EP-4735072-A1 - BLOOD DIALYZING APPARATUS AND METHOD

EP4735072A1EP 4735072 A1EP4735072 A1EP 4735072A1EP-4735072-A1

Abstract

Provided is a blood dialyzing apparatus having multiple fluid chambers each having an internal space to accommodate dialysate, a chamber pressurizing member compressing or expanding the internal spaces of the chambers, and a chamber pressurizing member driver driving the chamber pressurizing member. The chambers are each connected with an inflow tube through which a fluid is provided to the chamber and an outflow tube through which a fluid of the chamber is discharged therefrom. Multiple flow control valves are also provided to regulate flow passages through the tubes.

Inventors

LEE, JAKE KYUNGSOO

Assignees

ExoRenal Inc.

Dates

Publication Date: 20260506
Application Date: 20240701

Claims (19)

WHAT IS CLAIMED IS: 1. A blood dialyzing apparatus comprising: a blood dialyzing filter; a blood flowing unit allowing blood to flow through the blood dialyzing filter, and a dialysate flowing unit allowing dialysate to be prepared and transferred through the blood dialyzing filter, the dialysate flowing unit including a flow control unit for regulating the dialysate flow through the blood dialyzing filter, wherein the flow control unit comprising: first and second chambers each having an internal space and connected with an inflow tube and an outflow tube, wherein a fluid is provided to the chamber through the inflow tube and the fluid of the chamber is discharged through the outflow tube; a chamber pressurizing member disposed inside each of the first and second chambers and compressing or expanding the internal space thereof; a chamber pressurizing member driver operating the chamber pressurizing members, and flow control valves installed in the inflow and outflow tubes of the first and second chambers and controlling flow passages therethrough, wherein the outflow tube of the first chamber is connected to the blood dialyzing filter and the inflow tube of the second chamber is connected to the blood dialyzing filter.
2. The blood dialyzing apparatus of claim 1, wherein the outflow tubes of the first and second chambers are connected to the respective chambers at an upper portion of the chambers along a vertical direction.
3. The blood dialyzing apparatus of claim 2, wherein the first chamber is compressed while the second chamber is expanded.
4. The blood dialyzing apparatus of claim 3, wherein the flow control unit further includes a fluid pump transferring dialysate to the first chamber or a second fluid pump.
5. The blood dialyzing apparatus of claim 3, wherein the flow control unit further includes: a first fluid container having an internal space to accommodate the dialysate, a second fluid container having an internal space to store the dialysate, and a load cell measuring a weight of the first fluid container and the second fluid container, wherein the first fluid container is placed upstream of the first chamber, allowing the dialysate of the first fluid container to be supplied to the first chamber, and the second fluid container is placed downstream of the second chamber, thereby allowing the dialysate of the second chamber to flow into the second fluid container, the first and second fluid containers are each connected with an inlet tube and an outlet tube, wherein a fluid is supplied to the container through the inlet tube and the fluid of the chamber is discharged through the outlet tube; the first and second fluid containers are each connected with a vent tube allowing air or dialysate to flow therethrough, flow control valves are installed in the inlet and outlet tubes connected to the first and second fluid containers, and a fluid pump is provided to transfer dialysate to the first fluid container or discharge dialysate from the second fluid container.
6. The blood dialyzing apparatus of claim 5, wherein the load cell further comprises a first load cell measuring a weight of the first fluid container and a second load cell measuring a weight of the second fluid container, wherein the first load cell is placed at the bottom of the first fluid container and the second load cell is positioned at the bottom of the second fluid container.
7. The blood dialyzing apparatus of claim 5, wherein the first and second fluid containers are stacked vertically, and the load cell is placed at the bottom of the stacked fluid containers.
8. The blood dialyzing apparatus of claim 2, wherein the flow control unit further includes: first and second volume chambers each having an internal space, and a volume chamber pressurizing members disposed inside each of the first and second volume chambers to compress and expand the internal spaces thereof, wherein the first volume chamber is connected to a tube connecting the first chamber and the blood dialyzing filter, and the second volume chamber is connected to a tube connecting between the blood dialyzing filter and the second chamber, and a flow control valve is installed in the tube connected to the second volume chamber.
9. The blood dialyzing apparatus of claim 8, wherein the first and second chambers are compressed and expanded simultaneously, and the volume chambers are compressed and expanded simultaneously, wherein when the first and second chambers are compressed, the first and second volume chambers are expanded.
10. The blood dialyzing apparatus of claim 9, wherein the second volume chamber is connected with a second tube through which dialysate of the second volume chamber is discharged when the second volume chamber is compressed, and a second flow control valve is installed in the second tube connected to the second volume chamber.
11. The blood dialyzing apparatus of claim 10, wherein the flow control unit further includes: a first fluid container having an internal space to accommodate the dialysate, a second fluid container having an internal space to store the dialysate, and a load cell measuring a weight of the first fluid container and the second fluid container, wherein the first fluid container is placed upstream of the first chamber, allowing the dialysate of the first fluid container to be supplied to the first chamber, and the second fluid container is placed downstream of the second chamber, thereby allowing the dialysate of the second chamber to flow into the second fluid container, the first and second fluid containers are each connected with an inlet tube and an outlet tube, wherein a fluid is supplied to the container through the inlet tube and the fluid of the chamber is discharged through the outlet tube; the first and second fluid containers are each connected with a vent tube allowing air or dialysate to flow therethrough, flow control valves are installed in the inlet and outlet tubes connected to the first and second fluid containers, and a fluid pump is provided to transfer dialysate to the first fluid container or discharge dialysate from the second fluid container.
12. The blood dialyzing apparatus of claim 11, wherein the load cell further comprises a first load cell measuring a weight of the first fluid container and a second load cell measuring a weight of the second fluid container, wherein the first load cell is placed at the bottom of the first fluid container and the second load cell is positioned at the bottom of the second fluid container.
13. The blood dialyzing apparatus of claim 11, wherein the first and second fluid containers are stacked vertically, and the load cell is placed at the bottom of the stacked fluid containers.
14. A blood dialyzing apparatus comprising: a blood dialyzing filter; a blood flowing unit where blood flows through the blood dialyzing filter, and a dialysate flowing unit where dialysate is prepared and transferred through the blood dialyzing filter, the dialysate flowing unit including a flow control unit for regulating the dialysate flow through the blood dialyzing filter, wherein the flow control unit comprising: a first fluid container having an internal space to accommodate dialysate, a second fluid container having an internal space to store dialysate, and a load cell measuring a weight of the first fluid container and the second fluid container, wherein the first fluid container is placed upstream of the blood dialyzing filter and the second fluid container is placed downstream of the blood dialyzing filter, the first and second fluid containers are each connected with an inlet tube and an outlet tube, allowing dialysate to flow into and flow out of the container, respectively, and a vent tube allowing air or dialysate to flow therethrough, the first and second fluid containers are each provided with a level sensor installed in a container housing and detecting a fluid level therein, and flow control valves are installed in the inlet and outlet tubes connected to each of the first and second fluid containers.
15. The blood dialyzing apparatus of claim 14, wherein the load cell further comprises a first load cell measuring a weight of the first fluid container and a second load cell measuring a weight of the second fluid container, wherein the first load cell is positioned at the bottom of the first fluid container and the second load cell is positioned at the bottom of the second fluid container.
16. The blood dialyzing apparatus of claim 14, wherein the first and second fluid containers are assembled with each other, and the load cell is positioned at the bottom of the assembled fluid containers.
17. The blood dialyzing apparatus of claim 16, wherein the first and second fluid containers are further provided with a protruding body placed inside the container at a fluid level of the level sensor.
18. The blood dialyzing apparatus of claim 16, wherein each of the fluid containers includes two or more level sensors installed inside a container housing, wherein at least one level sensor is placed at a lower portion inside the container housing along a vertical direction and another level sensor is placed at an upper portion inside the container housing, wherein the second fluid container include equal to or greater number of level sensors than the first fluid container.
19. The blood dialyzing apparatus of claim 16, wherein the flow control unit further includes a weight with a known mass to calibrate the load cell.

Description

BLOOD DIALYZING APPARATUS AND METHOD CROSS-REFERENCE TO RELATED APPLICATIONS This application is a continuation-in-part of U.S. Patent Application Serial No.17/082,016 filed on October 28, 2020, which is a continuation-in-part of U.S. Patent Application Serial Nos.16/573,934 filed on September 17, 2019, now patented with Serial No. 11,185,620, and 16/703,757 filed on December 4, 2019, this application is a continuation-in-part of U.S. Patent Application Serial No.17/893,149 filed on August 23, 2022, which is also a continuation-in-part of U.S. Patent Application Serial Nos. 16/703,757 filed on December 4, 2019 and 17/082,016 filed on October 28, 2020, and this application also claims the benefit of priority to U.S. Provisional Patent Application Serial Nos.63/524,627 filed on July 1, 2023, 63/540,107 filed on September 24, 2023, 63/641,391 filed on December 16, 2023, and 63/626,326 filed on January 29, 2024, the entire contents of which are incorporated by reference herein. TECHNICAL FIELD The present invention relates to blood dialyzing apparatus and method, in which a plurality of dialysate chambers is compressed and expanded to allow dialysate to flow through a blood dialyzing filter, thereby making the blood dialyzing apparatus simplified and light-weighted, providing easy operation, reducing cost for the dialyzing treatment, and eventually enabling the dialyzing treatment to be conducted at home. BACKGROUND When there is a kidney dysfunction, water and waste products that have to be discharged out of body accumulate in blood and imbalance of electrolytes in the body occurs. Most commonly performed to improve such a kidney failure symptom, is hemodialysis which is to circulate blood out of body and rid the blood of the accumulated uremic toxin and excess water by a semi-permeable dialysis membrane. Hemodialysis is a method of seeking an electrolyte balance and ridding the body fluid of uremic toxin and excess water, taking advantages of diffusion applied due to the concentration difference and filtration applied due to the pressure difference between blood and dialysate. Hemodialysis is the example of the blood dialyzing treatment in which blood of a patient is circulated extracorporeally to remove toxic substances from or supply beneficial ingredients to the blood. The blood dialyzing treatment is frequently combined with a blood dialyzing filter in which mass transfer between blood (i.e., a physiologic body fluid) and dialysate (i.e., a purified sterile solution). Most commonly used of blood dialyzing filter is the type that is a cylinder-shaped container charged with a bundle of hollow fiber membranes and port-processed at both ends thereof by use of a synthetic resin like polyurethane. It is because the hollow fiber blood dialyzing filter has excellent mass-transfer efficiency resulting from large effective surface area between blood and dialysate compared to the small size as a whole. Conventional blood dialyzing devices require a balancing unit connected to the multiple dialysate tubes, two or more dialysate pumps to transfer dialysate, and a blood pump to transfer blood of a patient. It is also indispensable to disinfect the balancing unit, the dialysate pumps, and the dialysate flowing tubes on a regular basis, rendering the conventional blood dialyzing unit complex in the structure and complicated to use. US Patent No. 4,054,522 discloses a degassing apparatus employing multiple fluid chambers, through which dialysate sequentially flows and therefore, functioning as a dialysate pump. The fluid chambers are pressurized or expanded by the piston pushing a rolling diaphragm. In addition, the diaphragm pump having four diaphragm chambers is used to transfer blood, according to WO 8,601,115, in which the diaphragm chambers are operated by a pneumatic driver. However, despite using multiple fluid chambers, they are neither able to achieve the balancing accuracy nor regulate the net volume removal. Additional separate ultrafiltration pumps or balancing chambers are required. The prior disclosures only focus on transferring the fluid, such as either blood or dialysate, and therefore, they are limited to using the diaphragm type pumps. Unlike the disclosure, the four diaphragm chambers are not able to ensure blood flow rates equal upstream and downstream of the dialyzer due to flow resistances through the arterial blood circuit. In order to solve the aforementioned problems, a novel blood dialyzing apparatus is provided, in which multiple blood chambers are compressed and expanded to transfer blood. The multiple chambers ensure blood flow rates upstream and downstream of the blood dialyzing filter to be regulated independently. Neither separate blood pump nor a separate ultrafiltration pump, nor a separate balancing chamber are required. Therefore, the entire system can be sufficiently miniaturized and light-weighted, and easy to be installed while reducing the cost for blood dialyzing treatment. The