Patent Application
20250058129
Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
In an exemplary embodiment, there is a device, comprising a housing and a magnet in the housing, wherein the device is an implantable medical device, there is a clearance between an interior of the housing and the magnet in a direction of a longitudinal axis of the housing and/or in a direction normal to the longitudinal axis, the device is configured to independently at least temporarily hold the magnet in direct contact with a portion of the housing and/or a body connected to the portion of the housing, the portion being made of the same material and/or having a configuration and/or structure that is at least similar as a portion of the housing on an opposite side of the housing from the portion of the housing, and the device is configured to enable the magnet to rotate inside the housing when the magnet is subjected to a torque from a magnetic field. In an embodiment, the material is not the same and/or the configuration is not similar and/or the structure is not similar. In an embodiment, the material is a shim (made from a ferromagnetic material by way of example) located on one side of the housing and not on the other, and thus the material is not the same.
In an exemplary embodiment, there is a device, comprising a housing and a planar magnet in the housing, establishing a magnet-housing assembly, wherein the device is an implantable medical device, and the magnet-housing assembly is configured with an anti-rattle apparatus to reduce a rattling effect of the magnet vis-à-vis contact with the magnet and the housing while enabling the magnet to rotate about a structural longitudinal axis of the magnet while the magnet is in the housing.
In an exemplary embodiment, there is a method, comprising executing a rhythmic activity that imparts a rhythmic series of forces onto an implanted magnet implanted in a head of a human as part of an implanted device during a first temporal period, the implanted magnet being hermetically sealed in an implanted housing implanted in the head of the human, wherein movement of a center of mass of the magnet in the housing is limited by the implanted device, the magnet being free of magnetic interaction with a magnetic field external to the human and attaching and wearing an external component of a sensory prosthesis during a second temporal period separate from the first temporal period, at least a portion of the external component being held against the head of the human by magnetic attraction with the implanted magnet to execute the attaching and wearing, wherein the center of mass of the magnet moves relative to the housing during the action of attaching away from where the center of mass was located when movement of the center of mass was limited, and in some embodiments, the movement is towards the external component. But note that embodiments herein can have utilitarian value to non-rhythmic events as well, such as an activity that creates a repeated forces but is irregular/arhythmic. Thus, embodiments can be directed to dynamic activities by way of example.
In an exemplary embodiment, there is a device, comprising a housing and a magnet, wherein the magnet is hermetically sealed in the housing, the magnet and the housing establishing a magnet-housing assembly, wherein the device is configured to provide relievable contact of the magnet relative to a portion of the magnet-housing assembly via magnet attraction between the magnet and a magnetic component of the device, the device is an implantable medical device, the device is configured to retain an external component via transcutaneous magnetic attraction established at least in part by the magnet, and the device is configured so that the relievability of the contact is established upon the establishment of the transcutaneous magnetic attraction.
In an exemplary embodiment, there is a sensory prosthesis medical device, comprising a housing, the housing including a cylindrical hollow portion, a planar disk-shaped magnet in the cylindrical hollow portion, establishing a magnet-housing assembly and an RF inductance coil concentric with the magnet, wherein the magnet-housing assembly includes a shim made of magnetic material, the shim located closer to one flat side of the cylindrical hollow portion than an opposite flat side of the cylindrical hollow portion, the device biases the magnet towards the one flat side owing to magnetic attraction between the magnet and the shim, and the magnetic attraction is an anti-rattle feature of the device.
Merely for ease of description, the techniques presented herein are sometimes described herein with reference to an illustrative medical device, namely a cochlear stimulator, and in other instances, a cochlear implant. However, it is to be appreciated that the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from setting changes based on the location of the medical device. For example, the techniques presented herein may be used with other hearing prostheses, including acoustic hearing aids, bone conduction devices, middle ear auditory prostheses, direct acoustic stimulators, other electrically simulating auditory prostheses (e.g., auditory brain stimulators), etc. Some embodiments include the utilization of the teachings herein to treat an inner ear of a recipient that has and/or utilizes one or more of these devices. The techniques presented herein may also be used with vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation, etc. In further embodiments, the techniques presented herein may be used with air purifiers or air sensors (e.g., automatically adjust depending on environment), hospital beds, identification (ID) badges/bands, or other hospital equipment or instruments.
The teachings detailed herein can be implemented in sensory prostheses, such as hearing implants specifically, and neural stimulation devices in general. Other types of sensory prostheses can include retinal implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings in/with a hearing implant and in/with a retinal implant, unless otherwise specified, providing the art enables such. Moreover, with respect to any teachings herein, such corresponds to a disclosure of utilizing those teachings with all of or parts of a cochlear implant, cochlear stimulator, a bone conduction device (active and passive transcutaneous bone conduction devices, and percutaneous bone conduction devices) and a middle ear implant, providing that the art enables such, unless otherwise noted. To be clear, any teaching herein with respect to a specific sensory prosthesis corresponds to a disclosure of utilizing those teachings in/with any of the aforementioned hearing prostheses, and vice versa. Corollary to this is at least some teachings detailed herein can be implemented in somatosensory implants and/or chemosensory implants. Accordingly, any teaching herein with respect to a sensory prosthesis corresponds to a disclosure of utilizing those teachings with/in a somatosensory implant and/or a chemosensory implant.
Thus, merely for ease of description, the first illustrative medical device is a hearing prosthesis. Any techniques presented herein described for one type of hearing prosthesis or any other device disclosed herein corresponds to a disclosure of another embodiment of using such teaching with another device (and/or another type of hearing device including other types of bone conduction devices (active transcutaneous and/or passive transcutaneous), middle ear auditory prostheses (particularly, the EM vibrator/actuator thereof), direct acoustic stimulators), etc. The techniques presented herein can be used with implantable/implanted microphones (where such is a transducer that receives vibrations and outputs an electrical signal (effectively, the reverse of an EM actuator), whether or not used as part of a hearing prosthesis (e.g., a body noise or other monitor, whether or not it is part of a hearing prosthesis) and/or external microphones. The techniques presented herein can also be used with vestibular devices (e.g., vestibular implants), sensors, seizure devices (e.g., devices for monitoring and/or treating epileptic events, where applicable), and thus any disclosure herein is a disclosure of utilizing such devices with the teachings herein (and vice versa), providing that the art enables such. The teachings herein can also be used with conventional hearing devices, such as telephones and ear bud devices connected MP3 players or smart phones or other types of devices that can provide audio signal output, that use an EM transducer. Indeed, the teachings herein can be used with specialized communication devices, such as military communication devices, factory floor communication devices, professional sports communication devices, etc.
By way of example, any of the technologies detailed herein which are associated with components that are implanted in a recipient can be combined with information delivery technologies disclosed herein, such as for example, devices that evoke a hearing percept, to convey information to the recipient. By way of example only and not by way of limitation, a sleep apnea implanted device can be combined with a device that can evoke a hearing percept so as to provide information to a recipient, such as status information, etc. In this regard, the various sensors detailed herein and the various output devices detailed herein can be combined with such a non-sensory prosthesis or any other nonsensory prosthesis that includes implantable components so as to enable a user interface, as will be described herein, that enables information to be conveyed to the recipient, which information is associated with the implant.
More particularly, sound input device 126 converts received sound signals into electrical signals. These electrical signals are processed by the sound processor. The sound processor generates control signals that cause the actuator to vibrate. In other words, the actuator converts the electrical signals into mechanical force to impart vibrations to skull bone 136 of the recipient.
Bone conduction device 100 further includes coupling apparatus 140 to attach bone conduction device 100 to the recipient. In the example of
It is noted that sound input element 126 can include devices other than a microphone, such as, for example, a telecoil, etc. In an exemplary embodiment, sound input element 126 can be located remote in a BTE device (not shown) supported by the ear and in communication with the bone conduction device 100 via a cable. Alternatively, sound input element 126 can be subcutaneously implanted in the recipient, or positioned in the recipient's ear canal or positioned within the pinna. Sound input element 126 can also be a component that receives an electronic signal indicative of sound, such as, from an external audio device. For example, sound input element 126 can receive a sound signal in the form of an electrical signal from an MP3 player or a smartphone electronically connected to sound input element 126.
The sound processing unit of the auditory prosthesis processes the output of the sound input element 126, which is typically in the form of an electrical signal. The processing unit generates control signals that cause an associated actuator to vibrate. These mechanical vibrations are delivered by an external portion of the auditory prosthesis 100, as described below.
The vibrating actuator 208 is a device that converts electrical signals into vibration. In operation, sound input element 126 converts sound into electrical signals. Specifically, the transcutaneous bone conduction device 200 provides these electrical signals to vibrating actuator 208, or to a sound processor (not shown) that processes the electrical signals, and then provides those processed signals to vibrating actuator 208. The vibrating actuator 208 converts the electrical signals into vibrations. Because vibrating actuator 208 is mechanically coupled to plate 212, the vibrations are transferred from the vibrating actuator 208 to plate 212. Implantable plate assembly 214 is part of the implantable portion 206, and is made of a ferromagnetic material that can be in the form of a permanent magnet, that generates and/or is reactive to a magnetic field, or otherwise permits the establishment of a magnetic attraction between the external portion 204 and the implantable portion 206 sufficient to hold the external portion 204 against the skin 132 of the recipient. Additional details regarding the magnet groups that can be utilized in both the external portion 204 and the implantable portion 206 are described in more detail herein. Accordingly, vibrations produced by the vibrating actuator 208 of the external portion 204 are transferred from plate 212 across the skin 132 to implantable plate 216 of implantable plate assembly 214. This can be accomplished as a result of mechanical conduction of the vibrations through the skin 132, resulting from the external portion 204 being in direct contact with the skin 132 and/or from the magnetic field between the two plates 212, 216. These vibrations are transferred without a component penetrating the skin 132, fat 128, or muscular 134 layers.
As can be seen, the implantable plate assembly 214 is substantially rigidly attached to bone fixture 220 in this embodiment. Implantable plate assembly 214 includes through hole 220 that is contoured to the outer contours of the bone fixture 218, in this case, a bone screw that is secured to the bone 136 of the skull. This through hole 220 thus forms a bone fixture interface section that is contoured to the exposed section of the bone fixture 218. In an exemplary embodiment, the sections are sized and dimensioned such that at least a slip fit or an interference fit exists with respect to the sections. Plate screw 222 is used to secure implantable plate assembly 214 to bone fixture 218. As can be seen in
Still with reference to
As can be seen in
It is noted that magnet apparatus 160 is presented in a conceptual manner. In this regard, it is noted that in at least some instances, the magnet apparatus 160 is an assembly that includes a magnet surrounded by a biocompatible coating. Still further by way of example, magnet apparatus 160 is an assembly where the magnet is located within a container having interior dimensions generally corresponding to the exterior dimensions of the magnet, although in other embodiments, this is not the case. This container can be hermetically sealed, thus isolating the magnet in the container from body fluids of the recipient that penetrate the housing (the same principle of operation occurs with respect to the aforementioned coated magnet). In an exemplary embodiment, this container permits the magnet to revolve or otherwise move relative to the container, as is known in the art. Additional details of the container will be described below. In this regard, it is noted that while sometimes the term magnet is used as shorthand for the phrase magnet apparatus, and thus any disclosure herein with respect to a magnet also corresponds to a disclosure of a magnet apparatus according to the aforementioned embodiments and/or variations thereof and/or any other configuration that can have utilitarian value according to the teachings detailed herein.
With reference now to
It is noted that
External component 440 includes a sound input element 126 that converts sound into electrical signals. Specifically, the transcutaneous bone conduction device 499 provides these electrical signals to vibrating actuator 452, or to a sound processor (not shown) that processes the electrical signals, and then provides those processed signals to the implantable component 450 through the skin of the recipient via a magnetic inductance link. In this regard, a transmitter coil 442 of the external component 440 transmits these signals to implanted receiver coil 456 located in housing 458 of the implantable component 450. Components (not shown) in the housing 458, such as, for example, a signal generator or an implanted sound processor, then generate electrical signals to be delivered to vibrating actuator 452 via electrical lead assembly 460. The vibrating actuator 452 converts the electrical signals into vibrations.
The vibrating actuator 452 is mechanically coupled to the housing 454. Housing 454 and vibrating actuator 452 collectively form a vibratory apparatus 453. The housing 454 is substantially rigidly attached to bone fixture 341.
As with the embodiments above, the external device 440 is held against the skin via magnetic attraction between a ferromagnetic body in the external device 440 and the implantable component 450, such as in the implanted receiver coil apparatus 456.
An image processor 1102 is in signal communication with the sensor-stimulator 1108 via cable 1104 which extends through surgical incision 1106 through the eye wall (although in other embodiments, the image processor 1102 is in wireless communication with the sensor-stimulator 1108). In an exemplary embodiment, the image processor 1102 is analogous to the sound processor/signal processors of the auditory prostheses detailed herein, and in this regard, any disclosure of the latter herein corresponds to a disclosure of the former in an alternate embodiment. The image processor 1102 processes the input into the sensor-stimulator 108, and provides control signals back to the sensor-stimulator 1108 so the device can provide processed and output to the optic nerve. That said, in an alternate embodiment, the processing is executed by a component proximate to or integrated with the sensor-stimulator 1108. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.
The retinal prosthesis can include an external device disposed in a Behind-The-Ear (BTE) unit or in a pair of eyeglasses, or any other type of component that can have utilitarian value. The retinal prosthesis can include an external light/image capture device (e.g., located in/on a BTE device or a pair of glasses, etc.), while, as noted above, in some embodiments, the sensor-stimulator 1108 captures light/images, which sensor-stimulator is implanted in the recipient. In an exemplary embodiment, there is a transcutaneous communication coil that is held against a skin of a recipient via magnetic attraction to communication with an implanted component, which implanted component provides the stimulation to evoke a sight precept. In an embodiment, the teachings herein regarding magnetic attraction are utilized in such.
In the interests of compact disclosure, any disclosure herein of a microphone or sound capture device corresponds to an analogous disclosure of a light/image capture device, such as a charge-coupled device. Corollary to this is that any disclosure herein of a stimulator unit which generates electrical stimulation signals or otherwise imparts energy to tissue to evoke a hearing percept corresponds to an analogous disclosure of a stimulator device for a retinal prosthesis. Any disclosure herein of a sound processor or processing of captured sounds or the like corresponds to an analogous disclosure of a light processor/image processor that has analogous functionality for a retinal prosthesis, and the processing of captured images in an analogous manner. Indeed, any disclosure herein of a device for a hearing prosthesis corresponds to a disclosure of a device for a retinal prosthesis having analogous functionality for a retinal prosthesis. Any disclosure herein of fitting a hearing prosthesis corresponds to a disclosure of fitting a retinal prosthesis using analogous actions. Any disclosure herein of a method of using or operating or otherwise working with a hearing prosthesis herein corresponds to a disclosure of using or operating or otherwise working with a retinal prosthesis in an analogous manner.
The teachings detailed herein can be used in any of the embodiments disclosed above and/or in other medical devices.
Magnetic flux generated by the magnets 308, 310, 314, 316 is also depicted in
Each magnet in each magnet group generates its own magnetic field (as will be detailed below, an exemplary embodiment is such that portions 308, 312 and 310 are portions of a monolithic magnet. Together, magnets 308, 310, 312, 314, 316, and 318 form a magnet group (and generate a group magnetic field), although subsets of these magnets (e.g., magnets 308, 310, 312 in the external portion 302; and magnets 314, 316, 318 in the implantable portion 304) can also form magnet groups (and their own group magnetic fields). Moreover, the magnets in each magnet group need not be physically separate components, but can be a unitary part having different magnetization directions, which can be accomplished by the magnetization process. The effect on the magnetic field is depicted in
Magnets having differing form factors and magnetization directions are contemplated. For example, magnets that are diametrically magnetized and magnets that are axially magnetized are contemplated for applications such as bone conduction devices, to maintain a low profile of the auditory prosthesis. In the depicted embodiment, magnets 308, 310, 314, and 316 are axially magnetized so as to have a magnetization direction normal to a transcutaneous interface (i.e., the interface between the external portion and the implantable portion). The magnets 312, 318 are magnetized through the width so as to have a magnetization direction transverse to the magnetization direction of magnets 308, 310, 314, and 316. In examples where a unitary magnet is used, the unitary magnet can be magnetized such that portions thereof are diametrically magnetized, while other portions thereof are axially magnetized. Moreover, each magnet of a given magnet group can physically contact magnets proximate thereto so as to form a continuous flux path within the medical device (or the implanted component), if desired. Other configurations are contemplated and described in more detail below.
The magnets 604a, 604b, 604e of the external magnet group are disposed in a circuit that defines a substantially continuous flux path through the external component. Magnetic flux is channeled along the flux path following the magnetization direction of the respective magnets: from the first end magnet 604a, through the intermediate third magnet 604e, to the second end magnet 604b. This reduces the incidence of stray magnetic flux adjacent the magnet 604e.
In an exemplary embodiment, the magnet group is configured such that the first magnet portion, the second magnet portion and the third magnet portion establish a device such that the first portion and the third portion are contiguous, and the second portion and the third portion are contiguous. In an exemplary embodiment, a cross-section of the magnet group lying on a plane perpendicular to a longitudinal axis of the magnet group contains only the gap for the hole 621, while, with respect to other embodiments that will be described below, there are no gaps. In some embodiments, the magnet group is configured such that the first magnet portion, the second magnet portion and the third magnet portion are portions that are solid portions In an exemplary embodiment, the magnet group is configured such that the first magnet portion, the second magnet portion and the third magnet portion are portions that have solid cross-sections when taken on a plane perpendicular to a longitudinal axis of the magnet group, and the second magnetic field extends normal to the first and third magnetic fields, and the second magnet portion extends from one side of the group to an opposite side of the group.
In an exemplary embodiment, there are only the three portions that make up the magnet group. In an exemplary embodiment, there are only 2, 3, 4, 5, or 6 portions that make up the magnet group.
The above said, in some embodiments, there is no hole through the magnet(s).
While the embodiments associated with some figures above have been described in terms of three separate magnet portions establishing the magnet group, other embodiments utilize a monolithic single magnet and/or a magnet that combines at least two of the portions into a monolithic component. In this regard,
While the embodiment of
Magnet 687 can be utilized as the implantable magnet in any of the embodiments described above and/or below. Moreover, the magnets of the various figures can be used as the magnet of the external component, and embodiments include, for example, a system with an implanted device and an external device, respectively having the various magnets disclosed herein in an arrangement such that the external device is attracted to the implanted device when the external device is worn against the head of the human. While focus on some embodiments will sometimes be described in terms of the utilization of magnet 687 in the implantable component of a medical device. It is noted that other embodiments can utilize other types of magnets such as those described herein and other types as well, and will often be described in terms of such. It is noted that any of the disclosure described above does not constitute structure corresponding to the innovative features of the present invention, but instead provides a framework for those teachings as will be described below. Accordingly, “means for” language does not cover those descriptions per se without one or more features of the below. That is not to say that the above is not used with “means for.” That is to say that, for example, a means for providing magnetic retention of an external component would not cover apparatus 160, but would cover apparatus 760 as will now be described.
And with respect to
Not shown in
The housing 710 hermetically isolates the magnet 686 that is located inside the interior cavity of the housing 710. The magnet 710 is depicted as being in contact with the housing wall at the top of the housing 710. This is owing to the magnetic attraction between the magnet 604 of the external component and the magnet 686. In this embodiment, the cavity of the housing 710 is dimensionally larger in all dimensions then the dimensions of the magnet 686. This means that there is a space between at least one longitudinal side of the magnet (top or bottom with respect to the view of
In this exemplary embodiment, the magnet apparatus 760 is configured to enable the magnet 686 to rotate about the longitudinal axis of the magnet 799. This is depicted by way of example only and not by way of limitation in
In embodiments of
The above said, the magnetic material could itself have a magnetization applied to the material so that it either attracts or repels the implant magnet. (The magnetization could be simple, such as two poles, or could be a flat magnet with repeating N/S poles. Any arrangement that can have utilitarian value to enable the teachings herein can be used. As will be detailed below, the material can be in the hermetic magnet casing, or outside the magnetic casing, or both, and all can be hermetically isolated from the environment. To be clear, the magnetic material (such as the shim disclosed herein) used to establish retention/attraction of the implanted manet to the housing can be magnetized or not magnetized. Any material that can be used to establish a magnetic attraction between the implant magnet and the housing or other portion of the implant can be used in some embodiments. A ferromagnetic material that is not magnetized can be used. Non-ferromagnetic material that can establish magnetic attraction can be used in some embodiments, providing that the art enables such.
In view of the above, it can be seen that in some exemplary embodiments, there are magnet apparatuses that are configured to retain the magnet thereof within a specific location within the housing thereof, while enabling the magnet to move. In this regard, by way of example only and not by way of limitation, embodiments where the magnet is normally held at the bottom of the housing owing to magnetic attraction between the magnet 686 and the housing (bottom wall of the housing) when the external component is not magnetically coupled to the implantable component, when the external component is brought into magnetic coupling with the implantable component so as to hold the external component proximate the implanted component, and so as to, for example, align the external communication coil with the implanted communication coil utilizing the magnetic polarities of the magnets, the magnet 686 could be pulled away from the bottom of the housing up to contact with the top of the housing. Upon removal of the external component from the person and thus the elimination of magnetic communication between the external magnet and implanted magnet, the magnetic attraction of the magnet 686 to the magnet material of the bottom of the housing would pull the magnet 686 downward (at least if the top wall was not a magnetic material, for example). It is briefly noted that the terms upward and downward are described with respect to the orientation shown in the figures. In reality, during use, the aforementioned upward and downward movements would in fact be from side to side because the cochlear implant and/or the active transcutaneous bone conduction device implant, or more specifically, the receiver coils and thus the magnets thereof, are typically located on the side of the head between the skull and the skin, and thus would be oriented 90° from the orientation shown in
The embodiments above have focused on the concept of at least a portion of the housing 710 of the magnet apparatus being made of a magnetic material, magnetized or otherwise. In an alternate embodiment, the housing 710 is not made of a magnetic material. Instead, the housing is made of a polymer such as PEEK or the like. In an embodiment, no part of the housing is made of a magnetic material. In an exemplary embodiment, no part of the housing is made of a metal material or otherwise includes a metal material. In an embodiment, the housing is made of titanium or portions of the housing can be made of titanium, at least nonmagnetic titanium alloy (in the event that a titanium alloy that is magnetic can be devised). In an exemplary embodiment, the tab 762 can be made of metal, or a grommet reinforcing hole 764 could be made of metal. In an exemplary embodiment, the tab is not metal. Indeed, in an exemplary embodiment, all outer portions of the magnet apparatus, and/or portions that could be exposed to body fluids, are made of nonmagnetic material or otherwise do not include magnetic material.
In an exemplary embodiment, the magnet apparatus could include a body made of a magnetic material, such as shim 770 as shown in
The shim can be a plate or a sheet of metal. A shim or body can be cut from a sheet, or segmented patterns could be made by adhering pre-cut forms (e.g., punched, laser cut, wire-cut, etc.), or could be made by selective material removal (e.g., laser ablation, chemical etching, machining, etc.). The bodie(s) of the magnetic material components can be fabricated according to any utilitarian manner. The bodies can be machined from a block of magnetic material to obtain the desired thicknesses and/or shapes.
In the embodiment shown in
In an embodiment, the shim (which is used herein as a proxy for any magnetic material arrangement that has utilitarian value-any disclosure of a shim corresponds to an alternate disclosure of a magnetic plate or a magnetic body) could be embedded into the housing. Alternatively, the magnetic material could be coated onto the raw titanium material of the housing wall (or other material of the housing wall) before the housing is manufactured. The material could be coated on after the housing wall at issue is formed. Possible processes of placing/securing the magnetic material include resistance welding, laser welding, sputtering (physical vapor deposition), chemical coating, explosive welding, ultrasonic welding, adhesives).
Values for D1 (the thickness of the shim) can be less than, more than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450, 500, 550, 600, 650, 700, 750, 700, 850, 900, 950, or 1000 microns, or any value or range of values therebetween in 0.1 micron increments, depending on the retention that is desired and/or depending on the size/strength of the magnet 686. Values for D7 (the housing wall thickness-shown is the top thickness, but the bottom can also be one of the values of D7 (the top need not be the same thickness as the bottom) can be any of the values for D1, starting at 20 microns (the values need not be the same-we are simply reusing the values in the interests of textual economy), as well as 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 mm, with any value or range of values in the increments for D7. The values of D3 can be any of the values of D7 (again, they need not be the same). Values for D8 (the maximum thickness of the magnet apparatus) can be 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 mm, or any values or range of values therebetween in 0.1 mm increments. Values for D2 can be any of the values of D6 (again, they need not be the same). D2 can be bigger than D6, or smaller. And as we detail below, embodiments can used shims that are non-circular (with respect to the top view). In such embodiments, D2 can be the maximum diameter. Moreover, there can be a plurality of D2 values (one for the maximum diameter, one for the minimum diameter (e.g., elliptical), for non-square rectangle, one for the long side and one for the short side, for a triangle, one D2 could be the height and one D2 could be the base, etc.). And note that in some embodiments, the values herein are values where a given component will fall within or be larger.
And we note that while embodiments herein are described mostly in terms of a round/circular magnet, disk shape magnet, other shapes can be used. For example, a pill shaped magnet and/or a racetrack shaped magnet can be used. A triangular, rectangular, elliptical shaped magnet can be used. Embodiments typically have at least one flat surface. In some embodiments, the surface has a maximum diameter of at least 50, 55, 60, 65, 70, 75, 80, 85, 90, 95 or 100% of the maximum diameter of the magnet.
Thus, it can be seen that in some embodiments, there is a clearance between an interior of the housing and the magnet in a direction of a longitudinal axis of the housing and/or the magnet, and/or in a direction normal to the longitudinal axis (the lateral direction) of the housing and/or the magnet. In an embodiment, this can enable (or more accurately, result in) movement in the longitudinal direction and/or in the lateral direction, respectively. Embodiments herein can utilize magnetic attraction in the various directions to limit/restrict movement in those directions (and/or directions normal to the various directions) that would or might otherwise exist because of the respective clearances (wherein limit/restrict includes preventing movement, at least under certain circumstances (such as under certain acceleration regimes)). In an embodiment, the clearance is all the way around the magnet when an interior of the housing and the magnet are concentric with one another, and the clearance has values with respect to the concentric arrangement less than and/or equal to and/or greater than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.5, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3 or 0.2% of the diameter of the interior of the housing measured normal to the longitudinal axis (both the diameter and the value). In an embodiment, the clearance between the magnet (including a coated magnet-a “magnet” covers the apparatus that is a magnet, which can be coated with a metal or some other material, and thus the clearance would be measured from the outer surface of the coating) and the opposite surface of the housing assembly, such as the housing wall, as measured along the longitudinal axis, when the magnet is located on one side of the housing assembly with respect to direction along the longitudinal axis (e.g., against one wall and away from the opposite wall), when the magnet is concentric as noted in the preceding sentence, can be less than and/or equal to and/or greater than 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.5, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3 or 0.2% of the diameter of the interior of the housing measured normal to the longitudinal axis of the housing (both the clearance and the diameter).
In some embodiments, where the housing is sufficiently thin and/or sufficiently flexible, the clearance could also be 0, as long as the magnet is still able to rotate in response to external forces. An exemplary embodiment of this use a vacuum in the hermetic portion of the housing, which pulls the flexible wall down on to the magnet to take up any clearances. (This could prevent or at least frustrate movement in the axial direction, but could permit movement in the radial direction).
In an exemplary embodiment, D12 is between 50 to 750 microns. D13 can be less than, more than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 11, or 12 or more mm, or any value or range of values therebetween in 0.01 mm increments. 1900 or 2000 microns or any value or range of values therebetween in 0.1 micron increments. D14 can be less than, more than or equal to 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, or 10 or 11 or 12 mm or more any value or range of values therebetween in 0.01 mm increments. D13 can be less than, more than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8, 9, or 10 or 11 or 12 or more mm or any value or range of values therebetween in 0.01 mm increments. 1900 or 2000 microns or any value or range of values therebetween in 0.1 micron increments. D3 can be less than, more than or equal to 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.5, 4, 4.5 or 5 mm or any value or range of values therebetween in 0.01 mm increments. D14 can be 5, 5.5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 mm or any value or range of values therebetween in 0.01 mm increments.
And it is noted that any of the dimensions/features of detailed for one embodiment can be for another embodiment provided that the art enables such, in some embodiments.
It is noted that any of the given dimensions applied to any given embodiment can be applicable to any of the other embodiments providing that the art enables such laws otherwise noted. For example, the dimensions D14 and D13 can be applicable to the embodiment of
As with the embodiments detailed above, the magnet apparatus 760 of
In an exemplary embodiment, the force of the implanted magnet against the shim or the housing wall or whatever support structure is positioned between the shim and the magnet, or the force between the rotating component and the non-rotating component, in the complete absence of any external magnetic force (such as the external magnet), when the longitudinal axis of the magnet is 90 normal to the direction of gravity, is less than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.3, 0.35, 0.4, 0.45, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9 or 2.0 Newtons or any value or range of values therebetween in 0.001 Newton increments (note that the values above 0.7 Newtons or so are likely for larger prostheses). (As will be detailed below, these forces can also be in the direction of gravity, such as where the magnetic component is laterally located, or not-more on this below). In an exemplary embodiment, an acceleration applied to the magnet in a direction opposite of the location of the shim or the housing wall or whatever support structure is positioned between the shim and the magnet, or the acceleration applied to the rotating component and the non-rotating component, in the complete absence of any external magnetic force (such as the external magnet), when the longitudinal axis of the magnet is 90 normal to the direction of gravity, is less than, equal to or greater than 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.5, 7 or 8 Gs, or any value or range of values therebetween in 0.05G increments, to have the magnet and/or center of gravity of the magnet move and/or have the magnet move from its zero G attracted position (otherwise, the magnet does not move owing to the friction forces).
And note that these values can also be the case for accelerations in a direction normal to the aforementioned direction of acceleration (e.g., in the direction of gravity when the magnet is held as just detailed-thus the friction between the major surfaces of the magnet and the housing assembly is sufficient to hold the magnet in place when subjected to one or more of these accelerations). And to be clear, the friction forces can be balanced so that rotation of the magnet a certain amount for magnetic alignment with the magnet of the external component occurs even if the magnet is in contact with the housing during the rotation. Embodiments include preventing and/or limiting the movements in the direction of the longitudinal axis and normal thereto while permitting rotation upon magnetic coupling of the external component with the implantable component. In an embodiment where there is movement, movement in a direction normal to the longitudinal axis is limited to no more than 80, 70, 60, 50, 40, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2, 1.5, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3 or 0.2% of a maximum clearance between the magnet and the housing measured normal to the longitudinal axis (both the diameter and the value).
In an exemplary embodiment, the force of the implanted magnet against the shim or the housing wall or whatever support structure is positioned between the shim and the magnet, or the force between the rotating component and the non-rotating component, in the complete absence of any external magnetic force (such as the external magnet), when the longitudinal axis of the magnet is normal to the direction of gravity, is less than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, or 80% of the force of the implanted magnet against the housing wall or the shim or whatever support structure is positioned between the magnet and the housing wall or the rotating component and the non-rotating component, all in the direction of the external magnet from the implanted magnet (which could be the same direction as the shim relative to the implanted magnet) due to the external magnet used with the external component being located against the skin facing housing wall (this could be tested by removing the magnet of the external component, and taking the housing out of the implanted component, and placing the external magnet against the housing with polarity being that which is the case during normal use) and/or with the external device being used with the implant with a simulated skin flap thickness and/or any one or more of the other control variables detailed above. In an exemplary embodiment, the force of the implanted magnet against the shim or the housing wall or whatever support structure is positioned between the shim and the magnet, or the force between the rotating component and the non-rotating component, in the complete absence of any external magnetic force (such as the external magnet), when the longitudinal axis of the magnet is 90 normal to the direction of gravity, is less than or equal to or greater than 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 125, 150, 175 or 200% of the force of the implanted magnet against the housing wall or the shim or whatever support structure is positioned between the magnet and the housing wall or the rotating component and the non-rotating component, all in the direction of the external magnet from the implanted magnet (which could be the same direction as the shim relative to the implanted magnet) due to the external magnet used with the external component being located against the skin facing housing wall (this could be tested by removing the magnet of the external component, and taking the housing out of the implanted component, and placing the external magnet against the housing with polarity being that which is the case during normal use) and/or with the external device being used with the implant with a simulated skin flap thickness and/or any one or more of the other control variables detailed above.
In an embodiment, an attractive force between the magnet 686 and the shim 770 remains substantially the same (which includes the same) or otherwise effectively the same or otherwise the force remains utilitarian regardless of the distance of the magnet from the shim (within the confines of the housing). For example, with respect to the arrangement of
In an exemplary embodiment, the magnetic strength between the implanted magnet and the external magnet with a skin flap thickness of 3, 4, 5, 6, 7, 8, 9, or 10 mm is between 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, or 600 Gauss. (Note that all examples herein can be with respect to the implanted component and the external component, so the magnets would be spaced even further owing to the silicone of the implant and the base of the external component, while all examples can be the magnet apparatus of the implant and the magnet (whether in a housing or not) of the external component.)
Magnets according to the embodiments of the teachings detailed herein will be arranged with respect to their polarity so as to attract each other during normal standard intended use. That is, the implanted magnet will be attracted to the external magnet, and vice versa. This will have the utilitarian effect of holding the external component, or at least the RF inductance coil thereof, against the skin of the recipient owing to the attraction between the two magnets. This is opposed to a scenario where the external RF inductance coil is placed upside down against the skin, where the magnets would repel each other.
According to embodiments of the teachings detailed herein, the rotational features permit the implanted magnet to rotate so that the magnet field thereof will align with the magnetic field of the external magnet. Granted, the external magnet may rotate itself owing to the movement of the person's hand as he or she places the external coil onto the skin/side of the head. The idea with the rotating magnet of the implant is that the magnet will rotate and otherwise align itself with the magnetic field of the external component. According to the embodiments detailed herein, the magnet can unlock or otherwise the friction forces that exist owing to the attraction of the implanted magnet with the shim can be sufficiently reduced if not completely eliminated so as to enable the rotation of the implanted magnet so that the magnetic flux thereof aligns with the external magnet or otherwise more closely aligns with the external magnet than that which would otherwise have been the case. In some embodiments or otherwise exemplary scenarios of use, the resulting angle A1 will be de minimis or otherwise can be zero. In some embodiments or at least some scenarios of use, the resulting angle A1 will always be less than 5 degrees. In some embodiments or at least some scenarios of use, resulting angle A1 will always be less than 10 degrees. In an exemplary embodiment, the resulting angle after rotation A1 will be less than and/or equal to 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170 or potentially 179 or degrees or any value or range of values therebetween in 0.1° increments. In an exemplary embodiment, the resulting reduction in the angle A1 will be at least, using the initial angle prior to alignment as the base angle, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99 or 100% or any value or range of values therebetween in 0.1% increments, owing solely to the rotation of the implanted magnet (that is, the external component does not rotate/the angle is measures relative to a dynamic system where the external component (or more accurately, the external magnet) is treated as the fixed element in the dynamic system vis-à-vis rotation. In an exemplary embodiment, the aforementioned percentages are what happens when there is a skin flap is 5 mm think, and the magnetic retention force is 0.25, 0.5, 0.75, 1, 1.25 or 1.5 Newtons or any value or range of values therebetween in 0.01 Newton increments, and the two magnets are aligned with their longitudinal axes perpendicular to the direction of gravity. Again, the external magnet does not rotate in this example. (The above performance features can be determined using a test rig, for example, with a simulated skin flap thickness, for example.) In an exemplary embodiment, the initial misalignment of the magnets (initial A1) is greater than and/or equal to 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, or 135, or any value or range of values therebetween in 0.1 degree increments, and the external magnet causes the implanted magnet to rotate by the aforementioned values. In an exemplary embodiment, there will be no rotation or at least there will be limited rotation if angle A1 is, for example, greater than 135, 140, 145, 150, 155, 160, 165, 170 or 175, depending on the embodiment, and then when A1 would be measured from the other side and again, greater than 135, 140, etc. The limited rotation could be no more than 5, 10, 15, 20, 25 or 30 degrees, depending on the embodiment.
The aforementioned performance features can be for one or more or all of the embodiments detailed herein in some embodiments (e.g., for the embodiment where the shim is located on the skull facing side of the housing, for the embodiment where the shim is located on the skin facing side of the housing, for an external and an implanted diametrically magnetized magnet where the magnetic flux through the disk magnets is normal to the longitudinal axes, for the magnet arrangement of
In an exemplary embodiment, when the magnet 686 (or 687) is in the position shown in
A utilitarian feature of utilizing the magnetic body/shim is that it can, in some embodiments, tend to hold the implant magnet in a utilitarian orientation between coil-off events (i.e., when the external component is removed, the magnet will likely couple in the correct orientation the next time, barring any large head accelerations and/or that the external component was significantly misaligned the last time or presently). In this regard, there could be scenarios where there are “dead spots.” For example, it could be that there are angular orientations of the magnet of the external component and the implant magnet where the implanted magnet will not rotate. For example, in an extreme case where the poles of the external magnet are aligned with the poles of the implant magnet (e.g., North over North and South over South when looking down the longitudinal axis), sufficient torque is not generated to cause the implanted magnet to rotate. If the shim prevents or otherwise limits the intra-external device use rotation of the implanted magnet (i.e., times between when the external components are attached to the implant, where there is no magnetic attraction from the external component on the implant magnet). The ideas that by limiting or otherwise preventing the rotation of the magnet, the rotational orientation of the magnet that was utilitarian with respect to establishing the magnetic coupling between the external component in the implant that holds the external component against the skin will be maintained between uses. Thus, the likelihood that a deleterious orientation between the external magnet and the implant magnet will occur is reduced because it is unlikely that the implant magnet will rotate between the times that the external component are attached to the side of the head of the recipient. Thus, embodiments can limit the rotation between uses to less than 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1 degrees, and/or limit rotation to 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1% of the rotation that would otherwise occur without the magnetic component, and/or improve concentricity between the external magnet and the implanted magnet by 30, 25, 20, 15, 10, 9, 8, 7, 6, 5, 4, 3, 2, or 1% that would otherwise be the case without the magnetic component, all other things being equal, or any value or range of values therebetween in 0.1 increments and this can occur over 1, 5, 10, 15, 20, 25, 30, 35, 40, 45 or 50 or more intra-external device usages, which can include recipient exercising and one or more the rhythmic activities detailed herein during those intra-external device usages, and thus there are methods that include such.
Thus, in an embodiment, there is utility in having a shim where the implant magnet is held in the correct or at least utilitarian orientation for the external device that includes the sound processor between coil-off events. This as opposed to the absence of the shim(s) where the implant magnet changes orientation when the external coil is removed. Embodiments can thus include methods where the recipient need not be instructed on having to move the external component in order to re-orient the external component, such as that which may be utilitarian with respect to orienting the microphones of the off-the-ear sound processor, or for BTE devices so the coil cable is oriented properly, given the limited length of the coil cable.
Embodiments such as that of
Note that in at least some exemplary embodiments, there are only two plates or even only one plate. Plate 1550 could instead be replaced by a housing wall that is monolithic with the sidewall component 1520 of the housing. Alternatively and/or in addition to this, only one of plates 1530 or 1540 are present. One plate/shell can have a recess machined/punched into the plate/shell to accept the shim or otherwise provide clearance for the shim. This could be on the outside or on the inside (or both, such as in embodiments where there are two or more shims, such as shims that are overlapping with respect to the longitudinal axis, which can be spaced away from each other by a plate 1540 or plate 1530 (and in some embodiments, a plurality of shims can be stacked one upon another directly in contact with each other—1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 or more shims can be used). In an exemplary embodiment, the sidewall component 1520 can have steps or graduations and the shells/plates can have different diameters. In an exemplary embodiment, only one of the shells/plates are welded or otherwise adhered to the remainder of the housing body. In some embodiments, two or more or all of the plates can be welded to the remainder of the housing body.
In this exemplary embodiment, at least wall 1540 is sized and dimensioned so as to enable utilitarian magnetic attraction of the magnet 686 with the shim 770. In an exemplary embodiment, the thickness of the walls 1540, 1530, and/or 1530 can correspond to the values of D11 above (the wall thicknesses can be different for two or all three walls). Different values can be utilized as well. While the embodiment just described utilizes titanium and/or titanium alloys to establish the walls, in another embodiment, a polymer such as PEEK or the like could be utilized to make one or more of the walls and/or the sidewall apparatus 1520. In an exemplary embodiment, wall 1540 can be made of a low friction material which could be different than the material of the other walls. While the embodiment described above indicated that the shim 770 could be adhered to the wall 1540 at the time of manufacture and/or before, in another embodiment, shim 770 could be instead adhered to the wall 1530. Also, while the embodiment shown utilizes flat circular plates, in an alternate embodiment, plate 1530 and/or 1540 could have a contoured arrangement that would accept the shim 770 and thus hold it in place with respect to the lateral direction. Conversely, crimping or the like can be utilized to secure the shim 770.
Further by way of example, plate 1540 by way of example could have some form of ridged structure such as that detailed above so as to reduce the surface area of the magnet that contacts the housing when the magnet 686 is attracted to the shim 770.
The dimensions and/or features detailed above with respect to the above embodiments can be applicable to the similarly situated features of the embodiment of
In view of the above, embodiments include a device, such as the implantable portion of a cochlear implant or an implantable portion of an active transcutaneous bone conduction device or the implantable portion of a middle ear implant, with the implantable portion of a retinal prosthesis for example (the device can be any sensory prosthesis in some embodiments that has an implant, for example), etc., comprising a housing, such as housing assembly 1910, or housing 710, and a magnet such as magnet 686 or 687, etc., in the housing. Collectively, this can establish a magnet apparatus, such as magnet apparatus 1960 or 760, etc. In this exemplary embodiment, consistent with the concept that the implantable component is in the implantable component of a hearing prosthesis, the device is an implantable medical device. Consistent with the embodiments above, there is a clearance (e.g., D12) between an interior of the housing and the magnet in a direction of a longitudinal axis of the housing. In this embodiment, the device is configured to at least independently (e.g., without another device such as the external component) temporarily hold the magnet in direct contact with a portion of the housing and/or a body connected to or otherwise in direct contact with the portion of the housing (shim 770 or the ridge or bearings, etc.), the portion being made of the same material and/or having a configuration and/or structure that is at least similar (e.g., similar wall thickness, similar diameter in the case of the wall plates 1530, 1540 and 1550, etc.) as a portion of the housing on an opposite side of the portion of the housing. Note that the shim is not part of the housing. Thus, in the embodiment where the shim is in the cavity of the housing, the portion would be the housing wall that supports the shim. In this embodiment, the device is configured to enable the magnet to rotate inside the housing when the magnet is subjected to a torque from a magnetic field.
In an embodiment, the device is configured to enable the magnet to rotate while holding the magnet in direct contact with the portion of the housing or the body connected to the portion of the housing. This can correspond to the embodiment of
In an embodiment, the device is configured to hold the magnet in direct contact with the portion of the housing. In an embodiment, the device is configured to prevent the magnet from directly contacting the portion of the housing.
In an embodiment, the device includes a magnetic material, such as the shim, to which the magnet is attracted, thus holding the magnet in contact with the portion. In an exemplary embodiment, the magnetic material is a magnet, while in another embodiment, the magnetic material is a non-magnet.
In an embodiment, the device includes a magnetic component, such as the shim 770, and the magnetic component is one of located outside an interior of the housing (e.g., such as the embodiment of
The magnetic material results in an application of a force that biases the implant magnet so that it is always pulled or pushed against one of the internal surfaces of the magnet casing or the material or a component between the casing and the magnet, so as to prevent free movement of the magnet in the casing in a longitudinal direction but enabling rotation (in some embodiments, rotation is also prevented) at least in the absence of the external component. The magnetic material can be a ferromagnetic material (for example, iron, nickel, steel, etc., any material to which the magnet can attract that will not have a deleterious result can be used in some embodiments).
Moreover, consistent with the use of the device in the head, of a human, the device has a skull facing side and a skin facing side and the portion is on the skull facing side. In an embodiment, where the device includes a magnetic material, such as the shim, in addition to the magnet, the magnet is attracted (or the magnet is repelled form the magnetic material, in another embodiment), thus holding the magnet in contact with the portion, wherein the magnetic material is unmagnetized and/or does not impart a significant rotational alignment force onto the magnet. With regard to the latter feature, in the absence of other magnetic fields, such as the external magnet, the magnet can be oriented at any orientation in the housing. Put another way, if the magnet apparatus is shaken, permitting the magnet to unlock, when the magnet is relocked at the end of the shaking, the angular orientation of the magnet at the end of the shaken the will be determined by chaos theory. That is, no specific orientation will be favored over any other orientation at least with respect to the effects of the magnetic component.
In an exemplary embodiment, there is a device, such as any of the medical devises detailed herein. The device comprises a housing and a planar magnet located in the housing (ideally, hermetically sealed in the housing), establishing a magnet-housing assembly. The planar magnet can be a disk magnet as seen above. A planar magnet is a magnet that has a surface that has a major surface that has a plane (and thus, for example, not a spherical magnet or a cylindrical magnet). The magnet could be another type of magnet, as long as it has a plane (in other embodiments, the magnet is not a planar magnet). Consistent with the embodiments above, the device is an implantable medical device, and the magnet-housing assembly is configured with an anti-rattle apparatus to reduce a rattling effect of the magnet vis-à-vis contact with the magnet and the housing while enabling the magnet to rotate about a structural longitudinal axis (an axis defined by the structure (and is thus “imaginary”), as opposed to a magnetic axis for example—the magnetic axis can correspond/be concentric and be parallel with the structural longitudinal axis in some embodiments-embodiments do not require a spindle on which the magnet rotates, and this is not to what a structural longitudinal axis refers (but embodiments can include such)) of the magnet (e.g., axis 799) while the magnet is in the housing (albeit when the magnet is unlocked in some embodiments). In this regard, the shim 770 and the magnetic attraction of the magnet to the shim will cause the magnet to be held in place against the housing or the shim or the component between the housing. This will prevent the magnet from moving around in the housing, at least with respect to a direction parallel to the longitudinal axis (as will be detail below, embodiments also include magnetic attraction in the lateral direction as will be described below, although as noted above, in some embodiments, the housing sidewalls can be magnetic material). In any event, the idea is that when the magnet apparatus is exposed to a force, or more accurately, an acceleration and then deceleration/reverse acceleration, etc., if there is a clearance between the magnet and the housing according to one or more of the clearances detailed herein, and there is no shim or otherwise no material to which the magnet can be attracted, the magnet could move back and forth and otherwise bounce against the walls of the housing (side and/or lateral wall(s)) establishing the interior cavity. Conversely, if there is magnetic attraction of the magnet to the shim (or repulsion if the shim is magnetized for example), a higher acceleration will be required to result in the magnet moving away from the housing or otherwise away from whatever component the magnet is directly contacting owing to the magnetic attraction (or repulsion). The idea is that by establishing a sufficient attractive force that requires a higher acceleration relative to general accelerations that might be experienced during normal life (e.g., walking, running, standing up from sitting, sitting from standing up, shaking one's head in disagreement, nodding one's head in agreement, etc.), the magnet will remain in contact with the wall of the housing (or whatever component is there supporting/that contacts the magnet), and thus the magnet will not rattle. Of course, a sufficient amount of acceleration would cause at least a tick (a characterization of the sound of the magnet striking the wall of the housing if the magnet is free to move in the lateral direction for example). Thus, for example, say someone jumps into bed and lands on his or her side, there might be a tick-tick as the magnet moves away from the shim, hits the far wall of the housing, and then is reattracted back towards the shim, and hits the shim or the wall of the housing between the shim and the magnet, etc. Say someone engages in parachuting, or jumps from a tree limb 5 or 6 or 7 feet above the ground. There might be a tick-tick as the person lands (owing to the lateral movement of the magnet). However, typically, there will not be a repeated ticking/rattling. By way of example only and not by way of limitation, say a recipient is walking. Without the antirattle feature, every step might cause a tick. With the antirattle feature, there might never be any ticks, but in some embodiments or otherwise some scenarios, the only time there might be tick is when the recipient takes a hard step, such as when the recipient reaches the bottom of a flight of stairs, and then there might be the recovery tick, but that would be the end. This as compared to a magnet in a housing, where there is sufficient clearance for the magnet to rotate, where every time the person moves a sufficient amount/experiences an acceleration or deceleration of a sufficient amount, there is a tick. This tick would be noticeable if the recipient has normal hearing in the contra-lateral ear. The tick could be heard by a third party and/or be picked up by a microphone of the prosthesis (implanted or external microphone).
To be clear, the tick/rattle can occur owing to the movement of the magnet in the lateral direction and/or in the longitudinal direction.
Accordingly, in an exemplary embodiment, the devices systems and methods disclosed herein can include reducing the number of ticks and/or energy generated by the magnet apparatus owing to movement of the magnet by at least 70, 75, 80, 85, 90, 95 or 100% or any value or range of values therebetween in 1% increments over a given period of time where an activity is continuously executed. By way of example only and not by way of limitation, a period of time could be at least 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 minutes and the activity could be walking on flat asphalt while wearing tennis shoes at a rate of 1, 2, 3 or 4 miles per hour. Subjectively, the number of ticks could be reduced by 95% or for example or any of the aforementioned percentages in other scenarios or other embodiments, for that person, and objectively, the number of ticks/energy could be reduced by that percentage or any of the percentages just detailed for a person who is walking across asphalt that is flat wearing tennis shoes who is a 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 or 80 percentile human factors engineering (or any percentage therebetween or range of percentages in 1 percentage increments) male or female of 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 or 80 years of age or any value or range of values therebetween in one year increments as of Nov. 11, 2021, which person was born in the United States, European Union (or a current member state as of Nov. 11, 2021, or the predecessor of the current member state(s)), Australia, or the People's Republic of China. In an exemplary embodiment, the aforementioned performance features can be for any of the human factors engineering humans just detailed who is running (or jogging) at a rate of 3, 4, 5, 6, 7 or 8 miles per hour (all at a steady pace).
In an exemplary embodiment, the aforementioned rhythmic activity, such as walking, imparts lateral forces onto the magnet, which would cause the magnet to move in the lateral direction (normal to the longitudinal axis of the magnet), and thus cause the magnet to strike the lateral sides of the housing, and thus cause a ticking every time or most every time that the magnet strikes the housing. By designing the housing and the magnet and the shim so that the magnetic attraction between the shim and the magnet is such that there are sufficient friction forces on the magnet so as to prevent the magnet from moving in the lateral direction, the ticking can be reduced and/or eliminated. (This can be accomplished by, for example, limiting/reducing the movement(s) as noted above. by way of example only and not by way of limitation.) In this regard, the phenomenon is akin to how a magnet placed on a refrigerator maintains its position and does not fall downward owing to gravity. The magnetic attraction and the size and the shape of the magnet and the overall contact surface area between the magnet and the refrigerator and the friction coefficients of the material can prevent the magnet from sliding downward in the face of a 1G environment. (Indeed, every time a refrigerator door is shut, hard, the magnet may move slightly downwards, but over a year of opening and closing, the movement may be de minimus.) In some embodiments where the magnet can unlock, the magnet would be in the locked configuration. When the magnet is unlocked, and thus is free at least in part of contact between the surface to which it previously abutted owing to the magnetic attraction with the shim, the magnet can then rotate and align with the external device to the extent such rotation is needed, at least until the magnet reaches the opposite side of the housing. But note also that embodiments herein can have utilitarian value to non-rhythmic events as well, such as an activity that creates a repeated forces but is irregular/arhythmic (basketball would be an example, another example would be driving on a rough or unpaved road). Thus, embodiments can be directed to dynamic activities by way of example. Accordingly, the disclosure herein relating to rhythmic activities corresponds to an alternate disclosure of dynamic activities that are arhythmic, providing that the art enables such. And to be clear, the teachings herein are applicable to one off dynamic events (with respect to a given temporal period, such as 2, 3, 4 or 5 seconds).
Consistent with the teachings above, the anti-rattle apparatus can enable the magnet to move in the direction of the structural longitudinal axis (e.g., axis 799). And in some embodiments, the rattle/ticking is caused by movement of the magnet in that direction. This fact is not contradictory. The antirattle apparatus also temporarily prevents the magnet from moving in that direction as noted above, hence establishing the antirattle feature. The anti-rattle apparatus can enable the magnet to move in the direction of the structural longitudinal axis away from a bone facing side of the housing when the device is implanted in a human when an external device that transcutaneously interacts with the device is held against the human via magnetic interaction between the planar magnet and the external device.
Note that in at least some exemplary embodiments where magnetic material is located between the implanted magnet and the external component, the magnet will always be biased towards the skin, and thus upon placing the external component against the skin, there will be no tick because the magnet will not have to move from one side of the housing to the other side of the housing (away from the bone towards the skin) because the magnet will already be on the side of the housing that faces the skin. Conversely, there might be a slight tick when the magnetic material is located on the skull facing side of the housing when the external component is coupled to the implant owing to movement of the magnet from the skull facing side toward the skin facing side. Of course, this may not be noticeable to the person and certainly will not be rhythmic during almost all circumstances (other than playing around, one is not going to remove and then replace the external component against the head of the recipient in a manner that has a recognizable frequency).
Owing to the use of the magnetic body (shim), the anti-rattle apparatus relies on a magnetic attraction to pull the magnet towards a bone facing side of the housing when the device is implanted in a human, and/or the anti-rattle apparatus is configured to unlock the magnet upon an external device that transcutaneous interacts with the device coming into magnetic communication with the planar magnet. The anti-rattle apparatus enables the magnet to move in the direction of the structural longitudinal axis only upon an application of a minimum force of the values noted above in the longitudinal direction. And in some embodiments where the anti-rattle apparatus includes a magnetic material, the magnet interacts with the magnetic material to establish an anti-rattle feature of the anti-rattle apparatus and the magnetic material is physically separated from contact from the magnet. (Physical separation, as that phrase is utilized herein is not established by mere coating on the magnet or the magnetic material or because a thin layer of fluid might be located between the two. Physical separation can be established by the housing wall or by the ring that establishes the ridge or by the bearings.)
Note that the concept of antirattle does not mean that there is never any rattle. As used herein, antirattle is rattle prevention/limitation in a manner that is significant enough to eliminate most rattles that would otherwise exist during common experiences.
Consistent with the teachings above regarding diametrically polarized magnets, etc., the planar magnet in at least some embodiments has a magnetic polarity axis that is offset from the structural longitudinal axis. Still, embodiments can be utilized with an axial magnetized magnet. Embodiments can utilize a magnet that is not a spherical magnet.
Continuing with an explanation regarding a device that has a housing and a magnet, wherein the magnet is hermetically sealed in the housing, the magnet and the housing establishing a magnet-housing assembly, in an embodiment, the device is configured to provide relievable contact of the magnet relative to a portion of the magnet-housing assembly via magnet attraction between the magnet and a magnetic component of the device. Here, the shim or the ring with the ridge or the bearings, etc., can be part of the magnet-housing assembly. (Magnet-housing assembly can be the magnet apparatus 1960 for example, or can be magnet apparatus 760 of
In an embodiment, the magnet is a non-spherical magnet that has a magnetic polarity axis that is more diametrically magnetized than it is axially magnetized (e.g., as measured from the longitudinal axis, the magnetic flux enters and leaves the magnet at an angle 50 degrees or 60 degrees therefrom). The magnet-housing assembly can have an overall thickness that is no greater than 8 mm or 7 mm or 6 mm or 5 mm or 4 mm or 3 mm or 2 mm. And referring back to the portion of the magnet-housing assembly, the portion of the magnet-housing assembly is a wall of the housing or a component of the magnet-housing assembly separate from the magnet and stationary relative to the housing, the component of the magnet-housing assembly corresponding to the magnetic component. And further to the above, the magnetic component has a thickness that is less than 250, 200, 150, 100, 90, 80, 70, 60, 50, 40, 30 or 20 or 10 microns, and a diameter of less than 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm.
In an exemplary embodiment, the magnetic component is a circular plate having a rectangular cross-section in a plane lying on and parallel to the longitudinal axis, and a circular cross-section in a plane normal to the longitudinal axis. In an exemplary embodiment, the total mass of the magnetic component is less than, or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7.5, 7, 6.5, 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2, 0.1, 0.09, 0.08, 0.07, 0.06, 0.05 or 0.04 grams or any value or range of values therebetween in 0.001 gram increments. Embodiments typically have at least one flat surface. Different shaped magnetic components can be used, as will be describe below, but briefly, elliptical shaped plates/shims/bodies, triangular, hoop, square, rectangular, pentagon shaped plates/shims bodies can be used.
In an exemplary embodiment, the total mass of the magnet (or compilation of magnets) of the external device is less than, or equal to 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7.5, 7, 6.5, 6, 5.5 or 5 grams or any value or range of values therebetween in 0.01 gram increments. In an exemplary embodiment, the total mass of the implanted magnet (or complication of implanted magnets) less than, or equal to 7, 6.5, 6, 5.5, 5, 4.5, 4, 3.5, 3, 2.5, 2, 1.5, 1, 0.9, 0.8, 0.7, 0.6, 0.5, 0.4, 0.3, 0.2 or 0.1 grams or any value or range of values therebetween in 0.01 gram increments.
In an exemplary embodiment, there is only one magnetic component in the magnet apparatus. As will be described below, there can be two or more magnetic components. In an exemplary embodiment, the magnet apparatus is devoid of magnetic material other than the magnet and the magnetic component(s). In an exemplary embodiment, the aforementioned masses constitute all of the magnetic material of the magnet apparatus other than the magnet. That is, outside of the magnet, there is no more magnetic material than the aforementioned masses.
As noted above,
In an embodiment, the body 3311 is adhered to the housing 686 with an adhesive or by welding. Corollary to this is that instead, the body 3311 can be adhered to the magnet 686. In an embodiment, the body 3311 is not adhered to the housing or the magnet, and can “float” in a manner that would be analogous to how the magnet 686 floats (if the shim 770 was not there at least) in the housing 710.
The diameter (or more accurately, surface area) of the body 3311 (or the shim in an embodiment where the body has a larger diameter than the shim, and the shim is what creates the support area, where the body does not have sufficient rigidity to provide meaningful support outside the perimeter of the shim) can be set by design to set the desired friction effect, although alternatively, there could be cancellation because force per unit area increases as area decreases, and there is thus a cancellation effect. The material and/or the surface roughness can be set by design to set the desired friction effect. The combination of the two can be implemented to set the friction effect. Indeed, in an embodiment, the magnetization force between the shim and the magnet is also set to achieve a given friction feature. Thus, three variables (surface roughness, material characteristic and force) can be set by design to achieve a desired friction feature. That said, the magnetization force will, in at least some embodiments, be set for purposes of anti-rattle, etc. (anti-rattle will drive the magnetization design) as opposed to the friction feature, and other variables will be varied to achieve the friction feature.
A diameter of the body 3311 (the horizontal distance of
In an embodiment, the body 3311 is made by punching out a disk/from a thin sheet (a sheet having the thickness of the end body). In an embodiment, the disk is a solid body, while in other embodiments, there can be one or more holes therethrought, such as a hole in the center of the body. And note that while a body with a circular outer profile is presented herein, in an alternate embodiment, a different shape can be used, such as a square or an octagon or some form of polygon shape (the shape when viewed looking down the longitudinal axis of the magnet 686).
In an embodiment, the surface that contacts the magnet 686 is smooth so as to reduce friction.
In an embodiment, the body 3311 is made of PTFE or PEEK or Polyamide. Non-polymers with utilitarian friction properties that are non-magnetic can be utilized, such as phosphor bronze, etc. The material can be selected based on the desired friction features (some embodiments may want increased friction as a result of the use of the body relative to that which would otherwise be the case, as noted above and as will be detailed below). The body 3311 can be any polymer that can have utilitarian value, or any other material that can have utilitarian value. In an embodiment, a low friction material is used. Moreover, the body 3311 can be a body that will not cause “wear” on the magnet 686 (raw magnetic material or the coating thereof), which will create “dust” (wear particles) inside the housing.
The use of the body 3311 can provide a “tuned” arrangement that can enable the magnet 686 to rotate when exposed to an MRI field so that the magnet 686 can magnetically align with the magnetic field of the MRI when a recipient of a device having the magnet apparatus is exposed thereto, while also preventing or at least limiting the propensity of the magnet to move laterally (left-right/into-out of the page of
In at least some embodiments, the attraction force between the magnet 686 and the shim 770 is sufficiently high and the surface(s) at issue are such that the friction between the body 3311 and the magnet 686 or between the body 3311 and an inside of the housing wall (or both for a floating body 3311) prevents the magnet 686 from moving (or at least limits the movement) with respect to the G-forces noted herein. In an embodiment, the body 3311 creates an increased friction relative to that which would be the case if the magnet 686 was against the shim 770 or against the housing. In an embodiment, the friction force (or alternatively, a force needed to be applied to move the magnet in the housing) is increased by at least and/or equal to 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 200, 250, 300, 350, 400, 450, 500, 550 or 600% or more or any value or range of values therebetween in 1% increments relative to that which would be the case in the absence of the body 3311, all other things being equal (such as, for example, the distance between the shim 770 and the magnet 686 is the same). That said, in an embodiment, the friction force (or the force needed to move the magnet in the housing) is decreased by at least and/or equal to 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85 or 90% or more or any value or range of values therebetween in 1% increments relative to that which would be the case in the absence of the body 3311, all other things being equal.
While the embodiments shown have the body 3311 located on one side of the magnet 686, in other embodiments, there is a body 3311 located on both sides of the magnet 686, and the bodies can be identical or can be different from each other (different diameter, different thickness or different shape for example). Note further that embodiments can include layered bodies as well (two or more bodies can be stacked one on top of the other, and here too the bodies can be different from each other (different thickness and/or different diameter and/or different shape).
In view of the above, in an embodiment, there is a device, such as the implantable magnet apparatus detailed herein, that includes a friction body that is located between the magnet and the housing, in direct contact with the magnet. In an embodiment, there is a non-magnetic component that is located between the magnet 686 and the magnetic component (e.g., the shim 770), located inside the housing, that one of increases or decreases a force needed to be applied to the magnet to move the magnet in the housing relative to that which would be the case in the absence of the non-magnetic component. In some embodiments, it increases the force, and in other embodiments, it decreases the force.
In some exemplary embodiments, there is a method where the magnet remains stationary within the housing during the action of executing the rhythmic activity, and this is owing to a friction surface (e.g., established by the body for example) within the implanted housing. As used herein, a friction surface or friction component or friction body is a surface that is used to achieve a friction result (whether that be higher friction or lower friction). A friction surface/component/body does not mean high friction. In this embodiment, the magnet would not remain stationary within the housing during the action of executing the rhythmic activity in the absence of the friction surface, all other things being equal. In an embodiment, the rhythmic activity is any one or more of those detailed herein. In an embodiment, the rhythmic activity imparts an acceleration according to any one or more of the values detailed herein.
In an embodiment, the magnet remains stationary within the housing during the action of executing the rhythmic activity owing to a friction surface within the implanted housing, and the magnet would rotate within the housing when exposed to a torque of a certain value but would not rotate within the housing in the absence of the friction surface when exposed to that same torque.
In an embodiment, the portion of the magnet-housing assembly described herein is a polymer body located within the housing but separate from the housing. In an embodiment, it is part of the housing. In an embodiment, the portion of the magnet-housing assembly is a friction component (e.g., the body) of the magnet-housing assembly separate from the magnet and separate from a wall of the housing, the friction component of the magnet-housing assembly being located between the magnet and the magnetic component. As seen above, in an embodiment, the compartment containing the magnet has a “stack” of the shim, the body and the magnet, from bottom to top, and the shim can be adhered to the interior of the housing in an exemplary embodiment. In this embodiment, the magnet is in direct contact with a polymer body.
As noted above, in some embodiments, there is a physical separation present between the shim (or whatever magnetic material component is the case) and the magnet. here, this can be established by a non-magnetic body located in the housing, such as the body 3311. In an embodiment, the shim (or whatever magnetic material component is the case) is located in a compartment of the housing in which the magnet is located.
Embodiments include methods.
In an embodiment, the rhythmic activity is walking at least 50, 75, 100, 125, 150, 200, 250, 300, 350, 400, 450 or 500 feet on a level surface, walking up or down a flight of stairs or two or three or four flights of stairs. In an embodiment, the rhythmic activity is running instead of walking. In an embodiment, the rhythmic activity is any of those detailed herein with the given limitations.
In an embodiment, during the rhythmic activity, the implanted magnet is held away from a side of the housing facing outer skin of the human.
Method 2000 also includes method 2020, which includes attaching and wearing an external component of a sensory prosthesis during a second temporal period separate from the first temporal period, at least a portion of the external component being held against the head of the human by magnetic attraction with the implanted magnet to execute the attaching and wearing.
In some embodiments, during the action of attaching, the magnet rotates about a longitudinal axis due to interaction with a magnet of the external component. In an embodiment, the magnet rotates at least 30 degrees about its longitudinal axis. In an embodiment, the center of mass of the magnet moves relative to the housing during the action of attaching towards the external component and away from where the center of mass was located when movement of the center of mass was limited. This is the movement from
And note that rotation is not movement of the center of mass relative to the housing, at least not for symmetrical magnets, as a center of mass is a point, and the magnet would rotate about that point.
In an embodiment, the movement is greater than and/or less than and/or equal to 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 450 or 500 microns or any value or range of values therebetween in 0.1 micron increments.
In an embodiment, rotation is solely about one axis. There is no rotation about another axis. In an embodiment, any rotation about any other axis is de minimis.
In an embodiment, there can be rocking of the magnet about an axis normal to the longitudinal axis of the magnet. In an embodiment, there can also be rotation about the longitudinal axis of the magnet. Further, there can be rocking about a second axis normal to the axis normal to the longitudinal axis, where the second axis is also normal to the longitudinal axis.
In an embodiment, the magnet cannot rotate about an axis normal to the axis of rotation of the magnet/the longitudinal axis/the axis normal to the skull/skin/the external component when used, more than 30, 25, 20, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3, 2 or 1 degrees or any value or range of values therebetween in 0.1 degree increments (rotation being relative to the housing—the housing might rotate/twist/turn in some embodiments).
In some scenarios, during the rhythmic activity, the implanted magnet is held away from a side of the housing facing outer skin of the human and an opposite side of the housing from the side of the housing facing outer skin of the human. This can be done according to an embodiment further described below. However, in some scenarios, during the rhythmic activity, the implanted magnet is held away from a side of the housing facing outer skin of the human and/or held against an opposite side of the housing (or at least held against a component located on an opposite side of the housing) from the side of the housing facing outer skin of the human. In some scenarios, during the rhythmic activity, the implanted magnet is held away from a side of the housing facing outer skin of the human. In some embodiments, the holding is achieved by attraction of the magnet to a magnetic material at the side of the magnet.
In an exemplary embodiment, an acoustic energy level radiating from the housing is less than 40, 35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6 or 5 Decibels SPL or any value or range of values therebetween in 0.1 dB SPL increments during execution of the rhythmic activity. This can be a mean, median and/or mode value. This can be a maximum value. In an embodiment, the energy level is zero (e.g., because the magnet does not move-note that in some scenarios, the magnet moves but does not release and then contact from the interior of the cavity—the magnet could slide along the contacting surface and/or rotate, and that would not be zero dB, but would be a low energy level).
In an embodiment, the shim(s) 770 or whatever magnetic body is being utilized is of a structure (sized and dimensioned and made of a given material) that results in the shim being magnetically saturated by the magnet 686 (and corollary to this, the magnet 686 is such that the magnet magnetically saturates the shim). This is the case irrespective of the distance of the magnet from the shim and/or the material between the shim and the magnet. Thus, embodiments include a ferrous shim that is magnetically saturated by the magnet 686 (and is such without any other magnet being present-a magnet can be present, but the saturation is due entirely due to the magnet 686).
With respect to the cavity, in at least some exemplary embodiments, the profile the cavity is essentially a slightly larger version of the outer profile of the magnet in the cavity. That is, if the magnet is a disk shaped magnet, the interior of the cavity will be negatively disk shaped. Thus, for textual economy, the various dimensions detailed above with respect to the magnet can correspond to the dimensions of the cavity, save for the maximum dimensions of the magnet (and for those, the dimensions of the cavity can be plussed up from those by 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% or any value or range of those therebetween in 0.1% increments—indeed, this can be the case for all of the dimensions disclosed for the magnet).
With respect to the magnet and the plates in the cavity, there is an upper surface and a lower surface that is normal to the longitudinal axis of those components. For example, the upper surface of the cavity can be formed by the housing wall at the top, and the lower surface of the cavity can be formed by the housing wall at the bottom. These are the major surfaces of the cavity, and corresponding/facing surfaces of the shim and the magnet are also the major surfaces, at least when the magnet is a disk. The major surfaces have feature that have certain geometric values. For example, all or at least 90, 95 or 99% of the surfaces can be within two parallel planes that are 25 microns from each other, or 10 or 20, or 30, or 40, 50, 60, 70, 80, 90, 100, 125, 150, 175 or 200 microns from each other. Also, the top and bottom surfaces are parallel to each other within any of those values when taken at the outermost portions of the surfaces. Also as can be seen, with respect to the longitudinal axes, no part of the shim overlaps any part of the magnet. This is also the case with respect to the lateral axes. Also as can be seen, at least one of the major surfaces the shim are parallel to at least one of the major surfaces of the magnet (or both can be parallel) when the magnet is at its closest position relative to the shim. This is opposed to an arrangement where the magnet where the shim has a curved surface. In an exemplary embodiment, when the magnet in shim or at their closest approach, the aforementioned parallel features are present (e.g., one end of the bottom surface of the magnet has a distance to the closest portion of the shim, and another end of the bottom surface of the magnet furthest from the one and has a distance to the closest portion of the shim, and those two distances do not have a difference greater than the various values detailed above with respect to the parallel planes (this is geometric dimensioning and tolerancing).
While the embodiments described above all have a shim that does not overlap with the magnet in the lateral direction, other embodiments of the shim that does overlap in the longitudinal direction. By way of example only and not by way of limitation,
In the embodiments described above with respect to the laterally positioned magnetic components, the magnetic attraction is such that the magnet is pulled to one side or otherwise is pulled in the lateral direction (and thus downward or upward or forward or backward, depending on the orientation of implantation when the human is standing erect) as opposed to the longitudinal direction (and thus to the side when the human is standing erect). That is, instead of a major surface being held against a major surface of the shim were a major surface of the cavity, a lateral surface, or more accurately, a portion of a lateral surface is held against a portion of a lateral surface of the cavity or the magnetic component or both. It is noted that while in some embodiments, the magnetic components, or more specifically, the center of masses of the magnetic components, are positioned equidistant with respect to the top and bottom of the cavity, while in other embodiments, the magnetic component, or more accurately, the center of mass of the magnetic component opposition an offset manner relative to the center of the cavity. This can have the effect of pulling the magnet in the lateral direction while also pulling the magnet in the longitudinal direction (or, more accurately, the magnet pulling itself in those directions).
As noted above,
In an embodiment, lateral movement of the magnet is restricted, either by friction as noted above, or by laterally spaced magnetic shims (or both). For example, in an embodiment, when implanted, the magnet does not move up and down (or down and up) in the case of a bottom mounted shim (or top mounted ship—with respect to the direction of gravity) and/or forward or backward (or backward of forward) in the case of a backward/rearward located (or forward/frontward located) shim (or magnetic material). In an embodiment, the magnet can “rock” within the housing. For example, if the shim is located at the bottom of the housing, and the cavity in which the magnet is located is circular, and the magnet is circular, and the diameter of the cavity is larger than the diameter of the magnet in the lateral direction (the housing has a greater radius of curvature than the magnet), the magnet can rock in the housing while being held against the wall. For example, the magnet could move upward and forward by “rolling” along the housing wall, and could roll back, thus rolling backwards and downward and then upward (while still rolling backwards). The magnetic attraction may permit this movement, albeit the movement might be more limited than that which would otherwise be the case without the shim.
And it reiterated that the embodiments where the magnetic material is located at longitudinal locations relative to the magnet (and thus between the skull and the magnet or between the outer surface of the skin and the magnet), the above movements and restrictions of movement can also be applicable, with or without the shim that is located at lateral sides. In an embodiment, the friction force between the major surfaces of the magnet and the housing (or a component attached to the housing/a component of the housing assembly) is sufficiently strong that the magnet will not move laterally under certain accelerations, such as any one or more of those detailed herein, in the vertical direction/the direction of gravity. Conversely, such embodiments can also still permit the magnet to rotate for alignment with the external component when the external component is placed in proximity to the implanted magnet/placed against the skin. Moreover, the lateral movement can exist, even if the magnet does not become separated from the housing or a component of the housing assembly. That is, the entire magnet can slide laterally along the surface of the housing/housing assembly, for alignment with the external component magnet. The magnet can slide and rotate as well. Embodiments can include balancing the force adhering the magnet to the housing assembly with the utilitarian desires for the magnet to be able to rotate for alignment purposes with the external magnet. That said, embodiments include an arrangement where the magnet does not rotate for alignment purposes in some other embodiments (at least for some scenarios where the external magnet is misaligned by a certain amount) when the external component is magnetically coupled to the implantable portion, but will rotate when exposed to an MRI magnetic field of 1.5, 2, 2.5, 3, 3.5 or 4 T or more at a specific angle that will cause rotation.
At least some exemplary embodiments take into account the management of the magnetic flux created by the magnet. For example, segmented plates and/or plates of different patterns, such as those of
With regard to retention, it can be that in at least some embodiments, by placing the magnetic material on the skull facing side, retention of the external component is increased/is greater than that which would be the case if the magnetic material were on the skin facing side. That is, there could be a disadvantage to placing the material on the skin facing side as such might reduce retention force of the external device due to magnetic flux shunting, which can be problematic at least for recipients with high skin flap thicknesses. Conversely, placing the ferromagnetic/magnetic material on the skull side can have less of a reduction effect on retention (because it may shunt less of the magnetic flux from coupling to the external magnet). Accordingly, in an exemplary embodiment, all things being equal, for a spacing of the implant magnet and the external magnetic of the same distance, a retention force of the external magnet to the implant magnet when the implant magnet is in the magnet apparatus is 1.05, 1.1, 1.15, 1.2, 1.25, 1.3, 1.35, 1.4, 1.45 or 1.5 or more or any value or range of values therebetween in 0.01 increments greater for the same shim located on the skull facing side than for the same shim located on the skin facing side (between the two magnets). Moreover, putting the ferromagnetic/magnetic material around the periphery has the advantage of having less effect on retention.
And the embodiments that have the magnetic material at the lateral location(s) also can have utilitarian value with respect to avoiding/minimizing/reducing cogging. And these too can be tuned to achieve such.
The utilization of different size magnetic material bodies and/or a different distribution of material between the central axis of the implanted magnet and the periphery of the implant magnet can be used to tune for the amount of torque needed to rotate the magnet. For example, a central dot vs. around ring could both provide similar amounts of attraction, but it may be easier for the magnet to rotate with the central dot design, making it easier for external SP alignment. Accordingly, embodiments include a tuned magnetic material arrangement that optimizes two or more of rotatability, antirattle and external component retention.
It is again noted that while the phrase shim has been utilized herein quite frequently, embodiments are not so limited. Any disclosure of a shim herein corresponds to a disclosure of a component that has flat parallel major surfaces.
In an embodiment, there is no viscous damping fluid and/or damping material in the housing. Indeed, the fluid is a low viscosity fluid if present, so as to enhance the rotation of the magnet.
Any disclosure of a device and/or system detailed herein also corresponds to a disclosure of otherwise providing that device and/or system and/or utilizing that device and/or system.
Any disclosure of an embodiment that has a functionally corresponds to a device configured to have that functionality, and also corresponds to a method that results in the functionality/includes the actions associated with the functionality, and vice versa.
Any embodiment or any feature disclosed herein can be combined with any one or more or other embodiments and/or other features disclosed herein, unless explicitly indicated and/or unless the art does not enable such. Any embodiment or any feature disclosed herein can be explicitly excluded from use with any one or more other embodiments and/or other features disclosed herein, unless explicitly indicated that such is combined and/or unless the art does not enable such exclusion.
Any function or method action detailed herein corresponds to a disclosure of doing so an automated or semi-automated manner.
Any disclosure herein of any component and/or feature can be combined with any one or more of any other component and/or feature disclosure herein unless otherwise noted. Providing that the art enables such. Any disclosure herein of any component and/or feature can be explicitly excluded from combination with any one or more or any other component and/or feature disclosed herein unless otherwise noted, providing that the art enables such. Any disclosure herein of any method action includes a disclosure of a device and/or system configured to implement that method action. Any disclosure herein of a device and/or system corresponds to a disclosure of a method of utilizing that device and/or system. Any disclosure herein of a manufacturing method corresponds to a disclosure of a device and/or system that results from the manufacturing method. Any disclosure of a device and/or system corresponds to a disclosure of a method of making a device and/or system.
While various embodiments of the present invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention.
This application claims priority to U.S. Provisional Application No. 63/291,682, entitled ADVANCED RETENTION MAGNET SYSTEM FOR MEDICAL DEVICE, filed on Dec. 20, 2021, naming Wilson FUNG as an inventor. This application also claims priority to U.S. Provisional Application No. 63/433,794, entitled MORE ADVANCED RETENTION MAGNET SYSTEM FOR MEDICAL DEVICE, filed on Dec. 20, 2022, naming Charles Roger Aaron LEIGH as an inventor. The entire contents of each application being incorporated herein by reference in their entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2022/062541 | 12/20/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63433794 | Dec 2022 | US | |
| 63291682 | Dec 2021 | US |
