Dialysis machine and corresponding system for blood treatment - Patents.com

Abstract

Disclosed herein is a dialyzer (1) for blood treatment, comprising a housing (11) defining a cavity with a first cavity region (111) and a second cavity region (112) communicating with each other by a passage (113), a plurality of hollow fiber membranes (12) extending from the first cavity region (111) to the second cavity region (112) via the passage (113), a flow restricting structure (13) located in the area of ​​the passage (113) so as to restrict the flow of a medical fluid, e.g., dialysate, between the first cavity region (111) and the second cavity region (112), a first port (14) and a second port (15), each in fluid communication with the first cavity region (111), and a third port (16) and a fourth port (17), each in fluid communication with the second cavity region (112). Also disclosed is a corresponding system for blood treatment, which includes the above-mentioned dialyzer (1), a blood line, and a medical fluid line, the blood line and the medical fluid line being fluidly connected to the dialyzer (1). According to some exemplary embodiments of the present disclosure, the dialyzer has a simplified structure and low cost, and can achieve better control to accommodate various blood treatment modes.

Description

[Technical field]

[0001] The present disclosure relates to a dialyzer for blood treatment and a corresponding system for blood treatment. [Background technology]

[0002] Dialysis treatment is a therapy to remove toxic substances and metabolic products normally removed by the kidneys and to assist in regulating fluid and electrolyte balance.

[0003] Dialysis treatment can be performed by various types of dialysis therapy, such as hemodialysis (HD) and peritoneal dialysis (PD). Hemodialysis is typically performed by using a hemodialysis machine.

[0004] Standard hemodialysis (HD) generally uses diffusion to remove waste products from a patient's blood. Diffusion can occur due to a diffusion gradient that occurs in a semi-permeable dialyzer between the blood and the dialysate. Additionally, hemofiltration (HF) is an alternative renal replacement therapy that relies on convective transport of toxins from the patient's blood. This therapy is achieved by directly or indirectly adding a replacement or substitution fluid to the extracorporeal circuit during the treatment. That replacement fluid and fluid accumulated in the patient between dialysis sessions are ultrafiltered over the course of the HF treatment, thereby providing a convective transport mechanism that is particularly beneficial for removing middle and large molecules.

[0005] Hemodiafiltration (HDF) is a treatment mode that combines convective and diffusive clearance and may therefore represent the gold standard in the field of renal replacement by dialysis. HDF, like standard hemodialysis, uses dialysate flowing through a dialyzer, e.g., a high-flux dialyzer, to provide diffusive clearance. In addition, a replacement fluid, which may also be dialysate, is provided directly or indirectly to the extracorporeal circuit to provide convective clearance.

[0006] Importantly, dialyzers may need to be further improved to simplify the structure and reduce the cost, especially for HDF, and in particular to provide improved dialyzers that are more applicable to different blood treatment modes. Summary of the Invention

[0007] In view of the problems existing in the prior art, it is an object of the present disclosure to provide an improved dialyzer for blood treatment and an improved system for blood treatment.

[0008] To achieve this object, according to a first aspect, a dialyzer for blood treatment is provided, comprising: a housing defining a cavity with a first cavity region and a second cavity region communicating with each other by a pass-through passage; a plurality of hollow fiber membranes extending from the first cavity region to the second cavity region via the passage; a flow-restricting structure located in the area of ​​the passage so as to restrict the flow of a medical fluid, e.g., dialysate, between the first cavity region and the second cavity region; a first port and a second port each in fluid communication with the first cavity region; and a third port and a fourth port each in fluid communication with the second cavity region.

[0009] According to optional embodiments of the present disclosure, the passageway is configured as a constriction region defined at least in part by a flow-restricting structure, and / or the dialyzer is configured to have no potting in the area of ​​the passageway.

[0010] According to optional embodiments of the present disclosure, the flow-restricting structure is configured to be disposed in the housing or integrally formed with the housing, and / or the flow-restricting structure is designed taking into account the expansion characteristics of the hollow fiber membrane during use, and / or the flow-restricting structure is configured to hold the hollow fiber membrane relatively tightly. The term "hold the hollow fiber membrane relatively tightly" means that most of the medical fluid flowing along the first and second cavity regions does not pass through the flow-restricting structure. In further refined embodiments, less than 20%, particularly less than 10%, of the medical fluid passes through the restriction structure.

[0011] According to an optional embodiment of the present disclosure, the flow restricting structure is configured to be formed during or after injection molding of the housing.

[0012] According to optional embodiments of the present disclosure, the flow-restricting structure comprises a protrusion formed during injection molding of the housing, or the flow-restricting structure is at least partially formed by a shrinkable structure that can be shrunk after injection molding of the housing, in particular after installation of the hollow fiber membranes.

[0013] According to optional embodiments of the present disclosure, the protrusion is formed by a curved wall portion of the housing, or the shrinkable structure comprises a heat shrinkable tube.

[0014] According to an optional embodiment of the present disclosure, a heat shrinkable tube forms at least a portion of the housing or is disposed within the housing.

[0015] According to an optional embodiment of the present disclosure, the first port or the second port is fluidly connected with the third port or the fourth port through a fluid flow control device to control the flow of medical fluid between the first port or the second port and the third port or the fourth port.

[0016] According to an optional embodiment of the present disclosure, the housing has a substantially cylindrical configuration, and the first port, the second port, the third port, and the fourth port are axially spaced apart from one another axially and sequentially disposed on the housing, preferably in a row.

[0017] According to an optional embodiment of the present disclosure, the second port and the third port are fluidly connected by a fluid flow control device.

[0018] According to optional embodiments of the present disclosure, the fluid flow control device comprises an on-off valve and / or a flow restrictor.

[0019] According to optional embodiments of the present disclosure, the on-off valve and the flow restriction are connected in parallel between the second port and the third port, and / or the on-off valve is a solenoid valve, and / or the flow restriction is a variable flow restriction, and / or the fluid flow control device further comprises a flow sensor for detecting a flow rate of the medical fluid between the second port and the third port.

[0020] According to an optional embodiment of the present disclosure, the fluid flow control device is integrated as a shunt interlock assembly.

[0021] According to a first aspect, there is provided a system for blood treatment comprising the dialyzer as described above, a blood line and a medical fluid line, the blood line and the medical fluid line being fluidly connected to the dialyzer.

[0022] According to optional embodiments of the present disclosure, the system is configured to perform hemodialysis, hemofiltration, hemodiafiltration, and any combination thereof.

[0023] According to some exemplary embodiments of the present disclosure, the dialyzer has a simplified structure and low cost, and can achieve better control to accommodate various blood treatment modes.

[0024] The present disclosure and its advantages will be further understood by reading the following detailed description of several preferred exemplary embodiments in conjunction with the following drawings, in which: [Brief description of the drawings]

[0025] [Figure 1] FIG. 2 illustrates a schematic cross-sectional view of a dialyzer according to an exemplary embodiment of the present disclosure. [Diagram 2] FIG. 13 shows a schematic cross-sectional view of a dialyzer according to another exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Some exemplary embodiments of the present disclosure will now be described in detail with reference to the drawings in order to better understand the basic concepts and advantages of the present disclosure.

[0027] According to one aspect of the present disclosure, for the first time, a dialyzer for blood treatment is proposed herein, comprising: a housing defining a cavity with a first cavity region and a second cavity region communicating with each other by a passageway; a plurality of hollow fiber membranes extending from the first cavity region to the second cavity region via the passageway; a flow limiting structure located in the area of ​​the passageway so as to limit the flow of a medical fluid, e.g., dialysate, between the first cavity region and the second cavity region; first and second ports in fluid communication with the first cavity region; and third and fourth ports in fluid communication with the second cavity region.

[0028] Here, both the first cavity region and the second cavity region are formed within a common housing.

[0029] FIG. 1 shows a schematic cross-sectional view of a dialyzer 1 according to an exemplary embodiment of the present disclosure.

[0030] As shown in FIG. 1 , the dialyzer 1 includes a substantially cylindrical housing 11 defining a cavity with a first cavity region 111 and a second cavity region 112 that may be in communication with each other by a passage 113, where the first cavity region 111, the second cavity region 112, and the passage 113 may be coaxially arranged, a plurality of hollow fiber membranes 12 extending from the first cavity region 111 to the second cavity region 112 via the passage 113, and a plurality of hollow fiber membranes 12 extending from the second cavity region 112 to the first cavity region 113. 1, a first port 14 as a dialysate (effluent) outlet port, sometimes also called ultrafiltrate port, and a second port 15 as a dialysate inlet port, in fluid communication with the first cavity region 111, a third port 16 as a further dialysate outlet port, and a fourth port 17 as a further dialysate inlet port, in fluid communication with the second cavity region 112. In this case, the dialyzer 1 actually comprises two sub-dialyzers using a common housing 11.

[0031] The dialyzer 1 may have a blood inlet port 19 and a blood outlet port 20. During blood treatment, blood to be treated flows from a patient through an arterial blood line (not shown) into the blood inlet port 19 and flows through the lumen of the hollow fiber membrane 12, and then the treated blood flows out of the blood outlet port 20 and returns to the patient through a venous blood line (not shown), while the dialysate flows in the first cavity region 111 and the second cavity region 112. Since the basic operating principle of the dialyzer 1 during blood treatment is known per se, the following description will focus mainly on some parts related to the present invention in order to achieve corresponding simplification.

[0032] 1, as indicated by the corresponding arrows, the dialysate flows in a countercurrent manner within the housing 11, which can achieve better blood treatment, in particular stronger diffusion through the hollow fiber membrane 12. However, those skilled in the art can understand that this is only an example.

[0033] 1, the hollow fiber membranes 12 are potted only at their ends 121 and 122. This means that each hollow fiber membrane 12 is continuous across the passage 113 without having a potted area in the area of ​​the passage 113.

[0034] According to an exemplary embodiment of the present disclosure, as shown in Figure 1, the passage 113 may be configured as a constriction region defined at least in part by the flow-restricting structure 13. In this constriction region, the hollow fiber membrane 12 is more dense due to the radial compression exerted thereon.

[0035] 1 also shows in its lower part a cross-sectional view of the dialyzer 1 in three corresponding different areas. As can be seen from FIG. 1, the hollow fiber membranes 12 are closer to each other in the area of ​​the passages 113, which means that it is more difficult, or even impossible, for the dialysate to flow through the gap between any two adjacent hollow fiber membranes 12.

[0036] According to an exemplary embodiment of the present disclosure, as shown in FIG. 1, the flow-restricting structure 13 may be configured to be integrally formed with the housing 11. As can be seen from FIG. 1, the flow-restricting structure 13 is formed as a part of the housing 11. In this case, the flow-restricting structure 13 may be formed during injection molding of the housing 11 (which is often made of plastic). As shown in FIG. 1, the flow-restricting structure 13 may include a protrusion formed during injection molding of the housing 11. The protrusion is preferably formed by a curved wall portion of the housing 11. Such a configuration may be easily formed during injection molding of the housing 11.

[0037] Those skilled in the art can appreciate that the flow-restricting structure 13 may be configured to be disposed within the housing 11. Specifically, the flow-restricting structure 13 may be configured as a separate component and then positioned relative to, e.g., attached to, the housing 11 in any suitable manner. For example, the hollow fiber membrane 12 may be mounted within the flow-restricting structure 13, and then they may both be mounted within the housing 11.

[0038] According to an exemplary embodiment of the present disclosure, at least one, and preferably all, of the first port 14, the second port 15, the third port 16, and the fourth port 17 may be integrally molded with the housing 11, which is highly advantageous.

[0039] 1, it may be difficult to install the hollow fiber membrane 12 through the passage 113 due to the limited size of the passage 113. Therefore, it may be advantageous to finally form the flow-restricting structure 13 at least after the hollow fiber membrane 12 is installed in the cavity of the housing 11.

[0040] Thus, according to an exemplary embodiment of the present disclosure, the flow-limiting structure 13 may be at least partially formed by a shrinkable structure that can be shrunk after injection molding of the housing 11, in particular after installation of the hollow fiber membranes 12.

[0041] Preferably, the shrinkable structure may be a heat-shrinkable structure, particularly a heat-shrinkable tube. Shrinking the shrinkable structure can be easily performed due to the heat-shrinkable structure. Of course, the present invention is not limited thereto. For example, the shrinkable structure can be shrunk by light having a specific wavelength.

[0042] According to an exemplary embodiment of the present disclosure, the heat shrinkable tube may form at least a portion, such as an axial segment, of the housing 11 in the area of ​​the passageway 113. That is, at least this segment may be formed by the heat shrinkable material.

[0043] Those skilled in the art will appreciate that the heat shrinkable tube may be first disposed within the housing 11 and then shrunk, particularly after installation of the hollow fiber membranes 12 .

[0044] Generally, the hollow fiber membrane 12 expands when exposed to water, which means, on the one hand, that the flow limiting structure 13 should be designed taking into account the expansion characteristics of the hollow fiber membrane 12 during use in order to avoid excessive compression of the hollow fiber membrane 12 and therefore damage to the hollow fiber membrane 12 or adversely affecting the flow of blood through the lumen of the hollow fiber membrane 12, but on the other hand, that this can be utilized to help restrict the flow of medical fluid from the second cavity region 112 to the first cavity region 111, especially considering that a priming process should be performed before starting the actual blood treatment.

[0045] Therefore, it may be sufficient to configure the flow-restricting structure 13 to hold the hollow fiber membrane 12 relatively tightly, as shown in FIG.

[0046] According to an exemplary embodiment of the present disclosure, the first port 14 or the second port 15 may be connected to the third port 16 or the fourth port 17 through a fluid flow control device 18 to control the flow of medical fluid therebetween. FIG. 1 only illustrates an example in which the second port 15 and the third port 16 are connected by the fluid flow control device 18.

[0047] The dialyzer 1 has a first cavity region 111 and a second cavity region 112, between which a flow restricting structure 13 is located, so that the pressure profile of the dialysate in the first cavity region 111 and the second cavity region 112 can be more flexibly controlled or adjusted to achieve the desired treatment goal, which may vary due to different treatment conditions, especially for different patients. Therefore, the present invention does not intend to exclude any other possibilities, such as connecting the third port 16 with the first port 14, but the specific connection scheme shown in FIG. 1 may be advantageous for most blood treatment modes.

[0048] 1, the first port 14, the second port 15, the third port 16, and the fourth port 17 may be disposed axially spaced apart from one another consecutively, preferably in a row, on the housing 11. Preferably, at least one, and in particular all, of the first port 14, the second port 15, the third port 16, and the fourth port 17 may extend laterally as shown in FIG.

[0049] As can be seen in FIG. 1, the second port 15 and the third port 16 may be disposed on opposite sides of the flow restricting structure 13 and are adjacent to one another.

[0050] According to an exemplary embodiment of the present disclosure, as shown in FIG. 1 , the fluid flow control device 18 may include an on-off valve 181 that can switch on or off the flow of dialysate from the third port 16 toward the second port 15.

[0051] According to an exemplary embodiment of the present disclosure, the on-off valve 181 may be a solenoid valve that can be easily controlled as desired. In this case, the solenoid valve can be flexibly controlled in an on / off cycle.

[0052] However, such a control scheme may cause undesirable momentary stresses across the hollow fiber membranes 12. In this case, it may be advantageous to provide a flow restriction 182 connected in parallel with the on-off valve 181, which is exemplarily shown in FIG. 2, which is the same as FIG. 1 except for a different fluid flow control device 18. The flow restriction 182 can partially bypass some of the dialysate and thus is effective in reducing momentary peak pressures acting on the hollow fiber membranes 12. The use of the flow restriction 182 can also optimize the HDF treatment process.

[0053] Those skilled in the art will appreciate that the flow restriction 182 may be used in place of the on-off valve 181. Using only the flow restriction 182 can also achieve the HDF treatment mode.

[0054] According to an exemplary embodiment of the present disclosure, the flow restriction 182 may be a variable flow restriction. Preferably, the variable flow restriction may be automatically controlled.

[0055] 2, according to an exemplary embodiment of the present disclosure, the fluid flow control device 18 may further include a flow sensor 183 for detecting a flow rate of the dialysate from the third port 16 to the second port 15. Preferably, the flow sensor 183 may be disposed upstream of the on-off valve 181 and the flow restriction 182.

[0056] According to an exemplary embodiment of the present disclosure, the fluid flow control device 18 may be integrated as a shunt interlock assembly, which facilitates assembling the fluid flow control device 18 onto the second port 15 and the third port 16.

[0057] A controller (not shown) may be provided to control the fluid flow control device 18 to accommodate various blood treatment procedures.

[0058] According to another aspect of the present disclosure, there is further proposed a system for blood treatment comprising the above-mentioned dialyzer 1, a blood line (not shown) and a medical fluid line (not shown), the blood line and the medical fluid line being fluidly connected to the dialyzer 1.

[0059] According to exemplary embodiments of the present disclosure, the system may be configured to perform hemodialysis, hemofiltration, hemodiafiltration, and any combination thereof.

[0060] Although specific embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the present disclosure. The appended claims and their equivalents are intended to cover all modifications, substitutions, and alterations that fall within the spirit and scope of the present disclosure.

Claims

1. A dialysis machine for blood treatment, comprising: a housing defining a cavity having a first cavity region and a second cavity region in communication with each other by a through passage; a plurality of hollow fiber membranes extending from the first cavity region to the second cavity region through the passage; a flow restricting structure located in the area of ​​the passageway so as to restrict the flow of medical fluid, e.g., dialysate, between the first cavity region and the second cavity region; a first port and a second port each in fluid communication with the first cavity region; a third port and a fourth port each in fluid communication with the second cavity region; A dialysis machine comprising:

2. the passageway is configured as a constriction region defined at least in part by the flow restricting structure; and / or the dialyzer is configured to have no potting in the area of ​​the passageway; The dialyzer of claim 1.

3. the flow restricting structure is configured to be disposed within or integrally formed with the housing; and / or the flow restriction structure is designed taking into account the expansion characteristics of the hollow fiber membrane during use; and / or the flow-restricting structure is configured to hold the hollow fiber membrane relatively tightly; The dialyzer of claim 1.

4. The flow restricting structure is configured to be formed during or after injection molding of the housing. The dialyzer of claim 1.

5. the flow restricting structure comprises a protrusion formed during injection molding of the housing; or The flow limiting structure is at least partially formed by a contractible structure that can be contracted after injection molding of the housing, in particular after installation of the hollow fiber membrane. The dialyzer according to claim 4.

6. the protrusion is formed by a curved wall portion of the housing; or The dialyzer of claim 5 , wherein the shrinkable structure comprises heat shrink tubing.

7. the heat shrink tube forms at least a portion of the housing or is disposed within the housing; The dialyzer according to claim 6.

8. the first port or the second port is fluidly connected to the third port or the fourth port through a fluid flow control device to control the flow of the medical fluid between the first port or the second port and the third port or the fourth port. The dialyzer of claim 1.

9. 9. The dialyzer of claim 8, wherein the housing has a substantially cylindrical configuration, and the first port, the second port, the third port, and the fourth port are axially spaced apart from one another on the housing in a continuous manner, preferably in a row.

10. the second port and the third port are fluidly connected by the fluid flow control device. The dialyzer according to claim 9.

11. The fluid flow control device comprises an on-off valve and / or a flow restriction. The dialyzer according to claim 8.

12. the on-off valve and the flow restriction are connected in parallel between the second port and the third port; and / or the on-off valve is a solenoid valve; and / or the flow restriction is a variable flow restriction; and / or the fluid flow control device further comprising a flow sensor for detecting a flow rate of the medical fluid between the second port and the third port. The dialyzer of claim 11.

13. The fluid flow control device is integrated as a shunt interlock assembly. The dialyzer according to claim 8.

14. 1. A system for blood treatment comprising: A dialyzer according to claim 1; Blood lines and A medical fluid line; Equipped with The blood line and the medical fluid line are fluidly connected to the dialyzer.

15. The system is configured to perform hemodialysis, hemofiltration, hemodiafiltration, and any combination thereof. The system of claim 14.

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