Holding Magnets and Magnet System for Implantable Systems Optimized for MRI
20220072302 · 2022-03-10
Inventors
Cpc classification
A61N1/086
HUMAN NECESSITIES
A61N1/37229
HUMAN NECESSITIES
International classification
A61N1/08
HUMAN NECESSITIES
Abstract
Embodiments of the present invention are directed to an implantable hearing implant, such as cochlear implants. The implantable hearing implant includes an implant device containing signal processing circuitry configured to receive an implant communications signal transmitted from an external transmitting coil. The implantable hearing implant further includes an implant magnet configured to cooperate with a corresponding external holding magnet in an external device located over the overlying skin to magnetically hold the external device against the overlying skin. The implant magnet has a north magnetic pole, a south magnetic pole, and as a whole has an overall magnetic dipole moment that is parallel to or at an angle of 300 or less with respect to the outermost surface. The implant magnet has a north end portion and a south end portion, each having an individual magnetic dipole moment that is inclined with respect to the overall magnetic dipole moment.
Claims
1. An implantable hearing implant comprising: an implant device containing signal processing circuitry configured to receive an implant communications signal transmitted through overlying skin of a patient, wherein the implant device includes an outermost surface adapted to lie between the overlying skin and underlying skull bone and at least approximately parallel to the skin of the patient; and an implant magnet configured to cooperate with an external holding magnet in an external device to be located over the overlying skin to magnetically hold the external device against the overlying skin; wherein the implant magnet has a north magnetic pole, a south magnetic pole, and as a whole has an overall magnetic dipole moment that is parallel to or at an angle of 30° or less with respect to the outermost surface, wherein the implant magnet has a north end portion including the north magnetic pole and a south end portion including the south magnetic pole, the north and south end portions each being formed from permanent magnetic material and each having an individual magnetic dipole moment that is inclined with respect to the overall magnetic dipole moment, and wherein the individual magnetic dipole moment in the north end portion is inclined with respect to the overall magnetic dipole moment such as to have a component pointing towards the outermost surface, and the individual magnetic dipole moment in the south end portion is inclined with respect to the overall magnetic dipole moment such as to have a component pointing away from the outermost surface.
2. The implantable hearing implant of claim 1, wherein the implant magnet is rotatable around a rotation axis that is perpendicular to the outermost surface, or deviates from perpendicular by less than 30°, wherein in each available rotational position of the implant magnet upon rotation around the rotation axis, the overall magnetic dipole moment is parallel to or at an angle of 30° or less with respect to the outermost surface.
3. The implantable hearing implant of claim 2, wherein the implant magnet has a shape that is rotationally symmetric around the rotation axis.
4. The implantable hearing implant of claim 2, wherein the implant magnet has an outer end surface facing the outermost surface of the implant device and an inner end surface facing away from the outermost surface, wherein one or both of the inner and outer end surfaces are perpendicular to the rotation axis.
5. The implantable hearing implant of claim 1, wherein an angle of inclination between each individual magnetic dipole moment in the north and south end portions with respect to the overall magnetic dipole moment is 50°.
6. The implantable hearing implant of claim 1, wherein the implant magnet has an average diameter d.sub.1 in a direction parallel to the overall magnetic dipole moment and an average thickness h.sub.1 in a direction perpendicular to the outermost surface, wherein in one or both of the north and south end portions, the individual magnetic dipole moment is inclined with respect to the overall magnetic dipole moment by an angle α, wherein
arctan(h.sub.I/(d.sub.I/2))−15°≤α≤arctan(h.sub.I/(d.sub.I/2))+7°, or
arctan(h.sub.I/(d.sub.I/2))−10°≤α≤arctan(h.sub.I/(d.sub.I/2))+5°.
7. The implantable hearing implant of claim 1, wherein the north and south end portions are directly adjacent with each other, and each form one of two halves of the implant magnet.
8. The implantable hearing implant of claim 1, wherein the north and south end portions of the implant magnet are separated from each other by an intermediate portion having an individual magnetic dipole moment that is parallel to the overall magnetic dipole moment, or deviates from parallel by less than 10°, or less than 5°.
9. The implantable hearing implant of claim 1, wherein one or both of the north and south end portions of the implant magnet has an outer section closer to the outermost surface and an inner section further away from the outermost surface, wherein an angle of inclination of the individual magnetic dipole moment with respect to the overall magnetic dipole moment in the outer section is less than in the inner section.
10. The implantable hearing implant of claim 1, wherein the implant magnet has an outer end surface facing the outermost surface of the implant device and an inner end surface facing away from the outermost surface, wherein a middle plane is defined to be located at an equal distance from the outer and inner end surfaces, and wherein the implant magnet fulfils one or both of the following criteria (i) and (ii): (i) at least 55%, or at least 65% of the total magnetic flux of a magnetic field generated outside of the implant magnet when placed in isolation in air or a vacuum is located on a side of the middle plane at which the outermost surface is located in the assembled state, (ii) more than 50%, or more than 55% of the mass of the implant magnet is located on a side of the middle plane at which the outermost surface is located, wherein the edges of the implant magnet at the inner end surface are chamfered.
11. The implantable hearing implant of claim 1, wherein the north and south end portions are formed from anisotropic magnet elements each having a preferred magnetization direction, wherein the anisotropic magnet elements are joined with each other or with an intermediate portion arranged in between, wherein the preferred magnetization directions are arranged at an angle with respect to the overall dipole moment of the implant magnet as a whole.
12. The implantable hearing implant of claim 1, wherein on at least part of the inner end surface a layer of magnetic soft material is applied.
13. An implant system comprising: an implantable hearing device according to claim 1; and an external device, the external device comprising signal processing circuitry configured to transmit an implant communications signal to the implantable hearing device, the external device comprising an innermost surface adapted to lie adjacent to the overlying skin; and an external magnet or magnet assembly in the external device to be located over the overlying skin and magnetically configured to cooperate with the implant magnet of the implantable hearing device so as to hold the external device against the overlying skin.
14. The implant system of claim 13, wherein the external magnet has a north magnetic pole, a south magnetic pole, and as a whole has an overall magnetic dipole moment that is parallel to or at an angle of 30° or less with respect to the innermost surface of the external device.
15. The implant system of claim 14, wherein the external magnet has a north end portion including the north magnetic pole and a south end portion including the south magnetic pole, the north and south end portions each being formed from permanent magnetic material and each having an individual magnetic dipole moment that is inclined with respect to the overall magnetic dipole moment of the external magnet, and wherein the individual magnetic dipole moment in the north end portion has a component pointing towards the innermost surface of the external device, and the individual magnetic dipole moment in the south end portion has a component pointing away from the innermost surface of the external device.
16. The implant system of claim 15, wherein the external magnet has an average diameter d.sub.E in a direction parallel to the overall magnetic dipole moment and an average thickness h.sub.E in a direction perpendicular to the innermost surface of the external device, wherein in one or both of the north and south end portions, the individual magnetic dipole moment is inclined with respect to the overall magnetic dipole moment by an angle α, wherein
arctan(h.sub.E/(d.sub.E/2))−15°≤α≤arctan(h.sub.E/(d.sub.E/2))+7°, or
arctan(h.sub.E/(d.sub.I/2))−10°≤α≤arctan(h.sub.E/(d.sub.E/2))+5°.
17. The implant system of claim 15, wherein the north and south end portions of the external magnet are separated from each other by an intermediate portion having an individual magnetic dipole moment that is parallel to the overall magnetic dipole moment of the external magnet or deviates from parallel by less than 10°, or less than 5°.
18. The implant system of claim 15, wherein one or both of the north and south end portions of the implant magnet have an inner section closer to the innermost surface of the external device and an outer section further away from the innermost surface of the external device, wherein an angle of inclination of the individual magnetic dipole moment with respect to the overall magnetic dipole moment in the inner section is less than in the outer section.
19. The implant system of claim 15, wherein the external magnet has an inner end surface facing the innermost surface of the external device and an outer end surface facing away from the innermost surface (958) of the external device, and wherein a middle plane is defined to be located at equal distance from the outer and inner end surfaces of the external device, and wherein the external magnet fulfils one or both of the following criteria (i) and (ii): (i) at least 55%, or at least 65% of the total magnetic flux of a magnetic field generated outside of the external magnet when placed in isolation in air or a vacuum is located on a side of the middle plane at which the innermost surface of the external device is located in the assembled state, (ii) more than 50%, or more than 55% of the mass of the external magnet is located on a side of the middle plane at which the innermost surface is located, wherein the edges of the external magnet at the inner end surface are chamfered.
20. The implant system of claim 15, wherein the north and south end portions of the external magnet are formed from anisotropic magnet elements each having a preferred magnetization direction, wherein the anisotropic magnet elements are joined with each other or with an intermediate portion arranged in between, wherein the preferred magnetization directions are arranged at an angle with respect to the overall dipole moment of the external magnet as a whole.
21. The implant system of claim 13, wherein the external magnet is rotatable around a rotation axis that is perpendicular to the innermost surface of the external device or deviates from perpendicular by less than 30°, wherein in each available rotational position of the external magnet upon rotation around the rotation axis, the overall magnetic dipole moment is parallel to or at an angle of 30° or less with respect to the innermost surface, wherein the external magnet has a shape that is rotationally symmetric around its rotation axis.
22. The implant system of claim 13, wherein the north and south end portions of the external magnet are directly adjacent with each other, and each form one of two halves of the external magnet.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS
[0057] A larger distance between the two magnetic poles has the advantage that the attractive magnetic force for an external magnet does not decrease so steeply with increasing distance between the magnets. Embodiments of the present invention are directed to an improved implant magnet arrangement that uses two cylindrical implant magnets with magnetization direction having a V-shaped magnetic angle. These magnets are mounted in the implant device such that a “strong” side (i.e. the side with high magnetic flux) faces at least partly towards the overlying skin. Both magnets are mounted inside a magnet case in which they can turn also around the rotation axis of the case.
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[0059] There is a magnet case 306 within the implant device 305 with a case rotation axis 307 that is perpendicular to the outermost surface 308 of the implant device 305. The magnet case 306 is configured to be rotatable about the case rotation axis 307. Typically, the magnet case 306 is surrounded by a receiver coil of the implant device 305. The magnet case 306 may be metallic (e.g. made of titanium), or it may be made of a biocompatible non-metallic material (e.g. PEEK, FEP, PTFE, PSU, etc.) and may be coated (e.g. with Parylene). The magnet case 306 may be adapted to facilitate long-term hermetic encapsulation, and/or it may be adapted to be surgically removable for minimized susceptibility to MRI artefacts.
[0060] An implant magnet arrangement includes one or a plurality of cylindrical magnets 300 located within the magnet case 306 and configured to cooperate with a corresponding external holding magnet in an external device located over the overlying skin to magnetically hold the external device against the overlying skin. Each cylindrical implant magnet 300 has a center cylinder axis 301 that is perpendicular to the case rotation axis 307, and each cylindrical magnet 300 is configured to be rotatable about its center cylinder axis 301.
[0061] Each cylindrical magnet 300 has an outer cylindrical surface 302 with a north magnetic pole and a south magnetic pole. In the most general sense, a “cylindrical surface” is a surface consisting of all the points on all the lines which are parallel to a reference line and which pass through a fixed plane curve in a plane not parallel to the given line. In the present disclosure, the cylinder is a so-called right circular cylinder, in which the “fixed plane curve” is a circle, and the reference line is a line that is perpendicular to circle plane, for example the center cylinder axis 301. A north magnetic direction 303 is defined by a radial vector extending from the center cylinder axis 301 to the north magnetic pole. And a similar south magnetic direction 304 is defined by a radial vector extending from the south magnetic pole to the center cylinder axis 301. The north magnetic pole and the south magnetic pole are arranged with respect to each other so as not to lie on a common diameter through the center cylinder axis 301 such that the north magnetic direction 303 and the south magnetic direction 304 form a “magnetic angle” a that is less than 180 degrees with a vertex at the center cylinder axis 301. For example, the magnetic angle α may specifically be between 900 and 1400 (or some other defined range). Such magnetic angle α can be established for example by forming the cylindrical magnet 300 from two preformed portions 309 and 310 which are magnetized according to the above-mentioned north and south magnetic directions 303, 304 in a manner that will be explained with reference to a further embodiment in more detail below. In the embodiment shown in
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[0066] In the embodiments described above, the cylindrical magnets 300 are configured to be fully rotatable about the center cylinder axis 301 through a complete rotation range of 360 degrees, and so that the magnet case 306 containing the cylindrical magnets 300 can turn around its case axis 307. Otherwise, when the center cylinder axis 301 were fixed and a strong external magnetic field 501 is oriented anti-parallel to the cylindrical magnets 300, the magnets would flip by 180° and the magnetically-strong side of the magnets would then face towards the underlying skull in a medial direction instead of towards the skin in lateral direction. Note that the orientation of the external magnetic field 501 in a given MRI scanner is different when an implant user is scanned with the head first versus with legs first. Accordingly, it is advantageous if the magnet arrangement can handle both of these orientations of the external magnetic field 501. Moreover, there is no general convention of the orientation of the external magnetic field 501 in MRI scanners, and in some cases where two MRI scanners are arranged next to each other in the same facility, the orientations of the respective external magnetic fields 501 are even deliberately chosen to be of opposite orientation.
[0067] Still, a further design variant with two cylindrical magnets in V-shaped magnetization also works when the magnets have only one degree of freedom and have a rotation angle limited to about 900 only.
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[0070] In the embodiments described above, despite some individual parts of the implant magnet being oriented perpendicular to the skin surface, the magnets do not weaken in an MRI environment because they immediately turn into a safe orientation relative to the strong static magnetic field of the MRI scanner. Each individual magnet always has a component parallel to the strong static magnetic field of the MRI scanner. And so each individual magnet always aligns such that there is no torque to the outside. The magnetic flux is directed to the skin side and reduced in medial direction. Therefore, the MRI artefact reaches less into the medial direction and is more oriented towards the skin side.
[0071] Shown in
[0072] The implant device 905 includes an outermost surface 908 adapted to lie between the overlying skin 401 and underlying skull bone and is at least approximately parallel to the skin 401 of the implanted patient. The implant device 905 further comprises an implant magnet 900 configured to cooperate with an external holding magnet in an external device 402 to be located over the overlying skin 401 to magnetically hold the external device against the overlying skin 401.
[0073] As indicated in
[0074] The implant magnet 900 is rotatable around a rotation axis 907 that in the embodiment shown is perpendicular to said outermost surface 908 so that in each available rotational position of said implant magnet 900 upon rotation around its rotation axis 907, the overall magnetic dipole moment m is parallel to said outermost surface 908.
[0075] As is seen in
[0076] Moreover, the implant magnet 900 has a north end portion 914 including said north magnetic pole and a south end portion 915 including said south magnetic pole. Both of said north and south end portions 914, 915 are formed from permanent magnetic material and each have an individual magnetic dipole moment 916, 917 that is inclined with respect to said overall magnetic dipole moment m, as will be explained in more detail with reference to
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[0078] More precisely, it is seen that the magnetic dipole moment 916 in said north end portion 914 is inclined in a plane perpendicular to the outermost surface 908/skin 401, to have a component pointing towards said outermost surface 908, and said individual magnetic dipole moment in said south end portion 915 is inclined to have a component pointing away from said outermost surface. This leads to a situation where the bigger part of the magnetic flux B generated by said implant magnet 901 is located to the outside, where it is needed for generating a holding force holding the external magnet 950.
[0079] In particular, in preferred embodiments, when simply regarding the internal magnet 900 in isolation, i.e. without presence of the external magnet 950 and when placed in air or vacuum, at least 55%, preferably at least 65% or even 70% or more of the total magnetic flux B of a magnetic field generated outside of the implant magnet 900 is located “outside” of a middle plane arranged at equal distances from the outer and inner end surfaces 912, 913. Herein, “outside of the middle plane” means the side at which said outermost surface 908 is located in the assembled state. This way, the holding force can be significantly increased over and implant magnet of the same size and material which would be homogeneously magnetized parallel to the skin 401.
[0080] In the embodiment of
[0081] Note that the external magnet 950 in the external device 955 of the embodiment of
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[0086] In the embodiment shown, both the implant magnet 900 and the external magnet 950 are manufactured from two separate anisotropic magnet pieces which form the north and south end portions 914, 915; 964, 965 in the finished magnet 900, 950. The anisotropic magnet pieces each have a preferred magnetization direction that corresponds to the direction of the individual magnetic dipole moment 916, 917; 966, 967 in the finished magnet 900, 950. The preferred magnetization direction can be imprinted on the magnet material by applying a corresponding magnetic field upon its manufacture, for example during a corresponding sintering process. The respective magnet pieces can be joined for example by gluing them together, and only after joining them, the final magnetization is established by applying a strong magnetization pulse parallel to the direction of the overall dipole moment of the finished magnet 900, 950. Due to the anisotropic character of the magnet pieces, this magnetization pulse will not magnetize both pieces along the direction of the magnetic field of the strong magnetization pulse, but will magnetize them according to their preferred magnetization directions. In preferred embodiments, the implant magnet 900 and/or the external magnet 950 is a rare earth magnet, in particular a rare earth magnet comprising neodymium, samarium, terbium, dysprosium or holmium.
[0087] In the embodiments of both,
[0088] In alternative embodiments, however, north and south end portions of said implant magnet may be separated from each other by an intermediate portion having an individual magnetic dipole moment that is (at least approximately) parallel to said overall magnetic dipole moment. An example for this is shown with respect to the external magnet 950 in
[0089] In addition or alternatively, one or both of said north and south end portions 914, 915 of said implant magnet 900 may have an outer section 914a, 915a closer to the outermost surface 908 (not shown in
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[0091] The upper part of
|τ|=m.sub.o.Math.|B|−sin(α+ε)−m.sub.o.Math.|B|.Math.sin(α−ε)=2.Math.m.sub.o.Math.|B|.Math.sin(ε).Math.cos(α).
[0092] Comparing this torque to the torque experienced by a conventional homogeneously magnetized implant magnet of same dimensions, one can assume that 2.Math.m.sub.o≈|m|, with |m| being again the magnitude of the magnetic dipole moment of the conventional homogeneously magnetized implant magnet. It is therefore seen that the torque experienced by the implant magnet 900 according to an embodiment of the invention in the inclined external magnetic field B is actually reduced by a factor of cos(α) as compared to the conventional magnet of the same size, making the implant magnet 900 according to an embodiment of the invention less sensitive to deviations from the idealized assumption of an external magnetic field being parallel to the skin.
[0093] Although various exemplary embodiments of the invention have been disclosed, it should be apparent to those skilled in the art that various changes and modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention.