CN116407252A

CN116407252A - Valve cutting device

Info

Publication number: CN116407252A
Application number: CN202111642229.1A
Authority: CN
Inventors: 张伟伟; 韦昭; 彭元丁; 谢惠雄; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2021-12-29
Filing date: 2021-12-29
Publication date: 2023-07-11

Abstract

The invention discloses a valve cutting device. The valve cutting device includes a capture catheter and a cutting member. The catching catheter comprises a catheter body, wherein the catheter body comprises a main body section and an adjustable bending section arranged at the far end of the main body section. The adjustable bend section has a bent state in which the adjustable bend section forms a hook-like structure. The cutting member is of a linear configuration. The cutting member extends along the body section, and the distal end of the cutting member extends out of the tube wall at the distal end of the body section and is fixedly connected with the distal end of the adjustable bend section. The part of the cutting component, which is positioned outside the pipe body, is a movable section, and the movable section synchronously moves along with the adjustable bending section. The movable section comprises a cutting part, and the cutting part is positioned on the concave side of the adjustable bending section in a bending state. According to the valve cutting device, as the cutting member is arranged on the capturing catheter, only one catheter is needed to realize the valve She Zhuabu and cutting, the structure is simple, the operation flow is simplified, and the damage to a patient can be reduced.

Description

Valve cutting device

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a valve cutting device.

Background

Mitral regurgitation (Mitral regurgitation, MR for short) is a common valve disorder that, when severe, affects the health and even endangers life of the patient. Clinically common treatments include mitral valve replacement or mitral valve repair. Among them, the edge-to-edge repair is a common mitral valve repair type, in which the anterior leaflet and the posterior leaflet of the mitral valve are pulled toward each other and sutured to be fixed or connected through a catheter intervention using a valve clip or a clip needle, forming a double-hole structure, reducing or eliminating regurgitation, to improve clinical conditions.

Some patients may develop residual or recurrent reflux after receiving the edge-to-edge repair treatment for a period of time, requiring further treatment to reduce reflux. However, it is not feasible to add a valve clip by way of intervention due to problems such as transvalve differential pressure or potential mitral stenosis, and transcatheter mitral valve replacement (Transcatheter mitral valve replacement, TMVR for short) is generally considered. The double-hole structure formed by edge-to-edge repair prevents the implementation of mitral valve replacement, so that before secondary repair, the anterior leaflet and the posterior leaflet of the mitral valve need to be separated to form a large single-hole structure for placement of the prosthetic mitral valve.

The prior art discloses a cutting device for separating a valve clip from a leaflet for reshaping a mitral valve single orifice structure. The device includes a capturing catheter, a delivery catheter, and a cutting member. In operation, the capture catheter and the delivery catheter are passed through the dual-hole structure of the mitral valve, respectively, the cutting member is deliverable through the delivery catheter to the vicinity of the mitral valve, the distal end of the cutting member is engaged with the distal end of the capture catheter by the magnetic element, and the capture catheter is then pulled back to expose the cutting region of the cutting member to cut tissue around the valve leaflet, thereby separating the valve leaflet from the valve leaflet.

However, such cutting devices employ multiple catheters, requiring the use of a larger diameter sheath to create a passageway from outside the patient's body to inside the body to simultaneously pass through the multiple catheters, and are highly damaging to the patient. Moreover, the capturing catheter, the transmission catheter and the cutting member are required to be sequentially conveyed to the vicinity of the mitral valve respectively, the operation steps are complex and complicated, and the operation is long.

Disclosure of Invention

The present invention aims to solve at least one of the technical problems existing in the prior art. Therefore, the valve cutting device provided by the invention has the advantages that only one catheter is needed to realize the valve She Zhuabu and the cutting, the structure is simple, the operation flow is simplified, and the operation time can be greatly shortened.

The valve cutting device comprises a catching catheter and a cutting member. The catching catheter comprises a catheter body, wherein the catheter body comprises a main body section and an adjustable bending section arranged at the far end of the main body section. The adjustable bend section has a bent state in which the adjustable bend section forms a hook-like structure. The cutting member is of a linear configuration. The cutting member extends along the body section, and the distal end of the cutting member extends out of the tube wall at the distal end of the body section and is fixedly connected with the distal end of the adjustable bend section. The part of the cutting component, which is positioned outside the pipe body, is a movable section, and the movable section synchronously moves along with the adjustable bending section. The movable section comprises a cutting part, and the cutting part is positioned on the concave side of the adjustable bending section in a bending state.

According to the valve cutting device, the capturing catheter and the cutting member are combined together, the capturing function and the cutting function are integrated, and two valve leaflets which are connected together through edge-to-edge repair of a heart valve can be separated, so that a single-hole structure of the natural valve is restored, and repair or replacement therapy is facilitated. Because the cutting member is arranged on the catching catheter, only one catheter is needed to realize the flap She Zhuabu and the cutting, the structure is simple, the operation flow is simplified, and the operation time can be greatly shortened. Meanwhile, as a catheter is adopted, a sheath tube with smaller diameter can be adopted to establish a surgical channel from outside the body of the patient to inside the body of the patient, so that the damage to the patient can be reduced.

In some embodiments, the tube wall of the body section is axially provided with a receiving channel in which the cutting member is partially disposed.

In some embodiments, the capturing catheter further comprises a traction wire, a traction channel penetrating the main body section and the adjustable bending section is arranged on the wall of the catheter body along the axial direction, the traction wire movably penetrates through the traction channel, the distal end of the traction wire is connected with the adjustable bending section, and the traction wire moves in the traction channel so that the adjustable bending section is bent or returns to be straight.

In some embodiments, the tube body includes an outer tube and an inner tube fixedly disposed within the outer tube. The inner tube is a flexible tube, the hardness of the outer tube is greater than that of the inner tube, the hardness of the outer tube at the adjustable bending section is less than that of the outer tube at the main section, and a first gap is formed between the inner tube and the outer tube along the axial direction. Wherein, the accommodating channel and the traction channel are arranged in the first gap.

In some embodiments, the tube body further comprises a reinforcing tube disposed between the inner tube and the outer tube, the reinforcing tube separating the first gap from the inside to the outside into a second gap and a third gap. Wherein, the accommodating channel and the traction channel are both positioned in the second gap or the third gap, or the accommodating channel and the traction channel are positioned in different gaps in the second gap and the third gap.

In some embodiments, the traction channel and the receiving channel are located in a 30 ° sector centered on the central axis in a section of the tube perpendicular to its central axis.

In some embodiments, the capturing catheter comprises two traction wires, the wall of the catheter body is axially provided with two traction channels symmetrically arranged about the central axis of the catheter body, and the accommodating channel is positioned between the two traction channels.

In some embodiments, the capturing catheter further comprises a tapered guide slider, the guide slider is disposed at the distal end of the adjustable bend section, the proximal end of the movable section is fixedly connected or movably connected with the distal end of the main section, and the distal end of the movable section is fixedly connected with the guide slider. In some embodiments, the adjustable bend section also has a flat condition in which the movable section is substantially flat and in close proximity to the adjustable bend section.

In some embodiments, the adjustable bend section has an axial length in the range of 1cm to 5cm, and the cutting portion is correspondingly positioned in an axially intermediate region of the adjustable bend section, the cutting portion having an axial length in the range of 0.5mm to 10mm.

In some embodiments, the cutting member includes a conductive core and an insulating layer wrapped around the conductive core, and the insulating layer on a side of the cutting portion opposite the adjustable bend section is stripped to expose the conductive core. The valve cutting device further includes an energy generator electrically connected to the proximal end of the conductive core.

In some embodiments, the cutting portion is a blade disposed on a side of the movable segment opposite the adjustable bend segment.

In some embodiments, the valve cutting device further comprises a fixed ring, the fixed ring is sleeved outside the capturing catheter, and the adjustable bending section and the movable section are arranged in the fixed ring in a penetrating manner.

In some embodiments, the valve cutting device further comprises an operating handle fixedly connected to the proximal end of the tube, the operating handle for operating the adjustable bend section to a bent state.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Drawings

The foregoing and/or additional aspects and advantages of the invention will become apparent and readily appreciated from the following description of the embodiments, taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of an adjustable curved section of a valve cutting device according to an embodiment of the present invention in a flattened state;

FIG. 2 is an enlarged view at A in FIG. 1;

FIG. 3 is a perspective view of an adjustable curved section of a valve cutting device according to an embodiment of the present invention in a curved state;

fig. 4 is an enlarged view at C in fig. 3;

FIG. 5 is a schematic illustration of the anatomy of the mitral valve after implantation of a valve clip;

FIG. 6 is a schematic illustration of a valve cutting device of the invention of two leaflets Jing Ben joined together via edge-to-edge repair of a heart valve separated into a single orifice;

FIG. 7 is a schematic cross-sectional view of a tubular body of a valve cutting device according to some embodiments of the present invention;

FIG. 8 is a schematic cross-sectional view of a tubular body of a valve cutting device according to further embodiments of the present invention;

FIG. 9 is a schematic cross-sectional view of a tubular body of a valve cutting device according to still other embodiments of the present invention;

FIG. 10 is a schematic cross-sectional view of a tubular body of a valve cutting device according to further embodiments of the present invention;

FIG. 11 is a perspective view of an anchoring ring and traction wire connection of a valve cutting device according to an embodiment of the present invention;

FIG. 12 is an enlarged view at B in FIG. 1;

FIG. 13 is a schematic view of a cutting member of a valve cutting device according to some embodiments of the present invention;

FIG. 14 is a schematic view of a cutting member of a valve cutting device according to further embodiments of the present invention;

FIG. 15 is a perspective view of an adjustable curved section of a valve cutting apparatus according to another embodiment of the present invention in a curved state;

FIGS. 16-18 are schematic views of a process for removing a valve clip from a mitral valve leaflet via a femoral vein access using a valve cutting device;

FIG. 19 is a schematic view of a process for removing a valve clip from a mitral valve leaflet via a transapical approach using a valve cutting device;

fig. 20 is a schematic view of a process for removing a valve clip from a tricuspid leaflet via femoral vein access using a valve cutting device.

Detailed Description

Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals refer to the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary only for explaining the present invention and are not to be construed as limiting the present invention.

The term "proximal" and "distal" are defined in the specification of the present invention as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end that is distal to the operator during a surgical procedure, and "proximal" refers to the end that is proximal to the operator during a surgical procedure; the direction of the rotation central axis of the column body, the tube body and other objects is defined as an axial direction; the circumferential direction is the direction around the axis of the column body, the pipe body and other objects; radial is the direction along the diameter or radius. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs.

Referring to fig. 1-4, a valve cutting device 1 according to an embodiment of the present invention includes a capturing catheter 10 and a cutting member 20. Specifically, the capturing catheter 10 includes a tube 11, the tube 11 including a main body section 12 and an adjustable bend section 13 provided at a distal end of the main body section 12, the adjustable bend section 13 having a bent state in which the adjustable bend section 13 forms a hook-like structure. The cutting member 20 is in a linear structure, the cutting member 20 extends along the main body section 12, the distal end of the cutting member 20 penetrates out of the pipe wall at the distal end of the main body section 12 and is fixedly connected with the distal end of the adjustable bending section 13, the part of the cutting member 20 positioned outside the pipe body 11 is a movable section 21, the movable section 21 moves synchronously with the adjustable bending section 13, the movable section 21 comprises a cutting part 212, and the cutting part 212 is positioned on the concave side of the adjustable bending section 13 in the bending state.

According to the valve cutting device 1 provided by the embodiment of the invention, the capturing catheter 10 and the cutting member 20 are combined together, the capturing function and the cutting function are integrated, and two valve leaflets which are connected together through edge-to-edge repair of a heart valve can be separated, so that the single-hole structure of the natural valve is restored, and the repair or replacement therapy is facilitated. Because the cutting member 20 is arranged on the catching catheter 10, only one catheter is needed to realize the flap She Zhuabu and cutting, the structure is simple, the operation flow is simplified, and the operation time can be greatly shortened. Meanwhile, as a catheter is adopted, a sheath tube with smaller diameter can be adopted to establish a surgical channel from outside the body of the patient to inside the body of the patient, so that the damage to the patient can be reduced.

It will be appreciated that the adjustable bend section 13 has a straight state and a bent state, the adjustable bend section 13 being switchable between the straight state and the bent state. The straight state refers to the fact that the central axis of the adjustable bending section 13 is a straight line, and the bent state refers to the fact that the central axis of the adjustable bending section 13 is an arc line. In the bending angle range of the adjustable bending section 13, the adjustable bending section 13 can be bent to any angle according to the heart anatomy structure to form a hook-shaped structure, so that the valve leaflet can be captured conveniently and can be supported. Since the movable section of the cutting member 20 moves synchronously with the adjustable bend section 13, the movable section 21 bends synchronously with the adjustable bend section 13 from straight to bent or with the adjustable bend section 13 from bent to straight. The adjustable bend section 13 is in a flat condition, the movable section 21 being substantially flat and abutting the adjustable bend section 13. In this way, the radial width of the valve cutting device 1 when delivered can be reduced. In addition, since the cutting member 20 is attached to the body 11 of the capturing catheter 10, it also moves with the movement of the capturing catheter 10.

When the valve cutting device 1 is used, the adjustable bending section 13 bent into a hook shape provides support for the cutting part 212, so that the cutting part 212 positioned on the concave side of the adjustable bending section 13 in the bent state contacts the valve leaflet to cut, thereby separating two valve leaflets connected together through edge-to-edge repair and restoring the single-hole structure of the natural valve.

It should be noted that the cutting member 20 has a linear structure means that the cutting member 20 is an elongated member having a certain axial length. The cutting mode of the cutting portion 212 may be selected from mechanical cutting, electric knife cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic knife cutting, or semiconductor thermosetting knife. The proximal end of the cutting member 20 may be connected to different energy generators according to different cutting patterns, such that the cutting portion 212 may cut the leaflet. The cutting member 20 may extend within the lumen of the body segment 12 or within the wall of the body segment 12 such that the distal end of the cutting member 20 extends out of the wall of the distal end of the body segment 12. The distal end of the body segment 12 is not limited to a distal tip or face, but includes a location extending proximally from the distal tip or face an axial distance, optionally 5cm, for example.

In some embodiments, the adjustable bend angle of the adjustable bend section 13 ranges from 0 ° to 270 °, i.e. the adjustable bend section 13 remains straight at 0 °, and can be adjusted from 0 ° to a maximum angle of 270 °.

Referring to fig. 5 and 6, in some embodiments, the valve cutting device 1 is mainly used for cutting the leaflets of the mitral valve MV or tricuspid valve TV with edge-to-edge repair, so that two leaflets fixed by suturing are separated, or two leaflets connected by clamping the valve clip 2 or a clamping needle are separated, and the two leaflets are changed from a double-hole structure to a single-hole structure. In other embodiments, the valve cutting device 1 may also be used to cut adhesion sites at the leaflet interface of a valve to treat valve stenosis, such as aortic stenosis, mitral stenosis, and the like.

Referring to fig. 7-10, in some embodiments, the capturing catheter 10 further includes a traction wire 14, a traction channel 102 penetrating the main body section 12 and the adjustable bending section 13 is axially provided on the wall of the tube body 11, the traction wire 14 movably penetrates through the traction channel 102, the distal end of the traction wire 14 is connected to the adjustable bending section 13, and the traction wire 14 moves in the traction channel 102 to bend or restore the adjustable bending section 13 to be straight. In this way, the traction wire 14 moves in the traction channel 102 by pulling or releasing the traction wire 14, so that the traction adjustable bending section 13 is completely or restored to be flat, and the operation is simple and convenient.

The traction wire 14 should have a radial cross section as small as possible on the basis of having a certain strength to perform a traction function, so that the diameter of the traction wire 14 is preferably in the range of 0.05mm to 0.25mm. The traction wire 14 may be made of a metal material such as stainless steel, tungsten alloy, cobalt-chromium alloy, nickel-titanium alloy, or the like, or may be made of a polymer material having a certain strength, and the material thereof is not particularly limited. The traction wire 14 is preferably a stainless steel wire with a diameter of 0.25mm.

In some embodiments, the capturing catheter 10 includes two traction wires 14, and correspondingly, two traction channels 102 are axially provided on the wall of the tube body 11, and each traction wire 14 is located in a corresponding traction channel 102. In other embodiments, the wall of the tube 11 is provided with one traction channel 102 along the axial direction, and the two traction wires 14 can share one traction channel 102. Of course, it is also possible to use a traction wire 14 to draw the adjustable bending section 13 to bend or to release the traction force on the traction wire 14 and then to restore the adjustable bending section 13 to a straight state.

Referring to fig. 11, in some embodiments, the capture catheter 10 further includes an anchor ring 142 disposed at the distal end of the pull wire 14, the distal end of the pull wire 14 being connected to the adjustable bend section 13 by the anchor ring 142. Preferably, the anchoring ring 142 is coaxial with the adjustable bend section 13, and the anchoring ring 142 may be heat fused with the adjustable bend section 13. In some embodiments, the distal ends of the two traction wires 14 are respectively fixedly connected with an anchoring ring 142, and the anchoring ring 142 is fixedly sleeved on the adjustable bending section 13. The contact area of the traction wire 14 with the adjustable bending section 13 can be increased by the anchoring ring 142, so that the bending of the adjustable bending section 13 can be better traction. The anchor ring 142 may be made of a metal material or a polymer material, and in some embodiments, the anchor ring 142 is made of a metal such as SUS304 stainless steel. The means by which the traction wire 14 is fixedly attached to the anchoring ring 142 includes, but is not limited to, bonding, welding, hot melt, knotting, and the like.

In addition to the adjustable bend section 13 being pulled by the pulling wire 14, in other embodiments, the adjustable bend section 13 may be bent by electrically heating. Specifically, the adjustable bending section 13 is made of a heat deformation material, and the adjustable bending section 13 can be converted from a straight state to a bending state by electrifying and heating the adjustable bending section 13. It will be appreciated that the adjustable bend section 13 is straight when not energized. The degree of bending of the adjustable bend section 13 is related to the temperature to which it is heated, the higher the temperature the higher the degree of bending. After the heating is stopped by power failure, the adjustable bend section 13 can be restored to a flat state.

Referring to fig. 7-10 and 12, in some embodiments, the tube wall of the main body section 12 is provided with a receiving channel 104 along the axial direction, and the cutting member 20 is partially disposed through the receiving channel 104. In this manner, the cutting member 20 is prevented from being disturbed by other structures in the wall of the body section 12. It is understood that the cutting member 20 may be fixedly or movably coupled to the receiving channel 104. The movable section 21 passes through the far end of the accommodating channel 104 and is positioned outside the pipe body 11, and the far end of the movable section 21 is fixedly connected with the far end of the adjustable bending section 13. When the cutting member 20 is fixedly connected with the receiving channel 104 of the receiving channel 104, the length of the movable section 21 is such that the movable section 21 is in close contact with the adjustable bending section 13 without redundancy. When the cutting member 13 is movably connected with the accommodating channel 104, the cutting member 20 can be pulled to tighten the movable section 21 thereof, so as to cut the valve leaflet.

Referring to fig. 7, in some embodiments, the tube 11 includes an outer tube 112 and an inner tube 114 fixedly disposed within the outer tube 112. The inner tube 114 is a flexible tube, the outer tube 112 has a hardness greater than the hardness of the inner tube 114, and the outer tube 112 has a hardness at the adjustable bend section 13 that is less than the hardness of the outer tube 112 at the main section 12, with a first gap 110 being formed axially between the inner tube 114 and the outer tube 112. Wherein the receiving channel 104 and the pulling channel 102 are disposed in the first gap 110. Thus, the tube 11 includes a double tube, and the receiving channel 104 and the pulling channel 102 are disposed between the outer tube 112 and the inner tube 114, so that the receiving channel 104 and the pulling channel 102 are buried in the wall of the tube 11.

It will be appreciated that the inner tube 114 is a flexible tube such that the inner tube 114 is easily bent, the outer tube 112 has a hardness greater than that of the inner tube 114 such that the outer tube 112 provides support for the tube body 11, protecting the tube body 11, and the outer tube 112 has a hardness at the adjustable bend section 13 that is less than the hardness of the outer tube 112 at the main body section 12 such that the hardness of the outer tube 112 does not affect the bending of the adjustable bend section 13 while providing protection to the tube body 11. The inner tube 114 may be made of a flexible material such as Polytetrafluoroethylene (PTFE), and the outer tube 112 may be made of a material having a certain hardness such as polyether block Polyamide (PEBAX). In some embodiments, the inner tube 114 and the outer tube 112 may be formed together by hot melt compounding to form at least one lumen extending completely through the proximal end to the distal end.

Further, referring to fig. 8-10, the tube body 11 further includes a reinforcing tube 116, the reinforcing tube 116 being disposed between the inner tube 114 and the outer tube 112, the reinforcing tube 116 separating the first gap 110 into a second gap 1102 and a second gap 1104 from inside to outside. Wherein, as shown in fig. 8 and 9, the receiving channel 104 and the pulling channel 102 are both located in the second gap 1102 or the second gap 1104; or as shown in fig. 10, the receiving channel 104 and the pulling channel 102 are located in different ones of the second gap 1102 and the second gap 1104. Therefore, the device can be arranged according to actual needs, and the diversity of structural arrangement is increased.

It will be appreciated that the PI or PTFE tubing may be embedded in the second gap 1102 between the inner tube 114 and the reinforcing tube 116 or the second gap 1104 between the reinforcing tube 116 and the outer tube 112 to form the traction channel 102; the PI or PTFE tubing may also be embedded in the second gap 1102 between the inner tube 114 and the reinforcing tube 116 or the second gap 1104 between the reinforcing tube 116 and the outer tube 112 to form the receiving channel 104. Preferably, both the traction channel 102 and the receiving channel 104 are located in the second gap 1102.

The reinforcement tube 116 has a certain rigidity and is capable of being bent in the axial direction, thereby providing support for the tube body 11, avoiding torsional deformation of the tube body 11 in the radial direction, and at the same time not affecting the bending of the adjustable bending section 13. In some embodiments, the reinforcing tube 116 is a metal braided mesh structure braided with a material such as stainless steel wire, tungsten wire, or nickel titanium wire. The inner tube 114, the reinforcing tube 116, and the outer tube 112 may be formed together by hot melt compounding.

Referring to fig. 7-10, in some embodiments, in a cross-section of the tube 11 perpendicular to its central axis, the traction channel 102 and the receiving channel 104 are located in a 30 ° sector centered on the central axis. In this way, the cutting part 212 on the movable section 21 can cut the valve leaflet while the cutting part 212 is bent along with the adjustable bending section 13 when the adjustable bending section 13 is bent by the traction wire 14.

In some embodiments, the capturing catheter 10 includes two traction wires 14, the wall of the tube body 11 is axially provided with two traction channels 102 symmetrically arranged about the central axis of the tube body 11, and the receiving channel 104 is located between the two traction channels 102. In this way, the cutting member 20 is positioned in the middle of the two traction wires 14, and after bending, the cutting member can fully contact the valve leaflet, so that the cutting effect is ensured.

Referring to fig. 2, in some embodiments, the capturing catheter 10 further includes a tapered guide slider 15, where the guide slider 15 is disposed at the distal end of the adjustable bend section 13, the proximal end of the movable section 21 is fixedly connected or movably connected to the distal end of the main body section 12, and the distal end of the movable section 21 is fixedly connected to the guide slider 15. In this manner, tapered slider 15 facilitates the introduction of capture catheter 10 into a blood vessel or tissue lumen.

It will be appreciated that the proximal end of the movable section 21 is fixedly connected to the distal end of the main body section 12, and that the movable section 21 does not enter the main body section 12 even if the cutting member 20 is pulled proximally; the proximal end of the movable section 21 is movably connected to the distal end of the main body section 12, i.e. the cutting member 20 is pulled proximally, and the movable section 21 may partially enter the main body section 12. The distal end of the movable section 21 can be linear, and is fixed on the guide slider 15 in a wrapping manner, so that the connection is stable. The distal end of the movable section 21 can also be in a spiral structure, and is fixedly sleeved on the guide slider 15. Of course, the helical structure of the distal end of the movable section 21 may also be fixed by being sleeved between the outer tube 112 and the reinforcing tube 116.

In some embodiments, a radiopaque imaging ring, such as a tantalum ring, is provided at the proximal end of the guide slider 15 to allow for accurate knowledge of the arrival of the distal end of the capture catheter 10 at a given location under the imaging device.

In some embodiments, the adjustable bend section 13 has an axial length ranging from 1cm to 5cm, the cutting portion 212 is correspondingly located in an axially middle region of the adjustable bend section 13, and the cutting portion 212 has an axial length ranging from 0.5mm to 10mm. In this way, the length of the cutting portion 212 is ensured to cut the tissue while ensuring that the curvature of the adjustable bend section 13 in the bent state is able to catch the tissue. Preferably, the adjustable bend section 13 has an axial length of 3cm and the cutting portion 212 has a length of 2mm. When the adjustable bending section 13 is in a straight state, the length of the movable section 21 is approximately equal to the axial length of the adjustable bending section 13, so that the length of the movable section 21 is prevented from affecting the bending of the adjustable bending section 13.

Referring to fig. 13 and 14, in some embodiments, the cutting member 20 includes a conductive core 214 and an insulating layer 216 surrounding the conductive core 214. The insulating layer 216 of the cut portion 212 on the side opposite to the adjustable bend section 13 is stripped to expose the conductive core 214. The valve cutting device 1 further comprises an energy generator electrically connected to the proximal end of the conductive core 214 of the cutting member 20. In this way, the side of the cutting portion 212 facing away from the adjustable bend section 13 exposes the conductive core 214 such that the conductive core 214 contacts the leaflet to energize the leaflet to cut. In addition, the insulating layer 216 on the side of the cutting portion 212 facing the adjustable bending section 13 remains, so that current dispersion can be avoided to ensure the cutting effect, and current heating and melting of the adjustable bending section 13 can be avoided.

The cutting portion 212 is cut by an electric knife, preferably by an rf electric knife, and the energy generator is an rf generator electrically connected to the conductive core 214. In the cutting process, high-frequency current is transmitted through the conductive core 214, so that positive and negative ions of charges of the valve She Zhongdai around the cutting part 212 generate high-speed oscillation motion, and a large amount of heat is generated by the high-speed oscillation ions due to friction, so that the temperature in the valve leaf is increased, finally, proteins in cells are denatured, water in the cells and the valve leaf is lost, and coagulation necrosis occurs to the valve leaf, thereby realizing radio-frequency cutting. The working frequency range of the radio frequency generator is 1500 KHz-4500 KHz, the skin effect of the current is strong, accidents such as burn and the like can be avoided, and the thermal damage to the valve leaflet is small. It will be appreciated that when other means of electrotome cutting, laser cutting, electromagnetic cutting, microwave cutting, ultrasonic blade cutting, or semiconductor thermocoagulation blade cutting are employed, a corresponding energy generator should be employed in electrical connection with the proximal end of the conductive core 214.

In some embodiments, the cutting portion 212 is a blade provided on a side of the movable section 21 opposite the adjustable bend section 13. In this way, the side of the cutting portion 212 facing away from the adjustable bend section 13 is provided with a blade such that the blade contacts the leaflet to cut the leaflet by mechanical cutting.

Referring to fig. 15, in some embodiments, the valve cutting device 1 further includes a fixing ring 30, the fixing ring 30 is sleeved outside the capturing catheter 10, and the adjustable bending section 13 and the movable section 21 are disposed through the fixing ring 30. In this way, the movable section 21 can be tightly attached to the adjustable bending section 13 by the fixing ring 30, and the cutting effect of the cutting portion 212 is ensured. In some embodiments, the fixing ring 30 is made of an insulating material, the fixing ring 30 is fixedly sleeved on the adjustable bending section 13, and the fixing ring 30 is in contact with the non-cutting portion of the movable section 21. Of course, the fixed ring 30 can also be movably sleeved on the adjustable bending section 13, and the fixed ring 30 is in clearance fit with the adjustable bending section 13 and the movable section 21, so that the fixed ring 30 is prevented from sliding away from the adjustable bending section 13.

Referring to fig. 1 and 3, in some embodiments, the valve cutting device 1 further includes an operating handle 40, where the operating handle 40 is fixedly connected to the proximal end of the tube 11, and the operating handle 40 is used to operate the adjustable bending section 13 to a bending state. In this way, the adjustable bending section 13 is conveniently controlled to adjust the bending by operating the handle 40.

It will be appreciated that when the adjustable bend section 13 is bent using the pull wire 14, the operating handle 40 is provided with a bend adjustment knob to which the proximal end of the pull wire 14 is connected, such that the pull wire 14 can be operated to bend or restore flatness by pulling the adjustable bend section 13. When the adjustable bending section 13 is bent by adopting an electric heating mode, the operating handle 40 is provided with an electric heating switch, and the adjustable bending section 13 is electrically connected through a wire.

Referring to fig. 16-18, the process of removing the valve clip 2 from the leaflets of the mitral valve MV via the femoral vein access by the valve cutting device 1 is described below.

First, the valve cutting device 1 is advanced through the introducer sheath into the left atrium LA above the mitral valve MV, aligning one of the side valve holes E, and the valve cutting device 1 is pushed from the valve hole E into the left ventricle LV to a suitable distance.

The capture catheter 10 is then controlled by operating the handle 40 to adjust the bend to the appropriate angle so that the distal end of the capture catheter 10 is aligned with the other side valve orifice F, and the valve cutting device 1 is pulled back to hook the leaflets so that the conductive core 214 of the cutting portion 212 contacts the tissue surrounding the valve clip 2.

Then, the valve leaflet is cut by electrotome radio frequency cutting until the valve clip 2 is separated from the anterior leaflet AML or the posterior leaflet PML, and a large single hole structure is reformed, so that the patient can receive interventional valve replacement treatment. It is generally preferred to cut the anterior leaflet AML such that the valve clip 2 is separated from the anterior leaflet AML, the valve clip 2 being attached to the posterior leaflet PML to avoid obstruction of the aortic outflow tract.

Referring now to fig. 19, after the valve cutting device 1 enters the left ventricle LV through the transapical puncture sheath, the capturing catheter 10 enters the left atrium LA through the one side valve hole E, the distal end of the capturing catheter 10 is aligned with the other side valve hole F after the capturing catheter 10 is bent by the operation handle 40, and the valve cutting device 1 is pulled back so that the conductive core 214 of the cutting portion 212 contacts the tissue around the valve clip 2 to perform the leaflet cutting.

With reference to fig. 20, the excision of the valve clip 2 between the anterior leaflet ATL and the septal leaflet of the implant tricuspid valve TV will be described. The valve cutting device 1 enters the right atrium through the guiding sheath, the catching catheter 10 enters from the valve hole X, the valve hole Y is aligned after bending, and the valve leaflet is pulled back, so that the conductive core 214 of the cutting part 212 contacts the tissue around the valve clip 2 to cut the valve leaflet.

In the description of the present invention, it should be understood that the terms "upper", "lower", "left", "right", "inner", "outer", "axial", "radial", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention. Furthermore, features defining "first", "second" may include one or more such features, either explicitly or implicitly. In the description of the present invention, unless otherwise indicated, the meaning of "a plurality" is two or more.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

In the description of the present specification, reference to the terms "certain embodiments," "some embodiments," "illustrative embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiments or examples is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

While embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that: many changes, modifications, substitutions and variations may be made to the embodiments without departing from the spirit and principles of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A valve cutting device, comprising:

the capturing catheter comprises a catheter body, wherein the catheter body comprises a main body section and an adjustable bending section arranged at the far end of the main body section, the adjustable bending section is in a bending state, and in the bending state, the adjustable bending section forms a hook-shaped structure; and

the cutting member is of a linear structure, the cutting member extends along the main body section, the distal end of the cutting member penetrates out of the pipe wall at the distal end of the main body section and is fixedly connected with the distal end of the adjustable bending section, the part of the cutting member, which is positioned outside the pipe body, is a movable section, the movable section synchronously moves along with the adjustable bending section, the movable section comprises a cutting part, and the cutting part is positioned on the concave side of the adjustable bending section in the bending state.

2. The valve cutting device of claim 1, wherein a tube wall of the body section is axially provided with a receiving channel, the cutting member partially penetrating the receiving channel.

3. The valve cutting device of claim 2, wherein the capture catheter further comprises a traction wire, wherein a traction channel is axially provided through the body section and the adjustable bend section on the wall of the catheter body, the traction wire movably passes through the traction channel, the distal end of the traction wire is connected to the adjustable bend section, and the traction wire moves in the traction channel to bend or restore to a straight shape of the adjustable bend section.

4. The valve cutting device of claim 3, wherein the tube body comprises an outer tube and an inner tube fixedly disposed therein, the inner tube being a flexible tube, the outer tube having a hardness greater than the hardness of the inner tube, the outer tube having a hardness at the adjustable bend section that is less than the hardness of the outer tube at the main section, a first gap being formed axially between the inner tube and the outer tube;

wherein, the accommodating channel and the traction channel are arranged in the first gap.

5. The valve cutting device of claim 4, wherein the tube body further comprises a reinforcement tube disposed between the inner tube and the outer tube, the reinforcement tube separating the first gap from inside to outside into a second gap and a third gap;

wherein the receiving channel and the traction channel are both located in the second gap or the third gap, or the receiving channel and the traction channel are located in different gaps of the second gap and the third gap.

6. The valve cutting device of any one of claims 3-5, wherein the traction channel and the receiving channel are located in a 30 ° sector centered on the central axis in a cross-section of the tube perpendicular to the central axis.

7. The valve cutting device of claim 6, wherein the capture catheter comprises two traction wires, wherein two traction channels are axially formed in the wall of the catheter body and are symmetrically arranged about the central axis of the catheter body, and the receiving channel is located between the two traction channels.

8. The valve cutting device of claim 1, wherein the capture catheter further comprises a tapered slider guide disposed at the distal end of the adjustable curved section, the proximal end of the movable section being fixedly or movably connected to the distal end of the main section, the distal end of the movable section being fixedly connected to the slider guide.

9. The valve cutting device of claim 1, wherein the adjustable curved section further has a flat condition in which the movable section is substantially flat and in close proximity to the adjustable curved section.

10. The valve cutting device of claim 1, wherein the adjustable bend section has an axial length in the range of 1cm-5cm, the cutting portion is correspondingly located in an axially intermediate region of the adjustable bend section, and the cutting portion has an axial length in the range of 0.5mm-10mm.

11. The valve cutting device of claim 1, wherein the cutting member comprises a conductive core and an insulating layer wrapped around the conductive core, the insulating layer on a side of the cutting portion opposite the adjustable bend section being stripped to expose the conductive core, the valve cutting device further comprising an energy generator electrically connected to a proximal end of the conductive core.

12. The valve cutting device of claim 1, wherein the cutting portion is a blade disposed on a side of the movable segment opposite the adjustable curved segment.

13. The valve cutting device of claim 1, further comprising a retaining ring, the retaining ring being sleeved outside the capture conduit, the adjustable bend section and the movable section being threaded into the retaining ring.

14. The valve cutting device of claim 1, further comprising an operating handle fixedly connected to the proximal end of the tube, the operating handle for operating the adjustable bend section in the bent state.