Abstract: According to an embodiment, a medical device is disclosed. The medical device includes an external unit and an implantable unit. The external unit includes an electronic unit operationally coupled to a transmitter coil that is configured transmit power and/or data signal over a wireless transcutaneous link, a coil unit comprising a loop structure with the transmitter coil being wound around and along at least a part of length of the loop structure, and a fixation unit configured to attach the loop structure to a user's body i) proximal to an implantable receiver coil that is configured to be implanted within a body part, and ii) around a body part of a user such that a part of the body part is positioned in a hollow section of the loop structure.

Abstract: Spinal bone anchor attachment device for improving the attachment of a bone screw to skeletal portions of a patient, the device reducing the risk of screw failure, and improving patient outcomes. The device is composed of a biomaterial compatible with bone and provides an enhanced surface area on outer surfaces of the device for engaging the bone, and an enhanced surface area within the device for engaging the bone screw. The device may also have a guiding slanted tip with a bias element for facilitating the placement of the device into bone tissue and rescuing an improper tract. The device may further be used to secure the placement of pedicle screws, and as a component of an intervertebral stabilization system commonly used in spinal fusion surgeries.

Abstract: A method of treating a patulous Eustachian tube includes forming a first pocket in a wall of a nasopharynx region proximate to a pharyngeal ostium, inserting a resiliently biased implant within the first pocket, and allowing the resiliently biased implant to expand within the first pocket to thereby urge the Eustachian tube towards a closed state. The wire implant may include a resilient stent or other resilient wire structure. In some versions, a deployment device having a balloon is used to deploy a malleable implant. This deployment device has a malleable implant disposed around the balloon, which is disposed around a guide catheter. The balloon is inflated and expands the malleable implant. The malleable implant retains the expanded shape and urges the Eustachian tube toward a closed state.

Abstract: Described here are delivery devices for delivering one or more implants to the body, and methods of using. The delivery devices may deliver implants to a variety of locations within the body, for a number of different uses. In some variations, the delivery devices have a cannula with one or more curved sections. In some variations, a pusher may be used to release one or more implants from the cannula. In some variations, one or more of the released implants may be a self-expanding device. Methods of delivering implants to one or more sinus cavities are also described here.

Abstract: A hand-held device is used to deliver and hydrate a temporary polymeric implant having a length, an outer surface and a cross-section, with a disruptable cover over the implant. A lumen may pass through the entire length, the lumen having a surface forming an equivalent diameter in the polymeric stent. The temporary polymeric implant includes a first aqueous-swellable, biocompatible and biodegradable composition (e.g., polymer) having a thickness. The aqueous-swellable and biodegradable polymer retaining structural integrity for at least 1 hours up to thirty days when swollen and kept moist by a moist aqueous environment. Barrier layers of biodegradable polymer(s) may be used to prevent migration of liquids into the lumen.

Abstract: The present disclosure provides a bioresorbable foam closure device for trans-nasally closing an opening in a base of a skull. The closure device comprises a phase-separated polymer having a porosity of greater than 80%. The device includes a stem portion having a proximal end and a distal end, and a head portion at the distal end of the stem portion. The closure device is deformed from a free shape to a constricted shape, inserted through a nasal cavity and into the opening, and released to at least partially revert back to the free shape such that the stem portion fills the opening and the head portion abuts cranium and dura to secure the closure device in position and seal the opening.

Abstract: The present invention relates to the preparation of a membrane for use in the repair of the middle ear including perforations and damage to the tympanic membrane. More particularly, the invention provides for compositions and methods for preparing silk fibroin biocompatible polyurethane membranes using a solvent, which have improved biodegradation, mechanical and vibroacoustic properties.

Abstract: This disclosure features artificial tympanic membrane graft devices and two-component bilayer graft devices that include a scaffold having a plurality of ribs made of a first material and a plurality of spaces between the ribs filled or made with the first material, a different, second material, a combination of the first and a second materials, or a combination of a second material and one or more other different materials. The bilayer graft devices have two components or layers. One component, e.g., the underlay graft device, can include a projection, and the second component, e.g., the overlay graft device, can include an opening that corresponds to the projection (or vice versa) so that the opening and the projection can secure the two layers together in a “lock and key” manner. This disclosure also features methods of making, using, and implanting the three-dimensional artificial tympanic membrane and bilayer graft devices.

Abstract: A tympanic membrane prosthesis includes a tubular body having a lumen extending therethrough and open at each of a proximal and distal end. The tubular body forms a structurally self-supporting, body compatible, and body absorbable device. The device is formed of a composite structure that includes an inner portion having an inside surface and an outer portion having an outside surface. The inside surface forms at least a portion of the lumen extending through the tubular body. The inside surface is adapted to provide less resistance to fluid flow than the outside surface. The outside surface is adapted to produce an inflammatory reaction in adjacent tissue at a tympanic membrane. The device is adapted for insertion into an opening through the tympanic membrane for placement with the proximal end and the distal end disposed on opposite sides of the tympanic membrane.

Abstract: Described are implants for placing in a body, tools for delivering the implants, and systems and methods for using implants and tools for placing in a body and more particularly to nasal implants, tools for delivering nasal implants, and systems and methods for using such implants and tools.

Abstract: Ear implants for auricular tissue reconstruction in a patient are provided. The ear implant may be a tissue scaffold multicomponent assembly for reconstruction of auricular tissue. Thus, the assembly may include both a first and a second tissue scaffold component. Each comprises a biocompatible polymeric material having a plurality of open pores configured to support cell growth. The first tissue scaffold component defines a central void region and at least a portion of an outer ear framework of the patient after implantation. The second tissue scaffold component defines a base portion. After implantation into the patient, the second tissue scaffold component seats within the central void region of the first tissue scaffold component, so that the second tissue scaffold component is secured to the first tissue scaffold component. Methods for reconstructing auricular tissue in a patient using such ear implant tissue scaffolds are also provided.

Abstract: A tympanostomy tube placement device has a stem with a needle having a tip configured to pierce a tympanic membrane. A retainer is on the needle and includes four fingers extending axially at a distance from said axis and at 90° circumferential separations in one example. The retainer is movable from a distal position at which it presses radially inwardly against the tube distal flange tabs to retain the distal flange in a folded position, to a proximal position at which the tube distal flange is free to spring out radially to a deployed position. The retainer fingers extend through tube proximal flange passageways and press the tube distal flange inwardly, while leaving a distally-facing face of the proximal flange exposed radially outwardly of the retainer. Hence, the proximal flange has its final deployed configuration throughout, and so can act as a physical stop member against the tympanic membrane and also provides visualisation for the surgeon because it extends radially outwardly of the stem.

Abstract: The disclosure related to an implant comprising a substrate, a housing, wherein the housing is disposed on the substrate, an electronic circuit disposed on the substrate inside the housing, an electronic component disposed on the substrate outside the housing, and a conductor track, wherein the conductor track connects the electronic circuit to the electronic component. The conductor track is embedded into the substrate at least in sections in such a way that at least one section of the conductor track is completely surrounded by the substrate. Furthermore, a method for creating an implant is disclosed.

Abstract: Wires and coils within an electrode assembly electromagnetically interact and cause mechanical motion of the assembly. This mechanical motion can be used to supplement or replace the electrical stimulation provided by a standard cochlear implant and provides targeted acoustic stimulation to the cochlea.

Abstract: An apparatus and method for implanting and securing an implanted medical device in a recipient. The implantable medical device of the generally includes an electrode assembly that comprises an elongate carrier member having at least one stimulating electrode positioned thereon. The carrier member further has a fixation structure positioned thereon configured to interact with a portion of the rigid structure to longitudinally secure the carrier member in the recipient.

Abstract: The neural interface system of the preferred embodiments includes an electrode array having a plurality of electrode sites and a carrier that supports the electrode array. The electrode array is coupled to the carrier such that the electrode sites are arranged both circumferentially around the carrier and axially along the carrier. A group of the electrode sites may be simultaneously activated to create an activation pattern. The system of the preferred embodiment is preferably designed for deep brain stimulation, and, more specifically, for deep brain stimulation with fine electrode site positioning, selectivity, tunability, and precise activation patterning. The system of the preferred embodiments, however, may be alternatively used in any suitable environment (such as the spinal cord, peripheral nerve, muscle, or any other suitable anatomical location) and for any suitable reason.

Abstract: This disclosure relates to a hearing aid for placement on head of a user comprising a first second part. The first part may comprise an acoustic input transducer adapted to convert ambient sound picked up at the ear of the user to an electric signal, a signal processor adapted to process the electric signal according to specifications of user into a processed electric signal, and an output transducer adapted to covert the processed electric signal into a transmission signal, The second part may comprise an anchor adapted to fixate said second part under the skin to skull bone of the user, and a receiver adapted to receive the transmission signal and convert the transmission signal to an output signal perceivable as sound by the user. The first part may comprise an inner recess adapted to receive an insert element, where the insert element may comprise a first magnet adapted to in cooperation with the second part to cause the first part to attach to the head of the user.

Abstract: Nasal implants are provided that have a planar type profile with open spaces through portions of the planar type profile. The nasal implant can be compressible along one or more dimensions of the nasal implant, such as the width and length of the planar type profile. Delivery tools for deploying the nasal implants within the nasal tissue are also provided. Methods for deploying the nasal implants within the nasal tissue of the patient are also provided.

Abstract: The present invention relates to methods for bioresorbable and biodegradable casings having both micropores and macropores for providing shape, structure and containment to different bone grafting materials. Kits and methods of use are also described.

Abstract: The invention relates to a shape-adaptive medical implant having at least one actuator, which the implant can be changed from a first implant geometry to a second implant geometry, the implant having a different geometric shape in the second implant geometry from that in the first implant geometry, wherein the actuator has a swellable chemical substance which swells when supplied with liquid, and wherein the implant which is designed to supply liquid present outside the implant to the swellable chemical substance. The invention also relates to the use of an electrical signal source.

Abstract: A tympanic construct fabricated from at least one amniotic membrane, at least one chorionic membrane, or at least one amniotic membrane and at least one chorionic membrane obtained from human birth tissue is provided. Methods of preparing a tympanic construct, methods of repairing tympanic membrane defects and surgical sites, as well as kits for the same are also provided.

Abstract: A tympanoplatic patch applicator comprising: a handle disposed with a deployment control; a deployment stem comprising multiple nested sleeves connected to the handle; a patch configured to be affixed to the distal end of the deployment stem via an actuation filament embedded in the deployment stem; and a filament-based deployment system controllable by the deployment control, wherein the deployment stem is configured to position the patch at the internal side of a perforated tympanic membrane in the middle ear by introducing the patch into the ear canal and penetrating the perforated tympanic membrane with the distal end of the deployment stem, and wherein the filament-based deployment system is configured to release the patch from the distal end of the deployment stem, thereby deploying the patch on the internal side of the perforated tympanic membrane.

Abstract: A round window coupling device is described for a hybrid electric-mechanical stimulation hearing implant system. A rigid outer shell securely fits into a round window niche in a cochlear outer surface of a recipient patient. An electrode groove in the outer surface of the outer shell snuggly fits around a portion of a cochlear implant electrode array passing through the round window niche. A coupling filling is enclosed within the outer shell to couple mechanical vibrations from the proximal end to the distal end with minimal attenuation. A transducer receiver at the proximal end connects to and receives vibrations from a drive surface of a mechanical transducer. And a drive face at the distal end interfaces to perilymph fluid within the cochlea of the recipient patient to deliver vibrations from the coupling filling to the perilymph fluid with minimal attenuation for perception as sound.

Abstract: A middle ear prosthesis is made of a stiff deformable material and includes a planar head end with a central portion having a central diameter. The head end is adapted for engagement with a tympanic membrane from the middle ear of an implanted patient. An opposing pair of U-shaped stapes engagement legs bend down from the central portion so that an end distance between ends of the engagement legs is less than the central diameter. The engagement legs are adapted for adjustable length engagement with the stapes in the middle ear of the implanted patient. The head end and the engagement legs are adapted to transmit vibrations from the tympanic membrane to the stapes for perception as sound by the implanted patient.

Abstract: [Problem] The present invention provides a voice disorder treatment tool in which a clamping section thereof does not break easily. [Solution] The present invention includes a plurality of clamping sections 1, 1 that are provided with a front surface piece 1b disposed on a front surface 11a of incised thyroid cartilage 11 and a rear surface piece 1c disposed on a rear surface of the thyroid cartilage 11, and fit to cut ends 12 of the incised thyroid cartilage 11 that are facing each other, and a bridging section 2 that connects the plurality of clamping sections 1, 1. The front surface piece 1b includes a bending region 15 deformable about a virtual line K extending in a width direction of this front surface piece 1b, and the bending region 15 has a reinforcing structure S.

Abstract: The devices described herein are used for holding an undelay graft and an overlay graft in place for repair a tympanic membrane. The devices include a post having a proximal end and a distal end; and first and second arms, each having a proximal end and a distal end. The distal end of the post is flexibly joined to the proximal end of the first arm and to the proximal end of the second arm. When the device is in a deployed configuration, the first arm and the second arm extend substantially perpendicularly from the post; and when the first arm and the second arm are clamped into a constrained configuration, the first arm and the second arm extend substantially parallel to a central axis of the post.

Abstract: This disclosure features artificial tympanic membrane graft devices and two-component bilayer graft devices that include a scaffold having a plurality of ribs made of a first material and a plurality of spaces between the ribs filled or made with the first material, a different, second material, a combination of the first and a second materials, or a combination of a second material and one or more other different materials. The bilayer graft devices have two components or layers. One component, e.g., the underlay graft device, can include a projection, and the second component, e.g., the overlay graft device, can include an opening that corresponds to the projection (or vice versa) so that the opening and the projection can secure the two layers together in a “lock and key” manner. This disclosure also features methods of making, using, and implanting the three-dimensional artificial tympanic membrane and bilayer graft devices.

Abstract: A cochlear implant for processing signal parameters which are adapted for controlling the cochlear implant, which are based on the audio signal and which enable generating a representation of the audio signal by the cochlear implant includes a receive interface which is implemented to receive the signal parameters and a nerve stimulator for processing the signal parameters to generate nerve cell stimulation signals based on the signal parameters. A device for generating a control signal for a cochlear implant on the basis of an audio signal includes a cochlear parameter extractor for analyzing the audio signal which is implemented to generate signal parameters as input information for the cochlear implant based on an analysis of the audio signal using a human hearing simulation model, and a transmit interface for transmitting the signal parameters to the cochlear implant.

Abstract: This disclosure relates to systems and methods for performing ossicular reconstructions. An exemplary ossicular reconstruction system may include one or more adjustable prosthetic devices and micro-measuring devices. The adjustable prosthetic devices may be adjusted in terms of length, angulation, or both.

Abstract: Provided herein are various connectors that allow for translating the axial movement of an implantable hearing transducer from a first direction to a second direction. In various arrangements, these connectors form a spanning connector that extend across a portion of a tympanic cavity of a patient. One end of the connector can be affixed to the tympanic cavity, and a second end may engage an auditory component. In such an arrangement, a vibratory actuator may engage the connector between the first and second ends. Such an arrangement can provide improved alignment of actuator movement with a direction of movement of an auditory component.

Abstract: A medical implant, such as an implantable component (22) of a tissue-stimulating prosthesis. One example of such a prosthesis being a cochlear implant. The component (22) is adapted to be implanted at or adjacent a tissue surface within the recipient, such as a bone surface. The component (22) has a housing and at least one flange (42) extending outwardly therefrom. The flange (42) can be secured to the tissue surface via a tissue fixation device, such as a bone screw (43).

Abstract: A method for non-surgically treating an internal nasal valve of a patient comprising, injecting a working device into the internal nasal valve of the patient, wherein the injected working device in the nasal tissue causes an alteration of an internal or external nasal valve. A device introduced by injection into the nose, allowing for structural support or filling of defects in the nose, and causing a change in external shape of the nose. The device and inserts and implants described also have use in cosmetic applications relating to the facial tissue.

Abstract: A method, systems, and devices are disclosed. An example method includes determining whether an external unit of an implanted medical device is coupled to an implanted unit of the implanted medical device. In response to determining that the external unit is coupled to the implanted unit, the example method includes causing the external unit to operate in a first operating mode. In response to determining that the external unit is not coupled to the implanted unit, the example method includes causing the external unit to operate in a second operating mode.

Abstract: A color-coded bioprosthetic valve system having a valve with an annular sewing ring, and a valve holder system with a holder sutured to the ring of the valve, a post operatively connected to the holder, and an adapter sutured to the post and having a color associated with the valve model and/or size. For example, the adapter may be blue to indicate that the valve of the system is a mitral valve of a particular type and/or size. The system may also include a flex handle that is configured to engage with the adapter. The handle has a color associated with the adapter such that a user is able to visually determine that the handle color matches the valve model. For example, the handle may have a grip that is colored blue to match the blue color of the adapter. Accordingly, the color-coded system enables users to confirm easily that the correct accessories such as the sizer or flex handle are being used with the correct valve.

Abstract: A bone conduction device includes split high-frequency and low-frequency actuators. The frequency response of the low-frequency actuator can be restricted to the lower range of hearing frequencies to improve performance. The high-frequency actuator can be implanted under tissue close to the cochlea to improve transmission efficiency, since high-frequency vibrations suffer greater attenuation.

Abstract: Embodiments of a delivery device for inserting multiple implants into an airway of a patient.

Abstract: An implant delivery system can be configured to deliver an inflatable implant into a bladder via a urethra. The delivery system can comprise an elongate tubular body, an inflation tube and an implant decoupler. The tubular body can comprise a central lumen configured to hold an inflatable implant in an initial un-inflated state for delivery of the implant into the bladder. A method of use can include passing a distal tip of the elongate tubular body into the bladder. The implant can be inflated and released into the bladder.

Abstract: An output assembly is sized for placement in the middle and inner ear, such that removal of bone can be decreased. The output assembly may comprise at least one photo detector, a demultiplexer and an electrode array sized to pass through an incision in the eardrum. An input transducer assembly is configured to transmit a multiplexed optical signal to the output assembly. The input assembly can be configured to transmit the multiplexed optical signal through the eardrum, such that tissue removal can be decreased and the device can be placed without removal of bone, for example. The multiplexed optical signal may comprise a pulse width modulated signal so as to decrease the effect of non-linearities of the light source and light detector and provide quality sound to the user.

Abstract: A middle ear implant may include a first interface portion configured to interface with a first structure of a middle ear of a patient, a second interface portion configured to interface with a second structure of the middle ear of the patient, a shaft configured to connect the first interface portion and the second interface portion, and a sensor disposed at one end of the shaft, between the shaft and one of the first interface portion or the second interface portion. The sensor may be configured to provide a DC signal output indicative of static pressure on the sensor based on placement of the sensor between the first and second structures. The sensor may also be configured to provide an AC signal output indicative of a frequency response of the implant in response to the sensor being coupled to an output device.

Abstract: This measurement system is for evaluating an acoustic apparatus (100) that includes a vibrating element (102) and allows sound to be heard via vibration transmission. The measurement system includes an ear model (50) including an artificial ear (51) modeled after a human ear and an artificial temporal bone (57) in contact with the artificial ear (51); and a vibration detection element (56) disposed in the artificial temporal bone (57).

Abstract: Embodiments presented herein are generally directed to arrangements for implantable medical devices. The implantable medical devices may include one or more of a single-body calvaria implant and an implantable microphone subcutaneously implanted in the recipient's forehead region.

Abstract: The invention provides both systems and kits for medical imaging of nerves in the head and neck of a subject.

Abstract: Inner ear treatment delivery devices and methods are disclosed. The device includes a pressurized container filled with a content, a control mechanism within the pressurized container, a nozzle coupled to the control valve, a microprocessor adapted to operate the control valve, and a power source providing energy to the device. The device administers at least one dose of the content to a patient's inner ear.

Abstract: A component of an artificial joint according to an exemplary aspect of the present disclosure includes, inter alia, a base plate and a post selectively removable from the base plate. Further, an outer surface of the post includes a layer of the bone ingrowth material along substantially the entire length of the post.

Abstract: A middle ear implant includes a first interface portion configured to interface with a first structure of a middle ear of a patient, a second interface portion configured to interface with a second structure of the middle ear of the patient, a shaft that connects the first and second interface portions, a carrier plate removably mounted in one of the first or second interface portions, and a removable sensor disposed at one end of the shaft, between the shaft and one of the first interface portion or the second interface portion. The removable sensor is configured to provide a DC signal output indicative of static pressure on the sensor based on placement of the sensor between the first and second structures, and provide an AC signal output indicative of a frequency response of the implant. The removable sensor is disposed at a portion of the carrier plate.

Abstract: In one example, an implantable lead includes a substrate and an electrically conductive material disposed on the substrate to form a flexible circuit. The flexible circuit includes a proximal end adapted to electrically connect to an implantable processor, a distal portion adapted to stimulate a cochlear nerve, and a lead body extending from the proximal end to the distal portion, the lead body having a longitudinal axis and comprising a plurality of electrical traces adapted to carry electrical signals from the proximal end to the distal portion. A flag extension is formed in the substrate and extends laterally outward from the lead body longitudinal axis. A method for forming a cochlear lead with a flag extension is also provided.

Abstract: A tympanic construct fabricated from at least one amniotic membrane, at least one chorionic membrane, or at least one amniotic membrane and at least one chorionic membrane obtained from human birth tissue is provided. Methods of preparing a tympanic construct, methods of repairing tympanic membrane defects and surgical sites, as well as kits for the same are also provided.

Abstract: A prosthesis for insertion in an ear to reduce pain resulting from TMJ disorders. The ear insert has a predefined shape conforming to the shape of the ear canal when the jaw is in an open position. The ear insert supports the TMJ and associated secondary musculature to reduce strain in the TMJ area, including the muscles, ligaments, nerves, and the temporo-mandibular joint itself. The insert is hollow in the inside to permit hearing and is made of a rigid material which retains the shape of the ear canal. A scalloped indenture extends across a surface of the ear insert positioned behind the tragus.

Abstract: An implantable device for mounting to a patient's bone includes a housing and at least one osseointegrating protuberance. The housing includes a surface having an abutting portion configured to abut the bone when the housing is implanted in the patient, the abutting portion defining a housing axis orthogonal to the surface. The at least one osseointegrating protuberance: extends from the surface of the housing; is adapted to abut the patient's bone; and has a substantially smooth shaft.

Abstract: An apparatus and method is provided for reducing middle ear fluid and equalizing middle ear pressure in infants and toddlers. The apparatus coordinates the act of swallowing and the forcing of air into the nostril of the child. The coordinated actions allow air forced into the nostril to traverse the Eustachian tube when in its open state. A flexible member and a main flexible tube, connected accordingly, are both adapted to be inserted into the child's mouth and nostril, respectively, to achieve such coordination and allow air to enter the Eustachian tube when in its open state, ultimately allowing air to reach the middle ear.