CN117202864A - Flexible sensor assembly for ENT instrument - Google Patents

Flexible sensor assembly for ENT instrument Download PDF

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Publication number
CN117202864A
CN117202864A CN202280029241.1A CN202280029241A CN117202864A CN 117202864 A CN117202864 A CN 117202864A CN 202280029241 A CN202280029241 A CN 202280029241A CN 117202864 A CN117202864 A CN 117202864A
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sensor
navigation sensor
distal
trace
navigation
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Inventor
F·D·塔克
M·巴尔-塔尔
V·格莱纳
B·易卜拉希米
U·霍德
S·巴苏
A·D·赖特
C·富恩特斯-奥尔特加
H·F·萨拉查
J·帕卢什
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Biosense Webster Israel Ltd
Acclarent Inc
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Biosense Webster Israel Ltd
Acclarent Inc
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Priority claimed from US17/584,693 external-priority patent/US20220257093A1/en
Application filed by Biosense Webster Israel Ltd, Acclarent Inc filed Critical Biosense Webster Israel Ltd
Priority claimed from PCT/IB2022/051442 external-priority patent/WO2022175877A2/en
Publication of CN117202864A publication Critical patent/CN117202864A/en
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Abstract

本发明提供了一种ENT外科器械,该ENT外科器械包括轴组件、柔性基板和形成在该柔性基板上的至少一个导电传感器迹线。该轴组件具有远侧端部,该远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中。该柔性基板沿该轴的至少一部分延伸。该至少一个传感器迹线包括至少一个同心环部分,其中该至少一个同心环部分限定至少一个导航传感器。The present invention provides an ENT surgical instrument including a shaft assembly, a flexible substrate, and at least one conductive sensor trace formed on the flexible substrate. The shaft assembly has a distal end sized and configured to fit within an anatomical passage in the patient's ear, nose, or throat. The flexible substrate extends along at least a portion of the axis. The at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor.

Description

用于ENT器械的柔性传感器组件Flexible sensor components for ENT devices

背景技术Background technique

图像引导外科手术(IGS)为一种这样的技术:其中使用计算机来获得已经插入患者体内的器械的位置与一组手术前获得的图像(例如,CT或MRI扫描、3-D标测图等)的实时相关性,使得计算机系统可在手术前获得的图像上叠加器械的当前位置。可用于IGS规程中的电磁IGS导航系统的示例为由Biosense-Webster,Inc.(Irvine,California)提供的3系统。在一些IGS规程中,在外科手术之前获得手术区的数字断层扫描(例如,CT或MRI、3D标测图等)。然后使用专门编程的计算机将数字断层扫描数据转化成数字标测图。在外科手术期间,具有传感器(例如,发出电磁场和/或响应于外部生成电磁场的电磁线圈)的特殊器械用于执行规程,同时传感器向计算机发送指示每个外科器械的当前位置的数据。该计算机将从传感器接收的数据与由手术前断层扫描生成的数字标测图相关联。断层扫描图像连同指示标识(例如,十字准线或发光点等)一起示于视频监视器上,从而示出每个外科器械相对于扫描图像中所示解剖结构的实时位置。因此,即使外科医生不能在体内器械当前位置处直接目视查看器械本身,但外科医生能够通过查看视频监视器而了解每个配备传感器的器械的确切位置。Image-guided surgery (IGS) is a technique in which a computer is used to obtain the position of an instrument that has been inserted into the patient's body in conjunction with a set of images obtained prior to surgery (e.g., CT or MRI scans, 3-D mapping, etc. ) allows the computer system to superimpose the current position of the instrument on the image obtained before surgery. An example of an electromagnetic IGS navigation system that may be used in the IGS protocol is provided by Biosense-Webster, Inc. (Irvine, California) 3 systems. In some IGS procedures, a digital tomogram of the surgical field (eg, CT or MRI, 3D mapping, etc.) is obtained prior to the surgical procedure. The digital tomography data are then converted into digital maps using specially programmed computers. During surgical procedures, special instruments with sensors (eg, electromagnetic coils that emit electromagnetic fields and/or respond to externally generated electromagnetic fields) are used to perform the procedure, while the sensors send data to the computer indicating the current location of each surgical instrument. The computer correlates data received from the sensors with digital maps generated from pre-operative tomography scans. The tomographic scan images are shown on a video monitor along with indicators (eg, crosshairs, glowing dots, etc.) showing the real-time position of each surgical instrument relative to the anatomy shown in the scanned image. Therefore, even though the surgeon cannot directly visually view the instrument itself at its current position within the body, the surgeon is able to understand the exact location of each sensor-equipped instrument by viewing the video monitor.

在一些情况下,可能期望扩张患者体内的解剖通道。这可包括鼻旁窦口扩张(例如,以治疗鼻窦炎)、喉扩张、咽鼓管扩张、耳、鼻或喉内其他通道的扩张等。扩张解剖通道的一种方法包括使用导丝和导管将可充胀球囊定位在解剖通道内,然后用流体(例如,盐水)使球囊充胀以扩张解剖通道。例如,可膨胀球囊可定位在鼻旁窦处的口内,并且然后充胀,以由此通过重塑与该口相邻的骨来扩张口,而不需要切开粘膜或移除任何骨。然后扩张的口可允许改善从受影响的鼻旁窦的引流和通气。In some cases, it may be desirable to dilate anatomical passages within the patient's body. This may include dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilatation, Eustachian tube dilation, ear, nose, or other passages within the throat, etc. One method of dilating an anatomical channel involves using a guidewire and catheter to position an inflatable balloon within the anatomical channel and then inflating the balloon with a fluid (eg, saline) to dilate the anatomical channel. For example, an inflatable balloon can be positioned within the mouth at the paranasal sinus and then inflated to thereby expand the mouth by reshaping the bone adjacent to the mouth without the need to incise the mucosa or remove any bone. The dilated orifice may then allow improved drainage and ventilation from the affected paranasal sinuses.

在咽鼓管扩张的情况下,可将扩张导管或其他扩张器械插入咽鼓管中,然后使其充胀或以其他方式膨胀从而扩张咽鼓管。扩张的咽鼓管可提供改善的从鼻咽到中耳的通气,并进一步提供改善的从中耳到鼻咽的引流。In the case of Eustachian tube dilation, a dilation catheter or other dilation device may be inserted into the Eustachian tube and then inflated or otherwise expanded to dilate the Eustachian tube. A dilated Eustachian tube provides improved ventilation from the nasopharynx to the middle ear and further provides improved drainage from the middle ear to the nasopharynx.

可能期望在解剖通道中(包括在将仅由单个操作者执行的规程中)易于控制地放置扩张导管或其他ENT器械。尽管已研制出若干系统和方法并用于将扩张导管或其他ENT器械定位在解剖通道中,但是据信,本发明人之前尚未有人研制出或使用所附权利要求书中所描述的发明。It may be desirable to easily controllable placement of dilation catheters or other ENT devices in an anatomical passage, including in procedures that will be performed by only a single operator. Although several systems and methods have been developed and used to position dilation catheters or other ENT devices within anatomical passages, it is believed that no one has before made or used the invention described in the appended claims.

附图说明Description of the drawings

以下附图和具体实施方式旨在仅为例示性的,而不旨在限制本发明人所设想的本发明的范围。The following drawings and detailed description are intended to be illustrative only and are not intended to limit the scope of the invention contemplated by the inventors.

图1示出了在坐在示例性医疗规程座椅中的患者上使用的示例性外科手术导航系统的示意图;1 shows a schematic diagram of an exemplary surgical navigation system used on a patient seated in an exemplary medical procedure chair;

图2示出了具有柔性导航传感器组件的示例性器械的透视图;Figure 2 shows a perspective view of an exemplary instrument with a flexible navigation sensor assembly;

图3示出了图2的器械的远侧部分的透视图,示出了处于平坦构型的横跨轴的内径延伸的柔性导航传感器组件;3 illustrates a perspective view of a distal portion of the instrument of FIG. 2 showing a flexible navigation sensor assembly extending across the inner diameter of the shaft in a flat configuration;

图4示出了图3的柔性导航传感器组件的顶部平面图;Figure 4 shows a top plan view of the flexible navigation sensor assembly of Figure 3;

图5示出了图3的柔性导航传感器组件的底部平面图;Figure 5 shows a bottom plan view of the flexible navigation sensor assembly of Figure 3;

图6示出了图3的柔性导航传感器组件的近侧部分的顶部平面图;Figure 6 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 3;

图7示出了图3的柔性导航传感器组件的中间部分的顶部平面图;Figure 7 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 3;

图8示出了图3的柔性导航传感器组件的远侧部分的顶部平面图;Figure 8 shows a top plan view of a distal portion of the flexible navigation sensor assembly of Figure 3;

图9示出了图3的柔性导航传感器组件的近侧部分的底部平面图;Figure 9 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 3;

图10示出了图3的柔性导航传感器组件的中间部分的底部平面图;Figure 10 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 3;

图11示出了图3的柔性导航传感器组件的远侧部分的底部平面图;Figure 11 shows a bottom plan view of a distal portion of the flexible navigation sensor assembly of Figure 3;

图12示出了图3的柔性导航传感器组件的示意性电路图;Figure 12 shows a schematic circuit diagram of the flexible navigation sensor assembly of Figure 3;

图13示出了图2的器械的远侧部分的透视图,示出了处于弯曲构型的沿轴的内柱形表面设置的柔性导航传感器组件;13 illustrates a perspective view of the distal portion of the instrument of FIG. 2 showing the flexible navigation sensor assembly disposed along the inner cylindrical surface of the shaft in a curved configuration;

图14示出了耦接到另一示例性柔性导航传感器组件的图2的器械的可视化和冲洗组件的远侧部分的透视图;14 shows a perspective view of a distal portion of the visualization and irrigation assembly of the instrument of FIG. 2 coupled to another exemplary flexible navigation sensor assembly;

图15示出了图14的柔性导航传感器组件的顶部平面图;Figure 15 shows a top plan view of the flexible navigation sensor assembly of Figure 14;

图16示出了图14的柔性导航传感器组件的底部平面图;Figure 16 shows a bottom plan view of the flexible navigation sensor assembly of Figure 14;

图17示出了图14的柔性导航传感器组件的近侧部分的顶部平面图;Figure 17 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 14;

图18示出了图14的柔性导航传感器组件的中间部分的顶部平面图;Figure 18 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 14;

图19示出了图14的柔性导航传感器组件的远侧部分的顶部平面图;Figure 19 shows a top plan view of the distal portion of the flexible navigation sensor assembly of Figure 14;

图20示出了图14的柔性导航传感器组件的近侧部分的底部平面图;Figure 20 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 14;

图21示出了图14的柔性导航传感器组件的中间部分的底部平面图;Figure 21 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 14;

图22示出了图14的柔性导航传感器组件的远侧部分的底部平面图;Figure 22 shows a bottom plan view of a distal portion of the flexible navigation sensor assembly of Figure 14;

图23示出了用于根据从图14的柔性导航传感器组件接收的信号来确定ENT器械的一部分的位置坐标的示例性方法的流程图;23 illustrates a flowchart of an exemplary method for determining position coordinates of a portion of an ENT instrument based on signals received from the flexible navigation sensor assembly of FIG. 14;

图24示出了具有柔性导航传感器组件的另一示例性器械的透视图;Figure 24 shows a perspective view of another exemplary instrument with a flexible navigation sensor assembly;

图25A示出了图24的器械的远侧部分的透视图,示出了处于直线构型的器械的柔性远侧轴部分,并且进一步示出了处于第一弯曲构型的沿柔性远侧部分的内柱形表面设置的柔性导航传感器组件;Figure 25A shows a perspective view of the distal portion of the instrument of Figure 24, showing the flexible distal shaft portion of the instrument in a straight configuration, and further showing the flexible distal portion along the first curved configuration. A flexible navigation sensor assembly provided on the inner cylindrical surface;

图25B示出了图24的器械的远侧部分的透视图,示出了处于弯曲构型的器械的柔性远侧轴部分,并且进一步示出了处于第二弯曲构型的沿柔性远侧部分的内柱形表面设置的柔性导航传感器组件;Figure 25B illustrates a perspective view of the distal portion of the instrument of Figure 24, showing the flexible distal shaft portion of the instrument in a curved configuration, and further illustrating the flexible distal portion along the flexible distal portion in a second curved configuration. A flexible navigation sensor assembly provided on the inner cylindrical surface;

图26A示出了处于平坦构型的图25A的柔性导航传感器组件的透视图;Figure 26A shows a perspective view of the flexible navigation sensor assembly of Figure 25A in a flat configuration;

图26B示出了处于侧向弯曲、纵向直线构型的图25A的柔性导航传感器组件的侧正视图;Figure 26B shows a side elevation view of the flexible navigation sensor assembly of Figure 25A in a laterally curved, longitudinally straight configuration;

图26C示出了处于侧向弯曲、纵向弯曲构型的图25A的柔性导航传感器组件的侧正视图;Figure 26C shows a side elevation view of the flexible navigation sensor assembly of Figure 25A in a laterally bent, longitudinally bent configuration;

图27A示出了具有柔性导航传感器组件的示例性抽吸器械的远侧部分的透视图,示出了处于直线构型的抽吸器械的可延展轴,并且进一步示出了处于第一弯曲构型的沿可延展轴的外柱形表面设置的柔性导航传感器组件;27A illustrates a perspective view of a distal portion of an exemplary suction instrument with a flexible navigation sensor assembly, showing the extensible shaft of the suction instrument in a linear configuration, and further illustrating a first curved configuration. A flexible navigation sensor assembly arranged along the outer cylindrical surface of the extendable shaft;

图27B示出了图27A的抽吸器械的远侧部分的透视图,示出了处于弯曲构型的抽吸器械的可延展轴,并且进一步示出了处于第二弯曲构型的沿可延展轴的外柱形表面设置的柔性导航传感器组件;Figure 27B shows a perspective view of a distal portion of the suction instrument of Figure 27A, showing the extensible shaft of the suction instrument in a curved configuration, and further illustrating the extensible shaft along the suction instrument in a second curved configuration. a flexible navigation sensor assembly provided on the outer cylindrical surface of the shaft;

图27C示出了图27A的抽吸器械的远侧部分的透视图,示出了处于双弯曲构型的抽吸器械的可延展轴,并且进一步示出了处于第三弯曲构型的沿可延展轴的外柱形表面设置的柔性导航传感器组件;Figure 27C shows a perspective view of the distal portion of the suction instrument of Figure 27A, showing the extensible shaft of the suction instrument in a double curved configuration, and further illustrating the extensible shaft in a third curved configuration. a flexible navigation sensor assembly provided on the outer cylindrical surface of the extension shaft;

图28示出了具有柔性导航传感器组件的示例性组织剃刮器械的透视图;Figure 28 shows a perspective view of an exemplary tissue shaving instrument with a flexible navigation sensor assembly;

图29示出了图28的组织剃刮器械的外管的透视图,示出了处于第一弯曲构型的沿外管的外柱形表面设置的柔性导航传感器组件;29 illustrates a perspective view of the outer tube of the tissue shaving instrument of FIG. 28 showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the outer tube in a first curved configuration;

图30示出了处于平坦构型的图29的柔性导航传感器组件的顶部平面图;Figure 30 shows a top plan view of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图31示出了处于平坦构型的图29的柔性导航传感器组件的底部平面图;Figure 31 shows a bottom plan view of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图32示出了处于平坦构型的图29的柔性导航传感器组件的近侧部分的顶部平面图;Figure 32 shows a top plan view of the proximal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图33示出了处于平坦构型的图29的柔性导航传感器组件的中间部分的顶部平面图;Figure 33 shows a top plan view of the middle portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图34示出了处于平坦构型的图29的柔性导航传感器组件的远侧部分的顶部平面图;Figure 34 shows a top plan view of the distal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图35示出了处于平坦构型的图29的柔性导航传感器组件的近侧部分的底部平面图;Figure 35 shows a bottom plan view of the proximal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图36示出了处于平坦构型的图29的柔性导航传感器组件的中间部分的底部平面图;Figure 36 shows a bottom plan view of the middle portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图37示出了处于平坦构型的图29的柔性导航传感器组件的远侧部分的底部平面图;Figure 37 shows a bottom plan view of the distal portion of the flexible navigation sensor assembly of Figure 29 in a flat configuration;

图38示出了具有图29的柔性导航传感器组件的另一示例性组织剃刮器械的透视图,示出了处于第二弯曲构型的沿外管的外柱形表面设置的柔性导航传感器组件;38 illustrates a perspective view of another exemplary tissue shaving instrument having the flexible navigation sensor assembly of FIG. 29, showing the flexible navigation sensor assembly disposed along the outer cylindrical surface of the outer tube in a second curved configuration. ;

图39示出了带有可移除地固定到组织剃刮器械的导航适配器护套的另一示例性组织剃刮器械的透视图;39 shows a perspective view of another exemplary tissue shaving instrument with a navigation adapter sheath removably secured to the tissue shaving instrument;

图40示出了图39的组织剃刮器械和导航适配器护套的透视图,其中导航适配器护套从组织剃刮器械移除;Figure 40 shows a perspective view of the tissue shaving instrument and navigation adapter sheath of Figure 39 with the navigation adapter sheath removed from the tissue shaving instrument;

图41示出了图39的导航适配器护套的轴组件的分解透视图;Figure 41 shows an exploded perspective view of the shaft assembly of the navigation adapter boot of Figure 39;

图42示出了沿图39的线42-42截取的图41的轴组件的剖面端视图;Figure 42 shows a cross-sectional end view of the shaft assembly of Figure 41 taken along line 42-42 of Figure 39;

图43示出了图39的组织剃刮器械和导航适配器护套的远侧部分的透视图,其中导航适配器护套固定到组织剃刮器械,并且省略了轴组件的外轴以显露柔性电路的定位;Figure 43 shows a perspective view of the distal portion of the tissue shaving instrument and navigation adapter sheath of Figure 39, with the navigation adapter sheath secured to the tissue shaving instrument and with the outer shaft of the shaft assembly omitted to reveal the flexible circuitry. position;

图44示出了用于校准柔性导航传感器组件的示例性方法的流程图;44 illustrates a flow diagram of an exemplary method for calibrating a flexible navigation sensor assembly;

图45示出了使用图44的方法获取的示例性几何测量的照片;Figure 45 shows a photograph of an exemplary geometric measurement obtained using the method of Figure 44;

图46示出了另一示例性组织剃刮器械的轴组件的远侧部分的透视图,其中包括结合的消融柔性电路的第一示例;46 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a first example of an incorporated ablation flex circuit;

图47示出了另一示例性组织剃刮器械的轴组件的远侧部分的透视图,其中包括结合的消融柔性电路的第二示例;47 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a second example of an incorporated ablation flex circuit;

图48示出了另一示例性组织剃刮器械的轴组件的远侧部分的透视图,其中包括结合的消融柔性电路的第三示例;并且48 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a third example of an incorporated ablation flex circuit; and

图49示出了另一示例性组织剃刮器械的轴组件的远侧部分的透视图,其中包括结合的消融柔性电路的第四示例。49 shows a perspective view of a distal portion of a shaft assembly of another exemplary tissue shaving instrument including a fourth example of an incorporated ablation flex circuit.

具体实施方式Detailed ways

本发明的某些示例的以下说明不应用于限定本发明的范围。根据以举例的方式(设想的用于实施本发明的最佳方式中的一种)示出的以下说明,本发明的其他示例、特征、方面、实施方案和优点对于本领域的技术人员而言将变得显而易见。如将认识到,本发明能够具有其他不同且明显的方面,所有这些方面均不脱离本发明。因此,附图和说明应被视为实质上是例示性的而非限制性的。The following description of certain examples of the invention should not be used to limit the scope of the invention. Other examples, features, aspects, embodiments and advantages of the invention will become apparent to those skilled in the art from the following description, which is presented by way of example as one of the best modes contemplated for carrying out the invention. will become apparent. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

为公开的清楚起见,术语“近侧”和“远侧”在本文中是相对于握持具有远侧外科端部执行器的外科器械的外科医生或其他操作者定义的。术语“近侧”是指元件更靠近外科医生布置的位置,并且术语“远侧”是指元件更靠近外科器械的外科端部执行器且更远离外科医生布置的位置。此外,在本文中参照附图来使用空间术语诸如“上部”、“下部”、“竖直”、“水平”等的程度,应当理解,此类术语仅用于示例性描述目的,并且不旨在是限制性的或绝对的。就这一点而言,应当理解,外科器械诸如本文所公开的那些可以不限于本文所示和所述的那些取向和位置的多种取向和位置使用。For clarity of disclosure, the terms "proximal" and "distal" are defined herein with respect to a surgeon or other operator holding a surgical instrument having a distal surgical end effector. The term "proximal" refers to a location where an element is closer to a surgeon's placement, and the term "distal" refers to a location where an element is closer to a surgical end effector of a surgical instrument and further away from a surgeon's placement. Furthermore, to the extent that spatial terms such as "upper," "lower," "vertical," "horizontal," etc. are used herein with reference to the drawings, it is to be understood that such terms are for illustrative purposes only and are not intended to is restrictive or absolute. In this regard, it should be understood that surgical instruments such as those disclosed herein may be used in a variety of orientations and positions that are not limited to those shown and described herein.

如本文所用,针对任何数值或范围的术语“约”和“大约”表示允许零件或多个部件的集合执行如本文所述的其指定用途的合适的尺寸公差。As used herein, the terms "about" and "approximately" with respect to any numerical value or range mean suitable dimensional tolerances that allow a part or collection of components to perform its intended use as described herein.

I.示例性图像引导的外科手术导航系统I. Exemplary Image-Guided Surgical Navigation System

当在患者(P)的头部(H)内执行医疗规程时,可能期望的是获得关于器械在患者(P)的头部(H)内位置的信息,尤其是在器械处于难以或不可能获得器械的工作元件在患者(P)的头部(H)内的内窥镜视图的位置时。图1示出了使得能够利用图像引导执行ENT规程的示例性IGS导航系统(50)。除了具有本文所述的部件和可操作性之外或者代替本文所述的部件和可操作性,IGS导航系统(50)可根据以下专利的教导内容中的至少一些教导内容来构造和操作:2010年5月18日公布的名称为“Methods and Devices for PerformingProcedures within the Ear,Nose,Throat and Paranasal Sinuses”的美国专利7,720,521号和2014年12月11日公布的名称为“Systems and Methods for Performing ImageGuided Procedures within the Ear,Nose,Throat and Paranasal Sinuses”的现在已放弃的美国专利公布2014/0364725。When performing a medical procedure within the head (H) of a patient (P), it may be desirable to obtain information regarding the position of an instrument within the head (H) of the patient (P), especially when the instrument is in a position where it is difficult or impossible to An endoscopic view is obtained of the position of the working element of the instrument within the head (H) of the patient (P). Figure 1 illustrates an exemplary IGS navigation system (50) that enables performance of ENT procedures using image guidance. In addition to or in lieu of the components and operability described herein, the IGS navigation system (50) may be constructed and operative in accordance with the teachings of at least some of the following patents: 2010 U.S. Patent No. 7,720,521 titled "Methods and Devices for Performing Procedures within the Ear, Nose, Throat and Paranasal Sinuses" published on May 18, 2014 and "Systems and Methods for Performing ImageGuided Procedures" published on December 11, 2014 Now-abandoned U.S. Patent Publication 2014/0364725 of "within the Ear, Nose, Throat and Paranasal Sinuses".

本示例的IGS导航系统(50)包括场发生器组件(60),该场发生器组件包括集成到马蹄形框架(62)中的一组磁场发生器(64)。场发生器(64)能够操作以生成围绕患者(P)的头部(H)的不同频率的交变磁场。诸如下文所述的器械中的任一者的器械可插入患者(P)的头部(H)中。此类器械可以是独立的装置或者可以被定位在端部执行器上。在本示例中,将框架(62)安装到座椅(70),患者(P)坐在座椅(70)中,使得框架(62)位于患者(P)的头部(H)附近。仅以举例的方式,座椅(70)和/或场发生器组件(60)能够根据2020年2月18日公布的名称为“Apparatus to Secure Field Generating Device to Chair”的美国专利10,561,370号的教导内容中的至少一些教导内容来构造和操作。The IGS navigation system (50) of this example includes a field generator assembly (60) that includes a set of magnetic field generators (64) integrated into a horseshoe frame (62). The field generator (64) is operable to generate alternating magnetic fields of different frequencies around the head (H) of the patient (P). An instrument such as any of those described below may be inserted into the head (H) of the patient (P). Such instruments may be stand-alone devices or may be positioned on the end effector. In this example, the frame (62) is mounted to a seat (70) in which the patient (P) sits such that the frame (62) is located near the patient's (P) head (H). By way of example only, the seat (70) and/or the field generator assembly (60) can be configured in accordance with the teachings of U.S. Patent No. 10,561,370 entitled "Apparatus to Secure Field Generating Device to Chair" published on February 18, 2020 At least some of the content teaches how to construct and operate.

本示例的IGS导航系统(50)还包括处理器(52),该处理器控制场发生器(64)和IGS导航系统(50)的其他元件。例如,处理器(52)能够操作以驱动场发生器(64)生成交变电磁场;以及处理来自器械的信号,以确定器械中的导航传感器或位置传感器在患者(P)的头部(H)内的位置。处理器(52)包括与一个或多个存储器通信的处理单元(例如,布置成使用组合逻辑电路或其他类似电路评估和执行软件指令的一组电子电路)。本示例的处理器(52)被安装在控制台(58)中,该控制台包括操作控件(54),该操作控件包括键盘和/或指向装置,诸如鼠标或轨迹球。在执行外科规程时,医师使用操作控件(54)与处理器(52)进行交互。The IGS navigation system (50) of this example also includes a processor (52) that controls the field generator (64) and other elements of the IGS navigation system (50). For example, the processor (52) is operable to drive the field generator (64) to generate an alternating electromagnetic field; and to process signals from the instrument to determine the position of a navigation sensor or position sensor in the instrument on the head (H) of the patient (P) location within. The processor (52) includes a processing unit (eg, a set of electronic circuits arranged to evaluate and execute software instructions using combinational logic circuits or other similar circuits) in communication with one or more memories. The processor (52) of this example is mounted in a console (58) that includes operational controls (54) including a keyboard and/or pointing device, such as a mouse or trackball. The physician interacts with processor (52) using operating controls (54) while performing a surgical procedure.

虽然未示出,但器械可包括响应于定位在由场发生器(64)生成的交变磁场内的导航传感器或位置传感器。联接单元(未示出)可固定到器械的近侧端部并且可被配置成在控制台(58)和器械之间提供数据和其他信号的通信。联接单元可提供数据和其他信号的有线或无线通信。Although not shown, the instrument may include a navigation sensor or a position sensor responsive to positioning within the alternating magnetic field generated by the field generator (64). A coupling unit (not shown) may be secured to the proximal end of the instrument and may be configured to provide communication of data and other signals between the console (58) and the instrument. The connection unit provides wired or wireless communication of data and other signals.

在一些型式中,器械的导航传感器或位置传感器可在器械的远侧端部处或附近包括至少一个线圈。当此类线圈定位在由场发生器(64)生成的交变电磁场内时,交变磁场可在线圈中生成电流,并且此电流可沿着器械中的电导管传送,并且经由联接单元进一步传送到处理器(52)。该现象可使IGS导航系统(50)能够确定器械的远侧端部在三维空间内(即,在患者(P)的头部(H)内等)的位置。为了实现这一点,处理器(52)执行算法以根据器械中线圈的位置相关信号来计算器械的远侧端部的位置坐标。因此,导航传感器可通过生成指示传感器在三维空间内的实时位置的信号来用作位置传感器。In some versions, the instrument's navigation sensor or position sensor may include at least one coil at or near the distal end of the instrument. When such a coil is positioned within an alternating electromagnetic field generated by the field generator (64), the alternating magnetic field can generate an electric current in the coil, and this electric current can be transmitted along the electrical conduits in the instrument and further via the coupling unit to processor(52). This phenomenon may enable the IGS navigation system (50) to determine the position of the distal end of the instrument within three-dimensional space (i.e., within the head (H) of the patient (P), etc.). To achieve this, the processor (52) executes an algorithm to calculate the position coordinates of the distal end of the instrument based on the position-related signals of the coils in the instrument. Navigation sensors can therefore function as position sensors by generating signals that indicate the sensor's real-time position within three-dimensional space.

处理器(52)使用存储在处理器(52)的存储器中的软件来校准和操作IGS导航系统(50)。此类操作包括驱动场发生器(64)、处理来自器械的数据、处理来自操作控件(54)的数据以及驱动显示屏(56)。在一些具体实施中,操作还可包括监控以及强制执行IGS导航系统(50)的一个或多个安全特征部或功能。处理器(52)能够进一步操作以经由显示屏(56)提供实时视频,显示出器械的远侧端部相对于患者头部(H)的相机图像、患者头部(H)的CT扫描图像和/或患者鼻腔内以及患者鼻腔附近的解剖结构的计算机生成的三维模型的位置。显示屏(56)可在外科规程期间同时地和/或彼此叠加地显示此类图像。此类显示图像还可包括插入患者头部(H)中的器械的图形表示,使得操作者可实时查看器械在其实际位置的虚拟渲染。仅以举例的方式,显示屏(56)可根据2019年11月5日公布的名称为“GuidewireNavigation for Sinuplasty”的美国专利10,463,242号的教导内容中的至少一些教导内容来提供图像。在操作者还使用内窥镜的情况下,也可在显示屏(56)上提供内窥镜图像。The processor (52) uses software stored in the memory of the processor (52) to calibrate and operate the IGS navigation system (50). Such operations include driving the field generator (64), processing data from the instrument, processing data from the operating controls (54), and driving the display screen (56). In some implementations, operations may also include monitoring and enforcing one or more safety features or functions of the IGS navigation system (50). The processor (52) is further operable to provide real-time video via the display screen (56) showing a camera image of the distal end of the instrument relative to the patient's head (H), a CT scan image of the patient's head (H), and or the location of a computer-generated three-dimensional model of the anatomy within and adjacent to the patient's nasal cavity. The display screen (56) may display such images simultaneously and/or superimposed on each other during the surgical procedure. Such display images may also include graphical representations of instruments inserted into the patient's head (H), allowing the operator to view a virtual rendering of the instrument in its actual position in real time. By way of example only, the display screen (56) may provide images in accordance with at least some of the teachings of U.S. Patent No. 10,463,242, "Guidewire Navigation for Sinuplasty," issued on November 5, 2019. In situations where the operator is also using an endoscope, the endoscopic image may also be provided on the display screen (56).

通过显示屏(56)提供的图像可帮助引导操作者在患者头部(H)内调转并以其他方式操纵器械。还应当理解,如下所述的外科器械的其他部件以及其他种类的外科器械可结合导航传感器(如上文所述的导航传感器)。The images provided through the display screen (56) can help guide the operator to maneuver and otherwise manipulate the instrument within the patient's head (H). It will also be appreciated that other components of surgical instruments as described below, as well as other types of surgical instruments, may incorporate navigation sensors such as those described above.

II.带有柔性导航传感器组件的示例性ENT器械II. Exemplary ENT Device with Flexible Navigation Sensor Assembly

在一些情况下,可能期望提供用于ENT器械的柔性导航传感器组件(例如,印刷电路板)作为传统线圈传感器的替代物,以便于简化和/或较低成本的传感器制造和校准、减小传感器大小和/或轮廓、和/或改进传感器与各种不同类型的ENT器械的集成。下文所述的示例性柔性导航传感器组件(110,210,410,510,610)中的每一者可以这种方式起作用。虽然下面提供的示例是在各种特定ENT器械(100,400,500,600,700)的情况下讨论的,但是柔性导航传感器组件(110,210,410,510,610)可用于向任何其他合适的ENT器械提供导航能力。参考本文的教导内容,可使用的柔性导航传感器组件(110,210,410,510,610)的其他合适方式对于本领域的技术人员而言将是显而易见的。还应当理解,下文所述的所有柔性电路印刷电路板(PCB)和其他柔性电路特征部可包括仅一个单层或多个层。In some cases, it may be desirable to provide flexible navigation sensor assemblies (e.g., printed circuit boards) for ENT devices as an alternative to traditional coil sensors to facilitate simplified and/or lower cost sensor manufacturing and calibration, sensor reduction size and/or contour, and/or improve sensor integration with various types of ENT devices. Each of the exemplary flexible navigation sensor assemblies (110, 210, 410, 510, 610) described below may function in this manner. Although the examples provided below are discussed in the context of various specific ENT devices (100, 400, 500, 600, 700), the flexible navigation sensor assembly (110, 210, 410, 510, 610) may be used to provide navigation capabilities to any other suitable ENT device. Other suitable ways in which the flexible navigation sensor assembly (110, 210, 410, 510, 610) may be used will be apparent to those skilled in the art in view of the teachings herein. It should also be understood that all flexible circuit printed circuit boards (PCBs) and other flexible circuit features described below may include only a single layer or multiple layers.

A.带有矩形、双层柔性导航传感器组件的示例性器械A. Exemplary instrument with rectangular, dual-layer flexible navigation sensor assembly

图2至图13示出了器械(100)的示例,该器械可用于将扩张导管引导到解剖通道中以由此扩张解剖通道、将其他器械引导到解剖通道中并且/或者将RF能量递送到解剖通道中或附近的组织。例如,器械(100)可用于鼻旁窦口的扩张(例如,以治疗鼻窦炎)、喉扩张、咽鼓管扩张、耳、鼻或喉内其他通道的扩张等。另外或另选地,器械(100)可用于消融神经(例如,后鼻神经);消融鼻甲;或消融、电穿孔(例如,以促进治疗剂的吸收等),或将电阻加热施加到患者头部中的任何其他种类的解剖结构。Figures 2-13 illustrate an example of an instrument (100) that can be used to guide a dilation catheter into an anatomical channel to thereby dilate an anatomical channel, guide other instruments into an anatomical channel, and/or deliver RF energy to Tissues in or near dissection channels. For example, the device (100) may be used for dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilation, Eustachian tube dilation, ear, nose, or other passages within the larynx, and the like. Additionally or alternatively, the instrument (100) may be used to ablate a nerve (e.g., posterior nasal nerve); ablate turbinates; or ablate, electroporate (e.g., to facilitate absorption of therapeutic agents, etc.), or apply resistive heating to the patient's head any other kind of anatomical structure in the body.

该示例的器械(100)包括柄部组件(102)、轴组件(104)以及具有可视化和冲洗组件(108)和导航传感器组件(110)的导航、可视化和冲洗组件(106)。器械(100)可与充胀流体源(未示出)耦接,该充胀流体源能够操作以选择性地将充胀流体供应到设置在器械(100)中的扩张导管(未示出)的球囊,用于使球囊充胀,从而扩张解剖通道。另外或另选地,器械(100)可与RF发生器(101)耦接,该RF发生器能够操作以生成用于经由位于轴组件(104)的远侧端部处的电极(121,122)递送到组织的RF电外科能量,从而对组织进行消融、电穿孔或施加电阻加热。The example instrument (100) includes a handle assembly (102), a shaft assembly (104), and a navigation, visualization, and irrigation assembly (106) having a visualization and irrigation assembly (108) and a navigation sensor assembly (110). Instrument (100) may be coupled with a source of inflation fluid (not shown) operable to selectively supply inflation fluid to a dilation catheter (not shown) disposed in instrument (100) The balloon is used to inflate the balloon to expand the anatomical passage. Additionally or alternatively, the instrument (100) may be coupled with an RF generator (101) operable to generate electricity for delivery via the electrodes (121, 122) located at the distal end of the shaft assembly (104). RF electrosurgical energy is delivered to tissue to ablate, electroporate, or apply resistive heating to the tissue.

这个示例的柄部组件(102)包括主体(112)和至少一个滑块(114)。主体(112)的大小和构型被设置成由操作者的单手抓握和操作,诸如经由电动握把、铅笔握把或任何其他合适种类的握把。滑块(114)能够操作以相对于主体(112)纵向平移。滑块(114)与导丝或导管(例如,扩张导管或能量导管)(未示出)中的至少一者耦接,并且因此能够操作以纵向地平移此类导丝或导管。在一些型式中,另一滑块(未示出)可能够操作以纵向地平移导丝或导管的另一者。The handle assembly (102) of this example includes a body (112) and at least one slider (114). The body (112) is sized and configured to be grasped and operated with one hand of an operator, such as via an electric grip, pencil grip, or any other suitable kind of grip. The slider (114) is operable to translate longitudinally relative to the body (112). The slider (114) is coupled to at least one of a guidewire or catheter (eg, a dilation catheter or an energy catheter) (not shown) and is therefore operable to longitudinally translate such guidewire or catheter. In some versions, another slider (not shown) may be operable to longitudinally translate the other of the guidewire or catheter.

本示例的轴组件(104)包括刚性部分(116)、在刚性部分(116)远侧的柔性部分(118)和开口远侧端部(120)。牵引丝(未示出)与柔性部分(118)以及柄部组件(102)的偏转控制旋钮(122)耦接。偏转控制旋钮(122)能够相对于主体(112)围绕垂直于轴组件(104)的纵向轴线的轴线旋转,以选择性地朝近侧回缩牵引丝。当牵引丝朝近侧回缩时,柔性部分(118)弯曲并且由此使远侧端部(120)侧向偏转远离刚性部分(116)的纵向轴线。偏转控制旋钮(122)、牵引丝和柔性部分(118)因此协作以赋予轴组件(104)可转向性。仅以举例的方式,轴组件(104)的此类可转向性可根据以下美国专利申请的教导内容中的至少一些教导内容进行提供:2020年5月22日提交的名称为“Shaft Deflection Control Assembly forENT Guide Instrument”的美国专利申请63/028,609号。其他型式可提供一些其他种类的使用者输入特征部,而不是偏转控制旋钮(122)来驱动柔性部分(118)的转向。在一些另选型式中,偏转控制旋钮(122)被省略,并且柔性部分(118)是能够延展的。在仍其他型式中,轴组件(104)的整个长度是刚性的。The shaft assembly (104) of this example includes a rigid portion (116), a flexible portion (118) distal to the rigid portion (116), and an open distal end (120). A pull wire (not shown) is coupled to the flexible portion (118) and the deflection control knob (122) of the handle assembly (102). Deflection control knob (122) is rotatable relative to body (112) about an axis perpendicular to the longitudinal axis of shaft assembly (104) to selectively retract the pull wire proximally. As the pull wire is retracted proximally, the flexible portion (118) bends and thereby deflects the distal end (120) laterally away from the longitudinal axis of the rigid portion (116). The deflection control knob (122), pull wire, and flexible portion (118) thus cooperate to impart steerability to the shaft assembly (104). By way of example only, such steerability of the shaft assembly (104) may be provided in accordance with at least some of the teachings of the following U.S. patent application, entitled "Shaft Deflection Control Assembly" filed on May 22, 2020 forENT Guide Instrument” U.S. Patent Application No. 63/028,609. Other versions may provide some other kind of user input feature other than the deflection control knob (122) to drive the steering of the flexible portion (118). In some alternatives, the deflection control knob (122) is omitted and the flexible portion (118) is extensible. In still other versions, the shaft assembly (104) is rigid throughout its length.

轴组件(104)也能够相对于柄部组件(102)围绕刚性部分(116)的纵向轴线旋转。此类旋转可经由旋转控制旋钮(124)驱动,该旋转控制旋钮与柄部组件(102)的主体(112)可旋转地耦接。另选地,轴组件(104)可经由一些其他形式的使用者输入来旋转;或者可相对于柄部组件(102)不可旋转。还应当理解,本文所述的柄部组件(102)的示例仅是例示性示例。轴组件(104)可替代地与任何其他合适种类的柄部组件或其他支撑主体耦接。The shaft assembly (104) is also rotatable relative to the handle assembly (102) about the longitudinal axis of the rigid portion (116). Such rotation may be driven via a rotary control knob (124) that is rotatably coupled to the body (112) of the handle assembly (102). Alternatively, shaft assembly (104) may be rotatable via some other form of user input; or may be non-rotatable relative to handle assembly (102). It should also be understood that the examples of handle assembly (102) described herein are illustrative examples only. The shaft assembly (104) may alternatively be coupled with any other suitable kind of handle assembly or other support body.

如图3最佳所示,导航、可视化和冲洗组件(106)设置在轴组件(104)内并且能够操作以向轴组件(104)提供导航能力,并且在位于轴组件(104)的远侧端部120远侧的目标组织部位处提供可视化和冲洗。As best shown in Figure 3, the navigation, visualization and irrigation assembly (106) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104) and is located distally of the shaft assembly (104). Visualization and irrigation are provided at the target tissue site distal to tip 120.

就这一点而言,导航、可视化和冲洗组件(106)的导航传感器组件(110)设置在轴组件(104)内并且能够操作以向轴组件(104)提供导航能力。更具体地,导航传感器组件(110)横跨轴组件(104)的柔性部分(118)的内径大致水平地延伸穿过其中心,并且具有大致平坦(例如,平面)的构型。In this regard, the navigation sensor assembly (110) of the navigation, visualization and flushing assembly (106) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104). More specifically, the navigation sensor assembly (110) extends generally horizontally through its center across the inner diameter of the flexible portion (118) of the shaft assembly (104) and has a generally flat (eg, planar) configuration.

现在参考图4至图11,该示例的导航传感器组件(110)以柔性印刷电路板(PCB)的形式提供,并且包括细长的、大致矩形的柔性电路基板(126),该柔性电路基板上形成(例如,印刷和/或嵌入)有多个迹线(130,132,134,136)、多个对应的迹线引线(例如,焊盘)(138a,138b,138c,138d)以及多个接地引线(139a,139b,139c,139d)。如图所示,基板(126)在近侧端部与远侧端部(140,141)之间纵向延伸,在第一侧与第二侧(142,143)之间侧向延伸,并且在顶部表面与底部表面(144,145)之间竖直延伸。本示例的基板(126)包括在顶部表面与底部表面(144,145)之间延伸的一对通孔(146)。通孔(146)可被构造成接纳相应的销(未示出)或其他合适的紧固件,以将导航传感器组件(110)固定到轴组件(104)的柔性部分(118)和/或器械(100)的任何其他部件,诸如可视化和冲洗组件(108)。在所示型式中,基板(126)还包括在近侧端部(140)与第二侧面(143)之间延伸的近侧斜面(148)。近侧斜面(148)可被构造成有助于将近侧端部(140)定位在相对于轴组件(104)的柔性部分(118)和/或相对于器械(100)的任何其他部件(诸如可视化和冲洗组件(108))的期望位置处。Referring now to FIGS. 4-11 , the navigation sensor assembly (110) of this example is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (126) on which Forming (eg, printed and/or embedded) a plurality of traces (130, 132, 134, 136), a plurality of corresponding trace leads (eg, pads) (138a, 138b, 138c, 138d), and a plurality of ground leads (139a, 139b ,139c,139d). As shown, the base plate (126) extends longitudinally between the proximal and distal ends (140, 141), laterally between the first and second sides (142, 143), and between the top surface and the bottom surface. Extend vertically between surfaces (144,145). The substrate (126) of this example includes a pair of through holes (146) extending between top and bottom surfaces (144, 145). The through hole (146) may be configured to receive a corresponding pin (not shown) or other suitable fastener to secure the navigation sensor assembly (110) to the flexible portion (118) of the shaft assembly (104) and/or Any other components of the instrument (100), such as visualization and irrigation components (108). In the version shown, the base plate (126) also includes a proximal ramp (148) extending between the proximal end (140) and the second side (143). The proximal ramp (148) may be configured to facilitate positioning the proximal end (140) relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other components of the instrument (100) such as Visualize and rinse component (108)) at the desired location.

基板(126)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或液晶聚合物(LCP)。例如,在期望维持基板(126)的相对平坦构型的情况下,基板(126)可由聚酰亚胺形成,因为由聚酰亚胺形成的此类基板(126)可朝向自然平坦构型弹性地偏置。另选地,在期望基板(126)的更复杂几何构型和/或增加的柔性的情况下,基板(126)可由LCP形成,因为由LCP形成的基板(126)可被热成形以适应此类复杂几何形状和/或提供增加的柔性,如下文所述。在任何情况下,迹线(130,132,134,136)、引线(138a,138b,138c,138d)和接地引线(139a,139b,139c,139d)均可由诸如铜的导电金属材料形成。导航传感器组件(110)的大小合适地被设置成适配在轴组件(104)内,同时仍然准许用于工作通道(149)沿轴组件(104)延伸(例如,在导航传感器组件(110)上方)的空间,从而准许附加器械(例如,扩张导管和/或能量导管)、抽吸、流体等穿过邻近导航传感器组件(110)的开口远侧端部(120)。就这一点而言,至少与传统的线圈传感器相比,导航传感器组件(110)可具有相对低轮廓。在一些型式中,导航传感器组件(110)可具有大约50微米的厚度。Substrate (126) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (126), the substrate (126) may be formed from polyimide because such a substrate (126) formed from polyimide may be resilient toward a naturally flat configuration. Ground offset. Alternatively, where more complex geometries and/or increased flexibility of substrate (126) are desired, substrate (126) may be formed from LCP, as substrate (126) formed from LCP may be thermoformed to accommodate this. class complex geometries and/or provide increased flexibility, as discussed below. In any case, traces (130, 132, 134, 136), leads (138a, 138b, 138c, 138d), and ground leads (139a, 139b, 139c, 139d) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (110) is appropriately sized to fit within the shaft assembly (104) while still allowing for a working channel (149) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (110) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (110). In this regard, the navigation sensor assembly (110) may have a relatively low profile, at least compared to conventional coil sensors. In some versions, navigation sensor assembly (110) may have a thickness of approximately 50 microns.

如图4和图5所示,迹线(130,132,134,136)包括各自形成在基板(126)的顶部表面(144)上的近侧顶部迹线(130)和远侧顶部迹线(132),以及各自形成在基板(126)的底部表面(145)上的与对应的顶部迹线(130,132)相对和/或平行的近侧底部迹线(134)和远侧底部迹线(136)。类似地,引线(138a,138b,138c,138d)包括各自形成在基板(126)的顶部表面(144)上的第一顶部引线和第二顶部引线(138a,138b),以及各自形成在基板(126)的底部表面(145)上的与对应的顶部引线(138a,138b)相对和/或平行的第一底部引线和第二底部引线(138c,138d)。接地引线(139a,139b,139c,139d)包括各自形成在基板(126)的顶部表面(144)上的第一顶部接地引线和第二顶部接地引线(139a,139b),以及各自形成在基板(126)的底部表面(145)上的第一底部接地引线和第二底部接地引线(139c,139d)。顶部迹线(130,132)、顶部引线(138a,138b)和顶部接地引线(139a,139b)共同限定导航传感器组件(110)的顶部柔性电路层,而底部迹线(134,136)、底部引线(138c,138d)和底部接地引线(139c,139d)共同限定导航传感器组件(110)的底部柔性电路层。As shown in FIGS. 4 and 5 , traces ( 130 , 132 , 134 , 136 ) include proximal top traces ( 130 ) and distal top traces ( 132 ), each formed on a top surface ( 144 ) of substrate ( 126 ), and respective Proximal bottom traces (134) and distal bottom traces (136) are formed on the bottom surface (145) of the substrate (126) opposite and/or parallel to corresponding top traces (130, 132). Similarly, leads (138a, 138b, 138c, 138d) include first and second top leads (138a, 138b) each formed on the top surface (144) of the substrate (126), and each formed on the substrate (126). First and second bottom leads (138c, 138d) on the bottom surface (145) of 126) that are opposite and/or parallel to the corresponding top leads (138a, 138b). Ground leads (139a, 139b, 139c, 139d) include first and second top ground leads (139a, 139b) each formed on the top surface (144) of the substrate (126), and each formed on the substrate (126). First bottom ground lead and second bottom ground lead (139c, 139d) on the bottom surface (145) of 126). Top traces (130,132), top leads (138a, 138b), and top ground leads (139a, 139b) collectively define the top flex circuit layer of the navigation sensor assembly (110), while bottom traces (134,136), bottom leads (138c, 138d) and bottom ground leads (139c, 139d) together define the bottom flexible circuit layer of the navigation sensor assembly (110).

现在参考图6至图11,迹线(130,132,134,136)各自包括相应的第一纵向部分(130a,132a,134a,136a)、同心环部分(130b,132b,134b,136b)和第二纵向部分(130c,132c,134c,136c)。如图所示,远侧迹线(132,136)的同心环部分(132b,136b)相对于相应近侧迹线(130,134)的同心环部分(130b,134b)定位在远侧。Referring now to Figures 6-11, traces (130, 132, 134, 136) each include respective first longitudinal portions (130a, 132a, 134a, 136a), concentric ring portions (130b, 132b, 134b, 136b) and second longitudinal portions (130c ,132c,134c,136c). As shown, the concentric ring portions (132b, 136b) of the distal traces (132, 136) are positioned distally relative to the concentric ring portions (130b, 134b) of the corresponding proximal traces (130, 134).

第一顶部引线(138a)电耦接到近侧顶部迹线(130)的第一纵向部分(130a)的近侧端部。近侧顶部迹线(130)的第一纵向部分(130a)从其近侧端部朝远侧延伸,并且在其远侧端部处通过对应的通孔电耦接到近侧底部迹线(134)的第一纵向部分(134a)的远侧端部。近侧底部迹线(134)的第一纵向部分(134a)从其远侧端部朝向第一底部引线(138c)朝近侧延伸,并且在其近侧端部处电耦接到近侧底部迹线(134)的第二纵向部分(134c)的近侧端部。近侧底部迹线(134)的第二纵向部分(134c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到近侧底部迹线(134)的同心环部分(134b)的径向外端。近侧底部迹线(134)的同心环部分(134b)从其径向外端径向向内螺旋,并且在其径向内端处通过对应的通孔电耦接到近侧顶部迹线(130)的同心环部分(130b)的径向内端。近侧顶部迹线(130)的同心环部分(130b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到近侧顶部迹线(130)的第二纵向部分(130c)的远侧端部。近侧顶部迹线(130)的第二纵向部分(130c)从其远侧端部朝向第一顶部引线(138b)朝近侧延伸,并且在其近侧端部处通过对应的通孔电耦接到第一底部引线(138c)。The first top lead (138a) is electrically coupled to the proximal end of the first longitudinal portion (130a) of the proximal top trace (130). A first longitudinal portion (130a) of the proximal top trace (130) extends distally from its proximal end and is electrically coupled at its distal end to the proximal bottom trace (130a) through a corresponding via hole. The distal end of the first longitudinal portion (134a) of 134). A first longitudinal portion (134a) of the proximal bottom trace (134) extends proximally from its distal end toward the first bottom lead (138c) and is electrically coupled to the proximal bottom at its proximal end The proximal end of the second longitudinal portion (134c) of the trace (134). A second longitudinal portion (134c) of the proximal bottom trace (134) extends distally from a proximal end thereof and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (134) Radially outer end of portion (134b). The concentric ring portion (134b) of the proximal bottom trace (134) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the proximal top trace (134b) through corresponding vias. The radially inner end of the concentric ring portion (130b) of 130). The concentric ring portion (130b) of the proximal top trace (130) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (130b) of the proximal top trace (130). The distal end of the longitudinal portion (130c). A second longitudinal portion (130c) of the proximal top trace (130) extends proximally from its distal end toward the first top lead (138b) and is electrically coupled at its proximal end by a corresponding via Connect to the first bottom lead (138c).

第二顶部引线(138b)电耦接到远侧顶部迹线(132)的第一纵向部分(132a)的近侧端部。远侧顶部迹线(132)的第一纵向部分(132a)从其近侧端部朝远侧延伸,并且在其远侧端部处通过对应的通孔电耦接到远侧底部迹线(136)的第一纵向部分(136a)的远侧端部。远侧底部迹线(136)的第一纵向部分(136a)从其远侧端部朝向第二底部引线(138d)朝近侧延伸,并且在其近侧端部处电耦接到远侧底部迹线(136)的第二纵向部分(136c)的近侧端部。远侧底部迹线(136)的第二纵向部分(136c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到远侧底部迹线(136)的同心环部分(136b)的径向外端。远侧底部迹线(136)的同心环部分(136b)从其径向外端径向向内螺旋,并且在其径向内端处通过对应的通孔电耦接到远侧顶部迹线(132)的同心环部分(132b)的径向内端。远侧顶部迹线(132)的同心环部分(132b)从其径向内端径向向外螺旋,并且在其径向外端电耦接到远侧顶部迹线(132)的第二纵向部分(132c)的远侧端部。远侧顶部迹线(132)的第二纵向部分(132c)从其远侧端部朝向第二顶部引线(138b)朝近侧延伸,并且在其近侧端部处通过对应的通孔电耦接到第二底部引线(138d)。The second top lead (138b) is electrically coupled to the proximal end of the first longitudinal portion (132a) of the distal top trace (132). A first longitudinal portion (132a) of the distal top trace (132) extends distally from its proximal end and is electrically coupled at its distal end to the distal bottom trace (132a) through a corresponding via hole. The distal end of the first longitudinal portion (136a) of 136). A first longitudinal portion (136a) of the distal bottom trace (136) extends proximally from a distal end thereof toward a second bottom lead (138d) and is electrically coupled to the distal bottom at a proximal end thereof The proximal end of the second longitudinal portion (136c) of the trace (136). A second longitudinal portion (136c) of the distal bottom trace (136) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of the distal bottom trace (136) Radially outer end of portion (136b). The concentric ring portion (136b) of the distal bottom trace (136) spirals radially inward from its radially outer end and is electrically coupled at its radially inner end to the distal top trace (136b) through corresponding vias. The radially inner end of the concentric ring portion (132b) of 132). The concentric ring portion (132b) of the distal top trace (132) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second longitudinal direction of the distal top trace (132) The distal end of portion (132c). A second longitudinal portion (132c) of the distal top trace (132) extends proximally from its distal end toward the second top lead (138b) and is electrically coupled at its proximal end by a corresponding via Connect to second bottom lead (138d).

因此,电流可大致沿第一顶部引线(138a)流向近侧顶部迹线(130)的第一纵向部分(130a)、流向近侧底部迹线(134)的第一纵向部分(134a)、流向近侧底部迹线(134)的第二纵向部分(134c)、流向近侧底部迹线(134)的同心环部分(134b)、流向近侧顶部迹线(130)的同心环部分(130b)、流向近侧顶部迹线(130)的第二纵向部分(130c)、流向第一底部引线(138c)。另选地,电流可大致沿第一底部引线(138c)流向近侧顶部迹线(130)的第二纵向部分(130c)、流向近侧顶部迹线(130)的同心环部分(130b)、流向近侧底部迹线(134)的同心环部分(134b)、流向近侧底部迹线(134)的第二纵向部分(134c)、流向近侧底部迹线(134)的第一纵向部分(134a)、流向近侧顶部迹线(130)的第一纵向部分(130a)、流向第一顶部引线(138a)。Accordingly, current may flow generally along first top lead (138a) to first longitudinal portion (130a) of proximal top trace (130), to first longitudinal portion (134a) of proximal bottom trace (134), to Second longitudinal portion (134c) of proximal bottom trace (134), concentric ring portion (134b) flowing to proximal bottom trace (134), concentric ring portion (130b) flowing to proximal top trace (130) , to the second longitudinal portion (130c) of the proximal top trace (130), to the first bottom lead (138c). Alternatively, current may flow generally along the first bottom lead (138c) to the second longitudinal portion (130c) of the proximal top trace (130), to the concentric ring portion (130b) of the proximal top trace (130), Concentric ring portion (134b) flowing to the proximal bottom trace (134), second longitudinal portion (134c) flowing to the proximal bottom trace (134), first longitudinal portion (134) flowing to the proximal bottom trace (134) 134a), to the first longitudinal portion (130a) of the proximal top trace (130), to the first top lead (138a).

同样,电流可大致沿第二顶部引线(138b)流向远侧顶部迹线(132)的第一纵向部分(132a)、流向远侧底部迹线(136)的第一纵向部分(136a)、流向远侧底部迹线(136)的第二纵向部分(136c)、流向远侧底部迹线(136)的同心环部分(136b)、流向远侧顶部迹线(132)的同心环部分(132b)、流向远侧顶部迹线(132)的第二纵向部分(132c)、流向第二底部引线(138d)。另选地,电流可大致沿第二底部引线(138d)流向远侧顶部迹线(132)的第二纵向部分(132c)、流向远侧顶部迹线(132)的同心环部分(132b)、流向远侧底部迹线(136)的同心环部分(136b)、流向远侧底部迹线(136)的第二纵向部分(136c)、流向远侧底部迹线(136)的第一纵向部分(136a)、流向远侧顶部迹线(132)的第一纵向部分(132a)、流向第二顶部引线(138b)。Likewise, current may flow generally along second top lead (138b) to first longitudinal portion (132a) of distal top trace (132), to first longitudinal portion (136a) of distal bottom trace (136), to Second longitudinal portion (136c) of distal bottom trace (136), concentric ring portion (136b) flowing to distal bottom trace (136), concentric ring portion (132b) flowing to distal top trace (132) , to the second longitudinal portion (132c) of the distal top trace (132), to the second bottom lead (138d). Alternatively, current may flow generally along the second bottom lead (138d) to the second longitudinal portion (132c) of the distal top trace (132), to the concentric ring portion (132b) of the distal top trace (132), Concentric ring portion (136b) flowing to the distal bottom trace (136), second longitudinal portion (136c) flowing to the distal bottom trace (136), first longitudinal portion (136) flowing to the distal bottom trace (136) 136a), to the first longitudinal portion (132a) of the distal top trace (132), to the second top lead (138b).

当同心环部分(130b,132b,134b,136b)定位在由场发生器(64)生成的交变电磁场内时,交变磁场可在同心环部分(130b,132b,134b,136b)中生成电流,并且此电流可沿相应纵向部分(130a,132a,134a,136a、130c,132c,134c,136c)诸如经由电耦接到引线(138a,138b,138c,138d)的耦接单元(未示出)传送到处理器(52)。这样,每个同心环部分(130b,132b,134b,136b)限定相应的导航传感器(150,152,154,156),该导航传感器能够操作以生成指示相应的导航传感器(150,152,154,156)的位置并且由此指示器械(100)的至少一部分(例如,轴组件(104)的柔性部分(118))在三维空间中的位置的信号。由此类位置相关信号生成的位置数据可由处理器(52)处理以用于向操作者提供视觉指示以实时地向操作者显示器械(100)的轴组件(104)在患者(P)体内所位于的位置。此类视觉指示可被提供为在患者解剖结构的一个或多个术前获得的图像(例如,CT扫描)上的叠加。When the concentric ring portions (130b, 132b, 134b, 136b) are positioned within the alternating electromagnetic field generated by the field generator (64), the alternating magnetic field can generate electrical current in the concentric ring portions (130b, 132b, 134b, 136b) , and this current can flow along the respective longitudinal portions (130a, 132a, 134a, 136a, 130c, 132c, 134c, 136c) such as via coupling units (not shown) electrically coupled to the leads (138a, 138b, 138c, 138d) ) is sent to the processor (52). Thus, each concentric ring portion (130b, 132b, 134b, 136b) defines a respective navigation sensor (150, 152, 154, 156) operable to generate an indication of the position of the respective navigation sensor (150, 152, 154, 156) and thereby the instrument (100) A signal indicating the position in three-dimensional space of at least a portion of the shaft assembly (104), such as the flexible portion (118) of the shaft assembly (104). Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator in real time where the shaft assembly (104) of the instrument (100) is located within the patient (P). Located in the location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

在所示示例中,远侧导航传感器(152,156)定位在轴组件(104)的远侧端部(120)处或附近以便于远侧端部(120)的导航,而近侧导航传感器(150,154)可定位在柔性部分(118)的近侧端部处或附近以有助于识别例如柔性部分(118)的方向和/或取向。仅以进一步示例的方式,远侧导航传感器(152,156)可定位在柔性部分(118)的远侧区中,使得当远侧端部(120)侧向偏转远离刚性部分(116)的纵向轴线时,远侧导航传感器(152,156)侧向偏转远离刚性部分(116)的纵向轴线。相反地,近侧导航传感器(150,154)可定位在柔性部分(118)的近侧,使得当远侧端部(120)侧向偏转远离刚性部分(116)的纵向轴线时,近侧导航传感器(150,154)不会侧向偏转远离刚性部分(116)的纵向轴线。在此类场景下,可将来自近侧导航传感器(150,154)的位置数据与来自远侧导航传感器(152,156)的位置数据进行比较,以精确地确定远侧端部(120)相对于IGS导航系统(50)的参照系的侧向偏转程度。当然,导航传感器(150,152,154,156)可定位在相对于需要导航的器械(100)的部件的任何其他合适的位置处;并且可以任何其他合适的方式来使用。In the example shown, the distal navigation sensors (152, 156) are positioned at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120), while the proximal navigation sensors (150, 154 ) may be positioned at or near the proximal end of flexible portion (118) to aid in identifying, for example, the direction and/or orientation of flexible portion (118). By way of further example only, distal navigation sensors (152, 156) may be positioned in a distal region of flexible portion (118) such that when distal end (120) deflects laterally away from the longitudinal axis of rigid portion (116) , the distal navigation sensors (152, 156) are deflected laterally away from the longitudinal axis of the rigid portion (116). Conversely, the proximal navigation sensor (150, 154) may be positioned proximal to the flexible portion (118) such that when the distal end (120) deflects laterally away from the longitudinal axis of the rigid portion (116), the proximal navigation sensor (154) 150, 154) will not deflect laterally away from the longitudinal axis of the rigid portion (116). In such scenarios, position data from the nearside navigation sensors (150, 154) can be compared to position data from the far side navigation sensors (152, 156) to accurately determine the distal end (120) relative to the IGS navigation system The degree of lateral deflection of the reference frame of (50). Of course, the navigation sensors (150, 152, 154, 156) may be positioned at any other suitable location relative to the components of the instrument (100) requiring navigation; and may be used in any other suitable manner.

在一些型式中,限定在基板(126)的近侧端部和远侧端部(140,141)之间的导航传感器组件(110)的长度可足够大以将远侧导航传感器(152,156)定位在轴组件(104)的远侧端部(120)处或附近以便于远侧端部(120)的导航,同时还将引线(138a,138b,138c,138d)定位在足够近侧的位置处,在该位置处引线(138a,138b,138c,138d)可直接电耦接到耦接单元(例如,无需插入电线或电缆)。就这一点而言,导航传感器组件(110)的长度可基本上等于或大于轴组件(104)的长度,使得引线(138a,138b,138c,138d)可定位在柄部组件(110)的主体(112)内或甚至相对于该柄部组件的该主体定位在近侧。例如,导航传感器组件(110)可具有大约数米的长度。这样,导航传感器组件(110)既可生成位置相关信号又可将位置相关信号传输到耦接单元,而不需要在该耦接单元之间布线电线或电缆。In some versions, the length of the navigation sensor assembly (110) defined between the proximal and distal ends (140, 141) of the base plate (126) may be large enough to position the distal navigation sensors (152, 156) on-axis. at or near the distal end (120) of the assembly (104) to facilitate navigation of the distal end (120) while also positioning the leads (138a, 138b, 138c, 138d) at a location sufficiently proximal to At this location the leads (138a, 138b, 138c, 138d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (110) can be substantially equal to or greater than the length of the shaft assembly (104) such that the leads (138a, 138b, 138c, 138d) can be positioned on the body of the handle assembly (110) (112) or even positioned proximally relative to the body of the handle assembly. For example, navigation sensor assembly (110) may be on the order of several meters in length. In this way, the navigation sensor assembly (110) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units.

应当了解,导航传感器(150,152,154,156)可各自以任何其他合适的方式配置以用于在定位于交变电磁场内时生成电流。例如,限定导航传感器(150,152,154,156)的每个同心环部分(130b,132b,134b,136b)的同心环的数量可大于或小于所示数量。另外或另选地,每个同心环部分(130b,132b,134b,136b)的任何一个或多个尺寸(例如,高度、宽度、长度和/或厚度)可大于或小于所示尺寸。虽然所示的同心环部分(130b,132b,134b,136b)均为大致矩形的,但同心环部分(130b,132b,134b,136b)均可具有任何其他合适的形状。例如,同心环部分(130b,132b,134b,136b)均可以是大致圆形的,并且可具有任何合适的直径。It will be appreciated that the navigation sensors (150, 152, 154, 156) may each be configured in any other suitable manner for generating electrical current when positioned within an alternating electromagnetic field. For example, the number of concentric rings defining each concentric ring portion (130b, 132b, 134b, 136b) of the navigation sensor (150, 152, 154, 156) may be greater or less than the number shown. Additionally or alternatively, any one or more dimensions (eg, height, width, length, and/or thickness) of each concentric ring portion (130b, 132b, 134b, 136b) may be larger or smaller than the dimensions shown. Although the concentric ring portions (130b, 132b, 134b, 136b) are shown as being generally rectangular, the concentric ring portions (130b, 132b, 134b, 136b) may have any other suitable shape. For example, the concentric ring portions (130b, 132b, 134b, 136b) may each be generally circular and may have any suitable diameter.

应当了解,顶部迹线(130,132)或底部迹线(134,136)单独可以能够将位置相关信号传送到处理器(52),并且通过底部迹线(134,136)传送到处理器(52)的位置相关信号因此对于通过顶部迹线(130,132)传送的那些位置相关信号可能是冗余的。此类冗余可通过验证由顶部迹线(130,132)传送的位置相关信号生成的位置数据来提高由顶部迹线(130,132)提供的位置相关信号的可靠性。另外或另选地,由顶部迹线(130,132)和底部迹线(134,136)传送的位置相关信号可用于确定轴组件(104)的柔性部分(118)的取向。It will be appreciated that the top traces (130, 132) or the bottom traces (134, 136) alone may be capable of carrying position-related signals to the processor (52), and the bottom traces (134, 136) may carry position-related signals to the processor (52) There may therefore be redundancy for those position related signals carried via the top traces (130, 132). Such redundancy may increase the reliability of the position-related signals provided by the top traces (130, 132) by validating the position data generated by the position-related signals carried by the top traces (130, 132). Additionally or alternatively, position-related signals conveyed by top traces (130, 132) and bottom traces (134, 136) may be used to determine the orientation of the flexible portion (118) of the shaft assembly (104).

在一些型式中,顶部迹线(130,132)相对于对应的底部迹线(134,136)的相对布置可有助于实质上减少或消除电磁干扰或“噪声”(其可另外由由于引线(138a,138b,138c,138d)没有通常存在于传统线圈传感器布置中的的双绞线而在迹线(130,132,134,136)中流动的电流引起),以由此提高传送到处理器(52)的位置相关信号的准确性和可靠性。如图12示意性所示,电流可在顶部迹线(130,132)中沿第一方向流动,并且可在对应的底部迹线(134,136)中沿与第一方向相反且平行的第二方向流动。例如,电流可在顶部同心环部分(130b、132b)中沿第一方向(例如,顺时针或逆时针中的一者)流动,并且可在对应的底部同心环部分(134b,136b)中沿与第一方向相反且平行的第二方向(例如,顺时针或逆时针中的另一者)流动。同样,电流可在顶部纵向部分(130a,132a,130c,132c)中沿第一方向(例如,近侧或远侧中的一者)流动,并且可在对应的底部纵向部分(134a,136a,134c,136c)中沿与第一方向相反且平行的第二方向(例如,近侧或远侧中的另一者)流动。在顶部迹线(130,132)中沿第一方向流动的电流和在对应的底部迹线(134,136)中沿第二方向流动的电流可具有彼此基本上相同的量值。因此,由顶部迹线(130,132)中的电流引起的磁场噪声和由对应的底部迹线(134,136)中的电流引起的磁场噪声可基本上相等并且彼此相反,使得磁场噪声彼此抵消并且由此两者都被基本上减少或消除。因此,虽然顶部柔性电路层或底部柔性电路层单独可以能够提供位置相关信号,但是具有两个层的冗余可提供降噪益处。在一些型式中,可提供更多或更少的柔性电路层。例如,可省略顶部柔性电路层或底部柔性电路层。In some versions, the relative arrangement of top traces (130, 132) relative to corresponding bottom traces (134, 136) may help to substantially reduce or eliminate electromagnetic interference or "noise" (which may otherwise be caused by leads (138a, 138b) , 138c, 138d) caused by the current flowing in the traces (130, 132, 134, 136) without the twisted pairs typically present in conventional coil sensor arrangements, to thereby increase the accuracy of the position-related signals transmitted to the processor (52) performance and reliability. As schematically shown in Figure 12, current may flow in a first direction in the top traces (130, 132) and in a second direction opposite and parallel to the first direction in the corresponding bottom traces (134, 136). For example, current may flow in a first direction (eg, one of clockwise or counterclockwise) in the top concentric ring portions (130b, 132b) and in the corresponding bottom concentric ring portions (134b, 136b). A second direction (eg, the other of clockwise or counterclockwise) flows opposite and parallel to the first direction. Likewise, current may flow in a first direction (eg, one of proximal or distal) in the top longitudinal portions (130a, 132a, 130c, 132c) and may flow in the corresponding bottom longitudinal portions (134a, 136a, 134c, 136c) in a second direction (eg, the other of proximal or distal) that is opposite and parallel to the first direction. The current flowing in the first direction in the top traces (130, 132) and the current flowing in the second direction in the corresponding bottom traces (134, 136) may be of substantially the same magnitude as each other. Therefore, the magnetic field noise caused by the current in the top traces (130, 132) and the magnetic field noise caused by the current in the corresponding bottom traces (134, 136) may be substantially equal and opposite to each other, such that the magnetic field noise cancels each other and thus both have been largely reduced or eliminated. Therefore, while the top flex circuit layer or the bottom flex circuit layer alone may be able to provide position-dependent signals, having the redundancy of both layers may provide noise reduction benefits. In some versions, more or fewer flexible circuit layers may be provided. For example, the top flexible circuit layer or the bottom flexible circuit layer may be omitted.

在一些其他型式中,顶部引线(138a,138b)相对于对应的底部引线(138c,138d)的相对布置可有助于实质上减少或消除在迹线(130,132,134,136)的近侧端子处拾取的电磁噪声。例如,第一顶部引线(138a)的极性可与第一底部引线(138c)的极性相反,使得来自近侧顶部迹线(130)的近侧端子的任何拾取噪声和来自近侧底部迹线(134)的近侧端子的任何拾取噪声彼此抵消并且由此两者都被基本上减少或消除。同样,第二顶部引线(138b)的极性可与第二底部引线(138d)的极性相反,使得来自远侧顶部迹线(132)的近侧端子的任何拾取噪声和来自远侧底部迹线(136)的近侧端子的任何拾取噪声彼此抵消并且由此两者都被基本上减少或消除。In some other versions, the relative arrangement of top leads (138a, 138b) relative to corresponding bottom leads (138c, 138d) may help to substantially reduce or eliminate electromagnetic fields picked up at proximal terminals of traces (130, 132, 134, 136) noise. For example, the polarity of the first top lead (138a) may be opposite to the polarity of the first bottom lead (138c) such that any pickup noise from the proximal terminals of the proximal top trace (130) and from the proximal bottom trace Any pickup noise from the proximal terminals of line (134) cancels each other out and thereby both are substantially reduced or eliminated. Likewise, the polarity of the second top lead (138b) may be opposite to the polarity of the second bottom lead (138d) such that any pickup noise from the proximal terminals of the far top trace (132) and from the far bottom trace (132) Any pickup noise of the proximal terminals of line (136) cancels each other out and thereby both are substantially reduced or eliminated.

虽然本示例的导航传感器组件(110)包括单个远侧顶部导航传感器(152)和单个远侧底部导航传感器(156),但是导航传感器组件(110)可另选地包括多个远侧顶部导航传感器(152)和/或远侧底部导航传感器(156)。例如,导航传感器组件(110)可包括一对侧向相邻的远侧顶部导航传感器(152)和/或一对侧向相邻的远侧底部导航传感器(156)。此类一对远侧顶部导航传感器和/或远侧底部导航传感器(152,156)可有助于提高由处理器(52)根据导航传感器(150,152,154,156)的位置相关信号计算的轴组件(104)的柔性部分(118)的位置坐标的准确性。在一些情况下,导航传感器组件(110)可沿如下所述的轴组件(104)的柔性部分(118)的大致柱形表面设置,使得此类一对中的一个远侧顶部导航传感器和/或远侧底部导航传感器(152,156)可设置在轴组件(104)的柔性部分(118)的第一侧向侧上,并且此类一对中的另一个远侧顶部导航传感器和/或远侧底部导航传感器(152,156)可设置在轴组件(104)的柔性部分(118)的第二侧向侧上。这样,一对远侧顶部导航传感器和/或远侧底部导航传感器(152,156)可提供指示柔性部分(118)的两个侧向侧的位置的位置相关信号,这可提高由处理器(52)计算的位置坐标的准确性,诸如当柔性部分(118)处于弯曲构型时。While the navigation sensor assembly (110) of this example includes a single distal top navigation sensor (152) and a single distal bottom navigation sensor (156), the navigation sensor assembly (110) may alternatively include multiple distal top navigation sensors. (152) and/or the distal bottom navigation sensor (156). For example, navigation sensor assembly (110) may include a pair of laterally adjacent distal top navigation sensors (152) and/or a pair of laterally adjacent distal bottom navigation sensors (156). Such a pair of distal top navigation sensors and/or distal bottom navigation sensors (152, 156) may assist in increasing the flexibility of the shaft assembly (104) calculated by the processor (52) based on position-related signals from the navigation sensors (150, 152, 154, 156) The accuracy of the position coordinates of part (118). In some cases, navigation sensor assembly (110) may be disposed along a generally cylindrical surface of flexible portion (118) of shaft assembly (104) as described below such that one distal top navigation sensor and/or of such a pair Or the distal bottom navigation sensor (152, 156) may be disposed on a first lateral side of the flexible portion (118) of the shaft assembly (104), and the other distal top navigation sensor and/or distal of such a pair Bottom navigation sensors (152, 156) may be disposed on the second lateral side of the flexible portion (118) of the shaft assembly (104). In this manner, a pair of distal top navigation sensors and/or distal bottom navigation sensors (152, 156) may provide position-related signals indicative of the position of the two lateral sides of the flexible portion (118), which may enhance the processing by the processor (52) Accuracy of calculated position coordinates, such as when the flexible portion (118) is in a curved configuration.

虽然本示例的导航传感器组件(110)设置在轴组件(104)内使得导航传感器(150,152,154,156)能够操作以生成指示轴组件(104)的位置的信号,但是导航传感器组件(110)可另选地定位在器械(100)的任何其他部件上以生成指示此类其他部件的位置的信号。此外,虽然本示例的导航传感器组件(110)横跨轴组件(104)的柔性部分(118)的内径大致水平地延伸穿过其中心,并且具有大致平坦的构型,但是导航传感器组件(110)可另选地设置在轴组件(104)上或内的任何其他合适的位置处并且可具有任何其他合适的构型。例如,导航传感器组件(110)可横跨轴组件(104)的柔性部分(118)的任何合适的弦延伸。Although the navigation sensor assembly (110) of this example is disposed within the shaft assembly (104) such that the navigation sensors (150, 152, 154, 156) are operable to generate signals indicative of the position of the shaft assembly (104), the navigation sensor assembly (110) may alternatively Positioning on any other component of the instrument (100) to generate a signal indicative of the location of such other component. Additionally, while the navigation sensor assembly (110) of this example extends generally horizontally through its center across the inner diameter of the flexible portion (118) of the shaft assembly (104) and has a generally flat configuration, the navigation sensor assembly (110 ) may alternatively be disposed at any other suitable location on or within the shaft assembly (104) and may have any other suitable configuration. For example, navigation sensor assembly (110) may extend across any suitable chord of flexible portion (118) of shaft assembly (104).

如图13所示,导航传感器组件(110)可沿轴组件(104)的柔性部分(118)的大致柱形内表面设置在可视化和冲洗组件(108)下方并且可具有大致弯曲构型,使得导航传感器组件(110)围绕轴组件(104)的柔性部分(118)的纵向轴线以对应于柱形内表面的曲率半径的曲率半径弯曲,以由此适形于柔性部分(118)的内圆周。在该构型中,导航传感器组件(110)可准许用于较大的工作通道(149a)沿轴组件(104)(例如,在可视化和冲洗组件108上方)延伸的相对更多的空间。另选地,导航传感器组件(110)可沿轴组件(104)的柔性部分(118)的大致柱形外表面设置并且可具有大致弯曲构型,使得导航传感器组件(110)围绕轴组件(104)的柔性部分(118)的纵向轴线以对应于柱形外表面的曲率半径的曲率半径弯曲,以由此适形于柔性部分(118)的外圆周。As shown in Figure 13, the navigation sensor assembly (110) may be disposed beneath the visualization and irrigation assembly (108) along a generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) and may have a generally curved configuration such that The navigation sensor assembly (110) is curved about a longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface to thereby conform to the inner circumference of the flexible portion (118) . In this configuration, the navigation sensor assembly (110) may permit relatively more space for the larger working channel (149a) to extend along the shaft assembly (104) (eg, above the visualization and flushing assembly 108). Alternatively, the navigation sensor assembly (110) may be disposed along a generally cylindrical outer surface of the flexible portion (118) of the shaft assembly (104) and may have a generally curved configuration such that the navigation sensor assembly (110) surrounds the shaft assembly (104 ) The longitudinal axis of the flexible portion (118) is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface to thereby conform to the outer circumference of the flexible portion (118).

在任何情况下,导航传感器组件(110)可准许用于工作通道(149,149a)沿如上文所述的轴组件(104)延伸的空间,使得导航传感器组件(110)可在导管(例如,扩张导管或能量导管)通过工作通道(149,149a)朝远侧推进期间和/或当此类导管保持定位在工作通道(149,149a)内时(诸如在扩张导管的球囊充胀以扩张解剖通道期间和/或在RF能量经由能量导管的电极递送到组织期间)将位置相关信号连续地传送到处理器(52)。换句话说,柔性部分(118)的导航可与解剖通道的扩张同时进行和/或与RF能量向组织的递送同时进行,而不会彼此干扰。In any event, the navigation sensor assembly (110) may permit space for the working channels (149, 149a) to extend along the shaft assembly (104) as described above, such that the navigation sensor assembly (110) may be used in the catheter (e.g., dilation catheter or energy catheter) distally through the working channel (149, 149a) and/or while such catheter remains positioned within the working channel (149, 149a) (such as during balloon inflation of the dilation catheter to dilate the anatomical channel) and/or continuously transmits position-related signals to the processor (52) during delivery of RF energy to the tissue via the electrodes of the energy conduit). In other words, navigation of the flexible portion (118) can occur simultaneously with expansion of the anatomical passage and/or with delivery of RF energy to the tissue without interfering with each other.

如上所述,本示例的导航、可视化和冲洗组件(106)还包括设置在轴组件(104)内在导航传感器组件(110)正下方的可视化和冲洗组件(108)。可视化和冲洗组件(108)能够操作以在轴组件(104)的远侧端部(120)远侧的目标组织部位处提供可视化和冲洗。再次参考图3,该示例的可视化和冲洗组件(108)包括板构件(160)、相机(161)、一对照明元件(162,163)和一对流体导管(164,165)。相机(161)可以是其大小合适地被设置成能够适配在轴组件(104)内的相机的形式,同时仍然准许用于工作通道(149)沿轴组件(104)延伸的空间,从而准许附加器械、抽吸、流体等穿过邻近相机(161)的开口远侧端部(120)。As mentioned above, the navigation, visualization and flushing assembly (106) of this example also includes a visualization and flushing assembly (108) disposed within the shaft assembly (104) directly below the navigation sensor assembly (110). The visualization and irrigation assembly (108) is operable to provide visualization and irrigation at a target tissue site distal to the distal end (120) of the shaft assembly (104). Referring again to Figure 3, the visualization and irrigation assembly (108) of this example includes a plate member (160), a camera (161), a pair of lighting elements (162, 163), and a pair of fluid conduits (164, 165). The camera (161) may be of a form that is appropriately sized to fit within the shaft assembly (104) while still allowing space for the working channel (149) to extend along the shaft assembly (104), thereby allowing Additional instruments, suction, fluids, etc. pass through the open distal end (120) adjacent the camera (161).

照明元件(162,163)被配置并能够操作以对相机(161)的视场进行照明。照明元件(162)定位在相机(161)的一个侧向侧处,而照明元件(163)定位在相机(161)的另一侧向侧处。虽然在本示例中使用了两个照明元件(162,163),但其他型式可采用仅一个照明元件(162,163)或多于两个照明元件(162,163)。在本示例中,照明元件(162,163)包括LED。在一些其他型式中,照明元件(162,163)包括光纤部件。例如,每个照明元件(162,163)可包括与一个或多个相应光纤或光纤束光学耦合的透镜。此类光纤或光纤束可沿轴组件(104)延伸并且与集成到柄部组件(110)(或轴组件(104)从其延伸的某个其他主体)中或以其他方式提供的光源光学地耦合。Lighting elements (162, 163) are configured and operable to illuminate the field of view of the camera (161). The lighting element (162) is positioned at one lateral side of the camera (161) and the lighting element (163) is positioned at the other lateral side of the camera (161). Although two lighting elements (162,163) are used in this example, other versions may employ only one lighting element (162,163) or more than two lighting elements (162,163). In this example, the lighting elements (162, 163) include LEDs. In some other versions, the lighting elements (162, 163) include fiber optic components. For example, each lighting element (162, 163) may include a lens optically coupled to one or more corresponding optical fibers or fiber bundles. Such optical fibers or fiber bundles may extend along the shaft assembly (104) and be optically coupled to a light source integrated into the handle assembly (110) (or some other body from which the shaft assembly (104) extends) or otherwise provided. coupling.

在该示例中,导管(164,165)侧向地位于相机(161)的侧面。具体地,导管(164)相对于相机(161)定位在外侧,同时相对于照明元件(162)定位在内侧。导管(165)相对于相机(161)定位在外侧,同时相对于照明元件(163)定位在内侧。在一些型式中,两个导管(164,165)都与液体源(例如,盐水等)流体连通。在一些其他型式中,两个导管(164,165)都与抽吸源流体连通。在一些其他型式中,一个导管(164或165)与液体源流体连通,而另一导管(165或164)与抽吸源流体连通。在仍其他型式中,导管(164,165)中的一者或两者可与阀组件流体连通,其中阀组件与液体源和抽吸源耦接。在此类型式中,阀组件可用于选择性地将导管(164,165)中的一者或两者与液体源或抽吸源耦接。参考本文的教导内容,导管(164,165)中的任一者或两者可与液体源和/或抽吸源耦接的各种合适的方式对于本领域的技术人员而言将是显而易见的。在其中导管(164,165)中的至少一者与液体源连通的型式中,此类导管(164,165)可用于将此类液体递送到相机(161)的远侧端部。通过用液体冲洗相机(161)的远侧端部,导管(164,165)可用于保持相机(161)的远侧端部没有碎屑,并由此维持经由相机(161)的适当可视化。在其中导管(164,165)中的至少一者与抽吸源连通的型式中,此类导管(164,165)可用于吸走过量液体(例如,经由另一导管(164)排出的液体等)。In this example, the conduits (164, 165) are located laterally to the side of the camera (161). Specifically, the conduit (164) is positioned outside relative to the camera (161) while being positioned medially relative to the lighting element (162). The conduit (165) is positioned externally relative to the camera (161) and internally relative to the lighting element (163). In some versions, both conduits (164, 165) are in fluid communication with a source of liquid (eg, saline, etc.). In some other versions, both conduits (164, 165) are in fluid communication with the suction source. In some other versions, one conduit (164 or 165) is in fluid communication with the liquid source and the other conduit (165 or 164) is in fluid communication with the suction source. In still other versions, one or both of the conduits (164, 165) may be in fluid communication with a valve assembly coupled with a source of liquid and a source of suction. In this type of version, a valve assembly may be used to selectively couple one or both of the conduits (164, 165) with a source of liquid or suction. Various suitable ways in which either or both conduits (164, 165) may be coupled with a source of liquid and/or suction will be apparent to those skilled in the art in view of the teachings herein. In versions where at least one of the conduits (164, 165) is in communication with a source of liquid, such conduits (164, 165) may be used to deliver such liquid to the distal end of the camera (161). By flushing the distal end of the camera (161) with liquid, the catheters (164, 165) can be used to keep the distal end of the camera (161) free of debris and thereby maintain proper visualization through the camera (161). In versions where at least one of the conduits (164, 165) is in communication with a suction source, such conduits (164, 165) may be used to suck away excess liquid (eg, liquid drained via another conduit (164), etc.).

该示例的板构件(160)包括板(166)和一对横向延伸的突片(167,168)。板(166)定位在相机(161)上方,并且因此可用于屏蔽相机(161)以免被沿工作通道(149)推进的其他器械钩住和可能损坏。在所示实施方案中,导航传感器组件(110)进一步定位在板(166)上方,并且因此可同样用于屏蔽相机(161)以免被此类器械钩住。突片(167,168)被定位成与导管(164,165)的相应远侧端部的位置相对应。具体地,突片(167)恰好定位在导管(164)的远侧端部的远侧;而突片(168)恰好定位在导管(165)的远侧端部的远侧。突片(167)可进一步定位成在突片(167)的近侧面与导管(164)的远侧端部之间留有间隙(未示出),并且在突片(168)的近侧面与导管(165)的远侧端部之间可留有类似间隙。这些间隙的大小可被设置成允许液体从导管(164,165)的远侧端部逸出;并且允许经由导管(164,165)的远侧端部施加抽吸。然而,突片(167,168)的存在可有助于使经由导管(164,165)的远侧端部排出的液体朝向相机(161)的远侧端部转向。换句话说,当液体沿导管(164,165)中的任一者或两者输送并且此类液体离开此类导管(164,165)的远侧端部时,对应的突片(167,168)可使排出的液体朝向相机(161)的远侧端部转向并且由此有助于将碎屑冲洗离开相机(161)。在一些其他型式中,省略了突片(167,168)。板构件(160)仅仅是可选的。The plate member (160) of this example includes a plate (166) and a pair of laterally extending tabs (167,168). The plate (166) is positioned above the camera (161) and can therefore serve to shield the camera (161) from being snagged and possibly damaged by other instruments advancing along the working channel (149). In the embodiment shown, the navigation sensor assembly (110) is further positioned above the plate (166), and thus can also be used to shield the camera (161) from being snagged by such instruments. Tabs (167, 168) are positioned to correspond with the location of respective distal ends of catheters (164, 165). Specifically, tab (167) is positioned just distal to the distal end of catheter (164); and tab (168) is positioned just distal to the distal end of catheter (165). Tab (167) may further be positioned with a gap (not shown) between the proximal side of tab (167) and the distal end of catheter (164), and with a gap (not shown) between the proximal side of tab (168) and the distal end of catheter (164). A similar gap may be left between the distal ends of the catheter (165). These gaps may be sized to allow liquid to escape from the distal ends of the catheters (164, 165); and to allow suction to be applied via the distal ends of the catheters (164, 165). However, the presence of tabs (167, 168) may assist in redirecting liquid drained via the distal end of catheter (164, 165) toward the distal end of camera (161). In other words, as liquid is conveyed along either or both conduits (164, 165) and such liquid exits the distal end of such conduits (164, 165), the corresponding tabs (167, 168) may cause the expelled liquid to Turning towards the distal end of the camera (161) and thereby assists in flushing debris away from the camera (161). In some other versions, the tabs (167,168) are omitted. The plate member (160) is only optional.

除了前述内容之外,可视化和冲洗组件(108)的至少一部分和/或器械(100)的其他部件可根据以下美国专利申请的教导内容中的至少一些教导内容来构造和操作:2020年6月11日提交的名称为“ENT Guide with Advanceable Instrument and AdvanceableEndoscope Shaft”的美国临时专利申请63/037,640号和2021年1月27日提交的名称为“ENTInstrument with Ablation Loop and Ablation Needles”的美国临时专利申请63/142,098号。In addition to the foregoing, at least a portion of the visualization and irrigation assembly (108) and/or other components of the instrument (100) may be constructed and operated in accordance with at least some of the teachings of the following U.S. Patent Application: June 2020 The U.S. Provisional Patent Application No. 63/037,640 titled "ENT Guide with Advanceable Instrument and AdvanceableEndoscope Shaft" was filed on the 11th and the U.S. Provisional Patent Application titled "ENTInstrument with Ablation Loop and Ablation Needles" was filed on January 27, 2021. No. 63/142,098.

在一些型式中,可视化和冲洗组件(108)可被省略,使得在导航传感器组件(110)处于其横跨轴组件(104)的柔性部分(118)的内径或其他弦延伸的平坦构型的情况下(参见图3),第二工作通道(未示出)可被设置成相对于导航传感器组件(110)与工作通道(149)相对(例如,在导航传感器组件(110)下方),或者使得在导航传感器组件(110)处于其沿轴组件(104)的柔性部分(118)的柱形内表面设置的弯曲构型的情况下(参见图13),工作通道(149)的内部横截面尺寸可被扩大。In some versions, the visualization and flushing assembly (108) may be omitted such that the navigation sensor assembly (110) is in a flat configuration extending across the inner diameter or other chord of the flexible portion (118) of the shaft assembly (104). 3), a second working channel (not shown) may be positioned opposite the working channel (149) relative to the navigation sensor assembly (110) (e.g., below the navigation sensor assembly (110)), or Such that with the navigation sensor assembly (110) in its curved configuration disposed along the cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) (see Figure 13), the internal cross-section of the working channel (149) Size can be enlarged.

虽然器械(100)已被描述为用于在患者的耳、鼻或喉内扩张解剖通道和/或用于将RF能量递送到组织,但是应当了解,器械(100)可适于执行其他外科手术功能,包括例如诊断规程、电生理标测、电生理引导的导管引导外科手术和/或心脏消融规程。Although instrument (100) has been described for use in dilating anatomical passages within a patient's ear, nose, or throat and/or for delivering RF energy to tissue, it should be understood that instrument (100) may be adapted to perform other surgical procedures. Functionality, including, for example, diagnostic procedures, electrophysiological mapping, electrophysiologically guided catheter-guided surgery, and/or cardiac ablation procedures.

B.带有集成到导航传感器组件上的相机电路和温度传感器的示例性导航、可视化B. Exemplary Navigation,Visualization with Camera Circuitry and Temperature Sensor Integrated on the Navigation Sensor Assembly 和冲洗组件and flush components

在一些情况下,可能期望提供导航、可视化和冲洗组件,该导航、可视化和冲洗组件具有集成到其导航传感器组件上的用于可视化和冲洗组件(108)的相机(161)的电路,诸如用于消除沿轴组件(104)将电线或电缆布线到相机(161)的需要。与导航、可视化和冲洗组件(106)相比,将用于相机(161)的电路集成到已经用于其他目的(例如,用于导航传感器组件电路等)的柔性电路中可增加灵活性和/或减小尺寸。因此,工作通道(149)的内部横截面尺寸可被扩大,并且/或者轴组件(104)的外部横截面尺寸可被减小。另外或另选地,可能期望监测与此类导航传感器组件相关联的温度,诸如为了提高经由导航传感器组件确定的位置坐标的准确性,该位置坐标原本可能受温度变化的不利影响。图14至图23示出了具有此类功能的导航、可视化和冲洗组件(206)的示例,并且该导航、可视化和冲洗组件可取代导航、可视化和冲洗组件(106)结合到器械(100)中。导航、可视化和冲洗组件(206)具有导航传感器组件(210)和设置在导航传感器组件(210)正下方的可视化和冲洗组件(108),并且可类似于导航、可视化和冲洗组件(106),除非另外描述。In some cases, it may be desirable to provide a navigation, visualization, and irrigation assembly with circuitry for the camera (161) of the visualization and irrigation assembly (108) integrated onto its navigation sensor assembly, such as with This eliminates the need to route wires or cables along the axis assembly (104) to the camera (161). Integrating the circuitry for the camera (161) into a flex circuit already used for other purposes (e.g., for navigation sensor assembly circuitry, etc.) increases flexibility and/or compared to the navigation, visualization, and flushing assembly (106) or reduce size. Accordingly, the internal cross-sectional dimensions of the working channel (149) may be enlarged, and/or the external cross-sectional dimensions of the shaft assembly (104) may be reduced. Additionally or alternatively, it may be desirable to monitor the temperature associated with such navigation sensor assemblies, such as to improve the accuracy of position coordinates determined via the navigation sensor assembly, which position coordinates may otherwise be adversely affected by temperature changes. Figures 14-23 illustrate examples of navigation, visualization and irrigation components (206) having such functionality and which may be incorporated into the instrument (100) in place of the navigation, visualization and irrigation component (106) middle. The navigation, visualization and flushing component (206) has a navigation sensor component (210) and a visualization and flushing component (108) disposed directly below the navigation sensor component (210) and may be similar to the navigation, visualization and flushing component (106), Unless otherwise described.

现在参考图15至图22,该示例的导航传感器组件(210)以柔性印刷电路板(PCB)的形式提供,并且包括细长的、大致矩形的柔性电路基板(226),该柔性电路基板上形成(例如,印刷和/或嵌入)有多个热电偶(227a,227b,227c,227d)、相机迹线(228a,228b,228c,228d)、对应的相机迹线引线(229a,229b,229c,229d,229e,229f,229g,229h)、传感器迹线(230,232,234,236)、对应的传感器迹线引线(238a,238,238c,238d)以及接地引线(239a,239b)。如图所示,基板(226)在近侧端部与远侧端部(240,241)之间纵向延伸,在第一侧与第二侧(242,243)之间侧向延伸,并且在顶部表面与底部表面(244,245)之间竖直延伸。本示例的基板(226)包括在顶部表面与底部表面(244,245)之间延伸的通孔(246)。通孔(246)可被构造成接纳销(未示出)或其他合适的紧固件,以将导航传感器组件(210)固定到轴组件(104)的柔性部分(118)和/或器械(100)的任何其他部件,诸如可视化和冲洗组件(108)。在所示型式中,基板(226)还包括在近侧端部(240)与第一侧(242)之间延伸的近侧斜面(248)。近侧斜面(248)可被构造成有助于将近侧端部(240)定位在相对于轴组件(104)的柔性部分(118)和/或相对于器械(100)的任何其他部件(诸如可视化和冲洗组件(108))的期望位置处。Referring now to Figures 15-22, the example navigation sensor assembly (210) is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (226) on which Formed (e.g., printed and/or embedded) with a plurality of thermocouples (227a, 227b, 227c, 227d), camera traces (228a, 228b, 228c, 228d), corresponding camera trace leads (229a, 229b, 229c , 229d, 229e, 229f, 229g, 229h), sensor traces (230, 232, 234, 236), corresponding sensor trace leads (238a, 238, 238c, 238d) and ground leads (239a, 239b). As shown, the base plate (226) extends longitudinally between the proximal and distal ends (240, 241), laterally between the first and second sides (242, 243), and between the top surface and the bottom surface. Extend vertically between surfaces (244,245). The substrate (226) of this example includes a via (246) extending between the top and bottom surfaces (244, 245). The through hole (246) may be configured to receive a pin (not shown) or other suitable fastener to secure the navigation sensor assembly (210) to the flexible portion (118) of the shaft assembly (104) and/or the instrument ( Any other components of 100), such as visualization and flushing components (108). In the version shown, the base plate (226) also includes a proximal ramp (248) extending between the proximal end (240) and the first side (242). The proximal ramp (248) may be configured to facilitate positioning the proximal end (240) relative to the flexible portion (118) of the shaft assembly (104) and/or relative to any other components of the instrument (100) such as Visualize and rinse component (108)) at the desired location.

基板(226)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或液晶聚合物(LCP)。例如,在期望维持基板(226)的相对平坦构型的情况下,基板(226)可由聚酰亚胺形成,因为由聚酰亚胺形成的此类基板(226)可朝向自然平坦构型弹性偏置。另选地,在期望基板(226)的更复杂几何构型和/或增加的柔性的情况下,基板(226)可由LCP形成,因为由LCP形成的基板(226)可被热成形以适应此类复杂几何形状和/或提供增加的柔性,如下文所述。在任何情况下,传感器迹线(230,232,234,236)、传感器引线(238a,238b,238c,238d)、相机迹线(228a,228b,228c,228d)和相机引线(229a,229b,229c,229d,229e,229f,229g,229h)均可由诸如铜的导电金属材料形成。导航传感器组件(210)的大小合适地被设置成适配在轴组件(104)内,同时仍然准许用于工作通道(149)沿轴组件(104)延伸(例如,在导航传感器组件(210)上方)的空间,从而准许附加器械(例如,扩张导管和/或能量导管)、抽吸、流体等穿过邻近导航传感器组件(210)的开口远侧端部(120)。就这一点而言,至少与传统的线圈传感器相比,导航传感器组件(210)可具有相对低轮廓。在一些型式中,导航传感器组件(210)可具有大约50微米的厚度。Substrate (226) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (226), the substrate (226) may be formed from polyimide because such a substrate (226) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (226) are desired, substrate (226) may be formed from LCP, as substrate (226) formed from LCP may be thermoformed to accommodate this. class complex geometries and/or provide increased flexibility, as discussed below. In any case, sensor traces (230, 232, 234, 236), sensor leads (238a, 238b, 238c, 238d), camera traces (228a, 228b, 228c, 228d) and camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) may each be formed of a conductive metal material such as copper. The navigation sensor assembly (210) is appropriately sized to fit within the shaft assembly (104) while still permitting for the working channel (149) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (210) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (210). In this regard, the navigation sensor assembly (210) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (210) may have a thickness of approximately 50 microns.

如图15和图16所示,传感器迹线(230,232,234,236)包括各自形成在基板(226)的顶部表面(244)上的近侧顶部传感器迹线(230)和远侧顶部传感器迹线(232),以及各自形成在基板(226)的底部表面(245)上的与对应的顶部传感器迹线(230,232)相对和/或平行的近侧底部传感器迹线(234)和远侧底部传感器迹线(236)。传感器引线(238a,238b,238c,238d)包括各自形成在基板(226)的顶部表面(244)上的第一外部传感器引线和第二外部传感器引线(238a,238b)以及第一内部传感器引线和第二内部传感器引线(238c,238d)。相机迹线(228a,228b,228c,228d)包括各自形成在基板(226)的顶部表面(244)上的第一外部相机迹线和第二外部相机迹线(228a,228b)以及第一内部相机迹线和第二内部相机迹线(228c,228d)。相机引线(229a,229b,229c,229d,229e,229f,229g,229h)包括各自形成在基板(226)的顶部表面(244)上的第一近侧外部相机引线和第二近侧外部相机引线(229a,229b)、第一近侧内部相机引线和第二近侧内部相机引线(229c,229d)、第一远侧外部相机引线和第二远侧外部相机引线(229e,229f)以及第一远侧内部相机引线和第二远侧内部相机引线(229g,229h)。接地引线(239a,239b)包括各自形成在基板(226)的顶部表面(244)上的第一近侧接地引线和第二近侧接地引线(239a,239b)。热电偶(227a,227b,227c,227d)包括各自形成在基板(226)的顶部表面(244)上的第一近侧热电偶和第二近侧热电偶(227a,227b)以及第一远侧热电偶和第二远侧热电偶(227c,227d)。顶部传感器迹线(230,232)、传感器引线(238a,238b,238c,238d)、相机迹线(228a,228b,228c,228d)、相机引线(229a,229b,229c,229d,229e,229f,229g,229h)、接地引线(239a,239b)和热电偶(227a,227b,227c,227d)共同限定导航传感器组件(210)的顶部柔性电路层,而底部传感器迹线(234,236)共同限定导航传感器组件(210)的底部柔性电路层。As shown in Figures 15 and 16, sensor traces (230, 232, 234, 236) include a proximal top sensor trace (230) and a distal top sensor trace (232) each formed on the top surface (244) of the substrate (226) , as well as proximal bottom sensor traces (234) and distal bottom sensor traces ( 236). The sensor leads (238a, 238b, 238c, 238d) include first and second outer sensor leads (238a, 238b) each formed on a top surface (244) of the substrate (226) and a first inner sensor lead and Second internal sensor leads (238c, 238d). Camera traces (228a, 228b, 228c, 228d) include first and second external camera traces (228a, 228b) each formed on a top surface (244) of the substrate (226) and a first internal Camera trace and second internal camera trace (228c, 228d). Camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) include first and second proximal external camera leads each formed on a top surface (244) of the substrate (226) (229a, 229b), first and second near-side internal camera leads (229c, 229d), first and second far-side external camera leads (229e, 229f) and first A far-side internal camera lead and a second far-side internal camera lead (229g, 229h). Ground leads (239a, 239b) include first and second proximal ground leads (239a, 239b) each formed on the top surface (244) of the substrate (226). Thermocouples (227a, 227b, 227c, 227d) include first and second proximal thermocouples (227a, 227b) each formed on the top surface (244) of the substrate (226) and a first distal Thermocouple and second distal thermocouple (227c, 227d). Top sensor traces (230,232), sensor leads (238a, 238b, 238c, 238d), camera traces (228a, 228b, 228c, 228d), camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h), ground leads (239a, 239b), and thermocouples (227a, 227b, 227c, 227d) collectively define the top flex circuit layer of the navigation sensor assembly (210), while the bottom sensor traces (234, 236) collectively define the navigation sensor assembly ( 210) bottom flexible circuit layer.

现在参考图17至图22,传感器迹线(230,232,234,236)各自包括相应的第一纵向部分(230a,232a,234a,236a)、同心环部分(230b,232b,234b,236b)和第二纵向部分(230c,232c,234c,236c)。如图所示,远侧迹线(232,236)的同心环部分(232b,236b)相对于相应近侧迹线(230,234)的同心环部分(230b,234b)定位在远侧。此外,同心环部分(230b,232b,234b,236b)各自侧向地位于相机迹线(228a,228b,228c,228d)的侧面。Referring now to Figures 17-22, sensor traces (230, 232, 234, 236) each include respective first longitudinal portions (230a, 232a, 234a, 236a), concentric ring portions (230b, 232b, 234b, 236b) and second longitudinal portions ( 230c,232c,234c,236c). As shown, the concentric ring portions (232b, 236b) of the distal traces (232, 236) are positioned distally relative to the concentric ring portions (230b, 234b) of the corresponding proximal traces (230, 234). Additionally, concentric ring portions (230b, 232b, 234b, 236b) are each located laterally to the side of the camera traces (228a, 228b, 228c, 228d).

第一外部传感器引线(238a)电耦接到远侧顶部迹线(232)的第一纵向部分(232a)的近侧端部。远侧顶部迹线(232)的第一纵向部分(232a)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到远侧底部迹线(236)的第一纵向部分(236a)的远侧端部。远侧底部迹线(236)的第一纵向部分(236a)从其远侧端部朝向与第一外部传感器引线(238a)相对的底部表面(245)上的位置朝近侧延伸,并且在其近侧端部处电耦接到远侧底部迹线(236)的第二纵向部分(236c)的近侧端部。远侧底部迹线(236)的第二纵向部分(236c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到远侧底部迹线(236)的同心环部分(236b)的径向外端。远侧底部迹线(236)的同心环部分(236b)从其径向外端径向向内螺旋,并且在其径向内端处电耦接到远侧顶部迹线(232)的同心环部分(232b)的径向内端。远侧顶部迹线(232)的同心环部分(232b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到远侧顶部迹线(232)的第二纵向部分(232c)的远侧端部。远侧顶部迹线(232)的第二纵向部分(232c)从其远侧端部朝近侧延伸到第一内部传感器引线(238c),并且在其近侧端部处电耦接到该第一内部传感器引线。The first outer sensor lead (238a) is electrically coupled to the proximal end of the first longitudinal portion (232a) of the distal top trace (232). A first longitudinal portion (232a) of the distal top trace (232) extends distally from a proximal end thereof and is electrically coupled at its distal end to a first portion of the distal bottom trace (236). The distal end of the longitudinal portion (236a). A first longitudinal portion (236a) of the distal bottom trace (236) extends proximally from its distal end toward a location on the bottom surface (245) opposite the first outer sensor lead (238a) and is The proximal end is electrically coupled to the proximal end of the second longitudinal portion (236c) of the distal bottom trace (236). A second longitudinal portion (236c) of the distal bottom trace (236) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of the distal bottom trace (236) Radially outer end of portion (236b). The concentric ring portion (236b) of the distal bottom trace (236) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the distal top trace (232) Radially inner end of portion (232b). The concentric ring portion (232b) of the distal top trace (232) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (232b) of the distal top trace (232). The distal end of the longitudinal portion (232c). A second longitudinal portion (232c) of the distal top trace (232) extends proximally from its distal end to the first inner sensor lead (238c) and is electrically coupled at its proximal end to the first inner sensor lead (238c). An internal sensor lead.

第二外部传感器引线(238b)电耦接到近侧顶部迹线(230)的第一纵向部分(230a)的近侧端部。近侧顶部迹线(230)的第一纵向部分(230a)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到近侧底部迹线(234)的第一纵向部分(234a)的远侧端部。近侧底部迹线(234)的第一纵向部分(234a)从其远侧端部朝向与第二外部传感器引线(238b)相对的底部表面(245)上的位置朝近侧延伸,并且在其近侧端部处电耦接到近侧底部迹线(234)的第二纵向部分(234c)的近侧端部。近侧底部迹线(234)的第二纵向部分(234c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到近侧底部迹线(234)的同心环部分(234b)的径向外端。近侧底部迹线(234)的同心环部分(234b)从其径向外端径向向内螺旋,并且在其径向内端处电耦接到近侧顶部迹线(230)的同心环部分(230b)的径向内端。近侧顶部迹线(230)的同心环部分(230b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到近侧顶部迹线(230)的第二纵向部分(230c)的远侧端部。近侧顶部迹线(230)的第二纵向部分(230c)从其远侧端部朝近侧延伸到第二内部传感器引线(238d),并且在其近侧端部处电耦接到该第二内部传感器引线。A second outer sensor lead (238b) is electrically coupled to the proximal end of the first longitudinal portion (230a) of the proximal top trace (230). A first longitudinal portion (230a) of the proximal top trace (230) extends distally from a proximal end thereof and is electrically coupled at its distal end to a first portion of the proximal bottom trace (234). The distal end of the longitudinal portion (234a). A first longitudinal portion (234a) of the proximal bottom trace (234) extends proximally from its distal end toward a location on the bottom surface (245) opposite the second outer sensor lead (238b) and is The proximal end is electrically coupled to the proximal end of the second longitudinal portion (234c) of the proximal bottom trace (234). A second longitudinal portion (234c) of the proximal bottom trace (234) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (234) Radially outer end of portion (234b). The concentric ring portion (234b) of the proximal bottom trace (234) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the proximal top trace (230) Radially inner end of portion (230b). The concentric ring portion (230b) of the proximal top trace (230) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (230b) of the proximal top trace (230). The distal end of the longitudinal portion (230c). A second longitudinal portion (230c) of the proximal top trace (230) extends proximally from its distal end to a second inner sensor lead (238d) and is electrically coupled at its proximal end to the second inner sensor lead (238d). Two internal sensor leads.

以与上文所述的方式类似的方式,每个同心环部分(230,232,234,236)限定相应的导航传感器(250,252,254,256),该导航传感器能够操作以生成指示相应的导航传感器(250,252,254,256)的位置并且由此指示器械(100)的至少一部分(例如,轴组件(104)的柔性部分(118))在三维空间中的位置的信号。由此类位置相关信号生成的位置数据可由处理器(52)处理以用于向操作者提供视觉指示,以实时地向操作者显示器械(100)的轴组件(104)在患者(P)体内所位于的位置。此类视觉指示可被提供为在患者解剖结构的一个或多个术前获得的图像(例如,CT扫描)上的叠加。In a manner similar to that described above, each concentric ring portion (230, 232, 234, 236) defines a respective navigation sensor (250, 252, 254, 256) operable to generate an indication of the position of the respective navigation sensor (250, 252, 254, 256) and thereby indicate A signal of the position of at least a portion of the instrument (100) (eg, the flexible portion (118) of the shaft assembly (104)) in three-dimensional space. Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator, in real time, that the shaft assembly (104) of the instrument (100) is within the patient (P) location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

第一近侧外部相机引线(229a)电耦接到第一外部相机迹线(228a)的近侧端部,该第一外部相机迹线从其近侧端部朝远侧延伸到第一远侧外部相机引线(229e)并且在其远侧端部处电耦接到该第一远侧外部相机引线。第二近侧外部相机引线(229b)电耦接到第二外部相机迹线(228b)的近侧端部,该第二外部相机迹线从其近侧端部朝远侧延伸到第二远侧外部相机引线(229f)并且在其远侧端部处电耦接到该第二远侧外部相机引线。第一近侧内部相机引线(229c)电耦接到第一内部相机迹线(228c)的近侧端部,该第一内部相机迹线从其近侧端部朝远侧延伸到第一远侧内部相机引线(229g)并且在其远侧端部成电耦接到该第一远侧内部相机引线。第二近侧内部相机引线(229d)电耦接到第二内部相机迹线(228d)的近侧端部,该第二内部相机迹线从其近侧端部朝远侧延伸到第二远侧内部相机引线(229h)并且在其远侧端部处电耦接到该第二远侧内部相机引线。A first proximal external camera lead (229a) is electrically coupled to a proximal end of a first external camera trace (228a) that extends distally from its proximal end to a first distal side external camera lead (229e) and is electrically coupled at its distal end to the first distal external camera lead. A second proximal external camera lead (229b) is electrically coupled to a proximal end of a second external camera trace (228b) that extends distally from its proximal end to a second distal side external camera lead (229f) and is electrically coupled at its distal end to the second distal external camera lead. A first proximal internal camera lead (229c) is electrically coupled to a proximal end of a first internal camera trace (228c) that extends distally from its proximal end to a first distal A side inner camera lead (229g) is electrically coupled at its distal end to the first distal inner camera lead. A second proximal internal camera lead (229d) is electrically coupled to a proximal end of a second internal camera trace (228d) that extends distally from its proximal end to a second distal side inner camera lead (229h) and is electrically coupled at its distal end to the second distal inner camera lead.

因此,电流信号和/或图像信号通常可经由第一外部相机迹线(228a)在第一近侧外部相机引线与第一远侧外部相机引线(229a,229e)之间流动,经由第二外部相机迹线(228b)在第二近侧外部相机引线与第二远侧外部相机引线(229b,229f)之间流动,经由第一内部相机迹线(228c)在第一近侧内部相机引线与第一远侧内部相机引线(229e,229g)之间流动,和/或经由第二内部相机迹线(228d)在第二近侧内部相机引线与第二远侧内部相机引线(229d,229h)之间流动。这样,相机迹线(228a,228b,228c,228d)和相机引线(229a,229b,229c,229d,229e,229f,229g,229h)可用于将可视化和冲洗组件(108)的相机(161)操作地耦接到处理器(52),以将图像信号从相机(161)传输到处理器(52)(这可由此经由显示屏(56)实时地提供视频),并且/或者可将相机(161)操作地耦接到功率源(未示出),以向相机(161)供应电力。Accordingly, current signals and/or image signals may generally flow between the first proximal external camera lead and the first distal external camera lead (229a, 229e) via the first external camera trace (228a), via the second external camera trace (228a). The camera trace (228b) flows between the second nearside outer camera lead and the second farside outer camera lead (229b, 229f) via the first inner camera trace (228c) between the first nearside inner camera lead and Flow between the first far-side internal camera leads (229e, 229g) and/or between the second near-side internal camera lead and the second far-side internal camera lead (229d, 229h) via the second internal camera trace (228d) flow between. In this way, camera traces (228a, 228b, 228c, 228d) and camera leads (229a, 229b, 229c, 229d, 229e, 229f, 229g, 229h) can be used to visualize and flush the camera (161) operation of the assembly (108) is coupled to the processor (52) to transmit image signals from the camera (161) to the processor (52) (which may thereby provide video in real time via the display screen (56)), and/or the camera (161 ) is operatively coupled to a power source (not shown) to supply power to the camera (161).

在一些型式中,限定在基板(226)的近侧端部和远侧端部(240,241)之间的导航传感器组件(210)的长度可足够大以将远侧导航传感器(252,256)定位在轴组件(104)的远侧端部(120)处或附近以便于远侧端部(120)的导航,同时还将传感器引线(238a,238b,238c,238d)定位在足够近侧的位置处,在该位置处传感器引线(238a,238b,238c,238d)可直接电耦接到耦接单元(例如,无需插入电线或电缆)。同样,导航传感器组件(210)的长度可足够大以将远侧相机引线(229e,229f,229g,229h)定位在足够远侧的位置处,在该位置处,远侧相机引线(229e,229f,229g,229h)可直接电耦接到相机(161)(例如,无需插入电线或电缆),同时还将近侧相机引线(229a,229b,229c,229d)定位在足够近侧的位置处,在该位置处,近侧相机引线(229a,229b,229c,229d)可直接电耦接到耦接单元(例如,无需插入电线或电缆)。就这一点而言,导航传感器组件(210)的长度可基本上等于或大于轴组件(104)的长度,使得传感器引线(238a,238b,238c,238d)和/或近侧相机引线(229a,229b,229c,229d)可定位在柄部组件(110)的主体(112)内或甚至相对于该柄部组件的该主体定位在近侧。例如,导航传感器组件(210)可具有大约数米的长度。这样,导航传感器组件(210)既可生成位置相关信号又可将位置相关信号传输到耦接单元,而不需要在该耦接单元之间布线电线或电缆;并且还可既向相机(161)供应电力又将图像信号从该相机传输到耦接单元,而不需要在该耦接单元之间布线电线或电缆。In some versions, the length of the navigation sensor assembly (210) defined between the proximal and distal ends (240, 241) of the base plate (226) may be large enough to position the distal navigation sensors (252, 256) on-axis. at or near the distal end (120) of the assembly (104) to facilitate navigation of the distal end (120) while also positioning the sensor leads (238a, 238b, 238c, 238d) at a sufficiently proximal location, At this location the sensor leads (238a, 238b, 238c, 238d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). Likewise, the length of the navigation sensor assembly (210) may be large enough to position the far-side camera leads (229e, 229f, 229g, 229h) at a sufficiently distal location where the far-side camera leads (229e, 229f , 229g, 229h) may be electrically coupled directly to the camera (161) (e.g., without the need to insert wires or cables) while also positioning the proximal camera leads (229a, 229b, 229c, 229d) proximally enough to In this position, the near-side camera leads (229a, 229b, 229c, 229d) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (210) may be substantially equal to or greater than the length of the shaft assembly (104) such that the sensor leads (238a, 238b, 238c, 238d) and/or the proximal camera leads (229a, 229b, 229c, 229d) may be positioned within the body (112) of the handle assembly (110) or even proximally relative to the body of the handle assembly. For example, navigation sensor assembly (210) may be on the order of several meters in length. In this way, the navigation sensor assembly (210) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units; and can also both generate and transmit position-related signals to the camera (161) The power supply in turn transmits image signals from the camera to the coupling unit without the need to run wires or cables between the coupling units.

如上所述,本示例的导航传感器组件(210)还包括定位在基板(226)的顶部表面(244)上的热电偶(227a,227b,227c,227d)形式的多个温度传感器。再次参考图15,近侧热电偶(227a,227b)各自定位成相对靠近近侧顶部导航传感器(250),并且远侧热电偶(227c,227d)各自定位成相对靠近远侧顶部导航传感器(252)。因此,近侧热电偶(227a,227b)能够操作以检测基板(226)和/或位于近侧顶部导航传感器(252)处或附近的周围环境的温度,并且远侧热电偶(227c,227d)能够操作以检测基板(226)和/或位于远侧顶部导航传感器(250)处或附近的周围环境的温度。每个热电偶(227a,227b,227c,227d)能够操作以生成指示相应所检测温度并且由此指示相应导航传感器(250,252)的温度的信号。由此类温度相关信号生成的温度数据可由处理器(52)处理以提高由处理器(52)根据导航传感器(250,252,254,256)的位置相关信号计算的位置坐标的准确性。As mentioned above, the navigation sensor assembly (210) of this example also includes a plurality of temperature sensors in the form of thermocouples (227a, 227b, 227c, 227d) positioned on the top surface (244) of the substrate (226). Referring again to Figure 15, the proximal thermocouples (227a, 227b) are each positioned relatively proximate the proximal top navigation sensor (250), and the distal thermocouples (227c, 227d) are each positioned relatively proximate the distal top navigation sensor (252). ). Accordingly, the proximal thermocouples (227a, 227b) are operable to sense the temperature of the substrate (226) and/or the surrounding environment at or near the proximal top navigation sensor (252), and the distal thermocouples (227c, 227d) Operable to sense the temperature of the substrate (226) and/or the surrounding environment at or near the distal top navigation sensor (250). Each thermocouple (227a, 227b, 227c, 227d) is operable to generate a signal indicative of a respective detected temperature and thereby the temperature of a respective navigation sensor (250, 252). Temperature data generated from such temperature-related signals may be processed by the processor (52) to improve the accuracy of position coordinates calculated by the processor (52) based on the position-related signals of the navigation sensors (250, 252, 254, 256).

就这一点而言,应当了解,导航传感器(250,252,254,256)的温度的变化(例如,增加)可导致相应同心环部分(230b,232b,234b,236b)的电阻的相应变化,这又可导致由交变电磁场在该同心环部分中生成的感应电流的相应变化,使得由处理器(52)根据所得位置相关信号计算的位置坐标的准确性可能受到不利影响。此类温度变化可与其对应的电阻变化直接相关联,使得处理器(52)可基于温度数据来调整位置坐标的计算以校正由温度变化引起的任何电阻变化。In this regard, it should be understood that changes (eg, increases) in the temperature of the navigation sensors (250, 252, 254, 256) can lead to corresponding changes in the resistance of the corresponding concentric ring portions (230b, 232b, 234b, 236b), which in turn can lead to The accuracy of the position coordinates calculated by the processor (52) based on the resulting position-related signals may be adversely affected by corresponding changes in the induced current generated by the varying electromagnetic field in the concentric ring portion. Such temperature changes can be directly correlated with their corresponding resistance changes, such that the processor (52) can adjust the calculation of position coordinates based on the temperature data to correct for any resistance changes caused by the temperature changes.

现在参考图23,提供了一种用于基于由处理器(52)从导航传感器(250,252,254,256)接收的位置相关信号并且进一步基于由处理器(52)从热电偶(227a,227b,227c,227d)接收的温度相关信号来确定位置坐标的方法(301)。方法(301)开始于步骤(303),在该步骤处,温度相关信号指示导航传感器(250,252,254,256)的第一温度等于环境温度,使得导航传感器(250,252,254,256)中不存在要考虑的温度变化引起的电阻变化,并且处理器(52)基于从导航传感器(250,252,254,256)接收到的位置相关信号来计算准确的位置坐标。Referring now to Figure 23, a method is provided for position-related signals received by a processor (52) from navigation sensors (250, 252, 254, 256) and further based on position-related signals received by a processor (52) from thermocouples (227a, 227b, 227c, 227d). Method (301) of determining position coordinates based on received temperature-related signals. The method (301) begins with step (303), where the temperature-related signal indicates that the first temperature of the navigation sensor (250, 252, 254, 256) is equal to the ambient temperature, such that there is no temperature change-induced resistance in the navigation sensor (250, 252, 254, 256) to be considered changes, and the processor (52) calculates accurate location coordinates based on location-related signals received from the navigation sensors (250, 252, 254, 256).

方法(301)从步骤(303)前进至步骤(305),在该步骤处,温度相关信号指示导航传感器(250,252,254,256)的第二温度大于环境温度,使得可能需要考虑导航传感器(250,252,254,256)中的温度变化引起的电阻变化;并且处理器(52)基于从导航传感器(250,252,254,256)接收到的位置相关信号来计算电阻变化移位的位置坐标。例如,此类温度升高可由在工作通道(149)内操作动力器械(例如,能量导管、手术剃刀等)引起。在任何情况下,方法(301)从步骤(305)前进至步骤(307),在该步骤处,处理器(52)计算从第一温度到第二温度的温度变化(例如,第一温度与第二温度之间的差)。The method (301) proceeds from step (303) to step (305) where the temperature-related signal indicates that the second temperature of the navigation sensor (250,252,254,256) is greater than the ambient temperature such that the temperature in the navigation sensor (250,252,254,256) may need to be considered The resistance change caused by the change; and the processor (52) calculates the position coordinates of the resistance change shift based on the position-related signals received from the navigation sensor (250, 252, 254, 256). For example, such temperature increases may be caused by operating powered instruments (eg, energy catheters, surgical razors, etc.) within the working channel (149). In any case, the method (301) proceeds from step (305) to step (307) where the processor (52) calculates the temperature change from the first temperature to the second temperature (eg, the first temperature and the difference between the second temperatures).

方法(301)从步骤(307)前进至步骤(309),在该步骤处,处理器(52)经由所存储的导航移位模型基于温度变化来确定校正因子,该导航移位模型将温度变化与相应的校正因子相关联,以考虑由此类温度变化引起的电阻变化。方法(301)从步骤(309)前进至步骤(311),在该步骤处,处理器(52)将校正因子应用于电阻变化移位的位置坐标,以由此确定考虑由第一温度与第二温度之间的温度变化引起的电阻变化的准确位置坐标。The method (301) proceeds from step (307) to step (309) where the processor (52) determines a correction factor based on the temperature change via a stored navigation displacement model that converts the temperature change into Corresponding correction factors are associated to account for changes in resistance caused by such temperature changes. The method (301) proceeds from step (309) to step (311), where the processor (52) applies a correction factor to the position coordinates shifted by the resistance change to thereby determine the difference between the first temperature and the first temperature. The temperature change between the two temperatures causes the exact position coordinates of the resistance change.

虽然示出了热电偶(227a,227b,227c,227d)形式的温度传感器,但是可使用任何其他合适类型的温度传感器,诸如热敏电阻器。在一些型式中,可省略热电偶(227a,227b,227c,227d),诸如在温度变化不是典型的情况下(例如,当在工作通道(149)内操作无动力器械时)。在其他型式中,导航传感器(250,252,254,256)的温度变化可通过检测相应同心环部分(230b,232b,234b,236b)的阻抗变化来确定。例如,应当了解,铜具有相对大的热膨胀系数,使得阻抗变化可与其相应的温度变化直接相关。因此,处理器(52)可基于阻抗数据来调整位置坐标的计算,从而以与上文所述的方式类似的方式校正由温度变化引起的任何电阻变化。Although temperature sensors in the form of thermocouples (227a, 227b, 227c, 227d) are shown, any other suitable type of temperature sensor may be used, such as a thermistor. In some versions, thermocouples (227a, 227b, 227c, 227d) may be omitted, such as where temperature changes are not typical (eg, when operating unpowered instruments within working channel (149)). In other versions, temperature changes of the navigation sensors (250, 252, 254, 256) may be determined by detecting changes in impedance of corresponding concentric ring portions (230b, 232b, 234b, 236b). For example, it should be understood that copper has a relatively large coefficient of thermal expansion such that impedance changes can be directly related to its corresponding temperature changes. Accordingly, the processor (52) may adjust the calculation of the position coordinates based on the impedance data to correct for any changes in resistance caused by temperature changes in a manner similar to that described above.

C.带有蛇形柔性导航传感器组件的示例性器械C. Exemplary Instrument with Snake-Shaped Flexible Navigation Sensor Assembly

图24至图26C示出了可用于扩张解剖通道和/或将RF能量递送到组织的器械(400)的另一示例。例如,器械(400)可用于鼻旁窦口的扩张(例如,以治疗鼻窦炎)、喉扩张、咽鼓管扩张、耳、鼻或喉内其他通道的扩张等。另外或另选地,器械(400)可用于消融神经(例如,后鼻神经);消融鼻甲;或消融、电穿孔(例如,以促进治疗剂的吸收等),或将电阻加热施加到患者头部中的任何其他种类的解剖结构。该示例的器械(400)包括柄部组件(102)、轴组件(104)和导航传感器组件(410),该导航传感器组件可类似于导航传感器组件(110),除非另外描述。Figures 24-26C illustrate another example of an instrument (400) that can be used to dilate anatomical channels and/or deliver RF energy to tissue. For example, the device (400) may be used for dilation of paranasal sinus ostia (eg, to treat sinusitis), laryngeal dilation, Eustachian tube dilation, ear, nose, or other passages within the throat, and the like. Additionally or alternatively, instrument (400) may be used to ablate nerves (e.g., posterior nasal nerve); ablate turbinates; or ablate, electroporate (e.g., to facilitate absorption of therapeutic agents, etc.), or apply resistive heating to the patient's head any other kind of anatomical structure in the body. The example instrument (400) includes a handle assembly (102), a shaft assembly (104), and a navigation sensor assembly (410), which may be similar to the navigation sensor assembly (110) unless otherwise described.

器械(400)可与充胀流体源(未示出)耦接,该充胀流体源能够操作以选择性地将充胀流体供应到器械(400)的扩张导管(未示出)的球囊,用于使球囊充胀,从而扩张解剖通道。另外或另选地,器械(400)可与RF发生器(101)耦接,该RF发生器能够操作以生成用于经由位于轴组件(104)的远侧端部处的电极(121,122)递送到组织的RF电外科能量,从而对组织进行消融、电穿孔或施加电阻加热。从图25A到图25B的转变示出了轴组件(104)的柔性部分(118)从直线构型(图25A)弯曲到弯曲构型(图25B),并且由此使远侧端部(120)侧向偏转远离刚性部分(116)的纵向轴线。Instrument (400) may be coupled with a source of inflation fluid (not shown) operable to selectively supply inflation fluid to a balloon of a dilation catheter (not shown) of instrument (400) , used to inflate the balloon to expand the anatomical passage. Additionally or alternatively, instrument (400) may be coupled with an RF generator (101) operable to generate electricity for delivery via electrodes (121, 122) located at the distal end of shaft assembly (104). RF electrosurgical energy is delivered to tissue to ablate, electroporate, or apply resistive heating to the tissue. The transition from Figure 25A to Figure 25B shows the flexible portion (118) of the shaft assembly (104) bending from a straight configuration (Figure 25A) to a curved configuration (Figure 25B), and thereby causing the distal end (120 ) deflects laterally away from the longitudinal axis of the rigid portion (116).

如图25A和图25B最佳所示,导航传感器组件(410)设置在轴组件(104)内并且能够操作以向轴组件(104)提供导航能力。更具体地,导航传感器组件(410)以至少一个大致弯曲构型沿轴组件(104)的柔性部分(118)的大致柱形内表面设置,在该至少一个大致弯曲构型中,导航传感器组件(410)围绕轴组件(104)的柔性部分(118)的纵向轴线以对应于柔性部分(118)的柱形内表面的曲率半径的曲率半径弯曲,以由此适形于柔性部分(118)的内圆周。As best shown in Figures 25A and 25B, a navigation sensor assembly (410) is disposed within the shaft assembly (104) and is operable to provide navigation capabilities to the shaft assembly (104). More specifically, the navigation sensor assembly (410) is disposed along a generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104) in at least one generally curved configuration in which the navigation sensor assembly (410) Curve about the longitudinal axis of the flexible portion (118) of the shaft assembly (104) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface of the flexible portion (118) to thereby conform to the flexible portion (118) the inner circumference.

现在参考图26A至26C,该示例的导航传感器组件(410)以柔性印刷电路板(PCB)的形式提供,并且包括蛇形柔性电路基板(426),该蛇形柔性电路基板上定位有一对侧向相邻的远侧导航传感器(452,453)和对应的引线(未示出)。如图所示,基板(426)在近侧端部与远侧端部(440,441)之间纵向延伸,在第一侧与第二侧(442,443)之间侧向延伸,并且在顶部表面与底部表面(444,445)之间竖直延伸。Referring now to Figures 26A-26C, the example navigation sensor assembly (410) is provided in the form of a flexible printed circuit board (PCB) and includes a serpentine flexible circuit substrate (426) having a pair of sides positioned thereon Sensors (452, 453) and corresponding leads (not shown) are navigated distally adjacent. As shown, the base plate (426) extends longitudinally between the proximal and distal ends (440, 441), laterally between the first and second sides (442, 443), and between the top surface and the bottom surface. Extend vertically between surfaces (444,445).

基板(426)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或液晶聚合物(LCP)。例如,在期望维持基板(426)的相对平坦构型的情况下,基板(426)可由聚酰亚胺形成,因为由聚酰亚胺形成的此类基板(426)可朝向自然平坦构型弹性偏置。另选地,在期望基板(426)的更复杂几何构型和/或增加的柔性的情况下,基板(426)可由LCP形成,因为由LCP形成的基板(426)可被热成形以适应此类复杂几何构型和/或提供增加的柔性,诸如用于允许导航传感器组件(410)与轴组件(104)的柔性部分(118)一起在直线构型与弯曲构型之间弯曲。在任何情况下,远侧导航传感器(452,453)可由形成在基板(426)的顶部表面(444)上的相应导电迹线(未示出)的同心环部分限定,并且能够操作以生成指示如上所述的相应导航传感器(452,453)的位置的信号。导航传感器组件(410)的大小合适地被设置成适配在轴组件(104)内,同时仍然准许用于工作通道(449)沿轴组件(104)延伸(例如,在导航传感器组件(410)上方)的空间,从而准许附加器械(例如,扩张导管和/或能量导管)、抽吸、流体等穿过邻近导航传感器组件(410)的开口远侧端部(120)。就这一点而言,至少与传统的线圈传感器相比,导航传感器组件(410)可具有相对低轮廓。在一些型式中,导航传感器组件(410)可具有大约50微米的厚度。Substrate (426) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (426), the substrate (426) may be formed from polyimide because such a substrate (426) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (426) are desired, substrate (426) may be formed from LCP, as substrate (426) formed from LCP may be thermoformed to accommodate this. qua complex geometric configurations and/or provide increased flexibility, such as to allow the navigation sensor assembly (410) together with the flexible portion (118) of the shaft assembly (104) to flex between a straight configuration and a curved configuration. In any event, the distal navigation sensors (452, 453) may be partially defined by concentric rings of corresponding conductive traces (not shown) formed on the top surface (444) of the substrate (426) and be operable to generate an indication as described above. signals of the position of the corresponding navigation sensors (452, 453) described above. The navigation sensor assembly (410) is appropriately sized to fit within the shaft assembly (104) while still allowing for a working channel (449) to extend along the shaft assembly (104) (e.g., within the navigation sensor assembly (410) above), thereby permitting additional instrumentation (eg, dilation catheters and/or energy catheters), suction, fluids, etc. to pass through the open distal end (120) adjacent the navigation sensor assembly (410). In this regard, the navigation sensor assembly (410) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (410) may have a thickness of approximately 50 microns.

应当了解,与导航传感器组件(110)的基板(126)的大致矩形构型相比,基板(426)的蛇形构型可为导航传感器组件(410)提供减小的几何约束和提高的灵活性。因此,基板(426)可用于期望基板(426)的更复杂的几何构型和/或增加的柔性的情况,诸如用于可延展的或可定向的装置(如轴组件(104)的柔性部分(118))。It will be appreciated that the serpentine configuration of the base plate (426) of the navigation sensor assembly (110) may provide the navigation sensor assembly (410) with reduced geometric constraints and increased flexibility compared to the generally rectangular configuration of the base plate (126) of the navigation sensor assembly (110). sex. Accordingly, base plate (426) may be used in situations where more complex geometries and/or increased flexibility of base plate (426) are desired, such as for use in flexible portions of a malleable or orientable device such as shaft assembly (104) (118)).

如图26A最佳所见,导航传感器组件(410)初始可具有大致平坦构型,诸如当初始形成基板(426)时和/或在远侧导航传感器(452,453)初始定位在该基板上期间。如图所示,纵向中心线(C)沿基板(426)延伸。如图26B最佳所见,导航传感器组件(410)可呈现侧向弯曲、纵向直线构型,在该构型中,基板(426)的侧(442,443)从纵向中心线(C)向上弯曲,导航传感器组件(410)在纵向方向上延伸。因此,当设置在柔性部分(118)内时,导航传感器组件(410)可围绕轴组件(104)的柔性部分(118)的纵向轴线以对应于柔性部分(118)的柱形内表面的曲率半径的曲率半径弯曲,以由此适形于柔性部分(118)的内圆周。如图26C最佳所见,导航传感器组件(410)可呈现侧向弯曲、纵向弯曲构型,在该构型中,基板(426)的侧(442,443)从纵向中心线(C)向上弯曲,导航传感器组件(410)至少部分地从纵向方向偏转。当轴组件(104)的柔性部分(118)处于其直线构型时,导航传感器组件(410)可处于其侧向弯曲、纵向直线构型,并且当轴组件(104)的柔性部分(118)处于其弯曲构型时,导航传感器组件(410)可处于其侧向弯曲、纵向弯曲构型。这样,导航传感器组件(410)可适应柔性部分(118)在其直线构型与弯曲构型之间的弯曲,使得无论柔性部分(118)是处于其直线构型还是弯曲构型均可执行柔性部分(118)的导航。As best seen in Figure 26A, navigation sensor assembly (410) may initially have a generally flat configuration, such as when substrate (426) is initially formed and/or during initial positioning of distal navigation sensors (452, 453) on the substrate. As shown, a longitudinal centerline (C) extends along the base plate (426). As best seen in Figure 26B, the navigation sensor assembly (410) may assume a laterally curved, longitudinally straight configuration in which the sides (442, 443) of the base plate (426) curve upward from the longitudinal centerline (C), The navigation sensor assembly (410) extends in the longitudinal direction. Accordingly, when disposed within the flexible portion (118), the navigation sensor assembly (410) can be arranged about the longitudinal axis of the flexible portion (118) of the shaft assembly (104) to correspond to the curvature of the cylindrical inner surface of the flexible portion (118). The radius of curvature is curved to thereby conform to the inner circumference of the flexible portion (118). As best seen in Figure 26C, the navigation sensor assembly (410) can assume a laterally curved, longitudinally curved configuration in which the sides (442, 443) of the base plate (426) curve upward from the longitudinal centerline (C), The navigation sensor assembly (410) is at least partially deflected from the longitudinal direction. The navigation sensor assembly (410) may be in its laterally curved, longitudinally straight configuration when the flexible portion (118) of the shaft assembly (104) is in its straight configuration, and when the flexible portion (118) of the shaft assembly (104) When in its curved configuration, the navigation sensor assembly (410) may be in its laterally curved, longitudinally curved configurations. In this manner, the navigation sensor assembly (410) can accommodate bending of the flexible portion (118) between its straight configuration and its curved configuration, such that the flexure can be performed regardless of whether the flexible portion (118) is in its straight configuration or its curved configuration. Navigation of section (118).

在所示示例中,远侧导航传感器(452,453)定位在轴组件(104)的远侧端部(120)处或附近,以便于远侧端部(120)的导航。然而,应当了解,导航传感器(452,453)可定位在相对于期望导航的器械(400)的部件的任何其他合适的位置处。还应当了解,一个远侧导航传感器(452,453)可设置在轴组件(104)的柔性部分(118)的第一侧向侧上,并且另一个远侧导航传感器(452,453)可设置在轴组件(104)的柔性部分(118)的第二侧向侧上。这样,远侧导航传感器(452,453)可提供指示柔性部分(118)的两个侧向侧的位置的位置相关信号,这可提高由处理器(52)计算的位置坐标的准确性,诸如当柔性部分(118)处于弯曲构型时。在一些型式中,可提供仅单个远侧导航传感器(452,453)。在其他型式中,可提供一个或多个近侧顶部导航传感器(未示出)。在仍其他型式中,远侧底部导航传感器和/或近侧底部导航传感器(未示出)可设置在与对应的顶部导航传感器(452,453)相对的基板(426)的底部表面(445)上,诸如用于减少或消除如上所述的电磁噪声。一些变型还可提供位于柔性部分(118)远侧的一个或多个导航传感器(452,453)与位于柔性部分(118)近侧的另一个或多个导航传感器(452,453)的组合。In the example shown, distal navigation sensors (452, 453) are positioned at or near the distal end (120) of the shaft assembly (104) to facilitate navigation of the distal end (120). However, it should be appreciated that the navigation sensors (452, 453) may be positioned at any other suitable location relative to the components of the instrument (400) over which navigation is desired. It will also be appreciated that one distal navigation sensor (452, 453) can be disposed on the first lateral side of the flexible portion (118) of the shaft assembly (104) and another distal navigation sensor (452, 453) can be disposed on the shaft assembly ( 104) on the second lateral side of the flexible portion (118). In this manner, the distal navigation sensors (452, 453) may provide position-related signals indicative of the positions of the two lateral sides of the flexible portion (118), which may improve the accuracy of the position coordinates calculated by the processor (52), such as when the flexure Section (118) is in a curved configuration. In some versions, only a single far side navigation sensor (452, 453) may be provided. In other versions, one or more proximal top navigation sensors (not shown) may be provided. In still other versions, a distal bottom navigation sensor and/or a proximal bottom navigation sensor (not shown) may be disposed on a bottom surface (445) of the base plate (426) opposite a corresponding top navigation sensor (452, 453), Such as for reducing or eliminating electromagnetic noise as described above. Some variations may also provide a combination of one or more navigation sensors (452, 453) located distal to the flexible portion (118) with another one or more navigation sensors (452, 453) located proximal to the flexible portion (118).

虽然本示例的导航传感器组件(410)沿轴组件(104)的柔性部分(118)的大致柱形内表面设置,但是导航传感器组件(410)可另选地以至少一个大致弯曲构型沿轴组件(104)的柔性部分(118)的大致柱形外表面设置,在该至少一个大致弯曲构型中,导航传感器组件(110)围绕轴组件(104)的柔性部分(118)的纵向轴线以对应于柔性部分(118)的柱形外表面的曲率半径的曲率半径弯曲,以由此适形于柔性部分(118)的外圆周。在任何情况下,导航传感器组件(410)可准许用于工作通道(449)沿如上文所述的轴组件(104)延伸的空间,使得导航传感器组件(410)可在导管(例如,扩张导管或能量导管)通过工作通道(449)朝远侧推进期间和/或当此类导管保持定位在工作通道(449)内时(诸如在扩张导管的球囊充胀以扩张解剖通道期间和/或在RF能量经由能量导管的电极递送到组织期间)将位置相关信号连续地传送到处理器(52)。换句话说,柔性部分(118)的导航可与解剖通道的扩张同时进行和/或与RF能量向组织的递送同时进行,而不会彼此干扰。While the navigation sensor assembly (410) of this example is disposed along the generally cylindrical inner surface of the flexible portion (118) of the shaft assembly (104), the navigation sensor assembly (410) may alternatively be in at least one generally curved configuration along the shaft. The generally cylindrical outer surface of the flexible portion (118) of the assembly (104) is disposed, and in the at least one generally curved configuration, the navigation sensor assembly (110) is arranged about a longitudinal axis of the flexible portion (118) of the shaft assembly (104). The radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the flexible portion (118) is curved to thereby conform to the outer circumference of the flexible portion (118). In any event, the navigation sensor assembly (410) may permit space for the working channel (449) to extend along the shaft assembly (104) as described above, such that the navigation sensor assembly (410) may be used in a catheter (e.g., a dilation catheter). or energy catheter) distally through the working channel (449) and/or while such catheter remains positioned within the working channel (449), such as during balloon inflation of the dilation catheter to dilate the anatomical channel and/or Position-related signals are continuously transmitted to the processor (52) during delivery of RF energy to the tissue via the electrodes of the energy catheter. In other words, navigation of the flexible portion (118) can occur simultaneously with expansion of the anatomical passage and/or with delivery of RF energy to the tissue without interfering with each other.

D.带有蛇形柔性导航传感器组件的示例性抽吸器械D. Exemplary suction device with snake-shaped flexible navigation sensor assembly

图27A至图27C示出了器械(500)的示例,该器械可用于在外科规程期间提供抽吸,以便于移除解剖通道内或附近的外来物质和/或不期望物质(例如,流体和/或碎屑)。例如,器械(500)可用于在FESS规程、鼻窦成形术规程期间和/或在各种其他ENT规程中从鼻旁窦、喉、咽鼓管、耳、鼻或喉内的其他通道等清除流体和/或碎屑。该示例的器械(500)包括细长可延展轴(516)和导航传感器组件(510),该细长可延展轴从柄部(未示出)朝远侧延伸到开口远侧抽吸末端(520),该导航传感器组件可类似于导航传感器组件(410),除非另外描述。器械(500)可与抽吸源(未示出)耦接,该抽吸源能够操作以在手术部位处选择性地提供足够的抽吸,以将过量流体和/或碎屑朝近侧拉动通过器械(500)。从图27A到图27C的转变示出了可延展轴(516)从直线构型(图27A)弯曲到弯曲构型和双弯曲构型(分别为图27B和图27C),并且由此使远侧抽吸末端(520)侧向偏转远离可延展轴(516)的近侧纵向轴线。Figures 27A-27C illustrate an example of an instrument (500) that may be used to provide suction during a surgical procedure to facilitate removal of foreign and/or undesirable materials (e.g., fluids and /or debris). For example, instrument (500) may be used to clear fluid from the paranasal sinuses, larynx, Eustachian tube, ear, nose, or other passages within the throat, etc., during a FESS procedure, a sinuplasty procedure, and/or during various other ENT procedures. and/or debris. The instrument (500) of this example includes an elongate extendable shaft (516) that extends distally from a handle (not shown) to an open distal aspiration tip (510) and a navigation sensor assembly (510). 520), which navigation sensor assembly may be similar to navigation sensor assembly (410) unless otherwise described. Instrument (500) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw excess fluid and/or debris proximally. By instrument (500). The transition from Figure 27A to Figure 27C shows the extensible shaft (516) bending from a straight configuration (Figure 27A) to a curved configuration and a double curved configuration (Figures 27B and 27C, respectively), and thereby allowing the remote The side suction tip (520) deflects laterally away from the proximal longitudinal axis of the extensible shaft (516).

如图所示,导航传感器组件(510)设置在可延展轴(516)的外部上并且能够操作以向可延展轴(516)提供导航能力。更具体地,导航传感器组件(510)以至少一个大致弯曲构型沿可延展轴(516)的大致柱形外表面设置,在该至少一个大致弯曲构型中,导航传感器组件(510)围绕可延展轴(516)的纵向轴线以对应于可延展轴(516)的柱形外表面的曲率半径的曲率半径弯曲,以由此适形于可延展轴(516)的外圆周。As shown, a navigation sensor assembly (510) is disposed on the exterior of the extendable shaft (516) and is operable to provide navigation capabilities to the extendable shaft (516). More specifically, the navigation sensor assembly (510) is disposed along the generally cylindrical outer surface of the extensible shaft (516) in at least one generally curved configuration in which the navigation sensor assembly (510) surrounds the extensible shaft (516). The longitudinal axis of the extendable shaft (516) is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the extendable shaft (516) to thereby conform to the outer circumference of the extendable shaft (516).

该示例的导航传感器组件(510)以柔性印刷电路板(PCB)的形式提供,并且包括蛇形柔性电路基板(526),该蛇形柔性电路基板上定位有一对侧向相邻的远侧导航传感器(552,553)和对应的引线(未示出)。如图所示,基板(526)在近侧端部与远侧端部(540,541)之间纵向延伸,在第一侧与第二侧(542,543)之间侧向延伸,并且在顶部表面(544)与底部表面(未示出)之间竖直延伸。The navigation sensor assembly (510) of this example is provided in the form of a flexible printed circuit board (PCB) and includes a serpentine flexible circuit substrate (526) on which a pair of laterally adjacent distal navigation sensors are positioned. Sensors (552, 553) and corresponding leads (not shown). As shown, base plate (526) extends longitudinally between proximal and distal ends (540,541), laterally between first and second sides (542,543), and on top surface (544 ) and the bottom surface (not shown) extending vertically.

基板(526)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或液晶聚合物(LCP)。例如,在期望维持基板(526)的相对平坦构型的情况下,基板(526)可由聚酰亚胺形成,因为由聚酰亚胺形成的此类基板(526)可朝向自然平坦构型弹性偏置。另选地,在期望基板(526)的更复杂几何构型和/或增加的柔性的情况下,基板(526)可由LCP形成,因为由LCP形成的基板(526)可被热成形以适应此类复杂几何构型和/或提供增加的柔性,诸如用于允许导航传感器组件(510)与可延展轴(516)一起在直线构型、弯曲构型和双弯曲构型之间弯曲。在任何情况下,远侧导航传感器(552,553)可由形成在基板(526)的顶部表面(544)上的相应导电迹线(未示出)的同心环部分限定,并且能够操作以生成指示如上所述的相应导航传感器(552,553)的位置的信号。导航传感器组件(510)的大小合适地被设置成适配在可延展轴(516)的外部上,而不阻塞沿可延展轴(516)延伸的工作通道(549),从而准许附加器械、抽吸、流体等穿过开口远侧抽吸末端(520),同时还保持与可延展轴(516)的外部大致齐平以使钩住组织的风险最小化。就这一点而言,至少与传统的线圈传感器相比,导航传感器组件(510)可具有相对低轮廓。在一些型式中,导航传感器组件(510)可具有大约50微米的厚度。Substrate (526) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (526), the substrate (526) may be formed from polyimide because such a substrate (526) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (526) are desired, substrate (526) may be formed from LCP, as substrate (526) formed from LCP may be thermoformed to accommodate this. qua complex geometric configurations and/or provide increased flexibility, such as to allow the navigation sensor assembly (510) with the extensible shaft (516) to flex between straight configurations, curved configurations, and double curved configurations. In any case, the distal navigation sensors (552, 553) may be partially defined by concentric rings of corresponding conductive traces (not shown) formed on the top surface (544) of the substrate (526) and be operable to generate an indication as described above. signals of the position of the corresponding navigation sensors (552, 553) described above. The navigation sensor assembly (510) is appropriately sized to fit over the exterior of the extendable shaft (516) without blocking the working channel (549) extending along the extendable shaft (516), thereby permitting additional instrumentation, extraction Suction, fluid, etc. is passed through the open distal suction tip (520) while still remaining generally flush with the exterior of the extendable shaft (516) to minimize the risk of snagging tissue. In this regard, the navigation sensor assembly (510) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (510) may have a thickness of approximately 50 microns.

在一些型式中,导航传感器组件(510)初始可具有与导航传感器组件(410)的构型类似的大致平坦构型(未示出),诸如当初始形成基板(526)时和/或在远侧导航传感器(552,553)初始定位在该基板上期间。如图27A最佳所见,导航传感器组件(510)可呈现侧向弯曲、纵向直线构型,在该构型中,基板(526)的侧(542,543)从基板(526)的纵向中心线(未示出)向下弯曲,导航传感器组件(510)在纵向方向上延伸。因此,当设置在可延展轴(516)的外部上时,导航传感器组件(510)可围绕可延展轴(516)的纵向轴线以对应于可延展轴(516)的柱形外表面的曲率半径的曲率半径弯曲,以由此适形于可延展轴(516)的外圆周。In some versions, navigation sensor assembly (510) may initially have a generally flat configuration (not shown) similar to the configuration of navigation sensor assembly (410), such as when substrate (526) is initially formed and/or at a remote location. During initial positioning of side navigation sensors (552,553) on the substrate. As best seen in Figure 27A, the navigation sensor assembly (510) may assume a laterally curved, longitudinally straight configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline (526) of the base plate (526). (not shown) is bent downward, and the navigation sensor assembly (510) extends in the longitudinal direction. Accordingly, when disposed on the exterior of extensible shaft (516), navigation sensor assembly (510) may be arranged about the longitudinal axis of extensible shaft (516) with a radius of curvature corresponding to the cylindrical outer surface of extensible shaft (516) with a radius of curvature to thereby conform to the outer circumference of the extensible shaft (516).

如图27B最佳所见,导航传感器组件(510)可呈现侧向弯曲、纵向弯曲构型,在该构型中,基板(526)的侧(542,543)从基板(526)的纵向中心线向下弯曲,导航传感器组件(510)在沿其长度的第一位置处至少部分地从纵向方向偏转。As best seen in Figure 27B, the navigation sensor assembly (510) can assume a laterally curved, longitudinally curved configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline of the base plate (526) to the longitudinal centerline of the base plate (526). Curved downward, the navigation sensor assembly (510) is at least partially deflected from the longitudinal direction at a first location along its length.

如图27C最佳所见,导航传感器组件(510)可呈现侧向弯曲、纵向双弯曲构型,在该构型中,基板(526)的侧(542,543)从基板(526)的纵向中心线向下弯曲,导航传感器组件(510)在沿其长度的第一位置和第二位置处至少部分地从纵向方向偏转。当可延展轴(516)处于其直线构型时,导航传感器组件(510)可处于其侧向弯曲、纵向直线构型,当可延展轴(516)处于其弯曲构型时,导航传感器组件(510)可处于其侧向弯曲、纵向弯曲构型,并且当可延展轴(516)处于其双弯曲构型时,导航传感器组件(510)可处于其侧向弯曲、纵向双弯曲构型。这样,导航传感器组件(510)可适应可延展轴(516)在其直线构型、弯曲构型和双弯曲构型之间的弯曲,使得无论可延展轴(516)是处于其直线构型、弯曲构型还是双弯曲构型均可执行可延展轴(516)的导航。As best seen in Figure 27C, the navigation sensor assembly (510) can assume a laterally curved, longitudinally double curved configuration in which the sides (542, 543) of the base plate (526) extend from the longitudinal centerline of the base plate (526) Curved downward, the navigation sensor assembly (510) is at least partially deflected from the longitudinal direction at first and second positions along its length. The navigation sensor assembly (510) may be in its laterally curved, longitudinally straight configuration when the extensible shaft (516) is in its straight configuration, and when the extensible shaft (516) is in its curved configuration, the navigation sensor assembly (510) may be in its laterally curved, longitudinally straight configuration. 510) may be in its laterally bent, longitudinally bent configuration, and the navigation sensor assembly (510) may be in its laterally bent, longitudinally bent configuration when the extensible shaft (516) is in its double bent configuration. In this way, the navigation sensor assembly (510) can accommodate bending of the extensible shaft (516) between its straight configuration, a curved configuration, and a double-bent configuration, such that whether the extensible shaft (516) is in its straight configuration, Navigation of the extensible shaft (516) may be performed in either a curved configuration or a double curved configuration.

在所示示例中,远侧导航传感器(552,553)定位在可延展轴(516)的远侧抽吸末端(520)处或附近,以便于远侧抽吸末端(520)的导航。然而,应当了解,导航传感器(552,553)可定位在相对于期望导航的器械(500)的部件的任何其他合适的位置处。还应当了解,一个远侧导航传感器(552,553)可设置在可延展轴(516)的第一侧向侧上,并且另一个远侧导航传感器(552,553)可设置在可延展轴(516)的第二侧向侧上。这样,远侧导航传感器(552,553)可提供指示可延展轴(516)的两个侧向侧的位置的位置相关信号,这可提高由处理器(52)计算的位置坐标的准确性,诸如当可延展轴(516)处于弯曲构型和/或双弯曲构型时。在一些型式中,可提供仅单个远侧导航传感器(552,553)。在其他型式中,可提供一个或多个近侧顶部导航传感器(未示出)。在仍其他型式中,远侧底部导航传感器和/或近侧底部导航传感器(未示出)可设置在与对应的顶部导航传感器(552,553)相对的基板(526)的底部表面(545)上,诸如用于减少或消除如上所述的电磁噪声。一些型式还可提供位于沿可延展轴(516)的长度的各种纵向位置处的若干导航传感器(552,553)。此类定位可使得IGS导航系统(50)能够确定可延展轴(516)在患者(P)体内的整个长度的位置和取向,而不管操作者已将何种特定弯曲构型应用于可延展轴(516)。In the example shown, distal navigation sensors (552, 553) are positioned at or near the distal suction tip (520) of the extensible shaft (516) to facilitate navigation of the distal suction tip (520). However, it should be appreciated that the navigation sensors (552, 553) may be positioned at any other suitable location relative to the components of the instrument (500) over which navigation is desired. It should also be appreciated that one distal navigation sensor (552,553) may be disposed on a first lateral side of the extensible shaft (516) and another distal navigation sensor (552,553) may be disposed on a first lateral side of the extensible shaft (516). Two sides to the side. In this manner, the distal navigation sensors (552, 553) may provide position-related signals indicative of the positions of the two lateral sides of the extensible axis (516), which may improve the accuracy of the position coordinates calculated by the processor (52), such as when The extensible shaft (516) is in a curved configuration and/or a dual-bent configuration. In some versions, only a single far side navigation sensor (552,553) may be provided. In other versions, one or more proximal top navigation sensors (not shown) may be provided. In still other versions, a distal bottom navigation sensor and/or a proximal bottom navigation sensor (not shown) may be disposed on the bottom surface (545) of the base plate (526) opposite the corresponding top navigation sensor (552,553), Such as for reducing or eliminating electromagnetic noise as described above. Some versions may also provide a number of navigation sensors (552, 553) located at various longitudinal positions along the length of the extendable axis (516). Such positioning may enable the IGS navigation system (50) to determine the position and orientation of the extensible shaft (516) throughout the length of the patient (P), regardless of the specific bending configuration that the operator has applied to the extensible shaft. (516).

虽然本示例的导航传感器组件(510)沿可延展轴(516)的大致柱形外表面设置,但是导航传感器组件(510)可另选地以至少一个大致弯曲构型沿可延展轴(516)的大致柱形内表面设置,在该至少一个大致弯曲构型中,导航传感器组件(510)围绕可延展轴(516)的纵向轴线以对应于可延展轴(516)的柱形内表面的曲率半径的曲率半径弯曲,以由此适形于可延展轴(516)的内圆周。在任何情况下,导航传感器组件(510)可准许用于工作通道(549)沿如上所述的可延展轴(516)延伸的空间,使得导航传感器组件(510)可在通过工作通道(549)朝近侧抽吸流体和/或碎屑期间将位置相关信号连续地传送到处理器(52),以从解剖通道内或附近清除此类流体和/或碎屑。换句话说,从解剖通道移除流体和/或碎屑与可延展轴(516)的导航可同时进行,而不会彼此干扰。While the navigation sensor assembly (510) of this example is disposed along the generally cylindrical outer surface of the extensible axis (516), the navigation sensor assembly (510) may alternatively be in at least one generally curved configuration along the extensible axis (516). In the at least one generally curved configuration, the navigation sensor assembly (510) is disposed about the longitudinal axis of the extensible shaft (516) with a curvature corresponding to the curvature of the cylindrical inner surface of the extensible shaft (516). The radius of curvature is curved to thereby conform to the inner circumference of the extensible shaft (516). In any event, the navigation sensor assembly (510) may permit space for the working channel (549) to extend along the extensible axis (516) as described above, such that the navigation sensor assembly (510) may pass through the working channel (549). Position-related signals are continuously transmitted to the processor (52) during proximal aspiration of fluid and/or debris to clear such fluid and/or debris from within or adjacent the anatomical passage. In other words, removal of fluid and/or debris from the anatomical passage and navigation of the extensible shaft (516) can occur simultaneously without interfering with each other.

虽然导航传感器组件(510)被示出为结合到器械(500)中以提供抽吸,但是应当了解,导航传感器组件(510)可结合到任何其他合适的外科器械中,诸如用于在ENT规程期间执行其他功能的器械,包括例如具有可延展轴的探测器械或刮匙器械。Although navigation sensor assembly (510) is shown incorporated into instrument (500) to provide suction, it should be understood that navigation sensor assembly (510) may be incorporated into any other suitable surgical instrument, such as for use during ENT procedures. Instruments that perform other functions during the operation, including, for example, probing instruments or curette instruments with extensible shafts.

E.带有直的柔性导航传感器组件的示例性剃刮器械E. Exemplary shaving instrument with straight flexible navigation sensor assembly

图28至图37示出了可用于从解剖通道切断并移除组织(诸如骨组织)的器械(600)的示例。例如,器械(600)可用于从鼻腔以及从任何其他合适位置切断和移除骨组织和邻近的粘膜组织。该示例的器械(600)包括柄部组件(602)、毂(603)、轴组件(604)和导航传感器组件(610),该导航传感器组件可类似于导航传感器组件(110),除非另外描述。器械(600)可与抽吸源(未示出)耦接,该抽吸源能够操作以在手术部位处选择性地提供足够的抽吸,以将切断的组织朝近侧拉动通过器械(600)。Figures 28-37 illustrate examples of instruments (600) that can be used to sever and remove tissue, such as bone tissue, from an anatomical passage. For example, instrument (600) may be used to sever and remove bone tissue and adjacent mucosal tissue from the nasal cavity, as well as from any other suitable location. The example instrument (600) includes a handle assembly (602), a hub (603), a shaft assembly (604), and a navigation sensor assembly (610), which may be similar to the navigation sensor assembly (110) unless otherwise described. . Instrument (600) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw severed tissue proximally through instrument (600) ).

该示例的柄部组件(602)包括主体(612),该主体的大小和构型被设置成由操作者的单手抓握和操作,诸如经由电动握把、铅笔握把或任何其他合适种类的握把。柄部组件(602)可包括用于操作器械(600)的控件,或者控件可远程定位。器械(600)还包括可操作地连接到抽吸源并且被构造成能够从外科手术部位吸出组织(诸如骨组织)的抽吸口(613)。旋转运动可由柄部组件(602)中的机动驱动组件(未示出)递送到轴组件(604),尽管可利用任何合适的旋转或振荡运动源。例如,此运动源可容纳在柄部组件(602)内,或者可以是外部的并且可连接到柄部组件(602)。功率源(未示出)可连接到机动驱动组件以向器械(600)供电以供使用。另外或另选地,柄部组件(602)可容纳电池(未示出)。The handle assembly (602) of this example includes a body (612) sized and configured to be grasped and manipulated by one hand of an operator, such as via a power grip, pencil grip, or any other suitable kind grip. The handle assembly (602) may include controls for operating the instrument (600), or the controls may be remotely located. The instrument (600) also includes a suction port (613) operably connected to the suction source and configured to aspirate tissue, such as bone tissue, from the surgical site. Rotational motion may be delivered to shaft assembly (604) by a motorized drive assembly (not shown) in handle assembly (602), although any suitable source of rotational or oscillatory motion may be utilized. For example, this source of motion may be contained within the handle assembly (602), or may be external and connectable to the handle assembly (602). A power source (not shown) can be connected to the motorized drive assembly to power the instrument (600) for use. Additionally or alternatively, the handle assembly (602) may accommodate a battery (not shown).

轴组件(604)通常包括共同被构造成接纳和移除来自外科手术部位的组织的纵向直的刚性外轴(616)和内切割构件(618)。可包括管的切割构件(618)设置在外轴(616)的纵向延伸内腔内并且被构造成在远侧部分处围绕轴组件(604)的纵向轴线旋转。切割构件(618)限定内腔并且朝近侧延伸到柄部组件(612)并且连接到机动驱动组件,该机动驱动组件相对于外轴(616)可旋转地驱动切割构件(618)。外轴(616)包括被构造成与内切割构件(618)的切割窗开口(未示出)协作的侧向轴窗开口(621)。此类构型能够根据2019年12月26日公布的名称为“Surgical Shaver with Feature to Detect Window State”的美国公布2019/0388117号的教导内容中的任何教导内容来构造和操作。Shaft assembly (604) generally includes a longitudinally straight rigid outer shaft (616) and an inner cutting member (618) that are collectively configured to receive and remove tissue from a surgical site. A cutting member (618), which may include a tube, is disposed within a longitudinally extending lumen of the outer shaft (616) and is configured to rotate about the longitudinal axis of the shaft assembly (604) at the distal portion. The cutting member (618) defines a lumen and extends proximally to the handle assembly (612) and is connected to a motorized drive assembly that rotatably drives the cutting member (618) relative to the outer shaft (616). The outer shaft (616) includes a lateral shaft window opening (621) configured to cooperate with a cutting window opening (not shown) of the inner cutting member (618). Such configurations can be constructed and operated according to any of the teachings in US Publication No. 2019/0388117 titled "Surgical Shaver with Feature to Detect Window State" published on December 26, 2019.

轴组件(604)也能够相对于柄部组件(610)围绕轴组件(604)的纵向轴线旋转。此类旋转可经由旋转控制旋钮(614)驱动,该旋转控制旋钮与柄部组件(610)的主体(612)可旋转地耦接。另选地,轴组件(604)可经由一些其他形式的使用者输入来旋转;或者可相对于柄部组件(610)不可旋转。还应当理解,本文所述的柄部组件(610)的示例仅是例示性示例。轴组件(604)可替代地与任何其他合适种类的柄部组件或其他支撑主体耦接。The shaft assembly (604) is also rotatable relative to the handle assembly (610) about the longitudinal axis of the shaft assembly (604). Such rotation may be driven via a rotary control knob (614) that is rotatably coupled to the body (612) of the handle assembly (610). Alternatively, shaft assembly (604) may be rotatable via some other form of user input; or may be non-rotatable relative to handle assembly (610). It should also be understood that the examples of handle assembly (610) described herein are illustrative examples only. The shaft assembly (604) may alternatively be coupled with any other suitable kind of handle assembly or other support body.

如图29最佳所示,导航传感器组件(610)设置在外轴(616)的外部上并且能够操作以向外轴(616)提供导航能力。更具体地,导航传感器组件(610)以大致弯曲构型沿外轴(616)的大致柱形外表面设置,在该大致弯曲构型中,导航传感器组件(610)围绕外轴(616)的纵向轴线以对应于外轴(616)的柱形外表面的曲率半径的曲率半径弯曲,以由此适形于外轴(616)的外圆周。在一些型式中,器械(600)可包括围绕导航传感器组件(610)径向向外的外轴(616)的至少一部分同轴定位的护套(未示出),使得导航传感器组件(610)可夹在护套与外轴(616)之间。As best shown in Figure 29, navigation sensor assembly (610) is disposed on the exterior of outer shaft (616) and is operable to provide navigation capabilities to outer shaft (616). More specifically, the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer shaft (616) in a generally curved configuration in which the navigation sensor assembly (610) surrounds the outer shaft (616). The longitudinal axis is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the outer shaft (616) to thereby conform to the outer circumference of the outer shaft (616). In some versions, the instrument (600) may include a sheath (not shown) coaxially positioned about at least a portion of the radially outward outer shaft (616) of the navigation sensor assembly (610) such that the navigation sensor assembly (610) Can be sandwiched between the sheath and the outer shaft (616).

现在参考图30至图37,该示例的导航传感器组件(610)以柔性印刷电路板(PCB)的形式提供,并且包括细长的、大致矩形的柔性电路基板(626),该柔性电路基板上形成(例如,印刷和/或嵌入)有多个迹线(630,632,633,634,636,637)、多个对应的迹线引线(638a,638b,638c,638d,638e,638f)以及多个接地引线(639a,639b)。如图所示,基板(626)在近侧端部与远侧端部(640,641)之间纵向延伸,在第一侧与第二侧(642,643)之间侧向延伸,并且在顶部表面与底部表面(644,645)之间竖直延伸。本示例的基板(626)包括在顶部表面与底部表面(644,645)之间延伸的多个通孔(646)。通孔(646)可被构造成接纳相应的销(未示出)或其他合适的紧固件,以将导航传感器组件(610)固定到柔性外轴(616)和/或器械(600)的任何其他部件。在所示型式中,基板(626)还包括在近侧端部(640)与第一侧(642)之间延伸的近侧斜面(648)。近侧斜面(648)可被构造成有助于将近侧端部(640)定位在相对于外轴(616)和/或相对于器械(600)的任何其他部件的期望位置处。Referring now to FIGS. 30-37 , the navigation sensor assembly (610) of this example is provided in the form of a flexible printed circuit board (PCB) and includes an elongated, generally rectangular flexible circuit substrate (626) on which Formed (eg, printed and/or embedded) are a plurality of traces (630, 632, 633, 634, 636, 637), a plurality of corresponding trace leads (638a, 638b, 638c, 638d, 638e, 638f), and a plurality of ground leads (639a, 639b). As shown, the base plate (626) extends longitudinally between the proximal and distal ends (640, 641), laterally between the first and second sides (642, 643), and between the top surface and the bottom surface. Extend vertically between surfaces (644,645). The substrate (626) of this example includes a plurality of vias (646) extending between top and bottom surfaces (644, 645). Through-hole (646) may be configured to receive corresponding pins (not shown) or other suitable fasteners to secure navigation sensor assembly (610) to flexible outer shaft (616) and/or to the instrument (600) any other parts. In the version shown, the base plate (626) also includes a proximal ramp (648) extending between the proximal end (640) and the first side (642). Proximal ramp (648) may be configured to facilitate positioning proximal end (640) at a desired location relative to outer shaft (616) and/or relative to any other components of instrument (600).

基板(626)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或液晶聚合物(LCP)。例如,在期望维持基板(626)的相对平坦构型的情况下,基板(626)可由聚酰亚胺形成,因为由聚酰亚胺形成的此类基板(626)可朝向自然平坦构型弹性偏置。另选地,在期望基板(626)的更复杂几何构型和/或增加的柔性的情况下,基板(626)可由LCP形成,因为由LCP形成的基板(626)可被热成形以适应此类复杂几何构型和/或提供增加的柔性。在任何情况下,迹线(630,632,633,634,636,637)和引线(638a,638b,638c,638d,638e,638f)均可由诸如铜的导电金属材料形成。导航传感器组件(610)的大小合适地被设置成适配在外轴(616)的外部上,而不阻塞外轴(616)的内腔,从而准许内切割构件(618)可旋转地设置在该内腔中,同时还保持与外轴(616)的外部大致齐平以使钩住组织的风险最小化。就这一点而言,至少与传统的线圈传感器相比,导航传感器组件(610)可具有相对低轮廓。在一些型式中,导航传感器组件(610)可具有大约50微米的厚度。Substrate (626) may be formed from an electrically insulating flexible plastic material, such as polyimide or liquid crystal polymer (LCP). For example, where it is desired to maintain a relatively flat configuration of the substrate (626), the substrate (626) may be formed from polyimide because such a substrate (626) formed from polyimide may be resilient toward a naturally flat configuration. bias. Alternatively, where more complex geometries and/or increased flexibility of substrate (626) are desired, substrate (626) may be formed from LCP, as substrate (626) formed from LCP may be thermoformed to accommodate this. resemble complex geometries and/or provide increased flexibility. In any case, traces (630, 632, 633, 634, 636, 637) and leads (638a, 638b, 638c, 638d, 638e, 638f) may be formed from a conductive metallic material such as copper. The navigation sensor assembly (610) is appropriately sized to fit over the exterior of the outer shaft (616) without blocking the lumen of the outer shaft (616), thereby allowing the inner cutting member (618) to be rotatably disposed thereon. in the lumen while also remaining generally flush with the exterior of the outer shaft (616) to minimize the risk of snagging tissue. In this regard, the navigation sensor assembly (610) may have a relatively low profile, at least compared to traditional coil sensors. In some versions, navigation sensor assembly (610) may have a thickness of approximately 50 microns.

如图30和图31所示,迹线(630,632,633,634,636,637)包括各自形成在基板(626)的顶部表面(644)上的近侧顶部迹线(630)、第一远侧顶部迹线(632)和第二远侧顶部迹线(633),以及各自形成在基板(626)的底部表面(645)上的与对应的顶部迹线(630,632,633)相对和/或平行的近侧底部迹线(634)、第一远侧底部迹线(636)和第二远侧底部迹线(637)。类似地,引线(638a,638b,638c,638d,638e,638f)包括各自形成在基板(626)的顶部表面(644)上的近侧顶部引线(638a)以及第一远侧顶部引线和第二远侧顶部引线(638b,638c);以及各自形成在基板(626)的底部表面(645)上的与对应的顶部引线(638a,638b,638c)相对和/或平行的近侧底部引线(638d)以及第一远侧底部引线和第二远侧底部引线(638e,638f)。接地引线(639a,639b)包括各自形成在基板(626)的顶部表面(644)上的第一接地引线和第二接地引线(639a,639b)。顶部迹线(630,632,633)、顶部引线(638a,638b,638c)和接地引线(639a,639b)共同限定导航传感器组件(610)的顶部柔性电路层,而底部迹线(634,636,637)和底部引线(638d,638e,638f)共同限定导航传感器组件(610)的底部柔性电路层。As shown in Figures 30 and 31, traces (630, 632, 633, 634, 636, 637) include a proximal top trace (630), a first distal top trace (632), and A second distal top trace (633), and a proximal bottom trace (634) each formed on the bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top trace (630, 632, 633) , a first distal bottom trace (636) and a second distal bottom trace (637). Similarly, leads (638a, 638b, 638c, 638d, 638e, 638f) include a proximal top lead (638a) and first and second distal top leads, each formed on a top surface (644) of the substrate (626). distal top leads (638b, 638c); and proximal bottom leads (638d) each formed on the bottom surface (645) of the substrate (626) opposite and/or parallel to the corresponding top lead (638a, 638b, 638c) ) and the first and second distal bottom leads (638e, 638f). Ground leads (639a, 639b) include first and second ground leads (639a, 639b) each formed on the top surface (644) of the substrate (626). Top traces (630,632,633), top leads (638a, 638b, 638c), and ground leads (639a, 639b) collectively define the top flex circuit layer of the navigation sensor assembly (610), while bottom traces (634,636,637) and bottom leads (638d , 638e, 638f) together define the bottom flexible circuit layer of the navigation sensor assembly (610).

现在参考图32至图37,迹线(630,632,633,634,636,637)各自包括相应的第一纵向部分(630a,632a,633a,634a,636a,637a)、同心环部分(630b,632b,633b,634b,636b,637b)和第二纵向部分(630c,632c,633c,634c,636c,637c)。如图所示,远侧迹线(632,633,636,637)的同心环部分(632b,633b,636b,637b)相对于相应近侧迹线(630,634)的同心环部分(630b,634b)定位在远侧。Referring now to Figures 32-37, traces (630, 632, 633, 634, 636, 637) each include corresponding first longitudinal portions (630a, 632a, 633a, 634a, 636a, 637a), concentric ring portions (630b, 632b, 633b, 634b, 636b, 637b ) and the second longitudinal portion (630c, 632c, 633c, 634c, 636c, 637c). As shown, the concentric ring portions (632b, 633b, 636b, 637b) of the distal traces (632, 633, 636, 637) are positioned distally relative to the concentric ring portions (630b, 634b) of the corresponding proximal traces (630, 634).

近侧顶部引线(638a)电耦接到近侧顶部迹线(630)的第一纵向部分(630a)的近侧端部。近侧顶部迹线(630)的第一纵向部分(630a)从其近侧端部朝远侧延伸并且在其远侧端部处电耦接到近侧底部迹线(634)的第一纵向部分(634a)的远侧端部。近侧底部迹线(634)的第一纵向部分(634a)从其远侧端部朝向近侧底部引线(638d)朝近侧延伸,并且在其近侧端部处电耦接到近侧底部迹线(634)的第二纵向部分(634c)的近侧端部。近侧底部迹线(634)的第二纵向部分(634c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到近侧底部迹线(634)的同心环部分(634b)的径向外端。近侧底部迹线(634)的同心环部分(634b)从其径向外端径向向内螺旋,并且在其径向内端处电耦接到近侧顶部迹线(630)的同心环部分(630b)的径向内端。近侧顶部迹线(630)的同心环部分(630b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到近侧顶部迹线(630)的第二纵向部分(630c)的远侧端部。近侧顶部迹线(630)的第二纵向部分(630c)从其远侧端部朝向近侧顶部引线(638a)朝近侧延伸,并且在其近侧端部处电耦接到近侧底部引线(638d)。The proximal top lead (638a) is electrically coupled to the proximal end of the first longitudinal portion (630a) of the proximal top trace (630). A first longitudinal portion (630a) of the proximal top trace (630) extends distally from a proximal end thereof and is electrically coupled at a distal end thereof to a first longitudinal portion (630a) of the proximal bottom trace (634) The distal end of portion (634a). A first longitudinal portion (634a) of the proximal bottom trace (634) extends proximally from its distal end toward the proximal bottom lead (638d) and is electrically coupled to the proximal bottom at its proximal end The proximal end of the second longitudinal portion (634c) of the trace (634). A second longitudinal portion (634c) of the proximal bottom trace (634) extends distally from its proximal end and is electrically coupled at its distal end to the concentric ring of proximal bottom trace (634) Radially outer end of portion (634b). The concentric ring portion (634b) of the proximal bottom trace (634) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the concentric ring of the proximal top trace (630) Radially inner end of portion (630b). The concentric ring portion (630b) of the proximal top trace (630) spirals radially outward from its radially inner end and is electrically coupled at its radially outer end to a second portion (630b) of the proximal top trace (630). The distal end of the longitudinal portion (630c). A second longitudinal portion (630c) of the proximal top trace (630) extends proximally from its distal end toward the proximal top lead (638a) and is electrically coupled to the proximal bottom at its proximal end Lead (638d).

第一远侧顶部引线(638b)电耦接到第一远侧顶部迹线(632)的第一纵向部分(632a)的近侧端部。第一远侧顶部迹线(632)的第一纵向部分(632a)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到第一远侧底部迹线(636)的第一纵向部分(636a)的远侧端部。第一远侧底部迹线(636)的第一纵向部分(636a)从其远侧端部朝向第一远侧底部引线(638e)朝近侧延伸,并且在其近侧端部处电耦接到第一远侧底部迹线(636)的第二纵向部分(636c)的近侧端部。第一远侧底部迹线(636)的第二纵向部分(636c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到第一远侧底部迹线(636)的同心环部分(636b)的径向外端。第一远侧底部迹线(636)的同心环部分(636b)从其径向外端径向向内螺旋,并且在其径向内端处电耦接到第一远侧顶部迹线(632)的同心环部分(632b)的径向内端。第一远侧顶部迹线(632)的同心环部分(632b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到第一远侧顶部迹线(632)的第二纵向部分(632c)的远侧端部。第一远侧顶部迹线(632)的第二纵向部分(632c)从其远侧端部朝向第一远侧顶部引线(638b)朝近侧延伸,并且在其近侧端部处电耦接到第一远侧底部引线(638e)。The first distal top lead (638b) is electrically coupled to the proximal end of the first longitudinal portion (632a) of the first distal top trace (632). A first longitudinal portion (632a) of the first distal top trace (632) extends distally from its proximal end and is electrically coupled at its distal end to the first distal bottom trace (636 ) distal end of the first longitudinal portion (636a). A first longitudinal portion (636a) of the first distal bottom trace (636) extends proximally from its distal end toward the first distal bottom lead (638e) and is electrically coupled at its proximal end To the proximal end of the second longitudinal portion (636c) of the first distal bottom trace (636). A second longitudinal portion (636c) of the first distal bottom trace (636) extends distally from its proximal end and is electrically coupled at its distal end to the first distal bottom trace (636 ) of the radially outer end of the concentric ring portion (636b). The concentric ring portion (636b) of the first distal bottom trace (636) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the first distal top trace (632 ) of the radially inner end of the concentric ring portion (632b). The concentric ring portion (632b) of the first distal top trace (632) spirals radially outward from its radially inner end and is electrically coupled to the first distal top trace (632) at its radially outer end ) the distal end of the second longitudinal portion (632c). A second longitudinal portion (632c) of the first distal top trace (632) extends proximally from its distal end toward the first distal top lead (638b) and is electrically coupled at its proximal end to the first distal bottom lead (638e).

第二远侧顶部引线(638c)电耦接到第二远侧顶部迹线(633)的第一纵向部分(633a)的近侧端部。第二远侧顶部迹线(633)的第一纵向部分(633a)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到第二远侧底部迹线(637)的第一纵向部分(637a)的远侧端部。第二远侧底部迹线(637)的第一纵向部分(637a)从其远侧端部朝向第二远侧底部引线(638f)朝近侧延伸,并且在其近侧端部处电耦接到第二远侧底部迹线(637)的第二纵向部分(637c)的近侧端部。第二远侧底部迹线(637)的第二纵向部分(637c)从其近侧端部朝远侧延伸,并且在其远侧端部处电耦接到第二远侧底部迹线(637)的同心环部分(637b)的径向外端。第二远侧底部迹线(637)的同心环部分(637b)从其径向外端径向向内螺旋,并且在其径向内端处电耦接到第二远侧顶部迹线(633)的同心环部分(633b)的径向内端。第二远侧顶部迹线(633)的同心环部分(633b)从其径向内端径向向外螺旋,并且在其径向外端处电耦接到第二远侧顶部迹线(633)的第二纵向部分(633c)的远侧端部。第二远侧顶部迹线(633)的第二纵向部分(633c)从其远侧端部朝向第二远侧顶部引线(638c)朝近侧延伸,并且在其近侧端部处电耦接到第二远侧底部引线(638f)。The second distal top lead (638c) is electrically coupled to the proximal end of the first longitudinal portion (633a) of the second distal top trace (633). A first longitudinal portion (633a) of the second distal top trace (633) extends distally from its proximal end and is electrically coupled at its distal end to the second distal bottom trace (637 ) distal end of the first longitudinal portion (637a). A first longitudinal portion (637a) of the second distal bottom trace (637) extends proximally from its distal end toward the second distal bottom lead (638f) and is electrically coupled at its proximal end To the proximal end of the second longitudinal portion (637c) of the second distal bottom trace (637). A second longitudinal portion (637c) of the second distal bottom trace (637) extends distally from its proximal end and is electrically coupled at its distal end to the second distal bottom trace (637 ) of the radially outer end of the concentric ring portion (637b). The concentric ring portion (637b) of the second distal bottom trace (637) spirals radially inwardly from its radially outer end and is electrically coupled at its radially inner end to the second distal top trace (633 ) of the radially inner end of the concentric ring portion (633b). The concentric ring portion (633b) of the second distal top trace (633) spirals radially outward from its radially inner end and is electrically coupled to the second distal top trace (633) at its radially outer end. ) of the distal end of the second longitudinal portion (633c). A second longitudinal portion (633c) of the second distal top trace (633) extends proximally from its distal end toward the second distal top lead (638c) and is electrically coupled at its proximal end to the second distal bottom lead (638f).

以与上文所述的方式类似的方式,每个同心环部分(630b,632b,633b,634b,636b,637b)限定相应的导航传感器(650,652,653,654,656,657),该导航传感器能够操作以生成指示相应的导航传感器(650,652,653,654,656,657)的位置并且由此指示器械(500)的至少一部分(例如,外轴(616))在三维空间中的位置的信号。由此类位置相关信号生成的位置数据可由处理器(52)处理以用于向操作者提供视觉指示以实时地向操作者显示器械(600)的外轴(616)在患者(P)体内所位于的位置。此类视觉指示可被提供为在患者解剖结构的一个或多个术前获得的图像(例如,CT扫描)上的叠加。In a manner similar to that described above, each concentric ring portion (630b, 632b, 633b, 634b, 636b, 637b) defines a corresponding navigation sensor (650, 652, 653, 654, 656, 657) operable to generate an indication of the corresponding navigation The position of the sensor (650, 652, 653, 654, 656, 657) and thereby the signal indicating the position of at least a portion of the instrument (500) (eg, the outer shaft (616)) in three-dimensional space. Position data generated from such position-related signals may be processed by the processor (52) for providing a visual indication to the operator to show the operator in real time where the outer shaft (616) of the instrument (600) is within the patient (P). Located in the location. Such visual indications may be provided as an overlay on one or more preoperatively acquired images (eg, CT scans) of the patient's anatomy.

在所示示例中,远侧导航传感器(652,653,656,657)定位在外轴(616)的侧向轴窗口(621)处或附近,以便于侧向轴窗口(621)的导航,而近侧导航传感器(650,654)可定位在沿外轴(616)的任何合适位置处以有助于识别例如外轴(616))的方向和/或取向。然而,应当了解,导航传感器(650,652,653,654,656,657)可定位在相对于期望导航的器械(600)的部件的任何其他合适的位置处。同样在所示示例中,导航传感器组件(610)包括一对侧向相邻的远侧顶部导航传感器(652,653)和一对侧向相邻的远侧底部导航传感器(656,657)。此类一对远侧顶部导航传感器(652,653)和远侧底部导航传感器(656,657)可有助于提高由处理器(52)根据导航传感器(650,652,653,654,656,657)的位置相关信号计算的外轴(616))的位置坐标的准确性。就这一点而言,本型式的导航传感器组件(610)沿外轴(616)的大致柱形外表面设置,使得一个远侧顶部导航传感器(652,653)和一个远侧底部导航传感器(656,657)可设置在外轴(616)的第一侧向侧上,并且另一个远侧顶部导航传感器(652,653)和另一个远侧底部导航传感器(656,657)可设置在外轴(616)的第二侧向侧上。这样,一对远侧顶部导航传感器和远侧底部导航传感器(652,653,656,657)可提供指示外轴(616)的两个侧向侧的位置的位置相关信号,这可提高由处理器(52)计算的位置坐标的准确性。In the example shown, the distal navigation sensors (652, 653, 656, 657) are positioned at or near the lateral axis window (621) of the outer axis (616) to facilitate navigation of the lateral axis window (621), while the proximal navigation sensors (650,654 ) may be positioned at any suitable location along outer axis (616) to facilitate identification of, for example, the direction and/or orientation of outer axis (616)). However, it should be appreciated that the navigation sensors (650, 652, 653, 654, 656, 657) may be positioned at any other suitable location relative to the components of the instrument (600) over which navigation is desired. Also in the example shown, the navigation sensor assembly (610) includes a pair of laterally adjacent distal top navigation sensors (652, 653) and a pair of laterally adjacent distal bottom navigation sensors (656, 657). Such a pair of distal top navigation sensors (652,653) and distal bottom navigation sensors (656,657) may help improve the outer axis (616) calculated by the processor (52) based on position-related signals from the navigation sensors (650,652,653,654,656,657) The accuracy of the location coordinates. In this regard, the present version of the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer axis (616) such that a distal top navigation sensor (652, 653) and a distal bottom navigation sensor (656, 657) can disposed on a first lateral side of the outer shaft (616), and another distal top navigation sensor (652, 653) and another distal bottom navigation sensor (656, 657) may be disposed on a second lateral side of the outer shaft (616) . In this manner, a pair of distal top navigation sensors and distal bottom navigation sensors (652, 653, 656, 657) may provide position-related signals indicative of the position of the two lateral sides of the outer shaft (616), which may improve the calculation by the processor (52) Accuracy of location coordinates.

在一些型式中,限定在基板(626)的近侧端部和远侧端部(640,641)之间的导航传感器组件(610)的长度可足够大以将远侧导航传感器(652,653,656,657)定位在外轴(616)的侧向轴窗口(621)处或附近以便于侧向轴窗口(621)的导航,同时还将引线(638a,638b,638c,638d,638e,638f)定位在足够近侧的位置处,在该位置处引线(638a,638b,638c,638d,638e,638f)可直接电耦接到耦接单元(例如,无需插入电线或电缆)。就这一点而言,导航传感器组件(610)的长度可基本上等于或大于轴组件(604)的长度,使得引线(638a,638b,638c,638d,638e,638f)可定位在柄部组件(610)的主体(612)内或甚至相对于该柄部组件的该主体定位在近侧。例如,导航传感器组件(610)可具有大约数米的长度。这样,导航传感器组件(610)既可生成位置相关信号又可将位置相关信号传输到耦接单元,而不需要在该耦接单元之间布线电线或电缆。In some versions, the length of the navigation sensor assembly (610) defined between the proximal and distal ends (640, 641) of the base plate (626) may be large enough to position the distal navigation sensors (652, 653, 656, 657) on the outer axis (616) at or near the lateral axis window (621) to facilitate navigation of the lateral axis window (621) while also positioning the leads (638a, 638b, 638c, 638d, 638e, 638f) sufficiently proximally at which the leads (638a, 638b, 638c, 638d, 638e, 638f) can be electrically coupled directly to the coupling unit (eg, without the need to insert wires or cables). In this regard, the length of the navigation sensor assembly (610) can be substantially equal to or greater than the length of the shaft assembly (604) such that the leads (638a, 638b, 638c, 638d, 638e, 638f) can be positioned on the handle assembly (638a, 638b, 638c, 638f) 610) within or even proximally positioned relative to the body (612) of the handle assembly. For example, navigation sensor assembly (610) may be on the order of several meters in length. In this way, the navigation sensor assembly (610) can both generate and transmit position-related signals to the coupling unit without the need to run wires or cables between the coupling units.

虽然本示例的导航传感器组件(610)沿外轴(616)的大致柱形外表面设置,但是导航传感器组件(610)可另选地以大致弯曲构型沿外轴(616)的大致柱形内表面设置,在该大致弯曲构型中,导航传感器组件(610)围绕外轴(616)的纵向轴线以对应于外轴(616)的柱形内表面的曲率半径的曲率半径弯曲,以由此适形于外轴(616)的内圆周。在任何情况下,导航传感器组件(610)可准许用于内腔沿如上文所述的外轴(616)延伸的空间,使得导航传感器组件(610)可在组织的切断和/或抽吸期间将位置相关信号连续地传送到处理器(52)。换句话说,组织的切断/抽吸和外轴(616)的导航可同时进行,而不会彼此干扰。While the navigation sensor assembly (610) of this example is disposed along the generally cylindrical outer surface of the outer shaft (616), the navigation sensor assembly (610) may alternatively be in a generally curved configuration along the generally cylindrical shape of the outer shaft (616). The inner surface is configured in the generally curved configuration in which the navigation sensor assembly (610) is curved about the longitudinal axis of the outer shaft (616) with a radius of curvature corresponding to the radius of curvature of the cylindrical inner surface of the outer shaft (616) to be formed by This conforms to the inner circumference of the outer shaft (616). In any event, the navigation sensor assembly (610) may permit space for the lumen to extend along the outer axis (616) as described above, such that the navigation sensor assembly (610) may be used during dissection and/or aspiration of tissue. Position-related signals are continuously communicated to the processor (52). In other words, tissue severing/aspiration and navigation of the outer shaft (616) can occur simultaneously without interfering with each other.

虽然未示出,但是导航传感器组件(610)可包括形成(例如,印刷和/或嵌入)在基板(626)上的至少一个温度传感器,以用于检测基板(626)和/或在至少一个导航传感器(650,652,653,654,656,657)处或附近的周围环境的温度,并且生成指示检测到的温度的信号,该信号可由处理器(52)处理,以用于以与上文所述的方式类似的方式提高由处理器(52)根据导航传感器(650,652,653,654,656,657)的位置相关信号计算的位置坐标的准确性。就这一点而言,应当了解,机动驱动组件相对于外轴(616)可旋转地驱动切割构件(618)的操作可导致轴组件(604)的温度升高,这又可导致导航传感器(650,652,653,654,656,657)中的温度变化引起的电阻变化。在其他型式中,导航传感器(650,652,653,654,656,657)的温度变化可通过检测相应同心环部分(630b,632b,633b,634b,636b,637b)的阻抗变化来确定。在任何情况下,处理器(52)可基于温度数据来调整位置坐标的计算以校正由温度变化引起的任何电阻变化。Although not shown, the navigation sensor assembly (610) may include at least one temperature sensor formed (eg, printed and/or embedded) on the substrate (626) for sensing the substrate (626) and/or at least one Navigate the temperature of the surrounding environment at or near the sensor (650, 652, 653, 654, 656, 657) and generate a signal indicative of the detected temperature, which signal may be processed by the processor (52) for use in a manner similar to that described above. Accuracy of position coordinates calculated by the processor (52) based on position-related signals from the navigation sensor (650, 652, 653, 654, 656, 657). In this regard, it should be understood that operation of the motorized drive assembly to rotatably drive the cutting member (618) relative to the outer shaft (616) can cause an increase in the temperature of the shaft assembly (604), which in turn can cause the navigation sensor (650,652,653,654,656,657 ) changes in resistance caused by temperature changes. In other versions, temperature changes of the navigation sensors (650, 652, 653, 654, 656, 657) may be determined by detecting changes in impedance of corresponding concentric ring portions (630b, 632b, 633b, 634b, 636b, 637b). In any case, the processor (52) may adjust the calculation of the position coordinates based on the temperature data to correct for any resistance changes caused by temperature changes.

F.带有弯曲柔性导航传感器组件的示例性剃刮器械F. Exemplary Shaving Instrument with Curved Flexible Navigation Sensor Assembly

图38示出了可用于从解剖通道切断并移除组织(诸如骨组织)的器械(700)的另一示例。例如,器械(700)可用于从鼻腔以及从任何其他合适位置切断和移除骨组织。该示例的器械(700)包括柄部组件(未示出)、毂(703)、轴组件(704)和导航传感器组件(610),并且可类似于器械(600),除非另外描述。器械(700)可与抽吸源(未示出)耦接,该抽吸源能够操作以在手术部位处选择性地提供足够的抽吸,以将切断的组织朝近侧拉动通过器械(700)。Figure 38 shows another example of an instrument (700) that can be used to sever and remove tissue, such as bone tissue, from an anatomical passage. For example, instrument (700) may be used to sever and remove bone tissue from the nasal cavity, as well as from any other suitable location. Instrument (700) of this example includes a handle assembly (not shown), hub (703), shaft assembly (704), and navigation sensor assembly (610), and may be similar to instrument (600) unless otherwise described. Instrument (700) may be coupled with a suction source (not shown) operable to selectively provide sufficient suction at the surgical site to draw severed tissue proximally through instrument (700) ).

轴组件(704)通常包括共同被构造成接纳和移除来自外科手术部位的组织的纵向弯曲的刚性外轴(716)和内切割构件(未示出)。在一些型式中,外轴(716)的远侧部分可相对于外轴(716)的近侧部分以大约60°的角度取向。在任何情况下,外轴(716)包括被构造成与内切割构件的切割窗开口(未示出)协作的侧向轴窗开口(未示出)。Shaft assembly (704) generally includes a longitudinally curved rigid outer shaft (716) and an inner cutting member (not shown) that are jointly configured to receive and remove tissue from a surgical site. In some versions, the distal portion of outer shaft (716) may be oriented at an angle of approximately 60° relative to the proximal portion of outer shaft (716). In any case, the outer shaft (716) includes a lateral shaft window opening (not shown) configured to cooperate with a cutting window opening (not shown) of the inner cutting member.

如图所示,导航传感器组件(610)设置在外轴(716)的外部上并且能够操作以向外轴(716)提供导航能力。更具体地,导航传感器组件(610)以大致弯曲构型沿外轴(716)的大致柱形外表面设置,在该大致弯曲构型中,导航传感器组件(610)围绕外轴(716)的纵向轴线以对应于外轴(716)的柱形外表面的曲率半径的曲率半径弯曲,以由此适形于外轴(716)的外圆周。导航传感器组件(610)也纵向弯曲以适形于外轴(716)的纵向弯曲。As shown, a navigation sensor assembly (610) is disposed on the exterior of the outer shaft (716) and is operable to provide navigation capabilities to the outer shaft (716). More specifically, the navigation sensor assembly (610) is disposed along the generally cylindrical outer surface of the outer shaft (716) in a generally curved configuration in which the navigation sensor assembly (610) surrounds the outer shaft (716). The longitudinal axis is curved with a radius of curvature corresponding to the radius of curvature of the cylindrical outer surface of the outer shaft (716) to thereby conform to the outer circumference of the outer shaft (716). The navigation sensor assembly (610) also bends longitudinally to conform to the longitudinal bending of the outer shaft (716).

III.示例性导航适配器护套III. Exemplary Navigation Adapter Sheath

如上所述,可能期望提供一种带有柔性电路的器械,该柔性电路具有集成导航传感器。还可能期望提供一种带有柔性电路的适配器,该柔性电路具有一个或多个集成导航传感器,其中此类适配器可容易地与另外缺少任何导航传感器的器械耦接。在此类场景下,适配器可向器械赋予导航能力。类似地,可能期望将带有柔性电路的适配器与已经具有一个或多个导航传感器的器械结合使用,该柔性电路具有一个或多个集成导航传感器,其中来自适配器的一个或多个导航传感器的位置数据可补充来自器械的一个或多个导航传感器的位置数据。在此类场景下,适配器可增强器械的导航能力。在上述两种场景中的任一种场景中,适配器可被构造成避免增加器械的体积;并且容易地与外科领域中的器械组装在一起。As mentioned above, it may be desirable to provide an instrument with a flexible circuit having integrated navigation sensors. It may also be desirable to provide an adapter with a flexible circuit having one or more integrated navigation sensors, where such an adapter can be easily coupled to instruments that otherwise lack any navigation sensors. In such scenarios, the adapter can provide navigation capabilities to the device. Similarly, it may be desirable to use an adapter with a flexible circuit that has one or more integrated navigation sensors in conjunction with an instrument that already has one or more navigation sensors, where the position of the one or more navigation sensors from the adapter The data may be supplemented with position data from one or more navigation sensors of the instrument. In such scenarios, adapters can enhance the instrument's navigation capabilities. In either scenario, the adapter can be configured to avoid adding bulk to the instrument; and to be easily assembled with instruments in the surgical field.

图39至图43以适配器护套(1100)的形式示出了可提供上述益处和功能的适配器的示例。在本示例中,适配器护套(1100)与组织剃刮器械(1000)耦接。该示例的组织剃刮器械(1000)包括主体(1002)、抽吸端口(1004)、旋转控制旋钮(1006)、功率源连接器(1008)、毂(1010)和轴组件(1020)。主体(1002)被构造成由操作者握持。抽吸端口(1004)被配置成与抽吸源耦接,使得可施加抽吸以在组织剃刮器械(1000)的操作期间吸取组织和流体。旋转控制旋钮(1006)能够相对于主体(1002)旋转以围绕轴组件(1020)的纵向轴线重新定向轴组件(1020)。功率源连接器(1008)被配置成与功率源耦接以向主体(1002)中的马达(未示出)提供电力。马达能够操作来以如本领域已知的方式驱动轴组件(1020)的切割轴(未示出)。Figures 39-43 illustrate an example of an adapter in the form of an adapter boot (1100) that can provide the benefits and functionality described above. In this example, adapter sheath (1100) is coupled to tissue shaving instrument (1000). The example tissue shaving instrument (1000) includes a body (1002), a suction port (1004), a rotary control knob (1006), a power source connector (1008), a hub (1010), and a shaft assembly (1020). The main body (1002) is configured to be held by an operator. Suction port (1004) is configured to couple with a suction source such that suction can be applied to aspirate tissue and fluid during operation of tissue shaving instrument (1000). The rotary control knob (1006) is rotatable relative to the body (1002) to reorient the shaft assembly (1020) about its longitudinal axis. Power source connector (1008) is configured to couple with a power source to provide power to a motor (not shown) in body (1002). The motor is operable to drive a cutting shaft (not shown) of shaft assembly (1020) as is known in the art.

除了包括切割轴之外,轴组件(1020)还包括外轴(1030)和端部执行器(1022)。端部执行器(1022)位于轴组件(1020)的远侧端部处。如图43最佳可见,端部执行器(1022)包括形成在外轴(1030)的远侧端部处的横向开口(1040),锯齿状切割边缘(1042)沿开口(1040)的周边延伸。切割轴定位在外轴(1030)内部并且包括与横向开口(1040)和切割边缘(1042)互补的类似的横向开口和切割边缘。主体(1002)中的马达驱动切割轴相对于外轴(1030)围绕轴组件(1020)的纵向轴线旋转。在此类旋转期间,经由由切割轴限定的内腔施加抽吸以将组织吸取到开口(1040)中,切割轴的切割边缘与外轴(1030)的切割边缘(1042)协作以剪切组织,并且剪切的组织在抽吸的影响下朝近侧被吸取通过切割轴的内腔。本领域的普通技术人员应当理解,在组织剃刮器械(1000)的操作期间具有来自导航传感器的指示端部执行器(1022)在患者体内的实时位置的数据可能是有益的。In addition to including the cutting shaft, shaft assembly (1020) also includes an outer shaft (1030) and an end effector (1022). An end effector (1022) is located at the distal end of shaft assembly (1020). As best seen in Figure 43, end effector (1022) includes a transverse opening (1040) formed at the distal end of outer shaft (1030) with a serrated cutting edge (1042) extending along the perimeter of the opening (1040). The cutting shaft is positioned inside the outer shaft (1030) and includes similar transverse openings (1040) and cutting edges (1042) complementary to the transverse openings (1040) and cutting edges (1042). A motor in body (1002) drives the cutting shaft to rotate relative to outer shaft (1030) about the longitudinal axis of shaft assembly (1020). During such rotation, suction is applied through the lumen defined by the cutting shaft to draw tissue into the opening (1040), the cutting edge of the cutting shaft cooperating with the cutting edge (1042) of the outer shaft (1030) to shear tissue , and the sheared tissue is sucked proximally through the lumen of the cutting shaft under the influence of suction. One of ordinary skill in the art will appreciate that it may be beneficial to have data from navigation sensors indicating the real-time position of the end effector (1022) within the patient's body during operation of the tissue shaving instrument (1000).

如图39至图40所示,本示例的适配器护套(1100)包括毂(1110)、从毂(1110)朝远侧延伸的轴组件(1120)、电缆(1102)和连接器(1104)。如图41最佳可见,轴组件(1120)包括中空外轴(1130)、柔性电路(1140)和中空内轴(1150)。毂(1110)固定地固定到外轴(1130)的近侧端部。柔性电路(1140)包括柔性基板(1142)、一对导航传感器(1144,1146)和迹线(未示出)。柔性基板(1142)、导航传感器(1144,1146)和迹线可被配置成可操作的,如上述各种柔性基板、导航传感器和迹线中的任一者。柔性电路(1140)可具有仅一个单层或多个层。As shown in Figures 39-40, the adapter housing (1100) of this example includes a hub (1110), a shaft assembly (1120) extending distally from the hub (1110), a cable (1102), and a connector (1104) . As best seen in Figure 41, shaft assembly (1120) includes a hollow outer shaft (1130), a flex circuit (1140), and a hollow inner shaft (1150). Hub (1110) is fixedly secured to the proximal end of outer shaft (1130). Flexible circuit (1140) includes a flexible substrate (1142), a pair of navigation sensors (1144, 1146) and traces (not shown). The flexible substrate (1142), navigation sensors (1144, 1146), and traces may be configured to be operable, such as any of the various flexible substrates, navigation sensors, and traces described above. Flexible circuit (1140) may have only a single layer or multiple layers.

如图42所示,轴组件(1120)被构造成使得内轴(1150)同轴地嵌套在外轴(1130)内,柔性电路(1140)径向地插置在内轴(1150)的外部与外轴(1130)的内部之间。在一些型式中,轴组件(1120)被构造成使得柔性电路(1140)嵌入在内轴(1150)和/或外轴(1130)内或以其他方式与内轴和/或外轴耦接。在一些型式中,外轴(1130)的远侧端部(1132)焊接到到内轴(1150)的远侧端部(1152)或以其他方式固定到内轴的远侧端部。另外或另选地,轴(1130,1150)的近侧部分可焊接在一起或以其他方式固定在一起。轴(1130,1150)与柔性电路(1140)之间的关系可为柔性电路(1140)提供保护,使得轴组件(1120)可经受不同种类的消毒规程,否则如果柔性电路(1140)的一个或多个特征部暴露,则这些消毒规程可能损坏这些特征部。虽然在该示例中柔性电路(1140)插置在轴(1130,1150)之间,但是柔性电路(1140)可插置在任何其他合适种类的管状构件之间,或以其他方式相对于任何其他合适种类的管状构件定位。As shown in Figure 42, the shaft assembly (1120) is configured such that the inner shaft (1150) is coaxially nested within the outer shaft (1130) and the flex circuit (1140) is radially interposed externally of the inner shaft (1150). and the inside of the outer shaft (1130). In some versions, shaft assembly (1120) is configured such that flex circuit (1140) is embedded within or otherwise coupled to inner shaft (1150) and/or outer shaft (1130). In some versions, the distal end (1132) of the outer shaft (1130) is welded to or otherwise secured to the distal end (1152) of the inner shaft (1150). Additionally or alternatively, the proximal portions of the shafts (1130, 1150) may be welded or otherwise secured together. The relationship between the shafts (1130, 1150) and the flexible circuit (1140) can provide protection for the flexible circuit (1140) such that the shaft assembly (1120) can withstand different types of sterilization procedures, otherwise if one or more of the flexible circuits (1140) If multiple features are exposed, these disinfection procedures may damage the features. Although in this example the flexible circuit (1140) is interposed between the shafts (1130, 1150), the flexible circuit (1140) may be interposed between any other suitable kind of tubular members, or otherwise relative to any other Positioning of tubular members of the appropriate kind.

内轴(1150)限定与组织剃刮器械(1000)的外轴(1030)的外径对应的内径(ID),使得轴组件(1020)可容易地插入轴组件(1120)中,轴组件(1120)紧密地对应于轴组件(1020)。在此类紧密对应的情况下,轴组件(1120)可能不会实质上增加轴组件(1020)的外径,使得适配器护套(1100)的添加可能不会不期望地增大组织剃刮器械(1000)的轮廓。换句话说,适配器护套(1100)的存在可能不会不期望地干扰组织剃刮器械(1000)的正常使用。The inner shaft (1150) defines an inner diameter (ID) that corresponds to the outer diameter of the outer shaft (1030) of the tissue shaving instrument (1000) such that the shaft assembly (1020) can be easily inserted into the shaft assembly (1120). 1120) corresponds closely to shaft assembly (1020). With such close correspondence, shaft assembly (1120) may not substantially increase the outer diameter of shaft assembly (1020) such that the addition of adapter sheath (1100) may not undesirably enlarge the tissue shaving instrument (1000) outline. In other words, the presence of adapter sheath (1100) may not undesirably interfere with normal use of tissue shaving instrument (1000).

适配器护套(1100)的毂(1110)被构造成与组织剃刮器械(1000)的毂(1010)接合,以由此相对于组织剃刮器械(1000)可移除地固定适配器护套(1100)。仅以举例的方式,毂(1110)可提供与毂(1010)的卡扣配合、过盈配合或任何其他合适种类的关系。如图39和图43所示,轴组件(1120)的长度使得当适配器护套(1100)完全就座在组织剃刮器械(1000)上时,远侧端部(1132,1152)恰好位于端部执行器(1022)的近侧。还如图43所示,其中省略了外轴(1130),适配器护套(1100)的远侧导航传感器(1146)定位成与端部执行器(1022)相邻。远侧导航传感器(1146)的此类位置可因此允许远侧导航传感器(1146)容易地指示端部执行器(1022)的实时位置。适配器护套(1100)的近侧导航传感器(1146)定位在距端部执行器(1022)的更近侧,使得近侧导航传感器(1146)可容易地指示轴组件(1020)的对应近侧部分的实时位置。在一些型式中,省略了近侧导航传感器(1146)。The hub (1110) of the adapter sheath (1100) is configured to engage the hub (1010) of the tissue shaving instrument (1000) to thereby removably secure the adapter sheath (1110) relative to the tissue shaving instrument (1000). 1100). By way of example only, hub (1110) may provide a snap fit, interference fit, or any other suitable kind of relationship with hub (1010). As shown in Figures 39 and 43, the length of the shaft assembly (1120) is such that when the adapter sheath (1100) is fully seated on the tissue shaving instrument (1000), the distal ends (1132, 1152) are just near side of the actuator (1022). As also shown in Figure 43, where the outer shaft (1130) is omitted, the distal navigation sensor (1146) of the adapter sheath (1100) is positioned adjacent the end effector (1022). Such position of the distal navigation sensor (1146) may thus allow the distal navigation sensor (1146) to readily indicate the real-time position of the end effector (1022). The proximal navigation sensor (1146) of the adapter sheath (1100) is positioned more proximally from the end effector (1022) such that the proximal navigation sensor (1146) can readily indicate the corresponding proximal side of the shaft assembly (1020) Part of the real-time location. In some versions, the nearside navigation sensor (1146) is omitted.

虽然在该示例中在柔性电路(1140)的远侧端部处示出仅一个导航传感器(1144),但是一些变型可在柔性电路(1140)的远侧端部处提供两个或更多个导航传感器(1144)。类似地,虽然在位于导航传感器(1144)近侧的柔性电路(1140)上示出了仅一个导航传感器(1146),但是可在导航传感器(1144)近侧设置两个或更多个导航传感器(1146)。Although only one navigation sensor (1144) is shown at the distal end of flexible circuit (1140) in this example, some variations may provide two or more at the distal end of flexible circuit (1140) Navigation sensors (1144). Similarly, although only one navigation sensor (1146) is shown on the flex circuit (1140) proximal to the navigation sensor (1144), two or more navigation sensors may be provided proximal to the navigation sensor (1144). (1146).

柔性电路(1140)的迹线被配置成将位置指示信号从导航传感器(1144,1146)传送到电缆(1102)。电缆(1102)被配置成将这些位置指示信号传送到连接器(1104)。连接器(1104)被配置成与IGS导航系统(50)耦接,并且由此将位置指示信号传送到IGS导航系统(50)。在一些型式中,连接器(1104)被配置成插入IGS导航系统(50)的对应插座中。在一些其他型式中,连接器(1104)包括无线发射器,该无线发射器能够操作以将位置指示信号无线地发射到IGS导航系统(50)。在仍其他型式中,省略了电缆(1102)和连接器(1104),并且适配器护套(1100)的一些其他部件被配置成将位置指示信号无线地发射到IGS导航系统(50)。仅以举例的方式,一个或多个无线发射器可被集成到毂(1110)中。另选地,位置指示信号可以任何其他合适的方式传送到IGS导航系统(50)。Traces of the flex circuit (1140) are configured to carry position indicating signals from the navigation sensors (1144, 1146) to the cable (1102). Cable (1102) is configured to carry these position indicating signals to connector (1104). Connector (1104) is configured to couple with IGS navigation system (50) and thereby transmit a position indicating signal to IGS navigation system (50). In some versions, connector (1104) is configured to plug into a corresponding receptacle on IGS navigation system (50). In some other versions, the connector (1104) includes a wireless transmitter operable to wirelessly transmit a position indicating signal to the IGS navigation system (50). In still other versions, cable (1102) and connector (1104) are omitted, and some other component of adapter housing (1100) is configured to wirelessly transmit a position indicating signal to the IGS navigation system (50). By way of example only, one or more wireless transmitters may be integrated into hub (1110). Alternatively, the position indication signal may be transmitted to the IGS navigation system (50) in any other suitable manner.

在一些型式中,外轴(1130)和内轴(1150)各自包含金属材料。在一些其他型式中,外轴(1130)和内轴(1150)各自包含聚合物材料。在一些其他型式中,外轴(1130)包含金属材料,而内轴(1150)包含聚合物材料。在一些其他型式中,外轴(1130)包含聚合物材料,而内轴(1150)包含金属材料。不管用于形成轴(1130,1150)的一种或多种材料,轴(1130,1150)中的一者或两者可以是刚性的、可延展的、柔性的、和/或具有任何其他合适的特性。因此,虽然轴(1130,1150)在本示例中被示出为是直的,但是轴(1130,1150)另选地可以是弯曲的或具有任何其他种类的非直线构型。在其中轴(1130,1150)是弯曲的或具有任何其他种类的非直线构型的型式中,轴(1130,1150)可以此类方式刚性地构造;或者在轴(1130、1150)是可延展的或柔性的情况下可由操作者弯曲以实现这种构型。In some versions, outer shaft (1130) and inner shaft (1150) each comprise metallic material. In some other versions, outer shaft (1130) and inner shaft (1150) each comprise a polymer material. In some other versions, the outer shaft (1130) includes a metallic material and the inner shaft (1150) includes a polymeric material. In some other versions, the outer shaft (1130) includes a polymeric material and the inner shaft (1150) includes a metallic material. Regardless of the material or materials used to form shafts (1130, 1150), one or both of shafts (1130, 1150) may be rigid, malleable, flexible, and/or have any other suitable characteristics. Thus, while the axes (1130, 1150) are shown as straight in this example, the axes (1130, 1150) may alternatively be curved or have any other kind of non-linear configuration. In versions where the shafts (1130, 1150) are curved or have any other kind of non-linear configuration, the shafts (1130, 1150) may be rigidly constructed in such a manner; or in versions where the shafts (1130, 1150) are malleable or flexible case that can be bent by the operator to achieve this configuration.

虽然适配器护套(1100)在组织剃刮器械(1000)的情况下被示出和描述,但是适配器护套(1100)可容易地与任何其他合适种类的器械一起使用。适配器护套(1100)不必限于组织剃刮器械(如组织剃刮器械(1000))的情况。仅以举例的方式,适配器护套(1100)可被设置成适配在内窥镜、不同种类的ENT器械和/或参考本文的教导内容对本领域的技术人员而言将显而易见的任何其他种类的器械上方。适配器护套(1100)的长度可基于将与适配器护套(1100)耦接的器械的种类而变化。不管与适配器护套(1100)耦接的器械的种类如何,适配器护套(1100)可在器械将与适配器护套(1100)一起使用的医疗规程之前容易地与器械耦接。在医疗规程完成之后,适配器护套(1100)可从器械移除。移除的适配器护套(1100)可被丢弃或消毒以供随后再次使用。Although adapter sheath (1100) is shown and described in the context of a tissue shaving instrument (1000), adapter sheath (1100) may readily be used with any other suitable kind of instrument. Adapter sheath (1100) need not be limited to tissue shaving instruments such as tissue shaving instrument (1000). By way of example only, the adapter sheath (1100) may be configured to fit an endoscope, different kinds of ENT instruments, and/or any other kind that will be apparent to one skilled in the art in light of the teachings herein. above the instrument. The length of adapter sheath (1100) may vary based on the type of instrument to which adapter sheath (1100) will be coupled. Regardless of the type of instrument to which adapter sheath (1100) is coupled, adapter sheath (1100) can be easily coupled to the instrument prior to a medical procedure in which the instrument is to be used with adapter sheath (1100). After the medical procedure is completed, the adapter sheath (1100) can be removed from the instrument. The removed adapter sheath (1100) can be discarded or sterilized for subsequent reuse.

IV.用于校准导航传感器的示例性方法IV. Exemplary Methods for Calibrating Navigation Sensors

在一些情况下,可能期望提供用于准确且可靠地校准导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的一种或多种方法,该方法可包括基于导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)与相应器械(100,400,500,600,700,1000)的远侧末端之间的距离来校准每个导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的位置和/或取向。另外或另选地,校准导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)可包括校准每个导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)对由场发生器(64)生成的电磁场的灵敏度。In some cases, it may be desirable to provide one or more methods for accurately and reliably calibrating navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) that may include based on navigation sensors (150,152,1 54,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and corresponding devices ( 100,400,500,600,700,1000) to calibrate the distance between the far side ends of each navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) location and/or orientation. Additionally or alternatively, calibrating the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) may include calibrating each navigation sensor (150,152,154,156,250,252 ,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) sensitivity to the electromagnetic field generated by the field generator (64).

导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的校准可至少部分地直接集成到相应导航传感器组件(110,210,410,510,610,1100)的制造中并且/或者将相应导航传感器组件(110,210,410,510,610,1100)应用到对应器械(100,400,500,600,700)上。例如,一旦确定导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的灵敏度,便可使用可重复制造技术来准确且可靠地重新创建具有相同灵敏度的相同导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)。例如,通过在对应基板(126,226,426,526,626,1142)上印刷相应迹线(130,132,134,136,230,232,234,236,630,632,633,634,636,637)来将导航传感器组件(110,210,410,510,610,1144,1146)形成为柔性印刷电路板(PCB)可有助于确保可准确且可靠地重新创建具有相同灵敏度的相同导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)。类似地,一旦确定导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)与相应器械(100,400,500,600,700,1000)的远侧末端之间的距离,便可使用可重复应用技术来将相同导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)准确且可靠地定位在距相应的相同器械(100,400,500,600,700,1000)的远侧末端相同的距离处。例如,对应的导航传感器组件(110,210,410,510,610,1100)的通孔(146,246,646)和/或斜面(148,248,648)可有助于确保相同导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)准确且可靠地定位在距相应的相同器械(100,400,500,600,700,1000)的远侧末端预定距离处。The calibration of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) can be at least partially directly integrated into the corresponding navigation sensor assembly (110,210,410,510,610,11 00) and/or applying the corresponding navigation sensor assembly (110, 210, 410, 510, 610, 1100) to the corresponding device (100, 400, 500, 600, 700) superior. For example, once the sensitivity of a navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) is determined, repeatable manufacturing techniques can be used to accurately and reliably recreate the same navigation sensor (150,152, 154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146). For example, the navigation sensor assembly (110,210,410,510,610,1 144,1146) formed into flexible printed circuit boards (PCBs) can help ensure that accurate and reliable Recreate the same navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) with the same sensitivity. Similarly, once the distance between the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and the corresponding instrument (100,400,500,600,700,1000) is determined The same navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) Accurately and reliably positioned at the same distance from the distal tip of the corresponding identical instrument (100, 400, 500, 600, 700, 1000). For example, through holes (146,246,646) and/or bevels (148,248,648) of corresponding navigation sensor assemblies (110,210,410,510,610,1100) may help ensure that the same navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553, 650,652,653,654,656,657,1144,1146) accurately and reliably positioned at the same distance from the corresponding at a predetermined distance from the distal tip of the instrument (100, 400, 500, 600, 700, 1000).

图44和图45示出了可用于确定导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)与相应器械(100,400,500,600,700,1000)的远侧末端之间的距离的光学校准方法(801)的示例。参考图44,方法(801)开始于步骤(803),在该步骤处,具有应用到其上的至少一个导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的器械(100,400,500,600,700)定位在光学测量装置内。方法(801)从步骤(803)前进至步骤(805),在该步骤处,光学测量装置测量导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的中心点或其他基准特征部与器械(100,400,500,600,700,1000)的远侧末端之间的距离。方法(801)从步骤(805)前进至步骤(807),在该步骤处,光学测量装置将测量的距离传送到处理器。方法(801)从步骤(807)前进至步骤(809),在该步骤处,光学测量装置测量导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的几何形态。方法(801)从步骤(809)前进至步骤(811),在该步骤处,光学测量装置将测量的几何形态传送到处理器。应当了解,导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的几何形态可与其灵敏度直接相关,使得处理器在一些型式中可基于测量的几何形态来确定导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的灵敏度。在一些型式中,步骤(809,811)中的一者或多者可在步骤(805,807)中的一个或多个之前执行和/或与其同时执行。在任何情况下,方法(801)前进至步骤(813),在该步骤处,处理器将校准数据(例如,测量的距离、测量的几何形态和/或确定的灵敏度)存储在存储器装置(例如,EPROM)上,该存储器装置可操作地耦接到器械(100,400,500,600,700,1000)以便于校准数据的后续检索。Figures 44 and 45 show that the navigation sensors (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) and the corresponding instruments (100,400,500,600,700,1 Example of optical calibration method (801) for distance between distal tips of 000). Referring to Figure 44, the method (801) begins with step (803) at which an instrument (803) having at least one navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) applied thereto 100, 400, 500, 600, 700) positioned within the optical measurement device. The method (801) proceeds from step (803) to step (805) where the optical measurement device measures the center point or other of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) Reference features and instruments (100, 400, 500, 600, 700, 1000) The distance between the distal ends. The method (801) proceeds from step (805) to step (807) where the optical measurement device communicates the measured distance to the processor. Method (801) proceeds from step (807) to step (809) where the optical measurement device measures the geometry of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146). The method (801) proceeds from step (809) to step (811) where the optical measurement device communicates the measured geometry to the processor. It will be appreciated that the geometry of the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) can be directly related to its sensitivity, allowing the processor in some versions to determine the navigation sensor (150,15 2,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146) sensitivity. In some versions, one or more of steps (809, 811) may be performed before and/or concurrently with one or more of steps (805, 807). In any case, method (801) proceeds to step (813) where the processor stores calibration data (eg, measured distance, measured geometry, and/or determined sensitivity) in a memory device (eg, , EPROM), the memory device is operatively coupled to the instrument (100, 400, 500, 600, 700, 1000) to facilitate subsequent retrieval of calibration data.

参考图45,示出了使用方法(801)的导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的示例性几何测量的照片。几何测量可包括测量形成导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的相应迹线(130,132,134,136,230,232,234,236,630,632,633,634,636,637)的每一片段的厚度,以及/或者测量形成导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)的相应迹线(130,132,134,136,230,232,234,236,630,632,633,634,636,637)的相邻片段之间的距离。Referring to Figure 45, photographs of exemplary geometric measurements of navigation sensors (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146) using method (801) are shown. Geometric measurements may include measuring corresponding traces (130,132,134,136,230,232,2 34,236,630,632,633,634,636,637) and/or measure the thickness of each segment forming the navigation sensor (150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1 146) corresponding traces (130,132,134,136,230,232,234,236,630,632,633,634,636,637) the distance between adjacent segments.

V.带有消融电极的示例性柔性电路V. Exemplary Flexible Circuit with Ablation Electrodes

在一些场景下,可能期望向诸如组织剃刮器械的器械提供RF消融或烧灼功能。此类RF消融或烧灼可用于阻止组织出血,提供其他治疗效果,以及/或者提供其他种类的组织效果。可进一步期望利用柔性电路技术来向器械提供此类RF消融或烧灼功能。此类柔性电路技术的使用可便于器械的制造。例如,器械可另外根据先前实践制造,其中器械将缺乏RF消融或烧灼功能,并且柔性电路可容易地应用于另外的常规器械的轴组件。另外或另选地,柔性电路可对RF消融或烧灼功能提供结构上坚固的支撑,并且允许器械的轴组件维持小轮廓,尽管添加了RF消融或烧灼功能。下面将更详细地描述如何将柔性电路组件集成到组织剃刮器械中以赋予RF消融或烧灼功能的若干示例。在本公开的上下文中,术语“消融”和“烧灼”应当可互换地理解,使得单独提及消融不应当被理解为排除烧灼;并且单独提及烧灼不应当被理解为排除消融。In some scenarios, it may be desirable to provide RF ablation or cauterization functionality to an instrument, such as a tissue shaving instrument. Such RF ablation or cauterization can be used to stop tissue bleeding, provide other therapeutic effects, and/or provide other kinds of tissue effects. It may further be desirable to utilize flexible circuit technology to provide such RF ablation or cauterization functionality to devices. The use of such flexible circuit technology can facilitate device manufacturing. For example, the device could otherwise be manufactured according to prior practice, where the device would lack RF ablation or cautery functionality, and the flex circuit could be readily applied to the shaft assembly of an otherwise conventional device. Additionally or alternatively, the flexible circuit may provide structurally robust support for the RF ablation or cauterization functionality and allow the instrument's shaft assembly to maintain a small profile despite the addition of the RF ablation or cautery functionality. Several examples of how flexible circuit assemblies can be integrated into tissue shaving instruments to impart RF ablation or cauterization functionality are described in more detail below. In the context of this disclosure, the terms "ablation" and "cauterization" should be understood interchangeably, such that reference to ablation alone should not be understood to exclude cauterization; and reference to cautery alone should not be understood to exclude ablation.

图46示出了用于剃刀器械的轴组件(1200)的示例,该轴组件结合有消融柔性电路(1230)。在图46中仅示出了剃刀器械的轴组件(1200)。轴组件(1200)包括外轴(1202)和内切割轴(1220)。轴组件(1200)限定端部执行器(1210),该端部执行器由形成在外轴(1202)的远侧端部(1204)处的横向开口(1206)形成,锯齿状切割边缘(1208)沿开口(1206)的周边延伸。切割轴(1220)定位在外轴(1202)内部并且包括与横向开口(1206)和切割边缘(1208)互补的类似的横向开口和切割边缘(1222)。马达(未示出)能够操作以驱动内切割轴(1220)相对于外轴(1202)围绕由轴组件(1200)限定的纵向轴线旋转。抽吸源(未示出)能够操作以对通过切割轴(1220)形成的内腔施加抽吸,以由此将组织吸取到横向开口(1206)中。当切割轴(1220)相对于外轴(1202)旋转时,切割边缘(1208,1222)协作以剪切组织,并且剪切的组织在抽吸的影响下朝近侧被吸取通过切割轴的内腔。Figure 46 shows an example of a shaft assembly (1200) for a razor instrument incorporating an ablation flex circuit (1230). Only the shaft assembly (1200) of the razor instrument is shown in Figure 46. Shaft assembly (1200) includes an outer shaft (1202) and an inner cutting shaft (1220). Shaft assembly (1200) defines an end effector (1210) formed by a lateral opening (1206) formed at a distal end (1204) of outer shaft (1202), a serrated cutting edge (1208) Extends along the perimeter of opening (1206). Cutting shaft (1220) is positioned within outer shaft (1202) and includes similar lateral openings and cutting edges (1222) complementary to lateral openings (1206) and cutting edges (1208). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1220) relative to the outer shaft (1202) about a longitudinal axis defined by the shaft assembly (1200). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1220) to thereby draw tissue into the lateral opening (1206). As the cutting shaft (1220) rotates relative to the outer shaft (1202), the cutting edges (1208, 1222) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

本示例的柔性电路(1230)包括柔性基板(1232)和多个电极(1234)。柔性电路(1230)可具有仅一个单层或多个层。柔性基板(1232)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或LCP。本示例的柔性基板(1232)沿轴组件(1200)的长度纵向地延伸并且至少部分地围绕外轴(1202)的远侧端部(1204)包裹。在一些型式中,柔性基板(1232)经由粘合剂固定到外轴(1202)的外表面。另选地,柔性基板(1232)可以任何其他合适的方式固定到外轴(1202)。The flexible circuit (1230) of this example includes a flexible substrate (1232) and a plurality of electrodes (1234). Flexible circuit (1230) may have only a single layer or multiple layers. The flexible substrate (1232) may be formed from an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1232) of this example extends longitudinally along the length of the shaft assembly (1200) and wraps at least partially around the distal end (1204) of the outer shaft (1202). In some versions, flexible substrate (1232) is secured to the outer surface of outer shaft (1202) via adhesive. Alternatively, flexible substrate (1232) may be secured to outer shaft (1202) in any other suitable manner.

电极(1234)沿柔性基板(1232)的至少部分地围绕外轴(1202)的远侧端部(1204)包裹的区定位,使得电极(1234)定位在外轴(1202)的远侧端部(1204)处。电极(1234)可气相沉积在基板(1232)上或者可以任何其他合适的方式施加到基板(1232)。柔性基板(1232)提供电极(1234)与外轴(1202)之间的电绝缘,使得柔性基板(1232)防止电极(1234)给外轴(1202)通电。电极(1234)经由沿柔性基板(1232)形成的迹线(未示出)与RF发生器(例如,类似于上述RF发生器(101))耦接。在一些型式中,电极(1234)能够操作以将双极RF能量施加到与电极(1234)接触的组织。在一些其他型式中,电极(1234)能够操作以将单极RF能量施加到与电极(1234)接触的组织。在此类型式中,接地垫(未示出)可在任何合适位置接触患者。不管使用双极RF能量还是单极RF能量,RF能量可在组织剃刮操作期间消融组织。可在切割轴(1220)剃刮组织的同时和/或之后施加此类RF能量,使得RF能量可阻止原本由组织剃刮操作引起的出血。为此,将电极(1234)定位在外轴(1202)的远侧端部(1204)处可能是有利的,因为该位置将靠近组织剃刮部位。The electrode (1234) is positioned along a region of the flexible substrate (1232) that at least partially wraps around the distal end (1204) of the outer shaft (1202) such that the electrode (1234) is positioned at the distal end (1202) of the outer shaft (1202). 1204). Electrode (1234) may be vapor deposited on substrate (1232) or may be applied to substrate (1232) in any other suitable manner. Flexible substrate (1232) provides electrical insulation between electrode (1234) and outer shaft (1202) such that flexible substrate (1232) prevents electrode (1234) from energizing outer shaft (1202). Electrode (1234) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1232). In some versions, electrode (1234) is operable to apply bipolar RF energy to tissue in contact with electrode (1234). In some other versions, electrode (1234) is operable to apply monopolar RF energy to tissue in contact with electrode (1234). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1220) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1234) at the distal end (1204) of the outer shaft (1202) since this location will be close to the tissue shaving site.

虽然在图46中未示出,但柔性电路(1230)还可包括一个或多个集成导航传感器。此类导航传感器可如本文所述的其他各种导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)中的任一者来配置和操作。包括一个或多个集成导航传感器的柔性电路(1230)的型式因此可便于确定端部执行器(1210)在患者体内的实时位置。柔性电路(1230)还可包括一个或多个集成温度传感器(例如,热电偶等)。此类温度传感器可感测电极(1234)和/或与电极(1234)相邻的组织的温度。温度数据可用作实时反馈以调整RF向组织的递送(例如,以避免使组织过热)。柔性电路(1230)可包括除了或代替上述特征部的任何其他合适的特征部。作为变型的又一示例,电极(1234)可在不使用柔性电路(1230)的情况下集成到轴组件(1200)中,使得不一定需要柔性基板(1232)来将电极(1234)集成到轴组件(1200)中。Although not shown in Figure 46, the flex circuit (1230) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1230) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1210) within the patient's body. Flexible circuit (1230) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1234) and/or tissue adjacent electrode (1234). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1230) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1234) can be integrated into shaft assembly (1200) without the use of flex circuit (1230) such that a flexible substrate (1232) is not necessarily required to integrate electrode (1234) into the shaft. in component(1200).

图47示出了用于剃刀器械的轴组件(1300)的示例,该轴组件结合有消融柔性电路(1330)。在图47中仅示出了剃刀器械的轴组件(1300)。轴组件(1300)包括外轴(1302)和内切割轴(1320),该内切割轴被驱动以相对于外轴(1302)围绕由轴组件(1300)限定的纵向轴线旋转。轴组件(1300)限定端部执行器(1310),该端部执行器由形成在外轴(1302)的远侧端部(1304)处的横向开口(1306)形成,锯齿状切割边缘(1308)沿开口(1306)的周边延伸。切割轴(1320)定位在外轴(1302)内部并且包括与横向开口(1306)和切割边缘(1308)互补的类似的横向开口和切割边缘(1322)。马达(未示出)能够操作以驱动内切割轴(1320)相对于外轴(1302)围绕由轴组件(1300)限定的纵向轴线旋转。抽吸源(未示出)能够操作以对通过切割轴(1320)形成的内腔施加抽吸,以由此将组织吸取到横向开口(1306)中。当切割轴(1320)相对于外轴(1302)旋转时,切割边缘(1308,1322)协作以剪切组织,并且剪切的组织在抽吸的影响下朝近侧被吸取通过切割轴的内腔。Figure 47 shows an example of a shaft assembly (1300) for a razor instrument incorporating an ablation flex circuit (1330). Only the shaft assembly (1300) of the razor instrument is shown in Figure 47. Shaft assembly (1300) includes an outer shaft (1302) and an inner cutting shaft (1320) driven for rotation relative to outer shaft (1302) about a longitudinal axis defined by shaft assembly (1300). Shaft assembly (1300) defines an end effector (1310) formed by a lateral opening (1306) formed at a distal end (1304) of outer shaft (1302), a serrated cutting edge (1308) Extends along the perimeter of opening (1306). Cutting shaft (1320) is positioned within outer shaft (1302) and includes similar lateral openings and cutting edges (1322) complementary to lateral openings (1306) and cutting edges (1308). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1320) relative to the outer shaft (1302) about a longitudinal axis defined by the shaft assembly (1300). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1320) to thereby draw tissue into the lateral opening (1306). As the cutting shaft (1320) rotates relative to the outer shaft (1302), the cutting edges (1308, 1322) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

本示例的柔性电路(1330)包括柔性基板(1332)和多个电极(1334)。柔性电路(1330)可具有仅一个单层或多个层。柔性基板(1332)可由电绝缘柔性塑料材料形成,诸如聚酰亚胺或LCP。本示例的柔性基板(1332)沿轴组件(1300)的长度纵向地延伸,朝远侧终止于外轴(1302)的远侧端部(1304)处。在一些型式中,柔性基板(1332)经由粘合剂固定到外轴(1302)的外表面。另选地,柔性基板(1332)可以任何其他合适的方式固定到外轴(1302)。虽然柔性基板(1332)被示出为仅沿外轴(1302)的一侧延伸,但是另一柔性基板(1332)可沿外轴(1302)的另一侧延伸。另外,一些型式的柔性基板(1332)可围绕外轴(1302)的远侧端部(1304)包裹。The flexible circuit (1330) of this example includes a flexible substrate (1332) and a plurality of electrodes (1334). Flexible circuit (1330) may have only a single layer or multiple layers. The flexible substrate (1332) may be formed from an electrically insulating flexible plastic material, such as polyimide or LCP. The flexible substrate (1332) of this example extends longitudinally along the length of the shaft assembly (1300), terminating distally at the distal end (1304) of the outer shaft (1302). In some versions, flexible substrate (1332) is secured to the outer surface of outer shaft (1302) via adhesive. Alternatively, flexible substrate (1332) may be secured to outer shaft (1302) in any other suitable manner. Although flexible substrate (1332) is shown extending along only one side of outer shaft (1302), another flexible substrate (1332) may extend along the other side of outer shaft (1302). Additionally, some form of flexible substrate (1332) may be wrapped around the distal end (1304) of outer shaft (1302).

电极(1334)沿柔性基板(1332)的在外轴(1302)的横向开口(1306)的纵向延伸区旁边延伸的区定位,使得电极(1334)在横向开口(1306)旁边定位。虽然电极(1334)被示出为定位在横向开口(1306)的仅一个纵向延伸区旁边,但是一些型式也可在横向开口(1306)的另一纵向延伸区旁边提供电极(1334)。另外或另选地,除了在横向开口(1306)的纵向延伸区中的任一者或两者旁边提供电极(1334)之外,一些型式还可沿远侧端部(1304)提供电极(1334)(例如,类似于电极(1234))。The electrode (1334) is positioned along an area of the flexible substrate (1332) extending beside the longitudinal extension of the lateral opening (1306) of the outer axis (1302) such that the electrode (1334) is positioned beside the lateral opening (1306). Although electrode (1334) is shown positioned adjacent only one longitudinal extension of transverse opening (1306), some versions may also provide electrode (1334) adjacent another longitudinal extension of transverse opening (1306). Additionally or alternatively, in addition to providing electrodes (1334) adjacent either or both of the longitudinal extensions of the transverse opening (1306), some versions may also provide electrodes (1334) along the distal end (1304) ) (eg, similar to electrode (1234)).

电极(1334)可气相沉积在基板(1332)上或者可以任何其他合适的方式施加到基板(1332)。柔性基板(1332)提供电极(1334)与外轴(1302)之间的电绝缘,使得柔性基板(1332)防止电极(1334)给外轴(1302)通电。电极(1334)经由沿柔性基板(1332)形成的迹线(未示出)与RF发生器(例如,类似于上述RF发生器(101))耦接。在一些型式中,电极(1334)能够操作以将双极RF能量施加到与电极(1334)接触的组织。在一些其他型式中,电极(1334)能够操作以将单极RF能量施加到与电极(1334)接触的组织。在此类型式中,接地垫(未示出)可在任何合适位置接触患者。不管使用双极RF能量还是单极RF能量,RF能量可在组织剃刮操作期间消融组织。可在切割轴(1320)剃刮组织的同时和/或之后施加此类RF能量,使得RF能量可阻止原本由组织剃刮操作引起的出血。为此,将电极(1334)定位在横向开口(1306)的纵向延伸区中的任一者或两者旁边可以是有利的,因为这个/这些位置将靠近组织剃刮部位。Electrode (1334) may be vapor deposited on substrate (1332) or may be applied to substrate (1332) in any other suitable manner. Flexible substrate (1332) provides electrical isolation between electrode (1334) and outer shaft (1302) such that flexible substrate (1332) prevents electrode (1334) from energizing outer shaft (1302). Electrode (1334) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1332). In some versions, electrode (1334) is operable to apply bipolar RF energy to tissue in contact with electrode (1334). In some other versions, electrode (1334) is operable to apply monopolar RF energy to tissue in contact with electrode (1334). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1320) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position electrodes (1334) next to either or both of the longitudinal extensions of transverse openings (1306) since this/these locations will be close to the tissue shaving site.

虽然在图47中未示出,但柔性电路(1330)还可包括一个或多个集成导航传感器。此类导航传感器可如本文所述的其他各种导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)中的任一者来配置和操作。包括一个或多个集成导航传感器的柔性电路(1330)的型式因此可便于确定端部执行器(1310)在患者体内的实时位置。柔性电路(1330)还可包括一个或多个集成温度传感器(例如,热电偶等)。此类温度传感器可感测电极(1334)和/或与电极(1334)相邻的组织的温度。温度数据可用作实时反馈以调整RF向组织的递送(例如,以避免使组织过热)。柔性电路(1330)可包括除了或代替上述特征部的任何其他合适的特征部。作为变型的又一示例,电极(1334)可在不使用柔性电路(1330)的情况下集成到轴组件(1300)中,使得不一定需要柔性基板(1332)来将电极(1334)集成到轴组件(1300)中。Although not shown in Figure 47, the flex circuit (1330) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1330) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1310) within the patient's body. Flex circuit (1330) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1334) and/or tissue adjacent electrode (1334). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1330) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1334) can be integrated into shaft assembly (1300) without the use of flex circuit (1330) such that a flexible substrate (1332) is not necessarily required to integrate electrode (1334) into the shaft. in component(1300).

图48示出了用于剃刀器械的轴组件(1400)的示例,该轴组件结合有消融柔性电路(1430)。在图48中仅示出了剃刀器械的轴组件(1400)。轴组件(1400)包括外轴(1402)和内切割轴(1420),该内切割轴被驱动以相对于外轴(1402)围绕由轴组件(1400)限定的纵向轴线旋转。轴组件(1400)限定端部执行器(1410),该端部执行器由形成在外轴(1402)的远侧端部(1404)处的横向开口(1406)形成,锯齿状切割边缘(1408)沿开口(1406)的周边延伸。切割轴(1420)定位在外轴(1402)内部并且包括与横向开口(1406)和切割边缘(1408)互补的类似的横向开口和切割边缘(1422)。马达(未示出)能够操作以驱动内切割轴(1420)相对于外轴(1402)围绕由轴组件(1400)限定的纵向轴线旋转。抽吸源(未示出)能够操作以对通过切割轴(1420)形成的内腔施加抽吸,以由此将组织吸取到横向开口(1406)中。当切割轴(1420)相对于外轴(1402)旋转时,切割边缘(1408,1422)协作以剪切组织,并且剪切的组织在抽吸的影响下朝近侧被吸取通过切割轴的内腔。Figure 48 shows an example of a shaft assembly (1400) for a razor instrument incorporating an ablation flex circuit (1430). Only the shaft assembly (1400) of the razor instrument is shown in Figure 48. Shaft assembly (1400) includes an outer shaft (1402) and an inner cutting shaft (1420) driven for rotation relative to outer shaft (1402) about a longitudinal axis defined by shaft assembly (1400). Shaft assembly (1400) defines an end effector (1410) formed by a lateral opening (1406) formed at a distal end (1404) of outer shaft (1402), a serrated cutting edge (1408) Extends along the perimeter of opening (1406). Cutting shaft (1420) is positioned within outer shaft (1402) and includes similar lateral openings and cutting edges (1422) complementary to lateral openings (1406) and cutting edges (1408). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1420) relative to the outer shaft (1402) about a longitudinal axis defined by the shaft assembly (1400). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1420) to thereby draw tissue into the lateral opening (1406). As the cutting shaft (1420) rotates relative to the outer shaft (1402), the cutting edges (1408, 1422) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

本示例的柔性电路(1430)包括纵向延伸的柔性基板部分(1432)、周向延伸的柔性基板部分(1434)和多个电极(1436)。柔性电路(1430)可具有仅一个单层或多个层。柔性基板部分(1432,1434)一体地形成在一起,周向延伸的柔性基板部分(1434)恰好定位在横向开口(1406)的近侧。柔性基板部分(1432,1434)均由电绝缘柔性塑料材料形成,诸如聚酰亚胺或LCP。在一些型式中,基板部分(1432,1434)经由粘合剂固定到外轴(1402)的外表面。另选地,柔性基板部分(1432,1434)可以任何其他合适的方式固定到外轴(1402)。虽然纵向延伸的柔性基板部分(1432)被示出为仅沿外轴(1402)的一侧延伸,但是另一纵向延伸的柔性基板部分(1432)可沿外轴(1402)的另一侧延伸。另外,一些型式的柔性电路(1430)可包括围绕外轴(1402)的远侧端部(1404)包裹的柔性基板部分。The flexible circuit (1430) of this example includes a longitudinally extending flexible substrate portion (1432), a circumferentially extending flexible substrate portion (1434), and a plurality of electrodes (1436). Flexible circuit (1430) may have only a single layer or multiple layers. The flexible substrate portions (1432, 1434) are integrally formed together, with the circumferentially extending flexible substrate portion (1434) positioned just proximal of the transverse opening (1406). The flexible substrate portions (1432, 1434) are each formed from an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, base plate portions (1432, 1434) are secured to the outer surface of outer shaft (1402) via adhesive. Alternatively, the flexible substrate portions (1432, 1434) may be secured to the outer shaft (1402) in any other suitable manner. Although one longitudinally extending flexible substrate portion (1432) is shown extending along only one side of the outer axis (1402), another longitudinally extending flexible substrate portion (1432) may extend along the other side of the outer axis (1402) . Additionally, some versions of flexible circuit (1430) may include a flexible substrate portion wrapped around the distal end (1404) of outer shaft (1402).

电极(1436)沿周向延伸的柔性基板部分(1434)定位,使得电极(1436)恰好定位在横向开口(1406)的近侧。在本示例中,电极(1436)形成为以围绕外轴(1402)的整个圆周跨越的以阵列布置的离散正方形或矩形。在一些变型中,除了电极(1436)的周向阵列之外,柔性电路(1430)还包括在横向开口(1406)的一个或两个纵向延伸区旁边纵向延伸的一个或多个电极(例如,类似于电极1336))。另外或另选地,除了电极(1436)的周向阵列之外,一些变型的柔性电路(1430)可包括在外轴(1402)的远侧端部(1404)处的一个或多个电极(例如,类似于电极1236))。The electrode (1436) is positioned along the circumferentially extending flexible substrate portion (1434) such that the electrode (1436) is positioned just proximal of the lateral opening (1406). In this example, the electrodes (1436) are formed as discrete squares or rectangles arranged in an array spanning the entire circumference about the outer axis (1402). In some variations, in addition to the circumferential array of electrodes (1436), the flexible circuit (1430) includes one or more electrodes extending longitudinally alongside one or both longitudinally extending regions of the lateral opening (1406) (e.g., Similar to electrode 1336)). Additionally or alternatively, in addition to the circumferential array of electrodes (1436), some variations of the flexible circuit (1430) may include one or more electrodes at the distal end (1404) of the outer shaft (1402) (e.g., , similar to electrode 1236)).

电极(1434)可气相沉积在基板(1432)上或者可以任何其他合适的方式施加到基板(1432)。柔性基板(1432)提供电极(1434)与外轴(1402)之间的电绝缘,使得柔性基板(1432)防止电极(1434)给外轴(1402)通电。电极(1434)经由沿柔性基板(1432)形成的迹线(未示出)与RF发生器(例如,类似于上述RF发生器(101))耦接。在一些型式中,电极(1434)能够操作以将双极RF能量施加到与电极(1434)接触的组织。在一些其他型式中,电极(1434)能够操作以将单极RF能量施加到与电极(1434)接触的组织。在此类型式中,接地垫(未示出)可在任何合适位置接触患者。不管使用双极RF能量还是单极RF能量,RF能量可在组织剃刮操作期间消融组织。可在切割轴(1420)剃刮组织的同时和/或之后施加此类RF能量,使得RF能量可阻止原本由组织剃刮操作引起的出血。为此,将电极(1434)恰好定位在横向开口(1406)的近侧可能有利的,因为该位置将靠近组织剃刮部位。Electrode (1434) may be vapor deposited on substrate (1432) or may be applied to substrate (1432) in any other suitable manner. Flexible substrate (1432) provides electrical isolation between electrode (1434) and outer shaft (1402) such that flexible substrate (1432) prevents electrode (1434) from energizing outer shaft (1402). Electrode (1434) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1432). In some versions, electrode (1434) is operable to apply bipolar RF energy to tissue in contact with electrode (1434). In some other versions, electrode (1434) is operable to apply monopolar RF energy to tissue in contact with electrode (1434). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1420) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1434) just proximal of the transverse opening (1406) since this location will be close to the tissue shaving site.

虽然在图48中未示出,但柔性电路(1430)还可包括一个或多个集成导航传感器。此类导航传感器可如本文所述的其他各种导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)中的任一者来配置和操作。包括一个或多个集成导航传感器的柔性电路(1430)的型式因此可便于确定端部执行器(1410)在患者体内的实时位置。柔性电路(1430)还可包括一个或多个集成温度传感器(例如,热电偶等)。此类温度传感器可感测电极(1434)和/或与电极(1434)相邻的组织的温度。温度数据可用作实时反馈以调整RF向组织的递送(例如,以避免使组织过热)。柔性电路(1430)可包括除了或代替上述特征部的任何其他合适的特征部。作为变型的又一示例,电极(1434)可在不使用柔性电路(1430)的情况下集成到轴组件(1400)中,使得不一定需要柔性基板(1432)来将电极(1434)集成到轴组件(1400)中。Although not shown in Figure 48, the flex circuit (1430) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1430) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1410) within the patient's body. Flexible circuit (1430) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1434) and/or tissue adjacent electrode (1434). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1430) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1434) may be integrated into shaft assembly (1400) without the use of flex circuit (1430) such that a flexible substrate (1432) is not necessarily required to integrate electrode (1434) into the shaft. in component(1400).

图49示出了用于剃刀器械的轴组件(1500)的示例,该轴组件结合有消融柔性电路(1530)。在图49中仅示出了剃刀器械的轴组件(1500)。轴组件(1500)包括外轴(1502)和内切割轴(1520),该内切割轴被驱动以相对于外轴(1502)围绕由轴组件(1500)限定的纵向轴线旋转。轴组件(1500)限定端部执行器(1510),该端部执行器由形成在外轴(1502)的远侧端部(1504)处的横向开口(1506)形成,锯齿状切割边缘(1508)沿开口(1506)的周边延伸。切割轴(1520)定位在外轴(1502)内部并且包括与横向开口(1506)和切割边缘(1508)互补的类似的横向开口和切割边缘(1522)。马达(未示出)能够操作以驱动内切割轴(1520)相对于外轴(1502)围绕由轴组件(1500)限定的纵向轴线旋转。抽吸源(未示出)能够操作以对通过切割轴(1520)形成的内腔施加抽吸,以由此将组织吸取到横向开口(1506)中。当切割轴(1520)相对于外轴(1502)旋转时,切割边缘(1508,1522)协作以剪切组织,并且剪切的组织在抽吸的影响下朝近侧被吸取通过切割轴的内腔。Figure 49 shows an example of a shaft assembly (1500) for a razor instrument incorporating an ablation flex circuit (1530). Only the shaft assembly (1500) of the razor instrument is shown in Figure 49. Shaft assembly (1500) includes an outer shaft (1502) and an inner cutting shaft (1520) driven for rotation relative to outer shaft (1502) about a longitudinal axis defined by shaft assembly (1500). Shaft assembly (1500) defines an end effector (1510) formed by a lateral opening (1506) formed at a distal end (1504) of outer shaft (1502), a serrated cutting edge (1508) Extends along the perimeter of opening (1506). Cutting shaft (1520) is positioned within outer shaft (1502) and includes similar lateral openings and cutting edges (1522) complementary to lateral openings (1506) and cutting edges (1508). A motor (not shown) is operable to drive rotation of the inner cutting shaft (1520) relative to the outer shaft (1502) about a longitudinal axis defined by the shaft assembly (1500). A suction source (not shown) is operable to apply suction to the lumen formed by the cutting shaft (1520) to thereby draw tissue into the lateral opening (1506). As the cutting shaft (1520) rotates relative to the outer shaft (1502), the cutting edges (1508, 1522) cooperate to shear tissue, and the sheared tissue is drawn proximally through the inner portion of the cutting shaft under the influence of suction. cavity.

本示例的柔性电路(1530)包括纵向延伸的柔性基板部分(1532)、周向延伸的柔性基板部分(1534)和一对电极(1536)。柔性电路(1530)可具有仅一个单层或多个层。柔性基板部分(1532,1534)一体地形成在一起,周向延伸的柔性基板部分(1534)恰好定位在横向开口(1506)的近侧。柔性基板部分(1532,1534)均由电绝缘柔性塑料材料形成,诸如聚酰亚胺或LCP。在一些型式中,基板部分(1532,1534)经由粘合剂固定到外轴(1502)的外表面。另选地,柔性基板部分(1532,1534)可以任何其他合适的方式固定到外轴(1502)。虽然纵向延伸的柔性基板部分(1532)被示出为仅沿外轴(1502)的一侧延伸,但是另一纵向延伸的柔性基板部分(1532)可沿外轴(1502)的另一侧延伸。另外,一些型式的柔性电路(1530)可包括围绕外轴(1502)的远侧端部(1504)包裹的柔性基板部分。The flexible circuit (1530) of this example includes a longitudinally extending flexible substrate portion (1532), a circumferentially extending flexible substrate portion (1534), and a pair of electrodes (1536). Flexible circuit (1530) may have only a single layer or multiple layers. The flexible substrate portions (1532, 1534) are integrally formed together, with the circumferentially extending flexible substrate portion (1534) positioned just proximal of the transverse opening (1506). The flexible substrate portions (1532, 1534) are each formed from an electrically insulating flexible plastic material, such as polyimide or LCP. In some versions, base plate portions (1532, 1534) are secured to the outer surface of outer shaft (1502) via adhesive. Alternatively, the flexible substrate portions (1532, 1534) may be secured to the outer shaft (1502) in any other suitable manner. Although one longitudinally extending flexible substrate portion (1532) is shown extending along only one side of the outer axis (1502), another longitudinally extending flexible substrate portion (1532) may extend along the other side of the outer axis (1502) . Additionally, some versions of flexible circuit (1530) may include a flexible substrate portion wrapped around the distal end (1504) of outer shaft (1502).

电极(1536)沿周向延伸的柔性基板部分(1534)定位,使得电极(1536)恰好定位在横向开口(1506)的近侧。在本示例中,电极(1536)形成为一起围绕外轴(1502)的圆周跨越的两个离散条带,在电极(1536)的自由端之间限定小间隙。电极(1536)因此是大体上半圆形的。在一些变型中,除了电极(1536)的周向布置之外,柔性电路(1530)还包括在横向开口(1506)的一个或两个纵向延伸区旁边纵向延伸的一个或多个电极(例如,类似于电极1336))。另外或另选地,除了电极(1536)的周向布置之外,一些变型的柔性电路(1530)可包括在外轴(1502)的远侧端部(1504)处的一个或多个电极(例如,类似于电极1236))。The electrode (1536) is positioned along the circumferentially extending flexible substrate portion (1534) such that the electrode (1536) is positioned just proximal to the lateral opening (1506). In this example, the electrodes (1536) are formed as two discrete strips that span together around the circumference of the outer axis (1502), defining a small gap between the free ends of the electrodes (1536). The electrode (1536) is therefore generally semicircular. In some variations, in addition to the circumferential arrangement of electrodes (1536), flexible circuit (1530) includes one or more electrodes extending longitudinally alongside one or both longitudinally extending regions of lateral opening (1506) (e.g., Similar to electrode 1336)). Additionally or alternatively, in addition to the circumferential arrangement of electrodes (1536), some variations of the flexible circuit (1530) may include one or more electrodes (e.g., , similar to electrode 1236)).

电极(1534)可气相沉积在基板(1532)上或者可以任何其他合适的方式施加到基板(1532)。柔性基板(1532)提供电极(1534)与外轴(1502)之间的电绝缘,使得柔性基板(1532)防止电极(1534)给外轴(1502)通电。电极(1534)经由沿柔性基板(1532)形成的迹线(未示出)与RF发生器(例如,类似于上述RF发生器(101))耦接。在一些型式中,电极(1534)能够操作以将双极RF能量施加到与电极(1534)接触的组织。在一些其他型式中,电极(1534)能够操作以将单极RF能量施加到与电极(1534)接触的组织。在此类型式中,接地垫(未示出)可在任何合适位置接触患者。不管使用双极RF能量还是单极RF能量,RF能量可在组织剃刮操作期间消融组织。可在切割轴(1520)剃刮组织的同时和/或之后施加此类RF能量,使得RF能量可阻止原本由组织剃刮操作引起的出血。为此,将电极(1534)恰好定位在横向开口(1506)的近侧可能有利的,因为该位置将靠近组织剃刮部位。Electrode (1534) may be vapor deposited on substrate (1532) or may be applied to substrate (1532) in any other suitable manner. Flexible substrate (1532) provides electrical insulation between electrode (1534) and outer shaft (1502) such that flexible substrate (1532) prevents electrode (1534) from energizing outer shaft (1502). Electrode (1534) is coupled to an RF generator (eg, similar to RF generator (101) described above) via traces (not shown) formed along flexible substrate (1532). In some versions, electrode (1534) is operable to apply bipolar RF energy to tissue in contact with electrode (1534). In some other versions, electrode (1534) is operable to apply monopolar RF energy to tissue in contact with electrode (1534). In this type of version, a ground pad (not shown) can contact the patient at any suitable location. Whether bipolar or monopolar RF energy is used, the RF energy can ablate tissue during the tissue shaving operation. Such RF energy may be applied while and/or after the cutting shaft (1520) shaves tissue such that the RF energy may prevent bleeding that would otherwise result from the tissue shaving operation. To this end, it may be advantageous to position the electrode (1534) just proximal to the lateral opening (1506) since this location will be close to the tissue shaving site.

虽然在图49中未示出,但柔性电路(1530)还可包括一个或多个集成导航传感器。此类导航传感器可如本文所述的其他各种导航传感器(150,152,154,156,250,252,254,256,452,453,552,553,650,652,653,654,656,657,1144,1146)中的任一者来配置和操作。包括一个或多个集成导航传感器的柔性电路(1530)的型式因此可便于确定端部执行器(1510)在患者体内的实时位置。柔性电路(1530)还可包括一个或多个集成温度传感器(例如,热电偶等)。此类温度传感器可感测电极(1534)和/或与电极(1534)相邻的组织的温度。温度数据可用作实时反馈以调整RF向组织的递送(例如,以避免使组织过热)。柔性电路(1530)可包括除了或代替上述特征部的任何其他合适的特征部。作为变型的又一示例,电极(1534)可在不使用柔性电路(1530)的情况下集成到轴组件(1400)中,使得不一定需要柔性基板(1532)来将电极(1534)集成到轴组件(1500)中。Although not shown in Figure 49, the flex circuit (1530) may also include one or more integrated navigation sensors. Such navigation sensors may be configured and operated as any of the various other navigation sensors described herein (150, 152, 154, 156, 250, 252, 254, 256, 452, 453, 552, 553, 650, 652, 653, 654, 656, 657, 1144, 1146). A version of the flexible circuit (1530) that includes one or more integrated navigation sensors may therefore facilitate determining the real-time position of the end effector (1510) within the patient's body. Flex circuit (1530) may also include one or more integrated temperature sensors (eg, thermocouples, etc.). Such temperature sensors may sense the temperature of electrode (1534) and/or tissue adjacent electrode (1534). Temperature data can be used as real-time feedback to adjust the delivery of RF to tissue (eg, to avoid overheating the tissue). Flexible circuit (1530) may include any other suitable features in addition to or in place of the features described above. As yet another example of a variation, electrode (1534) may be integrated into shaft assembly (1400) without the use of flex circuit (1530) such that a flexible substrate (1532) is not necessarily required to integrate electrode (1534) into the shaft. in component(1500).

虽然柔性电路(1230,1330,1430,1530)在组织剃刮器械轴组件(1200,1300,1400,1500)的情况下被示出和描述,但是柔性电路组件(如柔性电路(1230,1330,1430,1530))可容易地与任何其他合适种类的器械一起使用。柔性电路组件(如柔性电路(1230,1330,1430,1530))不必限于组织剃刮器械的情况。仅以举例的方式,柔性电路组件(如柔性电路(1230,1330,1430,1530))可与内窥镜、不同种类的ENT器械和/或参考本文的教导内容对本领域的技术人员而言将显而易见的任何其他种类的器械集成。Although the flexible circuit (1230, 1330, 1430, 1530) is shown and described in the context of the tissue shaving instrument shaft assembly (1200, 1300, 1400, 1500), the flexible circuit assembly (e.g., the flexible circuit (1230, 1330, 1430,1530)) can be easily used with any other suitable kind of instrument. Flexible circuit components, such as flexible circuits (1230, 1330, 1430, 1530), need not be limited to the context of tissue shaving devices. By way of example only, flexible circuit assemblies such as flexible circuits (1230, 1330, 1430, 1530) may be used with endoscopes, different types of ENT devices, and/or as will become apparent to those skilled in the art in light of the teachings herein. Any other kind of instrument integration is obvious.

VI.示例性组合VI.Exemplary combinations

以下实施例涉及本文的教导内容可被组合或应用的各种非穷尽性方式。应当理解,以下实施例并非旨在限制可在本专利申请或本专利申请的后续提交文件中的任何时间提供的任何权利要求的覆盖范围。不旨在进行免责声明。提供以下实施例仅仅是出于例示性目的。预期本文的各种教导内容可按多种其他方式进行布置和应用。还设想到,一些变型可省略在以下实施例中所提及的某些特征。因此,下文提及的方面或特征中的任一者均不应被视为决定性的,除非另外例如由发明人或与发明人有利害关系的继承者在稍后日期明确指明如此。如果本专利申请或与本专利申请相关的后续提交文件中提出的任何权利要求包括下文提及的那些特征之外的附加特征,则这些附加特征不应被假定为因与专利性相关的任何原因而被添加。The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. It should be understood that the following examples are not intended to limit the coverage of any claims that may be presented at any time in this patent application or in a subsequent filing of this patent application. No disclaimer is intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Accordingly, none of the aspects or features mentioned below should be considered decisive unless otherwise expressly stated so, for example by the inventor or a successor interested in the inventor at a later date. If any claim set forth in this patent application or in subsequent filings related to this patent application includes additional features beyond those mentioned below, these additional features shall not be assumed for any reason relevant to patentability And was added.

实施例1Example 1

一种ENT外科器械,包括:(a)轴组件,所述轴组件具有远侧端部,所述远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中;(b)柔性基板,所述柔性基板沿所述轴的至少一部分延伸;以及(c)至少一个导电传感器迹线,所述至少一个导电传感器迹线形成在所述柔性基板上,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定至少一个导航传感器。An ENT surgical instrument comprising: (a) a shaft assembly having a distal end sized and configured to fit within the ear, nose, or throat of a patient; in the anatomical channel; (b) a flexible substrate extending along at least a portion of the shaft; and (c) at least one conductive sensor trace formed on the flexible substrate, wherein said at least one sensor trace includes at least one concentric ring portion, wherein said at least one concentric ring portion defines at least one navigation sensor.

实施例2Example 2

根据实施例1所述的ENT外科器械,其中所述至少一个导航传感器包括近侧导航传感器和至少一个远侧导航传感器。The ENT surgical instrument of embodiment 1, wherein the at least one navigation sensor includes a proximal navigation sensor and at least one distal navigation sensor.

实施例3Example 3

根据实施例2所述的ENT外科器械,其中所述至少一个远侧导航传感器包括一对侧向相邻的远侧导航传感器。The ENT surgical instrument of embodiment 2, wherein the at least one distal navigation sensor includes a pair of laterally adjacent distal navigation sensors.

实施例4Example 4

根据实施例2至3中任一项所述的ENT外科器械,其中所述近侧导航传感器和所述远侧导航传感器彼此电隔离。The ENT surgical instrument of any one of embodiments 2-3, wherein the proximal navigation sensor and the distal navigation sensor are electrically isolated from each other.

实施例5 Example 5

根据实施例1至4中任一项所述的ENT外科器械,其中所述柔性基板包括顶部表面和底部表面,其中所述至少一个导航传感器包括定位在所述顶部表面上的顶部导航传感器和定位在所述底部表面上的与所述顶部导航传感器相对的底部导航传感器。The ENT surgical instrument of any one of embodiments 1 to 4, wherein the flexible substrate includes a top surface and a bottom surface, and wherein the at least one navigation sensor includes a top navigation sensor positioned on the top surface and a positioning A bottom navigation sensor on the bottom surface opposite the top navigation sensor.

实施例6Example 6

根据实施例5所述的ENT外科器械,其中所述顶部导航传感器和所述底部导航传感器彼此电耦接。The ENT surgical instrument of embodiment 5, wherein the top navigation sensor and the bottom navigation sensor are electrically coupled to each other.

实施例7Example 7

根据实施例1至6中任一项所述的ENT外科器械,还包括电耦接到所述至少一个传感器迹线的近侧端部的至少一个传感器引线,其中所述至少一个传感器引线被配置成操作地耦接到处理器。The ENT surgical instrument of any one of embodiments 1-6, further comprising at least one sensor lead electrically coupled to a proximal end of the at least one sensor trace, wherein the at least one sensor lead is configured operatively coupled to the processor.

实施例8Example 8

根据实施例7所述的ENT外科器械,其中所述至少一个传感器引线相对于所述至少一个导航传感器定位在近侧。The ENT surgical instrument of embodiment 7, wherein the at least one sensor lead is positioned proximally relative to the at least one navigation sensor.

实施例9Example 9

根据实施例1至8中任一项所述的ENT外科器械,其中所述柔性基板为矩形或蛇形中的至少一者。The ENT surgical instrument according to any one of embodiments 1 to 8, wherein the flexible substrate is at least one of a rectangular shape or a serpentine shape.

实施例10Example 10

根据实施例1至9中任一项所述的ENT外科器械,其中所述柔性基板被构造成在平坦构型与至少一个弯曲构型之间转变。The ENT surgical instrument of any one of embodiments 1-9, wherein the flexible substrate is configured to transition between a flat configuration and at least one curved configuration.

实施例11Example 11

根据实施例1至10中任一项所述的ENT外科器械,所述轴组件包括轴构件,其中所述柔性基板固定到所述轴构件。The ENT surgical instrument of any one of embodiments 1 to 10, the shaft assembly includes a shaft member, wherein the flexible base plate is secured to the shaft member.

实施例12Example 12

根据实施例11所述的ENT外科器械,其中所述轴构件包括内弦,其中所述柔性基板以平坦构型沿所述内弦设置。The ENT surgical instrument of embodiment 11, wherein the shaft member includes an inner chord, and wherein the flexible substrate is disposed along the inner chord in a flat configuration.

实施例13Example 13

根据实施例11所述的ENT外科器械,其中所述轴构件包括柱形内表面,其中所述柔性基板以至少一个弯曲构型沿所述柱形内表面设置。The ENT surgical instrument of embodiment 11, wherein the shaft member includes a cylindrical inner surface, and wherein the flexible substrate is disposed along the cylindrical inner surface in at least one curved configuration.

实施例14Example 14

根据实施例11所述的ENT外科器械,其中所述轴构件包括柱形外表面,其中所述柔性基板以至少一个弯曲构型沿所述柱形外表面设置。The ENT surgical instrument of embodiment 11, wherein the shaft member includes a cylindrical outer surface, and wherein the flexible substrate is disposed along the cylindrical outer surface in at least one curved configuration.

实施例15Example 15

根据实施例1至14中任一项所述的ENT外科器械,其中所述轴组件包括柔性部分,其中所述柔性基板沿所述柔性部分延伸。The ENT surgical instrument of any one of embodiments 1 to 14, wherein the shaft assembly includes a flexible portion, and wherein the flexible base plate extends along the flexible portion.

实施例16Example 16

一种ENT外科器械,包括:(a)轴组件,所述轴组件具有远侧端部,所述远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中;(b)柔性基板,所述柔性基板沿所述轴的至少一部分延伸,所述柔性基板具有顶部表面和底部表面;(c)近侧顶部导电传感器迹线,所述近侧顶部导电传感器迹线形成在所述顶部表面上,其中所述近侧顶部传感器迹线包括近侧顶部同心环部分,其中所述近侧顶部同心环部分限定近侧顶部导航传感器;(d)至少一个远侧顶部导电传感器迹线,所述至少一个远侧顶部导电传感器迹线形成在所述顶部表面上,其中所述至少一个远侧顶部传感器迹线包括至少一个远侧顶部同心环部分,其中所述至少一个远侧顶部同心环部分限定至少一个远侧顶部导航传感器;(e)近侧底部导电传感器迹线,所述近侧底部导电传感器迹线形成在所述底部表面上,其中所述近侧底部传感器迹线包括近侧底部同心环部分,其中所述近侧底部同心环部分限定近侧底部导航传感器;(f)至少一个远侧底部导电传感器迹线,所述至少一个远侧底部导电传感器迹线形成在所述底部表面上,其中所述至少一个远侧底部传感器迹线包括至少一个远侧底部同心环部分,其中所述至少一个远侧底部同心环部分限定至少一个远侧底部导航传感器。An ENT surgical instrument comprising: (a) a shaft assembly having a distal end sized and configured to fit within the ear, nose, or throat of a patient; in the anatomical channel; (b) a flexible substrate extending along at least a portion of the shaft, the flexible substrate having a top surface and a bottom surface; (c) a proximal top conductive sensor trace, the proximal top A conductive sensor trace is formed on the top surface, wherein the proximal top sensor trace includes a proximal top concentric ring portion, wherein the proximal top concentric ring portion defines a proximal top navigation sensor; (d) at least one a distal top conductive sensor trace, the at least one distal top conductive sensor trace being formed on the top surface, wherein the at least one distal top sensor trace includes at least one distal top concentric ring portion, wherein the at least one distal top conductive sensor trace the at least one distal top concentric ring portion defines at least one distal top navigation sensor; (e) a proximal bottom conductive sensor trace formed on the bottom surface, wherein the proximal bottom conductive sensor trace is formed on the bottom surface, wherein the proximal bottom conductive sensor trace is formed on the bottom surface; a side bottom sensor trace including a proximal bottom concentric ring portion, wherein the proximal bottom concentric ring portion defines a proximal bottom navigation sensor; (f) at least one distal bottom conductive sensor trace, the at least one distal bottom conductive A sensor trace is formed on the bottom surface, wherein the at least one distal bottom sensor trace includes at least one distal bottom concentric ring portion, wherein the at least one distal bottom concentric ring portion defines at least one distal bottom navigation sensor.

实施例17Example 17

根据实施例16所述的ENT外科器械,其中所述近侧底部传感器迹线定位成与所述近侧顶部传感器迹线相对,其中所述至少一个远侧底部传感器迹线定位成与所述至少一个远侧顶部传感器迹线相对。The ENT surgical instrument of embodiment 16, wherein the proximal bottom sensor trace is positioned opposite the proximal top sensor trace, wherein the at least one distal bottom sensor trace is positioned opposite the at least one A far side top sensor trace is opposite.

实施例18Example 18

根据实施例16至17中任一项所述的ENT外科器械,其中所述至少一个远侧顶部传感器迹线包括一对侧向相邻的远侧顶部传感器迹线,其中所述至少一个远侧底部传感器迹线包括一对侧向相邻的远侧底部传感器迹线。The ENT surgical instrument of any one of embodiments 16-17, wherein the at least one distal top sensor trace includes a pair of laterally adjacent distal top sensor traces, wherein the at least one distal top sensor trace The bottom sensor traces include a pair of laterally adjacent distal bottom sensor traces.

实施例19Example 19

一种使用ENT外科器械的方法,所述ENT外科器械具有(i)柔性基板和(ii)形成在所述柔性基板上的至少一个导电传感器迹线,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定至少一个导航传感器,所述方法包括:(a)将所述柔性基板插入患者的耳、鼻或喉中的至少一者内的解剖通道中;(b)将所述至少一个导航传感器暴露于电磁场;(c)响应于将所述至少一个导航传感器暴露于所述电磁场的行为,经由所述至少一个导航传感器生成信号;(d)基于所生成的信号来导航所述ENT外科器械的远侧部分通过所述解剖通道;以及(e)经由所述ENT外科器械治疗所述解剖通道。A method of using an ENT surgical instrument having (i) a flexible substrate and (ii) at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one Concentric ring portions, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising: (a) inserting the flexible substrate into an anatomical passage within at least one of the patient's ear, nose, or throat; (b) exposing the at least one navigation sensor to an electromagnetic field; (c) generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field; (d) based on the generated signals to navigate a distal portion of the ENT surgical instrument through the anatomical passage; and (e) treat the anatomical passage via the ENT surgical instrument.

实施例20Example 20

根据实施例19所述的方法,其中经由所述ENT外科器械治疗所述解剖通道的行为包括扩张所述解剖通道、向所述解剖通道内的组织施加RF能量、切断所述解剖通道内的组织或从所述解剖通道移除碎屑中的至少一者。The method of embodiment 19, wherein treating the anatomical passage via the ENT surgical instrument includes dilating the anatomical passage, applying RF energy to tissue within the anatomical passage, severing tissue within the anatomical passage or removing at least one of the debris from the anatomical passage.

实施例21Example 21

一种设备,包括:(a)轴组件,所述轴组件具有远侧端部,所述远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中;(b)柔性基板,所述柔性基板沿所述轴的至少一部分延伸;(c)至少一个导航传感器,所述至少一个导航传感器定位在所述柔性基板上;以及(d)至少一个导电相机迹线,所述至少一个导电相机迹线形成在所述柔性基板上,其中所述至少一个相机迹线被配置成将相机操作地耦接到处理器或功率源中的至少一者。An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a flexible substrate extending along at least a portion of the axis; (c) at least one navigation sensor positioned on the flexible substrate; and (d) at least one electrically conductive A camera trace, the at least one conductive camera trace is formed on the flexible substrate, wherein the at least one camera trace is configured to operatively couple a camera to at least one of a processor or a power source.

实施例22Example 22

根据实施例21所述的设备,还包括形成在所述柔性基板上的至少一个导电传感器迹线,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定所述至少一个导航传感器。The apparatus of embodiment 21, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

实施例23Example 23

根据实施例21至22中任一项所述的设备,其中所述至少一个导航传感器包括近侧导航传感器和远侧导航传感器。The apparatus of any one of embodiments 21 to 22, wherein the at least one navigation sensor includes a proximal navigation sensor and a distal navigation sensor.

实施例24Example 24

根据实施例21至23中任一项所述的设备,其中所述柔性基板包括顶部表面和底部表面,其中所述至少一个导航传感器包括定位在所述顶部表面上的顶部导航传感器和定位在所述底部表面上的与所述顶部导航传感器相对的底部导航传感器。The apparatus of any one of embodiments 21 to 23, wherein the flexible substrate includes a top surface and a bottom surface, and wherein the at least one navigation sensor includes a top navigation sensor positioned on the top surface and a top navigation sensor positioned on the top surface. a bottom navigation sensor on the bottom surface opposite the top navigation sensor.

实施例25Example 25

根据实施例21至24中任一项所述的设备,其中所述柔性基板包括表面,其中所述至少一个导航传感器定位在所述表面上,其中所述至少一个相机迹线形成在所述表面上。The apparatus of any one of embodiments 21 to 24, wherein the flexible substrate includes a surface, wherein the at least one navigation sensor is positioned on the surface, and wherein the at least one camera trace is formed on the surface superior.

实施例26Example 26

根据实施例21至25中任一项所述的设备,还包括电耦接到所述至少一个相机迹线的近侧端部的至少一个近侧相机引线,其中所述至少一个近侧相机引线被配置成操作地耦接到处理器或功率源中的至少一者。The apparatus of any one of embodiments 21-25, further comprising at least one proximal camera lead electrically coupled to a proximal end of the at least one camera trace, wherein the at least one proximal camera lead Configured to be operatively coupled to at least one of a processor or a power source.

实施例27Example 27

根据实施例26所述的设备,其中所述至少一个近侧相机引线相对于所述至少一个导航传感器定位在近侧。The device of embodiment 26, wherein the at least one proximal camera lead is positioned proximally relative to the at least one navigation sensor.

实施例28Example 28

根据实施例21至27中任一项所述的设备,还包括电耦接到所述至少一个相机迹线的远侧端部的至少一个远侧相机引线,其中所述至少一个远侧相机引线被配置成操作地耦接到所述相机。The apparatus of any one of embodiments 21-27, further comprising at least one distal camera lead electrically coupled to a distal end of the at least one camera trace, wherein the at least one distal camera lead configured to be operatively coupled to the camera.

实施例29Example 29

根据实施例28所述的设备,其中所述至少一个远侧相机引线相对于所述至少一个导航传感器定位在远侧。The device of embodiment 28, wherein the at least one distal camera lead is positioned distally relative to the at least one navigation sensor.

实施例30Example 30

根据实施例21至29中任一项所述的设备,其中所述至少一个相机迹线包括多个相机迹线。The apparatus of any one of embodiments 21 to 29, wherein the at least one camera trace includes a plurality of camera traces.

实施例31Example 31

根据实施例30所述的设备,其中所述多个相机迹线侧向地位于所述至少一个导航传感器的侧面。The apparatus of embodiment 30, wherein the plurality of camera traces are located laterally to the side of the at least one navigation sensor.

实施例32Example 32

根据实施例21至31中任一项所述的设备,还包括所述相机,其中所述至少一个相机迹线操作地耦接到所述相机。The apparatus of any one of embodiments 21-31, further comprising the camera, wherein the at least one camera trace is operatively coupled to the camera.

实施例33Example 33

根据实施例21至32中任一项所述的设备,还包括所述处理器或所述功率源中的至少一者,其中所述至少一个相机迹线操作地耦接到处理器或所述功率源中的所述至少一者。The apparatus of any one of embodiments 21-32, further comprising at least one of the processor or the power source, wherein the at least one camera trace is operatively coupled to the processor or the power source. The at least one of the power sources.

实施例34Example 34

根据实施例21至33中任一项所述的设备,所述轴组件包括柔性部分,所述柔性基板固定到所述柔性部分,所述柔性基板进一步被构造成与所述柔性部分一起弯曲。The apparatus of any one of embodiments 21 to 33, the shaft assembly including a flexible portion, the flexible base plate being secured to the flexible portion, the flexible base plate being further configured to flex with the flexible portion.

实施例35Example 35

根据实施例21至34中任一项所述的设备,所述轴组件包括能够操作以向组织施加RF能量的一个或多个电极。The device of any one of embodiments 21 to 34, the shaft assembly includes one or more electrodes operable to apply RF energy to tissue.

实施例36Example 36

一种设备,包括:(a)相机;(b)处理器;(c)功率源;(d)柔性基板;(e)至少一个导航传感器,所述至少一个导航传感器定位在所述柔性基板上;以及(f)第一导电相机迹线和第二导电相机迹线,所述第一导电相机迹线和所述第二导电相机迹线形成在所述柔性基板上,其中所述第一相机迹线将所述相机操作地耦接到所述处理器,其中所述第二相机迹线将所述相机操作地耦接到所述功率源。A device comprising: (a) a camera; (b) a processor; (c) a power source; (d) a flexible substrate; (e) at least one navigation sensor positioned on the flexible substrate ; and (f) a first conductive camera trace and a second conductive camera trace formed on the flexible substrate, wherein the first camera trace and the second conductive camera trace are formed on the flexible substrate. A trace operatively couples the camera to the processor, wherein the second camera trace operatively couples the camera to the power source.

实施例37Example 37

根据实施例36所述的设备,还包括形成在所述柔性基板上的至少一个导电传感器迹线,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定所述至少一个导航传感器。The apparatus of embodiment 36, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.

实施例38Example 38

一种使用设备的方法,所述设备具有(i)柔性基板、(ii)定位在所述柔性基板上的至少一个导航传感器和(iii)形成在所述柔性基板上的至少一个导电相机迹线,所述方法包括:(a)经由所述至少一个相机迹线将相机操作地耦接到处理器或功率源中的至少一者;(b)将所述柔性基板插入患者的解剖通道中;(c)将所述至少一个导航传感器暴露于电磁场;(d)响应于将所述至少一个导航传感器暴露于所述电磁场的行为,经由所述至少一个导航传感器生成信号;(e)基于所生成的信号来导航所述设备的远侧部分通过所述解剖通道;以及(f)经由所述相机使所述解剖通道的位于所述设备的所述远侧部分远侧的一部分可视化。A method of using a device having (i) a flexible substrate, (ii) at least one navigation sensor positioned on the flexible substrate, and (iii) at least one conductive camera trace formed on the flexible substrate , the method includes: (a) operatively coupling a camera to at least one of a processor or a power source via the at least one camera trace; (b) inserting the flexible substrate into an anatomical passage of a patient; (c) exposing the at least one navigation sensor to an electromagnetic field; (d) generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field; (e) based on the generated signals to navigate the distal portion of the device through the anatomical channel; and (f) visualizing, via the camera, a portion of the anatomical channel distal to the distal portion of the device.

实施例39Example 39

根据实施例38所述的方法,其中导航所述设备的所述远侧部分通过所述解剖通道的行为包括弯曲所述柔性基板。The method of embodiment 38, wherein navigating the distal portion of the device through the anatomical passage includes bending the flexible base plate.

实施例40Example 40

根据实施例38至39中任一项所述的方法,还包括向所述解剖通道内的组织施加RF能量。The method of any one of embodiments 38-39, further comprising applying RF energy to tissue within the anatomical channel.

实施例41Example 41

一种设备,包括:(a)轴组件,所述轴组件具有远侧端部,所述远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中;(b)基板,所述基板沿所述轴的至少一部分定位;(c)至少一个导电传感器迹线,所述至少一个导电传感器迹线形成在所述基板上,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定至少一个导航传感器;以及(d)至少一个温度传感器,所述至少一个温度传感器定位在所述基板上。An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a substrate positioned along at least a portion of the axis; (c) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor The trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and (d) at least one temperature sensor positioned on the substrate.

实施例42Example 42

根据实施例41所述的设备,其中所述至少一个温度传感器被配置成检测所述至少一个传感器迹线的温度。The apparatus of embodiment 41, wherein the at least one temperature sensor is configured to detect the temperature of the at least one sensor trace.

实施例43Example 43

根据实施例42所述的设备,其中所述至少一个温度传感器包括热电偶或热敏电阻中的至少一者。The apparatus of embodiment 42, wherein the at least one temperature sensor includes at least one of a thermocouple or a thermistor.

实施例44Example 44

根据实施例42至43中任一项所述的设备,还包括处理器,其中所述处理器操作地耦接到所述至少一个导航传感器和所述至少一个温度传感器,使得所述至少一个导航传感器能够操作以将位置信号传送到所述处理器,并且使得所述至少一个温度传感器能够操作以将温度信号传送到所述处理器。The apparatus of any one of embodiments 42-43, further comprising a processor, wherein the processor is operatively coupled to the at least one navigation sensor and the at least one temperature sensor such that the at least one navigation sensor A sensor is operable to transmit a position signal to the processor, and the at least one temperature sensor is operable to transmit a temperature signal to the processor.

实施例45Example 45

根据实施例44所述的设备,其中所述处理器被配置成基于由所述至少一个导航传感器传送到所述处理器的所述位置信号并且基于由所述至少一个温度传感器传送到所述处理器的所述温度信号来确定位置坐标。The apparatus of embodiment 44, wherein the processor is configured to process based on the position signal transmitted to the processor by the at least one navigation sensor and based on the position signal transmitted to the processor by the at least one temperature sensor The temperature signal of the device is used to determine the position coordinates.

实施例46Example 46

根据实施例45所述的设备,其中所述处理器被配置成响应于指示所检测到的温度的变化的所述温度信号而将校正因子应用于所述位置坐标。The apparatus of embodiment 45, wherein the processor is configured to apply a correction factor to the location coordinates in response to the temperature signal indicating a change in the detected temperature.

实施例47Example 47

根据实施例45至46中任一项所述的设备,其中所述处理器被配置成将所检测到的温度的变化与所述至少一个传感器迹线的电阻的变化相关联。The apparatus of any one of embodiments 45 to 46, wherein the processor is configured to correlate changes in the detected temperature with changes in resistance of the at least one sensor trace.

实施例48Example 48

根据实施例41至47中任一项所述的设备,其中所述基板包括表面,其中所述至少一个导航传感器定位在所述表面上,其中所述至少一个温度传感器定位在所述表面上。The apparatus of any one of embodiments 41 to 47, wherein the substrate includes a surface, wherein the at least one navigation sensor is positioned on the surface, and wherein the at least one temperature sensor is positioned on the surface.

实施例49Example 49

根据实施例41至48中任一项所述的设备,其中所述基板是柔性的。The device of any one of embodiments 41 to 48, wherein the substrate is flexible.

实施例50Example 50

根据实施例41至49中任一项所述的设备,其中所述至少一个导航传感器包括近侧导航传感器和远侧导航传感器。The apparatus of any one of embodiments 41 to 49, wherein the at least one navigation sensor includes a proximal navigation sensor and a distal navigation sensor.

实施例51Example 51

根据实施例50所述的设备,其中所述至少一个温度传感器包括定位在所述近侧导航传感器附近的至少一个近侧温度传感器,以及定位在所述远侧导航传感器附近的至少一个远侧温度传感器。The apparatus of embodiment 50, wherein the at least one temperature sensor includes at least one proximal temperature sensor positioned adjacent the proximal navigation sensor, and at least one distal temperature sensor positioned adjacent the distal navigation sensor sensor.

实施例52Example 52

根据实施例51所述的设备,其中所述至少一个近侧温度传感器相对于所述近侧导航传感器定位在近侧,其中所述至少一个远侧温度传感器相对于所述远侧导航传感器定位在近侧并且相对于所述近侧导航传感器定位在远侧。The apparatus of embodiment 51, wherein the at least one proximal temperature sensor is positioned proximally relative to the proximal navigation sensor, and wherein the at least one distal temperature sensor is positioned proximally relative to the distal navigation sensor. proximal and positioned distally relative to the proximal navigation sensor.

实施例53Example 53

根据实施例41至52中任一项所述的设备,其中所述至少一个温度传感器包括一对侧向相邻的温度传感器。The apparatus of any one of embodiments 41 to 52, wherein the at least one temperature sensor includes a pair of laterally adjacent temperature sensors.

实施例54Example 54

一种ENT外科器械,包括:(a)动力部件,所述动力部件被配置成生成热量;以及(b)根据实施例41至53中任一项所述的设备,其中所述至少一个导航传感器暴露于由所述动力部件生成的热量。An ENT surgical instrument comprising: (a) a powered component configured to generate heat; and (b) the device of any one of embodiments 41 to 53, wherein the at least one navigation sensor Exposure to heat generated by the power components.

实施例55Example 55

根据实施例54所述的ENT外科器械,其中所述动力部件包括(i)被配置成向组织递送RF能量的电极,或(ii)被配置成驱动用于切断组织的切割构件的马达中的至少一者。The ENT surgical instrument of embodiment 54, wherein the powered component includes (i) an electrode configured to deliver RF energy to tissue, or (ii) a motor configured to drive a cutting member for severing tissue. At least one.

实施例56Example 56

一种设备,包括:(a)轴组件,所述轴组件具有远侧端部,所述远侧端部的大小和构型被设置成适配在患者的耳、鼻或喉中的解剖通道中;(b)基板,所述基板沿所述轴的至少一部分延伸;(c)至少一个导电传感器迹线,所述至少一个导电传感器迹线形成在所述基板上,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定至少一个导航传感器;以及(d)处理器,其中所述处理器操作地耦接到所述至少一个导航传感器,其中所述处理器被配置成监测所述至少一个传感器迹线的温度。An apparatus comprising: (a) a shaft assembly having a distal end sized and configured to fit an anatomical passage in the ear, nose, or throat of a patient in; (b) a substrate extending along at least a portion of the axis; (c) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor The trace includes at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and (d) a processor, wherein the processor is operatively coupled to the at least one navigation sensor, wherein the The processor is configured to monitor the temperature of the at least one sensor trace.

实施例57Example 57

一种使用设备的方法,所述设备具有(i)基板和(ii)形成在所述基板上的至少一个导电传感器迹线,其中所述至少一个传感器迹线包括至少一个同心环部分,其中所述至少一个同心环部分限定至少一个导航传感器,所述方法包括:(a)将所述柔性基板插入患者的解剖通道中;(b)将所述至少一个导航传感器暴露于电磁场;(c)响应于将所述至少一个导航传感器暴露于所述电磁场的行为,经由所述至少一个导航传感器生成信号;(d)基于所生成的信号来确定位置坐标;(e)检测所述至少一个传感器迹线的温度变化;以及(f)响应于检测所述至少一个传感器迹线的温度变化的行为来调整所述位置坐标。A method of using a device having (i) a substrate and (ii) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace includes at least one concentric ring portion, wherein the The at least one concentric ring portion defines at least one navigation sensor, and the method includes: (a) inserting the flexible substrate into an anatomical passage of the patient; (b) exposing the at least one navigation sensor to an electromagnetic field; (c) responding generating a signal via the at least one navigation sensor upon the act of exposing the at least one navigation sensor to the electromagnetic field; (d) determining position coordinates based on the generated signal; (e) detecting the at least one sensor trace and (f) adjusting the position coordinates in response to detecting a temperature change of the at least one sensor trace.

实施例58Example 58

根据实施例57所述的方法,其中调整所述位置坐标的行为包括将校正因子应用于所述位置坐标,其中所述校正因子对应于所检测到的温度变化。The method of embodiment 57, wherein the act of adjusting the location coordinates includes applying a correction factor to the location coordinates, wherein the correction factor corresponds to the detected temperature change.

实施例59Example 59

根据实施例57至58中任一项所述的方法,其中经由温度传感器执行检测所述至少一个传感器迹线的温度变化的所述行为。A method as in any one of embodiments 57 to 58, wherein said act of detecting temperature changes of said at least one sensor trace is performed via a temperature sensor.

实施例60Example 60

根据实施例57至58中任一项所述的方法,其中检测所述至少一个传感器迹线的温度变化的所述行为包括检测所述至少一个传感器迹线的电阻抗变化。A method as in any one of embodiments 57-58, wherein the act of detecting a change in temperature of the at least one sensor trace includes detecting a change in electrical impedance of the at least one sensor trace.

实施例61Example 61

一种设备,包括:(a)内轴,所述内轴限定内腔,所述内腔的大小被设置成接纳器械;(b)外轴,所述外轴相对于所述内轴牢固地固定,所述外轴与所述内轴同轴地布置;以及(c)第一导航传感器,所述第一导航传感器径向地插置在所述内轴与所述外轴之间,所述第一导航传感器能够操作以生成指示所述第一导航传感器在三维空间中的位置的信号。An apparatus comprising: (a) an inner shaft defining a lumen sized to receive an instrument; (b) an outer shaft securely positioned relative to the inner shaft fixed, the outer shaft and the inner shaft are arranged coaxially; and (c) a first navigation sensor, the first navigation sensor is radially inserted between the inner shaft and the outer shaft, so The first navigation sensor is operable to generate a signal indicative of a position of the first navigation sensor in three-dimensional space.

实施例62Example 62

根据实施例61所述的设备,所述内腔的大小被设置成接纳组织剃刮器械的轴组件。According to the device of embodiment 61, the inner cavity is sized to receive a shaft assembly of a tissue shaving instrument.

实施例63Example 63

根据实施例62所述的设备,还包括具有轴组件的组织剃刮器械,所述内腔的大小被设置成接纳所述组织剃刮器械的所述轴组件。The apparatus of embodiment 62, further comprising a tissue shaving instrument having a shaft assembly, the lumen being sized to receive the shaft assembly of the tissue shaving instrument.

实施例64Example 64

根据实施例63所述的设备,所述组织剃刮器械的所述轴组件具有被构造成接纳组织的横向开口,所述内轴和所述外轴各自具有一定长度,所述长度的大小被设置成当所述组织剃刮器械的所述轴组件完全插入在所述内腔中时提供所述横向开口的暴露。The apparatus of embodiment 63, the shaft assembly of the tissue shaving instrument having a transverse opening configured to receive tissue, the inner shaft and the outer shaft each having a length, the length being Arranged to provide exposure of the transverse opening when the shaft assembly of the tissue shaving instrument is fully inserted within the lumen.

实施例65Example 65

根据实施例64所述的设备,所述第一导航传感器被构造成用于当所述组织剃刮器械的所述轴组件完全插入所述内腔中时定位在所述横向开口附近和近侧。The apparatus of embodiment 64, the first navigation sensor configured for positioning adjacent and proximal to the lateral opening when the shaft assembly of the tissue shaving instrument is fully inserted into the lumen. .

实施例66Example 66

根据实施例61至65中任一项所述的设备,还包括径向地插置在所述内轴与所述外轴之间的柔性基板,所述第一导航传感器定位在所述柔性基板上作为柔性电路的一部分。The apparatus of any one of embodiments 61 to 65, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor positioned on the flexible substrate as part of a flexible circuit.

实施例67Example 67

根据实施例66所述的设备,所述柔性基板沿所述内轴的长度并且沿所述外轴的长度延伸。The apparatus of embodiment 66, the flexible substrate extends along the length of the inner shaft and along the length of the outer shaft.

实施例68Example 68

根据实施例67所述的设备,所述柔性基板具有远侧端部,所述第一导航传感器定位在所述柔性基板的所述远侧端部处。The apparatus of embodiment 67, the flexible substrate having a distal end, the first navigation sensor being positioned at the distal end of the flexible substrate.

实施例69Example 69

根据实施例61至68中任一项所述的设备,还包括径向地插置在所述内轴与所述外轴之间的第二导航传感器,所述第二导航传感器能够操作以生成指示所述第二导航传感器在三维空间中的位置的信号。The apparatus of any one of embodiments 61 to 68, further comprising a second navigation sensor radially interposed between the inner shaft and the outer shaft, the second navigation sensor operable to generate A signal indicating the position of the second navigation sensor in three-dimensional space.

实施例70Example 70

根据实施例69所述的设备,所述第二导航传感器定位在所述第一导航传感器的近侧。The apparatus of embodiment 69, the second navigation sensor is positioned proximal to the first navigation sensor.

实施例71Example 71

根据实施例69至70中任一项所述的设备,还包括径向地插置在所述内轴与所述外轴之间的柔性基板,所述第一导航传感器和所述第二导航传感器各自定位在所述柔性基板上作为柔性电路的一部分。The apparatus of any one of embodiments 69 to 70, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor and the second navigation sensor Sensors are each positioned on the flexible substrate as part of a flexible circuit.

实施例72Example 72

根据实施例61至71中任一项所述的设备,还包括毂,所述毂定位在所述内轴或所述外轴中的一者或两者的近侧端部处。The device of any one of embodiments 61-71, further comprising a hub positioned at a proximal end of one or both of the inner shaft or the outer shaft.

实施例73Example 73

根据实施例72所述的设备,所述毂被配置成与接纳在所述内腔中的器械可移除地耦接。The device of embodiment 72, the hub is configured to removably couple with an instrument received in the lumen.

实施例74Example 74

根据实施例61至73中任一项所述的设备,所述内轴具有开口远侧端部和开口近侧端部。The device of any one of embodiments 61 to 73, the inner shaft having an open distal end and an open proximal end.

实施例75Example 75

根据实施例61至74中任一项所述的设备,所述外轴具有开口远侧端部和开口近侧端部。The device of any one of embodiments 61 to 74, the outer shaft having an open distal end and an open proximal end.

实施例76Example 76

一种设备,包括:(a)轴组件,所述轴组件包括外轴,所述外轴具有外表面、长度和远侧端部;(b)柔性电路,所述柔性电路包括:(i)柔性基板,所述柔性基板固定到所述外轴的所述外表面,所述柔性基板的至少一部分沿所述外轴的所述长度延伸,以及(ii)多个电极,所述多个电极固定到所述柔性基板,所述电极定位在所述外轴的所述远侧端部处或附近,所述电极能够操作以向组织施加RF能量,从而消融所述组织。An apparatus comprising: (a) a shaft assembly including an outer shaft having an outer surface, a length and a distal end; (b) a flexible circuit including: (i) a flexible substrate secured to the outer surface of the outer shaft, at least a portion of the flexible substrate extending along the length of the outer shaft, and (ii) a plurality of electrodes, the plurality of electrodes Secured to the flexible substrate, the electrode is positioned at or near the distal end of the outer shaft, the electrode operable to apply RF energy to tissue to ablate the tissue.

实施例77Example 77

根据实施例76所述的设备,所述电极布置成沿所述外轴的所述远侧端部延伸的阵列。The device of embodiment 76, the electrodes are arranged in an array extending along the distal end of the outer shaft.

实施例78Example 78

根据实施例76至77中任一项所述的设备,所述电极布置成沿位于所述外轴的所述远侧端部的近侧的区沿所述外轴的所述长度的一部分延伸的阵列。The apparatus of any one of embodiments 76 to 77, said electrode being arranged to extend along a portion of said length of said outer shaft along a region proximal to said distal end of said outer shaft array.

实施例79Example 79

根据实施例76至78中任一项所述的设备,所述外轴限定圆周,所述电极布置成围绕所述外轴的所述圆周延伸的阵列。The apparatus of any one of embodiments 76 to 78, the outer shaft defining a circumference, the electrodes being arranged in an array extending around the circumference of the outer shaft.

实施例80Example 80

根据实施例79所述的设备,所述电极包括两个电极,所述两个电极中的每个电极具有大致半圆形形状。The device of embodiment 79, the electrodes include two electrodes, each of the two electrodes having a generally semicircular shape.

实施例81Example 81

根据实施例79所述的设备,所述电极包括多个正方形或矩形形状的电极。According to the device of embodiment 79, the electrodes include a plurality of square or rectangular shaped electrodes.

实施例82Example 82

根据实施例76至81中任一项所述的设备,所述外轴限定圆周,所述柔性基板包括纵向延伸部分和周向延伸部分,所述纵向延伸部分沿所述外轴的所述长度延伸,所述周向延伸部分围绕所述外轴的所述圆周延伸。The apparatus of any one of embodiments 76 to 81, the outer shaft defining a circumference, the flexible substrate including a longitudinally extending portion and a circumferentially extending portion, the longitudinally extending portion along the length of the outer shaft Extending, the circumferential extension extends around the circumference of the outer shaft.

实施例83Example 83

根据实施例82所述的设备,所述纵向延伸部分具有远侧端部,所述周向延伸部分位于所述纵向延伸部分的所述远侧端部处。The apparatus of embodiment 82, the longitudinally extending portion having a distal end, the circumferentially extending portion being located at the distal end of the longitudinally extending portion.

实施例84Example 84

根据实施例82至83中任一项所述的设备,所述电极中的至少一些电极以周向延伸阵列沿所述周向延伸部分定位。The apparatus of any one of embodiments 82 to 83, at least some of the electrodes being positioned along the circumferentially extending portion in a circumferentially extending array.

实施例85Example 85

根据实施例76至84中任一项所述的设备,所述外轴进一步限定被构造成接纳组织的开口,所述轴组件还包括被构造成切断接纳在所述开口中的组织的切割轴。The device of any one of embodiments 76-84, the outer shaft further defining an opening configured to receive tissue, the shaft assembly further comprising a cutting shaft configured to sever tissue received in the opening. .

实施例86Example 86

根据实施例85所述的设备,所述开口在所述外轴上具有横向取向,使得所述开口的至少一部分沿所述轴纵向地延伸。The apparatus of embodiment 85, the opening having a transverse orientation on the outer axis such that at least a portion of the opening extends longitudinally along the axis.

实施例87Example 87

根据实施例86所述的设备,所述电极中的至少一些电极在所述开口旁边以阵列纵向地延伸。The apparatus of embodiment 86, at least some of the electrodes extend longitudinally in an array beside the opening.

实施例88Example 88

根据实施例85至86中任一项所述的设备,所述电极中的至少一些电极定位在所述开口的近侧。The device of any one of embodiments 85 to 86, at least some of the electrodes are positioned proximal of the opening.

实施例89Example 89

根据实施例85至88中任一项所述的设备,所述电极中的至少一些电极定位在所述开口的远侧。The device of any one of embodiments 85 to 88, at least some of the electrodes are positioned distally of the opening.

VII.杂项VII.Miscellaneous

应当理解,本文所述的教导内容、表达方式、实施方案、实施例等中的任一者可与本文所述的其他教导内容、表达方式、实施方案、实施例等中的任一者进行组合。因此,上述教导内容、表达方式、实施方案、实施例等不应被视为彼此孤立。参考本文的教导内容,本文的教导内容可进行组合的各种合适方式对于本领域的技术人员而言将显而易见。此类修改和变型旨在包括在权利要求书的范围内。It is to be understood that any of the teachings, expressions, embodiments, examples, etc. described herein may be combined with any of the other teachings, expressions, embodiments, examples, etc. described herein . Accordingly, the above teachings, expressions, implementations, examples, etc. should not be considered in isolation from each other. Various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.

上文所述的型式的装置可被设计为单次使用后丢弃,或者它们可被设计为可多次使用。在任一种情况下或两种情况下,可对这些型式进行修复以在至少一次使用之后重复使用。修复可包括以下步骤的任意组合:拆卸装置,然后清洁或替换特定零件以及随后进行重新组装。具体地,可拆卸一些型式的装置,并且可以任何组合来选择性地替换或移除装置的任意数量的特定零件或部分。在清洁和/或更换特定部件时,一些型式的装置可在修复设施处重新组装或者在即将进行规程之前由用户重新组装以供随后使用。本领域的技术人员将会了解,装置的修复可利用多种技术进行拆卸、清洁/更换、以及重新组装。此类技术的使用以及所得的修复装置均在本申请的范围内。Devices of the type described above may be designed for single use and then discarded, or they may be designed for multiple uses. In either or both cases, these versions can be repaired for reuse after at least one use. Restoration can include any combination of the following steps: disassembly of the unit, followed by cleaning or replacement of specific parts and subsequent reassembly. In particular, some types of devices may be disassembled, and any number of specific parts or portions of the device may be selectively replaced or removed in any combination. When certain parts are cleaned and/or replaced, some types of devices may be reassembled at a reconditioning facility or by the user immediately prior to the procedure for subsequent use. Those skilled in the art will appreciate that device repair may utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques and the resulting repair devices are within the scope of this application.

仅以举例的方式,本文描述的型式可在规程之前和/或之后消毒。在一种消毒技术中,将所述装置放置在闭合且密封的容器诸如塑料袋或TYVEK袋中。然后可将容器和装置放置在可穿透容器的辐射场中,诸如γ辐射、x射线、或高能电子。辐射可杀死装置上和容器中的细菌。然后可将经消毒的装置储存在无菌容器中,以供以后使用。还可使用本领域已知的任何其它技术对装置进行消毒,该技术包括但不限于β辐射或γ辐射、环氧乙烷或蒸汽。By way of example only, the versions described herein may be sterilized before and/or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or TYVEK bag. The container and device can then be placed in a radiation field that penetrates the container, such as gamma radiation, x-rays, or high-energy electrons. Radiation kills bacteria on the device and in the container. The sterilized device can then be stored in a sterile container for later use. The device may also be sterilized using any other technique known in the art, including but not limited to beta or gamma radiation, ethylene oxide, or steam.

已经示出和阐述了本发明的各种实施方案,可在不脱离本发明的范围的情况下由本领域的普通技术人员进行适当修改来实现本文所述的方法和系统的进一步改进。已经提及了若干此类可能的修改,并且其他修改对于本领域的技术人员而言将显而易见。例如,上文所讨论的实施例、实施方案、几何形态、材料、尺寸、比率、步骤等均是例示性的而非必需的。因此,本发明的范围应根据以下权利要求书来考虑,并且应理解为不限于说明书和附图中示出和描述的结构和操作的细节。Having shown and described various embodiments of the invention, further improvements in the methods and systems described herein may be effected by those of ordinary skill in the art with appropriate modifications without departing from the scope of the invention. Several such possible modifications have been mentioned, and others will be apparent to those skilled in the art. For example, the examples, implementations, geometries, materials, dimensions, ratios, steps, etc. discussed above are illustrative and not required. Accordingly, the scope of the invention should be considered in light of the following claims, and should be understood not to be limited to the details of construction and operation shown and described in the specification and drawings.

Claims (89)

1. An ENT surgical instrument, comprising:
(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;
(b) A flexible substrate extending along at least a portion of the shaft; and
(c) At least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor.
2. The ENT surgical instrument of claim 1, wherein the at least one navigation sensor comprises a proximal navigation sensor and at least one distal navigation sensor.
3. The ENT surgical instrument of claim 2, wherein the at least one distal navigation sensor comprises a pair of laterally adjacent distal navigation sensors.
4. The ENT surgical instrument of any one of claims 2-3, wherein the proximal and distal navigation sensors are electrically isolated from each other.
5. The ENT surgical instrument of any one of claims 1-4, wherein the flexible substrate comprises a top surface and a bottom surface, wherein the at least one navigation sensor comprises a top navigation sensor positioned on the top surface and a bottom navigation sensor positioned on the bottom surface opposite the top navigation sensor.
6. The ENT surgical instrument of claim 5, wherein the top navigation sensor and the bottom navigation sensor are electrically coupled to each other.
7. The ENT surgical instrument of any one of claims 1-6, further comprising at least one sensor lead electrically coupled to a proximal end of the at least one sensor trace, wherein the at least one sensor lead is configured to be operatively coupled to a processor.
8. The ENT surgical instrument of claim 7, wherein the at least one sensor lead is positioned proximally relative to the at least one navigation sensor.
9. The ENT surgical instrument of any one of claims 1-8, wherein the flexible substrate is at least one of rectangular or serpentine.
10. The ENT surgical instrument of any one of claims 1-9, wherein the flexible substrate is configured to transition between a flat configuration and at least one curved configuration.
11. The ENT surgical instrument of any one of claims 1-10, the shaft assembly comprising a shaft member, wherein the flexible substrate is secured to the shaft member.
12. The ENT surgical instrument of claim 11, wherein the shaft member comprises an inner chord, wherein the flexible substrate is disposed along the inner chord in a flat configuration.
13. The ENT surgical instrument of claim 11, wherein the shaft member comprises a cylindrical inner surface, wherein the flexible substrate is disposed along the cylindrical inner surface in at least one curved configuration.
14. The ENT surgical instrument of claim 11, wherein the shaft member comprises a cylindrical outer surface, wherein the flexible substrate is disposed along the cylindrical outer surface in at least one curved configuration.
15. The ENT surgical instrument of any one of claims 1-14, wherein the shaft assembly comprises a flexible portion, wherein the flexible substrate extends along the flexible portion.
16. An ENT surgical instrument, comprising:
(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;
(b) A flexible substrate extending along at least a portion of the shaft, the flexible substrate having a top surface and a bottom surface;
(c) A proximal top conductive sensor trace formed on the top surface, wherein the proximal top sensor trace comprises a proximal top concentric ring portion, wherein the proximal top concentric ring portion defines a proximal top navigation sensor;
(d) At least one distal top conductive sensor trace formed on the top surface, wherein the at least one distal top sensor trace comprises at least one distal top concentric ring portion, wherein the at least one distal top concentric ring portion defines at least one distal top navigation sensor;
(e) A proximal bottom conductive sensor trace formed on the bottom surface, wherein the proximal bottom sensor trace comprises a proximal bottom concentric ring portion, wherein the proximal bottom concentric ring portion defines a proximal bottom navigation sensor; and
(f) At least one distal bottom conductive sensor trace formed on the bottom surface, wherein the at least one distal bottom sensor trace comprises at least one distal bottom concentric ring portion, wherein the at least one distal bottom concentric ring portion defines at least one distal bottom navigation sensor.
17. The ENT surgical instrument of claim 16, wherein the proximal bottom sensor trace is positioned opposite the proximal top sensor trace, wherein the at least one distal bottom sensor trace is positioned opposite the at least one distal top sensor trace.
18. The ENT surgical instrument of any one of claims 16-17, wherein the at least one distal top sensor trace comprises a pair of laterally adjacent distal top sensor traces, wherein the at least one distal bottom sensor trace comprises a pair of laterally adjacent distal bottom sensor traces.
19. A method of using an ENT surgical instrument having (i) a flexible substrate and (ii) at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising:
(a) Inserting the flexible substrate into an anatomical passageway within at least one of an ear, nose, or throat of a patient;
(b) Exposing the at least one navigation sensor to an electromagnetic field;
(c) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;
(d) Navigating a distal portion of the ENT surgical instrument through the anatomic passageway based on the generated signals; and
(e) The anatomic passageway is treated via the ENT surgical instrument.
20. The method of claim 19, wherein the act of treating the anatomical passageway via the ENT surgical instrument comprises at least one of: expanding the anatomic passageways, applying RF energy to tissue within the anatomic passageways, severing tissue within the anatomic passageways, or removing debris from the anatomic passageways.
21. An apparatus, comprising:
(a) A shaft assembly having a distal end sized and configured to fit in an anatomic passageway in a patient's ear, nose, or throat;
(b) A flexible substrate extending along at least a portion of the shaft;
(c) At least one navigation sensor positioned on the flexible substrate; and
(d) At least one conductive camera trace formed on the flexible substrate, wherein the at least one camera trace is configured to operatively couple a camera to at least one of a processor or a power source.
22. The apparatus of claim 21, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.
23. The apparatus of any one of claims 21 to 22, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.
24. The apparatus of any of claims 21-23, wherein the flexible substrate comprises a top surface and a bottom surface, wherein the at least one navigation sensor comprises a top navigation sensor positioned on the top surface and a bottom navigation sensor positioned on the bottom surface opposite the top navigation sensor.
25. The apparatus of any of claims 21-24, wherein the flexible substrate comprises a surface, wherein the at least one navigation sensor is positioned on the surface, wherein the at least one camera trace is formed on the surface.
26. The apparatus of any of claims 21-25, further comprising at least one proximal camera lead electrically coupled to a proximal end of the at least one camera trace, wherein the at least one proximal camera lead is configured to be operatively coupled to at least one of a processor or a power source.
27. The apparatus of claim 26, wherein the at least one proximal camera lead is positioned proximally relative to the at least one navigation sensor.
28. The device of any of claims 21-27, further comprising at least one distal camera lead electrically coupled to a distal end of the at least one camera trace, wherein the at least one distal camera lead is configured to be operatively coupled to the camera.
29. The apparatus of claim 28, wherein the at least one distal camera lead is positioned distally relative to the at least one navigation sensor.
30. The apparatus of any of claims 21 to 29, wherein the at least one camera trace comprises a plurality of camera traces.
31. The apparatus of claim 30, wherein the plurality of camera traces are laterally located to a side of the at least one navigation sensor.
32. The device of any of claims 21 to 31, further comprising the camera, wherein the at least one camera trace is operatively coupled to the camera.
33. The apparatus of any one of claims 21 to 32, further comprising at least one of the processor or the power source, wherein the at least one camera trace is operatively coupled to the at least one of the processor or the power source.
34. The apparatus of any one of claims 21 to 33, the shaft assembly comprising a flexible portion, the flexible substrate being secured to the flexible portion, the flexible substrate being further configured to flex with the flexible portion.
35. The apparatus of any one of claims 21 to 34, the shaft assembly comprising one or more electrodes operable to apply RF energy to tissue.
36. An apparatus, comprising:
(a) A camera;
(b) A processor;
(c) A power source;
(d) A flexible substrate;
(e) At least one navigation sensor positioned on the flexible substrate; and
(f) A first conductive camera trace and a second conductive camera trace, the first conductive camera trace and the second conductive camera trace being formed on the flexible substrate,
wherein the first camera trace operatively couples the camera to the processor, wherein the second camera trace operatively couples the camera to the power source.
37. The apparatus of claim 36, further comprising at least one conductive sensor trace formed on the flexible substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines the at least one navigation sensor.
38. A method of using a device having (i) a flexible substrate, (ii) at least one navigation sensor positioned on the flexible substrate, and (iii) at least one conductive camera trace formed on the flexible substrate, the method comprising:
(a) Operatively coupling a camera to at least one of a processor or a power source via the at least one camera trace;
(b) Inserting the flexible substrate into an anatomic passageway of a patient;
(c) Exposing the at least one navigation sensor to an electromagnetic field;
(d) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;
(e) Navigating a distal portion of the device through the anatomic passageway based on the generated signals; and
(f) A portion of the anatomic passageway distal to the distal portion of the device is visualized via the camera.
39. The method of claim 38, wherein the act of navigating the distal portion of the device through the anatomic passageway comprises bending the flexible substrate.
40. The method of any one of claims 38 to 39, further comprising applying RF energy to tissue within the anatomic passageway.
41. An apparatus, comprising:
(a) A shaft assembly having a distal end sized and configured to fit within a patient's ear In an anatomic passageway in the nose or throat;
(b) A base plate positioned along at least a portion of the axis;
(c) At least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and
(d) At least one temperature sensor positioned on the substrate.
42. The apparatus of claim 41, wherein the at least one temperature sensor is configured to detect a temperature of the at least one sensor trace.
43. The apparatus of claim 42, wherein the at least one temperature sensor comprises at least one of a thermocouple or a thermistor.
44. The device of any one of claims 42 to 43, further comprising a processor, wherein the processor is operatively coupled to the at least one navigation sensor and the at least one temperature sensor such that the at least one navigation sensor is operable to communicate a position signal to the processor and such that the at least one temperature sensor is operable to communicate a temperature signal to the processor.
45. The apparatus of claim 44, wherein the processor is configured to determine location coordinates based on the location signals transmitted to the processor by the at least one navigation sensor and based on the temperature signals transmitted to the processor by the at least one temperature sensor.
46. The apparatus of claim 45, wherein the processor is configured to apply a correction factor to the position coordinates in response to the temperature signal indicating a change in the detected temperature.
47. The device of any one of claims 45 to 46, wherein the processor is configured to correlate the detected change in temperature with a change in resistance of the at least one sensor trace.
48. The apparatus of any one of claims 41-47, wherein the substrate comprises a surface, wherein the at least one navigation sensor is positioned on the surface, wherein the at least one temperature sensor is positioned on the surface.
49. The apparatus of any one of claims 41-48, wherein the substrate is flexible.
50. The device of any one of claims 41-49, wherein the at least one navigation sensor comprises a proximal navigation sensor and a distal navigation sensor.
51. The apparatus of claim 50, wherein the at least one temperature sensor comprises at least one proximal temperature sensor positioned near the proximal navigation sensor and at least one distal temperature sensor positioned near the distal navigation sensor.
52. The apparatus of claim 51, wherein the at least one proximal temperature sensor is positioned proximally relative to the proximal navigation sensor, wherein the at least one distal temperature sensor is positioned proximally relative to the distal navigation sensor and distally relative to the proximal navigation sensor.
53. The apparatus of any one of claims 41-52, wherein the at least one temperature sensor comprises a pair of laterally adjacent temperature sensors.
54. An ENT surgical instrument, comprising:
(a) A power component configured to generate heat; and
(b) The apparatus of any one of claims 41-53, wherein the at least one navigation sensor is exposed to heat generated by the power component.
55. The ENT surgical instrument of claim 54, wherein the power component comprises at least one of (i) an electrode configured to deliver RF energy to tissue, or (ii) a motor configured to drive a cutting member for severing tissue.
56. An apparatus, comprising:
(a) A shaft assembly having a distal end sized and configured to fit within a patient's ear In an anatomic passageway in the nose or throat;
(b) A substrate extending along at least a portion of the axis;
(c) At least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor; and
(d) The processor may be configured to perform the steps of,
wherein the processor is operatively coupled to the at least one navigation sensor, wherein the processor is configured to monitor a temperature of the at least one sensor trace.
57. A method of using a device having (i) a substrate and (ii) at least one conductive sensor trace formed on the substrate, wherein the at least one sensor trace comprises at least one concentric ring portion, wherein the at least one concentric ring portion defines at least one navigation sensor, the method comprising:
(a) Inserting the flexible substrate into an anatomic passageway of a patient;
(b) Exposing the at least one navigation sensor to an electromagnetic field;
(c) Generating a signal via the at least one navigation sensor in response to the act of exposing the at least one navigation sensor to the electromagnetic field;
(d) Determining location coordinates based on the generated signals;
(e) Detecting a temperature change of the at least one sensor trace; and
(f) The position coordinates are adjusted in response to a behavior of detecting a temperature change of the at least one sensor trace.
58. The method of claim 57, wherein the act of adjusting the position coordinates comprises applying a correction factor to the position coordinates, wherein the correction factor corresponds to the detected temperature change.
59. The method of any of claims 57-58, wherein the act of detecting a temperature change of the at least one sensor trace is performed via a temperature sensor.
60. The method of any of claims 57-58 wherein the act of detecting a temperature change of the at least one sensor trace includes detecting a change in electrical impedance of the at least one sensor trace.
61. An apparatus, comprising:
(a) An inner shaft defining a lumen sized to receive an instrument;
(b) An outer shaft fixedly secured relative to the inner shaft, the outer shaft being coaxially disposed with the inner shaft; and
(c) A first navigation sensor interposed radially between the inner shaft and the outer shaft, the first navigation sensor operable to generate a signal indicative of a position of the first navigation sensor in three-dimensional space.
62. The apparatus of claim 61, the lumen sized to receive a shaft assembly of a tissue shaving instrument.
63. The apparatus of claim 62, further comprising a tissue shaving instrument having a shaft assembly, the lumen sized to receive the shaft assembly of the tissue shaving instrument.
64. The apparatus of claim 63, the shaft assembly of the tissue shaving instrument having a transverse opening configured to receive tissue, the inner shaft and the outer shaft each having a length sized to provide exposure of the transverse opening when the shaft assembly of the tissue shaving instrument is fully inserted in the lumen.
65. The apparatus of claim 64, the first navigation sensor configured for positioning near and proximal to the lateral opening when the shaft assembly of the tissue shaving instrument is fully inserted into the lumen.
66. The apparatus of any one of claims 61-65, further comprising a flexible substrate radially interposed between the inner shaft and the outer shaft, the first navigation sensor positioned on the flexible substrate as part of a flexible circuit.
67. The apparatus of claim 66, the flexible substrate extending along a length of the inner shaft and along a length of the outer shaft.
68. The apparatus of claim 67, the flexible substrate having a distal end, the first navigation sensor positioned at the distal end of the flexible substrate.
69. The apparatus of any one of claims 61-68, further comprising a second navigation sensor radially interposed between the inner shaft and the outer shaft, the second navigation sensor operable to generate a signal indicative of a position of the second navigation sensor in three-dimensional space.
70. The apparatus of claim 69, the second navigation sensor positioned proximal to the first navigation sensor.
71. The apparatus of any one of claims 69-70, further comprising a flexible substrate interposed radially between the inner shaft and the outer shaft, the first and second navigation sensors each positioned on the flexible substrate as part of a flexible circuit.
72. The apparatus of any one of claims 61-71, further comprising a hub positioned at a proximal end of one or both of the inner shaft or the outer shaft.
73. The apparatus of claim 72, the hub configured to be removably coupled with an instrument received in the lumen.
74. The device of any one of claims 61-73, the inner shaft having an open distal end and an open proximal end.
75. The device of any one of claims 61-74, the outer shaft having an open distal end and an open proximal end.
76. An apparatus, comprising:
(a) A shaft assembly including an outer shaft having an outer surface A length and a distal end; and
(b) A flexible circuit, the flexible circuit comprising:
(i) A flexible substrate secured to the outer surface of the outer shaft, at least a portion of the flexible substrate extending along the length of the outer shaft, and
(ii) A plurality of electrodes secured to the flexible substrate, the electrodes positioned at or near the distal end of the outer shaft, the electrodes operable to apply RF energy to tissue to ablate the tissue.
77. The apparatus of claim 76, the electrodes arranged in an array extending along the distal end of the outer shaft.
78. The device of any one of claims 76-77, the electrodes arranged in an array extending along a portion of the length of the outer shaft along a region proximal to the distal end of the outer shaft.
79. The device of any one of claims 76-78, the outer shaft defining a circumference, the electrodes being arranged in an array extending around the circumference of the outer shaft.
80. The apparatus of claim 79, the electrode comprising two electrodes, each of the two electrodes having a generally semi-circular shape.
81. The apparatus of claim 79, the electrode comprising a plurality of square or rectangular shaped electrodes.
82. The apparatus of any one of claims 76-81, the outer shaft defining a circumference, the flexible substrate including a longitudinally extending portion extending along the length of the outer shaft and a circumferentially extending portion extending around the circumference of the outer shaft.
83. The apparatus of claim 82, the longitudinally extending portion having a distal end, the circumferentially extending portion being located at the distal end of the longitudinally extending portion.
84. The apparatus of any one of claims 82-83, at least some of the electrodes being positioned along the circumferentially extending portion in a circumferentially extending array.
85. The device of any one of claims 76-84, the outer shaft further defining an opening configured to receive tissue, the shaft assembly further comprising a cutting shaft configured to sever tissue received in the opening.
86. The apparatus of claim 85, the opening having a transverse orientation on the outer shaft such that at least a portion of the opening extends longitudinally along the shaft.
87. The apparatus of claim 86, at least some of the electrodes extending longitudinally in an array alongside the opening.
88. The device of any one of claims 85-86, at least some of the electrodes being positioned proximal to the opening.
89. The device of any one of claims 85-88, at least some of the electrodes being positioned distal to the opening.
CN202280029241.1A 2021-02-18 2022-02-18 Flexible sensor assembly for ENT instrument Pending CN117202864A (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US63/150776 2021-02-18
US63/288014 2021-12-10
US17/584,693 US20220257093A1 (en) 2021-02-18 2022-01-26 Flexible sensor assembly for ent instrument
US17/584693 2022-01-26
PCT/IB2022/051442 WO2022175877A2 (en) 2021-02-18 2022-02-18 Flexible sensor assembly for ent instrument

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