JP2921857B2 - Continuous circulation peritoneal dialysis apparatus and method - Google Patents

Description

Description: BACKGROUND OF THE INVENTION The present invention relates to a dialysis process for purifying blood by a continuous flow of dialysate and transfusion through the peritoneum.

In summary of the present invention, a continuous circulation peritoneal dialysis system and process is disclosed that includes a source of sterile dialysate, and an inflow line and an outflow line coupled to a catheter implanted in the peritoneal cavity of a patient. . The infusion pump pumps sterile dialysate through the inflow line from the source to the catheter during the infusion cycle. The drain pump pumps fluid from the catheter through the drain line to the drain during the drain cycle. The function of dialysate volume in the peritoneal cavity is detected by a manometer. The process controller controls the infusion and evacuation pumps in response to signals from the high and low fluid level detectors in the fluid column tube so that fluid generally flows through the cavity at zero dwell time. Pumping the calibrated injection volume of fluid into the cavity and the calibrated ejection volume of fluid from the cavity continuously in alternating infusion and evacuation cycles. In this process,
The inflow volume of dialysate pumped into the cavity is measured,
The outflow volume of the fluid pumped from the cavity is then weighed and the amount of fluid removed from the patient is determined by comparing the inflow and outflow volumes. A glucose pump is coupled to the glucose source and the inflow line and delivers a regulated amount of glucose in response to a comparison of the metered inflow and outflow volumes.

Until now, artificial kidney users have been trying to purify blood,
Basically, we focused on two processes. Hemodialysis
It involves the circulation of blood by a dialyzer, where the exchange of toxic metabolites takes place through an artificial membrane outside the patient's body. This process requires the assistance of trained personnel and places the patient at risk of mechanical dysfunction due to the fact that blood vessels are involved.

Peritoneal dialysis involves the injection of sterile dialysate into the peritoneal cavity, and after absorbing waste metabolites, the dialysate is discarded.
The process is then repeated until the level of metabolite is reduced to the desired level. This method is due to the fact that multiple one or two liter bottles or bags of fresh dialysate solution are used and require multiple connections between the catheter inserted into the peritoneal cavity during the dialysis process. To
Generally referred to as a "batch" method. The binding of multiple bottles and lumps during the course of dialysis was thought to be a major cause of high cases of peritonitis.

Continuous ambulatory peritoneal dialysis provides continuous peritoneal dialysis while allowing the patient some open time. However, continuous ambulatory peritoneal dialysis must be performed in the absence of a machine, and many dialysis bottles or bags must be infused daily. Thus, multiple daily infusions require multiple bags or bottles to be connected to the peritoneal catheter. The production of large volumes of sterile dialysis for peritoneal processes has been impractical, especially for large-scale applications for home dialysis.

U.S. Pat. No. 4,311,587 circumvents some of the above problems associated with peritoneal dialysis by providing a sub-micron filter coupled with fresh dialysate to prevent peritoneal contamination. Ask for. The system is patrol and a bag of dialysate is worn on the patient. The bag is pressurized in a number of ways and is connected only to the inlet side of the filter. The outlet port of the filter is connected on the other side of the filter, so that no peritoneal sources are connected directly to the peritoneal cavity. The system is essentially a batch-type system, and multiple dialysate bottles or bags must be coupled to the filter, even though direct coupling to the peritoneal catheter is not required.

U.S. Pat. No. 4,338,190 discloses a system and process that attempts to circumvent the batch processing method previously used in peritoneal dialysis, where closed loop peritoneal circulation is provided and toxic metabolites are exchanged. A selective membrane. The solution is passed to the other side of the selection membrane to maintain the original sugar and salt concentrations in the peritoneal fluid as the toxic metabolites pass through the separation membrane. The sugar and salt concentrates are mixed in the desired ratio, with water constituting the dialysate. The conductivity of the fluid is
It is monitored automatically to adjust the concentration of the recirculating fluid. Dual peritoneal catheters provide inflow and outflow of peritoneal fluid. However, peritoneal fluid is constantly recirculated through the peritoneal cavity and, due to residual toxins returned to the peritoneal cavity,
The effectiveness is slightly reduced. Selective membranes are expensive disposable items, meaning that the cost of operating the system will be high if the membrane is not rewashed. Pumping of peritoneal fluid through the peritoneal cavity is required, making it difficult for the patient to ensure that proper distension is maintained during the dialysis process. If the peritoneum is not fully distended, the peritoneal fluid penetrates very intricately around the intestine, forming pocket-like things that hide the peritoneal fluid. Incomplete circulation then results in reduced dialysis effectiveness. Control is not performed at the level of peritoneal fluid in the peritoneal circulation. In the peritoneal circulation, there is no method for replenishing peritoneal fluid even when the peritoneal fluid is insufficient and falls dry.

No. 3,545,438 discloses a batch peritoneal dialysis method, which provides for the partial reuse of a portion of the dialysate. The used fluid is mixed with the new fluid. To allow the dialysate to flow continuously into the peritoneal cavity without dwell time,
There is no control or monitoring of fluid flow. German Patent 2, 14
U.S. Pat. No. 3,707,967, corresponding to 9,040, clearly discloses a closed loop dialysis system, wherein peritoneal fluid is continuously circulated through the peritoneum. The combination of flow control and monitoring in the inflow and outflow lines with a continuous circulation open circuit does not exist in the German application. Patent No. 3,
No. 709,222 generally discloses a batch-type peritoneal dialysis method. In the '222 patent, the amount of dialysate flowing into the peritoneal cavity and the pressure in the peritoneal cavity are controlled by changing the height of the pressure relief chamber. This is inaccurate and unreliable, and requires that an attendant be present to perform the process. The cycle associated with the process is fairly complex and involves an initial priming cycle that includes filling the compounding chamber and pressure relief and return chambers. To begin the process, dialysate is allowed to flow from the pressure relief chamber into the peritoneal cavity until the chamber is moved to a lower position that prevents fluid flow. Next, an automatic cycle is started, in which fluid is pumped from the cavity into the return chamber. Next, the inflow cycle is started, in which the fluid is:
The pump is pumped from the return chamber into the compounding chamber and pushes fresh dialysate from the compounding chamber into the pressure relief chamber and flows into the patient. Next, there is an equilibrium cycle, where the dialysate is drained from the compounding chamber and fresh dialysate is added. Obviously, during this time dialysate is left in the cavity. The process is then switched back to the bleed cycle, where the fluid is pumped from the cavity to the return chamber. French Patent No. 2,371,931 discloses a peritoneal process with a single conduit used for inflow and outflow. The method involves pumping in a volume of dialysate, diffusing it for a defined dwell time, and removing dialysate. This is, in essence, an automatic "batch" system. In the related co-pending application referenced above, a peritoneal dialysis process is disclosed that involves the continuous inflow and outflow of fluid using a dual catheter in open loop circulation, where the fluid comprises:
Discarded rather than recycled. Other aspects of these processes include the use of a single catheter open circulation system, with zero dwell time for fluid in the cavity, with alternating inflow and outflow cycles. The present invention relates to improvements in the control of these processes and to the control of fluid permeability in response to the amount of fluid removed from a patient. Permeability is based on patient fluid weight loss (basi
s) is adjusted accordingly and continuously.

Accordingly, it is an important object of the present invention to provide a continuous circulation peritoneal dialysis system and method that avoids the inherent problems and risks of batch type peritoneal dialysis systems.

Yet another important object of the present invention is to provide a peritoneal dialysis system with a high rate of dialysate exchange that provides increased dialysis efficiency.

Yet another important object of the present invention is to provide a peritoneal dialysis system and method having a high rate of dialysate exchange and dialysis efficiency, wherein the permeability of the fluid is determined by the amount of fluid removed from the patient. Is continuously adjusted in response to

It is yet another object of the present invention to provide a continuous flow single pass peritoneal dialysis system and method wherein the pressure and volume of dialysate in the patient's peritoneum is simple and convenient without the need of the attending physician. Monitored and set by the patient in any suitable manner.

SUMMARY OF THE INVENTION The above objects are achieved by the present invention by the following peritoneal dialysis system and process, wherein a continuous flow of sterile dialysate is generated and passed through a single channel of open circulation to the patient's peritoneum. Flows through the cavity. The exchange of toxic metabolites takes place through the patient's peritoneum and the residual dialysis solution is drained out of the patient's cavity. A positive displacement pump and pump pumps fluid during the pump and pump cycles,
And weigh. A manometer is coupled to the flow path to monitor peritoneal pressure as a function of volume. A high level detector detects high fluid levels in the manometer tube and disconnects the infusion pump and cycle, while the zero dwell dialysate immediately initiates the evacuation pump and cycle. A low level detector detects a low fluid level in the manometer tube and immediately reverses the drain cycle to the injection cycle. The number of revolutions of the pump is counted during the infusion and evacuation cycles to determine the amount of fluid flowing into and out of the cavity. The weight and volume of fluid removed or taken up by the patient is calculated. The permeability of the glucose concentrate and solution is then altered to provide the desired permeability and patient weight loss or addition.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Configurations designed to implement the present invention are described below, together with other features.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be more readily understood by reading the following description, in which embodiments of the invention are shown with reference to the accompanying drawings, which form a part hereof.

Referring in detail to the drawings, a continuous inflow / outflow peritoneal dialysis process and system is shown in FIG. 1 and includes a water purification and dispensing unit 10 coupled to a water source 12. Unit 10
Is a suitable unit for sterilizing and dispensing water, such as a conventional reverse osmosis unit. Unit 10 communicates as shown by way of a prepare and start line 10a, 10b leading to a process controller generally designated as A. Unit 10 has no information from the process controller other than ready or not ready. The dialysate blending unit 14 receives the concentrate dialysate from the source 16 and mixes with sterile water from the unit 10 to provide a defined proportion of dialysate and water concentrate. Unit 14 is a conventional compounding pump having a structure that produces a specific ratio of fluid. One fluid drives the pump and the other is pumped by the pump. Fluid flows out at a certain fixed ratio. Unit 14 also includes pressure regulation, temperature sensing, conductivity sensing,
Includes bypass and exhaust valve mechanisms. This is because the system
Allows to function in three modes of operation. The first mode is a sterilization mode, which is a static mode of the machine. It is filled with a sterile solution, maybe Clorox. The second mode of operation for the machine is rinsing and preparing for the dialysis mode. The unit is operated in the second mode until conditions are stable and appropriate for dialysis of the patient. The third mode is an operating mode, in which the actual dialysis process is performed.
Unit 14 is controlled by dialysis process controller A and is responsive to detection in unit 14 that provides data to the process controller. Process controller A is a suitable process controller of conventional design that is well within the capabilities of a person having average skill in automatic control technology.

The system is started by actuation of the start button 18. Once the process controller has passed sterilization and has entered a run cycle, the dialysis process controller is started. Operation light 20 in controller A
Informs the patient that the machine is ready for operation and includes additional audible, visual, or both signals to the patient. The patient then couples the tubing set 22 from the dialysis treatment unit to a single flow catheter 26 that is placed in the patient's peritoneal cavity 28 in a conventional manner. Once the patient has joined his tubing set, he presses the infusion button 30 on the dialysis process controller, completes all necessary preparations, and acknowledges that he is ready to begin the dialysis procedure I do. At this point, the time clock 32 in controller A begins to accumulate the time that the cycle is in progress. The time clock is terminated by the alarm, patient, or maximum cycle number parameter set. The elapsed time accumulated throughout the entire cycle is displayed at 32a. Elapsed time 32 as long as the machine is running
Are accumulated. The process is started and the patient receives dialysate from infusion pump B. Pump B is preferably a peristaltic roller type pump, and the dialysis blending unit
Pump fluid from 14 through line 34 into tube 22 and cavity 28. Pump B is controlled by processor A.
To this end, pump B sends electrical leads to controller A to send speed and displacement signals, respectively.
Combined by 36a, 36b. The patient continues to receive fluid until the comfort level is reached. The patient manually sets the comfort level by depressing the infusion set button 38 when the initial infusion reaches a point at which the comfort level is deemed to be a comfortable level and the cavity feels slightly bloated. Pressing button 38 is the injection level or volume to be set.
It then instructs process controller A to repeat the process cycle for a particular volume of fluid.
The process controller immediately reverses the cycle from injection to drain for the fluid in cavity 28 without dwell time. The volume of fluid pumped into the patient is countered whenever the machine is infusing in the infusion volume.
40, weighed, accumulated, and controller A
Is displayed by the display 40a. Infusion volume 40a is a cumulative total, as it pertains to one dialysis process for one patient. This is the elapsed time 32a
Corresponding to

The infusion cycle stops and the drain cycle begins immediately at the point where the patient presses the infusion set button 38. When the patient presses the infusion set button 38, he also sets the slidable high pressure detector 50 on the manometer means D to correspond to the infusion volume. A fluid column tube 48 is coupled to the joint 42 for containing a fluid and is vertically oriented in an upright manner. Millipore filter 54 exhausts tube 48 to the atmosphere. Column tube 48 includes a high fluid and pressure detector 50 and a low level and pressure detector 52 to provide manometer means D. The detectors 50, 52 are standard photocell detectors or infrared sensors for detecting the presence or absence of fluid at high or low levels. For this purpose, the detector
Attached to the slide brackets 50a, 52a so that the high / low point is set to a specific point. The patient calibrates the high pressure point by sliding the detector to the level of fluid seen when the infusion set button is pressed. Alternatively, tube 48 is slidably mounted. The high and low pressure levels tend to be constant for a given patient. Tube 48 is preferably a plastic tube, and preferably need not hang vertically. This provides a very simple, but sensitive and accurate means of detecting pressure in the cavity and thus the peritoneal volume. Fifteen
Very little pressure in centimeter water is detected. The patient presses the infusion set button and the high pressure detector
After calibrating 50, the operation is automatic. After the infusion cycle, the controller A turns on the discharge pump C, preferably in the form of a peristaltic pump, without dwell time. The pump begins to drain fluid from cavity 28. Discharge pump C is connected to tube 22 via joint 42. Pump C is controlled by controller A and has leads 44a, 44b coupled to the pump. Lead 44a sends the speed signal to pump C, and lead 44b connects the sensing capacitance (r
pm) signal to controller A. The drain cycle is a function of infusion pump stop and drain pump start. Infusion pump B and discharge pump C are positive displacement pumps and have the ability to pump and meter fluid. Cumulative infusion volume is a function of pumping pump inflow and evacuation is a function of pumping pumping in rpm. Pump C has a pressure in the peritoneal cavity 28
The fluid in the column tube 48 attached to 42 is drained until it no longer supports the column 46. The fluid height in the column tube 48 drops to a specified low pressure point detected by the low level detection device 52. The low pressure point 52 is preset in controller A corresponding to the minimum pressure or calibrated by sliding the detector in the tube. At this point, the patient's cavity is evacuated to the point where the dialysis process reaches the diminishing returns of the effusion cycle. This keeps the cycle time to a minimum. The cycle then reverses, and once again becomes an injection cycle. At this point, the discharge capacity is
The volume weighed by and collected from the patient is shown on the controller display 60a as it continues to accumulate. Because this is cycle one, it is the exact amount of the initial discharge. The cycle operation display 62a of the cycle counter 62 is incremented to 1 and the first
Indicates that a cycle has been completed and another cycle has begun. The cycle continues until the height of the fluid in the column approaches the high pressure sensor, and the fluid does not reach it and rests above and below. Pump C
Pumping is an intermittent, not continuous, pumping action. Pump speed governs column height.
When the cavity 28 reaches the infusion level, the fluid in the tube 48 vibrates rapidly above and below the high pressure detector 50, and the controller A slows down the pump B. The pump speed is reduced to the end of the inflow cycle, and the delivery of fluid to the patient is slower. When the fluid level is generally constant at occlusion detector 50, pump B is shut off. Then the cycle is reversed once more, and a drain cycle is initiated by controller A. The same variable speed operation of pump C occurs during the evacuation cycle. The reversal cycle continues until the patient terminates it, the maximum time has elapsed, the infusion volume has timed out, or an alarm in the system has stopped it. At exactly the time the patient depresses the stop button, the pump injects dialysate and has a column high pressure level in all cases. The pump is pumped and low pressure is maintained at low pressure sensor 52 in all cases. It is the pump speed corresponding to the maintained column height that determines when the cycle trips.

The setting of the injection volume is now described in more detail. When the infusion set button 38 is depressed, the pump reaches a certain recording speed. It causes the column tube 48 to fill.
The column height is reached, and the pump is, for example, about 10 rp
m. The pump starts running at a maximum rpm, which is about 40 rpm. Pump, column, high pressure sensor 50
Continue at the maximum rate until you reach. As soon as the liquid reaches this level, it exceeds it. The liquid reaches this point by acceleration and until the pump speed is reduced
Continue beyond that point. When the patient contains the fluid and actually creates more resistance to the fluid, it slows down into the patient's body. The pump must slow down to maintain column height. At the point where the patient becomes uncomfortable, he presses the infusion set button, and the machine immediately reverses. There is a pump speed corresponding to the injection pressure. The patient presses the infusion set button as often as desired throughout the entire process. For example, at the outset, the patient is probably not relaxed, the tissue in the abdomen is not stretchable, and perhaps a small area (area) can be stored. After the body has become accustomed to the process, the patient can accommodate more. For this reason, the patient
Press the infusion button, and the system starts infusion,
The infusion is given until the patient presses the infusion set button.
This gives the patient different infusion volume levels. Pressing the infusion set button creates a memory of the exact state of the unit at the time the button is pressed. Pressing the set button transmits an infusion command (command) to the controller, which causes the infusion set button to be pressed again or until the system reaches the internally programmed maximum value. Filling continues. These values include physiological safety values. These values are not always comfortable for the patient, but do not harm the body. In an emergency, the patient depresses the eject button 66 and releases the connector hose and releases himself. The value at which the machine automatically enters the drain mode probably exceeds some comfort level, but does not exceed the safety level. This is preset by the controller. It is not accessed by the patient.

Means are provided for adjusting the permeability of the dialysis solution delivered to the patient in response to the amount of fluid removed from the patient. The adjusting means continuously adjusts the permeability of the solution so that a desired amount of fluid is removed or, in some cases,
Guarantee that it will be added. The adjusting means is an infusion pump B
A glucose pump E, preferably of the peristaltic type, coupled to an inflow line upstream of the pump, and the inlet of the pump E is coupled to a glucose source 70. Pump E is controlled by controller A in response to the amount of fluid removed from the patient, to achieve the desired patient weight loss.
Adjust the glucose concentrate and osmosis of the dialysate flowing in from 16. It is noted that infusion pump B and evacuation pump C are fixed displacement roller pumps and are used to accurately meter the amount of infusion and evacuation fluid. By measuring the number of revolutions per minute of the pump and the pumping time,
The volumes of the infusion and outflow fluids are accurately metered and determined. The same applies to glucose pumping E in terms of the amount of glucose pumped and mixed with the dialysate to accurately determine the glucose concentrate and permeability of the solution. For a given patient, the patient's dry weight is easily estimated. By calibrating the patient prior to dialysis, the amount of weight loss desired during dialysis is determined. This determines the amount of fluid removed from the patient during dialysis. Based on the length of time the process runs,
The amount and ratio of glucose needed for the desired weight loss is determined. Controller A calculates the volume of infusion and outflow fluids from the volumetric rpm signals on leads 36b and 44b from each pump. By comparing these signals, it is determined how much fluid is removed from the patient. If the weight, i.e., fluid, is not properly removed, a drive signal is sent from controller A via lead 72 to glucose pump E to accelerate the pump and increase the glucose supplied to the dialysate. And increase fluid removal. If the weight is removed too much, the glucose pump is slowed down to reduce the amount and ratio of glucose mixed with the fluid.
Adjustment of the glucose concentrate and osmosis automatically causes a standard dialysate solution to be supplied at 16. The concentrate is pump E
The patient can be easily tailored by changing the amount of glucose. Providing different pre-prepared dialysates for different patients is not necessary because the concentrate is easily changed by the process and system of the present invention in an automated and convenient manner. Glucose is changed automatically during the dialysis process to achieve the desired weight loss or, where appropriate, addition.

Referring to FIG. 2 in more detail, a block diagram of one suitable controller is shown. There is a manually driven start / stop circuit 80, with push buttons allowing the start, stop and continue of the process to be accumulated when the patient has to adjust position, comfort or temporary interruption. No lost control parameters or data will be lost. The operation indicator 80a lights up when the process proceeds. Mode circuit 82 determines the inject / eject cycle of operation. The fill and drain manual push buttons 30, 66 are activated at any time to interrupt automatic control and change to the opposite mode. The injection comparator 84 is driven by the motor of the pump B.
86 and monitor the infusion mode, limit the infusion rate of Pump B to the set value at the maximum infusion rate, and activate Reverse the circuit. A discharge comparator 88 is coupled to the motor drive 90 of the discharge motor C, monitors the discharge mode to limit the discharge speed of the pump C to a set value at the maximum discharge rate, and the peritoneal pressure during the discharge cycle is When the predetermined minimum value in the preset pressure control is reached, the mode circuit is reversed. Infusion set button 38 is used by the patient during the first infusion half cycle of the procedure to establish the maximum infusion volume and store it in memory. Patient comfort is the criterion for this setting. Inject / eject indicators 30a, 66a indicate which mode the system is in at that moment. Injection / ejection motor drives 86, 90 provide power to each motor to provide the desired pumping action. High / low pressure sensors 50, 52 monitor the height of the dialysate column in a tube positioned to represent peritoneal pressure. High sensor 50 detects high pressure levels and low sensor 52
Detects low pressure levels. This data is used to control the inject / eject rate. The inject / eject motor drives the peritoneal roller mechanism relative to the sterile tube set to pump dialysate. An infusion motor pumps the dialysate into the patient's peritoneal cavity. The drain motor pumps dialysate from the patient's peritoneal cavity.

The cycle monitor circuit 92 measures the injection and discharge volumes of each cycle and compares them with predetermined values of the minimum and maximum volumes every half cycle, as set by the minimum and maximum volume controls. If the capacity is not at the allowed value, a violation signal is registered. Abnormal cycle counter 94
Counts violations, and if a predetermined number occurs in one row, as set in the abnormal cycle count limit, the process is stopped, draining is activated, and the alarm cycle 96 is activated. The alarm circulation 96 may be an abnormal cycle counter or a dialysate blending unit 14
Or until a violation signal is received from any of the water sterilization units 10 and the reset button 98a is pressed.
Trigger audible and visible alarms. Weight loss counter 10 measures the infusion and evacuated volumes and calculates the instantaneous weight loss volume by pulses from infusion and evacuation pump sensors 36b, 46b. The weight loss comparator 102
The weight loss value and the elapsed time from the elapsed time clock 32 are used, and the weight loss is calculated and compared to a predetermined value as set in the control of the weight loss set and the treatment duration set. If the rate needs to be changed to achieve the goal, a high or low signal is sent to the adjustable delay timer 104. If the procedure has proceeded for a delay time value, as set in the delay set control, the up / down signal will cause the glucose ratio memory circuit to change the ratio from a predetermined value set in the initial glucose rate. Sent to 106. This overall evaluation and adjustment process is continuously repeated to achieve the weight loss goal. Glucose rate control 108 receives this ratio signal and converts it to a pulse rate,
For very accurate glucose mixing into the dialysate,
The stepper type glucose motor E is driven through the glucose motor drive 110.

The infusion and dispense volume counters 40 and 60 measure and display their accumulated volume in liters, respectively, by counting the pulses from the infusion and dispense sensors 36b, 44b triggered by each revolution of the peristaltic pump. The elapsed time clock 32 measures and displays the total time in which the procedure has progressed in hours and minutes. The cycle counter 62 measures and displays the total number of fill and drain cycles. Reset circuit 98 resets all counters and clocks to zero when the reset pushbutton is pressed for four seconds. Power supply 112 supplies current to all components from a standard 117 VAC normal power supply.

Although preferred embodiments of the invention have been described using specific terms, such description is for illustrative purposes only, and changes and modifications may be made without departing from the spirit or scope of the claims. It is understood that what is done.

 The main features and aspects of the present invention are as follows.

1. Providing a sterile source of dialysate; providing an inflow line coupled to a catheter adapted for implantation into a patient's peritoneal cavity; and an outflow line coupled to the catheter Pumping sterile dialysate from the source to the catheter through the inflow line during the infusion cycle and draining the catheter through the outflow line during the drainage cycle. Using a pump means for pumping the fluid into the peritoneal cavity, monitoring the function of the volume of the sterile dialysate in the peritoneal cavity, and in a manner such that the fluid generally flows through the cavity at zero dwell time. Controlling said pump means to pump a calibrated infusion volume of fluid into and out of said cavity in a continuous infusion and evacuation cycle; and Pong Continuously circulating peritoneal dialysis, wherein the effluent volume of the pinged fluid is delivered to a disposal means so that a single pass of the dialysate occurs through the peritoneal cavity of the patient during the infusion and evacuation cycle. Method.

2. the pump means is provided by an infusion pump in the inflow line and a discharge pump in the outflow line for pumping the infusion and outflow volumes of the dialysate from the peritoneal cavity; To stop the infusion pump and start the drainage pump in response to the detection of and to stop the drainage pump and start the infusion pump in response to the detection of a defined low pressure; The method of claim 1, comprising detecting pressure in the inlet line to monitor the completion of a volume. Detecting the pressure by using manometer means coupled in the inlet line capable of detecting a slight water pressure of 3.15 centimeters or more and several centimeters, and each of the fluids in the manometer means Detecting the high and low pressures by detecting the high and low pressure levels.

4. The method of claim 2, comprising generating an alarm signal in response to a prescribed pressure corresponding to a fluid volume above a prescribed level to avoid overfilling the cavity.

5. Mixing the dialysate and glucose prior to pumping the fluid into the cavity; determining the amount of fluid removed from the patient's predetermined cavity; and removing the fluid from the patient. Adjusting the amount of glucose mixed to change the glucose concentrate of the infusion volume fluid in response to the amount of fluid.

6. Measure the inflow volume of dialysate pumped into the cavity and the outflow volume of fluid pumped out of the cavity, and determine the amount of fluid removed from the patient by comparing the inflow and outflow volumes 6. The method according to the above 5, which comprises:

7. Providing a glucose pump coupled to the glucose source and the inflow line, and responsive to the comparison of the inflow and outflow volumes to adjust the glucose content and osmosis of the infusion volume fluid. 7. The method of claim 6, comprising controlling the pump.

8. The method of claim 1, comprising controlling the flow rate of dialysate in the inflow and outflow lines, such that dialysate flows into and out of the peritoneal cavity in a continuous circulation manner.

9. detecting the fluid level of dialysate in the fluid column tube at a high point to terminate the infusion cycle and detecting the fluid level at a low point to terminate the drain cycle. The method of claim 1 comprising:

10. The method of claim 9, comprising manually calibrating and setting at least the high point of the fluid level detection in response to the patient reaching the desired infusion volume level and distension.

11. The method of claim 1, comprising closing the outflow line when dialysate flows into the peritoneal cavity, and closing the inflow line while the fluid flows out of the cavity. .

12. A source of sterile dialysate, an inflow line adapted to be coupled to the source, a peritoneal catheter implanted in the peritoneal cavity of the patient, and an outflow adapted to be coupled to the peritoneal catheter. Controlling the flow rate of the dialysate in the inflow and outflow lines;
Pump means for controlling the infusion volume of the dialysate pumped into the peritoneal cavity during the infusion cycle and the evacuation volume pumped from the cavity during the evacuation cycle; and a function of the volume of dialysate in the peritoneal cavity. Controlling the pump means in response to the detector means to start and stop the respective infusion and evacuation cycles, generally simultaneously with zero fluid dwell time of fluid in the cavity. Control means for releasing the effluent volume of dialysate and disposing means coupled to the outlet line for establishing a single pass open circuit through the peritoneal cavity for dialysis. Continuous circulation peritoneal dialysis machine.

13. The method of claim 12, wherein the pump means includes an infusion pump in the inflow line for pumping fluid into the cavity, and a discharge pump in the outflow line for pumping the fluid from the cavity. apparatus.

14. The method of claim 12, including adjusting means for adjusting the glucose content of the dialysis to change the permeability of the dialysate in response to the amount of fluid removed from the patient during the dialysis process. Equipment.

15. the adjusting means for measuring the inflow volume of the fluid pumped into the cavity, and measuring means for measuring the outflow volume of the fluid pumped from the cavity; and for adjusting the glucose content, The glucose release means controlled in response to the metering means.
An apparatus according to claim 1.

16. The detector means comprises: a fluid column tube coupled to the inflow and outflow lines; a high detector for detecting a high level of fluid in the column tube; and a low level of fluid in the column or the like. And a high detector to detect the infusion cycle, wherein the injection cycle begins in response to the low detector, and the ejection cycle comprises:
13. The apparatus of claim 12, wherein said apparatus starts in response to said high detector.

17. The apparatus according to claim 16, wherein at least the high detector and the column tube are relatively slidably arranged so that the high detector is manually set and calibrated.

18. A glucose pump having an inlet coupled to the glucose source and an outlet coupled to the inflow line, and measuring the inflow volume of the fluid pumped into the cavity, and the fluid pumped from the cavity. Metering means for measuring the effluent volume of the fluid; and changing the amount of glucose delivered to the influent line in response to the influent and effluent volumes to alter fluid permeability. Means for regulating the glucose pump.

19. The pump means includes an infusion pump in the inflow line for pumping fluid into the cavity, and a discharge pump in the outflow line for pumping the fluid from the cavity; 19. The apparatus according to claim 18, including a counter for counting the number of revolutions per minute of the infusion and evacuation pumps to measure the inflow and outflow volumes, respectively.

20. providing a dialysate; initiating an infusion cycle by flowing the fluid into a patient's peritoneal cavity; detecting a function of the peritoneal volume of the fluid in the cavity; Terminating the infusion cycle in response to detecting; initiating an evacuation cycle in response to the infusion volume by draining the fluid out of the cavity; and detecting the evacuation volume. Terminating the discharge cycle in response to the following, repeating the injection and discharge cycle, generally at zero dwell time, between alternating fill and discharge cycles until the process is completed; Adjusting the amount of glucose mixed with the infused volume of dialysate in response to the comparison of the volumes of peritoneal dialysis.

21. Measuring the inflow of fluid to measure inflow volume, measuring the outflow of fluid to measure outflow volume, and ensuring removal of the proper amount of fluid from the patient Adjusting the amount of glucose mixed with the dialysate to change the permeability of the solution in response to a comparison of the metered inflow and outflow volumes continuously during the dialysis process. 21. The method according to the above 20, comprising:

22. providing a dialysate; pumping an influx of the fluid into the patient's peritoneal cavity during an infusion cycle; detecting a peritoneal pressure of the fluid in the cavity; and responsive to the high peritoneal pressure. Terminating the infusion cycle; pumping the fluid flow from the cavity in response to the high pressure during the evacuation cycle; terminating the evacuation cycle in response to the low peritoneal pressure. A continuous peritoneal dialysis method comprising repeating said infusion and evacuation cycle between alternating infusion and evacuation cycles, generally at zero dwell time, until the process is completed.

23.Pumping the inflow of fluid by an infusion pump coupled to the dialysate and the peritoneal cavity; pumping the outflow of fluid by a discharge pump coupled to the cavity and a drainage source; Detecting the peritoneal pressure by detecting high and low levels of fluid in a column tube coupled to the inflow and outflow lines, wherein the high level corresponds to the high peritoneal pressure. 23. The method of claim 22, wherein said low level corresponds to said low peritoneal pressure.

[Brief description of the drawings]

FIG. 1 is a schematic diagram illustrating a continuous flow peritoneal dialysis system and method according to the present invention, and FIG. 2 is a schematic diagram illustrating a process controller for the continuous circulation peritoneal dialysis system and method according to the present invention.

────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Henry H. Morton 28170 North Carolina, U.S.A. .Cl. ⁶ , DB name) A61M 1/28 A61M 1/14 511

Claims (7)

(57) [Claims] An inflow conduit adapted to be coupled to a generally continuous source of sterile dialysate, a source, a peritoneal catheter implanted in a peritoneal cavity of a patient, and a peritoneal catheter. An outlet line adapted to be coupled; and controlling the flow rate of dialysate in the inflow and outlet lines, whereby the infusion volume of dialysate pumped into the peritoneal cavity during an infusion cycle, and during the evacuation cycle. A pump means for controlling the displacement volume pumped from the cavity so that a defined amount of dialysate remains in the peritoneal cavity during the infusion and drainage cycles; Detecting means for detecting a function of the volume; control means for controlling the pump means in response to the detector means for starting and stopping the respective infusion and evacuation cycles; and Release capacity And a disposal means coupled to the outlet line to establish a single flow path of open circulation through the peritoneal cavity for dialysis, and to the amount of fluid removed from the patient during the dialysis process. A continuous circulating peritoneal dialysis device comprising: adjusting means for adjusting the glucose content of the dialysis to change the permeability of the dialysate in response. 2. The system of claim 1 wherein said pump means includes an infusion pump in said inflow line for pumping fluid into said cavity and a discharge pump in said outflow line for pumping said fluid out of said cavity. An apparatus according to claim 1. 3. An adjusting means for measuring the inflow volume of the fluid pumped into the cavity and measuring the outflow volume of the fluid pumped from the cavity, and adjusting the glucose content. And a glucose releasing means controlled in response to said metering means.
An apparatus according to claim 1. 4. A fluid column tube having a fluid level indicating pressure coupled to said inflow and outflow lines, a high detector for detecting a high level of fluid in said column tube. And a low detector for detecting a low level of fluid in the column tube, wherein the injection cycle begins in response to the low detector;
2. The apparatus of claim 1, wherein said ejection cycle begins in response to said high detector. 5. The apparatus according to claim 4, wherein at least the high detector and the column tube are arranged so as to be relatively slidable, so that the high detector is manually set and calibrated. 6. A glucose pump having an inlet coupled to a glucose source and an outlet coupled to the inflow line, measuring the inflow volume of the fluid pumped into the cavity and pumping from the cavity. Metering means for measuring the effluent volume of the infused fluid; and for varying the amount of glucose delivered to the inflow conduit in response to the inflow and outflow volumes to alter the permeability of the fluid. And means for regulating the glucose pump. 7. The pump means includes an infusion pump in the inflow line for pumping fluid into the cavity and a discharge pump in the outflow line for pumping fluid from the cavity. 7. Apparatus according to claim 6, wherein the metering means includes a counter for counting the number of revolutions per minute of the infusion and evacuation pump to measure the inflow and outflow volume, respectively.