Patent Application
20220305252
The present application claims priority to EP Patent Application No. EP21165630, filed Mar. 29, 2021, the contents of which are hereby incorporated by reference in their entirety.
Cochlear implant systems are used to provide, restore and/or improve hearing loss suffered by cochlear implant patients who use the cochlear implant systems. A key component of a cochlear implant system is an electrode lead that is inserted into a cochlea of the patient. A distal end portion of the electrode lead is provided with a plurality of stimulation electrodes for applying a stimulation current to auditory nerve tissue within the cochlea, which is supplied via electrode wires extending through the electrode lead and electrically connecting the respective stimulation electrode with a cochlear implant implanted within the patient at the proximal end of the electrode lead. A proximal portion of the electrode lead may be provided with one or more ground electrodes for providing a current return path for stimulation current applied by the stimulation electrodes; alternatively, the ground electrode(s) may be provided separate from the electrode lead. The ground electrode may be designed as a ring electrode, which is disposed on the electrode lead and is electrically connected via a ground wire extending within the proximal portion of the electrode lead to the cochlear implant. An example of such cochlear implant system is described in WO 2019/045747 A1.
Another example of a cochlear implant electrode lead with a ground ring electrode is known from U.S. Pat. No. 9,561,361 B1, wherein the ring electrode is provided on a large diameter tube, with the stimulation electrode wires being helically coiled through the interior of the tube which is backfilled with silicone; also the ground wire is helically coiled and passes through the center of the helically coiled stimulation wires. Each side of the ring electrode is provided with silicone tapers for smoothing the profile of the tube, for securing the ring electrode in place and for reducing the potential for kinking of the tube. The ring electrode has the shape of a hollow cylindrical cylinder. The ground wire passes out of an opening in the sidewall of the tube and is electrically connected to the ring electrode disposed over the tube.
The ring of the ground electrode and the ground wire may be susceptible to fluid ingress, especially if the electrode lead has been stressed near the ring or the device fantail; fluid ingress can lead to high electrode impedances over time. Further, silicone tapers at both sides of the ring electrode—due to lack of a consistent boundary of the applied silicone—may be susceptible to variants of silicone application.
Hereinafter, examples of the invention will be illustrated by reference to the attached drawings, wherein:
Described herein are an electrode lead for a cochlear implant system and a method for manufacturing the same.
A feature described herein may provide for an electrode lead for a cochlear implant system, having a ground electrode which is relatively resistant to fluid ingress and which can be manufactured in a relatively consistent and efficient manner. It is a further feature to provide for a method of manufacturing such electrode lead.
In some embodiments, these features are achieved by an electrode lead and a manufacturing method as described herein.
The electrode lead described herein is beneficial in that, by providing the ground ring electrode with a central portion whose outer surface is radially elevated relative to the outer surface of the adjacent first end portion and second end portion of the ground ring electrode, so as to form a step at the boundary between the central portion and the first end portion and the second end portion, respectively, or by providing the end portion of the ground ring electrode with ring-like marker structures, reliability and manufacturability of the electrode lead can be improved. In particular, the step or the marker structure provides for a boundary of the silicone application to the end portions of the ground ring electrode, thereby improving consistency of silicone application for the silicone coating of the end portions of the ground ring electrode and the adjacent outer surface of the tube.
According to one embodiment, the outer diameter of the central portion of the ground electrode may be axially substantially constant over the entire length of the central portion so that the outer surface of the central portion is substantially cylindrical.
According to one embodiment, the outer diameter of the first end portion of the ground electrode may be axially substantially constant over the entire length of the first end portion, and the outer diameter of the second end portion of the ground electrode may be axially substantially constant over the entire length of the second end portion.
According to one embodiment, the first end portion and the second end portion of the ground electrode may have substantially the same outer diameter.
According to one embodiment, the first end portion and second end portion of the ground electrode and the central portion of the ground electrode may all have the same inner diameter.
According to one embodiment, the axial dimension of the first end portion of the ground electrode may be substantially identical to the axial dimension of the second end portion of the ground electrode.
According to one embodiment, the ground electrode may comprise at least one slot for receiving an end portion of the ground wire for attachment of the ground wire to the ground electrode.
According to one embodiment, the at least one slot may be provided on the edge of the first end portion and/or the second end portion of the ground electrode, or the at least one slot may be provided in the central portion of the ground electrode.
According to one embodiment, the first end portion and the second end portion of the ground electrode each may be covered by a silicone coating which extends from the outer surface of the tube to the step at the boundary between the central portion and the respective first end portion or the second end portion of the ground electrode so as to seal to the ground electrode to the tube.
According to one embodiment, the outer surface of each of the silicone coatings may substantially flush with the outer surface of the central portion of the ground electrode.
According to one embodiment, the first end portion and/or the second end portion of the ground electrode may comprise at least one opening for ingress of silicone for anchoring the silicone coating to the respective first or second end portion of the ground electrode.
According to one embodiment, the at least one opening may comprise at least one slot provided on the edge of the first end portion and/or the second end portion, or the at least one opening may comprise at least one hole.
According to one embodiment, the outer surface of the first end portion and/or the second end portion of the ground electrode may be provided with surface structures, such as circumferential ribs or circumferential groves forming a partial thread, for improving adhesion of the silicone coating.
According to one embodiment, the outer surface of the first end portion and/or the second end portion of the ground electrode may be roughened for improving adhesion of the silicone coating.
According to one embodiment, the step at the boundary between the first end portion and the central portion and/or the step at the boundary between the second end portion and the central portion may be provided with recesses in the outer surface of the central portion extending axially into the part of the central portion elevated with regard to the first and second end portion of the ground electrode, and the recesses may be configured to allow ingress of silicone for anchoring the silicone coating of the respective first or second end portion at the step.
According to one embodiment, at least part of the inner surface of the ground electrode may comprise a silicone adhesive layer sandwiched between the outer surface of the tube and the inner surface of the ground electrode.
According to one embodiment, the ground wire may be coated with PPSU.
According to one embodiment, electrode wires for the plurality of stimulation electrodes may extend through the interior volume of the tube in a helically wound configuration, and the ground wire may be co-radially wound with regard to the electrode wires.
According to one embodiment, the tube may comprise a first tube portion and a second tube portion which may be axially aligned to each other and which may axially abut each other, thereby forming a circumferential gap in-between which is filled with silicone and which is surrounded by the ground electrode.
According to one embodiment, the gap may form the opening of the tube through which the ground wire extends to the ground electrode.
According to one embodiment, the interior volume of the tube may be backfilled with a fast-cure silicone adhesive.
According to one embodiment, the outer surface of the central portion may be polished or laser textured.
According to one embodiment, the ground electrode may be made of Pt, Ti, a PtIr alloy or a Ti alloy.
According to one embodiment, the ratio of the outer surface area of the central portion of the ground electrode to the total outer surface area of the ground electrode may be from 0.50 to 0.75.
According to one embodiment of the electrode lead, each of the ring-like marker structures may comprise two parallel rings which may be axially spaced apart. for example, each of the ring-like marker structures may be formed by an engraved or laser treated surface portion.
The manufacturing method described herein is beneficial in that it allows for particularly consistent and efficient manufacturing of the electrode lead. In particular, the dual tube configuration, with a first tube portion and a second tube portion abutting each other within the interior of the ground ring electrode, allows for full assembly of a sub-assembly of the ground ring electrode and the ground wire attached to the ground ring electrode, with the ground wire extending through the gap between the first tube portion and the second tube portion, whereby the need for passing the ground wire through the inner diameter of the tub and pulling it out through an opening cut in the tube wall can be avoided.
According to one embodiment, the ground wire may be wound co-radially with the electrode wires. This improves manufacturability and decreases potential-process failures.
According to one embodiment, the ground wire may be made of Pt and coated with PPSU, whereby the bonding to the ground wire and a silicone backfill of the tube may be improved.
According to one embodiment of the method described herein, the outer surface of the central portion of the ground electrode is radially elevated relative to the outer surface of the first end portion and the outer surface of the second end portion of the ground electrode, so as to form a step at the boundary between the first end portion and the central portion and at the boundary between the second end portion and the central portion, respectively, and the silicone coating is applied to the outer surface of the first and second end portion of the ground electrode in such a manner that the outer surface of each of the silicone coatings is substantially flush with the outer surface of the central portion of the ground electrode.
According to one embodiment of the method described herein, each of the first end portion and the second end portion comprises a ring-like marker structure, and the silicone coating is applied to the outer surface of the first and second end portion of the ground electrode in such a manner that the silicone coating does not extend axially beyond the ring-like marker structures into the central portion.
According to one embodiment of the method described herein, the ground wire is wound co-radially with the electrode wires onto the mandrel.
As used hereinafter, the term “distal” refers to portions or components that are farther away from the cochlear implant (hermitically sealed enclosure) or the surgeon implanting the cochlear implant, and the term “proximal” refers to portions or components that are closer to the cochlear implant or the surgeon implanting the cochlear implant. As used hereinafter, the term “substantially” should be understood as “within ±10%”.
The terms “ground electrode”, “ring electrode” and “ground ring electrode” are used in an interchangeable manner hereinafter to designate a ring-shaped ground electrode.
Electrode lead 110 includes an array of stimulating electrodes 112 (also referred to as intracochlear electrodes) disposed on a distal portion of electrode lead 110 and that are configured to be located within and to stimulate the cochlea after the distal portion of electrode lead 110 is inserted into the cochlea. As shown, electrode lead 110 also includes a ground electrode 120 (also referred to as a ring electrode) disposed on a proximal portion of electrode lead 110 and that is configured provide a current return path for stimulation current generated by stimulation electrodes 112 and to remain external to the cochlea after electrode lead 110 is inserted into the cochlea. While a single ground electrode 120 is shown in
As shown, cochlear implant system 100 may include various components configured to be located external to a patient including, but not limited to, microphone 102, sound processor 104, and headpiece 106. Cochlear implant system 100 may further include various components configured to be implanted within the patient including, but not limited to, cochlear implant 108 and electrode lead 110.
Microphone 102 may be configured to detect audio signals presented to the user. Microphone 102 may be implemented in any suitable manner. For example, microphone 102 may include a microphone that is configured to be placed within the concha of the ear near the entrance to the ear canal, such as a T-MIC™ microphone from Advanced Bionics. Such a microphone may be held within the concha of the ear near the entrance of the ear canal by a boom or stalk that is attached to an ear hook configured to be selectively attached to sound processor 104. Additionally, or alternatively, microphone 102 may be implemented by one or more microphones disposed within headpiece 106, one or more microphones disposed within sound processor 104, one or more beam-forming microphones, and/or any other suitable microphone as may serve a particular implementation.
Sound processor 104 (i.e., one or more components included within sound processor 104) may be configured to direct cochlear implant 108 to generate and apply electrical stimulation (also referred to herein as “stimulation current”) representative of one or more audio signals (e.g., one or more audio signals detected by microphone 102, input by way of an auxiliary audio input port, input by way of a clinician's programming interface (“CPI”) device, etc.) to one or more stimulation sites associated with an auditory pathway (e.g., the auditory nerve) of the patient. Exemplary stimulation sites include, but are not limited to, one or more locations within the cochlea, the cochlear nucleus, the inferior colliculus, and/or any other nuclei in the auditory pathway. To this end, sound processor 104 may process the one or more audio signals in accordance with a selected sound processing strategy or program to generate appropriate stimulation parameters for controlling cochlear implant 108. Sound processor 104 may be housed within any suitable housing (e.g., a behind-the-ear (“BTE”) unit, a body worn device, headpiece 106, and/or any other sound processing unit as may serve a particular implementation).
In some examples, sound processor 104 may wirelessly transmit stimulation parameters (e.g., in the form of data words included in a forward telemetry sequence) and/or power signals to cochlear implant 108 by way of a wireless communication link 114 between headpiece 106 and cochlear implant 108 (e.g., a wireless link between a coil disposed within headpiece 106 and a coil physically coupled to cochlear implant 108). It will be understood that communication link 114 may include a bi-directional communication link and/or one or more dedicated uni-directional communication links.
Headpiece 106 may be communicatively coupled to sound processor 104 and may include an external antenna (e.g., a coil and/or one or more wireless communication components) configured to facilitate selective wireless coupling of sound processor 104 to cochlear implant 108. Headpiece 106 may additionally or alternatively be used to selectively and wirelessly couple any other external device to cochlear implant 108. To this end, headpiece 106 may be configured to be affixed to the patient's head and positioned such that the external antenna housed within headpiece 106 is communicatively coupled to a corresponding implantable antenna (which may also be implemented by a coil and/or one or more wireless communication components) included within or otherwise associated with cochlear implant 108. In this manner, stimulation parameters and/or power signals may be wirelessly transmitted between sound processor 104 and cochlear implant 108 via a communication link 114 (which may include a bi-directional communication link and/or one or more dedicated uni-directional communication links as may serve a particular implementation).
Cochlear implant 108 may include any type of implantable stimulator that may be used in association with the systems and methods described herein. For example, cochlear implant 108 may be implemented by an implantable cochlear stimulator. In some alternative implementations, cochlear implant 108 may include a brainstem implant and/or any other type of cochlear implant that may be implanted within a patient and configured to apply stimulation to one or more stimulation sites located along an auditory pathway of a patient.
In some examples, cochlear implant 108 may be configured to generate electrical stimulation representative of an audio signal processed by sound processor 104 (e.g., an audio signal detected by microphone 102) in accordance with one or more stimulation parameters transmitted thereto by sound processor 104. Cochlear implant 108 may be further configured to apply the electrical stimulation to one or more stimulation sites (e.g., one or more intracochlear regions) within the patient via electrodes 112, 120 disposed along electrode lead 110 (e.g., applying current by way of stimulating electrodes 112 that returns by way of ground electrode 120). In some examples, cochlear implant 108 may include a plurality of independent current sources each associated with a channel defined by one or more of electrodes 112. In this manner, different stimulation current levels may be applied to multiple stimulation sites simultaneously by way of multiple electrodes 112.
The human cochlea is in the shape of a spiral beginning at a base and ending at an apex, and auditory nerve tissue resides within the cochlea resides. The auditory nerve tissue is organized within the cochlea in a tonotopic manner. Relatively low frequencies are encoded at or near the apex of the cochlea (referred to as an “apical region”) while relatively high frequencies are encoded at or near the base (referred to as a “basal region”). Hence, electrical stimulation applied by way of electrodes disposed within the apical region (i.e., “apical electrodes”) may result in the patient perceiving relatively low frequencies and electrical stimulation applied by way of electrodes disposed within the basal region (i.e., “basal electrodes”) may result in the patient perceiving relatively high frequencies. The delineation between the apical and basal electrodes on a particular electrode lead may vary depending on the insertion depth of the electrode lead, the anatomy of the patient's cochlea, and/or any other factor as may serve a particular implementation.
An example of a ring-shaped ground electrode (hereinafter “ring electrode 120”) disposed on the electrode lead 110 is shown in
A helically wound or coiled ground wire 160 extends from the cochlear implant 108 through the interior volume 158 of the second tube portion 154 to the ring electrode 120, to which it is electrically connected, typically via laser welding. As can be seen in
The preferred materials for the coating of the ground wire 160 and the backfill of the tube 150 provide for good fluid resistance and increased adhesion.
As shown in
The ring electrode 120 comprises a first end portion 122, a central portion 124 axially adjacent to the first end portion 122 and a second end portion 126 axially adjacent to the central portion 124. The outer surface 128 of the central portion 124 is radially elevated relative to the outer surface 130 of the first end portion 122 and the outer surface 132 of the second end portion 126, so as to form a step 134 at the boundary between the first end portion 122 and the second end portion 124 and a step 136 at the boundary between the second end portion 126 and the central portion 124, respectively. The outer surface 128 of the central portion 124 may be highly polished for best biofilm resistance or it may be laser textured to increase the surface area.
In the example shown in
The ring electrode 120 may be made of Pt, Ti, a PtIr alloy or a Ti alloy or any other biocompatible conductor.
As can be seen in
As can be seen in
As can be seen in
As illustrated by the examples shown in
In some embodiments, the ring electrode 120 comprises at least one opening for receiving an end portion 162 of the ground wire 120, which is to be welded to the ground electrode 120. For example, as illustrated in
In the examples shown in
Various features for enhancing attachment of the silicone coatings 170 or 172 to the ring electrode 120 are illustrated in
For example, the first end portion 122 and/or the second end portion 126 of the ring electrode 120 may comprise at least one opening for ingress of silicone during manufacturing for anchoring the silicone coating 170, 172 to the respective first or second end portion 122, 126. For example, as shown in
In other examples, the outer surface 130, 132 of the first and second end portions 122, 126 are provided with surface structures for improving the adhesion of the silicone coating 170, 172. For example, as shown in
Alternatively, or in addition, the outer surfaces 130, 132 of the first and second end portions 122, 126 may be roughened for improving adhesion of the silicone coating 170, 172, such as by bead blast treatment, laser treatment or chemical etch; this is schematically illustrated by the darker color in
In some examples, the step 134, 136 between the first and second end portion 122, 126 and the central portion 124, respectively, may be provided with recesses 198, which are circumferentially spaced apart and which are provided in the outer surface 128 of the central portion 124 and extend axially into the elevated part of the central portion 124. The recesses 198 are configured to allow ingress of silicone during manufacturing for anchoring the silicone coatings 170, 172 in the respective first or second end portion 122, 126 at the steps 134, 136 (see
An example of a method for manufacturing the electrode lead 100 illustrated in
In a first step illustrated in
In the example of
In the step shown in
In a next step, a plurality of parallel stimulation electrode wires 176 is helically wound/coiled onto a mandrel 200. As illustrated in
In a next step, as illustrated in
In the step illustrated in
In some implementations the ratio of the outer surface area of the central portion 124 to the total outer surface area of the ring electrode 120 (formed by the sum of the outer surfaces of the central portion 124 and the first and second end portions 122, 126) is from 0.50 to 0.75. The outer surface of the central portion 124 represents the exposed surface of the ring electrode 120.
In
While in the above examples of the ring electrode 120 the central portion 124 is elevated so as to ensure proper placement of the silicone coating on the ring electrode 120 by providing a boundary of the silicone application to the end portions of the ring electrode, in an alternative embodiment such boundary may be provided by a ring-like marker structure on each of the end portions of the ring electrode. Such ring-like marker structures serve to mark the axial boundary of the proper silicone application, so as to ensure that the operator applies a silicone coating to the outer surface of the first and second end portion of the ground electrode in such a manner that the silicone coating does not extend axially beyond the respective marker structure into the central portion.
An example of such ring electrode 220 is shown in
| Number | Date | Country | Kind |
|---|---|---|---|
| EP21165630 | Mar 2021 | EP | regional |
