WO2021227856A1

WO2021227856A1 - Cutting device and cutting system

Info

Publication number: WO2021227856A1
Application number: PCT/CN2021/089929
Authority: WO
Inventors: 洛坦哈伊姆; 王永胜; 高国庆
Original assignee: 杭州德诺睿华医疗科技有限公司
Priority date: 2020-05-09
Filing date: 2021-04-26
Publication date: 2021-11-18

Abstract

A cutting device (20), comprising a cutting member (40) and a valve leaflet positioning mechanism (30). The cutting member (40) is provided with a cutting section (42) at a distal end, and the cutting section (42) is electrically connected to an ablation power supply at a proximal end; the cutting section (42) is used to cut a valve leaflet; and the valve leaflet positioning mechanism (30) is used to stabilize the position of the cut valve leaflet. Since the valve leaflet positioning mechanism (30) is capable of stabilizing the position of the cut valve leaflet, the cutting part (42) is placed on a valve leaflet to be cut and forms a radial cut on the cut valve leaflet by moving. The cut valve leaflet splits and forms an opening at a coronary artery, and may push open an original valve leaflet when a transcatheter heart valve is implanted. Therefore, the cut valve leaflet will not block the coronary artery orifice and will prevent the original valve leaflet from covering the coronary artery orifice during transcatheter aortic valve replacement and cause blocking. Also disclosed is a cutting system (100) provided with the cutting device (20).

Description

Cutting device and cutting system

Technical field

This application relates to the technical field of interventional medical devices, and in particular to a cutting device and a cutting system that can be used for degenerative valves.

Background technique

After 10 to 20 years of surgical replacement of the biological valve by the aortic valve, the biological valve will gradually undergo degeneration, that is, stenosis, insufficiency, or both. Valve disease caused by degenerative disease, the connective tissue of the body undergoes degenerative changes, resulting in changes in the structure of the valve leaflets, chordae and annulus, leading to calcification, relaxation, and prolapse of the valve leaflets. The valve disease is called degenerative Valvular disease.

With the rapid development of transcatheter aortic valve replacement, high-risk patients with aortic valve stenosis, especially the elderly and frail patients, have a relatively safe and effective alternative to minimally invasive treatment. However, a small number of patients may experience coronary artery obstruction during catheter aortic valve replacement; the coronary artery obstruction is a rare but fatal complication, especially for some patients with abnormal heart structures, such as valves The valve leaflets are abnormally large or the aortic root is abnormally small; in transcatheter aortic valve replacement, when the prosthetic valve stent is opened, the valve leaflets may obstruct blood flow to the coronary arteries. The leaflet cutting technique can be used to prevent coronary artery occlusion during transcatheter aortic valve replacement. Specifically, the valve leaflet cutting technology is mainly aimed at patients whose original surgical valve implanted has failed. When the patient cannot tolerate resurgical valve replacement and needs to undergo transcatheter aortic valve replacement; if the original surgical biological valve leaflet blocks the coronary artery Oral risk is extremely high. The leaflet cutting technology can be used to cut the leaflets of the original surgical bioprosthesis. Through the valve leaflet cutting, the leaflets of the original surgical bioprosthesis can be prevented from covering the coronary artery during transcatheter aortic valve replacement. The mouth causes occlusion; however, there are currently no instruments specifically designed for leaflet cutting techniques.

Summary of the invention

In view of this, the purpose of the present application is to provide a cutting device and a cutting system capable of cutting valve leaflets.

In order to solve the above technical problems, the present application provides a cutting device, which includes a valve leaflet positioning mechanism and a cutting member. The distal end of the cutting member is provided with a cutting portion, and the proximal end of the cutting member is electrically connected to an ablation power source. The cutting part is used for cutting the valve leaflet, and the valve leaflet positioning mechanism is used for stabilizing the position of the cutting valve leaflet.

The present application also provides a cutting system, which includes a cutting device and an operating handle, the operating handle is provided at the proximal end of the cutting device, and the operating handle is used to control the valve leaf positioning mechanism and the cutting member of the cutting device .

The cutting device of the present application includes a valve leaflet positioning mechanism and a cutting member. The distal end of the cutting member is provided with a cutting portion, and the proximal end of the cutting member is electrically connected to an ablation power source. The cutting portion is used to cut the valve leaflets. , The leaflet positioning mechanism is used to stabilize the position of the cutting leaflet. Since the leaflet positioning mechanism can stabilize the position of the cutting leaflet to prevent the cutting leaflet from swinging up and down, the cutting part is placed on the leaflet to be cut and moved to move the cutting leaflet on the cutting leaflet. A radial cut is formed on the upper part, and the cut leaflet splits and forms an opening at the coronary artery. That is, the original leaflet is divided into two. When it is implanted by a transcatheter heart valve, the original leaflet can be pushed apart. Therefore, the cut leaflets will no longer block the coronary ostium, thereby avoiding the original leaflet covering the coronary ostium during transcatheter aortic valve replacement and causing occlusion.

Description of the drawings

In order to explain the technical solutions of the embodiments of the present application more clearly, the following will briefly introduce the drawings that need to be used in the embodiments. Obviously, the drawings in the following description are some embodiments of the present application, which are common in the field. As far as technical personnel are concerned, they can also obtain other drawings based on these drawings without creative work.

Fig. 1 is a schematic structural diagram of a cutting system provided by a first embodiment of the present application;

Fig. 2 is a schematic diagram of the three-dimensional structure of the cutting device in Fig. 1;

Fig. 3 is a perspective exploded schematic view of the cutting device in Fig. 2;

Fig. 4 is a perspective view of the cutting device in Fig. 3 from another perspective;

Figure 5 is a three-dimensional assembly view of the cutting device in Figure 4;

Fig. 6 is a cross-sectional view of the cutting device in Fig. 2 along the line VI-VI;

Fig. 7 is a schematic diagram of the state of use of the cutting device in Fig. 2;

FIG. 8 is a schematic diagram from another perspective of the use state of the cutting device in FIG. 7; FIG.

Figure 9 is a cross-sectional view of the cutting device in Figure 7 along line IX-IX;

10 is a schematic diagram of a three-dimensional structure of a cutting device provided by a second embodiment of the present application;

FIG. 11 is a schematic diagram of a three-dimensional structure of a cutting device provided by a third embodiment of the present application.

Detailed ways

The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in this application, all other embodiments obtained by a person of ordinary skill in the art without creative work shall fall within the protection scope of this application.

In the description of this application, the “proximal end” in this application refers to the end close to the control of the operator, and the “distal end” refers to the end far away from the control of the operator. The axial direction refers to the direction of the central axis of the device, and the radial direction is the direction perpendicular to the central axis. This definition is only for the convenience of expression and cannot be understood as a limitation of the present application.

Please refer to FIGS. 1 and 2 together. FIG. 1 is a schematic structural diagram of a cutting system 100 provided by a first embodiment of the present application; FIG. 2 is a three-dimensional structural schematic diagram of the cutting device 20 in FIG. 1. The present application provides a cutting system 100, which includes a cutting device 20 and an operating handle 70 provided at the proximal end of the cutting device 20. The cutting device 20 includes a leaflet positioning mechanism 30 and a cutting member 40. The distal end of the cutting member 40 is provided with a cutting device. The proximal end of the cutting portion 42 is electrically connected to an ablation power source (not shown in the figure). The cutting portion 42 is used to cut the valve leaflets; the leaflet positioning mechanism 30 is used to stabilize the position of the cutting leaflet, and the operating handle 70 is used to control The valve leaflet positioning mechanism 30 and the cutting member 40 work; specifically, the operating handle 70 controls the valve leaflet positioning mechanism 30 for stabilizing the position of the cutting leaflet, and the operating handle 70 controls the cutting portion 42 for cutting the valve leaflet positioning mechanism 30 after positioning. The leaflets to be cut.

The cutting part 42 in the present application is a tip that is electrically connected to the ablation power source. When the tip is placed in a suitable position of the cutting leaflet, the proximal end of the cutting member 40 is connected to the ablation power source, and then the cutting part 42 is moved. That is, the valve leaflet to be cut can be cut. Specifically, by controlling the operating handle 70 to control the adjustable bending angle of the distal end of the cutting member 40, the cutting portion 42 can more accurately determine the position and angle of the leaflet cutting. Since the leaflet positioning mechanism 30 can stabilize the position of the leaflet to be cut to prevent the leaflet to be cut from swinging up and down, the cutting portion 42 is placed on the leaflet to be cut and is adjusted by adjusting the distal end of the cutting member 40 The control of the bending angle can more accurately realize the moving position and angle of the cutting part 42 to cut the leaflet to be cut, the cut leaflet splits, and an opening is formed at the coronary artery, that is, the original leaflet is divided Second, the cut valve leaflet will no longer block the coronary ostium, thereby avoiding the original valve leaflet covering the coronary ostium during transcatheter aortic valve replacement and causing occlusion.

In another embodiment, the cutting device 20 described in the present application can be used for cutting the leaflets of the mitral valve or tricuspid valve, for example, can be used for transcatheter mitral valve anterior leaflet tearing, effectively preventing the left ventricular outflow tract Of obstruction.

Please refer to FIGS. 3 and 4 together. FIG. 3 is an exploded perspective view of the leaflet cutting device 20 in FIG. 2; FIG. 4 is a perspective view of the leaflet cutting device 20 in FIG. 3 from another perspective. The valve leaflet positioning mechanism 30 includes a distal positioning member 31 and a proximal positioning member 35. The distal positioning member 31 is used to press against the distal surface of the valve leaflet to be cut, and the proximal positioning member 35 is used to press against the The proximal face of the leaflet to be cut. Specifically, the distal positioning member 31 includes a positioning frame 311 provided at the distal end, an adjusting rod 315 inserted in the middle of the positioning frame 311 along the axial direction, and an adjusting tube 317 movably sleeved on the adjusting rod 315, the positioning frame 311 is used for positioning from the distal surface of the leaflet to be cut to prevent the leaflet to be cut from shifting to the distal end and facilitate stable cutting of the cutting portion 42. The proximal end of the distal positioning member 31 is provided with at least one point, line or surface that abuts the leaflet to be cut. In this embodiment, the proximal surface of the positioning frame 311 abuts the leaflet to be cut. The positioning frame 311 is a woven frame or a grid frame that can be elastically expanded and contracted. The positioning frame 311 is expanded to radially support the inner wall of the valve leaflet to be cut. For example, the aortic valve of the valve leaflet to be cut is expanded. It can be radially supported on the inner wall of the aorta. Specifically, the positioning frame 311 can be made by cutting an elastic tube, and the material of the elastic tube is a memory metal material, preferably a nickel-titanium alloy material; the positioning frame 311 can also be braided with nickel alloy wires, or partially braided and combined with partial pipes. It is processed by cutting, and different parts can be welded or fixed to each other by connecting pieces. The overall shape of the positioning frame 311 can be a disk shape, a cone shape, and other suitable shapes, which are not limited here. In this embodiment, after the positioning frame 311 is completely released, the cross-section passing through the axis of the positioning frame 311 is prismatic.

In this embodiment, when the distal positioning member 31 is completely released, the positioning frame 311 is generally a conical frame. When the valve leaflet cutting device 20 is implanted in the aorta, the positioning frame 311 supports the aorta The inner wall of the valve so that the distal surface of the leaflet to be cut contacts the proximal surface of the positioning frame 311 to prevent the leaflet to be cut from moving distally. The radial dimension of the positioning frame 311 after being completely released is equal to or slightly larger than the inner diameter of the aorta. In this embodiment, the positioning frame 311 is provided with a support surface 3110 at the proximal end. The support surface 3110 is used to support the distal surface of the leaflet to be cut to prevent the leaflet to be cut from moving to the distal end.

The positioning frame 311 is located between the distal end of the adjusting rod 315 and the distal end of the adjusting tube 317. The relative distance between the distal end of the adjusting rod 315 and the distal end of the adjusting tube 317 is changed to adjust the radial size of the positioning frame 311, and adjust The axial distance between the distal end of the rod 315 and the distal end of the adjusting tube 317 can also be changed. For example, the adjusting rod 315 moves in the axial direction relative to the adjusting tube 317 to change the radial size and the axial size of the positioning bracket 311. Specifically, the proximal ends of the adjusting rod 315 and the adjusting tube 317 are both connected to the operating handle 70, and the axial distance between the distal end of the adjusting rod 315 and the distal end of the adjusting tube 317 can be controlled by the operating handle 70, for example, by operating the handle 70 can control the adjusting rod 315 to slide relative to the adjusting tube 317 in the axial direction. When the distal end of the adjusting rod 315 is relatively close to the distal end of the adjusting tube 317, the axial size of the positioning frame 311 is reduced, and the radial direction of the positioning frame 311 is reduced. The size is increased to effectively support the inner wall of the aorta; when the distal end of the adjusting rod 315 is relatively far away from the distal end of the adjusting tube 317, the axial size of the positioning frame 311 increases, and the radial direction of the positioning frame 311 The size is reduced to facilitate the shrinkage of the positioning frame 311.

The distal end of the positioning frame 311 converges and is connected to the adjustment rod 315, and the proximal end of the positioning frame 311 converges around the adjustment rod 315 and can slide axially with respect to the adjustment rod 315; the distal end of the adjustment tube 317 is axially toward the distal end Press against the proximal end of the positioning frame 311 to increase the radial size of the positioning frame 311. Specifically, the converging part of the distal end of the positioning frame 311 and the distal end of the adjusting rod 315 can be fixedly connected or movably connected; when the distal end of the positioning frame 311 is fixedly connected to the distal end of the adjusting rod 315, the adjusting rod 315 is along the axis. Sliding relative to the adjusting tube 317 can drive the distal end of the positioning frame 311 to move proximally or distally; when the distal end of the positioning frame 311 is movably connected with the distal end of the adjusting rod 315, that is, the distal end of the positioning frame 311 is along the axial direction. The adjusting rod 315 is slidably sleeved on the adjusting rod 315, and the distal end of the adjusting rod 315 is provided with an abutting piece, and the abutting piece slides toward the proximal end along the axial direction of the adjusting rod 315 to abut against the converging point of the distal end of the positioning frame 311. The proximal end of the positioning frame 311 and the distal end of the adjusting tube 317 can be fixedly connected or movably connected; when the proximal end of the positioning frame 311 is connected to the distal end of the adjusting tube 317, the adjusting tube 317 is axially opposite to The sliding of the adjusting rod 315 can drive the proximal end of the positioning frame 311 to move to the proximal end or the distal end; when the proximal end of the positioning frame 311 is movably connected with the distal end of the adjusting tube 317, that is, the proximal end of the positioning frame 311 slides along the axial direction. It is arranged on the adjusting rod 315, and the distal end of the adjusting tube 317 is provided with abutting pieces. The radial dimension of the positioning frame 311.

In this embodiment, the distal end of the positioning frame 311 converges and is fixedly connected to the distal end of the adjustment rod 315, and the proximal end of the positioning frame 311 converges and is fixedly connected to the distal end of the adjustment tube 317; the adjustment tube 317 is axially opposite to the adjustment rod 315. Moving the rod 315 to the distal end can increase the radial dimension of the positioning frame 311 and reduce the axial dimension of the positioning frame 311; moving the adjusting tube 317 proximally relative to the adjusting rod 315 in the axial direction can reduce the radial dimension of the positioning frame 311 And increase the axial size of the positioning frame 311.

As shown in FIGS. 3 and 4, the positioning frame 311 includes a plurality of prismatic first positioning rods 3112, a plurality of prismatic second positioning rods 3114, and a distal end connected to each first positioning rod 3112 and a corresponding first positioning rod 3112. The connecting portion 3115 between the proximal ends of the two positioning rods 3114. Specifically, the proximal end of each first positioning rod 3112 is connected to the distal end of the adjusting tube 317, and when the positioning frame 311 is fully expanded, each first positioning rod 3112 is inclined outward from the adjusting tube 317 and to the distal end. Extension, that is, the angle between each first positioning rod 3112 and the axis of the adjusting tube 317 is greater than 0 degrees and less than 90 degrees, preferably between 45 degrees and 60 degrees; a number of first positioning rods 3112 extend along the adjusting tube 317 is arranged in a circle in the circumferential direction. The distal end of each second positioning rod 3114 is connected to the distal end of the adjusting rod 315, and when the positioning frame 311 is fully deployed, each second positioning rod 3114 extends outward from the adjusting rod 315 and obliquely toward the proximal end, namely The angle between each second positioning rod 3114 and the axis of the adjusting rod 315 is greater than 0 degrees and less than 90 degrees, preferably between 45 degrees and 60 degrees; the number of second positioning rods 3114 is the same as that of the first positioning rods. The number of 3112 is the same, and several second positioning rods 3114 are arranged in a circle along the circumferential direction of the adjusting rod 315. Each connecting portion 3115 is an outwardly curved arc-shaped piece, and the distal end of each first positioning rod 3112 and the corresponding proximal end of the second positioning rod 3114 are respectively connected to the proximal end and the distal end of the corresponding connecting portion 3115, There is a smooth transition between the first positioning rod 3112 and the connecting portion 3115, and a smooth transition between the second positioning rod 3114 and the connecting portion 3115. Therefore, when the distal end of the positioning frame 311 is closer to the proximal end, the radial size of the positioning frame 311 increases and the axial size decreases; when the distal end of the positioning frame 311 is farther away from the proximal end, the diameter of the positioning frame 311 The axial size decreases while the axial size increases.

In other embodiments, a number of developing points are provided on the positioning frame 311, and the developing points are fixed by inlay and hot pressing. Specifically, one of the plurality of first positioning rods 3112, the plurality of second positioning rods 3114, and the plurality of connecting parts 3115 of the positioning frame 311 is provided with at least one circle of developing points; Two of the three of the positioning rods 3114 and the connecting parts 3115 are respectively provided with at least one circle of developing points; or the first positioning rods 3112, the second positioning rods 3114, and the connecting parts 3115 are respectively provided with at least one circle It is convenient to locate the positioning frame 311 in the lumen of the aorta. The developing point can be made of gold, platinum, tantalum and other materials.

In other embodiments, at least one ring of flexible developing wire is arranged on the positioning frame 311, and the developing wire is fixed by winding, inlay, and hot pressing.

In other embodiments, the first positioning rod 3112 and the second positioning rod 3114 of the positioning frame 311 may be waist-shaped positioning rods, X-shaped positioning rods or V-shaped positioning rods arranged in a circumferential direction in sequence.

In other embodiments, the positioning frame 311 can also be woven with nickel alloy wires into a ring-shaped grid structure, the proximal end of the grid structure is convergently connected to the distal end of the regulating tube 317, and the distal end of the grid structure The convergent connection is connected to the distal end of the adjusting rod 315.

As shown in FIGS. 3 and 4, the proximal positioning member 35 includes at least one compression frame 351. Specifically, the compression frame 351 is a single-loop frame, a woven frame, or a grid frame that can be expanded and contracted. In the valve leaflet cutting operation, the pressure frame 351 can press against the proximal surface of the leaflet to be cut, that is, the leaflet to be cut is clamped between the pressure frame 351 and the positioning frame 311, which can effectively treat the cut leaflet The control is performed to prevent the valve leaflet to be cut from moving proximally or distally, stabilize the valve leaflet to be cut, and realize more stable cutting of the valve leaflet to be cut.

The side of the pressure frame 351 facing the positioning frame 311 is provided with at least one point, line or surface for pressing against the leaflet to be cut; in this embodiment, the pressure frame 351 can be cut by using an elastic tube. The material of is a memory metal material, preferably a nickel-titanium alloy material; the compression frame 35 can also be braided with nickel alloy wire, or processed in a manner of partial braiding and partial pipe cutting, and different parts can be welded or fixed to each other by connecting pieces. The overall shape of the pressing frame 35 may be sheet-like, which is not limited here. In this embodiment, the pressing frame 351 is completely released into a petal structure, which can be formed by cutting or weaving; the pressing frame 351 is a single petal structure, so The single petal structure is surrounded by a metal wire or polymer wire.

Preferably, the pressing frame 351 is provided with a plurality of developing points or at least one circle of developing wires. Specifically, a plurality of the developing points are arranged in a circle along the edge of the pressing frame 351; or at least one circle of developing wires is arranged along the edge of the pressing frame 351. The edges are arranged in a circle.

The proximal positioning member 35 further includes a connecting tube 353 sleeved on the adjusting tube 317, and the proximal end of at least one pressing frame 351 is connected to the distal end of the connecting tube 353. After the pressing frame 351 is fully expanded, the pressing frame 351 extends from the distal end to the distal end of the connecting tube 353 and obliquely extends toward the axis line away from the connecting tube 353. The angle between the inclined surface of the pressure frame 351 and the axis of the connecting tube 353 is greater than 0 degrees and less than 90 degrees, preferably between 45 degrees and 60 degrees. The pressing surface 3510 of the leaflet to be cut is pressed, and the pressing surface 3510 enables the pressing frame 351 to effectively and elastically press the proximal end surface of the leaflet to be cut to prevent the leaflet to be cut from moving proximally.

In this embodiment, the proximal end of the connecting tube 353 is connected to the operating handle 70, and the connecting tube 353 is rotatably sleeved on the adjusting tube 317. The operating handle 70 controls the connecting tube 353 to rotate relative to the adjusting tube 317, that is, the connecting tube 353. It rotates relative to the adjusting tube 317 to drive the pressing frame 351 to rotate, so that the pressing frame 351 presses against the leaflets to be cut in different positions. If the valve leaflet cutting system 100 needs to cut three valve leaflets arranged in the aortic valve, the connecting tube 353 rotates 120 degrees relative to the adjusting tube 317 to resist the valve leaflets at different positions; such as the valve leaflet cutting system 100 needs to cut the leaflets of the mitral valve, and the connecting tube 353 rotates 180 degrees relative to the adjusting tube 317 to resist the leaflets in different positions; for example, the leaflet cutting system 100 needs to cut the valve of the tricuspid valve. For each leaf, the connecting tube 353 rotates 120 degrees relative to the adjusting tube 317 to resist the leaflets in different positions.

As shown in Figures 3 and 4, the cutting member 40 includes a cutting wire 41 and a cutting catheter 43 sheathed on the cutting wire 41. The cutting portion 42 is provided at the distal end of the cutting catheter 43, that is, the cutting portion 42 is the distal end of the cutting wire 41. The distal end of the cutting catheter 43 is exposed outside the end; the distal end of the cutting catheter 43 is adjustable, and the distal end of the cutting catheter 43 near the cutting part 42 is provided with an adjustable bending part 431. The cutting catheter 43 can accommodate the cutting guide wire 41 and deliver the cutting guide wire 41 to a treatment location, such as aortic valve, mitral valve, or tricuspid valve leaflet. Specifically, the proximal end of the cutting wire 41 is electrically connected to the ablation power source, and the proximal end of the cutting catheter 43 is connected to the operating handle 70. Through the operation of the operating handle 70, the adjustable bending part 431 of the cutting catheter 43 can be bent or straightened. Therefore, the cutting portion 42 is driven to move between the edge of the valve leaflet to be cut close to the aortic wall and the side away from the aortic wall to cut the valve leaflet to be cut, that is, the cutting portion 42 moves along the radial direction of the aorta. And cut the leaflets to be cut. Specifically, when the cutting portion 42 is placed at a suitable position of the leaflet to be cut, the cutting wire 41 is connected to the ablation power source, and the adjustable bending portion 431 is bent or straightened to move the cutting portion 42 to cut the leaflet to be cut.

By controlling the operating handle 70, the bending angle of the distal end of the cutting catheter 43 can be controlled to be between 0 degrees and 180 degrees; therefore, through the adjustable bending control of the adjustable bending portion 431, the valve leaflet cutting can be determined more accurately The position and angle.

Preferably, the distal end of the cutting catheter 43 is provided with several developing points or at least one circle of developing wire. Further, the cutting part 42 is provided with several developing points or at least one developing wire, and the several developing points extend along the axial direction of the cutting part 42 At least one; at least one developing wire extends along the axial direction of the cutting portion 42.

2 to 4, the valve leaflet cutting device 20 further includes a sheath assembly 50, the sheath assembly 50 includes an inner sheath 52 and an outer sheath 54 sleeved on the inner sheath 52, the connecting tube 353 Axially inserted into the inner sheath 52; when the valve leaflet cutting device 20 is contracted, the positioning frame 311 of the distal positioning member 31 and the compression frame 351 of the proximal positioning member 35 can be compressed and accommodated in the outer sheath 54 , Convenient for transportation; when the valve leaflet cutting device 20 is fully deployed, the distal end positioning member 31 and the proximal end positioning member 35 both extend out of the distal surface of the inner sheath 52 to facilitate positioning of the valve leaflet to be cut. The cutting catheter 43 is arranged in the inner sheath 52 along the axial direction. When the cutting catheter 43 is contracted, the distal end of the cutting catheter 43 can be accommodated in the inner cavity of the outer sheath 54 for convenient transportation; when the cutting catheter 43 is unfolded, the cutting catheter 43 The adjustable bending portion 431 at the distal end extends out of the distal surface of the inner sheath 52 to facilitate the cutting portion 42 to cut the valve leaflets.

In this embodiment, a first channel 522 and a second channel 524 spaced apart from each other are provided in the inner sheath 52 along the axial direction. Preferably, the first channel 522 is located on the axis of the inner sheath 52, and the second channel 524 is located on the first channel. Around a channel 522; the connecting tube 353 and the cutting catheter 43 are inserted in the first channel 522 and the second channel 524, respectively, the connecting tube 353 rotates relative to the inner sheath 52, so that the pressure frame 351 can resist different positions The leaflets to be cut; the cutting member 40 rotates with the inner sheath 52 relative to the connecting tube 353, and the cutting catheter 43 rotates relative to the inner sheath 52, so that the cutting portion 42 cuts the leaflets to be cut at different positions. Preferably, the first channel 522 and the second channel 524 are spaced apart in the radial direction of the inner sheath tube 52, and the connecting tube 353 can slide axially in the first through hole 522 and can rotate relative to the inner sheath tube 52; The sheath 52 can rotate relative to the connecting tube 353, the cutting catheter 43 can slide axially in the second through hole 524, and can rotate relative to the inner sheath 52.

Please refer to FIGS. 5-9 together. FIG. 5 is a three-dimensional assembly view of the valve leaflet cutting device 20 in FIG. 4; FIG. 6 is a cross-sectional view of the valve leaflet cutting device 20 in FIG. 2 along the line VI-VI; FIG. 7 is a diagram Fig. 8 is a schematic diagram of the use state of the leaflet cutting device 20 in Fig. 7 from another perspective; Fig. 9 is a schematic diagram of the leaflet cutting device 20 in Fig. 7 along the IX- Sectional view of line IX. When the valve leaflet cutting system 100 in this application is in use, it needs to be used in conjunction with a conductive pusher, ablation power supply, and power connection line. In this embodiment, the valve leaflet cutting system 100 is already implanted in the aorta 600 The original surgical bioprosthesis valve leaflet 602 is cut as an example, the specific usage method is as follows:

Insert the guide wire into the sinus floor of the original surgical biological valve leaflet 602 at the root of the aorta 600;

The cutting device 20 is placed in a designated position through the guide wire, releasing the distal positioning member 31, and adjusting the radial size of the positioning frame 311 by pulling the adjusting rod 315 proximally, so that the outer periphery of the positioning frame 311 is supported by the aorta 600 The inner wall and the supporting surface 3110 of the positioning frame 311 can prop up the original surgical biological valve leaflet 602 to prevent the valve leaflet 602 from moving distally;

Release the proximal positioning member 35 so that the pressing frame 351 of the proximal positioning member 35 presses against the proximal surface of the valve leaflet 602 of one of the original surgical bioprostheses to prevent the valve leaflet 602 from moving proximally;

Push the cutting portion 42 of the cutting member 40 to the position of the leaflet 602 of one of the original surgical bioprostheses, adjust the bending angle of the adjustable bending portion 431 of the cutting catheter 43, and make the cutting portion 42 approach the valve leaflet 602 At the edge, the cutting wire 41 is connected to the ablation power source, and the cutting portion 42 of the cutting wire 41 is moved, so that the cutting portion 42 cuts the valve leaflet 602 until it is completely separated;

Rotate the pressing frame 351 and the cutting member 40 to make the pressing frame 351 press against the leaflet 602 of another original surgical bioprosthesis, and the cutting part 42 is close to the edge of the leaflet 602 of the other original surgical bioprosthesis to communicate with the ablation power supply , Move the cutting part 42 of the cutting wire 41 so that the cutting part 42 cuts the leaflet 602;

After the cutting is completed, the positioning frame 311, the pressing frame 351 and the adjustable bending portion 431 are all recovered into the outer tube 54, and all the instruments are withdrawn.

In other embodiments, the leaflet cutting system 100 can cut the leaflets of the mitral valve or tricuspid valve by the same method.

The distal end positioning member 31 and the proximal end positioning member 35 of the valve leaflet cutting system 100 in this embodiment clamp together the valve leaflet 602 to be cut, preventing the valve leaflet 602 from moving distally or proximally, and facilitating the cutting portion 42 to the valve leaflet. 602 for cutting. Since the distal end positioning member 31 and the proximal end positioning member 35 can position the leaflet 602 to be cut to prevent the leaflet to be cut 602 from swinging, the cutting part 42 is placed on the leaflet 602 to be cut and cut by moving For the to-be-cut valve leaflet 602, the cut valve leaflet 602 is divided into several pieces. Therefore, the cut valve leaflet 602 will no longer block the coronary ostium, thereby preventing the original surgical biological valve leaflet 602 from being in the transcatheter aortic valve Covering the coronary ostium during the replacement procedure resulted in occlusion.

Please refer to FIG. 10. FIG. 10 is a schematic diagram of the three-dimensional structure of the leaflet cutting device 20 a provided by the second embodiment of the present application. The structure of the valve leaflet cutting system provided by the second embodiment of the present application is similar to the structure of the first embodiment, except that: in the second embodiment, the distal end of the connecting tube 353 is provided with two compression frames 351 along the circumferential direction. , The two pressing frames 351 are used to respectively press the two leaflets to be cut. Specifically, the two pressing frames 351 are symmetrically arranged along the axis of the connecting pipe 353, that is, the included angle between the two pressing frames 251 is 180 degrees. The valve leaflet cutting device 20a in this embodiment is used to cut the valve leaflets of the mitral valve. The connecting tube 353 can be fixed relative to the distal positioning member 31, that is, the connecting tube 353 will not rotate relative to the distal positioning member 31.

The method of using the valve leaflet cutting device 20a provided by the second embodiment of the present application is similar to that of the first embodiment, except that the proximal positioning member 35 is released so that the two pressing frames 351 of the proximal positioning member 35 are respectively pressed against Press the proximal surfaces of the two leaflets of the mitral valve to prevent the two leaflets from moving proximally; the cutting member 40 rotates with the inner sheath 52 relative to the connecting tube 353 to drive the cutting portion 42 to move to a suitable position, thereby It is convenient for the cutting part 42 to cut the leaflets until they are completely separated. It is only necessary to rotate the inner sheath 52 relative to the connecting tube 353 to drive the cutting member 40 to move until the cutting part 42 is close to the edge of the other leaflet, and then control the adjustable bending part. 431 drives the cutting part 42 to move in the radial direction to cut the other leaflet. In this embodiment, the cutting member 40 rotates with the pushing tube 52 relative to the connecting tube 353.

Please refer to FIG. 11. FIG. 11 is a schematic diagram of a three-dimensional structure of a leaflet cutting device 20 b provided by a third embodiment of the present application. The structure of the valve leaflet cutting system provided by the third embodiment of the present application is similar to the structure of the first embodiment, except that: in the third embodiment, the distal end of the connecting tube 353 is provided with more than two pressures along the circumferential direction. Frame 351, two or more pressing frames 351 respectively press against the proximal surfaces of different leaflets to be cut; specifically, the distal end of the connecting tube 353 is provided with three pressing frames 351 along the circumferential direction, and the three pressing frames 351 are respectively Press against the proximal faces of the three leaflets to be cut. Specifically, the three pressing frames 351 are evenly arranged along the circumferential direction of the connecting pipe 353, that is, the angle between two adjacent pressing frames 251 is 120 degrees. The valve leaflet cutting device 20a in this embodiment is used to cut the leaflets of the tricuspid valve. The connecting tube 353 can be fixed relative to the distal positioning member 31, that is, the connecting tube 353 will not rotate relative to the distal positioning member 31.

The method of using the valve leaflet cutting device 20b provided in the third embodiment of the present application is similar to that of the first embodiment, except that the proximal positioning member 35 is released so that the three pressure frames 351 of the proximal positioning member 35 are respectively pressed against Press the proximal surfaces of the three leaflets of the tricuspid valve to prevent the three leaflets from moving proximally; move the cutting portion 42 to cut one leaflet until it is completely separated; only need to pass through the opposite connecting tube 353 Rotate the inner sheath 52 to drive the cutting member 40 to rotate, so that the cutting part 42 is close to the edge of the other leaflet, and then the cutting part 42 is moved by controlling the adjustable bending part 431 to facilitate the cutting part 42 to cut the other leaflet . In this embodiment, the cutting member 40 rotates with the pushing tube 52 relative to the connecting tube 353.

In other embodiments, the distal end of the connecting tube 353 is provided with a plurality of compression frames 351 along the circumferential direction, and the plurality of compression frames 351 are arranged along the circumferential direction of the connection tube 353, and the plurality of compression frames 351 respectively press different leaflets to be cut.

The above is the implementation of the embodiments of the present application. It should be pointed out that for those of ordinary skill in the art, without departing from the principle of the embodiments of the present application, several improvements and modifications can be made, and these improvements and modifications are also Treated as the scope of protection of this application.

Claims

A cutting device, characterized in that the cutting device includes a cutting member and a leaflet positioning mechanism, the distal end of the cutting member is provided with a cutting part, the proximal end of the cutting part is electrically connected to an ablation power source, and the cutting part is used for For cutting leaflets, the leaflet positioning mechanism is used to stabilize the position of the cutting leaflets.
The cutting device according to claim 1, wherein the cutting member comprises a cutting wire and a cutting catheter sheathed on the cutting wire, and the cutting part is a distal end of the cutting wire exposing the distal end of the cutting catheter. End part.
The cutting device according to claim 2, wherein the distal end of the cutting catheter is adjustable, and the bending of the distal end of the cutting catheter makes the cutting part move along the radial direction of the leaflet to be cut to cut The leaflets to be cut.
The cutting device according to claim 3, wherein the distal end of the cutting catheter is provided with an adjustable bending portion, and the bending angle of the adjustable bending portion is between 0 degrees and 180 degrees.
The cutting device according to claim 3, wherein the distal end of the cutting catheter is moved between the edge of the valve leaflet close to the aortic wall and the side away from the aortic wall to cut the valve leaflet.
The cutting device according to claim 1, wherein the valve leaflet positioning mechanism comprises a distal end positioning member, and the distal end positioning member is used to abut against the distal surface of the valve leaflet to be cut.
The cutting device according to claim 6, wherein the valve leaflet positioning mechanism further comprises a proximal end positioning member, the proximal end positioning member being used to press against the proximal end surface of the valve leaflet to be cut.
The cutting device according to claim 7, wherein the proximal end positioning member is provided with at least one point, line or surface that presses against the leaflet to be cut.
The cutting device according to claim 7, wherein the distal end positioning member comprises a positioning frame at the distal end, and the positioning frame is a woven frame or a grid frame that can be elastically expanded and contracted.
The cutting device according to claim 9, wherein the positioning frame is provided with a support surface at the proximal end, and the support surface is used to abut the distal surface of the leaflet to be cut.
The cutting device according to claim 10, wherein the distal end positioning member further comprises an adjusting rod inserted in the middle of the positioning frame along the axial direction and an adjusting tube movably sleeved on the adjusting rod, The positioning frame is located between the distal end of the adjustment rod and the distal end of the adjustment tube, and the relative distance between the distal end of the adjustment rod and the distal end of the adjustment tube is changed to adjust the position of the positioning frame. Radial size.
The cutting device according to claim 11, wherein the distal end of the positioning frame is converged and connected to the adjusting rod, the proximal end of the positioning frame is convergent and connected to the distal end of the adjusting tube, and the The adjusting tube can slide axially relative to the adjusting rod.
The cutting device according to claim 11, wherein the distal end of the positioning frame converges and is fixedly connected to the adjusting rod, and the proximal end of the positioning frame converges and is fixedly connected to the distal end of the adjusting tube The distal movement of the adjustment tube relative to the adjustment rod in the axial direction can increase the radial size of the positioning frame, and the proximal movement of the adjustment tube relative to the adjustment rod in the axial direction can reduce the The radial size of the positioning frame.
The cutting device according to claim 11, wherein the proximal positioning member comprises at least one compression frame, and the compression frame is a single-loop frame, a woven frame or a grid frame that can be contracted.
The cutting device according to claim 14, wherein the proximal positioning member further comprises a connecting tube sleeved on the adjusting tube, and at least one proximal end of the pressure frame is connected to the connecting tube. remote.
The cutting device according to claim 15, wherein the pressing frame extends obliquely from the connecting tube to the distal end and toward the axis line away from the connecting tube.
The cutting device according to claim 15, wherein the connecting tube rotates relative to the adjusting tube to drive the pressing frame to rotate, so that the pressing frame presses against the leaflets to be cut at different positions .
The cutting device according to claim 14, wherein the pressing frame is provided with a plurality of developing points or at least one circle of developing wire; the plurality of developing points are arranged in a circle along the edge of the pressing frame; or At least one circle of developing wires is arranged in one circle along the edge of the pressing frame.
The cutting device according to claim 15, wherein the distal end of the connecting tube is provided with two pressure frames along the circumferential direction, and the two pressure frames respectively press against two leaflets to be cut; or The distal end of the connecting tube is provided with more than two compression frames along the circumferential direction, and the two or more compression frames respectively press against different leaflets to be cut.
The cutting device according to claim 15, further comprising an inner sheath and an outer sheath sheathed in the inner sheath, the connecting tube is inserted into the inner sheath in the axial direction, and The positioning frame of the distal positioning element and the compression frame of the proximal positioning element are compressed and accommodated in the outer sheath.
The cutting device according to claim 20, wherein the cutting catheter is arranged in the inner sheath along the axial direction, and when the cutting catheter is contracted, the distal end of the cutting catheter can be accommodated in the The inner cavity of the outer sheath; when the cutting catheter is deployed, the distal end of the cutting catheter extends out of the distal surface of the inner sheath.
The cutting device according to claim 21, wherein a first channel and a second channel spaced apart from each other are opened in the inner sheath along the axial direction, and the connecting tube and the cutting catheter are inserted into the first channel respectively. In the first channel and the second channel, the connecting tube rotates relative to the inner sheath tube so that the pressure frame presses against the leaflets to be cut in different positions, and the cutting member moves with the inner sheath tube relative to the The connecting pipe rotates to cut the leaflets to be cut at different positions by the cutting part.
A cutting system, characterized in that it comprises the valve leaflet cutting device according to any one of claims 1-22 and an operating handle, the operating handle is provided at the proximal end of the valve leaflet cutting device, and the operating handle The handle is used to control the leaflet positioning mechanism and the cutting part of the leaflet cutting device.