技术领域technical field
本发明涉及用于动脉血栓移除的微型乳化器，并且具体地，尽管并非唯一地，指通过具有挠性传输线的小型化压电换能器的血栓的超声消溶(ablation)，以及指生物物质的乳化，例如血栓的超声乳化(phacoemulsification)。The present invention relates to microemulsifiers for arterial thrombus removal, and in particular, though not exclusively, to the ultrasonic ablation of thrombi by miniaturized piezoelectric transducers with flexible transmission lines, and to biological matter emulsification, such as phacoemulsification (phacoemulsification) of thrombus.
背景技术Background technique
血栓是在血管中形成并停留在血管中的血凝块。这能在该区域中造成损伤、破坏(梗塞)，或者甚至组织的死亡(坏死)。血栓外科手术是常见的做法。已发展出用于血栓移除的许多不同的手术工具。这些工具包括通过机械力、血栓溶解剂(Thrombolytic agent)的使用以及超声能移除血栓的工具。然而，这些技术存在众多缺点，包含，但不限于低效率和对血管壁的损伤。A thrombus is a blood clot that forms and stays in a blood vessel. This can cause damage, destruction (infarction), or even death of tissue (necrosis) in the area. Thrombosurgery is common practice. Many different surgical tools have been developed for thrombus removal. These tools include those that remove blood clots through mechanical force, the use of thrombolytic agents, and ultrasound energy. However, these techniques suffer from numerous disadvantages including, but not limited to, low efficiency and damage to the vessel wall.
已开发了用于血栓溶解消溶的压电装置。促动器具有为促动器供应产生超声能所要求的电能的外部发电机。锆钛酸铅(“PZT”)晶体的换能器将电能转化为高功率超声波。连接在换能器近端的超声导管将超声波传输到在其远端的靶血栓。通过超声的血栓的消溶是通过由超声波造成的在血凝块中的空化(cavitation)作用。Piezoelectric devices have been developed for thrombolytic ablation. The actuator has an external generator that supplies the actuator with the electrical energy required to generate the ultrasonic energy. A transducer of lead zirconate titanate ("PZT") crystal converts electrical energy into high power ultrasonic waves. An ultrasound catheter attached proximal to the transducer transmits ultrasound to the target thrombus at its distal end. Ablation of thrombus by ultrasound is by cavitation in the clot caused by ultrasound.
超声组织消溶呈现组织选择性。生物组织对超声破坏的敏感性与它们的弹性回缩力成反比，弹性回缩力由它们的胶原蛋白和弹性蛋白含量表示。尽管血栓本身较不具有弹性元素，它们对超声消溶高度敏感。相反地，富有胶原蛋白和弹力蛋白的顺应性(compliant)基质的正常动脉壁则相对地对超声消溶不敏感。由于空化作用是生物选择性的，主动脉壁对空化作用有抵抗作用，仅有血栓被上述的促动器消溶。Ultrasonic tissue ablation exhibits tissue selectivity. The sensitivity of biological tissues to ultrasonic damage is inversely proportional to their elastic recoil, as indicated by their collagen and elastin content. Although thrombi have less elastic elements themselves, they are highly sensitive to sonication. In contrast, normal arterial walls with a compliant matrix rich in collagen and elastin are relatively insensitive to sonication. Since cavitation is bioselective, the aortic wall is resistant to cavitation and only the thrombus is ablated by the aforementioned actuator.
超声导管用于治疗人类血管的一个例子是将含有溶解化合物的溶液直接递送到闭塞位点，以移除或减小闭塞。此外，超声能由超声组件生成，并被用于增强溶解化合物的治疗作用。由于仅有导管被插入到血管中，并且换能器在体外，需要的输入功率将是高的，以提供足够的超声能到用于血栓溶解的导管。同样，由于导管的长的长度，沿导管的能量损失将是高的。这意味着效率将因能量损失而降低。An example of an ultrasound catheter being used to treat a human blood vessel is to deliver a solution containing a dissolving compound directly to the site of an occlusion to remove or reduce the occlusion. In addition, ultrasonic energy is generated by the ultrasonic components and used to enhance the therapeutic effect of dissolved compounds. Since only the catheter is inserted into the blood vessel, and the transducer is outside the body, the required input power will be high to provide sufficient ultrasound energy to the catheter for thrombolysis. Also, due to the long length of the conduit, energy losses along the conduit will be high. This means that efficiency will decrease due to energy loss.
另一个例子使用经颅超声血栓溶解系统，该系统使用与血栓溶解剂组合的超声能来辅助溶解颅内血栓以及来增强血栓溶解剂的效力。然而，系统的大尺寸限制了其实际应用。Another example uses a transcranial ultrasonic thrombolytic system that uses ultrasound energy in combination with a thrombolytic agent to assist in dissolving intracranial thrombi and to enhance the efficacy of the thrombolytic agent. However, the large size of the system limits its practical application.
超声医学装置的再一例子被用于治疗深静脉血栓，通过使用沿超声探针的纵轴具有多个横向波节(node)和波腹(anti-nodes)的超声能，以产生空化作用，来消溶血栓和治疗深静脉血栓。横向超声振动可能损伤周围的细胞，而不仅仅是血栓。同样，由于仅有导管被插入到体内，其被定位到血栓的能力较差。Yet another example of an ultrasonic medical device is used to treat deep vein thrombosis by using ultrasonic energy with multiple transverse nodes and anti-nodes along the longitudinal axis of the ultrasonic probe to create cavitation , to eliminate thrombus and treat deep vein thrombosis. Transverse ultrasonic vibrations may damage surrounding cells, not just the thrombus. Also, since only the catheter is inserted into the body, its ability to localize the thrombus is poor.
现有技术并未提供合适的要被插入到体内的装置来消溶、乳化并且移除血栓。现有技术并未提供如同在人类的应用中所要求的较好地定位到血栓位点以具有较高的精确度的解决方案。现有技术使用高输入功率来生成低频超声能。它们均在转化过程中遭受大的能量损失。由此，仍然存在着对小尺寸的设备的需要，以便能够被插入到体内并且能够消溶、乳化并且移除血栓。这优选地是以更局部化的方式。The prior art does not provide suitable devices to be inserted into the body to dissolve, emulsify and remove the thrombus. The prior art does not provide a solution to better localize the thrombus site with higher precision as required in human applications. Prior art uses high input power to generate low frequency ultrasonic energy. They all suffer from large energy losses during the conversion process. Thus, there remains a need for a device of small size that can be inserted into the body and that can ablate, emulsify and remove thrombus. This is preferably in a more localized fashion.
发明内容Contents of the invention
根据第一示例性方面，提供一种微型乳化器，包括叠堆的压电材料，在所述叠堆的压电材料近端的角状部，以及可接收于所述角状部中用于超声波的传输的传输线，所述超声波能够由所述叠堆的压电材料产生。所述超声波能够在平行于所述叠堆的压电材料和所述角状部的纵轴的方向产生。According to a first exemplary aspect, there is provided a microemulsifier comprising a stack of piezoelectric material, a horn at a proximal end of the stack of piezoelectric material, and receivable in the horn for A transmission line for the transmission of ultrasonic waves capable of being generated by the stack of piezoelectric materials. The ultrasonic waves can be generated in a direction parallel to the longitudinal axes of the stack of piezoelectric materials and the horn.
根据另一示例性方面，提供一种微型乳化器，包括叠堆的压电材料，在所述叠堆的压电材料近端的角状部，以及可接收于所述角状部中用于超声波的传输的传输线，所述超声波能够由所述叠堆的压电材料产生。所述传输线包括可接收于所述角状部中的第一端和远离所述第一端的第二端，所述第二端具有在其上的球状部。According to another exemplary aspect, there is provided a microemulsifier comprising a stack of piezoelectric material, a horn at a proximal end of the stack of piezoelectric material, and receivable in the horn for A transmission line for the transmission of ultrasonic waves capable of being generated by the stack of piezoelectric materials. The transmission line includes a first end receivable in the horn and a second end remote from the first end, the second end having a bulb thereon.
针对第一示例性方面，所述传输线可以包括可接收于所述角状部中的第一端和远离所述第一端的第二端，所述第二端具有在其上的球状部。For the first exemplary aspect, the transmission line may include a first end receivable in the horn and a second end remote from the first end, the second end having a bulb thereon.
根据再一示例性方面，提供一种用于微型乳化器的传输线，所述传输线包括被构造为可被接收于所述微型乳化器的角状部中的第一端，以及远离所述第一端的第二端，所述第二端具有在其上的球状部。According to yet another exemplary aspect, there is provided a transmission line for a microemulsifier, the transmission line including a first end configured to be received in a horn of the microemulsifier, and a The second end of the end has a bulbous portion thereon.
针对全部三个示例性方面，所述球状部为与所述第二端成为一体和固定到所述第二端中的至少一种。所述球状部可以具有光滑的外表面。所述外表面可以是不规则形或球形。所述传输线可以是挠性的；并且可以是金属材料的。For all three exemplary aspects, the bulb is at least one of integral with and fixed to the second end. The bulb may have a smooth outer surface. The outer surface may be irregular or spherical. The transmission line may be flexible; and may be of metallic material.
针对前两个示例性方面，所述超声波可以是能够在平行于所述叠堆的压电材料和所述角状部的纵轴的方向产生。所述叠堆的压电材料可以包括多个压电元件。每个压电元件可以包括有中空芯的圆柱体。每个压电元件可以在平行于所述叠堆的压电材料和所述角状部的纵轴的方向周期性地压缩和扩张。所述角状部可以是中空管，并且可以在其中接收所述用于纵向超声波的传输的传输线。所述传输线可以以压紧配合或卡扣配合的方式被接收。所述传输线与所述角状部的接合可以使用固定剂和/或密封剂。可替换地，所述传输线可以与所述角状部为一体。Regarding the first two exemplary aspects, the ultrasonic waves may be capable of being generated in a direction parallel to the longitudinal axes of the stack of piezoelectric materials and the horn. The stack of piezoelectric materials may include a plurality of piezoelectric elements. Each piezoelectric element may comprise a cylinder with a hollow core. Each piezoelectric element may periodically compress and expand in a direction parallel to the longitudinal axis of the stack of piezoelectric material and the horn. The horn may be a hollow tube, and the transmission line for transmission of the longitudinal ultrasonic waves may be received therein. The transmission line may be received with a press fit or a snap fit. The bonding of the transmission line to the horn may use a fixative and/or a sealant. Alternatively, the transmission line may be integral with the horn.
所述微型乳化器可以能够被容适于主要血管中，并且所述传输线可以能够被定位于小血管中用于在所述小血管中血栓的消溶。The microemulsifier may be capable of being accommodated in major blood vessels, and the delivery wire may be capable of being positioned in small blood vessels for ablation of thrombus in the small blood vessels.
根据最后的示例性方面，提供一种在第一血管中消溶血栓的方法，所述方法包括：沿能够容适所述微型乳化器的大血管传递如上所述的微型乳化器直到所述传输线接触所述大血管中的所述血栓，或者进入较小血管并且接触所述较小血管中的血栓，促动所述微型乳化器以在所述球状部生成纵向定向的超声能来消溶所述血栓。所述血栓的所述消溶可以是通过空化和机械破碎的至少一种。消溶可以包含乳化、重组和血栓溶解。According to a final exemplary aspect, there is provided a method of dissolving a thrombus in a first blood vessel, the method comprising: passing a microemulsifier as described above along a large vessel capable of accommodating the microemulsifier until the delivery line contacts The thrombus in the large vessel, or entering and contacting a thrombus in a smaller vessel, actuates the microemulsifier to generate longitudinally directed ultrasonic energy at the bulb to dissolve the thrombus . The ablation of the thrombus may be by at least one of cavitation and mechanical fragmentation. Ablation can include emulsification, reconstitution and thrombolysis.
附图说明Description of drawings
为了使本发明可以被全面地理解并容易地实际执行，现在应通过非限定性实施例的方式来描述，所述非限定性实施例仅为示例性实施方案，参照附图进行描述。In order that the invention may be fully understood and readily carried out in practice, it shall now be described by way of non-limiting examples, which are merely exemplary embodiments, described with reference to the accompanying drawings.
附图中：图1是微型乳化器的示例性实施方案的示意图；In the drawings: Figure 1 is a schematic diagram of an exemplary embodiment of a microemulsifier;
图2是图1的示例性实施方案的换能器的纵向垂直横截面视图；Figure 2 is a longitudinal vertical cross-sectional view of the transducer of the exemplary embodiment of Figure 1;
图3是图1和2的示例性实施方案的传输线的示意图；Figure 3 is a schematic diagram of the transmission line of the exemplary embodiment of Figures 1 and 2;
图4是图示用于图1和2的示例性实施方案的压电材料的收缩与扩张的示意图；以及4 is a schematic diagram illustrating the contraction and expansion of the piezoelectric material used in the exemplary embodiment of FIGS. 1 and 2; and
图5是由图1到4的示例性实施方案的操作产生的纵向波形的图示。5 is a graphical representation of longitudinal waveforms produced by operation of the exemplary embodiment of FIGS. 1-4.
具体实施方式Detailed ways
图1到3中示出的是包括换能器20和传输线40的微型乳化器10。Shown in FIGS. 1 to 3 is a microemulsifier 10 comprising a transducer 20 and a transfer line 40 .
换能器20将电能转化为大功率超声能，并且包括一对用于供应电能到换能器20的电引线21。可替换地，可以在换能器20中提供内置式或可移除的电池。再可替换地，射频波可以被用于经由换能器20中的内置式天线(未示出)来供应能量。如所示出的，引线21在换能器20的远端27被连接到换能器20的主体26。The transducer 20 converts electrical energy into high-power ultrasonic energy, and includes a pair of electrical leads 21 for supplying electrical energy to the transducer 20 . Alternatively, a built-in or removable battery may be provided in the transducer 20 . Alternatively yet, radio frequency waves may be used to supply energy via a built-in antenna (not shown) in transducer 20 . As shown, the leads 21 are connected to the body 26 of the transducer 20 at the distal end 27 of the transducer 20 .
换能器20的主体26还包括促动线圈22和叠堆23的压电材料28。叠堆23的压电材料28的每一个可以是锆钛酸铅(“PZT”)晶体。如图4中示出的，叠堆23的压电材料28的每一个优选地是有中空芯29的圆柱体。每个压电材料28在换能器20的中心纵轴30的方向收缩和扩张。通过具有叠堆23的压电材料28，促进了多层放大，从而压电叠堆23起放大器的作用。尽管描述并图示了叠堆23，也可以使用单个环28或者管(长的环)。这在微型乳化器10要被进一步小型化时可以有帮助。The body 26 of the transducer 20 also includes a piezoelectric material 28 that actuates the coil 22 and the stack 23 . Each of the piezoelectric materials 28 of the stack 23 may be a lead zirconate titanate ("PZT") crystal. As shown in FIG. 4 , each of the piezoelectric materials 28 of the stack 23 is preferably a cylinder with a hollow core 29 . Each piezoelectric material 28 contracts and expands in the direction of the central longitudinal axis 30 of the transducer 20 . Multilayer amplification is facilitated by having a piezoelectric material 28 of the stack 23 so that the piezoelectric stack 23 acts as an amplifier. Although a stack 23 is described and illustrated, a single ring 28 or tube (long ring) could also be used. This can be helpful when the microemulsifier 10 is to be further miniaturized.
压电叠堆23的直径可以是，例如5mm，并且长度可以是，例如8mm。以此方式，微型乳化器10能够被放在主要血管内。The piezoelectric stack 23 may have a diameter of, for example, 5 mm and a length of, for example, 8 mm. In this way, microemulsifier 10 can be placed within a major blood vessel.
在其近端31，换能器20的主体26具有已知形式的角状部24和诸如中空管的构造，如所示出的。角状部24传输并放大超声能到传输线40，并且借助于角状部基座25而被安装到主体26。角状部24是中空管并且用于在其中接收传输线40。角状部24的直径可以是，例如1.5mm，并且其长度可以是，例如在20到30mm的范围内。At its proximal end 31, the body 26 of the transducer 20 has horns 24 of known form and configuration such as a hollow tube, as shown. Horn 24 transmits and amplifies ultrasonic energy to transmission line 40 and is mounted to body 26 by means of horn base 25 . Horn 24 is a hollow tube and is adapted to receive transmission line 40 therein. The diameter of the horn 24 may be, for example, 1.5 mm, and its length may be, for example, in the range of 20 to 30 mm.
角状部24可以是任何合适的材料，例如7075铝材料。铝具有低密度，这有助于由换能器20产生的超声波的放大。这还意味着压电叠堆23的质量比角状部24的质量相对地更大。Horns 24 may be any suitable material, such as 7075 aluminum. Aluminum has a low density, which contributes to the amplification of the ultrasonic waves generated by the transducer 20 . This also means that the piezoelectric stack 23 has a relatively greater mass than the horn 24 .
如果压电叠堆23具有质量m1，并且将生成速度v1，并且角状部具有质量m2，并且将生成速度v2，则由于能量的转化，If the piezoelectric stack 23 has a mass m1 and will generate a velocity v1 , and the horn has a mass m2 and will generate a velocity v2 , then due to the transformation of energy,
m1v1＝m2v2m1 v1 = m2 v2
由于m1大于m2，因此v2将大于v1。这促进了放大效果。由于由压电叠堆23生成的振幅不大(由其尺寸和物理性质造成的)，角状部24将充当由压电叠堆23产生的超声波的放大器。Since m1 is greater than m2 , v2 will be greater than v1 . This facilitates the magnification effect. Since the amplitude of the vibration generated by the piezoelectric stack 23 is not large (due to its size and physical properties), the horn 24 will act as an amplifier for the ultrasonic waves generated by the piezoelectric stack 23 .
传输线40具有用于安装在角状部24内的第一端41和在其上具有球状部分43的第二端42。传输线40传输超声能至在第二端42的靶血栓。传输线40具有集中在球状部分43的超声波。The transmission line 40 has a first end 41 for fitting within the horn 24 and a second end 42 having a bulbous portion 43 thereon. Transmission line 40 transmits ultrasonic energy to a target thrombus at second end 42 . The transmission line 40 has ultrasonic waves concentrated on the spherical portion 43 .
传输线40被连接在角状部24的近端，并且可以有在0.3到0.7mm范围内、优选地0.5mm的直径。传输线40的长度可以在10到40cm范围内，优选地15cm。传输线40的长度越短，能量损失越少，并且效率越好。传输线40的长度通过由换能器20生成的频率的波长确定(n*1/2λ，其中n是整数)。A transmission wire 40 is connected at the proximal end of horn 24 and may have a diameter in the range of 0.3 to 0.7 mm, preferably 0.5 mm. The length of the transmission line 40 may be in the range of 10 to 40 cm, preferably 15 cm. The shorter the length of the transmission line 40, the less energy is lost and the better the efficiency. The length of the transmission line 40 is determined by the wavelength of the frequency generated by the transducer 20 (n*1/2λ, where n is an integer).
传输线40的第二端42具有球状部43，该球状部43优选地具有光滑的形状并且可以大致上为球状。其可以与传输线40为一体，或者可以被牢固地地附接到传输线40。该球状部43可以是，例如聚合物(如环氧树脂)的，并且可以具有在1.0到2.0mm范围内、优选地1.5mm的直径。这使得传输线能够从换能器20延伸到小血管(例如冠状动脉)中。如此，换能器20可以保留在更大直径并且能够容适它的血管中，并且传输线40可以延伸到较小直径的血管中用于血栓的超声乳化。The second end 42 of the transmission line 40 has a bulbous portion 43 which preferably has a smooth shape and may be substantially spherical. It may be integral with the transmission line 40 or may be firmly attached to the transmission line 40 . The bulb 43 may be, for example, of a polymer, such as epoxy, and may have a diameter in the range of 1.0 to 2.0 mm, preferably 1.5 mm. This enables the transmission line to extend from the transducer 20 into small blood vessels such as coronary arteries. In this way, the transducer 20 can remain in the larger diameter vessel that can accommodate it, and the delivery line 40 can be extended into the smaller diameter vessel for phacoemulsification of the thrombus.
球状部43是微型乳化器10的接触血栓的部分。均匀且光滑的平面44是优选的。图示的球形状可以增加与血栓的接触面积。光滑表面44有助于预防在插入和/或操作期间对血管壁的损伤。表面44可以是非均匀的，以增加表面44的摩擦，以增强血栓的超声乳化。传输线优选地是挠性的，从而其能够沿着血管的路径以达到血栓的位点。The spherical part 43 is a part of the microemulsifier 10 that contacts the thrombus. A uniform and smooth flat surface 44 is preferred. The illustrated spherical shape increases the contact area with the thrombus. Smooth surface 44 helps prevent damage to the vessel wall during insertion and/or manipulation. The surface 44 may be non-uniform to increase the friction of the surface 44 to enhance phacoemulsification of the thrombus. The delivery wire is preferably flexible so that it can follow the path of the blood vessel to reach the site of the thrombus.
传输线40优选地是具有适合于超声波的传输的结晶结构的材料。如此，该传输线40优选为金属，更优选为硬金属。该传输线40还优选为挠性的。由于超声能在固体金属中或通过固体金属传输得最好，传输线40优选为，例如不锈钢或钛。由于微型乳化器10被插入到体内，材料必须适合于该目的。钛、Ti-6Al-4V(品级5)以优异的生物相容性并且以1E+7循环的高疲劳强度(Kt＝3.3)被使用。钛、Ti-6Al-4V(品级5)还具有高的挠性，以使其在被插入到血管中时能弯曲并改变形状。The transmission line 40 is preferably a material having a crystalline structure suitable for the transmission of ultrasonic waves. As such, the transmission line 40 is preferably a metal, more preferably a hard metal. The transmission line 40 is also preferably flexible. Since ultrasonic energy is best transmitted in or through solid metal, transmission line 40 is preferably, for example, stainless steel or titanium. Since the microemulsifier 10 is inserted into the body, the material must be suitable for this purpose. Titanium, Ti-6Al-4V (grade 5) was used with excellent biocompatibility and high fatigue strength (Kt =3.3) with 1E+7 cycles. Titanium, Ti-6Al-4V (grade 5), is also highly flexible so that it can bend and change shape when inserted into a blood vessel.
传输线40与角状部24的连接可以通过传输线40以压紧配合或卡扣配合的方式插入到角状部24中和/或可以使用固定和/或密封剂(例如环氧树脂、焊接，或诸如此类)。连接应是这样的，以最小化超声能在从角状部24到传输线40的传输中的损失。传输线40和角状部24之间良好的密封将在这方面有帮助。可替换地，传输线40可以与角状部24为一体。The connection of the transmission line 40 to the horn 24 can be inserted into the horn 24 through the transmission line 40 in a press-fit or snap-fit manner and/or a fixing and/or sealant (e.g., epoxy, solder, or and so on). The connection should be such as to minimize the loss of ultrasonic energy in transmission from the horn 24 to the transmission line 40 . A good seal between the transmission line 40 and the horn 24 will help in this regard. Alternatively, the transmission line 40 may be integral with the horn 24 .
叠堆23的压电元件28的圆柱体本质诱导压电元件28的贯序性收缩和扩张，以产生纵向定向的超声波，如图5中示出的。超声波可以具有在例如20到100KHz范围内、优选地60KHz的频率。The cylindrical nature of the piezoelectric elements 28 of the stack 23 induces sequential contraction and expansion of the piezoelectric elements 28 to generate longitudinally oriented ultrasonic waves, as shown in FIG. 5 . Ultrasonic waves may have a frequency in the range of eg 20 to 100 KHz, preferably 60 KHz.
通过微型乳化器10对血栓的消溶中涉及有两种协同机制的组合。第一种机制是空化作用。声学周期的负相期间，压力降低到血栓的蒸汽压以下。如此，所施加的高超声能可以造成血栓中微泡或空腔的形成。局部冲击波可以通过腔的快速扩张和坍塌而生成。微泡或空腔的相对剧烈内爆可以导致组织的破坏。空化在超声的消溶作用中的角色是通过以下发现被证实的，即组织消溶仅在空化阈以上的功率时观察到。A combination of two synergistic mechanisms is involved in the ablation of thrombus by microemulsifier 10 . The first mechanism is cavitation. During the negative phase of the acoustic cycle, the pressure drops below the vapor pressure of the thrombus. As such, the applied hypersonic energy can cause the formation of microbubbles or cavities in the thrombus. Localized shock waves can be generated by rapid expansion and collapse of the cavity. Relatively violent implosion of microbubbles or cavities can lead to tissue destruction. The role of cavitation in the ablation of ultrasound is confirmed by the finding that tissue ablation is only observed at powers above the cavitation threshold.
靶血栓的机械破碎是第二机制。这是由传输线40的球状部44的因超声波而产生的高频率、低振幅的纵向位移造成的。然而，传输线40的额外的横向运动，或者额外的空化作用，也可能同时发生。Mechanical disruption of the target thrombus is the second mechanism. This is caused by the high frequency, low amplitude longitudinal displacement of the bulb 44 of the transmission line 40 due to the ultrasound. However, additional lateral movement of the transmission line 40, or additional cavitation, may also occur simultaneously.
由于血栓似乎对超声破裂更敏感，这暗示了空化是血栓消溶的主要机理。空化导致纤维聚合物的解聚，由此造成血栓破碎。Since thrombi appear to be more sensitive to ultrasound disruption, this suggests that cavitation is the primary mechanism of thrombus ablation. Cavitation leads to depolymerization of the fibrous polymers, thereby causing fragmentation of the thrombus.
整个微型乳化器10均能被插入到血管中，而不是如现有技术的仅导管或传输线。这增加了效率。传输线40长度、强度和挠性，与球状部44一起，使得微型乳化器能够沿能容适其的较大的血管被传递，直到传输线接触较大血管中的血栓，或者进入较小血管并且接触较小血管中的血栓。超声波的纵向本质而不是横向声波能够以对小血管的壁的最小损伤风险消溶血栓。这可以有较低的输入功率和较高的效率。The entire microemulsifier 10 can be inserted into a blood vessel, rather than just a catheter or delivery wire as in the prior art. This increases efficiency. The length, strength and flexibility of the delivery line 40, together with the bulb 44, enables the microemulsifier to be delivered along a larger vessel that can accommodate it until the delivery line contacts a thrombus in a larger vessel, or enters a smaller vessel and contacts Blood clots in smaller blood vessels. The longitudinal nature of ultrasound rather than transverse sound waves enables thrombus dissolution with minimal risk of damage to the walls of small blood vessels. This allows for lower input power and higher efficiency.
微型乳化器10可以被放置在标准真空导管的尖端，允许朝向血栓位点的光滑递送。在血栓附近，微型乳化器10将被促动，在球状部44生成将消溶血栓的纵向定向的超声能。装置局部地生成超声能，并且因此在人体应用中有较高的精确度。这些将在本质上简化程序并且降低副作用。The microemulsifier 10 can be placed on the tip of a standard vacuum catheter, allowing smooth delivery towards the thrombus site. In the vicinity of a thrombus, the microemulsifier 10 will be actuated, generating longitudinally directed ultrasonic energy at the bulb 44 that will dissolve the thrombus. The device generates ultrasonic energy locally, and therefore has a higher degree of precision in human applications. These would substantially simplify the procedure and reduce side effects.
血栓的消溶被认为包含乳化、解破碎(defragmentation)、血栓溶解，等等。其可以通过两种不同的行为发生：The ablation of thrombus is considered to include emulsification, defragmentation, thrombus lysis, and the like. It can happen through two different behaviors:
(a)机械冲击。这里球状部44的震动将粉碎血栓。该作用中，即使没有波传播，血栓也能被破坏。为此原因，传输线40不应有大的长度。(a) Mechanical shock. The vibration of the bulb 44 here will break up the thrombus. In this action, the thrombus can be destroyed even without wave propagation. For this reason, the transmission line 40 should not have a large length.
(b)空化：这里超声能作为通过消溶、乳化、解破碎、血栓溶解等等破坏血栓的压力和/或应力波而在血栓中传播。(b) Cavitation: Here ultrasound energy is propagated in the thrombus as pressure and/or stress waves that disrupt the thrombus by ablation, emulsification, disintegration, thrombus dissolution, and the like.
微型乳化器10可以被用于，例如：The microemulsifier 10 can be used, for example:
·主动脉及其分支动脉中凝块的消散(lysis)；Dissipation of clots in the aorta and its branch arteries;
·冠状动脉中凝块的消散；Dissipation of clots in coronary arteries;
·静脉系统中凝块的消散；Dissipation of clots in the venous system;
·心肌内血流的改善；Improvement of blood flow in the myocardium;
·脑血管中凝块的消散：以及Dissipation of clots in cerebral vessels: and
·肺动脉中凝块的消散。• Dissipation of clots in pulmonary arteries.
尽管前文说明已描述了示例性实施方案，本领域技术人员将理解，在设计、构建和/或操作的细节中可以进行许多变化，而不偏离本发明。While the foregoing description has described exemplary embodiments, those skilled in the art will appreciate that numerous changes may be made in details of design, construction, and/or operation without departing from the invention.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/SG2008/000323WO2010027325A1 (en) | 2008-09-03 | 2008-09-03 | Micro-emulsifier for arterial thrombus removal |
| Publication Number | Publication Date |
|---|---|
| CN102238918A CN102238918A (en) | 2011-11-09 |
| CN102238918Btrue CN102238918B (en) | 2015-06-10 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200880131810.3AActiveCN102238918B (en) | 2008-09-03 | 2008-09-03 | Micro-emulsifier for arterial thrombus removal |
| Country | Link |
|---|---|
| CN (1) | CN102238918B (en) |
| AU (1) | AU2008361369B2 (en) |
| WO (1) | WO2010027325A1 (en) |
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