Intravascular forward vibration wave type penetrating microcatheter

Abstract

The invention discloses an intravascular forward vibration wave type penetration micro-catheter which comprises a vibration wave micro-catheter, an ultrasonic transducer and a vibration driving system. When in use, the vibration wave microcatheter intervenes into a blood vessel of a human body, the front end of the vibration wave microcatheter reaches the front section of a blocked part in the blood vessel, the rear end of the vibration wave microcatheter is in driving connection with the ultrasonic transducer outside the blood vessel, and the ultrasonic transducer is subjected to motion control through the vibration driving system. The device has forward vibration control capability, and can provide directional vibration with specified frequency and power to destroy calcified tissues at a focus, so that the inner diameter of a blood vessel at the focus is safely and effectively enlarged; meanwhile, by means of the amplitude dynamic control method of the vibration antifriction effect, the viscous resistance of blood to the guide wire is reduced, surgical instruments intervening in the blood vessel can rapidly pass through a target focus along the guide wire, high-resistance components in local lesions are released or broken, the follow-up surgical instruments can pass through the guide wire in a barrier-free mode, and the surgical efficiency is greatly improved.

Description

Technical Field

[0001] The present invention relates to a microcatheter, in particular to an intravascular forward shock wave penetrating microcatheter, belonging to the technical field of medical devices. Background Art

[0002] Coronary intervention generally refers to percutaneous coronary intervention, which is a minimally invasive treatment method, mostly used for treating coronary heart disease, angina pectoris, myocardial infarction, etc. At present, coronary intervention is one of the most effective leading treatment options for patients with severe coronary heart disease. During the operation, it is necessary to deliver balloons, stents, etc. through one or more 0.014-inch guidewires to complete the operation. However, high-resistance lesions that balloons and the like cannot pass through are the main obstacles to coronary intervention.

[0003] In the prior art, there are the following several treatment methods for such lesions clinically:

[0004] 1) Replace the rotational atherectomy guidewire and initiate intracoronary rotational atherectomy. However, most commonly used coronary microcatheters for such lesions cannot pass through either, so the rotational atherectomy guidewire cannot be successfully replaced, resulting in the failure of the operation;

[0005] 2) Although initiating laser is an effective method, it requires the use of special devices (convalescent instruments), and is expensive, and has poor effects on severely calcified lesions;

[0006] 3) When re-operating, pass another guidewire through the lesion at a different location. Such operation and treatment are not only time-consuming, but also have a lower success rate. Once the guidewire passes through the lesion, clinically, it is necessary to efficiently and quickly implant the balloon and stent for dilation along this guidewire to quickly complete coronary intervention and reduce complications. However, the success rate of the existing such surgery is generally low, and the clinical effect is poor.

[0007] Therefore, the shock wave friction reduction effect in the human blood vessel is also beneficial to improving the working efficiency of the microcatheter intervention surgery, shortening the operation time, reducing the operation difficulty of doctors, and at the same time reducing clinical complications. Therefore, it is necessary to propose an intravascular forward shock wave penetrating microcatheter based on the shock wave friction reduction effect to improve the success rate of the surgery. Summary of the Invention

[0008] The purpose of the present invention is to solve the above problems, and provide an intravascular forward shock wave penetrating microcatheter to solve the problems of generally low success rate of coronary intervention and poor clinical effect.

[0009] The technical solution of the present invention is: An intravascular forward shock wave penetrating microcatheter, comprising a shock wave microcatheter, an ultrasonic transducer and a vibration driving system. The characteristics are: The shock wave microcatheter is inserted into the blood vessel of the human body, the front end of the shock wave microcatheter reaches the front section of the blockage inside the blood vessel, and the rear end of the shock wave microcatheter is drivingly connected to the ultrasonic transducer outside the blood vessel; The ultrasonic transducer includes a horn, a vibration transducer part and a piezoelectric linear actuator part connected in sequence. The vibration transducer part includes several annular piezoelectric ceramics. The size and dimensions of the horn can be selected with different structural dimensions according to the specific blockage situation after angiography. The ratio of the left end diameter to the right end diameter is between 0.2 and 0.8. Different diameter ratios correspond to different amplitudes at the left end, that is, different amplitudes at the catheter end. The purpose is to provide forward vibration suitable for destroying plaques, while the vibration is not too large, so as to avoid blood vessel damage. The piezoelectric linear actuator part includes a cylindrical piezoelectric ceramic, a multi-foot base body and a linear guide rail. The cylindrical piezoelectric ceramic is arranged on the upper part of the multi-foot base body. When a control signal with a 90° phase difference is applied to the cylindrical piezoelectric ceramic, the multi-foot base body can generate vibrations from the rear to the front in sequence. The line formed by the positions of the tips of the multi-foot base body at any moment forms a sine wave in the shape of a water wave. When the excitation signal is specified and controlled by the vibration driving system, this sine wave can move along the axis of the ultrasonic transducer, and the same-direction movement causes the ultrasonic transducer to drive the shock wave microcatheter to generate a precisely controllable linear movement in the blood vessel. The lower part of the multi-foot base body is fixedly arranged on the vibration transducer part, and the vibration transducer part is positioned on the linear guide rail through at least one fixing member; The ultrasonic transducer is electrically connected to the vibration driving system.

[0010] Further, in the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: First and second pressing blocks are respectively arranged at the left and right ends of the annular piezoelectric ceramic along its length direction, and there is an extended block body at the right end of the second pressing block for connecting to the linear guide rail.

[0011] Further, in the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: The lower part of the multi-foot base body is fixedly arranged on the extended block body of the second pressing block, and the extended block body of the second pressing block is positioned on the linear guide rail through at least one fixing member (such as a circlip) to obtain linear movement.

[0012] Further, in the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: The shock wave microcatheter is a single-layer flexible catheter structure, and a hydrophilic coating for reducing protein and bacteria adsorption is provided on the outer side wall of the shock wave microcatheter.

[0013] Furthermore, for the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: a guide wire for interventional treatment is provided at the front end of the shock wave microcatheter, and the guide wire reaches the front section of the occlusion inside the blood vessel and directly intervenes in the vascular stenosis area formed by calcification and fibrous tissue.

[0014] Still further, for the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: it further includes a catheter injection part for introducing surgical instruments into the blood vessel.

[0015] In addition, for the above-mentioned intravascular forward shock wave penetrating microcatheter, wherein: the vibration drive system includes a data acquisition module, a data transmission module, a data processing module, a main control module, and a vibration control module that are communicatively connected in sequence. The ultrasonic transducer is connected to the main control module and the vibration control module via a data transmission line, and a data acquisition module, a data transmission module, and a data processing module are communicatively provided between the ultrasonic transducer and the main control module. The shock wave microcatheter is connected to the vibration control module via the data transmission line. The main control module is further communicatively connected to an amplitude adjustment module and a frequency adjustment module, and is connected to the vibration control module for receiving vibration amplitude and frequency control data through the amplitude adjustment module and the frequency adjustment module.

[0016] Adopting the technical solution of the present invention, under external control, the shock wave microcatheter is moved to the front section of the blood vessel occlusion, and the guide wire is used to directly intervene in the vascular stenosis area formed by calcification and fibrous tissue. The ultrasonic transducer is effectively operated by the vibration drive system, and energy is transmitted to the shock wave microcatheter through the ultrasonic transducer to control the effective forward vibration of its front end, realizing the effective loosening of calcification and fibrous tissue, thereby breaking through the vascular stenosis area and completing the entire process of the entry and passage of the surgical instrument intervention system.

[0017] Compared with the prior art, after adopting the technical solution of the present invention, the shock wave microcatheter has the ability of forward vibration control, can provide directional vibration with specified frequency and power to destroy the calcified tissue at the lesion, thereby expanding the inner diameter of the blood vessel at the lesion, which is beneficial to improving the success rate of surgical implantation; at the same time, through the amplitude dynamic control method of the vibration friction reduction effect, the viscous resistance of blood to the guide wire is reduced, enabling the surgical instruments of the intervention system to quickly pass through the target lesion along the guide wire, and at the same time loosening and / or breaking the high-resistance components in the local lesion, which is beneficial to the unobstructed passage of subsequent surgical instruments. Description of the Drawings

[0018] Figure 1 It is a schematic structural diagram of an embodiment of the present invention;

[0019] Figure 2 Schematic structural diagram of part A of the present invention;

[0020] Figure 3 Schematic structural diagram of the ultrasonic transducer of the present invention;

[0021] Figure 4 Frame diagram of the vibration drive system of the present invention.

[0022] The meanings of the reference numerals in the figure are as follows: 1 - blood vessel, 2 - calcified and fibrous tissue, 3 - blood vessel stenosis area, 4 - shock wave microcatheter, 41 - guide wire, 5 - ultrasonic transducer, 51 - horn, 52 - first pressing block, 53 - annular piezoelectric ceramic, 54 - second pressing block, 55 - cylindrical piezoelectric ceramic, 56 - multi-legged base, 57 - fixing member, 58 - linear guide rail, 6 - vibration drive system, 61 - data acquisition module, 62 - data transmission module, 63 - data processing module, 64 - main control module, 65 - amplitude adjustment module, 66 - frequency adjustment module, 67 - vibration control module, 7 - catheter injection part. Specific embodiments

[0023] The technical solution of the present invention will be further elaborated below in conjunction with the accompanying drawings to make it easier to understand and master. The system component modules such as the data acquisition module 61, data transmission module 62, data processing module 63, and main control module 64 involved are all commonly known and used by those of ordinary skill in the art, and there are no special requirements for them in this case.

[0024] As Figure 1 and Figure 2 shown, a forward shock wave type penetrating microcatheter in blood vessels of this embodiment includes a shock wave microcatheter 4, an ultrasonic transducer 5, and a vibration drive system 6. The shock wave microcatheter 4 intervenes in the blood vessel 1 of the human body. The front end of the shock wave microcatheter 4 reaches the front section of the blockage inside the blood vessel 1. The rear end of the shock wave microcatheter 4 is drivingly connected to the ultrasonic transducer 5 outside the blood vessel 1. The ultrasonic transducer 5 is electrically connected to the vibration drive system 6. The vibration drive system 6 can control the frequency and amplitude of the forward vibration of the shock wave microcatheter 4, transfer the vibration energy generated by the ultrasonic transducer 5 to the front end of the shock wave microcatheter 4 in the blood vessel 1, and make it generate forward vibration, so that the shock wave microcatheter 4 vibrates directionally and orderly breaks through the calcified and fibrous tissue 2 of the blood vessel 1, allowing the intervention system to enter and pass through the high-resistance stenosis or blockage section.

[0025] Among them, as Figure 3As shown, the ultrasonic transducer 5 includes a horn 51, a vibration transducer part, and a piezoelectric linear actuator part that are connected in sequence. The size and dimensions of the horn 51 can be selected with different structural sizes according to the specific blockage situation after angiography. The ratio of the left - end diameter to the right - end diameter is between 0.2 and 0.8. Different diameter ratios correspond to different amplitudes at the left end, which results in different amplitudes at the catheter end. The purpose is to provide a forward vibration suitable for destroying plaques without excessive vibration, thereby avoiding blood vessel damage. The vibration transducer part includes several annular piezoelectric ceramics 53. At the left and right ends of the annular piezoelectric ceramics 53 along its length direction, there are a first pressing block 52 and a second pressing block 54 respectively. At the right end of the second pressing block 54, there is an elongated block for connecting to the linear guide 58. The piezoelectric linear actuator part includes a cylindrical piezoelectric ceramic 55, a multi - foot base 56, and a linear guide 58. The cylindrical piezoelectric ceramic 55 is arranged on the upper part of the multi - foot base 56. The lower part of the multi - foot base 56 is fixedly arranged on the elongated block of the second pressing block 54. The elongated block of the second pressing block 54 is positioned on the linear guide 58 through at least one fixing member 57 (such as a circlip) to obtain linear motion. When a control signal with a 90° phase difference is applied to the cylindrical piezoelectric ceramic 55, the multi - foot base 56 can generate vibrations from the back to the front in sequence. At any moment, the line formed by the positions of the tips of the multi - foot base 56 forms a sine wave in a water - wave state. When the excitation signal is specified and controlled by the vibration drive system 6, the sine wave can move along the axis of the ultrasonic transducer 5, and the same - direction movement causes the ultrasonic transducer 5 to drive the vibration - wave micro - catheter 4 to generate a precisely controllable linear motion (unidirectional or reciprocating linear motion) in the blood vessel.

[0026] Specifically, in the structure of the above - mentioned intravascular forward - vibration - wave penetrating micro - catheter, the vibration - wave micro - catheter 4 is a single - layer flexible catheter structure, and a hydrophilic coating is provided on the outer side wall of the vibration - wave micro - catheter 4. This hydrophilic coating has the function of reducing protein and bacteria adsorption.

[0027] More specifically, a guide wire 41 for interventional treatment is provided at the front end of the vibration - wave micro - catheter 4. It can reach the front section of the blockage inside the blood vessel 1 along the guide wire 41 (generally seen in the situation during clinical coronary interventional treatment where after the forward guide wire passes through the target lesion, due to the obstruction of severe calcified lesions, other instruments such as balloons and surgical catheters cannot pass through), and directly intervene in the vascular stenosis area 3 formed by calcification and fibrous tissue 2.

[0028] This embodiment also includes a catheter injection part 7, through which surgical instruments (such as special catheters, balloons, or stents, etc.) are introduced into the blood vessel 1.

[0029] Preferably, as Figure 4As shown in the figure, in the above structure: the vibration drive system 6 includes a data acquisition module 61, a data transmission module 62, a data processing module 63, a main control module 64, and a vibration control module 67 that are communicatively connected in sequence. The ultrasonic transducer 5 is connected to the main control module 64 and the vibration control module 67 via a data transmission line, and a data acquisition module 61, a data transmission module 62, and a data processing module 63 are communicatively provided between the ultrasonic transducer 5 and the main control module 64. At the same time, the data acquisition module 61 of the vibration drive system 6 is equipped with a voltage and current acquisition unit, which can monitor the output power of the vibration system in real time, calculate the force at the blockage position according to the real-time change of the power, and feedback it to the vibration control system to adjust the vibration amplitude of the guide wire, dynamically adjust the penetration force and the linear motion speed, so that it can accurately penetrate the plaque, and at the same time avoid excessive amplitude after penetration and damage to the blood vessel inner wall. The vibration wave microcatheter 4 is connected to the vibration control module 67 via the data transmission line. The vibration data generated by the ultrasonic transducer 5 are collected, transmitted, analyzed and processed in sequence by the data acquisition module 61, the data transmission module 62, and the data processing module 63, and the finally processed vibration data are transmitted to the main control module 64, and then transmitted to the vibration control module 67 after being adjusted and processed by the main control module 64 to act on the front end of the vibration wave microcatheter 4, so that the front end of the vibration wave microcatheter 4 generates vibration to break the corresponding calcified and fibrous tissue 2 or directly enter the blood vessel stenosis area 3.

[0030] Among them, the main control module 64 is also communicatively connected to an amplitude adjustment module 65 and a frequency adjustment module 66. The amplitude adjustment module 65 and the frequency adjustment module 66 are connected to the vibration control module 67 for receiving vibration amplitude and frequency control data. The control method controls the vibration mode (standing wave / traveling wave) and direction by adjusting the frequency of the ultrasonic drive and the phase difference of multiple vibration sources. The amplitude adjustment module 65 and the frequency adjustment module 66 can respectively control the temperature aggregation generated by the impact while greatly increasing the directional amplitude through the duty cycle control methods of amplitude and frequency, so as to meet the safety requirements of temperature (less than 42 °C) when vibrating and damaging calcified tissues.

[0031] In the technical solution of the present invention, the coordinated operation among the vibration wave microcatheter 4, the ultrasonic transducer 5, and the vibration drive system 6 is the technical key of this case. Figure 1 and Figure 2 What is mainly shown is the relevant components and connection structures involved in the vibration wave microcatheter 4, the ultrasonic transducer 5, and the vibration drive system 6, as well as the specific structure of the catheter injection part 7. For the data acquisition module 61, the data transmission module 62, the data processing module 63, and the main control module 64 provided in the vibration drive system 6, those of ordinary skill in the art can make conventional settings according to the existing technology, and there are no special requirements for the model selection and combined use thereof in this case.

[0032] In this way, by adopting the technical solution of the present invention, under external control, the vibration wave microcatheter 4 is moved to the front section of the blocked part of the blood vessel 1, and the guide wire 41 is directly inserted into the blood vessel stenosis area 3 formed by the calcification and fibrous tissue 2. The ultrasonic transducer 5 is effectively operated by the vibration drive system 6. Energy is transmitted from the ultrasonic transducer 5 to the vibration wave microcatheter 4, and its front end is controlled to vibrate effectively forward, so as to effectively loosen the calcification and fibrous tissue 2, thus breaking through the blood vessel stenosis area 3 and completing the whole process of the entry and passage of the surgical instrument intervention system.

[0033] It can be found from the above description that, compared with the prior art, after adopting the technical solution of the present invention, ultrasonic vibration is used to stimulate the front end of the vibration wave microcatheter in the blood vessel to generate a forward driving directional vibration, and the vibration effect of the vibration wave microcatheter is used to destroy the calcification and fibrous tissue blocking the lesion in the blood vessel, so as to achieve the purpose that the interventional surgical instrument can pass through smoothly and reach the specified position accurately; moreover, the vibration friction reduction effect of the vibration wave microcatheter can greatly reduce the viscous resistance of the microcatheter in the blood and improve the moving speed of the microcatheter in the blood vessel, thus improving the surgical efficiency.

[0034] The technical solution, working process and implementation effect of the present invention have been described in detail above. It should be noted that the described are only typical examples of the present invention. In addition, the present invention can also have many other specific implementation manners. Any technical solution formed by equivalent replacement or equivalent transformation falls within the scope of protection required by the present invention.

Claims

1. An intravascular forward shock wave type penetrating microcatheter, comprising a shock wave microcatheter (4), an ultrasonic transducer (5) and a vibration drive system (6), characterized in that: The shock wave microcatheter (4) is inserted into the blood vessel (1) of the human body. The front end of the shock wave microcatheter (4) reaches the front section of the blockage inside the blood vessel (1), and the rear end of the shock wave microcatheter (4) is drivingly connected to the ultrasonic transducer (5) outside the blood vessel (1). The ultrasonic transducer (5) includes a horn (51), a vibration transducer part, and a piezoelectric linear actuator part connected in sequence. The vibration transducer part includes several annular piezoelectric ceramics (53). The piezoelectric linear actuator part includes a cylindrical piezoelectric ceramic (55), a multi-foot base (56), and a linear guide (58). The cylindrical piezoelectric ceramic (55) is arranged on the upper part of the multi-foot base (56), the lower part of the multi-foot base (56) is fixedly arranged on the vibration transducer part, and the vibration transducer part is positioned on the linear guide (58) through at least one fixing member (57). And the ultrasonic transducer (5) is electrically connected to the vibration drive system (6).

2. The intravascular forward shock wave type penetrating microcatheter according to claim 1, wherein: The shock wave microcatheter (4) is a single-layer flexible catheter structure.

3. The intravascular forward shock wave type penetrating microcatheter according to claim 2, characterized in that: A hydrophilic coating for reducing protein and bacteria adsorption is provided on the outer side wall of the shock wave microcatheter (4).

4. The intravascular forward shock wave type penetrating microcatheter according to claim 2, wherein: A guide wire (41) for interventional treatment is provided at the front end of the shock wave microcatheter (4).

5. The intravascular forward shock wave type penetrating microcatheter according to claim 4, characterized in that: The guide wire (41) reaches the front section of the blockage inside the blood vessel (1) and directly intervenes in the vascular stenosis area (3) formed by calcification and fibrous tissue (2).

6. The intravascular forward shock wave type penetrating microcatheter according to claim 1, wherein: It further includes a catheter injection part (7) for inserting surgical instruments into the blood vessel (1).

7. The intravascular forward shock wave type penetrating microcatheter according to claim 1, characterized in that: The vibration drive system (6) includes a data acquisition module (61), a data transmission module (62), a data processing module (63), a main control module (64), and a vibration control module (67) that are communicatively connected in sequence. The ultrasonic transducer (5) is connected to the main control module (64) and the vibration control module (67) through a data transmission line. And a data acquisition module (61), a data transmission module (62), and a data processing module (63) are communicatively provided between the ultrasonic transducer (5) and the main control module (64). The shock wave microcatheter (4) is connected to the vibration control module (67) through the data transmission line.

8. The intravascular forward shock wave type penetrating microcatheter according to claim 7, characterized in that: The main control module (64) is also communicatively connected to an amplitude adjustment module (65) and a frequency adjustment module (66), and is connected to the vibration control module (67) for receiving vibration amplitude and frequency control data through the amplitude adjustment module (65) and the frequency adjustment module (66).

9. The intravascular forward shock wave type penetrating microcatheter according to claim 1, characterized in that: First pressing blocks (52) and second pressing blocks (54) are respectively provided at the left and right ends of the annular piezoelectric ceramic (53) along its length direction, and there is an extended block body at the right end of the second pressing block (54) for connecting to the linear guide (58).

10. The intravascular forward shock wave type penetrating microcatheter according to claim 1, characterized in that: The lower part of the multi-foot base (56) is fixedly arranged on the extended block body of the second pressing block (54), and the extended block body of the second pressing block (54) is positioned on the linear guide (58) through at least one fixing member (57).

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