Transcatheter leaflet cutting device and system

Abstract

The present application relates to a kind of transcatheter leaflet cutting device and system, the device includes remote cutting part, catheter part and with the proximal end of the catheter part is connected with proximal operating handle;The remote cutting part is used to clamp and cut leaflet tissue;The catheter part includes inner sheath, middle sheath and adjustable bending outer sheath in turn from inside to outside;The proximal operating handle is integrated with: control bending part, for controlling the bending angle of the outer sheath remote end;Middle sheath locking part, for selectively locking the movement of middle sheath relative to the proximal operating handle;Cutting knife locking part, for selectively locking or unlocking the axial movement of cutting knife arranged in remote cutting part.

Description

Technical Field

[0001] This invention relates to the field of medical devices for cardiac surgery, and more particularly to a transcatheter valve leaflet cutting device and system. Background Technology

[0002] Before transcatheter heart valve replacement surgery, the original autologous valve leaflets or deteriorated bioprosthetic valve leaflets may be pushed into the coronary artery ostium or left ventricular outflow tract, leading to serious complications such as coronary artery obstruction or left ventricular outflow tract obstruction. To address this issue, valve remodeling techniques have been developed clinically. These techniques involve pre-cutting the potentially obstructive valve leaflets before implanting a new valve, thus creating a pathway for blood flow.

[0003] Currently, leaflet cutting instruments require an adjustable bend delivery system to deliver the distal cutting head to the target position and precisely control it to clamp and cut the leaflet. This process relies on the operator's precise multi-dimensional control of the distal cutting head via a proximal control handle, including forward and backward movement, rotation, and adjustment of the bend angle. Therefore, the structure of the control handle directly affects the ease of operation, control precision, and final treatment outcome.

[0004] There are various designs for the control handles of existing leaflet cutting instruments. Some designs adopt a segmented design, with bending control and cutting control set in two separate control handles and connected by a conduit. Other designs adopt an integrated coaxial structure design, with the bending control function set at the front end of the handle and the cutting control function set at the rear end of the handle.

[0005] However, the existing structural designs generally suffer from excessively long control handles, making them incompatible with the widely used 2.6-meter standard guidewire delivery length, thus limiting the instrument's versatility and applicability. Furthermore, segmented or complex integrated handles require operators to coordinate multiple control units simultaneously during surgery, increasing operational complexity and learning costs. The gaps in connection and transmission between components also result in poor control precision, making it difficult to meet the demands of precise adjustments to the cutting head. This operational difficulty and lack of precision caused by the handle design directly increases the overall risk and cost of surgery, hindering its clinical promotion and application. Summary of the Invention

[0006] This invention discloses a transcatheter valve leaflet cutting device and system, aiming to solve the technical problems existing in the prior art. The invention adopts the following technical solution: On one hand, embodiments of the present invention provide a transcatheter valve leaflet cutting device, including a distal cutting section, a catheter section, and a proximal operating handle connected to the proximal end of the catheter section; The distal cutting section is used to clamp and cut the leaflet tissue; the catheter section includes, from the inside out, an inner sheath, a middle sheath, and an adjustable outer sheath. The proximal control handle integrates: The bending control section is used to control the bending angle of the distal end of the outer sheath. The middle sheath locking part is used to selectively lock the movement of the middle sheath relative to the proximal operating handle; The cutting blade locking part is used to selectively lock or unlock the axial movement of the cutting blade located at the distal cutting part.

[0007] As a preferred technical solution, the distal cutting section is also equipped with a main body and a clamping arm; The proximal end of the main body is connected to the inner sheath. The clamping arm is rotatably connected to the main body, and the proximal end of the clamping arm is also drivenly connected to the distal end of the middle sheath tube. The axial movement of the middle sheath tube is used to control the opening and closing of the clamping arm. A control lever is connected to the proximal end of the cutting blade. The control lever passes through the inner sheath and is connected to the locking part of the cutting blade.

[0008] As a preferred technical solution, the outer sheath tube has a traction wire inside its wall. The distal end of the traction wire is fixed inside the wall of the outer sheath tube, and the proximal end of the traction wire extends to the bending control section. The bending control section is used to control the axial movement of the traction wire to adjust the bending angle of the distal end of the outer sheath tube.

[0009] As a preferred technical solution, the bending control part is located at the distal end of the proximal operating handle and extends outward at an angle relative to the central axis of the proximal operating handle.

[0010] As a preferred technical solution, the bending control part includes a rotating operating component, a threaded moving component, and a traction wire fixing component; The threaded moving part and the rotating operating part are threadedly engaged. The rotating operating part is rotatably mounted on the far end of the main body of the near-end operating handle. The rotation of the rotating operating part can drive the threaded moving part and the traction wire fixing part to move axially, so as to pull the traction wire to achieve bending.

[0011] As a preferred technical solution, the traction wire passes through the threaded moving member and connects to the traction wire fixing member, with the distal end of the traction wire fixing member abutting against the proximal end of the threaded moving member; the traction wire fixing member is configured as follows: When the threaded moving part moves towards the proximal end, it pushes the traction wire fixing part to move towards the proximal end simultaneously, so as to pull the traction wire and bend the distal end of the outer sheath tube. When the threaded moving part moves to the distal end, the traction wire fixing part is passively moved to the distal end under the elastic restoring force of the outer sheath.

[0012] As a preferred technical solution, the locking part of the middle sheath tube is coaxially arranged with the central axis of the proximal operating handle; The locking part of the middle sheath includes a knob and a clamping member; the knob is rotatably mounted on the distal body of the proximal operating handle, and the clamping member is driven to engage with the knob; the rotation of the knob can drive the clamping member to retract radially to limit the middle sheath in the axial and circumferential directions, or to expand radially to release the middle sheath.

[0013] As a preferred technical solution, the clamping member is a tubular structure, its outer peripheral surface is configured as a tapered surface that gradually tapers along the axial direction, and its sidewall is provided with multiple openings that extend along the axial direction and are arranged at intervals in the circumferential direction. The distal body of the proximal operating handle is provided with a tapered hole that matches the outer peripheral surface of the clamping member; The rotation of the knob can drive the clamping part to move axially within the tapered hole, and the engagement of the tapered surface forces the clamping part to contract radially.

[0014] As a preferred technical solution, the cutting blade locking part is located at the proximal end of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The cutting blade locking part includes a locking member, which is connected to the proximal end of the control lever, and the outer periphery of the locking member is provided with at least one protrusion; The proximal body of the proximal operating handle is provided with a guide groove that mates with the protrusion. The guide groove includes a first circumferential section, an axial section, and a second circumferential section that are connected sequentially from the proximal end to the distal end. The protrusion can enter the guide groove from the first circumferential section, move to the distal end along the axial section to the second circumferential section, and after circumferential rotation in the second circumferential section, achieve axial locking of the locking member relative to the proximal operating handle.

[0015] As a preferred technical solution, the outer periphery of the locking member is provided with two protrusions symmetrically in the circumferential direction, and the inner body of the proximal operating handle is provided with two guide grooves symmetrically in the circumferential direction.

[0016] As a preferred technical solution, the middle part of the proximal operating handle is also provided with a middle sheath adjustment knob and a middle sheath fixing component; The middle sheath fixing component is connected to the proximal end of the middle sheath; the middle sheath adjusting knob is rotatably mounted on the proximal body of the proximal operating handle and is threadedly engaged with the middle sheath fixing component. The rotation of the middle sheath adjusting knob can drive the axial movement of the middle sheath fixing component, thereby causing the middle sheath to move axially relative to the inner sheath.

[0017] On the other hand, embodiments of the present invention also provide a transcatheter leaflet cutting system, including the transcatheter leaflet cutting device as described in any of the above.

[0018] One embodiment of the above invention has the following advantages or beneficial effects: This invention primarily provides a transcatheter valve cutting device, employing a proximal operating handle integrating a bending control section, a middle sheath locking section, and a cutting blade locking section. This integrated structure enables precise control of multiple degrees of freedom. Specifically, the bending control section, through the cooperation of a rotating operating component and a threaded moving component, can precisely control the tension of the traction wire, achieving fine adjustment of the bending angle. The middle sheath locking section, through the threaded engagement of a knob and a clamping component, can lock or release the middle sheath at any time during surgery, improving the stability of clamping and cutting operations. The cutting blade locking section, through the cooperation of a protrusion on the locking component and a guide groove, reliably locks the cutting blade in the transport state to ensure safety, and can quickly unlock in the cutting state to achieve axial movement of the blade head. Compared to the segmented control handles in existing technologies, this integrated control handle structure of the present invention has a higher degree of integration and a shorter overall length, effectively overcoming the problems of large connection gaps and inconvenient control associated with segmented handles. This allows the surgeon to make more precise adjustments to the position and posture of the distal cutting section, reducing the difficulty and risk of surgical operations. Attached Figure Description

[0019] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below, forming part of the present invention. The illustrative embodiments of the present invention and their descriptions explain the present invention and do not constitute an improper limitation of the present invention. In the accompanying drawings: Figure 1 This is a schematic diagram of the transcatheter valve leaflet cutting device disclosed in one embodiment of the present invention; Figure 2 for Figure 1 A magnified view of a section at point A in the middle; Figure 3 This is a schematic diagram of the structure of a cutting blade disclosed in one embodiment of the present invention; Figure 4 This is a schematic diagram of the internal structure of the outer sheath tube disclosed in one embodiment of the present invention; Figure 5 This is a schematic diagram of the proximal operating handle disclosed in one embodiment of the present invention; Figure 6 This is a cross-sectional view of the proximal operating handle disclosed in one embodiment of the present invention; Figure 7 This is a schematic diagram of the structure of the middle sheath locking part disclosed in one embodiment of the present invention; Figure 8 This is a schematic diagram of the operation of the middle sheath locking part disclosed in one embodiment of the present invention; Figure 9 This is a cross-sectional view of the proximal body disclosed in one embodiment of the present invention; Figure 10This is a schematic diagram of the housing of the proximal body disclosed in one embodiment of the present invention; Figure 11 This is a schematic diagram of the structure of a locking member disclosed in one embodiment of the present invention.

[0020] Explanation of reference numerals in the attached figures: The components include: a distal cutting section 100, a main body 110, a moving part 120, a groove 121, a clamping arm 130, a hinge point 131, a boss 132, a cutting blade 140, a blade head body 141, a cutting edge 1411, and a control lever 142. Catheter section 200, outer sheath 210, reinforcing layer 211, traction wire 212, middle sheath 220, inner sheath 230. Proximal operating handle 300, distal body 310, rotary operating component 311, threaded moving component 312, traction wire fixing component 313, knob 314, clamping component 315, tapered hole 316, proximal body 320, middle sheath tube adjusting knob 321, middle sheath tube fixing component 322, locking component 323, protrusion 3231, first circumferential section 324, axial section 325, second circumferential section 326, control rod fixing component 327, axial extension tube 328. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions of this invention will be clearly and completely described below in conjunction with specific embodiments and corresponding drawings. In the description of this invention, it should be noted that the term "or" is generally used to include the meaning of "and / or," unless otherwise expressly indicated.

[0022] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. Furthermore, in the description of this application, the terms "first," "second," etc., are used only for distinguishing descriptions and should not be construed as indicating or implying relative importance. The term "proximal end" refers to the end along the length direction of the transcatheter valve leaflet cutting device that is closer to the operator, and the term "distal end" refers to the end along the length direction of the transcatheter valve leaflet cutting device that is farther from the operator.

[0023] Those skilled in the art will understand that, in order to achieve their respective functions and meet the requirements of surgical procedures, the specific shape, size, angle, etc., of each structure can be adaptively adjusted. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without inventive effort are within the scope of protection of the present invention.

[0024] In the existing technology, although the existing transcatheter valve cutting devices can achieve basic valve cutting functions, in practical applications, the structure and operation performance of their proximal operating handle still have significant defects.

[0025] First, the operating handles of existing leaflet cutting instruments generally adopt a segmented design. This structure results in an excessively long and complex overall handle, which not only increases manufacturing costs but also causes inconvenience in clinical operation.

[0026] Secondly, the connection and transmission gaps between the components of the segmented handle inevitably lead to poor control accuracy. Especially when multiple degrees of freedom, such as the movement of the tube and the cutting of the cutting blade, need to be coordinated and controlled simultaneously to achieve precise cutting, the response between the parts is lagging and the action coupling is unclear. This seriously affects the operator's accurate judgment and synchronous control of the spatial position and posture of the remote execution component, making it difficult to provide an integrated, efficient and accurate operating experience.

[0027] refer to Figure 1 , Figure 2 , Figure 5 , Figure 6 To address the problems existing in the prior art, this invention provides a transcatheter valve leaflet cutting device, including a distal cutting section 100, a catheter section 200, and a proximal operating handle 300 connected to the proximal end of the catheter section 200. The catheter section 200, from the inside out, includes an inner sheath 230, a middle sheath 220, and an adjustable outer sheath 210. The proximal operating handle 300 integrates a bending control section, a middle sheath locking section, and a cutting blade locking section. The bending control section controls the bending angle of the distal end of the outer sheath 210. The middle sheath locking section selectively locks the movement of the middle sheath 220 relative to the proximal operating handle 300. The cutting blade locking section selectively locks or unlocks the axial movement of the cutting blade 140 located at the distal end.

[0028] like Figure 2 In some embodiments, the distal cutting section 100 of the transcatheter valve leaflet cutting device is provided with a main body 110, a clamping arm 130, and a cutting blade 140; the proximal end of the main body 110 is connected to the inner sheath 230; the clamping arm 130 is rotatably connected to the main body 110, and the proximal end of the clamping arm 130 is also drivenly connected to the distal end of the middle sheath 220, and the axial movement of the middle sheath 220 is used to control the opening and closing of the clamping arm 130; the proximal end of the cutting blade 140 is connected to a control rod 142, which passes through the inner sheath 230 and is connected to the cutting blade locking part.

[0029] In some embodiments, the main body 110 is configured as a dual-cavity structure, including a hollow inner cavity and a cutter guide groove that are isolated from each other, both extending axially along the main body 110. The hollow inner cavity has a distal opening and a proximal opening for guiding wires. The side of the cutter guide groove is open to accommodate the cutting blade 140 for axial movement. During movement, the cutting blade 140 is exposed to the open area of ​​the cutter guide groove to achieve electrical and / or physical cutting of the leaflets.

[0030] In some embodiments, the clamping arm 130 is connected to the main body 110 by a pivotal connection structure such as rivets, forming a rotatable hinge point 131. A boss 132 is provided on the proximal side of the hinge point 131, and the boss 132 is slidably connected to a moving member 120. The outer peripheral surface of the moving member 120 is provided with an inclined groove 121, which matches the boss 132, and the boss 132 can slide smoothly along the groove 121. Preferably, the moving member 120 is connected to the distal end of the middle sheath tube 220. The axial movement of the middle sheath tube 220 can drive the axial movement of the moving member 120, and finally drive the clamping arm 130 to rotate around the hinge point 131 to achieve opening and closing, so as to achieve clamping of the leaflet tissue.

[0031] like Figure 3 In some embodiments, the cutting blade 140 includes a blade body 141 and a control rod 142, wherein the control rod 142 is fixedly connected to the proximal end of the blade body 141 for controlling the axial movement of the blade body 141; the blade body 141 is provided with a cutting edge 1411 for cutting leaflet tissue, so as to achieve mechanical or electrical cutting of leaflet tissue during movement. Optionally, the cutting edge 1411 is disposed on the side edge at its proximal and / or distal ends; optionally, the cutting edge 1411 is a single-sided cutting edge or a double-sided cutting edge extending obliquely along the axial direction.

[0032] In some embodiments, the control lever 142 is made of a conductive material, and at least the blade 1411 of the cutter body 141 is also made of a conductive material. The control lever 142 is connected to and conducts electricity to the proximal end of the cutter body 141. When no power is applied, only the axial movement of the cutter body 141 can be controlled to achieve physical cutting of the leaflets. When power is applied, the blade 1411 made of conductive material can achieve electrical cutting of the leaflets.

[0033] like Figure 4, in some embodiments, a bendable reinforcing layer 211 and a traction wire 212 are disposed in the tube wall of the outer sheath 210. The reinforcing layer 211 is preferably a metal layer, and may specifically adopt structural forms such as a hypotube, a coil spring or a braided mesh tube. When the traction wire 212 is pulled proximally, the traction wire 212 acts on the distal end of the reinforcing layer 211, causing it to drive the outer sheath 210 to bend. Since the middle sheath 220, the inner sheath 230 and the distal cutting portion 100 are all disposed inside the outer sheath 210, the bending of the aforementioned three components can also be further driven.

[0034] In some embodiments, at least one radiopaque ring is further disposed in the distal tube wall of the outer sheath 210. The radiopaque ring is used for observing the position and bending morphology of the distal end of the outer sheath 210 under surgical angiography, so that the operator can evaluate the relative orientation and distance between the distal cutting portion 100 and the target valve leaflet in real time, thereby performing corresponding adjustment operations and improving the accuracy and safety of the valve leaflet cutting surgery.

[0035] Reference Figures 5-11 , in some embodiments, the proximal operating handle 300 is entirely configured as an integrated structure, and its outer shape is generally in a "┓" shape, including a distal main body 310 extending generally along the axial direction and a proximal main body 320 extending generally along the axial direction. Further, the distal main body 310 is also in a "┓" shape, the distal end of the distal main body 310 is fixedly connected to the proximal end of the outer sheath 210, and the proximal end thereof extends along the axial direction. The proximal main body 320 is rod-shaped, which is inserted through the inside of the proximal end of the distal main body 310 and can slide axially relative to the distal main body 310. The proximal main body 320 is fixedly connected to the proximal ends of the middle sheath 220 and the inner sheath 230, so as to transmit the operations of the middle sheath 220 and the inner sheath 230 to the distal cutting portion 100.

[0036] During the delivery phase of the device, the proximal main body 320 and the distal main body 310 are kept axially relatively locked by the middle sheath locking portion. At this time, the outer sheath 210, the middle sheath 220 and the inner sheath 230 are kept axially fixed relative to each other, and the distal cutting portion 100 is pushed to the target position as a whole along with the delivery system under the guidance of the guide wire. When the distal cutting portion 100 reaches the target working position, the operator operates the middle sheath locking portion to release the axial locking relationship between the proximal main body 320 and the distal main body 310, and then the axial displacement and circumferential rotation of the middle sheath 220 can be realized, or the locking and unlocking of the cutter head can be controlled through the cutter locking portion. With the above integrated handle structure, there is no need to operate separate handle components during the operation, which simplifies the operation process and improves the control accuracy.

[0037] As shown in Figure 5 , Figure 6In some embodiments, the bending control part is disposed on the distal body 310 of the proximal operating handle 300 and extends outward at an angle inclined relative to the central axis of the proximal operating handle 300, preferably between 20° and 45°, to facilitate operator operation and optimize the force distribution on the handle. The bending control part includes a rotating operating component 311, a threaded moving component 312, and a traction wire fixing component 313. The rotating operating component 311 is rotatably disposed on the distal body 310, for example, through a bearing or shaft hole engagement to achieve circumferential rotation positioning; the threaded moving component 312 is threadedly engaged with the rotating operating component 311, and the outer periphery of the threaded moving component 312 has an external thread that matches the internal thread of the rotating operating component 311; the traction wire fixing component 313 is disposed on the proximal side of the threaded moving component 312, with its distal end abutting against the proximal end of the threaded moving component 312. Specifically, the rotation of the rotating operating component 311 can drive the threaded moving component 312 and the traction wire fixing component 313 to move axially, thereby driving the traction wire 212 to achieve bending.

[0038] In some embodiments, the proximal end of the traction wire 212 passes through the threaded moving member 312 and is fixed to the traction wire fixing member 313, for example, by welding, bonding, or mechanical clamping. When the rotating operating member 311 is rotated, the threaded moving member 312 is driven to move axially through the threaded engagement, thereby pushing or allowing the traction wire fixing member 313 to move synchronously, so as to achieve precise pulling or releasing of the traction wire 212.

[0039] In some embodiments, the traction wire fixing member 313 is configured to move proximally only under the push of the threaded moving member 312, and cannot actively pull the threaded moving member 312 distally. Specifically, when the rotating operating member 311 rotates in the first direction, the threaded moving member 312 moves proximally, and its proximally end face abuts against the distal end face of the traction wire fixing member 313, thereby pushing the traction wire fixing member 313 to move proximally synchronously, so as to pull the traction wire 212 to bend the distal end of the outer sheath tube 210; when the rotating operating member 311 rotates in the second direction, the threaded moving member 312 moves distally, at which time the abutting thrust between the traction wire fixing member 313 and the threaded moving member 312 is lost, and the traction wire fixing member 313 passively moves distally under the action of its own elastic restoring force at the distal end of the outer sheath tube 210, so that the distal end of the outer sheath tube 210 gradually returns to its initial straight state.

[0040] The aforementioned unidirectional pushing contact structure avoids problems such as kinking, tangling, or uneven force on the traction wire 212 caused by passive pushing during the bending process, effectively reducing the risk of fatigue fracture of the traction wire 212 or failure of the bending mechanism, and improving the controllability and service life of the bending operation.

[0041] like Figures 6-8In some embodiments, the middle sheath locking part is disposed at the proximal end of the distal body 310 of the proximal operating handle 300, and is located approximately in the middle of the proximal operating handle 300, and is coaxially disposed with the central axis of the proximal operating handle 300; preferably, the middle sheath locking part includes a knob 314 and a clamping member 315; the knob 314 is rotatably disposed on the distal body 310 of the proximal operating handle 300, and the clamping member 315 is fixedly connected to the knob 314; the rotation of the knob 314 can drive the clamping member 315 to contract or expand radially.

[0042] In some embodiments, the middle sheath 220 passes through and is fixedly connected to the proximal body 320 of the proximal operating handle 300. Simultaneously, a tubular structure extending axially is fixedly connected to the distal end of the proximal body 320, defined as an axial extension tube 328, and the middle sheath 220 passes through the lumen of this axial extension tube 328. Therefore, the actual locking object of the middle sheath locking part is the axial extension tube 328, rather than directly acting on the middle sheath 220.

[0043] Specifically, when the knob 314 drives the clamping member 315 to retract radially, the clamping member 315 grips the outer circumferential surface of the axial extension tube 328, thereby locking the relative position between the proximal body 320 and the distal body 310. In this state, the outer sheath 210 fixedly connected to the distal body 310, the middle sheath 220 fixedly connected to the proximal body 320, and the inner sheath 230 are all in a locked state of axial relative fixation. When the knob 314 drives the clamping member 315 to expand radially to release the axial extension tube 328, the locking relationship between the proximal body 320 and the distal body 310 is released. At this time, the operator can drive the middle sheath 220 and the inner sheath 230 to move axially or rotate circumferentially relative to the outer sheath 210 by axially pulling or circumferentially rotating the proximal body 320, thereby driving the distal cutting section 100 to perform corresponding actions such as opening and closing of the clamping arm 130 and moving of the blade through the transmission relationship of the catheter section 200.

[0044] In some embodiments, the clamping member 315 is configured as a tubular structure, with its outer peripheral surface being configured as a tapered surface that gradually tapers axially, and its sidewalls having a plurality of axially extending and circumferentially spaced openings to provide radial deformation capability. Correspondingly, the inner wall of the distal body 310 of the proximal operating handle 300 has a tapered hole 316 that matches the outer peripheral surface of the clamping member 315. After assembly, the clamping member 315 passes through the tapered hole 316, with its outer peripheral surface fitting against the inner peripheral surface of the tapered hole 316; the knob 314 engages with the clamping member 315 in a driving manner to drive the clamping member 315 to move axially within the tapered hole 316.

[0045] When knob 314 is rotated in the first direction, clamping member 315 moves distally within tapered hole 316. Due to the wedge-shaped fit between the tapered surfaces, clamping member 315 is forced to radially contract, its inner circumferential surface clamping against the outer circumferential surface of axial extension tube 328, thereby achieving clamping and locking of axial extension tube 328. When knob 314 is rotated in the second direction, clamping member 315 moves in the opposite direction, the fit clearance of the tapered surfaces increases, and clamping member 315 expands radially under its own elastic restoring force, thereby releasing axial extension tube 328. Through the above-mentioned clamping structure of tapered surface and opening fit, reliable locking and releasing can be achieved with simple rotation operation, the operation is intuitive and the clamping force is stable.

[0046] In some embodiments, the proximal body 320 of the proximal operating handle 300 is further provided with a middle sheath adjustment knob 321 and a middle sheath fixing member 322, both of which are also located approximately in the middle of the proximal operating handle 300; wherein, the middle sheath fixing member 322 is connected to the proximal end of the middle sheath 220; the middle sheath adjustment knob 321 is rotatably disposed on the proximal body 320 of the proximal operating handle 300 and is threadedly engaged with the middle sheath fixing member 322, and the rotation of the middle sheath adjustment knob 321 can drive the axial movement of the middle sheath fixing member 322, so as to drive the middle sheath 220 to move axially relative to the inner sheath 230.

[0047] In some embodiments, after the axial extension tube 328 is released by the middle sheath locking part, the operator can perform coarse adjustment of the middle sheath 220 and inner sheath 230 relative to the outer sheath 210 by axially pulling or circumferentially rotating the proximal body 320 of the proximal operating handle 300, so that the distal cutting part 100 is approximately positioned in the target working position. After the distal cutting part 100 is initially positioned, the operator re-locks the axial extension tube 328 by operating the middle sheath locking part, so that the proximal body 320 and the distal body 310 remain axially fixed.

[0048] Subsequently, the operator rotates the middle sheath adjustment knob 321, driving the middle sheath fixation member 322 to move proximally, thereby causing the middle sheath 220, which is fixedly connected to the middle sheath fixation member 322, to move proximally. The proximal movement of the middle sheath 220 is transmitted through the catheter section 200 to the distal moving member 120, causing the moving member 120 to move proximally relative to the main body 110; due to the sliding engagement between the moving member 120 and the clamping arm 130, the proximal movement of the moving member 120 causes the clamping arm 130 to rotate outward around the hinge point 131, thereby opening the clamping arm 130. After the clamp arm 130 is opened to the appropriate angle, the surgeon rotates the middle sheath adjustment knob 321 in the opposite direction, driving the middle sheath fixation component 322 to move distally, thereby driving the middle sheath 220 to move distally; the moving component 120 moves distally accordingly, and through sliding engagement, drives the clamp arm 130 to rotate inward around the hinge point 131, thereby closing the clamp arm 130 to clamp and fix the target leaflet tissue.

[0049] With the above structure, coarse positioning can be achieved by first sliding the proximal body 320 axially, and then fine control of the opening and closing of the clamping arm 130 can be achieved by rotating the middle sheath adjustment knob 321. This ensures that the distal cutting part 100 can quickly reach the target position, and also achieves precise and controllable adjustment of the leaflet clamping force, thereby improving the safety and accuracy of the surgical operation.

[0050] refer to Figures 9-11 In some embodiments, the cutting blade locking part includes a locking member 323, which is disposed inside the proximal end of the proximal body 320 of the proximal operating handle 300 and can move axially and rotate about the axis relative to the proximal body 320. The proximal end of the control rod 142 of the cutting blade 140 passes through the control rod fixing member 327, which is accommodated in the inner cavity of the locking member 323. The control rod fixing member 327 and the locking member 323 can rotate freely relative to each other in the circumferential direction (e.g., through clearance fit or bearing structure), while in the axial direction they are linked by a limiting structure such as an annular step or retaining ring provided in the inner cavity. This allows the axial movement of the locking member 323 to drive the control rod fixing member 327 and the control rod 142 to move synchronously, while the rotation of the locking member 323 will not be transmitted to the control rod 142 and the blade body 141, thereby avoiding unnecessary twisting of the blade in the blade guide groove and ensuring that the blade 1411 is always in the correct cutting orientation.

[0051] In some embodiments, the locking member 323 is connected to the proximal end of the control lever 142, and the outer periphery of the locking member 323 is provided with at least one protrusion 3231; the proximal body 320 of the proximal operating handle 300 is provided with a guide groove that cooperates with the protrusion 3231, the guide groove includes a first circumferential section 324, an axial section 325 and a second circumferential section 326 that are sequentially connected from the proximal end to the distal end; the protrusion 3231 can enter the guide groove from the first circumferential section 324, move to the distal end along the axial section 325 to the second circumferential section 326, and after circumferentially rotating within the second circumferential section 326, the locking member 323 is axially locked relative to the proximal operating handle 300.

[0052] In some embodiments, the first circumferential segment 324 and the second circumferential segment 326 are both arc-shaped grooves extending in the circumferential direction, and their corresponding central angles are preferably 60°; the protrusion 3231 can smoothly transition between the first circumferential segment 324 and the axial segment 325, and between the axial segment 325 and the second circumferential segment 326.

[0053] When the protrusion 3231 is located in the second circumferential section 326, the locking member 323 is restricted to this circumferential position. At this time, the cutter body 141 is positioned at the farthest end of the cutter guide groove for delivery and initial positioning via the duct leaflet cutting device. When the operator rotates the locking member 323 to move the protrusion 3231 from the second circumferential section 326 into the axial section 325 and moves it proximally along the axial section 325, the control rod fixing member 327 and the control rod 142 are driven to move proximally. The cutter body 141 then moves from the farthest end to the nearest end within the cutter guide groove, thereby achieving the cutting of the leaflet tissue. After the protrusion 3231 moves to the proximal end of the axial section 325, the operator rotates the locking member 323 again to move the protrusion 3231 into the first circumferential section 324. At this time, the cutter body 141 is positioned at the nearest end of the cutter guide groove.

[0054] Preferably, the length of the axial section 325 of the guide groove is configured to be equal to the movable distance of the cutter body 141 within the cutter guide groove. This ensures that when the protrusion 3231 moves from the second circumferential section 326 to the first circumferential section 324, the cutter body 141 can complete the entire stroke from the farthest end to the nearest end, achieving complete cutting of the leaflet tissue. Through the above-described guide groove design, the cutter head is allowed to move only in the axial section 325, while its locking position is achieved in the two circumferential sections. This ensures both safety during transport and precise control of the cutting stroke.

[0055] In some embodiments, the locking member 323 has two symmetrically arranged protrusions 3231 along its outer periphery. Correspondingly, the proximal body 320 of the proximal operating handle 300 has two symmetrically arranged guide grooves along its inner periphery that mate with the protrusions 3231. By adopting a symmetrical double protrusion 3231 and double guide groove mate structure, the locking member 323 can be subjected to more balanced forces during axial movement and circumferential rotation, avoiding skewness or jamming caused by unilateral force, thereby improving the smoothness of operation and the reliability of positioning of the locking member 323.

[0056] Compared with the prior art, the transcatheter valve leaflet cutting device provided in this embodiment of the invention has at least the following advantages: First, by integrating the near-end operating handle 300 into a single structure and incorporating the bending control section, the middle sheath locking section, and the cutting blade locking section, the problems of complex structure and excessive overall length of existing segmented handles are solved. This integrated handle not only simplifies the operation process but also enables the operator to achieve precise multi-degree-of-freedom control of the outer sheath 210 bending, the axial movement of the middle sheath 220 (clamp arm 130 opening and closing), and the movement of the cutting blade 140 using a single handle. This significantly improves the control accuracy and responsiveness, avoiding the problem of poor control accuracy caused by connection gaps in segmented designs.

[0057] Secondly, by tilting the bending control part at the distal end of the handle body 310 and cooperating with the threaded transmission structure, the bending angle of the outer sheath 210 can be precisely adjusted, optimizing the force distribution during the operator's operation. Furthermore, the locking part of the middle sheath adopts a structure that combines a conical surface with an open clamping member 315, which can reliably lock and release the axial extension tube 328 with a simple rotation operation. The operation is intuitive and the clamping force is stable, ensuring the reliability of the delivery and working state switching.

[0058] Furthermore, the cutting blade locking part, through the cooperation of the guide groove and the protrusion 3231, combined with the circumferential free rotation structure between the control rod fixing part 327 and the locking part 323, not only achieves reliable locking of the cutting head in the conveying and working state, but also ensures that the cutting head can complete the complete cutting of the leaf tissue along the predetermined stroke by limiting the movement path of the cutting head in the axial section 325. At the same time, it effectively avoids the unexpected twisting of the cutting head during the cutting process, further improving the safety and accuracy of cutting.

[0059] As can be seen from the above, the transcatheter leaflet cutting device provided by the embodiments of the present invention, while achieving a compact structure and ease of manufacturing, effectively improves the precision and convenience of multi-degree-of-freedom control, improves compatibility with standard delivery guidewires, and significantly improves the safety and operational efficiency of leaflet cutting surgery.

[0060] Furthermore, this embodiment of the invention also provides a transcatheter valve leaflet cutting system, including the transcatheter valve leaflet cutting device described in the above embodiments. The various technical features already included in the above embodiments are naturally inherited in this embodiment and will not be repeated.

[0061] In some embodiments, in addition to the transcatheter valve cutting device, the system further includes medical auxiliary devices or instruments such as a guide wire, catheter, image guidance device, and external power supply to assist in completing the surgical procedure. Specifically, the operation of the transcatheter valve cutting device in this embodiment is the same as in the above embodiments, and will not be repeated here.

[0062] Although exemplary embodiments have been described herein with reference to the accompanying drawings, it should be understood that the above exemplary embodiments are merely illustrative and are not intended to limit the scope of this application. Various changes and modifications can be made therein by those skilled in the art without departing from the scope and spirit of this application. All such changes and modifications are intended to be included within the scope of this application as claimed in the appended claims.

Claims

1. A transcatheter valve leaflet cutting device, characterized in that, It includes a distal cutting section, a catheter section, and a proximal operating handle connected to the proximal end of the catheter section; The distal cutting section is used to clamp and cut the leaflet tissue; the catheter section includes, from the inside out, an inner sheath, a middle sheath, and an adjustable outer sheath. The proximal operating handle integrates: The bending control section is used to control the bending angle of the distal end of the outer sheath. A locking part for selectively locking the movement of the middle sheath relative to the proximal operating handle; A cutting blade locking part is used to selectively lock or unlock the axial movement of the cutting blade located at the distal cutting part.

2. The transcatheter valve leaflet cutting device according to claim 1, characterized in that, The distal cutting section is also provided with a main body and a clamping arm; The proximal end of the main body is connected to the inner sheath. The clamping arm is rotatably connected to the main body, and the proximal end of the clamping arm is also drively connected to the distal end of the middle sheath. The axial movement of the middle sheath is used to control the opening and closing of the clamping arm. A control rod is connected to the proximal end of the cutting blade. The control rod passes through the inner sheath and is connected to the locking part of the cutting blade.

3. The transcatheter valve leaflet cutting device according to claim 2, characterized in that, The outer sheath has a traction wire inside its wall. The distal end of the traction wire is fixed inside the wall of the outer sheath, and the proximal end of the traction wire extends to the bending control section. The bending control section is used to control the axial movement of the traction wire to adjust the bending angle of the distal end of the outer sheath.

4. The transcatheter valve leaflet cutting device according to claim 3, characterized in that, The bending control portion is located on the distal body of the proximal operating handle and extends outward at an angle relative to the central axis of the proximal operating handle.

5. The transcatheter valve leaflet cutting device according to claim 4, characterized in that, The bending control part includes a rotating operating component, a threaded moving component, and a traction wire fixing component; The threaded moving part is threadedly engaged with the rotating operating part. The rotating operating part is rotatably mounted on the distal body of the proximal operating handle. The rotation of the rotating operating part can drive the threaded moving part and the traction wire fixing part to move axially, so as to pull the traction wire to achieve bending.

6. The transcatheter valve leaflet cutting device according to claim 5, characterized in that, The traction wire passes through the threaded moving member and connects to the traction wire fixing member, the distal end of the traction wire fixing member abutting against the proximal end of the threaded moving member; the traction wire fixing member is configured as follows: When the threaded moving member moves toward the proximal end, it pushes the traction wire fixing member to move toward the proximal end simultaneously, so as to pull the traction wire and bend the distal end of the outer sheath tube. When the threaded moving member moves to the distal end, the traction wire fixing member is passively moved to the distal end under the elastic restoring force of the outer sheath.

7. The transcatheter valve leaflet cutting device according to claim 2, characterized in that, The locking part of the middle sheath tube is coaxially arranged with the central axis of the proximal operating handle; The locking part of the middle sheath includes a knob and a clamping member; the knob is rotatably disposed on the distal body of the proximal operating handle, and the clamping member is in transmission cooperation with the knob; the rotation of the knob can drive the clamping member to retract radially to limit the middle sheath in the axial and circumferential directions, or to expand radially to release the middle sheath.

8. The transcatheter leaflet cutting device according to claim 7, characterized in that, The clamping member is a tubular structure with its outer circumferential surface configured as a tapered surface that gradually tapers along the axial direction, and its sidewalls are provided with multiple openings that extend along the axial direction and are arranged at intervals in the circumferential direction. The distal body of the proximal operating handle is provided with a tapered hole that matches the outer peripheral surface of the clamping member; The rotation of the knob can drive the clamping member to move axially within the tapered hole, and the engagement of the tapered surface forces the clamping member to contract radially.

9. The transcatheter valve leaflet cutting device according to claim 2, characterized in that, The cutting blade locking part is located at the proximal end of the proximal operating handle and is coaxial with the central axis of the proximal operating handle; The cutting blade locking part includes a locking member, which is connected to the proximal end of the control lever, and the outer periphery of the locking member is provided with at least one protrusion. The proximal body of the proximal operating handle is provided with a guide groove that mates with the protrusion. The guide groove includes a first circumferential section, an axial section, and a second circumferential section that are connected sequentially from the proximal end to the distal end. The protrusion can enter the guide groove from the first circumferential section, move distally along the axial section to the second circumferential section, and after circumferential rotation within the second circumferential section, achieve axial locking of the locking member relative to the proximal operating handle.

10. The transcatheter valve leaflet cutting device according to claim 9, characterized in that, The locking member has two protrusions symmetrically arranged along its outer periphery, and the proximal body of the proximal operating handle has two guide grooves symmetrically arranged along its inner periphery.

11. The transcatheter valve leaflet cutting device according to claim 2, characterized in that, The proximal operating handle is also provided with a middle sheath tube adjustment knob and a middle sheath tube fixing component in the middle part; The middle sheath fixing member is connected to the proximal end of the middle sheath; the middle sheath adjusting knob is rotatably disposed on the proximal body of the proximal operating handle and is threadedly engaged with the middle sheath fixing member. The rotation of the middle sheath adjusting knob can drive the axial movement of the middle sheath fixing member, thereby causing the middle sheath to move axially relative to the inner sheath.

12. A transcatheter valve leaflet cutting system, characterized in that, Includes the transcatheter leaflet cutting device as described in any one of claims 1-11.

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