and the second connector 6.
• the connector region 18 of the second connector 6 may be designed such that the connector region 18 only forms a weakened structure upon contact with a suitable medium.
• the first connector 4 is a female connector and the second connector 6 is a male connector. According to a variant, however, the first connector 4 may also be male and the second connector 6 may be female.
• FIGS. 4 to 6 show a connector system 2 in a second embodiment.
• the second embodiment differs from the first embodiment in particular in that the front (male) connector element 22 of the second connector 6 has an undercut 30 and the front (female) connector element 16 of the first connector 4 has an associated abutment surface 32.
• the stop surface 32 is formed in that the channel 12 of the first connector 4 has a larger inner diameter than the adjoining front connector element 16. According to one embodiment, the inner diameter of the channel 12 of the first connector 4 corresponds at least to the outer diameter of the front connector element 22 of the second connector.
• connection between the first connector 4 and the second connector 6 of the connector system 2 according to the second embodiment is not solvable by the action of force in the axial direction. This results from the geometry described above, according to which the undercut 30 engages behind the abutment surface 32. According to a variant, a grid for non-detachable connection of the first connector 4 and the second connector 6 is provided on the inside of the second Konnetationsendes 10 of the first connector 4 and on the outside of the second Konnetechnischsendes 10 of the second connector 6.
• both the first connector 4 and the second connector 6 may have a connector region 18 which only forms a weakened structure in contact with a suitable medium in a subregion 20.
• the connector area 18 of the first connector 4 e.g. in the form of a disc, present at the boundary between the channel 12 and the front connector element 16 substantially transversely to the flow direction S.
• the connector portion 18 of the second connector 6 terminates the second connecting end 10 of the front connector element 22.
• the connector region 18 of the first connector 4 or of the second connector 6 may have a prefabricated predetermined breaking point instead of a partial region 20 to be weakened.
• the first and the second embodiment of the connector system 2 are not limited to the respectively described type of connection of the first connector 4 and the second connector 6. Rather, for both embodiments in addition to a detachable connection, for example by screwing, also a non-detachable connection of the connectors 4, 6, for example by positive locking, possible.
• FIGS. 7 and 8 show a detail of a connector system 2 in a third embodiment.
• the third embodiment differs from the first and second embodiments in that the connector regions 18 of the first connector 4 and the second connector 6 to be brought into contact with a medium to form a weakened structure do not comprise a disk-shaped closure region.
• the connector regions 18 are rather formed by (closed) end sections of the front connector elements 16, 22 of the first connector 4 and of the second connector 6; and they have a substantially conical shape.
• the shape and dimensions of the connector elements 16, 22 of the first and second connectors 4, 6 to be connected together are matched to one another such that in the connected state of the connector system 2 (FIG. 8) the outer surface of the front male connector element 22 of the second Connector 6 rests against the inner surface of the front, female connector element 16 of the first connector 4.
• the connectors 4, 6 are fluid-impermeable in the respective connector region prior to formation of the weakened structure in order to enable the fluid-tight sealing of a fluid-carrying, possibly sterile, system.
• the connectors 4, 6 remain fluid-impermeable even after covering with the medium and the associated formation of a weakened structure, until the connectors 4, 6 break apart at the weakened structures.
• the partial region 20 of a respective connector region 18 to be weakened with the medium extends peripherally on a section of the front female connector element 16 or of the front male connector element 22 which is spatially limited along the flow direction S.
• the respective partial region 20 does not extend over the entire circumference of the This is to prevent that when breaking the weakened structure, a part of the respective connector element 16, 22 is completely separated from the remaining connector 4, 6 and could hinder the fluid connection thus generated.
• the connector regions 18 of the first connector 4 and of the second connector 6 are preferably at the same height in the flow direction S, so that together they define a common connector region.
• the common connector region can be broken in a subregion 20 of the connector regions 18, for example by buckling of the connector system 2.
• the first connector 4 and the second connector 6 each have a stop 34 which indicates to a user whether the connector elements 16, 22 are intended to abut each other. In the connected state, the stops 34 of the first connector 4 and the second connector 6 come to rest.
• the connectors 4, 6 of the connector system 2 shown in FIGS. 7 and 8 are connected together by frictional connection.
• connecting elements may be provided on the connectors 4, 6 in order to enable a releasable or non-releasable form-fitting or other connection.
• one of the two connectors 4, 6 instead a weakened structure forming portion 20 having a prefabricated predetermined breaking point.
• the connector elements 14, 16, 22 of the connectors 4, 6 in the present case have a conical shape.
• these connector elements 14, 16, 22 of the ISO 594 standard are corresponding Luer connectors.
• larger-sized connectors can be provided.
• the portion 20 to be weakened forms a ring, in particular in a circular shape, with at least one interruption 26 (FIG. 9a).
• a radially extending ring segmenting e.g. halving, be provided line, whereby a further interruption 26 may be provided.
• the line may be straight ( Figure 9b) or curved, e.g. S-shaped (Fig. 9c), run.
• the ring is replaced by a plurality, e.g. two (Fig. 9d) or four (Fig. 9e), radially extending, advantageously at least partially straight lines into parts, in particular the same parts, divided, wherein the ring corresponding quadruple (Fig. 9d) or eight times (Fig.
• the portion 20 to be weakened forms a radially and circumferentially three-fold interrupted ring (Fig. 9f).
• Another embodiment provides for the sub-region 20 at least two perpendicular to each other and radially extending lines, each two adjacent ends of the radial lines are connected by arcuate, circumferentially extending lines each with an interruption 26 (Fig. 9g).
• the partial area 20 to be weakened forms a regular polygon, e.g. Octagon, with an interruption 26 ( Figure 9h).
• one (FIG. 9i) or two (FIG. 9j) radially extending line (s) dividing the polygon into (equal) parts is conceivable, and accordingly two (FIG. 9i) and four (FIG. Interruptions 26 may be provided.
• FIGS. 10a to 10d Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10d Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10d Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10 b Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10d Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10 b Various embodiments for the cross-sectional geometry of the connectors 4, 6 are shown in FIGS. 10a to 10d.
• FIGS. 10a to 10 b Various embodiments for the cross-section
• the geometry of the weakened structure and the cross-sectional geometry of the connector 4, 6 are e.g. depending on the size of the connector 4, 6 and the application of the connector 4, 6 selected.
• first connector 4 and the second connector 6, in the embodiment via the respective first connection end 8, are each connected to a fluid-conducting, optionally sterile system.
• the first connector 4 and the second connector 6 are initially fluid-impermeable and thus close the respective fluid-conducting system.
• the first connector 4 and the second connector 6 are initially in not interconnected state before, see Figures 1 and 2.
• the covering can be done by spraying.
• the respective connector 4, 6 are also immersed in the medium.
• the purpose of this step is to bring the second material of the connector region 18 of the first connector 4 into contact with the medium in order to produce a weakened structure there.
• the first connector 4 and the second connector 6 can be disinfected superficially. Examples of a suitable medium, in particular in the form of a disinfectant, have already been given above.
• the medium acts on the connector region 18 of the first connector 4 to be weakened in a subregion 20, and in particular also on its second material.
• the preferred exposure time depends on the geometry, the structure and the dimensions of the connector area 18 and can be, for example, between 5 s and 60 s.
• the medium acts on the connector region 18 in such a way, for example by dissolving or partially dissolving the second material, that in a subregion 20 the weakened structure of the Connector area 18 is created.
• the shape of the weakened structure is determined by the distribution of the second material in the first material, and thus, for example, regardless of an impact of the medium on the connector 4 also outside of the weakened portion 20.
• the connector portion 18 with the now generated weakened structure is still fluid impermeable as long as no external force acts on the connector region 18 to break it.
• the first connector 4 and the second connector 6, in the present case via the respective second connection end 10, are connected to one another (FIG. 3).
• the front, male connector element 22 of the second connector 6 penetrates (in the axial direction) the weakened structure of the first connector 4. This leads to a rupture of the connector portion 18 of the first connector 4 into individual sections 24.
• the sections 24 are through the front , Male connector element 22 pressed against the inner wall of the channel 12 of the first connector 4 (not shown) and remain connected via the interruption (s) 26 of the weakened structure with the connector portion 18 of the first connector 4.
• the first connector 4 and the second connector 6 are connected to each other by twisting.
• a torsional stress in the connector region 18 can be built up, which leads to the rupture of the weakened structure.
• the first connector 4 is fluid-permeable, so that a joint connection with both the associated fluid-carrying system and with the second connector 6 is made possible.
• the first connector 4 and the second connector 6 are screwed together in the connected state by means of a union nut or non-detachably connected to each other by means of a positive locking. If the first connector 4 and the second connector 6 are connected to each other by twisting, the last two steps can also take place simultaneously.
• the predetermined breaking point 28 of the second connector 6 is broken by a force exerted radially to the flow direction S, possibly by means of a tool. This happens, for example, by a kinking of the front, If the connector region 18 of the second connector 6 has no predetermined breaking point 28 but a weakened structure produced by applying a medium, the weakened structure of the second connector 6 is similarly broken. As a result, a fluid connection between the first connector 4 and the second connector 6 - and thus between the associated fluid-carrying systems - made.
• step four not only the weakened structure of the first connector 4 but advantageously also that of the second connector 6 is broken when connecting the connectors 4, 6.
• the connector portion 18 of the second connector 6 due to the reduced compared to the outer diameter of the front, male connector element 22 inner diameter of the front female connector element 16 of the first Connector 4 radially compressed so that a radial force on the connector portion 18 and the weakened structure forming portion 20 acts. This leads to a breaking of the weakened structure by radial compression.
• the breaking of the weakened structure of the second connector 6 is not effected by the compression in the front female connector element 16 of the first connector 4 but only when the front male connector element 22 of the second connector 6 reaches the channel 12 of the first connector 4.
• the channel 12 of the first connector 4 has a larger inner diameter than the front, female connector element 16 of the first connector 4, so that the compressed connector portion 18 of the second connector 6 relaxes again. This leads to a breaking of the weakened structure by radial relaxation.

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• 2013
  • 2013-08-16 US US14/424,537 patent/US20150217104A1/en not_active Abandoned
  • 2013-08-16 EP EP13750070.8A patent/EP2890441A1/de not_active Withdrawn
  • 2013-08-16 CN CN201380045543.9A patent/CN104768605A/zh active Pending
  • 2013-08-16 WO PCT/EP2013/067119 patent/WO2014032991A1/de active Application Filing

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