技术领域technical field
本实用新型涉及一种肿瘤冷冻消融探针，特别涉及一种用于肺部、脑部、大血管附近等特殊部位肿瘤手术的带扩张球囊的超细肿瘤冷冻消融探针。The utility model relates to a tumor cryoablation probe, in particular to an ultra-fine tumor cryoablation probe with an expansion balloon used for tumor operations on special parts such as the lung, the brain, and the vicinity of large blood vessels.
背景技术Background technique
2014年版《世界癌症报告》预测全球癌症病例将呈现迅猛增长态势，由2012年的1400万人逐年递增至2025年的1900万人，到2035年将达到2400万人；2012年全世界共新增1400万癌症病例并有820万人死亡。其中，中国新增307万癌症患者并造成约220万人死亡，分别占全球总量的21.9%和26.8%。可见，癌症已严重威胁人类的生命和健康。The 2014 edition of the "World Cancer Report" predicts that global cancer cases will show a rapid growth trend, from 14 million in 2012 to 19 million in 2025, and will reach 24 million by 2035; 14 million cancer cases and 8.2 million deaths. Among them, China added 3.07 million cancer patients and caused about 2.2 million deaths, accounting for 21.9% and 26.8% of the global total respectively. It can be seen that cancer has seriously threatened human life and health.
手术切除、放疗、化疗是这三种传统的肿瘤治疗方法对患者伤害很大，严重影响患者生存质量，引发较为广泛的对于肿瘤患者“过度治疗”的争论。同时，因为肿瘤患者身体机能较差等原因，只有大约20%左右的肿瘤患者能够接受外科切除手术，因此，肿瘤微创消融治疗技术正成为当代临床医学发展的前沿。冷冻消融是其中一种具有代表意义的技术，其主要通过低温器械，有控制地使病灶组织经历降温、冻结、复温过程，从而造成肿瘤细胞的不可逆损伤以及坏死。在冷冻消融治疗时，为破坏肿瘤组织，探头要达到足够低的低温，而消融探针非靶向区必须具有良好的绝热性能，以避免冻伤穿刺路径上的正常组织。Surgical resection, radiotherapy, and chemotherapy are the three traditional tumor treatment methods that cause great harm to patients, seriously affect the quality of life of patients, and trigger a wider debate on "overtreatment" of cancer patients. At the same time, only about 20% of tumor patients can receive surgical resection due to poor physical function of tumor patients. Therefore, minimally invasive tumor ablation treatment technology is becoming the forefront of contemporary clinical medicine development. Cryoablation is one of the representative technologies. It mainly uses low-temperature equipment to control the lesion tissue to undergo cooling, freezing, and rewarming processes, thereby causing irreversible damage and necrosis of tumor cells. During cryoablation, in order to destroy tumor tissue, the probe must reach a sufficiently low temperature, and the non-target area of the ablation probe must have good thermal insulation properties to avoid frostbite to normal tissues along the puncture path.
目前世界上最细的冷冻消融探针是Cryo-HITTM伽利略氩氦刀，直径1.47mm，更便于操作，穿刺更容易、更顺畅，对正常组织损伤更小，并发症发生率低，尤其适用于肺部、脑部、大血管附近等特殊部位的肿瘤，临床应用于肺癌时，气胸发生率明显低于2mm探针的气胸发生率。但其存在以下缺点：1.探针内不带温度感应热电偶，需要监测组织内温度，必须另外插入温度探针；2.非靶向区真空绝热壁结构复杂，造价高昂，在外力作用下或较长时间存储，容易造成漏气等现象，影响绝热效果。At present, the thinnest cryoablation probe in the world is the Cryo-HITTM Galileo argon-helium knife, with a diameter of 1.47mm, which is easier to operate, easier and smoother to puncture, less damage to normal tissues, and has a low incidence of complications, especially suitable for For tumors in special parts such as the lung, brain, and near large blood vessels, the incidence of pneumothorax is significantly lower than that of a 2mm probe when it is clinically applied to lung cancer. However, it has the following disadvantages: 1. There is no temperature sensing thermocouple in the probe, and it is necessary to monitor the temperature in the tissue, and a temperature probe must be inserted; 2. The vacuum insulation wall in the non-target area has a complex structure and high cost. Or stored for a long time, it is easy to cause air leakage and other phenomena, which will affect the heat insulation effect.
发明内容Contents of the invention
本实用新型针对现有1.47mm直径的 Cryo-HITTM伽利略氩氦刀不能监测靶组织内温度，非靶向区真空绝热壁造价高昂、容易漏气，无法有效的保护正常组织的缺陷，提供一种带扩张球囊的超细肿瘤冷冻消融探针，该探针直径仅1mm，兼具探针靶向区实时精准测温及非靶向区隔热保温、保护正常组织的功能，能更安全有效的适用于肺部、脑部、大血管附近等特殊部位的肿瘤治疗。The utility model aims at the defect that the existing Cryo-HITTM Galileo argon-helium knife with a diameter of 1.47mm cannot monitor the temperature in the target tissue, and the vacuum insulation wall in the non-target area is expensive, easy to leak, and cannot effectively protect the normal tissue. Ultra-fine tumor cryoablation probe with expansion balloon, the probe is only 1mm in diameter, it has the functions of real-time and accurate temperature measurement in the target area of the probe, heat insulation and heat preservation in the non-target area, and protection of normal tissues, which can be safer and more effective It is suitable for the treatment of tumors in special parts such as the lungs, brain, and near large blood vessels.
本实用新型的技术方案为：一种带扩张球囊的超细肿瘤冷冻消融探针，包括壳体、球囊、薄膜热电偶、绝缘层,其特点是：壳体由一体的靶向区和非靶向区组成，非靶向区固定有球囊，非靶向区尾端设置扩张球囊的充气孔，并配有充气后堵住气体的密封盖。靶向区外壁涂覆有薄膜热电偶，壳体与薄膜热电偶之间涂覆有绝缘层。The technical scheme of the utility model is: an ultra-fine tumor cryoablation probe with an expansion balloon, including a shell, a balloon, a thin-film thermocouple, and an insulating layer. The non-target area is composed of a balloon fixed on the non-target area, and an inflation hole for expanding the balloon is arranged at the end of the non-target area, and is equipped with a sealing cover that blocks the gas after inflation. The outer wall of the target area is coated with a thin-film thermocouple, and an insulating layer is coated between the shell and the thin-film thermocouple.
壳体外径为1mm，并由医用不锈钢或镍铬合金材料制成。The outer diameter of the shell is 1mm, and it is made of medical stainless steel or nickel-chromium alloy.
球囊由聚酰胺类高分子材料、改性聚酰胺高分子材料或高分子复合材料制成。球囊通过热焊接或激光焊接固定在非靶向区上。The balloon is made of polyamide polymer material, modified polyamide polymer material or polymer composite material. The balloon is fixed on the non-targeted area by heat welding or laser welding.
当球囊内通过充气孔充入导热系数低的气体扩张后，其直径可达3-5mm,形状为圆柱形或葫芦状。When the balloon is filled with gas with low thermal conductivity through the inflation hole and expanded, its diameter can reach 3-5mm, and its shape is cylindrical or gourd-shaped.
薄膜热电偶是1～5组测温区间覆盖-200℃～150℃的K型、N型、E型、J型或T型热电偶，并共用一根同种材质的热电极。Thin-film thermocouples are K-type, N-type, E-type, J-type or T-type thermocouples with 1 to 5 groups of temperature measurement ranges covering -200°C to 150°C, and share a thermode of the same material.
绝缘层是SiO2、Al2O3、Parylen或特氟龙涂层。The insulating layer is SiO2 , Al2 O3 , Parylen or Teflon coating.
本实用新型的有益效果在于：The beneficial effects of the utility model are:
1. 1mm超细冷冻消融探针, 便于操作，穿刺更容易、更顺畅，对正常组织损伤更小，并发症发生率低，减轻患者痛苦及医疗风险，即使刺穿血管，冷冻消融后创伤仍能恢复，适用于肺部、脑部、大血管附近等特殊部位的肿瘤手术；1. 1mm ultra-fine cryoablation probe, easy to operate, easier and smoother to puncture, less damage to normal tissues, low incidence of complications, less pain and medical risks for patients, even if the blood vessel is pierced, the trauma remains intact after cryoablation It can recover, and is suitable for tumor surgery in special parts such as the lungs, brain, and near major blood vessels;
2. 当冷冻消融探针插入靶区组织，探针壳体非靶向区的球囊进气后扩张膨胀，形成球囊隔离膜，将探针与正常组织隔离开，球囊内导热系数极低的气体具有保温性能，避免探针壳体因绝热作用不佳而将漏出的冷量或热量直接作用于探针壳体接触的正常组织；2. When the cryoablation probe is inserted into the target tissue, the balloon in the non-target area of the probe shell expands after inhalation, forming a balloon isolation membrane, which isolates the probe from normal tissues, and the thermal conductivity inside the balloon is extremely high. The low gas has thermal insulation performance, which prevents the leaked cold or heat from the probe shell from directly acting on the normal tissue in contact with the probe shell due to poor heat insulation;
3. 消融手术中，薄膜热电偶可实时测量探针靶向区多处位置的温度，提供给医生精准可靠的实际治疗温度，方便医生手术操作，提高消融效果。3. During the ablation operation, the thin-film thermocouple can measure the temperature of multiple positions in the probe target area in real time, providing the doctor with accurate and reliable actual treatment temperature, which is convenient for the doctor to operate and improves the ablation effect.
附图说明Description of drawings
图1是本实用新型的结构示意图；Fig. 1 is the structural representation of the utility model;
图2-1、图2-2是本实用新型直接经皮穿刺插入组织后的剖面结构示意图；Fig. 2-1 and Fig. 2-2 are schematic cross-sectional structure diagrams of the utility model after direct percutaneous puncture into tissue;
图3是本实用新型的薄膜热电偶的结构示意图。Fig. 3 is a structural schematic diagram of the thin film thermocouple of the present invention.
具体实施方式Detailed ways
下面结合附图与实施例对本实用新型作进一步说明。Below in conjunction with accompanying drawing and embodiment the utility model is further described.
如图1所示，一种带扩张球囊的超细肿瘤冷冻消融探针，包括壳体1、球囊2、薄膜热电偶3、绝缘层4。As shown in FIG. 1 , an ultrafine tumor cryoablation probe with an expanding balloon includes a housing 1 , a balloon 2 , a thin-film thermocouple 3 and an insulating layer 4 .
壳体1由一体的靶向区5和非靶向区6组成，所述球囊2固定于冷冻消融探针壳体1的非靶向区6上，非靶向区6尾端设置扩张球囊的充气孔8及密封盖9，所述薄膜热电偶3的接点均位于探针靶向区5内，所述绝缘层4涂覆于壳体1与薄膜热电偶3之间。The housing 1 is composed of an integrated targeting area 5 and a non-targeting area 6, the balloon 2 is fixed on the non-targeting area 6 of the cryoablation probe housing 1, and an expansion ball is arranged at the end of the non-targeting area 6 The inflation hole 8 and the sealing cover 9 of the bag, the junction of the thin-film thermocouple 3 are located in the probe targeting area 5 , and the insulating layer 4 is coated between the casing 1 and the thin-film thermocouple 3 .
如图2-1所示，当探针壳体1直接经皮穿刺插入人体靶区组织7后，探针非靶向区6上固定的球囊2经充气孔8注入氩气，将密封盖9塞住充气孔8，使球囊的扩张至3-5mm的圆柱形，将组织与探针壳体1隔离，避免了正常组织与探针的直接接触。As shown in Figure 2-1, when the probe shell 1 is directly inserted into the human target tissue 7 by percutaneous puncture, the fixed balloon 2 on the probe non-target area 6 is injected with argon gas through the inflation hole 8, and the sealing cap is sealed. 9. Plug the inflation hole 8 to expand the balloon to a cylindrical shape of 3-5mm, isolate the tissue from the probe housing 1, and avoid direct contact between normal tissue and the probe.
如图2-2所示，当探针壳体1直接经皮穿刺插入人体靶区组织7后，探针非靶向区6上固定的球囊2经充气孔8注入氮气，将密封盖9塞住充气孔8，使球囊的扩张至最大直径为3-5mm的葫芦状，将组织与探针壳体1隔离，避免了正常组织与探针的直接接触。As shown in Figure 2-2, when the probe housing 1 is directly inserted into the target tissue 7 of the human body by percutaneous puncture, the balloon 2 fixed on the non-target area 6 of the probe is injected with nitrogen gas through the inflation hole 8, and the sealing cover 9 The inflation hole 8 is plugged to expand the balloon to a gourd shape with a maximum diameter of 3-5mm, to isolate the tissue from the probe housing 1 and avoid direct contact between normal tissue and the probe.
如图3所示，带扩张球囊的超细肿瘤冷冻消融探针的1～5组薄膜热电偶3为共用一根同种材质的热电极10，对应数量的另外一种材质的热电极11连接于共用热电极10位于靶向区5内的不同位置。As shown in Figure 3, 1 to 5 groups of thin-film thermocouples 3 of the ultra-fine tumor cryoablation probe with expansion balloon share one thermode 10 of the same material, and a corresponding number of thermodes 11 of another material The electrodes 10 connected to the common thermode are located at different positions within the targeting area 5 .
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420292995.9UCN204121161U (en) | 2014-06-05 | 2014-06-05 | With the ultra-fine tumor cryoablation probe of dilating sacculus |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201420292995.9UCN204121161U (en) | 2014-06-05 | 2014-06-05 | With the ultra-fine tumor cryoablation probe of dilating sacculus |
| Publication Number | Publication Date |
|---|---|
| CN204121161Utrue CN204121161U (en) | 2015-01-28 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201420292995.9UExpired - LifetimeCN204121161U (en) | 2014-06-05 | 2014-06-05 | With the ultra-fine tumor cryoablation probe of dilating sacculus |
| Country | Link |
|---|---|
| CN (1) | CN204121161U (en) |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640642A (en)* | 2016-04-07 | 2016-06-08 | 上海导向医疗系统有限公司 | Internal-cooling microwave ablation needle provided with implanted balloon |
| CN110192910A (en)* | 2018-02-25 | 2019-09-03 | 鄂有国 | Separation adjacent tissue type percutaneous puncture ablation device can be protected |
| CN110338902A (en)* | 2019-08-08 | 2019-10-18 | 深圳北芯生命科技有限公司 | Balloons and Medical Systems |
| CN114502090A (en)* | 2019-08-21 | 2022-05-13 | 维兰医疗技术公司 | Ablation Monitoring Systems and Methods |
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105640642A (en)* | 2016-04-07 | 2016-06-08 | 上海导向医疗系统有限公司 | Internal-cooling microwave ablation needle provided with implanted balloon |
| CN105640642B (en)* | 2016-04-07 | 2018-01-12 | 上海导向医疗系统有限公司 | Interior cooled microwave ablation needle with dilating sacculus |
| CN110192910A (en)* | 2018-02-25 | 2019-09-03 | 鄂有国 | Separation adjacent tissue type percutaneous puncture ablation device can be protected |
| CN110338902A (en)* | 2019-08-08 | 2019-10-18 | 深圳北芯生命科技有限公司 | Balloons and Medical Systems |
| CN114502090A (en)* | 2019-08-21 | 2022-05-13 | 维兰医疗技术公司 | Ablation Monitoring Systems and Methods |
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| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CX01 | Expiry of patent term | Granted publication date:20150128 | |
| CX01 | Expiry of patent term |