Advanced Bionics Corporation

Thomas H R Lenarz

Janusz A Kuzma

Alfred E Mann

Thomas J Balkany

Rolf-Dieter Battmer

Michael Allen Faltys

Chuladatta Thenuwara

Mark B Downing

William Vanbrooks Harrison

An exemplary insertion tool configured to facilitate insertion of a lead into a bodily orifice includes a handle assembly configured to facilitate handling of the insertion tool, an insertion assembly coupled to the handle assembly and comprising a rigid holding tube configured to removably couple to a portion of the lead, and a release assembly disposed at least partially within the handle assembly and comprising a release button. The release assembly is configured to release the lead from the holding tube in response to user actuation of the release button. Corresponding insertion tools, systems, and methods are also described.

Lead insertion tools

A threaded grommet, having an axial passageway therethrough, and made from a biocompatible material, such as titanium, is screwed into a cochleostomy made in the bony tissue adjacent the round window in order to provide a minimally-invasive access port into the cochlea. The threads included on the outside of the grommet engage the bony tissue and form a tight seal that holds the grommet securely in position. Such tight seal prevents cochlear fluids from escaping from inside of the cochlea. The axial passageway through the center of the grommet provides an opening, i.e., mechanical access, into the base end (the end of the cochlea nearest the round window) of the cochlea. Drugs, steroids, tissue-growth-inhibiting fluids, and the like, may be controllably delivered through the access hole into the cochlea, which access hole may be plugged when not needed. Additionally, an electrode array, e.g., a relatively short electrode array may, be inserted into the cochlea through the access hole. A preferred electrode array has from four to eight electrode contacts spaced apart along a flexible carrier. The flexible carrier is about 6-8 mm in length. The electrode contacts may be connected, in conventional manner, to suitable implantable cochlear stimulator (ICS), or equivalent pulse generator. Neither the grommet nor the short electrode array interfere with the normal hearing processes within the cochlea. Hence, both electrical stimulation and normal hearing processes may occur simultaneously within the cochlea.

Minimally-invasive access into the cochlea for electrode insertion and fluid delivery

An implantable electrode assembly includes a leading section attached to the distal end of an electrode array. The electrode array has electrodes spaced along its length. Cochleostomies are drilled at both the base and apex of the cochlea. The leading section is inserted through the basal cochleostomy and promoted to the apical cochleostomy. A forward end of the leading section is then pulled through the apical cochleostomy, which causes the electrode array to be pulled into the cochlea. A depth marker on the electrode array indicates complete insertion. The leading section is detached from the electrode array and the electrode array is placed in tension by gently pulling both ends, which tension causes the electrode array to hug the modiolar wall of the cochlea. Wedges may be inserted at both cochleostomies to maintain the electrode array in tension.

Apex to base cochlear implant electrode

An electrode system is provided for insertion into an ossified cochlea. The electrode system includes a first electrode array and a second electrode array, both of which are electrically connected to a suitable implantable cochlear stimulator (ICS). Each of the two electrode arrays has a plurality of spaced-apart electrode contacts along one side or surface thereof, e.g., eight to twelve electrode contacts on the first electrode array, and six to ten electrode contacts on the second electrode array. A tunnel is drilled through the ossified portion of the cochlea into which the first electrode array is snugly inserted. The second electrode array is inserted into the cochlea near the second turn thereof. Where the cochlea is fully ossified, a second tunnel is drilled through the ossified portion at the second turn. A positioner may be used with the second electrode array in order to position its electrode contacts against the modiolar wall of the cochlea. The first and second electrodes may be inserted into the scala tympani and/or the scala vestibuli of the cochlea.

Electrode system for ossified cochlea

An electrode array suitable for insertion into the cochlea has a drug delivery channel therein. In a preferred embodiment, electrical stimuli may be applied near the modiolar wall of the cochlea via spaced-apart electrode contacts embedded along a front edge of a flexible carrier, which flexible carrier comprises the body of the electrode array. The front edge, and hence the electrode contacts, may be held against the modiolar wall by a flexible positioner placed on the back side of the flexible carrier. Drugs may be delivered deep into the cochlea through the drug delivery channel that passes longitudinally through the center of the flexible carrier. In an alternative embodiment, the drug delivery channel may be included within the positioner.

Cochlear electrode with drug delivery channel and method of making same

The present invention provides a fully implantable cochlear implant system (FICIS) that allows various configurations of different modules to be combined so as to meet the needs of a particular patient, including very young patients. At least three main modules are used in the FICIS, including (1) a small implantable cochlear stimulator (ICS) module, with permanently attached cochlear electrode array; (2) an implantable speech processor (ISP) module, with integrated microphone and rechargeable battery; and (3) an external module. In one embodiment, the external module may comprise an external speech processor (ESP) module. In another embodiment, the external module may comprise an external battery charger (EBC) module. The ICS and ISP modules are configured to facilitate long time reliable use of the ICS module, e.g., for the lifetime of the patient, and low-risk, relatively easy replacement of the ISP module.

Fully implantable cochlear implant system

An inflatable cochlear electrode array adapted for insertion into a human cochlear includes a flexible carrier on which a multiplicity of spaced-apart electrode contacts are carried, preferably along one side, e.g., a medial side, of the carrier. The flexible carrier also includes an inflatable compartment or section. In one embodiment, the inflatable section is located at the distal tip of the electrode array on a side of the flexible carrier that is opposite the electrode contacts. In another embodiment, the inflatable compartment or section is located along at least one half of the full length of the flexible carrier, forming a spine. In either embodiment, the electrode is readily inserted into the cochlea to a desired depth while the inflatable compartment or section remains in a deflated state. Thereafter, a desired modiolus-hugging position is achieved by inflating the inflatable compartment or section by injecting therein a suitable biocompatible fluid. A method of making an inflatable cochlear electrode is also disclosed.

Inflatable cochlear electrode array and method of making same

A stapedius electrode attaches to or is embedded within the stapedius muscle (,) at a point near where the stapedius muscle is visible as it exits a bony channel (,) within the middle ear. In one embodiment, the electrode is made from a biocompatible metal wire formed into a flat blade (,) having a sharp tip (,) and serrations (,) along one edge. An insulated lead attaches electrically and mechanically to the blade. Such attachment may be made by welding and wrapping the insulated lead at one end of the wire around the body of the electrode and protecting such weld and securing such wrappings with a coating or blob of epoxy. During implantation of the electrode, the electrode blade is inserted through a small slot made in the muscle tissue. Alternatively, the electrode may be inserted alongside the muscle tissue through an opening in the bony wall as it passes through the bony channel, with a tip of the electrode protruding from the bony channel. The protruding tip is then bent over to lie against the bony wall, and hold the electrode in place. Other embodiments of a stapedius electrode are also presented. such as the distal end (,) of a multistrand insulated wire (,) that is embedded in the stapedius muscle tissue (,) using a delivery needle (,). A tube connector (,) may be used to electrically connect a lead coming form the implanted stapedius electrode to an implant device. The tube connector (,) includes a platinum tube (,) welded at one end to a lead (,) coming from the implant device. A proximal end (,) of the lead from the electrode is crimped to the other end of the tube (,). A silicone tube or sleeve (,) is then placed over the tube and sealed at both ends.

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Hannover, Germany

Thomas H R Lenarz