Hearing loss, which may be due to many different causes, is generally of two types: conductive and sensorineural. Sensorineural hearing loss is due to the absence or destruction of the hair cells in the cochlea that transduce sound signals into nerve impulses. Various hearing prostheses are commercially available to provide individuals suffering from sensorineural hearing loss with the ability to perceive sound. For example, cochlear implants use an electrode array implanted in the cochlea of a recipient to bypass the mechanisms of the ear. More specifically, an electrical stimulus is provided via the electrode array to the auditory nerve, thereby causing a hearing percept.
Conductive hearing loss occurs when the normal mechanical pathways that provide sound to hair cells in the cochlea are impeded, for example, by damage to the ossicular chain or the ear canal. Individuals suffering from conductive hearing loss may retain some form of residual hearing because the hair cells in the cochlea may remain undamaged.
Individuals suffering from conductive hearing loss typically receive an acoustic hearing aid. Hearing aids rely on principles of air conduction to transmit acoustic signals to the cochlea. In particular, a hearing aid typically uses an arrangement positioned in the recipient's ear canal or on the outer ear to amplify a sound received by the outer ear of the recipient. This amplified sound reaches the cochlea causing motion of the perilymph and stimulation of the auditory nerve.
In contrast to hearing aids, which rely primarily on the principles of air conduction, certain types of hearing prostheses commonly referred to as bone conduction devices, convert a received sound into vibrations. The vibrations are transferred through the skull to the cochlea causing generation of nerve impulses, which result in the perception of the received sound. Bone conduction devices are suitable to treat a variety of types of hearing loss and may be suitable for individuals who cannot derive sufficient benefit from acoustic hearing aids, cochlear implants, etc, or for individuals who suffer from stuttering problems.
In accordance with one aspect, there is a device, comprising a transducer, and a connection assembly in fixed relationship with the transducer, configured to transfer vibrational energy directly or indirectly, at least one of to or from, the transducer, wherein a first component of the connection assembly is actively held by positive retention to the device by a second component of the connection assembly.
In accordance with another aspect, there is a device, comprising a transducer, and a housing encompassing at least a portion of the transducer, wherein the device includes a rotation limiter that limits rotation of the housing relative to the transducer.
In accordance with another aspect, there is a device, comprising a removable component of a bone conduction device, including a connector apparatus configured to removably connect the removable component to a recipient skin penetrating component, wherein the removable component of the bone conduction device does not include any metallic components within at least about 3 mm from a longitudinal end of the removable component on the connector side thereof.
In accordance with another embodiment, there is a device, comprising a removable component of a bone conduction device, including a connector configured to removably connect the removable component to a metallic skin penetrating component, wherein the removable component is configured such that when the connector is operationally coupled to the metallic skin penetrating component when the connector is grounded and a potential difference between the connector and the skin penetrating component 0.1 seconds prior to the connector contacting the skin penetrating component is 10,000 volts, this potential difference is substantially maintained, in the absence of any change in the grounding state of the metallic skin penetrating component, for at least 0.1 seconds after the connector is operationally coupled to the skin penetrating component.
In accordance with another aspect, there is a device, comprising a removable component of a bone conduction device, including a connector configured to removably connect the removable component to a metallic skin penetrating component, wherein the removable component is configured such that when the connector is operationally coupled to the metallic skin penetrating component when one of the skin penetrating component and the connector is grounded and the other of the skin penetrating component and the connector has a charged capacitance of 100 picofarads, and a potential difference between the connector and the skin penetrating component is 10,000 volts, a total energy flow to the grounded component is no more than 50 millijoules per second.
In accordance with another aspect, there is a device as detailed above an/or below, wherein the removable component is configured such that when the connector is operationally coupled to the metallic skin penetrating component when one of the skin penetrating component and the connector is grounded and the other of the skin penetrating component and the connector has a charged capacitance of 100 picofarads, and a potential difference between the connector and the skin penetrating component is 10,000 volts, a total energy flow to the grounded component is no more than 50 millijoules per microsecond.
In accordance with another aspect, there is a device as detailed above an/or below, wherein the removable component is configured such that when the connector is operationally coupled to the metallic skin penetrating component when one of the skin penetrating component and the connector is grounded and the other of the skin penetrating component and the connector has a charged capacitance of 100 picofarads, and a potential difference between the connector and the skin penetrating component is 10,000 volts, a total energy flow to the grounded component is no more than 50 millijoules per millisecond.
In accordance with another aspect, there is a device as detailed above and/or below, wherein the removable component is configured such that when the connector is operationally coupled to the metallic skin penetrating component when the connector is grounded and a potential difference between the connector and the skin penetrating component 0.1 seconds prior to the connector contacting the skin penetrating component is 10,000 volts, this potential difference will be substantially maintained, in the absence of any change in the grounding state of the metallic skin penetrating component, for at least 1.0 seconds after the connector is operationally coupled to the skin penetrating component.
Some embodiments are described below with reference to the attached drawings, in which:
In a fully functional human hearing anatomy, outer ear 101 comprises an auricle 105 and an ear canal 106. A sound wave or acoustic pressure 107 is collected by auricle 105 and channeled into and through ear canal 106. Disposed across the distal end of ear canal 106 is a tympanic membrane 104 which vibrates in response to acoustic wave 107. This vibration is coupled to oval window or fenestra ovalis 210 through three bones of middle ear 102, collectively referred to as the ossicles 111 and comprising the malleus 112, the incus 113 and the stapes 114. The ossicles 111 of middle ear 102 serve to filter and amplify acoustic wave 107, causing oval window 210 to vibrate. Such vibration sets up waves of fluid motion within cochlea 139. Such fluid motion, in turn, activates hair cells (not shown) that line the inside of cochlea 139. Activation of the hair cells causes appropriate nerve impulses to be transferred through the spiral ganglion cells and auditory nerve 116 to the brain (not shown), where they are perceived as sound.
In an exemplary embodiment, bone conduction device 100A comprises an operationally removable component and a bone conduction implant. The operationally removable component is operationally releasably coupled to the bone conduction implant. By operationally releasably coupled, it is meant that it is releasable in such a manner that the recipient can relatively easily attach and remove the operationally removable component during normal use of the bone conduction device 100A. Such releasable coupling is accomplished via a coupling assembly of the operationally removable component and a corresponding mating apparatus of the bone conduction implant, as will be detailed below. This as contrasted with how the bone conduction implant is attached to the skull, as will also be detailed below. The operationally removable component includes a sound processor (not shown), a vibrating electromagnetic actuator and/or a vibrating piezoelectric actuator and/or other type of actuator (not shown—which are sometimes referred to herein as a species of the genus vibrator) and/or various other operational components, such as sound input device 126A. In this regard, the operationally removable component is sometimes referred to herein as a vibrator unit. More particularly, sound input device 126A (e.g., a microphone) converts received sound signals into electrical signals. These electrical signals are processed by the sound processor. The sound processor generates control signals which cause the actuator to vibrate. In other words, the actuator converts the electrical signals into mechanical motion to impart vibrations to the recipient's skull.
As illustrated, the operationally removable component of the bone conduction device 100A further includes a coupling assembly 240 configured to operationally removably attach the operationally removable component to a bone conduction implant (also referred to as an anchor system and/or a fixation system) which is implanted in the recipient. In the embodiment of
It is noted that while many of the details of the embodiments presented herein are described with respect to a percutaneous bone conduction device, some or all of the teachings disclosed herein may be utilized in transcutaneous bone conduction devices and/or other devices that utilize a vibrating electromagnetic actuator. For example, embodiments include active transcutaneous bone conduction systems utilizing the electromagnetic actuators disclosed herein and variations thereof where at least one active component (e.g. the electromagnetic actuator) is implanted beneath the skin. Embodiments also include passive transcutaneous bone conduction systems utilizing the electromagnetic actuators disclosed herein and variations thereof where no active component (e.g., the electromagnetic actuator) is implanted beneath the skin (it is instead located in an external device), and the implantable part is, for instance a magnetic pressure plate. Some embodiments of the passive transcutaneous bone conduction systems are configured for use where the vibrator (located in an external device) containing the electromagnetic actuator is held in place by pressing the vibrator against the skin of the recipient. In an exemplary embodiment, an implantable holding assembly is implanted in the recipient that is configured to press the bone conduction device against the skin of the recipient. In other embodiments, the vibrator is held against the skin via a magnetic coupling (magnetic material and/or magnets being implanted in the recipient and the vibrator having a magnet and/or magnetic material to complete the magnetic circuit, thereby coupling the vibrator to the recipient).
More specifically,
Bone conduction device 100B comprises a sound processor (not shown), an actuator (also not shown) and/or various other operational components. In operation, sound input device 126B converts received sounds into electrical signals. These electrical signals are utilized by the sound processor to generate control signals that cause the actuator to vibrate. In other words, the actuator converts the electrical signals into mechanical vibrations for delivery to the recipient's skull.
In accordance with some embodiments, a fixation system 162 may be used to secure implantable component 150 to skull 136. As described below, fixation system 162 may be a bone screw fixed to skull 136, and also attached to implantable component 150.
In one arrangement of
In another arrangement of
In an exemplary embodiment, the vibrating electromagnetic actuator 342 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 300 provides these electrical signals to vibrating electromagnetic actuator 342, or to a sound processor (not shown) that processes the electrical signals, and then provides those processed signals to vibrating electromagnetic actuator 342. The vibrating electromagnetic actuator 342 converts the electrical signals (processed or unprocessed) into vibrations. Because vibrating electromagnetic actuator 342 is mechanically coupled to plate 346, the vibrations are transferred from the vibrating electromagnetic actuator 342 to plate 346. Implanted plate assembly 352 is part of the implantable component 350, and is made of a ferromagnetic material that may 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 device 340 and the implantable component 350 sufficient to hold the external device 340 against the skin of the recipient. Accordingly, vibrations produced by the vibrating electromagnetic actuator 342 of the external device 340 are transferred from plate 346 across the skin to plate 355 of plate assembly 352. This can be accomplished as a result of mechanical conduction of the vibrations through the skin, resulting from the external device 340 being in direct contact with the skin and/or from the magnetic field between the two plates. These vibrations are transferred without penetrating the skin with a solid object such as an abutment as detailed herein with respect to a percutaneous bone conduction device.
As may be seen, the implanted plate assembly 352 is substantially rigidly attached to a bone fixture 341 in this embodiment. Plate screw 356 is used to secure plate assembly 352 to bone fixture 341. The portions of plate screw 356 that interface with the bone fixture 341 substantially correspond to an abutment screw discussed in some additional detail below, thus permitting plate screw 356 to readily fit into an existing bone fixture used in a percutaneous bone conduction device. In an exemplary embodiment, plate screw 356 is configured so that the same tools and procedures that are used to install and/or remove an abutment screw (described below) from bone fixture 341 can be used to install and/or remove plate screw 356 from the bone fixture 341 (and thus the plate assembly 352).
It is noted that with respect to the embodiments of
As will be further detailed below, various teachings detailed herein and/or variations thereof can be applicable to the various embodiments of
Some exemplary features of the vibrating electromagnetic actuator usable in some embodiments of the bone conduction devices detailed herein and/or variations thereof will now be described in terms of an operationally removable component of the bone conduction device used in the context of the percutaneous bone conduction device of
Also shown in
As illustrated in
In an exemplary embodiment, an embryonic rivet has one or both ends that is/are straight (not flared). During assembly, the rivet is fit through all of the pertinent holes of the electromagnetic transducer 450, and fit through the hole in the extension assembly 459 (at the top), and a flaring mandrel is used to flare the rivet to the configuration depicted in
It is noted that unless otherwise specified, the electromagnetic transducers detailed herein are radially symmetrical.
Counterweight assembly 455 includes springs 456 and 457, permanent magnets 458A and 458B, yokes 460A, 460B and 460C, spacers 462, and counterweight mass 470. Spacers 462 provide a connective support between spring 456 and the other elements of counterweight assembly 455 just detailed, although it is noted that in some embodiments, these spacers are not present, and the spring is connected only to the counterweight mass 470, while in other embodiments, the spring is only connected to the spacers. Springs 456 and 457 connect bobbin assembly 454 via spacers 422 and 424 to the rest of counterweight assembly 455, and permit counterweight assembly 455 to move relative to bobbin assembly 554 upon interaction of a dynamic magnetic flux, produced by coil 454B. The static magnetic flux is produced by permanent magnets 458A and 458B of counterweight assembly 455. In this regard, counterweight assembly 455 is a static magnetic field generator, where the permanent magnets 458A and 458B are arranged such that their respective south poles face each other and their respective north poles face away from each other. It is noted that in other embodiments, the respective south poles may face away from each other and the respective north poles may face each other.
Coil 454B, in particular, may be energized with an alternating current to create the dynamic magnetic flux about coil 454B. In an exemplary embodiment, bobbin 454A is made of a soft iron. The iron of bobbin 454A is conducive to the establishment of a magnetic conduction path for the dynamic magnetic flux. In an exemplary embodiment, the yokes of the counterweight assembly 455 are made of soft iron also conducive to the establishment of a magnetic conduction path for the static magnetic flux.
It is noted that the electromagnetic actuator of
It is further noted that in alternative embodiments, the teachings detailed herein and/or variations thereof can be applicable to unbalanced electromagnetic actuators, at least with respect to a bobbin thereof through which a dynamic magnetic flux passes.
As can be seen from
Still with reference to
Still with reference to
The embodiment of
Referring now to
As noted above, embodiments can be practiced that include additional elements that are not depicted in
Still with reference to
Wall 574 includes an inside surface 574I and an outside surface 574O. In an exemplary embodiment, at least a part of the inside surface 574I forms a cylindrical surface that is threaded to receive a corresponding outer cylindrical surface 594O of fastener 590, at least a portion of surface 594O also being threaded. Conversely, outside surface 574O includes one or more substantially non-uniform surfaces relative to one another. By way of example only and not by way of limitation, outside surface 574O can include one or more planar surfaces, one or more surfaces having a different radius of curvature from that of one or more other services, etc. That said, it is noted that in an alternative embodiment, surface 574O can be cylindrical, at least when additional features are present as will be detailed below. In this regard, any surface that will enable surface 574O to interface with inner surface 584I of stop apparatus 580 such that the teachings detailed herein and/or variations thereof can be practice can be utilized in at least some embodiments. One of these teachings is that the geometries of the surfaces 574O and 584I are such that relative rotation between the interface adapter 570 and the stop apparatus 580 is effectively prevented (which includes totally prevented). In this regard, the respective surfaces form a locking relationship with respect to rotation about longitudinal axis 601 (which is concentrically aligned with longitudinal axis 401 of
Along these lines, in at least some embodiments, surface 584I has a surface that is at least effectively opposite that of 574O, and configured to receive surface 574O therein in a male-female relationship. By way of example only and not by way of limitation, if, in totality, outside surface 574O has, for example a square shape, a hexagon shape and/or an octagon shape with respect to a cross-section of interface adapter 570 lying on a plane normal to the longitudinal axis 601 and passing through wall 574, inside surface 584I has, for example, a square shape, a hexagon shape, and/or an octagon shape, respectively, with respect to the aforementioned plane (that also passes through wall 584 of stop apparatus 580). Note further that in at least some embodiments, the shapes do not necessarily correspond to one another. By way of example, with respect to the embodiment where surface 574O has an octagon shape with respect to the aforementioned plane, surface 584I can have a square shape with respect to the aforementioned plane and still effectively prevent relative rotation between the interface adapter 570 and the stop apparatus 580. This is because a properly sized octagon can fit into a properly sized square and prevent rotation albeit there might be less surface to surface contact than that which would be the case if surface 584 I was also an octagon. In some embodiments, the shapes are the same.
It is noted at this time that while the embodiments depicted herein depict interface adapter 570 in a male relationship with respect to stop apparatus 580, which is in a female relationship with respect to interface adapter 570, in alternative embodiments, the opposite can be the case.
As noted above, surface 574O and surface 584 I can be cylindrical. In such embodiments a key can be utilized to prevent rotation between the pertinent components. By way of example only and not by way of limitation, a dowel pin can be inserted through a hole in stop apparatus 580 and through a hole in wall 574 of interface adapter 570. This dowel pin can be aligned normally with respect to the longitudinal axis 601. Alternatively and/or in addition to this, a key can be inserted in a hole that is made up in part by wall 584 and wall 574. Such a key can be a dowel pin that is inserted in this hole that is parallel to the longitudinal axis 601. Because a portion of this key (dowel pin) interfaces with wall 574 and a portion of this key (dowel pin) interfaces with wall 584, relative rotation between the interface apparatus 570 and the stop apparatus 580 is effectively prevented. Any device, system and/or method that can be utilized to effectively prevent relative rotation between the interface adapter 570 and the stop apparatus 580 can be utilized in at least some embodiments.
There is utilitarian value in preventing relative rotation between the interface adapter 570 and the stop apparatus 580 in at least some embodiments because stop apparatus 580 and housing 442 to collectively form a rotation limiter. Referring now to
The housing 542 and the stop apparatus 580 are dimensioned and configured such that there is a space between these components that enables the components to not contact one another during normal operation and use of the removable component of the bone conduction device 400. That is, in an exemplary embodiment, referring back to the removable component of bone conduction device 200 of
Stop apparatus 580 and housing 542 are dimensioned and configured such that upon a sufficient rotation of one component about longitudinal axis 401 relative to the other component, the components will contact each other, thereby preventing further rotation. This contact occurs prior to the rotation that would result in plastic deformation of the spring or an otherwise deleterious deformation of the spring. Thus, this exemplary embodiment includes a rotation limiter that is configured to limit rotation of the housing 542 relative to the transducer of the removable component of the bone conduction device 400 relative to that which would be the case in the absence of the rotation limiter. Again, in an exemplary embodiment, this has utility in that this prevents the spring 244 from being plastically deformed or otherwise altered such that the bone conduction device might not perform according to the teachings detailed herein and or variations thereof. In this regard, referring now to
Thus, the bone conduction device 400 includes a rotation limiter that comprises or more components 580F in fixed relationship to the transducer 450 and one or more components 542M in fixed relationship to the housing 542 that are configured to rotationally move relative to one another until contact between the respective components, thereby limiting the relative rotation of the housing 542 and the transducer 510. Because of the mating relationship between the components 542M and the 580F, female component 580F defines the extent to which relative rotation of the housing 542 occurs as a result of limiting the movement of the male component 542M therein. Further, bone conduction device includes an apparatus extending from the transducer 410, extension assembly 449, which also extends away from the housing 542, configured to transfer vibrational energy directly or indirectly, at least one of to or from, the transducer 410, wherein there are one or more components 580F (or, in an alternate embodiment, 542M) in fixed relationship to the transducer 410 which are in fixed relationship to the apparatus (extension assembly 449) extending from the transducer 410.
It is noted that the angles A1 and A2 need not be the same. That is, in some embodiments, the rotation limiter of the bone conduction device can be such that the housing can be rotated more in one direction than the other direction. It is further noted that in at least some embodiments, the housing 542 and/or the stop apparatus 580 is dimensioned and configured such that the expected/anticipated movements relative to one another in the longitudinal direction of axis 401 are such that there is always overlap between housing 442/542 and stop apparatus 580 such that rotations between the two corresponding to angles A1 and/or A2 always results in contact between the sidewalls of the female receptacle 580F and the male protrusions 542M, and thus the rotation as always limited to the aforementioned angles.
In alternative embodiments, the configurations can be different than those detailed in the figures. By way of example only and not by way of limitation, the housing 542 can include female recesses, and the stop apparatus 580 can include the male protrusions, and/or both can include one or more male protrusions and/or one or more female recesses. In this regard, it is noted that while the embodiments of the figures are depicted as having two male protrusions and two female recesses, in alternate embodiments there can be more or fewer recesses and protrusions. Also, it is noted that while the male protrusions 542M are depicted as being an integral component of the housing 542, in an alternate embodiment, these projections can be a separate component from the remainder of the housing 542, such as along the lines with the stop apparatus 580 which is a separate component from the remainder of the extension assembly 559. Indeed, in an exemplary embodiment, the bottom portion of the housing 542 is mechanically coupled to the remaining portions of the housing 542 (e.g. by threading, snap fit etc.). In this regard, the bottom portion of the housing 442 containing the stop components (protrusions 542M or recesses in alternative embodiments) can be a lid-like component that closes the remaining cylinder of the housing 442/542. In an exemplary embodiment, the protrusions 542M (or recesses in alternate embodiments) can be monolithic components of at least a substantial portion of the housing 542 (e.g., such as in the embodiment where the components are part of a lid like component). Any device, system, and/or method that can enable rotation between the housing 442/542 and the extension assembly 559 can be utilized in at least some embodiments.
Referring again to
That said, as can be seen in the embodiment of
Still with reference to
In an exemplary embodiment, at least a part of the inside surface 5961 forms a cylindrical surface that is threaded to receive a corresponding outer cylindrical surface 546O of sleeve 544 (see
Along these lines, in at least some embodiments, surface 541I has a surface that is at least effectively opposite that of 596O. By way of example only and not by way of limitation, if, in totality, outside surface 596O has, for example a square shape, a hexagon shape and/or an octagon shape with respect to a cross-section of fastener 590 lying on a plane normal to the longitudinal axis 601 and passing through lower body 596, inside surface 541I has, for example, a square shape, a hexagon shape, and/or an octagon shape, respectively, with respect to the aforementioned plane (that also passes through section 543 of coupling 541). Note further that in at least some embodiments, the shapes do not necessarily correspond to one another. In this regard, reference is made to the teachings above with respect to the interface adapter 570/stop apparatus 580 mating surfaces. It is noted that in some embodiments, the surfaces can have the same shape.
It is noted at while the embodiments depicted herein depict fastener 590 in a male relationship with respect coupling 541 (and thus a portion of the protective sleeve—the portion that forms surface 546O—is located within the passage from the space inside the transducer 550 to the sleeve 544), which is in a female relationship with respect to fastener 590, in alternative embodiments, the opposite can be the case.
As noted above, surface 596O and surface 541 I can be cylindrical. In such embodiments a key can be utilized to prevent rotation between the pertinent components. By way of example only and not by way of limitation, the concepts detailed above with respect to utilization of the dowel pin or the like to prevent relative rotation of the stop apparatus 580 relative to interface adapter 570 can be utilized.
It is noted in an at least some embodiments, coupling 541 is slip fit onto fastener 590. That is, in the absence of positive retention of coupling 541 to fastener 590, coupling 541 easily slides off the fastener 590.
That said, as can be seen in the embodiments of
Accordingly, in an exemplary embodiment, there is a bone conduction device according to any of the teachings detailed herein and/or variations thereof that includes a transducer such as the electromagnetic transducer 410 of the embodiments of
By way of example only and not by way of limitation, the connection assembly can include the coupling 441 and sleeve 444 of the embodiments of
In an exemplary embodiment, a component of the connection assembly, such as by way of example the coupling 441, is actively held by positive retention to the bone conduction device by another component of the connection assembly, such as by way of example the sleeve 444. By “actively held by positive retention,” it is meant that the other component of the connection assembly provides the retention of the component to the device such that in the absence of that another component, the component would not be positively retained to the bone conduction device. By way of example only and not by way of limitation, if the coupling 441 is slip fit onto the faster 490, the sleeve 444 actively holds the coupling 441 to the bone conduction device by positive retention. Conversely by way of example only and not by way of limitation, if the coupling 441 is threaded to the faster 490 and/or otherwise interference fitted to the faster 490 such that the bone conduction device could be effectively utilized to evoke a hearing percept without positive retention by another device (e.g. the sleeve 444), there would be no active holding by positive retention by the coupling 441 because the coupling 441 holds itself to the bone conduction device and permits the bone conduction device to effectively evoke a hearing percept. Put another way, if the coupling 441 can be held to the bone conduction device in the absence of the sleeve 444, and the bone conduction device can effectively be used to evoke a hearing percept, and there is no other component that provides positive retention to the coupling 441, there is no active holding by positive retention of the coupling 441 by second device, even though the coupling 441 is indeed held by positive retention (the threads, but the threads but this is done by the coupling 441 itself).
In some embodiments, sleeve 444/549 includes a screw driver receptacle (flat or Phillips or other type) or a wrench receptacle (e.g., Allen wrench). In an exemplary embodiment, with reference to
In an embodiment, the coupling 441 is a component that wears during the use of the bone conduction device over a period of time. By way of example only and not by way of limitation, a bone conduction device can be used, albeit intermittently, over a period of 1, 2, 3, 4 or 5 or more years. In at least some exemplary scenarios, the bone conduction device will be attached the recipient via the abutment 620 (with reference to
Accordingly, in an exemplary embodiment, the coupling 441 is a replaceable/removable component from the remainder of the bone conduction device. In an exemplary embodiment, there is utilitarian value in constructing the bone conduction device such that the coupling 441/541 is relatively easy to remove and a new coupling 441/541 is relatively easy to install onto the removable component of the bone conduction device. Indeed, in an exemplary embodiment, the coupling 541 can be removed from the rest of a fully operational removable component of a bone conduction device in a configuration for use for normal every day evoking of a hearing precept (normal operation) without removing any other components except those components that positively retained the coupling 441/541 to the remainder of the bone conduction device. That is, with respect to the embodiments of
That is, in an exemplary embodiment, the coupling 441 can be removed from the faster 490 with the fastener 490 attached to the interface adapter 470 and/or the stop apparatus 480 while the interface adapter 470 and/or stop apparatus 480 is in fixed relationship to the electromagnetic transducer and is in mechanical coupling relationship with the housing 442.
Further, sleeve 444 is an item that can be subject to wear and/or structural fatigue and or fracture (e.g., if the sleeve 444, which can be made out of plastic, is pressed too hard against the abutment wall, which is typically made of titanium or another metal). Accordingly, in some embodiments, it is utilitarian to be able to remove the sleeve 444 from the rest of the removable component of the bone conduction device and replace the sleeve 444 with a new sleeve (in an exemplary embodiment, this is the case without removing, for example, coupling 441). Of course, in an alternative embodiment, the sleeve 444 may not “need” to be replaced (e.g., the condition thereof is still functional), but its removal is utilitarian in that it permits access to another component and/or permits another component, such as the coupling 441, to be removed, or otherwise more easily removed, as compared to removal of that component without removal of the sleeve. In some embodiments, it is utilitarian to be able to replace the sleeve 444 without disassembling and/or significantly disassembling the bone conduction device. For example, in an exemplary embodiment, it is utilitarian to only remove the sleeve 444 from the rest of the bone conduction device.
In an exemplary embodiment, the abutment is a generally concave component having a hollow portion at a top thereof into which the coupling assembly 440 fits (with reference to
It is noted that while the embodiment of the coupling assembly 440 detailed herein is directed to a snap-fit arrangement, in an alternate embodiment, a magnetic coupling can be used. Alternatively, a screw fitting can be used. In some embodiments, the coupling assembly 440 corresponds to a female component and the abutment corresponds to a male component, in some alternate embodiments, this is reversed. Any device, system or method that can enable coupling of the removable component to an implanted prosthesis can be utilized in at least some embodiments providing that the teachings detailed herein and/or variations thereof can be practiced.
As noted above, any removable component of the bone conduction device 400 includes a protective sleeve 444 that is part of the coupling assembly 440. In this regard, coupling 441 is a male portion of a snap coupling that fits into the female portion of abutment 620, as can be seen in
Referring to
With reference to
As noted above, in an exemplary embodiment, the removable component of the bone conduction device 400 is configured such that access to the sleeve 444 can be obtained through the space 454D in bobbin 554A. Referring back to
With respect to the embodiments of
In this regard, an outer diameter of the sleeve 444 (the outer diameter of surface 4460 that fits in the hollow portion of the bobbin extension 454A is larger, at a given temperature, then the interior interfacing diameter of that hollow portion at that same temperature. In an exemplary embodiment, the attachment depicted in
It is noted that while the embodiment of
While the embodiments detailed herein up to this point have tended to focus on percutaneous bone conduction devices, variations of these embodiments are applicable to passive transcutaneous bone conduction devices. In this regard, the fixation regimes and methods described herein and/or variations thereof are applicable to fixation of an electromagnetic transducer to a pressure plate of a passive transcutaneous bone conduction device, such as the plate 346 of
Plate 746 includes magnet 747, which corresponds to the magnet of external device 340 of
Some additional geometric features of some embodiments will now be described, which geometric features can have utilitarian value with respect to electrostatic discharge (detailed further below).
In an exemplary embodiment, there is a removable component of a bone conduction device, such as by way of example the removable components 400 of
In an exemplary embodiment, dimension D1 is 3 mm. In an alternative embodiment dimension D1 is 3 mm or more than 3 mm. In some alternate embodiments, dimension D1 is 2 millimeters or more than 2 mm. In an exemplary embodiment, dimension D1 is about 2.0 mm, 2.1 mm, 2.2 mm, 2.3 mm, 2.4 mm, 2.5 mm, 2.6 mm, 2.7 mm, 2.8 mm, 2.9 mm, 3.0 mm, 3.1 mm, 3.2 mm, 3.3 mm, 3.4 mm, 3.5 mm, 3.6 mm, 3.7 mm, 3.8 mm, 3.9 mm, 4.0 mm, 4.1 mm, 4.2 mm, 4.3 mm, 4.4 mm, 4.5 mm, 4.6 mm, 4.7 mm, 4.8 mm, 4.9 mm, 5.0 mm or more, or any value or range of values between any of these values in 0.05 mm increments (e.g., about 3.25 mm, about 2.85 mm to about 3.60 mm, etc.) Any distance that can enable the teachings detailed herein and/or variations thereof with respect to the electromagnetic discharge as discussed below can be utilized in at least some embodiments, etc.
Referring now to
In an exemplary embodiment, the aforementioned geometries related to the longitudinal end of the removable component of bone conduction device 400 can have utilitarian value in that there is improved resistance with respect to electrostatic discharge, at least with respect to such that can damage the components of the bone conduction device and or cause a sensation of pain or otherwise discomfort in the recipient during attachment/coupling of the removable component of the bone conduction device to the skin penetrating component. More particularly, in an exemplary embodiment, a human recipient might conceivably develop a static electric charge (e.g., by walking across a wool carpet without lifting his or her feet off the carpet in a room with a relative humidity of 25%). Alternatively, the removable component of the bone conduction device might develop such a charge. In an exemplary embodiment, a potential difference between the human and the removable component of the bone conduction device when the two are effectively separated from one another such that there is no electrical communication between the two can be on the order of about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 22, 25, 30, 35, 40, 45, 50 or about more than 50 thousand volts or any value or range of values therebetween in about 100 volt increments (e.g., about 4,400 volts, about 22,900 volts, about 2,500 to 30,500 volts, etc.). This, coupled with a sufficient buildup in charge in the human recipient and/or the removable component of the bone conduction device 400 can result, in at least some in instances, in the aforementioned deleterious results, at least at the instant when, or more accurately, just before, the removable component of the bone conduction device 400 is coupled to the skin penetrating abutment 620 of the recipient if there exists a low resistance conductive path in the removable component of the bone conduction device leading to, for example, the electromagnetic transducer, that comes into close enough proximity to the skin penetrating abutment. For example, consider the scenario where a metallic component of the removable component extended to within, for example, less than about ½ mm of the abutment screw 674, even with the plastic of the sleeve 444 therebetween, where the metallic component was electrically coupled to the remainder of the transducer in a low resistivity manner (e.g. electrically low resistivity coupled to the bobbin body 454A, etc.). If a sufficiently high potential difference exists between the removable component and the recipient, and at least one of the removable component of the bone conduction device and the human has a high enough charge, static electricity can arc between the abutment 620 and/or the abutment screw 674 and the metallic component (in some instances it can arc through the sleeve 444). The arcing static electricity can be of a magnitude such that one or more the deleterious results detailed herein can result.
In at least some embodiments of the embodiments detailed herein and/or variations thereof having at least some of the geometries detailed herein and/or variations thereof, the aforementioned deleterious results vis-à-vis static electricity are prevented from occurring, or at least the likelihood of such occurrences substantially reduced relative to that of the exemplary bone conduction device having the ½ mm gap between metallic components just detailed in the prior paragraph.
More particularly, in an exemplary embodiment, there is a removable component of the bone conduction device 400, including a connector (e.g., coupling apparatus 444) configured to removable connect the removable component to a metallic skin penetrating component, such as by way of example only and not by way of limitation, the abutment 620, with or without the abutment screw 674. The removable component is configured such that when the connector is operationally connected to the metallic skin penetrating component (and thus brought into electrical communicative proximity of the metallic skin penetrating component (abutment 620 and/or screw 674)) when the connector is grounded and a potential difference between the connector and the skin penetrating component T1 seconds prior to the is connector contacting the skin penetrating component is V volts, this potential difference will be substantially maintained, in the absence of any change in the grounding state of the recipient and/or the skin penetrating component, for at least T2 seconds after the connector is operationally coupled to the skin penetrating component (i.e., the configuration of
In various exemplary embodiments, at least about 95%, 90%, 85%, 80%, 75%, 70%, 65%, 60%, 55% or about 50% of the aforementioned potential differences are maintained during the aforementioned temporal periods. In an exemplary embodiment, T1 and/or T2 is about 1 second, about 1 microseconds, or about 1 millisecond. In an exemplary embodiment, T1 and/or T2 is about 100 nanoseconds, 200 ns, 300 ns, 400 ns, 500 ns, 600 ns, 700 ns, 800 ns, 900 ns, 1 μs, 10 μs, 50 μs, 100 μs, 200 μs, 300 μs, 400 μs, 500 μs, 600 μs, 700 μs, 800 μs, 900 μs, 1 ms, 10 ms, 100 milliseconds, 200 ms, 300 ms, 400 ms, 500 ms, 600 ms, 700 ms, 800 ms, 900 ms, 1 second, 2 seconds, three seconds, four seconds, five seconds or more or any value or range of values in between any of these values in 10 nanosecond increments (e.g., about 430 ns, about 10.05 microseconds, about 820 ns to about one-half second, etc.)
In an exemplary embodiment, V is about 0.5 thousand, 0.6, 0.7, 0.8, 0.9, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 22, 25, 30, 35, 40, 45, 50 thousand or about more than 50 thousand volts or any value or range of values therebetween in about 100 volt increments (e.g., about 4,400 volts, about 10,000 volts, about 22,900 volts, about 2,500 to 30,500 volts, etc.).
More particularly, in an exemplary embodiment, there is a removable component of the bone conduction device 400, including a connector (e.g., coupling apparatus 444) configured to removable connect the removable component to a metallic skin penetrating component, such as by way of example only and not by way of limitation, the abutment 620, with or without the abutment screw 674. The removable component is configured such that when the connector is operationally connected to the metallic skin penetrating component (and thus brought into electrical communicative proximity of the metallic skin penetrating component (abutment 620 and/or screw 674)) when one of the skin penetrating component and the connector is grounded and the other of the skin penetrating component and the connector has a charged capacitance of X picofarads, and a potential difference between the connector and the skin penetrating component is Y volts, a total energy flow to the grounded component is no more than Z millijoules per a given time period T, which configuration can be tested in a laboratory environment.
In an exemplary embodiment, X is about 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 210, 220, 230, 240, 250, 260, 270, 280, 280, 300, 325, 350, 375, 400, 425, 450, 475, 500, 525, 550, 575, 600 or more picofarads, or any value or range of values therebetween in 1 picofarad increment (e.g., about 111 picofarads, about 1000 picofarads, about 292 picofarads, about 77 to about 424 picofarads, etc.).
In an exemplary embodiment, Y is about 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 17, 19, 22, 25, 30, 35, 40, 45, 50 or about more than 50 thousand volts or any value or range of values therebetween in about 100 volt increments (e.g., about 4,400 volts, about 10,000 volts, about 22,900 volts, about 2,500 to 30,500 volts, etc.).
In an exemplary embodiment, Z is about 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120, 125, 130, 135, 140, 145, 150, 155, 160, 165, 170, 175, 180, 185, 190, 195, 200, 210, 220, 230, 240, 250, 260, 270, 280, 280, 300, 325, 350, 375, 400, 425, 450, 475, 500, 525, 550, 575, 600 or more millijoules, or any value or range of values therebetween in 1 millijoule increments (e.g., about 51 millijoules, about 100 millijoules, about 77 to about 424 millijoules, etc.).
In an exemplary embodiment, T is about 1 second, about 1 microsecond, or about 1 millisecond. In an exemplary embodiment, T is about 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 or more orders of magnitude more than the time it would take to transfer any one of the aforementioned values of for Z for anyone of the aforementioned values of Y for any one of the aforementioned values of X. By way of example only and not by way of limitation, for a value of X of 100 picofarads and a value of Y of 10,000 volts, a total energy flow to the grounded component is no more than 50 millijoules per second in some embodiments, no more than 50 millijoules per microsecond in some embodiments and/or no more than 50 millijoules per millisecond in some embodiments. Again, these features can be replicated in a laboratory environment to determine whether a given configuration meets at least one of any single possible permutation detailed above.
In an exemplary embodiment, the aforementioned T1 and/or T2 is about 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10 or more orders of magnitude more than the time it would take to transfer any one of the aforementioned values of for Z for anyone of the aforementioned values of Y for any one of the aforementioned values of X. By way of example only and not by way of limitation, for a value of X of 100 picofarads and a value of Y of 10,000 volts, a total energy flow to the grounded component is no more than 50 millijoules per second in some embodiments, no more than 50 millijoules per microsecond in some embodiments and/or no more than 50 millijoules per millisecond in some embodiments. Again, these features can be replicated in a laboratory environment to determine whether a given configuration meets at least one of any single possible permutation detailed above.
In at least some embodiments, the bone conduction devices detailed herein and/or variations thereof are configured such that configuration of such an embodiment meets at least one of any single possible permutation detailed above.
All of this said, in an exemplary embodiment, there is a removable component of a bone conduction device configured such that when (i) a 50 percentile male of U.S. citizenship or a European Union passport holder, completely naked, can move a distance of at least one of 5, 10, 15 and/or 20 meters without once separating the bottoms of his feet from a wool carpet having a pile of between 10 and 20 mm and without touching any other object constituting a ground until he has developed a static charge and a potential difference concomitant with such movement relative to the removable component (ii) subsequently picks up the removable component of the bone conduction device from a table having sufficiently high resistivity such that effectively none of the charge and or potential difference is dissipated and then (iii) subsequently couples the removable component of the bone conduction device to a titanium abutment passing through his skin and connected directly to a titanium bone fixture penetrating at least 5 mm into his mastoid bone such a substantial amount of the outer surface thereof is osseointegrated to the mastoid bone, the recipient at least one of perceives no shock associated with static discharge and/or a total energy flow to the removable component is no more than 50 millijoules per microsecond, or millisecond or second or ten seconds.
All of this said, in an exemplary embodiment, there is a removable component of a bone conduction device configured such that when (i) a 20, 30, 40, 50, 60, 70 and/or 80 percentile, or any value or range of values therebetween in 1% increments, male and/or female of U.S. citizenship or a European Union passport holder, completely naked, can move a distance of at least one of 5, 10, 15 and/or 20 meters without once separating the bottoms of his feet from a wool carpet having a pile of between 10 and 20 mm and without touching any other object constituting a ground until he has developed a static charge and a potential difference concomitant with such movement relative to the removable component (ii) subsequently picks up the removable component of the bone conduction device from a table having sufficiently high resistivity such that effectively none of the charge and or potential difference is dissipated and then (iii) subsequently couples the removable component of the bone conduction device to a titanium abutment passing through his skin and connected directly to a titanium bone fixture penetrating at least 5 mm into his mastoid bone such a substantial amount of the outer surface thereof is osseointegrated to the mastoid bone, the recipient at least one of perceives no shock associated with static discharge and/or a total energy flow to the removable component is no more than 50 millijoules per microsecond, or millisecond or second or ten seconds.
In this regard, in an exemplary embodiment, the only component between the metallic fastener and the abutment or abutment screw vis-à-vis the closest distance between the two is the plastic coupling.
It is noted that any method of manufacture described herein constitutes a disclosure of the resulting product, and any description of how a device is made constitutes a disclosure of the corresponding method of manufacture. Also, it is noted that any method detailed herein constitutes a disclosure of a device to practice the method, and any functionality of a device detailed herein constitutes a method of use including that functionality.
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. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.