text:
|Publication number
|Publication type
|Application number
|Publication date
|Nov 18, 2003
|Filing date
|Oct 15, 2001
|Priority date
|Nov 29, 1999
|Fee status
|Also published as
|Publication number
|Peter G. Berrang, Henry V. Bluger, Stacey D. Jarvin, Alan J. Lupin
|Original Assignee
|Epic Biosonics Inc.
|Export Citation
|BiBTeX, EndNote, RefMan
|Patent Citations (8), Referenced by (97), Classifications (6), Legal Events (4)
|External Links: USPTO, USPTO Assignment, Espacenet
This application is a continuation of application Ser. No. 09/450,025 filed Nov. 29, 1999 now U.S. Pat. No. 6,358,281.
This invention relates generally to human hearing, and more specifically to the design and surgical insertion and positioning of a totally implantable cochlear prosthesis.
Human deafness 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.
Currently available cochlear prostheses generally use an internal part containing an electrode array for insertion into the cochlea, and at least some electronics in a sealed subcutaneous package. Information is inductively transmitted through the skin via a head-mounted (magnetically held) device to the subcutaneous package, which package is designed to receive and process coded information for further transmission to the electrode array. The battery and a major part of the acoustic signal-processing electronics are housed in an externally worn device. These designs are not aesthetically pleasing, nor practical for sleeping or for other activities such as diving, swimming or other physical activities. Besides the inconvenience of said designs, there is a social stigma, especially for children, in wearing a head-mounted device, connected to an externally visible apparatus. Additionally, the length of surgery and the surgical complexity of implanting current commercial cochlear prostheses is significant, especially for very young and for very old persons. Said implant procedure involves exposure of the mastoid cortex and external auditory canal of the implanted ear via elevation of a postauricular skin flap, generally requiring 2-4 hours where the patient is totally anesthetized, with the inherent medical risks of total anesthetic. Finally, the cost of said cochlear prostheses is high, limiting the availability of this technology mostly to the wealthy industrialized countries.
In spite of the surgical risks, complexity and device costs, currently available cochlear prostheses do provide a major improvement over the alternative—total deafness. However, there are still great differences in hearing percepts amongst implanted patients. Some patients after implantation are able to use the telephone, while others can only perceive environmental sounds.
Such cochlear prostheses are commercially available from a number of companies worldwide, for example, from Cochlear Limited, Sydney, Australia; Advanced Bionics Corporation, Sylmar, Calif., U.S.A.; Med-El Medical Electronics, Innsbruck, Austria; PHILIPS-Antwerp Bionic Systems N.V./S.A., Edegem, Belgium; and MXM Medical Technologies, Vallauris, France. A comprehensive introduction to the development of cochlear implants is given in, for example, "Cochlear Prostheses," edited by G. M. Clark, Y. C. Tong and J. F. Patrick, distributed in the U.S.A. by Churchill Livingstone Inc., New York, N.Y. (ISBN 0-443-03582-2), and in "The Cochlear Implant," (ISSN 0030-6665) by T. J. Balkany, editor of The Otolaryngologic Clinics of North America, Vol. 19, No. 2, May, 1986. Some of the early cochlear implant work is also described in, for example, U.S. Pat. Nos. 4,357,497; 4,419,995 and 4,532,930.
Although a commercial totally implanted cochlear prosthesis does not yet exist, A. J. Maniglia in U.S. Pat. No. 5,906,635 and A. J. Maniglia, et. al. in "The Middle Ear Bioelectronic Microphone for a Totally Implantable Cochlear Hearing Device for Profound and Total Hearing Loss", in The American J. of Otology, 20:602-611, 1999, describe a possible design for a totally implanted device. Their proposed device uses a permanent magnet attached to the malleus which movement is detected by a nearby coil so as to detect vibrations of the ear drum. Said design uses a relatively complex arrangement of hermetically sealed packages, rods and brackets. A separate external RF linked unit is used to control the volume and on/off functions. The Maniglia prior art has a number of shortcomings namely: (a) said design is not MRI compatible, (b) a large excavation is required in the mastoid cavity to anchor and position said device, (c) mounting a magnet directly onto the ossicular chain can reduce the blood supply, creating the danger of future necrosis of the bone, (d) the device is not suitable for use in newborns, (e) there is no manual panic safety off switch, and (f) there is no allowance for future head growth between the various permanently anchored mounting brackets.
A totally implantable cochlear prosthesis of the present invention is designed to address the limitations of the prior art and to: (a) significantly improve the aesthetics and practical problems of coping with the relatively bulky external components of conventional cochlear prostheses, (b) allow the user to hear more naturally via the auditory canal (ear canal) and (c) enable versatile speech processing algorithms to be used to stimulate the auditory nerve cells for improved speech perception. Additionally, the implant is designed to reduce the surgical complexity and time needed by the surgeon for device implantation.
In one of its aspects, the invention comprises two parts, namely:
1. An implanted part, and
2. An external part
The implanted part itself embodies further aspects of the invention. The implanted part comprises four principal components:
(a) a housing
(b) a coil
(c) a microphone, and
(d) an electrode array
1. The Implanted Part
The implanted part is a stand-alone fully functional cochlear prosthesis, such functionality only limited by the capacity of the battery, or other storage device, contained within the implant housing. Said implanted part is comprised of a housing, coil, microphone and electrode array, where all components in contact with body tissues are biocompatible, and all non-biocompatible materials are substantially hermetically sealed with biocompatible materials. Such hermetic sealing is required to prevent ingress of biological fluids into the enclosure, creating device malfunction, and/or to prevent leakage of non-compatible material into the surrounding biological tissues. Medical devices such as conventional cochlear prostheses or pacemakers commonly use titanium enclosures (or ceramic enclosures with metal sputtered bonding surfaces) which are hermetically sealed using laser welding. For a brief review of sealing concepts, see for example, S. J. Rebscher's article in Chapter 4 (Cochlear Implant Design and Construction), published in Cochlear Implants, ed. Roger F. Gray, Croon Helm Ltd., London, 1985.
The preferred embodiment is to position the housing and coil substantially against the skull, posterior to the pinna, with the electrode array entering the middle ear via a mastoid cavity and facial recess approach, using either a modified version of a cochleostomy in conjunction with a transcanal approach. Such surgical cavity also allows for convenient positioning of the microphone underneath the skin in the posterior wall of the external auditory canal.
The connections from the microphone and electrode array to the housing are comprised of, preferably, platinum and/or gold wires formed lithographically, said wires encapsulated in a bioinert polymer, such as the fluorocarbon polymer FEP. Said connections are "corrugated" to enable the connections to expand with minimum stress during surgical handling, skull growth, and any post surgical movement of the implanted components.
(a) The Housing
The housing, which contains the wiring interconnections, electronics, battery, means for setting volume and safety "off/on", and, in an alternate embodiment, magnets, is positioned substantially against the skull behind the outer ear (or pinna) where said housing can be conveniently sutured to the overlying tissue or attached to the underlying bone with sutures, or titanium screws. Said housing comprises two sections, each section having a relatively thin and rounded profile at the edges, where such sections are joined by a pliable (or bendable) bridge to allow the surgeon to bend said bridge so as to better fit the two housing sections to the curved surface of the skull.
The key components within the housing sections are mounted on an insulated substrate (containing hermetically sealed electrical lead-throughs), where the substrate is comprised of ceramic or glass or a combination thereof, but preferentially ceramic, where the substrate is further bonded to an underlying cable, preferably a ribbon type cable, containing wires, where said ribbon cable is preferably comprised of a bioinert polymer film encapsulating lithographically formed wires. Openings within the polymer film allow electrical connections to be made from said conducting wires to the overlying ceramic substrate lead-throughs. The polymer film is then further bonded to an underlying gold foil substrate. Since some of said components may be comprised of non-biocompatible materials, they require complete hermetic or hermetic like sealing on all surfaces. The preferred embodiment to achieve such all surface sealing is to use a medical grade epoxy to cover said components (mounted onto the ceramic substrate), where said epoxy also provides shape to the overall housing. Alternately, any conformable potting material, such as a bioinert polymer, can be used as an encapsulant material to cover said components. Since epoxy, or other, encapsulation (over the ceramic substrate) does not provide a true hermetic or hermetic like seal, said encapsulant surface is coated first, preferably, with a thin coating of vacuum deposited gold, or alternately, with an electroless gold deposition, where such a first coating of gold is subsequently thickened by an electro deposition of gold. Alternate embodiments include coating the electro deposited gold layer with titanium (or platinum), and/or with medical grade silicone. The same gold coating processes are also used to provide a gold seal between the bridge connecting the two housing sections, and the point at which the connectors from the microphone and electrode array enter the housing bridge.
Since the encapsulant substantially covers the components within the two housing sections, in one embodiment, hollow beads or microcontainers containing, for example, helium gas and or other leak detection gases, are positioned within the encapsulant to act as a leak detection gas using standard quadrupole mass spectrometry, such gas leak detection system acting to verify the extent of the housing hermeticity.
In further embodiments, a laser, ultrasonic or electric welded titanium, ceramic (or a hybrid of both) enclosure may be used as the housing. For any ceramics used, these would need to be coated with titanium at any locations required for subsequent welding.
The various electronics within the housing should draw minimal power, and occupy a relatively small volume. The preferred embodiment is to use a custom designed low power hybrid analog-digital ASIC microchip for processing signals from the microphone and for controlling the current pulses to the cochlear electrodes. Alternately, a more conventional DSP based electronics design can be used, such design using a combination of standard and/or custom circuits. However, such a DSP design generally requires more power and space. The key advantages of using an analog-digital microchip are that such a device has very low power requirements, occupies a very small volume, and is inherently more reliable than using numerous discrete electronic components.
For the preferred embodiment, a thin film secondary (rechargeable) lithium battery is located in one housing section. Preferably, such a battery should have high charge density, be substantially rechargeable over tens of thousands of charge/discharge cycles, and use a safe solid state electrolyte. Alternately, a rechargeable nickel metal hydride battery can be used, although such a battery has a relatively low charge/discharge cycle capability, thus requiring surgical replacement every few years. A further alternate embodiment is to use a simple capacitor for short term storage of electrical power, in lieu of a battery storage system, where such a design would be used in conjunction with an externally-worn head mounted inductively coupled power input device worn continuously by the implantee.
Control of power and volume to the implanted part can be accomplished in a myriad of conventional ways, such as an RF link, IR light pulses, or acoustic signals through the skin. However, the invention uses a mechanical method to operate a panic "off/on" control, and an overall "volume" control. A panic shut off of the electronics is preferred in the event of device failure which could send excessive current to the cochlea electrodes, damaging the neural processes therein. However, such a safety shut off is preferably independent of the control electronics and should be capable of being quickly implemented by the user, in any setting. Ideally, the panic "off/on" control does not need a sophisticated external device to activate said control. According to the invention, a panic "off/on" control incorporates a pressure switch (located within a housing section), preferably a piezoceramic or piezocrystal disc (or a bimorph) mounted on a thin metal diaphragm, where such diaphragm can be slightly bent by the user by simply pushing (ie. with a finger) against the skin behind the pinna, thus producing an electrical signal from the piezoceramic that can be used by the electronics to control the panic "off/on" switch. In an alternate embodiment, a piezoelectric film such as PVDF (polyvinylidene fluoride), or copolymers of PVDF, produced by Measurement Specialties, Inc. of Valley Forge, Pa. can be used, where said piezo film is held in a "drum-like" configuration. The surface of said film can be (indirectly) pressed, through the skin surface, by the user by simply pushing (ie. with a finger) against the skin behind the pinna. Such pressure slightly deflects the PVDF film membrane inducing sufficient current and voltage to the control electronics to disengage power to the electrodes in the cochlea. In an alternate embodiment a mechanically-actuated electrical switch for the panic "off/on" switch can also be used in place of a piezo type device. To assist the implantee with a tactile sense as to when a contact is made, a snap dome can be used in conjunction with the piezo type panic "off/on" switches, or the mechanically-actuated electrical switches. Also, the use of a snap dome provides for a better signal since the operation of the piezo type or mechanical type switch will be suddenly activated when the pressure on the snap dome reaches a certain value.
In yet a further embodiment, a second panic "off/on" control using a magnetic reed switch is located in a housing section, which switch is normally in the closed mode, except when exposed to a magnetic field, such field opening the reed switch, disengaging power to the electrode array. The user can simply hold a magnet against the skin substantially over said switch thereby inducing a magnetic field through the skin to activate the reed switch. Removing the external magnet would close the reed switch thereby activating the implanted prosthesis again.
A piezoceramic or piezocrystal disc (or bimorph) or, alternately, a PVDF type piezo film can also be used as a "volume" control switch, similar to the panic "off/on" control design, to enable the user to adjust the volume "up" or volume "down" so as to achieve the preferred sound level. Said "volume" control can be mounted within one of the housing sections, and activated through the skin surface by the user pushing (ie. with a finger) against the skin behind the pinna, such pressure producing sufficient current and voltage from the piezoceramic, piezocrystal or piezo film material to activate the appropriate microelectronic circuits. In an alternate embodiment a mechanically-actuated electrical switch can also be used in place of a piezo type device. To assist the implantee with a tactile sense as to when a contact is made, a snap dome can be used in conjunction with the piezo type panic "off/on" switches, or the mechanically-actuated electrical switches. Also, the use of a snap dome provides for a better signal since the operation of the piezo type or mechanical type switch will be suddenly activated when the pressure on the snap dome reaches a certain value.
(b) The Coil
An external coil and an implanted coil are used to inductively couple electrical power and data through the skin surface. This technology is well established: see for example, Chapter 7 of "Design and Fabrication of an Implantable Multichannel Neural Stimulator", by M. Soma, June 1980, Technical Report No. G908-1, National Institute of Health Contract No. N01-NS-5-2306; and "High-Efficiency Coupling-Insensitive Transcutaneous Power and Data Transmission Via an Inductive Link", C. M. Zierhofer, et. al., IEEE Transactions on Biomedical Engineering, vol. 37, no. 7, July 1990. Also, a myriad of patents addressing various methods for improving or modifying such inductive links have issued, see for example, U.S. Pat. Nos. 4,441,210; 5,070,535; 5,279,292; 5,876,425; and 5,891,183. Unfortunately, the inductively coupled signal is attenuated by metallic layers present over the coil or metallic parts (such as magnets) contained within the coil perimeter. Such attenuation is also a function of the frequency of the transmitted signal.
The preferred embodiment of the present invention uses two RF coupling coils which are not RF shielded, and locates the implanted coil outside the housing. The coil comprises a number of turns of a biocompatible metal, such as platinum, titanium, gold, tantalum, iridium, rhodium, or rhenium, or any combination thereof, encapsulated in a bioinert polymer carrier, preferably a polyfluorocarbon such as FEP. The coil can be fabricated using discrete wires, or preferably, using lithographed tracks. An added advantage of such a design is that the coil has a very thin profile, and is flexible, thus fitting easily to the curved skull surface. Also, the center area within the coil may be made substantially "open", such a design minimizing the surface area separating the skull and overlying skin. A further advantage of the invention is the absence of a subcutaneous magnet or magnetizable material, within the coil perimeter, or housing, thus enabling an implantee to have an MRI scan without explantation of part or all of the implanted prosthesis. Commercial cochlear prostheses containing implanted magnets can restrict the user from having an MRI scan (see for example, B. P. Weber, et. al., vol. 19, no. 5, pages 584-590, 1998, American J. of Otology).
Also, it is advantageous to include a method for identifying the model, date or serial number of the implant, post surgery, using a non-invasive technique such as X-ray, CT scan or other medical imaging methods. Such identification can be conveniently accomplished by locating numbers, letters, marks or other identifying symbols substantially on the inside or outside perimeter of the coil, where such identifying markings can be conveniently fabricated lithographically in, for example, platinum or gold within a polymer film, such film also containing the coil wire, or lithographed coil tracks. Alternately, said markings can also be located anywhere on the implanted part where such markings would be identifiable using medical imaging methods.
(c) The Microphone
In the preferred embodiment a small microphone is encapsulated in a bioinert material such as titanium, gold, platinum, iridium, tantalum, rhodium or rhenium, or a polymer, such as a polyfluorocarbon, or any combination thereof, but preferably a titanium housing, said encapsulated microphone anchored in the posterior wall of the external auditory canal. A small mastoidectomy cavity is created surgically and the skin of the posterior wall of the external auditory canal is elevated. The bony wall between the mastoid cavity and the external auditory canal is thinned down to match the dimensions of the encapsulated microphone. A hole is created in the posterior wall of the external auditory canal about half way between the tympanic ring and the meatus of the external canal. This hole is also made substantially to the dimensions of the encapsulated microphone, using an appropriately sized drill bit and a custom designed hand tool. The thin diaphragm, preferably titanium, covering the sound input part of the encapsulated microphone, is fitted so as to lie underneath the skin of the posterior wall of the external auditory canal. In an alternate embodiment, a protective cap is placed over the titanium diaphragm during handling to protect it from damage.
Sound entering the user's auditory canal, will be received by the microphone, with the acoustic signal converted to an electrical signal within the microphone, where the electrical signal is then sent to the electronics within the housing for signal processing. One or more of numerous signal processing strategies may then be used to send electrical current pulses to the electrode array for stimulating the auditory nerve fibers, such stimulation being perceived by the user as sound.
(d) Electrode Array
The description of the preferred embodiment of the electrode array is disclosed in U.S. patent application Ser. No. 09/376,918 which is incorporated herein by reference. However, any compatible electrode array could be attached to the housing.
2. The External Part
An external part is required from time to time to recharge the battery, or other storage device, contained within the implanted housing. Such recharging of the internal battery (or other storage device) can be conveniently accomplished by, for example, using an external part to inductively couple power through the skin surface to an implanted receiving coil contained within, or preferably outside of, the implanted housing whereby the electrical power received by the implanted coil is used to charge the implanted battery (or storage device). Such external part is preferably held to the head either by mechanical means or, alternately, by magnetic means. For the preferred embodiment, the external coil is mounted behind the pinna on the arm of the frame of eye glasses, such that the external coil substantially overlays the implanted coil. Power to the external coil can be provided by including a battery (which itself may be rechargeable) and control electronics attached to the eye glass frame, or via a wire to a body-mounted power source. Alternately, the external coil can be mounted behind the pinna using a standard "BTE" device (like a behind-the-ear hearing aid package) to anchor and position the external coil substantially over the implanted coil. Power to the external coil can be provided by mounting the battery and control electronics directly on the BTE device, or via a wire to a body mounted power source.
A further embodiment is to use an arrangement of external and implanted magnetic fields to both hold the external part against the head and to also rotationally align said external device, such rotational alignment enabling the external coil and implanted coils to be substantially coaxial to achieve optimum inductive coupling. Such rotational alignment between the external and internal magnetic fields is necessary since the magnets and coil in each of the external and implanted parts are separated (ie. the magnet is not placed within the coil perimeter).
A yet further embodiment is to use a conventional method of alignment whereby opposing external and implanted magnets (which are each coaxial with and contained within the coil perimeter) are used such that the external part will be magnetically held against the head to position the external coil substantially over the implanted coil.
The external and implanted coils can also be used to transmit and or receive coded information to/from the electronics in the implanted housing to control or monitor electrical parameters in said housing.
In a yet farther embodiment, the external part can be connected to a computer such that data can be generated by said computer to transmit electronic signals to the implanted part to change the parameters within the electronics of the implanted part.
For the embodiments where the external part contains a battery, such battery may be a secondary (or rechargeable) battery, or, in an alternate embodiment, a primary battery that is discarded after usage.
The preferred and alternative embodiments of the invention will be described by reference to the accompanying drawings, where anterior is towards the front, posterior is towards the rear, superior is up, inferior is downwards, and lateral is away from the median of the head.
For drawings that show the right side of the head, such drawing would be equally applicable for the left side of the head. All references for the left side are applicable for the right side, and visa versa.
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.
FIG. 2 illustrates a cross-sectional view of the two housing sections, including the key components therein, and the connecting bridge between said sections.
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.
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).
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
FIG. 15 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is inferior.
FIG. 16 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is anterior.
FIG. 17 illustrates an alternate embodiment for the configurations of the coil and two housing sections, where the coil is between the housing sections.
FIG. 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.
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 0-02-42-423110-X.
The preferred embodiment of the housing is comprised of two sections 2 and 3 connected by bridge structure 6 containing a pliable metal (such as gold or platinum) so as to substantially allow a bent shape on insertion, such bendable bridge 6 allowing the surgeon to better fit the housing sections 2 and 3 to the curvature of the implantee's skull, especially for the small skulls of infants and children, and to allow for future skull growth. The housing sections 2 and 3 and bridge structure 6 are preferentially coated with gold, and, in a further embodiment, further coated with titanium, platinum, medical grade silicone, or any combination thereof.
For surgical reasons, the housing sections 2 and 3 should be as thin as possible to minimize the "bump" on the skin overlaying the housing sections 2 and 3, and to minimize the likelihood of trauma. In infants such skin thickness varies from about 1 mm to 1.5 mm, and in adults from 3 mm to 6 mm. Relatively thin housing sections 2 and 3 allow the surgeon to lay said sections substantially against the skull bone, generally without the need to excavate underlying bone. For the preferred embodiment, the housing thickness of sections 2 and 3 is about 2.0 to 2.9 mm with the edges 11 of said housing sections 2 and 3 rounded to minimize the entrainment of fluid or air pockets (to minimize creating a nidus for infection), and to prevent gradual erosion of the device through the skin. In an alternate embodiment, the housing sections are thicker than 2.9 mm, namely about 3 mm to 5 mm, in which case such thickness generally requires some excavation of skull bone to sink the housing into said bone, thus lowering the housing profile to protect the implantee from trauma.
Sections 2 and 3 each have a diameter of about 10 mm to 40 mm, preferably about 20 mm to 25 mm., such dimension containing all required components and providing the least disruption of tissue planes.
The coil 4 is comprised of a plurality of turns of biocompatible wire 12, or preferably, wire formed lithographically via electro or electroless deposition, or via chemical etching of metal foil. The wire 12 can be made of platinum, gold, iridium, tantalum, palladium, rhodium, rhenium or alloy thereof, where said wire 12 is preferentially encapsulated in a bioinert polymer layer 13, such as a polyfluorocarbon, specifically the fluoropolymer FEP, where such polymer layer 13 is about 20-500 μm thick, preferably about 20-30 μm, where the cross-sectional area of said wire 12 is about 0.0005-0.1 mm2 preferably about 0.01 mm2. Said coil has an outer diameter of about 15-30 mm and an inner diameter of about 10-20 mm, preferably an outer diameter of about 20 mm and an inner diameter of about 15 mm. Such coil design has the advantage of having a thin profile, being flexible to better conform to the skull radius and occupying a minimum footprint between the skull and overlying skin. A key inventive feature of said coil 4 is that it is located away from interfering metal materials, especially magnetic materials, thereby improving the inductive power coupling efficiency across the skin surface between the internal and external coils.
Alternately, any conductor material encased in a biocompatible material or enclosed in a biocompatible container may be used to fabricate said coil.
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.
The microphone 9 is preferably a small commercially available microphone, where said microphone 9 is hermetically encapsulated in a biomaterial (such as titanium) casing 14, with a thin diaphragm 15 covering one end of said casing 14 where acoustic input is preferred. However, any hermetically sealed microphone could be adapted for said application.
The microphone casing 14 and electrode array 10 are connected to the housing sections 2 and 3 via junction 16 where cables 7 and 8 merge. Cables 7 and 8 (hereinafter referred to as connections 7 and 8) are each contain a plurality of biocompatible wires, preferably made of lithographically formed electro deposited platinum, where said wires are encapsulated in an inert polymer layer, such as the fluorocarbon FEP, where such polymer layer 17 is about 20-200 μm thick, preferably about 25-50 μm, where the cross-sectional area of each of said wire is about 0.0005-0.5 mm2 preferably about 0.01-0.05 mm2. For surgical convenience, said connections 7 and 8 are folded longitudinally (ie. pleated) to create 2-8 layers so as to minimize the cable width. Also, said connections 7 and 8 are preferably "corrugated" 17 over all or part of said connections so as to enable the connections 7 and 8 to expand with minimum stress during surgical handling, skull growth and any movement of the implanted components post surgery. Such corrugations 17, which are simply formed by first heating, then cooling, the polymer film in a corrugating jig, must be sufficient to allow for at least about 20-40 mm of expansion in each of the connections 7 and 8 to allow for normal skull growth from infant to adult. A review of other configurations that allow for subcutaneous stretching of wires due to growth is described in, for example, "Evaluation of Expandable Leadwires for Pediatric Cochlear Implants", by Shi-ang Xu, et. al., Amer. J. Otology, vol. 14, No. 2, March 1993.
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 piezoceramic 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.
Said housing sections 2 and 3 are both preferably substantially circular, both sections being thin and having a relatively rounded profile at the edges 11. The sections are joined by a pliable (or bendable) bridge 6.
The internal components within each housing section 2 and 3 are mounted on ceramic substrates 24 and 25, where such substrates are each approximately 50-500 μm thick, preferably about 250 μm, and where said substrates 24 and 25 contain a plurality of electrically insulated electrical lead-throughs. The underside of said ceramic substrates 24 and 25 are laminated to the polymer film 26 containing platinum wires. The underside of said film 26 is then laminated to a gold foil substrate 27, said gold foil 27 being approximately 25 μm to 250 μm thick, preferably about 50-75 μm thick, said foil 27 also forming the key support structure for the pliable bridge x.
Since said internal components are not all biocompatible, it is essential to hermetically encapsulate the internal components (mounted on the ceramic substrates 24 and 25) from ingress of body fluids and or leakage of component material into the body tissues, which can be partially accomplished using a medical grade epoxy. Said medical grade epoxy (or any biocompatible polymer) 28 is used to coat and encapsulate the internal components, but not the outside edges of the ceramic substrates 24 and 25, and excepting the gold (or platinum) foil over the snap domes 20 and 23, and excepting for the alternate embodiment, the surface of the PVDF piezo films. Of course, air or gas pockets 29 and 30 are required for operation of the snap domes 20 and 23. Additionally, air or gas pockets 29 and 30 are required for operation of the piezoceramics 19 and 22, where air or gas in all said pockets are slightly compressed during the action of the snap domes 20 and 23, and piezoceramics 19 and 22. Said epoxy 28 and 31 also provides a smooth shape to the external surface of housing sections 2 and 3. Alternately, any encapsulant material can be used as a substrate material to provide shape to the overall housing. The epoxy surfaces 28 and 31 are then covered, in one or more steps, with a layer of gold, preferably using well established vacuum deposition techniques, or alternatively, using electroless deposition, to create a thin layer of gold, about 0.01 μm to 10 μm thick, preferably about 0.1-1.0 μm thick. Said thin gold layer is subsequently thickened to about 10 μm to 500 μm, preferably about 25 μm to 75 μm, using established electro gold plating technology. Said gold layers are designed to bond directly to the outside edge of the ceramic substrates 24 and 25, thus creating a sealed, hermetic covering over the components mounted onto each of the ceramic substrates 24 and 25. Alternately, epoxy surfaces 28 and 31 are first covered, in one or more steps, with palladium using an electroless deposition process, and, in a further embodiment, thickened with gold. Other alternate embodiments include coating the outer gold layers with titanium (or platinum), and/or with medical grade silicone.
The gold or platinum (or, in the case of an all titanium or titanium/ceramic enclosure, titanium) foil over the snap domes 20 and 23 is pliable and thus beneficial for the manual operation, through the skin surface, of the underlying piezoceramics 19 and 22, so as to engage the panic "off/on" and volume "up" and volume "down" controls.
For the preferred embodiment, snap domes 20 and 23 are used for optimizing the operation of the piezoceramic actuators 19 and 22, where said actuators are each preferably mounted to a flexible support disc, 32 and 33. For a given pressure, said piezoceramic actuators 19 and 22 generate a much larger voltage spike when the snap domes 20 and 23 suddenly "snap" at a predetermined force when pushed, such action causing the piezoceramic material to very slightly bend (or flex) in a short time period thereby creating a substantially repeatable defined strong voltage pulse, said pulse being sufficient for activating the electronics. Also, the snap domes provide a convenient tactile feedback to the implantee indicating that the switch has been activated. Said snap domes are available from, for example, from Snaptron Inc., Loveland, Colo.
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.
The technology for implanting long-lasting secondary (ie. rechargeable) batteries, especially lithium type cells, in the human body is not well established. The key criteria are: (a) safety, (b) longevity and (c) charge capacity. Published studies have reviewed these issues (see for example, "Preliminary Evaluation of Rechargeable Lithium-ion Cells for an Implantable Battery Pack", by G. K. MacLean, et. al., J. of Power Sources 56 (1995) 69-74). The use of a primary cell is not practical for cochlear prostheses, since the power consumption is too high, being much higher than, for example, pacemakers. Although a number of rechargeable lithium type batteries are commercially available, they are generally not considered safe for implantation. The use of other battery chemistries, such as nickel metal hydride, is possible for implantation, albeit for only limited periods of time due to the limited number of charge/discharge cycles possible before said battery can no longer be effectively recharged. The preferred embodiment of the present invention uses a lithium chemistry battery developed by John Bates, et. al. of Oak Ridge National Labs, described in "Thin Film Rechargeable Lithium Batteries for Implantable Devices", ASAIO Journal, vol. 43, no. 5, 1997. Such a battery has high charge density, is substantially rechargeable over tens of thousands of cycles, and uses a solid state electrolyte, namely, lithium phosphorous oxynitride. Although such a battery meets the key criteria for a safe, long lasting rechargeable implantable battery, no data are as yet available with respect to long term implant usage.
With respect to the electronics, the preferred embodiment is an ultra low power analog circuit design, the basic theory of which is described in a Ph. D. Thesis by Walter Germanovix, October, 1998, Imperial College of Science, Technology and Medicine, University of London, U.K., to process the speech signals from the microphone to electric current signals to be sent to the electrode array 10. An alternate embodiment uses a more conventional DSP design in a relatively compact package, although such a design requires more power and space to operate than the analog design.
The electronics for the battery charger circuit and other controls use established technology.
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.
An alternate embodiment involves having the surgeon recess one or both housing sections 2 and 3 in a small excavation of the outer plate of the skull, or against the dura in an infant, or even between the dura and the skull in a small infant. As the invention has no external behind-the-ear speech processor (as in some of the current commercial devices) the housing sections 2 and 3 do not have to be placed more than about 4.5 cm behind the postauricular skin crease to avoid conflict with a behind-the-ear mounted device. In fact, the housing sections 2 and 3 can be placed as close to the skin crease as the surgeon wishes. These factors offer a significant reduction in the surgical time compared to that now required for implanting conventional cochlear devices. There is also less anesthetic time needed, and in view of the lesser dissection, a quicker healing process from the surgical intervention is expected. Such modified surgical procedure also allows for implantation using only local anesthesia, and would be especially suitable for young infants, or the elderly, or those with other disabilities who cannot tolerate extensive surgery or general anesthesia, thus extending the range of persons that can be implanted using the invention, and reducing surgical cost and risk.
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.
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.
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.
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.
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.
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.
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.
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. 10 and/or 11.
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.
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.
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.
The above descriptions have been intended to illustrate the preferred and alternative embodiments of the invention. It will be appreciated that modifications and adaptations to such embodiments may be practiced without departing from the scope of the invention, such scope being most properly defined by reference to this specification as a whole and to the following claims.
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|U.S. Classification
|623/10, 607/57, 600/25
|International Classification
|Cooperative Classification
|European Classification
|Apr 2, 2007
Owner name: MED-EL ELEKTRO-MEDIZINISCHE GERATE GESELLSCHAFT M.
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:EPIC BIOSONICS INC.;REEL/FRAME:019102/0276
Effective date: 20061227
|May 18, 2007
|Fee payment
Year of fee payment: 4
|Apr 20, 2011
|Fee payment
Year of fee payment: 8
|May 12, 2015
|Fee payment
Year of fee payment: 12


text:
Register and Join the most happening forum of Sikh community & intellectuals from around the world.
YES..I see Him Daily and interact with HIM all the time...He is in the Japji..the Vaar Asa, Oankaar..etc etc etc...Loud and clear...as LIVING...
Oh well another heated debate with family. I am not listening to enough Shabads! Apparently I should stop listening to that heavy...
Patna Sahib Jathedar not invited to meeting of Sikh high priests
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Tribune News Service
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subset: commoncrawl


text:
Grasshopper Jungle Trailer (2016)
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Talampanel for Amyotrophic Lateral Sclerosis (ALS) (ALS)
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|Drug: Talampanel Other: placebo
|Phase 2
|Study Type:
|Study Design:
|Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:
|A Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Tolerability and Safety of Talampanel in Subjects With Amyotrophic Lateral Sclerosis (ALS)
- Change in ALS Functional Rating Score (ALSFRS-R slope) [ Time Frame: 52 weeks ]
- Time from baseline to the first occurrence of either death, tracheostomy or permanent assisted ventilation. [ Time Frame: 52 weeks ]
|Study Start Date:
|September 2008
|Study Completion Date:
|May 2010
|Primary Completion Date:
|April 2010 (Final data collection date for primary outcome measure)
|Assigned Interventions
Experimental: Talampanel 50mg
50mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist
Experimental: Talampanel 25mg
25mg Talampanel 3 times per day
Drug: Talampanel
capsules Talampanel, 3 times per day, 52 weeks
Other Name: AMPA antagonist
Placebo Comparator: Placebo
placebo 3 times per day
Other: placebo
capsules, placebo, 3 times a day, for 52 weeks
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:
|18 Years to 80 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Subjects with sporadic or familial ALS classified as definite, probable, or laboratory-supported probable ALS according to the revised El Escorial criteria.
Inclusion Criteria:
- Diagnosis of definite or probable ALS in accordance with the El-Escorial criteria.
- Subject has experienced his/her first ALS symptoms within 3 years prior to the screening visit.
- Slow VC test equal to or greater than 70% of the predicted value.
- The sum of the 3 respiratory items on the ALSFRS-R must total at least 10 points.
- Subjects taking riluzole must be on a stable dose for at least 8 weeks prior to screening visit.
- Ages 18-80 (inclusive)
Exclusion Criteria:
- The use of invasive or non-invasive ventilation.
- Subject having undergone gastrostomy.
- Subject with any clinically significant or unstable medical condition.
- Subject participating in any other investigational drug trial or using investigational drug (within 12 weeks prior to screening and thereafter).
- Females who are pregnant or nursing.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696332
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696332
Hide Study Locations
|United States, California
|CA Medical Center for Movement Disorders-Forbes Norris MDA/ALS Research Center
|San Francisco, California, United States, 94115
|United States, Kansas
|University of Kansas Medical Center - Dept of Neurology
|Kansas City, Kansas, United States, 66160
|United States, Maryland
|Johns Hopkins OPC - Meyer Bldg
|Baltimore, Maryland, United States, 21287
|United States, Massachusetts
|Massachusetts General Hospital-Neurology Clinical Trials Unit
|Charlestown, Massachusetts, United States, 02129
|United States, Minnesota
|Mayo Clinic
|Rochester, Minnesota, United States, 55905
|United States, New York
|Columbia University - Neurology Institute
|New York, New York, United States, 10032
|SUNY Upstate Medical University
|Syracuse, New York, United States, 13210
|Academic Hospital University of Leuven - ALS dept
|Leuven, Belgium, B-3000
|Canada, British Columbia
|ALS Centre
|Vancouver, British Columbia, Canada, V5Z 2G9
|Canada, Ontario
|London Health Sciences Centre Motor Neuro Diseases Clinic
|London, Ontario, Canada, N6A 5A5
|Canada, Quebec
|Montreal Neurological Institute
|Montreal, Quebec, Canada, H3A 2B4
|C.H.U. La Timone - Service de Neurologie
|Marseille Cedex 5, France, 13385
|C.H.U. de Montpellier - Hopital Gui de Chauliac - Service des Explorations Neurologiques
|Montpellier Cedex 5, France, 34295
|Hopital La Pitie Salpetriere - Federation de Neurologie
|Paris, France, 75013
|Universitaetsklinik Berlin-Charite, Campus Virchow Klinikum, Neurologische Klinik
|Berlin, Germany, 13353
|Berufsgenossenschaftliche Klinik Bergmannsheil, Neurologische Klinik
|Bochum, Germany, 44789
|Universitaet Ulm
|Ulm, Germany, 89081
|Semmelweis University, Department of Neurology
|Budapest, Hungary, 1083
|Sourasky MC -EMG Unit
|Tel Aviv, Israel, 64239
|Fondazione "S.Maugeri" Clinica della Riabilitazione IRCCS-Istituto Scientifico di Lissone
|Lissone (MI), Italy, 20035
|Centro Clinico NEMO
|Milano, Italy, 20162
|Azienda Ospedaliero Universitaria San Giovanni Battista di Torino - Dipartimento di Neuroscienze
|Torino, Italy, 10126
|Universitair Medisch Centrum Utrecht
|Utrecht, Netherlands, 3584 CX
|Hospital Carlos III
|Madrid, Spain, 28029
|Responsible Party:
|Teva Pharmaceutical Industries
|ClinicalTrials.gov Identifier:
|NCT00696332 History of Changes
|Other Study ID Numbers:
|First Submitted:
|June 10, 2008
|First Posted:
|June 12, 2008
|Last Update Posted:
|October 21, 2011
|Last Verified:
|October 2011
Keywords provided by Teva Pharmaceutical Industries:
Additional relevant MeSH terms:
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases


text:
The Current State of Stocks w/ Kevin Logan, Managing Partner at Occasio Partners
In this week's podcast, Marc talks to seasoned trader and Managing Partner at Occasio Partners, Kevin Logan, about the current state of the markets. Kevin explains why he believes a quick rise in interest rates is "something this economy can't handle" and why bonds and stocks moving down together is a bad sign. Later, Marc dips into the mailbag and responds to a listener question about dividend-paying mutual funds.


text: As much as I'm sure this pains most of us, it's just pointless to hope the Reds do things like the As. It's never going to happen. This is a team that just spent huge amounts of money on a closer and a manager, and that manager thinks baserunners clog the bases. They're sort of like the Anti-As; maybe we should start calling them the Cincinnati Zs?


text:
My Nonprofit Reviews
Vivien L.
Review for Be The Star You Are Inc, Moraga, CA, USA
I have been a volunteer with Be The Star You Are since 9th grade, and I love to incorporate my love of reading into a service for the community. This organization truly promotes the importance of literacy, giving and self-motivation. I am so grateful to be a member of this charity, and I absolutely love working with Cynthia!
More Feedback
I've personally experienced the results of this organization in...
bringing light to important issues, and in promoting strength in women, family, and teenagers!
If I had to make changes to this organization, I would...
branch out further and spread our message so that more people can be aware of our messages and actions.
Thanks Vivien for your enthusiasm and interest in always learning new things. You are terrific!


text:
DLA Piper partners" />
DLA Piper commercial litigation partners Damian Crosse and James Haddleton have left the firm.
Crosse, the firm's Leeds head of commercial litigation, quit DLA Piper this month and is set to join Pinsent Masons.
Haddleton left the firm's Leeds office on Friday (25 January) to join the local branch of North West insurance specialist DWF. Haddleton said: "In Leeds, DWF is already turning heads and becoming the natural alternative to the six largest firms in the city."
Crosse and Haddleton are the latest in a series of partners to leave DLA Piper's regional offices recently.
DLA Piper chief executive Nigel Knowles said: "We've made up a record number of partners. We continue to attract and admit quality laterals. Any suggestion that there's a mass exodus from DLA Piper is fantasy."
As reported by The Lawyer (14 January), Halliwells hired former Sheffield head of corporate Neil Thompson as part of an ongoing assault on its larger rival, which has included partners Beverley Bentley, Jonathan Brown, Richard Capper, Colin Gibbons, Paul Jefferson, Fiona Parry and Craig Scott in recent months.
Former head of property litigation at DLA Piper's Liverpool office Kevin Lee also moved to Halliwells towards the end of last year.
Crosse's hire marks the second recent raid on the firm by Pinsents. The firm made four appointments in December to ramp up its global projects and UK project finance groups.
Meanwhile, DLA Piper's Scottish office has raided two rivals to secure two partners. Associates Keith Dinsmore and Scott Thiel joined from Dickson Minto and Dundas & Wilson respectively and have stepped up to partner level.
Dinsmore will join DLA Piper's corporate group, while Thiel has joined the technology, media and commercial department.


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Sichuan Dou Hua Restaurant80 Raffles Place, #60-01 UOB Plaza 1Singapore, Singapore
Driving Directions:Raffles Place MRT
Lunch will take place at the Sichuan Dou Hua Restaurant, at UOB Plaza at Raffles Place. We have a special price of S$98 for early-birds so register now through our eventbrite link!
Ticket for Early Bird (UOC Alumnus, Members of DUAL and family) = SGD98/-
Tickets for Adults = SGD 118/-
Tickets for Children ( 6-12 ) = SGD 88/- Tickets for Children (0-5) = FOC
Register OnlineRegister By Email
Deadline: 2/10/2011
Gary Kwang '09, '09 9455 6978
The University of Chicago Booth School of Business |
University of Chicago |
Privacy Policy


text:
this piano solo is awesome:
check it out. i just got the sheet music for it. im gonna be workin on it.
this piano solo is awesome:
check it out. i just got the sheet music for it. im gonna be workin on it.
My Website
"Circular logic is good because it is."
freakin sweet. will have to check them out some more.
Some music rubbish by me.
Anyway, yeah it's really cool but there are some crap parts.
Anyway, kewl d00d
Last edited by Felix; 11-24-2003 at 11:54 AM.
Rots Soft
If the facts don't fit the theory, change the facts.
Albert Einstein (1879 - 1955)
Cool! It's by Jon Schmidt. I downloaded the sheet music for "All of Me" awhiles back and it's really fun to play.
I'm gonna check this one out too. Can you give me a direct link to the Waterfall sheet music? Or is it one of his songs you have to pay for?
Last edited by Cshot; 11-25-2003 at 05:43 PM.
Try not.
Do or do not.
There is no try.
- Master Yoda
Heh, I've had that one for years on a burned CD. Good to know that other people think it's as fun as I do.
My best code is written with the delete key.


text:
Dobro Classics Plus - 2nd Edition
By Steve Toth
20 Classic and Original Tunes. By Steve Toth. Fretted. Softcover with CD. With guitar tablature. Published by Centerstream Publications (HL.187).
Item Number: HL.187
ISBN 1574240226. 9x12 inches.
Now with CD! A collection of 20 classic Dobro tunes likely to come up in jam sessions, incorporating the sounds and styles developed by the masters. Focuses primarily on up-tempo tunes, with 5 of Steve Toth's original instrumentals. Includes: Bill Cheatham • Blackberry Blossom • Gold Rush • Greensleeves • Katy Hill • Red Haired Boy • Sally Ann • Sally Goodin • Salt Creek • Sometimes Alone • Southwind • and more. Includes an explanation of tablature.


text: I went to BB yesterday to pick up Black Hawk Down and was floored when I found a "A Bugs Life" too. I thought Disney had already "Put it in the Vault" because I had never seen the DVD in any store before. I was so excited to get it for my 2 year old that I didn't notice that it had no cellophane on it. Well, I got it home and the F-ing case was empty! My bad for not being observant. So, will BB give me grief if I try to exchange it? It's going to sound like a crock when I walk in there. Anyone have an experience like this before? Ralph


text:
Trova una copia in biblioteca
Stiamo ricercando le biblioteche che possiedono questo documento…
|Persona incaricata:
|Clarence Thomas; Clarence Thomas
|Tipo materiale:
|Biography, Pubblico giovane, Risorsa internet
|Tipo documento
|Libro, Risorsa Internet
|Tutti gli autori / Collaboratori:
Kevin Merida; Michael A Fletcher
|9780385510806 0385510802
|Numero OCLC:
|Black Caucus of the American Library Association Literary Award, 2008.
|viii, 422 pages : illustrations ; 25 cm
|Courting venom : being Clarence Thomas --
The Pin Point myth --
The Savannah reality --
Myers, Leola, and Emma --
"Radical" times --
The making of a conservative --
Meteoric rise --
Who lied? --
The aftermath : Thomas's love affair with the right --
Cruel and unusual punishment --
Marshall's footprints --
Inside the court --
Silent justice --
Scalia's clone? --
The quiet, anonymous life --
|Kevin Merida and Michael A. Fletcher.
|Maggiori informazioni
Tracks the personal odyssey of perhaps the least understood man in Washington, from his poor childhood in Pin Point and Savannah, Georgia, to his educational experiences in a Catholic seminary and Holy Cross, to his law school years at Yale during the Black Power era, to his rise within the Republican political establishment. It offers a window into a man who straddles two different worlds and is uneasy in both--and whose divided personality and conservative political philosophy will deeply influence American life for years to come. This book originated from a profile of Clarence Thomas that appeared in The Washington Post Magazine. In it, Merida and Fletcher, both Post staffers, both black, crafted a haunting portrait of an isolated and bitter man, savagely reviled by much of the black community yet not entirely comfortable in white society.--From publisher description.
Commenti degli utenti
Documenti simili
- Thomas, Clarence, -- 1948-
- United States. -- Supreme Court -- Officials and employees -- Biography.
- United States. -- Supreme Court.
- USA -- Oberster Gerichtshof.
- Judges -- United States -- Biography.
- African American judges -- Biography.
- African American judges.
- Employees.
- Judges.
- United States.
- Richter.
- Schwarze.


text:
Comprehensive page of helpful links for parents, teachers, students, and others; whether you are looking for educational, fun, or teaching tips and/or ideas.
Center for Innovations in Education
DASA - Disabled Athlete Sport Association
Missouri Planning Council for Developmental Disabilities
Missouri Protection &Advocacy Services
Pediatric Neurosurgery at St. Louis Children's Hospital and Washington University School of Medicine
Shriners Hospital for Children - St. Louis
St. Louis Wheelchair Athletic Association
UMKC Unstitue for Human Development, UCEDD
DRM Regional Resources Directory
Illinois Spina Bifida Chapter (ISBA)
Illinois Provider Directory for Children with Special Health Care Needs & Their Families
Illinois Yellow Pages for Kids with Disabilities
National Sports Center for the Disabled
"If your family is welcoming a new baby born with Spina Bifida, or if you have been told that your unborn child has Spina Bifida, you probably have many questions and concerns, as do your extended family, friends, and neighbors. We have written this information keeping in mind our own diverse experiences when our children were born with Spina Bifida". Welcoming Babies with Spina Bifida By Linda Rowley click here
American Syringomyelia Alliance Project, Inc ASAP
Brain Awareness Week at Washington University
Decreasing the Chance of Birth Defects
Fetal Surgery for Spina Bifida
International federation for hydrocephalus & spina bifida (if)
National Birth Defects Prevention Network
National Dissemination Center for Children with Disabilities (NICHCY)
National Council on Folic Acid (NCFA)
National Library of Medicine - National Institutes of Health
NINDS Chiari Malformation Information Page
Special Needs Project -- a unique disability bookstore
World Arnold Chiari Malformation Association
The St. Louis County Police Department list on sex offenders http://www.co.st-louis.mo.us/police/sexoffenders.html
The Illinois State Police provides an online listing of sex offenders required to register in the State of Illinois. http://www.isp.state.il.us/sor/frames.htm
KEEPING OUR CHILDREN SAFE - Polly Klaas Foundation http://www.pollyklaas.org/safe/index.htm


text:
- Home
- Artwork Requirements
Artwork Requirements
Images should be high resolution at 300dpi or greater.
Vector format file (EPS, Adobe Illustrator, PDF) is preferred. Make sure all text is saved to curves. PC formats (TIF, BMP, JPEG, Corel Draw) are acceptable.
Word Document
Artwork embedded within a Word document is generally low resolution and will appear pixilated when engraving.
Color Logos are available on Plaques and SOME desk items. Check the availability when working on an order.
Usability is determined on a case by case basis. Photo, grey scale, halfones can be difficult to reproduce on engraved /etched items.


text:
Eugene, Oregon (PressExposure) February 12, 2009 -- IDX, Inc. is excited for the addition of Deva Ossig with Weichert Realtors, to the ever expanding amount of real estate professionals opting to add innovative IDX Broker software to their websites, in order to provide their clients with a much more simple and efficient way to search for real estate on the web. Residing in Wayne, Pennsylvania, Ossig is a member of the Trend MLS (Trend). Clients of Ossig living in Wayne and its surrounding areas can now browse thousands of property listings, provided by Trend, all without ever being directed away from her website. The Internet Data Exchange (IDX) software extracts raw property listing data from Trend and arranges it to be displayed as an integration division of Ossig's site.
With the help of custom IDX Broker software, Ossig has the ability to control the entire look of her website, as well as decided which search categories she wants to be displayed to her clients. Whether they want to browse through the basic search, advanced or custom search, map search, address search or listing ID search, potential home buyers will have numerous options to help narrow down their results, in efforts to find their ideal home. By simply clicking on one of the search category links, clients will have access to contacting the listing agent for more information, schedule a showing, print a flyer, pinpoint the property on an interactive map, email about property information, and even calculate likely mortgage payments.
During the clients real estate quest, they have the option of saving their detailed search criteria, in which Ossig has access to, via an administrative login dashboard. Ossig can then take this information to get to know her clients on a more personal level, and in turn help them to find their ideal property in a quick, efficient and hassle free manner. This login in feature also gives Ossig the option to edit her custom CSS and global wrappers, as well as keep track of which pages on her site are being viewed most frequently, through a detailed traffic report. All of these features can be used to Ossig's advantage, and help her to manage her business on a more personalized level.
About Deva Ossig Deva Ossig is a real estate professional, residing in Wayne, Pennsylvania. She is an outstanding realtor and proud to be a member of the Weichery Realtors team. "Weichert has grown from a single office into one of the nation's leading providers of homeownership services by putting customers first. To begin with, we've turned Weichert sales offices into true "one-stop" destinations for the full range of real estate products and services. Now, there's always an expert on hand to offer solutions and advice on mortgages, insurance, and all the details of moving. Weichert has nearly 18,000 sales associates in more than 500 company-owned and franchised sales offices in key markets throughout the U.S."


text:
Weight Trailer (2011)
15 October 2011 Drama, Foreign
Stept Productions worked with The North Face and K2 Skis, to bring you a ski film that captures the new movement in skiing. Skiers explore the streets of Boston and Chicago in search of the biggest rails in the world, while running into some inspiring characters along the way. When the cities dry out, the weight is lifted, and the crew finds themselves skiing neck deep powder, and pushing the limits of jumping.
Watch the official Weight 2011 trailer in HD below or find more Weight videos on Vidimovie.


text:
Father's Day is around the corner. If you're anything like me, you may be wondering what to get Dad. My father no longer wears ties to work– so that's out–and probably has three "back-up" wallets I've given him over the last several years. So, maybe this year is the year to give him something for his fitness. Here are some suggestions:
A pedometer. Walking has so many benefits. Studies have shown it to be useful for people with chronic conditions from osteoporosis to heart disease. Keeping track of steps can be a motivator to get out and get healthy while enjoying the spring weather. As we begin to face the warmer, more humid summer weather, walking is still a beneficial activity but may need to be done at a gym or other indoor, climate-controlled space.
A heart rate monitor or app. In the healthy population over age 65, the minimum recommended amount of cardiovascular activity is 30 minutes of moderate-intensity aerobic activity performed five days a week. It is also okay for the older adult to break up the allotted time into shorter sessions throughout the day. Taking a 10-minute walk, three times a day may be more manageable and a great starting point.
Monitoring heart rate can be a useful tool to gauge exertion. (Keep in mind that certain medications, like beta blockers, can blunt the heart rate response to exercise, making a perceived exertion scale a more practical choice. The Borg scale, for example, would be more useful but may be a less-than-exciting gift idea.)
Free weights or resistance bands. There is something to be said about the whole "use it or lose it" adage. Strength training is particularly important in the osteoporotic population; however, it needs to be increased gradually and performed correctly to avoid increasing the risk of fracture.
When it comes to strength training for the older adult, the recommendation is to increase resistance to a point where a person is able to lift a given weight eight times. When able to comfortably complete a set of 10-15 repetitions, it is time to increase the resistance.
Tai Chi DVD or class card. Balance training has been found to prevent falls and reduce the risk of injury with falling. Classes in a group setting can be a helpful way of challenging the balance while engaging in a social context. If Tai Chi isn't an exciting option, feel free to think outside the box. My parents recently took up ballroom dancing. What a great way to build balance, improve coordination, and get to problem solve as a team!
(Warning: I have become a bystander for discussions as to whether you're supposed to step with the left foot on count two or three...And who exactly is supposed to be leading?)
Stretch strap. Flexibility training is another key component to an activity plan for the young-at-heart adult. It is recommended that stretches last 10-30 seconds and be performed at least twice a week. The stretch should be completed without pain or over-stretching. In my practice, I have found a stretch strap to be useful to achieve a muscle stretch without over-stressing joints or the low back.
As with any age group, something is better than nothing. If a person is unable to meet the recommended amount of activity due to a decline in health status, it is still beneficial to do as much exercise as tolerated. A doctor should help set guidelines for activity to safely initiate a new exercise program. Start small and progress gradually to ensure success. It is also never too late to start moving. So get moving on that perfect fitness-related gift for Dad.
Jennifer Zellers, P.T., D.P.T., received her degree from Columbia University and is an advanced clinician at Thomas Jefferson University Hospital.
Read more Sports Doc for Sports Medicine and Fitness.


text:
Amazon Echo & Echo Dot now up for pre-order in the UK. Echo discounted £99 for Prime members.
Amazon have finally announced they are launching the Echo in the UK, and the RRP will be £149.99...Read More
by James | Sep 15, 2016 | Amazon, Home Automation, Speakers | 0 |
Amazon have finally announced they are launching the Echo in the UK, and the RRP will be £149.99...Read More
I love my Sonos in the Kitchen, it is great just to be able to click play and it immediately...Read More
by skin | Nov 14, 2010 | Android, Hardware, Laptops & Notebooks | 0 |
Continuing with the tablet updates from last week, Toshiba recently released the FOLIO 100 on our shores as it's iPad beater. The price is reasonable at £329 so if you're looking for a good Christmas present this could be one...Read More
Sick of feeding the pockets of the Apple Monster, or want to start paying for your "downloads" so not to be breaking the law. Well UK high street entertainment chain HMV have re-launched it's digital service(yes they've had one...Read More
by James | May 28, 2009 | Android, Phones, Tablets, & Phablets, Spotify | 0 |
Spotify is absolutely huge in the UK at the moment and the release of a mobile application is inevitable. It is almost a given that Spotify will release on the iPhone however it appears that Android has beaten the iPhone in...Read More


text:
JD's Bar & Grill Peterborough, Cambridgeshire
JD's Bar & Grill, Peterborough! Great food, drinks and atmosphere in the city centre! Description Welcome to JD's Bar & Grill, Peterborough! Situated on Park Road in the city centre JD's is THE place to be if you are a fan of great food, superb drinks selection, value for money offers and good vibes! Bright, vibrant & modern - JD's offers a relaxed and informal dining experience that's backed up by an innovative, diverse and exciting menu providing you with the perfect excuse to pop in read more


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Buy Nokia Mobile Phones Online at Snapdeal
Today, it is hard to imagine life without a mobile phone. Whether you require a feature-rich smartphone or a simple feature phone, choose the right one for you from the extensive range of Nokia mobile phones available at Snapdeal.
Shop Online for Nokia Mobiles
A trusted mobile phone brand, Nokia phones are not only stylish but also highly utilitarian. Both Nokia smartphones and Nokia feature phones are equipped with powerful batteries, so you do not have to worry about missing calls or messages due to low battery. Nokia phones also have either have rear cameras or rear and front cameras both. Thus, you can click pictures and record videos whenever you please. Designed to last, a Nokia Windows phone or a Nokia Android mobile will allow you to stay connected round the clock.
Nokia Feature Phones
If you are not comfortable using a touchscreen phone and have no real need for a smartphone, opt for a Nokia feature phone. Available in a bar shape, most feature phones are phones that do not have touchscreens. Easy to operate, feature phones have a display screen with a keypad placed just below it. Many of these feature phones also have a dual SIM feature which makes them extremely useful. Compact in size and extremely lightweight, feature phones can easily be slipped into one's pocket or one's handbag. The phones that have rear cameras let you take pictures and record videos as well. True to their name, feature phones have multiple useful features like an FM radio, Bluetooth, a music player, an alarm and many more.
Nokia Smartphones
Smartphones have become a way of life for people who like to stay connected 24x7, on the go. Whether it is entertainment or work, a Nokia smartphone will make your life easier. These smartphones have big screens with high resolutions that ensure the best possible picture quality. The powerful and fast processors ensure that you can multi-task without the phone slowing down. Many of these phones have dual cameras too. A benefit of the secondary camera is that it allows you to click any number of selfies you wish to. Most Nokia smartphones, like the ones in the Lumia series, run on the Windows operating system. However, if you prefer the Android OS, Snapdeal offers some Nokia phones that run on the Android operating system.
Nokia offers a manufacturer's warranty on their products, so after-sales support is not something you need to worry about. Check Nokia mobile price browsing through the collection of Nokia mobile phones offered here. Buy Nokia mobiles online from Snapdeal right away.
Indulge the online shopping experience on tablet, to buy Memory cards & Pen Drives from Snapdeal.com - one of the best online shopping site in India.. Check for prices of 2GB, 4GB, 8GB, 16GB, 32GB, 64GB, 128GB & 256GB SD Cards, Micro SD Cards, Class 10 Memory cards & Pen Drives online.


text:
I Revisited Satyajit Ray's 'Apu Trilogy' And Here's What I Discovered
Repeat viewings also create new associations. Now, for me the Apu Trilogy is also about springtime in New York.
Get top stories and blog posts emailed to me each day. Newsletters may offer personalized content or advertisements. Learn more