JPS5929264B2 - artificial kidney - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to an engineered kidney for removing toxic substances from body fluids such as blood or peritoneal fluid.

In recent years, the use of devices of this type has extended the lifespan of people with damaged or malfunctioning kidneys.

Iruma's renal physiology has already been clearly elucidated, and its function is to remove non-volatile substances from the blood stream and constantly adjust the composition of the blood in order to maintain the conditions of the body's tissues necessary to support cell life. That's true.

Therefore, if the kidneys are not functioning properly, some type of artificial device must be used to perform these functions to avoid uremia and electrolyte imbalances.

Once this condition occurs, the blood flow quickly becomes toxic.

Artificial kidneys have been developed to the point that they can be used several times a week for a few hours to reduce the concentration of toxic substances in the blood.

By introducing a wash solution into the prosthesis that is carefully formulated to be isotonic with the blood, certain desirable blood compositions, such as electrolyte components, are not lost.

Several challenges arise when using this type of conventional equipment.

First, a large amount of cleaning solution is required.

This bulk cleaning solution is generally supplied from a fixed, large capacity reservoir.

Second, these devices can only be used intermittently.

Dialysis for less than 6 hours twice a week is not effective, and patients cannot move during dialysis.

An unavoidable undesirable fact of intermittent use is the periodic generation and removal of waste products.

Immediately before using a conventional artificial kidney, the concentration of various solutes in the patient's blood is abnormally high, but immediately after the procedure, the undesirable effects inherent in the conventional method result in imbalanced concentrations in the body.

Third, conventional devices are expensive and require trained personnel to use.

U.S. Pat. No. 3,579,441 basically solves many of the problems of conventional artificial kidneys.

This patent describes the combination of filtration devices to perform normal renal functions.

Arterial blood is first filtered through a series of highly selective ultrafiltration membranes designed to retain high molecular weight blood elements while passing blood water and low molecular weight toxic solutes.

The P solution containing water and solutes then passes through multiple thin membranes that are uniformly fine and ultrafiltration, allowing only pure water to pass through as lachrymal fluid while retaining toxic solutes in the membranes.

The solutes retained by this superfilter are discharged as waste, and the purified P fluid, which mainly consists of pure water or pure water and electrolytes, mixes with the high molecular weight blood elements retained by the superfilter. and returned to the vein.

Since a certain amount of the desired electrolyte is lost during filtration, a controlled amount of replenishing electrolyte solution must generally be added to the cleaned p-fluid to make it isotonic with the blood.

Although this new combination filtration device represents an important improvement in technology by providing an effective, continuously usable, and conveniently attached to the body artificial kidney, it still faces some problems.

For example, if a selective superfilter is first used that retains high molecular weight substances and allows low molecular weight solutes to pass through, the high filtration rates required for efficient operation of the filter may cause membrane failure. It has arisen.

This problem can be avoided by reducing the filtration rate, but of course this will reduce the efficiency of the device.

Additionally, large surface areas, typically about 2000 CrrL2, have been required to achieve effective and efficient filtration rates in ultrafilters.

It was necessary to periodically add replenishing electrolyte to the purified p-liquid which was then returned and mixed with high molecular weight substances, which became a source of blood contamination.

Also, the water used in this solution had to be handled with care to ensure that it was sufficiently sterilized and did not become a source of heat.

In one embodiment of the invention, the above-mentioned drawbacks are largely eliminated and the previously described filtration device is improved by using a hemodialysis device instead of an ultrafilter.

Instead of purifying the blood by passing it through a single filtration device, toxic substances are removed and the blood is purified by passing it through a dialysis membrane.

In a hemodialyzer, a well-standardized dialysate containing water and a certain concentration of electrolytes is passed through the membrane to selectively diffuse unwanted toxic substances into the dialysate. is passed along one side of the membrane in the opposite direction.

The dialysate should preferably have electrolyte concentrations and water similar to blood to prevent interdiffusion during hemodialysis.

Blood purified in this manner can be directly returned to the vein without the initial volume of water, electrolytes or other desirable constituents being reduced, as occurs in conventional ultrafilters.

The used dialysate is processed by equipment similar to that used in the prior art devices described above to remove toxic substances and recirculated to the hemodialyzer as reconstituted dialysate, which is conveniently carried by the user at all times. We supply robust and portable equipment that can.

In the device of the present invention, the dialysate containing the replenishing electrolyte circulates through a closed system route separate from the blood system route, thereby eliminating a source of blood contamination that would otherwise occur when the replenishing electrolyte solution is directly added to the veins. are doing.

Furthermore, because the blood is purified by the diffusion of toxic substances from the blood, rather than by passing the substances through the filter as solutes in the blood water, the high filtration rates required by conventional devices are not achieved. The large surface area can be significantly reduced and the device according to the invention can be made more efficient in both scale and performance.

As a specific example other than the above, an artificial kidney that can be worn on the human body according to the present invention is used as an applied device for peritoneal dialysis, which draws peritoneal fluid from the peritoneum and recirculates it from the body. Toxic substances are removed by diffusing from the blood into the peritoneal fluid through the peritoneal membrane, reducing the concentration of these toxic substances in the blood.

Body fluids suitable for use in the kidney according to the present invention include arterial blood as well as peritoneal fluid, as specified in the specification and claims.

If the kidney is used with peritoneal fluid, a cannula is inserted into the peritoneal cavity rather than an artery, and a circulation pump is used to draw the peritoneal fluid and send it to the kidney's dialysis machine.

When the kidneys are used with blood, a pump is not needed because the body's heart provides the necessary pressure to pump the blood to the dialyzer.

As the peritoneal fluid passes through the dialyzer, it is cleaned in the same way that blood is cleaned by the dialyzer, and a replenishing solution is added to the dialysate that is returned to the dialyzer as well.

Therefore, the artificial kidney of the present invention can be used for both peritoneal fluid and blood without changing the structure of the device.

A preferred embodiment of the invention comprises a dialysis machine, an ultrafiltration system for dialysate purification, a high pressure pump, a metering pump, and a small reservoir for make-up electrolyte solution.

These components can be combined to form a compact device that can be attached to the body for almost any purpose such as sleeping, free movement, daily toileting, sexual activity, and more.

More specifically, in the artificial kidney of the present invention, arterial blood or peritoneal fluid from the peritoneum is withdrawn and directed to one side of the membrane of the dialysis machine.

The aqueous dialysate, which does not contain toxic solutes in the blood, flows along the other side of the dialysis membrane in the opposite direction to the body fluid to form a concentration gradient, causing the toxic solutes to diffuse into the dialysate.

Dialysate is constantly discharged through the dialyzer device, so that the concentration of toxic solutes during dialysis never reaches a concentration equivalent to that of the body fluid being treated and a strong concentration gradient is always maintained across the membrane.

The dialysate is carefully formulated so that it is not only free of toxic solutes, but also contains substances that are desired to be retained in the blood at concentrations nearly identical to those in the blood.

Desirable substances include glucose, sodium chloride,
Sodium bicarbonate, potassium, and other preferred electrolytes.

The dialysate therefore does not develop concentration gradients of these substances to prevent their loss from body fluids.

The used dialysate, which contains toxic solutes, is pumped from the dialyzer to a dialysate purification ultrafiltration device that allows only water and electrolytes to pass through.

The purpose of ultrafiltration devices for dialysate purification is to remove urea, uric acid, creatinine, and other toxic solutes from used dialysate.

The superfiltrate contains relatively pure water and is recycled and reused to become dialysate for the dialysis machine.

The unfiltered retentate retained by the ultrafiltration device is waste and is stored in a small container and periodically discarded.

During use, most of the electrolyte is released as P along with some of the water and is retained and stored together with the waste.

A small amount of highly concentrated aqueous electrolyte solution is supplied from a make-up electrolyte reservoir and mixed with the purified dialysate P fluid by a metering pump to provide the reconstituted dialysate as needed for use in the dialysis machine.

The metering pump delivers a predetermined amount of an electrolyte-rich aqueous solution, such as sodium chloride, potassium, or sodium bicarbonate, to the purified dialysate to make it isotonic with the blood.

= In general, most of the replenishment solutions are concentrated salt-containing substances.

If peritoneal fluid is used, the metered replenishment solution added to the dialysate for return to the dialyzer must contain glucose or sorbitol at a concentration of about 1% by weight.

Glucose or sorbitol, which is introduced into the peritoneal fluid through the membrane of the dialyzer, is known to those skilled in the art of peritoneal dialyzers because of the osmotic introduction of water from the body into the peritoneal fluid. bring.

This introduction of water is necessary because the artificial kidney according to the invention rejects water, which is supplied by drawing water from the body into the peritoneal fluid.

The net effect of the integration of all the elements of this invention is to mimic normal kidney function by retaining plasma, water, and concentrated electrolytes in the blood while discarding nitrogenous waste. That's true.

If dissolved sugar disappears, it is replenished orally.

In another embodiment of the invention, the method described above is simplified and the need for tampering with the used dialysate is eliminated.
Only one circular circulation loop is provided.

To explain further, when the fluid to be used is peritoneal fluid, an external circuit is used to purify the dialysate by superfiltering the peritoneal fluid containing toxic substances and then returning the reconstituted superfiltrate to the peritoneal cavity. Can be omitted.

Compared to the previous case where either peritoneal fluid or blood can be used and both body fluids and dialysate are cleaned and recirculated, this method can only be used when using peritoneal fluid and not blood; only is purified and circulated.

A second embodiment of the invention therefore provides a process for circulating a preconditioned solution through the peritoneal cavity to remove toxic metabolites from blood passing through the peritoneal membrane into a solution constituting the peritoneal fluid; a process of removing the liquid;
It consists of a process of retraction filtration of peritoneal fluid to remove toxic substances from the fluid, a process of reconstituting the filtered peritoneal fluid and recirculating it into the peritoneal cavity, and a process of discarding waste materials.

The foregoing general description and the following detailed description are specific examples and are not intended to limit the scope of the invention in any way.

The accompanying drawings illustrate embodiments of the present invention, and the principles of the present invention will be described in detail below with reference to the drawings.

Figures 1-8 describe the treatment of arterial blood.

As mentioned above, in the artificial kidney of the present invention, peritoneal fluid from the peritoneal cavity may be used as a substitute for blood.

Peritoneal fluid is the natural fluid present in the peritoneum and may be supplemented with peritoneal dialysis solution to increase the volume if necessary.

Regarding peritoneal dialysis, especially recirculating dialysis, as a means of carrying out the functions of the natural kidney, "Transa
tions of American 5ociet
yof Artificial Internal O
J, H, Shinaberg, published in ``Rgans'' (Vol. 2, pp. 76-82, published 1965).
Mr. er, 5hear K, G.

Mr. Barry's paper '''Increasing Ef.
f1scienceofPeritonealDia
Please refer to "Iysis".

In FIGS. 1A and 8, arterial blood is withdrawn from the body by a conventional cannula 10 and pumped by the heart into a dialysis machine or hemodialyzer 12.

At the same time, fresh dialysate 14 is pumped through the dialyzer 12 in a direction opposite to the blood flow and used dialysate 16 is drawn from the dialyzer by the low pressure side of the high pressure pump 81.

FIG. 2 shows the detailed structure of the dialyzer 12, which will be described in detail below.

The dialysate 16 is fed from the input side 21 through the pump 81 to the retraction filter 60, 60' in FIG. 8, from the high pressure side of the pump.

The retracted filtrate 17 from the retracted filter 60 mainly contains pure water and electrolytes, while the non-permeable solute 15 is stored in a removable toilet bowl 151.

In FIGS. 3A and 3B, the retracted filtrate 17 from the retracted filtrate 60 is always withdrawn continuously across the E plane 63, while the used dialysate 16 under pressure is removed from the inlet tube 21.
It passes through the retraction lacrimal apparatus parallel to the r-plane 63 and is discharged as a concentrated solution 15 of low molecular weight solutes such as urea, creatinine, uric acid and electrolytes.

The pressure within the retraction lacrimal device 60 is maintained at an appropriate value by the pump 81 and the pressure regulating valve 153 in the urine drainage system 15.

Regulating valve 153 is designed to allow a continuous flow of used dialysate to pass through retraction filter 60 and to continuously discharge waste stream 15 to toilet bowl 151 .

Due to the large volume of the receding filtrate 17, the volume of the waste 15 is at a manageable proportion and the toilet bowl 151 needs to be removable and emptied from time to time as needed.

Pump 81 applies pressure to retraction filter 60 as previously described.

The pump and metering device 93 is driven by a power source 182 consisting of an AC or DC motor 82 (a DC motor is preferred in the case of a body-attached device) and a rechargeable storage battery.

The retracted lachrymal fluid 1 from the retracted filter is introduced into the introduction part of the measuring device 93.
Concentrated replenishment electrolyte solution 1 from the replenishment storage tank 193 along with 7
95 is introduced and returned to the hemodialyzer 12 from an outlet 196, where sodium, potassium, bicarbonate, phosphate, chloride, sulfate ions, etc. are reconstituted to have predetermined concentrations. Liquid 14 is extruded.

The purified whole blood returns to the body through venous cannula 18.

FIG. 2 clearly shows the detailed internal structure of the dialyzer 12 according to the invention.

In this perspective view, arterial channel 45 and dialysate channel 5
Only two pieces of 3 are shown in fragments.

In reality, the hemodialyzer of the present invention includes multiple blood and dialysis channels.

Although the illustrated example is an arrangement of membranes, other arrangements may be used, for example, flow filter tubes in which the blood and dialysate flow in opposite directions parallel to the longitudinal axis of each tube.

In either case, the polarization effect on the surface of the blood channel is negligible for sufficiently small dimensions.

As shown in FIG. 2, the laminated structure of the thin membranes consists of a thin membrane 43, a porous support forming a dialysate channel 53, and a parallel array of cylindrical spacers 41, with two adjacent thin membranes 43
The space in between becomes a blood channel 45.

Various membranes suitable for hemodialysis and well known to those skilled in the art may be used as the membrane element 43.

Examples include cellophane copper fans, polyvinyl, alcohol resins, and cellulose acetate.

When selecting a thin film, it is desirable to use a thin film containing heparin or other anticoagulant.

The materials used in the hemodialyzer 12 that come into contact with blood should be non-thrombogenic, ie, non-clotting.

The required non-thrompogenic materials include heparinized polytetrafluoroethylene, heparinized surgical silicone, and the like.

A suitable material for the spacer 41 is polytetrafluoroethylene monofilament, which is manufactured by DuPont under the trade name "Tef Ion".
It is commercially available as ``TFE'' or ``Tef Ion FEP''.

However, since the porous support material constituting the dialysate channel 53 does not come into direct contact with blood, nylon or other equivalent material may be used.

A suitable thickness for channel 53 is approximately 50-150 microns.

Blood channels 45 between membranes 43 should be as small as possible, suitably up to about 7 microns, the size of a red blood cell.

Channel 45 thus ranges from about 7 to 100 microns.

Arterial blood flows through a blood channel 45 parallel to the spacer 41.
, which is in the opposite direction to the flow of dialysate flowing through the dialysate channel 53 .

Toxic blood solutes with molecular weights less than 10,000 are thin film 43
The used dialysate 16 containing toxic solutes is continuously discharged from the opposite side of the hemodialyzer 12 .

The hemodialyzer is 16X6X0.8crfl. It is housed in a rectangular box with a capacity of about 15X5XO05CrfL and a weight of about 100mm. It is.

Retraction filter 60, shown in FIG. 3A, is designed similar to the laminar assembly of dialyzer 12, but acts more as a filtration filter than as a dialyzer.

This assembly consists of an assembly of spaces 65, a thin film 63 surrounding this space, and a perforated plate 67 that supports this thin film.

Between the perforated plates 67 is a space 69 from which the retracted filtrate is drawn off via a branch pipe.

This regressed filtrate 17 mainly consists of pure water or pure water and an electrolyte.

The inlet tube 21 draws the used dialysate from the hemodialyzer and passes it through the space 65 by means of a pump 81 .

Pure water or water and electrolyte pass through membrane 63 into space 69 in a direction perpendicular to the flow in space 65 .

Substance 15 released from the space 65 and entering the outlet branch pipe
is highly concentrated and contains waste products such as urea, uric acid, and creatinine.

Since the retraction filter 60 does not come into contact with blood, there is no need to use non-thrombogenic materials, and a suitable material for membrane 63 is cellulose acetate.

These thin films are made by dissolving cellulose acetate in acetone, typically a formamide solvent.

This solution is shaped into a cloth, evaporated for a short time, and then poured into cold water to remove acetic acid and formamide and gel as cellulose acetate.

Next, this thin film is heat treated at 70 to 90°C.

A high pressure is applied to the surface of the membrane 63 facing the space 65.

The basic embodiment of the invention requires a minimum pressure of 600 psi.

The total area of these surfaces may be varied, and it is appropriate that the total area of the thin film that actually acts is about 1000 to 3000 crfI2.

The finished films can be of various dimensions, but the length is 15
It is appropriate that the width of CrrL1 is 5crfL1 and the thickness of approximately ICrrL or less.

The entire retraction filter consists of approximately 22 sets of membranes 63.

Space 65 should be approximately 50-300 microns.

FIG. 3B shows a modified retracting filter design 60' of the present invention.

The membrane tube 63' shown is made by filling a tube of appropriate diameter with a solution of cellulose acetate dissolved in acetone and blowing it with a Bragg blast with a pressurized air column.

The entry of the air column blows the cellulose acetate solution onto the wall of the support tube to form a thin cylindrical tube concentric with the tube wall.

Acetone is removed from the mixture using air followed by a water column to solidify the acetate-complexed cellulose as a solid hollow tube.

In this way, tubes with a diameter of less than 500 microns can be easily produced.

The preferred diameter is approximately 250 microns.

The tubes in the figures are greatly enlarged for illustrative purposes.

The tube itself has low inherent mechanical strength and is supported by a porous support tube (not shown) made of hardened stainless steel, silver, Incornell, tantalum, or the like.

Suitable non-metallic materials for making the support tube are glass fibers hardened with epoxy or polyester resin, woven nylon or glass string hardened with resin or filler, ceramics and glass ware.

The tube must have an outer diameter of approximately 500 microns, be finely porous, withstand high internal pressures, be corrosion resistant, release no toxic substances, and be suitable for insertion into body fluids.

Any material may be used as long as it satisfies these conditions; the above list of materials is not absolute.

The tubular thin film group should have a length of 15Cr, which should be similar to the flat plate group in terms of capacity.
rL1 diameter 1.7cm, total weight 100-150t? are actually made.

The retraction filters 60, 60' are designed to reduce polarizability to a negligible degree.

4.5 and 6.7 show details of suitable embodiments of the new high pressure micropump and metering device group 81 of the present invention.

The metering device group mounted on the fixed base 100 includes a shaft 86 common to the micropump and the metering part and a suitable electric motor 8 for driving the shaft 86 via a sleeve bearing 83.
2, and the rotational speed of the shaft is suitably about 3,600 revolutions/minute.

The shaft 86 is supported by two shaft suspensions each having a ball bearing 87 and 87.1 and a retaining ring 84 and 84.1.

Rotation of shaft 86 is converted from rotary to reciprocating motion by a ball bearing cam arrangement.

As shown in FIG. 5, an example of the eccentric cam for driving is 89, and a ball bearing for the cam device is 88.

The reciprocating motion from the driving eccentric cam 89 is transmitted to a piston 99 in a pump chamber 90 (FIG. 5), and the diaphragm 91 of the sign stick pump is alternately compressed and released to develop a pumping motion.

The return spring 92 is provided to limit the return of the piston and return the piston 99 to its original position, thereby adjusting the suction force generated within the pump chamber 90.

In this way, the mold corrosion on the blow side of the pump is adjusted.

Double check valve 96°96.1, 96.6 and 96.
7 adjusts the flow during operation to prevent backflow.

The metering portion of the metering device group 81 includes a pump 9 as shown in FIG.
4 and 94.1, and are connected by a metering adjustment arm 95.

The metering pump 94.1, like the pump 90, is driven by a ball bearing cam arrangement 88.2 and a return spring 93, and the pump 94 is driven by the drive cam 88.2 through an adjusting arm 95.

The arm 95 is supported by a base support 100 and is supported by a spring 1.
01 is brought into contact with the cam 88.2.

Pump 94 works in concentrated electrolyte solution and is adjustable by its displacement.

The displacement of the pump 94.1 can be varied by a factor of approximately 1/40.

Since the two metering pumps are mechanically connected to each other, a fixed displacement ratio is maintained even when the capacity becomes smaller due to a drop in suction pressure as described above.

Also, as mentioned above, the pump group has a pressure of about 600 to 700 ps.
i, and the suction pressure is limited to -5 psi.

Pump 90 of the pump group withdraws the used dialysate 16 from the hemodialyzer 12 in portion 21m7, and the patient's heart provides the pressure to pump the blood to the dialyzer and back to the venous cannula 18.

The micropump 90 also pumps used dialysate at a rate of about 21 mm per minute.
m/m into the retraction filter.

The metering pump system is designed to process a total volume of 21 TrLl per minute.

Therefore, it is possible to constantly suck up the effluent from the retraction offshore overpass and operate under limited suction conditions.

This provides stable operation of the high-pressure micropump metering device.

FIG. 7 clearly shows the relationship between the pump chamber 90, the input/output double check valves 96 and 96.7, and the ball bearing cam arrangement.

Spring 92 returns piston 99 to its highest position;
If the suction pressure limit exceeds, it is prevented from following the cam, and by this means, mold corrosion is prevented.

The diaphragm 91 connects the base of the pump chamber 90 and the piston 9.
9, but can move freely on its sides.

Mode check valves 96 and 96.7 control the direction of movement of the pumped liquid so that the inlet and outlet are each separately connected to the pump chamber 90 through a common channel 108.
connected to.

Since the pump is operated continuously, a high-efficiency pump with a long life is appropriate so that it can be operated without any accidents for more than one year.

As mentioned above, a pressure of 500-700 psi is a suitable maximum pressure to overcome osmotic back pressure.

Further, a pressure of 500 to 700 psi is optimal from the viewpoint of the lifetime of the thin film.

A capacity of 21 rrLl per minute is provided with a view to purifying 301 dialysates per day.

The daily value of 301 was determined from construction technology and design standpoints as well as appropriate rates of blood purification.

Physiologically, a daily blood volume of 20-901 is a suitable value, and as a standard, 8-24? The goal is to remove urea.

Generally, hemodialyzers allow the diffusion of solutes with a molecular weight of 5,000 or less, but they can also be easily manufactured to allow solutes with a high molecular weight of 30,000 to pass through.

The blood channels in the hemodialyzer should maintain a high flow rate while retaining plasma plates and red blood cells with low polarization.

One of the features of the present invention is that the amount of replenishment solution is small.

That is, about 200 to 300 ml of waste is added to the dialysate every day to replenish what was removed by the retraction filter. During dialysis, the electrolyte concentration in the dialysate is maintained at the same level as in the blood so that necessary solutes are not removed from the blood.

Replenishment solution is approximately 200-400mLjI/rfL/! , so that no more than 11 small reservoirs can be
Only two fills are required.

In other words, it is sufficient to introduce two solids of about 1301 per day per 300 d of solution.

The replenishment solution is simply added to the dialysate and never mixed with the patient's blood, thus eliminating the possibility of blood contamination from the replenishment solution.

Other embodiments of the invention are shown in Figures 1B, IC and 1D.

In the embodiment shown in FIG. 1B, to reduce the load on the retraction filter 60, the electrolyte in the used dialysate 16 is first removed and the low molecular weight solutes are then discarded as waste.

In FIG. 1B, the used dialysate 16 is not sent directly to the retraction lacrimator 60, but first passes through a low power electrodialyzer with membrane 2. In FIG.

A charge gradient within the electrodialyzer separates the electrolyte from the non-electrolytic solute across the membrane.

It is returned to the electrolytic dialyzer as an electrolytic dialysate mainly consisting of an aqueous solution 21 of a non-electrolytic solute.

The P fluid side of the lacrimal apparatus retracts due to the action of electrodialysis treatment 6,9
The difference in electrolyte concentration between the retained solute side 6 and 5 is extremely reduced.

The waste 25 stored in the toilet bowl in this embodiment is therefore more highly concentrated in terms of waste production and electrolytes than the waste from the retraction filter in the basic example described above.

The osmotic pressure of the retraction filter, ie the extrusion force decreases from 6°9 to 6,5 for water and from 6,5 to 6°9 for solute.

As a result, pump pressure and energy consumed are reduced and less water is lost to waste 25.

The power saved in pumping is used by the electrodialyzer to provide a charge gradient.

In Figure 1A shown as a basic example, 500 to 700 psi
A pressure in the range of is required to force the water through the retraction strainer.

This is due in part to the fact that the cellulose acetate film is so strong that it prevents the passage of small solutes, thus requiring a pressure drop to force the water out.

However, the main role is that the water has to overcome a high osmotic back pressure before passing from the concentrate side 61.5 to the fresh water side 6,9.

For example, for concentration 6, the osmotic backpressure on the concentration side 6,5 is about 550 psi.

The amount of retracted lachrymal fluid 17 obtained in this embodiment can be increased without having to overcome the increased osmotic pressure on the retracted lachrymal lacrimal side 6°9.

In this condition, the unfiltered waste or urine 25 is concentrated such that the waste per day is 21.

High urine production in the basic case is not a serious disadvantage if the patient can easily replace 51 fluids per day by swallowing an average of less than 1 cup per hour.

FIG. 1C shows a system diagram of another embodiment of the present invention.

In this example, the advantages of the example of FIG. 1B are retained, with the electrolyte removed from the spent dialysate being utilized to reconstitute the purified dialysate.

In this example, the electrolytic dialysate, which is mainly an aqueous solution 21 of non-electrolytic solutes, passes through the retraction filter 60, and the regressed filtrate 17 is treated as a substance that has not been filtered through the retraction filter and is preferably electrolyzed as an electrolytic dialysate. Returned for dialysis treatment action.

After passing through the dialyzer, instead of being sent to the toilet bowl as in the previous case, the electrolytes in the purified retracted lachrymal fluid 17 flow to a metering pump 93 to mix with replacement electrolytes to reconstitute the dialysate. The blood is recirculated to the hemodialyzer 12 for further treatment.

The waste 15 that has not been filtered through the regression filter is mainly urea,
Creatinine, uric acid, sugar and others.

The waste effluent 25 from the electrolytic dialyzer does not contain toxic substances such as urea and can therefore be reused.

Similar to the embodiment of FIG. 1B, the p-liquid side 6, 9 of the retraction filter
The osmolality from the concentrate side 6,5 is reduced by removing the electrolyte in the electrodialyzer, and the rate of urine production returns to about 21 per day.

In this example, since the removed electrolyte is utilized, the amount of replenishment solution may be small.

One necessary function of the natural kidneys is to remove small amounts of potassium from the blood.

Therefore, it is not possible to save and use the electrolysis wages.

Also, because it is difficult to separate sodium and potassium ions, if a small amount of potassium is passed into the urine, a similar amount of sodium ions must also be sent.

It is therefore a further feature of this embodiment to provide means for performing the electrolyte conditioning function by removing a portion of the potassium ions.

The amount of replenishment solution required is determined by the balance with potassium.

It is possible to reduce the amount of electrolyte to about V2.

FIG. 1D shows a system diagram of another embodiment of the invention.

In this example, the filtration surface of the regressive filter is a so-called modic membrane, consisting of a patchwork of small pieces of cationic and anionic membranes, allowing ions from both poles to pass through under a concentration gradient. .

The lateral surface currents at the boundary between the two pieces prevent a phenomenon known as electrical polarization.

Similar to the retraction filter of the present invention, in the advanced filtration device the solute concentration on the p-number 6,9 is much lower than on the retained water side 6,5, thereby providing a substantial concentration gradient in the membrane.

In the example of FIG. 1D, the retracted P solution 17 contains electrolytes and pure water, while the unfiltered substances include urea, creatinine,
Contains uric acid and others.

It will be easy to see that this embodiment is very similar to a natural kidney.

As a result, the required amount of make-up electrolyte is greatly reduced, similar to the example of FIG. 1C.

The complete retraction filter consists of a series of mosaic membranes consisting of cellulose acetate membranes to deliver a conditioned electrolyte to the retraction filter.

The scope of the invention also includes the fabrication of a disembodied artificial kidney that performs hemodialysis and functions in the manner described above.

It is also within the scope of the present invention that the type of power source can be varied.

Any type of power source, mobile or stationary, may be used in the present invention.

Many other variations of the invention are also possible.

Various arrangements of motors and pumps may be made without departing from the spirit and scope of the invention.

It is also possible to make various modifications to the thin membranes used in hemodialyzers and retraction lachrymal devices.

For example, a variant of the invention may be similar to a retraction filter obstruction.
It also includes safety devices to prevent punctures, leaks, and ruptures in the fluid transport lines of the device system.

Also within the scope of the present invention are various electrical circuit breakers that operate automatically in response to significant changes in flow, concentration, etc. at various points in the system.

For example, a sensing interrupter can be installed between the metering pump and the hemodialyzer to measure the ionic conductivity of the reconstituted dialysate.

If the metering pump or retraction filter malfunctions and the dialysate is not adjusted to the appropriate electrolyte concentration determined by the ionic conductivity of the material, an automatic circuit breaker for the motor will operate and shut down the kidneys. and prevent these electrolytes from being removed from the blood.

Furthermore, a sensing interrupter similar to the present device can be installed to measure the ionic conductivity of the waste in the toilet bowl.

If more material than determined by ionic conductivity passes through the retraction filter as waste, an automatic circuit breaker shuts down the motor and alerts you to a malfunction and the need for administrative checks.

Various other design features may be included.

Particularly for the small and compact artificial kidney of the present invention, a device for attachment to the body is employed.

For example, toilet bowls and electrolyte replenishment tubes can be worn on various parts of the body, such as the legs and kidneys, without any hindrance.

Other components of the device may be incorporated into a kimono or otherwise and attached to the waist circumference.

Other variations of the invention include loading glucose or other non-electrolytes into a replenishment reservoir connected to the venous return path.

In this way, the patient does not need to ingest these substances explicitly.

It is also within the scope of this invention to use anti-coagulants, such as heparin or coumarin, in artificial kidney devices to reverse clotting and increase safety.

Yet another embodiment of the invention is shown in FIG.

Peritoneal fluid 202 is withdrawn by a conventional ureter tube 204 (silicon rubber is suitable) inserted into the peritoneum or abdominal cavity and pumped into the inlet side 208 of the retraction irrigation device 210 by a high pressure pump 206.

A retraction filtration device or retraction filter 210 includes a filtration element 212
A thin membrane with permeable membrane-like properties is placed in a suitable container.

On the same inlet side 208 of the filtration element 212 are both an inlet 214 for condensate and an outlet 216 for toxic metabolites;
On the opposite side there is an outlet 218 for the purified P liquid.

The retraction filter 210 consists of a number of thin film layers separated by flow spaces and is typically in the form of an exchanger assembled by plates and frames.

The membrane layer may also consist of a tubular element 63' in a cylindrical bundle with a header as shown in FIG. 3B.

As for the retraction filter suitable for use in this embodiment, there are many alternative devices which, as already mentioned, have retraction filtration characteristics for purifying the dialysate of the external dialyzer.

The peritoneal fluid is filtered under pressure at a rate of 5 to 50 m/min.
0, passes through the retraction filter in parallel motion to the filter element 212, and is delivered out the outlet 216 as a concentrated solution of low molecular weight solutes or urea, creatinine, uric acid metabolites, and electrolytes.

The pressure is maintained in the range of 400-600 psi, with a pressure differential provided across the membrane 212 within the overload device 210 by a pressure regulating valve 220 in the pump 206 and waste removal passageway 222.

Regulating valve 220 constantly sends condensate through retraction filter 210 and waste 222 to toilet bowl 224 .

In a normal peritoneal dialysis process, water is also removed from within the peritoneal fluid.

This is complemented by delivering a solution containing sorbitol or sugar such as glucose into the peritoneal cavity, creating an osmotic pressure difference between the body and the solution and creating a flow of water through the peritoneal membrane to the solution that makes up the peritoneal fluid.

Generally, metabolites and electrolytes do not pass through the membrane 212 and are rejected, and only pure water passes through the membrane to the low pressure side 226 of the retracted filter.

Therefore, in the retraction filter, since a large amount of condensate passes through the overflow element 212, the peritoneal fluid is concentrated several times, and the amount of waste 222 can be treated proportionally, eliminating the need for frequent removal and emptying of the toilet bowl. .

The condensate or P solution is reconstituted by pumping and adding concentrated solutions of electrolytes and sugars such as dextrose and sorbitol from reservoir 230 using metering pump 232 .

The reconstitution solution may be added to the p-fluid exiting the retraction filter 210 or, as shown in FIG.
will be added.

The direction of this flow is therefore opposite to the flow of peritoneal fluid.

With this arrangement, the osmotic pressure of the solution is reduced by the thin membrane 21 of the retraction filter.
Used to assist the flow of water through 2.

The reconstituted water 228 is returned to the peritoneum through a suitable ureter for further peritoneal dialysis to remove harmful substances.

High pressure pump 206 and metering pump 232 are cam driven by suitable electric motors which are in turn powered by portable rechargeable batteries to provide a convenient portable device.

Conventional pumps and metering devices may be used and have been detailed above.

This embodiment thus provides a compact, portable artificial kidney that is ideal for use with regenerators, retraction lacrimators, and peritoneal dialysis machines that use reconstituted peritoneal fluid, and that liquid and has a single recirculation loop.

Of course, it is possible to change the power source required for pump operation within the scope of the present invention, and any type of power source and whether it is mobile or stationary can be used.

Many other variations are possible and include safeguards to prevent punctures, leaks, and ruptures in the liquid transport line as well as obstructions in the retracting filter.

Sensing devices are also needed to sense the concentration of toxic substances in the recirculating peritoneal fluid and the accumulation of waste in the toilet bowl, as well as automatic shut-off devices and security devices to alert the patient of malfunctions and the need for servicing the device.

The present invention is not limited to the details described above and can be modified in various ways without departing from the spirit of the invention or its main features.

[Brief explanation of drawings]

The accompanying drawings, which are a part of the specification, illustrate several embodiments of the invention and provide a detailed description of the invention. Figures 1A, IB, IC and 1D FIGA, IB. 1C
and 1D are system explanatory diagrams showing one specific example of the present invention;
Diagram A is a basic example, and Diagrams 1B, IC, and ID are modifications of the basic example. FIG. 2 FIG. 2 is a fragmentary perspective view showing the detailed structure of the dialyzer;
Figure 3 AFIG3A is a top view of a part of the retraction p-transformer, Figure 3B
Figure FIC3B is an exploded parts arrangement diagram showing a modification of the retracting lachrymal organ. FIG. 4 FIG. 4 is a plan view of the electric motor, high-pressure pump, and metering pump; FIG. 5 FIG. 5 is a sectional view taken along plane 5-5 of FIG. 4; FIG. Figure 7F
IG7 is an enlarged sectional view taken along the plane 7-7 of FIG. 4, FIG. 8 FIG. 8 is an exploded parts arrangement diagram of one example of the artificial kidney according to the present invention, and FIG. 9 FIG. 9 is an example of using only peritoneal fluid. It is a system explanatory diagram. 10... Arterial cannula, 12... Hemodialyzer, 1
3... Solution, 14... Dialysate, 15... Concentrated waste (stream), 16... Used dialysate, 17... Retraction P
Liquid, 18... Intravenous cannula, 21... Inflow tube (flow), 25... Waste, 41... Cylindrical spacer, 43
... Thin membrane, 45... Arterial blood channel, 53...
Dialysate channel, 60... Regression filter, 60'...
・Regression filter, 6,5...Concentration side of filter, 6.7・
... Moisture side of the filter, 63... Lacrimal surface, 63'... Cylindrical thin film element, 65... Space, 67... Perforated plate,
69... Space, 81... High pressure pump and metering device group,
82...Electric motor, 83...Sleeve bearing, 84...
- Retaining ring, 84.1... Retaining ring, 86...
Shaft, 87... Ball bearing, 87.1... Ball bearing, 88.
88.2... Ball bearing cam device, 89... Drive eccentric cam, 90... Pump chamber, 91... Diaphragm, 9
2...Spring, 93...Measuring device, 94, 9
4.1... Metering pump 95... Metering adjustment arm, 9
6...Check valve, 96.1, 96.7, 96.
8...Check valve, 99...Piston, ioo...
・Fixed base, 101...Spring, 108...
Common channel, 151... Toilet bowl, 153... Pressure regulating valve, 182... Power supply, 193... Replenishment storage tank,
195... Electrolyte solution, 196... Outlet, 200...
... Peritoneal fluid, 204 ... Urine tube, 206 ... High pressure pump, 210 ... Retraction filtration device (filter), 212 ...
...filtration element (thin film), 214...filter inlet, 2
16... Filter outlet, 218... Purification F liquid outlet, 219... Reconstitution solution addition point, 220... Pressure adjustment valve, 222... Waste and removal passage, 224...・
Toilet bowl, 226... filter low pressure side, 22B... reconstituted water, 232... metering pump, 230... storage tank.

Claims (1)

[Scope of Claims] 1. A dialysis device including a selective thin membrane for removing toxic solutes from body fluids, a device for conveying body fluids to one side of the membrane of the dialysis device, creating a concentration gradient of solutes and transferring dialysate from the body fluids through the membrane. a device for transporting the aqueous dialysate free of toxic solutes to the other side of the membrane to allow diffusion into the membrane; housed in a suitable container having inflow means, purified filtrate outflow means and toxic solute outflow means; A dialysate purification hyperfiltration device for removing toxic solutes from a dialysate comprising a plurality of membrane groups having supported hyperfiltration properties, for removing used dialysate containing toxic substances from said dialyzer. a pump device for controlling the osmotic back pressure of the ultrafiltration device for dialysate purification, which transports the dialysate to the inlet means of the ultrafiltration device for purifying dialysate; and a device for returning the purified dialysate from the P liquid flow means to the dialyzer; A device for removing toxic substances from body fluids, comprising: