Rotary grinding catheter with built-in medicine balloon

Abstract

The invention discloses a rotary grinding catheter capable of being internally provided with a medicine balloon, and relates to the technical field of medical apparatuses and instruments, the rotary grinding catheter comprises a handle shell and a rotary grinding mechanism; the rotary grinding mechanism comprises a grinding head assembly used for grinding calcified tissue and further comprises a medicine balloon mechanism. The medicine balloon mechanism is arranged in the grinding head assembly in a matched mode. The medicine balloon mechanism is arranged in the grinding head assembly in advance, so that a lesion position can be rotationally ground through the grinding head assembly, then the grinding head assembly is immediately separated from the medicine balloon mechanism, the medicine balloon mechanism is exposed, medicine can be directly applied to the lesion position, the treatment period is greatly shortened, and the treatment efficiency is improved. The operation time prolonging and possible vascular injury caused by secondary intervention are avoided, and the operation effect is improved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a rotational atherectomy catheter with an implantable drug-eluting balloon. Background Technology

[0002] With the continuous development of medical technology, percutaneous coronary intervention has been widely used for more complex coronary artery lesions. However, severe coronary artery calcification remains a challenge and risk point in interventional treatment. Currently, rotational atherectomy is considered an important means of treating severe coronary artery calcification.

[0003] Current rotational atherectomy mainly uses a high-speed rotating burr head with diamond particles to grind the calcified intima of the coronary arteries into tiny particles, thereby removing the plaque that blocks the blood vessel lumen.

[0004] However, existing rotational atherectomy devices still have the following shortcomings: When treating vascular lesions, existing rotational atherectomy devices still have some limitations. Generally, drug-eluting balloons or stents need to be implanted after rotational atherectomy to restore coronary blood flow. However, the implantation of drug-eluting balloons or stents requires a second intervention after rotational atherectomy. The second intervention not only prolongs the operation time and reduces the efficiency of the operation, but also easily causes damage to the vascular wall during the second intervention. Therefore, there is an urgent need to develop a new type of rotational atherectomy catheter device. Summary of the Invention

[0005] The purpose of this invention is to provide a rotational atherectomy catheter with an implantable drug-eluting balloon, in order to solve the technical problem that in the prior art, rotational atherectomy catheter devices require a second intervention to implant a drug-eluting balloon or drug-eluting stent after rotational atherectomy, which reduces surgical efficiency and easily causes damage to the blood vessel wall.

[0006] The technical problem to be solved by this invention can be achieved through the following technical solution: A rotational abrasion catheter with an implantable drug-eluting balloon includes a handle housing and a rotational abrasion mechanism; the rotational abrasion mechanism includes a grinding head assembly for grinding calcified tissue and a drug-eluting balloon mechanism. The drug-eluting balloon mechanism is disposed inside the grinding head assembly; the drug-eluting balloon mechanism and the grinding head assembly are detachably connected, and the handle housing is used to control the separation of the grinding head assembly and the drug-eluting balloon mechanism.

[0007] Preferably, the grinding mechanism further includes a transmission tube, one end of which is rotatably disposed inside the handle housing, and the other end is connected to the grinding head assembly. The handle housing is provided with a drive mechanism for driving the transmission tube to rotate.

[0008] Preferably, the drug-eluting balloon mechanism includes a balloon catheter and a drug-eluting balloon body. The balloon catheter extends through the transmission tube, and there is a gap between the balloon catheter and the transmission tube. An operating connector is installed at the proximal end of the balloon catheter, and the drug-eluting balloon body is fixedly installed at the distal end of the balloon catheter and is fitted within the grinding head assembly. The operating connector is used to control the expansion or contraction of the drug-eluting balloon body. Preferably, the operating connector is provided with a guidewire port and a liquid port, the balloon catheter is provided with a liquid passage chamber and a guidewire chamber, and the liquid passage chamber is connected to the liquid port, the drug balloon body is connected to the liquid passage chamber, and the guidewire chamber is connected to the guidewire port.

[0009] Preferably, the grinding head assembly includes two half-grinding head housings, which are symmetrically distributed; one half-grinding head housing is fixedly connected to the transmission tube, and the other half-grinding head housing is slidably sleeved on the distal end of the balloon catheter; the half-grinding head housing connected to the transmission tube is configured as an electromagnet; and a fixed magnet is installed on the other half-grinding head housing.

[0010] Preferably, the grinding head assembly includes a grinding head component and a through cavity. The grinding head component is fixedly connected to the transmission tube, and the through cavity is opened through the grinding head component, with the drug capsule fitting inside the through cavity.

[0011] Preferably, the drive mechanism includes a drive motor, a drive gear, and a driven gear ring. The drive motor is fixedly installed inside the handle housing. The drive gear is coaxially fixedly connected to the main shaft end of the drive motor. A support sleeve is rotatably provided inside the handle housing and coaxially fixedly connected to the transmission tube. The driven gear ring meshes with the drive gear, and the driven gear ring is coaxially fixedly connected to the support sleeve.

[0012] Preferably, the handle housing has a through groove near the drive gear, and a sliding button is slidably connected to the through groove; a locking rod that cooperates with the drive gear is fixedly connected to the side of the sliding button near the inside of the handle housing.

[0013] Preferably, a Luer connector for connecting an external coolant delivery pump is installed on one outer wall of the handle housing, and an outer tube fixing seat is fixedly installed inside the handle housing. An outer tube body is sleeved on the outside of the transmission tube and fixedly connected to the outer tube fixing seat. A delivery chamber communicating with the Luer connector is opened in the side wall of the outer tube body.

[0014] Preferably, a fixing valve is fixedly installed on the side of the handle housing away from the grinding head assembly, and the balloon catheter passes through the fixing valve, which is used to lock the balloon catheter.

[0015] The beneficial effects of this invention are: 1. The present invention pre-embeds the drug-eluting balloon mechanism in the grinding head assembly, which facilitates the grinding of the lesion site by first grinding the lesion site with the grinding head assembly, and then immediately separates the grinding head assembly from the drug-eluting balloon mechanism to expose the drug-eluting balloon mechanism, so as to directly apply the drug to the lesion site. This greatly reduces the treatment cycle, avoids the prolongation of operation time and possible vascular damage caused by secondary intervention, and improves the surgical effect.

[0016] 2. The present invention can set the grinding head assembly as two halves of the grinding head housing, one half of the grinding head housing is an electromagnetic element and the other half of the grinding head housing is a permanent magnet element. It is convenient to change the magnetic pole generated by controlling the current direction of the half of the grinding head housing of the electromagnetic element, so that the two halves of the grinding head housing can be magnetically attracted together to form a complete grinding head for rotary grinding, or separated by repulsive magnetic force to expose the internal drug capsule for drug application. The operation is convenient and effective.

[0017] 3. The present invention can also configure the grinding head assembly as a grinding head with a through cavity, so that the drug capsule is located in the through cavity. After the grinding is completed by the grinding head, the grinding head can be directly retracted to expose the drug capsule inside for direct drug application.

[0018] 4. In this invention, the drug is prepared in advance on the surface of the drug balloon. By inflating the drug balloon, it can be directly applied to the lesion site, avoiding loss during drug delivery and improving the therapeutic effect.

[0019] 5. This invention integrates the drug-eluting balloon and the grinding head assembly into a single design, reducing the overall size of the rotational atherectomy catheter, saving space, effectively avoiding vascular damage caused by occupying additional lumen, improving the safety and reliability of the surgery, reducing the use of guidewire exchange and related consumables, lowering surgical costs, simplifying the surgical procedure, and improving the economy and convenience of the surgery. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of the present invention; Figure 2 This is a schematic diagram of the overall cross-sectional structure of the present invention; Figure 3 yes Figure 2 Schematic diagram of the cross-sectional structure at point AA; Figure 4 yes Figure 2 A magnified schematic diagram of the partial structure at point A in the middle; Figure 5 yes Figure 2 A magnified schematic diagram of the local structure at point B; Figure 6 This is a schematic diagram showing the state of the grinding head assembly when it is separated in the form of a half-grinding head housing in this invention; Figure 7 This is a schematic diagram of the structure of the grinding head assembly using a complete grinding head component in this invention; Figure 8 This is a schematic diagram of the structure in this invention where the drug capsule extends from the complete grinding head.

[0021] Explanation of reference numerals in the attached figures: 1. Handle housing; 2. Grinding head assembly; 21. Grinding head component; 22. Through cavity; 23. Semi-grinding head housing; 3. Drug balloon mechanism; 31. Balloon catheter; 32. Drug balloon body; 33. Operating connector; 34. Guide wire port; 35. Liquid inlet; 36. Liquid passage cavity; 37. Guide wire cavity; 38. Inner sleeve; 6. Transmission tube; 7. Drive mechanism; 71. Drive motor; 72. Driving gear; 73. Driven gear ring; 74. Support rotating sleeve; 8. Through groove; 81. Slide button; 82. Locking rod; 9. Luer connector; 91. Outer tube fixing seat; 92. Outer tube body; 10. Fixing valve. Detailed Implementation

[0022] The specific embodiments of the present invention will be described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments.

[0023] Example 1

[0024] like Figures 1-8 As shown, a rotational atherectomy catheter with an internally mounted drug-eluting balloon includes a handle housing 1 and a rotational atherectomy mechanism. The rotational atherectomy mechanism includes a grinding head assembly 2 for grinding calcified tissue. The rotational atherectomy catheter also includes a drug-eluting balloon mechanism 3, which is disposed inside the grinding head assembly 2 to facilitate reaching the location of the calcified tissue along with the grinding head assembly 2. Since it is located inside the grinding head assembly 2, it avoids obstructing the grinding head assembly 2 from grinding. The drug-eluting balloon mechanism 3 is detachably connected to the grinding head assembly 2. The handle housing 1 is used to control the separation of the grinding head assembly 2 and the drug-eluting balloon mechanism 3, thereby facilitating direct contact with the lesion site for drug application after grinding is completed.

[0025] The grinding mechanism also includes a transmission tube 6, one end of which is rotatably disposed inside the handle housing 1, and the other end is connected to the grinding head assembly 2. The handle housing 1 is provided with a drive mechanism 7 for driving the transmission tube 6 to rotate, and a control switch can be directly set on the handle housing 1, so as to facilitate the transmission tube 6 to drive the grinding head assembly 2 to rotate at high speed for grinding.

[0026] It should be noted that the transmission tube 6 can only rotate on the handle housing 1 and cannot slide laterally relative to the handle housing 1, as it is subject to a limit.

[0027] Example 2

[0028] Based on Example 1, and referring to Figure 2 and Figure 5 As shown, the drug-eluting balloon mechanism 3 includes a balloon catheter 31 and a drug-eluting balloon body 32. The balloon catheter 31 slides laterally through the handle housing 1 and also laterally through the transmission tube 6, with a gap between them to prevent friction between the transmission tube 6 and the balloon catheter 31 during rotation. The balloon catheter 31 can slide laterally relative to the transmission tube 6. The proximal end of the balloon catheter 31 is located outside the handle housing 1 and is equipped with an operating connector 33. The drug-eluting balloon body 32 is fixedly installed at the distal end of the balloon catheter 31 and is fitted within the grinding head assembly 2. The drug-eluting balloon body 32 is made of a biocompatible elastic material and wraps around the balloon catheter 31. The outer wall of the drug-eluting balloon body 32 is pre-coated with medication. The operating connector 33 is used to control the expansion or contraction of the drug-eluting balloon body 32. It should be noted that the drug balloon 32 may also have circumferentially spirally distributed expansion grooves, which facilitates control of the expansion angle when the drug balloon 32 is filled and expanded, and prevents the drug balloon from shifting during the expansion process.

[0029] In some specific implementations of this embodiment, refer to Figure 2 As shown, the operating connector 33 can be Y-shaped and is provided with a guidewire port 34 and a liquid port 35. The balloon catheter 31 has a liquid passage chamber 36 and a guidewire chamber 37, and the liquid passage chamber 36 is connected to the liquid port 35. The drug balloon body 32 is connected to the liquid passage chamber 36, and the guidewire chamber 37 is connected to the guidewire port 34. The liquid port 35 is convenient to connect to an external syringe or pump, so that liquid can be introduced into the drug balloon body 32 through the liquid passage chamber 36 of the balloon catheter 31 for expansion or liquid can be aspirated for contraction. The guidewire chamber 37 can be used to insert a guidewire for guidance and control.

[0030] Example 3

[0031] Based on Example 2, and referring to Figure 5As shown, the grinding head assembly 2 includes two semi-grinding head housings 23, which are symmetrically distributed and can be assembled into a complete spindle-shaped grinding head. One semi-grinding head housing 23 is fixedly connected to the transmission tube 6, and the other semi-grinding head housing 23 is slidably sleeved on the distal end of the balloon catheter 31. Specifically, the distal end of the balloon catheter 31 extends beyond the drug balloon 32 by a certain length, and the semi-grinding head housing 23 is slidably sleeved on the extended section of the balloon catheter 31. A stop block can be provided at the distal end of the balloon catheter 31 to prevent the semi-grinding head housing 23 from completely falling off. Both semi-grinding head housings 23 have through holes through which the uninflated drug balloon 32 can pass. This allows the drug balloon 32 to fit between the two semi-grinding head housings 23. The semi-grinding head housing 23 connected to the transmission tube 6 is equipped with an electromagnet, specifically configured such that multiple [electromagnetic elements] can be formed on the inner wall of the semi-grinding head housing 23. The annular groove allows the enameled wire to be distributed in concentric circles along the groove, forming multiple electromagnetic coils. The coils are then sealed with adhesive. The half-grinding head housing 23 is made of an easily magnetizable metal material. A conductive slip ring, electrically connected to the electromagnetic coils, is installed on the transmission tube 6. The conductive wire can be distributed along the side wall of the transmission tube 6. A brush, in contact with the conductive slip ring, is installed inside the handle housing 1. A control switch controlling the current direction is also installed on the handle housing 1. This allows control of the magnetic pole changes by controlling the current direction of the electromagnetic coils embedded in the half-grinding head housing 23. A fixed magnet, i.e., a permanent magnet, is installed on the other half-grinding head housing 23, specifically fixed at the inner edge of the mating end. This allows the magnetic poles of the half-grinding head housing 23 on the transmission tube 6 to be changed, generating attraction or repulsion between the two half-grinding head housings 23, facilitating separation or merging.

[0032] Therefore, when the two semi-grinding head housings 23 are magnetically connected together for rotational grinding, the uninflated drug capsule 32 is located inside the semi-grinding head housing 23. After grinding is completed, the two semi-grinding head housings 23 are separated by repulsive magnetic force, which makes it easier to expose the internal drug capsule 32, and then inflate it for treatment.

[0033] In addition, to ensure that the two half-grinding head housings 23 can be effectively connected and rotated together after being joined, anti-slip textures or anti-slip shells can be provided at the joint position of the two half-grinding head housings 23 to prevent slippage during rotation.

[0034] Example 4

[0035] Based on Example 2, another implementation method is adopted, referring to... Figure 7 and Figure 8As shown, the grinding head assembly 2 includes a grinding head component 21 and a through cavity 22. The grinding head component 21 is fixedly connected to the transmission tube 6. The through cavity 22 is opened through the grinding head component 21, and the drug capsule 32 is fitted inside the through cavity 22.

[0036] When it is necessary for the drug capsule 32 to protrude from the grinding head 21, the handle housing 1 drives the grinding head 21 to move laterally relative to the drug capsule 32, so that the drug capsule 32 protrudes from the through cavity 22 relative to the grinding head 21.

[0037] Example 5

[0038] Based on Example 1, and referring to Figure 2 As shown, the drive mechanism 7 includes a drive motor 71, a drive gear 72, and a driven gear ring 73. The drive motor 71 is fixedly installed inside the handle housing 1. The drive gear 72 is coaxially fixedly connected to the main shaft end of the drive motor 71. A support sleeve 74 is rotatably installed inside the handle housing 1 and coaxially fixedly connected to the transmission tube 6. The balloon catheter 31 can pass through the center of the support sleeve 74, and there is a gap between the two without contact. When setting the support sleeve 74, a support ring can be fixedly installed inside the handle housing 1, and then the support sleeve 74 is rotatably connected to the support ring. At the same time, limit rings can be set on both sides of the support sleeve 74 to ensure that the support sleeve 74 only rotates on its own axis. The driven gear ring 73 meshes with the drive gear 72, and the driven gear ring 73 is coaxially fixedly connected to the support sleeve 74. In this way, the drive motor 71 drives the drive gear 72 to rotate, and the drive gear 72 drives the driven gear ring 73 to rotate. The driven gear ring 73 can then drive the transmission tube 6 to rotate through the support sleeve 74 to complete the rotational grinding action of the grinding head assembly 2.

[0039] In some specific embodiments of this example, a through groove 8 is provided on the handle housing 1 near the drive gear 72. A sliding button 81 is slidably connected to the through groove 8. The sliding button 81 can be slidably connected to the through groove 8 using an I-shaped slider. A locking rod 82 that cooperates with the drive gear 72 is fixedly connected to the side of the sliding button 81 near the inside of the handle housing 1. The locking rod 82 can be driven by the sliding button 81 to hold the drive gear 72, so that the grinding head assembly 2 stops quickly after the drive motor 71 stops.

[0040] It should be noted that, regardless of the type of grinding head assembly 2 mentioned above, diamond abrasive grains can be placed on its surface to improve the grinding effect.

[0041] Additionally, it should be noted that, in order to avoid the rotating driven gear ring 73 affecting the balloon catheter 31, an inner sleeve 38 can be fixedly sleeved on the outside of the balloon catheter 31, so that the inner sleeve 38 extends out from the handle housing 1 and is fixedly connected to the operating connector 33. At the same time, a certain gap is maintained between the inner sleeve 38 and the transmission tube 6, the support rotating sleeve 74 and the driven gear ring 73, so that there is no contact.

[0042] Example 6

[0043] Based on Embodiment 1, in order to facilitate the cooling of the grinding head assembly 2 during the rotary grinding process, refer to Figure 2 and Figure 4 As shown, a Luer connector 9 for connecting an external coolant delivery pump is installed on one outer wall of the handle housing 1, and an outer tube fixing seat 91 is fixedly installed inside the handle housing 1. An outer tube body 92, which is fixedly connected to the outer tube fixing seat 91, is sleeved on the outside of the transmission tube 6. There is a gap between the outer tube body 92 and the transmission tube 6, and they do not contact each other, so as to avoid the transmission tube 6 from affecting the outer tube body 92 during rotation. A fluid delivery chamber communicating with the Luer connector 9 is opened in the side wall of the outer tube body 92, and the side of the fluid delivery chamber near the grinding head assembly 2 is open, while the other side is closed. The end of the outer tube body 92 extends to a position close to the grinding head assembly 2.

[0044] During the grinding process of the grinding head assembly 2, the external coolant delivery pump can be started to deliver coolant, so that the coolant enters the delivery chamber of the outer tube 92 through the Luer connector 9, and then the coolant flows along the delivery chamber to the grinding head assembly 2 for cooling. The working cycle of the grinding head assembly 2 is 20 seconds of grinding and 20 seconds of stopping.

[0045] Example 7

[0046] Based on Embodiment 2, in order to ensure that the drug balloon mechanism 3 does not undergo relative displacement during the operation of the grinding head assembly 2; refer to Figure 2As shown, a fixing valve 10 is fixedly installed on the side of the handle housing 1 away from the grinding head assembly 2. The balloon catheter 31 passes through the fixing valve 10. It should be noted that if an inner sleeve 38 is fixedly sleeved on the outside of the balloon catheter 31, the inner sleeve 38 will also pass through the fixing valve 10. The fixing valve 10 can lock the balloon catheter 31. The fixing valve 10 is a commonly used catheter instrument accessory. The valve body has a through channel, and a threaded knob, called a locking knob, is provided at the port of the channel. The inner wall of the locking knob is a tapered slope, and an elastic sealing ring that matches the tapered slope of the locking knob is provided on the inner side of the channel. When the locking knob is loosened counterclockwise, the conical bevel has no squeezing effect on the elastic sealing ring, and the internal elastic sealing ring is in a relaxed state, which facilitates the sliding insertion of the balloon catheter 31. When the locking knob is rotated clockwise, the conical bevel exerts a squeezing effect on the elastic sealing ring, which can tighten the elastic sealing ring and lock the balloon catheter 31. Alternatively, the fixing valve 10 can be set as a sleeve that can be fixedly connected to the handle, and a fastening bolt is threaded on the side wall of the sleeve. The fastening bolt is perpendicular to the balloon catheter 31 passing through the sleeve. When it is necessary to lock the balloon catheter 31, the fastening bolt can be tightened to press and fix the balloon catheter 31. Other existing fixing mechanisms can also be used, which will not be described in detail here.

[0047] When it is necessary to expose the drug balloon 32 from the grinding head assembly 2, one hand can hold the end of the balloon catheter 31 connected to the operating connector 33 and keep it still, then unlock the fixing valve 10, and cause the handle housing 1 to move the grinding head assembly 2 back relative to the drug balloon 32, thereby exposing the drug balloon 32. Since the drug balloon 32 has not moved relative to the lesion position, it can directly fill and expand the lesion position.

[0048] To facilitate understanding of the embodiments of this solution by those skilled in the art, the working principle of this solution will now be briefly explained in conjunction with specific application scenarios: First, the guidewire is inserted into the guidewire lumen 37 of the balloon catheter 31 through the operating connector 33 and exits from the distal end of the balloon catheter 31. Then, with the assistance of relevant medical devices, the guidewire is inserted to the location of the coronary artery lesion. The entire rotational atherectomy catheter is then pushed to the lesion location along the guidewire. With the assistance of relevant medical imaging equipment, the atherectomy head assembly 2 can contact the calcified tissue of the lesion. The drug-eluting balloon body 32 is kept relatively fixed inside the atherectomy head assembly 2. At the same time, the liquid port 35 on the operating connector 33 connected to the balloon catheter 31 is connected to a liquid injector via a flexible tube.

[0049] When the grinding head assembly 2 is set up with two half-grinding head housings 23, before it is inserted into the body, the half-grinding head housing 23 connected to the transmission tube 6 is made to generate a magnetic force by controlling the switch in advance, and the magnetic poles are opposite to those of the fixed magnet on the other half-grinding head housing 23, so that the two can be magnetically attracted together. At this time, the drug capsule 32 is folded and stored inside the spliced ​​half-grinding head housing 23, and the capsule catheter 31 is fixed relative to the handle housing 1 by the fixed valve 10. For the grinding head assembly 2 using the complete grinding head part 21, the drive motor 71 can be started directly. The drive motor 71 drives the drive gear 72 to rotate, and the drive gear 72 drives the driven gear ring 73 to rotate. The driven gear ring 73 can then drive the transmission tube 6 to rotate through the support rotating sleeve 74 to complete the rotation grinding action of the grinding head assembly 2. During the grinding process, the external coolant delivery pump can be started to deliver coolant, which enters the delivery chamber of the outer tube 92 through the Luer connector 9, and then flows along the delivery chamber to the grinding head assembly 2 for cooling.

[0050] After grinding is completed, release the lock of the fixed valve 10, then hold the end of the balloon catheter 31 connected to the operating connector 33 with one hand and keep it still, while holding the handle housing 1 with the other hand to drive the grinding head assembly 2 to retract relative to the drug balloon body 32. For the grinding head assembly 2 using the complete grinding head 21, the drug balloon 32 can extend directly relative to the through cavity 22 of the grinding head 21. When the grinding head assembly 2 is set up with two half-grinding head housings 23, the direction of the electromagnetic coil current in the half-grinding head housing 23 connected by the transmission tube 6 can be reversed by the control switch, so that it is the same as the magnetic pole of the fixed magnet on the other half-grinding head housing 23, so that the two can generate a repulsive magnetic force to separate and open. Then, with the back-retraction action, the drug balloon 32 is fully exposed. Since the drug balloon 32 has not moved relative to the lesion position, liquid can be directly injected into the exposed drug balloon 32 through the pre-connected liquid syringe to make it swell and expand, so as to directly act on the lesion position. After the action is completed, the liquid can be aspirated back, so that the drug balloon 32 dries up, and then it is gradually retracted.

[0051] The above-disclosed embodiments are merely a few specific examples of the present invention. However, the embodiments of the present invention are not limited thereto, and any variations that can be conceived by those skilled in the art should fall within the protection scope of the present invention.

Claims

1. A rotablation balloon-in-bag catheter, comprising a handle housing (1) and a rotablation mechanism; the rotablation mechanism comprises a burr assembly (2) for grinding calcified tissue, characterized in that, Also include the drug balloon mechanism (3); The drug balloon mechanism (3) is matched and arranged in the inside of the grinding head assembly (2); the drug balloon mechanism (3) is connected with the grinding head assembly (2) in a separable mode, and the handle shell (1) is used for controlling the separation of the grinding head assembly (2) and the drug balloon mechanism (3).

2. The rotational atherectomy device of Claim 1, wherein the balloon is a drug- eluting balloon. The rotary grinding mechanism further comprises a transmission pipe (6), one end of the transmission pipe (6) is rotatably arranged in the handle shell (1), the other end is connected with the grinding head assembly (2), and the inside of the handle shell (1) is provided with a driving mechanism (7) for driving the transmission pipe (6) to rotate.

3. The rotational atherectomy device of Claim 2, wherein the balloon is a drug- eluting balloon. The drug balloon mechanism (3) comprises a balloon catheter (31) and a drug balloon body (32), the balloon catheter (31) penetrates through the transmission pipe (6), and there is a gap between the balloon catheter (31) and the transmission pipe (6); the proximal end of the balloon catheter (31) is provided with an operation joint (33), and the drug balloon body (32) is fixedly installed at the distal end of the balloon catheter (31), and the drug balloon body (32) is matched in the grinding head assembly (2), and the operation joint (33) is used for controlling the expansion or contraction of the drug balloon body (32).

4. The rotational atherectomy device of Claim 3, wherein the balloon is a drug- eluting balloon. The operation joint (33) is provided with a guide wire port (34) and a liquid port (35), the balloon catheter (31) is provided with a liquid cavity (36) and a guide wire cavity (37), the liquid cavity (36) is communicated with the liquid port (35), the drug balloon body (32) is communicated with the liquid cavity (36), and the guide wire cavity (37) is communicated with the guide wire port (34).

5. The rotational atherectomy device of Claim 3, wherein the balloon is a drug- eluting balloon. The grinding head assembly (2) comprises two half grinding head shells (23), and the two half grinding head shells (23) are symmetrically distributed; one of the half grinding head shells (23) is fixedly connected with the transmission pipe (6), and the other half grinding head shell (23) is slidably sleeved on the distal end of the balloon catheter (31); the half grinding head shell (23) connected with the transmission pipe (6) is provided as an electromagnet; the other half grinding head shell (23) is provided with a fixed magnet.

6. The rotational atherectomy device of Claim 3, wherein the balloon is a drug- eluting balloon. The grinding head assembly (2) comprises a grinding head (21) and a through cavity (22), the grinding head (21) is fixedly connected with the transmission pipe (6), and the through cavity (22) is provided in the grinding head (21) and matched with the drug balloon body (32).

7. The rotational atherectomy device of Claim 2, wherein the balloon is a drug- eluting balloon. The driving mechanism (7) comprises a driving motor (71), a driving gear (72) and a driven gear ring (73), the driving motor (71) is fixedly installed on the inside of the handle shell (1), the driving gear (72) is coaxially fixedly connected with the main shaft end of the driving motor (71), the inside of the handle shell (1) is rotatably provided with a supporting rotating sleeve (74) which is coaxially fixedly connected with the transmission pipe (6); the driven gear ring (73) is engaged with the driving gear (72), and the driven gear ring (73) is coaxially fixedly connected with the supporting rotating sleeve (74).

8. The rotational atherectomy device of Claim 7, wherein the balloon is a drug- eluting balloon. The handle shell (1) is provided with a through sliding groove (8) near the position of the driving gear (72), and the sliding groove (8) is slidably connected with a sliding button (81); the sliding button (81) is fixedly connected with a locking rod (82) matched with the driving gear (72) on the side close to the inside of the handle shell (1).

9. The rotational atherectomy device of Claim 2, wherein the balloon is a drug- eluting balloon. A luer joint (9) for connecting an external cooling liquid delivery pump is mounted on the side outer wall of the handle shell (1), and an outer pipe fixing seat (91) is fixedly installed in the handle shell (1), and an outer pipe body (92) fixedly connected with the outer pipe fixing seat (91) is sleeved on the transmission pipe (6); a liquid delivery cavity in communication with the luer joint (9) is formed in the side wall of the outer pipe body (92).

10. The rotational atherectomy device of Claim 3, wherein the balloon is a drug- eluting balloon. A fixed valve (10) is fixedly installed on the side of the handle shell (1) away from the grinding head assembly (2), the balloon catheter (31) penetrates through the fixed valve (10), and the fixed valve (10) is used for locking the balloon catheter (31).

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