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公开(公告)号：US06473651B1
公开(公告)日：2002-10-29
申请号：US09514100
申请日：2000-02-28
IPC分类号： H04R2500
CPC分类号： H04R25/606
摘要： An implantable microphone system, usable with a cochlear implant system or other hearing aid prosthesis, detects sound pressure waves (acoustic waves) at a movable member within the middle ear, e.g., the tympanic membrane or the stapes, through a fluid communication channel (20) established between the middle ear movable member and a microphone capsule (10). The microphone capsule (10) includes two compartments (11, 12) separated by a flexible diaphragm (13). One compartment (12) is in fluid communication with a thin-walled balloon, filled with a suitable fluid (30), positioned in contact with the movable member within the middle ear. The other compartment (11) is mechanically coupled through a suitable mechanical linkage (16) to a microphone sensor (14). The microphone sensor, in turn, is electrically connected to the cochlear implant system or other hearing aid prosthesis.
摘要翻译： 可植入麦克风系统，可与耳蜗植入物系统或其他助听器假体一起使用，通过流体连通通道（20）检测中耳内的可移动构件（例如鼓膜或镫骨）上的声压波（声波） ）建立在中耳可移动部件和麦克风胶囊（10）之间。 麦克风胶囊（10）包括由柔性隔膜（13）分开的两个隔间（11,12）。 一个隔室（12）与薄壁气囊流体连通，填充有适当的流体（30），定位成与中耳内的活动件接触。 另一个隔间（11）通过合适的机械联动装置（16）机械耦合到麦克风传感器（14）。 麦克风传感器又电连接到耳蜗植入系统或其他助听器假体。
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公开(公告)号：US06754537B1
公开(公告)日：2004-06-22
申请号：US09979804
申请日：2001-11-13
IPC分类号： A61N118
CPC分类号： A61N1/36036 , A61N1/0541
摘要： A hybrid cochlear implant hearing aid sytem (10) provides low frequency acoustic energy boost, if needed, and high frequency direct neural stimulation. Tinnitus suppression may also be provided. The neurons responsible for sensing high frequency sounds are located at the basal end of the cochlea. A short basal electrode (52) that extends into the cochlea only at the basal region allows direct stimulation of these neurons by an appropriately-controlled cochlear stimulator (50). The basal electrode array typically has from four to eight electrode contacts (54). The design of the electrode array allows the surgeon to place the array using minimally invasive surgical techniques and requires no cochleostomy. The electrode array is thin, and can typically be inserted directly through the round window membrane to make contact with, or to be positioned in close proximity to, the modiolus wall in the basal region of the cochlea. The hybrid implantable cochlear stimulator and hearing aid system relies primarily on the cochlear stimulator portion of the system for being able to sense high frequency sounds, and relies primarily on normal hearing processes, or other acoustic boosting devices and systems, for being able to sense lower frequency sounds.
摘要翻译： 混合耳蜗植入式助听器系统（10）提供低频声能增强，如果需要，以及高频直接神经刺激。 也可以提供耳鸣抑制。 负责感测高频声音的神经元位于耳蜗的基端。 仅在基底区域延伸到耳蜗的短基底电极（52）允许通过适当控制的耳蜗刺激器（50）直接刺激这些神经元。 基极电极阵列通常具有四至八个电极触点（54）。 电极阵列的设计允许外科医生使用微创手术技术来放置阵列，并且不需要耳蜗造口术。 电极阵列是薄的，并且通常可以直接插入通过圆窗膜以与耳蜗的基底区域中的闭孔壁接触或靠近位置。 混合植入式耳蜗刺激器和助听器系统主要依赖于系统的人工耳蜗刺激器部分，以便能够感测高频声音，并且主要依赖于正常听力过程或其他声学增强装置和系统，以便能够感测较低频 频率声音。
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公开(公告)号：US06889094B1
公开(公告)日：2005-05-03
申请号：US09979800
申请日：2000-05-12
IPC分类号： A61N1/05
CPC分类号： A61N1/0541
摘要： A cochlear electrode array is adapted for implantation within the basal end of the scala tympani duct of a human cochlea. A first embodiment of the cochlear electrode array (10) comprises a skinny, elongate carrier (12) of from 6-8 mm in length. Four to eight spaced-apart electrode contacts (14) reside along one of the flat sides of the carrier, each of which is connected to a respective wire (22) embedded within the carrier. The wires exit a proximal end of the carrier via a wire bundle. The wire bundle, in turn, is connectable to an implantable cochlear stimulator (ICS) or equivalent pulse generator. The electrode array (10) is inserted into the relatively straight portion of the basal end of the scala tympani duct of the cochlea through a small slit (42) made in the round window membrane that separates the cochlea from the middle ear. The slit is oriented so as to place the electrode contacts facing the modiolar wall (32). The proximal end of the carrier may include flexible flaps (16) or tines that maintain the electrode array in its desired position within the basal end of the cochlea. Such tines or flaps further help seal the carrier against the slit opening to present fluids from escaping the cochlea. The cochlea thus remains filled with fluid which can activate hair cells as fluid waves are established through motion of the round window membrane. In use, electrical stimulation is provided only to the basal end of the cochlea through the electrode array to supplement hearing of high frequency sounds. Normal hearing (activation of hair cells through fluid motion) occurs at the apex and middle regions of the cochlea for sensing lower frequency sounds. A second embodiment of the cochlear electrode (100) is made by forming a small (120) of about 0.4 mm diameter on the end of a very fine flexible platinum/iridium (Pt/Ir) wire (140). At a proximal end of the wire, a suitable connector (540) allows the wire to be detachably connected to a pulse generator (500).
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公开(公告)号：US06757970B1
公开(公告)日：2004-07-06
申请号：US10000408
申请日：2001-11-02
IPC分类号： H05K302
CPC分类号： A61N1/0529 , A61N1/0551 , Y10T29/49117 , Y10T29/49155 , Y10T29/49156
摘要： A multicontact electrode array suitable for implantation in living tissue includes a distal end having multiple spaced-apart ring contacts or a pattern of spaced-apart electrode contacts carried on a flexible carrier. Each electrode contact is resistance welded to a respective wire that is wound helically inside a silicon tube. The center of the helix defines a lumen wherein a positioning stylet, or other suitable positioning tool, may be removably inserted when the electrode array is implanted. The electrode array is made using a method that includes, as an initial step, winding lead wires around a suitable mandrel forming a helix configuration. Next, a non-conductive silicone tube jacket is placed around the wound wires, exposing the distal lead ends of the wires at a distal end of the tube. A welding process is then used to bond each wire tip to a corresponding metal electrode contact which has been preassembled by resistance welding to a metal foil structural carrier. The electrode array, including the metal foil structural carrier, is then formed into a tube by drawing it through a die. The excess foil material at the distal tip is then trimmed and a heat-shrink tube is placed around the assembled foil tube to prevent leakage of the polymer filler material through the joining longitudinal line of the carrier. Next, the foil tube is injected with a polymer filler material to void any gaps between the lead wires and contacts. To avoid filling the central lumen with the polymer filler material, a central core or stylet is temporarily placed inside the lumen. The heat-shrink tube is then mechanically removed. The fabrication method is finalized by inserting the preassembled electrode array into a hot acid mixture, which etches away the metal foil carrier, exposing the contacts at the surface of a distal end of the electrode array.
摘要翻译： 适于植入生物组织的多电极电极阵列包括具有多个间隔开的环形触点的远端或承载在柔性载体上的间隔开的电极触点的图案。 每个电极接触件被电阻焊接到螺旋形地缠绕在硅管内的相应导线。 螺旋的中心限定了内腔，其中当植入电极阵列时可以可移除地插入定位探针或其它合适的定位工具。 电极阵列使用包括作为初始步骤的方法包围围绕形成螺旋结构的适当心轴的引线。 接下来，将不导电的硅胶管夹套放置在缠绕的线周围，将导线的远端引线末端暴露在管的远端。 然后使用焊接工艺将每个焊丝尖端粘合到已经通过电阻焊接预先组装到金属箔结构载体上的对应的金属电极接触。 包括金属箔结构载体的电极阵列然后通过将其拉伸通过模头而形成管。 然后修剪远侧末端处的多余的箔材料，并且将热收缩管放置在组装的箔管周围，以防止聚合物填充材料通过载体的接合纵向线泄漏。 接下来，箔管注入聚合物填充材料以去除引线和触点之间的任何间隙。 为了避免用聚合物填充材料填充中央内腔，中心芯或探针被临时放置在管腔内。 然后机械地去除热收缩管。 通过将预组装的电极阵列插入热酸混合物来完成制造方法，所述热酸混合物蚀刻掉金属箔载体，暴露电极阵列远端表面处的触点。
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5.发明授权Implantable cochlear stimulator system incorporating combination electrode/transducer 失效包含组合电极/换能器的植入式耳蜗刺激器系统公开(公告)号：US06259951B1
公开(公告)日：2001-07-10
申请号：US09569696
申请日：2000-05-12
IPC分类号： A61N100
CPC分类号： A61N1/0541 , A61N1/36036 , H04R2225/67
摘要： A hearing aid system provides acoustic modulation of the fluid within the cochlea of the inner ear corresponding to a first frequency range of sensed acoustic signals, e.g., lower-to-middle frequencies of the audible range, and electrical stimulation of the cochlea corresponding to a second frequency range, e.g., high frequencies of the audible range. In a preferred implementation, a short electrode/transducer array is provided for use with the hearing system. Such array is adapted to be inserted into the basal region of the scala tympani of the cochlea. The electrode/transducer array includes a plurality of spaced-apart electrode contacts through which electrical stimulation is provided to stimulate ganglion cells located in the basal region of the cochlea, which cells are responsible for perceiving the higher frequencies of the acoustic energy. The electrode/transducer further includes an acoustic modulator as an integral part thereof, in fluid communication with an acoustic transducer, through which acoustic modulation may be coupled to the fluid within the cochlea, thereby allowing normal hearing processes to occur in the cochlea. In the preferred implementation, the lower frequencies of sensed acoustic energy are processed to provide modulation of the acoustic modulator. An implantable cochlear stimulator (ICS), including the acoustic transducer and coil, and implantable speech processor (ISP), including an implantable microphone, are used with the system. In an alternative embodiment, the acoustic modulator within the electrode/transducer array is used as a sensor, to sense fluid modulation within the cochlea resulting from a functioning middle ear, and the acoustic transducer converts such sensed fluid modulation to electrical signals, thereby providing the function of an microphone implanted in the cochlea.
摘要翻译： 助听器系统提供对应于感测的声信号的第一频率范围（例如可听范围的下到中频）的耳内耳内的流体的声调，以及对应于耳蜗的耳蜗的电刺激 第二频率范围，例如可听范围的高频。 在优选的实施方式中，提供了一种与听力系统一起使用的短电极/换能器阵列。 这种阵列适于插入耳蜗鼓膜的基底区域。 电极/换能器阵列包括多个间隔开的电极触点，通过电极触点提供电刺激以刺激位于耳蜗的基底区域中的神经节细胞，该细胞负责感知声能的较高频率。 电极/换能器还包括声学调制器作为其整体部分，与声换能器流体连通，通过声学调节器，声调制可耦合到耳蜗内的流体，从而允许在耳蜗中发生正常的听觉过程。 在优选实施例中，处理感测声能的较低频率以提供声调制器的调制。 该系统使用包括声学换能器和线圈的植入式耳蜗刺激器（ICS）和可植入语音处理器（ISP），包括可植入麦克风。 在替代实施例中，电极/换能器阵列内的声调制器用作传感器，以感测由功能中耳产生的耳蜗内的流体调节，并且声换能器将这种感测到的流体调制器转换为电信号，由此提供 植入耳蜗的麦克风的功能。
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6.发明授权Cochlear electrode array having current-focusing and tissue-treating features 有权具有电流聚焦和组织处理特征的耳蜗电极阵列公开(公告)号：US06304787B1
公开(公告)日：2001-10-16
申请号：US09375424
申请日：1999-08-17
IPC分类号： A61N136
CPC分类号： A61N1/0541
摘要： An implantable electrode array, adapted for insertion into a cochlea, provides a multiplicity of exposed electrode contacts, each having a shape, geometry, or makeup that aids in controlling the current flow and current density associated with the electrode contact as a function of position on the electrode contact. In one embodiment, the shape or geometry of the exposed electrode contact controls the contact surface of the electrode contact in a way that varies the current flow and current density as a function of surface area position on the electrode, thereby focusing most of the current to flow through the center of the electrode contact. In another embodiment, the electrode contact is coated with a dielectric or other material that controls the surface contact impedance as a function of distance from the center of the electrode, again focusing most of the current flow through the center of the electrode contact. In yet a further embodiment, the exposed electrode contact surface area is masked with an insulator to prevent conduction of current at various locations on the surface of the electrode contact. Separately, or in combination with any of the above embodiments, the exposed electrode contact surface and/or the entire electrode array may be coated with a selected substance or drug compound that diffuses into the tissue and liquids surrounding the electrode. Such substance or drug compound is selected to elicit a desired result, e.g., to inhibit fibrous tissue or bone growth in the vicinity of the electrode contacts; to promote healing of damaged tissue in the region of the electrode contacts, to prevent neural degeneration, or to promote neural regeneration.
摘要翻译： 适于插入耳蜗的可植入电极阵列提供多个暴露的电极触点，其各自具有形状，几何形状或组合，其有助于控制与电极接触相关联的电流流动和电流密度作为位置的函数 电极接触。 在一个实施例中，暴露的电极接触件的形状或几何形状以电极流动和电流密度作为电极上的表面积位置的函数来控制电极接触件的接触表面，从而将大部分电流聚焦到 流过电极接触点的中心。 在另一个实施例中，电极接触件涂覆有电介质或其它材料，其控制作为距电极中心的距离的函数的表面接触阻抗，再次将电流大部分流经电极接触的中心。 在又一个实施例中，暴露的电极接触表面区域被绝缘体掩蔽，以防止在电极接触表面上的各个位置的电流传导。 单独地或与任何上述实施例组合，暴露的电极接触表面和/或整个电极阵列可以涂覆有扩散到组织中的选定物质或药物化合物和电极周围的液体。 选择这样的物质或药物化合物以引出期望的结果，例如抑制电极接触附近的纤维组织或骨生长; 促进电极接触区域受损组织的愈合，防止神经变性，或促进神经再生。
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公开(公告)号：US06266568B1
公开(公告)日：2001-07-24
申请号：US09300800
申请日：1999-04-27
IPC分类号： A61N104
CPC分类号： A61N1/0541
摘要： 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.
摘要翻译： 适于插入到人类耳蜗中的充气耳蜗电极阵列包括柔性载体，其上承载有多个间隔开的电极触点，优选地沿载体的一侧，例如内侧。 柔性载体还包括可充气的隔室或部分。 在一个实施例中，可充气部分位于与电极接触件相对的柔性载体侧上的电极阵列的远端。 在另一个实施例中，可充气隔室或部分沿柔性载体的全长的至少一半定位，形成脊柱。 在任一实施例中，电极容易地插入耳蜗到期望的深度，同时可充气隔间或部分保持在放气状态。 此后，通过在其中注射合适的生物相容性流体来使充气室或部分膨胀来实现所需的夹层位置。 还公开了制造充气耳蜗电极的方法。
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8.发明授权Method of making a cochlear electrode array having current-focusing and tissue-treating features 有权制造具有电流聚焦和组织处理特征的耳蜗电极阵列的方法公开(公告)号：US06862805B1
公开(公告)日：2005-03-08
申请号：US09945304
申请日：2001-08-31
CPC分类号： A61N1/0541 , Y10T29/49117 , Y10T29/49156 , Y10T29/49169 , Y10T29/49174 , Y10T29/49176 , Y10T29/49179
摘要： A method of making an implantable electrode array, adapted for insertion into a cochlea, includes the steps of: (a) forming electrode contact pieces made from a precious, biocompatible material into a desired shape; (b) attaching the electrode contact pieces to a foil sheet made from a non-toxic but chemically-active metal; (c) connecting a wiring system to the metal contact pieces; (d) molding a flexible polymer carrier around the electrode contact pieces and wiring system while such are held in place by the foil sheet; and (e) etching away the foil sheet, leaving the electrode contact pieces exposed at a surface of the molded polymer carrier. The exposed electrode contacts are made so as to have a shape, geometry, or makeup that aids in controlling the current flow and current density associated with the electrode contact as a function of position on the electrode contact.
摘要翻译： 制造适于插入耳蜗的可植入电极阵列的方法包括以下步骤：（a）将由珍贵的生物相容性材料制成的电极接触片形成为期望的形状; （b）将电极接触片连接到由无毒但化学活性金属制成的箔片上; （c）将布线系统连接到金属接触片上; （d）在电极接触片和布线系统周围形成柔性聚合物载体，同时通过箔片保持在适当位置; 和（e）蚀刻掉箔片，留下电极接触片露出在模制聚合物载体的表面。 暴露的电极触点被制成为具有形状，几何形状或组合，其有助于控制与电极接触相关联的电流和电流密度作为电极接触件上的位置的函数。
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公开(公告)号：US06208882B1
公开(公告)日：2001-03-27
申请号：US09323594
申请日：1999-06-01
IPC分类号： A61B504
CPC分类号： A61N1/0541 , A61F2002/183
摘要： A stapedius electrode attaches to or is embedded within the stapedius muscle (20) at a point near where the stapedius muscle is visible as it exits a bony channel (30) within the middle ear. In one embodiment, the electrode is made from a biocompatible metal wire formed into a flat blade (102) having a sharp tip (104) and serrations (103) 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 (84) of a multistrand insulated wire (82) that is embedded in the stapedius muscle tissue (20) using a delivery needle (86). A tube connector (90) may be used to electrically connect a lead coming form the implanted stapedius electrode to an implant device. The tube connector (90) includes a platinum tube (92) welded at one end to a lead (91) coming from the implant device. A proximal end (83) of the lead from the electrode is crimped to the other end of the tube (92). A silicone tube or sleeve (94) is then placed over the tube and sealed at both ends.
摘要翻译： 吻合器电极附近或嵌入在钉胸肌（20）内的位置，该缝合肌在远离中耳内的骨通道（30）处可见的位置附近。 在一个实施例中，电极由生物相容的金属线制成，该金属线形成为沿着一个边缘具有尖锐尖端（104）和锯齿（103）的平坦刀片（102）。 绝缘引线电连接和机械连接到刀片。 可以通过在电极的一端围绕电极的主体焊接和包裹绝缘引线来保护这种焊接并且用涂层或环氧树脂块来固定这样的包装来进行这种连接。 在植入电极期间，电极刀片插入通过在肌肉组织中制成的小槽。 或者，当电极通过骨通道时，可以通过骨壁中的开口沿着肌肉组织插入，电极的尖端从骨通道突出。 然后将突出的尖端弯曲以覆盖骨壁，并将电极保持在适当位置。 还提出了钉扎电极的其它实施例。 例如使用输送针（86）嵌入在钉胸肌组织（20）中的多股绝缘电线（82）的远端（84）。 管连接器（90）可以用于将从植入的钉持器电极形成的引线电连接到植入装置。 管连接器（90）包括在一端焊接到来自植入装置的引线（91）的铂管（92）。 来自电极的引线的近端（83）被压接到管（92）的另一端。 然后将硅胶管或套管（94）放置在管上并在两端密封。
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10.发明授权公开(公告)号：US07050858B1
公开(公告)日：2006-05-23
申请号：US10116464
申请日：2002-04-03
IPC分类号： A61N1/00
CPC分类号： A61N1/0541 , A61B17/3403 , A61B17/3468 , A61B2017/00787
摘要： An insertion tool uses a stylet wire to help guide an electrode system into a cochlea. The insertion tool includes three main elements or parts: a handle, a guide and a slider. The handle is made from light stainless steel tube flattened in front with a machined slot. The guide consists of a plurality of metal tubes, fixed to each other within a holding bracket. In one embodiment, the slider includes a stabilizer wire, a long stylet wire, and a short stylet wire. During the assembly process, the stabilizer and stylet wires are inserted into respective tubes of the guide and the end of the stabilizer wire is bent to form an offset. The electrode system is loaded onto the tool by inserting the short stylet wire into a holder that supports the electrode lead.
摘要翻译： 插入工具使用探针线来帮助引导电极系统进入耳蜗。 插入工具包括三个主要元件或部件：手柄，引导件和滑块。 手柄由轻质不锈钢管制成，前面带有加工槽。 引导件由多个金属管组成，其在固定支架内相互固定。 在一个实施例中，滑块包括稳定线，长针刺线和短探针线。 在组装过程中，将稳定器和探针线插入到引导件的相应管中，并且稳定线的端部弯曲以形成偏移。 通过将短的针刺线插入支撑电极引线的支架中，将电极系统装载到工具上。
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