Delivery system for medical device

Abstract

The present application provides a valve clamping system, comprising a first clamp piece, a second clamp piece, a catheter, a first actuation element, a second actuation element, and a handle. The first actuation element engages with the first clamp piece and extends proximally through the catheter. The second actuation element engages with the second clamp piece and extends proximally through the catheter. The handle comprises a handle housing connected to a proximal end of the catheter, a first actuation controller and a second actuation controller respectively connected to the first actuation element and the second actuation element, a first linkage member and a second linkage member respectively coupled to the first actuation controller and the second actuation controller, and an unlocking member. The two linkage members cooperate with the unlocking member to achieve both synchronized control and independent control of the first actuation controller and the second actuation controller. The valve clamping system enables synchronous clamping of two valve leaflets of a cardiac valve, ensuring clamping symmetry and consistency in clamping depth, and guaranteeing surgical efficacy.

Description

Medical device delivery systems

[0001] This application claims priority to the Chinese patent application filed with the Patent Office of China on January 30, 2024, with application number 202410126168.0 and application name “Valve clamping system with linkage control”, and also claims priority to the Chinese patent application filed with the Patent Office of China on July 22, 2024, with application number 202410985676.4 and application name “Delivery system for medical device”, all contents of which are incorporated by reference into this application. Technical Field

[0002] The present invention relates to the technical field of medical devices, and in particular to a delivery system for medical devices. Background Art

[0003] Heart disease is a major global health threat, with valvular heart disease being the most common. For valvular heart disease caused by various pathologies, interventional procedures are less invasive, minimally invasive, and safer than open-heart surgery. Consequently, the technology for treating lesions through interventional procedures has developed rapidly in recent years. Current mainstream interventional procedures include artificial chordal implantation, edge-to-edge repair, and annuloplasty. Generally, these procedures involve minimally invasive catheter-based interventions, performed remotely from outside the patient's body under the guidance of medical imaging. Because interventional procedures are performed without direct vision, utilizing a delivery system to deliver the interventional device to the target treatment site within the patient's body and accurately positioning the device for successful execution still present various challenges, such as a low success rate and, in severe cases, even life-threatening consequences. Summary of the Invention

[0004] In order to address the deficiencies in the prior art, the present application provides a valve clipping system, comprising:

[0005] A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm;

[0006] catheter;

[0007] a first actuating element and a second actuating element, the first actuating element being removably coupled to the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; and a second actuating element being removably coupled to the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; and

[0008] A handle, comprising:

[0009] a handle housing connected to the proximal end of the catheter;

[0010] a first actuation controller and a second actuation controller, wherein the first actuation controller is connected to a proximal end of the first actuation element, and the second actuation controller is connected to a proximal end of the second actuation element;

[0011] a first linkage member and a second linkage member, the first linkage member coupled to the first actuation controller, the second linkage member coupled to the second actuation controller; and

[0012] An unlocking member is connected to the first linkage member, and the unlocking member can be displaced relative to the second linkage member under the action of an external force to switch between connecting the first actuation controller and the second actuation controller and releasing the connection, thereby controlling the first actuation element and the second actuation element to move synchronously or individually.

[0013] In a second aspect, the present application provides a valve clipping system, comprising:

[0014] A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm;

[0015] catheter;

[0016] a first actuating element and a second actuating element, the first actuating element being removably coupled to the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; and a second actuating element being removably coupled to the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; and

[0017] A handle, comprising:

[0018] a handle housing connected to the proximal end of the catheter;

[0019] a first actuation controller and a second actuation controller, the first actuation controller being connected to a proximal end of the first actuation element, and the second actuation controller being connected to a proximal end of the second actuation element; and

[0020] A first linkage member and a second linkage member, the first linkage member is coupled to the first actuation controller, and the second linkage member is coupled to the second actuation controller; the first linkage member and the second linkage member can rotate synchronously relative to the handle housing to linkage control the first actuation controller and the second actuation controller to move synchronously toward the proximal end or the distal end, thereby driving the first actuation element and the second actuation element to move synchronously toward the proximal end or the distal end.

[0021] In a third aspect, the present application provides a valve clamping system with linkage control, comprising:

[0022] A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm;

[0023] catheter;

[0024] a first actuating element and a second actuating element, wherein the first actuating element is removably coupled to the first clip, the first actuating element proximally extending through the catheter and being axially movable relative to the catheter; and a second actuating element is removably coupled to the second clip, the second actuating element proximally extending through the catheter and being axially movable relative to the catheter; and

[0025] A handle, comprising:

[0026] a handle housing connected to the proximal end of the catheter and having a central axis axially aligned with the catheter;

[0027] a first actuation controller and a second actuation controller, the first actuation controller being connected to a proximal end of the first actuation element, and the second actuation controller being connected to a proximal end of the second actuation element; and

[0028] a linkage member connecting the first actuation controller and the second actuation controller;

[0029] The first actuation controller has a first axis intersecting with the central axis, and the second actuation controller has a second axis intersecting with the central axis; the linkage component can linkage control the first actuation controller to move along the first axis relative to the handle housing, and the second actuation controller to move along the second axis relative to the handle housing.

[0030] In a fourth aspect, the present application provides a delivery system for a medical device, comprising:

[0031] A first delivery device comprising a first handle and a first catheter extending distally from the first handle, the first catheter comprising a bendable distal section; and

[0032] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device, the second catheter having a first section and a second section with a reduced outer diameter along its axial length, the second section being located distal to the first section;

[0033] The first handle is manipulated to force the distal section of the first catheter to bend, and the second section of the second catheter can be shaped into a curved shape by the curved distal section and can at least partially recover to its original shape from the curved shape after extending from the curved distal section.

[0034] In a fifth aspect, the present application provides a transcatheter delivery system for a medical device, comprising:

[0035] A first delivery device comprising a first handle and a first catheter extending distally from the first handle, the first catheter comprising a bendable and / or pre-shaped distal section; and

[0036] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device; and

[0037] A third delivery device, comprising a third handle and a third catheter extending distally from the third handle, the third catheter comprising a bendable section at a distal end, the first catheter coaxially extending through the third delivery device;

[0038] The second catheter includes a proximal section extending along its axial length, and the proximal section includes a laser-cut tube; the second delivery device is capable of delivering the medical device through blood vessels to a target area of ​​the heart in the body under the bending cooperation of the distal section and the bendable section, and the proximal section is always positioned outside the body.

[0039] In a sixth aspect, the present application provides a delivery system for a medical device, comprising:

[0040] A first delivery device includes a first handle and a first catheter extending distally from the first handle, wherein a distal coupler is fixedly provided at the distal end of the first catheter; and

[0041] a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device; a protective coupler fixedly provided at the distal end of the second catheter, the medical device being removably coupled to the protective coupler;

[0042] The distal coupler has an axially through-going coupling cavity, and the outer surface of the protective coupler is formed with a circumferential coupling surface, which can be circumferentially coupled in the coupling cavity to shorten the axial distance of the medical device relative to the distal coupler.

[0043] This application improves the success rate of surgery by rationally and effectively designing the valve clamping system and the delivery system to successfully deliver the medical device to the target area in the patient's body. BRIEF DESCRIPTION OF THE DRAWINGS

[0044] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the application and, together with the description, serve to explain the principles of the invention.

[0045] To more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some implementation methods provided by the embodiments of the present application. For those skilled in the art, other drawings can be derived from these drawings without inventive effort.

[0046] FIG1 shows a delivery system for a medical device in a first embodiment, and is a schematic diagram showing a state in which a second section of a second catheter is formed into a curved configuration.

[0047] FIG. 2 is a schematic diagram showing a state where the second section in FIG. 1 returns to its initial state.

[0048] FIG3 shows a cross-sectional view of a coil extending axially through a second conduit.

[0049] FIG4 is a schematic diagram showing a state in which the second catheter extends from the distal end of the first catheter and moves a distance.

[0050] FIG5 is a schematic structural diagram showing a second conduit coaxially extending through the first conduit.

[0051] FIG6 shows a schematic structural diagram of the lubricating coating on the second conduit.

[0052] FIG. 7 shows a schematic structural diagram of the conveying system in FIG. 1 further including a third conveying device.

[0053] FIG8 shows another schematic structural diagram of the lubricating coating on the second conduit.

[0054] FIG9 is a schematic diagram showing a scenario of the bending angle range of the distal section of the first catheter.

[0055] FIG10 shows a schematic structural diagram of the pulling member of the first catheter.

[0056] FIG11 is a schematic diagram showing a scene after the first conduit extends out of the third conduit.

[0057] FIG12 is a schematic diagram showing a scene of the bending angle range of the first catheter under the action of the traction member and the bending curve.

[0058] FIG13 is a schematic structural diagram of a transcatheter delivery system for a medical device in a second embodiment.

[0059] FIG. 14 shows a schematic structural diagram of the second conduit in FIG. 13 .

[0060] FIG. 15 shows a schematic structural diagram of the laser-cut tube in FIG. 14 .

[0061] FIG16 shows the layered structures of the second catheter at the proximal section, the middle section, and the distal section, respectively.

[0062] FIG17 is a schematic diagram showing a scenario of a delivery system for a medical device in the third embodiment.

[0063] FIG. 18 shows a schematic structural diagram of the cooperation between the remote coupler and the protective coupler in FIG. 17 .

[0064] 19-20 respectively show side cross-sectional views of the first conveying device and the second conveying device in FIG. 18 .

[0065] FIG21 is a schematic diagram showing a valve clamping system in a linkage control state and a valve clamping device in a state where the first clip and the second clip are closed relative to the clamp arm in the fourth embodiment.

[0066] FIG. 22 is a schematic diagram showing the first clamp and the second clamp in FIG. 21 being unfolded relative to the clamp arm under linkage control.

[0067] FIG. 23 shows a schematic structural diagram of the valve clamping system in FIG. 22 after the upper shell is closed.

[0068] FIG. 24 shows a schematic structural diagram of the handle in FIG. 22 .

[0069] FIG. 25 shows a schematic diagram of the sealing design of the handle in FIG. 24 .

[0070] FIG. 26 shows a schematic structural diagram of the first control handle in FIG. 25 .

[0071] FIG27 is a perspective schematic diagram showing a first method of releasing linkage control.

[0072] FIG28 shows a schematic structural diagram of a second method for releasing linkage control.

[0073] FIG. 29 shows a schematic structural diagram of FIG. 28 after the upper shell is removed.

[0074] FIG. 30 is a perspective sectional view showing the unlocking member in FIG. 28 being pulled up to release the linkage control.

[0075] FIG31 is a schematic structural diagram of the unlocking component in FIG30 .

[0076] FIG32 shows a schematic structural diagram of the knob in FIG31 .

[0077] FIG33 shows a schematic structural diagram of the upper shell in FIG30 .

[0078] FIG34 shows a schematic structural diagram of the connecting rod in FIG31 .

[0079] FIG. 35 shows a perspective sectional view of the unlocking member connected to the upper housing in FIG. 30 .

[0080] FIG. 36 shows a side cross-sectional view of FIG. 35 .

[0081] FIG37 shows another schematic structural diagram of the first control handle.

[0082] FIG38 is a schematic diagram showing the valve clamping system in the fifth embodiment in a linkage control state, with the valve clamper in a state where the first clip and the second clip are closed relative to the clamp arm.

[0083] FIG39 is a schematic diagram showing the first clamp and the second clamp in FIG38 being unfolded relative to the clamp arm under linkage control.

[0084] FIG40 shows a schematic structural diagram of the handle in the fifth embodiment.

[0085] FIG41 shows a schematic structural diagram of the first actuation controller and the second actuation controller in FIG40 .

[0086] FIG42 shows another schematic structural diagram of the first actuation controller and the second actuation controller in FIG40 . DETAILED DESCRIPTION

[0087] In order to make the technical problems, technical solutions, and technical effects addressed by the embodiments of this application clearer, the technical solutions of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are only part of the embodiments of this application, not all of them. Based on the embodiments in this application, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of this application.

[0088] In the description of the present invention, it should be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the axial direction refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; the radial direction refers to the direction perpendicular to or approximately perpendicular to the axial direction; and the circumferential direction refers to the direction surrounding the axial direction. It is worth noting that the "end" appearing in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes the part extending from the end, endpoint, or end face to a certain axial distance and / or radial distance on the component to which the end, endpoint, or end face belongs. The above definitions are only for the convenience of expression and should not be understood as limitations of the present invention.

[0089] In a first embodiment, the present invention provides a delivery system 100a for a medical device for delivering a medical device 300 into a patient's body to treat heart disease. For example, the delivery system 100a can enter the patient's body through a transapical route or a transcatheter route. Specifically, referring to Figures 1 and 2, the delivery system 100a includes a first delivery device 20 and a second delivery device 30. The first delivery device 20 includes a first handle 21 and a first catheter 22 extending distally from the first handle 21, and the first catheter 22 includes a bendable distal section 221. The second delivery device 30 includes a second handle 31 and a second catheter 32 extending distally from the second handle 31, and the second catheter 32 coaxially extends through the first delivery device 20.

[0090] The second catheter 32 has a first section 321 and a second section 322 with a reduced outer diameter along its axial length. The second section 322 is located distal to the first section 321. As shown in FIG1 , by manipulating the first handle 21 to force the distal section 221 of the first catheter 22 to bend, the second section 322 of the second catheter 32 can be shaped into a curved configuration by the curved distal section 221. After extending from the curved distal section 221, the second section 322 of the second catheter 32 can at least partially return from the curved configuration shown in FIG1 to the initial configuration shown in FIG2 . In some embodiments, the initial configuration is an unbent configuration.

[0091] For some applications, the second section 322 of the second catheter 32 is molded into a curved shape, including: first manipulating the first handle 21 to force the distal section 221 of the first catheter 22 to bend, and then driving the second catheter 32 to translate axially to control its second section 322 to pass through the curved distal section 221 and be molded into a curved shape; and, the second section 322 of the second catheter 32 is pre-accommodated in the distal section 221 of the first catheter 22, and when the first handle 21 is manipulated to force the distal section 221 to bend, the second section 322 will be molded into a curved shape by the curved distal section 221.

[0092] Given that the outer diameter of the second section 322 of the second catheter 32 is smaller than that of the first section 321, the second section 322 must have a stronger recovery performance than the first section 321. Therefore, after extending from the curved distal section 221, the second section 322 must be able to quickly return from its curved configuration to its initial configuration. This ensures that during cardiac surgery, after extending from the first catheter 22, the second catheter 32 remains substantially coaxial with the first catheter 22, particularly at their distal ends, such as maintaining X-axis coaxiality. This ultimately ensures the accuracy of subsequent manipulation of the second catheter 32 relative to the first catheter 22, significantly improving surgical precision.

[0093] The delivery system 100a of the present invention ensures the recovery performance of the second catheter 32, avoiding the defects in the prior art where the second catheter 32 is easily prone to unexpected movement or bending deformation after extending from the first catheter 22, which ultimately causes the second catheter 32 to lose its coaxiality with the first catheter 22, for example, causing the X' axis of the distal second catheter 32 to deviate from the X axis of the distal first catheter 22 (see Figure 2). At the same time, the delivery system 100a of the present invention further ensures the precision of control during surgery, significantly shortening the operation time and avoiding the defects in the prior art where the second catheter 32 is easily prone to unexpected deformation after extending from the first catheter 22, which in turn requires the reorientation of the first catheter 22, resulting in excessive surgical operations, which can easily lead to various other unexpected accidents and prolonged surgery time.

[0094] Furthermore, under manipulation of the second handle 31, the second catheter 32 can move within the first catheter 22, such as by twisting and / or axial translation. During the twisting and / or axial translation process, particularly when the second catheter 32 moves within the already curved distal section 221, excessive friction is more likely to be generated between the second catheter 32 and the distal section 221, thereby causing unsmooth twisting and / or axial translation. In the delivery system 100a of the present invention, the outer diameter of the second section 322 of the second catheter 32 is smaller than that of the first section 321. This significantly reduces the friction between the second section 322 of the second catheter 32 and the first section 321 when the second section 322 of the second catheter 32 passes through the curved distal section 221, thereby ensuring that the second section 322 of the second catheter 32 can smoothly extend from the distal section 221 of the second catheter 32, further enhancing the delivery efficiency of the delivery system 100a.

[0095] Of course, to enhance the recovery performance of second conduit 32 in delivery system 100a, in a further embodiment, as shown in FIG3 , second delivery device 30 further includes an axially incompressible coil 33, which coaxially extends through second conduit 32. Coil 33 can enhance the recovery performance of second conduit 32, specifically, it enhances the ability of second section 322 to recover from its bent configuration to its original configuration. Preferably, coil 33 is a flat wire spring tube.

[0096] For some applications, the coil 33 coaxially extends through the entire lumen of the second catheter 32; that is, the axial length of the coil 33 is equal to the axial length of the second catheter 32. For other applications, to ensure that the release rod 34 shown in FIG5 can smoothly pass through and move within the second catheter 32, the coil 33 is formed with an axially extending through-lumen 330 for the release rod 34 to pass through.

[0097] In some embodiments, as shown in FIG4 , the second catheter 32 can extend from the distal end of the distal section 221 of the first catheter 22 and move a travel distance S. The axial length L2 (see FIG5 ) of the second section 322 of the second catheter 32 is equal to the travel distance S. After moving the travel distance S, the second section 322 of the second catheter 32 is fully extended from the curved distal section 221, and the distal-most end of the first section 321 is positioned at the distal-most end of the distal section 221. Because the gap between the first section 321 and the first catheter 22 is smaller than the gap between the second section 322 and the first catheter 22, positioning the distal-most end of the first section 321 at the distal-most end of the distal section 221 facilitates coaxial positioning of the first and second catheters 22, such as maintaining X-axis coaxial positioning. This design enhances the coaxial positioning of the first and second catheters 22, eliminating the need to reorient the first catheter 22, thereby providing precise positioning for subsequent twisting and other manipulations of the second catheter 32. Preferably, the stroke distance S ranges from 40 mm to 80 mm.

[0098] In some applications, a distal coupler 23 is fixedly mounted at the distal end of the distal section 221 of the first catheter 22. The second catheter 32 can sequentially pass through the first catheter 22 and the distal coupler 23, and then move a distance S. After moving the distance S, the distal end of the first section 321 is positioned against the distal coupler 23. The distal coupler 23 is made of metal, such as stainless steel. Due to its smoothness and low friction, a metal distal coupler 23 facilitates smooth advancement of the first catheter 22 within a blood vessel or other device.

[0099] For other applications, a protective coupler 35 is fixedly mounted at the distal end of the second section 322 of the second conduit 32. Specifically, the distal coupler 23 has an axially extending engagement cavity 230. A circumferential engagement surface 350 is formed on the outer surface of the protective coupler 35. The circumferential engagement surface 350 is capable of circumferentially engaging within the engagement cavity 230. For the detailed structure, mating relationship, and corresponding technical effects of the distal coupler 23 and protective coupler 35, please refer to the subsequent discussion of Figures 17-20 and will not be further elaborated here.

[0100] In some embodiments, as shown in FIG5 , the difference in outer diameter between the first section 321 and the second section 322 of the second catheter 32 ranges from 0.3 mm to 1.05 mm. Specifically, assuming the axial length of the first section 321 is L1, the outer diameter of the first section 321 is D1, the axial length of the second section 322 is L2, the outer diameter of the second section 322 is D2, the inner diameter of the first catheter 22 is D3, and the axial length of the distal section 221 of the first catheter 22 is L3. To ensure that the second catheter 32 can extend through the first catheter 22 and move smoothly within the first catheter 22, thereby reducing interference between the two during delivery, D3>D1>D2 is necessarily required. Furthermore, to ensure that the axial length L2 of the second section 322, with its reduced outer diameter, completely covers the flexible distal section 221, thereby reducing friction generated by the second catheter 32 moving within the curved distal section 221, preferably, L1>L2>L3 is required. For some applications, the outer diameter D1 of the first section 321 is in the range of 3.65 mm to 3.95 mm, the outer diameter D2 of the second section 322 is in the range of 2.9 mm to 3.65 mm, and the inner diameter D3 of the first conduit 22 is in the range of 4.1 mm to 4.8 mm.

[0101] Furthermore, in order to avoid the risk of breakage due to a sharp change in outer diameter at the junction of the first section 321 and the second section 322 of the second conduit 32, a smooth taper with a taper distance in the range of 10mm-25mm is provided between the first section 321 and the second section 322 to achieve a smooth transition between the two.

[0102] It should be noted that in some embodiments, referring to FIG. 5 , the medical device 300 includes a valve clip, and the second delivery device 30 utilizes a release rod 34 movable within the second catheter 32 to removably couple the valve clip to the distal end of the second catheter 32 or to the protective coupler 35 via the release rod 34. To ensure smooth movement of the release rod 34 within the second catheter 32, the inner diameter of the first section 321 is equal to the inner diameter of the second section 322.

[0103] Of course, to further reduce friction between the first conduit 22 and the second conduit 32, as shown in Figures 6-8, the second conduit 32 further includes a lubricating coating 320. The lubricating coating 320 can be made of a biocompatible polyvinyl pyrrolidone (PVP) material and attached to the outer surface of the second conduit 32 through a light-curing process. Alternatively, the lubricating coating 320 can be made of a PTFE inner-etched tube with a low friction coefficient and attached to the outer surface of the second conduit 32 through a heat-melt welding process.

[0104] For some applications, as shown in FIG. 6 , the lubricating coating 320 is disposed on the outer surface of the second section 322 of the second conduit 32 , and the length L of the lubricating coating 320 is equal to the axial length L2 of the second section 322 .

[0105] For other applications, as shown in Figures 7-8, the delivery system 100a further includes a third delivery device 40, comprising a third handle 41 and a third catheter 42 extending distally from the third handle 41. The first catheter 22 coaxially extends through the third delivery device 40 and is movable, such as by twisting and / or axial translation, within the third delivery device 40. The third catheter 42 includes a distal bendable segment 421. Preferably, the bendable segment 421 bends at an angle ranging from 0 to 120 degrees. Furthermore, the outer surfaces of the second segment 322 and at least a portion of the first segment 321 of the second catheter 32 are provided with a continuous lubricating coating 320. The length L of the lubricating coating 320 is greater than or equal to the sum of the axial length L2 of the second segment 322, the axial length L3 of the distal segment 221 of the first catheter 22, and the axial length L4 of the bendable segment 421 of the third catheter 42. That is, the length L of the lubricating coating 320 is ≥ L2 + L3 + L4, and the preferred range of L is between 120 mm and 180 mm. Preferably, the length L of the lubricating coating 320 is equal to the axial length of the second conduit 32, that is, L = L1 + L2, and the entire outer surface of the second conduit 32 is coated with the lubricating coating 320.

[0106] Furthermore, to ensure that the distal section 221 of the first catheter 22 can move within a predetermined bending angle range, allowing the first catheter 22 to be positioned along a predetermined route at a target region within the heart, such as approximately the center of the valve annulus, in some embodiments, as shown in FIG9 , the first catheter 22 further includes a proximal section 222 and a traction lumen 220 extending at least partially through the proximal section 222 and the distal section 221. The distal end of at least one traction member 223 is attached to the distal section 221, and the proximal end of the traction member 223 extends through the traction lumen 220 and is attached to the first handle 21. Manipulating the first handle 21 to actuate the traction member 223 pulls the distal section 221, allowing the distal section 221 to move within a bending angle range of 0 to 90 degrees, thereby shaping the second section 322 of the second catheter 32 into a curved configuration having substantially the same curvature as the distal section 221.

[0107] Specifically, as shown in FIG10 , the traction member 223 includes a traction wire 223a and a distal pull ring 223b. The distal pull ring 223b is fixed to the distal segment 221, for example, by heat-seal. The distal end of the traction wire 223a is connected to the distal pull ring 223b, while the proximal end extends through the traction lumen 220 and is attached to the first handle 21. Under manipulation of the first handle 21, the traction wire 223a can be pulled and tightened, forcing the distal segment 221 of the first catheter 22 to bend or deform. The bent distal segment 221 is then deformed into a second segment 322 that can extend from the distal segment 221 of the first catheter 22. Due to the recovery properties of the second segment 322, the second segment 322 can quickly return from the bent state to at least partially its original shape.

[0108] In the application scenario shown in FIG11 , the third catheter 42 passes through the atrial septum 51 of the heart and is positioned within the atrium. Next, the first catheter 22 is manipulated to extend from the distal end of the third catheter 42 and then bend. However, during the process of manipulating the first catheter 22 to extend from the distal end of the third catheter 42, the first catheter 22 or the medical device 300 extending from the distal end of the first catheter 22 can easily accidentally contact the inner side of the atrial wall 52 opposite the atrial septum 51, thereby causing damage to atrial tissue.

[0109] To ensure that the delivery system 100a can completely prevent the first catheter 22 from contacting cardiac tissue when extending from the distal end of the third catheter 42 in the application scenario shown in FIG11 , for example, by avoiding the inner side of the atrial wall 52, the distal section 221 of the first catheter 22 is pre-shaped with a curved curve, as shown in both FIG11 and FIG12 . Preferably, the angle of the curved curve ranges from 20 to 30 degrees, and the axial length L5 ranges from 20 mm to 25 mm. That is, when the first catheter 22 is in a natural state without external force, its distal section 221 bends outward at an angle of 20 to 30 degrees away from the X-axis.

[0110] Given that under the traction of the traction member 223, the distal section 221 of the first catheter 22 can move within a bending angle range of 0 degrees to 90 degrees, therefore, under the joint action of the bending curve and the traction member 223, the bending angle range of the distal section 221 of the first catheter 22 is superimposed, that is, it can move within a bending angle range of 20 degrees to 120 degrees, thereby shaping the second section 322 of the second catheter 32 into a curved form having basically the same curvature as the distal section 221 of the first catheter 22.

[0111] Typically, when a delivery system enters the heart via a transcatheter route, a physician must apply axial driving force and / or torsional force from the proximal end of the catheter to guide the distal end of the catheter, such as the distal end of first catheter 22, the distal end of second catheter 32, and / or the distal end of third catheter 42, to the target area within the heart. The catheter that transmits these forces from the proximal end to the distal end must be rigid enough to be pushed through blood vessels, yet flexible enough to navigate tortuous vessels, and also require sufficient torsional stiffness to transmit the applied torque. Thus, designers must strike a balance between achieving axial stiffness, torsional stiffness, and flexibility.

[0112] In a second embodiment, as shown in FIG13 , a transcatheter delivery system 100 b of a medical device 300 enters the human body via a transcatheter route, such as via the femoral vein, to deliver the medical device 300 to the heart in the body to treat heart disease.

[0113] Specifically, the transcatheter delivery system 100b includes a first delivery device 20, a second delivery device 30, and a third delivery device 40. The first delivery device 20 includes a first handle 21 and a first catheter 22 extending distally from the first handle 21. The first catheter 22 includes a bendable and / or pre-shaped distal section 221. The second delivery device 30 includes a second handle 31 and a second catheter 32 extending distally from the second handle 31. The second catheter 32 extends coaxially through the first delivery device 20. The third delivery device 40 includes a third handle 41 and a third catheter 42 extending distally from the third handle 41. The third catheter 42 includes a distal bendable section 421 (see FIG. 8 ). The first catheter 22 extends coaxially through the third delivery device 40.

[0114] Furthermore, the second catheter 32 is provided with different sections along its axial length to balance the requirements for axial stiffness, torsional stiffness, and flexibility. Specifically, as shown in FIG14 , the second catheter 32 includes a proximal section 323 extending along its axial length. To ensure that the proximal section 323 can simultaneously meet the requirements for torsional stability and support, the proximal section 323 includes a laser-cut tube 36. The second delivery device 30 can deliver the medical device 300 to the target area of ​​the heart within the body through a blood vessel, coordinated by the bending of the distal section 221 and the bendable section 421, while the proximal section 323 remains external to the body. That is, the laser-cut tube 36 in the proximal section 323 will not enter the blood vessel, thereby neither affecting the compliance requirements of the blood vessel nor creating the risk of puncturing the blood vessel, thereby ensuring the safety of the procedure.

[0115] It will be appreciated that, in order to balance the requirements of the transcatheter delivery system 100b for axial stiffness, torsional stiffness, and flexibility, the second catheter 32 is designed as a segmented structure. Specifically, referring to FIG14 , the second catheter 32 also includes an intermediate segment 324 and a distal segment 325 extending along its axial length. The intermediate segment 324 connects the distal segment 325 and the proximal segment 323. The distal segment 325 can be a distal segment with an unchanged outer diameter, as shown in FIG14 , or a distal segment with a changed outer diameter, as shown in FIG2 . As shown in FIG2 , the axial length of the distal segment 325 is greater than the axial length of the second segment 322; that is, the distal segment 325 includes the second segment 322 and a portion of the first segment 321. Preferably, the length of the proximal section 323 ranges from 400 mm to 600 mm, the length of the middle section 324 ranges from 640 mm to 790 mm, and the length of the distal section 325 ranges from 110 mm to 160 mm.

[0116] Please refer to Figures 14 and 15 simultaneously. To ensure uniform support of the proximal section 323 along its axial length and avoid the risk of fracture, in some embodiments, the laser-cut tube 36 has a constant stiffness along its axial length, and its axial length range L6 is 400mm-600mm (see Figure 14), and its thickness range is 0.1mm-0.3mm. Specifically, the laser-cut tube 36 has a plurality of cutting lines 360, and the plurality of cutting lines 360 are evenly spaced around the circumference of the laser-cut tube 36. The plurality of groups of cutting lines 360 are evenly arranged axially on the laser-cut tube 36, and each adjacent group of cutting lines 360 is radially / circumferentially offset.

[0117] In some embodiments, to ensure uniform axial and radial symmetry of the laser-cut tube 36, the cut lines 360 are symmetrically arranged in one of the following patterns: a kidney-shaped pattern 360a, a rugby-shaped pattern 360b, an elliptical pattern (not shown), or a square pattern (not shown). Specifically, as shown in FIG15 , each cut line 360 ​​(including the kidney-shaped pattern 360a and the rugby-shaped pattern 360b) has an aspect ratio of 20, and the axial spacing Z1 between two adjacent cut lines 360 is greater than the radial / circumferential spacing Z2. For example, Z1 can be 3.5 mm, and Z2 can range from 0.9 mm to 1.0 mm.

[0118] Furthermore, a weld end 361 (including weld ends 361a and 361b) with an opening is formed at the farthest end of the laser-cut tube 36 for connection to components in the middle section 324, such as the woven mesh in the middle section 324. The axial length Z3 of the weld end 361 is 13 mm, and the axial distance Z4 between the weld end 361 and the farthest cutting line 360 ​​is 6 mm.

[0119] It will be appreciated that, in order to further balance the requirements of the transcatheter delivery system 100b for axial stiffness, torsional stiffness, and flexibility, in some embodiments, the second catheter 32 is designed as a layered structure. Specifically, referring to Figures 14 and 16 , the wall of the second catheter 32 comprises, radially from the inside out, a first polymeric layer 32a, a first reinforcement layer 32c, and a second polymeric layer 32b. The first polymeric layer 32a and the second polymeric layer 32b can be combined to encapsulate the first reinforcement layer 32c between the first polymeric layer 32a and the second polymeric layer 32b. The first reinforcement layer 32c comprises a laser-cut tube 36 and a braided mesh 37 connected to the distal end of the laser-cut tube 36. Preferably, the laser-cut tube 36 is located in the proximal section 323, and the braided mesh 37 is located in the middle section 324 and the distal section 325.

[0120] Of course, to ensure support at the proximal end of first catheter 22, referring again to FIG. 13 , first catheter 22 further includes a proximal section 222 connected to the proximal end of distal section 221. Proximal section 222 is comprised of a harder material than distal section 221. After transcatheter delivery system 100b delivers medical device 300 via a blood vessel to a target region of the heart within the body, a portion of proximal section 222 is positioned externally, while another portion is positioned internally. The harder material does not include a laser-cut tube to prevent proximal section 222 from puncturing blood vessels or other contacting tissue within the body.

[0121] Similarly, to ensure that the distal section 221 of the first catheter 22 can be positioned at the target area within the heart along a predetermined route, while also preventing the first catheter 22 from contacting and damaging cardiac tissue when extending from the third catheter 42, the first catheter 22 further includes a traction lumen 220 extending at least partially through the proximal section 222 and the distal section 221, as further described in conjunction with Figures 9-12. The distal end of at least one traction member 223 is attached to the distal section 221, and the proximal end of the traction member 223 extends through the traction lumen 220 and is attached to the first handle 21. Furthermore, the distal section 221 of the first catheter 22 is pre-shaped with a curvature. The curvature and the traction member 223 allow the distal section 221 to move within a curvature range of 20 to 120 degrees.

[0122] Of course, in other embodiments, the first conduit 22 and the third conduit 42 may also be designed as a multi-stage layered structure. For details, please refer to the detailed discussion of the second conduit 32 and will not be repeated here.

[0123] In the third embodiment, in order to avoid the defect that the axial distance between the medical device 300 and the distal end of the first catheter 22 is too large in the application scenario as shown in FIG17 , which causes the distal end of the medical device 300 to accidentally touch the inner side of the atrial wall 52 opposite to the atrial septum 51 and thus cause damage to the atrial tissue, the present invention also provides a delivery system 100c for the medical device 300.

[0124] Specifically, referring to Figures 17-20, the delivery system 100c includes a first delivery device 20 and a second delivery device 30. The first delivery device 20 includes a first handle 21 and a first catheter 22 extending distally from the first handle 21. A distal coupler 23 is fixedly disposed at the distal end of the first catheter 22. The second delivery device 30 includes a second handle 31 and a second catheter 32 extending distally from the second handle 31. The second catheter 32 coaxially extends through the first delivery device 20. A protective coupler 35 is fixedly disposed at the distal end of the second catheter 32. The medical device 300 is removably coupled to the protective coupler 35. The distal coupler 23 has an axially extending coupling cavity 230. The outer surface of the protective coupler 35 is formed with a circumferential coupling surface 350. The circumferential coupling surface 350 is capable of circumferentially engaging within the coupling cavity 230 to shorten the axial distance between the medical device 300 and the distal coupler 23.

[0125] Of course, the delivery system 100c can also include a third delivery device 40. The third delivery device 40 includes a third handle 41 and a third catheter 42 extending distally from the third handle 41. The first catheter 22 coaxially extends through the third delivery device 40. Under the manipulation of the third handle 41, the distal end of the third catheter 42 can pass through the atrial septum 51 within the heart and be positioned within the atrium within the heart. Under the manipulation of the first handle 21, the first catheter 22 is guided by the third catheter 42 to be advanced distally and extended beyond the distal end of the third catheter 42 for subsequent manipulation. For example, the first catheter 22 has a flexible distal section 221, which allows for bending of the distal section 221. At this point, the second catheter 32 is housed within the first catheter 22, the protective coupler 35 is housed within the distal coupler 23, and the medical device 300, coupled to the protective coupler 35, is always positioned outside the distal coupler 23.

[0126] Since the circumferential joint surface 350 can be circumferentially engaged in the joint cavity 230 during the process of the first catheter 22 extending out of the third catheter 42, the axial distance of the medical device 300 extending out of the third catheter 42 is shortened, thereby effectively avoiding the defect of the medical device 300 accidentally touching the inner side of the atrial wall 52 and causing damage to the atrial tissue.

[0127] To prevent the protective coupler 35 from entering the lumen of the first conduit 22 through the engagement cavity 230 of the distal coupler 23, as shown in FIG18 , the cross-sectional dimensions of the engagement cavity 230 are larger than the cross-sectional dimensions of the circumferential engagement surface 350, and the cross-sectional dimensions of the circumferential engagement surface 350 are larger than the inner diameter of the first conduit 22. In some embodiments, the cross-sectional dimensions of the engagement cavity 230 and the cross-sectional dimensions of the circumferential engagement surface 350 are both circular; wherein the diameter of the engagement cavity 230 is larger than the cross-sectional diameter of the circumferential engagement surface 350, and the cross-sectional diameter of the circumferential engagement surface 350 is larger than the inner diameter of the first conduit 22.

[0128] Of course, in order to better prevent the protective coupler 35 from entering the lumen of the first conduit 22 through the engagement cavity 230 of the distal coupler 23, a limiting portion 231 is provided within the engagement cavity 230. The limiting portion 231 is capable of limiting the circumferential engagement surface 350 from entering the first conduit 22. Specifically, as shown in FIG19 , the limiting portion 231 is arranged to form a limiting cavity 232. The cross-sectional dimensions of the limiting cavity 232 are smaller than the cross-sectional dimensions of the circumferential engagement surface 350, so that the circumferential engagement surface 350 is limited by the limiting cavity 232 from entering the first conduit 22. Inevitably, the cross-sectional dimensions of the limiting cavity 232 are larger than the outer diameter of the second conduit 32, so that the second conduit 32 can freely pass through the limiting cavity 232, thereby controlling the protective coupler 35 from disengaging from the circumferential engagement of the distal coupler 23 and extending out of the distal coupler 23. In some embodiments, the axial distance S1 between the stopper 231 and the distal opening of the coupling cavity 230 ranges from 0.15 mm to 2.4 mm. The protective coupler 35 can enter or exit the distal coupler 23 through the distal opening of the coupling cavity 230, thereby shortening the axial distance S1. Preferably, S1 is 1.5 mm.

[0129] Furthermore, to ensure the secure attachment of the distal coupler 23 and the protective coupler 35, the distal coupler 23 is further provided with a connecting portion 233 fixedly connected to the first conduit 22, and the protective coupler 35 is further provided with a connecting end 351 fixedly connected to the second conduit 32 (see FIG20 ). Both the connecting portion 233 and the connecting end 351 are tubular in shape, and each tubular sidewall has a plurality of openings 200 (see FIG17 ). When the distal coupler 23 is connected to the first conduit 22 and the protective coupler 35 is connected to the second conduit 32 via hot melt, the hot melt fluid can flow into the plurality of openings 200, thereby strengthening the secure attachment between the two.

[0130] In the application scenario shown in FIG17 , after the first catheter 22 is advanced distally and extends beyond the distal end of the third catheter 42, a further bending adjustment operation is performed on the first catheter 22. Specifically, referring to FIG19 , the first catheter 22 includes a bendable distal section 221, a proximal section 222, and a traction lumen 220 extending at least partially through the proximal and distal sections 222 and 221. A distal pull ring 223b is fixedly disposed on the distal section 221, for example, by heat-sealable attachment to the distal end of the distal section 221. A traction wire 223a is attached at its distal end to the distal pull ring 223b, and its proximal end extends through the traction lumen 220 and is attached to the first handle 21. Under the manipulation of the first handle 21, the traction wire 223a can be pulled and tensioned, and then the distal section 221 is pulled to bend or deform by actuating the traction wire 223a, so as to shape the second catheter 32 into a curved form with basically the same curvature as the distal section 221 of the first catheter 22, and finally drive the medical device 300 to move toward the inner side away from the atrial wall 52 to completely avoid the inner side of the atrial wall 52.

[0131] In some embodiments, the distal coupler 23 is fixedly disposed at the distal end of the distal section 221, and the distal pull ring 223b is disposed within a preset range S2 between the distal section 221 and the proximal end of the distal coupler 23. Preferably, S2 is 0-2 mm.

[0132] As will be appreciated, referring to both Figures 19 and 20 , the second delivery device 30 further includes an axially incompressible coil 33 that coaxially extends through the second catheter 32. Preferably, the coil 33 is a flat wire spring tube. In some embodiments, the medical device 300 includes a valve clip 300a, and the protective coupler 35 further includes a protruding tubular engagement portion 352. The distal end of the tubular engagement portion 352 is removably engaged with the valve clip 300a, and the proximal end of the tubular engagement portion 352 abuts against the distal end of the coil 33.

[0133] Furthermore, the coil 33 defines an axially extending through-lumen 330. A release lever 34 coaxially extends through the coil 33 and the lumen of the tubular joint 352. The release lever 34 can be switched between extending from the distal end of the tubular joint 352 and retracting into the distal end of the tubular joint 352, thereby forcing the valve clip 300a to switch between engaging with and releasing the protective coupler 35. In some embodiments, the cross-sections of the through-lumen 330 and the lumen of the tubular joint 352 are both circular; the inner diameter of the through-lumen 330 is equal to the inner diameter of the lumen of the tubular joint 352, allowing the release lever 34 to move smoothly within the second catheter 32.

[0134] For some applications, the distal coupler 23 and the protective coupler 35 are both made of metal materials, such as stainless steel.

[0135] In a fourth embodiment, the present invention further provides a valve clipping system 100d with interlocking control, which enables an operator to perform various optional operations on a medical device 300, such as a valve clipper 300b, thereby meeting the operator's diverse needs. Specifically, referring to Figures 21 and 22 , the valve clipping system 100d includes a valve clipper 300b, a handle 60, a catheter 70, a first actuator 80, and a second actuator 90. Specifically, the valve clipper 300b includes a forceps arm 301 and a first clip 302 and a second clip 303 that are movable relative to the forceps arm 301. The first actuator 80 is removably coupled to the first clip 302, extends proximally through the catheter 70, and is axially movable relative to the catheter 70. The second actuator 90 is removably coupled to the second clip 303, extends proximally through the catheter 70, and is axially movable relative to the catheter 70. Furthermore, the handle 60 includes a handle housing 61, a first actuation controller 62, a second actuation controller 63, and a linkage member 64. The handle housing 61 is connected to the proximal end of the catheter 70, the first actuation controller 62 is connected to the proximal end of the first actuation element 80, and the second actuation controller 63 is connected to the proximal end of the second actuation element 90. The linkage member 64 is movably coupled between the first actuation controller 62 and the second actuation controller 63, for example, it is rotatably disposed between the first actuation controller 62 and the second actuation controller 63. The linkage member 64 is movable relative to the handle housing 61 to control the first actuation controller 62 and the second actuation controller 63 to move synchronously relative to the linkage member 64.

[0136] Under the action of an external force, the linkage member 63 can be decoupled from the first actuation controller 62 and / or the second actuation controller 63, thereby severing the linkage control between the first actuation controller 62 and the second actuation controller 63 and switching to independent control of each other. The valve clipping system 100d of the present invention not only achieves linkage control of the first clip 302 and the second clip 303, but also enables independent control of the first clip 302 or the second clip 303. This allows the operator to perform a variety of optional operations on the valve clipper 300b, meeting the operator's diverse needs.

[0137] It can be understood that the movement of the linkage member 64 relative to the handle housing 61 can be generated by applying external force to the first actuation controller 62 or the second actuation controller 63, or by directly applying external force to the linkage member 64. Please refer to the subsequent description for details.

[0138] For some applications, the first actuating element 80 and the second actuating element 90 are control wires or control lines, respectively. After one free end of the first actuating element 80 passes through the first clip 302, it folds back proximally to extend through the catheter 70. Both free ends of the first actuating element 80 are connected to the first actuating controller 62. After one free end of the second actuating element 90 passes through the second clip 303, it folds back proximally to extend through the catheter 70. Both free ends of the second actuating element 90 are connected to the second actuating controller 63. Thus, an operator can remove and detach the first actuating element 80 from the first clip 302 and the second actuating element 90 from the second clip 303 by releasing one free end of the first actuating element 80 and pulling the other free end, respectively.

[0139] For other applications, the valve clamp 300b is located outside the distal end of the catheter 70 and is removably engaged with a drive rod (release rod). The drive rod (release rod) can extend through the catheter 70 and be connected to the third actuation controller of the handle 60. The proximal third actuation controller is manipulated to drive the drive rod (release rod) to move relative to the catheter 70, thereby actuating the opening and closing of the distal clamp arm 301 and the disengagement of the valve clamp 300b relative to the drive rod (release rod). Specifically, the clamp arm 301 is a pair of clamp arms that can open and close relative to each other, including a first clamp arm 3011 and a second clamp arm 3012 hinged to the first clamp arm 3011. The first clamp 302 and the second clamp 303 are respectively elastic sheet structures. The first actuating element 80 can be driven by the first actuating controller 62 to move axially relative to the catheter 70 and actuate the first clip 302 to move relative to the first clamp arm 3011, thereby switching between a position close to the first clamp arm 3011 and a position away from the first clamp arm 3011, thereby switching the first clip 302 between a clamping state in which the heart valve is clamped and a deployed state in which the heart valve is separated. The second actuating element 90 can be driven by the second actuating controller 63 to move axially relative to the catheter 70 and actuate the second clip 303 to move relative to the second clamp arm 3012, thereby switching between a position close to the second clamp arm 3012 and a position away from the second clamp arm 3012, thereby switching the second clip 303 between a clamping state in which the heart valve is clamped and a deployed state in which the heart valve is separated.

[0140] In the fourth embodiment, the present invention utilizes the movement of the linkage member 64 to synchronously drive the first and second actuation controllers 62 and 63, thereby controlling the first and second clips 302 and 303 to simultaneously clamp both leaflets of the heart valve. This linkage control method not only facilitates operator control of the valve clipper 300b but also enables synchronized and symmetrical clamping of the two leaflets of the heart valve, ensuring substantially consistent clamping depths after clamping, effectively improving surgical outcomes.

[0141] In some embodiments, the linkage member 64 is rotatably disposed within the handle housing 61, for example, rotatably disposed within the handle housing 61 and respectively coupled to at least the distal portion of the first actuation controller 62 and at least the distal portion of the second actuation controller 63. Meanwhile, the proximal ends of the first actuation controller 62 and the proximal ends of the second actuation controller 63 extend through the handle housing 61 and are respectively exposed outside the handle housing 61.

[0142] Specifically, referring to FIG. 24 , the linkage member 64 includes a first linkage member 641 and a second linkage member 642 coupled to each other. The first linkage member 641 is rotationally coupled to the first actuation controller 62, and the second linkage member 642 is rotationally coupled to the second actuation controller 63. In some applications, the first linkage member 641 and the second linkage member 642 are both rotatable relative to the handle housing 61. The handle housing 61 has a first radial centerline Z8 and a second radial centerline Z9 extending radially and parallel to each other. The first linkage member 641 rotates about the first radial centerline Z8, for example, within the handle housing 61, and the second linkage member 642 rotates about the second radial centerline Z9, for example, within the handle housing 61.

[0143] It is understood that, referring to Figures 23 and 24, the handle housing 61 has an upper housing 611 and a lower housing 612 that cooperate with each other. The upper housing 611 and the lower housing 612 can be connected to each other to define an internal cavity. A first positioning axis 6121 and a second positioning axis 6122 extending from bottom to top are provided at the proximal end of the internal cavity of the lower housing 612 for positioning the first linkage member 641 and the second linkage member 642, respectively. The first positioning axis 6121 and the second positioning axis 6122 extend in the radial direction of the handle housing 61 and are arranged in parallel. In this case, the centerline of the first positioning axis 6121 can be set to the first radial centerline Z8, and the centerline of the second positioning axis 6122 can be set to the second radial centerline Z9.

[0144] In particular, the first linkage member 641 and the second linkage member 642 are mutually meshing gears. At the same time, at least the distal portion of the first actuation controller 62 and at least the distal portion of the second actuation controller 63 are both provided with a rack. The present invention preferably uses this rack-and-gear coupling method to achieve the linkage control of the valve clipping system 100d, thereby achieving high transmission accuracy and greatly ensuring the technical effect of synchronization of the linkage control. For example, referring to Figures 21 and 22, under the transmission control of the rack-and-gear, the first linkage member 641 and the second linkage member 642 will be driven to rotate in opposite directions, while the first actuation controller 62 and the second actuation controller 63 are synchronously driven to move synchronously toward the proximal end or distal end.

[0145] To ensure smooth sliding of the first and second actuation controllers 62, 63 within the handle housing 61, in some embodiments, as shown in FIG25 , the first actuation controller 62 includes a first fixed rod 621 and a first control handle 622 slidably mounted on the first fixed rod 621. The second actuation controller 63 includes a second fixed rod 631 and a second control handle 632 slidably mounted on the second fixed rod 631. Furthermore, a first seal 623 is disposed between the first control handle 622 and the first fixed rod 621, and a second seal 633 is disposed between the second control handle 632 and the second fixed rod 631 to ensure sealing between the first and second actuation controllers 62, 63. For example, at least one sealing ring may be disposed around the proximal outer circumference of the first fixed rod 621 to close the radial gap between the first fixed rod 621 and the first control handle 622, and at least one sealing ring may be disposed around the proximal outer circumference of the second fixed rod 631 to seal the radial gap between the second fixed rod 631 and the second control handle 632.

[0146] In some embodiments, the proximal end of the first actuating element 80 extends through the catheter 70 and the handle housing 61 (including the sealing valve and PI tube located within the handle housing 61), then further extends through the first fixing rod 621 to connect to the first control handle 622, thereby ensuring that the handle 60 is reliably sealed during surgery. The proximal end of the second actuating element 90 extends through the catheter 70 and the handle housing 61 (including the sealing valve and PI tube located within the handle housing 61), then further extends through the second fixing rod 631 to connect to the second control handle 632, thereby further ensuring that the handle 60 is reliably sealed during surgery.

[0147] Given that the specific structures of the first actuation controller 62 and the second actuation controller 63 are the same, the specific structure of the first actuation controller 62 is used as an example for detailed description below. A first proximal rib is provided in the internal cavity of the upper shell 611, and a second proximal rib is symmetrically provided in the internal cavity of the lower shell 612, which are connected to each other to form a first slide groove of the handle shell 61. The first fixed rod 621 is fixedly provided at the distal end of the first slide groove, and the distal end of the first control handle 622 is sleeved outside the first fixed rod 621, and the proximal end extends out of the handle shell 61 for operator control. Under the action of an external force, the first control handle 622 can slide in the first slide groove in a direction away from or close to the first fixed rod 621.

[0148] Please also refer to Figure 26, the first control handle 622 includes a first gripping portion 6221 and a first sliding rod 6222 extending and protruding from the distal end of the first gripping portion 6221. The first gripping portion 6221 is always positioned outside the handle housing 61, and at least the distal portion of the first sliding rod 6222 is sleeved outside the first fixed rod 621. The first control handle 622 is manipulated to actuate the first sliding rod 6222 to slide proximally or distally relative to the first fixed rod 621, so as to switch back and forth between extending the handle housing 61 or retracting the handle housing 61. Specifically, the circumference of the first gripping portion 6221 is provided with anti-slip grooves to facilitate the operator's grip. The first sliding rod 6222 is roughly a hollow rod-shaped structure, and a first rack 620 with a plurality of meshing teeth is arranged axially and extended along the side end of the first sliding rod 6222 to form a first rack 620 having a plurality of meshing teeth for engaging with the meshing teeth of the first linkage member 641.

[0149] In some embodiments of the present invention, the linkage control is disconnected by applying an operator's actuation force to the first actuation controller 62 and / or the second actuation controller 63. As shown in Figures 26 and 27, the first actuation controller 62 can be rotated relative to the handle housing 61 to disengage the coupling, such as engagement, of the first linkage member 641; and / or the second actuation controller 63 can be rotated relative to the handle housing 61 to disengage the coupling, such as engagement, of the second linkage member 641. This simple switching solution, which does not require an additional switching knob, not only makes the overall structure of the handle 60 extremely simple, but also facilitates convenient and easy operation.

[0150] To ensure smoothness and stability when the rack and pinion engage again, only the first actuation controller 62 is rotated to disengage it from the first linkage member 641. However, the first linkage member 641 and the second linkage member 642 remain in meshing. Therefore, when the second actuation controller 63 is pulled toward the proximal end, the first linkage member 641 can idle under the drive of the second linkage member 642 to maintain the meshing state. When it is necessary to switch to linkage control again, the first linkage member 641 only needs to re-engage with the first actuation controller 62, thereby increasing the controllability of the operation.

[0151] Specifically, to ensure that the first actuation controller 62 can smoothly rotate out of engagement with the first linkage member 641, a tooth-shaped feature extending vertically through each meshing tooth of the first rack 620 on the first actuation controller 62 is provided. In the coordinated control state of the valve clipping system 100d, the first rack 620 is engaged with the first linkage member 641. When the first actuation controller 62 is independently controlled to rotate 90 degrees counterclockwise, the first actuation controller 62 disengages from the first linkage member 641, thereby switching to independent control of the first actuation controller 62 and the second actuation controller 63.

[0152] Of course, in other embodiments of the present invention, as shown in Figures 28-30, the handle 60 also includes an unlocking member 65, which is connected to the first linkage member 641 or the second linkage member 642. The unlocking member 65 can be radially displaced along the handle housing 61 under the action of an external force, such as radially displaced along the first radial centerline Z8 or the second radial centerline Z9. At this time, the operator can pull or push the unlocking member 65 to drive the first linkage member 641 or the second linkage member 642 to synchronously shift radially, and then switch between disengaging and reengaging with the first actuating controller 62 or the second actuating controller 63, thereby completing the mutual switching between the linkage control state and the individual control state. The following is an example of the unlocking member 65 being connected to the first linkage member 641.

[0153] Referring to Figures 30 and 31 , the unlocking member 65 includes a knob 651, a connecting rod 652, an elastic member 653, and a stopper 654. One end of the connecting rod 652 extends through the handle housing 61 (specifically, the upper housing 611) to connect to the knob 651 located outside the handle housing 61. The other end is rotatably connected to the first linkage member 641 via the stopper 654. The elastic member 653 is sleeved around the connecting rod 652 and compressed between the inner surface of the handle housing 61 (specifically, the inner surface of the upper housing 611) and the connecting rod 652 / first linkage member 641.

[0154] Specifically, as shown in Figures 32 and 33, the knob 651 includes a cylindrical gripping portion 6511 and a limiting boss 6512 protruding from the gripping portion 6511. The cylindrical gripping portion 6511 is provided with anti-slip grooves on its circumference to facilitate gripping by the operator. Correspondingly, the upper shell 611 is provided with a limiting portion 6110 that cooperates with the knob 651. The limiting portion 6110 is roughly cylindrical and protrudes from the outer surface of the upper shell 611. The upper surface of the limiting portion 6110 is recessed downward to form a limiting groove 6111, and the limiting boss 6512 can be circumferentially limited in the limiting groove 6111. Pull the knob 651 along the direction of the first radial center line Z8 to disengage the circumferential limit of the limiting groove 6111.

[0155] As shown in Figures 34 and 35, the connecting rod 652 is generally slender and rod-shaped. One end of the connecting rod 652 has a pin hole for fixed connection with the knob 651. The other end of the connecting rod 652 is circumferentially protruded with a first skirt 6521 and a second skirt 6522. The first skirt 6521 is used to abut against the elastic member 653, and the second skirt 6522 is used to abut against the first linkage member 641. The first skirt 6521 and the second skirt 6522 are spaced apart on the circumferential side wall of the connecting rod 652 away from the knob 651, with the first skirt 6521 positioned between the second skirt 6522 and the knob 651.

[0156] After the unlocking member 65 is assembled to the first linkage member 641, the end of the connecting rod 652 away from the knob 651 will be connected to the first linkage member 641, completing coaxial assembly with the first linkage member 641. Specifically, after the connecting rod 652 passes through the central channel of the first linkage member 641, the second skirt 6522 and the stopper 654 will radially limit the connecting rod 652 to the first linkage member 641 along the first radial centerline Z8. At this time, the second skirt 6522 and the stopper 654 will respectively abut against the radial sides of the first linkage member 641 to prevent radial displacement. In other words, under the constraints of the second skirt 6522 and the stopper 654, the connecting rod 652 and the first linkage member 641 will not radially shift relative to each other, but can rotate relative to each other about the first radial centerline Z8. It should be noted that the radial direction here refers to the direction along the first radial centerline Z8. For some applications, the end of the connecting rod 652 away from the knob 651 is circumferentially provided with external threads 6523, and the retaining member 654 is designed as a nut with internal threads. The unlocking member 65 utilizes the threaded engagement between the external and internal threads to secure the retaining member 654 to the end of the first linkage member 641.

[0157] At the same time, the other end of the connecting rod 652 extends along the first radial centerline Z8 through the through-hole of the upper housing 611, passing through the hollow inner cavity to the outside, and is fixedly connected to the knob 651 on the outside of the upper housing 611 via a pin. The through-hole is connected to the retaining groove 6111. The knob 651 is circumferentially restrained by the retaining groove 6111 to the upper housing 611.

[0158] In addition, the elastic member 653 is sleeved on the outside of the connecting rod 652 to achieve coaxial assembly with the connecting rod 652. One end of the elastic member 653 abuts against the side of the first skirt 6521 away from the second skirt 6522, and the other end abuts against the inner surface of the upper shell 611. Among them, the elastic member 653 is always in a pre-compression state to ensure that the knob 651 is always in close contact with the limiting portion 6110 under the elastic force of the elastic member 653 to avoid shaking. Of course, in other embodiments, the connecting rod 652 does not include the first skirt 6521, and the elastic member 653 achieves its elastic connection by abutting one end thereof against the second skirt 6522 or the first linkage member 641, and the other end against the inner surface of the upper shell 611.

[0159] To ensure that the first linkage member 641 can maintain engagement with the second linkage member 642 while disengaging from the first actuation controller 62 when the unlocking member 65 is radially pulled, the dimension of the first linkage member 641 on the first radial centerline Z8 can be designed to be smaller than the dimension of the second linkage member 642 on the second radial centerline Z9. Specifically, as shown in Figure 36, the dimension of the first linkage member 641 on the first radial centerline Z8 (i.e., tooth thickness) is defined as h1, and the dimension of the second linkage member 642 on the second radial centerline Z9 (i.e., tooth thickness) is defined as h2. Consequently, h2>h1. Furthermore, the height at which the first linkage member 641 engages with the first actuation controller 62 is defined as h, and the height of the limiting boss 6512 of the knob 651 is defined as H. To ensure that after the unlocking member 65 is radially pulled, the limiting boss 6512 of the knob 651 can rotate to abut against the upper surface of the limiting portion 6110 to achieve stable positioning. During the stable positioning, in order to ensure that the first linkage member 641 is completely disengaged from the first actuation controller 62 but still maintains complete engagement with the second linkage member 642, it is necessary that H>h and h2>H.

[0160] To switch the valve clipping system 100d from the linked control state to the individual control state, the knob 651 can be pulled along the first radial centerline Z8, away from the upper housing 611, as shown in FIG30 . This pulling force causes the limiting boss 6512 to disengage from the limiting groove 6111. Furthermore, driven by the connecting rod 652, the first linkage member 641 is pulled upward along the first radial centerline Z8, disengaging from the first actuation controller 62 while maintaining engagement with the second linkage member 642. At this point, the first actuation controller 62 and the second actuation controller 63 are disengaged, entering the individual control state. Finally, the knob 651 can be rotated to force the limiting boss 6512 against the upper surface of the limiting portion 6110, maintaining the valve clipping system 100d in the individual control state, facilitating subsequent manipulation by the operator.

[0161] In particular, to avoid jamming during the pushing process due to tooth-profile gaps in the rack, for some applications, as shown in FIG37 , a bottom-closed tooth-profile feature 6200 is provided between each meshing tooth of the first rack 620 of the first control handle 622, and a bottom-closed tooth-profile feature is also provided between each meshing tooth of the second rack of the second control handle 632, thereby preserving the smooth surface of the bottom surface of the first sliding rod 6222 and the second sliding rod 6222. Then, during the pushing process of the first actuating controller 62 and the second actuating controller 63, the bottom-closed tooth-profile feature design ensures the smoothness and smoothness of the mating surfaces of the first control handle 622 and the second control handle 632 with the handle housing 61, thereby avoiding the occurrence of jamming.

[0162] It is understood that for some applications, the first actuation controller 62 and the second actuation controller 63 are aligned at an angle, such as in a figure-eight alignment as shown in FIG. 29 and located on either side of the linkage member 64. In this case, the first actuation controller 62 and the second actuation controller 63 are arranged on opposite sides of the central axis of the handle housing 61. This dispersed arrangement is not affected by the layout of the actuation controllers, which not only makes the structural space more flexible, but also prevents interference between the actuation controllers and prevents accidental activation due to confusion.

[0163] In the present invention, in the initial state, the valve clipping system 100d is in a linked control state. In this state, the first linkage member 641, which is rotatable relative to the connecting rod 652, is engaged with the second linkage member 642 and the first actuation controller 62. The knob 651 is circumferentially restrained by the retaining groove 6111 within the upper housing 611, i.e., locked to the upper housing 611 to prevent accidental activation. In this state, proximally pulling or distally pushing the first actuation controller 62 or the second actuation controller 63 achieves synchronized actuation of the first actuation element 30 and the second actuation element 40, thereby linked to control the synchronized movement of the first clip 302 and the second clip 303 of the valve clipper 300b relative to the clamp arm 301.

[0164] When the valve clipping system 100d needs to be switched from the linked control state to the individual control state, the knob 651 is pulled and rotated to force the stop boss 6512 of the knob 651 against the upper surface of the stop portion 6110 of the upper housing 611, thereby maintaining the valve clipping system 100d in the individual control state. At this point, the first linkage member 641 disengages from the first actuation controller 62 but remains engaged with the second linkage member 642. The first actuation controller 62 is unlocked by the first linkage member 641 and enters the individual control state, while the second actuation controller 63 remains engaged with the first and second linkage members and enters the individual control state, with the movements of the two independent of each other. By pulling the first actuation controller 62 and the second actuation controller 63 proximally or pushing them distally, the first actuation element 30 and the second actuation element 40 can be actuated independently, thereby independently controlling the first clip 302 and the second clip 303 of the valve clipper 300b.

[0165] In a fifth embodiment, referring to Figures 38 and 39 , a valve clipping system 100d includes a valve clipper 300b, a catheter 70, a first actuating element 80, a second actuating element 90, and a handle 60. Specifically, the valve clipper 300b includes a clamp arm 301 and a first clip 302 and a second clip 303 that are movable relative to the clamp arm 301. The first actuating element 80 is removably coupled to the first clip 302, extends proximally through the catheter 70, and is axially movable relative to the catheter 70. The second actuating element 90 is removably coupled to the second clip 303, extends proximally through the catheter 70, and is axially movable relative to the catheter 70.

[0166] Furthermore, the handle 60 includes a handle housing 61, a first actuation controller 62, a second actuation controller 63, and a linkage member 64. The handle housing 61 is connected to the proximal end of the catheter 70 and has a central axis X axially aligned with the catheter 70. The first actuation controller 62 is connected to the proximal end of the first actuating element 80, and the second actuation controller 63 is connected to the proximal end of the second actuating element 90. The linkage member 64 connects the first actuation controller 62 and the second actuation controller 63. The first actuation controller 62 has a first axis X1 intersecting with the central axis X, and the second actuation controller 63 has a second axis X2 intersecting with the central axis X. The linkage member 64 can control the first actuation controller 62 to move along the first axis X1 relative to the handle housing 61, and the second actuation controller 63 to move along the second axis X2 relative to the handle housing 61.

[0167] In some embodiments, the angle between the central axis X and the first axis X1 / the second axis X2 ranges from 0 to 90 degrees, preferably 15 degrees.

[0168] In the fifth embodiment, the present invention arranges the first actuation controller 62 and the second actuation controller 63 at an angle to prevent interference. Furthermore, a linkage member 64 is used to control the first and second actuation controllers 62, 63 in a coordinated manner, thereby controlling the first and second clips 302, 303 to simultaneously clamp both leaflets of the heart valve. This not only meets the diverse needs of the operator but also ensures a substantially consistent clamping depth after clamping, thereby guaranteeing a successful surgical procedure.

[0169] To avoid confusion and mis-touch due to being located on the same side of the handle housing 61, in some embodiments, the first axis X1 and the second axis X2 are symmetrically arranged on either side of the central axis X. Furthermore, to ensure bilateral symmetry between the first actuation controller 62 and the second actuation controller 63, the extension of the first axis X1 and the extension of the second axis X2 intersect at point A on the central axis X (see FIG. 38 ).

[0170] Specifically, the linkage member 64 includes a first end 640a and a second end 640b. The first end 640a is movably connected to the first actuation controller 62, and the second end 640a is movably connected to the second actuation controller 63. The linkage member 64 is used to control the first actuation controller 62 to move proximally or distally relative to the first end 640a along the first axis X1, and the second actuation controller 63 to move proximally or distally relative to the second end 640a along the second axis X2.

[0171] In some embodiments, as shown in FIG40 , the linkage member 64 includes a first linkage member 641 and a second linkage member 642 that are meshed with each other. The first linkage member 641 is meshed with at least the distal portion of the first actuation controller 62, and the second linkage member 642 is meshed with at least the distal portion of the second actuation controller 63. To ensure symmetrical meshing, the first linkage member 641 and the second linkage member 642 are meshed on the central axis X. The side of the first linkage member 641 away from the second actuation controller 63 is defined as the first end 640a, and the side of the second linkage member 642 away from the first actuation controller 62 is defined as the second end 640b, for achieving meshing connection. In view of the fact that the above meshing structure and transmission method are consistent with those of the fourth embodiment, they will not be repeated here.

[0172] Of course, in some embodiments of the present invention, as shown in FIG41 , the first actuation controller 62 includes a first fixing rod 621 and a first control handle 622, wherein the first control handle 622 is slidably mounted on the first fixing rod 621 along the first axis X1. The second actuation controller 63 includes a second fixing rod 631 and a second control handle 632, wherein the second control handle 632 is slidably mounted on the second fixing rod 631 along the second axis X2. It will be appreciated that, since the detailed structures of the various components of the valve clipping system 100d, as well as the connection relationships and motion relationships between the components, have been described in the fourth embodiment, they will not be further elaborated here.

[0173] Of course, in other embodiments of the present invention, as shown in FIG42 , the first actuation controller 62 includes only the first control handle 622 without the first fixing rod 621, and the second actuation controller 63 includes only the second control handle 632 without the second fixing rod 631. Specifically, a first guide groove 610a extending along the first axis X1 and a second guide groove 610b extending along the second axis X2 are formed at the proximal end of the handle housing 61, for sliding movement of the distal ends of the first and second control handles 622 and 632, respectively. For example, a first proximal rib can be provided within the internal cavity of the upper housing 611, and a second proximal rib can be symmetrically provided within the internal cavity of the lower housing 612, to form the first and second guide grooves 610a and 610b of the handle housing 61 when connected. The first axis X1 can be the central axis of the first guide groove 610a, and the second axis X2 can be the central axis of the second guide groove 610b. The first actuation controller 62 is capable of axially moving or rotating within the first guide slot 610a along the first axis X1, and the second actuation controller 63 is capable of axially moving or rotating within the second guide slot 610b along the second axis X2. It will be appreciated that, since the detailed structures, inter-component connections, and kinematic relationships of the other components of the valve clipping system 100d have been described in the fourth embodiment, they will not be further elaborated here.

[0174] It is understood that the delivery systems 100a, 100b, 100c, and 100d can be used for mitral valve repair, where the medical device 300 is used to clamp the anterior and posterior leaflets of the mitral valve to prevent mitral regurgitation. Of course, the delivery systems 100a, 100b, 100c, and 100d can also be used for tricuspid valve repair, where the medical device 300 is used to clamp any two adjacent leaflets of the anterior, posterior, or septal leaflets of the tricuspid valve to prevent tricuspid regurgitation. Of course, they can also be used in other cardiac interventional medical devices, which will not be discussed in detail here.

[0175] The foregoing is merely a list of specific embodiments of the present application, intended to enable those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application is not limited to the embodiments shown herein, but is intended to conform to the broadest scope consistent with the principles, novel features, and inventive features of the present application.

Claims

1. A valve clipping system, characterized in that: include: A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm; catheter; a first actuating element and a second actuating element, the first actuating element being removably coupled to the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; The second actuating element is removably coupled to the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; as well as A handle, comprising: a handle housing connected to the proximal end of the catheter; a first actuation controller and a second actuation controller, wherein the first actuation controller is connected to a proximal end of the first actuation element, and the second actuation controller is connected to a proximal end of the second actuation element; a first linkage member and a second linkage member, the first linkage member coupled to the first actuation controller, the second linkage member coupled to the second actuation controller; and An unlocking member is connected to the first linkage member, and the unlocking member can be displaced relative to the second linkage member under the action of an external force to switch between connecting the first actuation controller and the second actuation controller and releasing the connection, thereby controlling the first actuation element and the second actuation element to move synchronously or individually.

2. The valve clipping system according to claim 1, wherein: The unlocking member can drive the first linkage member to shift relative to the second linkage member to drive the first linkage member to switch between coupling to the first actuation controller and releasing the coupling with the first actuation controller, and the first linkage member and the second linkage member always remain coupled.

3. The valve clipping system according to claim 2, wherein: The unlocking member drives the first linkage member to shift, so as to drive the first linkage member to be disconnected from the first actuation controller and continue to maintain the coupling with the second linkage member.

4. The valve clipping system according to claim 3, wherein: The handle housing has a first radial centerline and a second radial centerline extending radially and parallel to each other. The unlocking member can be displaced along the first radial centerline. The size of the first linkage member on the first radial centerline is smaller than the size of the second linkage member on the second radial centerline.

5. The valve clipping system according to any one of claims 1 to 4, characterized in that: The unlocking member includes a knob, a connecting rod, an elastic member and a limit member; one end of the connecting rod extends through the handle housing to be connected to the knob located outside the handle housing, and the other end of the connecting rod is rotatably connected to the first linkage member through the limit member; the elastic member is sleeved on the outside of the connecting rod and compressed between the inner surface of the handle housing and the connecting rod / the first linkage member.

6. The valve clipping system according to claim 5, wherein: The first linkage member has a central channel, and the other end of the connecting rod is circumferentially protruded with a first skirt and a second skirt, and the first skirt is positioned between the second skirt and the knob; one end of the elastic member abuts against the first skirt; the other end of the connecting rod passes through the central channel and is connected to the limit member, and the second skirt and the limit member abut against both sides of the first linkage member to connect the other end of the connecting rod to the first linkage member in a circumferentially rotatable manner.

7. The valve clipping system according to any one of claims 1 to 6, characterized in that: The first linkage member and the second linkage member are gears meshing with each other, and at least the distal end portion of the first actuation controller and at least the distal end portion of the second actuation controller are both provided with racks.

8. A valve clipping system, characterized in that: include: A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm; catheter; a first actuating element and a second actuating element, the first actuating element being removably coupled to the first clip, the first actuating element extending proximally through the catheter and being axially movable within the catheter; The second actuating element is removably coupled to the second clip, the second actuating element extending proximally through the catheter and being axially movable within the catheter; as well as A handle, comprising: a handle housing connected to the proximal end of the catheter; a first actuation controller and a second actuation controller, the first actuation controller being connected to a proximal end of the first actuation element, and the second actuation controller being connected to a proximal end of the second actuation element; and A first linkage member and a second linkage member, the first linkage member is coupled to the first actuation controller, and the second linkage member is coupled to the second actuation controller; the first linkage member and the second linkage member can rotate synchronously relative to the handle housing to linkage control the first actuation controller and the second actuation controller to move synchronously toward the proximal end or the distal end, thereby driving the first actuation element and the second actuation element to move synchronously toward the proximal end or the distal end.

9. The valve clipping system according to claim 8, wherein: The first actuation element and the second actuation element extend in parallel through the conduit and, after being angularly separated at positions adjacent to the first actuation controller and the second actuation controller, each extend angularly through the first actuation controller and the second actuation controller.

10. The valve clipping system according to claim 9, wherein: The first actuation element and the second actuation element are each separated by an angle of 15 degrees and extend through the first actuation controller and the second actuation controller.

11. The valve clipping system according to any one of claims 8 to 10, characterized in that: The first actuation controller includes a first control handle, and the second actuation controller includes a second control handle; the first control handle includes a first grip and a first sliding rod extending from the distal end of the first grip, the first grip is located outside the handle housing, and at least the distal end of the first sliding rod is slidably disposed in the handle housing; the second control handle includes a second grip and a second sliding rod extending from the distal end of the second grip, the second grip is located outside the handle housing, and at least the distal end of the second sliding rod is slidably disposed in the handle housing; the first linkage member is coupled to the first sliding rod, and the second linkage member is coupled to the second sliding rod.

12. The valve clipping system according to claim 11, wherein: The first actuation controller also includes a first fixed rod located in the handle housing, and the second actuation controller also includes a second fixed rod located in the handle housing. The first sliding rod is slidably mounted outside the first fixed rod, and the second sliding rod is slidably mounted outside the second fixed rod.

13. The valve clipping system according to claim 11, wherein: A first rack is formed along a side end of the first sliding rod, and a second rack is formed along a side end of the second sliding rod; the first linkage member and the second linkage member are gears meshing with each other.

14. The valve clipping system according to claim 13, wherein: A tooth-shaped feature with a closed bottom is provided between each meshing tooth of the first rack, and a tooth-shaped feature with a closed bottom is provided between each meshing tooth of the second rack; or A tooth-shaped feature that passes through from top to bottom is provided between each meshing tooth of the first rack, and the first actuation controller can be rotationally actuated relative to the handle housing to force the first rack to disengage from the first linkage member; and / or a tooth-shaped feature that passes through from top to bottom is provided between each meshing tooth of the second rack, and the second actuation controller can be rotationally actuated relative to the handle housing to force the second rack to disengage from the second linkage member.

15. A valve clamping system with linkage control, characterized in that: include: A valve clipper comprising a clamp arm and a first clamp and a second clamp movable relative to the clamp arm; catheter; a first actuating element and a second actuating element, wherein the first actuating element is removably engaged with the first clip, the first actuating element extends proximally through the catheter and is axially movable relative to the catheter; and the second actuating element is removably engaged with the second clip, the second actuating element extends proximally through the catheter and is axially movable relative to the catheter. as well as A handle, comprising: a handle housing connected to the proximal end of the catheter and having a central axis axially aligned with the catheter; a first actuation controller and a second actuation controller, the first actuation controller being connected to a proximal end of the first actuation element, and the second actuation controller being connected to a proximal end of the second actuation element; and a linkage member connecting the first actuation controller and the second actuation controller; The first actuation controller has a first axis intersecting with the central axis, and the second actuation controller has a second axis intersecting with the central axis; the linkage component can linkage control the first actuation controller to move along the first axis relative to the handle housing, and the second actuation controller to move along the second axis relative to the handle housing.

16. The valve clipping system according to claim 15, wherein: The linkage member is rotatably disposed in the handle housing and is respectively coupled to at least a distal end portion of the first actuation controller and at least a distal end portion of the second actuation controller.

17. The valve clipping system according to claim 15, wherein: The linkage member includes a first linkage member and a second linkage member engaged with each other, the first linkage member being engaged with at least a distal end portion of the first actuation controller, and the second linkage member being engaged with at least a distal end portion of the second actuation controller.

18. The valve clipping system according to claim 17, wherein: The first actuation controller can be rotationally actuated relative to the handle housing to disengage the coupling of the first linkage member; and / or the second actuation controller can be rotationally actuated relative to the handle housing to disengage the coupling of the second linkage member.

19. The valve clipping system according to claim 17, wherein: The handle further includes an unlocking member connected to the first linkage member or the second linkage member. The unlocking member can be displaced in the radial direction of the handle housing under the action of an external force.

20. The valve clipping system according to claim 19, wherein: The handle housing has a first radial centerline and a second radial centerline extending radially and parallel to each other. The unlocking member is connected to the first linkage member. The size of the first linkage member on the first radial centerline is smaller than the size of the second linkage member on the second radial centerline.

21. The valve clipping system according to any one of claims 17 to 20, wherein: The first linkage member and the second linkage member are engaged on the central axis.

22. The valve clipping system according to claim 21, wherein: The first axis and the second axis are symmetrically arranged on both sides of the central axis, or an extension line of the first axis and an extension line of the second axis intersect at the central axis.

23. The valve clipping system according to claim 22, wherein: The angle between the central axis and the first axis / the second axis ranges from 0 to 90 degrees.

24. The valve clipping system according to any one of claims 15 to 23, wherein: The first actuation controller includes a first fixed rod and a first control handle, and the first control handle is slidably mounted on the first fixed rod along the first axis; the second actuation controller includes a second fixed rod and a second control handle, and the second control handle is slidably mounted on the second fixed rod along the second axis.

25. A delivery system for a medical device, characterized in that: include: A first delivery device comprising a first handle and a first catheter extending distally from the first handle, wherein the first catheter comprises a bendable distal section; as well as a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device, the second catheter having a first section and a second section with a reduced outer diameter along its axial length, the second section being located distal to the first section; The first handle is manipulated to force the distal section of the first catheter to bend, and the second section of the second catheter can be shaped into a curved shape by the curved distal section and can at least partially recover to its original shape from the curved shape after extending from the curved distal section.

26. The delivery system according to claim 25, wherein The second delivery device further includes an axially incompressible coil extending coaxially through the second catheter, the coil being configured to enhance recovery of the second segment from the bent configuration to the original configuration.

27. The delivery system of claim 25, wherein: The second catheter is capable of extending from the distal end of the distal section and being movable over a stroke distance, and an axial length of the second section is equal to the stroke distance.

28. The delivery system of claim 27, wherein: A distal coupler is fixedly provided at the distal end of the distal section, and the second catheter can sequentially pass through the first catheter and the distal coupler and then move the stroke distance.

29. The delivery system of claim 25, wherein: A distal coupler is fixedly provided at the distal end of the distal section, and a protective coupler is fixedly provided at the distal end of the second section; the distal coupler has an axially through-going coupling cavity, and a circumferential coupling surface is formed on the outer surface of the protective coupler, and the circumferential coupling surface can be circumferentially coupled in the coupling cavity.

30. The delivery system according to any one of claims 25 to 29, wherein: The second section has an axial length greater than an axial length of the distal section.

31. The delivery system according to any one of claims 25 to 29, wherein: The difference in outer diameter between the first section and the second section is in the range of 0.3 mm to 1.05 mm.

32. The delivery system according to any one of claims 25 to 29, wherein: There is a smooth taper between the first section and the second section with a taper distance in the range of 10 mm to 25 mm.

33. The delivery system according to any one of claims 25 to 29, wherein: The second conduit includes a lubricating coating disposed on an outer surface of the second section, and a length of the lubricating coating is equal to an axial length of the second section.

34. The delivery system according to any one of claims 25 to 29, wherein: The delivery system further includes a third delivery device, the third delivery device including a third handle and a third catheter extending distally from the third handle, the third catheter including a bendable section at the distal end, and the first catheter coaxially extending through the third delivery device; The outer surfaces of the second section and at least part of the first section of the second catheter have a continuous lubricating coating, and the length of the lubricating coating is greater than or equal to the sum of the axial length of the second section, the axial length of the distal section and the axial length of the bendable section.

35. The delivery system according to any one of claims 25 to 29, wherein: The first catheter also includes a proximal section and a traction tube cavity extending at least partially through the proximal section and the distal section; the distal end of at least one traction member is attached to the distal section, and the proximal end of the traction member extends through the traction tube cavity and is attached to the first handle; the first handle is manipulated to actuate the traction member to pull the distal section so that the distal section moves within a bending angle range of 0 degrees to 90 degrees, thereby shaping the second section of the second catheter into a curved form having substantially the same curvature as the distal section.

36. The delivery system of claim 35, wherein: The distal section is pre-shaped with a bending curve, and under the joint action of the bending curve and the traction member, the distal section can move within a bending angle range of 20 degrees to 120 degrees, thereby shaping the second section of the second catheter into a curved form with basically the same curvature as the distal section.

37. The delivery system according to any one of claims 25 to 29, wherein: The medical device includes a valve clip that is removably coupled to the second catheter via a release rod; the inner diameter of the first section of the second catheter is equal to the inner diameter of the second section, so that the release rod can pass through the first section and the second section.

38. A transcatheter delivery system for a medical device, characterized in that: include: A first delivery device comprising a first handle and a first catheter extending distally from the first handle, wherein the first catheter comprises a bendable and / or pre-shaped distal section; as well as a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device; as well as A third delivery device, comprising a third handle and a third catheter extending distally from the third handle, the third catheter comprising a bendable section at a distal end, the first catheter coaxially extending through the third delivery device; The second catheter includes a proximal section extending along its axial length, and the proximal section includes a laser-cut tube; the second delivery device is capable of delivering the medical device through blood vessels to a target area of the heart in the body under the bending cooperation of the distal section and the bendable section, and the proximal section is always positioned outside the body.

39. The transcatheter delivery system of claim 38, wherein: The laser cut tube has a constant stiffness along the axial length of the laser cut tube, and its axial length ranges from 400 mm to 600 mm.

40. The transcatheter delivery system of claim 39, wherein: The laser cut tube has a plurality of cutting lines, and the plurality of cutting lines are evenly spaced around the circumference of the laser cut tube; wherein, a plurality of groups of the cutting lines are evenly arranged axially on the laser cut tube, and the cutting lines of each two adjacent groups form a radial / circumferential stagger.

41. The transcatheter delivery system of claim 40, wherein: The cutting pattern is one of a rugby-shaped pattern, a waist-shaped pattern, an oval-shaped pattern, and a square-shaped pattern.

42. The transcatheter delivery system according to any one of claims 38 to 41, wherein: The tube wall of the second catheter radially includes a first polymer layer, a first reinforcement layer and a second polymer layer from the inside to the outside, and the first polymer layer and the second polymer layer can be combined with each other to encapsulate the first reinforcement layer between the first polymer layer and the second polymer layer; wherein the first reinforcement layer includes the laser cutting tube and a woven mesh connected to the distal end of the laser cutting tube.

43. The transcatheter delivery system according to any one of claims 38 to 41, wherein: The first catheter also includes a proximal segment connected to the proximal end of the distal segment, and the proximal segment includes a material that is harder than the distal segment, and the harder material does not include a laser-cut tube; after the catheter delivery system delivers the medical device through a blood vessel to a target area of the heart in the body, a portion of the proximal segment is positioned outside the body and the other portion is positioned inside the body.

44. The transcatheter delivery system of claim 43, wherein: The first catheter also includes a traction tube cavity extending at least partially through the proximal section and the distal section; the distal end of at least one traction member is attached to the distal section, and the proximal end of the traction member extends through the traction tube cavity and is attached to the first handle; the distal section is pre-shaped with a bending curve, and the distal section can move within a bending angle range of 20 degrees to 120 degrees under the combined action of the bending curve and the traction member.

45. A delivery system for a medical device, characterized in that: include: The first delivery device includes a first handle and a first catheter extending distally from the first handle, wherein a distal coupler is fixedly provided at the distal end of the first catheter; as well as a second delivery device comprising a second handle and a second catheter extending distally from the second handle, the second catheter coaxially extending through the first delivery device; a protective coupler fixedly provided at the distal end of the second catheter, the medical device being removably coupled to the protective coupler; The distal coupler has an axially through-going coupling cavity, and the outer surface of the protective coupler is formed with a circumferential coupling surface, which can be circumferentially coupled in the coupling cavity to shorten the axial distance of the medical device relative to the distal coupler.

46. The delivery system of claim 45, wherein: The cross-sectional dimension of the engagement cavity is larger than the cross-sectional dimension of the circumferential engagement surface, and the cross-sectional dimension of the circumferential engagement surface is larger than the inner diameter of the first conduit.

47. The delivery system of claim 46, wherein: The cross-sections of the engaging cavity and the circumferential engaging surface are both circular, the diameter of the engaging cavity is larger than the cross-section diameter of the circumferential engaging surface, and the cross-section diameter of the circumferential engaging surface is larger than the inner diameter of the first conduit.

48. The delivery system of claim 45, wherein: A limiting portion is provided in the coupling cavity, and the limiting portion can limit the circumferential coupling surface from entering the first conduit.

49. The delivery system of claim 48, wherein The limiting portion is surrounded to form a limiting cavity, and the cross-sectional dimension of the limiting cavity is smaller than the cross-sectional dimension of the circumferential joint surface, so that the circumferential joint surface is restricted by the limiting cavity to enter the first conduit.

50. The delivery system of claim 48, wherein The axial distance between the limiting portion and the distal end opening of the engaging cavity ranges from 0.15 mm to 2.4 mm.

51. The delivery system according to any one of claims 45 to 50, wherein: The distal coupler is further provided with a connecting portion fixedly connected to the first catheter, and the protective coupler is further provided with a connecting end fixedly connected to the second catheter. The connecting portion and the connecting end are both tubular, and the side walls of the tubular are provided with a plurality of openings.

52. The delivery system according to any one of claims 45 to 50, wherein: The first catheter includes a bendable distal section, a proximal section and a traction tube cavity extending at least partially through the proximal section and the distal section; a distal pull ring is fixedly provided on the distal section, the distal end of a traction wire is attached to the distal pull ring, the proximal end of the traction wire extends through the traction tube cavity and is attached to the first handle, and the first handle is manipulated to actuate the traction wire to pull the distal section to bend; the distal coupler is fixedly provided at the distal end of the distal section, and the distal pull ring is provided within a preset range of the distal section from the proximal end of the distal coupler.

53. The delivery system according to any one of claims 45 to 50, wherein: The second delivery device also includes an axially incompressible coil that extends coaxially through the second catheter; the medical device includes a valve clip, and the protective coupler also includes a protruding tubular joint, the distal end of which is removably engaged with the valve clip, and the proximal end of the tubular joint is docked with the distal end of the coil.

54. The delivery system of claim 53, wherein: The coil forms an axially extending through cavity, and a release rod coaxially extends through the cavity of the coil and the tubular joint and can be switched between extending the distal end of the tubular joint and retracting the distal end of the tubular joint, thereby forcing the valve clamp to switch between engaging with the protective coupler and releasing the engagement.

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