Magnetically levitated blood pump

Abstract

A device including an annular pathway including a channel defined within a housing, an inflow end that facilitates blood flow into the channel, and an outflow end that facilitates blood flow out of the channel. The device includes a rotor disposed within the channel that includes a body, an impeller section connected with the body, and a tail section connected with the body that tapers to a convergence. The device includes one or more tail stator fin(s) that overlay the tail section. The device further includes a removable sleeve disposed within the channel that has one or more sleeve stator fin(s) positioned at the body that increases blood flow within the channel. The tail section extends into both of the outflow end and the channel along a rotational axis. The tail section has a tail length that is longer than an impeller length of the impeller section along the rotational axis.

Description

[0001] Atty. Doc. No. CRNL-154-B-WO / / 10823-02-PC

[0002] MAGNETICALLY LELVITATED BLOOD PUMP

[0003] STATEMENT REGARDING FEDERALLY-SPONSORED RESEARCH OR DEVELOPMENT

[0004] [1] This disclosure was made with government support under Project ID No. PR190230 awarded by the U.S. Army Medical Research Acquisition. The government has certain rights in the disclosure.

[0005] CROSS-REFERENCE TO RELATED APPLICATION(S)

[0006] [2] This application claims priority to and the benefit of U.S. Provisional Patent Application Serial No. 63 / 726,734, filed December 2, 2024, the entire disclosure of which is hereby incorporated by reference.

[0007] TECHNICAL FIELD

[0008] [3] This disclosure relates to a magnetically levitated blood pump that is configured to facilitate blood flow through an organ, such as a heart.

[0009] BACKGROUND

[0010] [4] Mechanical circulatory support devices are used to supplement or replace the pumping function of the human heart in patients suffering from cardiac insufficiency. Traditional blood pumps often rely on mechanical bearings or hydrodynamic supports to maintain the position of a rotating impeller within the pump housing. These mechanical components, while effective in providing stable rotation, introduce frictional losses, wear, and hemocompatibility challenges due to contact between the bearing surfaces and the blood. Over time, such contact can lead to hemolysis, thrombosis, and device failure due to bearing wear or clot formation.

[0011] [5] To overcome these limitations, magnetically levitated rotors (impellers)have been developed to eliminate physical contact between the rotating and stationary components. In these systems, the impeller is suspended and stabilized within the pump housing using magnetic forces, which can be generated by permanent magnets, electromagnets, or any combination thereof. The absence of mechanical contact reduces wear, heat generation, and hemolytic damage, stagnation zones, improving long-term reliability and biocompatibility. [6] Despite these advancements, existing magnetically levitated blood pumps still face challenges in position control, power efficiency, and system complexity. These systems increase device size, cost, and susceptibility to electromagnetic interference. Passive magnetic systems, while simpler, often cannot provide sufficient stability along all axes, leading to undesirable rotor displacement or instability under varying flow conditions.

[0012] [7] Therefore, what is needed is an improved magnetically levitated blood pump that provides enhanced rotor stability, reduced power consumption, improved blood flow, simplified control, and optimized hemodynamic performance, while maintaining compactness and long-term biocompatibility suitable for implantable or extracorporeal use.

[0013] SUMMARY

[0014] [8] Disclosed herein are implementations of a device that includes an annular pathway comprising a channel defined within a housing, an inflow end that facilitates blood flow into the channel, and an outflow end configured to facilitate blood flow out of the channel. The device includes a rotor disposed within the channel. The rotor includes a body; an impeller section connected with the body; and a tail section connected with the body that tapers to a convergence. The device includes one or more tail stator fin(s) that overlay the tail section. The device includes at least one of: the device further comprises a removable sleeve disposed within the channel, the removable sleeve comprising one or more sleeve stator fin(s) positioned at the body, the one or more sleeve stator fin(s) configured to increase blood flow within the channel; the tail section extends into both of the outflow end and the channel along a rotational axis; and / or the tail section has a tail length that is longer than a impeller length of the impeller section along the rotational axis.

[0015] [9] Disclosed are implementations of a device that includes an annular pathway located within a housing and configured to facilitate blood flow and a rotor located within the annular pathway and that rotates within an annular pathway of blood flow. The rotor comprises a shaft and one or more bearing magnet(s), one or more motor magnet(s), and one or more actuator magnet(s) disposed on the shaft. Some or all of the one or more bearing magnet(s), the one or more motor magnets, and the one or more actuator magnet(s) define one or more lateral space(s) therebetween.

[0016] - 2 -

[0017] 4867-4113-8494, v. 1

[0010] Disclosed are implementations of a device that includes an annular pathway defined within a housing and configured to facilitate blood flow, a rotor positioned within the annular pathway that magnetically rotates relative to annular pathway, and two or more noncontact position sensor(s) positioned adjacent to the annular pathway and within the housing. Each of the two or more non-contact position sensor(s) monitor a position of the rotor as the rotor rotates.

[0018]

[0011] Disclosed herein are implementations of a device that includes a housing that includes an annular pathway defined by inner surfaces of the housing that facilitates blood flow. The housing comprises front and rear stator magnet(s) positioned within the housing, two or more voice coil(s) positioned within the housing and separating the front stator magnet and the rear stator magnet, and a motor coil that separates at least two of the two or more voice coil(s). The device further includes a rotor located within that magnetically rotates relative to the annular pathway. The rotor includes two or more bearing magnet(s) connected with a shaft and laterally aligned with the front and rear stator magnet(s), two or more actuator magnet(s) connected with a shaft and laterally aligned with opposing of the two or more voice coil(s) and separate at least two of the two or more bearing magnet(s); and a motor magnet that is connected with a shaft, laterally aligned with the motor coil, and separates at least two of the two or more actuator magnet(s).

[0019]

[0012] Disclosed herein are implementations of a device that includes a stator housing that includes a rotor positioned within an annular pathway of the stator housing. The rotor magnetically rotates relative to the annular pathway on a rotational axis and facilitates the flow of blood. The device further includes a printed circuit board positioned within an electrical housing that is fluidly separated from the stator housing. The printed circuit board includes an axial portion configured to connect with a cable assembly and a base portion extended from the axial portion and electrically interfaced with the stator housing.

[0020]

[0013] Disclosed herein are implementations of a device that includes a housing that includes a channel, an inflow end that includes barbs that connect with a hose and configured to facilitate blood flow into the channel and an outflow end comprising barbs that connect with a hose and facilitate blood flow out of the channel. The housing further includes an inlet hose barb magnetically connected to the housing at the channel and / or the inflow end and an outlet hose barb magnetically connected to the at the channel and / or the outflow end.

[0021]

[0014] Disclosed herein are implementations of a device that includes an annular pathway that includes a channel defined by inner surfaces of a housing, an inflow end that receives blood through an inflow conduit and an outflow end that receives the blood through

[0022] - 3 -

[0023] 4867-4113-8494, v. 1 an outflow conduit. The device further includes at least one stator blade positioned at the channel and / or outflow element and a rotor. The rotor includes an impeller section including at least one blade that forms a flow path divergence, a tail section that forms a flow path convergence at the at least one stator blade, a body that extends between the tail section and the impeller section; and at least one of: an inlet shroud that extends along over a portion of each blade of the impeller section; and / or an outlet shroud that extends along a portion of the at least one stator blade.

[0024] BRIEF DESCRIPTION OF THE DRAWINGS

[0025]

[0015] The disclosure is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not to-scale. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity.

[0026]

[0016] FIG. l is a cross-sectional view of a blood pump.

[0027]

[0017] FIG. 2A is a cross-sectional view of a blood pump.

[0028]

[0018] FIG. 2B is a zoomed in view of the cross-sectional view of the blood pump of FIG. 2 A within box IIB.

[0029]

[0019] FIG. 3 is a comparative illustration of a comparative pressure curve showing the improved performance of an example and a comparative example blood pump (PF4).

[0030]

[0020] FIG. 4A is a cross-sectional view of a blood pump with a removable sleeve.

[0031]

[0021] FIG. 4B is an illustration of the performance of the blood pump with the removable sleeve of FIG. 4 A.

[0032]

[0022] FIG. 4C is a cross-sectional view of the removable sleeve of FIG. 4A.

[0033]

[0023] FIG. 4D is a comparative illustration of performance of the blood pump with the removable sleeve compared to a blood pump without a sleeve.

[0034]

[0024] FIG. 5 A is a cross-sectional view of a blood pump with a shroud.

[0035]

[0025] FIG. 5B is a cross-sectional view of a blood pump with a strut.

[0036]

[0026] FIG. 6 is a cross-sectional view of a rotor.

[0037]

[0027] FIG. 7 is a cross-sectional view of a blood pump including a rotor.

[0038]

[0028] FIGS. 8A-8C are perspective views of a blood pump.

[0039]

[0029] FIG. 9A is a cross-sectional view of a blood pump.

[0040]

[0030] FIG. 9B is a cross-sectional view of the blood pump if FIG. 9A.

[0041]

[0031] FIG. 10A is a cross-sectional view of a blood pump.

[0042] - 4 -

[0043] 4867-4113-8494, v. 1

[0032] FIG. 10B-D are cross-sectional views of a blood pump illustrating different configurations of a magnetically connected pumping hose.

[0044]

[0033] FIG. 11 illustrates configurations of magnet stacks.

[0045]

[0034] FIG. 12 illustrates configurations of non-contact position sensors at locations 1 and 2 and the magnetic fields associated to magnets in the blood pump.

[0046] DETAILED DESCRIPTION

[0047]

[0035] Although claimed subject matter will be described in terms of certain examples, other examples, including examples that do not provide all of the benefits and features set forth herein, are also within the scope of this disclosure. Various structural, logical, and process step changes may be made without departing from the scope of the disclosure.

[0048]

[0036] The claimed subject matter is described in terms of certain examples. But, other examples, including examples that do not provide all of the benefits and features set forth herein, are also within the scope of this disclosure. Various structural, logical, and process step changes may be made without departing from the scope of the disclosure. It is understood that other examples of the present disclosure may be made without departing from the scope of the present disclosure.

[0049]

[0037] Unless stated otherwise, technical and scientific terms used in this specification carry the same meaning as generally understood by those having ordinary skill in the art. Methods and materials that are equivalent or comparable to those described herein may also be employed in practicing or testing the present disclosure.

[0050]

[0038] In the figures, certain features are illustrated in certain sizes and dimensions for illustrative purposes only. The figures are meant to show an example of the teaching described herein and are not meant to be limiting. The scope of the disclosure includes different and varying sizes and dimensions of features illustrated in the figures envisioned by the skilled artisan.

[0051]

[0039] As used herein, unless otherwise stated, “about,” “approximately,” “substantially,” or the like, when used in connection with a measurable variable such as, for example, a parameter, an amount, a temporal duration, or the like, are meant to encompass variations of, for example, a specified value including, for example, those within experimental error (which can be determined by for example, a given data set, an art accepted standard, and / or with a given confidence interval (e.g. 90%, 95%, or more confidence interval from the mean), such as, for example, variations of + / -10% or less, + / -5% or less, + / -1% or less, and + / -0.1% or less of and from the specified value), insofar such variations are appropriate to perform in the

[0052] - 5 -

[0053] 4867-4113-8494, v. 1 context of the disclosure. As used herein, unless otherwise stated, the terms “about,” “approximate,” “at or about,” and “substantially” can mean that the amount or value in question can be the exact value or a value that provides equivalent results or effects as recited in the sample claims or taught herein. That is, it is understood that amounts, sizes, formulations, parameters, and other quantities and characteristics are not and need not be exact, but may be approximate and / or larger or smaller, as desired, reflecting tolerances, conversion factors, rounding off, measurement error, and the like, and other factors known to those of skill in the art such that, for example, equivalent results, effects, or the like are obtained. In some circumstances, the value that provides equivalent results or effects cannot be reasonably determined. In general, an amount, size, formulation, parameter or other quantity or characteristic is “about,” “approximate,” or “at or about” whether or not expressly stated to be such. It is understood that where “about,” “approximate,” or “at or about” is used before a quantitative value, the parameter also includes the specific quantitative value itself, unless specifically stated otherwise.

[0054]

[0040] Ranges of values are disclosed herein. The ranges set out a lower limit value and an upper limit value. Unless otherwise stated, the ranges include the lower limit value, the upper limit value, and all values between the lower limit value and the upper limit value, including, but not limited to, all values to the magnitude of the smallest value (either the lower limit value or the upper limit value) of a range. It is to be understood that such a range format is used for convenience and brevity, and thus, should be interpreted in a flexible manner to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. To illustrate, a numerical range of “about 0.1% to 5%” should be interpreted to include not only the explicitly recited values of about 0.1% to about 5%, but also, unless otherwise stated, include individual values (e.g., about 1%, about 2%, about 3%, and about 4%) and the sub-ranges (e.g., about 0.5% to about 1.1%; about 0.5% to about 2.4%; about 0.5% to about 3.2%, and about 0.5% to about 4.4%, and other possible sub-ranges) within the indicated range. It is also understood that there are a number of values disclosed herein, and that each value is also herein disclosed as “about” that particular value in addition to the value itself. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Ranges can be expressed herein as from “about” one particular value, and / or to “about” another particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about, it will be understood that the

[0055] - 6 -

[0056] 4867-4113-8494, v. 1 particular value forms a further disclosure. For example, if the value “about 10” is disclosed, then “10” is also disclosed.

[0057]

[0041] The present disclosure provides, inter alia, blood pump(s) and improvement(s) thereof. In various examples, the blood pump is a circulatory assist device configured to support a heart, such as, for example, a ventricular assist device (VAD), or the like. In various examples, the blood pump is configured to support circulation of a human heart. In various examples, the blood pump is implantable. In various examples, the blood pump includes a magnetically-levitated rotor driven to rotate by interaction between one or more motor magnets disposed within the rotor and a motor coil disposed within a pump housing around an annular flow path.

[0058]

[0042] The blood pump described herein in one aspect may include a rotor configuration with an optimized tail section that reduces the pressure drop as blood is pumped out of the blood pump, without significant damage to cells flowing through the blood pump. Advantageously, the rotor configuration may reduce energy usage of the blood pump while retaining advantageous blood flow rates. The disclosure provides a more gradual outlet taper (diffuser design) thereby increasing the axial length of the tail section from the annuls to a circular outlet geometry. The hydrodynamics of the system can be improved to achieve increased pressure recovery (improved pressure and flow performance) as compared to other designs, characterized with a steeper taper having a transition that is more abrupt at the tail section. In another example, a compound angle of tail section provides the beneficial flow performance without increasing the distance needed to contain the rotor within the tail stator fins, the outflow end, and / or the channel.

[0059]

[0043] The present disclosure in another aspect provides for a electrical housing that contains and / or connects with a cable assembly such that volume is conserved for the blood pump. By connecting the cable assembly to one or more printed circuit boards, the cables of the cable assembly do not enter into the electrical housing to make direct connections with the internal electrical components, such as sensors, processors, or the like, which also reduces signal noise by minimizing the bending in cables of the cable assembly. Additionally, the cable assembly connects through the printed circuit board, such as through electrical pins, which avoids terminating (welding or soldering) cables directly to the internal electrical components. Accordingly, the present disclosure provides for an advantageous and compact electrical housing configuration within a hermetic enclosure to interact with the magnetically levitated blood pump.

[0060] - 7 -

[0061] 4867-4113-8494, v. 1

[0044] In other words, the present disclosure features a compact multi-pin feedthrough that is parallel to the axis of the pump and inline with the cable feedthrough at the printed circuit board. The printed circuit board comprises an axial portion and base portion that are rigid and perpendicular relative to each other and connected by a flexible portion. The combination of flexible and rigid portions of the printed circuit board is utilized to route and accommodate electrical circuit elements within the hermetic portion of the housing by featuring a section for terminating to the feedthrough pins that is at approximately a right angle with respect to the main board comprising electrical circuit elements and termination points at preferred locations for terminating (soldering) of wires from the Motor, Voice-Coil, and Sensor Coils of the pump assembly. The low profile PCBA which bridges between axial feedthrough pins and radial termination points, facilitates a smaller axillary section of the pump housing, as compared to other designs.

[0062]

[0045] The present invention provides in another aspect an impeller assembly for a magnetically levitated blood pump comprising bearing magnets, permanent magnets, and magnetic subassembly for axial position control. The improved scheme of mounting of magnets within the impeller assembly allows magnets to be made using industry standard tolerances with no post grinding necessary, hence at much lower cost as compared to the prior art.

[0063]

[0046] According to the present disclosure in another aspect, the magnet components of the rotor are first bonded to a shaft. The shaft is maintained in a coaxial arrangement with the impeller section via a precision ID / OD fit between the shaft OD of the shaft and a precision Counterbore ID of the impeller and tail section. A sufficient nominal air gap is provided between the ID of the impeller section for accommodating the magnetic components and the OD of the magnetic components. Thus, the improved configuration accommodates a larger tolerance variability of the magnet components and eliminates the need for post grinding the bonded Hub Assemble. Despite the relaxed tolerances, a substantially co-axial relationship with the magnet components and the axis of the impeller is maintained for ensuring magnetic field symmetry. The hub assembly can further be mass balanced using conventional methods prior to assembly into the impeller section. The substantial loosening of tolerances (corresponding to the magnets) in combination with eliminating the need for post grinding the OD of the magnets results in a significant cost savings for the finished device.

[0064]

[0047] According to the present disclosure in another aspect, axially magnetized magnets are disposed at both ends of the rotor for magnetic interaction with axially magnetized magnets within the stator housing for providing radial stiffness (magnetic radial bearing). The

[0065] - 8 -

[0066] 4867-4113-8494, v. 1 motor and axial actuation means are displaced interposed between the permanent magnets of the radial bearings.

[0067]

[0048] According to the improved disclosure, the two coils of the voice coil actuator are separated and displaced on both sides of the motor so that the motor stator can be disposed in a centralized position with respect to the bearing magnets so as to achieve radial stiffness that is substantially equal with respect to both front and rear radial bearings. As the rotor spins this increase in radial stiffness results in less rotor displacement off-axis. Thus, the blade tip gaps of the impeller can be held to a small distance for improved flow performance with reduced risk of mechanical contact of the impeller blades to the stator housing over the full range of operating speeds. Also, according to the improved design, the magnets used for actuation contribute the stiffness of the bearing magnets

[0068]

[0049] According to the present disclosure in another aspect, one or more non-contact position sensors of various types (Hall effect, magneto-resistive. . ..) are implemented for improved operational performance and stability. The sensor used may be selected from an axial type, and angular type, or a multi axis sensor integrated with a package that is sufficiently small for the miniature blood pump application (preferably having dimensions of 3mm x 3mm x 1.5mm or smaller). According to one aspect a non-contact position sensor that measures both magnitude and field orientation is provided near the inflow end of the pump for measuring rotor position as shown in the following illustration. By providing measurement of magnetic field orientation in addition to magnitude of field strength the sensor provides increased accuracy and signal to noise ratio (Q) as compared to the prior art inductive sensor.

[0069]

[0050] In another aspect, two or more sensors are employed in a spaced apart relationship. As shown in Figure 9A, three non-contact position sensors are displaced circumferentially 120 degrees apart on a flex circuit board of approximately 0.3 mm thickness. These sensors measure field strength and are smaller in form-factor preferably having a package dimension of 1.5 x 1.5 x 0.45mm. The flex circuit with the sensor has a 90- degree fold and is terminated to the Stator PCB along the overlapping section.

[0070]

[0051] The advantage of multiple sensors include increased ability to filter out signal error due to rotor wobble as well as the ability to detect and characterize rotor wobble. With a single sensor, the wobble of the rotor can cause inaccuracy of the sensed axial position. By employing multiple sensors, the true axial position can be known since the combined signal eliminates noise due asymmetrical radial displacement of the rotor. Near high speeds, the rotor may operate with increased instability. Detecting rotor wobble facilitates the ability to

[0071] - 9 -

[0072] 4867-4113-8494, v. 1 optimally adjust speed to optimize performance and minimize touch down risk of mechanical contact of the rotor with the stator.

[0073]

[0052] The blood pump described may include a sleeve with stators that boost the recovery of static pressure after blood passes the impeller section of the rotor and into the channel of the blood pump. Advantageously, the sleeve may be removable so that the boost in blood flow can be an optional feature in each blood pump. For example, a boost in blood flow may be desired in an adult patient. In some examples, the sleeve may be removed so that the blood flow levels are attained in specific situations, such as dealing with sensitive patients.

[0074]

[0053] The blood pump described herein includes a magnetically levitated rotor configured to rotate and move blood within the body without having a significant impact on the cells within the blood. The blood pump may be configured to pump blood within or outside of a body of an organism (e.g., a human). The blood pump may be placed within a body and near an organ, such as a heart. The blood pump may include one or more housings. The housings may include a stator housing and / or an electrical housing. The stator housing may include an annular pathway that contains a rotor, which moves blood into and out of the blood pump. The electrical housing may be configured to connect a cable assembly with the stator housing. The electrical and stator housings may be connected by any means sufficient to operate the blood pump without undesirable leaking of blood or interaction with a body of an organism (e.g., a human). The electrical and stator housings may be sealed such that fluids do not interfere with electrical components and / or connections within the blood pump. Sealing of the electrical and stator housings may be advantageous to avoid ingress of bodily fluids into the electrical or stator housings that would adversely affect the function of the electronics or pumping mechanism.

[0075]

[0054] The stator housing may include an annular pathway that defines a channel. The annular pathway may have any configuration sufficient to allow the rotor to rotate and for blood to flow through the blood pump. Within the annular pathway and / or channel, a rotor may be magnetically levitated and configured to rotate relative to the annular pathway along a rotational axis. The annular pathway may include the channel, the inflow end, and the outflow end. The length of the annular pathway may be measured from the inflow end to the outflow end. The length may be about 25.0 mm to about 35.0 mm, including all 0.1 mm values and ranges therebetween. The width (or diameter) of the annular pathway may be any width sufficient to allow the rotor to rotate and move blood through the annular pathway. The width of the annular pathway may be measured between any two opposing surfaces of the

[0076] - 10 -

[0077] 4867-4113-8494, v. 1 channel, inflow end, and / or outflow end. The width of the annular pathway may vary from the inflow end to the outflow end. For example, the inflow and / or outflow ends may have a width that is less than a width of the channel such that the annular pathway tapers between the channel, inflow end, and / or outflow end. The width of the annular pathway may be 1.0 mm to about 3.0 mm, including all 0.1 mm values and ranges therebetween.

[0078]

[0055] The inflow end may function to facilitate receiving fluids into the blood pump. The inflow end may be configured to connect with a pump hose that is configured to facilitate blood into the blood pump. A pump hose as used herein, unless otherwise stated, means a hose that connects with the inflow and / or outflow ends and moves blood to or from the blood pump. The inflow end may connect with the pump hose and the channel. The inflow end may have a hose opening the connects with the pump hose and a channel opening that is separate and connects with the channel. The hose opening and channel opening may have the same or different widths with a cylindrical and / or tapered section therebetween. The hose opening may have a an internal diameter of 4.0 mm to 10.0 mm or any 0.1 mm values therebetween. The channel opening may be sufficiently large to allow the impeller section of the rotor to rotate relative to the channel. The impeller section may partially extend into the inflow end. The impeller section may be separated from the inflow end.

[0079]

[0056] The channel may function to contain the rotor and allow fluids to flow through the blood pump. The channel may fluidly connect the inflow and outflow ends and allow the rotor to rotate within the channel. The channel may have a width (or diameter) that varies from the inflow end to the outflow end. For example, the channel may have a width at the inflow and / or outflow ends that is less than a width of the channel between the inflow end and the outflow end. Surfaces of the channel may align with or be substantially parallel (e.g., within about 1 and about 10 degrees) with surfaces of the rotor. Some portions or surfaces of the channel may be tapered at an angle that is substantially parallel (e.g., within about 1 and about 10 degrees) with an angle of the body, tapered section, and / or impeller section of the rotor so that blood flows at a desirable rate through the channel as the rotor rotates. The channel may have a length sufficient to contain the rotor and is measured between the inflow and outflow ends. The length of the channel may be about 25 mm to aboutlOO mm, including all 1 mm values and ranges therebetween. The channel may be defined by interior surfaces of the annular pathway and / or stator housing. The channel may be fluidly separated from one or more electrical components of the blood pump (or electrical housing), such as circuits, circuit boards, sensors, processors, wires, electronic components such as resistors, capacitors, integrated circuits, field effect transistors, logic gates, or any combination thereof.

[0080] - 11 -

[0081] 4867-4113-8494, v. 1

[0057] The outflow end may function to facilitate blood out of the blood pump. The outflow end may be configured to connect with a pump hose, similarly to how the inflow end connects with a pump hose. The outflow and inflow ends may in combination function to circulate blood through an organism (e.g., human). The outflow end may have a hose opening the connects with the pump hose and a channel opening that is separate and connects with the channel. The hose opening and channel opening may have the same or different widths (or diameter) with a cylindrical and / or tapered section therebetween. The hose opening may have a width that is smaller than a width of the channel opening. The channel opening may be sufficiently large to allow the tail section of the rotor to rotate relative to the channel. The tail section may partially extend into the outflow end so that fluid flow loss is reduced. The tail section may be separated from the outflow end.

[0082]

[0058] Generally, after blood travel through the blood pump, a change in blood flow rate occurs as blood travels from the channel to the outflow end. Advantageously, the tail section is configured to reduce the amount of drop in blood flow rate. In other words, the blood exiting the blood pump may be maintained at a desirable blood flow rate and with a minimal loss in blood flow after exiting the channel and outflow end. In some examples, the tail section extended into the outflow end may further reduce the loss in blood flow rate by controlling or managing, at least in part, the pressure drop as blood exits the channel and outflow end. In other examples, the tail section may be arranged or configured separate from the outflow end so that blood flow rate is desirably maintained and pressure loss is mitigated. The combination of the tail section and the outflow end may be configured to maintain blood flow rate or pressure (compared to the initial blood flow rate of at the channel or the inflow end before or after blood travels past the impeller section) to about 99 percent to about 50 percent of the initial blood flow rate or initial pressure, including all 5 percent values and ranges therebetween.

[0083]

[0059] The rotor may function to facilitate movement of blood into and out of the blood pump. The rotor may magnetically rotate relative to the channel and / or annular pathway by interaction between one or more motor magnet(s) disposed within the rotor and a motor coil located within the housing. The rotor may be configured to rotate within and / or extend between the channel, the inflow end, and / or the outflow end. The rotor may may have a shape that is cylindrical, conical, or both. For example, the rotor may have a shape that is conical at the tail section and / or the impeller section and a cylindrical shape at the body of the rotor.

[0084]

[0060] The rotor may rotate relative to a rotational axis. The rotational axis may extend through the length of the rotor and / or annular pathway. Internal surfaces of the channel and

[0085] - 12 -

[0086] 4867-4113-8494, v. 1 external surfaces of the rotor at the rotor body may be parallel to the rotational axis. The width or diameter of any component described herein, unless otherwise stated, may be measured by a distance that is perpendicular to the rotational axis. The length of any component described herein, unless otherwise stated, may be measured by a distance that is parallel to the rotational axis. The rotational axis may extend through a rotation center of the rotor. The rotational axis may extend through a center of the annular pathway.

[0087]

[0061] The rotor may have a total length sufficient to drive and maintain a desirable blood flow rate. The rotor may have a total length sufficient to extend between one or more of the channel, the outflow end, and / or the inflow end. The total length of the rotor may be measured from distal portions of the tail and impeller sections. The total length of the rotor may be less than a total length of the annular pathway and / or the combination of the channel, the outflow end, and / or the inflow end. The length of the rotor may be about 10 mm to about 55 mm, including any 1 mm ranges therebetween. The rotor may have a diameter (measured perpendicular to the rotational axis) sufficient to achieve desirable blood flow within the channel. The rotor may have a diameter that is sufficient to achieve a desirable tail angle that reduces pressure drop at the tail section. For example, the diameter of the rotor may be about 5 mm to about 12 mm.

[0088]

[0062] The body (which may also be referred to as the rotor body) may function to house one or more internal components of the rotor, such as one or more magnet(s) (e.g., actuator, motor, bearing magnet(s)), the shaft, one or more spacer(s), or any combination thereof. The body may have external surfaces that are substantially parallel relative to internal surfaces of the channel. The body may include one or more space(s) or gap(s) configured to allow for looser dimensional tolerances of internal components, such as one or more magnet(s). Internal surfaces of the body and internal magnets and / or spacers may define one or more space(s) or gap(s) within the body. The body, the impeller section, and the tail section may in combination fluidly separate the magnet(s), spacer(s), shaft, or any combination thereof from the blood flowing around the rotor within the channel. The body may include a shaft that the rotational axis may extend through. The shaft may connect the body, the impeller section, and the tail section together. The shaft may connect the body, the impeller section, and the tail section by a rotatable connection, such as by one or more threaded connections. The shaft may connect the body, the impeller section, and the tail section by a fixed connection, such as a weld, adhesive, or any combination thereof.

[0089]

[0063] The shaft may function to connect the impeller and the tail section. The connection at the impeller and tail section may be any type of connection desirable, such as

[0090] - 13 -

[0091] 4867-4113-8494, v. 1 by a weld, adhesive, threaded connection, or any combination thereof. The shaft may function to align the rotor with the rotational axis. The shaft may have any length sufficient to allow the rotor and its associated components to rotate relative to the rotational axis and / or channel. The shaft may extend through the body. The shaft may have a length that is less than a length of the rotor. The shaft may have a length that is longer than a length of the body. The shaft may have a length that is smaller or larger than the channel. The shaft may have a length that is greater than the body of the rotor so that the tail and impeller sections are connected. Shaft may have a width (or diameter as measured perpendicular to the rotational axis) may be between about 2.0 mm and about 4.0 mm, including all 0.1 mm values and ranges therebetween.

[0092]

[0064] The impeller section may function to facilitate circulation of blood from a pump house to the channel. The impeller section may include impellers that are free of connection with the inflow section and / or channel. The impeller section may include any number of impeller blades sufficient to attain a desirable blood flow rate. For example, the impeller section may include between one and eight impeller blades, including any one impeller value or range therebetween. The impeller section may have a shape that is conical. The impeller section may have external surfaces that are tapered. The external surfaces of the impeller section may be substantially parallel with surfaces of the channel that are also tapered. The external surfaces of the impeller section may extend to an impeller distal end at a impeller angle, relative to the rotational axis and / or the body. The impeller angle may be about 5 degrees to about 85 degrees, including all 1 degree values and ranges therebetween. The impeller angle may be same or different as a tail angle of the tail section. The impeller section may have a length measured along the rotational axis sufficient to incorporate the a desirable number of impeller blades. . The impeller blades of the impeller section may extend around the rotational axis and / or impeller section at a desirable helical angle (or winding angle) sufficient to drive desirable blood flow. The helical angle may be about 15 to about 270 degrees, including any 1 degree values and ranges therebetween. The impellers may have a length sufficient to extend across portions of the impeller section. For example, the impeller blades may have a length of about 5.0 mm to about 25.0 mm, including all 1.0 mm values and ranges therebetween.

[0093]

[0065] The tail section may function to facilitate blood flow out of the blood pump. The tail section may be configured or arranged to recover static pressure and reduce pressure loss as blood moves from the channel to the outflow end. The tail section may extend partially into, or beyond, the outflow end. The tail section may be positioned solely within the

[0094] - 14 -

[0095] 4867-4113-8494, v. 1 channel. The tail section may be extended between the outflow end and the channel. The tail section may have a length measured along the rotational axis sufficient to reduce the loss of pressure. The tail length may be about 8 mm to about 25 mm, including any values and ranges therebetween (e.g., between about 8 mm and about 16 mm). The tail section may extend to a tail convergence at a tail angle sufficient to gradually enlarge the cross sectional area perpendicular to the axis of rotation and minimize flow separation and maximize recovery of pressure. The tail angle may be measured relative to the rotational axis and / or external surfaces of the body. The tail angle may be different or the same as the impeller angle. The tail angle may align with and / or be parallel to the tail stator fins. The tail angle may be gradual (e.g., less than about a 5 percent change per mm of cross-section) such that the rotor decelerates the flow velocity of the blood, thereby recovering pressure. The tail stator fins may be connected with surfaces of the channel and / or outflow end. The tail angle may be about 10 degrees to about 120 degrees, including all 1 degree values and ranges therebetween (e.g., between about 10 or 20 degrees and about 40 or 50 degrees). Tail or sleeve stator fins may be referred to as tail or sleeve stator blades.

[0096]

[0066] The tail section may have any configuration sufficient to reduce the loss of pressure as blood exits the blood pump. The tail section may have two or more tapered or angled surfaces relative to the rotor body. The two or more tapered or angled surfaces may be separated by an intermediate convergence that separates two surfaces having different angles relative to the rotational axis. For example, the tail section may include an initial section that contacts the rotor body and convergence section that is angled relative to the initial section, connects at an intermediate convergence (or edge), and extends towards the tail convergence. In some examples, intermediate sections separate the initial and convergence sections. The initial, intermediate, and convergence sections may have any angle sufficient to achieve or maintain desirable blood flow rates. The angle of the initial, intermediate, and convergence sections relative to the rotational axis may be about 5 degrees to about 170 degrees, including all 1 degree values and ranges therebetween. The tail section may have any shape sufficient to achieve desirable blood flow. For example, the tail section may include any multicone structure including bicone, tricone, quadcone, pentacone, hexacone, heptacone, octacone, nonacone, and / or dicone having intermediate edges or convergence points between each of the stacked cones. The angles of the tail section or the combination of the initial, intermediate, and convergence sections may be configured to limit the axial travel of the rotor.

[0097] - 15 -

[0098] 4867-4113-8494, v. 1

[0067] The tail section may be composed of any material sufficient to absorb impacts with other components during assembly, transportation, and / or use of the blood pump. The tail section may be composed of a material with sufficiently high shock and abrasion resistance. The tail section may be composed of a ceramic, such as alumina, ruby, zirconia, pyrolytic carb on, another shock resistant and / or scratch resistance inorganic material, or any combination thereof. The tail section may be composed of an elastomer, such as known elastomers in the art. Examples of elastomers without being limiting may include silicone rubber, polyurethanes, or any other blood-compatible elastomer or impact modified polymer. Additionally, the tail section may be composed of a material with high tear resistance to avoid undesirable events with any of the fins or blades positioned within the blood pump.

[0099] The tail stator fin may be configured to align with or overlay the tail section such that blood is directed or facilitated out of the channel, into the outflow end, and out of the blood pump. The tail stator fin may be connected and / or integrated with internal surfaces of the channel and / or outflow end. The tail stator fins may remain fixed as the rotor rotates relative to the internal surfaces of the channel. The tail stator fins may extend along surfaces of the converging or tapering portion of the channel and overlay or interface with surfaces of the tail section of the rotor. The tail stator fins may extend around the rotational axis while connected with the channel at a helical angle sufficient to attenuate rotational flow velocity, thereby convert kinetic energy into pressure. This principle is also known as pressure recovery, or recovery of pressure. The helical angle of the tail stator fins may be about 45 degrees to about 270 degrees, including any 1 degree values and ranges therebetween. The tail stator fins may extend around the rotational axis while connected with the channel at a length sufficient to achieve desirable blood flow. The tail stator fins may extend along and overlay a percentage length of the tail section sufficient to direct the blood flow and maintain desirable blood flow rates. The percentage length may be about 50 percent to about 100 percent of the tail section, including all 1 percent values and ranges therebetween. The tail stator fins may extend within portions of the channel, the outflow end, or both. The tail stator fins may be separated from the impeller blades of the impeller section by a distance sufficient to avoid adverse flow disturbance.

[0100]

[0068] The tail section may have a fullness factor, defined as the scaled area under the camber curve between 0.9 and 1.2 sufficient to maximally recover kinetic energy of the flow as pressure. The tail section may have a trailing edge (such as between 0 and 180 degrees) sufficient to align the streamlines entering the outflow end with the rotational axis. Fullness and trailing edge may be further described in “Multi -Objective CFD Optimization of an

[0101] - 16 -

[0102] 4867-4113-8494, v. 1 Intermediate Diffuser Stage for PediaFlow Pediatric Ventricular Assist Device” Zhussupbekov et al. published in Artificial Organs on 31 July 2025, which is incorporated herein by reference in its entirety.

[0103]

[0069] The blood pump may include a removable sleeve that is configured to improve or boost blood flow rates and / or pressure as blood moves from the inflow section, through the channel including the impeller section, and across the body of the rotor. The removable sleeve may function to increase the blood flow rates and / or pressure of the blood pump, while optionally providing an ability to remove the removable sleeve for applications that require lower flow, such as required for pediatric patients. The removable sleeve may be removed through means sufficient to separate or insert the removable sleeve into the channel or annular pathway of the blood pump. The removable sleeve may have external surfaces that interface, fit, or align with internal surfaces of the channel. The removable sleeve may be configured to interface with parallel surfaces of the channel. The inflow and / or outflow ends may be removed from the annular pathway so that the removable sleeve is removable from the blood pump. The removable sleeve may be located solely within or in multiple portions of the annular pathway. For example, the removable sleeve may extend through one or more of the inflow end, the outflow end, and / or the channel. The removable sleeve may have a length that is sufficient to include a desirable number of sleeve stator fin(s). The removable sleeve may have a length sufficient to avoid undesirable movement within the channel. The removable sleeve may have a length that is about 5 mm to about 25 mm, including any 1 mm values and / or ranges therebetween (such as between about 10 mm and about 20 mm.

[0104]

[0070] The removable sleeve includes one or more sleeve stator fin(s) that function to boost or improve blood flow rate and / or pressure as blood moves from the impeller section and through the channel and towards the outflow end. The removable sleeve may include any number of sleeve stator fin(s) sufficient to boost blood flow rates. The removable sleeve may include a number of sleeve stator fin(s) sufficient to avoid impairing blood flow rates. The removable sleeve may include between one or more and eight or more sleeve stator fin(s), including any number or range of sleeve stator fin(s) therebetween. As blood moves from the impeller section, the circumferential velocity of blood within the channel and the removable sleeve may be reduced from the presence of the sleeve stator fins, thereby converting kinetic energy to pressure. This may be advantageous to reduce the power applied to the rotor, and / or the rotational speed (RPM) to move blood at the impeller section, thereby reducing the propensity to damage cellular elements of the blood (hemolysis.)

[0105] - 17 -

[0106] 4867-4113-8494, v. 1

[0071] The sleeve stator fins may remain fixed as the rotor rotates relative to the internal surfaces of the channel or the removable sleeve. The sleeve stator fins may extend along surfaces of the removable sleeve and overlay or interface with surfaces of the body of the rotor. The sleeve stator fins may extend around the rotational axis while connected with the removable sleeve at a helical angle sufficient to achieve desirable blood flow. The helical angle of the sleeve stator fins may be about 90 degrees to about 270 degrees, including any 5 degree values and ranges therebetween. The sleeve stator fins may extend around the rotational axis while connected with the removable sleeve at a length sufficient to achieve desirable blood flow and / or pressure recovery, and / or reduction in rotational speed of the rotor. The length of the sleeve stator fins may be about 5 mm to about 25 mm, including any 1 mm values and ranges therebetween. The sleeve stator fins may extend along and overlay a percentage length of the body sufficient to direct the blood flow and maintain desirable blood flow rates. The percentage length may be about 5 percent to about 100 percent of the body (e.g., body length), including all 1 percent values and ranges therebetween. The sleeve stator fins may extend within portions of the channel, the outflow end, or both. The sleeve stator fins may be separated from the impellers of the impeller section or the tail stator fin(s) of the tail section by a distance sufficient to achieve desirable blood flow rates. For example, the sleeve stator fin(s) may be separated from the tail stator fin(s) and the impellers may be separated by about 3 mm to about 25 mm, including any 1.0 mm values and ranges therebetween.

[0107]

[0072] The rotor may include one or more magnet(s) (e.g., bearing, motor, actuator magnets) that are configured to magnetically levitate the rotor within the annular pathway and rotate the rotor such the blood is moved through the blood pump and between pump hoses. The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may be configured or arranged on the shaft of the rotor such that the rotor is levitated, stabilized and actuated within the annular pathway without having negative impacts on blood (e.g., clotting, cell damage, etc.). The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may be connected with the shaft through one or more connection features that are configured to align and / or space the one or more magnet(s) (e.g., bearing, motor, actuator magnets) from each other along the shaft. The shaft may include any number of connection features sufficient to align or balance the one or more magnet(s) (e.g., bearing, motor, actuator magnets) to the shaft, such as between one and ten connection features, including any number or range of connection features therebetween.

[0108] - 18 -

[0109] 4867-4113-8494, v. 1

[0073] The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may be balanced for magnetic properties or weight along the shaft so that desirable stabilization, levitation, and / or rotation is achieved within the annular pathway. The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a shape sufficient to allow the rotor to rotate relative to the channel and / or rotational axis. The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a shape sufficient to be contained within the body of the rotor. The body of the rotor may be configured to separate the one or more magnet(s) (e.g., bearing, motor, actuator magnets) from the annular pathway so that the one or more magnet(s) (e.g., bearing, motor, actuator magnets) do not undesirably interact with the blood within the annular pathway. For example, the one or more magnet(s) (e.g., bearing, motor, actuator magnets) have a shape of a ring, cylinder, cone, or any combination thereof.

[0110]

[0074] Each of the one or more magnet(s) (e.g., bearing, motor, actuator magnets) of the rotor may have a length along the rotational axis sufficient to achieve stabilization, levitation, and / or rotation desirable to have the rotor rotate within the annular pathway. The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a length (measured parallel to the rotational axis) that aligns with, corresponds to, or is the same as an opposing magnet of the stator housing. Magnets of the stator housing are positioned within the stator housing and / or separated from the annular pathway and assist with levitation, rotation, and / or stabilization of the rotor so the rotor rotates within the blood pump without contacting components of the annular pathway. For example, the one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a length of 2.0 mm to about 6.0 mm, including all 0.1 mm values and ranges therebetween. The one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a diameter (measured perpendicular relative to the rotational axis) that is sufficient to fit the one or more magnet(s) (e.g., bearing, motor, actuator magnets) within the body of the rotor. For example, the one or more magnet(s) (e.g., bearing, motor, actuator magnets) may have a diameter of 5.0 mm to about 10.0 mm, including all 0.1 mm values and ranges therebetween. Configurations of magnets may be described in Paden BE, NJ Groom, JF Antaki. Design formulae for permanent magnet bearings. ASME J Mechanical Design, 125:734-738, 2003, the entire disclosure of which is hereby incorporated by reference herein.

[0111]

[0075] The one or more bearing magnet(s) may function to provide axial and / or radial magnetic forces (i.e., parallel and / or perpendicular to the rotational axis) that are configured to at least in part levitate and / or stabilize the rotor within the annular pathway. The one or more bearing magnet(s) may be referred to as front and rear bearing magnets (e.g., front and

[0112] - 19 -

[0113] 4867-4113-8494, v. 1 rear pairs of bearing magnets). The one or more bearing magnet(s) may in combination with the one or more motor magnet(s) may operate to rotate the rotor. Generally, the rotor may include at least two of the bearing magnet(s) or two pairs of the bearing magnet(s) that are positioned at distal ends of the shaft proximate or adjacent to the impeller and / or tail sections. In some examples, some of the one or more bearing magnet(s) may be positioned between other magnets instead of being positioned at a distal end of the shaft. The rotor may include any number of bearing magnets sufficient to balance the rotor. For example, the rotor may include one to sixteen of the bearing magnets, including any number or range of bearing magnets therebetween.

[0114]

[0076] The one or more actuator magnets may function to provide radial and / or axial magnetic forces (i.e., parallel and / or perpendicular to the rotational axis) that are configured to at least in part levitate and / or stabilize the rotor within the annular pathway. The one or more actuator magnet(s) may in combination with the one or more motor magnet(s) may operate to rotate the rotor. Generally, the rotor may include at least two of the actuator magnet(s) that are positioned between other magnets (e.g., between motor or bearing magnets) and provide radial forces in opposing directions. For example, two or more actuator magnet(s) may provide magnetic forces in two opposing directions along the rotational axis. Two or more pairs of actuator magnet(s) may be placed between or adjacent to motor and / or bearing magnets. Two or more pairs of actuator magnet(s) may be separated from each other by other magnets, such as one or more motor magnet(s). The actuator magnets may be separated from the impeller and / or tail sections by bearing magnets. The actuator magnets may be separated from each other by one or more motor magnet(s). The rotor may include any number of actuator magnets sufficient to balance the rotor. For example, the rotor may include one to eight of the actuator magnets, including any number or range of actuator magnets therebetween.

[0115]

[0077] The one or more motor magnets may function to provide rotational magnetic forces (i.e., relative to the rotational axis) that are configured to rotate the rotor within the annular pathway. The one or more motor magnet(s) may in combination with the one or more actuator and / or bearing magnet(s) may operate to rotate the rotor. Generally, the rotor may include one of the motor magnet(s) that are positioned between other magnets (e.g., between actuator or bearing magnets) and provide rotational forces in combination with other magnets to rotate the rotor within the annular pathway. The motor magnet may be essentially centered along the shaft and / or rotor such that the rotation of the rotor does not wobble along the rotational axis. The rotor may include any number of motor magnets sufficient to allow the

[0116] - 20 -

[0117] 4867-4113-8494, v. 1 rotor to rotate. For example, the rotor may include one to eight of the motor magnets, including any number or range of motor magnets therebetween.

[0118]

[0078] Any of the one or more magnet(s) (e.g., bearing, motor, actuator magnets) may include spaces therebetween such that the one or more magnet(s) (e.g., bearing, motor, actuator magnets) can have slightly different lengths and still be balanced and / or fit on the shaft. In other words, lateral spaces may provide for improved size tolerance of the one or more rotors and / or shaft. The lateral spaces may in combination with gaps of the rotor improve size tolerance of the rotor. The lateral spaces and / or gaps therebetween may be defined by one or more magnet(s) (e.g., bearing, motor, actuator magnets) and / or internal surfaces of the impeller section, the tail section, and / or body. The lateral spaces and / or gaps may have any length and / or width sufficient to improve size tolerance of the shaft and / or rotor. The length and / or width of the gaps and / or lateral spaces may be about 0.5 mm to about 2.0 mm, including any 0.1 mm values or ranges therebetween.

[0119]

[0079] The shaft may additionally include one or more spacer(s) positioned between the one or more magnet(s) (e.g., bearing, motor, actuator magnets). The one or more spacer(s) may function to desirably space the one or more magnet(s) (e.g., bearing, motor, actuator magnets) along the shaft. The one or more spacer(s) may connect with the shaft through one or more connection features configured to desirably space the one or more magnet(s) (e.g., bearing, motor, actuator magnets) along the shaft. The one or more spacer(s) may additionally be placed between the one or more magnet(s) (e.g., bearing, motor, actuator magnets) and either or both of impeller and / or tail sections. The one or more spacer(s) may have a same or different width (measured perpendicular from the rotational axis) than the one or more magnet(s) (e.g., bearing, motor, actuator magnets). The width of the one or more spacer(s) may be less than the one or more magnet(s) (e.g., bearing, motor, actuator magnets) so that additional open lateral or vertical space is provided inside the body of the rotor. The one or more spacer(s) may have any shape sufficient to separate the one or more magnet(s) (e.g., bearing, motor, actuator magnets). For example, the one or more spacer(s) may have a shape of a cylinder, ring, cone, , or any combination thereof. The one or more spacer(s) may have a length sufficient to desirably space or balance the one or more magnet(s) (e.g., bearing, motor, actuator magnets) from each other along the shaft. For example, the one or more spacer(s) may have a length of about 0.5mm to about 2.0 mm, including all 0.1 mm values or range therebetween. In some examples, all of the one or more magnet(s) (e.g., bearing, motor, actuator magnets) may be directly contacted or connected with the shaft. In other words, the one or more magnet(s) (e.g., bearing, motor, actuator magnets) may contact

[0120] - 21 -

[0121] 4867-4113-8494, v. 1 or connect the shaft without any intervening components, supports, or spacers therebetween so that the one or more magnet(s) (e.g., bearing, motor, actuator magnets) can be fixedly attached to the shaft and save space in the body of the rotor.

[0122]

[0080] The stator housing may include one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) that are permanently positioned within the stator housing and configured to magnetically levitate the rotor within the annular pathway and rotate such the blood is circulated through the blood pump and between pump hoses. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may be configured or arranged within the stator housing and fluidly separated from the blood in the annular pathway. In some examples, the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may form or define portions of the annular pathway and may come into contact with blood as the rotor rotates. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may be connected with the printed circuit board through one or more electrical interfaces, wires, cables, and / or a board extension.

[0123]

[0081] The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may be balanced or centered relative to the rotor for desirable magnetic properties within the annular pathway so that desirable stabilization, levitation, and / or rotation is achieved within the annular pathway. In other words, the arrangement of the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may function to balance pitch, yaw, and / or roll shifts in the rotor during rotations by efficiently spacing the one or more magnet(s) (e.g., bearing, actuator, and / or motor magnets) of the rotor and the magnets and / or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) of the stator housing. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a shape sufficient to correspond with opposing magnets and allow the rotor to rotate relative to the channel and / or rotational axis. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a shape sufficient to be contained within the stator housing and / or adjacent to the annular pathway (e.g., channel, inflow end, and / or outflow end). The channel or interior surfaces of the annular pathway may be configured to separate the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) from the annular pathway so that the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) do not undesirably interact with the blood within the annular pathway. For example, the one or more magnet(s) (e.g., bearing, motor, actuator magnets)

[0124] - 22 -

[0125] 4867-4113-8494, v. 1 have a shape of a ring, cylinder, cone, annulus, sector of annulus, sector of a circle, or any combination thereof.

[0126]

[0082] The stator housing may include front and rear permanent magnets (may also be referred to as stator magnets) that are configured to magnetically interface with the one or more bearing magnet(s) such that the rotor is levitated, stabilized, and / or rotated within the annular pathway. The front and rear permanent magnets may function to provide axial and / or radial magnetic forces (i.e., perpendicular or parallel to the rotational axis) that are configured to at least in part levitate and / or stabilize the rotor within the annular pathway. The front and rear permanent magnets may be referred to as one or more permanent magnets (e.g., front and rear pairs of bearing magnets). The front and rear permanent magnets may in combination with the one or more motor coil(s) or other magnet(s) or coil(s) may operate to rotate the rotor within the annular pathway. Generally, the rotor may include two or more of the front and rear permanent magnet(s) or two pairs of the front and rear permanent magnets that are positioned at distal ends of the stator housing proximate or adjacent to the impeller and / or tail sections and / or inflow and / or outflow ends, respectively. In some examples, some of the one or more permanent magnet(s) may be positioned between other magnets instead of being positioned at distal ends of the stator housing. The stator housing may include any number of permanent magnets sufficient to balance the rotor. For example, the stator housing may include one to sixteen of the permanent magnets, including any number or range of permanent magnets therebetween.

[0127]

[0083] The stator housing may include one or more voice coil(s) that are configured to magnetically interface with the one or more actuator magnet(s) such that the rotor is levitated, stabilized, and / or rotated within the annular pathway. The one or more voice coil(s) may function to provide radial and / or axial magnetic forces (i.e., parallel to the rotational axis) that are configured to at least in part levitate and / or stabilize the rotor within the annular pathway. The one or more voice coil(s) may in combination with the one or more motor coil(s) may operate to rotate the rotor. Generally, the stator housing may include at least two of the voice coil(s) that are positioned between other magnets (e.g., between motor or bearing magnets) and provide radial forces in opposing directions. For example, two or more voice coil(s) (s) may provide or facilitate magnetic forces in two opposing or different directions along the rotational axis. Two or more pairs of actuator magnet(s) may be separated from each other by other magnets or coils, such as one or more motor coils(s). The one or more voice coil(s) may be separated from the inflow and outflow ends by permanent magnets. The voice coil(s) may be separated from each other by one or more motor coil(s). The stator

[0128] - 23 -

[0129] 4867-4113-8494, v. 1 housing may include any number of voice coils sufficient to balance the rotor within the annular pathway. For example, the stator housing may include one to eight of the voice coils, including any number or range of voice coils therebetween.

[0130]

[0084] The stator housing may include one or more motor coil(s) that are configured to magnetically interface with the one or more motor magnet(s) such that the rotor is levitated, stabilized, and / or rotated within the annular pathway. The one or more motor coil(s) may function to provide rotational magnetic forces (i.e., relative to the rotational axis) that are configured to rotate the rotor within the annular pathway. The one or more motor coil(s) may in combination with the one or more voice coil(s) may operate to rotate the rotor. Generally, the stator housing may include one of the motor coil(s) that are positioned between other magnets (e.g., between voice coils and permanent magnets) and provide rotational forces in combination with other magnets (e.g., magnets of the rotor) to rotate the rotor within the annular pathway. The motor coils may be essentially centered along the shaft and / or rotor such that the rotation of the rotor does not wobble along the rotational axis. The motor coil mail be aligned with the motor magnet of the rotor such that the rotor rotates without undesirable wobbling or tilt. The stator housing may include any number of motor coils sufficient to allow the rotor to rotate. For example, the stator housing may include one to eight of the motor magnets, including any number or range of motor magnets therebetween.

[0131]

[0085] Each of the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) of the stator housing (i.e., that interface with the bearing, actuator, and motor magnets of the rotor) may have a length along the rotational axis sufficient to achieve stabilization, levitation, and / or rotation desirable to have the rotor rotate within the annular pathway. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a length (measured parallel to the rotational axis) that aligns with, corresponds to, or is the same as an opposing magnet of the rotor. Magnets of the rotor are positioned within the body of the rotor and / or separated from the annular pathway and assist with levitation, rotation, and / or stabilization of the rotor so the rotor rotates within the blood pump without contacting components of the annular pathway. For example, the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a length of 2mm to about 10mm, including all values and ranges therebetween. The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a width (measured perpendicular relative to the rotational axis) that is sufficient to fit the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) within the housing and / or body of the rotor. For

[0132] - 24 -

[0133] 4867-4113-8494, v. 1 example, the one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) may have a width of about 10 mm to about 20 mm, including all 1 mm values and ranges therebetween (e.g., between about 14 mm and about 18 mm). The one or more magnet(s) or coil(s) (e.g., permanent magnets, voice coils, motor coils, or the like) or the stator housing may have a length or width that corresponds to the opposing one or more magnets (e.g., bearing, actuator, and / or motor magnets) of the rotor.

[0134]

[0086] The stator housing may include one or more non-contact position sensor(s) positioned along, adjacent, proximate to, or around the annular pathway configured to detect a position of the rotor within the annular pathway (including within the inflow end, the outflow end, and / or the channel). The one or more non-contact position sensor(s) may be configured to detect a change in magnetic field strength and / or direction (e.g., vector) of the magnetic field of at least one of the magnets or coils in the blood pump. The one or more non-contact position sensor(s) may function to detect any anomalies during rotation of the rotor within the rotor or around the rotor at the annular pathway. The one or more non-contact position sensor(s) may function to detect whether the rotor has any tilt or wobble (e.g., roll, pitch, and / or yaw) along any of the axes (e.g., rotational axis X, y-axis Y, and / or z-axis Z). The one or more non-contact position sensor(s) may function to detect whether any one of the magnets or coils is introducing undesirable tilt or wobble (e.g., roll, pitch, and / or yaw) along any of the axes (e.g., rotational axis X, y-axis Y, and / or z-axis Z). The one or more noncontact position sensor(s) may be positioned within the stator housing and fluidly separated from the annular pathway. The one or more non-contact position sensor(s) may be supported by any means sufficient to detect rotational position of the rotor. The one or more non-contact position sensor(s) may be supported by one or more circuit(s) that are configured to electrically integrate or interface with one or more printed circuit board(s) of the electrical housing. The one or more non-contact position sensor(s) may extend parallel or perpendicular to the rotor relative to the rotational axis. The one or more non-contact position sensor(s) may be positioned at any location within along the annular pathway, such as adjacent to, proximate to, or integrated with one or more of the inflow end, the outflow end, the channel, or any combination thereof.

[0135]

[0087] The non-contact position sensors may be comprised of magneto resistive sensors, hall-effect sensors, eddy-current sensors, or other sensors known the art to measure the strength of magnetic field. The non-contact position sensor may include any sensor configuration, such as an axial sensor, an angular sensor, or a multi-axis sensor. The noncontact position sensor may include any composition sufficient to detect the physical

[0136] - 25 -

[0137] 4867-4113-8494, v. 1 position, or other desirable data regarding the blood pump. For example, the non-contact position sensor may include a thin film of magneto-resistive material including an alloy, such as, for example, InSb, InAs, or GaAs. The non-contact position sensor may have a form of a encapsulated package sensor. In various examples, the non-contact position sensors have dimensions of about 3 mm x about 3 mm x about 1.5 mm or less. In various examples, the non-contact position sensor has dimensions of about 3 mm x about 3 mm x about 1.45 mm.

[0138]

[0088] The blood pump may include any number of the one or more non-contact position sensor(s) sufficient to detect the physical position, or other desirable data about the rotor or other components of the blood pump. For example, the blood pump may include between one and fifteen of the non-contact position sensor(s). The one or more non-contact position sensor(s) may be spaced a distance from the rotational axis and / or the rotor such that desirable information is detectable relative to the rotor or associated magnets and / or coils. Relative to a y and z-axis that intersect the rotational axis, the one or more non-contact position sensors may be spaced circumferentially from each other at an angle that evenly spaces the one or more non-contact position sensor(s) from each other. For example, the one or more non-contact position sensor(s) may be spaced circumferentially by about 5 to about 180 degrees, including all 1 degree values or ranges therebetween.

[0139]

[0089] The stator housing may include a sensor circuit configured to support the one or more non-contact position sensor(s). The sensor circuit may function to support and / or electrically interface with the one or more non-contact position sensor(s). The sensor circuit may electrically interface with a printed circuit board that is configured to relay information through a cable assembly about the positional data of the rotor or other data related to the annular pathway. The sensor circuit may extend around the annular pathway within the stator housing. The sensor circuit may extend around all of or portions of the annular pathway. The sensor circuit may extend within the stator housing at an angle that is perpendicular or parallel relative to the rotational axis.

[0140]

[0090] The stator housing may include a board extension that connects the sensor circuit, the non-contact position sensors and the printed circuit board. The board extension may function as a physical support and an electrical interface between the sensor circuit and the printed circuit board. In some examples, the board extension may extend between the sensor circuit and the printed circuit board at an angle relative to the rotational axis, such as between 0 and 180 degrees, including all 1 degree values and ranges therebetween. The board extension may connect two separate circuits (e.g., a sensor circuit and another circuit) to the

[0141] - 26 -

[0142] 4867-4113-8494, v. 1 printed circuit board within interfering with any of the internal magnets or coils within the stator housing.

[0143]

[0091] The electrical housing may function to contain electrical components of the blood pump in an efficient manner. The electrical housing may be configured to seal the electrical components from fluids or blood that surround or is adjacent to the blood pump. The electrical housing may be configured to connect with a cable assembly such that the blood pump can receive power and transmit electrical signals (e.g., related to controlling operation, detecting data, configuring operational parameters, such as temperature and acceleration, or any combination thereof). The electrical housing may be configured to connect a cable assembly and a printed circuit board that is configured to interface with components of the rotor and / or annular pathway.

[0144]

[0092] The electrical housing may be connected with a cable assembly that is configured to connect the blood pump with external hardware that controls, powers, and / or monitors operation of the blood pump. The cable assembly includes one or more cable(s) or wire(s) that are configured to separately or in combination control, power, and / or monitor the blood pump. The cable assembly may connect with the printed circuit board through one or more electrical pin(s) associated with each of the one or more cable(s) or wire(s). Any number of electrical pin(s) may be used to match or correspond with the number of cable(s) or wire(s), such as between one and forty cable pins, including all numbers and ranges of pins therebetween. The electrical pin(s) may be fixed within a feedthrough assembly and extend through the feedthrough assembly in a direction that is parallel relative to rotational axis. The electrical pin(s) electrically may connect the printed circuit board and the cable assembly such that bending of the cable assembly is minimized and signal noise from the cables or wires is subsequently minimized during operation of the blood pump. Additionally, by using the electrical pin(s) to connect with the printed circuit board, safe can be spaced within the electrical housing while simultaneously reducing noise due to avoiding bends and direct connections with electrical components of the printed circuit board.

[0145]

[0093] The electrical housing may include a feedthrough assembly that is configured connect with the cable assembly. The feedthrough assembly may be connected with or integrated with one or both of the electrical and stator housings. The feedthrough assembly may include apertures configured to connect with and / or secure the electrical pins within electrical housing so that the cable assembly can connect with the printed circuit board. The feedthrough assembly may include a feedthrough chamber configured to allow the cable assemble to connect with the electrical pins. The feedthrough assembly may include a cable

[0146] - 27 -

[0147] 4867-4113-8494, v. 1 assembly opening configured to connect with the cable assembly and allow the cables or wires of the cable assembly to connect with the electrical pins. The feedthrough assembly may support walls of the electrical housing.

[0148]

[0094] The electrical housing includes a printed circuit board configured to electrically interface with the components of the stator and / or electrical housing. The printed circuit board may function to support electrical components and connect the cable assembly with the electrical components. The printed circuit board may function to connect components (e.g., magnets, coils, sensors) associated with the rotor and the cable assembly. The printed circuit board may be fluidly separated from fluids or blood in an organism by walls of the electrical housing. The printed circuit board may be connected with the stator housing through one or more fastener(s) (e.g., screws, adhesive, welds, nails, etc.). The one or more fastener(s) may extend between the printed circuit board and a surface of the stator housing such that the printed circuit board does not shift during operation of the blood pump.

[0149]

[0095] The printed circuit board includes an axial portion, a base portion, and a flexible portion. The axial portion, the base portion, and the flexible portion are configured in combination to connect the cable assembly to one or more electrical component(s) on the base portion of the printed circuit board and subsequently control, operate, and / or detect information with the one or more electrical component(s). The base portion may include any electrical components utilized to electrically interface with the cable assembly and / or the rotor or associated components (e.g., magnets, coils, sensors, or the like). The axial portion may be configured to connect with the electrical pins such that the cable assembly can electrically interface with the printed circuit board (e.g., the base portion). The axial portion and base portion may be substantially perpendicular relative to each other. The axial portion and the base portion may be connected by a flexible portion that is configured to electrically interface the axial and base portions. The flexible portion may have more flexibility than the axial and base portions such that the axial and base portions are rotatable relative to each other up to about a 90 degree angle without damaging the flexible portion. Conversely, the axial and base portions may have rigidity sufficiently high such that the axial and base portions do not bend or deform during operation of the blood pump or while connected with the cable assembly.

[0150]

[0096] The printed circuit board advantageously improves space saving and minimizes signal noise in the cable assembly by connecting the cable assembly at the axial portion. For example, the axial portion provides an advantage in that cables or wires of the cable assembly do not bend or distort and extend through the feedthrough assembly to connect with the

[0151] - 28 -

[0152] 4867-4113-8494, v. 1 electrical components of base portion. Because the wires or cables of the cable assembly do not extend through the feedthrough assembly, a significantly smaller electrical housing can be utilized while retaining desirable electrical components in the blood pump.

[0153]

[0097] The blood pump may include parings of barb and stator magnet rings (may also be referred to as inlet and / or outlet hose barbs) at either or both of the inflow and / or outflow ends so that a pump hose may be removably attached to the blood pump with relative ease. The barb and stator magnet rings in combination function to connect, seal, and / or connect the pump hose to the inflow and / or outflow ends. Barbs positioned on the inflow and / or outflow ends may additionally assist to secure the pump hoses against the inflow and / or outflow ends through friction and / or rotatable fits or any other means to releasably secure a pump hose against the inflow and / or outflow ends. Any number of barb and / or stator magnet rings may be positioned at either or both of the inflow and / or outflow ends. For example, the between one and four pairs of barb and stator magnet rings may be include at each of the inflow and / or outflow ends, including all values and ranges therebetween. The barb and stator magnet rings may be integrated into either or both of the stator housing or the pump hose so long as the pump hose is easily attachable and detachable while retaining advantageous blood flow properties during operation of the blood pump. The barb and stator magnet rings may connect the pump hose against the inflow and / or outflow ends such that essentially no or no space is present between the pump hose and the inflow and / or outflow ends. The barb and stator magnet rings may connect the pump hose against the inflow end and / or outflow end in a fluidly sealed manner such that blood does not become enter or become trapped between the pump hose and the inflow end and / or outflow end. In some examples, an edge or flange is disposed between the pump hose and the inflow and / or outflow ends so that blood does not move into contact with the spaces therebetween.

[0154]

[0098] The annular pathway and / or channel may include one or more flow straightener stator fin(s) that remain fixed within the channel and downstream of the impeller section as the rotor rotates. The one or more flow straightener stator fin(s) may function to straighten blood or mitigate turbulence as blood is moved towards impeller blades of the rotor. The one or more flow straightener stator fin(s) may be positioned upstream, downstream, or between impeller blades of the rotor. The one or more flow straightener stator fin(s) may be downstream, upstream, or between the one or more tail shroud(s) and / or impeller shroud(s). The one or more flow straightener stator fin(s) may extend around the rotational axis and / or channel at a desirable helical angle (or winding angle) sufficient to drive or facilitate desirable blood flow. The helical angle may be about 0 degrees to about 90 degrees, including

[0155] - 29 -

[0156] 4867-4113-8494, v. 1 any values and ranges therebetween. The one or more flow straightener stator fin(s) may have a length sufficient to extend across portions of the channel. For example, the one or more flow straightener stator fin(s) may have a length of about 6 mm to about 18 mm, including all 1 mm values and ranges therebetween. The annular pathway and / or channel may include any number of flow stator fin(s), such as between one and eight flow stator fins, including any number of flow stator fins therebetween.

[0157]

[0099] The annular pathway may include one or more channel stator fin(s) that remain fixed within the channel as the rotor rotates. The one or more channel stator fin(s) may function to straighten blood or mitigate turbulence as blood is moved towards the tail section of the rotor. The one or more channel stator fin(s) may be positioned upstream, downstream, or between impellers of the rotor. The one or more channel stator fin(s) may be downstream, upstream, or between the one or more tail shroud(s) and / or impeller shroud(s). The one or more channel stator fin(s) may extend around the rotational axis and / or channel at a desirable helical angle (or winding angle) sufficient to drive or facilitate desirable blood flow. The helical angle may be about 90 degrees to about 270 degrees, including any 5 degree values and ranges therebetween. The one or more channel stator fin(s) may have a length sufficient to extend across portions of the channel. For example, the one or more channel stator fin(s) may have a length of about 6 mm to about 18 mm, including all 1 mm values and ranges therebetween. The annular pathway and / or channel may include any number of channel stator fin(s), such as between one and eight channel stator fins, including any number of channel stator fins therebetween.

[0158]

[0100] The tail stator fins may include one or more tail shroud(s) that are configured to overlay the tail section of the rotor. In some examples, the one or more tail shroud(s) may be directly affixed to portions of the channel and / or the tail stator fins. The one or more tail shroud(s) may be configured to mitigate impacts of the rotor (e.g., tail section) or tail stator fins with portions of the channel or rotor. The one or more tail shroud(s) may be extend at an angle (e.g., substantially perpendicular) from the one or more tail stator fin(s). The one or more tail shroud(s) may have sufficient thickness to mitigate impacts of the tail section. Any number of the one or more tail shroud(s) may be included, such as between one and eight tail shrouds, including any number of tail shrouds therebetween.

[0159]

[0101] The rotor may include one or more impeller shroud(s) that are configured to overlay or be integrated with one or more impeller(s) of the impeller section. In some examples, the impeller shroud(s) are directly affixed to or integrated with the impeller section. In some examples, the impeller shroud(s) may be affixed to or integrated with the

[0160] - 30 -

[0161] 4867-4113-8494, v. 1 channel. The one or more impeller shroud(s) may be configured to mitigate impacts of the rotor (e.g., impeller blads or impeller section) with portions of the channel. The one or more impeller shroud(s) may be extend at an angle (e.g., substantially perpendicular) from the one or more impeller blade(s). The one or more impeller shroud(s) may have sufficient thickness to mitigate impacts of the impeller section and / or channel. Any number of the one or more impeller shroud(s) may be included, such as between one and eight impeller shrouds, including any number of impeller shrouds therebetween.

[0162]

[0102] The rotor may include one or more body impeller blade(s) that are positioned within the channel and downstream of the impeller section at the body. The one or more body impeller blade(s) may function to drive or facilitate blood flow into the tail section of the rotor. The one or more body impeller blade(s) may be positioned downstream of other impeller blades of the rotor. The one or body impeller blade(s) may be downstream, upstream, or between the one or more tail shroud(s) and / or impeller shroud(s). The one or more body impeller blade (s) may extend around the rotational axis and / or rotor at a desirable helical angle (or winding angle) sufficient to drive or facilitate desirable blood flow. The helical angle may be about 45 degrees to about 270 degrees, including any 5 degree values and ranges therebetween. The one or more body impeller blade(s) may have a length sufficient to extend across portions of the channel. For example, the one or more body impeller blade(s) may have a length of about 5 mm to about 20 mm, including all 1 mm values and ranges therebetween.

[0163]

[0103] The one or more magnets described herein may further include a shimming magnet disposed within the stack of magnets. A shimming magnet may function to provide an eccentric magnetic field between two or more magnets (e.g., two or more bearing magnets) that rotate with respect to one another such that the shimming magnet results in a tuned and / or effectively balanced magnetic field. The shimming magnet may be positioned between any two or more rotating magnet(s), (e.g., bearing magnets). The shimming magnets may be positioned between two magnets that have different magnetic forces. The shimming magnets may be positioned between lateral or internal surfaces of the two or more rotating magnet(s). For example, the shimming magnets may be included with a stack of magnets. The shimming magnets may be positioned between a stack of bearing magnets, such as front and / or rear bearing magnets.

[0164]

[0104] FIG. 1 is a cross-sectional view of a blood pump 100. The blood pump 100 may be referred to as a device, system, and / or apparatus. The blood pump 100 includes an electrical housing 102 and a stator housing 104 that are connected and contain the

[0165] - 31 -

[0166] 4867-4113-8494, v. 1 components of the blood pump 100. A cable assembly 106 provides power and communication to a printed circuit board 108 that electrically controls operation of a rotor 110. As the rotor 110 rotates, blood or other fluids are moved through a channel 112 from an inlet end 114 to an outlet end 116 at a desirable blood flow. As the rotor 110 rotates relative to the rotational axis X, an impeller section 118 of the rotor moves blood with an impeller blade 120 such that blood moves towards and along a body 122 of the rotor 110. The blood continues to move towards the tail section 124 that is angled relative to the body 122 such that the flow of blood is maintained at a desirable rate. Tail stator fins 126 that extend along the tail section 124 and connect with inner surfaces 128 of the stator housing 104 help facilitate blood flow out of the blood pump 100 by remaining fixed as the rotor 110 rotates. The inner surface 128 extends between the inflow and outflow ends 114, 116 and define the channel 112. The inner surfaces 128 are tapered at or proximate to the inflow and outflow ends 114, 116 to facilitate blood flow around the rotor 110.

[0167]

[0105] The tail section 124 has tapered surfaces 130 relative to the body 122 that extend to a convergence 132. The tail section 124 further extends between the channel 112 and the outflow end 116 so that the blood flow rate is not undesirably lost as blood flows out of the blood pump 100. The tail section 124 extends into the outflow end 116 to the convergence 132 at a convergence angle A sufficient to maintain or reduce the loss of the blood flow rate out of the blood pump 100. The convergence angle A is measured between the tapered surfaces 130 and the rotational axis X.

[0168]

[0106] The channel 112, the inflow end 114, and the outflow end 116 may collectively be referred to as an annular pathway configured to facilitate the flow of blood into and out of the blood pump 100. The channel has a width DI (measured perpendicular relative to the rotational axis X) that is greater than a width D2 of the outflow end 116 so that the rotor 110 can rotate within the channel 112 and circulate blood out of the outflow end 116. The width D2 is sufficiently large to contain the tail section 124 and allow blood to flow out of the blood pump 100. The channel 112 tapers in width towards the inflow and outflow ends 114,

[0169] 116 so that the annular pathway can house the rotor 110 and allow the rotor 110 to rotate relative to the rotational axis X without undesirable interacting with the interior surfaces 128 of the channel 112.

[0170]

[0107] The outflow end 116 may be distinguished from the channel 112 through two or more features. For example, the outflow end 116 may begin where a tapered surface 136a of the channel 112 essentially stops tapering (relative to the rotational axis X). For example, the stator housing 104 may include a distal external surface 134a that is angled (e.g., essentially

[0171] - 32 -

[0172] 4867-4113-8494, v. 1 perpendicular) relative to the rotational axis X and / or the external surfaces 138 of the outflow end 116. Similarly, the inflow end 114 may be distinguished from the channel 112 through two or more features. For example, the inflow end 114 may begin where another tapered surface 136b of the channel 112 essentially stops tapering (relative to the rotational axis X). For example, the stator housing 104 may include another distal external surface 134b that is angled (e.g., essentially perpendicular) relative to the rotational axis X and / or the external surfaces 140 of the inflow end 114. The external surfaces 138, 140 of the outflow and inflow ends 114, 116 may be configured to connect with a pump hose (not shown) that is detachable from the blood pump 100.

[0173]

[0108] FIG. 2A is a cross-sectional view of a bloom pump 200. FIG. 2B is a zoomed in view of the cross-sectional view of the blood pump 200 of FIG. 2 A within box IIB. The blood pump 200 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200 of FIGS. 1-2B may be similar or include components from the other of the blood pumps 100, 200. The blood pump 200 includes an electrical housing 202 and a stator housing 204 that are connected and contain the components of the blood pump 200. A cable assembly 206 provides power and communication to a printed circuit board 208 that electrically controls operation of a rotor 210. As the rotor 210 rotates, blood or other fluids are moved through a channel 212 from an inlet end 214 to an outlet end 216 at a desirable blood flow. As the rotor 210 rotates relative to the rotational axis X, an impeller section 218 of the rotor moves blood with an impeller blade 220 such that blood moves towards and along a body 222 of the rotor 210. The blood continues to move towards the tail section 224 that is angled relative to the body 222 such that the flow of blood is maintained at a desirable rate. Tail stator fins 226 that extend along the tail section 224 and connect with inner surfaces 228 of the stator housing 204 help facilitate blood flow out of the blood pump 200 by remaining fixed as the rotor 210 rotates. The inner surface 228 extends between the inflow and outflow ends 214, 216 and define the channel 212. The inner surfaces 228 are tapered at or proximate to the inflow and outflow ends 214, 216 to facilitate blood flow around the rotor 210. The channel 212, the inflow end 214, and the outflow end 216 may collectively be referred to as an annular pathway configured to facilitate the flow of blood into and out of the blood pump 200. At either end of the annular pathway, the inflow and outflow ends 214, 216 may be configured to connect with a pump hose (not shown) that is removable.

[0174]

[0109] The tail section 224 tapers relative to the body 222 towards a convergence 230. The tail section 224 extends into the outflow end 216 to the convergence 230 at two angles - an initial angle A and a convergence angle B (e.g., a terminal and / or distal angle) sufficient to

[0175] - 33 -

[0176] 4867-4113-8494, v. 1 maintain or reduce the loss of the blood flow rate out of the blood pump 200. The initial angel A is measured as an angle relative to the rotational axis X and the initial portion 232. The convergence angle B is measured as an angle relative to the rotational axis X and the distal portion 134. The initial portion 232 begins at an initial edge 236, which separates the body 222 and the initial portion 232. The initial portion 232 extends to an intermediate edge 238 (e.g., transition edge) from which the distal portion 234 extends to the convergence 230. By having two separate tapered portions (e.g., the initial and distal portions 232, 234) the blood flow rate can be maintained and / or loss of blood flow rate can be mitigated when the rotor 210 is rotating relative to the channel 212 and / or rotational axis X.

[0177] [HO] The impeller section 218, the body 222, and the tail section 224 are connected together by a shaft 240. The shaft 240 is rotatably connected with the impeller and tail sections 218, 224 such that the body 222 fluidly seals internal components of the rotor 210. The rotational axis X intersects and extends through the shaft 240 and the rotor 210 rotates relative to the rotational X, desirably without tilt or wobbling.

[0178] [Hl] FIG. 4A is a cross-sectional view of a blood pump 400 with a removable sleeve 401. FIG. 4C is a cross-sectional view of the removable sleeve of FIG. 4A. The blood pump 400 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 400 of FIGS. 1-2B and 4A-4C may be similar or include components from the other of the blood pumps 100, 200, 400. The blood pump 400 includes an electrical housing 402 and a stator housing 404 that are connected and contain the components of the blood pump 400. A cable assembly 406 provides power and communication to a printed circuit board 408 that electrically controls operation of a rotor 410. As the rotor 410 rotates, blood or other fluids are moved through a channel 412 from an inlet end 414 to an outlet end 416 at a desirable blood flow. As the rotor 410 rotates relative to the rotational axis X, an impeller section 418 of the rotor moves blood with an impeller blade 420 such that blood moves towards and along a body 422 of the rotor 410. The blood continues to move towards the tail section 424 that is angled relative to the body 422 such that the flow of blood is maintained at a desirable rate. Tail stator fins 426 that extend along the tail section 424 and connect with inner surfaces 428 of the stator housing 404 help facilitate blood flow out of the blood pump 400 by remaining fixed as the rotor 410 rotates. The inner surface 428 extends between the inflow and outflow ends 414, 416 and define the channel 412. The inner surfaces 428 are tapered at or proximate to the inflow and outflow ends 414, 416 to facilitate blood flow around the rotor 410. The tail section 424 tapers relative to the body 422 towards a convergence 430. The tail

[0179] - 34 -

[0180] 4867-4113-8494, v. 1 section 424 further extends between the channel 412 and the outflow end 416 so that the blood flow rate is not undesirably lost as blood flows out of the blood pump 400.

[0181]

[0112] The impeller section 418, the body 422, and the tail section 424 are connected together by a shaft 440. The shaft 440 is rotatably connected with the impeller and tail sectioss 418, 424 such that the body 422 fluidly seals internal components of the rotor 410. The rotational axis X intersects and extends through the shaft 440 and the rotor 410 rotates relative to the rotational X, desirably without tilt or wobbling.

[0182]

[0113] The removable sleeve 401 provides a boost in blood flow rate after blood enters the channel 412, which is advantageous to save energy while operating the rotor 410. The removable sleeve 401 is removable from the channel 412 such that the blood pump 400 can be configured to have a boost or not depending on the organisms (e.g., patient or human). For example, the organism may be a child where a boost in blood flow rate may be undesirable. The removable sleeve 401 includes sleeve stator fins 432a, 432b, 432c that are configured to facilitate the blood and boost the blood flow rate entering the channel 412 without impacting the cells in the blood. The sleeve stator fins 432a, 432b, 432c are positioned within interior sleeve surfaces 434 that are configured to define the channel 412 (and portions of the annular pathway) when removable sleeve 401 is connected with the channel 412.

[0183]

[0114] The removable sleeve 401 connects with the channel 412 at exterior sleeve surfaces 436 that are essentially parallel relative to the interior surface 428 of the channel 412. To align the removable sleeve 401 and the sleeve stator fins 432a, 432b, 432c with the channel 412, an alignment feature 438, which may be configured as hook or flange, the holds the removable sleeve 401 in a predetermined positions so that the sleeve stator fins 432a, 432b, 432c do not undesirable contact or interfere with the impellers blade 420. When the removable sleeve 401 is fixed within the channel, the sleeve stator fins 432a, 432b, 432c are spaced a distance from the rotor 410 and / or the impeller section 418 such that the rotor 410 can rotate without contacting the sleeve stator fins 432a, 432b, 432c.

[0184]

[0115] The removable sleeve 401 includes an inlet 442 and outlet 444 that allows the removable sleeve to slide into and out of the channel 412 with or without the rotor 410 being present. Further, the removable sleeve 401 may be moved into the channel 412 by sliding through the inflow or outflow ends 414, 416 or by removing the inflow or outflow ends 414, 416, sliding the removable sleeve 401 within the channel 412, and reattached the inflow or outflow ends 414, 416.

[0185]

[0116] FIG. 5 A is a cross-sectional view of a blood pump 500 that includes shrouds. FIG. 5B is a cross-sectional view of another blood pump 501 that includes a strut. The blood pump

[0186] - 35 -

[0187] 4867-4113-8494, v. 1 500 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 500 of FIGS. 1-2B and 5 may be similar or include components from the other of the blood pumps 100, 200, 500. The blood pump 500 includes an electrical housing 502 and a stator housing 504 that are connected and contain the components of the blood pump 500. A cable assembly 506 provides power and communication to a printed circuit board 508 that electrically controls operation of a rotor 510. As the rotor 510 rotates, blood or other fluids are moved through a channel 512 from an inlet end 514 to an outlet end 516 at a desirable blood flow. As the rotor 510 rotates relative to the rotational axis X, an impeller section 518 of the rotor moves blood with an impeller shroud 520 such that blood moves towards and along a body 522 of the rotor 510. The blood continues to move towards the tail section 524 that is angled relative to the body 522 such that the flow of blood is maintained at a desirable rate. Tail stator fins 526 that extend along the tail section 524 and connect with inner surfaces 528 of the stator housing 204 help facilitate blood flow out of the blood pump 500 by remaining fixed as the rotor 510 rotates. The inner surface 528 extends between the inflow and outflow ends 514, 516 and define the channel 512. The inner surfaces 528 are tapered at or proximate to the inflow and outflow ends 514, 516 to facilitate blood flow around the rotor 510. The channel 512, the inflow end 514, and the outflow end 516 may collectively be referred to as an annular pathway configured to facilitate the flow of blood into and out of the blood pump 500. At either end of the annular pathway, the inflow and outflow ends 514, 516 may be configured to connect with a pump hose (not shown) that is removable. The tail section 524 tapers relative to the body 522 towards a convergence 530. The tail section 524 further extends between the channel 512 and the outflow end 516 so that the blood flow rate is not undesirably lost as blood flows out of the blood pump 500.

[0188]

[0117] Downstream of the impeller shroud 520, the flow straightener stator fins 542, which are stationary, are configured to protect cells of the blood and achieve desired blood flow rates as the blood travels towards a body impeller blade 534 of the body 522. As the body impeller blade 534 rotates, the blood flows towards channel stator fins 536 that are upstream of the tails section 524 within the channel 512 which facilitates blood flow out of the blood pump 500 at the outflow end 516. Adjacent to the tail stator fins 526 that overlay the tail section 524, one or more tail shroud(s) are configured to mitigate impact of the tail section 524 with the tail stator fins526 and / or other portions of the outflow end 516 and the channel 512 so that the tail section 524 is protected from impacts.

[0189]

[0118] In FIG. 5B, a touchdown cone 519 is configured to remain stationary relative rotational axis X so that, while the impeller section 518 rotates, the rotor 510 avoids contact

[0190] - 36 -

[0191] 4867-4113-8494, v. 1 with the channel 512 by being separated with a touchdown cone 519 and a strut 521. During rotation, the impeller section 518 may move axially, and the combination of the touchdown cone 519 and the strut 521 mitigate undesired contact, scratching, and / or impacting between rotor 510 and the channel 512 near the inflow end 514. The strut 521 may have any configuration or be made of any material sufficient to allow the rotor 510 to rotate without undesirable impacts against interior surfaces 528 of the channel 512. The strut 521 and the touchdown cone 519 may be connected with each other and / or to the interior surfaces 528 of the channel.

[0192]

[0119] FIG. 6 is a cross-sectional view of a rotor 600. The rotor 600 may be utilized with any one of the blood pumps 100, 200, 300, 500 of FIGS. 1-2B and 4A-5. The rotor 600 includes an impeller section 602, a body 604, and a tail section 606 that are connected by a shaft 608 such that internal components of the rotor 600 are fluidly sealed from the outside environment (e.g., the annular pathway or channel (not shown)).

[0193]

[0120] The rotor 600 includes magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh,

[0194] 61 Oi that are arranged around, contacted with, or connected with the shaft 608 such that when a magnetic field is applied to the rotor 600 the rotor can rotate relative to a rotational axis X that extends through the shaft 608. The some of the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi may be similar or the same as each other, and the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi may include one or more motor, bearing, and / or actuator magnets described herein. The magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 610h, 61 Oi are spaced from each other by a distance defined by spacers 612a, 612b. The magnets 610a, 610b, 610c, 610d, 610e, 610f, 610g, 610h, 610i and the spacers 612a, 612b extend around the shaft 608 and have a shape of a cylinder and / or ring.

[0195]

[0121] The spacers are configured to align the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi to desirable positions along the shaft 608. The spacers 612a, 612b in combination with interior surfaces 614 of the body 604 and the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi define spaces 616 that allow for greater size tolerance of the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi along the shaft 608. The spaces 616 may be in fluid communication with each other through gaps 618 between the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi and interior surfaces 614 of the body 604. Between the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi and either the impeller or tail sections 602, 606, additional gaps 620 are positioned along the shaft 608 and are free of the spacers 612a, 612b so that the shaft 608 has additional size tolerance for varying sizes of the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh,

[0196] - 37 -

[0197] 4867-4113-8494, v. 1 61 Oi . In some examples, the spacers 612a, 612b are positioned between one or more of the magnets 610a, 610b, 610c, 610d, 610e, 61 Of, 610g, 61 Oh, 61 Oi and either or both of the impeller and / or tail sections 602, 606.

[0198]

[0122] FIG. 7 is a cross-sectional view of a blood pump 700 including a rotor 702. The blood pump 700 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 400, 700 of FIGS. 1-2B, 4A-4C, and 7 may be similar or include components from the other of the blood pumps 100, 200, 400, 700. The rotor 702 may be implemented in any of the blood pumps 100, 200, 400, 700. The blood pump 700 includes a stator housing 704 that contains the components and provides an annular pathway for the rotor 702. The annular pathway is defined by an inflow end 706 that is fluidly connected with the channel 708 that leads to an outflow end 710 so that fluids can be circulated through the blood pump 700.

[0199]

[0123] The rotor 702 includes an impeller section 712, a body 714, and a tail section 716 that are connected by a shaft 718 so that the rotor 702 is rotatable relative to the rotational axis and the channel 708. The impeller section 712 includes an impeller blade 720 that rotates when the rotor rotates 702 so that blood is moved through the channel 70. The tail section 716 is overlay ed by tail stator fin 722 that remains fixed and is free of contact with the rotor 702 as the rotor 702 rotates.

[0200]

[0124] Inside of the rotor 702, the rotor includes a motor magnet 724 that separates two actuator magnets 726a, 726b. The actuator magnets 726a, 726b further separate front and rear pairs of bearing magnets 728a, 728b, 730a, 730b. The combination of the motor magnet 724, the actuator magnets 726a, 726b, and the front and rear pairs of bearing magnets 728a, 728b, 730a, 730b are configured to magnetically interact or interface with a motor coil 732, voice coils 734a, 734b, and front and rear pairs of stator magnets 736a, 736b, 738a, 738b. Because the voice coils 734a, 734b, and front and rear pairs of stator magnets 736a, 736b, 738a, 738b are magnetically balanced around the motor coil 732 and the actuator magnets 726a, 726b and the front and rear pairs of bearing magnets 728a, 728b, 730a, 730b are magnetically and mass balanced around the motor magnet 724, the rotor 702 can rotate relative to the shaft 718 and the rotational axis with minimal or no wobbling or tilt (e.g., affecting yaw, pitch, and / or roll) such that the rotor does not contact any surfaces or the tail stator fins 722 of the annular pathway.

[0201]

[0125] FIGS. 8A-8C are perspective views of a blood pump. The blood pump 800 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 400, 700, 800 of FIGS. 1-2B , 4A-4C, and 7-8C may be similar or include components from the other of the blood pumps 100, 200, 400, 700, 800. The blood pump 800 includes an electrical housing

[0202] - 38 -

[0203] 4867-4113-8494, v. 1 802 and a stator housing 804 that are connected and contain the components of the blood pump 800. The stator housing 804 includes inflow and outflow ends 806, 808 that in combination with a channel (not shown) form an annular pathway.

[0204]

[0126] A cable assembly 810 connects with the electrical housing 802 at a feedthrough assembly 812. The feedthrough assembly includes external and internal stanchions 814, 816 that support portions of the cable assembly 810. Specifically, the external stanchion 814 includes an opening 818 that allows the cable assembly 810 to extend through and be supported while connected with the electrical housing 802. The internal stanchion 816 includes apertures and feedthrough pins 820 that are configured to connect with the cables 822 of the cable assembly 810. The electrical pins 820 are horizontal relative to a rotational axis X so that the cables 822 can connect with the electrical pins 820 with minimal bending of the cables 822, which is advantageous to minimize signal noise due to bending of the cables 822.

[0205]

[0127] The cable assembly 810 is electrically connected and / or interfaced with a printed circuit board 824 that interfaces with the rotor (not shown) or the magnets and coils 826a, 826b, 826c, 826d, 826e, 826f (e.g., the voice coils, motor coils, and / or stator magnets). The printed circuit board 824 includes an axial portion 828, a flexible portion 830, and a base portion 832 that are configured to facilitate electrical signals from the cable assembly 810 to the electrical components 834a, 834b, 834c, 834d of the base portion 832. By utilizing a printed circuit board 824 within the electrical housing 802 instead of directly connecting cables 822 to the electrical components 834a, 834b, 834c, 834d, space is conserved within the electrical housing 802.

[0206]

[0128] To secure the printed circuit board 824 to the electrical and / or stator housings 802, 804, fasteners 836a, 836b, extend through and secure the printed circuit board 824 against the electrical and / or stator housings 802 at the base portion 832. At the feedthrough assembly 812, the axial portion 828 of the printed circuit board 824 is secured so that both the axial and base portions 828, 832 are secured to the blood pump 800.

[0207]

[0129] FIG. 9A is a cross-sectional view of a blood pump 900. FIG. 9B is a cross- sectional view of the blood pump 900 of FIG. 9 A. The blood pump 900 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 400, 700, 800, 900 of FIGS. 1-2B , 4A-4C, 7-8C, and 9A-9B may be similar or include components from the other of the blood pumps 100, 200, 400, 700, 800, 900. The blood pump 900 includes an electrical housing 902 and a stator housing 904 that are connected and contain the components of the blood pump 900.

[0208] - 39 -

[0209] 4867-4113-8494, v. 1

[0130] The stator housing 904 includes an annular pathway that includes an inflow end 906, an outflow end 908, and a channel 910 the contain a rotor 912. Around the rotor 912 and adjacent or proximate to the inflow end 906, one or more magnet sensors 914a, 914b, 914c are circumferentially spaced around the rotor 912 such that anomalies in rotation and magnetic fields around the rotor 912 are detectable. Magnetic fields may be shown in FIG.

[0210] 12. The one or more magnet sensors 914a, 914b, 914c may be evenly spaced around the rotational axis X and evenly spaced circumferentially around the rotational axis X relative to each other.

[0211]

[0131] The one or more magnet sensors 914a, 914b, 914c are disposed on a sensor circuit 916 that is connected with a printed circuit board 918. The printed circuit board 918 is configured to send information or data from the one or more magnet sensors 914a, 914b, 914c to external hardware through the cable assembly 920. The sensor circuit 916 is fluidly separated from the channel 910 and protected by the stator housing 804 such that the sensor circuit 916 does not undesirably contact or interact with the blood traveling through the blood pump 900. The sensor circuit 916 and the one or more magnet sensors 914a, 914b, 914c extend leghtwise (e.g., along the longest axis of each component) through and parallel with the y-axis Y and are generally extend perpendicular relative to the z-axis Z and the rotational axis X.

[0212]

[0132] The rotor 912 includes an impeller section 922 with an impeller blade 924, a body 926 extended through the channel 910, and a tail section 928 with a tail stator fin 930 overlaying the tail section 928. As the rotor 912 rotates, the one or more magnet sensors 914a, 914b, 914c can detect whether there are positional anomalies along the rotational axis X, z-axis Z, and y-axis Y. Additionally, the non-contact position sensors 914a, 914b, 914c may be configured to determine is magnetic anomalies are occurring at any one of the housing magnets and coils 932a, 932b, 932c, 932d, 932e, 932f, 932g (e.g., the voice coils, the motor coils, and / or the stator magnets) and / or the permanent magnets 934a, 934b, 934c, 934d, 934e, 934f, 934g, 934h.

[0213]

[0133] FIG. 10A is a cross-sectional view of a blood pump 1000. The blood pump 1000 may be referred to as a device, system, and / or apparatus. The blood pumps 100, 200, 400, 700, 800, 900, 1000 of FIGS. 1-2B , 4A-4C, 7-8C, and 9A-10D may be similar or include components from the other of the blood pumps 100, 200, 400, 700, 800, 900, 1000. The blood pump 1000 includes an electrical housing 1002 and a stator housing 1004 that are connected and contain the components of the blood pump 1000. The stator housing 1004 connects with a pump hose 1006a at a barb magnet ring 1008 and a stator magnet ring 1010

[0214] - 40 -

[0215] 4867-4113-8494, v. 1 that are releasable relative to each other. The barb magnet ring 1008 may be fully or partially integrated with the pump hose 1006 such that the pump hose 1006 may be removed from the blood pump 1000 to expose the inflow end 1012, the channel 1014, and the outflow end 1016 that contains the rotor 1018. The barbs 1020a, 1020b additionally provide a friction fit or rotatable fit for the pump hoses 1006a, 1006b so that fluids or blood is directed into the channel 1014 rather than outside of the blood pump. Similarly, the outflow end 1020 may include any combination of a barb magnet ring and stator magnet ring (not shown) to releasable remove the pump hose 1006b.

[0216]

[0134] FIGS. 10B-D are cross-sectional views of the blood pump 1000 of FIG. 10A illustrating different configurations of a magnetically connected pumping hose. Any releasable magnet configuration may be utilized to connect the pump hose 1006a and the blood pump 1000. For example, FIG. 10B illustrates a circumferentially symmetric configuration. FIG. 10C illustrates a segmented magnetic configuration. FIG. 10D illustrates an alternating magnetization.

[0217]

[0135] FIG. 11 illustrates a desirable configuration of magnets and magnet stacks for a rotor. The illustration of FIG. 11 may be relevant to any one of the rotors 110, 210, 410, 510, 600, 702, 912, 1018.

[0218]

[0136] While the disclosure has been described in connection with certain embodiments, it is to be understood that the disclosure is not to be limited to the disclosed embodiments but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the scope of the appended claims, which scope is to be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures as is permitted under the law.

[0219] ILLUSTRATIVE STATEMENTS

[0220]

[0137] Statement sets A through J are illustrative of all concepts disclosed in this application. Elements or portions of statement sets A through J may be used interchangeably with other of statement sets A through J.

[0221] STATEMENT A

[0222] AL A blood pump, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; and

[0223] - 41 -

[0224] 4867-4113-8494, v. 1 an outflow end of the flow path providing for exit of the blood through an outflow conduit; wherein the rotor includes an inflow element having at least one blade and forming a flow path divergence, an outflow element forming a flow path convergence, and a body extending between the inflow element and the outflow element, the inflow element and the outflow element being provided at opposite ends of a shaft; wherein the length of the outflow element in an axial direction is greater than a length of the inflow element.

[0225] A2. A blood pump of statement Al, wherein the blood pump is a circulatory assist device configured to support a heart, such as, for example, a ventricular assist device (VAD), or the like. In various examples, the blood pump is configured to support circulation of a human heart. In various examples, the blood pump is implantable.

[0226] A3. A blood pump of any one of statements A1-A2, wherein the rotor is a magnetically- levitated rotor driven to rotate by interaction between one or more motor magnets disposed within the rotor and a motor coil disposed within the pump housing around the annular flow path.

[0227] A4. A blood pump according to any one of the preceding statements, wherein the inflow element and / or the outflow element may be connected to the shaft by mechanical means, such as, for example, welding, adhesive, friction fitting, threading, one or more fasteners, or the like. In various examples, the inflow element or the outflow element may be integrally formed with the shaft.

[0228] A5. A blood pump according to any one of the preceding statements, wherein the axial length of the outflow element provides a gradual reduction of cross-sectional area of the annular flow path. In various examples, the cross-sectional area reduces from about 57 mm2to about 38 mm2over a length of about 14 mm.

[0229] A6. A blood pump according to any one of the preceding statements, wherein the length of the outflow element in the axial direction of the shaft is greater than about 2 times longer than a length of the inflow element. In various examples, the length of the outflow element in the axial direction of the shaft is about 2.5 times longer than the length of the inflow element.

[0230] A7. A blood pump according to any one of the preceding statements, wherein a convergence angle of the outflow element is less than a divergence angle of the inflow element.

[0231] A8. A blood pump according to any one of the preceding statements, wherein the convergence angle of the outflow element is about 15 degrees to about 30 degrees, including all 0.1 degree values and ranges therebetween, such as, for example about 20 degrees.

[0232] - 42 -

[0233] 4867-4113-8494, v. 1 A9. A blood pump according to any one of the preceding statements, wherein the convergence angle and the divergence angle are half angles, in which an inclusive angle is twice the half angle.

[0234] A10. A blood pump according to any one of the preceding statements, wherein an exemplary convergence angle (half angle) of about 15 degrees corresponds an inclusive angle of about 30 degrees:

[0235] All. A blood pump according to any one of the preceding statements, wherein the convergence angle is consistent along the length of the outflow element.

[0236] A12. A blood pump according to any one of the preceding statements, wherein wherein the outflow element comprises a first portion connected to the body of the rotor and a second portion connected to the first portion, the first portion having the convergence angle that is less than the divergence angle of the inflow element.

[0237] Al 3. A blood pump according to any one of the preceding statements, wherein the first portion and the second portion are integrally formed as the outflow element and provide a compound angle. In various examples, the compound angle limits axial travel while preserving overall length of the outflow element.

[0238] A14. A blood pump according to any one of the preceding statements, wherein the first portion and the second portion are conicical sections. In various examples, the second portion has a convergence angle that is greater than the convergence angle of the first portion, which limits axial travel and / or the convergence angle of the second portion is greater than the divergence angle of the inflow element and / or or the tail angle of the second portion is about 50 degrees to about 60 degrees, including all 0.1 degree values and ranges therebetween, such as, for example, 55 degrees.

[0239] A14. A blood pump according to any one of the preceding statements, wherein a length of the second portion in the axial direction of the shaft is less than a length of the first portion in the axial direction of the shaft.

[0240] Al 5. A blood pump according to any one of the preceding statements, wherein the length of the second portion in the axial direction of the shaft is less than about half of the length of the outflow element or wherein the length of the second portion in the axial direction of the shaft is about 1 / 3 of the length of the outflow element.

[0241] Al 6. A blood pump according to any one of the preceding statements, wherein exemplary shapes of the outflow element or tail section include any multicone structure including bicone, tricone, quadcone, pentacone, hexacone, heptacone, octacone, nonacone, and / or dicone having intermediate edges or convergence points between each of the stacked cones.

[0242] - 43 -

[0243] 4867-4113-8494, v. 1 Al 7. A blood pump according to any one of the preceding statements, further comprising stationary stator blades provided on the inner surface of the pump housing in the outlet end of the flow path surrounding the outlet element.

[0244] Al 8. A blood pump according to any one of the preceding statements, wherein the stationary stator blades are conformal (e.g., parallel) to a profile (e.g., the convergence angle) of the outflow element.

[0245] Al 9. A blood pump according to any one of the preceding statements, the outflow element is comprised of a tough elastomeric material (such as, for example, silicone rubber, or the like, polyurethanes, or any blood-compatible, elastomer with good anti-tear toughness) to prevent damage in the event of contact with the stationary inward-pointed stator blades.

[0246] A20. A blood pump according to any one of the preceding statements, the outflow element is comprised of or coated with a hard material (such as, for example, a ceramic material, alumina, ruby, zirconia, pyrolytic carbon, or the like) to resist damage in the event of contact with the stationary inward-pointed stator blades.

[0247] STATEMENT B

[0248] Bl. A blood pump optionally including any of statements A, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; an exterior housing, the exterior housing having a dome and a cable assembly for enclosing electrical interconnections within the blood pump, the cable assembly including a feed-through body, the cable assembly being parallel to and laterally offset from a central axis of the outflow conduit; and a circuit board disposed within the dome, the circuit board including a first rigid portion and a second rigid portion connected by a flexible portion, the first rigid portion being parallel to and axially offset from the feed-through body.

[0249] B2. A blood pump according to statement Bl, wherein the circuit board is secured to the pump housing and covered by the dome of the exterior housing and / or the circuit board is disposed within a cavity that is hermetically sealed by the exterior housing.

[0250] - 44 -

[0251] 4867-4113-8494, v. 1 B3. A blood pump according to statements Bl -B2, wherein the second rigid portion is orthogonal to the first rigid portion.

[0252] B3. A blood pump according to any one of the preceding statements, wherein the second rigid portion is disposed at an angle relative to the first rigid portion of about 85 degrees to about 95 degrees, including all 0.1 degree values and ranges therebetween, such as, for example, 90 degrees.

[0253] B4. A blood pump according to any one of the preceding statements, wherein the second rigid portion is arranged parallel to the central axis of the outflow conduit.

[0254] B5. A blood pump according to any one of the preceding statements, wherein providing the second rigid portion at a substantially right angle relative to the first rigid portion saves space within the dome.

[0255] B6. A blood pump according to any one of the preceding statements, wherein the first rigid portion includes a plurality of feedthrough terminations axially aligned with the feed-through body and configured to connect to a cable received by the feed-through body of the cable assembly.

[0256] B7. A blood pump according to any one of the preceding statements, further comprising: a motor magnet assembly disposed within the rotor; and a motor coil disposed within the pump housing around the annular flow path, the motor coil being configured to drive the rotor to rotate within the pump housing based on interaction with the motor magnet assembly; wherein the second rigid portion includes at least one motor termination radially aligned with the annular flow path and electrically connected to corresponding terminations of the plurality of feedthrough terminations via the flexible portion, and the motor coil being connected to the at least one motor termination.

[0257] B8. A blood pump according to any one of the preceding statements, further comprising: at least one permanent magnet assembly disposed within the rotor; and at least one voice coil disposed within the pump housing around the annular flow path, the at least one voice coil being configured to stabilize the rotor in the axial direction based on interaction with the at least one permanent magnet assembly; wherein the second rigid portion includes at least one voice coil termination radially aligned with the annular flow path and electrically connected to corresponding terminations of the plurality of feedthrough terminations via the flexible portion, and the at least one voice coil being connected to the at least one voice coil termination.

[0258] B9. A blood pump according to any one of the preceding statements, further comprising:

[0259] - 45 -

[0260] 4867-4113-8494, v. 1 a first sensor coil provided at the inflow end of the flow path and a second sensor coil provided at the outflow end of the flow path, the first sensor coil and the second sensor coil being configured to detect axial movement of the rotor based on interaction with at least one permanent magnet assembly disposed within the rotor; wherein the second rigid portion includes a first sensor coil termination and a second sensor coil termination radially aligned with the annular flow path and electrically connected to corresponding ones of the plurality of feedthrough terminations via the flexible portion, the first sensor coil being connected to the first sensor coil termination, and the second sensor coil being connected to the second sensor coil termination.

[0261] STATEMENT C

[0262] Cl. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor assembly; a motor coil disposed within the pump housing around the annular flow path; an inflow end of the flow path providing for entry of blood through an inflow conduit; and an outflow end of the flow path providing for exit of the blood through an outflow conduit; wherein the rotor assembly comprises: an impeller body; a nose cone connected to the impeller body at the inflow end and having at least one blade; a tail cone connected to the impeller body at the outflow end; a shaft connected to the nose cone and the tail cone and extending through the impeller body; and a motor magnet assembly connected to the shaft and coaxial with the nose cone and the tail cone, the motor coil being configured to drive the rotor assembly to rotate within the pump housing based on interaction with the motor magnet assembly; wherein the motor magnet assembly is disposed within the impeller body such that an annular gap is provided between an inner diameter of the impeller body and an outer diameter of the motor magnet assembly.

[0263] C2. A blood pump according to statement C3, wherein the annular gap provides a tolerance for the outer diameter of the motor magnet assembly and / or wherein the annular gap is

[0264] - 46 -

[0265] 4867-4113-8494, v. 1 provided in a range of about 0.025 mm to about 0.10 mm, including all 0.001 mm values and ranges therebetween.

[0266] C3. A blood pump according to statements C1-C2, wherein the shaft is threadably connected to at least one of the nose cone or the tail cone.

[0267] C4. A blood pump according to any one of the preceding statements, wherein the motor magnet assembly may comprise two to eight magnets circumferentially arranged around the shaft. In various examples, the motor magnet assembly is comprised of four magnets circumferentially arranged around the shaft. In various examples, each of the four magnets has a magnetization direction outward, away from the axis of shaft.

[0268] C5. A blood pump according to any one of the preceding statements, further comprising: at least one voice coil disposed within the pump housing around the annular flow path, the at least one voice coil being configured to stabilize the rotor in the axial direction based on interaction with the at least one permanent magnet; wherein the rotor assembly further comprises: at least one permanent magnet assembly connected to the shaft and coaxial with the motor magnet assembly, the at least one voice coil being configured to stabilize the rotor assembly in the axial direction based on interaction with the at least one permanent magnet assembly; wherein the at least one permanent magnet assembly is disposed within the impeller body such that the annular gap is further provided between the inner diameter of the impeller body and an outer diameter of the at least one permanent magnet assembly. C6. A blood pump according to any one of the preceding statements, the at least one permanent magnet assembly comprises an annular magnet assembly and four axially magnetized magnets circumferentially arranged around the shaft provided on each side of the annular magnet assembly and / or the annular magnet assembly has a magnetization direction toward the inflow end of the flow path and / or the four magnets on the inflow side of the annular magnet assembly have a magnetization direction away from the shaft and / or the four magnets on the outflow side of the annular magnet assembly have a magnetization toward the shaft axis.

[0269] C7. A blood pump according to any one of the preceding statements, the annular magnet assembly comprises a plurality of segments (e.g. pie slices), each magnetized radially. In various examples, the plurality of segments comprises four segments.

[0270] C8. A blood pump according to any one of the preceding statements, wherein the configuration of magnets is described in a configurations of magnets of the at least one

[0271] - 47 -

[0272] 4867-4113-8494, v. 1 permanent magnet assembly and magnetizations thereof are possible, as described in Paden BE, NJ Groom, JF Antaki. Design formulae for permanent magnet bearings. ASME

[0273] J Mechanical Design, 125:734-738, 2003, the entire disclosure of which is hereby incorporated by reference herein.

[0274] C9. A blood pump according to any one of the preceding statements, a spacer is provided between the motor magnet assembly and the at least one permanent magnet assembly. In various examples, the spacer is connected to the shaft.

[0275] CIO. A blood pump according to any one of the preceding statements, further comprising: a first stator magnet assembly disposed within the pump housing around the inflow end of the flow path; and a second stator magnet assembly disposed within the pump housing around the outflow end of the flow path; wherein the rotor assembly further comprises: a first bearing magnet assembly connected to the shaft adjacent to the nose cone and coaxial with the motor magnet assembly, the first stator magnet assembly being configured to stabilize the rotor assembly in the radial direction based on interaction with the first bearing magnet assembly; and a second bearing magnet assembly connected to the shaft adjacent to the tail cone and coaxial with the motor magnet assembly, the second stator magnet assembly being configured to stabilize the rotor assembly in the radial direction based on interaction with the second bearing magnet assembly; wherein the first bearing magnet assembly and the second bearing magnet assembly are disposed within the impeller body such that the annular gap is further provided between the inner diameter of the impeller body and an outer diameter of the first bearing magnet assembly and the second bearing magnet assembly.

[0276] Cll. A blood pump according to any one of the preceding statements, wherein the first stator magnet assembly comprises two annular magnet assemblies and the first bearing magnet assembly comprises two annular magnet assemblies and / or the second stator magnet assembly comprises two annular magnet assemblies and the second bearing magnet assembly comprises two annular magnet assemblies and / or each annular magnet assembly of the first stator magnet assembly has the same magnetization direction as a corresponding annular magnet assembly of the first bearing magnet assembly, and each annular magnet assembly of the second stator magnet assembly has the same magnetization direction as a corresponding annular magnet assembly of the second bearing magnet assembly and / or one annular magnet

[0277] - 48 -

[0278] 4867-4113-8494, v. 1 assembly of the first stator magnet assembly and one annular magnet assembly of the second stator magnet assembly have a magnetization direction toward the inflow end of the flow path and / or one annular magnet assembly of the first stator magnet assembly and one annular magnet assembly of the second stator magnet assembly have a magnetization direction toward the outflow end of the flow path.

[0279] Cll. A blood pump according to any one of the preceding statements, wherein a spacer is provided between the motor magnet assembly and the first bearing magnet assembly and / or the spacer is connected to the shaft.

[0280] STATEMENT D:

[0281] DI. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor assembly; a motor coil disposed within the pump housing around the annular flow path; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; a first voice coil disposed within the pump housing around the annular flow path adjacent to the motor coil and nearer to the inflow end of the flow path; and a second voice coil disposed within the pump housing around the annular flow path adjacent to the motor coil and nearer to the outflow end of the flow path; wherein the rotor assembly comprises: an impeller body; a nose cone connected to the impeller body nearest to the inflow end of the flow path and having at least one blade; a tail cone connected to the impeller body nearest to the outflow end of the flow path; a shaft connected to the nose cone and the tail cone and extending through the impeller body; a motor magnet assembly connected to the shaft and coaxial with the nose cone and the tail cone, the motor coil being configured to drive the rotor assembly to rotate within the pump housing based on interaction with the motor magnet assembly;

[0282] - 49 -

[0283] 4867-4113-8494, v. 1 a first magnet assembly connected to the shaft and coaxial with the motor magnet assembly, the first voice coil being configured to stabilize the rotor assembly in the axial direction based on interaction with the first magnet assembly; and a second magnet assembly connected to the shaft and coaxial with the motor magnet assembly, the second voice coil being configured to stabilize the rotor assembly in the axial direction based on interaction with the second magnet assembly.

[0284] D2. A blood pump according to statement DI, wherein the impeller body is a cylindrical shell enclosing the magnet assemblies and / or the nose cone or the tail cone is integrally formed with the cylindrical shell and / or the nose cone and / or the tail cone is a separate element that is affixed to (e.g., welded or bonded) the cylindrical shell.

[0285] D3. A blood pump according to statements DI or D2, wherein the rotor assembly mass balanced on its axis of rotation for improved stability during rotation and / or the arrangement of the motor magnet assembly, the first magnet assembly, and the second magnet assembly is symmetrical, thereby balancing the pitch / yaw forces acting on the rotor assembly.

[0286] D4. A blood pump according to any one of the preceding statements, wherein the motor magnet assembly is centrally disposed on the shaft and / or the motor magnet assembly is centrally disposed between the nose cone and the tail cone and / or the motor magnet assembly has a magnetization direction perpendicular to the shaft axis.

[0287] D5. A blood pump according to any one of the preceding statements, wherein the first magnet assembly is provided on the shaft adjacent to the motor magnet assembly and nearer to the inflow end of the flow path, and the second magnet assembly is provided on the shaft adjacent to the motor magnet assembly and nearer to the outflow end of the flow path and / or the first magnet assembly and the second magnet assembly are annular magnet assemblies and / or the first magnet assembly has a magnetization direction toward the inflow end of the flow path and the second magnet assembly has a magnetization direction toward the outflow end of the flow path.

[0288] D6. A blood pump according to any one of the preceding statements, wherein a first spacer is provided between the motor magnet assembly and the first magnet assembly, and a second spacer is provided between the motor magnet assembly and the second magnet assembly. In various examples, the first spacer and / or the second spacer are connected to the shaft.

[0289] D7. A blood pump according to any one of the preceding statements, further comprising: a first stator magnet assembly disposed within the pump housing around the inflow end of the flow path adjacent to the first voice coil; and

[0290] - 50 -

[0291] 4867-4113-8494, v. 1 a second stator magnet assembly disposed within the pump housing around the outflow end of the flow path adjacent to the second voice coil; wherein the rotor assembly further comprises: a first bearing magnet assembly connected to the shaft adjacent to the nose cone and coaxial with the motor magnet assembly, the first stator magnet assembly being configured to stabilize the rotor assembly in the radial direction based on interaction with the first bearing magnet assembly and the first magnet assembly; and a second bearing magnet assembly connected to the shaft adjacent to the tail cone and coaxial with the motor magnet assembly, the second stator magnet assembly being configured to stabilize the rotor assembly in the radial direction based on interaction with the second bearing magnet assembly and the second magnet assembly.

[0292] D8. A blood pump according to any one of the preceding statements, wherein the first stator magnet assembly comprises two annular magnet assemblies and the first bearing magnet assembly comprises two annular magnet assemblies and / or the second stator magnet assembly comprises two annular magnet assemblies and the second bearing magnet comprises two annular magnet assemblies and / or each annular magnet assembly of the first stator magnet assembly has the same magnetization direction as a corresponding annular magnet assembly of the first bearing magnet assembly, and each annular magnet assembly of the second stator magnet assembly has the same magnetization direction as a corresponding annular magnet assembly of the second bearing magnet assembly and / or one annular magnet assembly of the first stator magnet assembly and one annular magnet assembly of the second stator magnet assembly have a axially magnetization direction toward the inflow end of the flow path and / or one annular magnet assembly of the first stator magnet assembly and one annular magnet assembly of the second stator magnet assembly have a axially magnetization direction toward the outflow end of the flow path.

[0293] STATEMENT E:

[0294] El. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; and

[0295] - 51 -

[0296] 4867-4113-8494, v. 1 at least one magneto-resistive sensor provided at the inflow end and configured to detect an axial position of the rotor based on interaction with at least one permanent magnet assembly disposed within the rotor.

[0297] E2. A blood pump according to statement El, wherein the at least one magneto-resistive sensor is an axial sensor, an angular sensor, or a multi-axis sensor and / or the at least one magneto-resistive sensor has dimensions of about 3 mm x about 3 mm x about 1.5 mm or less and / or the at least one magneto-resistive sensor has dimensions of about 3 mm x about 3 mm x about 1.45 mm.

[0298] E3. A blood pump according to any one of the statements E2 - E3, the at least one magnetoresistive sensor is an encapsulated package sensor.

[0299] E4. A blood pump according to any one of the preceding statements, wherein the at least one magneto-resistive sensor comprises a thin film of magneto-resistive material including an alloy, such as, for example, InSb, InAs, or GaAs.

[0300] E5. A blood pump according to any one of the preceding statements, further comprising: a circuit board disposed parallel to and laterally offset from a central axis of the inflow conduit; and a board extension connected to the circuit board and extending toward the central axis of the inflow conduit; wherein the at least one magneto-resistive sensor is disposed on the board extension and electrically connected to the circuit board.

[0301] E6. A blood pump according to any one of the preceding statements, wherein the board extension extends from the circuit board at an angle of about 85 degrees to about 95 degrees, including all 0.1 degree values and ranges therebetween, such as, for example, 90 degrees. E7. A blood pump according to any one of the preceding statements, wherein the at least one magneto-resistive sensor disposed on the board extension is aligned with the magnetic field of the at least one permanent magnet assembly being measured (e.g., a front-most (i.e., toward the inflow end) permanent magnet in the rotor) and / or the at least one magnetoresistive sensor is aligned with the magnetic field of the at least one permanent magnet assembly being measured at an angle of about 0 degrees to about 90 degrees, including all 0.1 degree values and ranges therebetween, such as, for example, 0 degrees or 90 degrees.

[0302] E8. A blood pump according to any one of the preceding statements, wherein the at least one magneto-resistive sensor is configured detect a change in magnetic field strength and a direction (i.e., vector) of the magnetic field of the at least one permanent magnet assembly being measured.

[0303] - 52 -

[0304] 4867-4113-8494, v. 1 E9. A blood pump according to any one of the preceding statements, wherein exemplary angles of the at least one magneto-resistive sensor (90 degrees and 0 degrees) are provided below:

[0305] E10. A blood pump according to any one of the preceding statements, wherein the board extension has a thickness of about 0.3 mm to about 0.6 mm, including all 0.01 mm values therebetween.

[0306] Ell. A blood pump according to any one of the preceding statements, wherein the at least one magneto-resistive sensor comprises at least two magneto-resistive sensors circumferentially spaced around the inflow end of the flow path.

[0307] E12. A blood pump according to any one of the preceding statements, wherein at least two magneto-resistive sensors are disposed on the board extension. In various examples, the at least two magneto-resistive sensors comprise two magneto-resistive sensors circumferentially spaced about 180 degrees apart or about 90 degrees apart around the inflow end of the flow path.

[0308] El 3. A blood pump according to any one of the preceding statements, wherein the at least two magneto-resistive sensors comprise three magneto-resistive sensors circumferentially spaced about 120 degrees apart around the inflow end of the flow path.

[0309] E14. A blood pump according to any one of the preceding statements, wherein each of the three magneto-resistive sensors has dimensions of about 3 mm x about 3 mm x about 0.45 mm.

[0310] STATEMENT F:

[0311] Fl. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; and a sleeve inserted into the annular flow path against the inner surface of the pump housing, the sleeve including at least one blade extending toward the outer surface of the rotor.

[0312] F2. A blood pump according to statement Fl, wherein the sleeve is manufactured by an additive manufacturing process, such as, for example, 3D printing, investment casting,

[0313] - 53 -

[0314] 4867-4113-8494, v. 1 electroforming, or the like, or a subtractive manufacturing process, such as, for example, CNC machining or the like.

[0315] F3. A blood pump according to statements Fl or F2, wherein the at least one blade is arranged on the sleeve nearer to the inflow end of the flow path than the outflow end of the flow path.

[0316] F4. A blood pump according to any one of the preceding statements, wherein the at least one blade is arranged in the sleeve at an axial position that is configured for optimal flow efficiency within a flow range and / or the optimal flow efficiency may be configured for a nominal flow rate of an adult (such as, for example, 5 L / min), a young child (such as, for example, 1.5 L / min), or others having higher or lower nominal flow rates and / or the flow range is about 0.5 L / min to about 5 L / min, including all 0.1 values and ranges therebetween, such as, for example, about 0.5 L / min to about 3 L / min, about 1 L / min to about 2 L / min, about 2 to about 3 L / min, 1.5 L / min, 2.5 L / min, 5L / min.

[0317] F5. A blood pump according to any one of the preceding statements, 24. A blood pump according to claim 22 or 23, wherein the sleeve further includes a flange defined nearer to the outflow end of the flow path, and the sleeve is insertable toward the inflow end of the flow path from the outflow end of the flow path such that the flange abuts against the pump housing and the outflow conduit.

[0318] F6. A blood pump according to any one of the preceding statements, the blood pump has an optimal flow efficiency within a first flow range with the sleeve not inserted into the annular flow path, and the blood pump has an optimal flow efficiency within a second flow range with the sleeve inserted into the annular flow path, with the second flow range being greater than the first flow range and / or the first flow range and the second flow range may be nonoverlapping.

[0319] F7. A blood pump according to any one of the preceding statements, the sleeve is a first sleeve, and a second sleeve is provided that is exchangeable with the first sleeve, the second sleeve being configured for optimal flow efficiency in a flow range that is different from that of the first sleeve and / or the second sleeve includes at least one blade arranged at a different position or with a different wrap angle from the at least one blade of the first sleeve.

[0320] STATEMENT G:

[0321] Gl. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor;

[0322] - 54 -

[0323] 4867-4113-8494, v. 1 an inflow end of the flow path providing for entry of blood through an inflow conduit; and an outflow end of the flow path providing for exit of the blood through an outflow conduit; wherein the rotor includes an inflow element having at least one blade and forming a flow path divergence, an outflow element forming a flow path convergence, and a body extending between the inflow element and the outflow element; and wherein the rotor further includes an inlet shroud extending over a portion of each blade of the inflow element, the inlet shroud being conformal to the inner surface of the pump housing.

[0324] G2. A blood pump according to statement Gl, wherein the inlet shroud is configured to protect the tips of each blade of the inflow element from damage due to contact with the inner surface of the pump housing.

[0325] G3. A blood pump according to statements Gl or G2, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; and an outflow end of the flow path providing for exit of the blood through an outflow conduit; wherein the rotor includes an inflow element having at least one blade and forming a flow path divergence, an outflow element forming a flow path convergence, and a body extending between the inflow element and the outflow element; wherein at least one stator blade is provided on the inner surface of the pump housing in the outlet end of the flow path surrounding the outlet element and extending towards an axis of the rotor; and wherein the rotor further includes an outlet shroud extending along a portion of the at least one stator blade and is conformal to the outflow element of the rotor.

[0326] G4. A blood pump according to any one of the preceding statements, wherein the outlet shroud is configured to protect the tips of each stator blade from damage due to contact with the outer surface of the rotor.

[0327] STATEMENT H

[0328] Hl. A blood pump, optionally according to any one of the preceding statements, comprising:

[0329] - 55 -

[0330] 4867-4113-8494, v. 1 an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; an inlet hose barb magnetically connected to the pump housing and in fluid communication with the inflow conduit; and an outlet hose barb magnetically connected to the pump housing and in fluid communication with the outflow conduit.

[0331] H2. A blood pump according to Hl, wherein the inlet hose barb and the outlet hose barb are configured for connection to flexible tubing for circulation of blood through the blood pump. H3. A blood pump according to Hl or H2, wherein the inlet hose barb is provided with an inlet barb magnet assembly which is magnetically affixed to an inlet housing magnet assembly or an inlet paramagnetic material provided in the pump housing at the inflow end of the flow path.

[0332] H4. A blood pump according to any one of the preceding statements, wherein the outlet hose barb is provided with an outlet barb magnet assembly which is magnetically affixed to an outlet housing magnet assembly or an outlet paramagnetic material provided in the pump housing at the outflow end of the flow path.

[0333] H5. A blood pump according to any one of the preceding statements, wherein the inlet barb magnet assembly and the inlet housing magnet assembly each comprise an annular magnet assembly having opposite magnetization directions along an axis of the rotor.

[0334] H6. A blood pump according to any one of the preceding statements, wherein the outlet barb magnet assembly and the outlet housing magnet assembly each comprise an annular magnet assembly having opposite magnetization directions along an axis of the rotor.

[0335] H7. A blood pump according to any one of the preceding statements, wherein each of the annular magnet assemblies comprises at least two arcuate segments having alternating magnetization directions.

[0336] STATEMENT I

[0337] 11. A blood pump, optionally according to any one of the preceding claims, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor assembly;

[0338] - 56 -

[0339] 4867-4113-8494, v. 1 an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; a first stator magnet assembly disposed within the pump housing around the inflow end of the flow path; and a second stator magnet assembly disposed within the pump housing around the outflow end of the flow path; wherein the rotor assembly comprises: a first bearing magnet assembly disposed at the inflow end of the flow path, wherein the first stator magnet assembly is configured to stabilize the rotor assembly in the radial direction based on interaction with the first bearing magnet assembly; and a second bearing magnet assembly disposed at the outflow end of the flow path, wherein the second stator magnet assembly is configured to stabilize the rotor assembly in the radial direction based on interaction with the second bearing magnet assembly; wherein each of the first bearing magnet assembly and the second bearing magnet assembly comprises a stack of magnetic rings, and each magnetic ring of the stack of magnetic rings is rotationally offset from each other ring of the stack of magnetic rings, which balances the magnetic field of each of the first bearing magnet assembly and the second bearing magnet assembly.

[0340] 12. A blood pump, optionally according to any one of the preceding statements, comprising: an annular flow path defined between an inner surface of a pump housing and an outer surface of a rotor assembly; an inflow end of the flow path providing for entry of blood through an inflow conduit; an outflow end of the flow path providing for exit of the blood through an outflow conduit; a first stator magnet assembly disposed within the pump housing around the inflow end of the flow path; and a second stator magnet assembly disposed within the pump housing around the outflow end of the flow path; wherein the rotor assembly comprises:

[0341] - 57 -

[0342] 4867-4113-8494, v. 1 a first bearing magnet assembly disposed at the inflow end of the flow path, wherein the first stator magnet assembly is configured to stabilize the rotor assembly in the radial direction based on interaction with the first bearing magnet assembly; and a second bearing magnet assembly disposed at the outflow end of the flow path, wherein the second stator magnet assembly is configured to stabilize the rotor assembly in the radial direction based on interaction with the second bearing magnet assembly; wherein each of the first bearing magnet assembly and the second bearing magnet assembly comprises a stack of magnetic rings including a shimming magnet, and the shimming magnet of the stack of magnetic rings has an eccentric magnetic field, which balances the magnetic field of each other ring of the stack of magnetic rings of each of the first bearing magnet assembly and the second bearing magnet assembly.

[0343] STATEMENT J

[0344] JI. A device, comprising: a. an annular pathway comprising: i. a channel defined within a housing; ii. an inflow end configured to facilitate blood flow into the channel; and iii. an outflow end configured to facilitate blood flow out of the channel; b. a rotor disposed within the channel, the rotor comprising: i. a body; ii. an impeller section connected with the body; and iii. a tail section connected with the body that tapers to a convergence; and c. one or more tail stator fin(s) that overlay the tail section; wherein the device further comprises a removable sleeve disposed within the channel, the removable sleeve comprising one or more sleeve stator fin(s) positioned at the body, the one or more sleeve stator fin(s) configured to increase blood flow within the channel; wherein the tail section extends into both of the outflow end and the channel along a rotational axis; and / or wherein the tail section has a tail length that is longer than an impeller length of the impeller section along the rotational axis.

[0345] J2. A device of any one of the preceding statements, wherein the tail section has a tail angle with respect to the rotational axis that is 40 degrees or less.

[0346] J3. A device of any one of the preceding statements, wherein the tail section has a tail angle with respect to the rotational axis that is 20 degrees or less.

[0347] - 58 -

[0348] 4867-4113-8494, v. 1 J4. A device of any one of the preceding statements, wherein tail section has a tail length of about 8 mm to about 16 mm.

[0349] J5. A device of any one of the preceding statements, wherein the tail section has a change in cross-sectional area that changes about 5 percent or less per mm as the tail section extends between the body and the convergence.

[0350] J6. A device of any one of the preceding statements, wherein device comprises two or more tail and / or sleeve stator fin(s).

[0351] J7. A device of any one of the preceding statements, wherein the one or more tail and / or sleeve stator fin(s) have a wrap angle of about 90 to about 270 degrees.

[0352] J8. A device of any one of the preceding statements, wherein the tail section extends greater than 0 percent of the tail length into the outflow end.

[0353] J9. A device of any one of the preceding statements, wherein the tail section has a fullness of about 0.7 to about 1.2.

[0354] J 10. A device of any one of the preceding statements, wherein the tail section has a trailing edge angle of about 30 degrees to about 0 degrees.

[0355] JI 1. A device of any one of the preceding statements, wherein the one or more tail and / or sleeve stator fin(s) have a length measured in the axial direction of the rotor of about 5 mm to about 15 mm.

[0356] J12. A device of any one of the preceding statements, wherein the one or more sleeve stator fin(s) extend along about 10 percent to about 90 percent of the body length.

[0357] JI 3. A device of any one of the preceding statements, wherein the rotor is configured to magnetically rotate relative to the channel by interaction between one or more motor magnet(s) disposed within the rotor and a motor coil located within the housing.

[0358] J14. A device of any one of the preceding statements, wherein the tail section tapers to a tail angle of about 10 degrees to about 20 degrees.

[0359] J15. A device of any one of the preceding statements, wherein the tail section comprises: a. an initial section connected with the body; and b. a convergence section connected with the convergence, wherein a initial angle of the initial section is less than a convergence angle of the convergence section.

[0360] J16. A device of any one of the preceding statements, wherein the initial angle is about 10 degrees to about to about 70 degrees, relative to the rotational axis.

[0361] JI 7. A device of any one of the preceding statements, wherein the convergence angle is about 80 degrees to about 140 degrees, relative to the rotational axis.

[0362] - 59 -

[0363] 4867-4113-8494, v. 1 JI 8. A device of any one of the preceding statements, wherein a pressure of blood is increased as the blood moves from the inflow end through the channel at a location of the sleeve.

[0364] JI 9. A device of any one of the preceding statements, wherein a pressure drop of the blood moving from the impeller section to the tail section 20 percent or less.

[0365] J20. A device, comprising: a. an annular pathway located within a housing and configured to facilitate blood flow; and b. a rotor located within the annular pathway and configured to rotate within an annular pathway of blood flow, comprising: i. a shaft; and ii. one or more bearing magnet(s), one or more motor magnet(s), and one or more actuator magnet(s) disposed on the shaft, wherein some or all of the one or more bearing magnet(s), the one or more motor magnets, and the one or more actuator magnet(s) define one or more lateral space(s) therebetween.

[0366] J21. A device of any one of the preceding statements, wherein the one or more bearing magnet(s), the one or more motor magnet(s), and / or the one or more actuator magnet(s) are configured to align and / or connect with one or more connection feature(s) of the shaft.

[0367] J22. A device of any one of the preceding statements, further comprising: a. one or more spacer(s) are positioned within the one or more lateral space(s) that separate some or all of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).

[0368] J23. A device of any one of the preceding statements, wherein the shaft extends along a rotational axis of the rotor.

[0369] J24. A device of any one of the preceding statements, wherein some or all of the one or more bearing magnet(s) and the one or more actuator magnet(s) are adjacent and aligned to each other along the rotational axis.

[0370] J25. A device of any one of the preceding statements, wherein the one or more motor magnet(s) separate some of the one or more bearing magnet(s) along the shaft.

[0371] J26. A device of any one of the preceding statements, wherein the rotor further comprises: a. a body; b. an impeller section connected with the body; and c. a tail section connected with the body that tapers to a convergence.

[0372] - 60 -

[0373] 4867-4113-8494, v. 1 J27. A device of any one of the preceding statements, wherein the body, the impeller section, and / or the tail section define a gap within the internal surfaces of the rotor so that size tolerance of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s) is improved.

[0374] J28. A device of any one of the preceding statements, wherein the gap is about 0.025 mm to about 0.1 mm.

[0375] J29. A device of any one of the preceding statements, wherein the tail section has a tail length that is longer than a body length of the body along the rotational axis.

[0376] J30. A device of any one of the preceding statements, wherein the impeller section includes an impeller configured to facilitate blood flow within the annular pathway.

[0377] J31. A device of any one of the preceding statements, wherein the rotor further comprises: a. a body that encloses the shaft, the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).

[0378] J32. A device of any one of the preceding statements, wherein the body in part defines the one or more space(s) between the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).

[0379] J33. A device of any one of the preceding statements, wherein each of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s) has a shape of a ring.

[0380] J34. A device of any one of the preceding statements, wherein the one or more motor magnet(s) and / or one or more actuator magnet(s) directly contact the shaft.

[0381] J35. A device of any one of the preceding statements, wherein the impeller section and / or the tail section connect with the shaft through a threaded connection.

[0382] J36. A device, comprising: a. an annular pathway defined within a housing and configured to facilitate blood flow; b. a rotor positioned within the annular pathway and configured to magnetically rotate relative to annular pathway; and c. two or more non-contact position sensor(s) positioned adjacent to the annular pathway and within the housing, wherein each of the two or more non-contact position sensor(s) are configured to monitor a position of the rotor as the rotor rotates.

[0383] J37. A device of any one of the preceding statements, further comprising:

[0384] - 61 -

[0385] 4867-4113-8494, v. 1 a. a housing that encloses the annular pathway, the rotor, and the two or more noncontact position sensor(s).

[0386] J38. A device of any one of the preceding statements, wherein the two or more non-contact position sensor(s) are positioned within the housing and separated from the annular pathway. J39. A device of any one of the preceding statements, wherein the annular pathway comprises: a. a channel; b. an inflow end configured to facilitate blood flow into the channel; and c. an outflow end configured to facilitate blood flow out of the channel.

[0387] J40. A device of any one of the preceding statements, wherein the two or more non-contact position sensor(s) are connected by one or more sensor circuit(s) that are configured to connect with one or more printed circuit board(s).

[0388] J41. A device of any one of the preceding statements, wherein the one or more sensor circuit(s) connect with the one or more printed circuit board(s) through one or more board extension(s) that support the two or more non-contact position sensor(s) around the rotational axis.

[0389] J42. A device of any one of the preceding statements, wherein the device includes three or more non-contact position sensor(s) that are evenly spaced relative to a rotational axis of the rotor.

[0390] J43. A device of any one of the preceding statements, wherein the device includes three or more non-contact position sensor(s) that are circumferentially spaced about 0 degrees to about 120 degrees relative to a rotational axis of the rotor.

[0391] J44. A device of any one of the preceding statements, wherein the two or more non-contact position sensor(s) are configured to identify anomalies during the rotation of the rotor.

[0392] J45. A device, comprising: a. a housing, comprising: i. an annular pathway defined by inner surfaces of the housing, the annular pathway configured to facilitate blood flow; ii. front and rear stator magnet(s) positioned within the housing; iii. two or more voice coil(s) positioned within the housing and separating the front stator magnet and the rear stator magnet; and iv. a motor coil that separates at least two of the two or more voice coil(s); and

[0393] - 62 -

[0394] 4867-4113-8494, v. 1 b. a rotor located within and configured to magnetically rotate relative to the annular pathway, the rotor comprising: i. two or more bearing magnet(s) connected with a shaft and laterally aligned with the front and rear stator magnet(s); ii. two or more actuator magnet(s) connected with a shaft and laterally aligned with opposing of the two or more voice coil(s) and separate at least two of the two or more bearing magnet(s); and iii. a motor magnet that is connected with a shaft, laterally aligned with the motor coil, and separates at least two of the two or more actuator magnet(s).

[0395] J46. A device of any one of the preceding statements, wherein the motor magnet is separated from the two or more actuator magnet(s) by two or more spacer(s).

[0396] J47. A device of any one of the preceding statements, wherein rotor includes an impeller section that is positioned at or adjacent to an inflow end of the annular pathway.

[0397] J48. A device of any one of the preceding statements, wherein the rotor is mass balanced on the rotational axis for improved stability during rotation.

[0398] J49. A device of any one of the preceding statements, wherein a housing assembly of the front stator magnet and rear stator magnet, the two or more voice coil(s), and the motor coil and a rotor assembly of the two or more bearing magnet(s), the two or more actuator magnet(s), and the motor magnet are aligned and / or symmetrical so that pitch / yaw forces acting on the rotor are balanced.

[0399] J50. A device of any one of the preceding statements, wherein the motor magnet is centrally disposed on the shaft.

[0400] J51. A device of any one of the preceding statements, wherein motor magnet is centrally disposed between the nose cone and the tail cone.

[0401] J52. A device of any one of the preceding statements, wherein the motor magnet is configured to rotate the shaft.

[0402] J53. A device of any one of the preceding statements, wherein each of the one or more bearing magnet(s), the one or more motor magnet(s), and the two or more actuator magnet(s) has a shape of a ring.

[0403] J54. A device, comprising: a. a stator housing, comprising:

[0404] - 63 -

[0405] 4867-4113-8494, v. 1 i. a rotor positioned within an annular pathway of the stator housing, the rotor configured to magnetically rotate relative to the annular pathway on a rotational axis and facilitate the flow of blood; and b. a printed circuit board positioned within an electrical housing that is fluidly separated from the stator housing, comprising: i. an axial portion configured to connect with a cable assembly; and ii. a base portion extended from the axial portion and electrically interfaced with the stator housing.

[0406] J55. A device of any one of the preceding statements, wherein the base portion and the axial portion are flexibly connected so that the axial portion and base portion have some rotation relative to each other.

[0407] J56. A device of any one of the preceding statements, wherein the base portion and the axial portion are flexibly connected so that the axial portion and base portion are rotatable to each other without disconnecting the cable assembly from the axial portion. The device of claim 59, wherein the base portion and the axial portion are connected by a flexible portion. J57. A device of any one of the preceding statements, wherein the base portion and the axial portion are essentially perpendicular relative to each other.

[0408] J58. A device of any one of the preceding statements, wherein the base portion includes one or more electrical component(s) disposed on the base portion.

[0409] J59. A device of any one of the preceding statements, wherein the one or more electrical component(s) comprises resistors, capacitors, integrated circuits, transistors, chokes, sensors, other electrical components, or any combination thereof.

[0410] J60. A device of any one of the preceding statements, wherein the cable assembly connects with the axial portion through one or more electrical pin(s) or other electrical connections.

[0411] J61. A device of any one of the preceding statements, further comprising: a. a feedthrough assembly that extends between the stator housing and the electrical housing, wherein the feedthrough assembly comprises one or more feedthrough pin(s) that connect the cable assembly and the axial portion.

[0412] J62. A device of any one of the preceding statements, wherein printed circuit board is connected with the stator housing through one or more fastener(s).

[0413] J63. A device, comprising: a. a housing, comprising: i. a channel;

[0414] - 64 -

[0415] 4867-4113-8494, v. 1 ii. an inflow end comprising barbs that are configured to connect with a hose and configured to facilitate blood flow into the channel; and iii. an outflow end comprising barbs that are configured to connect with a hose and configured to facilitate blood flow out of the channel; b. an inlet hose barb magnetically connected to the housing at the channel and / or the inflow end; and c. an outlet hose barb magnetically connected to the at the channel and / or the outflow end.

[0416] J64. A device of any one of the preceding statements, wherein the inlet hose barb and / or the outlet hose barb each comprise alternating magnet segments of alternating polarity such that when rotated with respect to one another causes coupling and / or uncoupling.

[0417] J65. A device of any one of the preceding statements, further comprising: a. a rotor disposed within the channel, the rotor configured to rotate along a rotational axis and relative to the annular pathway.

[0418] J66. A device of any one of the preceding statements, wherein the inlet hose barb and the outlet hose barb are configured to connect with one or more flexible tubing that circulate blood through the device.

[0419] J67. A device of any one of the preceding statements, wherein the inlet hose barb comprises an inlet barb magnet assembly that is magnetically affixed to an inlet housing magnet assembly or an inlet paramagnetic material within the housing at the inflow end. J68. A device of any one of the preceding statements, wherein the outlet hose barb comprises with an outlet barb magnet assembly that is magnetically affixed to an outlet housing magnet assembly or an outlet paramagnetic material within the housing at the outflow end.

[0420] J69. A device of any one of the preceding statements, wherein the inlet barb magnet assembly and the inlet housing magnet assembly each comprise an annular magnet assembly that have opposite magnetization directions along a rotational axis of the rotor.

[0421] J70. A device of any one of the preceding statements, wherein the outlet barb magnet assembly and the outlet housing magnet assembly each comprise an annular magnet assembly that has opposite magnetization directions along a rotational axis of the rotor.

[0422] J71. A device of any one of the preceding statements, wherein each of the annular magnet assemblies comprises at least two arcuate segments having alternating magnetization directions.

[0423] J72. A device, comprising:

[0424] - 65 -

[0425] 4867-4113-8494, v. 1 a. an annular pathway, comprising: i. a channel defined by inner surfaces of a housing; ii. an inflow end configured to receive blood through an inflow conduit; and iii. an outflow end configured to receive the blood through an outflow conduit; b. at least one stator blade positioned at the channel and / or outflow element; and c. a rotor comprising: i. an impeller section comprising at least one blade that forms a flow path divergence, ii. a tail section that forms a flow path convergence at the at least one stator blade, iii. a body that extends between the tail section and the impeller section; and iv. at least one of:

[0426] 1. an inlet shroud that extends along over a portion of each blade of the impeller section; and / or

[0427] 2. an outlet shroud that extends along a portion of the at least one stator blade.

[0428] J73. A device of any one of the preceding statements, wherein the inlet shroud conforms to the inner surface of the housing.

[0429] J74. A device of any one of the preceding statements, wherein the outlet shroud conforms to the tail section to avoid scratching of tailcone during rotation of the rotor.

[0430] J75. A device of any one of the preceding statements, wherein the outlet shroud is configured to protect the tips of each stator blade from damage due to contact with the outer surface of the rotor.

[0431] J76. A device of any one of the preceding statements, the inlet shroud is configured to protect the tips of each blade of the inflow element from damage due to contact with the inner surface of the pump housing.

[0432] EXAMPLES

[0433] Example 1 :

[0434]

[0138] FIG. 3 is a comparative illustration of performance properties of a blood pump, such as the blood pump of FIG. 1 as compared to comparative example 1. As illustrated, the

[0435] - 66 -

[0436] 4867-4113-8494, v. 1 example 1 including a longer tail section (both top lines) illustrates a large increase in the maintaining and retention of the pressure of the blood pump. The top lines of example 1 also vary the tail stator fin lengths, which shows improved pressure with varying tail stator fin lengths and a longer tail section. Comparative, comparative example 1 with a small tail length shows a drop in pressure upon entering the end of the channel and the outflow end, which demonstrates the effectiveness of a longer tail section.

[0437] Example 2:

[0438]

[0139] FIG. 4B illustrates performance of the blood pump with and without a front diffuser (i.e., sleeve or removable sleeve) and having an elongated tail section (e.g., blood pumps 100, 200, or 400 of FIGS. 1-2B, 4A, and 4C). As illustrated, use of the front diffuser improves pressure at the same RPMs and liters per minute.

[0439] Example 3 :

[0440]

[0140] FIG. 4D is a comparative illustration of performance of the blood pump with the removable sleeve (Example 3), such as the blood pump 400 of FIG. 4A-4B compared to a blood pump without a sleeve (Comparative Example 3), such as the blood pumps 100, 200 of FIGS. 1-2B. Example 3 shows that the presently designed removable sleeve, which includes sleeve stator fin, permits exchange of components (rotor and / or stators) to customize the configuration, hence flow range, for optimal performance in alternative applications, while maintaining / reusing all other components. The customization of the removable sleeve allows for using the blood pump in multiple application settings.

[0441] - 67 -

[0442] 4867-4113-8494, v. 1

Claims

CLAIMSWhat is claimed is:

1. A device, comprising: a. an annular pathway comprising: i. a channel defined within a housing; ii. an inflow end configured to facilitate blood flow into the channel; and iii. an outflow end configured to facilitate blood flow out of the channel; b. a rotor disposed within the channel, the rotor comprising: i. a body; ii. an impeller section connected with the body; and iii. a tail section connected with the body that tapers to a convergence; and c. one or more tail stator fin(s) that overlay the tail section; wherein the device further comprises a removable sleeve disposed within the channel, the removable sleeve comprising one or more sleeve stator fin(s) positioned at the body, the one or more sleeve stator fin(s) configured to increase blood flow within the channel; wherein the tail section extends into both of the outflow end and the channel along a rotational axis; and / or wherein the tail section has a tail length that is longer than an impeller length of the impeller section along the rotational axis.

2. The device of claim 1, wherein the tail section has a tail angle with respect to the rotational axis that is 40 degrees or less.

3. The device of claim 2, wherein the tail section has a tail angle with respect to the rotational axis that is 20 degrees or less.

4. The device of claim 2, wherein tail section has a tail length of about 8 mm to about 16 mm.

5. The device of claim 1, wherein the tail section has a change in cross-sectional area that changes about 5 percent or less per mm as the tail section extends between the body and the convergence.

6. The device of claim 1, wherein device comprises two or more tail and / or sleeve stator fin(s).

7. The device of claim 1, wherein the one or more tail and / or sleeve stator fin(s) have a wrap angle of about 90 to about 270 degrees.- 68 -4867-4113-8494, v.

18. The device of claim 1, wherein the tail section extends greater than 0 percent of the tail length into the outflow end.

9. The device of claim 1, wherein the tail section has a fullness of about 0.7 to about 1.2.

10. The device of claim 1, wherein the tail section has a trailing edge angle of about 30 degrees to about 0 degrees.

11. The device of claim 1, wherein the one or more tail and / or sleeve stator fin(s) have a length measured in the axial direction of the rotor of about 5 mm to about 15 mm.

12. The device of claim 1, wherein the one or more sleeve stator fin(s) extend along about 10 percent to about 90 percent of the body length.

13. The device of claim 1, wherein the rotor is configured to magnetically rotate relative to the channel by interaction between one or more motor magnet(s) disposed within the rotor and a motor coil located within the housing.

14. The device of claim 1, wherein the tail section tapers to a tail angle of about 10 degrees to about 20 degrees.

15. The device of claim 1, wherein the tail section comprises: a. an initial section connected with the body; and b. a convergence section connected with the convergence, wherein a initial angle of the initial section is less than a convergence angle of the convergence section.

16. The device of claim 1, wherein the initial angle is about 10 degrees to about to about 70 degrees, relative to the rotational axis.

17. The device of claim 1, wherein the convergence angle is about 80 degrees to about 140 degrees, relative to the rotational axis.

18. The device of claim 1, wherein a pressure of blood is increased as the blood moves from the inflow end through the channel at a location of the sleeve.

19. The device of claim 18, wherein a pressure drop of the blood moving from the impeller section to the tail section 20 percent or less.

20. A device, comprising: a. an annular pathway located within a housing and configured to facilitate blood flow; and b. a rotor located within the annular pathway and configured to rotate within an annular pathway of blood flow, comprising: i. a shaft; and- 69 -4867-4113-8494, v. 1ii. one or more bearing magnet(s), one or more motor magnet(s), and one or more actuator magnet(s) disposed on the shaft, wherein some or all of the one or more bearing magnet(s), the one or more motor magnets, and the one or more actuator magnet(s) define one or more lateral space(s) therebetween.

21. The device of claim 20, wherein the one or more bearing magnet(s), the one or more motor magnet(s), and / or the one or more actuator magnet(s) are configured to align and / or connect with one or more connection feature(s) of the shaft.

22. The device of claim 20, further comprising: a. one or more spacer(s) are positioned within the one or more lateral space(s) that separate some or all of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).

23. The device of claim 20, wherein the shaft extends along a rotational axis of the rotor.

24. The device of claim 20, wherein some or all of the one or more bearing magnet(s) and the one or more actuator magnet(s) are adjacent and aligned to each other along the rotational axis.

25. The device of claim 20, wherein the one or more motor magnet(s) separate some of the one or more bearing magnet(s) along the shaft.

26. The device of claim 20, wherein the rotor further comprises: a. a body; b. an impeller section connected with the body; and c. a tail section connected with the body that tapers to a convergence.

27. The device of claim 26, wherein the body, the impeller section, and / or the tail section define a gap within the internal surfaces of the rotor so that size tolerance of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s) is improved.

28. The device of claim 27, wherein the gap is about 0.025 mm to about 0.1 mm.

29. The device of claim 26, wherein the tail section has a tail length that is longer than a body length of the body along the rotational axis.

30. The device of claim 29, wherein the impeller section includes an impeller configured to facilitate blood flow within the annular pathway.

31. The device of claim 20, wherein the rotor further comprises: a. a body that encloses the shaft, the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).- 70 -4867-4113-8494, v.

132. The device of claim 31, wherein the body in part defines the one or more space(s) between the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s).

33. The device of claim 20, wherein each of the one or more bearing magnet(s), the one or more motor magnet(s), and the one or more actuator magnet(s) has a shape of a ring.

34. The device of claim 20, wherein the one or more motor magnet(s) and / or one or more actuator magnet(s) directly contact the shaft.

35. The device of claim 26, wherein the impeller section and / or the tail section connect with the shaft through a threaded connection.

36. A device, comprising: a. an annular pathway defined within a housing and configured to facilitate blood flow; b. a rotor positioned within the annular pathway and configured to magnetically rotate relative to annular pathway; and c. two or more non-contact position sensor(s) positioned adjacent to the annular pathway and within the housing, wherein each of the two or more non-contact position sensor(s) are configured to monitor a position of the rotor as the rotor rotates.

37. The device of claim 36, further comprising: a. a housing that encloses the annular pathway, the rotor, and the two or more non-contact position sensor(s).

38. The device of claim 36, wherein the two or more non-contact position sensor(s) are positioned within the housing and separated from the annular pathway.

39. The device of claim 36, wherein the annular pathway comprises: a. a channel; b. an inflow end configured to facilitate blood flow into the channel; and c. an outflow end configured to facilitate blood flow out of the channel.

40. The device of claim 36, wherein the two or more non-contact position sensor(s) are connected by one or more sensor circuit(s) that are configured to connect with one or more printed circuit board(s).

41. The device of claim 40, wherein the one or more sensor circuit(s) connect with the one or more printed circuit board(s) through one or more board extension(s) that support the two or more non-contact position sensor(s) around the rotational axis.- 71 -4867-4113-8494, v.

142. The device of claim 36, wherein the device includes three or more non-contact position sensor(s) that are evenly spaced relative to a rotational axis of the rotor.

43. The device of claim 36, wherein the device includes three or more non-contact position sensor(s) that are circumferentially spaced about 0 degrees to about 120 degrees relative to a rotational axis of the rotor.

44. The device of claim 36, wherein the two or more non-contact position sensor(s) are configured to identify anomalies during the rotation of the rotor.

45. A device, comprising: a. a housing, comprising: i. an annular pathway defined by inner surfaces of the housing, the annular pathway configured to facilitate blood flow; ii. front and rear stator magnet(s) positioned within the housing; iii. two or more voice coil(s) positioned within the housing and separating the front stator magnet and the rear stator magnet; and iv. a motor coil that separates at least two of the two or more voice coil(s); and b. a rotor located within and configured to magnetically rotate relative to the annular pathway, the rotor comprising: i. two or more bearing magnet(s) connected with a shaft and laterally aligned with the front and rear stator magnet(s); ii. two or more actuator magnet(s) connected with a shaft and laterally aligned with opposing of the two or more voice coil(s) and separate at least two of the two or more bearing magnet(s); and iii. a motor magnet that is connected with a shaft, laterally aligned with the motor coil, and separates at least two of the two or more actuator magnet(s).

46. The device of claim 45, wherein the motor magnet is separated from the two or more actuator magnet(s) by two or more spacer(s).

47. The device of claim 45, wherein rotor includes an impeller section that is positioned at or adjacent to an inflow end of the annular pathway.

48. The device of claim 45, wherein the rotor is mass balanced on the rotational axis for improved stability during rotation.

49. The device of claim 45, wherein a housing assembly of the front stator magnet and rear stator magnet, the two or more voice coil(s), and the motor coil and a rotor- 72 -4867-4113-8494, v. 1assembly of the two or more bearing magnet(s), the two or more actuator magnet(s), and the motor magnet are aligned and / or symmetrical so that pitch / yaw forces acting on the rotor are balanced.

50. The device of claim 45, wherein the motor magnet is centrally disposed on the shaft.

51. The device of claim 45, wherein motor magnet is centrally disposed between the nose cone and the tail cone.

52. The device of claim 45, wherein the motor magnet is configured to rotate the rotor.

53. The device of claim 45, wherein each of the one or more bearing magnet(s), the one or more motor magnet(s), and the two or more actuator magnet(s) has a shape of a ring.

54. A device, comprising: a. a stator housing, comprising: i. a rotor positioned within an annular pathway of the stator housing, the rotor configured to magnetically rotate relative to the annular pathway on a rotational axis and facilitate the flow of blood; and b. a printed circuit board positioned within an electrical housing that is fluidly separated from the stator housing, comprising: i. an axial portion configured to connect with a cable assembly; and ii. a base portion extended from the axial portion and electrically interfaced with the stator housing.

55. The device of claim 54, wherein the base portion and the axial portion are flexibly connected so that the axial portion and base portion have some rotation relative to each other.

56. The device of claim 54, wherein the base portion and the axial portion are flexibly connected so that the axial portion and base portion are rotatable to each other without disconnecting the cable assembly from the axial portion. The device of claim 59, wherein the base portion and the axial portion are connected by a flexible portion.

57. The device of claim 54, wherein the base portion and the axial portion are essentially perpendicular relative to each other.

58. The device of claim 54, wherein the base portion includes one or more electrical component(s) disposed on the base portion.

59. The device of claim 58, wherein the one or more electrical component s) comprises resistors, capacitors, integrated circuits, transistors, chokes, sensors, other electrical components, or any combination thereof.- 73 -4867-4113-8494, v.

160. The device of claim 54, wherein the cable assembly connects with the axial portion through one or more electrical pin(s) or other electrical connections.

61. The device of claim 54, further comprising: a. a feedthrough assembly that extends between the stator housing and the electrical housing, wherein the feedthrough assembly comprises one or more feedthrough pin(s) that connect the cable assembly and the axial portion.

62. The device of claim 61, wherein printed circuit board is connected with the stator housing through one or more fastener(s).

63. A device, comprising: a. a housing, comprising: i. a channel; ii. an inflow end comprising barbs that are configured to connect with a hose and configured to facilitate blood flow into the channel; and iii. an outflow end comprising barbs that are configured to connect with a hose and configured to facilitate blood flow out of the channel; b. an inlet hose barb magnetically connected to the housing at the channel and / or the inflow end; and c. an outlet hose barb magnetically connected to the at the channel and / or the outflow end.

64. The device of claim 63, wherein the inlet hose barb and / or the outlet hose barb each comprise alternating magnet segments of alternating polarity such that when rotated with respect to one another causes coupling and / or uncoupling.

65. The device of claim 63, further comprising: a. a rotor disposed within the channel, the rotor configured to rotate along a rotational axis and relative to the annular pathway.

66. The device of claim 63, wherein the inlet hose barb and the outlet hose barb are configured to connect with one or more flexible tubing that circulate blood through the device.

67. The device of claim 63, wherein the inlet hose barb comprises an inlet barb magnet assembly that is magnetically affixed to an inlet housing magnet assembly or an inlet paramagnetic material within the housing at the inflow end.

68. The device of claim 63, wherein the outlet hose barb comprises with an outlet barb magnet assembly that is magnetically affixed to an outlet housing magnet assembly or an outlet paramagnetic material within the housing at the outflow end.- 74 -4867-4113-8494, v.

169. The device of claim 63, wherein the inlet barb magnet assembly and the inlet housing magnet assembly each comprise an annular magnet assembly that have opposite magnetization directions along a rotational axis of the rotor.

70. The device of claim 69, wherein the outlet barb magnet assembly and the outlet housing magnet assembly each comprise an annular magnet assembly that has opposite magnetization directions along a rotational axis of the rotor.

71. The device of claim 70, wherein each of the annular magnet assemblies comprises at least two arcuate segments having alternating magnetization directions.

72. A device, comprising: a. an annular pathway, comprising: i. a channel defined by inner surfaces of a housing; ii. an inflow end configured to receive blood through an inflow conduit; and iii. an outflow end configured to receive the blood through an outflow conduit; b. at least one stator blade positioned at the channel and / or outflow element; and c. a rotor comprising: i. an impeller section comprising at least one blade that forms a flow path divergence, ii. a tail section that forms a flow path convergence at the at least one stator blade, iii. a body that extends between the tail section and the impeller section; and iv. at least one of:

1. an inlet shroud that extends along over a portion of each blade of the impeller section; and / or2. an outlet shroud that extends along a portion of the at least one stator blade.

73. The device of claim 72, wherein the inlet shroud conforms to the inner surface of the housing.

74. The device of claim 72, wherein the outlet shroud conforms to the tail section to avoid scratching of tailcone during rotation of the rotor.

75. The device of claim 72, wherein the outlet shroud is configured to protect the tips of each stator blade from damage due to contact with the outer surface of the rotor.- 75 -4867-4113-8494, v.

176. The device of claim 72, the inlet shroud is configured to protect the tips of each blade of the inflow element from damage due to contact with the inner surface of the pump housing.- 76 -4867-4113-8494, v. 1

Images