Blood treatment system

Abstract

Dialyzer systems can integrate the technologies and functions of various blood therapy systems in a significantly integrated manner. For example, this disclosure describes a dialyzer system including a magnetically driven and magnetically levitated pump rotor integrated into the dialyzer. Such a dialyzer can be used with a treatment module including a pump drive unit that generates a magnetic field. In some embodiments, the dialyzer includes a pressure transducer chamber with a flexible membrane, and a corresponding pressure transducer of the treatment module can engage with the flexible membrane to detect arterial and / or venous pressure.

Description

Technical Field

[0001] This invention relates to blood therapy systems and methods for extracorporeal blood therapy procedures. Background Technology

[0002] Kidney dysfunction or failure, especially end-stage renal disease, causes the body to lose its ability to remove water and minerals, maintain acid-base balance, and keep electrolyte and mineral concentrations within physiological ranges. Toxic uremic waste products such as urea, creatinine, and uric acid accumulate in human tissues and can lead to death if the kidneys do not perform their filtering function.

[0003] In the treatment of chronic renal failure, various mechanical purification and blood-treatment methods are used to remove substances that are normally excreted in urine and to aspirate fluid. In hemodialysis (HD), diffusion mass transfer dominates, while in hemofiltration (HF), convection mass transfer through the membrane dominates. Hemodiafiltration (HDF) is a combination of both methods.

[0004] During hemodialysis (HD), blood is drawn from the patient through a dialyzer consisting of a semipermeable membrane that separates the blood from a large volume of externally supplied dialysis solution (also known as dialysate). Waste and toxins, including excess fluid, pass through the semipermeable membrane from the blood into the dialysate, and are then typically discarded. The transport of small molecules across the semipermeable membrane is primarily determined by the concentration difference between the dialysate and the blood. The dialysate before receiving dialysis components from the blood is called "fresh dialysate," and the dialysate leaving the dialyzer after receiving dialyzed components is called "waste dialysate."

[0005] During HDF, a portion of the serum drawn through the semipermeable membrane is replaced by a sterile replacement fluid, which is delivered to the extracorporeal bloodstream either upstream or downstream of the dialyzer. The supply of replacement fluid upstream of the dialyzer is also known as pre-dilution, while the supply downstream of the dialyzer is also known as post-dilution. Summary of the Invention

[0006] The dialyzer system described herein may include a magnetically driven and magnetically levitated pump rotor integrated into the dialyzer. This dialyzer is configured for use with a treatment module as described herein, which includes a pump drive unit that generates a magnetic field. In some embodiments, the dialyzer includes a pressure sensor chamber with a flexible membrane wall, and a corresponding pressure transducer of the treatment module can engage against the flexible membrane wall to detect arterial and / or venous pressure. As described herein, additional features can be incorporated into the dialyzer and treatment module to combine components, simplify setup, and enhance blood therapy performance.

[0007] In one aspect, this disclosure relates to a dialyzer. The dialyzer includes: a housing defining a blood inlet and a blood outlet; a bundle of hollow fibers within the housing; and a pumping device actuated to force blood received from the blood inlet through the lumen of the hollow fibers and out of the blood outlet. The dialyzer also includes a first dialysate port in fluid communication with a dialysate flow path including a space within the housing located between the hollow fibers; and a second dialysate port in fluid communication with the dialysate flow path. The dialyzer further includes a venous pressure detection chamber disposed between the hollow fibers and the blood outlet. The venous pressure detection chamber may have a first flexible surface.

[0008] Such a dialyzer may optionally include one or more of the following features in any combination. The housing may include a first end cap defining a blood inlet and / or a second end cap defining a blood outlet. The first flexible surface may be attached to the second end cap. The dialyzer may also include an arterial pressure sensing chamber disposed between the blood inlet and the hollow fiber and having a second flexible surface. The second flexible surface may be attached to the first end cap. The first end cap may define a first dialysate port. The second end cap may define a second dialysate port. The first end cap may define a first replacement fluid port in fluid communication with the lumen of the hollow fiber. The second end cap may define a second replacement fluid port in fluid communication with the lumen of the hollow fiber. The pumping device may be a pump rotor or included within the first end cap. The dialyzer may be configured to guide fluid (e.g., blood) transversely to the longitudinal axis of the dialyzer into the first end cap. The first end cap may be configured to deliver fluid to the center of the pump rotor. After radially exiting the pump rotor, the fluid may enter an annular space defined by the first end cap around the pump rotor. Fluid from the annular space can be guided towards the hollow fiber through a first end cap. Before reaching the hollow fiber, the fluid can pass through one or more openings defined by an internal support plate within the first end cap. The dialyzer may also include one or more magnets enclosed within a pump rotor. The pump rotor can be magnetically driven to force blood through the lumen of the hollow fiber. The dialyzer may also include one or more magnets attached to the pump rotor. The pump rotor can be magnetically levitated during operation. In some embodiments, the housing includes a degassing chamber. The degassing chamber may be defined within an end cap of the housing. The pumping device may be housed in a fixed position relative to the hollow fiber.

[0009] In another aspect, this disclosure relates to a blood therapy device. The blood therapy device may include a treatment module comprising structures for releasable coupling with a dialyzer. The treatment module may include: (i) a first pressure transducer positioned against a first membrane of a first pressure detection chamber of the dialyzer when the dialyzer is coupled to the treatment module; and (ii) a second pressure transducer positioned against a membrane of a second pressure detection chamber of the dialyzer when the dialyzer is coupled to the treatment module.

[0010] Such a blood therapy device may optionally include one or more of the following features in any combination. A first pressure transducer and a second pressure transducer may be positioned adjacent to opposite ends of the dialyzer when the dialyzer is coupled to the treatment module. The first and second pressure transducers may be reconfigured between: (i) a first position in which the first and second pressure transducers are retracted; and (ii) a second position in which the first and second pressure transducers extend to abut against the first and second membranes, respectively. The treatment module may also include a first door configured to open and close a first opening; and / or a second door configured to open and close a second opening. The first pressure transducer may be adjacent to the first door. The second pressure transducer may be adjacent to the second door. In some embodiments, the treatment module may be reconfigured between: (i) a first configuration in which the first and second pressure transducers are retracted behind the first and second doors, respectively; and (ii) a second configuration in which the first and second doors are open and the first and second pressure transducers extend through the first and second openings, respectively. The treatment module may further include: a first pair of tubing configured to connect to a first replacement fluid port and a first dialysate port defined by the dialyzer when the dialyzer is coupled to the treatment module; and / or a second pair of tubing configured to connect to a second replacement fluid port and a second dialysate port defined by the dialyzer when the dialyzer is coupled to the treatment module. In the first configuration, the first pair and / or the second pair of tubing may retract behind a first door and a second door, respectively. In the second configuration, the first pair and / or the second pair of tubing may extend through a first and a second opening, respectively. In some embodiments, the treatment module includes a pump drive unit configured to generate a dynamic magnetic field to levitate and rotate a magnetic pump rotor within the dialyzer when the dialyzer is coupled to the treatment module. The blood therapy machine may further include a blood therapy machine control console for controlling the treatment module. The treatment module may be mounted to an arm extending from the blood therapy machine control console. In some embodiments, the treatment module or the arm to which the treatment module is mounted may include one or more sensors operable to determine the orientation or movement of the blood therapy module relative to the blood therapy machine control console. Structures for releasably coupling with a dialyzer may include a groove shaped to slidably receive a portion of the dialyzer.

[0011] In another aspect, this disclosure relates to a blood therapy system. The blood therapy system includes: a treatment module and a dialyzer releasably coupled to the treatment module. The dialyzer includes: a housing; a bundle of hollow fibers within the housing; and a first pressure sensing chamber having an outer wall including a membrane. The treatment module includes a first pressure transducer positioned to abut against the membrane of the first pressure sensing chamber when the dialyzer is coupled to the treatment module.

[0012] Such a blood therapy system may optionally include one or more of the following features in any combination. The dialyzer may also include a pump rotor located within a housing. The pump rotor is magnetically actuated to force fluid through the inner cavity of a hollow fiber. The treatment module may include a pump drive unit that generates a dynamic magnetic field to suspend and rotate the pump rotor when the dialyzer is coupled to the treatment module. In some embodiments, the dialyzer further includes a second pressure sensing chamber having an outer wall including a membrane. The treatment module may also include a second pressure transducer positioned against the membrane of the second pressure sensing chamber when the dialyzer is coupled to the treatment module. The dialyzer may include a first end cap defining a first pressure sensing chamber and / or a second end cap defining a second pressure sensing chamber. The blood therapy system may also include a blood therapy machine console for controlling the treatment module. The treatment module may be mounted on an arm extending from the blood therapy machine console. Mounting the treatment module to the arm allows the treatment module and the dialyzer to be positioned close to the patient during treatment. In some embodiments, the treatment module or the arm to which the treatment module is mounted may include one or more sensors operable to determine the orientation or movement of the blood therapy module relative to the blood therapy machine console. Patient tubing less than one meter in length, whether venous or arterial, can be connected to a dialyzer.

[0013] The embodiments may include one or more of the following advantages.

[0014] In some embodiments, various technologies and functions of the blood therapy system are integrated into the dialyzer and treatment module system described herein in a significantly improved and integrated manner. For example, in some embodiments, a single dialyzer unit, as further described below, can replace significant portions, tubing, air removal systems, sample ports, and pumps of a conventional hollow fiber dialyzer. Furthermore, the end caps of some dialyzers described herein may include an accessible pressure chamber with a flexible membrane wall for convenient, non-invasive measurement of arterial and venous pressures. In some embodiments, the end cap of the dialyzer may include (a) a port for receiving fresh dialysate from the treatment module, and (b) a port for returning waste dialysate to the treatment module after passing through the dialysis membrane. In some embodiments, the end cap of the dialyzer may also include a port through which replacement fluid can be added directly to the blood before and / or after the blood passes through the hollow fiber blood therapy section of the dialyzer. Additionally, in some embodiments, the same dialyzer and treatment module system is configured to perform any of a variety of different types of blood therapy, including, for example, HD and HDF.

[0015] Compared to typical HD and HDF machines, some example embodiments reduce the number of setup steps required, which can reduce setup time and the chance of human error. In clinics, this can free up valuable nursing resources and simplify patient care. This simplification can free up nursing or other personnel resources in clinic or home settings and make the process of patients configuring their own dialysis machines easier and more feasible.

[0016] In some embodiments, the integrated dialyzer and treatment module system described herein offers significant functional advantages. For example, integration reduces the amount of tubing required for the extracorporeal circuitry used during hemotherapy. Furthermore, the treatment module can be mounted on an arm extending from the hemotherapy machine console, allowing the treatment module and dialyzer to be placed very close to the patient. These features significantly reduce the length of extracorporeal tubing required for hemotherapy. Consequently, the volume of perfusion solution required is advantageously reduced. Additionally, patient blood exposure to foreign surfaces is advantageously reduced. The integrated form factor also provides other advantages such as reduced likelihood of leakage, less hemolysis, less biohazardous waste, less packaging waste, and reduced transportation costs.

[0017] In some embodiments, the magnetic pump rotor is integrated into the dialyzer in a liquid-tight manner. This integrated pump rotor can be bearingless, magnetically levitated, and rotatably driven by an external pump drive unit that generates a dynamic magnetic field. Compared to conventional pumping systems used for extracorporeal blood therapy, this arrangement offers advantages such as reduced hemolysis, and the bearingless design reduces system maintenance requirements and the likelihood of contamination. Furthermore, the separate nature of the pump drive unit and pump rotor advantageously facilitates easier cleaning of the machine interface.

[0018] In some embodiments, the integrated dialyzer and treatment module system described herein is also easier to set up and use compared to conventional systems. Therefore, setup time can be reduced, and the possibility of errors can be decreased. Consequently, in some embodiments, treatment costs per patient can be reduced.

[0019] Details of one or more embodiments are set forth in the accompanying drawings and the following description. Other aspects, features, and advantages will become apparent from the specification, the drawings, and the claims. Attached Figure Description

[0020] Figure 1 The image shows a patient receiving extracorporeal blood therapy using a blood therapy system.

[0021] Figure 2 yes Figure 1 An exploded perspective view of the dialyzer and treatment module system of a blood therapy system.

[0022] Figure 3 It is in a single assembly configuration Figure 2 A perspective view of the dialyzer and treatment module system.

[0023] Figure 4 yes Figure 1 A schematic diagram of a dialyzer in a blood therapy system, showing the blood flow path through the dialyzer.

[0024] Figure 5 yes Figure 1 Another schematic diagram of a dialyzer for a blood therapy system shows the blood flow path through the dialyzer and the location where the replacement material is added.

[0025] Figure 6 yes Figure 1 Another schematic diagram of a dialyzer for a blood therapy system shows the flow path of dialysate through the dialyzer.

[0026] Figure 7 yes Figure 1 Another schematic diagram of a dialyzer for a blood therapy system shows the flow paths of blood and dialysate, as well as the location where the replacement material is added.

[0027] Figure 8 yes Figure 1 Rear view of a dialyzer in a blood therapy system.

[0028] Figure 9 yes Figure 1 Front view of a dialyzer in a blood therapy system.

[0029] Figure 10 yes Figure 1A side view of a dialyzer in a blood therapy system, showing in part the arterial and venous tubing.

[0030] Figure 11 yes Figure 1 A top view of a dialyzer in a blood therapy system, showing in part the arterial and venous tubing.

[0031] Figure 12 yes Figure 1 The dialyzer of the blood therapy system along Figure 10 A sectional view made using section line AA.

[0032] Figure 13 yes Figure 1 The dialyzer of the blood therapy system along Figure 11 The sectional view is a cut-off view made by section line BB.

[0033] Figure 14 yes Figure 1 The second end cap of the dialyzer in the blood therapy system along Figure 11 The cross-sectional view is taken from section line CC, where the position of the dialyzer filling is shown in dashed lines.

[0034] Figure 15 yes Figure 1 The dialyzer of the blood therapy system along Figure 10 A sectional view made by section line DD.

[0035] Figure 16 yes Figure 1 The dialyzer of the blood therapy system along Figure 10 A sectional view made using section line EE.

[0036] Figure 17 yes Figure 1 The dialyzer of the blood therapy system along Figure 11 The cross-sectional view is made by section line BB, in which the bundles of hollow fibers and the filling are shown in dashed lines.

[0037] Figure 18 yes Figure 1 The dialyzer of the blood therapy system along Figure 10 A sectional view made using section line FF.

[0038] Figure 19 yes Figure 1 The dialyzer of the blood therapy system along Figure 10 The sectional view made by section line GG.

[0039] Figure 20 yes Figure 1 A perspective view of the first end cap of a dialyzer in a blood therapy system.

[0040] Figure 21 yes Figure 20 Rear view of the first end cap.

[0041] Figure 22 yes Figure 20 Another perspective view of the first end cap.

[0042] Figure 23 yes Figure 20 The first end cap is shown in a partial longitudinal sectional view and a perspective view showing the blood flowing through it.

[0043] Figure 24 It is configured to be located in Figure 20 A perspective view of the pump rotor in the first end cover.

[0044] Figure 25 It can be used Figure 20 A perspective view of the alternative pump rotor in the first end cover.

[0045] Figure 26 yes Figure 1 A perspective view of the second end cap of a dialyzer in a blood therapy system.

[0046] Figure 27 yes Figure 26 Rear view of the second end cap.

[0047] Figure 28 yes Figure 26 Another perspective view of the second end cap.

[0048] Figure 29 This is a cross-sectional view of the alternative second end cap.

[0049] Figure 30 It is in the first configuration Figure 1 A perspective view of the treatment module of the blood therapy system.

[0050] Figure 31 It is in the second configuration Figure 30 A perspective view of the treatment module.

[0051] Figure 32 It shows Figure 20 First end cap and Figure 30 An exploded perspective view of the first pressure sensor and the first pair of pipes in the treatment module.

[0052] Figure 33 It is shown in a separate configuration. Figure 32 Top perspective view of the first end cap, the first pressure sensor, and the first pair of pipes.

[0053] Figure 34 It is shown in an operable coupling configuration. Figure 32 Top perspective view of the first end cap, the first pressure sensor, and the first pair of pipes.

[0054] Figure 35 This is a perspective view of the alternative therapy module.

[0055] Figure 36 This is a perspective view of the alternative first (arterial) endcap, shown in a partial longitudinal sectional view.

[0056] Figure 37 It is configured to be similar to Figure 1 Rear view of an exemplary dialyzer for a blood therapy system (except for the absence of HDF function).

[0057] Figure 38 yes Figure 37 Front view of a dialyzer.

[0058] Figure 39 yes Figure 37 A side view of a dialyzer.

[0059] Figure 40 This is a longitudinal sectional view of an alternative second (venous) end cap.

[0060] Figure 41 It shows Figure 40 A perspective view of a portion of the venous cap.

[0061] Figure 42 This is a perspective view of a portion of another alternative second (venous) endcap.

[0062] Figure 43 yes Figure 42 A longitudinal sectional view of the venous cap.

[0063] Figure 44 yes Figure 42 Another perspective view of the venous cap.

[0064] Figure 45 This is a longitudinal sectional view of another alternative second (venous) end cap. The venous end cap is shown in the first configuration.

[0065] Figure 46 It is in the second configuration Figure 45 A longitudinal sectional view of the venous cap.

[0066] Figure 47 It shows Figure 45 A perspective view of a portion of the venous cap.

[0067] Similar reference numerals in the various figures indicate similar elements. Detailed Implementation

[0068] This disclosure describes a dialyzer system that may include a magnetically driven, magnetically levitated pump rotor integrated into the dialyzer. Such a dialyzer can be used with a treatment module described herein, which includes a pump-driven unit that generates a dynamic magnetic field. In some embodiments, the dialyzer includes one or more pressure sensor chambers with flexible outer membrane walls, and a corresponding pressure transducer of the treatment module engages with the flexible outer membrane walls to detect arterial and / or venous pressure. The dialyzer system described herein integrates multiple technologies and functions of blood therapy systems in a significantly integrated manner to consolidate components, reduce costs, simplify setup, and enhance performance.

[0069] refer to Figure 1 Patient 10 is shown receiving extracorporeal blood therapy using a blood therapy system 1, which includes a disposable component connected to a blood therapy machine 200. This disposable component includes a dialyzer 100 coupled to a treatment module 220 of the blood therapy machine 200. In some cases, patient 10 may receive treatment for a health condition such as kidney failure. Therefore, system 1 can be used to provide patient 10 with one or more types of treatment, including hemodialysis (HD), hemodiafiltration (HDF), or some other type of blood therapy. For such treatment, blood is drawn from patient 10 via an arterial line 102, and after passing through the dialyzer 100, the treated blood is returned to patient 10 via a venous line 104. The dialyzer 100 is a single-use, disposable item, while the blood therapy machine 200 is a durable, reusable system. In some cases, a single dialyzer 100 may be reused two or more times for a specific individual patient.

[0070] The blood therapy machine 200 includes a blood therapy machine control console 210, a treatment module 220, and an arm 280 connecting the treatment module 220 to the blood therapy machine control console 210. The arm 280 extends from the blood therapy machine control console 210, and the treatment module 220 is mounted to the other end of the arm 280. In other words, the treatment module 220 cantilevered from the blood therapy machine control console 210 via the arm 280.

[0071] Arm 280 includes one or more adjustable joints, allowing arm 280 to be manually hinged to position treatment module 220 relative to blood therapy machine control console 210 and / or relative to patient 10 in various positions / or orientations. For example (e.g.) Figure 1As shown in the diagram, in some cases, arm 280 can extend to position treatment module 220 close to patient 10. Therefore, compared to conventional blood therapy systems, arterial line 102 and venous line 104 can be very short. For example, in some embodiments, the length of arterial line 102 and venous line 104 is less than one meter (e.g., less than 90cm, less than 80cm, less than 70cm, less than 60cm, less than 50cm, less than 40cm, less than 30cm, or less than 20cm).

[0072] In some embodiments, the treatment module 220 and / or arm 280 may include one or more sensors 226 whose outputs may indicate the position, orientation, and / or movement of the treatment module 220 relative to the blood therapy machine control console 210. For example, in some cases, sensors such as accelerometers (e.g., 3D accelerometers), gyroscope sensors, ultrasonic sensors, proximity sensors, optical sensors, magnetometers, GPS sensors, radio triangulation sensors (e.g., those used in keyless entry systems for automobiles or based on WiFi, Bluetooth, or similar technologies), electronic levels, electric levels, and / or similar sensors within the treatment module 220 and / or arm 280 may be used to indicate the position, orientation, and / or movement of the treatment module 220 relative to the blood therapy machine control console 210.

[0073] In some embodiments, the signal output from such sensor 226 can be used as an input to the control system of the blood therapy system 1, for example, to activate or deactivate certain operating modes of the blood therapy system 1, or, optionally, to determine the current status of the treatment module 220. For example, a particular orientation of the treatment module 220 can be used to indicate that a maintenance mode should be activated. Pulling the treatment module 220 forward toward the patient can initiate preparation for a treatment mode. Another particular orientation of the treatment module 220 can be defined as indicating activation of a degassing mode. Pushing the treatment module 220 back toward the blood therapy machine control console 210 can serve as an input for pausing the operation of the blood therapy system 1, and so on. Other operating modes of the blood therapy system 1 that can be activated in response to a particular position, orientation, or movement of the treatment module may include, but are not limited to, “nurse mode,” adjustment mode, and filling or perfusion mode, to provide some examples. Sensor 226, which includes one or more outputs that can indicate the position, orientation, and / or movement of the treatment module 220 relative to the blood therapy machine control console 210, allows the user to conveniently and intuitively control interaction with the blood therapy system 1 by manually operating the treatment module 220 mounted on the arm. Electronic devices and / or control units that receive and interpret output signals from sensor 226 may be located in the blood therapy machine console 210, treatment module 220, arm 280, and / or other locations. In some embodiments, raw data from one or more sensors 226 is processed in a separate step to generate sensor outputs used in further steps. In some embodiments, the processor performing this processing step is located in treatment module 220. In some embodiments, the processor performing this processing step is located in arm 280. In some embodiments, the processor performing this processing step is located in blood therapy machine console 210.

[0074] In some embodiments, sensors are additionally or alternatively present in the arm 280 to determine the position and / or orientation of the treatment module 220. Such sensors may be angle sensors, path sensors, range sensors, and / or other types of sensors. In some embodiments, such sensors may be used to identify whether a mechanical impact has occurred, such as a mechanical impact in which a person or object comes into contact with the treatment module 220. When an alarm simultaneously occurs in other sensors triggered by an impact event, the detection of the impact event can be used to identify the alarm as a false alarm. For example, an ultrasonic bubble detector may generate a sensor reading at the time of an impact event, thus triggering an alarm. An accelerometer or position sensor in the treatment module 220 and / or the arm 280 is capable of detecting the impact event occurring at the time of the alarm. In this case, the treatment module control device may progressively downgrade the alarm, considering that the bubble detector reading may have been spoofed due to the likelihood that the detected impact event has been faked.

[0075] Other advantages of using such a sensor as described above include the ability to initiate an operational state using sensor readings in conjunction with degassing or infusion modes, thereby reducing the workload of the operator of the treatment module 220. Additionally, the tactile input channel will allow for more intuitive operation of the treatment module 220. Furthermore, these concepts can help avoid errors and mistakes during operation and treatment, and error alarms can be identified.

[0076] In some embodiments, the output signal from sensor 226 may be directed to a control unit in treatment module 220 and / or console 210, and the control unit may be configured or programmed to disable or enable predefined processes of the blood therapy system 1 based on the signal. In some embodiments, the perfusion phase of dialyzer 100 (meaning filling dialyzer 100 with liquid and degassing dialyzer 100) and / or the treatment phase of blood therapy system 1 are enabled only when the signal indicates that dialyzer 100 is in a vertical position. In some embodiments, the signal from sensor 226 must indicate the angular position of treatment module 220 relative to the ground (horizontal relative to the earth) such that any liquid that may flow out of the liquid loop does not drip to the ground, but is conducted along the surface of treatment module 220 and directed to the liquid collection port of treatment module 220. The liquid collection port may be connected to a container via a guide rail along the lower end of treatment module 220 to collect leaked liquid.

[0077] The control unit can be further connected to a user interface, such as user interface 212. This user interface can be a graphical user interface and an optical illumination system, a sound generation system, or any combination thereof. The user interface can be configured to display the orientation of the treatment module 220 (e.g., provided via signals from sensor 226), and the display can change its visible appearance according to the enabled process.

[0078] In one example embodiment, when the next process step is, for example, the infusion stage, the graphical user interface will display the orientation of the treatment module 220. The orientation will only be displayed in green when the treatment module 220 is in an upright position (as detected by a signal from sensor 226), and the operator will be able to manually initiate the infusion stage via user interface actions (e.g., voice, buttons, gestures, etc.), or the system will automatically initiate the next process step.

[0079] Although the illustrated example includes a treatment module 220 movable relative to the base console 210, it should be understood that some other examples do not include a separately locatable treatment module 220. In such examples, the base console 210 may include other features described for the illustrated treatment module 220, in addition to those specific features for locatability.

[0080] The blood therapy machine control console 210 includes a user interface 212, a control system, facilities for preparing dialysis fluid, etc.

[0081] In the blood therapy system 1, most of the components associated with conventional systems are integrated into the portion of the dialyzer 100 and blood therapy module 220 that engages with the dialyzer 100. Conventional blood therapy systems typically include disposable tubing assemblies and / or cartridges (in addition to the dialyzer). Such tubing assemblies and / or cartridges are used to engage with one or more pieces of hardware such as pumps, sensors, valve actuators, etc. However, the dialyzer 100 and blood therapy machine 200 integrate multiple functions in a highly integrated manner (as further described below).

[0082] Also refer to Figure 2 and Figure 3 The dialyzer 100 is conveniently and releasably coupled to the treatment module 220. For example, in the illustrated embodiment, the dialyzer 100 is slidably coupled to the treatment module 220. Therefore, the dialyzer 100 and the treatment module 220 include complementary structural features to facilitate slidable coupling. In other words, the dialyzer 100 includes a first protrusion 106 slidably coupled to a first complementary-shaped groove 222 of the treatment module 220, and the dialyzer 100 includes a second protrusion 108 slidably coupled to a second complementary-shaped groove 224 of the treatment module 220. In some embodiments, other methods of releasably connecting the dialyzer 100 to the treatment module 220 may be used. For example, in some embodiments, connection methods such as snap-fit ​​connections, finger-screw connections, clamp connections, and magnetic connections may be used.

[0083] The dialyzer 100 includes a housing 110 defining an internal space. Bundles of hollow fiber semipermeable membranes (or simply "hollow fibers") are arranged inside the housing 110. Arterial lines 102 and venous lines 104 extend from the housing 110 (e.g., from opposite ends of the housing 110) and are in fluid communication with the interior of the housing 110 and the lumen of the hollow fibers.

[0084] The housing 110 includes a first end cap 120 and a second end cap 140. The first end cap 120 includes a first protrusion 106, and the second end cap 140 includes a second protrusion 108. In addition, an arterial line 102 is coupled to the first end cap 120, and a venous line 104 is coupled to the second end cap 140.

[0085] The treatment module 220 includes a pump drive unit 230 configured to releasably receive a portion of the first end cap 120. As further described below, the pump drive unit 230 generates a dynamic magnetic field to suspend and rotate a pump rotor housed within a portion of the first end cap 120. In some embodiments, the pump drive unit 230 does not include moving parts.

[0086] The pump rotor is configured such that rotation of the pump rotor forces the patient's blood from the patient 10 through the lumen of the hollow fiber of the dialyzer 100 in a direction from the first end cap 120 toward the second end cap 140. Thus, blood from the patient 10 flows into the dialyzer 100 via the arterial line 102, through the lumen of the hollow fiber, and out of the dialyzer 100 via the venous line 104.

[0087] Treatment module 220 also includes other means for engaging arterial line 102 and / or venous line 104. For example, the illustrated treatment module 220 includes a tube engagement module 240 configured to releasably receive a portion of arterial line 102 and / or a portion of venous line 104. Tube engagement module 240 may include means capable of performing functions such as flow rate detection, bubble detection, etc. In other words, tube engagement module 240 may include sensors for detecting one or more parameters (e.g., blood flow rate, hematocrit (Hct), and other blood properties within arterial line 102 and / or venous line 104) and / or for detecting air bubbles (e.g., air bubbles) in the blood within arterial line 102 and / or venous line 104. In some embodiments, sensors such as ultrasonic sensors, optical sensors, or other suitable types of sensors are used to perform flow rate detection and / or bubble detection. In other embodiments, the sensor for detecting bubbles may be located at or within the end cap of a disposable item of dialyzer 100.

[0088] The treatment module 220 also includes an arterial line clamp 242 and a venous line clamp 244. Clamps 242 and 244 are used to completely restrict or completely unrestrict (e.g., by opening / closing valves) the flow of blood within the arterial line 102 and / or the venous line 104, respectively.

[0089] As further described below, the treatment module 220 also includes means for engaging with the dialyzer 100 to measure pressure at a specific location within the dialyzer 100. Additionally, as further described below, the treatment module 220 includes conduits that can be selectively engaged with the dialyzer 100 to facilitate the flow of fluids such as replacement material and / or dialysate between the dialyzer 100 and the treatment module 220.

[0090] Figures 4 to 7 This is a schematic diagram of dialyzer 100. For ease of understanding, Figure 4 Only the blood flow through dialyzer 100 is shown. Figure 5 The flow of blood and replacement material is shown. Figure 6 Only the flow of the dialysate is shown. Figure 7 The flow of blood, replacement material, and dialysate is shown.

[0091] Figures 4 to 7Simplified to illustrate the overall flow relationships within dialyzer 100. For example, the first and second perfusions 115 and 116 at the two corresponding ends of each fiber in the bundle of anchoring hollow fibers 114 are omitted for simplification. In addition to the bundle of anchoring hollow fibers, these perfusions 115 and 116 also maintain a barrier between the blood and dialysate. The perfusions 115 and 116, and the associated flow paths, are described below. Figures 8 to 29 Further detailed description.

[0092] refer to Figure 4 The dialyzer 100 housing 110 includes a first end cap 120, a second end cap 140, and an intermediate housing portion 112 extending between the first end cap 120 and the second end cap 140. The intermediate housing portion 112 contains most of the length of a bundle of hollow fibers 114. As described above, the following describes... Figures 8 to 29 The description provides a more detailed description of the structure of the dialyzer 100, including the bundle of hollow fibers 114.

[0093] The first end cap 120 includes a pump housing 130. A rotatable centrifugal pump rotor 132 is located within the pump housing 130. The pump rotor 132 is enclosed or covered within the pump housing 130. Thus, the pump rotor 132 is housed in a fixed position relative to the bundle of hollow fibers 114.

[0094] According to some embodiments, the pump rotor 132 is a radial pumping impeller having a hollow central volume region. The blades (or vanes) of the pump rotor 132 are arranged such that they at least partially project radially or extend. In some cases, the vanes are arranged to project or extend completely radially. In some cases, the vanes are arranged to project or extend partially radially and partially tangentially.

[0095] As further described herein, via the pump drive unit 230 of the treatment module 220 ( Figure 2 and Figure 3 (As shown) The pump rotor 132 is operated and controlled by engaging the magnetic field emitted from the pump drive unit 230. That is, the pump rotor 132 can be levitated and rotated during use by a magnetic field emitted from the pump drive unit 230.

[0096] Housing 110 defines one or more pressure sensing chambers. The illustrated embodiment includes an arterial pressure sensing chamber 122 and a venous pressure sensing chamber 142. The arterial pressure sensing chamber 122 is located prior to the pump rotor 132. That is, the arterial pressure sensing chamber 122 is arranged to facilitate the measurement of arterial pressure before the pump. Additionally or alternatively, in some embodiments, pressure may also be measured after the pump (but prior to the hollow fiber 114). As further described below, both pressure sensing chambers 122 and 142 are configured to engage with corresponding pressure transducers of the treatment module 220.

[0097] Now refer to Figure 4 The dashed lines in the diagram illustrate the blood flow path through the dialyzer 100. Blood flows through the arterial tubing 102 (in... Figure 2 and Figure 3 (As shown in the diagram) Blood flows into the first end cap 120. The fluid flow path into the first end cap 120 is transverse to the longitudinal axis of the dialyzer 100. The arterial pressure detection chamber 122 is positioned along this flow path after entering the first end cap 120 but before the pump rotor 132. The blood flow path transitions to be parallel to the longitudinal axis of the dialyzer 100 to deliver blood to the pump rotor 132. The blood is directed to the center of the pump rotor 132. The rotation of the centrifugal pump rotor 132 forces the blood to flow radially outward from the pump rotor 132. Then, after flowing radially outward from the pump rotor 132, the blood turns and flows longitudinally towards the intermediate housing portion 112. The blood enters the lumen of the bundle of hollow fibers 114 and continues to flow longitudinally towards the second end cap 140. After passing through the intermediate housing portion 112, the blood flows out of the bundle of hollow fibers 114, enters the second end cap 140, and flows transversely out of the second end cap 140 via the venous line 104. A venous pressure detection chamber 142 is positioned within a second end cap 140 along the blood flow path. In some embodiments, a one-way check valve is positioned along the blood flow path as blood flows out of the second end cap 140 and into the venous line 104. In some embodiments, the one-way check valve includes a side arm connection structure to the blood flow path to prevent backflow or blood from entering the side arm connection structure.

[0098] The second end cap 140 can also be configured to degas the blood as it enters and flows through it. Therefore, the second end cap 140 includes an air purging element 144 that allows air and other gases to exit the second end cap 140 while preventing fluids such as blood from flowing out. The air purging element 144 can also serve as an inlet port. That is, the air purging element 144 can be configured for uses such as sample extraction and administration of drugs (e.g., heparin). The air purging element 144 may include a plastic tube extending from the second end cap 140. A resilient seal located within the plastic tube is configured to open when a needleless syringe is coupled to the air purging element 144.

[0099] Again, the blood purified and treated by dialyzer 100 flows through the lumen of hollow fibers 114 (while dialysate flows through dialyzer 100 on / along the outside of hollow fibers 114 in the space between the outside of hollow fibers 114, as further described herein). This is exactly different from how blood flows through extracorporeal blood oxygenator devices (which also use hollow fibers made of permeable material). Extracorporeal blood oxygenators are used to perform treatments such as extracorporeal membrane oxygenation (“ECMO”) and, in conjunction with cardiopulmonary bypass machines, for surgical procedures such as coronary artery bypass grafting (“CABG”), heart valve replacement / repair, heart transplantation, and so on. Although extracorporeal blood oxygenators, like dialyzer 100, may include bundles of hollow fibers made of permeable material, blood flowing through extracorporeal blood oxygenators flows on / along the outside of hollow fibers (as opposed to flowing through the lumen of hollow fibers as in dialyzer 100), and gas flows through the lumen of hollow fibers.

[0100] Therefore, because the type of blood flow path in dialyzer 100 is fundamentally different compared to that in an extracorporeal blood oxygenator, the pressure and flow parameters of blood passing through dialyzer 100 differ significantly from those of blood passing through an extracorporeal blood oxygenator. Table 1 below shows some blood pressure and flow parameters for dialysis (using a dialyzer) and extracorporeal oxygenation (using an extracorporeal blood oxygenator).

[0101]

[0102] Table 1

[0103] The pressure-to-flow rate ratio associated with the blood flowing through a dialyzer or extracorporeal oxygenator can also be referred to as the "hemolysis risk factor." The risk of hemolysis (damage to red blood cells) increases with the pressure-to-flow rate ratio. Therefore, the term "hemolysis risk factor" quantifies a useful parameter related to the physical construction and use of dialyzers and extracorporeal oxygenator devices.

[0104] As can be seen from Table 1, for example, the hemolytic risk factor (pressure-to-flow rate ratio during use) experienced by blood using dialyzer 100 is much higher compared to extracorporeal oxygenation. For example, in the example in Table 1, the hemolytic risk factor for dialysis is 3.11, while the hemolytic risk factor for extracorporeal oxygenation is 0.33. This is approximately a 10:1 difference. In other words, the pressure-to-flow rate ratio, or hemolytic risk factor, during dialysis is approximately 10 times higher than during extracorporeal oxygenation. This comparison is one way to illustrate and understand the substantial physical differences between dialyzers (e.g., dialyzer 100) and extracorporeal oxygenation devices.

[0105] refer to Figure 5The dialyzer 100 is also configured to receive one or more replacement fluids combined with blood within the dialyzer 100. For example, in the illustrated embodiment, a first end cap 120 defines a first replacement fluid port 124, and a second end cap 140 defines a second replacement fluid port 148. The first replacement fluid port 124 is in direct fluid communication with the inflow path defined by the first end cap 120 and merges with it before the arterial pressure detection chamber 122. Alternatively, in some embodiments, the replacement fluid may be added to the blood after exiting the pump housing 130 (i.e., after being pressurized by the pump rotor 132) but before entering the lumen of the hollow fiber 114. The second replacement fluid port 148 is in direct fluid communication with the outflow path defined by the second end cap 140 and merges with it after the venous pressure detection chamber 142. Each of the replacement fluid ports 124 and 148 may each include a corresponding one-way check valve to prevent fluid from leaving the end caps 120 and 140 via the replacement fluid ports 124 and 148.

[0106] refer to Figure 6 The dialyzer 100 is also configured to receive dialysate and guide its flow through a housing 110. For example, in the illustrated embodiment, a second end cap 140 defines a dialysate inlet 149, and a first end cap 120 defines a dialysate outlet 125. The dialysate flows into the second end cap 140 via the dialysate inlet 149 and then into an intermediate housing portion 112 comprising a bundle of hollow fibers 114. The dialysate flows through the intermediate housing portion 112 via a space defined between the outer diameters of the fibers of the bundle of hollow fibers 114. In other words, as blood flows within the lumen of the fibers of the bundle of hollow fibers 114, the dialysate flows along the outer side of the fibers. The semi-permeable walls of the fibers of the bundle of hollow fibers 114 separate the dialysate from the blood. The dialysate flows out of the intermediate housing portion 112 and into the first end cap 120. The dialysate exits the first end cap 120 via the dialysate outlet 125.

[0107] refer to Figure 7 The flow paths of blood, replacement material, and dialysate are now shown in combination (as described above, refer to the diagrams above). Figures 4 to 6 (As described) (e.g., what will happen during the use of dialyzer 100). When a replacement is added, it combines directly with the blood in end caps 120 and / or 140. Instead, dialyzer 100 keeps the dialysate separate from the blood. However, waste products from the blood (e.g., urea, creatinine, potassium, and additional fluids) are transferred from the blood to the dialysate via osmosis through the semi-permeable walls of the bundles of hollow fibers 114 in dialyzer 100.

[0108] refer to Figures 8 to 10 The top is on Figures 4 to 7The description of the structure and function of the dialyzer 100 provided in the schematic diagram can be used to facilitate understanding of the structure and function of the actual embodiment of the dialyzer 100 shown herein. The dialyzer 100 includes a housing 110 comprising a first end cap 120, an intermediate housing portion 112 containing a bundle of hollow fibers 114, and a second end cap 140. An arterial line 102 is connected to the first end cap 120. A venous line 104 is connected to the second end cap 140. In this example, the arterial line 102 and the venous line 104 are permanently coupled (e.g., solvent-bonded, laser-welded, etc.) to the first end cap 120 and the second end cap 140, respectively. However, it should be understood that in other examples, one or both of these connections may utilize any other suitable permanent or removable liquid-tight connection, including, for example, press-fit and snap-lock connectors.

[0109] The first end cap 120 includes a pump housing 130, a first replacement fluid port 124, and a dialysate outlet 125. The first end cap 120 also includes an arterial pressure detection chamber 122. The outer wall of the arterial pressure detection chamber 122 (as shown in...) Figure 8 (As can be seen in the rear view) includes a flexible membrane 160. As further described herein (e.g., refer to...) Figures 31 to 33 When the dialyzer 100 operates together with the treatment module 220, the pressure transducer of the treatment module 220 (e.g., Figures 1 to 3 and Figure 30 It engages with (e.g., abuts against) the flexible membrane 160 of the arterial pressure detection chamber 122.

[0110] The second end cap 140 includes a second replacement fluid port 148, a dialysate inlet 149, and a venous pressure monitoring chamber 142. The outer wall of the venous pressure monitoring chamber 142 (as shown in...) Figure 8 (As can be seen in the rear view) includes a flexible membrane 162. As further described herein (e.g., refer to...) Figures 31 to 33 When the dialyzer 100 operates together with the treatment module 220, the pressure transducer of the treatment module 220 (e.g., Figures 1 to 3 and Figure 30 It engages (e.g., abuts against) the flexible membrane 162 of the venous pressure detection chamber 142. The air purging member 144 is also attached to the second end cap 140 and is in fluid communication with the interior of the second end cap 140.

[0111] refer to Figures 20 to 22 Here, the first end cap 120 is shown separated from the rest of the dialyzer 100 to make the structural details of the first end cap 120 more visible. Figure 21 and 22 The arterial flexible membrane 160 is not shown in the image to illustrate other features of the arterial pressure detection chamber 122. See also... Figure 16The cross-sectional view shows blood to be treated in dialyzer 100 flowing into first end cap 120 via arterial line 102. Blood enters arterial mixing chamber 163, and then flows from arterial mixing chamber 163 into arterial pressure sensing chamber 122. For example, when blood treatment system 1 is operating in pre-diluted HDF mode, blood can pass through arterial mixing chamber 163 undiluted or mixed with replacement fluid.

[0112] When a replacement material is added to the arterial mixing chamber (e.g., pre-diluted HDF), the replacement material flows into the first end cap 120 from the first replacement material supply line 254 via the first replacement fluid port 124. The replacement material then flows through the arterial replacement material supply line 165. The replacement material then passes through the check valve 167 and enters the arterial mixing chamber 163. The flow of the replacement material is via… Figure 16 A series of arrows are shown extending from the first replacement fluid inlet 124 to the outlet of the check valve 167. In the arterial mixing chamber 163, the replacement fluid mixes with the incoming arterial blood flow (indicated by the upward-pointing arrows) before passing through the arterial pressure detection chamber inlet 122i. The check valve 167 prevents blood from flowing into the arterial replacement fluid supply line 165 and the first replacement fluid inlet 124. This prevents the first replacement fluid supply line 254 from being contaminated with blood.

[0113] Blood (undiluted or diluted with a displacer, depending on the operating mode of the treatment system 1) flows through the arterial pressure detection chamber inlet 122i and into the arterial pressure detection chamber 122. The blood flow through the arterial pressure detection chamber 122 allows the arterial pressure transducer 250 of the blood therapy module 220 to... Figures 31 to 33 (As shown) Arterial blood pressure is measured via membrane 160. (As shown) Figure 13 As indicated by the arrow, blood exits the arterial pressure detection chamber 122 via the outlet 122o. After exiting the arterial pressure detection chamber 122, the blood then flows through the rotor supply tube 103 to the pump housing 130. The rotor supply tube 103 defines a fluid flow path transverse to the longitudinal axis Z of the dialyzer 100.

[0114] The first end cap 120 also includes a dialysate outlet 125. Dialysate flows from the peripheral inner wall region of the first end cap 120 through the dialysate outlet tube 126 to the dialysate outlet 125. For example... Figure 16 As shown, a one-way flow valve 167 (e.g., a check valve) may be included in the first replacement fluid port 124 and the arterial line 102.

[0115] refer to Figure 13 and Figure 23 ,pass Figure 13 Longitudinal sectional view of dialyzer 100 and Figure 23A partial longitudinal sectional perspective view of the first end cap 120 provides a clearer view of the flow path of blood (which, as described above, may be undiluted or diluted with a displacer) passing through the first end cap 120. The blood flows through the rotor supply tube 103 to the pump housing 130. A 90° bend at the end of the rotor supply tube 103 directs the blood to flow parallel to the longitudinal central axis Z of the dialyzer 100 at the center of the first end cap 120. From the outlet of the rotor supply tube 103, the blood is delivered to the center of the pump rotor 132 located within the pump housing 130.

[0116] Also refer to Figure 24 An exemplary pump rotor 132 includes a first plate 133, a disk 136, and a plurality of blades 135 (or blades) extending between the first plate 133 and the disk 136. According to some embodiments, the pump rotor 132 is a pump impeller comprising a radially pumping impeller having a hollow central volume region. Therefore, the illustrated pump rotor 132 may also be referred to as a pump impeller. The blades (or blades) of the pump impeller of the pump rotor 132 may be arranged such that they at least partially project radially or extend. In some cases, the blades are arranged to project or extend entirely radially. In some cases, the blades are arranged to project or extend partially radially and partially tangentially.

[0117] The first plate 133 is an annular ring defining a central aperture 134. In some embodiments, the first plate 133 is omitted, and the blade 135 extends from the disk 136 and terminates without the first plate 133. The disk 136 defines a central cavity 131 extending along the longitudinal central axis Z of the dialyzer 100. Figure 23 The disk 136 may include unencapsulated or encapsulated bipolar magnets (e.g., rare-earth magnets, ferrite ceramic magnets, and other suitable types of magnets). In the illustrated embodiment, the blade 135 is an arcuate member.

[0118] The rotation of pump rotor 132 causes blood to flow... Figure 13 and Figure 23 The flow is indicated by the large arrow. In some embodiments, the pump rotor 132 is driven during operation to rotate at a speed (revolutions per minute) in the range of 5,000 rpm to 25,000 rpm, or 5,000 rpm to 22,000 rpm, or 7,000 rpm to 20,000 rpm, or 9,000 rpm to 18,000 rpm, or 11,000 rpm to 16,000 rpm, or 12,000 rpm to 15,000 rpm, or 13,000 rpm to 14,000 rpm, but is not limited thereto.

[0119] In some embodiments, the height of the blade 135 (measured along the longitudinal central axis Z) is in the range of 2 mm to 10 mm, or 2 mm to 8 mm, or 2 mm to 6 mm, or 3 mm to 5 mm, or 3 mm to 4 mm, but is not limited thereto.

[0120] In some embodiments, the diameter of the outlet of the rotor supply pipe 103 is in the range of 5 mm to 10 mm, or 6 mm to 9 mm, or 7 mm to 8 mm, but is not limited thereto. In some embodiments, the diameter of the central hole 134 of the pump rotor 132 is in the range of 4 mm to 12 mm, or 5 mm to 11 mm, or 6 mm to 10 mm, or 7 mm to 9 mm. In some embodiments, the diameter of the central cavity 131 is in the range of 2 mm to 10 mm, or 3 mm to 9 mm, or 4 mm to 8 mm, or 5 mm to 7 mm, but is not limited thereto. Therefore, in some embodiments, the diameter of the central hole 134 of the pump rotor 132 is greater than, equal to, or less than the diameter of the outlet of the rotor supply pipe 103. Furthermore, in some embodiments, the diameter of the central cavity 131 of the pump rotor 132 is greater than, equal to, or less than the diameter of the outlet of the rotor supply pipe 103. Furthermore, in some embodiments, the diameter of the central hole 134 of the pump rotor 132 is greater than, equal to, or less than the diameter of the outlet of the rotor supply pipe 103.

[0121] In some embodiments, during operation (e.g., when the pump rotor 132 is suspended), the gap between the top surface of the first plate 133 and the opposing lower surface of the inner support plate 121 is in the range of 1 mm to 3 mm, or 2 mm to 3 mm, or 1.5 mm to 2.5 mm, or 1 mm to 5 mm, but is not limited thereto. Similarly, in some embodiments, during operation (e.g., when the pump rotor 132 is suspended), the gap between the bottom of the disk 136 and the opposing surface of the pump housing 130 is in the range of 1 mm to 3 mm, or 2 mm to 3 mm, or 1.5 mm to 2.5 mm, or 1 mm to 5 mm, but is not limited thereto. In some embodiments, during operation, the ratio of (i) the gap between the top surface of the first plate 133 and the opposing lower surface of the inner support plate 121 to (ii) the gap between the bottom of the disk 136 and the opposing surface of the pump housing 130 is in the range of 1.1:1.0 to 1.2:1.0, or 0.8:1.0 to 1.0:1.0, or 1.0:1.0 to 1.3:1.0, or 0.9:1.0 to 1.1:1.0, but is not limited thereto.

[0122] In some embodiments, the outer diameter of the disk 136 is in the range of 15 mm to 25 mm, or 17 mm to 22 mm, or 18 mm to 20 mm, but is not limited thereto. In some embodiments, the inner diameter of the cylindrical inner wall of the pump housing 130 is in the range of 15 mm to 25 mm, or 17 mm to 23 mm, or 18 mm to 22 mm, or 19 mm to 21 mm, but is not limited thereto. Therefore, in some embodiments, the radial clearance between the cylindrical outer wall of the pump rotor 132 and the cylindrical inner wall of the pump housing 130 is in the range of 0.3 mm to 1.1 mm, or 0.4 mm to 0.9 mm, or 0.5 mm to 0.8 mm, or 0.6 mm to 0.7 mm, but is not limited thereto.

[0123] Blood flows into pump rotor 132, through central hole 134, and radially outward from pump rotor 132 by the rotation of vanes 135. (See again) Figure 13 and 23 As blood normally flows radially away from the pump rotor 132, it enters an annular space 128 defined by the pump housing 130 and / or the arterial end cap 120. Within the annular space 128, the blood is forced to change direction by the inner wall of the pump housing 130 and flows parallel to the longitudinal axis Z of the dialyzer 100 toward the bundle of hollow fibers 114.

[0124] In some embodiments, the diameter of the annular space 128 is 10 mm to 17 mm, or 11 mm to 16 mm, 12 mm to 15 mm, or 13 mm to 15 mm, or 14 mm to 15 mm larger than the diameter of the cylindrical inner wall of the pump housing 130 (including the disk 136), but is not limited thereto.

[0125] The first end cap 120 includes an internal support plate 121. The rotor supply tube 103 may be attached to and / or supported by the internal support plate 121. The internal support plate 121 is also attached to a circumferential portion of the inner wall of the first end cap 120, defining a plurality of openings (e.g., slots, circular openings, etc.) 123 therebetween. The openings / slots 123 provide channels for blood to flow from the pump housing 130 to the hollow fiber bundle. In the illustrated embodiment, there are four arcuate slots 123 through which blood can flow. In some embodiments, there may be a single opening / slot 123, or two openings / slots 123, three openings / slots 123, four openings / slots 123, five openings / slots 123, six openings / slots 123, seven openings / slots 123, eight openings / slots 123, or more than eight openings / slots 123.

[0126] Due to the increased pressure generated by the rotating pump rotor 132, blood is forced through the internal space (or lumen) of each hollow fiber in the bundle of hollow fibers 114. Blood enters the fibers through openings exposed on the surface of the perfusion seal 115. Because the perfusion seal 115 is sealed relative to the arterial cap 120, the pressurized blood is forced through the lumen of the hollow fibers in the bundle of hollow fibers 114, through which the hollow fibers pass and are supported by the perfusion seal 115. In this example, the perfusion seal 115 is sealed relative to the arterial cap 120 by a gasket 170, which is axially (i.e., in the direction of the longitudinal axis Z) compressed between the outer periphery of the perfusion seal 115 and the inner wall of the arterial cap 120. A second gasket 171 serves a similar function relative to the venous cap 140 and the perfusion seal 116.

[0127] Dialysis occurs on the semi-permeable fiber membrane as blood flows axially through the lumen of the bundle of hollow fibers 114, with the dialysate flowing (countercurrently) in the space surrounding the fibers 114. Blood continues to flow within the hollow fibers 114, passing through the second perforation 116 in the venous end cap 140, and entering the internal space 146 in the upper cap 145 of the venous end cap 140.

[0128] Furthermore, when using dialyzer 100, the dialysate flows from venous end cap 140 to arterial end cap 120 along the outer surface of the hollow fibers 114, for example, within the space defined between the hollow fibers 114. If the dialysate flow rate is measured at various points along the radius of the cross-section transverse to the longitudinal axis Z, the measurements will show that, in many cases, the axial flow rate of the dialysate within the hollow fibers 114 is not entirely uniform. That is, in many cases, it can be observed that the dialysate flow rate is higher in the outer region of the bundle of hollow fibers 114 than in the inner region of the bundle of hollow fibers 114. In other words, more dialysate tends to flow through dialyzer 100 along the outer annular portion of the bundle of hollow fibers 114, rather than through the central portion of the bundle of hollow fibers 114.

[0129] Given the non-uniform flow rate of the dialysate as described above, the arterial end cap 120 is advantageously designed to guide blood flow through the bundle of hollow fibers 114 in a manner that enhances dialysis efficiency. For example, the arterial end cap 120 includes an arcuate groove 123 through which blood is guided to flow in the path into the bundle of hollow fibers 114. The radial position of the arcuate groove 123 is biased towards the outer annular portion of the bundle of hollow fibers 114 (compared to the central portion of the bundle of hollow fibers 114). Therefore, the arterial end cap 120 allows blood to flow through the outer annular portion of the bundle of hollow fibers 114 at a higher rate than the central portion of the bundle of hollow fibers 114, in a manner that advantageously matches the higher flow rate region of the dialysate. This matching of the flow rate distributions of blood and dialysate, compared to having different flow rate distributions, is beneficial for improving dialysis efficiency.

[0130] The arterial endcap 120 is also advantageously designed to reduce the likelihood of hemolysis (damage to red blood cells). As described above, blood leaving the rotor 132 flows radially from the blades 135 into the annular space 128. However, due to the rotation of the rotor 132, the blood within the annular space 128 also tends to flow in a generally circular manner (e.g., like a vortex). If blood is forced into the lumen of the hollow fiber 114 while still flowing in a generally circular manner, the resulting dynamic shear stress will tend to cause hemolysis. Fortunately, the internal support plate 121 of the arterial endcap 120 is designed to reduce the circular flow of blood, thereby reducing the likelihood of hemolysis. For example, the arcuate groove 123, through which the blood is guided in the path of the bundle entering the hollow fiber 114, reduces the circular flow of blood. Instead, the arcuate groove 123 directs the blood more axially toward the inlet into the lumen of the hollow fiber 114. Therefore, by reducing the circular flow of blood when it enters the lumen of the hollow fiber 114, the arcuate groove 123 of the internal support plate 121 reduces the possibility of dynamic shear stress on the blood and reduces the possibility of hemolysis.

[0131] As described above, the pump rotor 132 defines a central cavity 131. The central cavity 131 extends from the region of the blade 135 through the pump rotor 132 and continues through the disk 136. In other words, the central cavity 131 provides fluid communication between the region of the blade 135 and the gap existing between the cylindrical outer wall of the pump rotor 132 and the cylindrical inner wall of the pump housing 130. This fluid communication provided by the central cavity 131 reduces the likelihood of blood stagnation in the region within the pump housing 130. That is, the central cavity 131 facilitates the movement and outflow of blood in the gap between the cylindrical outer wall of the pump rotor 132 and the cylindrical inner wall of the pump housing 130. Therefore, due to the central cavity 131 of the pump rotor 132, the likelihood of thrombosis in the pump housing 130 is reduced.

[0132] Also refer to Figure 25 The alternative pump rotor 137 includes a first plate 138, a disk 143, and a plurality of blades 139 extending radially between the first plate 138 and the disk 143. The first plate 138 is annular and defines a central bore 141. The disk 143 may include unencased or encased bipolar magnets (e.g., rare-earth magnets, ferrite ceramic magnets, and other suitable types of magnets). In the illustrated embodiment, the blades 139 are linear elements.

[0133] According to some embodiments, the pump rotor 137 is a pump impeller that includes a radially pumping impeller having a hollow central volume region. Therefore, the illustrated pump rotor 137 can also be referred to as a pump impeller. The blades (or vanes) of the pump impeller of the pump rotor 137 can be arranged such that they at least partially project radially or extend. In some cases, the vanes are arranged to project or extend completely radially. In some cases, the vanes are arranged to project or extend partially radially and partially tangentially.

[0134] Blood flows toward pump rotor 137, through central bore 141, and is then forced radially outward from pump rotor 137 due to the rotation of vanes 139. As the blood flows radially away from pump rotor 137, it is forced to change direction by the inner wall of pump housing 130 and flow parallel to the longitudinal axis of dialyzer 100 (towards the hollow fiber bundle). The blood then flows through a groove 123 defined between the inner wall of internal support plate 121 and first end cap 120. Groove 123 provides a channel for blood to flow from pump housing 130 to hollow fiber bundle.

[0135] refer to Figures 27 to 29 The venous end cap 140 (or “second end cap 140”) is shown here, separate from the rest of the dialyzer 100, making the structural details of the second end cap 140 more visible.

[0136] As shown in the figure, for example... Figure 13 and Figure 14 As shown, blood that has passed through the fiber bundle 114 in the dialyzer 100 and entered the second end cap 140 leaves the top cap 145 via the blood outlet tube 105.

[0137] The second end cap 140 also includes an air purging element 144. The air purging element 144 may be located at the apex of the upper top cap 145. The air purging element 144 may be used for a variety of purposes, such as for purging air (exhausting) and as an inlet port (e.g., for sample extraction or drug administration). Figure 29 A cross-sectional view of another exemplary intravenous end cap 340 is shown, which differs from end cap 140 in that, in addition to an air purging element 344, end cap 340 includes an access port 380 (in this case, a needle-free inlet). Access port 380 can be used to administer medication or extract samples.

[0138] Blood enters the venous pressure detection chamber 142 (with a flexible membrane wall 162 on its exterior) from the blood outlet tube 105 via the venous pressure detection chamber inlet 142i. Blood exits the venous pressure detection chamber 142 via the venous pressure detection chamber outlet 142o. The flow of blood through the venous pressure detection chamber 142 allows the venous pressure transducer 252 of the blood therapy module 220 to... Figure 31 (As shown) Venous blood pressure is measured via membrane 162.

[0139] After leaving the venous pressure monitoring chamber 142, the blood then flows into the venous mixing chamber 164. The blood may pass through the venous mixing chamber 164 without post-dilution, or it may be mixed with a replacement fluid, for example, when the blood treatment system 1 is operating in post-dilution HDF mode.

[0140] When the replacement fluid is added to the intravenous mixing chamber (e.g., after HDF dilution), the replacement fluid is supplied from the second replacement fluid supply conduit 256 via the second replacement fluid inlet 148. Figure 31 (As shown in the diagram) Flows into the second end cap 140. The replacement fluid flows through the venous replacement supply line 166. Then, the replacement fluid passes through the check valve 168 and enters the venous mixing chamber 164. This flow of replacement fluid is via... Figure 15 A series of arrows are shown extending from the second replacement fluid inlet 148 to the outlet of the check valve 168. In the venous mixing chamber 164, the replacement fluid mixes with venous blood entering from the venous pressure detection chamber 142. The check valve 168 prevents blood from flowing into the venous replacement fluid supply line 166 and the second replacement fluid inlet 148. This prevents the second replacement fluid supply line 256 from being contaminated with blood.

[0141] Blood (whether diluted or not) enters the venous blood line 104 from the venous mixing chamber 164, which in turn returns the dialyzed blood to the patient.

[0142] The second end cap 140 also includes a dialysate inlet 149. Dialysate flows from the dialysate inlet 149 to the peripheral inner wall region of the second end cap 140 through a dialysate supply tube 150.

[0143] The flow path of the dialysate from the dialysate supply line 257 to the dialysate outlet line (or waste dialysate line) 255 is as follows: Figures 17 to 19 As shown in the diagram. The blood therapy module 220 is actuated to: a) supply dialysate to the dialysate supply line 257 (in... Figure 31 (a) fluid-tightly engages with dialysate inlet 149, and (b) fluid-tightly engages waste dialysate conduit 255 with waste dialysate outlet 125. Dialysate flow then begins as dialysate flows through dialysate supply tubing 150 into the space between venous end cap 140 and filling seal 116. Dialysate flows axially through this space through filling seal 116 and radially inward through opening 118 between axially extending fingers 174 of intermediate housing portion 112. The ends of fingers 174 are embedded in and support filling seal 116. The dialysate path is isolated from blood flow in venous end cap 140 by gasket 171.

[0144] The radial inflow of dialysate through opening 118 (using fingers 174 to aid in dialysate flow distribution) causes the dialysate to be distributed circumferentially in a ring-like manner as it flows radially into the space between the hollow fibers 114. This circumferentially concentrated dialysate flow is adapted to or synchronized with the flow of blood through the lumen of the hollow fibers 114, as blood enters the hollow fibers 114 through openings / grooves 123 located peripherally on the first end cap 120. Therefore, the dialyzer 100 is designed to match the peak flow concentrations of dialysate and blood within the region of the hollow fibers 114. This matching of blood and dialysate flow concentrations improves the hemotherapy efficiency of the dialyzer 100.

[0145] After passing through opening 118, the dialysate flows between hollow fibers 114 and continues axially downward until it reaches the arterial end cap 120. Since the perfusion seal 115 prevents further axial flow between the fibers 114, the dialysate flows radially outward through opening 117 between the intercalation of the intermediate housing portion 112 and the fingers 173 supporting the perfusion seal 115. The dialysate path is isolated from the blood volume in the arterial end cap 120 by a gasket 170. The dialysate then flows into the space between the arterial end cap 120 and the perfusion seal 115. The dialysate then enters the waste dialysate outlet pipe 126 via the waste dialysate inlet 127. The waste dialysate pipe 126 then delivers the dialysate to the dialysate outlet, where it flows into the waste dialysate conduit 255 of the blood therapy module 220 (in...). Figures 31 to 33 (as shown in the image).

[0146] refer to Figure 30 and Figure 31 The treatment module 220 defines a first complementary-shaped slot 222 and a second complementary-shaped slot 224, which configure the treatment module 220 to be compatible with the first protrusion 106 and the second protrusion 108 of the dialyzer 100 (e.g., Figure 2 , Figure 10 and Figure 17 The treatment module 220 is slidably coupled. The treatment module 220 also includes an arterial line clamp 242 and a venous line clamp 244. Clamps 242 and 244 are used to completely or completely restrict the flow of blood within the arterial line 102 and / or the venous line 104 (e.g., in an open / close manner), or to regulate the flow of blood through the arterial line 102 and / or the venous line 104 (e.g., the clamps have a range of partially restrictive settings).

[0147] The treatment module 220 also includes a tubing connection module 240 configured to releasably receive a portion of the arterial line 102 and / or a portion of the venous line 104. The tubing connection module 240 may include means for performing functions such as flow rate detection and bubble detection. Specifically, the tubing connection module 240 may include sensors for detecting, for example, the flow rate of blood within the arterial line 102 and / or the venous line 104, and / or for detecting air bubbles (e.g., air bubbles) in the blood within the arterial line 102 and / or the venous line 104. Flow rate detection and / or bubble detection may be performed using sensors such as ultrasonic sensors, optical sensors, or other suitable types of sensors.

[0148] Treatment module 220 also includes pump drive unit 230. Pump drive unit 230 is configured to releasably receive the pump housing 130 of dialyzer 100 when dialyzer 100 is coupled to treatment module 220. Figure 8 , Figure 9 , Figure 13 and Figure 15 (As shown in the diagram). During the operation of the treatment module 220, via the blood therapy machine control console 210 (in... Figure 1 The control system (shown in the diagram) dynamically excites one or more coils within the pump drive unit 230. The excitation of these coils generates a dynamic magnetic field (a moving or modulated magnetic field) that causes the magnetic pump rotor (e.g., rotor 132 or rotor 137) to levitate without contacting the walls of the pump housing 130 and rotate at the desired speed. Alternatively, in some embodiments, mechanical coupling may be used to couple the pump drive unit to the pump rotor within the dialyzer.

[0149] The pump drive unit 230 is combined with the control system of the blood therapy machine control console 210 (in Figure 1 (As shown in the diagram) It can also be used to monitor various states of the dialyzer 100. For example, it can detect whether the pump housing 130 of the dialyzer 100 is in an operating position relative to the pump drive unit 230. Additionally, the presence of air in the pump housing 130 can be detected. If air is detected within the pump housing 130, a displacement medium can be added via the first displacement fluid port 124 to infuse the magnetic pump rotor. Blockages within the dialyzer 100 can also be detected by the pump drive unit 230 in conjunction with its control system.

[0150] Treatment module 220 also includes a pressure measuring device coupled to dialyzer 100 to measure arterial pressure detection chamber 122 and venous pressure detection chamber 142 (in Figure 8 , Figure 11 , Figure 12 , Figure 18 and Figure 19The pressure in the diagram is shown. Furthermore, the treatment module 220 includes conduits for supplying replacement fluid (via replacement fluid ports 124 and 148) to the dialyzer 100 and for delivering dialysate (via dialysate ports 125 and 149) to or from the dialyzer 100. These pressure measuring devices and conduits can be controlled by the treatment module 220 to extend and engage with the dialyzer 100, and retract and disengage from the dialyzer 100.

[0151] exist Figure 30 In the middle, the pressure measuring device and pipeline retract and are covered by the first gate 246 and the second gate 248. Figure 31 In the middle stage, doors 246 and 248 are opened, and the pressure measuring device and tubing are extended (as they are to engage with the dialyzer 100). When closed, doors 246 and 248 allow for convenient wiping to clean the outer surface of the treatment module 220. Additionally, when the pressure measuring device and tubing are retracted inside the treatment module 220 (and doors 246 and 248 are closed), the pressure measuring device and tubing can be automatically cleaned and prepared for later use while they are inside the treatment module 220.

[0152] exist Figure 31 In this configuration, doors 246 and 248 are in their open positions, and pressure measuring devices and tubing extend to their operational positions (as if dialyzer 100 were coupled to treatment module 220). For example, a first pressure transducer 250 extends to engage with the flexible membrane wall of arterial pressure detection chamber 122 of dialyzer 100, and a second pressure transducer 252 extends to engage with the flexible membrane wall of venous pressure detection chamber 142 of dialyzer 100.

[0153] Furthermore, the treatment module 220 includes two pairs of conduits that can be automatically coupled to the dialyzer 100 to facilitate the flow of fluids such as replacement material and / or dialysate between the dialyzer 100 and the treatment module 220. For example, the first pair of conduits (first replacement material supply conduit 254 and dialysate outlet conduit 255) are positioned to couple to the first replacement material port 124 and dialysate outlet 125 located on the first end cap 120 of the dialyzer 100, respectively. Additionally, the second pair of conduits (second replacement material supply conduit 256 and dialysate supply conduit 257) are positioned to couple to the second replacement material port 148 and dialysate inlet 149 located on the second end cap 140 of the dialyzer 100, respectively. The extension and retraction of conduits 254 to 257 and pressure measurement transducers 250 and 252 can be controlled by the control system of the blood therapy machine 200. Figure 1 ).

[0154] refer to Figures 32 to 34A separate view is provided showing more details of how the first end cap 120 engages with the first pressure transducer 250, the first displacement agent supply line 254, and the dialysate outlet line 255. It should be understood that the relative arrangement of the second end cap 140 with respect to the second pressure transducer 252, the second displacement agent supply line 256, and the dialysate supply line 257 is similar.

[0155] The face of the first pressure transducer 250 (when extended, such as...) Figure 24 (As shown) A flexible membrane 122m abuts against the outer wall of the arterial pressure detection chamber 122. A first replacement material supply conduit 254 (when extended, as...) Figure 24 (As shown) is fluidly coupled to the first replacement fluid port 124 in a liquid-tight manner. The dialysate outlet conduit 255 (when extended, as...) Figure 24 (As shown) is fluidly coupled to the dialysate outlet 125 in a liquid-tight manner.

[0156] To provide an effective engagement between the flexible membrane 122m and the first pressure transducer 250, the arterial pressure detection chamber 122 is pressurized before the first pressure transducer 250 extends to contact the flexible membrane 122m. When the arterial pressure detection chamber 122 is pressurized, the flexible membrane 122m bulges outward to present a convex surface to the first pressure transducer 250. Then, as the flexible membrane 122m bulges outward, the first pressure transducer 250 extends to abut against the flexible membrane 122m to seal the engagement between them. This technique, for example, can help establish a strong coupling adhesion between the first pressure transducer 250 and the flexible membrane 122m by reducing the possibility of cavitation therebetween. In some embodiments, a negative pressure (vacuum) can be applied to generate or enhance the coupling adhesion between the first pressure transducer 250 and the flexible membrane 122m.

[0157] Figure 35 Another exemplary blood therapy module 1220 and dialyzer 1100 are shown. This arrangement differs from that of module 220 and dialyzer 100 in that the dialysate port and replacement port, as well as the pressure chamber and membrane, are located within the arterial end cap. Therefore, the blood therapy module 1220 engages only the arterial end cap 1120 to supply fresh dialysate, receive waste dialysate, supply pre-diluted and post-diluted replacement fluid, and monitor arterial and venous pressure. In this arrangement, a pair of tubes 1190 are provided to deliver fresh dialysate and post-diluted replacement fluid from the arterial end cap 1120 to the venous end cap 1140.

[0158] Figure 36 This is a perspective view of an alternative first (arterial) end cap 520 shown in a partial longitudinal sectional view. For example, end cap 520 can be used with dialyzer 100 as an alternative to end cap 120.

[0159] The incoming blood flows toward the pump housing 530 through the rotor supply tube 503, supported by the internal support plate 521. A 90° bend at the end of the rotor supply tube 503 directs the blood to change direction and flow parallel to the longitudinal central axis of the dialyzer 100 at the center of the first end cap 520. The blood is delivered from the outlet of the rotor supply tube 503 to the center of the pump rotor 532 located within the pump housing 530. The blood exits the pump rotor 532 radially into an annular space 528, which circumferentially surrounds the portion of the rotor 532 including the blades 535. The annular space 528 is shaped to axially guide the blood toward the bundle of hollow fibers. The annular space 528 is partially defined by an annular concave wall surface of the housing 530, which faces the bundle of hollow fibers. After changing from radial to longitudinal flow in the annular space 528, the blood then passes through one or more openings 523 defined in the internal support plate 521 and continues to flow toward the bundle of hollow fibers. In some embodiments, opening 523 is a slot (e.g., a linear or arcuate slot). Any number of openings 523 may be included, such as one, two, three, four, five, six, seven, eight, or more than eight.

[0160] The pump rotor 532 includes a first end 537 and a second end 538 located at opposite ends of the pump rotor 532. The first end 537 accommodates or has one or more magnets, such as a magnetic disk 536, connected thereto. The second end 538 includes a first plate 533 and a plurality of blades 535 extending between the first plate 533 and the magnetic disk 536. The first end 537 has a smaller diameter than the second end 538.

[0161] According to some embodiments, pump rotor 532 is a pump impeller comprising a radially pumping impeller having a hollow central volume region. Therefore, the illustrated pump rotor 532 may also be referred to as a pump impeller. The blades 535 of the impeller (second end 538) of pump rotor 532 may be arranged such that they at least partially project radially or extend. In some cases, the blades are arranged to project or extend entirely radially. In some cases, the blades are arranged to project or extend partially radially and partially tangentially. First plate 533 is an annular ring defining a central bore 534. Disk 536 defines a central cavity 531 extending along the longitudinal central axis Z of dialyzer 100. Disk 536 may include one or more enclosed or unenclosed bipolar magnets (e.g., rare-earth magnets, ceramic ferrite magnets, and other suitable types of magnets). In the illustrated embodiment, blades 535 are arcuate, but in some embodiments, blades 535 may be linear.

[0162] In some embodiments, the components of end cap 520 may have the same physical dimensions and dimensional relationships as described above for the components of reference end cap 120. However, end cap 520 differs from end cap 120 in at least the following aspects: The outer edge of blade 535 is not parallel to the central axis. Instead, an acute angle is defined between the outer edge of blade 535 and the central axis. In some embodiments, the acute angle is in the range of 0° to 60°, or 0° to 45°, or 5° to 40°, or 10° to 35°, or 20° to 35°, or 25° to 35°, or 30° to 45°, but is not limited thereto. Furthermore, in some embodiments, the height of blade 535 is less than the height of blade 135. For example, in some embodiments, the height of blade 535 (measured along the longitudinal central axis Z) is in the range of 1 mm to 8 mm, or 1 mm to 6 mm, or 1 mm to 5 mm, or 1 mm to 4 mm, or 1 mm to 3 mm, or 2 mm to 3 mm, but is not limited thereto. Furthermore, the annular space 528 differs from the annular space 128 in shape. For example, the inner surface of the housing defining the lower wall of the annular space 528 is concave (curved downwards), while the lower surface of the annular space 128 is planar or curved upwards. The shape of the annular space 528 promotes the formation of vortices in the flow radially away from the pump rotor 532 and facilitates the transition (redirection) of the flow toward the upward axial direction.

[0163] These physical features of the end cap 520 and its pump rotor 532 are designed to maximize the axial thrust of blood flow and stabilize the pump rotor 532 during operation. Essentially, the pump rotor 532 and the annular space 528 redirect blood flow by 180° instead of 90°. In some embodiments, blood is axially introduced into the “top” of the pump rotor 532 and delivered to the “bottom” of the rotor 532.

[0164] Blood exits the end cap 520 through one or more openings 523 in a circular pattern concentric with the central hole 534. The one or more openings 523 can be a plurality of holes arranged in a symmetrical circular pattern, or a slit in the shape of one or more circular / arc segments. Therefore, no eccentric force acts on the pump rotor 532 (unlike most centrifugal pumps with tangential outlets). Consequently, the pump rotor 532 is more stable during operation (e.g., with a significantly reduced tilting moment), and the dimensional clearance between it and the surrounding housing surface remains within tolerances. Advantageously, because the pump rotor 532 is more stable during operation, the magnetic field strength required to suspend and drive the pump rotor 532 is reduced. Therefore, for example, in some embodiments, lower-cost hard ferrite magnets can be used, thereby significantly reducing the cost of the pump rotor 532.

[0165] The shape of the annular space 528 facilitates the transition (redirection) of blood flow from the radial direction to the upward axial direction. The upward blood flow from the annular space 528 is essentially concentrated around the periphery or circumference of the outlet of the annular space 528. This concentration of blood flow also advantageously matches the location of the opening 523 (which in turn matches the outer portion of the bundle of hollow fibers). Furthermore, as referenced above… Figures 17 to 19 As the dialysate flows radially into the space between the hollow fibers 114, the dialysate flow is concentrated in a circumferential, annular manner. The peripherally concentrated dialysate flow matches or coincides with the peripherally concentrated blood flow passing through the inner lumen of the hollow fibers 114. Therefore, the dialyzer 100 is advantageously designed so that the highest flow rates of dialysate and blood are concentrated in the same region, matching or adapting to each other. This matching of the concentrated blood and dialysate flows improves the hemotherapy efficiency of the dialyzer 100.

[0166] Although some embodiments have been described, other embodiments are possible and are within the scope of this disclosure.

[0167] Although a system with HDF functionality has been described, some embodiments omit the replacement port. Such a machine can perform hemodialysis but does not include HDF functionality. For example, it may be configured similar to [other systems] except for the lack of HDF functionality. Figure 1 The dialyzer 2100 of the blood therapy system dialyzer Figure 37 – Figure 39 As shown in the figure. The housing 2110 of the dialyzer 2100 includes a first end cap 2120, a second end cap 2140, and an intermediate housing portion 2112 extending between the first end cap 2120 and the second end cap 2140. The intermediate housing portion 2112 contains most of the length of a bundle of hollow fibers 2114.

[0168] The first end cap 2120 includes a pump housing 2130. A rotatable centrifugal pump rotor (not visible) is located within the pump housing 2130. As further described herein, the pump rotor is connected to the pump drive unit of the treatment module 220 (e.g., as...). Figure 2 and Figure 3 (As shown) is engaged and controlled. That is, during use, the pump rotor can be levitated and rotated by a magnetic field emitted from the pump drive unit.

[0169] Housing 2110 defines one or more pressure sensing chambers. The illustrated embodiment includes an arterial pressure sensing chamber 2122 and a venous pressure sensing chamber 2142. Arterial pressure sensing chamber 2122 is located before the pump rotor. That is, arterial pressure sensing chamber 2122 is arranged to facilitate measurement of arterial pressure before the pump. Additionally or alternatively, in some embodiments, pressure can be measured after the pump (but before the hollow fiber). Both pressure sensing chambers 2122 and 2142 are configured to engage with corresponding pressure transducers in the treatment module 220.

[0170] Dialyzer 2100 is configured to receive dialysate and guide its flow through housing 2110. For example, in the illustrated embodiment, a second end cap 2140 defines a dialysate inlet 2149, and a first end cap 2120 defines a dialysate outlet 2125. Dialysate flows into the second end cap 2140 via the dialysate inlet 2149 and then into an intermediate housing portion 2112 comprising a bundle of hollow fibers 2114. Dialysate flows through the intermediate housing portion 2112 via a space defined between the outer diameters of the fibers of the bundle of hollow fibers 2114. In other words, as blood flows within the lumen of the fibers of the bundle of hollow fibers 2114, the dialysate flows along the outer surface of the fibers. The semi-permeable walls of the fibers of the bundle of hollow fibers 2114 separate the dialysate from the blood. The dialysate flows out of the intermediate housing portion 2112 and into the first end cap 2120. The dialysate exits the first end cap 2120 via the dialysate outlet 2125.

[0171] refer to Figure 40 and Figure 41 An alternative second (venous) end cap 600 can be used with any dialyzer described herein. The venous end cap 600 is configured with specific features to facilitate the separation of gases such as air from the extracorporeal circuit during infusion and use. The venous end cap 600 includes a spiral inlet 610 (or spiral cavity 610), an outlet 620, an inclined guide 630, a top cap 640, an air scavenger 650, and a chamber 660. Figure 41 In this diagram, the top cover 640 and air purging member 650 are not shown to provide better visibility of the internal structure of the chamber 660. The upper portion of the venous end cap 600 includes the top cover 640 and the attached air purging member 650. The lower portion or bottom of the venous end cap 600 defines a spiral inlet 610 and its outlet 620, and includes an inclined guide 630. The spiral inlet 610 and the inclined guide 630 may be integrally formed with the lower portion of the venous end cap 600. The outlet of the spiral inlet 610 is located between the upper portion of the venous end cap 600 and the outlet 620 of the chamber 660.

[0172] In use, blood exits the lumen of the hollow fiber and flows into the chamber 660 via an inlet to the spiral inlet 610 and through the spiral inlet 610 itself. In other words, the spiral inlet 610 provides fluid communication between the chamber 660 and its external region. The inlet to the spiral inlet 610 is located on the underside of the bottom of the venous end cap 600. The inlet to the spiral inlet 610 has a larger area than the transverse cross-section of the spiral inlet 610. The outlet of the spiral inlet 610 is located on the upper side of the bottom. The spiral inlet 610 extends from the lower part of the venous end cap 600 and spirals vertically toward the upper part of the venous end cap 600 (towards the top cap 640). The spiral inlet 610 is configured such that the blood entering the chamber flows substantially horizontally (i.e., transverse to the longitudinal axis of the dialyzer). The exit of the spiral inlet 610 (i.e., the location where the spiral inlet 610 terminates within the chamber 660) is close to the outer peripheral wall of the chamber 660. In other words, the exit of the spiral inlet 610 is offset from the central axis of the dialyzer and the central axis of the venous cap 600 itself. Therefore, blood flowing into the chamber 660 may tend to impact the outer peripheral wall of the chamber 660, which will create a spiral flow path for the blood.

[0173] The inclined guide fluid 630 is located near the outlet of the spiral inlet 610, such that blood leaving the spiral inlet 610 tends to impact the inclined guide fluid 630 and deflect upward toward the top cover 640, which is a rigid part of the housing, thus defining a fixed shape for the upper part of the chamber 660. The impact surface of the inclined guide fluid 630 can be at an acute angle relative to the substantially horizontal blood flow direction as blood leaves the spiral inlet 610. For example, in some embodiments, the angle of the inclined guide fluid 630 relative to the horizontal and / or relative to the central longitudinal axis of the dialyzer and venous end cap 600 is in the range of 10° to 70°, or 20° to 60°, or 30° to 50°, or 30° to 40°, but is not limited thereto.

[0174] The air purging element 650 allows air and other gases to exit the venous end cap 600 while preventing fluids such as blood from leaving through it. The air purging element 650 can also be used as an inlet port. That is, the air purging element 650 can be configured for uses such as sample extraction and drug (e.g., heparin) administration.

[0175] To function optimally as an air separator during use, air needs to be substantially removed from the venous endcap 600 by perfusion before initiating blood therapy. That is, sufficient air needs to be removed from the chamber 660 during the perfusion phase so that the chamber 660 can optimally and effectively separate air subsequently during blood therapy. During perfusion, the aim is to flush the air from the chamber 660 substantially out of the chamber 660 by the perfusion solution. The velocity and directional flow generated by the structure of the venous endcap 600 enhance the ability of the perfusion solution to remove air from the chamber 660 (e.g., by flushing air out through a flushing port located on the blood therapy machine). Alternatively, air retained in the chamber 660 can also be manually removed via the air purging device 650 by connecting a syringe to the air purging device 650.

[0176] During use, the flow velocity generated by the structure of the venous end cap 600 poses a challenge to air separation because air in the blood needs time to be affected by gravity and may still remain in the blood. The structure of the venous end cap 600 induces a circular spiral flow, which can slow down the blood flow. Therefore, air tends to migrate towards the center of the spiral flow, where the velocity is lowest, and the effects of gravity have time to act on the air, allowing the air to separate from the blood and collect at the top of the cap 640.

[0177] Although the structure of the venous end cap 600 for degassing fluid has been described above in the context of a dialyzer end cap, it should be understood that the degassing structure can also be used in conjunction with various other types of devices, or integrated into itself as a degassing device. That is, the degassing structure for the venous end cap 600 can be part of a degassing chamber that can be implemented in various suitable embodiments. Furthermore, although the venous end cap 600 is primarily intended for degassing blood, perfusion solutions, or other medical fluids, it should be understood that the degassing structure for the venous end cap 600 can also be implemented in other embodiments for degassing other types of fluids.

[0178] refer to Figures 42 to 44 Another alternative second (venous) end cap 700 can be used with any dialyzer described herein. The venous end cap 700 is configured with specific features to facilitate the separation of gases such as air from the extracorporeal circuit during perfusion and use.

[0179] The venous end cap 700 includes an upper portion or top, which includes a top cap 710 and an attached air purging element 730 (in...). Figure 43 As shown in, but in Figure 42 and 44 (Not shown in the image). The venous end cap 700 includes a lower portion or bottom, which includes an inlet channel 740 and defines an outlet chamber 750. Figure 44 A chamber 720 is defined between the upper and lower portions of the venous cap 700.

[0180] The inlet channel member 740 includes a protrusion that extends axially from the bottom of the venous end cap 700 along the central axis (e.g., longitudinal axis) of the venous end cap 700 (and the entire dialyzer). The inlet channel member 740 may be integrally formed with the lower portion of the venous end cap 700. The outlet of the inlet channel member 740 is at the end of the protrusion, which rises above the chamber outlet 750 and above the intermediate height of the chamber 720. The outlet of the inlet channel member 740 is radially offset from the central axis (e.g., longitudinal axis) of the venous end cap 700 (and the entire dialyzer). The top cap 710 is the rigid upper portion of the housing, thereby defining a fixed shape for the upper portion of the chamber 720.

[0181] After being processed through a hollow fiber membrane, blood enters the chamber 720 of the venous end cap 700 through an inlet channel 740 formed in the axial center of the venous end cap 700. The outlet end of the inlet channel 740 is configured in a spiral shape (e.g., having an acute-angled slope relative to the central axis along which blood exiting the inlet channel 740 will flow). Therefore, the outlet end at the end of the inlet channel 740 is configured to provide a spiral component to the blood flow path as it leaves the inlet channel 740 and enters the chamber 720. After overflowing from the outlet end of the inlet channel 740, blood enters the chamber 720. The blood can be degassed by gravity (air bubbles will tend to rise relative to the blood and separate from it) as the blood flows in a thin layer and spirally from the end of the inlet channel 740 into the chamber 720 and toward the chamber outlet 750.

[0182] Although the intermediate inlet channel 740 in the illustrated embodiment includes only one helical channel outlet (entering chamber 720), in some embodiments, the inlet channel 740 may also include multiple helical channel outlets. In some of these embodiments, the multiple helical channel outlets may be symmetrically or uniformly distributed on the venous endcap 700 to minimize turbulence in the blood and symmetrically balance the flow within chamber 720.

[0183] Although the structure of the venous end cap 700 for degassing fluid has been described above in the context of a dialyzer end cap, it should be understood that the degassing structure can be used in conjunction with various other types of devices or integrated into itself as a degassing device. That is, the degassing structure for the venous end cap 700 can be part of a degassing chamber that can be implemented in various suitable embodiments. Furthermore, although the venous end cap 700 is primarily intended for degassing blood, perfusion solutions, or other medical fluids, it should be understood that the degassing structure for the venous end cap 700 can be implemented in other embodiments to degas other types of fluids.

[0184] refer to Figures 45 to 47 Another alternative second (venous) end cap 800 can be used with any dialyzer described herein. The venous end cap 800 is configured with specific features to facilitate the separation and collection of gases, such as air, from the extracorporeal circuit. For example, the venous end cap 800 includes a reconfigurable Popper cap, as further described below.

[0185] The venous end cap 800 includes one or more peripheral inlets 810 (or multiple peripheral inlets 810), an outlet 820, a reconfigurable top cap 840 (or a flexible top cap), an air purging element 850, and a chamber 860. Figure 47 The top cover 840 and air purging component 850 are not shown in the diagram to provide better visibility of the internal structure of the chamber 860. Figure 45 In this configuration, the reconfigurable top cover 840 is in a first, inverted arrangement, such that the chamber 860 is essentially nonexistent or only minimally present. Figure 46 In the second, dome configuration, the reconfigurable top cover 840 defines the chamber 860. Compared to the first configuration, the chamber 860 is larger when the reconfigurable top cover 840 is in the second configuration.

[0186] One or more peripheral inlets 810 are channels that allow liquid drained from the hollow fibers of the dialyzer to enter chamber 860. After entering chamber 860, the liquid remains in chamber 860 for a period of time and then exits chamber 860 via outlet 820. Outlet 820 is located in the lower sidewall of the housing and is lower than the height of the one or more peripheral inlets 810. In other words, when the reconfigurable top cover 840 is in the second, dome configuration, outlet 820 is on the opposite side of the one or more peripheral inlets 810 compared to the reconfigurable top cover 840.

[0187] In some embodiments, the outlet 820 is located in other locations. For example, in some embodiments, the outlet 820 is positioned at the center and bottom of the concave lower portion of the chamber 860, such as... Figure 47As shown by an exit 820'. In this location, exit 820' is surrounded by one or more peripheral entrances 810 and is equidistant from each of the one or more peripheral entrances 810. In some embodiments, multiple exits are included. For example, in some embodiments, exit 820 and exit 820' are each included in a single embodiment.

[0188] In some embodiments, a plurality of peripheral inlets 810 spaced apart from each other (e.g., six in the illustrated embodiment) surround the periphery of the chamber 860, thereby slowing the velocity of fluid (e.g., perfusion solution, blood, etc.) entering the chamber 860. By maintaining a low fluid flow velocity in the chamber 860, more time is allowed for air to rise in the fluid due to gravity (i.e., separate from the fluid). However, using this low-velocity method tends to make it more difficult to flush air out of the conventional chamber in the conventional endcap during the perfusion phase. The specific Popper cap (i.e., reconfigurable top cap 840) of the venous endcap 800 helps to mitigate this problem.

[0189] The reconfigurable top cover 840 (or flexible top cover 840) is a hemispherical component made of a semi-flexible material. The natural, least-stress configuration of the reconfigurable top cover 840 is... Figure 46 The shape shown (dome shape, dome-shaped configuration, or second configuration). The second configuration (dome shape) of the reconfigurable cover 840 is more stable than the first configuration (inverted configuration). However, the reconfigurable cover 840 will also maintain its... Figure 45 The inverted configuration is shown. The inverted configuration is the initial configuration of the reconfigurable cap 840 (i.e., the configuration of the reconfigurable cap 840 before filling or use). In response to pressurization within the chamber 860, the reconfigurable cap 840 (or flexible cap 840) will be reconfigured from the first configuration (inverted configuration) to the second configuration (dome configuration).

[0190] During infusion, as liquid passes through one or more inlets 810, the liquid applies force to the inner surface of the inverted reconfigurable top cover 840. The reconfigurable top cover 840 will begin to deflect upward in response to the force of the liquid, and the chamber 860 will thus begin to form. When the reconfigurable top cover 840 has deflected upward to a threshold degree, the reconfigurable top cover 840 will naturally tend toward complete formation of the chamber 860. Figure 46 The dome configuration shown may vary or pop up. Advantageously, because chamber 860 is essentially absent or only minimally present during initial perfusion, there is essentially no air that needs to be flushed out during the liquid perfusion process. However, after chamber 860 has been formed, it is used to separate air / gas from the blood during use.

[0191] Although the structure of a venous end cap 800 for degassing fluid has been described above in the context of a dialyzer end cap, it should be understood that the degassing structure can be used in conjunction with various other types of devices or incorporated into itself as a degassing device. That is, the degassing structure for the venous end cap 800 can be part of a degassing chamber that can be implemented in various suitable embodiments. Furthermore, although the venous end cap 800 is primarily used for degassing blood, perfusion solutions, or other medical fluids, it should be understood that the degassing structure for the venous end cap 800 can be implemented in other embodiments to degas other types of fluids.

[0192] The above describes various types of dialyzer venous end caps (e.g., venous end cap 600, venous end cap 700, and venous end cap 800) having structures for degassing the liquid. It should be understood that features of the various venous end caps 600, 700, and / or 800 can be mixed, combined, added, substituted for other features, etc., to create hybrid designs within the scope of this disclosure. For example, although venous end cap 800 is described as having a reconfigurable top cap 840, in some embodiments, a rigid / fixed top cap (e.g., top cap 640 or top cap 710) may also replace the reconfigurable top cap 840. Conversely, although venous end caps 600 and 700 are described as having rigid / fixed top caps, in some embodiments, a reconfigurable top cap (e.g., reconfigurable top cap 840) may replace the rigid / fixed top cap. The inlet and / or outlet configurations and / or locations of the various venous end caps 600, 700, and / or 800 can also be substituted or added in various designs. Through these examples, it should be understood that all possible hybrid designs using the features of various vein endcaps 600, 700 and / or 800 are conceived and are within the scope of this disclosure.

[0193] The degassing chamber described herein is designed to separate gases (e.g., air) from a liquid (e.g., blood) by promoting the natural upward movement of gases with a density lower than that of the liquid towards the top cover of the degassing chamber. Therefore, the top cover can be said to be or include the upper part of the degassing chamber. The end of the degassing chamber opposite the top cover can be referred to as the lower part or bottom, or as being located below the top cover. Therefore, in the context of the degassing chamber described herein, terms such as above, below, upper, lower, top, and bottom can be used to define specific portions, locations, or orientations. Additionally, the dialyzer described herein can be configured to attach to a blood therapy machine (e.g., therapy module 220) such that the second end cap (venous end cap) is above the first end cap (arterial end cap).

[0194] The above-described devices and methods are examples of the innovations disclosed herein. As described below, but not limited thereto, the scope of this disclosure also covers other embodiments and alternative forms.

[0195] Although clips 242 and 244 are described as acting as on / off valves, in some embodiments, clips 242 and 244 are used to variably regulate the flow of blood through arterial line 102 and / or venous line 104 (e.g., including the range of partially restricted clip settings).

[0196] Although the first end cap 120 and the second end cap 140 have been described as having ports and pressure chambers with a particular arrangement, in some embodiments the end caps have ports and pressure chambers with other arrangements.

[0197] Although the treatment module 220 is described as extending from the blood therapy machine control console 210 via an adjustable arm 280, in some embodiments, the treatment module 220 is attached to the blood therapy machine control console 210 via a pivot mechanism, directly attached thereto or integrated therein. In some such cases, the length of the arterial line 102 and the venous line 102 may be greater than one meter.

[0198] Although dialyzer 100 has been described as having integrated pressure sensing chambers 122 and 142, in some embodiments, arterial and / or venous pressure sensing is performed at locations along arterial lines 102 and / or venous lines 104, rather than at dialyzer 100. In this case, pressure sensing chambers 122 and / or 142 are removed from dialyzer 100 (but dialyzer 100 may still include an integrated magnetic pump rotor, such as rotor 132 or rotor 137).

[0199] Although dialyzer 100 has been described as having an integrated magnetic pump rotor (e.g., rotor 132 or rotor 137), in some embodiments, a peristaltic pump acting on the arterial line 102 is alternatively included. In this case, the rotor is removed from dialyzer 100 (although dialyzer 100 may still include integrated pressure sensing chambers 122 and / or 142). Some examples utilize other blood pumping mechanisms (e.g., diaphragm pumps, screw pumps, piston pumps, peristaltic pumps, etc.).

[0200] Although components of dialyzer 100, such as magnetic pump rotors (e.g., rotor 132 or rotor 137) and pressure sensing chambers 122 and 142, have been described as being integrated into end caps 120 and 140 of dialyzer 100, in some embodiments one or more such components may also be integrated into portions of dialyzer 100 other than end caps 120 and 140.

[0201] Although the blood flow path through dialyzer 100 is illustrated as extending upward from the first end cap 120 at the bottom of dialyzer 100 to the second end cap 140 at the top of dialyzer 100, in some embodiments, the blood flow path through dialyzer 100 may extend downward from the second end cap 140 at the top of dialyzer 100 to the first end cap 120 at the bottom of dialyzer 100. In this case, in some embodiments, an integrated magnetic pump rotor may be located in the second end cap 140 at the top of dialyzer 100.

[0202] While some examples include a treatment module 220 extending from the blood therapy machine console 210 via arm 280, it should be understood that other examples integrate these components as a single unit within a common housing. Furthermore, some examples have treatment modules that are not mechanically supported by the console. For example, some have treatment modules that are mounted to another structure (e.g., a wall or wall bracket or floor bracket) or placed on a surface such as a table or desk. Such examples may include flexible fluid lines and cables between the module and the console for transmitting fluid and electrical / signal signals. Other examples have treatment modules that can receive power independently from the console and / or have a wireless communication channel with the console.

[0203] Although the degassing chamber has been described in the context of the venous end cap of a dialyzer, the concept of a degassing chamber can also be implemented in the context of a stand-alone medical fluid degassing chamber device, or as part of any other suitable fluid handling device, in addition to a dialyzer.

[0204] Several embodiments of the invention have been described. However, it will be understood that various modifications can be made without departing from the spirit and scope of the invention. Therefore, other embodiments are also within the scope of the appended claims.

Claims

1. A blood therapy machine, comprising: A treatment module including a structure for releasable coupling with a dialyzer, the treatment module comprising: (i) a first pressure transducer positioned against a first membrane of a first pressure sensing chamber of the dialyzer when the dialyzer is coupled to the treatment module; and (ii) a second pressure transducer positioned against a second membrane of a second pressure sensing chamber of the dialyzer when the dialyzer is coupled to the treatment module. The first pressure transducer and the second pressure transducer are reconfigurable between: (i) a first position in which the first pressure transducer and the second pressure transducer are retracted; and (ii) a second position in which the first pressure transducer and the second pressure transducer are extended to abut against the first and second membranes, respectively.

2. The blood therapy machine according to claim 1, wherein, The first and second pressure transducers are positioned adjacent to opposite ends of the dialyzer when the dialyzer is coupled to the treatment module.

3. The blood therapy machine according to claim 1 or 2, wherein, The treatment module also includes: The first door is configured to open and close the first opening; and The second door is configured to open and close the second opening. The first pressure transducer is located near the first gate, and the second pressure transducer is located near the second gate.

4. The blood therapy machine according to claim 3, wherein, The treatment module can be reconfigured between: (i) a first configuration in which the first and second pressure transducers are retracted behind the first and second doors, respectively; and (ii) a second configuration in which the first and second doors are opened and the first and second pressure transducers extend through the first and second openings, respectively.

5. The blood therapy machine according to claim 4, wherein, The treatment module also includes: A first pair of tubing is configured to connect, when the dialyzer is coupled to the treatment module, to a first replacement fluid port and a first dialysate port defined by the dialyzer; and The second pair of tubing is configured to connect to the second replacement fluid port and the second dialysate port defined by the dialyzer when the dialyzer is coupled to the treatment module.

6. The blood therapy machine according to claim 5, wherein, In the first configuration, the first pair and the second pair of pipes are retracted behind the first and second doors, respectively, and in the second configuration, the first pair and the second pair of pipes extend through the first and second openings, respectively.

7. The blood therapy machine according to any one of claims 1, 2, 4-6, wherein, The treatment module includes a drive unit configured to generate a dynamic magnetic field when the dialyzer is coupled to the treatment module, causing the magnetic pump rotor within the dialyzer to levitate and rotate.

8. The blood therapy machine according to any one of claims 1, 2, 4-6, wherein the blood therapy machine further includes a blood therapy machine control console for controlling the treatment module, wherein, The treatment module is mounted on an arm that extends from the control console of the blood therapy machine.

9. The blood therapy machine according to any one of claims 1, 2, 4-6, wherein, Structures for releasably coupling with a dialyzer include a groove shaped to slidably receive a portion of the dialyzer.

10. A blood therapy system, comprising: Treatment module; and A dialyzer capable of being releasably coupled to a treatment module, the dialyzer comprising: case; Bundles of hollow fibers inside the shell; A first pressure detection chamber having a first outer wall including a first membrane; and A second pressure detection chamber having a second outer wall including a second membrane, The treatment module includes (i) a first pressure transducer positioned to abut a first membrane of a first pressure detection chamber when the dialyzer is coupled to the treatment module; and (ii) a second pressure transducer positioned to abut a second membrane of a second pressure detection chamber when the dialyzer is coupled to the treatment module; and The first pressure transducer and the second pressure transducer are reconfigurable between: (i) a first position in which the first pressure transducer and the second pressure transducer are retracted; and (ii) a second position in which the first pressure transducer and the second pressure transducer are extended to abut against the first and second membranes, respectively.

11. The blood therapy system according to claim 10, wherein, The dialyzer also includes a pump rotor located within the housing, the pump rotor being magnetically driven to force fluid through the inner cavity of the hollow fiber, and the treatment module including a pump drive unit that generates a dynamic magnetic field to suspend and rotate the pump rotor when the dialyzer is coupled to the treatment module.

12. The blood therapy system according to claim 10 or 11, wherein, The dialyzer includes a first end cap defining a first pressure detection chamber and a second end cap defining a second pressure detection chamber.

13. The blood therapy system according to claim 10 or 11, further comprising a blood therapy machine control console for controlling the treatment module, wherein, The treatment module is mounted on an arm that extends from the control console of the blood therapy machine.

14. The blood therapy system according to claim 13, wherein, The treatment module installed on the arm allows the treatment module and dialyzer to be positioned close to the patient during treatment, and venous and arterial patient tubing less than one meter in length is connected to the dialyzer.

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