Source: http://www.google.com/patents/US20020019669?dq=6233682
Timestamp: 2017-08-22 22:53:23
Document Index: 134993850

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 51', 'art 51', 'art 51', 'art 51', 'art 57']

Patent US20020019669 - Totally implantable cochlear prosthesis - Google Patents
A totally implantable cochlear prosthesis is presented. An externally-activated subcutaneous switch controls functions of the prosthesis. A pliable bridge connecting two hermetically sealed housing sections, and corrugated conductor lines, provide for future dimensional changes due to head growth. An...http://www.google.com/patents/US20020019669?utm_source=gb-gplus-sharePatent US20020019669 - Totally implantable cochlear prosthesis
Publication number US20020019669 A1
Also published as CA2384248A1, EP1233812A2, US6358281, US6648914, WO2001039830A2, WO2001039830A3
Publication number 09975970, 975970, US 2002/0019669 A1, US 2002/019669 A1, US 20020019669 A1, US 20020019669A1, US 2002019669 A1, US 2002019669A1, US-A1-20020019669, US-A1-2002019669, US2002/0019669A1, US2002/019669A1, US20020019669 A1, US20020019669A1, US2002019669 A1, US2002019669A1
Referenced by (132), Classifications (5), Legal Events (4)
US 20020019669 A1
1. An implantable cochlear prosthesis comprising at least two thin housings operatively connected to one another.
2. A totally implantable cochlear prosthesis comprising a coil and at least one housing containing control electronics, wherein said coil is located outside said housing but is operatively connected to said housing.
3. The prosthesis of claim 2 wherein said coil is an RF coil and is substantially not RF shielded.
4. The prosthesis of claim 3 wherein said coil comprises a plurality of turns of a biocompatible metal encapsulated in a bioinert carrier.
5. A totally implantable cochlear prosthesis comprising:
6. The prosthesis of claim 5 wherein said mechanically-actuated electrical switch includes a snap dome.
7. The prosthesis of claim 6 wherein said electrical switch further includes a biocompatible and pliable foil cover comprising gold, platinum, or both.
8. The prosthesis of claim 5 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs.
9. The prosthesis of claim 6 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs.
10. The prosthesis of claim 5 or 6 wherein said housing further contains various electronics and electrical interconnections, and wherein said electronics, electrical interconnections, electrical power storage means and electrical switch are mounted on one or more substrates, which substrate(s) contain a plurality of hermetically sealed electrical lead-throughs and wherein the substrate(s) material is substantially comprised of ceramic, glass or a combination thereof.
11. The prosthesis of claim 7 further comprising a cable containing wires connecting said coil, microphone and electrode array to said housing, and wherein an encapsulant is used to cover the various parts mounted on said substrate(s), which substrate(s) are further bonded to said cable, and wherein said electrical lead-throughs are connected to the wires contained within said cable.
12. The prosthesis of claim 11 wherein said encapsulant, and said gold and/or platinum foil cover are coated, firstly, with vacuum deposited gold, electroless deposited gold or electroless deposited palladium, such first layer then thickened using gold electro plating to create a hermetic seal over said encapsulant and said foil (covering the snap domes), and at the interface between the edges of the foil cover and the electro plated gold.
13. The prosthesis of claim 12 wherein the electro plated gold layer is substantially covered with a layer of medical grade silicone.
14. The prosthesis of claim 13 wherein the electro plated gold layer is covered with a layer of vacuum deposited titanium and/or vacuum deposited or electro deposited platinum, or a combination thereof.
15. The prosthesis of claim 14 wherein said titanium and/or platinum layer is further covered with a layer of medical grade silicon.
16. The prosthesis of claim 11 wherein the encapsulant contains hollow microballs and/or microcontainers containing a leak detection gas, such as helium, for testing housing hermeticity.
17. The prosthesis of claim 11 wherein the encapsulant is a medical grade epoxy and/or a bioinert polymer.
18. The prosthesis of claim 6 wherein said snap dome is comprised of stainless steel, titanium, plastic material, or any combination thereof.
19. The prosthesis of claim 7 further comprising a cable containing lithographically formed wires connecting said coil, microphone and electrode array to said housing, said cable comprising a polyfluorocarbon film.
20. The prosthesis of claim 19 wherein said cable is corrugated so as to be expandable.
21. The prosthesis of claim 19 wherein the polyfluorocarbon is FEP.
22. The prosthesis of claim 19 wherein the wires are comprised of platinum and/or gold.
23. The prosthesis of claim 1 or 2 wherein said housing(s) are hermetically sealed with a laser welded titanium enclosure, said enclosure containing a leak detection gas for testing enclosure hermeticity.
24. The prosthesis of claim 1 wherein the housing(s) are hermetically sealed using a ceramic and/or titanium enclosure.
25. The prosthesis of claim 1 wherein said housing(s) are hermetically sealed using a ceramic having an edge and wherein said edge is coated with titanium to allow said edge to be subsequently laser welded, and wherein the enclosure contains a leak detection gas for testing enclosure hermeticity.
26. The prosthesis of claim 2, said coil having an inner diameter that is substantially open in a ring-like configuration, such shape allowing skin overlaying said coil to bond to the skull within said open area post implantation.
27. The prosthesis of claim 1 wherein said housings are disc-shaped and are connected by a pliable connector.
28. A cochlear prosthesis assembly comprising:
the prosthesis of claim 2 providing a magnetic field; and,
This application is a continuation of application Ser. No. 09/450,025 filed Nov. 29, 1999.
Human deafniess results from numerous sources including trauma, ear infections, congenital factors, ototoxic effects of some antibiotics, and from diseases such as meningitis. Sensorineural damage (damage to the hair cells in the cochlea) is the largest single form of hearing loss. In a healthy ear these hair cells convert acoustic signals in the inner ear to electrical signals that can be interpreted by the brain as sound. It is estimated that over 7% of the U.S. population is affected by sensorineural deafness, and one in a thousand infants is born totally deaf. Extrapolating these percentage figures, it is estimated that there are more than 30 million people in the world who are profoundly deaf.
[0010]1. An implanted part, and
[0011]2. An external part
[0049]FIG. 1 shows an isometric view of the preferred embodiment of the implanted part of the invention, showing the two housing sections, the coil, the microphone, the electrode array, and the connector lines, including the corrugations thereon, joining the microphone and electrode array to the pliable bridge between the housing sections.
[0050]FIG. 2 illustrates a cross-sectional view of the two housing sections, including the key components therein, and the connecting bridge between said sections.
[0051]FIG. 3 is a lateral view of the left side of the head showing the implanted parts of the invention in place, said view also illustrating one embodiment of an incision on the head to gain access for implantation.
[0052]FIG. 4 illustrates an posterior-lateral view of the implanted part of the invention in place, said view also showing the coil, the two housing sections (placed against the skull, posterior of the pinna), the microphone (anchored within the auditory canal) and the electrode array (positioned within the cochlea).
[0053]FIG. 5 shows a coronal diagrammatic view of the pinna, auditory canal, mastoid cavity, tympanic membrane, semicircular canals, and cochlea, with the implanted parts of the invention in place.
[0054]FIG. 6 depicts a horizontal cross-sectional view of ear canal, mastoid, middle ear and cochlea, illustrating an inventive surgical approach requiring only one cavity excavation to gain entry for both the electrode array and microphone.
[0055]FIG. 7 depicts a lateral view of the left side of the head illustrating a convenient method for activating the volume control switch by pressing, with a finger, against the surface of a housing section. (The skin covering said housing section is not shown).
[0056]FIG. 8a depicts a cross sectional view of a housing section, positioned subcutaneously against the skull, showing a finger located just above the skin overlaying the snap dome contained within said housing section.
[0057]FIG. 8b depicts a cross sectional view of a housing section, positioned subcutaneoulsy against the skull, showing a finger compressing the skin and the underlying snap dome, causing the snap dome to “snap” and the piezoceramic disc underlying the snap dome to slightly bend.
[0058]FIG. 9 is a lateral view of the left side of the head showing a stand-alone charging device, containing a coil, battery and electronics, said device mounted onto a standard eyeglass frame, such that said coil is positioned substantially over the internal coil.
[0059]FIG. 10 is a lateral view of the left side of the head showing a remotely powered coil, said coil mounted onto a standard eyeglass frame and attached via wires to a body-worn device, said device containing battery and electronics.
[0060]FIG. 11 is a lateral view of the left side of the head showing a remotely powered coil, said coil mounted onto a standard eyeglass frame and attached via wires to a device, such as a computer, for programming and or modifying, via an inductive link, the parameters within the implanted electronics.
[0061]FIG. 12 is a lateral view of the left side of the head showing an alternate method, similar to that shown in FIG. 9, for positioning the external coil substantially over the internal coil so as to charge the internal battery.
[0062]FIG. 13 is a lateral view of the left side of the head showing a stand-alone charging device, containing a coil, two magnets, battery and electronics, said device both magnetically attached to the head, and also configured such that said two magnets rotationally align with two opposing internal magnets, such rotational alignment of said charging device ensuring that said coil is positioned substantially over the internal coil.
[0063]FIG. 14 illustrates one embodiment to achieve rotational alignment of opposing magnets contained within the stand-alone charging device shown in FIG. 13, and opposing magnets contained within one housing section of the implanted part, so as to substantially align the external coil and implanted coil, one over the other.
FIGS. 15 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is inferior.
FIGS. 16 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is anterior.
FIGS. 17 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is between the housing sections.
FIGS. 18 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is posterior and all elements are aligned substantially horizontally.
[0068]FIG. 1 shows an isometric view of the preferred embodiment of the implanted part 1 of the invention. Said invention 1 is comprised of two housing sections 2 and 3, a coil 4, identification markers 5, a pliable (or bendable) bridge 6, corrugated connections 7 and 8, a microphone 9 and an electrode array 10. All materials in contact with tissues are preferably comprised of biomaterials such as gold, platinum, palladium, tantalum, rhenium, rhodium, titanium, medical grade silicone and bioinert polymers, such as the polyfluorocarbons, and specifically the fluoropolymer FEP. A review of biomaterials can be found in a book edited by A. F. von Recum titled “Handbook of Biomaterials Evaluation”, ISBN 0-02-42-42311 0-X.
[0074]FIG. 1 also illustrates some “identification markers” 5, preferentially dots, squares, bars or similar symbols, located with the inside perimeter of the coil 4, which markers 5 can be used to post operatively identify the serial number, model number and/or date of the implanted part 1, such identification being useful for future reference where such datum is not readily available using other means. Said marker can be fabricated from a biocompatible metal such as platinum, gold or titanium encased, or not, in a carrier material, and identified, in vivo, using medical imaging, for example, X-rays or a CT scan. Any marker designs can be used, at any locale attached to, or near, the implanted part of the invention for post implant identification, such designs being within the scope and spirit of the invention. Since the resolution of X-rays scans is about 0.3 mm, it is also possible to simply use letters, numbers or such similar symbols for the serial number, model number or date for implant identification.
[0077]FIG. 2 illustrates a cross-sectional view of the housing sections 2 and 3, and bridge section 6, showing the internal components thereof, namely, the battery 18, piezoceramic 19 (and snap dome 20) for the panic “off/on” switch, and the electronics 21 (for example an ASIC chip), the piezoceramnic 22 (and snap dome 23) for the volume control. The location of said components within the housing sections 2 and 3 is for illustration purposes only. It will be appreciated that other relative locations of the components within the housing are possible.
[0083]FIG. 2 also illustrates the implanted rechargeable battery 18 housed within housing section 2. Alternately, a capacitor can be used as a short term rechargeable power storage device. Said battery 18 can be conveniently recharged, transcutaneously, from time to time, using an external device 51 (see FIG. 9) to inductively couple power to the internal coil 4, such power transfer able to charge the internal battery 18 using appropriate electronics.
[0087]FIG. 3 is a lateral view of the left side of the head illustrating the preferred location of the implanted part 1, showing housing sections 2 and 3, bridge 6, coil 4, corrugated connections 7 and 8, microphone 9 and electrode array 10. Surgical implantation of said invention can be accomplished during a local or total anaesthetic. Line 34 illustrates one incision whereby the surgeon raises a postauricular flap to implant the various parts of the invention. The thin housing sections 2 and 3 can be placed against the skull, or even adjacent the dura in infants, without excavating skull bone to recess such housing sections. The microphone 9 is positioned behind the skin in the posterior wall of the external auditory canal, whereas the electrode array 10 can be inserted by any approach which gives access to the round window or basal turn of the cochlea 35. However, the preferred surgical procedure is preferably carried out by either a mastoidectomy and facial recess approach, or by a transcanal approach or by a combination thereof at the surgeon's discretion.
[0089]FIG. 4 illustrates a posterior-lateral view of the surgical area showing the implanted part of the invention with the coil 4 and housing sections 2 and 3 placed against the skull 36 posterior to the pinna 37, the microphone 9 (the housing of which is shown positioned posteriorly, as two circles with dashed lines) anchored within the auditory canal 38 and the electrode array 10 positioned within the cochlea 35. A key feature of said implanted part 1 is that the housing sections 2 and 3, and coil 4 are sufficiently thin, preferably less than about 2.0-2.5 mm in thickness, to allow these devices to be placed directly against the skull surface 36, or between the skin layer covering the skull, without the need to surgically excavate skull bone, where said housing sections 2 and 3 can be sutured to the overlaying skin, or anchored to the underlying skull 36 with suture lines or screws, so as to minimize movement of said housing sections post operation.
[0090]FIG. 5 shows a coronal section of the pinna 37, auditory canal 38, mastoid 39, semicircular canals 40, tympanic membrane (or eardrum) 41 and cochlea 35, with the implanted part of the invention in place. The surgeon can enter the middle ear 42 via the mastoid cavity 39 preferably using a local anaesthetic.
[0091]FIG. 6 depicts a cross-sectional horizontal view of the ear canal 38, middle ear 42 and cochlea 35 illustrating a surgical approach having only one cavity excavation 43 to gain entry for both the electrode array 10 and microphone 9. An introducer, which is thin enough to pass through the retro-facial triangle can be used for inserting the electrode array 10 into the cochlea 35 through a smaller bony dissection than is now possible using conventional techniques. Microphone 9 is implanted substantially in the locale of the posterior wall 45 of the external auditory canal 38, such location taking advantage of the natural resonance of said auditory canal 38. Sound pressure in the auditory canal 38 near the location of the microphone 9 is advantageously enhanced, especially for some key voicing frequencies (see for example, A. E. Deddens, et. al., Am. J. Otolaryngol, 11:1-4, 1990; and J. A. Feigin, et. al., Ear and Hearing, Vol. 11, No. 5, 1990). To position the microphone 9, the surgeon first creates a small mastoidectomy cavity and elevates the skin of the posterior wall 47 of the external auditory canal 38. The bony wall 46 between the mastoid cavity 43 and the external auditory canal 38 is thinned. A hole is created in the posterior wall 47 of the external auditory canal 38 about half way between the tympanic ring and the meatus of the external canal 38. This hole is made substantially to the dimensions of the microphone housing 9, using an appropriately sized drill bit and a custom designed hand tool. Facia is packed around the microphone housing 9 to secure it in position.
[0092]FIG. 7 illustrates a lateral view of the left side of the head showing a convenient method for activating the volume (or panic “off/on”) switches by using a finger 48 to push against the skin covering housing sections 2 or 3. (Note that the skin covering said housing sections 2 and 3 is not shown for clarity of illustration). FIGS. 8a and 8 b illustrate the details of the activation method shown in FIG. 7. FIG. 8a shows finger 48 against skin 49 overlaying housing section 2. FIG. 8b shows finger 48 pushed against skin 49 said skin 49 being compressed 50, thereby causing snap dome 20 to suddenly “snap” and impact against support disc 32, said impact causing piezoceramic element 19 to slightly flex creating a voltage. Said voltage is sensed by the electronics in housing 3 to control volume (or panic “off/on”). A similar snap dome activation switch is incorporated into housing section 3. The choice of which housing section in which to locate the electronics and battery is not critical, nor is the choice as to which housing section contains the volume or panic “off/on” switch.
[0093]FIG. 9 is a lateral view of the left side of the head showing the preferred embodiment, with an external part 51, containing a coil, battery and electronics, mounted onto a standard eyeglass frame 52, said external part 51 positioned substantially over the internal coil 4 (shown in FIG. 3). Such external part 51 can be conveniently held to the head by the user from time to time to recharge the implanted battery, or in an alternate embodiment, to recharge any electrical storage device contained within the implanted part. The use of a standard eyeglass frame allows a convenient and aesthetically acceptable method to accurately and repeatably position the coil in said external part 51 substantially over the internal coil 4 (shown in FIG. 3), so as to inductively couple power and data between the external and internal coils.
[0094]FIG. 10 is a lateral view of the left side of the head showing an alternate embodiment, with a coil 53 attached to eye glass frame 52, with said coil 53 positioned substantially over the internal coil 4 (shown in FIG. 3). Power to coil 53 is supplied by wires 54 attached to a remotely located energy source 55 said source powered by a body-worn primary or secondary battery, or, alternately, by AC wall plug power.
[0095]FIG. 11 is a lateral view of the left side of the head showing one method for programming and or modifying the parameters within the implanted electronics. Such programming can be conveniently accomplished post-operatively, from time to time, by inductively coupling data between the internal 4 and external 53 coils using a computer 54, or similar control device, attached to the external coil 53.
[0096]FIG. 12 is a lateral view of the left side of the head showing an alternate method, similar to that shown in FIG. 9, for positioning an external device 55 (containing a coil, electronics and a battery) substantially over the internal coil 4 so as to charge the internal battery 18. Such alternate method uses a modification of a conventional BTE (behind-the-ear) hearing device as the mechanical support structure 56 onto which said external device 55 is mounted. A further embodiment is to mount only the coil on the BTE frame 56, and supplying power and/or data to said coil using an external power and/or computer similar to that shown in FIGS. 1 0 and/or 11.
[0097]FIG. 13 shows a lateral view of the left side of the head with the external part 57 (containing a coil, battery and electronics) magnetically attached to the head using opposing magnets, with at least two internal magnets and at least two magnets outside the head. Most conventional cochlear prostheses use such opposing magnets (one internal and one external) to hold an external device to the head. The magnets in such conventional devices are generally contained within the perimeter of the coil to align the external and internal coils, such arrangement acting to reduce the inductive power coupling due to presence of a conductive material within the RF inductive field. An inventive feature of the device is shown in FIG. 13, where the magnets and coil are not coaxial.
[0098]FIG. 14 shows the necessary rotational orientation of the magnets (so as to substantially align the external coil 59 and internal coil 4, one over the other) which orientation can be conveniently accomplished by having two opposing pairs of magnetic poles interact as illustrated by the magnetic lines of force 58.
[0099]FIGS. 15, 16, 17, and 18 illustrate alternate embodiments for some of the possible configurations for the implanted part of the invention, showing the coil 4 and the two housing sections 2 and 3.
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