Magnetic impeller and bearing for a hemodynamic support pump

Abstract

Various aspects of the present disclosure relate to apparatuses, systems, and methods that can include a blood pump. The blood pump can include a magnetic field source and an impeller assembly. The impeller assembly includes an impeller and a driven magnet. The driven magnet is longitudinally offset and distally disposed relative to the magnetic field source, and the driven magnet is rotatable by and longitudinally controlled by the magnetic field source. The driven magnet includes a distal side that faces the impeller. The blood pump further includes a bearing assembly proximate the distal side of the driven magnet.

Description

[0001] Cross-references to related applications

[0002] This patent application claims priority to provisional application No. 63 / 147,998, filed on February 10, 2021, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This disclosure relates to transdermal circulation support devices. More specifically, this disclosure relates to bearing assemblies and magnetic drive systems for use in transdermal circulation support devices. Background Technology

[0004] Transcutaneous circulatory support devices, such as blood pumps, can provide short-term support for hours or months to patients with impaired cardiac function or cardiac output. Magnetic-driven pumps offer improvements over existing technologies because they provide easier treatment management, easier patient mobility, and improved device durability. Wear at bearing surfaces can limit device lifespan, and mechanical interaction with blood at bearing surfaces can lead to hemolysis or other health complications. Contact between blood and magnetic surfaces can also cause corrosion of components. Furthermore, blood pump performance and blood flow rate can be affected by component imbalances and insufficient generation and transmission of magnetic torque between device components. Summary of the Invention

[0005] In Example 1, the blood pump includes a magnetic field source, an impeller assembly, and a bearing assembly; the impeller assembly includes a longitudinal axis, an impeller, and a driven magnet that is longitudinally biased and disposed distally relative to the magnetic field source, the driven magnet being rotatable and longitudinally controlled by the magnetic field source, and the driven magnet including a distal side facing the impeller; the bearing assembly is located near the distal side of the driven magnet.

[0006] In Example 2, the blood pump according to Example 1 further includes an impeller assembly housing, a bearing assembly contacting the impeller assembly housing, and the impeller assembly housing rotatably carrying the impeller assembly via the bearing assembly.

[0007] In Example 3, the blood pump according to Example 2, wherein the impeller assembly housing includes a recess that receives a bearing assembly.

[0008] In Example 4, the blood pump according to any one of Examples 1 to 3, wherein the distance between the magnetic field source and the driven magnet is less than 0.030 inches.

[0009] In Example 5, the blood pump according to any one of Examples 1 to 4, wherein the impeller assembly has a center of mass and the bearing assembly is longitudinally aligned with the center of mass of the impeller assembly.

[0010] In Example 6, the blood pump according to any one of Examples 1 to 5, wherein any part of the bearing assembly is not located between the driven magnet and the magnetic field source.

[0011] In Example 7, the blood pump according to any one of Examples 2 to 6, wherein the impeller assembly housing does not house the bearing assembly located at the distal end of the impeller.

[0012] In Example 8, the blood pump according to any one of Examples 1 to 7, wherein the impeller assembly is rotatable about a longitudinal axis, and the bearing assembly is arranged radially outward relative to the longitudinal axis.

[0013] In Example 9, the blood pump according to any one of Examples 2 to 8, wherein the impeller assembly further includes a shaft, and a bearing assembly contacts the shaft and the impeller assembly housing.

[0014] In Example 10, the blood pump according to any one of Examples 2 to 9, wherein the bearing assembly includes: a first bearing and a second bearing, the first bearing contacting the shaft and the impeller assembly housing, and the second bearing contacting the first bearing and the impeller.

[0015] In Example 11, the blood pump includes: a magnetic field source, an impeller assembly, and a bearing assembly; the impeller assembly includes a longitudinal axis, an impeller, and a driven magnet that is longitudinally biased and disposed distally relative to the magnetic field source, the driven magnet being rotatable by and longitudinally controlled by the magnetic field source; the bearing assembly is coupled to the impeller assembly, wherein no part of the bearing assembly is located between the driven magnet and the magnetic field source.

[0016] In Example 12, the blood pump according to Example 11 further includes an impeller assembly housing, a bearing assembly contacting the impeller assembly housing, and the impeller assembly housing rotatably carrying the impeller assembly via the bearing assembly.

[0017] In Example 13, the blood pump according to Example 12 includes an impeller assembly housing with a recess that receives a bearing assembly.

[0018] In Example 14, the blood pump according to any one of Examples 12 to 13, wherein the bearing assembly includes: a first bearing and a second bearing, the first bearing contacting the shaft and the impeller assembly housing, and the second bearing contacting the first bearing and the impeller.

[0019] In Example 15, the blood pump according to any one of Examples 11 to 14, wherein the bearing assembly includes a magnetic bearing that encapsulates a driven magnet.

[0020] In Example 16, the blood pump includes an impeller assembly housing, a magnetic field source, an impeller assembly, and a bearing assembly; the magnetic field source is coupled to the impeller assembly housing; the impeller assembly is located within the impeller assembly housing and includes a longitudinal axis, an impeller, and a driven magnet, which is longitudinally biased and disposed distally relative to the magnetic field source, the driven magnet being rotatable and longitudinally controlled by the magnetic field source, and the driven magnet including a distal side facing the impeller; the bearing assembly is located within and in contact with the impeller assembly housing and is located near the distal side of the driven magnet.

[0021] In Example 17, the blood pump according to Example 16 includes an impeller assembly housing with a recess that receives a bearing assembly.

[0022] In Example 18, the blood pump according to Example 16 is used, wherein the distance between the magnetic field source and the driven magnet is less than 0.030 inches.

[0023] In Example 19, the blood pump according to Example 16 is provided, wherein the impeller assembly has a center of mass, and the bearing assembly is longitudinally aligned with the center of mass of the impeller assembly.

[0024] In Example 20, the blood pump according to Example 16 is provided, wherein no part of the bearing assembly is located between the driven magnet and the magnetic field source.

[0025] In Example 21, the blood pump according to Example 16 is provided, wherein the impeller assembly housing does not house the bearing assembly located at the distal end of the impeller.

[0026] In Example 22, the blood pump according to Example 16 is provided, wherein the impeller assembly is rotatable about a longitudinal axis, and the bearing assembly is arranged radially outward relative to the longitudinal axis.

[0027] In Example 23, the blood pump according to Example 16 further includes a shaft in which a bearing assembly contacts the shaft and the impeller assembly housing.

[0028] In Example 24, the blood pump according to Example 23 includes a bearing assembly comprising a first bearing and a second bearing, the first bearing contacting the shaft and the impeller assembly housing, and the second bearing contacting the first bearing and the impeller.

[0029] In Example 25, the blood pump according to Example 23 has its shaft connected to and rotatable with the impeller.

[0030] In Example 26, the blood pump includes an impeller assembly housing, a magnetic field source, an impeller assembly, and a bearing assembly; the magnetic field source is coupled to the impeller assembly housing; the impeller assembly is located within the impeller assembly housing and includes a longitudinal axis, an impeller, and a driven magnet, which is longitudinally biased and disposed distally relative to the magnetic field source, and is rotatable by the magnetic field source; the bearing assembly is located within and in contact with the impeller assembly housing and is coupled to the impeller assembly, wherein no part of the bearing assembly is located between the driven magnet and the magnetic field source.

[0031] In Example 27, the blood pump according to Example 26 further includes a shaft in the impeller assembly.

[0032] In Example 28, the blood pump according to Example 27 is wherein the bearing assembly contacts the shaft and the impeller assembly housing.

[0033] In Example 29, the blood pump according to Example 27 has its shaft connected to and rotatable with the impeller.

[0034] In Example 30, the blood pump according to Example 26, wherein the impeller assembly housing includes a recess that receives a bearing assembly.

[0035] In Example 31, the blood pump according to Example 26 includes a bearing assembly comprising a magnetic bearing that encapsulates a driven magnet.

[0036] In Example 32, the blood pump according to Example 26, wherein the impeller assembly housing does not house the bearing assembly located at the distal end of the impeller.

[0037] In Example 33, the method of assembling a blood pump includes: connecting an impeller assembly to a bearing assembly such that the bearing assembly is located near the distal side of a driven magnet and the distal side of the driven magnet faces the impeller of the impeller assembly; connecting the bearing assembly to an impeller assembly housing such that the bearing assembly contacts the impeller assembly housing and the driven magnet is longitudinally biased and positioned distally relative to a magnetic field source.

[0038] In Example 34, according to the method of Example 33, connecting the impeller assembly to the bearing assembly includes contacting the shaft of the impeller assembly with the bearing assembly.

[0039] In Example 35, according to the method of Example 33, connecting the bearing assembly to the impeller assembly housing includes positioning the bearing assembly in a recess of the impeller assembly housing.

[0040] While several embodiments have been disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which illustrates and describes exemplary embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative and non-limiting. Attached Figure Description

[0041] Figure 1A A cross-sectional side view of a portion of an exemplary percutaneous mechanical circulatory support device (also interchangeably referred to herein as a “blood pump”) is shown according to embodiments of the subject matter disclosed herein.

[0042] Figure 1B A cross-sectional view of an embodiment of an exemplary transdermal mechanical circulation support device is shown according to embodiments of the subject matter disclosed herein;

[0043] Figure 1C Embodiments of the subject matter disclosed herein are shown Figure 1A A perspective view of a portion of an exemplary transdermal mechanical circulation support device;

[0044] Figure 1D A side view of a portion of an embodiment of an exemplary transdermal mechanical circulation support device is shown according to embodiments of the subject matter disclosed herein;

[0045] Figure 2A A cross-sectional side view of a cyclic support device is shown according to an embodiment of the subject matter disclosed herein;

[0046] Figure 2B Embodiments of the subject matter disclosed herein are shown Figure 2A A perspective view of a portion of the exemplary transdermal mechanical circulation support device shown;

[0047] Figure 3A A perspective view of an embodiment of a bearing assembly is shown based on the subject matter disclosed herein;

[0048] Figure 3B Embodiments of the subject matter disclosed herein are shown Figure 3A A sectional side view of the bearing assembly shown.

[0049] Figure 4 A cross-sectional view of another embodiment of the exemplary transdermal mechanical circulation support device is shown according to the embodiments of the subject matter disclosed herein;

[0050] Figure 5 A cross-sectional view of yet another embodiment of the exemplary transdermal mechanical circulation support device is shown based on the embodiments of the subject matter disclosed herein.

[0051] While the disclosed subject matter may be modified in various ways and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and described in detail below. However, it is not intended to limit the subject matter disclosed herein to the specific embodiments described. Rather, this disclosure is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the subject matter disclosed herein, and as defined in the appended claims.

[0052] As used herein with respect to numerical values ​​(e.g., terms of amplitude, measurement, and / or other degrees of qualitative and / or quantitative observations used herein relative to tangible things (e.g., products, inventory, etc.) and / or intangible things (e.g., data, electronic representations of currency, accounts, information, parts of things (e.g., percentages, fractions), calculations, data models, dynamic system models, algorithms, parameters, etc.) and / or their ranges), “about” and “approximately” are used interchangeably to refer to numerical values, configurations, orientations, and / or other characteristics that are equal to or identical to the stated numerical values, configurations, orientations, and / or other characteristics, or that are reasonably close to the stated numerical values, configurations, orientations, and / or other characteristics. Position, orientation, and / or other characteristics (or similar); however, there may be reasonably minor differences, such as those that a person skilled in the art would understand and readily determine as attributable to measurement error; differences in the calibration of measuring and / or manufacturing equipment; human error in reading and / or setting measurements; adjustments made to optimize performance and / or structural parameters based on other measurements (e.g., measurements associated with other things); specific implementation conditions; imprecise adjustments or manipulations of things, settings, and / or measurements by people, computing devices, and / or machines; system tolerances; control loops; machine learning; predictable variations (e.g., statistically insignificant variations, chaotic variations, system and / or model instability, etc.); preferences, etc. Detailed Implementation

[0053] Embodiments of the subject matter disclosed herein include blood pump and bearing designs that facilitate a reduction in the number of bearing surfaces and the number or size of magnets incorporated into the transcutaneous circulation support device. The reduction in the number of bearing surfaces within the blood pump offers numerous advantages, including a reduced likelihood of hemolysis and other health complications. Embodiments of the subject matter disclosed herein include blood pump and bearing designs that improve magnetic torque transmission, which can be used to increase blood flow rate, reduce the risk of magnet corrosion, and improve the durability of the blood pump. Furthermore, the embodiments disclosed herein provide improved stability and efficiency of the blood pump components for improved therapeutic outcomes.

[0054] Figure 1A A cross-sectional side view of a portion of an exemplary percutaneous mechanical circulatory support device 100 (also interchangeably referred to herein as a "blood pump") is shown according to embodiments of the subject matter disclosed herein. The blood pump 100 includes a magnetically driven housing 104 that houses a magnetic field source 101. The magnetic field source 101 is configured to generate a varying magnetic field to drive rotation of an impeller 114 to provide blood flow through the blood pump 100. Figure 1AIn the illustrated embodiment, the magnetic field source 101 includes a permanent drive magnet 118 rotating on a motor 102 and configured to cause rotation of a permanent driven magnet 116 coupled to an impeller 114 to provide flow of blood through the blood pump 100. In an alternative embodiment, the drive magnet 118 may be replaced by any type of magnetic rotor. For example, such as Figure 1B As shown and described below, the magnetic field source may include a set of electromagnetic coils configured to cause rotation of a permanently driven magnet coupled to an impeller to provide flow of blood through the blood pump 100. In other alternative embodiments, the magnetic field source may include a stator and a motor for generating the magnetic field.

[0055] A controller (not shown) is operatively coupled to and configured to control motor 102. In one embodiment, the controller may be disposed within a magnetic drive housing 104; or in other embodiments, it may be disposed outside the magnetic drive housing 104 (e.g., in a conduit shank, a separate housing, etc.). In one embodiment, the controller may include multiple components, one or more of which may be disposed within the magnetic drive housing 104. According to an embodiment, the controller may be, may include, or may be comprised of one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. Although the controller is mentioned in a single instance herein, a single controller may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc.

[0056] like Figure 1A As shown, impeller assembly 106 is disposed within impeller assembly housing 108, which includes an inlet orifice (not shown) and a plurality of outlet orifices 107 defined therein. A longitudinal axis 142 extends through impeller assembly 106. According to an embodiment, magnetic drive housing 104 and impeller assembly housing 108 may be integrated together. In other embodiments, magnetic drive housing 104 and impeller assembly housing 108 may be separate components configured to be removably or permanently coupled together.

[0057] exist Figure 1A In the impeller assembly 106, there is an impeller 114 and a driven magnet 116 connected to the impeller 114. The driven magnet 116 has a proximal side 120 and a distal side 122. The driven magnet 116 can be connected to the impeller 114 distally, such as... Figure 1AAs shown. The driven magnet 116 and impeller 114 can be coupled in various ways, including using adhesives, mechanical connections, or interference fits. The driven magnet 116 can be any type of magnetic rotor, which can be driven by the drive magnet 118. As a magnetic field is applied to the driven magnet 116 through the drive magnet 118, the driven magnet 116 rotates, thereby causing the impeller assembly 106 to rotate. The rotation of the impeller 114 causes blood to flow through the blood pump 100.

[0058] like Figure 1A As shown, the driven magnet 116 and the impeller 114 can be connected via a drive shaft 112, which is connected to the impeller 114 and configured to rotate together with the impeller 114. The driven magnet 116 can be connected to the drive shaft 112 and the impeller 114 in various ways, including by adhesive, mechanical connection, or interference fit. The drive shaft 112 may be at least partially disposed within the impeller 114. The drive shaft 112 may also be at least partially surrounded by the driven magnet 116. The drive shaft 112 can be made of any number of different rigid materials, such as, for example, steel, titanium alloy, cobalt-chromium alloy, nickel-titanium, high-strength ceramic, etc.

[0059] Figure 1B An alternative embodiment of the magnetic field source 101 is shown, which includes a stator electromagnetic drive coil assembly 136 electrically coupled to a power source (not shown). In such embodiments, the drive coil assembly 136 may be axially aligned or circumferentially surrounding a driven magnet 116 and configured to drive the driven magnet 116. The drive coil assembly 136 includes a ferromagnetic core 138 and a plurality of coil windings 140. The electromagnetic field may be generated by copper, graphene, or other high-conductivity materials in a coiled configuration. The drive coil assembly 136 may include any number of coil windings 140 arranged in any number configuration within a magnetic drive housing 104. As shown, the drive coil assembly 136 is disposed within the magnetic drive housing 104 and may be axially aligned or circumferentially surrounding the driven magnet 116. In the illustrated embodiment, the magnetic drive housing 104 and the impeller assembly housing 108 are integrated and house the magnetic field source 101 and the impeller assembly 106, which includes a driven magnet 116.

[0060] like Figure 1A As shown, the impeller assembly 106 (including the driven magnet 116) is held within the impeller assembly housing 108 by a bearing assembly 124. According to an embodiment, the bearing assembly 124 may be located near the distal side 122 of the driven magnet 116. Figure 1C This is a perspective view of the driven magnet 116, the magnet bearing 126, and the impeller 114 according to embodiments of the subject matter disclosed herein.

[0061] This document describes various embodiments of bearing assemblies used in blood pumps. For example, such as... Figure 1A As shown, bearing assembly 124 may include magnet bearing 126 and housing bearing 128. According to embodiments, bearing assembly 124 may include different types of bearings. Bearing assembly 124 may also include a lubrication portion, while in other embodiments, bearing assembly 124 may not include a lubrication portion. As shown, bearing assembly 124 has a proximal side 130 that contacts the distal shoulder 110 of driven magnet 116. As shown, housing bearing 128 includes a proximal inner lip 129 that contacts magnet bearing 126. Proximal inner lip 129 bears thrust loads and prevents driven magnet 116 from bottoming out against the proximal end of impeller assembly housing 108.

[0062] like Figure 1A As shown, bearing assembly 124 (including magnet bearing 126 and housing bearing 128) is positioned longitudinally near the center of mass of impeller assembly 106. Mounting magnet bearing 126 near the distal side 122 of driven magnet 116 allows bearing assembly 124 to be positioned close to the center of mass of impeller assembly 106. Bearing assembly 124 is optimized when magnet bearing 126 and housing bearing 128 are aligned with the center of mass of impeller assembly 106. Longitudinally positioning bearing assembly 124 near the center of mass of impeller assembly 106 increases radial control of impeller assembly 106 and prevents eccentric movement of impeller 114 compared to bearing assembly 114, which is positioned adjacent to and away from impeller assembly 106. The position of bearing assembly 124 may be offset from the center of mass of impeller assembly 106 by approximately 0.050 inches based on practical considerations of the component assembly, but is optimized when longitudinally positioned as close as possible to the center of mass of impeller assembly 106. The bearing assembly 124 is also configured to counteract the magnetic coupling axial force using a force parallel to the longitudinal axis of the impeller assembly 106 and to prevent the driven magnet 116 from touching the bottom against the proximal end 134 of the impeller assembly housing 108, thereby providing axial control of the impeller assembly 106.

[0063] The center of mass of impeller assembly 106 depends on both the design and material selection of driven magnet 116, impeller 114, and drive shaft 112, as well as any other materials used to assemble the components together. Suitable magnetic materials that can be used for driven magnet 116 (including neodymium iron boron and samarium cobalt) have a density five to six times greater than that of polymers (such as polyether ether ketone (PEEK)) used in impeller 114. Therefore, driven magnet 116 may account for more than fifty percent of the total mass of impeller assembly 106. Driven magnet 116 may have a reduced diameter portion (such as distal shoulder 110) to facilitate the fixation of magnet bearing 126 to driven magnet 116.

[0064] like Figure 1AAs shown, cavity 132 is formed by the proximal side 130 of bearing assembly 124, impeller assembly housing 108, and driven magnet 116. In embodiments, the size of driven magnet 116 may be reduced to increase the distance between driven magnet 116 and impeller assembly housing 108. Consequently, the size of cavity 132 may be increased. The increased size of cavity 132 reduces the shear stress acting on the blood within cavity 132. Lower shear stress is associated with lower hemolysis and lower platelet activation, which can lead to a lower thrombosis rate. In some embodiments, liquid may be disposed within cavity 132. Liquid may be any type of hydrophobic lubricant suitable for blood pumps. For example, in embodiments, but not intended to limit this disclosure, liquid may be a biocompatible oil or a modified siloxane lubricant, such as, for example, modified polydimethylsiloxane (PDMS). In other embodiments, liquid may be an oil-based lubricant, synthetic oil, carbon-based lubricant, etc. The advantages of using liquid in cavity 132 include reducing the likelihood of air embolism, limiting blood exposure to driven magnet 116 to reduce hemolysis associated with driven magnet 116, reducing the risk of thrombus formation and corrosion on driven magnets through lower blood contact, and reducing hemolysis associated with bearing assembly 124 through lubrication of bearings 126, 128. In other embodiments, cavity 132 may be left empty. In other embodiments, and as... Figure 1D As shown, cavity 132 can be exposed to blood flow to facilitate constant blood circulation around driven magnet 116, which can help prevent thrombosis.

[0065] Figure 1A and Figure 1B The illustrated blood pump can be assembled as follows. Bearing assembly 124 can be assembled by separately mounting magnet bearing 126 and housing bearing 128. Housing bearing 128 can be secured to impeller assembly housing 108 by press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art. On the outside of impeller assembly housing 108, impeller assembly 106 (including driven magnet 116) can be coupled to magnet bearing 126, wherein magnet bearing 126 is secured to driven magnet 116 by press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art. Impeller assembly 106 (including driven magnet 116) and coupled magnet bearing 126 can be collectively referred to as impeller-magnet-bearing assembly 144. Impeller-magnet-bearing assembly 144 can then be positioned within impeller assembly housing 108 such that magnet bearing 126 mates with housing bearing 128. In one embodiment, the outer diameter of the driven magnet 116 may be uniform and smaller in diameter than the combined inner diameter of the impeller assembly housing 108 and the housing bearing 128, such that the impeller-magnet-bearing assembly 144 is fitted within the combination of the housing bearing 128 and the impeller assembly housing 108. In other embodiments, and as... Figure 1A and Figure 1B As shown, the outer diameter of the driven magnet 116 may be substantially the same as the outer diameter of the combination of the driven magnet 116 and the magnet bearing 126, except where the magnet bearing 126 is fixed to the driven magnet 116. For example, in such embodiments, the driven magnet 116 may include a reduced diameter portion (such as a distal shoulder 110) to accommodate the magnet bearing 126. The distal shoulder 110 may facilitate the fixation of the bearing assembly 124, thereby providing improved radial control of the impeller assembly 106.

[0066] Figures 1A to 1D The illustrative loop support device 100 shown is not intended to represent any limitation on the scope and functionality of the embodiments of this disclosure. Nor should the illustrative loop support device 100 be construed as having any dependency or requirement relating to any individual component or combination of components shown herein. Furthermore, in the embodiments, Figures 1A to 1D The various components shown may be integrated with other components shown herein (and / or components not shown), all of which are considered to be within the scope of this disclosure.

[0067] Figure 2A A cross-sectional side view of an exemplary percutaneous mechanical circulatory support device 200 (also interchangeably referred to herein as a "blood pump") is shown according to embodiments of the subject matter disclosed herein; and Figure 2B Embodiments of the subject matter disclosed herein are shown Figure 2A A perspective view of the blood pump 200 is shown. According to an embodiment, the blood pump 200 and / or any number of its various components may be identical or similar to... Figure 1A and Figure 1B The corresponding component of the circulating support device 100 shown.

[0068] like Figure 2A As shown, the blood pump 200 includes a magnetic drive housing 204, which includes a magnetic field source 201 configured to generate a changing magnetic field to drive the rotation of an impeller 216 to provide blood flow through the blood pump 200. Figure 2A In the illustrated embodiment, the magnetic field source 201 includes a permanent drive magnet 220 rotating on a motor 202 and configured to cause rotation of a permanent driven magnet 218 coupled to an impeller 216 to provide blood flow through the blood pump 200. As shown, the driven magnet 218 includes a proximal side 222 and a distal side 224. In an alternative embodiment, as described above but not shown herein, the magnetic field source 201 may include a set of electromagnetic coils or a stator and motor for generating a magnetic field to cause rotation of the permanent driven magnet coupled to the impeller to provide blood flow through the blood pump.

[0069] A controller (not shown) is operatively coupled to and configured to control the motor 202. In one embodiment, the controller may be disposed within the magnetic drive housing 204; or in other embodiments, it may be disposed outside the magnetic drive housing 204 (e.g., in a catheter stem, a separate housing, etc.). In one embodiment, the controller may include multiple components, one or more of which may be disposed within the magnetic drive housing 204. According to an embodiment, the controller coupled to the motor 202 may be similar to that coupled to... Figure 1A The controller for the motor 102 shown.

[0070] like Figure 2A As shown, impeller assembly 206 is disposed within impeller assembly housing 208, which includes an inlet orifice (not shown) and a plurality of outlet orifices 212 defined therein. A longitudinal axis 242 extends through impeller assembly 206. According to an embodiment, magnetic drive housing 204 and impeller assembly housing 208 may be integrated together. In other embodiments, magnetic drive housing 204 and impeller assembly housing 208 may be separate components configured to be removably or permanently coupled together. Impeller assembly 206 includes an impeller 216 and a driven magnet 218 coupled to the impeller 216. The driven magnet 218 and impeller 216 may be coupled in various ways, including using adhesives, mechanical connections, or interference fits. The driven magnet 218 may be any type of magnetic rotor capable of being driven by drive magnet 220. As a magnetic field is applied to the driven magnet 218 via the driving magnet 220, the driven magnet 218 rotates, thereby causing the impeller 216 to rotate. The rotation of the impeller 216 causes blood to flow through the blood pump 200.

[0071] Figure 2B Embodiments of the subject matter disclosed herein are shown Figure 2A The image shows a perspective view of the blood pump 200. As shown, the impeller assembly 206 (including the impeller 216) is disposed within the impeller assembly housing 208, which includes an inlet port 210 and a plurality of outlet ports 212.

[0072] like Figure 2A As shown, the driven magnet 218 and the impeller 216 can be connected via a drive shaft 214, which is connected to the impeller 216 and configured to rotate together with the impeller 216. The driven magnet 218 can be connected to the drive shaft 214 and the impeller 216 in various ways, including by adhesive, mechanical connection, or interference fit. The drive shaft 214 may be at least partially disposed within the impeller 216. The drive shaft 214 may also be at least partially surrounded by the driven magnet 218. The drive shaft 214 can be made of any number of different rigid materials, such as, for example, steel, titanium alloy, cobalt-chromium alloy, nickel-titanium, high-strength ceramic, etc.

[0073] like Figure 2A As shown, the impeller assembly 206 (including the driven magnet 218) is held within the impeller assembly housing 208 by a bearing assembly 226. According to an embodiment, the bearing assembly 226 may be located near the distal side 224 of the driven magnet 218. According to an embodiment, the bearing assembly 226 may include different types of bearings. The bearing assembly 226 may also include a lubrication portion, while in other embodiments, the bearing assembly 226 may not include a lubrication portion. Figure 2A As shown, bearing assembly 226 includes a magnet bearing 228 and a housing bearing 230. The driven magnet 218 may have a reduced diameter portion (such as a distal shoulder 236) to facilitate the fixation of the magnet bearing 228 to the driven magnet 218. As shown, bearing assembly 226 has a proximal side 232 that contacts the distal surface of the distal shoulder 236 of the driven magnet 218. As shown, housing bearing 230 includes a proximal inner lip 231 that contacts the magnet bearing 228. The proximal inner lip 231 bears thrust loads and prevents the driven magnet 218 from bottoming out against the proximal end 233 of the impeller assembly housing 208.

[0074] As referenced above Figure 2A As described, bearing assembly 226 (including magnet bearing 228 and housing bearing 230) is positioned longitudinally near the center of mass of impeller assembly 206. Bearing assembly 226 is optimized when magnet bearing 228 and housing bearing 230 are aligned with the center of mass of impeller assembly 206. The position of bearing assembly 226 may be offset from the center of mass of impeller assembly 206 by approximately 0.050 inches based on practical considerations of the component assembly, but is optimized when longitudinally positioned as close as possible to the center of mass of impeller assembly 206.

[0075] like Figure 2A As shown, cavity 234 is formed by the proximal side 232 of bearing assembly 226, impeller assembly housing 208, and driven magnet 218. Compared to Figure 1A The driven magnet 116 shown, by increasing the size of the driven magnet 218, the size of the cavity 234 is compared to... Figure 1A The cavity 132 shown is reduced in size. In some embodiments, liquid may be disposed within the cavity 234, as described above. In other embodiments, the cavity 234 may be left empty.

[0076] according to Figure 2AIn one embodiment, the magnet bearing 228 may be mounted on a housing bearing 230 outside the impeller assembly housing 208, such that the distal sides of the magnet bearing 228 and the housing bearing 230 are flush with each other. The distal side 224 of the driven magnet 218 may then be coupled to the proximal side of the magnet bearing 228. The magnet bearing 228 and the driven magnet 218 may be coupled via press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art. As shown, the driven magnet 218 may include a proximal shoulder 238, and the drive shaft 214 may include a head 240. The drive shaft 214 may be positioned through the proximal inner diameter of the driven magnet 218 until the drive shaft head 240 abuts against the proximal shoulder 238 of the driven magnet 218 and is engaged in place, as described above. The impeller 216 can then be mounted on the drive shaft 214 and coupled in place via press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art. The order in which the drive shaft 214 and the impeller 216 are coupled can be the reverse of that described above. In other embodiments, the drive shaft 214 can be omitted, and the impeller 216 can be coupled in place to the driven magnet 218 via press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art. The impeller assembly 206 and the bearing assembly 226 can then be mounted in the impeller assembly housing 208 and coupled in place via press-fit, adhesive, mechanical connection, sintering, welding, or any method known to those skilled in the art.

[0077] As shown, the outer diameter of the driven magnet 218 may be larger than the inner diameter of the housing bearing 230, except where the magnet bearing 228 is fixed to the driven magnet 218. For example, in such embodiments, the driven magnet 218 may include a reduced-diameter portion (such as the distal shoulder 236) to accommodate the magnet bearing 228 and the housing bearing 230, such that the outer diameter of the combination of the driven magnet 218, the magnet bearing 228, and the housing bearing 230 is approximately the same as the outer diameter of the rest of the driven magnet 218. In other words, the outer diameter of the driven magnet 218 may be very close to the inner diameter of the impeller assembly housing 208, except at the distal shoulder 236 of the driven magnet 218. By increasing the size of the distal shoulder 236 and mounting the magnet bearing 228 and the housing bearing 230 onto the driven magnet 218, a larger driven magnet can be used with... Figure 1A Compared to the embodiments shown, the dimensions and / or thickness of the bearing assembly 226 can be adjusted. In some embodiments, the bearing assembly 226 may be thicker to maintain its mechanical integrity and durability.

[0078] Figures 2A to 2BThe illustrative loop support device 200 shown is not intended to represent any limitation on the scope of use or functionality of the embodiments of this disclosure. Nor should the illustrative loop support device 200 be construed as having any dependency or requirement relating to any individual component or combination of components shown herein. Furthermore, in the embodiments, Figures 2A to 2B The various components shown may be integrated with other components shown herein (and / or components not shown), all of which are considered to be within the scope of this disclosure.

[0079] Previous magnetically driven blood pumps are known to incorporate at least two bearing assemblies, with one bearing assembly positioned near the proximal end of the impeller assembly and the other near the distal end of the impeller assembly, to control the longitudinal and radial movement of the impeller assembly. Such designs with bearings mounted on the longitudinal end of the impeller are based on bearings with incorporated features that apply a force orthogonal to the longitudinal axis to prevent longitudinal movement of the impeller in either direction. Fillet features or shaft-diameter bearing-like features are incorporated on the distal and proximal bearings to control radial movement. Such designs typically achieve impeller rotational control through a total of four to six blood-contacting components. In such designs, the bearing assembly near the proximal end of the impeller assembly may be positioned between the magnetic field source and the driven magnet.

[0080] The bearing assemblies 124 and 226 are longitudinally positioned near the center of mass of the impeller assemblies 106 and 206 (e.g., ...). Figures 1A to 2B One advantage of the embodiment shown is that a bearing is not necessarily required between the driven magnets 116, 218 and the magnetic field sources 101, 201. Therefore, compared to a design where the bearing assembly is located near the proximal end of the impeller assembly, the driven magnets 116, 218 and the magnetic field sources 101, 201 can be positioned much closer together. For example, in Figures 1A to 2BIn the illustrated embodiment, the distance between the drive magnets 118, 220 and the magnetic field sources 101, 210 can be as small as 0.012 inches, and preferably less than 0.030 inches. By reducing the distance between the driven magnets 118, 220 and the magnetic field sources 101, 201, there is less magnetic flux loss in terms of space, which increases the transmission of magnetic torque. By reducing the spatial distance from the magnetic field sources 101, 201 to the driven magnets 116, 218, the improved capture of the magnetic flux of the magnetic field sources 101, 201 allows for larger torque in higher flow rate designs, the use of more corrosion-resistant magnets, and a smaller form factor. The reduced distance between the driven magnets 116, 218 and the magnetic field sources 101, 201 can increase the magnetic torque transmitted to the driven magnets 116, 218 by more than 100%. The reduced spacing between the magnetic field sources and the driven magnets also allows for the use of non-mechanical contact magnetic fields to control longitudinal forces, impeller rotation, and stability. Furthermore, such an arrangement improves magnet durability. Furthermore, the reduced distance between the magnetic field sources 101, 201 and the driven magnets 116, 218 allows for the use of a mechanical housing on the driven magnets 116, 218 (as described below). Figures 3A to 3B (as shown), or the use of more corrosion-resistant magnetic materials (such as samarium cobalt), or the use of more durable magnets with lower magnetic strength. Such arrangements can also provide opportunities to improve the power efficiency of battery-powered blood pumps.

[0081] Furthermore, reducing the distance between magnetic field sources 101, 201 and driven magnets 116, 218 allows for the use of smaller drive magnets, improved efficiency of the electromagnetic coils, and / or smaller driven magnets to produce the same blood flow rate as designed, which incorporates larger drive and driven magnets separated by a greater distance. The flow rate of a blood pump depends on torque transmission, the overall pump design (including impeller size and operating speed), the impeller design, and the flow cavity that determines the flow profile. For a given pump design and target flow rate, a certain amount of torque is required to drive the impeller assembly. Magnetic coupling can transmit this amount of torque. The amount of torque that can be transmitted is a function of magnet size and spacing. Generally, larger torque can be transmitted using larger magnets and / or magnets with closer spacing. In some embodiments, the dimensions of the drive and / or driven magnets can be adjusted to match the torque requirements of the desired flow rate of the blood pump. Other considerations can affect magnet size, including the blood pump form factor, magnet material, and the magnet's contribution to hemolysis. Reducing the size of the driven magnet can also reduce the amount of hemolysis caused by using a blood pump, for example by allowing a larger space between the impeller assembly housing and the driven magnet; and thus reduce the shear stress on the blood acting in such areas (such as cavities 132, 234).

[0082] Figures 1A to 2BAnother advantage of the illustrated embodiment is that the impeller assemblies 106, 206 can be controlled longitudinally and radially with only a single bearing assembly. As mentioned above, prior blood pumps are known to incorporate at least two bearing assemblies, typically positioning one bearing assembly near the proximal end of the impeller assembly and the other near the distal end to control the longitudinal and radial movement of the impeller assembly. In contrast, by requiring only one bearing assembly, the embodiments disclosed herein reduce the number of blood-contact bearing assemblies, and preferably reduce the number of bearings to two. Reducing the number of surfaces exposed to blood lowers the risk of hemolysis and thrombosis caused by blood interacting with the bearing surfaces. This arrangement also simplifies the assembly of the blood pump and reduces the rigid length of the blood pump, which improves delivery in transdermal devices. The simplification of the number of components interacting in a tightly controlled manner also benefits the manufacturability of the blood pump and its components.

[0083] Another related advantage of the embodiments disclosed herein is that the bearing assemblies 124, 226 are positioned near or longitudinally aligned with the center of mass of the impeller assemblies 106, 206, and this positioning improves the overall radial stability of the impeller assemblies 106, 206 by controlling the movement of the impeller assemblies 106, 206 at a position close to their center of mass. This positioning of the bearing assemblies 124, 226 also prevents component imbalance that causes eccentric impeller movement, which can result in an increased shear rate on the blood flowing through the blood pumps 100, 200.

[0084] Figure 3A A perspective view of an embodiment of the bearing assembly 300 is shown according to embodiments of the subject matter disclosed herein; and 3B shows an embodiment of the bearing assembly 300 according to embodiments of the subject matter disclosed herein. Figure 3A The image shows a cross-sectional side view of the bearing assembly 300. According to an embodiment, the bearing assembly 300 and / or any number of its various components may be identical or similar to... Figures 1A to 1D The illustrated cyclic support device 100, and / or Figures 2A to 2B The corresponding component of the circulating support device 200 shown.

[0085] like Figure 3A and Figure 3BAs shown, bearing assembly 300 includes a magnet bearing 302 and a housing bearing 304. The magnet bearing 302 completely encapsulates the driven magnet 306 and functions as a hermetically sealed element for the driven magnet 306. The housing bearing 304 is located near the impeller 308 and is mounted on an impeller assembly housing (not shown). The driven magnet 306 may be made of a material such as Ne-Fe-B (neodymium), which is easily corroded upon contact with blood. Bearing assembly 300 (including magnet bearing 302 and housing bearing 304) may be made of a corrosion-resistant material such as silicon nitride, sapphire, Vespel, polyamide-imide (torlon), PTFE, or any other corrosion-resistant material known to those skilled in the art. Therefore, in some embodiments, completely encapsulating the driven magnet 306 reduces its susceptibility to corrosion and increases durability. In other embodiments, the driven magnet 306 itself may be made of samarium cobalt to improve corrosion resistance and durability.

[0086] like Figure 3B As shown, the magnet bearing 302 can be fitted into the housing bearing 304 via a wedge shape 310. In some embodiments, this shape may be "U" or "V". In other embodiments, the fitting may be an alternative design that combines longitudinal and radial control by alternatively being an angular contact design. In other embodiments, the magnet bearing 302 and the housing bearing 304 may be designed to prevent the accumulation of heat, friction, or other problems detrimental to the operation or structural integrity of the bearing assembly 300.

[0087] Figure 3A and Figure 3B The exemplary bearing assembly 300 shown is not intended to represent any limitation on the scope of use or functionality of the embodiments of this disclosure. Nor should the exemplary bearing assembly 300 be construed as having any dependency or requirement relating to any individual component or combination of components shown herein. Furthermore, in the embodiments, Figure 3A and Figure 3B The various components shown may be integrated with other components shown herein (and / or components not shown), all of which are considered to be within the scope of this disclosure.

[0088] Figure 4 A cross-sectional side view of an exemplary percutaneous mechanical circulatory support device 400 (also interchangeably referred to herein as a "blood pump") is shown according to an embodiment of the subject matter disclosed herein. According to the embodiment, the blood pump 400 and / or any number of its various components may be identical to or similar to... Figure 1A and Figure 1B The corresponding component of the circulating support device 100 shown may be the same as or similar to that of the device. Figure 2A and Figure 2B The corresponding component of the circulating support device 200 shown.

[0089] like Figure 4 As shown, the blood pump 400 includes a magnetic drive housing 402, which includes a magnetic field source 404 configured to generate a changing magnetic field to drive the rotation of an impeller 406 to provide blood flow through the blood pump 400. Figure 4 In the illustrated embodiment, the magnetic field source 404 includes a permanent drive magnet 408 that is rotated by a motor 410 and configured to cause rotation of a permanent driven magnet 412 coupled to an impeller 406 to provide blood flow through the blood pump 400. As shown, the driven magnet 412 includes a proximal side 414 and a distal side 416. In an alternative embodiment, as described above but not shown herein, the magnetic field source 404 may include a set of electromagnetic coils or a stator and motor for generating a magnetic field to cause rotation of a permanent driven magnet coupled to an impeller to provide blood flow through the blood pump.

[0090] A controller (not shown) is operatively coupled to and configured to control the motor 410. In one embodiment, the controller may be located within the motor 410; or in other embodiments, it may be located outside the motor 410 (e.g., in a catheter stem, a separate housing, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located within the motor 410. According to some embodiments, the controller coupled to the motor 410 may be similar to that coupled to a... Figure 1A The controller for the described motor 102.

[0091] like Figure 4 As shown, an impeller assembly 418 is disposed within an impeller assembly housing 420, which includes an inlet orifice 422 and a plurality of outlet orifices 424 defined therein. A longitudinal axis 426 extends through the impeller assembly 418. According to some embodiments and as shown, the magnetic drive housing 402 and the impeller assembly housing 420 may be integrated together. In other embodiments, the magnetic drive housing 402 and the impeller assembly housing 420 may be separate components configured to be removably or permanently coupled together. The impeller assembly 418 includes an impeller 114 and a driven magnet 412. The driven magnet 412 and the impeller 406 may be coupled in various ways, including using adhesives, mechanical connections, or interference fits. The driven magnet 412 may be any type of magnetic rotor capable of being driven by a magnetic field source 404. As a magnetic field is applied to the driven magnet 412 through the magnetic field source 404, the driven magnet 412 rotates, thereby causing the impeller 406 to rotate. The rotation of impeller 406 causes blood to flow through blood pump 400.

[0092] like Figure 4As shown, the driven magnet 412 and the impeller 406 can be connected via a drive shaft 428, which is connected to the impeller 406 and configured to rotate together with the impeller 406. The driven magnet 412 can be connected to the drive shaft 428 and the impeller 406 in various ways, including by adhesive, mechanical connection, or interference fit. The drive shaft 428 may be at least partially disposed within the impeller 406. The drive shaft 428 may also be at least partially surrounded by the driven magnet 412. The drive shaft 428 can be made of any number of different rigid materials, such as, for example, steel, titanium alloy, cobalt-chromium alloy, nickel-titanium, high-strength ceramic, etc.

[0093] like Figure 4 As shown, the impeller assembly 418 is coupled to and held within the impeller assembly housing 420 via a bearing assembly 430. According to some embodiments, the bearing assembly 430 may be located near the distal side 416 of the driven magnet 412. According to some embodiments, the bearing assembly 430 may include different types of bearings. The bearing assembly 430 may also include a lubrication portion, while in other embodiments, the bearing assembly 430 may not include a lubrication portion. Figure 4 As shown, bearing assembly 430 includes a first bearing 432 and a second bearing 434. The first bearing 432 may also be referred to as a housing bearing, and the second bearing 434 may also be referred to as a thrust bearing. The thrust bearing 434 rotates together with the shaft 428 and other components of the impeller assembly 418. The thrust bearing 434 contacts the proximal side 436 of the impeller 406 and the distal side 438 of the housing bearing 432. Bearing assembly 430 (including the first bearing 432 and the second bearing 434) may be made of one or more corrosion-resistant materials, such as silicon nitride, ceramic, sapphire, Vespel, polyamide-imide (torlon), PTFE, or any other corrosion-resistant material known to those skilled in the art.

[0094] Continue to refer to Figure 4The housing bearing 432 contacts the impeller assembly housing 420. More specifically, the impeller assembly housing 420 includes a recess or pit 440 that receives the housing bearing 432. The housing bearing 432 rotatably carries the shaft 428, and the housing bearing 432 includes rounded outer corners 442, which reduce or minimize hemolysis of blood flowing through the device 400. In some embodiments, the housing bearing 432 reduces or minimizes the amount of blood contacting the driven magnet 412 by means of the driven magnet 412 following the housing bearing 432, which can help reduce hemolysis. In some embodiments, the housing bearing 432 may be positioned longitudinally near the center of mass of the impeller assembly 418. The device 400 can be optimized when the housing bearing 432 is aligned with the center of mass of the impeller assembly 418. The position of the housing bearing 432 may be offset from the center of mass of the impeller assembly 418 by approximately 0.050 inches based on practical considerations of the component assembly, but is optimized when longitudinally positioned as close as possible to the center of mass of the impeller assembly 418. In other embodiments, the housing bearing 432 may not be aligned with the center of mass of the impeller assembly 418, or the position of the housing bearing 432 may be offset from the center of mass of the impeller assembly 418 by a greater distance, depending on the size and construction of the housing bearing 432.

[0095] Bearing assembly 430 is used to control the forces associated with impeller assembly 418. Partially, bearing assembly 430 utilizes the magnetic force of driven magnet 412 to control the axial load on impeller assembly 418. Specifically, the axial attraction between magnetic field source 404 and driven magnet 412 is greater than the thrust of impeller assembly 418, which pushes impeller assembly 418 in the distal direction; and thus prevents axial movement of impeller assembly 418 in the distal direction. Thrust bearing 434 provides axial control by counteracting the axial magnetic attraction between magnetic field source 404 and driven magnet 412. Housing bearing 432 provides radial control of impeller assembly 418.

[0096] Continue to refer to Figure 4 The impeller assembly housing 420 includes a channel 444 located proximal to at least one of a plurality of outlet orifices 424. The channel 444 is configured to receive a guide wire (not shown) that travels from within the impeller housing 420 to the outside of the impeller housing 420 via one of the plurality of outlet orifices 424. In some embodiments, the channel 444 may extend the entire length of the housing bearing 432. The channel 444 provides surfaces for a gradual transition of the guide wire from within the impeller housing 420 to the outside of the impeller housing 420, thereby reducing the chance of damage to the guide wire due to contact with the impeller housing 420 and reducing the angle of the guide wire during the transition from within the impeller housing 420 to the outside of the impeller housing 420. The stationary surface of the housing bearing 432 may allow features such as adhesive chamfering or flexible polymer components to prevent the proximal edge of the outlet orifice 424 from having a metallic edge that could damage the guide wire.

[0097] Positioning such as Figure 4 One advantage of the illustrated bearing assembly 430 is that a bearing is not necessarily required between the driven magnet 412 and the magnetic field source 404. Therefore, the driven magnet 412 and the magnetic field source 404 can be positioned much closer together compared to a design where the bearing assembly is located near the proximal end of the impeller assembly. For example, in the illustrated embodiment, the distance between the driven magnet 412 and the magnetic field source 404 can be as low as 0.012 inches, preferably less than 0.020 inches, and more preferably less than 0.030 inches. By reducing the distance between the driven magnet 412 and the magnetic field source 404, there is less magnetic flux loss in terms of space, which increases the transmission of magnetic torque. The improved magnetic flux capture of the magnetic field source 404 by reducing the spatial distance from the magnetic field source 404 to the driven magnet 412 allows for larger torques in higher flow rate designs, the use of more corrosion-resistant magnets, and smaller form factors. The reduced distance between the driven magnet 412 and the magnetic field source 404 can increase the magnetic torque transmitted to the driven magnet 412 by more than 100%.

[0098] Another advantage of device 400 is that the impeller assembly 418 can be controlled longitudinally and radially with only a single bearing assembly. As mentioned above, previous blood pumps are known to incorporate at least two bearing assemblies, typically positioning one bearing assembly near the proximal end of the impeller assembly and the other near the distal end to control the longitudinal and radial movement of the impeller assembly. In contrast, device 400 lacks a bearing assembly at the distal end 444 of the impeller 406, thereby reducing the number of bearing assemblies in contact with blood and preferably reducing the number of bearings to two. Also, as mentioned above, reducing the number of surfaces or structures exposed to blood reduces the risk of hemolysis and thrombosis, and also reduces the overall rigid length of the blood pump.

[0099] In some embodiments, the method of assembling the device 400 may include the following actions. Initially, a shaft is located in an impeller 406, and a thrust bearing 434 is located on the shaft 428 and abuts against the proximal side 436 of the impeller 406. The thrust bearing 434 is then secured to the shaft 428 or the impeller 406 (e.g., via adhesive, press-fit, mechanical connection, sintering, welding, or any method known to those skilled in the art). Then, a housing bearing 432 is positioned on the shaft 428 proximal to the thrust bearing 434, and a driven magnet 412 is positioned on the shaft 428 proximal to the housing bearing 432. Next, the driven magnet 412 is secured to the shaft 428 (e.g., via adhesive, press-fit, mechanical connection, sintering, welding, or any method known to those skilled in the art). Then, the impeller assembly 418 and the bearing assembly 430 are located in the impeller assembly housing 420, and the housing bearing 432 is fixed to the impeller assembly housing 420 (e.g., via adhesive, press fit, mechanical connection, sintering, welding or any method known to those skilled in the art).

[0100] Figure 4 The illustrative loop support device 400 shown is not intended to represent any limitation on the scope of use or functionality of the embodiments of this disclosure. Nor should the illustrative loop support device 400 be construed as having any dependency or requirement relating to any individual component or combination of components shown herein. Furthermore, in the embodiments, Figure 4 The various components shown may be integrated with other components shown herein (and / or components not shown), all of which are considered to be within the scope of this disclosure.

[0101] Figure 5 A cross-sectional side view of an exemplary percutaneous mechanical circulatory support device 500 (also interchangeably referred to herein as a "blood pump") is shown according to an embodiment of the subject matter disclosed herein. According to the embodiment, the blood pump 500 and / or any number of its various components may be identical to or similar to... Figure 1A and Figure 1B The corresponding components of the circulating support device 100 shown may be the same as or similar to those of the other components. Figure 2A and Figure 2B The corresponding components of the circulating support device 200 shown may be the same as or similar to those shown. Figure 4 The corresponding component of the circulating support device 400 shown.

[0102] like Figure 5 As shown, the blood pump 500 includes a magnetic drive housing 502, which includes a magnetic field source 504 configured to generate a changing magnetic field to drive the rotation of an impeller 506 to provide blood flow through the blood pump 500. Figure 5In the illustrated embodiment, the magnetic field source 504 includes a permanent drive magnet 508, which is rotated by a motor 510 and configured to cause rotation of a permanent driven magnet 512, which is coupled to an impeller 506 to provide blood flow through the blood pump 500. As shown, the driven magnet 512 includes a proximal side 514 and a distal side 516. In an alternative embodiment, as described above but not shown herein, the magnetic field source 504 may include a set of electromagnetic coils or a stator and a motor for generating a magnetic field to cause rotation of a permanent driven magnet coupled to an impeller to provide blood flow through the blood pump.

[0103] A controller (not shown) is operatively coupled to and configured to control the motor 510. In some embodiments, the controller may be located within the motor 510; or in other embodiments, it may be located outside the motor 510 (e.g., in a catheter stem, a separate housing, etc.). In some embodiments, the controller may include a plurality of components, one or more of which may be located within the motor 510. According to some embodiments, the controller coupled to the motor 510 may be similar to a combination of... Figure 1A The controller described is connected to motor 102.

[0104] like Figure 5 As shown, an impeller assembly 518 is disposed within an impeller assembly housing 520, which includes an inlet orifice 522 and a plurality of outlet orifices 524 defined therein. A longitudinal axis 526 extends through the impeller assembly 518. According to some embodiments and as shown, the magnetic drive housing 502 and the impeller assembly housing 520 may be integrated together. In other embodiments, the magnetic drive housing 502 and the impeller assembly housing 520 may be separate components configured to be removably or permanently coupled together. The impeller assembly 518 includes an impeller 506 and a driven magnet 512. The driven magnet 512 and the impeller 506 may be coupled in various ways, including using adhesives, mechanical connections, or interference fits. The driven magnet 512 may be any type of magnetic rotor capable of being driven by a magnetic field source 504. As a magnetic field is applied to the driven magnet 512 through the magnetic field source 504, the driven magnet 512 rotates, thereby causing the impeller 506 to rotate. The rotation of impeller 506 causes blood to flow through blood pump 500.

[0105] like Figure 5As shown, the driven magnet 512 and the impeller 506 can be connected via a drive shaft 528, which is connected to the impeller 506 and configured to rotate together with the impeller 506. The driven magnet 512 can be connected to the drive shaft 528 and the impeller 506 in various ways, including by adhesive, mechanical connection, or interference fit. The drive shaft 528 may be at least partially disposed within the impeller 506. The drive shaft 528 may also be at least partially surrounded by the driven magnet 512. The drive shaft 528 can be made of any number of different rigid materials, such as, for example, steel, titanium alloy, cobalt-chromium alloy, nickel-titanium, high-strength ceramic, etc.

[0106] like Figure 5 As shown, the impeller assembly 518 is coupled to and held within the impeller assembly housing 520 via a proximal bearing assembly 530. According to some embodiments, the proximal bearing assembly 530 may be located near the distal side 516 of the driven magnet 512. According to some embodiments, the proximal bearing assembly 530 may include different types of bearings. The proximal bearing assembly 530 may also include a lubrication portion, while in other embodiments, the proximal bearing assembly 530 may not include a lubrication portion. Figure 5 As shown, the proximal bearing assembly 530 includes a first bearing 532 and a second bearing 534. The first bearing 532 may also be referred to as a housing bearing, and the second bearing 534 may also be referred to as a thrust bearing. A third bearing 536 (which may also be referred to as a distal bearing) is also included within the impeller assembly 520 and coupled to the impeller assembly 518. The thrust bearing 534 contacts the proximal side 538 of the impeller 506 and the distal side 540 of the housing bearing 532. The distal bearing 536 is positioned distally relative to the impeller 506 and contacts the distal support 542, which in turn contacts the impeller assembly housing 520. The proximal bearing assembly 530 and the distal bearing 536 may be made of one or more corrosion-resistant materials, such as silicon nitride, ceramics, sapphire, Vespel, polyamide-imide (torlon), PTFE, or any other corrosion-resistant material known to those skilled in the art.

[0107] Continue to refer to Figure 5The housing bearing 532 contacts the impeller assembly housing 520. More specifically, the impeller assembly housing 520 includes a recess or pit 544 for receiving the housing bearing 532. The housing bearing 532 rotatably carries the shaft 528. In some embodiments, the housing bearing 532 reduces or minimizes the amount of blood contacting the driven magnet 512, which can help reduce hemolysis. In particular, the housing bearing 532 may include rounded outer corners 546, which reduce or minimize hemolysis of blood flowing through the device 500. In some embodiments, the housing bearing 532 reduces or minimizes the amount of blood contacting the driven magnet 512 by having the driven magnet 512 after it, which can help reduce hemolysis. In some embodiments, the housing bearing 532 may be positioned longitudinally near the center of mass of the impeller assembly 518, as previously described. The device 500 can be optimized when the housing bearing 532 is aligned with the center of mass of the impeller assembly 518. In other embodiments, the housing bearing 532 may not be aligned with the center of mass of the impeller assembly 518, depending on the size and construction of the housing bearing 532.

[0108] In some embodiments, and as shown, the driven magnet 512 and the magnetic field source 504 are positioned much closer together than in a design where the bearing assembly is located near the proximal end of the impeller assembly. For example, in the illustrated embodiment, the distance between the driven magnet 512 and the magnetic field source 504 can be as small as 0.012 inches, preferably less than 0.020 inches, and more preferably less than 0.030 inches. By reducing the distance between the driven magnet 512 and the magnetic field source 504, there is less magnetic flux loss in terms of space, which increases the transmission of magnetic torque. The improved capture of magnetic flux from the magnetic field source 504 to the driven magnet 512 by reducing the spatial distance allows for larger torque in higher flow rate designs, the use of more corrosion-resistant magnets, and a smaller form factor. The reduced distance between the driven magnet 512 and the magnetic field source 504 can increase the magnetic torque transmitted to the driven magnet 512 by more than 100%.

[0109] In some embodiments, the method of assembling device 500 may be similar to the method of assembling device 400 described above. Furthermore, before or after securing housing bearing 532 and impeller assembly 518 to impeller assembly housing 520, distal bearing 536 and distal support 542 may be secured to each other and / or to impeller assembly housing 520 (e.g., via adhesive, press fit, mechanical connection, sintering, welding, or any method known to those skilled in the art).

[0110] Figure 5The illustrative loop support device 500 shown is not intended to represent any limitation on the scope of use and functionality of the embodiments of this disclosure. Nor should the illustrative loop support device 500 be construed as having any dependency or requirement relating to any individual component or combination of components shown herein. Furthermore, in the embodiments, Figure 5 The various components shown may be integrated with other components shown herein (and / or components not shown), all of which are considered to be within the scope of this disclosure.

[0111] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the embodiments described above refer to specific features, the scope of this disclosure also includes embodiments with different combinations of features and embodiments that do not include all described features. Therefore, the scope of this disclosure is intended to cover all such alternatives, modifications, and variations, as well as all equivalents, that fall within the scope of the claims.

Claims

1. A blood pump comprising: Magnetic field source; An impeller assembly includes a longitudinal axis, an impeller, and a driven magnet, the driven magnet being longitudinally biased and disposed distally relative to a magnetic field source, the driven magnet being rotatable and longitudinally controlled by the magnetic field source, and the driven magnet including a distal side facing the impeller, wherein the impeller assembly has a center of mass; and A bearing assembly located near the distal side of the driven magnet, wherein the bearing assembly is longitudinally aligned with the center of mass of the impeller assembly, such that the bearing assembly controls the longitudinal and radial movement of the impeller assembly and prevents eccentric movement of the impeller, and wherein the blood pump comprises only one bearing assembly.

2. The blood pump of claim 1, further comprising an impeller assembly housing, the bearing assembly contacting the impeller assembly housing, and the impeller assembly housing rotatably carrying the impeller assembly via the bearing assembly.

3. The blood pump according to claim 2, wherein, The impeller assembly housing includes a recess that receives the bearing assembly.

4. The blood pump according to any one of claims 1 to 3, wherein, The distance between the magnetic field source and the driven magnet is less than 0.030 inches.

5. The blood pump according to any one of claims 1 to 3, wherein, No part of the bearing assembly is located between the driven magnet and the magnetic field source.

6. The blood pump according to claim 2 or 3, wherein, The impeller assembly housing does not include a bearing assembly located at the distal end of the impeller.

7. The blood pump according to any one of claims 1 to 3, wherein, The impeller assembly is rotatable about the longitudinal axis, and the bearing assembly is arranged radially outward relative to the longitudinal axis.

8. The blood pump according to claim 2 or 3, wherein, The impeller assembly further includes a shaft coupled to and rotatable with the impeller, and the bearing assembly contacts the shaft and the impeller assembly housing.

9. The blood pump according to any one of claims 1 to 3, wherein, The bearing assembly has a proximal side that contacts the distal side of the driven magnet.

10. A blood pump, comprising: Magnetic field source; An impeller assembly including a longitudinal axis, an impeller, and a driven magnet, the driven magnet being longitudinally biased and disposed distally relative to a magnetic field source, the driven magnet being rotatable and longitudinally controlled by the magnetic field source, wherein the impeller assembly has a center of mass; and A bearing assembly coupled to the impeller assembly, wherein no part of the bearing assembly is located between the driven magnet and the magnetic field source, and wherein the bearing assembly is longitudinally aligned with the center of mass of the impeller assembly such that the bearing assembly controls the longitudinal and radial movement of the impeller assembly and prevents eccentric movement of the impeller, and wherein the blood pump comprises only one bearing assembly.

11. The blood pump of claim 10, further comprising an impeller assembly housing, the bearing assembly contacting the impeller assembly housing, and the impeller assembly housing rotatably carrying the impeller assembly via the bearing assembly.

12. The blood pump according to claim 11, wherein, The impeller assembly housing includes a recess that receives the bearing assembly.

13. The blood pump according to any one of claims 10 to 12, wherein, The bearing assembly contacts the driven magnet.

14. The blood pump according to any one of claims 10 to 12, wherein, The bearing assembly includes a magnetic bearing that encapsulates the driven magnet.

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