CN112914679B - Radially deformable thrombectomy device - Google Patents

Abstract

The present application relates to a radially deformable thrombectomy device. The apparatus comprises: the device comprises a guide wire, a grinding head, a nickel-titanium alloy rotary grinding mechanism, a driving shaft, a catheter and a catheter cavity; the guide wire penetrates through the grinding head and the driving shaft, and the grinding head is connected with the driving shaft; the inner cavity gap between the driving shaft and the catheter and the nickel-titanium alloy rotational grinding mechanism forms a catheter cavity which is used for conveying normal saline and sucking thrombus plaques; the catheter comprises a catheter front section and a catheter rear end. This application adopts the nickel titanium alloy material rotational grinding mechanism that has shape memory effect, and in nickel titanium alloy rotational grinding mechanism got into tiny pipeline (like, blood vessel) along with the thrombus clear away apparatus, the piece is heated the inflation uplift between nickel titanium alloy rotational grinding mechanism, and when the drive shaft was rotatory, the piece between after can driving the uplift rotated to can play the effect of clearance silt stifled thing. After the clogging objects are cleaned, the nickel-titanium alloy rotational grinding mechanism can be cooled through the heat transfer of the apparatus, so that the hollow cylindrical state is recovered, and the fine pipeline can be conveniently withdrawn.

Description

Radially deformable thrombectomy device

technical field

The present application relates to the technical field of medical devices, in particular to a radially deformable thrombus removal device.

Background technique

Blood vessels are very elastic. In order to make the blood flow smoothly, the inner wall is very soft; but the blood vessels that have formed arteriosclerosis will thicken and harden, and atheroma (atheroid sclerosis nest) will appear on the inner wall, so the lumen of the blood vessel becomes narrower. The blood circulation is not smooth, and if it continues to deteriorate, it will be completely blocked and form a thrombus.

At present, the treatment methods for vascular thrombosis include anticoagulant therapy, surgical thrombectomy, direct catheter thrombolysis, balloon dilatation and stent implantation, and mechanical thrombectomy; In the process of reaching and leaving the lesion, it is easy to cause blood vessel damage, and the safety is poor.

Contents of the invention

In order to overcome the problems existing in the related technologies, the present application provides a radially deformable thrombus removal device, which utilizes 4D printing nickel-titanium alloy, can radially change the size of the device, and guarantees the smallest shape to enter and Stay away from the thrombotic plaque lesion area to avoid blood vessel damage caused by the device.

This application adopts the following technical solutions to realize:

A radially deformable thrombus removal device, comprising: a guide wire, a grinding head, a nickel-titanium alloy rotational atherectomy mechanism, a drive shaft, a catheter and a catheter lumen;

The guide wire passes through the grinding head and the driving shaft, and the grinding head is connected with the driving shaft;

The lumen space between the driving shaft and the catheter and the nickel-titanium alloy rotary atherectomy mechanism forms a catheter lumen, which is used to deliver normal saline and suck thrombus plaque;

The catheter includes a catheter front end and a catheter rear end;

The nickel-titanium alloy rotary atherectomy mechanism is located between the front end of the catheter and the rear end of the catheter;

The nickel-titanium alloy rotary atherectomy mechanism is a hollow cylinder composed of multiple spacers, and the nickel-titanium alloy rotary atherectomy mechanism can radially expand and deform at 25-37 degrees Celsius.

The grinding head and nickel-titanium alloy rotational atherectomy mechanism are driven by the drive shaft to rotate, and are used for thrombus rotational atherectomy and removal.

In one embodiment of the present application:

The nickel-titanium alloy rotary atherectomy mechanism is made of nickel-titanium alloy material, and is subjected to 4D printing and repeated thermomechanical cycle treatment in the phase change interval, so that it has a two-way memory effect.

In one embodiment of the present application: the two-way memory effect includes forming and maintaining two stable forms:

Form 1: The nickel-titanium alloy rotary atherectomy mechanism is in the shape of a slender hollow cylinder, and is in close contact with the drive shaft to keep the smallest volume;

Form 2: The nickel-titanium alloy rotary atherectomy mechanism automatically expands and deforms from the original hollow cylinder to an ellipse to achieve the largest volume form;

Form 1 and form 2 can be switched by changing the temperature.

In one embodiment of the present application:

Form 1 and form 2 can be switched by changing the temperature, including:

Control its morphological changes by the temperature of body fluid and saline;

When the thrombus is removed, the catheter enters the target thrombus plaque lesion area, and the front end of the catheter and the rear end of the catheter in the connected state are separated. The deformation temperature of the nickel-titanium alloy rotary atherectomy mechanism after thermomechanical cycle treatment is consistent with the body fluid temperature, and the nickel-titanium alloy rotary atherectomy mechanism automatically expands and deforms.

In one embodiment of the present application:

Form 1 and form 2 can be switched by changing the temperature, including:

When the thrombus plaque is removed, normal saline is delivered to the surrounding lumen of the blood vessel through the catheter lumen, and the recovery deformation temperature of the nickel-titanium alloy rotary atherectomy mechanism after repeated thermomechanical cycle treatment in the phase change interval is consistent with the temperature of normal saline, and the nickel-titanium alloy The shape of the rotary atherectomy mechanism is restored to a hollow cylindrical shape, and the front end of the catheter and the rear end of the catheter are connected, so that the nickel-titanium alloy rotary atherectomy mechanism is no longer exposed to blood vessels.

In one embodiment of the present application:

Before the removal of clotted plaque is complete, it also includes:

If the thrombosis and plaque debris formed by rotational grinding exceeds the size of the human body's absorbable particles, the thrombosis and plaque debris is drawn out of the body through the negative pressure suction of the catheter lumen;

If the size of the particles of thrombosis and plaque formed by rotational grinding can be absorbed by the human body, the thrombosis and plaque debris will be absorbed by the human body at this time.

In one embodiment of the present application:

Before the removal of clotted plaque is complete, it also includes:

The high temperature generated by high-speed rotational atherectomy is lubricated and cooled by the physiological saline delivered through the catheter lumen.

In one embodiment of the present application:

The repeated thermomechanical cycle treatment in the phase change interval includes:

The M _f (martensitic phase transition end temperature) point of the nickel-titanium alloy rotary grinding mechanism corresponds to the temperature of normal saline, and the A _f (austenite phase transition end temperature) point corresponds to the human body temperature, and its parent phase shape is elliptical. It is cooled to the temperature of normal saline in vitro, and deformed into a deformed phase, that is, a hollow cylinder shape.

In one embodiment of the present application:

The grinding head diameter dimension is larger than the diameter dimension of the conduit.

In one embodiment of the present application:

The guide wire is used to guide the movement of the instrument and the rotation of the drive shaft.

The technical solution provided by the present application may include the following beneficial effects: using a nickel-titanium alloy material rotational atherectomy mechanism with a shape memory effect, when the nickel-titanium alloy rotational atherectomy mechanism enters a tiny channel (such as a blood vessel) along with a thrombus removal device, the nickel-titanium alloy material The alloy rotary atherectomy mechanism is affected by the body temperature of the human body. The spacer of the nickel-titanium alloy rotary atherectomy mechanism expands and bulges when heated, causing a gap between the spacer and the spacer. When the drive shaft rotates, it can drive the raised spacer to rotate. , so as to be able to play the role of clearing the silt. After clearing the blockage, the nickel-titanium alloy rotary atherectomy mechanism can be cooled through the heat transfer of the instrument, so that it returns to the state of the hollow cylinder, which is convenient for pulling out the tiny pipe.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application.

Description of drawings

The above and other objects, features and advantages of the present application will become more apparent by describing the exemplary embodiments of the present application in more detail with reference to the accompanying drawings, wherein, in the exemplary embodiments of the present application, the same reference numerals generally represent same parts.

Fig. 1 is a schematic structural diagram of a radially deformable thrombus removal device shown in an embodiment of the present application;

Fig. 2 is a schematic structural view of a thrombus removal device for performing rotational atherectomy to form a catheter channel shown in an embodiment of the present application;

Fig. 3 is a schematic structural view of a deformed thrombus removal device shown in an embodiment of the present application after completion of the catheter channel;

Fig. 4 is a schematic diagram of a thrombus removal device shown in an embodiment of the present application to remove thrombus plaque;

Fig. 5 is a schematic diagram of the recovery of deformation of the thrombus removal device shown in the embodiment of the present application after removing the thrombus;

detailed description

Preferred embodiments of the present application will be described in more detail below with reference to the accompanying drawings. Although preferred embodiments of the present application are shown in the drawings, it should be understood that the present application may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this application will be thorough and complete, and will fully convey the scope of this application to those skilled in the art.

Embodiment one:

At present, the treatment methods for vascular thrombosis include anticoagulant therapy, surgical thrombectomy, direct catheter thrombolysis, balloon dilatation and stent implantation, and mechanical thrombectomy; In the process of reaching and leaving the lesion, it is easy to cause blood vessel damage, and the safety is poor.

In view of the above technical problems, embodiments of the present application provide a radially deformable thrombus removal device.

Fig. 1 is a schematic structural view of a radially deformable thrombus removal device shown in an embodiment of the present application.

Referring to FIG. 1 , an embodiment of the radially deformable thrombus removal device in the embodiment of the present application includes:

Guide wire 1, grinding head 2, nickel-titanium alloy rotational atherectomy mechanism 3, drive shaft 4, catheter 5 and catheter lumen 6;

The guide wire 1 is connected with the grinding head 2, and the grinding head 2 is connected with the drive shaft 4;

The inner cavity space between the drive shaft 4 and the catheter 5 and the nickel-titanium alloy rotary atherectomy mechanism 3 forms a catheter lumen 6, and the catheter lumen 6 is used to transport physiological saline and suck thrombus plaque;

The conduit 5 includes a conduit front section 51 and a conduit rear end 52;

The nickel-titanium alloy rotational atherectomy mechanism 3 is located between the catheter front end 51 and the catheter rear end 52;

The nickel-titanium alloy rotary atherectomy mechanism 3 is a hollow cylinder composed of a plurality of spacers, and the nickel-titanium alloy rotary atherectomy mechanism 3 can radially expand and deform at 25-37 degrees Celsius.

It is understandable that nickel-titanium alloy is a shape memory alloy, a special alloy that can automatically restore its own plastic deformation to its original shape at a certain temperature, and is widely used in the field of interventional medicine.

In the embodiment of the present application, the nickel-titanium alloy rotary atherectomy mechanism 3 is made of nickel-titanium alloy material, which is subjected to 4D printing and repeated thermomechanical cycle treatment in the phase change interval, so that it has expansion deformation and two-way memory effect.

4D printing is an additive manufacturing technology for intelligent materials. It uses advanced material composite technology to integrate sensitive components, drive components and even control components into the base material, so that the material structure can perceive changes in external or internal states and characteristics, and can be based on The ability to identify the specific characteristics of a change in order to make a reasonable response.

The grinding head 2 and the nickel-titanium alloy rotational atherectomy mechanism 3 are driven to rotate by the drive shaft 4 for rotational atherectomy and thrombus removal.

In the embodiment of the present application, due to the use of the nickel-titanium alloy material rotational atherectomy mechanism 3 with shape memory effect, when the nickel-titanium alloy rotational atherectomy mechanism 3 enters the fine channel (such as the blood vessel lumen 10) along with the thrombus removal instrument, the nickel The titanium alloy rotary atherectomy mechanism 3 is affected by the body temperature of the human body, and the spacer of the nickel-titanium alloy rotary atherectomy mechanism 3 is heated and expanded to bulge, so that a gap is generated between the spacer pieces, and at the same time, when the drive shaft 4 rotates, it can drive the raised spacers. The blade rotates, so that it can play the role of clearing the blockage. After clearing the blockage, the nickel-titanium alloy rotary atherectomy mechanism 3 can be cooled through the heat transfer of the instrument, so as to return to the state of the hollow cylinder, which is convenient for pulling out the tiny pipe.

Embodiment two:

In practical application scenarios, the present application provides a radially deformable thrombus removal device for the removal of thrombus plaques in completely occluded vessels.

Fig. 1 is a schematic structural diagram of a radially deformable thrombus removal device shown in an embodiment of the present application;

Fig. 2 is a schematic structural view of a thrombus removal device for performing rotational atherectomy to form a catheter channel shown in an embodiment of the present application;

Fig. 3 is a schematic structural view of a deformed thrombus removal device shown in an embodiment of the present application after completion of the catheter channel;

Fig. 4 is a schematic diagram of a thrombus removal device shown in an embodiment of the present application to remove thrombus plaque;

Fig. 5 is a schematic diagram of the recovery of deformation of the thrombus removal device shown in the embodiment of the present application after removing the thrombus;

Referring to Figures 1-5, an embodiment of the radially deformable thrombus removal device in the embodiment of the present application includes:

The lesion site of target thrombosis plaque 8 is detected by means of intravascular ultrasound (IVUS) or optical coherence tomography (OCT). After the completion, the nickel-titanium alloy rotary atherectomy mechanism 3 is subjected to repeated thermomechanical cycle treatment in the phase change interval, so that the nickel-titanium alloy rotary atherectomy mechanism 3 has a two-way shape memory effect that changes in form one and form two through external temperature changes;

In the embodiment of the present application, the M _f (martensitic transformation end temperature) point of repeated thermomechanical cycle treatment in the phase transformation interval of the nickel-titanium alloy rotary atherectomy mechanism 3 is set to the normal saline temperature (25°), A _f (Austenitic Body phase transition end temperature) point is set to human body temperature (37 °), so that the shape of the 3 parent phases of the nickel-titanium alloy rotary atherectomy mechanism is an elliptical shape, that is, the first shape is expanded into a plurality of interlayers; it is cooled to 25 °C in vitro. °After deformation, it becomes a deformed phase, that is, the second form is a hollow cylinder form in which multiple interlamellae are closely attached;

At this time, the nickel-titanium alloy rotational atherectomy mechanism 3 is assembled into the entire thrombus removal device, and the two ends of the catheter front end 51 and the catheter rear end 52 of the catheter 5 are connected, so that the nickel-titanium alloy rotational atherectomy mechanism 3 is enclosed in the inner cavity of the catheter 5 .

For completely occluded blood vessels, under the guidance of the guide wire 1, the entire thrombus removal device reaches the lesion site of the target thrombosis plaque 8, and the drive shaft 4 drives the grinding head 2 at the front end of the catheter 5 to rotate at a high speed. The grinding head 2 is a traditional nickel-plated diamond The grinding head has a diameter greater than that of the conduit 5 (1.0-1.5mm), and its rotating speed can reach 100000r/min-140000r/min.

Simultaneously, the physiological saline 9 is delivered to the catheter lumen 6. Since the front end 51 of the catheter is connected to the rear end 52 of the catheter, the saline 9 can flow out from the front end of the catheter 5, and has a lubricating and cooling effect on the grinding head 2 of the high-speed rotary atherectomy.

When the grinding head 2 is rotated to form a catheter channel, the whole thrombus removal device moves back to the front end of the thrombus plaque 8. At this time, the delivery of normal saline 9 to the catheter lumen 6 is stopped, and the front end 51 of the catheter is separated from the rear end 52 of the catheter. The grinding mechanism 3 is exposed to the inner cavity 10 of the blood vessel, deformed by the body temperature, and returns to the ellipsoidal shape of the parent phase; at this time, the drive shaft 4 drives the intermediate piece of the nickel-titanium alloy grinding head 3 for rotational grinding, and the rotation speed is less than 50000r/min .

If the thrombus plaque debris 11 formed by the rotational abrasion exceeds the size of the absorbable particles of the human body, the thrombus plaque debris 11 is drawn out of the body through the negative pressure suction of the catheter lumen 6 .

After the thrombus plaque 8 that cannot be absorbed by the human body is removed, the negative pressure suction of the catheter lumen 6 is stopped, and the normal saline 9 with a temperature of 25° is delivered to the catheter lumen 6, and the physiological saline 9 at a specific temperature makes the nickel titanium spin The shape of the disc of the grinding mechanism 3 changes, and it deforms again into a deformed phase, that is, a hollow cylinder shape. At this time, the two ends of the catheter front end 51 and the catheter rear end 52 are connected, and the delivery of normal saline 9 to the catheter lumen 6 is stopped. The entire thrombus removal device is removed from the body under the guidance of the patient.

In the embodiment of the present application, by setting the grinding head 2 at the front end of the catheter 6, the completely occluded blood vessel can be subjected to rotational atherectomy through the grinding head 2, so as to facilitate the crushing and removal of the occluded thrombus plaque 8.

During the removal process of the thrombus plaque 8 , the spacer of the nickel-titanium alloy grinding head 3 self-expands to the target diameter, which facilitates further removal of the thrombus plaque 8 by rotational abrasion.

When the thrombus removal device reaches and moves away from the thrombus plaque 8 lesion area, the spacer of the nickel-titanium alloy grinding head 3 self-restores to the smallest shape, that is, a hollow cylinder, which is beneficial for the thrombus removal device to enter and leave the body, and prevents the device from causing blood vessels. damage, improve operability and safety.

Embodiment three:

In a practical application scenario, the present application provides a radially deformable thrombus removal device for the method of removing thrombus plaque in a non-completely occluded vessel.

Fig. 1 is a schematic structural diagram of a radially deformable thrombus removal device shown in an embodiment of the present application;

Fig. 4 is a schematic diagram of a thrombus removal device shown in an embodiment of the present application to remove thrombus plaque;

Fig. 5 is a schematic diagram of the recovery of deformation of the thrombus removal device shown in the embodiment of the present application after removing the thrombus;

Referring to Fig. 1, Fig. 4 and Fig. 5, an embodiment of the radially deformable thrombus removal device in the embodiment of the present application includes:

The lesion site of the target thrombosis plaque 8 is also detected by vascular ultrasound (IVUS) or optical coherence tomography (OCT) and other detection methods, and the nickel-titanium alloy rotary abrading mechanism 3 is 4D printed according to the detection situation, After the printing is completed, the nickel-titanium alloy rotational atherectomy mechanism 3 is subjected to repeated thermomechanical cycle treatment in the phase change interval, so that the nickel-titanium alloy rotational atherectomy mechanism 3 has a two-way shape memory effect in which the first and second forms can be changed by external temperature changes.

In the embodiment of the present application, the steps of repeating the thermomechanical cycle treatment and assembling into the whole thrombus removal device in the phase transition zone of the nickel-titanium alloy rotary atherectomy mechanism 3 are consistent with Example 2, and will not be repeated in the embodiment of the present application.

For blood vessels that are not completely occluded, after repeated thermomechanical cycle treatment in the phase transition interval of the nickel-titanium alloy rotational atherectomy mechanism 3 and assembly into the entire thrombus removal device, under the guidance of the guide wire 1, the entire thrombus removal device 3 directly reaches the target For the lesion site of thrombosis plaque 8, it is not necessary to use the grinding head 2 at the front end of the catheter 5 to perform rotational abrasion on the thrombosis plaque to form a catheter channel, but the front end 51 of the catheter is separated from the rear end 52 of the catheter, so that the nickel-titanium alloy rotational atherectomy mechanism 3 is exposed to In the inner lumen 10 of the blood vessel, the shape changes under the influence of body temperature, that is, it returns to the parent phase ellipsoid.

The drive shaft 4 drives the interpiece of the nitinol grinding head 3 for rotational abrading at a rotational speed of less than 50,000 r/min, and the thrombus and plaque debris 11 formed after the rotational abrading is sucked out of the body by the negative pressure suction of the catheter 6 .

After the thrombus plaque 8 is cleared, the temperature of 25 ° normal saline 9 is also delivered to the catheter lumen 6, and the physiological saline 9 at a specific temperature will make the disc of the nickel-titanium rotary atherectomy mechanism 3 undergo a morphological change, and be deformed into a deformed phase again, i.e. Hollow cylinder shape, now the catheter front end 51 and the catheter rear end 52 are connected at both ends, the delivery of normal saline 9 to the catheter lumen 6 is stopped, and the entire thrombus removal device is taken out from the body under the guidance of the guide wire 1 .

In the embodiment of the present application, for non-completely occluded blood vessels, under the guidance of the guide wire 1, the entire thrombus removal device 3 directly reaches the target lesion site of the thrombus plaque 8, without using the grinding head 2 at the front end of the catheter 5 to treat the thrombus plaque 8 Atherectomy creates ductal channels.

The radially deformable thrombus removal device provided by the embodiment of the present application also self-expands to the diameter of the target through the spacer of the nickel-titanium alloy grinding head 3 during the process of removing the thrombus plaque 8, which is conducive to the rotation of the thrombus plaque 8. Grind to clear.

At the same time, when the thrombus removal device reaches and is far away from the 8 lesions of the thrombus plaque, the spacer of the nickel-titanium alloy grinding head 3 self-restores to the smallest shape, that is, a hollow cylinder, which is beneficial for the thrombus removal device to enter and leave the body, avoiding the Cause blood vessel damage, improve operability and safety.

Having described various embodiments of the present application above, the foregoing description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and alterations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principle of each embodiment, practical application or improvement of technology in the market, or to enable other ordinary skilled in the art to understand each embodiment disclosed herein.

Claims (9)

1. A radially deformable thrombus removal device is characterized in that it comprises: a guide wire (1), a grinding head (2), a nickel-titanium alloy rotary atherectomy mechanism (3), a drive shaft (4), a catheter (5) ) and catheter lumen (6); The guide wire (1) passes through the grinding head (2) and the driving shaft (4), and the grinding head (2) is connected to the driving shaft (4); The lumen space between the drive shaft (4) and the catheter (5) and the nickel-titanium alloy rotational atherectomy mechanism (3) forms a catheter lumen (6), and the catheter lumen (6) is used to transport physiological Saline and aspiration of clotted plaque; The catheter (5) comprises a catheter front end (51) and a catheter rear end (52); The nickel-titanium alloy rotational atherectomy mechanism (3) is located between the catheter front end (51) and the catheter rear end (52); The nickel-titanium alloy rotational atherectomy mechanism (3) is a hollow cylinder composed of a plurality of spacers, and the nickel-titanium alloy rotational atherectomy mechanism (3) can radially expand and deform at 25-37 degrees Celsius; The grinding head (2) and the nickel-titanium alloy rotational atherectomy mechanism (3) are driven to rotate by the drive shaft (4), for thrombus rotational atherectomy and removal; The diameter of the grinding head (2) is larger than the diameter of the conduit (5). 2. The radially deformable thrombus removal device according to claim 1, characterized in that it comprises: The nickel-titanium alloy rotary atherectomy mechanism (3) is made of nickel-titanium alloy material, and is subjected to 4D printing and repeated thermomechanical cycle treatment in the phase change interval, so that it has a two-way memory effect. 3. The radially deformable thrombus removal device according to claim 2, characterized in that it comprises: The two-way memory effect includes forming and maintaining two stable forms: Form one: the nickel-titanium alloy rotary atherectomy mechanism (3) is in the shape of an elongated hollow cylinder, and is in close contact with the drive shaft (4), so as to maintain the smallest volume form; Form 2: the nickel-titanium alloy rotary atherectomy mechanism (3) automatically expands and deforms from the original hollow cylinder to an ellipse to achieve the largest volume form; The form 1 and form 2 can be switched by changing the temperature. 4. The radially deformable thrombus removal device according to claim 3, characterized in that, The form one and form two can be switched by changing the temperature, including: Control its morphological changes by the temperature of body fluid temperature and physiological saline (9); When the thrombus is removed, the catheter (5) enters the lesion area of the target thrombus plaque (8), and the connected catheter front end (51) and catheter rear end (52) are separated. At this time, the nickel-titanium alloy rotational atherectomy mechanism ( 3) The deformation temperature of the nickel-titanium alloy rotary atherectomy mechanism (3) exposed to the blood vessel wall (7) and the blood vessel lumen (10) after repeated thermomechanical cycle treatment in the phase change interval is consistent with the body fluid temperature, and the nickel-titanium alloy The alloy rotary grinding mechanism (3) automatically expands and deforms. 5. The radially deformable thrombectomy device according to claim 4, characterized in that, The form one and form two can be switched by changing the temperature, and also include: When the thrombus plaque is removed, the normal saline (9) is delivered to the blood vessel lumen (10) through the catheter lumen (6), and the nickel-titanium alloy rotary atherectomy mechanism (3 ) recovery deformation temperature is consistent with the temperature of normal saline, the shape of the nickel-titanium alloy rotary atherectomy mechanism (3) returns to a hollow cylinder, and the two ends of the catheter front end (51) and the catheter rear end (52) are connected, so that the The nickel-titanium alloy rotary atherectomy mechanism (3) is no longer exposed to blood vessels. 6. The radially deformable thrombectomy device according to claim 5, characterized in that, Before the removal of thrombus plaque is completed, it also includes: If the thrombus plaque debris (11) formed by the rotational grinding exceeds the size of the absorbable particles of the human body, the thrombus plaque debris (11) is extracted from the body through the negative pressure suction of the catheter lumen (6); If the thrombus plaque debris (11) formed by the rotational grinding can be absorbed by the human body, the thrombosis plaque debris (11) is absorbed by the human body at this time. 7. The radially deformable thrombus removal device according to claim 5, characterized in that, Before the removal of thrombus plaque is completed, it also includes: The high temperature generated by the high-speed rotational grinding is lubricated and cooled by the physiological saline (9) delivered by the catheter lumen (6). 8. The radially deformable thrombectomy device according to claim 2, characterized in that, The repeated thermomechanical cycle treatment in the phase change interval includes: The M _f (martensitic phase transition end temperature) point of the nickel-titanium alloy rotary atherectomy mechanism (3) corresponds to the temperature of normal saline (9), and the A _f (austenite phase transition end temperature) point corresponds to the body temperature, and its parent The phase shape is an ellipse shape, which is cooled to the temperature of normal saline in vitro, and deformed into a deformed phase, that is, a hollow cylinder shape. 9. The radially deformable thrombectomy device according to claim 1, characterized in that, The guide wire (1) is used to guide the movement of the instrument and the rotation of the drive shaft (4).

Images