Abstract
A centrifugal blood pump without a mechanical bearing comprises a pump casing (1), an impeller (9) arranged in the pump casing rotatably about the central axis and freely movable axially and radially within a limited clearance. The impeller has per-manent magnets or permanently magnetized magnetic regions (N/S) which cooperate with an electromagnetic drive to set the impeller rotating. A circular wall (12) or circularly arranged wall sections are provided within the pump casing, their inner surfaces defining a radial clearance together with the outer circumference of the impeller to form a hydrodynamic radial bearing for the impeller.
Claims
1.-37. (canceled)
38. A centrifugal blood pump without a mechanical bearing, comprising: a pump casing with a central axis, a blood flow inlet disposed on the central axis and a blood flow outlet disposed on a circumference of the pump casing, an impeller arranged in the pump casing so as to be rotatable about the central axis and freely moveable axially and radially within a limited axial clearance and limited radial clearance, the impeller being provided with permanent magnets or permanently magnetized magnetic regions and further with radially extending blades defining passages therebetween for radial blood flow, and an electromagnetic drive adapted to cooperate with the permanent magnets or the permanently magnetized magnetic regions of the impeller so as to set the impeller rotating about the central axis, wherein the radial clearance is 100 μm or less so as to form a hydrodynamic radial bearing for the impeller and the radial clearance is defined by an outer circumference of the impeller and an inner surface of a plurality of wall sections comprising an upper circular wall section and a lower circular wall section, the upper circular wall section and the lower circular wall section being axially spaced apart so as to form a continuous circumferential through opening for blood to flow from the impeller towards the blood flow outlet.
39. The centrifugal blood pump according to claim 38, wherein a cross-section of the continuous circumferential through opening increases in a radially outward direction.
40. The centrifugal blood pump according to claim 38, wherein the electromagnetic drive comprises a plurality of coils without a ferromagnetic core, the coils being arranged in a plane axially spaced from the impeller.
41. The centrifugal blood pump according to claim 38, wherein the electromagnetic drive comprises a plurality of coils arranged in a plane axially spaced from the impeller on both sides of the impeller.
42. The centrifugal blood pump according to claim 40, wherein the coils are potted in a polymer matrix.
43. The centrifugal blood pump according to claim 40, wherein the coils are directly or indirectly mounted on a ceramic plate so as to form an integral component therewith, the ceramic plate limiting the axial clearance.
44. The centrifugal blood pump according to claim 38, wherein the radial clearance is 50 μm or less.
45. The centrifugal blood pump according to claim 38, wherein the impeller comprises a first disc and a second disc which are axially spaced apart, each disc having magnetic regions and a central opening arranged for axial blood flow through the first disc and the second disc, the blades of the impeller being arranged between the first disc and the second disc.
46. The centrifugal blood pump according to claim 45, wherein the blades of the impeller are integrally connected by at least one circular rim axially extending from an axial side or both axial sides of the blades and surrounding an outer circumference of at least one or both of the first disc and the second disc, the circular rim forming a part or all of the outer circumference of the impeller.
47. The centrifugal blood pump according to claim 45, wherein at least one or both of the first disc and the second disc have a circular outer circumference which forms a part or all of the outer circumference of the impeller.
48. The centrifugal blood pump according to claim 45, wherein surfaces of the first and second discs which axially face away from each other are planar and are each axially spaced from an adjacent planar wall so as to allow blood to flow between the planar disc surfaces and the adjacent planar walls.
49. The centrifugal blood pump according to claim 45, wherein surfaces of the first and second discs which axially face away from each other are each axially spaced from an adjacent wall provided by or arranged in the pump casing so as to allow blood to flow between the surfaces of the first and second discs and the adjacent walls, whereby one or both of the surfaces of the first and second discs and/or one or both of the adjacent walls provide ramps extending about the central axis in a circumferential direction so as to create a hydrodynamic axial force lifting the impeller from the respective adjacent wall upon rotation of the impeller.
50. The centrifugal blood pump according to claim 38, wherein the impeller comprises a disc with a central opening arranged for axial blood flow through the disc and wherein the blades of the impeller extend axially from both axial sides of the disc and are formed as magnets or have magnetic regions.
51. The centrifugal blood pump according to claim 45, wherein the disc has a circular radially outer surface and wherein the wall extends radially inward so as to form together with the circular radially outer surface of the disc the hydrodynamic radial bearing.
52. The centrifugal blood pump according to claim 45, wherein the blades of the impeller have upper and lower surfaces axially spaced from adjacent walls provided by or arranged in the pump casing so as to allow blood to flow between the upper and lower surfaces and the adjacent walls, either or both of the upper and lower surfaces providing a plurality of ramps extending about the central axis in a circumferential direction so as to create a hydrodynamic axial force lifting the impeller from the respective adjacent wall upon rotation of the impeller.
53. The centrifugal blood pump according to claim 52, wherein the plurality of ramps of one or more of the upper and lower surfaces of the blades of the impeller is formed by a curved or tapered leading edge of the blades, as seen in a direction of rotation of the impeller.
54. The centrifugal blood pump according to claim 45, wherein the disc has a plurality of circularly arranged axial through openings and wherein the blades are inserted through the circularly arranged through openings so as to extend from one axial side of the disc to the other axial side thereof.
55. The centrifugal blood pump according to claim 54, wherein the disc comprises or is entirely made up of a polymer material.
56. The centrifugal blood pump according to claim 45, wherein the disc and the blades are composed of two semi-shells within which the magnets or magnetic regions are housed.
57. The centrifugal blood pump according to claim 38, wherein the blades of the impeller are formed together as an integral injection moulded piece.
58. The centrifugal blood pump according to claim 45, wherein the first disc, the second disc, and the blades of the impeller are made of magnetized ferromagnetic material.
59. The centrifugal blood pump according to claim 45, wherein the first disc, the second disc and the blades of the impeller are formed as an integral piece of ferromagnetic material, the integral piece being magnetized.
60. The centrifugal blood pump according to claim 38, wherein the radial dimension of at least one or all of the blades of the impeller increases circumferentially, radially outer surfaces of these blades forming part or all of the outer circumference of the impeller.
61. The centrifugal blood pump according to claim 38, wherein the blades of the impeller have a leading surface, as seen in a direction of rotation of the impeller, which is convex with respect to its radial extension.
62. The centrifugal blood pump according to claim 38, wherein the blades of the impeller have an axially extending leading edge, as seen in a direction of rotation of the impeller, which is curved or tapered.
63. The centrifugal blood pump according to claim 38, wherein the impeller has an aspect ratio from 4:1 (diameter:height) to 6:1.
64. The centrifugal blood pump according to claim 38, wherein a first magnet or magnetic region and a second magnet or magnetic region, each having a north pole and a south pole, are combined in one impeller blade, with the north and south poles of the first magnet or magnetic region being arranged upside down with respect to the north and south poles of the second magnet or magnetic region.
65. The centrifugal blood pump according to claim 38, wherein the magnets or magnetic regions have a coating all over that is a polymer or a metal.
66. The centrifugal blood pump according to claim 65, wherein the metal is titanium or a biocompatible precious metal and the coating has a thickness of no more than 50 μm.
67. The centrifugal blood pump according to claim 38, wherein the blood flow outlet is tangentially disposed on a circumference of the pump casing.
68. The centrifugal blood pump according to claim 38, comprising a ring diffuser arranged peripherally of the wall.
69. The centrifugal blood pump according to claim 38, wherein the radial clearance is 20 μm or less.
70. The centrifugal blood pump according to claim 38, wherein the continuous circumferential through opening is in the form of a ring-like opening increasing in a radially outward direction.
71. The centrifugal blood pump according to claim 70, wherein an opening angle of the ring-like through opening does not exceed 7°.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] Preferred embodiments of the invention will hereinafter be described in more detail with reference to the accompanying drawings, in which:
[0043] FIG. 1 shows a perspective view of a blood pump according to a first embodiment of the invention,
[0044] FIG. 2 shows the blood pump as shown in FIG. 1 without the upper set of electromagnetic coils and the planar ceramic surface,
[0045] FIG. 3 shows the blood pump as shown in FIG. 2 without the impeller,
[0046] FIG. 4 shows the blood pump as shown in FIG. 2 without the upper pump housing shell and without the upper magnetic disc of the impeller,
[0047] FIG. 5 shows an alternative upper pump housing shell upside down, having a wall without hydrodynamic pockets,
[0048] FIG. 6 shows the lower pump housing shell of the blood pump with the lower set of electromagnetic coils arranged on a thin ceramic disc,
[0049] FIG. 7 shows a cross sectional view of the blood pump of FIG. 1,
[0050] FIG. 8 shows the blade rotor of the impeller of the blood pump of FIG. 1,
[0051] FIG. 9 shows a first alternative blade rotor,
[0052] FIG. 10 shows a second alternative blade rotor,
[0053] FIG. 11 shows a third alternative blade rotor,
[0054] FIG. 12 shows an alternative impeller for the blood pump of FIG. 1 entirely made of ferromagnetic material,
[0055] FIG. 13 schematically shows top views of various blade rotor forms,
[0056] FIG. 14 shows a first variant of an impeller of a second embodiment of the blood pump,
[0057] FIG. 15 shows a second variant of the impeller of the second embodiment,
[0058] FIG. 16 shows a third variant of the impeller of the second embodiment,
[0059] FIG. 17 shows a fourth variant of the impeller of the second embodiment,
[0060] FIG. 18 shows an alternative upper pump housing shell upside down, similar to that of FIG. 5, having a wall with a sufficient thickness such that the openings may serve as a diffuser, and
[0061] FIG. 19 shows a cross sectional view of the wall of the upper pump housing shown in FIG. 18.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0062] FIG. 1 shows a first embodiment of a centrifugal blood pump with a casing 1 comprising an upper shell 2 and a lower shell 3. The upper shell 2 as well as the lower shell 3 each have a circular recess 4 accommodating a set of six electromagnetic coils 5 therein. The number of coils can be different and is preferably dividable by three. The coils 5 do not have any ferromagnetic core. Preferably, they have an oval shape and may alternatively have a trapezoidal shape, so as to fully exploit the available space within the recess 4. The coils 5 are encapsulated in a polymer matrix directly on a very thin circular ceramic plate 6 having a thickness of only about 100 μm. The ceramic plate 6 has a central hole 7 constituting a blood flow inlet through which blood can enter the blood pump when the blood pump is appropriately connected e.g. to the apex of the left ventricle. The blood will exit the blood pump through the blood flow outlet 21. The ceramic plate 6 with the electromagnetic coils 5 mounted thereon together form a unitary coil assembly.
[0063] FIG. 2 shows the blood pump of FIG. 1 without the coil assembly 5, 6. As can be seen, the recess 4 in the upper shell 2 of the pump casing 1 has a ledge 8 on which the ceramic plate 6 rests. The ledge 8 defines a step or further recess within the recess 4, within which the impeller 9 is accommodated so that it can rotate about a central axis of the pump casing 1. The impeller 9 comprises an upper magnetic disc 10 and a lower magnetic disc (not shown) and further a blade rotor 11 sandwiched between the two magnetic discs 10. The upper and lower surfaces of the impeller 9 and the axially inner surfaces of the upper and lower ceramic plates 6 of the two coil assemblies define a limited axial clearance within which the impeller 9 is freely axially movable. The radially outer circumference of the impeller 9 together with the lower inner surface of the stepped recess 4 define a radial clearance within which the impeller 9 is freely radially movable.
[0064] The lower wall 12 of the recess 4 limiting the radial clearance for the impeller 9 can be seen better in FIG. 3. The wall 12 is free-standing and has through openings 13 through which blood being radially propelled by the impeller can pass into a ring diffuser 20 (FIG. 4) arranged peripherally of the wall 12. Instead of the wall 12 having through openings 13, the wall may alternatively be composed of axially extending, spaced apart wall sections providing through openings therebetween.
[0065] The wall 12 is further provided with pockets 14 which are configured to enhance a hydrodynamic radial bearing effect on the impeller 9, when the impeller rotates about the pump casing's central axis. In the wall sections of the pockets 14, the radial clearance defined between the impeller's 9 outer circumference and the inner surface of the wall 12 radially converges, as seen in the direction of rotation of the impeller, which is indicated in FIG. 3 by an arrow.
[0066] FIG. 4 shows the lower shell 3 with the blade rotor 11, the upper and lower magnetic discs 10 of the impeller 9 being removed. As can be seen, the blade rotor 11 has three radially extending blades 15 held together by a central circular ring 16 and two upper and lower circumferential rings 17, 18. Passages 19 are defined between the blades 15 for blood to flow radially from a blood flow inlet, corresponding to the central hole 7, to the ring diffuser 20 arranged peripherally of the blade rotor 11 and further to a blood flow outlet 21 of the pump casing. Upon rotation of the impeller 9, the upper and lower circumferential rings 17, 18 will slide along the wall 12, namely above and below the wall's 12 through openings 13, whereas the radially outer surfaces 22 of the blade 15 and the passages 19 defined there-between will pass along the through openings 13 of the wall 12 (see FIG. 3). The distances between two adjacent through openings 13 in the wall 12 (or between corresponding axially extending wall sections) are dimensioned so that they are smaller than all distances between the radially outer ends of the blades 15 of the blade rotor 11. In this way, pulsation of the blood flow through the impeller 9 can be avoided, as the blood flow passages of the impeller are always open in a radially outward direction.
[0067] FIG. 5 shows an alternative upper shell 2′ which differs from the upper shell 2 in FIG. 3 in that it has a larger number of through openings 13 and, more importantly, the inner surface of the wall 12 lacks pockets 14. A hydrodynamic radial bearing will nevertheless be established once the impeller 9 is set rotating. Alternatively (not shown), the wall 12 may be divided into an upper circular wall section forming part of the upper shell 2 and a lower circular wall section of the lower shell 3, each wall section preferably being provided with the afore-mentioned pockets 14, a continuous circular through opening 13 being formed between the two circular wall sections.
[0068] FIG. 6 shows the lower shell 3 of the pump casing 1 with only the lower coil assembly 5, 6 positioned in a recess (not shown) of the lower shell 3. The central opening 7 in the coil assembly 5, 6 can be provided on one or both coil assemblies, thus allowing axial blood inflow from only one side or on both sides of the impeller.
[0069] FIG. 7 shows a cross-sectional view of the blood pump described above with all elements accordingly numbered. As can be seen, the upper and lower coil assemblies 5, 6 are identical in size and structure. The lower ceramic plate 6 can be supported on the free end of the wall 12 of the upper shell 2. The blade rotor 11 of the impeller 9 carrying a magnetic disc 10 on each side, as shown in the cross-sectional view in FIG. 7, is cut at one side through a blade 15 and at the other side through a passage 19 defined between two blades 15. As further becomes apparent from the cross-sectional view in FIG. 7, the cross section of the ring diffuser 20 increases in the circumferential direction of the blood pump in this embodiment.
[0070] Upon rotation of the impeller 9, blood flows radially through the passages 19 and also above and below the impeller's 9 magnetic discs 10 between the discs 10 and the ceramic plates 6. Their mutual contact surfaces are planar. Alternatively, one or both of these surfaces may have ramps extending in a circumferential direction so as to create a hydrodynamic lifting effect on the impeller. Although the lower ceramic plate 6 is shown as having a central hole, similar to the central hole 7 of the upper ceramic plate 6, the lower ceramic plate 6 preferably has no central hole but completely seals against blood leakage.
[0071] FIG. 8 shows the blade rotor 11 separately, including the blades 15 and their radially outer surfaces 22, the through openings 13 defined between the blades 15, the central circular ring 16 as well as the upper and lower circumferential outer rings 17 and 18 connecting the blades 15 to form an integral piece, which is preferably injection molded. The blades 15 of the impeller 9 have an axially extending leading edge 23, as seen in the direction of rotation of the impeller, which is curved or tapered in order to enhance the hydrodynamic effect of the radially outer surfaces 22 and reduce blood damage. The number of blades 15 can be more than three, e.g. four, five or six. Likewise, the angular extension a of the blades may be larger or smaller than shown in FIG. 8. Also, the inner diameter of the blades may be larger or smaller than shown in FIG. 8.
[0072] FIGS. 9, 10 and 11 show a first, a second and a third variant of the blade rotor 11. The blade rotor 11 in FIG. 9 differs from the blade rotor 11 in FIG. 8 in that the upper and lower circumferential rings 17, 18 are interrupted. The hydrodynamic radial bearing for the impeller 9 is achieved with this variant of the blade rotor 11 mainly by the radially outer surfaces 22 of the blades 15. Alternatively, the magnetic disc 10 (not shown in FIG. 9) may be formed such that it fills the space of the missing sections of the upper and lower circumferential rings 17, 18. Here, too, it is advantageous if the blades 15 of the impeller have an axially extending leading edge, as seen in the direction of rotation of the impeller, which is curved or tapered in order to increase the hydrodynamic effect for the hydrodynamic radial bearing of the impeller and in order to reduce blood damage.
[0073] FIG. 10 shows a second variant of the blade rotor 11 in which the blades 15 are formed as straight bars, so that the passages 19 defined between adjacent blades 15 are accordingly increased.
[0074] The blade rotor 11 in FIG. 11 is formed from a polymeric washer-like disc having a number of radially extending passages 19 which may overlap in a central area of the blade rotor 11. The radial passages 19 may have a constant cross section or, as shown at 19.1, may have a cross section which increases towards the outer circumference.
[0075] In the embodiments described so far and in all variants thereof, the magnetic discs 10 are magnetized in sections in opposite directions. Each section has a first pole at the upper side of the disc and the respective opposite pole on the lower side of the disc. The number of magnetized sections is preferably eight but may likewise be four or twelve and should be different from the number of coils 5. Furthermore, instead of the upper and lower circumferential rings 17, 18, the radial dimensions of the circular magnetic discs 10 may be such that the outer circumferential radial surfaces of the magnetic discs replace the upper and lower circumferential rings 17, 18. In this case, the blades 15 are interconnected only by the central circular ring 16. The advantage is that more magnetic material is present, so that the maximum torque provided by the impeller may accordingly be increased.
[0076] FIG. 12 shows a further variant of an impeller that can be used in connection with the blood pump according to the first embodiment. Here the impeller is entirely made from permanently magnetized ferromagnetic material, i.e. not only the upper and lower magnetic discs 10 but also the radially extending blades 15 are magnetic. Again, the blades 15 have an axially extending leading edge 23, as seen in the direction of rotation of the impeller, which is curved or tapered in order to reduce blood damage. To reduce the likelihood of corrosion and increase the hemo-compatibility, the rotor may be encapsulated or shielded by a polymeric or metal housing. The encapsulation can be provided in a polymeric molding process or by galvanic metal deposition.
[0077] The blade rotor 11 may have more than three blades 15, and the form of the blades 15 need not be triangular or trapezoidal or straight. FIG. 13 schematically shows top views of various blade rotor forms. Among these forms, blade rotors with curved blades are preferred. It is particularly preferred when the leading surface 22b of the impeller blades 15, as seen in the direction of rotation of the impeller, is convex with respect to its radial extension.
[0078] FIG. 14 shows a first variant of an impeller 9 of a second embodiment of a blood pump. The pump casing 1, upper shell 2, lower shell 3, recesses 4, coil assemblies comprising the coils 5 and ceramic plates 6, wall 12 or wall sections within the pump casing 1, through openings 13 extending through the wall 12 or between corresponding wall sections, ring diffuser 20 and blood flow outlet 21 in the second embodiment are identical to those of the first embodiment described above. The only difference in the second embodiment is the impeller 9, which comprises only one disc 10 with a central opening 7, rather than two magnetic discs 10. The disc 10 in the second embodiment is centrally arranged, as seen in an axial direction, and may or may not be magnetic. The blades 15 of the impeller 9 extend axially from both axial sides of the disc 10 and are formed as magnets or may have magnetic regions. Blood flow passages 19 are defined between adjacent blades 15.
[0079] In addition, in a variant of the second embodiment, the wall 12 or wall sections arranged within the pump casing may be formed as a radially inward extending wall arranged horizontally, so as to form together with the circular radially outer surface of the central disc 10 the afore-described hydrodynamic radial bearing.
[0080] In the first variant of the second embodiment shown in FIG. 14, both the blades 15 and the disc 10 of the impeller 9 are made from magnetized material. The borders between adjacent magnetized regions are indicated by dotted lines. The direction of rotation of the impeller 9 is indicated by an arrow. Here again, the axially extending leading edges of the blades 15 are rounded or tapered so as to enhance the radial hydrodynamic bearing effect and reduce blood damage. In addition, the horizontal leading edges 24 of the blades 15 are also rounded or tapered to enhance the axial hydrodynamic bearing effect and reduce blood damage. Further in addition, although not easy to recognize from the drawing, the upper and lower axial surfaces 25 of the blades are slightly tapered so as to provide a circumferentially extending ramp to create a hydrodynamic axial force lifting the impeller from the respective adjacent wall (not shown) upon rotation of the impeller. Similarly, as has already been explained in connection with the first embodiment, the radially outer surfaces 22 of the blades 15 may likewise change from a smaller radius to a larger radius, as seen in the direction of rotation of the impeller, so as to form, together with the circular wall 12 or circularly arranged wall sections in the pump casing 1, radially converging clearance sections, so as to enhance the radial hydrodynamic bearing effect on the impeller.
[0081] FIG. 15 shows a second variant of the impeller 9 similar to that shown in FIG. 14, except that the disc 10 and the blades 15 are composed of two semi-shells 26, 27 within which the magnets are housed. The semi-shells 26, 27 may be injection molded.
[0082] FIG. 16 shows a third variant of the impeller 9 of the second embodiment, similar to the variant shown in FIG. 15. Here, two magnets are housed within each of the blades 15, the alternation of the north and south poles of the respective magnets being indicated with N and S. Again, alternatively both the blades 15 and the disc 10 may be integrally formed from ferromagnetic material and magnetized in sections, as described above in relation to FIG. 14.
[0083] Finally, a fourth variant of the impeller 9 of the second embodiment is shown in FIG. 17. This variant is similar to the variant shown in FIG. 14, except that the disc 10 is not necessarily made from a magnetized material. Here the disc 10 may instead be made of a polymer and has a plurality of circularly arranged axial through openings into which the blades 15 are inserted so that they extend from one axial side of the disc 10 to the other axial side thereof.
[0084] In all variants of the second embodiment described above, the blades 15 may have a different axial cross section, similar to one of those schematically shown in FIG. 13. However, since only the upper and lower axial surfaces of the blades 15 contribute to the hydrodynamic axial bearing in the second embodiment, blades 15 with a large axial cross section are preferred.
[0085] FIG. 18 shows an alternative upper shell 2″ which differs from the upper shell 2′ in FIG. 5 in that the free-standing wall 12 has a greater thickness and the openings 13 are diverging in a radially outward direction. Alternatively (not shown), the free-standing wall 12 may be divided into an upper circular wall section forming part of the upper shell 2 and a lower circular wall section of the lower shell 3, a continuous circular through opening being formed between the two circular wall sections. The continuous circular through opening also may have a diverging or increasing cross-section in a radial outward direction. The increasing cross section is illustrated in FIG. 19 showing a cross sectional view of the wall of FIG. 18 in an axial direction. The blood flows in the direction of the arrow. It is noted that, in case a wall with circumferentially spaced apart openings 13 is provided, the openings preferably also diverge as seen in a radial cross-sectional view. The opening angle is 7° or less in order to avoid detachment of the flow. In this variant the openings 13 or the circular opening serve as a first diffuser providing a pressure increase, i.e. an additional pump effect. The first diffuser may also stabilize the radial hydrodynamic bearing of the impeller by keeping the pressure along the circumference of the impeller constant. For this purpose, the deceleration of the blood in the first diffuser may either be constant or may vary along the circumference of the circular wall 12, for instance by varying the height, width and/or diameter of the openings 13 and/or the wall thickness (i.e., the length of the openings 13).
