COCHLEAR IMPLANTS HAVING MRI-COMPATIBLE MAGNET APPARATUS AND ASSOCIATED SYSTEMS AND METHODS
20230115968 · 2023-04-13
Inventors
Cpc classification
International classification
Abstract
A system including a cochlear implant with a cochlear lead including a plurality of electrodes, an antenna, a stimulation processor operably connected to the antenna and to the cochlear lead, and a magnet apparatus, adjacent to the antenna, including a case defining a central axis, a frame within the case and rotatable relative to the case about the central axis of the case, and only two elongate diametrically magnetized magnets that are located in the frame, that are separated from one another by a fixed non-zero distance, that each define a longitudinal axis and a N-S direction, and that are rotatable about the longitudinal axis relative to the frame, and an external device including an axially magnetized disk-shaped positioning magnet and an antenna adjacent to the axially magnetized disk-shaped positioning magnet.
Claims
1. A method, comprising: positioning a head wearable external component, including an axially magnetized magnet that defines a N-S direction and an antenna, on a portion of a user's head over an implanted cochlear implant including a magnet apparatus; wherein the magnet apparatus includes a case that defines a central axis, a frame within the case and rotatable about the central axis of the case, and only two elongate diametrically magnetized magnets that are located in the frame, that each define a longitudinal axis and a N-S direction, that are rotatable about the longitudinal axis relative to the frame, and that are separated from one another by a fixed non-zero distance D1 that is perpendicular to at least one of the longitudinal axes; wherein the elongate diametrically magnetized magnets are formed from magnetic material and define a configuration, and the axially magnetized magnet is formed from magnetic material and defines a configuration; wherein the material and configuration of the elongate diametrically magnetized magnets are such that the elongate diametrically magnetized magnets are attracted to one another with an attraction force F1 and, absent a dominant magnetic force, will align with one another in the N-S direction; wherein there is a distance D2 between the axially magnetized magnet of the positioned head wearable external component and the elongate diametrically magnetized magnets; and wherein the materials and configurations of the axially magnetized magnet and the elongate diametrically magnetized magnets are such that, when the distance D2 is 12 mm, there is a magnetic attraction force F2, which is greater than the magnetic attraction force F1, between axially magnetized magnet of the positioned head wearable external component and the elongate diametrically magnetized magnets of the implanted cochlear implant.
2. A method as claimed in claim 1, wherein the magnetic attraction force F2 is at least about 10% greater than the magnetic attraction force F1 when the distance D2 is 12 mm.
3. A method as claimed in claim 1, wherein the axially magnetized magnet comprises an N55 magnet having a diameter of about 11.45 mm and a length of about 7.6 mm; and the elongate diametrically magnetized magnets comprise N52 magnets each having a diameter of about 2.3 mm and a length of about 8.3 mm.
4. A method as claimed in claim 3, wherein the fixed non-zero distance D1 is about 3.8 mm to about 4.2 mm.
5. A method as claimed in claim 4, wherein the frame includes two receptacles; one of the elongate diametrically magnetized magnets is located in each of the receptacles; and the receptacles are separated by the non-zero distance D1.
6. A method as claimed in claim 1, wherein the axially magnetized magnet generates a magnetic field; portions of the magnetic field pass through the elongate diametrically magnetized magnets; and the materials and configurations of the axially magnetized magnet and the elongate diametrically magnetized magnets are such that, when the distance D2 is 12 mm, the respective N-S directions of the elongate diametrically magnetized magnets will align with the portions of the magnetic field that pass through the elongate diametrically magnetized magnets.
7. A method as claimed in claim 1, wherein the N-S direction of the axially magnetized magnet is at least substantially perpendicular to the portion of a user's head.
8. A method as claimed in claim 1, wherein the case defines an internal volume; and the elongate diametrically magnetized magnets define a total magnet volume that is less than about 20% to about 30% of the internal volume of the case.
9. A system, comprising: a cochlear implant having a cochlear lead including a plurality of electrodes, an implant antenna, an implant processor operably connected to the implant antenna and to the cochlear lead, and an implant magnet assembly, adjacent to the implant antenna, including an implant magnet case defining a central axis, a frame within the implant magnet case and rotatable relative to the implant magnet case about the central axis of the implant magnet case, and only two elongate diametrically magnetized implant magnets that are located in the frame, that each define a longitudinal axis and have an individual magnetic dipole moment, that are rotatable about the longitudinal axis relative to the frame, and that are separated from one another by a fixed non-zero distance D1 that is perpendicular to at least one of the longitudinal axes; and a head wearable external component including an axially magnetized external magnet and an external antenna adjacent to the axially magnetized external magnet.
10. A system as claimed in claim 9, wherein the individual magnetic dipole moments of the elongate diametrically magnetized implant magnets are oriented substantially in the direction of the axially magnetized external magnet during attractive transcutaneous magnetic interaction with the axially magnetized external magnet.
11. A system as claimed in claim 9, wherein the elongate diametrically magnetized implant magnets are formed from magnetic material and define a configuration, and the axially magnetized external magnet is formed from magnetic material and defines a configuration; the materials and configurations of the elongate diametrically magnetized implant magnets are such that they are attracted to one another with an attraction force F1 and, absent a dominant magnetic force, the magnetic dipole moments will align with one another; and the material and configuration of the axially magnetized external magnet and the elongate diametrically magnetized implant magnets are such that, when there is a distance D2 of 12 mm between the axially magnetized external magnet and the elongate diametrically magnetized implant magnets, there is a magnetic attraction force F2, which greater than the magnetic attraction force F1, between axially magnetized external magnet of the positioned head wearable external component and the elongate diametrically magnetized implant magnets.
12. A system as claimed in claim 11, wherein the magnetic attraction force F2 is at least about 10% greater than the magnetic attraction force F1 when the distance D2 is 12 mm.
13. A system as claimed in claim 9, wherein the implant magnet case defines an internal volume; and the elongate diametrically magnetized implant magnets define a total magnet volume that is less than about 20% to about 30% of the internal volume of the implant magnet case.
14. A system as claimed in claim 9, wherein the fixed non-zero distance D1 is about 3.8 mm to about 4.2 mm.
15. A system as claimed in claim 9, wherein the frame includes two receptacles; one of the elongate diametrically magnetized implant magnets is located in each of the receptacles; and the receptacles are separated by the non-zero distance D1.
16. A system as claimed in claim 9, wherein the axially magnetized external magnet comprises an N55 magnet having a diameter of about 11.45 mm and a length of about 7.6 mm; and the elongate diametrically magnetized implant magnets comprise N52 magnets each having a diameter of about 2.3 mm and a length of about 8.3 mm.
17. A magnet apparatus, comprising: a case defining a central axis; a magnet frame within the case and rotatable about the central axis of the case; and only two elongate diametrically magnetized magnets that are located in the frame, that each define a longitudinal axis and a N-S direction, that are rotatable about the longitudinal axis relative to the frame, that are separated from one another by a fixed non-zero distance that is perpendicular to at least one of the longitudinal axes, and that are attracted to one another with a magnetic attraction force that is less than 3.0 N.
18. A magnet apparatus as claimed in claim 17, wherein the magnetic attraction force is about 0.26 N.
19. A magnet apparatus as claimed in claim 17, wherein the fixed non-zero distance is about 3.8 mm to about 4.2 mm.
20. A magnet apparatus as claimed in claim 17, wherein the case defines an internal volume; and the elongate diametrically magnetized magnets define a total magnet volume that is less than about 20% to about 30% of the internal volume of the case.
21. A magnet apparatus as claimed in claim 17, wherein the frame includes two receptacles; one of the elongate diametrically magnetized magnets is located in each of the receptacles; and the receptacles are separated by the non-zero distance.
22. A magnet apparatus as claimed in claim 17, wherein the axially magnetized magnet comprises an N55 magnet having a diameter of about 11.45 mm and a length of about 7.6 mm; and the elongate diametrically magnetized magnets comprise N52 magnets each having a diameter of about 2.3 mm and a length of about 8.3 mm.
23-33. (canceled)
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] Detailed descriptions of the exemplary embodiments will be made with reference to the accompanying drawings.
[0015]
[0016]
[0017]
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
[0030]
[0031]
[0032]
[0033]
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0034] The following is a detailed description of the best presently known modes of carrying out the inventions. This description is not to be taken in a limiting sense, but is made merely for the purpose of illustrating the general principles of the inventions.
[0035] As illustrated for example in
[0036] The case 102 in the exemplary magnet apparatus 100 is disk-shaped and defines a central axis A1, which is also the central axis of the frame 108. The frame 108 is rotatable relative to the case 102 about the central axis A1 over 360°. The magnets 110 rotate with the frame 108 about the central axis A1. Each magnet 110 is also rotatable relative to the frame 108 about its own longitudinal axis A2 (also referred to as “axis A2”) over 360°. In the exemplary implementation illustrated in
[0037] The exemplary case 102 is not limited to any particular configuration, size or shape. In the illustrated implementation, the case 102 is a two-part structure that includes the base 104 and the cover 106 which are secured to one another in such a manner that a hermetic seal is formed between the cover and the base. Suitable techniques for securing the cover 106 to the base 104 include, for example, seam welding with a laser welder. With respect to materials, the case 102 may be formed from biocompatible paramagnetic metals, such as titanium or titanium alloys, and/or biocompatible non-magnetic plastics such as polyether ether ketone (PEEK), low-density polyethylene (LDPE), high-density polyethylene (HDPE), ultra-high-molecular-weight polyethylene (UHMWPE), polytetrafluoroethylene (PTFE) and polyamide. In particular, exemplary metals include commercially pure titanium (e.g., Grade 2) and the titanium alloy Ti-6AI-4V (Grade 5), while exemplary metal thicknesses may range from 0.20 mm to 0.25 mm. With respect to size and shape, the case 102 may have an overall size and shape similar to that of conventional cochlear implant magnets so that the magnet apparatus 100 can be substituted for a conventional magnet in an otherwise conventional cochlear implant. The case 102 may also have an overall size and shape that is larger than that of conventional cochlear implant magnets in other embodiments. In some implementations, the diameter that may range from 9 mm to 17.4 mm and the thickness may range from 1.5 mm to 4.0 mm. The diameter of the case 102 in the illustrated embodiment is about 12.6 mm and the thickness is about 3.1 mm. As used herein in the context of the case 102, the word “about” means±10%.
[0038] The exemplary frame 108 includes a disk 112 and only two receptacles 114. A used herein, the phrase “only two” means “two and no more than two.” The receptacles 114 extend completely through the disk and that are defined by inner walls 116. Suitable materials for the frame 108, which may be formed by machining, metal injection molding or injection molding, include paramagnetic metals, polymers and plastics such as those discussed above in the context of the case 102. Referring more specifically to
[0039] The magnets 110 in the exemplary magnet apparatus 100 are elongate diametrically magnetized magnets, and there are only two magnets 110 within the case 102. As noted above, the phrase “only two” is used herein to mean “two and no more than two.” The exemplary magnets 110 are circular in a cross-section that is perpendicular to the longitudinal axis A2 and, in some instances, may have rounded corners. Suitable materials for the magnets 110 include, but are not limited to, neodymium-boron-iron and samarium-cobalt. The frame 108 maintains the maintains the spacing between the magnets 110. As is discussed in greater detail below, the magnetic attraction force F1 between the two spaced magnets 110, which is a function of the distance between the magnets, is such that the magnets will remain substantially aligned with one another in the N-S direction, as shown in
[0040] The magnets 110 may be located within tubes 118 formed from low friction material. Suitable materials for the tubes 118 include polymers, such as silicone, PEEK and other plastics, PTFE, and PEEK-PTFE blends, and paramagnet metals. The magnets 110 may be secured to the tubes 118 such that the each tube rotates with the associated magnet about its axis A2, or the magnets may be free to rotate relative to the tubes. The magnet/tube combination is also more mechanically robust than a magnet alone. The magnets 110 may, in place of the tubes 118, be coated with the lubricious materials discussed below.
[0041] Friction may be further reduced by coating the inner surfaces of the case 102 and/or the surfaces of the frame 108 with a lubricious layer. The lubricious layer may be in the form of a specific finish of the surface that reduces friction, as compared to an unfinished surface, or may be a coating of a lubricious material such as diamond-like carbon (DLC), titanium nitride (TiN), PTFE, polyethylene glycol (PEG), Parylene, fluorinated ethylene propylene (FEP) and electroless nickel sold under the tradenames Nedox® and Nedox PF™. The DLC coating, for example, may be only 0.5 to 5 microns thick. In those instances where the base 104 and a cover 106 are formed by stamping, the finishing process may occur prior to stamping. Micro-balls, biocompatible oils and lubricating powders may also be added to the interior of the case to reduce friction. In the illustrated implementation, the surfaces of the frame 108 may be coated with a lubricious layer 120 (e.g., DLC), while the inner surfaces of the case 102 do not include a lubricious layer, as shown in
[0042] Referring to
[0043] Another aspect of the exemplary magnet apparatus 100 is the impact resistance associated with the locations of the elongate diametrically magnetized magnets 110. When the magnet apparatus 100 is subjected to an impact force (e.g., when the user bumps his/her head), the central portion of the case 102 will deflect inwardly. Advantageously, the magnets 110 are offset from the central axis A1 of the case 102 by the distance D1 (
[0044] Referring also to
[0045] It should be noted here that although the diametrically magnetized magnets 110 are identical to one another, are parallel to one another, and are equidistant from the central axis A1 of the case 102 in the illustrated embodiment, the present magnet apparatus are no so limited. By way of example, but not limitation, the diametrically magnetized magnets 110 may have different lengths and/or may have different diameters and/or may be formed from materials having the same or different strength. Alternatively, or in addition, the diametrically magnetized magnets 110 may be non-parallel, and be different distances from the central axis A1 of the case 102. The configurations of the receptacles 114 would be adjusted to accommodate that of the magnets 110.
[0046] Turning to
[0047] Another exemplary magnet apparatus is generally represented by reference numeral 100a in
[0048] Suitable materials for the frame 108a include those discussed above with reference to the case 102 and frame 108. By way of example, but not limitation, the frame 108a may be formed from a DLC coated metal material. In the illustrated implementation, the frame 108a is formed from molded PEEK and an open region 130 defined between the upper and lower curved flanges 126 and 128. The lack of molded material in the open region 130 prevents distortion of the molded frame 108a as the frame cools during the manufacturing process. Material may be removed from other portions of a molded frame for the same reason. To that end, the exemplary fame 108b illustrated in
[0049] The PEEK (or other molded material) may be protected from the heat associated with the welding of the case cover 106 to the base 104 through the use of a titanium ring 132 that is positioned against the inner surface of the case 102. The titanium ring 132 may be omitted when a metal frame 108a is employed.
[0050] One example of a cochlear implant (or “implantable cochlear stimulator”) including the present magnet apparatus 100 (or 100a) is the cochlear implant 200 illustrated in
[0051] Turning to
[0052] The exemplary body worn sound processor 300 in the exemplary ICS system 60 includes a housing 302 in which and/or on which various components are supported. Such components may include, but are not limited to, sound processor circuitry 304, a headpiece port 306, an auxiliary device port 308 for an auxiliary device such as a mobile phone or a music player, a control panel 310, one or more microphones 312, and a power supply receptacle 314 for a removable battery or other removable power supply 316 (e.g., rechargeable and disposable batteries or other electrochemical cells). The sound processor circuitry 304 converts electrical signals from the microphone 312 into stimulation data. The exemplary headpiece 400 includes a housing 402 and various components, e.g., a RF connector 404, a microphone 406, an antenna (or other transmitter) 408 and an axially magnetized disk-shaped positioning magnet 410, that are carried by the housing. The headpiece 400 may be connected to the sound processor headpiece port 306 by a cable 412. The external positioning magnet 410 is attracted to the magnet apparatus 100 of the cochlear stimulator 200 (see
[0053] In at least some implementations, the cable 412 will be configured for forward telemetry and power signals at 49 MHz and back telemetry signals at 10.7 MHz. It should be noted that, in other implementations, communication between a sound processor and a headpiece and/or auxiliary device may be accomplished through wireless communication techniques. Additionally, given the presence of the microphone(s) 312 on the sound processor 300, the microphone 406 may be also be omitted in some instances.
[0054] The functionality of the sound processor 300 and headpiece 400 may also be combined into a single head wearable sound processor that includes all of the external components (e.g., the battery, microphone, sound processor, antenna coil and magnet). Examples of head wearable sound processors are illustrated and described in U.S. Pat. Nos. 8,811,643 and 8,983,102, which are incorporated herein by reference in their entirety. Headpieces and head wearable sound processors are collectively referred to herein as “head wearable external components.”
[0055] The present inventions are applicable to systems that include cochlear implants which have already been implanted into the recipient. For example, a similarly sized magnet, or a magnet apparatus with a similarly sized case, may be removed in situ from an implanted cochlear implant (Step 01). In some instances, the magnet or magnet apparatus may be removed from a pocket in the cochlear implant housing. The exemplary magnet apparatus 100 (or 100a) described herein may be installed in place of the removed magnet or magnet apparatus (Step 02). In some instances, the magnet apparatus 100 (or 100a) may be inserted into the same pocket in the cochlear implant housing from which magnet or magnet apparatus was removed. Suitable removal and installation tools and techniques are illustrated and described in U.S. Pat. No. 10,124,167, which is incorporated herein by reference in its entirety. The headpiece magnet in the associated system may, if necessary, be removed from the headpiece or other head wearable external component and replaced with an axially magnetized magnet.
[0056] Although the inventions disclosed herein have been described in terms of the preferred embodiments above, numerous modifications and/or additions to the above-described preferred embodiments would be readily apparent to one skilled in the art. The inventions include any combination of the elements from the various species and embodiments disclosed in the specification that are not already described. It is intended that the scope of the present inventions extend to all such modifications and/or additions and that the scope of the present inventions is limited solely by the claims set forth below.