INTRAVASCULAR BLOOD PUMP ROTOR
20220323742 · 2022-10-13
Assignee
Inventors
Cpc classification
F04D13/027
MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
A61M60/237
HUMAN NECESSITIES
A61M60/422
HUMAN NECESSITIES
A61M60/13
HUMAN NECESSITIES
A61M60/221
HUMAN NECESSITIES
International classification
A61M60/221
HUMAN NECESSITIES
A61M60/148
HUMAN NECESSITIES
A61M60/422
HUMAN NECESSITIES
Abstract
Disclosed is a blood pump rotor, and an intravascular blood pump that utilizes the rotor. The blood pump rotor is configured to rotate around an axis of rotation, and comprises a distal portion and a proximal portion. The distal portion includes a rotor hub, which tapers in a distal direction. The rotor hub has at least one blade extending outward from the rotor hub. Further, a distal end of said rotor hub extends distally beyond a most distal portion of the at least one blade. The proximal portion, which is connected to the distal portion, has permanent magnets arranged so as to form a modified Halbach array generating a magnetic field having a magnetic flux in a proximal direction that is greater than a magnetic flux in a distal direction, said first magnetic flux being greater than said second magnetic flux. The Halbach array is modified such that either (a) at least one axial magnetized magnet has a most proximal point or portion of a surface that is a different distance from said distal end as compared to a most proximal point or portion of a surface of at least one circumferential magnetized magnet, (b) at least one axial magnetized magnet has a physical dimension that is different from a corresponding physical dimension of at least one circumferential magnetized magnet, or (c) a combination thereof.
Claims
1. An intravascular blood pump rotor, comprising: a distal portion having a rotor hub tapering in a distal direction and configured to rotate around an axis of rotation, at least one blade extending outward from said rotor hub, and a distal end of said rotor hub extending distally beyond a most distal portion of said at least one blade; and a proximal portion connected to the distal portion having permanent magnets arranged so as to form a modified Halbach array generating a magnetic field having a first magnetic flux in a proximal direction and a second magnetic flux in a distal direction, said first magnetic flux being greater than said second magnetic flux, said modified Halbach array comprising an alternating arrangement of axial magnetized magnets and circumferential magnetized magnets, wherein at least one of said axial magnetized magnets has a most proximal point or portion of a surface that is a different distance from said distal end as compared to a most proximal point or portion of a surface of at least one of said circumferential magnetized magnets.
2. The intravascular blood pump rotor according to claim 1, wherein a proximal surface of each circumferential magnetized magnet is a first distance axially from said distal end, and a proximal surface of each axial magnetized magnet is a second distance axially from said distal end, said second distance being greater than said first distance.
3. The intravascular blood pump rotor according to claim 1, wherein a difference between said first distance and said second distance is between 1 and 7 mm.
4. The intravascular blood pump rotor according to claim 1, wherein at least two of said proximal surfaces of said circumferential magnetized magnets are not coplanar.
5. An intravascular blood pump, comprising a pump casing having a blood flow inlet and a blood flow outlet; an intravascular blood pump rotor according to claim 1; and an electric drive unit capable of magnetically interacting with said intravascular blood pump rotor.
6. The intravascular blood pump according to claim 5, wherein said electric drive unit comprises a 2-, 4-, or 6-pole stator.
7. The intravascular blood pump according to claim 5, wherein each circumferential magnetized magnet is further from a distal end of said electric drive unit than each axial magnetized magnet.
8. The intravascular blood pump according to claim 5, wherein said intravascular blood pump is an axial-type blood pump.
9. An intravascular blood pump rotor, comprising: a distal portion having a rotor hub tapering in a distal direction and configured to rotate around an axis of rotation, at least one blade extending outward from said rotor hub, and a distal end of said rotor hub extending distally beyond a most distal portion of said at least one blade; and a proximal portion connected to the distal portion having permanent magnets arranged so as to form a modified Halbach array generating a magnetic field having a first magnetic flux in a proximal direction and a second magnetic flux in a distal direction, said first magnetic flux being greater than said second magnetic flux, said modified Halbach array comprising an alternating arrangement of axial magnetized magnets and circumferential magnetized magnets, wherein at least one of said axial magnetized magnets has a physical dimension that is different from a corresponding physical dimension of at least one of said circumferential magnetized magnets.
10. The intravascular blood pump rotor according to claim 9, wherein each of said permanent magnets comprises two side surfaces extending radially away from said axis of rotation, said two side surfaces for each of said plurality of permanent magnets forming either two parallel flat surfaces, two non-parallel flat surfaces, or a concave curved surface and a convex curved surface.
11. The intravascular blood pump rotor according to claim 9, wherein said permanent magnets each have an outer surface with a cross-sectional shape forming an arc of a circle about said axis of rotation, an angle subtended by each arc from said axis of rotation being between 1° and 89°.
12. The intravascular blood pump rotor according to claim 11, wherein said permanent magnets comprise a first magnet and a second magnet, and an angle subtended by an arc from said first magnet is different from an angle subtended by an arc from said second magnet.
13. The intravascular blood pump rotor according to claim 12, wherein at least one of said angles is greater than 45°.
14. The intravascular blood pump rotor according to claim 13, wherein at least one of said angles is less than 45°.
15. The intravascular blood pump rotor according to claim 9, wherein said physical dimension comprises a length of an arc formed by a cross-section of an outer surface of each magnet.
16. The intravascular blood pump rotor according to claim 9, wherein said physical dimension comprises a length of each magnet in an axial direction.
17. The intravascular blood pump rotor according to claim 9, wherein said physical dimension comprises a length of an arc formed by a cross-section of an outer surface of each magnet, and a length of each magnet in an axial direction.
18. The intravascular blood pump rotor according to claim 9, further comprising a blade on a proximal surface of at least one circumferential magnetized magnet, extending axially in a proximal direction.
19. An intravascular blood pump, comprising a pump casing having a blood flow inlet and a blood flow outlet; an intravascular blood pump rotor according to claim 9; and an electric drive unit capable of magnetically interacting with said intravascular blood pump rotor.
Description
BRIEF DESCRIPTION OF DRAWINGS
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DETAILED DESCRIPTION
[0037] Referring to
[0038] The rotor 1 (which may sometimes be referred to as an impeller) is configured to rotate about the axis of rotation 5 by means of a first bearing 31 and a second bearing 32. Both bearings 31, 32 are contact-type bearings in this embodiment. At least one of the bearings 31, 32 could be a non-contact-type bearing, however, such as a magnetic or hydrodynamic bearing. The first bearing 31 is a pivot bearing having spherical bearing surfaces that allow for rotational movement as well as pivoting movement to some degree.
[0039] The distal portion 10 includes a rotor hub 11 tapering in a distal direction towards the most distal end 12 of the rotor hub 11. The second bearing 32 is typically connected to rotor 1 at the most distal end 12 of rotor hub 11. At least one blade 15 is provided on the rotor 1 for conveying blood once the rotor 1 rotates. Any blade 15 is generally connected to rotor hub 11. Distal end 12 of the rotor hub 11 extends distally beyond a most distal portion of blade 15. and
[0040] The proximal portion 20 contains permanent magnets 21 arranged so as to form a modified Halbach array.
[0041] Referring briefly to
[0042] Referring to
[0043] Rather than having the strong/weak magnetic fluxes be generated in a radial direction as is typically done, the modified Halbach arrays of the present disclosure generate these strong/weak magnetic fluxes in an axial direction. That is, the modified Halbach array in the presently disclosed rotor generates a magnetic field having a first magnetic flux 120 in a proximal direction and a second magnetic flux 110 in a distal direction. The first magnetic flux 120 is greater than the second magnetic flux 110.
[0044] Additionally, the traditional cylindrical Halbach arrays shown in
[0045] First Modification Approach
[0046] The first modification approach is to modify the arrangement of magnets in an axial direction. This technique involves creating differences in positioning and/or orientation of proximal surfaces of axial and circumferential magnetized magnets in the Halbach array.
[0047] In particular, as shown in
[0048] Various embodiments of this can be illustrated with reference to
[0049] In particular,
[0050] As the most proximal surfaces 302, 304, 305 in the illustration are flat, any point can be considered the most proximal portion, and thus, the difference 309 in axial locations of the most proximal portions of an axial magnetized magnet 301 and a circumferential magnetized magnet 303 can be readily determined.
[0051] If the physical dimensions of the magnets are identical, this difference in axial positioning can be created by simply offsetting the axial positioning of the axial magnetized magnets as compared to the circumferential magnetized magnets. This is illustrated in
[0052]
[0053] As seen in
[0054] In preferred embodiments, the difference in axial position is between 1 mm and 7 mm. Said differently, the most proximal portion of the circumferential magnetized magnet is preferably between 1 mm and 7 mm closer to the distal end of the rotor than the most proximal portion of the axial magnetized magnet. In some embodiments, this difference is at least 0.5 mm, 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm, and no more than 10 mm, 8 mm, 7 mm, 6 mm, 5 mm, 4 mm, 3 mm, or 2 mm, including all possible combinations and subranges thereof.
[0055] In preferred embodiments, the most proximal portion of each circumferential magnetized magnet is an identical distance from the distal end of the rotor, and the most proximal portion of each axial magnetized magnet is an identical distance from the distal end of the rotor. In some embodiments, however, that may not be desirable, and thus other combinations are envisioned.
[0056] For example, in some embodiments, the most proximal surfaces of the circumferential magnetized magnets are not all equally distant from the distal end of the rotor, while the most proximal surfaces of all axial magnetized magnets are. In other embodiments, the reverse is true, the most proximal surfaces of all circumferential magnetized magnets are at equal distances from the distal end of the rotor, while at least some of the most proximal surfaces of the axial magnetized magnets are not And in still other embodiments, the most proximal surfaces of the circumferential magnetized magnets are not all equally distant from the distal end of the rotor, and the most proximal surfaces of all axial magnetized magnets are also not equally distant from the distal end of the rotor.
[0057] Additionally, in some embodiments, at least two of the most proximal surfaces of the circumferential magnetized magnets are not coplanar. This may result from, for example, magnets having proximal surfaces that are angled or curved in a circumferential direction and/or a radial direction. For instance, as seen in
[0058] In
[0059] A first subportion 343 of the most proximal surface of each second portion 340 may be parallel to the first portion. That is, in some embodiments, there may be a flat runout zone where the pressure can be distributed over the surface and the fluid can flow off the second portion 340.
[0060] A second subportion 342 of the most proximal surface of each section portion 340 may be contoured in some embodiments, the contour is a rising contour in the counterclockwise direction (opposite the direction of rotation). The contour may taper a distance 348 from a most distal point 349 (such as a point near the leading surface 344) to a most proximal point 350 (such as a point at or near the trailing surface 345 or the first subportion 343) That is, one part (e.g., ref. 349) of the most proximal surface of the second portion 340 may be closer to the first portion 335 in an axial direction than a second part (e.g., ref. 350) of the most proximal surface of the second portion by a distance 348.
[0061] In some embodiments, no portion of the second subportion 342 is coplanar with the first subportion 343. In some embodiments, the second subportion 342 comprises a curved surface (e.g., a concave or convex surface). In some embodiments, the second subportion 342 comprises a substantially flat surface at a fixed angle relative to the first portion 340.
[0062] In some embodiments, the second subportion 340 may include sidewalls, such as a trailing sidewall 346 at the trailing surface 345, or an outer sidewall 347 at the outer surface 334 of the array. These sidewalls may be used to control the flow of blood, reducing flow in a radial direction, etc.
[0063] Further, a skilled artisan will recognize that although the magnets illustrated in the figures are shown as having sharp corners, the edges may be fully or partially beveled, chamfered, rounded, etc.
[0064] Second Modification Approach
[0065] The second modification approach is to configure a physical dimension of at least one axial magnetized magnet to be different from the corresponding physical dimension of at least one circumferential magnetized magnet. That is, rather than all magnets being generally identical except for magnetization direction, the physical dimensions are tweaked such that the axial magnetized magnets are physically different form the circumferential magnetized magnets.
[0066] Referring to
[0067] In preferred embodiments, each permanent magnet has an outer surface 402 with a cross-sectional shape forming an arc of a circle about said axis of rotation 499. The physical dimensions of the arcs are such that the angle 405 subtended by each arc from the axis of rotation 499 is most preferably between 1° and 89°. In some embodiments, the angle is at least 1°, 5°, 10°, 15° or 20°, and no more than 89°, 80°, 70°, 60°, 50°, or 40° including all possible combinations and subranges thereof. For example, in some embodiments, the angle is between 5° and 70°, between 10° and 80°, or between 20° and 70°.
[0068] In some embodiments, when the magnets are arranged in a modified Halbach array, the angle subtended by the arc of the outer surface of a first magnet in the array is different from the angle subtended by the arc of the outer surface of a second magnet in the array. In some embodiments, at least one of the angles is greater than a threshold value, and at least one of the angles is less than the threshold value. The threshold value is equal to 360°/n, where n is the number of magnets in the array. So for a Halbach array comprised of 8 magnets, the threshold value is 45°, for 16 magnets the threshold value is 22.5°, and for 24 magnets the threshold value is 15°. In some embodiments, all axial magnetized magnets have different angles subtended by their arcs than all circumferential magnetized magnets. In some embodiments, all axial magnetized magnets have larger angles subtended by their arcs than all circumferential magnetized magnets. In some embodiments, all axial magnetized magnets have smaller angles subtended by their arcs than all circumferential magnetized magnets.
[0069] In some embodiments, the angle for the circumferential magnetized magnets or the axial magnetized magnets (but not both) is less than 40°. In some embodiments, the angle is less than 30°. In some embodiments, the angle is less than 20°. In some embodiments, the angle is less than 10°.
[0070] The outer surface 402 that forms an arc also has a maximum arc length 408 (i.e., the longest arc length of an outer surface that can be formed by a plane orthogonal to the axis of rotation) that can vary from magnet to magnet. In preferred embodiments, the arc length of each magnet in the array is between 1 mm and 5 mm. In some embodiments, the arc length of each magnet in the array is between 1 mm and 4 mm or between 1 mm and 3 mm. In some embodiments, the arc length of each magnet in the array is between 2 and 3 mm. In the most preferred embodiments using the second technique, the maximum arc length of at least one axial magnetized magnet is different from the maximum arc length of at least one circumferential magnetized magnet.
[0071] The proximal surface 406 of each magnet will have a surface area. In preferred embodiments, the surface area of at least one axial magnetized magnet is different from the surface area of at least one circumferential magnetized magnet.
[0072] In the most preferred embodiments, each axial magnetized magnet either (a) has a larger maximum arc length and a larger surface area than each circumferential magnetized magnet, or (b) has a smaller maximum arc length and a smaller surface area than each circumferential magnetized magnet.
[0073] Each magnet 401 also has an axial length 409 (i.e., the distance between the most proximal point of the magnet and the most distal point of the magnet). In some embodiments, the axial length of at least one axial magnetized magnet is different from the axial length of at least one circumferential magnetized magnet.
[0074] When arranged in the modified Halbach array, the array will have a substantially cylindrical cross-section. The maximum outer diameter of the modified Halbach array is generally less than 7 mm, such as <6.75 mm, or <6.5 mm. In this configuration, the inner surfaces of each magnet will form an opening that may extend at least partially through the modified Halbach array, and preferably extends through the entire modified Halbach array. The opening will generally have a diameter of between 0.5 mm and 2 mm. Thus, the inner surface 407 of each magnet is typically a distance 410 from the axis of rotation 499 that is between 0.25 mm and 1 mm.
[0075] Additionally, each side surface 403, 404 will have a length that extends between an inner surface and an outer surface. In
[0076] Skilled artisans will recognize that some all of these differences in physical dimensions may be combined in a single array. For example, in some embodiments, both the arc length and axial length may differ between axial magnetized magnets and circumferential magnetized magnets.
[0077] Referring to
[0078] In
[0079]
[0080] In preferred embodiments, each side surface will not be configured to be substantially normal to the outer surface; an imaginary plane extending along each flat side surface of a given magnet would not intersect the angle of rotation.
[0081] In
[0082] The modified Halbach array has angles 445, 455 subtended by the arcs of the outer surfaces 442, 442 by the axis of rotation 499. It should be recognized that it is possible for, e.g., angle 405 (from
[0083] In
[0084] Skilled artisans will recognize that these variations may be combined in various embodiments. For example, as seen in
[0085] In
[0086] Third Modification Approach
[0087] The third modification approach combines the first and second modification approaches.
[0088] That is, in addition to manipulating the axial positioning of the proximal surfaces as accomplished by the first modification technique, it also includes adjusting physical dimensions of the magnets as well.
[0089] For example,
[0090] In
[0091]
[0092] In addition, other modifications may be made. For example, in some embodiments, at least one secondary blade is provided on a proximal surface of at least one circumferential magnetized magnet, which extends axially in a proximal direction.
[0093] A view of the proximal surfaces of an embodiment of a Halbach array is shown in
[0094] The cross-sectional shape of the blade may vary in the radial and/or axial direction. For example, in some embodiments, each blade 605 tapers slightly in the radial direction, as the blade extends away from the axis of rotation 699. In some embodiments, each blade 605 tapers slightly in the axial direction, as the blade extends away from the proximal surface 604 of a circumferential magnetized magnet 602. In some embodiments, the blade tapers in both the radial direction and axial direction. In some embodiments, the proximal surface 606 is angled such that a portion 607 of the proximal surface 606 of the blade 605 that is closest to the axis of rotation is further from the proximal surface 604 of the circumferential magnetized magnet than a portion 608 of the proximal surface 606 of the blade 605 that is further from the axis of rotation 699. Said differently, the height of the blade 605 at a portion 607 close to the axis of rotation 699 is greater than the height of the blade 605 at the portion 608 that is radially further from the axis of rotation.
[0095] The general cross-sectional shapes of the blades may vary significantly as desired. For example, while each blade may be generally rectangular, other blades may have curved shapes, trapezoidal or triangular shapes, oval shapes, or even geometric stadium shapes.
[0096] In preferred embodiments, each blade has the same shape, but in some embodiments, one or more blades may vary in shape.
[0097] Further, in some embodiments, if secondary blades are utilized, the number of secondary blades on each circumferential magnetized magnet is preferably identical. However, in other embodiments, each circumferential magnetized magnet may independently have 0, 1, 2, or 3 blades.
[0098]
[0099] It should be recognized that having blades which are radially offset from an inner and/or outer surface of a magnet is not required, although in preferred embodiments, any blades are radially offset from at least the inner surface. When blades are offset from an inner and/or outer surface, any radial offset distance is preferably less than 25% of the radial length of the proximal surface of the magnet, and is typically 1 mm or less.
[0100]
[0101]
[0102] The use of these secondary blades, and the contouring or shaping of the proximal surface of the magnets, may be configured to reduce the axial forces on one or more bearings. As will be understood, more force on a bearing increases the heat generated by the rotation due to, e.g., frictional forces. Beyond increased wear-and-tear on the pump, the heat transfer to blood may lead to further complications. Therefore, in some embodiments, the proximal surface of the magnets are either contoured or contain one or more secondary blades, which may be configured to reduce the axial load on one or more bearings. In some embodiments, there is greater reduction in the load at higher rotational speeds.
[0103] Referring to
[0104] If the blood pump 700 is intended to be used in long term applications, i.e., in situations in which the blood pump 700 is implanted into the patient for several weeks or even months, electric power is preferably supplied by means of a battery. This allows a patient to be mobile because the patient is not connected to a base station by means of cables. The battery can be carried by the patient and may supply electric energy to the blood pump 700, e.g., wirelessly.
[0105] The blood is conveyed along a passage 744 connecting the blood flow inlet 741 and the blood flow outlet 742 (blood flow indicated by arrows). Rotor 711 as described above is provided for conveying blood along the passage 744 and is mounted to be rotatable about an axis of rotation 705 within the pump casing 702 by means of a first bearing 731 and a second bearing 732. The axis of rotation 705 is preferably the longitudinal axis of the impeller 711. Both bearings 731, 732 are contact-type bearings in this embodiment. At least one of the bearings 731, 732 could be a non-contact-type bearing, however, such as a magnetic or hydrodynamic bearing. The first bearing 731 is a pivot bearing having spherical bearing surfaces that allow for rotational movement as well as pivoting movement to some degree. A pin 733 is provided, forming one of the bearing surfaces. The second bearing 732 is disposed in a supporting member 713 to stabilize the rotation of the impeller 711, the supporting member 713 having at least one opening 714 for the blood flow. Blades 715 are provided on the rotor 711 for conveying blood once the rotor 711 rotates. Rotation of the rotor 711 is caused by the drive unit 750 which is magnetically coupled to a magnet 731 at the proximal end of rotor 711. The illustrated blood pump 700 is a mixed-type blood pump, with the major direction of flow being axial. It will be appreciated that the blood pump 700 could also be a purely axial blood pump, depending on the arrangement of the rotor 711, and in particular the blades 715.
[0106] Skilled artisans will recognize how to configure an electric drive unit to be capable of magnetically interacting with said intravascular blood pump rotor. 101061 to be capable of working with the disclosed rotor. The electric drive unit should be configured to be adjacent to, but physically separated from, the rotor 711. In preferred embodiments, the electric drive unit comprises or consists essentially of a 2-, 4-, or 6-pole stator.
[0107]
[0108] The posts 850 are sequentially controlled by a control unit (not shown) in order to create a rotating magnetic field for driving the blood pump 800. The magnet 821 is arranged to interact with the rotating magnetic field so as to cause rotation of the rotor 811 about the axis of rotation 805. Coil windings are arranged about the shaft portions 851 of the posts 850. The posts 850 are arranged parallel to the axis of rotation 805, more specifically, a longitudinal axis of each of the posts 850 is parallel to the axis of rotation 805.
[0109] In order to close the magnetic flux path, a back plate 859 is typically used. The back plate 859 is located at the end of the shaft portions 851 opposite the head portions 852. The posts 850 act as a magnetic core and are made of a suitable material, in particular a soft magnetic material, such as steel or a suitable alloy, in particular cobalt steel. Likewise, the back plate 859 is made of a suitable soft magnetic material, such as cobalt steel. The back plate 859 enhances the magnetic flux, which allows for reduction of the overall diameter of the blood pump 800, which is important for intravascular blood pumps. Due to the use of the modified Halbach array, no magnetic yoke on the other side of the rotor magnets 821 is required.
[0110]
[0111] Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the present disclosure described herein. Such equivalents are intended to be encompassed by the following claims