WO2021227856A1 - Dispositif de coupe et système de coupe - Google Patents

Dispositif de coupe et système de coupe Download PDF

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Publication number
WO2021227856A1
WO2021227856A1 PCT/CN2021/089929 CN2021089929W WO2021227856A1 WO 2021227856 A1 WO2021227856 A1 WO 2021227856A1 CN 2021089929 W CN2021089929 W CN 2021089929W WO 2021227856 A1 WO2021227856 A1 WO 2021227856A1
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WO
WIPO (PCT)
Prior art keywords
cutting
distal end
cut
frame
positioning
Prior art date
Application number
PCT/CN2021/089929
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English (en)
Chinese (zh)
Inventor
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
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Application filed by 杭州德诺睿华医疗科技有限公司 filed Critical 杭州德诺睿华医疗科技有限公司
Publication of WO2021227856A1 publication Critical patent/WO2021227856A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body

Definitions

  • 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.
  • 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.
  • 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.
  • 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.
  • the purpose of the present application is to provide a cutting device and a cutting system capable of cutting valve leaflets.
  • 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.
  • the original leaflet 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.
  • 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;
  • FIG. 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.
  • 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.
  • 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 are used to cut.
  • the cutting part 42 in the present application is a tip that is electrically connected to the ablation power source.
  • 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.
  • the cutting portion 42 can more accurately determine the position and angle of the leaflet cutting.
  • 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.
  • 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.
  • 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.
  • 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.
  • the aortic valve of the valve leaflet to be cut is expanded. It can be radially supported on the inner wall of the aorta.
  • 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.
  • the cross-section passing through the axis of the positioning frame 311 is prismatic.
  • the positioning frame 311 when the distal positioning member 31 is completely released, is generally a conical frame.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 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.
  • 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 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.
  • 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.
  • 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.
  • 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.
  • a number of developing points are provided on the positioning frame 311, and the developing points are fixed by inlay and hot pressing.
  • 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.
  • 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.
  • 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.
  • 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.
  • the proximal positioning member 35 includes at least one compression frame 351.
  • the compression frame 351 is a single-loop frame, a woven frame, or a grid frame that can be expanded and contracted.
  • 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.
  • 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.
  • the pressing frame 351 is provided with a plurality of developing points or at least one circle of developing wires.
  • 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.
  • 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.
  • 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.
  • the connecting tube 353 rotates 120 degrees relative to the adjusting tube 317 to resist the leaflets in different positions.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the distal end of the cutting catheter 43 is provided with several developing points or at least one circle of developing wire.
  • 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.
  • 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 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
  • the cutting catheter 43 is arranged in the inner sheath 52 along the axial direction.
  • 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.
  • 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.
  • the first channel 522 is located on the axis of the inner sheath 52
  • the second channel 524 is located on the first channel.
  • 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 cutting member 40 rotates with the inner sheath 52 relative to the connecting tube 353
  • 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.
  • 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.
  • 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.
  • the valve leaflet cutting system 100 in this application it needs to be used in conjunction with a conductive pusher, ablation power supply, and power connection line.
  • 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:
  • 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;
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 .
  • the cutting member 40 rotates with the pushing tube 52 relative to the connecting tube 353.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Public Health (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif de coupe (20), comprenant un élément de coupe (40) et un mécanisme de positionnement de feuillet valvulaire (30). L'élément de coupe (40) est pourvu d'une section de coupe (42) au niveau d'une extrémité distale, et la section de coupe (42) est électriquement connectée à une alimentation électrique d'ablation au niveau d'une extrémité proximale ; la section de coupe (42) est utilisée pour couper un feuillet valvulaire ; et le mécanisme de positionnement de feuillet valvulaire (30) est utilisé pour stabiliser la position du feuillet valvulaire coupé. Du fait que le mécanisme de positionnement de feuillet valvulaire (30) est capable de stabiliser la position du feuillet valvulaire coupé, la partie coupe (42) est placée sur un feuillet valvulaire à découper et forme une découpe radiale sur le feuillet valvulaire découpé par déplacement. Le feuillet valvulaire découpé se divise et forme une ouverture au niveau d'une artère coronaire, et peut pousser un feuillet valvulaire d'origine lorsqu'une valve cardiaque transcathéter est implantée. Par conséquent, le feuillet valvulaire découpé ne bloque pas l'orifice d'artère coronaire et empêchera le feuillet valvulaire d'origine de recouvrir l'orifice d'artère coronaire pendant le remplacement de valve aortique transcathéter et de provoquer le blocage. L'invention concerne également un système de coupe (100) fourni avec le dispositif de coupe (20).
PCT/CN2021/089929 2020-05-09 2021-04-26 Dispositif de coupe et système de coupe WO2021227856A1 (fr)

Applications Claiming Priority (2)

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CN202010390184 2020-05-09

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102985018A (zh) * 2010-06-22 2013-03-20 勒梅特微管股份有限公司 跨线瓣膜刀
US9642705B2 (en) * 2011-11-15 2017-05-09 Boston Scientific Scimed Inc. Bond between components of a medical device
CN106714714A (zh) * 2014-06-05 2017-05-24 奥蒂科勒勃有限责任公司 用于从主动脉瓣膜小叶消融钙化组织的经导管设备
US20170143330A1 (en) * 2014-03-17 2017-05-25 Evalve, Inc. Mitral valve fixation device removal devices and methods
CN207871029U (zh) * 2017-10-24 2018-09-18 杭州启明医疗器械有限公司 一种介入心脏瓣膜的可调弯输送系统
CN110314016A (zh) * 2018-03-30 2019-10-11 康迪泰科(北京)医疗科技有限公司 一种瓣膜输送装置及其输送系统
CN211934206U (zh) * 2019-12-30 2020-11-17 杭州德晋医疗科技有限公司 瓣膜组织切割装置及瓣膜夹钳回收系统
CN212630960U (zh) * 2020-05-22 2021-03-02 杭州德晋医疗科技有限公司 瓣膜扩张器及瓣膜扩张系统

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102985018A (zh) * 2010-06-22 2013-03-20 勒梅特微管股份有限公司 跨线瓣膜刀
US9642705B2 (en) * 2011-11-15 2017-05-09 Boston Scientific Scimed Inc. Bond between components of a medical device
US20170143330A1 (en) * 2014-03-17 2017-05-25 Evalve, Inc. Mitral valve fixation device removal devices and methods
CN106714714A (zh) * 2014-06-05 2017-05-24 奥蒂科勒勃有限责任公司 用于从主动脉瓣膜小叶消融钙化组织的经导管设备
CN207871029U (zh) * 2017-10-24 2018-09-18 杭州启明医疗器械有限公司 一种介入心脏瓣膜的可调弯输送系统
CN110314016A (zh) * 2018-03-30 2019-10-11 康迪泰科(北京)医疗科技有限公司 一种瓣膜输送装置及其输送系统
CN211934206U (zh) * 2019-12-30 2020-11-17 杭州德晋医疗科技有限公司 瓣膜组织切割装置及瓣膜夹钳回收系统
CN212630960U (zh) * 2020-05-22 2021-03-02 杭州德晋医疗科技有限公司 瓣膜扩张器及瓣膜扩张系统

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