Peritoneal dialysis system with light emitter

Abstract

The present invention relates to a system for medical treatment, preferably for dialysis treatment of a patient (P), in particular for treatment by peritoneal dialysis, comprising a base body, in particular an organizer (1), with connection points (11, 12, 13, 14) for a disposable and a light emitter (110) for emitting light, in particular for inactivating infectious pathogens. It further relates to a method for preparing or reprocessing a system according to the invention.

Description

[0001] The present invention relates to a system for medical treatment according to claim 1 and to a method according to claim 18 or according to the preamble or generic term of these claims.

[0002] Organizers for peritoneal dialysis are known from DE 10 2018 113 322.

[0003] One object of the present invention is to provide a further system for medical treatment. It has a base body, which can be an organizer.

[0004] The problem according to the invention is solved by a system having the features of claim 1 and a method having the features of claim 18.

[0005] The present invention relates to a system for medical treatment, preferably for dialysis treatment of a patient, in particular for treatment by peritoneal dialysis. The system comprises a base body, in particular an organizer with connection points for a disposable, and further a light emitter for emitting light, in particular for inactivating infectious agents.

[0006] Typical examples of a disposable item can be a dialysis catheter, a tube, a tubing system, a connector, or any disposable dialysis product for peritoneal dialysis (CAPD or APD).

[0007] The system discussed herein is the subject of the present invention and is therefore in accordance with the invention.

[0008] The present invention also relates to a method for preparing or processing the system for treatment by means of peritoneal dialysis, with an emission of light by means of the light emitter, in particular for inactivating infectious agents, onto a disposable when connected to the base body of the system, or onto a receptacle or connection point for connecting the base body to a disposable.

[0009] Reprocessing can take place during treatment, e.g. once or multiple times, e.g. at predetermined time intervals, or after a predetermined period of time, measured approximately from the start of treatment.

[0010] Preparation takes place before the start of treatment, e.g., while the system is not yet connected to the patient, especially not in fluid contact.

[0011] The method discussed herein is the subject of the present invention and is therefore in accordance with the invention. Inventory embodiments may, based on any one of the independent claims, include one or more of the features mentioned above or below. The features mentioned herein may be the subject of any combination of inventory embodiments based on any one of the independent claims, provided that a person skilled in the art does not recognize a specific combination as technically impossible.

[0012] In all the above and all subsequent statements, the use of the expression "may be" or "may have" etc. is to be understood as synonymous with "is preferably" or "has preferably" etc. and is intended to explain embodiments according to the invention.

[0013] Whenever numerical terms are used herein, a person skilled in the art understands them to indicate a lower numerical limit. Unless this leads to a contradiction apparent to a person skilled in the art, they will always interpret the use of "ein" or "einem" as meaning "at least one" or "at least one." This understanding is encompassed by the present invention, as is the interpretation that a numerical term such as "ein" can alternatively be meant as "exactly one," wherever this is technically feasible to a person skilled in the art. Both are encompassed by the present invention and apply to all numerical terms used herein.

[0014] Whenever spatial terms such as "above," "below," "left," or "right" are used herein, a person skilled in the art understands this to mean the arrangement shown in the attached figures and / or in the operating state. "Below" is closer to the Earth's center or the lower edge of the figure than "above."

[0015] Advantageous further developments of the present invention are each the subject of dependent claims and embodiments.

[0016] Whenever an embodiment is mentioned herein, it refers to an exemplary embodiment according to the invention, based on one of the independent claims, which is not to be understood as limiting.

[0017] If it is disclosed herein that the object of the invention has one or more features in a particular embodiment, it is also disclosed herein that the object of the invention expressly does not have precisely this or these features in other embodiments, which are also according to the invention, e.g., in the sense of a disclaimer. For each embodiment mentioned herein, the opposite embodiment, formulated, for example, as a negation, is therefore also disclosed.

[0018] Embodiments as disclosed herein further develop the invention as defined by the independent claims.

[0019] If process steps are mentioned herein, the optional control device of the system is configured in some embodiments to execute one, several or all of these process steps, particularly if these are automatically executable steps, in any combination or to control corresponding devices, which preferably are named according to the designation of the respective process step (e.g. 'Determine' as a process step and 'Device for Determining' for the device, etc.) and which may also be part of the device(s) according to the invention or be connected to it by signal connection.

[0020] When the terms "programmed" or "configured" are used herein, these terms may be interchangeable in some embodiments.

[0021] When "biomarkers" are mentioned here, they can include, for example, urea, creatinine, β2-microglobulin, various proteins, and / or other carbon-containing substances. Biomarkers can include exploratory biomarkers, such as soluble CD59 (for assessing peritoneal membrane function), fibroblast growth factor 23 (FGF23, as a biomarker for inflammation), interleukin-6, matrix metalloproteinase 8, and neutrophil gelatinase-associated lipocalin (NGAL), for example, as a biomarker for detecting peritonitis.

[0022] When this text refers to a signal or communication connection between two components, it can mean a connection that is already in use. It can also mean that preparations are underway for such a signal connection (wired, wireless, or implemented in any other way), for example, by coupling the two components, such as through pairing, etc.

[0023] Pairing is a process used in computer networks to establish an initial connection between computer units for communication purposes. The most well-known example is establishing a Bluetooth connection, which allows different devices (e.g., smartphones, headphones) to connect to each other. Pairing is sometimes also referred to as bonding.

[0024] Where procedural steps are mentioned herein, in some embodiments it is provided that these take place before or after treatment of the patient, for example while the patient is not connected to the device, e.g. by means of the third (patient) line or the like, or that treatment has not yet started or has already ended.

[0025] The control device can initiate the execution of all or substantially all process steps. The method according to the invention can be carried out substantially or completely by the control device. It can be carried out partially by the control device; in particular, those steps that do not require or involve human intervention and / or provision can be carried out by the control device. The control device can serve as a pure control device or also as a regulating device.

[0026] In some embodiments of the system according to the invention, it includes a control device (here also referred to as: control unit) which is configured to cause the light emitter to emit light. The control device can be programmed accordingly. It can also be programmed with respect to when light is to be emitted by means of the light emitter. A switch, e.g., which is necessarily actuated when the disposable is inserted into, for example, a connection point, can, for example, be a trigger for the control device to act on the light emitter, for instance, immediately upon actuation of the switch, after a predetermined duration, etc.

[0027] In some embodiments, the system includes a lens which is arranged to focus light emitted by the light emitter.

[0028] In some embodiments, the lens is arranged to focus the light towards the recording or the disposable.

[0029] In some embodiments, the light emitter is configured to emit light at variable wavelengths.

[0030] In some embodiments, the system includes an optical sensor designed to detect light emitted by the light emitter and subsequently reflected or scattered. This sensor can, for example, be configured as a color sensor.

[0031] In certain embodiments, the system additionally or alternatively includes at least one capacitive sensor and / or at least one Hall sensor.

[0032] The aforementioned sensors may be arranged on a multi-sensor block, on a hose assembly or system and / or on a measuring chamber, as disclosed herein.

[0033] In some embodiments, the light emitter is configured to emit light at hygienically effective intensity and / or wavelengths.

[0034] In some embodiments, the light emitter is arranged to emit light in the direction of the receiver or a disposable receiver therein.

[0035] In some embodiments, the control or regulating device is configured to control and / or monitor treatment of the patient, or parts thereof.

[0036] This can be achieved, for example, by selectively controlling pumps, sensors, valves, the light emitter and / or other components of the system.

[0037] In some embodiments, the control or regulating device is configured to cause the emission of light during a specific time or duration which falls within the treatment of the patient.

[0038] In some embodiments, the control device is configured to cause the emission of light by means of the light emitter in order to determine therapy-relevant parameters. In certain embodiments, this emission occurs during the patient's treatment.

[0039] Such parameters include, for example, the burden of pathogens (bacteria, viruses, etc.) and / or the concentration of glucose, electrolytes, proteins, biomarkers or blood cells.

[0040] In some configurations, measuring the reflection or scattering of emitted light using a sensor can not only detect pathogens but also optionally enable their identification. The concentration of glucose, electrolytes, proteins, biomarkers, or blood cells can be measured using any turbidity detected. Alternatively or additionally, blood cells can potentially be classified by measuring the scattering of light.

[0041] In some embodiments, the light emitter is configured to emit light for disinfecting surfaces.

[0042] In some embodiments, the light emitter can emit radiation from the part of the electromagnetic spectrum that is not visible to humans.

[0043] In some embodiments, the light emitter is configured to inactivate or attenuate infectious material, especially bacteria, fungi, spores and / or viruses.

[0044] In some embodiments, the light emitter preferably comprises at least one LED and / or a laser, which is designed to emit infrared (IR), ultraviolet (UV), and non-ultraviolet (non-UV) visible electromagnetic radiation (EMR). Preferably, light or electromagnetic radiation is emitted at wavelengths of 270 nm, 365 nm, 385 nm, and 405 nm, at energies between 0.1 kJ / cm². 2 and 1 kJ / cm 2 and 0.005 mW and 1 watt.

[0045] In some embodiments, the light emitter is an EMR transmitter, comprising, for example, an LED and / or a laser, a refractive lens, the associated electronic components and wiring, and a shaping element, e.g., a frame. The LED(s) can emit electromagnetic radiation according to their inherent scattering properties or may employ other optical elements for this purpose. Such optical elements may be or include lenses, mirrors, filters, or the like, each suitable and / or designed to focus or scatter the electromagnetic radiation in a desired direction.

[0046] In some embodiments, several LEDs are arranged, for example in a row, to emit one of the aforementioned radiations, e.g. electromagnetic radiation.

[0047] In some embodiments, the radiation, in particular electromagnetic radiation, is guided to its site of action, e.g., a catheter, the organizer around the catheter, the disposable, in particular the tube seat or tube connection, the connector, or a fluid bag, by means of an elongated tubular or solid body (for example, by means of an optical waveguide or fiber optic cable). The tubular or solid body can be filled with a gas, e.g., air, a liquid, e.g., an aqueous solution, a light-conducting polymer or glass, or it can contain a vacuum.

[0048] The material of the system according to the invention preferably enables the conduction of disinfecting or diagnostic radiation, in particular EMR, to or into the disposable, for example by means of certain light-conducting materials, such as polymers or glass.

[0049] Since the first connector section, the patient connector and / or the sealing pin, also referred to individually or collectively as the distal catheter inlet, poses an increased risk of contamination with infectious agents that could cause a patient infection, the light emitter is arranged to direct the radiation, e.g., electromagnetic radiation, preferably directly or indirectly onto its surface, for example, the surface of the sealing pin. This can occur directly or via reflection of the light, for example, from the tubing wall or by means of a light-conducting component. Such a component can, for example, be made of a polymer which, in some embodiments, may also contain partially reflective particles. Such a component can be provided to further diffuse the light and irradiate larger areas around the catheter inlet with disinfecting radiation, in particular electromagnetic radiation.

[0050] Alternatively or additionally, the light emitter is arranged to irradiate an inner wall of the system according to the invention, in particular the inner wall of the disposable and / or the gas located there before the treatment of the patient (e.g. air before the start of the fluid exchange) and / or the liquid located there during the treatment of the patient (e.g. dialysis fluid or effluent) by means of the radiation, in particular the electromagnetic radiation.

[0051] In some embodiments, the control or regulating device is configured to emit light with at least one wavelength of electromagnetic radiation selected from a group of wavelengths as its principal wavelength in order to disinfect the target location of the emitted light, e.g. the disposable or a section thereof, from one or more target organisms or pathogens.

[0052] In some embodiments, the control device is configured to change the principal wavelength of the light emitted by the light emitter between a first principal wavelength and a second principal wavelength that differs from the first principal wavelength. In certain embodiments, such a change can follow a selected or predetermined pattern.

[0053] In some embodiments, the control device is configured to cause the light emitter to transmit the electromagnetic radiation in pulses in order to improve the elimination of pathogens. The pulse width modulation is preferably at a frequency of 100 Hz to 10 kHz, and most preferably at 1000 Hz.

[0054] This can result in energy savings of up to 35%, especially for a 30%-50% duty cycle. In other words, the light is emitted 30% to 50% of the time and not 70% to 50% of the time.

[0055] The light emitter (as always herein, unless otherwise specified: at least one) can be provided and / or configured to emit several wavelengths simultaneously, one after the other, in parallel, or as a combination thereof. A combination could, for example, consist of a constant and a pulsed wavelength. Different intensities can also be emitted simultaneously by the single light emitter. Different patterns of light emission are also encompassed by the present invention.

[0056] This light of different wavelengths, emitted axially or radially into the system according to the invention by the light emitter, can be used for light-based diagnostics by determining (patient) parameters relating to the dialysis fluid or effluent, such as its turbidity. In this case, an optical sensor, which is positioned near or at an angle to the light emitter, measures the absorption of reflected, visible and / or invisible radiation, e.g., UV radiation, or of reflected infrared light.

[0057] In some embodiments, the optical sensor, or one of them, is arranged on a tubular or filled cylindrical body, for example on the tube wall of the disposable (catheter, tube, connector or bag), e.g., the measuring chamber, for example as part of the organizer, and can detect scattered or refracted light at this point. The material of the system according to the invention preferably enables the conduction and transmission of diagnostic electromagnetic radiation to the sensor.

[0058] The optical sensor is preferably capable of generating diagnostic information from reflected light passing through the system and the relevant liquids in two directions. This can be achieved by detecting, for example, color, scattering at obstacles, light intensity, absorption, the transmission of light of different wavelengths, the flow rate (in and out) within the disposable, etc. Observed turbidity, for instance, can be an indication of infection. In this way, glucose, electrolyte, or biomarker concentrations and / or blood cell types can be determined, and / or infectious agents (e.g., bacteria, fungi, viruses) as well as their concentration and classification can be identified.

[0059] In some embodiments, the light emitter is arranged to emit hygienically effective light in the direction of a sealing pin or outlet pin of the system, preferably the disposable.

[0060] The control or regulating device can cause all or almost all process steps to be carried out.

[0061] Whenever the term "pipe" is used herein, these pipes are suitable and / or intended to convey fluids or liquids.

[0062] Whenever the term "automatic hose clamp" is used herein, it may include automated hose clamps, electromagnetic hose clamps and / or the like.

[0063] Whenever the term "sealing pin" is used herein, it may be a synonym for "safety pin" or "locking pin". In some embodiments, these terms may be interchangeable.

[0064] The “third line” can also include a “patient line”, which in some embodiments may be implemented as a catheter extension.

[0065] The terms “sensor”, “reader”, “reader” and / or “scanner” may be interchangeable in some embodiments.

[0066] In certain embodiments, the system includes a dialysis fluid source or bag and / or a drain or collection bag. In other embodiments, this is not the case.

[0067] In some embodiments, the system according to the invention includes or is connected to a power source, for example a battery, rechargeable battery, accumulator or the like.

[0068] In some embodiments, the base body or first reusable unit (hereinafter also referred to as the base body) is a tray or a tray-shaped or tray-like body, or comprises one. Optionally, the base body does not include any lines for conveying fluids to or from the patient, as long as it is not connected to the disposable.

[0069] In some embodiments, the base body includes or is connected to the disposable. The disposable can be connected to the base body via the first connection point and / or vice versa.

[0070] For this purpose, the first connection point can be or comprise at least one receiving device, for example a groove and / or a clamping section. This applies to each connection point provided on the base body. Furthermore, any suitable number of connection points on or at the base body are encompassed by the present invention.

[0071] In some embodiments, the disposable comprises a first line for conveying fresh dialysis fluid from a dialysis fluid source or bag (which are optionally also included in the system) and a second line for conveying used dialysis fluid, hereinafter also referred to as dialysate, to or into a drain or collection bag (which are optionally also included in the system). Both lines are connected to each other, i.e., in fluid communication, preferably via a Y-piece, a connector, or another line segment. The Y-piece or other line segment is in fluid communication with a third line, through which or along which fresh dialysis fluid is conveyed from or through the organizer or the disposable to the patient, and used dialysis fluid is conveyed from the patient to or through the organizer or the disposable.

[0072] In some embodiments, the disposable comprises a first line for conveying fresh dialysis fluid from a dialysis fluid source or bag to the organizer, or its base body, and for conveying used dialysis fluid away from the organizer, or its base body, to a drain or a collection bag, and further a third line which is in fluid communication with or connected to the first line.

[0073] In some embodiments, the first line includes a hose clamp, in particular a manual one.

[0074] In some embodiments, the second line includes a hose clamp, in particular a manual one.

[0075] In some embodiments, the third line includes a patient hose clamp, in particular a manual one.

[0076] In some embodiments, the Y-piece or the third line includes or is configured as a measuring chamber or measuring section. The measuring chamber or section may differ from adjacent sections in structure, light transmission, wall thickness, and / or the like.

[0077] In some embodiments, the Y-piece, the third line, and / or the measuring chamber includes a boundary or rim for user handling. This boundary or rim can be designed as a protrusion that prevents the disposable from slipping through the user's fingers during system setup. This protects the measuring chamber or section from unintentional contact or contamination by the user (keyword: "touch contamination"). This helps ensure the correctness and accuracy of future measurements.

[0078] In some embodiments, the third line, which may include or be extended by means of a patient line and may further comprise a patient line connector (hereinafter referred to as "patient connector") for optionally connecting the patient line to other sections of the third line, for example, the measuring chamber or section, may have a connection point or coupling point, preferably a screw connection. This connection point or coupling point may serve to connect sections of the third line to a sealing pin, which may itself also be part of or encompassed by the third line. The connection point may be the patient line connector or a section thereof, if provided.

[0079] In some embodiments, a section of the third line, which is connected to the optional Y-piece, the measuring chamber or section, or any other section of the third line, has a first connector section, while the patient connector has a second connector section. The first and second connector sections can fit together or complement each other, for example, as a threaded connection and screw, preferably to create a fluid-tight connection. Both connector sections provide a lumen through which fluid can pass. Both connector sections can be arranged to be connected to the sealing pin mentioned herein. Both connector sections can be arranged to form a common lumen in which the sealing pin mentioned herein is or is inserted.

[0080] In some embodiments, the sealing pin, or a part thereof, has a lumen through which fluid can flow along the sealing pin. The sealing pin can be located, at least partially, in the lumen of the first connector section, the second connector section, or in the common lumen, so that fluid can flow through and / or along the sealing pin, thus forming a channel leading from the first connector section to a channel connected to the second connector section, or vice versa.

[0081] In some embodiments, the sealing pin has a threaded section on its outside which is suitable for engaging with the first connector section, the first connector section in turn having a threaded section on its inside.

[0082] In some embodiments, the sealing pin further comprises a first limiting element. The first limiting element can be an element that restricts the movement of the sealing pin relative to the second connector section, or it can be part of a mechanism for this purpose. The first limiting element can be a rim or preferably have the form of teeth, a toothed block, projections, or the like, which restricts rotation of the sealing pin in at least one direction of rotation when it is in contact with a second limiting element or another section of the second connector section that is suitable for engaging with the first limiting element.

[0083] In some embodiments, the sealing pin has a fastening element on or at its end opposite the first limiting element, by means of which the sealing pin can be detachably or non-detachably attached to a closure element, preferably by means of a snap connection and / or by means of an undercut, for example such as a sealing cap or disinfection cap.

[0084] In some embodiments, the second connector section has a receiving section which preferably concentrically surrounds the lumen of the second connector section for receiving a first threaded section on the outside of the first connector section, wherein the receiving section of the second connector section has a threaded section on its inside which is suitable to engage with the first threaded section of the first connecting section.

[0085] In some embodiments, a second limiting element is arranged on the inner side of the lumen of the second connector section. This element preferably has the form of a toothed block and is suitable for cooperating with the corresponding first limiting element of the sealing pin to limit the rotation of the sealing pin in at least one direction of rotation.

[0086] In some embodiments, the second limiting element is designed in the form of a plurality of ribs which extend axially along the inside of the second connector section and / or as grooves in or on an inner surface of the second connector section.

[0087] In certain embodiments, the first and second limiting elements form part of a mechanism for preventing or limiting rotation. Obviously, they represent only one example of such a mechanism, which is included in several embodiments.

[0088] In some embodiments, the sealing pin is arranged in a common lumen, which is formed by means of the lumens of the first and second connector sections, wherein the sealing pin is movable in a relative movement of the first connector section to the second connector section between an open position, in which the sealing pin allows a fluid flow through the common lumen, and a closed position, in which the sealing pin prevents the fluid flow through the common lumen.

[0089] In some embodiments, the third line is connected to or encompasses the patient connector.

[0090] In certain embodiments, the patient connector is the second connector section or includes it.

[0091] In some embodiments, the third line includes a self-injecting and / or self-sealing mechanism to seal the patient connector when it is disconnected.

[0092] In some embodiments, the sealing pin as described herein may be the self-injecting and / or self-sealing mechanism or a part thereof.

[0093] In certain embodiments, the self-injecting and / or self-sealing mechanism is designed as disclosed in WO 2021 / 043737 A1, the corresponding disclosure of which is incorporated herein by reference.

[0094] In some embodiments, the self-injecting and / or self-sealing mechanism is or comprises the first connector section, which has a lumen for guiding fluid; the first threaded section, which is arranged on an outside of the first connector section and which enables a releasable connection of the first connector section with the correspondingly matching second connector section; and a second threaded section, which is arranged on an inside or on the lumen side of the first connector section and which enables a releasable connection of the first connector section with the correspondingly matching sealing pin, wherein the thread pitch of the first threaded section preferably differs from the thread pitch of the second threaded section.

[0095] In some embodiments, the patient connector includes a border or rim for easier handling.

[0096] In some embodiments, the first line, the second line, and / or the third line (each) include an automatic hose clamp, or the system provides an automatic hose clamp for the first line, the second line, and / or the third line. The hose clamps can be controlled by or from the system's control or regulating device.

[0097] In some embodiments, the system includes at least one signaling device to indicate the status of the automatic hose clamps, in particular whether they are open or closed.

[0098] In some embodiments, at least one signaling device is designed as an LED.

[0099] In certain embodiments, the at least one signaling device can change its color to indicate the status of the hose clamp, for example, red for closed, green for open. Other light signals, for example, flashing, on / off, etc., may also be included in the present invention.

[0100] In some embodiments, the first line includes a breaking or predetermined breaking device, or the system provides a breaking or predetermined breaking device for any one of the first, second or third lines, in particular for the first line.

[0101] To allow the breakaway or predetermined breaking device to be easily broken, and thus enable fluid flow, the base body or the first reusable unit can include a kink assist. Alternatively, the hose dimensions of the line are selected such that a breakable edge of the breakaway or predetermined breaking device is located near an edge, opening, projection, ledge, or similar feature of the organizer, where an edge allows the hose to break when bent over it.

[0102] In some embodiments, the base body or the first reusable unit has at least a fifth connection point for connecting a used or unused disinfection cap or sealing cap to the base body or the first reusable unit. The disinfection cap or sealing cap can be the aforementioned closure element.

[0103] In some embodiments, the fifth connection point may be or comprise at least one fifth receiving device.

[0104] In some embodiments, the system or organizer includes a disinfection cap or sealing cap.

[0105] In some embodiments, the system or organizer includes a control device, which comprises a microprocessor, a CPU, or other processing unit. The control device may be used to execute and / or control some or all of the automated functions of the system.

[0106] Automated functions can be understood as some or all functions that do not involve human intervention or input from a user. In this context, the control device can automatically execute a program, algorithm, or similar, and is capable of making decisions based on it and controlling the intended procedures as needed. Examples of automated functions include initiating measurements, actuating automatic hose clamps, automatic data acquisition, data transmission, and the like.

[0107] In some embodiments, the control device is configured to control the actuation of the automatic hose clamps. In some embodiments, the system includes a flow sensor for measuring liquid flows and / or at least one, preferably electronic, scale for measuring weight. The flow sensor is preferably arranged on the base body or on the first reusable unit.

[0108] In some embodiments, the control or regulating device is configured to control the actuation of the automatic hose clamps with respect to time and / or volume, preferably based on measured values ​​from the flow sensor, electronic scale, optical sensor and / or another sensor, for example, as described herein.

[0109] In certain embodiments, the control device automatically detects the presence of a disposable item and / or only functions with a correctly inserted disposable item. Corresponding sensors, probes, or other devices may be provided. These may communicate with the control device via signals.

[0110] In some embodiments, the control or regulating device is configured to keep the automatic hose clamp on the third line and the automatic hose clamp on the second line open for drainage, particularly initial drainage, after connecting the patient until no more flow—or no change in weight if a scale is used alternatively—or no significant fluid flow or weight change is recorded within a predetermined period of time and / or the drainage of fluid from the patient's abdominal cavity is considered complete.

[0111] Regarding the use of the term "initial drain": When a new ADP treatment is started, it is important to remove any fluid that may have accumulated in the abdominal cavity by means of initial draining before the first filling cycle is performed. With the drain clamp opened beforehand, drainage can start spontaneously and immediately as soon as the patient is connected to the third line of the disposable catheter, without any further action being required.

[0112] In some embodiments, the control or regulating device is configured to cause a draining, flushing, filling, dwelling and / or (re-)draining into, through or out of the first line, second line and / or third line.

[0113] In some embodiments, the electronic scale of the system is preferably provided in such a way that it supports wireless communication with other sections of the organizer, in particular with the control or regulating device.

[0114] In some embodiments, the control or regulating device is configured to cause air to be removed from the first line.

[0115] This can be done by means of dialysis fluid flowing downwards from a bag of fluid when it is connected or becomes connected to the first line, and towards a collection bag connected to the second line while one of the hose clamps of the third line is kept closed, and by opening the hose clamps of the first and second lines or by keeping them open for a reasonable period of time.

[0116] In some embodiments, the control device is configured to allow a flow of fresh dialysis fluid along the first and third lines into the abdominal cavity for therapeutic purposes. This is achieved by keeping the automatic clamp of the second line closed and by keeping the automatic clamps of the first and third lines open until a prescribed volume of fluid has been infused.

[0117] In some embodiments, the control or regulating device is configured to keep all automatic hose clamps closed during a prescribed therapeutic dwell time.

[0118] In some embodiments, the control or regulating device is configured to keep the automatic hose clamp of the second line, hereinafter also referred to as the drain line, and the automatic hose clamp of the third line open during the drainage of the dialysate from the abdominal cavity, while monitoring the weight of one or more of the bags used until no further flow or weight change (or no significant fluid flow or weight change) is recorded during a certain period of time and / or when the drainage of the fluid for this cycle is considered to be complete.

[0119] In some embodiments, the control device is configured to determine the fluid volumes draining from and / or infused into the patient. This can be achieved either by timely integration of values ​​measured by a coupled flow sensor, for example at the measuring chamber or section, or by monitoring an optional balance that registers the differential weight change of fresh dialysis fluid or drained dialysate.

[0120] In these embodiments, the difference between the outflowed (flushed) and infused volume, or the change in total weight, represents the ultrafiltration achieved or even the absorbed fluid.

[0121] In some embodiments, the control device is configured to acquire specific measurements of a bidirectional flow, i.e., both during the infusion of fresh dialysis fluid into the patient's abdominal cavity and during the drainage of dialysate from the abdominal cavity. Preferably, the same sensor is used for both measurements (in and out).

[0122] In some embodiments, the system comprises one or more sensors for measuring, for example, glucose concentration, other biomarkers, turbidity, temperature, and / or conductivity. Preferably, the sensors are coupled to or arranged on the measuring chamber or section. These sensors can be used to acquire diagnostic data for therapy efficiency and improvement, preferably in both directions on the same measuring chamber or section, i.e., to provide data from both the inflowing fresh dialysis fluid and the outflowing dialysate.

[0123] In some embodiments, the control device is configured to automatically check the fluid flowing from the abdominal cavity for increased opacity using a turbidity sensor coupled to the measuring chamber or system, thus advantageously increasing patient safety. Increased opacity can indicate the presence of white blood cells or an elevated protein concentration, and therefore a potential infection (peritonitis).

[0124] In some embodiments, the control device is configured to calibrate the turbidity sensor and / or other optical sensors during the infusion of fresh dialysis fluid along the first line.

[0125] In some embodiments, the control or regulating device is configured to monitor or continuously monitor, by means of the temperature sensor, the temperature of the fresh dialysis fluid flowing in along the first line and / or the temperature of the dialysate flowing out along the second line.

[0126] In these embodiments, the measured values ​​(hereinafter also referred to as measured values) can be used to correct all other temperature-dependent values. Furthermore, the temperature sensor can be used to monitor and control the temperature of the incoming fluid and to stop the flow should the measured temperatures fall outside permissible safety limits. The temperature sensor coupled to the measuring chamber or section can also measure the patient's core body temperature in the outgoing fluid and detect an elevated temperature or fever, which may indicate a potential infection. Alone (for example, in a bidirectional measurement) or in combination with the results of the turbidity measurement, this can indicate peritonitis.

[0127] In some embodiments, the control or regulating device is configured to measure, by means of the glucose sensor, the corresponding glucose concentration of the fresh dialysis fluid, which e.g. comes from a bag, a mixture of bags or is prepared on site, during the inflow along the first line and / or of the dialysate during the outflow along the third line, alternatively along the second or third line.

[0128] This value can then be compared with the prescribed glucose concentration, allowing adherence to the therapy plan to be monitored and confirmed. An alarm can be triggered in case of significant discrepancies.

[0129] Furthermore, the glucose concentration resulting from a mixture of bags with different glucose contents can be monitored and controlled, and used for therapy-relevant calculations. This baseline measurement can then be compared with the glucose concentration of the outflowing dialysate. This provides further therapy-relevant information to determine the suitability of the therapy and the amount of fluid removed. The glucose meter can be helpful when setting up automated routine tests to check the function of the peritoneal membrane (peritoneum) and can enable precise PD therapy.

[0130] In some embodiments, the control or regulating device is configured to measure the respective conductivity of the fresh dialysis fluid, e.g. fluid from a bag, a mixture of bags or prepared on site, by means of the conductivity sensor, particularly in the first or third line.

[0131] This baseline measurement is then compared with the conductivity of the outflowing dialysate. This provides therapy-relevant information regarding the suitability of the therapy and the performance of the peritoneum, which advantageously enables precise PD therapy.

[0132] In some embodiments, the control or regulating device is configured to determine, prior to connecting the patient, by means of at least one of the knives or sensors mentioned herein, for example the turbidity sensor, or by means of a combination of these sensors, when the initial priming of the disposable and / or the third line (which preferably includes the patient line) is complete and all air has been removed from the lines.

[0133] In some embodiments, the appropriate actuation of the automatic hose clamp of the second line ensures an air-free filling of the system and ultimately a termination of the filling process.

[0134] In some embodiments, the system includes a barcode scanner, QR code scanner, and / or RFID scanner. These types of sensors can be capable of reading a variety of information, such as the type of product, concentrations, an article number, a serial number, an expiration date, and / or the like.

[0135] This information, in the form of a matrix (2D) barcode or RFID, which is attached or printed on the side of the measuring chamber or section, can enable checks relating to therapy compliance and provide product-related information, for example for documentation of the therapy.

[0136] In some embodiments, the system includes a pressure gauge to measure the hydrostatic pressure within the patient's abdominal cavity, called intraperitoneal pressure (IPP).

[0137] Such a pressure gauge can be positioned in a shaft-like structure within the main body or the first reusable unit, next to the third connection point for the third line. It can then measure the pressure within the third line very precisely and without external influences, corresponding to the IPP (Intermittent Pressure Point), provided the automatic clamp of the third line is closed. Furthermore, the pressure within the connected bags (for dialysis fluid and dialysate) can also be determined very precisely and without external influences when the manual clamp of the third line is closed towards the patient and the corresponding clamps of the first and second lines are opened. Opening and closing the automatic clamp ensures that only pressure values ​​reflecting the pressure in the patient's abdominal cavity are measured.

[0138] In some embodiments, the control or regulating device is configured to close or keep closed the automatic hose clamp of the third line while measuring the pressure prevailing in the patient's abdominal cavity.

[0139] In some embodiments, the control device is configured to initiate pressure measurements during the inflow, residence, or outflow of the dialysis fluid and to evaluate the measured values ​​thus obtained. It can remain open whether changes in the measured values ​​during the inflow, residence, or outflow of the dialysis fluid are measured, or when these values ​​are determined.

[0140] In some embodiments, the control or regulating device is configured to automatically calibrate the pressure gauge, e.g., at periodic intervals. This can be achieved by a method in which the dialysis fluid bags are positioned or fixed at a specific predefined height, the automatic hose clamp of the second line and the automatic hose clamp of the third, patient-facing line are closed, and the automatic hose clamp of the first line and / or the automatic hose clamp of the third line are opened to measure the hydrostatic reference pressure.

[0141] In some embodiments, one, some, or all of the sensors are automatically calibrated or checked before each treatment, preferably by means of the control device, preferably in a separate process and / or during the filling process, in which standard ACPD or ADP solution is used, flowing along the sensors or the at least one multisensor block. This is done to advantageously define individual start or reference values ​​in a simple manner, particularly based on fresh dialysis fluid.

[0142] In some embodiments, the system comprises a multi-sensor block which in turn comprises some or all of the system's knives or sensors described herein.

[0143] In some embodiments, the control or regulating device or another component of the system or organizer includes an external communication device, preferably to act as a data gateway.

[0144] Secure and efficient communication between the organizer (its main body, other external devices, such as the battery-operated digital scale, a heating device, a blood pressure monitor, etc.) and the external communication device can be established or managed, for example, via a dedicated application (app), such as part of a holistic patient application or a device-specific application.

[0145] If the external communication device acts as a data gateway, it can provide all modern / current security and data protection measures that modern smartphones, tablets, or the like offer.

[0146] In some embodiments, the external communication device is used for user and / or patient identification and data assignment. This can preferably be achieved using biometric recognition, such as face ID or a fingerprint sensor, or a personalized code, or a combination of these methods, utilizing established external communication devices such as smartphones, tablets, or the like. In some embodiments, the control device can be configured to send status information to the external communication device, such as terminal open or closed, battery charge level, error codes, timestamps, etc., as well as measurement results from some or all of the system's meters or sensors.

[0147] In some embodiments, the organizer supports wireless bidirectional communication, e.g. via Bluetooth, Wi-Fi or others, to establish or maintain a signal connection with the independent external communication device, such as the patient's smartphone, a tablet or the like.

[0148] When this text refers to a signal or communication connection between two components, it can mean an existing connection. It can also mean that preparations are underway for such a (wired, wireless, or otherwise implemented) signal connection, for example, by coupling the two components, such as through pairing. Pairing is a process used in computer networks to establish an initial connection between computer units for communication purposes. The most well-known example is establishing a Bluetooth connection, which allows various devices (e.g., smartphones, headphones) to connect. Pairing is sometimes also referred to as bonding.

[0149] In some embodiments, the external communication device, which in turn is in signal communication with a secure data cloud, can receive and process some or all of the data and / or information mentioned herein. Cloud computing (special algorithms) known from the prior art can be used for this purpose.

[0150] In some embodiments, the external communication unit can be configured to display data and / or information, such as the results of its processing as described herein. Alternatively or additionally, it can be configured to send commands to the automated organizer to open and close terminals and / or to initiate specific preparation, treatment, measurement, or calibration actions, or status changes. These actions advantageously allow the entire therapy or treatment to be digitized, documented, stored, analyzed, and / or controlled.

[0151] In some embodiments, the external communication device is configured to act as a remote control for the organizer and wirelessly connected accessories and / or represents the central display of the system, i.e., where all potential user interface interactions take place.

[0152] In other embodiments, however, the organizer is capable of functioning autonomously and is not necessarily dependent on a wireless connection to, or the presence of, the external communication device. All measured or generated data can be temporarily stored in or on the organizer, for example, in or on a suitable and designated storage device. This data can then be transferred to the external communication device and subsequently to the cloud whenever a connection is available. In some embodiments, this transfer can occur in both directions.

[0153] In some embodiments, the system includes a camera.

[0154] In some embodiments, the system includes a heating device, in particular a heating plate, for heating or tempering the dialysis fluid source or the bag. A power supply for this purpose may be provided and included in the system.

[0155] In some embodiments, the heating device includes a communication device to communicate with, for example, the organizer and / or the external communication device, or corresponding sections thereof.

[0156] In some embodiments, the heating device includes a container or a vessel, in particular a foldable one.

[0157] In some embodiments, the heating device, or a container or a vessel thereof, includes an insulating cover.

[0158] In some embodiments, the organizer has a soft shape, preferably a teardrop shape without protruding and / or sharp edges, to provide increased comfort during use.

[0159] In certain embodiments, the control or regulating device is not configured to estimate particle concentrations and / or leukocyte concentrations, for example based on measurements that have been or are being performed by the provided knives or sensors.

[0160] In some embodiments, the base body or the first reusable unit and / or the disposable do not include an additional fluid line or fluid bypass line for conveying fluid from one of the components to the sensors provided herein or along the line / bypass line. This can apply in particular to any type of gauge or sensor disclosed herein, optionally with the exception of the pressure gauge. The pressure gauge can be connected to the base body or the first reusable unit or the disposable by means of a separate line / bypass line.

[0161] In certain embodiments, the system does not include a substance for calibrating the knives or sensors.

[0162] In some embodiments, urea is not measured and / or no percentage is calculated based on detected urea by means of the control or regulating device or any other element of the system.

[0163] In certain embodiments, no dial and / or other element, such as a connector, for example a so-called "stay safe" connector (which is part or disc of an organizer and is commercially distributed by Fresenius Medical Care, Germany, compare its disclosure in WO 2013 / 159935 A1, to which reference is hereby made), which must be inserted into or connected to the base body or the first reusable unit, is required to use the system and / or is not included therein.

[0164] Some or all embodiments of the invention may have one, several or all of the advantages mentioned above and / or below.

[0165] An advantage of the present invention may be that the disinfection of single-use components, or sections thereof, can significantly reduce the risk of contamination and thus also the risk of peritonitis associated with peritoneal dialysis. This contributes to a significant increase in patient safety.

[0166] A further advantage of the present invention may be that the light emitter can also be used for diagnostic measurements. The results obtained from these diagnostic measurements can be used to improve the quality and effectiveness of peritoneal dialysis and thus also well-being and health, among other things by triggering early adjustments to the therapeutic prescription and / or medication following such diagnostics.

[0167] The use of ultraviolet visible or invisible – or non-ultraviolet visible or invisible – electromagnetic radiation (EMR) of sufficient intensity can reduce or eliminate infectious agents (e.g., bacteria, fungi, viruses) directly before, during, or after a peritoneal dialysis treatment session, which can last up to 12 hours. This can represent a further benefit.

[0168] All the advantages achievable with the system according to the invention can also be achieved without diminishing quality in certain embodiments of the invention using the method according to the invention, and vice versa.

[0169] The present invention is described below by way of example only, with reference to the accompanying figures. In these figures, identical reference numerals denote identical or similar components. The following applies: Fig. Figure 1 shows a system according to the invention in an exemplary embodiment; Fig. Figure 2 shows a disposable for connection with a system according to the invention in an exemplary embodiment; Fig. Figure 3 shows a second disposable for connection with a system according to the invention in a further exemplary embodiment; Fig. 4 shows the system according to the invention of Fig. 1 and the disposable of the Fig. 2 in a connected state; Fig. Figure 5 shows the system of the preceding figure in a sectional view from the side; and Fig. Figure 6 shows a system according to the invention in a highly simplified representation during the treatment of a patient.

[0170] Fig. Figure 1 shows a system according to the invention in an exemplary embodiment.

[0171] The system has a base body. This base body, here exemplified as a "first" reusable unit 10 of the organizer 1, is here exemplified as a housing 17 or as a tray, receptacle or storage for receiving a disposable 20 (see Fig. 2 or Fig. 3) designed. In some embodiments, the Disposable 20 can also be, as designated herein, a “second” (disposable) unit of the Organizer 1. Any other embodiment of the system, the base body, or the Organizer is also encompassed by the present invention.

[0172] The housing 17 is preferably made of hard, preferably disinfectable material or comprises exactly or at least one such material.

[0173] As explained above, the first reusable unit 10 can be provided to be connected to the disposable unit 20 (see Fig. 2 and Fig. 4).

[0174] In the example of the Fig. 1 The first reusable unit 10 optionally comprises five connection points 11, 12, 13, 14, 15 for this purpose (more or fewer connection points are also included in the present invention). Here, the connection points are exemplary configured as grooves or include grooves.

[0175] At this point, reference should be made to the descriptions of the following figures in order to avoid repetition.

[0176] In the example of the Fig. 1 include any of the - each optional - first connection point 11, second connection point 12 and / or third connection point 13 an optional, automatic hose clamp 40b, 50b or 60b, the purpose of which in connection with Fig. 4 is explained.

[0177] Preferably located in or on the housing 17, the system includes a light emitter 110 for emitting light. This light is particularly intended and / or suitable for inactivating infectious agents.

[0178] The main body, in particular its organizer 1 or first reusable unit 10, or any other section of the system, may further comprise a control device 100, which in turn may include a microprocessor or a CPU. The control device 100 may be configured or programmed to perform and / or control some or all of the automated functions, measurements, data acquisitions, and / or data transmissions. Preferably, the control device 100 is surrounded by or contained within the housing 17.

[0179] The control or regulating device 100 of the system is preferably provided and / or configured to cause the light emitter 110 to emit light.

[0180] The control device 100 can optionally be configured to cause the light emitter 110 to emit light at a variable wavelength. The light emitter can be provided and / or configured for this purpose, and in particular, made to do so.

[0181] The control device 100 can optionally be configured to cause the light emitter 110 to emit light at a hygienically effective intensity and / or wavelengths. The light emitter 110 can be provided and / or configured for this purpose.

[0182] Furthermore, the system in the example of Fig. 1, as in other embodiments, an optional lens 111 is provided, which is arranged to focus light emitted by the light emitter 110.

[0183] In the example of the Fig. 1 The system optionally includes, as in other embodiments, one or more, here three, optical sensors 113. These are arranged to detect light emitted by the light emitter 110 and subsequently reflected or scattered, for example, by a surface. The number and position of the optical sensors in the Fig. Figure 1 is purely exemplary and not to be understood as limiting. Any other number and / or arrangement of optical sensors is also encompassed by the present invention.

[0184] An optional signaling device 80, e.g., an LED, is arranged next to some or all of the automatic hose clamps 40b, 50b, 60b. The signaling devices 80 optionally serve to indicate the status of the automatic hose clamps 40b, 50b, 60b. This will also be described in more detail in Fig. 4 described.

[0185] The optional fourth connection point 14 may be provided and / or suitable to accommodate a line, hereinafter referred to as the third line 60, preferably a measuring chamber 55 or a section thereof, which during the treatment of a patient P (in Fig. (1 not shown) with a patient line 65 ( Fig. 2 and Fig. 3) can be connected. The lines 40, 50, 60, designated herein as first, second and third, and the Y-piece 45 are to be connected. Fig. 2 described in more detail.

[0186] The optional fifth connection point 15 is provided and / or suitable for a disinfection cap 30 (see Fig. 4) to include the third line 60, in particular a used or unused disinfection cap 30 of a patient connector 61. This is also described in more detail in connection with Fig. 4 described.

[0187] The control device 100 can be configured to actuate the automatic hose clamps 40b, 50b, 60b. In some embodiments, this can be achieved in a time-controlled and / or volume-controlled manner, preferably based on measured values ​​from various optional additional sensors, for example, an optional flow meter 81. Sensors of other operating modes can also be included independently, complementarily, or as replacements within the present invention, for example, as part of the system in general or as part of the first reusable unit 10, e.g., as an electronic scale 83 (in Fig. 1 not shown, please see Fig. 6), Pressure sensor 84, Turbidity sensor 85, Barcode scanner 86, QR code scanner, RFID scanner, Temperature sensor 87, Glucose meter 88, Conductivity sensor 89.

[0188] In some embodiments, at least two such sensors can form an optional multi-sensor block 90, e.g., with sensors 84, 85, 86, 87, 88, 89, for example, arranged in a row, e.g., all within range of, i.e., with access to, a measuring chamber 55 (or its contents) of the Y-piece 45, or in its vicinity or in contact with it (for further details, please see the description of Fig. 2 and to Fig. 4).

[0189] A communication device 93 can also be included in the system, e.g., by the first reusable unit 10, e.g., in its housing 17. The purpose of the communication device 93 is described in more detail in connection with Fig. 6 described.

[0190] The control or regulating device 100 can be configured to initiate the treatment steps when the system according to the invention is used, namely, for example, to empty, rinse, fill, keep filled and / or (if necessary) empty the first, second and / or third line 40, 50, 50.

[0191] As a power supply, e.g. for the control or regulating device 100, the light emitter 110, the automatic hose clamps 40b, 50b, 60b, the sensors 81, 84, 85, 86, 87, 88, 89, the communication device 93 and / or optional other devices of the organizer 1, the first reusable unit 10 may comprise at least one battery or accumulator 70, as well as the connectors or connections necessary for its proper use, e.g. for charging.

[0192] Fig. 2 shows a disposable 20 for connection with a system according to the invention (see Fig. 4) in an exemplary embodiment.

[0193] In the example of the Fig. 2 The disposable 20 includes a first line 40 for carrying fresh dialysis fluid from a dialysis fluid source or a bag (in Fig. 2 not shown, see Fig. 6) to, for example, a Y-piece 45 or a connector, which is preferably also included by the Disposable 20.

[0194] The Disposable 20 further comprises a second line 50 for conveying used dialysis fluid, hereinafter also referred to as dialysate, away from the Y-piece 45 or connector to a drain or a collection bag 51 (in Fig. 2 not shown, please see Fig. 6).

[0195] The Y-piece 45 is in fluid connection or connected to a third line 60, which is also enclosed by the disposable 20. The third line 60 is designed and / or suitable for directly or indirectly conveying fresh dialysis fluid from or through the organizer 1, in particular away from the Y-piece 45, towards a patient P (in Fig. 2 not shown, please see Fig. 6) to direct, and dialysate away from patient P in the direction of or through organizer 1, in particular in the direction of Y-piece 45.

[0196] In the embodiment of the Fig. 2. The section of the third line 60, the end of which can be connected to the Y-piece 45, can also be referred to as measuring chamber 55 or measuring section, while in other embodiments this can also apply to any other sections of the Y-piece 45 or the third line 60.

[0197] The measuring chamber 55 or measuring area can be an integrated cuvette-like coupling area for non-invasive sensors, for example arranged in the multisensor block 90, as described herein.

[0198] The measuring chamber may have a boundary or edge 55a for ease of handling.

[0199] The Y-piece 45 can have at its end, which points towards the third line 60, a first connector section 47, preferably a first screw connection, to connect it to a corresponding second connector section 49, which is preferably designed as a receiving section which preferably concentrically surrounds the lumen.

[0200] In the embodiment of the Fig. 2 The Disposable 20 optionally includes a self-sealing and / or self-actuating or self-inserting mechanism, here exemplified by a sealing pin 63. This section of the Disposable 20 is shown in an exploded view for better understanding.

[0201] The sealing pin 63 is designed such that it fits at the end of the third line 60, which faces the Y-piece 45, between the Y-piece 45 and the patient connector 61, or in or between the connector sections 47, 49 thereof. The patient connector 61 may have a limit or a rim 61a, particularly for easier handling.

[0202] The sealing pin 63 optionally includes an elongated body with a protruding thread which generates a lumen which allows fluid to be guided through the first connector section 47 and the second connector section 49 when these sections are connected together.

[0203] The protruding thread of the sealing pin 63 can be connected to a threaded section on the inside of the first connector section 47. The thread pitch of the internal thread for connecting the first connector section 47 to the sealing pin 63 and the thread pitch of the external thread for connecting the first connector section 47 to the third line 60 preferably differ from each other.

[0204] The sealing pin 63, or leakage pin or anti-leakage pin, is preferably arranged within the lumen of the first connector section 47 so that fluid can flow through and / or around the sealing pin 63 within the first connector section 47. It can further comprise a first limiting element, preferably in the form of a toothed block, which restricts the rotation of the sealing pin 63 in one direction when it is in a connected state or in a positive-locking connection to a second limiting element within the lumen of the second connector section 49. Such a second limiting element can be configured as a plurality of ribs extending axially along the inside of the wall of the lumen of the second connector section 49.At the end opposite the first limiting element, the sealing pin 63 preferably has a fastening element with which the sealing pin 63 can be detachably or non-detachably fixed to a closure element, preferably by means of a snap connection and / or an undercut.

[0205] When the sealing pin 63 is arranged in the lumen of the second connector section 49, it allows liquid to flow through or along the sealing pin 63 and through or along the lumen of the second connector section 49.

[0206] The sealing pin 63 is arranged in the common lumen formed by the lumens of the first and second connector sections 47, 49. The sealing pin 63 can be moved between an open position, in which the first connector section 47 allows the flow of liquid through the common lumen, and a closed position, in which the sealing pin 63 blocks the flow of liquid, by means of a relative movement of the first connector section 47 to the second connector section 49. In other words, when the patient connector 61 is separated from the Y-piece, the sealing pin 63 remains in the second connector section 49 of the patient connector 61 to seal it against leakage and / or, more importantly, to provide hygienically safe protection against the possible ingress of microorganisms.

[0207] Each of the first, second and / or third lines 40, 50, 60 optionally includes a manual hose clamp 40a, 50a, 60a independently of each other.

[0208] A breaking or predetermined breaking device 33, which must be broken, or any other element which must be manipulated before first use of the Disposable 20, may optionally be provided in the, preferably first, line 40.

[0209] This arrangement can be advantageously used for treatments within the framework of continuous ambulatory peritoneal dialysis (CAPD).

[0210] Fig. Figure 3 shows a second disposable 20 for connection with a system according to the invention in a further exemplary embodiment.

[0211] Reference is made to the reference symbols and the description of Fig. 2. Reference is made. At this point, only the differences to the preceding figure will be discussed.

[0212] In the example of the Fig. 3 the first line 40 may be provided and / or suitable to supply both fresh dialysis fluid from a dialysis fluid source 41 (see Fig. 6) towards the Y-piece 45 as well as dialysate away from the Y-piece towards a drain 51 (see Fig. 6) or an optional cycler.

[0213] This arrangement can be advantageously used with automated peritoneal dialysis (ambulatory peritoneal dialysis / APD). If a cycler is connected to the first line 40 of this arrangement, it can even be used to perform continuous cyclic peritoneal dialysis (CCPD).

[0214] Fig. 4 shows the system according to the invention of Fig. 1 and the Disposable 20 of the Fig. 2 in a connected state. Reference is made to the reference symbols and descriptions of the preceding figures. Some of the reference symbols have been omitted for clarity.

[0215] The first line 40 is connected to the first junction 11 of the first reusable unit 10, the second line 50 to the second junction 12 and the third line 60 to the third junction 13.

[0216] The Y-piece 45 is connected to the third line 60, i.e., its measuring chamber 55, at the fourth connection point 14, preferably in such a way that the measuring chamber 55 or the measuring area can come into contact with the provided sensors 84, 85, 86, 87, 88, 89, 113, as described below. Fig. 1 described.

[0217] The automatic hose clamps 40b, 50b, and 60b can now act on the respective first, second, and third lines 40, 50, and 60 at the connection points 11, 12, and 13. Therefore, the flow within the first, second, and third lines 40, 50, and 60 can be controlled or regulated by means of the control or regulating device 100.

[0218] The following examples may be representative of possible combinations of open / closed terminals. These examples are not exhaustive.

[0219] After an optional break or predetermined breaking device 33 has been broken, for example the automatic hose clamp 40b on the first line 40 and the automatic hose clamp 60b on the third line can be opened, while at the same time the automatic hose clamp 50b is kept closed to protect the patient's abdominal cavity P (in Fig. 4 not shown) with fresh dialysis fluid from a dialysis fluid source 41 (see Fig. 6) to fill.

[0220] If the automatic hose clamp 60b is kept closed, the intraperitoneal pressure (IPP) can be measured, e.g. using the pressure gauge 84 on the third (patient) line 60.

[0221] To empty the abdominal cavity, e.g. after treatment or to exchange the used dialysis fluid, i.e. the dialysate, for fresh dialysis fluid, the automatic hose clamp 60b on the third line 60 and the automatic hose clamp 50b on the second line 50 can be used for the initial and immediate drainage of the patient's abdominal cavity P (in Fig. 4 (not shown) should be opened until the drainage is complete. The drainage can be closed, for example, using an electronic scale 83 (see Fig. 6) be monitored.

[0222] The signaling devices 80 can be provided to indicate the status of the automatic hose clamps 40b, 50b, 60b, i.e., whether they are open or closed. For example, they can change their color for this purpose, e.g., red for closed, green for open. Other light signals, e.g., flashing, on / off, etc., can also be included in the present invention.

[0223] A used or unused disinfection cap 30, which is not required during the treatment of patient P, can be picked up from or at the fifth connection point 15 of the first reusable unit 10.

[0224] The light emitter 110 is in the example of the Fig. 4 is indicated in an upper, middle section of the base body. The control and regulating device 100 can control the light emitter 110 (see Fig. 4) induce, in particular before and / or during the treatment of a patient P (in Fig. 4 not shown, see Fig. 6) To emit light in the direction of the recording(s) or the disposable included therein.

[0225] Optical sensors 113 are arranged in the housing, for example near the light emitter 19 or along the third line, for example at the fourth connection point 14, such that light emitted by the light emitter 110, which is or has been reflected and / or scattered, for example at the sealing pin 63 or other surfaces, can be detected. An exemplary light beam is shown in the Fig. 4 is shown as a dotted, thin arrow.

[0226] Fig. Figure 5 shows the system according to the invention of the preceding figures in a sectional view from the side.

[0227] Reference is made to the reference symbols and descriptions of the preceding figures.

[0228] As an example of the recording of the three lines 40, 50, 60, the Fig. 5 the design of the second connection point 12 as a groove with a connected second line 50 included therein can be seen.

[0229] The control or regulating device 100 is enclosed within the first reusable unit 10, in particular within its housing 17, as is the battery or accumulator 70 of the organizer 1. A charging device 71 is shown next to the organizer 1. The charging device 71 represents any prior art charging device, e.g., inductive or similar.

[0230] The flow meter 81 and the meters or sensors 84, 85, 86, 87, 88, 89 (in Fig. 5 not explicitly shown) of the optional multisensor block 90 are adjacent to the measuring chamber 55 of the third line 60 in order to acquire data as described herein.

[0231] The light emitter 110 is only indicated by dashed lines. Of the optical sensors 113, the following is shown in the example: Fig. 5 only the one which is arranged along the third line, for example in the fourth connection point 14, in order to be able to detect the light emitted by the light emitter 110 and subsequently reflected / scattered (as described herein).

[0232] Fig. Figure 6 shows a system according to the invention in a highly simplified representation during the treatment of a patient.

[0233] Reference is made to the reference symbols and descriptions of the preceding figures.

[0234] The system according to the invention comprises a base body in the form of an organizer 1 for a medical treatment, in the example of the Fig. 6. Dialysis, in particular peritoneal dialysis. This type of treatment is administered via the third line 60 of a disposable 20, here a tubing set (see Fig. 2) indicated which fluid flows into and away from the abdominal cavity of a patient P.

[0235] Besides the Disposable 20, which in the example of the Fig. Figure 6, which is only greatly simplified by means of three lines 40, 50, 60, comprises the basic body, shown here as Organizer 1, exemplarily configured as described in the preceding figures, although in Fig. 6 is only represented very schematically by means of its outer contour.

[0236] The control and regulating device 100 can control the light emitter 110 (in Fig. 6 not shown, see Fig. 4) cause light to be emitted in the direction of the recording(s) or the disposable included therein.

[0237] The control device 100 can be configured to control and / or monitor the treatment of patient P, or parts thereof. For this purpose, in some embodiments, the control device 100 can be configured to cause the emission of light during a specific time or duration that occurs during the treatment of patient P.

[0238] In some embodiments, the control device 100 can be configured to cause the emission of light by means of the light emitter 110 in order to determine therapy-relevant parameters. Additionally or alternatively, it can subsequently control and / or further monitor the treatment of patient P, or sections thereof, based on these determined parameters.

[0239] The light emitter 110 can be further configured to emit light for disinfecting surfaces, for example the sealing pin 63 (see Fig. 4) to emit.

[0240] In some embodiments, this light may be suitable and / or intended to inactivate or attenuate infectious material, in particular bacteria, fungi, spores and / or viruses.

[0241] The light emitter 110 can have at least one LED for the aforementioned purposes; it can be suitable and / or designed to emit infrared (IR), ultraviolet (UV) and non-ultraviolet (non-UV) visual electromagnetic radiation (EMR), preferably with the following wavelengths: 270 nm, 365 nm, 385 nm and 405 nm, at energies between 0.1 kJ / cm² 2 and 1 kJ / cm 2 and 0.005 mW and 1 watt.

[0242] The control device 100 can be further configured to emit light with at least one wavelength of electromagnetic radiation selected from a group of wavelengths as its principal wavelength, in order to disinfect the disposable from one or more target organisms or pathogens. In these embodiments, the control device 100 can additionally be configured to change the principal wavelength of the light emitted by the light emitter 110 between a first principal wavelength and a second principal wavelength that differs from the first principal wavelength, following a selected or predetermined pattern.

[0243] The control or regulating device 100 can be further configured to cause the light emitter 110 to transmit the electromagnetic radiation in a pulsed manner to improve the elimination of pathogens, wherein the pulse width modulation is preferably at a frequency of 100 Hz to 10 kHz, preferably at most 1000 Hz.

[0244] In some embodiments, the light emitter 110 is arranged to emit the hygienically effective light in the direction of a sealing pin 63 of the disposable 20, as already described in [reference to be added]. Fig. 4 executed.

[0245] The first line 40 conveys fresh dialysis fluid from a dialysis fluid source or bag 41 to or through the organizer 1, over or along the third line(s) 60 towards the patient, preferably without using any conveying means, i.e. driven only by gravity.

[0246] After a defined period of time, e.g. after several hours, used dialysis fluid, i.e. dialysate, is drawn out of the abdominal cavity of the patient P via or along the third line 60, to or through the organizer 1, and is then conveyed by means of the second line 50 to a drain or a collection bag 51, preferably also driven by gravity.

[0247] The flow through lines 40, 50, 60 can be controlled by a control or regulating device 100 (see Fig. 1) controlled, which is configured to operate the automatic hose clamps 40b, 50b, 60b (see Fig. 1) to control, for example as described elsewhere herein.

[0248] In some embodiments, the system may further comprise at least one electronic scale 83 for balancing the treatment fluids. Preferably, the scale 83 is battery-operated. In the example of the Fig. At 6, a scale 83 is arranged which weighs both the dialysis fluid source, here represented as bag 41, and the outflow, here also represented as a (collection) bag 51, e.g. to determine the end of the treatment or to monitor its execution. In the example of the Fig. In 6 there is only one scale 83. Any other number of scales is also encompassed by the present invention.

[0249] To fulfill its numerous purposes, the Organizer 1 can be battery-operated, for example by means of a rechargeable battery, e.g., as for... Fig. 5 described.

[0250] The Organizer 1 can perform wireless bidirectional communication with an independent external communication device 95, in which Fig. 6. Displayed using a smartphone, tablet or similar device, support, e.g. via Bluetooth, Wi-Fi or similar.

[0251] In some embodiments of the Organizer 1, the external communication device 95 can function as a data gateway. Secure and efficient communication between the Organizer 1, other external devices (e.g., the battery-powered electronic or digital scale 83, heating devices, blood pressure monitor, etc.), and the external communication device 95 is established and managed via a dedicated application (app), for example, as part of a comprehensive patient app or a facility-specific app. The external communication device 95 acts as a data gateway and provides all modern security and data protection measures offered by modern smartphones or tablets.

[0252] User and / or patient identification and data assignment can preferably also be provided by means of the external communication device 95, for example by means of biometric recognition, e.g. facial recognition or a fingerprint sensor, or by means of a personalized code, or a combination of these measures, which use the proven devices / equipment for external communication from the prior art.

[0253] The control or regulating device 100 of the organizer 1 can in some embodiments be configured to cause status information (e.g. terminal open or closed, battery charge level, error codes, timestamps, etc.) as well as the measurement results of some or all of the meters / sensors 81, 83, 84, 85, 86, 87, 88, 89, preferably at short and / or regular intervals, to be sent to the external communication device 95.

[0254] The external communication unit 95 can itself connect to a secure data cloud 97, receive and process this data, possibly also with the aid of cloud computing (proprietary algorithms), display the results, and send commands to the organizer 1, for example, to open and close the clamps or to initiate specific procedures for preparation, treatment, measurement, calibration, or changes in condition. Using these methods, the entire peritoneal dialysis (PD) therapy is digitized, documented, stored, analyzed, and controlled. Reference symbol list 1 Organizer 10 first reusable unit 11 first liaison point 12 second junction 13 third liaison point 14 fourth liaison point 15 fifth liaison point 17 cases 20 Disposable 30 disinfectant caps 33 Breaking or predetermined breaking device 40 first line 40a manual hose clamp 40b automatic hose clamp 41 Dialysis fluid source or bag 45 Y-pieces 47 first connector section 49 second connector section 50 second line 50a manual hose clamp 50b automatic hose clamp 51 Drain; Collection bag 55 measuring chamber 55a Limit or edge for handling 60 third line 60a manual hose clamp 60b automatic hose clamp 61 patient connectors 61a Limit or edge for handling 63 Sealing pin 65 Patient Management 70 Battery; Rechargeable battery 71 Charging device 80 Signal device; LED 81 flow meters 83 (electronic) scale 84 pressure gauges 85 Turbidity sensor 86 barcode scanners; QR code scanner; RFID scanner 87 temperature gauges 88 glucose meters 89 Conductivity sensor 90 MultiSensorBlock 93 Communication device 95 external communication device 97 Cloud 100 Control or regulating device 110 light emitters 111 Lens 113 optical sensor Patient QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

[0000] DE 10 2018 113 322

[0002] WO 2021 / 043737 A1

[0093] WO 2013 / 159935 A1

[0163]

Claims

[1] System for medical treatment, preferably for dialysis treatment of a patient (P), in particular for treatment by peritoneal dialysis, comprising - a basic body, in particular an organizer (1), with connection points (11, 12, 13, 14) for a disposable; and - a light emitter (110) for emitting light, in particular for inactivating infectious agents. [2] System according to claim 1, comprising a control or regulating device (100) configured to cause the light emitter (110) to emit light. [3] System according to claim 1 or 2, wherein the system comprises a lens (111) arranged to focus light emitted by the light emitter (110). [4] System according to the preceding claim, wherein the light emitter (110) is configured to emit light at a variable wavelength. [5] System according to any of the preceding claims, wherein the system comprises an optical sensor (113) arranged for detecting light emitted by the light emitter (110) and subsequently reflected or scattered. [6] System according to any of the preceding claims, wherein the light emitter (110) is configured to emit light at hygienically effective intensity and / or wavelengths. [7] System according to any of the preceding claims, wherein the light emitter (110) is arranged to emit light in the direction of the recording or of a disposable recorded therein. [8] System according to any one of claims 2 to 7, wherein the control or regulating device (100) is configured to control and / or monitor a treatment of the patient (P), or sections thereof. [9] System according to any one of claims 2 to 8, wherein the control or regulating device (100) is configured to cause the emission of the light during a time or duration which is during the treatment of the patient (P). [10] System according to any one of claims 2 to 9, wherein the control or regulating device (100) is configured to cause the emission of light by means of the light emitter (110) in order to determine therapy-relevant parameters. [11] System according to any of the preceding claims, wherein the light emitter (110) is configured to emit light for disinfecting surfaces. [12] System according to any of the preceding claims, wherein the light emitter (110) is configured to inactivate or attenuate infectious material, in particular bacteria, fungi, spores and / or viruses. [13] System according to one of the preceding claims, wherein the light emitter (110) preferably comprises at least one LED for emitting infrared (IR), ultraviolet (UV) and non-ultraviolet (non-UV) visual electromagnetic radiation (EMR), preferably 270 nm, 365 nm, 385 nm and 405 nm at energies between 0.1 kJ / cm 2 and 1 kJ / cm 2 and 0.005 mW and 1 watt. [14] System according to any one of claims 2 to 13, wherein the control or regulating device (100) is configured to emit light with at least one wavelength of electromagnetic radiation selected from a group of wavelengths as the principal wavelength in order to disinfect the target location of the emitted light, e.g. the disposable (20) or a section thereof, from one or more target organisms or pathogens. [15] System according to any one of claims 2 to 14, wherein the control or regulating device (100) is configured to change the principal wavelength of the light emitted by means of the light emitter (110) between a first principal wavelength and a second principal wavelength which differs from the first principal wavelength, following a selected or predetermined pattern. [16] System according to any one of claims 2 to 15, wherein the control or regulating device (100) is configured to cause the light emitter (110) to transmit the electromagnetic radiation in a pulsed manner to improve the elimination of pathogens, wherein the pulse width modulation is preferably at a frequency of 100 Hz to 10 kHz, preferably at most 1000 Hz. [17] System according to one of the preceding claims, wherein the light emitter (110) is arranged to emit the hygienically effective light in the direction of a sealing pin (63) of the disposable (20). [18] Method for preparing or preparing a system for medical treatment, preferably for dialysis treatment of a patient (P), in particular for treatment by peritoneal dialysis, according to any of the preceding claims, comprising the step of: - Emitting light by means of the light emitter (110), in particular for inactivating infectious agents, onto a disposable (20) of the system or onto a receptacle or connection points (11, 12, 13, 14) for connecting a base body of the system to a disposable.

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