CN106132347A - 具有带有rfid标签的手术工具的上电手术手持件 - Google Patents

具有带有rfid标签的手术工具的上电手术手持件 Download PDF

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CN106132347A
CN106132347A CN201580016492.6A CN201580016492A CN106132347A CN 106132347 A CN106132347 A CN 106132347A CN 201580016492 A CN201580016492 A CN 201580016492A CN 106132347 A CN106132347 A CN 106132347A
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S·格莱斯顿
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Abstract

上电手术手持件包括包含电动机的外壳，以及可移除地耦合至该外壳并被配置成由该电动机驱动的手术工具。该手术工具包括射频标识(RFID)标签。该手持件包括用于无线地传输RF能量的天线，以及与天线及RFID标签电隔离且被配置成将所传输的RF能量引导至该RFID标签的耦合器。

Description

具有带有RFID标签的手术工具的上电手术手持件
背景技术
在许多医学专业中，通常使用上电(powered)手术手持件来驱动手术工具。例如，上电手术手持件被用于在执行包括对解剖组织的钻孔、穿刺(tapping)、切除、解剖、清创、刮除、粉碎(pulverizing)和成形(shaping)的各种不同的切割类型功能中驱动手术钻、刀片或切割仪器。在耳鼻喉/头部/颈部和脊椎手术的领域中，手持件通常被配置用于选择性的耦合至各自被设计成执行特定程序的各种不同旋转类型的手术仪器，以及驱动这些手术仪器。在使用期间，基于特定的手术程序，外科医生选择合适的手术工具，并将其安装至上电手持件上。随后操作上电手持件以移动需要执行手术程序的工具中的一个或更多部件(例如，旋转、振荡)。可通过将不同样式的工具安装至同一上电手持件来稍后执行附加的程序性步骤。作为参考点，用于脊椎的或者其他硬骨头手术过程的上电手术手持件所典型需要的旋转速度在大约10-250rpm的范围内。耳鼻喉/头部/颈部过程在用于喉部浮物撇去操作的大约500rpm到用于高速钻孔操作的超过60000rpm之间变化。
除诸如使用无刷DC电动机之类的电动机改进之外，整个系统已开发成与上电旋转型的手术手持件以及相关的手术工具一起使用。除上电手持件以及一个或更多旋转型手术工具或仪器之外，典型的系统包括控制台以及将手持件连接至控制台的缆线。控制台被配置成激活和/或控制在其他方面与上电手术手持件相关联的电机的通电。例如，可提供手动或者脚踏开关作为系统的一部分。取决于外科医生对脚踏或手动开关的操作，相应的信号被递送至控制台，该控制台进而将手持件激励到相应的速度。
上电手术手持件提高的能力，以及现在可用的大量的手术工具，已毫无疑问地极大增加了外科医生可以使用单个手术系统执行的脊椎及耳鼻喉/头部/颈部程序的数量。然而，随着这些改进，外科医生现在期望单个上电手持件的甚至更好的性能、操作能力以及安全性。
根据以上，存在对在符合人体工程学尺寸的外壳中提供增强的性能能力的上电手术手持件的需要。
发明内容
一个实施例针对一种上电手术手持件，该上电手术手持件包括包含电动机的外壳，以及可移除地耦合至该外壳并被配置成由该电动机驱动的手术工具。手术工具包括射频标识(RFID)标签。手持件包括用于无线地传输RF能量的天线，以及与天线和RFID标签电隔离的耦合器，其中该耦合器被配置成将所传输的RF能量引导至该RFID标签。
另一个实施例针对一种手术系统，该手术系统包括包含电动机的上电手术手持件，以及可移除地连接至该手术手持件并被配置成由该电动机驱动的手术工具。手术工具包括超高频(UHF)射频标识(RFID)标签。手术系统包括连接至手术手持件并被编程为与手术手持件交互的控制器。控制器包括数据输入设备及显示屏。控制器被配置成基于存储在UHF RFID标签中的数据来标识连接至手术手持件的手术工具。
又一个实施例针对一种标识手术工具的方法。该方法包括提供包括电动机的上电手术手持件，以及可移除地连接至该手术手持件并被配置成由该电动机驱动的手术工具。该方法包括从该手术手持件中的天线无线地传输RF能量，以及使用手术手持件中的电隔离的耦合器将所传输的RF能量引导至手术工具中的射频标识(RFID)标签。被引导至RFID标签的RF能量使得RFID标签能够传输存储在RFID标签中的数据。该方法包括基于从RFID标签传输的数据来标识连接至手术手持件的手术工具。
附图说明
图1是示出了根据一个实施例的包括旋转类型的电动手术手持件的手术系统的框图。
图2是示出了根据一个实施例的在图1中示出的手术系统的部件的框图。
图3是示出了根据另一个实施例的在图1中示出的手术系统的部件的框图。
图4是示出了根据一个实施例的耦合器与天线之间的以及耦合器与RFID标签之间的近场耦合的示图。
图5是示出了根据一个实施例的存储在RFID标签中的数据的示图。
图6是示出了根据一个实施例的标识手术工具的方法的流程图。
具体实施方式
图1是示出了根据一个实施例的包括旋转类型的电动手术手持件20的手术系统的框图。在一些实施例中，提供和/或操作手持件20作为进一步包括控制器24的系统22的一部分。在提供的地方，控制器24具有微处理器且可包括(或被电子地连接至)诸如数据输入设备26及显示屏28之类的一个或多个部件。不论如何，一般来说，手持件20包括包含电动机的外壳，并被配置成选择性地接收手术仪器或工具30。在一个实施例中，手术工具30为一次性的刀片或骨钻(burr)。一旦连接至控制器24，系统22，且尤其是手持件20由用户进行操作以在执行期望的手术过程中旋转地驱动仪器30，其中控制器24基于从手持件20自动地发信号的信息来提供对手持件20的控制。各种特征可被纳入手持件20和/或系统22中而作为整体，包括电动机控制和反馈、刺激能量或神经完整性监测、手持件20与工具30之间的快速连接/断开、基于用户手指感测的安全超控(over-ride)、在手持件20处的模式-功能-方向控制、在极低及极高速度下的高扭矩操作等。
根据一个实施例的系统22被配置成执行手术工具识别(或刀片识别)，以使用基于无线超高频(UHF)的射频标识(RFID)技术来自动地标识当前附连至手持件20的手术工具30。在手术工具30中包括RFID标签214。系统22在控制器24或手持件20中没有特定产品信息的在前存储的情况下执行对手术工具30的标识或识别。根据一个实施例的RFID标签214永久地粘附至手术工具30的中枢(hub)中，其中标签214的顶部表面和底部表面平行于手术工具30的纵轴或附连轴32(即，RFID标签粘附在非轴向取向上)。
图2是示出了根据一个实施例的在图1中示出的手术系统22的部件的框图。图2中所示的手术系统22的实施例由附图标记22(1)标识。手术系统22(1)包括手持件20(1)、手术工具30(1)以及控制器24(1).手持件20(1)包括RFID读取器板202与耦合器210。读取器板202包括RFID读取器电路204与RFID天线206。手术工具30(1)包括RFID标签214。
控制器24(1)通过通信链路216将命令传输至读取器电路204，该通信链路在一个实施例中是具有串行数字线的缆线。RFID读取器电路204驱动天线206，该天线将RF能量208传输至耦合器210。在一个实施例中，RFID读取器电路204包括是RFID第二代兼容的(ISO18000-6C标准)集成电路芯片。RFID读取器电路204包括内部功率放大器与20dBm的发射功率。RFID读取器电路204包括读和写能力，以从RFID标签214读取数据，并将数据写入RFID标签214。
天线206为小型陶瓷元件，其在一个实施例中被集成至读取器板202内。在一个实施例中，天线206为来自约翰森技术(Johanson Technology)(零件号0920AT50A080)的陶瓷天线，具有11mm x 5.1mm x 1.5mm(长度x宽度x厚度)的覆盖范围(footprint)。在另一个实施例中，天线206包括印刷电路板(PCB)微带。RFID读取器板202与集成天线206一起被定位成接近手持件20(1)中的耦合器210。
耦合器210为无源刚性金属结构(单件或单构造)，其被封装在塑料中并被电隔离，且在制造手持件20(1)时被安装在手持件20(1)中。耦合器210用作天线206与RFID标签214之间的波导，并将RF能量从天线206输送至RFID标签214。RFID标签214为位于手术工具30(1)的基底部分中的无源元件。耦合器210未电连接至天线206或RFID标签214，而是通过接近这些元件将RF能量耦合至这些元件。由于缺乏直接的连接，耦合器210也可被称作“浮置的(floating)耦合器”。如图2所示，RF能量208从天线206传输，并由耦合器210接收。RF能量208穿过耦合器210，并从耦合器210发射作为RF能量212，该RF能量212被RFID标签214接收。RF能量212为无源RFID标签214供能，以允许RFID标签214通过耦合器210及天线206将存储的信息无线地传输回到读取器电路204。
在一个实施例中，RFID标签214包括是RFID第二代兼容的(ISO 18000-6C标准)英频杰(Impinj)RFID芯片。根据一个实施例的RFID标签214存储从128到8k位，并包含存储在ROM中的唯一的64位序列号。RFID标签214具有1.6mm x 1.6mm x 0.35mm(长度x宽度x厚度)的覆盖范围，以及860MHz到960MHz的操作频率。
图3是示出了根据另一个实施例的在图1中示出的手术系统22的部件的框图。图3中所示的手术系统22的实施例由附图标记22(2)标识。手术系统22(2)包括手持件20(2)、手术工具30(2)以及控制器24(2).手持件20(2)包括RFID天线206及耦合器210。手术工具30(2)包括RFID标签214。控制器24(2)包括RFID读取器电路204。
RFID读取器电路204安装在控制器24(2)中。通信链路316包括UHF同轴缆线或诸如包含在Cat 7A/8缆线中那些之类的双绞线，以将RF信号递送至手持件20(2)中的天线206。在手持件20(2)内部，天线206被定位成接近耦合器210，以将RF能量308传递穿过耦合器210至RFID标签214，如RF能量312所指示的。手术系统22(2)的元件以与手术系统22(1)基本上相同的方式操作，手术系统22(1)参照图2描述于上文。
图4是示出了根据一个实施例的耦合器210与天线206之间的以及耦合器210与RFID标签214之间的近场耦合的框图。耦合器210包括被定位成与天线206相邻但不与天线206接触的近端406，以及被定位成与RFID标签214相邻但不与RFID标签214接触的远端408。耦合器210的远端408与RFID标签214的紧邻提供了这些元件之间的近场耦合402(1)，且耦合器210的近端406与天线206的紧邻提供了这些元件之间的近场耦合402(2)。
图5是示出了根据一个实施例的存储在RFID标签214中的数据500的示图。如图5所示，数据500包括认证数据502、参数指导数据504、外科医生偏好数据506以及当前手术设置数据508。根据一个实施例的认证数据502包括唯一的序列号、认证码及写入数据，并可被用于防止对包含RFID标签214的手术工具30的不当使用或再使用。根据一个实施例的参数指导数据504包括：诸如包含RFID标签214的手术工具30的类型和/或型号(例如，4mm三切刀片(Tricut Blade))之类的参数数据；诸如最小与最大的旋转速度(例如，以每分钟旋转数或RPM为单位)之类的操作限制；可被用作默认设置的最佳的或推荐的操作参数，诸如最佳的或推荐的旋转速度和冲洗流量。根据一个实施例的外科医生偏好数据506包括外科医生偏好的旋转速度(例如，2500RPM)，以及外科医生偏好的冲洗流量(例如，40％的冲洗流量)。根据一个实施例的当前手术设置数据508包括对包含RFID标签214的手术工具30的当前或最后使用的设置，包括旋转速度、冲洗流量以及使用的时间的长度。数据500可被编码成标量数字(例如，RPM速度)、浮点数(例如，冲洗流量百分比)或布尔值(例如，真/假、是/否)。
在操作手持件20之前，由读取器电路204从RFID标签214读取诸如例如手术工具30(例如，刀片或骨钻)的安全操作的参数之类的来自RFID标签214的信息。此信息被发送至控制器24以用于设置操作指导与限制。数据还可在手持件20的使用期间被写入RFID标签214，包括更新外科医生偏好数据506及当前手术设置数据508。此数据也可被存储在控制器24中以便于不同手术工具30的快速改变和再使用。在手术工具30已从手持件20移除后，可由控制器24将该工具30的RFID标签214的序列号保留在表格中以供稍后使用。如果用于该手术的先前使用的手术工具30被再插入手持件20中，则序列号可被读取并与控制器24中的表格匹配。这允许控制器24对该手术工具30的先前设置被记起并被召回至操作设置。这潜在地可在过程期间减少用于改变手术工具30的时间。
一个实施例为每位外科医生提供默认偏好的存储。外科医生对操作参数的偏好在手术之前被存储在控制器24中。存储的默认参数是，例如，参考特定型号的手术工具30的默认旋转速度或冲洗设定。存储的默认值不限制于参考单个型号，而也可与产品族相关联。
一个实施例针对上电手术手持件，该手术手持件包括包含电动机的外壳，以及可移除地耦合至该外壳并被配置成由该电动机驱动的手术工具。手术工具包括射频标识(RFID)标签。手持件包括用于无线地传输RF能量的天线、以及与天线及RFID标签电隔离且被配置成将所传输的RF能量引导至RFID标签的耦合器。
在此实施例的一种形式中，RF能量包括超高频(UHF)RF信号。根据一个实施例的耦合器为封装在塑料中的无源金属结构。在一个实施例中，上电手术手持件包括在外壳中的RFID读取器电路，该RFID读取器电路被配置成驱动天线并从RFID标签读取数据及将数据写入RFID标签。RFID标签存储包括唯一序列号的认证数据；包括操作限制与默认操作参数的参数指导数据；外科医生的偏好操作参数；以及来自最后一次使用手术工具的最后使用的操作参数。在一个实施例中，当手术工具被移除并稍后在手持件中被重新使用时，手持件再次自动地使用最后使用的操作参数。
另一个实施例针对手术系统，该手术系统包括包含电动机的上电手术手持件，以及可移除地连接至该手术手持件并配置成由该电动机驱动的手术工具。手术工具包括超高频(UHF)射频标识(RFID)标签。手术系统包括连接至手术手持件并被编程为与手术手持件交互的控制器。控制器包括数据输入设备及显示屏。控制器被配置成基于存储在UHF RFID标签中的数据来标识连接至手术手持件的手术工具。
在此实施例的一种形式中，手术手持件包括用于无线地传输RF能量的天线、以及与天线及UHF RFID标签电隔离且被配置成将所传输的RF能量引导至UHF RFID标签的耦合器。耦合器为封装在塑料中的无源金属结构。在一个实施例中，手术手持件包括RFID读取器电路，该RFID读取器电路被配置成驱动天线并从UHF RFID标签读取数据及将数据写入UHFRFID标签。在另一个实施例中，控制器包括RFID读取器电路，该RFID读取器电路被配置成驱动天线并从UHF RFID标签读取数据及将数据写入UHF RFID标签。在此实施例的一种形式中，控制器经由缆线被耦合至手术手持件，该缆线包括被配置成将UHF RF能量递送至天线的双绞线。UHF RFID标签存储包括唯一序列号的认证数据；包括操作限制与默认操作参数的参数指导数据；以及来自最后一次使用手术工具的最后使用的操作参数。
又一个实施例针对标识手术工具的方法。图6是示出了根据一个实施例的标识手术工具的方法600的流程图。在一个实施例中，系统22(图1)被配置成执行方法600.在方法600中的602处，提供了包括电动机的上电手术手持件，以及可移除地连接至手术手持件并被配置成由电动机驱动的手术工具。在604处，从手术手持件中的天线无线地传输RF能量。在606处，所传输的RF能量使用手术手持件中的电隔离的耦合器被引导至手术工具中的射频标识(RFID)标签，其中被引导至RFID标签的RF能量使得RFID标签能够传输存储在RFID标签中的数据。在608处，基于从RFID标签传输的数据来标识连接至手术手持件的手术工具。
本文公开的实施例相对现有技术提供了诸多优点。本文公开的实施例允许使用EPC第二代ISO标准RFID标签。可将操作指导而不仅仅是产品ID编程至RFID标签214内。一些现有设备使用螺旋电感线圈及基于高频(HF—例如，13.56MHZ)或低频(LF—例如，134KHZ)的RFID技术。相反，本文公开的一些实施例使用超高频(UHF—例如，915MHZ),且在手持件中不使用螺旋电感线圈来激励无源RFID标签214.在UHF频率处，这种线圈可变得自振而具有不可预知的行为。此外，线圈由于制造要求针对性能测量和调谐线圈而呈现出挑战。此外，当被重复地暴露于诸如利用高压灭菌器消毒的高热量时，线圈呈现出调谐不稳定性。
耦合器210为无需调谐或复杂安装的塑料封装结构。耦合器210易于使用，例如，计算机数控(CNC)制造过程或金属冲压来制造。耦合器210允许手持件20中的天线206的较简单安装，并消除了对手持件20中的同轴缆线的需求。无需焊接到耦合器210。耦合器210允许天线206被设计到手持件20的背面内或最佳的任何地方而并非仅靠近RFID标签214被定位的地方。耦合器210对制造变化、高压灭菌器消毒循环及正常使用也是容忍且鲁棒的。
本文公开的实施例在上电手术仪器中执行刀片识别，这对于下一代高速骨钻和刀片来说是重要的特征。用于手持件20的不同的手术工具30在RPM、冲洗、旋转方向和振荡速度方面具有用于最佳性能的参数。刀片识别允许基于每件产品执行操作指导，这提高了安全性并减少了风险。
虽然已参考优选实施例对本公开进行描述，但是本领域的技术人员将认识到可作形式或细节上的改变而不背离本公开的精神和范围。

Claims (20)

1.一种上电手术手持件，包括：
外壳，所述外壳包括电动机；
手术工具，可移除地耦合至所述外壳并被配置成由所述电动机驱动，其中所述手术工具包括射频标识(RFID)标签；
天线，用于无线地传输RF能量；以及
耦合器，与所述天线及所述RFID标签电隔离，且被配置成将所传输的RF能量引导至所述RFID标签。
2.如权利要求1所述的上电手术手持件，其特征在于，所述RF能量包括超高频(UHF)RF信号。
3.如权利要求1所述的上电手术手持件，其特征在于，所述耦合器为封装在塑料中的无源金属结构。
4.如权利要求1所述的上电手术手持件，并进一步包括：
在所述外壳中的RFID读取器电路，所述RFID读取器电路被配置成驱动所述天线并从所述RFID标签读取数据及将数据写入所述RFID标签。
5.如权利要求1所述的上电手术手持件，其特征在于，所述RFID标签存储包括唯一序列号的认证数据。
6.如权利要求1所述的上电手术手持件，其特征在于，所述RFID标签存储包括操作限制的参数指导数据。
7.如权利要求6所述的上电手术手持件，其特征在于，所述参数指导数据进一步包括默认操作参数。
8.如权利要求1所述的上电手术手持件，其特征在于，所述RFID标签存储外科医生的偏好操作参数。
9.如权利要求1所述的上电手术手持件，其特征在于，所述RFID标签存储来自最后一次使用所述手术工具的最后使用的操作参数。
10.如权利要求9所述的上电手术手持件，其特征在于，当所述手术工具被移除并稍后在所述手持件中被重新使用时，所述手持件再次自动地使用所述最后使用的操作参数。
11.一种手术系统，包括：
上电手术手持件，所述上电手术手持件包括电动机；
手术工具，可移除地连接至所述手术手持件并被配置成由所述电动机驱动，其中所述手术工具包括超高频(UHF)射频标识(RFID)标签；以及
控制器，连接至所述手术手持件并被编程为与所述手术手持件交互，所述控制器包括数据输入设备以及显示屏，其中所述控制器被配置成基于存储在所述UHF RFID标签中的数据来标识连接至所述手术手持件的手术工具。
12.如权利要求11所述的手术系统，其特征在于，所述手术手持件包括用于无线地传输RF能量的天线，以及与所述天线及所述UHF RFID标签电隔离且被配置成将所传输的RF能量引导至所述UHF RFID标签的耦合器。
13.如权利要求12所述的手术系统，其特征在于，所述耦合器为封装在塑料中的无源金属结构。
14.如权利要求12所述的手术系统，其特征在于，所述手术手持件包括RFID读取器电路，所述RFID读取器电路被配置成驱动所述天线，并从所述UHF RFID标签读取数据及将数据写入所述UHF RFID标签。
15.如权利要求12所述的手术系统，其特征在于，所述控制器包括RFID读取器电路，所述RFID读取器电路被配置成驱动所述天线，并从所述UHF RFID标签读取数据及将数据写入所述UHF RFID标签。
16.如权利要求15所述的手术系统，其特征在于，所述控制器经由缆线被耦合至所述手术手持件，所述缆线包括被配置成将UHF RF能量递送至所述天线的双绞线。
17.如权利要求11所述的手术系统，其特征在于，所述UHF RFID标签存储包括唯一序列号的认证数据。
18.如权利要求11所述的手术系统，其特征在于，所述UHF RFID标签存储包括操作限制和默认操作参数的参数指导数据。
19.如权利要求11所述的手术系统，其特征在于，所述UHF RFID标签存储来自最后一次使用所述手术工具的最后使用的操作参数。
20.一种标识手术工具的方法，包括：
提供包括电动机的上电手术手持件，以及可移除地连接至所述手术手持件并被配置成由所述电动机驱动的手术工具；
从所述手术手持件中的天线无线地传输RF能量；
使用所述手术手持件中的电隔离的耦合器将所传输的RF能量引导至所述手术工具中的射频标识(RFID)标签，其中，被引导至所述RFID标签的所述RF能量使得所述RFID标签能够传输存储在所述RFID标签中的数据；以及
基于从所述RFID标签传输的数据来标识连接至所述手术手持件的手术工具。
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Application publication date: 20161116