EP4669414A1 - ELECTRODE ARRANGEMENT WITH SURFACE CHARACTERISTICS - Google Patents

ELECTRODE ARRANGEMENT WITH SURFACE CHARACTERISTICS

Info

Publication number
EP4669414A1
EP4669414A1 EP24759838.6A EP24759838A EP4669414A1 EP 4669414 A1 EP4669414 A1 EP 4669414A1 EP 24759838 A EP24759838 A EP 24759838A EP 4669414 A1 EP4669414 A1 EP 4669414A1
Authority
EP
European Patent Office
Prior art keywords
carrier member
assembly
electrode
protrusion
section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24759838.6A
Other languages
German (de)
French (fr)
Inventor
Peter Raymond Sibary
Andrian SUE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Cochlear Ltd
Original Assignee
Cochlear Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cochlear Ltd filed Critical Cochlear Ltd
Publication of EP4669414A1 publication Critical patent/EP4669414A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0529Electrodes for brain stimulation
    • A61N1/0534Electrodes for deep brain stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0541Cochlear electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0526Head electrodes
    • A61N1/0543Retinal electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • A61N1/36038Cochlear stimulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/36078Inducing or controlling sleep or relaxation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36046Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the eye

Definitions

  • Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades.
  • Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component).
  • Medical devices such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
  • implantable medical devices now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
  • an apparatus comprising a plurality of electrodes, an electrode carrier member and a raised area on an outside of the carrier member, wherein the apparatus is a cochlear implant electrode array, the plurality of electrodes are arrayed in a longitudinal direction of the cochlear implant electrode array, and the raised area extends in the longitudinal direction contiguous with at least two electrodes.
  • an assembly comprising a plurality of electrode contacts, an electrode carrier member; and a protrusion extending about at least two of the plurality of electrode contacts on an outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
  • an assembly comprising an electrode contact, electrode carrier member and a protrusion on an outside of the carrier member forming at least a portion of an arrangement that bounds an area on an outer surface of the carrier member on an opposite side from the electrode contact, wherein the assembly is an implantable stimulating assembly.
  • FIG. 1A is a perspective view of an exemplary hearing prosthesis in which at least some of the teachings detailed herein are applicable;
  • FIGs. 1B-1D are quasi functional diagrams of an exemplary device to which some embodiments may be applicable;
  • FIGs IE and 2A and 2B and 2C and IF present some schematics related to base technologies associated with some embodiments
  • FIGs. 3 and 4 show other exemplary medical devices to which at least some of the teachings herein are applicable;
  • FIG. 5 shows a top view of an exemplary implantable portion of a cochlear implant according to an embodiment
  • FIGs. 6A-6I show features associated with an electrode array
  • FIGs. 7A and 7B show how an array can curl in some embodiments
  • FIGs. 8-10 show side views of an electrode array
  • FIGs. 11-19A show exemplary cross-sections of an electrode array
  • FIGs. 20-25 show top views of exemplary electrode arrays
  • FIG. 26 is a cross-section of an array
  • FIG. 27 is a cross-section of an array
  • FIG. 28 is a flowchart for an exemplary method
  • FIGs. 29-31 and 33 show exemplary mould features
  • FIG. 32 shows a top view of a modified electrode array.
  • the techniques presented herein are primarily described herein with reference to an illustrative medical device, namely a hearing prosthesis.
  • a cochlear implant First introduced is a cochlear implant.
  • the techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from the teachings herein used in other medical devices.
  • any techniques presented herein described for one type of hearing prosthesis corresponds to a disclosure of another embodiment of using such teaching with, at least in conjunction with, another hearing prosthesis, including bone conduction devices (percutaneous, active transcutaneous and/or passive transcutaneous), middle ear auditory prostheses, direct acoustic stimulators, and also utilizing such with other electrically simulating auditory prostheses (e.g., auditory brain stimulators), etc.
  • the techniques presented herein can be used with implantable / implanted microphones, whether or not used as part of a hearing prosthesis (e.g., a body noise or other monitor, whether or not it is part of a hearing prosthesis) and/or external microphones.
  • vestibular devices e.g., vestibular implants
  • seizure devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • sleep apnea devices e.g., devices for monitoring and/or treating epileptic events, where applicable
  • embodiments include the application of the teachings herein to a medical device that is a non-implanted medical device, such as a minimally invasive probe used by medical personnel.
  • any of the technologies detailed herein which are associated with components that are implanted in a recipient can be combined with information delivery technologies disclosed herein, such as for example, devices that evoke a hearing percept, to convey information to the recipient.
  • information delivery technologies disclosed herein such as for example, devices that evoke a hearing percept
  • a sleep apnea implanted device can be combined with a device that can evoke a hearing percept so as to provide information to a recipient, such as status information, etc.
  • the various sensors detailed herein and the various output devices detailed herein can be combined with such a non-sensory prosthesis or any other nonsensory prosthesis that includes implantable components so as to enable a user interface, as will be described herein, that enables information to be conveyed to the recipient, which information is associated with the implant.
  • any disclosure herein with respect to a hearing prosthesis corresponds to a disclosure of another embodiment of utilizing the associated teachings with respect to any of the other prostheses noted herein, whether a species of a hearing prosthesis, or a species of a sensory prosthesis.
  • the techniques presented herein are also described with reference by way of background to another illustrative medical device, namely a retinal implant.
  • the techniques presented herein are also applicable to the technology of vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), as well as sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation, etc.
  • FIG. 1A is perspective view of an implantable portion of a cochlear implant 100, implanted in a recipient.
  • the implantable portion of the cochlear implant 100 is part of a partially implantable cochlear implant system 10 that can include external component s), as will be detailed below.
  • the recipient has an outer ear 101, a middle ear 105, and an inner ear 107.
  • Components of outer ear 101, middle ear 105, and inner ear 107 are described below, followed by a description of implant 100.
  • outer ear 101 comprises an auricle 110 and an ear canal 102.
  • An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102.
  • a tympanic membrane 104 Disposed across the distal end of ear canal 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111.
  • Bones 108, 109, and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to vibration of tympanic membrane 104.
  • This vibration sets up waves of fluid motion of the perilymph within cochlea 140.
  • Such fluid motion activates tiny hair cells (not shown) inside of cochlea 140.
  • Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.
  • implantable portion of cochlear implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient.
  • Implant 100 is shown in FIG. 1A with an external device 142, that is part of system 10 (along with implantable portion of the cochlear implant 100), which, as described below, is configured to provide power to the implant.
  • external device 142 may comprise a power source (not shown) disposed in a Behind-The-Ear (BTE) unit 126.
  • External device 142 also includes components of a transcutaneous energy transfer link, referred to as an external energy transfer assembly.
  • the transcutaneous energy transfer link is used to transfer power and/or data to implant 100.
  • Various types of energy transfer such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and/or data from external device 142 to implant 100.
  • the external energy transfer assembly comprises an external coil 130 that forms part of an inductive radio communication link.
  • External coil 130 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire.
  • External device 142 also includes a magnet (not shown) positioned within the turns of wire of external coil 130. It should be appreciated that the external device shown in FIG. 1A is merely illustrative, and other external devices may be used with embodiments of the present invention.
  • Implantable portion of the cochlear implant 100 comprises an internal energy transfer assembly 132 which may be positioned in a recess of the temporal bone adjacent auricle 110 of the recipient.
  • internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and/or data from external device 142.
  • the energy transfer link comprises an inductive RF link
  • internal energy transfer assembly 132 comprises a primary internal coil 136.
  • Internal coil 136 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire.
  • the implantable portion of the cochlear implant 100 further comprises a main implantable component 120 and an elongate stimulating assembly 118.
  • internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing.
  • main implantable component 120 includes a sound processing unit (not shown) to convert the sound signals received by the implantable microphone in internal energy transfer assembly 132 to data signals.
  • Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate stimulating assembly 118.
  • Stimulating assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, disposed along a length thereof.
  • a stimulator unit generates stimulation signals which are applied by stimulating contacts 148, which, in an exemplary embodiment, are electrodes, to cochlea 140, thereby stimulating auditory nerve 114.
  • stimulation contacts can be any type of component that stimulates the cochlea (e.g., mechanical components, such as piezoelectric devices that move or vibrate, thus stimulating the cochlea (e.g., by inducing movement of the fluid in the cochlea), electrodes that apply current to the cochlea, etc.).
  • the teachings detailed herein and/or variations thereof can be utilized with a totally implantable prosthesis. That is, in an alternate embodiment of the cochlear implants or other hearing prostheses detailed herein, the prostheses are totally implantable prostheses, such as where there is an implanted microphone and sound processor and battery.
  • FIG. IB provides a schematic of an exemplary conceptual sleep apnea system 1991.
  • this exemplary sleep apnea system utilizes a microphone 12 (represented conceptually) to capture a person’s breathing or otherwise the sounds made by a person while sleeping.
  • the microphone transduces the captured sound into an electrical signal which is provided via electrical leads 198 to the main unit 197, which includes a processor unit that can evaluate the signal from leads 198 or, in another arrangement, unit 197 is configured to provide that signal to a remote processing location via the Internet or the like, where the signal was evaluated.
  • the unit 197 activates to implement sleep apnea countermeasures, which countermeasures are conducted by a hose 1902 sleep apnea mask 195.
  • sleep apnea countermeasures By way of example only and not by way of limitation, pressure variations can be used to treat the sleep apnea upon an indication of such an occurrence.
  • the advanced implantation methods and devices detailed herein can be utilized to treat sleep apnea / in a device that can be used to treat.
  • the electrodes of the implant disclosed below can be utilized in place of the electrodes 194 (placed accordingly, of course), and the implant can be of a configuration to treat sleep apnea.
  • the implantable components detailed herein can be located at locations to treat sleep apnea in accordance with the teachings herein, with the requisite modification if necessary or otherwise utilitarian to implement such.
  • FIGs. 1C and ID provide another exemplary schematic of another exemplary conceptual sleep apnea system 1992.
  • the sleep apnea system is different from that of figure IB in that electrodes 194 (which can be implanted in some embodiments) are utilized to provide stimulation to the human who is experiencing a sleep apnea scenario.
  • FIG. 1C illustrates an external unit
  • FIG. ID illustrates the external unit 120 and an implanted unit 110 in signal communication via an inductance coil 707 of the external unit and a corresponding implanted inductance coil (not shown) of the implanted unit, according to which the teachings herein can be applicable.
  • Implanted unit 110 can be configured for implantation in a recipient, in a location that permits it to modulate nerves of the recipient 100 via electrodes 194.
  • implant unit 110 and/or the electrodes thereof can be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle.
  • External unit 120 can be configured for location external to a patient, either directly contacting, or close to the skin of the recipient. External unit 120 may be configured to be affixed to the patient, for example, by adhering to the skin of the patient, or through a band or other device configured to hold external unit 120 in place. Adherence to the skin of external unit 120 may occur such that it is in the vicinity of the location of implant unit 110 so that, for example, the external unit 120 can be in signal communication with the implant unit 110 as conceptually shown, which communication can be via an inductive link or an RF link or any link that can enable treatment of sleep apnea using the implant unit and the external unit.
  • External unit 120 can include a processor unit 198 that is configured to control the stimulation executed by the implant unit 110.
  • processor unit 198 can be in signal communication with microphone 12, via electrical leads, such as in an arrangement where the external unit 120 is a modularized component, or via a wireless system, such as conceptually represented in FIG. ID.
  • FIG. 3 presents an exemplary embodiment of a neural prosthesis in general, and a retinal prosthesis and an environment of use thereof, in particular, the components of which can be used in whole or in part, with some of the teachings herein.
  • a retinal prosthesis sensor-stimulator 10801 is positioned proximate the retina 11001.
  • An image processor 10201 is in signal communication with the sensor-stimulator 10801 via cable 10401 which extends through surgical incision 00601 through the eye wall (although in other embodiments, the image processor 10201 is in wireless communication with the sensor-stimulator 10801).
  • the image processor 10201 processes the input into the sensor-stimulator 10801 and provides control signals back to the sensor-stimulator 10801 so the device can provide processed output to the optic nerve. That said, in an alternate embodiment, the processing is executed by a component proximate with or integrated with the sensor-stimulator 10801.
  • the electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer.
  • the cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.
  • the retinal prosthesis can include an external device disposed in a Behind-The-Ear (BTE) unit or in a pair of eyeglasses, or any other type of component that can have utilitarian value.
  • the retinal prosthesis can include an external light / image capture device (e.g., located in / on a BTE device or a pair of glasses, etc.), while, as noted above, in some embodiments, the sensor-stimulator 10801 captures light / images, which sensor-stimulator is implanted in the recipient.
  • any disclosure herein of a microphone or sound capture device corresponds to an analogous disclosure of a light / image capture device, such as a charge-coupled device.
  • a stimulator unit which generates electrical stimulation signals or otherwise imparts energy to tissue to evoke a hearing percept corresponds to an analogous disclosure of a stimulator device for a retinal prosthesis.
  • a sound processor or processing of captured sounds or the like corresponds to an analogous disclosure of a light processor / image processor that has analogous functionality for a retinal prosthesis, and the processing of captured images in an analogous manner.
  • any disclosure herein of a device for a hearing prosthesis corresponds to a disclosure of a device for a retinal prosthesis having analogous functionality for a retinal prosthesis.
  • Any disclosure herein of fitting a hearing prosthesis corresponds to a disclosure of fitting a retinal prosthesis using analogous actions.
  • Any disclosure herein of a method of using or operating or otherwise working with a hearing prosthesis herein corresponds to a disclosure of using or operating or otherwise working with a retinal prosthesis in an analogous manner.
  • FIG. 4 depicts an exemplary vestibular implant 400 according to one example. Some specific features are described utilizing the above-noted cochlear implant of figure 1 in contacts for the various elements. In this regard, some features of a cochlear implant are utilized with vestibular implants. In the interest of textual and pictorial economy, various elements of the vestibular implant that generally correspond to the elements of the cochlear implant above are referenced utilizing the same numerals. Still, it is noted that some features of the vestibular implant 400 will be different from that of the cochlear implant above. By way of example only and not by way of limitation, there may not be a microphone on the behind-the-ear device 126.
  • sensors that have utilitarian value in the vestibular implant can be contained in the BTE device 126.
  • motion sensors can be located in BTE device 126.
  • other types of processors such as those that process data obtained from the sensors, will be present in the BTE device 126.
  • Power sources such as a battery, will also be included in the BTE device 126.
  • a transmitter / transceiver will be located in the BTE device or otherwise in signal communication therewith. Any one or more of the teachings herein can be used with the arrangement of FIG. 4.
  • the implantable component includes a receiver-stimulator in a manner concomitant with the above cochlear implant.
  • the vestibular stimulator comprises a main implantable component 120 and an elongate electrode assembly 14188 (where the elongate electrode assembly 14188 has some different features from the elongate electrode assembly 118 of the cochlear implant, some of which will be described shortly).
  • internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing.
  • main implantable component 120 includes a processing unit (not shown) to convert data obtained by sensors, which could be on board sensors implanted in the recipient, into data signals.
  • Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals.
  • the electrical stimulation signals are delivered to the recipient via elongate electrode assembly 14188.
  • embodiments shown in figure 4 can include a totally implantable vestibular implant, such as, where, for example, the motion sensors are located in the implantable portion, in a manner analogous to a cochlear implant.
  • Elongate electrode assembly 14188 has a proximal end connected to main implantable component 120, and extends through a hole in the mastoid 119, in a manner analogous to the elongate electrode assembly 118 of the cochlear implant, and includes a distal end that extends to the inner ear.
  • the distal portion of the electrode assembly 14188 includes a plurality of leads 410 that branch out away from the main body of the electrode assembly 118 to electrodes 420.
  • Electrodes 420 can be placed at the base of the semicircular ducts as shown in figure 4. In an exemplary embodiment, one or more of these electrodes are placed in the vicinity of the vestibular nerve branches innervating the semicircular canals.
  • the electrodes are located external to the inner ear, while in other embodiments, the electrodes are inserted into the inner ear. Note also while this embodiment does not include an electrode array located in the cochlea, in other embodiments, one or more electrodes are located in the cochlea in a manner analogous to that of a cochlear implant.
  • FIG. IE is a side view of the internal component (implantable component) of cochlear implant 100 without the other components of system 10 (e.g., the external components).
  • the implantable portion of cochlear implant 100 comprises a receiver/stimulator 180 (combination of main implantable component 120 and internal energy transfer assembly 132) and a stimulating assembly or lead 118.
  • Stimulating assembly 118 includes a helix region 182, a transition region 184, a proximal region 186, and an intra-cochlear region 188.
  • Proximal region 186 and intra-cochlear region 188 form an electrode array assembly 190.
  • proximal region 186 is located in the middle-ear cavity of the recipient after implantation of the intra-cochlear region 188 into the cochlea.
  • proximal region 186 corresponds to a middle-ear cavity sub-section of the electrode array assembly 190.
  • the electrode assembly 145 is biased to curl and will do so in the absence of forces applied thereto to maintain the straightness. That is, electrode assembly 145 has a memory that causes it to adopt a curved configuration in the absence of external forces.
  • electrode assembly 145 is pre-curved to have a radius of curvature that approximates and/or is less than the curvature of medial side of the scala tympani of the cochlea.
  • a perimodiolar electrode assembly such embodiments of the electrode assembly are referred to as a perimodiolar electrode assembly, and this position within cochlea 140 is commonly referred to as the perimodiolar position.
  • placing electrode contacts in the perimodiolar position provides utility with respect to the specificity of electrical stimulation, and can reduce the requisite current levels thereby reducing power consumption.
  • this provides for dimensional stability of the electrode array, and/or can be sized and dimensioned to control the ultimate volume of the overmoulded material 890, where the greater volume of the riser 8499, the less volume of the overmoulded material 890.
  • the riser portion 8499 is not extend the full length of the longitudinal protrusions, although it could in some embodiments.
  • the cross-section shown it can be seen how the riser gradually descends into the main portion of the carrier member with position in the apical direction, and that ultimately becomes nonexistent for a portion of the distance along the longitudinal protrusions.
  • figures 20 and 21, which are views looking downward on the top of the electrode array where the electrodes are on the opposite side, and thus looking downward on to the bounded areas, show exemplary respective boundary arrangements 810.
  • the protrusion extends all the way around the enclosed area. Note also that in the embodiment of figure 21, the protrusion extends outboard a bit with respect to the rest of the body of the carrier.
  • figure 21 shows both the longitudinally extending protrusions being so outboard along the entire length, in another embodiment, it is only along a portion of the length that is outboard, as seen in figure 22.
  • figure 23 shows two protrusion arrangements located on the dorsal side, the protrusion arrangements spaced apart from each other. Also as can be seen, the protrusion arrangement on the left is completely in board of the outer profile of the general carrier body when viewed from the top, while the protrusion arrangement on the right has the longitudinal portions outboard of the general carrier body/the rest of the carrier body. And while these protrusion arrangements are spaced apart from each other, in an embodiment, they can be in direct contact with each other. Indeed, in an exemplary embodiment, the protrusion arrangements can share a lateral portion. This is seen in figure 24.
  • Figure 18 shows an exemplary cross-section where the surface moves downward (at the top) after the surface has stopped moving upward with respect to movement in a clockwise fashion from the bottom of the array to the top of the array (from 6 o’clock to 12 o’clock). [ooioo] In an embodiment, referring to FIG.
  • D65 can be less than, greater than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.40, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47 mm or any value or range of values therebetween in 0.005 mm increments.
  • a value of rcl, the radius of curvature of the protrusion can be less than, greater than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32 or 0.33 mm or any value or range of values therebetween in 0.005 mm increments and rc2, the radius of curvature of the lead out to the protrusion can be less than, greater than or equal to 0.25, 0.5, 0.75, 1, 1.5, or 2 or 2.5 or 3 or 4 or 5 or 6 or any value or range of values therebetween in 0.05 increments times rcl.
  • first cross-section of the electrode carrier member lying on a plane that is normal to a first axis (e.g., the longitudinal axis) of the electrode carrier member.
  • the raised area / protrusion forms an outer periphery of a portion of the crosssection.
  • the percentage of the outer periphery formed by the protrusion is less than, equal to or greater than 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,1 6, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30%, or any value or range of values therebetween in 0.1% increments (e.g., 11.3%, 26.4%, 7.3% to 22.2%, etc.) or more.
  • the value would be half any of those numbers because the noted value was for a protrusion and there would be two protrusions (the combined periphery for the two protrusions would equal those numbers).
  • the protrusion portion begins where the outer profile of the carrier body changes in a manner inconsistent with what one would otherwise expect.
  • the structure is part of the fuselage for example, but it is different from the areas around the sponson. It is not what one would expect with respect to the overall shape and contours of the fuselage.
  • the beginning of the protrusion is a transition point as noted above, and the beginning is something that changes in a manner inconsistent with what one would otherwise expect.
  • the end can also be a transition point, but the end could be at a location where the outer profile of the carrier member changes in a manner consistent with what one would expect without the protrusion.
  • the transition point that indicates the beginning of protrusion 825 with respect to location along the outer periphery the cross-section with movement in the counterclockwise direction is a transition point.
  • the vertical linear sidewall transitions to a curved concave (with respect to the outside of the cross-section) portion, whereas one would expect the outer profile to continue going upwards and the vertical direction in a linear manner.
  • the outer profile of the cross-section of the protrusion portion (as opposed to the collective protrusion on the cross-section) has a constant radius for at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of value therebetween in 1% increments.
  • the outer profile of the cross-section of protrusion 825 of figure 18 has a constant radius for over 50% of the outer profile thereof (it is constant for more than 3/4ths of the total outer periphery).
  • the outer periphery of the portion 825 has a convex portion and a concave portion (both relative to outside the carrier member), and only one of each.
  • the portion 825 is bounded by two linear portions of the carrier member.
  • the exemplary embodiment shown in figure 18 has the compound surface just noted, in an alternate embodiment, the portion can be established by a convex portion only. This can be established by, for example, having the protrusion extend out from the vertical side in an abrupt manner instead of the curved transition shown. The vertical side of the carrier could extend up to the beginning of the for example constant radius bulbous protrusion.
  • the protrusion 825 can rise above that flat surface and then extend downward meeting that flat surface and transitioning to the flat surface in an abrupt manner.
  • the outer periphery of the cross-section of the protrusion 825 can be a compound curve (and thus compound surface with respect to the third dimension into and out of the page (all references to a curve herein correspond to an alternate disclosure with respect to the surface as it extends into and out of the curve)) that is established by two concave portions and a convex portion in the middle.
  • the protrusion could rise above the top surface of the carrier (above with respect to the direction in the Y axis with respect to the planar image of figure 18 for example) and then curved back downward to that top surface with a concave curve (all references to convexity and concavity are with respect to location outside of the carrier member unless otherwise noted).
  • the outer surfaces can be linear.
  • a linear surface could be utilized to reach the convexly curved portion and then a linear surface could be used to extend from the convexly curved portion to the top linear portion. Indeed, this is seen in FIG. 9 with respect to portion 830.
  • the top surface of the carrier member is straight and in some embodiments tapered, and then it transitions to the concave portion of the protrusion 830 which then transitions to the convex portion of the protrusion 830, and then transitions to a linear portion having a negative slope sloping down to the surface 840 / section 840, which then meets surface 840 at an oblique angle with respect to the cross-section, where the carrier member / surface 840 extends linearly in the proximal direction from that transition point which marks the end of the protrusion 830.
  • the transition point can encompass a distance in the longitudinal direction or a distance normal to the longitudinal direction.
  • the transition point can otherwise lie in a circle lying on a plane, where the circle has a diameter that is less than 0.25, 0.2, 0.15, 0.1, 0.05, 0.04, 0.03, 0.02 or 0.01 mm or any value or range of values therebetween in 0.005 mm increments.
  • the concept of the transition point is measured from the beginning of the transition point to the end of the transition point.
  • the concept might otherwise be characterized as a “transition area.”
  • an entirely linear series of surfaces could be utilized. This could appear as a faceted cross-section. Any arrangement of a protrusion a raised area that can enable the teachings detailed herein can be utilized in at least some exemplary embodiments.
  • first cross-section of the electrode carrier member lying on a plane that is normal to a first axis of the electrode carrier member that includes a first portion of a teardrop outer profile of the protrusion.
  • the outer profile of protrusion 830 is less than a half of a tear drop shape (half the lateral side).
  • the beginnings of the teardrop shape can also extend into a section that is not teardrop, again as seen in figure 9 with respect to protrusion 830.
  • this cross-section of the carrier member can have a portion that has another partial teardrop shape / a portion of a teardrop outer profile. This can be the case with respect to protrusion 860.
  • a second cross-section of the electrode carrier member lying on a plane that is normal to a second axis of the electrode carrier member that is normal to the first axis of the electrode carrier member includes a second partial teardrop outer profile of the protrusion him.
  • This cross-section can also include a third partial teardrop outer profile of the protrusion him.
  • an outer profile of the second cross-section of the electrode carrier member is symmetrical about a plane lying on and parallel to the first axis.
  • the partial teardrop shape exists with respect to the portions that are “above” the proximal portions of the top of the carrier member with respect to protrusion portion 830 and the portion that are above the distal portions of the top of the carrier member with respect to protrusion portion 860.
  • the convex portion of the protrusions with respect to movement from proximal to distal along the top surface of the carrier member, are at the altitude of the carrier member immediately before the beginning of the protrusion with respect to protrusion portion 830 (see 888), and are at the altitude of the carrier member immediately after the end of the protrusion with respect to the protrusion portion 860 (again, see line 888).
  • the portion below that altitude is linear and slopes downward to surface 840. The opposite is the case with respect to protrusion portion 860.
  • the embodiments present a protrusion that has a portion that “blends” into the remainder of the carrier member outside the perimeter established by the protrusion arrangement / on the side opposite body 890
  • the blend is not present.
  • the protrusion rises like a dome (whether a half sphere or a portion of a half sphere (in which case the base does not rise up at an immediate 90 degree angle, but rises up at a lower angle, but this is as contrasted from the teardrop / blend, which starts off at zero and then increases - the blend is the opposite of the dome, which starts off at an abrupt value and then decreases from there).
  • This concept can also apply to the cross-sections of the carrier member lying on a plane normal to the longitudinal axis, but instead of altitude it is location with respect to the outboard directions.
  • line 877 represents the baseline for the side of the carrier member without protrusion portion 820. If the line 877 represents how the carrier member would extend in the absence of the protrusions, everything outboard of that line would be the protrusion, and everything in board of that line would simply be a feature associated with establishing the recess in the top of the carrier member. Thus, the portion that extends inboard of that line could be considered not part of the protrusion.
  • these lines 877 and 888 can be ascertained by comparing the other portions of the carrier member before and after and to the sides of the protrusion portions.
  • this shows the cross-section of the carrier member with respect to the view of figure 13, except that there are no protrusions added to the carrier member. Only the recess portion for the surface 840 is present in this arrangement (whereas the top surface would be higher but for the lack of the recess portion). This is what the carrier member would look like without the protrusions. Accordingly, if one superimposes what the carrier member would look like without the protrusions over what the carrier member looks like with the protrusions, the difference constitutes the protrusions in this conceptual arrangement.
  • figure 27 presents the view of figure 16, except without the protrusions, where this view, because it is looking towards the proximal portion of the electrode array from the distal portion of the electrode array, shows where the carrier member is located after the recess in the top of the carrier member ends, represented by curve 8497. This aids in showing where the recess is located relative to that which would otherwise be the case. Still, the concept of taking the protrusion as the entire shape as opposed to extrapolating what would exist in the absence of the protrusion and otherwise declaring the Delta to that the protrusion is a slightly different concept than that which was explained above.
  • the segmented protrusions can be considered raised sections, and thus embodiments include a plurality of raised sections located between the first and second sections, the raised sections being raised relative to the section lower than the raised area.
  • the raised sections / segmented protrusions can be / are resiliently compressible.
  • the material of the raised area is as resiliently compressible as the material of the other portions of the carrier member.
  • the raised area is more readily compressible relative to other portions of the carrier member owing to the geometry of the local portions of the carrier member that make up the raised area.
  • embodiments include segmented protrusions that are monolithic with the other portions of the carrier member.
  • embodiments have focused on a partial teardrop shape that is less than half a teardrop shape, embodiments can utilize half a teardrop shape.
  • the portions below the altitude of those lines until surface 840, with respect to the side view or otherwise a crosssection lying on and parallel to the longitudinal axis of the carrier member, are flat and tapered or otherwise sloped downward from the end of the curved portion of the protrusion portion to surface 840.
  • this flat tapered surface is uniform with respect to rotational angle about the longitudinal axis until the longitudinal portions 820 and 825 are reached.
  • the surface 840 is a curved surface with respect to position about the longitudinal axis.
  • the surface 840 is flat with respect to position about the longitudinal axis (e.g., that surface increases distance from the longitudinal axis with position outboard from the center of the carrier member, whereas the curved surface can be curved around the longitudinal axis so that the points on that surface are equally distant from the longitudinal axis, at least with respect to cross-sections that are normal to the longitudinal axis). Accordingly, the “height” of the flat tapered portion would decrease with respect to location outboard of the carrier member/protrusion in some embodiments, while in other embodiments, the height would remain the same and then ultimately blend into the longitudinal portions.
  • FIG. 15B shows a cross-sectional view of the carrier corresponding to the view indicated in FIG. 15 A. This better shows the protrusions 825 (and 830) and 820 (and 830) than in FIG. 15.
  • the cross-sectional view is taken to show the “highest altitude” of those protrusions (greatest distance from the longitudinal axis) and/or to show the cross-section thereof at the highest altitude until the protrusion arrangement transitions to the purely longitudinal section.
  • Embodiments include assembly, such as a stimulating assembly, such as a cochlear implant electrode array, or retinal prosthesis array, etc., comprising a plurality of electrode contacts and electrode carrier member.
  • This assembly further includes a barrier extending on an outside of the carrier member. In an embodiment, the barrier is established by the protrusion arrangement detailed above.
  • the barrier extends on a side of the carrier member different than the side on which the electrode contacts face (as opposed to the sides of the contacts where the contacts are U shaped, which are on sides of the side on which the electrode contacts face) or a side of the carrier member different than a side on which the centers of the electrode contacts are located (all of these are opposite the dorsal portion of the array) and/or with the carrier member in a straightened orientation (recall that the carrier member can establish the array is a pre-curved electrode array that is biased to curve in the absence of exterior forces - this feature is measured by straightening the electrode array), in a direction generally and/or substantially parallel (both of which includes parallel) to a vector extending through at least two of the electrode contacts of the plurality of electrodes and past the at least two electrodes.
  • the barrier can extend on the lateral sides of the array or on the top of the array (the dorsal portion of the array).
  • this vector must extend through two of the electrode contacts somehow.
  • this vector could extend through for example the topmost proximal most portion on the left side of the electrode 7, and extends through for example the bottom most distal most portion on the right side of the electrode 8.
  • the two electrodes are the closest to electrodes of the assembly, or at least the electrodes carried by the carrier member. Electrodes of the assembly, or at least the electrodes carried by the carrier member.
  • the electrodes are within one, two, three, four, five, six, seven, eight, or nine electrodes of each other, or any value or range of values therebetween in one electrode increments, with respect to location along the longitudinal axis of the carrier or otherwise with respect to location along the established vector.
  • the plurality of electrodes includes any of the numbers detailed above, and with respect to location along the vector (or longitudinal axis), the barrier extends past the at least number of electrodes. Note that there could be more electrodes than the at least a number of electrodes. The barrier simply must extend past that number of electrodes. In note that vector need not extend through all of those electrodes, but in some embodiments, the vector does extend through all those electrodes, at least when the carrier member is in the straightened orientation. And those electrodes could be sequential / serial in at least some exemplary embodiments.
  • the barrier is a monolithic part of the electrode carrier member. That said, in an embodiment, the barrier can be a separate component that is attached or otherwise overmoulded to the electrode carrier member.
  • the carrier member is monolithic with respect to location along the longitudinal axis from the first electrode to the last electrode. In an embodiment, the carrier member is monolithic with respect to distance along the longitudinal axis for any one of the electrodes to any of the other electrodes detailed herein.
  • the carrier member is monolithic from electrode 1 to electrode 10, and then a second carrier member is moulded to that carrier member, which second carrier member extends from electrode 11 to electrode 17 for example.
  • the entire barrier or otherwise protrusion arrangement is monolithic.
  • one or more portions of the protrusion arrangement are separate from one or more other portions of the protrusion arrangement, separate in terms of being distinctly different components, as opposed to arbitrarily divided up or otherwise divided up with respect to location, such as is the case with respect to the embodiment of figure 8, where the protrusion portions are identified with respect to their location on the array. These are separate sections, but not separate components.
  • the barrier can be an endless barrier.
  • endless barrier does not require that the portions of the barrier be monolithic with each other. This covers a barrier that has no true beginning and no true end. This is analogous to a conveyor belt for example, which is sometimes referred to as an endless belt.
  • the carrier member is an elongate carrier member.
  • the barrier bounds and/or surrounds a lower area relative to the barrier.
  • This concept of the lower area relates to the local altitude with position about the longitudinal axis of the electrode array for example, as described above.
  • the barrier is above that surface 840 with respect to local location about the longitudinal axis, even though with respect to the purely Cartesian coordinate system of the view of figure 13, surface 840 does not extend below any portion of the barrier, and in terms of the concept of the design barrier, with respect to location in the Y axis, the barrier is actually below surface 840.
  • FIG. 13 presents such a cross-section over which the polar coordinates are presented.
  • the zero angle is located at the 6 o’clock position, or otherwise with respect to the Y axis and the negative direction.
  • Reference letter r is the distance from the longitudinal axis or otherwise the axis of symmetry or otherwise the geometric center of the carrier member with respect to the cross-section at issue to the outer profile of the carrier member.
  • Theta is the angle that the vector presenting the value r is from the Y axis starting at the bottom.
  • the 0° angle is where the electrodes are located or otherwise where the center of the electrodes are located in at least some exemplary embodiments.
  • the value of r steadily increases with an increase in the angle Theta, which increases linear.
  • the angle then increases at a lower rate or stops increasing or potentially even decreases when the vector reaches the curved portion and the third quadrant.
  • the value of r begins to decrease at the linear portion in the third quadrant but then begins to increase in a nonlinear manner at about the beginning of the fourth quadrant with increasing Theta. In this regard, this is the beginning of the protrusion 825.
  • the value of r then begins to decrease at about 110 or 105 degrees or so, and the decrease is nonlinear and increases with respect to the rate of decrease.
  • the decrease then begins to be linear when it reaches the surface 840, although in an alternate embodiment, the value of r could be constant for the surface 840, such as where the surface 840 is curved and otherwise follows an arcuate profile.
  • the value of r increases when the riser 8499 and/or the segmented protrusion 850 is reached but the value of r would continually decrease if the surface 840 was flat from portion 825 to portion 820 until reaching angle 180°, and then would increase again. The pattern would be reversed upon reaching the portion 820.
  • the value of r between angles 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 125, 130, 135, 140, or 145, or any value or range of values therebetween in 1° increments is a value that is greater than or at least equal to a value that is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25, or any value or range of values therebetween in 0.1 increments percent greater than the values of r immediately before and/or immediately after those values.
  • the value of r for any one or more of those angles can equal any one or more of those values with relation to a value of r at any of the angles 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 degrees, or any value or range of values therebetween in 1° increments.
  • These properties are symmetric about the Y axis, or alternatively, if Theta is measured in the counterclockwise direction again starting at the bottom of the Y axis, those values are present, because in an exemplary embodiment, the carrier member and the electrode array, at least with respect to the outer profiles, are symmetric about the Y axis.
  • the polar coordinate system can be applied to the cross-sections that pass through the lateral protrusion portions 830 and 860.
  • the value of r decreases between transition points T2 and T3 with increasing angle Theta, but at transition point T3, even though the value of r should continue to decrease with increasing Theta, the value of r could become constant or increase with increasing Theta, or at least the rate of change of the value of r would be different than that which was the case prior to T3.
  • the directions of extensions of the lateral portions could include a longitudinally extending vector in addition to the lateral extending vector.
  • the ends of the longitudinal portions could be “capped” by very shallow sideways “V”s (when viewed from the top). Or “U” shaped ends could be used. That said, non-shallow “V”s could be used where the vector in the longitudinal direction is greater than the vector of the lateral direction.
  • lateral portions and longitudinal portions are dictated by the greatest vector associated with the extension thereof.
  • the longitudinal portions need not extend perfectly longitudinally, as there can be a lateral vector associated with the extension.
  • an elongate diamond shape can be the form of the protrusion arrangement. In such an embodiment, there is no portion that extends in a purely longitudinal direction but if the diamond is long enough, and narrow enough, there will be no lateral portion by the definitions detailed above.
  • FIG. 28 presents an exemplary flowchart for an exemplary method, method 2800.
  • method action 2810 can be executed by removing the cochlear implant electrode array from a mould after moulding the silicone carrier member so that it carries the electrodes, etc.
  • this can be executed by obtaining a package electrode array hours or days or weeks or months after the electrode array is manufactured or otherwise is removed from a mould.
  • method action 2810 is executed by opening up a container in which the electrode array is contained for storage or for transportation from a location where the electrode array was manufactured to the location where method action 2800 is being executed. In an embodiment, method action 2810 is executed by receiving an electrode array laying on a tray. In an embodiment, method action 2810 is executed by receiving a hermetically packaged electrode array. In an exemplary embodiment, method action 2810 is executed by receiving a sterile cochlear implant electrode array.
  • Method action 2820 includes the action of placing the electrode array in a mould cavity.
  • this mould cavity is different than that which was described above with respect to the action 2810.
  • this mould cavity is seen in figures 29-31.
  • Figure 29 represents a cross-sectional view of a portion of a bottom piece 2915 of the mould 2910, in which is located an electrode array 846 as shown, although in an embodiment, it can be the electrode array 146 as detailed above, with respect to a mould that is modified from that under discussion, as will be detailed below.
  • method action 2820 includes placing the electrode array 846 into the mould subcavity 2950 of piece 2915, and then closing the mould subcavity 2950 with the opposite piece, thus trapping the electrode array 846 in the mould cavity formed by subcavity 2950 and the subcavity of the opposite piece.
  • the mould cavity can be such that the electrode array has a curved orientation, whether that curved orientation is the relaxed orientation, or substantially relaxed orientation, or whether that curved orientation is an orientation that is in between its relaxed orientation and the fully straighten orientation.
  • the curvature of the electrode array with respect to its relaxed position is reduced (actually, expanded with respect to local radii of curvature) by less than, equal to, or greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500, or 3000%, or any value or range of values therebetween in 1% increments or more.
  • the radius of curvature is increased by an effectively infinite amount and thus greater than 3000%.
  • embodiments of the mould 2910 are shown as having two components or otherwise two mould pieces, embodiments can include a mould that has three or more components. Note also that the components may not necessarily be mirror images of each other.
  • mould piece 2915 could actually have a “larger” sub cavity portion than the opposite mould piece. This can be utilitarian with respect to securing the electrode array into that mould sub cavity 2950. For example, if the mould sub cavity 2950 extended about more than 180° of the electrode array, the portions of the mould sub cavity 2915 that extend beyond 180 degrees would work to secure or otherwise hold the electrode array in the mould subcavity until the opposite piece is placed over the mould subcavity to create the entire cavity.
  • the electrode array can easily be removed from the after the opposite piece is taken away from piece 2915 (and of course, can easily be placed into the mould subcavity 2915 because of the resilient and flexible nature of the silicone).
  • method 2800 further includes method action 2830, which includes the action of overmoulding a substance onto a portion of the array that was placed into the cavity in method action 2820 to form a modified cochlear implant electrode array, the mould cavity forming an exterior surface of the substance (forming in the sense that the mould “forms” the surface, and the surface would have another form if the mould cavity was different).
  • the overmoulded substance forms an overmould on the electrode array.
  • the overmould is located on the dorsal portion of the electrode array.
  • the overmould is located within the boundaries of the protrusion arrangement 810 above.
  • the overmould is not located within any protrusion arrangement. Indeed, in an embodiment, there is no protrusion arrangement of the electrode array.
  • the overmould on the electrode array establishes a stiffer portion of the electrode array relative to the carrier member so as to establish a resistance to Euler buckling during insertion.
  • the overmould is an additive to the functionality of the electrode array, and otherwise has utilitarian value in addition to the general utilitarian value of the electrode array without the overmould.
  • overmould it is meant a structure or a body that is distinctly separate from the carrier member of the electrode array. In this regard, it is not monolithic with the carrier member.
  • the overmould can be the exact same material as the carrier member. However, the distinctness between the overmould and the carrier member can be ascertained.
  • method 2800 results in the formation of a modified cochlear implant electrode array.
  • the electrode array that is placed into the mould cavity in method action 2820 is an electrode array that is a functional electrode array and otherwise is, for all intents and purposes, ready for use with respect to its intended purpose.
  • the electrode array is an implantable electrode array
  • the electrode array is ready for implantation (providing that it is sterilized or any other of the finalization actions are executed).
  • the overmould is an additional feature of the array and otherwise enhances the utilitarian value of the electrode array, or otherwise provides additional utilitarian value of the electrode array.
  • the overmould can be seen in figures 12 and 13 and 16 and 18 for example, as overmould 890.
  • Figure 32 shows the modified electrode array 8461 that results from method 2800.
  • the outer boundaries of the overmould are established by the protrusion arrangement 810.
  • the mould cavity compresses the protrusion arrangement 810 when the pieces of the mould are placed together, and the mould pieces are tightened against one another.
  • the mould cavity has interior dimensions that are different, and at some locations, smaller, then the exterior dimensions of the electrode array placed in the mould cavity.
  • the resilient and flexible nature of the protrusions “push back” against the interior of the mould cavity and thus create a seal or otherwise a barrier between one side of the protrusion portion and the other side of the protrusion portion.
  • the overmould material when the overmould material is injected into the mould cavity via channel 2920, the overmould material will flow into the space 2929 between the electrode carrier 849, and the mould surface 2950, which space is bounded by the protrusion arrangement and then the surface 840 therein, where the combination of such forms a basin, and then the surface 2950, which surface arcs around the top of the electrode array 846 about the longitudinal axis of the electrode array.
  • the overmould material will fill or at least partially fill that space, and will not flow past the protrusion arrangement 810, because the surface 2950 compresses the protrusion arrangement a sufficient amount to create a seal between the carrier member and the interior surface of the mould cavity.
  • vents 2932 act to relieve or otherwise mitigate a pressure increase inside the aforementioned space inside the protrusion arrangement 810.
  • excess overmould material will flow out of the vents 2932 and 2930 which are located at the distal and lateral ends of the protrusion arrangement.
  • any excess overmould material that has flowed into the vents can be removed such as by cutting or clipping.
  • the protrusion arrangement forms a barrier that prevents movement of the overmould material during the moulding process from one side of the protrusion arrangement to the other side of the protrusion arrangement.
  • This can have utilitarian value with respect to establishing and overmould body that has dimensions that fall within a desired tolerance relative to that which would otherwise be the case.
  • this can be an automated process with respect to the amount of overmould material that is flowed into the mould cavity.
  • upon a pressure or a certain volume being reached volume of overmould material flowing into the cavity
  • continued flow is halted. That said, in some embodiments, no control monitoring is applied.
  • vents are relied upon to alleviate any pressure arrangement.
  • it is the structure of the electrode array and the mould cavity that establishes the amounts of overmould material that is located on the electrode array, with the exception of the amounts that flow into the vents. This is opposed to, for example, depositing the overmould material on to the top of the array by hand or otherwise doing so without the mould surface 2590 present.
  • a surface of the overmould body 890 is formed or otherwise established by a mould surface, such as surface 2950.
  • the substance that is overmoulded onto the carrier member is halted from traveling past a discrete location on the cochlear implant electrode array so that there is another portion of the array without the substance.
  • this is executed utilizing the protrusions on the carrier member.
  • it is the mould that includes protrusions that deform the carrier member so as to prevent the movement of the substance.
  • an embodiment includes a method where the mould cavity includes a structure that compresses the electrode array over a defined discrete area that encloses another area during the overmoulding, the compression being more than areas adjacent the discrete area and the “another area” is where the substance is overmoulded.
  • Figure 33 shows a cross-section of an exemplary mould that includes two pieces 3216 and 3215, which pieces are analogous to the pieces noted above with respect to mould 2910.
  • this view is shown with respect to a direction looking down the longitudinal axis of the electrode array, with the electrode array in the mould cavity when the mould is fully closed.
  • mould piece 3215 includes protrusion 3215 A
  • mould piece 3216 includes protrusion 3216A.
  • the mould pieces compress and otherwise deform the body of the carrier member 849 as shown, where in its relaxed on deform state, the sidewalls of the carrier member 849 at the locations where the protrusions are now located are linear and vertical (as represented by the vertical phantom line on the left side of the carrier).
  • embodiments can include a combination of the protrusions on the carrier member and the protrusions on the mould cavity surface.
  • the crest of the protrusion of the mould cavity can coincide with the crest of the protrusion of the carrier member so that maximum deformation is achieved when the mould pieces are closed together so as to establish the aforementioned barrier or otherwise seal.
  • the mould cavity includes a structure that deforms the electrode array over a defined discrete area to form a barrier that halts the substance from traveling past the discrete location.
  • the electrode array includes a structure that is compressed over a defined discrete area that encloses another area during the overmoulding, the compression being more than that at areas adjacent the discrete area (e.g., inside or outside the border formed by the protrusion on the mould, or the protrusion on the array).
  • the compression as measured by strain, is equal to or greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500 or 3000, 4000, 5000, 6000, 7000% or any value or range of values therebetween in 1% increments or more than that at another location that is 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225, 0.25, 0.275, 0.3, 0.35, 0.4, 0.45, or 0.5 mm away or any value or range of values therebetween in 0.01 mm increments from the compression (surface distance, as opposed to linear distance (New York to Sydney is 12,000 miles, not the 8,000 miles through the center of the Earth)), or at the adjacent area, or within the bounded area.
  • the value could be infinite if there is zero compression at the another area / location.
  • the “another area” is where the substance is overmoulded.
  • the aforementioned difference exists over at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of where the substance is overmoulded (that is, directly in contact with the carrier member), with respect to an average (mean, median and/or mode) of the compression (the larger compression) and/or a maximum compression.
  • this can be estimated based on the mould features and/or the electrode array features (including the makeup of the protrusion on the array).
  • the electrode array includes a structure that deforms when in the mould cavity over, the deformation forming a barrier that halts the substance from traveling past the deformed structure.
  • the deformation can be gauged according to any of those examples detailed above.
  • the barrier that is formed on the electrode array is a means for sealing for an overmoulding process.
  • the protrusion is a sealing bump.
  • the outer boundary of the overmoulding material is bounded by the protrusion arrangement when viewed from the top of the electrode array.
  • the lateral outer boundary of the overmoulding material is bounded by the protrusion arrangement.
  • the protrusion extends around the overmoulding body that is attached to the outside of the carrier member.
  • An embodiment can include a cavity of the overmould mold that is flush with what would be the surface of the electrode array without the protrusions, which enables the sealing because the protrusions are compressed / the carrier is compressed to what the carrier would have been, or at least about what the carrier would have been, without the protrusions.
  • a pressure within the mould during the injection process can be 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2250, 2500, 2750 or 3000 KPa or any value or range of values therebetween in 10 KPa increments.
  • Figure 19 presents a variation of the teachings detailed herein.
  • the shape of the carrier member has portions 825X and 820X that have at least some of the features of the transition points detailed herein, but where the feature here is that after reaching a high point with respect to direction and the Y axis, the outer profile of the carrier member decreases in altitude with location closer to the Y axis.
  • the closure of the mould pushes the portions 825X and 820X inward and upward, which compresses the carrier member, and thus creates a seal between the mould cavity and the portions of the carrier member that are “below” the compressed portions.
  • the barrier does not extend about one or a plurality of electrode contacts. That is, the barrier extends about an area that does not encompass the electrodes. Indeed, in an exemplary embodiment, the barrier is located entirely in a “hemisphere” opposite the electrodes, or at least the center of the electrodes. That said, figure 19A shows an example of a barrier that does extend about the electrodes 148 (there would be lateral portions at the proximal and distal ends of the enclosed area. [00154] As noted above, in some embodiments, there are one or more raised segmented portions 850 inside the boundary established by the protrusion arrangement.
  • the raised segmented portions 850 provide additional adherence of the overmoulded body to the carrier member.
  • the raised segmented portions 850 are sized and dimensioned to results in a desired volume of overmoulding material resulting from the overmoulding process.
  • the raised segmented portions 850 extend into the cavity that is established between the electrode array and the remainder of the surface of the mould that is not in contact with the electrode array. This is the cavity into which the overmoulding material flows into during the overmoulding process.
  • the resulting volume of the overmoulding body can be varied.
  • embodiments include designing and manufacturing protrusions of a given design and/or given dimensions so as to achieve a desired volume of overmoulded material.
  • the protrusions can be formed on the electrode array, and then one or more can be removed prior to the overmoulding process/prior to being placed into the mould for the overmoulding process, so as to increase the resulting volume of the overmoulded body.
  • the segmented protrusions are designed and configured to be accurately removed from the electrode array.
  • a surgical scalpel can be used to slice off one or more protrusions.
  • the protrusions can be segmented or otherwise can include a weakened area to facilitate the removal thereof.
  • the segmented protrusions can also provide utilitarian value with respect to providing additional surface for the overmould body to “grip” to the array, and provide more localized gripping, which can be utilitarian because of the fact that the overall array will curl, and thus a pure locally planar face adherence might be more likely to fail / come apart when the array is curled.
  • the segmented portions 850 are segmented protrusions, as detailed above.
  • the segmented protrusions 850 are not sealing protrusions, and otherwise do not prevent the flow of the overmoulded material from reaching an opposite side of the carrier member. Note also that this is the case with respect to the riser 8499. The riser does not prevent the overmoulded material from flowing from one side of the carrier to the opposite side of the carrier. In this case, the riser portion is not a sealing portion.
  • the segmented portions 850 are sized and dimensioned so as to contact surface 2950 of the mould cavity. That said, some protrusions are sized and dimensioned so as to not touch the surface 2950 the mould cavity. Accordingly, the overmoulded material will flow over the tops of some of the protrusions and not others during the moulding process. This can be seen in the top view of the modified electrode array 8461 in figure 31, where segmented protrusions 850A extend through the top of the overmoulded material 890 and thus form islands in the overmoulded material, whereas others 850B remain beneath the outer surface of the overmoulded material 890.
  • protrusions there are 10 protrusions inside the protrusion arrangement 810. Six of these extend through the top of the overmoulded material 890. In other embodiments, more or less protrusions are present and/or more or less protrusions extend through the top of the overmould 890. In an embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, or 50, or any value or range of values therebetween in 1 increment protrusions inside the protrusion arrangement and/or in contact with the overmould body 890, not including the protrusion(s) that make up the boundary.
  • the protrusions can be arrayed in a nonlinear manner and/or a non-serial manner.
  • the protrusions can be arrayed in parallel in 2 columns were even 3 columns depending on how much room there is inside the protrusion arrangement, and the protrusions can be aligned with each other or otherwise abreast with each other, or the protrusions can be in lockstep one after the other.
  • protrusions as elongate rakes track tape shapes
  • other embodiments can include protrusions of different shapes.
  • figure 25 shows various shapes of segmented protrusions 850 when viewed from the top.
  • the material of the overmould body 890 is a flexible material.
  • the overmould body 890 is made of silicone, such as biocompatible silicone.
  • the overmoulded body is made of the same silicone as the carrier member.
  • the overmould body is made of the same class of silicone as the carrier member.
  • the overmould material has flexibility that is less than and/or greater than and/or equal to that of the carrier member.
  • the overmould material has a flexibility and/or density within 5, 10, 15, 20, 25, or 30% or any value or range of values therebetween in 1% increments or more of the flexibility of the material of the carrier member.
  • the overmould material is a combination of silicone and a therapeutic substance. It can be a mixture of such when the material is injected into the mould cavity, where in an exemplary embodiment, a dispersion of the therapeutic substance in the silicone is uniform or substantially uniform, and thus when the silicone sets or otherwise cures, the dispersion of the therapeutic substance within the cure silicone is also uniform.
  • the therapeutic substance elutes and/or diffuses out of the silicone and into the body of the recipient, such as when the array is an implantable array.
  • the overmould material of the overmould body 890 can be any therapeutic substance delivery silicone based materials currently available, such as those that are utilized with cochlear implant electrode arrays. In an embodiment, the material is a .
  • the therapeutic substances could be Dexamethasone, base, acetate, sodium phosphate, Prednisone, Fluticasone, Other cortico steroids, BDNF/NT3 Gene therapy (or other biologies).
  • the silicone could be a biocompatible silicone excipient with a durometer of 5-80 shore A, Nusil, DDU-4320, DDU-4870, Elkem D125, D140, etc.
  • any material that can enable the delivery of a therapeutic substance within a body, such as within a cochlea, such as within the scala tympani, after implantation, that can have therapeutic value and can be injection moulded in accordance with the teachings above or variations thereof to establish the overmould body 890 can be utilized in at least some exemplary embodiments.
  • the overmoulded body provides utilitarian value with respect to delivering a drug or other therapeutic substance to a human internally, such as in the cochlea.
  • embodiments are directed towards a therapeutic substance delivery system.
  • Therapeutic substances include drugs, but also include nondrug substances.
  • therapeutic substances include steroids and biologies.
  • Therapeutic substances can also include minerals and the like.
  • an anti-inflammatory drug such as Dexamethasone is mixed into an uncured silicone, which mixture is injected into the overmoulding mold, and overmoulded over the carrier member, and when cured, forms the modified electrode array.
  • a therapeutic substance that is a drug that is mixed in a silicone separate from the electrode array carrier.
  • the devices can be devoid of glue holding the therapeutic substance and/or the therapeutic substance is a drug that is mixed in a silicone separate from the electrode array carrier.
  • the overmoulded body dissolves in part to transfer the therapeutic substance into the cochlea / the perilymph of the cochlea.
  • the therapeutic substance or drug can elute from the overmoulded body.
  • the overmolded body can extend a distance that is equal to less than, or greater than 150, 140, 130, 120, 110, 90, 80, 70, 60, 50, 40, 30, 20 or 10% or any value or range of values therebetween in 1% increments of DI.
  • the protrusion on the outside of the carrier member extends around a therapeutic substance attached to the outside of the carrier member.
  • the therapeutic substance can be entrained or otherwise dispersed in a silicone material.
  • there is an assembly or an apparatus as detailed above where the protrusion on the outside of the carrier member extends around a body containing a therapeutic substance attached to the outside of the carrier member.
  • there is an assembly as detailed above including a body including a therapeutic substance, the body overmoulded on to the outside of the carrier member.
  • a boundary of the body is established by material of the electrode carrier member being deformed during the overmoulding of the body onto the outside of the carrier member. In an exemplary embodiment, this deformation is not present when the electrode carrier member is in a relaxed state. In an exemplary embodiment, this can correspond to the protrusions that are on the carrier member. In an exemplary embodiment, this can correspond to the deformation of the carrier member imparted by the protrusions in the mould cavity.
  • the portions of the carrier member and/or the protrusions of the electrode array will drag, pull, and/or push the overmoulded body that are in contact therewith from the position that the body would be in in the absence of the return from the deformed state. This will occur after the silicone has cured in the mould. Thus there will be stress risers and deformation of the body 890 relative to that which would otherwise be the case.
  • At least some exemplary embodiments results in an electrode array that can be evaluated to determine that the carrier member was deformed during the process of overmoulding.
  • the stresses and strains of the body, and also in some instances, of the carrier member, in the final product will be indicative of the manufacturing process just detailed.
  • the stress riser exists at at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of the lateral boundary of the body.
  • Embodiments thus include an assembly where the protrusion forms a closed reservoir for the therapeutic substance when the therapeutic substance is overmoulded on to the carrier member. And consistent with the teachings detailed above with respect to the protrusions inside the protrusion arrangement, in some exemplary embodiments, there are a plurality of raised areas extending above the body of which the therapeutic substance is entrained or otherwise embedded.
  • the substance that is overmoulded in method action 2830 is a substance that includes a therapeutic substance.
  • the teachings detailed herein can enable a more precise amount of therapeutic substance to be attached to the stimulating assembly relative to that which would otherwise be the case. More specifically, in an exemplary embodiment, the amount of therapeutic substance can be controlled within tighter tolerances relative to that which would otherwise be the case.
  • an amount of therapeutic substance overmoulded onto the modified cochlear implant electrode array is within plus or minus35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3 or 2% or any value or range of values therebetween in 0.1% increments of the identified amount.
  • This can have utilitarian value with respect to providing an electrode array that has a specific amount of therapeutic substance thereon, so that the release rates and/or the release amount can be better determine or otherwise better controlled.
  • the “dosage” of the therapeutic substance is desired to be controlled within a tighter manner than that which would otherwise be the case without the teachings detailed herein.
  • the tolerancing of the mould cavity and the precision process of injection moulding the therapeutic substance containing material can provide for the heightened tolerances relative to a non-automated or non-mechanical process, such as depositing the therapeutic substance by hand, utilizing a hand syringe or the like.
  • the teachings herein can provide improvements to develop a more automated process for the manufacturing of the drug eluting electrode arrays for more ease of manufacture and/or to produce more consistent parts to meet the exacting drug release specifications imposed by regulators, such as the aforementioned tolerances.
  • the drug-eluting material is thus attached to the electrode array by a non-manual procedure.
  • the basin established by the protrusions is not a well as that phrase is understood in the art with respect to a cavity or void in which to manufacture a drug-eluting cochlear implant electrode array.
  • the teachings herein explicitly exclude the concept of utilizing a so-called 2K moulding approach.
  • the material containing the therapeutic substance overmoulded on to the carrier member is not so overmoulded without first removing the carrier member from the mould that was utilized to produce the carrier member.
  • the mould in which the overmoulding takes place is not the same that was utilized to make the carrier member in the first instance. That is, embodiments include utilizing two separate moulds having different mould cavity configurations, a first to establish the cochlear implant electrode array in general, and the carrier member thereof specifically, and a second to overmoulded the therapeutic substance containing material on to the carrier member.
  • the first mould will have the contours of the resulting carrier member, with or without the protrusions, in its relaxed state.
  • the first mould will not have a gap or cavity for the therapeutic substance to be injected subsequent to the curing of the carrier member.
  • the therapeutic substance containing material is located only on one side of the carrier member.
  • the therapeutic substance containing material and/or the outermost portions of the barrier / protrusion arrangement subtends an angle no more than 145, 140, 135, 130, 125, 120, 115, 110, 105, 100, 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30 or 25 degrees or any value or range of values therebetween in 1 degree increments (of course, the values would be different for the two, as the body will be less than the outer periphery of the barrier). In an embodiment, this is the average over the length of the material (mean, median and/or mode).
  • the utilitarian value with respect to injection moulding the drug loaded silicone directly onto the carrier member can enable the aforementioned utilitarian features in at least some exemplary embodiments.
  • the teachings detailed herein can prevent the material containing the therapeutic substance from leaking or flashing to other parts the electrode array where such is not desired, such as for example, to the electrode contacts, where the flashing of the therapeutic substance containing material over the electrodes could reduce the efficacy of the electrodes after implantation into a human. Further, the flashing results in a less tolerance amount of therapeutic substance delivery material provided on a given electrode array.
  • the teachings detailed herein can enable better control of the placements, or more accurately, the resulting locationality of the resulting overmoulded body relative to that which would otherwise be the case with respect to, for example, manual depositing the therapeutic substance containing material onto the electrode array.
  • the teachings detailed above rely on structure that mimics the function of an O-ring, whether that be the protrusions that are formed on the carrier member, or whether that be the protrusions inside the mould that the form the normally shaped carrier member, or a combination of the two.
  • the idea is that the O-ring concept can be used to shut off against gas, water, etc., owing to overpressure on one side of the ring relative to the other side of the ring.
  • any disclosure herein of any method of manufacturing or otherwise developing or making a device disclosed herein corresponds to a disclosure of the resulting device that results from that method. It is noted that any disclosure herein of any apparatus and/or system corresponds to a disclosure of providing and/or making that apparatus and/or system. It is noted that any disclosure herein of any functionality corresponds to a device and/or system is configured to provide that functionality. It is noted that any disclosure of any device and/or system herein corresponds to a disclosure of a method of utilizing that device and/or system.
  • any disclosure of a device and/or system herein also corresponds to a disclosure of utilizing the device and/or system detailed herein, at least in a manner to exploit the functionality thereof.
  • any disclosure of a method of manufacturing corresponds to a disclosure of a device and/or system resulting from that method of manufacturing.
  • any disclosure of a device and/or system herein corresponds to a disclosure of manufacturing that device and/or system.

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Abstract

An assembly, including an electrode contact, an electrode carrier member, and a protrusion on an outside of the carrier member forming at least a portion of an arrangement that bounds an area on an outer surface of the carrier member on an opposite side from the electrode contact, wherein the assembly is an implantable stimulating assembly.

Description

ELECTRODE ARRAY WITH SURFACE FEATURES
CROSS-REFERENCE TO RELATED APPLICATIONS
[oooi] This application claims priority to U.S. Provisional Application No. 63/447,573, entitled ELECTRODE ARRAY WITH SURFACE FEATURES, filed on February 22, 2023, naming Peter Raymond SIBARY as an inventor. This application also claims priority to U.S. Provisional Application No. 63/449,874, entitled ELECTRODE ARRAY WITH SURFACE FEATURES, filed on March 3, 2023, naming Peter Raymond SIBARY as an inventor. The entire contents of each application being incorporated herein by reference in their entirety.
BACKGROUND
[0002] Medical devices have provided a wide range of therapeutic benefits to recipients over recent decades. Medical devices can include internal or implantable components/devices, external or wearable components/devices, or combinations thereof (e.g., a device having an external component communicating with an implantable component). Medical devices, such as traditional hearing aids, partially or fully-implantable hearing prostheses (e.g., bone conduction devices, mechanical stimulators, cochlear implants, etc.), pacemakers, defibrillators, functional electrical stimulation devices, and other medical devices, have been successful in performing lifesaving and/or lifestyle enhancement functions and/or recipient monitoring for a number of years.
[0003] The types of medical devices and the ranges of functions performed thereby have increased over the years. For example, many medical devices, sometimes referred to as “implantable medical devices,” now often include one or more instruments, apparatus, sensors, processors, controllers or other functional mechanical or electrical components that are permanently or temporarily implanted in a recipient. These functional devices are typically used to diagnose, prevent, monitor, treat, or manage a disease/injury or symptom thereof, or to investigate, replace or modify the anatomy or a physiological process. Many of these functional devices utilize power and/or data received from external devices that are part of, or operate in conjunction with, implantable components.
SUMMARY
[0004] In an exemplary embodiment, there is an apparatus, comprising a plurality of electrodes, an electrode carrier member and a raised area on an outside of the carrier member, wherein the apparatus is a cochlear implant electrode array, the plurality of electrodes are arrayed in a longitudinal direction of the cochlear implant electrode array, and the raised area extends in the longitudinal direction contiguous with at least two electrodes.
[0005] In an exemplary embodiment, there is an assembly, comprising a plurality of electrode contacts, an electrode carrier member; and a protrusion extending about at least two of the plurality of electrode contacts on an outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
[0006] In an exemplary embodiment, there is an assembly, comprising an electrode contact, electrode carrier member and a protrusion on an outside of the carrier member forming at least a portion of an arrangement that bounds an area on an outer surface of the carrier member on an opposite side from the electrode contact, wherein the assembly is an implantable stimulating assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] Embodiments are described below with reference to the attached drawings, in which:
[0008] FIG. 1A is a perspective view of an exemplary hearing prosthesis in which at least some of the teachings detailed herein are applicable;
[0009] FIGs. 1B-1D are quasi functional diagrams of an exemplary device to which some embodiments may be applicable;
[ooio] FIGs IE and 2A and 2B and 2C and IF present some schematics related to base technologies associated with some embodiments;
[ooii] FIGs. 3 and 4 show other exemplary medical devices to which at least some of the teachings herein are applicable;
[0012] FIG. 5 shows a top view of an exemplary implantable portion of a cochlear implant according to an embodiment;
[0013] FIGs. 6A-6I show features associated with an electrode array;
[0014] FIGs. 7A and 7B show how an array can curl in some embodiments;
[0015] FIGs. 8-10 show side views of an electrode array;
[0016] FIGs. 11-19A show exemplary cross-sections of an electrode array;
[0017] FIGs. 20-25 show top views of exemplary electrode arrays;
[0018] FIG. 26 is a cross-section of an array; [0019] FIG. 27 is a cross-section of an array;
[0020] FIG. 28 is a flowchart for an exemplary method;
[0021] FIGs. 29-31 and 33 show exemplary mould features; and
[0022] FIG. 32 shows a top view of a modified electrode array.
DETAILED DESCRIPTION
[0023] Merely for ease of description, the techniques presented herein are primarily described herein with reference to an illustrative medical device, namely a hearing prosthesis. First introduced is a cochlear implant. The techniques presented herein may also be used with a variety of other medical devices that, while providing a wide range of therapeutic benefits to recipients, patients, or other users, may benefit from the teachings herein used in other medical devices. For example, any techniques presented herein described for one type of hearing prosthesis, such as a cochlear implant, corresponds to a disclosure of another embodiment of using such teaching with, at least in conjunction with, another hearing prosthesis, including bone conduction devices (percutaneous, active transcutaneous and/or passive transcutaneous), middle ear auditory prostheses, direct acoustic stimulators, and also utilizing such with other electrically simulating auditory prostheses (e.g., auditory brain stimulators), etc. The techniques presented herein can be used with implantable / implanted microphones, whether or not used as part of a hearing prosthesis (e.g., a body noise or other monitor, whether or not it is part of a hearing prosthesis) and/or external microphones. The techniques presented herein can also be used with vestibular devices (e.g., vestibular implants), sensors, seizure devices (e.g., devices for monitoring and/or treating epileptic events, where applicable), sleep apnea devices, retinal implants, electroporation, etc., and thus any disclosure herein is a disclosure of utilizing such devices with the teachings herein, providing that the art enables such.
[0024] Note also embodiments include the application of the teachings herein to a medical device that is a non-implanted medical device, such as a minimally invasive probe used by medical personnel.
[0025] By way of example, any of the technologies detailed herein which are associated with components that are implanted in a recipient can be combined with information delivery technologies disclosed herein, such as for example, devices that evoke a hearing percept, to convey information to the recipient. By way of example only and not by way of limitation, a sleep apnea implanted device can be combined with a device that can evoke a hearing percept so as to provide information to a recipient, such as status information, etc. In this regard, the various sensors detailed herein and the various output devices detailed herein can be combined with such a non-sensory prosthesis or any other nonsensory prosthesis that includes implantable components so as to enable a user interface, as will be described herein, that enables information to be conveyed to the recipient, which information is associated with the implant.
[0026] While the teachings detailed herein will be described for the most part with respect to hearing prostheses, in keeping with the above, it is noted that any disclosure herein with respect to a hearing prosthesis corresponds to a disclosure of another embodiment of utilizing the associated teachings with respect to any of the other prostheses noted herein, whether a species of a hearing prosthesis, or a species of a sensory prosthesis.
[0027] The techniques presented herein are also described with reference by way of background to another illustrative medical device, namely a retinal implant. As noted above, the techniques presented herein are also applicable to the technology of vestibular devices (e.g., vestibular implants), visual devices (i.e., bionic eyes), as well as sensors, pacemakers, drug delivery systems, defibrillators, functional electrical stimulation devices, catheters, seizure devices (e.g., devices for monitoring and/or treating epileptic events), sleep apnea devices, electroporation, etc.
[0028] Any reference to one of the above-noted sensory prostheses corresponds to an alternate disclosure using one of the other above-noted sensory prostheses unless otherwise noted providing that the art enables such.
[0029] FIG. 1A is perspective view of an implantable portion of a cochlear implant 100, implanted in a recipient. The implantable portion of the cochlear implant 100 is part of a partially implantable cochlear implant system 10 that can include external component s), as will be detailed below.
[0030] The recipient has an outer ear 101, a middle ear 105, and an inner ear 107. Components of outer ear 101, middle ear 105, and inner ear 107 are described below, followed by a description of implant 100.
[0031] In a fully functional ear, outer ear 101 comprises an auricle 110 and an ear canal 102. An acoustic pressure or sound wave 103 is collected by auricle 110 and channeled into and through ear canal 102. Disposed across the distal end of ear canal 102 is a tympanic membrane 104 which vibrates in response to sound wave 103. This vibration is coupled to oval window or fenestra ovalis 112 through three bones of middle ear 105, collectively referred to as the ossicles 106 and comprising the malleus 108, the incus 109, and the stapes 111. Bones 108, 109, and 111 of middle ear 105 serve to filter and amplify sound wave 103, causing oval window 112 to articulate, or vibrate in response to vibration of tympanic membrane 104. This vibration sets up waves of fluid motion of the perilymph within cochlea 140. Such fluid motion, in turn, activates tiny hair cells (not shown) inside of cochlea 140. Activation of the hair cells causes appropriate nerve impulses to be generated and transferred through the spiral ganglion cells (not shown) and auditory nerve 114 to the brain (also not shown) where they are perceived as sound.
[0032] As shown, implantable portion of cochlear implant 100 comprises one or more components which are temporarily or permanently implanted in the recipient. Implant 100 is shown in FIG. 1A with an external device 142, that is part of system 10 (along with implantable portion of the cochlear implant 100), which, as described below, is configured to provide power to the implant.
[0033] In the illustrative arrangement of FIG. 1A, external device 142 may comprise a power source (not shown) disposed in a Behind-The-Ear (BTE) unit 126. External device 142 also includes components of a transcutaneous energy transfer link, referred to as an external energy transfer assembly. The transcutaneous energy transfer link is used to transfer power and/or data to implant 100. Various types of energy transfer, such as infrared (IR), electromagnetic, capacitive, and inductive transfer, may be used to transfer the power and/or data from external device 142 to implant 100. In the illustrative embodiments of FIG. 1A, the external energy transfer assembly comprises an external coil 130 that forms part of an inductive radio communication link. External coil 130 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire. External device 142 also includes a magnet (not shown) positioned within the turns of wire of external coil 130. It should be appreciated that the external device shown in FIG. 1A is merely illustrative, and other external devices may be used with embodiments of the present invention.
[0034] Implantable portion of the cochlear implant 100 comprises an internal energy transfer assembly 132 which may be positioned in a recess of the temporal bone adjacent auricle 110 of the recipient. As detailed below, internal energy transfer assembly 132 is a component of the transcutaneous energy transfer link and receives power and/or data from external device 142. In the illustrative embodiment, the energy transfer link comprises an inductive RF link, and internal energy transfer assembly 132 comprises a primary internal coil 136. Internal coil 136 is typically a wire antenna coil comprised of multiple turns of electrically insulated single-strand or multi-strand platinum or gold wire.
[0035] The implantable portion of the cochlear implant 100 further comprises a main implantable component 120 and an elongate stimulating assembly 118. In embodiments of the present invention, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In embodiments of the present invention, main implantable component 120 includes a sound processing unit (not shown) to convert the sound signals received by the implantable microphone in internal energy transfer assembly 132 to data signals. Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate stimulating assembly 118.
[0036] Elongate stimulating assembly 118 has a proximal end connected to main implantable component 120, and a distal end implanted in cochlea 140. Stimulating assembly 118 extends from main implantable component 120 to cochlea 140 through mastoid bone 119. In some embodiments stimulating assembly 118 may be implanted at least in basal region 116, and sometimes further. For example, stimulating assembly 118 may extend towards apical end of cochlea 140, referred to as cochlea apex 134. In certain circumstances, stimulating assembly 118 may be inserted into cochlea 140 via a cochleostomy 122. In other circumstances, a cochleostomy may be formed through round window 121, oval window 112, the promontory 123 or through an apical turn 147 of cochlea 140.
[0037] Stimulating assembly 118 comprises a longitudinally aligned and distally extending array 146 of electrodes 148, disposed along a length thereof. As noted, a stimulator unit generates stimulation signals which are applied by stimulating contacts 148, which, in an exemplary embodiment, are electrodes, to cochlea 140, thereby stimulating auditory nerve 114. In an exemplary embodiment, stimulation contacts can be any type of component that stimulates the cochlea (e.g., mechanical components, such as piezoelectric devices that move or vibrate, thus stimulating the cochlea (e.g., by inducing movement of the fluid in the cochlea), electrodes that apply current to the cochlea, etc.). Embodiments detailed herein will generally be described in terms of an electrode assembly 118 utilizing electrodes as elements 148. It is noted that alternate embodiments can utilize other types of stimulating devices. Any device, system, or method of stimulating the cochlea via a device that is located in the cochlea can be utilized in at least some embodiments. In this regard, any implantable array that stimulates tissue, such as a retinal implant array, or a spinal array, or a pacemaker array, etc., is encompassed within the teachings herein unless otherwise noted.
[0038] As noted, the implantable portion 100 comprises a partially implantable prosthesis, as contrasted to a totally implantable prosthesis that is capable of operating, at least for a period of time, without the need for external device 142. Therefore, implantable portion of cochlear implant 100 does not comprise a rechargeable power source that stores power received from external device 142, as contrasted to an embodiment where there is an implantable rechargeable power source (e.g., a rechargeable battery). During operation of implant 100, the power is transferred from the external component to the implanted component via the link, and distributed to the various other implanted components as needed.
[0039] It is noted that the teachings detailed herein and/or variations thereof can be utilized with a totally implantable prosthesis. That is, in an alternate embodiment of the cochlear implants or other hearing prostheses detailed herein, the prostheses are totally implantable prostheses, such as where there is an implanted microphone and sound processor and battery.
[0040] FIG. IB provides a schematic of an exemplary conceptual sleep apnea system 1991. Here, this exemplary sleep apnea system utilizes a microphone 12 (represented conceptually) to capture a person’s breathing or otherwise the sounds made by a person while sleeping. The microphone transduces the captured sound into an electrical signal which is provided via electrical leads 198 to the main unit 197, which includes a processor unit that can evaluate the signal from leads 198 or, in another arrangement, unit 197 is configured to provide that signal to a remote processing location via the Internet or the like, where the signal was evaluated. Upon an evaluation that an action should be taken or otherwise can be utilitarian taken by the sleep apnea system 1991, the unit 197 activates to implement sleep apnea countermeasures, which countermeasures are conducted by a hose 1902 sleep apnea mask 195. By way of example only and not by way of limitation, pressure variations can be used to treat the sleep apnea upon an indication of such an occurrence.
[0041] In an exemplary embodiment, the advanced implantation methods and devices detailed herein can be utilized to treat sleep apnea / in a device that can be used to treat. Specifically, the electrodes of the implant disclosed below can be utilized in place of the electrodes 194 (placed accordingly, of course), and the implant can be of a configuration to treat sleep apnea. In this regard, in an exemplary embodiment, the implantable components detailed herein can be located at locations to treat sleep apnea in accordance with the teachings herein, with the requisite modification if necessary or otherwise utilitarian to implement such.
[0042] FIGs. 1C and ID provide another exemplary schematic of another exemplary conceptual sleep apnea system 1992. Here, the sleep apnea system is different from that of figure IB in that electrodes 194 (which can be implanted in some embodiments) are utilized to provide stimulation to the human who is experiencing a sleep apnea scenario. FIG. 1C illustrates an external unit, and FIG. ID illustrates the external unit 120 and an implanted unit 110 in signal communication via an inductance coil 707 of the external unit and a corresponding implanted inductance coil (not shown) of the implanted unit, according to which the teachings herein can be applicable. Implanted unit 110, can be configured for implantation in a recipient, in a location that permits it to modulate nerves of the recipient 100 via electrodes 194. In treating sleep apnea, implant unit 110 and/or the electrodes thereof can be located on a genioglossus muscle of a patient. Such a location is suitable for modulation of the hypoglossal nerve, branches of which run inside the genioglossus muscle.
[0043] External unit 120 can be configured for location external to a patient, either directly contacting, or close to the skin of the recipient. External unit 120 may be configured to be affixed to the patient, for example, by adhering to the skin of the patient, or through a band or other device configured to hold external unit 120 in place. Adherence to the skin of external unit 120 may occur such that it is in the vicinity of the location of implant unit 110 so that, for example, the external unit 120 can be in signal communication with the implant unit 110 as conceptually shown, which communication can be via an inductive link or an RF link or any link that can enable treatment of sleep apnea using the implant unit and the external unit. External unit 120 can include a processor unit 198 that is configured to control the stimulation executed by the implant unit 110. In this regard, processor unit 198 can be in signal communication with microphone 12, via electrical leads, such as in an arrangement where the external unit 120 is a modularized component, or via a wireless system, such as conceptually represented in FIG. ID.
[0044] A common feature of both of these sleep apnea treatment systems is the utilization of the microphone to capture sound, and the utilization of that captured sound to implement one or more features of the sleep apnea system. In some embodiments, the teachings herein are used with the sleep apnea device just detailed. [0045] FIG. 3 presents an exemplary embodiment of a neural prosthesis in general, and a retinal prosthesis and an environment of use thereof, in particular, the components of which can be used in whole or in part, with some of the teachings herein. In some embodiments of a retinal prosthesis, a retinal prosthesis sensor-stimulator 10801 is positioned proximate the retina 11001. In an exemplary embodiment, photons entering the eye are absorbed by a microelectronic array of the sensor-stimulator 10801 that is hybridized to a glass piece 11201 containing, for example, an embedded array of microwires. The glass can have a curved surface that conforms to the inner radius of the retina. The sensor-stimulator 108 can include a microelectronic imaging device that can be made of thin silicone containing integrated circuitry that convert the incident photons to an electronic charge.
[0046] An image processor 10201 is in signal communication with the sensor-stimulator 10801 via cable 10401 which extends through surgical incision 00601 through the eye wall (although in other embodiments, the image processor 10201 is in wireless communication with the sensor-stimulator 10801). The image processor 10201 processes the input into the sensor-stimulator 10801 and provides control signals back to the sensor-stimulator 10801 so the device can provide processed output to the optic nerve. That said, in an alternate embodiment, the processing is executed by a component proximate with or integrated with the sensor-stimulator 10801. The electric charge resulting from the conversion of the incident photons is converted to a proportional amount of electronic current which is input to a nearby retinal cell layer. The cells fire and a signal is sent to the optic nerve, thus inducing a sight perception.
[0047] The retinal prosthesis can include an external device disposed in a Behind-The-Ear (BTE) unit or in a pair of eyeglasses, or any other type of component that can have utilitarian value. The retinal prosthesis can include an external light / image capture device (e.g., located in / on a BTE device or a pair of glasses, etc.), while, as noted above, in some embodiments, the sensor-stimulator 10801 captures light / images, which sensor-stimulator is implanted in the recipient.
[0048] In the interests of compact disclosure, any disclosure herein of a microphone or sound capture device corresponds to an analogous disclosure of a light / image capture device, such as a charge-coupled device. Corollary to this is that any disclosure herein of a stimulator unit which generates electrical stimulation signals or otherwise imparts energy to tissue to evoke a hearing percept corresponds to an analogous disclosure of a stimulator device for a retinal prosthesis. Any disclosure herein of a sound processor or processing of captured sounds or the like corresponds to an analogous disclosure of a light processor / image processor that has analogous functionality for a retinal prosthesis, and the processing of captured images in an analogous manner. Indeed, any disclosure herein of a device for a hearing prosthesis corresponds to a disclosure of a device for a retinal prosthesis having analogous functionality for a retinal prosthesis. Any disclosure herein of fitting a hearing prosthesis corresponds to a disclosure of fitting a retinal prosthesis using analogous actions. Any disclosure herein of a method of using or operating or otherwise working with a hearing prosthesis herein corresponds to a disclosure of using or operating or otherwise working with a retinal prosthesis in an analogous manner.
[0049] Figure 4 depicts an exemplary vestibular implant 400 according to one example. Some specific features are described utilizing the above-noted cochlear implant of figure 1 in contacts for the various elements. In this regard, some features of a cochlear implant are utilized with vestibular implants. In the interest of textual and pictorial economy, various elements of the vestibular implant that generally correspond to the elements of the cochlear implant above are referenced utilizing the same numerals. Still, it is noted that some features of the vestibular implant 400 will be different from that of the cochlear implant above. By way of example only and not by way of limitation, there may not be a microphone on the behind-the-ear device 126. Alternatively, sensors that have utilitarian value in the vestibular implant can be contained in the BTE device 126. By way of example only and not by way of limitation, motion sensors can be located in BTE device 126. There also may not be a sound processor in the BTE device. Conversely, other types of processors, such as those that process data obtained from the sensors, will be present in the BTE device 126. Power sources, such as a battery, will also be included in the BTE device 126. Consistent with the BTE device of the cochlear implant of figure 1, a transmitter / transceiver will be located in the BTE device or otherwise in signal communication therewith. Any one or more of the teachings herein can be used with the arrangement of FIG. 4.
[0050] The implantable component includes a receiver-stimulator in a manner concomitant with the above cochlear implant. Here, the vestibular stimulator comprises a main implantable component 120 and an elongate electrode assembly 14188 (where the elongate electrode assembly 14188 has some different features from the elongate electrode assembly 118 of the cochlear implant, some of which will be described shortly). In some embodiments, internal energy transfer assembly 132 and main implantable component 120 are hermetically sealed within a biocompatible housing. In some embodiments, main implantable component 120 includes a processing unit (not shown) to convert data obtained by sensors, which could be on board sensors implanted in the recipient, into data signals.
[0051] Main implantable component 120 further includes a stimulator unit (also not shown) which generates electrical stimulation signals based on the data signals. The electrical stimulation signals are delivered to the recipient via elongate electrode assembly 14188.
[0052] It is briefly noted that while the embodiment shown in figure 4 represents a partially implantable vestibular implant, embodiments can include a totally implantable vestibular implant, such as, where, for example, the motion sensors are located in the implantable portion, in a manner analogous to a cochlear implant.
[0053] Elongate electrode assembly 14188 has a proximal end connected to main implantable component 120, and extends through a hole in the mastoid 119, in a manner analogous to the elongate electrode assembly 118 of the cochlear implant, and includes a distal end that extends to the inner ear. In some embodiments, the distal portion of the electrode assembly 14188 includes a plurality of leads 410 that branch out away from the main body of the electrode assembly 118 to electrodes 420. Electrodes 420 can be placed at the base of the semicircular ducts as shown in figure 4. In an exemplary embodiment, one or more of these electrodes are placed in the vicinity of the vestibular nerve branches innervating the semicircular canals. In some embodiments, the electrodes are located external to the inner ear, while in other embodiments, the electrodes are inserted into the inner ear. Note also while this embodiment does not include an electrode array located in the cochlea, in other embodiments, one or more electrodes are located in the cochlea in a manner analogous to that of a cochlear implant.
[0054] Returning back to hearing prosthesis devices, and in particular a cochlear implant, FIG. IE is a side view of the internal component (implantable component) of cochlear implant 100 without the other components of system 10 (e.g., the external components). The implantable portion of cochlear implant 100 comprises a receiver/stimulator 180 (combination of main implantable component 120 and internal energy transfer assembly 132) and a stimulating assembly or lead 118. Stimulating assembly 118 includes a helix region 182, a transition region 184, a proximal region 186, and an intra-cochlear region 188. Proximal region 186 and intra-cochlear region 188 form an electrode array assembly 190. In an exemplary embodiment, proximal region 186 is located in the middle-ear cavity of the recipient after implantation of the intra-cochlear region 188 into the cochlea. Thus, proximal region 186 corresponds to a middle-ear cavity sub-section of the electrode array assembly 190. Electrode array assembly 190, and in particular, intra-cochlear region 188 of electrode array assembly 190, supports a plurality of electrode contacts 148. These electrode contacts 148 are each connected to a respective conductive pathway, such as wires, PCB traces, etc. (not shown) which are connected through lead 118 to receiver/stimulator 180, through which respective stimulating electrical signals for each electrode contact 148 travel.
[0055] FIG. 2A is a side view of electrode array assembly 190 in a curled orientation, as it would be when inserted in a recipient's cochlea, with electrode contacts 148 located on the inside of the curve. FIG. 2A depicts the electrode array of FIG. IB in situ in a patient's cochlea 140.
[0056] FIG. 2B depicts a side view of a device 390 corresponding to a cochlear implant electrode array assembly that can include some or all of the features of electrode array assembly 190 of FIG. IE. More specifically, in an exemplary embodiment, stimulating assembly 118 includes electrode array assembly 390 instead of electrode array assembly 190 (i.e., 190 is replaced with 390).
[0057] Electrode array assembly 390 includes a cochlear implant electrode array componentry of the 190 assembly above. Note also element 310, which is a quasi-handle like device utilized with utilitarian value vis-a-vis inserting the 188 section into a cochlea. By way of example only and not by way of limitation, element 310, which is a silicone body that extends laterally away from the longitudinal axis of the electrode array assembly 390, and has a thickness that is less than that of the main body of the assembly (the portion through which the electrical leads that extend to the electrodes extend to the elongate lead assembly 302). The thickness combined with the material structure is sufficient so that the handle can be gripped at least by a tweezers or the like during implantation and by application of a force on to the tweezers, the force can be transferred into the electrode array assembly 390 so that section 188 can be inserted into the cochlea.
[0058] FIG. 2C presents additional details of an external component assembly 242, corresponding to external component 142 above. It is noted that in a modified form, this device can be used with the other prostheses herein (e.g., some such embodiments might not have the ear piece 250).
[0059] External assembly 242 typically comprises a sound transducer 220 for detecting sound, and for generating an electrical audio signal, typically an analog audio signal. In this illustrative arrangement, sound transducer 220 is a microphone. In alternative arrangements, sound transducer 220 can be any device now or later developed that can detect sound and generate electrical signals representative of such sound. An exemplary alternate location of sound transducer 220 will be detailed below. As will be detailed below, a sound transducer can also be located in an ear piece, which can utilize the “funneling” features of the pinna for more natural sound capture (more on this below).
[0060] External assembly 242 also comprises a signal processing unit, a power source (not shown), and an external transmitter unit. External transmitter unit 206 (sometimes herein referred to as a headpiece) comprises an external coil 208 and, a magnet (not shown) secured directly or indirectly to the external coil 208. The signal processing unit processes the output of microphone 220 that is positioned, in the depicted arrangement, by outer ear 201 of the recipient. The signal processing unit generates coded signals using a signal processing apparatus (sometimes referred to herein as a sound processing apparatus), which can be circuitry (often a chip) configured to process received signals - because element 230 contains this circuitry, the entire component 230 is often called a sound processing unit or a signal processing unit. These coded signals can be referred to herein as a stimulation data signals, which are provided to external transmitter unit 206 via a cable 247. In this exemplary arrangement of figure ID, cable 247 includes connector jack 221 which is bayonet fitted into receptacle 219 of the signal processing unit 230 (an opening is present in the dorsal spine, which receives the bayonet connector, in which includes electrical contacts to place the external transmitter unit into signal communication with the signal processor 230). It is also noted that in alternative arrangements, the external transmitter unit is hardwired to the signal processor subassembly 230. That is, cable 247 is in signal communication via hardwiring, with the signal processor subassembly. (The device of course could be disassembled, but that is different than the arrangement shown in figure ID that utilizes the bayonet connector.) Conversely, in some embodiments, there is no cable 247. Instead, there is a wireless transmitter and/or transceiver in the housing of component 230 and/or attached to the housing (e.g., a transmitter / transceiver can be attached to the receptacle 219) and the headpiece can include a receiver and/or transceiver, and can be in signal communication with the transmitter / transceiver of / associated with element 230.
[0061] FIG. IF provides additional details of an exemplary in-the-ear (ITE) component 250. The overall component containing the signal processing unit is, in this illustration, constructed and arranged so that it can fit behind outer ear 201 in a BTE (behind-the-ear) configuration, but may also be worn on different parts of the recipient's body or clothing.
[0062] In some arrangements, the signal processor (also referred to as the sound processor) may produce electrical stimulations alone, without generation of any acoustic stimulation beyond those that naturally enter the ear. While in still further arrangements, two signal processors may be used. One signal processor is used for generating electrical stimulations in conjunction with a second speech processor used for producing acoustic stimulations.
[0063] As shown in FIG. IF, an ITE component 250 is connected to the spine of the BTE (a general term used to describe the part to which the battery 270 attaches, which contains the signal (sound) processor and supports various components, such as the microphone - more on this below) through cable 252 (and thus connected to the sound processor / signal processor thereby). ITE component 250 includes a housing 256, which can be a moulding shaped to the recipient. Inside ITE component 250 there is provided a sound transducer 220 that can be located on element 250 so that the natural wonders of the human ear can be utilized to funnel sound in a more natural manner to the sound transducer of the external component. In an exemplary arrangement, sound transducer 242 is in signal communication with remainder of the BTE unit via cable 252, as is schematically depicted in figure IF via the sub cable extending from sound transducer 242 to cable 252. Shown in dashed lines are leads 21324 that extend from transducer 220 to cable 252. Not shown is an air vent that extends from the left side of the housing 256 to the right side of the housing (at or near the tip on the right side) to balance air pressure “behind” the housing 256 and the ambient atmosphere when the housing 256 is in an ear canal.
[0064] Also, FIG. 2C shows a removable power component 270 (sometimes battery back, or battery for short) directly attached to the base of the body / spine 230 of the BTE device. As seen, the BTE device in some embodiments includes control buttons 274. The BTE device may have an indicator light 276 on the earhook to indicate operational status of signal processor. Examples of status indications include a flicker when receiving incoming sounds, low rate flashing when power source is low or high rate flashing for other problems.
[0065] In one arrangement, external coil 130 transmits electrical signals to the internal coil via an inductance communication link. The internal coil is typically a wire antenna coil comprised of at least one, or two or three or more turns of electrically insulated single-strand or multi-strand platinum or gold wire. The electrical insulation of the internal coil is provided by a flexible silicone moulding (not shown). In use, internal receiver unit may be positioned in a recess of the temporal bone adjacent to outer ear 101 of the recipient.
[0066] With the above as a primer (the above should be considered base technologies from which we build upon, and are not part of the invention, but the teachings below can use any one or more of these features in some embodiments, providing that the art enables such), embodiments are directed to cochlear implants and other implants that, in some embodiments, utilize one or more of the teachings above, albeit modified in at least some instances, to practice the teachings herein.
[0067] FIG. 5 shows an implantable portion 500 of the cochlear implant, corresponding to portion 100 of figure 1A detailed above. In this regard, the features detailed above with respect to the cochlear implants are included in this embodiment. Element 181 corresponds to the RF antenna that receives transcutaneous magnetic inductive signals from the external component. The antenna 181 is in signal communication with electronics located in housing 185. Housing 185 is a hermetically sealed titanium housing that includes componentry of the cochlear implant that is configured to receive signals from the antenna 181 and, based on those signals, output signals to the electrodes of the electrode assembly 590, which can correspond to the electrode assembly 190 detailed above. Collectively, the electronics in the housing 185 and the antenna 181 establish a receiver-stimulator assembly 580, which can correspond to the receiver-stimulator assembly 180 detailed above. The antenna 181 and the housing 185 are located within a silicone body 183 that has been moulded about those components. The electrode assembly 590 is in signal communication with the electronics of the housing 185 via lead assembly 589. The lead assembly can be a silicone body that is moulded about electrical leads that run from the electrodes to a feedthrough that interfaces with the housing 185 to enable signal communication from the electronics in the housing to the electrical leads and thus to the electrodes. The electrode assembly, and in particular, the silicone body thereof, can be made separate from the silicone body that envelops the housing 185. In this regard, in an exemplary embodiment, the lead assembly 589 along with the electrode array assembly 590 is connected to the housing 185, or more accurately, the lead wires of the lead assembly 589 are first attached to a feedthrough that interfaces with the housing 185, thus placing the lead assembly into electrical signal communication with the receiver-stimulator assembly 580, which lead wires are supported by the silicone body that envelops the lead wires of the lead assembly 589. Then, silicone is moulded about the housing 185 to form the silicone body 183, which silicone body traps or otherwise adheres the lead assembly 589 to the silicone body.
[0068] FIG. 6A depicts a conceptual side view of a portion of electrode array 146, depicting four electrode contacts 148 evenly spaced along a longitudinal axis of the electrode array 146. It is noted that in some alternate embodiments, the electrode is not evenly spaced. Figure 2B depicts a conceptual cross-sectional view through one of the electrode contacts 148, which also depicts the carrier 149 of the electrode contact 148. In an exemplary embodiment, the carrier 149 is made of silicone. Not depicted in the figures are electrical leads and stiffener components that are sometimes embedded in the carrier 149. The embodiment of figure 6B represents an electrode array 146 that has a generally rectangular cross-section. Figure 6C depicts an alternate embodiment where the electrode array 146 has a generally circular cross-section. It is also noted that in some exemplary embodiments, the cross-section is oval shaped. Thus, the embodiment of FIG. 6C is a species of the genus of an electrode array having a generally continuously curving cross-section. Any electrode array of any cross-section or any configuration can be utilized with the teachings detailed herein.
[0069] The electrode contacts 148 depicted in figures 6A-6C are so-called flat contacts. In this regard, the surface of the electrode contact that faces the wall of the cochlea / the faces away from the longitudinal axis of the electrode array 146 is flat. Conversely, as seen in figures 6D-6H, in some alternate embodiments, the electrode contacts 148 are so-called half band electrodes. In some exemplary embodiments, a band of contact material is “smashed” or otherwise compressed into a “half band,” as seen in the figures. It is noted that by “half band,” this does not mean that the electrode contact must necessarily span half of the outside diameter of the electrode array, as is the case in FIGs. 6G and 6H. The term is directed towards the configuration of the electrode itself as that term has meaning in the art. Any electrode contact that can have utilitarian value according to the teachings detailed herein can be utilized in at least some exemplary embodiments.
[0070] As can be seen from FIGs. 6A-6H, the positioning of the electrode contacts relative to the carrier 149 can vary with respect to alignment of the outer surface of the carrier with the outer surface of the contact. For example, figures 6A, 6E, and 6F depict the outer surface of the contacts 148 as being flush with the outer surface of the carrier 149. Conversely, figures 6C and 6G depict the contact 148 as being recessed with respect to the outer surface of the carrier 149, while figure 6H depicts the contact 148 as being proud relative to the outer surface of the contact 149. It is noted that these various features are not limited to the specific contact geometry and/or the specific carrier geometry depicted in the figures, and that one or more features of one exemplary embodiment can be combined with one or more features of another exemplary embodiment. For example, while figure 2H depicts a half band contact as being proud of the carrier 149 having a generally circular cross-section, a flat electrode such as that depicted in figure 2 A can be proud of the carrier as well. FIG. 61 depicts a carrier with tapered sides and rounded edges. As seen, aside from FIG. 61, each carrier symmetric about the X and Y axis, and each carrier has sides that are contoured and extend in a fashion where there is no inversion of direction within a quadrant of an X and Y axis.
[0071] FIGS. 7A and 7B are side and perspective views, respectively, of representative electrode assembly 145. As noted, electrode assembly 145 comprises an electrode array 146 of electrode contacts 148. Electrode assembly 145 is configured to place electrode contacts 148 in close proximity to the ganglion cells in the modiolus. Such an electrode assembly, commonly referred to as a perimodiolar electrode assembly, is manufactured in a curved configuration as depicted in FIGS. 7 A and 7B. When free of the restraint of a stylet or insertion guide tube, electrode assembly 145 takes on a curved configuration due to it being manufactured with a bias to curve, so that it is able to conform to the curved interior of cochlea 140. As shown in FIG. 7B, when not in cochlea 140, electrode assembly 145 generally resides in a plane 350 as it returns to its curved configuration. That said, it is noted that the teachings detailed herein and/or variations thereof can be applicable to a so-called straight electrode array, which electrode array does not curl after being free of a stylet or insertion guide tube etc., but instead remains straight.
[0072] The perimodiolar electrode assembly 145 of FIGs. 7A and 7B is pre-curved in a direction that results in electrode contacts 148 being located on the interior of the curved assembly, as this causes the electrode contacts to face the modiolus when the electrode assembly is implanted in or adjacent to cochlea 140.
[0073] Embodiments can include non-perimodiolar arrays, such as lateral wall arrays.
[0074] It is also noted that while the embodiments of figures 7A-7B have been presented in terms of a so-called non-tapered electrode array (where the cross-sections of the array on a plane normal to the longitudinal axis at various locations along the longitudinal axis (e.g. in between each electrode (or a majority of the electrodes), in the middle of each electrode (or a majority of the electrodes) etc.) have generally the same cross-sectional area and shape), in an alternate embodiment, the teachings detailed herein can be applicable to a so-called tapered electrode, where the cross-sectional areas on planes taken normal to the longitudinal axis decrease with location towards the distal end of the electrode array.
[0075] As noted, in some embodiments, the electrode assembly 145 is biased to curl and will do so in the absence of forces applied thereto to maintain the straightness. That is, electrode assembly 145 has a memory that causes it to adopt a curved configuration in the absence of external forces. In an embodiment configured to be implanted in scala tympani of the cochlea, electrode assembly 145 is pre-curved to have a radius of curvature that approximates and/or is less than the curvature of medial side of the scala tympani of the cochlea. Such embodiments of the electrode assembly are referred to as a perimodiolar electrode assembly, and this position within cochlea 140 is commonly referred to as the perimodiolar position. In some embodiments, placing electrode contacts in the perimodiolar position provides utility with respect to the specificity of electrical stimulation, and can reduce the requisite current levels thereby reducing power consumption.
[0076] FIG. 8 presents an exemplary electrode array 849 according to an exemplary embodiment. Unlike the array’s detailed above, this electrode array has a carrier 849 that includes a protrusion arrangement 810. This protrusion arrangement 810 extends laterally and longitudinally. With respect to figure 9, the protrusion arrangement 810 includes two laterally extending portion portions 830 and 860, and to longitudinally extending protrusion portions 820 and 825 (see FIG. 11, the protrusion portion 825 being on the far side of the carrier in FIG. 8 and thus eclipsed). In this exemplary embodiment, the protrusion arrangement 810 extends from a location distal of the electrode E6 to a location just proximal of electrode E20 (where the electrodes are sequentially numbered starting from El, which is the most proximal (basal) and ending at E22, which is the most distal (apical). Figures 9 and 10 show more close-up views of the electrode assembly 849 and the protrusion arrangement 810. Figures 11 to 13 and 15-18 show cross-sections as indicated.
[0077] In an embodiment, the protrusion arrangement can begin over or proximal to or distal to any one of electrodes El, E2, E3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 or E22 and can end over or proximal or distal to any one of electrodes El, E2, E2, E3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, E21 or E22. And note that this is with respect to when the electrode array is in a straight orientation although this can also be the case if curvature is taken into account, in which case the aforementioned alignments are in relation to the normal direction relative to the local direction of the longitudinal. In an embodiment, each electrode is spaced from the other by a distance of less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75 or 3 mm or any value or range of values therebetween in 0.01 mm increments (from the center of each electrode or from the closest points of each electrode), and the spacing need not be the same. Note that not all embodiments have 22 electrodes. Some embodiments have more electrodes in some embodiments of less electrodes. Embodiments include an assembly or an apparatus that includes at least one and less than or greater than or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, or any value or range of values in 1 increment or more electrodes, and the protrusion / protrusion arrangement can extend in a manner that follows the pattern just detailed above.
[0078] And note further that there can be more than one protrusion arrangement on the electrode array. By way of example only and not by way of limitation, there can be one, two, three, four, five, six, seven, eight, or any value or range of values therebetween in one increment or more protrusion arrangements on the electrode array. In the embodiments, the protrusion portions form an enclosed area 840. In this regard, the protrusion portions form a single endless protrusion (analogous to an endless belt for a conveyor belt). That is, there is no gap or beginning or end of the protrusion that forms the protrusion arrangement. By way of example only and not by way of limitation, at least a portion of the outer cross-section of the protrusion is the same along the entire length (the base portions may be different depending on location - more on this below). That said, in an exemplary embodiment, there could be distinct protrusions from other protrusions that form the arrangement. By way of example only and not by way of limitation, the ends of the longitudinal portions could blend into a cylindrical structure somewhat analogous to a flanking tower of a castle, where a castle wall (analogous to a protrusion) extends between two such towers. Accordingly, in an exemplary embodiment, there could be four cylindrical structures or dome structures or circular bumps, one each at the beginning and end of each of the longitudinal protrusion portions and thus on each at the beginning and end of each of the lateral protrusion portions.
[0079] By enclosed area, as that phrase is used herein, it refers to the area that results if the outer boundary of the electrode was flattened. By rough analogy, the surface of the Earth is spherical and it is common to talk in terms of boundaries in enclosed areas with respect to geographic features, but the surface of the Earth is typically superimposed onto a flat map. For example, the “boundaries” of the main large body of the Australian continent bound all the landmass therein, but in reality, those boundaries are locations that are on a curved surface, but reference is made thereto with respect to the “flattened” surface. In the same vein, the protrusion arrangement encloses the area therein, even though that enclosed area has portions that are above the uppermost portions of some of the protrusion portions such as is the case with respect to most of the longitudinal protrusion portions 820 when viewed from the side, as shown in figure 8.
[0080] If the protrusion arrangement 810 was broken for example, where there was an area where there was no protrusion, and thus there would be a valley through the protrusion arrangement from the inside of the area 840 to the outside of the area 840, that area would no longer be enclosed, but instead would be a bounded area (if there was some protrusion portion that was always present, even if such was lower than adjacent protrusion portions, that would still be an enclosed area). And the area 840 which has been described in terms of an enclosed area is also a bounded area. Note further that while the embodiments depicted in figure 8 show the enclosed area on only one “hemisphere” of the electrode array and not extending into the opposite hemisphere (in that it does not extend past 180 degrees about the longitudinal axis of the electrode array - with respect to the coordinate system of FIG. 13 below, the top hemisphere would extend from 90 degrees to 270 degrees, and the bottom from 270 to 90 degrees), in other embodiments, the enclosed area could so extend, or at least the protrusion arrangement that establishes such could so extend.
[0081] Note also that embodiments can include the protrusion arrangements located on the electrode side of the array instead of or in addition to the protrusion arrangements being located on the dorsal or opposite side from the electrodes.
[0082] Figures 8-18 and other figures are to scale. Note that embodiments include variations of these dimensions / the relations of the various dimensions.
[0083] As seen with respect to figure 13, the protrusions are contoured with the overall body of the carrier member, and in embodiments, the protrusions are monolithic with the remainder of the carrier member. In an exemplary embodiment, the carrier member is made of biocompatible silicone such as one with a shore A durometer value of 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75 or 80 or any value or range of values therebetween in 1 increment. In an embodiment, the silicone is the standard silicone that is utilized for cochlear implants arrays (straight or perimodi olar) by the Cochlear Limited Company as permitted by the Food and Drug Administration in the United States of America in the year 2022, and/or as permitted by the pertinent regulatory body in the European Union and/or the United Kingdom and/or the Federal Republic of Germany and/or the Republic of France and/or as permitted by the pertinent regulatory body in the People’s Republic of China all in the year 2022 (which includes the material used in prior permits it continued into the year 2022).
[0084] Still with reference to figure 8, in an exemplary embodiment, there are segmented protrusions 850 located within the enclosed area formed by the protrusion arrangement 810. In this exemplary embodiment, there are 10 protrusions of various sizes, each distinct protrusion from the other. In an exemplary embodiment, there can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30, or any value or range of values therebetween in one increment or more segmented protrusions inside the enclosed area. More on this below, including some variations thereof.
[0085] Note that in the interests of clarification, the segmented protrusions 850 are not to be confused with the overall contour of the electrode array that would otherwise exist in the absence of a variation of the outer body of the carrier member. In this regard, irrespective of the presence of the protrusions, the top of the carrier member at the locations associated with the protrusions, at least with respect to the longitudinal directions of the protrusions, is different than that which is the case before and after the positions of the longitudinal protrusions. In this regard, as will be detailed below, an overmoulded body is overmoulded onto the carrier member. This is body 890. In an exemplary embodiment, the top of the carrier member is provided with a planar portion of surface 840 in some sections, the planar portion of surface 840 extends from one side of the carrier member to the other side of the carrier member, such as seen in figure 14. These tend to be the more apical cross-sections of the electrode array. Conversely, with respect to portions located away from the apical portions towards the basal and the electrode, a planar portion of surface 840 is present, in fact, two planar portions are present, but surface 840 also includes a portion that rises above those planar portions. This is seen in figure 13. Thus, surface 840 can include a planar portion 8498, and a riser portion 8499, as seen in FIG. 13. Note that the riser portion is not to be confused with the segmented protrusions 850 detailed herein. The riser portion 8499 is simply a portion of the carrier member that would otherwise exist but for the presence of the reduced area at the top, which reduced area is used to make room for the overmoulded body 890. Arguably, the riser portion 8499 can be considered a protrusion in its own right. However, this portion is not segmented like the segmented protrusions 850. In some embodiments, this riser portion 8499 is not present. In some embodiments, it is present. As will be detailed herein, in some embodiments, this provides for dimensional stability of the electrode array, and/or can be sized and dimensioned to control the ultimate volume of the overmoulded material 890, where the greater volume of the riser 8499, the less volume of the overmoulded material 890. And as can be seen from the figures, the riser portion 8499 is not extend the full length of the longitudinal protrusions, although it could in some embodiments. In this regard, by comparison the cross-section shown, it can be seen how the riser gradually descends into the main portion of the carrier member with position in the apical direction, and that ultimately becomes nonexistent for a portion of the distance along the longitudinal protrusions.
[0086] Note that in some embodiments, this riser is not present at all. The riser portion can extend for the distance of the longitudinal protrusions and/or a sub- distance thereof, such as a distance that is one or two or three or four or five or six or seven or eight or nine or 10 or 11 electrodes less than the distance specified above. In an exemplary embodiment, the riser portion extends less than, greater than or equal to 100, 90, 80, 70, 60, 50, 40, 30, 20, or 10%, or any value or range of values therebetween in 1% increments than the distances specified herein for the extension of the longitudinal portion or otherwise the protrusion arrangement 810. And note that these values are not linked per se to the distance of extension of the protrusion arrangement or the longitudinal protrusions. These values are simply given in terms of textual economy so as to not repeat some of the measurements above that are applicable, albeit in a modified manner, to the riser portion 8499.
[0087] Note further that while the planar level portions 8498 are shown, in an embodiment, these can be tapered or otherwise angled. And these surfaces could also be curved. Indeed, the riser portion 8499 could be curved from one side to the other, and there might be no planar portions 8498.
[0088] Thus, it can be seen that in an exemplary embodiment, there is an assembly, such as an implantable stimulating assembly, such as a cochlear implant electrode array, comprising an electrode contact (or a plurality of such) and an electrode carrier member. The assembly further includes a protrusion on an outside of the carrier member. In an embodiment, the protrusion on the outside of the carrier member extends to enclose an area on the carrier member. In an embodiment, the protrusion on the outside of the carrier member forms at least a portion of an arrangement that bounds an area on an outer surface of the carrier member. In an embodiment, the bounded area is an enclosed area. By way of example only and not by way of limitation, figures 20 and 21, which are views looking downward on the top of the electrode array where the electrodes are on the opposite side, and thus looking downward on to the bounded areas, show exemplary respective boundary arrangements 810. In the embodiment of figure 20, there are the “flanking towers” that are located at the ends of the elongate protrusions, and thus there are four elongate protrusions and four other protrusions. Collectively, the four elongate protrusions and the four other protrusions enclose an enclosed area. In the embodiment of figure 21, the protrusion extends all the way around the enclosed area. Note also that in the embodiment of figure 21, the protrusion extends outboard a bit with respect to the rest of the body of the carrier. This is reflected in the dashed lines of figure 21. And note that while the embodiment of figure 21 shows both the longitudinally extending protrusions being so outboard along the entire length, in another embodiment, it is only along a portion of the length that is outboard, as seen in figure 22. And consistent with the concept of multiple protrusion arrangements, figure 23 shows two protrusion arrangements located on the dorsal side, the protrusion arrangements spaced apart from each other. Also as can be seen, the protrusion arrangement on the left is completely in board of the outer profile of the general carrier body when viewed from the top, while the protrusion arrangement on the right has the longitudinal portions outboard of the general carrier body/the rest of the carrier body. And while these protrusion arrangements are spaced apart from each other, in an embodiment, they can be in direct contact with each other. Indeed, in an exemplary embodiment, the protrusion arrangements can share a lateral portion. This is seen in figure 24.
[0089] The embodiment of FIG. 20 has at least four elongate portions. The protrusion follows a path with at least four elongate portions. In an embodiment, the protrusion has at least two longitudinally extending elongate portions. And with respect to the phrase longitudinally extending, the portions do not have to extend perfectly parallel to the longitudinal axis. As long as the major direction of travel is in the longitudinal direction, that is longitudinally extending. Accordingly, the embodiment of figure 22 includes longitudinally extending elongate portions, even though those portions extend at a slightly oblique angle relative to the longitudinal direction of the overall carrier member.
[0090] In an embodiment, the bounded area has one or more channels (1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15, or any value or range of values therebetween in 1 increment, or more) from the area to the outside the area. In an embodiment, the protrusion on the outside of the carrier member extends to enclose an area on the carrier member (it is an endless protrusion - and note that the protrusion can have a varying cross-section / outer shape, at least at the locations where it changes direction (e.g., to extend laterally instead of longitudinally, etc.)).
[0091] In an embodiment, the assembly or apparatus includes a value noted above of the number of electrodes (call it X), and these electrodes extend along a length of the carrier member. The electrode can have at least Y (which can equal X, or be less than X), and with respect to location along a longitudinal axis of the carrier member, the barrier extends past the at least Y electrodes. In the embodiment of FIG. 8, the barrier extends past at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13 electrodes (because the barrier extends from one side to the other of such electrodes - if the barrier stopped over an electrode (if E5 was a bit more to the right for example), the barrier would be contiguous with respect to the longitudinal axis with at least 14 electrodes (or at least 13, or at least 12, or 11, etc.)
[0092] In an embodiment, there is an assembly, such as the implantable stimulating assemblies detailed herein, or other such devices, which assembly includes a plurality of electrode contacts and an electrode carrier member. There is a barrier extending about a plurality of electrode contacts, the plurality of electrode contacts being on an outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
[0093] An embodiment also includes an apparatus, comprising a plurality of electrodes, and an electrode carrier member. The apparatus includes a raised area on an outside of the carrier member, wherein the apparatus is a stimulating apparatus, such as a cochlear implant electrode array, the plurality of electrodes are arrayed in a longitudinal direction of the cochlear implant electrode array, and the raised area extends in the longitudinal direction contiguous with at least two electrodes (and this can mean that the raised area does not extend past any electrodes, or extends past one or two electrodes).
[0094] In an embodiment, the plurality of electrodes includes at least any number of electrodes detailed above (2, 22, 60, etc., these numbers are not repeated here for purposes of textual economy) arrayed along the longitudinal direction (and again, this not need be exactly parallel to the longitudinal direction). This number can be Z. With respect to location along the longitudinal direction, the barrier extends past the at least Z electrodes.
[0095] Consistent with the teachings above, the raised area includes a first section and a second section spaced away from the first section, both the first section and the second section extending in the longitudinal direction. This can be longitudinal portions 820 and 825, respectively. In an embodiment, the apparatus includes a section lower than the raised area between the first section and the second section. This can be the “floor” of the enclosed area. And note that by “lower,” this means local altitude that takes into account the curvature of the outer circumference of the array. In this regard, this is analogous to an aircraft flying over Philadelphia USA at 35,000 feet not being considered to be 8,000 miles high relative to Sydney Australia. The altitude is local. Indeed, in an embodiment, the height can be measured from the geometric center of the carrier member / in a plane normal to the longitudinal axis of the carrier member.
[0096] In an embodiment, the raised area and a portion of the carrier member proximate the raised area form an elongate basin on the outside of the electrode carrier member. The portion of the carrier member proximate the raised area is the portion that is lower than the raised area or otherwise has a surface that is at a lower local altitude than the raised area.
[0097] In an embodiment, the raised area includes a third section and a fourth section spaced away from the third section, the third section linking the first and second sections at a first location and the fourth section linking the first and second sections at a second location opposite the first location relative to the longitudinal direction. The lower section is between the third section and the fourth section. In an embodiment, the third and fourth sections are portions 830 and 860 respectively. In an embodiment, there are more than four sections that make up the raised area, or at least more than four distinctly different sections (as opposed to arbitrarily dividing up the raised area - the sections enumerated herein are distinct sections and not arbitrary sections).
[0098] With respect to figure 13, it can be seen that the contours of the protrusions extend seamlessly from the regular contours of the remainder of the body of the carrier. Figure 17 presents a detailed view of a cross-section of the electrode array 846 through a portion that does not have an electrode, where only the carrier member 849 is shown, which cross-section is taken on a plane lying normal to the longitudinal axis of the electrode array. In this regard, the X and Y axes are centered on the longitudinal axis of the electrode array. The axes establish four quadrants - QI, Q2, Q3, and Q4 as shown. The outer profile of the carrier member 849, which in this portion is an unbroken body of silicone with respect to the outer periphery thereof, extends from the 12 o’clock position all the way around the longitudinal axis to return to the 12 o’clock position. There are a number of transition points with respect to the outer profile. In quadrants Q3 and Q4 are identified. Accordingly, with respect to the outer profile starting at the location where the Y axis extends through the bottom of the carrier, there is transition point Tl, where the bottom of the carrier member transitions from a linear extension to the left to a curved extension curving upwards and further to the left. This continues in a uniform manner, whether the radius of curvature is constant, or a rate of change of the radius of curvature is constant, until the transition point T2, where the curvature ceases and a linear upward direction of the outer profile begins (or the note in another embodiment, this could be a linear upward and outward profile, or a linear upward and inward profile, or a curved upward and outward or upward and inner profile, where the radius of curvature changes from that which was previously the case if the radius of curvature was constant prior thereto, or where the rate of change of the radius of curvature changes from that which was the case prior to transition point T2). As seen, at transition point Tl, the tangent plane or line of the surface takes on a negative slope and then takes on a purely vertical slope at transition point T2. Then, at transition point T3, the tangent plane or line of the surface again takes on a negative slope until transition point T4, where the surface takes on a purely vertical slope and then takes on a positive slope, where this positive slope is ever decreasing until the surface reaches the Y axis with the slope become zero. In an embodiment, the transition of the slope of the tangent plane and/or line in an abrupt manner is a transition point.
[0099] Referring to figure 17, it can be seen that at least one transition point, transition point T3, results in the surface of the carrier extending further outwards than that which was the case immediately prior thereto with respect to movement in the positive direction along the Y axis. That is, at T2, the surface stops moving outward (the absolute value of X stops increasing and remains constant) until T3. At T3, the surface begins to move outward again. All of this is as contrasted to the cross-sections of FIGs. 6A-6I above. Once the surface has stopped moving outward with increasing value of Y, the surface again does not move outward (with respect to the section to the right of the Y him axis / until reaching the maximum value of Y). While not represented in the drawings, it is noted that in an exemplary embodiment, once the surface stops moving upward, it is not moved further outward and/or downward, at least in one or two contiguous quadrants. Figure 18 shows an exemplary cross-section where the surface moves downward (at the top) after the surface has stopped moving upward with respect to movement in a clockwise fashion from the bottom of the array to the top of the array (from 6 o’clock to 12 o’clock). [ooioo] In an embodiment, referring to FIG. 17, DI can be less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 or any value or range of values therebetween in 0.01 mm increments, and D2 can be less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 or any value or range of values therebetween in 0.01 mm increments. With respect to FIG. 18, D3 (depth of the recessed portion (with respect to a side view) to receive the overmoulded body can be less than, greater than or equal to 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29 or 0.30 mm or any value or range of values therebetween in 0.005 mm increments, and the overmoulded body could be recessed below the top by -0.2, -0.15, -0.1 (meaning it could be higher), -0.05, 0, 0.025, 0.05, 0.075, 0.1, 0.125, 0.15, 0.175 or 0.2 mm or more or any value or range of values therebetween in 0.001 mm increments from the top of the carrier; D4 can be less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 mm or any value or range of values therebetween in 0.01 mm increments. The above notwithstanding, the distance from the top of protrusion portion 860 to the top of body 890 (or from the top of protrusion 830, can be less than, greater than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45 or 50 micrometers or any value or range of values therebetween in 0.1 micrometer increments.
[ooioi] With respect to FIG. 13, D55 is less than, greater than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 micrometers or any value or range of values therebetween in 0.1 micrometer increments. Note also that these values can correspond to the height of the protrusions 860 and/or 830 above line 888 (and again, the values need not be the same). Note that in an embodiment, an imaginary circle can be envisioned about the longitudinal axis of the array lying on a plane normal to the longitudinal axis, which circle extends through a beginning and/or end of a protrusion, and the just-noted values can be the furthest that the protrusion extends from the circle along a vector that extends from the longitudinal axis to that furthest location.
[00102] To round this out, with respect to FIG. 8, D41 can be less than, greater than or equal to 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54 or 55 mm or any value or range of values therebetween in 0.1 mm increments (and the values can vary depending on the number of electrodes in some embodiments).
[00103] In an embodiment, with respect to FIG. 13, D65 can be less than, greater than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32, 0.33, 0.34, 0.35, 0.36, 0.37, 0.38, 0.39, 0.40, 0.41, 0.42, 0.43, 0.44, 0.45, 0.46, 0.47 mm or any value or range of values therebetween in 0.005 mm increments. A value of rcl, the radius of curvature of the protrusion, can be less than, greater than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32 or 0.33 mm or any value or range of values therebetween in 0.005 mm increments and rc2, the radius of curvature of the lead out to the protrusion can be less than, greater than or equal to 0.25, 0.5, 0.75, 1, 1.5, or 2 or 2.5 or 3 or 4 or 5 or 6 or any value or range of values therebetween in 0.05 increments times rcl.
[00104] In an embodiment, there is a first cross-section of the electrode carrier member lying on a plane that is normal to a first axis (e.g., the longitudinal axis) of the electrode carrier member. The raised area / protrusion forms an outer periphery of a portion of the crosssection. In an embodiment, the percentage of the outer periphery formed by the protrusion is less than, equal to or greater than 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,1 6, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30%, or any value or range of values therebetween in 0.1% increments (e.g., 11.3%, 26.4%, 7.3% to 22.2%, etc.) or more. In an embodiment where the protrusion arrangement is made of multiple distinct protrusions, the value would be half any of those numbers because the noted value was for a protrusion and there would be two protrusions (the combined periphery for the two protrusions would equal those numbers).
[00105] In an embodiment, the protrusion portion begins where the outer profile of the carrier body changes in a manner inconsistent with what one would otherwise expect. Put another way, there is an analogous characterization to a sponson of an aircraft or a watercraft. The structure is part of the fuselage for example, but it is different from the areas around the sponson. It is not what one would expect with respect to the overall shape and contours of the fuselage.
[00106] In an embodiment, the beginning of the protrusion is a transition point as noted above, and the beginning is something that changes in a manner inconsistent with what one would otherwise expect. The end can also be a transition point, but the end could be at a location where the outer profile of the carrier member changes in a manner consistent with what one would expect without the protrusion. For example, referring to figure 18, the transition point that indicates the beginning of protrusion 825 with respect to location along the outer periphery the cross-section with movement in the counterclockwise direction is a transition point. The vertical linear sidewall transitions to a curved concave (with respect to the outside of the cross-section) portion, whereas one would expect the outer profile to continue going upwards and the vertical direction in a linear manner. Conversely, one would expect a curved top portion, curved from the linear vertical sidewall to curve to the top portion of the cross-section. And there is indeed a transition point where the outer profile transitions from the curved portion to the flat portion on the top. In an embodiment without the protrusions. The only difference is that the transition point is located further away from the Y axis than that which would otherwise be the case in the absence of the protrusion because the protrusion “pulls out” that transition point.
[00107] In an embodiment, the outer profile of the cross-section of the protrusion portion (as opposed to the collective protrusion on the cross-section) has a constant radius for at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of value therebetween in 1% increments. In this regard, the outer profile of the cross-section of protrusion 825 of figure 18 has a constant radius for over 50% of the outer profile thereof (it is constant for more than 3/4ths of the total outer periphery).
[00108] In the embodiment of FIG. 18, the outer periphery of the portion 825 has a convex portion and a concave portion (both relative to outside the carrier member), and only one of each. As seen, the portion 825 is bounded by two linear portions of the carrier member. And while the exemplary embodiment shown in figure 18 has the compound surface just noted, in an alternate embodiment, the portion can be established by a convex portion only. This can be established by, for example, having the protrusion extend out from the vertical side in an abrupt manner instead of the curved transition shown. The vertical side of the carrier could extend up to the beginning of the for example constant radius bulbous protrusion. And while the top portion of the protrusion 825 is shown as blending smoothly into the top surface of the carrier (the flat horizontal surface), in an embodiment, the protrusion 825 can rise above that flat surface and then extend downward meeting that flat surface and transitioning to the flat surface in an abrupt manner. That said, in an alternate embodiment, the outer periphery of the cross-section of the protrusion 825 can be a compound curve (and thus compound surface with respect to the third dimension into and out of the page (all references to a curve herein correspond to an alternate disclosure with respect to the surface as it extends into and out of the curve)) that is established by two concave portions and a convex portion in the middle. In this regard, the protrusion could rise above the top surface of the carrier (above with respect to the direction in the Y axis with respect to the planar image of figure 18 for example) and then curved back downward to that top surface with a concave curve (all references to convexity and concavity are with respect to location outside of the carrier member unless otherwise noted). And while the embodiments disclosed above reference curved outer surfaces, in an embodiment, the outer surfaces can be linear. For example, instead of the aforementioned concave curves, a linear surface could be utilized to reach the convexly curved portion and then a linear surface could be used to extend from the convexly curved portion to the top linear portion. Indeed, this is seen in FIG. 9 with respect to portion 830. There, with respect to movement in the longitudinal direction in a cross-section lying on and parallel to the longitudinal axis of the electrode array and/or the carrier member, moving from proximal to distal in the direction of the longitudinal axis, the top surface of the carrier member is straight and in some embodiments tapered, and then it transitions to the concave portion of the protrusion 830 which then transitions to the convex portion of the protrusion 830, and then transitions to a linear portion having a negative slope sloping down to the surface 840 / section 840, which then meets surface 840 at an oblique angle with respect to the cross-section, where the carrier member / surface 840 extends linearly in the proximal direction from that transition point which marks the end of the protrusion 830. Note that in an embodiment there can be a chamfer or a stress relief section or a curved portion where the protrusion meets the remainder of the carrier member/the surface 840/section 840, or otherwise an “imperfection” resulting from the moulding process, at the transition points. In an embodiment, the transition point can encompass a distance in the longitudinal direction or a distance normal to the longitudinal direction. The transition point can otherwise lie in a circle lying on a plane, where the circle has a diameter that is less than 0.25, 0.2, 0.15, 0.1, 0.05, 0.04, 0.03, 0.02 or 0.01 mm or any value or range of values therebetween in 0.005 mm increments. Thus, the concept of the transition point is measured from the beginning of the transition point to the end of the transition point. That said, the concept might otherwise be characterized as a “transition area.” [00109] In an embodiment, an entirely linear series of surfaces could be utilized. This could appear as a faceted cross-section. Any arrangement of a protrusion a raised area that can enable the teachings detailed herein can be utilized in at least some exemplary embodiments.
[oono] In an embodiment, there is a first cross-section of the electrode carrier member lying on a plane that is normal to a first axis of the electrode carrier member that includes a first portion of a teardrop outer profile of the protrusion. This can be envisioned from FIG. 9, for example. The outer profile of protrusion 830 is less than a half of a tear drop shape (half the lateral side). Moreover, the beginnings of the teardrop shape can also extend into a section that is not teardrop, again as seen in figure 9 with respect to protrusion 830. Note also that this cross-section of the carrier member can have a portion that has another partial teardrop shape / a portion of a teardrop outer profile. This can be the case with respect to protrusion 860. And with respect to the features associated with the cross-sections normal to the longitudinal axis / cross-sections through the longitudinally extending protrusions (the first axis is or is parallel to the longitudinal axis in an embodiment), in an exemplary embodiment, a second cross-section of the electrode carrier member lying on a plane that is normal to a second axis of the electrode carrier member that is normal to the first axis of the electrode carrier member includes a second partial teardrop outer profile of the protrusion him. This cross-section can also include a third partial teardrop outer profile of the protrusion him. In an embodiment, an outer profile of the second cross-section of the electrode carrier member is symmetrical about a plane lying on and parallel to the first axis. And note that the partial teardrop shape exists with respect to the portions that are “above” the proximal portions of the top of the carrier member with respect to protrusion portion 830 and the portion that are above the distal portions of the top of the carrier member with respect to protrusion portion 860. In this regard, the convex portion of the protrusions, with respect to movement from proximal to distal along the top surface of the carrier member, are at the altitude of the carrier member immediately before the beginning of the protrusion with respect to protrusion portion 830 (see 888), and are at the altitude of the carrier member immediately after the end of the protrusion with respect to the protrusion portion 860 (again, see line 888). With respect to protrusion portion 830, the portion below that altitude (below line 888) is linear and slopes downward to surface 840. The opposite is the case with respect to protrusion portion 860.
[oom] While the embodiments present a protrusion that has a portion that “blends” into the remainder of the carrier member outside the perimeter established by the protrusion arrangement / on the side opposite body 890, in some other embodiments, the blend is not present. For example, instead of the partial teardrop shape, the protrusion rises like a dome (whether a half sphere or a portion of a half sphere (in which case the base does not rise up at an immediate 90 degree angle, but rises up at a lower angle, but this is as contrasted from the teardrop / blend, which starts off at zero and then increases - the blend is the opposite of the dome, which starts off at an abrupt value and then decreases from there).
[00112] Note also that in a sense, one might consider the portions below the aforementioned altitudes to not be a portion of the protrusion, at least with respect to the portions 860 and 830. In this regard, the recessed area that is located inside the protrusion arrangement 810 would have to extend upwards to the regular surface of the carrier member. This can be done in the sloping manner as shown, or can be done in a directly vertical manner. If the carrier member then immediately transitioned to the horizontal direction, there would be no protrusion. Thus, it is the portions above line 888 that constitute the protrusion, at least with respect to the cross-sections taken on a plane parallel to and lying on the longitudinal axis.
[00113] This concept can also apply to the cross-sections of the carrier member lying on a plane normal to the longitudinal axis, but instead of altitude it is location with respect to the outboard directions. With reference to figure 13, there is line 877, which represents the baseline for the side of the carrier member without protrusion portion 820. If the line 877 represents how the carrier member would extend in the absence of the protrusions, everything outboard of that line would be the protrusion, and everything in board of that line would simply be a feature associated with establishing the recess in the top of the carrier member. Thus, the portion that extends inboard of that line could be considered not part of the protrusion. And note that these lines 877 and 888 can be ascertained by comparing the other portions of the carrier member before and after and to the sides of the protrusion portions. In this regard, referring to figure 26, this shows the cross-section of the carrier member with respect to the view of figure 13, except that there are no protrusions added to the carrier member. Only the recess portion for the surface 840 is present in this arrangement (whereas the top surface would be higher but for the lack of the recess portion). This is what the carrier member would look like without the protrusions. Accordingly, if one superimposes what the carrier member would look like without the protrusions over what the carrier member looks like with the protrusions, the difference constitutes the protrusions in this conceptual arrangement. And in the interest of further clarification, figure 27 presents the view of figure 16, except without the protrusions, where this view, because it is looking towards the proximal portion of the electrode array from the distal portion of the electrode array, shows where the carrier member is located after the recess in the top of the carrier member ends, represented by curve 8497. This aids in showing where the recess is located relative to that which would otherwise be the case. Still, the concept of taking the protrusion as the entire shape as opposed to extrapolating what would exist in the absence of the protrusion and otherwise declaring the Delta to that the protrusion is a slightly different concept than that which was explained above. This concept can be referred to as the “design protrusion,” and “design protrusion portion” and “design protrusion arrangement,” etc., and the concept discussed above in the terms presented above. And note that the segmented protrusions 850 are also not shown in the interest of clarity. Those can be present in figures 26 and 27 while still conveying the concept of how the lateral and longitudinal protrusion portions exist relative to the carrier without such. That said, the concept is also applicable to figures 26 and 27, showing how the carrier member would exist without the segmented protrusions 850.
[00114] The segmented protrusions can be considered raised sections, and thus embodiments include a plurality of raised sections located between the first and second sections, the raised sections being raised relative to the section lower than the raised area.
[00115] Consistent with the protrusion(s) being made of silicone, such as silicone rubber, the raised sections / segmented protrusions can be / are resiliently compressible. In an embodiment, the material of the raised area is as resiliently compressible as the material of the other portions of the carrier member. In an embodiment, the raised area is more readily compressible relative to other portions of the carrier member owing to the geometry of the local portions of the carrier member that make up the raised area. Still, embodiments include segmented protrusions that are monolithic with the other portions of the carrier member.
[00116] And note that while embodiments have focused on a partial teardrop shape that is less than half a teardrop shape, embodiments can utilize half a teardrop shape.
[00117] And continuing with the concept of the portions of the protrusion portion below the altitude of line 888 (or with respect to the design protrusion portion, the portions of the carrier member at the end of the protrusion), as seen in the figures, the portions below the altitude of those lines until surface 840, with respect to the side view or otherwise a crosssection lying on and parallel to the longitudinal axis of the carrier member, are flat and tapered or otherwise sloped downward from the end of the curved portion of the protrusion portion to surface 840. In an embodiment, this flat tapered surface is uniform with respect to rotational angle about the longitudinal axis until the longitudinal portions 820 and 825 are reached. In this regard, the surface 840 is a curved surface with respect to position about the longitudinal axis. But embodiments can exist where the surface 840 is flat with respect to position about the longitudinal axis (e.g., that surface increases distance from the longitudinal axis with position outboard from the center of the carrier member, whereas the curved surface can be curved around the longitudinal axis so that the points on that surface are equally distant from the longitudinal axis, at least with respect to cross-sections that are normal to the longitudinal axis). Accordingly, the “height” of the flat tapered portion would decrease with respect to location outboard of the carrier member/protrusion in some embodiments, while in other embodiments, the height would remain the same and then ultimately blend into the longitudinal portions.
[00118] It is noted that in some embodiments, the change from portion 830 to portions 820 and/or 825, and thus the change from portion 860 to portions 820 and/or 825, is gradual. FIG. 15B shows a cross-sectional view of the carrier corresponding to the view indicated in FIG. 15 A. This better shows the protrusions 825 (and 830) and 820 (and 830) than in FIG. 15. Here, the cross-sectional view is taken to show the “highest altitude” of those protrusions (greatest distance from the longitudinal axis) and/or to show the cross-section thereof at the highest altitude until the protrusion arrangement transitions to the purely longitudinal section.
[00119] Embodiments include assembly, such as a stimulating assembly, such as a cochlear implant electrode array, or retinal prosthesis array, etc., comprising a plurality of electrode contacts and electrode carrier member. This assembly further includes a barrier extending on an outside of the carrier member. In an embodiment, the barrier is established by the protrusion arrangement detailed above. In this exemplary embodiment, the barrier extends on a side of the carrier member different than the side on which the electrode contacts face (as opposed to the sides of the contacts where the contacts are U shaped, which are on sides of the side on which the electrode contacts face) or a side of the carrier member different than a side on which the centers of the electrode contacts are located (all of these are opposite the dorsal portion of the array) and/or with the carrier member in a straightened orientation (recall that the carrier member can establish the array is a pre-curved electrode array that is biased to curve in the absence of exterior forces - this feature is measured by straightening the electrode array), in a direction generally and/or substantially parallel (both of which includes parallel) to a vector extending through at least two of the electrode contacts of the plurality of electrodes and past the at least two electrodes. With respect to the former, the barrier can extend on the lateral sides of the array or on the top of the array (the dorsal portion of the array). With respect to the latter, this vector must extend through two of the electrode contacts somehow. In this regard, this vector could extend through for example the topmost proximal most portion on the left side of the electrode 7, and extends through for example the bottom most distal most portion on the right side of the electrode 8. In an embodiment, the two electrodes are the closest to electrodes of the assembly, or at least the electrodes carried by the carrier member. Electrodes of the assembly, or at least the electrodes carried by the carrier member. In an exemplary embodiment, the electrodes are within one, two, three, four, five, six, seven, eight, or nine electrodes of each other, or any value or range of values therebetween in one electrode increments, with respect to location along the longitudinal axis of the carrier or otherwise with respect to location along the established vector.
[00120] In an embodiment, instead of the aforementioned vector, the features above are present with respect to the longitudinal axis of the electrode array.
[00121] In an exemplary embodiment, the plurality of electrodes includes any of the numbers detailed above, and with respect to location along the vector (or longitudinal axis), the barrier extends past the at least number of electrodes. Note that there could be more electrodes than the at least a number of electrodes. The barrier simply must extend past that number of electrodes. In note that vector need not extend through all of those electrodes, but in some embodiments, the vector does extend through all those electrodes, at least when the carrier member is in the straightened orientation. And those electrodes could be sequential / serial in at least some exemplary embodiments.
[00122] Consistent with the embodiments above, the barrier is a monolithic part of the electrode carrier member. That said, in an embodiment, the barrier can be a separate component that is attached or otherwise overmoulded to the electrode carrier member. And note that in an embodiment, the carrier member is monolithic with respect to location along the longitudinal axis from the first electrode to the last electrode. In an embodiment, the carrier member is monolithic with respect to distance along the longitudinal axis for any one of the electrodes to any of the other electrodes detailed herein. In an exemplary embodiment by way of example, the carrier member is monolithic from electrode 1 to electrode 10, and then a second carrier member is moulded to that carrier member, which second carrier member extends from electrode 11 to electrode 17 for example. In an embodiment, the entire barrier or otherwise protrusion arrangement is monolithic. In an exemplary embodiment, one or more portions of the protrusion arrangement are separate from one or more other portions of the protrusion arrangement, separate in terms of being distinctly different components, as opposed to arbitrarily divided up or otherwise divided up with respect to location, such as is the case with respect to the embodiment of figure 8, where the protrusion portions are identified with respect to their location on the array. These are separate sections, but not separate components.
[00123] And corollary to the embodiments described above, where the barrier extends in a racetrack like shape, the barrier can be an endless barrier. And note that the phrase endless barrier does not require that the portions of the barrier be monolithic with each other. This covers a barrier that has no true beginning and no true end. This is analogous to a conveyor belt for example, which is sometimes referred to as an endless belt.
[00124] In an embodiment, the carrier member is an elongate carrier member.
[00125] Consistent with the teachings detailed above, the barrier bounds and/or surrounds a lower area relative to the barrier. This concept of the lower area relates to the local altitude with position about the longitudinal axis of the electrode array for example, as described above. And in this regard, with respect to the cross-section of figure 13, even though surface 840 is flat, the barrier is above that surface 840 with respect to local location about the longitudinal axis, even though with respect to the purely Cartesian coordinate system of the view of figure 13, surface 840 does not extend below any portion of the barrier, and in terms of the concept of the design barrier, with respect to location in the Y axis, the barrier is actually below surface 840.
[00126] Another way of explaining how the outer boundary of the carrier member is laid out with respect to the establishment of the protrusions can be seen utilizing polar coordinates. In this regard, pull accordance are transposed onto the cross-sections of the electrode array that are normal to the longitudinal axis. Figure 13 presents such a cross-section over which the polar coordinates are presented. Here, the zero angle is located at the 6 o’clock position, or otherwise with respect to the Y axis and the negative direction. Reference letter r is the distance from the longitudinal axis or otherwise the axis of symmetry or otherwise the geometric center of the carrier member with respect to the cross-section at issue to the outer profile of the carrier member. Theta is the angle that the vector presenting the value r is from the Y axis starting at the bottom. Note that the 0° angle is where the electrodes are located or otherwise where the center of the electrodes are located in at least some exemplary embodiments. In this regard, the value of r steadily increases with an increase in the angle Theta, which increases linear. The angle then increases at a lower rate or stops increasing or potentially even decreases when the vector reaches the curved portion and the third quadrant. The value of r begins to decrease at the linear portion in the third quadrant but then begins to increase in a nonlinear manner at about the beginning of the fourth quadrant with increasing Theta. In this regard, this is the beginning of the protrusion 825. The value of r then begins to decrease at about 110 or 105 degrees or so, and the decrease is nonlinear and increases with respect to the rate of decrease. The decrease then begins to be linear when it reaches the surface 840, although in an alternate embodiment, the value of r could be constant for the surface 840, such as where the surface 840 is curved and otherwise follows an arcuate profile. Of course, the value of r increases when the riser 8499 and/or the segmented protrusion 850 is reached but the value of r would continually decrease if the surface 840 was flat from portion 825 to portion 820 until reaching angle 180°, and then would increase again. The pattern would be reversed upon reaching the portion 820.
[00127] In an embodiment, the value of r between angles 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 125, 130, 135, 140, or 145, or any value or range of values therebetween in 1° increments is a value that is greater than or at least equal to a value that is 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25, or any value or range of values therebetween in 0.1 increments percent greater than the values of r immediately before and/or immediately after those values. In an exemplary embodiment, the value of r for any one or more of those angles can equal any one or more of those values with relation to a value of r at any of the angles 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, or 60 degrees, or any value or range of values therebetween in 1° increments. These properties are symmetric about the Y axis, or alternatively, if Theta is measured in the counterclockwise direction again starting at the bottom of the Y axis, those values are present, because in an exemplary embodiment, the carrier member and the electrode array, at least with respect to the outer profiles, are symmetric about the Y axis.
[00128] Note that the polar coordinate system can be applied to the cross-sections that pass through the lateral protrusion portions 830 and 860. For example, with respect to figure 17, the value of r decreases between transition points T2 and T3 with increasing angle Theta, but at transition point T3, even though the value of r should continue to decrease with increasing Theta, the value of r could become constant or increase with increasing Theta, or at least the rate of change of the value of r would be different than that which was the case prior to T3. Moreover, after 90°, when the value of r would begin to increase with respect to a linear sidewall that was parallel to the Y axis, the rate of increase would be greater and the overall value of the increase would be greater than that which would otherwise be the case with respect to the vertical sidewall. And then at transition point T4, the value of r or at least the rate of change of the value would begin to decrease again. As seen, owing to the parabolic nature of the outer surface of the carrier member in the fourth quadrant, the value of r will change in a manner that is not constant with increasing Theta.
[00129] And note that while the embodiments shown have lateral portions that are essentially perfectly normal to the longitudinal axis with respect to the direction of extension, in other embodiments, the directions of extensions of the lateral portions could include a longitudinally extending vector in addition to the lateral extending vector. By way of example only and not by way of limitation, the ends of the longitudinal portions could be “capped” by very shallow sideways “V”s (when viewed from the top). Or “U” shaped ends could be used. That said, non-shallow “V”s could be used where the vector in the longitudinal direction is greater than the vector of the lateral direction. In this regard, there would be no lateral portions 830 and 860, but instead, different longitudinal portions. In this regard, the concepts of lateral portions and longitudinal portions are dictated by the greatest vector associated with the extension thereof. And in a similar vein, the longitudinal portions need not extend perfectly longitudinally, as there can be a lateral vector associated with the extension. Indeed, in an embodiment, there is no lateral extending portion. By way of example only and not by way of limitation, an elongate diamond shape can be the form of the protrusion arrangement. In such an embodiment, there is no portion that extends in a purely longitudinal direction but if the diamond is long enough, and narrow enough, there will be no lateral portion by the definitions detailed above.
[00130] Embodiments include methods. FIG. 28 presents an exemplary flowchart for an exemplary method, method 2800. This includes method action 2810, which includes obtaining a cochlear implant electrode array. This can include obtaining the electrode array according to any of the versions detailed above, with or without the protrusions. In an exemplary embodiment, method action 2810 can be executed by removing the cochlear implant electrode array from a mould after moulding the silicone carrier member so that it carries the electrodes, etc. In another exemplary embodiment, this can be executed by obtaining a package electrode array hours or days or weeks or months after the electrode array is manufactured or otherwise is removed from a mould. In an embodiment, method action 2810 is executed by opening up a container in which the electrode array is contained for storage or for transportation from a location where the electrode array was manufactured to the location where method action 2800 is being executed. In an embodiment, method action 2810 is executed by receiving an electrode array laying on a tray. In an embodiment, method action 2810 is executed by receiving a hermetically packaged electrode array. In an exemplary embodiment, method action 2810 is executed by receiving a sterile cochlear implant electrode array.
[00131] Method action 2820 includes the action of placing the electrode array in a mould cavity. In an exemplary embodiment, this mould cavity is different than that which was described above with respect to the action 2810. By way of example only and not by way of limitation, this mould cavity is seen in figures 29-31. Figure 29 represents a cross-sectional view of a portion of a bottom piece 2915 of the mould 2910, in which is located an electrode array 846 as shown, although in an embodiment, it can be the electrode array 146 as detailed above, with respect to a mould that is modified from that under discussion, as will be detailed below. In this embodiment, there is another mould piece that is a mirror image of piece 2915 that goes over top of piece 2915 to seal the mould cavity and the other portions of the mould (more on this below) so that when the overmould material is injected via injection port 2920, the overmould material will be contained in the cavity of the mould, although excess overmould material will be permitted to exit the vents 2930 and 2932. More specifically, method action 2820, includes placing the electrode array 846 into the mould subcavity 2950 of piece 2915, and then closing the mould subcavity 2950 with the opposite piece, thus trapping the electrode array 846 in the mould cavity formed by subcavity 2950 and the subcavity of the opposite piece.
[00132] While the embodiment depicted in figure 29 shows the electrode array 846 and a straighten orientation, in an embodiment, the mould cavity can be such that the electrode array has a curved orientation, whether that curved orientation is the relaxed orientation, or substantially relaxed orientation, or whether that curved orientation is an orientation that is in between its relaxed orientation and the fully straighten orientation. In an exemplary embodiment, the curvature of the electrode array with respect to its relaxed position is reduced (actually, expanded with respect to local radii of curvature) by less than, equal to, or greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500, or 3000%, or any value or range of values therebetween in 1% increments or more. Indeed, with respect to straightening the electrode array from its current position, the radius of curvature is increased by an effectively infinite amount and thus greater than 3000%.
[00133] While the embodiment of the mould 2910 is shown as having two components or otherwise two mould pieces, embodiments can include a mould that has three or more components. Note also that the components may not necessarily be mirror images of each other. In an embodiment, mould piece 2915 could actually have a “larger” sub cavity portion than the opposite mould piece. This can be utilitarian with respect to securing the electrode array into that mould sub cavity 2950. For example, if the mould sub cavity 2950 extended about more than 180° of the electrode array, the portions of the mould sub cavity 2915 that extend beyond 180 degrees would work to secure or otherwise hold the electrode array in the mould subcavity until the opposite piece is placed over the mould subcavity to create the entire cavity. Because of the flexible nature of the silicone or other flexible resilient material of the carrier member, the electrode array can easily be removed from the after the opposite piece is taken away from piece 2915 (and of course, can easily be placed into the mould subcavity 2915 because of the resilient and flexible nature of the silicone).
[00134] Returning back to method 2800, as noted above, method 2800 further includes method action 2830, which includes the action of overmoulding a substance onto a portion of the array that was placed into the cavity in method action 2820 to form a modified cochlear implant electrode array, the mould cavity forming an exterior surface of the substance (forming in the sense that the mould “forms” the surface, and the surface would have another form if the mould cavity was different). In an exemplary embodiment, the overmoulded substance forms an overmould on the electrode array. In an exemplary embodiment, the overmould is located on the dorsal portion of the electrode array. In an exemplary embodiment, the overmould is located within the boundaries of the protrusion arrangement 810 above. In an exemplary embodiment, the overmould is not located within any protrusion arrangement. Indeed, in an embodiment, there is no protrusion arrangement of the electrode array.
[00135] In an exemplary embodiment, the overmould on the electrode array establishes a stiffer portion of the electrode array relative to the carrier member so as to establish a resistance to Euler buckling during insertion. In an embodiment, the overmould is an additive to the functionality of the electrode array, and otherwise has utilitarian value in addition to the general utilitarian value of the electrode array without the overmould. [00136] It is to be understood that by the phrase “overmould” it is meant a structure or a body that is distinctly separate from the carrier member of the electrode array. In this regard, it is not monolithic with the carrier member. Note that in an embodiment, the overmould can be the exact same material as the carrier member. However, the distinctness between the overmould and the carrier member can be ascertained.
[00137] As noted above, method 2800 results in the formation of a modified cochlear implant electrode array. In this regard, the electrode array that is placed into the mould cavity in method action 2820 is an electrode array that is a functional electrode array and otherwise is, for all intents and purposes, ready for use with respect to its intended purpose. By way of example only and not by way of limitation, if the electrode array is an implantable electrode array, the electrode array is ready for implantation (providing that it is sterilized or any other of the finalization actions are executed). In this regard, the overmould is an additional feature of the array and otherwise enhances the utilitarian value of the electrode array, or otherwise provides additional utilitarian value of the electrode array. By rough analogy, obtaining a vehicle and then placing a turbo on to the vehicle enhances the utilitarian value of the vehicle. The obtained vehicle is still a fully functional vehicle. Perhaps by another analogy, obtaining a vehicle and then waxing the vehicle provides a layer of protection on the vehicle paint which was not present prior to the waxing.
[00138] The overmould can be seen in figures 12 and 13 and 16 and 18 for example, as overmould 890. Figure 32 shows the modified electrode array 8461 that results from method 2800. In an exemplary embodiment, the outer boundaries of the overmould are established by the protrusion arrangement 810. In an exemplary embodiment, the mould cavity compresses the protrusion arrangement 810 when the pieces of the mould are placed together, and the mould pieces are tightened against one another. In this regard, the mould cavity has interior dimensions that are different, and at some locations, smaller, then the exterior dimensions of the electrode array placed in the mould cavity. More particularly, when the protrusion portions of the protrusion arrangement are compressed and otherwise deformed by the mould cavity, the resilient and flexible nature of the protrusions “push back” against the interior of the mould cavity and thus create a seal or otherwise a barrier between one side of the protrusion portion and the other side of the protrusion portion. In particular, with respect to figure 29, a barrier seal between the top portion of the carrier and the bottom portion of the carrier, the bottom portion being where the electrodes are located. Accordingly, when the overmould material is injected into the mould cavity via channel 2920, the overmould material will flow into the space 2929 between the electrode carrier 849, and the mould surface 2950, which space is bounded by the protrusion arrangement and then the surface 840 therein, where the combination of such forms a basin, and then the surface 2950, which surface arcs around the top of the electrode array 846 about the longitudinal axis of the electrode array. Thus, the overmould material will fill or at least partially fill that space, and will not flow past the protrusion arrangement 810, because the surface 2950 compresses the protrusion arrangement a sufficient amount to create a seal between the carrier member and the interior surface of the mould cavity.
[00139] Note that the vents 2932 act to relieve or otherwise mitigate a pressure increase inside the aforementioned space inside the protrusion arrangement 810. In this regard, excess overmould material will flow out of the vents 2932 and 2930 which are located at the distal and lateral ends of the protrusion arrangement. In an embodiment, when the now modified electrode array is removed from the mould, any excess overmould material that has flowed into the vents can be removed such as by cutting or clipping.
[00140] Accordingly, the protrusion arrangement forms a barrier that prevents movement of the overmould material during the moulding process from one side of the protrusion arrangement to the other side of the protrusion arrangement. This can have utilitarian value with respect to establishing and overmould body that has dimensions that fall within a desired tolerance relative to that which would otherwise be the case. And note that in this exemplary embodiment, this can be an automated process with respect to the amount of overmould material that is flowed into the mould cavity. In an exemplary embodiment, upon a pressure or a certain volume being reached (volume of overmould material flowing into the cavity), continued flow is halted. That said, in some embodiments, no control monitoring is applied. Instead, the vents are relied upon to alleviate any pressure arrangement. Indeed, in an exemplary embodiment, it is the structure of the electrode array and the mould cavity that establishes the amounts of overmould material that is located on the electrode array, with the exception of the amounts that flow into the vents. This is opposed to, for example, depositing the overmould material on to the top of the array by hand or otherwise doing so without the mould surface 2590 present. Accordingly, in an exemplary embodiment, a surface of the overmould body 890 is formed or otherwise established by a mould surface, such as surface 2950. In an exemplary embodiment, at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, or 75%, or any value or range of values therebetween in 1% increments of the outer surface overmould body, if the overmould body was stripped off the remainder of the electrode array, is formed or otherwise established by the mould cavity surface.
[00141] Accordingly, in an exemplary embodiment, with respect to method 2800, during the action of overmoulding with respect to method action 2830, the substance that is overmoulded onto the carrier member is halted from traveling past a discrete location on the cochlear implant electrode array so that there is another portion of the array without the substance. In this exemplary embodiment, this is executed utilizing the protrusions on the carrier member. But that said, in an alternate embodiment, it is the mould that includes protrusions that deform the carrier member so as to prevent the movement of the substance. Thus, an embodiment includes a method where the mould cavity includes a structure that compresses the electrode array over a defined discrete area that encloses another area during the overmoulding, the compression being more than areas adjacent the discrete area and the “another area” is where the substance is overmoulded.
[00142] Figure 33 shows a cross-section of an exemplary mould that includes two pieces 3216 and 3215, which pieces are analogous to the pieces noted above with respect to mould 2910. Here, this view is shown with respect to a direction looking down the longitudinal axis of the electrode array, with the electrode array in the mould cavity when the mould is fully closed. Here, mould piece 3215 includes protrusion 3215 A and mould piece 3216 includes protrusion 3216A. In this exemplary embodiment, there protrusions of the mould pieces compress and otherwise deform the body of the carrier member 849 as shown, where in its relaxed on deform state, the sidewalls of the carrier member 849 at the locations where the protrusions are now located are linear and vertical (as represented by the vertical phantom line on the left side of the carrier). In this exemplary embodiment, there are no protrusions or sealing arrangements located on the electrode array prior to insertion into the mould. Instead, the deformation of the carrier member by the protrusions of the mould cavity, where the resilient nature of the carrier member pushes back against the deformation, establishes a seal that prevents the overmould material 890 from flowing beyond a certain point around the carrier member.
[00143] It is noted that embodiments can include a combination of the protrusions on the carrier member and the protrusions on the mould cavity surface. In an exemplary embodiment, the crest of the protrusion of the mould cavity can coincide with the crest of the protrusion of the carrier member so that maximum deformation is achieved when the mould pieces are closed together so as to establish the aforementioned barrier or otherwise seal. [00144] In view of the above, in an exemplary embodiment, the mould cavity includes a structure that deforms the electrode array over a defined discrete area to form a barrier that halts the substance from traveling past the discrete location.
[00145] Corollary to this is that in an embodiment, exemplary thereof, the electrode array includes a structure that is compressed over a defined discrete area that encloses another area during the overmoulding, the compression being more than that at areas adjacent the discrete area (e.g., inside or outside the border formed by the protrusion on the mould, or the protrusion on the array). In an embodiment, the compression, as measured by strain, is equal to or greater than 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1500, 2000, 2500 or 3000, 4000, 5000, 6000, 7000% or any value or range of values therebetween in 1% increments or more than that at another location that is 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.1, 0.125, 0.15, 0.175, 0.2, 0.225, 0.25, 0.275, 0.3, 0.35, 0.4, 0.45, or 0.5 mm away or any value or range of values therebetween in 0.01 mm increments from the compression (surface distance, as opposed to linear distance (New York to Sydney is 12,000 miles, not the 8,000 miles through the center of the Earth)), or at the adjacent area, or within the bounded area. The value could be infinite if there is zero compression at the another area / location. In an embodiment, the “another area” is where the substance is overmoulded. In an embodiment, the aforementioned difference exists over at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of where the substance is overmoulded (that is, directly in contact with the carrier member), with respect to an average (mean, median and/or mode) of the compression (the larger compression) and/or a maximum compression. In an embodiment, this can be estimated based on the mould features and/or the electrode array features (including the makeup of the protrusion on the array).
[00146] In an embodiment, the electrode array includes a structure that deforms when in the mould cavity over, the deformation forming a barrier that halts the substance from traveling past the deformed structure. The deformation can be gauged according to any of those examples detailed above.
[00147] In an embodiment, the barrier that is formed on the electrode array is a means for sealing for an overmoulding process. In an exemplary embodiment, the protrusion is a sealing bump. [00148] In an exemplary embodiment, the outer boundary of the overmoulding material is bounded by the protrusion arrangement when viewed from the top of the electrode array. In an exemplary embodiment, the lateral outer boundary of the overmoulding material is bounded by the protrusion arrangement.
[00149] In an exemplary embodiment, where there is the protrusion on the outside of the carrier member, the protrusion extends around the overmoulding body that is attached to the outside of the carrier member.
[00150] An embodiment can include a cavity of the overmould mold that is flush with what would be the surface of the electrode array without the protrusions, which enables the sealing because the protrusions are compressed / the carrier is compressed to what the carrier would have been, or at least about what the carrier would have been, without the protrusions.
[00151] In an embodiment, a pressure within the mould during the injection process can be 100, 150, 200, 250, 300, 350, 400, 500, 600, 700, 800, 900, 1000, 1250, 1500, 1750, 2000, 2250, 2500, 2750 or 3000 KPa or any value or range of values therebetween in 10 KPa increments.
[00152] Figure 19 presents a variation of the teachings detailed herein. In this embodiment, the shape of the carrier member has portions 825X and 820X that have at least some of the features of the transition points detailed herein, but where the feature here is that after reaching a high point with respect to direction and the Y axis, the outer profile of the carrier member decreases in altitude with location closer to the Y axis. In this exemplary embodiment, when the electrode arrays placed into the overmould mould, the closure of the mould pushes the portions 825X and 820X inward and upward, which compresses the carrier member, and thus creates a seal between the mould cavity and the portions of the carrier member that are “below” the compressed portions.
[00153] Briefly, as seen from the embodiments of FIGs. 9-19, the barrier does not extend about one or a plurality of electrode contacts. That is, the barrier extends about an area that does not encompass the electrodes. Indeed, in an exemplary embodiment, the barrier is located entirely in a “hemisphere” opposite the electrodes, or at least the center of the electrodes. That said, figure 19A shows an example of a barrier that does extend about the electrodes 148 (there would be lateral portions at the proximal and distal ends of the enclosed area. [00154] As noted above, in some embodiments, there are one or more raised segmented portions 850 inside the boundary established by the protrusion arrangement. In an exemplary embodiment, the raised segmented portions 850 provide additional adherence of the overmoulded body to the carrier member. In an exemplary embodiment, the raised segmented portions 850 are sized and dimensioned to results in a desired volume of overmoulding material resulting from the overmoulding process. In this regard, the raised segmented portions 850 extend into the cavity that is established between the electrode array and the remainder of the surface of the mould that is not in contact with the electrode array. This is the cavity into which the overmoulding material flows into during the overmoulding process. By varying the dimensions of the segmented portions 850, the resulting volume of the overmoulding body can be varied. Thus, embodiments include designing and manufacturing protrusions of a given design and/or given dimensions so as to achieve a desired volume of overmoulded material. In an embodiment, the protrusions can be formed on the electrode array, and then one or more can be removed prior to the overmoulding process/prior to being placed into the mould for the overmoulding process, so as to increase the resulting volume of the overmoulded body. In an exemplary embodiment, the segmented protrusions are designed and configured to be accurately removed from the electrode array. In an exemplary embodiment, a surgical scalpel can be used to slice off one or more protrusions. In an embodiment, the protrusions can be segmented or otherwise can include a weakened area to facilitate the removal thereof. The segmented protrusions can also provide utilitarian value with respect to providing additional surface for the overmould body to “grip” to the array, and provide more localized gripping, which can be utilitarian because of the fact that the overall array will curl, and thus a pure locally planar face adherence might be more likely to fail / come apart when the array is curled.
[00155] In an embodiment, the segmented portions 850 are segmented protrusions, as detailed above. In this exemplary embodiment, the segmented protrusions 850 are not sealing protrusions, and otherwise do not prevent the flow of the overmoulded material from reaching an opposite side of the carrier member. Note also that this is the case with respect to the riser 8499. The riser does not prevent the overmoulded material from flowing from one side of the carrier to the opposite side of the carrier. In this case, the riser portion is not a sealing portion.
[00156] As seen, in an exemplary embodiment, the segmented portions 850 are sized and dimensioned so as to contact surface 2950 of the mould cavity. That said, some protrusions are sized and dimensioned so as to not touch the surface 2950 the mould cavity. Accordingly, the overmoulded material will flow over the tops of some of the protrusions and not others during the moulding process. This can be seen in the top view of the modified electrode array 8461 in figure 31, where segmented protrusions 850A extend through the top of the overmoulded material 890 and thus form islands in the overmoulded material, whereas others 850B remain beneath the outer surface of the overmoulded material 890.
[00157] In an embodiment, there are 10 protrusions inside the protrusion arrangement 810. Six of these extend through the top of the overmoulded material 890. In other embodiments, more or less protrusions are present and/or more or less protrusions extend through the top of the overmould 890. In an embodiment, there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 35, 40, 45, or 50, or any value or range of values therebetween in 1 increment protrusions inside the protrusion arrangement and/or in contact with the overmould body 890, not including the protrusion(s) that make up the boundary. And while the embodiment shown depicts the protrusions arrayed in a linear serial fashion, in other embodiments, the protrusions can be arrayed in a nonlinear manner and/or a non-serial manner. In an embodiment, the protrusions can be arrayed in parallel in 2 columns were even 3 columns depending on how much room there is inside the protrusion arrangement, and the protrusions can be aligned with each other or otherwise abreast with each other, or the protrusions can be in lockstep one after the other.
[00158] While the embodiments depicted protrusions as elongate rakes track tape shapes, other embodiments can include protrusions of different shapes. By way of example, figure 25 shows various shapes of segmented protrusions 850 when viewed from the top.
[00159] In an exemplary embodiment, the material of the overmould body 890 is a flexible material. In an exemplary embodiment, the overmould body 890 is made of silicone, such as biocompatible silicone. In an exemplary embodiment, the overmoulded body is made of the same silicone as the carrier member. In an exemplary embodiment, the overmould body is made of the same class of silicone as the carrier member. An exemplary embodiment, the overmould material has flexibility that is less than and/or greater than and/or equal to that of the carrier member. In an exemplary embodiment, the overmould material has a flexibility and/or density within 5, 10, 15, 20, 25, or 30% or any value or range of values therebetween in 1% increments or more of the flexibility of the material of the carrier member. In some exemplary embodiments, the overmould material is a combination of silicone and a therapeutic substance. It can be a mixture of such when the material is injected into the mould cavity, where in an exemplary embodiment, a dispersion of the therapeutic substance in the silicone is uniform or substantially uniform, and thus when the silicone sets or otherwise cures, the dispersion of the therapeutic substance within the cure silicone is also uniform. In an exemplary embodiment, the therapeutic substance elutes and/or diffuses out of the silicone and into the body of the recipient, such as when the array is an implantable array. The overmould material of the overmould body 890 can be any therapeutic substance delivery silicone based materials currently available, such as those that are utilized with cochlear implant electrode arrays. In an embodiment, the material is a . l%-50% w/w therapeutic substance (e.g., drug) loaded silicone. In an embodiment, the therapeutic substances could be Dexamethasone, base, acetate, sodium phosphate, Prednisone, Fluticasone, Other cortico steroids, BDNF/NT3 Gene therapy (or other biologies). The silicone could be a biocompatible silicone excipient with a durometer of 5-80 shore A, Nusil, DDU-4320, DDU-4870, Elkem D125, D140, etc. Any material that can enable the delivery of a therapeutic substance within a body, such as within a cochlea, such as within the scala tympani, after implantation, that can have therapeutic value and can be injection moulded in accordance with the teachings above or variations thereof to establish the overmould body 890 can be utilized in at least some exemplary embodiments. In an embodiment, the overmoulded body provides utilitarian value with respect to delivering a drug or other therapeutic substance to a human internally, such as in the cochlea. In this regard, embodiments are directed towards a therapeutic substance delivery system. Therapeutic substances include drugs, but also include nondrug substances. In an exemplary embodiment, therapeutic substances include steroids and biologies. Therapeutic substances can also include minerals and the like. In an embodiment, an anti-inflammatory drug, such as Dexamethasone is mixed into an uncured silicone, which mixture is injected into the overmoulding mold, and overmoulded over the carrier member, and when cured, forms the modified electrode array. Thus, embodiments include a therapeutic substance that is a drug that is mixed in a silicone separate from the electrode array carrier.
[00160] In an exemplary embodiment, the devices can be devoid of glue holding the therapeutic substance and/or the therapeutic substance is a drug that is mixed in a silicone separate from the electrode array carrier.
[00161] In some embodiments, the overmoulded body dissolves in part to transfer the therapeutic substance into the cochlea / the perilymph of the cochlea. In an exemplary embodiment, the therapeutic substance or drug can elute from the overmoulded body. [00162] With respect to distance, the overmolded body can extend a distance that is equal to less than, or greater than 150, 140, 130, 120, 110, 90, 80, 70, 60, 50, 40, 30, 20 or 10% or any value or range of values therebetween in 1% increments of DI.
[00163] In view of the above, in an exemplary embodiment, there is an assembly as detailed above, where the protrusion on the outside of the carrier member extends around a therapeutic substance attached to the outside of the carrier member. The therapeutic substance can be entrained or otherwise dispersed in a silicone material. Thus, in an exemplary embodiment, there is an assembly or an apparatus as detailed above, where the protrusion on the outside of the carrier member extends around a body containing a therapeutic substance attached to the outside of the carrier member. In an exemplary embodiment, there is an assembly as detailed above, including a body including a therapeutic substance, the body overmoulded on to the outside of the carrier member. In this exemplary embodiment, a boundary of the body is established by material of the electrode carrier member being deformed during the overmoulding of the body onto the outside of the carrier member. In an exemplary embodiment, this deformation is not present when the electrode carrier member is in a relaxed state. In an exemplary embodiment, this can correspond to the protrusions that are on the carrier member. In an exemplary embodiment, this can correspond to the deformation of the carrier member imparted by the protrusions in the mould cavity.
[00164] Note that in some exemplary embodiments, when the carrier member and/or the protrusions of the electrode array return from their deformed state, which deformation is a result of the electrode array being located in the mould for the overmoulding process, the portions of the carrier member and/or the protrusions of the electrode array will drag, pull, and/or push the overmoulded body that are in contact therewith from the position that the body would be in in the absence of the return from the deformed state. This will occur after the silicone has cured in the mould. Thus there will be stress risers and deformation of the body 890 relative to that which would otherwise be the case. Accordingly, at least some exemplary embodiments results in an electrode array that can be evaluated to determine that the carrier member was deformed during the process of overmoulding. The stresses and strains of the body, and also in some instances, of the carrier member, in the final product will be indicative of the manufacturing process just detailed. In an exemplary embodiment, there is an assembly as detailed above, where a stress riser exists at a majority of the lateral boundary (the sides and ends) of the body overmoulded on to the outside of the carrier member owing to the elastic memory of the electrode carrier member. In an exemplary embodiment, the stress riser exists at at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of the lateral boundary of the body.
[00165] Embodiments thus include an assembly where the protrusion forms a closed reservoir for the therapeutic substance when the therapeutic substance is overmoulded on to the carrier member. And consistent with the teachings detailed above with respect to the protrusions inside the protrusion arrangement, in some exemplary embodiments, there are a plurality of raised areas extending above the body of which the therapeutic substance is entrained or otherwise embedded.
[00166] In returning back to method 2800, in an exemplary embodiment, the substance that is overmoulded in method action 2830 is a substance that includes a therapeutic substance. In an exemplary embodiment, the teachings detailed herein can enable a more precise amount of therapeutic substance to be attached to the stimulating assembly relative to that which would otherwise be the case. More specifically, in an exemplary embodiment, the amount of therapeutic substance can be controlled within tighter tolerances relative to that which would otherwise be the case. Thus, in an exemplary embodiment, there is a method that includes identifying, before the action of overmoulding, an amount of the therapeutic substance to be overmoulded onto the array to form the modified cochlear implant electrode array. In this exemplary embodiment, upon completion of the overmoulding action, in an amount of therapeutic substance overmoulded onto the modified cochlear implant electrode array is within plus or minus35, 30, 25, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, 4, 3 or 2% or any value or range of values therebetween in 0.1% increments of the identified amount. This can have utilitarian value with respect to providing an electrode array that has a specific amount of therapeutic substance thereon, so that the release rates and/or the release amount can be better determine or otherwise better controlled. In this regard, the “dosage” of the therapeutic substance is desired to be controlled within a tighter manner than that which would otherwise be the case without the teachings detailed herein. For example, the tolerancing of the mould cavity and the precision process of injection moulding the therapeutic substance containing material can provide for the heightened tolerances relative to a non-automated or non-mechanical process, such as depositing the therapeutic substance by hand, utilizing a hand syringe or the like. And corollary to this, in an exemplary embodiment, there is a method that includes repeating the actions of obtaining, placing overmoulding and identifying and/or any other method actions detailed herein at least 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39 or 40 or any value or range of values therebetween in one increment times within a period of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 48, 72, 100, 125, 150, 175, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 750, 800, 900 or 1000 hour period or any value or range of values therebetween in 1 hour increments or within 1, 2, 3, 4, 5, 6, 7, 8 or 9 days or a half a month or a month.
[00167] In an embodiment, the teachings herein can provide improvements to develop a more automated process for the manufacturing of the drug eluting electrode arrays for more ease of manufacture and/or to produce more consistent parts to meet the exacting drug release specifications imposed by regulators, such as the aforementioned tolerances. In an embodiment, the drug-eluting material is thus attached to the electrode array by a non-manual procedure. In this regard, it is noted that the basin established by the protrusions is not a well as that phrase is understood in the art with respect to a cavity or void in which to manufacture a drug-eluting cochlear implant electrode array. In some exemplary embodiments, the teachings herein explicitly exclude the concept of utilizing a so-called 2K moulding approach. In an exemplary embodiment, the material containing the therapeutic substance overmoulded on to the carrier member is not so overmoulded without first removing the carrier member from the mould that was utilized to produce the carrier member. Put another way, the mould in which the overmoulding takes place is not the same that was utilized to make the carrier member in the first instance. That is, embodiments include utilizing two separate moulds having different mould cavity configurations, a first to establish the cochlear implant electrode array in general, and the carrier member thereof specifically, and a second to overmoulded the therapeutic substance containing material on to the carrier member. The first mould will have the contours of the resulting carrier member, with or without the protrusions, in its relaxed state. The first mould will not have a gap or cavity for the therapeutic substance to be injected subsequent to the curing of the carrier member.
[00168] As seen above, in some embodiments, the therapeutic substance containing material is located only on one side of the carrier member. In an exemplary embodiment, with respect to a cross-section normal to the longitudinal axis, the therapeutic substance containing material and/or the outermost portions of the barrier / protrusion arrangement subtends an angle no more than 145, 140, 135, 130, 125, 120, 115, 110, 105, 100, 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30 or 25 degrees or any value or range of values therebetween in 1 degree increments (of course, the values would be different for the two, as the body will be less than the outer periphery of the barrier). In an embodiment, this is the average over the length of the material (mean, median and/or mode).
[00169] The utilitarian value with respect to injection moulding the drug loaded silicone directly onto the carrier member can enable the aforementioned utilitarian features in at least some exemplary embodiments. The teachings detailed herein can prevent the material containing the therapeutic substance from leaking or flashing to other parts the electrode array where such is not desired, such as for example, to the electrode contacts, where the flashing of the therapeutic substance containing material over the electrodes could reduce the efficacy of the electrodes after implantation into a human. Further, the flashing results in a less tolerance amount of therapeutic substance delivery material provided on a given electrode array. The teachings detailed herein can enable better control of the placements, or more accurately, the resulting locationality of the resulting overmoulded body relative to that which would otherwise be the case with respect to, for example, manual depositing the therapeutic substance containing material onto the electrode array. In a sense, the teachings detailed above rely on structure that mimics the function of an O-ring, whether that be the protrusions that are formed on the carrier member, or whether that be the protrusions inside the mould that the form the normally shaped carrier member, or a combination of the two. The idea is that the O-ring concept can be used to shut off against gas, water, etc., owing to overpressure on one side of the ring relative to the other side of the ring.
[00170] Any arrangement disclosed herein can be an arrangement that is refillable and/or rechargeable, unless otherwise specified. And again, other embodiments include implantable portions that cannot be re-filled or recharged, at least after implantation.
[00171] It is noted that any disclosure with respect to one or more embodiments detailed herein can be practiced in combination with any other disclosure with respect to one or more other embodiments detailed herein. That is, some exemplary embodiments include any one or more of the teachings detailed herein combined with any one or more of the other teachings detailed herein, unless otherwise stated such, providing that the art enables such. It is also noted that any disclosure herein of any feature corresponds to a disclosure of an exemplary embodiment that explicitly excludes that given feature from utilization with any one or more other features detailed herein unless otherwise specified providing that the art enables such. [00172] It is noted that any disclosure herein of any method action corresponds to a disclosure of a device and/or system that enables that method action. It is noted that any disclosure herein of any method of manufacturing or otherwise developing or making a device disclosed herein corresponds to a disclosure of the resulting device that results from that method. It is noted that any disclosure herein of any apparatus and/or system corresponds to a disclosure of providing and/or making that apparatus and/or system. It is noted that any disclosure herein of any functionality corresponds to a device and/or system is configured to provide that functionality. It is noted that any disclosure of any device and/or system herein corresponds to a disclosure of a method of utilizing that device and/or system.
[00173] In this regard, it is noted that any disclosure of a device and/or system herein also corresponds to a disclosure of utilizing the device and/or system detailed herein, at least in a manner to exploit the functionality thereof. Further, it is noted that any disclosure of a method of manufacturing corresponds to a disclosure of a device and/or system resulting from that method of manufacturing. It is also noted that any disclosure of a device and/or system herein corresponds to a disclosure of manufacturing that device and/or system.
[00174] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. It will be apparent to persons skilled in the relevant art that various changes in form and detail can be made therein without departing from the spirit and scope of the invention. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.

Claims

CLAIMS What is claimed is:
1. An assembly, comprising: a plurality of electrode contacts; an electrode carrier member; and a protrusion extending about at least two of the plurality of electrode contacts on an outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
2. The assembly of claim 1, wherein: the assembly is a cochlear implant electrode array.
3. The assembly of claims 1 or 2, wherein: the protrusion is a monolithic part of the electrode carrier member.
4. The assembly of claims 1, 2 or 3, wherein: the plurality of electrodes includes at least three electrodes; and with respect to location along the vector, the protrusion extends past the at least three electrodes.
5. The assembly of claims 1, 2, 3 or 4, wherein: the assembly includes a body overmoulded onto the carrier member, the body being inside a perimeter of the protrusion.
6. The assembly of claims 1, 2, 3, 4 or 5, wherein: the electrode carrier member is an elongate carrier member; and the protrusion is an endless protrusion.
7. The assembly of claim 1, wherein: the protrusion is made out of silicone.
8. The assembly of claims 1, 2, 3, 4, 5 or 6, wherein: the protrusion bounds and surrounds a lower area relative to the barrier.
9. The assembly of claims 1, 2, 3, 4, 5, 6 or 7, further comprising: a receiver-stimulator of a cochlear implant.
10. The assembly of claims 1, 2, 3, 4, 5, 6, 7, 8 or 9, wherein: the electrode carrier member is made out of silicone.
11. An apparatus, comprising: a plurality of electrodes; an electrode carrier member; and a raised area on an outside of the carrier member, wherein the apparatus is a cochlear implant electrode array, the plurality of electrodes are arrayed in a longitudinal direction of the cochlear implant electrode array, and the raised area extends in the longitudinal direction contiguous with at least two electrodes.
12. The apparatus of claim 11, wherein: the plurality of electrodes includes at least 14 electrodes arrayed along the longitudinal direction; and with respect to location along the longitudinal direction, the barrier extends past the at least 14 electrodes.
13. The apparatus of claims 11 or 12, wherein: the raised area and a portion of the carrier member proximate the raised area form an elongate basin on the outside of the electrode carrier member.
14. The apparatus of claims 11, 12 or 13, wherein: the raised area includes a first section and a second section spaced away from the first section, both the first section and the second section extending in the longitudinal direction; and the apparatus includes a section lower than the raised area between the first section and the second section.
15. The apparatus of claim 14, wherein: the raised area includes a third section and a fourth section spaced away from the third section, the third section linking the first and second sections at a first location and the fourth section linking the first and second sections at a second location opposite the first location relative to the longitudinal direction; and the lower section is between the third section and the fourth section.
16. The apparatus of claim 14, wherein: a plurality of raised sections are located between the first and second sections, the raised sections being raised relative to the section lower than the raised area.
17. The apparatus of claims 11, 12, 13, 14, 15 or 16, wherein: the raised area is resiliently compressible.
18. The apparatus of claims 11, 12, 13, 14, 15, 16 or 17, wherein: the raised area forms a boundary of a material containing a therapeutic substance, the material overmoulded onto the electrode carrier member.
19. An assembly, comprising: an electrode contact; an electrode carrier member; and a protrusion on an outside of the carrier member forming at least a portion of an arrangement that bounds an area on an outer surface of the carrier member, wherein the assembly is an implantable stimulating assembly.
20. The assembly of claim 19, wherein: the protrusion is on an opposite side of the electrode carrier member from the electrode contact.
21. The assembly of claims 19 or 20, wherein: the protrusion on the outside of the carrier member extends to enclose an area on the carrier member.
22. The assembly of claims 19, 20 or 21, wherein: the protrusion is a sealing bump.
23. The assembly of claims 19, 20, 21 or 22, wherein: the assembly includes at least 7 electrodes arrayed along a length of the carrier member; and with respect to location along a longitudinal axis of the carrier member, the protrusion extends past the at least 7 electrodes.
24. The assembly of claim 19, wherein: the protrusion follows a path with at least two elongate portions.
25. The assembly of claims 19, 20, 21, 22, 23 or 24, wherein: the protrusion is configured to form a closed reservoir for a material when the material is overmoulded onto the carrier member.
26. The assembly of claims 19, 20, 21, 22, 23 or 24, wherein: the assembly includes a plurality of raised portions inside a boundary established by the protrusion.
27. The assembly of claim 26, wherein: the plurality of raised areas extend above a body overmoulded onto the carrier member.
28. The assembly of claim 27, wherein: the body is a material made up of at least silicone and a therapeutic substance dispersed in the silicone of the body.
29. The assembly of claim 19, wherein: a first cross-section of the electrode carrier member lying on a plane that is normal to a first axis of the electrode carrier member includes a first portion of a teardrop outer profile of the protrusion; and a second cross-section of the electrode carrier member lying on a plane that is normal to a second axis of the electrode carrier member that is normal to the first axis of the electrode carrier member includes a second partial teardrop outer profile of the protrusion and a third partial teardrop outer profile of the protrusion; and an outer profile of the second cross-section of the electrode carrier member is symmetrical about a plane lying on and parallel to the first axis.
30. An assembly, comprising: an electrode contact; an electrode carrier member; and a body including a therapeutic substance, the body overmoulded onto the outside of the carrier member, wherein the assembly is an implantable stimulating assembly, and a stress riser exists at a majority of the lateral boundary of the body owing to elastic memory of the electrode carrier member.
31. An assembly, comprising: a plurality of electrode contacts; and an electrode carrier member; and a barrier extending on an outside of the carrier member, wherein the barrier extends at least one of: on a side of the carrier member different than a side on which centers of the electrode contacts are located; or with the carrier member in a straightened orientation, a direction generally parallel to a vector extending through at least two of the electrode contacts of the plurality of electrodes and past the at least two electrodes, and the assembly is an implantable stimulating assembly.
32. The assembly of claim 31, wherein: the assembly is a cochlear implant electrode array.
33. The assembly of claims 31 or 32, wherein: the barrier is a monolithic part of the electrode carrier member.
34. The assembly of claims 31, 32 or 33, wherein: the plurality of electrodes includes at least three electrodes; and with respect to location along the vector, the barrier extends past the at least three electrodes.
35. The assembly of claims 31, 32, 33 or 34, wherein: the assembly includes a body overmoulded onto the carrier member, the body being inside a perimeter of the barrier.
36. The assembly of claims 31, 32, 33, 34 or 35, wherein: the electrode carrier member is an elongate carrier member; and the barrier is an endless barrier.
37. The assembly of claims 31, 32, 33, 34, 35 or 36, wherein: the barrier is a means for sealing for an overmoulding process.
38. The assembly of claims 31, 32, 33, 34, 35, 36, or 37, wherein: the barrier bounds and surrounds a lower area relative to the barrier.
39. The assembly of claims 31, 32, 33, 34, 35, 36, 37 or 38, wherein: the barrier bounds and surrounds a body overmoulded onto the carrier member.
40. The assembly of claims 31, 32, 33, 34, 35, 36, 37, 38 or 39, wherein: the body contains a therapeutic substance.
41. A method, compri sing : obtaining a cochlear implant electrode array; placing the electrode array in a mould cavity; and overmoulding a substance onto a portion of the array to form a modified cochlear implant electrode array, the mould cavity forming an exterior surface of the substance, wherein during the action of overmoulding, the substance is halted from traveling past a discrete location on the cochlear implant electrode array so that there is another portion of the array without the substance.
42. The method of claim 41, wherein: the substance includes a therapeutic substance.
43. The method of claims 41 or 42, wherein: the substance includes a therapeutic substance; the method includes identifying, before the action of overmoulding, an amount of the therapeutic substance to be overmoulded onto the array to form the modified cochlear implant electrode array; and upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 20% of the identified amount.
44. The method of claim 43, wherein: upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 10% of the identified amount.
45. The method of claim 43, wherein: upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 5% of the identified amount.
46. The method of claim 43, further comprising: repeating the actions of obtaining, placing, overmoulding and identifying at least 10 times within a 96 hour period.
47. The method of claims 41, 42, 43, 44, 45 or 46, wherein: the mould cavity includes a structure that compresses the electrode array over a defined discrete area that encloses another area during the overmoulding, the compression being more than areas adjacent the discrete area; and the another area is where the substance is overmoulded.
48. The method of claims 41, 42, 43, 44, 45, 46 or 47, wherein: the mould cavity includes a structure that deforms the electrode array over a defined discrete area to form a barrier that halts the substance from traveling past the discrete location.
49. The method of claims 41, 42, 43, 44, 45, 46, 47 or 48, wherein: the electrode array includes a structure that is compressed over a defined discrete area that encloses another area during the overmoulding, the compression being more than that at areas adjacent the discrete area; and the another area is where the substance is overmoulded.
50. The method of claims 41, 42, 43, 44, 45, 46, 47, 48 or 49, wherein: the electrode array includes a structure that deforms when in the mould cavity, the deformation forming a barrier that halts the substance from traveling past the deformed structure.
51. An assembly, comprising: an electrode contact; an electrode carrier member; and a body including a therapeutic substance, the body overmoulded onto the outside of the carrier member, wherein the assembly is an implantable stimulating assembly, and a boundary of the body is established by a material of the electrode carrier member being deformed during overmoulding of the body onto the outside of the carrier member, which deformation is not present when the electrode carrier member is in a relaxed state.
52. An assembly, comprising: an electrode contact; an electrode carrier member; and a protrusion arrangement on an outside of the carrier member extending around an overmoulded body attached to the outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
53. An assembly, comprising: an electrode contact; an electrode carrier member; and a protrusion on an outside of the carrier member extending around a therapeutic substance attached to the outside of the carrier member, wherein the assembly is an implantable stimulating assembly.
54. An assembly, comprising: an electrode contact; an electrode carrier member; and a body including a therapeutic substance, the body overmoulded onto the outside of the carrier member, wherein the assembly is an implantable stimulating assembly, and a boundary of the body is established by a material of the electrode carrier member being deformed during overmoulding of the body onto the outside of the carrier member, which deformation is not present when the electrode carrier member is in a relaxed state.
55. An assembly, comprising: an electrode contact; an electrode carrier member; and a protrusion on an outside of the carrier member extending to enclose an area on the carrier member on an opposite side from the electrode contact, wherein the assembly is an implantable stimulating assembly.
56. An assembly and/or apparatus, wherein at least one of: the assembly and/or apparatus comprises a plurality of electrode contacts; the assembly and/or apparatus comprises an electrode carrier member; the assembly and/or apparatus comprises a protrusion extending about at least two of the plurality of electrode contacts on an outside of the carrier member; the assembly is an implantable stimulating assembly; the assembly is a cochlear implant electrode array; the protrusion is a monolithic part of the electrode carrier member; the plurality of electrodes includes at least three electrodes; and with respect to location along the vector, the protrusion extends past the at least three electrodes; the assembly includes a body overmoulded onto the carrier member, the body being inside a perimeter of the protrusion; the electrode carrier member is an elongate carrier member; the protrusion is an endless protrusion; the protrusion is made out of silicone; the protrusion bounds and surrounds a lower area relative to the barrier; the assembly and/or apparatus comprises a receiver-stimulator of a cochlear implant; the electrode carrier member is made out of silicone; the assembly and/or apparatus comprises a plurality of electrodes; a raised area on an outside of the carrier member; the apparatus is a cochlear implant electrode array; the plurality of electrodes are arrayed in a longitudinal direction of the cochlear implant electrode array; the raised area extends in the longitudinal direction contiguous with at least two electrodes; the plurality of electrodes includes at least 14 electrodes arrayed along the longitudinal direction; with respect to location along the longitudinal direction, the barrier extends past the at least 14 electrodes; the raised area and a portion of the carrier member proximate the raised area form an elongate basin on the outside of the electrode carrier member; the raised area includes a first section and a second section spaced away from the first section, both the first section and the second section extending in the longitudinal direction; the apparatus includes a section lower than the raised area between the first section and the second section; the raised area includes a third section and a fourth section spaced away from the third section, the third section linking the first and second sections at a first location and the fourth section linking the first and second sections at a second location opposite the first location relative to the longitudinal direction; the lower section is between the third section and the fourth section; a plurality of raised sections are located between the first and second sections, the raised sections being raised relative to the section lower than the raised area; the raised area is resiliently compressible; the raised area forms a boundary of a material containing a therapeutic substance, the material overmoulded onto the electrode carrier member; the assembly and/or apparatus comprises an electrode contact; the assembly and/or apparatus comprises an electrode carrier member; and the assembly and/or apparatus comprises a protrusion on an outside of the carrier member forming at least a portion of an arrangement that bounds an area on an outer surface of the carrier member; the assembly is an implantable stimulating assembly; the protrusion is on an opposite side of the electrode carrier member from the electrode contact; the protrusion on the outside of the carrier member extends to enclose an area on the carrier member; the protrusion is a sealing bump; the assembly includes at least 7 electrodes arrayed along a length of the carrier member; with respect to location along a longitudinal axis of the carrier member, the protrusion extends past the at least 7 electrodes; the protrusion follows a path with at least two elongate portions; the protrusion is configured to form a closed reservoir for a material when the material is overmoulded onto the carrier member; the assembly includes a plurality of raised portions inside a boundary established by the protrusion; the plurality of raised areas extend above a body overmoulded onto the carrier member; the body is a material made up of at least silicone and a therapeutic substance dispersed in the silicone of the body; a first cross-section of the electrode carrier member lying on a plane that is normal to a first axis of the electrode carrier member includes a first portion of a teardrop outer profile of the protrusion; a second cross-section of the electrode carrier member lying on a plane that is normal to a second axis of the electrode carrier member that is normal to the first axis of the electrode carrier member includes a second partial teardrop outer profile of the protrusion and a third partial teardrop outer profile of the protrusion; an outer profile of the second cross-section of the electrode carrier member is symmetrical about a plane lying on and parallel to the first axis; the assembly and/or apparatus comprises a body including a therapeutic substance, the body overmoulded onto the outside of the carrier member; a stress riser exists at a majority of the lateral boundary of the body owing to elastic memory of the electrode carrier member; the assembly and/or apparatus comprises a barrier extending on an outside of the carrier member; the barrier extends at least one of on a side of the carrier member different than a side on which centers of the electrode contacts are located; or with the carrier member in a straightened orientation, a direction generally parallel to a vector extending through at least two of the electrode contacts of the plurality of electrodes and past the at least two electrodes; the assembly is an implantable stimulating assembly; the assembly is a cochlear implant electrode array; the barrier is a monolithic part of the electrode carrier member; the plurality of electrodes includes at least three electrodes; with respect to location along the vector, the barrier extends past the at least three electrodes; the assembly includes a body overmoulded onto the carrier member, the body being inside a perimeter of the barrier; the electrode carrier member is an elongate carrier member; the barrier is a means for sealing for an overmoulding process; the barrier bounds and surrounds a lower area relative to the barrier; the barrier bounds and surrounds a body overmoulded onto the carrier member; the body contains a therapeutic substance; the protrusion and/or barrier begins over or proximal to or distal to any one of electrodes El, E2, E3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 or E22 and and/or ends over or proximal or distal to any one of electrodes El, E2, E2, E3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, E21 or E22; each electrode is spaced from the other by a distance of less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75 or 3 mm or any value or range of values therebetween in 0.01 mm increments (from the center of each electrode or from the closest points of each electrode), and the spacing need not be the same; the assembly or an apparatus that includes at least one and less than or greater than or equal to 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, or any value or range of values in 1 increment or more electrodes; the protrusion is part of a protrusion arrangement on the electrode array and there is one, two, three, four, five, six, seven, eight, or any value or range of values therebetween in one increment or more protrusion arrangements on the electrode array; the protrusion encompasses an area and is unbroken; the protrusions are contoured with the overall body of the carrier member; the protrusions are monolithic with the remainder of the carrier member; there are segmented protrusions located within an enclosed area enclosed by the protrusion; there are 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30, or any value or range of values therebetween in one increment or more segmented protrusions included in the enclosed area; there are four protrusions that collectively form an enclosed area; there are four protrusions spaced apart from one another, which four protrusions are part of a protrusion arrangement that enclosed an area on the array; the protrusion follows a path that is pill shaped or otherwise racetrack shaped; the protrusion is located on a side of the array opposite the electrode contact(s); the raised area includes a first section and a second section spaced away from the first section, both the first section and the second section extending in a longitudinal direction of the electrode array; the apparatus includes a section lower than the raised area between the first section and the second section; the raised area and a portion of the carrier member proximate the raised area form an elongate basin on the outside of the electrode carrier member; the raised area includes a third section and a fourth section spaced away from the third section, the third section linking the first and second sections at a first location and the fourth section linking the first and second sections at a second location opposite the first location relative to the longitudinal direction, the lower section is between the third section and the fourth section; there are more than four sections that make up the raised area, or at least more than four distinctly different sections; the protrusion extends in a seamless manner to enclose an enclosed area; the enclosed area does not include an electrode; a height of the electrode array can be less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 or any value or range of values therebetween in 0.01 mm increments; a width of the electrode array can be less than, greater than or equal to 0.1, 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 or any value or range of values therebetween in 0.01 mm increments; a depth of an area recessed to receive the overmoulded body can be less than, greater than or equal to 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29 or 0.30 mm or any value or range of values therebetween in 0.005 mm increments; a width of the overmoulded body can be less than, greater than or equal to 0.1 , 0.15, 0.2, 0.25, 0.3, 0.35, 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, 0.95, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5 mm or any value or range of values therebetween in 0.01 mm increments; a distance from the top of protrusion portion to the top of the overmolded body can be less than, greater than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 40, 45 or 50 micrometers or any value or range of values therebetween in 0.1 micrometer increments; a height of the protrusion is less than, greater than or equal to 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 or 35 micrometers or any value or range of values therebetween in 0.1 micrometer increments; a radius of curvature of the protrusion, can be less than, greater than or equal to 0.01, 0.02, 0.03, 0.04, 0.05, 0.06, 0.07, 0.08, 0.09, 0.10, 0.11, 0.12, 0.13, 0.14, 0.15, 0.16, 0.17, 0.18, 0.19, 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, 0.30, 0.31, 0.32 or 0.33 mm or any value or range of values therebetween in 0.005 mm increments; a percentage of the outer periphery of the array formed by the protrusion, with respect to a cross-section of the array normal to the longitudinal axis, is less than, equal to or greater than 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,1 6, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, or 30%, or any value or range of values therebetween in 0.1% increments or more; with respect to outside of the electrode array, the protrusion has a convex portion and a concave portion; the protrusion is blended into the remainder of the carrier member; at least one side of the protrusion is blended into the remainder of the carrier member; the protrusion rises abruptly from the carrier member on both sides of the protrusion; an outer surface of the protrusion has a constant radius for at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of value therebetween in 1% increments; the protrusion includes a linear surface; the overmolded material is a material that includes a therapeutic substance; the therapeutic substances could be Dexamethasone, base, acetate, sodium phosphate, Prednisone, Fluticasone, Other cortico steroids, BDNF/NT3 Gene therapy (or other biologies; the silicone could be a biocompatible silicone excipient with a durometer of 5-80 shore A, Nusil, DDU-4320, DDU-4870, Elkem D125, D140; the overmoulded body is configured to dissolve in part to transfer the therapeutic substance into the cochlea / the perilymph of the cochlea; the therapeutic substance or drug can elute from the overmoulded body; the overmolded body can extend a distance that is equal to less than, or greater than, or equal to 150, 140, 130, 120, 110, 90, 80, 70, 60, 50, 40, 30, 20 or 10% or any value or range of values therebetween in 1% increments of the distance spanned by the electrodes of the electrode array; the stress riser exists at at least 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, or 100%, or any value or range of values therebetween in 1% increments of the lateral boundary of the body; the overmould body material is a combination of silicone and a therapeutic substance; the assembly or apparatus is made in part using injection moulding, wherein a mixture of therapeutic substance and silicone is injected into a mould, where a dispersion of the therapeutic substance in the silicone is uniform or substantially uniform, and thus when the silicone sets or otherwise cures, the dispersion of the therapeutic substance within the cure silicone is also uniform; the therapeutic substance elutes and/or diffuses out of the silicone and into the body of the recipient, such as when the array is an implantable array; the material of the overmoulded body can be any therapeutic substance delivery silicone based materials currently available, such as those that are utilized with cochlear implant electrode arrays, such as, for example, a . l%-50% w/w therapeutic substance (e.g., drug) loaded silicone; the protrusion(s) form a barrier for the overmould material during the moulding process; the apparatus or assembly is devoid of glue holding the therapeutic substance to the carrier / the overmoulded material to the carrier; the overmolded body can extend a distance that is equal to, less than, or greater than 150, 140, 130, 120, 110, 90, 80, 70, 60, 50, 40, 30, 20 or 10% or any value or range of values therebetween in 1% increments of the length of the first electrode to the last electrode of the array; the protrusion forms a closed reservoir for the therapeutic substance / material containing the substance when the therapeutic substance is overmoulded on to the carrier member; the overmoulded material with the therapeutic substance is injection mouldded so the drug loaded silicone is moulded directly onto the carrier member; the barrier / protrusions / raised portions prevent the material containing the therapeutic substance from leaking or flashing to other parts the electrode array where such is not desired, such as for example, to the electrode contacts; the protrusions / barrier / raised portions provide a structure that mimics the function of an O-ring; the therapeutic substance containing material is located only on one side of the carrier member; with respect to a cross-section normal to the longitudinal axis, the therapeutic substance containing material and/or the outermost portions of the barrier / protrusion arrangement subtends an angle no more than 145, 140, 135, 130, 125, 120, 115, 110, 105, 100, 95, 90, 85, 80, 75, 70, 65, 60, 55, 50, 45, 40, 35, 30 or 25 degrees or any value or range of values therebetween in 1 degree increments; or the apparatus or assembly is made by a method wherein one or more of: the method includes obtaining a cochlear implant electrode array; the method includes placing the electrode array in a mould cavity; and the method includes overmoulding a substance onto a portion of the array to form a modified cochlear implant electrode array, the mould cavity forming an exterior surface of the substance; during the action of overmoulding, the substance is halted from traveling past a discrete location on the cochlear implant electrode array so that there is another portion of the array without the substance; the substance includes a therapeutic substance; the method includes identifying, before the action of overmoulding, an amount of the therapeutic substance to be overmoulded onto the array to form the modified cochlear implant electrode array; upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 20% of the identified amount; upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 10% of the identified amount; upon completion of the overmoulding action, an amount of therapeutic substance overmoulded on the modified cochlear implant electrode array is within +- 5% of the identified amount; the method includes repeating the actions of obtaining, placing, overmoulding and identifying at least 10 times within a 24, 48, 72, 96, 150, 200, 250, 300, 400, 500 or 600 hour period; the mould cavity includes a structure that compresses the electrode array over a defined discrete area that encloses another area during the overmoulding, the compression being more than areas adjacent the discrete area; and the another area is where the substance is overmoulded; the mould cavity includes a structure that deforms the electrode array over a defined discrete area to form a barrier that halts the substance from traveling past the discrete location; the electrode array includes a structure that is compressed over a defined discrete area that encloses another area during the overmoulding, the compression being more than that at areas adjacent the discrete area and the another area is where the substance is overmoulded; the electrode array includes a structure that deforms when in the mould cavity, the deformation forming a barrier that halts the substance from traveling past the deformed structure.
EP24759838.6A 2023-02-22 2024-02-15 ELECTRODE ARRANGEMENT WITH SURFACE CHARACTERISTICS Pending EP4669414A1 (en)

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PCT/IB2024/051443 WO2024176057A1 (en) 2023-02-22 2024-02-15 Electrode array with surface features

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AT507045B1 (en) * 2002-11-29 2010-04-15 Cochlear Ltd IMPLANTABLE, TISSUE-STIMULATING DEVICE
US7937154B2 (en) * 2005-12-08 2011-05-03 Cochlear Limited Promoting curvature and maintaining orientation of an electrode carrier member of a stimulating medical device
CN102985003B (en) * 2010-06-30 2015-04-01 Med-El电气医疗器械有限公司 Spiral lug implant electrode
US20120265159A1 (en) * 2011-04-12 2012-10-18 Velcera, Inc. Device for storing and dispensing a medicament
US8504169B2 (en) * 2011-05-13 2013-08-06 Cochlear Limited Drug retaining surface features in an implantable medical device

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