技术领域technical field
本实用新型属于外科器械领域，尤其涉及一种采用射频加热方式向人体传递非机械形式能量的外科器械或装置。The utility model belongs to the field of surgical instruments, in particular to a surgical instrument or device that transmits energy in a non-mechanical form to a human body by means of radio frequency heating.
背景技术Background technique
高血压，尤其是顽固性高血压患者，目前在国内约有两千万人。顽固性高血压主要是指使用足量且合理的三种或以上高血压药物治疗之后，血压仍高于临界水平(140/90mmHg，糖尿病患者130/80mmHg)以上的高血压患者。这类病人需要终身服用多种抗血压药物，花费巨大，且伴随有多种心血管，脑血管的并发症，生活质量极低，因此是高血压防治领域的一大难点。Hypertension, especially resistant hypertension, currently has about 20 million people in China. Refractory hypertension mainly refers to hypertensive patients whose blood pressure is still higher than the critical level (140/90mmHg, 130/80mmHg for diabetic patients) after using sufficient and reasonable treatment of three or more hypertensive drugs. Such patients need to take a variety of antihypertensive drugs for life, which costs a lot, and is accompanied by a variety of cardiovascular and cerebrovascular complications, and the quality of life is extremely low, so it is a major difficulty in the field of hypertension prevention and treatment.
肾脏是人体内一个中枢神经的受体，若过于兴奋，会激活RAAS系统(renin-angiotensin-aldosteronesystem，肾素-血管紧张素-醛固酮系统)，引起高血压。The kidney is a central nervous receptor in the human body. If it is too excited, it will activate the RAAS system (renin-angiotensin-aldosterone system, renin-angiotensin-aldosterone system), causing high blood pressure.
有研究表明，去除肾交感神经后，高血压症状能得到明显改善，其中去甲肾上腺素水平降低75％，血浆中肾素水平也下降了50％以上。Studies have shown that after removing the renal sympathetic nerve, the symptoms of hypertension can be significantly improved, in which the level of norepinephrine is reduced by 75%, and the level of renin in plasma is also reduced by more than 50%.
其次，房颤是一种常见的心率失常，是心肌有不协调的快速微弱蠕动。1997年，有科学家提出房颤主要是由于肺静脉肌袖的快速电激动而触发，而射频消融可以使得肺静脉和心房的解剖连接相互隔离，从而治愈房颤。再者，支气管哮喘也可以经过消融增生的气道平滑肌得到治疗。Secondly, atrial fibrillation is a common arrhythmia, which is an uncoordinated rapid and weak peristalsis of the heart muscle. In 1997, some scientists proposed that atrial fibrillation is mainly triggered by the rapid electrical excitation of the pulmonary vein muscle sleeve, and radiofrequency ablation can isolate the anatomical connection between the pulmonary vein and the atrium, thereby curing atrial fibrillation. Furthermore, bronchial asthma can also be treated by ablation of hyperplastic airway smooth muscle.
导管射频消融电极是一种将导管顺着血管或者体内腔道输送到特定部位，释放射频电流导致神经局部凝固性坏死，达到去神经的介入性技术。射频电流因其损伤范围小，不会造成机体危害，复发几率低，疗效确定，使得导管射频消融技术成为了一种主流的治疗方法用于神经消融。神经坏死后，部分病症如高血压，哮喘，肾衰竭和心脏房颤等等，都可以得到药物治疗所不能达到的效果。Catheter radiofrequency ablation electrode is an interventional technique that transports a catheter along a blood vessel or body cavity to a specific site, releases radiofrequency current to cause local coagulation necrosis of the nerve, and achieves denervation. Due to its small damage range, radiofrequency current will not cause harm to the body, the recurrence rate is low, and the curative effect is certain, making catheter radiofrequency ablation a mainstream treatment method for nerve ablation. After nerve necrosis, some diseases such as high blood pressure, asthma, renal failure and atrial fibrillation, etc., can obtain effects that cannot be achieved by drug treatment.
但是，目前的消融导管，主要是针状或者片状电极，电极消融范围小，就算多个电极叠加也不能覆盖需要消融的区域，形成连续的消融灶，使得消融极为不完善，且消融时电极是盲目放置于消融灶周围，无法对神经精确定位，若没有医生丰富的经验，不完全的消融使得术后达不到治疗效果的可能性大大提高，而治愈率也只能处在50～60％之间，无法得到提高。再者，导管上的电极在电路控制上也是“同开同关”，在能精确定位需要消融的区域时，过多的电极同时通电会对周围健康组织产生不必要的伤害。However, the current ablation catheters are mainly needle-shaped or sheet-shaped electrodes. The ablation range of the electrodes is small. It is blindly placed around the ablation lesion, and it is impossible to accurately locate the nerve. If there is no rich experience of the doctor, incomplete ablation will greatly increase the possibility of not achieving the therapeutic effect after surgery, and the cure rate can only be between 50-60%. %, cannot be raised. Furthermore, the electrodes on the catheter are also "same on and off" in terms of circuit control. When the area to be ablated can be precisely located, too many electrodes energized at the same time will cause unnecessary damage to the surrounding healthy tissue.
实用新型内容Utility model content
本实用新型所要解决的技术问题是提供一种用于体内多点大范围神经热消融的导管射频电极。其在球囊上设置有多个可分别控制的射频消融电极和多个测温热敏电阻，尽可能的覆盖整个球囊内壁，可以扩大消融区的尺寸，减少消融次数，也使得消融更为彻底，其采用精准的薄膜热敏电阻和多个可以单独控制的射频电极，提高了控制的精准度和消融范围，同时球囊的可控扩张使得该装置在腔道内获得了均匀的贴壁压力，提高了治疗效果。The technical problem to be solved by the utility model is to provide a catheter radio frequency electrode for thermal ablation of multiple points and large range of nerves in the body. It is equipped with a plurality of separately controllable radiofrequency ablation electrodes and a plurality of temperature-measuring thermistors on the balloon, covering the entire inner wall of the balloon as much as possible, which can expand the size of the ablation area, reduce the number of ablation times, and make the ablation more efficient. Thoroughly, it uses precise thin film thermistors and multiple radio frequency electrodes that can be individually controlled, which improves the control accuracy and ablation range, and the controllable expansion of the balloon enables the device to obtain a uniform wall-attached pressure in the cavity , improving the therapeutic effect.
本实用新型的技术方案是：提供一种用于体内多点大范围神经热消融的导管射频电极，包括导管，其特征是：The technical scheme of the utility model is: to provide a catheter radio frequency electrode for multi-point large-scale neurothermal ablation in the body, including a catheter, which is characterized in that:
所述的导管为双层导管，在导管的最前端设置有一个球囊；在所述球囊上设置有多个薄膜电极；The catheter is a double-layer catheter, and a balloon is arranged at the front end of the catheter; a plurality of thin-film electrodes are arranged on the balloon;
所述的薄膜电极至少包括绝缘薄膜和设置在绝缘薄膜上的导电层；所述的薄膜电极至少由端部设置区和中部设置区、连接端部设置区和中部设置区的第一连接部、以及从中部设置区引出的引出连接部构成；The thin film electrode at least includes an insulating film and a conductive layer disposed on the insulating film; the thin film electrode is at least composed of an end setting area and a middle setting area, a first connection part connecting the end setting area and the middle setting area, And the lead-out connection part drawn from the central setting area;
所述的端部设置区设置在薄膜电极的端部，所述的中部设置区设置在端部设置区纵轴线的一侧；The end setting area is set at the end of the thin film electrode, and the middle setting area is set on one side of the longitudinal axis of the end setting area;
在每个端部设置区或中部设置区中，在导电层上设置有射频消融电极及热敏电阻；在每个端部设置区或中部设置区中，设置有至少一个射频消融电极组；In each end setting area or middle setting area, a radio frequency ablation electrode and a thermistor are set on the conductive layer; in each end setting area or middle setting area, at least one radio frequency ablation electrode group is set;
所述的射频消融电极组至少包括两个射频消融电极，每个射频消融电极组沿球囊的纵向设置；The radiofrequency ablation electrode group includes at least two radiofrequency ablation electrodes, and each radiofrequency ablation electrode group is arranged along the longitudinal direction of the balloon;
在每个端部设置区或中部设置区中，设置有一个热敏电阻；In each end setting area or middle setting area, a thermistor is arranged;
所述的引出连接部由球囊尾部经由双层导管内引出；The extraction connection part is extracted from the tail of the balloon through the double-layer catheter;
所述每个射频消融电极组经引出连接部的导电层引出后，通过一个电开关与消融电源分别单独连接。After each radio frequency ablation electrode group is led out through the conductive layer of the lead-out connection part, it is separately connected to the ablation power supply through an electric switch.
具体的，所述的多个薄膜电极设置在所述球囊的外表面或内表面。Specifically, the plurality of thin film electrodes are arranged on the outer surface or the inner surface of the balloon.
具体的，在所述热敏电阻的两侧，各设置有一组射频消融电极，每组射频消融电极的导电层经引出连接部引出后，通过一个单独的开关，与消融电源实现“一对一”的电连接关系。Specifically, on both sides of the thermistor, a group of radio frequency ablation electrodes is respectively provided, and after the conductive layer of each group of radio frequency ablation electrodes is drawn out through the lead-out connection part, it realizes "one-to-one" with the ablation power supply through a separate switch. "The electrical connection relationship.
进一步的，在所述的每个射频消融电极组中，设置有至少三个射频消融电极。Further, at least three radiofrequency ablation electrodes are provided in each radiofrequency ablation electrode group.
进一步的，是所述的热敏电阻与射频消融电极组以“串联”的方式构成电连接关系。Further, the thermistor and the radiofrequency ablation electrode group are electrically connected in a "series" manner.
具体的，设置在所述球囊上的多个薄膜电极的端部设置区，沿球囊的纵向轴方向交错排列；所述多个薄膜电极的端部设置区，在所述球囊的表面呈齿状相间分布设置，在球囊的表面构成一个交错互补的加热区域。Specifically, the end setting regions of the plurality of thin film electrodes arranged on the balloon are staggered along the longitudinal axis of the balloon; the end setting regions of the plurality of thin film electrodes are arranged on the surface of the balloon It is arranged in a tooth shape and alternately distributed, forming a staggered and complementary heating area on the surface of the balloon.
或者，设置在所述球囊上的多个薄膜电极的端部设置区及中部设置区，沿球囊的纵向轴方向横向对齐排列；所述多个薄膜电极的端部设置区及中部设置区，在所述球囊的表面构成至少两条环状加热带。Alternatively, the end setting area and the middle setting area of the plurality of thin film electrodes arranged on the balloon are aligned and arranged laterally along the longitudinal axis of the balloon; the end setting areas and the middle setting area of the plurality of thin film electrodes are , forming at least two annular heating bands on the surface of the balloon.
进一步的，在每个端部设置区或中部设置区中，与所述的射频消融电极或射频消融电极组平行地，设置有一个热敏电阻。Further, a thermistor is arranged in parallel with the radio frequency ablation electrode or the radio frequency ablation electrode group in each end setting area or middle setting area.
具体的，所述的射频消融电极和热敏电阻设置在薄膜电极的同一侧面上。Specifically, the radio frequency ablation electrode and the thermistor are arranged on the same side of the thin film electrode.
进一步的，所述的射频消融电极和热敏电阻设置在薄膜电极同一侧面的导电层上；所述薄膜电极的总厚度小于50μm。Further, the radio frequency ablation electrode and the thermistor are arranged on the conductive layer on the same side of the thin film electrode; the total thickness of the thin film electrode is less than 50 μm.
与现有技术比较，本实用新型的优点是：Compared with the prior art, the utility model has the advantages of:
1.本技术方案在球囊上设置多个射频消融电极和测温热敏电阻，尽可能的覆盖整个球囊内壁，可减少消融次数，也使得消融更为彻底，同时球囊的可控扩张性，使得该装置在腔道内可获得均匀的贴壁压力，提高了治疗效果；1. This technical solution sets multiple radio frequency ablation electrodes and temperature measuring thermistors on the balloon to cover the entire inner wall of the balloon as much as possible, which can reduce the number of ablation times and make the ablation more thorough. At the same time, the balloon can be expanded in a controlled manner Sex, so that the device can obtain uniform wall-attaching pressure in the cavity, improving the therapeutic effect;
2.本技术方案的热敏电阻置于射频消融电极的同一侧，因其厚度较小，不会引起割伤组织的可能性，亦可减小测量误差；2. The thermistor of this technical solution is placed on the same side of the radiofrequency ablation electrode, because of its small thickness, it will not cause the possibility of tissue cuts, and can also reduce measurement errors;
3.本技术方案给出了两种不同模式的薄膜电极排列模式，尽可能扩大消融区，提高治疗效果，其中第一种能够覆盖较大范围内的组织；第二种可以造成环形的消融伤害，多次消融叠加后，扩大了消融区。3. This technical solution provides two different modes of thin-film electrode arrangement modes to expand the ablation area as much as possible and improve the treatment effect. The first type can cover a larger range of tissue; the second type can cause ring-shaped ablation damage , after multiple ablation superimpositions, the ablation area is enlarged.
附图说明Description of drawings
图1是本实用新型电极的平面结构示意图；Fig. 1 is the plane structure schematic diagram of the utility model electrode;
图2是本实用新型电极的截面结构示意图；Fig. 2 is the schematic cross-sectional structure diagram of the utility model electrode;
图3是本实用新型第一种薄膜电极排列模式展开示意图；Fig. 3 is a schematic diagram of the expansion of the first thin-film electrode arrangement mode of the present invention;
图4是本实用新型第二种薄膜电极排列模式展开示意图；Fig. 4 is a schematic diagram of the expansion of the second thin film electrode arrangement mode of the present invention;
图5是本实用新型一种实施例的使用状态示意图；Fig. 5 is a schematic diagram of the use state of an embodiment of the utility model;
图6是本实用新型另一种实施例的使用状态示意图。Fig. 6 is a schematic view of another embodiment of the utility model in use.
图中1为双层导管，2为球囊，3为射频消融电极，4为热敏电阻，5为导电层，6为绝缘薄膜。In the figure, 1 is a double-layer catheter, 2 is a balloon, 3 is a radiofrequency ablation electrode, 4 is a thermistor, 5 is a conductive layer, and 6 is an insulating film.
A为端部设置区，B为中部设置区，C为第一连接部，D为引出连接部，DJ为薄膜电极，X为加热区域，X-1、X-2为环状加热带。A is the end setting area, B is the middle setting area, C is the first connection part, D is the lead connection part, DJ is the thin film electrode, X is the heating area, X-1 and X-2 are the annular heating belts.
具体实施方式Detailed ways
下面结合附图和实施例对本实用新型做进一步说明。Below in conjunction with accompanying drawing and embodiment the utility model is described further.
图1至图2中，本实用新型的技术方案提供了一种用于体内多点大范围神经热消融的导管射频电极，包括导管，其发明点在于：In Fig. 1 to Fig. 2, the technical solution of the present invention provides a catheter radio frequency electrode for multi-point large-scale neurothermal ablation in the body, including the catheter, and its invention points are:
所述的导管为双层导管1，在导管上设置有一个球囊2(具体可参见图5、图6中所示)。The catheter is a double-layer catheter 1, and a balloon 2 is arranged on the catheter (see Fig. 5 and Fig. 6 for details).
在球囊上设置有多个薄膜电极DJ；所述的薄膜电极至少包括绝缘薄膜6和设置在绝缘薄膜上的导电层5(参见图2中所示)。A plurality of thin-film electrodes DJ are arranged on the balloon; said thin-film electrodes at least include an insulating thin film 6 and a conductive layer 5 arranged on the insulating thin film (see FIG. 2 ).
所述的电极DJ至少由端部设置区A和中部设置区B、连接端部设置区和中部设置区的第一连接部C、以及从中部设置区引出的引出连接部D构成(参见图1中所示)。The electrode DJ is at least composed of an end setting area A and a middle setting area B, a first connecting portion C connecting the end setting area and the middle setting area, and an extraction connecting portion D drawn from the middle setting area (see FIG. 1 shown in ).
如图1中所示，端部设置区A设置在薄膜电极DJ的端部，中部设置区B设置在端部设置区纵轴线的一侧。As shown in FIG. 1, the end arrangement area A is arranged at the end of the thin film electrode DJ, and the middle arrangement area B is arranged on one side of the longitudinal axis of the end arrangement area.
在每个端部设置区或中部设置区中，在导电层上设置有射频消融电极及热敏电阻。In each end setting area or middle setting area, a radio frequency ablation electrode and a thermistor are arranged on the conductive layer.
在每个端部设置区或中部设置区中，设置有至少一个射频消融电极组；所述的射频消融电极组至少包括两个射频消融电极3，每个射频消融电极组沿球囊的纵向设置。At least one radiofrequency ablation electrode group is arranged in each end part or middle part setting region; the radiofrequency ablation electrode group includes at least two radiofrequency ablation electrodes 3, and each radiofrequency ablation electrode group is arranged along the longitudinal direction of the balloon .
在每个端部设置区或中部设置区中，设置有一个热敏电阻4。In each end arrangement area or middle arrangement area, a thermistor 4 is arranged.
所述的引出连接部由球囊尾部经由双层导管内引出。The leading-out connection part is led out from the tail of the balloon through the double-layer catheter.
如图2中所示，射频消融电极和热敏电阻设置在薄膜电极的同一侧面上。As shown in Fig. 2, the radio frequency ablation electrode and the thermistor are arranged on the same side of the thin film electrode.
进一步的，射频消融电极和热敏电阻设置在薄膜电极同一侧面的导电层上。Further, the radio frequency ablation electrode and the thermistor are arranged on the conductive layer on the same side of the thin film electrode.
将热敏电阻置于射频消融电极的同一侧，因其厚度较小，不会引起割伤组织的可能性，亦可减小测量误差。Placing the thermistor on the same side of the radiofrequency ablation electrode, because of its small thickness, will not cause the possibility of tissue cuts, and can also reduce measurement errors.
如图3、图4中所示，在热敏电阻的两侧，各设置有一组射频消融电极，每组射频消融电极的导电层经引出连接部引出后，通过一个单独的开关(图中未示出)，与消融电源实现“一对一”的电连接关系。As shown in Fig. 3 and Fig. 4, on both sides of the thermistor, a group of radio frequency ablation electrodes is arranged respectively, and after the conductive layer of each group of radio frequency ablation electrodes is drawn out through the lead-out connection part, it passes through a separate switch (not shown in the figure). shown), realize a "one-to-one" electrical connection relationship with the ablation power supply.
进一步的，如图3、图4中所示，在每个射频消融电极组中，设置有三个射频消融电极。Further, as shown in Fig. 3 and Fig. 4, three radio frequency ablation electrodes are arranged in each radio frequency ablation electrode group.
如图3、图4中所示，热敏电阻与射频消融电极组以“串联”的方式构成电连接关系。As shown in Fig. 3 and Fig. 4, the thermistor and the radio frequency ablation electrode group form an electrical connection relationship in a "series" manner.
在图3中，给出了本技术方案中第一种薄膜电极排列模式的展开示意图，图中设置在球囊上的多个薄膜电极的端部设置区，沿球囊的纵向轴方向交错排列；多个薄膜电极的端部设置区，在球囊的表面呈齿状相间分布设置，在球囊的表面构成一个交错互补的加热区域X。In Fig. 3, a schematic diagram of the expansion of the first thin-film electrode arrangement mode in this technical solution is given. In the figure, the end setting areas of the multiple thin-film electrodes arranged on the balloon are staggered along the longitudinal axis of the balloon. The ends of the plurality of thin-film electrodes are disposed on the surface of the balloon in a tooth-like distribution, forming a staggered and complementary heating region X on the surface of the balloon.
在图4中，给出了本技术方案中第二种薄膜电极排列模式的展开示意图，图中，设置在球囊上的多个薄膜电极的端部设置区及中部设置区，沿球囊的纵向轴方向横向对齐排列；多个薄膜电极的端部设置区及中部设置区，在所述球囊的表面构成至少两条环状加热带X-1、X-2。In Fig. 4, a schematic diagram of the expansion of the second thin film electrode arrangement mode in this technical solution is given. In the figure, the end setting area and the middle setting area of a plurality of thin film electrodes arranged on the balloon are arranged along the balloon. The longitudinal axis is aligned and arranged laterally; the end and middle regions of the plurality of thin-film electrodes form at least two annular heating belts X-1 and X-2 on the surface of the balloon.
进一步的，如图3或图4中所示，在每个端部设置区或中部设置区中，热敏电阻与所述的射频消融电极或射频消融电极组平行地设置。Further, as shown in FIG. 3 or FIG. 4 , in each end setting area or middle setting area, the thermistor is arranged parallel to the radio frequency ablation electrode or the radio frequency ablation electrode group.
如图5、图6中所示，所述的导管为双层导管1，在导管上设置有一个球囊2；所述的多个薄膜电极DJ设置在所述球囊的表面或内表面。As shown in Fig. 5 and Fig. 6, the catheter is a double-layer catheter 1, and a balloon 2 is arranged on the catheter; the plurality of thin-film electrodes DJ are arranged on the surface or inner surface of the balloon.
所述每个射频消融电极组经引出连接部的导电层引出后，通过一个电开关(图中未示出)与消融电源(图中未示出)分别单独连接。After each radio frequency ablation electrode group is led out from the conductive layer of the lead-out connection part, it is individually connected to an ablation power supply (not shown) through an electric switch (not shown in the figure).
由于通过电控开关控制一路电路的通断，以及消融电极所采用的电源，均为现有技术，在此不再叙述。Since the on-off of one circuit is controlled by an electronically controlled switch, and the power source used by the ablation electrodes is in the prior art, it will not be described here.
实际制作时，将整个薄膜电极DJ热熔接合于球囊2上，并且于球囊2尾部内使用导线分别焊接薄膜电极上每一个丝网印刷的导线，并且由双层导管1内引出。In actual production, the entire membrane electrode DJ is hot-melt bonded to the balloon 2, and wires are used to weld each screen-printed wire on the membrane electrode at the tail of the balloon 2, and lead out from the double-layer catheter 1.
本技术方案，实际公开了一种能够对肺静脉，肾动脉等腔道内病灶进行多点大范围射频消融的球囊导管。将整个薄膜消融电极(3)热熔接合于球囊(2)上，并且于球囊(2)尾部内使用导线分别焊接薄膜电极上每一个丝网印刷的导线，并且由双层导管(1)内引出。The technical solution actually discloses a balloon catheter capable of performing multi-point and large-scale radiofrequency ablation of lesions in the pulmonary vein, renal artery and other cavities. The entire film ablation electrode (3) is thermally welded on the balloon (2), and wires are used to weld each screen-printed wire on the film electrode in the tail of the balloon (2), and the double-layer catheter (1 ) inside lead.
在本技术方案中，给出了两种不同的薄膜电极排列模式，以尽可能扩大消融区，提高治疗效果；其中第一种薄膜电极的排列模式能够覆盖较大范围内的组织；第二种薄膜电极的排列模式可以造成环形的消融伤害，多次消融叠加后，扩大了消融区。In this technical solution, two different thin-film electrode arrangement patterns are given to expand the ablation area as much as possible and improve the treatment effect; the first thin-film electrode arrangement pattern can cover a larger range of tissues; the second The arrangement mode of the thin-film electrodes can cause circular ablation damage, and the ablation area is expanded after multiple ablation superimpositions.
在本技术方案中，热敏电阻置于射频消融电极的同一侧，因其厚度较小，不会引起割伤组织的可能性。In this technical solution, the thermistor is placed on the same side of the radiofrequency ablation electrode, and because of its small thickness, it will not cause the possibility of cutting tissue.
在本技术方案中，导电层5用于连通消融和测温电路；其上设置有热敏电阻4和射频消融电极3，其总厚度小于50μm。In this technical solution, the conductive layer 5 is used to communicate with the ablation and temperature measurement circuits; the thermistor 4 and the radio frequency ablation electrode 3 are arranged on it, and its total thickness is less than 50 μm.
实际操作时，电极在进行消融前，在球囊内冲入生理盐水或空气，可以控制球囊的扩张程度，以达到贴合体内腔道或血管的程度，并且根据消融电极上的热敏电阻所测得的温度，自动调节输出功率，控制消融区深度为1～4mm，能完成消融包括肾脏交感神经(高血压)，增生的气道平滑肌(支气管哮喘)和肺静脉和心房的解剖连接(房颤)等数种病灶在内的几种现有治疗需求。In actual operation, before the electrode is ablated, physiological saline or air is injected into the balloon to control the expansion of the balloon to achieve the degree of fit to the lumen or blood vessel in the body, and according to the thermistor on the ablation electrode The measured temperature automatically adjusts the output power, and the depth of the ablation zone is controlled to be 1-4mm, which can complete the ablation including renal sympathetic nerve (hypertension), hypertrophic airway smooth muscle (bronchial asthma) and anatomical connection between pulmonary vein and atrium (atrial Tremor) and several other existing treatment needs including several lesions.
本技术方案中，每一个射频消融电极组都可以单独控制启动加热与否，根据医生所掌握的数据和病人情况进行消融。In this technical solution, each radio frequency ablation electrode group can individually control whether to start heating, and perform ablation according to the data mastered by the doctor and the patient's condition.
实际使用时，导管在进行射频消融的时候，可以根据消融不同部位的时候，设定消融温度；如在进行肾交感神经时，设定消融温度65℃，热敏电阻的测量误差为±5％以内，精准的测温线性范围为-50～200℃。In actual use, when the catheter is performing radiofrequency ablation, the ablation temperature can be set according to the time of ablation of different parts; for example, when performing renal sympathetic nerve, set the ablation temperature to 65°C, and the measurement error of the thermistor is ±5% Within, the accurate temperature measurement linear range is -50～200℃.
实际使用时，图5或图6中球囊2的后侧(图中为球囊的右上方)为双层导管，其中一层通过所有导线，另一层为球囊2充气气体或者生理盐水的注入通道。In actual use, the rear side of the balloon 2 in Figure 5 or Figure 6 (the top right of the balloon in the figure) is a double-layer catheter, one of which passes through all the wires, and the other layer is the balloon 2 inflated gas or saline injection channel.
本技术方案中，第一种薄膜电极的排列模式增加了电极的数量和交错的排列方式，减小了电极之间的间隔，增加了消融区的面积，减小无法对消融点定位而产生的误差；第二种薄膜电极的排列模式为环形消融，较为严密接合的电极使得消融更为完善，同时可以多次进行多次消融，减小了消融误差。再者，每一个电极都可以单独控制其加热，因此当消融点可以精准定位的时候，只启动一个或几个电极，即可完成消融，减小不必要的损伤。而更为精准的薄膜热敏电阻，使得消融可以很好的控制；极薄的球囊，直接贴合于人体组织都减小了测温误差。In this technical solution, the arrangement mode of the first thin-film electrode increases the number of electrodes and the staggered arrangement, reduces the interval between electrodes, increases the area of the ablation zone, and reduces the failure to locate the ablation point. Error; the arrangement mode of the second thin-film electrode is circular ablation, and the more tightly bonded electrodes make the ablation more perfect. At the same time, multiple ablation can be performed multiple times, which reduces the ablation error. Furthermore, each electrode can individually control its heating, so when the ablation point can be precisely positioned, only one or a few electrodes can be activated to complete the ablation, reducing unnecessary damage. The more accurate thin-film thermistor makes the ablation well controlled; the extremely thin balloon is directly attached to the human tissue to reduce the temperature measurement error.
本技术方案的最大优势在于对病灶进行极为完整的消融，消融中温度控制的误差极小，同时每一个电极都可以单独控制，提高了消融的精准性，完整性，提高了治疗效果。The biggest advantage of this technical solution is that the lesion is completely ablated, the temperature control error in the ablation is extremely small, and each electrode can be controlled independently, which improves the accuracy and integrity of the ablation, and improves the treatment effect.
整个装置的具体使用过程示意如下：The specific use process of the whole device is shown as follows:
(1)采用第一种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，达到需要消融的区域后，可以向球囊内注入生理盐水或者空气，使得球囊撑起贴壁，若无法确定神经的具体位置且消融电极位于球囊外表面时，设定消融温度(一般为65度)，开启全部消融电极，根据需要消融的深度，30s～60s左右完成一次消融。若有需要，略微转动消融电，30度左右，重复一次消融过程，即可完全覆盖整个消融区。(1) Using the first arrangement pattern of thin-film electrodes, insert the ablation catheter into the body along the body cavity, and after reaching the area to be ablated, inject physiological saline or air into the balloon to make the balloon stick to the wall If the specific location of the nerve cannot be determined and the ablation electrode is located on the outer surface of the balloon, set the ablation temperature (generally 65 degrees), turn on all the ablation electrodes, and complete an ablation in about 30s to 60s according to the depth of ablation required. If necessary, turn the ablation electrode slightly, about 30 degrees, and repeat the ablation process once to completely cover the entire ablation area.
(2)采用第一种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，只能向球囊内注入生理盐水，使得球囊撑起贴壁，达到需要消融的区域后，若无法确定神经的具体位置且消融电极位于球囊内表面时，设定消融温度(一般为70度)，开启全部消融电极，根据需要消融的深度，30s～60s左右完成一次消融。若有需要，略微转动消融电，30度左右，重复一次消融过程，即可完全覆盖整个消融区。(2) Using the first arrangement pattern of thin-film electrodes, after inserting the ablation catheter into the body along the body cavity, only saline can be injected into the balloon so that the balloon sticks up and adheres to the wall, and after reaching the area to be ablated, If the specific location of the nerve cannot be determined and the ablation electrode is located on the inner surface of the balloon, set the ablation temperature (generally 70 degrees), turn on all the ablation electrodes, and complete an ablation in about 30s to 60s according to the required ablation depth. If necessary, turn the ablation electrode slightly, about 30 degrees, and repeat the ablation process once to completely cover the entire ablation area.
(3)采用第二种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，可以向球囊内注入生理盐水或者空气，使得球囊撑起贴壁，达到需要消融的区域后，若能够确定神经的具体位置且消融电极位于球囊外表面时，设定消融温度(一般为65度)，开启单个或几个消融电极，根据需要消融的深度，30s～60s左右完成一次消融后，形成两个环形消融区；若有需要，则转动或者拉动消融电极，重复一次消融过程，即可完全覆盖整个消融区。(3) Using the second arrangement pattern of thin-film electrodes, after inserting the ablation catheter into the body along the body cavity, physiological saline or air can be injected into the balloon to make the balloon stick to the wall and reach the area to be ablated , if the specific location of the nerve can be determined and the ablation electrode is located on the outer surface of the balloon, set the ablation temperature (generally 65 degrees), turn on one or several ablation electrodes, and complete an ablation in about 30s to 60s according to the depth of ablation required Finally, two ring-shaped ablation zones are formed; if necessary, the ablation electrode is rotated or pulled, and the ablation process is repeated to completely cover the entire ablation zone.
(4)采用二种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，只能向球囊内注入生理盐水，使得球囊撑起贴壁，达到需要消融的区域后，若能够确定神经的具体位置且消融电极位于球囊内表面时，设定消融温度(一般为70度)，开启单个或几个消融电极，根据需要消融的深度，30s～60s左右完成一次消融后，形成两个环形消融区；若有需要，则转动或者拉动消融电极，重复一次消融过程，即可完全覆盖整个消融区。(4) Two kinds of thin-film electrode arrangements are adopted. After the ablation catheter is inserted into the body along the body cavity, physiological saline can only be injected into the balloon so that the balloon can stick to the wall and reach the area to be ablated. When the specific location of the nerve can be determined and the ablation electrode is located on the inner surface of the balloon, set the ablation temperature (generally 70 degrees), turn on one or several ablation electrodes, and complete an ablation in about 30s to 60s according to the depth of ablation required. Two ring-shaped ablation zones are formed; if necessary, turn or pull the ablation electrode and repeat the ablation process to completely cover the entire ablation zone.
(5)采用第二种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，可以向球囊内注入生理盐水或者空气，使得球囊撑起贴壁，达到需要消融的区域后，若无法确定神经的具体位置且消融电极位于球囊外表面时，设定消融温度(一般为65度)，开启全部消融电极，根据需要消融的深度，30s～60s左右完成一次消融后，形成两个环形消融区；接着拉动消融导管，使得拉动长度等于消融电极的尺寸，重复一次消融过程，即可完全覆盖整个消融区。(5) Using the second arrangement pattern of thin-film electrodes, after inserting the ablation catheter into the body along the body cavity, physiological saline or air can be injected into the balloon to make the balloon stick to the wall and reach the area to be ablated If the specific location of the nerve cannot be determined and the ablation electrode is located on the outer surface of the balloon, set the ablation temperature (generally 65 degrees), turn on all the ablation electrodes, and complete an ablation in about 30s to 60s according to the depth of ablation required. Two annular ablation zones; then pull the ablation catheter so that the pulling length is equal to the size of the ablation electrode, and repeat the ablation process once to completely cover the entire ablation zone.
(6)采用第二种薄膜电极的排列模式，将消融导管顺着体内腔道插入体内后，只能向球囊内注入生理盐水，使得球囊撑起贴壁，达到需要消融的区域后，若无法确定神经的具体位置且消融电极位于球囊内表面时，设定消融温度(一般为70度)，开启全部消融电极，根据需要消融的深度，30s～60s左右完成一次消融后，形成两个环形消融区；接着拉动消融导管，使得拉动长度等于消融电极的尺寸，重复一次消融过程，即可完全覆盖整个消融区。(6) Adopting the second arrangement pattern of thin-film electrodes, after inserting the ablation catheter into the body along the body cavity, only saline can be injected into the balloon so that the balloon can prop up and adhere to the wall, and after reaching the area to be ablated, If the specific location of the nerve cannot be determined and the ablation electrode is located on the inner surface of the balloon, set the ablation temperature (generally 70 degrees), turn on all the ablation electrodes, and complete one ablation in about 30s to 60s according to the required ablation depth, then form two An annular ablation zone; then pull the ablation catheter so that the pulling length is equal to the size of the ablation electrode, and repeat the ablation process once to completely cover the entire ablation zone.
由于本实用新型在球囊上设置多个射频消融电极和测温热敏电阻，尽可能的覆盖整个球囊内壁，可以扩大消融区的尺寸，对需要治疗的区域进行很完整的消融，提高治疗效果。精准的薄膜热敏电阻，多个可以单独控制的射频电极，同时极薄的电极贴合于球囊外部，与组织直接接触，提高了控制的精准度和消融范围。Since the utility model is equipped with a plurality of radio frequency ablation electrodes and temperature measuring thermistors on the balloon, the entire inner wall of the balloon can be covered as much as possible, the size of the ablation area can be enlarged, and the area to be treated can be completely ablated, improving the treatment efficiency. Effect. Precise thin-film thermistors, multiple radio frequency electrodes that can be individually controlled, and the extremely thin electrodes are attached to the outside of the balloon and are in direct contact with the tissue, improving the control accuracy and ablation range.
本实用新型可广泛用于多点大范围射频消融球囊导管的设计和制造领域。The utility model can be widely used in the field of design and manufacture of multi-point and large-range radio frequency ablation balloon catheters.
| Application Number | Priority Date | Filing Date | Title |
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| CN201720379557.XUCN207384322U (en) | 2017-04-12 | 2017-04-12 | A kind of conduit radio-frequency electrode for the neural heating ablation on a large scale of internal multiple spot |
| Application Number | Priority Date | Filing Date | Title |
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| CN201720379557.XUCN207384322U (en) | 2017-04-12 | 2017-04-12 | A kind of conduit radio-frequency electrode for the neural heating ablation on a large scale of internal multiple spot |
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| CN207384322Utrue CN207384322U (en) | 2018-05-22 |
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| CN201720379557.XUActiveCN207384322U (en) | 2017-04-12 | 2017-04-12 | A kind of conduit radio-frequency electrode for the neural heating ablation on a large scale of internal multiple spot |
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| CN113143445A (en)* | 2021-03-11 | 2021-07-23 | 上海交通大学 | Radiofrequency ablation probe system capable of conformal thermal ablation |
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