技术领域Technical Field
本申请涉及肺静脉冷冻消融技术领域，具体涉及一种具有消融记录和球囊定位功能的冷冻消融装置。The present application relates to the technical field of pulmonary vein cryoablation, and in particular to a cryoablation device with ablation recording and balloon positioning functions.
背景技术Background technique
心房颤动是指心律失常，心房颤动发作可能时有时无，也可能持续存在，发生心房颤动时，房颤患者混乱的心律会导致血液在心房蓄积并形成血栓，血栓从心脏区域脱落，可能会进入大脑并导致卒中，所以房颤患者需要接受适当治疗以预防卒中。房颤最初采用抗心律失常药物治疗，随着科技发展，出现了针对肺静脉的导管消融术，导管消融通过在肺静脉周围产生疤痕组织损伤来实现肺静脉的电隔离以阻断异常电信号的传导，这些疤痕组织损伤可通过加热(射频消融)或冷却身体组织(冷冻消融)来产生。越来越多的临床数据证明，冷冻消融的术后心血管住院治疗较少，重复手术的需求率较少，其隔离肺静脉的效果可靠且操作技术更为简单实用，学习曲线短，是预防房颤复发的更有效解决方案。Atrial fibrillation refers to an abnormal heart rhythm. Atrial fibrillation attacks may occur from time to time or may persist. When atrial fibrillation occurs, the chaotic heart rhythm of patients with atrial fibrillation can cause blood to accumulate in the atria and form blood clots. Blood clots break off from the heart area and may enter the brain and cause strokes, so patients with atrial fibrillation need to receive appropriate treatment to prevent strokes. Atrial fibrillation was initially treated with antiarrhythmic drugs. With the development of technology, catheter ablation for pulmonary veins has emerged. Catheter ablation achieves electrical isolation of the pulmonary veins by creating scar tissue damage around the pulmonary veins to block the conduction of abnormal electrical signals. These scar tissue damage can be produced by heating (radiofrequency ablation) or cooling body tissue (cryoablation). More and more clinical data have shown that cryoablation has fewer postoperative cardiovascular hospitalizations and a lower need for repeat surgery. Its effect of isolating pulmonary veins is reliable, and the operation technique is simpler and more practical, with a short learning curve. It is a more effective solution for preventing recurrence of atrial fibrillation.
目前，冷冻消融技术还存在以下问题：在一次手术中，通常需要对四个肺静脉口依次消融，对一个肺静脉口完成一次消融后，需要将冷冻球囊移动至另一个肺静脉口，再次充气进行消融操作，从而一次手术共需要进行多次消融，多次消融会造成医生对已消融和未消融的部位混淆，如果可以记录消融次数，会一定程度避免错误；并且在冷冻消融过程中，需要对球囊进行定位，现有的冷冻球囊有些定位效果也不好，增加了操作难度，且降低消融效果。At present, the cryoablation technology still has the following problems: in one operation, it is usually necessary to ablate the four pulmonary vein openings in turn. After completing one ablation of one pulmonary vein opening, the cryoballoon needs to be moved to another pulmonary vein opening and inflated again for ablation. Therefore, multiple ablations are required in one operation. Multiple ablations will cause doctors to confuse the ablated and non-ablated areas. If the number of ablations can be recorded, errors can be avoided to a certain extent. In addition, during the cryoablation process, the balloon needs to be positioned. The positioning effect of some existing cryoballoons is not good, which increases the difficulty of operation and reduces the ablation effect.
发明内容Summary of the invention
发明目的：本申请旨在克服现有技术缺陷，提供一种具有消融记录和球囊定位功能的冷冻消融装置。Purpose of the invention: This application aims to overcome the defects of the prior art and provide a cryoablation device with ablation recording and balloon positioning functions.
技术方案：一种冷冻消融装置，包括内导管、外导管、球囊以及位于内导管与外导管之间的制冷剂供应管；所述球囊的前端与所述内导管的前端连接，后端与所述外导管的前端连接；所述制冷剂供应管包括输送管以及连接在输送管端部的喷气头，所述喷气头处具有多个喷孔；所述喷气头通过连通管连接有记录管，所述记录管包括管体和与管体端部固定连接的端部板，所述管体与所述喷气头之间通过连接板连接；所述端部板处设置有压力传感器，所述管体内设置有活塞，所述活塞通过弹簧连接有能够按压所述压力传感器的压板；所述连接板具有内腔，所述连接板的内腔与所述管体内空间连通。Technical solution: A cryoablation device, comprising an inner catheter, an outer catheter, a balloon and a refrigerant supply pipe located between the inner catheter and the outer catheter; the front end of the balloon is connected to the front end of the inner catheter, and the rear end is connected to the front end of the outer catheter; the refrigerant supply pipe comprises a delivery pipe and a nozzle connected to the end of the delivery pipe, and the nozzle has a plurality of nozzle holes; the nozzle is connected to a recording tube through a connecting pipe, and the recording tube comprises a tube body and an end plate fixedly connected to the end of the tube body, and the tube body and the nozzle are connected through a connecting plate; a pressure sensor is provided at the end plate, a piston is provided in the tube body, and the piston is connected to a pressure plate capable of pressing the pressure sensor through a spring; the connecting plate has an inner cavity, and the inner cavity of the connecting plate is connected to the space inside the tube body.
进一步地，所述内导管处安装有第一显影环，所述记录管处安装有第二显影环。Furthermore, a first developing ring is installed at the inner guide tube, and a second developing ring is installed at the recording tube.
从而通过两个显影环可以对球囊整体进行显影定位，从而可以很方便地定位球囊角度，便于医生调整球囊角度，使球囊与目标消融区域贴合更加紧密，从而加强封堵效果。The entire balloon can be positioned by using two developing rings, so that the balloon angle can be easily positioned, which makes it easier for doctors to adjust the balloon angle so that the balloon fits more closely with the target ablation area, thereby enhancing the blocking effect.
进一步地，所述连通管为弧形管。Furthermore, the connecting pipe is an arc-shaped pipe.
从而记录管与喷气头之间连接更稳定，且管内气体流通更为顺畅。Thereby, the connection between the recording tube and the nozzle is more stable, and the gas flow in the tube is smoother.
进一步地，所述连接板为柔性连接板。Furthermore, the connecting plate is a flexible connecting plate.
从而在不充入气体时，记录管与喷气头之间的柔性连接板内部气压很小，收缩气囊时，柔性连接板可被压缩，方便收缩球囊导管的体积，从而方便球囊导管的移动；在注射制冷剂时，柔性连接板与记录管内部空间连通，由于内部高压，从而展开使得记录管也被展开，记录管展开后类似活塞筒，一方面活塞的移动更加稳定，从而记录气压的工作更加稳定，另一方面使得两个显影环在空间上展开一定距离，更加有利于对球囊的圆周角度的定位。Therefore, when no gas is filled, the internal air pressure of the flexible connecting plate between the recording tube and the nozzle is very small. When the airbag is deflated, the flexible connecting plate can be compressed, which is convenient for shrinking the volume of the balloon catheter and thus facilitating the movement of the balloon catheter. When the refrigerant is injected, the flexible connecting plate is connected to the internal space of the recording tube. Due to the internal high pressure, the recording tube is unfolded so that the recording tube is also unfolded. After the recording tube is unfolded, it is similar to a piston cylinder. On the one hand, the movement of the piston is more stable, thereby making the work of recording the air pressure more stable. On the other hand, the two developing rings are unfolded a certain distance in space, which is more conducive to positioning the circumferential angle of the balloon.
进一步地，所述内导管外侧壁具有第一凹槽，所述喷气头固定安装于所述第一凹槽处。Furthermore, the outer side wall of the inner conduit has a first groove, and the spray head is fixedly installed in the first groove.
从而制冷剂供应管能够固定安装在内导管处，通过供应管充入气体时更加稳定。Therefore, the refrigerant supply pipe can be fixedly installed on the inner conduit, and the gas is filled more stably through the supply pipe.
进一步地，所述第一凹槽处具有第二凹槽，所述第二凹槽用于安装所述压力传感器的导线。Furthermore, a second groove is provided at the first groove, and the second groove is used for installing a wire of the pressure sensor.
从而保护压力传感器的导线，使压力传感器稳定工作。This protects the wires of the pressure sensor and ensures that the pressure sensor works stably.
进一步地，所述第一显影环位于内导管的前端和喷气头之间；所述第二显影环位于连通管和连接板之间。Furthermore, the first developing ring is located between the front end of the inner guide tube and the spray head; the second developing ring is located between the connecting pipe and the connecting plate.
从而两个显影环在纵向空间上展开一定距离，更加有利于对球囊的圆周角度的定位。Therefore, the two developing rings are spread out a certain distance in the longitudinal space, which is more conducive to the positioning of the circumferential angle of the balloon.
有益效果：1)通过在喷气头处设置记录管，通过内部的压力传感器的信息可实现记录消融的次数，从而每次手术中消融完成的次数持续被记录，避免医生操作出错；Beneficial effects: 1) By setting a recording tube at the nozzle, the number of ablations can be recorded through the information of the internal pressure sensor, so that the number of ablations completed in each operation is continuously recorded to avoid doctor's operation errors;
2)通过设置两个显影环，从而可以对球囊整体进行显影定位；从而通过两个显影环的配合可以记录球囊的圆周方向的方位，从而可以很方便地定位球囊角度，便于医生调整球囊角度，使球囊与目标消融区域贴合更加紧密，从而加强封堵效果；2) By setting two developing rings, the balloon can be positioned as a whole; the circumferential position of the balloon can be recorded by the cooperation of the two developing rings, so that the balloon angle can be easily positioned, which is convenient for doctors to adjust the balloon angle so that the balloon fits more closely with the target ablation area, thereby enhancing the blocking effect;
3)通过在喷气头和记录管之间设置柔性连接板，从而在不充入气体时，柔性连接板可被压缩，方便收缩球囊导管的体积，从而方便球囊导管的移动；在注射制冷剂时，柔性连接板内部高压，从而展开使得记录管也被展开，一方面记录气压的工作更加稳定，另一方面使得两个显影环在空间上展开一定距离，更加有利于对球囊的圆周角度的定位。3) By setting a flexible connecting plate between the nozzle and the recording tube, the flexible connecting plate can be compressed when no gas is filled, so as to facilitate the shrinkage of the volume of the balloon catheter and thus facilitate the movement of the balloon catheter; when the refrigerant is injected, the internal pressure of the flexible connecting plate is high, so that it is unfolded so that the recording tube is also unfolded. On the one hand, the work of recording the air pressure is more stable, and on the other hand, the two developing rings are unfolded a certain distance in space, which is more conducive to the positioning of the circumferential angle of the balloon.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
图1为冷冻球囊整体示意图；FIG1 is an overall schematic diagram of a cryoballoon;
图2为冷冻球囊第一视角示意图；FIG2 is a schematic diagram of a cryoballoon from a first perspective;
图3为A区域放大图；Figure 3 is an enlarged view of area A;
图4为冷冻球囊第二视角示意图；FIG4 is a schematic diagram of a cryoballoon from a second viewing angle;
图5为B区域放大图；Figure 5 is an enlarged view of area B;
其中图2-5为了示意球囊内部结构，对球囊切除了一部分，且对记录管切除了一部分，使得内部示意更加清楚。In order to illustrate the internal structure of the balloon, Figure 2-5 cuts off a part of the balloon and a part of the recording tube to make the internal structure clearer.
具体实施方式Detailed ways
附图标记：1内导管；1.1第一显影环；1.2第一凹槽；1.2.1第二凹槽；2外导管；3球囊；4制冷剂供应管；4.1输送管；4.2喷气头；4.2.1喷孔；6记录管；6.1压板；6.2弹簧；6.3活塞；6.4第二显影环；7连通管；8连接板。Figure numerals: 1 inner conduit; 1.1 first developing ring; 1.2 first groove; 1.2.1 second groove; 2 outer conduit; 3 balloon; 4 refrigerant supply pipe; 4.1 delivery pipe; 4.2 nozzle; 4.2.1 spray hole; 6 recording tube; 6.1 pressure plate; 6.2 spring; 6.3 piston; 6.4 second developing ring; 7 connecting pipe; 8 connecting plate.
如图所示：一种具有消融记录和球囊定位功能的冷冻消融装置，包括内导管1、外导管2、球囊3以及位于内导管1与外导管2之间的制冷剂供应管4；所述球囊3的前端与所述内导管1的前端连接，后端与所述外导管2的前端连接；所述制冷剂供应管4包括输送管4.1以及连接在输送管4.1端部的喷气头4.2，所述喷气头4.2处具有多个喷孔4.2.1；所述喷气头4.2通过连通管7连接有记录管6，所述连通管7为弧形管；所述记录管6包括管体和与管体端部固定连接的端部板，所述管体与所述喷气头4.2之间通过连接板8连接，所述连接板8为柔性连接板；所述端部板处设置有压力传感器，所述管体内设置有活塞6.3，所述活塞6.3通过弹簧6.2连接有能够按压所述压力传感器的压板6.1；所述连接板8具有内腔，所述连接板8的内腔与所述管体内空间连通。As shown in the figure: a cryoablation device with ablation recording and balloon positioning functions, comprising an inner catheter 1, an outer catheter 2, a balloon 3 and a refrigerant supply pipe 4 located between the inner catheter 1 and the outer catheter 2; the front end of the balloon 3 is connected to the front end of the inner catheter 1, and the rear end is connected to the front end of the outer catheter 2; the refrigerant supply pipe 4 comprises a delivery pipe 4.1 and a nozzle 4.2 connected to the end of the delivery pipe 4.1, and the nozzle 4.2 has a plurality of nozzle holes 4.2.1; the nozzle 4.2 is connected to a recording tube 6 through a connecting pipe 7, and the connecting pipe 7 is an arc-shaped tube; the recording tube 6 comprises a tube body and an end plate fixedly connected to the end of the tube body, and the tube body and the nozzle 4.2 are connected by a connecting plate 8, and the connecting plate 8 is a flexible connecting plate; a pressure sensor is arranged at the end plate, a piston 6.3 is arranged in the tube body, and the piston 6.3 is connected to a pressure plate 6.1 capable of pressing the pressure sensor through a spring 6.2; the connecting plate 8 has an inner cavity, and the inner cavity of the connecting plate 8 is connected to the space in the tube body.
所述内导管1处安装有第一显影环1.1，所述记录管6处安装有第二显影环6.4；所述第一显影环1.1位于内导管1的前端和喷气头4.2之间；所述第二显影环6.4位于连通管7和连接板8之间。所述内导管1外侧壁具有第一凹槽1.2，所述喷气头4.2固定安装于所述第一凹槽1.2处。所述第一凹槽1.2处具有第二凹槽1.2.1，所述第二凹槽1.2.1用于安装所述压力传感器的导线。The inner conduit 1 is provided with a first developing ring 1.1, and the recording tube 6 is provided with a second developing ring 6.4; the first developing ring 1.1 is located between the front end of the inner conduit 1 and the nozzle 4.2; the second developing ring 6.4 is located between the connecting tube 7 and the connecting plate 8. The outer wall of the inner conduit 1 has a first groove 1.2, and the nozzle 4.2 is fixedly installed at the first groove 1.2. The first groove 1.2 has a second groove 1.2.1, and the second groove 1.2.1 is used to install the wire of the pressure sensor.
如图所示，本申请的冷冻消融球囊可在开放的三维系统显示球囊位置且记录消融的次数，更加便于医生调整球囊位置，从而更有利于完成对肺静脉口的封堵，加强消融效果。手术时，本申请的冷冻球囊到达肺静脉口后，首先通过制冷剂供应管充入气体，充盈球囊，使球囊封堵肺静脉的血液回流，由于设置有两个显影环，从而可以对球囊整体进行显影定位，从而通过两个显影环的配合可以记录球囊的圆周方向的方位，从而可以很方便地定位球囊角度，便于医生调整球囊角度，使球囊与目标消融区域贴合更加紧密，从而加强封堵效果；确认球囊封堵完毕后，通过制冷剂供应管注入制冷剂(液态N2O)，制冷剂汽化吸热，迅速降低球囊温度，从而对与球囊贴靠的肺静脉组织进行持续时间的低温消融，使其冷冻坏死，从而形成电传导阻滞，实现肺静脉隔离。As shown in the figure, the cryoablation balloon of the present application can display the balloon position and record the number of ablations in an open three-dimensional system, which is more convenient for doctors to adjust the balloon position, thereby being more conducive to completing the occlusion of the pulmonary vein orifice and enhancing the ablation effect. During the operation, after the cryoablation balloon of the present application reaches the pulmonary vein orifice, gas is first filled into the balloon through the refrigerant supply pipe to fill the balloon so that the balloon blocks the blood reflux of the pulmonary vein. Since two developing rings are provided, the balloon can be developed and positioned as a whole, so that the circumferential direction of the balloon can be recorded through the cooperation of the two developing rings, so that the balloon angle can be easily positioned, which is convenient for doctors to adjust the balloon angle so that the balloon fits more closely with the target ablation area, thereby enhancing the occlusion effect; after confirming that the balloon occlusion is completed, refrigerant (liquidN2O ) is injected through the refrigerant supply pipe, and the refrigerant vaporizes and absorbs heat, rapidly reducing the balloon temperature, thereby performing a continuous low-temperature ablation on the pulmonary vein tissue close to the balloon, causing it to freeze necrotize, thereby forming an electrical conduction block and achieving pulmonary vein isolation.
在一次手术中，通常需要对四个肺静脉口依次消融；在对一个肺静脉口完成一次消融后，需要回收冷冻气体，将冷冻球囊移动至另一个肺静脉口，再次充气进行消融操作，因此需要多次充入和排出气体；本申请的冷冻消融球囊设置有记录管与喷气头连通，在充入制冷剂时喷气头持续喷气，从而记录管与喷气头连通，内部气压也较高，较高的气压会驱动活塞，从而使得压板持续按压压力传感器，当压力传感器的测量值持续大于设定阈值设定时间以上时，记录为完成一次消融，从而每次手术中消融完成的次数持续被记录，避免医生操作出错。In one operation, it is usually necessary to ablate the four pulmonary vein openings in sequence; after completing one pulmonary vein opening ablation, it is necessary to recover the cryogenic gas, move the cryoballoon to another pulmonary vein opening, and inflate it again for ablation operation, so it is necessary to fill and discharge the gas multiple times; the cryoablation balloon of the present application is provided with a recording tube connected to the nozzle, and the nozzle head continuously sprays when the refrigerant is filled, so that the recording tube is connected to the nozzle head, and the internal air pressure is also higher. The higher air pressure will drive the piston, so that the pressure plate continuously presses the pressure sensor. When the measured value of the pressure sensor continues to be greater than the set threshold for a set time, it is recorded as a completed ablation, so that the number of ablations completed in each operation is continuously recorded to avoid doctor's operating errors.
另外，不充入气体时，记录管与喷气头之间的柔性连接板内部气压很小，因此收缩球囊时，柔性连接板可被压缩，方便收缩球囊导管的体积，从而方便球囊导管的移动。但是在注射制冷剂时，柔性连接板内部高压，从而展开使得记录管也被展开，记录管展开后类似活塞筒，一方面活塞的移动更加稳定，从而记录气压的工作更加稳定，另一方面使得两个显影环在空间上展开一定距离，更加有利于对球囊的圆周角度的定位。In addition, when no gas is filled, the internal air pressure of the flexible connecting plate between the recording tube and the nozzle is very small. Therefore, when the balloon is deflated, the flexible connecting plate can be compressed, which is convenient for shrinking the volume of the balloon catheter, thereby facilitating the movement of the balloon catheter. However, when the refrigerant is injected, the internal pressure of the flexible connecting plate is high, so that the recording tube is also unfolded when it is unfolded. After the recording tube is unfolded, it is similar to a piston cylinder. On the one hand, the movement of the piston is more stable, so that the work of recording air pressure is more stable. On the other hand, the two developing rings are unfolded a certain distance in space, which is more conducive to the positioning of the circumferential angle of the balloon.
尽管本发明就优选实施方式进行了示意和描述，但本领域的技术人员应当理解，只要不超出本发明的权利要求所限定的范围，可以对本发明进行各种变化和修改。Although the present invention has been illustrated and described with respect to the preferred embodiments, it will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the scope of the present invention as defined by the claims.
| Application Number | Priority Date | Filing Date | Title |
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| CN202311084922.0ACN117137609B (en) | 2023-08-25 | 2023-08-25 | A cryoablation device with ablation recording and balloon positioning functions |
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| CN202311084922.0ACN117137609B (en) | 2023-08-25 | 2023-08-25 | A cryoablation device with ablation recording and balloon positioning functions |
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| CN202311084922.0AActiveCN117137609B (en) | 2023-08-25 | 2023-08-25 | A cryoablation device with ablation recording and balloon positioning functions |
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| CN113331935A (en)* | 2021-06-01 | 2021-09-03 | 黄松群 | Novel atrial fibrillation cryoablation device beneficial to pulmonary vein plugging |
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| CN1774239A (en)* | 2003-01-29 | 2006-05-17 | 埃-皮尔制药公司 | Active drug delivery in the gastrointestinal tract |
| CN103781443A (en)* | 2011-04-13 | 2014-05-07 | 低温疗法有限公司 | Plaque stabilisation using cryoenergy |
| CN108778149A (en)* | 2016-01-04 | 2018-11-09 | 康福乐医疗公司 | System and method for treating MVO |
| CN113573672A (en)* | 2018-12-07 | 2021-10-29 | 雷森斯医疗有限公司 | Cooling device and cooling method |
| CN113331935A (en)* | 2021-06-01 | 2021-09-03 | 黄松群 | Novel atrial fibrillation cryoablation device beneficial to pulmonary vein plugging |
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