Medical rotational atherectomy device and rotational atherectomy method

Abstract

Disclosed are a medical rotational atherectomy device and a rotational atherectomy method. The medical rotational atherectomy device comprises a rotational atherectomy assembly and an adjustment assembly. The rotational atherectomy assembly comprises a driver (1) and a grinding head (2). The grinding head (2) is in transmission connection with the driver (1). The adjustment assembly comprises a controller (3), a transmission (4), and a sensor (5). Both the sensor (5) and the transmission (4) are disposed between the driver (1) and the grinding head (2). The controller (3) is electrically connected to the driver (1), the transmission (4), and the sensor (5), and is configured to receive feedback from the sensor (5) and control the rotational speed of the driver (1) and the transmission ratio of the transmission (4) on the basis of actual conditions, so as to adjust the rotational speed and the torque of the grinding head (2). The medical rotational atherectomy device and the rotational atherectomy method enable the controller to control the rotational speed of the driver and the transmission ratio of the transmission on the basis of requirements, thereby flexibly controlling the rotational speed and the torque of the grinding head. This effectively achieves control over the torque and the rotational speed of the grinding head at different treatment stages. Meanwhile, the sensor enables real-time monitoring of the rotational speed and the torque of the grinding head, allowing for timely identification and resolution of jamming of the grinding head when jamming occurs, thereby ensuring surgical effectiveness.

Description

Medical atherectomy device and atherectomy method

[0001] Related applications

[0002] This application claims priority to Chinese patent application number 202311526178.5, filed on November 15, 2023, entitled “Medical Rotational Abrasion Device and Rotational Abrasion Method,” the entire text of which is incorporated herein by reference. Technical Field

[0003] The present application relates to the field of medical device technology, and in particular to a medical rotational atherectomy device and a rotational atherectomy method. Background Art

[0004] Currently, when performing pretreatment for atherosclerosis resection on severe calcification, the grinding head of the rotary grinding device can be driven to rotate at high speed, so that the grinding head can perform high-speed rotation and grinding at the vascular lesion site to remove calcified or fibrotic arteriosclerotic plaques, open blood vessels blocked by plaques, obtain an enlarged and smooth vascular lumen, and facilitate the subsequent implantation of stents.

[0005] To ensure effective treatment, the atherectomy device's grinding head must maintain low speed and high torque within the guide catheter during delivery and withdrawal to avoid stalling and large diameter changes that could wear the guide catheter. When atherectomizing lesions, the atherectomy device maintains high speed and low torque to produce smaller debris, preventing clogging and damage to blood vessels. In other words, the atherectomy device's grinding head has different speed and torque requirements at different stages of treatment.

[0006] However, current atherectomy devices mainly control the speed of the motor by controlling the voltage or current or the pressure of the output gas, thereby controlling the speed and torque of its grinding head. However, as the motor increases or decreases the speed of the grinding head, the torque of the grinding head will also increase or decrease accordingly. It is impossible to effectively adjust the relationship between speed and torque according to actual conditions, and it is also impossible to free the grinding head from being stuck in time when it becomes stuck, thereby affecting the surgical effect.

[0007] Summary of the Invention

[0008] Based on this, it is necessary to provide a medical atherectomy device and atherectomy method to address the above-mentioned problems of being unable to effectively adjust the relationship between speed and torque according to actual conditions, and being unable to promptly free the grinding head from being stuck when it becomes stuck, thereby affecting the surgical effect.

[0009] According to one aspect of the present application, a medical rotational atherectomy device is provided, comprising:

[0010] The atherectomy assembly comprises a driver, a flexible shaft, and a grinding head, wherein the driver is in driving connection with the proximal end of the flexible shaft, and the grinding head is disposed on the distal end of the flexible shaft;

[0011] an adjustment assembly comprising a controller, a transmission, and a sensor, wherein an input end of the transmission is in transmission connection with the driver, an output end of the transmission is in transmission connection with the proximal end of the flexible shaft, the controller is electrically connected to the driver, the transmission, and the sensor, the sensor being configured to detect the rotational speed and torque of the grinding head in real time and provide feedback to the controller, the controller being configured to receive feedback from the sensor and control the rotational speed of the driver, the transmission ratio of the transmission, and / or the direction of current delivered to the driver, so as to adjust the rotational speed, torque, and / or rotational direction of the grinding head;

[0012] The controller is further provided with preset parameters, which include a first transmission ratio of the transmission when the grinding head is delivering and exiting the catheter, and a second transmission ratio of the transmission when the grinding head is performing rotational grinding of lesions, wherein the first transmission ratio is different from the second transmission ratio.

[0013] In one embodiment, the transmission includes a driving gear, a first driven gear, and a second driven gear, wherein the driving gear is in driving connection with the driving shaft of the driver, the first driven gear and the second driven gear are both in driving connection with the flexible shaft, and the first driven gear and the second driven gear have different diameters;

[0014] The driving gear is configured to move to alternately mesh with the first driven gear and the second driven gear to change a gear ratio of the transmission.

[0015] In one embodiment, the transmission further includes a driving member, which is in transmission connection with the driving gear and is configured to drive the driving gear to move; and the controller is electrically connected to the driving member to control the movement of the driving gear.

[0016] In one embodiment, the transmission has a first gear ratio and a second gear ratio, the first gear ratio is 1:4, and the second gear ratio is 1:1.

[0017] In one embodiment, the controller stores a preset threshold value of the rotational speed of the grinding head and a preset threshold value of the torque of the grinding head. When the controller receives feedback that the real-time rotational speed of the grinding head is less than the preset threshold value of the rotational speed of the grinding head and the real-time torque of the grinding head is greater than the preset threshold value of the torque of the grinding head, the controller switches the direction of the current delivered to the driver, causing the grinding head to switch its rotation direction.

[0018] According to another aspect of the present application, a rotational atherectomy method is provided, which is applied to the above-mentioned medical rotational atherectomy device, and the method comprises the following steps:

[0019] The driver is controlled to drive the grinding head to rotate, and when the grinding head is in a first working state, the transmission ratio of the transmission is controlled to be a first transmission ratio, and when the grinding head is in a second working state, the transmission ratio of the transmission is controlled to be a second transmission ratio; wherein the first transmission ratio is different from the second transmission ratio;

[0020] Acquire detection signals of the rotation speed and torque of the grinding head in real time, and determine the state of the grinding head according to the detection signals;

[0021] When it is determined that the grinding head is in an incarcerated state, the rotation direction of the grinding head is controlled to be cyclically converted.

[0022] In one embodiment, when the grinding head is in the first working state, the transmission ratio of the transmission is controlled to be the first transmission ratio, and when the grinding head is in the second working state, the transmission ratio of the transmission is controlled to be the second transmission ratio, including:

[0023] When the grinding head performs a rotational grinding operation on a lesion, the transmission ratio of the transmission is controlled to be a first transmission ratio; when the grinding head performs a delivery and withdrawal operation on a catheter, the transmission ratio of the transmission is controlled to be a second transmission ratio; wherein the first transmission ratio is smaller than the second transmission ratio.

[0024] In one embodiment, when the burr head performs a rotational atherectomy operation, the transmission ratio of the transmission is controlled to be a first transmission ratio; when the burr head performs a delivery and withdrawal operation on a catheter, the transmission ratio of the transmission is controlled to be a second transmission ratio, including:

[0025] When the grinding head performs a rotational grinding operation on a lesion, the transmission ratio of the transmission is controlled to be 1:4; when the grinding head performs a conveying and withdrawing operation on a catheter, the transmission ratio of the transmission is controlled to be 1:1.

[0026] In one embodiment, the real-time acquisition of detection signals of the rotational speed and torque of the grinding head and the determination of the state of the grinding head according to the detection signals include:

[0027] When the real-time rotation speed of the grinding head is less than a first threshold value and the real-time torque of the grinding head is less than a second threshold value, determining that the grinding head is in a non-stuck state;

[0028] When the real-time rotation speed of the grinding head is less than the first threshold value and the real-time torque of the grinding head is greater than the second threshold value, it is determined that the grinding head is in a stuck state.

[0029] In one embodiment, when determining that the grinding head is in an incarcerated state, controlling the rotation direction of the grinding head to cyclically switch includes:

[0030] The direction of the current output to the driver is cyclically changed so that the rotation direction of the grinding head is cyclically switched between forward rotation and reverse rotation.

[0031] The above-mentioned medical atherectomy device and atherectomy method can enable the controller to control the transmission ratio of the transmission to decrease when the grinding head is conveying and exiting the catheter, so that the grinding head outputs low speed and high torque, avoiding stalling and large diameter change causing wear of the guide catheter. At the same time, the controller can control the transmission ratio of the transmission to increase when the grinding head is atherectomizing the lesion, so that the grinding head outputs high speed and low torque, thereby generating smaller grinding debris size, avoiding blockage and damage to blood vessels, and effectively realizing the control of the torque and speed of the grinding head in different treatment stages. At the same time, the speed and torque of the grinding head can be monitored in real time by the sensor, so as to timely identify when the grinding head is stuck and change the direction of the output current to continuously change the rotation direction of the grinding head, and break away from the stuck state through the vibration generated during the forward and reverse switching, thereby ensuring the surgical effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] To more clearly illustrate the technical solutions in the embodiments of this application or related technologies, the following briefly introduces the drawings required for use in the embodiments or related technology descriptions. Obviously, the drawings described below are only some embodiments of this application. For those of ordinary skill in the art, other drawings can be derived from these drawings without inventive effort.

[0033] FIG1 is a schematic block diagram of a medical rotational atherectomy device according to some embodiments of the present application.

[0034] FIG2 is a schematic diagram of the external structure of a medical rotational atherectomy device according to some embodiments of the present application.

[0035] FIG3 is a partial structural schematic diagram of a transmission of a medical rotational atherectomy device according to some embodiments of the present application.

[0036] FIG4 is a schematic diagram of another portion of the structure of a transmission of a medical rotational atherectomy device according to some embodiments of the present application.

[0037] FIG5 is a flowchart illustrating a triggering process for the incarceration process of a medical rotational atherectomy device according to some embodiments of the present application.

[0038] FIG6 is a block diagram of the recovery process of the incarceration process of the medical rotational atherectomy device according to some embodiments of the present application.

[0039] FIG. 7 is a flow chart illustrating a rotational atherectomy method applied to a medical rotational atherectomy device according to some embodiments of the present application.

[0040] Reference numerals: 1. driver; 2. grinding head; 3. controller; 4. transmission; 41. driving gear; 42. first driven gear; 43. second driven gear; 5. sensor; 6. housing. DETAILED DESCRIPTION

[0041] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0042] In the description of this application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on this application.

[0043] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, if the term "plurality" appears, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0044] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0045] In this application, unless otherwise expressly specified or limited, if a first feature is described as being "above" or "below" a second feature, or similar descriptions, this may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is described as being "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is described as being "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0046] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only embodiment.

[0047] Atherectomy is a nonsurgical procedure that uses a device attached to the end of a catheter to open blocked coronary arteries or venous grafts by cutting or shaving away atherosclerotic plaque (e.g., deposits of fat and other material that accumulate in the artery walls). For the purposes of this application, "abrasion" is used to describe the grinding and / or scraping action of the atherectomy device tip. Atherectomy is a procedure performed to restore oxygen-rich blood flow to the heart, relieve chest pain, and prevent heart attacks. Patients with chest pain that has not responded to other medications and certain patients undergoing balloon angioplasty (a procedure that uses a balloon catheter to flatten plaque in the artery wall) or coronary artery bypass graft surgery and peripheral artery therapy may undergo this procedure. Sometimes, it is necessary to remove plaque that has built up after coronary artery bypass graft surgery. Atherectomy uses a rotating scraper or other device attached to the end of a catheter to cut away or destroy plaque. At the beginning of the procedure, medication is used to control blood pressure, dilate the coronary arteries, and prevent blood clots. The patient is awake but sedated. The catheter is inserted into the aorta in the groin, leg, or arm and threaded through the blood vessel to the blocked coronary artery. The cutting head reaches the site of the plaque and activates, grinding it up or aspirating it out. There are several types of atherectomy: rotary, directional, and endovascular extraction. Rotational atherectomy uses a high-speed rotating blade to grind up the plaque. Directional atherectomy, the first type approved but no longer commonly used, scrapes the plaque into a notch on the side of the catheter. Transluminal extraction coronary atherectomy uses a device to cut the plaque from the vessel wall and vacuum it into a vial. This is used to clean out grafts. In the cardiac catheterization laboratory, atherectomy, also called coronary atherectomy, may be done instead of, or in addition to, balloon angioplasty.

[0048] Current medical rotary grinding devices can drive their grinding heads to rotate at high speed, allowing them to perform high-speed grinding at vascular lesions to remove calcified or fibrotic arteriosclerotic plaques, open blood vessels blocked by plaques, and obtain an enlarged and smooth vascular lumen. By performing pre-treatment for atherosclerosis resection on severe calcifications, subsequent stent implantation is facilitated.

[0049] Different stages of rotational atherectomy have different requirements for the speed and torque of the grinding head. When delivering and withdrawing the catheter, the grinding head needs to have a low speed and high torque, while when atherectomizing the lesion, the grinding head needs to have a high speed and low torque. Current rotational atherectomy devices usually control the speed of the electric motor or pneumatic motor by increasing or decreasing the output energy. However, this method increases or decreases the torque as the speed increases or decreases, and it is impossible to control the speed and torque simultaneously. In addition, when delivering and withdrawing the catheter, the grinding head usually adopts the method of reducing the speed to avoid grinding the guide catheter. However, when the grinding head passes through the curved part, due to the low torque, the grinding head is prone to stalling and cannot pass smoothly. Moreover, during the atherectomy process, when the grinding head is blocked, the large torque may cause the grinding head to become stuck, resulting in a prolonged operation time. In summary, there is an urgent need for a medical rotational atherectomy device that can flexibly adjust the speed and torque of the grinding head according to actual conditions and can enable the grinding head to get rid of the stuck situation in time.

[0050] As shown in Figures 1 and 2 , one embodiment of the present application provides a medical rotational atherectomy device, comprising a rotational atherectomy assembly and an adjustment assembly. The rotational atherectomy assembly is used to rotate a grinding head 2 at high speed to abrade vascular lesions for rotational atherectomy. The adjustment assembly is used to monitor the speed, torque, and rotation direction of the grinding head 2 in real time, and flexibly adjust the speed, torque, and rotation direction of the grinding head 2 according to actual conditions to ensure the effectiveness of the rotational atherectomy assembly.

[0051] In a specific configuration, the rotational atherectomy assembly includes a driver 1, a flexible shaft, and a grinding head 2. The flexible shaft has a distal end for insertion into a patient's vascular system and a proximal end, opposite the distal end, that remains outside the patient's vascular system. The driver 1 is in transmission connection with the proximal end of the flexible shaft; the grinding head 2 is disposed at the distal end of the flexible shaft. Specifically, the grinding head 2 is in transmission connection with the driver 1 via the flexible shaft. The driver 1 can drive the grinding head 2 to rotate in a first direction and a second direction opposite the first direction, enabling high-speed rotational abrasion of vascular lesions, thereby performing rotational atherectomy. In the embodiment of the present application, the driver 1 is a drive motor.

[0052] The adjustment component includes a controller 3, a transmission 4, and a sensor 5. The input end of the transmission 4 is in transmission connection with the driver 1, and the output end of the transmission 4 is in transmission connection with the proximal end of the flexible shaft; the controller 3 is electrically connected to the driver 1, the transmission 4, and the sensor 5. The sensor 5 is configured to detect the rotational speed and torque of the grinding head 2 in real time and provide feedback to the controller 3. The controller 3 is configured to receive feedback from the sensor 5 and control the rotational speed of the driver 1, the transmission ratio of the transmission 4, and / or the direction of the current delivered to the driver 1, so that the rotational speed, torque, and / or rotational direction of the grinding head 2 are adjusted. The controller 3 is also provided with preset parameters, which include a first transmission ratio of the transmission 4 when the grinding head 2 is in the stage of delivering and withdrawing the catheter, and a second transmission ratio of the transmission 4 when the grinding head 2 is performing rotational atherectomy of the lesion, wherein the first transmission ratio is different from the second transmission ratio.

[0053] Specifically, the controller 3 is electrically connected to the driver 1 through a drive cable, and the controller 3 can adjust the speed of the grinding head 2 by controlling the speed of the driver 1. The transmission 4 is arranged between the driver 1 and the grinding head 2; the controller 3 is electrically connected to the transmission 4 through a gear shift cable. The controller 3 can control the transmission 4 to adjust its transmission ratio, thereby adjusting the torque between the driver 1 and the grinding head 2. The sensor 5 is arranged between the transmission 4 and the grinding head 2, and is electrically connected to the controller 3 through a signal cable. The speed and torque of the grinding head 2 can be detected in real time through the sensor 5, and the detection results can be fed back to the controller 3 in real time. Among them, the sensor 5 of this embodiment is a torque and speed sensor, which can measure the speed and torque of the grinding head 2 in real time based on the Hall effect and magnetoelectric effect through the magnet and magnetoresistive resistor inside the sensor 5, and transmit the measurement data to the controller 3.

[0054] In one embodiment, the controller 3 also stores a preset threshold value of the rotation speed of the grinding head 2 and a preset threshold value of the torque of the grinding head 2. When the controller 3 receives feedback that the real-time rotation speed of the grinding head 2 is less than the preset threshold value of the rotation speed of the grinding head 2 and the real-time torque of the grinding head 2 is greater than the preset threshold value of the torque of the grinding head 2, the controller 3 switches the direction of the current supplied to the driver 1, so that the grinding head 2 switches its rotation direction. That is, the controller 3 is electrically connected to the driver 1 through a drive cable, and determines the rotation direction of the grinding head 2 by controlling the direction of the output current. In this way, when the rotation speed of the grinding head 2 is less than its preset threshold value and the torque is greater than its preset threshold value, it can be determined that the grinding head is stuck. At this time, the controller 3 switches the direction of the output current, causing the driver 1 to reverse, and the vibration generated during the forward and reverse switching causes the grinding head 2 to escape from the stuck state.

[0055] More specifically, in combination with Figures 5 and 6, when the medical rotational grinding device of the present application starts the treatment mode, it can first initialize the preset threshold value of the rotation speed and the preset threshold value of the torque of the grinding head 2, as well as the rotation direction of the grinding head 2, and then drive the grinding head 2 to rotate through the driver 1, so that the grinding head 2 performs high-speed rotation grinding at the vascular lesion. During the grinding process, the rotation speed and torque of the grinding head 2 are detected in real time by the sensor 5, and the detection results are transmitted to the controller 3. The information processing module in the controller 3 can process the received detection results in real time. When it is determined that the rotational speed and torque of the grinding head 2 have not reached the preset threshold value, the controller 3 can increase the rotational speed of the grinding head 2 by increasing its own output power, and adjust the torque of the grinding head 2 by adjusting the transmission ratio of the transmission 4; when it is determined that the rotational speed of the grinding head 2 has not reached the preset threshold value but the torque exceeds the preset threshold value, it is determined that the grinding head 2 is stuck. At this time, the controller 3 switches the direction of the output current and again determines whether the torque of the grinding head 2 has reached the preset threshold value; if the torque of the grinding head 2 still reaches the preset threshold value, the controller 3 switches the direction of the output current again until the torque of the grinding head 2 is less than the preset threshold value, at which time the grinding head 2 is free from the stuck state. In one embodiment, the medical atherectomy device of the present application also includes a housing 6, and the driver 1, the transmission 4 and the sensor 5 are all arranged inside the housing 6 to be accommodated and protected by the housing 6; the grinding head 2 and the controller 3 are both located outside the housing 6 for better operation.

[0056] In summary, the medical atherectomy device of the present application, when in use, can control the driver 1 via the controller 3 to rotate the grinding head 2, causing the grinding head 2 to perform high-speed rotational grinding at the vascular lesion site, thereby performing atherectomy. During the treatment process, the sensor 5 monitors the speed and torque of the grinding head 2 in real time, allowing the sensor 5 to promptly identify and change the direction of the output current when the grinding head 2 becomes stuck, causing the rotation direction of the grinding head 2 to continuously change. The vibration generated during the forward and reverse rotations allows the grinding head 2 to break free from the stuck state, thereby ensuring the surgical effect. Furthermore, during the stages of the grinding head 2 being transported and withdrawn from the catheter, the controller 3 can control the transmission 4 to reduce the transmission ratio, causing the grinding head 2 to output low speed and high torque, thereby avoiding stalling and large diameter changes that could wear the guide catheter. During the atherectomy of the lesion, the controller 3 can control the transmission 4 to increase the transmission ratio, causing the grinding head 2 to output high speed and low torque, thereby generating smaller grinding debris size, avoiding blockage and damage to the blood vessels, and effectively achieving flexible control of the torque and speed of the grinding head 2 during different treatment stages.

[0057] In one embodiment, the transmission has a first transmission ratio and a second transmission ratio, the first transmission ratio is 1:4, and the second transmission ratio is 1:1. The controller 3 can control the transmission ratio of the transmission 4 to the first transmission ratio when the grinding head 2 is rotating to grind the lesion, so that the grinding head 2 can output high speed and low torque. The controller 3 can control the transmission ratio of the transmission 4 to the second transmission ratio when the grinding head 2 moves, so that the grinding head 2 can output low speed and high torque.

[0058] Specifically, when the driver 1 selects a drive motor, its maximum speed is 50KRPM. When the grinding head 2 is grinding the lesion, the controller 3 can control the transmission ratio of the transmission 4 to be a first transmission ratio of 1:4, so that the maximum speed of the grinding head 2 is increased to 200KRPM, which is almost the same as the maximum speed that can be provided by the currently commonly used pneumatic motors, and can meet the requirements of high speed and low torque during treatment; when the grinding head 2 is conveying and withdrawing the grinding catheter, the controller 3 can control the transmission ratio of the transmission 4 to be a second transmission ratio of 1:1, so that the maximum speed of the grinding head 2 is limited to 50KRPM, and the torque of the grinding head 2 is increased to 4 times the original, meeting the requirements of low speed and high torque, and reducing damage to the catheter.

[0059] As shown in Figures 1, 3, and 4, in one embodiment, the transmission 4 includes a driving gear 41, a first driven gear 42, and a second driven gear 43. The driving gear 41 is in driving connection with the drive shaft of the driver 1; the first driven gear 42 and the second driven gear 43 are both in driving connection with the flexible shaft, and the first driven gear 42 and the second driven gear 43 have different diameters; the driving gear 41 is configured to be movable to selectively mesh with the first driven gear 42 and the second driven gear 43 to change the transmission ratio of the transmission 4.

[0060] In one embodiment, the transmission 4 further includes a driving member, which is in transmission connection with the driving gear 41 and configured to drive the driving gear 41 to move; the controller 3 is electrically connected to the driving member to control the movement of the driving gear 41 .

[0061] Specifically, the diameter of the first driven gear 42 is smaller than the diameter of the second driven gear 43. The controller 3 can control the driving gear 41 to engage with the first driven gear 42 when the grinding head 2 is rotating the lesion, so that the grinding head 2 outputs high speed and low torque; the controller 3 can control the driving gear 41 to engage with the second driven gear 43 when the grinding head 2 moves, so that the grinding head 2 outputs low speed and high torque.

[0062] More specifically, the diameter ratio between the first driven gear 42 and the second driven gear 43 is 1:4. When the driver 1 is equipped with a drive motor, its maximum speed is 50 kRPM. When the burr 2 is atherectomizing a lesion, the controller 3 can provide a signal to the driver, causing the driver to engage the driving gear 41 with the first driven gear 42, increasing the maximum speed of the burr 2 to 200 kRPM. This is nearly identical to the maximum speed of currently available pneumatic motors, meeting the high-speed, low-torque requirements of treatment. When the burr 2 is transporting and withdrawing the atherectomy catheter, the controller 3 can provide a signal to the driver to engage the driving gear 41 with the second driven gear 43, limiting the maximum speed of the burr 2 to 50 kRPM. This increases the torque of the burr 2 by four times its original value, meeting the low-speed, high-torque requirements and minimizing catheter damage.

[0063] As shown in FIG7 , an embodiment of the present application further provides a rotational atherectomy method, which is applied to the above-mentioned medical rotational atherectomy device and includes the following steps:

[0064] S101: Control the driver to drive the grinding head to rotate, and when the grinding head is in a first working state, control the transmission ratio of the transmission to be a first transmission ratio, and when the grinding head is in a second working state, control the transmission ratio of the transmission to be a second transmission ratio; wherein the first transmission ratio is different from the second transmission ratio.

[0065] Specifically, when the grinding head 2 is performing rotational grinding of the lesion, the controller 3 controls the transmission 4 to reduce the transmission ratio to the first transmission ratio; when the grinding head 2 is delivering and withdrawing from the catheter, the controller 3 controls the transmission 4 to increase the transmission ratio to the second transmission ratio; wherein the first transmission ratio is smaller than the second transmission ratio.

[0066] For example, when driver 1 uses a drive motor with a maximum speed of 50 kRPM, when burr 2 is atherectomizing a lesion, controller 3 can control transmission 4 to a first transmission ratio of 1:4, increasing the maximum speed of burr 2 to 200 kRPM. This is nearly identical to the maximum speed of currently available pneumatic motors, meeting the high-speed, low-torque requirements of treatment. When burr 2 is delivering and withdrawing a atherectomy catheter, controller 3 can control transmission 4 to a second transmission ratio of 1:1, limiting the maximum speed to 50 kRPM and increasing the torque of burr 2 to four times its original value, meeting the low-speed, high-torque requirements and minimizing catheter damage.

[0067] S102: Acquire detection signals of the rotation speed and torque of the grinding head in real time, and determine the state of the grinding head according to the detection signals.

[0068] Specifically, the drive sensor 5 detects the rotation speed and torque of the grinding head 2 in real time. For example, the sensor 5 uses the Hall effect and magnetoelectric effect to measure the rotation speed and torque of the grinding head 2 in real time through its internal magnet and magnetoresistor, and transmits the measured data to the controller 3.

[0069] S103: When it is determined that the grinding head is in the stuck state, the rotation direction of the grinding head is controlled to be cyclically switched.

[0070] Specifically, the drive controller 3 receives the detection signal from the sensor 5 and determines the state of the grinding head 2 based on the detection signal. When it is determined that the grinding head 2 is in the stuck state, it controls the rotation direction of the grinding head 2 to cyclically switch. More specifically, the information processing module within the drive controller 3 processes the detection information transmitted by the sensor 5 in real time, compares the real-time rotation speed of the grinding head 2 with a first threshold, and compares the real-time torque of the grinding head 2 with a second threshold.

[0071] When the controller 3 determines that the real-time rotational speed of the grinding head 2 is less than the first threshold, it determines that the grinding head 2 is in a non-stuck state. At this time, the controller 3 can increase or decrease the rotational speed of the grinding head 2 by increasing or decreasing its own output power, or it can control the transmission ratio of the transmission 4 to increase or decrease the torque of the grinding head 2.

[0072] When the controller 3 determines that the real-time rotational speed of the grinding head 2 is less than the first threshold value and the real-time torque of the grinding head 2 is less than the second threshold value, the controller 3 determines that the grinding head 2 is in a non-stuck state. At this time, the controller 3 can increase the rotational speed of the grinding head 2 by increasing its own output power, or control the transmission ratio of the transmission 4 to increase or decrease the torque of the grinding head 2.

[0073] If the controller 3 determines that the real-time rotational speed of the grinding head 2 is less than a first threshold and the real-time torque of the grinding head 2 is greater than a second threshold, it determines that the grinding head 2 is in a stuck state. At this time, the controller 3 can cyclically switch the direction of its output current, causing the grinding head 2 to rotate between forward and reverse directions. The vibration generated by the forward and reverse switching can be used to release the grinding head 2 from the stuck state. The first and second thresholds are preset thresholds manually set before use.

[0074] It is worth mentioning that when the controller 3 cyclically changes the direction of its output current to make the grinding head 2 cyclically switch between forward rotation and reverse rotation, it can synchronously receive the detection information transmitted by the sensor 5 and process the detection information in real time through the information processing module. When it is determined that the real-time torque of the grinding head 2 is less than the second threshold, the controller 3 can promptly determine that the grinding head 2 has escaped the stuck state and stop changing the direction of its output current, so that the grinding head 2 stops switching between forward and reverse rotation.

[0075] 1 , 3 and 4 , in one embodiment, when the grinding head 2 is in the first working state, the step of controlling the transmission 4 to have a first transmission ratio, and when the grinding head 2 is in the second working state, the step of controlling the transmission 4 to have a second transmission ratio further includes: when the grinding head 2 performs rotational grinding of the lesion, the controller 3 controls the driving gear 41 of the transmission 4 to engage with the first driven gear 42, and when the grinding head 2 performs delivery and withdrawal from the catheter, the controller 3 controls the driving gear 41 of the transmission 4 to engage with the second driven gear 43; wherein the transmission 4 includes a driving member, a driving gear 41, a first driven gear 42 and a second driven gear 43; the driving member is in transmission connection with the driving gear 41, and the driving member is configured to drive the driving gear 41 to move; the controller 3 is electrically connected to the driving member to control the movement of the driving gear 41 so that the driving gear 41 can move to selectively engage with the first driven gear 42 and the second driven gear 43, so that the transmission ratio of the transmission 4 changes.

[0076] Specifically, the diameter of the first driven gear 42 is smaller than the diameter of the second driven gear 43. The controller 3 can control the driving gear 41 to engage with the first driven gear 42 when the grinding head 2 is rotating the lesion, so that the grinding head 2 outputs high speed and low torque; the controller 3 can control the driving gear 41 to engage with the second driven gear 43 when the grinding head 2 moves, so that the grinding head 2 outputs low speed and high torque.

[0077] In one embodiment, the diameter ratio between the first driven gear 42 and the second driven gear 43 is 1:4. When the driver 1 is a drive motor, its maximum speed is 50 kRPM. When the burr 2 is atherectomizing a lesion, the controller 3 can provide a signal to the driver, causing the driver to engage the driving gear 41 with the first driven gear 42, increasing the maximum speed of the burr 2 to 200 kRPM. This is nearly the same as the maximum speed of currently used pneumatic motors, meeting the high speed, low torque requirements of treatment. When the burr 2 is transporting and withdrawing the atherectomy catheter, the controller 3 can provide a signal to the driver, causing the driver to engage the driving gear 41 with the second driven gear 43, limiting the maximum speed of the burr 2 to 50 kRPM and increasing the torque of the burr 2 to four times its original value, meeting the low speed, high torque requirements and minimizing damage to the catheter.

[0078] When the atherectomy method of the present application is applied to the above-mentioned medical atherectomy device, the controller 3 can be driven to control the transmission ratio of the transmission 4 to decrease during the stage when the grinding head 2 is conveying and exiting the catheter, so that the grinding head 2 outputs low speed and high torque, avoiding stalling and large diameter change causing wear of the guide catheter. At the same time, the controller 3 can control the transmission ratio of the transmission 4 to increase when the grinding head 2 is atherectomizing the lesion, so that the grinding head 2 outputs high speed and low torque, thereby generating smaller grinding debris size, avoiding blockage and damage to blood vessels, thereby effectively realizing the control of the torque and speed of the grinding head 2 at different treatment stages. At the same time, the speed and torque of the grinding head 2 can be monitored in real time by the sensor 5, so as to timely identify when the grinding head 2 is stuck and change the direction of the output current to continuously change the rotation direction of the grinding head 2, and break away from the stuck state through the vibration generated during the forward and reverse switching, thereby ensuring the surgical effect.

[0079] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0080] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A medical atherectomy device, include: The atherectomy assembly comprises a driver, a flexible shaft and a grinding head, wherein the driver is in driving connection with the proximal end of the flexible shaft, and the grinding head is arranged on the distal end of the flexible shaft; A regulating component, comprising a controller, a transmission and a sensor, wherein the input end of the transmission is transmission-connected to the driver, the output end of the transmission is transmission-connected to the proximal end of the flexible shaft, the controller is electrically connected to the driver, the transmission and the sensor, the sensor is configured to detect the rotation speed and torque of the grinding head in real time and provide feedback to the controller, and the controller is configured to receive the feedback from the sensor and control the rotation speed of the driver, the transmission ratio of the transmission and / or the direction of the current delivered to the driver, so as to adjust the rotation speed, torque and / or rotation direction of the grinding head; The controller is also provided with preset parameters, which include a first transmission ratio of the transmission when the grinding head is in the stage of conveying and withdrawing from the catheter, and a second transmission ratio of the transmission when the grinding head is performing rotational grinding of lesions, and the second transmission ratio is different from the first transmission ratio.

2. The medical atherectomy device according to claim 1, wherein the transmission comprises a driving gear, a first driven gear and a second driven gear, the driving gear is drivingly connected to the driving shaft of the driver, the first driven gear and the second driven gear are both drivingly connected to the flexible shaft, and the first driven gear and the second driven gear have different diameters; The driving gear is configured to move to mesh with either the first driven gear or the second driven gear to change a gear ratio of the transmission.

3. The medical atherectomy device according to claim 2, wherein the transmission further comprises a driving member, the driving member is transmission-connected to the driving gear, and the driving member is configured to drive the driving gear to move; and the controller is electrically connected to the driving member to control the movement of the driving gear. 4 . The medical rotational atherectomy device according to claim 1 , wherein the first transmission ratio is 1:4, and the second transmission ratio is 1:

1.

5. The medical rotational atherectomy device according to claim 1, wherein the controller stores a preset threshold value of the rotation speed of the grinding head and a preset threshold value of the torque of the grinding head, and when the controller receives feedback that the real-time rotation speed of the grinding head is less than the preset threshold value of the rotation speed of the grinding head and the real-time torque of the grinding head is greater than the preset threshold value of the torque of the grinding head, the controller switches the direction of the current delivered to the driver to cause the grinding head to switch the rotation direction.

6. A rotational atherectomy method, applied to the medical rotational atherectomy device according to any one of claims 1 to 5, include: Control the driver to drive the grinding head to rotate, and when the grinding head is in a first working state, control the transmission ratio of the transmission to be a first transmission ratio, and when the grinding head is in a second working state, control the transmission ratio of the transmission to be a second transmission ratio, wherein the first transmission ratio is different from the second transmission ratio; Acquire the detection signals of the rotation speed and torque of the grinding head in real time, and judge the state of the grinding head according to the detection signals; When it is determined that the grinding head is in an incarcerated state, the rotation direction of the grinding head is controlled to be cyclically switched.

7. The rotational atherectomy method according to claim 6, wherein when the grinding head is in the first working state, the transmission ratio of the transmission is controlled to be the first transmission ratio, and when the grinding head is in the second working state, the transmission ratio of the transmission is controlled to be the second transmission ratio, include: When the grinding head performs a rotational grinding operation, the transmission ratio of the transmission is controlled to be a first transmission ratio; When the grinding head performs the operation of conveying and withdrawing the catheter, the transmission ratio of the transmission is controlled to be a second transmission ratio; wherein the first transmission ratio is smaller than the second transmission ratio.

8. The rotational atherectomy method according to claim 7, wherein when the grinding head performs the rotational atherectomy operation, the transmission ratio of the transmission is controlled to be a first transmission ratio ； When the grinding head performs the operation of conveying and withdrawing the catheter, controlling the transmission ratio of the transmission to be a second transmission ratio comprises: When the grinding head performs a rotational grinding operation, the transmission ratio of the transmission is controlled to be 1:4; When the grinding head performs conveying and withdrawing catheter operations, the transmission ratio of the transmission is controlled to be 1:

1.

9. The rotational atherectomy method according to claim 6, wherein the detection signals of the rotation speed and torque of the grinding head are obtained in real time, and the state of the grinding head is determined according to the detection signals, include: When the real-time rotation speed of the grinding head is less than a first threshold value, and the real-time torque of the grinding head is less than a second threshold value, determining that the grinding head is in a non-stuck state; When the real-time rotation speed of the grinding head is less than the first threshold value and the real-time torque of the grinding head is greater than the second threshold value, it is determined that the grinding head is in a stuck state.

10. The rotational atherectomy method according to claim 6, wherein when it is determined that the grinding head is in an incarcerated state, the rotation direction of the grinding head is controlled to be cyclically switched, include: The direction of the current output to the driver is cyclically changed so that the rotation direction of the grinding head is cyclically switched between forward rotation and reverse rotation.

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