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Title:
PORTABLE, WEARABLE HEMODIALYSIS SYSTEM
Document Type and Number:
WIPO Patent Application WO/2020/130995
Kind Code:
A2
Abstract:
The invention is related to a hemodialysis system that can be carried and which is wearable in order to ensure that patients with kidney failure (1) who are undergoing dialysis treatment do not have to be dependent on the hemodialysis machine. The hemodialysis system comprises an ultra filtering diffusion apparatus (2) which enables to carry out hemodialysis procedures without necessitating high dialysis fluids that are used during hemodialysis.

Inventors:
OGUZ SONAY (TR)
Application Number:
PCT/TR2019/051130
Publication Date:
June 25, 2020
Filing Date:
December 20, 2019
Export Citation:
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Assignee:
CANAKKALE ONSEKIZ MART UNIV REKTORLUGU (TR)
International Classes:
A61M1/14; A61M1/16
Attorney, Agent or Firm:
CANKAYA PATENT MARKA VE DANISMANLIK LIMITED SIRKETI (TR)
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Claims:
CLAIMS

1. The invention is a portable wearable hemodialysis system comprising,

- An artery line (18) which delivers the blood received from the patient (1),

- A hemofilter (11) to which the blood received from the patient (1) is delivered via the artery line (18)

- A vein line (19) from which the blood discharged from the hemofilter (11) is delivered back to the patient (1)

- An ultra filtering diffusion apparatus (2) that aids in accelerating the ultra filtering diffusion apparatus that is connected to the hemofilter (11) by means of the hemofilter ultra filtering diffusion apparatus connector (15); said ultra filtering diffusion apparatus (2) is characterized by comprising the parts of;

- fixed plate (3) located at the bottom section of the ultra filtering diffusion apparatus (2),

- an IV bag I (6) located above the fixed plate (3),

- a mobile plate I (4) located above the IV bag I (6),

- an IV bag II (7) located above the mobile plate I (4),

- a mobile plate II (5) located above the IV bag II (7)

- level control sensor (8) fixed on the mobile plate II (5),

- motor and gear system (9) which is connected to the mobile plate I (4) and the mobile plate II (5) and which moves the mobile plate I (4) and the mobile plate II (5) up and down.

2. A hemodialysis system according to claim 1, characterized by comprising a limit switch I (31) and a limit switch II (32) that are located on the mobile plate I (4).

3. A hemodialysis system according to claim 1 and 2, characterized in that it comprises a filtered air discharger (13) which prevents particles or coagulum to reach the patient ( 1 ) and which enables the air bubbles that may be present or that may occur on the vein line (19) to be discharged. 4. A hemodialysis system according to claim 3, characterized in that it comprises pressure sensors (14) that are positioned on the artery line (18), vein line (19) and hemofilter ultra filtering diffusion apparatus connector

(15).

5. A hemodialysis system according to claim 4, characterized in that it comprises a waste valve (16) which is connected to the ultra filtering diffusion apparatus (2) and which enables to discharge out of the system the waste ultrafiltrates that exit out of the ultra filtering diffusion apparatus (2).

6. A hemodialysis system according to claim 5, characterized by comprising a waste collection bag (17) that is connected to the waste valve (16) into which the liquid discharged from the apparatus is collected, when the waste valve (16) is opened.

7. A hemodialysis system according to claim 6, characterized by comprising a flush valve I (20) and a flush valve II (21) that are located on the artery line of the patient (1).

8. A hemodialysis system according to claim 7, characterized by comprising a filter alarm (28) inside the power circuit control box (23) that is located in the system.

9. A hemodialysis system according to claim 8, characterized by comprising an ultrafiltrate discharge level indicator (27) which enables to adjust the fluid volume that is to be discharged into the waste bag (17) in the 4th stage.

10. A hemodialysis system according to claim 9, characterized by comprising an ultrafiltrate filling upper limit adjustment indicator (26) provided in order to adjust how much liquid is going to be filled into the ultrafiltration diffusion apparatus (2) in the 1st stage.

11. A hemodialysis system according to claim 10, characterized by comprising a logic circuit kit (30) located inside the power circuit control box (23), which can be programmed to change the waste volume and the total volume and to enable shifting through the modes of the four positioned switch (29) in order to distribute motor power by means of the level control sensors (8) and the pressure sensors (15) in order for the hemodialysis steps to be continued smoothly.

Description:
PORTABLE, WEARABLE HEMODIALYSIS SYSTEM

Technical Field

The invention is related to a hemodialysis system that can be carried and which is wearable in order to ensure that patients with kidney failure who are undergoing dialysis treatment do not have to be dependent on the hemodialysis machine.

The invention is particularly related to a hemodialysis system which enables to carry out hemodialysis procedures without necessitating high amounts of dialysis fluids that are used during hemodialysis, by means of the ultra filtering diffusion apparatus it comprises.

Prior Art

Nowadays the hemodialysis process is carried out by large machines and high amounts of fluid usage. Normally, the blood of the patient is tried to be cleaned by means of a filter in a hemodialysis machine using 150-200 litres of city water and concentrated dialysis solution mixtures. This is still the same process carried out in dialysis centres that are being used nowadays. Patients with kidney failure that are dependent on the dialysis machine need to be connected to the machine for 4-6 hours 2-3 times a week.

Patients with chronic kidney failure, have only two options, either peritoneal dialysis or hemodialysis. Peritoneal dialysis is given through the abdomen and due to its disadvantages, hemodialysis is a more commonly used method.

Cleaning the blood from toxic residues and ensuring that the blood is suitable for the human body is carried out by means of a process called hemodialysis when the kidneys in the human body cannot provide this function. In order to perform hemodialysis nowadays, large devices, high volumes of water and time are required.

In the Chinese patent document numbered CN 106075624A of the prior art, a small- flow blood dialysis machine is disclosed. In this document, it is mentioned that a flow control device is provided and that this device comprises bottom and top fixed plates and a mobile plate.

In the United States Patent document numbered US2018250461A1 of the prior art a system for hemodialysis which includes a first dialysis system and a second dialysis system is disclosed. According to this document, the first dialysis system is configured to be worn by the patient, and the second dialysis system is configured to be positioned on support, independent of the patient.

In the United States Patent document numbered US2009095679A1 of the prior art, dialysis systems that have been developed for hemodialysis are disclosed. It is disclosed that the hemodialysis systems in the related document may include a dialysate flow path including a balancing circuit, a mixing circuit, and/or a directing circuit.

In the Chinese patent document numbered CN107469170A of the prior art, a wearable artificial kidney is disclosed. The wearable artificial kidney comprises a hemodialysis assembly and also comprises a wearable device. The hemodialysis assembly is installed on the wearable device. The hemodialysis assembly comprises a blood pump, a dialyzer, a dialysis fluid pump and a dialysis fluid container. The wearable artificial kidney can be carried by a dialysis person so that the hemodialysis of a hemodialysis patient is completed in the daily work and life.

When the systems developed in the art was examined, it was realized that there was an absence in the art and the development of a wearable hemodialysis system which enables to carry out hemodialysis procedures without necessitating the patients to be dependent on hemodialysis machines by means of the ultra filtering diffusion apparatus it comprises, was required.

Aims of the Invention

The aim of the invention is to develop a portable, wearable hemodialysis system which enables to carry out hemodialysis procedures without necessitating the patients to be dependent on hemodialysis machines.

Another aim of the invention is to provide a portable, wearable a hemodialysis system which enables to carry out hemodialysis procedures without necessitating high amounts of dialysis fluids that are used during hemodialysis, by means of the ultra filtering diffusion apparatus it comprises.

Detailed Description of the Invention

The hemodialysis system developed in order to reach the aims of the invention has been shown in the figures.

According to these figures; Figure 1: Is the schematic view of the hemodialysis system subject to the invention.

Figure 2: Is the side view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention.

Figure 3: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the beginning of the 1st stage. Figure 4: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the end of the 1st stage and the beginning of the 2nd stage. Figure 5: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the 2nd stage, when the mobile plate I, is up.

Figure 6: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the 2nd stage, when the mobile plate

I is down.

Figure 7: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the beginning of the 3rd stage.

Figure 8: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the 3rd stage, when the mobile plate

II is moving down.

Figure 9: Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention towards the end of the 3rd stage.

Figure lOJs the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention towards the end of the 3rd stage when the mobile plates are about to close.

Figure ll.Is the view of the ultra filtering diffusion apparatus included in the hemodialysis system subject to the invention at the end of the 3rd stage and at the 4th stage. Figure 12. Is the general view of the hemodialysis system attached on a vest, subject to the invention

Figure 13. Is the inner view of the hemodialysis system attached on a vest, subject to the invention.

Figure 14. Is the view showing the replacement process of the hemofilter when the hemodialysis system subject to the invention is attached on a vest. Figure 15. Is the schematic view of the power control box located on the hemodialysis system subject to the invention.

The parts in the figures have each been numbered and their references have been listed below.

1. Patient

2. Ultra filtering diffusion apparatus

3. Fixed plate

4. Mobile plate I

5. Mobile plate II

6. IV bag I

7. IV bag II

8. Level control sensor

9. Motor and gear system

10. Pump

11. Hemofilter

12. Return valve

13. Filtered air discharger

14. Pressure sensors

15. Hemofilter ultra filtering diffusion apparatus connector

16. Waste valve

17. Waste collection bag

18. Artery line

19. Vein line

20. Flush valve I

21. Flush valve II

22. Batteries

23. Power circuit control box

24. 1. Socket connector

25. 2. Socket connector 26. Upper limit adjustment indicator for ultra filtering filling volume.

27. Ultra filtering discharge level adjustment indicator

28. Filter alarm

29. Four-position switch

30. Logic circuit kit

31. Limit switch I

32. Limit switch II

The invention is a portable wearable hemodialysis system comprising, - An artery line (19) which delivers the blood received from the patient (1),

- A hemofilter (11) to which the blood received from the patient (1) is delivered via the artery line (19)

- A vein line (20) from which the blood discharged from the hemofilter (11) is delivered back to the patient (1)

- An ultra filtering diffusion apparatus (2) that aids in accelerating the ultra filtering diffusion apparatus that is connected to the hemofilter (11) by means of the hemofilter ultra filtering diffusion apparatus connector (15); said ultra filtering diffusion apparatus (2) comprises the parts of;

- fixed plate (3) located at the bottom section of the ultra filtering diffusion apparatus (2),

- an IV bag I (6) located above the fixed plate (3),

- a mobile plate I (4) located above the IV bag I (6),

- an IV bag II (7) located above the mobile plate I (4),

- a mobile plate II (5) located above the IV bag II (7)

- level control sensor (8) fixed on the mobile plate II (5), - motor and gear system (9) which is connected to the mobile plate I (4) and the mobile plate II (5) and which moves the mobile plate I (4) and the mobile plate II (5) up and down.

The movement of the mobile plate I (4) in the system subject to the invention, between the fixed plate (3) and the mobile plate II (5) is controlled by means of the limit switch I (31) and the limit switch II (32) that are located on the mobile plate I (4). When the limit switch I (31) touches the fixed plate II (5) the motor starts to rotate in reverse and the mobile plate I (4) shall start to move down (towards the fixed plate (3)). When the limit switch II (32) touches the fixed plate (3) the motor starts to rotate in reverse and this time the mobile plate I shall start to move up (towards the mobile plate II (5)). The back and forth movement shall be able to be carried out smoothly at the exact desired range.

The system subject to the invention comprises a filtered air discharger (13) which prevents particles or coagulum to reach the patient (1) and which enables the air bubbles that may be present or that may occur on the vein line (19) to be discharged.

The system subject to the invention comprises pressure sensors (14) that are positioned on the artery line (18), vein line (19) and hemofilter ultra filtering diffusion apparatus connector (15).

The system subject to the invention comprises a waste valve (16) which is connected to the ultra filtering diffusion apparatus (2) and which enables to discharge out of the system the waste ultrafiltrates that exit out of the ultra filtering diffusion apparatus (2).

The system subject to the invention comprises a waste collection bag (17) that is connected to the waste valve (16) and into which the liquid discharged from the apparatus is collected when the waste valve (16) is opened. The system subject to the invention comprises a four-position switch (29) which controls the shifts between open, closed, washing and sleep modes of the system.

The system subject to the invention comprises, a logic circuit kit (30) which can be programmed to change the waste volume and the total volume and to control the four positioned switch (29) in order to distribute motor power by means of the level control sensors (8) and the pressure sensors (14) in order for the hemodialysis steps to be continued smoothly.

The batteries (22) in the system of the invention have been connected as parallel in order to allow them to be changed while the system continues to operate. After a battery (22) is placed, another battery (22) can be taken out and it can be charged.

A 1st socket connection (24) is provided which enables to transfer of power from the control box (23) to the parts of the system such as the motor and gear system (9), the pump (10) waste valve (16) etc. Also, a 2nd socket connection (25) has been provided in the system in order to enable the transferring of required power to the pressure sensors (14) and the level sensor (8).

The hemofilter (11) starts to prevent passages through the filter if there is clogging or any breakdowns. Therefore it is accepted that 20 mmHg pressure between the two ends of the hemofilter (11) is normal. The problem arises as this pressure value increases. By means of the filter alarm (28) within the system subject to the invention, the changes in volume within the system are tracked and thereby filter quality is also tracked. When the pressure rises above lOOmmHg the filter alarm (28) rings and a warning to change the filter is given. At the mid-stages such as 20- 60 mmHg, 60-100 mmHg respectively a led light shall turn on. The descriptions of the led light warnings according to different pressure levels have been given below.

1. Led green: Below 20mmHg (filter is in good condition)

2. Led yellow: Between 20-60mmHg (filter is weak) 3. Led brown: Between 60-100 mmHg (filter wasting away)

4. Led red: Above 100 mmHg (filter needs to be changed)

In the system subject to the invention at the 4th stage, the liquid volume that is to be discharged to the waste bag (17) is adjusted by means of an ultrafiltrate discharge level (27). If the patient (1) drinks a lot of water, this adjustment can be increased (75-100-200 mmHg) to any level, in order to increase fluid discharge or due to other reasons, but it should be known that this adjustment value is very important as it may cause the patient (1) to lose excessive amounts of fluid.

In the system according to the invention, an ultrafiltrate filling upper limit adjustment indicator (26) is provided in order to adjust how much liquid is going to be filled into the ultrafiltration diffusion apparatus (2) in the 1st stage. According to personal differences (being underweight, overweight, etc.) an ultrafiltrate filling upper limit adjustment indicator (26) can be adjusted.

In the hemodialysis system of the invention, the patient (1) artery line (18) connection, vein line (19) connection and hemofilter (11) shall be used the same way as in normal hemodialysis and anticoagulation shall be provided. The ultra filtering diffusion apparatus (UDA) (2) used in the system subject to the invention, creates a reverse membrane pressure at the second stage of the process, thereby it starts to deliver back to the patient (1) the volume that has been gained, via the hemofilter (11) This process aims to redeliver high water content fluid to the patient (1) and additionally as the pores in the filter are also cleaned by means of this process, the filter usage life is also enabled to be prolonged. As a result, a fewer number of filters shall be consumed and cost-saving shall be achieved.

In the system that has been developed, the connection shall be provided by using the same vein route as the vein of the patient (1) that is connected to the hemodialysis device. By means of the pump (10) that is placed on the artery line (18) that receives the blood from the patient (1), it is enabled both to provide blood flow from the hemofilter (11) and to increase membrane pressure. Additionally, passage control on the filter return line, namely the vein line (19), is provided in order to increase the hemofilter (11) membrane pressure. Delivering the blood received from the patient (1) to the filter and then back to the patient (1) shall be similar to the prior systems.

Before the blood is delivered to the patient (1), the blood shall be passed through the filtered air discharger (13) right before being delivered to the patient (1). Thereby any coagulum, particles, etc. that may reach the patient (1) is prevented. In addition, the air bubbles that may form in the system shall also be able to be discharged out of the system by means of the filtered air discharger (13).

The section after the hemofilter (11) is designed to provide a completely different process from the prior hemodialysis technique. In this section, diffusion is aimed to be increased by controlling ultrafiltration that forms the basis of hemodialysis by means of the ultra filtering diffusion apparatus (2), which is the main aspect of our invention.

In the ultra filtering diffusion apparatus (2) within the system subject to the invention, a mobile plate I (4), another mobile plate II (5) and one fixed plate (3) has been provided. An IV bag I (6) and another IV bag II (7) that can contain a volume of 500cc each, has been placed between these plates. The system operates in four stages. The stages are completed in order to complete a cycle and following this, a new cycle is continued with the same consecutive stages.

In the 1st stage, ultrafiltrate is established via the hemofilter (11) by creating the highest filter membrane pressure which does not disintegrate blood by means of controls provided by the pump (10) and return valve (12). When an ultrafiltrate is being established, the aim to create high membrane pressure is to ensure that urea and creatinine etc., that are aimed to be discharged, which have higher molecule weight in comparison to water, are passed into the ultrafiltrate in the shortest possible time. At this stage, 500mmHg is tried not to be exceeded by using pressure sensors (14) in order to ensure that especially erythrocytes that are valuable and shaped elements of blood do not disintegrate. The ultrafiltrate fluid that is created by filtering blood via the hemofilter (HF) (11), is delivered to the ultra filtering diffusion apparatus (2) via the ultra filtering diffusion apparatus connection (15) of the hemofilter (11). The 1st stage we have described, shall continue until the desired volume level is reached inside the ultra filtering diffusion apparatus (2). The ultra filtering diffusion apparatus (2) has been designed to have at most 500cc ultrafiltrate volume. When the 1st stage is being continued, the ultrafiltrate shall fill into the IV bag I (6) and IV bag II (7) that are located within the ultra filtering diffusion apparatus (2) and thereby the mobile plate I (4) and the mobile plate II (5) shall be lifted up. As the washing line connection shall only open during the washing process by being controlled by the flush valve I (20), the washing line connection shall remain closed during all cycles, thereby preventing the passage of the ultrafiltrate.

As the level control sensor (8) is adjusted to 500cc, when 500 cc ultrafiltrate fills into the IV bag I (6) and IV bag II (7) the sensor (8) is actuated and the motion of the mobile plate II (5) shall be stopped. Even if the process continues, as the mobile plate II (5) shall remain motionless, the hemofilter (HF) (11) membrane pressure shall be equalized and the filtration process shall be stopped. This limitation has been deemed necessary for both process and patient (1) safety. The reason for this is that, if ultrafiltration is to continue, the high amounts of fluid to be extracted from the patient (1) may alter the hemodynamic balance. By means of the ultra filtering diffusion apparatus (2) within the system that has been developed, the hemodynamic balance is kept under control and levels can be changed according to requirements. After 500cc volume fills into the inner chamber of the ultra filtering diffusion apparatus (2), the level sensor (8) located at the movement region of the mobile plate I (4) shall be actuated and the 1st stage will come to an end. (Figure 4)

At the beginning of the 2nd stage, the return valve (12) located at the HF (11), return section which returns blood to the patient (1), shall completely open and it shall allow the highest amount of blood passage. The HF (11) membrane pressure shall drop, and the volume of blood to pass through shall be increased to maximum level (300ml/min). The mobile plate I (4) of the ultra filtering diffusion apparatus (2), moves up and down between the fixed plate (3) and the mobile plate II (5) via the control of the motor and gear system (9), in order to deliver the ultrafiltrate that has been collected between the IV bag I (6) and IV bag II (7), over the HF (11). By this means diffusion rate shall be increased. (Figure 5)

In the 2nd stage, toxic substances that accumulate inside the ultrafiltrate (UF), that are planned to be discharged out of the body such as urea and creatinine, and particularly the level of potassium is tried to be equalized with the blood level. This equalization process has been planned to be carried out at a predetermined amount of time. This time can change according to the hemofilter (11) type and coefficient used.

After the 2nd stage is completed, the main aim in the 3rd stage is to create reverse membrane pressure from the UF fluid that has been obtained and to deliver this fluid back to the patient (1) via the HF (11). In order for the fluid to be re -delivered to the patient to contain a high amount of water, low membrane pressure is established. In order to ensure this, pump (10) speed is reduced to 50ml/min. The return valve (12) will be continued to be kept in a completely open position. By delivering fluid with high water content obtained from UF fluid to the patient (1), high waste (urea, creatinine, potassium etc.) fluid will remain.

The mobile plate I (4) shall continue to move between the fixed plate (3) and mobile plate II (5), as mentioned in the 2nd stage, and at the same time, the mobile plate II (5) shall start to move towards the fixed plate (3). The pump (10) continues at the speed of 50ml/min and the return valve (12) will be continued to be kept in a completely open position. By this means the membrane pressure of the HF (11) at the patient (1) side shall be reduced. As the mobile plate II (5) moves down, the ultrafiltrate fluid pressure that is trapped inside the closed area, shall increase and it shall exceed the membrane pressure of HF (11) and filtration opposite to the process in the 1st stage shall start; or in other words, fluid shall be delivered back to the patient (1). (Figure 7)

This process shall continue until the ultrafiltrate level is reduced to 50cc. 450cc fluid shall be delivered to the patient (1) and 50cc fluid with high waste concentration shall remain.

This remaining fluid shall be discharged out of the system via the waste valve (16) that opens at the final stage, which is the 4th stage. (Figure 11)

After all of the stages are completed, the cycle shall come to an end, and a new cycle shall begin, from the 1st stage.

When a washing process is to be carried out in the system subject to the invention, the pump (10) is stopped after 500cc ultrafiltrate accumulation, the flush valve I (20) and the flush valve II (21) are opened; following this first of all 50cc is delivered from the ultrafiltrate that has accumulated, from the patient arrival line and the catheter and thereby the blood arrival line (artery line (18)) is cleaned from blood. Following this, the flush valve I (20) is closed and the patient (1) passage line is closed, the flush valve II (21) is at the open position, its passage towards the pump (10) shall remain open, the pump (10) is then operated at a speed of 200 cc/min, and the pump empties the inner volume of the ultra filtering diffusion apparatus (2), thereby cleaning the hemofilter (11) and the patient (1) delivery line (vein line (19)) from blood. At the end of this procedure, the system is shut off, and the connection of the patient (1) with the system shall be cut off. This self-cleaning feature has provided additional attachable and detachable features to our invention and these features are very important for patient comfort (1).

Additionally, at the 3rd stage of each cycle, while an ultrafiltrate fluid is delivered back to the patient (1), the filter pores are cleaned and the amount of coagulation is reduced by means of removing blood from the lines, and it is enabled for the filter to be operated with high quality and to have a prolonged usage life.

By means of the above-disclosed stages, high waste concentration fluid is obtained from the patient (1) and said waste concentration is discharged out of the system. Although the amounts may change according to the volume balance of the patient (1) and special conditions, normally a cycle needs the last 10 minutes, and the amount of 300cc (6x50cc) waste fluid per hour, should be taken from the patient (1) should be discharged. Due to this reason, the patient (1) shall be allowed to have 300cc (one glass) of water every hour. This water can be tap water, but due to the differences of regional water sources, water having physiologically balanced mineral and electrolytes shall be preferred. While the system enables to discharge of toxic waste out of the body, it may also discharge vital elements for the body such as calcium, magnesium and sodium. Due to this reason, the quality of the water that the patient (1) needs to drink is important. If it is deemed necessary, the physiological balance is maintained with oral supplements. These supplements can be a water-powder mix or in oral tablet form.

The system stages, continue all day consecutively by means of the ultra filtering diffusion apparatus (2) to clean the blood. While during normal hemodialysis, the patient’s (1) water consumption is limited, the system subject to the invention allows the patient (1) to have water without limitations. This situation shall make, patients with kidney failure (1) who have restricted water consumption and who miss drinking water happy. However, it is obligatory to drink a glass of water (300cc) at least every hour. By means of the volume adjustment, excess water can easily be drawn and a higher amount of toxins will be able to be discharged. Due to this reason, the higher water consumption amount according to our designed system shall be beneficial for the patient (1). Indeed, if the patient is suffering from symptoms such as diarrhea and vomiting, it shall be difficult for the patient (1) to consume such high amounts of liquid orally. If such a case is encountered, the patient (1) can continue dialysis with the prior hemodialysis program or the patient (1) shall be given extra fluid to solve this problem.

When the need for the patient (1) to sleep is taken into consideration, as the patient (1) will no longer be performing any oral intake during sleep, the system shall draw 2400cc fluid from the patient (1) after an 8-hour sleep. If this fluid loss is not given back to the patient (1), hemodynamic disorders may be encountered. Due to this reason, before the patient (1) sleeps, the patient shall switch the device into sleep mode and fluid discharge shall be reduced. The waste volume is reduced to lOcc from 50cc. This shows us that after an 8-hour sleep, 480cc ((8x(10x6)) volume fluid shall be extracted from the patient (1). This seems like a tolerable value for the patient (1). If the system is completely stopped, as clogging may occur due to blood clotting reactions, it is preferred for the system to be operated through the night, and the total amount of volume drawn from the patient (1) to be reduced. If the daily required toxin discharge can be reached in the day, by increasing the volume of fluid drawn from the patient (1) and also increasing oral volume taken by the patient (1), the system can be completely disconnected from the patient (1) during sleep, thereby enabling the patient to have a good night's sleep.

The ultra filtering diffusion apparatus (2) delivers the ultrafiltrate fluid to the patient (1) both by the pump (10) and the hemofilter (11) in order to ensure that blood does not remain in the system after the system has been disconnected from the patient (1), and as a result, the entire blood in the system is returned back to the patient (1), thereby preventing loss of blood and preventing blood that may clot and clog the system to remain. The system self cleans itself and is ready to be used the next day. The following amounts are required by an adult: The total volume drawn from the patient (1) is 5280cc, 16 hours x 300cc:4800cc in the day: and 480cc at night, and additionally if insensible (sweating, feces etc) losses are also added +600cc: 5880cc volume needs to be given to the patient (1). A total amount of 5880/16:367.5cc fluid must be taken all day, every hour, until the night, before the patient sleeps. This amount is 1.5 glasses of water and it seems that it can be easily consumed.

These calculations show the amounts of fluid that need to be drawn from and delivered back to the patient (1).

If the blood volume that the apparatus processes is to be calculated the following calculations can be used:

At the 2nd stage where blood flow is the highest, 300cc blood shall pass through the HF (11) per minute, and additionally, 50cc/minute blood passage shall also occur in other stages. (1st stage: 3 min, 2nd stage: 3 min, 3rd stage: 3 min, 4th stage: 1 minute), in a 10 minute cycle (3x50+3x300+3x50+1x50) 1250cc blood shall pass through the hemofilter (11). (In one hour 1250x6: 7500cc.) A total of 7500x24: 180000cc, or in other words 180 liters of blood passes through the apparatus and is processed in one day. If the total blood volume in this body is accepted to be 51t, all of the blood in the body shall be passed through the hemofilter (11) 36 times a day. 72000cc ultrafiltrate is taken from the patient (1) and 66720cc high water content ultrafiltrate fluid is returned back to the patient (1). In total, 5280cc waste concentration fluid shall be discharged from the system, and drawn out from the patient (1) (16x6x50cc: 4800cc 8x6xl0cc: 480cc total of, 5280cc). Water having the balanced electrolytes as much as the fluid that is extracted is given to the patient (1) to be consumed.

By means of the ultra filtering diffusion apparatus (UDA) (2) within the developed system, the blood cleaning calculations of the apparatus shall be as mentioned above in accordance with each cycle that is completed every 10 minutes. According to these calculations if it is assumed that an average of 12gr urea is created in the human body weighing 80kg, in each cycle 125 mg of urea is extracted from the blood of the patient (1) and is delivered to the system. However, in the 3rd stage, an amount of urea shall be delivered back to the patient (1) although this is not desired, during the delivery of ultrafiltrates having high water content to the patient (1) via the reverse membrane pressure. If it is assumed that this gained urea shall be around 25%, 75% of 125 mg urea, which is 93.75 mg shall be removed from the blood in each cycle. As the 1st cycle lasts 10 minutes, according to calculations 6x24x93.75 mg: 13500 mg, in other words, 13.5 gr urea will be discharged from the body. This shows that we can discharge more urea (13.5 gr) than the amount created by the body in one day (12 gr) by means of the apparatus we have developed.

These calculations have been made in order to illustrate that the system that has been developed according to the invention, which comprises the ultra filtering diffusion apparatus (UDA) (2) can be effective. Taking into account personal differences, it can be seen that higher amounts of blood can be cleaned directly proportional to the increase of oral intake of the patient (1). Due to the apparatus being easily attached and detached, it is enabled to be used every other day.

The main mechanical plate motion is provided by means of the motor and gear system (9) that is required for the system to operate, wherein the perfusion of the pump (10) and the hemofilter (11) is provided, additionally in order to enable controlling of the passages within the system, the usage of electrical power control systems (24) have been considered. Electric power shall be generated by means of standard replaceable batteries (22). By means of these features we have described, our invention provides great comfort for patients with kidney failure (1), by allowing them to undergo hemodialysis without having to lie down, by enabling them to use the system on their own, and by said system functioning as an artificial kidney, as it can be worn by the patient

(1).

The ultra filtering diffusion apparatus (2) within the system subject to the invention, eliminated the need for additional amounts of fluid for the hemodialysis process and the requirement for a large dialysis machine for controlling such fluids. As the system has a size that is wearable by the patient (1), the patient can use the system to filter his/her blood while going about his daily life. As a result loss of labour shall be highly reduced. The risk of infections from other people shall also be reduced as the system will only be used by a single patient (1). The psycho-social conditions of the patient are also expected to be improved due to the above mentioned positive effects.