公开(公告)号：US6038484A

公开(公告)日：2000-03-14

申请号：US140034

申请日：1998-08-26

申请人： Janusz A. Kuzma

发明人： Janusz A. Kuzma

IPC分类号： A61F2/18 ,  A61F11/00 ,  A61N1/05 ,  H04R25/00

CPC分类号： A61N1/0541

摘要： An electrode system includes (1) an electrode array, made in a straight or curved shape, but made on a flexible carrier so that it can easily bend within a curved body cavity, such as the cochlea; and (2) a flexible positioner, typically molded in a curved shape from a silicone polymer so as to make it easy to slide into the body cavity. Some embodiments may further include an electrode guiding insert. Yet other embodiments include only a flexible positioner adapted to fill space within a human cochlea so as to force an electrode array against a modiolar wall of the cochlea. Insertion of the electrode array is performed using one of two methods. A first method involves first inserting the flexible positioner into the scala tympani (one of the channels of the cochlea) to a desired depth, which desired depth typically involves a rotation of about 360 degrees and causes the positioner to rest against the outer or lateral wall of the scala tympani, leaving an opening slightly larger than the cross-section of the electrode array adjacent the inner wall of the scala tympani, and then second inserting the electrode array into the opening defined by the positioner and inner wall. The guiding insert may be used, in some embodiments, to assist guiding the electrode array into this opening. A second method of insertion involves first inserting an electrode array into the scala tympani, and then second inserting the positioner into the scala tympani so as to lie between the electrode array and the outer wall of the scala tympani, thereby forcing the electrode array against the inner wall of the scala tympani. Insertion of the positioner into scala tympani after the electrode array has been at least partially inserted therein further carries the electrode array deeper into the scala tympani to a desired final position, and maintains it in that position.

摘要翻译： 电极系统包括（1）电极阵列，其制成直线或弯曲形状，但制成在柔性载体上，使得其可容易地弯曲在弯曲的体腔内，例如耳蜗; 和（2）柔性定位器，通常由硅氧烷聚合物模制成弯曲形状，以使其容易滑入体腔。 一些实施例可以进一步包括电极引导插入件。 其它实施例仅包括柔性定位器，其适于填充人耳蜗内的空间，以便迫使电极阵列抵靠耳蜗的模腔壁。 使用两种方法之一来进行电极阵列的插入。 第一种方法包括首先将柔性定位器插入鼓风鼓（耳蜗的一个通道）到期望的深度，所需的深度通常涉及约360度的旋转，并使定位器抵靠外壁或侧壁 的鼓风鼓，留下比邻近鼓膜内壁的电极阵列的横截面略大的开口，然后将电极阵列第二次插入由定位器和内壁限定的开口中。 在一些实施例中，引导插入件可用于辅助引导电极阵列进入该开口。 第二种插入方法包括首先将电极阵列插入鼓膜鼓中，然后将定位器第二次插入鼓膜鼓中，以便位于电极阵列和鼓膜外壁之间，从而迫使电极阵列抵抗 鼓楼的内墙。 在将电极阵列至少部分地插入其中之后，将定位器插入鼓鼓鼓中，进一步将电极阵列更深地插入鼓风鼓到期望的最终位置，并将其保持在该位置。

公开(公告)号：US20130023972A1

公开(公告)日：2013-01-24

申请号：US13620099

申请日：2012-09-14

申请人： Janusz A. Kuzma ,  Anne M. Pianca

发明人： Janusz A. Kuzma ,  Anne M. Pianca

IPC分类号： A61N1/05

CPC分类号： A61N1/05 ,  A61N1/0551 ,  A61N1/0553 ,  Y10T29/49117 ,  Y10T29/49204 ,  Y10T29/49208 ,  Y10T29/4922

摘要： A lead assembly and a method of making a lead are provided. The method of making a multi-contact lead assembly comprises placing monofilament placed in the void spaces not occupied by the plurality of conductor wires and, in one embodiment, thermally fusing the monofilament to the like material spacer by applying heat just below the melting temperature of the monofilament and spacer material. Alternatively, the monofilament and spacer may be of different materials and heat is applied to cause at least one material to thermally reflow or melt. The conductive contacts may be located at either the distal end and/or proximal end of the lead. Oversized spacers may be used in order to provide extra material to fill voids during the thermal fusion/reflow process.

摘要翻译： 提供引线组件和引线的方法。 制造多接触引线组件的方法包括放置放置在未被多根导线占据的空隙空间中的单丝，并且在一个实施例中，通过施加刚好低于熔融温度 单丝和间隔材料。 或者，单丝和间隔件可以是不同的材料，并且施加热量以使至少一种材料热回流或熔化。 导电触点可以位于引线的远端和/或近端处。 可以使用超大间隔物，以便在热熔/回流过程期间提供额外的材料以填充空隙。

公开(公告)号：US08321028B1

公开(公告)日：2012-11-27

申请号：US12326804

申请日：2008-12-02

申请人： Chuladatta Thenuwara ,  William A. Morgan ,  Janusz A. Kuzma

发明人： Chuladatta Thenuwara ,  William A. Morgan ,  Janusz A. Kuzma

IPC分类号： A61N1/00

CPC分类号： A61N1/37229 ,  A61N1/36036

摘要： An impact resistant implantable antenna coil assembly comprising a flat antenna coil having a plurality of laterally separated turns of wire encapsulated with a non-orthogonal force absorbing coil reinforcement in a flexible biocompatible polymer and axially anchored with the reinforcement to a feedthrough case. Thus configured, non-orthogonal impact forces applied to the antenna coil assembly are absorbed and lateral components thereof that would otherwise be reflected as tensile forces in the plane of the coil are prevented from forming or from fracturing wire within the antenna coil.

摘要翻译： 一种耐冲击植入式天线线圈组件，其包括平面天线线圈，该平面天线线圈具有多个横向分开的导线，其缠绕在柔性生物相容性聚合物中并且与所述加强件轴向锚固到馈通壳体上，所述线圈被非正交力吸收线圈加强件包封。 因此，被施加到天线线圈组件的这种被配置的非正交冲击力被吸收，否则将被反射成线圈平面中的拉力的其横向分量被防止在天线线圈内形成或断裂线。

公开(公告)号：US20090240258A1

公开(公告)日：2009-09-24

申请号：US12406885

申请日：2009-03-18

申请人： Janusz A. Kuzma ,  Anne Margaret Pianca ,  Lani A. Smith

发明人： Janusz A. Kuzma ,  Anne Margaret Pianca ,  Lani A. Smith

IPC分类号： A61B17/00

CPC分类号： A61N1/056 ,  A61B2017/00469

摘要： A detachable handle includes a handle body that is substantially tubular and defines a hollow center region extending at least a portion of a longitudinal length of the handle body. The handle body is configured and arranged to receive a portion of a stylet handle within the hollow center region and removably attach to the stylet handle. The handle body includes an external gripping surface extending at least a portion of an exterior surface of the handle body.

摘要翻译： 可拆卸手柄包括手柄主体，该手柄主体基本上是管状的并且限定了延伸至手柄主体的纵向长度的至少一部分的中空中心区域。 手柄主体被构造和布置成接收在中空中心区域内的探针手柄的一部分并且可移除地附接到探针手柄。 手柄本体包括延伸手柄主体的外表面的至少一部分的外部夹持表面。

公开(公告)号：US07444180B2

公开(公告)日：2008-10-28

申请号：US11138598

申请日：2005-05-25

申请人： Janusz A. Kuzma ,  Tom Xiaohai He ,  Anne Pianca

发明人： Janusz A. Kuzma ,  Tom Xiaohai He ,  Anne Pianca

IPC分类号： A61N1/00

CPC分类号： A61N1/375 ,  A61N1/0551 ,  A61N1/36003 ,  A61N1/37205 ,  A61N1/3756 ,  A61N2001/0578

摘要： An implantable microstimulator can include a housing having a first end; an electronic subassembly disposed within the housing; a plurality of electrodes disposed on the housing and coupled to the electronic subassembly; and a dissecting tip disposed at the first end of the housing. Another implantable microstimulator includes a housing having a first end; an electronic subassembly disposed within the housing; a plurality of electrodes disposed on the housing and coupled to the electronic subassembly; and a extraction aid disposed at the first end of the housing and configured and arranged for attachment of an extraction line.

摘要翻译： 可植入微型刺激器可以包括具有第一端的壳体; 设置在所述壳体内的电子组件; 多个电极，设置在所述壳体上并联接到所述电子子组件; 以及设置在所述壳体的第一端处的解剖尖端。 另一种可植入微型激励器包括具有第一端的外壳; 设置在所述壳体内的电子组件; 多个电极，设置在所述壳体上并联接到所述电子子组件; 以及设置在壳体的第一端处并被构造和布置成用于附接提取管线的提取助剂。

公开(公告)号：US20080195178A1

公开(公告)日：2008-08-14

申请号：US10987561

申请日：2004-11-12

申请人： Janusz A. Kuzma

发明人： Janusz A. Kuzma

IPC分类号： A61N1/00

CPC分类号： A61N1/375 ,  A61N1/0541 ,  A61N1/36036 ,  H04R2225/67

摘要： The present disclosure relates to fixation methods and systems used to secure an implantable medical component in the preferred location of the skull or other bony area of the body. The disclosed fixation methods and systems may be used with a component of a cochlear implant system or other implantable devices, particularly if they are equipped with silicone flaps or flanges, or the like. A mesh reinforcing material overlaps or intertwines into areas of the silicone flanges, which allows for a better distribution of the stress that may occur during the fastening process. Self-tapping screws are used to fasten the implantable component to the skull. The screws are placed in the silicone flanges where the mesh reinforcing material has been embedded. Standard suture-wire may also be used to secure the implantable component to the skull, the implantable component having mounting holes surrounded by the mesh reinforcing material.

摘要翻译： 本公开涉及用于将可植入医疗部件固定在身体的头骨或其他骨区域的优选位置中的固定方法和系统。 公开的固定方法和系统可以与耳蜗植入物系统的组件或其他可植入装置一起使用，特别是如果它们配备有硅胶片或凸缘等。 网状增强材料与硅树脂凸缘的区域重叠或交织在一起，这允许在紧固过程中可能发生的应力的更好分布。 自攻螺钉用于将可植入部件固定在头骨上。 将螺钉放置在嵌入网状增强材料的硅树脂凸缘中。 也可以使用标准缝合线将可植入组件固定到颅骨，该可植入部件具有由网状增强材料包围的安装孔。

公开(公告)号：US06968238B1

公开(公告)日：2005-11-22

申请号：US10635768

申请日：2003-08-05

申请人： Janusz A. Kuzma

发明人： Janusz A. Kuzma

IPC分类号： A61N1/05

CPC分类号： A61N1/0541 ,  A61B17/3468 ,  A61B2017/00787

摘要： An implantable electrode system, adapted for insertion into a cochlea, includes an elongate electrode array stored within a sheath. The electrode array has a multiplicity of electrode contacts carried on a flexible elongate carrier, which carrier is adapted for insertion into one of the spiraling ducts, e.g., the scala tympani, of the cochlea, and further has longitudinal channel or lumen that passes therethrough. 3-6 mm from the distal end of the electrode array. To insert the electrode system into the cochlea, a stylet wire is inserted into the channel or lumen of the electrode array while the electrode array is held within the sheath. The sheath is then removed, and the electrode array is then gently guided and pushed through a cochleostomy into the cochlea by extending the stylet wire to a desired depth. As the electrode array is thus inserted into the cochlea, the stylet wire is retracted and the electrode array remains implanted within the cochlea.

摘要翻译： 适于插入耳蜗的可植入电极系统包括存储在护套内的细长电极阵列。 电极阵列具有承载在柔性细长载体上的多个电极接触件，该载体适于插入到耳蜗的螺旋形管道（例如鼓膜鼓膜）之一中，并且还具有穿过其中的纵向通道或内腔。 距电极阵列远端3-6mm。 为了将电极系统插入耳蜗，将电极阵列保持在鞘内，将探针线插入电极阵列的通道或内腔。 然后去除护套，然后通过将探针线延伸到期望的深度，然后轻轻地将电极阵列引导并通过耳蜗切开进入耳蜗。 由于电极阵列因此被插入耳蜗，所以探针线缩回，并且电极阵列保持植入耳蜗内。

公开(公告)号：US06757970B1

公开(公告)日：2004-07-06

申请号：US10000408

申请日：2001-11-02

申请人： Janusz A. Kuzma ,  William Vanbrooks Harrison ,  Lani A. Smith

发明人： Janusz A. Kuzma ,  William Vanbrooks Harrison ,  Lani A. Smith

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。

公开(公告)号：US06604283B1

公开(公告)日：2003-08-12

申请号：US09519015

申请日：2000-03-03

申请人： Janusz A. Kuzma

发明人： Janusz A. Kuzma

IPC分类号： H01R4300

CPC分类号： A61N1/0541 ,  Y10T29/49174 ,  Y10T29/49179 ,  Y10T29/49181 ,  Y10T29/49183 ,  Y10T29/49185 ,  Y10T29/49208 ,  Y10T29/49218

摘要： A method of manufacturing an electrode array has an elongate flexible carrier that is much more flexible in a first direction than in a second direction orthogonal thereto. The elongate flexible carrier is formed with a bias force that causes the array to flex in the first direction so as to assume the general spiral or circular shape of the scala tympani duct within the cochlea. The less-flexible direction is the direction that makes it difficult for the array to twist as it is inserted within the scala tympani duct. The bias force is sufficiently strong to cause the array to assume its preformed spiral shape even after being straightened during initial insertion into the cochlea. Electrode contacts, embedded into the carrier so as to be exposed along an inner or concave surface of the spiral, thus wrap snugly around the modiolus, thereby positioning the electrode contacts against the modiolar wall in an optimum position for stimulation.

摘要翻译： 制造电极阵列的方法具有细长的柔性载体，其在第一方向上比在与其正交的第二方向上更加柔性。 细长的柔性载体形成有使力阵列在第一方向上弯曲以产生耳蜗内鼓膜鼓风管的一般螺旋或圆形形状的偏压力。 较不灵活的方向是使阵列难以在插入鼓鼓管内扭转的方向。 偏压力足够强，即使在最初插入耳蜗时被拉直之后也使阵列呈现预先形成的螺旋形状。 电极接触，嵌入载体中以沿着螺旋的内表面或凹面暴露，从而紧密地包裹在该膜上，从而将电极接触件抵靠模块壁定位在用于刺激的最佳位置。

公开(公告)号：US06522932B1

公开(公告)日：2003-02-18

申请号：US09783237

申请日：2001-02-13

申请人： Janusz A. Kuzma ,  Carla M. Mann

发明人： Janusz A. Kuzma ,  Carla M. Mann

IPC分类号： A61N105

CPC分类号： A61N1/05 ,  A61N1/0553

摘要： A paddle-type electrode or electrode array is implantable like a percutaneously inserted lead, i.e., without requiring major surgery, and once implanted, expands to provide a platform for many electrode configurations. The electrode array is provided on a flexible, foldable, subcarrier or substrate. Such subcarrier or substrate folds or compresses during implantation, thereby facilitating its insertion using percutaneous implantation techniques and tools. Once implanted, such subcarrier or substrate expands, thereby placing the electrodes in a desired spaced-apart positional relationship, and thus achieving a desired electrode array configuration. A steering stylet may be accommodated in a lumen provided in the subcarrier or substrate. Insertion tools useful with such electrode arrays include a needle with an oblong cross-section, which accommodates the dimensions of the folded array, and also accommodates other electrode arrays that are not necessarily folded.

摘要翻译： 桨状电极或电极阵列可植入如经皮插入的引线，即不需要大量手术，并且一旦植入，扩张以提供用于许多电极构造的平台。 电极阵列设置在柔性，可折叠的副载波或衬底上。 这样的子载波或衬底在植入期间折叠或压缩，从而便于其使用经皮植入技术和工具的插入。 一旦植入，这样的副载波或衬底就会膨胀，从而将电极放置在所希望的间隔开的位置关系中，从而实现所需的电极阵列构型。 转向探针可以容纳在设置在子载波或基板中的内腔中。 与这种电极阵列有用的插入工具包括具有长方形横截面的针，其适应折叠阵列的尺寸，并且还容纳不一定折叠的其它电极阵列。