KR20010022416A - Method and apparatus for performing peritoneal dialysis - Google Patents

Abstract

Provided is an automated peritoneal dialysis device capable of selecting and changing the composition of the dialysate delivered to the patient 10 to meet specific physiological needs during the course of treatment. The apparatus comprises means (P1) for measuring solutions of osmotic agent, electrolyte and other predetermined dialysate components which are conveyed from the separate solution vessels (S1, S2) into the mixing chamber means for mixing at a predetermined rate. . Means for delivering fresh dialysis fluid to the patient 10 and means for removing the spent dialysis fluid from the patient include means for monitoring pressure in the peritoneum and other conditions of the fluid in the peritoneum and dialysis fluid injection and removal. Electronic control means responsive to the signal of the monitoring means for adjusting the ratio.

Description

Methods and apparatus for performing peritoneal dialysis

Unlike the in vitro system used for hemodialysis (HD) to treat end stage renal disease (ESRD), PD uses the internal peritoneum to purify the blood of ESRD patients. Two modalities for performing PD are automated ambulatory peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD), a manual and non-automated procedure. According to the latter method, the dialysis fluid is exchanged four to six times daily for one day. The fluid remains in the patient's body for about 4 hours between exchanges and for longer periods of time (10-12 hours) at night.

It is common to refer to the basic steps of the PD procedure as Fill, Dwell, and Drain. At the fill stage, dialysate is slowly injected through the catheter into the peritoneal cavity of the patient.

For a fixed time, known as dwell, the dialysate draws soluble waste and excess fluid from the blood in the plurality of blood vessels of the peritoneum by osmotic and diffuse action. In addition, the dialysate is again balanced with electrolyte concentration and corrects for acidosis of blood.

When the dwell ends, the spent dialysate is removed (drained) from the peritoneal cavity. As the body continues to produce waste, this exchange action must be repeated several times over 24 hours.

Compared with HD, PD is a very mild mode, and the slow fertilization of PD is similar to that of natural kidneys. It is simple to operate, does not require venipuncture and lowers the cost of surgery. Because the system is not an in vitro system, there is no need for high levels of heparinization, a particularly important factor in diabetics.

However, to date, HD has continued to dominate the treatment of ESRD patients. The following view of the PD is the cause for this situation.

In PD, infection (peritonitis) is an important issue since the peritoneum is exposed to the external environment whenever the catheter is connected to or disconnected from the solution feeder.

Currently available commercially available dialysis fluids for PD show low pH which is substantially incompatible with the biochemistry of the peritoneum. Thus, such bio-incompatibility is considered one factor that eventually destroys the performance of the membrane over time.

The most popular osmotic agent used in PD dialysate is glucose, which can be absorbed into the body via the peritoneum. This can lead to obesity and the associated complications in the patient. Moreover, heat sterilization of the dialysate containing glucose produces harmful glucose byproducts.

PD's current technologies do not provide the ability to monitor pressure increases in the peritoneum during the dwell or fill phases.

Current PD solutions have a fixed composition, and during treatment, some or none of the components can be systematically controlled.

In an ongoing effort to provide adequate PD therapies for many different ESRD patients, clinicians have developed a number of different forms of APD treatment. These include the following APD schemes:

(i) Continuous Cycling Peritoneal Dialysis (CCPD), a method in which an automated cycler performs PD with four to six regular exchanges each night.

(ii) Intermittent Peritoneal Dialysis (IPD), a method of performing PD 2 to 3 times a week for about 8 to 20 hours each with an automated cycler in a hospital or home.

(iii) Nightly Peritoneal Dialysis (NPD), a method of performing nighttime peritoneal dialysis at home for patients with high-efficiency peritoneum. Such patients do not live comfortably with prolonged dialysate dwells.

(iv) Tidal Peritoneal Dialysis (TPD). This approach initially uses the maximum dialysate fill volume (typically 3 liters), drains a portion of the fill volume (usually 1/3, periodic variability volume), and periodically ultrafiltration during long, continuous dwell times. Control the excess fluid (excess fluid is removed from the patient's body during kidney dialysis) and pour approximately the same amount back into the patient's body.

Various examples of somewhat “automated” peritoneal dialysis devices are known in the art. US Patent No. 4,096,859 to Agarwal et al .; US Patent No. 5,141,492 to Dadson et al .; U.S. Patent 5,324,422 to Colleran et al .; And US Pat. No. 5,438,510 (Bryant et al.) And the like. They have proven unsatisfactory in many ways to address clinical issues or to effectively implement PD schemes as described above.

The present invention relates to novel apparatus and methods for performing automated peritoneal dialysis (PD).

1 is a schematic diagram of a first embodiment of a "basic" APD device according to the present invention.

FIG. 2 schematically illustrates one liquid inlet / outlet port and part of the occlusion mechanism in the apparatus of FIG. 1.

3 shows an exploded view of the occlusion mechanism for the automated peritoneal dialysis device according to the present invention.

4 is a graph of the change in pressure versus time in the abdominal cavity during the cycle of the device according to the invention.

5 is a graph of the volume of fluid removed to stabilize pressure as a function of time during the dwell period of the dialysis cycle, as measured using the APD device according to the present invention.

6 is a schematic diagram of a second embodiment of an APD device according to the present invention;

7 is a schematic diagram of a third embodiment of an APD device according to the present invention;

FIG. 8 is a preferred variant of the embodiment of FIG. 7 wherein the components are structurally coupled to the small cartridge.

9 is a schematic representation of a fourth embodiment of a device according to the invention.

Applicant's overall objective is to provide an automated peritoneal dialysis device capable of fully "customizing" the composition of the dialysate delivered to the patient to meet the immediate physiological needs of the patient and to monitor the effectiveness of the treatment during the course of treatment. This diagnostic information was used to optimize the custom manufacturing process.

The present invention particularly relates to a means for moving a solution of osmotic agent, electrolyte and other predetermined dialysate components from separate solution vessels into a mixing chamber means for providing a desired dialysis fluid which is bound in a proportion, and the dialysis fluid It is an object to provide an automated peritoneal dialysis device as described above, comprising means for delivering a predetermined amount of to the peritoneal cavity of a patient.

The present invention also provides an automated peritoneal dialysis device as described above, wherein said means for metering the dialysate components moving into the mixing chamber and delivering the dialysis fluid to the patient comprises means for removing the spent dialysis fluid from the patient. It aims to provide.

It is another object of the present invention to provide an electronic control in which said means for conveying fresh dialysis fluid to a patient and removing the spent dialysis fluid from the patient reacts in response to a signal for monitoring the pressure between the peritoneum and the signal of the pressure monitoring means. It is to provide an automated peritoneal dialysis device as mentioned above, including means, to regulate the rate of fluid injected into the patient, to remove fluid from the patient, and to custom-produce the dialysate.

A "basic" arrangement of the components of the device according to the invention is shown schematically in FIG. 1. The device is connected to the peritoneal cavity of the patient 10 via a patient tube line 12, which is a passage through which fresh fluid is injected and the spent fluid is withdrawn.

One of the essential components of the device according to the invention is the occlusion branch 14 and the hollow interior communication channel 16 of the occlusion branch is all fluid inlet lines connected to the vessel with the selected dialysate solution components. And communicate with an outlet tube line connected to the catheter and the drain.

In the arrangement shown in FIG. 1, eight separate inlet or outlet ports, which connect into the channel 16 of the cartridge 14, are numbered 1-8. The vessels (solution bottles) S1 and S2 hold sterile PD solutions with two different electrolyte compositions and are connected to cartridge inlets 1 and 2 by tube lines L1 and L2, respectively. While common in PD devices, an in-line heater 13 is provided to warm the sterile PD solution to body temperature. Containers S1 and S2 may optionally hold a standard PD solution (similar to glucose or osmotic agent).

The inlet 3 of the branch pipe 14 is connected by a line L3 to a container G1 which holds a very concentrated concentration of sterile osmotic agent (glucose solution or other known osmotic agent). The containers M1 and M2 are connected to the corresponding branch inlet by lines L4 and L5, respectively, and carry other drugs or additives to improve the clinical value of the solution in the containers S1 and S2. can do. The device according to the invention comprises a precise metering pump P1, the operation of which is described in more detail later. The patient line 12 mentioned above is connected to the inlet 7, while the drain line 15 is connected to the port 8.

In order to record and monitor the pressure between the peritoneum from time to time during the course of treatment, a pressure transducer means 17 is preferably included and the signal from the pressure transducer means is monitored by an electronic control means (not shown) for the device.

A preferred arrangement for the occlusion mechanism of occlusion branch 14 is shown in FIGS. 2 and 8. 2 schematically shows one tube connecting port 18 on which the inlet tube line L is mounted. The port 18 communicates with the internal communication channel 16 of the obstruction branch 14.

Each flexible sealing diaphragm 20 corresponding to the port 18 is located in the wall of the branch pipe 14, through the corresponding port 18 the channel 16, and the electronically adjusted plunger 22 opposite the wall. Enters.

Figure 3 shows an exploded view of the plungers 22 and 22c, the springs 22a and 22b and the motor 23 assembly for the assembly of the closure mechanism of the branch pipe of the automated PD device according to the invention. In the assembly, plunger 22 and plunger spring 22b are first inserted into branch pipe 14c. A cam 23a attached to an individual small rotary motor 23 is inserted into the branch pipe so that the plunger is held inside the branch pipe by the cam and the plunger is placed directly on top of the cam. The small spring 22a and the corresponding plunger head 22c are inserted into each plunger 22 through the branch pipe from the top. All the motors 23 are mounted on the motor mounting substrate 24. Two screws 24a are used to securely mount the motor-mounted substrate 24 to the branch pipe 14c.

Each motor 23 rotates the cam 23a associated therewith and the corresponding plunger 22c moves upward or downward along the cam. The up or down position of each of the individual plungers 22 can be electronically sensed and a signal is transmitted to the microprocessor means for stopping the motor in the up or down plunger position as appropriate. The tube connection port 18 ending in the channel 16 of the branch pipe 14 is arranged in line with the plunger 22c. The "up" position of the plunger has the effect of occluding the corresponding cartridge port, while the "down" position opens the port. Fluid flow is regulated according to the method described below.

The device can be controlled by microprocessor means (although not shown) with a stored memory for on-line monitoring of information and programming operating parameter settings. Removable memory cards can also be combined to ensure easy collection and transfer of treatment data for the patient. Optionally, during and after PD treatment, an interactive voice interface and a visual and audio alert system can be combined to simplify the diagnosis of the disease.

The microprocessor means are programmed to receive signals from various detectors and to produce output adjustment signals for adjusting the metering pump P1 and plunger 22 via electromechanical means such as the motor / cam arrangement described above. .

During dialysis, the predetermined fluid filling volume of each cycle is programmed into the microprocessor. Corresponding proportions of drugs and / or additives are also programmed. Initializing the operation of the device, all the inlet and outlet ports of the cartridge 14 are closed by their respective plungers. These plungers are individually controlled by their respective motors. When the plunger 22c moves upwards (ie toward the branch pipe), the plunger pushes the flexible diaphragm 20 and closes the outlet of the port tube 18 in the channel 16 of the branch pipe, To prevent fluid from entering or exiting the chamber. Moving the plunger downward allows the tube outlet to communicate with the chamber, allowing fluid to flow freely into or out of the chamber and to communicate with another outlet that is also open at that time.

Referring specifically to FIG. 1, the microprocessor electronic control means is programmed to open the eighth port (connected to the drain line 15) and the sixth port (connected to the pump line of the metering pump). Subsequently, the plungers corresponding to the first, second, third, fourth, and fifth inlet / outlet ports operate to operate the first, second, third, fourth, and fifth ports at a predetermined time. It will open and close. During the open period, the metering pump P1 operates to draw the fluid in from each container and to dump them into the drain. The patient line 12 opens one of the first or second ports and the sixth port to draw fluid from one of the vessels S1 or S2 and then closes one of the first or second ports, and the seventh port. Is flushed by opening and injecting fluid into the patient line 12.

For the efficient operation in drawing the calculated volume of fluid from the vessel and injecting the withdrawn fluid to the target point, the metering pump (whether the vessel and the target point is vertically above or below the device) It is essential for P1) to provide positive displacement and have a known volumetric displacement. One method that has been applied in practice has been to have the metering pump P1 have various volumetric displacement mechanisms. Various movements can be obtained by controlled linear movement of the volume moving member. This type of motion can be achieved by connecting a worm gear to the output drive shaft of the electric motor. The controlled rotational motion of the electric motor is smoothly converted into a regulated linear motion which then regulates the volumetric movement of the pump.

A common example of this type of metering pump is a syringe pump with controlled linear movement of the plunger in the syringe barrel. The linear motion (volume movement) of the metered syringe pump was calculated by the following method. The inner shaft on the electric motor is digitally encrypted. Its rotational position was optically sensed to generate a set of electrical pulses whose number of pulses was directly proportional to the linear movement of the worm gear. One particular form used in this method was to provide 20 cc of fluid movement every 2.15 inches of linear motion of the worm gear. The lead screw of the worm gear was propelled through the gearbox with a lead of 0.12 inches (gear ratio 81: 1). The motor's encoder produced 512 pulses / revolution. Through connection with the motor shaft coder, the microprocessor control means could detect each pulse generated by the coder. In principle, this weighing system has a sensitivity of 30 × 10 ^-9 liters. This is at least three times more precise than what is required in the APD device according to the invention for achieving the metering purpose. In general, one skilled in the art will be able to manufacture a plurality of variations of this particular device.

If the solution S1 is selected during the fill state, the first and sixth ports are opened and the metering pump will operate to draw the correct amount of fluid from the vessel S1. After the above is done, the first port is closed, and the correct volume of the predetermined additive G1 selected by the opening of the third port enters the pump P1, after which the third port is blocked. Continuing in this manner, it is possible to gradually add fluid from the vessels M1 and M2 into the pump. The seventh port is then opened to inject the metered fluid composition into the patient and the metering pump injects fluid into the patient's peritoneal cavity while the device monitors the volume of fluid slowly being injected into the patient.

This injection procedure is repeated several times until the exact total amount of dialysis fluid is delivered or until some other desired condition is achieved. An example of such a predetermined state is shown at point P ₂ in FIG. 4. During the fill state, the intraperitoneal pressure will slowly increase from T ₀ to T ₁ in proportion to the filled volume. There is a curvature increase in pressure at the maximum fill volume obtained at the time past T ₁ and the corresponding pressure P ₂ . The device will be programmed to remove enough fluid to reduce the pressure from the maximum P ₂ to a safe and regulated pressure level P ₁ . This is the steady state pressure for the monitoring process. The official dwell period then begins at T ₂ .

Entering the dwell period, all ports of the bifurcation are blocked, and the pressure change between the abdominal cavity from the signal transmitted by the in-line pressure transducer 17 is sensed by the microprocessor. Any ultrafiltration that occurs (drawing fluid from the patient's body into the peritoneal cavity) will inevitably result in an increase in pressure in the peritoneum, which detects and signals the control means to open the sixth and seventh ports. The pump will then inhale sufficient fluid, ie, an excess amount, from the patient's peritoneal cavity until the steady state pressure level P ₁ is restored. The volume removed during the dwell period is recorded by the computer as "superfiltration" in terms of time spent. Each time the pressure reaches P ₂ , the pump operates to reduce the fluid volume sufficient to drop the pressure to a steady state P ₁ . This volume V _f is recorded over time t ₂ (the length will depend on the osmotic pressure of the fluid). This action works as often as necessary.

The process for restoring this steady state pressure and the process for recording the accumulated volume of fluid removed as a function of time to do so are carried out automatically through the dwell period, and the measured value of the accumulated ultrafiltration (UF) Is recorded. Measurement of the graph of pressure versus time in the abdominal cavity provides valuable diagnostic information. When the pressure does not change from its steady state value for a certain time, it can be inferred that the dialysis fluid no longer performs its optimal clinical function. At such time, T ₃ (FIG. 4), the fluid can be safely discharged out of the patient's body without any further time wasting. However, the onset of pressure reduction may indicate that the patient is absorbing fluid from the peritoneal cavity, and may indicate that the patient is absorbing glucose from the dialysate, or that the dialysate leaks into extra abdominal tissue. can do. This unwanted clinical condition can be avoided by arranging the control logic of the device to automatically drain all spent dialysis fluid volume from the patient when such a pressure drop occurs.

The sixth and seventh ports are opened during the drain phase. The metering pump P1 draws the consumed fluid from the patient to the syringe. This volume is measured while drawing the fluid. When the syringe is full, the seventh port is blocked and the eighth port is opened. The pump P1 reverses the direction and pushes the waste fluid from the syringe through the drain line to the spent dialysate reservoir. This works until all fluid is drained or the pressure has recorded negative, or until the set drain time ends. The final UF is then measured by the device.

This completes one dialysis cycle. The procedure is repeated the required number of times until the desired therapeutic amount is obtained.

Another important feature of the present invention is the ability to provide clinical information that is determined based on the patient's real time physiological needs or is not obtainable in advance. A graph of on-line monitoring of fluid volume removed to stabilize pressure at steady state is provided in FIG. 5 as a function of time during the dwell period of one dialysis cycle, which is an example of new clinical information. The present invention allows the normal set dwell times T ₂ to T ₃ to be ideally adjusted. At the maximum UF volume, V _m , the dialysis fluid reached equilibrium with the intraperitoneal plasma. Therefore, any time above T _x can be a waste of treatment time. The clinician can program the device to automatically drain the fluid consumed from the patient and supply fresh fluid for better dialysis, or use the information to set a more effective dwell time for the next treatment. In other cases, if the set dwell time ends at the rising stage of the ultrafiltration curve, the dialysate is not properly used. These are examples of the device's ability to automatically determine based on the patient's real time physiological needs. This graph also reflects the real time solute and fluid transport rate of the peritoneum for any given dialysate composition. That is, the greater the efficiency of the peritoneum, the larger the initial slope of the ultrafiltration curve, and a faster T _x time is obtained. For the first time, clinicians will be able to quantify the transport characteristics of the peritoneum online and use this information to directly control the device, or allow the device to automatically make the necessary adjustments.

Another example of the ability of a device according to the invention to provide previously unobtainable clinical information and / or a method of processing such information by the APD device is as follows: In clinical PD applications, the active surface area is The peritoneal characteristics, and permeability (solute and fluid transport), are all variable for any given patient and are largely unknown. Therefore, methods for quantifying peritoneal operation have been developed. However, these methods are complex, indirect, and none of these procedures are online. Two methods used to assess peritoneal behavior are (a) peritoneal Membrane Mass Transfer Area Coefficient (MTAC) and (b) Peritoneal Equilibration Test (PET). The latter (PET) is the most commonly used method to determine the ratio of dialysate to plasma (D / P) of a given solute and to evaluate patients. Most preferably, do this once a month. It is not possible to obtain data to run PET at various stages of the dwell period during current treatment. If such data are available now, it may lead to a better clinical understanding of the various ultrafiltration failures. Combining the unique ability of the device according to the present invention to safeguard fluid samples at known correlation points on the ultrafiltration curve during dwell, clinicians will be able to better evaluate PD treatment in vivo. This is a major advance in the field of PD therapy. A related clinical benefit is that clinicians will be able to immediately show the change in the ultrafiltration curve and the relationship between the form or the additive of the drug during the treatment cycle.

It will be appreciated from the above description that the pressure monitoring operation used to adjust the UF using the device according to the invention makes it possible to implement true periodic peritoneal dialysis. By maintaining the pressure at the initial fill pressure P1 it can be inferred that the actual volume of fluid in the peritoneal cavity is equal to the initial fill volume. This volume is already known. For the first time, the APD device will be able to use the actual volume of fluid in the peritoneal cavity rather than the pre-evaluated amount to determine the actual periodic variable release and reinjection volume. This is a major advance in the art.

Furthermore, additional detectors and detectors, their signals taken into account in the program microprocessor, or diagnostic and therapeutic advantages may be included in the system. For example, a turbidimeter comprising a photodetector that monitors the transparency of the emission during the light source and drain allows for early detection of the onset of infection. If the patient line 12 passes between such a light source and a photodetector, it will be possible to detect whether the patient's emissions are turbid during draining due to the onset of peritonitis (level of white blood cells dispersing light caused by infection). Provide an increase). The detector delivers this information to the microprocessor and an audible and visual alarm is initiated, and the device is directed to empty the metering pump P1 and the cloudy sample of collected material for further analysis.

The device can thus be programmed to make an important decision about the type of injection based on the signal from the sensor reflecting the composition and pressure of the fluid in the peritoneal cavity.

Although the “basic” device shown in FIG. 1 uses a metering pump to draw and carry the assigned dialysis fluid components, the arrangement is a sterilized fluid and drug from a container held vertically above the patient, without any metering pump. To release them, they may be used using a gravimetric system and gravity, with a weighing container located underneath the patient to measure the volume.

Equally effective, although the basic apparatus is designed to custom-produce dialysate from a plurality of solution vessels, the apparatus is in a non-customized form, ie pre-mixed dialysate in each of one or more vessels. Can be used with Each port may be connected to a dialysate of fixed composition. The described diagnostic capability of the device is then used to select which port to connect to the patient line 12 for infusion into the patient, to determine the dwell duration, and to use the metering pump to release the selected formulation from the patient. Can be used to

A second embodiment of a PD device according to the invention is shown schematically in FIG. The same reference numerals are used in FIGS. 6 and 8 to be described below in order to specify device components which are generally similar and function the same as components described in the same numbers in the basic apparatus shown in FIG. 1.

As shown in FIG. 6, the second preferred embodiment relies on the pump P1 to achieve a compact arrangement and features in easy clinical use and portability. The cartridge is divided into two distinct chambers 14a and 14b. The first chamber houses the first, second, third, fourth, and fifth ports. The second chamber houses the sixth, seventh, and eighth ports. Fourth and seventh ports are connected to the metering pump P1 via one-way valves V1 and V2 for fluid inlet and outlet, respectively. Most of the sterilized neutral fluid S (no osmotic agent) is connected to the first port via a heater 13. Osmotic agent G1 (ie, glucose, etc.) is connected to the second port and drug M1 is connected to the third port. Inflow into the patient is at port six and outflow from the patient is at port five. The fifth and sixth ports are coupled to the patient line via pressure transducer means 17.

In operation, all ports are initially occluded. The first, fourth, sixth, and seventh ports are opened during the fill phase. Fresh fluid is withdrawn from S by pump P1, passes through the heater, and passes through valve V1. At a given volume the first port is occluded and the second port is opened so that the correct amount of osmotic fluid is also drawn into the metering pump. Thereafter, the second port is blocked, and the third port is opened to draw a predetermined volume of the drug M1 into the pump P1. The third port is then blocked. Reversely, the contents of the pump P1 flow into the patient via the valve V2, the pressure transducer 17, and the patient line 12. The procedure is repeated several times until the correct dose volume is delivered to the patient. By having the one-way valves V1 and V2, the opening and closing frequency of the fourth, fifth, sixth and seventh ports is reduced.

Only the fourth, fifth, seventh and eighth plungers are opened during the drain stage. The fluid consumed from the patient is drawn into the pump P1 through the patient line, the pressure transducer 17 and through the fifth, fourth port and the valve V1. The syringe P1 thus measures the fluid drawn out. The feedback of the pressure transducer regulates the proportion of fluid withdrawn from the patient by the pump P1. When the pump P1 is full, the pump P1 is finally drained and emptied through the valve V2, the seventh and eighth plungers. All of the operations mentioned above are equally applicable to this embodiment. If the first, second, third, fifth, sixth and eighth plungers are all occluded, the fourth and seventh plungers are strictly necessary because the metering pump is isolated and there is no fluid movement. It is not.

The device according to the second embodiment can be operated from an ordinary table top or a short stand, with the solution and drug conveniently located underneath the main device. The device can even be operated at the bottom level. It is evident that the volumetric pump P1 does not depend on the relative vertical position of the solution, the patient and / or the final drainage, as in the case of a gravity-injection cycler, as in the gravity-injection cycler. It thus provides a new device that can be used universally for patients lying in bed, hospital bed or floor mat.

The third preferred embodiment is as shown in FIG. The component arrangement is similar to the first embodiment shown in FIG. 1 (basic device) described above. The sterile PD solution (only electrolyte) is in the first port. Osmotic agents (G1, G2) are in the second and third ports. Drug M1 is in the fourth port. Patient line 12 is regulated by a fifth port. The sixth port regulates the drain line 15. The metering pump P1 communicates directly with the entire occlusion chamber. The fluid flowing into and out of the metering pump P1 passes through the pressure transducer chamber 17 ′ in communication with the pressure transducer 17. All tube lines are in communication with the obstruction branch 14. In the line, in the connected vessel, or in the patient and in the drain line, the pressure is all monitored by opening the appropriate port. Using this arrangement, detecting other important conditions in addition to all those already mentioned in the above embodiments; The pressure measurement can be used to detect (a) empty solution vessels (S, G1, G2, and M1) (b) obstacles in the drain line and (c) obstacles in the patient line.

An “small cartridge” embodiment of the system of FIG. 7 is as shown in FIG. 8. The block 14, heater and metering pump P1 are all combined in one small cartridge. The heating chamber has two zones; It is divided into an initial heater chamber 13a which receives the incoming cold solution and a corrugated heater section 13b which leads the fluid passage to ensure proper heating of the solution. The outlet of the heater is attached to the first port.

A preferred embodiment of the new APD device is as shown in FIG. The operation of this embodiment is the third in FIG. 7 except that there are two additives in this embodiment, namely (a) the emission detector 28 and (b) the sample collection port (at the sixth port). Same as described above for the embodiment. The drain line 15 is now located at the seventh port.

The emission detector comprises a light source 28a facing the light detector 28b. Changes in light intensity are detected by the photodetector and a signal is passed to the microprocessor for proper operation.

The patient line 12 passes between the light source 28a and the light detector 28b of the emission detector 28. Thus, during the drain, if the patient's emissions become cloudy (initiation of peritonitis; due to infection-products of leukocytes), the light entering the photodetector is dispersed. The detector thus forwards the message to the microprocessor. Both auditory and visual alerts are initiated. If this situation occurs, the device automatically opens the sixth port at the moment of emptying the metering pump P1 and transfers the turbid effluent solution sample into the sample collection vessel 30 (which may be a bag or a syringe). send. The sixth port will then be blocked and the normal drain procedure will continue by activating the seventh port.

If the device is set up to begin peritonitis treatment, a rapid peritoneal lavage (filling immediately after draining) will be performed. After treatment, the fill volume containing the drug or drugs is then automatically measured from the drug container, such as the container M1, by means of a metering pump P1.

Similarly, the release detector detects excessive amounts of blood in the discharge (usually with new catheter surgery or with a new catheter prototype) to automatically reduce the amount of heparin additives or to reduce the volume of dialysate injection. Can be programmed.

While particular embodiments of the invention have been described in connection with the accompanying drawings, it will be apparent to those skilled in the art that changes and modifications may be made without departing from the spirit of the invention as defined in the following claims. will be.

Claims (16)

An apparatus for performing peritoneal dialysis for a patient in which the peritoneal cavity of the patient is in communication with at least one patient catheter, (a) a branch pipe comprising a plurality of liquid inlet / outlet ports; (b) occlusion means for selectively occluding and reopening communication between one or more of said inlet / outlet ports and another port of said branch pipe; (c) metering means in communication with at least the first one of the inlet / outlet ports, capable of withdrawing and measuring a predetermined amount of liquid volume from the branch pipe; (d) a mixing chamber in communication with the branch pipe; (e) a patient conduit line for connecting at least a second one of said inlet / outlet ports to said patient catheter; (f) a conduit line for connecting the remainder of said inlet / outlet port to each reservoir of dialysate solution components; And (g) means for adjusting said blockage means and said metering means to draw a selected volume of each of the selected components of said dialysate component by said metering means to provide a dialysis solution in said mixing chamber having a predetermined final composition Device comprising a. The method of claim 1, wherein the means for adjusting the occlusion means and the metering means causes the selected volume of dialysis solution of the final composition to be injected into the peritoneal cavity line of the patient through the patient conduit line at the fill step. And electronic control and sequencing means for withdrawing from the peritoneal cavity to the metering means after the first selected time in the dwell stage. 3. A drainage conduit line according to claim 1 or 2, further comprising a drain conduit line for connecting a third one of said inlet / outlet ports to a reservoir for spent dialysate, wherein said electronic control and arrangement means comprises said first selected time. And all or part of the spent dialysis solution drawn into the metering means in a later drain step is operable to be injected into the reservoir through the drain conduit line. 4. The metering means according to any one of claims 1 to 3, wherein the metering means is in response to a control means from a fluid delivery means comprising a pump mechanism and a calculated volume of various means and from the electronic control and arrangement means. And electromechanical drive means operable to change the volume of the storage means with a program of stepwise increase or decrease of the calculated volume. 5. The method of claim 4, wherein said metering means comprises a syringe pump having said syringe plunger and electromechanical drive means for stepwise forward or backward of a syringe plunger in response to a control signal from said electronic control and alignment means. Device characterized in that. The electronic device according to any one of claims 3 to 5, further comprising: means for monitoring the pressure in the peritoneum of the patient and the electronic for use in determining and performing operating steps of the device suitable for a given treatment of the patient. And means for providing a first monitoring signal to the adjusting and arranging means. The method according to any one of claims 3 to 6, wherein said electronic control and arranging means for use in determining and performing operations of said device suitable for the desired treatment of said patient, in said patient conduit line at a selected time. And electro-optical means for producing a second monitoring signal indicative of turbidity of the fluid. Maintaining the liquid pressure in the peritoneal cavity at a predetermined value by removing excess liquid from the peritoneal cavity or injecting additional dialysate solution into the peritoneal cavity in response to pressure changes in the peritoneum. A method for performing peritoneal dialysis of a patient in which the lumen is in communication with at least one patient catheter. A method for performing peritoneal dialysis of a patient in which the peritoneal cavity is in communication with at least one patient catheter, (a) a device comprising a branch pipe having a plurality of liquid inlet / outlet ports, Occlusion means for selectively occluding and reopening communication between at least one inlet / outlet port and another port of the branch pipe; Metering means in communication with at least a first one of said inlet / outlet ports, said metering means operable to draw and measure a volume of liquid volume from said branch pipe and to inject a volume of a selected liquid into said branch pipe; Means for injecting a predetermined amount of liquid volume from said branch pipe into a mixing chamber; A patient conduit line for connecting at least a second one of said inlet / outlet ports to said patient catheter, and Providing a device comprising a conduit line for connecting the remainder of said inlet / outlet port to each reservoir of dialysate solution components; (b) electronic control and arrangement operable to control the operation of the occlusion and metering means and to transmit a monitoring signal to the electronic control and alignment means in combination with the sensing means to indicate the state of the liquid in the peritoneal cavity of the patient; Using means, wherein in the form of automation the adjusting and arranging means (i) drawing a selected volume of each of the selected components of the dialysate solution component by the metering means to provide a dialysate solution to the mixing chamber having any predetermined final composition, (ii) continuously inject the selected volume of dialysis solution into the peritoneal cavity through the patient catheter at the fill step, (iii) withdrawing at least a portion of the dialysis solution spent after the selected dwell time during the dwell step from the peritoneal cavity into the metering means. 10. The method of claim 9, wherein the selected dwell time is determined based on a monitoring signal transmitted by the electronic regulation and alignment means. 11. The method of claim 9 or 10, wherein the device provided to perform the method further comprises a drain conduit line for connecting a third one of the inlet / outlet ports to a reservoir for depleted dialysate, Adjusting and arranging means being used to drain all or part of the spent dialysis solution into the metering means and inject into the reservoir through the drain conduit line in a drain step after the first selected time. How to feature. 12. The method of claim 11, wherein said sensing means comprises pressure transducer means for producing a sensing signal indicative of pressure in the abdominal cavity in said patient. 13. The method of claim 11 or 12, wherein said sensing means comprises electro-optical means for producing a sensing signal indicative of turbidity of fluid in said patient conduit line. 13. The method of claim 12, wherein the automated form of operation is in response to a sense signal from the pressure transducer means such that the device removes excess solution from the peritoneal cavity or injects additional dialysate solution into the peritoneal cavity. Maintaining the liquid pressure at a predetermined value. The method of claim 14, further comprising measuring the volume of the solution withdrawn from the peritoneal cavity of the patient as a function of time to continue to maintain a constant intraperitoneal pressure to characterize the peritoneal delivery characteristics of the patient being treated. Method comprising a. 16. The method according to any one of claims 9 to 15, wherein during said dwell step, a selected amount of dialysis fluid is withdrawn from the peritoneal cavity a predetermined number of times to stir and homogenize the fluid, and back to the peritoneal cavity. How to.