Medical device

Abstract

To provide an alternative medical device.SOLUTION: A medical device includes a housing, a fluid barrier, an impeller, a first magnet, a driving shaft, and a second magnet. The housing includes at least one each of an inlet for a blood flow and an outlet for a blood flow, and has a longitudinal axis. The fluid barrier is arranged in the housing, separates the housing into a first section including the inlet and the outlet, and a second section, and is impervious to fluid. The impeller is arranged in the first section. The longitudinal axis of the impeller is identical to the longitudinal axis of the housing. The impeller includes a body and a blade extending outwardly to the outside in the radial direction from the body. The first magnet is joined to the impeller shaft, and is arranged in the first section. The driving shaft is arranged in the second section. The second magnet is arranged in the second section. The rotation of the second magnet rotates the first magnet. The proximal end of the impeller shaft extends proximal of the first magnet.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] The present invention relates to a medical device, and more particularly, to a blood flow assist device including an implantable rotary blood pump for assisting the heart in driving blood flow, and a method of using such a medical device.

Background Art

[0002] A wide variety of medical devices have been developed for medical use, including medical devices that are used, for example, to assist the heart in pumping blood throughout the circulatory system. These medical devices can be implanted temporarily or permanently and are manufactured and used according to any of a variety of different methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There continues to be a need to provide alternative medical devices, as well as alternative methods for manufacturing and using medical devices.

Summary of the Invention

[0003] The present invention provides designs, materials, manufacturing methods, and uses for alternative medical devices. An exemplary medical device includes a housing that includes at least one inlet for receiving blood flow and at least one outlet for delivering blood flow, the housing having a longitudinal axis, and includes a fluid barrier disposed within the housing that separates the housing into a first section including at least one inlet and at least one outlet and a second section, the fluid barrier being impermeable to fluids, and includes an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outward from the body, and includes at least one first magnet coupled to an impeller shaft, the impeller shaft being coupled to the impeller, the first magnet being disposed within the first section of the housing and rotatably coupled to the impeller shaft, and includes a drive shaft disposed within the second section of the housing, and includes at least one second magnet disposed on the drive shaft within the second section of the housing, the first magnet and the second magnet being configured and arranged such that rotation of the second magnet causes the first magnet to rotate.

[0004] Alternatively or additionally to any of the above-described embodiments, the medical device further includes a power source coupled to the drive shaft. Alternatively or additionally to any of the above-described embodiments, the power source is disposed within a catheter shaft attached to the second section of the housing.

[0005] Alternatively or additionally to any of the above-described embodiments, the power source is a motor. Alternatively or additionally to any of the above-described embodiments, the power source is a second impeller connected to the drive shaft, the catheter shaft defines a fluid flow path, and the drive shaft and the second impeller are arranged in the fluid flow path such that the fluid impinging on the second impeller drives the impeller, thereby rotating the second magnet to rotate the first magnet and rotate the impeller shaft and the impeller.

[0006] Alternatively or additionally to any of the above-described embodiments, at least one outlet includes a plurality of side openings spaced around the housing, and the impeller is arranged within the housing such that at least one blade is arranged adjacent to the plurality of side openings.

[0007] Alternatively or additionally to any of the above-described embodiments, the first magnet has a first opening that opens thereto, the first opening is configured to receive the impeller shaft and couple to the first magnet, the second magnet has a second opening that opens thereto, the second opening is configured to receive the drive shaft and couple to the second magnet, the first opening and the second opening each have a first cross-sectional shape that is orthogonal to the longitudinal axis of the drive shaft, the drive shaft and at least a portion of the impeller shaft each have a second cross-sectional shape that is orthogonal to the longitudinal axis of the respective shaft, and the first cross-sectional shape and the second cross-sectional shape are non-circular such that the first magnet and the second magnet rotate with the rotation of the impeller shaft and the drive shaft, respectively.

[0008] Alternatively or additionally to any of the above-described embodiments, the first and second cross-sectional shapes are stadium-shaped having straight sides and semi-circular ends. Alternatively or additionally to any of the above-described embodiments, the distal region of the impeller shaft is cylindrical.

[0009] Alternatively or additionally to any of the above-described embodiments, the proximal end of the impeller shaft extends proximally to the first magnet and has a first protrusion configured to be received by a first recess of the fluid barrier.

[0010] Alternatively or additionally to any of the above-described embodiments, the impeller shaft includes a disk adjacent to the first protrusion, and the disk extends perpendicular to the longitudinal axis of the impeller shaft.

[0011] Alternatively or additionally to any of the above-described embodiments, the disk has two opposing lobes. Alternatively or additionally to any of the above-described embodiments, the medical device further includes a pivot member disposed between the second magnet and the fluid barrier.

[0012] Alternatively or additionally to any of the above-described embodiments, the pivot member has a protrusion extending distally from the pivot member, and the protrusion is configured to be received by a second recess of the fluid barrier.

[0013] Alternatively or additionally to any of the above-described embodiments, the medical device further includes a bearing assembly configured to support and center the distal end of the impeller shaft, and the bearing assembly includes a bearing housing fixed to the housing, a spacer slidably disposed within the bearing housing, and a distal bearing fixed within the spacer.

[0014] Alternatively or additionally to any of the above-described embodiments, the bearing assembly further includes a spring member disposed around the spacer. Another exemplary medical device includes a housing that includes an inlet for receiving blood flow and a plurality of side openings for delivering blood flow, the housing having a longitudinal axis, and including a fluid barrier disposed within the housing that separates the housing into a first section that includes the inlet and the plurality of side openings and a second section, the fluid barrier being impermeable to fluid, and including an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outward from the body, and including at least one first magnet disposed within the first section of the housing and coupled to the impeller to rotate the impeller by rotation, and including a drive shaft disposed within the second section of the housing, and including at least one second magnet coupled to the drive shaft and disposed within the second section of the housing, the first magnet and the second magnet being configured and arranged such that rotation of the second magnet causes rotation of the first magnet, and including a catheter shaft coupled to the housing, and including a power source coupled to the drive shaft, the power source being disposed within the catheter shaft.

[0015] Alternatively or additionally to any of the above-described embodiments, the power source is a second impeller connected to the drive shaft, the catheter shaft defines a fluid flow path, and the drive shaft and the second impeller are disposed within the fluid flow path such that fluid impinging on the second impeller drives the impeller, thereby rotating the second magnet to rotate the first magnet and rotate the impeller.

[0016] Alternatively or additionally to any of the above-described embodiments, the medical device further includes an impeller shaft disposed and coupled to the impeller and the first magnet, and a bearing assembly configured to support and center the distal end of the impeller shaft, the bearing assembly including a bearing housing fixed to the housing, a spacer slidably disposed within the bearing housing, and a distal bearing fixed within the spacer.

[0017] A method for assisting blood flow from a patient's heart to the patient's circulatory system includes inserting a device into the ascending aorta, the device including a housing having at least one inlet for receiving blood flow from the left ventricle of the heart and at least one outlet for delivering blood flow to the ascending aorta, the housing having a longitudinal axis and including a fluid barrier disposed within the housing that separates the housing into a first section including at least one inlet and at least one outlet and a second section, the fluid barrier being impermeable to blood and including an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outward from the body and including an impeller shaft disposed within and coupled to the impeller, including at least one first magnet having a first opening for receiving the impeller shaft, the first magnet being disposed in the first section of the housing and rotatably coupled to the impeller shaft, including a drive shaft disposed within the second section of the housing, including at least one second magnet disposed on the drive shaft within the second section of the housing, the first magnet and the second magnet being configured and arranged such that rotation of the second magnet causes rotation of the first magnet. The method further includes rotating the drive shaft, thereby rotating the second magnet, thereby rotating the first magnet, thereby rotating the impeller shaft and the impeller, generating suction, thereby drawing blood into the housing through at least one inlet from the left ventricle, and delivering blood to the ascending aorta from at least one outlet.

[0018] The above summaries of some embodiments, aspects, and / or examples are not intended to describe every embodiment or all implementations of the present invention. The following figures and detailed description illustrate these embodiments more specifically.

[0019] The present invention can be more fully understood in view of the following detailed description of various embodiments in connection with the accompanying drawings.

Brief Description of the Drawings

[0020]

Figure 1

Figure 2

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Figure 4

Figure 5

Figure 6

Figure 7A

Figure 7B

Figure 8

Figure 9A

Figure 9B

Figure 9C

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Best Mode for Carrying Out the Invention

[0021] While various modifications and alternative forms of the present invention are possible, the details are shown by way of example in the drawings and will be described in detail. However, it should be understood that the intention is not to limit the aspects of the present invention to the specific embodiments described. On the contrary, the intention is to cover all improvements, equivalents, and alternatives included within the spirit and scope of the present invention.

[0022] The following defined terms apply unless a different definition is given in the claims or elsewhere in this specification. In this specification, all numerical values are assumed to be modified by the term "about" whether explicitly indicated or not. The term "about" generally refers to a range of numerical values that a person skilled in the art would consider equivalent (e.g., having the same function or result) in the context of the numerical value. In many cases, the term "about" may include numerical values rounded to the nearest significant digit. Other uses of the term "about" (e.g., in contexts other than numerical values) are understood from the context of the specification and are considered to have their normal customary definitions consistent therewith unless otherwise specified.

[0023] The recitation of numerical ranges by endpoints includes all numerical values within that range including the endpoints (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5). Although some appropriate dimensions, ranges, and / or values for various components, features, and / or specifications are disclosed, those skilled in the art induced by this specification will understand that the desired dimensions, ranges, and / or values may deviate from those explicitly disclosed.

[0024] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the context clearly dictates otherwise. It should be noted that for ease of understanding, given features of the disclosure, even if they are in plural form or repeated within the disclosed embodiments, those features may be described in singular form. Unless otherwise specified, each instance of a feature may be included and / or encompassed by a single disclosure. For purposes of simplification and clarity, not all elements of the disclosure are necessarily shown in each figure or described in detail below. However, it will be understood that the following description may be equally applicable to any and / or all of the plurality of components unless explicitly stated to the contrary. Additionally, for purposes of clarity, not all instances of some components or features are shown in each figure.

[0025] Relative terms such as "proximal", "distal", "advancing", "retreating", and variations thereof are generally considered in relation to the placement, orientation, and / or operation of various components relative to a user, operator, or operator of the device. "Proximal" and "retreating" are taken to represent or mean close to or towards the user, and "distal" and "advancing" are taken to mean away from or receding from the user. In some cases, the terms "proximal" and "distal" may be arbitrarily assigned for ease of understanding of the disclosure, and in such cases it will be readily apparent to those skilled in the art. Other relative terms such as "upstream", "downstream", "inflow", and "outflow" refer to the direction of fluid flow within a lumen such as a body lumen, within a blood vessel, or within a device.

[0026] The term "range" should be understood to mean the maximum dimension of the recited or identified size, unless the range or size in question is modified or identified by "minimum" which can be understood to mean the smallest dimension of the recited or identified size. For example, an "outer range" can be understood to mean the maximum outer dimension, a "radius range" can be understood to mean the maximum radius dimension, a "longitudinal range" can be understood to mean the maximum longitudinal dimension, and so on. Each instance of "range" may be different (e.g., axial, longitudinal, transverse, radial, circumferential, etc.) and will be apparent to those skilled in the art from the context of the individual usage. Generally, a "range" can be considered to be the largest size that can be measured in accordance with the intended usage, while the "minimum range" is the smallest size that can be measured in accordance with the intended usage. In some cases, a "range" can generally be measured at right angles within a plane and / or cross-section, but in a particular context, it can be measured in different ways, for example, but not limited to, angled, radial, circumferential (e.g., along an arc), etc.

[0027] The terms "monolithic" and "unitary" generally refer to components or a plurality of components made from or consisting of a single structure or base unit / base element. Monolithic elements and / or unitary elements exclude structures and / or mechanisms by assembly, or otherwise, those that are a combination of a plurality of separate and independent elements joined together.

[0028] References to "one embodiment", "some embodiments", "other embodiments", etc. in this specification indicate that the described embodiments may include certain features, structures, or characteristics, but not all embodiments necessarily include the specific features, structures, or characteristics. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a specific feature, structure, or characteristic is described in relation to an embodiment, it is within the knowledge of those skilled in the art to affect the specific feature, structure, or characteristic in relation to other embodiments, whether explicitly described or not, unless the contrary is clearly stated. That is, the various individual elements described below, even if not explicitly shown in a particular combination, are assumed to be combinable or arrangeable with each other to form other additional embodiments or to complement and / or enhance the described embodiments as understood by those skilled in the art.

[0029] For purposes of clarity, a given numerical naming for identification (e.g., first, second, third, fourth, etc.) may be used throughout the specification and / or claims to name and / or distinguish the variously described and / or claimed features. It should be understood that the numerical naming is not intended to be limiting and is merely illustrative. In some embodiments, substitutions and departures from previously used numerical naming conventions may be made for the sake of brevity and clarity. That is, a feature identified as the "first" element may later be referred to as the "second" element, the "third" element, etc., or may be completely omitted, and / or a different feature may be referred to as the "first" element. The meaning and / or indication in each example will be apparent to a skilled practitioner.

[0030] The following description should be read with reference to the drawings which are not necessarily to scale, and like elements in different drawings are numbered the same. The detailed description and the drawings are intended to illustrate the disclosure and not to limit it. Those skilled in the art will recognize that the various elements described and / or shown can be arranged in various combinations and configurations without departing from the scope of the invention. The detailed description and the drawings show exemplary embodiments of the invention. However, for clarity and ease of understanding, not all features or elements may be shown in each drawing, but unless otherwise specified, features and elements can be understood to be present.

[0031] As will be described in more detail below, FIG. 1 shows a partial cross-sectional view of an exemplary power transmission mechanism that can be utilized within a blood flow assist device. Specifically, FIG. 1 shows how magnetic forces transmitted through a blood-impermeable barrier are used to drive an impeller for assisting blood flow through a blood vessel. In this figure, device 10 is disposed within blood vessel 5. Device 10 may include a housing 20 separated by a fluid barrier 35 that is impermeable to blood into a distal first section 21 and a proximal second section 22. In some examples, fluid barrier 35 can be made of ultra-high molecular weight polyethylene (UHMWPE), polyoxymethylene such as Delrin® acetal homopolymer resin, polyetheretherketone (PEEK), nylon, high-density polyethylene (HDPE), other polymers commonly used in medical devices, sapphire, ruby, nickel-cobalt-based alloys such as MP35N®, cobalt-chromium alloys, titanium, titanium alloys, etc. In other examples, fluid barrier 35 may be filled with fibers or impregnated with oil. Fluid barrier 35 may extend across the interior of housing 20 and provide a complete seal against blood leakage into second section 22 when first section 21 is filled with blood. Device 10 may further include a first magnet 40 disposed in the first section 21 of housing 20 and coupled to impeller shaft 50 and impeller 60. First magnet 40 may be coupled to impeller shaft 50 by a physical structure such as an opening in first magnet 40 that receives impeller shaft 50. Alternatively, first magnet 40 may have a protrusion that is received within a recess in impeller shaft 50. The opening / recess may be keyed to the shaft / protrusion to couple the magnet and the shaft. For example, the opening / recess may have a shape that conforms to the shape of the shaft / protrusion. In other examples, first magnet 40 may be coupled to impeller shaft 50 by welding, sintering, adhesive bonding, etc. The device may include one or more bearings 70 that surround or support the impeller shaft.

[0032] In the second section 22 of the housing 20, the second magnet 42 can be coupled to a drive shaft 90 that can be coupled to a power source 95. The second magnet 42 can be coupled to the drive shaft 90 as described above with respect to the first magnet 40 and the impeller shaft 50. One or more bearings 70 can surround the drive shaft 90. In some examples, the power source 95 can be an electric motor with a power cord 97 that extends proximally through the housing 20, passing outside the body and through a catheter (not shown) connected to the housing.

[0033] In the example shown in FIG. 1, the first and second magnets 40, 42 are bipolar magnets, and the N pole N of the first magnet 40 is arranged with the fluid barrier 35 interposed therebetween from the S pole S of the second magnet 42, and the S pole S of the first magnet 40 is arranged with the fluid barrier 35 interposed therebetween from the N pole N of the second magnet 42. This orientation of the first and second magnets 40, 42 ensures that the attractive force between the magnets indicated by the arrow 99 couples the rotational movement of the second magnet 42 to the rotational movement of the first magnet 40. The magnetic force is transmitted through the fluid barrier 35. It will be understood that magnets having more than two poles can be used. In use, the power source 95 rotates the drive shaft 90, thereby rotating the second magnet 42, and thereby rotating the first magnet 40 at the same speed as the second magnet 42. The rotation of the first magnet 40 rotates the attached impeller shaft 50, which rotates the attached impeller 60. Since the impeller 60 is in fluid contact with the blood in the blood vessel 5, the rotation of the impeller 60 assists the blood flow through the blood vessel 5. The fluid barrier 35 prevents leakage of blood into the second section 22 of the housing 20, and thus prevents contact of the blood with the drive shaft 90 and the power source 95.

[0034] In addition, it is possible to use a plurality of magnets on either side of the fluid barrier 35. Regardless of the number and / or type of magnets used, one or more magnets are configured and arranged such that the rotation of one or more magnets connected to the drive shaft 90 and the power source 95 rotates one or more magnets connected to the impeller 60.

[0035] Figure 2 illustrates another exemplary power transmission mechanism that can be utilized within a blood flow assistance device. Specifically, Figure 2 shows a method of assisting blood flow through a blood vessel using magnetic forces transmitted through a blood-impermeable barrier. The device shown in Figure 2 is similar to the device shown in Figure 1, but includes a fluid as a power source. The fluid source is provided under pressure or under vacuum, and it will be understood that the fluid flows as a high-pressure flow or a low-pressure flow. One end of the drive shaft 90 can be connected to a second magnet 42, and a second end of the drive shaft 90 can be connected to a second impeller 65. Both the second section 22 of the housing 20 and a catheter (not shown) connected to the housing 20 can include an inner lumen 24 and an outer lumen 26. As indicated by arrow 25, a high-pressure or low-pressure fluid, such as saline or other suitable fluid, can be injected through the inner lumen 24 towards the second impeller 65. The high-pressure or low-pressure fluid rotates the second impeller 65, and the second impeller 65 rotates the drive shaft 90 and the attached second magnet 42. As in the case of the first example in Figure 1, the rotation of the second magnet rotates the first magnet 40, thereby rotating the impeller shaft 50 and the impeller 60. The impeller 60 is in contact with the blood within the blood vessel 5, and thus the rotation of the impeller 60 assists the blood flow through the blood vessel 5. After rotating the second impeller 65, as indicated by arrow 27, the high-pressure or low-pressure fluid then returns through the outer lumen 26. The fluid barrier 35 prevents the fluid from entering the blood vessel 5. Similarly, the fluid barrier 35 prevents blood from entering the second section 22 and mixing with the fluid. The high-pressure or low-pressure fluid may be provided from a pressurized source or a vacuum source outside the body, and the return fluid can be collected and reused outside the body.

[0036] Figure 3 illustrates another exemplary power transmission mechanism that can be utilized within a blood flow assist device. The device shown in Figure 3 is similar to that shown in Figure 2, except that the direction of the fluid is reversed. Specifically, Figure 3 shows how high-pressure or low-pressure fluid can be injected through the outer lumen 26 towards the second impeller 65, as indicated by arrow 28. The high-pressure or low-pressure fluid rotates the second impeller 65, which rotates the drive shaft 90 and the attached second magnet 42. As in the case of the first example figure in Figure 1, the rotation of the second magnet rotates the first magnet 40, thereby rotating the impeller shaft 50 and the impeller 60. The impeller 60 is in contact with the blood within the blood vessel 5, and thus, the rotation of the impeller 60 assists the blood flow through the blood vessel 5. After rotating the second impeller 65, the high-pressure or low-pressure fluid then returns through the inner lumen 24, as indicated by arrow 29. The fluid barrier 35 prevents the fluid from entering the blood vessel 5. Similarly, the fluid barrier 35 prevents blood from entering the second section 22 and mixing with the fluid. The high-pressure or low-pressure fluid may be provided from an external source, and the return fluid can be collected and reused outside the body. The fluid source can be under pressure or under vacuum.

[0037] Figure 4 shows an exemplary device 110 including a power transmission mechanism disposed within a patient's heart 1. As shown in Figure 4, the device 110 is connected to a catheter shaft 115, and the distal end 128 of the device 110 can be disposed in the ascending aorta 4 adjacent to the aortic valve 3. Blood exiting the left ventricle 2 (indicated by arrow 8) enters the distal end 128 of the device 110, whereby the device 110 pumps the blood such that it exits through the side opening 130 of the device 110 with the additional force provided only by the left ventricle 2 (the blood exiting the device 110 is indicated by arrow 9), and thus this location can be beneficial. It can be understood that the additional pumping operation of the device 110 can assist the heart 1 in circulating blood throughout the body. Alternatively, the device 110 can be disposed such that it passes through the aortic valve 3 with the distal end 128 of the device 110 within the left ventricle 2 and the side opening 130 within the ascending aorta 4. In a further example, the device 110 can be disposed such that the side opening 130 is in the descending aorta. It is not intended to limit the size of the device 110 relative to the size of the heart chamber and aorta, and it is also understood that the size of the device 110 can be changed to provide the desired blood flow assistance. The catheter shaft 115 connected to the device 110 can extend outside the body through the vasculature. The catheter shaft 115 can include a power cord connected to an external power source. Although the device 110 can include a power source or the power source can be provided inside the patient, it is also envisioned that the power source is separate from the device 110 such as an internal pacemaker.

[0038] The above description explains the advantages of using the device 110 in the ascending aorta of the heart, but the device 110 is also envisioned to be used in other parts of the heart or other parts of the body (e.g., other body lumens). In some examples, the device 110 can be inserted into the patient with the housing disposed in the descending aorta upstream of the renal artery. This location can increase blood flow to the kidneys. Alternatively, the device 110 can be disposed within the renal artery. Yet another alternative is to dispose the device 110 downstream of the renal artery immediately prior to the bifurcation of the iliac arteries. In a further example, the device 110 can be disposed in the right ventricle and pump blood through the pulmonary valve.

[0039] FIG. 5 shows a blood assisting device 110 having the same form and function as the device shown in FIG. 4. In other words, FIG. 5 illustrates a blood assisting device 110 that can be disposed in a patient's blood vessel. Additionally, as will be discussed in more detail below, the blood assisting device shown in FIG. 5 may include the power transmission mechanism described and shown in any of FIGS. 1-3.

[0040] Device 110 may include a catheter shaft 115 coupled to the proximal end 129 of housing 120. Housing 120 may be separated by a fluid barrier 135 that is impermeable to fluids including blood into a distal first section 121 and a proximal second section 122. The first section 121 of housing 120 may have at least one side opening 130 that penetrates the wall of housing 120. Fluid barrier 135 extends across the interior of housing 120 and may completely seal off blood leakage to the second section 122 when the first section 121 is filled with blood. Fluid barrier 135 further prevents any fluid within the second section 122 from entering the first section 121 where it may have the potential to enter the bloodstream. Device 110 may further include a first magnet 140 disposed within the first section 121 of housing 120 and coupled to impeller shaft 150 and impeller 160. The first magnet 140 and the impeller 160 may both be coupled to the impeller shaft 150 such that rotation of the first magnet 140 rotates the impeller shaft 150 that rotates the impeller 160. The impeller 160 may be a separate structure from the impeller shaft 150 and may be coupled to the impeller shaft 150. In some examples, the impeller shaft 150 may be disposed within the impeller 160. In other examples, the impeller 160 may be attached to the impeller shaft 150 by adhesion, welding, molding, etc. Alternatively, the impeller 160 and the impeller shaft 150 may be formed as a single monolithic structure. The impeller 160 may be disposed within the first section 121 of housing 120 adjacent to the side opening 130. The distal end 151 of the impeller shaft may be installed in a distal bearing assembly 170 disposed at the distal end 128 of the housing. The distal bearing assembly 170 may be coupled to the housing 120 at separate positions spaced circumferentially around the housing 120 such that the distal end 128 functions as an inlet around the distal bearing assembly 170 and is capable of receiving blood flow into the housing 120. The side opening 130 may function as an outlet through which blood flow can exit the housing. Housing 120 may have a single side opening 130 or multiple side openings 130.When there are multiple side openings 130, they can be circumferentially spaced around a part or the entire circumference of the housing 120. The distal bearing assembly 170 can include a distal bearing 171, a spacer 175, and a bearing housing 180.

[0041] In a second section 122 of the housing 120, the second magnet 142 can be coupled to a drive shaft 190 that can be coupled to a power source 195. The device 110 can be lacking fluid between the second magnet 142 and the drive shaft 190. In the example shown in FIG. 5, the power source 195 can be an electric motor with a power cord 197 that extends proximally outside the body through the catheter shaft 115. Alternatively, the power source can be disposed outside the body, or can be disposed inside the body at a location remote from the device 110. The pivot member 136 can provide an interface between the fluid barrier 135 and the second magnet 142. In addition to preventing fluid from passing between the first section 121 and the second section 122 of the housing 120, the fluid barrier 135 can function as a thrust bearing for the pivot member 136 and the impeller shaft 150 to rotate. In some examples, the fluid barrier 135 can be made of ultra-high molecular weight polyethylene (UHMWPE), polyoxymethylene such as Delrin® acetal homopolymer resin, polyetheretherketone (PEEK), nylon, high density polyethylene (HDPE), or other polymers conventionally used in medical devices, sapphire, ruby, nickel cobalt-based alloys such as MP35N®, cobalt chromium alloys, titanium, titanium alloys, etc. In other examples, the fluid barrier 135 can be filled with fibers or impregnated with oil.

[0042] The first magnet 140 and the second magnet 142 can be of any shape that provides a balanced mass during rotation. In some examples, the first magnet 140 and the second magnet 142 can be cylindrical bipolar magnets, with the N and S poles disposed adjacent to the flat sides facing each other. The N pole of the first magnet 140 can be disposed across the fluid barrier 135 from the S pole of the second magnet 142, or the S pole of the first magnet 140 can be disposed across the fluid barrier 135 from the N pole of the second magnet 142. This orientation of the first and second magnets 140, 142 ensures that the attractive force between the magnets couples the rotational movement of the second magnet 142 to the rotational movement of the first magnet 140. The magnetic force is transmitted through the fluid barrier 135. In use, the power source 195 rotates the drive shaft 190, thereby rotating the second magnet 142, whereby the first magnet 140 rotates at the same speed as the second magnet 142. The rotation of the first magnet 140 rotates the attached impeller shaft 150, which rotates the attached impeller 160. The impeller 160 can be in fluid contact with the blood within the blood vessel, and thus the rotation of the impeller 160 can create suction to draw blood into the distal end 128 of the housing 120 and push the blood out through the side opening 130, thereby increasing the blood flow from the left ventricle to the ascending aorta when the device 110 is disposed as shown in FIG. 4. The fluid barrier 135 prevents leakage of blood into the second section 122 of the housing 120 and thus prevents contact of the blood with the drive shaft 190 and the power source 195.

[0043] In other examples, the first magnet 140 and the second magnet 142 can have three or more poles. Additionally, two or more bipolar or multipolar magnets can be disposed on either side of the fluid barrier 135. Regardless of the number and / or type of magnets used, one or more magnets are configured and arranged such that the rotation of one or more magnets connected to the drive shaft 190 and the power source 195 rotates one or more magnets connected to the impeller 160.

[0044] Figure 6 shows another embodiment of an apparatus 210 for assisting blood flow. The apparatus 210 is similar to that shown in Figure 5, but has a different power source. In the apparatus 110 shown in Figure 5, the power source 195 is shown as an electric motor, whereas in the apparatus 210, the power source is a high - or low - pressure fluid, similar to the exemplary mechanisms shown in Figures 2 and 3. The apparatus 210 shown in Figure 6 may include a catheter shaft 215 coupled to the proximal end 129 of the housing 120. The distal end of the drive shaft 290 may be connected to a second magnet 142, and the proximal end of the drive shaft 290 may be connected to a second impeller 265. The catheter shaft 215 may include an inner lumen 224 and an outer lumen 226. As indicated by arrow 225, a high - or low - pressure fluid, such as saline or other suitable fluid, may be injected through the inner lumen 224 towards the second impeller 265. The high - or low - pressure fluid rotates the second impeller 265, which rotates the drive shaft 290 and the attached second magnet 242. Similar to the apparatus 110, the rotation of the second magnet 142 rotates the first magnet 140, thereby rotating the impeller shaft 150 and the impeller 160. The impeller 160 is in contact with the blood within the blood vessel, and thus the rotation of the impeller 160 assists the blood flow through the blood vessel. After rotating the second impeller 265, as indicated by arrow 222, the high - or low - pressure fluid then returns through the outer lumen 226. The fluid is prevented from entering the blood vessel by the fluid barrier 135. Similarly, the fluid barrier 135 prevents blood from entering the catheter shaft 215 and mixing with the high - or low - pressure fluid. The high - or low - pressure fluid may be provided from a pressurized source outside the body, and the return fluid may be collected and reused outside the body.

[0045] Alternatively, as shown in FIG. 3, the direction of fluid flow can be reversed. High or low pressure fluid can be injected through the outer lumen 226 towards the second impeller 265. The high or low pressure fluid rotates the second impeller 265, which rotates the drive shaft 290 and the attached second magnet 242, which rotates the first magnet 140, thereby rotating the impeller shaft 150 and the impeller 160. After rotating the second impeller 265, the high or low pressure fluid returns through the inner lumen 224.

[0046] FIGS. 7A and 7B show two examples of the housing. A single-piece housing 120 is shown in FIG. 7A. The housing 120 may include a proximal end 129 configured to be coupled to a catheter shaft. In the embodiment shown in FIG. 7A, the proximal end 129 has internal threads. Alternatively, the proximal end 129 can be connected to the catheter shaft by snap fitting, welding, adhesive bonding, etc. The housing 120 may have at least one side opening 130 extending completely through the wall of the housing. If the housing 120 includes a plurality of side openings 130, the plurality of side openings 130 can be spaced around the perimeter of the housing 120 as shown in FIG. 7A. The distal end 128 of the housing 120 may include at least one opening or slot 127 configured to connect to the bearing housing 180 shown in FIGS. 5 and 6.

[0047] A two-piece housing 220 is shown in FIG. 7B. The only difference in the two-piece housing embodiment is the number of parts. The two-piece housing 220 has a proximal portion 223 and a distal portion 221. Similar to the single-piece housing 120, the two-piece housing 220 has a proximally threaded proximal end 229, a plurality of side openings 230, and one or more slots 227 at the distal end 228 of the housing 220.

[0048] FIG. 8 illustrates the distal end region of an exemplary catheter shaft 115 and a second magnet 142, and the structure providing their connection. The catheter shaft 115 may have threads 116 at its distal end for mating with the threaded proximal ends 129, 229 of the housings 120, 220 shown in FIGS. 7A and 7B. Alternatively, the distal end of the catheter shaft 115 may be connected to the proximal end of the housing by a snap fit or a welded joint. The drive shaft 190 may be connected to a power source within the catheter shaft 115 and may have a non-circular shape configured to mate with a non-circular opening 143 passing through the second magnet 142. In some examples, the drive shaft 190 may have at least one flat surface 191 configured to engage with at least one flat surface within the opening 143 passing through the second magnet 142. In the exemplary device shown in FIG. 7, the drive shaft 190 has a cross-sectional arena shape with two opposing flat surfaces 191 that engage with two opposing flat surfaces 144 of the opening 143 passing through the second magnet 142. The engagement between the flat surface 191 of the drive shaft 190 and the flat surface 144 of the opening 143 passing through the second magnet 142 allows for some axial relative movement of the second magnet 142 with respect to the drive shaft 190 while allowing the second magnet 142 to rotate with the drive shaft 190. The allowed axial movement of the second magnet allows the magnetic attraction force to act on the fluid barrier 135 while reducing the axial forces acting on the drive shaft 190 and the power source, and allows the second magnet to be attracted towards the fluid barrier 135. The example shown in FIG. 8 is of a shaft 190 with flat surfaces 191, but the shaft 190 and the opening 143 opening into the second magnet 142 may have any cross-sectional shape that allows for axial movement and rotational coupling between the drive shaft 190 and the second magnet 142. Examples of suitable shapes include "D" shape, arena shape, polygon, star, oval, ellipse, crescent, teardrop, etc.

[0049] As shown in FIG. 9A, the first magnet 140 and the second magnet 142 can have a single-piece structure. Alternatively, as shown in FIGS. 9B and 9C, the first magnet 240 and / or the second magnet 242 can have an insert 245 that defines an opening 243. The insert 245 can be made of a non-magnetic material or a magnetic material. The insert 245 can include a locking mechanism such as a tab 246, as shown in FIGS. 9B and 9C. For any of the first and second magnets 140, 142, 240, 242, the cross-sectional shape of the openings 143, 243 taken perpendicular to the longitudinal axis of the drive shaft can be any non-circular shape that conforms to the cross-sectional shape of the shaft on which the magnet is mounted. The non-circular shape helps to maintain the balance of the shaft when rotating at very high RPMs. In the examples shown in FIGS. 8-10, the cross-sectional shape of the openings 143, 243 is an oval shape with semi-circles at both ends. The oval shape of the openings 143, 243, particularly the opposing flat surfaces 144, 244, mates with an impeller shaft 150 or a drive shaft 190 having flat sides.

[0050] The internal components of the apparatus 110 shown in FIG. 5 are shown in the exploded perspective view of FIG. 10. The pivot member 136 functions as a spacer between the rotating second magnet 142 and the fixed fluid barrier 135, directs the magnetic attraction force of the magnet towards the fluid barrier 135, prevents wear of the second magnet 142, and reduces the axial loads on the drive shaft and the power source. The pivot member 136 may have a proximal protrusion 137 shaped to be received within the opening 143 of the second magnet 142. The shape of the proximal protrusion 137 and the shape of the opening 143 of the second magnet 142 are non-circular to ensure rotation of the proximal protrusion 137 as the second magnet 142 rotates. In some examples, the proximal protrusion 137 may be stadium-shaped and configured to be received within the stadium-shaped opening 143 of the second magnet 142. The fitting of the proximal protrusion 137 within the opening 143 rotates the pivot member 136 together with the second magnet 142. The pivot member 136 may have a distal projection 138 that extends from a bearing surface and is shaped to be received within the proximal recess 133 of the fluid barrier 135. The distal projection 138 and the proximal recess 133 are shaped such that when the distal projection 138 seats in the proximal recess 133, the pivot member 136 rotates relative to the stationary fluid barrier 135. The distal projection 138 and the proximal recess 133 may be conical in shape as shown in FIG. 10. Alternatively, the distal projection 138 and the proximal recess 133 may be spherical. In another example, the pivot member 136 may have a recess in the distal surface shaped to mate with a proximal protrusion on the fluid barrier 135. The pivot member 136 may be made of a material that slides relative to the fluid barrier 135 with minimal friction. For example, the pivot member 136 may be made of materials such as ceramic, zirconia, alumina, cobalt-chromium alloy, titanium alloys such as nitinol, hardened steel, metal coated with diamond-like carbon (DLC) or titanium nitride, ceramic, or polymer. In some examples, a lubricant may be added to the proximal or bearing surface of the pivot member 136.

[0051] The impeller shaft 150 may have a proximal protrusion 152 shaped to fit into the distal recess 131 of the fluid barrier 135. Similar to the distal protrusion 138 and proximal recess 133 of the pivot member, the proximal protrusion 152 and distal recess 131 are shaped such that when the proximal protrusion 152 seats in the distal recess 131, the impeller shaft 150 rotates relative to the stationary fluid barrier 135. The proximal protrusion 152 and distal recess 131 may be conical as shown in FIG. 10, or they may be spherical. The proximal protrusion 152 projects from a disk 153 that extends perpendicular to the longitudinal axis of the impeller shaft 150. Alternatively, the impeller shaft 150 may have a recess formed in the proximal surface of the disk 153 shaped to fit with the distal protrusion of the fluid barrier 135.

[0052] The disk 153 functions as a spacer between the rotating first magnet 140 and the stationary fluid barrier 135, preventing wear of the first magnet 140. The disk 153 positions the first magnet 140 at a desired distance from the second magnet 142. In some examples, this distance is between 0.01 mm and 3.00 mm. Similar to the pivot member 136, the proximal protrusion 152 of the impeller shaft 150 and the disk 153 can be made of a material that slides against the fluid barrier 135 with minimal friction. The impeller shaft 150 can have a proximal region 155 shaped to be received within the opening 143 of the first magnet 140. The proximal region 155 passes through the first magnet 140 and enters the impeller 160. Similar to the drive shaft 190 described above, the proximal region 155 of the impeller shaft 150 can have some non-circular cross-sectional shape that matches the non-circular cross-sectional shape of the opening 143 of the first magnet 140. In the example shown in FIG. 10, the proximal region 155 of the impeller shaft 150 has a cross-sectional arena shape with opposing flat surfaces 158 that mate with the flat surfaces 144 of the opening 143 of the first magnet 140, whereby the first magnet 140 is mechanically fixed to the impeller shaft 150 for torque transmission. The flat surfaces 158 can maintain the balance of the impeller shaft 150 for smooth, vibration-free rotation. By extending the flat surfaces 158 of the impeller shaft 150 into the impeller 160, the impeller 160 is locked to the first magnet 140. The distal region 157 of the impeller shaft 150 can be cylindrical.

[0053] The impeller 160 may have a base 161, a body 162, and at least one blade 163. In the example shown in FIG. 10, the impeller 160 has two opposing blades 163. In other examples, there may be three, four, or more blades. It will be understood that the shape of the blade 163 is exemplary and other shapes of the blade 163 may be provided. The impeller 160 may be disposed within the housing 120 such that the blade 163 is adjacent to the side opening 130. The blade 163 may be shaped such that rotation of the impeller 160 generates suction, draws blood into the housing 120 through the distal end 128 of the housing 120, and pushes the blood out through the side opening 130. Alternatively, the blade 163 may be shaped and configured such that rotation of the impeller 160 draws blood into the housing 120 through the side opening 130 and pushes the blood out through the distal end 128 of the housing. In some examples, the shape of the blade 163 may be opposite to that shown in FIG. 10. The impeller 160 may have a distal opening 168 through which the distal end 151 of the impeller shaft 150 extends. As shown in FIG. 5, the distal end 151 of the impeller shaft 150 may be shaped to mate with a distal bearing assembly 170 fixed to the distal end 128 of the housing 120.

[0054] In the example shown in FIG. 10, the impeller 160 is a separate structure from the impeller shaft 150 and is coupled to the impeller shaft 150. In other examples, the impeller 160 may be fixedly attached to the impeller shaft 150 by adhesion, welding, molding, etc. Alternatively, the impeller 160 and the impeller shaft 150 may be formed as a single monolithic structure. In a further example, the impeller may be formed from blades 163 directly coupled to the impeller shaft 150 by bonding, welding, molding, etc. Alternatively, the blade 163 and the impeller shaft 150 may be formed as a single monolithic structure.

[0055] The distal bearing assembly 170 may include a distal bearing 171, a spacer 175, and a bearing housing 180. The distal end 151 of the impeller shaft 150 may be received in a recess 172 within the distal bearing 171. In the example shown in FIG. 10, the distal end 151 of the impeller shaft 150 and the recess 172 are conical in shape. Alternatively, the distal end 151 of the impeller shaft 150 and the recess 172 may be spherical in shape. The distal bearing 171 may be made of a material that allows the impeller shaft 150 to rotate relative to the distal bearing 171 with minimal friction. The distal bearing 171 may be fixed to a spacer 175 that can slide axially within the bearing housing 180. The bearing housing 180 may be fixed to the housing 120. The bearing housing 180 may have at least one fin 182 that extends radially outward and is configured to mate with a slot 127 in the housing 120 shown in FIG. 7A. The distal bearing assembly 170 positions the impeller shaft 150 at the center of the housing 120 with the longitudinal axis of the impeller shaft 150 aligned with the longitudinal axis of the housing 120. The distal bearing assembly 170 may allow limited axial movement of the impeller shaft 150 within the housing 120.

[0056] FIG. 11 shows the assembled apparatus of FIG. 10. As shown in FIG. 11, the fins 182 of the bearing housing 180 are configured such that when the fins 182 are attached to the slot 127 of the housing 120, blood can flow into the distal end 128 of the housing 120 from between the fins 182. The blood flow is indicated by arrow 184. The blood flows into the space 183 between adjacent fins 182 and through the interior of the housing 120. The rotating impeller blade 163 discharges blood from the side opening 130, as indicated by arrow 185.

[0057] FIG. 12 is a proximal end view of an exemplary impeller shaft 150 showing the structure of disk 153. Disk 153 may have two opposing inclined grooves or lobes 154, 156, which create outward turbulence and remove any blood that would otherwise tend to accumulate between first magnet 140 and fluid barrier 135.

[0058] Details of the internal structure of impeller 160 are shown in FIG. 13. Impeller 160 may have a central channel 169 that extends along the longitudinal axis of impeller 160. A first region 164 of channel 169 may extend through base 161, and a second region 167 of channel 169 may extend through body 162. First region 164 may be shaped to receive the proximal region 155 of impeller shaft 150. In the example shown in FIG. 13, first region 164 is in the shape of an arena with opposing flat sides 166 that engage the flat surface 158 of impeller shaft 150. Second region 167 may be rounded to fit the rounded distal region 157 of impeller shaft 150. Central channel 169 terminates at distal opening 168.

[0059] FIG. 14 shows an alternative distal bearing assembly 270 disposed within the distal end of the housing 120. The distal bearing assembly 270 may include a distal bearing 271, a spacer 275, and a bearing housing 280. The distal end 151 of the impeller shaft 150 may be received within a recess 272 within the distal bearing 271. In the example shown in FIG. 14, the distal end 151 of the impeller shaft 150 and the recess 272 are conical in shape, and the recess 272 is considerably larger than the distal end 151 of the impeller shaft 150. Alternatively, the distal end 151 of the impeller shaft 150 and the recess 272 may be spherical in shape. The distal bearing 271 may be made of a material that allows the impeller shaft 150 to rotate relative to the distal bearing 271 with minimal friction. The distal bearing 271 may be embedded within the spacer 275. The spacer 275 may slide axially within the bearing housing 280. The spacer 275 may have a proximal ridge 276. A spring member 278 may be circumferentially disposed around the outer surface of the spacer 275 between the proximal ridge 276 and the bearing housing 280. The spring member 278 provides a light but constant pressure on the impeller shaft 150, maintaining the impeller shaft 150 centered within the housing 120 and allowing the impeller shaft 150 to rotate smoothly. In some examples, the spring member 278 may be metallic. In other examples, the spring member 278 may be made of an elastic material. The bearing housing 280 may be fixed to the housing 120. The bearing housing 280 may have at least one fin 282 configured to mate with a slot 127 of the housing 120.

[0060] The materials that can be used for the various components of the devices 110, 210 for assisting blood flow (and / or other systems or components disclosed herein) and the various elements thereof disclosed herein may include those commonly associated with medical devices. For simplicity, in the following description, reference is made to the devices 110, 210 (and the variations, systems, or components disclosed herein). However, this is not intended to limit the devices and methods described herein, as the description may be applicable to other elements, members, components, or devices disclosed herein.

[0061] In some embodiments, the devices 110, 210 (and variations, systems, or components thereof disclosed herein) can be made of metal, metal alloy, ceramic, zirconia, polymer (some examples of which are disclosed below), metal-polymer composites, combinations thereof, etc., or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 444V, 444L, 314LV stainless steel; mild steel; nickel-titanium alloys such as linear elastic nitinol and / or superelastic nitinol; cobalt-chromium alloys, titanium and its alloys, alumina, diamond-like carbon coating (DLC) or metal coated with titanium nitride coating, other nickel alloys such as nickel-chromium-molybdenum alloy (e.g., UNS:N06625 such as INCONEL® 625, UNS:N06022 such as HASTELLOY® C-22®, HASTELLOY® C276®, other HASTELLOY® alloys such as UNS:N10276), nickel-copper alloys (e.g., UNS:N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloy (e.g., UNS:R44035 such as MP35-N®), nickel-molybdenum alloy (e.g., UNS:N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS:R44003 such as ELGILOY®, PHYNOX®); platinum-reinforced stainless steel; titanium; platinum; palladium; gold; combinations thereof; others; or other suitable materials are included.

[0062] As mentioned herein, the family of commercially available nickel-titanium or nitinol alloys includes a category designated as "linearly elastic" or "non-superelastic", which may be chemically similar to conventional shape memory and superelastic types, but may exhibit usefully distinct mechanical properties. Linearly elastic and / or non-superelastic nitinol can be distinguished from superelastic nitinol in that the linearly elastic and / or non-superelastic nitinol does not exhibit a substantial "superelastic plateau" or "flag region" seen in superelastic nitinol in its stress / strain curve. Instead, in linearly elastic and / or non-superelastic nitinol, as the recoverable strain increases, the stress increases in a nearly linear, i.e., somewhat linear, but not necessarily linear relationship all the way until plastic deformation begins, or at least in a more linear relationship than the superelastic plateau and / or flag region seen in superelastic nitinol. Thus, for the purposes of the present invention, linearly elastic and / or non-superelastic nitinol may also be referred to as "substantially" linearly elastic and / or non-superelastic nitinol.

[0063] In some cases, linearly elastic and / or non-superelastic nitinol can also be distinguished from superelastic nitinol in that the linearly elastic and / or non-superelastic nitinol can accept up to about 2%-5% strain while generally maintaining elasticity (e.g., before plastic deformation begins), while superelastic nitinol can accept up to about 8% strain before plastic deformation. Both of these materials can be distinguished from other linearly elastic materials, such as stainless steel, which can only accept up to about 0.2% - 0.44% strain before plastic deformation (and are also distinguishable based on their composition).

[0064] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy is an alloy that does not exhibit a martensite / austenite phase change detectable by differential scanning calorimetry (DSC) and dynamic mechanical thermal analysis (DMTA), which are analyses over a wide temperature range. For example, in some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy may not have a martensite / austenite phase change detectable by DSC and DMTA analyses in the range of about -60 degrees Celsius (°C) to about 120 °C. Thus, the mechanical bending properties of such materials can generally be inert to temperature effects over this very wide temperature range. In some embodiments, the mechanical bending properties of the linear elastic and / or non-superelastic nickel-titanium alloy at ambient temperature or room temperature are generally the same as the mechanical properties at body temperature, for example, in that they do not exhibit a superelastic plateau and / or flag region. For example, over a wide temperature range, the linear elastic and / or non-superelastic nickel-titanium alloy maintains its linear elastic and / or non-superelastic properties and / or characteristics.

[0065] In some embodiments, the linear elastic and / or non-superelastic nickel-titanium alloy can range from about 50 to about 60 weight percent nickel, with the balance being generally titanium. In some embodiments, the composition ranges from about 54 to about 57 weight percent nickel. An example of a suitable nickel-titanium alloy is the FHP-NT alloy commercially available from Furukawa Techno-Materials Co., Ltd. in Kanagawa Prefecture, Japan. Other suitable materials can include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, superelastic alloys, such as superelastic nitinol, can be used to achieve the desired properties.

[0066] In at least some embodiments, some or all of the devices 110, 210 (and variations, systems or components thereof disclosed herein) may also be doped, manufactured, or otherwise include a radiopaque material. A radiopaque material is a material that can generate a relatively bright image on a fluoroscopic screen, i.e., is understood to be another imaging technique during a medical procedure. This relatively bright image helps the user to determine the location of the devices 110, 210 (and variations, systems or components thereof disclosed herein). Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials filled with radiopaque fillers, etc. Additionally, other radiopaque marker bands and / or coils can also be incorporated into the design of the devices 110, 210 (and variations, systems or components thereof disclosed herein) to achieve the same result.

[0067] In some embodiments, the apparatus 110, 210 (and variations, systems or components thereof disclosed herein) and / or a part thereof can be made of or include a polymer or other suitable material. Some examples of suitable polymers include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, e.g., DELRIN® available from DuPont), polyether block ester, polyurethane (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether-ester (e.g., ARNITEL® available from DSM Engineering Plastics), ether or ester-based copolymers (e.g., butylene / poly(alkylene ether) phthalate and / or other polyester elastomers such as HYTREL® available from DuPont), polyamide (e.g., DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamide, block polyamide / ether, polyether block amide (PEBA, e.g., available under the trade name PEBAX®), ethylene vinyl acetate copolymer (EVA), silicone, polyethylene (PE), Marlex high density polyethylene, Marlex low density polyethylene, linear low density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyether ether ketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (e.g., GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC),Poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomer, polyurethane silicone copolymer (e.g., ElastEon® of Aortech Biomaterials or ChronoSil® of AdvanSource Biomaterials), biocompatible polymer, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites thereof, etc. are included. In some embodiments, the sheath may be blended with a liquid crystal polymer (LCP). For example, the mixture can include up to about 6 percent LCP.,

[0068] In some embodiments, the devices 110, 210 (and variations, systems, or components thereof disclosed herein) may contain a suitable therapeutic agent and / or may be treated with a suitable therapeutic agent. Some examples of suitable therapeutic agents include antithrombotic agents (such as heparin, heparin derivatives, urokinase, and PPack (dextrorphan proline arginine chloromethyl ketone)); antiproliferative agents (such as enoxaparin, angiopeptin, monoclonal antibodies capable of inhibiting smooth muscle cell proliferation, hirudin, acetylsalicylic acid, etc.); anti-inflammatory agents (such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, mesalamine, etc.); antitumor / antiproliferative / antimitotic agents (such as paclitaxel, 5-fluorouracil, cisplatin, vincristine, vinblastine, epothilone, endostatin, angiostatin, and thymidine kinase inhibitors, etc.); anesthetics (such as lidocaine, bupivacaine, ropivacaine, etc.); anticoagulants (such as D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, heparin, antithrombin compounds, platelet receptor antagonists, antithrombin antibodies, antiplatelet receptor antibodies, aspirin, prostaglandin inhibitors, platelet inhibitors, and tick antiplatelet peptides); vascular cell growth promoters (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional activators, translational promoters, etc.); vascular cell growth inhibitors (such as growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies against growth factors, bifunctional molecules consisting of growth factors and cytotoxins, bifunctional molecules consisting of antibodies and cytotoxins); cholesterol-lowering drugs; vasodilators; agents that interfere with endogenous vasoactive mechanisms.

[0069] (Appendix) As a preferred embodiment, the technical idea that can be grasped from the above embodiments will be described below. [Item 1] A medical device comprising: a housing having a longitudinal axis and including at least one inlet for receiving blood flow and at least one outlet for delivering blood flow; A fluid-impermeable fluid barrier that separates the housing into a first section disposed within the housing and including at least one inlet and at least one outlet, and a second section. An impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outward from the body. At least one first magnet coupled to an impeller shaft coupled to the impeller, the first magnet being disposed within the first section of the housing and coupled to the impeller shaft such that rotation of the first magnet rotates the impeller. A drive shaft disposed within the second section of the housing. At least one second magnet disposed on the drive shaft within the second section of the housing, the second magnet being configured and arranged with the first magnet such that rotation of the second magnet rotates the first magnet and allows axial movement of the second magnet along the drive shaft to allow the second magnet to be attracted toward the fluid barrier while being rotatably coupled to the drive shaft, whereby a pulling magnetic force acts on the fluid barrier and allows reduction of an axial load applied to the drive shaft. A pivot member disposed longitudinally between the second magnet and the fluid barrier, the pivot member having a non-circular proximal protrusion configured to engage a non-circular opening of the second magnet for rotation of the pivot member by rotation of the second magnet, and further having a circular distal protrusion configured to engage a circular opening of the fluid barrier such that the pivot member is rotatable against the fluid barrier. A medical device comprising. [Item 2] The medical device according to item 1, further comprising a power source coupled to the drive shaft, and reducing the load acting on the power source by allowing axial movement of the second magnet. [Item 3] The medical device according to item 2, wherein the power source is disposed within a catheter shaft attached to the second section of the housing. [Item 4] The medical device according to item 3, wherein the power source is a motor. [Item 5] The power source is a second impeller connected to the drive shaft, the catheter shaft defines a fluid flow path, fluid impinging on the second impeller drives the second impeller, the second impeller rotates the second magnet, rotation of the second magnet rotates the first magnet, thereby rotating the impeller shaft and the impeller, and the drive shaft and the second impeller are disposed within the fluid flow path, according to item 3 of the medical device. [Item 6] The at least one outlet includes a plurality of side openings spaced around the housing, and the impeller is disposed within the housing such that at least one blade is disposed adjacent to the plurality of side openings, according to item 1 of the medical device. [Item 7] The proximal end of the impeller shaft extends proximally of the first magnet, and the proximal end has a first protrusion configured to be received by a first recess of the fluid barrier, according to item 1 of the medical device. [Item 8] The impeller shaft includes a disk adjacent to the first protrusion, and the disk extends perpendicular to the longitudinal axis of the impeller shaft, according to item 7 of the medical device. [Item 9] The medical device according to item 8, wherein the disk has two opposing lobes. [Item 10] The medical device according to item 1, further comprising a bearing assembly configured to support and center the distal end of the impeller shaft, the bearing assembly including a bearing housing fixed to the housing, a spacer slidably disposed within the bearing housing, and a distal bearing fixed within the spacer. [Item 11] The medical device according to item 10, wherein the bearing assembly further includes a spring member disposed around the spacer. [Item 12] A medical device for implantation within a patient's body, comprising an inlet for receiving blood flow and a plurality of side openings for delivering blood flow, having a longitudinal axis and being sized to be disposed within the heart, and a housing, a fluid-impermeable fluid barrier disposed within the housing and separating the housing into a first section and a second section, the first section including the inlet and the plurality of side openings, an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outward from the body, at least one first magnet disposed within the first section of the housing, the first magnet being coupled to the impeller such that rotation of the first magnet rotates the impeller, a drive shaft disposed within the second section of the housing, the drive shaft having a stop surface and at least one flat surface extending from the stop surface, At least one second magnet coupled to the drive shaft and disposed within the second section of the housing, such that rotation of the second magnet rotates the first magnet and allows the second magnet to be attracted toward the fluid barrier, while allowing axial movement of the second magnet along the drive shaft between a stop surface of the drive shaft and a spacer disposed between the second magnet and the fluid barrier, and thereby coupling the second magnet to the drive shaft, so that the attracting magnetic force between the magnets acts on the fluid barrier and allows reduction of an axial load applied to the drive shaft and the drive source, the second magnet being configured and disposed together with the first magnet, comprising The first magnet has a first opening configured to receive and couple an impeller shaft through the first magnet, and the second magnet has a second opening configured to receive and couple the drive shaft through the second magnet, and the first opening and the second opening each have a first cross-sectional shape that is perpendicular to the longitudinal axis of the drive shaft, The drive shaft has a second cross-sectional shape that intersects the at least one flat surface and is perpendicular to the longitudinal axis of the drive shaft, and at least a portion of the impeller shaft has a second cross-sectional shape that is perpendicular to the longitudinal axis of the impeller shaft, and the first cross-sectional shape and the second cross-sectional shape are formed non-circularly such that rotation of the impeller shaft and the drive shaft rotates the first magnet and the second magnet, respectively, A medical device. [Item 13] The medical device further comprises a catheter shaft, the drive source is a second impeller connected to the drive shaft, the catheter shaft defines a fluid flow path, and the fluid impinging on the second impeller drives the second impeller, the second impeller rotates the second magnet, and the second magnet rotates the first magnet, thereby rotating the impeller, wherein the drive shaft and the second impeller are disposed within the fluid flow path, the medical device according to item 12. [Item 14] The medical device according to item 12 further comprises an impeller shaft disposed and coupled to the impeller and the first magnet, and a bearing assembly configured to support and center the distal end of the impeller shaft, the bearing assembly including a bearing housing fixed to the housing, a spacer slidably disposed within the bearing housing, and a distal bearing fixed within the spacer. [Item 15] The drive shaft rotates within the second section of the housing, thereby rotating the second magnet, and the second magnet is configured to rotate the first magnet, such that when the medical device is disposed within the ascending aorta, the medical device is configured to draw blood into the housing through at least one inlet of the housing from the left ventricle and send the blood into the ascending aorta through at least one outlet, generating suction to enable this, the medical device according to item 1, wherein the impeller shaft and the impeller are configured to rotate. [Item 16] A medical device for implantation within a patient's heart, comprising at least one inlet for receiving blood flow and at least one outlet for delivering blood flow, having a longitudinal axis, and a housing sized to be suitable for placement within the heart, A fluid barrier disposed within the housing, the fluid barrier separating the housing into a first section including at least one inlet and at least one outlet, and a second section, being impermeable to fluid, and having a first side and a second side opposite the first side, the fluid barrier; An impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller; A drive shaft disposed within the second section of the housing; A first magnet coupled to an impeller shaft coupled to the impeller, the first magnet being disposed within the first section of the housing and coupled to the impeller shaft such that rotation of the first magnet rotates the impeller; A second magnet disposed on the drive shaft within the second section of the housing, the second magnet being configured and arranged with the first magnet such that rotation of the second magnet rotates the first magnet; A disk coupled to the impeller shaft, the disk having a protrusion extending therefrom, the disk; A pivot member disposed between the fluid barrier and the second magnet, the pivot member having at least one protrusion extending therefrom, the pivot member; Comprising; The at least one protrusion of the pivot member is configured to engage the second side of the fluid barrier and the at least one protrusion of the disk is configured to engage the first side of the fluid barrier such that the fluid barrier functions as a thrust bearing for rotation of the pivot member and thus the impeller shaft; A medical device. [Item 17] The medical device according to item 16, further comprising a distal bearing assembly disposed at a distal end of the housing, the distal bearing assembly including a distal bearing configured to receive a portion of the impeller shaft, a spacer fixed to the distal bearing, and a bearing housing fixed to the housing of the medical device, wherein the spacer is configured to be axially slidable within the bearing housing. [Item 18] The medical device according to item 17, wherein the distal bearing assembly has a recess for receiving a distal end of the impeller shaft, and the distal end of the impeller shaft and the recess of the distal bearing are conical in shape. [Item 19] The medical device according to item 18, wherein the bearing housing has at least one fin extending radially outward, the housing has at least one slot, and the at least one fin of the bearing housing is received within the at least one slot of the housing. [Item 20] The medical device according to item 18, wherein the distal bearing assembly further includes a spring member, the spring member is circumferentially disposed around an outer surface of the spacer, and is configured to maintain the impeller shaft at a center within the housing. [Item 21] The medical device according to item 1, wherein the fluid barrier functions as a thrust bearing that allows the pivot member to rotate. It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made without departing from the scope of the invention, particularly with regard to details, especially the shape, size, and arrangement of steps. This may include the use of any of the features of one exemplary embodiment in other embodiments, within the appropriate scope. Of course, the scope of the invention is defined by the language of the appended claims.

Claims

**Claim 1** A medical device, the medical device comprising a housing, the housing including at least one inlet for receiving blood flow and at least one outlet for supplying blood flow, the housing having a longitudinal axis, the medical device comprising a fluid barrier disposed within the housing and separating the housing into a first section including at least one inlet and at least one outlet and a second section, the fluid barrier being impermeable to fluid, the medical device comprising an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outwardly from the body, the medical device comprising at least one first magnet coupled to an impeller shaft, the first magnet being disposed within the first section of the housing and rotatably coupled to the impeller shaft, the medical device comprising a drive shaft disposed within the second section of the housing, the medical device comprising at least one second magnet disposed on the drive shaft within the second section of the housing, the first magnet and the second magnet being configured and arranged such that rotation of the second magnet rotates the first magnet, a proximal end of the impeller shaft extending proximal to the first magnet, A medical device. **Claim 2** The medical device according to claim 1, wherein the proximal end has a first protrusion configured to be received by a first recess formed in the fluid barrier. **Claim 3** The medical device according to claim 2, wherein the impeller shaft includes a disk adjacent to the first protrusion, the disk extending perpendicular to the longitudinal axis of the impeller shaft. **Claim 4** The medical device according to claim 3, wherein the disk has two opposing lobes. **Claim 5** The medical device according to any one of claims 1 to 4, further comprising a pivot member disposed between the second magnet and the fluid barrier. **Claim 6** The medical device according to claim 5, wherein the pivot member has a protrusion extending distally from the pivot member, the protrusion being configured to be received by a second recess formed in the fluid barrier.

7. The impeller shaft has a proximal region configured to be received by an opening in the first magnet, and the proximal region penetrates the first magnet and enters the impeller. The medical device according to any one of claims 1 to 4.

8. The proximal region has a non-circular cross-sectional shape that matches the non-circular cross-sectional shape of the opening of the first magnet. The non-circular cross-sectional shape of the proximal region extends at least partially into the impeller so that the impeller is fixed to the first magnet. The medical device according to claim 7.

9. The impeller includes a central channel extending along the axis of the impeller. A first region of the central channel extends through the base of the impeller and is configured to receive the proximal region. A second region of the central channel extends through the body and is configured to receive a cylindrical distal region of the impeller shaft. The medical device according to claim 8.

10. The impeller includes a central channel extending along the axis of the impeller. A first region of the central channel extends through the base of the impeller and is configured to receive the proximal region. A second region of the central channel extends through the body and is configured to receive a cylindrical distal region of the impeller shaft. The medical device according to claim 7.

11. The medical device includes a distal bearing assembly configured to support the distal end of the impeller shaft. The medical device according to any one of claims 1 to 4.

12. The distal bearing assembly includes a bearing housing fixed to the housing, a spacer disposed within the bearing housing, and a distal bearing coupled to the distal end of the impeller shaft and the spacer. The medical device according to claim 11.

13. The distal end of the housing has at least one opening or slot configured to be connected to the bearing housing. The medical device according to claim 12.

14. The distal bearing assembly is configured to allow limited axial movement of the impeller shaft within the housing. The medical device according to claim 11.

15. The medical device according to claim 11, wherein the distal bearing assembly comprises a spring member configured to apply pressure to the impeller shaft so that the impeller shaft is centered within the housing.

16. The medical device according to any one of claims 1 to 4, further comprising a power source coupled to the drive shaft, the power source being an electric motor comprising a power cord extending proximally through a catheter shaft coupled to the proximal end of the housing.

17. The medical device according to any one of claims 1 to 4, wherein the at least one outlet includes a plurality of side openings spaced around the housing, and the impeller is disposed within the housing such that at least one blade is disposed adjacent to the plurality of side openings.

18. A medical device, comprising a housing having a longitudinal axis and including at least one inlet for receiving blood flow and at least one outlet for supplying blood flow. The medical device includes a fluid barrier disposed within the housing and separating the housing into a first section including at least one inlet and at least one outlet and a second section, the fluid barrier being fluid-impermeable. The medical device includes an impeller disposed within the first section of the housing, the longitudinal axis of the impeller being the same as the longitudinal axis of the housing, the impeller having a body and at least one blade extending radially outwardly from the body. The medical device includes a first magnet disposed in the first section of the housing proximal to the impeller. The medical device includes an impeller shaft extending through the first magnet and entering the impeller, the impeller shaft being rotatably coupled to the first magnet and the impeller. The medical device includes a drive shaft disposed within the second section of the housing. The medical device comprises at least one second magnet disposed on the drive shaft within the second section of the housing, and the first magnet and the second magnet are configured and arranged such that rotation of the second magnet causes rotation of the first magnet. The proximal end of the impeller shaft extends proximally of the first magnet. Medical device. **Claim 19** The medical device according to claim 18, comprising a bearing assembly configured to support the distal end of the impeller shaft. **Claim 20** The medical device according to claim 19, wherein the bearing assembly comprises a bearing housing fixed to the housing, a spacer disposed within the bearing housing, and a distal bearing coupled to the distal end of the impeller shaft and the spacer.

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