CN113412090A - 外部调节装置 - Google Patents
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Abstract
一种对植入物进行非侵入式调节的外部调节装置,该外部调节装置包括:控制器,该控制器和与可调节植入物关联的致动器进行通信;以及传感器,其被配置成从可调节植入物接收信息或者接收有关可调节植入物的信息。该外部调节装置还可以包括电源和显示器。根据一个示例性实施方式,该外部调节装置包括:磁性部件,其被配置成生成旋转磁场;以及驱动器,其被配置成驱动磁性部件以生成旋转磁场,并且该驱动器被配置成旋转可调节植入物的永磁体,其中,在将外部调节装置放置得接近具有永磁体的可调节植入物时,将磁性部件配置成与永磁体磁耦合,并且其中,将外部调节装置配置成非侵入式地确定磁性部件和设置在可调节植入物内的永磁体的磁耦合状态和失速状态中的一个或更多个状态。
Description
技术领域
本公开总体上涉及医疗装置领域,更具体地涉及对可调节植入物(implant)进行调节的外部调节装置。
背景技术
提供非侵入式可调节植入物来治疗骨骼系统的各种疾病。然而,这些装置对其外部远程控件的反馈是有限的。可调节植入物的调节指令通常是单向的,并且相应的远程控件不接收有关由可调节植入物实现的实际调节的反馈。因此,用户通常不确信是否实际应用了预期的调节。
发明内容
在一个示例性实施方式中,提供了一种对植入物进行非侵入式调节的外部调节装置,该外部调节装置包括:磁性部件,该磁性部件被配置成生成旋转磁场;以及驱动器,该驱动器被配置成驱动磁性部件以生成旋转磁场,并且该驱动器被配置成旋转可调节植入物的永磁体。
在另示例性实施方式中,提供了一种对植入物进行非侵入式调节的外部调节装置,该外部调节装置包括:控制器;马达;以及被能旋转地联接至马达的至少一个磁体;其中,在将外部调节装置放置得接近可调节植入物时,所述至少一个磁体被配置成,与可调节植入物的永磁体磁耦合;并且其中,在所述至少一个磁体移动时,该控制器被配置成,对所述至少一个磁体与可调节植入物的永磁体的磁耦合状态进行检测。
在另一实施方式中,提供了一种对植入物进行非侵入式调节的外部调节装置,该外部调节装置包括:控制器;马达;以及被能旋转地联接至马达的至少一个磁体;其中,在将外部调节装置放置得接近可调节植入物时,所述至少一个磁体被配置成,与可调节植入物的永磁体磁耦合;并且其中,在所述至少一个磁体移动时,该控制器被配置成,确定所述至少一个磁体与被设置在可调节植入物内的磁体的磁耦合状态。
根据对植入物进行调节的方法,所述方法包括以下步骤:将外部调节装置定位得接近可调节植入物,将所述外部调节装置的至少一个磁体与所述可调节植入物的永磁体进行耦合;通过旋转所述外部调节装置的所述至少一个磁体来生成变化的磁场;对所述外部调节装置的所述至少一个磁体的转速进行监测,以确定所述至少一个磁体与所述可调节植入物的所述永磁体的磁耦合状态。
根据示例性实施方式,提供了一种用于获得外部调节装置的特征化简档(profile)的方法,所述方法包括以下步骤:旋转外部调节装置的磁体;在磁体的转动(revolution)期间,对加速度阵列进行测量;确定加速度阵列的加速度峰值;将加速度阵列移位至中心峰值;对所有测得的加速度阵列求平均;将平均化阵列保存为外部调节装置的特征化简档。
在示例性实施方式中,提供了一种用于确定外部调节装置的磁体与可调节植入物的永磁体的已耦合状态的方法,所述方法包括以下步骤:旋转外部调节装置的磁体;在磁体的转动期间,对加速度阵列进行测量;确定加速度阵列的加速度峰值;将加速度阵列移位至中心峰值;对所有测得的加速度阵列求平均;将平均化阵列与外部调节装置的特征化简档相减以获得测试阵列;以及比较测试阵列的峰峰幅度与阈值,其中,如果测试阵列的峰峰幅度大于阈值,则确定已耦合状态;并且其中,如果测试阵列的峰峰幅度小于阈值,则确定未耦合状态。
在示例性实施方式中,提供了一种使用外部调节装置来确定可调节植入物的永磁体的失速(stalled)状态的方法,所述方法包括以下步骤:旋转外部调节装置的磁体;在磁体的转动期间,对加速度阵列进行测量;确定加速度阵列的加速度峰值;将加速度阵列移位至中心峰值;对所有测得的加速度阵列求平均;将平均化阵列与外部调节装置的特征化简档相减以获得测试阵列;执行测试阵列的快速傅立叶变换(FFT)分析;以及观测FFT的三次谐波,其中,如果满足以下项中的一个或更多个:三次谐波存在以及三次谐波高于阈值,则确定失速状态,并且其中,如果满足以下项中的一个或更多个:三次谐波不存在以及三次谐波低于阈值,则为检测到失速状态,并且磁体已耦合。
附图说明
本领域技术人员通过审阅附图将进一步理解这些和其它的特征,其中:
图1示出了脊柱侧弯患者的脊柱;
图2示出了侧弯脊柱的cobb角;
图3示出了具有被安装在患者脊柱上的永磁体的第一示例性可调节植入物;
图4示出了具有被安装在患者骨骼中的永磁体的第二示例性可调节植入物;
图5示出了根据第一实施方式的外部调节装置的立体图;
图6示出了根据第一实施方式的外部调节装置的侧视图;
图7示出了根据第一实施方式的外部调节装置的正视图;
图8示出了根据第一实施方式的外部调节装置的仰视图;
图9示出了根据第一实施方式的外部调节装置的侧截面图;
图10示出了包括具有内部马达速度传感器的马达的磁体驱动系统的截面图;
图11A示出了外部调节装置的被磁耦合至可调节植入物的永磁体的磁体;
图11B示出了外部调节装置的被磁耦合至可调节植入物的永磁体的磁体;
图12示出了马达控制和编码器检测信号通信示意图;
图13示出了马达的转速标绘图,并且示出了由马达观测到的角速度(RPM)的两个最大值和两个最小值;
图14A示出了跟踪马达转速与时间的关系的图表;
图14B示出了跟踪磁体的已耦合状态与时间的关系的图表;
图15A示出了外部调节装置的磁体,该磁体正被驱动以沿具有非同心旋转轴线的顺时针方向旋转;
图15B示出了外部调节装置的磁体,该磁体正被驱动以沿具有非同心旋转轴线的顺时针方向旋转;
图16A示出了对于外部调节装置的磁体的单次旋转逐滴答(tick)标绘的加速度标绘图;
图16B示出了磁体的多次旋转的标绘图,并且例示了外部调节装置内的从旋转到旋转的可变性;
图17示出了用于获得外部调节装置的特征化简档的方法的流程图;
图18示出了用于确定外部调节装置的磁体与可调节植入物的永磁体的已耦合状态的方法的流程图;
图19A示出了在360度旋转期间由磁体观测到的、被标绘为90次滴答的加速度标绘图;
图19B示出了将已耦合波形变换成频域以区分已耦合状态与失速状态的快速傅立叶变换(FFT)分析;
图19C示出了将失速波形变换成频域以区分已耦合状态与失速状态的快速傅立叶变换(FFT)分析;
图19D示出了将与强耦合状态相对应的波形变换成频域以区分已耦合状态与失速状态的快速傅立叶变换(FFT)分析;
图19E示出了将与弱耦合状态相对应的波形变换成频域以区分已耦合状态与失速状态的快速傅立叶变换(FFT)分析;
图19F示出了将与失速状态相对应的波形变换成频域以区分已耦合状态与失速状态的快速傅立叶变换(FFT)分析;
图20示出了用于确定外部调节装置的磁体与可调节植入物的永磁体的失速状态的方法的流程图;
图21A示出了根据第一实施方式的GUI的LOCK(锁定)画面;
图21B示出了根据第一实施方式的GUI的PATIENT SUMMARY(患者概况)画面;
图21C示出了根据第一实施方式的GUI的SESSION IN PROGRESS(疗程进程)画面;以及
图21D示出了根据第一实施方式的GUI的RX SELECTION(RX选择)画面。
具体实施方式
出于解释而非限制的目的,在下文中,提供某些优选实施方式的细节和描述,使得本领域普通技术人员能够实现和使用本发明。然而,这些细节和描述仅代表某些优选实施方式,并且本领域技术人员通过彻底审阅本文,将容易理解未明确描述的无数的其它实施方式。因此,本公开的任何审阅者都应通过权利要求来解释本发明的范围,并且这样的范围不应被本文中描述和例示的实施方式所限制。
在一般实施方式中,外部调节装置与可调节植入物进行通信。外部调节装置可以包括控制器,该控制器和与可调节植入物关联的致动器进行通信。外部调节装置也可以包括至少一个传感器,所述至少一个传感器被配置成从可调节植入物接收信息或者接收有关可调节植入物的信息。外部调节装置还可以包括电源。根据一个方面,外部调节装置可以包括显示器。根据另一方面,控制器可以从外部调节装置移除。
在一些实施方式中,外部调节装置可以包括:磁性部件,该磁性部件被配置成生成旋转磁场;以及驱动器,该驱动器被配置成驱动磁性部件以生成旋转磁场,并且该驱动器被配置成旋转可调节植入物的永磁体。
在一些实施方式中,磁性部件可以包括磁体,并且驱动器可以包括致动器,该致动器被配置成旋转磁体并且被配置成生成旋转磁场。
在一些实施方式中,磁性部件包括旋转磁体。磁性部件可以包括具有锥状外形的中空旋转磁体,该中空旋转磁体被固定至具有锥状外形的磁体驱动轴。中空旋转磁体可以通过盖帽固定至磁体驱动轴。
驱动器可以包括马达,该马达被配置成旋转磁性部件以生成旋转磁场。例如,马达可以是电动马达。
可以将控制器配置成,可移除地附接至外部调节装置的壳体。控制器可以包括手持式电子装置。例如,控制器可以是智能手机。
外部调节装置可以包括储能装置。例如,可再充电电池和电容器中的一个或更多个。根据权利要求1还包括转速传感器,该转速传感器被配置成,对驱动器的转速和磁性部件的转速中的一个或更多个进行监测。
在一些实施方式中,可以将控制器配置成,确定以下项中的一个或更多个:可调节植入物的永磁体的磁耦合状态和失速(stall)状态。该确定可以包括使用快速傅立叶变换(FFT:fast Fourier transform)来变换加速度阵列并且观测快速傅立叶变换(FFT)的三次谐波。
除了本领域技术人员容易理解的常见定义之外,如本文所使用的,快速傅立叶变换(FFT)可以被认为是计算序列的离散傅立叶变换(DFT:discrete Fourier transform)或该序列的离散傅立叶逆变换(IDFT)的算法。傅里叶分析将信号从其原始域(通常是时间或空间)转换成频域下的表示,反之亦然。
图1示出了患有脊柱侧弯(scoliosis)的患者100的例示图。患者100可以包括人类或任何哺乳动物。可以在患者100的左侧104上看到脊柱弯曲的凹入部分102,并且可以在患者100的右侧108上看到凸出部分106。在一些患者中,凹入部分102可能出现在患者100的右侧108,而凸出部分106可能出现在患者的左侧104。另外,如在图1中看到,存在脊柱110的某一旋转,并且看到左肩112与右肩114之间的不平整(unevenness)。
图2例示了脊柱侧弯患者的脊柱110的Cobb角116。为了确定Cobb角,分别从椎骨122和124绘制线118和120。通过从线118和120创建90°角130和132来绘制相交的垂直线126和128。由垂直线126和128的交叉创建的角116被定义为Cobb角。在完美笔直的脊椎中,这个角是0°。
图3例示了根据一个实施方式的用于治疗脊柱侧弯的可调节植入物200。将可调节植入物200的上端202和下端204固定至患者的脊柱500。脊柱500的例示示例包括通常包含脊柱侧弯曲线的特定胸椎和腰椎,例如患有青少年特发性脊柱侧弯的患者的曲线。图3不是以严重的脊柱侧弯、而是以表示在植入手术期间已经部分或完全矫直的适度曲线的非常轻微的残留曲线,分别描绘了T3到T12胸椎503、504、505、506、507、508、509、510、511、512以及L1到L3椎骨513、514、515。
各椎骨的大小和形状都与其它椎骨不同,并且上椎骨通常小于下椎骨。然而,通常,椎骨具有相似的结构并且包括椎体(vertebral body)516、棘突(spinous process)518、520、椎板(laminae)526、横突(transverse processe)521、522以及椎弓根(pedicle)524。
在该实施方式中,可调节植入物200包括可经由联接的可调节部分208调节(纵向)的牵引杆206。牵引装置是经由处于牵引杆206的上端202的夹具600固定至脊柱500的。在图3中,将夹具600绕T4椎骨504的横突521进行固定。另选地,可以将夹具600绕相邻的肋骨(未示出)或肋骨小面(rib facet)进行固定。还在另一另选例中,可以将夹具替换成椎板和椎弓根钩系统或者椎弓根螺钉系统。示例性椎弓根钩系统或椎弓根螺钉系统可以在美国专利申请序列号No.12/121,355和No.12/250,442中找到,它们就像在本文中完全陈述一样通过引用而并入。
返回参照图3,可调节植入物200被例示为利用椎弓根螺钉系统531固定至脊柱500,椎弓根螺钉系统531包括连接杆532和两个脚趾夹(toe clamp)538、540。连接杆532然后与可调节部分208对接。可调节植入物200的可调节部分208包含磁性组件210(如虚线所示),该磁性组件具有被配置成驱动导螺杆的永磁体262,该导螺杆根据内部磁体的旋转方向,使用可调节部分208来使牵引杆206伸出或缩回。例如,牵引杆206的伸长将向脊柱500施加牵引力。例如,如果牵引力太高而导致疼痛或并发症,则缩回牵引杆206将会降低或去除脊柱500上的牵引力。例如,在脊柱的前部或者在曲线的凸部处,甚至可能需要使用该装置来压缩脊柱或骨骼。在一些实施方式中,可调节植入物可以包括牵引装置。供在牵引装置中使用的各种磁性组件210的示例可以在美国专利申请序列号No.12/121,355和No.12/250,442中找到。
仍参照图3,可以松开锁定螺钉534以将连接杆532的角度调节到期望的取向,然后可以拧紧锁定螺钉534,以使脚趾夹538牢固地将连接杆532保持就位而不会进一步旋转。以相同方式通过拧紧锁定螺钉536来调节第二脚趾夹540。因为侧弯脊柱也发生了旋转(在AIS患者中通常是中心部分向右旋转),所以这里呈现的非融合实施方式允许脊柱500的反旋转自然发生,这是因为在可调节植入物200的中间部分处没有进行固定。
为了进一步促进这种反旋转,可调节植入物200可以允许在其端部处自由旋转。例如,可以将可调节部分208经由铰接接头联接至连接杆532。美国专利申请序列号No.12/121,355和No.12/250,442描述了可以用于将可调节部分108联接至连接杆532等的各种铰接接口和接头。
应注意,牵引杆206可以预先弯曲成具有正常矢状脊柱(saggital spine)的典型形状,但还应注意,曲线可能与标准脊柱侧弯融合手段略有不同,这是因为在此处描述的非融合实施方式中,可调节植入物200不与脊柱齐平,而相反是放置在皮下或者筋膜下(subfascial),因此不在背部肌肉下方。可调节植入物200的唯一被设计为放置在肌肉下方的部分是夹具600和牵引杆206的紧邻夹具600、椎弓根螺钉系统531以及连接杆532的部分。因此,图3例示了其中与可调节植入物200关联的大部分硬件被放置在肌肉上方的实施方式。然而,应理解,在另选配置中,整个可植入实施方式的任何其它部分均可以被放置在肌肉下方(即,肌肉下)。应意识到,与当前的融合手术相比,在手术期间需要解剖的肌肉量要少得多。这将允许手术时间更短、失血更少、恢复得更快,并且住院时间更短/感染风险更低。此外,可能期望生成连接杆532的“J”曲线或者生成连接杆532的在可选凸缘或肋处的最高应力点处的任何其它曲线,以便增加它们在苛刻(demanding)植入条件下的耐久性。
图4例示了根据另选实施方式的可调节植入物200,该可调节植入物200包括通过近端固定构件276和远端固定构件278附接至具有近端部分258和远端部分260的骨骼生长装置。固定构件276、278可以使用任何数量的固定装置或者已知的将装置附接至骨骼的方法(包括螺钉、夹具甚或粘合剂材料)来进行操作。在骨折的情况下,例示了骨折部位274,但应注意,这种骨折并不总是存在于某些应用中。如在图4中看到,可调节植入物200包括磁性组件210,该磁性组件210包括永磁体262,该永磁体262被配置成响应于外部施加的磁场而绕其轴线旋转。永磁体262的旋转实现行星齿轮组266的旋转。可选的滑动离合器264被例示为设置在永磁体262与行星齿轮组266之间,不过可以将滑动离合器264沿着驱动传动装置设置在任何其它位置处。行星齿轮组266沿第一方向(例如,根据配置沿顺时针或逆时针)的旋转导致导螺杆268在内螺纹270内转动,从而导致骨骼256的牵引(例如,延长)。骨骼生长牵引装置272可以在单次手术中植入。后续的调节是以非侵入式方式执行的,并且若需要的话,可以频繁执行调节以便精确地控制骨骼生长。骨骼牵引的示例性每日调节为1mm。可以使用诸如本文所描述的外部调节装置700的调节装置来旋转永磁体262。本文所描述类型的外部调节装置700也可以用于通过磁耦合至图3所例示的可调节植入物200的磁性组件210来牵引和缩回该可调节植入物。永磁体262例如可以包括柱形磁体。
本领域技术人员可以意识到,尽管本文中包括了可调节植入物的某些例示实施方式,但是预期并且本公开旨在包括被配置成由外部调节装置(例如包括可调节的髓内钉)调节的所有已知的可调节植入物。
图5示出了用于调节可调节植入物的示例性外部调节装置400的立体图。外部调节装置400可以包括具有手柄402和显示器403的壳体401。在一些实施方式中,可以将显示器403与外部调节装置400的壳体401进行集成。在所例示的实施方式中,将外部调节装置400配置成容纳具有显示器403的可移除控制器410,并且显示器403是可移除控制器410的组成部分。
根据示例性实施方式,控制器410可以是手持式电子装置。手持式电子装置例如可以是智能手机、平板电脑以及任何其它已知的手持式电子装置。手持式电子装置可以包含并且可以在工作上连接至显示器和/或一个或更多个无线通信协议(例如,Wi-Fi或)。可以将手持式电子装置的显示器设置得与外部调节装置400的表面相邻,使得显示器403可以在使用期间向用户传达信息和接收来自用户的指令。
例如,在一些实施方式中,显示器403可以向用户呈现图形用户界面(GUI)。显示器403可以包括触摸屏或触摸屏技术中的一种或更多种,例如包括电容式触摸屏技术。GUI可以向用户传达可以对应于治疗方案的调节指令,以指导用户根据治疗方案调节可调节植入物。另外,GUI可以包括一个或更多个触摸屏数字按钮,该触摸屏数字按钮被配置成启用和控制外部调节装置400。
图6示出了根据第一实施方式的外部调节装置400的侧视图。所示的把手403从壳体401起向上延伸。图7示出了外部调节装置400的正视图,外部调节装置400包括电源输入端422和数据连接端口412。另外,壳体401的底表面被示出为包括曲率,该曲率被配置成针对患者的身体形成并且最小化磁体440与可调节植入物的永磁体262之间的距离(GAP)。可以将电源输入端422配置成可移除地接收AC电源。可以将数据连接端口412配置成可移除地容纳数据通信线缆。可以将数据通信线缆配置成,将外部调节装置400连接至第三装置,以进行更新控制器410软件和从控制器410下载数据中的一个或更多个。
图8示出了外部调节装置400的仰视图,壳体401的底表面被示出包括曲率,该曲率被配置成针对患者的身体而形成并且最小化磁体440与可调节植入物的永磁体262之间的距离(GAP)。
图9示出了根据第一实施方式的外部调节装置400的侧截面图。所示的外部调节装置400包括壳体401、控制器410、内部储能装置420、马达430以及至少一个磁体440。
内部储能装置420以及控制器440的无线通信能力可以提供外部调节装置400的无线操作。内部储能装置420可以在操作期间消除对电源线的需要。控制器410可以提供不需要大体积外部控制模块的低压控制系统。而且,无线通信能力(例如,RF、Wi-Fi、中的一种或更多种)可以使得外部调节装置400和控制器410能够进行远程操作。远程操作可以通过同一房间的第三装置以及通过地球另一侧的第三装置跨互联网中的一者或更多者来实现。
在一些实施方式中,控制器410可以是被设置在外部调节装置400的壳体401内的控制板。显示器403可以包括任何类型的显示器403,例如包括:LED、LCD、OLED以及任何其它已知的显示和触摸屏技术。控制接口板411可以包含或者与一个或更多个通信电路(例如,Wi-Fi、蜂窝网络或中的一种或更多种)进行通信,使得能够在外部调节装置400与一个或多个第三装置之间进行通信。
在图9中,控制器410被示出为通过至少一个互连部在工作上(operably)连接至控制器接口板411。在一些实施方式中,该连接可以经由如图所示的物理连接以及在一些实施方式中经由无线连接(例如,)来建立。还可以将控制接口板411连接至电力接口板421、储能装置420以及致动器430中的一个或更多个。
控制器410可以由第三(tertiary)装置远程访问和远程控制,从而允许用户从无菌区外远程操作外部调节装置400。
外部调节装置400也被示出为包括内部储能装置420。储能装置420可以包括电池、电容器以及在本领域中已知和使用的任何其它储能装置。储能装置可以是可再充电的,并且外部调节装置400可以包括被配置成使用外部电源对储能装置420进行再充电的再充电电路。外部电源(例如,电源(power supply))可以经由电源输入端在工作上连接至储能装置的再充电电路。可以将储能装置420和/或再充电电路的至少一部分设置得与外部调节装置400的表面相邻,从而使得电源充电线缆能够连接至外部调节装置400。在一些实施方式中,再充电电路可以使得内部储能装置420能够使用感应无线传递电力来进行无线充电。在一些实施方式中,再充电电路可以是配电板421和储能装置400中的一个或更多个的一部分并连接至配电板和储能装置中的一个或更多个。
在所例示的实施方式中,储能装置420是电池。电池420安装至外部调节装置400的底盘。与外部调节装置400的表面相邻,使得能够在电源输入端422处将电源连接至外部调节装置400。电池420包括电力接口板421,该电力接口板421被配置成与马达430对接并且向马达传送电力。可以将电力接口板421在工作上联接至马达430和控制接口板411中的一个或更多个。电力接口板421还可以从电源输入端422和储能装置420中的一个或更多个向控制器410传送电能。
外部调节装置400的致动器包括电动马达430。外部调节装置400的驱动器包括被可旋转地联接至电动马达430的磁体440。可以将马达430在工作上连接至控制器410、控制接口板411、电力接口板421以及内部储能装置420中的一个或更多个。在所例示的实施方式中,将电动马达430通过电力接口板421在工作上连接至内部储能装置420。电力接口板421可以包括配电电路,以将电能从电源输入端422和内部储能装置420中的一个或更多个传送至电动马达430。也可以将电力接口板421在工作上连接至控制接口板411,以将控制信息从控制器410中继至马达430。在一些实施方式中,控制器410可以与马达430直接通信,并且在一些实施方式中,控制器410可以经由无线连接(例如,连接)连接至电动马达。
马达430可以包括能够旋转磁体440的任何类型的马达。马达430是电动马达并且可以包括转速传感器432。转速传感器432连接至控制接口板411和控制器410中的一个或更多个并与之进行通信。在一些实施方式中,内部速度传感器432例如可以包括编码器和电动马达的数字输出端中的一个或更多个。在一些实施方式中,将马达430配置成,以无线方式将转速数据传送至控制器410。
图10示出了根据第一实施方式的外部调节装置400的马达430和磁体440的增强截面图。磁体440被示出为通过一个或更多个联接器431可旋转地联接至马达430。在所例示的实施方式中,磁体440包括具有内表面442并且具有锥状外形的内腔441。磁体驱动轴433被示出包括具有锥状外形的磁体接触表面434。将磁体驱动轴433的锥状外形配置成与磁体440的内表面442的锥状外形连通。这使得磁体440能够通过摩擦配合固定至磁体驱动轴433,将磁体440配置为成通过盖帽435和连通的锥状外形保持到磁体驱动轴433上。在一些实施方式中,可以将磁体440使用粘合剂材料附接至磁体驱动轴433。
磁体440可以包括任何磁性部件,包括:径向极化柱形磁体、永磁体、电磁体以及在本领域中已知和使用的任何其它磁性部件。将磁体440配置成,与可调节植入物的永磁体262进行磁耦合以及旋转永磁体262并调节可调节植入物200。在磁体440旋转时,将生成旋转磁场,从而在可调节植入物200的磁耦合永磁体262上施加力,由此引发永磁体262的旋转和可调节植入物200的后续调节。
在一些实施方式中,外部调节装置400包括一个或更多个传感器,所述一个或更多个传感器被配置成对磁体440的转速进行监测。在一些实施方式中,传感器包括磁性传感器(例如,被设置在壳体401、板以及底盘中的一个或更多个上的霍尔效应传感器),并且可以被放置得与磁体440相邻。在一些实施方式中,传感器包括光电传感器。磁体可以包括一个或更多个圆形光学编码器条以与光电传感器一起工作。美国专利申请序列号No.14/932,904描述了对由非侵入式可调节植入物生成的力进行非侵入式检测的各种系统和方法,其全部内容通过引用并入于此。
在所例示的实施方式中,外部调节装置400包括具有一个或更多个转速传感器432的马达430,该转速传感器432被配置成检测马达角速度(V)的变化,从而如下所述对可调节植入物200的永磁体262的旋转进行非侵入式检测。马达430具有以下转矩特性:当不存在被定位得靠近ERC磁体或者被磁耦合至磁体440的植入物或含铁材料时,允许在马达旋转和对应磁体440旋转期间马达角速度(V)的小变化。
当具有永磁体262的可调节植入物200接近旋转磁体440以及例如被磁耦合至磁体440时,两个磁体的磁极导致马达430上的负载每转(per revolution)变化两次。这导致磁体440的角速度增加或减少,并且该变化可由转速传感器432检测。
在图11A中,外部调节装置400的磁体440被示出为沿第一顺时针方向旋转,并且植入物的永磁体262被示出为磁耦合至磁体440并且沿第二逆时针方向旋转。本领域技术人员可以意识到,随着马达430驱动磁体440旋转,磁体440和永磁体262的相应磁极将彼此吸引,从而当磁极朝着彼此指向时,在马达430上施加减小的负载以驱动旋转。在图11B中,随着马达430继续驱动磁体440旋转,磁体440和永磁体M的相应磁极仍会彼此吸引,从而当磁极远离彼此指向时,在马达430上施加增加的负载以驱动旋转。负载的这些变化导致可以由马达430的转速传感器432检测到的角速度的可观测变化。
转速传感器432对马达430的角速度(该角速度对应于磁体440的角速度)进行测量,并且将角速度传送至控制器410。在一些实施方式中,角速度可以根据从马达430获得的正交编码器信号来进行检测。编码器提供电子脉冲或信号,该电子脉冲或信号表示磁体440的转动中的一步的“滴答(tick)”。在该实施方式中,例如,编码器可以在磁体440的每转发送90次“滴答”,或者在整个360度旋转中每4度发送一次“滴答”。每旋转使用的“滴答”数可以是选择的任何数量,并且可以取决于给定测量所期望的分辨率量。控制器410和控制接口板411中的一个或更多个可以提供马达430的控制电路,以及编码器信号的检测电路,并且可以包括内部速度传感器432。
图12示出了用于角速度和远程磁体旋转检测的马达430控制信号和编码器413检测信号的图。主板(其可以包括控制接口板411)可以向马达430传送指令。编码器432可以返回表示磁体440的转动中的一步的“滴答”的脉冲。使用表示每n度的“滴答”的所返回的编码器信号,可以使用下式以rpm来计算角速度:
其中:t等于一分钟内的秒钟数(60秒钟/min),Rt等于每转的滴答数(在该实施方式中,其为90次滴答/转),以及Tt是观测到的滴答之间的时间(以秒钟为单位)。使用该式,可以使用所检测到的每滴答的滴答之间的时间差来获得所计算出的角速度。
图13示出了在将磁体440耦合至永磁体262的情况下,该磁体440的转动的角速度的测得的图表。注意,存在两个观测到的最大峰值和两个观测到的最小峰值,它们对应于磁体转动期间沿磁极的负载变化,如上所讨论的。
外部调节装置400的磁体440是否与可调节植入物200的磁体262磁耦合的二元观测可以通过对马达430的转速或角速度与平均值的紧密结合程度进行监测来获得。
图14A示出了随着将磁体440耦合至可调节植入物200的永磁体262并对该永磁体进行调节,测量马达430的转速随时间标绘的图表。
首先,在未磁耦合状态下,马达430的速度保持与平均值紧密结合。在未磁耦合状态下,外部调节装置400的磁体440响应于由马达430提供的转矩而自由旋转,并且不受来自可调节植入物200的已耦合永磁体262的任何附加影响。
在已磁耦合状态下,在马达430的速度中观测到较大的波动,这是由于来自可调节植入物200的已耦合永磁体262的附加影响。
因此,通过测量外部调节装置400的磁体440的转速,人们可以确定磁体440与可调节植入物的永磁体262是处于已磁耦合状态还是处于未磁耦合状态,如图14B所示。可以将该确定传送至控制器410,并且随后显示给用户,非侵入式地向用户提供:再保证磁体440在治疗期间耦合至可调节植入物200的永磁体262。
通过测量磁体440的转速,可以检测以下项中的一个或更多个:磁耦合状态;永磁体262的失速;相对GAP估计;以及相对力估计。
GAP是从外部调节装置400的磁体440到可调节植入物200的永磁体262的距离。GAP可以通过测量外部调节装置400的、与可调节植入物200的永磁体262处于已磁耦合状态的磁体440的转速来进行估计。针对特定单元的GAP基准可以在初始(例如,在制造期间)进行校准。为了获得该基准,可以在已知的GAP距离处测量磁体的转速。转速波形的振幅将响应于磁体440与永磁体262之间的距离(GAP)的变化并与该变化成比例地改变。速度图表的观测到的幅度将与相对距离成正比地改变,从而允许控制器410估计GAP距离。
还可以通过观测外部调节装置400的至少一个磁体440随时间的转速来估计由可调节植入物施加的力。通过测量所示至少一个磁体440的转速并同时估计GAP,可以估计正被施加至可调节植入物200的永磁体262的力的估计。
在一些实施方式中,可调节植入物200可以具有一个或更多个行星齿轮组,所述一个或更多个行星齿轮组被配置成改变由可调节植入物200的永磁体262递送的力的量。可以将特征属性编程到外部调节装置400和控制器410中的一个或更多个中,或者可以通过可调节植入物200传送至外部调节装置400和控制器410中的一个或更多个。本领域技术人员可以意识到,可以使用例如可调节植入物的RFID标签、射频通信、超声通信、Wi-Fi连接以及本领域已知的任何其它类型的通信来实现这种通信。
失速(stalling)是可调节植入物200的永磁体262无法响应于外部调节装置400的磁体440的旋转而旋转。为了检测可调节植入物200的永磁体262的失速状态,需要对磁体440的角速度的更高分辨率测量。
在一些实施方式中,这可以通过计算磁体的加速度(ΔV)来实现。例如,从初始滴答的角速度中减去最后滴答的角速度,可以确定当前滴答的瞬时加速度。该减法过程可以在贯穿磁体440的整个转动(revolution)发生。由于磁体速度斜率可能会发生变化,因此加速度ΔV也可能会发生变化。这提供了与转动期间的变化的速度关联的两个最大峰值以及两个最小峰值。当磁体440的角速度处于最大或最小峰值时,由于速度斜率为零,因此加速度将为零(在轴线上)。
在以更高的感测分辨率监测加速度的情况下,在外部调节装置400内存在变量,即使植入物未处于磁体440附近,该变量也可以使磁体440的加速度发生变化。
例如,当外部调节装置400与可调节植入物的永磁体262未耦合时,如图15A和图15B所示,因磁体440相对于其旋转轴线R的旋转缺乏同心度而可以产生外力。
图15A示出了外部调节装置400的磁体440,该磁体正被驱动以沿顺时针方向旋转,如图所示。本领域技术人员可以意识到,将磁体440配置成绕第一轴线R旋转。注意,第一轴线R与磁体440的质心不同心。因此,随着每次旋转,重力将添加每次旋转的增加的力,这可能看起来类似于已耦合的永磁体262,并且负载的这些变化导致可以由马达430的内部速度传感器432检测到的速度和加速度的可观测变化。
在图15A中,随着马达430继续驱动磁体440旋转,非同心旋转轴线将导致从重力上观测到的大转矩,从而首先在马达430上施加减小的负载以驱动旋转。如图15B所示,在磁体440到达其整个旋转的底部之后,马达430将由于马达430上的增加的负载而了解增加的负载,以继续驱动旋转。
可能导致磁体在其旋转期间加速和减速的其它变量包括:轴内的摩擦点、马达机构内的摩擦点、具有两个或更多个磁体(其中两个或多个磁极在旋转期间彼此吸引和排斥)的外部调节装置、位于外部调节装置400内部和附近的其它含铁金属。
图16A示出了对于外部调节装置400的磁体440的单次旋转逐滴答(tick to tick)所取的加速度标绘图。图16B示出了磁体440的多次旋转的标绘图,并且例示了外部调节装置内的从旋转到旋转的可变性。注意加速度幅度的变化,甚至可能导致相移。
加速度/减速度简档和特性对于从单元到单元的各个外部调节装置而言可以是唯一的。造成这种情况的原因可以包括:制造方法,和对从磁体到磁体的同心度变化的个体一致性,以及上述其它因素。
例如,完美同心的磁体、无摩擦的驱动机构、连同在操作期间外部调节装置内部和周围没有含铁金属,可以贯穿磁体440的所驱动的转动来提供恒定为零的理想加速度/减速度简档。因此,检测到的加速度/减速度的任何变化将与可调节植入物200的永磁体262关联,从而允许失速检测以及深感测范围(跨大GAP的测量)所需的改进的检测性能。
提供了一种减轻外部调节装置400固有的不期望的加速度/减速度特性的方法,该方法包括以下步骤:确保磁体440与植入物的永磁体未耦合,通过在外部调节装置磁体正在旋转时记录加速度/减速度简档来获得特征化简档。一旦确定了外部调节装置的独特的特征化简档,就可以将其保存至存储器。
由于特征化简档波形因外部调节装置至装置而异,并且因旋转而异。每次旋转皆可以将多个简档样本捕获到90元素阵列中。通过对所捕获的所有旋转简档阵列中的各个元素求平均来创建特征化简档阵列。在求平均之前,检测各个旋转阵列的加速度峰值。来自各个旋转阵列的各检测到的加速度峰值都向中心移位(元素45)。这将过滤任何相移。确定所有阵列的各个元素的平均值,并且存储外部调节装置400的特征化简档。
图17示出了用于获得外部调节装置400的特征化简档的方法的示例性流程图,该方法包括以下步骤:验证在外部调节装置400附近没有植入物和含铁材料,旋转外部调节装置400的磁体440,在磁体440旋转期间测量加速度阵列,确定加速度阵列的加速度峰值,将加速度阵列向中心峰值移位,对所捕获的所有加速度阵列求平均,以及将平均化阵列保存为外部调节装置400的特征化简档。在一些实施方式中,获得逆时针特征化简档。在一些实施方式中,获得顺时针特征化旋转简档。在一些实施方式中,可以获得两个简档,并且可以一起求平均。
外部调节装置400使用所保存的特征化简档作为基准,以过滤在使用期间观测到的继承的和可能不期望的磁体加速度/减速度。当外部调节装置400的磁体440正在旋转时,对阵列进行捕获达预定旋转次数。与获取特征化简档的步骤类似地,检测各个阵列加速度峰值元素并将其向阵列中心移位。对预定数量的旋转阵列中的各个元素的平均值求平均,并且捕获和保存平均化(Averaged)旋转阵列波形。
然后,可以将平均化旋转阵列波形与特征化简档进行比较。通过从平均化旋转阵列中减去特征化简档,我们可以获得测试阵列。
如果外部调节装置400在该外部调节装置400的磁体440附近没有植入物的情况下未耦合,则平均化旋转阵列波形看起来类似于特征化简档。减去这些阵列将使所有元素的测试阵列接近零。检查测试阵列的较小的峰值幅度,并且与预定阈值进行比较。如果测试阵列波形峰峰幅度低于阈值,则外部调节装置400在其使用期间检测到未耦合状态。
如果外部调节装置400的磁体440与靠近磁体440的可调节植入物200的永磁体262耦合,则在所捕获的阵列中将观测到可测量的加速度和减速度。与上述讨论类似地,由于永磁体262的接近而造成的磁体440的更大加速度/减速度,所捕获的已耦合阵列的波形幅度明显大于未耦合阵列。可以对这些较高幅度的加速度/减速度阵列求平均,并且从较低幅度特征化简档中减去这些较高幅度的加速度/减速度阵列。这两个阵列的减去仍然生成高幅度测试阵列。将该测试阵列与用于检测未耦合状态的相同预定阈值进行比较。如果测试阵列波形峰峰幅度高于阈值,则外部调节装置400在其使用期间检测到已耦合状态。
图18示出了用于确定外部调节装置400的磁体440与可调节植入物200的永磁体262的已耦合状态的方法的示例性流程图,该方法包括以下步骤:旋转外部调节装置的磁体;在磁体的转动期间,对加速度阵列进行测量;确定加速度阵列的加速度峰值;将加速度阵列移位至中心峰值;对所捕获的所有加速度阵列求平均;从外部调节装置的特征化简档减去平均化阵列以获得测试阵列;以及比较测试阵列的峰峰幅度与阈值,其中,如果测试阵列的峰峰幅度大于阈值,则确定已耦合状态;并且其中,如果测试阵列的峰峰幅度小于阈值,则确定未耦合状态。
在一些实施方式中,可以将所检测到的状态传送至控制器410。在一些实施方式中,可以将所检测到的状态通过显示器403显示给用户。在一些实施方式中,可以将所检测到的状态传送至马达430。在一些实施方式中,可以将检测到的状态可以传送至第三装置。
检测失速需要对检测外部调节装置400的磁体440的角速度的更高检测分辨率。这可以通过计算磁体440的加速度(ΔV)来实现。通过从先前检测到的滴答的先前速度(ΔV)中减去当前检测到的滴答的角速度,可以确定当前滴答的瞬时加速度。这个减法过程贯穿整个转动发生,例如,与所有360度旋转相对应的所有90次滴答。由于外部调节装置400的磁体440的速度斜率确实改变,因此ΔV确实改变。这提供了与转动中的变化的速度关联的两个最大峰值以及两个最小峰值。当磁体440的角速度处于最大或最小峰值时,由于速度斜率为零,因此加速度将为零(在轴线上)。
图19A示出了在360度旋转期间由磁体440观测到的加速度的波形。将360度旋转分解成90次滴答,并且以每次滴答观测瞬时加速度(ΔV)。该标绘图包括四个阵列,包括失速旋转A、已耦合旋转B、未耦合旋转C以及未耦合平均化D。
在一些实施方式中,外部调节装置可以分析加速度阵列的快速傅立叶变换(FFT)的三次谐波以确定失速状态。在图19B中,示出了快速傅立叶变换(FFT)将已耦合旋转B阵列转化到频域中,以通过分析三次谐波来区分已耦合状态与失速状态。在图19C中,示出了快速傅立叶变换(FFT)将失速旋转A阵列传递到频域中,以通过分析三次谐波来区分已耦合状态与失速状态。与图19B相比,注意,在失速状态下,观测到波形的快速傅立叶变换(FFT)的三次谐波的幅度显著增加。FFT的3次谐波在已耦合状态E缺失,而在失速状态F存在。
由于通过可调节植入物200的失速永磁体262施加在外部调节装置400的磁体的旋转上的大量阻力,因此,失速可能导致磁体440的加速度和转速的大波动。另外,通过磁体440观测到的因永磁体262的磁场而造成的添加的力,磁体440的旋转可能不太同心并且不太紧密结合平均值。
通过进行快速傅里叶变换(FFT)并查看频域中的角速度标绘图,我们可以观测到不期望的干扰和错误的失速信号。例如,如果将磁体440耦合至可调节植入物200的内部永磁体262并使其旋转,并且将外来含铁金属片引入并放置在系统附近,那么即使可调节植入物200的内部永磁体262实际上与磁体440一起旋转,系统也可能被欺骗检测到失速。在频域下,外来金属片会在FFT标绘图引入附加的频率信号,我们可以将这样的频率信号滤除并忽略。从而防止错误的失速检测。
快速傅立叶变换(FFT)之间存在多个不同之处。然而,可以将该技术用于添加其它组件以区分失速以及区分磁体440附近的外部含铁金属,该外部含铁金属会破坏用于检测植入物状态的感测性能。
在一些实施方式中,外部调节装置400可通过分析快速傅立叶变换(FFT)并且取第一频率分量和第二频率分量的相应幅度的比率来区分失速状态。检测阈值是与该比率关联的值。存在因永久性植入物262靠近磁体440而造成的FFT的幅度变化。在已耦合状态下,第一频率分量和第二频率分量的观测到的比率高于阈值。在失速状态下,第一频率分量和第二频率分量的观测到的比率低于阈值。
例如,在图19D中,示出了对应于强耦合状态的快速傅立叶变换(FFT),例如其中,将磁体440耦合至具有小GAP的永磁体262并旋转该永磁体。在这里,我们观测到以2Hz为中心的二次谐波(其等于0.18),并将该二次谐波除以以4Hz为中心的四次谐波(其等于0.025)。求取该比率,我们得到的值为7.2。
在图19E中,示出了对应于弱耦合状态的快速傅立叶变换(FFT),例如其中,将磁体440耦合至具有大GAP的永磁体262并旋转该永磁体。在这里,我们观测到以2Hz为中心的二次谐波(其等于0.48),并将该二次谐波除以以4Hz为中心的四次谐波(其等于0.004)。求取该比率,我们得到的值为12。
现在,在图19F中,示出了对应于失速状态的快速傅立叶变换(FFT),例如其中,磁体440未耦合至永磁体262并且未旋转该永磁体。在这里,我们观测到以2Hz为中心的二次谐波(其等于0.04),并将该二次谐波除以以4Hz为中心的四次谐波(其等于0.016)。求取该比率,我们得到的值为2.5。
因此,基于这些图表,比率比较的阈值必须介于7.2与2.5之间。数据显示,对于多植入体配置,比率比较的阈值约为6.5,其中低于6.5的比率值表示失速状态。现在,本领域技术人员可以意识到,可以通过控制器和外部调节装置中的一个或更多个来获得如本文所示出和描述的这些和其它计算。可以在使用期间利用提供给用户的结果和指示来执行计算。另外,特定阈值可能因单元而异。
图20示出了用于确定外部调节装置400的磁体440和可调节植入物200的永磁体262的失速状态的方法的示例性流程图,该方法包括以下步骤:旋转外部调节装置的磁体;在磁体的转动期间,对加速度阵列进行测量;确定加速度阵列的加速度峰值;将加速度阵列移位至中心峰值;对所捕获的所有加速度阵列求平均;从外部调节装置的特征化简档减去平均化阵列以获得测试阵列;执行测试阵列的快速傅立叶变换(FFT)分析;以及观测三次谐波,其中,如果满足以下项中的一个或更多个:三次谐波存在以及三次谐波高于阈值,则确定失速状态,并且其中,如果满足以下项中的一个或更多个:三次谐波不存在以及三次谐波低于阈值,则为检测到失速状态,并且磁体已耦合。
图21A至图21D示出了用于外部调节装置400的图形用户界面(GUI)的实施方式。可以将GUI显示在外部调节装置400的显示器403上。在外部调节装置400的操作期间,GUI允许用户向外部调节装置400输入指令、从外部调节装置400接收数据、或者以其它方式操作外部调节装置400。
图21A示出了LOCK(锁定)画面901,该LOCK画面901可以在外部调节装置400不活动时显示出来。在一些实施方式中,可以将外部调节装置400编程成在显示LOCK画面901的情况下锁定装置直到用户输入密码。在一些实施方式中,将外部调节装置400配置成,保持锁定直到外部调节装置400感测到它接近可调节植入物。
图21B示出了PATIENT SUMMARY(患者概况)画面902,该PATIENT SUMMARY画面传达个体患者调节信息。PATIENT SUMMARY画面902被示出为显示每日牵引量信息,以及患者的一个或更多个长骨骼的总牵引目标。
图21C示出了SESSION IN PROGRESS(疗程进度)画面903,该画面在外部调节装置的操作期间帮助引导用户。SESSION IN PROGRESS画面传达牵引信息,并且帮助防止可调节植入物的过度调节。GUI可以向用户传达进度测量、会话指令、已耦合状态指示以及失速状态指示中的一个或更多个。
图21D示出了允许用户选择多个治疗选项之一的RX SELECTION(RX选择)画面904。在一些实施方式中,无线通信组件提供基于云的数据采集和存储。如上文所讨论的,外部调节装置400可以包括无线连接能力,例如,wifi连接。wifi连接和联网功能允许第二用户远程访问外部调节装置以上传固件、下载调节数据、上传治疗选项或者远程操作装置。
本领域技术人员可以意识到,方法的这些示例性实施方式并非旨在详尽无遗。单独方法的框可以在各种实施方式之间进行替换和互换。可以将附加框添加和替换至与贯穿这些论文公开的附加步骤和特征相对应的各种实施方式。
现在,尽管为了使得本领域技术人员能够制造和使用所要求保护的发明而描述了特定的特征和实施方式,但是应理解,可以实现多种变化、更改或替换以达到所公开的主题。本说明书中的任何内容均不应被解释为限制在所附权利要求中阐述的本发明的精神和范围。
Claims (46)
1.一种对可调节植入物进行非侵入式调节的外部调节装置,所述外部调节装置包括:
壳体;
控制器,所述控制器和与所述可调节植入物关联的致动器进行通信;以及
电源。
2.根据权利要求1所述的外部调节装置,所述外部调节装置还包括传感器,所述传感器被配置成从所述可调节植入物接收信息或者接收有关所述可调节植入物的信息。
3.根据权利要求1所述的外部调节装置,所述外部调节装置还包括显示器。
4.根据权利要求1所述的外部调节装置,其中,所述控制器是可从所述外部调节装置移除的。
5.根据权利要求4所述的外部调节装置,其中,所述控制器是手持式电子装置。
6.一种对植入物进行非侵入式调节的外部调节装置,所述外部调节装置包括:
磁性部件,所述磁性部件被配置成生成旋转磁场;以及
驱动器,所述驱动器被配置成驱动所述磁性部件以生成旋转磁场,并且所述驱动器被配置成旋转可调节植入物的永磁体。
7.根据权利要求6所述的外部调节装置,所述磁性部件包括旋转磁体。
8.根据权利要求7所述的外部调节装置,所述磁性部件包括具有锥状外形的中空旋转磁体,所述中空旋转磁体被固定至具有锥状外形的磁体驱动轴。
9.根据权利要求8所述的外部调节装置,所述中空旋转磁体是通过盖帽固定至所述磁体驱动轴的。
10.根据权利要求6所述的外部调节装置,所述驱动器包括马达,所述马达被配置成旋转所述磁性部件以生成旋转磁场。
11.根据权利要求6所述的外部调节装置,所述外部调节装置还包括控制器。
12.根据权利要求11所述的外部调节装置,所述控制器被配置为可移除地连接至所述外部调节装置的壳体。
13.根据权利要求11所述的外部调节装置,所述控制器包括手持式电子装置。
14.根据权利要求6所述的外部调节装置,所述外部调节装置还包括储能装置。
15.根据权利要求14所述的外部调节装置,所述储能装置包括电池。
16.根据权利要求6所述的外部调节装置,所述外部调节装置还包括转速传感器,所述转速传感器被配置成,对所述驱动器的转速和所述磁性部件的转速中的一个或更多个进行监测。
17.根据权利要求16所述的外部调节装置,其中,将控制器配置成,确定以下项中的一个或更多个:所述可调节植入物的所述永磁体的磁耦合状态和失速状态。
18.根据权利要求17所述的外部调节装置,其中,所述确定是通过使用快速傅立叶变换FFT对加速度阵列进行变换来进行的。
19.根据权利要求18所述的外部调节装置,其中,所述确定是通过观测所述快速傅立叶变换FFT的三次谐波来进行的。
20.一种对植入物进行非侵入式调节的外部调节装置,所述外部调节装置包括:
控制器;
马达;以及
至少一个磁体,所述至少一个磁体被能旋转地联接至所述马达;
其中,在将所述外部调节装置放置得接近可调节植入物时,所述至少一个磁体被配置成,与所述可调节植入物的永磁体磁耦合;并且
其中,在所述至少一个磁体移动时,所述控制器被配置成,对所述至少一个磁体与所述可调节植入物的所述永磁体的磁耦合状态进行检测。
21.根据权利要求20所述的外部调节装置,其中,由所述控制器检测到的所述磁耦合状态是已耦合状态和未耦合状态中的一者。
22.根据权利要求20所述的外部调节装置,其中,所述控制器被配置成,确定所述马达的转速。
23.根据权利要求22所述的外部调节装置,其中,所述控制器使用所述转速,来确定所述至少一个磁体与所述可调节植入物的所述永磁体的所述耦合状态。
24.根据权利要求20所述的外部调节装置,其中,所述控制器被配置成,确定所述马达的加速度。
25.根据权利要求22所述的外部调节装置,其中,所述控制器使用所述马达的加速度,来确定所述至少一个磁体与所述可调节植入物的所述永磁体的失速状态。
26.根据权利要求25所述的外部调节装置,其中,所述确定是通过使用快速傅立叶变换FFT对加速度阵列进行变换来进行的。
27.根据权利要求18所述的外部调节装置,其中,所述确定是通过观测所述快速傅立叶变换FFT的三次谐波来进行的。
28.根据权利要求20所述的外部调节装置,其中,所述控制器被配置成,与所述马达无线通信并且控制所述马达。
29.根据权利要求20所述的外部调节装置,所述控制器包括智能手机。
30.根据权利要求20所述的外部调节装置,所述外部调节装置还包括储能装置。
31.根据权利要求30所述的外部调节装置,其中,所述储能装置是电池。
32.根据权利要求20所述的外部调节装置,所述外部调节装置包括存储器。
33.根据权利要求20所述的外部调节装置,所述外部调节装置包括显示器,所述显示器被配置成向用户传达信息。
34.根据权利要求33所述的外部调节装置,其中,向所述用户传达的所述信息包括:所述至少一个磁体与所述可调节植入物的所述永磁体的磁耦合状态。
35.根据权利要求33所述的外部调节装置,其中,向所述用户传达的所述信息包括以下项中的至少一个的变化量:所述可调节植入物的尺寸以及所述可调节植入物上的力。
36.根据权利要求33所述的外部调节装置,其中,向所述用户传达的所述信息包括以下项中的一个或更多个的转速:所述至少一个磁体以及所述可调节植入物的所述永磁体。
37.根据权利要求20所述的外部调节装置,其中,所述控制器被配置成,防止可植入医疗装置的尺寸变化超过预定限制。
38.一种对植入物进行非侵入式调节的外部调节装置,所述外部调节装置包括:
控制器;
马达;以及
至少一个磁体,所述至少一个磁体被能旋转地联接至所述马达;
其中,在将所述外部调节装置放置得接近可调节植入物时,所述至少一个磁体被配置成,与所述可调节植入物的永磁体磁耦合;并且
其中,在所述至少一个磁体移动时,所述控制器被配置成,确定所述至少一个磁体与被设置在所述可调节植入物内的磁体的磁耦合状态。
39.根据权利要求38所述的外部调节装置,其中,所述控制器对所述马达的转速进行监测。
40.根据权利要求38所述的外部调节装置,其中,所述控制器使用一个或更多个传感器来对所述至少一个磁体的转速进行监测。
41.根据权利要求40所述的外部调节装置,所述一个或更多个传感器包括磁传感器。
42.根据权利要求41所述的外部调节装置,所述磁传感器包括霍尔效应传感器。
43.一种对植入物进行调节的方法,所述方法包括以下步骤:
将外部调节装置定位得接近可调节植入物,
将所述外部调节装置的至少一个磁体与所述可调节植入物的永磁体进行耦合;
通过旋转所述外部调节装置的所述至少一个磁体来生成变化的磁场;
对所述外部调节装置的所述至少一个磁体的转速进行监测,以确定所述至少一个磁体与所述可调节植入物的所述永磁体的磁耦合状态。
44.一种用于获得外部调节装置的特征化简档的方法,所述方法包括以下步骤:
旋转所述外部调节装置的磁体;
在所述磁体的转动期间,对加速度阵列进行测量;
确定所述加速度阵列的加速度峰值;
将所述加速度阵列移位至中心峰值;以及
将平均化阵列保存为所述外部调节装置的特征化简档。
45.一种用于确定外部调节装置的磁体与可调节植入物的永磁体的已耦合状态的方法,所述方法包括以下步骤:
旋转所述外部调节装置的磁体;
在所述磁体的转动期间,对加速度阵列进行测量;
确定所述加速度阵列的加速度峰值;
将所述加速度阵列移位至中心峰值;
从所述外部调节装置的特征化简档减去平均化阵列,以获得测试阵列;以及
比较所述测试阵列的峰峰幅度与阈值,其中,如果所述测试阵列的峰峰幅度大于所述阈值,则确定已耦合状态,并且其中,如果所述测试阵列的峰峰幅度小于所述阈值,则确定未耦合状态。
46.一种使用外部调节装置来确定可调节植入物的永磁体的失速状态的方法,所述方法包括以下步骤:
旋转所述外部调节装置的磁体;
在所述磁体的转动期间,对加速度阵列进行测量;
确定所述加速度阵列的加速度峰值;
将所述加速度阵列移位至中心峰值;
从所述外部调节装置的特征化简档减去平均化阵列以获得测试阵列;
执行所述测试阵列的快速傅立叶变换FFT分析;以及
观测三次谐波,其中,如果满足以下项中的一个或更多个:三次谐波存在以及三次谐波高于阈值,则确定失速状态,并且
其中,如果满足以下项中的一个或更多个:三次谐波不存在以及三次谐波低于阈值,则为检测到失速状态,并且所述磁体已耦合。
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US20230181221A1 (en) | 2023-06-15 |
WO2020163800A1 (en) | 2020-08-13 |
JP7494195B2 (ja) | 2024-06-03 |
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