EP3458126A1 - External functional device - Google Patents
External functional deviceInfo
- Publication number
- EP3458126A1 EP3458126A1 EP17724331.8A EP17724331A EP3458126A1 EP 3458126 A1 EP3458126 A1 EP 3458126A1 EP 17724331 A EP17724331 A EP 17724331A EP 3458126 A1 EP3458126 A1 EP 3458126A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- external functional
- functional device
- housing body
- cassette
- blood
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
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- 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
-
- 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
- A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
- A61M1/159—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit specially adapted for peritoneal dialysis
-
- 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
- A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
-
- 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
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M1/342—Adding solutions to the blood, e.g. substitution solutions
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36222—Details related to the interface between cassette and machine
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36225—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with blood pumping means or components thereof
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362262—Details of incorporated reservoirs
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362263—Details of incorporated filters
- A61M1/362264—Details of incorporated filters the filter being a blood filter
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362265—Details of valves
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36226—Constructional details of cassettes, e.g. specific details on material or shape
- A61M1/362266—Means for adding solutions or substances to the blood
-
- 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
- A61M1/3622—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit
- A61M1/36224—Extra-corporeal blood circuits with a cassette forming partially or totally the blood circuit with sensing means or components thereof
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
- A61M2205/121—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit interface between cassette and base
-
- 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
- A61M2209/00—Ancillary equipment
- A61M2209/08—Supports for equipment
Definitions
- the present invention relates to an external functional device according to claim 1.
- the invention particularly relates to an external functional device which has at least one housing body with at least one integrated therein chamber for receiving medical fluids and at least one latching device for releasably receiving an accessory. background
- the cleaning of the equipment used in blood treatments can be technically complicated. In order to ensure adequate hygiene with acceptable work and for other reasons external functional devices, such as blood cassettes are used.
- Such a blood cassette may be designed to perform as many functions as possible in the preparation and execution of blood treatment procedures.
- Such blood cassettes are familiar to the person skilled in the art, for example, from WO 2010/121819 or EP 2 227 270.
- other accessories such as valves, medical ports or patient or dialyser connections, connected via tubing.
- the tubing is rolled up and secured with, for example, adhesive strips to allow safe packaging and sterilization of the device.
- adhesive strips prevent accessories from falling to the floor and becoming contaminated there.
- the use of adhesive tape results in the packaging of the blood cassette to increased material and labor.
- these adhesive strips must be removed and disposed of.
- Object of the present invention is to provide a further external functional device, which has a simplified handling and thus increased security.
- the external functional device may be, but is not limited to, a blood treatment cassette.
- Other possible embodiments of the present invention include fluid or pump cassettes for peritoneal dialysis cyclers.
- the functional device is an organizer, a tray or a treatment kit for hemofiltration machines. The object according to the invention is achieved by an external functional device having the features of claim 1.
- the external functional device comprises at least one housing body, at least one integrated into the housing body chamber for receiving medical fluids, at least one integrated into the housing body channel for receiving and / or guiding a medical fluid and at least one fully or partially integrated in the housing body valve means for controlling or Controlling a fluid flowing through the external functional device and at least one latching device for releasably receiving an accessory connected to the housing body via a hose line.
- housing body refers to a three-dimensionally shaped body formed from a material suitable for use in a medical treatment process, such as a blood treatment process, such as a plastic material be produced by a casting or injection molding process.
- the term "chamber” refers to a volume suitable for holding at least one medical fluid
- the volume may be a closed space or circumscribed by it, but it may also be an open space or space be partially surrounded, and only by the presence of another body - other than the housing body - to a closed or closed up to supply or discharge lines for the fluid space.
- Chambers may be designed and provided to receive valves and / or sensors or the like.
- the term “conduit” or “conduit” refers to equipment suitable for receiving and / or delivering medical fluids, such as blood, heparin or other drugs, saline, substituate, and the like.
- Channels or lines may be configured in sections as closed and / or semi-open structures. They can be closed, for example, by means of a cover device on at least one open side and thus designed to be sealable against, for example, components of a blood treatment device and / or against the atmosphere.
- the term “valve device” refers to a device suitable for controlling or controlling the passage of fluids through conduits and / or chambers of the external functional device. For example, control can be automated, and suitable control or regulating devices can be provided in or on the blood treatment apparatus.
- releasable latching refers to latching designed as hand-releasable connections and serves to properly locate components during manufacture for further assembly with other components, for alignment within the overall structure. Disposables and to maintain alignment within the disposable packaging from the time of manufacture through to sterilization, storage, transport and unpacking, they are handled correctly during the unpacking of the disposable according to the instructions for hygiene, such as Touch and / or care protection and, if necessary, protection against disinfectants in places not intended, and for the correct and ergonomically correct upgrade of the treatment machine with the departmentsdisposable.
- catches can prevent dropping of disposable components during upgrade handling. This is especially true for accessories that are connected via hoses to a treatment cassette. Catches can also be part of the correct mounting of a disposable component during treatment on other disposable components, for example on a treatment cassette or at designated locations of the treatment machine.
- the fact of the latched bracket means that it is next to the correct spatial Arrangement in the latched state, for example, for the purpose of improved accessibility to a Zuspritzstelle (septum) or for the purpose of detecting the assembled state or the switching position of a disposable valve via a machine sensor, also arrives on the Entrastbarkeit.
- the Entrastles an accessory allows the use of the unlatched component at a location further away, for example, the use of a septum, and possibly also on the ergonomic and geometrically correct re-latching at the old or possible new additionally provided resting points during the Disposable production or during medical treatment.
- Locking can also be designed as non-detachable connections. In this case, it may be that the separate production of two components is cheaper or more functionally required and that the permanent locking causes the actual finished state of use.
- a latching can be unsolvable in certain directions of movement, remain movable in other directions of movement, for example, for rotational movements between the latched components, and thus serve to produce a mechanically or sensory functional system.
- the term "accessory connected to the housing body” refers to an accessory such as valves, medical ports or patient or dialyzer ports connected to the housing body, preferably via a tubing
- a medical port may include a main channel having a lumen for directing a first fluid through the port, and further having a subchannel mouth of a subchannel for adding a second fluid into the main channel, the port being at least one housing member and at least one actuating element arranged to be transferable relative to the housing element from a first position to a second position, and wherein the port has a sealing portion which is arranged to move from a position into the position when the actuating element is transferred dere between a first position of the sealing portion, in which the sealing portion the Side channel opening not occlusive or covered (open position) and a second position of the sealing portion in which the sealing portion closes the side channel mouth in the second position or covered (closed position) to be rotatable.
- a functional device can be understood to mean a device by means of which functions such as the routing of fluid by means of lines, valves, interception of clots and / or the like is possible.
- An external functional device can be understood to mean a device which is not a permanent component of a treatment device.
- An external functional device is rather externally connected to the treatment device for the purpose of treatment.
- the external functional device is a blood cassette as is familiar to the person skilled in the art, for example, from WO 2010/121819.
- the external functional device is provided on at least one of its surfaces with a cover device which is part of at least one integrated valve device.
- the cover device is non-positively and / or positively and / or materially connected at least in one section with the housing body.
- the cover device can be connected to the housing body, for example, by means of a circumferential weld or other circumferential connection. It may also be provided with the housing body further non-circumferential or punctiform or local welds or connections (eg, gluing or compression) of the cover device.
- the cover device is connected in certain areas on both sides of structures (at least one structure) to the external functional device, in particular to the housing body. Both sides can be understood according to the invention as at least two sides of the respective structure.
- a bilateral connection can be understood as meaning at least two-fold connection in the region, in particular immediate region, or in the environment, in particular the immediate environment, of the structure.
- Fluid channels, lines or other elements of the external functional device include i.a. Fluid channels, lines or other elements of the external functional device. These preferably include those elements which are designed to be open in a cross-section perpendicular to the main extension plane of the cover device and / or covered by the cover against an exterior or the atmosphere.
- the two-sided connection can be a weld. It may each be fluid-tight, e.g. in such a way that no fluid exchange, in particular no fluid exchange, can take place over the joining region (region in which, for example, was glued or welded) of the compound.
- the bilateral connection may be for individual fluid channels, conduits or other elements, e.g. in selected areas of external
- Functional device be provided; it may be provided for a majority thereof or for all fluid channels, conduits or other elements.
- a two-way connection can be a connection both to the left and to the right of the corresponding structure. It may be provided both above and below with respect to the structure or the like.
- a bilateral joint may be one, two or more welds along the edge or perimeter or extent of at least one structure or portion thereof.
- a bilateral connection may be elongated or elongated, in whole or in portions thereof.
- the expenditure required for pressing the external functional device can be advantageously reduced in certain embodiments according to the invention.
- the demands on the precision with which the contact pressure of the external functional device, for example to a blood treatment device advantageously be lower.
- the contact pressure of the external functional device for example to a blood treatment device
- a more reliable function of valves acting on channels covered by the bilateral connection may advantageously be achieved.
- a covering device may in particular be a foil.
- the film may preferably be a plastic film.
- any laser-weldable film which appears suitable to the person skilled in the art may be considered.
- the external functional device may have ports for communicating with an extracorporeal circuit in fluid communication.
- the external functional device can in particular be designed as a cassette to or for a blood treatment.
- the external functional device by means of two connectors with at least one - preferably two - peristaltic pump (s) in fluid communication can be connected.
- Roller pumps may be suitable peristaltic pumps.
- the external functional device can have at least one - preferably two - pumping tube segment (s) or can be configured or provided for receiving such.
- the external functional device has at least one valve device which has at least one web and a section of the cover device.
- the web is designed on the housing body.
- the bridge and covering device are arranged to be actuatable by means of an actuator of a blood treatment device acting on a web for changing a fluid flow in the sense of a valve.
- Such a “bridge” may be a component integrated into the external functional device or projecting from a surface thereof in any direction describe. This can be formed from the same material as the external functional device.
- a web can be configured, for example, during the production of the external functional device by means of casting or injection molding.
- the fluid which flows through the external functional device in its use is a substituate, heparin or another pharmacologically active substance, saline (in particular 0.9% NaCl solution), blood, air and combinations thereof.
- the external functional device can in particular be coupled to a blood treatment device. Further preferably, it can be designed and provided to be connectable to the blood treatment device by means of a receiving device of the blood treatment device.
- the external functional device can in particular be coupled to the treatment device with the surface facing the covering device.
- the external functional device can be coupled backwards at an angle of inclination, preferably between 5 ° and 11 °, in particular at an angle of inclination of substantially or exactly 8 ° with respect to a vertical to the blood treatment device.
- the external functional device is preferably inclined backward in an upper area thereof (in the use state).
- the external functional device has at least one substituate addition point, which has a contact protection element and / or a drip protection.
- Other sections, in particular any other section, of the external functional device may also have a contact protection element and / or a drip protection.
- a closure function of the ports (one, some or all ports) of the external functional device can also be realized by septa or check valves.
- the drip protection can be realized for example by an integrated closure sleeve.
- the drip guard may preferably be used to prevent dripping or running out of substituate or blood or a mixture of substituate and blood during the removal of the external functional device from the receiving device of the blood treatment device. In this way, a hygienic handling of the used and impure external functional device can also be guaranteed outside the treatment device.
- the external functional device according to the present invention may be suitable for use in a blood treatment method using double-needle access or single-needle access.
- the patient's blood is preferably passed out of the patient through the dialyzer during the withdrawal phase, thereby dialyzed (preferably immediately) after passing through the dialyzer in the single-needle cannula and stored there in the
- the blood is thereby dialyzed in the "fresh" state in which it comes out of the patient.
- the method carried out by means of the cartridge according to the invention for blood treatment may advantageously differ from those conventional methods in which blood is taken from the patient, this in a separate Stored single-needle chamber, then dialyzed and returned to the patient via a venous air separator.
- the external functional device may preferably have at least one single-needle chamber in which a blood surge redirecting element is arranged.
- Such a “blood flow diverting element” or blood surge element may be suitable and provided for achieving a flow slowdown, generating turbulence and / or diverting the blood flowing into the single needle chamber or canceling the pulse of the blood surge be designed. It may be configured, for example, in the form of an ellipsoidal or round column, which is connected at at least a portion of its circumference to a wall of the single-needle chamber.
- the external functional device of the present invention may preferably comprise at least one venous blood chamber.
- the single-needle chamber may preferably be located above, based on the orientation of the external functional device during its use, the venous blood chamber.
- the venous blood chamber may be divided into at least one upper space and at least one lower space by means of a cross-sectional taper of the housing body.
- the upper space and the lower space may be in fluid communication with each other.
- the upper space may be configured to allow or allow tangential inflow of fluids flowing through the external functional device produce.
- the upper space may have a region for generating a stable rotational flow of the fluids flowing through the external functional device.
- the lower space may have a region that is substantially or completely free of rotational flow of the fluids flowing through the external functional device.
- walls or wall portions of the upper space and / or the lower space of the venous blood chamber may be adapted to a slope of the external functional device against a vertical of the blood treatment device. This may advantageously allow for flow-optimized flow or flow of the blood through the venous blood chamber and the rise of air possibly in the blood for the purpose of separation.
- the venous blood chamber may be configured and, in particular, have an air separation effect as described in the Applicant of the present invention in Patent Application 10 2009 024 465.4 entitled “Air Separator, External Function Device, Blood Circulation and Treatment Apparatus", issued June 10, 2009 to the German Patent and Trademark Office (DPMA), the entire contents of which are hereby incorporated by reference.
- DPMA German Patent and Trademark Office
- the housing body is designed as a hard part.
- the hard part may be a housing body made substantially of one piece and a material. This can be an injection molded part. It may have a minimum strength casting speed of more than 400 N / mm 2, preferably 1200 1800 N / mm 2 have (flexural modulus of elasticity).
- the pressure in the extracorporeal blood circulation upstream of the dialyzer can be measured through the covering device or foil.
- the external functional device may preferably be a disposable article which is disposed of after a single use.
- FIG. 1 shows a side view of an external functional device according to the invention provided on its front side with a covering device according to a preferred embodiment
- Fig. 2 shows the external functional device of Figure 1 with unfolded after destructively cutting open the cover device.
- Fig. 3 shows the external functional device of Fig. 1 and Fig. 2 from its rear side;
- FIG. 5 shows, schematically simplified, the functional unit 1000 in plan view with the accessory 799 snapped in place.
- the hose connection between the accessory 799 and the functional unit 1000 is not shown;
- Fig. 6 shows schematically simplified the functional unit 1000 in section along the line AB with snapped-on accessory 799.
- the hose connection between the accessory 799 and the functional unit 1000 is not shown;
- Fig. 7 shows schematically simplified the accessory 799 from below with the openings 797th
- the external functional device is a blood cassette as is familiar to a person skilled in the art, for example from WO 2010/121819.
- Fig. 1 shows a side view of an external functional device, which is provided on the surface, which is looked in Fig. 1, with a cover device.
- the external functional device is designed here as an example as a cassette 1000.
- the cassette 1000 has a hard part 1. As shown by way of example in FIG. 1, the hard part 1 has chambers, channels and valves. As shown by way of example in FIG. 1, the chambers, channels and valves are integrated into the hard part 1 or designed at least partially by the hard part 1.
- the cassette 1000 of FIG. 1 is provided on its front side with a covering device, here for example a film 3.
- the cover means may be planar, i. plan, be welded to the hard part 1.
- the covering device can close off the chambers and / or channels of the hard part 1 of the cassette 1000, namely with respect to a side of the covering device facing away from the hard part 1 and / or with respect to the atmosphere.
- the film rests against a circumferential sealing web 4 on the hard part 1 of the cassette 1000.
- the film 3 is welded to a circumferential weld 5 with the hard part 1 of the cassette 1000.
- the circumferential sealing bar can alternatively be performed exposed.
- the film 3 may be connected to the hard part 1 of the cassette 1000 at further local welds (not shown). These may also be circumferential, that is closed in the sense of a final boundary similar to a ring, and / or punctiform.
- the film 3 can be connected at local points point or line with the hard part of the cassette 1000, z. B. welded, be, in particular at the edge zones of the liquid-carrying channels.
- the film 3 may be laser welded to the hard part of the cassette 1000. It is advantageous if the local heat input takes place using light-absorbing components.
- the light-absorbing component can be part of the material of the film and / or of the hard part or a layer which is arranged between the film and the hard part or over the film.
- the layer may be a foil layer.
- the cassette 1000 may be coupled to a blood treatment device (not shown in FIG. 1) at least with the front side shown in FIG.
- a blood treatment device (not shown in FIG. 1) at least with the front side shown in FIG.
- An exemplary approach for properly coupling a cartridge 1 to a docking surface of a blood treatment device is described in patent applications 10 2009 012 633.3 entitled “Device for Joining an External Functional Device with an Arrangement, Arrangement Having Such Device and Method of Bonding" And 10 2009 012 632.5 entitled “Sealing Device for Sealing a Volume of a Medical Device against Another Volume and Arrangement and Method", also filed with the DPMA on March 10, 2009 the disclosures of which are hereby incorporated by reference.
- the cassette 1000 can be coupled to the plane of the film 3 - or via this - to a coupling surface of the blood treatment device.
- the coupling surface may preferably be designed in three dimensions.
- the coupling surface of the blood treatment apparatus can, for example, at an upper portion thereof in FIG. 1 by 8 ° to a backward in Fig. 1 from top to bottom extending vertical (in Fig. 1 extending from the viewer in the plane in) be inclined.
- the cassette 1000 has an arterial patient port 7.
- the cassette 1000 has an arterial pressure measuring chamber 9. This may have corresponding sensors.
- the sensors can preferably transmit signals via a cabling.
- the sensors can also be designed so that they transmit wireless signals.
- the cassette 1000 has a connector 1 1 for the blood outlet from the cassette 1000 and a connector 13 for the blood inlet into the cassette 1000.
- the two connectors 1 1 and 13 are connectable to a pump tubing segment or set a blood pump.
- the cassette 1000 also has a chamber 15 with a pressure measuring point for pressure measurement in the extracorporeal blood circulation in front of the dialyzer ("pre-filter”) or after the pump ("post-pump”).
- the cassette 1000 has an arterial filter line 17 and a venous filter line 19.
- the interior of the cassette 1000 has a venous blood chamber 21.
- the venous blood chamber 21 is divided into an upper space 23 and a lower space 25.
- the upper space 23 of the venous blood chamber 21 may allow a laterally tangential blood inflow.
- blood can flow laterally through the inlet (the left side in FIG. 1) into the upper space 23 and spread tangentially to the walls of the upper space 23.
- a laterally tangential blood inflow may create a zone of substantially or fully stable rotational flow of the blood in the upper space 23 of the venous blood chamber 21.
- the lower space 25 of the venous blood chamber 21 may constitute a calming zone for blood flow. It is possible that there is substantially no or no rotational flow of the blood in such a calming zone.
- the venous blood chamber 21 is divided into the upper space 23 and the lower space 25 by a cross-sectional taper 27 of the hard part 1 of the cartridge 1000.
- the cross-sectional taper 27 reduces the cross-section of the venous blood chamber 21 in its width and depth such that a rapid flow occurs, after the passage of which a fluid flowing through the venous blood chamber 21 of the cassette 1000 assumes a slower flow velocity.
- the upper space 23 and the lower space 25 are in fluid communication.
- Walls of the upper space 23 and the lower space 25 of the venous blood chamber 21 may suitably be inclined to the vertical direction of the upper portion of the cassette 1000 in FIG. 1, for example, an inclination of the upper portion of the cassette 1000 shown in FIG ° to the back (into the plane of the drawing). They may be suitably rounded in such a way that they advantageously represent a flow-optimized contact surface for fluids which flow through the venous blood chamber 21.
- the cassette 1000 has a clot catcher 29.
- a clot trap may preferably be used, such as that disclosed in the Applicant of the present invention in Patent Application 10 2009 024 495.6 entitled “Clot Trap, External Function, Blood Flow, and Treatment Apparatus” filed with the DPMA on June 10, 2009 , the disclosure of which is incorporated herein by reference in its entirety.
- the pressure in the extracorporeal circuit can be measured through the film 3 or over the film 3, ie in particular after passing through the dialyzer.
- the cassette 1000 has a venous patient port 31.
- the cassette 1000 has an arterial heparin addition site 33.
- the heparin addition site 33 (as well as a venous heparin addition site 37) may also be suitable and intended for the addition of pharmacologically active substances other than heparin, which are only preferably anticoagulants, or combinations of active substances. This is always to be considered even if heparin is mentioned in any context before or in the following.
- the cassette 1000 has a check valve 35 of the arterial heparin addition site 33.
- Exemplary check valves for use as Check valve 35 of the arterial heparin addition site 33 and as further check valves of the cassette 1000 are in the patent application 10 2009 024 469.7 of the present applicant entitled "Valve device, valve core, external functional device, treatment device and method", the 10th June 2009 filed with the DPMA, the disclosures of which are hereby incorporated by reference.
- the cassette 1000 has an arterial heparin adding valve 36. With the aid of the arterial heparin addition valve 36, the addition of heparin into the arterial filter line 17 can be controlled or regulated.
- the support webs may serve to support the cassette in the coupled state to a blood treatment device against a lid of a receiving device of the blood treatment device for receiving the cassette.
- Exemplary embodiments of such a coupling of the cassette to the blood treatment device are described in patent application 10 2009 012 633.3 entitled "Apparatus for Connecting an External Functional Device to an Arrangement, Arrangement Having Such Device and Method of Bonding", published on Mar. 10, 2009 DPMA, the disclosure of which is hereby incorporated by reference.
- the cassette 1000 is shown as the user / viewer looks at them after being coupled to the machine interface.
- the inclination of the cassette 1000 to the machine is "tilted backwards" so that the top edge is farther away from the user / viewer than the bottom edge.
- the upwardly facing surfaces of the venous blood chamber 21 and the single-needle chamber 57 accordingly have an inclination such that air bubbles can still rise reliably on the inside despite the inclination of the cassette 1000.
- a cassette design is also possible, which does not provide a tilt of the cassette.
- the blood treatment device has an external functional device, for example the cassette 1000 explained in FIGS. 1 to 3 with the elements described above in FIGS. 1 to 3.
- FIG. 4 schematically illustrates latch 798 on functional unit 1000.
- latch 798 includes a tab 797 which engage openings 796 of accessory 799, respectively. With the lugs 797 Verrastvornchtung 798 the accessory 799 is positively and / or non-positively attached to the functional device 1000.
- FIG 5 shows, schematically simplified, the functional unit 1000 in plan view with the accessory 799 snapped on.
- the hose connection between the accessory 799 and the functional unit 1000 is not shown.
- Fig. 6 shows schematically simplified the functional unit 1000 in section along the line AB with snapped-on accessory 799.
- the hose connection between the accessory 799 and the functional unit 1000 is not shown.
- the locking of the accessory 799 on the functional device 1000 is designed as a releasable latching.
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Urology & Nephrology (AREA)
- Emergency Medicine (AREA)
- External Artificial Organs (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102016006089.1A DE102016006089A1 (en) | 2016-05-20 | 2016-05-20 | External functional device |
PCT/EP2017/060785 WO2017198480A1 (en) | 2016-05-20 | 2017-05-05 | External functional device |
Publications (1)
Publication Number | Publication Date |
---|---|
EP3458126A1 true EP3458126A1 (en) | 2019-03-27 |
Family
ID=58737556
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP17724331.8A Withdrawn EP3458126A1 (en) | 2016-05-20 | 2017-05-05 | External functional device |
Country Status (5)
Country | Link |
---|---|
US (1) | US20200197591A1 (en) |
EP (1) | EP3458126A1 (en) |
CN (1) | CN109152876A (en) |
DE (1) | DE102016006089A1 (en) |
WO (1) | WO2017198480A1 (en) |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6929751B2 (en) * | 2002-05-24 | 2005-08-16 | Baxter International Inc. | Vented medical fluid tip protector methods |
SE0303416L (en) * | 2003-12-18 | 2005-06-19 | Gambro Lundia Ab | Packaging intended for use in a peritoneal dialysis treatment and process for making such a package |
JP5372938B2 (en) * | 2007-09-19 | 2013-12-18 | フレゼニウス メディカル ケア ホールディングス インコーポレーテッド | Dialysis system and related parts |
AU2007344891B2 (en) | 2007-12-21 | 2012-08-09 | Gambro Lundia Ab | Disposable extracorporeal blood circuit and apparatus for the extracorporeal treatment of blood |
MX347636B (en) * | 2008-10-30 | 2017-04-03 | Fresenius Medical Care Holdings Inc | Modular, portable dialysis system. |
DE102009012633A1 (en) | 2009-03-10 | 2010-09-23 | Fresenius Medical Care Deutschland Gmbh | Device for connecting an external functional device to an assembly, having an arrangement comprising such a device, and method for connecting |
DE102009012632A1 (en) | 2009-03-10 | 2010-09-23 | Fresenius Medical Care Deutschland Gmbh | A sealing device for sealing a volume of a medical treatment arrangement against another volume and arrangement and method |
DE102009024465B4 (en) | 2009-06-10 | 2015-03-05 | Fresenius Medical Care Deutschland Gmbh | Blood cassette with air separator, blood circulation and treatment device |
DE102009024495A1 (en) * | 2009-06-10 | 2010-12-16 | Fresenius Medical Care Deutschland Gmbh | Blood clot catcher for external function device, blood circuit and treatment device, has strainer surface for collecting blood clots in fluid flowing through strainer surface |
DE102009024467B4 (en) * | 2009-06-10 | 2015-12-31 | Fresenius Medical Care Deutschland Gmbh | Device and external functional device and treatment device for the treatment of medical fluids |
DE102009018664A1 (en) * | 2009-04-23 | 2010-10-28 | Fresenius Medical Care Deutschland Gmbh | External function device i.e. blood treatment cassette, for use in dialyzing device, has non-return valves, addition valves and single-needle blood valve that are integrated in housing body for controlling fluid passing via device |
EA022698B1 (en) * | 2009-04-23 | 2016-02-29 | Фрезениус Медикел Кеэ Дойчланд Гмбх | Blood treatment cassette |
DE102009024469A1 (en) | 2009-06-10 | 2011-01-05 | Fresenius Medical Care Deutschland Gmbh | Valve device for injecting e.g. drugs into blood conducting passages of blood treatment cassette of blood treatment apparatus for extracorporeal blood treatment, has valve insert formed so that insert is switched among three valve states |
DE102009024466A1 (en) | 2009-06-10 | 2010-12-16 | Fresenius Medical Care Deutschland Gmbh | Medical fluid i.e. blood, receiving apparatus, has inflow opening introducing fluid into inner area of apparatus, and fluid surge diverting element comprising body for dividing fluid surge of inflowing fluid into two partial fluid surges |
DE102010032179A1 (en) * | 2010-07-23 | 2012-01-26 | Fresenius Medical Care Deutschland Gmbh | Connector, medical treatment device, medical device function and method |
DE102010032182B4 (en) * | 2010-07-23 | 2016-09-29 | Fresenius Medical Care Deutschland Gmbh | Purge line, medical device function, medical treatment device and method |
DE102011010249A1 (en) * | 2011-02-03 | 2012-08-09 | Fresenius Medical Care Deutschland Gmbh | Medical device |
DE102011108787A1 (en) | 2011-07-29 | 2013-01-31 | Fresenius Medical Care Deutschland Gmbh | Medical port, blood tube for use in extracorporeal blood treatment and medical treatment device |
DE102011108781A1 (en) * | 2011-07-29 | 2013-01-31 | Fresenius Medical Care Deutschland Gmbh | Touch protection device for medical fluid-carrying cassette and cassette |
-
2016
- 2016-05-20 DE DE102016006089.1A patent/DE102016006089A1/en not_active Ceased
-
2017
- 2017-05-05 US US16/303,557 patent/US20200197591A1/en not_active Abandoned
- 2017-05-05 WO PCT/EP2017/060785 patent/WO2017198480A1/en unknown
- 2017-05-05 EP EP17724331.8A patent/EP3458126A1/en not_active Withdrawn
- 2017-05-05 CN CN201780031259.4A patent/CN109152876A/en active Pending
Also Published As
Publication number | Publication date |
---|---|
DE102016006089A1 (en) | 2017-11-23 |
WO2017198480A1 (en) | 2017-11-23 |
US20200197591A1 (en) | 2020-06-25 |
CN109152876A (en) | 2019-01-04 |
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