PERITONEAL DIALYSIS DEVICE

Description

[0001] The invention relates to a device for performing peritoneal dialysis treatment on a patient.

[0002] Peritoneal dialysis (PD) is also known as peritoneal dialysis. There are various PD procedures, including automated peritoneal dialysis (APO) procedures performed with peritoneal dialysis machines. In APO, all or at least some of the treatment steps are performed automatically. These can include, for example, turning pumps on or off, opening or closing valves, etc.

[0003] The flow of dialysis solution can be effected gravimetrically, ie by gravity, and / or by means of one or more pumps.

[0004] The present invention is not limited to any particular type of PD, ie it includes automatic, non-automatic, gravimetric and pump-operated devices.

[0005] In PD, the device delivers a dialysis solution into the patient's abdominal cavity via a catheter, for example automatically using a pump or gravimetrically during an enema phase.

[0006] The dialysis solution is then left in the abdominal cavity for a holding period. This allows small-molecular substances from the blood to pass into the dialysis solution via the capillaries of the peritoneum, due to a concentration gradient. Furthermore, water can be removed from the body in this way if the dialysis solution contains a higher content of osmotically active substances than the blood. At the end of the holding period, the device removes the used dialysis solution, enriched with excreted substances, from the abdominal cavity via the catheter in a drainage phase. The fluid exchange can be performed gravimetrically or actively using a pump.

[0007] The cycle of run-in, hold, and drain phases is repeated several times during typical procedures, for example, at night while the patient is asleep. A new run-in phase is initiated whenever the device detects that the drain phase is complete, i.e., that the used dialysis fluid has completely or partially drained from the patient's abdominal cavity.

[0008] Currently known peritoneal dialysis machines determine whether a drainage phase has ended and a new run-in phase can begin purely based on criteria that normally occur at the end of the drainage phase, such as the minimum drainage volume being reached and the flow rate falling below a certain level. In this case, disruptions in the drainage process, which may arise from an unintentional kink in the drainage tube, may not be detected, meaning that the drainage phase is aborted prematurely and the subsequent run-in phase starts too early. In the interest of the most efficient treatment possible, however, it is desirable that the used dialysis solution is removed as completely as possible from the abdominal cavity in each drainage phase in order to ensure the largest possible exchange volume. A dialysis system is known, for example, from US2009012455A1. WO2013 / 141896A1 discloses a known peritoneal dialysis system.

[0009] The object of the invention is to provide a peritoneal dialysis machine with which the progress of the process or the actual end of the process phase can be detected more reliably.

[0010] Against this background, the invention relates to a peritoneal dialysis machine, preferably for carrying out an automated peritoneal dialysis treatment with repeating cycles, the cycles comprising a run-in phase, a holding period, and a run-off phase for the dialysis fluid, wherein the machine has a control unit and a measuring device for determining the inflow and / or outflow rate of the dialysis fluid from a patient. According to the invention, it is provided that the control unit is designed to compare a temporal curve of the inflow and / or outflow rate during a run-in and / or run-off phase, determined by the measuring device, with a corresponding reference curve and, on the basis of this comparison, to detect a disturbance in the inflow and / or outflow of the dialysis fluid to or from the patient.

[0011] Preferably, the device is designed in such a way that the inlet and outlet are automated by means of a control unit of the device.

[0012] It can be provided that a reference curve for the temporal progression of the outflow rate during the inflow and / or outflow phase is stored in the control unit, with which a measured reference curve is compared. Based on this comparison, an atypical temporal progression of the inflow and / or outflow rate can be detected, which indicates a disturbance in the inflow and / or outflow phase. On this basis, for example, the accuracy of detecting whether the entire or desired amount of dialysis fluid has actually drained from the patient can be improved. Furthermore, countermeasures can be initiated in the event of a disturbance.

[0013] The present invention preferably relates to actively pumping APO devices, i.e., peritoneal dialysis devices in which the inflow and / or outflow of the dialysis solution into / from the patient is effected by means of one or more pumps, as well as gravimetric peritoneal dialysis devices in which said inflow and / or outflow occurs by gravity and without pumps. In both cases, the control of the fluid flows is preferably automated, e.g., by opening and closing valves, etc.

[0014] According to the invention, the control unit is designed such that when a disturbance in the outflow of the dialysis fluid from the patient is detected, a time-limited observation phase is started during which the outflow rate is measured and checked to see whether a minimum flow is reached again. In this embodiment, the system waits to see whether a minimum flow is reached again, for example because a kink in the catheter or tube clears up by movement of the patient. If the desired minimum flow is not reached again during the observation phase, which can last between 1 and 5 minutes, for example, further measures can be provided. The minimum flow can, for example, correspond to the flow that would be provided for in the reference curve at a specific time during the outflow phase, corrected if necessary by a tolerance discount.

[0015] In one embodiment, the control unit is designed such that, upon detection of a disruption in the flow of dialysis fluid from the patient, a volume is pumped toward the patient. This measure can be used to check the quality of the line. The pumping can be performed actively, for example, using a fluid pump. This measure can be initiated after an observation phase, if one is provided for.

[0016] In one embodiment, the control unit is designed such that a signal is output upon detection of a fault in the inlet and / or outlet of the dialysis fluid to or from the patient.

[0017] For this purpose, the device may be provided with a signaling unit or an interface for communication with an external signaling unit. The signal output may represent an attempt to improve the situation. For example, the signal may serve to wake or stimulate the patient, or to draw their attention to the need to move or actively restart the catheter. Suitable signals include, for example, optical signals, audible signals, or vibration signals. The measure may, if necessary, be taken after an observation phase and / or after a volume has been delivered to the patient, provided such measures are provided for.

[0018] In one embodiment, the control unit is configured to optimize the device configuration based on the comparison. For example, criteria for determining when a sequence phase is considered complete can be adapted to a patient based on the reference curve and the measured curve.

[0019] In one embodiment, the reference curve is a patient-independent function stored in the control unit. The reference curve can, for example, be defined schematically based on prescription parameters, such as the amount of fluid administered.

[0020] In one embodiment, the reference curve is a patient-specific function. For example, it can be provided that a reference curve is recorded in a setting cycle before the start of treatment. Furthermore, it can be provided, for example, that the reference curve is determined from a plurality of measured curves, e.g., by averaging. The reference curve can be formed by superimposing curves measured in a certain number of previous cycles or treatments; thus, it can be a patient-specific average.

[0021] In one embodiment, the device is a gravimetric device. For example, one or more valves can be provided, and the control unit can be configured such that the valve(s) is opened after the holding phase and before the start of the drain phase to allow gravimetric drainage of dialysis fluid from the patient, and / or that the valve(s) is opened after the drain phase and before the start of the fill phase to allow gravimetric inflow of dialysis fluid to the patient.

[0022] In one embodiment, the device is an actively pumping device. For example, one or more pumps can be provided, and the control unit can be configured to withdraw dialysis fluid from the patient during the drain phase using one or more pumps and / or to supply dialysis fluid to the patient during the run-in phase using one or more pumps.

[0023] The invention further encompasses a method for performing peritoneal dialysis using a peritoneal dialysis machine according to the invention, wherein a comparison is made between a measured temporal curve of the inflow and / or outflow rate during an inflow and / or outflow phase and a corresponding reference curve, and wherein, based on this comparison, a disturbance in the inflow and / or outflow of the dialysis fluid to or from the patient is detected. Advantageous embodiments of the method emerge from the above description of the design of the control unit in the peritoneal dialysis system according to the invention.

[0024] Further details and advantages of the invention will become apparent from the exemplary embodiment explained below with reference to the figure. The single figure shows possible temporal progressions of the outflow rate (volume / time) in the abdominal cavity during the outflow phase with gravimetric, i.e., passive outflow.

[0025] According to the exemplary embodiment, a peritoneal dialysis machine is provided which is designed for performing an automated peritoneal dialysis treatment with repetitive cycles comprising a run-in phase, a holding period, and a drain phase for the dialysis fluid. The machine 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 dialysate pump for delivering dialysis fluid to the patient, as well as a drain valve which is opened by the control unit after the hold phase and before the start of the drain phase to enable a gravimetric drain of dialysis fluid from the patient.

[0026] A reference curve for the temporal progression of the outflow phase is stored in the memory of the control unit, for example. This reference curve is patient-specific and was created by superimposing curves measured during processes in a certain number of previous cycles. Furthermore, an algorithm is stored on the control unit that allows a comparison to be made between a temporal progression curve of the outflow rate determined by the measuring device during a subsequent outflow phase and the reference curve. The algorithm also allows for the detection of any disturbance in the outflow of dialysis fluid from the patient based on this comparison.

[0027] Instead of a memory that is physically located in the device, the memory can also be located on a movable object, such as a patient card, or another data storage device that is not part of the device.

[0028] If a fault is detected, the control unit is trained to take a series of measures.

[0029] First, a specific observation phase, for example, three minutes, is initiated, during which the discharge rate is continuously measured and checked for a minimum flow rate. The minimum flow rate corresponds to the flow rate that should have existed before the disturbance occurred, minus a specific tolerance interval, for example, 30%.

[0030] If the minimum flow is not reached again during the observation phase, the control unit starts the dialysate pump to deliver a specific, smaller volume, for example, 100 ml, to the patient. This measure can be used to check the quality of the line.

[0031] The above numerical values ​​are examples and do not limit the invention.

[0032] Alternatively or additionally, a warning signal, preferably an acoustic signal, can be issued.

[0033] If a malfunction is detected during this filling test, for example, a kink in the catheter, the control unit emits an acoustic signal via a signal unit built into the device. This signal is intended to wake the patient and alert them to change their position.

[0034] After this step, a re-evaluation takes place in the form of a new observation phase and a new filling test. The signaling can also be repeated in the same or more intensive form, so that the patient may then actually get up to check the function of the lines.

[0035] The "reference" curve in the figure shows a temporal progression of the outflow rate in a device according to the exemplary embodiment under normal conditions. The outflow rate decreases as the patient empties more rapidly and the hydrostatic pressure decreases. This time period can be, for example, 5 minutes.

[0036] The "Disturbance 1" curve in the figure shows a temporal progression of the outflow rate in the event that the outflow is disrupted shortly before the end of the drainage phase. This can occur, for example, if the drainage catheter sags or is otherwise blocked or clamped / kinked, so that further drainage no longer occurs when a certain hydrostatic pressure is exceeded.

[0037] Finally, the "Disturbance 2" curve in the figure shows a temporal progression of the outflow rate in the event that the outflow is disrupted somewhat earlier. This can occur, for example, if the drainage catheter is kinked by a patient's movement during sleep or otherwise blocked, such as becoming clogged, so that further drainage no longer occurs when a certain hydrostatic pressure is exceeded.

[0038] Advantages of the inventive solution include, for example, avoiding premature switching from a run-down phase to the run-up phase of the subsequent cycle, as well as an overall improvement in the run-down behavior and thus an optimization of the therapy. The number of unjustified or unintentionally terminated run-down phases can be reduced. There are also fewer opportunities for the user to negatively influence the device's behavior. The patient receives improved feedback, for example, regarding their sleeping position, bed height, or the location of the device.

Claims

1. A peritoneal dialysis machine for the carrying out of a peritoneal dialysis treatment having recurring cycles, the cycles comprising an inflow phase, a dwell period and a drainage phase for the dialysis fluid, wherein the machine has a control unit and a measurement apparatus for determining the inflow and / or drainage rate of the dialysis fluid to and from a patient, characterized in that the control unit is configured to carry out a comparison between a time progression curve of the inflow rate and / or of the drainage rate determined by the measurement apparatus during an inflow phase and / or a drainage phase and a corresponding reference curve and to recognize on the basis of this comparison a disturbance in the inflow and / or drainage of the dialysis fluid to and from the patient; and in that the control unit is configured such that, on a recognition of a disturbance in the drainage of the dialysis fluid from the patient and / or on a recognition of a disturbance in the inflow of dialysis fluid to the patient, a time-limited observation phase is started during which the drainage rate or the inflow rate is measured and a check is made with respect to the re-reaching of a flow or of a minimal flow.

2. A peritoneal dialysis machine in accordance with one of the preceding claims, characterized in that the control unit is configured such that, on a recognition of a disturbance in the drainage of the dialysis fluid from the patient, a volume is conveyed in the direction of the patient.

3. A peritoneal dialysis machine in accordance with one of the preceding claims, characterized in that the control unit is configured such that a signal is output on a recognition of a disturbance in the inflow and / or drainage of the dialysis fluid to or from the patient.

4. A peritoneal dialysis machine in accordance with claim 3, characterized in that the signal is a visual signal, an acoustic signal or a vibration signal.

5. A peritoneal dialysis machine in accordance with one of the preceding claims, characterized in that the control unit is configured such that an optimization of the machine configuration is carried out on the basis of the comparison.

6. A peritoneal dialysis machine in accordance with one of the preceding claims, characterized in that the reference curve is a patient-independent function that is stored in the control unit.

7. A peritoneal dialysis machine in accordance with one of the claims 1 to 5, characterized in that the reference curve is a patient-individual function.

8. A peritoneal dialysis machine in accordance with one of the preceding claims, characterized in that the machine is a gravimetrically working machine.

9. A peritoneal dialysis machine in accordance with one of the claims 1 to 7, characterized in that the machine is an actively conveying machine.