CN111743621A - An invasive electrode for irreversible electroporation of esophageal tumor tissue - Google Patents
An invasive electrode for irreversible electroporation of esophageal tumor tissue Download PDFInfo
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- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
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Abstract
Description
技术领域technical field
本发明涉及一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极The invention relates to an invasive electrode for irreversible electroporation treatment of esophageal tumor tissue
背景技术Background technique
不可逆电穿孔(irreversible electroporation,IRE)消融技术是利用高压脉冲电场作用于组织细胞,使细胞膜在电势的作用下产生穿孔,破坏细胞的稳态,从而使细胞死亡,主要用于肿瘤的治疗。IRE消融治疗的过程,主要是通过电极将高压脉冲作用于特定范围的组织,从而达到能够灭活肿瘤细胞而又对正常细胞不产生影响的目的。目前的电极主要分为针型电极和平板电极两种类型。Irreversible electroporation (IRE) ablation technology uses a high-voltage pulsed electric field to act on tissue cells, so that the cell membrane is perforated under the action of electric potential, destroying the homeostasis of cells, thereby causing cell death, and is mainly used for tumor treatment. The process of IRE ablation treatment is mainly to apply high-voltage pulses to a specific range of tissues through electrodes, so as to achieve the purpose of inactivating tumor cells without affecting normal cells. The current electrodes are mainly divided into two types: needle electrodes and flat electrodes.
针型电极如美国Angio Dynamics公司生产的NanoKnife纳米刀(Fritz S,SommerCM,Vollherbst D,et al.Irreversible electroporation of the pancreas isfeasible and safe in a porcine survival model.Pancreas.2015,44(5):791-798),将电极平行插入肿瘤组织中,通过改变电极的间距以及插入肿瘤组织的深度来控制作用范围的大小。平板电极则是将肿瘤组织置于上下平行的两个电极之间,仅对电极之间的组织进行消融(Rombouts SJE,van Dijck WPM,Nijkamp MW,et al.Clinical and pathologicaloutcomes after irreversible electroporation of the pancreas using twoparallel plate electrodes:a porcine model.HPB(Oxford).2017,19(12):1058-1065)。Needle electrodes such as NanoKnife (Fritz S, Sommer CM, Vollherbst D, et al. Irreversible electroporation of the pancreas isfeasible and safe in a porcine survival model. Pancreas. 2015,44(5):791- 798), the electrodes were inserted into the tumor tissue in parallel, and the size of the action range was controlled by changing the electrode spacing and the depth of insertion into the tumor tissue. The flat electrode is to place the tumor tissue between two parallel electrodes, and only ablate the tissue between the electrodes (Rombouts SJE, van Dijck WPM, Nijkamp MW, et al. Clinical and pathological outcomes after irreversible electroporation of the pancreas). using two parallel plate electrodes: a porcine model. HPB (Oxford). 2017, 19(12): 1058-1065).
目前,这两种电极主要用于肝脏、胰腺以及肾脏等实质性脏器肿瘤中,然而对于食管这种空腔脏器的应用较少,只报道过平板电极在食管组织上的应用(Neven K,van Es R,van Driel V,et al.Acute and Long-Term Effects of Full-Power ElectroporationAblation Directly on the Porcine Esophagus.Circ Arrhythm Electrophysiol.2017,10(5).pii:e004672)。且现有的两种电极有着明显的不足之处,一方面现有电极的应用需要暴露脏器以便于电极的布置,这样对患者创伤较大,肿瘤患者本身身体比较虚弱,各方面功能有所下降,因IRE消融而产生额外的创伤,对患者的恢复具有较大的影响;另外,现有的针型电极虽然还可以通过经皮穿刺,在超声或CT的实时监测下来进行放置,但此过程操作复杂,费时费力。而食管作为一种空腔脏器,有着特殊的解剖结构,位置较深,毗邻心脏等重要器官,仅用现有的电极进行IRE消融,有着很大的风险。另外,由于食管外层没有浆膜层,在进行有创消融处理时稍有不慎,也易引发创口愈合不良,食管瘘的发生等,引起不必要的伤害。目前现有的这两种方法在食管上应用都比较困难,而且均无法保证对食管IRE消融的无创。At present, these two electrodes are mainly used in tumors of solid organs such as liver, pancreas, and kidney. However, the application of hollow organs such as esophagus is less, and only the application of flat electrodes on esophageal tissue has been reported (Neven K. , van Es R, van Driel V, et al. Acute and Long-Term Effects of Full-Power ElectroporationAblation Directly on the Porcine Esophagus. Circ Arrhythm Electrophysiol. 2017, 10(5).pii:e004672). Moreover, the existing two electrodes have obvious shortcomings. On the one hand, the application of the existing electrodes needs to expose the organs to facilitate the arrangement of the electrodes, which is more traumatic to the patient, and the tumor patients themselves are relatively weak, and their functions are somewhat different. In addition, the existing needle electrodes can be placed under real-time monitoring by ultrasound or CT through percutaneous puncture. The process is complicated and time-consuming. As a hollow organ, the esophagus has a special anatomical structure, is deep, and is adjacent to important organs such as the heart. Only using the existing electrodes for IRE ablation has great risks. In addition, since there is no serosal layer in the outer layer of the esophagus, a little carelessness in the invasive ablation treatment can easily lead to poor wound healing and the occurrence of esophageal fistula, causing unnecessary injuries. The two existing methods are difficult to apply on the esophagus, and neither can guarantee the non-invasiveness of esophageal IRE ablation.
因此,根据食管的脏器特点,设计出应用于食管癌IRE消融的特有电极具有重大意义。Therefore, according to the organ characteristics of the esophagus, it is of great significance to design a unique electrode for IRE ablation of esophageal cancer.
发明内容SUMMARY OF THE INVENTION
本发明提供一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极以解决现有技术电极治疗食管癌操作复杂,创口愈合不良等技术问题。The invention provides an invasive electrode for irreversible electroporation treatment of esophageal tumor tissue to solve the technical problems such as complicated operation of electrodes for treating esophageal cancer and poor wound healing in the prior art.
一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极,包括:固定外壳、护套、电极护套、电极丝以及电极;An invasive electrode for irreversible electroporation treatment of esophageal tumor tissue, comprising: a fixed shell, a sheath, an electrode sheath, an electrode wire and an electrode;
所述固定外壳设置有牵拉机构,所述牵拉机构设置为可以相对于固定外壳位移,The fixed casing is provided with a pulling mechanism, and the pulling mechanism is arranged to be able to displace relative to the fixed casing,
所述护套设置为柔性护套,具有中空腔体,其一端连接所述固定外壳另一端连接所述电极护套;The sheath is configured as a flexible sheath with a hollow cavity, one end of which is connected to the fixed shell and the other end is connected to the electrode sheath;
所述电极护套具有容纳腔体,所述容纳腔体内可滑动的设置电极固定环,所述电级固定环的一端连接电极,另一端抵接一弹性元件的一端,所述弹性元件设置于容纳腔体内,其另一端抵接所述电极护套;The electrode sheath has an accommodating cavity, and an electrode fixing ring is slidably arranged in the accommodating cavity, one end of the electrode fixing ring is connected to the electrode, and the other end abuts one end of an elastic element, and the elastic element is arranged on the in the accommodating cavity, the other end of which abuts the electrode sheath;
所述电极丝穿过所述护套的中空腔体和所述电极护套的容纳腔体,其一端连接所述牵拉机构,另一端连接所述电极或者电级固定环。The electrode wire passes through the hollow cavity of the sheath and the accommodating cavity of the electrode sheath, one end of which is connected to the pulling mechanism, and the other end is connected to the electrode or the electrode fixing ring.
优选为,所述牵拉机构设置为嵌入至所述固定外壳中。Preferably, the pulling mechanism is configured to be embedded in the fixed housing.
优选为,所述护套、电极护套均设置为金属护套。Preferably, the sheath and the electrode sheath are both metal sheaths.
优选为,所述护套外层喷涂有派福林涂层。Preferably, the outer layer of the sheath is sprayed with a Pefolin coating.
优选为,所述弹性元件设置为压缩弹簧。Preferably, the elastic element is configured as a compression spring.
优选为,所述容纳腔体内还设置有固定挡块,所述弹性元件的另一端抵接于固定挡块上。Preferably, a fixed block is further provided in the accommodating cavity, and the other end of the elastic element abuts on the fixed block.
本发明一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极可以实现无创、精确、便捷的不可逆电穿孔电极布置,大大减小治疗时操作器械难度,十分适合用于食道癌的治疗,大大降低了患者手术的风险,有助于患者手术治疗。The invasive electrode for irreversible electroporation treatment of esophageal tumor tissue of the present invention can realize non-invasive, accurate and convenient irreversible electroporation electrode arrangement, greatly reduce the difficulty of operating instruments during treatment, and is very suitable for the treatment of esophageal cancer. It reduces the risk of surgery for the patient and facilitates the surgical treatment of the patient.
附图说明Description of drawings
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其它的附图。In order to illustrate the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are For some embodiments of the present invention, for those of ordinary skill in the art, other drawings can also be obtained according to these drawings without creative effort.
图1为本发明一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极结构示意图。FIG. 1 is a schematic structural diagram of an invasive electrode for irreversible electroporation treatment of esophageal tumor tissue according to the present invention.
具体实施方式Detailed ways
为使本发明实施例的目的、技术方案和优点更加清楚,下面将连接本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例是本发明部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the accompanying drawings in the embodiments of the present invention will be connected below, and the technical solutions in the embodiments of the present invention will be described clearly and completely. Obviously, the described embodiments These are some, but not all, embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.
如图1所示,本发明一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极包括:固定外壳10、护套17、电极护套15、电极丝18以及电极11;As shown in FIG. 1 , an invasive electrode for irreversible electroporation treatment of esophageal tumor tissue of the present invention includes: a fixed casing 10 , a
其中,固定外壳10设置为与护套17连接,其上设置有牵拉机构19,牵拉机构19设置为可以相对于固定外壳10位移,Wherein, the fixed casing 10 is arranged to be connected with the
护套17设置为柔性护套,具有中空腔体,其一端连接固定外壳10另一端连接电极护套15;The
电极护套15连接至护套17的一端,其具有容纳腔体15A,容纳腔体15A内可滑动的设置有电极固定环12,电级固定环12的一端连接电极11,因此电极11可以随电极固定环12滑动至容纳腔体15A内部,电级固定环12连接电极11带动其位移可以确保电极11位移平稳(电极11直径太小单独移动可能不平稳),电级固定环12的另一端抵接弹性元件13的一端,弹性元件13设置于容纳腔体15A内其另一端抵接电极护套15,本实施例中容纳腔体15A内还设置有固定挡块14,弹性元件13的另一端抵接于固定挡块14上,因此在初始状态下弹性元件13提供弹力作用至电极固定环12,从而使得电极11可以受力伸出容纳腔体15A外部。The
电极丝18穿过护套17、电极护套15的中空腔体,其一端连接牵拉机构19另一端连接电极11或者电级固定环12,本实施例中连接至电极11上以确保作用力至电极11上,此种连接方式时电级固定环12设置有中空部或者通孔供电极丝18穿过,因此牵拉机构19位移时可以通过拉动电极丝18带动电极11移动从而可以缩进或者伸出容纳腔体15A内。The
本实施例中,牵拉机构19设置为嵌入至固定外壳10中,此种设置便于操作。In this embodiment, the
本实施例中,护套17、电极护套15均设置为金属护套。In this embodiment, the
本实施例中,护套17外层喷涂有派福林涂层16,用于与人体组织绝缘.In this embodiment, the outer layer of the
本实施例中,弹性元件13设置为压缩弹簧。In this embodiment, the
本发明一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极使用时,其绑定在内窥镜上,跟随内窥镜抵达食道肿瘤靶点,在内窥镜进入人体时,操作人员操作牵拉机构19,将电极11收缩至电极护套15的容纳空间15A内部,避免电极损伤人体组织。当内窥镜观察到抵达肿瘤组织靶点位置后,操作人员操作牵拉机构19,通过弹性元件13的作用力将电极11从容纳空间15A内伸出进行治疗,治疗完成后又操作牵拉机构19将电极11收缩回容纳空间15A中,然后取出整个装置。When the invasive electrode of the present invention is used for irreversible electroporation treatment of esophageal tumor tissue, it is bound to the endoscope and follows the endoscope to the esophagus tumor target. When the endoscope enters the human body, the operator operates The
本发明解决了无创进行食道肿瘤组织不可逆电穿孔治疗时,灵活、准确构建所需电场的需求,提出了一种可便携操作的侵入式电极实现方案,可跟随内窥镜抵达目标病患区域,准确调节电极布置位置和插入深度,实现良好的治疗效果。The invention solves the requirement of flexibly and accurately constructing the required electric field during non-invasive treatment of esophageal tumor tissue by irreversible electroporation, and proposes a portable and operable invasive electrode implementation scheme, which can follow the endoscope to reach the target patient area, Accurately adjust the electrode placement position and insertion depth to achieve a good therapeutic effect.
终上所述,本发明一种用于食道肿瘤组织不可逆电穿孔治疗的侵入式电极可以实现无创、精确、便捷的不可逆电穿孔电极布置,大大减小治疗时操作器械难度,十分适合用于食道癌的治疗,大大降低了患者手术的风险,有助于患者手术治疗。As mentioned above, an invasive electrode for irreversible electroporation treatment of esophageal tumor tissue of the present invention can realize non-invasive, accurate and convenient irreversible electroporation electrode arrangement, greatly reduce the difficulty of operating instruments during treatment, and is very suitable for use in esophagus. The treatment of cancer greatly reduces the risk of surgery for patients and helps patients with surgical treatment.
最后应说明的是:以上实施例仅用以说明本发明的技术方案,而非对其限制;尽管参照前述实施例对本发明进行了详细的说明,本领域的普通技术人员应当理解:说明书中的其依然可以对前述各实施例所记载的技术方案进行,或者对其中部分技术特征进行等同替换,而这些修改或者替换,并不使相应技术方案的本质脱离本发明各实施例技术方案的精神和范围。Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, but not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: It can still carry out the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features thereof, and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and spirit of the technical solutions in the embodiments of the present invention. scope.
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