技术领域technical field
本发明涉及一种医疗器械，特别涉及一种局部循环式血栓取除器。The invention relates to a medical device, in particular to a partial circulation thrombus remover.
背景技术Background technique
由于饮食结构改变等原因，人们血栓病的发病率呈现增高趋势，尤其是下肢深静脉血栓病例越来越多。静脉血栓沉积会造成血流障碍和淤滞，从而在静脉血管内形成血栓性静脉炎症。对于慢性髂股静脉血栓患者，静脉血栓会导致下肢长期肿胀，静脉曲张，破溃不愈等。另外，静脉血栓脱落后还可能会转移到身体其他部位和脏器，从而导致严重的并发症。例如，静脉中的血栓通过静脉血管转移并在肺部沉积，可造成肺栓塞，导致患者死亡。血栓病的治疗方法有：1、内科治疗，主要采用抗凝、溶栓等药物治疗。药物治疗偶尔会出现流血或出血等症状；另外，对某些紧急病例，采用药物疗法速度太慢。2、外科手术治疗，在血管上有血栓沉积的部位开一个切口，经由该切口取出血栓。手术治疗对于深静脉血栓患者难度及创伤大；而且，取栓过程本身就有可能导致残余血栓块进入肺部，从而引起致命的肺栓塞。3、介入治疗，可采用经皮穿刺的方式，通过患者体表一个微小的切口将专门的微创介入手术器械引入静脉，在X光透视下直接进行接触溶栓和除栓。与常规的外科手术治疗相比，介入治疗创伤更小，受静脉血栓沉积部位深度的影响更小。Due to changes in dietary structure and other reasons, the incidence of thrombosis in people is on the rise, especially the number of cases of deep vein thrombosis in the lower extremities is increasing. Thrombus deposition in veins can cause blood flow disturbance and stasis, resulting in thrombophlebitis within the veins. For patients with chronic iliofemoral vein thrombosis, venous thrombosis can lead to long-term swelling of the lower limbs, varicose veins, and ulceration. In addition, after the venous thrombus falls off, it may also transfer to other parts and organs of the body, resulting in serious complications. For example, a thrombus in a vein travels through the vein and deposits in the lung, causing a pulmonary embolism that can lead to death. Therapeutic methods for thrombosis include: 1. Internal medicine treatment, mainly adopting anticoagulant, thrombolytic and other drug treatments. Occasionally, bleeding or hemorrhage is associated with medical treatment; in addition, in some urgent cases, the introduction of medical treatment is too slow. 2. Surgical treatment, an incision is made in the blood vessel where the thrombus is deposited, and the thrombus is taken out through the incision. Surgical treatment is difficult and traumatic for patients with deep vein thrombosis; moreover, the thrombus removal process itself may cause residual thrombus to enter the lungs, causing fatal pulmonary embolism. 3. Interventional treatment, percutaneous puncture can be used to introduce special minimally invasive interventional surgical instruments into the vein through a tiny incision on the patient's body surface, and directly contact thrombolysis and thrombus removal under X-ray fluoroscopy. Compared with conventional surgical treatment, interventional treatment is less invasive and less affected by the depth of venous thrombosis.
经对现有技术的文献检索发现，专利号为ZL200320121061.0的中国实用新型专利《静脉取栓管》(授权公告号为CN2659350Y)公开了一种静脉取栓管。该专利由通管丝、取栓管及球囊3部分构成，优点为可取出四肢深静脉血栓而不损伤静脉瓣膜。专利号为ZL96245233.5的中国实用新型专利《血管取栓导管》(授权公告号为CN2268496Y)公开了一种血管取栓导管。该专利实际上为一种双腔导管，其中一腔连结球囊，用于供应液体或气体使球囊膨胀；另一腔用于血液喷流。该专利的优点为可自动判别导管头端是否到达血栓位置。该两专利均采用一个球囊执行刮除血栓的功能。对于某些陈旧性血栓，可能很难实现一次性刮除，这样就需要重新插入导管，膨 胀球囊后再次刮除残余血栓，很容易导致部分碎小的血栓块残余在血管内而不能被彻底取出。It is found through document retrieval of the prior art that the Chinese utility model patent "Venous Thrombectomy Tube" (authorized announcement number CN2659350Y) with the patent number ZL200320121061.0 discloses a vein thrombus retrieval tube. This patent consists of 3 parts: a stylet, a thrombus removal tube, and a balloon. The advantage is that deep vein thrombosis can be removed from the extremities without damaging the venous valve. The Chinese utility model patent "vascular thrombus retrieval catheter" (authorized announcement number CN2268496Y) with the patent number ZL96245233.5 discloses a blood vessel thrombus retrieval catheter. The patent is actually a dual-lumen catheter, one of which is connected to a balloon for supplying liquid or gas to inflate the balloon; the other lumen is used for blood jet flow. The advantage of this patent is that it can automatically judge whether the tip of the catheter has reached the position of the thrombus. These two patents all adopt a balloon to perform the function of scraping thrombus. For some old thrombus, it may be difficult to achieve one-time scraping, so that the catheter needs to be reinserted, and the residual thrombus is scraped off again after the balloon is inflated, which can easily lead to some broken thrombus remaining in the blood vessel and cannot be completely removed take out.
专利号为ZL200820098250.3的中国实用新型专利《用于治疗血栓的滑动式组合导管》(授权公告号为CN201192520Y)公开了一种用于治疗血栓的滑动式组合导管。该专利由一个芯管和一个套管构成，芯管和套管头端分别连结一个球囊。该专利拟通过套管头端球囊的来回拖动来刮除血栓。该专利的优点是采用两个球囊分别实现血管临时封堵和血栓刮除的功能，从而减小了碎小血栓块残余的几率。The Chinese utility model patent "Sliding Combined Catheter for Treating Thrombosis" (authorized announcement number CN201192520Y) with patent number ZL200820098250.3 discloses a sliding combined catheter for treating thrombus. This patent consists of a core tube and a sleeve tube, and the head ends of the core tube and the sleeve tube are connected with a balloon respectively. This patent intends to scrape off the thrombus by dragging the balloon at the head end of the cannula back and forth. The advantage of this patent is that two balloons are used to respectively realize the functions of temporary occlusion of blood vessels and scraping of thrombus, thereby reducing the probability of remaining broken small thrombus.
申请号为92106702.X的中国发明专利《取体内脏器血管栓子的导管》(公开号为CN1072867A)公开了一种取体内脏器血管栓子的导管。该专利由一个带有球囊的内导管和一个带有喇叭口并开设有侧孔的外套管构成。该专利可在刮除血栓的过程中不阻断血流。但是，该专利的喇叭口为一大小固定的硬性结构，不能适应不同患者血管的粗细不等，另外，这种硬性结构不利于外套管头端与人体血管接触部位的密封，再加上喇叭口附近还开有一些侧孔，这些原因都将导致部分碎小的血栓块残余在血管内而不能被彻底取出。Application No. is 92106702.X's Chinese invention patent "catheter for removing internal organ vascular embolus" (publication number is CN1072867A) discloses a kind of catheter for obtaining internal organ vascular embolus. This patent consists of an inner catheter with a balloon and an overtube with a bell mouth and a side hole. This patent can not block the blood flow in the process of scraping off the thrombus. However, the bell mouth of this patent is a rigid structure with a fixed size, which cannot adapt to the thickness of blood vessels of different patients. There are also some side holes in the vicinity, and these reasons will cause some broken and small thrombus to remain in the blood vessel and cannot be completely removed.
以上4个专利中，直接执行血栓刮除功能的元件均为球囊。球囊本身为弹性元件，且表面光滑，再加上人体血管壁具有一定的弹性，这使得在执行血栓刮除的过程中血管和球囊均会发生一定程度的“退让”。导致某些血栓，尤其是陈旧性血栓并不能被彻底地刮除。In the above four patents, the components that directly perform the thrombus scraping function are all balloons. The balloon itself is an elastic element with a smooth surface, and the human blood vessel wall has a certain degree of elasticity, which makes both the blood vessel and the balloon "give back" to a certain extent during the thrombus scraping. Some thrombi, especially old ones, cannot be completely scraped off.
专利号为ZL200620164685.4的中国实用新型专利《取栓器》(授权公告号为CN201042451Y)公开了一种取栓器。该专利采用由记忆合金丝构成的伞状结构进行血栓刮除，采用套管将刮除后的血栓排出体外。该专利采用金属丝而非球囊进行血栓刮除，可提高刮除效果。但是，金属丝同时也有可能刮伤血管内壁。The Chinese utility model patent "thrombosis remover" (authorized announcement number CN201042451Y) with the patent number of ZL200620164685.4 discloses a kind of thrombus retriever. The patent adopts an umbrella structure made of memory alloy wire to scrape thrombus, and uses a sleeve to discharge the scraped thrombus out of the body. The patent uses a metal wire instead of a balloon for thrombus scraping, which can improve the curettage effect. However, the wire also has the potential to scratch the lining of the blood vessel.
上述的现有技术在以下3个方面尚存在不足：1、对于栓核或陈旧性血栓取除效果不理想，取除率低；2、取栓过程损伤血管内膜，容易形成继发性血栓；3、取拴过程中产生的血栓碎粒部分残留在血液内部进入旁路动脉和脏器，可能导致相关脏器发生栓塞或功能衰竭；4、取栓过程中正常血液流失多，易导致病人贫血。The above-mentioned prior art still has deficiencies in the following three aspects: 1. The effect of removing thrombus or old thrombus is not ideal, and the removal rate is low; 2. The intima of the blood vessel is damaged during thrombus removal, and secondary thrombus is easily formed ;3. Part of the thrombus fragments produced during the thrombus removal process remains in the blood and enters the bypass arteries and organs, which may lead to embolism or functional failure of related organs; anemia.
发明内容Contents of the invention
本发明的目的，就是为了解决上述问题，提供一种局部循环式血栓取除器。The object of the present invention is to provide a partial circulation thrombus remover in order to solve the above problems.
为了达到上述目的，本发明采用了以下技术方案：一种局部循环式血栓取除器，其包括：In order to achieve the above object, the present invention adopts the following technical solutions: a partial circulation thrombus remover, which includes:
用于打碎血栓的叶轮组件；impeller assembly for breaking up thrombus;
头端保护管，其套装在叶轮组件的头端；The head end protection tube is sleeved on the head end of the impeller assembly;
内管，其套装在叶轮组件外并与头端保护管的后部嵌套相连，在内管与叶轮组件之间形成第一环腔；An inner tube, which is sleeved outside the impeller assembly and nested with the rear of the head-end protection tube to form a first annular cavity between the inner tube and the impeller assembly;
外管，其套装在内管外，在外管与内管之间形成第二环腔；The outer tube is sleeved outside the inner tube to form a second annular cavity between the outer tube and the inner tube;
第一Y形阀，其套装在外管的后部，前端与外管的后端相连，第一Y形阀上设有用于与补液泵连接的补液接头，该补液接头与第二环腔连通；The first Y-shaped valve is set on the rear part of the outer pipe, and the front end is connected to the rear end of the outer pipe. The first Y-shaped valve is provided with a liquid replenishing joint for connecting with the liquid replenishing pump, and the liquid replenishing joint communicates with the second annular cavity;
第二Y形阀，其套装在第一Y形阀后，前端与内管的后端相连，第二Y形阀上设有用于与抽栓泵连接的排栓接头，该排栓接头与第一环腔连通。The second Y-shaped valve is set behind the first Y-shaped valve, and the front end is connected with the rear end of the inner pipe. The second Y-shaped valve is provided with a bolt-discharging joint for connecting with the bolt pump, and the bolt-discharging joint is connected with the first Y-shaped valve. A ring cavity is connected.
一用于与电机传动相连的传动方轴；a drive square shaft for connecting with the motor drive;
一连接在传动方轴前方的传动轴；a drive shaft connected to the front of the drive square shaft;
一连接在传动轴前方的叶轮转轴；an impeller shaft connected in front of the transmission shaft;
一安装在叶轮转轴前端的叶轮；- an impeller mounted on the front end of the impeller shaft;
所述叶轮转轴及安装于其上的叶轮被封闭在头端保护管内，叶轮转轴与头端保护管之间设有定位轴承。The rotating shaft of the impeller and the impeller installed thereon are enclosed in the head end protection tube, and a positioning bearing is arranged between the impeller rotating shaft and the head end protection tube.
所述头端保护管的前端开口形成吸栓口，头端保护管的侧壁分别设有泄压口和排栓口，泄压口和排栓口分别位于所述定位轴承的前后。The front end opening of the head-end protection tube forms a plug suction port, and the side walls of the head-end protection tube are respectively provided with a pressure relief port and a plug discharge port, and the pressure relief port and the plug discharge port are respectively located at the front and back of the positioning bearing.
所述内管的前端设有扩径部，所述头端保护管的后部与该扩径部嵌套相连，所述外管的前端端口位于内管的扩径部之后并与内管之间形成补液口。The front end of the inner tube is provided with an enlarged diameter part, the rear part of the head-end protection tube is nested and connected with the enlarged diameter part, and the front end port of the outer tube is located behind the enlarged diameter part of the inner tube and connected to the inner tube. A rehydration port is formed between them.
所述第一Y形阀后端与内管之间设有用于防止补液渗漏的第一密封圈；所述第二Y形阀与叶轮传动轴之间设有用于防止排出液渗漏的第二密封圈。A first sealing ring is provided between the rear end of the first Y-shaped valve and the inner pipe to prevent the leakage of replenishment liquid; a second sealing ring is provided between the second Y-shaped valve and the impeller drive shaft to prevent the leakage of the discharge liquid. Two sealing rings.
本发明的局部循环式血栓取除器刮除血栓彻底、可防止损伤静脉内膜、可将血栓彻底排出体外，避免碎小血栓块在人体内的残留。本发明适合用于人体四肢静脉血栓的刮除，尤其适合采用经皮微创手术技术进行人体股静脉深处血栓的刮除。The partial circulation thrombus remover of the present invention scrapes thrombus completely, can prevent damage to the vein intima, can completely discharge thrombus from the body, and avoids the residue of broken small thrombus in the human body. The invention is suitable for the scraping of the thrombus in the veins of the extremities of the human body, and is especially suitable for scraping the deep thrombus in the femoral vein of the human body by adopting percutaneous minimally invasive surgery technology.
附图说明Description of drawings
图1是本发明局部循环式血栓取除器的整体结构示意图；Fig. 1 is a schematic diagram of the overall structure of the partial circulation thrombus remover of the present invention;
图2是本发明局部循环式血栓取除器的头端结构示意图；Fig. 2 is a schematic diagram of the head end structure of the partial circulation thrombus remover of the present invention;
图3是本发明局部循环式血栓取除器的尾端结构示意图；Fig. 3 is a schematic diagram of the tail end structure of the partial circulation thrombus remover of the present invention;
图4是本发明局部循环式血栓取除器的头端剖视结构示意图；Fig. 4 is a schematic diagram of the sectional structure of the head end of the partial circulation thrombus remover of the present invention;
图5是本发明中的头端保护管结构示意图；Fig. 5 is a schematic structural view of the head end protection tube in the present invention;
图6是本发明中的叶轮组件结构示意图；Fig. 6 is a schematic structural view of the impeller assembly in the present invention;
图7是本发明局部循环式血栓取除器的工作状态示意图；Fig. 7 is a schematic diagram of the working state of the partial circulation thrombus remover of the present invention;
图8是本发明局部循环式血栓取除器的工作原理示意图。Fig. 8 is a schematic diagram of the working principle of the partial circulation thrombus remover of the present invention.
具体实施方式detailed description
参见图1，配合参见图2-图6，本发明的局部循环式血栓取除器，包括：用于打碎血栓的叶轮组件1、头端保护管2、内管3、外管4、第一Y形阀5和第二Y形阀6。Referring to Fig. 1, and referring to Fig. 2-Fig. 6, the partial circulation thrombus remover of the present invention includes: an impeller assembly 1 for crushing a thrombus, a head end protection tube 2, an inner tube 3, an outer tube 4, a second A Y-valve 5 and a second Y-valve 6.
配合参见图6、图3，上述用于打碎血栓的叶轮组件1进一步包括：一用于与电机传动相连的传动方轴11，一连接在传动方轴前方的传动轴12、一连接在传动轴前方的叶轮转轴13、一安装在叶轮转轴前端的叶轮14。Referring to Fig. 6 and Fig. 3, the above-mentioned impeller assembly 1 for crushing thrombus further includes: a transmission square shaft 11 connected to the motor drive, a transmission shaft 12 connected in front of the transmission square shaft, a transmission shaft 12 connected in front of the transmission shaft The impeller rotating shaft 13 of axle place, one is installed on the impeller 14 of impeller rotating shaft front end.
配合参见图4、图5，头端保护管2套装在叶轮组件的头端，该头端保护管的前端开口形成吸栓口21，头端保护管的侧壁分别设有泄压口22和排栓口23，叶轮转轴与头端保护管之间设有定位轴承24，泄压口和排栓口分别位于定位轴承的前后。叶轮转轴13及安装于其上的叶轮14被封闭在头端保护管内。Referring to Fig. 4 and Fig. 5, the head end protection tube 2 is set on the head end of the impeller assembly. A bolt discharge port 23, a positioning bearing 24 is arranged between the impeller rotating shaft and the head end protection tube, and the pressure relief port and the bolt discharge port are respectively located at the front and rear of the positioning bearing. The impeller rotating shaft 13 and the impeller 14 installed thereon are enclosed in the head end protection tube.
内管3套装在叶轮组件1外并与头端保护管2的后部嵌套相连，在内管与叶轮组件之间形成第一环腔7。在内管3的前端设有扩径部，头端保护管2的后部与该扩径部嵌套相连。外管4套装在内管3外，在外管与内管之间形成第二环腔8；外管4的前端端口位于内管的扩径部之后并与内管之间形成补液口41。The inner tube 3 is sleeved on the outside of the impeller assembly 1 and nestedly connected with the rear part of the head-end protection tube 2, and a first annular chamber 7 is formed between the inner tube and the impeller assembly. The front end of the inner tube 3 is provided with an enlarged diameter portion, and the rear portion of the head end protection tube 2 is nested and connected with the enlarged diameter portion. The outer tube 4 is sleeved outside the inner tube 3, forming a second annular cavity 8 between the outer tube and the inner tube; the front end port of the outer tube 4 is located behind the enlarged diameter portion of the inner tube and forms a liquid replenishment port 41 between the inner tube and the inner tube.
第一Y形阀5套装在外管4的后部，前端与外管4的后端相连，第一Y形阀上设有用于与补液泵连接的补液接头51，该补液接头与第二环腔连通。The first Y-shaped valve 5 is set on the rear part of the outer pipe 4, and the front end is connected with the rear end of the outer pipe 4. The first Y-shaped valve is provided with a liquid replenishment joint 51 for connecting with the liquid replenishment pump, and the liquid replenishment joint is connected to the second annular cavity connected.
第二Y形阀6套装在叶轮组件上并串接在第一Y形阀后，前端与内管的后端相连，第二Y形阀上设有用于与抽栓泵连接的排栓接头61，该排栓接头与第一环腔连通。The second Y-shaped valve 6 is set on the impeller assembly and connected in series behind the first Y-shaped valve, the front end is connected to the rear end of the inner pipe, and the second Y-shaped valve is provided with a bolt discharge joint 61 for connecting with the bolt pump , the bolt-discharging joint communicates with the first annular cavity.
在第一Y形阀5后端与内管3之间设有用于防止补液渗漏的第一密封圈9；在第二Y形阀6后端与叶轮组件的传动轴12之间设有用于防止排出液渗漏的第二密封圈10。Between the rear end of the first Y-shaped valve 5 and the inner pipe 3, a first sealing ring 9 for preventing liquid replacement leakage is provided; between the rear end of the second Y-shaped valve 6 and the drive shaft 12 of the impeller assembly, a Second sealing ring 10 to prevent leakage of effluent.
本发明的工作原理可结合图7、图8说明如下：Working principle of the present invention can be described as follows in conjunction with Fig. 7, Fig. 8:
图7、图8中所示，15表示人体下肢深静脉，16表示深静脉血栓。为了取除深静脉血栓，将本发明的局部循环式血栓取除器插入人体下肢深静脉，使其头端达到深静脉血栓部位。将传动方轴11与电机相连，将补液接头51与补液泵相连，将排栓接头61与抽栓泵相连。然后启动电机、补液泵和抽栓泵，通过传动轴12、叶轮转轴13带动叶轮14转动，叶轮转动产生的相对负压把血栓吸向吸栓口21，血栓接触叶轮后被打成碎粒并由泄压口22排出至静脉局部。由补液泵送来的生理盐水则经补液接头51进入内管与外管之问的第二环腔8，从补液口4l注入静脉局部，少部分向右流入静脉未发生血栓的区段与正常血液融合，大部分向左流，与已经打碎的血栓碎粒融合，在相对负压的作用下一起从排栓口23经由内管与传动轴1l之间的第一环腔7，经排栓接头61排出体外。As shown in Fig. 7 and Fig. 8, 15 represents a deep vein of a lower limb of a human body, and 16 represents a deep vein thrombosis. In order to remove the deep vein thrombosis, the local circulation thrombus remover of the present invention is inserted into the deep vein of the lower limbs of the human body, so that its head reaches the deep vein thrombosis site. Connect the transmission square shaft 11 with the motor, connect the liquid infusion joint 51 with the liquid infusion pump, and connect the bolt discharge joint 61 with the bolt pump. Then start the motor, the liquid infusion pump and the plug pump, drive the impeller 14 to rotate through the drive shaft 12 and the impeller shaft 13, the relative negative pressure generated by the rotation of the impeller will suck the thrombus to the plug suction port 21, and the thrombus will be broken into pieces after contacting the impeller It is discharged to the local vein through the pressure relief port 22. Physiological saline from the infusion pump enters the second annular cavity 8 between the inner tube and the outer tube through the infusion connector 51, injects into the vein from the infusion port 41, and a small part flows to the right into the vein without thrombus and normal The blood merges, most of it flows to the left, and merges with the crushed thrombus fragments. Under the action of relative negative pressure, the blood is discharged together from the embolus discharge port 23 through the first annular cavity 7 between the inner tube and the transmission shaft 11. The plug joint 61 is excreted from the body.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310534616.2ACN104586469B (en) | 2013-11-01 | 2013-11-01 | Partial Circulation Thrombectomy Device |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310534616.2ACN104586469B (en) | 2013-11-01 | 2013-11-01 | Partial Circulation Thrombectomy Device |
| Publication Number | Publication Date |
|---|---|
| CN104586469A CN104586469A (en) | 2015-05-06 |
| CN104586469Btrue CN104586469B (en) | 2016-09-14 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201310534616.2AExpired - Fee RelatedCN104586469B (en) | 2013-11-01 | 2013-11-01 | Partial Circulation Thrombectomy Device |
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| CN (1) | CN104586469B (en) |
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| CF01 | Termination of patent right due to non-payment of annual fee | Granted publication date:20160914 Termination date:20191101 |