IMPELLER FOR AN IMPLANTABLE, VASCULAR SUPPORT SYSTEM

20240102475 ยท 2024-03-28

    Inventors

    Cpc classification

    International classification

    Abstract

    The invention relates to an impeller (1) for an implantable, vascular support system (2), at least comprising: an impeller body (3) having a first longitudinal portion (4) and a second longitudinal portion (5); at least one blade (6) formed in the first longitudinal portion (4) and designed to axially convey a fluid by means of a rotational movement; at least one magnet (7) provided and encapsulated in the second longitudinal portion (5).

    Claims

    1.-10. (canceled)

    11. A method for producing an impeller for a cardiac support system, the method comprising: encapsulating at least one magnet in a second longitudinal portion of an impeller body of the impeller, wherein the impeller body further comprises a first longitudinal portion comprising at least one blade configured to axially convey a fluid by a rotational movement, wherein the second longitudinal portion comprises a first rotor extending axially configured to form a radial magnetic coupling with a second axially-extending rotor comprising at least one magnet, the radial magnetic coupling comprising an axial force between the first and second rotors.

    12. The method according to claim 11, wherein the at least one magnet of the second longitudinal portion of the impeller and the at least one magnet of the second rotor are configured to partially axially overlap and to be partially axially offset when assembled together.

    13. The method according to claim 11, wherein the at least one magnet of the second longitudinal portion of the impeller and the at least one magnet of the second rotor are configured to be entirely radially offset when assembled together.

    14. The method according to claim 11, wherein the impeller body is a single piece.

    15. The method according to claim 11, wherein the impeller body comprises multiple pieces.

    16. The method according to claim 11, wherein the second longitudinal portion further comprises a magnetic return.

    17. The method according to claim 11, wherein encapsulating the at least one magnet comprises encapsulating the at least one magnet of the second longitudinal portion of the impeller with a cover.

    18. The method according to claim 11, wherein the second rotor is configured to be positioned at least partially in a cavity of the impeller body.

    19. The method according to claim 11, wherein the at least one magnet of the second longitudinal portion of the impeller comprises a plurality of magnets offset from one another axially.

    20. The method according to claim 11, wherein the at least one magnet of the second rotor comprises a plurality of magnets offset from one another axially.

    21. The method according to claim 11, wherein the second longitudinal portion of the impeller comprises a cylindrical shape.

    22. The method according to claim 11, further comprising assembling the first and second rotors together to form the radial magnetic coupling.

    23. The method according to claim 11, further comprising: disposing the second longitudinal portion of the impeller in a proximal direction with respect to the first longitudinal portion of the impeller; and partially axially offsetting the at least one magnet of the second rotor in the proximal direction with respect to the at least one magnet of the second longitudinal portion of the impeller.

    24. An impeller for a cardiac support system, the impeller comprising: an impeller body comprising: a first longitudinal portion comprising at least one blade configured to axially convey a fluid by a rotational movement; and a second longitudinal portion comprising a magnet mount, the magnet mount comprising at least one recess that extends inward from an outer surface of the second longitudinal portion and configured to receive at least one magnet.

    25. The impeller according to claim 24, wherein the second longitudinal portion is configured to receive a plurality of magnets offset from one another axially.

    26. The impeller according to claim 24, wherein the second longitudinal portion comprises a cylindrical shape.

    27. The impeller according to claim 24, further comprising said at least one magnet disposed within the at least one recess of the magnet mount.

    28. The impeller according to claim 24, wherein the at least one recess is further configured to receive a magnet assembly comprising said at least one magnet and a magnetic return.

    29. The impeller according to claim 24, wherein the at least one recess extends axially inward from an end face of the second longitudinal portion that faces away from the first longitudinal portion.

    30. The impeller according to claim 24, wherein the second longitudinal portion further comprises a cover configured to hermetically seal said at least one recess and encapsulate said at least one magnet.

    31. The impeller according to claim 24, wherein the at least one recess extends radially inward from the outer surface of the second longitudinal portion.

    32. The impeller according to claim 24, wherein the impeller is sized to be located within a cardiac support system having an outer diameter in the range of 4 mm to 10 mm.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0057] The solution presented here as well as its technical environment are explained in more detail below with reference to the figures. It is important to note that the invention is not intended to be limited by the design examples shown. In particular, unless explicitly stated otherwise, it is also possible to extract partial aspects of the facts explained in the figures and to combine them with other components and/or insights from other figures and/or the present description.

    [0058] The figures show schematically:

    [0059] FIG. 1: a here proposed impeller in an impeller housing,

    [0060] FIG. 2: another here proposed impeller in an impeller housing,

    [0061] FIG. 3: a here proposed impeller,

    [0062] FIG. 4: a sectional view of another here proposed impeller,

    [0063] FIG. 5: a sequence of a here proposed method,

    [0064] FIG. 6: a sequence of a further here proposed method,

    [0065] FIG. 7: a sequence of a further here proposed method,

    [0066] FIG. 8: an illustration of a further here proposed method, and

    [0067] FIG. 9: a support system, implanted in a heart.

    DETAILED DESCRIPTION

    [0068] FIG. 1 schematically shows a here proposed impeller 1 in an impeller housing 11. The impeller 1 is suitable for an implantable vascular support system (not shown here, see FIG. 9). The impeller 1 can generally also be used in small axial flow pumps (with impeller), in particular with contactless torque transmission.

    [0069] The impeller 1 comprises an impeller body 3 which is rotatable about an axis of rotation 2 and has a first longitudinal portion 4 which extends in the direction of the axis of rotation 2 and a second longitudinal portion 5 which extends in the direction of the axis of rotation 2. The impeller 1 further comprises at least one blade 6, which is formed in the first longitudinal portion 4 and is configured to axially convey a fluid in the direction of the axis of rotation 2 with a rotational movement. The impeller 1 also comprises at least one magnet 7, which is disposed and encapsulated in the second longitudinal portion 5.

    [0070] In FIG. 1, the impeller body 3 is formed in one piece. For this purpose, the first longitudinal portion 4 and the second longitudinal portion 5 of the impeller body 3 are formed in one piece.

    [0071] FIG. 1 further illustrates that the second longitudinal portion 4 forms a first rotor 12 (outer rotor) for a magnetic coupling 14. The first rotor 12 cooperates (for radial torque transmission) with a second rotor 13 (inner rotor). The second rotor 13 is formed with magnets 7, which are fixedly connected to a drive shaft 15. The first rotor 12 and the second rotor 13 form the magnetic coupling 14. In the embodiment according to FIG. 1, the magnetic coupling 14 is formed in the manner of a radial coupling system.

    [0072] FIG. 2 schematically shows another here proposed impeller 1 in an impeller housing 11. The reference signs are used consistently, so that reference can be made in full to the statements regarding FIG. 1.

    [0073] The impeller body 3 in FIG. 2 is likewise formed in one piece. The design variant according to FIG. 2 differs from the design variant according to FIG. 1 in particular in that the magnetic coupling 14 in FIG. 2 is formed in the manner of an axial coupling system. For this purpose, the first rotor 12 and the second rotor 13 cooperate accordingly (for axial torque transmission).

    [0074] FIG. 1 and FIG. 2 show two fundamental options for transmitting the torque from the motor shaft 15 to the impeller 1 without contact using different magnet system arrangements (radial, axial). The transmittable torque depends in particular on one or more of the following factors: [0075] The larger the magnets, the higher the transmittable torque. The magnet size is limited by the available installation space. [0076] The smaller the distance between the magnet systems (motor shaft and impeller), the higher the transmittable torque. The distance results in particular from the wall thickness of the encapsulation and the various gap dimensions. [0077] Arrangement and/or number of magnetic poles. [0078] Material characteristics, such as energy density, remanence, coercive field strength and/or saturation polarization.

    [0079] FIG. 3 schematically shows a here proposed impeller 1. The reference signs are used consistently, so that reference can be made in full to the statements regarding the preceding figures.

    [0080] FIG. 3 shows an example of a finally assembled impeller 1 for an 8-pole radial coupling in a perspective view. The impeller body 3 in FIG. 3 is likewise formed in one piece.

    [0081] FIG. 4 schematically shows another here proposed impeller 1. The reference signs are used consistently, so that reference can be made in full to the statements regarding the preceding figures.

    [0082] In FIG. 4, the impeller body 3 is formed in multiple parts. For this purpose, the first longitudinal portion 4 and the second longitudinal portion 5 of the impeller body 3 are initially provided as separate or discrete components and then (fixedly) connected to one another to form the impeller body 3.

    [0083] According to the illustration according to FIG. 4, the second longitudinal portion 5 forms a magnet mount 16, in which the at least one magnet 7 is disposed and encapsulated. As an example, the magnet 7 here is a component of a magnet assembly 8, which comprises the magnet 7 and a magnetic return 9. A cover 10, which (hermetically) closes the magnet mount 16, contributes to the encapsulation.

    [0084] FIG. 5 schematically shows a sequence of a here proposed method. The method is used to produce an impeller for an implantable vascular support system. The shown sequence of the method steps a), b) and c) with blocks 110, 120 and 130 is only an example and can be the result of a regular operating sequence. In Block 110, an impeller body is provided, which has a first longitudinal portion and a second longitudinal portion and wherein at least one blade is formed in the first longitudinal portion and configured to axially convey a fluid by means of a rotational movement. In Block 120, at least one magnet is provided. In Block 130, the magnet is disposed and encapsulated in the second longitudinal portion.

    [0085] FIG. 6 schematically shows a sequence of a further here proposed method. The method according to FIG. 6 is based on the sequence shown in FIG. 5, wherein examples of the configurations of the method steps a), b) and c) with blocks 110, 120 and 130 are explained in more detail. The method according to FIG. 6 is used to produce an impeller 1 with a one-piece impeller body 3, which can be driven with radial (contactless) torque transmission.

    [0086] In Block 110, an impeller body is provided with a first longitudinal portion and a second longitudinal portion, wherein at least one blade is formed in the first longitudinal portion and configured to convey a fluid axially with a rotational movement. In other words, it can also be said that, in Block 110, an impeller assembly is provided.

    [0087] For this purpose, a base body is turned and, if necessary, ground in a Block 111. The impeller or the impeller body is subsequently rough turned in a Block 112. Then, in a Block 113, the impeller or the impeller body, in particular the at least one blade, is milled. Subsequently, flushing bores are drilled as an example here in a Block 114. The flushing bores establish a connection between the main blood flow outside and the blood gap inside the impeller and contribute to a continuous exchange of the blood in the gap geometries, in order to prevent thrombus formation and the occurrence of blood damage mechanisms. The bore diameters are advantageously between 0.2 and 0.8 mm. This is an example that, as in Step a), the impeller body can be provided in one piece.

    [0088] In Block 120, at least one magnet is provided. In other words, it can also be said that, in Block 120, a magnet system assembly is provided.

    [0089] For this purpose, the magnets are segmented and magnetized (possibly, even ahead of time) in a Block 121. Furthermore, in a Block 122, a magnetic return is turned and ground. The magnets and the magnetic return are then glued in a Block 123. A sleeve (cover) is subsequently turned in a Block 124. The magnet system is then joined to the sleeve (e.g. by gluing and/or press-fitting) in a Block 125. This is an example that, as in Step b), a magnet assembly can be provided, which comprises the at least one magnet and a magnetic return.

    [0090] In the case of a system without a magnetic return, Blocks 122 and 123 can be omitted.

    [0091] In Block 130, the magnet is disposed and encapsulated in the second longitudinal portion. In other words, it can also be said that, in Block 130, an overall system assembly is provided.

    [0092] For this purpose, the magnetic system (from Block 120) is joined to the impeller or the impeller body (from Block 110) in a Block 131. The magnet or the magnet system is encapsulated with the cover (sleeve). The joints are subsequently welded tight (radially and axially) in a Block 132. The clamping spigot is then removed in a Block 133. The clamping spigot is kept in place until Block 133 for handling reasons.

    [0093] The inner geometry of the impeller body is then turned out in a Block 134. To hollow out the inner geometry by machining, the clamping spigot is first removed (Block 133). The entire system is now held on the welded sleeve. Since the assembly is already assembled, the inner wall thickness (made here of titanium, for example) can also be very thin (wall thickness here approx. 0.1 mm, for example).

    [0094] FIG. 7 schematically shows a sequence of a further here proposed method. The method according to FIG. 7 is based on the sequence shown in FIG. 5, wherein examples of the configurations of the method steps a), b) and c) with blocks 110, 120 and 130 are explained in more detail. The method according to FIG. 7 is used to produce an impeller 1 with a one-piece impeller body 3, which can be driven with axial (contactless) torque transmission.

    [0095] In Block 110, an impeller body is provided with a first longitudinal portion and a second longitudinal portion, wherein at least one blade is formed in the first longitudinal portion and configured to convey a fluid axially with a rotational movement. In other words, it can also be said that, in Block 110, an impeller assembly is provided.

    [0096] For this purpose, the impeller or the impeller body is rough turned in a Block 111. Then, in a Block 112, the impeller or the impeller body, in particular the at least one blade is milled and flushing bores are provided as an example. The flushing bores establish a connection between the main blood flow outside and the blood gap inside the impeller and contribute to a continuous exchange of the blood in the gap geometries, in order to prevent thrombus formation and the occurrence of blood damage mechanisms. The bore diameters are advantageously between 0.2 and 0.8 mm. The impeller body, in particular the second longitudinal portion of the impeller body, is then turned to a magnet diameter in a Block 114.

    [0097] This is an example of how the impeller body can be provided in one piece in Step a).

    [0098] In Block 120, at least one magnet is provided. In other words, it can also be said that, in Block 120, a magnet system assembly is provided.

    [0099] For this purpose, the magnets are segmented and magnetized in a Block 121 (or even earlier).

    [0100] Furthermore, in a Block 122, a magnetic return is turned. The magnets and the magnetic return are then glued, for example, in a Block 123. A sleeve (cover) is subsequently turned in a Block 124. The magnet system is then glued to the sleeve in a Block 125. This is an example of how a magnet assembly comprising the at least one magnet and a magnetic return can be provided in Step b). In the case of a system without a magnetic return, Blocks 122 and 123 can be omitted.

    [0101] In Block 130, the magnet is disposed and encapsulated in the second longitudinal portion. In other words, it can also be said that, in Block 130, an overall system assembly is provided.

    [0102] For this purpose, the magnetic system (from Block 120) is joined to the impeller or the impeller body (from Block 110) in a Block 131. The magnet or the magnet system is encapsulated with the cover (sleeve). The joints are subsequently welded tight (radially and axially) in a Block 132. The clamping spigot is then removed in a Block 133. The clamping spigot is kept in place until Block 133 for handling reasons.

    [0103] The inner geometry of the impeller body is then turned out in a Block 134. To hollow out the inner geometry by machining, the clamping spigot is first removed (Block 133). The entire system is now held on the welded sleeve. Since the assembly is already assembled, the inner wall thickness (made here of titanium, for example) can also be very thin (wall thickness here approx. 0.1 mm, for example).

    [0104] FIG. 8 schematically shows an illustration of a further here proposed method. The reference signs are used consistently, so that reference can be made in full to the statements regarding the preceding figures (in particular FIGS. 1, 2, 3 and 4).

    [0105] The design variant according to FIG. 8 is an example of how the impeller body 3 can be provided in multiple parts in Step a). In the course of assembly, the magnets 7 can first be joined to the magnet mount 16 (e.g. by gluing). The cover 10 is then pushed on and welded tight. The magnet 7 or the magnet assembly 8 is encapsulated with the cover 10. Finally, the blading 6 is mounted and also welded.

    [0106] When using ceramics, it is particularly advantageous to apply a metallization in advance in order to be able to connect the parts by means of welding or laser brazing. Glued connections are possible as well, since the connection between the blading 6 and the magnet 7 does not have to be tight.

    [0107] The multipart nature of the impeller body 3 can be seen clearly in the exploded view of FIG. 8. The cover 10 can be made from a thin-walled tube or wound from a thin sheet metal and welded longitudinally.

    [0108] FIG. 9 schematically shows a support system 2 implanted in a heart 17. The reference signs are used consistently, so that reference can be made in full to the statements regarding the preceding figures.

    [0109] FIG. 9 shows a ventricular support system 2, i.e. the support system 2, projecting into a (here left) ventricle 18 of the heart 17. The support system 2 is furthermore disposed in aortic valve position, i.e. the support system 2 intersects a cross-section in which the aortic valves 20 are located. The support system 2 supports the heart 17 by conveying or pumping blood from the ventricle 18 into the aorta 19. The blood flow is indicated in FIG. 9 with arrows.

    [0110] The support system 2 comprises an impeller 1 (in the manner of an impeller), which is surrounded by a (here not depicted) impeller housing. In the example of an alignment of the support system 2 shown in FIG. 9, the impeller 1 is located in the aorta 19.