CN104622638A - 可植入设备 - Google Patents

可植入设备 Download PDF

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CN104622638A
CN104622638A CN201410800222.1A CN201410800222A CN104622638A CN 104622638 A CN104622638 A CN 104622638A CN 201410800222 A CN201410800222 A CN 201410800222A CN 104622638 A CN104622638 A CN 104622638A
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implantation
implant
implantable
magnetic
magnet
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CN104622638B (zh
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杰弗里·R·鲍尔
彼得·兰帕克尔
伯恩哈特·杰姆尼西
马丁·西默林
京特·魏登霍尔策
马库斯·纳格尔
沃尔夫冈·阿姆赖因
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Vibrant Med El Hearing Technology GmbH
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Vibrant Med El Hearing Technology GmbH
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372—Arrangements in connection with the implantation of stimulators
    • A61N1/375—Constructional arrangements, e.g. casings
    • A61N1/37518—Anchoring of the implants, e.g. fixation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
    • A61N1/36038—Cochlear stimulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36125—Details of circuitry or electric components
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
    • A61N1/36142—Control systems for improving safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/18—Internal ear or nose parts, e.g. ear-drums
    • A61F2002/183—Ear parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3718—Monitoring of or protection against external electromagnetic fields or currents

Abstract

本发明涉及可植入设备。描述了一种用于可植入设备的磁体装置。可植入外壳包括可植入电子系统的一部分。该外壳内的圆柱形植入磁体装置包括多个相邻的磁性部分，其中至少两个磁体部分沿相反的磁性方向具有相反的磁性取向。还可以有具有相应磁体装置的相似的外部外壳。

Description

可植入设备
本申请是申请日为2010年7月20日、国际申请号为PCT/US2010/042598、国家申请号为201080033438.X、发明创造名称为“用于可植入设备的磁性附着装置”的中国专利申请的分案申请。
本申请要求2009年7月22日提交的美国临时专利申请61/227,632的优先权，其通过引用并入本文。
技术领域
本发明涉及医疗植入体，更具体地，涉及用于这种植入体的永磁体装置。
背景技术
诸如中耳植入体(MEI)和耳蜗植入体(CI)的一些听觉植入体在可植入部分和外部部分利用附着磁体，以将外部部分磁性地保持在植入体上方的适当位置。例如，如图1所示，典型的耳蜗植入系统可包括外部发送器外壳101，其包含发送线圈102和外部磁体103。该外部磁体103具有传统的硬币形状和垂直于患者皮肤的南北磁偶极，以产生示出的外部磁场线104。植入在患者皮肤以下的是相应的接收器部件105，其具有相似的接收线圈106以及植入的内部磁体107。该内部磁体107也具有硬币形状和垂直于患者皮肤的南北磁偶极，以产生示出的内部磁场线108。内部接收器外壳105通过外科植入并固定于患者体内的适当位置。外部发送器外壳101位于覆盖该内部接收器外壳105的皮肤上方适合的位置，并通过内部磁场线108和外部磁场线104之间的相互作用而保持在适当位置。来自发送线圈102的射频信号将数据和/或能量耦合至接收线圈106，接收线圈106与植入处理器模块(未示出)通信。
当患者经受磁共振成像(MRI)检查时，产生了一个问题。植入磁体与所应用的MRI的外部磁场之间产生了相互作用。如图2所示，该植入磁体202的方向磁化基本垂直于患者的皮肤。因而，来自MRI的外部磁场可在内部磁体202上生成转矩其会使内部磁体202或整个植入体外壳201从适合的位置移出。除此以外，这还可能破坏患者的周围组织。此外，来自MRI的外部磁场可减弱或移除植入磁体202的磁化使其不再有足够的强度而无法将外部发送器外壳保持在适合的位置。内部磁体202还可导致MRI图像的成像伪影，在接收线圈中产生感生电压，以及由于MRI外部磁场与植入设备的相互作用而造成的听觉假象。尤其对于超过1.5特斯拉的MRI场强，更会出现问题。
因此，对于现有的具有磁体装置的植入系统，通常不允许使用MRI或者将MRI的使用限制为较低的场强。其它已有的解决方案包括使用外科可移除磁体、球形植入磁体(例如美国专利7,566,296)，以及各种环形磁体设计(例如2009年7月22日提交的美国临时专利61/227,632)。在不需要外科手术来移除磁体的这些解决方案中，球形磁体设计可能对于MRI移除而言是最方便和最安全的选择，即使位于很高的场强中。但球形磁体装置需要相对大的磁体，比植入体的其它元件厚度大得多，因而增加了植入体占据的体积。这进而会产生其自身的问题。例如，诸如耳蜗植入体的一些系统植入于皮肤与下方骨骼之间。磁体外壳的“球形隆起”因而需要在下方的骨骼内准备一个凹槽。这是在这种应用的植入期间非常具有挑战性的，或者对于低龄儿童甚至是不可能的附加步骤。
在治疗应用中，已有各种复杂的磁性元件装置的描述；例如可参见美国专利4,549,532和美国专利7,608,035。但是，关于这种治疗装置对如上所述的磁性附着体应用可能具有的潜在效益方面，还没有任何建议。
发明内容
本发明的实施例涉及用于可植入设备的磁体装置。可植入外壳包括可植入电子系统的一部分。该外壳内的圆柱形植入磁体包括多个相邻的磁性部分，其中至少两个磁性部分沿相反的磁性方向具有相反的磁性取向。
例如，磁性部分可包括沿内部磁性方向具有内部磁性取向的内部中心盘，以及沿与内部磁性方向相反的外部磁性方向具有外部磁性取向的外部径向环。或者，该磁性部分可包括多个楔形部分，共同组成圆柱形，其中相邻楔形部分沿相反的磁性方向具有相反的磁性取向。或者，该磁性部分可包括内部中心盘，该内部中心盘由具有多个楔形部分的外部径向环所包围，其中相邻楔形部分沿相反的磁性方向具有相反的磁性取向。
多个实施例还具有外壳内的植入信号线圈，该植入信号线圈包围该植入磁体装置，用于接收植入体通信信号。在一些实施例中，可以有多个植入磁体装置。还可以有具有相应的磁体装置的相似的外部壳体。该可植入电子系统可以是例如耳蜗植入系统、中耳植入系统或骨传导听觉植入系统。
附图说明
图1示出了可用于本发明实施例的典型理想化的耳蜗植入体的一部分。
图2示出了外部磁场对可用于本发明实施例的植入设备的植入部分的影响。
图3A-B示出了根据本发明实施例的植入磁体装置。
图4示出了植入磁体装置的实施例如何与典型的外部设备进行协作。
图5示出了植入磁体装置的实施例如何与另一个对应的外部磁体装置进行协作。
图6示出了具有磁性交替的饼形磁性部分的植入磁体的实施例。
图7示出了类似于图6的具有内部中心盘的另一实施例。
具体实施方式
本发明的各种实施例涉及圆柱形磁体形式的、用于可植入设备的改进的磁体装置，其具有多个相邻的磁性部分，至少两个磁性部分在相反的磁性方向上具有相反的磁性取向。
图3A示出了根据本发明实施例的植入磁体装置300的分解顶视图，而图3B示出其侧视图。可植入外壳(例如植入体外壳102)包含可植入电子系统的一部分。该可植入电子系统可为，例如耳蜗植入系统、中耳植入系统或骨传导听觉植入系统。该外壳内部的圆柱形植入磁体装置300包括在内部磁性方向上具有内部磁性取向的内部中心盘部分301，以及在与内部磁性方向相反的外部磁性方向上具有外部磁性取向的外部径向环部分302。
在这种装置中，植入磁体装置300的净磁场比现有技术中传统圆柱形磁体的磁场小得多，但在靠近内部中心盘部分301和外部径向环部分302的局部磁场仍实际上较强，以使植入磁体装置300的固位力在总量上没有减少。植入磁体装置300的这种减小的净磁场还避免了先前的净磁场与植入信号线圈及其通信信号反向地相互作用的问题，并降低了现有技术关于MRI过程的转矩和成像问题。此外，相比于简单的盘式磁体，植入磁体装置300磁性结构更显著的特点还提供了关于外部构件的外壳的改进的中心调整能力。
图4示出了植入磁体装置的实施例如何与典型的外部设备进行协作。传统的圆柱形外部磁体403与根据本发明实施例的具有内部中心盘部分401和外部径向环部分402的植入磁体相互作用。在这种情况下，外部磁体403的直径与植入磁体的内部中心盘部分401近似，使其各自磁场相互作用以提供需要的固位力，以将外部设备保持在适合的操作位置。这使得外部信号线圈405将包括数据和能量的植入体通信信号耦合通过到相应的植入线圈404。由植入线圈404接收的植入体通信信号随后耦合于植入系统的其它元件406，诸如耳蜗植入体的植入处理器、骨传导换能器或中耳换能器。在一些实施例中，可有多个植入磁体装置和相应的外部磁体。
图5示出了植入磁体装置的实施例如何与另一个对应的外部磁体装置进行协作。在这种情况下，外部磁体502还具有内部和外部部分，其对应于植入磁体501的相似部分，以相互协作而将外部设备保持在适合的操作位置。在一些实施例中，可有多个植入磁体装置。这允许外部信号线圈504穿过皮肤505而将包括数据和能量的植入体通信信号耦合于相应植入线圈503，用于由植入系统的其它部件使用。
图6示出了本发明的另一实施例，其中植入磁体装置600包括轴向磁化的楔形部分601，并且相邻楔形部分具有完全相反的磁性方向。图6的植入磁体装置600示出了六个磁化的楔形部分601，而其他实施例可具有不同数量的楔形部分，只要该装置的总净磁场在整体上最小化。此外，图7示出了另一实施例，其具有可被磁化或不被磁化的内部中心盘701，该内部中心盘701由外部径向环702包围，外部径向环702细分为磁化的局部楔形部分703，其中相邻楔形部分以相反方向磁化。在这种装置中(或者，实质上是多个上述实施例)，在单个磁化部分之间还可能有狭窄的未磁化的过渡元件。
如图6和图7所示的实施例允许外部外壳以固定的指定角度附着在皮肤上，这将有助于保证对定向传声器进行适合的对准。当然，对于某些应用这可能被视为缺点，因为取决于楔形部分的数量，外部外壳仅可固定在有限数量的特定角度上。例如，如果植入磁体装置600具有四个轴向磁化楔形部分601，则该外部部分仅能够以180°的角度旋转。如果是六个轴向磁化楔形部分601，则旋转角度是120°。
本发明上述实施例可以容易地且直接地在具有相应的尺寸和几何移位磁体的已有的产品中实现用于植入磁体和/或外部磁体。实施例可有效地包括永久磁性材料和/或铁磁材料以及其他结构材料。其包括但不限于诸如Fe3O4、BaFe12O19等的磁性铁氧材料、诸如塑料粘结永磁粉的复合材料，和/或诸如烧结NdFeB、SmCo等的烧结材料。选择适合的材料和装置可有助于避免或减少不希望的涡流。
尽管已经公开了本发明的多种示例性的实施例，但对本领域技术人员应当清楚，可进行将实现本发明的某些优点的各种改变或修改，而不脱离本发明的真正的范围。

Claims (6)

1.一种可植入设备，包括：
植入体外壳，所述植入体外壳包含可植入电子系统的一部分；以及
圆柱形植入磁体装置，所述圆柱形植入磁体装置位于所述外壳内，包括多个相邻的楔形磁性部分，其中至少两个所述磁性部分沿相反的磁性方向具有相反的磁性取向。
2.根据权利要求1所述的可植入设备，其中所述多个楔形磁体部分形成包围内部中心盘的外部环。
3.根据权利要求1所述的可植入设备，进一步包括：
外壳内的植入信号线圈，所述植入信号线圈包围所述植入磁体装置，用于接收植入体通信信号。
4.根据权利要求1所述的可植入设备，其中所述可植入电子系统包括耳蜗植入系统。
5.根据权利要求1所述的可植入设备，其中所述可植入电子系统包括中耳植入系统。
6.根据权利要求1所述的可植入设备，其中所述可植入电子系统包括骨传导听觉植入系统。
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CN110583029A (zh) * 2017-04-24 2019-12-17 Med-El电气医疗器械有限公司 Mri安全性和力被优化的植入物磁体系统

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