Percutaneous blood pump with motor connection

Abstract

A transcutaneous circulatory support device includes a transcutaneous blood pump. The blood pump can include an impeller housing, an impeller disposed in the impeller housing, a bearing assembly, a motor housing, a motor disposed in the motor housing, and a flexible elongate shaft. The flexible elongate shaft can have a proximal portion coupled with the motor housing and a distal portion coupled with the bearing assembly. The flexible elongate shaft can have a first outer diameter between the motor housing and the bearing assembly, and the impeller housing can have a second outer diameter that is greater than the first outer diameter.

Description

Cross-reference to related applications

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 605,824, filed December 4, 2023, which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to a circulation support device. More specifically, this disclosure relates to a transcutaneous circulation support device comprising a flexible connection between a motor housing and an impeller housing. Background Technology

[0003] Percutaneous mechanical circulatory support devices (such as blood pumps) can provide short-term support for hours or months in patients with impaired cardiac function or cardiac output. Percutaneous mechanical circulatory support devices can be flexible enough to be navigated through the vascular system to the patient's heart. For example, such devices can be navigated across the aortic arch and placed across the aortic valve. Various constructions of percutaneous mechanical circulatory support devices are known. However, there has always been a need for improved constructions of percutaneous mechanical circulatory support devices. Summary of the Invention

[0004] This disclosure provides designs, materials, manufacturing methods, and alternatives for use in medical devices, including transcutaneous circulatory support devices and related transcutaneous blood pumps.

[0005] The first example is a blood pump comprising: an impeller housing; an impeller disposed in the impeller housing; a magnetic assembly in communication with the impeller; a motor housing; a motor disposed in the motor housing, wherein the motor is in communication with the magnetic assembly to drive the impeller; and a flexible elongated shaft coupled to the magnetic assembly and the motor housing, wherein the flexible elongated shaft may have a first outer diameter smaller than a second outer diameter of the impeller housing.

[0006] As an alternative or supplement to any of the above examples, in another example, the motor housing may have a third outer diameter, and the first outer diameter may be smaller than the third outer diameter.

[0007] As an alternative or supplement to any of the above examples, in another example, the flexible elongated shaft may have an elongated core member and an elongated outer shell extending along the elongated core member.

[0008] As an alternative or supplement to any of the above examples, in another example, the blood pump may further include a motor drive shaft, and the elongated core member may have a proximal portion communicating with the motor drive shaft and a distal portion communicating with the magnetic component.

[0009] As an alternative to or supplement to any of the above examples, in another example, the magnetic component may include a driven shaft, and the elongated core member may have a distal portion communicating with the driven shaft.

[0010] As an alternative to or supplement to any of the above examples, in another example, the magnetic component may be located within the impeller housing.

[0011] As an alternative or supplement to any of the above examples, in another example, the magnetic component may further include a driven magnet coupled to the impeller and a driving magnet, the driving magnet being fluidly isolated from the driven magnet and configured to drive the driven magnet.

[0012] As an alternative to or supplement to any of the above examples, in another example, the driven magnet may be located within the impeller housing.

[0013] As an alternative to or supplement to any of the above examples, in another example, the blood pump may also include a driven shaft having a proximal portion connected to the flexible elongated shaft and a distal portion connected to the drive magnet.

[0014] As an alternative to or supplement to any of the above examples, in another example, the blood pump may also include a bearing assembly connected to the impeller housing and the flexible elongated shaft.

[0015] In another example, the blood pump may include: an impeller housing; an impeller disposed in the impeller housing; a bearing assembly coupled to the impeller housing; a motor housing; a motor disposed in the motor housing; and a flexible elongated shaft having a proximal portion coupled to the motor housing and a distal portion coupled to the bearing assembly.

[0016] As an alternative to or supplement to any of the above examples, in another example, the flexible elongated shaft may have an elongated core member and an elongated housing extending along the elongated core member, the elongated housing being coupled to the bearing assembly.

[0017] As an alternative to or supplement to any of the above examples, in another example, the blood pump may further include a motor drive shaft, and the elongated core member may have a proximal portion communicating with the motor drive shaft.

[0018] As an alternative to or supplement to any of the above examples, in another example, the elongated core member may extend through the bearing assembly.

[0019] As an alternative or supplement to any of the above examples, in another example, the blood pump may further include a magnetic component coupled to the distal portion of the flexible elongated shaft, wherein the magnetic component may be configured to drive the impeller in response to actuation of the motor.

[0020] As an alternative or supplement to any of the above examples, in another example, the magnetic component may include a driven magnet coupled to the impeller and a driving magnet, the driving magnet being fluidly isolated from the driven magnet and coupled to the distal portion of the flexible elongated shaft to drive the driven magnet in response to actuation of the motor.

[0021] As an alternative to or supplement to any of the above examples, in another example, the blood pump may also include a driven shaft having a proximal portion extending through the bearing assembly and a distal portion coupled to the drive magnet.

[0022] As an alternative or supplement to any of the above examples, in another example, the flexible elongated shaft may have an elongated core member having a distal portion extending through the bearing assembly and connected to the drive magnet.

[0023] As an alternative to or supplement to any of the above examples, in another example, the elongated core member may include a flexible portion and a rigid portion, wherein the rigid portion extends through the bearing assembly and is coupled to the drive magnet.

[0024] In yet another example, the blood pump may include: an impeller housing; an impeller disposed in the impeller housing; a bearing assembly connected to the proximal end of the impeller housing; a motor housing; a motor disposed in the motor housing; and a flexible elongated shaft having a proximal portion connected to the motor housing and a distal portion connected to the bearing assembly, wherein the flexible elongated shaft may have a first outer diameter between the motor housing and the bearing assembly, and the impeller housing may have a second outer diameter larger than the first outer diameter.

[0025] The foregoing description of some of the constructions is not intended to describe every disclosed construction or implementation of the invention. The following figures and detailed descriptions illustrate some of these constructions in more detail. Attached Figure Description

[0026] This disclosure can be more fully understood in conjunction with the following detailed description of the embodiments, in conjunction with the accompanying drawings, in which:

[0027] Figure 1 It is a schematic perspective view of an illustrative transcutaneous circulation support device including a transcutaneous blood pump;

[0028] Figure 2 It includes a transcutaneous blood pump. Figure 1 A schematic perspective view of the distal region of an illustrative transdermal circulation support device;

[0029] Figure 3 yes Figure 1 A schematic side view of a portion of an illustrative percutaneous blood pump;

[0030] Figure 4 yes Figure 3 A schematic cross-sectional view of a portion of the illustrative percutaneous blood pump depicted in the image;

[0031] Figure 5 This is a schematic cross-sectional view of a portion of an illustrative percutaneous blood pump;

[0032] Figure 6 yes Figure 5 A schematic cross-sectional view of a portion of an illustrative percutaneous blood pump, depicting a slender, flexible member with a bend;

[0033] Figure 7 This is a schematic cross-sectional view of a portion of an illustrative percutaneous blood pump; and

[0034] Figure 8 This is a schematic cross-sectional view of a portion of an illustrative percutaneous blood pump.

[0035] While the implementation is readily adaptable to various modifications and alternatives, its details have been illustrated by way of example in the accompanying drawings and will be described in detail. Nevertheless, it should be understood that this disclosure is not intended to be limited to the specific constructions described. Rather, it is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of this disclosure. Detailed Implementation

[0036] The following definitions shall apply to terms unless otherwise defined in the claims or elsewhere in this specification.

[0037] Whether explicitly stated or not, all numerical values ​​herein are considered to be modified by the term "approximately". The term "approximately" generally refers to a range of numbers that a person skilled in the art would consider equivalent to the stated value (i.e., having the same function or result). In many cases, the term "approximately" may include numbers rounded to the nearest significant figure.

[0038] The range of values ​​listed by endpoints includes all values ​​within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0039] As used in this specification and the appended claims, the singular forms “a” and “the”, and where no quantifier is used, include plural indicators, unless otherwise expressly stated. As used in this specification and the appended claims, the term “or” is generally used in the sense that it includes “and / or”, unless otherwise expressly stated.

[0040] Note that references to "a construction," "some constructions," "other constructions," etc., in the specification indicate that the described construction may include one or more specific features, structures, and / or properties. However, such descriptions do not necessarily mean that all constructions include that specific feature, structure, and / or property. Furthermore, when a construction is used to describe a specific feature, structure, and / or property, it should be understood that these features, structures, and / or properties may also be used in conjunction with other constructions, whether explicitly described or not, unless explicitly stated otherwise.

[0041] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings (which are not necessarily to scale) depict illustrative structures and are not intended to limit the scope of this disclosure.

[0042] Figure 1 A perspective view of an exemplary percutaneous circulation support device 10 is depicted, comprising a percutaneous blood pump 50 located in its distal region. The percutaneous circulation support device 10 may be coupled to or include the blood pump 50, wherein an elongated shaft 12 of the percutaneous circulation support device 10 extends proximally from the percutaneous blood pump 50, and a distal tip 40 extends distally from the blood pump 50. For example, the proximal end 16 of the elongated shaft 12 may be coupled to a control module 14, and the distal end 18 of the elongated shaft 12 may be coupled to the percutaneous blood pump 50. An extension 26 may extend from the control module 14 to connect to a controller (not shown) for controlling the blood pump 50, for example, to provide power to the blood pump 50 and / or for sending and / or receiving signals (e.g., from one or more sensors during operation of the blood pump 50). In some cases, the extension 26 may transmit current to the blood pump 50 and / or transmit electrical and / or optical signals from diagnostic sensors (such as, but not limited to, blood pressure, blood flow velocity, etc.).

[0043] Figure 2Additional features of the blood pump 50 are described. The blood pump 50 typically includes a flexible sleeve 30, an impeller housing 60, and a motor housing 70. In some configurations, the flexible sleeve 30, impeller housing 60, and / or motor housing 70 may be constructed integrally or as a single piece. In other cases, the flexible sleeve 30, impeller housing 60, and / or motor housing 70 may be separate components. The impeller housing 60 carries an impeller assembly 65 therein. The impeller assembly 65 may include an impeller fixed to an impeller shaft, the impeller rotating relative to the impeller housing 60 to drive blood through the blood pump 50. In some configurations, the impeller and impeller shaft of the impeller assembly 65 may be integrally formed, while in other configurations, the impeller shaft and impeller may be separate components.

[0044] The rotation of the impeller causes blood to flow from the blood inlet 80 of the blood pump 50 (e.g., at the distal end of the flexible sleeve 30), through the flexible sleeve 30 and the impeller housing 60, and out from the blood outlet 90 proximal to the impeller (e.g., through a sidewall formed on the impeller housing 60). In some cases, the blood inlet 80 may include a plurality of blood inlet windows arranged circumferentially around the blood pump 50 (e.g., the flexible sleeve 30). In some cases, the blood outlet 90 may include a plurality of blood outflow windows arranged circumferentially around the impeller housing 60. In other configurations, the inlet 80 and / or the outlet 90 may be formed on other parts of the blood pump 50.

[0045] Continue to refer to Figure 2 The motor housing 70 carries the motor, which is configured to rotatably drive the impeller of the impeller assembly 65 relative to the impeller housing 60. For example, electricity can be supplied to the motor via a wire extending through the elongated shaft 12. In some cases, the motor may be physically connected to the impeller. For example, in some configurations, the impeller may be mounted on the motor's drive shaft or drive line. In other configurations, the impeller shaft may be directly or indirectly connected to the motor's drive shaft. In some cases, the drive assembly may be included in a magnetic connection between the motor and the impeller. For example, a drive magnet may be mounted on the motor's drive shaft or drive line. Rotation of the drive magnet causes rotation of a driven magnet connected to the impeller assembly 65. More specifically, in configurations including an impeller shaft, the impeller and impeller shaft of the impeller assembly 65 are configured to rotate together with the driven magnet. In other configurations, the motor may be connected to the impeller assembly 65 via other components.

[0046] Figure 3 This is a side view of a portion of the transdermal circulation support device 10, depicting a part of the transdermal blood pump 50 connected to the elongated shaft 12 at the junction 100. The proximal end of the impeller 67 of the impeller assembly 65 can also be seen through the outflow opening 62 of the blood outlet 90.

[0047] The joint 100 may include an end cap 110 having a proximal region surrounding a distal region of an elongated shaft 12, and a material fillet 120 surrounding and extending proximally from the proximal region of the end cap 110. The material fillet 120 may extend proximally to the end cap 110 and is a portion of the proximal extension of the elongated shaft 12 around the end cap 110.

[0048] Figure 4 yes Figure 3 A cross-sectional view of a portion of the transdermal circulation support device 10, which includes a junction 100 between the transdermal blood pump 50 of the transdermal circulation support device 10 and the elongated shaft 12. The junction 100 may be configured to mechanically connect the motor housing 70 of the blood pump 50 (e.g., a metal motor housing) or other components of the blood pump 50 to a distal region of the elongated shaft 12 (e.g., a polymer tubular member).

[0049] like Figure 4 As shown, impeller assembly 65 may include an impeller shaft 66 (e.g., a driven shaft) and an impeller 67 coupled thereto, wherein the impeller shaft 66 may be configured to rotate together with the impeller 67. As shown, the impeller shaft 66 may be at least partially disposed inside the impeller 67, but other suitable configurations are also contemplated.

[0050] The impeller assembly 65 may also include a driven magnet 78 coupled to and at least partially surrounding the impeller shaft 66 and / or the impeller 67. The driven magnet 78 may be any type of magnetic rotor capable of being driven by the drive magnet 76. In this way, due to the actuation of the motor 72, a magnetic field can be applied to the driven magnet 78 by the drive magnet 76, so the driven magnet 78 can rotate, causing the impeller shaft 66 and the impeller 67 to rotate.

[0051] like Figure 4 As shown, the magnetic assembly 73 may include a driven magnet 78 and a drive magnet 76 coupled to a drive shaft 74 (e.g., a motor drive shaft), the drive shaft 74 being configured to transmit torque from the motor 72 to the drive magnet 76. The motor housing 70 may be configured to hermetically seal (e.g., fluid-isolate) the drive magnet 76 and the motor within the motor housing 70, and thus fluidly isolate the drive magnet 76 from the driven magnet 78. Electrical wires (not shown) may extend through the cavity of the elongated shaft 12 to provide power to the motor 72. In other cases, the drive shaft 74 may be directly coupled to the impeller 67 and / or the impeller shaft 66, or other driven mechanisms may be provided to transmit torque from the motor 72 to the impeller 67.

[0052] like Figure 4As shown, the lengths of the impeller housing 60 and the motor housing 70 can form a first rigid length of the blood pump 50. This first rigid length can be any suitable length. In some cases, given the subject's anatomy, the rigid length of the blood pump 50 can determine where the blood pump 50 can be used in the subject (if any), because the longer the rigid length, the more difficult it may be to position the blood pump 50 in the subject and maintain it in the desired location.

[0053] In some cases, the blood pump 50 may be configured such that the impeller housing 60 and the motor housing 70 are separated by a flexible elongated shaft to reduce the length of the rigid portion of the blood pump 50 near the patient's heart (e.g., reduce the rigid length). Reducing the length of the rigid portion of the blood pump 50 configured to be near the patient's heart can facilitate insertion of the blood pump 50 into the patient's body, tracking the blood pump 50 along the patient's blood vessels to a target site (e.g., the ventricle of the patient's heart and / or other suitable target site) and / or operation of the blood pump 50. Furthermore, the flexible elongated shaft between the impeller housing 60 and the motor housing 70 may include a drive shaft 74 and / or may include a flexible elongated drive core configured to connect the drive shaft 74 to a drive magnet 76, allowing the motor 72 to drive the impeller 67 from a position spaced proximally from the impeller housing 60. Figures 5-7 Some parts of the construction of the transdermal circulation support device 10 with blood pump 50 are depicted, wherein the impeller housing 60 and the motor housing 70 are separated by a flexible elongated shaft 92.

[0054] Figure 5 A schematic cross-sectional view of a portion of the percutaneous circulation support device 10 is depicted, wherein the components of the depicted percutaneous circulation support device 10 are axially aligned. For example... Figure 5 As shown, the motor housing 70 can be spaced apart from the magnetic assembly 73 and the impeller housing 60 on the proximal side by a flexible elongated shaft 92 and one or more bearing assemblies 82. Figure 5 As shown, a flexible elongated shaft 92 may extend between the impeller housing 60 and the motor housing 70, with one or more bearing assemblies 82 located on the distal side of the flexible elongated shaft 92. In some examples, the flexible elongated shaft 92 may be coupled to the motor 72 and / or the motor housing 70 and the magnetic assembly 73. In operation, the impeller 67 may be driven in a manner similar to that discussed herein, wherein the motor 72 may be actuated and cause rotation of the drive shaft 74, which may cause the drive magnet 76 to rotate in a manner that causes the driven magnet 78 and the impeller 67 to rotate in a desired direction and at a desired speed. The motor 72, drive shaft 74, and drive magnet 76 may be hermetically separated (e.g., fluidly isolated) from the driven magnet 78 coupled to (e.g., via the impeller shaft 66) the impeller 67.

[0055] like Figure 5As depicted, the impeller housing 60 can accommodate the magnetic assembly 73 and the impeller 67. In some cases, the impeller housing 60 may include a partition 64 (e.g., a wall and / or other suitable partition) that can hermetically seal the drive magnet 76 inside a first portion 60a of the impeller housing 60, while the driven magnet 78, coupled to the impeller 67 via the impeller shaft 66, can be positioned inside a second portion 60b of the impeller housing 60, through which blood can exit from its opening 62.

[0056] In some examples, the drive magnet 76 may be located separately from (independently formed) the impeller housing 60 and coupled to or connected to the impeller housing 60. When independently formed, the housing in which the drive magnet 76 is located may be coupled to the proximal end of the impeller housing 60 in any suitable manner, including but not limited to welding, brazing and / or other suitable techniques.

[0057] As discussed, the flexible elongated shaft 92 can be configured to directly or indirectly (e.g., via one or more components) connect the motor housing 70 to the impeller housing 60. Therefore, the central axis of the impeller housing 60 (which may also be the axis of rotation of the impeller 67) may not be parallel to the central axis of the motor housing 70 (which may also be the axis of rotation of the motor drive shaft 74). In some examples, the flexible elongated shaft 92 may include an elongated core member 94 (e.g., a flexible elongated core member 94) and an elongated outer shell 96 (e.g., a flexible elongated shell) extending along the elongated core member 94.

[0058] The flexible elongated shaft 92 can have any suitable length. Exemplary suitable lengths of the flexible elongated shaft 92 include, but are not limited to, lengths less than about 7 centimeters (cm), lengths in the range of about 5 cm to about 12 cm, lengths in the range of about 7 cm to about 10 cm, lengths greater than 10 cm, lengths greater than 12 cm, and / or other suitable lengths.

[0059] In some examples, the length of the flexible elongated shaft 92 may be a suitable distance to allow the impeller housing 60 to be positioned distal to the patient's aortic arch (e.g., in the left ventricle of the heart) and to allow the motor housing 70 to be positioned internally to the patient's vascular system and proximal to the aortic arch. In some examples, the length of the flexible elongated shaft 92 may be a suitable distance to allow the impeller housing 60 to be positioned distal to the patient's aortic arch and to allow the motor housing 70 to be positioned externally to the entry site into the patient. Other suitable length configurations of the flexible elongated shaft 92 may be considered such that the positioning of the motor housing 70 and the motor 72 relative to the impeller housing 60 can facilitate insertion of the blood pump 50 into the patient, tracking the blood pump 50 along the patient's blood vessels to a target site (e.g., the ventricle of the patient's heart and / or other suitable target sites), and / or operation of the blood pump 50.

[0060] An elongated core member 94 may extend between the motor 72 and the drive magnet 76 to transmit rotational motion from the motor 72 to the drive magnet 76. The elongated core member 94 may be an elongated, flexible configuration of the drive shaft 74, but other suitable configurations of the elongated core member 94 are also contemplated, as discussed herein and / or otherwise. In some example configurations, the elongated core member 94 may extend between and be coupled to the motor 72 and the drive magnet 76 to transmit motion from the motor 72 to the drive magnet 76 and drive the impeller 67 in response to actuation of the motor 72. The elongated core member 94 may be flexible such that the motor 72 and the motor housing 70 may be positioned at a non-parallel angle relative to the impeller housing 60, such that the axis of rotation of the impeller 67 within the impeller housing 60 is not parallel to the axis of rotation of the motor drive shaft 74 extending from the motor 72.

[0061] The elongated core member 94 may have a proximal portion that includes, is coupled to, or is connected to (e.g., communicates with) a motor drive shaft 74 at its proximal end 92a of the flexible elongated shaft 92. The motor drive shaft 74 may be a rigid shaft not intended to flex or bend during use, while the elongated core member 94 may be a flexible shaft intended to flex or bend during use. In some examples, the elongated core member 94 may be securely welded, brazed, or otherwise fixed to or together with the drive shaft 74, configured to withstand the rotational forces required to drive the impeller 67. Thus, rotation of the motor drive shaft 74 causes rotation of the elongated core member 94.

[0062] The elongated core member 94 may have a proximal portion that includes, is coupled to, or is connected to (e.g., communicates with) a magnetic component 73 at the distal end 92b of the flexible elongated shaft 92. The elongated core member 94 may be coupled to or connected to the magnetic component by welding, brazing, or other fixed connections configured to withstand the rotational forces required to drive the impeller 67.

[0063] In some configurations, the elongated core member 94 may include a rigid shaft 98 (e.g., a driven shaft) and / or be coupled to the rigid shaft 98, wherein the rigid shaft 98 (e.g., the distal end of the rigid shaft 98) may be coupled to or coupled to the drive magnet 76. Although the rigid shaft 98 may be part of the elongated core member 94 in some configurations (e.g., such that the elongated core member 94 includes a rigid portion (such as the rigid shaft 98) and a flexible portion proximal to the rigid shaft 98), in some configurations, the rigid shaft 98 may be part of the magnetic assembly 73, and the elongated core member 94 may be coupled to or coupled to the rigid shaft 98 (e.g., coupled to or coupled to the proximal end of the rigid shaft 98) (e.g., in communication with the rigid shaft 98). When coupled to or connected to the rigid shaft 98, the elongated core member 94 may be welded, brazed, or otherwise fixed to or relative to the proximal portion of the rigid shaft 98, and the distal portion of the rigid shaft 98 may be welded, brazed, or otherwise fixed to or relative to the drive magnet 76. However, in some examples, the rigid shaft 98 may be omitted. When the rigid shaft 98 is included, it may be configured to ensure that rotation of the elongated core member 94 at its distal end 92b is axially aligned with the rotational movement of the drive magnet 76 and / or the impeller 67.

[0064] The elongated core member 94 can be formed of any suitable type of material. Exemplary suitable types of materials include, but are not limited to, metals, polymers, stainless steel, nickel-titanium alloys (Nitinol), polyetheretherketone (PEEK), and / or other suitable materials. In some configurations (e.g., when the elongated core member 94 is formed of a metallic material, etc.), the elongated core member 94 may include a thin floating sleeve configured to facilitate the containment of lubricant along the elongated core member 94, wherein the thin sleeve may be formed of a polymer (polyurethane, polyethylene terephthalate (PET), etc.).

[0065] The elongated core member 94 can be formed from a single component or multiple components. In some examples, the core member 94 can be a single strand of stainless steel or nickel-titanium alloy. Alternatively, in some examples, the core member 94 can comprise multiple elongated coils, wires, and / or windings of stainless steel, nickel-titanium alloy, and / or other suitable materials. Other suitable configurations of the elongated core member 94 may be considered.

[0066] The flexible elongated shaft 92 may include an elongated coating or housing 96 (e.g., a flexible elongated coating or housing) extending over at least a portion of the length of the elongated core member 94 and / or along at least a portion of the length of the elongated core member 94. The elongated housing 96 may extend on the elongated core member 94 to isolate the elongated core member 94 from fluids (e.g., blood, etc.) within the patient's body, prevent the rotating elongated core member 94 from engaging with patient tissue, and / or maintain lubrication around the elongated core member 94.

[0067] The elongated housing 96 can have any suitable outer diameter. In some examples, the first outer diameter D1 of the elongated housing 96 of the flexible elongated shaft 92 can be smaller than the second outer diameter D2 of the impeller housing 60, the first outer diameter D1 can be smaller than the third outer diameter D3 of the motor housing 70, or the first outer diameter D1 can be smaller than both the second and third outer diameters D2 and D3. In one example, the first outer diameter D1 can be nine (9) French (e.g., about three (3) millimeters (mm)). Other suitable configurations may be considered.

[0068] The elongated housing 96 can be formed of any suitable material. Exemplary suitable materials include, but are not limited to, metals, polymers, polyurethanes, PET, and / or other suitable materials. In some examples, the elongated housing 96 may be a polymer tube or sleeve applied over the elongated core member 94. In some examples, the elongated housing 96 may be a polymer reflow along the material of the elongated core member 94. Other suitable configurations of the elongated housing 96 may be contemplated.

[0069] The elongated housing 96 may include and / or be coupled to a proximal cover 97 and a distal cover 99. The proximal cover 97 and / or the distal cover 99 may extend longitudinally and / or radially outward from the elongated housing 96 and connect the elongated housing 96 to the motor housing 70, the impeller housing 60, and / or other suitable components of the blood pump 50. To reduce scratching on tissues and / or otherwise facilitate insertion and / or passage of the blood pump 50 into and / or through a patient's blood vessels, the outer diameter of the proximal cover 97 may decrease radially inward as the proximal cover 97 extends distally, and the outer diameter of the distal cover 99 may expand radially outward as the distal cover 99 extends distally. In some cases, the proximal cap 97 and / or the distal cap 99 can help connect the elongated housing 96 to the motor housing 70 and the impeller housing 60 to provide a hermetically sealed isolation of the blood pump's drive components (e.g., motor 72, drive shaft 74, elongated core member 94, drive magnet 76, and / or other suitable components) from the fluid within the patient's body. Furthermore, hermetically sealing the drive components can help maintain lubrication around them during operation.

[0070] The proximal cover 97 and / or distal cover 99 may be formed of the same or different materials as the material forming the elongated housing 96. In some examples, the proximal cover 97 and / or distal cover 99 may be formed of metallic materials, polymeric materials, stainless steel, nickel-based superalloys, INCONEL, nickel-titanium alloys, nickel-titanium alloys, nickel-cobalt alloys, MP35N, and / or other suitable materials. In one example, the proximal cover 97 and distal cover 99 may be formed of stainless steel and joined to the polymeric material of the elongated housing 96 using a polymer reflow process, but other suitable constructions are also contemplated. When the proximal cover 97 and distal cover 99 are formed of one or more metallic materials, the proximal cover 97 may be joined to the motor housing 70 by solder or weld connection, and the distal cover 99 may be joined to the impeller housing 60 or other components by solder or weld connection.

[0071] One or more bearing assemblies 82 can be any suitable type of bearing assembly. For example, bearing assembly 82 can be a radial bearing assembly, a thrust bearing assembly, a radial and thrust bearing assembly, an oil-embedded sleeve / flange bearing assembly, and / or one or more other suitable types of bearing assemblies. Figure 5 As schematically depicted, bearing assembly 82 may at least include ball bearing 84 and bearing cage 86, but additional or alternative components may also be used. Furthermore, bearing assembly 82 may include housing 88 (e.g., bearing housing) for receiving ball bearing 84, bearing cage 86, and / or other suitable components of bearing assembly 82. Although in Figure 5Not depicted, but bearing assembly 82 may include an inner ring configured to extend between elongated core member 94 and ball bearing 84. When an inner ring is included, it may be independent of or part of bearing cage 86.

[0072] The bearing assembly 82 can be formed of any suitable material. For example, the ball bearing 84, the bearing cage 86, the housing 88 and / or other suitable components of the bearing assembly 82 (if any) can be formed of metallic materials, ceramic materials, stainless steel materials and / or one or more other suitable materials.

[0073] The bearing assembly 82 can be coupled to the distal end 92b of the flexible elongated shaft 92 (e.g., via the elongated core member 94 and / or the distal end cap 99) and the impeller housing 60. In some examples, the bearing assembly 82 may be part of, contained within, or accommodated by the impeller housing 60 and / or the distal end cap 99. When the distal end cap 99 is formed of a metallic material and the impeller housing 60 is formed of a metallic material, the bearing assembly 82 may be coupled to the distal end cap 99 and / or the impeller housing 60 using welded, solder-jointed, press-fitted, laser-welded, and / or other suitable types of connections. When one or more of the distal end cap 99 and the impeller housing 60 are formed of a polymeric material, reflow or other suitable polymeric joining techniques may be used to couple the bearing assembly 82 to the impeller housing 60 and / or the distal end cap 99. In one example configuration, the bearing assembly 82 may be a pressure-bearing component positioned within the impeller housing 60 and the distal cover 99, wherein the distal cover 99, the impeller housing 60, the housing 88 of the bearing assembly 82, and / or the bearing cage 86 may be welded together (e.g., at the joint between the proximal end of the impeller housing 60 and the distal cover 99). Other suitable joining techniques may be considered.

[0074] The bearing assembly 82 may be coupled to the proximal end of the impeller housing 60, or otherwise located within the impeller housing 60, proximal to the drive magnet 76. The bearing assembly 82 may be located distal to the joint or connection between the flexible elongated core member 94 and the rigid shaft 98, wherein the rigid shaft 98 extends through the bearing assembly 82. In some cases, the bearing assembly 82 may include proximal and distal openings, such that the rigid shaft 98 (e.g., the distal portion of the elongated core member 94 and / or other suitable portion) can extend through the bearing assembly 82 to reach the drive magnet 76 to which the elongated core member 94 is fixed or coupled. As the rigid shaft 98 passes through the bearing assembly 82, the rigid shaft 98 may engage the inner surface of the bearing assembly 82 to allow rotation of the rigid shaft 98 about an axis aligned with the axis of rotation extending through the drive magnet 76, the driven magnet 78, the impeller shaft 66, and / or the impeller 67.

[0075] Figure 6 schematically depicted Figure 5 The portion of the transdermal circulation support device 10 depicted in the image has a bend formed in the flexible slender shaft 92. Although Figure 6 The image depicts a single bend along the flexible slender shaft 92, but one or more bends may be formed along the flexible slender shaft 92 as needed. When the flexible slender shaft 92 bends or flexes, the central axis of the impeller housing 60 (which may also be the axis of rotation of the impeller 67) may not be parallel to the central axis of the motor housing 70 (which may also be the axis of rotation of the motor drive shaft 74).

[0076] Figure 7 A portion of the blood pump 50 of the transdermal circulation support device 10 is schematically depicted, wherein an elongated core member 94 may be formed of a single material and extend through a bearing assembly 82. In some examples, the single material of the elongated core member 94 may be a polymeric material, a metallic material, and / or one or more other suitable materials. In one example, the single material of the elongated core member 94 may be a flexible polymer or a metallic material, and the bearing assembly 82 may help ensure that the elongated core member 94 rotates about an axis aligned with the axes of the magnetic assembly 73, the impeller shaft 66, and the impeller 67 at a location near the drive magnet 76.

[0077] When the elongated core member 94 is formed of a polymeric material, the elongated core member 94 may be formed of a first polymer, and the elongated outer shell 96 may be formed of a second polymer, which may be the same as or different from the first polymer. In one example, the first polymer may be PEEK and / or other suitable materials, and the second polymer may be polyurethane, PET, and / or other suitable materials, but other suitable configurations are also contemplated. In some examples, a lubricant may be used between the elongated core member 94 (e.g., a metal or polymer elongated core member) and the elongated outer shell 96 to minimize wear on the elongated core member 94 as it rotates in response to the actuation of the motor 72.

[0078] Figure 8 A portion of the blood pump 50 of the transdermal circulation support device 10 is schematically depicted, wherein the blood pump 50 may include multiple bearing assemblies 82. Figure 8 As depicted, the blood pump 50 may include two bearing assemblies 82, but other suitable numbers of bearing assemblies 82 may also be utilized. Although Figure 8The two bearing assemblies 82 are depicted extending along the rigid shaft 98, but it is also possible for a flexible, elongated core member 94 to extend through the bearing assembly 82. In some examples, utilizing multiple bearing assemblies 82 and / or axially elongated bearing assemblies 82 can help achieve the desired runtime durability because multiple bearing assemblies 82 and / or elongated bearing assemblies 82 maintain the stability of the rotating components of the blood pump 50 by centering the drive magnet 76 within the impeller housing 60 and reducing contact between the drive magnet 76 and the inner wall of the impeller housing 60 during surgery and / or at other times when the flexible, elongated shaft 92 bends.

[0079] Two or more bearing assemblies 82 may be positioned close to each other and / or spaced apart from each other or at least spaced apart from one other bearing assembly 82 in order to hold the drive magnet 76 in a central position within the impeller housing 60 or other suitable housing. Figure 8 As depicted, the two bearing assemblies 82 can be positioned close to each other and axially aligned with each other. Alternatively, the two bearing assemblies can be spaced apart from each other (e.g., axially spaced) and axially aligned with each other.

[0080] As discussed, bearing assembly 82 may include ball bearings 84, bearing cages 86, and / or housings 88. In some examples, when multiple bearing assemblies 82 are close to each other, each bearing assembly 82 may include ball bearings 84, bearing cages 86, and housings 88. Alternatively, in some examples, when multiple bearing assemblies 82 are close to each other, bearing assembly 82 may share one or more components with one or more other bearing assemblies 82. In one example, the first bearing assembly 82 and the second bearing assembly 82 may have separate ball bearings 84 but share a single bearing cage 86 and / or housing 88. In one example, the first bearing assembly 82 and the second bearing assembly 82 may share one or more ball bearings 84 and have separate or shared bearing cages 86 and / or housings 88. In addition to having multiple bearing assemblies 82 or as an alternative, one or more bearing assemblies 82 may have elongated members that extend along the axial length of a rigid shaft 98 or a flexible elongated core member 94 greater than the axial length of a single standard bearing assembly 82 (e.g., in...). Figure 5 The distance can be depicted in the case of a single standard bearing.

[0081] Multiple bearing assemblies 82 may be coupled to each other, to the distal end 92b of a flexible elongated shaft 92 (e.g., via an elongated core member 94 and / or a distal end cap 99), and / or to an impeller housing 60. In some examples, the multiple bearing assemblies 82 may be part of, or housed within, or contained within, the impeller housing 60 and / or the distal end cap 99. When the housing 88 of the bearing assembly 82 is formed of a metallic material, the distal end cap 99 is formed of a metallic material, and / or the impeller housing 60 is formed of a metallic material, the bearing assemblies 82 may be coupled to each other, to the distal end cap 99, and / or to the impeller housing 60 using welded connections, solder connections, press-fit connections, laser-welded connections, and / or other suitable types of connections. When one or more of the housing 88, distal end cap 99, and impeller housing 60 of bearing assembly 82 are formed of a polymer material, polymer bonding techniques for the return or other suitable housing 88 can be used to bond bearing assemblies 82 to each other, to the impeller housing 60, and / or to the distal end cap 99. In one example configuration, bearing assembly 82 can be positioned as a pressure-bearing component within the impeller housing 60 and distal end cap 99, wherein the distal end cap 99, impeller housing 60, housing 88 of bearing assembly 82, and / or bearing cage 86 can be welded together. Other suitable bonding techniques may be considered.

[0082] It should be understood that this disclosure is merely illustrative in many respects. Changes in detail may be made, particularly in terms of shape, size, and arrangement of steps, without departing from the scope of this disclosure. To the appropriate extent, this may include the use of any feature of an example construction used in other constructions. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A blood pump, comprising: Impeller casing; An impeller disposed in the impeller housing; Magnetic components connected to the impeller; Motor housing; A motor disposed in the motor housing, wherein the motor is in communication with the magnetic assembly to drive the impeller; as well as A flexible, slender shaft is connected to the magnetic assembly and the motor housing, and The flexible slender shaft has a first outer diameter that is smaller than the second outer diameter of the impeller housing.

2. The blood pump of claim 1, wherein the motor housing has a third outer diameter, and the first outer diameter is smaller than the third outer diameter.

3. The blood pump of claim 1 or 2, wherein the flexible elongated shaft has an elongated core member and an elongated outer shell extending along the elongated core member.

4. The blood pump of claim 3, further comprising: Motor drives the shaft, and The elongated core member has a proximal portion communicating with the motor drive shaft and a distal portion communicating with the magnetic component.

5. The blood pump of claim 3, wherein the magnetic component includes a driven shaft, and the elongated core member has a distal portion communicating with the driven shaft.

6. The blood pump as claimed in any of the preceding claims, wherein the magnetic component is located in the impeller housing.

7. The blood pump as claimed in any of the preceding claims, wherein the magnetic component comprises: A driven magnet connected to the impeller; as well as A driving magnet, which is fluidly isolated from the driven magnet and is configured to drive the driven magnet.

8. The blood pump of claim 7, wherein the driven magnet is located in the impeller housing.

9. The blood pump of claim 7, further comprising: The driven shaft has a proximal portion connected to the flexible elongated shaft and a distal portion connected to the driving magnet.

10. The blood pump according to any one of the preceding claims, further comprising: A bearing assembly connected to the impeller housing and the flexible slender shaft.

11. A blood pump comprising: Impeller casing; An impeller disposed in the impeller housing; The bearing assembly connected to the impeller housing; Motor housing; The motor is installed in the motor housing; as well as A flexible slender shaft having a proximal portion connected to the motor housing and a distal portion connected to the bearing assembly.

12. The blood pump of claim 11, wherein the flexible elongated shaft has an elongated core member and an elongated housing extending along the elongated core member, the elongated housing being coupled to the bearing assembly.

13. The blood pump of claim 12, further comprising: Motor drive shaft, The elongated core member has a proximal portion that communicates with the motor drive shaft; and The elongated core member extends through the bearing assembly.

14. The blood pump of claim 11, further comprising: A magnetic assembly coupled to the distal portion of the flexible elongated shaft, wherein the magnetic assembly includes: A driven magnet connected to the impeller; as well as A driving magnet, which is fluidly isolated from the driven magnet and coupled to the distal portion of the flexible elongated shaft, drives the driven magnet in response to actuation of the motor; The magnetic component is configured to drive the impeller in response to actuation of the motor; The flexible elongated shaft has an elongated core member having a distal portion extending through the bearing assembly and connected to the drive magnet; The elongated core member comprises a flexible portion and a rigid portion, wherein the rigid portion extends through the bearing assembly and is coupled to the drive magnet.

15. A blood pump comprising: Impeller casing; An impeller disposed in the impeller housing; A bearing assembly connected to the proximal end of the impeller housing; Motor housing; The motor is installed in the motor housing; as well as A flexible, slender shaft having a proximal portion connected to the motor housing and a distal portion connected to the bearing assembly, and The flexible slender shaft has a first outer diameter between the motor housing and the bearing assembly, and the impeller housing has a second outer diameter larger than the first outer diameter.

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