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WO2025219229A1 - Système de dialyse péritonéale avec émetteur de lumière - Google Patents

Système de dialyse péritonéale avec émetteur de lumière

Info

Publication number
WO2025219229A1
WO2025219229A1 PCT/EP2025/059982 EP2025059982W WO2025219229A1 WO 2025219229 A1 WO2025219229 A1 WO 2025219229A1 EP 2025059982 W EP2025059982 W EP 2025059982W WO 2025219229 A1 WO2025219229 A1 WO 2025219229A1
Authority
WO
WIPO (PCT)
Prior art keywords
light
light emitter
control
line
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/059982
Other languages
German (de)
English (en)
Inventor
Joerg Jonas
Ulrich TSCHULENA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Publication of WO2025219229A1 publication Critical patent/WO2025219229A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/15—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit
    • A61M1/159—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with a cassette forming partially or totally the flow circuit for the treating fluid, e.g. the dialysate fluid circuit or the treating gas circuit specially adapted for peritoneal dialysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/168—Sterilisation or cleaning before or after use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/08—Radiation
    • A61L2/10—Ultraviolet radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3576—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3584—Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using modem, internet or bluetooth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated

Definitions

  • 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.
  • An object of the present invention is to provide a further system for medical treatment. It has a base body, which can be an organizer.
  • the object of the invention is achieved by a system having the features of claim 1 and a method having the features of claim 18.
  • 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 device, and a light emitter for emitting light, in particular for inactivating infectious pathogens.
  • Typical examples of a disposable can be a dialysis catheter or a tube or a tubing system or a connector or any disposable dialysis product for peritoneal dialysis (CAPD or APD).
  • APD peritoneal dialysis
  • the present invention also relates to a method for preparing or processing the system for a treatment by means of peritoneal dialysis, with an emission of light by means of the light emitter, in particular for inactivating infectious pathogens, onto a disposable when connected to the main body of the system, or onto a receptacle or connection point for connecting the main body to a disposable.
  • Reprocessing can take place during the treatment, e.g. once or several times, e.g. at predetermined time intervals, or after a predetermined period of time, measured approximately from the start of the treatment.
  • Preparation takes place before the start of treatment, e.g. while the system is not yet connected to the patient, especially not in fluid connection.
  • Embodiments of the invention may, based on any of the independent claims, comprise one or more of the features mentioned above or below.
  • the features mentioned herein may, in any combination, be the subject of embodiments of the invention based on any of the independent claims, provided that the person skilled in the art does not recognize a specific combination as technically impossible.
  • the use of the expression “may be” or “may have” etc. is to be understood as synonymous with “is preferably” or “preferably has” etc. and is intended to explain embodiments of the invention.
  • Embodiments as disclosed herein further develop the invention as defined by the independent claims.
  • the optional control device of the system is configured in some embodiments to carry out one, several or all of these method steps, in particular if these are automatically performable steps, in any combination, or to control corresponding devices, which are preferably based on the name of the respective method step (e.g. "determining” as a method step and “device for determining” for the device, etc.) and which can also be part of the device(s) according to the invention or can be connected thereto in a signal connection.
  • determining as a method step and “device for determining” for the device, etc.
  • Biomarkers can include, for example, urea, creatinine, ß2-microglobulin, a wide variety of proteins and/or other carbon-containing substances.
  • Biomarkers can include exploratory biomarkers such as, for example, soluble CD59 (to check the membrane function of the peritoneum), fibroblast growth factor 23 (FGF23, as a biomarker for inflammation), interleukin-6, matrix metalloproteinase 8 and neutrophil gelatinase-associated lipocalin (neutrophil gelatinase-associated lipocalin (NGAL)), for example as a biomarker for detecting peritonitis.
  • exploratory biomarkers such as, for example, soluble CD59 (to check the membrane function of the peritoneum), fibroblast growth factor 23 (FGF23, as a biomarker for inflammation), interleukin-6, matrix metalloproteinase 8 and neutrophil gelatinase-associated lipocalin (neutrophil gelatinase-associated lipocal
  • a signal or communication connection between two components this may be understood as a connection that is already in use. It may also be understood as preparation for such a signal connection (wired, wireless, or implemented in another way), for example, by coupling the two components, such as by pairing, etc.
  • Pairing is a process that occurs in computer networks to establish an initial connection between computer units for the purpose of communication.
  • the best-known example is establishing a Bluetooth connection, which connects different devices (e.g., smartphones, headphones). Pairing is sometimes also referred to as bonding. If method steps are mentioned herein, it is provided in some embodiments that these take place before or after a 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 a treatment has not yet begun or has already ended.
  • the control device can initiate the execution of all or substantially all method steps.
  • the method according to the invention can be executed substantially or entirely by the control device. It can be executed partially by the control device; in particular, those steps which do not require or involve human intervention and/or provision can be executed by the control device.
  • the control device can serve as a pure control device or also as a regulating device.
  • 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 regard to the question of when light is to be emitted by means of the light emitter.
  • a switch e.g. necessarily actuated when the disposable is inserted into e.g. a connection point, can e.g. be a trigger for the control or regulating device to act on the light emitter, for example immediately when the switch is actuated, a predetermined period thereafter, etc.
  • the system includes a lens arranged to focus light emitted by the light emitter.
  • the lens is arranged to focus the light toward the receptacle or disposable.
  • the light emitter is configured to emit light at a variable wavelength.
  • the system includes an optical sensor arranged to detect light emitted by the light emitter and subsequently reflected or scattered.
  • This can be configured, for example, as a color sensor.
  • the system additionally or alternatively comprises at least one capacitive sensor and/or at least one Hall sensor.
  • the above sensors may be arranged on a multi-sensor block, on a hose set or system and/or on a measuring chamber, each as disclosed herein.
  • the light emitter is configured to emit light at hygienically effective intensities and/or wavelengths.
  • the light emitter is arranged to emit light toward the receptacle or a disposable received therein.
  • the control or regulating device is configured to control and/or monitor a treatment of the patient, or portions thereof.
  • control or regulating device is configured to cause the light to be emitted during a time or period of time that is during the treatment of the patient.
  • control or regulating device is configured to cause the light emitter to emit light in order to determine therapy-relevant parameters. In certain embodiments, this emission occurs during the treatment of the patient.
  • Such parameters include, for example, the exposure to pathogens (bacteria, viruses, etc.) and/or the concentration of glucose, electrolytes, proteins, biomarkers or blood cells.
  • a measurement of the reflection or scattering of the emitted light by means of a sensor can, in some embodiments, not only detect pathogens but optionally even enable their identification.
  • the concentration of glucose, electrolyte, protein, Biomarkers or blood cells can be measured.
  • blood cells can be classified by measuring the scattering of light.
  • the light emitter is configured to emit light for disinfecting surfaces.
  • the light emitter can emit radiation from the part of the electromagnetic spectrum that is not visible to humans.
  • the light emitter is configured to inactivate or attenuate infectious material, particularly bacteria, fungi, spores and/or viruses.
  • the light emitter preferably comprises at least one LED and/or a laser designed to emit infrared (IR), ultraviolet (UV), and non-ultraviolet (non-UV) visible electromagnetic radiation (EMR).
  • IR infrared
  • UV ultraviolet
  • NMR non-ultraviolet
  • light or electromagnetic radiation is emitted at 270 nm, 365 nm, 385 nm, and 405 nm, at energies between 0.1 kJ/cm 2 and 1 kJ/cm 2 and between 0.005 mW and 1 watt.
  • the light emitter is an EMR transmitter, for example, comprising an LED and/or a laser, a refractive lens, the associated electronic components and cabling, and a shaping element, e.g., a framework.
  • the LED(s) can emit electromagnetic radiation according to their inherent scattering. emit or use other optical elements for this purpose. Such optical elements can be or include lenses, mirrors, filters, or the like, each suitable and/or intended to focus or scatter the electromagnetic radiation in a desired direction.
  • a plurality of LEDs are arranged, for example in a row, to emit one of the aforementioned radiations, for example electromagnetic radiation.
  • the radiation is guided to its site of action, e.g., a catheter, the organizer around the catheter, the disposable, particularly the tube seat or tube connector, the connector, or a fluid bag, by means of an elongated tubular or solid body (e.g., an optical fiber 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 contain a vacuum.
  • 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.
  • the light emitter is arranged to direct the radiation, e.g. the 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 on the tube wall or by a light-conducting component.
  • a component can be made, for example, from a polymer which, in some embodiments, can partially and additionally contain reflective particles.
  • Such a component can be provided to scatter the light more and to irradiate larger areas around the catheter line with disinfecting radiation, in particular electromagnetic radiation.
  • the light emitter is arranged to irradiate by means of the radiation, in particular the electromagnetic radiation, 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).
  • the radiation in particular the electromagnetic radiation
  • 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).
  • control or regulating device is configured to emit light having at least one wavelength of the electromagnetic radiation selected from a group of wavelengths as the main wavelength in order to disinfect the target location of the emitted light, e.g. the disposable or a portion thereof, from one or more target organisms or pathogens.
  • control or regulating device is configured to alternate the main wavelength of the light emitted by the light emitter between a first main wavelength and a second main wavelength that differs from the first main wavelength. Such alternating may, in certain embodiments, follow a selected or predetermined pattern.
  • control or regulating device is configured to cause the light emitter to transmit the electromagnetic radiation in pulsed fashion to improve pathogen elimination.
  • the pulse width modulation is preferably at a frequency of 100 Hz to 10 kHz, preferably at a maximum of 1000 Hz.
  • the light is emitted 30% to 50% of the time and not emitted 70% to 50% of the time.
  • the (as always herein, unless otherwise specified: at least one) light emitter may be provided and/or configured to emit multiple 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 may also be emitted by the one light emitter simultaneously. Different patterns of light emissions are also encompassed by the present invention.
  • This light of different wavelengths, emitted axially or radially by the light emitter into the system according to the invention can be used for light-based diagnostics by determining (patient) parameters relating to the dialysis fluid or effluent, such as its turbidity.
  • an optical sensor 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.
  • the optical sensor 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 location.
  • the material of the system according to the invention preferably enables the conduction and transmission of diagnostic electromagnetic radiation to the sensor.
  • the optical sensor is preferably able to generate diagnostic information from reflected light passing through the system and the corresponding fluids in two directions. This can be determined by detecting, for example, color, scattering by obstacles, light intensity, absorption, the transmission of light of different wavelengths, the flow (in and out) in the disposable, etc. An observed turbidity can, for example, already be an indication of an infection. In this way, for example, a glucose, electrolyte or Biomarker concentration and/or types of blood cells are determined and/or infectious agents (e.g. bacteria, fungi, viruses) as well as their concentration and classification are detected.
  • infectious agents e.g. bacteria, fungi, viruses
  • the light emitter is arranged to emit hygienically effective light in the direction of a sealing pin or outlet stiffener of the system, preferably the disposable.
  • the control or regulating device can cause all or almost all of the process steps to be carried out.
  • conduits are suitable and/or intended to conduct fluids or liquids.
  • automated hose clamp Whenever the term “automatic hose clamp” is used herein, this term may include automated hose clamps, electromagnetic hose clamps and/or the like
  • sealing pin Whenever the term “sealing pin” is used herein, this term may be a synonym for “safety pin” or “locking pin.” In some embodiments, these terms may be interchangeable.
  • the “third line” herein may also include a “patient line”, which in some embodiments may be implemented as a catheter extension.
  • patient line which in some embodiments may be implemented as a catheter extension.
  • sensor reader
  • reader reader
  • scanner scanner
  • the system includes a dialysis fluid source or bag and/or a drain or collection bag. In other embodiments, this is not the case.
  • the system according to the invention comprises a power source, for example a battery, rechargeable battery, accumulator or the like, or is connected to such a power source.
  • a power source for example a battery, rechargeable battery, accumulator or the like, or is connected to such a power source.
  • the base body or the first reusable unit (hereinafter also referred to as the base body) is or comprises a tray or a tray-shaped or -like body.
  • the base body does not comprise any lines for conveying fluids to or from the patient as long as it is not connected to the disposable.
  • the base body encompasses or is connected to the disposable.
  • the disposable can be connected to the base body via the first connection point and/or vice versa.
  • the first connection point can be or comprise at least one first receiving device, for example a groove and/or a clamping portion.
  • the disposable comprises a first line for carrying fresh dialysis fluid from a dialysis fluid source or a bag (which are optionally also included in the system) and a second line for carrying used dialysis fluid, also referred to herein as dialysate, to or into a drain or a collection bag (which are optionally also included in the system).
  • Both lines are connected to one another, i.e. in fluid communication, preferably via a Y-piece, a connector or another line section.
  • the Y-piece or the other line section is in fluid communication with a third line, through or along which fresh dialysis fluid is carried from or through the organizer or the disposable to the patient and used dialysis fluid is carried away from the patient to or through the organizer or the disposable.
  • the disposable comprises a first line for conducting fresh dialysis fluid from a dialysis fluid source or a bag to the organizer, or its base body, and for conducting 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 the first line or is connected thereto.
  • the first line comprises a hose clamp, in particular a manual one.
  • the second line comprises a hose clamp, in particular a manual one.
  • the third line comprises a patient tube clamp, in particular a manual one.
  • the Y-piece or the third conduit comprises or is configured as a measuring chamber or a measuring section.
  • the measuring chamber or section may differ from adjacent sections in structure, light transmittance, wall thickness, and/or the like.
  • the Y-piece, the third line, and/or the measuring chamber include a limit or rim for user handling.
  • the limit or rim can be designed as a protrusion that prevents the disposable from slipping through the user's fingers during system setup. Thus, it can protect the measuring chamber or line from accidental touch or contamination by the user (keyword: "touch contamination”). This can ensure the correctness and accuracy of future measurements.
  • the third line which may comprise a patient line or be extended by means of such a line and may further comprise a patient line connector (in short: patient connector) for optionally connecting the patient line to further sections of the third line, for example the measuring chamber or section, may comprise a connection point or coupling point, preferably a screw connection.
  • This connection or coupling point may serve to connect sections of the third line to a sealing pin, which in turn is also part of the third line. or may be encompassed by it.
  • the connection point may be the patient line connector or a portion thereof, if provided.
  • a portion of the third line that connects to the optional Y-piece, the measuring chamber or section, or any other portion of the third line has a first connector portion, while the patient connector has a second connector portion.
  • the first and second connector portions may fit together or complement each other, for example, as a screw connection and screw, preferably to create a fluid-tight connection. Both connector portions provide a lumen to allow fluid to pass therethrough. Both connector portions may be arranged to connect to the sealing pin mentioned herein. Both connector portions may be arranged to form a common lumen into which the sealing pin mentioned herein is or will be inserted.
  • the sealing pin or a portion thereof has a lumen through which fluid can flow along the sealing pin.
  • the sealing pin can be disposed, at least partially, in the lumen of the first connector portion, the second connector portion, or the common lumen to allow fluid to flow through and/or along the sealing pin, thus forming a conduit leading from the first connector portion to a conduit connected to the second connector portion, or vice versa.
  • the sealing pin has a threaded portion on its outer side which is suitable for threaded engagement with the first connector portion, wherein the first connector portion in turn may have a threaded portion on the inner side.
  • the sealing pin further comprises a first limiting element.
  • the first limiting element can be an element which limits the movement of the sealing pin relative to the second connector portion, or it can be part of a mechanism therefor.
  • the first limiting element can be an edge or, preferably, have the form of teeth, a toothed block, projections or the like which limits rotation of the sealing pin in at least one rotational direction when it is in contact with a second limiting element or another portion of the second connector portion which is suitable for engaging the first limiting element.
  • 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 releasably or non-releasably fastened to a closure element, preferably by means of a snap-in connection and/or by means of an undercut, for example such as a sealing cap or disinfection cap.
  • the second connector portion has a receiving portion, which preferably concentrically surrounds the lumen of the second connector portion, for receiving a first threaded portion on the outside of the first Connector portion , wherein the receiving portion of the second connector portion has on its inner side a threaded portion which is suitable for coming into ( threaded ) engagement with the first threaded portion of the first connecting portion .
  • a second limiting element is arranged on the inside of the lumen of the second connector portion on the lumen side.
  • This second limiting element preferably has the shape of a toothed block and is adapted to cooperate with the corresponding first limiting element of the sealing pin to limit the rotation of the sealing pin in at least one rotational direction.
  • the second limiting element is designed in the form of a plurality of ribs which extend axially along the inside of the second connector portion and/or as grooves in or on an inner surface of the second connector portion.
  • 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 some embodiments.
  • the sealing pin is arranged in a common lumen which is formed by the lumens of the first and second connector sections, wherein the sealing pin is arranged in a relative movement of the first connector section to the second connector section between an open position in which the sealing pin allows fluid flow through the common lumen, and a closed position in which the sealing pin prevents fluid flow through the common lumen.
  • the third lead is connected to or includes the patient connector.
  • the patient connector is or includes the second connector portion.
  • the third line includes a self-injecting and/or self-sealing mechanism to seal the patient connector upon disconnection.
  • the sealing pin as described herein may be the self-initiating and/or self-sealing mechanism or a part thereof.
  • the self-injecting and/or self-sealing mechanism is implemented as disclosed in WO 2021/043737 A1, the corresponding disclosure of which is incorporated herein by reference.
  • the self-injecting and/or self-sealing mechanism is or comprises the first connector portion, which has a lumen for guiding fluid; the first threaded portion, which is arranged on an outer side of the first connector portion and which enables a detachable connection of the first connector portion to the correspondingly mating second connector portion; and a second threaded portion which is arranged on an inner side or on the lumen side of the first connector portion and which enables a detachable connection of the first connector portion to the correspondingly matching sealing pin, wherein the thread pitch of the first threaded portion preferably differs from the thread pitch of the second threaded portion.
  • the patient connector includes a border or rim for ease of handling.
  • 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 via or by the control or regulating device of the system.
  • the system comprises at least one signaling device to indicate the status of the automatic hose clamps, in particular whether they are open or closed.
  • the at least one signaling device is designed as an LED.
  • the at least one signaling device can change color to indicate the status of the hose clamp, for example, red for closed, green for open.
  • Other light signals for example blinking, on/off etc., can also be encompassed by the present invention.
  • the first line comprises a break or predetermined breaking device, or the system provides a break or predetermined breaking device for any of the first, second or third lines, in particular for the first line.
  • the base body or the first reusable unit can include a kink aid.
  • the tubing dimensions of the line are selected such that a breakable edge of the breakable or predetermined breaking device is located near an edge or breakthrough opening, a projection, an edge, or the like of the organizer, where an edge allows breaking when the tubing is bent over it.
  • 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 above-mentioned closure element.
  • the fifth connection point may be or include at least one fifth receiving device.
  • the system or organizer includes a disinfection cap or sealing cap.
  • the system or organizer includes a control or regulating device that includes a microprocessor, CPU, or other processing device.
  • the control or regulating device may be used to perform and/or control some or all of the automated functions of the system.
  • Automated functions can be understood, for example, as some or all functions that do not involve human intervention or provision by a user/human.
  • the control or regulating device can automatically execute a program, algorithm, or the like and is capable of making decisions based on this and controlling the intended processes if necessary.
  • the automated functions herein can include, for example, initiating measurements, actuating automatic hose clamps, automatic data acquisition, data transmission, and the like.
  • control or regulating device is configured to control the actuation of the automatic hose clamps.
  • the system comprises 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.
  • the control or regulating device is configured to control the actuation of the automatic hose clamps in relation to time and/or volume, preferably based on measured values of the flow sensor, the electronic scale, the optical sensor and/or another sensor, for example, as set forth herein.
  • control or regulating device automatically detects the presence of a disposable and/or only functions when the disposable is correctly inserted.
  • Appropriate sensors, probes, or other devices may be provided. They may communicate with the control or regulating device accordingly.
  • 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 the, in particular initial, drainage after connecting the patient until there is no more flow - or no change in weight if a scale is used alternatively - or no significant fluid flow or no significant change in weight is recorded within a predetermined period of time and/or the drainage of the fluid from the abdominal cavity of the patient is considered to be complete.
  • initial drain When a new ADP treatment is started, it is important to drain any fluid that may have accumulated in the abdominal cavity by means of the initial drain. Remove before the first filling cycle is performed. With the drain clamp opened in advance, drainage can begin spontaneously and immediately as soon as the patient is connected to the third line of the disposable, without any further action being necessary.
  • control or regulating device is configured to cause drainage, flushing, filling, retention and/or (re-)flow into, through or out of the first conduit, second conduit and/or third conduit.
  • 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.
  • control or regulating device is configured to cause the removal of air from the first conduit.
  • Control device configured to provide a flow of fresh To allow dialysis fluid to flow along the first line and the third line into the abdominal cavity for therapeutic purposes. This is accomplished by keeping the second line's automatic clamp closed and the first line's automatic clamp and the third line's automatic clamp open until a prescribed volume of fluid has been infused.
  • control or regulating device is configured to keep all automatic tube clamps closed during a prescribed therapeutic dwell time.
  • control or regulating device is configured to keep the automatic tube clamp of the second line, also referred to herein as the drain line, and the automatic tube clamp of the third line open during the drainage of the dialysate from the abdominal cavity, while the weight of one or more of the bags in use is monitored 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 that cycle is considered to be complete.
  • control or regulating device is configured to determine the fluid volumes draining from and/or infused into the patient. This can be done either by timely integration of the values measured by a coupled flow sensor, for example at the measuring chamber or section, or by monitoring an optional scale that registers the differential weight change of fresh dialysis fluid or drained dialysate.
  • the difference between effluent (flowed out) and infused volume, or the change in total weight represents the achieved ultrafiltration or even the absorbed liquid.
  • control or regulating 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.
  • the same sensor is used for both measurements (in and out).
  • the system comprises one or more sensors for measuring, for example, glucose concentration, other biomarkers, turbidity, temperature, and/or conductivity.
  • the sensors are preferably 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.
  • control or regulating device is configured to automatically control the fluid flowing out of the abdominal cavity by means of the The turbidity sensor, which is connected to the measuring chamber or line, should be checked for increased opacity to advantageously increase patient safety.
  • Increased opacity can indicate the presence of white blood cells or an elevated protein concentration, and thus a potential infection (peritonitis).
  • control and regulation device is configured to calibrate the turbidity sensor and/or other optical sensors during the infusion of the fresh dialysis fluid along the first line.
  • control or regulating device is configured to monitor or continuously monitor 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 by means of the temperature sensor.
  • the measured values can be used to correct all other temperature-dependent values.
  • the temperature sensor can be used to monitor and control the temperature of the inflowing fluid and stop the flow if the measured temperatures are outside permissible safety limits.
  • the temperature sensor coupled to the measuring chamber or section can also measure the patient's core body temperature at the outflowing fluid and detect an elevated temperature or fever. This may indicate a potential infection. This may be seen alone (e.g., in a bidirectional measurement) or combined with the turbidity measurement results, indicating peritonitis.
  • 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 the dialysate during the outflow along the third line, alternatively along the second or third line.
  • This value can then be compared to the prescribed glucose concentration, allowing adherence to the treatment plan to be monitored and confirmed. An alarm can be triggered in the event of significant discrepancies.
  • a 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 be compared in a second step with the glucose concentration of the dialysate flowing out. In this way, further therapy-relevant information can be obtained to determine the suitability of the therapy and the water removal.
  • the glucose meter can be used to check the blood glucose level when setting up automatic routine tests. the function of the peritoneal membrane (peritoneum) and enable precise PD therapy.
  • 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, in particular in the first or third line.
  • the fresh dialysis fluid e.g. fluid from a bag, a mixture of bags or prepared on site
  • This baseline measurement is then compared with the conductivity of the dialysate flowing out. This allows for the acquisition of relevant information regarding the suitability of the therapy and the peritoneal performance, which advantageously enables precise PD therapy.
  • control or regulating device is configured to determine, prior to connecting the patient, by means of at least one of the 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 comprises the patient line) is completed and all air has been removed from the lines.
  • the appropriate actuation of the automatic hose clamp of the second line ensures that the system is filled air-free and ultimately terminates the filling process.
  • the system includes a barcode scanner, QR code scanner, and/or RFID scanner. These types of sensors may be capable of reading a variety of information, such as the type of product, concentrations, an item number, a serial number, an expiration date, and/or the like.
  • This information from a type of e.g. matrix (2D) barcode or RFID, which is attached or printed on the side of the measuring chamber or section, can enable checks with regard to therapy compliance and provide product-related information, for example for documentation of the therapy.
  • (2D) barcode or RFID which is attached or printed on the side of the measuring chamber or section
  • the system includes a pressure gauge to measure the hydrostatic pressure within the patient's abdominal cavity, called intraperitoneal pressure (IPP).
  • IPP intraperitoneal pressure
  • Such a pressure gauge can be arranged in a kind of shaft of the base body or the first reusable unit next to the third connection point for the third line. It can then be able to measure the pressure within the third line, which corresponds to the IPP, very precisely and without external influences, provided the automatic tube clamp of the third line is closed.
  • the pressure prevailing in the connected bags for dialysis fluid and dialysate
  • the manual tube clamp of the third line is closed towards the patient and the corresponding tube clamps of the first and second lines are opened.
  • the opening and closing of the automatic Tube clamp can ensure that only pressure values are determined that reflect the pressure in the patient's abdominal cavity.
  • control or regulating device is configured to close or maintain the automatic tube clamp of the third line closed while measuring the pressure prevailing in the abdominal cavity of the patient.
  • control or regulating device is configured to initiate pressure measurements during the inflow, retention, or outflow of the dialysis fluid and to evaluate the measured values thus obtained. It may remain open whether changes in the measured values are measured during the inflow, retention, or outflow of dialysis fluid, or when these values are determined.
  • control or regulating device is configured to automatically calibrate the pressure gauge, e.g., at periodic intervals. This may be accomplished by a method in which the dialysis fluid bags are mounted or fixed at a certain 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.
  • one, some, or all of the meters or sensors are/are regularly calibrated or checked automatically, preferably by means of the control or regulating device, before each treatment, preferably in a separate process and/or during the filling process using standard ACPD or ADP solution flowing past the sensors or the at least one multi-sensor block. This is done to advantageously define individual starting or reference values in a simple manner, in particular based on fresh dialysis fluid.
  • the system includes a multi-sensor block, which in turn includes some or all of the meters or sensors of the system that are or will be described herein.
  • control or regulating device or another component of the system or organizer comprises an external communication device, preferably to act as a data gateway.
  • the secure and efficient communication between the organizer, its base body, other external devices (e.g. battery-operated digital scales, a heating device, a blood pressure monitoring device, etc.) and the external communication device can be established or managed via a dedicated application (app for short), for example as part of a holistic patient application or a device-specific application. 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.
  • a dedicated application app for short
  • 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.
  • the external communication device is used for user and/or patient identification and data association. This can preferably be done by means of biometric recognition, e.g., Face ID or a fingerprint sensor, or by means of a personalized code, a combination of these measures, using proven devices for external communication such as smartphones, tablets, or the like from the state of the art.
  • the control or regulating device can be configured to initiate the sending of status information to the external communication device, e.g., terminal open or closed, battery charge level, error codes, time stamps, etc., as well as the measurement results from some or all of the system's meters or sensors.
  • the organizer supports wireless bidirectional communication, e.g., via Bluetooth, Wi-Fi, or others, to establish or maintain signal communication with an independent external communication device, such as a patient's smartphone, tablet, or the like.
  • an independent external communication device such as a patient's smartphone, tablet, or the like.
  • a signal or communication connection between two components may be understood as a connection that is already in use. It may also be understood as a preparation for a such a signal connection (wired, wireless or implemented in some other way), for example by coupling both components, such as by pairing, etc.
  • Pairing is a process that takes place in computer networks to establish an initial link between computer units for the purpose of communication. The best known example of this is the establishment of a Bluetooth connection, by means of which various devices (e.g. smartphone, headphones) are connected to one another. Pairing is sometimes also referred to as bonding.
  • 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 as known in the art can be used for this purpose.
  • the external communication unit can be configured to display data and/or information, for example, 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 clamps and/or to initiate certain preparation, treatment, measurement, or calibration measures or status changes. By means of these measures, the entire therapy or treatment can advantageously be digitized, documented, stored, analyzed, and/or controlled.
  • 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.
  • the organizer is capable of functioning autonomously and is not necessarily dependent on the 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, e.g., in or on a suitable storage device provided therefor. They can be moved to the external communication device and further to the cloud whenever a connection is available. In some embodiments, this can apply in both directions.
  • the system includes a camera.
  • the system comprises 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 can be provided and included in the system.
  • the heating device comprises a communication device for signal communication with, for example, the organizer and/or the external communication device, or corresponding portions thereof.
  • the heating device comprises a receptacle or a container, in particular foldable.
  • the heating device or a receptacle or container thereof, comprises an insulating cover.
  • the organizer has a soft shape, preferably a teardrop shape without protruding and/or sharp edges, to provide increased comfort during use.
  • control or regulating device is not configured to estimate particle concentrations and/or leukocyte concentrations, for example based on the measurements that have been or are being performed by the intended meters or sensors.
  • the base body or the first reusable unit and/or the disposable do not include an additional fluid line or fluid bypass line for conducting fluid from one of the components to the sensors provided herein or along the line/bypass line.
  • an additional fluid line or fluid bypass line for conducting fluid from one of the components to the sensors provided herein or along the line/bypass line.
  • the pressure gauge may be connected to the base body or the first reusable unit or the disposable by means of a special line/bypass line.
  • the system does not include any substance for calibrating the knives or sensors.
  • urea is not measured and/or no percentage based on detected urea is calculated by the control or regulating device or any other element of the system.
  • 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 marketed by Fresenius Medical Care, Germany, compare its disclosure in WO 2013/159935 A1, the corresponding disclosure of which is hereby incorporated by reference), which has to be inserted into or connected to the main body or the first reusable unit, is required in order to use the system and/or is not included here.
  • a connector for example a so-called “stay safe” connector (which is part or disc of an organizer and is commercially marketed by Fresenius Medical Care, Germany, compare its disclosure in WO 2013/159935 A1, the corresponding disclosure of which is hereby incorporated by reference), which has to be inserted into or connected to the main body or the first reusable unit, is required in order to use the system and/or is not included here.
  • One advantage of the present invention may be that the disinfection of disposable 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.
  • a further advantage of the present invention may be that the light emitter can also be used for diagnostic measurements. Results from these diagnostic measurements can be used to improve the quality and suitability of the
  • Peritoneal dialysis and thus also the Well-being and health, inter alia by triggering adjustments of therapeutic prescription and/or medication at an early stage following such a diagnosis.
  • UV visible or invisible
  • EMR visible or invisible electromagnetic radiation
  • Fig. 1 shows a system according to the invention in an exemplary embodiment
  • Fig. 2 shows a disposable for connection to a system according to the invention in an exemplary embodiment
  • Fig. 3 shows a second disposable for connection to 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 Fig. 2 in a connected state
  • Fig. 5 shows the system of the preceding figure in a sectional view from the side
  • Fig. 6 shows a system according to the invention in a highly simplified representation during the treatment of a patient.
  • Fig. 1 shows a system according to the invention in an exemplary embodiment.
  • the system comprises a base body.
  • This base body exemplified here as a "first" reusable unit 10 of the organizer 1
  • the disposable 20 can, in some
  • Embodiments may also be, as referred to herein as such, a "second" (disposable) unit of the organizer 1.
  • 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.
  • the housing 17 is preferably made of hard, preferably disinfectable material or comprises exactly or at least such a material.
  • the first reusable unit 10 can be provided to be connected to the disposable 20 (see Fig. 2 and Fig. 4).
  • 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 encompassed by the present invention).
  • the connection points are designed, for example, as grooves or comprise grooves.
  • any of the - respectively optional - first connection point 11, second connection point 12 and/or third connection point 13 comprise an optional, automatic hose clamp 40b, 50b or 60b, the purpose of which is explained in connection with Fig. 4.
  • the system comprises a light emitter 110 for emitting light.
  • This light is intended and/or suitable, in particular, for inactivating infectious pathogens.
  • the base body in particular its organizer 1 or first reusable unit 10 or any other section of the system, may further comprise a control or regulating device 100 which in turn may include a microprocessor or a CPU.
  • the control or regulating device 100 may be configured or programmed to perform and/or control some or all of the automated functions, measurements, data acquisition, and/or data transmissions.
  • the control and regulating device 100 is surrounded by or accommodated in the housing 17.
  • the control or regulating device 100 of the system is preferably provided and/or configured to cause the light emitter 110 to emit light.
  • the control or regulating device 100 can optionally be configured to cause the light emitter 110 to emit light at a variable wavelength.
  • the light emitter 110 can be provided and/or configured for this purpose, in particular, can be caused to do so.
  • the control or regulating device 100 can optionally be configured to cause the light emitter 110 to emit light at a hygienically effective intensity and/or hygienically effective wavelengths.
  • the light emitter 110 can be provided and/or configured for this purpose.
  • the system has an optional lens 111 which is arranged to focus light emitted by the light emitter 110.
  • the system optionally has, as in other embodiments, one or more, here three, optical sensors 113. These are arranged to detect light, which was 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 Fig. 1 is purely exemplary and not to be understood as limiting. Any other number and/or other arrangement of optical sensors is also encompassed by the present invention.
  • An optional signaling device 80 e.g., an LED, is arranged adjacent 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 is also described in more detail in Fig. 4.
  • the optional fourth connection point 14 may be provided and/or adapted to receive a line, referred to herein as the third line 60, preferably a measuring chamber 55 or a portion thereof, which can be connected to a patient line 65 (FIGS. 2 and 3) during the treatment of a patient P (not shown in Fig. 1).
  • the lines 40, 50, 60 referred to herein as the first, second, and third, as well as the Y-piece 45, are described in more detail in relation to Fig. 2.
  • the optional fifth connection point 15 is provided and/or suitable for receiving a disinfection cap 30 (see Fig. 4) of the third line 60, in particular a used or untouched disinfection cap 30 of a patient connector 61. This is also described in more detail in connection with Fig. 4.
  • the control or regulating device 100 can be configured to initiate the actuation of the automatic hose clamps 40b, 50b, 60b. In some embodiments, this can be effected 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 modes of operation can also be encompassed by the present invention, independently of one another, complementing one another, or replacing one another, 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 (not shown in Fig. 1, please see Fig. 6), pressure sensor 84, turbidity sensor 85, barcode scanner 86, QR code scanner, RFID scanner, temperature meter 87, glucose meter 88, conductivity sensor 89.
  • At least two such sensors can, in some embodiments, form an optional multi-sensor block 90, e.g. with the sensors 84, 85, 86, 87, 88, 89, for example arranged in a row, e.g. all within reach of, i.e. with access to, a measuring chamber 55 (or its contents) of the Y-piece 45 or in the vicinity of or in contact with it (for further details, please see the description of Fig. 2 and Fig. 4).
  • the sensors 84, 85, 86, 87, 88, 89 for example arranged in a row, e.g. all within reach of, i.e. with access to, a measuring chamber 55 (or its contents) of the Y-piece 45 or in the vicinity of or in contact with it (for further details, please see the description of Fig. 2 and Fig. 4).
  • a communication device 93 may 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.
  • 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, again) empty the first, second and/or third line 40, 50, 50.
  • the first reusable unit 10 may comprise at least one battery or accumulator 70, as well as the connectors or connections necessary for proper use thereof, e.g., for charging them.
  • Fig. 2 shows a disposable 20 for connection to a system according to the invention (see Fig. 4) in an exemplary embodiment.
  • the disposable 20 comprises a first line 40 for conducting fresh dialysis fluid from a dialysis fluid source or a bag (not shown in Fig. 2, see Fig. 6) to, for example, a Y-piece 45 or a connector, which is preferably also comprised by the disposable 20.
  • the disposable 20 further comprises a second line 50 for conducting used dialysis fluid, also referred to herein as dialysate, away from the Y-piece 45 or connector towards a drain or a collection bag 51 (not shown in Fig. 2, please see Fig. 6).
  • the Y-piece 45 is in fluid connection or connected to a third line 60, which is also comprised by the disposable 20.
  • the third line 60 is provided and/or suitable for directly or indirectly conducting fresh dialysis fluid from or through the organizer 1, in particular away from the Y-piece 45, towards a patient P (not shown in Fig. 2, please see Fig. 6), and dialysate away from the patient P towards or through the organizer 1, in particular towards the Y-piece 45.
  • the section of the third line 60 can also be referred to as the 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.
  • the measuring chamber 55 or the measuring area can be an integrated cuvette-like coupling area for non-invasive sensors, for example arranged in the multi-sensor block 90 as described herein.
  • the measuring chamber may have a boundary or edge 55a for easy handling.
  • the Y-piece 45 may have at its end, which points in the direction of the third line 60, a first connector section 47, preferably a first screw connection, in order to connect it to a corresponding second connector section 49, which preferably serves as a receiving section which preferably encloses the lumen concentrically.
  • the disposable 20 optionally comprises a self-sealing and/or self-actuating or inserting mechanism, here exemplified by a sealing pin 63.
  • a sealing pin 63 This section of the disposable 20 is shown in an exploded view for better understanding.
  • the sealing pin 63 is designed to fit at the end of the third line 60 facing 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 boundary or edge 61a, particularly for easier handling.
  • the sealing pin 63 optionally comprises an elongated body with a protruding thread which generates a lumen which allows fluid to be passed through the first connector portion 47 and the second connector portion 49 when these portions are connected together.
  • the protruding thread of the sealing pin 63 can be connected to a threaded portion on the inside of the first connector portion 47.
  • the thread pitch of the internal thread for connecting the first connector portion 47 to the sealing pin 63 and the thread pitch of the external thread for connecting the first connector portion 47 to the third line 60 preferably differ from one another.
  • the sealing pin 63, or leak pin or anti-leak pin, is preferably arranged within the lumen of the first connector portion 47 to allow fluid to flow through and/or around the sealing pin 63 through the first connector portion 47.
  • first limiting element preferably in the form of a toothed block, which limits the rotation of the sealing pin 63 in one direction when it is in connected or positive connection to a second limiting element within the lumen of the second connector portion 49.
  • a second limiting element may be configured as a plurality of ribs which extend axially along the inside of the wall of the lumen of the second connector portion 49.
  • the sealing pin 63 preferably has a fastening element with which the sealing pin 63 can be fixed detachably or non-detachably to a closure element, preferably by means of a snap-in connection and/or an undercut.
  • sealing pin 63 When the sealing pin 63 is disposed in the lumen of the second connector portion 49, it allows fluid to flow through or along the sealing pin 63 and through or along the lumen of the second connector portion 49.
  • the sealing pin 63 is arranged in the common lumen, which is formed by the lumens of the first and second connector sections 47, 49, wherein the sealing pin 63 is movable by means of a relative movement of the first connector section 47 to the second connector section 49 between an open position in which the sealing pin 63 which allows the flow of a fluid through the common lumen and a closed position in which the sealing pin 63 blocks the flow of the fluid.
  • 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.
  • Each of the first, second and/or third lines 40, 50, 60 independently optionally includes a manual hose clamp 40a, 50a, 60a.
  • a breaking or predetermined breaking device 33 which must be broken, or any other element that must be manipulated before the first use of the disposable 20, can optionally be provided in the, preferably first, line 40.
  • This arrangement can be advantageously used for treatments within the framework of continuous ambulatory peritoneal dialysis (CAPD).
  • CAPD continuous ambulatory peritoneal dialysis
  • Fig. 3 shows a second disposable 20 for connection to a system according to the invention in a further exemplary embodiment.
  • the first line 40 can be provided and/or suitable for conducting both fresh dialysis fluid from a dialysis fluid source 41 (see Fig. 6) in the direction of the Y-piece 45 and dialysate away from the Y-piece in the direction of an outflow 51 (see Fig. 6) or an optional cycler.
  • Fig. 4 shows the system according to the invention of Fig. 1 and the disposable 20 of Fig. 2 in a connected state. Reference is made to the reference numerals and descriptions of the preceding figures. Some of the reference numerals have been omitted for clarity.
  • the first line 40 is received in the first connection point 11 of the first reusable unit 10, the second line 50 in the second connection point 12 and the third line 60 in the third connection point 13.
  • the Y-piece 45 is connected to the third line 60, ie its measuring chamber 55, in 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 for Fig. 1.
  • 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 the control or regulating device 100.
  • the automatic tube clamp 40b on the first line 40 and the automatic tube clamp 60b on the third line can be opened while simultaneously keeping the automatic tube clamp 50b closed in order to fill the abdominal cavity of the patient P (not shown in Fig. 4) with fresh dialysis fluid from a dialysis fluid source 41 (see Fig. 6).
  • the intraperitoneal pressure (IPP) can be measured, e.g., using the pressure gauge 84 on the third (patient) line 60.
  • the automatic tube clamp 60b on the third line 60 and the automatic tube clamp 50b on the second line 50 for the initial and immediate drainage of the abdominal cavity of the patient P can be opened until the drainage is complete.
  • the completion of the drainage can be monitored, for example, using an electronic scale 83 (see Fig. 6).
  • the signaling devices 80 may be provided to indicate the state of the automatic hose clamps 40b, 50b, 60b, i.e., whether they are open or closed. For example, they may change color for this purpose, e.g., red for closed, green for open. Other light signals, e.g., flashing, on/off, etc., may also be encompassed by the present invention.
  • a used or untouched disinfection cap 30 which is not required during the treatment of the patient P can be picked up from or at the fifth connection point 15 of the first reusable unit 10.
  • the light emitter 110 is indicated in an upper, central section of the base body.
  • the control and regulating device 100 can cause the light emitter 110 (see Fig. 4) to emit light in the direction of the receptacle(s) or the disposable held therein, particularly before and/or during the treatment of a patient P (not shown in Fig. 4, see Fig. 6).
  • Optical sensors 113 are arranged in the housing, for example, near the light emitter 19 or along the third line, for example, in 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, by the sealing pin 63 or other surfaces, can be detected.
  • An exemplary light beam is shown in Fig. 4 as a thin dotted arrow.
  • Fig. 5 shows the system according to the invention of the preceding figures in a sectional view from the side.
  • the design of the second connection point 12 as a groove with a connected second line 50 accommodated therein can be seen in Fig. 5.
  • the control or regulating device 100 is enclosed within the first reusable unit 10, particularly in 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 symbolically represents any charging device known in the art, e.g., inductive or similar.
  • the flow meter 81 and the meters or sensors 84, 85, 86, 87, 88, 89 (not explicitly shown in Fig. 5) of the optional multi-sensor block 90 are located adjacent to the measuring chamber 55 of the third conduit 60 to collect data as described herein.
  • the light emitter 110 is only indicated by dashed lines. Of the optical sensors 113, only the one arranged along the third line, for example in the fourth connection point 14, is visible in the example of Fig. 5, in order to measure the light emitted by the light emitter 110 and to be able to detect subsequently reflected/scattered light (as described herein).
  • Fig. 6 shows a system according to the invention in a highly simplified representation during the treatment of a patient.
  • 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 Fig. 6, dialysis, in particular peritoneal dialysis.
  • a medical treatment in the example of Fig. 6, dialysis, in particular peritoneal dialysis.
  • This type of treatment is indicated by the third line 60 of a disposable 20, here a tubing set (see Fig. 2), which carries fluid to and from the abdominal cavity of a patient P.
  • the system according to the invention comprises the base body, shown here as organizer 1, designed as an example as described in the preceding figures, although shown in Fig. 6 only very schematically by means of its outer contour.
  • the control and regulation device 100 can cause the light emitter 110 (not shown in Fig. 6, see Fig. 4) to emit light in the direction of the receptacle(s) or the disposable received therein.
  • the control or regulating device 100 may be configured to perform a treatment of the patient P, or portions thereof, to control and/or monitor.
  • the control or regulating device 100 can be configured in some embodiments to cause the light to be emitted during a time or period of time that lies during the treatment of the patient P.
  • control or regulating device 100 can be configured to initiate the emission of light by means of the light emitter 110 in order to determine therapy-relevant parameters. Additionally or alternatively, it can control and/or further monitor the treatment of the patient P, or sections thereof, based on these determined parameters.
  • the light emitter 110 may be further configured to emit light for disinfecting surfaces, for example the sealing pin 63 (see Fig. 4).
  • this light may be suitable and/or intended to inactivate or attenuate infectious material, in particular bacteria, fungi, spores and/or viruses.
  • the light emitter 110 can have at least one LED for the aforementioned purposes, it can be suitable and/or intended 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/cm 2 and 1 kJ/cm 2 and 0.005 mW and 1 watt.
  • the control or regulating device 100 can be further configured to emit light with at least one wavelength of electromagnetic radiation selected from a group of wavelengths as the main wavelength in order to disinfect the disposable from one or more target organisms or pathogens.
  • control or regulating device 100 can additionally be configured to allow the main wavelength of the light emitted by the light emitter 110 to alternate between a first main wavelength and a second main wavelength, which differs from the first main wavelength, following a selected or predetermined pattern.
  • the control or regulating device 100 may be further configured to cause the light emitter 110 to transmit the electromagnetic radiation in a pulsed manner in order to improve the elimination of the pathogens, wherein the pulse width modulation is preferably at a frequency of 100 Hz to 10 kHz, preferably at most 1000 Hz.
  • 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 explained in Fig. 4.
  • the first line 40 carries fresh dialysis fluid from a dialysis fluid source or bag 41 to or through the organizer 1 via or along the third line 60 towards the patient, preferably without using any conveying means, i.e. driven only by gravity.
  • any conveying means i.e. driven only by gravity.
  • used dialysis fluid ie dialysate
  • a drain or a collecting bag 51 preferably also driven by gravity.
  • the flow through the lines 40, 50, 60 may be controlled by a control or regulating device 100 (see Fig. 1) configured to control the automatic hose clamps 40b, 50b, 60b (see Fig. 1), for example as described elsewhere herein.
  • the system may further comprise at least one electronic scale 83 for balancing the treatment fluids.
  • the scale 83 is preferably battery-operated.
  • a scale 83 is arranged which weighs both the dialysis fluid source, implemented here as bag 41, and the effluent, also implemented here as a (collection) bag 51, e.g., to determine the end of the treatment or to monitor its implementation.
  • the organizer 1 can be battery-operated, for example by means of a rechargeable battery, e.g. as described in Fig. 5.
  • the organizer 1 can support wireless bidirectional communication with an independent external communication device 95, shown in Fig. 6 by means of a smartphone, tablet or the like, e.g. via Bluetooth, Wi-Fi or the like.
  • the external communication device 95 can function as a data gateway.
  • the secure and efficient communication between the organizer 1, other external devices, e.g., the battery-operated electronic or digital scale 83, heating devices, blood pressure monitor, etc., and the external communication device 95 is established and managed by means of a dedicated application (app for short), e.g., as part of a comprehensive patient app or a facility-specific app.
  • the external communication device 95 functions here as a data gateway and provides all modern/current security and data protection measures offered by modern smartphones or tablets.
  • User and/or patient identification and the assignment of data can preferably also be provided by means of the external communication device 95, for example realized 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 using the proven devices/equipment for external communication from the prior art.
  • biometric recognition e.g. facial recognition or a fingerprint sensor
  • a personalized code e.g. a personalized code
  • the control or regulating device 100 of the organizer 1 may be configured in some embodiments to transmit of status information (e.g. terminal open or closed, battery charge level, error codes, time stamp, 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 the external communication device 95.
  • status information e.g. terminal open or closed, battery charge level, error codes, time stamp, etc.
  • the external communication unit 95 can itself be connected 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 certain procedures for preparation, treatment, measurement, calibration, or status changes. Using these procedures, the entire peritoneal dialysis (PD) therapy is digitized, documented, stored, analyzed, and controlled.
  • 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 certain procedures for preparation, treatment, measurement, calibration, or status changes.
  • PD peritoneal dialysis

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  • Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Emergency Medicine (AREA)
  • Anesthesiology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un système de traitement médical, de préférence pour le traitement par dialyse d'un patient (P), en particulier pour le traitement au moyen d'une dialyse péritonéale, comprenant un corps principal, en particulier un organiseur (1), ayant des points de liaison (11, 12, 13, 14) pour un article jetable et un émetteur de lumière (110) destiné à émettre de la lumière, en particulier pour inactiver des pathogènes infectieux. L'invention concerne en outre une procédé de préparation ou de réglage d'un système selon l'invention.
PCT/EP2025/059982 2024-04-18 2025-04-11 Système de dialyse péritonéale avec émetteur de lumière Pending WO2025219229A1 (fr)

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DE102024110933.5A DE102024110933A1 (de) 2024-04-18 2024-04-18 System zur Peritonealdialyse mit Lichtemitter
DE102024110933.5 2024-04-18

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WO2025219229A1 true WO2025219229A1 (fr) 2025-10-23

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WO2013159935A1 (fr) 2012-04-26 2013-10-31 Fresenius Medical Care Deutschland Gmbh Électrodes pour un dispositif de mesure de bio-impédance, et dispositifs utilisés pendant une dialyse
US20140334974A1 (en) * 2013-01-29 2014-11-13 Puracath Medical, Inc. Apparatus for disinfecting or sterilizing a catheter and method of use
CN107126590A (zh) * 2016-02-26 2017-09-05 百特（中国）投资有限公司 腹膜透析装置
US20180071445A1 (en) * 2015-05-19 2018-03-15 Nikkiso Company Limited Dialysate-extracting apparatus
WO2019118929A1 (fr) * 2017-12-15 2019-06-20 Gastroklenz Inc. Système de surveillance de capteur pour traitements à base de cathéter à demeure
DE102018113322A1 (de) 2018-06-05 2019-12-05 Fresenius Medical Care Deutschland Gmbh Organizer für die Peritonealdialyse und medizinisches System
WO2021043737A1 (fr) 2019-09-05 2021-03-11 Fresenius Medical Care Deutschland Gmbh Raccord médical à étanchéité automatique lors du débranchement
WO2024059030A1 (fr) * 2022-09-14 2024-03-21 Baxter International Inc. Système de dialyse ayant un nettoyage de surface externe de tube

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US8197087B2 (en) * 2007-07-05 2012-06-12 Baxter International Inc. Peritoneal dialysis patient connection system using ultraviolet light emitting diodes
EP3946475B1 (fr) * 2019-03-25 2024-05-01 Light Line Medical, Inc. Appareil d'administration d'un rayonnement thérapeutique, électromagnétique non ultraviolet de manière polyvalente par l'intermédiaire d'un cathéter résidant dans une cavité corporelle

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013159935A1 (fr) 2012-04-26 2013-10-31 Fresenius Medical Care Deutschland Gmbh Électrodes pour un dispositif de mesure de bio-impédance, et dispositifs utilisés pendant une dialyse
US20140334974A1 (en) * 2013-01-29 2014-11-13 Puracath Medical, Inc. Apparatus for disinfecting or sterilizing a catheter and method of use
US20180071445A1 (en) * 2015-05-19 2018-03-15 Nikkiso Company Limited Dialysate-extracting apparatus
CN107126590A (zh) * 2016-02-26 2017-09-05 百特（中国）投资有限公司 腹膜透析装置
WO2019118929A1 (fr) * 2017-12-15 2019-06-20 Gastroklenz Inc. Système de surveillance de capteur pour traitements à base de cathéter à demeure
DE102018113322A1 (de) 2018-06-05 2019-12-05 Fresenius Medical Care Deutschland Gmbh Organizer für die Peritonealdialyse und medizinisches System
WO2021043737A1 (fr) 2019-09-05 2021-03-11 Fresenius Medical Care Deutschland Gmbh Raccord médical à étanchéité automatique lors du débranchement
WO2024059030A1 (fr) * 2022-09-14 2024-03-21 Baxter International Inc. Système de dialyse ayant un nettoyage de surface externe de tube

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