Medical implants and electronics and antenna assemblies for use therewith

Abstract

An electronic device and antenna assembly for use with medical implants are disclosed.

Description

Technical Field

[0001] This disclosure generally relates to percutaneous dynamic medical implants. Background Technology

[0002] Inductive links are commonly used to transmit power and data to implantable medical devices, such as prosthetic devices including cochlear and retinal implants, pacemakers, implantable defibrillators, recording devices, and neuromuscular stimulators. Many implantable devices include, among other things, various electronic components housed within a hermetically sealed electronic housing and an antenna coil located on the side of the housing and operatively connected to the electronic components within the housing. During use, an external antenna coil is positioned above the implantable antenna coil. Power, and in some cases data, is supplied to the implantable device via an inductive link between the antenna coils.

[0003] Some implantable cochlear stimulation (“ICS”) systems include, for example, external sound processors and cochlear implants with electrode arrays. The electrode arrays can be positioned within the cochlea or inserted directly into the cochlear nerve without residing within the cochlea. (Reference) Figure 1 An exemplary cochlear implant 10 includes a processor assembly 12 and an antenna coil (or “antenna”) 14 located within a flexible housing 16 formed of a silicone elastomer or other suitable material, and a cochlear lead 18 extending outward from the flexible housing. The processor assembly 12 includes a printed circuit board (“PCB”) 20 located within a titanium housing 22, operatively connected to the antenna 14 and the cochlear lead 18. The antenna 14 receives data and power via an inductive link to an external antenna of a sound processor headpiece and is spaced apart from the titanium housing 22 to reduce the likelihood of generating inefficient eddy currents in the housing material. Optimal communication is achieved when the implant antenna 14 and the headpiece antenna are aligned with each other. For this purpose, the cochlear implant 10 includes a positioning magnet 24 that is attracted to a corresponding headpiece magnet to maintain the headpiece antenna in a position above the implant antenna. The magnet 24 may be located within a recess 26 in the flexible housing 16 and may be removed by means of a magnet hole 28 if desired. The cochlear inductor 18 may include a flexible body 30, an electrode array 32 located at one end of the flexible body, and multiple wires (not shown) extending through the flexible body from conductive contacts 34 (e.g., platinum contacts) in the array 32 to the other end of the flexible body. A stimulation processor 21 on the PCB 20 converts stimulation data received via the antenna 14 into an electrical stimulation current, which is applied to different combinations of electrodes in the electrode array 32 to create the perception of sound.

[0004] A representative ICS system is disclosed in U.S. Patent No. 5,824,022, entitled "Cochlear Stimulation System Employing Behind-The-Ear Sound Processor With Remote Control," which is incorporated herein by reference in its entirety. Examples of commercial ICS sound processors include, but are not limited to, Advanced Bionics Harmony. TM BTE sound processor, Advanced Bionics Naída CI Q series BTE sound processor and Advanced Bionics Neptune TM The body wears a sound processor.

[0005] The inventors of this invention have determined that conventional cochlear implants are easily modified. For example, the inventors of this invention have determined that it is desirable to reduce the size of cochlear implants. Summary of the Invention

[0006] An electronic device and antenna assembly for a medical implant includes: a metallic electronic device housing having an internal volume, end walls, and an external recess adjacent to the end walls; electronic components located within the internal volume; an antenna located within the external recess; and an electromagnetic shielding element located within the external recess between the antenna and the end walls. The invention also includes implantable medical devices (such as cochlear implants) incorporating such electronic devices and antenna assemblies.

[0007] An electronic device and antenna assembly for a medical implant includes: a metal electronic device housing including a first end wall and a second end wall facing each other and defining an internal volume therebetween; a magnet housing located within the electronic device housing and including a portion of the first end wall, a portion of the second end wall, and a cylindrical wall located between the portions of the first end wall and the second end wall; electronic components located within the internal volume and outside the magnet housing; and at least one rotatable magnet located within the magnet housing.

[0008] A cochlear implant includes an electronic device and an antenna assembly, the electronic device and antenna assembly having an internal magnet shell, an elastomer covering at least a portion of the electronic device and antenna assembly, and a cochlear lead connected to the electronic device and antenna assembly. The electronic device and antenna assembly and the elastomer occupy a first volume, the magnet shell includes an interior defining a second volume, and the ratio of the first volume to the second volume is less than or equal to 9.7.

[0009] The above and many other features of the invention will become apparent as the invention is better understood by referring to the following detailed description taken in conjunction with the accompanying drawings. Attached Figure Description

[0010] Exemplary embodiments will be described in detail with reference to the accompanying drawings.

[0011] Figure 1 This is a top view of a standard implantable cochlear stimulator.

[0012] Figure 2 This is a top view of an exemplary implantable cochlear stimulator according to an embodiment of the present invention.

[0013] Figure 3 yes Figure 2 A perspective view of a portion of an implantable cochlear stimulator.

[0014] Figure 4 yes Figure 2 A top view of a portion of an implantable cochlear stimulator.

[0015] Figure 5 is an exploded perspective view of an electronic device and antenna assembly according to an embodiment of the present invention.

[0016] Figure 6 is a perspective view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0017] Figure 7 is a top view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0018] Figure 8 is a bottom cross-sectional view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0019] Figure 9 is a side view of the electronic devices and antenna assembly shown in Figure 5.

[0020] Figure 10 This is a top view of a portion of the electronic devices and antenna assembly shown in Figure 5.

[0021] Figure 11 This is an exploded perspective view of a portion of the electronic devices and antenna assembly shown in Figure 5.

[0022] Figure 12 This is a bottom view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0023] Figure 13 This is an exploded perspective view of a portion of the electronic devices and antenna assembly shown in Figure 5.

[0024] Figure 14 is an exploded perspective view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0025] Figure 15 is a top view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0026] Figure 16 is a cross-sectional view taken along line 16-16 in Figure 5.

[0027] Figure 17 is an exploded perspective view of a portion of the electronic device and antenna assembly shown in Figure 5.

[0028] Figure 18 is a cross-sectional view taken along line 18-18 in Figure 17.

[0029] Figure 19 This is a top view of an exemplary implantable cochlear stimulator according to an embodiment of the present invention.

[0030] Figure 20 yes Figure 19 A perspective view of a portion of an implantable cochlear stimulator.

[0031] Figure 21 This is a perspective view of an electronic device and antenna assembly according to an embodiment of the present invention.

[0032] Figure 22 yes Figure 21 Partial exploded perspective view of the electronic components and antenna assembly shown.

[0033] Figure 23 This is a schematic diagram of an exemplary ICS system. Detailed Implementation

[0034] The following is a detailed description of the currently known best mode for carrying out the invention. This description should not be construed as limiting, but is made merely to illustrate the general principles of the invention.

[0035] This invention can be applied to a variety of systems, including but not limited to systems that provide sound (i.e., sound or the perception of sound) to hearing-impaired individuals. An example of such a system is an ICS system, in which an external sound processor communicates with a cochlear implant; therefore, the invention can be discussed in the context of cochlear implants. However, the invention is not limited thereto, and can be applied to other systems, for example, that transmit power and data to implantable medical devices via inductive links.

[0036] An example of a cochlear implant (or "implantable cochlear stimulator") is Figure 2-4 The cochlear implant 100 is shown. The cochlear implant 100 includes: an electronics and antenna assembly (“EA assembly”) 102 with an electronics housing 104 and an antenna 106 mounted to the top of the electronics housing; and a cochlear lead wire 108. The exemplary electronics housing 104 (and the electronics housing 104 discussed below) can be formed of a metal, such as a titanium alloy (e.g., Ti-6Al-4V Grade 5), commercially available pure titanium (Grade 2), or some other biocompatible metal of suitable strength. It includes a stimulation processor 196 (… Figure 11 The printed circuit board (“PCB”) 110 for the device and various other electronic components may be located within the electronic device housing 104 and operatively connected to the antenna 106 and the cochlear implant 108. As discussed in more detail below, the magnetic resonance imaging (“MRI”) compatible magnet assembly 112 ( Figure 4 The device may have one or more rotatable magnets located within the electronic housing 104, and in at least some cases, portions of the electronic housing 104 may form part or all of the housing within the electronic housing for the magnet assembly 112. An exemplary cochlear implant 108 has a flexible body 114, an electrode array 116 at one end of the flexible body, and multiple wires (not shown) extending through the flexible body from conductive contacts 118 (e.g., platinum contacts) in the array 116 to the other end of the flexible body. The wires are operatively connected to the PCB 110 in a manner described below with reference to FIG8. The top, bottom, and sides of the EA assembly 102 may be covered with an overmolded member 120 (e.g., silicone elastomer or other suitable material), which includes a housing cover portion 122 and a strain relief portion 124. A portion of the electronic housing 104 is exposed through an opening 126 in the overmolded member to define a ground contact 128. A ground connection (not shown) is formed between the electronic housing 104 and the PCB 110.

[0037] Referring to Figures 5-8, the exemplary EA assembly 102 also includes an electromagnetic shield 130 located between the electronics housing 104 and the antenna 106, and an antenna / shielding cover 132 above the antenna and the electromagnetic shield. During inductive communication between the antenna 106 and an external antenna, the electromagnetic shield 130 eliminates (or at least significantly reduces) inefficiency-degrading eddy currents in the metallic electronics housing 104, while the antenna / shielding cover 132 protects the antenna 106 and the electromagnetic shield 130. The antenna / shielding cover 132 also seals the antenna 106 and the electromagnetic shield 130 between the cover 132 and the exterior of the electronics housing 104.

[0038] There are many advantages associated with the above arrangement. By way of example and not limitation, placing the antenna 106 outside the electronic device housing 104 would result in an implantable medical device (e.g., Figure 2 The cochlear implant shown is a device whose antenna is offset from the electronic housing (e.g., Figure 1 The cochlear implant shown is more compact. The inventors of this invention have determined that one way to quantify the compactness of an implantable medical device with a magnet assembly (or magnet) is the relationship between the volume occupied by the entire EA assembly and associated overmolded portion (including the volume within the EA assembly occupied by the magnet assembly) and the volume occupied by the rotatable magnet assembly (or rotatable magnet). Reference Figure 3 and Figure 4 The exemplary EA component 102 and the overmolded part 122, together having a length L of 31.7 mm, a varying width W of 25.5 mm at its widest point, and a thickness T of 3.9 mm, together occupy a volume of 2.6 cm. 3 Variations in length L, width W, and thickness T may result in a difference of + / - 0.6 cm. 3 The volume change. The volume occupied by magnet assembly 112 (the internal volume of the magnet housing described below) is 0.33 cm³. 3 In the illustrated embodiment, the ratio of the total volume of the EA assembly and associated overmolded part to the volume of the magnet assembly is less than or equal to 9.7. The ratio in the illustrated embodiment is 7.9. Although this ratio may be lower in other embodiments, the lower limit of the current ratio range is 6.1.

[0039] The exemplary electronic device housing 104 includes a housing base 134 and a housing cover 136, which can be secured to each other to enclose the PCB 110 and the MRI-compatible magnet assembly 112, as referenced below. Figure 10-1 As discussed in Figure 8. Specifically, the housing base 134 and housing cover 136 can be secured to each other in a manner that forms an hermetically tight seal between the cover and the base. Suitable techniques include, for example, seam welding using a laser welder. The housing cover 136 is configured to receive the electromagnetic shield 130, the antenna 106, and the antenna / shielding cover 132. Specifically, the housing cover 136 includes an end wall 138 and a side wall 140 that together define a notch (or “groove” or “external volume”) 142 (FIG. 5), the notch being sized and shaped to receive the electromagnetic shield 130, the antenna 106, and the antenna / shielding cover 132. The magnet device housing (discussed below with reference to FIG. 16-18) is part of the electronics housing 104, and a portion of the magnet device housing (i.e., the portion defined by the cylindrical member 186 and the disk 188) extends upward from the end wall 138. The upper surface of the disk 188 defines a ground contact 128.

[0040] In the illustrated embodiment, antenna 106 (FIGs 5-8) includes a conductive antenna coil 144 on a thin, non-conductive substrate 146. The antenna coil 144 may be formed, for example, printed or otherwise, on the surface of substrate 146. Suitable conductive materials for the antenna coil 144 include gold and platinum, while suitable non-conductive materials for substrate 146 include liquid crystal polymers (“LCP”) and hermetically sealed polyimide. Substrate 146 is also annular to accommodate a cylindrical member 186. A non-conductive material layer (not shown) may also be formed above the associated surfaces of antenna coil 144 and substrate 146. Exemplary antennas including antenna coils formed on a substrate and suitable for medical implants are disclosed in U.S. Patent Publication No. 2015 / 0025613.

[0041] The exemplary antenna 106 is also provided with a pair of connector tabs 148, each connector tab including a non-conductive tab substrate 150 and a tab conductor 152 connected to a corresponding end of the antenna coil 144. The tab substrate 150 (which may be integral with the annular substrate 146) extends outward from the annular substrate, through corresponding sets of openings 154 and 156 in the electronics housing 104, and into the interior of the electronics housing. The tab conductor 152 and correspondingly the antenna coil 144 are connected to the PCB 110 by means of a feedthrough 158. The exemplary feedthrough 158 includes a ceramic insulator block 160 and a plurality of feedthrough pins 162 extending through the insulator block. The exemplary feedthrough is disclosed in U.S. Patent Publication No. 2014 / 0262493. Each tab conductor 152 is connected to one end of a corresponding feedthrough pin 162, and the PCB 110 is connected to the other end. Other feedthrough pins 162 are connected to lead wires (not shown) of the cochlear wire 108. An opening 164 is provided to allow lead wires to enter the electronic device housing 104. Two feedthroughs 158 are employed in the illustrated embodiment (note...). Figure 11 During assembly, access to the feedthrough is obtained via an opening 190 in the end wall 178 of the electronic device housing (discussed below). After the antenna and lead wires are connected, the opening 190 is closed with a cover 192, and the openings 154, 156, and 164, as well as the cover 192, are covered by an overmolded member 120. Figure 2-4 ).

[0042] An exemplary electromagnetic shield 130 (which may be formed of a high-permeability material, such as soft ferrite like nickel-zinc ferrite) includes a plate 166 configured (i.e., sized and shaped) to fit into a recess 142 on an electronics housing cover 136. In some embodiments, the thickness of the soft ferrite sheet can range from about 0.1 mm to about 1.5 mm. As used herein, “about” means + / - 10% and all values ​​in between. The permeability (μ) of the “high-permeability material” ranges from about 25 to about 250. An opening 168 extends through the plate 166 to receive a cylindrical member 186. The electromagnetic shield 130 also includes an annular recess 170 for an antenna coil 144 for the antenna 106 and for the substrate 146. An opening 172 provided for the antenna tab 148 is aligned with openings 154 and 156. The high-permeability electromagnetic shield 130 provides a conduction path for magnetic flux, which guides the magnetic flux away from the metal electronic device housing 104, thereby reducing eddy currents and associated efficiency losses.

[0043] In an exemplary embodiment, the antenna / shielding cover 132 includes a plate 174, which is also configured to fit into a recess 142 on the electronics housing cover 136 and above the antenna 106 and the electromagnetic shielding 130. An opening 176 extends through the plate 174 to receive a cylindrical member 186. The antenna / shielding cover 132 (which protects the antenna 106 and the electromagnetic shielding 130 from impact and seals the non-biocompatible electromagnetic shielding within the EA assembly 102) may be formed of polyetheretherketone (“PEEK”) or other suitable non-conductive, high-strength materials. In some cases, a sealing material such as a biocompatible epoxy resin may be used in conjunction with the antenna / shielding cover 132 to hermetically seal the electromagnetic shielding 130 within the recess 142. Alternatively or additionally, the non-biocompatible electromagnetic shield 130 can be further isolated from the body by coating the electromagnetic shield with a biocompatible polymer such as PEEK, polyphenylsulfone (“PPSU”) or polytetrafluoroethylene (“PTFE”).

[0044] Turning to Figure 9, in the illustrated embodiment, a portion of the defined ground contact 128 of the electronic device housing protrudes beyond the end of the housing cover sidewall 140 (and the top surface of the antenna / shielding cover 132) by a distance D. This distance D can be equal to the thickness of the overmolded housing cover portion 122. As a result, the exposed ground contact 128 is flush with the outer surface of the adjacent portion of the overmolded portion 120.

[0045] The antenna 106 is positioned within the annular groove 170 of the electromagnetic shield 130 to protect it from impacts, as is the antenna / shielding cover 132. Impact protection is further enhanced by a portion of the metal electronic housing 104 existing within the opening defined by the antenna 106 and the shield 130. This impact protection is particularly useful in cases where the antenna consists of coils printed on a substrate, as this type of antenna can be fragile.

[0046] For example Figure 10-13As shown and as described above, an exemplary electronic housing 104 surrounds a PCB 110 and an MRI-compatible magnet assembly 112. For this purpose, an electronic housing base 134 includes an end wall 178 and a side wall 180 defining an internal volume 182. The PCB 110 is located within the internal volume. The electronic housing base 134 also includes a cylindrical member 184 that, together with a portion of the end wall 178, forms a base portion of the magnet housing (discussed below with reference to Figures 16-18), within which the magnet assembly 112 is located. An electronic housing cover 136 includes a cylindrical member 186 and a disk 188 (Figures 16-18) forming a cover portion of the magnet housing. The cylindrical members 184 and 186 together define a cylindrical wall of the magnet housing. The disk 188 also defines a ground contact 128. The magnet assembly 112 is located within the magnet housing, and the magnet assembly and the associated housing together form an MRI-compatible magnet device.

[0047] Regarding the aforementioned access to the feedthrough 158 in the illustrated embodiment, the wall 178 of the housing base 134 includes a feedthrough access opening 190 aligned with the feedthrough. After the antenna 106 and lead wires are connected to the feedthrough 158 as described above, the feedthrough cover 192 may be welded or otherwise secured to the wall 178.

[0048] An exemplary PCB 110 includes a non-conductive substrate 194 (with conductive traces and pads (not shown)), a stimulation processor 196 on the substrate, and various other electronic components (e.g., integrated circuits and electrical connectors). The stimulation processor 196 converts stimulation data received by means of antenna 106 into stimulation currents. PCB 110 can be configured to accommodate a cylindrical member 184. In the illustrated embodiment, the PCB substrate 194 includes a notch 198 that allows an associated portion of the substrate to extend around the cylindrical member 184 and into a feedthrough 158. PCB 110 can be connected to a feedthrough pin 162 via contacts (FIG. 8) bonded to PCB 110, for example, with conductive epoxy resin.

[0049] This EA component 102 may include one or more rotatable magnets located within an electronics housing 104. The configuration of the magnets and the manner in which they are housed within the electronics housing 104 allow the magnets to rotate to align with a main magnetic field. An exemplary implementation of the magnet assembly is described below. This example and other examples of rotatable MRI-compatible magnet configurations are described in more detail in reference to U.S. patents numbered 2018 / 0110985, 2018 / 0369586, 2018 / 0296826, and 2019 / 0076649, and PCT patent publication number WO2018 / 199936, which are incorporated herein by reference.

[0050] Referring to Figures 14-16, the exemplary magnet assembly 112 includes a magnet frame 200 and a plurality of elongated radially magnetized magnets 202 located within the frame defining an N-S direction. Exemplary cylindrical members 184 and 186 of the electronics housing 104 define a central axis A1 (which is also the central axis of the magnet frame 200), and the magnet frame is rotatable 360° relative to the electronics housing about the central axis A1. The magnets 202 rotate together with the magnet frame 200 about the central axis A1. Each magnet 202 is also rotatable 360° relative to the magnet frame 200 about its own longitudinal axis A2 (also referred to as "axis A2"). In the illustrated embodiment, the plurality of longitudinal axes A2 are parallel to each other and perpendicular to the central axis A1. In other embodiments, the magnets within the magnet assembly may be oriented such that their longitudinal axes are at least substantially perpendicular to the central axis A1. As used in this article, an axis “at least substantially perpendicular to the central axis” includes both axes that are perpendicular to the central axis and axes that are slightly not perpendicular to the central axis (i.e., axes that deviate from the vertical by a maximum of 5 degrees).

[0051] An exemplary magnet frame 200 includes a disk 204 and a magnet container 206 extending completely through the disk. While the invention is not limited to any particular number, the exemplary magnet assembly 112 contains four elongated radially magnetized magnets 202. Two of the other identical magnets 202 are relatively long, and two are relatively short, to efficiently utilize the available volume. The shape of the container 206 corresponds to the overall shape of the assembly of magnets 202. Suitable materials for the frame 200 (which may be formed by machining or injection molding) include paramagnetic metals, polymers, and plastics. Suitable materials for the magnets 202 include, but are not limited to, neodymium-boron-iron and samarium-cobalt.

[0052] When exposed to the main MRI magnetic field, the torque on magnet 202 will cause the magnets to rotate about their axis A2 as needed to align the magnetic field of the magnets with the MRI magnetic field. Magnet frame 200 will also rotate about axis A1 as needed to align the magnetic field of magnet 202 with the MRI magnetic field. When magnet assembly 112 is removed from the MRI magnetic field, the magnetic attraction between magnets 202 will cause the magnets to rotate about axis A2 back to the orientation shown in Figure 16, where they are aligned with each other in the NS direction, and the NS orientation of the magnets is perpendicular to the central axis A1.

[0053] To facilitate rotation of the magnet frame 200 and / or the magnet 202, a friction-reducing lubricating material can be provided between the device housing 104 and the magnet frame and / or between the magnet and the device housing and the magnet frame. For example, a lubricating layer 208 can be added to all the various surfaces of the frame 200 (as shown). In other embodiments, a lubricating layer can be added to the inner surface of the device housing 104 that contacts the magnet assembly 112. The lubricating layer 208 can be in the form of a specific surface finish that reduces friction compared to an unpolished surface, or it can be a lubricating material such as diamond-like carbon (DLC), titanium nitride (TiN), PTFE, polyethylene glycol (PEG), parylene, fluorinated ethylene propylene (FEP), and other products marketed under trade names. The coating is a chemically plated nickel (and sold by Nedox PFTM). For example, a DLC coating may be only 0.5 to 5 micrometers thick. Alternatively or additionally, magnet 202 may be located within tube 210 formed of a low-friction material. Suitable materials for tube 210 include polymers (such as silicone, PEEK and other plastics, PTFE and PEEK-PTFE mixtures) and paramagnetic metals. Magnet 202 may be fixed to tube 210 such that each tube and associated magnet can rotate about its axis A2, or the magnet may be free to rotate relative to the tube. The magnet / tube combination is also mechanically more robust than a magnet alone. Instead of tube 210, magnet 202 may be coated with the lubricating material discussed above.

[0054] Referring now to Figures 16-18, and as described above, the various portions of the electronic device housing 104 are assembled to form a magnet housing 212 in which the magnet assembly 112 is located, thereby storing the magnet assembly within an internal volume 182 of the electronic device housing in a manner that isolates the magnet assembly from the electronics within the internal volume. The exemplary magnet housing 212 has a base portion 214 formed by a portion of the cylindrical member 184 and an end wall 178 bonded to the cylindrical member 184, and a cover portion 216 formed by a cylindrical member 186 and a disk 188. The base and cover portions 214 and 216 together define an internal volume 218 for the magnet assembly 112, which is sealed with an O-ring seal 220 or other suitable tool. This seal prevents contaminants associated with the rotating portion of the magnet assembly 112 from entering the portion of the internal volume 182 of the electronic device housing where the PCB 110 is located.

[0055] It should also be noted that in the illustrated embodiment, the magnet assembly 112 is permanently fixed within the electronic device housing 104. As used herein, the magnet assembly is "permanently fixed within the electronic device housing" once the electronic device housing is welded to or otherwise sealed closed with the electronic components and magnet assembly therein, and the magnet assembly cannot be removed from the electronic device housing without damaging at least a portion of the housing (e.g., the housing base and / or housing cover) and / or the welds sealing the housing or other tools.

[0056] Another exemplary cochlear implant in Figure 19 and Figure 20 The cochlear implant 100a is generally indicated by reference numeral 100a. The cochlear implant 100a is substantially similar to the cochlear implant 100, and similar components are indicated by similar reference numerals. For example, the cochlear implant 100a includes: an electronics and antenna assembly (“EA assembly”) 102a having an electronics housing 104a and an antenna 106 mounted to the top of the electronics housing; and a cochlear lead wire 108. The antenna 102 and lead wire can be connected to a PCB within the electronics housing 104a in the manner described above. An MRI-compatible magnet assembly (such as magnet assembly 112) can be housed within the electronics housing in the manner described above. Additionally, the top, bottom, and sides of the EA assembly 102a may be covered by an overmolded member 120, which includes a housing cover portion 122 and a strain relief portion 124, and a portion of the electronics housing 104a is exposed through an opening 126 in the overmolded member to define a ground contact 128.

[0057] Turn Figure 21 and Figure 22 The exemplary EA assembly 102a also includes an annular electromagnetic shield 130a located between the electronics housing 104a and the antenna 106, and a circular antenna / shielding cover 132a above the antenna and the electromagnetic shield. The exemplary electronics housing 104a includes the aforementioned housing base 134 and housing cover 136a, which surround the PCB 110 and the MRI-compatible magnet assembly 112 and can be secured to each other in the manner described above. The housing cover 136a is configured to receive the electromagnetic shield 130a, the antenna 106, and the antenna / shielding cover 132a. Specifically, the housing cover 136a includes an annular notch (or “external volume”) 142a, which is sized and shaped to receive the electromagnetic shield 130a, the antenna 106, and the antenna / shielding cover 132a. The notch 142a is defined by an annular end wall 138a, a portion of a side wall 140, a semi-circular wall 141a, and a cylindrical member 186. The second end wall 139a occupies the area between the semi-circular wall 141a and the side wall 140.

[0058] An exemplary electromagnetic shielding member 130a (which may be formed of a high-permeability material such as described above) includes an annular plate 166a configured (i.e., designed in size and shape) to fit into a recess 142a and an opening 168 for a cylindrical member 186. An annular groove 170 is provided for the antenna coil 144 and the substrate 146, while an opening 172 is provided for the antenna tab 148 and aligned with openings 154 and 156.

[0059] An exemplary antenna / shielding cover 132a has a configuration corresponding to that of the electromagnetic shielding 130a, and therefore includes a circular plate 174a, which is also configured to fit into a recess 142a and above the antenna 106 and the electromagnetic shielding 130a. An opening 176 extends through the plate 174a to receive a cylindrical member 186. Here, the antenna / shielding cover 132a also protects the antenna 106 and the electromagnetic shielding 130a and seals the non-biocompatible electromagnetic shielding within the EA assembly 102a. Suitable materials for the cover 132a include PEEK or other suitable high-strength materials.

[0060] Turn Figure 23 An exemplary cochlear implant system 60 includes a cochlear implant 100, a sound processor (such as the body-worn sound processor 300 or a behind-the-ear sound processor shown) and a headpiece 400.

[0061] An exemplary body-worn sound processor 300 in the exemplary ICS system 60 includes a housing 302 in which various components are supported and / or on the housing. Such components may include, but are not limited to, a sound processor circuitry 304, a headband port 306, an assistive device port 308 for an assistive device such as a mobile phone or music player, a control panel 310, one or more microphones 312, and a power container 314 for a removable battery or other removable power source 316 (e.g., rechargeable and disposable batteries or other electrochemical batteries). The sound processor circuitry 304 converts electrical signals from the microphones 312 into stimulation data. An exemplary headband 400 includes a housing 402 and various components carried by the housing (e.g., an RF connector 404, a microphone 406, an antenna (or other transmitter) 408, and a positioning magnet 410). The headband 400 can be connected to the sound processor headband port 306 via a cable 412. The positioning magnet 410 is attracted to the magnet assembly 112 of the cochlear stimulator 100, thereby aligning the antenna 408 with the antenna 106. Stimulation data, and in many cases, power, is supplied to the headpiece 400. The headpiece 400 transmits the stimulation data, and in many cases, power, percutaneously to the cochlear implant 100 via a wireless link between antennas. The stimulation processor 196 converts the stimulation data into a stimulation signal that stimulates the contacts 118 of the electrode array 116 on the lead 108. Figure 2 ).

[0062] In at least some embodiments, cable 412 will be configured for a 49 MHz forward telemetry and power signal and a 10.7 MHz reverse telemetry signal. It should be noted that in other embodiments, communication between the sound processor and the head-mounted device and / or auxiliary equipment can be achieved via wireless communication technology. Additionally, assuming the presence of microphone 312 on the sound processor 300, microphone 406 may be omitted in some cases. The functions of the sound processor 300 and the head-mounted device 400 can also be combined into a single head-mounted sound processor. Examples of head-mounted sound processors are illustrated and described in U.S. Patents Nos. 8,811,643 and 8,983,102, the entire contents of which are incorporated herein by reference.

[0063] Although the invention disclosed herein has been described with reference to the preferred embodiments described above, many modifications and / or additions to the preferred embodiments will be apparent to those skilled in the art. For example, the invention also includes any combination of elements from various kinds and embodiments disclosed in the specification that are not described. It is intended that the scope of the invention be extended to all such modifications and / or additions, and the scope of the invention is limited only by the claims set forth below.

Claims

1. An electronic device and antenna assembly for use in a medical implant, the electronic device and antenna assembly comprising: A metal electronic device housing having an internal volume, sidewalls, endwalls, and an external recess defined by the sidewalls and endwalls; Electronic components located within the internal volume; An antenna / shielding cover located within the external groove and formed of a first material; An antenna coil located within the external groove and between the end wall and the antenna / shielding cover; as well as An electromagnetic shielding element located within the external groove between the antenna and the end wall, the electromagnetic shielding element being formed of a second material different from the first material, and defining an annular shielding groove therein in which the antenna coil is located.

2. The electronic device and antenna assembly according to claim 1, wherein: The metal electronic device housing includes a titanium electronic device housing.

3. The electronic device and antenna assembly according to claim 1 or claim 2, wherein: The electromagnetic shielding component is formed of a material with high magnetic permeability.

4. The electronic device and antenna assembly according to claim 3, wherein: The high permeability is 25 to 250.

5. The electronic device and antenna assembly according to claim 1 or claim 2, wherein: The electromagnetic shielding component is 0.1 mm to 1.5 mm thick.

6. The electronic device and antenna assembly according to claim 1 or claim 2, wherein: The antenna coil is on an annular non-conductive substrate with a defined opening; The metal electronic device housing includes a magnet housing; At least one rotatable magnet is located inside the magnet housing; and A portion of the magnet housing extends through an opening in the non-conductive substrate.

7. The electronic device and antenna assembly according to claim 6, wherein: The at least one rotatable magnet is permanently fixed inside the metal electronic device housing.

8. The electronic device and antenna assembly according to claim 6, wherein: The magnet housing defines a central axis; and The at least one rotatable magnet includes a plurality of elongated radially magnetized magnets located in a magnet frame rotatable about a central axis of the housing, and the elongated radially magnetized magnets define a longitudinal axis and an N-S direction and are rotatable relative to the magnet frame about the longitudinal axis.

9. The electronic device and antenna assembly according to claim 6, wherein: The elastomer covers a portion of the housing of the shielding component, antenna, and metal electronic devices. The metal electronic device housing, antenna, shielding component, and elastomer together occupy the first volume; The magnet housing includes an interior defining a second volume; and The ratio of the first volume to the second volume is less than or equal to 9.

7.

10. The electronic device and antenna assembly according to claim 9, wherein: The ratio of the first volume to the second volume is less than or equal to 9.7 and greater than or equal to 6.

1.

11. The electronic device and antenna assembly according to claim 1 or claim 2, wherein: The metal electronic device housing includes a first end wall and a second end wall, the first end wall and the second end wall facing each other and defining the internal volume therebetween; The magnet housing is located within the electronic device housing and includes a portion of the first end wall, a portion of the second end wall, and a cylindrical wall located between the portion of the first end wall and the portion of the second end wall; The electronic components within the internal volume are located outside the magnet housing; as well as At least one rotatable magnet is located inside the magnet housing.

12. The electronic device and antenna assembly according to claim 11, wherein: The at least one rotatable magnet is permanently fixed inside the metal electronic device housing.

13. The electronic device and antenna assembly according to claim 11, wherein: The magnet housing defines a central axis; and The at least one rotatable magnet includes a plurality of elongated radially magnetized magnets located in a magnet frame rotatable about a central axis of the housing, and the elongated radially magnetized magnets define a longitudinal axis and an N-S direction and are rotatable relative to the magnet frame about the longitudinal axis.

14. The electronic device and antenna assembly according to claim 11, wherein: The elastomer covers a portion of the housing of the shielding component, antenna, and metal electronic devices. The metal electronic device housing, antenna, shielding component, and elastomer together occupy the first volume; The magnet housing includes an interior defining a second volume; and The ratio of the first volume to the second volume is less than or equal to 9.

7.

15. The electronic device and antenna assembly according to claim 14, wherein: The ratio of the first volume to the second volume is less than or equal to 9.7 and greater than or equal to 6.

1.

16. The electronic device and antenna assembly according to claim 1 or claim 2, wherein: The electronic components located within the internal volume include a cochlear implant stimulation processor.

17. A cochlear implant, comprising include: The electronic device and antenna assembly according to claim 1 or claim 2; and A cochlear lead with an electrode array operatively connected to the cochlear implant stimulation processor.

18. A cochlear implant comprising: The electronic device and antenna assembly according to claim 1 or claim 2, with an internal magnet housing; An elastomer covering at least a portion of the electronic device and antenna assembly; and Cochlear leads connected to the electronic devices and antenna assembly; in: The electronic devices, antenna assembly, and elastomer occupy the first volume; The magnet housing includes an interior defining a second volume; and The ratio of the first volume to the second volume is less than or equal to 9.

7.

19. The cochlear implant according to claim 18, wherein: The ratio of the first volume to the second volume is less than or equal to 9.7 and greater than or equal to 6.1.

Images