相关申请的交叉引用Cross References to Related Applications
本申请是2013年7月3日提交并且标题为“用于术中刺激的系统与方法”的共同待决美国专利申请序列No.13/934384的继续部分，美国专利申请序列No.13/934384是2012年9月20日提交并且标题为“用于术中刺激的系统与方法”的共同待决美国专利申请序列No.13/466,485的继续，美国专利申请序列No.13/466,485其是2011年1月26日提交并且标题为“用于术中间刺激的系统与方法”的共同待决美国专利申请序列No.13/014,452的继续部分，美国专利申请序列No.13/014,452是2007年1月9日提交并且标题为“用于术中刺激的系统与方法”的共同待决美国专利申请序列No.11/651,165的继续，美国专利申请序列No.11/651,165是2005年4月6日提交并且标题为“用于术中刺激的系统与方法”的美国专利申请序列No.11/099,848的继续部分，美国专利申请序列No.11/099,848要求2005年3月1日提交并且标题为“用于术中刺激的系统与方法”的美国临时专利申请序列No.60/657,277的优先权，并且本申请还是2006年1月23日提交并且标题为“用于区分和/或识别由目标神经支配的组织区域以便诊断和/或治疗目的的系统与方法”的共同待决美国专利申请序列No.11/337,319的继续部分，其全部通过它们整体引用的方式包含于此。This application is a continuation-in-part of co-pending U.S. Patent Application Serial No. 13/934384, filed July 3, 2013 and entitled "System and Method for Intraoperative Stimulation," U.S. Patent Application Serial No. 13/934384 is a continuation of co-pending U.S. Patent Application Serial No. 13/466,485 filed September 20, 2012 and entitled "System and Method for Intraoperative Stimulation," which was issued in 2011 Continuation-in-Part of co-pending U.S. Patent Application Serial No. 13/014,452 filed January 26, 2007 and entitled "System and Method for Interoperative Stimulation," which was filed on January 2007 Continuation of co-pending U.S. Patent Application Serial No. 11/651,165 filed April 9 and entitled "System and Method for Intraoperative Stimulation," which was filed April 6, 2005 Continuation-in-Part of U.S. Patent Application Serial No. 11/099,848 filed March 1, 2005 and entitled "System and Method for Intraoperative Stimulation" System and Method for Intraoperative Stimulation" is the priority of U.S. Provisional Patent Application Serial No. 60/657,277, and this application was also filed on January 23, 2006 and is entitled "For differentiating and/or identifying System and Method for Dominating a Region of Tissue for Diagnostic and/or Therapeutic Purposes," in continuation of co-pending US Patent Application Serial No. 11/337,319, which are hereby incorporated by reference in their entirety.
技术领域technical field
本发明大体上涉及组织识别与整体性测试，并且更具体地说涉及用于在外科手术过程中保护神经与肌肉免受损伤的系统与方法，神经与肌肉的定位与刺激，在外创损伤以后的神经与肌肉整体性的识别与评估，以及在再造外科手术过程中运动范围与肌肉收缩属性的证实。The present invention relates generally to tissue identification and integrity testing, and more particularly to systems and methods for protecting nerves and muscles from injury during surgical procedures, localization and stimulation of nerves and muscles, following traumatic injury Identification and assessment of neural and muscular integrity, and demonstration of range of motion and muscle contraction properties during reconstructive surgery.
背景技术Background technique
即使利用当今复杂的医疗装置，外科手术也不是无风险的。每个患者的解剖都不同，要求外科医生对这些区别随时保持警惕从而实现期望的结果。神经与其它组织在人类或动物身体内的定位是内部解剖如何在病人与病人之间不同的一个实例。尽管这些差别可能是细微的，但是如果外科医生不能适当地识别一个或几个神经，那么此神经就可能在手术过程中擦伤、伸展、甚至被切断。神经损伤的负面影响范围可以从在身体的此部分上缺少感觉到肌肉控制的丧失。Even with today's sophisticated medical devices, surgery is not without risk. Every patient's anatomy is different, requiring the surgeon to be constantly vigilant about these differences in order to achieve the desired result. The location of nerves and other tissues within the human or animal body is one example of how internal anatomy differs from patient to patient. Although these differences may be subtle, if the surgeon fails to properly identify one or a few nerves, the nerves may be bruised, stretched, or even severed during surgery. Negative effects of nerve damage can range from loss of sensory muscle control on this part of the body.
外伤通常要求外科手术修复。利用视觉检查确定肌肉与神经损伤的范围并不总是可能的。术中刺激器的使用使得能够准确评估在此区域中的神经肌肉系统。此评估提供了在外创损伤以后并且在执行多种外科手术时对引导修复/再造手术有价值的知识。Trauma usually requires surgical repair. It is not always possible to determine the extent of muscle and nerve damage by visual inspection. The use of intraoperative stimulators enables accurate assessment of the neuromuscular system in this area. This assessment provides valuable knowledge to guide repair/reconstructive procedures after traumatic injury and when performing various surgical procedures.
可能期望的是，出于诊断和/或治疗原因，在组织区域内区分和/或识别目标交感神经和/或副交感神经的存在。此外，可能期望的是，瞄准特定神经与组织区域并且限定刺激到目标区域。It may be desirable to differentiate and/or identify the presence of target sympathetic and/or parasympathetic nerves within a tissue region for diagnostic and/or therapeutic reasons. Additionally, it may be desirable to target specific nerve and tissue regions and limit stimulation to the targeted region.
发明内容Contents of the invention
本发明提供了用于术中刺激的装置、系统与方法，其使得能够准确评估神经肌肉系统以引导修复或再构造外科手术。The present invention provides devices, systems and methods for intraoperative stimulation that enable accurate assessment of the neuromuscular system to guide repair or reconstructive surgery.
本发明的一个方面提供了装置、系统与方法，其包括组织刺激系统，此组织刺激系统包括:具有近端与远端的壳体；具有尺寸设计并且构造为用于目标组织区域的电刺激的导电表面的操作元件；并且操作元件从壳体的近端延伸。壳体近端可以包括操作元件调节部分以允许操作元件的移动，使得电刺激以具有用于提供第一指示的幅度与持续时间的刺激信号的形式。刺激控制装置电联接到操作元件，此刺激控制装置包括电源与刺激信号发生电路。组织刺激系统可以符合IPX1水侵入标准。One aspect of the present invention provides devices, systems, and methods that include a tissue stimulation system comprising: a housing having a proximal end and a distal end; a housing sized and configured for electrical stimulation of a target tissue region; an operative element of the conductive surface; and the operative element extends from the proximal end of the housing. The proximal end of the housing may include an operative element adjustment portion to allow movement of the operative element such that the electrical stimulation is in the form of a stimulation signal having an amplitude and duration for providing the first indication. The stimulus control device is electrically coupled to the operating element, and the stimulus control device includes a power supply and a stimulus signal generating circuit. The tissue stimulation system can meet IPX1 water intrusion standards.
在本发明的一个方面中，刺激控制装置定位在壳体内。壳体可以包括夹紧基部部分与操作元件调节部分。操作元件调节部分包括柔性鼻锥。In one aspect of the invention, the stimulus control device is positioned within the housing. The housing may include a clamping base portion and an operating element adjustment portion. The operating element adjustment section includes a flexible nose cone.
第一指示包括定位在壳体上的视觉指示，并且壳体可以是管状的。视觉指示还可以包括反射元件。视觉指示可以包括照明周边环形指示器，此照明周边环形指示器在管状壳体的周边周围是可见的。The first indication includes a visual indication positioned on the housing, and the housing may be tubular. Visual indicators may also include reflective elements. The visual indication may include an illuminated perimeter ring indicator visible around the perimeter of the tubular housing.
本发明的又一个方面提供了装置、系统与方法，其包括组织刺激系统，此组织刺激系统包括具有近端与远端的壳体，诸如管状壳体；操作元件，其具有尺寸设计并且构造为用于目标组织区域的电刺激的导电表面，操作元件从壳体的近端延伸，并且其中，电刺激是以具有幅度与持续时间的信号的形式以提供第一指示给紧邻到目标组织区域的操作元件的使用者；以及电联接到操作元件的刺激控制装置，此刺激控制装置包括刺激信号发生电路。壳体可以包括第一控制装置用于将到操作元件的刺激信号打开与关闭以及用于提供刺激信号幅度的调节，第一控制装置电联接到刺激控制装置。壳体还可以包括用于提供刺激信号持续时间的调节的第二控制装置，此第二控制装置电联接到刺激控制装置。Still another aspect of the present invention provides devices, systems and methods comprising a tissue stimulation system comprising a housing having a proximal end and a distal end, such as a tubular housing; an operative element dimensioned and configured to an electrically conductive surface for electrical stimulation of a target tissue region, the operative element extending from a proximal end of the housing, and wherein the electrical stimulation is in the form of a signal having an amplitude and duration to provide a first indication to a tissue immediately adjacent to the target tissue region a user of the operating element; and a stimulus control device electrically coupled to the operating element, the stimulus control device including a stimulus signal generating circuit. The housing may comprise first control means for switching stimulation signals to the operative element on and off and for providing adjustment of stimulation signal amplitudes, the first control means being electrically coupled to the stimulation control means. The housing may also include a second control device for providing adjustment of the duration of the stimulation signal, the second control device being electrically coupled to the stimulation control device.
本发明的其它方面提供了例如可以利用环氧乙烷消毒的组织刺激系统，并且预先包装以便单次使用。组织刺激系统的刺激信号包括范围可以在大约零毫安与大约20毫安之间范围的幅度，以允许肌肉与神经的准确选择性刺激，以及此外神经与肌肉的识别，肌肉附着，或者收缩肌肉以评估外科手术的质量。组织刺激信号持续时间可以例如包括大约零微秒与大约200微秒之间的范围。通过组织刺激系统提供的第一指示可以包括例如声音与视觉指示。组织刺激系统还可以包括第二指示装置以将电源打开的确认提供到装置并且将刺激信号传送到导电表面。第一指示装置与第二指示装置可以结合在单个指示装置中。组织刺激系统的操作元件例如可以包括探针，其中探针的导电表面包括在探针的近端的大约1毫米与大约10毫米之间，并且探针包括大约0.5毫米与大约1.5毫米之间的直径。组织刺激系统此外还可以包括电联接到刺激控制装置的返回电极。Other aspects of the invention provide tissue stimulation systems that can be sterilized, eg, with ethylene oxide, and are prepackaged for single use. The stimulation signal of the tissue stimulation system includes an amplitude that may range between about zero milliamps and about 20 milliamps to allow for accurate selective stimulation of muscles and nerves, and in addition nerve-to-muscle identification, muscle attachment, or contraction of muscles to Assess the quality of surgical procedures. The tissue stimulation signal duration may, for example, comprise a range between about zero microseconds and about 200 microseconds. The first indication provided by the tissue stimulation system may include, for example, audio and visual indications. The tissue stimulation system may also include a second indicator device to provide confirmation of power on to the device and to transmit a stimulation signal to the conductive surface. The first indicating means and the second indicating means may be combined in a single indicating means. The operative element of the tissue stimulation system may include, for example, a probe, wherein the conductive surface of the probe is comprised between about 1 millimeter and about 10 millimeters of the proximal end of the probe, and the probe comprises between about 0.5 millimeters and about 1.5 millimeters. diameter. The tissue stimulation system may additionally include a return electrode electrically coupled to the stimulation control device.
本发明的其它方面提供了组织刺激系统，诸如医疗装置，其包括：具有近端与远端的壳体，壳体的尺寸设计并且构造为通过使用者保持在左手或右手中；探针，其具有尺寸设计并且构造为用于目标组织区域的电刺激的导电表面，此探针从壳体的近端延伸。壳体近端可以包括探针调节部分以允许探针的移动。电刺激以信号的形式，此信号具有幅度与持续时间以便提供物理运动反应，刺激控制装置电联接到探针并且尺寸设计并且构造为定位在壳体内，此刺激控制装置包括刺激信号生成电路。壳体可以包括用于将到探针的刺激信号打开与关闭并且用于提供刺激信号幅度的调节的第一控制装置，此第一控制装置电联接到刺激控制装置。壳体还可以包括用于提供刺激信号持续时间的调节的第二控制装置，此第二控制装置电联接到刺激控制装置。Other aspects of the invention provide a tissue stimulation system, such as a medical device, comprising: a housing having a proximal end and a distal end, the housing is sized and configured to be held by a user in either the left or right hand; Extending from the proximal end of the housing is a probe having a conductive surface sized and configured for electrical stimulation of a target tissue region. The proximal end of the housing may include a stylet adjustment portion to allow movement of the stylet. The electrical stimulation is in the form of a signal having an amplitude and duration to provide a physical motor response. A stimulation control device is electrically coupled to the probe and is sized and configured to be positioned within the housing. The stimulation control device includes a stimulation signal generating circuit. The housing may include first control means for switching stimulation signals to the probe on and off and for providing adjustment of stimulation signal amplitudes, the first control means being electrically coupled to the stimulation control means. The housing may also include a second control device for providing adjustment of the duration of the stimulation signal, the second control device being electrically coupled to the stimulation control device.
根据本发明的另一个方面，刺激控制装置电联接到至少一个外科手术工具，该外壳手术工具可以包括例如切割、夹紧、钻孔、旋拧、和/或观察工具。当外科手术工具紧邻可行神经或肌肉组织时，将刺激电压或电流施加到此装置允许临床医生观察在神经系统反应中的肌肉收缩或改变。外科手术工具由此成为神经/肌肉刺激电极。在使用中，与不同医学手术关联而单独地部署的不同的外科手术工具可以利用选定的外科手术工具可以临时地联接至其以便使用的单个刺激控制装置。According to another aspect of the invention, the stimulation control device is electrically coupled to at least one surgical tool, which may include, for example, cutting, clamping, drilling, screwing, and/or viewing tools. Applying a stimulating voltage or current to the device allows the clinician to observe muscle contractions or changes in nervous system response when the surgical tool is in close proximity to viable nerve or muscle tissue. The surgical tool thus becomes a nerve/muscle stimulating electrode. In use, different surgical tools deployed separately in association with different medical procedures may utilize a single stimulation control device to which a selected surgical tool may be temporarily coupled for use.
根据本发明的另一个方面，刺激控制装置可以嵌入在外科手术工具内以提供如上所述的能够提供刺激的医疗装置。According to another aspect of the invention, a stimulation control device may be embedded within a surgical tool to provide a medical device capable of providing stimulation as described above.
本发明的另一个方面提供了包括刺激监控器或探针与至少一个电极的装置、系统与方法。在一个实施方式中，手持刺激探针或监控器包括刺激控制装置与同一标准壳体内的至少一个刺激电极以提供符合人体工程学的刺激装置。手持刺激探针可以是用于在外科手术过程中使用的无菌、单次使用装置以识别神经与肌肉、肌肉附接，或者收缩肌肉以评估外科手术的质量或者对外科手术的需要，或者估计已经通过视觉或听觉装置或者通过其它神经系统监控装置识别的神经的功能。Another aspect of the invention provides devices, systems and methods comprising a stimulation monitor or probe and at least one electrode. In one embodiment, a handheld stimulation probe or monitor includes a stimulation control device and at least one stimulation electrode in the same standard housing to provide an ergonomic stimulation device. The hand-held stimulating probe may be a sterile, single-use device for use during surgical procedures to identify nerves to muscles, muscle attachments, or to contract muscles to assess the quality of surgery or the need for surgery, or to estimate The function of nerves that have been identified by visual or auditory devices or by other nervous system monitoring devices.
本发明的又一个方面提供了装置、系统、与方法，包括测试患者的组织区域的方法，该方法包括提供具有从壳体的近端延伸的操作元件的组织刺激系统,壳体近端可以包括操作元件调节部分以允许操作元件的移动；将第一控制装置移动到致动位置,致使通过刺激系统产生刺激信号并且将刺激信号传送到操作元件；使患者与操作元件在目标组织区域处接合；以及观察目标组织区域以用于第一指示。Yet another aspect of the present invention provides devices, systems, and methods, including methods of testing a tissue region of a patient, the method comprising providing a tissue stimulation system having an operative element extending from a proximal end of a housing, which may include the operative element adjusts the portion to allow movement of the operative element; moves the first control device to an actuated position, causing a stimulation signal to be generated by the stimulation system and transmitted to the operative element; engaging the patient with the operative element at the target tissue region; And observing the target tissue region for the first indication.
此方法还可以包括使患者与电联接到刺激系统的第二电极接合，第二电极允许刺激信号从操作元件流动，通过患者的身体到第二电极，并且返回到刺激系统。The method may also include engaging the patient with a second electrode electrically coupled to the stimulation system, the second electrode allowing a stimulation signal to flow from the operative element, through the patient's body to the second electrode, and back to the stimulation system.
本发明的另一个方面提供了装置、系统与方法，包括手持组织刺激装置，此手持组织刺激装置包括具有抓握基部与操作元件调节部分的管状壳体，此抓握基部包括第一壳体元件与第二壳体元件；定位在抓握基部内的刺激控制装置；电池，其定位在抓握基部内并且联接到刺激控制装置以将功率提供到刺激控制装置；视觉指示，其联接到抓握基部的近端，此视觉指示包括照明周向环形指示器，此照明周向环形指示器在管状壳体的周边周围是可见的；以及操作元件，其具有尺寸设计并且构造为用于目标组织区域的电刺激的导电表面，此操作元件联接到刺激控制装置并且从操作元件调节部分的近端延伸。Another aspect of the present invention provides devices, systems and methods including a hand-held tissue stimulation device comprising a tubular housing having a grip base and an operative element adjustment portion, the grip base comprising a first housing element With the second housing element; the stimulation control device positioned in the grip base; the battery, which is positioned in the grip base and coupled to the stimulation control device to provide power to the stimulation control device; the visual indication, which is coupled to the grip the proximal end of the base, the visual indication comprising an illuminated circumferential annular indicator visible around the periphery of the tubular housing; and an operative element sized and configured for a target tissue area The electrostimulating conductive surface of the operative element is coupled to the stimulation control device and extends from the proximal end of the operative element adjustment portion.
操作元件调节部分可以包括尺寸设计并且构造为允许操作元件的移动的柔性鼻锥，并且视觉指示还包括反射元件。返回电极可以电联接到刺激控制装置。The operating element adjustment portion may include a flexible nose cone sized and configured to allow movement of the operating element, and the visual indication further includes a reflective element. The return electrode can be electrically coupled to the stimulation control device.
根据本发明的又一个方面，成套装置提供了对目标组织区域的组织刺激。此套件可以包括手持刺激探针，此手持刺激探针包括尺寸设计并且构造为通过左手或右手保持的壳体，该刺激探针是无菌的并且是一次性的，并且包括从壳体的近端延伸的操作元件，壳体近端可以包括：允许操作元件的移动的操作元件调节部分；包括联接到刺激探针的返回电极的引导件；以及用于描述取出刺激探针与用于刺激探针的组织接触手术的说明。According to yet another aspect of the invention, a kit provides tissue stimulation of a targeted tissue region. The kit may include a hand-held stimulation probe comprising a housing sized and configured to be held by the left or right hand, the stimulation probe is sterile and disposable, and includes an access point from the housing. An operating element extending at the end, the proximal end of the housing may include: an operating element adjustment portion allowing movement of the operating element; a guide including a return electrode coupled to a stimulating probe; Illustration of needle tissue contact surgery.
本发明的其它方面提供了电联接到组织切割装置的刺激控制装置，或者电联接到钻孔装置的刺激控制装置，或者电联接到先导螺旋钻以用于在先导孔钻孔以前的硬表面旋转探测的刺激控制装置，或者电联接到通常在脊椎稳固手术与内骨固定手术中使用的固定装置的刺激控制装置。Other aspects of the invention provide a stimulation control device electrically coupled to a tissue cutting device, or a stimulation control device electrically coupled to a drilling device, or electrically coupled to a pilot auger for hard surface rotation prior to drilling a pilot hole A probed stimulation control device, or a stimulation control device electrically coupled to a fixation device commonly used in spinal stabilization surgery and internal bone fixation surgery.
在另一个方面中，本发明提供了用于产生刺激电流并且将刺激电流提供到组织的第一装置。此装置、系统与方法还包括用于传感对电刺激电流的施加的期望的生理反应的存在与否的第二装置。预期生理反应的存在指示组织区域内的目标神经纤维或分支的神经分布。一旦区分与识别，目标神经纤维或分支就可以操作为实现期望的诊断和/或治疗结果。In another aspect, the present invention provides a first device for generating and providing a stimulating current to tissue. The devices, systems and methods also include a second means for sensing the presence or absence of a desired physiological response to the application of the electrical stimulation current. The presence of an expected physiological response is indicative of the innervation of target nerve fibers or branches within the tissue region. Once differentiated and identified, the targeted nerve fibers or branches can be manipulated to achieve a desired diagnostic and/or therapeutic outcome.
此装置、系统、和方法例如良好地适于区分和/或识别迷走神经的局部分支。迷走神经从脑部延伸通过面部与胸腔到腹部。它是包括副交感神经纤维的混合神经。迷走神经具有脑神经的最广泛分布。其咽与喉分支将运动冲动传送到咽喉；其心脏分支用于使心跳速率减慢；其支气管分支用于限制支气管；并且其食管分支控制食道、胃、胆囊、胰腺、小肠中的不随意肌并且刺激肠蠕动和胃肠道分泌物。能够区分和/或识别身体内的给定组织区域内的迷走神经的分支的存在使得能够发展与应用多种诊断和/或治疗技术以便多种解剖功能的副交感神经调节，例如，在消化系统、呼吸系统或心脏中。Such devices, systems, and methods are, for example, well suited to distinguishing and/or identifying local branches of the vagus nerve. The vagus nerve runs from the brain through the face and chest to the abdomen. It is a mixed nerve that includes parasympathetic fibers. The vagus nerve has the widest distribution of the cranial nerves. Its pharyngeal and laryngeal branches transmit motor impulses to the throat; its cardiac branch slows the heart rate; its bronchial branch restricts the bronchi; and its esophageal branch controls involuntary muscles in the esophagus, stomach, gallbladder, pancreas, small intestine And stimulate bowel movements and gastrointestinal secretions. The ability to differentiate and/or identify the presence of branches of the vagus nerve within a given tissue region within the body enables the development and application of various diagnostic and/or therapeutic techniques for parasympathetic modulation of various anatomical functions, e.g., in the digestive system, respiratory system or heart.
例如，本发明的一个方面提供了能够区分与识别通过副交感迷走神经纤维支配的心脏的表面上的心外膜脂肪垫的装置、系统与方法。此装置、系统与方法由此使得能够进入心脏的副交感神经系统以为了疗效，诸如控制心室速率或者提供房室结脂肪垫的生理控制。For example, one aspect of the invention provides devices, systems and methods capable of distinguishing and identifying epicardial fat pads on the surface of the heart innervated by parasympathetic vagal fibers. The devices, systems and methods thus enable access to the parasympathetic nervous system of the heart for therapeutic effects, such as controlling ventricular rate or providing physiological control of the atrioventricular node fat pad.
本发明的另一个方面提供了用于治疗心脏的系统与方法，包括利用用于产生与施加刺激电流的第一装置将脂肪垫区域定位在通过副交感神经支配的心脏上，并且然后操纵脂肪垫的区域中的心脏的副交感神经系统以为了诊断或疗效。Another aspect of the present invention provides systems and methods for treating the heart comprising localizing a fat pad region on the heart innervated by parasympathetic nerves using a first means for generating and applying a stimulating current, and then manipulating the fat pad's The area of the heart's parasympathetic nervous system for diagnostic or therapeutic purposes.
在实施方式中，设有适配器。此适配器可以构造为连接到刺激控制装置。适配器可以是布置为连接到刺激装置的壳体的双极适配器。适配器可以包括夹具，此夹具具有构造为将操作元件容纳在其中的第一通道与其中具有返回操作元件的第二通道。返回操作元件与所述刺激控制装置的电路电联通。In an embodiment, an adapter is provided. This adapter can be configured to connect to a stimulus control device. The adapter may be a bipolar adapter arranged to connect to the housing of the stimulation device. The adapter may include a clamp having a first channel configured to receive the operative element therein and a second channel having the operative element returned therein. A return operative element is in electrical communication with the electrical circuitry of the stimulus control device.
在实施方式中，适配器可以是经皮适配器，其包括构造为连接到刺激装置的操作元件的连接器与连接到连接器的引线。针可以连接到引线以将电刺激信号传送到定位在目标患者的皮肤下面的目标组织。In an embodiment, the adapter may be a transcutaneous adapter comprising a connector configured to connect to an operative element of the stimulation device and leads connected to the connector. The needles can be connected to leads to deliver electrical stimulation signals to target tissue positioned under the skin of the target patient.
在下面的描述与附图，以及技术特征的附加说明中阐述了本发明的特征与优点。Features and advantages of the invention are set forth in the following description and drawings, as well as an additional description of technical features.
附图说明Description of drawings
图1是在不同医疗手术中使用的可与不同监控与治疗装置族结合使用的系统的示意图。Figure 1 is a schematic diagram of a system that can be used in conjunction with different families of monitoring and treatment devices used in different medical procedures.
图2是示出图1中示出的系统的示例性实施方式的立体图，此刺激控制装置可移除地联接到刺激探针，并且示出了通过系统的刺激信号路径。2 is a perspective view illustrating an exemplary embodiment of the system shown in FIG. 1 with the stimulation control device removably coupled to a stimulation probe and illustrating the stimulation signal path through the system.
图3A是一部分脱离的侧视图并且在剖面中示出了具有嵌入刺激探针内的刺激控制装置的刺激探针。Figure 3A is a side view, partially broken away and showing a stimulation probe in section with a stimulation control device embedded within the stimulation probe.
图3B是一部分脱离的侧视图并且在剖面中示出了具有嵌入刺激探针内的刺激控制装置的刺激探针，并且示出了选择性针状返回电极。Figure 3B is a side view, partially broken away and showing in section a stimulation probe with a stimulation control device embedded within the stimulation probe, and showing a selective needle return electrode.
图3C是一部分脱离的侧视图并且在剖面中示出了刺激探针的其它实施方式，此刺激探针具有壳体，该壳体包括抓握基部与柔性鼻锥，以及照明环形指示器。FIG. 3C is a side view, partially broken away and in cross-section showing other embodiments of a stimulation probe having a housing including a grip base and flexible nose cone, and an illuminated ring indicator.
图4A是图3c的刺激探针的侧视图，示出了在刺激探针上的适当位置中的使用者的手以移动柔性鼻锥。4A is a side view of the stimulation probe of FIG. 3c showing the user's hand in place on the stimulation probe to move the flexible nose cone.
图4B是图4A的刺激探针的侧视图，其示出了使柔性鼻锥弯曲的使用者的手。4B is a side view of the stimulation probe of FIG. 4A showing the user's hand bending the flexible nose cone.
图5是一部分脱离的侧视图并且在剖面中示出了柔性鼻锥、环形指示器、以及抓握基部的元件。Figure 5 is a side view, partly broken away and showing elements of the flexible nose cone, ring indicator, and grip base in section.
图6是刺激装置的期望的双相刺激脉冲输出的图形视图。6 is a graphical view of a desired biphasic stimulation pulse output of a stimulation device.
图7是示出在外科手术过程中图2中示出的刺激控制装置的几何形状如何协助其定位的视图。Figure 7 is a view showing how the geometry of the stimulation control device shown in Figure 2 assists in its positioning during a surgical procedure.
图8是贯穿附图示出的刺激控制装置可以包括的回路的框图。Fig. 8 is a block diagram of circuitry that may be included in a stimulus control device shown throughout the figures.
图9A和图9B是示出用于切割装置的刺激控制装置的立体图。9A and 9B are perspective views illustrating a stimulation control device for a cutting device.
图10A和图10B是示出用于钻孔或旋拧装置的刺激控制装置的立体图。10A and 10B are perspective views illustrating a stimulation control device for a drilling or screwing device.
图11A和图11B是示出用于先导螺旋钻装置的刺激控制装置的立体图。11A and 11B are perspective views illustrating a stimulation control device for a pilot auger device.
图12A和图12B是示出用于固定装置的刺激控制装置的立体图。12A and 12B are perspective views illustrating a stimulus control device for an immobilization device.
图13是结合图3C中示出的刺激探针使用的套件的平面视图，并且包括刺激探针以及使用说明。13 is a plan view of a kit for use with the stimulation probe shown in FIG. 3C and includes the stimulation probe and instructions for use.
图14是图3C中示出的刺激探针的立体图。Figure 14 is a perspective view of the stimulation probe shown in Figure 3C.
图15是图14中示出的刺激探针的分解图。FIG. 15 is an exploded view of the stimulation probe shown in FIG. 14 .
图16是用于区分和/或识别局部地受到目标神经支配的组织区域的系统的示意图。16 is a schematic illustration of a system for distinguishing and/or identifying regions of tissue locally innervated by target nerves.
图17A是结合图1中示出的系统使用的装置的侧视图，用于产生刺激电流并且将刺激电流施加到目标神经纤维或分支的区域中的组织。17A is a side view of a device used in conjunction with the system shown in FIG. 1 for generating and applying stimulating current to tissue in the area of targeted nerve fibers or branches.
图17B是图2A中示出的装置的另选实施方式的侧视图，并且具有单独的振幅与持续时间选择开关。Figure 17B is a side view of an alternative embodiment of the device shown in Figure 2A and having separate amplitude and duration selection switches.
图18A是图17A或图17B中示出的装置可以在其远端承载的双极电极阵列的一个实施方式的放大视图。Figure 18A is an enlarged view of one embodiment of a bipolar electrode array that the device shown in Figure 17A or Figure 17B may carry at its distal end.
图18B是图17A或图17B中示出的装置可以在其远端处承载的双极电极阵列的其它实施方式的放大视图。Figure 18B is an enlarged view of another embodiment of a bipolar electrode array that the device shown in Figure 17A or Figure 17B may carry at its distal end.
图18C是图17A或图17B中示出的装置可以在其远端处承载的双极环形电极阵列的其它实施方式的放大视图。Figure 18C is an enlarged view of other embodiments of bipolar ring electrode arrays that the device shown in Figure 17A or Figure 17B may carry at its distal end.
图19是临床医生操纵与图16中示出的系统相关的图17A中示出的装置的的描述性视图。19 is a descriptive view of a clinician manipulating the device shown in FIG. 17A in relation to the system shown in FIG. 16 .
图20是人类心脏的解剖后视图，其示出了通过副交感神经支配的脂肪垫的位置，当接近时，脂肪垫可以提供疗效。Figure 20 is an anatomical posterior view of a human heart showing the location of fat pads innervated by parasympathetic nerves which, when approached, can provide therapeutic benefits.
图21和图22是用于区分和/或识别通过副交感神经局部地支配的脂肪垫组织区域的图16中示出的系统的使用的示意图。21 and 22 are schematic illustrations of the use of the system shown in FIG. 16 for differentiating and/or identifying regions of fat pad tissue innervated locally by parasympathetic nerves.
图23是连接到双极适配器的刺激装置。Figure 23 is a stimulation device connected to a bipolar adapter.
图24是双极适配器连接器。Figure 24 is a bipolar adapter connector.
图25是双极连接器适配器的前视图。Figure 25 is a front view of the bipolar connector adapter.
图26是连接到刺激装置的双极适配器连接器。Figure 26 is a bipolar adapter connector connected to a stimulation device.
图27是通过夹具连接到刺激装置的双极适配器。Figure 27 is a bipolar adapter attached to a stimulation device via a clamp.
图28是具有单元夹具的双极适配器。Figure 28 is a bipolar adapter with a unit clamp.
图29是单元夹具。Figure 29 is a unit fixture.
图30是经皮适配器。Figure 30 is a percutaneous adapter.
在不偏离其精神或本质特性的情况下可以以几种形式体现本发明。在所附权利要求中，而不是在权利要求前面的特定描述中限定了本发明的范围。属于权利要求的等效含义与范围内的全部实施方式都由此旨在通过权利要求所包括。The present invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, not in the specific description preceding the claims. All embodiments falling within the meaning and range of equivalents of the claims are thereby intended to be embraced by the claims.
具体实施方式detailed description
本说明书公开了用于在外科手术过程中防护神经、肌肉和肌腱损伤或者确认神经、肌肉、与肌腱的同一性和/或位置以及估测它们的功能或者通过这些神经支配的肌肉的功能。此系统与方法尤其非常适于协助外科医生识别神经与肌肉以便确保在使用诸如刺激监控器、切割、钻孔、与旋拧装置、先导螺旋钻、与固定装置的医疗装置的医疗手术过程中神经与肌肉的整体性。为此原因，将在这些医疗装置的背景下描述此系统与方法。The present specification discloses methods for protecting nerves, muscles and tendons from injury during surgical procedures or for confirming the identity and/or location of nerves, muscles, tendons and assessing their function or the function of muscles innervated by these nerves. The system and method are particularly well-suited for assisting surgeons in identifying nerves and muscles in order to ensure proper nerve function during medical procedures using medical devices such as stimulation monitors, cutting, drilling, and screwing devices, pilot augers, and fixation devices. Integrity with the muscles. For this reason, the system and method will be described in the context of these medical devices.
此系统与方法理想地允许施加足够高等级的刺激信号以便在多个医疗手术中定位、刺激与评估神经或肌肉、或者神经与肌肉整体性，包括但不限于邻近目标组织区域评估，邻近神经评估或者以识别神经组织，评估神经是否完好(即，在外伤以后)以确定是否可能需要修复，评估肌肉收缩以确定是否肌肉受神经支配和/或是否肌肉完好和/或是否肌肉被切断，以及估测修复以后的肌肉与肌腱长度和作用或者在完成外科手术以前的肌腱传送。The system and method ideally allow the application of stimulation signals of a sufficiently high level to locate, stimulate and evaluate nerves or muscles, or nerve and muscle integrity, in a variety of medical procedures, including but not limited to adjacent target tissue area evaluation, adjacent nerve evaluation Or to identify nerve tissue, assess whether the nerve is intact (i.e., after trauma) to determine whether repair may be required, assess muscle contraction to determine if the muscle is innervated and/or if the muscle is intact and/or if the muscle has been severed, and assess Measuring muscle and tendon length and function after repair or tendon transmission prior to completion of surgery.
进一步，应该理解的是公开的系统与方法可适用于通过多种医疗装置在多种医疗手术中使用。通过非限定实例的方式，本发明的多个方面在要求夹紧医疗装置与内部观察装置的手术中具有应用。Further, it should be understood that the disclosed systems and methods are applicable for use in a variety of medical procedures with a variety of medical devices. By way of non-limiting example, aspects of the present invention have application in procedures requiring clamping of medical devices and internal viewing devices.
I.系统的概视图I. System overview
图1示出了用于在外科手术过程中定位与识别组织以及防护组织和/或骨损伤的说明性系统20。在示出的实施方式中，系统20构造为定位、监控与刺激贯穿身体的组织与其它结构。系统20包括单独地或者与刺激医疗装置族中的一个或多个结合操作的刺激控制装置22，刺激医疗装置族包括例如，刺激监控器或探针100、切割装置200、钻孔或旋拧装置300、先导螺旋钻400、以及固定装置500。FIG. 1 shows an illustrative system 20 for locating and identifying tissue and protecting tissue and/or bone damage during a surgical procedure. In the illustrated embodiment, system 20 is configured to locate, monitor and stimulate tissue and other structures throughout the body. System 20 includes stimulation control device 22 operating alone or in conjunction with one or more of a family of stimulating medical devices including, for example, stimulation monitor or probe 100, cutting device 200, drilling or screwing device 300 , pilot auger 400 , and fixture 500 .
在示例性实施方式中，并且如可以在图2中看到的，刺激控制装置22在系统20中用于产生电刺激信号29。刺激信号29从刺激控制装置22通过引导件24流动到医疗装置(例如，刺激探针100)。刺激信号29然后流动通过刺激探针100内的预定绝缘路径124并且流动到操作元件，诸如导电表面，即联接电极110。电极110定位在待刺激的患者的区域上或待刺激的患者的区域附近。在单极操作中，返回电极38(或无关电极)提供了从身体返回到控制装置22的电路径。如将在后面更加详细地描述的，可以以单极或双极构造操作刺激控制装置22。In an exemplary embodiment, and as can be seen in FIG. 2 , a stimulation control device 22 is used in the system 20 to generate an electrical stimulation signal 29 . Stimulation signals 29 flow from stimulation control device 22 through guide 24 to a medical device (eg, stimulation probe 100 ). Stimulation signal 29 then flows through predetermined insulating pathway 124 within stimulation probe 100 and to an operative element, such as a conductive surface, ie coupling electrode 110 . The electrodes 110 are positioned on or near the area of the patient to be stimulated. In monopolar operation, return electrode 38 (or an unrelated electrode) provides an electrical path from the body back to control device 22 . As will be described in more detail below, stimulation control device 22 may be operated in a monopolar or bipolar configuration.
刺激信号29适于提供装置的指示或状态。此指示可以包括物理运动响应(例如，抽动)，和/或来自刺激控制装置22的一个或多个视觉或声音信号，这为外科医生指示装置的状态，和/或电极110到神经、或者肌肉、或者神经与肌肉的紧密靠近。刺激控制装置还可以指示外科医生刺激控制装置适当地操作并且传送刺激电流。The stimulation signal 29 is adapted to provide an indication or status of the device. This indication may include a physical motor response (e.g., a twitch), and/or one or more visual or audible signals from the stimulation control device 22, which indicate the state of the device to the surgeon, and/or electrodes 110 to the nerve, or muscle , or the close proximity of nerves and muscles. The stimulation control device may also instruct the surgeon that the stimulation control device is operating properly and delivering stimulation current.
II.医疗装置II. Medical Devices
形成系统的一部分的刺激医疗装置的构造可以在形式与功能上改变。将描述说明性医疗装置的多个典型实施方式。The construction of stimulating medical devices forming part of the system may vary in form and function. Several exemplary embodiments of illustrative medical devices will be described.
A.刺激探针A. Stimulating probes
图3A到图3C示出了在外科手术过程中用于识别与测试神经和/或肌肉的手持刺激监控器或探针50的多个实施方式。如示出的，刺激探针50可以将刺激控制装置22的电路容纳在大体上管状壳体112内。刺激探针50理想的是符合人体工程学的、无菌、单次使用装置，其旨在用于外科手术过程中以识别神经与肌肉、肌肉附着物、或者使肌肉收缩以估计外科手术干预的质量或者对于外科手术干预的需要，或者估测已经通过视觉装置识别的神经的功能。刺激电极50例如可以利用环氧乙烷消毒。3A-3C illustrate various embodiments of a hand-held stimulation monitor or probe 50 for identifying and testing nerves and/or muscles during a surgical procedure. As shown, stimulation probe 50 may house the circuitry of stimulation control device 22 within generally tubular housing 112 . Stimulation probe 50 is ideally an ergonomic, sterile, single-use device intended to be used during a surgical procedure to identify nerves and muscles, muscle attachments, or to cause muscle contraction to assess the extent of a surgical intervention. quality or need for surgical intervention, or estimate the function of a nerve that has been identified by visual means. Stimulation electrode 50 can be sterilized with ethylene oxide, for example.
刺激探针50优选地尺寸足够小以便在外科手术过程中通过一只手保持与使用，并且符合人体工程学地设计为在左手或右手中使用。在典型实施方式中，刺激探针50可以具有大约20毫米到大约30毫米的宽度，并且理想地为大约25毫米。刺激探针50(不包括操作元件110)的长度可以是大约18厘米到大约22厘米，并且理想地为大约20厘米。操作元件110还可以包括角度和弯曲以方便在不需要大的切口的情况下进入到深层结构以及表面结构。下面将更加详细地描述操作元件110。与壳体112合并的视觉或声音指示器126给外科医生提供了关于刺激电流的要求与传送的可靠的反馈。The stimulation probe 50 is preferably sufficiently small in size to be held and used with one hand during a surgical procedure, and is ergonomically designed for use in either the left or right hand. In a typical embodiment, stimulation probe 50 may have a width of about 20 millimeters to about 30 millimeters, and desirably about 25 millimeters. The length of the stimulation probe 50 (not including the operative element 110) may be about 18 centimeters to about 22 centimeters, and desirably is about 20 centimeters. The operative element 110 may also include angles and bends to facilitate access to deep structures as well as superficial structures without the need for large incisions. The operating element 110 will be described in more detail below. A visual or audible indicator 126 incorporated into the housing 112 provides the surgeon with reliable feedback regarding the demand and delivery of stimulation current.
在图3C和图14中示出的一个实施方式中，刺激探针50包括壳体112，此壳体包括抓握基部60与操作元件调节部分62。操作元件110从调节部分62的近端延伸。为了协助外科医生将操作元件110布置在目标组织区域处，如将描述为鼻锥62的调节部分可以是柔性的。此柔性允许外科医生使用定位在鼻锥62上的手指或拇指以在目标组织区域(参见图4A和图4B)处对操作元件110的刺激尖端111的位置进行微调。外科医生能够通过手指与手掌夹紧抓握基部60，并且将拇指定位在鼻锥62上，并且利用通过拇指施加的压力,致使刺激尖端111移动同时保持抓握基部62的稳定位置。该柔性鼻锥62特征允许仅通过外科医生拇指(或者手指，根据刺激探针被如何保持)的移动精确控制刺激尖端111的位置。In one embodiment shown in FIGS. 3C and 14 , the stimulation probe 50 includes a housing 112 that includes a grip base 60 and an operative element adjustment portion 62 . The operating element 110 extends from the proximal end of the adjustment portion 62 . To assist the surgeon in placing the operative element 110 at the target tissue area, the adjustment portion, as will be described, of the nose cone 62 may be flexible. This flexibility allows the surgeon to use a finger or thumb positioned on the nose cone 62 to make fine adjustments to the position of the stimulating tip 111 of the operative element 110 at the target tissue area (see FIGS. 4A and 4B ). The surgeon can grip the grip base 60 with the fingers and palm and position the thumb on the nose cone 62 and, with pressure applied through the thumb, cause the stimulating tip 111 to move while maintaining the grip base 62 in a stable position. This flexible nose cone 62 feature allows precise control of the position of the stimulation tip 111 by movement of only the surgeon's thumb (or finger, depending on how the stimulation probe is held).
如图5中所示，柔性鼻锥62可以包括单个元件或者其可以包括至少内部64与外部66。为了促进刺激探针50的近端部分114的一定柔性，鼻锥62的内部64可以由具有一定柔性的热塑材料制成。一个实例可以是LUSTRAN.RTM.ABS348，或者类似材料。外部66可以包括较柔软的包覆成型部分并且可以由具有一定柔性的热塑性弹性体材料制成。一个实例可以是来自GLS公司的VERSAFLEX.TM.OM3060-1。鼻锥62理想地大体上是锥形的。例如，如图3A和图3B中所示，鼻锥62可以是圆形，或者如图3C中所示，鼻锥在形状上可以更加锥形。As shown in FIG. 5 , flexible nose cone 62 may comprise a single element or it may comprise at least an inner portion 64 and an outer portion 66 . To facilitate some flexibility of the proximal portion 114 of the stimulation probe 50, the interior 64 of the nose cone 62 may be made of a thermoplastic material having some flexibility. An example would be LUSTRAN.RTM.ABS348, or similar material. The outer portion 66 may include a softer overmolded portion and may be made of a somewhat flexible thermoplastic elastomer material. An example may be VERSAFLEX.TM.OM3060-1 from the company GLS. Nose cone 62 is desirably generally conical. For example, as shown in Figures 3A and 3B, the nose cone 62 may be circular, or as shown in Figure 3C, the nose cone may be more tapered in shape.
鼻锥62还可以包括一个或多个特征，诸如如图14中所示的肋部或凹部72，以改进刺激探针50在外科医生手中的抓握、控制与稳定性。Nose cone 62 may also include one or more features, such as ribs or recesses 72 as shown in FIG. 14, to improve grip, control, and stability of stimulation probe 50 in the surgeon's hand.
壳体112的抓握基部60还可以包括包覆成型部分68。包覆成型部分68可以包括抓握基部60的全部长度或者抓握基部60的仅一部分。柔软的包覆成型部分68可以包括如示出的、诸如凹部或肋部70的一个或多个特征，以改进刺激探针50在外科医生手内的抓握、控制与稳定性。包覆成型部分68可以包括与用于柔性鼻锥62的外部66的热塑性弹性体材料的相同或类似材料。The grip base 60 of the housing 112 may also include an overmolded portion 68 . The overmolded portion 68 may include the entire length of the grip base 60 or only a portion of the grip base 60 . The flexible overmold portion 68 may include one or more features as shown, such as dimples or ribs 70, to improve the grip, control and stability of the stimulation probe 50 within the surgeon's hand. The overmolded portion 68 may comprise the same or similar material as the thermoplastic elastomer material used for the outer portion 66 of the flexible nose cone 62 .
在一个实施方式中，刺激探针50包括承载绝缘引导件124的壳体112。绝缘引导件124将定位在壳体近端114处的操作元件110连接到壳体112内的电路22(参见图3A)。应该理解的是绝缘引导件不是必要的并且操作元件110可以联接到电路22(参见图3C)。在壳体112内的引导件124利用通常的绝缘装置(例如，线绝缘、垫圈、垫片、间隔件、套管等)与壳体112绝缘。操作元件110的传导性尖端111定位为与至少一个肌肉、或至少一个神经、或者至少一个肌肉与神经电传导性接触。In one embodiment, the stimulation probe 50 includes a housing 112 carrying an insulating lead 124 . An insulating guide 124 connects the operating element 110 positioned at the proximal end 114 of the housing to the electrical circuit 22 within the housing 112 (see FIG. 3A ). It should be understood that an insulating guide is not necessary and that the operative element 110 may be coupled to the circuit 22 (see FIG. 3C ). The guides 124 within the housing 112 are insulated from the housing 112 by conventional insulating means (eg, wire insulation, washers, spacers, spacers, bushings, etc.). The conductive tip 111 of the operative element 110 is positioned in electrically conductive contact with at least one muscle, or at least one nerve, or at least one muscle and nerve.
如示出的，刺激探针50是单极的并且在壳体的近端114处装配有单个操作元件(即，电极)110。返回电极130、131可以联接到刺激探针50并且根据执行的外科手术可以是多种电极类型中的任一个(例如桨、针、线、或表面)。如示出的，多个返回电极130、131联接到壳体远端118。在另选实施方式中，刺激装置50自身通过在操作元件110中包括返回电极可以是双极，这排除了使用联接到刺激探针50的返回电极。As shown, stimulation probe 50 is monopolar and is fitted with a single operative element (ie, electrode) 110 at proximal end 114 of the housing. Return electrodes 130, 131 may be coupled to stimulation probe 50 and may be any of a variety of electrode types (eg, paddle, needle, wire, or surface) depending on the surgical procedure being performed. As shown, a plurality of return electrodes 130 , 131 are coupled to the housing distal end 118 . In an alternative embodiment, the stimulation device 50 itself may be bipolar by including a return electrode in the operative element 110 , which precludes the use of a return electrode coupled to the stimulation probe 50 .
如示出与描述的，刺激探针50可以将刺激控制装置22的电路容纳在壳体112内。在此布置中，刺激探针50可以具有一个或多个使用者操作控制器。示出两个——155和160。电源开关155用于将刺激探针50打开与关闭(或者等待)的双重目的，并且此外可以分级以控制刺激信号幅度选择在预定范围内(例如，0.5、2.0、和20mA)。在此构造中，开关可以是四位开关。在首次使用刺激探针50以前，电源开关155位于关闭位置中并且使刺激探针保持关闭。在通过将开关155移动到幅度选择打开刺激探针50以后，关闭位置现在相当于等待状态，在此处将不传送刺激。在一个实施方式中，一旦打开刺激探针50，就不能关闭它，其仅可以返回到等待状态并且将保持操作持续预定的时间，例如至少大约七个小时。此特征旨在允许刺激探针50仅是单次使用装置，因此其不能关闭并且然后在以后的时间再次使用。As shown and described, stimulation probe 50 may house the circuitry of stimulation control device 22 within housing 112 . In this arrangement, stimulation probe 50 may have one or more user-operated controls. Two are shown - 155 and 160. The power switch 155 serves the dual purpose of turning the stimulation probe 50 on and off (or on standby), and can additionally be graded to control stimulation signal amplitude selection within predetermined ranges (eg, 0.5, 2.0, and 20 mA). In this configuration, the switch may be a four position switch. Before using the stimulation probe 50 for the first time, the power switch 155 is in the off position and keeps the stimulation probe off. After opening the stimulation probe 50 by moving the switch 155 to amplitude selection, the off position now corresponds to a waiting state, where no stimulation will be delivered. In one embodiment, once the stimulation probe 50 is turned on, it cannot be turned off, it can only return to a standby state and will remain operational for a predetermined period of time, such as at least about seven hours. This feature is intended to allow the stimulation probe 50 to be a single use device only, so it cannot be turned off and then used again at a later time.
脉冲控制装置160允许从预订范围调节刺激信号脉冲宽度(例如，大约零到大约200毫秒)。在一个实施方式中，脉冲控制器160可以是电位计以允许滑动控制以增加或减少在预订范围内的刺激信号脉冲宽度。The pulse control device 160 allows the stimulation signal pulse width to be adjusted from a predetermined range (eg, about zero to about 200 milliseconds). In one embodiment, the pulse controller 160 may be a potentiometer to allow a slide control to increase or decrease the pulse width of the stimulation signal within a predetermined range.
刺激脉冲可以具有在大约10Hz到大约20Hz的范围内的不可调节频率，并且理想地为大约16Hz。The stimulation pulses may have a non-adjustable frequency in the range of about 10 Hz to about 20 Hz, and desirably about 16 Hz.
作为典型实例，刺激脉冲理想地具有双相波形，在阴极(主要)相位期间具有受控的电流，并且净直流电流小于10微安，开关从大约0.5微安到大约20微安可调节，并且脉冲持续期间从大约零微秒直到大约200微秒可调节。在图6中示出了典型的双相刺激脉冲。As a typical example, the stimulation pulse ideally has a biphasic waveform, with controlled current flow during the cathodal (primary) phase, and a net DC current of less than 10 microamperes, the switch is adjustable from about 0.5 microamperes to about 20 microamperes, and The pulse duration is adjustable from about zero microseconds up to about 200 microseconds. A typical biphasic stimulation pulse is shown in FIG. 6 .
操作元件110在近端114处离开壳体112以将刺激电流传送到可兴奋组织。操作元件110包括传导材料的长度与直径，并且理想地除了最近端以外完全地绝缘，例如大约1.0毫米到大约10毫米，并且理想地大约4毫米到大约6毫米，其是非绝缘的并且用作刺激尖端或表面(或者也称作为有效电极)111以允许外科医生仅将刺激电流传送到目标组织。操作元件110的刺激表面111(有效电极)的小区域确保将刺激附近的可兴奋组织的高电流密度。绝缘材料113可以包括医用级热收缩。The operative element 110 exits the housing 112 at a proximal end 114 to deliver stimulation current to excitable tissue. The operative element 110 comprises a length and diameter of conductive material, and ideally is completely insulated except for the proximalmost end, such as about 1.0 mm to about 10 mm, and desirably about 4 mm to about 6 mm, which is non-insulated and serves as a stimulus The tip or surface (or also referred to as active electrode) 111 to allow the surgeon to deliver stimulation current only to the target tissue. The small area of the stimulation surface 111 (active electrode) of the operative element 110 ensures a high current density that will stimulate nearby excitable tissue. The insulating material 113 may include medical grade heat shrink.
操作元件110的传导材料包括具有大约0.5毫米到大约1.5毫米之间的范围的直径，并且理想地可以是大约1.0毫米。操作元件110的长度可以大约是50毫米到大约60毫米，尽管应该理解的是此长度可以根据特定应用改变。如示出的，操作元件110可以包括一个或多个弯曲部以方便刺激表面111的准确布置。在一个实施方式中，尽管可以使用其它已知传导材料，但是操作元件110的传导材料由不锈钢304固线制成。The conductive material of the operative element 110 includes a diameter having a range between about 0.5 millimeters to about 1.5 millimeters, and desirably may be about 1.0 millimeters. The length of the operating element 110 may be about 50 millimeters to about 60 millimeters, although it should be understood that this length may vary depending on the particular application. As shown, the operative element 110 may include one or more bends to facilitate accurate placement of the stimulation surface 111 . In one embodiment, the conductive material of the operating element 110 is made of stainless steel 304 solid wire, although other known conductive materials may be used.
如前所述，在单极操作中，返回电极(或者无关电极)130或131例如提供了从身体返回到壳体112内的控制装置22的电路径。返回电极130(参见图3A)可以布置在完整皮肤的表面上(例如，如用于外科手术过程中的ECG监控的表面电极)或者其可以是针状131(参见图3B和图3C)并且布置在外科手术区域或者穿过完整皮肤。壳体远端118可以包括连接器或插座120，其提供了用于诸如通过具有相关柱塞122的表面电极130或针电极131的返回电流路径的选择。应该理解的是返回电极与相关引导件可以是刺激电极50的一体部分，即没有如图3C中所示的柱塞或连接器。As previously mentioned, in unipolar operation, the return electrode (or extraneous electrode) 130 or 131 , for example, provides an electrical path from the body back to the control device 22 within the housing 112 . Return electrode 130 (see FIG. 3A ) may be placed on the surface of intact skin (eg, as a surface electrode for ECG monitoring during surgery) or it may be needle-like 131 (see FIGS. 3B and 3C ) and placed In surgical areas or through intact skin. The housing distal end 118 may include a connector or receptacle 120 that provides options for a return current path such as through a surface electrode 130 or a needle electrode 131 with an associated plunger 122 . It should be understood that the return electrode and associated lead may be an integral part of the stimulation electrode 50, ie without the plunger or connector as shown in Figure 3C.
此外，装置50可以期望地包括用于外科医生的视觉或声音指示器126。此视觉或声音指示器126允许外科医生确认刺激器50将刺激电流传送到其接触的组织。通过使用不同的音调、颜色、不同的闪光速率等，指示器126(其可以采用例如光发射二极管(LED)的形式)允许外科医生确认刺激尖端111在适当位置处，装置打开，并且刺激电流正在流动。由此外科医生对于不能引起肌肉收缩是因为缺少在刺激器50的尖端111附近的可行神经组织而不是返回电极连接的故障或者一些其它装置问题具有更大信心。Additionally, device 50 may desirably include visual or audible indicators 126 for the surgeon. This visual or audible indicator 126 allows the surgeon to confirm that the stimulator 50 is delivering stimulation current to the tissue it contacts. By using different tones, colors, different flash rates, etc., the indicator 126 (which may take the form of, for example, a light-emitting diode (LED)) allows the surgeon to confirm that the stimulation tip 111 is in place, that the device is on, and that the stimulation current is on. flow. The surgeon thus has greater confidence that the inability to induce muscle contraction is due to a lack of viable nerve tissue near the tip 111 of the stimulator 50 rather than a failure of the return electrode connection or some other device problem.
作为典型实例，在使用中，指示器126可以构造为当打开刺激探针50但是不与组织接触时以一种颜色持续地照亮。在实现与组织接触以后，指示器126可以闪烁(即，闪光)以指示刺激正在被传送。如果要求此刺激，即打开刺激探针，但是由于在操作元件110与返回电极130之间缺少持续性，或者操作元件110或返回电极130到患者组织不充分连接而未传送刺激，那么指示器126可以以不同颜色照亮，并且可以持续地照亮或者闪烁。As a typical example, in use, the indicator 126 may be configured to illuminate continuously in one color when the stimulation probe 50 is on but not in contact with tissue. After contact with tissue is achieved, indicator 126 may flash (ie, flash) to indicate that stimulation is being delivered. If this stimulation is required, that is, the stimulation probe is turned on, but stimulation is not delivered due to lack of continuity between the operative element 110 and the return electrode 130, or insufficient connection of the operative element 110 or the return electrode 130 to the patient's tissue, then the indicator 126 Can be illuminated in different colors and can be continuously illuminated or flashing.
在一个实施方式中，如在图3C和图5中可以最佳看到的，指示器126包括视觉指示的环形指示器128，其提供围绕大体上在柔性鼻锥62附近的刺激探针50的至少部分并且理想地全部周边的的。视觉环形指示器128可以是抓握部分60的元件，或者其可以是柔性鼻锥62的元件，或者环形指示器可以定位在抓握部分60与柔性鼻锥62之间。环指示器128还可以包括反射元件129以改进并集中发光源，例如一个或多个LEDs的照明效果。环形指示器128与反射元件可以是单个部件，或者多个部件(如可以在图5和图15中看到的)。In one embodiment, as best seen in FIGS. 3C and 5 , the indicator 126 includes a visually indicated annular indicator 128 that provides a clear view of the stimulation probe 50 surrounding the flexible nose cone 62 generally in the vicinity. At least partially and ideally all peripheral. The visual ring indicator 128 may be an element of the grip portion 60 , or it may be an element of the flexible nose cone 62 , or the ring indicator may be positioned between the grip portion 60 and the flexible nose cone 62 . The ring indicator 128 may also include a reflective element 129 to improve and focus the lighting effect of a light source, such as one or more LEDs. The ring indicator 128 and reflective element may be a single piece, or multiple pieces (as can be seen in FIGS. 5 and 15 ).
声音反馈还使得在外科手术过程中通过监控神经整体性协助外科医生的特征成为可能。绝缘引导件124连接到操作元件110，其在使用中定位在远离外科手术位置的神经上的外科手术区域内。神经刺激致使肌肉向远端地收缩。包括在壳体112内的刺激控制装置22可以编程为提供以规定间隔跟随有刺激脉冲的声音音调。声音音调提醒外科医生观察远端肌肉收缩以便当刺激时确认神经正在起作用并且是完好的。Acoustic feedback also enables features that assist the surgeon by monitoring neurological integrity during surgery. The insulating guide 124 is connected to the operative element 110 which, in use, is positioned within the surgical field on the nerve away from the surgical site. Nerve stimulation causes the muscle to contract distally. Stimulation control device 22 included within housing 112 may be programmed to provide sound tones followed by stimulation pulses at prescribed intervals. The tone of the sound alerts the surgeon to watch the distal muscles contract to confirm that the nerve is functioning and intact when stimulated.
图15示出了典型刺激探针50的分解图。如可以看到的，刺激控制装置22定位在壳体112内。电池34电联接到控制装置22。第一壳体元件90与第二壳体元件92部分地封装控制装置22。环形指示器128与反射元件129联接到壳体112的近端。操作元件110延伸通过鼻锥62并且联接到控制装置22。期望地，将以符合至少IPX1标准的方式构造刺激探针50以用于水侵入。FIG. 15 shows an exploded view of a typical stimulation probe 50 . As can be seen, stimulus control device 22 is positioned within housing 112 . The battery 34 is electrically coupled to the control device 22 . The first housing element 90 and the second housing element 92 partially enclose the control device 22 . Ring indicator 128 and reflective element 129 are coupled to the proximal end of housing 112 . Operating element 110 extends through nose cone 62 and is coupled to control device 22 . Desirably, the stimulation probe 50 will be configured for water intrusion in a manner that meets at least IPX1 standards.
另选地，如图2所示，刺激控制装置22可以容纳在单独壳体中，具有其自身的输入/输出(I/O)控制器26。在此另选布置中，刺激控制装置22的尺寸设计为足够小以便在外科手术过程中易于可移除地紧固到外科医生手臂或腕部，或者另外地紧邻外科手术位置定位(如图7中所示)，以将足够的声音和/或视觉反馈提供到外科医生。在此布置中，单独的刺激控制装置22可以通过引导件临时地联接到不同的医疗装置族以便使用。Alternatively, as shown in FIG. 2 , stimulus control device 22 may be housed in a separate housing, with its own input/output (I/O) controller 26 . In this alternative arrangement, the stimulation control device 22 is sized small enough to be easily removably fastened to the surgeon's arm or wrist during the surgical procedure, or otherwise positioned in close proximity to the surgical site (as in FIG. 7 ). shown in ) to provide sufficient audible and/or visual feedback to the surgeon. In this arrangement, a single stimulation control device 22 may be temporarily coupled to a different medical device family through the guide for use.
本发明包括在患者中识别/定位组织(例如，神经或肌肉)的方法，其包括步骤：提供如上所述的手持刺激探针50、100；使患者与第一操作元件110与第二电极130接合；将电源开关155移动到致动位置,致使通过刺激控制装置22产生刺激信号29并且将刺激信号传送到第一操作元件110，通过患者的身体到第二电极130，并且返回到刺激控制装置22。此方法还可以包括观察指示器126以确认刺激探针50、100产生刺激信号的步骤。此方法还可以包括观察组织区域以观察组织移动或其缺少的步骤。The present invention includes a method of identifying/locating tissue (e.g., nerve or muscle) in a patient comprising the steps of: providing a hand-held stimulating probe 50, 100 as described above; Engage; move the power switch 155 to the actuated position, causing the stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first operative element 110, through the patient's body to the second electrode 130, and back to the stimulation control device twenty two. The method may also include the step of observing the indicator 126 to confirm that the stimulation probe 50, 100 produces a stimulation signal. The method may also include the step of observing the tissue region to observe tissue movement or lack thereof.
B.刺激控制装置B. Stimulus control device
如图8所示，刺激控制装置22包括产生电刺激波形的回路32。电池34理想地提供电源。控制装置22还理想地包括承载嵌入代码的板上、可编程微处理器36。此代码表述了预先编程规则或者算法以便利用刺激输出电路46产生期望的电刺激波形并且用于基于由外科医生致动的控制器操作可见或可听的指示器126。As shown in FIG. 8, the stimulation control device 22 includes a circuit 32 for generating electrical stimulation waveforms. A battery 34 ideally provides power. The control unit 22 also desirably includes an on-board, programmable microprocessor 36 carrying embedded code. This code expresses pre-programmed rules or algorithms for generating desired electrical stimulation waveforms with stimulation output circuit 46 and for operating visual or audible indicators 126 based on controls actuated by the surgeon.
在一种形式中，刺激控制装置22的尺寸与构造使得装置不那么昂贵，其没有手动内部电路调节。很可能的是将利用自动电路板组件装置与方法来制造此种类型的刺激控制装置22。In one form, the size and configuration of the stimulus control device 22 makes the device less expensive, without manual internal circuit adjustments. It is likely that this type of stimulus control device 22 will be fabricated using automated circuit board assembly equipment and methods.
C.结合外科手术装置C. Incorporating Surgical Devices
如刚刚描述的刺激控制装置22可以通过引导件电联接或者嵌入通常在外科手术中使用的多种装置内(如前面对于刺激探针50描述的)。Stimulation control device 22 as just described may be electrically coupled through a lead or embedded within a variety of devices commonly used in surgery (as previously described for stimulation probe 50 ).
1.切割装置1. Cutting device
在图9A和图9B中，除了装置200包括提供“通电”外科手术装置或工具的其它特征以外，装置200示出为其包括在刺激探针50、100的描述中公开的全部特征。图9A示出了工具是可移除地联接到刺激控制装置22的切割装置200(例如，解剖刀)。In FIGS. 9A and 9B , the device 200 is shown as including all of the features disclosed in the description of the stimulation probe 50 , 100 , except that the device 200 includes other features that provide an "energized" surgical device or tool. FIG. 9A shows that the tool is a cutting device 200 (eg, a scalpel) removably coupled to a stimulation control device 22 .
在示出的实施方式中，切割装置200包括承载绝缘引导件224的本体212。绝缘引导件224连接到操作元件，诸如定位在本体近端214的电极210，以及在本体远端118的插入接收件219。利用通常的绝缘装置(例如，线绝缘、垫圈、垫片、间隔件、衬套等)使本体212内的引导件224与本体212绝缘。In the illustrated embodiment, the cutting device 200 includes a body 212 carrying an insulating guide 224 . The insulating guide 224 is connected to an operative element, such as an electrode 210 positioned at the proximal body end 214 , and an insertion receptacle 219 at the distal body end 118 . The guides 224 within the body 212 are insulated from the body 212 using conventional insulating means (eg, wire insulation, washers, spacers, spacers, bushings, etc.).
在此实施方式中，电极210执行切割特征(例如，刀或剃刀)。电极210执行与至少一个肌肉、或者至少一个神经、或者至少一个肌肉与神经电传导性接触的切割特征。切割装置200理想地包括用于电极210的插入接收件216，以允许根据执行的特定外科手术使用多种切割电极的形状与类型(例如，刀、剃刀、尖的、钝的、弯曲的)。在此构造中，引导件224通过插入接收件219与引导件24将电极210电连接到刺激控制装置22。In this embodiment, the electrode 210 implements a cutting feature (eg, a knife or razor). Electrode 210 performs the cutting feature in electrical conductive contact with at least one muscle, or at least one nerve, or at least one muscle and nerve. Cutting device 200 desirably includes insertion receptacles 216 for electrodes 210 to allow for the use of a variety of cutting electrode shapes and types (eg, knife, razor, pointed, blunt, curved) depending on the particular surgical procedure being performed. In this configuration, lead 224 electrically connects electrode 210 to stimulation control device 22 by inserting receptacle 219 with lead 24 .
在一个实施方式中，切割装置200是单极并且在本体近端214装配有单电极210。在单极模式中，刺激控制装置22包括用作用于刺激信号的返回路径的返回电极38。根据执行的外科手术，电极38可以是多种电极类型(桨、针、线或表面)中的任一个。返回电极38可以通过连接器或插入接收件39附接到刺激装置22。在另选实施方式中，切割装置200可以是双极，这排除了返回电极38的使用。In one embodiment, the cutting device 200 is monopolar and is equipped with a single electrode 210 at the proximal body end 214 . In unipolar mode, the stimulation control device 22 includes a return electrode 38 that acts as a return path for the stimulation signal. Electrode 38 may be any of a variety of electrode types (paddle, needle, wire, or surface) depending on the surgical procedure being performed. Return electrode 38 may be attached to stimulation device 22 via a connector or plug-in receptacle 39 . In alternative embodiments, cutting device 200 may be bipolar, which precludes the use of return electrode 38 .
在图9B中示出的实施方式中，切割装置200将刺激控制装置22的电路容纳在本体212内。在此布置中，切割装置200可以具有至少两个操作滑动控制器255和260。电源开关255用于将到切割装置200的刺激信号打开与关闭的双重目的，并且此外分级以从预定范围(例如，0.5、2.0、和20mA)控制刺激信号幅度选择。脉冲控制开关260允许从预订范围(例如，零到200微秒)调节刺激信号脉冲宽度。In the embodiment shown in FIG. 9B , cutting device 200 houses the circuitry of stimulation control device 22 within body 212 . In this arrangement, cutting device 200 may have at least two operating slide controls 255 and 260 . Power switch 255 serves the dual purpose of turning the stimulation signal to cutting device 200 on and off, and is additionally graded to control stimulation signal amplitude selection from predetermined ranges (eg, 0.5, 2.0, and 20 mA). The pulse control switch 260 allows the stimulation signal pulse width to be adjusted from a predetermined range (eg, zero to 200 microseconds).
在本体远端218处，第二插入接收件220可以定位为接收第二引导件222。引导件222连接到电极230，当切割装置200以单极模式操作时，电极230用作用于刺激信号的返回路径。At the body distal end 218 , a second insertion receiver 220 may be positioned to receive a second guide 222 . Lead 222 is connected to electrode 230, which serves as a return path for the stimulation signal when cutting device 200 is operating in monopolar mode.
此外，如前所述，装置200可以包括供外科医生用的视觉或声音指示器。Additionally, device 200 may include visual or audible indicators for the surgeon, as previously described.
本发明包括在患者中识别/定位例如神经或肌肉的组织的方法，其包括步骤：提供如上面阐述的切割装置200；使患者与第一电极210和第二电极230接合；将电源开关255移动到致动位置，致使通过刺激控制装置22产生刺激信号29并且将刺激信号传送到第一电极210，通过患者的身体到第二电极230，并且返回到刺激控制装置22。此方法还包括观察指示器126的步骤以确认切割装置200产生刺激信号。此方法还可以包括观察组织区域以观察组织移动或其缺少的步骤。The present invention includes a method of identifying/locating tissue such as a nerve or muscle in a patient comprising the steps of: providing a cutting device 200 as set forth above; engaging the patient with the first electrode 210 and the second electrode 230; moving the power switch 255 To the actuated position, causes a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first electrode 210 , through the patient's body to the second electrode 230 , and back to the stimulation control device 22 . The method also includes the step of observing indicator 126 to confirm that cutting device 200 produces a stimulation signal. The method may also include the step of observing the tissue region to observe tissue movement or lack thereof.
2.钻孔装置2. Drilling device
在图10A和图10B中，除了装置300包括提供包括钻孔装置300的“通电”外科手术装置或工具的其它特征以外，装置300示出为包括在刺激探针50、100的描述中公开的全部特征。在图10A中，钻孔装置300可移除地联接到刺激控制装置22。In FIGS. 10A and 10B , the device 300 is shown as including the devices disclosed in the description of the stimulation probes 50 , 100 , except that the device 300 includes other features that provide an “energized” surgical device or tool including the drilling device 300 . All features. In FIG. 10A , drilling device 300 is removably coupled to stimulation control device 22 .
在示出的实施方式中，钻孔装置300包括承载绝缘引导件324的本体312。绝缘引导件324连接到操作元件，诸如定位在本体近端314的电极310，以及在本体远端318处的插入接收件319。利用通常的绝缘装置(例如，线绝缘、垫圈、垫片、间隔件、衬套等)使本体312内的引导件324与本体312绝缘。In the illustrated embodiment, the drilling device 300 includes a body 312 carrying an insulating guide 324 . The insulating guide 324 is connected to an operative element, such as an electrode 310 positioned at the proximal end 314 of the body, and an insertion receptacle 319 at the distal end 318 of the body. The guides 324 within the body 312 are insulated from the body 312 using conventional insulating means (eg, wire insulation, washers, spacers, spacers, bushings, etc.).
在此实施方式中，电极310执行钻孔特征。电极310还可以执行旋拧特征。电极310执行与硬结构(例如，骨)电传导性接触的钻孔特征。In this embodiment, electrode 310 performs a drilled feature. Electrode 310 may also perform a twist feature. The electrodes 310 perform a drilling feature that makes electrical conductive contact with a hard structure (eg, bone).
钻孔装置300理想地包括用于电极310的插入接收件或卡盘316，以允许根据执行的特定外科手术使用多种钻孔与旋拧电极形状与尺寸(例如1/4和3/8英寸钻头、Phillips驱动件和扁槽螺钉驱动件)。在此构造中，引导件324通过插入接收件319与引导件324将电极310电连接到刺激控制装置22。The drilling device 300 desirably includes an insertion receptacle or chuck 316 for the electrode 310 to allow the use of a variety of drilling and screwing electrode shapes and sizes (e.g., 1/4 and 3/8 inch drill bits, Phillips drivers, and slotted screw drivers). In this configuration, guide 324 electrically connects electrode 310 to stimulation control device 22 by inserting receptacle 319 and guide 324 .
在一个实施方式中，钻孔装置300是单极的并且在本体近端314处装配有单电极310。在单极模式中，刺激控制装置22包括用作用于刺激信号的返回路径的返回电极38。根据执行的外科手术，电极38可以是多种电极类型(桨、针、线或表面)中的任一个。返回电极38可以通过连接器或插入接收件39附接到刺激装置22。在另选实施方式中，钻孔装置300可以双极，这排除了使用返回电极38。In one embodiment, the drilling device 300 is monopolar and is equipped with a single electrode 310 at the proximal body end 314 . In unipolar mode, the stimulation control device 22 includes a return electrode 38 that acts as a return path for the stimulation signal. Electrode 38 may be any of a variety of electrode types (paddle, needle, wire, or surface) depending on the surgical procedure being performed. Return electrode 38 may be attached to stimulation device 22 via a connector or plug-in receptacle 39 . In an alternative embodiment, the drilling device 300 may be bipolar, which precludes the use of the return electrode 38 .
在图10B中，钻孔装置300示出为将刺激控制装置22的电路容纳在本体312内。钻孔装置300可以具有至少两个操作滑动控制器355和360。电源开关355用于将到钻孔装置300的刺激信号打开与关闭的双重目的，并且此外还分级以便从预定范围(例如，0.5、2.0、和20mA)控制刺激信号幅度选择。脉冲控制开关360允许从预订范围(例如，零到200微秒)调节刺激信号脉冲宽度。在本体远端318处，第二插入接收件320可以定位为容纳第二引导件322。引导件322连接到电极330，当钻孔装置300以单极模式操作时，电极330用作用于刺激信号的返回路径。In FIG. 10B , drilling device 300 is shown housing the circuitry of stimulation control device 22 within body 312 . The drilling device 300 may have at least two operating slide controls 355 and 360 . The power switch 355 serves the dual purpose of turning the stimulation signal to the drilling device 300 on and off, and is additionally graded to control stimulation signal amplitude selection from predetermined ranges (eg, 0.5, 2.0, and 20 mA). Pulse control switch 360 allows stimulation signal pulse width to be adjusted from a predetermined range (eg, zero to 200 microseconds). At the body distal end 318 , a second insertion receptacle 320 may be positioned to receive a second guide 322 . Lead 322 is connected to electrode 330, which serves as a return path for the stimulation signal when drilling device 300 is operating in monopolar mode.
此外，如前所述，装置300可以包括供外科医生用的视觉或声音指示器。Additionally, device 300 may include visual or audible indicators for the surgeon, as previously described.
本发明包括在患者中识别/定位例如神经或肌肉的组织的方法，其包括步骤：提供如上面阐述的钻孔装置300；使患者与第一电极310和第二电极330接合；将电源开关355移动到致动位置，致使通过刺激控制装置22产生刺激信号29并且将刺激信号传送到第一电极310，通过患者的身体到第二电极330，并且返回到刺激控制装置22。此方法还可以包括观察指示器126以确认钻孔装置400产生刺激信号的步骤。此方法还可以包括观察组织区域以观察组织移动或其缺少的步骤。The present invention includes a method of identifying/locating tissue such as a nerve or muscle in a patient comprising the steps of: providing a drilling device 300 as set forth above; engaging the patient with a first electrode 310 and a second electrode 330; switching the power switch 355 Movement to the actuated position causes a stimulation signal 29 to be generated by the stimulation control device 22 and transmitted to the first electrode 310 , through the patient's body to the second electrode 330 , and back to the stimulation control device 22 . The method may also include the step of observing the indicator 126 to confirm that the drilling device 400 produces a stimulation signal. The method may also include the step of observing the tissue region to observe tissue movement or lack thereof.
3.先导螺旋钻3. Pilot auger
本发明的其它方面提供了用于控制包括电联接到用于硬表面旋转探测的先导螺旋钻的刺激控制装置的刺激装置族的操作的系统与方法。Other aspects of the invention provide systems and methods for controlling the operation of a family of stimulation devices including a stimulation control device electrically coupled to a pilot auger for hard surface rotational probing.
除了此实施方式包括提供“通电”外科手术装置或工具的其它特征，本实施方式包括在刺激探针50、100的描述中公开的全部特征。图11A示出了可移除地联接到刺激控制装置22的先导螺旋装置400。在示出的实施方式中，先导螺旋钻装置400包括承载绝缘引导件424的本体412。绝缘引导件424连接到操作元件，诸如定位在本体近端414的电极410以及在本体远端418的插入接收件419。利用通常的绝缘装置(例如，线绝缘、垫圈、垫片、间隔件、衬套等)使本体412内的引导件424与本体412绝缘。在此实施方式中，电极410执行先导螺旋钻特征。电极410以与硬结构(例如，骨)电传导性接触执行先导螺旋钻特征。This embodiment includes all of the features disclosed in the description of the stimulation probe 50, 100, except that this embodiment includes other features that provide an "energized" surgical device or tool. FIG. 11A shows pilot helical device 400 removably coupled to stimulation control device 22 . In the illustrated embodiment, the pilot auger device 400 includes a body 412 carrying an insulating guide 424 . The insulating guide 424 is connected to operative elements such as the electrode 410 positioned at the proximal end 414 of the body and the insertion receptacle 419 at the distal end 418 of the body. The guides 424 within the body 412 are insulated from the body 412 by conventional insulating means (eg, wire insulation, washers, spacers, spacers, bushings, etc.). In this embodiment, electrode 410 performs a pilot auger characteristic. Electrode 410 performs the pilot auger feature in electrically conductive contact with a hard structure (eg, bone).
先导螺旋钻装置400理想地包括用于电极410的插入接收件或卡盘416，以允许根据执行的特定外科手术使用多种先导螺旋钻电极形状与尺寸(例如,1/32、1/16、以及1/8英寸)。在此构造中，引导件24通过插入接收件419与引导件24将电极410电连接到刺激控制装置22。The pilot auger device 400 desirably includes an insertion receptacle or chuck 416 for the electrode 410 to allow the use of a variety of pilot auger electrode shapes and sizes (e.g., 1/32, 1/16, and 1/8 inch). In this configuration, lead 24 electrically connects electrode 410 to stimulation control device 22 via insertion receptacle 419 with lead 24 .
在一个实施方式中，先导螺旋钻装置400是单极并且在本体近端414处装配有单电极410。在单极模式中，刺激控制装置22包括用作用于刺激信号的返回路径的返回电极38。根据执行的外科手术，电极38可以是多种电极类型(桨、针、线或表面)中的任一个。返回电极38可以通过连接器或插入接收件39附接到刺激装置22。在另选实施方式中，先导螺旋钻装置400可以是双极，这免除了返回电极38的使用。In one embodiment, the pilot auger device 400 is monopolar and is fitted with a single electrode 410 at the proximal body end 414 . In unipolar mode, the stimulation control device 22 includes a return electrode 38 that acts as a return path for the stimulation signal. Electrode 38 may be any of a variety of electrode types (paddle, needle, wire, or surface) depending on the surgical procedure being performed. Return electrode 38 may be attached to stimulation device 22 via a connector or plug-in receptacle 39 . In an alternative embodiment, the pilot auger device 400 may be bipolar, which eliminates the use of the return electrode 38 .
如图11B所示，先导螺旋钻装置400可以将刺激控制装置22的电路容纳在本体412内。在本体远端418处，第二插入接收件420可以定位为容纳第二引导件422。引导件422连接到电极430，当先导螺旋钻装置400以单极模式操作时，电极430用作用于刺激信号的返回路径。As shown in FIG. 11B , pilot auger device 400 may house the circuitry of stimulation control device 22 within body 412 . At the body distal end 418 , a second insertion receptacle 420 may be positioned to receive a second guide 422 . Lead 422 is connected to electrode 430, which serves as a return path for the stimulation signal when pilot auger device 400 is operating in monopolar mode.
先导螺旋钻装置400包括电源开关455。当移动到致动位置时，通过刺激控制装置22产生刺激信号。此外，如前所述，装置400可以包括用于外科医生的视觉或声音指示器。The pilot auger device 400 includes a power switch 455 . When moved into the actuated position, a stimulation signal is generated by the stimulation control device 22 . Additionally, device 400 may include visual or audible indicators for the surgeon, as previously described.
本发明包括在患者中识别/定位例如神经或肌肉的组织的方法，包括步骤：提供如上面阐述的先导螺旋钻装置400、使患者与第一电极410和第二电极430接合、将电源开关455移动到致动位置，致使通过刺激控制装置22产生刺激信号并且将刺激信号传送到第一电极410，通过患者的身体到第二电极430，并且返回到刺激控制装置22。此方法还包括观察指示器126以确认先导螺旋钻装置400产生刺激信号的步骤。此方法还可以包括观察组织区域以观察组织移动或其缺少的步骤。The present invention includes a method of identifying/locating tissue such as a nerve or muscle in a patient comprising the steps of: providing a pilot auger device 400 as set forth above, engaging the patient with a first electrode 410 and a second electrode 430, turning a power switch 455 Movement to the actuated position causes a stimulation signal to be generated by the stimulation control device 22 and transmitted to the first electrode 410 , through the patient's body to the second electrode 430 , and back to the stimulation control device 22 . The method also includes the step of observing indicator 126 to confirm that pilot auger device 400 is producing a stimulation signal. The method may also include the step of observing the tissue region to observe tissue movement or lack thereof.
D.结合固定装置D. Combining Fixtures
本发明的另一个方面提供了用于控制刺激装置族的操作的系统与方法，其包括电联接到固定装置或者用于布置固定装置的扳手或螺丝刀的刺激控制装置。在脊椎稳固手术(融合)与内骨固定手术过程中通常地使用固定装置(例如，整形外科用硬件、椎弓根螺钉)。Another aspect of the invention provides systems and methods for controlling the operation of a family of stimulation devices comprising a stimulation control device electrically coupled to a fixation device or a wrench or screwdriver for deploying a fixation device. Fixation devices (eg, orthopedic hardware, pedicle screws) are commonly used during spinal stabilization (fusion) and internal bone fixation procedures.
除了此实施方式包括提供“通电”固定装置或工具的其它特征，本实施方式包括在刺激探针50、100的描述中公开的全部特征。图12A示出了可移除地联接到刺激控制装置22的固定装置500。在示出的实施方式中，固定装置500包括还用作诸如电极510的操作元件的长方形形状本体512。固定装置500必要时可以采用数量不受限定的形状以用于发生的特定手术。可以利用椎弓根螺钉535将固定装置固定到骨结构。在与硬结构(例如，骨)的电传导性接触中电极510执行固定特征。This embodiment includes all of the features disclosed in the description of the stimulation probe 50, 100, except that this embodiment includes other features that provide an "energized" immobilization device or implement. FIG. 12A shows immobilization device 500 removably coupled to stimulation control device 22 . In the illustrated embodiment, the fixation device 500 includes a rectangular shaped body 512 that also serves as an operative element, such as an electrode 510 . Fixation device 500 may take an unlimited number of shapes, as necessary for the particular procedure occurring. Pedicle screws 535 may be utilized to secure the fixation device to the bony structure. Electrode 510 performs a fixation feature in electrically conductive contact with a hard structure (eg, bone).
固定装置500或用于布置固定装置的扳手或螺丝刀理想地包括插入接收件519。固定装置500可以根据将要执行的特定外科手术采用不受限定的多种形状与尺寸。在此构造中，引导件24通过插入接收件519将电极510电连接到刺激控制装置22。The fixture 500 or the wrench or screwdriver used to deploy the fixture desirably includes an insertion receptacle 519 . Fixation device 500 can take on a non-limiting variety of shapes and sizes depending on the particular surgical procedure to be performed. In this configuration, lead 24 electrically connects electrode 510 to stimulation control device 22 through insertion receptacle 519 .
在一个实施方式中，固定装置500是单极并且装配有单个电极510。在单极模式中，刺激控制装置22包括用作用于刺激信号的返回路径的返回电极38。根据执行的外科手术，电极38可以是多种电极类型(桨、针、线或表面)中的任一个。返回电极38可以通过连接器或插入接收件39附接到刺激装置22。在另选实施方式中，固定装置500可以是双极，其排除使用返回电极38。In one embodiment, immobilization device 500 is monopolar and fitted with a single electrode 510 . In unipolar mode, the stimulation control device 22 includes a return electrode 38 that acts as a return path for the stimulation signal. Electrode 38 may be any of a variety of electrode types (paddle, needle, wire, or surface) depending on the surgical procedure being performed. Return electrode 38 may be attached to stimulation device 22 via a connector or plug-in receptacle 39 . In an alternative embodiment, the immobilization device 500 may be bipolar, which precludes the use of the return electrode 38 .
在又一个另外的另选实施方式(参见图12B)中，固定装置可以是椎弓根螺钉535。椎弓根螺钉535可移除地联接到刺激控制装置22。在示出的实施方式中，椎弓根螺钉535包括头部570与轴572，其均用作诸如电极574的操作元件。当椎弓根螺钉535定位在骨结构内时，电极574执行与硬结构(例如，骨)电传导性接触的固定特征。引导件24通过脱离连接或者其它类似的电连接装置将电极574电连接到刺激控制装置22。固定装置535可以根据将要执行的特定外科手术采用不受限定的多种形状与尺寸。In yet another further alternative embodiment (see FIG. 12B ), the fixation device may be a pedicle screw 535 . Pedicle screw 535 is removably coupled to stimulation control device 22 . In the illustrated embodiment, pedicle screw 535 includes a head 570 and a shaft 572 , both of which serve as operative elements such as electrodes 574 . When the pedicle screw 535 is positioned within the bony structure, the electrode 574 performs a fixation feature that makes electrically conductive contact with the hard structure (eg, bone). Lead 24 electrically connects electrode 574 to stimulation control device 22 via a disconnect or other similar electrical connection. Fixation device 535 can take on a non-limiting variety of shapes and sizes depending on the particular surgical procedure to be performed.
在单极模式中，刺激控制装置22包括用作用于刺激信号的返回路径的返回电极38。根据执行的外科手术，电极38可以是多种电极类型(桨、针、线或表面)中的任一个。在另选实施方式中，固定装置500可以是双极，其排除使用返回电极38。In unipolar mode, the stimulation control device 22 includes a return electrode 38 that acts as a return path for the stimulation signal. Electrode 38 may be any of a variety of electrode types (paddle, needle, wire, or surface) depending on the surgical procedure being performed. In an alternative embodiment, the immobilization device 500 may be bipolar, which precludes the use of the return electrode 38 .
本发明包括在患者中识别/定位例如神经或肌肉的组织的方法，其包括步骤：提供如上面阐述的固定装置500；使患者与第一电极510与第二电极38接合；通过I/O控制器26打开刺激控制装置22的电源；致使通过致动通过刺激控制装置22产生刺激信号29并且将刺激信号传送到第一电极510，通过患者的身体到第二电极38，并且返回到刺激控制装置22。此方法还包括观察指示器126的步骤以确认固定装置500产生刺激信号。此方法还可以包括观察组织区域以观察组织移动或其缺少的步骤。The present invention includes a method of identifying/locating tissue such as a nerve or muscle in a patient comprising the steps of: providing the immobilization device 500 as set forth above; engaging the patient with the first electrode 510 and the second electrode 38; controlling via I/O The device 26 turns on the power supply of the stimulation control device 22; causes the stimulation signal 29 to be generated by the stimulation control device 22 by actuation and transmits the stimulation signal to the first electrode 510, through the patient's body to the second electrode 38, and back to the stimulation control device twenty two. The method also includes the step of observing the indicator 126 to confirm that the immobilization device 500 produces a stimulation signal. The method may also include the step of observing the tissue region to observe tissue movement or lack thereof.
IV.技术特征IV. Technical Features
刺激控制装置22，单独或当并入刺激探针或外科手术装置中时，可以包括多种技术特征以增强其通用性。The stimulation control device 22, alone or when incorporated into a stimulation probe or surgical device, may include a variety of technical features to enhance its versatility.
A.小尺寸A.Small size
根据一个期望的技术特征，刺激控制装置22的尺寸可以设计为足够小以便在外科手术过程中通过一只手保持与使用，或者安装在刺激探针或外科手术装置内。刺激尖端的角度方便在不需要大的切口的情况下进入到深层结构以及表面结构。并入壳体中的视觉和/或声音指示将关于刺激电流的要求与传送的可靠的反馈或状态提供到外科医生。Depending on a desired technical feature, the stimulation control device 22 may be sized small enough to be held and used with one hand during a surgical procedure, or mounted within a stimulation probe or surgical device. The angle of the stimulating tip facilitates access to deep as well as superficial structures without the need for large incisions. Visual and/or audible indications incorporated into the housing provide reliable feedback or status to the surgeon regarding the demand and delivery of stimulation current.
根据另选的期望技术特征，刺激控制装置22的尺寸还可以设计为足够小以便在外科手术过程中易于可移除地紧固到外科医生的手臂或腕部，或者紧邻外科手术位置定位(如图7中所示)，以便为外科医生提供足够的声音和/或视觉反馈。Depending on an alternative desired technical feature, the stimulus control device 22 may also be sized small enough to be easily removably fastened to the surgeon's arm or wrist during the surgical procedure, or positioned in close proximity to the surgical site (e.g. 7) to provide adequate audible and/or visual feedback to the surgeon.
B.电源B. Power supply
根据一个期望的技术特征，通过定位在壳体内部以及联接到控制装置22的一个或多个原电池34提供电源以便单次使用。代表性电池34可以包括尺寸"N"的碱性电池。在一个实施方式中，包括串联的两个尺寸"N"的碱性电池以提供3伏电源。此构造尺寸设计并且构造为提供连续或间断刺激的至少七小时操作的操作寿命。According to one desired technical feature, power is provided for single use by one or more primary batteries 34 positioned inside the housing and coupled to the control device 22 . Representative batteries 34 may include size "N" alkaline batteries. In one embodiment, two size "N" alkaline cells are included in series to provide a 3 volt power supply. This configuration is dimensioned and configured to provide an operating life of at least seven hours of operation with continuous or intermittent stimulation.
C.微处理器/微控制器C. Microprocessor/Microcontroller
根据一个期望的技术特征，刺激控制装置22理想地使用标准、商业上可获得的微电源、闪光可编程微控制器36。微控制器36读取通过外科医生操作的控制，控制刺激脉冲的时间、以及控制到使用者的关于装置状态的反馈(例如具有可以打开、关闭或闪烁的1、2或多种颜色的LED)。According to one desired technical feature, stimulus control device 22 desirably utilizes a standard, commercially available micropower, flash programmable microcontroller 36 . Microcontroller 36 reads the controls operated by the surgeon, controls the timing of stimulation pulses, and controls feedback to the user about the status of the device (e.g. LEDs with 1, 2 or more colors that can be turned on, off or blinked) .
此微控制器以低压与低功率操作。微控制器将低压脉冲发送到将这些低压信号转换成施加到电极回路的较高电压、受控电压、或受控电流、刺激脉冲的刺激输出阶段46。刺激输出阶段46通常地涉及使用一系列电容器以防止在正常操作中或者在电子部件故障的情况下在电极回路中DC电流流动的存在。This microcontroller operates at low voltage and low power. The microcontroller sends low voltage pulses to a stimulation output stage 46 that converts these low voltage signals into higher voltage, controlled voltage, or controlled current, stimulation pulses that are applied to the electrode circuit. The stimulation output stage 46 typically involves the use of a series of capacitors to prevent the presence of DC current flow in the electrode circuit during normal operation or in the event of electronic component failure.
V.刺激探针的代表性使用V. Representative Use of Stimulation Probes
如所述的刺激探针50、100使得能够施加足够高等级的刺激信号以便在多个医学手术中定位、刺激与评估神经或肌肉或者神经与肌肉整体性的目的，包括但不限于邻近目标组织区评估域，邻近神经评估或者以识别神经组织，评估是神经完否好(即，在外伤以后)以确定是否可能需要修复，评估肌肉收缩以确定是否肌肉受神经支配和/或是否肌肉完好和/或是否肌肉被切断，以及估测修复以后的肌肉与肌腱长度和作用或者完成外科手术以前的肌腱传送。Stimulation probes 50, 100 as described enable application of sufficiently high level stimulation signals for purposes of locating, stimulating and evaluating nerve or muscle or nerve and muscle integrity in a variety of medical procedures, including but not limited to adjacent target tissue Regional assessment domains, adjacent nerve assessment or to identify neural tissue, assessment of nerve integrity (i.e., after trauma) to determine if repair may be required, assessment of muscle contraction to determine if muscle is innervated and/or muscle integrity and and/or if the muscle was severed, and to estimate muscle and tendon length and function after repair or tendon transfer prior to completion of surgery.
使用说明80理想地包括在连同刺激探针50的套件82中。套件82可以采用多种形式。在示出的实施方式中，套件82包括无菌、包装组件。代表性套件82包括例如由冲模切割卡板、塑料板、或热形成塑料材料制成的保持内容物的内部托盘84。套件82还理想地包括使用说明80以便利用套件的内容物来执行期望的治疗和/或诊断目的。Instructions for use 80 are desirably included in a kit 82 along with stimulation probe 50 . Kit 82 may take a variety of forms. In the illustrated embodiment, kit 82 includes sterile, packaged components. A representative kit 82 includes an inner tray 84 that holds the contents, made, for example, of die-cut cardboard, plastic sheet, or thermoformed plastic material. Kit 82 also desirably includes instructions for use 80 for utilizing the contents of the kit to perform desired therapeutic and/or diagnostic purposes.
说明80通过取出刺激探针50，定位电极，以及丢弃单次使用可丢弃刺激器50的步骤指导使用者。代表性说明可以包括但不限于：Instructions 80 guide the user through the steps of removing stimulation probe 50 , positioning the electrodes, and discarding single use disposable stimulator 50 . Representative statements may include, but are not limited to:
(1)从无菌包装88移除刺激探针50。(1) The stimulation probe 50 is removed from the sterile package 88 .
(2)从操作元件110移除覆盖件94(例如，硅树脂覆盖件)。(2) The cover 94 (for example, a silicone cover) is removed from the operation element 110 .
(3)从返回电极131移除保护覆盖件86。(3) The protective cover 86 is removed from the return electrode 131 .
(4)将返回电极131定位为与患者接触使得：(4) Position the return electrode 131 in contact with the patient such that:
(a)返回电极期望地定位在远离待刺激区域的区域中；(a) the return electrode is desirably positioned in an area remote from the area to be stimulated;
(b)返回电极理想地不从被刺激的侧面横跨本体定位；以及(b) the return electrode is ideally not positioned across the body from the side being stimulated; and
(c)返回电极期望地不定位在肌肉组织中。(c) The return electrode is desirably not positioned in the muscle tissue.
(5)通过将电源开关155从关闭移动到0.5mA设定(或者更大)打开刺激探针50。(5) Turn on the stimulation probe 50 by moving the power switch 155 from OFF to the 0.5 mA setting (or greater).
(6)在操作元件110与组织接触以前理想地打开刺激探针50。(6) Ideally, the stimulation probe 50 is turned on before the operating element 110 comes into contact with the tissue.
(7)如果刺激探针50打开但不与组织接触，那么指示器126将被持续地照明黄色(例如)。(7) If the stimulation probe 50 is on but not in contact with tissue, the indicator 126 will be illuminated continuously yellow (for example).
(8)使组织与操作元件110接触。(8) The tissue is brought into contact with the operating element 110 .
(9)逐渐地调节脉冲控制器160以增加刺激的等级。(9) Gradually adjust the pulse controller 160 to increase the level of stimulation.
(10)指示器126将闪烁黄色以指示刺激被传送。(10) Indicator 126 will flash yellow to indicate that the stimulus was delivered.
(11)闪红色(例如)指示器126意味着要求刺激，但是因为操作元件110或返回电极131到患者组织的不充分连接不传送刺激。(11) Flashing red (for example) indicator 126 means that stimulation is required, but stimulation is not delivered because of insufficient connection of operative element 110 or return electrode 131 to patient tissue.
(12)检查返回电极接触与位置，并且检查操作元件110接触与位置。(12) Check the return electrode contact and position, and check the operation member 110 contact and position.
(13)将电源开关155布置在关闭/待机位置处将使刺激停止并且视觉指示器126将被持续地照明黄色。(13) Placing the power switch 155 in the off/standby position will stop stimulation and the visual indicator 126 will be continuously illuminated yellow.
(14)将脉冲控制器160布置在最小位置处将使刺激停止并且视觉指示器126将被持续地照明黄色。(14) Placing the pulse controller 160 in the minimum position will stop stimulation and the visual indicator 126 will be illuminated yellow continuously.
(15)低/耗尽电池34将致使刺激探针50自动地关闭并且将不会照亮视觉指示器126。(15) A low/depleted battery 34 will cause the stimulation probe 50 to automatically turn off and the visual indicator 126 will not be illuminated.
(16)不再进一步使用刺激器50将是可能的。(16) No further use of the stimulator 50 will be possible.
(17)在使用结束时，将电源开关155移动到关闭/待机位置并且将脉冲控制器160移动到最小位置。(17) At the end of use, move the power switch 155 to the off/standby position and move the pulse controller 160 to the minimum position.
(18)切断返回电极131并且将返回电极131丢弃到适当的锋利/生化危害容器中。(18) Cut off the return electrode 131 and discard the return electrode 131 into an appropriate sharps/biohazard container.
(19)根据医院或设施指导处理刺激探针50。(19) Handle the stimulation probe 50 according to the guidance of the hospital or facility.
在图16-图22中示出的实施方式中，此系统可以包括如下面进一步描述的双极刺激装置。In the embodiment shown in Figures 16-22, the system may include a bipolar stimulation device as described further below.
系统system
图16示出了用于区分和/或识别组织区域TR内的目标神经纤维或分支的存在的系统610。系统610包括用于产生刺激电流并且将刺激电流施加到目标神经纤维或分支的区域TR中的组织的第一系统612。此系统610还包括用于传感对电刺激电流的施加的期望的生理反应的存在与否的第二系统614。预期生理反应的存在区分和/或识别组织区域TR内的目标神经纤维或分支的存在。一旦区分与识别，就可以为了期望的诊断和/或治疗原因操纵目标的神经纤维或分支。FIG. 16 shows a system 610 for distinguishing and/or identifying the presence of target nerve fibers or branches within a tissue region TR. The system 610 includes a first system 612 for generating and applying a stimulating current to tissue in a region TR of a target nerve fiber or branch. This system 610 also includes a second system 614 for sensing the presence or absence of a desired physiological response to the application of electrical stimulation current. The presence of a physiological response is expected to distinguish and/or identify the presence of target nerve fibers or branches within the tissue region TR. Once differentiated and identified, the targeted nerve fibers or branches can be manipulated for desired diagnostic and/or therapeutic reasons.
A.第一装置A. First device
如图17A到图19所示，第一系统612包括把手616，此把手优选地尺寸设计为足够小以便像闪光灯或螺丝刀那样保持与使用，以允许拇指推动按钮以控制刺激电流的应用(参见图19)。把手616承载绝缘探针618。探针618在其远端承载电极组件620(参见图18A)。第一系统612优选地是无菌、单次使用装置。As shown in FIGS. 17A to 19 , the first system 612 includes a handle 616 that is preferably sized small enough to be held and used like a flashlight or screwdriver to allow a thumb push button to control the application of stimulation current (see FIG. 19). The handle 616 carries an insulated probe 618 . The stylet 618 carries an electrode assembly 620 at its distal end (see FIG. 18A ). The first system 612 is preferably a sterile, single-use device.
在代表性实施方式中，把手616是圆柱形形状并且在其近端具有大约25mm的最大直径。把手616从近端到远端逐渐缩小到大约10mm的较小直径。在代表性实施方式中，把手616的长度大约是17cm。In a representative embodiment, handle 616 is cylindrical in shape and has a maximum diameter at its proximal end of approximately 25 mm. The handle 616 tapers from proximal to distal to a smaller diameter of approximately 10 mm. In a representative embodiment, the handle 616 is approximately 17 cm in length.
在代表性实施方式中，探针618从把手616的远端延伸大约8cm并且在其远端包括电极组件620。在代表性实施方式中，探针618具有大约10mm的直径。In a representative embodiment, the stylet 618 extends approximately 8 cm from the distal end of the handle 616 and includes an electrode assembly 620 at its distal end. In a representative embodiment, probe 618 has a diameter of approximately 10 mm.
电极组件620(参见图18A)的尺寸设计并且构造为准确识别通过目标神经支配的组织区域。电极组件620可以构造为与类似如牙镜的某物并且可以具有在大约10mm到大约15mm的范围内的直径。组件620可以略微偏离(例如10度到50度)探针618以提供容易使用与更加人体工程学构造。电极组件620可以包括暴露在探针618的远端面626上的两个接触件622和624的双极阵列。接触件622和624可以具有大约1(一)mm到大约3mm的范围的直径并且可以突出远端面1(一)mm或更少。在远端面626上的接触件622与624之间的间距可以是大约1(一)mm到大约4mm。接触件622和624的边缘理想地是圆形，以便不损伤组织。接触件622和624的小区域确保将刺激附近可兴奋组织的高的电流密度。Electrode assembly 620 (see FIG. 18A ) is sized and configured to accurately identify tissue regions innervated by target nerves. Electrode assembly 620 may be configured like something like a dental mirror and may have a diameter in the range of about 10 mm to about 15 mm. Assembly 620 may be slightly offset (eg, 10 degrees to 50 degrees) from probe 618 to provide ease of use and a more ergonomic configuration. Electrode assembly 620 may include a bipolar array of two contacts 622 and 624 exposed on a distal face 626 of stylet 618 . The contacts 622 and 624 may have a diameter ranging from about 1 (one) mm to about 3 mm and may protrude from the distal face by 1 (one) mm or less. The spacing between the contacts 622 and 624 on the distal face 626 may be about 1 (one) mm to about 4 mm. The edges of contacts 622 and 624 are ideally rounded so as not to damage tissue. The small area of contacts 622 and 624 ensures a high current density that will stimulate nearby excitable tissue.
应该理解的是用于电极组件的其它构造可以是可能的。例如，图18B和图18C示出了两个另外可能的构造。图18B示出了具有暴露在探针618的远端面646上的接触件642和644的电极组件640。接触件642和644周向地隔开180度。如示出的，接触件642和644暴露在探针618的远端面646上，每个都占据探针618的远端面646的周边的大约90度到大约95度。接触件642和644还理想地沿着探针向近端地延伸大约5mm，并且突出超过探针618的远端面646短的距离，例如1mm。在远端面646上的接触件642与644之间的间距可以是大约1(一)mm到大约4mm。接触件642和644的边缘理想地是圆形，以便不损伤组织。图3C示出了环形电极组件，此环形电极组件具有暴露在探针618的远端面656上的外接触件652与内接触件654。外接触件652还可以沿着探针向近端地延伸。It should be understood that other configurations for the electrode assembly may be possible. For example, Figures 18B and 18C illustrate two additional possible configurations. FIG. 18B shows electrode assembly 640 with contacts 642 and 644 exposed on distal face 646 of stylet 618 . Contacts 642 and 644 are circumferentially spaced 180 degrees apart. As shown, the contacts 642 and 644 are exposed on the distal face 646 of the stylet 618 , each occupying about 90 degrees to about 95 degrees of the perimeter of the distal face 646 of the stylet 618 . The contacts 642 and 644 also desirably extend proximally about 5 mm along the probe and protrude beyond the distal face 646 of the probe 618 a short distance, eg, 1 mm. The spacing between the contacts 642 and 644 on the distal face 646 may be about 1 (one) mm to about 4 mm. The edges of contacts 642 and 644 are ideally rounded so as not to damage tissue. FIG. 3C shows a ring electrode assembly having outer contacts 652 and inner contacts 654 exposed on a distal face 656 of stylet 618 . The outer contact 652 may also extend proximally along the stylet.
接触件622和624(以及它们的另选实施方式)可以包括例如不锈钢、银、铂、或者通过铂黑处理的铂。探针618尤其在其远端面626处包括优选地通过血液、盐水与体液润湿不良的塑料材料，以使当不存在直接组织接触时通过流体路径的经过电流的风险最小化。利用通常的绝缘装置(例如，线绝缘、垫圈、垫片、间隔件、衬套等)使探针618与把手616绝缘。Contacts 622 and 624 (and their alternative embodiments) may comprise, for example, stainless steel, silver, platinum, or platinum treated with platinum black. Probe 618 comprises, particularly at its distal face 626 , a plastic material that is preferably poorly wetted by blood, saline and body fluids, to minimize the risk of passing current through the fluid path when there is no direct tissue contact. The probe 618 is insulated from the handle 616 using conventional insulating means (eg, wire insulation, washers, spacers, spacers, bushings, etc.).
另选地，可以使用单极布置。在此实施方式中，必须提供返回电极(或者无关电极)以提供从身体返回到装置的电路径。返回电极可以布置在完整皮肤的表面上(例如，表面电极，诸如用于外科手术过程中的ECG监控)或者其可以是针状并且布置在外科手术区域或者穿过完整皮肤。Alternatively, a single pole arrangement may be used. In this embodiment, a return electrode (or extraneous electrode) must be provided to provide an electrical path from the body back to the device. The return electrode can be placed on the surface of the intact skin (eg, a surface electrode, such as used for ECG monitoring during surgery) or it can be needle-shaped and placed in the surgical field or through the intact skin.
电刺激控制电路628承载在把手616(参见图17A和图17B)内。控制电路628产生通过接触件622和624施加的刺激电流。通过定位在把手616内的原电池(用于单次使用应用)驱动控制电路628。如果此装置不用于单次使用，那么电池可以是可充电的。Electrical stimulation control circuitry 628 is carried within handle 616 (see FIGS. 17A and 17B ). Control circuit 628 generates a stimulation current that is applied through contacts 622 and 624 . Control circuit 628 is powered by a primary battery (for single use applications) positioned within handle 616 . If the device is not intended for single use, the battery may be rechargeable.
控制电路628理想地包括承载嵌入代码的板上、可编程微处理器。此代码表达了用于产生期望的电刺激波形的预编程规则或算法。在代表性实施方式中，刺激频率是20Hz，(尽管频率可以是可调节的，例如3Hz到100Hz)，并且此波形包括电荷平衡双相波形(即，没有净DC电流流动)。Control circuitry 628 ideally includes an on-board, programmable microprocessor carrying embedded code. This code expresses pre-programmed rules or algorithms for generating desired electrical stimulation waveforms. In a representative embodiment, the stimulation frequency is 20 Hz, (although the frequency may be adjustable, eg, 3 Hz to 100 Hz), and this waveform comprises a charge-balancing biphasic waveform (ie, no net DC current flows).
可以通过方便地承载在把手616上的控制器调节控制电路628的其它操作参数。Other operating parameters of the control circuit 628 may be adjusted by a controller conveniently carried on the handle 616 .
在示出的实施方式中(参见图17A),通过把手616的近端附近或近端上的旋转开关630或轮调节刺激幅度与刺激脉冲持续时间。旋转控制开关630理想地具有用于识别多个设定选择的标签。例如，前几个设置可以包括不同的幅度，每个幅度都具有相同的固定脉冲持续时间。其它设置可以提供包括幅度与脉冲持续期间的特定组合的一系列可选择设定。旋转控制开关630还理想地具有当从一个设置移动到下一个时为临床医生提供良好触觉反馈的棘爪。标记的刺激设定的范围可以包括，例如关闭、等待、以100μsec的1.5mA、以100μsec的3mA、以100μsec的5mA、以300μsec的5mA、以及以500μsec的10mA。In the illustrated embodiment (see FIG. 17A ), the stimulation amplitude and stimulation pulse duration are adjusted by a rotary switch 630 or wheel near or on the proximal end of the handle 616. The rotary control switch 630 desirably has labels for identifying the multiple setting selections. For example, the first few settings could include different amplitudes, each with the same fixed pulse duration. Other settings may provide a range of selectable settings including specific combinations of amplitude and pulse duration. The rotary control switch 630 also desirably has a detent that provides the clinician with good tactile feedback when moving from one setting to the next. Ranges of labeled stimulus settings may include, for example, off, wait, 1.5 mA at 100 μsec, 3 mA at 100 μsec, 5 mA at 100 μsec, 5 mA at 300 μsec, and 10 mA at 500 μsec.
例如通过拇指使用的例如在壳体616的侧面上的瞬时按钮632控制通过接触件622和624的刺激电流的传送。瞬时按钮632允许第一系统612被控制，例如仅通过一只手打开与关闭刺激电流。仅如果按压瞬时按钮632，刺激电流传送通过接触件622和624(在通过旋转开关630设定的幅度/持续期间处)。如果不按压按钮632，就不传送刺激电流。Momentary button 632 , eg, on the side of housing 616 , used eg by the thumb, controls delivery of stimulation current through contacts 622 and 624 . The momentary button 632 allows the first system 612 to be controlled, for example turning stimulation current on and off with just one hand. Stimulation current is delivered through contacts 622 and 624 (at the amplitude/duration set by rotary switch 630 ) only if momentary button 632 is pressed. If button 632 is not pressed, no stimulation current is delivered.
在另选实施方式(参见图17B),可以通过把手616上的可调节阶梯滑动开关634调节刺激脉冲持续期间。由此，如果按压瞬时按钮632，就以规定的幅度与规定的持续时间施加刺激电流。如果不按压按钮632，就不传送刺激电流。滑动开关634理想地具有标签以识别选定的脉冲持续时间。滑动开关634理想地还具有棘爪，当从一个脉冲持续期间等级移动到下一个时，此棘爪为临床医生提供了良好的触觉反馈。标记的脉冲持续期间设定的范围可以包括例如，关闭、100μsec、300μsec、或500μsec。滑动开关634还可以具有标识的等待位置。In an alternative embodiment (see FIG. 17B ), the stimulation pulse duration can be adjusted via an adjustable stepped slide switch 634 on the handle 616. Thus, if the momentary button 632 is pressed, a stimulating current is applied at a prescribed amplitude and for a prescribed duration. If button 632 is not pressed, no stimulation current is delivered. Slide switch 634 desirably has a label to identify the selected pulse duration. The slide switch 634 desirably also has a detent that provides the clinician with nice tactile feedback when moving from one pulse duration level to the next. Ranges set for the pulse duration of the marker may include, for example, off, 100 μsec, 300 μsec, or 500 μsec. Slide switch 634 may also have an identified wait position.
另选地，如果未提供脉冲持续期间滑动开关634，并且不是经由旋转控制开关630选择脉冲持续期间，那么刺激脉冲持续期间可以固定在标定的选定持续期间，例如250μsec。Alternatively, if the pulse duration slide switch 634 is not provided, and the pulse duration is not selected via the rotary control switch 630, the stimulation pulse duration may be fixed at a nominal selected duration, eg, 250 μsec.
控制电路628期望地包括光指示，即在把手上的发光二极管LED638，其为外科医生提供了多种指示。例如，LED638可以确认电池状态与刺激器开/关状态。此外理想的是，当足够刺激被传送时，LED638闪绿色，并且当不充足刺激被传送时，LED638闪红色。此外，仅如果实际传送的电流在要求幅度的期望百分比内，例如在要求值的25％内，LED638可以闪烁或发光。控制电路628由此给临床医生提供了关于要求传送的刺激电流的可靠反馈。Control circuit 628 desirably includes light indicators, ie light emitting diodes LED 638 on the handle, which provide various indications to the surgeon. For example, LED 638 can confirm battery status and stimulator on/off status. Also ideally, the LED 638 flashes green when sufficient stimulus is delivered, and flashes red when insufficient stimulus is delivered. Additionally, LED 638 may blink or illuminate only if the actual delivered current is within a desired percentage of the requested magnitude, eg, within 25% of the requested value. The control circuit 628 thus provides reliable feedback to the clinician regarding the stimulation current required to be delivered.
在另选实施方式中，仅当传送刺激电流时，控制电路628还可以产生声学音调。通过在把手616上的指示器636传送音调。In an alternative embodiment, the control circuit 628 may also generate acoustic tones only when a stimulating current is being delivered. The tone is delivered through an indicator 636 on the handle 616 .
通过使用不同的音调、颜色、不同的闪光率等，控制电路628可以允许临床医生确认探针与组织接触、此装置打开、电池具有足够功率、以及刺激电流流动。由此临床医生对于不能引起期望的反应是因为在探针的尖端附近缺少可见神经组织而不是不能使电极连接件的故障或者一些其它装置的问题具有更大的信心。By using different tones, colors, different flash rates, etc., the control circuit 628 can allow the clinician to confirm that the probe is in contact with tissue, that the device is on, that the battery has sufficient power, and that stimulation current is flowing. The clinician thus has greater confidence that the failure to elicit the desired response is due to a lack of visible neural tissue near the tip of the probe, rather than failure of the electrode connection or some other device problem.
B.第二装置B. Second device
根据目标组织区域的生理功能以及基于通过第一系统612施加的电刺激电流预期的生理反应的属性和特征，第二系统614可以采用多种形式。The second system 614 may take a variety of forms depending on the physiological function of the target tissue region and the nature and characteristics of the physiological response expected based on the electrical stimulation current applied through the first system 612 .
例如，影响呼吸活动的副交感神经的电刺激致使呼吸缓慢。由此，当期望区分和/或识别影响呼吸活动的副交感神经的存在与否时，呼吸速率的减小可以用作预期的生理反应。在此布置中，第二系统614可以包括监控呼吸的装置。此装置可以包括例如胸部位置传感器与监控胸部的运动的肺活量计箱。此装置还可以包括穿戴在胸部周围的呼吸传感器，诸如呼吸(伸展)传感器或者胸动描记器。通过第二装置探测的呼吸速率的减小指示第一装置定位在副交感神经处或副交感神经附近。For example, electrical stimulation of the parasympathetic nerves that affect respiratory activity results in slow breathing. Thus, when it is desired to differentiate and/or identify the presence or absence of parasympathetic influences on respiratory activity, a reduction in breathing rate can be used as an expected physiological response. In this arrangement, the second system 614 may include means to monitor respiration. This device may include, for example, a chest position sensor and a spirometer box that monitors the movement of the chest. The device may also include a respiration sensor worn around the chest, such as a respiration (stretch) sensor or a thoracograph. A decrease in respiration rate detected by the second device indicates that the first device is positioned at or near the parasympathetic nerve.
作为另一个实例，影响心脏功能的副交感神经的刺激增加了静息电位并且减小了舒张除极的速率。在这些情形下心脏速率减慢。由此，当期望区分和/或识别影响心脏活动的副交感神经的存在与否时，心脏速率可以用作预期的生理反应。在此布置中，第二系统614可以包括心电图(EKG)装置。As another example, stimulation of the parasympathetic nerves that affect cardiac function increases the resting potential and decreases the rate of diastolic depolarization. In these situations the heart rate slows down. Thus, heart rate can be used as the expected physiological response when it is desired to differentiate and/or identify the presence or absence of parasympathetic nerves affecting cardiac activity. In this arrangement, the second system 614 may include an electrocardiogram (EKG) device.
作为另一个实例，影响消化的副交感神经的刺激(例如，在胃液分泌的头期期间)调节反射胃液分泌。由此，当期望区分和/或识别影响胃活动的副交感神经的存在与否时，胃液分泌的减少可以用作预期的生理反应。在此布置中，第二系统614可以包括传感胃液分泌的装置。As another example, stimulation of parasympathetic nerves that affect digestion (eg, during the cephalic phase of gastric secretion) modulates reflex gastric secretion. Thus, when it is desired to differentiate and/or identify the presence or absence of parasympathetic nerves affecting gastric motility, the reduction in gastric juice secretion can be used as an expected physiological response. In this arrangement, the second system 614 may include a device for sensing the secretion of gastric juice.
作为另一个实例，第二系统614可以包括肌电图(EMG)装置。EMG装置测量肌肉内的神经脉冲。EMG系统包括布置在受到副交感神经支配的组织中的肌肉中的电极，并且可以利用显示电流的运动的装置(例如示波器)观察对第一系统612的操作的电响应。当肌肉收缩时，它们发射可以作为预期的生理反应探测、放大与跟踪的弱的电信号。As another example, the second system 614 may include an electromyography (EMG) device. An EMG device measures nerve impulses in the muscles. The EMG system includes electrodes disposed in muscles in tissue innervated by parasympathetic nerves, and the electrical response to the operation of the first system 612 can be observed with a device that shows the movement of the current, such as an oscilloscope. When muscles contract, they emit weak electrical signals that can be detected, amplified and tracked as expected physiological responses.
III.系统的使用III. Use of the system
在使用中，第一系统612定位为与在目标组织区域TR中的组织接触。临床医生可以通过一只手操作第一系统612以施加刺激电流。临床医生的另一只手然后必要时可以对刺激电流进行调节。第二系统614监控生理反应。第一系统612定位并且再定位(如果必要的话)，直到通过第二系统614指示的监控的生理反应与期望的生理反应匹配或接近。这指示目标神经纤维或分支的存在，并且然后可以标记识别的位置。然后可以执行期望的治疗方案，例如为了疗效操纵副交感神经系统。In use, the first system 612 is positioned in contact with tissue in the target tissue region TR. The clinician can operate the first system 612 with one hand to apply stimulation current. The clinician's other hand can then make adjustments to the stimulation current if necessary. The second system 614 monitors the physiological response. The first system 612 positions and repositions (if necessary) until the monitored physiological response indicated by the second system 614 matches or approximates the desired physiological response. This indicates the presence of the target nerve fiber or branch, and the identified location can then be marked. A desired therapeutic regimen can then be implemented, such as manipulating the parasympathetic nervous system for therapeutic effect.
例如，在无需组织消融以及无需生理性传导中断的情况下，已经观察到心脏的副交感神经系统可以操纵为与心脏传导配合和/或用作与心房颤动相关。已知迷走神经的副交感神经纤维可以操纵为影响心脏周期长度。还已知的是迷走神经的副交感神经纤维选择性地支配神经心外膜房室(AV)结脂肪垫和窦房(SA)结脂肪垫(如图20所示)。For example, it has been observed that the parasympathetic nervous system of the heart can be manipulated to coordinate cardiac conduction and/or act in connection with atrial fibrillation without tissue ablation and without physiological conduction interruption. The parasympathetic fibers of the vagus nerve are known to be manipulated to affect cardiac cycle length. It is also known that the parasympathetic fibers of the vagus nerve selectively innervate the epicardial atrioventricular (AV) node fat pad and the sinoatrial (SA) node fat pad (as shown in Figure 20).
系统610使得能够例如区分与识别在心脏的表面上的心外膜房室结脂肪垫，并且由此使得为了疗效能够在此位置处进入心脏的副交感神经系统。The system 610 enables, for example, the differentiation and identification of the epicardial atrioventricular node fat pad on the surface of the heart, and thereby enables access to the parasympathetic nervous system of the heart at this location for therapeutic effect.
更具体地说，系统610的第一系统612使得将高度局部化的电刺激施加在心脏的表面上，同时第二系统614监控心脏速率。临床医生可以启动以最低幅度设定施加刺激电流并如必要时增加幅度设定。由于患者与患者的组织区域的生理差异，调节可能是必要的。在组织区域TR的视觉检查指示较高初始设置可能是必须的以后，临床医生还可以开始以除了最低幅度设置的某设置施加刺激电流。More specifically, a first system 612 of systems 610 enables highly localized electrical stimulation to be applied to the surface of the heart while a second system 614 monitors heart rate. The clinician can initiate application of stimulation current at the lowest amplitude setting and increase the amplitude setting if necessary. Adjustments may be necessary due to patient-to-patient physiological differences in tissue regions. The clinician may also begin applying stimulation current at a setting other than the lowest amplitude setting after visual inspection of the tissue region TR indicates that a higher initial setting may be necessary.
当第一系统612施加刺激并且最终地定位在房室结脂肪垫(参见图22)的区域处或房室结脂肪垫附近时，心率(通过例如EKG装置的第二系统614监控)将减小。EKG装置614将通过在EKG上观察到的R到R间距的增加指示心率的降低(将图21中示出的R到R间距与图22中示出的增加的R到R间距进行比较)。临床医生然后可以停止将刺激电流施加到组织区域，例如识别的房室结脂肪垫，并且观察心率增加返回到初始心率(在EKG上观察到的R到R中的减小)。临床医生可以经历施加刺激电流、观察R到R间距的增加、停止刺激电流的施加、以及观察R到R间距减小的步骤，以确认目标组织区域，例如房室结脂肪垫的准确位置。通过此种方式，系统610允许外科医生将房室结脂肪垫(以及受副交感神经选择性地支配的其它区域)系统地并且准确地定位在心脏的表面上。When the stimulus is applied by the first system 612 and eventually localized at or near the region of the atrioventricular nodal fat pad (see FIG. 22 ), the heart rate (monitored by the second system 614, such as an EKG device) will decrease . The EKG device 614 will indicate a decrease in heart rate by an increase in the R to R spacing observed on the EKG (compare the R to R spacing shown in FIG. 21 with the increased R to R spacing shown in FIG. 22). The clinician can then stop applying the stimulating current to the tissue region, such as the identified AV node fat pad, and observe the heart rate increase back to the initial heart rate (decrease in R to R observed on the EKG). A clinician may go through the steps of applying a stimulating current, observing an increase in the R-to-R spacing, stopping application of the stimulating current, and observing a decrease in the R-to-R spacing to confirm the exact location of the target tissue area, such as the atrioventricular node fat pad. In this way, the system 610 allows the surgeon to systematically and accurately locate the AV node fat pad (and other regions selectively innervated by parasympathetic nerves) on the surface of the heart.
一旦定位，临床医生可以使用第一系统612来施加冲模或其它标记其以保持房室结脂肪垫的识别。另选地，单独的施加器可以用于施加冲模或者其它标记，或者临床医生可以随着他们的手指使用视觉技巧，例如，以保持房室结脂肪垫的识别。临床医生然后为了疗效可以采取扰动心脏的副交感神经系统的步骤。例如，通过由系统610定位的房室结脂肪垫的电操纵或非电操纵，临床医生可以治疗或防止不受控的心房颤动或者执行其它期望治疗，或者临床医生可以应用提供房室结率的生理控制的闭合环路反馈控制算法。Once located, the clinician can use the first system 612 to apply a stamp or other marker to keep the AV node fat pad identified. Alternatively, a separate applicator can be used to apply a die or other marker, or the clinician can use a visual trick with their fingers, for example, to keep the atrioventricular node fat pad identified. The clinician may then take the step of perturbing the parasympathetic nervous system of the heart for therapeutic effect. For example, through electrical or non-electrical manipulation of the AV nodal fat pad localized by the system 610, the clinician can treat or prevent uncontrolled atrial fibrillation or perform other desired treatments, or the clinician can apply a Closed-loop feedback control algorithm for physiological control.
通过系统610定位的房室结脂肪垫的操纵保持生理性传导。通过电操纵，其有益的效果可以同时地打开与关闭，并且没有效果的衰减。房室结脂肪垫的操纵可以在心房颤动的治疗中提供房室结脂肪消融的可行另选，这不保持生理性传导并且替代地使患者托付到心脏起搏依赖。Manipulation of the atrioventricular node fat pad located by the system 610 maintains physiological conduction. By electrical manipulation, its beneficial effects can be turned on and off simultaneously, with no attenuation of effect. Manipulation of the AV node fat pad may provide a viable alternative to AV node fat ablation in the treatment of atrial fibrillation, which does not preserve physiologic conduction and instead commits the patient to cardiac pacing dependence.
适配器设计adapter design
在实施方式中,系统20可以构造为容纳适配器。适配器可以构造为连接到系统20的一部分，诸如到刺激探针50。此适配器可以提供其它功能、使用性、以及刺激探针50的控制。In embodiments, system 20 may be configured to accommodate adapters. An adapter may be configured to connect to a portion of system 20 , such as to stimulation probe 50 . This adapter can provide additional functionality, usability, and control of stimulation probe 50 .
在实施方式中,如图23-图29中所示，适配器可以是双极适配器710。适配器可以构造为附接到控制装置22，诸如刺激探针50以允许此装置用作具有上述双极装置的全部功能的双极装置。In an embodiment, the adapter may be a bipolar adapter 710 as shown in FIGS. 23-29 . An adapter may be configured to attach to a control device 22, such as a stimulation probe 50, to allow the device to be used as a bipolar device with full functionality of the bipolar devices described above.
双极适配器710可以用于单极刺激装置以提供更加准确的刺激控制。具体地说，双极适配器710可以提供除了刺激探针50的基本操作元件110的返回元件716，以限定刺激电场并且将刺激引导到诸如目标神经的特定期望位置。返回元件716可以包括线或任何其它绝缘电导体并且可以包括用于与目标组织进行电接触的尖端或电极718。A bipolar adapter 710 can be used with a monopolar stimulation device to provide more accurate stimulation control. Specifically, the bipolar adapter 710 may provide a return element 716 in addition to the base operative element 110 of the stimulation probe 50 to define the stimulation electric field and direct stimulation to a specific desired location, such as a target nerve. The return element 716 may include a wire or any other insulated electrical conductor and may include a tip or electrode 718 for making electrical contact with the target tissue.
在实施方式中，适配器710可以包括连接器712。连接器712可以是任何适当的尺寸与形状，诸如如在图23和图24中所示的大体上是细长的。连接器712可以通常地是锥形以便在手术过程中不阻挡使用者的视线。连接器712可以构造为连接到刺激探针50。例如，连接器可以包括用于将刺激探针50的操作元件110的一部分容纳在其中的开口714。开口714可以延伸通过连接器712的一部分或全部。开口714的尺寸与形状可以设计为将操作元件110容纳在其中。例如，操作元件110可以从连接器712的第一端延伸通过开口并且在连接器712的第二端或相对端突出通过开口714。可以暴露操作元件110的传导部分以允许电流流动到目标组织。In an embodiment, the adapter 710 may include a connector 712 . Connector 712 may be of any suitable size and shape, such as being generally elongated as shown in FIGS. 23 and 24 . Connector 712 may be generally tapered so as not to obstruct the user's view during the procedure. Connector 712 may be configured to connect to stimulation probe 50 . For example, the connector may include an opening 714 for receiving a portion of the operative element 110 of the stimulation probe 50 therein. Opening 714 may extend through part or all of connector 712 . The opening 714 may be sized and shaped to accommodate the operating element 110 therein. For example, the operative element 110 may extend from a first end of the connector 712 through the opening and protrude through the opening 714 at a second or opposite end of the connector 712 . Conductive portions of the operative element 110 may be exposed to allow electrical current to flow to the target tissue.
开口714可以构造为将操作元件110保持在适当位置处。例如开口714可以成锥形以将探针保持在压配合中。开口714可以进一步构造为包括定位螺钉或其它保持特征以将操作元件110保持在期望位置处。The opening 714 may be configured to hold the operating element 110 in place. For example the opening 714 may be tapered to keep the probe in a press fit. The opening 714 may be further configured to include set screws or other retention features to retain the operative element 110 in a desired position.
连接器712可以包括第二探针或返回元件716。如图25中所示，返回操作元件716可以与开口714隔开特定距离D。可以从开口714的中心到返回元件716的中心测量距离D，并且距离D可以而是任何适当距离，诸如2毫米、1毫米、或者任何其它适当距离。Connector 712 may include a second probe or return element 716 . As shown in FIG. 25 , return operative element 716 may be spaced a certain distance D from opening 714 . Distance D may be measured from the center of opening 714 to the center of return element 716 and may be any suitable distance, such as 2 mm, 1 mm, or any other suitable distance.
返回元件716可以是任何适当直径。例如，刺激探针50操作元件110可以具有大约0.04英寸的直径。返回元件716可以具有较小直径，诸如0.02英寸，或者任何其它适当直径。Return element 716 may be of any suitable diameter. For example, stimulation probe 50 operative element 110 may have a diameter of approximately 0.04 inches. Return element 716 may have a smaller diameter, such as 0.02 inches, or any other suitable diameter.
双极适配器710还可以包括从连接器710延伸的超软细股线720。超软细股线720可以是任何适当长度并且可以构造为电接地或者任何适当电路。例如，超软细股线720可以在一端包括连接器722以容纳鲁尔连接件或者其它电连接件。The bipolar adapter 710 may also include an ultra-soft thin strand 720 extending from the connector 710 . The ultrasoft strands 720 may be of any suitable length and may be configured as an electrical ground or any suitable electrical circuit. For example, the ultrasoft thin strand 720 may include a connector 722 at one end to accommodate a Luer connector or other electrical connection.
在图26中示出的实施方式中，连接器712可以构造为直接地容纳来自返回操作元件的电连接件。例如，连接器712可以在用于容纳操作元件110的开口714附近包括柱塞724。柱塞724可以容纳鲁尔连接器或者任何其它适当的电连接件。柱塞724可以与返回元件716成电连接。In the embodiment shown in FIG. 26, connector 712 may be configured to directly receive an electrical connection from the return operative element. For example, connector 712 may include plunger 724 adjacent opening 714 for receiving operative element 110 . The plunger 724 may accommodate a Luer connector or any other suitable electrical connection. The plunger 724 may be in electrical communication with the return element 716 .
在实施方式中，双极适配器710可以布置为夹紧或卡合在刺激探针50上。适配器710可以包括具有绝缘部分730与暴露部分732的返回元件716。适配器710还可以包括用于将返回元件716连接到刺激探针50的一个或多个夹具。例如，如图27中所示，适配器710可以包括布置为连接到刺激探针50的本体或壳体的第一夹具734。另外的夹具736可以布置为连接到刺激探针50的操作元件110。其它夹具736可以允许返回元件716跟随操作元件110的路径以防止对使用者视线的任何妨碍。适配器710可以包括连接到返回元件716的接收件738。接收件738可以构造为接收电连接器，诸如鲁尔连接器，以在返回元件716上提供接地或者其它电信号。In an embodiment, the bipolar adapter 710 may be arranged to clip or snap onto the stimulation probe 50 . Adapter 710 may include a return element 716 having an insulating portion 730 and an exposed portion 732 . Adapter 710 may also include one or more clips for connecting return element 716 to stimulation probe 50 . For example, as shown in FIG. 27 , the adapter 710 may include a first clamp 734 arranged to connect to the body or housing of the stimulation probe 50 . A further clamp 736 may be arranged to be connected to the operative element 110 of the stimulation probe 50 . Other clips 736 may allow the return element 716 to follow the path of the operating element 110 to prevent any obstruction of the user's view. Adapter 710 may include a receiver 738 connected to return element 716 . Receptacle 738 may be configured to receive an electrical connector, such as a luer connector, to provide a ground or other electrical signal on return element 716 .
在实施方式中，如图28和图29中所示，适配器710可以包括单个单元夹具740。单元夹具740可以设计为容纳适配器的返回元件716与刺激探针50的操作元件110。In an embodiment, as shown in FIGS. 28 and 29 , the adapter 710 may include a single unit clamp 740 . The unit holder 740 may be designed to accommodate the return element 716 of the adapter and the operative element 110 of the stimulation probe 50 .
单元夹具740可以包括第一通道742与第二通道744。第一通道742可以构造为将主要操作元件110容纳在其中，并且第二通道744可以构造为将返回元件716容纳在其中。通道可以大体上是圆形或者具有大体上圆形或半圆形横截面，或者任何适当形状以保持与保留元件110、716。此通道可以具有不同直径以适合电极110、716的不同直径。例如，第一通道742可以构造为容纳具有大约0.04英寸的直径的元件，同时第二通道可以构造为容纳具有大约0.02英寸的直径的元件。如图28和图29中所示，通道742、744可以是不同的长度。例如，第一通道742可以较长并且延伸到操作元件110的基部，同时第二通道744可能较短并且可以允许返回元件716远离刺激探针50的本体延伸。The unit fixture 740 may include a first channel 742 and a second channel 744 . The first channel 742 may be configured to receive the primary operating element 110 therein, and the second channel 744 may be configured to receive the return element 716 therein. The channels may be generally circular or have a generally circular or semi-circular cross-section, or any suitable shape to hold and retain the elements 110,716. This channel may have different diameters to suit the different diameters of the electrodes 110,716. For example, the first channel 742 may be configured to accommodate elements having a diameter of approximately 0.04 inches, while the second channel may be configured to accommodate elements having a diameter of approximately 0.02 inches. As shown in Figures 28 and 29, the channels 742, 744 may be of different lengths. For example, the first channel 742 may be longer and extend to the base of the operative element 110 , while the second channel 744 may be shorter and may allow the return element 716 to extend away from the body of the stimulation probe 50 .
操作元件110可以定位在第一通道742中，使得操作元件110的尖端111延伸超过单元夹具740的端部。同样地，返回操作元件716可以定位在第二通道744中，使得返回操作元件716的尖端718延伸超过单元夹具740的端部。The operative element 110 may be positioned in the first channel 742 such that the tip 111 of the operative element 110 extends beyond the end of the unit clamp 740 . Likewise, the return operative element 716 may be positioned in the second channel 744 such that the tip 718 of the return operative element 716 extends beyond the end of the unit clamp 740 .
单元夹具740可以弯曲或成角度。例如，如图28和图29中所示，单元夹具可以包括第一部分750与远离第一部分成角度的弯曲部分752。弯曲部分752的角度可以设计为沿着操作元件110的角度并且与操作元件110的角度匹配。弯曲部分752可以相对于保持刺激探针50的使用者向下地成角度以防止任何视觉障碍并且允许使用者保持清晰视线。The unit clamp 740 may be curved or angled. For example, as shown in FIGS. 28 and 29 , the unit clamp may include a first portion 750 with a curved portion 752 angled away from the first portion. The angle of the curved portion 752 can be designed to follow and match the angle of the operating element 110 . The curved portion 752 may be angled downward relative to the user holding the stimulation probe 50 to prevent any visual obstruction and allow the user to maintain a clear line of sight.
适配器710可以包括连接到返回操作元件716的接收件746。接收件746可以构造为将诸如针或鲁尔连接器的电连接件容纳在其中。接收件746可以允许返回操作元件716连接到电接地或者完成刺激探针50的电路。Adapter 710 may include a receiver 746 that connects to return operative element 716 . Receptacle 746 may be configured to receive an electrical connection therein, such as a pin or luer connector. Receptacle 746 may allow return operative element 716 to be connected to electrical ground or to complete the electrical circuit of stimulation probe 50 .
上面实施方式的任一个中描述的夹具都可以是可调节的。例如，夹具可以是可锻的、可滑动的、或者另外地可移动的以允许选择性地调节操作元件尖端111与返回元件尖端718之间的距离。使用者可以调节夹具以实现用于给定应用的期望距离。The clamps described in any of the above embodiments may be adjustable. For example, the clamp may be malleable, slidable, or otherwise movable to allow selective adjustment of the distance between the operating element tip 111 and the return element tip 718 . A user can adjust the clamps to achieve the desired distance for a given application.
在实施方式中，如图30中所示，适配器可以是经皮适配器810。经皮适配器810可以构造为允许刺激探针50在目标患者的皮肤下方传送刺激信号。In an embodiment, the adapter may be a percutaneous adapter 810 as shown in FIG. 30 . Transcutaneous adapter 810 may be configured to allow stimulation probe 50 to deliver stimulation signals beneath the skin of a target patient.
经皮适配器810可以包括连接器812。连接器812可以构造为连接到刺激探针50的操作元件110。例如，连接器可以包括用于将操作元件110容纳在其中的开口814。开口814可以是锥形的以使操作元件110以压配合保持在连接器812内。连接器还可以包括其它保持特征，诸如定位螺钉或夹具，以保持连接器812与操作元件110之间的连接。Transcutaneous adapter 810 may include connector 812 . The connector 812 may be configured to be connected to the operating element 110 of the stimulation probe 50 . For example, the connector may include an opening 814 for receiving the operating element 110 therein. Opening 814 may be tapered to retain operative element 110 within connector 812 with a press fit. The connector may also include other retention features, such as set screws or clips, to maintain the connection between the connector 812 and the operative element 110 .
经皮适配器810可以包括从连接器812延伸的引线816。引线816可以是与插入连接器812中的操作元件110电连接的电导体。导线816可以是任何适当长度，诸如24英寸或者12英寸与48英寸之间的长度。引线还可以进一步是任何适当的量规，诸如24AWG线。Transcutaneous adapter 810 may include leads 816 extending from connector 812 . The leads 816 may be electrical conductors electrically connected to the operating element 110 plugged into the connector 812 . The wire 816 may be any suitable length, such as 24 inches, or a length between 12 inches and 48 inches. The lead wires may further be any suitable gauge, such as 24AWG wire.
经皮适配器810可以包括连接到引线816的针820。针可以由诸如不锈钢的任何适当材料制成。优选地，针可以由导电材料制成并且与引线816电联通。护套822可以定位在针820的基部以确保引线816与针820之间的连接。针820的一部分可以是绝缘的。例如，针可以远离其尖端824达5毫米是绝缘的。针820的暴露尖端824可以将电刺激信号传送到皮肤表面以下的目标组织。Transcutaneous adapter 810 may include a needle 820 connected to lead wire 816 . The needles may be made of any suitable material such as stainless steel. Preferably, the needle may be made of a conductive material and be in electrical communication with the lead wire 816 . A sheath 822 may be positioned at the base of the needle 820 to secure the connection between the lead 816 and the needle 820 . A portion of needle 820 may be insulated. For example, the needle may be insulated up to 5 mm away from its tip 824 . The exposed tip 824 of the needle 820 can deliver electrical stimulation signals to target tissue below the surface of the skin.
上面仅说明性地视为本发明的原理。此外,由于本领域中技术人员将容易地想到多种修改与改变,因此不期望将本发明限定到示出与描述的精确构造与操作。尽管已经描述了优选实施方式，但是在不偏离由权利要求限定的本发明的情况下可以改变细节。The foregoing is considered as illustrative only of the principles of the invention. Furthermore, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described. While a preferred embodiment has been described, details may be changed without departing from the invention as defined by the claims.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201911232872.XACN111110345B (en) | 2012-09-20 | 2013-09-05 | Stimulation device adapter |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201213014452A | 2012-09-20 | 2012-09-20 | |
| US201313466485A | 2013-07-03 | 2013-07-03 | |
| PCT/US2013/058270WO2014088661A1 (en) | 2012-09-20 | 2013-09-05 | Stimulation device adapter |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201911232872.XADivisionCN111110345B (en) | 2012-09-20 | 2013-09-05 | Stimulation device adapter |
| Publication Number | Publication Date |
|---|---|
| CN105682593Atrue CN105682593A (en) | 2016-06-15 |
| CN105682593B CN105682593B (en) | 2019-12-31 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201380080719.4AActiveCN105682593B (en) | 2012-09-20 | 2013-09-05 | Stimulator Adapter |
| CN201911232872.XAActiveCN111110345B (en) | 2012-09-20 | 2013-09-05 | Stimulation device adapter |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201911232872.XAActiveCN111110345B (en) | 2012-09-20 | 2013-09-05 | Stimulation device adapter |
| Country | Link |
|---|---|
| CN (2) | CN105682593B (en) |
| AU (1) | AU2013356668A1 (en) |
| CA (3) | CA3210942A1 (en) |
| WO (1) | WO2014088661A1 (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111032146A (en)* | 2017-06-22 | 2020-04-17 | 赤克邦外科有限公司 | Nerve regeneration system and method |
| CN113348013A (en)* | 2018-11-08 | 2021-09-03 | 赤克邦外科股份有限公司 | System and method for neuroregenerative therapy |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US10154792B2 (en) | 2005-03-01 | 2018-12-18 | Checkpoint Surgical, Inc. | Stimulation device adapter |
| CN104771224A (en)* | 2015-04-09 | 2015-07-15 | 张彦 | Locating ablation pen for epicardial fat pad |
| US20190239945A1 (en)* | 2018-02-06 | 2019-08-08 | Biosense Webster (Israel) Ltd. | Catheter handle with ring color indicators |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020120259A1 (en)* | 1995-06-07 | 2002-08-29 | Lettice John J. | Methods for targeted electrosurgery on contained herniated discs |
| US20050187512A1 (en)* | 2004-02-06 | 2005-08-25 | Isola Scott S. | Ultrasonic probe with detachable slidable cauterization forceps |
| US20090054890A1 (en)* | 2007-08-23 | 2009-02-26 | Decarlo Arnold V | Electrosurgical device with LED adapter |
| CN101594830A (en)* | 2007-01-25 | 2009-12-02 | 华沙整形外科股份有限公司 | Surgical navigational and neuromonitoring instrument |
| CN101646395A (en)* | 2006-11-01 | 2010-02-10 | 博维医疗设备公司 | Bipolar ablation probe having porous electrodes for delivering electrically conductive fluid |
| US20110060242A1 (en)* | 2005-03-01 | 2011-03-10 | Checkpoint Surgical, Llc | Systems and methods for intra-operative stimulation within a surgical field |
| CN202920258U (en)* | 2012-11-19 | 2013-05-08 | 杭州诺尔康神经电子科技有限公司 | Electrode implantation probe |
| CN104321012A (en)* | 2012-04-25 | 2015-01-28 | 美敦力施美德公司 | Stimulation probe for robotic and laparoscopic surgery |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7112199B2 (en)* | 1996-09-20 | 2006-09-26 | Ioan Cosmescu | Multifunctional telescopic monopolar/bipolar surgical device and method therefore |
| GB9900964D0 (en)* | 1999-01-15 | 1999-03-10 | Gyrus Medical Ltd | An electrosurgical system |
| US7174218B1 (en)* | 2003-08-12 | 2007-02-06 | Advanced Bionics Corporation | Lead extension system for use with a microstimulator |
| US8002770B2 (en)* | 2003-12-02 | 2011-08-23 | Endoscopic Technologies, Inc. (Estech) | Clamp based methods and apparatus for forming lesions in tissue and confirming whether a therapeutic lesion has been formed |
| US10342452B2 (en)* | 2004-07-29 | 2019-07-09 | Medtronic Xomed, Inc. | Stimulator handpiece for an evoked potential monitoring system |
| US7678107B2 (en)* | 2005-03-10 | 2010-03-16 | Boston Scientific Scimed, Inc. | Medical needles and electrodes with improved bending stiffness |
| US7540871B2 (en)* | 2005-08-03 | 2009-06-02 | Conmed Corporation | Integrated three-port receptacle and method for connecting hand and foot switched electrosurgical accessories |
| US20070078454A1 (en)* | 2005-09-30 | 2007-04-05 | Mcpherson James W | System and method for creating lesions using bipolar electrodes |
| GB0526151D0 (en)* | 2005-12-22 | 2006-02-01 | Eschmann Holdings Ltd | Improvements in or relating to surgical instruments |
| US7976469B2 (en)* | 2007-06-04 | 2011-07-12 | Medtronic, Inc. | Percutaneous needle guide |
| US8479625B2 (en)* | 2009-01-21 | 2013-07-09 | Mark S. Klepper | Method to manufacture a tube sump with integral clips |
| US9168054B2 (en)* | 2009-10-09 | 2015-10-27 | Ethicon Endo-Surgery, Inc. | Surgical generator for ultrasonic and electrosurgical devices |
| US20130086773A1 (en)* | 2011-10-07 | 2013-04-11 | Coeur, Inc. | Surgical instrument packaging clip system |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20020120259A1 (en)* | 1995-06-07 | 2002-08-29 | Lettice John J. | Methods for targeted electrosurgery on contained herniated discs |
| US20050187512A1 (en)* | 2004-02-06 | 2005-08-25 | Isola Scott S. | Ultrasonic probe with detachable slidable cauterization forceps |
| US20110060242A1 (en)* | 2005-03-01 | 2011-03-10 | Checkpoint Surgical, Llc | Systems and methods for intra-operative stimulation within a surgical field |
| CN101646395A (en)* | 2006-11-01 | 2010-02-10 | 博维医疗设备公司 | Bipolar ablation probe having porous electrodes for delivering electrically conductive fluid |
| CN101594830A (en)* | 2007-01-25 | 2009-12-02 | 华沙整形外科股份有限公司 | Surgical navigational and neuromonitoring instrument |
| US20090054890A1 (en)* | 2007-08-23 | 2009-02-26 | Decarlo Arnold V | Electrosurgical device with LED adapter |
| CN104321012A (en)* | 2012-04-25 | 2015-01-28 | 美敦力施美德公司 | Stimulation probe for robotic and laparoscopic surgery |
| CN202920258U (en)* | 2012-11-19 | 2013-05-08 | 杭州诺尔康神经电子科技有限公司 | Electrode implantation probe |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111032146A (en)* | 2017-06-22 | 2020-04-17 | 赤克邦外科有限公司 | Nerve regeneration system and method |
| CN113348013A (en)* | 2018-11-08 | 2021-09-03 | 赤克邦外科股份有限公司 | System and method for neuroregenerative therapy |
| Publication number | Publication date |
|---|---|
| CA3210942A1 (en) | 2014-06-12 |
| AU2013356668A1 (en) | 2016-08-25 |
| CA2924050C (en) | 2021-11-02 |
| CN105682593B (en) | 2019-12-31 |
| CA2924050A1 (en) | 2014-06-12 |
| CA3129771C (en) | 2023-10-17 |
| CA3129771A1 (en) | 2014-06-12 |
| CN111110345B (en) | 2024-03-15 |
| WO2014088661A1 (en) | 2014-06-12 |
| CN111110345A (en) | 2020-05-08 |
| Publication | Publication Date | Title |
|---|---|---|
| US11576599B2 (en) | Stimulation device adapter | |
| JP5410297B2 (en) | Intraoperative stimulation system | |
| US20140371622A1 (en) | Systems and methods for intra-operative regional neural stimulation | |
| CA2538199C (en) | Systems and methods for intra-operative stimulation | |
| CN101528123B (en) | Systems and methods for differentiating and/or identifying tissue regions innervated by target nerves for diagnostic and/or therapeutic purposes | |
| US20110060242A1 (en) | Systems and methods for intra-operative stimulation within a surgical field | |
| JP2010515487A5 (en) | ||
| US20110054346A1 (en) | Systems and methods for Intra-operative semi-quantitative threshold neural response testing related applications | |
| US20120296442A1 (en) | Systems and methods for intra-operative physiological functional stimulation | |
| CN105682593B (en) | Stimulator Adapter | |
| CN111032146A (en) | Nerve regeneration system and method | |
| US20110060238A1 (en) | Systems and methods for intra-operative physiological functional stimulation | |
| US20240099632A1 (en) | Nerve stimulation patterns and device for detectability of nerve function and health | |
| WO2011103003A1 (en) | Systems and methods for intra-operative semi-quantitative threshold neural response testing |
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |