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 specifically 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 episodes may come and go, or may persist. When atrial fibrillation occurs, the chaotic heart rhythm of atrial fibrillation patients will cause blood to accumulate in the atrium and form thrombus. The thrombus may break off from the heart area and may enter the heart. brain and cause stroke, so people with atrial fibrillation need to receive appropriate treatment to prevent stroke. Atrial fibrillation was initially treated with antiarrhythmic drugs. With the development of science and technology, catheter ablation of pulmonary veins appeared. Catheter ablation achieves electrical isolation of 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 created by heating (radiofrequency ablation) or cooling body tissue (cryoablation). More and more clinical data prove that cryoablation results in less postoperative cardiovascular hospitalization and less need for repeated surgeries. It is reliable in isolating pulmonary veins, has simpler and more practical operating techniques, and has a short learning curve. It is an ideal choice for preventive surgery. A more effective solution for tremor recurrence.
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。Currently, cryoablation technology still has the following problems: In one operation, four pulmonary vein ostia usually need to be ablated sequentially. After completing an ablation of one pulmonary vein ostium, the cryoballoon needs to be moved to another pulmonary vein ostium and inflated again for ablation. Therefore, one operation requires multiple ablations. Multiple ablations will cause the doctor to confuse the ablated and unablated parts. If the number of ablation can be recorded, errors will be avoided to a certain extent; and during the cryoablation process, the ball needs to be 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Contents 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 shortcomings of the existing technology 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, including 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 Connected to the front end of the outer conduit; the refrigerant supply pipe includes a delivery pipe and a jet head connected to the end of the delivery pipe, the jet head has a plurality of nozzle holes; the jet head is connected to a record through a connecting pipe tube, the recording tube includes a tube body and an end plate fixedly connected to the end of the tube body, the tube body and the jet head are connected through a connecting plate; the end plate is provided with a pressure sensor, so A piston is provided in the tube, 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.
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。Further, a first developing ring is installed at the inner conduit, 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。Therefore, the entire balloon can be developed and positioned through the two developing rings, so that the angle of the balloon can be easily positioned, making it easier for the doctor to adjust the angle of the balloon so that the balloon and the target ablation area fit more closely, thereby enhancing the blocking effect.
进一步地，所述连通管为弧形管。Further, the communication 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。As a result, the connection between the recording tube and the jet head 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。Further, the connecting board is a flexible connecting board.
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 the gas is not inflated, the internal air pressure of the flexible connecting plate between the recording tube and the air jet head is very small. When the air bag is deflated, the flexible connecting plate can be compressed to facilitate shrinking the volume of the balloon catheter, thereby facilitating the movement of the balloon catheter. ; When injecting refrigerant, the flexible connecting plate is connected to the internal space of the recording tube. Due to the internal high pressure, the recording tube is also expanded. When the recording tube is expanded, it is similar to a piston barrel. On the one hand, the movement of the piston is more stable, thereby recording the air pressure. The work is more stable. On the other hand, the two developing rings are spread out to 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。Further, the outer wall of the inner conduit has a first groove, and the air jet head is fixedly installed at 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 at the inner conduit, and it is more stable when gas is filled 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。Further, the first groove has a second groove, and the second groove is used to install the 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。Thereby protecting the wire of the pressure sensor and making the pressure sensor work 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。Further, the first developing ring is located between the front end of the inner conduit and the air jet head; the second developing ring is located between the connecting tube 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 to a certain distance in the longitudinal space, which is more conducive to positioning 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 arranging a recording tube at the jet head, the number of ablation times can be recorded through the information of the internal pressure sensor, so that the number of ablation 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 up two developing rings, the entire balloon can be developed and positioned; thus, the circumferential direction of the balloon can be recorded through the cooperation of the two developing rings, so that the angle of the balloon can be easily positioned and adjusted by the doctor. The angle of the balloon makes the balloon fit more closely to the target ablation area, thus 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 arranging a flexible connecting plate between the jet head and the recording tube, the flexible connecting plate can be compressed when the gas is not filled, which facilitates shrinking the volume of the balloon catheter and thus facilitates the movement of the balloon catheter; in injection refrigeration When spraying, the internal high pressure of the flexible connecting plate expands and the recording tube is also expanded. On the one hand, the recording of air pressure is more stable, and on the other hand, the two developing rings are expanded to a certain distance in space, which is more conducive to the circumference of the balloon. Angle positioning.
附图说明Description of the drawings
图1为冷冻球囊整体示意图；Figure 1 is an overall schematic diagram of the cryoballoon;
图2为冷冻球囊第一视角示意图；Figure 2 is a schematic diagram of the 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；Figure 4 is a schematic diagram of the cryoballoon from a second perspective;
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 Figure 2-5, in order to illustrate the internal structure of the balloon, part of the balloon and part of the recording tube are removed to make the internal diagram 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。Reference signs: 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 jet head; 4.2.1 Nozzle hole; 6 recording tube; 6.1 pressure plate; 6.2 spring; 6.3 piston; 6.4 second developing ring; 7 communication tube; 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, including an inner catheter 1, an outer catheter 2, a balloon 3, and a refrigerant supply tube 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 conduit 1, and the rear end is connected to the front end of the outer conduit 2; the refrigerant supply pipe 4 includes a delivery pipe 4.1 and an air jet connected to the end of the delivery pipe 4.1. Head 4.2, the jet head 4.2 has a plurality of nozzle holes 4.2.1; the jet head 4.2 is connected to a recording tube 6 through a connecting tube 7, and the communicating tube 7 is an arc-shaped tube; the recording tube 6 includes a tube body and an end plate fixedly connected to the end of the pipe body. The pipe body and the air jet head 4.2 are connected through a connecting plate 8. The connecting plate 8 is a flexible connecting plate; the end plate is provided with A pressure sensor, a piston 6.3 is provided 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 pressure sensor. The space inside the tube is connected.
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。A first developing ring 1.1 is installed at the inner duct 1, and a second developing ring 6.4 is installed at the recording tube 6; the first developing ring 1.1 is located between the front end of the inner duct 1 and the air jet head 4.2; The second developing ring 6.4 is located between the communication tube 7 and the connecting plate 8. The outer wall of the inner conduit 1 has a first groove 1.2, and the air jet head 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 in an open three-dimensional system and record the number of ablation times, making it easier for doctors to adjust the balloon position, which is more conducive to completing the blocking of the pulmonary vein ostia and strengthening ablation. Effect. During the operation, after the cryoballoon of the present application reaches the pulmonary vein opening, gas is first inflated through the refrigerant supply pipe to fill the balloon, so that the balloon blocks the blood reflux of the pulmonary vein. Since there are two developing rings, the balloon can be The whole capsule is developed and positioned, so that the circumferential orientation of the balloon can be recorded through the cooperation of the two developing rings, so that the angle of the balloon can be easily positioned, allowing the doctor to adjust the angle of the balloon so that the balloon fits the target ablation area. Tighter, thereby enhancing the sealing effect; after confirming that the balloon is blocked, inject refrigerant (liquid N2 O) through the refrigerant supply pipe. The refrigerant vaporizes and absorbs heat, quickly reducing the temperature of the balloon, thus sealing the balloon. The underlying pulmonary vein tissue undergoes sustained low-temperature ablation to cause cryo-necrosis, thereby forming 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, four pulmonary vein ostiums usually need to be ablated sequentially; after completing an ablation of one pulmonary vein ostium, the cryogenic gas needs to be recovered, the cryoballoon needs to be moved to another pulmonary vein ostium, and inflated again to perform the ablation operation, so multiple steps are required. The cryoablation balloon of this application is equipped with a recording tube connected to the air jet head. When the refrigerant is filled, the air jet head continues to inject air. Therefore, the recording tube is connected to the air jet head, and the internal air pressure is also relatively high. The air pressure will drive the piston, so that the pressure plate continues to press the pressure sensor. When the measured value of the pressure sensor continues to be greater than the set threshold for more than the set time, it is recorded as a completed ablation, so the number of completed ablations in each operation is continuously recorded. Avoid medical 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 the gas is not inflated, the internal air pressure of the flexible connecting plate between the recording tube and the injector head is very small. Therefore, when the balloon is deflated, the flexible connecting plate can be compressed, which facilitates shrinking the volume of the balloon catheter and thus facilitates the balloon catheter. of movement. However, when refrigerant is injected, the internal high pressure of the flexible connecting plate expands and the recording tube is also expanded. After the recording tube is expanded, it resembles a piston barrel. 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 recording tube is also expanded. The two developing rings are spread out at a certain distance in space, which is more conducive to positioning 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 in terms of preferred embodiments, those skilled in the art will understand that various changes and modifications can be made to the present invention as long as it does not exceed the scope defined by the claims of the present invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311084922.0ACN117137609B (en) | 2023-08-25 | 2023-08-25 | A cryoablation device with ablation recording and balloon positioning functions |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311084922.0ACN117137609B (en) | 2023-08-25 | 2023-08-25 | A cryoablation device with ablation recording and balloon positioning functions |
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| CN117137609Atrue CN117137609A (en) | 2023-12-01 |
| CN117137609B CN117137609B (en) | 2024-04-05 |
| Application Number | Title | Priority Date | Filing Date |
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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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| 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 |
| US20150018809A1 (en)* | 2013-07-15 | 2015-01-15 | Medtronic Cryocath Lp | Heated electrodes for continued visualization of pulmonary vein potentials |
| US20150250524A1 (en)* | 2014-03-07 | 2015-09-10 | Medtronic Ardian Luxembourg S.A.R.L. | Monitoring and Controlling Internally Administered Cryotherapy |
| CN108778149A (en)* | 2016-01-04 | 2018-11-09 | 康福乐医疗公司 | System and method for treating MVO |
| US20210169545A1 (en)* | 2019-12-06 | 2021-06-10 | Medtronic Cryocath Lp | Active pressure control and method of fault monitoring |
| 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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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1774239A (en)* | 2003-01-29 | 2006-05-17 | 埃-皮尔制药公司 | Active drug delivery in the gastrointestinal tract |
| US20050215989A1 (en)* | 2004-03-23 | 2005-09-29 | Cryocath Technologies Inc. | Method and apparatus for inflating and deflating balloon catheters |
| CN103781443A (en)* | 2011-04-13 | 2014-05-07 | 低温疗法有限公司 | Plaque stabilisation using cryoenergy |
| US20150018809A1 (en)* | 2013-07-15 | 2015-01-15 | Medtronic Cryocath Lp | Heated electrodes for continued visualization of pulmonary vein potentials |
| US20150250524A1 (en)* | 2014-03-07 | 2015-09-10 | Medtronic Ardian Luxembourg S.A.R.L. | Monitoring and Controlling Internally Administered Cryotherapy |
| 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 |
| US20210169545A1 (en)* | 2019-12-06 | 2021-06-10 | Medtronic Cryocath Lp | Active pressure control and method of fault monitoring |
| 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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| CN117137609B (en) | 2024-04-05 |
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