peritoneal dialysis machine

Abstract

To provide a peritoneal dialysis machine capable of reliably recognizing progress of discharge or real completion of a discharge phase.SOLUTION: The invention relates to a peritoneal dialysis machine for giving a peritoneal dialysis treatment having a circulation cycle including an inflow phase for dialysate, a retention period and a discharge phase. The machine has a control unit and a measuring apparatus for determining inflow speed and / or discharge speed of dialysate to / from a patient. The control unit is configured to compare a time course curve of the inflow speed and / or discharge speed determined by the measuring apparatus during an inflow phase and / or a discharge phase with a corresponding reference curve and to recognize defect in inflow and / or discharge of the dialysate to / from the patient on the basis of the comparison.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a machine for administering peritoneal dialysis treatment to a patient. [Background technology]

[0002] Peritoneal dialysis is also abbreviated as PD. There are various PD processes, including the process of automated peritoneal dialysis (APD), which is performed using a peritoneal dialysis machine. In APD, all or at least some of the treatment steps are performed in an automated manner. The steps can be, for example, turning a pump on or off, opening or closing a valve, etc.

[0003] The dialysate flow can be caused gravitationally, i.e., by gravity, and / or by one or more pumps.

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

[0005] In PD, a machine delivers dialysate to a patient, for example, by a pump through a catheter in an automated manner or by gravity during an inflow phase into the peritoneal cavity.

[0006] The dialysate then remains in the peritoneal cavity during a dwell period. During this process, low-molecular-weight substances can enter the dialysate from the blood through the peritoneal capillaries due to the presence of a concentration gradient. Under conditions where the dialysate has a higher content of osmotically active substances than the blood, water can be removed from the body in this way. After the dwell period ends, the machine removes the exhausted dialysate, enriched with the eliminated substances, from the peritoneal cavity in a drainage phase, again via the catheter. Fluid exchange can be performed by gravity or actively by a pump.

[0007] The cycle of inflow phase, dwell period, and drain phase is repeated multiple times in a typical process control routine, for example, overnight while the patient sleeps. A new induction phase is initiated whenever the machine determines that the drain phase is complete, i.e., the spent dialysate has been completely or partially drained from the patient's peritoneal cavity.

[0008] Currently known peritoneal dialysis machines determine whether the drain phase has ended and can start a new inflow phase simply by referring to the criteria typically used for the end of the drain phase, i.e., the minimum drainage volume reached and a drop below a specific flow rate. In this regard, drainage disturbances resulting from, for example, an unintentional twisting of the drain hose may not be recognized, and thus the drain phase may be prematurely interrupted and the subsequent inflow phase may begin prematurely. However, for the most efficient treatment possible, it is desirable that the spent dialysate be removed as completely as possible from the peritoneal cavity during all drainage phases to ensure the largest possible exchange volume. Summary of the Invention [Problem to be solved by the invention]

[0009] It is an object of the present invention to provide a peritoneal dialysis machine which allows for more reliable recognition of the progress of drainage or the actual end of the drainage phase. [Means for solving the problem]

[0010] Against this background, the present invention relates to a peritoneal dialysis machine for performing automated peritoneal dialysis therapy having a circulation cycle including an inflow phase, a dwell period, and a drain phase for dialysate, the machine comprising a control unit and a measurement device for determining the inflow and / or drain rates of dialysate to and from a patient. According to the invention, the control unit is configured to perform a comparison between time-course curves of the inflow and / or drain rates determined by the measurement device during the inflow and / or drain phase and corresponding reference curves, and to recognize an obstruction in the inflow and / or drainage of dialysate to and from the patient based on this comparison.

[0011] The machine is preferably configured so that inlet and outlet are controlled in an automated manner by the machine's control unit.

[0012] Reference curves of the time course of the discharge rate during the inflow and / or drain phase can be stored in the control unit, and the measured comparison curves can be compared thereto. A typical time course of the inflow and / or drain rate can be recognized with reference to the comparison, and a fault in the inflow or drain phase can be indicated. Based on this, for example, the accuracy of recognition as to whether the total or desired amount of dialysate is actually being drained from the patient can be improved. Countermeasures can also be initiated in the event of a fault.

[0013] The present invention preferably relates to actively pumping APD machines, i.e., peritoneal dialysis machines in which the inflow and / or outflow of dialysate to / from the patient is controlled by one or more pumps, and also to gravity-operated peritoneal dialysis machines in which the designated inflow and / or outflow is controlled by gravity and without a pump. In either case, control of fluid flow is preferably performed in an automated manner, e.g., by open and closed valves, etc.

[0014] In one embodiment, the control unit is configured such that, upon recognition of an obstruction in the drainage of dialysate from the patient, a timed observation phase is initiated during which the drainage rate is measured and checked for re-achievement of the minimum flow rate. This embodiment is thus a wait-and-see approach, whereby the minimum flow rate is also used, for example, due to kinking of the catheter caused by patient movement or its own hose release. If the desired minimum flow rate is also not reached during the observation phase, which may last, for example, 1 to 5 minutes, a further measure can be provided. The minimum flow rate can correspond to the flow rate that would be provided by the reference curve at a specific time during the drainage phase, corrected as needed by, for example, tolerance allowances.

[0015] In one embodiment, the control unit is configured to transport a certain amount in the direction of the patient upon recognition of an obstruction in the drainage of dialysate from the patient. The quality of the line can be checked using this means. Transport can be performed actively, for example by a fluid pump. Measurements can optionally be performed after the observation phase has elapsed, if such a phase is provided.

[0016] In one embodiment, the control unit is configured to output a signal upon recognition of an obstruction in the flow and / or drainage of dialysate to or from the patient.

[0017] For this purpose, the machine is configured with a signal unit or interface for communication with an external signal unit. The signal output can represent an attempt to improve the situation. The signal can, for example, serve to wake or stimulate the patient or to draw the patient's attention to the fact that the patient is moving or similarly to actively set the catheter in an activated state. Suitable signals include, for example, visual, auditory or vibration signals. Measurements can optionally be made after the expiration of an observation phase in which such measures are taken and / or after delivery of a quantity in the direction of the patient.

[0018] In one embodiment, the control unit is adapted to enable optimization of the configuration of the machine based on the comparison, for example, criteria for when the discharge phase is considered to be finished can be adapted to the patient according to the reference curve and the measurement curve.

[0019] In one embodiment, the reference curve is configured to be a patient-independent function stored in the control unit. The reference curve can be roughly fixed using prescribed parameters, such as the amount of fluid administered.

[0020] In one embodiment, the reference curve is configured to be a patient-specific function. For example, the reference curve can be configured to be recorded in a set cycle before the start of treatment. For example, the reference curve can be configured to be determined from multiple measurement curves, for example, by forming an average. The reference curve can be formed by superimposing curves measured in a certain number of previous cycles or treatments, and therefore can be a patient-specific average value.

[0021] In one embodiment, the machine is configured to be a gravity-operated machine. For example, one or more valves can be provided, and the control unit can be configured to open the or each valve after a dwell phase and before the start of a drain phase to allow gravity drainage of dialysate from the patient, and / or to open the or each valve after a drain phase and before the start of an inflow phase to allow gravity inflow of dialysate to the patient.

[0022] In one embodiment, the machine is configured to be an active pumping machine, e.g., one or more pumps may be provided, and the control unit may be configured to use the or each pump to draw dialysate back from the patient during a drain phase and / or use the or each pump to supply dialysate to the patient during an inflow phase.

[0023] The invention further comprises a method for performing peritoneal dialysis using a peritoneal dialysis machine according to the invention, wherein a comparison is made between measured time course curves of the inflow and / or outflow rates during the inflow and / or outflow phases and corresponding reference curves, and disturbances in the inflow and / or outflow of dialysate to or from a patient are recognized on the basis of this comparison. Advantageous embodiments of the method result from the above description of the configuration of the control unit in a peritoneal dialysis machine according to the invention.

[0024] Further details and advantages of the invention can be gleaned from the following embodiments, which are described with reference to the drawings. [Brief explanation of the drawings]

[0025] [Figure 1] FIG. 1 shows a possible time course of the emptying rate (volume / time) in the abdominal cavity during the emptying phase with gravitational, i.e. passive, emptying. DETAILED DESCRIPTION OF THE INVENTION

[0026] According to embodiments, a peritoneal dialysis machine is provided for performing automated peritoneal dialysis therapy having a circulation cycle including an inflow phase, a dwell period, and a drain phase for dialysate. The machine includes a control unit and a measurement device for determining the inflow and / or drainage rates of dialysate to or from a patient. The machine further includes a dialysate pump for delivering dialysate to the patient, and a drain valve opened by the control unit after the dwell phase and before the start of the drain phase to allow gravity drainage of dialysate from the patient.

[0027] The reference curve for the time course of the elimination phase is patient-specific and is stored in a memory, e.g., a control unit, formed by superimposing curves measured during the elimination treatment in a certain number of previous cycles. An algorithm is further stored in the control unit, which is associated with the comparison between the time course curve of the elimination rate determined by the measuring device during the further elimination phase and the reference curve. The algorithm further enables the recognition of a disturbance in the elimination of dialysate from the patient based on this comparison.

[0028] Instead of memory being physically located on the machine, the memory may also be located on a movable item such as a patient card or any other data store that does not form part of the machine.

[0029] If a fault is recognized, the control unit is configured to take a series of measures.

[0030] A specific observation phase, for example a 3-minute observation phase, is first initiated in which the discharge rate is continuously measured and checked for re-attainment of a minimum flow rate, which corresponds to the flow rate that should exist before the occurrence of a fault minus a tolerance of, for example, 30%.

[0031] If the minimum flow rate is not reached again during the observation phase, the control unit starts the dialysate pump to deliver a specified smaller volume, for example 100 ml, in the direction of the patient. The quality of the line can be checked using this measure.

[0032] The above values are non-limiting examples of the invention.

[0033] Alternatively or additionally, a warning signal, preferably an acoustic signal, can be output.

[0034] If a fault occurs as part of this filling test, which could indicate, for example, a kink in the catheter, the control unit outputs an acoustic signal to a signal unit mounted on the machine, which should be suitable to wake the patient and alert him or her to reposition himself or herself.

[0035] After this step, reassessment takes place in the form of repeated observation phases and repeated filling tests. The signaling can also be repeated in the same or more intensive form so that the patient actually sits up if necessary to check the function of the line.

[0036] The "baseline" curve in the figure shows the drainage rate over time for a machine according to an embodiment in a normal case, where the drainage rate decreases as the patient empties due to a decrease in hydrostatic pressure. This duration can be, for example, a total of 5 minutes.

[0037] The curve "Obstacle 1" in the figure shows the drainage rate over time if drainage is impeded just before the end of the drainage phase, which can occur, for example, if the drainage catheter sags or becomes blocked or stuck / kinked so that further drainage can no longer continue below a certain hydrostatic pressure.

[0038] The curve "Obstruction 2" in the figure finally shows the time course of the drainage rate when the outflow has already been obstructed some time ago, as may occur, for example, when the drainage catheter is sagged or blocked, e.g., blocked, by the patient's movements while asleep, so that further drainage can no longer continue below a certain hydrostatic pressure.

[0039] Advantages of the solution according to the invention include, for example, avoiding premature switching from the drain phase to the inflow phase of the following cycle, as well as improving the overall drain behavior and thus optimizing the treatment. The number of drain phases ended in an incorrect or unnecessary way can be reduced. There is also less possibility for the user to negatively influence the machine behavior. The patient has improved feedback regarding, for example, his / her sleeping position, bed height or machine location.

Claims

1. 1. A peritoneal dialysis machine for the performance of peritoneal dialysis therapy having a circulation cycle including an inflow phase, a dwell period and a drain phase for dialysate, said machine having a control unit and a measuring device for determining the rate of inflow of said dialysate to a patient and / or the rate of drainage of said dialysate from a patient, the control unit is configured to perform a comparison between the time course curves of the inflow rate and / or the outflow rate determined by the measuring device during the inflow phase and / or the outflow phase and a corresponding reference curve, and to recognize a disturbance in the inflow of the dialysate to the patient and / or the outflow of the dialysate from the patient based on the comparison; the control unit is configured such that, upon recognition that the inlet rate and / or the outlet rate has fallen below a minimum flow rate corresponding to a flow rate from a reference curve minus a tolerance range, a timed observation phase is initiated during which the inlet rate and / or the outlet rate are measured, and the control unit checks whether the inlet rate and / or the outlet rate have reached the minimum flow rate again; the control unit is configured to output a signal regarding the recognition of an obstruction in the inflow and / or outflow of the dialysate to the patient if the inflow rate and / or the outflow rate do not reach the minimum flow rate again, After the timed observation phase has elapsed, the signal is output; A peritoneal dialysis machine, characterized in that the reference curve is a patient-specific function and is formed by superposition of curves measured in a specific number of previous cycles or treatments.

2. 2. The peritoneal dialysis machine of claim 1, wherein the control unit is configured such that, upon recognition of an obstruction in the drainage of the dialysate from the patient, a predetermined amount of dialysate is conveyed in the direction of the patient.

3. 3. The peritoneal dialysis machine of claim 1, wherein the signal is a visual signal, an acoustic signal, or a vibration signal.

4. A peritoneal dialysis machine according to any one of claims 1 to 3, characterized in that the control unit is configured to optimise the operation of the machine based on the comparison.

5. A peritoneal dialysis machine according to any one of claims 1 to 4, characterized in that the machine is a gravity operated machine.

6. 5. The peritoneal dialysis machine according to claim 1, wherein the machine is a machine that actively delivers dialysis fluid.

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