Multifunctional composite surgical device suitable for removal of calcified cardiovascular tissue, and application thereof

Abstract

The present invention relates to a multifunctional composite surgical device suitable for removal of calcified cardiovascular tissue. The device comprises a rotational-atherectomy operation handle, wherein a rotational-atherectomy cutter is connected to an outer face of the head of the rotational-atherectomy operation handle by means of a flexible transmission shaft, a micro-force sensor is mounted on a side of the rotational-atherectomy cutter, an intravascular imaging unit is mounted at the tip of the rotational-atherectomy cutter, an ultrasonic vibration unit and a rotational-atherectomy drive unit are mounted inside the rotational-atherectomy operation handle, and the micro-force sensor, the intravascular imaging unit, the ultrasonic vibration unit and the rotational-atherectomy drive unit are each electrically connected to a control module arranged inside the rotational-atherectomy operation handle. During a rotational-atherectomy process, the rotational-atherectomy cutter is controlled to perform a reciprocating motion at a high frequency within a small range, so as to achieve the aims of reducing the degree of interaction between the cutter and calcified tissue and decreasing the probability of the rotational-atherectomy cutter becoming stuck. In combination with intravascular ultrasonic imaging technology, the internal morphology of blood vessels in the vicinity of the cutting tool is imaged before and after rotational atherectomy, thereby providing data support for operators; and in combination with micro-force sensing technology, an impact force of the cutter can be acquired in real time during the rotational-atherectomy process.

Description

Multifunctional composite surgical device for removing cardiovascular calcified tissue and its application Technical Field

[0001] The present invention relates to a multifunctional composite surgical device suitable for removing cardiovascular calcified tissue and its application, belonging to the technical field of removing vascular calcified tissue. Background Art

[0002] Calcified tissue is a harmful substance formed by the deposition of fat, thrombus, connective tissue, and calcium carbonate on the inner walls of arteries. With age, it thickens and hardens, eventually blocking blood vessels. If calcified tissue is not treated promptly, unstable plaques can rupture and cause cardiovascular events such as acute myocardial infarction and unstable angina. Therefore, research on safe and effective devices for removing vascular calcification without causing other surgical complications is essential.

[0003] Patients with severely calcified blood vessels are typically treated with percutaneous coronary intervention (PCI). PCI is a minimally invasive interventional procedure that uses transcardiac catheterization to clear the blood vessel lumen. Using a percutaneous puncture technique (Seldinger), an expansion balloon or atherectomy device is delivered through the artery to expand the effective flow lumen or modify calcified tissue, thereby improving myocardial blood flow. PCI treatments primarily include percutaneous transluminal angioplasty (PTA), rotational atherectomy (RA), and stent implantation. Doctors rely on angiography or intravascular ultrasound to determine the grade and severity of stenosis and decide whether to use a combination of treatments. Balloons and stents cannot fully expand within the blood vessel, making atherectomy the only effective treatment. Rotational atherectomy is a typical internal grinding process for material removal. It utilizes a roughened micro-cutting tool (olive-shaped and coated with tiny diamond particles) with a surface roughness. Clinically, the primary access routes are through the femoral or radial arteries. During atherectomy, a guidewire, acting as a guiding device, is first moved through the calcified tissue to the distal end for more accurate positioning of the lesion. The atherectomy tool is then delivered along the guidewire to the proximal end of the calcified tissue. A flexible drive shaft drives the tool in high-speed rotation, advancing it in a reciprocating "pecking" motion until it passes through the lesion.

[0004] During rotational atherectomy, the atherectomy tool often becomes stuck or falls off due to improper feeding of the atherectomy tool or incorrect selection of atherectomy parameters. If the atherectomy tool becomes stuck in the calcified tissue during surgery, it will cause serious surgical complications and acute cardiovascular events. Therefore, reducing the probability of atherectomy tool sticking is of great significance for improving the surgical effect of rotational atherectomy. Technical issues

[0005] In view of the deficiencies in the prior art, the technical problem to be solved by the present invention is to provide a multifunctional composite surgical device and its application suitable for removing cardiovascular calcified tissue. Technical Solutions

[0006] In order to solve the above technical problems, the technical solution of the present invention is: a multifunctional composite surgical device suitable for removing cardiovascular calcified tissue, comprising a rotational atherectomy operating handle, the outside of the head of the rotational atherectomy operating handle is connected to a rotational atherectomy tool via a flexible transmission shaft, the side of the rotational atherectomy tool is installed with a micro-force sensor, and the end is installed with an intravascular imaging unit, the interior of the rotational atherectomy operating handle is installed with an ultrasonic vibration unit and a rotational atherectomy drive unit, and the micro-force sensor, intravascular imaging unit, ultrasonic vibration unit and rotational atherectomy drive unit are all electrically connected to a control module arranged inside the rotational atherectomy operating handle.

[0007] Preferably, the atherectomy drive unit includes a DC brushless high-speed motor and a speed-increasing transmission device mounted on the atherectomy operating handle. The speed-increasing transmission device includes a large gear connected to the output shaft of the DC brushless high-speed motor, the large gear is meshed with a small gear, and the small gear is connected to the flexible transmission shaft for rotation.

[0008] Preferably, the intravascular imaging unit includes an ultrasonic transducer, an ultrasonic imaging device and a display. The ultrasonic transducer is integrated into the front end of the atherectomy tool, and the signal is output to the ultrasonic imaging device and converted into an image display.

[0009] Preferably, an oblique groove for accommodating an ultrasonic transducer is provided on the front end of the atherectomy tool, the end face of the ultrasonic transducer forms an angle of 30° with the tool axis, and the ultrasonic signal is emitted obliquely forward of the axial direction of the atherectomy tool.

[0010] Preferably, the flexible transmission shaft is used to connect the outer periphery of the shaft segment of the speed-increasing transmission device with a coaxial interference fit with a capillary, the outer periphery of the capillary is coaxially clearance-fitted with an output sleeve, the output sleeve and the capillary are fixed together by a radial pin, and the output sleeve is coaxially fixed to the pinion.

[0011] Preferably, the shape of the laparoscopic tool is an ellipsoid, the surface of the front half of the long axis of the ellipsoid is arranged with semicircular grooves staggered along the circumferential and axial directions, the groove edges of the grooves are cutting edges, and the surface of the rear half of the long axis of the ellipsoid is smooth and flat.

[0012] Preferably, the athermal tool is in the shape of a cone, and a plurality of groups of stepped tools are axially arranged on the outer circumference of the cone, and each group of stepped tools consists of a plurality of micro blades uniformly distributed around the circumference and extending along the side edge direction.

[0013] Preferably, the outer periphery of the front half of the laparoscopic tool is provided with several micro blades at 90° intervals along the circumferential direction, the middle part of the tool is provided with semicircular grooves staggered along the circumferential direction and the axial direction, the groove edges of the grooves are blades, and the surface of the rear half is smooth and flat, forming a multi-blade tool.

[0014] Preferably, the surface of the micro-force sensor is flush with the surface of the atherectomy tool, and the collision mechanical signal is collected when the tool collides with the calcified tissue.

[0015] The invention discloses an application of a multifunctional composite surgical device suitable for removing cardiovascular calcified tissue, which is applied to remove cardiovascular calcified tissue. Beneficial effects

[0016] Compared with the existing technology, the present invention has the following beneficial effects: the device combines rotational atherectomy with ultrasonic vibration technology to control the small-range high-frequency reciprocating motion of the rotational atherectomy tool during the rotational atherectomy process to reduce the degree of interaction between the tool and calcified tissue and reduce the probability of rotational atherectomy tool entrapment; combined with intravascular ultrasonic imaging technology, it can image the internal morphology of the blood vessels in the area near the tool before and after rotational atherectomy, providing data support for the operator; combined with micro-force sensing technology, it can realize real-time acquisition of the tool collision force during the rotational atherectomy process.

[0017] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG1 is a data waveform diagram of a micro-force sensor according to an embodiment of the present invention.

[0019] FIG2 is a diagram showing the intravascular ultrasound imaging effect according to an embodiment of the present invention.

[0020] FIG3 is a schematic diagram of the internal structure of an embodiment of the present invention.

[0021] FIG4 is a schematic structural diagram of a first type of laparotomy tool according to an embodiment of the present invention.

[0022] FIG5 is a schematic diagram of the structure of a second laparotomy tool according to an embodiment of the present invention.

[0023] FIG6 is a schematic diagram of the structure of a third rotary grinding tool according to an embodiment of the present invention.

[0024] FIG7 is a schematic diagram of the connection structure of the laparotomy tool according to an embodiment of the present invention.

[0025] FIG8 is a first schematic diagram of a flexible transmission shaft connection method according to an embodiment of the present invention.

[0026] FIG9 is a second schematic diagram of a flexible transmission shaft connection method according to an embodiment of the present invention. Modes for Carrying Out the Invention

[0027] The present invention will be further described below with reference to the accompanying drawings and embodiments.

[0028] It should be noted that the following detailed descriptions are exemplary and are intended to provide further explanation of the present application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present application belongs.

[0029] It should be noted that the terms used herein are only for describing specific embodiments and are not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly indicates otherwise, the singular form is also intended to include the plural form. In addition, it should be understood that when the terms "comprise" and / or "include" are used in this specification, they indicate the presence of features, steps, operations, devices, components and / or combinations thereof.

[0030] As shown in Figures 1 to 9, this embodiment provides a multifunctional composite surgical device suitable for removing cardiovascular calcified tissue, including a rotational atherectomy operating handle 1. The outside of the head of the rotational atherectomy operating handle is connected to a rotational atherectomy tool 3 via a flexible transmission shaft 2. The side of the rotational atherectomy tool is installed with a micro-force sensor 4, and the end is installed with an intravascular imaging unit 14. The interior of the rotational atherectomy operating handle is installed with an ultrasonic vibration unit 5 and a rotational atherectomy drive unit 6. The micro-force sensor, intravascular imaging unit, ultrasonic vibration unit and rotational atherectomy drive unit are all electrically connected to a control module 7 provided inside the rotational atherectomy operating handle.

[0031] The atherectomy drive unit is encapsulated inside the atherectomy operating handle as the power source of the device, driving the flexible transmission shaft to operate.

[0032] The ultrasonic vibration unit serves as a processing auxiliary unit and is packaged together with the rotational atherectomy drive unit inside the rotational atherectomy operating handle. When started, it will generate high-frequency axial vibration along the output shaft direction.

[0033] The micro-force sensor is a micro-force sensor based on PVDF film, which can collect mechanical information and transmit it to a host computer.

[0034] In an embodiment of the present invention, the atherectomy drive unit includes a brushless DC high-speed motor 8 mounted on the atherectomy operating handle, and a speed-increasing transmission device. The speed-increasing transmission device includes a large gear 9 connected to the output shaft of the brushless DC high-speed motor. The large gear is meshed with a small gear 10. The small gear is connected to the flexible transmission shaft for rotation, and the speed is amplified by changing the gear ratio.

[0035] In this embodiment of the present invention, the intravascular imaging unit includes an ultrasonic transducer 11, an ultrasonic imaging device, and a display. The ultrasonic transducer is integrated into the front end of the rotational atherectomy tool. The signal is output to the ultrasonic imaging device and converted into an image for display. The intravascular imaging unit is a signal acquisition, processing, and display system based on the ultrasonic transducer.

[0036] In an embodiment of the present invention, an oblique groove 12 for accommodating an ultrasonic transducer is provided on the front end of the atherectomy tool. The end face of the ultrasonic transducer forms a 30° angle with the tool axis. The ultrasonic signal is emitted obliquely in front of the axial direction of the atherectomy tool. When calcified tissue appears in front of the tool, the corresponding ultrasonic radio frequency signal will show a high reflectivity in the image, thereby enabling the measurement of the morphology of the blood vessel cavity in front of the atherectomy tool.

[0037] In an embodiment of the present invention, the ultrasonic transducer is housed inside the inclined groove. The contour of the ultrasonic transducer does not protrude beyond the cutting contour of the tool, will not affect the cutting, and will not collide with calcified tissue. The ultrasonic transducer rotates with the atherectomy tool, and the transducer transmits data via a coaxial line and a rotary joint. After the acquisition card collects the data, filtering, envelope, digital scan conversion and other signal processing are implemented in the host computer, and finally a two-dimensional image of the blood vessel cavity at the front end of the atherectomy tool is presented.

[0038] In an embodiment of the present invention, the ultrasonic vibration unit can generate high-frequency axial vibration when the atherectomy device is in operation, driving the flexible transmission shaft to perform reciprocating high-speed and high-frequency feeding with a small displacement, replacing the traditional manual reciprocating feeding operation, and reducing the occurrence of atherectomy tool jamming, falling off, etc.

[0039] In an embodiment of the present invention, the outer periphery of the flexible transmission shaft, which is used to connect the shaft segment of the speed-increasing transmission device, is coaxially interference-fitted with a capillary 13, and the outer periphery of the capillary is coaxially clearance-fitted with an output sleeve 14. The output sleeve and the capillary are fixedly connected as one through a radial pin 15, and the output sleeve is coaxially fixedly connected to the pinion.

[0040] In an embodiment of the present invention, two opposing surfaces of the outer surface of the capillary tube are flat, and the other two opposing surfaces are arcuate surfaces. The shape of the channel of the output sleeve for inserting the capillary tube is adapted to the outer shape of the capillary tube, thereby limiting the relative circumferential rotation between the capillary tube and the output sleeve. Both the capillary tube and the output sleeve are provided with radially extending interconnected pin holes, and a pin is inserted through the two interconnected pin holes, thereby limiting the relative axial movement between the capillary tube and the output sleeve, ensuring a firm and stable connection between the capillary tube and the output sleeve, and avoiding disconnection and failure of the connection between the capillary tube and the output sleeve due to rotation or vibration.

[0041] In an embodiment of the present invention, a concave edge 16 is coaxially provided on the inner wall of the pin hole of the capillary tube, and a convex edge 17 is coaxially fixed on the outer wall of the pin. The convex edge is used to be embedded with the concave edge to limit the relative axial movement between the pin and the pin hole, thereby ensuring a firm and stable connection between the capillary tube and the output shaft sleeve, and avoiding the connection between the capillary tube and the output shaft sleeve from being disconnected and failing due to rotation or vibration.

[0042] In an embodiment of the present invention, an arc-shaped rocker arm 18 is fixedly provided at the top end of the latch pin, and an arc-shaped groove 19 is provided on the outer periphery of the output shaft sleeve, which passes through the pin hole. The shape of the arc-shaped groove is adapted to the shape of the arc-shaped rocker arm. The other end of the arc-shaped rocker arm is hinged on the arc-shaped groove for swinging. When the arc-shaped rocker arm swings and engages in the arc-shaped groove, the outer periphery of the arc-shaped rocker arm is flush with the outer peripheral wall of the output shaft sleeve.

[0043] In the embodiment of the present invention, the material of the plug is plastic, which can be bent and deformed appropriately to facilitate insertion and removal. The pin hole of the output shaft sleeve has an outward-expanded clearance opening 20, which also facilitates the insertion and removal of the plug.

[0044] In an embodiment of the present invention, the shape of the atherectomy tool is an ellipsoid, and the surface of the front half of the long axis of the ellipsoid is arranged with semicircular grooves 21 staggered along the circumferential and axial directions, and the groove edges of the grooves are blades. The surface of the rear half of the long axis of the ellipsoid is smooth and flat, forming a micro-groove tool. The sharp edges of the semicircular grooves on its surface can play a role similar to a blade during the atherectomy process. Combined with the tiny abrasive particles on the surface of the tool, a grinding and cutting combined processing method is realized during the atherectomy process, thereby improving the efficiency of calcified tissue removal.

[0045] In an embodiment of the present invention, the atherectomy tool is shaped like a cone, with several groups of stepped cutters arranged axially on the outer circumference of the cone. The outer diameters of the stepped cutters gradually increase from the top to the bottom of the cone. Each group of stepped cutters consists of several micro-blades 22 evenly distributed around the circumference, extending along the lateral edges. The stepped cutters are arranged in multiple stages, for example, three, with the diameter gradually increasing from the tip to the tail. This allows the tool to maintain a large effective grinding area during atherectomy, reducing the number of cutter changes during surgery.

[0046] In this embodiment of the present invention, the front half of the atherectomy tool features several micro-blades spaced 90° apart along its outer circumference. The center of the tool features semicircular grooves staggered circumferentially and axially, with the edges of the grooves serving as cutting edges. The rear half of the tool is smooth and flat, forming a multi-blade tool. This specially designed surface microstructure increases the tool's surface roughness, improving the efficiency of atherectomy in removing calcified tissue.

[0047] In this embodiment of the present invention, the surface of the micro-force sensor is flush with the surface of the atherectomy tool, capturing collision mechanical signals when the tool collides with calcified tissue. The atherectomy tool has a pre-reserved wire channel, through which a data cable passes to connect to the micro-force sensor, sharing the internal space of the drive shaft with the ultrasonic transducer data cable for data transmission.

[0048] In an embodiment of the present invention, the multifunctional hybrid surgical device for removing cardiovascular calcified tissue operates as follows: As a minimally invasive interventional therapy device, a flexible drive shaft can be inserted into a human artery through a femoral or radial artery sheath and moved within the vessel until it reaches the calcified narrowing. During this movement, an ultrasonic transducer integrated into the front end of the atherectomy tool continuously transmits ultrasonic signals to the area in front of the tool. The ultrasonic echo signals are analyzed to determine whether the affected area of ​​vascular calcification has been reached. Subsequently, the atherectomy drive provides power to drive the flexible drive shaft to rotate at high speed, thereby driving the atherectomy tool to rotate at high speed within the vessel. During rotation, the tool contacts the hard calcified tissue and grinds away surface material. During the atherectomy process, to prevent excessive single-shot atherectomy tool feed, which could result in excessive grinding collision between the atherectomy tool and the calcified tissue, a gradual, "pecking" approach is typically used to remove the calcified tissue. However, because the atherectomy tool feed is primarily manually adjusted, the feed rate cannot be precisely controlled and overshoot can occur, leading to tool entrapment and dislodgment. A cardiovascular interventional surgical device designed for efficient calcified tissue removal incorporates ultrasonic vibrations during the atherectomy process, enabling the atherectomy tool to not only rotate and abrade calcified tissue at high speed but also reciprocate at a high frequency during feeding. This shortens the duration of contact between the atherectomy tool and calcified tissue, reduces the amount of atherectomy force and temperature generated, and minimizes the likelihood of the tool becoming stuck or dislodged due to the intense grinding of calcified tissue. Simultaneously, a PVDF micro-force sensor integrated into the atherectomy tool surface continuously collects atherectomy impact force data and feeds it back to a host computer for processing and analysis. If excessive atherectomy force is detected, an alarm is triggered, prompting emergency avoidance measures. Measured data from the PVDF micro-force sensor, shown in Figure 1, clearly shows a significant difference in feedback voltage when the tool abrades hard calcified tissue versus soft vascular tissue. This difference in feedback voltage can be used to assess whether residual calcified tissue remains in the area currently being abraded by the atherectomy tool. The ultrasonic transducer integrated at the front end of the atherectomy tool and the supporting data processing software can provide images of blood vessels in the atherectomy area and provide imaging data for the surgical operator. The measured image of the integrated ultrasonic transducer is shown in Figure 2.

[0049] Existing studies have shown that excessive atherectomy force and temperature are important factors that directly lead to complications of atherectomy. The force and temperature generated during atherectomy will directly act on human blood and tissue. Excessive atherectomy force will cause damage and cracks to the inner wall of the blood vessels, and under the impact of arterial blood, vascular dissection and other phenomena will occur; excessive atherectomy temperature will cause blood to aggregate in the atherectomy area to form thrombi, endangering the patient's life. By combining atherectomy, intravascular ultrasound, micro-force feedback and ultrasonic vibration technology, the area in front of the atherectomy tool can be visualized and the reciprocating motion frequency and feed rate of the atherectomy tool can be accurately controlled during atherectomy, shortening the single contact time between the atherectomy tool and calcified tissue. At the same time, the collision force during atherectomy is monitored and the atherectomy process parameters are optimized to reduce the amount of atherectomy force and temperature generated. Therefore, the cardiovascular interventional surgical device proposed by the present invention based on the efficient removal of calcified tissue can not only reduce the probability of atherectomy tool entrapment and detachment, but also reduce the probability of atherectomy complications caused by excessive atherectomy force and temperature.

[0050] The invention discloses an application of a multifunctional composite surgical device suitable for removing cardiovascular calcified tissue, which is applied to remove cardiovascular calcified tissue.

[0051] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any other manner. Any person skilled in the art may utilize the above-disclosed technical content to modify or modify the present invention into equivalent embodiments. However, any simple modifications, equivalent variations, and modifications to the above embodiments that do not depart from the technical content of the present invention and are based on the technical essence of the present invention remain within the scope of protection of the present invention.

Claims

1. A multifunctional composite surgical device suitable for removing cardiovascular calcified tissue, characterized in that: The invention comprises a rotational atherectomy operating handle, wherein the outer side of the head of the rotational atherectomy operating handle is connected to a rotational atherectomy tool via a flexible transmission shaft, a micro-force sensor is installed on the side of the rotational atherectomy tool, and an intravascular imaging unit is installed on the end thereof, an ultrasonic vibration unit and a rotational atherectomy driving unit are installed inside the rotational atherectomy operating handle, and the micro-force sensor, the intravascular imaging unit, the ultrasonic vibration unit and the rotational atherectomy driving unit are all electrically connected to a control module arranged inside the rotational atherectomy operating handle.

2. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The atherectomy drive unit includes a DC brushless high-speed motor and a speed-increasing transmission device mounted on the atherectomy operating handle. The speed-increasing transmission device includes a large gear connected to the output shaft of the DC brushless high-speed motor, the large gear is meshed with a small gear, and the small gear is connected to the flexible transmission shaft for rotation.

3. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The intravascular imaging unit includes an ultrasonic transducer, an ultrasonic imaging device and a display. The ultrasonic transducer is integrated into the front end of the atherectomy tool, and the signal is output to the ultrasonic imaging device and converted into an image display.

4. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 3, characterized in that: The front end of the atherectomy tool is provided with an oblique groove for accommodating an ultrasonic transducer. The end face of the ultrasonic transducer forms an angle of 30° with the tool axis, and the ultrasonic signal is emitted obliquely forward of the axial direction of the atherectomy tool.

5. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 2, characterized in that: The flexible transmission shaft is used to connect the shaft section of the speed increasing transmission device, and the outer periphery of the capillary is coaxially interference fit with a capillary, and the outer periphery of the capillary is coaxially gap fit with an output sleeve. The output sleeve and the capillary are fixedly connected as a whole by a radial pin, and the output sleeve is coaxially fixedly connected to the pinion.

6. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The shape of the rotary grinding tool is an ellipsoid, the surface of the front half of the long axis of the ellipsoid is arranged with semicircular grooves staggered along the circumferential direction and the axial direction, the groove edge of the groove is the blade, and the surface of the rear half of the long axis of the ellipsoid is smooth and flat.

7. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The laparoscopic tool is in the shape of a cone, and a plurality of groups of stepped tools are axially arranged on the outer circumference of the cone. Each group of stepped tools is composed of a plurality of micro blades uniformly distributed around the circumference and extending along the side edge direction.

8. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The front half of the rotary grinding tool has a plurality of micro blades arranged at 90° intervals along the circumferential direction, and the middle part of the tool has semicircular grooves staggered along the circumferential direction and the axial direction. The groove edges of the grooves are blades, and the surface of the rear half is smooth and flat, forming a multi-blade tool.

9. The multifunctional combined surgical device for removing cardiovascular calcified tissue according to claim 1, characterized in that: The surface of the micro-force sensor is flush with the surface of the atherectomy tool, and a collision mechanical signal is collected when the tool collides with the calcified tissue.

10. An application of the multifunctional combined surgical device for removing cardiovascular calcified tissue according to any one of claims 1 to 9, characterized in that: It is applied to the removal of cardiovascular calcified tissue.

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