CN115813529A - Pulse ablation device with saline water perfusion function - Google Patents
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Translated fromChinese技术领域technical field
本公开涉及血管手术技术领域，特别涉及一种具有盐水灌注功能的脉冲消融装置。The present disclosure relates to the technical field of vascular surgery, in particular to a pulse ablation device with a saline perfusion function.
背景技术Background technique
房颤是指心房颤动，是最常见的持续性心律失常。随着年龄增长房颤的发生率不断增加，75岁以上人群可达10％。房颤时心房激动的频率达300～600次/分，心跳频率往往快而且不规则，有时候可达100～160次/分，不仅比正常人心跳快得多，而且绝对不整齐，心房失去有效的收缩功能。房颤患病率还与冠心病、高血压病和心力衰竭等疾病有密切关系。房颤分类没有统一，按持续时间可以分为阵发性房颤、持续性房颤和永久性房颤。通常认为阵发性房颤指能在7天内自行转复为窦性心律者，一般持续时间小于48小时；持续性房颤指持续7天以上，需要药物或电击才能转复为窦性心律者；永久性房颤指不能转复为窦性心律或在转复后24小时内复发者。Atrial fibrillation refers to atrial fibrillation, the most common sustained cardiac arrhythmia. The incidence of atrial fibrillation continues to increase with age, up to 10% of people over the age of 75. During atrial fibrillation, the frequency of atrial excitement reaches 300-600 beats/min, and the heartbeat frequency is often fast and irregular, sometimes up to 100-160 beats/min. Effective retraction function. The prevalence of atrial fibrillation is also closely related to diseases such as coronary heart disease, hypertension and heart failure. Atrial fibrillation is not uniformly classified, and can be divided into paroxysmal atrial fibrillation, persistent atrial fibrillation, and permanent atrial fibrillation according to the duration. It is generally believed that paroxysmal atrial fibrillation refers to those who can switch to sinus rhythm spontaneously within 7 days, and generally lasts for less than 48 hours; persistent atrial fibrillation refers to those who last for more than 7 days and need drugs or electric shocks to switch to sinus rhythm ; Permanent atrial fibrillation refers to those who cannot be converted to sinus rhythm or relapse within 24 hours after conversion.
临床上目前常用于治疗心房颤动等心律失常的方式包括药物治疗、心外科消融手术、心内导管消融手术等。其中，心内导管消融术具有创伤小、后续风险低(无植入物)等优点，成为房颤治疗的常见方式。然而，目前心内导管消融房颤中存在术后复发率高的问题，尽管有三维定位标测系统、压力感应导管等高技术心内消融设备与导管的支撑，但对于目前房颤中的病症相对轻微的阵发性房颤(房颤持续时间小于7天)的治愈率为70％；而症状较重的持续性房颤患者(房颤持续时间大于7天)的消融成功率更低，术后复发的可能性更高。与此形成鲜明对比的是，心外科体外循环下迷宫手术消融房颤的成功率能够到达90％以上。但鉴于需要开胸、建立体外循环手术创伤等原因，并未广泛开展用于单纯性房颤。尽管如此，随着微创外科胸腔镜技术在心外科的快速发展，胸腔镜心脏不停跳下心外膜外科消融技术治疗房颤，由于避免开胸，不需要建立体外循环，明显降低了手术创伤，在国际范围内得到越来越多的开展。指南推荐对于导管消融后复发的阵发性或持续性房颤，存在导管消融复发因素的阵发性或持续性房颤，可进行胸腔镜下心外膜消融。目前，微创的外科消融成为突破导管消融治疗房颤疗效瓶颈的重要技术。The methods currently commonly used clinically to treat arrhythmias such as atrial fibrillation include drug therapy, cardiac surgical ablation, and intracardiac catheter ablation. Among them, intracardiac catheter ablation has the advantages of less trauma and low follow-up risk (no implants), and has become a common method for the treatment of atrial fibrillation. However, the current intracardiac catheter ablation of atrial fibrillation has the problem of high postoperative recurrence rate. Despite the support of high-tech intracardiac ablation equipment and catheters such as three-dimensional positioning and mapping systems and pressure-sensing catheters, the current symptoms of atrial fibrillation Relatively mild paroxysmal atrial fibrillation (atrial fibrillation lasting less than 7 days) has a cure rate of 70%; while patients with severe symptoms of persistent atrial fibrillation (atrial fibrillation lasting more than 7 days) have a lower ablation success rate, There is a higher chance of recurrence after surgery. In stark contrast to this, the success rate of ablation of atrial fibrillation by maze surgery under cardiopulmonary bypass can reach more than 90%. However, due to reasons such as the need for thoracotomy and the establishment of extracorporeal circulation surgical trauma, it has not been widely used for simple atrial fibrillation. Nevertheless, with the rapid development of minimally invasive surgical thoracoscopy in cardiac surgery, thoracoscopic heart beating and epicardial surgical ablation for atrial fibrillation can significantly reduce surgical trauma because of the avoidance of thoracotomy and the need for extracorporeal circulation. It has been increasingly carried out internationally. The guidelines recommend thoracoscopic epicardial ablation for paroxysmal or persistent atrial fibrillation that recurs after catheter ablation, and for paroxysmal or persistent atrial fibrillation with catheter ablation recurrence factors. At present, minimally invasive surgical ablation has become an important technology to break through the bottleneck of catheter ablation in the treatment of atrial fibrillation.
在传统的心外科治疗房颤的手术中，射频消融和冷冻消融是常用方式，其中，射频消融是释放射频电流使目标靶点部位的组织细胞产生凝固性坏死。冷冻消融是继射频消融之后的心律失常治疗新技术，其原理是通过液态制冷剂的吸热蒸发，带走组织热量，使目标消融部位温度降低，异常电生理的细胞组织遭到破坏，从而减除心律失常的风险。无论是射频消融和冷冻消融，均为热能消融，在心脏停跳下，可获得良好的消融组织透壁性，但在心脏跳动状态下，由于心腔内流动血液的热沉效应，降低了组织透壁性损伤效能，这被认为是影响胸腔镜心脏不停跳下心外膜消融治疗房颤疗效的关键因素。临床上亟需一种新的能量可以克服心腔血液的热沉效应对组织损伤的影响。In traditional cardiac surgery for the treatment of atrial fibrillation, radiofrequency ablation and cryoablation are commonly used methods. Among them, radiofrequency ablation is to release radiofrequency current to cause coagulation necrosis of tissue cells at the target site. Cryoablation is a new technology for the treatment of arrhythmia after radiofrequency ablation. Its principle is that through the heat absorption and evaporation of liquid refrigerant, the heat of the tissue is taken away, the temperature of the target ablation site is lowered, and the cells and tissues with abnormal electrophysiology are destroyed, thereby reducing the In addition to the risk of arrhythmia. Both radiofrequency ablation and cryoablation are heat energy ablation. Under cardiac arrest, good transmural ablation tissue can be obtained. The efficacy of transmural injury, which is considered to be a key factor affecting the efficacy of thoracoscopic epicardial ablation with beating heart in the treatment of atrial fibrillation. Clinically, there is an urgent need for a new energy that can overcome the heat sink effect of blood in the heart cavity on tissue damage.
脉冲消融是通过设计适当的脉冲电场，采用短时程，高电压的多个电脉冲来进行消融能量的释放，使得消融过程为非热能消融(无焦耳产热)，有效的诱导心肌细胞发生电穿孔，使细胞外阳离子进入细胞，心肌细胞碎裂死亡(脉冲电场消融因此也被称作不可逆电穿孔)。在胸腔镜下房颤消融手术中采用脉冲消融方式时，由于患者处于全麻状态，放电电极可以采用较高电压用以实现心外膜向内的透壁性损伤，由于是直视状态下的消融，可以避免目标靶点区域外组织的副损伤。Pulse ablation is to release ablation energy by designing an appropriate pulse electric field and using short-term, high-voltage multiple electric pulses, so that the ablation process is non-thermal ablation (no Joule heat generation), and effectively induces cardiomyocytes to generate electricity. Perforation, allowing extracellular cations to enter the cell, fragments the cardiomyocyte and dies (ablation with pulsed electric fields is therefore also called irreversible electroporation). When pulse ablation is used in thoracoscopic atrial fibrillation ablation, since the patient is under general anesthesia, the discharge electrode can use a higher voltage to achieve transmural damage of the epicardium inward. Ablation can avoid secondary damage to tissues outside the target area.
现有技术中在采用脉冲消融过程中，在非液体环境可能存在电极间产生电火花的风险，并且为了消融器械与目标靶点区域进行良好的接触，需要在两者间形成湿化环境。In the prior art, during the pulse ablation process, there may be a risk of electric sparks between the electrodes in a non-liquid environment, and in order to make good contact between the ablation device and the target area, a humidified environment needs to be formed between the two.
发明内容Contents of the invention
本公开实施例的目的在于提供一种具有盐水灌注功能的脉冲消融装置，以解决现有技术中脉冲消融在心外科房颤消融治疗中的问题。The purpose of the embodiments of the present disclosure is to provide a pulse ablation device with saline infusion function, so as to solve the problems of pulse ablation in the ablation treatment of atrial fibrillation in cardiac surgery in the prior art.
本公开实施例提供一种具有盐水灌注功能的脉冲消融装置，其包括依次连接的头端组件、手柄组件以及后端组件，所述头端组件与所述手柄组件之间通过连接组件连接，在所述头端组件上设置电极和灌注孔，所述灌注孔设置在所述电极上和/或设置在所述电极的附近。An embodiment of the present disclosure provides a pulse ablation device with a saline infusion function, which includes a head-end assembly, a handle assembly, and a rear-end assembly connected in sequence, and the head-end assembly and the handle assembly are connected through a connection assembly. An electrode and a perfusion hole are provided on the head end assembly, and the perfusion hole is provided on the electrode and/or near the electrode.
在一些实施例中，所述头端组件能够相对所述连接组件旋转以具有调弯功能。In some embodiments, the head end assembly is rotatable relative to the connecting assembly to have a bending function.
在一些实施例中，所述手柄组件包括手柄外壳，在所述手柄外壳上设置滑动按键，通过所述滑动按键的滑动以实现所述头端组件的旋转调弯。In some embodiments, the handle assembly includes a handle housing, on which a sliding button is arranged, and the rotation and bending adjustment of the head end assembly is realized by sliding the sliding button.
在一些实施例中，所述头端组件包括头端外壳，多个所述电极设置在所述头端外壳的侧面和/或端面上，In some embodiments, the head-end assembly includes a head-end housing, and a plurality of the electrodes are arranged on the side and/or end surface of the head-end housing,
在一些实施例中，所述头端外壳上设置至少一个电极对，所述灌注孔设置在所述电极对的电极上或者所述电极对之间或者设置在所述电极对的外侧或者环绕所述电极对中电极的四周设置。In some embodiments, at least one electrode pair is provided on the head-end shell, and the perfusion hole is provided on the electrodes of the electrode pair or between the electrode pairs or outside the electrode pair or around all electrodes. The electrodes are arranged around the electrodes in the pair of electrodes.
在一些实施例中，所述头端外壳的端部通过头端夹片与所述连接组件连接，在所述头端外壳上设置两个拉索，每个所述拉索的一端设置在所述头端外壳端部的连接部上，其另一端穿过所述头端夹片并穿入至所述连接组件中。In some embodiments, the end of the head-end housing is connected to the connection assembly through a head-end clip, two pull cables are arranged on the head-end casing, and one end of each of the pull cables is arranged on the The other end passes through the clip of the head end and penetrates into the connecting assembly.
在一些实施例中，所述头端夹片为两个，两个所述头端夹片相互卡合以扣接在所述拉索的外侧，两个所述拉索相对所述头端夹片以及在所述连接组件内为上下对称分布。In some embodiments, there are two head-end clips, and the two head-end clips are engaged with each other so as to be buckled on the outside of the cable, and the two clips are opposite to the head-end clip. The slices are symmetrically distributed up and down in the connection assembly.
在一些实施例中，在所述连接部上设置凸轴，所述凸轴与所述头端组件的长度方向相互垂直设置，每一侧对应的所述头端夹片的第一端部设置圆形的通孔，所述凸轴穿过所述通孔使得所述头端外壳与所述头端夹片两者配合安装。In some embodiments, a protruding shaft is arranged on the connecting part, the protruding shaft is arranged perpendicular to the length direction of the head end assembly, and the first end of the head end clip corresponding to each side is arranged A circular through hole, the protruding shaft passes through the through hole so that the head-end shell and the head-end clip are installed in cooperation.
在一些实施例中，在所述头端夹片的第二端部的内侧设置连接柱，所述连接柱能够插入到所述连接组件上的连接孔上以实现所述头端夹片与所述连接组件之间的固定。In some embodiments, a connecting post is provided on the inner side of the second end of the head-end clip, and the connecting post can be inserted into the connection hole on the connecting component to realize the connection between the head-end clip and the Fixation between the above-mentioned connected components.
在一些实施例中，在所述手柄外壳中设置压片，所述连接组件的尾部在所述手柄外壳中通过所述压片压紧固定。In some embodiments, a pressing piece is provided in the handle housing, and the tail of the connecting component is pressed and fixed in the handle housing by the pressing piece.
在一些实施例中，在所述手柄外壳中设置压片柱，在所述压片柱上设置安装孔，通过第一紧固件和所述安装孔相互配合以将所述连接组件的尾部固定在所述压片柱上。In some embodiments, a pressing post is provided in the handle housing, and a mounting hole is provided on the pressing post, and the tail of the connection assembly is fixed by cooperating with the first fastener and the mounting hole. on the tableting column.
在一些实施例中，在所述手柄外壳内还设置滑块和滚轴，所述滑块与所述滑动按键连接，在所述滑块内部设有连通孔，所述连接组件伸入到所述手柄外壳中并穿过所述滑块上的所述连通孔，使得所述滑块安装在所述连接组件上并在所述连接组件上自由移动，所述滚轴设置在所述滑块的远离所述连接组件的一侧。In some embodiments, a slider and a roller are also provided in the handle housing, the slider is connected to the sliding button, a communication hole is provided inside the slider, and the connecting component extends into the in the handle housing and pass through the communication hole on the slider, so that the slider is installed on the connection assembly and can move freely on the connection assembly, and the roller is arranged on the slider the side away from the connection assembly.
在一些实施例中，在所述滑块的两侧设置第一凸起结构，所述第一凸起结构与所述拉索连接以用于固定所述拉索，其中，一侧引出的所述拉索直接穿入所述滑块一侧设置的所述第一凸起结构，通过第二紧固件将其固定于所述滑块的一侧；另一侧引出的所述拉索延伸绕过固定于所述滚轴，调整方向后穿入所述滑块另一侧设置的所述第一凸起结构，通过第二紧固件将其固定于所述滑块的另一侧。In some embodiments, a first protruding structure is provided on both sides of the slider, and the first protruding structure is connected with the cable for fixing the cable, wherein the The pulling cable directly penetrates the first protruding structure provided on one side of the slider, and is fixed to one side of the sliding block by a second fastener; the pulling cable drawn out from the other side extends Bypassing the roller shaft, adjusting the direction and passing through the first protruding structure provided on the other side of the slider, and fixing it to the other side of the slider through a second fastener.
在一些实施例中，所述连接组件中的内部灌注管的另一端与鲁尔接头连接，所述鲁尔接头与外部的灌注泵连接。In some embodiments, the other end of the internal perfusion tube in the connection assembly is connected to a Luer connector, and the Luer connector is connected to an external perfusion pump.
在一些实施例中，所述后端组件包括外部灌注管，所述外部灌注管的一端与所述连接组件中的内部灌注管连接，其另一端与鲁尔接头连接，所述鲁尔接头与外部的灌注泵连接。In some embodiments, the rear end assembly includes an external perfusion tube, one end of the external perfusion tube is connected to the internal perfusion tube in the connection assembly, and the other end is connected to a Luer connector, and the Luer connector is connected to the External perfusion pump connection.
在一些实施例中，所述后端组件还包括电气接头，所述电气接头通过第三紧固件固定于手柄组件的尾部，所述电气接头的一端与所述电极的导线连接，另一端在所述手柄组件的外部与转接线缆连接，通过转接线缆与外部的脉冲消融仪连接。In some embodiments, the rear end assembly further includes an electrical connector, the electrical connector is fixed to the tail of the handle assembly through a third fastener, one end of the electrical connector is connected to the wire of the electrode, and the other end is connected to the The outside of the handle assembly is connected to the transfer cable, and is connected to the external pulse ablation instrument through the transfer cable.
在一些实施例中，在所述头端组件中设置分配管，所述分配管与所述连接组件中的内部盐水灌注管连接，所述分配管中包括至少一个输送腔，所述输送腔与所述灌注孔连通。In some embodiments, a distribution tube is provided in the head end assembly, the distribution tube is connected to the internal saline infusion tube in the connection assembly, the distribution tube includes at least one delivery cavity, and the delivery cavity is connected to The perfusion holes are connected.
在一些实施例中，所述分配管内设置多个输送腔，多个所述输送腔与所述灌注孔对应设置。In some embodiments, a plurality of delivery chambers are arranged in the distribution pipe, and the plurality of delivery chambers are arranged corresponding to the perfusion holes.
在一些实施例中，所述输送腔通过毛细管与所述灌注孔对应连接，所述毛细管以平行于所述分配管的方式设置。In some embodiments, the delivery chamber is correspondingly connected to the perfusion hole through a capillary, and the capillary is arranged parallel to the distribution pipe.
在一些实施例中，在所述分配管的侧面设置多个排出孔，所述排出孔与所述灌注孔对应设置In some embodiments, a plurality of discharge holes are arranged on the side of the distribution pipe, and the discharge holes are arranged corresponding to the filling holes
在一些实施例中，所述排出孔通过毛细管与所述灌注孔连接，所述毛细管以垂直于所述分配管的方式布置。In some embodiments, the discharge hole is connected to the perfusion hole by a capillary arranged perpendicularly to the distribution tube.
本公开实施例的所述脉冲消融装置在执行脉冲消融的过程中通过盐水灌注可以在消融组织表面提供相对湿润的环境，防止因心外膜脂肪阻断电场而影响消融效果，同时能够有效避免在空气环境中电极间高电压导致的电火花的产生，提高心外脉冲消融手术的安全性和有效性。The pulse ablation device according to the embodiment of the present disclosure can provide a relatively moist environment on the surface of the ablated tissue through saline perfusion during the pulse ablation process, preventing the ablation effect from being affected by the epicardial fat blocking the electric field, and effectively avoiding the The generation of electric sparks caused by high voltage between electrodes in the air environment improves the safety and effectiveness of extracardiac pulse ablation.
本公开实施例用于房颤治疗，通过脉冲能量的使用，弥补了射频、冷冻消融在心外科房颤消融领域由于能量特性所带来的不足之处，降低消融过程中电极表面温度，从而保证手术过程中不会出现温度过高而导致射频消融中断，提高脉冲消融器具的实用性以及消融手术的安全性和有效性。The embodiment of the present disclosure is used for the treatment of atrial fibrillation. Through the use of pulse energy, it makes up for the deficiencies caused by the energy characteristics of radiofrequency and cryoablation in the field of atrial fibrillation ablation in cardiac surgery, and reduces the temperature of the electrode surface during the ablation process, thereby ensuring the operation During the process, there will be no interruption of radiofrequency ablation caused by excessive temperature, which improves the practicability of the pulse ablation instrument and the safety and effectiveness of the ablation operation.
附图说明Description of drawings
为了更清楚地说明本公开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，下面描述中的附图仅仅是本公开中记载的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动性的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments described in the present disclosure. Those skilled in the art can also obtain other drawings based on these drawings without any creative effort.
图1为本公开实施例的脉冲消融装置的结构示意图；FIG. 1 is a schematic structural diagram of a pulse ablation device according to an embodiment of the present disclosure;
图2为本公开实施例的脉冲消融装置中头端组件的结构示意图；FIG. 2 is a schematic structural diagram of a head-end assembly in a pulse ablation device according to an embodiment of the present disclosure;
图3为本公开实施例的脉冲消融装置中连接组件的结构示意图；Fig. 3 is a schematic structural diagram of a connection component in a pulse ablation device according to an embodiment of the present disclosure;
图4为本公开实施例的脉冲消融装置中头端组件的结构示意图；FIG. 4 is a schematic structural diagram of a head-end assembly in a pulse ablation device according to an embodiment of the present disclosure;
图5为本公开实施例的脉冲消融装置中头端组件的结构示意图；FIG. 5 is a schematic structural diagram of a head-end assembly in a pulse ablation device according to an embodiment of the present disclosure;
图6为本公开实施例的脉冲消融装置中头端组件的另一种结构示意图；Fig. 6 is another schematic structural view of the head-end assembly in the pulse ablation device according to the embodiment of the present disclosure;
图7为本公开实施例的脉冲消融装置中手柄组件的结构示意图；Fig. 7 is a schematic structural view of the handle assembly in the pulse ablation device according to the embodiment of the present disclosure;
图8为本公开实施例的脉冲消融装置中手柄组件的结构示意图；Fig. 8 is a schematic structural view of the handle assembly in the pulse ablation device according to the embodiment of the present disclosure;
图9为本公开实施例的脉冲消融装置中电极和灌注孔的布置示意图；9 is a schematic diagram of the arrangement of electrodes and perfusion holes in the pulse ablation device according to an embodiment of the present disclosure;
图10为本公开实施例的脉冲消融装置中盐水灌注通路的示意图；10 is a schematic diagram of a saline perfusion channel in a pulse ablation device according to an embodiment of the present disclosure;
图11为本公开实施例的脉冲消融装置中盐水灌注通路的示意图。Fig. 11 is a schematic diagram of a saline perfusion channel in a pulse ablation device according to an embodiment of the present disclosure.
附图标记：Reference signs:
1-头端组件；11-电极；12-头端外壳；121-第一外壳；122-第二外壳；13-拉索；14-头端夹片；141-通孔；142-连接柱；15-灌注孔；16-分配管；17-毛细管；18-连接部；19-凸轴；161-输送腔；162-排出孔；2-连接组件；21-内部灌注管；3-手柄组件；31-滑动按键；32-手柄外壳；33-压片；331-压片柱；34-滑块；341-第一凸起结构；342-第二凸起结构；343-硅胶帽；344-凹槽；35-滚轴；36-第二紧固件；37-第一紧固件；38-第三紧固件；39-限位凸起；4-后端组件；41-外部灌注管；42-鲁尔接头；43-电气接头。1-head assembly; 11-electrode; 12-head shell; 121-first shell; 122-second shell; 13-pull cable; 14-head clip; 141-through hole; 15-infusion hole; 16-distribution pipe; 17-capillary; 18-connection; 19-protruding shaft; 161-transport cavity; 162-discharge hole; 2-connection assembly; 31-sliding button; 32-handle shell; 33-pressing tablet; 331-pressing column; 34-slider; 341-first raised structure; 342-second raised structure; Groove; 35-roller; 36-second fastener; 37-first fastener; 38-third fastener; 39-limit protrusion; 4-rear end assembly; 41-external perfusion tube; 42-Luer connector; 43-electrical connector.
具体实施方式Detailed ways
此处参考附图描述本公开的各种方案以及特征。Various aspects and features of the present disclosure are described herein with reference to the accompanying drawings.
应理解的是，可以对此处申请的实施例做出各种修改。因此，上述说明书不应该视为限制，而仅是作为实施例的范例。本领域的技术人员将想到在本公开的范围和精神内的其他修改。It should be understood that various modifications may be made to the embodiments applied for herein. Accordingly, the above description should not be viewed as limiting, but only as exemplifications of embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the disclosure.
包含在说明书中并构成说明书的一部分的附图示出了本公开的实施例，并且与上面给出的对本公开的大致描述以及下面给出的对实施例的详细描述一起用于解释本公开的原理。The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and, together with the general description of the disclosure given above and the detailed description of the embodiments given below, serve to explain the embodiments of the disclosure. principle.
通过下面参照附图对给定为非限制性实例的实施例的优选形式的描述，本公开的这些和其它特性将会变得显而易见。These and other characteristics of the present disclosure will become apparent from the following description of preferred forms of embodiment given as non-limiting examples with reference to the accompanying drawings.
还应当理解，尽管已经参照一些具体实例对本公开进行了描述，但本领域技术人员能够确定地实现本公开的很多其它等效形式，它们具有如权利要求所述的特征并因此都位于借此所限定的保护范围内。It should also be understood that, while the disclosure has been described with reference to a few specific examples, those skilled in the art will surely be able to implement many other equivalents of the disclosure which have the features of the claims and which are therefore situated within the scope of the claims. within the limited scope of protection.
当结合附图时，鉴于以下详细说明，本公开的上述和其他方面、特征和优势将变得更为显而易见。The above and other aspects, features and advantages of the present disclosure will become more apparent in view of the following detailed description when taken in conjunction with the accompanying drawings.
此后参照附图描述本公开的具体实施例；然而，应当理解，所申请的实施例仅仅是本公开的实例，其可采用多种方式实施。熟知和/或重复的功能和结构并未详细描述以避免不必要或多余的细节使得本公开模糊不清。因此，本文所申请的具体的结构性和功能性细节并非意在限定，而是仅仅作为权利要求的基础和代表性基础用于教导本领域技术人员以实质上任意合适的详细结构多样地使用本公开。Specific embodiments of the present disclosure are hereinafter described with reference to the accompanying drawings; however, it should be understood that the applied embodiments are merely examples of the disclosure, which may be embodied in various ways. Well-known and/or repetitive functions and constructions are not described in detail to avoid obscuring the disclosure with unnecessary or redundant detail. Therefore, specific structural and functional details disclosed herein are not intended to be limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any suitable detailed structure. public.
本说明书可使用词组“在一种实施例中”、“在另一个实施例中”、“在又一实施例中”或“在其他实施例中”，其均可指代根据本公开的相同或不同实施例中的一个或多个。This specification may use the phrases "in one embodiment," "in another embodiment," "in yet another embodiment," or "in other embodiments," which may refer to the same or one or more of the different embodiments.
本公开的实施例提供一种具有盐水灌注功能的脉冲消融装置，为了便于在患者体内执行脉冲消融操作以及考虑到所述脉冲消融装置的携带和使用，所述脉冲消融装置可以采用任意合适的形状，例如可以采用笔状，这样所述脉冲消融装置可以形成脉冲消融笔，这样具有较高的便携性。Embodiments of the present disclosure provide a pulse ablation device with a saline infusion function. In order to facilitate the pulse ablation operation in the patient's body and consider the carrying and use of the pulse ablation device, the pulse ablation device can adopt any suitable shape , for example, can be in the shape of a pen, so that the pulse ablation device can form a pulse ablation pen, which has high portability.
所述脉冲消融装置的结构如图1所示，本公开实施例涉及的所述脉冲消融装置包括依次连接的头端组件1、手柄组件3以及后端组件4，所述头端组件1与所述手柄组件3之间通过连接组件2连接，其中，所述头端组件1能够相对所述连接组件2能够旋转以具有调弯功能，从而调节所述脉冲消融装置的头端的形状和姿态以满足不同的需求，这里例如可以通过所述手柄组件3控制所述头端组件1的调弯程度。The structure of the pulse ablation device is shown in Figure 1. The pulse ablation device involved in the embodiment of the present disclosure includes a head-
进一步地，在所述头端组件1上设置电极和灌注孔，这里的所述电极用于通电后在患者体内的指定位置执行脉冲消融操作，这里的所述灌注孔用于在执行脉冲消融操作的过程中实现盐水灌注，其中，所述灌注孔可以根据所述电极的尺寸和布置方式进行相应设置，这里的所述灌注孔例如可以设置在所述电极上，也可以设置在所述电极的附近。本公开实施例提供的所述脉冲消融装置能够提供标测、调弯、盐水灌注以及脉冲消融等多种功能。Further, electrodes and perfusion holes are provided on the head-
进一步地，如上所述，这里的所述连接组件2用于连接所述头端组件1和所述手柄组件3，其长度用于连接可以根据实际需要调整，从而根据不同的脉冲消融位置延长或者缩短所述脉冲消融装置的整体长度，所述连接组件2的材质可以选择不锈钢、合金或其他材料。在一个实施方式中，所述连接组件2采用中空的管状结构，所述连接组件2例如可以是连接杆的形式，如图3所示，在所述连接组件2的内部设置内部灌注管21，所述内部灌注管21的一端能够进一步延伸到所述手柄组件3中，所述内部灌注管21的另一端与所述头端组件1中的所述灌注孔配合使用，使得所述内部灌注管21中的盐水通过所述灌注孔在患者体内的脉冲消融位置实现盐水灌注功能。Further, as mentioned above, the
进一步地，继续如图1所示，所述手柄组件3包括手柄外壳32，所述手柄外壳32具有人体工学设计，以使得所述手柄外壳32易于握持，在所述手柄外壳32上设置滑动按键31，由于所述头端组件1与所述连接组件2的连接能够配合实现所述头端组件1相对于所述连接组件2的调弯功能，具体地，通过所述手柄组件3上所述滑动按键31的前后滑动，可以实现所述头端组件1实现朝向第一方向或者第二方向以实现调弯，这样便捷的调弯功能易于用户的操作使用，从而使得在消融过程中在不同消融位置满足对于所述脉冲消融装置的头端外形的不同需求。Further, as shown in FIG. 1 , the
进一步地，所述头端组件1的内部具体结构如图2-图5所示，这里的所述头端组件1包括头端外壳12，所述头端外壳12为中空结构，例如可以采用中空的管状结构，也可以根据患者体内脉冲消融位置的不同选择其他合适的结构。Further, the internal specific structure of the head-
为了通过所述头端组件1实现脉冲消融以及盐水灌注的功能，如图2和图4所示，在所述头端外壳12上设置多个电极11，多个所述电极11可以以阵列方式布置，所述电极11用于通电后在患者体内的脉冲消融位置实现脉冲消融功能，所述电极11具体地按照预定阵列方式设置在所述头端外壳12的侧面或者端面上，这里的所述电极11的阵列式设置能够提高脉冲消融过程的快速响应性与稳定性，此外，多电极的设置还能同时提供标测功能，可为手术评估提供参考；进一步地，如图4所示，可以根据所述电极11的位置而对应设置灌注孔15，由于所述电极11可以具有不同的形状和位置，例如对于尺寸较小的电极，所述灌注孔15可以设置在相邻的两个所述电极11之间，对于尺寸较大的电极，可以在所述电极11上设置所述灌注孔15。In order to realize the functions of pulse ablation and saline perfusion through the head-
进一步地，考虑到所述脉冲消融装置的所述头端组件1可以通过所述手柄组件3的操作来实现所述头端组件1的调弯功能，如图2和图3所示，所述头端外壳12的端部通过头端夹片14与所述连接组件2连接，在所述头端外壳12上设置拉索13，其中，所述拉索13的一端设置在所述头端外壳12上，其另一端穿过所述头端夹片14并穿入至所述连接组件2中，这样，用户可以操作所述滑动按键31以通过所述拉索13带动所述头端组件1的弯曲。Further, considering that the head-
具体地，如图4、图5和图6所示，在所述头端外壳12的尾部设置例如圆柱形的连接部18，两个所述拉索13与所述连接部18连接，其中，每个所述拉索13的一端通过例如粘结剂等固定在所述连接部18上，每个所述拉索13的另一端从所述头端外壳12内穿出，穿过所述头端夹片14并延伸至所述连接组件2中。Specifically, as shown in FIG. 4 , FIG. 5 and FIG. 6 , a
所述头端夹片14设置在所述手柄外壳12和所述连接组件2之间，例如这里可以采用两个所述头端夹片14，这两个所述头端夹片14可以相互卡合以扣接在所述拉锁13的外侧，两个所述拉索13相对所述头端夹片14以及在所述连接组件2内为上下对称分布。The head-
进一步地，如图5和图6所示，为了实现在所述头端夹片14在所述头端外壳12和所述连接组件2之间的固定，在所述连接部18上设置凸轴19，所述凸轴19与所述头端组件1的长度方向相互垂直设置，在所述凸轴19的上下两端分别对应一个所述头端夹片14，每一侧对应的所述头端夹片14的第一端部设置圆形的通孔141，所述凸轴19穿过所述通孔141使得所述头端外壳12与所述头端夹片14两者配合安装，从而实现所述头端夹片14与所述头端外壳12之间的固定；在所述头端夹片14的第二端部的内侧设置连接柱142，所述连接柱142能够插入到所述连接组件2上的连接孔上以实现所述头端夹片14与所述连接组件2之间的固定。这样，所述拉索13从两个所述头端夹片14之间穿过以进入所述连接组件2的内部。Further, as shown in FIG. 5 and FIG. 6 , in order to realize the fixation of the head-
进一步地，所述拉索13从所述头端组件1内穿出并在所述连接组件2的内部延伸，为此，所述连接组件2在靠近所述手柄组件3内的对应位置开有缺口，所述拉索13通过对应的两个缺口从上下两个方向从所述连接组件2中穿出，最终延伸至所述手柄组件3中。Further, the
进一步地，如图7和图8所示，所述连接组件2与所述手柄组件3连接并且所述连接组件2的尾部穿入到所述手柄组件3中，其中，在所述手柄外壳32中设置压片33和压片柱331，所述压片33例如采用不锈钢制成，所述连接组件2在所述手柄外壳32中通过所述压片33压紧固定在所述压片柱331上；此外，在所述手柄外壳32内的所述压片柱331上设置安装孔，例如可以通过第一紧固件37和所述安装孔相互配合以将所述连接组件2的尾部固定在所述手柄外壳32的所述压片柱331上。Further, as shown in FIG. 7 and FIG. 8 , the
继续如图7和图8所示，在所述手柄外壳32的内部还设置滑块34和滚轴35，所述滑块34与所述滑动按键31连接，例如所述滑动按键31可以设置在所述滑块34的中部，在所述滑块34内部设有连通孔，所述连接组件2伸入到所述手柄外壳32中并穿过所述滑块34上的所述连通孔，从而使得所述滑块34安装在所述连接组件2上，这样使得所述滑块34与所述连接组件2同轴设置，并且所述滑块34可以在所述连接组件2上左右自由移动，所述滚轴35设置在所述滑块34的远离所述连接组件2的一侧。As shown in Figures 7 and 8, a
进一步地，如图8所示，在所述滑块34的上下两侧分别设置第一凸起结构341，所述第一凸起结构341与对应的所述拉索13连接以用于安装固定所述拉索13；其中，一侧(例如上侧)引出的所述拉索13直接穿入所述滑块34一侧设置的所述第一凸起结构341，通过第二紧固件36将其固定于所述滑块34的一侧；另一侧(例如下侧)引出的所述拉索13向前延伸绕过固定于所述手柄外壳32内部的所述滚轴35，调整方向后穿入所述滑块34另一侧设置的所述第一凸起结构341，通过例如第二紧固件36将其固定于所述滑块34的另一侧。这样，通过调整两侧的所述拉索13在所述滑块34两侧固定位置的长度，使得所述滑块34在左右滑动的极限位置之间调节，两个极限位置对应于所述脉冲消融装置的所述头端组件1向第一方向或者第二方向调弯的极限位置。此外，在所述手柄外壳32上针对所述滑动按键31的行程范围设置对应的指示刻度，用于指示所述头端组件1的弯曲程度。Further, as shown in FIG. 8 , first protruding
此外，继续如图8所示，在所述滑块34靠近所述连接组件2和远离所述连接组件2的方向上设置有四个圆柱形的第二凸起结构342，在所述第二凸起结构342上设置硅胶帽343，所述手柄外壳32内侧在所述滑块34的安装位置的所述第二凸起结构342的两侧设有凹槽344，所述硅胶帽343容纳在所述凹槽344中并与凹槽344之间过盈配合，从而提供所述滑块34相对所述手柄外壳32与所述连接组件2组合体相对移动时的阻尼感。In addition, as shown in FIG. 8 , four cylindrical second protruding
此外，在所述手柄外壳32的内部设置限位凸起39，所述限位凸起39用于限制所述滑动按键31带动内部的所述滑块34的左右行程，这样，当用户手持所述脉冲消融装置的所述手柄组件3时，推动所述滑动按键31能够带动内部的所述滑块34向前或者向后移动，在具体进行调弯时，例如向图7中的左侧推动所述滑动按键31(例如指第一方向)，所述头端组件1向下弯曲，向右推动所述滑动按键31(例如指第一方向)，则所述头端组件1向上弯曲，当所述滑动按键31置于中间位置时，所述头端组件1与所述连接组件2保持水平状态。In addition, a
在一个实施方式中，所述内部灌注管21的另一端与鲁尔接头连接，所述鲁尔接头与外部的灌注泵连接。In one embodiment, the other end of the
进一步地，在另一个实施方式中，如图8所示，所述后端组件4包括外部灌注管41，所述外部灌注管41的一端与所述连接组件2中的所述内部灌注管21连接以向所述头端组件1提供盐水，其另一端与鲁尔接头42连接，所述鲁尔接头42与外部的灌注泵连接。此外，所述后端组件4还包括电气接头43，所述电气接头43通过第三紧固件38固定于手柄组件3的尾部，所述电气接头43的一端与所述手柄组件3中的所述电极11的导线连接，另一端在所述手柄组件3的外部与外部独立的转接线缆连接，通过转接线缆与外部的脉冲消融仪连接，从而实现脉冲消融以及标测等功能。Further, in another embodiment, as shown in FIG. 8 , the
下面重点对于所述头端组件1中的所述电极11和所述灌注孔的设置进行详细说明，在一个实施方式中，所述电极11可以是条状电极，也就是，所述头端外壳12上的所述电极11包含至少一对条状电极，所述电极11通过所述头端外壳12上的安装孔固定在所述头端外壳12的表面(例如侧面或者端面)，在所述头端外壳12的内部所述电极11与导线的一端连接，所述导线的另一端沿着所述头端组件1进入到所述连接组件2中，并延伸至所述手柄组件3内部，最终在所述后端组件4的内部与所述电气接头43连接。The following will focus on the setting of the
这里的所述电极11可以是条状电极，这里的所述条状电极的宽度尺寸较小，可以采用15*2mm规格的长方形电极。针对这种规则分布的尺寸较小的所述电极11，考虑到在所述头端组件1上设置与各所述电极11左右需要对称设置灌注通路，依次在所述头端外壳12上各所述电极11之间开有直径0.5-2mm的所述灌注孔15，优选本实例开孔直径为0.8mm。The
当然，不同的电极的布置方式和尺寸可以与所述灌注孔有多种组合布置方式，在一些具体方式中，如图9(a)、图9(b)和图9(c)所示，在图9(a)示出的实施方式中，对于较大的所述电极，在空间允许情况下，所述灌注孔15可以设置在所述电极11上；在图9(b)示出的实施方式中，对于例如长条形的所述电极11但是所述电极11之间距离较近，同时所述电极11的尺寸较小，在所述电极11上开孔不方便时，所述灌注孔15位于所述电极对的外侧；在图9(c)示出的实施方式中，对于不规则的电极对，所述灌注孔15可以开在所述电极11的四周。Of course, different electrode arrangements and sizes can be arranged in multiple combinations with the perfusion hole, in some specific ways, as shown in Figure 9(a), Figure 9(b) and Figure 9(c), In the embodiment shown in Fig. 9(a), for larger described electrodes, the
为了便于所述连接组件2中的所述内部灌注管21与所述灌注孔15的连接，还可以在所述头端外壳12中设置分配管16，所述分配管16与所述连接组件2中的所述内部灌注管21通过例如热缩管+胶水的方式连接，所述分配管16与所述头端外壳12上多个所述灌注孔15分别连通。In order to facilitate the connection between the
这里的所述分配管16与所述内部灌注管21连接，所述内部灌注管21穿过所述连接组件2和所述手柄组件3的内部，最终向位于所述手柄组件3尾部延伸，最终从所述手柄组件3的尾端引出，最终通过所述鲁尔接头42与外部灌注泵连接。或为更便于安装(手柄后部选择合适长度的灌注管)，所述内部灌注管21从所述手柄组件3的尾端引出后与所述外部灌注管41(根据实际需求调整外部灌注管41的长度)连接，最终通过所述鲁尔接头42与外部灌注泵连接，完成整个盐水灌注通路的设置。The dispensing
此外，为了便于在所述头端外壳12中设置所述分配管16，所述头端外壳12可以通过多个壳体相互组装形成，如图5和图6所示，例如通过第一外壳121和第二外壳122相互拼接组装形成。In addition, in order to facilitate the arrangement of the
进一步地，如图5、图6、图10和图11所示，在所述头端外壳12的内部设置分配管16，所述分配管16的设置方向与所述头端外壳12的长度方向同向。Further, as shown in FIG. 5, FIG. 6, FIG. 10 and FIG. 11, a
在一个实施方式中，所述分配管16可以直接安装于所述内部灌注管21内部，所述分配管16内设置一个至少一个输送腔161，这里的所述输送腔161与所述灌注孔15连通。In one embodiment, the
在一个具体的实施方式中，如图6和图10所示，所述输送腔161可以是多个，当具有多个所述输送腔161的情况下，多个所述输送腔161与所述灌注孔15对应设置。In a specific embodiment, as shown in FIG. 6 and FIG. 10 , there may be
进一步地，所述输送腔161可以通过毛细管17与所述灌注孔15连接，当所述输送腔161为多个时，多个所述毛细管17与所述输送腔161对应连接，以平行于所述分配管16的方式设置，根据实际灌注需求，这里的所述毛细管17能够提供与所述灌注孔15对应孔数的所述输送腔161，这样，每个所述输送腔161单独通过所述毛细管17连接引出至各所述灌注孔15。Further, the
作为一种可选方式，如图5和图11所示，除在所述头端外壳的内部使用所述分配管16中的多个所述输送腔161对应各个所述灌注孔15的方式来实现头端通路以外，还可以由所述分配管16直接通过引出若干毛细管17分别与各个所述灌注孔15连接，适用于所述电极11的排布不规则以及所述灌注孔15开孔位置不规则的情况。为此，在所述分配管17的侧面设置排出孔162，这里的所述排出孔162与所述灌注孔15对应设置，多个毛细管17在所述分配管16侧面的排出孔162和所述灌注孔15之间连接，以垂直于所述分配管16的方式布置，这样能够让对应于各所述电极11的出水量更加均匀，同时安装方便。As an optional way, as shown in Figure 5 and Figure 11, in addition to using a plurality of
本公开实施例的所述脉冲消融装置在执行脉冲消融的过程中通过盐水灌注可以在消融组织表面提供相对湿润的环境，防止因心外膜脂肪阻断电场而影响消融效果，同时能够有效避免在空气环境中电极间高电压导致的电火花的产生，提高心外脉冲消融手术的安全性和有效性。The pulse ablation device according to the embodiment of the present disclosure can provide a relatively moist environment on the surface of the ablated tissue through saline perfusion during the pulse ablation process, preventing the ablation effect from being affected by the epicardial fat blocking the electric field, and effectively avoiding the The generation of electric sparks caused by high voltage between electrodes in the air environment improves the safety and effectiveness of extracardiac pulse ablation.
本公开实施例用于房颤治疗，通过脉冲能量的使用，弥补了射频、冷冻消融在心外科房颤消融领域由于能量特性所带来的不足之处，降低射频消融过程中电极表面温度，从而保证手术过程中不会出现温度过高而导致射频消融中断，提高脉冲消融器具的实用性以及消融手术的安全性和有效性。The embodiment of the present disclosure is used for the treatment of atrial fibrillation. Through the use of pulse energy, it makes up for the shortcomings of radiofrequency and cryoablation in the field of atrial fibrillation ablation in cardiac surgery due to energy characteristics, and reduces the electrode surface temperature during radiofrequency ablation, thereby ensuring Interruption of radiofrequency ablation due to high temperature will not occur during the operation, which improves the practicability of the pulse ablation device and the safety and effectiveness of the ablation operation.
此外，虽然采用特定次序描绘了各操作，但是这不应当理解为要求这些操作以所示出的特定次序或以顺序次序执行来执行。在一定环境下，多任务和并行处理可能是有利的。同样地，虽然在上面论述中包含了若干具体实现细节，但是这些不应当被解释为对本公开的范围的限制。在单独的实施例的上下文中描述的某些特征还可以组合地实现在单个实施例中。相反地，在单个实施例的上下文中描述的各种特征也可以单独地或以任何合适的子组合的方式实现在多个实施例中。In addition, while operations are depicted in a particular order, this should not be understood as requiring that the operations be performed in the particular order shown or performed in sequential order. Under certain circumstances, multitasking and parallel processing may be advantageous. Likewise, while the above discussion contains several specific implementation details, these should not be construed as limitations on the scope of the disclosure. Certain features that are described in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination.
尽管已经采用特定于结构特征和/或方法逻辑动作的语言描述了本主题，但是应当理解所附权利要求书中所限定的主题未必局限于上面描述的特定特征或动作。相反，上面所描述的特定特征和动作仅仅是实现权利要求书的示例形式。Although the subject matter has been described in language specific to structural features and/or methodological acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are merely example forms of implementing the claims.
以上对本公开多个实施例进行了详细说明，但本公开不限于这些具体的实施例，本领域技术人员在本公开构思的基础上，能够做出多种变型和修改实施例，这些变型和修改都应落入本公开所要求保护的范围。Multiple embodiments of the present disclosure have been described in detail above, but the present disclosure is not limited to these specific embodiments. Those skilled in the art can make various variations and modifications on the basis of the concept of the disclosure. These variations and modifications All should fall within the scope of protection claimed by the present disclosure.
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