CN108079436A - 植体及其传送工具 - Google Patents

植体及其传送工具 Download PDF

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CN108079436A
CN108079436A CN201710347141.4A CN201710347141A CN108079436A CN 108079436 A CN108079436 A CN 108079436A CN 201710347141 A CN201710347141 A CN 201710347141A CN 108079436 A CN108079436 A CN 108079436A
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pin
equipment
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abrasion
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葛·奥伦
巴尔·伊坦
尼尔·阿蒙尼
艾伦·本杰明
吉姆丽·佩辛
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Qingfeng Medical Co Ltd
Bluewind Medical Ltd
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    • 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
    • A—HUMAN NECESSITIES
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    • A—HUMAN NECESSITIES
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/0551—Spinal or peripheral nerve electrodes
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A61N1/37205—Microstimulators, e.g. implantable through a cannula
    • A—HUMAN NECESSITIES
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    • 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
    • A61N1/37211—Means for communicating with stimulators
    • A61N1/37217—Means for communicating with stimulators characterised by the communication link, e.g. acoustic or tactile
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips

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Abstract

一种使用于包含一天线的一植体的一设备，所述设备包含一传送工具，所述传送工具包含一中空的针，所述针界定位在所述针的一壁中的多个侧面开口。所述中空的针是被配置以容纳所述植体。所述传送工具被配置以界定一第一状态、一第二状态及一第三状态。于所述第一状态中，所述植体被所述针容纳以致使所述天线被设置于在所述多个侧面开口的近侧。于所述第二状态中，所述植体的一远端部分从所述针的一远端被暴露，且所述天线对准于所述多个侧面开口。于所述第三状态中，所述植体整个被设置在所述针的所述远端的外面。

Description

植体及其传送工具
技术领域
本发明是有关于多个医疗器材，特别是有关于用于多个经皮植体的多个设备及多个方法。
背景技术
多种神经系统疾病影响多条神经、多条肌肉或大脑。许多的神经系统疾病减少或消除多条肌肉的随意募集，而可造成失去进行多个运动任务的能力或维持多个为它们的功能依靠肌肉活动的系统的能力。其他多种疾病可导致相邻组织疼痛。
神经刺激为一种临床工具，所述临床工具用以治疗各种神经系统疾病，且通过活化在身体内的多条纤维，牵涉神经系统的调节。
发明内容
对于本发明的一些应用而言，一系统被提供，所述系统包含一植体以及其传送工具。所述植体具有一天线及至少一电极。所述传送工具包含一中空的针，所述中空的针一般具有多个侧面的开口。所述传送工具具有分立的多个状态。一般而言，于一第一状态中，所述植体为整个被容纳于所述针中，及/或所述天线被设置于位在所述针中的所述多个侧面开口的近侧。一般而言，于一第二状态中，所述植体的一远端部分从所述针的一远端被暴露，及/或所述天线对准于所述多个侧面开口。于所述第三状态中，所述植体整个被设置于所述针的所述远端的外面。所述系统：(i)促进用于所述植体的多个可能的植入位置的测试，以及(ii)增加朝靠近神经组织推进多个植体的安全性。
对于本发明的一些应用而言，所述针在其一远端处界定一个三重研磨斜角，所述三重研磨斜角界定：(i)一个主要研磨部分，以及(ii)两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。此三重研磨斜角可被用于本文中所叙述的所述传送工具的所述针以外的多根针。
对于本发明的一些应用而言，所述植体界定一凹入部分，一套管绕所述凹入部分设置，所述套管促进锚固所述植体。
因此，依据本发明一应用提供一种用于促进经皮传送一植体至一受试者的一身体的一目标位置的设备，所述植体包含一天线，及所述设备包含︰
一传送工具，包含一中空的针，所述针界定位在所述针的一壁中的多个侧面开口，所述中空的针被配置以容纳所述植体，
所述传送工具被配置以界定：
一第一状态，于所述第一状态中，所述植体被所述针容纳以致使所述天线被设置在所述多个侧面开口的近侧；
一第二状态，于所述第二状态中，所述植体的一远端部分从所述针的一远端被暴露，且所述天线对准于所述多个侧面开口；以及
一第三状态，于所述第三状态中，所述植体整个被设置于所述针的所述远端的外面。
于一应用中，于所述第一状态中，整个所述植体被设置于所述针中。
于一应用中，于所述第一状态中，整个所述植体被设置在所述多个侧面开口的近侧。
于一应用中，于所述第一状态中，所述植体的所述远端部分对准于所述多个侧面开口。
于一应用中，所述中空的针为一中空的金属针。
于一应用中，所述中空的针界定一个三重研磨斜角在所述针的所述远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
于一应用中，所述设备还包括所述植体。
于一应用中:
所述植体为一电刺激植体，且包括：
一植体主体，所述植体沿所述植体主体的一纵轴为可注射入该受试者的组织中；
一近端电极以及一远端电极，设置在所述植体主体上，所述远端电极被设置在所述近端电极的远侧，以及
于所述传送工具的所述第二状态中，所述远端电极从所述针的所述远端被暴露。
于一应用中，于所述传送工具的所述第一状态中，所述近端电极与所述远端电极被设置在所述针内。
于一应用中，所述天线被配置以无线接收能量。
依据本发明一应用还提供一种用于经皮传送一植体至一受试者的一身体的一目标位置的方法，所述方法包含：
当一传送工具于一第一状态中时，将所述传送工具的一中空的针插入所述受试者的组织，于所述第一状态中，所述植体整个被容纳于所述针中，且所述植体的任何部分均没有经由位于一针壁中的多个侧面开口被暴露；
接续地，将所述传送工具转换至一第二状态，于所述第二状态中，所述植体的一远端部分从所述针的一远端被暴露，及所述植体的一近端部分至少部分经由所述针壁所界定的所述多个侧面开口被暴露；以及
接续地，将所述传送工具转换至一第三状态，于所述第三状态中，所述植体整个被设置于所述针的所述远端的外面。
于一应用中，所述方法还包括，当所述传送工具于所述第二状态中时，在所述受试者的所述身体内朝远侧推进所述传送工具及所述植体。
依据本发明一应用还提供一种用于经皮传送一植体通过一受试者的一身体的一区域至所述身体的一目标位置的方法，所述区域包括一筋膜与非筋膜组织，所述方法包括：
当一传送工具为于一第一状态中时，将所述传送工具的一中空的针朝远侧通过所述筋膜推进，于所述第一状态中，所述植体整个被容纳于所述针中；
将所述传送工具转换至一第二状态，于所述第二状态中，所述植体的一近端部分被容纳于所述针中，及所述植体的一远端部分从所述针的一远端被暴露；当所述传送工具为于所述第二状态中时，将所述中空的针朝远侧通过所述非筋膜组织。
于一应用中，所述方法还包括，于朝远侧通过所述筋膜推进所述中空的针之前，将所述传送工具转换至所述第一状态。
于一应用中，所述方法还包括，于将所述传送工具转换至所述第一状态之前，当所述工具于所述第二状态中时，朝远侧通过所述非筋膜组织而往所述筋膜推进所述中空的针。
于一应用中，所述方法还包括，接续当所述工具于所述第二状态中时，朝远侧通过所述非筋膜组织推进所述中空的针的步骤之后，将所述传送工具转换至一第三状态，于所述第三状态中，所述植体被整个设置于所述针的所述远端外面。
于一应用中，所述方法还包括，当所述传送工具于所述第三状态中时，从所述传送工具释放所述植体。
依据本发明一应用还提供一种用于促进经皮传送一植体至一受试者的一身体的一目标位置的设备，所述设备包含︰
一针，包含：
一远端；及
一近端，
所述针界定：
一管腔，被配置以促进所述植体于其中通过，以及
一个三重研磨斜角，位在所述针的所述远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
于一应用中，所述针界定位在所述针的一壁中的多个侧面开口，所述多个侧面开口位在所述针的所述远端的近侧。
于一应用中，所述针为一金属针。
于一应用中，所述两个侧研磨部分彼此以65至85度的一角度在远侧会合。
于一应用中，所述主要研磨部分相对于所述针的一中心纵轴界定15至25度的一角度。
于一应用中，所述两个侧研磨部分在远侧会合，但在所述针的一最远端部分处，所述两个侧研磨部分为以0.1至0.4毫米隔开。
依据本发明一应用还提供一种用于经皮传送一植体至一受试者的一身体的一目标位置的方法，所述方法包含：
将所述植体插入所述受试者的组织；
将所述植体启动以便以一第一功率水平在所述组织内的一第一位置处对所述受试者的组织施加一电流；
测量对以所述第一功率水平对所述第一位置施加所述电流的所述受试者的一回应；
相应于侦测到所述受试者对以所述第一功率水平对所述第一位置施加所述电流以一给定的方式回应，以多个迭代下降的功率水平对所述第一位置迭代施加多个电流直到侦测到所述受试者对以一第二功率水平对所述第一位置施加一电流不以所述给定的方式回应；以及
接续地：
在所述受试者的组织内将所述植体移动至一或多进一步位置，且以所述第二功率水平在所述一或多进一步位置处对所述组织施加一电流；
测量在所述一或多进一步位置处对所述受试者的组织施加所述电流的所述受试者的一回应；以及
相应于侦测到所述受试者对以所述第二功率水平在一给定的一或多进一步位置的其中之一处施加所述电流以所述给定的方式回应，将所述植体植入在较近于所述给定位置而较远于所述第一位置之处。
于一应用中：
将所述植体插入包括当所述植体至少部分被设置于一传送工具的一中空的针内时，将所述植体插入，
将所述植体移动包括当所述植体至少部分被设置于所述中空的针内时，将所述植体移动，以及
将所述植体启动包括当(i)所述植体至少部分被设置于所述中空的针内时，且(ii)当所述植体的一电极从所述中空的针的一远端被暴露时，将所述植体启动。
于一应用中，将所述植体启动包括当所述植体的一天线对准于位于所述中空的针的一壁中的一侧面开口时，将所述植体无线启动。
于一应用中，将所述植体移动包括当所述植体的所述电极仍是从所述中空的针的所述远端被暴露时，将所述植体移动。
依据本发明一应用还提供一种设备，所述设备包含：
一植体，被配置以被植入一受试者的组织中，所述植体包括：
一植体主体，包括：
所述植体主体的至少一第一纵向部分，以界定一给定的外径；
所述植体主体的一凹入纵向部分，相对于所述植体主体的所述第一纵向部分呈径向凹入，以致使所述凹入纵向部分的一外径较小于所述第一纵向部分的所述外径；以及
一套管，绕着所述植体主体的所述凹入纵向部分而与所述植体主体耦接，以致使所述套管的一外径不超过所述第一纵向部分的所述外径，其中所述套管界定多个孔洞，所述多个孔洞被配置以通过促进组织长入所述多个孔洞而促进相对于所述受试者的组织锚固所述植体主体。
于一应用中，所述套管绕所述凹入纵向部分延伸少于360度。
于一应用中，所述多个孔洞的每一孔洞具有200至550微米的一直径。
于一应用中，所述套管具有200至550微米的一厚度。
于一应用中，所述植体还包括一天线，所述天线设置于所述凹入纵向部分内。
于一应用中，所述凹入纵向部分不包括所述植体的一远端或一近端。
于一应用中，所述套管包含一弹性材料。
于一应用中，所述设备还包含一传送工具，所述传送工具包括一中空的针，所述植体可滑动的通过所述针，其中所述套管的所述外径使得所述套管不致抓住所述中空的针的内部。
于一应用中，所述中空的针界定一个三重研磨斜角在所述针的一远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
本发明将由以下其多个应用的详细说明，配合附图，被更完整地了解，其中：
附图说明
图1A至1C是依据本发明的一些应用的一系统的多个示意图，所述系统包含一植体及其传送工具。
图2A至2H是依据本发明的一些应用的一技术手段的多个示意图，所述技术手段用于使用所述传送工具植入所述植体。
图3A至3D是依据本发明的一些应用的所述传送工具的一针的一尖的多个示意图。
图4A至4C是依据本发明的一些应用的所述植体的多个示意图。
具体实施方式
参照图1A至1C、2A至2H、3A至3D及4A至4C，其为依据本发明的一些应用的一系统20及用于使用所述系统的多个技术手段的多个示意图。一系统20包含一植体40，以及用于经皮植入所述植体的一传送工具100。
所述植体40包含一植体主体42，被设置在所述植体主体42内的一电路44及一天线46，以及被设置在所述植体主体42外的至少一电极48(例如，一近侧电极48p以及一远侧电极48d)。所述植体40具有一近端部分50p(例如，一近端半)及一远端部分50d(例如，一远端半)，所述近端部分50p包括所述植体40的一近端，所述远端部分50d包括所述植体40的一远端。一般而言，所述多个电极48的至少其中之一(例如，一远侧电极48d)被设置在所述远端部分50d处。一般而言，所述天线46被设置在所述至少一电极48的近侧。举例而言，所述天线46可被设置在所述远端部分50d的近侧，如是所述近端部分50p内。
在所述植体40的所述近端部分50p处(例如，在所述近端处)，所述植体40(例如，所述植体主体42)界定一植体耦接部52，所述植体耦接部52可逆地可耦接于所述工具100的一互补的工具耦接部。
所述工具100包含位在所述工具的一远端部分处的一中空的针102，及位在所述工具的一近端部分处的一控制部分104，所述控制部分一般包含一柄106。所述针102具有一侧面的壁，所述侧面的壁形成所述针的一纵轴ax1的周围以便界定沿所述纵轴的一管腔。所述针102界定位在所述侧面的壁中的多个侧面开口108(例如，多个纵向狭缝)。所述工具100被配置以界定至少三个状态，所述三个状态被分别示于图1A至1C。
图1A至1C显示所述植体40被装载于所述工具100中。于所述第一状态中(图1A)，所述植体40被所述针102容纳以致使所述天线46被设置在所述多个开口108的近侧。对于一些应用而言，于所述第一状态中，整个所述植体40被设置于所述多个开口108的近侧(即沿所述针102的所述纵轴ax1的近侧)。或者，且如图所示，所述植体40的其中一部份(例如，远端部分50d)对准于所述多个开口108(例如，被设置在所述针102的所述纵轴ax1的相同部分处)，及/或在所述多个开口108的远侧(例如，沿所述针102的所述纵轴ax1的远侧)。一般而言，且如图所示，于所述第一状态中，所有的多个所述电极48被设置在所述针102内(例如，其所述管腔)。举例而言，且如图所示，于所述第一状态中，所述植体40可被整个设置于所述针102内。
于所述第二状态中(图1B)，所述植体40的所述远端部分50d从所述针102的所述远端被暴露，且所述天线46对准于所述多个开口108(例如，被设置在所述针102的所述纵轴ax1的相同部分处)。一般而言，于所述第二状态中，所述电极48d从所述针102的所述远端被暴露。
于所述第三状态中(图1C)，所述植体40整个被设置于所述针102的所述远端的外面。
所述植体40为一电刺激植体，且驱动所述多个电极48以便对在其内植入所述植体40的所述受试者的组织施加一电流。通过从一体外的控制器(未图示)传输多个无线信号，所述植体40被控制且/或被无线供电。如此之多个信号被所述天线46接收。所述针102一般为金属的。所述多个开口108允许如此之多个无线信号被通过而进入所述针102的所述管腔内。所述针102的其他多个部分为对如此之多个信号相对不透明。当植入所述植体40时，且于所述植体40被最后部属(即被释放)之前，所述植体40被启动以致使为决定是否所述组织内的当前地点是用于植入所述植体40的一有效地点(例如，通过决定是否对所述受试者的所需效果出现)，所述植体40驱动所述多个电极48以对所述组织施加所述电流。多位发明人假定避免操作者(例如，医师)不适当地及/或不慎地启动所述植体40(例如，在一不适当的时间点)为有利的。于所述第一状态中，所述多个无线信号不能抵达(或不能充分地抵达)所述天线46。因此，于所述第一状态中，不能进行测试所述植体40的位置。于所述第二状态中，所述多个无线信号能抵达所述天线46，因此，于所述第二状态中，测试所述植体40的位置为可能。(自然地，因为于所述第三状态中时，所述植体40整个被设置于所述针102的所述远端外面，当所述工具100为于所述第三状态中时，所述多个无线信号亦能抵达所述天线46)
对于多个应用而言，使用所述多个开口108为特别有用，于所述多个应用中，形成所述针102的材料对所述多个无线信号为不透明(例如，一金属)。对于一些应用而言，主要形成所述针102的材料可为对所述多个无线信号为透明(例如，聚合物)。对于一些应用而言，所述针102可具有一金属部分(例如，所述聚合物径向往内、径向往外及之内的一金属壳，或一不同的金属纵向区段，所述不同的金属纵向区段位在于其近侧及于其远侧的聚合物纵向区段之间)，所述金属部分位在所述针的一部分处，所述针的所述部分处为于所述工具100的所述第一状态中，所述天线46被设置之处。如上文所述，经适当地修改，所述金属部分抑制所述无线信号抵达(或充分地抵达)所述天线46。因此，相似于上文所述，如此的针会避免所述工具100于所述第一状态中不适当地/不慎地启动所述植体40，但会允许所述工具100于所述第二状态中启动所述植体40。相似地，对于一些应用而言，所述针102可主要被由一金属形成，但所述多个开口108被所述针的一聚合物部分所取代。
以上所述的多个实施例具有以下多个相通之处：
所述中空的针具有：(i)一非阻挡纵向部分，当所述天线被设置于所述非阻挡纵向部分中时，所述非阻挡纵向部分允许所述无线信号抵达所述天线，以及(ii)一阻挡纵向部分，所述阻挡纵向部分显着地较所述非阻挡纵向部分对所述无线信号为不透明，以致使当所述天线被设置于所述阻挡部分中时，所述阻挡纵向部分阻挡所述无线信号启动所述植体。
·于所述工具的所述第一状态中，所述天线被设置于所述针的所述阻挡部分中。
·于所述工具的所述第二状态中，所述天线被设置于所述针的所述非阻挡部分中。
·于所述工具的所述第三状态中，所述植体整个被设置于所述针的所述远端的外面。
·一般而言，所述非阻挡部分较近于所述针的所述远端而所述阻挡部分较远于所述针的所述远端。
对于一些应用而言，于所述多个应用中，(i)于所述第一状态中，所有的多个电极48被设置于所述针102内，以及(ii)于所述第二状态中，所述电极48d从所述针的所述远端被暴露。分别于第一及第二状态中的所述多个电极的不同位置还可避免不适当地及/或不慎地由植体40驱动所述电流。亦即，于所述第一状态中，所述植体40不能接收所述多个无线信号，且所述多个电极48没有为施加一电流被暴露，然而，于所述第二状态中，所述植体40能接收所述多个无线信号，且所述多个电极48至少其中之一为施加所述电流被暴露。
应注意的是，于所述工具100的所述第一、第二及第三状态的上下文中，「状态」的用语(包括在说明书及权利要求中)意指所述工具的一分立且预先被配置的状况，如所述工具被配置以停留于其中的状况。故而，所述工具100被配置以界定所述多个状态意指所述工具100具有多个特定的特征或元件，所述多个特定的特征或元件界定所述多个状态及/或使所述工具保持在所述多个状态中。举例而言，所述工具100(例如，所述控制部分104)可包含多个控制元件110，所述多个控制元件110使转换于所述多个状态之间为可行。
图2A至2H显示一技术手段的多个步骤，依据本发明的一些应用，所述技术手段为用于使用所述传送工具100植入所述植体40。所使用的举例为将所述植体40靠近所述受试者的一胫神经6植入，且以一远端至近端方向，但经适当地修改，所述技术手段可使用在多个其他解剖位置，及/或以多个其他解剖方向。图2A至2H之每一显示一受试者的一小腿4的一纵向剖面及一横向剖面。所述纵向剖面绘示将所述针102推进通过所述组织，以及所述工具100的所述状态。所述横向剖面提供更多的解剖细节，且示意地显示所述针102所穿刺至的深度。于所述横向剖面中，被标示为102的元件示意地代表所述针102。然而，虽然于所述横向剖面中所述针102应延伸入及/或出一页面，为清楚起见，一较简单的代表被使用。
所述针102(例如，其一尖120)被经皮推进入所述脚(图2A)。对于一些应用而言，且如图所示，当所述工具100于所述第一状态中时，所述针102被推进通过皮肤，故以所述尖120界定所述系统20的一前缘，例如，以致使所述针102穿刺所述皮肤。(或者，于皮肤内形成一切口，且例如于所述第二状态中，所述工具100经过所述切口被引入)。接续地，所述工具100被转换至所述第二状态(图2B)。接续地，当所述工具100于所述第二状态中时，所述工具100被推进通过所述脚的非筋膜组织(例如，脂肪组织，及/或结缔组织)8，一般直到抵达一筋膜10(图2C)。亦即，所述系统20以所述植体40于所述针102的远端且界定所述系统20的前缘而被推进通过所述非筋膜组织。在抵达一筋膜10时，所述工具100被转换至所述第一状态(图2D)，且当于所述第一状态中时(图2E)被推进通过所述筋膜。一旦通过所述筋膜，所述工具100被转换至所述第二状态(图2F)，且被推进通过更多组织8(图2G)。如上文所述，于所述第二状态中，决定是否所述组织内的当前地点是用于植入所述植体40的一有效地点为可能。一旦达到所述植体40的一适当地点(图2G)，所述工具100被转换至所述第三状态(图2H)。自动地在所述工具100被转换至所述第三状态时，或作为一不同的后续部属步骤的结果，所述植体40被部属(例如，从所述工具100被释放)在一适当地点。
如上文所述，通过启动所述植体40，及例如侦测是否对受试者植体的所需效果出现，决定所述植体40为位于用于植入的一适当地点被达成。所述多位发明人假设对于一些应用而言，当所述植体被启动而以一单一功率水平施加一电流，如此之一技术手段可被限制。举例而言，当一单一功率水平被使用，如果当所述植体在一第一位置处时对所述受试者的一效果被侦测到，及当所述植体在一第二位置处时对所述受试者的一效果亦被侦测到，所述技术手段将不会提供所述二位置其中何者较为合适(例如，较靠近神经6)的资讯。所述多位发明人假设通过变化所述功率水平，如此之一技术手段可被改进，所述植体40以所述功率水平对所述植体设置于其内的所述组织施加一电流。举例而言，如果(1)当所述植体在所述第一位置处时所述效果被侦测到之后，所述植体再一次被启动，但使用多个迭代下降的功率水平直到所述效果被减少(例如，至低于一临界水平，如直到所述效果没有被侦测到)，及(2)当所述下降的功率水平被使用在所述第二位置处，所述效果被侦测到(及/或为高于所述临界水平)，此表示所述第二位置较所述第一位置为适当(例如，较靠近所述神经6)。
因此，提供一种用于经皮传送一植体至一受试者的一身体的一目标位置的方法，所述方法包含：
(1)将所述植体插入所述受试者的组织；
(2)将所述植体启动以便以一第一功率水平在所述组织内的一第一位置处对所述受试者的组织施加一电流；
(3)测量对以所述第一功率水平对所述第一位置施加所述电流的所述受试者的一回应；
(4)相应于侦测到所述受试者对以所述第一功率水平对所述第一位置施加所述电流以一给定的方式回应，以多个迭代下降的功率水平对所述第一位置迭代施加多个电流直到侦测到所述受试者对以一第二功率水平对所述第一位置施加一电流不以所述给定的方式回应；以及
(5)接续地：
(a)在所述受试者的组织内将所述植体移动至一或多进一步位置，且以所述第二功率水平在所述一或多进一步位置处对所述组织施加一电流；
(b)测量在所述一或多进一步位置处对所述受试者的组织施加所述电流的所述受试者的一回应；以及
(c)相应于侦测到所述受试者对以所述第二功率水平在一给定的一或多进一步位置的其中之一处施加所述电流以所述给定的方式回应，将所述植体植入在较近于所述给定的位置而较远于所述第一位置之处。
对于在所述多个位置之间所述植体的移动不需要进一步穿刺一筋膜的多个应用而言，此在所述多个位置之间所述植体的移动一般为当所述传送工具停留于所述第二状态中时进行。
所述尖120为用于穿刺组织的一削角尖。所述多位发明人假定多个削角尖对于穿刺所述筋膜10(及一般亦皮肤12)为重要，但一些其他组织(例如，脂肪组织，及/或结缔组织)能被所述植体40本身穿刺。故而，于如图2A至H所示的所述技术手段中，当所述工具100于所述第二状态中时，所述植体40被推进通过所述组织8，故(如上文所述)促进辨识用于植入所述植体40的一有效地点。所述多位发明人更假定当所述植体40变得靠近一目标神经如胫神经6时，将所述植体在所述工具100为于所述第二状态中时推进减少以所述尖120伤害所述神经或邻近血管的可能性。
应注意的是，所述工具100的多个状态之间的所述工具100的转变为通过相对于所述控制部分104缩回及推进所述针102(例如，改变所述针的一有效长度)，而非通过推进及缩回所述植体40。此允许一旦一适当地点被辨识出，所述植体40在其不相对于周围组织移动的情况下从所述工具100被部属(图2G至2H)。
图3A至3D显示依据本发明的一些应用的所述传送工具100的所述针102的所述尖120的多个细部视图。所述尖120具有一个三重研磨斜角，所述三重研磨斜角界定一个主要研磨部分122(或者称作一个主要斜角)及两个侧研磨部分124(或者称作两个次要斜角，或柳叶刀的双刃)。与多个其他三重研磨斜角不同的是，所述两个侧研磨部分124不延伸以彼此交会而界定位在所述针的一最远端部分处(例如，在所述针的一尖)的一点(例如，一远端点)。亦即，所述主要研磨部分122对于所述尖120的所述最远端部分126的有尖头性有贡献，但所述两个侧研磨部分124没有。故而，当所述尖120被从侧面观看时(例如，当所述尖120被观看以致使所述主要研磨部分122形成所述尖的一部分轮廓线)(例如，图3A视图D)，所述部分126显得有尖头，但当所述尖120被从上方或下方观看时(例如，当所述尖120被观看以致使所述两个侧研磨部分124均为可见的)(例如，图3A视图C及视图F，及图3B)，所述部分126显得为钝的或弧状的。因此，所述两个侧研磨部分124朝所述最远端部分126会合，但即便在它们最靠近彼此的地方(例如，在所述部分126处或接近所述部分126)，它们以一距离d5隔开。
对于一些应用而言，所述主要研磨部分122相对于所述针102的所述侧面的壁及/或所述中心纵轴ax1界定15至25度(例如，18至22度，如20度)的一角度。对于一些应用而言，所述两个侧研磨部分124彼此以65至85度(例如，74至78度，如76度)的一角度α1在远侧会合(见图3B)。对于一些应用而言，所述距离d5为0.1至0.4毫米(例如，0.16至0.28毫米，如0.22毫米)。
图3C显示依据本发明的一些应用的剖于剖面III(示于图3B)的所述尖120的一横向剖面图。对于此应用而言，所述两个侧研磨部分124背向所述主要研磨部分122。亦即，所述两个侧研磨部分124在所述针「以下」，而不消除所述主要研磨部分122的一斜面。因此，所述主要研磨部分122的所述面于图3C中为可见的。于所述横向剖面图中，所述两个侧研磨部分124的两个平面相对于彼此以一角度α2被设置，所述角度α2一般为100至150度(例如，110至140度，例如120至140度，如130度)。对于一些应用而言，此相似于一「背斜角尖」针尖，但所述两个侧研磨部分124不延伸以便彼此交会而界定位在所述针的所述最远端部分处的一点。因此，所述角度α2可被称为一背斜角角度。
图3D显示依据本发明的一些其他应用的所述尖120的一横向剖面图。对于此应用而言，两个侧研磨部分124’面朝所述主要研磨部分122。亦即，所述两个侧研磨部分124’在于与所述主要研磨部分122相同的所述针的一边，且在所述两个侧研磨部分124’被设置于其的所述针的纵向部分，所述两个侧研磨部分124’消除所述主要研磨部分122的所述斜面，而留下一脊125。于所述横向剖面图中，所述两个侧研磨部分124’的所述两个平面相对于彼此以一角度α3被设置。对于一些应用而言，此相似于一「柳叶刀尖」针尖，但所述两个侧研磨部分124’不延伸以便彼此交会而界定位在所述针的所述最远端部分处的一点。因此，所述角度α3可被称为一柳叶刀角度。
因此，依据本发明的一些应用提供一种用于促进经皮传送一植体至一受试者的一身体的一目标位置的设备，所述设备包含一针，所述针：(1)包含：(a)一远端；及(b)一近端；及(2)界定：(a)一管腔，被配置以促进所述植体于其中通过；以及(b)一个三重研磨斜角，位在所述针的所述远端处，所述三重研磨斜角界定：(i)一个主要研磨部分，以及(ii)两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
所述多位发明人假定所述针120有利地具有以下两者：(i)多个现有三重研磨针的多个穿刺组织优点，以及(ii)一最远端部分，所述最远端部分为相对弧状的，及相较于如此之多个现有三重研磨针，为较不可能伤害一目标神经或一邻近血管。
图4A至4C显示所述植体40多个分别的视图。图4A显示所述植体40整体。如上文所述，所述电路44及所述天线46被设置在所述植体主体42内，且所述至少一电极48被设置于所述植体主体42外。亦如上文所述，所述多个电极48至少其中之一(例如，所述远侧电极48d)被设置在所述远端部分50d处。一般而言，另一电极(例如，所述近侧电极48p)被设置在所述近端部分50p处。所述天线46一般被设置在所述电极48d的近侧(例如，于所述近端部分50p内)。
所述植体包含一套管(cuff)54，所述套管54形成所述植体主体42的一凹入纵向部分56的周围。图4B绘示所述套管54被移除的所述植体40，故显示所述凹入纵向部分56。于所显示的范例中，所述凹入纵向部分56由所述近端部分50p的至少一部分被界定。然而，所述凹入纵向部分56可依其他的方式或另外的方式以所述远端部分50d的至少一部分被界定。
所述凹入纵向部分56相对于所述植体主体42的至少另一纵向部分呈径向凹入，以致使所述凹入纵向部分的一外径较小于所述另一纵向部分的一外径。于所显示的范例中，所述另一纵向部分可为一纵向部分58，所述纵向部分58位在所述部分56的近侧(例如，所述近端部分50p的另一部分)，或可为一纵向部分60，所述纵向部分60位在所述部分56的远侧(例如，所述远端部分50d的一部分)。举例而言，所述凹入纵向部分56的一外径d3较小于所述部分58的一外径d4，及亦较小于所述部分60的一外径(所述部分60的所述外径可与所述外径d4相同)，且因此不包括所述植体40的所述远端或所述近端。
所述套管54通过被耦接于(例如，围绕)所述凹入纵向部分56被配置被耦接于所述植体主体42以致使当所述套管54被耦接于所述部分56时，所述套管54的一外径d1不超过所述外径d4。对于一些应用而言，所述套管54绕所述植体主体42延伸少于360度(例如，340至355度)。一般而言，所述套管54具有100至500微米(例如200至250微米，如225微米)的一厚度。
所述套管54界定多个孔洞62，每一孔洞62可具有200至550微米(例如，280至340微米)的一直径。所述套管54一般包含一弹性材料。对于一些应用而言，所述套管54包含聚醚醚酮、聚乙烯对苯二甲酸酯、氟化乙烯丙烯、聚酰亚胺、丙烯酸、尼龙、聚四氟乙烯，或聚醚酰亚胺(例如，耐高温复合材料(Ultem))。此材料及/或所述多个孔洞62增加所述套管54的阻力，且因此一旦所述植体40被植入于组织中，增加植体40对移动的阻力(例如，所述套管54抓住所述组织)。亦即，所述套管54作为一锚。因为所述外径d1不超过所述外径d4，所述套管54不抓住所述针102的内部(亦即，不增加对于所述针的所述内部所述植体的摩擦力)，故在传送及部属所述植体40时，不干扰所述植体40在所述针102内的移动。所述多个孔洞62还被配置以通过促进组织长入所述多个孔洞62而促进相对于所述组织锚固所述植体40。
图4C显示所述多个电极48及所述植体主体42的其中大部分被移除的所述植体40，故显示所述天线46及所述电路44。对于一些应用而言，且如图所示，所述天线46被设置于所述凹入纵向部分56内。
应注意的是，对于一些应用而言，所述工具100可被使用以传送所述植体40以外的多个植体。举例而言，所述工具100可被使用以传送一不同的电刺激植体，或是非为一电刺激植体的一植体。还应注意的是，对于一些应用而言，所述针102(例如，其所述尖120)可被使用于所述工具100以外的多个传送工具。还应注意的是，所述针102可对于经皮植入一植体以外的多个应用为有用。
本领域的技术人员将理解本发明不限于上文特地显示及叙述的内容。更准确的说，本发明的范围包括上文所述的各种特征的多个组合及多个子组合两者，及其不在现有技术中的多个变化及多个修改，所述多个变化及所述多个修改在本领域的技术人员阅读以上说明时会被想到。

Claims (25)

1.一种用于促进经皮传送一植体至一受试者的一身体的一目标位置的设备，所述植体包含一天线，其特征在于：所述设备包含︰
一传送工具，包含一中空的针，所述针界定位在所述针的一壁中的多个侧面开口，所述中空的针被配置以容纳所述植体，
所述传送工具被配置以界定：
一第一状态，于所述第一状态中，所述植体被所述针容纳以致使所述天线被设置在所述多个侧面开口的近侧；
一第二状态，于所述第二状态中，所述植体的一远端部分从所述针的一远端被暴露，且所述天线对准于所述多个侧面开口；以及
一第三状态，于所述第三状态中，所述植体整个被设置于所述针的所述远端的外面。
2.如权利要求1所述的设备，其特征在于：于所述第一状态中，整个所述植体被设置于所述针中。
3.如权利要求1所述的设备，其特征在于：于所述第一状态中，整个所述植体被设置在所述多个侧面开口的近侧。
4.如权利要求1所述的设备，其特征在于：于所述第一状态中，所述植体的所述远端部分对准于所述多个侧面开口。
5.如权利要求1所述的设备，其特征在于：所述中空的针为一中空的金属针。
6.如权利要求1所述的设备，其特征在于：所述中空的针界定一个三重研磨斜角在所述针的所述远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
7.如权利要求1至6任一项所述的设备，其特征在于：所述设备还包含所述植体。
8.如权利要求7所述的设备，其特征在于：
所述植体为一电刺激植体，且包含：
一植体主体，所述植体沿所述植体主体的一纵轴为可注射入该受试者的组织中；
一近端电极以及一远端电极，设置在所述植体主体上，所述远端电极被设置在所述近端电极的远侧，以及
于所述传送工具的所述第二状态中，所述远端电极从所述针的所述远端被暴露。
9.如权利要求7所述的设备，其特征在于：于所述传送工具的所述第一状态中，所述近端电极与所述远端电极被设置在所述针内。
10.如权利要求7所述的设备，其特征在于：所述天线被配置以无线接收能量。
11.一种用于促进经皮传送一植体至一受试者的一身体的一目标位置的设备，其特征在于：所述设备包含︰
一针，包含：
一远端；及
一近端，
所述针界定：
一管腔，被配置以促进所述植体于其中通过，以及
一个三重研磨斜角，位在所述针的所述远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
12.如权利要求11所述的设备，其特征在于：所述针界定位在所述针的一壁中的多个侧面开口，所述多个侧面开口位在所述针的所述远端的近侧。
13.如权利要求11所述的设备，其特征在于：所述针为一金属针。
14.如权利要求11所述的设备，其特征在于：所述两个侧研磨部分彼此以65至85度的一角度在远侧会合。
15.如权利要求11所述的设备，其特征在于：所述主要研磨部分相对于所述针的一中心纵轴界定15至25度的一角度。
16.如权利要求11至15任一项所述的设备，其特征在于：所述两个侧研磨部分在远侧会合，但在所述针的一最远端部分处，所述两个侧研磨部分为以0.1至0.4毫米隔开。
17.一种设备，其特征在于，所述设备包含：
一植体，被配置以被植入一受试者的组织中，所述植体包含：
一植体主体，包含：
所述植体主体的至少一第一纵向部分，以界定一给定的外径；
所述植体主体的一凹入纵向部分，相对于所述植体主体的所述第一纵向部分呈径向凹入，以致使所述凹入纵向部分的一外径较小于所述第一纵向部分的所述外径；以及
一套管，绕着所述植体主体的所述凹入纵向部分而与所述植体主体耦接，以致使所述套管的一外径不超过所述第一纵向部分的所述外径，
其中所述套管界定多个孔洞，所述多个孔洞被配置以通过促进组织长入所述多个孔洞而促进相对于所述受试者的组织锚固所述植体主体。
18.如权利要求17所述的设备，其特征在于：所述套管绕所述凹入纵向部分延伸少于360度。
19.如权利要求17所述的设备，其特征在于：所述多个孔洞的每一孔洞具有200至550微米的一直径。
20.如权利要求17所述的设备，其特征在于：所述套管具有200至550微米的一厚度。
21.如权利要求17所述的设备，其特征在于：所述植体还包含一天线，所述天线设置于所述凹入纵向部分内。
22.如权利要求17所述的设备，其特征在于：所述凹入纵向部分不包括所述植体的一远端或一近端。
23.如权利要求17所述的设备，其特征在于：所述套管包含一弹性材料。
24.如权利要求17至23任一项所述的设备，其特征在于：所述设备还包含一传送工具，所述传送工具包含一中空的针，所述植体可滑动的通过所述针，其中所述套管的所述外径使得所述套管不致抓住所述中空的针的内部。
25.如权利要求24所述的设备，其特征在于：所述中空的针界定一个三重研磨斜角在所述针的一远端处，所述三重研磨斜角界定：
一个主要研磨部分，以及
两个侧研磨部分，不延伸以便彼此交会而界定位在所述针的一最远端部分处的一点。
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Application publication date: 20180529