Blood treatment system

Abstract

Dialyzer systems can integrate the technology and functionality of multiple blood treatment systems in a significantly integrated manner. For example, the present disclosure describes dialyzer systems that include magnetically driven and magnetically levitated pump rotors integrated into the dialyzer. Such dialyzers can be used with treatment modules that include pump drive units that generate magnetic fields. In some embodiments, the dialyzer includes a pressure transducer chamber having a flexible membrane that a corresponding pressure transducer of the treatment module can engage to detect arterial and / or venous pressure.

Description

TECHNICAL FIELD

[0001] The present invention relates to a blood treatment system and a method for extracorporeal blood treatment procedures. BACKGROUND

[0002] Renal dysfunction or failure, in particular end-stage renal disease, results in the body losing the ability to remove water and minerals, maintain acid-base balance, and control electrolyte and mineral concentrations within physiological ranges. Toxic uremic waste metabolites such as urea, creatinine, and uric acid accumulate in human tissues and can lead to death if the filtering function of the kidneys is not replaced.

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

[0004] During HD, blood is passed from a patient through a dialyzer that includes a semipermeable membrane that separates the blood from a large volume of externally provided dialysis solution (also called dialysate). Waste and toxins, including excess fluid, are dialyzed from the blood through the semipermeable membrane into the dialysate, which is then typically discarded. The transport of small molecular substances through the semipermeable membrane is primarily determined by the concentration difference between the dialysate and the blood. This dialysate is referred to as “fresh dialysate” before it receives the dialyzed components of the blood, and it is referred to as “spent dialysate” after it has received the dialyzed components.

[0005] During HDF, part of the serum that is drawn through the semipermeable membrane is replaced by sterile substitution fluid that is delivered to the extracorporeal blood flow upstream of the dialyzer or downstream of the dialyzer. The supply of substitution fluid upstream of the dialyzer is also referred to as predilution, while the supply downstream of the dialyzer is also referred to as postdilution. SUMMARY

[0006] The dialyzer systems described herein can include a magnetic drive and a magnetic levitation pump rotor integrated into a dialyzer. Such dialyzers are configured for use with the treatment modules described herein that include a pump drive unit that generates a magnetic field. In some embodiments, the dialyzers include a pressure sensor chamber having a flexible membrane-like wall against which a corresponding pressure transducer of the treatment module can be engaged to detect arterial and / or venous pressure. Additional features can be incorporated into the dialyzers and treatment modules as described herein to consolidate components, simplify setup, and enhance blood treatment performance.

[0007] In one aspect, the present disclosure relates to a dialysis treatment device. The dialysis treatment device includes a bar-shaped housing defining a longitudinal axis, and first and second end caps at opposite ends of the housing. A plurality of hollow membrane fibers are located within an interior of the housing between the first and second end caps. Each hollow membrane fiber defines an internal lumen. The dialysis treatment device further includes a pump rotor in the first end cap. The dialysis treatment device defines a blood flow path that extends through the first end cap, then through the internal lumens of the hollow membrane fibers, and then through the second end cap. The blood flow path: (i) enters the first end cap transverse to the longitudinal axis, (ii) then transitions to parallel to the longitudinal axis, (iii) then enters the pump rotor, (iv) then extends to the hollow membrane fibers after exiting the pump rotor.

[0008] Such a dialysis treatment device can optionally include one or more of the following features in any combination. In some embodiments, the dialysis treatment device is a dialyzer. The blood flow path can enter the pump rotor along a center of the pump rotor. The center of the pump rotor can be on the longitudinal axis of the housing. The blood flow path can enter the first end cap between the pump rotor and the plurality of hollow membrane fibers. In some embodiments, the pump rotor is a centrifugal impeller such that the blood flow path exits the centrifugal impeller transverse to the longitudinal axis. The first end cap can redirect the blood exiting the centrifugal impeller transverse to the longitudinal axis to flow to the hollow membrane fibers parallel to the longitudinal axis. The first end cap can define an annular space around the pump rotor. The dialysis treatment device can further include a check valve on the blood flow path. In some embodiments, the second end cap includes a port on the blood flow path for administering a medication or extracting a fluid sample. The housing can further include a deaeration chamber on the blood flow path. The deaeration chamber can be defined in the second end cap. The first end cap can include an internal support plate defining one or more openings through which the blood flow path passes after the pump rotor and before the hollow membrane fibers. In some embodiments, the one or more openings are at least two openings arranged symmetrically around the longitudinal axis. The second end cap can define a blood outlet from the dialysis treatment device. The dialysis treatment device can further include an arterial pressure detection chamber arranged between a blood inlet and the hollow fibers and having a first flexible surface. The first flexible surface can be attached to the first end cap. The first end cap can define a first dialysate port. The dialysis treatment device can further include a venous pressure detection chamber arranged in the second end cap between the hollow fibers and a blood outlet. The venous pressure detection chamber can have a second flexible surface.

[0009] In another aspect, the present disclosure relates to a blood treatment machine. The blood treatment machine includes a treatment module including structure for releasable coupling with a dialysis treatment apparatus or dialyzer having any of the configurations described above. The treatment module includes a drive unit configured to generate a dynamic magnetic field to levitate and rotate the pump rotor when the dialysis treatment apparatus or dialyzer is coupled with the treatment module.

[0010] Such a blood treatment machine can optionally include one or more of the following features in any combination. The blood treatment machine can further include a blood treatment machine console that controls the treatment module. The treatment module can be mounted to an arm that extends from the blood treatment machine console. In some embodiments, the treatment module or the arm to which it is mounted can include one or more sensors operable to determine an orientation or motion of the blood treatment module relative to the blood treatment machine console. In some embodiments, the treatment module further includes a first pair of conduits configured to connect with a first substitution fluid port and a first dialysate port defined by the dialyzer when the dialyzer is coupled with the treatment module. The treatment module can further include a second pair of conduits configured to connect with a second substitution fluid port and a second dialysate port defined by the dialyzer when the dialyzer is coupled with the treatment module.

[0011] In another aspect, the present disclosure relates to a system including a dialysis treatment apparatus or dialyzer having any of the configurations described above and a blood treatment machine having any of the configurations described above.

[0012] Embodiments can include one or more of the following advantages.

[0013] In certain embodiments, the various technologies and functions of blood treatment systems are integrated into dialyzer and treatment module systems as described herein in a significantly improved and integrated manner. For example, in certain embodiments, a single dialyzer unit as further described below can replace the important parts, tube group, air removal system, sample port and pump of traditional hollow fiber dialyzer. In addition, the end caps of some dialyzers as described herein may include an accessible pressure chamber with a flexible, membranous wall so as to conveniently measure arterial and venous pressures in a non-invasive manner. In certain embodiments, the end cap of dialyzer may include a port for (a) receiving fresh dialysate from treatment module, and (b) returning waste dialysate to the port of treatment module after passing through dialysis membrane. In certain embodiments, the end cap of dialyzer may also include a port, by which replacement fluid can be directly added to blood before and / or after blood passes through the hollow fiber blood treatment section of dialyzer. In addition, in certain embodiments, identical dialyzer and treatment module systems are configured to perform any of a variety of different types of blood treatments, including, for example, HD and HDF.

[0014] Compared to typical HD and HDF machines, some example embodiments reduce the number of required setup steps, which can reduce setup time and reduce the chance of human error. In a clinic, this can free up valuable nursing resources and simplify patient care. This simplification can free up nursing staff or other personnel resources in a clinic or home setting and make the process of self-configuring a dialysis machine easier and more feasible for patients.

[0015] In some embodiments, the integrated dialyzer and treatment module system described herein provides important functional advantages. For example, integration can reduce the amount of tubing required for the extracorporeal circuit used in the blood treatment phase. In addition, the treatment module can be mounted on an arm extending from the blood treatment machine console so that the treatment module and dialyzer can be placed very close to the patient. These features significantly reduce the length of the extracorporeal tubing required for the blood treatment phase. Therefore, the volume required for the perfusion solution is advantageously reduced. In addition, the exposure of the patient's blood to contact with foreign surfaces is also advantageously reduced. The integrated form factor also brings other advantages, such as less likelihood of leakage, less hemolysis, less biohazard waste, less packaging waste, and reduced transportation costs.

[0016] In some embodiments, the magnetic pump rotor is integrated into the dialyzer in a fluid-tight manner. This integrated pump rotor can be bearingless, magnetically suspended, and rotationally driven by an external pump drive unit that generates a dynamic magnetic field. Compared to conventional pumping systems for extracorporeal blood treatment, this arrangement offers the following advantages: hemolysis is reduced, and the bearingless design reduces system maintenance requirements and the potential for contamination. Furthermore, since the pump drive unit and pump rotor are separate, this advantageously facilitates easier cleaning of the machine interface.

[0017] In some embodiments, the integrated dialyzer and treatment module system described herein is also easier to set up and use compared to conventional systems. As a result, set up time can be reduced and the likelihood of errors can be reduced. As a result, in some embodiments, the cost of treatment per patient can be reduced.

[0018] The details of one or more embodiments are set forth in the accompanying drawings and the description below. Other aspects, features, and advantages will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 A patient receiving extracorporeal blood treatment using a blood treatment system is shown.

[0020] Figure 2 is an exploded perspective view of a dialyzer and treatment module system of the blood treatment system of Figure 1

[0021] Figure 3 is a perspective view of the dialyzer and treatment module system of Figure 2

[0022] Figure 4 is a schematic view of a dialyzer of the blood treatment system of Figure 1

[0023] Figure 5 is another schematic view of a dialyzer of the blood treatment system of Figure 1

[0024] Figure 6 is another schematic view of a dialyzer of the blood treatment system of Figure 1

[0025] Figure 7 is another schematic view of a dialyzer of the blood treatment system of Figure 1

[0026] Figure 8 is a rear view of the dialyzer of the blood treatment system of Figure 1

[0027] Figure 9 is a front view of the dialyzer of the blood treatment system of Figure 1

[0028] Figure 10 is a front view of the dialyzer of the blood treatment system of Figure 1 ​​​​​​​​Side view of a dialyzer of a blood treatment system of the

[0029] Figure 11 is Figure 1 Top view of a dialyzer of a blood treatment system of the

[0030] Figure 12 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 10 along section line A-A of

[0031] Figure 13 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 11 along section line B-B of

[0032] Figure 14 is Figure 1 Cross-sectional view of a second end cap of a dialyzer of a blood treatment system of the Figure 11 along section line C-C of

[0033] Figure 15 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 10 along section line D-D of

[0034] Figure 16 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 10 along section line E-E of

[0035] Figure 17 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 11 along section line B-B of

[0036] Figure 18 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 10 along section line F-F of

[0037] Figure 19 is Figure 1 Cross-sectional view of a dialyzer of a blood treatment system of the Figure 10 along section line G-G of

[0038] Figure 20 is Figure 1 Perspective view of a first end cap of a dialyzer of a blood treatment system of the along section line G-G of

[0039] Figure 21 is Figure 20 a rear view of the first end cap.

[0040] Figure 22 is Figure 20 another perspective view of the first end cap.

[0041] Figure 23 is Figure 20 a perspective view of the first end cap shown in partial longitudinal section and illustrating blood flow therethrough.

[0042] Figure 24 is a perspective view of a pump rotor configured to be located in the first end cap of Figure 20

[0043] Figure 25 is a perspective view of an alternative pump rotor that can be used in the first end cap of Figure 20

[0044] Figure 26 is Figure 1 a perspective view of a second end cap of a dialyzer of the blood treatment system of

[0045] Figure 27 is Figure 26 a rear view of the second end cap.

[0046] Figure 28 is Figure 26 another perspective view of the second end cap.

[0047] Figure 29 is a sectional view of an alternative second end cap.

[0048] Figure 30 is a perspective view of a treatment module of the blood treatment system of Figure 1 in a first configuration.

[0049] Figure 31 is a perspective view of the treatment module of Figure 30 in a second configuration.

[0050] Figure 32 is an exploded perspective view showing the first end cap of Figure 20 and a first pressure sensor and a first pair of conduits of the treatment module. Figure 30

[0051] Figure 33 is a top perspective view of the first end cap, the first pressure sensor and the first pair of conduits of Figure 32 shown in a detached configuration.

[0052] Figure 34 is shown in an operable coupled configuration.​​​Figure 32 Top perspective view of a first end cap, a first pressure sensor, and a top of a first pair of conduits of the blood treatment system of FIG. 1.

[0053] Figure 35 Perspective view of an alternative treatment module.

[0054] Figure 36 Perspective view of an alternative first (arterial) end cap shown in partial longitudinal section.

[0055] Figure 37 Perspective view of an alternative second (venous) end cap. Figure 1 Rear view of an exemplary dialyzer of the blood treatment system of FIG. 1 (except without HDF functionality).

[0056] Figure 38 Front view of the dialyzer of FIG. 1. Figure 37

[0057] Side view of the dialyzer of FIG. 1. Figure 39 Figure 37 Longitudinal section view of an alternative second (venous) end cap. The venous end cap is shown in a first configuration.

[0058] Figure 40 Perspective view showing a portion of the venous end cap of FIG. 1.

[0059] Figure 41 Figure 40 Perspective view of another portion of the venous end cap of FIG. 1.

[0060] Figure 42 Perspective view of another alternative second (venous) end cap.

[0061] Figure 43 Longitudinal section view of the venous end cap of FIG. 1. Figure 42

[0062] Another perspective view of the venous end cap of FIG. 1. Figure 44 Figure 42 Longitudinal section view of another alternative second (venous) end cap. The venous end cap is shown in a first configuration.

[0063] Figure 45 Longitudinal section view of the venous end cap of FIG. 1 in a second configuration.

[0064] Figure 46 Figure 45 Perspective view showing a portion of the venous end cap of FIG. 1.

[0065] Figure 47 Perspective view of another portion of the venous end cap of FIG. 1. Figure 45

[0066] Like reference numbers in the various figures indicate like elements. DETAILED DESCRIPTION

[0067] ​​​​​The present disclosure describes dialyzer systems that can include a magnetically driven, magnetically levitated pump rotor integrated into a dialyzer. Such dialyzers can be used with treatment modules described herein that include a pump drive unit that generates a dynamic magnetic field. In some embodiments, the dialyzer includes one or more pressure sensor chambers with flexible outer membrane walls that are engaged by corresponding pressure transducers of the treatment module to detect arterial and / or venous pressure. The dialyzer systems described herein integrate a variety of technologies and functions of a blood treatment system in a significantly integrated manner to consolidate components, reduce cost, simplify setup, and enhance performance.

[0068] Reference is made to Figure 1 Patient 10 is shown as receiving extracorporeal blood treatment using a blood treatment system 1 that includes a disposable set connected to a blood treatment machine 200. The disposable set includes a dialyzer 100 coupled to a treatment module 220 of the blood treatment machine 200. In some cases, patient 10 can be receiving treatment for a health condition such as kidney failure. Accordingly, system 1 can be used to provide one or more types of treatment to patient 10, including hemodialysis (HD), hemodiafiltration (HDF), or some other type of blood treatment. For such treatments, blood is drawn from patient 10 via an arterial line 102, and after passing through dialyzer 100, treated blood is returned to patient 10 via a venous line 104. Dialyzer 100 is a single-use disposable, while blood treatment machine 200 is a durable, reusable system. In some cases, a single dialyzer 100 can be reused two or more times for a particular individual patient.

[0069] Blood treatment machine 200 includes a blood treatment machine console 210, a treatment module 220, and an arm 280 connecting treatment module 220 to blood treatment machine console 210. Arm 280 extends from blood treatment machine console 210, and treatment module 220 is mounted to the other end of arm 280. In other words, treatment module 220 is cantilevered from blood treatment machine console 210 by arm 280.

[0070] Arm 280 includes one or more adjustable joints so that arm 280 can be manually articulated to position treatment module 220 in various positions / orientations relative to blood treatment machine console 210 and / or relative to patient 10. For example (as shown in FIG. 1), arm 280 can be manually articulated to position treatment module 220 in a first position / orientation (as shown in FIG. 1) and a second position / orientation (as shown in FIG. 2). Figure 1As shown in FIG. 2, in some cases, the arm 280 can be extended such that the treatment module 220 is positioned proximate to the patient 10. As a result, the arterial line 102 and the venous line 104 can be short in comparison to conventional blood treatment systems. For example, in some embodiments, the arterial line 102 and the venous line 104 are less than one meter in length (e.g., less than 90 cm, less than 80 cm, less than 70 cm, less than 60 cm, less than 50 cm, less than 40 cm, less than 30 cm, or less than 20 cm).

[0071] In some embodiments, the treatment module 220 and / or the arm 280 can include one or more sensors 226 that output signals indicative of the position, orientation, and / or motion of the treatment module 220 relative to the blood treatment machine console 210. For example, in some cases, such as an accelerometer (e.g., a 3D accelerometer), a gyroscope sensor, an ultrasonic sensor, a proximity sensor, an optical sensor, a magnetometer, a global positioning sensor, a radio triangulation sensor (e.g., like in keyless entry systems for cars or based on WiFi, Bluetooth, or similar technologies), an electronic level, an electrical level, and / or similar sensors within the treatment module 220 and / or the arm 280 can be used to indicate the position, orientation, and / or motion of the treatment module 220 relative to the blood treatment machine console 210.

[0072] In some embodiments, the signal output from such sensors 226 can be used by the control system of the blood treatment system 1 as an input, for example for activating or deactivating certain operating modes of the blood treatment system 1, or, alternatively, for determining the current status of the treatment module 220. For example, a certain orientation of the treatment module 220 can be used to indicate that a maintenance mode should be activated. Pulling the treatment module 220 forward towards the patient can initiate the preparation of a treatment mode. Another certain orientation of the treatment module 220 can be defined to indicate that a deaeration mode is activated. Pushing the treatment module 220 back towards the blood treatment machine console 210 can act as an input for pausing the operation of the blood treatment system 1, etc. Other operating modes of the blood treatment system 1 that can be activated in response to a certain position, orientation or movement of the treatment module can include, but are not limited to, a "nurse mode", a commissioning mode and a priming or filling mode, to provide some examples. The sensors 226 including one or more outputs that can indicate the position, orientation and / or movement of the treatment module 220 relative to the blood treatment machine console 210 allow the user to control the interaction with the blood treatment system 1 conveniently and intuitively by manually handling the arm-mounted treatment module 220. The electronics and / or control means that receive and interpret the output signals from the sensors 226 can be located in the blood treatment machine console 210, the treatment module 220, the arm 280 and / or elsewhere. In some embodiments, the raw data from one or more sensors 226 is processed in a separate step to generate a sensor output that is used in a further step. In some embodiments, the processor that performs this processing step is located in the treatment module 220. In some embodiments, the processor that performs this processing step is located in the arm 280. In some embodiments, the processor that performs this processing step is located in the blood treatment machine console 210.

[0073] In some embodiments, there are additionally or alternatively sensors in the arm 280 to determine the position and / or orientation of the treatment module 220. Such sensors can be angle sensors, path sensors, range sensors and / or other types of sensors. In some embodiments, such sensors can be used to identify whether a case of mechanical impact has occurred, for example in the case of a mechanical impact of a person or object coming into contact with the treatment module 220. The detection of an impact event can be used to identify an alarm as a false alarm when the alarm occurs simultaneously in other sensors that are triggered by an impact event. For example, an ultrasonic air bubble detector can produce a sensor reading when an impact event occurs, causing an alarm. An accelerometer or position sensor in the treatment module 220 and / or the arm 280 is able to detect an impact event that occurs at the time of the alarm. In this case, the treatment module control considers that the bubble detector reading can have been falsified by the detected impact event and can downgrade the alarm stepwise.

[0074] Other advantages of using such a sensor as described above include, in combination with a deaeration mode or a priming mode, using the sensor reading to initiate a certain operational state to reduce the workload of the personnel operating the treatment module 220. In addition, the tactile input channel will allow for a more intuitive way of operating the treatment module 220. Furthermore, these concepts can help to avoid errors and mistakes in the operation and treatment and error alarms can be identified.

[0075] In some embodiments, the output signal from the sensor 226 can be directed to a control unit in the treatment module 220 and / or the control console 210, and the control unit can be configured or programmed to disable or enable predefined processes of the blood treatment system 1 depending on the signal. In some embodiments, a priming phase of the dialyzer 100, which means filling the dialyzer 100 with liquid and deaerating the dialyzer 100, and / or a treatment phase of the blood treatment system 1 is only enabled when the signal indicates that the dialyzer 100 is in an upright position. In some embodiments, the signal from the sensor 226 has to indicate the angular position of the treatment module 220 relative to the ground (relative to the earth's horizon) so that any liquid that can flow out of the liquid circuit does not drip to the ground but is conducted along the surface of the treatment module 220 and directed to a liquid collection port of the treatment module 220. The liquid collection port can be guided along the lower end of the treatment module 220 and connected to a container to collect the leaked liquid by a rail.

[0076] The control unit can further be connected to a user interface, e.g. the user interface 212. The 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 as provided by the signal from the sensor 226 and the display can change the visible appearance depending on the enabled process.

[0077] In one example embodiment, when the next process step is a priming phase for example, the graphical user interface will display the orientation of the treatment module 220. The orientation can only be displayed in green color when the treatment module 220 is in an upright position as detected by the signal from the sensor 226 and the operator will be able to manually initiate the priming phase via a user interface action (e.g. voice, button, gesture, etc.) or the system will automatically initiate the next process step.

[0078] While the illustrated example includes a treatment module 220 that is movable relative to the base console 210, it is understood that some other examples do not include a treatment module 220 that is individually positionable. In such examples, the base console 210 can incorporate the other described features described for the illustrated treatment module 220, except for those particular features directed to positionability.

[0079] The blood treatment machine console 210 includes a user interface 212, a control system, a facility for making dialysate, etc.

[0080] In the blood treatment system 1, much of the structure associated with conventional systems is incorporated into the dialyzer 100 and the portion of the blood treatment module 220 that interfaces with the dialyzer 100. Conventional blood treatment systems typically include disposable tubing sets and / or cartridges (in addition to the dialyzer). Such tubing sets and / or cartridges are used to interface with one or more pieces of hardware such as pumps, sensors, valve actuators, etc. However, the dialyzer 100 and the blood treatment machine 200 integrate a variety of functionality in a highly integrated manner (as described further below).

[0081] Referring also to Figure 2 and Figure 3 , the dialyzer 100 is releasably coupled to the treatment module 220 in a convenient manner. For example, in the illustrated embodiment, the dialyzer 100 is slidably coupled with the treatment module 220. Accordingly, the dialyzer 100 and the treatment module 220 include complementary structural features to facilitate the slidable coupling. In other words, the dialyzer 100 includes a first protrusion 106 that is slidably couplable with a first complementarily shaped slot 222 of the treatment module 220, and the dialyzer 100 includes a second protrusion 108 that is slidably couplable with a second complementarily shaped slot 224 of the treatment module 220. In some embodiments, other manners of releasably connecting the dialyzer 100 to the treatment module 220 can be used. For example, in some embodiments, connection manners such as snap connections, thumbscrew connections, clamping connections, suction connections, etc. can be used.

[0082] The dialyzer 100 includes a housing 110 that defines an interior space. A bundle of hollow fiber semi-permeable membranes (or simply "hollow fibers") is disposed in the interior of the housing 110. The arterial line 102 and the venous line 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 lumens of the hollow fibers.

[0083] The housing 110 includes a first end cap 120 and a second end cap 140. The first end cap 120 includes the first protrusion 106, and the second end cap 140 includes the second protrusion 108. Further, the arterial line 102 is coupled to the first end cap 120, and the venous line 104 is coupled to the second end cap 140.

[0084] The treatment module 220 includes a pump drive unit 230 that is configured to releasably receive a portion of the first end cap 120. As described further below, the pump drive unit 230 generates a dynamic magnetic field to levitate and rotate a pump rotor housed within the portion of the first end cap 120. In some embodiments, the pump drive unit 230 does not include moving parts.

[0085] The pump rotor is configured such that rotation of the pump rotor forces blood of the patient 10 through the lumens of the hollow fibers 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 lumens of the hollow fibers, and out of the dialyzer 100 via the venous line 104.

[0086] The treatment module 220 also includes other devices that interface with the arterial line 102 and / or the venous line 104. For example, the illustrated treatment module 220 includes a tube interface module 240 that is configured to releasably receive a portion of the arterial line 102 and / or a portion of the venous line 104. The tube interface module 240 can include devices that can perform functions such as flow rate detection, bubble detection, and the like. In other words, the tube interface module 240 can include sensors for detecting one or more parameters (e.g., flow rate, hematocrit (Hct), and other blood properties of blood within the arterial line 102 and / or the venous line 104) and / or for detecting bubbles (e.g., air bubbles) in the blood within the arterial line 102 and / or the venous line 104. In some embodiments, flow rate detection and / or bubble detection are performed using sensors such as ultrasonic sensors, optical sensors, or other suitable types of sensors. In other embodiments, sensors for detecting bubbles can be located at or in the end caps of the disposable of the dialyzer 100.

[0087] The treatment module 220 also includes an arterial line clamp 242 and a venous line clamp 244. The clamps 242 and 244 are used to completely restrict or completely non-restrict (e.g., in an on / off valve manner) the flow of blood within the arterial line 102 and / or the venous line 104, respectively.

[0088] As described further below, the treatment module 220 also includes devices for interfacing with the dialyzer 100 to measure pressure at certain locations within the dialyzer 100. Additionally, as described further below, the treatment module 220 includes conduits that are selectively interfaceable with the dialyzer 100 to facilitate the flow of liquids such as replacement fluid and / or dialysate between the dialyzer 100 and the treatment module 220.

[0089] Figures 4 to 7 is a schematic view of the dialyzer 100. For ease of understanding, Figure 4 only blood flow through the dialyzer 100 is shown. Figure 5 blood and replacement fluid flow is shown. Figure 6 only dialysate flow is shown, Figure 7 blood, replacement fluid, and dialysate flow is shown.

[0090] Figures 4 to 7simplified to show the overall flow relationships in dialyzer 100. For example, first potting 115 and second potting 116 of the two respective ends of each fiber in the bundle of stationary hollow fibers 114 are omitted to simplify the illustration. In addition to the bundle of stationary hollow fibers, these potting 115 and 116 also maintain a barrier between the blood and the dialysate. The potting 115 and 116 and the associated flow paths are described in more detail below in connection with Figures 8 to 29 Further details are described in further detail.

[0091] Reference is made to Figure 4 The housing 110 of dialyzer 100 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 the bundle of hollow fibers 114. As noted above, a more detailed description of the structure of dialyzer 100, including the bundle of hollow fibers 114, is provided below in connection with Figures 8 to 29 Further details are described in further detail.

[0092] 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 shrouded within the pump housing 130. Thus, the pump rotor 132 is contained in a fixed position relative to the bundle of hollow fibers 114.

[0093] According to some embodiments, the pump rotor 132 is a radial pumping impeller having a hollow central volume region. The blades (or leaves) of the impeller of the pump rotor 132 are arranged so that they at least partially project or extend radially. 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.

[0094] The pump rotor 132 is operated and controlled by engagement with a pump drive unit 230 (shown in Figure 2 and Figure 3 of therapy module 220, as described further herein. That is, the pump rotor 132 can be levitated and rotated by a magnetic field emitted from the pump drive unit 230 during use.

[0095] The 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 before the pump rotor 132. That is, the arterial pressure sensing chamber 122 is arranged to facilitate measurement of pre-pump arterial pressure. Additionally or alternatively, in some embodiments, pressure can also be measured post-pump (but before the hollow fibers 114). As described further below, both pressure sensing chambers 122 and 142 are configured to engage with respective pressure transducers of therapy module 220.

[0096] Reference will now be made toFigure 4 The dashed line in FIG. 1 illustrates the flow path of blood through the dialyzer 100. Blood flows into the first end cap 120 via the arterial line 102 (shown in FIG. 2) and into the arterial pressure detection chamber 122. The arterial pressure detection chamber 122 is positioned along the flow path of blood into the first end cap 120. The blood flow path transitions to be parallel to the longitudinal axis of the dialyzer 100 to deliver blood to the pump rotor 132. Blood is directed to the center of the pump rotor 132. Rotation of the centrifugal pump rotor 132 forces 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 toward the middle housing portion 112. The blood enters the lumens of the bundle of hollow fibers 114 and continues to flow longitudinally toward the second end cap 140. After passing through the middle housing portion 112, the blood flows out of the bundle of hollow fibers 114, into the second end cap 140, and out of the second end cap 140 via the venous line 104. The venous pressure detection chamber 142 is positioned along the blood flow path in the second end cap 140. In some embodiments, a one-way check valve is positioned along the blood flow path as the blood flows out of the second end cap 140 into the venous line 104. In some embodiments, the one-way check valve is included on a side arm connection to the blood flow path to prevent backflow fluid flow or blood into the side arm connection. Figure 2 The dashed line in FIG. 1 illustrates the flow path of blood through the dialyzer 100. Blood flows into the first end cap 120 via the arterial line 102 (shown in FIG. 2) and into the arterial pressure detection chamber 122. The arterial pressure detection chamber 122 is positioned along the flow path of blood into the first end cap 120. The blood flow path transitions to be parallel to the longitudinal axis of the dialyzer 100 to deliver blood to the pump rotor 132. Blood is directed to the center of the pump rotor 132. Rotation of the centrifugal pump rotor 132 forces 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 toward the middle housing portion 112. The blood enters the lumens of the bundle of hollow fibers 114 and continues to flow longitudinally toward the second end cap 140. After passing through the middle housing portion 112, the blood flows out of the bundle of hollow fibers 114, into the second end cap 140, and out of the second end cap 140 via the venous line 104. The venous pressure detection chamber 142 is positioned along the blood flow path in the second end cap 140. In some embodiments, a one-way check valve is positioned along the blood flow path as the blood flows out of the second end cap 140 into the venous line 104. In some embodiments, the one-way check valve is included on a side arm connection to the blood flow path to prevent backflow fluid flow or blood into the side arm connection. Figure 3 The dashed line in FIG. 1 illustrates the flow path of blood through the dialyzer 100. Blood flows into the first end cap 120 via the arterial line 102 (shown in FIG. 2) and into the arterial pressure detection chamber 122. The arterial pressure detection chamber 122 is positioned along the flow path of blood into the first end cap 120. The blood flow path transitions to be parallel to the longitudinal axis of the dialyzer 100 to deliver blood to the pump rotor 132. Blood is directed to the center of the pump rotor 132. Rotation of the centrifugal pump rotor 132 forces 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 toward the middle housing portion 112. The blood enters the lumens of the bundle of hollow fibers 114 and continues to flow longitudinally toward the second end cap 140. After passing through the middle housing portion 112, the blood flows out of the bundle of hollow fibers 114, into the second end cap 140, and out of the second end cap 140 via the venous line 104. The venous pressure detection chamber 142 is positioned along the blood flow path in the second end cap 140. In some embodiments, a one-way check valve is positioned along the blood flow path as the blood flows out of the second end cap 140 into the venous line 104. In some embodiments, the one-way check valve is included on a side arm connection to the blood flow path to prevent backflow fluid flow or blood into the side arm connection.

[0097] The second end cap 140 can also be configured to de-aerate blood as it enters and flows through the second end cap 140. Accordingly, the second end cap 140 includes an air purge 144 that allows air and other gases to exit the second end cap 140 while preventing fluid, such as blood, from flowing therethrough. The air purge 144 can also serve as an access port. That is, the air purge 144 can be configured for use in purposes such as sample extraction and administration of medication (e.g., heparin). The air purge 144 can include a plastic tube that extends from the second end cap 140. An elastomeric seal located within the plastic tube is configured to open when a syringe without a needle is coupled to the air purge 144.

[0098] Again, blood purified and treated by the dialyzer 100 flows through the interior lumens of the hollow fibers 114 (while dialysate flows between the exterior of the hollow fibers 114 in the space between the exterior of the hollow fibers 114 over / along the exterior of the hollow fibers 114 through the dialyzer 100, as further described herein). This is exactly opposite to how blood flows through an extracorporeal blood oxygenator device, which also uses hollow fibers made of permeable material. Extracorporeal blood oxygenators are used to perform treatments such as extracorporeal membrane oxygenation (“ECMO”), and in cooperation with heart-lung machines for surgical procedures such as coronary artery bypass grafting (“CABG”), heart valve replacement / repair, heart transplants, and so on. While an extracorporeal blood oxygenator can include a bundle of hollow fibers made of permeable material similar to the dialyzer 100, blood passing through the extracorporeal blood oxygenator flows over / along the exterior of the hollow fibers (as opposed to through the interior lumens of the hollow fibers as with the dialyzer 100), and gas flows through the interior lumens of the hollow fibers.

[0099] Thus, because the type of blood flow path for the dialyzer 100 is fundamentally different compared to an extracorporeal blood oxygenator, there are significant differences in the pressure and flow parameters of blood passing through the dialyzer 100 compared to 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).

[0100]

[0101] Table 1

[0102] The ratio of pressure to flow rate associated with blood flowing through a dialyzer or extracorporeal oxygenator can also be referred to as a “hemolysis risk factor.” The risk of hemolysis (damage to red blood cells) increases as the ratio of pressure to flow rate increases. Thus, the term “hemolysis risk factor” quantifies a useful parameter associated with the physical construction and use of dialyzers and extracorporeal oxygenator devices.

[0103] As can be seen from Table 1, for example, the hemolysis risk factor (ratio of pressure to flow rate during use) experienced by blood using a dialyzer 100 is much higher compared to during extracorporeal oxygenation. For example, in the example of Table 1, the hemolysis risk factor for dialysis is 3.11, while the hemolysis risk factor for extracorporeal oxygenation is 0.33. This is a difference of about 10: 1. In other words, the ratio of pressure to flow rate or hemolysis risk factor during dialysis is about 10 times greater than during extracorporeal oxygenation. This comparison is one way of illustrating and understanding the substantial physical differences between dialyzers (e.g., the dialyzer 100) and extracorporeal oxygenator devices.

[0104] Reference Figure 5dialyzer 100 is also configured to receive one or more additive replacement fluids in combination with the blood within the dialyzer 100. For example, in the illustrated embodiment, the first end cap 120 defines a first replacement fluid port 124 and the second end cap 140 defines a second replacement fluid port 148. The first replacement fluid port 124 is in direct fluid communication with the incoming blood flow path defined by the first end cap 120 and merges with it prior to the arterial pressure detection chamber 122. Alternatively, in some embodiments, the replacement fluid can be added to the blood after exiting the pump housing 130 (i.e., after being pressurized by the pump rotor 132) but prior to entering the lumens of the hollow fibers 114. The second replacement fluid port 148 is in direct fluid communication with the outgoing blood flow 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 can include a respective one-way check valve to prevent liquid from exiting the end caps 120 and 140 via the replacement fluid ports 124 and 148, respectively.

[0105] Referring to Figure 6 dialyzer 100 is also configured to receive dialysate and direct the dialysate to flow through the housing 110. For example, in the illustrated embodiment, the second end cap 140 defines a dialysate inlet 149 and the 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 the middle housing portion 112 containing the bundle of hollow fibers 114. The dialysate flows through the middle housing portion 112 via the spaces defined between the outer diameters of the fibers of the bundle of hollow fibers 114. In other words, as the blood flows within the lumens of the fibers of the bundle of hollow fibers 114, the dialysate flows along the outside 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 middle housing portion 112 and into the first end cap 120. The dialysate exits the first end cap 120 via the dialysate outlet 125.

[0106] Referring to Figure 7 The flow paths for the blood, replacement, and dialysate (as described above with respect to Figures 4 to 6 , respectively) are now shown in combination (e.g., what would occur during use of the dialyzer 100). When the replacement is added, it combines directly with the blood in the end cap 120 and / or 140. In contrast, the dialyzer 100 keeps the dialysate separate from the blood. However, waste from the blood (e.g., urea, creatinine, potassium, and additional fluid) is transferred from the blood to the dialysate via osmosis through the semi-permeable walls of the fibers of the bundle of hollow fibers 114 in the dialyzer 100.

[0107] Referring to Figures 8 to 10 the above description of the flow paths for the blood, replacement, and dialysate in Figures 4 to 7The description of the structure and function of dialyzer 100 provided in the context of the schematic view can be used to facilitate an understanding of the structure and function of actual embodiments of dialyzer 100 shown herein. Dialyzer 100 includes a housing 110 that includes a first end cap 120, a middle housing portion 112 containing a bundle of hollow fibers 114, and a second end cap 140. An arterial line 102 is connected to first end cap 120. A venous line 104 is connected to second end cap 140. In this example, arterial line 102 and venous line 104 are permanently bonded (e.g., solvent bonded, laser welded, etc.) to first end cap 120 and second end cap 140, respectively. However, it should be understood that in other examples, one or both of these connections can utilize any other suitable permanent or removable fluid-tight connection, including, for example, press fit and snap lock connectors.

[0108] First end cap 120 includes a pump housing 130, a first substitution fluid port 124, and a dialysate outlet 125. First end cap 120 also includes an arterial pressure sensing chamber 122. The outer wall of arterial pressure sensing chamber 122 (as can be seen in the rear view of Figure 8 includes a flexible membrane 160. As described further herein (e.g., with reference to Figures 31 to 33 ), when dialyzer 100 is operated with treatment module 220, a pressure transducer (e.g., 222 and 224) of treatment module 220 engages (e.g., abuts against) flexible membrane 160 of arterial pressure sensing chamber 122. Figures 1 to 3 and Figure 30 ) of treatment module 220 engages (e.g., abuts against) flexible membrane 162 of venous pressure sensing chamber 142.

[0109] Second end cap 140 includes a second substitution fluid port 148, a dialysate inlet 149, and a venous pressure sensing chamber 142. The outer wall of venous pressure sensing chamber 142 (as can be seen in the rear view of Figure 8 includes a flexible membrane 162. As described further herein (e.g., with reference to Figures 31 to 33 ), when dialyzer 100 is operated with treatment module 220, a pressure transducer (e.g., 222 and 224) of treatment module 220 engages (e.g., abuts against) flexible membrane 162 of venous pressure sensing chamber 142. Figures 1 to 3 and Figure 30 ) of treatment module 220 engages (e.g., abuts against) flexible membrane 162 of venous pressure sensing chamber 142. An air purge 144 is also attached to second end cap 140 and is in fluid communication with the interior of second end cap 140.

[0110] With reference to Figures 20 to 22 , first end cap 120 is shown separated from the other portions of dialyzer 100 to make the structural details of first end cap 120 more visible. In Figure 21 and 22 , arterial flexible membrane 160 is not shown to facilitate showing other features of arterial pressure sensing chamber 122. Reference is also made to Figure 16, blood to be treated in the dialyzer 100 flows into the first end cap 120 via the arterial line 102. The blood enters the arterial mixing chamber 163, and then flows from the arterial mixing chamber 163 into the arterial pressure detection chamber 122. For example, when the blood treatment system 1 is operated in the pre-dilution HDF mode, the blood can pass through the arterial mixing chamber 163 without being diluted or mixed with a replacement fluid.

[0111] In the case where a substitute is added to the arterial mixing chamber (e.g., pre-diluted HDF), the substitute flows from the first substitute supply conduit 254 into the first end cap 120 via the first substitute fluid port 124. The substitute then flows through the arterial substitute supply tube 165. The substitute then passes through the check valve 167 and enters the arterial mixing chamber 163. The flow of the substitute is via Figure 16 16. The arterial pressure sensing chamber 122i is shown as a series of arrows 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 is mixed with the incoming arterial blood flow (indicated by the upward-pointing arrows) before passing through the arterial pressure sensing chamber inlet 122i. The check valve 167 prevents blood from flowing into the arterial replacement fluid supply tube 165 and the first replacement fluid inlet 124. This prevents contamination of the first replacement fluid supply line 254 with blood.

[0112] Blood (undiluted or diluted with a substitute, depending on the operating mode of the treatment system 1) flows through the arterial pressure sensing chamber inlet 122i and enters the arterial pressure sensing chamber 122. The blood flow through the arterial pressure sensing chamber 122 allows the arterial pressure transducer 250 ( Figures 31 to 33 As shown) arterial blood pressure is measured via membrane 160. Figure 13 As shown by the arrow in , blood leaves the arterial pressure detection chamber 122 via the arterial pressure detection chamber outlet 122o. After leaving the arterial pressure detection chamber 122, the blood then flows to the pump housing 130 through the rotor supply tube 103. The rotor supply tube 103 defines a fluid flow path transverse to the longitudinal axis Z of the dialyzer 100.

[0113] The first end cap 120 further includes a dialysate outlet 125. The dialysate flows from the peripheral inner wall area of ​​the first end cap 120 to the dialysate outlet 125 through the dialysate outlet pipe 126. Figure 16 As shown, a one-way flow valve 167 (eg, a check valve) can be included in the first replacement fluid port 124 and the arterial line 102 .

[0114] refer to Figure 13 and Figure 23 ,pass Figure 13 A longitudinal cross-sectional view of the dialyzer 100 and Figure 23A partial longitudinal cross-sectional perspective view of the first end cap 120 in the dialyzer 100 can more clearly show the flow path of blood (which can be undiluted or diluted by a substitution fluid, as described above) through the first end cap 120. Blood flows from the rotor supply tube 103 toward the pump housing 130. A 90° bend at the end of the rotor supply tube 103 directs the blood to turn and flow parallel to the longitudinal center axis Z of the dialyzer 100 in 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.

[0115] Referring also to Figure 24 , the exemplary pump rotor 132 includes a first plate 133, a magnetic disk 136, and a plurality of vanes 135 (or leaves) extending between the first plate 133 and the magnetic disk 136. According to some embodiments, the pump rotor 132 is a pump impeller including a radial pumping impeller wheel having a hollow central volume region. Thus, the illustrated pump rotor 132 can also be referred to as a pump impeller. The leaves (or vanes) of the impeller wheel of the pump rotor 132 can be arranged such that they at least partially project or extend radially. 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.

[0116] The first plate 133 is an annular ring defining a central aperture 134. In some embodiments, the first plate 133 is omitted, and the vanes 135 extend from the magnetic disk 136 and terminate without the first plate 133. The magnetic disk 136 defines a central cavity 131 Figure 23 ) extending along the longitudinal center axis Z of the dialyzer 100. The magnetic disk 136 can include unencapsulated or encapsulated dipole magnets (such as rare earth magnets, ferrite ceramic magnets, and other suitable types of magnets). In the illustrated embodiment, the vanes 135 are arcuate members.

[0117] Rotation of the pump rotor 132 causes blood to flow as indicated by the large arrows in Figure 13 and Figure 23 . In some embodiments, the pump rotor 132 is driven to rotate at a speed (revolutions per minute) in a 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 during operation, but is not limited thereto.

[0118] In some embodiments, the height of the vane 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.

[0119] In some embodiments, the diameter of the outlet of the rotor supply tube 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 bore 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. Thus, in some embodiments, the diameter of the central bore 134 of the pump rotor 132 is greater than, equal to, or less than the diameter of the outlet of the rotor supply tube 103. Further, 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 tube 103. Further, in some embodiments, the diameter of the central bore 134 of the pump rotor 132 is greater than, equal to, or less than the diameter of the outlet of the rotor supply tube 103.

[0120] In some embodiments, the gap between the top surface of the first plate 133 and the opposing lower surface of the internal 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, during operation (e.g., when the pump rotor 132 is levitated). Similarly, in some embodiments, the gap between the bottom of the magnetic 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, during operation (e.g., when the pump rotor 132 is levitated). 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 internal support plate 121 compared to (ii) the gap between the bottom of the magnetic 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.

[0121] In some embodiments, the outer diameter of the magnetic 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. Accordingly, in some embodiments, the radial gap 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, 0.6 mm to 0.7 mm, but is not limited thereto.

[0122] Blood flows toward the pump rotor 132, through the central bore 134, and radially outward from the pump rotor 132 by rotation of the vanes 135. Referring again to FIG. 1, the blood flows through the annular space 128 defined by the pump housing 130 and / or the arterial end cap 120. Figure 13 and 23 As the blood flows generally radially away from the pump rotor 132, the blood enters the 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 turn by the inner wall of the pump housing 130 and flow parallel to the longitudinal axis Z of the dialyzer 100 toward the bundle of hollow fibers 114.

[0123] In some embodiments, the diameter of the annular space 128 is greater than the diameter of the cylindrical inner wall of the pump housing 130 (including the magnetic disk 136) by a range of 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, but is not limited thereto.

[0124] The first end cap 120 includes an internal support plate 121. The rotor supply tube 103 can 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 while defining a plurality of openings (e.g., slots, circular openings, etc.) 123 therebetween. The openings / slits 123 provide a passageway for blood to flow from the pump housing 130 to the bundle of hollow fibers. In the illustrated embodiment, there are four arcuate slots 123 through which blood can flow. In some embodiments, there is a single opening / slit 123, or two openings / slits 123, three openings / slits 123, four openings / slits 123, five openings / slits 123, six openings / slits 123, seven openings / slits 123, eight openings / slits 123, or more than eight openings / slits 123.

[0125] Blood is pushed through the interior space (or lumen) of each hollow fiber of the bundle of hollow fibers 114 due to the increased pressure created by the rotating pump rotor 132. Blood enters the fibers via openings exposed on the surface of the potting 115. Because the potting 115 is sealed relative to the arterial end cap 120, the pressurized blood is forced through the lumens of the hollow fibers of the bundle of hollow fibers 114 that pass through and are supported by the potting 115. In this example, the potting 115 is sealed relative to the arterial end cap 120 by a gasket 170 that is compressed axially (i.e., in the direction of the longitudinal axis Z) between the outer periphery of the potting 115 and the inner wall of the arterial end cap 120. A second gasket 171 serves a similar function relative to the venous end cap 140 and the potting 116.

[0126] As the blood flows axially through the lumens of the bundle of hollow fibers 114, dialysis occurs across the semi-permeable fiber membranes, with dialysate flowing in the space around the fibers 114 (in a counter-current direction). The blood at this point is still flowing within the hollow fibers 114, through the second potting 116 in the venous end cap 140, and into the interior space 146 in the upper cap 145 of the venous end cap 140.

[0127] Again, when the dialyzer 100 is in use, dialysate flows from the venous end cap 140 to the arterial end cap 120 along the outer surfaces of the hollow fibers 114, for example, within the spaces defined between the hollow fibers 114. If a flow rate measurement of the dialysate is taken at various points along a cross-section that is 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 perfectly uniform. That is, in many cases, it can be seen that the flow rate of the dialysate is higher near the outer regions of the bundle of hollow fibers 114 than in the inner regions of the bundle of hollow fibers 114. In other words, more dialysate tends to flow through the dialyzer 100 along the outer annular portions of the bundle of hollow fibers 114 than through the central portions of the bundle of hollow fibers 114.

[0128] In view of the non-uniform flow rate of the dialysate as described above, the arterial end cap 120 is advantageously designed to direct blood to 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 slot 123 through which blood is directed to flow en route to the bundle of hollow fibers 114. The radial position of the arcuate slot 123 is biased toward the outer annular portions of the bundle of hollow fibers 114 (as compared to the central portions of the bundle of hollow fibers 114). Thus, the arterial end cap 120 causes blood to flow through the outer annular portions of the bundle of hollow fibers 114 at a higher rate than the central portions of the bundle of hollow fibers 114 in a manner that advantageously matches the higher flow rate regions of the dialysate. This matching of the flow rate profiles of the blood and dialysate advantageously enhances dialysis efficiency as compared to having different flow rate profiles for the blood and dialysate.

[0129] The arterial end cap 120 is also advantageously designed to reduce the likelihood of hemolysis (damage to red blood cells) of the blood. As described above, blood exiting the rotor 132 flows generally radially from the vanes 135 into the annular space 128. However, due to the rotation of the rotor 132, the blood within the annular space 128 also has a tendency to flow in a generally circular fashion (e.g., like a vortex). If the blood is forced to flow into the lumens of the hollow fibers 114 while still flowing in a substantially circular fashion, the resulting dynamic shear stress will tend to cause hemolysis. Fortunately, the interior support plate 121 of the arterial end cap 120 is designed to reduce the circular flow of the blood, thereby reducing the likelihood of hemolysis. For example, the arcuate slots 123 through which the blood is directed to flow in the path of the bundle of hollow fibers 114 reduce the circular flow of the blood. Instead, the arcuate slots 123 cause the blood to flow more axially toward the entrance of the lumens of the hollow fibers 114. Thus, by reducing the circular flow of the blood as it enters the lumens of the hollow fibers 114, the arcuate slots 123 of the interior support plate 121 reduce the likelihood of dynamic shear stress of the blood and reduce the likelihood of hemolysis.

[0130] As described above, the pump rotor 132 defines a central cavity 131. The central cavity 131 extends through the pump rotor 132 from the region of the vanes 135 and all the way through the magnetic disk 136. In other words, the central cavity 131 provides fluid communication between the region of the vanes 135 and the gap between the cylindrical outer wall of the pump rotor 132 and the cylindrical inner wall of the pump housing 130. With the fluid communication provided by the central cavity 131, the likelihood of blood stagnating in the region of the pump housing 130 is reduced. That is, the central cavity 131 helps move the blood in the gap between the cylindrical outer wall of the pump rotor 132 and the cylindrical inner wall of the pump housing 130 and out therefrom. Thus, due to the central cavity 131 of the pump rotor 132, the likelihood of thrombus formation in the pump housing 130 is reduced.

[0131] Reference is also made to Figure 25 An alternative pump rotor 137 includes a first plate 138, a magnetic disk 143, and a plurality of vanes 139 extending radially between the first plate 138 and the magnetic disk 143. The first plate 138 is annular and defines a central aperture 141. The magnetic disk 143 can include unencapsulated or encapsulated dipole magnets (e.g., rare earth magnets, ferrite ceramic magnets, and other suitable types of magnets). In the illustrated embodiment, the vanes 139 are linear members.

[0132] According to some embodiments, the pump rotor 137 is a pump impeller that includes a radial pumping impeller with a hollow central volume region. Thus, the illustrated pump rotor 137 can also be referred to as a pump impeller. The blades (or vanes) of the impeller of the pump rotor 137 can be arranged so that they at least partially project or extend radially. 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.

[0133] Blood flows to the pump rotor 137, through the central bore 141, and is then forced to move radially outward from the pump rotor 137 due to the rotation of the blades 139. As the blood flows radially away from the pump rotor 137, the blood is forced to turn and flow parallel to the longitudinal axis of the dialyzer 100 (toward the bundle of hollow fibers) by the action of the inner wall of the pump housing 130. The blood then passes through the slots 123 defined between the inner support plate 121 and the inner wall of the first end cap 120. The slots 123 provide a passageway for the blood to flow from the pump housing 130 to the bundle of hollow fibers.

[0134] Referring Figures 27 to 29 to FIG. 2, the venous end cap 140 (or “second end cap 140”) is shown separately from other portions of the dialyzer 100, so that the structural details of the second end cap 140 are more visible.

[0135] As shown, for example, in FIG. 2, the blood that has passed through the bundle of fibers 114 in the dialyzer 100 and into the second end cap 140 exits the upper dome 145 via the blood outlet tube 105. Figure 13 and Figure 14 As shown, for example, in FIG. 2, the blood that has passed through the bundle of fibers 114 in the dialyzer 100 and into the second end cap 140 exits the upper dome 145 via the blood outlet tube 105.

[0136] The second end cap 140 also includes an air purge 144. The air purge 144 can be located at the apex of the upper dome 145. The air purge 144 can serve multiple purposes, for example, to purge air (vent gas) as well as to serve as an access port (for example, for sample extraction or drug administration). Figure 29 A cross-sectional view of another example venous end cap 340 is shown, which differs from the end cap 140 in that, in addition to an air purge 344, the end cap 340 also includes an access port 380 (in this case, a needleless inlet). The access port 380 can be used to administer a drug or to extract a sample.

[0137] Blood enters the venous pressure sensing chamber 142 (with its outer, flexible membrane wall 162) from the blood outlet tube 105 via the venous pressure sensing chamber inlet 142i. Blood exits the venous pressure sensing chamber 142 via the venous pressure sensing chamber outlet 142o. The flow of blood through the venous pressure sensing chamber 142 allows the venous pressure transducer 252 of the blood treatment module 220 (shown in FIG. 1) to measure the venous blood pressure via the membrane 162. Figure 31 As shown in FIG. 1, the blood treatment module 220 includes a venous pressure transducer 252. The venous pressure transducer 252 is configured to measure the pressure of blood in the venous pressure sensing chamber 142. The venous pressure transducer 252 is configured to output a signal indicative of the pressure of blood in the venous pressure sensing chamber 142. The signal output by the venous pressure transducer 252 can be used to determine the pressure of blood in the venous pressure sensing chamber 142.

[0138] After exiting the venous pressure detection chamber 142, the blood then flows into the venous mixing chamber 164. The blood can pass through the venous mixing chamber 164 without post-dilution, or can be mixed with replacement fluid, such as when the blood treatment system 1 is operated in post-dilution HDF mode.

[0139] In the case of replacement addition to the venous mixing chamber (e.g., post-dilution HDF), the replacement flows from the second replacement supply conduit 256 (shown in Figure 31 ) into the second end cap 140 via the second replacement inlet 148. The replacement flows through the venous replacement supply tube 166. The replacement then passes through the check valve 168 and into the venous mixing chamber 164. This flow of replacement is shown in Figure 15 by a series of arrows extending from the second replacement inlet 148 to the outlet of the check valve 168 in the second end cap 140. In the venous mixing chamber 164, the replacement mixes with the venous blood entering from the venous pressure detection chamber 142. The check valve 168 prevents blood from flowing into the venous replacement supply tube 166 and the second replacement inlet 148. This prevents the second replacement supply conduit 256 from being contaminated with blood.

[0140] The blood (whether or not it is diluted) passes from the venous mixing chamber 164 into the venous blood line 104, which transports the dialyzed blood back into the patient.

[0141] The second end cap 140 also includes a dialysate inlet 149. Dialysate flows from the dialysate inlet 149 to the perimeter inner wall region of the second end cap 140 by way of a dialysate supply tube 150.

[0142] The flow path of dialysate from the dialysate supply conduit 257 to the dialysate outlet conduit (or waste dialysate conduit) 255 is shown in Figures 17 to 19 The blood treatment module 220 is actuated to: a) fluidly sealably engage the dialysate supply conduit 257 (shown in Figure 31 ) with the dialysate inlet 149, and b) fluidly sealably engage the waste dialysate conduit 255 with the waste dialysate outlet 125. Flow of dialysate then begins as the dialysate flows through the dialysate supply tube 150 into the space between the venous end cap 140 and the potting 116. The dialysate flows axially through the potting 116 from this space, and radially inwardly through the openings 118 between the axially extending fingers 174 of the intermediate housing portion 112. The ends of the fingers 174 embed in and support the potting 116. The dialysate path is isolated from the blood volume in the venous end cap 140 by the gasket 171.

[0143] Radial inflow of dialysate through the openings 118 (with the aid of the fingers 174 to help distribute the dialysate flow) causes the dialysate to flow in a circumferential manner as it flows between the spaces between the hollow fibers 114. This circumferential concentrated dialysate flow is adapted or aligned with the flow of blood through the interior lumens of the hollow fibers 114, as the blood enters the hollow fibers 114 through the openings / slits 123 located around the perimeter of the first end cap 120. Thus, the design of the dialyzer 100 matches the highest flow concentrations of dialysate and blood in the area of the hollow fibers 114 to each other. This matching of blood and dialysate flow concentrations improves the efficiency of the blood treatment of the dialyzer 100.

[0144] After passing through the openings 118, the dialysate flows between the hollow fibers 114 and continues to flow axially downward until reaching the arterial end cap 120. As the potting 115 prevents further axial flow between the fibers 114, the dialysate flows radially outward through the openings 117 between the fingers 173 of the middle housing portion 112 that embed and support the potting 115. The dialysate path is isolated from the blood volume in the arterial end cap 120 by the gasket 170. The dialysate then flows into the space between the arterial end cap 120 and the potting 115. The dialysate then enters the spent dialysate outlet tube 126 via the spent dialysate tube inlet 127. The spent dialysate tube 126 then transports the dialysate to the dialysate outlet, where it flows into the spent dialysate conduit 255 (shown in FIG. 2) of the blood treatment module 220. Figures 31 to 33

[0145] Referring to Figure 30 and Figure 31 , the treatment module 220 defines a first complementarily shaped slot 222 and a second complementarily shaped slot 224 that configure the treatment module 220 to be slidably couplable with the first protrusion 106 and the second protrusion 108 (e.g., the Figure 2 、 Figure 10 and Figure 17 ) of the dialyzer 100. The treatment module 220 also includes an arterial line clamp 242 and a venous line clamp 244. The clamps 242 and 244 are used to completely restrict or completely unrestricted flow of blood within the arterial line 102 and / or the venous line 104 (e.g., in an on / off valve 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).

[0146] ​The therapy module 220 also includes a tube engagement module 240 configured to releasably receive a portion of the arterial line 102 and / or a portion of the venous line 104. The tube engagement module 240 can include devices that perform functions such as flow rate detection, bubble detection, etc. That is, the tube engagement module 240 can include sensors for detecting a flow rate of blood within, for example, 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 can be performed using sensors such as ultrasonic sensors, optical sensors, or other suitable types of sensors.

[0147] The therapy module 220 also includes a pump drive unit 230. The pump drive unit 230 is configured to releasably receive the pump housing 130 (shown in Figure 8 、 Figure 9 、 Figure 13 and Figure 15 ) of the dialyzer 100 when the dialyzer 100 is coupled to the therapy module 220. During operation of the therapy module 220, one or more electric coils within the pump drive unit 230 are dynamically energized by a control system of the hemodialysis machine console 210 (shown in Figure 1 ). Energization of the one or more electric coils generates a dynamic magnetic field (a moving or modulated magnetic field) that causes a magnetic pump rotor (e.g., the rotor 132 or the rotor 137) to levitate without contacting the walls of the pump housing 130 and to rotate at a desired rotational speed. Alternatively, in some embodiments, a mechanical coupling can be used to couple the pump drive unit to the pump rotor within the dialyzer.

[0148] The pump drive unit 230 in combination with the control system of the hemodialysis machine console 210 (shown in Figure 1 ) can also be used to monitor various states of the dialyzer 100. For example, it can be detected whether the pump housing 130 of the dialyzer 100 is in an operational position relative to the pump drive unit 230. In addition, the presence of air in the pump housing 130 can be detected. If air is detected within the pump housing 130, a displacing substance can be added via the first displacing liquid port 124 to prime the magnetic pump rotor. Obstructions within the dialyzer 100 can also be detected by the pump drive unit 230 in combination with its control system.

[0149] The therapy module 220 also includes pressure measurement devices that engage the dialyzer 100 to measure the arterial pressure detection chamber 122 and the venous pressure detection chamber 142 (shown in Figure 8 、 Figure 11 、 Figure 12 、 Figure 18 and Figure 19The pressure measurement devices and tubing can be controlled by the therapy module 220 to extend to engage with the dialyzer 100, and to retract to disengage from the dialyzer 100.

[0150] In Figure 30 , the pressure measurement devices and tubing are retracted and covered by the first door 246 and the second door 248. In Figure 31 , the doors 246 and 248 are opened and the pressure measurement devices and tubing are extended (as they are to engage with the dialyzer 100). When closed, the doors 246 and 248 allow for convenient wiping to clean the exterior surface of the therapy module 220. Additionally, with the pressure measurement devices and tubing retracted to the interior within the therapy module 220 (and the doors 246 and 248 closed), the pressure measurement devices and tubing can be automatically cleaned and prepared for later use when they are within the therapy module 220.

[0151] In Figure 31 , the doors 246 and 248 are in their open position and the pressure measurement devices and tubing are extended to their operational positions (as if the dialyzer 100 were coupled with the therapy module 220). For example, the first pressure transducer 250 is extended to engage with the flexible membrane wall of the arterial pressure sensing chamber 122 of the dialyzer 100, and the second pressure transducer 252 is extended to engage with the flexible membrane wall of the venous pressure sensing chamber 142 of the dialyzer 100.

[0152] Additionally, the therapy module 220 includes two pairs of tubing that can automatically engage with the dialyzer 100 to facilitate the flow of liquids, such as replacement fluid and / or dialysate, between the dialyzer 100 and the therapy module 220. For example, a first pair of tubing (a first replacement fluid supply tubing 254 and a dialysate outlet tubing 255) is positioned to couple with the first replacement fluid port 124 and the dialysate outlet 125, respectively, located on the first end cap 120 of the dialyzer 100. Additionally, a second pair of tubing (a second replacement fluid supply tubing 256 and a dialysate supply tubing 257) is positioned to couple with the second replacement fluid port 148 and the dialysate inlet 149, respectively, located on the second end cap 140 of the dialyzer 100. The extension and retraction of the tubing 254-257 and the pressure measurement transducers 250 and 252 can be controlled by the control system of the blood treatment machine 200 Figure 1 ).

[0153] Referring to Figures 32 to 34, providing a separate view showing more detail of how the first end cap 120 interfaces with the first pressure transducer 250, the first replacement supply conduit 254, and the dialysate outlet conduit 255. It will be appreciated that the relative arrangement of the second end cap 140 with respect to the second pressure transducer 252, the second replacement supply conduit 256, and the dialysate supply conduit 257 is similar.

[0154] The face of the first pressure transducer 250 (when extended, as shown) abuts a flexible membrane 122m that serves as an outer wall of the arterial pressure detection chamber 122. The first replacement supply conduit 254 (when extended, as shown) is fluidly coupled in a liquid-tight manner with the first replacement fluid port 124. The dialysate outlet conduit 255 (when extended, as shown) is fluidly coupled in a liquid-tight manner with the dialysate outlet 125. Figure 24 Figure 24 Figure 24

[0155] To provide an effective interface between the flexible membrane 122m and the first pressure transducer 250, the arterial pressure detection chamber 122 is pressurized prior to extending the first pressure transducer 250 into contact with the flexible membrane 122m. When the arterial pressure detection chamber 122 is pressurized, the flexible membrane 122m will bulge outward to present a convex surface to the first pressure transducer 250. Then, when the flexible membrane 122m bulges outward, the first pressure transducer 250 is extended to abut the flexible membrane 122m to seal the interface therebetween. This technique can help establish a strong coupling adhesion between the first pressure transducer 250 and the flexible membrane 122m, for example, by reducing the likelihood of air pockets therebetween. In some embodiments, a negative air pressure (vacuum) can be applied to create or enhance the coupling adhesion between the first pressure transducer 250 and the flexible membrane 122m.

[0156] Figure 35 Another example blood treatment module 1220 and dialyzer 1100 is shown. This arrangement differs from that of the module 220 and dialyzer 100 in that the dialysate and replacement ports, as well as the pressure chambers and membranes, are located in the arterial end cap. Thus, the blood treatment module 1220 interfaces only with the arterial end cap 1120 to supply fresh dialysate, receive spent dialysate, supply pre- and post-dilution replacement fluid, and monitor arterial and venous pressures. In this arrangement, a pair of tubes 1190 are provided to transport fresh dialysate and post-dilution replacement from the arterial end cap 1120 to the venous end cap 1140.

[0157] Figure 36 is a perspective view of an alternative first (arterial) end cap 520 shown in partial longitudinal section. The end cap 520 can be used with the dialyzer 100, for example, as a replacement for the end cap 120.

[0158] ​​​Incoming blood flows through a rotor supply tube 503 supported by an internal support plate 521 towards the pump housing 530. A 90° bend at the end of the rotor supply tube 503 directs the blood to turn and flow parallel to the longitudinal center axis of the dialyzer 100 along the center of the first end cap 520. Blood is delivered from the outlet of the rotor supply tube 503 to the center of a pump rotor 532 located within the pump housing 530. Blood exits the pump rotor 532 radially into an annular space 528 that circumferentially surrounds a portion of the rotor 532 that includes vanes 535. The annular space 528 is shaped to direct the blood axially towards the bundle of hollow fibers. The annular space 528 is partially defined by an annular concave wall surface of the housing 530 that opposes the bundle of hollow fibers. After redirection from radial flow 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 towards the bundle of hollow fibers. In some embodiments, the openings 523 are slots (e.g., linear or arcuate slots). Any number of openings 523 can be included, such as one, two, three, four, five, six, seven, eight, or more than eight.

[0159] The pump rotor 532 includes a first end 537 and a second end 538 on opposite ends of the pump rotor 532. The first end 537 houses 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 vanes 535 extending between the first plate 533 and the magnetic disk 536. The first end 537 is smaller in diameter than the second end 538.

[0160] According to some embodiments, the pump rotor 532 is a pump impeller that includes a radial pumping impeller wheel having a hollow central volume region. Thus, the illustrated pump rotor 532 can also be referred to as a pump impeller. The vanes 535 of the impeller wheel (second end 538) of the pump rotor 532 can be arranged such that they at least partially project or extend radially. In some cases, the vanes are arranged to project or extend entirely radially. In some cases, the vanes are arranged to project or extend partially radially and partially tangentially. The first plate 533 is an annular ring that defines a central bore 534. The magnetic disk 536 defines a central cavity 531 that extends along the longitudinal center axis Z of the dialyzer 100. The magnetic disk 536 can include one or more encapsulated or unencapsulated dipole magnets (e.g., rare earth magnets, ferrite magnets, ceramic, and other suitable types of magnets). In the illustrated embodiment, the vanes 535 are arcuate, but in some embodiments, the vanes 535 can be linear.

[0161] In some embodiments, the components of end cap 520 can have the same physical dimensions and dimensional relationships as described above with reference to the components of end cap 120. However, end cap 520 differs from end cap 120 in at least the following ways. The outer edge of vane 535 is not parallel to the central axis. Rather, an acute angle is defined between the outer edge of vane 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. Further, in some embodiments, the height of vane 535 is less than the height of vane 135. For example, in some embodiments, the height of vane 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. Further, annular space 528 differs in shape from annular space 128. For example, the inner surface of the housing that defines the lower wall of annular space 528 is concave (curved downward), whereas the lower surface of annular space 128 is planar or curved upward. The shape of annular space 528 promotes the development of vortices in the flow that exits radially from pump rotor 532 and promotes the transition (re-direction) of the flow toward an upward axial direction.

[0162] These physical features of end cap 520 and its pump rotor 532 serve to maximize the axial thrust of the blood flow and stabilize pump rotor 532 during operation. In essence, pump rotor 532 and annular space 528 redirect the blood flow by 180° rather than 90°. In some embodiments, blood is introduced axially into the "top" of pump rotor 532 and is delivered to the "bottom" of rotor 532.

[0163] Blood exits end cap 520 via one or more openings 523 in a circular pattern concentric with central bore 534. The one or more openings 523 can be a plurality of holes in a symmetric circular arrangement, or one or more circular / arc segment shaped slits. Thus, there is no eccentric force acting on pump rotor 532 (unlike most centrifugal pumps with tangential outlets). As a result, pump rotor 532 is more stable during operation (e.g., has a significantly reduced tilting moment) and the dimensional clearance between it and the surrounding housing surface is maintained within tolerance. Advantageously, because pump rotor 532 is more stable during operation, the magnetic field strength required to levitate and drive pump rotor 532 is reduced. Thus, for example, in some embodiments, a less expensive hard ferrite magnet can be used, thereby greatly reducing the cost of pump rotor 532.

[0164] The shape of the annular space 528 facilitates the transition (re-direction) of blood flow from a radial to an axial direction upward. The upward blood flow from the annular space 528 is substantially concentrated at the periphery or circumference of the outlet of the annular space 528. This concentration of blood flow is also advantageously adapted to the location of the openings 523 (which in turn is adapted to the peripheral portion of the bundle of hollow fibers). Moreover, as described above with reference to Figures 17 to 19 the dialysate radially flows into the space between the hollow fibers 114, the flow of dialysate is concentrated in a circumferential annular manner. The peripherally concentrated dialysate flow is adapted or coincides with the peripherally concentrated blood flow through the lumens of the hollow fibers 114. Thus, the design of the dialyzer 100 advantageously causes or matches the highest flow of dialysate and blood in the same region to each other. This matching of blood and dialysate flow concentration improves the efficiency of the blood treatment of the dialyzer 100.

[0165] While certain embodiments have been described, other embodiments are possible and within the scope of the disclosure.

[0166] While a system with HDF functionality is described, certain embodiments omit the substitution port. Such a machine can perform hemodialysis, but does not include HDF functionality. For example, a dialyzer configured similar to the blood treatment system of Figure 1 The dialyzer 2100 of the dialyzer 2100 is shown in Figure 37 - Figure 39 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 a majority of the length of the bundle of hollow fibers 2114.

[0167] 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 described further herein, the pump rotor is operated and controlled by engagement with a pump drive unit (e.g., as shown in Figure 2 and Figure 3 ). That is, during use, the pump rotor can be levitated and rotated by a magnetic field emitted from the pump drive unit.

[0168] The housing 2110 defines one or more pressure detection chambers. The illustrated embodiment includes an arterial pressure detection chamber 2122 and a venous pressure detection chamber 2142. The arterial pressure detection chamber 2122 is located before the pump rotor. That is, the arterial pressure detection chamber 2122 is arranged to facilitate measurement of pre-pump arterial pressure. Additionally or alternatively, in some embodiments, pressure can be measured post-pump (but before the hollow fibers). Both the pressure detection chambers 2122 and 2142 are configured to interface with corresponding pressure transducers in the treatment module 220.

[0169] The dialyzer 2100 is configured to receive dialysate and direct the dialysate to flow through the housing 2110. For example, in the illustrated embodiment, the second end cap 2140 defines a dialysate inlet 2149 and the 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 the middle housing portion 2112 containing the bundle of hollow fibers 2114. The dialysate flows through the middle housing portion 2112 via the spaces defined between the outer diameters of the fibers of the bundle of hollow fibers 2114. In other words, as blood flows within the lumens of the fibers of the bundle of hollow fibers 2114, dialysate flows along the outside 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 middle housing portion 2112 and into the first end cap 2120. The dialysate exits the first end cap 2120 via the dialysate outlet 2125.

[0170] Referring to Figure 40 and Figure 41 , an alternative second (venous) end cap 600 can be used with any of the dialyzers described herein. The venous end cap 600 is configured with certain features to facilitate separation of gases, such as air, from the extracorporeal circuit during priming and during use. The venous end cap 600 includes a spiral inlet chamber 610 (or spiral chamber 610), an outlet 620, a sloped flow director 630, a top cap 640, an air purge 650, and a chamber 660. In Figure 41 the top cap 640 and the air purge 650 are not shown to provide better visibility of the structure inside the chamber 660. The upper portion of the venous end cap 600 includes the top cap 640 and the attached air purge 650. The lower or bottom portion of the venous end cap 600 defines the spiral inlet chamber 610 and its outlet 620 and includes the sloped flow director 630. The spiral inlet chamber 610 and the sloped flow director 630 can be integrally formed with the lower portion of the venous end cap 600. The outlet of the spiral inlet chamber 610 is located between the upper portion of the venous end cap 600 and the outlet 620 of the chamber 660.

[0171] In use, blood exits the lumen of the hollow fibers and flows to the chamber 660 via the inlet to the spiral inlet lumen 610 and through the spiral inlet lumen 610 itself. In other words, the spiral inlet lumen 610 provides fluid communication between the chamber 660 and the region outside of the chamber 660. The inlet to the spiral inlet lumen 610 is configured on the bottom side of the bottom of the venous end cap 600. The inlet to the spiral inlet lumen 610 has a larger area than the lateral cross-section of the spiral inlet lumen 610. The outlet of the spiral inlet lumen 610 is configured on the upper side of the bottom. The spiral inlet lumen 610 extends from the lower portion of the venous end cap 600 and spirals vertically towards the upper portion of the venous end cap 600 (towards the top cap 640). The spiral inlet lumen 610 is configured such that blood entering the chamber flows substantially horizontally (i.e., transverse to the longitudinal axis of the dialyzer). The outlet of the spiral inlet lumen 610 (i.e., the location at which the spiral inlet lumen 610 terminates within the chamber 660) is proximate to the peripheral wall of the chamber 660. In other words, the outlet of the spiral inlet lumen 610 is offset from the central axis of the dialyzer and the central axis of the venous end cap 600 itself. Thus, blood flowing into the chamber 660 can tend to impinge on the peripheral wall of the chamber 660, which will create a spiral flow path for the blood.

[0172] The angled flow director 630 is located proximate to the outlet of the spiral inlet lumen 610, such that blood exiting the spiral inlet lumen 610 will tend to impinge on the angled flow director 630 and deflect upwards towards the top cap 640, which is a rigid portion of the housing such that it defines a fixed shape of the upper portion of the chamber 660. The impingement surface of the angled flow director 630 can be at an acute angle relative to the direction of the substantially horizontal blood flow as the blood exits the spiral inlet lumen 610. For example, in some embodiments, the angle of the angled flow director 630 relative to horizontal and / or relative to the central longitudinal axis of the dialyzer and the 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.

[0173] The air purge 650 allows air and other gases to exit the venous end cap 600 while preventing fluids such as blood from exiting therethrough. The air purge 650 can also be used as an access port. That is, the air purge 650 can be configured for uses such as sample extraction and drug (e.g., heparin) administration.

[0174] To function optimally as an air separator during use, it is desirable to substantially clear the air within the venous end cap 600 prior to the initiation of blood treatment by priming. That is, it is desirable to clear sufficient air from the chamber 660 during the priming phase to enable the chamber 660 to optimally, effectively separate air subsequently during blood treatment. During priming, it is intended that the air in the chamber 660 be substantially flushed out of the chamber 660 by the priming solution. By virtue of the velocity and directional flow created by the structure of the venous end cap 600, the ability of the priming solution to remove air from the chamber 660 is enhanced (e.g., by flushing the air out through a flush port positioned on the blood treatment machine). Otherwise, air remaining in the chamber 660 can also be manually cleared via the air purge 650 by connecting a syringe to the air purge 650.

[0175] During use, the flow rate created by the structure of the venous end cap 600 presents a challenge to air separation, as air in the blood needs time to be affected by gravity and can still remain entrained in the blood. The structure of the venous end cap 600 induces a circular, spiral flow, which can act to slow the velocity of the blood flow. As a result, air tends to migrate toward the center of the spiral flow, where the velocity is lowest, and gravity has time to act on the air, so the air can separate from the blood and collect at the top of the top cap 640.

[0176] Although the structure of the venous end cap 600 for de-aerating a liquid is described above in the context of an end cap for a dialyzer, it should be understood that the structure for de-aeration can also be used in conjunction with various other types of devices, or incorporated into itself as a de-aeration device. That is, the structure for de-aerating of the venous end cap 600 can be implemented as part of a de-aeration chamber that can be implemented in a variety of suitable embodiments. Additionally, although the venous end cap 600 is primarily intended for de-aerating blood, priming solution, or other medical liquids, it should be understood that the structure for de-aerating of the venous end cap 600 can also be implemented in other embodiments in order to de-aerate other types of liquids.

[0177] Reference Figures 42 to 44 , another alternative second (venous) end cap 700 can be used with any of the dialyzers described herein. The venous end cap 700 is configured with certain features to facilitate the separation of gases, such as air, from the extracorporeal circuit during priming and during use.

[0178] The venous end cap 700 includes an upper or top portion that includes a top cap 710 and an attached air purge 730 (shown in Figure 43 , but not shown in Figure 42 and 44 ). The venous end cap 700 includes a lower or bottom portion that includes an inlet passage 740 and defines a chamber outlet 750Figure 44 A chamber 720 is defined between the upper and lower portions of the venous end cap 700.

[0179] The inlet passage 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 passage 740 can be integrally formed with the lower portion of the venous end cap 700. The outlet of the inlet passage 740 is at the end of the protrusion that is elevated above the chamber outlet 750 and elevated above the mid-height of the chamber 720. The outlet of the inlet passage 740 is radially offset from the central axis (e.g., longitudinal axis) of the venous end cap 700 (and the entire dialyzer). The top cover 710 is a rigid upper portion of the housing such that it defines a fixed shape of the upper portion of the chamber 720.

[0180] Blood that has been treated by the hollow fiber membranes enters the chamber 720 of the venous end cap 700 through the inlet passage 740 formed in the axial middle of the venous end cap 700. The outlet end at the end of the inlet passage 740 is configured to be helical (e.g., have a slope at an acute angle relative to the central axis along which blood exiting the inlet passage 740 will flow). Thus, the outlet end at the end of the inlet passage 740 is configured to impart a helical component to the flow path of the blood as it exits the inlet passage 740 into the chamber 720. After spilling out of the end outlet of the inlet passage 740, the blood enters the chamber 720. The blood can be degassed by gravity (bubbles will tend to rise relative to the blood and separate from the blood) as the blood flows in a thin layer and from the end of the inlet passage 740 in a helical flow into the chamber 720 and toward the chamber outlet 750.

[0181] Although the intermediate inlet passage 740 in the illustrated embodiment includes only one helical passage outlet (into the chamber 720) of the inlet passage 740, in some embodiments, the inlet passage 740 can also include multiple helical passage outlets. In some of these embodiments, the multiple helical passage outlets can be symmetrically or evenly distributed about the venous end cap 700 in order to minimize turbulence in the blood and symmetrically balance the flow within the chamber 720.

[0182] While the structure of the venous end cap 700 for de-aerating a liquid is described above in the context of an end cap of a dialyzer, it should be understood that the structure for de-aerating can be used in conjunction with various other types of devices, or incorporated into itself as a de-aeration device. That is, the structure for de-aerating of the venous end cap 700 can be part of a de-aeration chamber that can be implemented in a variety of suitable implementations. Additionally, while the venous end cap 700 is primarily intended for de-aerating blood, a priming solution, or other medical liquids, it should be understood that the structure for de-aerating of the venous end cap 700 can be implemented in other embodiments to de-aerate other types of liquids.

[0183] Reference is made 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 particular features to facilitate the separation and collection of gases, such as air, from an extracorporeal circuit. For example, the venous end cap 800 includes a reconfigurable poppet cap, as described further below.

[0184] The venous end cap 800 includes one or more peripheral inlets 810 (or a plurality of peripheral inlets 810), an outlet 820, a reconfigurable top cap 840 (or a flexible top cap), an air purge 850, and a chamber 860. In Figure 47 , the top cap 840 and the air purge 850 are not shown to provide better visibility of the structure inside the chamber 860. In Figure 45 , the reconfigurable top cap 840 is in a first, inverted configuration such that the chamber 860 is substantially non-existent or only minimally present. In Figure 46 , the reconfigurable top cap 840 is in a second, domed configuration, thereby defining the chamber 860. The chamber 860 is larger when the reconfigurable top cap 840 is in the second configuration as compared to the first configuration.

[0185] The one or more peripheral inlets 810 are passages that allow liquid exiting the hollow fibers of a dialyzer to enter the chamber 860. After entering the chamber 860, the liquid resides in the chamber 860 for a period of time before exiting the chamber 860 via the outlet 820. The outlet 820 is in a sidewall of the lower portion of the housing and is lower in height than the one or more peripheral inlets 810. In other words, the outlet 820 is on an opposite side of the one or more peripheral inlets 810 as compared to the reconfigurable top cap 840 when the reconfigurable top cap 840 is in the second, domed configuration.

[0186] In some embodiments, the outlet 820 is positioned elsewhere. For example, in some embodiments, the outlet 820 is positioned in the center and at the bottom of the concave lower portion of the chamber 860, as Figure 47The one outlet 820' is shown. In this position, the outlet 820' is surrounded by the one or more perimeter inlets 810 and is equidistant from each of the one or more perimeter inlets 810. In some embodiments, multiple outlets are included. For example, in some embodiments, the outlet 820 and the outlet 820' are included in a single embodiment, respectively.

[0187] In some embodiments, a plurality of perimeter inlets 810 (e.g., six in the illustrated embodiment) that are spaced apart from one another surround a periphery of the chamber 860. Doing so allows for a low velocity of liquid (e.g., a priming solution, blood, etc.) into the chamber 860. By maintaining a low liquid flow velocity in the chamber 860, more time allows air to rise (i.e., separate) from the liquid due to the effects of gravity. However, using this low velocity approach tends to make it more difficult to flush air from a traditional chamber in a traditional end cap during a priming phase. The particular pop-off cap (i.e., the reconfigurable top cap 840) of the venous end cap 800 helps to alleviate this issue.

[0188] The reconfigurable top cap 840 (or flexible top cap 840) is a semi-spherical piece made of a semi-flexible material. The natural, stress-minimized configuration of the reconfigurable top cap 840 is Figure 46 the illustrated shape (dome shape, cambered configuration, or second configuration). The second configuration (dome shape) of the reconfigurable top cap 840 is more stable than the first configuration (inverted configuration). However, the reconfigurable top cap 840 will also maintain its Figure 45 inverted configuration as illustrated. The inverted configuration is the initial configuration of the reconfigurable top cap 840 (i.e., the configuration of the reconfigurable top cap 840 prior to priming or use). In response to pressurization within the chamber 860, the reconfigurable top cap 840 (or flexible top cap 840) will reconfigure from the first configuration (inverted configuration) to the second configuration (dome configuration).

[0189] During priming, as liquid passes through the one or more inlets 810, the liquid will exert a force to the inner surface of the inverted reconfigurable top cap 840. The reconfigurable top cap 840 will begin to deflect upward in response to the force of the liquid, and the chamber 860 will thereby begin to form. When the reconfigurable top cap 840 has deflected upward to a threshold extent, the reconfigurable top cap 840 will naturally tend to change or pop out to the Figure 46 dome configuration as illustrated. Advantageously, because there is substantially no or only minimal chamber 860 present during initial priming, there is substantially no air that needs to be flushed out by the liquid priming process. However, after the chamber 860 has formed, the chamber 860 is used to separate air / gas from blood during use.

[0190] While the structure for de-aeration of the venous end cap 800 is described above in the context of an end cap of a dialyzer, it should be understood that the structure for de-aeration can be used in conjunction with various other types of devices, or incorporated into itself as a de-aeration device. That is, the structure for de-aeration of the venous end cap 800 can be part of a de-aeration chamber that can be implemented in a variety of suitable embodiments. Additionally, while the venous end cap 800 is primarily used for de-aeration of blood, priming solution, or other medical liquids, it should be understood that the structure for de-aeration of the venous end cap 800 can be implemented in other embodiments for de-aeration of other types of liquids.

[0191] Various different types of dialyzer venous end caps are described above having structures for de-aeration of liquids (e.g., the venous end cap 600, the venous end cap 700, and the venous end cap 800). 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 that are within the scope of the present disclosure. For example, while the venous end cap 800 is described as having a reconfigurable top cap 840, in some embodiments, a rigid / fixed top cap (e.g., the top cap 640 or the top cap 710) can also substitute for the reconfigurable top cap 840. Conversely, while the venous end cap 600 and the venous end cap 700 are described as having rigid / fixed top caps, in some embodiments, a reconfigurable top cap (e.g., the reconfigurable top cap 840) can substitute for 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. By way of these examples, it should be understood that all possible hybrid designs using features of the various venous end caps 600, 700, and / or 800 are contemplated and within the scope of the present disclosure.

[0192] The de-aeration chambers described herein are designed to separate gas (e.g., air) from a liquid (e.g., blood) by facilitating the natural upward movement of gas having a lower density than the liquid toward a top cap of the de-aeration chamber. Thus, the top cap can be said to be or include an upper portion of the de-aeration chamber. An end of the de-aeration chamber opposite the top cap can be referred to as a lower portion or bottom, or as being below the top cap. Thus, in the context of the de-aeration chambers described herein, terms such as above, below, upper, lower, top, and bottom can be used to define particular portions, locations, or directions. Additionally, the dialyzers described herein can be configured to attach to a blood treatment machine (e.g., the treatment module 220) such that a second end cap (a venous end cap) is above a first end cap (an arterial end cap).

[0193] The above devices and methods are examples of the innovative aspects disclosed herein. As described below, but not limited thereto, other embodiments and alternatives are also encompassed within the scope of the present disclosure.

[0194] Although clamps 242 and 244 are described as functioning as on / off valves, in some embodiments, clamps 242 and 244 are used to variably regulate the flow of blood through arterial line 102 and / or venous line 104 (e.g., including a range of partially restrictive clamp settings).

[0195] Although first end cap 120 and second end cap 140 have been described as having ports and pressure chambers of particular arrangements, in some embodiments, the end caps have ports and pressure chambers of other arrangements.

[0196] Although treatment module 220 is described as overhanging from blood treatment machine console 210 by adjustable arm 280, in some embodiments, treatment module 220 is attached to blood treatment machine console 210 by a pivot mechanism, directly attached or integrated therein. In some such cases, the lengths of arterial line 102 and venous line 102 can be greater than one meter.

[0197] Although dialyzer 100 has been described as having integrated pressure detection chambers 122 and 142, in some embodiments, arterial and / or venous pressure detection is performed at a location along arterial line 102 and / or venous line 104, rather than at dialyzer 100. In such cases, pressure detection chambers 122 and / or 142 are removed from dialyzer 100 (although dialyzer 100 can still include an integrated magnetic pump rotor, e.g., rotor 132 or rotor 137).

[0198] Although dialyzer 100 has been described as having an integral magnetic pump rotor (e.g., rotor 132 or rotor 137), in some embodiments, a peristaltic pump is included instead that acts on arterial line 102. In such cases, the rotor is removed from dialyzer 100 (although dialyzer 100 can still include integrated pressure detection chambers 122 and / or 142). Some examples utilize other blood-pumping mechanisms (e.g., diaphragm pumps, screw pumps, piston pumps, peristaltic pumps, etc.).

[0199] Although components of dialyzer 100, such as magnetic pump rotors (e.g., rotor 132 or rotor 137) and pressure detection chambers 122 and 142 have been described as integrated in end caps 120 and 140 of dialyzer 100, in some embodiments, one or more such components can also be integrated into portions of dialyzer 100 other than end caps 120 and 140.

[0200] Although the blood flow path through the dialyzer 100 is illustrated as extending upward from the first end cap 120 at the bottom of the dialyzer 100 to the second end cap 140 at the top of the dialyzer 100, in some embodiments the blood flow path through the dialyzer 100 can extend downward from the second end cap 140 at the top of the dialyzer 100 to the first end cap 120 at the bottom of the dialyzer 100. In such cases, in some embodiments the integrated magnetic pump rotor can be located in the second end cap 140 at the top of the dialyzer 100.

[0201] Although some examples include a treatment module 220 that overhangs from the blood treatment machine console 210 via an arm 280, it should be appreciated that other examples integrate these components as a single unit in a common housing. Also, some examples have treatment modules that are not mechanically supported by a console. For example, some have treatment modules that are mounted to another structure (e.g., a wall or wall mount or floor mount) or placed on a surface such as a table or desk. Such examples can include flexible fluid lines and electrical cables between the module and the console to transport fluids and electrical / signal. Other examples have treatment modules that can receive power separately from the console and / or have wireless communication channels with the console.

[0202] Although the degassing chamber has been described in the context of a venous end cap of a dialyzer, the concept of a degassing chamber can also be implemented in the context of a standalone medical fluid degassing chamber device, or as part of any other suitable fluid handling device, in addition to a dialyzer.

[0203] A number of embodiments of the application have been described. Nevertheless, it will be understood that various modifications can be made without departing from the spirit and scope of the application. Accordingly, other embodiments are within the scope of the following claims.

Claims

1. A dialysis treatment device comprising: a bar-shaped housing defining a longitudinal axis and including first and second end caps at opposite ends of the housing; a plurality of hollow membrane fibers within the interior of the housing between the first end cap and the second end cap, each hollow membrane fiber defining an inner lumen extending longitudinally from the first end cap to the second end cap; and a pump rotor in the first end cap, wherein the pump rotor is a centrifugal impeller such that the blood flow path exits the centrifugal impeller transverse to the longitudinal axis, wherein the dialysis treatment device defines a blood flow path, the blood flow path extending through the first end cap, wherein the blood flow path: (i) enters the first end cap transverse to the longitudinal axis and between the pump rotor and the plurality of hollow membrane fibers, (ii) then transitions to being parallel to the longitudinal axis, (iii) then enters the pump rotor, and (iv) then extends parallel to the longitudinal axis toward the hollow membrane fibers after exiting the pump rotor transverse to the longitudinal axis.

2. The dialysis treatment device according to claim 1, wherein: The blood flow path enters the pump rotor along the center of the pump rotor.

3. The dialysis treatment device according to claim 2, wherein: The pump rotor is centered on the longitudinal axis of the housing.

4. The dialysis treatment device according to any one of claims 1 to 3, wherein: The first end cap redirects blood exiting the centrifugal impeller transverse to the longitudinal axis to flow parallel to the longitudinal axis toward the hollow membranous fibers.

5. The dialysis treatment device according to any one of claims 1 to 4, wherein: The first end cover defines an annular space around the pump rotor.

6. The dialysis treatment apparatus according to any one of claims 1 to 5, further comprising a check valve on the blood flow path.

7. The dialysis treatment device according to any one of claims 1 to 6, wherein: The second end cap includes a port in the blood flow path for administering medication or extracting a fluid sample.

8. The dialysis treatment device according to any one of claims 1 to 7, wherein: The housing also includes a degassing chamber in the blood flow path.

9. The dialysis treatment device according to claim 8, wherein: The degassing chamber is defined in the second end cap.

10. The dialysis treatment device according to any one of claims 1 to 9, wherein: The first end cap includes an inner support plate defining one or more openings through which the blood flow path passes after the pump rotor and before the hollow membrane-like fibers.

11. The dialysis treatment device according to any one of claims 1 to 10, wherein: The dialysis treatment device is a dialyzer.

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