Port, flush cap, medical treatment device, and system
The dual fluid guide port and rinse cap mechanism with sterile air introduction address sterility and contamination issues in medical treatment devices, ensuring a safe and hygienic fluid connection by minimizing residual fluids and aerosol formation.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2025-11-05
- Publication Date
- 2026-03-04
AI Technical Summary
Existing medical treatment devices face challenges in maintaining sterility and preventing bacterial contamination at fluid connections between disposable items and the device, particularly due to residual fluids and aerosol formation during connection and disconnection processes.
A port design with a dual fluid guide system, including a first fluid guide within a second fluid guide, and a rinse cap mechanism that introduces sterile air to evacuate residual liquids before disconnection, combined with a swivel lever and leak sensor to ensure sterility and minimize fluid contact.
The solution enhances patient safety by reducing bacterial transfer and aerosol formation, maintaining a sterile environment, and effectively managing residual fluids, thereby improving hygiene and reducing contamination risks.
Smart Images

Figure 2026035615000001_ABST
Abstract
Description
[Technical Field]
[0001] The present invention relates to a port as claimed in claim 1. The present invention also relates to a rinse cap as disclosed herein, a medical treatment device as claimed in claim 10, and a system as claimed in claim 18. [Background technology]
[0002] Medical treatment devices typically have one or more ports. Lines are connected to them to guide fluids from the interior of the medical treatment device, and vice versa. If the lines are for single use, they are called disposable. Summary of the Invention
[0003] It is an object of the present invention to specify a further port suitable for this purpose. A rinse cap is also disclosed. Furthermore, a further medical treatment device and a further system are specified.
[0004] The object according to the invention is achieved by a port having the features of claim 1 and also by the rinse cap disclosed herein, which is also part of the invention and can therefore be claimed. The object according to the invention is also achieved by a medical treatment device having the features of claim 10 and by a system having the features of claim 18.
[0005] According to the present invention, a port is proposed herein that serves to establish a fluid connection between at least one fluid line of the medical treatment device, which is allocated to, faces the interior of, or is exclusively internal to the medical treatment device, and a connector of a fluid line of a disposable item through which the fluid is conducted during use. The fluid line is not part of the medical treatment device, but rather is allocated to, faces the exterior of, or is exclusively external to the medical treatment device. The fluid line of the disposable item can be, for example, a tubing set or part thereof, or a substitution fluid line, etc.
[0006] The port typically includes a first fluid guide at its end portion, which is or includes a first lumen and a first end opening or face through which fluid can flow longitudinally. The fluid guide is provided for receiving and / or guiding medical fluid and for establishing a fluid connection with the connector.
[0007] The port also includes a second fluid guide disposed further outward (relative to the port) than the first fluid guide, the second fluid guide including at least a second lumen and a second end opening or opening surface, such that the first fluid guide is further inward from the port than the second fluid guide, and the first end opening is further inward from the port than the second end opening.
[0008] Here, the first end opening of the first fluid guide is at least partially disposed within the second lumen of the second fluid guide.
[0009] According to the present invention, a medical treatment device (hereinafter also referred to as treatment device for short) is proposed, which comprises a housing having a fastening portion, which serves to connect the medical treatment device to a port, preferably a port according to the present invention, and vice versa.
[0010] Optionally, ports, particularly ports according to the present invention, may be received in a fastening portion of a medical treatment device.
[0011] The system of the present invention comprises a medical treatment device of the present invention and a disposable item, the disposable item comprising a fluid line and a connector, the connector having a connector lumen, preferably inside the port, for fluidly connecting the fluid line with the first lumen of the first fluid guide.
[0012] The present invention also relates to a plug-in system having a component, such as a port as described herein, and a component inserted therein, such as a connector as described herein.
[0013] The receiver comprises an edge, preferably a raised edge, which is annular at a first portion with an inner radius, and a second portion of the edge is not part of the annular shape with the inner radius formed by the first portion.
[0014] The part to be received preferably comprises a disk structure with a rounded or rounded edge portion, which corresponds to a value of 90% to 99.9% of the inner radius of the receiving part and / or has an outer radius which is at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm smaller than the inner radius of the first portion, and / or the outer edge portion or outer radius of the disk structure is spaced or separated from the first portion of the edge by at most 1 mm, preferably at most 0.5 mm, particularly preferably 0.1 mm.
[0015] The present invention further relates to a method for disconnecting or separating a rinse cap from a port, or preparing for such disconnection or separation, which can be performed or carried out by the device disclosed herein. The method comprises providing a system according to the present invention, wherein the rinse cap is inserted onto or into the port. The method further comprises introducing air or sterile air into the port by a compressor before separating the rinse cap. The introduction can be initiated automatically by a control device of the treatment device, and corresponding control or regulation can be provided. The purpose of the introduction can be to introduce compressed air into the port to empty it of liquid, thereby removing a large portion of the liquid still present in the port by displacing it with the compressed air before the rinse cap is separated. The method can also include separating the rinse cap from the port. The separation can be performed by using and moving a swivel lever disclosed herein.
[0016] Embodiments according to the invention may comprise any combination of some, several or all of the features described below, unless a person skilled in the art recognizes that a particular combination is technically impossible, and advantageous developments of the invention are the subject of the respective dependent claims.
[0017] In all of the above and below, the use of expressions such as "may be" or "may have" should be understood as synonymous with "preferably is" or "preferably has", respectively, and is intended to exemplify embodiments according to the present invention.
[0018] Whenever numerical terms are used herein, those skilled in the art will recognize or understand them as indicating a lower numerical limit. Unless this would lead the skilled artisan to an obvious contradiction, those skilled in the art will understand, for example, a designation of "one" to encompass "at least one." This understanding is also equally encompassed by the present invention, as is the interpretation that a numerical term, for example, "one," may alternatively mean "exactly one," whenever this is clearly technically possible for those skilled in the art. Both understandings are encompassed by the present invention and apply to all numerical terms used herein.
[0019] Whenever spatial references such as "top," "bottom," "upper," or "lower" are mentioned in this specification, those skilled in the art will, in case of doubt, understand this as spatial information relating to the orientation in the accompanying drawings and / or placement of the ports of the present invention in their intended use.
[0020] Whenever an embodiment is described herein, it is an exemplary embodiment according to the present invention and should not be understood as limiting.
[0021] When the subject matter of the present invention is disclosed herein as comprising one or several features in a particular embodiment, e.g., by way of a disclaimer, it is also hereby disclosed that the subject matter of the present invention does not explicitly comprise one or several of the features in other embodiments of the present invention as well. Therefore, for every embodiment described herein, it also applies that the opposite embodiment, e.g., formulated as a negation, is also disclosed.
[0022] The plug-in system of the present invention may be further developed in embodiments using any of the features disclosed herein in any combination.
[0023] In some embodiments, the fastening portion preferably comprises a raised edge that may protrude above, be recessed relative to, or be flush with an adjacent housing portion. Additionally or alternatively, the second opening is optionally recessed relative to the edge or adjacent housing portion. This can prevent the ingress of liquids that may reach the port from outside, most accidentally, for example, when cleaning the housing or when personnel or patients spill liquids, by allowing such liquids to drain downward past the port opening.
[0024] In some embodiments, the port inlet or second opening is recessed relative to the fastening portion or its edge, again to impede or prevent the ingress of external liquids.
[0025] In some embodiments of the port according to the present invention, the second end opening of the second fluid guide has a smaller cross-sectional area or opening area on the outside than the cross-sectional area or opening area of the second lumen located further inside the treatment device than the second end opening. Here, the outer diameter of the first fluid guide is preferably constant, especially in the region where the cross-sectional area or opening area of the second lumen increases axially, especially toward the interior of the port or treatment device. In this way, on the one hand, a sufficiently large distance is formed between the first opening of the first fluid guide and the inner wall of the second lumen, which, due to the sufficiently large distance formed between the two, prevents the formation of a liquid bridge between the opening and the inner wall. Liquid droplets that drip between the opening and the inner wall are advantageously broken off due to the selected distance inside the port between the opening and the inner wall. On the other hand, the cross-sectional area of the second lumen does not correspond to the cross-sectional area of the second opening, i.e., the opening of the second lumen toward the outside. Therefore, when opening the rinse cap, the user needs to apply less force (due to the relatively smaller circumferential area that also forms the sealing surface) than if the second opening, and therefore the rinse cap, had a diameter similar to that of a second lumen further inside the port.
[0026] In some embodiments, no part of the edge of the first fluid guide that defines the first opening is more than at least 7 mm from the interior wall that defines the second lumen.
[0027] In some embodiments, this distance additionally or alternatively corresponds to at least 1.1, 1.5, 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, e.g., the sides defining said second opening (e.g., in the longitudinal cross section shown in Figure 1 or Figure 2) are parallel to each other and / or form a fixed angle with each other.
[0028] In some embodiments, the second opening is a region of a second lumen or second fluid guide, and the sides defining the second opening (e.g., in the longitudinal cross section shown in Figure 1 or Figure 2) are parallel or lie parallel to one another.
[0029] In some embodiments, the second lumen of the second fluid guide comprises at least one longitudinal portion that is not bounded by sidewalls (i.e., upper and lower, for example) that are parallel to each other and / or at a fixed angle to each other. In some embodiments, this longitudinal portion is at least 3 mm long, preferably at least 5 mm long, and particularly preferably at least 1 cm long. It is optionally located further outward (relative to the housing or port of the treatment device) than the first opening. In this way, a distance is formed between the inner wall of the second lumen and the first opening of the first fluid guide, which distance opposes fluid movement between the two during treatment.
[0030] In some embodiments, the second lumen of the second fluid guide of the port has no longitudinal portion in its longitudinal direction and / or no longitudinal portion over at least 90% of its length and / or has a length of at least 3 mm, preferably at least 5 mm, particularly preferably at least 1 cm, excluding the portion having the second opening, and optionally no longitudinal portion extending further outside the first opening that is or would be limited in longitudinal cross section by side walls that are parallel to each other and / or at an angle to each other.
[0031] In some embodiments of the port, the second lumen comprises a first cross-sectional area defined by a sidewall of the lumen that is preferably smaller than any other cross-sectional area defined by a sidewall of the second lumen that faces further toward the interior of the second lumen than the first cross-sectional area, i.e., that is further inward of the port or treatment device than the first cross-sectional area.
[0032] In some embodiments of the port, the second lumen flares at least partially toward the interior of the port or treatment device.
[0033] In some embodiments, the second lumen comprises at least three cross sections, each of which comprises a larger cross-sectional area than each preceding cross section in the direction toward the interior of the port or treatment device.
[0034] In some embodiments, the second lumen does not comprise a circular cross-sectional area in at least one cross section.
[0035] In some embodiments of ports according to the present invention, the first lumen terminates or opens in a funnel or diverging shape at the first end opening.
[0036] In some embodiments, in at least one cross-section of the port, the cross-sectional area of the first lumen is not concentrically disposed with the cross-sectional area of the second lumen. Alternatively or additionally, the sidewalls of the cross-section defining the second lumen are not evenly spaced from the longitudinally extending centerline of the first lumen and / or the circumferential portions of the cross-section are not all evenly spaced from the centerline.
[0037] In some embodiments of the port, the second lumen comprises at least one cross-sectional area that is smaller in a transverse direction than its height.
[0038] In some embodiments, the second lumen comprises at least one opening, e.g., a groove disposed on or in the sidewall defining the second lumen, preferably extending circumferentially around the second lumen or a portion thereof, which opening preferably leads to an opening in the second lumen that serves or can serve as a connection for connecting the second lumen to a drain or exhaust line using a connector.
[0039] In some embodiments, the first end opening of the first fluid guide faces further toward the interior of the port than the second end opening of the second fluid guide, i.e., is further inward, and is at least 5 mm, preferably at least 10 mm, and more preferably at least 15 mm further inward than the second end opening of the second fluid guide.
[0040] In some embodiments, the cross-sectional area of the second lumen constantly and / or continuously increases in the axial direction from a cross-section where the opening plane of the first end opening of the first lumen also exists to the beginning of the opening, e.g., to the beginning of the groove.
[0041] In some embodiments, the inner wall of the first lumen is designed to at least partially converge or diverge toward the first opening. The angle can be, for example, 2°.
[0042] In some embodiments, the wall or outer wall surrounding the connector lumen is at least partially shaped to diverge or taper toward the opening of the connector lumen, the angle being, for example, 2°.
[0043] In some embodiments, the inner wall of the first lumen and the wall surrounding the connector lumen or outer wall are inclined at the same angle relative to the centerlines of the lumens.
[0044] In some embodiments, the first lumen is conically tapered only in the first third of the first fluid guide, or only in the first 1.5 mm to 3 mm. The opening angle of the first fluid guide can be, for example, 10° to 20°, preferably 15°. The insertion bevel thus formed can help prevent unwanted contact between the front sides or between the front faces.
[0045] In some embodiments, the length of the first fluid guide, including the optional tapered region, is 30 mm or less or 35 mm or less.
[0046] In some embodiments, the radially outer limit or outer wall of the first fluid guide is spaced apart from the respective radially inner surface of the inner or side wall of the second lumen over the entire or at least a portion of the free length of the first fluid guide, the distance being at least 5 mm, preferably at least 8 mm, where the free length can be the portion of the first fluid guide that protrudes into the second lumen.
[0047] In some embodiments, the cross-sectional area of the first lumen decreases seamlessly and / or continuously over a predetermined distance in the axial direction away from the first end opening of the first fluid guide, starting from a cross-section where the opening plane of the first opening of the first fluid guide is also present, preferably at least 10 mm, particularly preferably at least 20 mm or at least 30 mm.
[0048] In some embodiments of the port according to the present invention, the edge or wall of the second end opening comprises at least one fillet or concave radius in the thickness of the edge or wall. These provide a defined entry point for air that enters when the rinse cap closing the second end opening of the second lumen is opened during use of the port and due to the momentary negative pressure generated in the port when the rinse cap is pulled away from the port. If the fillet is preferably provided at the upper edge portion, air will enter the port there and therefore enter the port at a location where less residual liquid remains due to gravity than in other areas, such as the lower area. The fillet(s) prevent the formation of a liquid cylinder around the rinse cap if liquid residue forms in the outer area of the rinse cap before opening it. This has the advantage that the liquid cylinder does not implode when the rinse cap is pulled off, which can lead to droplet formation, dispersion, and aerosol formation, thereby carrying or transporting residual liquid particles into or out of the port.
[0049] In some embodiments, the port further comprises a leak sensor, preferably a conductivity sensor. The leak sensor preferably protrudes into the second lumen, i.e., protrudes from the sidewall and terminates freely. The leak sensor preferably is or comprises a pin, ring, or tube.
[0050] In some embodiments, the leak sensor carries or includes an insulating layer, which can prevent inaccurate measurements due to residual moisture, especially if the leak sensor protrudes beyond the wall to which it is connected.
[0051] In some embodiments of the port, the second lumen, in particular the inner surface of the inner wall or side wall of the second lumen, comprises a recess in its lower region. In a longitudinal cross section through the centerline of the first fluid guide, the recess has a greater extension below at least two or all planes parallel thereto. The longitudinal cross section may correspond to or be parallel to the drawing plane of Figure 1 or Figure 2.
[0052] In some embodiments, the second lumen, particularly the inner surface of the inner wall or side wall of the second lumen, comprises a recess in its lower region, which in at least one cross section that does not extend parallel to either the longitudinal cross section or the cross section of the second lumen comprises a triangular or wedge-shaped portion, with the tip of this shape directed toward the inside of the port.
[0053] In some embodiments of the medical treatment device according to the present invention, the edge of the fastening portion extends annularly at a first portion thereof at or below the inner radius, i.e., at a constant curvature. A second portion of the edge has an inner radius and is not part of the ring shape formed by the first portion, and therefore does not extend below the constant inner radius of the first portion.
[0054] In some embodiments, the treatment device comprises a swivel lever, which is arranged to pivot about a pivot axis preferably perpendicular to the plane of the housing, the swivel lever comprising a receiving portion and / or a stop.
[0055] The optional receiving portion is provided for releasably receiving a rinse cap used to temporarily close the second lumen of the second fluid guide by or after pivoting the swivel lever to the first pivot position of the swivel lever. To close the second lumen, the swivel lever is rotated or pivoted until the rinse cap received in the receiving portion is in front of the second lumen of the second fluid guide. In some embodiments, the optional receiving portion releasably comprises a rinse cap, particularly as described herein.
[0056] The optional stop is provided to temporarily prevent axial separation movement that would disconnect the single-use connector from the fastening portion, i.e., for example, by withdrawing the connector from the port. This axial separation movement is prevented by or after pivoting the swivel lever to its second pivot position, for example, where the swivel lever stop is located in front of the connector.
[0057] In some embodiments, a sensor is provided, thus connected, for example, in signal communication with a control device of the treatment device, to detect a handle position or predetermined positions that the handle is or may be in. Thus, successful or sufficient connection of the disposable to the port, as well as optionally its disconnection, can be determined, monitored, etc. Alarms, indications, notifications, etc. can be provided by the signal coming from this sensor, as well as optional intervention under the control of the treatment device, which can be configured to block or interrupt a predetermined treatment option or function of the treatment device, for example, if the signal does not correspond to or corresponds to a particular specification.
[0058] In some embodiments, the rinse cap, which serves to temporarily close the second opening of the port, comprises a front side or front surface that faces the interior of the medical treatment device during use of the rinse cap, which comprises an axially and / or radially raised edge on its circumference.
[0059] In some embodiments, the rinse cap further comprises a first recess or first groove extending on or within a circumferential side thereof.
[0060] In some embodiments, the rinse cap also preferably comprises a second recess or second groove extending on or within the circumferential side axially adjacent the raised edge.
[0061] In some embodiments, the raised edge of the rinse cap comprises a wedge-shaped or triangular portion in a longitudinal cross section of the rinse cap. This portion may have an isosceles triangle profile and / or extend toward the tip at equal angles on both sides. In this way, certain embodiments can ensure that less residual liquid remains in the port after the rinse cap is disconnected.
[0062] In some embodiments of a medical procedure device according to the present invention, the swivel lever is arranged to pivot about the pivot axis to a third pivot position in which neither the receiving portion for releasably receiving the rinse cap nor the stop for temporarily preventing axial separation movement for separating the connector of the disposable is located axially in front of the second lumen of the port.
[0063] In some embodiments of the system, the rinse cap comprises an outer edge having a rounded edge portion that is preferably rounded or has an outer radius that corresponds to 90% to 99.9% of the inner radius of the first portion of the edge of the treatment device.
[0064] In some embodiments of the treatment device, the swivel lever comprises a recess or groove, which is designed to accommodate a portion of the edge of the end plate or end disk of the connector, such that by pulling the swivel lever, for example by pulling its handle, the recess into which the edge of the end plate or end disk is inserted not only causes the swivel lever to release the port, but also simultaneously withdraws the connector from the port.
[0065] In some embodiments of the treatment device, the port is received in its fastening portion so that the centerline of the first fluid guide or first lumen is inclined by 4° or more relative to the surface on which the medical treatment device is placed.
[0066] In some embodiments, the medical treatment apparatus comprises a displacement device by which the swivel lever can be translated or guided along the pivot axis. The displacement device can be part of the swivel lever. Preferably, the swivel lever can be translated or guided only a limited or predetermined distance using the displacement device. A limit stop can be provided for this purpose. Preferably, the displacement or guidance occurs during use and / or without the use of tools.
[0067] In some embodiments, the port or treatment device includes a return element, e.g., a spring, that acts to translate the receiving portion and / or to axially pretension the receiving portion. Alternatively or additionally, the port or treatment device includes a damper device for damping translational movement caused by the return element.
[0068] In some embodiments of the treatment device, the rinse cap is sized so that when the rinse cap is inserted into the port, the first and second recesses or grooves of the rinse cap are in fluid communication with each other. This allows fluid to flow, preferably axially, along the exterior of the rinse cap from the first groove or recess to the second groove or recess, or vice versa. The second groove or recess results from a special design of the front or front edge of the rinse cap, as described in more detail below.
[0069] In some embodiments of the system, the connector comprises a ribbed structure on its exterior, preferably extending to a connection opening intended to be at least partially inserted into the second lumen of the port when the connector is connected to a medical treatment device, or to the front end of the disposable or connector.
[0070] In some embodiments, the rib structure comprises adjacent ribs that laterally define recesses present or disposed therebetween, wherein the distance over which the cross-sectional area of the rib structure occupies the recesses on the outer circular circumference of the connector, not formed by the ribs but by the gaps between the ribs, is preferably 5% to 15%, particularly preferably 10% to 12%, or more, of the cross-sectional area of the connector.
[0071] In some embodiments of the system, the connector comprises a disk structure. The disk structure preferably has a rounded edge portion having an outer radius corresponding to 90% to 99.9% of the inner radius of the first portion of the connector's edge. Alternatively or additionally, the outer radius of the disk structure is at most 1 mm, preferably at most 0.5 mm, and particularly preferably at most 0.1 mm, smaller than the inner radius of the first portion. Alternatively or additionally, the outer edge portion or outer radius of the disk structure has a maximum distance to the first portion of the edge of 1 mm, preferably at most 0.5 mm, and particularly preferably at most 0.1 mm.
[0072] The ribs or different suitable surface structure can create a non-gas-tight connection between the connector and the second opening that receives it. Thus, when the connector is pressed into the port, the connector does not push or pull into the interior of the port residual liquid that may be adhering to the inner wall formed by the second opening. Instead, or rather, the ribs can capture such liquid residual between them, possibly also utilizing capillary forces, which is why liquid residual can remain on the connector.
[0073] Such ribs may also act as a venting option in that they ensure rapid pressure equalization when the connector is inserted into the port or when the connector is withdrawn from the port.
[0074] As a ventilation option, the ribs can also vent compressed air blown into the port for cleaning or drying purposes. This favors air distribution inside the port, resulting in complete or more rapid drying of residual liquids, which counteracts the spread of bacteria through liquids during the procedure.
[0075] In some embodiments, the connector comprises a connector having a flowable lumen by which a mostly flexible fluid line is connected to a mostly rigid connector, the flowable lumen of the connector and the flowable lumen of the connector lumen forming an angle of between 80° and 100° with respect to each other.
[0076] In some embodiments, the connector comprises a contact protection cover having a free connection opening, and inside the contact protection cover, the connector lumen surrounded by a wall terminates in an opening, wherein the free connection opening and the wall opening preferably have a minimum distance from each other of at least 10 mm.
[0077] In some embodiments, the connector includes a drip disk disposed between the disk structure and the rib structure or between the disk structure and the contact protection cover.
[0078] As used herein, the term "fluid guide" generally refers to a physical or bodily arrangement of elements provided for receiving and / or conducting, guiding, etc. fluids in certain embodiments of the present invention. Tubes, hoses, channels, lines, chambers, fluid guide devices, etc. are examples of such elements.
[0079] In certain embodiments of the present invention, the first fluid guide is provided to guide or drain medical fluid from an outlet opening (i.e., from a port) of the first fluid guide, for example into the environment, externally, into a connected disposable, etc.
[0080] The term "medical fluid" as used herein generally refers in certain embodiments of the invention to liquids such as dialysate, substitution fluid, medication, priming and / or rinsing and / or sterilizing fluids, and the like, and gases, e.g., sterile air, and any combination or mixture thereof. In certain embodiments of the invention, the medical fluid is suitable for and / or provided for or intended for extracorporeal blood treatment.
[0081] In certain embodiments of the present invention, the medical fluid is a substitution fluid, which in some embodiments of the present invention is a substitution fluid that is generated online by a treatment device.
[0082] The rinse cap used in certain embodiments of the present invention refers to a closure device designed and / or provided to close or seal the port from the exterior of the port by closing or sealing the second opening of the second lumen. Preferably, it may be a closure cap.
[0083] The rinse cap may fluid-tightly close the port according to the present invention from the outside, and the lumen of the port may be in fluid communication with the interior of the rinse cap.
[0084] In certain embodiments of the present invention, a rinse cap is provided to allow or facilitate cleaning of the port.
[0085] The rinse cap may be designed to be automatically or automated pivotable and / or displaceable.
[0086] In certain embodiments of the invention, the connector or its end portion comprises or consists of, for example, PEEK (polyetheretherketone) or a mixture of PEEK and PTFE (polytetrafluoroethylene). These materials or similarly provided combinations of materials can advantageously reduce the connection force to be overcome at the port due to their good sliding properties.
[0087] In certain embodiments of the invention, the port according to the invention comprises a hydrophilic coating on at least some parts or is made from a hydrophilic material in these parts.
[0088] In certain embodiments of the present invention, a hydrophilic coating of the port and / or rinse cap may be preferred, for example, to minimize droplet flight during removal or pivoting of the rinse cap.
[0089] In some embodiments, the port of the present invention is part of a machine-side substitution fluid system of a medical treatment device.
[0090] In certain embodiments, the ports in the medical treatment device are angled relative to the horizontal.
[0091] In certain embodiments, the port may be mounted at an angle of 8°±3° relative to the horizontal.
[0092] In some embodiments of the present invention, the port is positioned such that, in at least one position (e.g., rinse position, connection position), its first lumen is inclined relative to the horizontal, as described above, with the free end of the first lumen lower than the remainder. Such an inclination, particularly in combination with an optional hydrophilic coating or material on the inner wall of the second lumen, can promote the formation of a non-stick or non-tearable film of residual liquid migrating toward the connection for the drain or discharge line. This film can be discharged from the port through the drain or discharge line with little residue.
[0093] In certain embodiments, the treatment device according to the invention is designed 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, blood transfusion, etc.
[0094] In a particular embodiment of the invention, the treatment apparatus according to the invention comprises at least one device for introducing air into the second fluid guide.
[0095] As used herein, a "device for introducing air" in certain embodiments of the invention comprises a system or arrangement designed to introduce or supply air, such as by blowing and / or aspirating air, into the second fluid line.
[0096] In certain embodiments, the device for introducing air comprises means for generating sterile air or sterile compressed air, for example from ambient air, such as at least one filter or sterilizing filter, and a compressor, etc. The control device of the treatment apparatus may be provided and the compressor provided for suitable control or closed-loop control to empty the port by filling it with compressed air before opening the rinse cap, thereby pre-removing most of the liquid from the port, preferably before opening the rinse cap.
[0097] The device for introducing sterile air may be provided anywhere within the second fluid guide, but may be provided at a location different from the second opening or the free end of the second lumen.
[0098] In some embodiments, the port does not have a spring element, for example to displace the first fluid guide axially within the port against a spring force.
[0099] In some embodiments, the port does not have threads and / or threads provided for connecting a disposable item to the port.
[0100] In some embodiments, the outer diameter of the first fluid guide is constant at least in the free region of the first fluid guide.
[0101] In some embodiments, the rib structure comprises ribs having or being at least two or exactly two lengths that differ from one another.
[0102] In some embodiments, some of the ribs of the rib structure extend to the connection opening or to the front end of the disposable or connector that is intended to be inserted into the second lumen of the port when the connector is connected to a medical treatment device, while others do not.
[0103] In some embodiments, some or all of the ribs, particularly in the rib structure, have at least one non-rounded, sharp-edged, or rectangular longitudinal boundary or edge in their cross-section, particularly at the transition to an adjacent recess, at least over the portion of each rib under consideration. The longitudinal boundary or edge may have, for example, a radius of 0.1 mm or less, preferably 0.05 mm or less, which may result in or create a sharp edge.
[0104] In some embodiments, the connector has a drip disk and a disk structure, where the ribs are disposed between the drip disk and the disk structure, preferably extending at an angle of 75° to 105° relative to the flowable lumen of the connector and / or parallel to each other, such that they face away from the central axis of the lumen surrounding the rib structure at the angle indicated here and / or are parallel to each other.
[0105] In some embodiments, the rib structure comprises at least 16, preferably at least 18, particularly preferably at least 20 or exactly 20 ribs distributed around the circumference of the touch protection cover.
[0106] In some embodiments, the disposable comprises, for example as an end, a non-circular end plate or disc.
[0107] In certain embodiments, the edge defining the first opening is spaced a distance from the interior wall of the second lumen that is no less than 5 mm, 6 mm, 7 mm, or 8 mm.
[0108] In some embodiments, the port and disposable are designed such that when the port and disposable are inserted into one another or in use, a wall surrounding a connector lumen of the connector that guides fluid during use is at least partially inserted into a first lumen of a first fluid guide of the port.
[0109] In some embodiments, the length of the contact protection cover is determined so that the front side or front face of the contact protection cover surrounding the connection opening is guided through the inner wall of the second end opening or the adjacent second lumen of the port during insertion of the connector into the second lumen of the port so as not to be able to come into contact with the first fluid guide, in particular with its end opening and / or the front limit of the end opening.
[0110] In some embodiments, the first end opening of the first fluid guide of the port faces further towards the interior of the port than the second end opening of the second fluid guide.
[0111] In some embodiments, the length of the contact protection cover and / or the distance between the free connection opening and the opening of the connector lumen is set so that the front side or front face of the opening of the connector and / or the walls of the opening cannot come into contact with the first fluid guide, in particular its end side opening or front side defining portion, during insertion of the connector into the second lumen of the port.
[0112] In some embodiments, the system further comprises a medical treatment device comprising a housing (and / or comprising a port) having a fastening portion for connecting the medical treatment device to the port, the fastening portion optionally comprising an edge that protrudes over and / or is raised relative to an adjacent housing portion.
[0113] In some embodiments, the medical procedure device includes a swivel lever arranged to pivot about a pivot axis, the swivel lever having a stop for temporarily preventing axial separation movement to separate the connector of the disposable from the fastening portion upon or after pivoting the swivel lever to the second pivot position of the swivel lever, the stop being specifically designed to interact with an end plate or disk of the disposable to limit rotation of the inserted connector about the longitudinal axis of the connector lumen.
[0114] In some embodiments, some or all of the externally accessible portions or parts of the swivel lever (e.g., handle, stop, etc.) are so large that they cannot protrude or push into the interior of the touch protection cover or reach the opening of the internal connector. This geometrical matching of the swivel lever and the touch protection cover can help prevent accidental contact with at least the connector by non-sterile portions of the swivel lever.
[0115] In some embodiments, the outer edge portion or outer radius of the disc structure is spaced or separated from the second portion of the edge by at least 3 mm, preferably 4 mm, 4.6 mm, or more.
[0116] In some embodiments, the disk structure has a thickness of less than 1.5 mm, particularly preferably a maximum of 1 mm. Alternatively or additionally, a disk structure having a thickness of less than 1.5 mm, particularly preferably a maximum of 1 mm, may be inserted or insertable into the edge.
[0117] In some embodiments, the disposable item is part of and / or is directly or indirectly connected to a flexible fluid line that is also preferably designed or provided as a disposable or single-use item.
[0118] In some embodiments, a connector is provided for insertion, for example, into a port, and the connector may protrude and / or be provided to be manually grasped for that insertion.
[0119] In some embodiments, all or part of the ribs or longitudinal extensions of the ribbed structure extend longitudinally of the connector or parallel to the flow direction of the connector.
[0120] In some embodiments, all or some of the ribs of the rib structure do not extend circumferentially around the connector.
[0121] In some embodiments, the disposable or its connector does not comprise or is not a drip protection comprising or consisting of concentric rings or grooves.
[0122] In some embodiments, the disposable is not part of the blood cassette or part of the treatment device.
[0123] In some embodiments, the wall surrounding the connector lumen is spaced from the inner wall of the touch protection cover, preferably by at least 3 mm or more.
[0124] In some embodiments, the connector or the wall surrounding the connector lumen is not moveable or slidable within or relative to the disposable, and is not within the disposable or the connector.
[0125] In some embodiments, the connector or the wall surrounding the connector lumen is not moveable or slidable within the treatment cassette, eg, a blood treatment cassette.
[0126] In some embodiments, the swivel lever is not intended to be rigidly connected to the rinse cap.
[0127] In some embodiments, the walls defining the first and / or second lumens do not have spherical or otherwise shaped local thickenings, widenings, or bulges of any kind.
[0128] Some or all of the embodiments of the present invention may have one, some, or all of the advantages set forth above and / or below.
[0129] The present invention provides a port that can advantageously meet the highest hygiene requirements for medical procedures.
[0130] The present invention advantageously ensures an environment that is as sterile as possible at the connection between the disposable and the blood treatment device. This can help prevent the ingress of bacteria into the patient's blood, thereby improving patient safety. This results from the additional reduction in residual fluid in the area of the port's second fluid guide, which can be preceded by first emptying the port by introducing air, which is why, for example, only a small amount of residual fluid (typically about 5 μl to 10 μl) remains in the port.
[0131] A further advantage of the present invention may be that it also reduces or prevents aerosol-mediated bacterial transfer to the opening of the first fluid guide, which can occur due to dynamic under- and over-pressure conditions during rapid movements during connection and disconnection of the disposable and rinse cap, even when the residual liquid volume is very small.
[0132] By avoiding contact between the inner or first fluid guide and the outer or second fluid guide, the formation of so-called "liquid bridges" is advantageously prevented, which also contributes to reducing or avoiding the transfer of bacteria into the blood circuit, thereby contributing to improved patient safety.
[0133] The conductivity sensor makes it possible to detect micro-leaks in the port during treatment or residual liquid after emptying.
[0134] A further advantage may be that the inside of the port is protected from contact by operating personnel, which also helps to prevent or avoid the introduction of bacteria into the patient's blood circuit.
[0135] In this way, the use of a port according to the present invention can be advantageous as it ensures sterility even when a moist environment prevailing on or within the connector, which would normally pose a risk of bacterial accumulation, thereby minimizing or eliminating the risk of contamination to the user and / or patient.
[0136] An optional hydrophilic coating on or in the port, especially at its end portion, can further advantageously contribute to preventing droplets from flying when the connector is opened.
[0137] A further advantage may be to address residual fluid in the port before disconnecting the disposable, which liquid can be collected and sent or directed to a drain or evacuation line, thus optimizing emptying of the port.
[0138] A further advantage is that when the disposable or rinse cap is inserted, a very narrow gap is formed in the upper region of the closure toward the port lumen, allowing liquid on the device surface to be drawn inward by capillary forces and then trickle down the disposable or rinse cap. If the fastening portion edge is designed with an annular shape, liquid would collect in the lower region of the disposable or rinse cap. However, due to the large gap between the front of the machine and the disposable or rinse cap in the lower region, the liquid can escape and not reach the inside of the port. This advantageously avoids a sealing closure against the front of the machine, which would lead to the formation of droplets or aerosols during the connection and disconnection processes due to pressure equalization.
[0139] Some or all of the advantages achievable with the ports of the present invention may still be achieved with the disclosed rinse caps, medical treatment devices of the present invention, and / or systems of the present invention.
[0140] The present invention will now be described with reference to the accompanying drawings, in which like reference numbers indicate similar or identical elements. [Brief explanation of the drawings]
[0141] [Figure 1] 1A and 1B illustrate schematically a port according to the present invention for fluidly connecting a disposable item to a medical treatment device. [Figure 2] An enlarged detail of FIG. 1 is shown. [Figure 3] 2 shows the port of FIG. 1 in a longitudinal section and in a perspective view from the right. [Figure 4] 1 shows a front or side view of a medical treatment device, partially together with a view of its housing portion. [Figure 5] 1 shows a connector for a disposable item that is only partially shown. [Figure 6] 6 shows a partial cross-sectional view of the connector of FIG. 5. [Figure 7]1 shows a simplified longitudinal cross section of the connection between a port and a connector. [Figure 8] Two ports are shown, each received in a fastening portion of the housing. [Figure 9] 1 is a simplified schematic diagram of a fluid line structure of a medical treatment device according to the present invention; DETAILED DESCRIPTION OF THE INVENTION
[0142] FIG. 1 shows a port 100 according to the present invention in a first embodiment.
[0143] The port 100 comprises a first fluid guide 3 having at least a first lumen 31 and a first end opening 32. The first lumen 31 is capable of flowing in a longitudinal direction indicated by its centerline M. Fluid present in the first lumen 31 can exit the first fluid guide 3 through the first end opening 32.
[0144] Port 100 further comprises a second fluid guide 5 having at least a second lumen 51 and a second end opening 52. For reference, second end opening 52 in the embodiment of Figure 1 is understood or referred to as a transition from the exterior A (referred to herein as "A" for the letter A with an umlaut, and the same applies hereinafter) of medical procedure device 2000 (shown only diagrammatically in Figure 1) to the interior I of port 100 or medical procedure device 2000.
[0145] The first fluid guide 3 is located inside the second fluid guide 5, and with reference to the port 100, its first end opening 32 is located further inside I (i.e., further inside) the port 100 or medical treatment device 2000 (shown only schematically in FIG. 1) than the second end opening 52 of the second fluid guide 5.
[0146] The second end opening 52, which may be an opening, is provided for inserting a portion of the connector 4001 (see FIG. 5) of the disposable item 4000 therethrough into the interior of the port 100 for the purpose of establishing a fluid connection between the first fluid guide 3 and the connector lumen 4004 (see FIG. 6). The second end opening 52 should thereby preferably guide the connector 4001 into a stable position.
[0147] During intended use, the port 100 serves to establish a fluid connection between at least one fluid line 2002 of the medical treatment device 2000, which is assigned to, facing or dedicated to the interior I of the medical treatment device 2000, on the one hand, and a connector 4001 of a fluid line 4002 of a fluid-guiding disposable item 4000, which is assigned to the exterior A of the medical treatment device 2000, on the other hand. This connection is preferably made at the end portion 1 of the port 100.
[0148] Figure 1 shows a fastening portion 2003 for fastening port 100 to medical treatment device 2000 (shown only diagrammatically in Figure 1), in which port 100 passes through a housing portion of housing 2001 of medical treatment device 2000, which is defined by adjacent housing portion 2005.
[0149] 1 shows port 100 in an unconnected state to connector 4001. Port 100 is closed with rinse cap 200. Thus, FIG. 1 shows port 100 in its "rinse" or "closed" state.
[0150] The rinse cap 200 placed on the port 100 closes the second end opening 52, thereby sealing the interior of the port 100 and the two fluid guides 3, 5 from the exterior of the port 100 and / or the medical treatment device. To this end, the outer edge 202 of the rinse cap 200 is fluid-tightly placed on or within the port 100, with the front / end face 205 of the rinse cap facing the interior I.
[0151] The rinse cap 200 may have a first groove 204 on or around its circumference, which is described in more detail below.
[0152] The housing 2001 optionally comprises an edge 2007 (see FIG. 4) that completely or at least partially surrounds the fastening portion 2003. The edge 2007 comprises a first portion 2007a and a second portion 2007b, which are described in more detail with reference to FIG.
[0153] In the end region of the second lumen 51 opposite the second end opening 52, at least one opening 54 may be provided in or on its side wall, this opening 54 being in front of the drawing plane and therefore not visible in Figure 1 due to the section lines, but is shown in Figure 3, the function of which will be explained below with reference to the description of Figure 3.
[0154] For example, a leak sensor 2031 is optionally provided to give early information in case of a leak from the fluid connection established between the fluid line 2002 of one medical treatment device 2000 and the fluid line 4002 of the other. Corresponding voltage sources, lines, evaluation devices, and alarm devices may be provided and suitably programmed as required.
[0155] Figure 1 further shows a receiving portion 2015 as part of the swivel lever designated in Figure 8 by reference numeral 2011. The receiving portion 2015 of the swivel lever (not further shown in Figure 1), here shown by a screw, serves to releasably receive at least one portion of the rinse cap 200 therein.
[0156] Also visible is the handle portion 2013 of the swivel lever, which allows the user to pull the handle portion axially (i.e., to the left in FIG. 1) to withdraw the rinse cap 200 from the port 100, thereby terminating the rinse position.
[0157] It can be seen that the second lumen 51 of the second fluid guide 5 comprises at least one longitudinal portion, the side walls of which (top and bottom in the cross-sectional view of FIG. 1 ) are oriented along or parallel to the centerline M (left and right in FIG. 1 ), but are not parallel to each other and / or at a fixed angle to each other. Rather, the cross-sectional area of the second lumen 51 increases continuously or even uninterruptedly over a distance to the right, i.e., from the second end opening 52 to the right.
[0158] Second lumen 51 optionally comprises a first cross-sectional area defined by a sidewall of second lumen 51, the first cross-sectional area being smaller than any other cross-sectional area of second lumen 51 defined by a sidewall of second lumen 51 facing further toward interior I of second lumen 51 than the first cross-sectional area, and further toward the right in FIG. 1 as seen from at least a region before first end opening 32. This causes second lumen 51 to at least partially widen toward interior I.
[0159] FIG. 1 further illustrates that first lumen 31 may optionally terminate in a funnel or diverging shape at first end opening 32 .
[0160] An opening for a sterile air inlet line 47 may be provided which may be connected to a source of compressed air, such as, for example, medical treatment device 2000. This is preferably located at the end of second lumen 51 opposite second end opening 52, preferably in the upper side wall of port 100.
[0161] After cleaning or disinfecting, sterile air may be introduced through the sterile air inlet line 47 before opening the rinse cap 200 to connect the disposable item 4000, thereby removing most of the cleaning or rinsing solution present in the port 100.
[0162] The cross-sectional area of the second lumen 51 increases continuously and / or uninterruptedly in the axial direction from the cross section where the opening surface of the first end opening 32 of the first lumen 31 also exists to the beginning of the port opening, which radially widens the second lumen in at least one cross section and / or where the opening of the sterile air inlet line 47 exists.
[0163] As can be seen in FIG. 1 , the edge defining the first end opening 32 is spaced from the inner wall of the second bore 51. This distance is no less than 5 mm, 6 mm, 7 mm, or 8 mm. It can be seen that this distance is caused by the widening of the second bore 51 inward, i.e., to the right. Without the widening of the second bore 51, the distance between the edge and the inner wall of the second bore 51 would correspond to the difference between the radius of the outer periphery of the first fluid guide 3 and the radius of the inner periphery of the second end opening 52, and the defining sides would be parallel and / or at an angle to each other. However, due to the widening, the distance is larger—in this example, it is at least 1.1 times this difference. The resulting or enlarged step (compared to the embodiment without the widened portion shown in Figure 1) serves to protect against liquid bridging between any liquid that may remain on the inner wall of the second lumen 51 and the first end opening 32 of the first fluid guide 3, thereby ultimately protecting the patient from bacteria that may be transferred in this way.
[0164] FIG. 2 shows an enlarged view of a portion of FIG.
[0165] 2 shows that second end opening 52 may be present at or near the longitudinal (axial) portion where the circumferential surfaces forming second end opening 52 are parallel to one another. The portion of port 100 further inward and adjacent second end opening 52 contributes to the widened portion of second lumen 51 described above.
[0166] 2, the circumferentially closed first groove 204, which may have a U-shaped, V-shaped, or W-shaped profile in the longitudinal cross section of the rinse cap 200, allows liquid that impinges on the rinse cap 200 from the outside, most accidentally, for example, when cleaning the housing or when a liquid is spilled by staff or a patient, to be diverted downwards. The flow path thus established directs such liquid particularly away from the end regions of the rinse cap 200, through which the liquid may eventually reach the interior of the port 100.
[0167] Such flow paths are indicated by arrows.
[0168] The second circumferentially closed groove 208 results from a special design of the leading edge of the rinse cap 200 .
[0169] FIG. 3 shows a longitudinal cross-section of the port 100 of FIG. 1 in a right perspective view, showing the inside of the port 100 cut open and the front or front side 205 of the rinse cap 200 and its edge 207.
[0170] For reference purposes only, the reference section Q R is shown.
[0171] Reference cross section Q R While there may be cross sections of the second lumen 51 that have a circular cross-sectional area, as shown by the reference cross section Q in FIG. 3, the diagram in FIG. 3 also shows that the second lumen 51 may have at least one cross section that does not have a circular cross-sectional area. R It includes a cross section located to the right of, i.e., facing the interior I.
[0172] For example, when looking at a cross section in which the first end opening 32 is also located, it can be seen from this cross section shown in FIG. 3 that the second lumen 51 optionally has at least one cross-sectional area having an extension in the transverse direction Q that is smaller than the vertical height H extending in the up and down direction in FIG. 3.
[0173] Figure 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 concentrically arranged with the cross-sectional area of the second lumen 51, which, as already mentioned, is due to the fact that the second lumen 51 itself is non-cylindrical in the area or cross-section comprising the first fluid guide 3 or the first lumen 31.
[0174] Furthermore, Figure 3 shows that the cross-sectional and / or circumferential side walls defining the second lumen 51 need not be evenly spaced from the centerline M of the first lumen 31, as can be seen from a cross-section where the first end opening 32 is also located, or from a cross-section located further inward, i.e., to the right.
[0175] The at least one optional opening 54 of the port 100 already mentioned in relation to Figure 1 widens the second lumen 51 in the radial direction in at least one cross section. In the example of Figure 3, the groove 54 extends along a lower part of the circumference of the second lumen 51, in other examples along the entire circumference, preferably over a part of the circumference that in use is located below the first fluid guide, i.e. below the first fluid guide 3 in Figure 3.
[0176] The opening 54 preferably extends in a plane perpendicular to the centerline M of the first lumen 31, which may also be advantageous for manufacturing reasons.
[0177] As can be seen in FIG. 3, opening 54 is preferably at the end of second lumen 51 opposite second end opening 52 thereof.
[0178] Opening 54 may be connected via a line (not shown in FIG. 9) to a drain or discharge line 153 (FIG. 9) which may be in fluid communication with second lumen 51 via connection 48 (shown in FIG. 8).
[0179] Edge 207 may be designed to not protrude less than 90° (or in the range of 80° to 100°) from the axial centerline M of rinse cap 200 or port 100 in the inserted and / or relaxed state of rinse cap 200, as shown in FIG. 3 .
[0180] FIG. 4 shows a detailed front or side view of a medical treatment device 2000, along with a view of its housing portion including a fastening portion 2003 for fastening a port, such as port 100 according to the present invention.
[0181] The fastening portion 2003 is used to receive a port used for connection to a disposable item. The fastening portion 2003 serves in particular to receive the port 100 according to the present invention, such as the port 100 of the previous figure, in or on the housing 2001 of the medical treatment device 2000.
[0182] Such a port would in fact also be fastened to fastening portion 2003 shown in Figure 4. However, the port is not visible in Figure 4 because it is behind the plane of the drawing and is further covered by disposable connector 4001 (shown in cross section), other parts of which are not shown.
[0183] However, one can see the centrally located connector lumen 4004 with a center point C (shown here by way of example) and the cover plate of the touch protection cover 4017 (also shown in Figures 5 and 6). The full length of the connector 4001, cut for the purposes of illustration in Figure 4, is shown in Figure 5.
[0184] In Figure 4, the optional edge 2007 already mentioned in Figure 1 can be seen, which edge circumferentially or only partially defines the fastening portion 2003 from the adjacent housing portion 2005 and optionally projects beyond the housing portion in a direction out of the plane of the drawing.
[0185] The edge 2007 in FIG. 4 illustratively comprises a first portion 2007a, which comprises the path of a portion of a ring having a center point C corresponding to the center of the connector lumen 4004 of the connector 4001, which is partially shown in cross section.
[0186] The second portion 2007b of the edge 2007 is not part of the ring shape around the center point C formed by the first portion 2007a. The second portion 2007b defines a recess or depression 2009 in the fastening portion 2003, the base of which is not parallel or not mostly parallel to the surface of the adjacent housing portion 2005. The second portion 2007b, together with the first portion 2007a, forms the only, optionally circumferentially closed edge 2007. In the region of the recess or depression 2009, the lower edge of the only, optionally circumferentially closed edge 2007, i.e., the second portion 2007b, is further away from the center point C than the upper edge of the only, optionally circumferentially closed edge 2007, i.e., the first portion 2007a.
[0187] It can be seen that the connector 4001, and in particular its touch protection cover 4017 (see also FIG. 5), comprises on its outer wall a plurality of ribs 4003a and 4003b, respectively, the radial outer dimensions of which allow the connector 4001 to be pushed into the second lumen 51 with the desired fit.
[0188] 5 serves as an example of an optional flange for achieving a radial push-fit against the inner wall of first portion 2007a, thereby allowing it to cover the area defined by first portion 2007a but not the area defined by second portion 2007b.
[0189] Thereby, the disk structure 4009 may have an outer radius that is only slightly smaller than the inner radius of the first portion 2007a.
[0190] One or more fillets 52a, representing a reduction in the wall thickness of the second fluid guide 5, starting from the inside of the second end side opening 52, act as an early intake of air during the separation movement that separates the connector 4001 from the port 100 by pulling the connector 4001.
[0191] FIG. 5 shows a connector 4001 of a disposable 4000 (only partially shown), which further comprises a fluid line 4002, which may be or comprise a blood tubing set, a substitution fluid line, or the like.
[0192] The connector 4001 serves to fluidly connect the connector lumen 4004, visible in Figure 6, with the first lumen 31 of the first fluid guide 3 of the port 100 ("connected state"). For this purpose, the connector 4001 is at least partially inserted into the second lumen 51 of the port 100, and one end-side connection opening 4019 of the connector 4001 is at least partially pressed onto the first fluid guide 3, as shown in Figures 4 and 7.
[0193] The connector 4001 optionally comprises on the outside a rib structure 4003 which, in the connected state described above, is in radial contact with the inner wall of the second end opening 52 of the second fluid guide 5 .
[0194] The rib structure 4003 comprises adjacent ribs 4003a, 4003b with recesses 4007a, 4007b therebetween that are defined laterally axially or transversely by the ribs 4003a, 4003b due to the optional longitudinal paths of the ribs 4003a, 4003b.
[0195] The recesses 4007a, 4007b constitute 5% to 15%, preferably 10% to 12%, of the cross-sectional area of the connector 4001 in a cross-section of the connector 4001 (e.g., measured from the base of the rib to the tip of the rib, i.e., radially), which cross-sectional area of the connector in this cross-section has, for example, extensions or inner radii that extend to the side or front or front faces of the ribs considered in particular, which terminate or terminate the ribs 4003a, 4003b in the radial direction.
[0196] Furthermore, the connector 4001 may have a disk structure 4009 that is essentially perpendicular to the longitudinal central axis of the connector 4001 (the up-down direction in FIG. 5 ). The disk structure 4009 preferably has a rounded edge portion or a rounded edge portion having an outer radius. The outer radius corresponds to 90% to 99.9% of the inner radius of the first portion 2007a of the edge 2007. Alternatively or additionally, the outer radius of the disk structure 4009 is at most 1 mm, preferably at most 0.5 mm, and particularly preferably 0.1 mm, smaller than the inner radius of the first portion 2007a. Alternatively or additionally, the outer edge portion or outer radius of the disk structure 4009 has a distance or space from the first portion 2007a of the edge 2007 of at most 1 mm, preferably at most 0.5 mm, and particularly preferably 0.1 mm.
[0197] Connector 4001 includes a connector 4015 having a flow-through lumen, whereby a fluid line 4002 of disposable item 4000 is or can be connected to connector 4001. Through or at this connection, the flow-through lumen of connector 4015 and connector lumen 4004, or their centerlines, form an angle of, for example, 80° to 100° with respect to one another.
[0198] The connector 4001 has a contact protection cover 4017 that terminates in a free connection opening or end connection opening 4019. A connector lumen 4004, surrounded by a wall 4021, terminates in an opening 4023 inside the contact protection cover 4017. The free connection opening 4019 and the opening 4023 in the wall 4021 are preferably separated from each other by a minimum distance of at least 10 mm, preferably at least 14 mm.
[0199] At the end opposite the free or end-side connection opening 4019, the connector 4001 may have an end plate or end disk 4027, which may be disposed perpendicular to the centerline of the connector bore 4004. The end plate or end disk 4027 may protrude radially at or along its entire circumference onto any or all structures adjacent to it. The end plate or end disk 4027 may be adapted to be partially received by a groove in the swivel lever 2011 as the swivel lever 2011 is pivoted. This may facilitate removal of the connector 4001 when the handle portion 2013 of the swivel lever 2011 is pulled (see FIG. 8 ).
[0200] FIG. 6 shows the connector 4001 of FIG. 5 in partial cross section.
[0201] FIG. 7 shows a simplified longitudinal cross section of the connection between port 100 and connector 4001, although connector lumen 4004 is not shown.
[0202] It can be seen that when air is introduced into the second lumen 51 via the sterile air inlet line 47 to dry or empty the second lumen 51 (see the air flow path marked with an arrow), the air exits the second lumen 51 through the second lumen 51 of the second fluid guide 5, around the drip disk 4025 of the connector 4001, and essentially underneath the disk structure 4009 by passing through the ribs 4003 a, 4003 b or rib structure 4003 (not shown as they are not in the drawing plane due to the chosen cutting line), respectively, which disk structure 4009 provides a lower radial edge-to-edge flow resistance below than above, as the gap above towards the first portion 2007 a of the edge 2007 is intentionally kept smaller than the gap below towards the second portion 2007 b. As such, liquid impinging on the port from the outside, for example liquid spilled by staff or a patient, will not reach the inlet area of the port 100 disposed behind the disk structure 4009, but rather will flow further outward and downward along the disk structure 4009. The same advantageous effect can be achieved by selecting suitable geometric shapes for the port and rinse cap.
[0203] FIG. 8 shows two ports 100 each received in a fastening portion of the housing 2001 .
[0204] A swivel lever 2011 is arranged to be rotatable or pivotable about its own pivot axis S and is provided for each of the two ports 100 .
[0205] A connector 4001 of a disposable item (not further shown) is inserted into the port 100 shown at the top left. The corresponding swivel lever 2011 is pulled out of the housing 2001 as far as it should protrude from the port 100, so that there is space for the connector 4001 between the rear side of a stop 2017 of the swivel lever 2011 and the port 100. The stop 2017 serves as a protection against unintentional withdrawal of the connector 4001 from the associated port 100 in a direction along or parallel to the pivot axis S. It prevents the connector 4001 from moving towards the outside A and / or in a direction parallel to the pivot axis S. A return element 2041 may apply pressure against the connector 4001 by the stop 2017 in the direction of the port 100, thereby preventing the connector 4001 from sliding out.
[0206] To remove the disposable item 4000 or its connector 4001 from the port 100, the swivel lever 2011 can be pulled out of the housing 2001 by a few centimeters along the pivot axis S by the handle portion 2013 and then rotated or pivoted, for example counterclockwise, after this pulling. The pivoting can result in the release of the connector 4001 at the stop 2017, which also rotates about the pivot axis S by the pivoting movement, clearing a path for withdrawal from the port 100. When the connector 4001 is pulled out of the port 100 and thus separated from the medical treatment device 2000, the now-open second end opening 52 of the port 100 can be closed by the rinsing cap 200. For this purpose, the swivel lever 2011 is rotated clockwise until the rinsing cap 200, received in the receiving portion 2015, is in front of the second end opening 52. When the handle portion 2013 is released, the optional return element 2041 pulls the swivel lever 2011, and with it the releasably connected rinse cap 200, towards the second end opening 52. This movement ends when the rinse cap 200 is firmly seated on or in the second end opening 52. To enable this movement to be carried out in a controlled manner and to prevent the formation of flying droplets that may result from a sudden movement, a damping element may be provided that has a damping effect on the force exerted by the return element 2041.
[0207] Although not visible in the figures, the swivel lever 2011 includes a recess or groove for inserting or receiving a portion of the edge of the end plate or end disk 4027 of the connector 4001. For example, when the swivel lever 2011 is pulled to pivot the port 100 from a connected position where it is connected to the disposable item 4000 to another pivot position, this movement can cause the connector 4001 to be withdrawn from the port 100 in a controlled manner.
[0208] Figure 9 shows a procedure flow diagram of a medical treatment device 2000, here a blood treatment device, according to the present invention, connected to an extracorporeal blood circuit 300, which can be connected to a patient's vascular system (not shown) for procedures using double-needle access or for procedures using single-needle access, for example by using an additional Y-connector (reference number Y), as shown in Figure 9. The extracorporeal blood circuit 300 can optionally have a portion on or in a blood cassette.
[0209] The pumps, actuators, and / or valves within the area of the extracorporeal blood circuit 300 are connected to a medical treatment apparatus 2000 according to the present invention or to a control device 150 included therein.
[0210] The extracorporeal blood circuit 300 includes (or is connected to) a patient arterial tubing clamp 302 and an arterial connection needle of the arterial portion or of the patient arterial line, blood withdrawal line, or first line 301. The extracorporeal blood circuit 300 also includes (or is connected to) a patient venous tubing clamp 306 and a venous connection needle of the venous portion, of the patient venous line, blood return line, or second line 305.
[0211] A blood pump 101 is provided in or within the first line 301, and a substitution fluid pump 111 is connected to the dialysis fluid inlet line 104 for conveying fresh dialysis fluid, which is filtered in a further filter stage (F2) (substitution fluid). A substitution fluid line 105 may be fluidly connected to the dialysis fluid inlet line 104. Using the substitution fluid pump 111, substitution fluid may be introduced into a line section, for example, into the arterial line section 301 or the venous line section 305 of the extracorporeal blood circuit 300 (here, between the blood chamber 303b of the blood filter 303 and the venous air separation chamber or venous blood chamber 329), via the associated line 107a or 109a, by predilution via the predilution valve 107 or by postdilution via the postdilution valve 109.
[0212] Hemofilter 303 includes a blood chamber 303b connected to arterial line portion 301 and venous line portion 305. Dialysis fluid chamber 303a of hemofilter 303 is connected to dialysate inlet line 104, which leads to chamber 303a, and to dialysate outlet line 102, which conducts dialysate, i.e., spent dialysate, away from chamber 303a. Dialysis fluid chamber 303a and blood chamber 303b are separated from each other by a substantially semipermeable membrane 303c, which represents the dividing line between the blood side, which contains the extracorporeal blood circuit 300, and the machine side, which contains the dialysis fluid or dialysate circuit, which is shown to the left of membrane 303c in FIG. 9 .
[0213] The arrangement of Figure 9 includes an optional detector 315 for detecting air and / or blood. The arrangement of Figure 9 further includes one or two pressure sensors PS1 (upstream of the blood pump 101) and PS2 (downstream of the blood pump 101) (measuring the pressure upstream of the blood filter 303 ("pre-hemofilter")) at the points shown in Figure 9. A further pressure sensor may be provided downstream of the venous blood chamber 329, for example, pressure sensor PS3.
[0214] In FIG. 9, an optional single-needle chamber 317 is used as a buffer and / or compensation reservoir in a single-needle approach where the patient is connected to the extracorporeal blood circuit 300 using only one of the two blood lines 301, 305.
[0215] The arrangement of Figure 9 also includes an optional detector 319 for detecting air bubbles and / or blood.
[0216] An optional heparinization point 325 may be provided.
[0217] 9, mixing device 163 is shown, which provides predetermined mixtures for each solution from container A (for A concentrate via concentrate supply 166) and container B (for B concentrate via concentrate supply 168) for use by medical treatment apparatus 2000. The solutions include hot water from water source 155, for example heated in heating device 162 (online, for example as reverse osmosis water, or from a bag).
[0218] Pump 171, which may also be referred to as a concentrate pump or sodium pump, is fluidly connected to and / or conveys from mixing device 163 and a source of sodium, such as, for example, container B. Optional pump 173 can be seen assigned to container B, for example, for bicarbonate.
[0219] The optional compressor referred to herein has the reference number 175 and is connected to port 100 .
[0220] 9 further shows a drain or discharge line 153 for drainage. An optional heat exchanger 157 and a first flow pump 159 suitable for degassing complete the illustrated arrangement.
[0221] A further pressure sensor PS4 may be provided downstream of the hemofilter 303 on the water side, but preferably upstream of the ultrafiltration pump 131 in the dialysate outlet line 102, to measure the filtrate pressure or membrane pressure of the hemofilter 303. A further optional pressure measuring point P may also be provided.
[0222] The blood exits the hemofilter 303 and flows through an optional venous blood chamber 329, which may include a degassing device 318 and may be in fluid communication with a pressure sensor PS3.
[0223] 9 includes a control device or closed-loop control device 150, which may have a wired or wireless signal connection to any of the components mentioned herein, particularly or specifically to the blood pump 101, for controlling or regulating the medical treatment apparatus 2000.
[0224] By using a device for online mixing of the dialysis fluid, the sodium content can be varied within certain limits, as controlled by the control device 150. For this purpose, the measured values determined by the conductivity sensors 163a, 163b in particular can be taken into account. If it turns out that it is necessary or desirable to adjust the sodium content (sodium concentration) of the dialysis fluid or substitution fluid, this can be done by adjusting the delivery speed of the sodium pump 171.
[0225] Furthermore, the medical treatment device 2000 includes a means for transporting fresh dialysis fluid and dialysate. A first valve may be provided between the first flow pump 159 and the hemofilter 303, and the first valve opens and closes the inflow toward the hemofilter 303 on the inlet side. An optional second flow pump 169 that transports the dialysate through the drain line 153 may be provided, for example, downstream of the hemofilter 303. A second valve may be provided between the hemofilter 303 on the outlet side and the second flow pump 169, and the second valve opens and closes the outflow.
[0226] Furthermore, medical treatment apparatus 2000 optionally comprises a device 161 for balancing the flow into or out of machine-side dialyzer 303. Balancing device 161 is preferably located in the line section between first flow pump 159 and second flow pump 169.
[0227] The medical treatment apparatus 2000 further comprises means, such as an ultrafiltration pump 131, for precisely removing an amount of fluid from the balancing circuit that is predetermined by the user and / or the control device 150.
[0228] Sensors such as optional conductivity sensors 163 a, 163 b serve to determine conductivity, which in some embodiments is temperature compensated, and fluid flow upstream and downstream of the dialyzer 303.
[0229] Temperature sensors 165a, 165b may be provided as one or more of them, the temperature values provided by which may be used in accordance with the present invention to determine a temperature compensated conductivity.
[0230] A leak sensor 167 is optionally provided, which may be provided at or within the port 100.
[0231] Further flow pumps may be provided in addition to or as an alternative to that of reference numeral 169, for example.
[0232] In FIG. 9, each of the multiple optional valves is designated V, and the bypass valve is designated VB.
[0233] In some embodiments, the control device 150 determines electrolyte and / or fluid balance based on measurements of the optional sensors described above.
[0234] Filters F1 and F2 connected in series may be provided.
[0235] Even when non-pure water is used, the filter F1 serves, as an example herein, to produce a dialysis liquid of sufficient purity through the mixing device 163, which then flows through the hemofilter 303, for example using the countercurrent principle.
[0236] Illustratively, filter F2 serves herein to produce a sterile or sufficiently filtered substitution fluid, e.g., by filtering out pyrogens, from the sufficiently pure dialysis fluid that has left first filter F1, which can then be safely added to the blood flowing outside the patient's body and thereby ultimately added to the patient's body.
[0237] Medical treatment apparatus 2000 is optionally shown in Figure 9 as a device for hemo(dia)filtration, however, hemodialysis machines are also covered by the present invention, although not specifically depicted in the figures.
[0238] Possible locations of the port 100 according to the present invention within the medical procedure device 2000 can be seen.
[0239] The invention is not limited to the above-described embodiments, which serve as examples only.
[0240] The arrows shown in FIG. 9 generally indicate the direction of flow in FIG. [Explanation of symbols]
[0241] 100...Port 1...End part 3...First fluid guide (inner) 5...Second fluid guide (outside) 31...First lumen 32...First end opening 47...Sterile air inlet line 48...Connection for drain or discharge line 51...Second lumen 52...Second end opening 52a...Fillet 54...Opening, e.g., groove 57...recess A...External C…center point H...height Q: Transverse direction Q R …Reference cross section I…Internal M…Center line S…Swivel axis 2000...Medical treatment equipment 2001…Housing 2002...Fluid line 2003... Fastening or fixing part 2005...adjacent housing section 2007…Edge 2007a…Part 1 2007b…Second Part 2009…Dent 2011...Swivel lever 2013…Handle 2015…Reception part 2017…Stop part 2031...Leak sensor 2041...Return element 4000...disposable items 4001...Connector 4002...Fluid line 4003...Rib structure 4003a...Rib 4003b...Rib 4003c…Rib 4004...Connector lumen 4005...Rib 4007a...recess 4007b...recess 4009...Disk structure 4015...Connector 4017…Contact protection cover 4019...Connection opening 4021...wall 4023...Opening 4025...Drip disc 4027...End Plates or End Discs 101...Blood pump 102...Dialysate outlet line 104...Dialysis fluid inlet line 105...Replacement fluid line 107...Pre-dilution valve 107a...Line corresponding to or belonging to the pre-dilution valve 109...Post-dilution valve 109a...Line corresponding to or belonging to the post-dilution valve 111...Substitution fluid pump 131...Ultrafiltration pump 150...Control device 153...Drainage or discharge line 155…Water supply source 157...Heat exchanger 159...First flow pump 161...Balancing device 162...Heating device 163...Mixed Device 163a...Conductivity sensor 163b...Conductivity sensor 165a...Temperature sensor 165b...Temperature sensor 166...Concentrate supply section 167...Leak sensor 168...Concentrate supply section 169...Second flow pump 171...Pump, sodium pump 173...Pump, bicarbonate pump 175...Compressor 200...Rinse cap 202...Outer edge of rinse cap 204...First groove 205...Front or front side of rinse cap 207...Front or front edge 208...Second groove 300...Extracorporeal blood circuit 301...First line (arterial line part) 302...(first) tube clamp 303...Blood filters or dialysis machines 303a...dialysis fluid chamber 303b...Blood chamber 303c…Semi-permeable membrane 305...Second line (intravenous line) 306...(Second) Tube Clamp 315...Detector 317...Single needle chamber 318...Degassing device 319...Detector 325…Heparin addition point 329...Venous blood chamber (optional) F1...Filter F2...Filter A…Container B…Container P...Pressure measurement point PS1...Arterial pressure sensor (optional) PS2...Arterial pressure sensor (optional) PS3...Pressure sensor (optional) PS4...Pressure sensor for measuring filtrate pressure (optional) V...valve VB: Bypass valve Y...Y connector
Claims
1. a port allocated inside a medical treatment device for establishing fluid communication between at least one fluid line of the medical treatment device and a connector of a fluid line of a disposable item allocated outside the medical treatment device, the port comprising: a first fluid guide having at least a first lumen and a first end opening, provided for receiving and / or guiding a medical fluid and for establishing said fluid communication with said connector; a second fluid guide having at least a second lumen and a second end opening; At least The first end opening of the first fluid guide is at least partially disposed within the second lumen of the second fluid guide.
2. 2. The port of claim 1, wherein the second end opening of the second fluid guide has a cross-sectional area smaller than the cross-sectional area of the second lumen located further inside / towards the interior of the medical treatment device than the second end opening, and the outer diameter of the first fluid guide is preferably constant, particularly in the region where the cross-sectional area of the second lumen increases in the axial direction.
3. 3. The port of claim 1 or 2, wherein the second lumen has a first cross-sectional area defined by a sidewall of the lumen, the cross-sectional area being smaller than any other cross-sectional area of the second lumen defined by the sidewall of the second lumen that faces or is disposed further toward the interior of the port or the medical treatment device than the first cross-sectional area.
4. The port of any one of claims 1 to 3, wherein the second lumen does not comprise a circular cross-sectional area in at least one cross section.
5. The port of any one of claims 1 to 4, wherein the first lumen terminates in a funnel or diverging shape at the first end opening.
6. The port of any one of claims 1 to 5, wherein the second lumen comprises at least one cross-sectional area that is smaller in a transverse direction than its height.
7. A port according to any one of claims 1 to 6, wherein the radially outer limit of the first fluid guide is spaced or separated from the radially inner surface of the side wall of the second lumen by at least 5 mm, preferably at least 8 mm, over the entire length of the first fluid guide or at least partly.
8. A port according to any preceding claim, further comprising a leak sensor, preferably a conductivity sensor, preferably protruding into the second lumen, and preferably being or comprising a pin or a ring.
9. A port according to any one of claims 1 to 8, wherein the second lumen, in particular the inner surface of the side wall of the second lumen, comprises a recess in at least one portion or cross section that does not extend in a longitudinal cross section or parallel to a cross section of the second lumen, comprising a portion having a triangular or wedge shape.
10. 10. A medical treatment device comprising a housing having a fastening portion for connecting said medical treatment device to a port according to any one of claims 1 to 9, said fastening portion preferably protruding onto or beyond an adjacent housing portion, preferably comprising a raised or protruding edge.
11. 11. The medical procedure device of claim 10, wherein the rim extends annularly at or below an inner radius in a first portion, and a second portion of the rim has the inner radius and is not part of the annular shape formed by the first portion.
12. A swivel lever is arranged to pivot about a pivot axis, and the swivel lever a receiving portion for releasably receiving a rinse cap for temporarily closing the second lumen of the second fluid guide by or after pivoting the swivel lever to its first pivot position, and / or a stop for temporarily preventing axial separation movement for separating the connector of the disposable article from the fastening part by or after pivoting the swivel lever to its second pivot position; Equipped with 12. The medical treatment device of claim 10 or 11, wherein a rinse cap is releasably received in the receiving portion to temporarily close an opening of a port, the port serving to establish fluid communication between at least one fluid line of the medical treatment device associated with the interior of the medical treatment device and a connector of a disposable fluid line that conducts fluid associated with the exterior of the medical treatment device, the rinse cap having a front / end surface that faces the interior of the medical treatment device when the rinse cap is in use, the front / end surface having an axially and / or radially raised edge on its circumference.
13. The medical procedure device of claim 12 , wherein the raised edge comprises a wedge-shaped or triangular portion in a longitudinal cross section of the rinse cap.
14. 14. The medical treatment device of claim 11, wherein the swivel lever includes a recess or groove for inserting a portion of an edge of an end plate or end disk of the connector to remove the connector from the port.
15. The medical treatment device according to any one of claims 10 to 14, wherein the port is received in the fastening portion so that the centerline of the first fluid guide or the first lumen is inclined by 4° or more with respect to a surface on which the medical treatment device is placed.
16. The medical treatment apparatus according to any one of claims 11 to 15, wherein the swivel lever comprises a displacement device that is translationally displaceable or guideable along the pivot axis.
17. 17. The medical treatment apparatus according to any one of claims 10 to 16, comprising a return element for translating the receiving part, and a damper device for damping the translation caused by the return element.
18. 18. A system having a disposable item comprising a medical treatment device according to any one of claims 10 to 17, the disposable item comprising a fluid line and a connector, the connector having a connector lumen for fluidly connecting the fluid line with the first lumen of the first fluid guide of the port.