CN108187183A - A kind of built-in medical supersonic thromboembolism treatment instrument - Google Patents
A kind of built-in medical supersonic thromboembolism treatment instrument Download PDFInfo
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Abstract
本发明涉及医疗器械技术领域，一种内置式医用超声溶栓治疗仪，包括输液器、超声加载模块和超声留置波导管。超声加载模块中的超声换能器的前盖板和变幅杆均采用TC4钛合金材料制作而成，且中间打有直径Φ1mm的通孔。超声波留置波导管从有血栓的血管上游处顺着血流方向进入血管内。超声波留置波导管进入血管的部分两侧挖有若干小洞，从而在有栓子的血管里直接发射超声波，再配以溶栓剂消融血栓。经实验验证对血栓性疾病治疗具有无创性，操作简便、可重复使用。超声能量仅在内局部发挥作用，超声作用和药物均直达病灶，溶栓效果好，同时对周围组织损伤小，安全无副作用无不良反应等的巨大优点。
The invention relates to the technical field of medical instruments, and relates to a built-in medical ultrasonic thrombolysis treatment instrument, which includes an infusion set, an ultrasonic loading module and an ultrasonic indwelling waveguide. The front cover and the horn of the ultrasonic transducer in the ultrasonic loading module are made of TC4 titanium alloy material, and a through hole with a diameter of Φ1mm is punched in the middle. The ultrasonic indwelling waveguide enters the blood vessel from the upstream of the blood vessel with thrombus along the direction of blood flow. A number of small holes are dug on both sides of the part where the ultrasonic indwelling waveguide enters the blood vessel, so that ultrasonic waves can be directly emitted in the blood vessel with emboli, and then a thrombolytic agent is used to ablate the thrombus. It has been verified by experiments that it is non-invasive, easy to operate and reusable for the treatment of thrombotic diseases. Ultrasonic energy only exerts its effect on the inner part, and both the ultrasonic effect and the drug can directly reach the lesion, the effect of thrombolysis is good, and the damage to the surrounding tissue is small, and it is safe and has no side effects and no adverse reactions.
Description
技术领域technical field
本发明涉及医疗器械技术领域，具体是一种内置式医用超声溶栓治疗仪。The invention relates to the technical field of medical devices, in particular to a built-in medical ultrasonic thrombolysis treatment instrument.
背景技术Background technique
据可靠统计，我国约有3.3亿高血压患者，约占总人口的23.6％，比整个美国的人口还多，随着老龄化的加剧，比例还将进一步升高。在著名的雅尔塔会议上，罗斯福、斯大林和丘吉尔三大巨头重构了世界格局，然而，他们都分别死于心脑血管诱发的疾病。高血压就是血液在血管变窄遇到阻塞流动不畅时，对血管壁造成的侧压力高出正常值。高血压会选取心、脑、肾、眼等器官作为目标进行伤害，这就是“靶器官伤害”。简言之，凡是有动脉的地方都有可能被攻击。动脉粥样硬化斑块堆积到一定程度后，易受血流冲击，斑块破碎并与血管脱离，形成栓子，阻塞血管。如果发生在供应心脏血管的冠状动脉，就是冠心病；如果发生在脑部，就是脑血栓、脑中风。According to reliable statistics, there are about 330 million hypertensive patients in my country, accounting for about 23.6% of the total population, which is more than the entire population of the United States. With the aging population, the proportion will further increase. At the famous Yalta Conference, Roosevelt, Stalin and Churchill restructured the world pattern. However, they all died of cardiovascular and cerebrovascular-induced diseases. High blood pressure means that when the blood vessel narrows and encounters blockage and poor flow, the lateral pressure on the vessel wall is higher than the normal value. High blood pressure will select the heart, brain, kidney, eyes and other organs as targets for damage, which is "target organ damage". In short, wherever there are arteries there is a potential for attack. After the atherosclerotic plaque accumulates to a certain extent, it is vulnerable to the impact of blood flow, and the plaque breaks and separates from the blood vessel, forming an embolus and blocking the blood vessel. If it occurs in the coronary arteries that supply the heart, it is coronary heart disease; if it occurs in the brain, it is cerebral thrombosis or stroke.
此外，血液透析是肾功能衰竭患者主要的肾脏替代治疗方法之一，建立一条有效的血管通路是血液透析顺利进行的前提，有人将血管通路称之为尿毒症患者的生命线。良好的血管通路要求血流量达到200-300ml/min，而血栓常导致血流量不充分，进而引起透析不充分。因此，血栓是造成血管通路失败的主要原因。In addition, hemodialysis is one of the main renal replacement therapies for patients with renal failure. Establishing an effective vascular access is a prerequisite for the smooth progress of hemodialysis. Some people call vascular access the lifeline of uremia patients. Good vascular access requires a blood flow of 200-300ml/min, and thrombus often leads to insufficient blood flow, which in turn leads to insufficient dialysis. Thus, thrombus is a major cause of vascular access failure.
为此，消除血栓降低血压恢复血管通畅显得尤为重要。目前人工机械方法有球囊导管术和外科栓子切除术，但容易引起大出血等并发症，且手术风险大成本高，易反复发作。因此，临床上多使用活血化瘀的药物口服或点滴，如红花、丹参、当归、三七、水蛭、阿司匹林，或者组织纤溶激活酶原、尿激酶原(Pro-UK)等。但要么是只能预防，要么见效慢、溶栓时间长(往往一周时间)。For this reason, it is particularly important to eliminate thrombus, lower blood pressure, and restore vascular patency. At present, artificial mechanical methods include balloon catheterization and surgical embolectomy, but it is easy to cause complications such as massive bleeding, and the operation is risky and costly, and it is prone to repeated attacks. Therefore, clinically, drugs for promoting blood circulation and removing blood stasis are often used orally or intravenously, such as safflower, salvia, angelica, panax notoginseng, leech, aspirin, or tissue plasminogen and prourokinase (Pro-UK). But either it can only be prevented, or the effect is slow and the thrombolysis time is long (often a week).
于是市场上出现了新的超声溶栓术。主要利用超声波的机械振动、空化效应、微电流剪切力、微束流等能量，再配合溶栓剂的药理作用使血栓破裂溶解，栓塞血管再通。一种如高频低能的体外治疗性超声(ETUS)，例如“深圳市威尔德医疗电子有限公司”申请的专利号为“CN203898961U”的发明专利名称为“溶栓治疗探头”，就是将探头外置于阻塞血管处，探头发射的超声波穿过耦合剂和皮肤血管对栓子进行处理。功率较大时，患者皮肤会有明显灼热不适感；功率较小时溶栓效果不理想。还有一种如微泡声学造影剂促进体外超声消融血栓，例如“广州军区广州总医院”申请的专利号为“CN205548629U”的发明专利名称为“一种超声微泡空化溶栓系统”，就是一方面在体外发射超声波，另一方面在血管内注射超声波激励造影剂和溶栓剂。这是一种内外结合的方式，的确促进了血栓的消融，改进了效果，但患者仍然感到灼热不适，没有最大限度发挥超声波的性能优势。So a new ultrasonic thrombolysis appeared on the market. It mainly utilizes mechanical vibration of ultrasound, cavitation effect, micro-current shear force, micro-beam and other energy, combined with the pharmacological action of thrombolytic agent to rupture and dissolve thrombus and recanalize embolized blood vessels. A kind of extracorporeal therapeutic ultrasound (ETUS) such as high-frequency and low-energy, for example, the patent No. of "CN203898961U" applied by "Shenzhen Wild Medical Electronics Co., Ltd." Externally placed at the blocked blood vessel, the ultrasonic waves emitted by the probe pass through the coupling agent and skin blood vessels to treat the embolus. When the power is high, the patient's skin will have obvious burning discomfort; when the power is low, the thrombolytic effect is not ideal. There is also a microbubble acoustic contrast agent that promotes ultrasonic ablation of thrombus in vitro. For example, the patent number "CN205548629U" applied by "Guangzhou General Hospital of Guangzhou Military Region" is called "an ultrasonic microbubble cavitation thrombolysis system", which is On the one hand, ultrasonic waves are emitted outside the body, and on the other hand, ultrasonic waves are injected into blood vessels to stimulate contrast agents and thrombolytic agents. This is a combination of internal and external methods, which indeed promotes the ablation of the thrombus and improves the effect, but the patient still feels burning discomfort and does not maximize the performance advantages of ultrasound.
发明内容Contents of the invention
本发明的目的在于克服现有技术存在的不足，而提供一种内置式医用超声溶栓治疗仪。The purpose of the present invention is to overcome the deficiencies of the prior art, and provide a built-in medical ultrasonic thrombolysis treatment instrument.
本发明的目的是通过如下技术方案来完成的：这种内置式医用超声溶栓治疗仪，主要包括输液器、超声加载模块、超声留置波导管。输液泵内盛装有生理盐水或溶栓剂，输液泵连接排气室，排气室连接滴速传感器，滴速传感器连接加热器，加热器连接超声换能器，超声换能器被超声波发生器驱动，超声换能器通过喉箍连接超声波留置波导管，超声波留置波导管在有血栓的血管上游处顺着血流方向进入血管内，超声波留置波导管进入血管的部分两侧挖有若干小洞。The object of the present invention is accomplished through the following technical proposal: the built-in medical ultrasonic thrombolysis treatment instrument mainly includes an infusion set, an ultrasonic loading module, and an ultrasonic indwelling waveguide. The infusion pump is filled with physiological saline or thrombolytic agent, the infusion pump is connected to the exhaust chamber, the exhaust chamber is connected to the drip speed sensor, the drip speed sensor is connected to the heater, the heater is connected to the ultrasonic transducer, and the ultrasonic transducer is replaced by the ultrasonic generator. Driven, the ultrasonic transducer is connected to the ultrasonic indwelling waveguide through the throat hoop, and the ultrasonic indwelling waveguide enters the blood vessel upstream of the blood vessel with thrombus along the blood flow direction, and several small holes are dug on both sides of the part where the ultrasonic indwelling waveguide enters the blood vessel .
所述输液器包括输液泵、排气室、滴速传感器和加热器，如图1所示。The infusion set includes an infusion pump, an exhaust chamber, a drop rate sensor and a heater, as shown in FIG. 1 .
所述超声加载模块包括功率可调的驱动电源和超声换能器。The ultrasonic loading module includes an adjustable driving power supply and an ultrasonic transducer.
所述超声换能器包括超声振子和变幅杆。超声振子的前盖板和变幅杆均选用TC4钛合金，超声振子的压电陶瓷元件选用P4中功率发射材料，因为TC4钛合金的声阻抗Z4＝2.71X107pa*s/m与压电陶瓷P4的声阻抗Z5＝3X107pa*s/m接近，具体见下表1材料属性。The ultrasonic transducer includes an ultrasonic vibrator and a horn. Both the front cover and the horn of the ultrasonic vibrator are made of TC4 titanium alloy, and the piezoelectric ceramic element of the ultrasonic vibrator is made of P4 medium-power transmitting material, because the acoustic impedance Z 4 of TC4 titanium alloy = 2.71X10 7 pa*s/m and the pressure The acoustic impedance Z 5 =3X10 7 pa*s/m of electroceramic P4 is close to each other, see the material properties in Table 1 below for details.
表1材料属性Table 1 Material properties
所述超声换能器的方案一如图2所示，总长为58.5mm，裙边最大直径为Φ25mm，谐振频率为fs＝69.8kHz，性能测试曲线如图3所示，整个中间打直径Φ2mm的通孔。实验结果表明功率偏小，溶栓效果不理想。The first scheme of the ultrasonic transducer is shown in Figure 2, the total length is 58.5mm, the maximum diameter of the skirt is Φ25mm, the resonant frequency is fs=69.8kHz, the performance test curve is shown in Figure 3, and the whole middle is made with a diameter of Φ2mm through hole. The experimental results show that the power is too small and the thrombolytic effect is not ideal.
作为优化的方案二如图4所示，总长为178.5mm，卡盘最大直径为Φ25mm，仅在变幅杆上打倒“L”型长95mm、直径Φ1.5mm的孔。实验结果表明功率提高了，但溶栓效果仍然不理想。As the optimized scheme two, as shown in Figure 4, the total length is 178.5mm, the maximum diameter of the chuck is Φ25mm, and only the "L"-shaped hole with a length of 95mm and a diameter of Φ1.5mm is knocked down on the horn. The experimental results show that the power has been improved, but the thrombolytic effect is still not ideal.
作为优化的方案三如图5所示，总长为204mm，卡盘最大直径仍为Φ25mm，整个换能器中间打直径Φ1mm的通孔，便于药剂流过并加载超声能量，同时综合考虑了加工水平。采用有限元分析软件Ansys对上述结构进行仿真。首先建立有限元仿真模型，如图6所示，换能器振动时等效应力云图如图7所示，仿真的谐振频率为fs＝54kHz。实际性能测试曲线如图8所示，谐振频率为fs＝56kHz，属于材料参数设置的正常误差。实验结果表明该方案换能器输出功率强劲，振幅大效果优良，故最终选择方案三作为本发明的最终方案。As the optimized scheme three is shown in Figure 5, the total length is 204mm, the maximum diameter of the chuck is still Φ25mm, and a through hole with a diameter of Φ1mm is drilled in the middle of the entire transducer to facilitate the flow of medicine and load ultrasonic energy, while comprehensively considering the processing level . The above structure is simulated by finite element analysis software Ansys. Firstly, the finite element simulation model is established, as shown in Figure 6, and the cloud diagram of the equivalent stress when the transducer vibrates is shown in Figure 7, and the simulated resonant frequency is fs=54kHz. The actual performance test curve is shown in Figure 8, and the resonant frequency is fs=56kHz, which belongs to the normal error of material parameter setting. Experimental results show that the transducer output power of this scheme is strong, and the effect of large amplitude is excellent, so the final scheme three is selected as the final scheme of the present invention.
所述超声留置波导管选用聚氨酯材料。输液即为生理盐水添加溶栓剂，具体属性随添加不同的溶栓剂而略有差异，故现以海水参照模拟，约为Z1＝1.54X106pa*s/m。而血液的声阻抗Z3＝1.65X106pa*s/m，聚氨酯的声阻抗Z2＝1.57X106pa*s/m，三者几乎一致，且Z2恰为Z1和Z3之间。假定平面波在两种不同均匀介质面上垂直入射，则声波从药水穿过聚氨酯波导管入射血液的两次透射损失和TL(dB)为：The ultrasonic indwelling waveguide is made of polyurethane material. The infusion is normal saline with thrombolytic agent added, and the specific properties are slightly different with the addition of different thrombolytic agents, so it is now simulated with sea water as a reference, about Z 1 =1.54X10 6 pa*s/m. The acoustic impedance Z 3 of blood is 1.65X10 6 pa*s/m, the acoustic impedance Z 2 of polyurethane is 1.57X10 6 pa*s/m, the three are almost the same, and Z 2 is just between Z 1 and Z 3 . Assuming that the plane wave is incident vertically on two different homogeneous medium surfaces, the two transmission losses and TL (dB) of the sound wave entering the blood from the liquid medicine through the polyurethane waveguide are:
表1数据代入式1，透射损失和TL很小，几乎可以忽略不计。所以超声留置波导管选用聚氨酯材料。Substituting the data in Table 1 into Equation 1, the transmission loss and TL are very small, almost negligible. Therefore, the ultrasonic indwelling waveguide is made of polyurethane material.
为便于向血液辐射声波和溶栓剂，增强超声溶栓效果，超声波导管的两侧各挖洞开口，如图9所示，同一侧相邻两洞口间距为In order to radiate sound waves and thrombolytic agents to the blood and enhance the effect of ultrasonic thrombolysis, holes are dug on both sides of the ultrasonic catheter, as shown in Figure 9, and the distance between two adjacent holes on the same side is
且一侧的洞口位置恰在另一侧两洞口位置的中间，即为 And the position of the opening on one side is just in the middle of the positions of the two openings on the other side, which is
本发明的有益效果为：The beneficial effects of the present invention are:
1、输液泵具有半挤压功能和脉动补偿技术，使输液更均匀、误差小，可长时间保持管路弹性和流速精度。1. The infusion pump has a semi-squeeze function and pulsation compensation technology, which makes the infusion more uniform and has less error, and can maintain the elasticity of the pipeline and the accuracy of the flow rate for a long time.
2、加热器可将流过的液体加热至40-50℃且可调，具体调节可依据夏冬环境温度和患者个人感受而定。2. The heater can heat the flowing liquid to 40-50°C and is adjustable. The specific adjustment can be determined according to the ambient temperature in summer and winter and the personal feeling of the patient.
3、本发明对血栓性疾病治疗具有无创性，操作简便、可重复使用，以及超声能量仅在内局部发挥作用、超声作用和药物均直达病灶，溶栓效果好，治疗时间短，对周围组织损伤小，安全可靠等的巨大优点。3. The present invention is non-invasive in the treatment of thrombotic diseases, easy to operate, reusable, and the ultrasonic energy only plays a role in the inner part, and both the ultrasonic action and the drug can directly reach the lesion, the thrombolytic effect is good, the treatment time is short, and the surrounding tissue Small damage, safe and reliable and other great advantages.
附图说明Description of drawings
图1为本发明的超声溶栓治疗仪结构示意图。Fig. 1 is a schematic diagram of the structure of the ultrasonic thrombolytic therapy apparatus of the present invention.
图2为本发明的超声换能器方案一图。Fig. 2 is a diagram of the first scheme of the ultrasonic transducer of the present invention.
图3为本发明的超声换能器方案一的阻抗测试曲线图。Fig. 3 is an impedance test curve diagram of the ultrasonic transducer scheme 1 of the present invention.
图4为本发明的超声换能器方案二图。Fig. 4 is the second diagram of the ultrasonic transducer scheme of the present invention.
图5为本发明的超声换能器方案三图。Fig. 5 is the third diagram of the ultrasonic transducer scheme of the present invention.
图6为本发明的超声换能器方案三的仿真模型图。Fig. 6 is a simulation model diagram of the ultrasonic transducer scheme 3 of the present invention.
图7为本发明的超声换能器方案三的等效应力云图。Fig. 7 is an equivalent stress cloud diagram of the ultrasonic transducer scheme 3 of the present invention.
图8为本发明的超声换能器方案三的阻抗测试曲线图。FIG. 8 is a curve diagram of an impedance test of the third solution of the ultrasonic transducer of the present invention.
图9为本发明的超声留置波导管挖洞间距图。Fig. 9 is a diagram of the hole spacing of the ultrasonic indwelling waveguide of the present invention.
附图标记说明：输液泵1、生理盐水或溶栓剂2、排气室3、滴速传感器4、加热器5、超声换能器6、超声波发生器7、喉箍8、超声留置波导管9、血栓10、血管11、孔洞12、超声振子13、变幅杆14、前盖板15、通孔16。Explanation of reference signs: infusion pump 1, physiological saline or thrombolytic agent 2, exhaust chamber 3, drop rate sensor 4, heater 5, ultrasonic transducer 6, ultrasonic generator 7, throat clamp 8, ultrasonic indwelling waveguide 9. Thrombus 10, blood vessel 11, hole 12, ultrasonic vibrator 13, horn 14, front cover plate 15, through hole 16.
具体实施方式Detailed ways
下面将结合附图对本发明做详细的介绍：The present invention will be described in detail below in conjunction with accompanying drawing:
如附图所示，这种内置式医用超声溶栓治疗仪，主要包括输液泵1，输液泵1内盛装有生理盐水或溶栓剂2。输液泵1连接排气室3，排气室3连接滴速传感器4，滴速传感器4连接加热器5，加热器5连接超声换能器6，超声换能器6被超声波发生器7驱动。超声换能器6通过喉箍8连接超声波留置波导管9。喉箍8可确保超声换能器6和超声波留置波导管9在振动时不易脱落。超声波留置波导管9在有血栓10的血管11上游处顺着血流方向进入血管11内。超声波留置波导管9进入血管11的部分两侧挖有若干小洞12。As shown in the accompanying drawings, this built-in medical ultrasonic thrombolytic therapeutic apparatus mainly includes an infusion pump 1 containing physiological saline or a thrombolytic agent 2 . The infusion pump 1 is connected to the exhaust chamber 3 , the exhaust chamber 3 is connected to the drip speed sensor 4 , the drip speed sensor 4 is connected to the heater 5 , the heater 5 is connected to the ultrasonic transducer 6 , and the ultrasonic transducer 6 is driven by the ultrasonic generator 7 . The ultrasonic transducer 6 is connected to an ultrasonic indwelling waveguide 9 through a throat hoop 8 . The throat hoop 8 can ensure that the ultrasonic transducer 6 and the ultrasonic indwelling waveguide 9 are not easy to fall off when vibrating. The ultrasonic indwelling waveguide 9 enters the blood vessel 11 at the upstream of the blood vessel 11 with the thrombus 10 along the blood flow direction. Several small holes 12 are dug on both sides of the part where the ultrasonic indwelling waveguide 9 enters the blood vessel 11 .
在具体实施时，加热器5可将流过的液体加热至40-50℃且可调，具体调节可依据夏冬环境温度和患者个人感受而定。In practice, the heater 5 can heat the flowing liquid to 40-50°C and is adjustable, and the specific adjustment can be determined according to the ambient temperature in summer and winter and the personal feeling of the patient.
如图5所示，超声换能器6包括超声振子13和变幅杆14，超声振子13包括而不仅限于前盖板15，前盖板15和变幅杆14均采用TC4钛合金材料制作而成。超声振子13和变幅杆14中间打有直径Φ1mm的通孔16。超声换能器6的总长为204mm，谐振频率为fs＝56kHz。As shown in Figure 5, the ultrasonic transducer 6 includes an ultrasonic vibrator 13 and a horn 14, the ultrasonic vibrator 13 includes but not limited to a front cover 15, the front cover 15 and the horn 14 are made of TC4 titanium alloy material to make. A through hole 16 with a diameter of Φ1 mm is drilled between the ultrasonic vibrator 13 and the horn 14 . The total length of the ultrasonic transducer 6 is 204mm, and the resonance frequency is fs=56kHz.
如图9所示，超声波留置波导管9选用聚氨酯材料制作而成。超声波留置波导管9的两侧挖有若干小洞12，同一侧相邻两洞口间距26.8mm。且一侧的洞口位置恰在另一侧两洞口位置的中间，即异侧相邻两洞口间距为13.4mm。As shown in FIG. 9 , the ultrasonic indwelling waveguide 9 is made of polyurethane material. Several small holes 12 are dug on both sides of the ultrasonic indwelling waveguide 9, and the distance between two adjacent holes on the same side is 26.8 mm. And the position of the opening on one side is just in the middle of the positions of the two openings on the other side, that is, the distance between two adjacent openings on the opposite side is 13.4mm.
可以理解的是，对本领域技术人员来说，对本发明的技术方案及发明构思加以等同替换或改变都应属于本发明所附的权利要求的保护范围。It can be understood that, for those skilled in the art, equivalent replacements or changes to the technical solutions and inventive concept of the present invention shall fall within the protection scope of the appended claims of the present invention.
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| CN113974765A (en) * | 2021-10-22 | 2022-01-28 | 清华大学 | Intervention type thrombus removal device and thrombolysis promoting module |
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