WO2022074049A1 - Disposable und system mit einem port - Google Patents
Disposable und system mit einem port Download PDFInfo
- Publication number
- WO2022074049A1 WO2022074049A1 PCT/EP2021/077539 EP2021077539W WO2022074049A1 WO 2022074049 A1 WO2022074049 A1 WO 2022074049A1 EP 2021077539 W EP2021077539 W EP 2021077539W WO 2022074049 A1 WO2022074049 A1 WO 2022074049A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- lumen
- connector
- port
- opening
- section
- Prior art date
Links
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Classifications
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- 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
- A61M1/1601—Control or regulation
- A61M1/1619—Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
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- 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
- A61M1/154—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 with sensing means or components thereof
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- A—HUMAN NECESSITIES
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- 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
- A61M1/1601—Control or regulation
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- A—HUMAN NECESSITIES
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- 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
- A61M1/1621—Constructional aspects thereof
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- 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
- A61M1/168—Sterilisation or cleaning before or after use
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- 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
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- A—HUMAN NECESSITIES
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/15—Detection of leaks
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- A—HUMAN NECESSITIES
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/18—General characteristics of the apparatus with alarm
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- A—HUMAN NECESSITIES
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- 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
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3337—Controlling, regulating pressure or flow by means of a valve by-passing a pump
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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
- 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
Definitions
- the present invention relates to a disposable according to claim 1 and a system according to claim 7 . It also relates to a rinsing cap and a medical treatment device as disclosed herein.
- Medical treatment devices regularly have one or more ports. Lines are connected to them in order to convey liquids out of the interior of the medical-technical treatment device, or vice versa.
- One-way lines are referred to as disposables.
- One object of the present invention is to specify a further disposable that is suitable for this purpose.
- another system should be specified.
- a rinsing cap and a medical treatment device are disclosed.
- the object according to the invention is achieved by a disposable having the features of claim 1, also by means of the flushing cap disclosed herein, which is also part of the present invention and can be claimed accordingly.
- the object according to the invention is also achieved by a system having the features of claim 7 .
- a disposable which has a fluid line and a connector with a connector lumen.
- the disposable is used to fluidly connect the Fluid line with a first lumen of a first fluid guide of a port.
- the port in turn has a second lumen.
- This is used to hold a section of a connector, the connector having a contact protection sleeve with a free connection opening, the connector lumen surrounded by a wall ending in an opening inside the contact protection cover, the free connection opening and the opening of the wall forming one
- the system according to the invention has a disposable according to the invention. It also has a port which is used to establish a fluid connection between at least one fluid line of a medical treatment device that is assigned to, faces or is included in the interior of the treatment device and a connector of a fluid line that is also included in the disposable according to the invention.
- the fluid line does not belong to the treatment device, but rather is associated, faces or is associated with the exterior of the treatment device.
- the fluid line of the disposable can be, for example, a hose set or a part thereof, a substitute line or the like.
- the port has, mostly in an end section thereof, a first fluid guide, which is or comprises a first lumen through which flow can take place in its longitudinal direction, with a first end opening or opening plane.
- the fluid guide is provided for receiving and/or guiding a medical fluid and for establishing the fluid connection with the connector.
- the port also has a second fluid guide that is provided further outward (relative to the port) relative to the first fluid guide.
- the second fluid guide comprises at least one second lumen and a second end opening or opening level. The first fluid guide is therefore further inside the port than the second fluid guide, in any case the first end opening is further inside the port than the second end opening.
- the first end opening of the first fluid guide is arranged, at least in sections, in the second lumen of the second fluid guide.
- the present invention also relates to a plug-in system with a receiving part, e.g. B. the port mentioned here, and with a part to be inserted here, e.g. B. the connector mentioned herein.
- the female part has a rim, preferably raised, which is annular in a first portion with an inner radius, a second portion of the rim not being part of the inner radius annular shape formed by the first portion.
- the male part has a disc structure which is preferably round or has a round edge section with an outer radius which corresponds to a value between 90% and 99.9% of an inner radius of the female part and/or at most 1 mm, preferably at most 0 5 mm, particularly preferably 0.1 mm, is smaller than the inner radius of the first section, and/or wherein the outer edge section or the outer radius of the disk structure is at most 1 mm, preferably at most 0.5 mm, in particular preferably at a distance of 0.1 mm from the first section of the edge.
- the present invention also relates to a method for disconnecting or separating the rinsing cap from the port or for preparing this disconnection or separation, which can be carried out using the devices disclosed herein.
- the method includes providing a system according to the invention, wherein the flushing cap is plugged onto or into the port.
- the method further includes introducing air or sterile air into the port using a compressor prior to disconnecting the irrigation cap.
- the initiation can be initiated automatically by the control device of the treatment device; a corresponding open-loop or closed-loop control can be prepared.
- the aim of introducing it can be to introduce compressed air into the port before separating the flushing cap to empty liquid and thus to remove a large part of the liquid still present in the port by displacing it from the port with the compressed air.
- the method may further include disconnecting the irrigation cap from the port. Disconnecting can be accomplished using and moving the pivoting lever as disclosed herein.
- Embodiments according to the invention can have some, some or all of the following features in any combination, unless this is technically impossible for a person skilled in the art.
- Advantageous developments of the present invention are each also the subject matter of the dependent claims.
- the object according to the invention has one or more features in a specific embodiment, it is also disclosed here in each case that the object according to the invention expressly does not have this or these features in other embodiments that are also according to the invention has e.g. B. as a disclaimer. It is therefore true for each embodiment mentioned herein that the opposite embodiment, formulated as a negation, for example, is also revealed.
- the plug-in system according to the invention can be further developed in embodiments with any feature disclosed herein in any combination.
- the port or the attachment section preferably has a preferably raised edge that can protrude beyond adjacent housing sections, can be set back relative to these, or can end flush with them.
- the second opening is optionally set back relative to the edge or relative to the adjacent housing sections. The latter can prevent the entry of liquids which could reach the port from the outside, mostly accidentally, for example when cleaning the housing or when liquids are spilled by staff or the patient, by such liquids being drained downwards past the opening of the port be able .
- the port entrance or the second opening, is set back relative to the attachment section or its edge. The latter can also impede or prevent the entry of liquids from the outside.
- the second end opening of the second fluid guide of the port has a smaller cross-sectional area or opening area on the outside than a cross-sectional area or opening area of the second lumen, which is further inside the treatment device than the second end opening is arranged.
- the outer diameter of the first fluid guide is preferably constant, in particular in one Region in which the cross-sectional area or opening area of the second lumen increases axially, particularly towards the interior of the port or treatment device.
- Drops hanging between the opening and the inner wall advantageously tear off due to the distances selected inside the port between the opening and the inner wall.
- the cross-sectional area of the second lumen does not correspond to the cross-sectional area of the second opening, ie the opening of the second lumen to the outside.
- the user therefore has to exert less force (due to the comparatively small circumferential surface, which also forms the sealing surface) than if the second opening and thus also the rinsing cap had a diameter such as the second lumen has in the port.
- no section of an edge of the first fluid guide, which delimits the first opening is at a distance from an inner wall delimiting the second lumen which is not at least 7 mm.
- this distance corresponds additionally or alternatively to at least 1.1 times, 1.5 times or 2 times the difference between the radius of the outer peripheral surface of the first fluid guide and the radius of the inner peripheral surface of the second opening, ie e.g. B. where they are bounding side surfaces (z. B. in a longitudinal section, as shown in Fig. 1 or Fig. 2) parallel and / or at a constant angle to each other.
- the second opening is that portion of the second lumen or fluid conduit in which it has delimiting side surfaces (e.g., in a longitudinal section as shown in Figure 1 or Figure 2) parallel to one another are or stand .
- the second lumen of the second fluid guide of the port has at least one longitudinal section which is not delimited by side walls (i.e. e.g. upwards and downwards) which are parallel to one another and/or at a constant angle to one another stand .
- this longitudinal section is at least 3 mm long, preferably at least 5 mm long, particularly preferably at least 1 cm long. It is optionally located further outward (in relation to the housing of the treatment device or to the port) than the first opening. In this way, a distance is created between the inner wall of the second lumen and the first opening of the first fluid guide, which counteracts liquid transfer between the two during the treatment.
- the second lumen of the second fluid guide of the port has no longitudinal section in its longitudinal direction and/or no longitudinal section over at least 90% of its length and/or no longitudinal section with the exception of the section with the second opening, which in each case has at least 3 mm long, preferably at least 5 mm long, particularly preferably at least 1 cm long and optionally lies further outside than the first opening, which is or would be limited in a longitudinal section by side walls that are parallel and/or at a constant angle to one another.
- the second lumen of the port has a first cross-sectional area delimited by side walls of this lumen.
- This is preferably smaller than any other cross-sectional area delimited by the side walls of the second lumen, which faces further into the interior of the second lumen than the first cross-sectional area, i.e. lies further inside the port or in the treatment device than the first cross-sectional area.
- the second lumen widens, at least in sections, towards the interior of the port or the treatment device.
- the second lumen of the port has at least three cross-sections, each of which has a larger cross-sectional area toward the interior of the port or treatment device than the preceding one of these cross-sections.
- the second lumen of the port does not have a circular cross-sectional area in at least one cross-section.
- the first lumen of the port ends or opens in a funnel-shaped or diverging shape in the first end opening.
- the cross-sectional area of the first lumen is not arranged concentrically to the cross-sectional area of the second lumen in at least one cross-section of the port.
- the side walls of this cross-section that delimit the second lumen are non-uniform from a centerline of the first lumen, which is in longitudinally of the first lumen, spaced and/or the sections on the circumference of this cross-section are not all equally spaced from this center line.
- the second lumen has at least one cross-sectional area which has a smaller extension in its transverse direction than in its height.
- the second lumen of the port has at least one opening, e.g. B. a groove which is arranged on or in a side wall which delimits the second lumen and preferably extends in the circumferential direction of the second lumen or a section thereof.
- the opening preferably leads to an opening in the second lumen which, by means of a connection, serves or can serve to connect the second lumen to a drain or discharge line.
- the first opening at the end of the first fluid guide of the port faces further towards the interior of the port than the second opening at the end of the second fluid guide, ie it lies further inside.
- the first end opening of the first fluid guide is at least 5 mm, preferably at least 10 mm, more preferably at least 15 mm further in than the second end opening of the second fluid guide.
- the cross-sectional area of the second lumen of the port decreases from a cross-section in which the opening plane of the first end-side opening of the first lumen also lies, in the axial direction up to the start of the opening, e.g. B. up to the beginning of the groove , always and/or continuously to .
- the inner wall of the first lumen is formed so that it converges or widens towards the first opening, at least in sections. The angle can z. B. 2°.
- the wall or outer wall which surrounds the connector lumen is shaped to diverge or taper towards the opening of the connector lumen, at least in sections.
- the angle can z. B. 2°.
- the inner wall of the first lumen and the wall or outer wall surrounding the connector lumen are inclined at an identical amount of angle from the centerlines of their lumens.
- the first lumen is tapered only in the first third of the first fluid conduit or only in the first 1.5 mm to 3 mm.
- An opening angle of the first fluid guide can be between 10° and 20°, for example, preferably 15°.
- the length of the first fluid conduit, including the optional tapered portion is no more than 30 mm or no more than 35 mm.
- a radially outer boundary or outer wall of the first fluid guide is spaced from each radially inner surface of the side wall or inner wall of the second lumen over the entire free length of the first fluid guide, or at least in sections. This distance is at least 5 mm, preferably at least 8 mm. In this case, the free length can be that section of the first fluid guide which protrudes into the second lumen.
- the cross-sectional area of the first lumen of the port decreases from a cross-section in which the opening plane of the first opening of the first fluid guide also lies over a predetermined distance in the axial direction away from the first end-side opening of the first fluid guide always and/or continuously from . This predetermined distance is preferably at least 10 mm, particularly preferably at least 20 mm or at least 30 mm.
- an edge or a wall of the second end opening of the port has at least one fillet or a negative or concave fillet of a thickness or caliper of the edge or wall. They form defined entry points for air that flows in when the rinsing cap is opened, which closes this second end opening of the second lumen when the port is in use. If the groove is preferably provided on an upper edge section, the air flows there and thus at a point in the port at which, due to gravity, less residual liquid will have remained than in others, e.g. B. lower, areas .
- the port also has a leakage sensor, preferably a conductivity sensor.
- the leakage sensor preferably protrudes into the second lumen, i. H . it stands out from a side wall and ends freely.
- the leakage sensor is preferably a pin, pin, ring or tube or has a pin, pin, ring or tube.
- the leakage sensor carries or includes an insulating layer. It can prevent erroneous measurements due to residual moisture, particularly if it protrudes beyond a wall to which the leakage sensor is connected.
- the second lumen in particular an inner surface of the side wall or inner wall of the second lumen, has a depression in its lower area.
- the recess In a longitudinal section, in which the center line of the first fluid guide runs, the recess has a greater extension on the lower side than in at least two planes or all planes parallel thereto.
- the longitudinal section can be in the plane of the drawing in FIG. 1 or the fig. 2 correspond to or are parallel thereto.
- the second lumen and in particular an inner surface of the side wall or inner wall of the second lumen, has a depression in the lower region.
- this depression In at least one section which is not parallel to either a longitudinal section or a cross section through the second lumen, this depression has a section with a triangular or wedge-shaped shape. The tip of this shape is directed towards the inside of the port.
- this has a medical treatment device (im The following also briefly: treatment device), which in turn has a housing with a fastening section.
- the attachment section is used to connect the medical treatment device to a port, preferably the port as described herein, or vice versa.
- a port can be accommodated in the fastening section of the medical-technical treatment device, in particular a port as disclosed herein.
- the edge of the fastening section of the medical-technical treatment device runs annularly in a first section thereof with or under an inner radius, ie with a constant curvature.
- a second portion of the rim is not part of the inner radius annular shape formed by the first portion.
- the treatment device has a pivoting lever. This is arranged for its pivoting about a pivot axis, preferably running perpendicularly to the housing surface, with the pivot lever having a receiving section and/or a stop.
- the optional receiving section is provided for releasably receiving a rinsing cap, which is used to temporarily close the second lumen of the second fluid guide by or after pivoting the pivoting lever into a first pivoting position of the pivoting lever.
- the swiveling lever is rotated or swiveled until the flushing cap, which is in the receiving section is received, is in front of the second lumen of the second fluid guide.
- the optional receiving portion releasably includes a flush cap, particularly as described herein.
- the optional stop is intended to temporarily prevent an axial separating movement, which would lead to the connector of the disposable according to the invention being separated from the fastening section, ie z. B. pulling the connector out of the port.
- This axial separating movement is prevented by, or after, the pivoted lever has been pivoted into a second pivoted position of the pivoted lever. In the second pivot position z. B. arranged a stop of the pivoting lever in front of the connector.
- a sensor is provided and correspondingly connected to a signal, e.g. B. connected to the control device of the treatment device, which detects the handle position or predetermined positions that the handle occupies or can occupies.
- a successful, or an adequate, connection of the disposable in the port can thus be determined, monitored, etc., as well as optionally its disconnection.
- Alarms, indications, notifications, etc. can be provided by the signal coming from this sensor, as well as optional interventions in the control of the treatment device, which e.g. B. can be configured to block or interrupt predetermined treatment options or functions of the treatment device if the signal does not correspond to certain specifications or does correspond to it.
- the rinsing cap which is used to temporarily close the second end opening of the port, is detachable Recording section of the pivot lever taken on.
- the rinsing cap has an end face which faces the interior of the medical treatment device when the rinsing cap is in use and which has an axially and/or radially raised edge on its circumference.
- the flushing cap also has a first indentation or first groove running in or on its peripheral side.
- the rinsing cap also has a second indentation or second groove running in or on its peripheral side, which preferably adjoins the raised edge axially.
- the raised edge of the rinsing cap has a wedge-shaped or triangular section in a longitudinal section of the rinsing cap. This section can describe an isosceles triangle and/or run towards the point on both sides of the point at an angle of the same size. In certain embodiments, it can thus be ensured that less residual liquid remains in the port after the rinsing caps have been disconnected.
- the pivoting lever of the medical treatment device is arranged for pivoting about the pivot axis into a third pivoting position.
- neither the receiving section for releasably receiving a rinsing cap nor the stop for temporarily preventing an axial separating movement for separating the connector of the disposable is arranged in the axial direction in front of the second lumen of the port.
- the flushing cap has an outer rim that is preferably round or has a rounded rim portion with an outer radius that is between 90% and 99.9% of the inner radius of the first portion of the rim of the treatment device.
- the pivoting lever of the treatment device has an indentation or groove. It is designed for inserting a section of the edge of an end plate or disc of the connector.
- the recess is provided so that by pulling on the pivot lever, z. B. on a handle f f piece thereof, by means of the depression in which the edge of the terminal plate or disc is inserted, not only the swivel lever releases the port, but at the same time the connector is also pulled off the port.
- the port is incorporated into the fastening section of the treatment device in such a way that a center line of the first fluid guide or the first lumen is inclined 4° or more degrees to a placement surface of the medical treatment device.
- the system includes a displacement device, by means of which the pivoted lever of the treatment device can be displaced or guided in a translatory manner along the pivot axis.
- the displacement device can be part of the pivoting lever.
- the pivoting lever can only be displaced or guided to a limited extent or only by a predetermined distance by means of the displacement device. A limiting stop can be provided for this purpose.
- the shifting or guiding preferably takes place during use and/or without the use of tools.
- the port or treatment device includes a return element, such as a spring.
- the restoring element serves to move the receiving section in a translatory manner and/or to pretension the receiving section in the axial direction.
- the port or the treatment device has a damping device for damping a translational movement caused by the restoring element.
- the irrigation cap is sized such that the first indentation or groove and the second indentation or groove of the irrigation cap are in fluid communication with each other when the irrigation cap is inserted into the port. Fluids can thereby preferably flow in the axial direction on the outside of the rinsing cap along from the first groove or indentation into the second groove or indentation, or vice versa.
- the second groove or indentation results from the special design of the edge of the front surface of the flushing cap, as described in detail below.
- the connector has a rib structure on an outside thereof. This rib structure preferably extends to the connection opening, which is intended to be inserted at least in sections into the second lumen of the port when connecting the connector to the medical treatment device, or to the front end of the disposable or the connector.
- the rib structure has adjacent ribs which have or are located between them. limit arranged wells laterally.
- the connector has a disk structure.
- the disc structure is round or has a round rim portion with an outer radius that is between 90% and 99.9% of the inner radius of the first portion of the rim of the connector.
- the outer radius of the disk structure is at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm smaller than the inner radius of the first section.
- the outer edge section or the outer radius of the disk structure is at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm away from the first section of the edge.
- Ribs or another suitable surface structure can cause a non-gastight connection between the connector and the second opening receiving it. If the connector is pushed into the port, it will not push or pull any residual liquid that can adhere to the inner wall forming the second opening into the interior of the port. The ribs can rather such liquid residues, if necessary. also favored by capillary forces, absorb between them, which is why they can remain on the connector.
- such ribs can act as a ventilation option by allowing for rapid pressure equalization Inserting the connector into the port or pulling it out of the port.
- Ventilators can also conduct compressed air, which is blown into the port to clean or dry it, to the outside. This promotes air distribution inside the port and leads to complete or faster drying of residual liquid, which counteracts the spread of germs through liquid.
- the connector has a connector with a lumen through which a flow can flow.
- the mostly flexible fluid line is connected to the mostly rigid connector by means of this lumen, with the lumen of the connector through which flow can occur and the connector lumen being at an angle of between 80° and 100° to one another.
- the connector has a contact-protection sleeve with a free connection opening, with the connector lumen surrounded by a wall ending in an opening inside the contact-protection sleeve.
- the free connection opening and the opening in the wall preferably have a minimum distance of at least 10 mm from one another.
- the connector has a drip disc.
- the drip disc is arranged between the disc structure and the rib structure or between the disc structure and the protective cover.
- fluid guide in certain embodiments of the present invention, generally refers to a physical arrangement of elements capable of receiving and/or directing, guiding and the like are provided by fluids. Examples of this are tubes, hoses, channels, lines, chambers, fluid-guiding devices, etc.
- the first fluid guide is provided for discharging or Discharge of a medicinal fluid from an outlet opening of the first fluid guide (ie out of the port), e.g. B. into the environment, into an exterior, into the associated disposable, etc.
- the medical fluid is suitable and/or intended or intended for an extracorporeal blood treatment.
- the medicinal fluid is substitute fluid, in some embodiments of the present invention, substitute fluid produced on-line by a treatment device.
- a flushing cap refers to a closure device which is designed and/or provided to close or seal the port from an exterior of the port by closing or sealing its second opening of the second lumen . It can preferably be a closure cap.
- the rinsing cap can seal the port in a fluid-tight manner against the outside.
- the lumens of the port can be in fluid contact with an interior of the irrigation cap.
- the rinsing cap is intended to enable or promote cleaning of the port.
- the rinsing cap can be designed so that it can pivot and/or slide automatically or in an automated manner.
- the connector or its end section has, for example, PEEK (polyetheretherketone) or PEEK with PTFE
- the port has a hydrophilic coating at least in some sections or—in these sections—is made of a hydrophilic material.
- a hydrophilic coating of the port and/or the rinsing cap may be preferred in embodiments of the present invention.
- the port is part of a machine-side substitute system of the medical treatment device. In certain embodiments, the port on the medical treatment device is provided at an angle to the horizontal.
- the port can be attached at an angle of 8° ⁇ 3° to the horizontal.
- the port is arranged in such a way that in at least one position (rinsing position, connection position, etc.) its first lumen has an inclination to the horizontal as described above, with the free end of the first lumen being lower at this inclination than other sections hereof.
- Such an inclination can, in particular in combination with the optionally hydrophilic coating or the optionally hydrophilic material of the inner wall of the second lumen, promote non-tearing formation of a film of residual liquid moving in the direction of a connection for the drain or discharge line. This can be discharged from the port via the drain or waste line with almost no residue.
- the disclosed treatment device can be used as an extracorporeal treatment device, in particular as an extracorporeal blood treatment device, for example as a dialysis device, in particular as a hemodialysis device, hemofiltration device, hemodiafiltration device, or as a device for adsorption, liver replacement therapy, apheresis, transfusion, etc . designed .
- the treatment device has in certain
- Embodiments of the present invention have at least one device for introducing air into the second fluid guide.
- a "means for introducing air” as used herein includes, in certain embodiments of the invention, a system or an arrangement which is designed to introduce or introduce air into the second fluid guide, such as blowing in and/or suck in .
- the device for introducing air comprises means for generating sterile air or sterile compressed air from z.
- Ambient air such as at least one filter or sterile filter, a compressor and the like.
- the compressor can be prepared, and a control device of the treatment device can be prepared for a corresponding control or regulation in order to fill the port with compressed air before opening the flushing cap for emptying and thus to remove a large part of the liquid from the port in advance, preferably before opening the flushing cap.
- the device for introducing the sterile air can be provided at any point of the second fluid guide, but at a point different from the second opening or the free end of the second lumen.
- the port does not have a spring element, e.g. B. to be able to move the first fluid guide in an axial direction within the port against the spring force.
- the port has no screw section and/or no thread that would be provided to connect the disposable to the port.
- the outer diameter of the first fluid guide is constant, at least in a free area of the first fluid guide.
- the rib structure has ribs of at least or exactly two different lengths.
- some of the ribs of the rib structure extend to the connection opening or to the front end of the disposable or the connector, which end is inserted into the second lumen of the port when the connector is connected to the medical-technical treatment device, others however not.
- some or all of the ribs, in particular the rib structure have at least one non-rounded, sharp-edged or right-angled longitudinal boundary or edge in cross section, in particular in the transition to adjacent depressions, at least over a section of the rib in question.
- the longitudinal boundary or edge can z. B. have a radius of at most 0.1 mm, preferably at most 0.05 mm, which can result in the sharp-edgedness or which causes it.
- the connector has a drip disc and a disc structure.
- ribs are arranged between the draining disc and the disc structure, which are preferably at an angle extend between 75° and 105° to a flow-through lumen of the connector and/or are parallel to one another. They thus point away from a central axis of the lumen surrounding the rib structure at the angles specified here and/or are parallel to one another.
- the rib structure comprises at least 16 ribs distributed over the circumference of the contact protection sleeve, preferably at least 18, particularly preferably at least or exactly 20.
- the disposable has a closing plate or disk at the end which is not circular, e.g. B. end .
- the rim delimiting the first opening is spaced apart from the inner wall of the second lumen. At no point is this distance less than 5 mm, 6 mm, 7 mm or 8 mm.
- the port and disposable are designed in such a way that the wall, which surrounds the connector lumen that carries fluid when in use, is inserted at least in sections into the first lumen of the first fluid guide of the port when the port and disposable are plugged in or in use.
- the length of the contact protection sleeve is defined in such a way that the end face of the contact protection sleeve surrounding the connection opening protrudes through the inner wall of the second end opening or the opening adjoining it during insertion of the connector into the second lumen of the port second lumen is kept out of contact with the first Fluid guidance, especially not with the end-side opening and/or the end-side delimitation of the end-side opening, can come.
- the first end opening of the first fluid guide of the port faces further into the interior of the port than the second end opening of the second fluid guide.
- the length of the contact protection sleeve and/or the distance between the free connection opening and the opening of the connector lumen are set in such a way that the end face of the opening of the connector and/or the wall of the opening during insertion of the connector in the second lumen of the port cannot come into contact with the first fluid guide, in particular not with its end-side opening or front-side limitation.
- the system further includes a medical treatment device, which has a housing with an attachment portion for connecting the medical treatment device to the port, and/or the port, the attachment portion having an edge that optionally extends over adjacent Housing sections protrudes and / or in relation to these is raised.
- the medical-technical treatment device has a pivoting lever, arranged for its pivoting about a pivoting axis, the pivoting lever having a stop for temporarily preventing an axial separating movement for separating the connector of the disposable from the fastening section by or after pivoting of the pivoted lever into a second pivoted position of the pivoted lever.
- the stop is designed to limit rotation of the inserted connector about the longitudinal axis of its connector lumen, in particular in interaction with the end plate or disc of the disposable.
- some or all of the externally accessible sections or parts of the pivoting lever are dimensioned so large that they do not reach into the interior of the protective cover, or not up to the opening therein of the connector , protrude or can be pushed in .
- This geometric coordination of pivoted lever and contact protection sleeve with one another can advantageously help to prevent at least the connector from being accidentally touched by non-sterile sections of the pivoted lever.
- the outer edge section or the outer radius of the disc structure is at least 3 mm, preferably 4 mm, 4, 6 mm or more from the second section of the edge.
- the disk structure has a thickness of less than 1.5 mm, particularly preferably a maximum of 1 mm.
- less than 1.5 mm, particularly preferably a maximum of 1 mm, of the thickness or strength of the pane structure is or can be inserted into the edge.
- the disposable is part of a flexible fluid line, preferably also designed or provided as a disposable or disposable product, and/or connected thereto directly or indirectly.
- the connector can be plugged into z. B. a port is provided, wherein the connector may be protruding and/or provided to be grasped by hand for its insertion.
- all or some of the ribs of the rib structure, or their longitudinal extensions, run in a longitudinal direction of the connector or parallel to a flow direction of the connector.
- all or some of the ribs of the rib structure do not run in a circumferential direction of the connector.
- the disposable or its connector does not have or does not consist of a drip protection, which has or consists of concentric rings or grooves.
- the disposable is not part of a blood cassette and/or not part of a treatment device.
- the wall surrounding the connector lumen is spaced apart from an inner wall of the protective sleeve, preferably by at least 3 mm or more.
- the connector or the, or a, wall which surrounds the connector lumen is not movable or displaceable within the disposable, or in relation to this, is provided in the disposable or in the connector.
- the connector or the, or a, wall which surrounds the connector lumen is provided in a non-movable or displaceable manner within a treatment cassette, for example a blood treatment cassette.
- the pivoting lever is not intended to be rigidly connected to the flushing cap.
- the walls that delimit the first and/or the second lumen do not have spherical or differently shaped local thickenings, widenings or bulges of any kind.
- the present invention provides a port which can advantageously meet the highest hygiene requirements that are placed on medical treatment methods.
- an environment that is as germ-free as possible can advantageously be ensured at the connections between the disposable and the blood treatment device. This can help prevent germs from entering the patient's blood and thus increase patient safety. This is a consequence of the further reduction of residual liquids in the area of the second fluid guide of the port, which results in an initial emptying of the port
- a further advantage of the present invention can be that the transfer of germs to the patient by means of aerosols, which can occur due to dynamic negative and positive pressure conditions during fast movements during the connection and disconnection of disposable and rinsing cap, is reduced or prevented by means of the present invention will .
- Second fluid guidance advantageously prevents the formation of so-called “liquid bridges”. This also contributes to the reduction or avoidance of germ transfer into the bloodstream and thus to increased patient safety.
- the conductivity sensor can be used to detect microleakage inside the port during treatment.
- the port it can advantageously be possible to ensure sterility even in the humid environment in or on the connector, in which there is usually a risk of germs accumulating, and thus to minimize or completely rule out a risk of contamination for users and/or patients.
- An optional, hydrophilic coating of the port in particular in or at the end section of the same, can also advantageously contribute to preventing flying off to prevent liquid droplets when opening the connector.
- Another benefit can be in handling residual liquid in the port prior to disconnecting the disposable, which is collected and directed to the drain or waste line, resulting in port emptying optimization.
- Another advantage can be that when the disposable is inserted or the rinsing cap is on, there is a very narrow gap in the upper area of the port lumen closure, through which liquids on the surface of the device are drawn inwards by capillary forces and down there along the disposable or the rinsing cap to run . If the edge of the fastening section were circular, the liquid would collect in the lower area of the disposable or rinsing cap. Due to the larger gap between the machine front and disposable or However, the liquid can drain off the rinsing cap in the lower area and does not get into the interior of the port. A sealing closure to the front of the machine, which during connection and disconnection processes due to the pressure equalization for the drip or Aerosol formation can thus advantageously be avoided.
- FIG. 1 schematically shows a port of a system according to the invention for connecting a disposable according to the invention to a medical-technical treatment device of the system in fluid communication;
- FIG. 2 shows an enlarged detail of FIG. 1;
- FIG. 3 shows the port of FIG. 1 in a longitudinal section in a perspective view from the right;
- FIG. 4 shows a detail of the front or side view of a medical-technical treatment device with a view of a housing section thereof;
- Fig. 6 shows the connector of Fig. 5 in a partial sectional view
- Fig. 8 shows two ports each received in a mounting portion of a housing
- FIG. 9 shows a fluid line structure of a medical-technical treatment device in a schematically simplified manner.
- Fig. 1 shows a port 100 in a first embodiment of the system according to the invention.
- the port 100 has a first fluid guide 3 with at least one first lumen 31 and a first opening 32 at the end. Flow can flow through the first lumen 31 in its longitudinal direction, denoted by its center line M. Fluid present in the first lumen 31 can leave the first fluid guide 3 by means of the first end opening 32 .
- the port 100 also has a second fluid guide 5 with at least one second lumen 51 and a second opening 52 at the end.
- the second end opening 52 is shown in the embodiment of FIG. 1 as a transition from an exterior ⁇ of FIG. 1 only indicated medical treatment device 2000 to an interior I of the port 100 or the medical treatment device 2000 understood or referred to.
- the first fluid guide 3 lies in an interior of the second fluid guide 5 and, in relation to the port 100, its first opening 32 lies further in the interior I of the port 100 or the one shown in FIG. 1 only indicated medical treatment device 2000 (ie further inside) than the second opening 52 of the second fluid guide 5 .
- the second end opening 52 which can be an opening level, is provided in order to insert a section of a connector 4001 (see FIG. 5) of a disposable 4000 according to the invention into the interior of the port 100, with the aim of between the first fluid guide 3 and a connector lumen 4004, see FIG. 6 to establish a fluid connection .
- the second end opening should in this case preferably guide the connector 4001 in a stable position.
- the port 100 is intended to establish a fluid connection between at least one fluid line 2002 of the treatment device 2000 that is assigned or faces or is included in the interior I of a medical treatment device 2000, on the one hand, and a fluid line 4002 of the fluid-carrying disposable that is assigned to the connector 4001 of the exterior ⁇ of the treatment device 2000 4000 on the other hand.
- the connection preferably takes place in an end section 1 of the port 100 .
- Fig. 1 shows an attachment portion 2003 for attaching the port 100 to the port 100 shown in FIG. 1 only indicated medical treatment device 2000 .
- the port 100 leads in FIG. 1 by a housing section of a housing 2001 of the medical treatment device 2000 which is delimited by adjacent housing sections 2005 .
- Fig. 1 shows the port 100 in a state where it is not connected to a connector 4001 . It is closed with a flushing cap 200 . Fig. 1 thus shows the port 100 in a “flushing state” or “sealed state” of the port 100.
- the rinsing cap 200 which is placed on the port 100, closes the second end opening 52 and thus the interior of the port 100 and the two fluid guides 3, 5 against an exterior ⁇ of the port 100 and/or the medical treatment device.
- an outer edge 202 of the rinsing cap 200 is placed on or in the port 100 in a fluid-tight manner.
- An end face 205 of the rinsing cap faces the interior I.
- the flushing cap 200 can have a groove 204 on or at its peripheral side, which is explained in more detail below.
- the housing 2001 optionally has an edge 2007 that completely or at least partially surrounds the fastening section 2003 (see FIG. 4).
- the rim 2007 in turn has a first section 2007a and a second section 2007b, which are described in more detail with reference to FIG. 4 are discussed.
- At least one opening 54 can be provided on or in its side wall, which is shown in FIG. 1 lies in front of the plane of the drawing and is therefore not shown due to the section guide, in FIG. 3, on the other hand, already. Your function is with reference to the representation of FIG. 3 explained below .
- a leakage sensor 2031 is optionally provided in order to be informed at an early stage in the event of a leakage, for example from the fluid connection established between the fluid line 2002 of the treatment device 2000 on the one hand and the fluid line 4002 on the other.
- Appropriate voltage sources, lines, evaluation devices and alarm devices can be provided and suitably programmed where necessary.
- Fig. 1 also shows a receiving section 2015 as part of a pivoting lever, which is shown in FIG. 8 is denoted by reference number 2011 .
- a handle 2013 of the pivoting lever can also be seen. It is used by the user to pull the rinsing cap 200 out of the port 100 by pulling on the handle and in the axial direction (ie to the left in FIG. 1) and thus to end the rinsing position.
- the second lumen 51 of the second fluid guide 5 has at least one longitudinal section whose side walls (top and bottom in the sectional view in Fig. 1) are oriented in a direction along the center line M or parallel thereto (left-right in Fig. 1 ) are not parallel to each other and/or are not at a constant angle to each other. Rather, the cross-sectional area of the second lumen 51 increases constantly or even continuously over a certain distance to the right, as away from the second end opening 52 .
- the second lumen 51 optionally has a first cross-sectional area bounded by the sidewalls of the lumen 51 that is smaller than any other cross-sectional area of the second lumen 51 bounded by the sidewalls of the lumen 51, which further faces the interior I of the second lumen 51 than the first cross-sectional area, as can be seen further to the right in FIG. 1 from at least a region just before the first end-side opening 32 .
- the second lumen 51 widens at least in sections in the direction of the interior I.
- first lumen 31 can optionally terminate in a funnel or diverging shape in the first end opening 32 .
- compressed air source e.g. B. the medical technology
- Treatment device 2000 can be connected can be provided. It is preferably located at an end of the second lumen 51 opposite the second end opening 52, preferably on an upper side wall of the port 100.
- sterile air can be introduced via the sterile air supply line 47 and the cleaning or rinsing solution present in the port 100 can thus be largely removed.
- the cross-sectional area of the second lumen 51 increases in the axial direction up to the beginning of an opening of the port, which the second lumen has in at least one cross-section radially expanded and / or in which the opening of the sterile air supply line 47 is always and / or steadily.
- the edge which delimits the first opening 32 is at a distance from the inner wall of the second lumen 51 . At no point is this distance less than 5 mm, 6 mm, 7 mm or 8 mm. It can be seen that the distance is due to the widening of the second lumen 51 inwards, ie to the right. If this widening of the second lumen 51 did not exist, the distance between the edge and the inner wall of the second lumen 51 would be equal to the difference between the radius of the outer peripheral surface of the first fluid guide 3 and the radius of the inner peripheral surface of the second opening 52, in which the they limit Side surfaces are parallel and / or at a constant angle to each other, correspond.
- the step achieved or increased in this way serves to protect against a liquid bridge between liquid, which may have remained on the inner wall of the second lumen 51, and the first opening 31 of the first fluid guide 3 and thus ultimately serves to protect the patient from germs transferred in this way.
- Fig. 2 shows a section of Fig. 1 in enlargement.
- the second opening 52 may be located in or close off a longitudinal section (in the axial direction) in which the peripheral surfaces forming the second opening 52 are parallel to one another. Sections located further to the interior of the port 100 and adjoining the second opening 52 contribute to the above-mentioned Expansion of the second lumen 51 at.
- the circumferential, first groove 204 which is a z. B. can have a U-shaped, V-shaped or W-shaped profile, allows liquids that hit the rinsing cap 200 from the outside, mostly accidentally, for example when cleaning the housing or when liquids are spilled by staff or patients, to be discharged. down away.
- the flow path defined in this way leads such a liquid in a targeted manner away from the front area of the rinsing cap 200, through which it could sooner or later get into the interior of the port 100. Such a flow path is indicated by the arrows.
- the peripheral second groove 208 results from the special design of the front edge of the flushing cap 200 .
- FIG. 3 shows the port 100 of FIG. 1 in a perspective view from the right. 1 in a longitudinal section looking into the cut-out port 100 and the end face 205 of the flushing cap 200 and its edge 207.
- a reference cross-section QR is drawn - solely for reasons of reference.
- the second lumen 51 While there can be cross-sections of the second lumen 51 which have a circular cross-sectional area, as can be seen from the reference cross-section QRZU, the view in FIG. 3 but also that the second lumen 51 can have at least one cross-section which does not have a circular cross-sectional area.
- These include the cross sections shown in FIG. 3 are each to the right of the reference cross section QR, ie facing an interior I.
- the second lumen 51 optionally has at least one cross-sectional area which has a smaller extent in its transverse direction Q than in its height H perpendicular thereto, which can be seen in FIG. 3 extends in a top-bottom direction.
- Fig. 3 further shows that in at least one cross-section of the port 100, the cross-sectional area of the first lumen 31 is not concentric with the cross-sectional area of the second lumen 51 is arranged, which is already due to the fact that the second lumen 51 is itself not cylindrical in a region or cross-section in which it has the first fluid guide 3 or the first lumen 31 .
- Fig. 3 shows that the side walls of this cross section delimiting the second lumen 51 and/or its circumference do not have to be evenly spaced from a center line M of the first lumen 31, as is the case with the cross section in which the first end opening 32 is also located , or a cross-section lying further inwards, i.e. to the right, can be seen .
- the at least one, optional opening 54 of the port 100 already mentioned in relation to FIG. 1 expands the second lumen 51 radially in at least one cross section.
- the groove 54 runs along a lower part of the circumference of the second lumen 51, in others over the entire circumference, preferably over a part of the circumference lying below the first fluid guide in use, i.e. below the first in FIG fluid flow 3.
- the opening 54 preferably runs in a plane which is perpendicular to the center line M of the first lumen 31, which can also be advantageous for manufacturing reasons.
- the opening 54 is preferably located at that end of the second lumen 51 which is opposite the second end opening 52 thereof.
- the opening 54 can be connected via a line (not shown) to a drain or outflow line 153 ( FIG. 9 ), which can be in fluid connection to the lumen 51 via a connection 48 shown in FIG. 8 .
- the rim 207 can be designed to be as shown in FIG. 3 , in the inserted condition of the irrigation cap 200 and/or in the relaxed condition, not protrude less than 90° (or a range between 80° and 100°) from an axial centerline of the irrigation cap or axial centerline M of the port 100 .
- Fig. 4 shows a detail of the front or side view of a medical treatment device 2000 with a view of a housing section thereof, which has a fastening section 2003 for fastening a port, e.g. B. of port 200 .
- the fastening section 2003 serves to accommodate a port, which in turn serves to connect it to a disposable, in particular according to the invention.
- the attachment section 2003 serves in particular to accommodate the port 100, e.g. B. of the previous figures, in or on the housing 2001 of the medical treatment device 2000 .
- attachment portion 2003 is actually attached such a port.
- the port can be seen in Fig. 4 , however, not because it lies behind the plane of the drawing and is also covered by a connector 4001 , shown in cross section, of a disposable that is otherwise not shown.
- the connector lumen 4004 which is centrally located here by way of example, can be seen with a center point C, as well as the ones also shown in FIG. 5 and figs. 6 shown cover plate of a contact protection sleeve 4017 shown in the following figures.
- FIG. 4 The optional , to Fig . 1 already mentioned edge 2007, which delimits the fastening section 2003 from adjacent housing sections 2005 all the way round or only in sections and optionally protrudes beyond this in a direction out of the plane of the drawing, is shown in FIG. 4 to recognize .
- the edge 2007 has in Fig. 4 shows the first section 2007a by way of example, which has the course of part of a ring, with a center point C, which corresponds to the center of the connector lumen 4004 of the connector 4001, which is only shown in section in sections thereof.
- the second portion 2007b of the rim 2007 is not part of the ring shape about the center point C formed by the first portion 2007a.
- the second section 2007b delimits a dent or indentation 2009 of the fastening section 2003 , the base of which does not run parallel to the surface of adjacent housing sections 2005 , or does not do so to a large extent. Together with the first section 2007a, the second section 2007b forms the peripheral edge 2007, which is only optional. In the area of the dent or indentation 2009, the lower edge of the only optional peripheral edge 2007, ie the second section 2007b, is further away from the center C than the upper edge of the only optional peripheral edge 2007, ie the first section 2007a.
- a plurality of ribs 4003a and 4003b on its outer wall carries . Their radially outer dimensions allow the connector 4001 to be pushed into the second lumen 51 with the desired fit.
- the disk structure 4009 shown in FIG. 5 serves as an example of an optional flange for achieving a form fit in the radial direction with respect to the inner wall of the first section 2007a. It can thus cover the area circumscribed by the first section 2007a, but not the area circumscribed only by the second section 2007b.
- the disc structure 4009 can have an outer radius which is only slightly smaller than the inner radius of the first section 2007a.
- One or more grooves 52a which, starting from the inside of the second opening 52, mean a reduction in the wall thickness of the second fluid guide 5, are used for early air intake during the separating movement, through which the connector 4001 is separated from the port 200 by pulling on the connector 4001.
- Fig. 5 shows the connector 4001 of a disposable 4000 according to the invention which is only shown in sections and which additionally has a fluid line 4002 and a blood tubing set, a substitute line etc. can be or include .
- the connector 4001 is used to fluidly connect its in FIG. 6 to the first lumen 31 of the first fluid guide 3 of the port 100 ("connection state"). For this purpose, the connector 4001 is pushed at least in sections into the second lumen 51 of the port 100, as shown in FIGS. 4 and 7 recognize is where the one end connection opening 4019 of the connector 4001 is pushed over the first fluid guide 3 at least in sections thereof.
- the connector 4001 optionally has a rib structure 4003 on an outer side, which in the connection state described above is in radial contact with the inner wall of the second end opening 52 of the second fluid guide 5 .
- the rib structure 4003 has adjacent ribs 4003a, 4003b, between which there are depressions 4007a, 4007b, which due to the optional longitudinal course s of the ribs 4003a, 4003b in the axial direction laterally or. are limited in their transverse direction by the ribs 4003a, 4003b.
- the indentations 4007a, 4007b make up in a cross section of the connector 4001 (e.g. measured from the base of the ribs to the top of the ribs, i.e. in the radial direction), between 5% and 15%, preferably between 10% and 12% of the cross-sectional area of the connector 4001 in this cross-section.
- the cross-sectional area of the connector has z in this cross-section.
- the connector 4001 can have a disc structure 4009, which runs essentially perpendicularly to a longitudinal central axis of the connector 4001 (in a top-bottom direction in FIG. 5).
- the disc structure 4009 is preferably round or has a round edge portion with an outer radius.
- the outer radius is 90% to 99.9% of the inner radius of the first section 2007a of the edge 2007 .
- the outer radius of the disk structure 4009 is at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm smaller than the inner radius of the first section 2007a.
- the outer edge section or the outer radius of the disc structure 4009 has a distance of at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm from the first section 2007a of the edge 2007 .
- the connector 4001 has a connector 4015 with a lumen through which fluid can flow, by means of which the fluid line 4002 of the disposable 4000 according to the invention is or can be connected to the connector 4001 .
- the flow-through lumen of the connector 4015 and the connector lumen 4004, or their center lines are at an angle of between 80° and 100° to one another, for example.
- the connector 4001 has a contact protection sleeve 4017 ending with the free or end connection opening 4019 .
- the connector lumen 4004 surrounded by a wall 4021 , opens into an opening 4023 inside the contact protection sleeve 4017 .
- the free connection opening 4019 and the opening 4023 of the wall 4021 are preferably spaced apart by a minimum distance of at least 10 mm, preferably at least 14 mm.
- the connector 4001 can have an end plate or disc 4027 . It can be arranged perpendicular to the center line of the connector lumen 4004 . It can protrude radially on its circumference or along its entire circumference over structures adjoining it or over all structures adjoining it.
- the final plate or disk 4027 can be used to be partially received by means of a groove of the pivoting lever 2011 with a corresponding pivoting of the pivoting lever 2011 . This can result in the connector 4001 being pulled out when the handle 2013 of the pivoted lever 4011 is pulled out, see FIG. 8 , facilitate .
- Fig. 6 shows connector 4001 of FIG. 5 in a partial sectional view.
- Fig. 7 shows the connection status between port 100 and connector 4001 in a simplified longitudinal section, in which the connector lumen 4004 is not shown.
- Ports 100 but flows further out already at the Disk structure 4009 down from .
- the same advantageous effect can be achieved with a suitably selected geometry for the port and rinsing cap.
- Fig. 8 shows two ports 100 each received in a mounting portion of a housing 2001 .
- a pivoting lever 2011 which is arranged to be rotatable or pivotable about its own pivot axis S, is provided for each of the two ports 100 .
- a connector 4001 of a disposable according to the invention (not shown in detail) is pushed into the port 100 shown at the top left.
- the associated pivoting lever 2011 is pulled so far out of the housing 2001 that between a rear side of a stop 2017 of the pivoting lever 2011 and the port 100 there is space for the connector 4001, to the extent that it should protrude from the port 100.
- the stop 2017 serves to protect against the connector 4001 being unintentionally pulled out of the associated port 100 in the direction along the pivot axis S or parallel to this . It prevents the connector 4001 from moving outwards ⁇ and/or parallel to the pivot axis S .
- a restoring element 2041 can exert pressure on the connector 4001 in the direction of the port 200 by means of the stop 4017 and thereby prevent it from slipping out.
- the pivoting lever 2011 can be pulled out by a few centimeters by means of the gripping section 2013 along the pivoting axis S from the housing 2001 and, after this pulling out, for example counterclockwise, rotated or pivoted.
- the pivoting can cause a release of the connector 4001 by the stop 2017 , which is also turned away about the pivot axis S , releases the way by means of the pivoting movement in order to be pulled out of the port 100 .
- the second opening 52 of the port 100 that is now exposed can be closed by means of the rinsing cap 200 .
- the pivoting lever 2011 is turned clockwise until the flushing cap 200 received in the receiving section 2015 is in front of the second opening 52 .
- the optional restoring element 2041 pulls the pivoting lever 2011 and thus the rinsing cap 200 detachably connected to it toward the second opening 52 .
- the movement ends when the flushing cap 200 is firmly seated in or on the second opening 52 .
- a damping element can be provided which has a damping effect on the application of force by the restoring element 2041 .
- the pivoting lever 2011 has a depression or groove for inserting or receiving a section of the edge of a closing plate or disk 4027 at the end of the connector 4001 . If the swivel lever 2011 is pulled, e .g . B. in order to swivel it from a connection position, in which the port 100 is connected to the disposable 4000 according to the invention, into another swivel position, the connector 4001 can already be pulled out of the port 100 in a controlled manner by means of this movement.
- Fig. 9 shows a process diagram of a medical treatment device 2000 described herein, here a blood treatment device, connected to a extracorporeal blood circuit 300, which leads to treatment by means of double-needle access, or using z.
- the blood circuit 300 can optionally be present in portions thereof in or on a blood cassette.
- Pumps, actuators and/or valves in the area of the blood circuit 300 are connected to the treatment device 2000 or with one of these z. B. included control device 150 connected.
- the blood circuit 300 comprises (or is connected to) an arterial patient tube clamp 302 and an arterial connection needle of an arterial segment or an arterial patient line, blood sampling line or first line 301 .
- the blood circuit 300 further includes (or is connected to) a venous patient tubing clamp 306 and a venous connection needle of a venous section , venous patient line, blood return line or second line 305 .
- a blood pump 101 is provided in or on the first line 301, a substituate pump 111 is connected to a dialysis fluid supply line 104 for conveying fresh dialysis fluid, which is filtered in a further filter stage (F2) (substituate).
- a substituate line 105 may be fluidly connected to the feed line 104 .
- substituate can be added by pre-dilution, via a pre-dilution valve 107, or by post-dilution, via a post-dilution valve 109, via associated lines 107a or 109a into line sections, for example in the arterial line section 301 or into the venous line section 305 (here between a blood chamber 303b of a blood filter 303 and a venous air separation chamber or venous blood chamber 329) of the blood circuit 300.
- the blood filter 303 has the blood chamber 303 b connected to the arterial line section 301 and to the venous line section 305 .
- a dialysis fluid chamber 303a of the blood filter 303 is connected to the dialysis fluid supply line 104 leading to the dialysis fluid chamber 303a and one leading away from the dialysis fluid chamber 303a
- Dialysate drain line 102 which conducts dialysate, ie used dialysis fluid, is connected.
- Dialysis fluid chamber 303a and blood chamber 303b are separated from one another by a mostly semi-permeable membrane 303c. It represents the separating sheath between the blood side with the extracorporeal blood circuit 300 and the machine side with the dialysis liquid or
- Dialysate circuit which is shown in FIG. 9 is shown to the left of membrane 303c.
- the arrangement of FIG. 9 includes an optional detector 315 for detecting air and/or blood.
- the arrangement of FIG. 9 also includes one or two pressure sensors PS I (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101, it measures the pressure upstream of the blood filter 303 (“pre-hemof ilter”)) at the locations shown in FIG.
- Additional pressure sensors can be provided, e.g. B. the pressure sensor PS3 downstream of the bladder venous chamber 329 .
- An optional single-needle chamber 317 is shown in FIG. 9 as a buffer and/or expansion tank in a single-needle Method for use in which the patient is connected to the extracorporeal blood circuit 300 by means of only one of the two blood lines 301, 305.
- the arrangement of Figure 9 also includes an optional detector 319 for detecting air bubbles and/or blood.
- An addition point 325 for heparin can optionally be provided.
- a mixing device 163 is shown on the left in FIG. 9, which from the containers A (for A concentrate via the concentrate supply 166) and B (for B concentrate via the concentrate supply 168) produces a predetermined mixture for the respective solution for use by the treatment device 2000 provides .
- the solution contains, in z. B. the heater 16 heated water (online, e.g. as reverse osmosis water or from bags) from the water source 155.
- a pump 171 which may be referred to as a concentrate pump or sodium pump, is fluidly connected to and/or pumps from the mixing device 163 and a source of sodium, such as container B.
- the optional compressor referred to herein is referenced 175 and communicates with port 100.
- a drain 153 for the effluent can also be seen in FIG. 9 .
- An optional heat exchanger 157 and a first flow pump 159 suitable for degassing complete the arrangement shown.
- Yet another pressure sensor can be provided as PS4 downstream of the blood filter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate outflow line 102 to measure the filtrate pressure or membrane pressure of the blood filter 303 .
- optional pressure measuring points P can also be provided.
- Blood leaving the blood filter 303 flows through an optional venous blood chamber 329 which may have a vent 318 and be in fluid communication with the pressure sensor PS3.
- the ones shown in Fig. The exemplary arrangement shown in FIG. 9 has the control or regulating device 150 . It can be in a wired or wireless signal connection with each of the components mentioned here--in any case or in particular with the blood pump 101--in order to control or regulate the treatment device 2000.
- the sodium content of the dialysis fluid can be varied within certain limits by means of the device for online mixing, controlled by the control device 150 .
- the measured values determined by means of conductivity sensors 163a, 163b can be included. If an adjustment of the sodium content of the dialysis fluid (sodium concentration) or of the substitute is necessary or desired, this can be done by adjusting the delivery rate of the sodium pump 171 .
- the treatment device 2000 includes means for conveying fresh dialysis fluid and dialysate.
- a first valve can be provided between the first flow pump 159 and the blood filter 303, which opens or closes the inlet to the blood filter 303 on the inlet side. closes .
- a second, optional flow pump 169 is e.g. B. provided downstream of the blood filter 303, which promotes dialysate to the drain 153.
- a second valve can be provided between the blood filter 303 and the second flow pump 169, which opens or closes the outlet on the outlet side. closes .
- the treatment device 2000 optionally includes a device 161 for balancing the flow flowing into and out of the dialyzer 303 on the machine side.
- the device 161 for balancing is preferably arranged in a line area between the first flow pump 159 and the second flow pump 169 .
- the treatment device 2000 also includes means for the exact removal of a volume of liquid specified by the user and/or by the control device 150 from the balanced circuit, such as the ultrafiltration pump 131 .
- Sensors such as the optional conductivity sensors 163a, 163b serve to determine the conductivity, which is temperature-compensated in some embodiments, and the liquid flow upstream and downstream of the dialyzer 303 .
- Temperature sensors 165a, 165b can be provided individually or in groups. According to the invention, temperature values supplied by them can be used to determine a temperature-compensated conductivity.
- a leakage sensor 167 is optionally provided. It can be provided on or in the port 100 .
- Other flow pumps in addition or as an alternative to e.g. B. those with reference number 169 can also be provided.
- FIG. 9 A number of optional valves are shown in Fig. 9 each marked with V .
- Bypass valves are denoted by VB.
- control device 150 determines the electrolyte and/or liquid balance based on the measured values of the aforementioned, optional sensors.
- Filters F1 and F2 can be connected in series.
- the filter Fl is used here, for example, to produce sufficiently pure dialysis liquid by means of the mixing device 163 itself using impure water, which then, e.g. B. in the countercurrent principle, flows through the blood filter 303 .
- the filter F2 is used here, for example, to remove z. B. to generate pyrogenic substances fen sterile or sufficiently filtered substituate, which can safely be supplied to the extracorporeally flowing blood of the patient and thus ultimately to the patient's body.
- the treatment device 2000 is shown in FIG. 9 is optionally shown as a device for hemo(dia)filtration.
- hemodialysis devices also fall within the scope of the present invention, although not specifically shown in the figure.
- a possible position of the port 100 within the treatment device 2000 can be seen.
- the present invention is not limited to the embodiment described above, which is for illustrative purposes only.
- arrowheads shown in Fig. 9 generally indicate the flow direction in each case.
- Predilution valve a line belonging to the predilution valve
- Postdilution valve a line belonging to the postdilution valve
- PSI arterial pressure sensor (optional)
- PS2 arterial pressure sensor (optional)
Landscapes
- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Urology & Nephrology (AREA)
- Emergency Medicine (AREA)
- Cardiology (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- External Artificial Organs (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
BR112023006223A BR112023006223A2 (pt) | 2020-10-07 | 2021-10-06 | Dispositivo descartável e sistema com um orifício |
CA3194736A CA3194736A1 (en) | 2020-10-07 | 2021-10-06 | Disposable and system with a port |
US18/030,637 US20230364408A1 (en) | 2020-10-07 | 2021-10-06 | Disposable and system with a port |
AU2021357734A AU2021357734A1 (en) | 2020-10-07 | 2021-10-06 | Disposable and system having a port |
MX2023003860A MX2023003860A (es) | 2020-10-07 | 2021-10-06 | Desechable y sistema con puerto. |
CN202180069167.1A CN116322822A (zh) | 2020-10-07 | 2021-10-06 | 一次性用品和具有端口的系统 |
EP21789666.1A EP4225393A1 (de) | 2020-10-07 | 2021-10-06 | Disposable und system mit einem port |
KR1020237015456A KR20230083332A (ko) | 2020-10-07 | 2021-10-06 | 일회용 부분 및 포트를 갖는 시스템 |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102020126225.6 | 2020-10-07 | ||
DE102020126226.4A DE102020126226A1 (de) | 2020-10-07 | 2020-10-07 | Disposable und System mit einem Port |
DE102020126226.4 | 2020-10-07 | ||
DE102020126225 | 2020-10-07 | ||
DE102021103496.5A DE102021103496A1 (de) | 2021-02-15 | 2021-02-15 | Medizintechnische Behandlungsvorrichtung mit Überdruck im Port |
DE102021103496.5 | 2021-02-15 |
Publications (2)
Publication Number | Publication Date |
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WO2022074049A1 true WO2022074049A1 (de) | 2022-04-14 |
WO2022074049A9 WO2022074049A9 (de) | 2022-06-16 |
Family
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PCT/EP2021/077517 WO2022074039A1 (de) | 2020-10-07 | 2021-10-06 | Medizintechnische behandlungsvorrichtung mit überdruck im port |
PCT/EP2021/077538 WO2022074048A2 (de) | 2020-10-07 | 2021-10-06 | Port, spülkappe, medizintechnische behandlungsvorrichtung, sowie system |
PCT/EP2021/077539 WO2022074049A1 (de) | 2020-10-07 | 2021-10-06 | Disposable und system mit einem port |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
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PCT/EP2021/077517 WO2022074039A1 (de) | 2020-10-07 | 2021-10-06 | Medizintechnische behandlungsvorrichtung mit überdruck im port |
PCT/EP2021/077538 WO2022074048A2 (de) | 2020-10-07 | 2021-10-06 | Port, spülkappe, medizintechnische behandlungsvorrichtung, sowie system |
Country Status (11)
Country | Link |
---|---|
US (4) | US20230405296A1 (de) |
EP (3) | EP4225393A1 (de) |
JP (2) | JP2023544806A (de) |
KR (2) | KR20230083331A (de) |
CN (3) | CN116322822A (de) |
AU (1) | AU2021357734A1 (de) |
BR (1) | BR112023006223A2 (de) |
CA (2) | CA3195545A1 (de) |
MX (1) | MX2023003860A (de) |
TW (1) | TW202220714A (de) |
WO (3) | WO2022074039A1 (de) |
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US20090261581A1 (en) * | 2003-11-10 | 2009-10-22 | Fresenius Medical Care Deutschland Gmbh | Connector for dialysis port |
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EP2595691A2 (de) * | 2010-07-23 | 2013-05-29 | Fresenius Medical Care Deutschland GmbH | Konnektor, medizintechnische behandlungsvorrichtung, medizintechnische funktionseinrichtung sowie verfahren |
US20150025437A1 (en) * | 2013-07-18 | 2015-01-22 | Cryolife, Inc. | Vascular access system with connector |
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IT1394269B1 (it) * | 2009-06-16 | 2012-06-06 | Grandolfo | Dispositivo terminale per catetere permanente per emodialisi |
CH707315A1 (de) * | 2012-12-07 | 2014-06-13 | Medela Holding Ag | Absaugvorrichtung mit spülbarer Drainageleitung. |
EP3148608B1 (de) * | 2014-05-27 | 2019-01-09 | DEKA Products Limited Partnership | Systeme zum erkennen von gefässzugangstrennung |
-
2021
- 2021-10-04 TW TW110136847A patent/TW202220714A/zh unknown
- 2021-10-06 EP EP21789666.1A patent/EP4225393A1/de active Pending
- 2021-10-06 JP JP2023521388A patent/JP2023544806A/ja active Pending
- 2021-10-06 JP JP2023521390A patent/JP2023545745A/ja active Pending
- 2021-10-06 KR KR1020237015455A patent/KR20230083331A/ko unknown
- 2021-10-06 US US18/030,645 patent/US20230405296A1/en active Pending
- 2021-10-06 AU AU2021357734A patent/AU2021357734A1/en active Pending
- 2021-10-06 WO PCT/EP2021/077517 patent/WO2022074039A1/de unknown
- 2021-10-06 BR BR112023006223A patent/BR112023006223A2/pt unknown
- 2021-10-06 CA CA3195545A patent/CA3195545A1/en active Pending
- 2021-10-06 US US18/030,637 patent/US20230364408A1/en active Pending
- 2021-10-06 MX MX2023003860A patent/MX2023003860A/es unknown
- 2021-10-06 EP EP21789665.3A patent/EP4225392A2/de active Pending
- 2021-10-06 WO PCT/EP2021/077538 patent/WO2022074048A2/de unknown
- 2021-10-06 CN CN202180069167.1A patent/CN116322822A/zh active Pending
- 2021-10-06 CN CN202180069034.4A patent/CN116322820A/zh active Pending
- 2021-10-06 US US18/030,666 patent/US20230398273A1/en active Pending
- 2021-10-06 US US17/495,254 patent/US20220105335A1/en active Pending
- 2021-10-06 WO PCT/EP2021/077539 patent/WO2022074049A1/de unknown
- 2021-10-06 CN CN202180069142.1A patent/CN116322821A/zh active Pending
- 2021-10-06 KR KR1020237015456A patent/KR20230083332A/ko unknown
- 2021-10-06 EP EP21790803.7A patent/EP4225394A1/de active Pending
- 2021-10-06 CA CA3194736A patent/CA3194736A1/en active Pending
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US20050283132A1 (en) * | 2002-10-22 | 2005-12-22 | Stanus J B P | Access port with safety tab and fluid container employing same |
US20090261581A1 (en) * | 2003-11-10 | 2009-10-22 | Fresenius Medical Care Deutschland Gmbh | Connector for dialysis port |
US20100270792A1 (en) * | 2009-04-23 | 2010-10-28 | Fresenius Medical Care Deutschland Gmbh | Connection means and method for connecting at least two fluid-conducting medical-technical systems, as well as medical-technical apparatus |
EP2595691A2 (de) * | 2010-07-23 | 2013-05-29 | Fresenius Medical Care Deutschland GmbH | Konnektor, medizintechnische behandlungsvorrichtung, medizintechnische funktionseinrichtung sowie verfahren |
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Also Published As
Publication number | Publication date |
---|---|
KR20230083332A (ko) | 2023-06-09 |
TW202220714A (zh) | 2022-06-01 |
EP4225393A1 (de) | 2023-08-16 |
CN116322822A (zh) | 2023-06-23 |
CN116322821A (zh) | 2023-06-23 |
WO2022074048A2 (de) | 2022-04-14 |
KR20230083331A (ko) | 2023-06-09 |
WO2022074039A1 (de) | 2022-04-14 |
WO2022074049A9 (de) | 2022-06-16 |
BR112023006223A2 (pt) | 2023-05-09 |
US20230364408A1 (en) | 2023-11-16 |
CN116322820A (zh) | 2023-06-23 |
US20230398273A1 (en) | 2023-12-14 |
MX2023003860A (es) | 2023-04-14 |
CA3194736A1 (en) | 2022-04-14 |
US20220105335A1 (en) | 2022-04-07 |
AU2021357734A1 (en) | 2023-06-01 |
WO2022074048A3 (de) | 2022-08-04 |
EP4225394A1 (de) | 2023-08-16 |
US20230405296A1 (en) | 2023-12-21 |
EP4225392A2 (de) | 2023-08-16 |
JP2023545745A (ja) | 2023-10-31 |
CA3195545A1 (en) | 2022-04-14 |
JP2023544806A (ja) | 2023-10-25 |
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