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
  • A61M1/28—Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
  • A61M1/287—Dialysates therefor
• • 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
  • A61M2205/18—General characteristics of the apparatus with alarm
• • 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
  • A61M2205/3331—Pressure; Flow
  • A61M2205/3334—Measuring or controlling the flow rate
• • 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
  • A61M2205/70—General characteristics of the apparatus with testing or calibration facilities

Definitions

• the invention relates to a device for performing a peritoneal dialysis treatment on a patient.
• Peritoneal dialysis is also known as peritoneal dialysis.
• PD techniques including automated peritoneal dialysis (APO) procedures using peritoneal dialysis machines.
• APO automated peritoneal dialysis
• all or at least some of the treatment steps are automated. This can be, for example, the switching on or off of pumps, the opening or closing of valves, etc.
• the effect of causing a flow of dialysis solution may be gravimetric, i. by gravity, and / or by means of one or more pumps.
• the present invention is not limited to any particular type of PD, ie, includes both automatic, non-automatic, gravimetric, and pump-powered devices.
• the device leads the patient, for example, automatically through a pump or gravimetrically in a run-in phase via a catheter, a dialysis solution into the abdominal cavity.
• the dialysis solution is then left in the abdominal cavity during a holding period.
• small molecular substances from the blood on the capillaries of the peritoneum can pass into the dialysis solution, as there is a concentration gradient, also the body can be removed in this way, water, if the dialysis solution has a higher content of osmotically active substances than the blood.
• the device removes the dialysis solution enriched with excreted substances and thus consumed again in a discharge phase via the catheter from the abdominal cavity.
• the liquid exchange can be done gravimetrically or actively by means of a pump.
• a new break-in phase is started whenever the device determines that the drainage phase has ended, that is, that the spent dialysis fluid has completely or partially drained from the abdominal cavity of the patient.
• Dialysis solution is as completely as possible removed from the abdominal cavity to ensure the largest possible exchange volumes.
• the object of the invention is to provide a peritoneal dialysis device with which the progress of the process or the actual end of the process phase can be detected more reliably.
• the invention relates to a peritoneal dialysis machine, preferably for carrying out an automated peritoneal dialysis treatment with repetitive cycles, the cycles comprising an inlet phase, a holding period and a drainage phase for the dialysis fluid, wherein the device comprises a control unit and a measuring device for determining the inlet and / or discharge rate of the dialysis fluid from a patient.
• control unit is designed to make a comparison between a time curve of the inlet and / or outflow rate determined by the measuring device during a run-in and / or run-down phase with a corresponding reference curve and, based on this comparison, a fault in the run-in and / or expiry of the dialysis fluid to or from the patient.
• the device is designed such that the inlet and the drain are automated by means of a control unit of the device.
• a reference curve for the time profile of the outflow rate during the run-in and / or run-down phase is stored in the control unit, with which a measured comparison curve is compared.
• an atypical time profile of the inlet and / or outflow rate can be detected, which indicates a disturbance in the inlet and / or outlet phase.
• the recognition accuracy can be improved, whether really the whole or the desired amount of the dialysis fluid has expired from the patient.
• countermeasures can be initiated in the event of a fault.
• the present invention preferably relates to actively-promoting EPO devices, i. Peritoneal dialysis machines in which the inlet and / or the drainage of the dialysis solution in / from the patient by means of one or more pumps, as well as gravimetrically operating peritoneal dialysis machines, in which said inlet and / or outlet by means of gravity and without pumps erfoigt.
• the control of the fluid flows in both cases is preferably automated, e.g. by opening and closing valves etc.
• control unit is designed so that upon detection of a disturbance in the course of the dialysis fluid from the patient, a time-limited observation phase is started, during which of the
• Outflow rate is measured and checked for the Wiedererich a Minimelfiusses. It is thus waited in this embodiment, whether again adjusts an iVlinimaifiuss, for example, because a kink in the catheter or in the hose dissolves by movement of the patient by itself again. If, during the observation phase, which can last, for example, between 1 and 5 minutes, the aspired IVlinimaifiuss not reached again, further measures can be provided.
• the iVlinimaifiuss for example, correspond to the flow that would be provided in the reference curve at a certain time of the Abiaufphase, possibly corrected by a tolerance deduction.
• control unit is designed such that upon detection of a disturbance in the course of the dialysis fluid from the patient, a volume is conveyed in the direction of the patient. Based on this measure, the quality of the line can be checked. The promotion can for example be done actively by means of a fluid pump. The measure may, if appropriate, be taken after the end of an observation phase, if such is provided for. In one embodiment, it is provided that the control unit is designed so that upon detection of a fault in the inlet and / or outlet of the dialysis fluid to or from the patient a Signa! is issued.
• the device has a signal unit or an interface for communication with an external signal unit.
• the signal output may be an attempt to improve the situation.
• the signal may be used to wake or stimulate the patient, or to alert them to move or actively re-start the catheter.
• Suitable signals include, for example, optical signals, audio signals or vibration signals.
• the measure may optionally be taken after the expiry of an observation phase and / or after a volume has been conveyed in the direction of the patient, provided that such measures are provided, in one embodiment it is provided that the control unit is designed such that on the basis of the comparison an optimization of the Device configuration is made.
• criteria as to when a sequence phase should be regarded as terminated can be adapted to a patient in accordance with the reference curve and the measured curve.
• the reference curve is a patient-independent function that is stored in the control unit.
• the reference curve can, for example, schematically parameters based on prescribing, such as the 'amount of the administered fluid, are defined.
• the reference curve is a patient-specific function.
• a reference curve is recorded in a setting cycle before the start of treatment.
• the reference curve ve is determined from a plurality of measured curves, for example by averaging.
• the reference curve may be formed by a superposition of curves measured in a certain number of previous cycles or treatments, so it may be a patient-specific mean.
• the device is a gravimetrically operating device.
• one or more valves may be provided and the controller may be configured to open the or a valve after the hold phase and before the start of the drain phase to allow gravimetric drainage of dialysis fluid from the patient and / or the valve or valves the drain phase and before the start of the run-in phase is opened to allow a gravimetric inlet of dialysis fluid to the patient.
• the device is an actively conveying device.
• one or more pumps may be provided, and the control unit may be designed to withdraw dialysis fluid from the patient during the drainage phase and / or to supply dialysis fluid to the patient during or by means of the pump.
• the invention comprises a method for performing a peritoneal dialysis using a peritoneal dialysis apparatus according to the invention, wherein a comparison between a measured time course curve of the inlet and / or outflow rate during an inlet and / or Abiaufphase is made with a corresponding reference curve, and wherein on Basis of this comparison is a disturbance in the inlet and / or outlet of the dialysis fluid to or recognized by the patient.
• Advantageous embodiments of the method will become apparent from the above description of the configuration of the control unit in per se invention perigeeadiavsencing Further details and advantages of the invention will become apparent from the following explained with reference to the figure embodiment.
• the single figure shows possible temporal courses of the outflow rate (volume / time) in the abdominal cavity during the expiration phase with gravimetric, ie, passive Abiauf.
• a peritoneal dialysis machine intended for performing automated peri-oral dialysis treatment with repetitive cycles comprising an inflow phase, a hold period, and a dialysis fluid drainage phase.
• the device comprises a control unit and a measuring device for determining the inflow and / or outflow rate of the dialysis fluid from a patient. It further comprises a dialysis pump for delivering dialysis fluid to the patient, and a drain valve which is opened by the control unit after the holding phase and before the start of the expiration phase to allow a gravimetric discharge of dialysis fluid from the patient.
• the control unit is a reference curve for the timing of the phase-out phase deposited, which is patient-individual and was formed by a superposition of curves that were used as part of operations in a certain number of previous cycles.
• an algorithm is stored on the control unit, by means of which a comparison between a time profile curve of the outflow rate determined by the measuring device during a further execution phase with the reference curve can be made. The algorithm also makes it possible to detect, on the basis of this comparison, a malfunction in the course of the dialysis fluid from the patient.
• the memory may also be on a moving object, such as on a patient card or any other memory that does not form part of the device. If a fault is detected, the control unit is designed to take a number of measures.
• a certain, for example, three-minute, observation phase is started, in which the outflow rate is continuously measured and checked for the re-achievement of a minimum flow.
• the minimum affinity corresponds to the flow that should be present before the occurrence of the disturbance, minus a specific, for example 30%, tolerance interval.
• control unit blocks the dialysate pump in order to convey a specific, smaller volume of, for example, 100 ml in the direction of the patient. Based on this measure, the quality of the line can be checked.
• a warning signal preferably acoustic information, may be output.
• control unit gives an audible signal to a signal unit installed in the device. out. It should be able to wake the patient and alert them to change his position.
• the signaling can be repeated in the same or more intensive form that the patient may actually stand up to check the function of the lines.
• the curve "reference" of the figure shows a temporal progression of the outflow rate in a device according to the exemplary embodiment in the normative case The outflow rate decreases due to the increasing emptying of the patient due to the decreasing hydrostatic pressure.
• the "fault 1" curve of the figure shows a time course of the drainage rate in the event that the drain is disturbed shortly before the end of the run-away phase, for example, if the drainage catheter sags or is otherwise plugged or pinched / pinched , so that the further process stops when a certain hydrostatic pressure is exceeded.
• fault 2 shows a time course of the outflow rate in the event that the drain is disturbed a little earlier, for example, when the drainage catheter is kinked or otherwise blocked by a patient's motion during sleep , such as is clogged, so that the further process does not continue when falling below a certain hydrostatic pressure.
• Advantages of the solution according to the invention include, for example, an avoidance of premature switching from a phase-out phase into the inrush phase of the subsequent cycle, as well as an overall improvement in the behavior and hence an optimization of the therapy.
• the number of unauthorized or unintentionally terminated phasing out periods can be reduced.
• the patient receives improved feedback, for example with regard to his sleeping position, the bed height or the location of the device.

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• Health & Medical Sciences (AREA)
• Emergency Medicine (AREA)
• Urology & Nephrology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
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• 2017
  • 2017-05-16 DE DE102017110607.3A patent/DE102017110607A1/de active Pending
• 2018
  • 2018-05-16 JP JP2019563475A patent/JP2020520272A/ja active Pending
  • 2018-05-16 US US16/613,437 patent/US11369723B2/en active Active
  • 2018-05-16 WO PCT/EP2018/062816 patent/WO2018210973A1/de not_active Ceased
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