Valve delivery system

Abstract

Disclosed in the present invention is a valve delivery system, which comprises: a delivery assembly, wherein the delivery assembly comprises a sheathing canal assembly and a pipeline assembly which are sequentially arranged from outside to inside, the sheathing canal assembly comprises a first delivery pipe and a second delivery pipe which are sequentially arranged from outside to inside, a lateral bending adjusting pipe is arranged at a position of the first delivery pipe located at the distal end, an axial bending adjusting pipe is arranged at a position of the second delivery pipe located at the distal end, and the axial bending adjusting pipe is located at a position proximal to the side of the distal end of the lateral bending adjusting pipe relative to the lateral bending adjusting pipe; and a bending adjusting assembly, wherein the bending adjusting assembly comprises a lateral bending adjusting assembly and an axial bending adjusting assembly which are arranged on an operation handle, the lateral bending adjusting assembly is used for controlling the lateral bending adjusting pipe to bend towards both sides of a vertical plane where the pipeline assembly is located, and the axial bending adjusting assembly is used for controlling the axial bending adjusting pipe to bend in the vertical plane where the pipeline assembly is located. Both a bending adjusting function and a step-by-step release function are integrated on the delivery system, such that step-by-step release of a valve can be achieved while a three-way bending adjusting operation is achieved. Therefore, the use performance of the delivery system is expanded, and the operability of the system is further improved.

Description

Valve delivery system Technical Field

[0001] This invention belongs to the field of medical device technology, and specifically relates to a valve delivery system for delivering artificial valves. Background Technology

[0002] The transfemoral mitral valve delivery system, as an emerging valve replacement device, features minimal trauma and rapid recovery; however, it places higher demands on the performance of the product's functional structure. Existing transfemoral mitral valve delivery systems primarily employ a bidirectional bending structure, allowing bending operations only in two directions. This limits the implantation procedure, demands higher surgeon skills, and restricts the precision of valve adjustment, thus impacting the accuracy and reliability of the implantation.

[0003] Summary of the Invention

[0004] The purpose of this invention is to provide a valve delivery system to solve the problems of limited operability, accuracy and reliability of existing valve delivery systems during implantation.

[0005] This invention is achieved through the following technical solution:

[0006] Valve delivery system, including:

[0007] The delivery assembly includes a sheath assembly and a tubing assembly arranged sequentially from the outside to the inside. The sheath assembly includes a first delivery tube and a second delivery tube arranged sequentially from the outside to the inside. A lateral bending tube is provided at the distal end of the first delivery tube, and an axial bending tube is provided at the distal end of the second delivery tube. The axial bending tube is located on the side closer to the distal end of the lateral bending tube than the lateral bending tube. The other ends of the first delivery tube and the second delivery tube are respectively connected to an operating handle. The tubing assembly serves as a carrier for the valve and is used for the installation and setting of the valve on the delivery system.

[0008] The bending assembly includes a lateral bending assembly and an axial bending assembly mounted on an operating handle. The lateral bending assembly controls the lateral bending pipe to bend toward both sides of the vertical plane where the pipeline assembly is located. The axial bending assembly controls the axial bending pipe to bend within the vertical plane where the pipeline assembly is located, and the bending direction of the lateral bending pipe is perpendicular to the bending direction of the axial bending pipe.

[0009] In some embodiments, the lateral bending pipe is a hyaluronic acid tube structure, and guide ribs arranged on both sides along its axial direction are provided on the lateral bending pipe.

[0010] In some embodiments, the axial bending pipe is a hyaluronic acid tube structure, and a guide rib arranged along its axial direction is provided on one side of the axial bending pipe.

[0011] In some embodiments, a release operation assembly is further included, the release operation assembly including a proximal release assembly and a distal release assembly disposed on the operation handle;

[0012] The tubing assembly includes an outer tube, a central tube, and an inner tube arranged sequentially from the outside to the inside. The capsule includes a proximal capsule located at the distal end of the outer tube and a distal capsule located at the distal end of the inner tube. The central tube is provided with a valve connector for installing a valve.

[0013] The proximal release assembly is used to control the axial movement of the outer tube relative to the central tube.

[0014] The distal release assembly is used to control the axial movement of the inner tube relative to the central tube.

[0015] In some embodiments, the operating handle includes a proximal end and a distal end, which are slidably connected at one end to allow the proximal end and the distal end to move relative to each other in the axial direction;

[0016] The tubing assembly is connected to the proximal end, and the tubing assembly is provided with a sac for accommodating the valve; the sheath assembly is connected to the distal end.

[0017] A capsule adjustment assembly is provided between the proximal end and the distal end, and the capsule adjustment assembly is used to control the relative movement between the proximal end and the distal end in the axial direction.

[0018] In some embodiments, the lateral bending assembly, axial bending assembly, capsule adjustment assembly, proximal release assembly, and distal release assembly are arranged sequentially from distal to proximal on the operating handle.

[0019] In some embodiments, the lateral bending assembly includes two sets of lateral bending components arranged opposite to each other, wherein one set of lateral bending components is used to control the lateral bending pipe to bend to one side, and the other set of lateral bending components is used to control the lateral bending pipe to bend to the other side.

[0020] In some embodiments, the lateral bending assembly includes a lateral adjusting tube inclined to the operating handle, a lateral bending knob sleeved on the lateral adjusting tube, and a lateral transmission member disposed within the lateral adjusting tube.

[0021] The lateral transmission component is slidably connected to the lateral adjustment tube, the lateral bending knob is threadedly connected to the lateral adjustment tube, the lateral transmission component is connected to the lateral bending knob, and the rotation of the lateral bending knob drives the lateral transmission component to move in the axial direction along the lateral adjustment tube.

[0022] The lateral transmission component is connected to the far end of the lateral bending pipe via a bending wire.

[0023] In some embodiments, the axial bending assembly includes an axial bending knob sleeved on an operating handle and an axial transmission component disposed within the operating handle. The axial transmission component is slidably connected to the operating handle, and the axial bending knob is threadedly connected to the axial transmission component. The rotation of the axial bending knob drives the axial transmission component to move in the axial direction along the operating handle.

[0024] The axial transmission component is connected to the far end of the axial bending tube via a bending screw.

[0025] In some embodiments, the proximal release assembly includes a proximal adjustment knob sleeved on an operating handle and a proximal transmission member disposed within the operating handle. The proximal transmission member is slidably connected to the operating handle, and the proximal adjustment knob is threadedly connected to the proximal transmission member. The rotation of the proximal adjustment knob drives the proximal transmission member to move in the axial direction along the operating handle.

[0026] The proximal transmission component is connected to the outer tube.

[0027] In some embodiments, the remote release assembly includes a remote adjustment knob disposed at the end of the operating handle and a remote transmission member disposed within the operating handle. The remote transmission member is slidably connected to the operating handle, the remote adjustment knob is rotatably connected to the operating handle, and the remote adjustment knob is threadedly connected to the remote transmission member. The rotation of the remote adjustment knob drives the remote transmission member to move in the axial direction along the operating handle.

[0028] The remote transmission component is connected to the inner tube.

[0029] In some embodiments, a center tube limiting component is further included, which is used to fix the center tube to the operating handle.

[0030] In some embodiments, the outer tube, the central tube, and the inner tube are respectively provided with curved sections near their distal ends, and the curved sections are of a hyaluronic acid tube structure.

[0031] In some embodiments, the curved section is provided with connecting ribs arranged continuously along its axial direction on one side, and the connecting ribs are located on the same straight line.

[0032] In some embodiments, the curved segment includes a first curved portion on the distal side and a second curved portion on the proximal side, the first curved portion and the second curved portion being connected at one end, and the spiral line cutting density of the first curved portion being greater than the spiral line cutting density of the second curved portion.

[0033] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0034] 1) This invention employs a combination of lateral bending tubes and axial bending tubes, with two sets of lateral bending components adjusting the lateral bending tubes in two directions horizontally and an axial bending assembly adjusting the axial bending tubes in the vertical direction. This enables flexible adjustment of the valve in three directions during implantation, improving the operability of the valve implantation process, reducing the requirements for the surgeon's operation, achieving precise valve adjustment, and ensuring the accuracy and reliability of the implantation operation.

[0035] 2) This invention integrates bending adjustment, overall bladder adjustment and step-by-step release functions into the delivery system. While realizing three-way bending operation, it can realize rapid pushing, retrieval and step-by-step release of the valve, which expands the performance of the delivery system and further improves the operability of the system.

[0036] 3) The present invention designs and lays out the bending assembly and the release operation assembly to make the force distribution on the operating handle more reasonable during the implantation operation, so that the operator can get better feedback during the operation and facilitate the precise adjustment of the system during the operation, thus providing a reliable guarantee for the accuracy and stability of valve implantation operation.

[0037] 4) The present invention designs the structure of the lateral bending pipe and the axial bending pipe to ensure their bending performance while taking into account the structural strength of the bending pipe and the guiding performance of the bending direction during operation.

[0038] 5) The tubing assembly of the present invention adopts a combined hyaluronic acid tube structure, which gives it different bending characteristics at different positions, and can better meet the bending operation requirements of the bending tube; at the same time, combined with the setting of connecting ribs on the hyaluronic acid tube structure, the tubing assembly has good stability during the delivery process, and can well meet the requirements of tubing structure strength in valve inlet and outlet operations. Attached Figure Description

[0039] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings in the embodiments will be briefly described below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation on the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0040] Figure 1 is a schematic diagram of the valve delivery system in an embodiment of the present invention.

[0041] Figure 2 is a partial schematic diagram of point A in Figure 1.

[0042] Figure 3 is a front view of the valve delivery system structure in an embodiment of the present invention.

[0043] Figure 4 is a partial schematic diagram of point B in Figure 3.

[0044] Figure 5 is a cross-sectional view of the valve delivery system in an embodiment of the present invention.

[0045] Figure 6 is a partial schematic diagram of point C in Figure 5.

[0046] Figure 7 is a partial schematic diagram of point D in Figure 5.

[0047] Figure 8 is a schematic diagram of the axial bending assembly of the valve delivery system in an embodiment of the present invention.

[0048] Figure 9 is a partial schematic diagram of point E in Figure 5.

[0049] Figure 10 is a partial schematic diagram of point G in Figure 5.

[0050] Figure 11 is another cross-sectional view of the valve delivery system in an embodiment of the present invention.

[0051] Figure 12 is a partial schematic diagram of point H in Figure 11.

[0052] Figure 13 is a schematic diagram of the proximal release assembly of the valve delivery system in an embodiment of the present invention.

[0053] Figure 14 is a schematic diagram of the distal release assembly of the valve delivery system in an embodiment of the present invention.

[0054] Figure 15 is a schematic diagram of the outer tube / central tube / inner tube structure of the valve delivery system in an embodiment of the present invention.

[0055] Figure 16 is a front view of the outer tube / central tube / inner tube structure of the valve delivery system in an embodiment of the present invention.

[0056] Figure 17 is a partial schematic diagram of point F in Figure 16.

[0057] Wherein: 10. Operating handle; 11. Distal end; 12. Proximal end; 101. First sliding sleeve; 102. Second sliding sleeve; 20. Delivery assembly; 21. First delivery pipe; 22. Second delivery pipe; 23. Lateral bending pipe; 24. Axial bending pipe; 25. Outer pipe; 26. Central pipe; 27. Inner pipe; 28. Proximal capsule; 29. ​​Distal capsule; 210. Valve connector; 201. Guide rib; 202. Double-hole crossbeam; 203. Central pipe connector; 204. Insert connector; 205. Bending section; 251. Connecting rib; 252. First bending part; 253. Second bending part; 30. Bending assembly; 31. Lateral bending assembly; 311. Lateral bending tube; 312. Lateral bending knob; 313. Lateral transmission component; 32. Axial bending assembly; 321. Axial bending knob; 322. Axial transmission component; 40. Release operation assembly; 41. Proximal release assembly; 411. Proximal adjustment knob; 412. Proximal transmission component; 42. Distal release assembly; 421. Distal adjustment knob; 422. Distal transmission component; 50. Bladder body adjustment assembly; 51. Bladder body adjustment knob; 52. Transmission gear. Detailed Implementation

[0058] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are some embodiments of the present invention, but not all embodiments.

[0059] In the following description, the terms "distal" and "proximal" are used with reference to the operator. The end closer to the operator or further from the patient can be considered "proximal," while the end further from the operator or closer to the patient can be considered "distal."

[0060] To address the operability issues of existing delivery systems, referring to Figures 1, 2, 3, and 5, in some embodiments, the valve delivery system includes:

[0061] The delivery assembly 20 includes a sheath assembly and a tubing assembly arranged sequentially from the outside to the inside. The sheath assembly includes a first delivery pipe 21 and a second delivery pipe 22 arranged sequentially from the outside to the inside. A lateral bending pipe 23 is provided at the distal end of the first delivery pipe 21, and an axial bending pipe 24 is provided at the distal end of the second delivery pipe 22. The axial bending pipe 24 is located on the side closer to the distal end of the lateral bending pipe 23. The other ends of the first delivery pipe 21 and the second delivery pipe 22 are respectively connected to the operating handle 10. The tubing assembly serves as a carrier for the valve and is used for the installation and setting of the valve on the delivery system.

[0062] The bending assembly 30 includes a lateral bending assembly 31 and an axial bending assembly 32, both mounted on an operating handle. The lateral bending assembly 31 includes two lateral bending components symmetrically arranged on the operating handle. These components control the bending of the lateral bending pipe in opposite directions on the vertical plane containing the pipe assembly. Specifically, one set of lateral bending components adjusts and controls the bending of the lateral bending pipe in one direction, while the other set adjusts and controls the bending of the lateral bending pipe in the opposite direction. The axial bending assembly 32 controls the bending of the axial bending pipe within the vertical plane containing the pipe assembly, specifically bending the axial bending pipe towards its proximal end in the vertical direction. The bending direction of the lateral bending pipe is perpendicular to the bending direction of the axial bending pipe.

[0063] In some embodiments, referring to FIG6, the axial bending tube 24 is a thiocyanate tube structure, and a guide rib 201 arranged along its axial direction is provided on one side of the axial bending tube 24. The axial bending tube 24 realizes the large bending operation of the delivery system. It adopts a unidirectional bending thiocyanate tube structure. When the sac containing the valve passes through the interatrial septum and enters the left atrium, due to the narrow space and the close position of the sac to the axial bending tube, the radius of rotation is small. At this time, the large bending characteristic of the axial bending tube is utilized to facilitate the initial positioning of the sac at the valve annulus.

[0064] In some embodiments, referring to FIG6, the lateral bending pipe 23 is a hyaluronic acid tube structure, and guide ribs 201 arranged along its axial direction are provided on both sides of the lateral bending pipe 23. The lateral bending pipe adopts a spiral structure for lateral bending of the system. The lateral bending pipe is provided with continuous guide ribs on both sides, which can guide the bending deformation to both sides while taking into account the structural strength of the bending pipe, thus ensuring the stability of the bending operation of the bending pipe.

[0065] By employing a combination of lateral and axial adjustment tubes, and using two sets of lateral adjustment components to adjust the lateral adjustment tube in two directions horizontally, and an axial adjustment assembly to adjust the axial adjustment tube in the vertical direction, flexible adjustment of the valve in three directions is achieved during the implantation procedure, thus improving the operability of the valve implantation process.

[0066] In some embodiments, referring to FIG7, the lateral bending assembly includes a lateral adjustment tube 311 inclined to the operating handle, a lateral bending knob 312 sleeved on the lateral adjustment tube, and a lateral transmission member 313 disposed in the lateral adjustment tube.

[0067] The lateral transmission component 313 is slidably connected to the lateral adjustment tube 311, and the lateral bending knob 312 is threadedly connected to the lateral adjustment tube 311. The lateral transmission component 313 is connected to the lateral bending knob 312, and the lateral transmission component is driven to move in the axial direction along the lateral adjustment tube by rotating the lateral bending knob.

[0068] The lateral transmission component 313 is connected to the far end of the lateral bending pipe 23 via a bending screw.

[0069] Referring to Figure 6, a double-hole crossbeam 202 is installed at the far end of the lateral bending pipe 23. One end of the bending wires of the two lateral bending components is connected to the double-hole crossbeam 301 (the bending wires are not shown in the figure), and the other end is connected to the corresponding lateral transmission component. In this way, by rotating the lateral bending knob, the lateral transmission component is driven to move, and the bending wires apply a tensile force to the lateral bending pipe to one side, causing the lateral bending pipe to bend to one side, thus realizing the bending operation of the conveyor assembly in the left and right directions. The bending wires and the double-hole crossbeam can be connected by overlapping or welding. The overlapping connection method has better stability and reliability compared with other methods.

[0070] In some embodiments, referring to FIG8, the axial bending assembly 32 includes an axial bending knob 321 sleeved on the operating handle and an axial transmission member 322 disposed in the operating handle. The structure of the axial bending knob 321 sleeved on the operating handle allows the axial adjustment knob to rotate around the axis of the operating handle. At the same time, by setting a limiting structure at both ends of the axial bending knob on the operating handle, the axial bending knob will not move in the axial direction. The axial transmission member 322 is slidably connected to the operating handle 10, and the axial bending knob 321 is threadedly connected to the axial transmission member 322. The rotation of the axial bending knob drives the axial transmission member to move in the axial direction along the operating handle.

[0071] The axial transmission component 322 is connected to the far end of the axial bending tube 24 via a bending screw.

[0072] Similarly, a double-hole crossbeam 202 is provided at the far end of the axial bending pipe 24. The double-hole crossbeam is connected to the axial transmission component by a bending screw. The bending operation of the system in the vertical direction is realized by adjusting the axial bending knob.

[0073] The bending assembly on the operating handle adopts an ergonomic design. In the layout design of the lateral bending components, two lateral bending components are symmetrically arranged on both sides of the operating handle. Combined with the setting of the axial bending assembly, the bending operation is made simpler for the operator by reasonably setting each bending knob, and can effectively avoid misoperation.

[0074] Meanwhile, based on the cooperation between each bending knob and other components, as well as the connection structure between the operating handles, each knob will not shift in the axial direction when rotated, ensuring the stability and reliability of the adjustment operation.

[0075] In some embodiments, referring to FIG11, the operating handle 10 includes a proximal end 12 and a distal end 11, which are slidably connected at one end, allowing the proximal and distal ends to move relative to each other in the axial direction. A tubing assembly is connected to the proximal end, and a sac for receiving and loading the valve is provided on the tubing assembly. A sheath assembly is connected to the distal end. A sac adjustment assembly is provided between the proximal and distal ends, and the sac adjustment assembly is used to control the relative movement between the proximal and distal ends in the axial direction. Thus, when adjusting the relative movement between the proximal and distal ends via the sac adjustment assembly, since the tubing assembly for setting the sac is connected to the proximal end and the sheath assembly is connected to the distal end, the relative movement between the proximal and distal ends allows the sac to move relative to the sheath assembly as a whole, thereby enabling overall adjustment of the sac position and achieving overall, rapid pushing or retraction of the sac.

[0076] As one possible embodiment, as shown in Figures 10 and 12, a first sliding sleeve 101 is provided at one end of the distal end 11, and a second sliding sleeve 102 is provided at one end of the proximal end 12. The second sliding sleeve 102 is fitted inside the first sliding sleeve 101, forming a sliding connection between the distal and proximal ends. The capsule adjustment assembly includes a capsule adjustment knob 51 sleeved on the first sliding sleeve 101 and a transmission tooth 52 provided on the second sliding sleeve 102. The transmission tooth 52 passes through the first sliding sleeve 101 and forms a threaded transmission connection with the capsule adjustment knob 51. Thus, rotating the capsule adjustment knob drives relative sliding between the proximal and distal ends.

[0077] Based on the valve release method, valve delivery systems currently mainly have unidirectional release and bidirectional release methods. Bidirectional release can achieve step-by-step release of the valve, making the valve release operation more stable. At the same time, the step-by-step release design helps the operator to locate the valve before release, and step-by-step release has smaller requirements for the anatomical size of the atria and ventricles, and may cause less harm to the patient.

[0078] Although step-by-step release has obvious advantages in application, implementing step-by-step release function in a conveyor system, or making the system have both bending adjustment function and step-by-step release function at the same time, has caused great difficulties in the structural design of the conveyor system due to the limitations and requirements of the working environment, safety, reliability and other aspects of the conveyor system.

[0079] In some embodiments, in conjunction with the structural configuration of the piping assembly, a corresponding release operation assembly is provided on the operating handle to control the piping assembly and realize the step-by-step release function of the system.

[0080] Specifically, the release operation assembly 40 includes a proximal release assembly 41 and a distal release assembly 42 disposed on the operation handle;

[0081] Referring to Figure 4, the tubing assembly includes an outer tube 25, a central tube 26, and an inner tube 27 arranged sequentially from the outside to the inside. The capsule includes a proximal capsule 28 located at the distal end of the outer tube 25 and a distal capsule 29 located at the distal end of the inner tube 27. A cavity for accommodating the valve is formed between the proximal capsule 28 and the distal capsule 29. A valve connector 210 for installing the valve is provided on the central tube 26.

[0082] The proximal release assembly 41 is used to control the movement of the outer tube 25 relative to the central tube 26 in its axial direction;

[0083] The distal release assembly 42 is used to control the movement of the inner tube 27 relative to the central tube 26 in its axial direction.

[0084] During the delivery operation, the valve is placed on the valve connector and housed in the cavity formed by the proximal and distal capsules. After the valve is delivered to the implantation site, the inner cannula is controlled to move distally through the distal release assembly to release the valve distally. The outer cannula is controlled to move proximally through the proximal release assembly to release the valve proximally, thereby achieving the stepwise release of the valve.

[0085] Existing valve delivery systems employ either electrically controlled or large-wheel mechanical control methods. While electrically controlled systems can increase stability during valve induction and release to some extent, they reduce the operator's tactile feedback, providing less intuitive control. Large-wheel mechanical control systems, on the other hand, involve axial movement in addition to rotation during valve induction and release, significantly impacting the stability and accuracy of the operator's manipulation.

[0086] In some embodiments, referring to FIG13, the proximal release assembly 41 includes a proximal adjustment knob 411 sleeved on the operating handle and a proximal transmission member 412 disposed in the operating handle. The proximal transmission member 412 is slidably connected to the operating handle 10, and the proximal adjustment knob 411 is threadedly connected to the proximal transmission member 412. The rotation of the proximal adjustment knob drives the proximal transmission member to move in the axial direction along the operating handle. Similarly, the structure of the proximal adjustment knob 411 sleeved on the operating handle allows the proximal adjustment knob to rotate around the axis of the operating handle. At the same time, the structure of the proximal adjustment knob at both ends of the operating handle provides a limiting structure to prevent the proximal adjustment knob from moving in the axial direction.

[0087] The proximal drive component 322 is connected to the outer tube 25.

[0088] In some embodiments, referring to FIG14, the distal release assembly 42 includes a distal adjustment knob 421 disposed at the proximal end of the operating handle and a distal transmission member 421 disposed within the operating handle. The distal transmission member 422 is slidably connected to the operating handle 10, the distal adjustment knob 421 is rotatably connected to the operating handle 10, and the distal adjustment knob 421 is threadedly connected to the distal transmission member 422. The rotation of the distal adjustment knob drives the distal transmission member to move in the axial direction along the operating handle. Similarly, the structure of the distal adjustment knob sleeved on the operating handle allows the distal adjustment knob to rotate around the axis of the operating handle. At the same time, the structure of the distal adjustment knob at both ends of the operating handle provides a limiting structure to prevent the distal adjustment knob from moving in the axial direction.

[0089] The remote transmission component 422 is connected to the inner tube 27.

[0090] Similarly, based on the cooperation between each adjustment knob and other components, as well as the connection structure between the operating handles, the knobs will not shift in the axial direction when rotated, ensuring the stability and reliability of the adjustment operation.

[0091] In some embodiments, the conveying system further includes a central tube limiting assembly for fixing the central tube to the operating handle. Referring to FIG9, the central tube limiting assembly includes a central tube connector 203 disposed within the operating handle. The central tube connector 203 is movably disposed within the operating handle 10. The proximal end of the central tube 203 is fixedly connected to the central tube connector 203. The central tube connector 203 is connected to the operating handle 10 via a connector 204. The connector 204 is fixedly inserted into the operating handle and into the central tube connector, thereby fixing the central tube connector onto the operating handle.

[0092] Based on the above structure, the system has achieved a good integration of the three-way bending function component and the step-by-step release function component in the conveying system through the structural design of the conveying assembly, bending assembly, and release operation assembly.

[0093] In some embodiments, referring to FIG5, the lateral bending assembly 31, the axial bending assembly 31, the bladder bending assembly, the proximal release assembly 41, and the distal release assembly 42 are arranged sequentially from the distal end to the proximal end on the operating handle 10.

[0094] By adjusting the arrangement of the bending assembly and the release assembly on the operating handle, the internal stress generated during valve deployment and release is completely concentrated at the proximal end of the operating handle, while the internal stress generated during bending is mainly concentrated at the distal end of the operating handle. This makes the force distribution on the operating handle more reasonable during implantation, allowing the surgeon to receive better feedback and providing a reliable guarantee for the accuracy and stability of the operation. It also prevents the operating handle from deforming under stress.

[0095] In existing valve delivery systems, the internal tubing components typically use braided reinforced tubing, which limits the flexibility of valve position adjustment and also affects the operability and accuracy of valve implantation.

[0096] In some embodiments, referring to Figures 15, 16 and 17, the outer tube 25, the central tube 26 and the inner tube 27 are respectively provided with a bending section 205 near their far ends, and the bending section 205 is a hyaluronic acid tube structure.

[0097] Referring to Figure 1, the curved section adopts a spiral-shaped hyaluronic acid tube structure. Compared with the braided tube structure, the outer tube, central tube, and inner tube have better follow-up bending performance when positioned near the capsule, thus making the adjustment of the valve implantation position more flexible.

[0098] In some embodiments, connecting ribs 251 are provided on one side of the curved section 205, continuously arranged along its axial direction, and the connecting ribs 251 are located on the same straight line. The provision of connecting ribs on the hyaluronic acid tube structure enables the tubing assembly to have good stability during delivery, and can well meet the requirements of tubing structural strength in valve induction and release operations.

[0099] In some embodiments, the bending section includes a first bending portion 252 on the distal side and a second bending portion 253 on the proximal side. The first bending portion 252 and the second bending portion 253 are connected at one end, and the helical cutting density of the first bending portion 252 is greater than that of the second bending portion 252. Referring to Figure 14, the helical cutting density refers to the fact that the smaller the spacing between the cutting grooves on the sodium hypochlorite tube, the higher the density; and the larger the spacing between the cutting grooves on the sodium hypochlorite tube, the lower the density. When the density is higher, the corresponding sodium hypochlorite tube structure is usually more prone to bending deformation. Here, a combined sodium hypochlorite tube structure is used, which gives it different bending characteristics at different positions, and can better meet the bending operation requirements of the bending tube.

[0100] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., used to indicate the orientation or positional relationship are based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship that the product of this invention is usually placed in during use. They are only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0101] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of this invention does not imply that the components are required to be absolutely horizontal or suspended, but rather that they can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical," and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0102] In the description of this invention, it should also be noted that, unless otherwise explicitly specified and limited, the terms "set," "install," "connect," and "link" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0103] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Any simple modifications or equivalent changes made to the above embodiments based on the technical essence of the present invention shall fall within the protection scope of the present invention.

Claims

1. A valve delivery system, characterized in that, include: The delivery assembly includes a sheath assembly and a tubing assembly arranged sequentially from the outside to the inside. The sheath assembly includes a first delivery tube and a second delivery tube arranged sequentially from the outside to the inside. A lateral bending tube is provided at the distal end of the first delivery tube, and an axial bending tube is provided at the distal end of the second delivery tube. The axial bending tube is located on the side closer to the distal end of the lateral bending tube than the lateral bending tube. The other ends of the first delivery tube and the second delivery tube are respectively connected to an operating handle. The tubing assembly serves as a carrier for the valve and is used for the installation and setting of the valve on the delivery system. The bending assembly includes a lateral bending assembly and an axial bending assembly mounted on an operating handle. The lateral bending assembly controls the lateral bending pipe to bend toward both sides of the vertical plane where the pipeline assembly is located. The axial bending assembly controls the axial bending pipe to bend within the vertical plane where the pipeline assembly is located, and the bending direction of the lateral bending pipe is perpendicular to the bending direction of the axial bending pipe.

2. The valve delivery system according to claim 1, characterized in that, The lateral bending pipe is a hyaluronic acid tube structure, and guide ribs are arranged on both sides of the lateral bending pipe along its axial direction.

3. The valve delivery system according to claim 1, characterized in that, The axial bending pipe is a hyaluronic acid tube structure, and a guide rib arranged along its axial direction is provided on one side of the axial bending pipe.

4. The valve delivery system according to claim 1, characterized in that, It also includes a release operation assembly, which includes a proximal release assembly and a distal release assembly disposed on the operation handle; The tubing assembly includes an outer tube, a central tube, and an inner tube arranged sequentially from the outside to the inside. The capsule includes a proximal capsule located at the distal end of the outer tube and a distal capsule located at the distal end of the inner tube. The central tube is provided with a valve connector for installing a valve. The proximal release assembly is used to control the axial movement of the outer tube relative to the central tube. The distal release assembly is used to control the axial movement of the inner tube relative to the central tube.

5. The valve delivery system according to claim 1 or 4, characterized in that, The operating handle includes a proximal end and a distal end, which are slidably connected at one end to allow the proximal end and the distal end to move relative to each other in the axial direction. The tubing assembly is connected to the proximal end, and the tubing assembly is provided with a sac for accommodating the valve; the sheath assembly is connected to the distal end. A capsule adjustment assembly is provided between the proximal end and the distal end, and the capsule adjustment assembly is used to control the relative movement between the proximal end and the distal end in the axial direction.

6. The valve delivery system according to claim 5, characterized in that, The lateral bending assembly, axial bending assembly, capsule adjustment assembly, proximal release assembly, and distal release assembly are arranged sequentially from distal to proximal on the operating handle.

7. The valve delivery system according to claim 1 or 4, characterized in that, The lateral bending assembly includes two sets of lateral bending components arranged opposite to each other. One set of lateral bending components is used to control the lateral bending pipe to bend to one side, and the other set of lateral bending components is used to control the lateral bending pipe to bend to the other side.

8. The valve delivery system according to claim 7, characterized in that, The lateral bending assembly includes a lateral adjustment tube inclined to the operating handle, a lateral bending knob sleeved on the lateral adjustment tube, and a lateral transmission component disposed inside the lateral adjustment tube. The lateral transmission component is slidably connected to the lateral adjustment tube, the lateral bending knob is threadedly connected to the lateral adjustment tube, the lateral transmission component is connected to the lateral bending knob, and the rotation of the lateral bending knob drives the lateral transmission component to move in the axial direction along the lateral adjustment tube. The lateral transmission component is connected to the far end of the lateral bending pipe via a bending wire.

9. The valve delivery system according to claim 1 or 4, characterized in that, The axial bending assembly includes an axial bending knob sleeved on the operating handle and an axial transmission component disposed inside the operating handle. The axial transmission component is slidably connected to the operating handle, and the axial bending knob is threadedly connected to the axial transmission component. The rotation of the axial bending knob drives the axial transmission component to move in the axial direction along the operating handle. The axial transmission component is connected to the far end of the axial bending tube via a bending screw.

10. The valve delivery system according to claim 4, characterized in that, The proximal release assembly includes a proximal adjustment knob sleeved on the operating handle and a proximal transmission component disposed inside the operating handle. The proximal transmission component is slidably connected to the operating handle, and the proximal adjustment knob is threadedly connected to the proximal transmission component. The rotation of the proximal adjustment knob drives the proximal transmission component to move in the axial direction along the operating handle. The proximal transmission component is connected to the outer tube.

11. The valve delivery system according to claim 4, characterized in that, The remote release assembly includes a remote adjustment knob disposed at the end of the operating handle and a remote transmission component disposed within the operating handle. The remote transmission component is slidably connected to the operating handle, the remote adjustment knob is rotatably connected to the operating handle, and the remote adjustment knob is threadedly connected to the remote transmission component. The rotation of the remote adjustment knob drives the remote transmission component to move in the axial direction along the operating handle. The remote transmission component is connected to the inner tube.

12. The valve delivery system according to any one of claims 4, 10, or 11, characterized in that, It also includes a central tube limiting assembly, which is used to fix the central tube to the operating handle.

13. The valve delivery system according to claim 4, characterized in that, The outer tube, central tube, and inner tube are each provided with a curved section near their distal ends, and the curved section is a hyaluronic acid tube structure.

14. The valve delivery system according to claim 13, characterized in that, The curved section is provided with connecting ribs arranged continuously along its axial direction on one side, and the connecting ribs are located on the same straight line.

15. The valve delivery system according to claim 14, characterized in that, The curved section includes a first curved portion on the distal side and a second curved portion on the proximal side, the first curved portion and the second curved portion are connected at one end, and the spiral line cutting density of the first curved portion is greater than that of the second curved portion.

Images