Rotary grinding catheter and rotary grinding device

Abstract

The present application relates to a rotary grinding catheter (100) and a rotary grinding device. The rotary grinding catheter (100) comprises: a flexible driving shaft (110), the flexible driving shaft (110) being wound, and the flexible driving shaft (110) being provided with a cooling channel (111) for allowing a cooling liquid to flow; and a rotary grinding head (120) arranged at a far end of the flexible driving shaft (110), the rotary grinding head (120) being provided with a liquid outlet (121). The liquid outlet (121) penetrates from the middle area of the rotary grinding head (120) to an outer wall. The liquid outlet (121) is in communication with the far end of the flexible driving shaft (110), so that the cooling liquid passes through the cooling channel (111) and enters the liquid outlet (121). The flexible driving shaft with the cooling channel is used to convey the cooling liquid, so that the temperature generated by the friction of the flexible driving shaft can be reduced. Moreover, the cooling liquid conveyed by the flexible driving shaft is output by means of the liquid outlet, so that the cooling liquid is conveyed to an outer side of the rotary grinding head and then conveyed to a diseased site, thereby reducing the temperature rise generated when the diseased site is ground, ensuring the cooling effect, and preventing blood vessels from being damaged. Meanwhile, the generated grindings can be scoured in time, thereby preventing the blood vessels of the diseased site from being blocked by the rotary grinding head.

Description

Rotational atherectomy catheter and equipment

[0001] Related applications

[0002] This application claims priority to Chinese patent application number 202311525635.9, filed on November 15, 2023, entitled “Rotational Atherectomy Catheter and Rotational Atherectomy Device,” the entire text of which is incorporated herein by reference. Technical Field

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

[0004] With the continuous advancement of percutaneous coronary intervention (PCI), the lesions involved are becoming more numerous and complex. Coronary artery calcification has always been a challenge and a risk in interventional therapy, especially for severely calcified lesions or those with complex calcification that is tortuous, angulated, or diffuse. Correctly identifying and assessing calcified lesions and selecting appropriate interventional techniques are key to improving procedural success rates, reducing procedure-related complications, and improving both short-term and long-term patient outcomes.

[0005] The principle of rotational atherectomy is to use a rotational atherectomy device to abrade lesions at high speed, removing calcified or fibrotic arteriosclerotic plaques, opening blocked vessels, and creating a smooth vascular lumen to facilitate subsequent stent implantation. Current rotational atherectomy catheters primarily consist of a grinding head, a drive shaft, a head covered with a wear-resistant material such as diamond particles at the distal end of the drive shaft, and an outer sheath for coolant delivery. The drive shaft drives the grinding head at high speed (approximately 150,000-190,000 rpm), advancing it forward to contact and abrade the lesion.

[0006] However, during surgery, the grinding head continuously rubs against the vascular lesion, easily generating high local temperatures and friction debris. Furthermore, conventional grinding heads can easily block the vessel when contacting narrow lesions. Back-end blood flow and the delivered coolant cannot reach the contact area between the grinding head and the lesion in a timely manner, causing local temperature rise and a sudden surge of debris. This results in low cooling efficiency when the grinding head blocks the vessel, which can easily damage the vessel. Furthermore, to ensure sufficient coolant flow, the outer diameter of the sheath on the drive shaft is large, resulting in poor performance when traversing tortuous and narrow vessels.

[0007] Summary of the Invention

[0008] Based on this, it is necessary to provide a rotational grinding catheter and rotational grinding equipment to address the problems of temperature rise, poor cooling effect and poor softness that occur during the current rotational grinding catheter surgery. The rotational grinding catheter and rotational grinding equipment can reduce the temperature generated by friction and deliver coolant to the lesion site, thereby reducing the temperature rise generated when grinding the lesion site and flushing the generated grinding chips in time. At the same time, it can also make the rotational grinding catheter as a whole have a certain degree of softness, making it easier for the rotational grinding catheter to pass through tortuous blood vessels.

[0009] In a first aspect, the present application provides a rotational atherectomy catheter, comprising:

[0010] a flexible drive shaft, the flexible drive shaft being wound and having a cooling channel therein for a coolant to flow; and

[0011] The atherectomy head is arranged at the distal end of the flexible drive shaft. The atherectomy head has a liquid outlet. The liquid outlet runs through the middle area of ​​the atherectomy head to the outer wall. The liquid outlet is connected to the distal end of the flexible drive shaft, so that the coolant enters the liquid outlet through the cooling channel.

[0012] In one embodiment, the flexible drive shaft includes a flexible tube, the interior of the flexible tube penetrates from the proximal end to the distal end to form the cooling channel, and the flexible tube is spirally wound to form a hollow cylindrical shape.

[0013] In one embodiment, the liquid outlet hole is provided through the flexible tube in a radial direction.

[0014] In one embodiment, the flexible tube is wound to form a plurality of coils, and two adjacent coils are closely connected.

[0015] In one embodiment, the flexible tube is made of stainless steel.

[0016] In one embodiment, the longitudinal cross-section of the cooling channel is circular, elliptical or polygonal;

[0017] And / or, the longitudinal cross-section of the outer contour of the flexible tube is circular, elliptical or polygonal.

[0018] In one embodiment, there are multiple liquid outlet holes, and the multiple liquid outlet holes are spaced apart along the circumference of the laparoscopic head;

[0019] And / or, the plurality of liquid outlet holes are arranged in at least one row in the axial direction of the laparoscopic head.

[0020] In one embodiment, there are multiple flexible tubes, and the cooling channels of the flexible tubes are independent of each other; and the distal end of each flexible tube corresponds to at least one liquid outlet.

[0021] In one embodiment, the atherectomy head further has a liquid storage cavity, the distal ends of the plurality of flexible tubes are connected to the liquid storage cavity, and the liquid storage cavity is further connected to the plurality of liquid outlet holes.

[0022] In one embodiment, the atherectomy head is at least partially mounted on the flexible drive shaft.

[0023] In one embodiment, the atherectomy head includes a connecting portion, a first end portion and a second end portion, the first end portion is arranged on the proximal side of the connecting portion, the second end portion is arranged on the distal side of the connecting portion, the longitudinal cross-sectional area of ​​the first end portion gradually decreases from the distal end to the proximal end, the longitudinal cross-sectional area of ​​the second end portion gradually decreases from the proximal end to the distal end, and the liquid outlet is arranged on the connecting portion.

[0024] In one embodiment, the atherectomy catheter further includes a guide body, the flexible drive shaft is arranged to form a through first channel, the atherectomy head has a through second channel, the first channel and the second channel are coaxially arranged and connected, and the distal end of the guide body passes through the first channel and the second channel and extends out.

[0025] In a second aspect, the present application provides a rotational atherectomy device, comprising a drive structure, a propeller, and a rotational atherectomy catheter as described in any of the above embodiments, wherein the drive structure is connected to the proximal end of the rotational atherectomy catheter and drives the rotational atherectomy catheter to rotate, and the propeller is arranged at the proximal end of the rotational atherectomy catheter and pushes the rotational atherectomy catheter to move in the blood vessel.

[0026] After adopting the above technical solution, this application has at least the following technical effects:

[0027] The present invention relates to a atherectomy catheter and atherectomy device. In the atherectomy catheter, a atherectomy head is disposed on a flexible drive shaft, which is wound into a hollow structure. The flexible drive shaft has a cooling channel in which a coolant can flow. The atherectomy head has a liquid outlet, which can extend from the middle region of the atherectomy head to the outer wall. After the atherectomy head is disposed on the flexible drive shaft, the distal end of the flexible tube can be connected to an end of the liquid outlet located inside the atherectomy head, so that the cooling channel is connected to the liquid outlet. In this way, the coolant in the cooling channel can enter the liquid outlet and then flow through the liquid outlet to the outside of the atherectomy head to cool the atherectomy head.

[0028] This atherectomy catheter utilizes a flexible drive shaft with cooling channels to deliver coolant, reducing the temperature generated by friction of the flexible drive shaft. Furthermore, the coolant delivered by the flexible drive shaft is discharged through a liquid outlet, conveying the coolant to the outside of the atherectomy head and, in turn, to the lesion site, thereby reducing the temperature rise generated during abrasion, ensuring effective cooling and preventing damage to blood vessels. Furthermore, the atherectomy catheter can promptly flush out generated debris, preventing the atherectomy head from blocking the blood vessels at the lesion site and causing excessive debris retention, leading to complications such as slow blood flow and no reflow. Furthermore, the flexible drive shaft can directly deliver coolant, eliminating the need for an external sheath. Furthermore, the flexible drive shaft's flexibility ensures the overall flexibility of the atherectomy catheter, facilitating its passage through tortuous blood vessels. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] 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.

[0030] FIG1 is a schematic diagram of a rotational atherectomy catheter according to an embodiment of the present application.

[0031] FIG. 2 is a schematic diagram of the flexible drive shaft in the rotational atherectomy catheter shown in FIG. 1 .

[0032] FIG3 is a schematic diagram of installing a guide body in the rotational atherectomy catheter shown in FIG1 .

[0033] FIG. 4 is a schematic diagram of the rotational atherectomy catheter shown in FIG. 1 being applied to a rotational atherectomy device.

[0034] Among them: 100, atherectomy catheter; 110, flexible drive shaft; 111, cooling channel; 112, flexible tube; 120, atherectomy head; 121, liquid outlet; 113, first channel; 122, first end; 123, second end; 124, connecting part; 125, second channel; 130, guide body; 200, pusher; 210, push knob. DETAILED DESCRIPTION

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] In conjunction with Figures 1 to 3, the present application provides a rotational atherectomy catheter 100. The rotational atherectomy catheter 100 is used in a rotational atherectomy device (as shown in Figure 4) to perform high-speed rotational grinding on the diseased part of the blood vessel to remove the diseased part (such as calcified or fibrotic arteriosclerotic plaques, etc.), open the blood vessels blocked by plaques, obtain a smooth blood vessel lumen, and facilitate the subsequent implantation of implants such as stents. Figure 1 is a schematic diagram of a rotational atherectomy catheter 100 according to an embodiment of the present application, Figure 2 is a schematic diagram of a flexible drive shaft 110 in the rotational atherectomy catheter 100 shown in Figure 1, Figure 3 is a schematic diagram of the guide body 130 installed in the rotational atherectomy catheter 100 shown in Figure 1, and Figure 4 is a schematic diagram of the rotational atherectomy catheter 100 shown in Figure 1 applied to the rotational atherectomy device. During the operation, the delivery catheter of the rotational atherectomy device cooperates to deliver the distal end of the rotational atherectomy catheter 100 to the target position, and then the drive structure controls the rotational atherectomy catheter 100 to rotate at high speed to grind the diseased part to achieve the purpose of opening the blood vessel. It is worth noting that the blood vessels that can be opened using the rotational atherectomy catheter 100 include coronary vessels, peripheral blood vessels, or other blood vessels.

[0042] Understandably, during current atherectomy catheter procedures, the grinding head continuously rubs against the vascular lesion, easily generating high local temperatures and friction debris. Furthermore, conventional grinding heads, when in contact with narrow lesions, can easily block the blood vessels. The rear-end blood flow and the delivered coolant cannot reach the contact area between the grinding head and the lesion in a timely manner, causing local temperature rise and a large amount of instantaneous debris. This results in low cooling efficiency when the grinding head blocks the blood vessel, which can easily damage the blood vessel. Therefore, the present application provides a novel atherectomy catheter 100 that can reduce the temperature generated by friction and deliver coolant to the lesion site, thereby reducing the temperature rise generated when grinding the lesion site and promptly flushing away the generated wear debris. Furthermore, the atherectomy catheter 100 can also have a certain degree of overall flexibility, facilitating its passage through tortuous blood vessels. The following describes the specific structure of the atherectomy catheter 100 according to one embodiment.

[0043] As shown in Figures 1 to 3 , in one embodiment, a rotational atherectomy catheter 100 includes a flexible drive shaft 110 and a rotational atherectomy head 120. The flexible drive shaft 110 is arranged in a coiled configuration and has a cooling channel 111 therein for coolant flow. The rotational atherectomy head 120 is disposed at the distal end of the flexible drive shaft 110 and has a liquid outlet 121 extending from a central region to an outer wall of the rotational atherectomy head 120. The liquid outlet 121 is in communication with the distal end of the flexible drive shaft 110, allowing coolant to enter the liquid outlet 121 through the cooling channel 111.

[0044] The flexible drive shaft 110 extends in an axial direction and has a proximal end and a distal end that are relatively arranged. The proximal end refers to the end of the flexible drive shaft 110 that is close to the operator; the distal end refers to the end of the flexible drive shaft 110 that is away from the operator. The flexible drive shaft 110 extends from the proximal end to the distal end and is used to transmit power. In addition, the flexible drive shaft 110 has a certain degree of flexibility. The flexible drive shaft 110 can bend due to its own flexibility so that the flexible drive shaft 110 can fit the blood vessel, facilitating the delivery of the atherectomy catheter 100 in the blood vessel. When encountering a tortuous blood vessel, the flexible drive shaft 110 can pass through smoothly due to its own flexibility.

[0045] The flexible drive shaft 110 is connected to the drive structure of the rotational atherectomy device. The drive structure serves as the power source for the rotational atherectomy catheter 100 and is capable of driving the rotational atherectomy catheter 100 to rotate. The atherectomy head 120, the main component for rotary grinding, is located at the proximal end of the flexible drive shaft 110. When the drive structure moves, it drives the flexible drive shaft 110 to rotate, which in turn drives the atherectomy head 120 to rotate at high speed, enabling the atherectomy head 120 to grind the lesion at high speed to remove the lesion.

[0046] The flexible drive shaft 110 has a through cooling channel 111; the middle part of the pulverizing head 120 has a through liquid outlet 121. One end of the liquid outlet 121 is located in the middle area of ​​the pulverizing head 120, and the other end of the liquid outlet 121 is connected to the outer wall of the pulverizing head 120. After the pulverizing head 120 is installed on the flexible drive shaft 110, the distal end of the flexible drive shaft 110 is connected to the liquid outlet 121, and then the cooling channel 111 is connected to the liquid outlet 121. The distal end of the flexible drive shaft 110 is also connected to the delivery channel of the coolant, so that the cooling channel 111 is connected to the delivery channel. It is worth noting that the delivery channel here can be a delivery channel of the delivery sheath, or a delivery channel of an external cold source, etc., and the following text will only use the delivery channel to deliver coolant as an example for explanation.

[0047] In this way, the coolant delivered by the delivery channel enters the cooling channel 111 and is then delivered to the outside of the atherectomy head 120 through the outlet hole 121. During the surgical procedure, the atherectomy head 120 rotates and grinds the lesion, which generates a temperature rise. After being delivered through the outlet hole 121, the coolant can flow to the outer wall of the atherectomy head 120 and the lesion, cooling both the atherectomy head 120 and the lesion, thereby reducing the temperature rise of the lesion during grinding.

[0048] At the same time, as the atherectomy head 120 rotates and grinds the lesion, a large amount of grinding debris is instantly generated. After the coolant is delivered through the liquid outlet 121, it flushes away the grinding debris, preventing the grinding head 120 and the grinding debris from blocking blood vessels and causing debris to accumulate. This ensures smooth blood flow and avoids complications such as slow blood flow and no blood flow. Furthermore, while the coolant flushes away the grinding debris and prevents blockage, it also ensures the flow of the coolant, further improving the cooling effect.

[0049] The atherectomy catheter 100 of the above-described embodiment utilizes a flexible drive shaft with a cooling channel 111 to deliver coolant, thereby reducing the temperature generated by friction of the flexible drive shaft 110. Furthermore, the coolant delivered by the flexible drive shaft 110 is output through a liquid outlet 121, conveying the coolant to the outside of the atherectomy head 120 and, in turn, to the lesion site, thereby reducing the temperature rise generated during abrasion of the lesion site, ensuring a cooling effect and avoiding damage to blood vessels. Furthermore, the coolant can be promptly flushed away, preventing the atherectomy head 120 from blocking the blood vessels at the lesion site, causing excessive debris retention and leading to complications such as slow blood flow and no reflow. Furthermore, the flexible drive shaft 110 can directly deliver coolant, eliminating the need for an external sheath. Furthermore, the flexible drive shaft 110 has a certain degree of flexibility, ensuring that the atherectomy catheter 100 as a whole has a certain degree of softness, facilitating passage through tortuous blood vessels.

[0050] As shown in Figures 1 to 3 , in one embodiment, the flexible drive shaft 110 further includes a flexible tube 112. The interior of the flexible tube 112 extends from the proximal end to the distal end to form a cooling channel 111. The flexible tube 112 is helically wound to form a hollow cylindrical structure. The flexible tube 112 is helically wound into a coil structure, forming a cylindrical structure with a hollow space along the axial direction. This hollow space forms the first channel 113. This facilitates the passage of the guide body 130 (described later).

[0051] Flexible tube 112 is a hollow tube. Its internal cavity extends from the proximal end to the distal end, forming cooling channel 111. Flexible tube 112 is spirally wound to form a spiral cooling channel. The proximal end of flexible tube 112 is connected to the delivery channel, while the distal end of flexible tube 112 is connected to the liquid outlet 121. This connects cooling channel 111 with the delivery channel and liquid outlet 121, allowing coolant to flow from the delivery channel through the cooling channel and out through liquid outlet 121.

[0052] In one embodiment, the flexible tube 112 is wound to form multiple coils, with adjacent coils tightly connected. The cooling channels 111 of each flexible tube 112 are independent of each other. In other words, after spirally winding, the flexible tube 112 takes on a spring-like shape, comprising multiple coils arranged at an angle. Furthermore, the tightly connected adjacent coils ensure that the flexible tube 112 forms a single unit, maintaining a certain structural strength and torque control performance, enabling the flexible tube 112 to drive the atherectomy head 120 to rotate at high speeds.

[0053] Optionally, there are multiple flexible tubes 112, which are wound side by side to form a hollow cylindrical shape. That is, after the multiple flexible tubes 112 are arranged in a row, they are spirally wound. In this way, two adjacent coils do not belong to the same flexible tube 112. The cooling channels 111 of each flexible tube 112 are independent and disconnected from each other. Each flexible tube 112 can independently transport coolant through the cooling channels 111, thereby increasing the coolant delivery speed and thus improving cooling efficiency. Exemplarily, there are three flexible tubes 112, which are spirally wound to form the flexible drive shaft 110.

[0054] In one embodiment, the flexible tube 112 is made of stainless steel. This ensures that the flexible tube 112 has a certain structural strength to drive the rotational atherectomy head 120 while also being able to transport coolant. Alternatively, the flexible tube 112 may be a hollow wire wrap or a radial spring with cooling channels 111. Of course, in other embodiments of the present application, the flexible tube 112 may also have other structural forms that are flexible and capable of transporting coolant.

[0055] In one embodiment, the longitudinal cross-section of the cooling channel 111 is circular, elliptical, or polygonal. In this embodiment, the longitudinal cross-section of the cooling channel 111 is circular to facilitate the flow of the coolant. Of course, in other embodiments of the present application, the longitudinal cross-section of the cooling channel 111 may also be elliptical, polygonal, or other irregular shapes.

[0056] In one embodiment, the longitudinal cross-section of the outer contour of the flexible tube 112 is circular, elliptical, or polygonal. This ensures that the flexible tube 112 securely fits after winding. In this embodiment, the longitudinal cross-section of the outer contour of the flexible tube 112 is circular. Of course, in other embodiments of the present application, the shape of the flexible tube 112 may also be elliptical, polygonal, or other irregular shapes.

[0057] In one embodiment, the liquid outlet 121 is provided along the radial direction of the flexible tube 112. This shortens the length of the coolant flow channel and facilitates coolant delivery. Of course, in other embodiments of the present application, the liquid outlet 121 can also be provided at an angle.

[0058] As shown in conjunction with Figures 1 and 3 , in one embodiment, a plurality of liquid outlet holes 121 are provided, and the plurality of liquid outlet holes 121 are spaced apart along the circumference of the atherectomy head 120. In other words, the plurality of liquid outlet holes 121 are spaced apart along the circumference of the atherectomy head 120. This allows the coolant to flow through the plurality of liquid outlet holes 121 to the outside of the atherectomy head 120, allowing the coolant to simultaneously contact the atherectomy head 120 and the lesion at different angles, thereby improving cooling efficiency.

[0059] In one embodiment, the plurality of liquid outlet holes 121 are arranged in at least one row in the axial direction. As shown in Figures 1 and 3, the liquid outlet holes 121 are arranged in a row, that is, a row includes multiple liquid outlet holes 121. Of course, in other embodiments of the present application, the plurality of liquid outlet holes 121 may be arranged in at least two rows in the axial direction to increase the flow rate of the coolant.

[0060] In other embodiments of the present application, the longitudinal cross-section of the cooling channel 111 is circular, elliptical, or polygonal, and the longitudinal cross-section of the outer contour of the flexible tube 112 is circular, elliptical, or polygonal. In other embodiments of the present application, the plurality of liquid outlets 121 are spaced apart along the circumference of the atherectomy head 120 and are also arranged in at least one row along the axial direction of the atherectomy head 120.

[0061] In one embodiment, the distal end of each flexible tube 112 corresponds to at least one liquid outlet. In other words, the number of flexible tubes 112 matches the number of liquid outlet holes 121 , and one flexible tube 112 can correspond to one liquid outlet hole 121 or one flexible tube 112 can correspond to two liquid outlet holes 121 .

[0062] Of course, in other embodiments of the present application, the rotational atherectomy head 120 further comprises a liquid reservoir, the distal ends of the multiple flexible tubes 112 being connected to the liquid reservoir, which in turn is connected to the multiple liquid outlets 121. In other words, the rotational atherectomy head 120 comprises a liquid reservoir internally, which connects the flexible tubes 112 and the liquid outlets 121. In this manner, coolant can flow through the flexible tubes 112 into the liquid reservoir, and then into the liquid outlets 121 through the liquid reservoir.

[0063] Optionally, the atherectomy head 120 is hollow, and its internal space is the liquid storage cavity. Of course, in other embodiments of the present application, the atherectomy head 120 may also have a ring-shaped, polygonal or other shaped space inside, which is the liquid storage cavity.

[0064] In one embodiment, the atherectomy head 120 is at least partially loaded onto the flexible drive shaft 110. In other words, the atherectomy head 120 is partially loaded onto the proximal end of the flexible drive shaft 110, as shown in FIG3 . Of course, in other embodiments of the present application, the atherectomy head 120 can also be completely loaded onto the proximal end of the flexible drive shaft 110.

[0065] As shown in conjunction with Figures 1 and 3 , in one embodiment, the atherectomy head 120 includes a connecting portion 124, a first end 122, and a second end 123. The first end 122 is disposed on the proximal side of the connecting portion 124, and the second end 123 is disposed on the distal side of the connecting portion 124. The longitudinal cross-sectional area of ​​the first end 122 gradually decreases from the distal end to the proximal end, while the longitudinal cross-sectional area of ​​the second end 123 gradually decreases from the proximal end to the distal end. The liquid outlet 121 is disposed on the connecting portion 124.

[0066] That is to say, the diameter of the atherectomy head 120 gradually decreases axially toward the distal end, and also gradually decreases axially toward the proximal end, forming a structure that is larger in the middle and smaller at both ends. For example, the atherectomy head 120 has a spindle-like structure. The liquid outlet 121 is provided at the connecting portion 124 between the first end 122 and the second end 123, and the liquid outlet 121 is located in the middle area of ​​the atherectomy head 120. After the coolant flows out through the liquid outlet 121, it can move to both sides to cool the first end 122 and the second end 123 to ensure a cooling effect. Optionally, the connecting portion 124, the first end 122 and the second end 123 are an integrated structure.

[0067] In one embodiment, the atherectomy catheter 100 may further include a guide body 130, the flexible drive shaft 110 forms a through first channel 113; the atherectomy head 120 has a through second channel 125; the first channel 113 and the second channel 125 are coaxially arranged and connected; the distal end of the guide body 130 passes through the first channel 113 and the second channel 125 and extends out.

[0068] The hollow structure formed by the spiral winding of the flexible tube 112 forms a first channel 113. The distal end of the guide body 130 extends into the first channel 113 of the flexible drive shaft 110 and then extends through the second channel 125 of the atherectomy head 120. Thus, the proximal end of the guide body 130 is located outside the flexible drive shaft 110, and the distal end of the guide body 130 is located outside the atherectomy head 120. The guide body 130 is used to guide the atherectomy head 120 to the lesion site.

[0069] During surgery using the atherectomy catheter 100 of the present application, the guide body 130 is pushed through the blood vessel via the delivery catheter, causing the atherectomy head 120 and the flexible drive shaft 110 to move within the blood vessel until the distal end of the guide body 130 reaches the target position. At this point, the atherectomy head 120 is directly facing the lesion. Subsequently, the delivery channel delivers coolant to the flexible tube 112, and the drive mechanism drives the flexible drive shaft 110 to cause the atherectomy head 120 to rotate at high speed. At this point, the atherectomy head 120 can perform high-speed rotational grinding on the lesion. Simultaneously, the coolant cools the atherectomy head 120 and the lesion, thereby cooling the high-speed grinding process. Furthermore, the coolant flushes away wear debris, preventing blood vessel blockage.

[0070] The atherectomy catheter 100 of the present application uses a flexible drive having a cooling channel 111 to deliver coolant, which can reduce the temperature generated by the friction of the flexible drive shaft 110. Moreover, the coolant delivered by the flexible drive shaft 110 is output through the liquid outlet 121 to convey the coolant to the outside of the atherectomy head 120, and then deliver the coolant to the lesion site, thereby reducing the temperature rise generated when grinding the lesion site, ensuring the cooling effect, and avoiding damage to blood vessels. At the same time, it can also promptly flush out the generated grinding debris, avoiding the atherectomy head 120 blocking the blood vessels in the lesion site, causing excessive grinding debris retention and leading to complications such as slow blood flow and no reflow. In addition, the flexible drive shaft 110 can directly deliver coolant without the need for an external sheath, and the flexible drive shaft 110 has a certain degree of flexibility, which can ensure that the atherectomy catheter 100 as a whole has a certain degree of softness, making it easier for the atherectomy catheter 100 to pass through tortuous blood vessels.

[0071] In conjunction with Figures 1 to 4 , the present application further provides a rotational atherectomy device, comprising a drive structure, a propeller 200, and a rotational atherectomy catheter 100 as described in any of the above embodiments. The drive structure is connected to the proximal end of the rotational atherectomy catheter 100 and drives the rotational atherectomy catheter 100 to rotate. The propeller 200 is disposed at the proximal end of the rotational atherectomy catheter 100 and pushes the rotational atherectomy catheter 100 to move within the blood vessel. The rotational atherectomy device pushes the rotational atherectomy catheter 100 via the propeller 200, causing the rotational atherectomy head 120 to move to the lesion site. Subsequently, the drive structure drives the rotational atherectomy catheter 100 to rotate, causing the rotational atherectomy head 120 to perform high-speed rotational grinding on the lesion site, thereby achieving the purpose of removing the lesion site.

[0072] Optionally, the pusher 200 includes a push knob 210 movably mounted on the pusher 200. Movement of the push knob 210 controls the movement of the rotational atherectomy catheter 100 within the blood vessel. The specific structure and principles of the pusher are known in the art and will not be further described here. Optionally, the rotational atherectomy device further includes a delivery sheath, through which the rotational atherectomy catheter 100 is delivered into the blood vessel.

[0073] The atherectomy device of the present application adopts the atherectomy catheter 100 of the above-mentioned embodiment, which can realize high-speed rotational grinding of the lesion site, and at the same time can also convey the coolant to the outside of the atherectomy head 120, and then deliver the coolant to the lesion site, thereby reducing the temperature rise generated when grinding the lesion site, ensuring the cooling effect, avoiding damage to blood vessels, and being able to flush out the generated grinding chips in time, avoiding the atherectomy head 120 blocking the blood vessels of the lesion site, causing excessive retention of grinding chips, leading to complications of slow blood flow and no reflow.

[0074] Optionally, the drive structure is a motor. It is understood that the centrifugal force generated by the high-speed rotation of the burr head 120 and the Bernoulli principle can increase the flow rate of the coolant. As the speed of the drive structure increases, the coolant flow rate also increases, providing a controllable flow rate. Optionally, the drive structure has multiple speed control gears, each corresponding to a coolant flow rate. This allows the appropriate speed control gear to be selected based on the desired coolant flow rate.

[0075] The atherectomy device of the present application uses the above-mentioned atherectomy catheter 100, which can use the high-speed atherectomy head 120 to grind and remove the lesion site to achieve a therapeutic effect. Specifically, the flexible drive shaft 110 can deliver coolant through the cooling channel 111 to reduce the temperature rise caused by the friction of the flexible drive shaft 110. The liquid outlet 121 on the surface of the atherectomy head 120 can also deliver coolant to the lesion site, reducing the temperature rise caused by grinding the lesion site. At the same time, it can timely flush the generated grinding debris, avoiding the complications of slow blood flow without reflow caused by excessive retention of grinding debris caused by the atherectomy head 120 blocking the blood vessels. In addition, the centrifugal force generated by the high-speed rotation of the grinding head and the Bernoulli principle can increase the flow rate of the coolant, and as the speed increases, the coolant flow rate increases, which has the advantage of controllable flow. At the same time, the atherectomy catheter 100 can avoid the problem of poor passability caused by the excessive outer diameter of the cooling sheath when using traditional catheters, making it easier to pass through tortuous blood vessels.

[0076] 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.

[0077] 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 rotational atherectomy catheter, include: A flexible drive shaft, wherein the flexible drive shaft is arranged in a winding shape and has a cooling channel for the flow of a coolant; as well as The atherectomy head is arranged at the distal end of the flexible driving shaft. The atherectomy head has a liquid outlet. The liquid outlet runs through the middle area of ​​the atherectomy head to the outer wall. The liquid outlet is connected to the distal end of the flexible driving shaft, so that the coolant enters the liquid outlet through the cooling channel.

2. The rotational atherectomy catheter according to claim 1, wherein the flexible drive shaft comprises a flexible tube, the interior of the flexible tube penetrates from the proximal end to the distal end to form the cooling channel, and the flexible tube is spirally wound to form a hollow cylinder. 3 . The rotational atherectomy catheter according to claim 2 , wherein the liquid outlet hole is disposed through the flexible tube in a radial direction.

4. The rotational atherectomy catheter according to claim 2, wherein the flexible tube is wound to form a plurality of coils, and two adjacent coils are closely connected. The rotational atherectomy catheter according to claim 2 , wherein the flexible tube is made of stainless steel.

6. The rotational atherectomy catheter according to claim 2, wherein the longitudinal cross-section of the cooling channel is circular, elliptical or polygonal; And / or, the longitudinal cross-section of the outer contour of the flexible tube is circular, elliptical or polygonal.

7. The atherectomy catheter according to claim 1, wherein the number of the liquid outlet holes is multiple, and the multiple liquid outlet holes are arranged at intervals along the circumference of the atherectomy head; And / or, the plurality of liquid outlet holes are arranged in at least one row in the axial direction of the rotational grinding head.

8. The rotational atherectomy catheter according to claim 7, wherein the number of the flexible tubes is multiple, the cooling channels of the flexible tubes are independent of each other, and the distal end of each flexible tube corresponds to at least one liquid outlet.

9. The atherectomy catheter according to claim 8, wherein the atherectomy head further comprises a liquid storage chamber, the distal ends of the plurality of flexible tubes are connected to the liquid storage chamber, and the liquid storage chamber is further connected to the plurality of liquid outlet holes.

10. The rotational atherectomy catheter of any one of claims 1 to 9, wherein the atherectomy head is at least partially carried by the flexible drive shaft.

11. A rotational atherectomy catheter according to any one of claims 1 to 9, wherein the rotational atherectomy head comprises a connecting portion, a first end and a second end, the first end is arranged on the proximal side of the connecting portion, the second end is arranged on the distal side of the connecting portion, the longitudinal cross-sectional area of ​​the first end gradually decreases from the distal end to the proximal end, the longitudinal cross-sectional area of ​​the second end gradually decreases from the proximal end to the distal end, and the liquid outlet is arranged in the connecting portion.

12. The atherectomy catheter according to any one of claims 1 to 9, wherein the atherectomy catheter further comprises a guide body, the flexible drive shaft is arranged to form a through first channel, the atherectomy head has a through second channel, the first channel is coaxially arranged and connected to the second channel, and the distal end of the guide body passes through the first channel and the second channel and extends out.

13. A rotational atherectomy device, comprising a drive structure, a propeller, and a rotational atherectomy catheter as described in any one of claims 1 to 12, wherein the drive structure is connected to the proximal end of the rotational atherectomy catheter and is used to drive the rotational atherectomy catheter to rotate, and the propeller is arranged at the proximal end of the rotational atherectomy catheter and is used to push the rotational atherectomy catheter to move in a blood vessel.

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