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21. 发明授权

US07805202B2 Implantable electrodes and insertion methods and tools 有权
标题翻译：可植入电极和插入方法和工具
公开(公告)号：US07805202B2
公开(公告)日：2010-09-28
申请号：US11241158
申请日：2005-09-30
申请人： Janusz A. Kuzma , Todd Kevin Whitehurst , Lani A. Smith , Chuladatta Thenuwara
发明人： Janusz A. Kuzma , Todd Kevin Whitehurst , Lani A. Smith , Chuladatta Thenuwara
IPC分类号： A61N1/02
CPC分类号： A61N1/0551 , A61N1/0529 , A61N1/0553
摘要： An insertion kit for implanting an electrode in a patient can include a handle; an insertion member coupled to the handle at a proximal end of the insertion member and configured and arranged to be inserted into a patient; an alignment member coupled to the handle and disposed over the distal end of the insertion member; and an electrode configured and arranged to be inserted into the patient using the insertion member. In some instances, the insertion kit may also include one or more of a marker that cooperates with the alignment member to mark a position of the electrode on the skin of the patient; a pointer that cooperates with the alignment member to find the marked position on the skin of the patient; and a second electrode and a second insertion member configured and arranged for detachably coupling to the handle in place of the insertion member.
摘要翻译：用于将电极植入患者体内的插入套件可以包括手柄; 插入构件，其在所述插入构件的近端处联接到所述手柄并且被配置和布置成插入到患者体内; 对准构件，其联接到所述手柄并设置在所述插入构件的远端上方; 以及电极，其构造和布置成使用插入构件插入到患者体内。在一些情况下，插入套件还可以包括与对准构件配合以标记电极在患者皮肤上的位置的标记物中的一个或多个; 与对准构件协作以在患者皮肤上找到标记位置的指针; 以及第二电极和第二插入构件，其构造和布置成可替代所述插入构件可拆卸地联接到所述手柄。

22. 发明授权

US07315763B2 Cochlear implant electrode and method of making same 有权
标题翻译：人工耳蜗植入电极及其制作方法
公开(公告)号：US07315763B2
公开(公告)日：2008-01-01
申请号：US10666465
申请日：2003-09-19
申请人： Janusz A. Kuzma , Lani A. Smith , Chuladatta Thenawara , Steven A. Hazard
发明人： Janusz A. Kuzma , Lani A. Smith , Chuladatta Thenawara , Steven A. Hazard
IPC分类号： A61N1/05
CPC分类号： A61N1/0541 , A61N1/36036
摘要： A cochlear stimulation lead having a pre-curved electrode array is provided. The molding process provides memory to the curved part of the lead. The lead may be made having a stylet insertion channel that extends from a slightly curved or substantially straight section and into the highly curved section of the lead. Because high compliance is desired for the lead in cochlear stimulation applications, the compliance is controlled not only by the taper at the distal end of the lead and overall lead thickness, but also by choosing the material hardness of the lead carrier/covering and employing compliant zigzagged conductor wire. In addition, differential lead compliance/stiffness can be achieved by using a stiff tubing that forms part of the stylet insertion channel.
摘要翻译：提供具有预弯曲电极阵列的耳蜗刺激引线。模制过程为铅的弯曲部分提供记忆。引线可以制成具有从略微弯曲或基本上直的部分延伸到引线的高度弯曲部分的探针插入通道。由于耳蜗刺激应用中的铅需要高度依从性，所以顺应性不仅受铅的远端的锥度和整体铅厚度的控制，而且还通过选择引线载体/覆盖物的材料硬度并采用顺应性曲折导线。此外，通过使用形成探针插入通道的一部分的硬管可以实现差动引线顺从/刚度。

23. 发明授权

US07054691B1 Partitioned implantable system 有权
标题翻译：分区植入系统
公开(公告)号：US07054691B1
公开(公告)日：2006-05-30
申请号：US10346482
申请日：2003-01-17
申请人： Janusz A. Kuzma , Michael A. Faltys
发明人： Janusz A. Kuzma , Michael A. Faltys
IPC分类号： A61N1/00
CPC分类号： H04R25/606 , H04R2225/67 , H04R2410/00
摘要： An implantable system includes a plurality of implantable devices that are detachably coupled to each other. Each implantable device of the system includes: (1) an hermetically-sealed case housing electronic components; (2) feedthru terminals mounted to a wall of the hermetically-sealed case adapted to allow electrical contact from a location outside the hermetically-sealed case with the electronic components housed inside the hermetically-sealed case; (3) a coil external to the hermetically-sealed case attached to the feedthru terminals; (4) a flexible molding bonded to the hermetically-sealed case, and wherein the coil is embedded within or otherwise attached to the flexible molding; and (5) engagement means for engaging the flexible molding with a flexible molding of another implantable device of the implantable system. Such engagement means also aligns the coils of the implantable devices that are thus engaged with the engaging means to allow electromagnetic coupling to occur between the aligned coils. In one embodiment, the engaging means includes a hole formed in the flexible molding of a first implantable device and a knob portion formed in the flexible molding of a second implantable device, wherein the knob portion is sized to fit within the hole, and wherein when the knob portion is placed within the hole, the coil of the first device is coaxially aligned with the coil of the second implantable device.
摘要翻译：可植入系统包括可拆卸地彼此联接的多个可植入装置。系统的每个可植入装置包括：（1）密封的电子元件壳体; （2）安装在密封壳体的壁上的馈通端子，其适于允许从密封的壳体外部的位置与容纳在密封的壳体内的电子部件电接触; （3）安装在馈通端子上的气密密封外壳外部的线圈; （4）柔性模制件，其结合到所述密封的壳体上，并且其中所述线圈嵌入所述柔性模制件中或以其他方式附接到所述柔性模制件; 和（5）接合装置，用于将柔性模制件与可植入系统的另一可植入装置的柔性模制件接合。这种接合装置还使由此与接合装置接合的可植入装置的线圈对齐，以允许在排列的线圈之间发生电磁耦合。在一个实施例中，接合装置包括形成在第一可植入装置的柔性模制件中的孔和形成在第二可植入装置的柔性模制件中的把手部分，其中按钮部分的尺寸适于装配在孔内，旋钮部分放置在孔内，第一装置的线圈与第二可植入装置的线圈同轴对准。

24. 发明授权

US06879695B2 Personal sound link module 失效
标题翻译：个人声音链接模块
公开(公告)号：US06879695B2
公开(公告)日：2005-04-12
申请号：US10264937
申请日：2002-10-03
申请人： Albert A. Maltan , Janusz A. Kuzma
发明人： Albert A. Maltan , Janusz A. Kuzma
IPC分类号： H04R25/00
CPC分类号： H04R25/606
摘要： A personal sound link module (60) is inserted into a tunnel (40) made through the soft tissue connecting the retro-auricular space (50) with the ear canal (30). The module contains an acoustic transducer (65), located at the distal part (68) of the module, close to or inside the ear canal, an antenna (64) that receives and also potentially sends signals to a remote source, signal processing circuitry (67), telemetry circuitry (69), a power source (66) that powers the module, and possibly a microphone (63). Signals transmitted from a remote source are received through the antenna and telemetry circuitry, processed, and presented to the acoustic transducer, where they are converted to sound waves broadcast into the user's ear canal. The remote source may be a radio station, radio receiver, CD player, DVD player, tape player, audio system, telephone, TV receiver or station, or other source of audio signals intended to be heard privately by the user.
摘要翻译：将个人声音连接模块（60）插入到通过将耳环空间（50）与耳道（30）连接的软组织制成的隧道（40）中。该模块包含位于模块的远端部分（68）处的声换能器（65），靠近耳道内或耳道内，接收并且还潜在地向远程源发送信号的天线（64），信号处理电路（67），遥测电路（69），为模块供电的电源（66）以及可能的麦克风（63）。从远程源发送的信号通过天线和遥测电路被接收，被处理并呈现给声换能器，在那里它们被转换成广播到用户耳道的声波。远程源可以是用户私下听到的无线电台，无线电接收机，CD播放器，DVD播放器，磁带机，音频系统，电话机，电视接收机或电台，或者其它的音频信号源。

25. 发明授权

US06487453B1 Electrode system for ossified cochlea 失效
标题翻译：用于骨化耳蜗的电极系统
公开(公告)号：US06487453B1
公开(公告)日：2002-11-26
申请号：US09585848
申请日：2000-06-01
申请人： Janusz A. Kuzma , Thomas H. R. Lenarz , Rolf-Dieter Battmer
发明人： Janusz A. Kuzma , Thomas H. R. Lenarz , Rolf-Dieter Battmer
IPC分类号： A61N105
CPC分类号： A61N1/0541
摘要： 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.
摘要翻译：提供电极系统用于插入骨化的耳蜗。电极系统包括第一电极阵列和第二电极阵列，它们都电连接到合适的植入式耳蜗刺激器（ICS）。两个电极阵列中的每一个在其一侧或表面上具有多个间隔开的电极触点，例如第一电极阵列上的八至十二个电极触点，以及第二电极阵列上六至十个电极触点。通过耳蜗的骨化部分钻出隧道，第一电极阵列紧密插入该耳蜗部分。第二电极阵列在其第二匝附近插入耳蜗。在耳蜗完全骨化的情况下，在第二回合处，通过骨化部分钻出第二隧道。定位器可以与第二电极阵列一起使用，以将其电极接触定位在耳蜗的模块壁上。第一和第二电极可以插入耳蜗的鼓膜和/或耳蜗前庭中。

26. 发明授权

US06473651B1 Fluid filled microphone balloon to be implanted in the middle ear 失效
标题翻译：流体填充的麦克风气球植入中耳
公开(公告)号：US06473651B1
公开(公告)日：2002-10-29
申请号：US09514100
申请日：2000-02-28
申请人： Janusz A. Kuzma , Thomas J. Balkany , William Vanbrooks Harrison
发明人： Janusz A. Kuzma , Thomas J. Balkany , William Vanbrooks Harrison
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。

27. 发明授权

US06321126B1 Implantable connector 失效
公开(公告)号：US06321126B1
公开(公告)日：2001-11-20
申请号：US09455046
申请日：1999-12-06
申请人： Janusz A. Kuzma
发明人： Janusz A. Kuzma
IPC分类号： A61N1375
CPC分类号： A61N1/3752 , Y10S439/909
摘要： An implantable connector electrically connects a multi-conductor lead (22) with a small-dimensioned implantable housing (102) of an implantable medical device, such as a cochlear stimulator. The implantable housing has electronic circuitry hermetically sealed therein. The implantable connector includes a header (10) formed along an edge of the implantable housing. The header has a cavity (11) formed therein with a first array of electrical contacts (12) embedded within a bottom surface of the cavity. The electrical contacts are electrically connected with the electronic circuitry through hermetic feedthrough terminals. The header further has a niche (15) and a channel (14) formed therein. A connector pad (20) is dimensioned to fit snugly within the cavity. A bottom surface of the connector pad has a second array of electrical contacts (21) formed therein. The second array of electrical contacts aligns with the first array of electrical contacts in the cavity when the pad is placed inside of the cavity. Electrical contact is established between the electrical contacts of the second array of electrical contacts and the electrical contacts of the first array when the connector pad is placed inside of the cavity. Each conductor within the multi-conductor lead (22) is electrically connected to at least one of the electrical contacts of the second array of electrical contacts. The lead (22) exits from the connector pad along one edge thereof so as to pass through the channel (14) formed within the header. A compressive spring (30) has a first end (33) secured within the niche (15) of the header (10), and has a second end locked to the header at the end of the header opposite the niche. The compressive spring (30) asserts a compressive force against the top surface of the connector pad as the connector pad is fitted within the cavity, thereby maintaining a secure electrical connection between the electrical contacts of the first and second arrays.

28. 发明授权

US06208882B1 Stapedius reflex electrode and connector 有权
标题翻译： Stapedius反射电极和连接器
公开(公告)号：US06208882B1
公开(公告)日：2001-03-27
申请号：US09323594
申请日：1999-06-01
申请人： Thomas H. R. Lenarz , Thomas J. Balkany , Janusz A. Kuzma
发明人： Thomas H. R. Lenarz , Thomas J. Balkany , Janusz A. Kuzma
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。

29. 发明授权

US6144883A Method of making a cochlear electrode array with electrode contacts on medial side 有权
标题翻译：制造具有内侧电极触点的耳蜗电极阵列的方法
公开(公告)号：US6144883A
公开(公告)日：2000-11-07
申请号：US346879
申请日：1999-07-02
申请人： Janusz A. Kuzma
发明人： Janusz A. Kuzma
IPC分类号： A61N1/05
CPC分类号： A61N1/0541 , Y10T29/49117 , Y10T29/49179
摘要： A method of making an implantable electrode array, adapted for insertion into a cochlea, provides stability relative to the electrode contact direction. In-line electrodes are spaced-apart along one side of a flexible carrier. The structure of the electrode array facilitates bending of the array with the electrode contacts on the inside of the bend, yet deters flexing or twisting of the array in other directions. The electrode contacts preferably are each made from two strips of metal, arranged in a "T" shape (top view). During assembly, all of the "T" strips are held in position on an iron sheet. Two wire bundles are formed that pass along each side of each "T". The leg of each "T" is folded over to pinch at least one of the wires from one of the wire bundles therebetween. This pinched wire is then resistance welded to the strip. The sides of the "T" are then folded up and touch or nearly touch to form a ".DELTA." shape (side view). The wire bundles going to more distal electrodes pass through the ".DELTA." and are thus engaged by the ".DELTA.". A flexible carrier, made from, e.g., silicone rubber, is molded over and around the wire bundles and folded electrode T's, preferably in a slightly curved shape, The iron sheet is chemically etched away, leaving an array of spaced-apart electrode contact areas along one edge of the flexible carrier, each of which is electrically attached to at least one wire which passes through the carrier. The electrode array may be manufactured using low cost technology.
摘要翻译：制造适于插入耳蜗的可植入电极阵列的方法提供了相对于电极接触方向的稳定性。在线电极沿着柔性载体的一侧间隔开。电极阵列的结构有利于电极触点在弯曲部内侧的阵列的弯曲，而且阻止阵列在其它方向的弯曲或扭转。电极接触件优选地由两条以“T”形（顶视图）排列的金属条制成。在组装期间，所有的“T”条都保持在铁板上的适当位置。形成通过每个“T”的每一侧的两个线束。每个“T”的腿被折叠以从其间的线束之一夹紧至少一根电线。然后将该夹紧的线材电阻焊接到带材上。然后将“T”的侧面折叠起来，触摸或接触以形成“DELTA”形状（侧视图）。穿过更远端电极的电线束通过“DELTA”并因此被“DELTA”接合。由例如硅橡胶制成的柔性载体在电线束和折叠电极T之上和之上被模制，优选地以稍微弯曲的形状。铁片被化学蚀刻掉，留下一排间隔开的电极接触面积沿柔性载体的一个边缘，每个边缘电连接到穿过载体的至少一根线。电极阵列可以使用低成本技术制造。

30. 发明授权

US6119044A Cochlear electrode array with positioning stylet 失效
标题翻译：耳蜗电极阵列带定位探针
公开(公告)号：US6119044A
公开(公告)日：2000-09-12
申请号：US259199
申请日：1999-03-01
申请人： Janusz A. Kuzma
发明人： Janusz A. Kuzma
IPC分类号： A61N1/05
CPC分类号： A61N1/0541
摘要： An implantable electrode array, adapted for insertion into either a left or right cochlea, assumes a spiral shape so as to hug the modiolar wall of the cochlea after insertion into the cochlea. All of the electrode contacts are spaced apart along one edge or side of the array, termed the "medial side", which medial side resides on the inside of the spiral. The electrode contacts are thus positioned in close proximity to the modiolar wall, closest to the ganglion cells that are to be stimulated by the electrode array. A positioning stylet made from a suitable memory wire is inserted into a longitudinal channel of the array. The stylet is made from memory wire and has properties selected to return to a desired memory spiral shape at or near body temperature (e.g., approximately 37.degree. C. or 98.6.degree. F.). The positioning stylet is cooled and bent as needed to assume a relatively straight, or non-spiral shape. While relatively straight, the stylet is slidably inserted into the longitudinal channel of the electrode array. The electrode array is then inserted into the cochlea in conventional manner. As the stylet within the electrode array warms to body temperature, it returns to its spiral memory shape, thereby causing the electrode array to also assume a spiral shape, thus positioning the electrode contacts of the electrode array against the modiolar wall.
摘要翻译：适于插入左耳或右耳蜗的可植入电极阵列呈螺旋状，以便在插入耳蜗后拥抱耳蜗的模腔壁。所有电极触点沿着阵列的一个边缘或侧面间隔开，称为“内侧”，内侧位于螺旋内侧。因此，电极接触件位于紧邻由待电极阵列刺激的神经节细胞的模壁上。由合适的存储线制成的定位探针插入到阵列的纵向通道中。探针由记忆线制成，并且具有选定的属性以在体温或接近体温（例如，约37℃或98.6°F）下返回到期望的记忆螺旋形状。定位探针被冷却并根据需要弯曲以呈现相对直的或非螺旋形的形状。虽然相对直的，探针可滑动地插入电极阵列的纵向通道。然后以常规方式将电极阵列插入耳蜗。当电极阵列内的探针温度达到体温时，其回到其螺旋形记忆形状，从而使电极阵列也呈现螺旋形状，从而将电极阵列的电极接触件抵靠模块壁。

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