Rotational atherectomy system and drive handle

Abstract

This invention relates to a rotary abrasion system and its drive handle. The drive handle includes a handle housing, a drive assembly, and a telescopic guide. The drive assembly is disposed within the handle housing and is movable along the rotary abrasion guide wire. The telescopic guide is disposed along the guide wire cavity of the handle housing and forms a first guide channel. The drive shaft and the rotary abrasion guide wire are movably inserted through the first guide channel. The distal end of the first telescopic guide is connected to the handle housing. The telescopic guide is linked to the drive assembly. When the drive assembly, together with the drive shaft, moves along the rotary abrasion guide wire, the telescopic guide moves telescopically within the handle housing. The rotary abrasion system and its drive handle of this invention utilize the first guide channel of the telescopic guide to provide radial support and axial guidance for the drive shaft and rotary abrasion guide wire inserted therein. This eliminates the need for a large operating platform to maintain the axial movement guidance of structures such as rotary abrasion guide wires or rotary abrasion conduits, thereby improving the ease of operation of the drive handle.

Description

Technical Field

[0001] This invention relates to the field of interventional medical technology, and in particular to a rotary atherectomy system and its drive handle. Background Technology

[0002] Atherosclerosis is most commonly seen in the arteries of the lower extremities, characterized by the formation of fibrous and lipid plaques in the arterial intima, leading to thickening of the vessel wall and narrowing of the lumen. It is mainly distributed in the intima of the femoral-popliteal and infrakal arteries. Due to the narrowing or even blockage of the diseased arterial lumen, it causes lower extremity ischemia, gangrene, and other conditions. If left untreated, it often leads to claudication or even amputation. Atherosclerotic plaques may exhibit different characteristics depending on their texture. Currently, in medical practice, severe calcified lesions are typically pretreated using an atherectomy device. The principle of using an atherectomy device is to use a high-speed rotating abrasive device at the site of the vascular lesion to remove calcified or fibrotic atherosclerotic plaques, opening the blocked blood vessel and achieving a smoother vascular lumen, facilitating subsequent placement of drug-eluting balloons and stents. When performing interventional treatment on stenotic lesions at the opening and bifurcation of the vascular endothelium, as well as angular, eccentric, long segmental, and punctate stenotic lesions, peripheral artery plaque rotational atherosclerosis has become a commonly used clinical method for removing atherosclerotic plaques.

[0003] Current peripheral artery rotational atherectomy systems mainly consist of a control unit, a drive handle, a drive shaft, and an atherectomy head. The control unit controls the drive assembly in the drive handle to rotate the drive shaft at high speed. Moving the drive assembly back and forth allows the atherectomy head, connected to the distal end of the drive shaft, to abrade and remove lesions, breaking down plaques or calcified lesions into tiny microparticles (smaller than the diameter of a red blood cell). Peripheral artery rotational atherectomy is suitable for treating severely calcified lesions. Pre-treatment with rotational atherectomy to prepare the lumen before inserting a drug-eluting balloon or stent improves the success rate of interventional treatment while reducing the occurrence of complications.

[0004] However, in order to guide the axial movement of its internal drive components, the current drive handle has a bulky overall structure, requires a large operating platform, and is inconvenient to operate. Summary of the Invention

[0005] Based on this, a drive handle and a rotary grinding system including the drive handle are provided to solve the problem of inconvenient operation.

[0006] On one hand, embodiments of the present invention provide a drive handle, comprising:

[0007] The handle housing has a guide wire cavity that extends through the proximal and distal ends of the handle housing and is used for passing a rotary abrasion guide wire.

[0008] A drive assembly is disposed within the handle housing and is movable along the rotary polishing guide wire. The drive assembly is used to drive a drive shaft to rotate around the rotary polishing guide wire, and the drive shaft is sleeved on the rotary polishing guide wire.

[0009] A first telescopic guide is disposed along the guide wire cavity and forms a first guide channel. The drive shaft and the rotary polishing guide wire are movably inserted through the first guide channel. The distal end of the first telescopic guide is connected to the handle housing. The first telescopic guide is linked to the drive assembly. When the drive assembly and the drive shaft move along the rotary polishing guide wire, the first telescopic guide moves telescopically within the handle housing.

[0010] On the other hand, the present invention provides a rotary abrasion system, including the aforementioned drive handle, a rotary abrasion guidewire and a rotary abrasion conduit, wherein the rotary abrasion guidewire passes through the guidewire cavity and the proximal end of the rotary abrasion guidewire extends out of the proximal end of the guidewire cavity, the rotary abrasion conduit is sleeved on the rotary abrasion guidewire, and the proximal end of the rotary abrasion conduit is connected to the distal end of the drive shaft.

[0011] The present invention discloses a rotary polishing system and its drive handle. The drive handle includes a handle housing, a drive assembly, and a first telescopic guide member. The first telescopic guide member is linked to the drive assembly. When the drive assembly, together with the drive shaft, moves along the rotary polishing guide wire, the first telescopic guide member extends and retracts within the handle housing, thereby not interfering with the movement of the drive assembly along the rotary polishing guide wire. This satisfies the requirement that the drive assembly, carrying the rotary polishing guide tube, moves along the rotary polishing guide wire with sufficient stroke. Since the first guide channel of the first telescopic guide member can provide radial support and axial guidance for the drive shaft and rotary polishing guide wire and other structures passing through it, there is no need to configure a large operating platform to maintain the axial movement guidance of structures such as the rotary polishing guide wire or rotary polishing guide tube, thereby improving the ease of operation of the drive handle. Attached Figure Description

[0012] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, without paying any creative work, they can also obtain drawings of other embodiments based on these drawings.

[0013] Figure 1 A schematic diagram of the structure of a rotary milling system according to one embodiment;

[0014] Figure 2 A schematic diagram of the internal structure of the drive handle of a rotary grinding system according to one embodiment;

[0015] Figure 3A schematic diagram of the telescopic structure of the first telescopic guide and the second telescopic guide in the drive handle of the rotary grinding system according to one embodiment, during the movement of the drive assembly.

[0016] Figure 4 A schematic diagram of the telescopic guide in the drive handle of a rotary milling system according to one embodiment;

[0017] Figure 5 for Figure 4 A partially enlarged schematic diagram of part A of the telescopic guide structure is shown;

[0018] Figure 6 This is a cross-sectional schematic diagram of a portion of the drive handle of a rotary grinding system according to one embodiment.

[0019] Reference numerals: 100, Rotary grinding system; 10, Drive handle; 10a, Guide wire cavity; 11, Handle housing; 11a, First housing; 11b, Second housing; 111, First support part; 112, Second support part; 113, Third support part; 114, Fourth support part; 12, Drive assembly; 13, Telescopic guide; 13A, First telescopic guide; 13B, Second telescopic guide; 131, Sleeve; 131a, First sleeve; 131b, Second sleeve; 132, Roller; 1311, First limiting part; 1312, Second limiting part; 1313, Third limiting part; 133, Lubricating coating; 134, Fluid passage hole; 14, Wire locking assembly; 15, Track; 20, Rotary grinding guide wire; 30, Rotary grinding guide tube; 31, Rotary grinding head; 32, Drive flexible shaft. Detailed Implementation

[0020] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Preferred embodiments of the invention are shown in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

[0021] It should be noted that the terms "proximal" and "distal" are used as locative terms in the field of interventional medical devices. "Proximal" refers to the end of the device that is closer to the operator during operation, while "distal" refers to the end of the device that is farther from the operator. For example... Figure 1 In the rotary grinding system 100 shown, the left end of the drive handle 10 is the proximal end of the drive handle 10, and the right end of the drive handle 10 is the distal end of the drive handle 10.

[0022] In embodiments of the present invention, the axial direction refers to the direction parallel to the line connecting the distal center and proximal center of the medical device; the radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0023] See Figure 1 and Figure 2 As shown, the present invention provides a rotational atherectomy system 100, including a drive handle 10, a rotational atherectomy guidewire 20, and a rotational atherectomy catheter 30. The proximal ends of both the rotational atherectomy guidewire 20 and the rotational atherectomy catheter 30 are connected to the drive handle 10. The rotational atherectomy guidewire 20 serves as a structural component for establishing a pathway within the body, guiding the rotational atherectomy catheter 30 into the location within the blood vessel requiring rotational atherectomy. Specifically, the rotational atherectomy catheter 30 is fitted onto the rotational atherectomy guidewire 20 and can be rotated around and moved along the rotational atherectomy guidewire 20 by operating the drive handle 10, so that the rotational atherectomy catheter 30 performs rotational atherectomy under the guidance of the rotational atherectomy guidewire 20. It should be noted that, in the present invention, for elongated structural components, "along" refers to the movement of one structural component along another structural component, meaning the movement of one structural component along the axial direction of the other structural component. Taking the movement of the ecchymosis guide tube 30 along the ecchymosis guide wire 20 as an example, the movement of the ecchymosis guide tube 30 along the ecchymosis guide wire 20 means that the ecchymosis guide tube 30 moves along the axial direction of the ecchymosis guide wire 20.

[0024] The inventors discovered that the stroke of the rotational atherectomy catheter 30 along the axial direction of the rotational atherectomy guidewire 20 affects the effectiveness of rotational atherectomy. For example, if the stroke of the rotational atherectomy catheter 30 along the axial direction of the rotational atherectomy guidewire 20 is insufficient, when operating the drive handle 10 to control the rotational atherectomy catheter 30 for rotational atherectomy, the axial displacement of the catheter 30 along the rotational atherectomy guidewire 20 may be too small to open the diseased blood vessel. This necessitates increasing the stroke of the rotational atherectomy catheter 30 relative to the rotational atherectomy guidewire 20. However, when the drive handle 10 is equipped with a long guide rail to meet the adjustment needs of the axial movement stroke of the rotational atherectomy catheter 30, the overall structure of the drive handle 10 becomes bulky, requiring a large operating platform and resulting in poor operational convenience. Through continuous exploration, the inventors improved the structure of the drive handle 10, making it lightweight and easy to operate while still meeting the axial movement stroke of the rotational atherectomy catheter 30 along the rotational atherectomy guidewire 20.

[0025] Specifically, the drive handle 10 includes a handle housing 11, a drive assembly 12, and a telescopic guide 13. The handle housing 11 facilitates the operator's grip for rotary grinding operations. The handle housing 11 has a wire guide cavity 10a extending through the proximal and distal ends of the drive handle 10, for the passage of the rotary grinding guide wire 20. See also... Figure 1 As shown, the rotational ablation guidewire 20 is inserted into the guidewire lumen 10a, with the proximal end 20a of the rotational ablation guidewire 20 extending from the proximal end of the guidewire lumen 10a and the distal end 20b of the rotational ablation guidewire 20 extending from the distal end of the guidewire lumen 10a. Understandably, the rotational ablation guidewire 20 can be moved along the guidewire lumen 10a to insert the rotational ablation guidewire 20 into the blood vessel and guide the rotational ablation catheter 30 to move axially within the blood vessel.

[0026] The drive assembly 12 is disposed inside the handle housing 11 and is used to drive the drive shaft (not shown) to rotate around the rotatory guide wire 20. Specifically, the drive shaft is sleeved on the rotatory guide wire 20. Under the drive of the drive assembly 12, the drive shaft rotates around the rotatory guide wire 20 and drives the rotatory guide tube 30 to rotate around the rotatory guide wire 20, so as to realize the rotatory operation of the rotatory guide tube 30.

[0027] The drive assembly 12 can move along the rotational atherectomy guidewire 20 within the handle housing 11. Thus, the rotational atherectomy catheter 30 connected to the drive assembly 12 will also move along the rotational atherectomy guidewire 20 along with the drive assembly 12. When the rotational atherectomy catheter 30 grinds the atherosclerotic plaque in the diseased blood vessel, the rotational atherectomy catheter 30 can move back and forth in the blood vessel while rotating, so as to remove calcified or fibrotic atherosclerotic plaque and open the blood vessel blocked by the plaque.

[0028] The telescopic guide 13 is disposed along the guide wire cavity 10a and is linked to the drive assembly 12. When the drive assembly 12, together with the drive shaft, moves along the rotary polishing guide wire 20, the telescopic guide 13 extends and retracts within the handle housing 11. During the extension and retraction movement, the telescopic guide 13 provides support for slender elements such as the rotary polishing guide wire 20 or the rotary polishing guide tube 30 within the guide wire cavity 10a. Specifically, the telescopic guide 13 forms a guide channel, which provides radial support and axial guidance for structures inserted within it. Radial support means that it can provide support in the radial direction, thereby preventing large impacts on the structures inserted within the guide channel. Correspondingly, axial guidance means that the guide channel allows the structures inserted within it to move axially, thus providing a guiding effect for the structures inserted within it.

[0029] Because the telescopic guide 13 can extend and retract as the drive assembly 12, along with the drive shaft, moves along the rotary polishing guide wire 20, providing radial support and axial guidance for structures passing through the guide channel, the drive handle 10 does not require a large operating platform to maintain the axial movement of structures such as the rotary polishing guide wire 20 or the rotary polishing conduit 30. Furthermore, since the telescopic guide 13 can extend and retract, it does not interfere with the movement of the drive assembly 12 along the rotary polishing guide wire 20, ensuring sufficient travel for the drive assembly 12 to carry the rotary polishing conduit 30 along the rotary polishing guide wire 20. Therefore, the telescopic guide 13 effectively improves the ease of operation of the drive handle 10.

[0030] It should be noted that the telescopic guide 13 is positioned differently within the handle housing 11, and the components passing through the guide channel of the telescopic guide 13 are also different, thus the objects supported and guided by the telescopic guide 13 are also different.

[0031] The structure of the drive handle 10 will be further explained below, with regard to the structural arrangement of the telescopic guide 13 in the handle housing 11.

[0032] Combination Figure 1 and Figure 2 As shown, telescopic guides 13 are provided on both the proximal and distal sides of the drive assembly 12. For ease of explanation, the telescopic guide 13 located on the distal side of the drive assembly 12 is referred to as "first telescopic guide 13A", and the telescopic guide 13 located on the proximal side of the drive assembly 12 is referred to as "second telescopic guide 13B". Correspondingly, the guide channel formed by the first telescopic guide 13A is referred to as "first guide channel", and the guide channel formed by the second telescopic guide 13B is referred to as "second guide channel". Referring to Figure 3, the first telescopic guide 13A and the second telescopic guide 13B are respectively connected to the distal and proximal sides of the drive assembly 12. When the drive assembly 12 moves distally within the handle housing 11, the first telescopic guide 13A retracts and the second telescopic guide 13B extends; when the drive assembly 12 moves proximally within the handle housing 11, the first telescopic guide 13A extends and the second telescopic guide 13B retracts. In this embodiment, the distal end of the first telescopic guide 13A is connected to the handle housing 11, and the proximal end of the first telescopic guide 13A is connected to the drive assembly 12. The rotary grinding guide wire 20 and the drive shaft sleeved on the rotary grinding guide wire 20 are together inserted through the first guide channel of the first telescopic guide 13A, so that the first telescopic guide 13A can provide radial support and axial guidance for the drive shaft and the rotary grinding guide wire 20 located in the drive shaft.

[0033] The distal end of the second telescopic guide 13B is connected to the drive assembly 12, and the proximal end of the second telescopic guide 13B is connected to the handle housing 11. When the drive assembly 12 moves axially within the handle housing 11, it drives the second telescopic guide 13B to telescopically extend and retract. The proximal end of the drive shaft is connected to the drive assembly 13, and the proximal end of the spin-grinding guide wire 20 extends out from the proximal end of the drive shaft and passes through the second guide channel of the second telescopic guide 13B. Thus, the second telescopic guide 13B can provide radial support and axial guidance for the portion of the spin-grinding guide wire 20 extending from the proximal end of the drive shaft, making it less likely for the spin-grinding guide wire 20 to bend away from the circumferential direction, thus ensuring the stability of the spin-grinding guide wire 20.

[0034] It should be noted that the first telescopic guide 13A and the second telescopic guide 13B do not necessarily need to appear simultaneously. Specifically, removing one does not require the other to perform its function. For example, in some embodiments, the drive handle 10 is provided with a first telescopic guide 13A. Specifically, the distal end of the first telescopic guide 13A is connected to the handle housing 11, and the proximal end is connected to the drive assembly 12. This allows the first telescopic guide 13A to be linked with the drive assembly 12, so that when the drive assembly 12 moves axially relative to the handle housing 11, the drive assembly 12 can drive the first telescopic guide 13A to telescopically extend and retract. Since the drive shaft passes through the first guide channel, the first telescopic guide 13A can provide radial support and axial guidance for the drive shaft and the rotary grinding guide wire 20 located within the drive shaft during its telescopic movement. This ensures that the rotary grinding guide wire 20 and the drive shaft maintain good coaxiality and are not easily bent in the circumferential direction, thus ensuring the stability of the rotary grinding operation. It should be noted that the proximal end of the first telescopic guide 13A can be connected to the drive assembly 12 to achieve a linkage connection between the two. In some embodiments, the first telescopic guide 13A can also be inserted through the drive assembly 12 to achieve a linkage connection with the drive assembly 12. Specifically, the first telescopic guide 13A is inserted through the drive assembly 12, so that the proximal end of the first telescopic guide 13A extends from the proximal side of the drive assembly 12. Thus, the portion of the first telescopic guide 13A extending from the proximal side of the drive assembly 12 can be used to support and guide the portion of the rotary abrasion guide wire 20 near the proximal side of the drive assembly 12. In this way, the first telescopic guide 13A can not only support the drive shaft and the rotary abrasion guide wire 20 located within the drive shaft on the distal side of the drive assembly 12, but also support a portion of the structure of the rotary abrasion guide wire 20 located on the proximal side of the drive assembly 12, further stabilizing the overall rotary abrasion guide wire 20 so that the rotary abrasion guide wire 20 can stably guide the rotary abrasion guide tube 30 for rotary abrasion, thereby improving the rotary abrasion stability.

[0035] When the handle housing 11 of the drive handle 10 has two or more telescopic guide members 13, the structures of these telescopic guide members 13 can be the same or different. For example Figure 3 As shown, in some embodiments, when the first telescopic guide 13A and the second telescopic guide 13B have the same structure, the dimensions of the first telescopic guide 13A and the second telescopic guide 13B are different.

[0036] The structure of the telescopic guide 13 will be described below. The structure of the first telescopic guide 13A can be any of the telescopic guides 13 below, and the structure of the second telescopic guide 13B can also be any of the telescopic guides 13 below.

[0037] Specifically, in combination Figure 3 As shown, the telescopic guide 13 includes two or more sleeves 131, which are sleeved together and can move relative to each other along the axial direction.

[0038] To further understand the structure of the telescopic guide 13, the following will take the example of the telescopic guide 13 including a first sleeve 131a and a second sleeve 131b sleeved on the first sleeve 131a to further explain the structure of the telescopic guide 13.

[0039] Combination Figure 4 As shown, a rolling element 132 is provided between the first sleeve 131a and the second sleeve 131b that are nested together. More specifically, the rolling element 132 is mounted between the outer wall of the first sleeve 131a and the inner wall of the second sleeve 131b. When the first sleeve 131a and the second sleeve 131b move axially relative to each other, the rolling element 132 rolls between the outer wall of the first sleeve 131a and the inner wall of the second sleeve 131b, thereby improving the smoothness of the relative extension and retraction movement of the first sleeve 131a and the second sleeve 131b.

[0040] It should be noted that in embodiments where the telescopic guide 13 includes two or more sleeves 131, a rolling element 132 is provided between any two adjacent sleeves 131. When the telescopic guide 13 moves telescopically, the rolling element 132 makes rolling contact with the corresponding sleeve 131, thereby reducing the sliding friction between the sleeves 131 and improving the smoothness of the telescopic movement between the sleeves 131, so that the telescopic guide 13 can move telescopically and flexibly as a whole.

[0041] To improve the motion stability of the rolling element 132 during the telescopic guide 13's telescopic movement and prevent the rolling element 132 from moving arbitrarily and affecting the lubrication effect, a limiting structure is provided between adjacent sleeves 131 to limit the movement area of ​​the rolling element 132. Combined with... Figure 4 As shown, taking the structure between the first sleeve 131a and the second sleeve 131b as an example, a first limiting part 1311 and a second limiting part 1312 are formed on the inner wall side of the second sleeve 131b. The rolling element 132 is limited to the area Q defined between the first limiting part 1311 and the second limiting part 1312, so that the rolling element 132 will not slide out from between the first sleeve 131a and the second sleeve 131b.

[0042] Combination Figure 4 and Figure 5 As shown, a third limiting part 1313 is formed at one end of the first sleeve 131a. The third limiting part 1313 is used to abut against the first limiting part 1311 to limit the maximum extension length of the first sleeve 131a relative to the second sleeve 131b.

[0043] The first limiting part 1311 may be an annular protrusion surrounding the second sleeve 131b along its axial direction. For example, the wall of the second sleeve 131b may be pressed inward, causing a portion of the wall of the second sleeve 131b to be concave to form an annular protrusion. This structure is easy to process.

[0044] The structure of the second limiting portion 1312 can be the same as that of the first limiting portion 1311. In some embodiments, the structure of the second limiting portion 1312 can also be different from that of the first limiting portion 1311. For example, the second limiting portion 1312 is formed at the end of the second sleeve 131b for the first sleeve 131a to extend out. Specifically, the second limiting portion 1312 is formed by bending the wall of the second sleeve 131b inward at the corresponding end. As another example, the second limiting portion 1312 and the second sleeve 131b are separate structures. Specifically, an annular baffle can be connected to the end of the second sleeve 131b, thereby forming the second limiting portion 1312. Understandably, the inner diameter of the annular baffle is adapted to the outer diameter of the first sleeve 131a, so that the first sleeve 131a can movably extend into the second sleeve 131b through the inner circle of the annular baffle. The annular baffle can be connected to the second sleeve 131b by welding, glue connection or threaded connection, etc., and there is no limitation here.

[0045] The third limiting part 1313 can be formed by the outward expansion of a portion of the wall structure of the first sleeve 131a. For example, in combination with Figure 4 and Figure 5 As shown, the third limiting portion 1313, formed by the outward expansion of the tube wall at the end of the first sleeve 131a, is flared in shape. When the first sleeve 131a moves axially within the second sleeve 131b until the third limiting portion 1313 contacts the first limiting portion 1311, the first sleeve 131a reaches its maximum extension length from within the second sleeve 131b, and thus cannot continue to extend from the second sleeve 131b. In other embodiments, the third limiting portion 1313 may be a protrusion formed on the outer wall of the first sleeve 131a, which is not limited here.

[0046] It should be noted that, since the rolling element 132 is constrained between the first limiting part 1311 and the second limiting part 1312, and when the third limiting part 1313 abuts against the first limiting part 1311, it can also restrict the first sleeve 131a from continuing to extend from the second sleeve 131b. This ensures that there are always nested tube segments between the first sleeve 131a and the second sleeve 131b, which helps to ensure the coaxiality of the first sleeve 131a and the second sleeve 131b and improves the stability of the relative telescopic movement of the first sleeve 131a and the second sleeve 131b.

[0047] In some embodiments, when the first sleeve 131a and the second sleeve 131b are in their maximum extended positions, the third limiting part 1313 abuts against the first limiting part 1311 to restrict the first sleeve 131a from continuing to extend from the second sleeve 131b. The length of the interlocking tube segments between the first sleeve 131a and the second sleeve 131b is 2cm to 5cm, for example, 2cm, 3cm, 4cm, or 5cm. By controlling the length of the interlocking tube segments between the first sleeve 131a and the second sleeve 131b to within the range of 2cm to 5cm, it is possible to ensure good coaxiality between the first sleeve 131a and the second sleeve 131b, while avoiding excessively long interlocking tube segments, so that the first sleeve 131a and the second sleeve 131b can obtain the longest possible extension stroke.

[0048] Based on the fact that the first sleeve 131a is inserted into the second sleeve 131b at the corresponding second limiting part 1312, without considering the design and assembly errors between the structures, the length of the nested pipe segments can be understood as the distance between the first limiting part 1311 and the second limiting part 1312.

[0049] It should be noted that the first sleeve 131a and the second sleeve 131b are cylindrical tubes, but the inner wall is not limited to being cylindrical. For example, in some embodiments, the first sleeve 131a and the second sleeve 131b are respectively formed with a first abutting surface and a second abutting surface. The first abutting surface and the second abutting surface are both planes parallel to the axial direction of the telescopic guide 13. The first abutting surface and the second abutting surface are parallel to each other, and the rolling element 132 rolls against the first abutting surface and the second abutting surface.

[0050] The rolling element 132 is preferably a spherical ball or a cylindrical ball.

[0051] like Figure 4 As shown, the outer wall of the first sleeve 131a and / or the inner wall of the second sleeve 131b are provided with a lubricating coating 133. The rolling element 132 is in contact with the lubricating coating 133 to improve the smoothness of the first sleeve 131a and the second sleeve 131b under the rolling support of the rolling element 132. The material of the lubricating coating 133 is preferably polytetrafluoroethylene grease.

[0052] Combination Figure 5 As shown, the first sleeve 131a has a liquid passage hole 134 on its wall, which is used to allow liquid to flow to the rolling element 132. It should be noted that the liquid entering through the liquid passage hole 134 to the location of the rolling element 132 can be either coolant or lubricant.

[0053] For example, in some embodiments, the fluid inlet 134 can allow coolant to flow into the location of the rolling element 132 to cool the rolling element 132. Furthermore, the handle housing 11 has a fluid reservoir near its proximal end to store coolant.

[0054] For example, in some embodiments, lubricating fluid can be introduced into the location of the rolling element 132 through the fluid inlet 134 to reduce friction during movement by utilizing the lubricating effect of the lubricating fluid. This allows the rolling element 132 to slide or roll smoothly with the telescopic guide 13, reducing jamming and improving the operator's handling and the flexibility of axial movement of the drive assembly 12.

[0055] In some embodiments, the handle housing 11 is provided with a support portion for supporting the telescopic guide 13. It should be noted that there may be one or more support portions; for example, the handle housing 11 may have two or more support portions.

[0056] To facilitate understanding, the following example, which uses a first telescopic guide 13A and a second telescopic guide 13B provided inside the handle housing 11, will be used to further explain the structural configuration of the support portion of the handle housing 11.

[0057] Combination Figure 2 As shown, a first support portion 111 and a second support portion 112 are provided inside the handle housing 11. The first support portion 111 and the second support portion 112 are spaced apart along the axial direction of the handle housing 11 and are used to support the first telescopic guide member 13A. The first telescopic guide member 13A is kept along the wire guide cavity 10a of the handle housing 11 by the action of the first support portion 111 and the second support portion 112.

[0058] The handle housing 11 is provided with a third support portion 113 and a fourth support portion 114, which are spaced apart along the axial direction of the handle housing 11 and are used to support the second telescopic guide member 13B. The second telescopic guide member 13B is kept along the wire guide cavity 10a of the handle housing 11 by the action of the third support portion 113 and the fourth support portion 114.

[0059] The support portion can be part of the structure of the handle housing 11. For example, the support portion is a rib protruding from the inner wall of the handle housing 11, with holes for the corresponding telescopic guide 13 to pass through. Understandably, these holes are located on the axis of the guide wire cavity 10a, so that the telescopic guide 13 passing through the holes is positioned along the guide wire cavity 10a. In some embodiments, after the telescopic guide 13 passes through the holes, it is connected and fixed to the rib with glue. In this way, the rib not only supports the telescopic guide 13, but also limits the position of the telescopic guide 13 connected to the rib, improving the connection stability between the telescopic guide 13 and the rib. This facilitates the stable support and guidance of the structure passing through it when the telescopic guide 13 moves telescopically within the handle housing 11.

[0060] Combination Figure 6 As shown, the handle housing 11 includes a first housing 11a and a second housing 11b. The first housing 11a and the second housing 11b can be connected by snap-fit ​​or by screws or other connecting parts. By combining the first housing 11a and the second housing 11b, it is easy to assemble components such as the drive assembly 12 and the telescopic guide 13 inside the handle 10 into the handle housing 11.

[0061] In an embodiment where the support portion is a rib protruding from the inner wall of the handle housing 11, ribs are provided at corresponding positions on the inner walls of the first housing 11a and the second housing 11b. The ribs have grooves, and after the first housing 11a and the second housing 11b are engaged, the grooves on the opposing ribs align to form a hole for the telescopic guide 13 to pass through. Using this structure, when installing the telescopic guide 13, it can be first installed into the groove of the first housing 11a or the second housing 11b along the guide wire cavity 10a, and then the first housing 11a and the second housing 11b can be fastened together to complete the installation of the telescopic guide 13.

[0062] In some implementations, combined Figure 2 As shown, the drive handle 10 includes a locking wire assembly 14, which is disposed within the handle housing 11 and located proximal to the drive assembly 12. In this embodiment, the locking wire assembly 14 is used to lock the rotatory guide wire 20 passing through the guide wire cavity 10a, so that during rotatory grinding, the rotatory guide wire 20 will not move axially or rotate around the axial direction with the rotatory guide tube 30, thereby stably guiding the rotatory guide tube 30 for rotatory grinding and improving rotatory grinding stability. The structure of the locking wire assembly 14 is not limited here. The locking wire assembly 14 can be a clamp or a top wire passing through the handle housing 11, as long as the locking wire assembly 14 can fix the rotatory guide wire 20 relative to the handle housing 11 when needed.

[0063] In embodiments where the drive handle 10 includes a locking wire assembly 14, the locking wire assembly 14 can be used to pull the proximal end of the second telescopic guide 13B. Specifically, the proximal end of the second telescopic guide 13B is connected to the locking wire assembly 14, and the distal end of the second telescopic guide 13B is connected to the drive assembly 12. Thus, when the drive assembly 12 moves axially within the handle housing 11, the drive assembly 12 moves closer to or further away from the locking wire assembly 14, causing the second telescopic guide 13B located between the drive assembly 12 and the locking wire assembly 14 to be stretched or compressed. This allows the second telescopic guide 13B to telescopically move with the axial movement of the drive assembly 12, satisfying the axial movement stroke requirements of the drive assembly 12 and the rotary grinding guide 30 while minimizing the length of the drive handle 10, so that the drive handle 10 can be easily operated for rotary grinding operations.

[0064] See again Figure 1 As shown, the rotational atherectomy catheter 30 includes a rotational atherectomy head 31, a drive flexible shaft 32, and a sheath (not shown). The rotational atherectomy head 31 is olive-shaped, and the distal portion of the rotational atherectomy head 31 can be provided with particles to enhance friction, such as diamond particles with a size of 20 to 30 micrometers. In this way, when the rotational atherectomy head 31 abrades atherosclerotic plaques in diseased blood vessels, the particles in its distal portion also have a better abrasion effect.

[0065] The swirl head 31 can be driven by the flexible drive shaft 32. Specifically, the swirl head 31 is connected to the distal end of the flexible drive shaft 32, and the proximal end of the flexible drive shaft 32 is connected to the distal end of the drive shaft, so that when the drive assembly 12 drives the drive shaft to rotate, the drive shaft drives the swirl head 31 to rotate via the flexible drive shaft 32. In some embodiments, the distal end of the drive shaft is provided with a first engagement portion (not shown in the figure), and the proximal end of the flexible drive shaft 32 is provided with a second engagement portion (not shown in the figure) for cooperating with the first engagement portion. The engagement of the first engagement portion and the second engagement portion is used to connect the flexible drive shaft 32 and the drive shaft, and then the drive shaft can drive the flexible drive shaft 32 to move. Further, a limiting sleeve can be sleeved on the drive shaft or the flexible drive shaft 32. After the first engagement portion and the second engagement portion are engaged, the limiting sleeve is pushed axially to a position covering the first engagement portion and the second engagement portion, restricting the separation of the first engagement portion and the second engagement portion, thereby improving the connection stability between the drive shaft and the flexible drive shaft 32.

[0066] Continue reading Figure 1As shown, in some embodiments, a track 15 is provided inside the handle housing 11 to support the drive assembly 12, thereby improving the stability of the drive assembly 12 moving axially within the handle housing 11. After adjusting the axial position of the drive assembly 12 within the handle housing 11, the rotational ablation catheter 30, which is connected to the drive assembly 12 via a drive shaft, can move within the blood vessel to abrade atherosclerotic plaques in the diseased blood vessel, ultimately opening the blood vessel.

[0067] The flexible drive shaft 32 is a flexible tubular component, and its cavity allows the rotary abrasion guidewire 20 to pass through, thus facilitating the use of the flexible drive shaft 32 to push the rotary abrasion head 31 along the rotary abrasion guidewire 20 to the desired abrasion position. During the rotary abrasion process, as the drive assembly 12 moves axially within the handle housing 11, the flexible drive shaft 32 can move axially along the drive shaft, carrying the rotary abrasion head 31 along the rotary abrasion guidewire 20 within the diseased blood vessel (e.g., the distance of each forward and backward movement is controlled within 4 cm) to progressively abrade the atherosclerotic plaque. Understandably, during the rotary abrasion process, when the rotary abrasion head 31 encounters slight resistance from the atherosclerotic plaque, the flexible drive shaft 32 can push the rotary abrasion head 31 distally to ensure good contact between the rotary abrasion head 31 and the atherosclerotic plaque, thus ensuring the abrasion effect. Of course, this doesn't mean the atherectomy head 31 needs to remain in constant contact with the atherosclerotic plaque. To avoid prolonged contact of the atherectomy head 31 with the same area in the diseased blood vessel, which could damage the local tissue, it's best to retract the atherectomy head 31 proximally after a certain amount of rotation. For example, retract the atherectomy head 31 proximally after each 25-second rotation to remove it from the atherosclerotic plaque. This prevents the atherectomy head 31 from overheating during prolonged rotation, which can hinder the release of debris and increase the risk of thrombosis.

[0068] The sheath can be made of polytetrafluoroethylene (PTFE). The sheath is fitted over the outer side of the flexible drive shaft 32 to prevent damage to the blood vessel wall during rotational ablation, thus protecting the vessel wall. Furthermore, during rotational ablation, a cleaning solution can be injected into the ablation site through the sheath to reduce frictional and thermal damage, and to flush away any particles that fall off during the process, preventing embolism. The cleaning solution can be physiological saline.

[0069] In some embodiments, the rotational ablation guidewire 20 may be made of stainless steel. The diameter and length of the rotational ablation guidewire 20 are not limited, as long as they are suitable for the needs of rotational ablation surgery. For example, the length of the rotational ablation guidewire 20 may be 300 cm. The material and specifications of the rotational ablation guidewire 20 are not limited herein.

[0070] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above 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.

[0071] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A drive handle, characterized in that, include: The handle housing has a guide wire cavity that extends through the proximal and distal ends of the handle housing and is used for passing a rotary abrasion guide wire. A drive assembly is disposed within the handle housing and is movable along the rotary polishing guide wire. The drive assembly is used to drive a drive shaft to rotate around the rotary polishing guide wire, and the drive shaft is sleeved on the rotary polishing guide wire. A first telescopic guide is disposed along the guide wire cavity and forms a first guide channel. The drive shaft and the rotary polishing guide wire are movably inserted through the first guide channel. The distal end of the first telescopic guide is connected to the handle housing. The first telescopic guide is linked to the drive assembly. When the drive assembly and the drive shaft move along the rotary polishing guide wire, the first telescopic guide moves telescopically within the handle housing. The first telescopic guide includes a first sleeve and a second sleeve sleeved on the first sleeve. A rolling element is mounted between the outer wall of the first sleeve and the inner wall of the second sleeve. When the first sleeve and the second sleeve move telescopically relative to each other in the axial direction, the rolling element rolls between the outer wall of the first sleeve and the inner wall of the second sleeve. The rolling element is a spherical ball or a cylindrical ball.

2. The drive handle according to claim 1, characterized in that, The first sleeve and the second sleeve are respectively formed with a first abutting surface and a second abutting surface. The first abutting surface and the second abutting surface are both planes parallel to the axial direction of the first telescopic guide. The first abutting surface and the second abutting surface are parallel to each other. The rolling element rolls against the first abutting surface and the second abutting surface.

3. The drive handle according to claim 1, characterized in that, The outer wall of the first sleeve and / or the inner wall of the second sleeve are provided with a lubricating coating, and the rolling element is in contact with the lubricating coating.

4. The drive handle according to claim 3, characterized in that, The first sleeve has a liquid passage hole in its wall, which is used to allow liquid to flow to the rolling element.

5. The drive handle according to claim 1, characterized in that, A first limiting part and a second limiting part are formed on one side of the inner wall of the second sleeve, and the rolling element is limited between the first limiting part and the second limiting part.

6. The drive handle according to claim 5, characterized in that, A third limiting part is formed at one end of the first sleeve, which is used to abut against the first limiting part to limit the maximum extension and retraction length of the first sleeve relative to the second sleeve.

7. The drive handle according to claim 1, characterized in that, The proximal end of the first telescopic guide is connected to the drive assembly, or the first telescopic guide passes through the drive assembly such that the proximal end of the first telescopic guide extends from the proximal side of the drive assembly.

8. The drive handle according to claim 1, characterized in that, The device includes a second telescopic guide, the proximal end of which is connected to the handle housing and forms a second guide channel along the guide wire cavity. The spin-ground guide wire is movably inserted through the second guide channel. The first telescopic guide and the second telescopic guide are respectively connected to the proximal side and the distal side of the drive assembly. When the drive assembly moves distally within the handle housing, the first telescopic guide retracts and the second telescopic guide extends. When the drive assembly moves proximally within the handle housing, the first telescopic guide extends and the second telescopic guide retracts.

9. The drive handle according to claim 8, characterized in that, The structure of the second telescopic guide is the same as that of the first telescopic guide.

10. A rotary milling system, characterized in that, The invention includes a drive handle as described in any one of claims 1-9, a rotary ablation guidewire and a rotary ablation conduit, wherein the rotary ablation guidewire passes through the guidewire cavity and the proximal end of the rotary ablation guidewire extends out of the proximal end of the guidewire cavity, the rotary ablation conduit is sleeved on the rotary ablation guidewire, and the proximal end of the rotary ablation conduit is connected to the distal end of the drive shaft.

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