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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
  • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
  • A61M1/1654—Dialysates therefor
  • A61M1/1656—Apparatus for preparing dialysates
  • A61M1/1668—Details of containers
• • 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
  • A61M39/223—Multiway valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2048—Connecting means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/22—Arrangements for transferring or mixing fluids, e.g. from vial to syringe with means for metering the amount of fluid
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3643—Priming, rinsing before or after use
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3643—Priming, rinsing before or after use
  • A61M1/3644—Mode of operation
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/3643—Priming, rinsing before or after use
  • A61M1/3644—Mode of operation
  • A61M1/3647—Mode of operation with recirculation of the priming solution
• • 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
  • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
  • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
  • A61M1/3621—Extra-corporeal blood circuits
  • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
• • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
  • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
  • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
  • F16K11/00—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves
  • F16K11/02—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with all movable sealing faces moving as one unit
  • F16K11/06—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with all movable sealing faces moving as one unit comprising only sliding valves, i.e. sliding closure elements
  • F16K11/072—Multiple-way valves, e.g. mixing valves; Pipe fittings incorporating such valves with all movable sealing faces moving as one unit comprising only sliding valves, i.e. sliding closure elements with pivoted closure members
• • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
  • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
  • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
  • F16K31/00—Actuating devices; Operating means; Releasing devices
  • F16K31/44—Mechanical actuating means
  • F16K31/60—Handles

Definitions

• the present invention relates to the filling device of a fluid line system or fluid system, in particular of an extracorporeal blood treatment device, for example a dialysis machine or an apheresis machine, according to the preamble of claim 1.
• a blood treatment device such as a dialysis machine, must be filled with a liquid, such as a NaCl solution or other sterile physiological solution prior to connection to a patient, such that air pockets in the system are vented to a system fluidly connected to the system Patients would be dangerous. Furthermore, that can
• Blood treatment device performed as part of a filling - circulation cycle.
• liquid containers preferably exist in the form of
• Plastic bags that are specially designed for extracorporeal blood treatment devices of this pertinent genus to the u. a. as defined above
• Such liquid containers are also manufactured and sold by the assignee of the present application.
• Such a liquid container usually has a liquid receiving chamber and two preferably closable liquid connections.
• a first of the two connections can be connected to an arterial line section and to the second connection a venous line section of the hydraulic system (fluid system or else referred to as fluid line system) of the extracorporeal blood treatment device can be connected.
• the fluid bag and the two conduit sections together form a circulation device of the extracorporeal blood treatment device.
• the arterial line section is first connected to the first fluid port of the bag, and after opening the first fluid port, the hydraulic system is filled.
• the venous line section of the system initially remains open to the atmosphere or is connected to a drain, a container or a bag, so that air in the system can escape / vent.
• the fluid flows through intrinsic filtration devices that contain residual air bubbles with the fluid
• the venous line section of the hydraulic system can be disconnected again from the second fluid port of the fluid bag and the fluid in the hydraulic system can be rinsed out again while constantly supplying fluid from the reservoir.
• Line sections can be separated from the fluid bag and applied to the patient for treatment.
• the fluid bag remains in the system circuit, ie, the fluid in the system Fluid bag or through the fluid chamber is circulated. This may possibly contaminate the fluid stored in the fluid bag.
• a new fluid bag is used with fresh, uncontaminated fluid for the following filling / circulation cycle, whereas the fluid bag is disposed of for the previously performed filling / circulating cycle, regardless of its
• fluid bags for blood treatment devices relate quasi one
• Port can be disconnected from the fluid bag and connected to an arterial patient access.
• Blood treatment machines may be provided, but others as well Fluid line systems such as heart-lung machines, infusion systems, etc. may affect and therefore should be multifunctional.
• Liquid system preferably an extracorporeal blood treatment device (dialysis machine), a heart-lung machine, etc. with the features of
• Claim 1 solved. Furthermore, the further object is achieved with a fluid conduit system according to claim 12. Advantageous embodiments of the invention are the subject of the dependent claims.
• the basic idea of the present invention is to design the generic filling device of a fluid line system, in particular of an extracorporeal blood treatment device, such that a conventional (low-cost) fluid container of known design, such as a conventional NaCl bottle or a corresponding bag with only a single puncturable / konnektierbaren
• the fluid barrier device is constructed to pass through a
• Fluid flow in Spikeströmungscardi ie from the dotted fluid container to the spike port for the fluid line system automatically closes and can be selectively opened by a mechanical actuation mechanism against the fluid flow.
• This actuating mechanism is preferably constructed so as to quasi connect with / by connecting the fluid conduit system to the spike / spike port
• the actuating mechanism releases the fluid barrier device so that it is closed by the short-term / slightly downstream fluid from the fluid container.
• the fluid barrier means is disposed in the fluid port of the spike for the fluid conduit system and adapted to be disconnected from the co-operating fluid port of the spike
• Fluid line system to be operated in the open position.
• the fluid barrier means and more particularly the check valve, has an axially movable valve body inserted into the spike and preferably into the spike's spigot and a valve seat acting in the spike flow direction from the valve body by fluid flow / pressure can be closed.
• the valve body further has an actuator, which preferably projects through the valve seat and adapted for, from a line section or its connection for a
• the check valve is designed such that it is brought into an open position by connecting a line section of the fluid line system and by the connection process (mechanically)
• Fluid container and is then held by the build-up dynamic pressure in the closed position.
• a biasing device such as a spring, helical compression spring, or a
• Elastomer or the like may be arranged, which the valve body in his
• the check valve does not necessarily have to be a seat valve, but according to another aspect of the present invention may be designed as a sliding or rotary valve, in which case the valve body is designed as a valve spool with at least two switching positions ,
• the valve housing in this case would have an input and an output, which are connected or separated according to the switching position of the valve spool. D. h., In the one switching position, the valve coil establishes a connection between the spike and the pipe connection, whereas in the other switching position, this connection is interrupted. Also in this case, the valve spool
• Such possibly spring-loaded, mechanically / manually or hydraulically actuated 2-way / 2-position switching valves are generally known per se from hydraulics, so that can be dispensed with a detailed design description at this point.
• the (mechanical) actuation of the Ventiairess takes place according to another aspect of the present invention preferably via the connection of the line section or via the line section (fluid line system) itself
• Actuation can take place directly or via an interposed actuating element which is movably arranged in the spike and in particular in the spike-own connection is. In the latter case, it is possible to arrange the actuating element so that it can be operated manually with a disconnected line section for opening the check valve, for example, to flush or for closing the check valve in case of malfunction (hanging of the valve body).
• the spike can remain on the conventional medical fluid container after puncturing of the container closure, due to the arrangement of the automatically closing fluid barrier device, which automatically opens the spike, by connecting the fluid line section to the spike, whereas the line section can optionally be attached to the fluid barrier device or to the spike can be connected for a filling process of the fluid line system and then clamped again by the fluid barrier device / spike without fluid (or only a small / negligible amount of fluid) is lost from the medical fluid container. After the line section is uncoupled from the spike outlet port (e.g., Luer lock port), the line section may immediately thereafter
• the liquid container or its stored liquid / fluid can also be used for several successive treatments / filling operations, depending on its filling volume. Furthermore, the medical
• Liquid container provided, for example, compared to the specially prepared for extracorporeal blood treatment equipment containers with two connections is cheaper.
• Fig. 1 conceptually shows a fluid system of an extracorporeal blood treatment device according to a preferred embodiment of the invention, according to which the blood side Systenn Scheme for a filling process according to the "single-pass principle" to a
• Fluid source liquid container
• FIG. 2 shows a fluid barrier device according to a preferred embodiment.
• Embodiment of the invention which is integrated in a spike for connecting the blood-side system area to a conventional liquid container.
• an extracorporeal blood treatment device for example a dialysis machine, heart-lung machine, etc., has an internal hydraulic
• fluid line system through which, for example, a blood cleaning fluid (dialysis fluid) is passed during a treatment phase on the machine side and blood flows extracorporeally in the opposite direction on the patient side, wherein the machine-side and patient-side conduit system region in the case of a dialysis machine by a dialyzer ( Filter) are fluidically isolated.
• a blood cleaning fluid dialysis fluid
• Filter dialyzer
• the fluid line system (system area) on the blood / patient side a venous and an arterial line section 2, 4, preferably each tube section with each end arranged / trained connections (eg Luer lock connections) 6, 8, to the example injection needles or cannulas (not shown) can be connected as patient access, which are insertable into a patient's body.
• a filling device can be connected to the extracorporeal blood treatment device 1, by means of which the patient-side
• Fluid line system is usually rinsed / cleaned before each patient treatment.
• the filling device according to the present invention, a liquid source, preferably in the form of a universal liquid container (NaCI bottle) 10 with a single outlet 1 1, the present Embodiment by means of a so-called spike 12 (see FIG. 2) of the filling device is punctured to tap liquid from the liquid container 10.
• the spike 12 has, according to FIG. 2, an (outlet) port 20, preferably in the form of a luer-lock connection, to which the arterial
• Line section 2 is temporarily connected for a filling and / or rinsing process.
• the spike 12 and its connection 20 for the line section 2 are shown conceptually in FIG.
• the spike 12 has a piercing portion in the form of a hollow needle or cannula 14, to which the port 20 immediately downstream connects.
• the connection (Luer lock connection) 20 and the cannula 14 are in this case to one
• the spike connection 20 is also conceivable to form the spike connection 20 as a simple slip-on sleeve, onto which the line section can be pushed, for example, in the form of a flexible hose. Also, any other connection structure known structure is conceivable.
• the spike 12 and, preferably according to the present
• Embodiment within the terminal 20 is a receiving space 16th
• fluid-barrier device 30 will be described below as an integral part of the spike 12 / spike port 20, it is generally conceivable to provide the fluid-barrier device 30 as a separate cartridge as simply described in the following description. in the receiving space 16) is used, for example, to equip / retrofit a conventional spike with the fluid-locking device according to the invention.
• the fluid-blocking device according to the invention 30 according to the preferred embodiment of the invention, a valve body 32 with a plate, cone or spherical seat portion 34, in the axial direction of the spike 12 in the direction of the spike port 20 an actuating element, in this case, for example Shape of a rod or pin 36 preferably in one piece
• valve body 32 is axially movable within the receiving space 16 taken and can be flowed through by a liquid from the liquid container 10 or.
• a valve seat 40 is formed downstream of the valve body 32, with which the valve body 32 in its downstream movement sealingly engageable to lock a valve passage 38 in the valve seat 36.
• the rod-shaped actuating element 36 has an outer diameter which is smaller than the diameter of the valve passage 38, so that the actuating element 36 can project through the valve passage 38 to form a flow annular gap 42 and protrude from the spike connection 20.
• a biasing spring 44 is preferably arranged, which presses the valve body 32 against the valve seat 40.
• Dialysis machine are first filled with a liquid, such as a NaCl solution for subsequent patient treatment, the arterial line section is first connected to the terminal 20 of the spike 12 according to the invention.
• a liquid such as a NaCl solution for subsequent patient treatment
• the arterial line section is first connected to the terminal 20 of the spike 12 according to the invention.
• this is done by a kind of union nut 46, which is screwed onto the terminal 20 while the (hose) line 2 presses into the port 20 fluid-tight.
• hose clamp 50 which temporarily seals the line system after uncoupling from the spike 12, until the line system is connected to the patient access.
• the housing of the spike 12 protects the moving parts of the check valve 20 and thus preserves its
• the spike 12 according to the invention forms a
• valve 20 described above is presently represented as a seat valve with valve body 32 and valve seat 40.
• valve body does not necessarily have to be a plate, but may also take the form of a ball, a cone, etc.
• check valve described also as a
• Sliding or rotary valve be known structure in which instead of the valve body shown an axially or radially to the spike 12 movably mounted
• Valve piston is provided which selectively connects the cannula 14 to the output terminal of the spike 12 in a first, mechanically actuated position and interrupts the connection between cannula 14 and spike connection in a second, mechanically unactuated position. Also, the valve piston may be spring biased on one side in the blocking position.
• an extracorporeal blood treatment device (1), the following
• Components has:
• a spike 12 adapted for connecting the single fluid port of a medical fluid container 10 of the fluid system, and a manually operable fluid barrier means 30 located immediately downstream of the spike 12, preferably integral with the spike 12 and adapted or intended to remain fluidly connected to the spike (12) during operation of the filling device, wherein
• the fluid-barrier device 30 has at least one fluid outlet connection adapted for a line section / hose 2 of the
• Fluid line system preferably the arterial line section of
• Blood purification device during operation of the filling device is detachably connected thereto.

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• Health & Medical Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Engineering & Computer Science (AREA)
• General Health & Medical Sciences (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Biomedical Technology (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Cardiology (AREA)
• General Engineering & Computer Science (AREA)
• Pharmacology & Pharmacy (AREA)
• Physics & Mathematics (AREA)
• Fluid Mechanics (AREA)
• Mechanical Engineering (AREA)
• Urology & Nephrology (AREA)
• Pulmonology (AREA)
• Emergency Medicine (AREA)
• External Artificial Organs (AREA)

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• 2013
  • 2013-04-19 DE DE202013101695U patent/DE202013101695U1/de not_active Expired - Lifetime
• 2014
  • 2014-01-13 DE DE102014100326.8A patent/DE102014100326A1/de active Pending
  • 2014-01-13 DE DE102014100324.1A patent/DE102014100324A1/de not_active Withdrawn
  • 2014-04-16 EP EP14719264.5A patent/EP2806917A1/de not_active Withdrawn
  • 2014-04-16 WO PCT/EP2014/057747 patent/WO2014170380A1/de active Application Filing
  • 2014-04-16 CN CN201480022293.1A patent/CN105120919B/zh active Active
  • 2014-04-16 EP EP14718079.8A patent/EP2869868B1/de active Active
  • 2014-04-16 WO PCT/EP2014/057748 patent/WO2014170381A1/de active Application Filing
  • 2014-04-16 US US14/784,791 patent/US9446182B2/en active Active
  • 2014-04-16 CN CN201480022314.XA patent/CN105120920B/zh active Active
  • 2014-04-16 US US14/784,463 patent/US9579441B2/en active Active

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