Hidden trigger interventional delivery system

Abstract

The present application relates to a hidden trigger type interventional delivery system, comprising: a catheter assembly, comprising a core tube and an outer sheath located on the periphery of the core tube; a first handle, comprising a support body and a connector mounted on the support body that slides axially and is limited circumferentially, the proximal end of the outer sheath being slidably connected to the support body; a second handle, located at the proximal end of the first handle and rotatably mounted on the connector, the core tube passing through the connector and fixedly connected to the second handle; a rotation locking mechanism for limiting or allowing the rotation of the second handle, the rotation locking mechanism comprising a locking member, an operating hole being provided on the outer surface of the second handle for a force-applying member to extend into the second handle and push the locking member toward an unlocked state. The hidden trigger type interventional delivery system of the present application improves the structure of the control handle, and the trigger members of some functions are hidden, which can avoid unexpected misoperation and improve the fault tolerance of the system.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a hidden trigger-type interventional delivery system. Background Art

[0002] The interventional delivery system for artificial implants includes a control handle configured at the proximal end of the interventional delivery system for operation and a catheter assembly extending from the control handle to the distal end. The catheter assembly generally includes multiple relatively movable pipes or rods, pull wires, etc., which are used to cooperate with each other to complete the delivery, posture adjustment, release or recovery of the artificial implant.

[0003] With the demand for improved functions, the driving mechanism or locking mechanism on the control handle has become increasingly complex, and the tolerance for operational errors has gradually decreased, which has invisibly increased the operator's skill requirements and learning costs. In the existing technology, two locks are usually set for more important or low-tolerance operations, but the two locks will increase the structural complexity of the control handle and require additional space optimization design. Summary of the Invention

[0004] The present application provides an interventional delivery system that further improves safety and avoids misoperation, while also taking into account structural simplicity and space optimization.

[0005] The present application discloses a hidden trigger-type interventional delivery system having a distal end and a proximal end opposite to each other and an axial direction extending between the distal end and the proximal end. The interventional delivery system comprises:

[0006] The catheter assembly comprises a core tube and an outer sheath tube located outside the core tube;

[0007] The first handle comprises a support body and a connecting piece which is mounted on the support body and slides in the axial direction and is limited in the circumferential direction, wherein the proximal end of the outer sheath is slidably connected to the support body;

[0008] a second handle, located at the proximal end of the first handle and rotatably mounted on the connecting member, the core tube passing through the connecting member and fixedly connected to the second handle;

[0009] A rotation locking mechanism, for limiting or allowing the second handle to rotate circumferentially relative to the first handle, the rotation locking mechanism comprising:

[0010] a limiting portion, provided on the connecting member;

[0011] A locking member is movably arranged inside the second handle and limited in rotation with the second handle along the circumferential direction. The locking member and the limiting portion have a locked state that is combined with each other and an unlocked state that is separated from each other. In the unlocked state, the second handle is allowed to rotate relative to the connecting member. An operating hole is provided on the outer surface of the second handle for a force-applying member to extend into the second handle to push the locking member toward the unlocked state.

[0012] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution. They are merely further supplements or optimizations. Under the premise that there are no technical or logical contradictions, each optional method can be combined separately for the above-mentioned overall solution, or multiple optional methods can be combined.

[0013] Optionally, the second handle includes two shells that are locked with each other, one of the shells is provided with the operating hole, and the locking piece is radially aligned with the operating hole.

[0014] Optionally, the area of ​​the operation hole is less than or equal to 10 square millimeters.

[0015] Optionally, the rotation locking mechanism further includes:

[0016] The second elastic member acts between the second handle and the locking member to drive the locking member and the limiting portion into a locked state. The operating hole and the second elastic member are located on two opposite sides of the locking member.

[0017] Optionally, the locking member is annular and is disposed around the limiting portion, and the locking member has an inner side facing the limiting portion and an outer side opposite thereto;

[0018] The limiting portion is a groove or a protrusion, and the inner side of the locking member has a clamping portion that matches the shape of the limiting portion.

[0019] Optionally, a radially extending sliding groove is provided inside the second handle, and the locking member moves along the sliding groove to switch between a locked state and an unlocked state.

[0020] Optionally, a fixing sleeve is provided on the outer periphery of the connecting member, the fixing sleeve protrudes radially outward relative to the connecting member and is partially inserted into the sliding groove, and the fixing sleeve is axially restricted by the groove wall of the sliding groove to maintain the axial relative position of the second handle and the connecting member.

[0021] Optionally, the first handle has a proximal end portion fixedly disposed with the support body, and the sliding locking mechanism includes:

[0022] a first positioning groove, arranged around the outer circumference of the proximal portion;

[0023] a first limiting member, radially slidably installed in the second handle, the first limiting member being annular and having a rib on the inner edge; when the sliding locking mechanism is locked, the first limiting member is sleeved on the outer periphery of the first positioning groove, and the rib extends into the first positioning groove;

[0024] a first unlocking button, movably embedded in the second handle, and linked with the first limiting member to drive the first limiting member to disengage from the first positioning groove;

[0025] The first elastic member acts between the second handle and the first limiting member to drive the first limiting member into the first positioning groove. The first unlocking button and the first elastic member are located on two opposite sides of the first limiting member in a radial direction.

[0026] Optionally, the support body is provided with a guide hole for the connecting member to extend through, and an interacting circumferential limiting structure is provided between the inner wall of the guide hole and the outer wall of the connecting member.

[0027] Optionally, the circumferential limiting structure includes:

[0028] a guide groove, provided on the inner wall of the guide hole;

[0029] The guide rail is arranged on the outer wall of the connecting member, and the guide rail is placed in the guide groove and extends axially.

[0030] The hidden trigger-type interventional delivery system of the present application improves the structure of the control handle, and the trigger components of some functions are hidden, which can avoid unexpected misoperations and improve the fault tolerance performance of the system. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the conventional technology, the following briefly introduces the drawings required for use in the embodiments or the conventional technology descriptions. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0032] Figure 1 This is a structural diagram of an interventional delivery system in one embodiment of the present application;

[0033] Figure 2 for Figure 1 A schematic structural diagram of a control handle in an interventional delivery system (the first shielding cover is in a separated state);

[0034] Figure 3 for Figure 1 A schematic structural diagram of a control handle in an interventional delivery system (the first shielding cover is in a flipped state);

[0035] Figure 4 for Figure 2 An exploded diagram of the distal end of the control handle;

[0036] Figure 5 for Figure 4 A further decomposition diagram of the relevant components;

[0037] Figure 6 for Figure 1 A schematic structural diagram of a catheter assembly in an interventional delivery system;

[0038] Figure 7 for Figure 6 A cross-sectional view of the middle tube assembly at the control handle;

[0039] Figure 8 for Figure 7 An enlarged view of the middle pipe joint;

[0040] Figure 9 for Figure 7 An enlarged view of another pipe joint and related parts on its proximal side;

[0041] Figure 10 for Figure 1 A cross-sectional view of a control handle in an interventional delivery system;

[0042] Figure 11 This is a structural diagram of an interventional delivery system (the second shielding cover is in the initial position) in one embodiment of the present application;

[0043] Figure 12 for Figure 11 A schematic diagram of the structure after the second shielding cover is flipped open;

[0044] Figure 13 This is a schematic diagram of an interventional delivery system according to an embodiment of the present application, in which the first handle and the second handle are in a combined state, and the outer sheath is in a first state;

[0045] Figure 14 for Figure 13 Schematic diagram of the middle and outer sheaths moving proximally to the third state;

[0046] Figure 15 for Figure 14 A schematic diagram showing a state in which the second handle moves proximally relative to the first handle so that the first handle and the second handle are separated and the distal end of the outer sheath is closed;

[0047] Figure 16 A schematic structural diagram of an interventional delivery system (partially shown with the second handle exploded) in one embodiment of the present application;

[0048] Figure 17 for Figure 16 A further exploded schematic diagram of the sliding locking mechanism;

[0049] Figure 18 for Figure 17 A schematic diagram of the second handle and related components after they move proximally relative to the first handle;

[0050] Figure 19 Figure 18 An enlarged view of the middle rotation locking mechanism;

[0051] Figure 20 Schematic diagram of the exploded view of the connector and related components;

[0052] Figure 21 for Figure 20 An enlarged view of the central axial limiting structure and related components;

[0053] Figure 22 for Figure 20 An exploded view of the middle connector and the rotation locking mechanism from another angle;

[0054] Figure 23 This is a flow chart of a method for deploying an artificial implant in one embodiment of the present application;

[0055] Figure 24 This is a schematic diagram of an artificial implant deployed in a pulmonary artery in one embodiment of the present application;

[0056] Figure 25 for Figure 24 A schematic diagram of an artificial pulmonary valve in an embodiment of the present invention;

[0057] Figure 26 This is a schematic diagram of an artificial implant deployed in the aorta before circumferential registration in one embodiment of the present application;

[0058] Figure 27 for Figure 26 Schematic diagram of the circumferential position relationship between the artificial implant and the native tissue;

[0059] Figure 28 for Figure 26 Schematic diagram of the artificial implant after circumferential registration and completion of release;

[0060] Figure 29 for Figure 28 Schematic diagram of the circumferential position relationship between the artificial implant and the native tissue;

[0061] Figure 30 This is a schematic diagram of an artificial implant deployed in the aorta in one embodiment of the present application;

[0062] Figure 31 FIG1 is a schematic diagram of an artificial implant deployed in the aorta according to an embodiment of the present application.

[0063] The reference numerals of the components are as follows:

[0064] 100. First handle; 110. Support body; 111. Tubular portion; 112. Avoidance opening; 113. Outward-turning portion; 114. Slot; 115. Guide groove; 116. Guide hole; 117. Guide groove; 118. Proximal portion; 119. First positioning groove; 120. Housing; 121. Operation opening; 130. First shielding cover; 131. Hinge mounting side; 132. Free-turning side; 133. Force-applying portion; 134. Buckle; 135. Side; 136. Rib; 140. Drive sleeve; 150. Connector; 151. Guide rail; 152. Limiting groove; 153. Fixing sleeve; 154. Groove; 160. End cap; 170. Limiting pin; 171. Ring portion; 172. Unlocking portion; 173. Third elastic member;

[0065] 200, second handle; 210, housing; 211, operating hole; 220, first limiting member; 221, rib; 230, first unlocking button; 240, first elastic member; 250, locking member; 251, engaging portion; 260, second elastic member; 270, sliding groove; 280, mounting groove;

[0066] 300, catheter assembly; 310, core tube; 311, guide head; 312, tailstock; 313, mounting head; 320, outer sheath; 321, first pipe connector; 322, loading section; 323, barrel; 324, sliding seat; 330, sheath; 331, second pipe connector; 332, interface; 333, one-way valve core; 334, sealing ring; 335, distal port; 336, proximal port;

[0067] 340, inner sheath; 341, handle; 342, tube body; 343, second shielding cover; 344, third tube connector; 345, external tube;

[0068] 400, artificial implant; 410, stent; 411, connecting ear; 420, leaflet; 421, commissure;

[0069] 500. Heart; 510. Right atrium; 520. Right ventricle; 530. Main pulmonary artery; 540. Right pulmonary artery; 550. Left pulmonary artery; 560. Aorta; 561. Native valve leaflets; 562. Valvular sinuses; 563. Coronary artery ostia. DETAILED DESCRIPTION

[0070] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0071] It should be noted that when a component is referred to as being "fixed to" or "disposed on" another component, it may be directly on the other component or there may be a central component. When a component is considered to be "connected to" another component, it may be directly connected to the other component or there may be a central component at the same time. The terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in the specification of this application are for illustrative purposes only and do not represent the only implementation method.

[0072] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of such features. Throughout the description of this application, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0073] In this application, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it can mean that the first feature is directly in contact with the second feature, or the first feature and the second feature are indirectly in contact through an intermediary. Furthermore, when a first feature is "above," "above," or "above" a second feature, it can mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is higher in level (or in a state of use, or from a certain perspective in the drawings) than the second feature. When a first feature is "below," "below," or "below" a second feature, it can mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is lower in level (or in a state of use, or from a certain perspective in the drawings) than the second feature.

[0074] When used to indicate direction, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the side relatively farther away. Along the interventional pathway, each component has relative distal and proximal ends. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text indicates the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0075] Unless otherwise defined, all technical and scientific terms used in the specification of this application have the same meaning as commonly understood by those skilled in the art to which this application belongs. The terms used in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used in the specification of this application includes any and all combinations of one or more of the relevant listed items.

[0076] This specification describes certain artificial implants and interventional delivery systems for interventional delivery of artificial implants. The interventional delivery system includes a control handle and a catheter assembly. The catheter assembly includes multiple control components. The distal ends of each control component cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking its position, adjusting its spatial posture, etc. Each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of these. There are multiple control components, and at least two (for example, the proximal end) can slide relative to each other along the axial direction or rotate relative to each other about the axial direction. The force-applying member (the part that the user directly contacts) on the control handle used to operate each control component can be directly fixedly connected to the corresponding control component, or can be driven by threads, rack and pinion, or other means.

[0077] There are no strict restrictions on the application site and structure of artificial implants. For example, artificial implants can include replacement and repair devices for treating heart valve diseases, as well as vascular stents. In some drawings or texts, artificial implants take artificial heart valves as an example. Artificial heart valves generally include a deformable stent and leaflets connected to the stent. The stent is cylindrical in shape as a whole, and the sidewalls are hollow grid structures. Unless otherwise stated, the shape or size of the grid structure is not strictly limited. The interior of the stent is a blood flow channel, and the multiple leaflets cooperate with each other to control the degree of opening and closing of the blood flow channel in the stent. For positioning in the body, positioning structures that can interact with the surrounding native tissues, such as anchor spikes, arms, etc., can be set on the periphery of the stent. In order to prevent peripheral leakage, skirts or anti-peripheral leakage materials can be set on the inner and / or outer sides of the stent.

[0078] Depending on the release mode, the stent is processed using corresponding materials, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that is released by balloon expansion, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

[0079] Taking a self-expanding stent as an example, its release and recovery can be controlled by an outer sheath wrapped around the stent. This can be controlled by varying the location of the stent exposed to the outer tube. Alternatively, a pull wire can be used for control. The pull wire passes through the structural gap (or wire hole structure) of the stent. The expansion degree of the stent can be changed by adjusting the tension of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be fully released. Of course, the control of the pull wire is also accomplished through the various controlled components in the catheter assembly.

[0080] The stent of an artificial implant may generally have a connection structure that cooperates with the catheter assembly to limit the position of each other and prevent unnecessary positional displacement during delivery. The artificial implant is in a radially compressed state, i.e., a loaded state, when introduced. After being freed from the constraints of the catheter assembly and radially expanded in the body, it is in a released state. Unless otherwise specified, the shape of the artificial implant is understood to be in the released state, and the local deformation caused by the pressure of the surrounding tissue is not taken into account.

[0081] Due to the complexity of the structure in the body, catheter components often need to be bent. The corresponding bending parts can be in the form of tubes or wires, with the distal end acting on the bent part and the proximal end operating the bending amplitude or direction through a control handle.

[0082] See also Figure 1 One embodiment of the present application provides an interventional delivery system having relative distal and proximal ends and an axial direction extending between the distal and proximal ends. The proximal end in this application generally refers to the side adjacent to the operator (e.g., doctor), and the distal end is the side relatively far away. Along the interventional path, each component has relative distal and proximal ends. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction of the interventional delivery system. The X direction in the figure is from the proximal end to the distal end, and correspondingly, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction (direction C in the figure) are also determined. Unless otherwise specified in this application, the axial, radial, and circumferential directions are all understood as the orientation of the interventional delivery system. When used to refer to a structure, the "end" in this application refers to the end point of the structure or a point or area in the lateral direction or a specific structure connected to the point or area.

[0083] This embodiment provides an interventional delivery system having a distal end and a proximal end opposite to each other and an axial direction extending between the distal end and the proximal end. The interventional delivery system includes:

[0084] A control handle, wherein the interior of the control handle has an installation chamber, and the surface of the control handle is provided with an operating port 121 communicating with the installation chamber;

[0085] A first shielding cover 130 movably connected to the control handle to close or open the operating port 121;

[0086] The catheter assembly 300 includes at least one pipe, the proximal end of which extends into the installation chamber. The proximal end of the pipe is provided with a pipe joint located in the installation chamber, and the position of the pipe joint is exposed to the operation port 121.

[0087] The control handle may include a first handle 100 and a second handle 200, which are in a relative combination state (eg Figure 1 As shown), the second handle 200 can also slide proximally relative to the first handle 100, that is, the two can enter a separated state to achieve corresponding functions. Of course, the first handle 100 and the second handle 200 can also adopt an integral structure, that is, the two are positioned and matched along the axial direction.

[0088] Combine Figure 2~Figure 3 In this embodiment, the interior of the control handle is an installation chamber, and the proximal end of the catheter assembly 300 extends into the interior of the control handle. In addition, part of the structure for connecting or driving the catheter assembly 300 is also located in the installation chamber. In this embodiment, an operation port 121 communicating with the installation chamber is opened on the surface of the control handle. For example, a part of the control handle is provided with a shell 120, and the operation port 121 is opened in the shell 120. A first shielding cover 130 is provided at the operation port 121, and the first shielding cover 130 is movably connected to the control handle to close or open the operation port 121.

[0089] In this embodiment, by providing an operating port 121 and a matching first shielding cover 130, the internal structure of the control handle can be exposed when the first shielding cover 130 is opened, which facilitates operations such as exhausting the inside of the handle, disassembly and assembly, replacement of components, observation of status, or connection of external devices. It can also quickly handle abnormalities when they occur to ensure smooth operation. After the first shielding cover 130 closes the operating port 121, the appearance of the control handle is relatively neat, which avoids pipeline entanglement and facilitates packaging.

[0090] In one embodiment, the catheter assembly 300 includes at least one pipe, the proximal end of which extends into the installation chamber. The proximal end of the pipe is provided with a pipe connector located within the installation chamber, and the position of the pipe connector is at least exposed to the operation port 121. The pipe connector can be used to connect external pipes, pumps, valves, and other devices, for example, to implement perfusion, sampling, preoperative exhaust, etc. In the prior art, to achieve related functions, the outside of the control handle is generally provided with an extension tube. One end of the extension tube extends into the installation chamber and connects to the corresponding pipe, and the other end of the extension tube is redundant on the outside of the control handle. On the one hand, this affects the neat appearance. On the other hand, multiple extension tubes may interfere with each other and with external devices, which is not conducive to operation.

[0091] The first shielding cover 130 is detachably connected to the control handle. When the operating port 121 needs to be opened, the first shielding cover 130 is directly removed, or the first shielding cover 130 is rotated or slidably connected to the control handle. When the operating port 121 needs to be opened, the posture of the first shielding cover 130 is adjusted to open the operating port 121.

[0092] Taking the rotational connection as an example, the proximal end of the first shielding cover 130 is a hinged mounting side 131, and the distal end is a free-flip side 132. To facilitate operation, the free-flip side 132 has a force-applying portion 133 that protrudes from the outer surface of the control handle. When the first shielding cover 130 closes the operating port 121, the force-applying portion 133 protrudes or tilts relative to the outer surface of the control handle to facilitate gripping and applying force. Except for the force-applying portion 133, the remaining portions of the first shielding cover 130 are flush with or smoothly transition from the outer surface of the adjacent portions of the control handle.

[0093] In some preferred embodiments, the first shielding cover 130 is sealed with the operating port 121. For example, at least a portion of the first shielding cover 130 can extend into the operating port 121 and be sealed with the inner edge of the operating port 121. The first shielding cover 130 can use elastic materials or sealing rings at the sealing portion to maintain sealing.

[0094] After the first shielding cover 130 closes the operating port 121, in order to maintain the current state and avoid unexpected dislocation or falling off, an anti-falloff structure can be set between the first shielding cover 130 and the control handle. For example, the free flip side 132 has a buckle 134 that cooperates with the control handle. The buckle 134 maintains the position of the first shielding cover 130 through its own elastic deformation, tensioning with the inner edge of the operating port 121, or extending into the corresponding slot.

[0095] To further limit the position and ensure a sealed effect, the first shielding cover 130 is provided with a side edge 135 extending into the interior of the operating port 121. A positioning structure is provided between the side edge 135 and the control handle. For example, a slot 114 is provided in the control handle, and a rib 136 is provided on the side edge 135 to fit into the slot 114.

[0096] The catheter assembly 300 includes at least two pipe fittings arranged inner and outer. Among the two adjacent pipe fittings, one is the outer tube and the other is the inner tube, and there is a radial gap between the two. The proximal end of the outer tube is provided with a pipe joint, which is slidably and sealedly sleeved on the outside of the inner tube. The pipe joint has an interface for connecting external devices, and the interface is connected to the radial gap between the outer tube and the inner tube.

[0097] Combine Figures 4 to 7 In one embodiment, the catheter assembly 300 includes a plurality of pipes, each of which is connected to the control handle using one of the following connection methods:

[0098] fixed connection; or

[0099] Axially sliding and circumferentially limited connection; or

[0100] Connected in axial sliding and circumferential rotation.

[0101] For example, the plurality of tubes include a core tube 310 and an outer sheath tube 320 which are sequentially mounted from the inside to the outside. The distal end of the core tube 310 is used to load the artificial implant. The outer sheath tube 320 can at least slide with respect to the core tube 310 to wrap, restrain or expose the artificial implant.

[0102] In other embodiments, the catheter assembly 300 further includes a sheath 330 located around the outer sheath 320, wherein the core tube 310 and the outer sheath 320 can be arranged to be controlled relative to the control handle, and the proximal end of the sheath 330 can be fixed to the control handle through the end cap 160.

[0103] The proximal end of the outer sheath tube 320 is provided with a first pipe joint 321, and the core tube 310 extends out of the proximal end of the outer sheath tube 320 through the first pipe joint 321 inside the outer sheath tube 320. A movable seal can be adopted between the outer wall of the core tube 310 and the first pipe joint 321, that is, the outer sheath tube 320 and the core tube 310 are allowed to move relative to each other, and the outer wall of the core tube 310 and the first pipe joint 321 remain sealed during movement. The radial gap between the interface of the first pipe joint 321 connecting the outer sheath tube 320 and the core tube 310 can be used to implement operations such as perfusion and exhaust.

[0104] Since the outer sheath 320 slides axially relative to the control handle, the operating port 121 is strip-shaped and its length adapts to the stroke of the pipe to avoid interfering with the movement of the first pipe connector 321 .

[0105] A second pipe connector 331 is provided at the proximal end of the sheath 330, and the outer sheath tube 320 extends out of the proximal end of the sheath 330 through the second pipe connector 331 inside the sheath 330. A movable seal can be adopted between the outer wall of the outer sheath tube 320 and the second pipe connector 331, that is, the outer sheath tube 320 and the sheath 330 are allowed to move relative to each other, and the outer wall of the outer sheath tube 320 and the second pipe connector 331 remain sealed during movement. The radial gap between the interface of the second pipe connector 331 connecting the outer sheath tube 320 and the sheath 330 can be used to implement operations such as perfusion and exhaust.

[0106] The control handle (taking the first handle 100 as an example in the figure) includes a support body 110 and a shell 120 surrounding at least a portion of the support body 110. One portion of the support body 110 is a tubular portion 111. The proximal end of the outer sheath 320 is located in the tubular portion 111. The side wall of the tubular portion 111 is provided with an avoidance opening 112. When multiple pipe joints are configured, at least one pipe joint is located in the avoidance opening 112, and other pipe joints may also be located outside the avoidance opening 112.

[0107] In this embodiment, the avoidance opening 112 is used to expose the first pipe connector 321 and avoid the movement of the first pipe connector 321. The edge of the avoidance opening 112 is provided with an outward-turned portion 113, and the card slot 114 is provided on the outward-turned portion 113. The second pipe connector 331 is located on the distal side of the tubular portion 111. The outer shell 120 is located on the outer periphery of the tubular portion 111, and the operation port 121 is opened on the outer shell 120.

[0108] See also Figure 8 The second pipe connector 331 can adopt the same structure as the first pipe connector 321. Taking the second pipe connector 331 as an example, the second pipe connector 331 is a three-way structure as a whole, including a body with a distal port 335 and a proximal port 336. The distal port 335 and the proximal port 336 are arranged opposite to each other along the axial direction for pipes to pass through. The interface 332 is located on one side of the radial direction of the body for exhaust or for connecting external devices. For example, when used for exhaust, a one-way valve core 333 is provided inside the second pipe connector 331, which only allows the fluid to flow from the interface 332 to the radial gap between the outer sheath 320 and the sheath 330.

[0109] The sheath 330 as an outer tube is fixedly inserted into the body through the distal port 335 , and the outer sheath tube 320 as an inner tube extends out of the body through the proximal port 336 and is slidably sealed with the outer wall of the outer sheath tube 320 through a sealing ring 334 .

[0110] See also Figure 9 and Figure 10 In order to drive the outer sheath 320 to slide axially and limit circumferentially relative to the first handle 100, the support body 110 is provided with a guide groove 115 extending axially. The first pipe connector 321 is further connected to a transmission member extending toward the proximal end. The transmission member is slidably disposed in the guide groove 115. For example, the transmission member includes:

[0111] The barrel 323 is located on the outer periphery of the core tube 310 and extends from the first pipe connector 321 toward the proximal end;

[0112] The sliding seat 324 is fixed to the cylinder 323 and provides transmission teeth. The sliding seat 324 slides along the guide groove 115 and is restricted from rotating.

[0113] The control handle further includes a drive sleeve 140 rotatably sleeved on the outside of the support body 110 . The drive sleeve 140 has an internal thread and is threadedly engaged with the transmission gear.

[0114] See also Figure 11 One embodiment of the present application also provides another interventional delivery system. This embodiment differs from the previous embodiments primarily in that the catheter assembly 300 further includes an inner sheath 340, located at the outermost layer of the catheter assembly. The inner sheath 340 is slidably mounted on the outer periphery of the outer sheath 320. The figure also illustrates an artificial implant 400 encased and loaded within the outer sheath 320. The inner sheath 340 includes a handle 341 and a tubular body 342 extending distally from the handle 341. The handle 341 and tubular body 342 communicate with each other through a through-hole for the outer sheath 320 to pass through. To expel air from the gap between the tubular body 342 and the outer sheath 320 prior to surgery, a third pipeline connector 344 (e.g., a Luer connector) is provided on the handle 341 and communicates with the through-hole. The handle 341 is also provided with a second shielding cap 343. Prior to use, the second shielding cap 343 covers the third pipeline connector 344.

[0115] The outer periphery of the handle 341 has a sedimentation area, the third pipe joint 344 is located in the sedimentation area, and the second shielding cover 343 is covered in the sedimentation area. The second shielding cover 343 can be installed in a sliding or rotating manner. When the second shielding cover 343 covers the third pipe joint 344, it smoothly transitions to the surrounding area of ​​the handle 341 or is flush with each other in height, which can avoid excessive protrusion of the part and keep the exterior neat and beautiful.

[0116] See also Figure 12 When in use, flip or remove the second shielding cover 343 to expose the third pipe connector 344, and then connect the external pipe 345 (such as a syringe) to the third pipe connector 344. In this embodiment, the first handle 100 has a first shielding cover 130, and the handle 341 of the inner sheath 340 is provided with a second shielding cover 343, which can make the product appearance more neat and convenient to operate when the external pipe is connected.

[0117] In order to solve the problem of misalignment of the circumferential release position of the implant during the implantation process, or the problem that the implant cannot be smoothly separated from the delivery system due to differences in the physiological structure of the human body's lesion location during the implant release process, the present application also provides a rotation locking mechanism for controlling the rotation of the catheter to ensure the smooth progress of the operation.

[0118] The present application also provides a rotation locking mechanism for controlling the rotation of a catheter. The rotation locking mechanism can be applied to the delivery system described in any of the above embodiments to limit or allow the rotation of the core tube.

[0119] See also Figures 13 to 22The present application also provides a hidden trigger-type interventional delivery system having a distal end and a proximal end relative to each other and an axial direction extending between the distal end and the proximal end, the interventional delivery system comprising:

[0120] The catheter assembly 300 includes a core tube 310 and an outer sheath tube 320 located on the outer periphery of the core tube 310;

[0121] The first handle 100 includes a support body 110 and a connector 150 that is axially slidable and circumferentially limited and is mounted on the support body 110 . The proximal end of the outer sheath 320 is slidably connected to the support body 110 .

[0122] The second handle 200 is located at the proximal end of the first handle 100 and is rotatably mounted on the connecting member 150. The core tube 310 passes through the connecting member 150 and is fixedly connected to the second handle 200.

[0123] The rotation locking mechanism is used to limit or allow the second handle 200 to rotate circumferentially relative to the first handle 100. The rotation locking mechanism includes:

[0124] A limiting portion, provided on the connecting member 150;

[0125] The locking member 250 is movably arranged inside the second handle 200 and is limited in rotation with the second handle 200 along the circumferential direction. The locking member 250 and the limiting portion have a locked state in which they are combined with each other and an unlocked state in which they are separated from each other. In the unlocked state, the second handle 200 is allowed to rotate relative to the connecting member 150. An operating hole 211 is provided on the outer surface of the second handle 200 for a force-applying member to extend into the second handle 200 to push the locking member 250 toward the unlocked state.

[0126] A guidewire channel can be provided inside the core tube 310, and a mounting head 313 can be fixed to the core tube 310. When the artificial implant 400 is loaded, it can be connected to the mounting head 313 in a controllable and releasable manner by means of snapping, hanging, etc. In addition, the core tube 310 can also be a balloon catheter, and a balloon body is provided at the distal end of the core tube. When the artificial implant 400 is loaded, it can be compressed around the balloon body and released through the inflatable balloon body.

[0127] In this embodiment, the core tube 310 for carrying the artificial implant 400 can be rotated relative to the first handle 100. When the artificial implant 400 is transferred, the relative angle between the artificial implant 400 and the first handle 100 can be pre-aligned to facilitate positioning in the body; the posture of the artificial implant 400 in the body can be adjusted before it is released to facilitate adaptation to the physiological structure; after the artificial implant 400 is released, when the distal end of the core tube 310 is blocked from retraction, the core tube 310 can be rotated in time to eliminate obstruction and interference, thereby facilitating the rapid withdrawal of the interventional delivery system out of the body.

[0128] The catheter assembly 300 can also include an outer sheath tube 320 located on the periphery of the core tube 310. The artificial implant 400 can be loaded into the radial gap between the core tube 310 and the outer sheath tube 320. The outer sheath tube 320 and the core tube 310 are slidably matched. During interventional delivery, the outer sheath tube 320 wraps the artificial implant 400. When release is required, the outer sheath tube 320 and the core tube 310 slide relative to each other to expose the artificial implant 400.

[0129] Regarding the axial movement cooperation relationship among the first handle 100 , the outer sheath tube 320 and the core tube 310 , at least one of them can move axially relative to the other two, or any one of them can move axially relative to the other two.

[0130] In this embodiment, the proximal end of the outer sheath 320 is mounted on the first handle 100 and slides axially relative to the first handle 100. The proximal end of the core tube 310 is mounted on the second handle 200 and can slide axially relative to the first handle 100 along with the second handle 200. Based on this, the delivery system of this embodiment also provides a sliding locking mechanism for limiting or allowing the core tube 310 to slide axially relative to the first handle 100.

[0131] A connecting piece 150 is installed in the first handle 100 so as to slide axially and be circumferentially limited. The second handle 200 is installed on the connecting piece 150. The connecting piece 150 and the second handle 200 can slide axially relative to the first handle 100. A tail stock 312 is fixed to the proximal end of the core tube 310 and is fixedly connected to the second handle 200 through the tail stock 312.

[0132] Delivery of artificial implants: see Figure 13 When the artificial implant 400 is delivered in the body, the guide head 311 at the distal end of the core tube 310 closes the distal port of the outer sheath tube 320, that is, the outer sheath tube 320 is in the first state, and the artificial implant 400 is loaded in the radial gap between the core tube 310 and the outer sheath tube 320. At this time, the first handle 100 and the second handle 200 are in a combined state, and the sliding locking mechanism is correspondingly in a locked state.

[0133] Release of artificial implant: When the artificial implant is delivered to the designated position and aligned with the surrounding tissue, during the release and deployment process of the artificial implant 400, the outer sheath 320 moves proximally relative to the first handle 100, i.e., slides proximally relative to the core tube 310 and gradually exposes the artificial implant 400. At this time, the outer sheath 320 is in the second state, the first handle 100 and the second handle 200 are in a combined state, and the sliding locking mechanism is correspondingly in a locked state. After the artificial implant 400 is fully deployed or released from the delivery system, the outer sheath 320 is in the third state of sliding to the maximum stroke, such as Figure 14As shown, the core tube 310 at the distal end of the catheter assembly 300 is further extended distally relative to the outer sheath 320, and a mounting head 313 is fixed on the core tube 310. The artificial implant 400 includes a stent 410 and a leaflet 420. The proximal side of the stent 410 is provided with a connecting ear 411. During the interventional delivery process, the connecting ear 411 and the mounting head 313 are connected to each other (for example, by complementary shape engagement or thread binding) and maintain relative positions. When the artificial implant 400 is released, the connecting ear 411 and the mounting head 313 are disengaged from each other, allowing the artificial implant 400 to detach from the catheter assembly 300.

[0134] Recovery of the interventional delivery system: When the catheter assembly 300 is withdrawn outside the body, the proximal end of the guide head 311 needs to be closed with the distal end port of the outer sheath tube 320, and then the catheter assembly 300 is withdrawn outside the body. In order to save surgical time, the sliding locking mechanism is unlocked, allowing the core tube 310 to slide proximally to quickly close the distal end of the outer sheath tube 320. The sliding of the core tube 310 proximally relative to the outer sheath tube 320 is driven by the second handle 200, that is, the second handle 200 moves proximally relative to the first handle 100 until Figure 15 As shown, the guide head 311 at the distal end of the core tube 310 closes the distal port of the outer sheath tube 320 (at this time, observing the relative positions of the core tube 310 and the outer sheath tube 320 separately can also be regarded as the outer sheath tube 320 entering the first state of being closed at the distal end again), and then the catheter assembly 300 is withdrawn from the body together. During this process, the first handle 100 and the second handle 200 are in a separated state.

[0135] Before or during the process of the core tube 310 sliding proximally relative to the outer sheath tube 320 , the rotation locking mechanism can be unlocked as needed to allow the core tube 310 to rotate, so as to avoid interference with surrounding tissues or artificial implants and ensure smooth operation.

[0136] For the setting of the slide lock mechanism, see Figures 16 to 18 The first handle 100 and the second handle 200 have a relative combined state and a separated state. When implementing interventional delivery, the first handle 100 and the second handle 200 are in the combined state, and the guide head 311 at the distal end of the core tube 310 approaches and closes the loading section 322 of the outer sheath tube. When it is necessary to release the artificial implant 400, the outer sheath tube 320 is slid proximally relative to the first handle 100 and the core tube 310 to expose the artificial implant 400. After the artificial implant 400 is completely exposed and released, the first handle 100 and the second handle 200 are still in the combined state, but the guide head 311 and the distal end of the loading section 322 have been separated by a distance, as shown in FIG. Figure 16 shown.

[0137] After that, the catheter assembly 300 needs to be withdrawn from the body. First, the sliding locking mechanism is unlocked, and then the second handle 200 is driven to slide proximally relative to the first handle 100 into a separated state. Figure 18 As shown, the guide head 311 at the distal end of the core tube 310 will follow the movement and gradually approach and close the loading section 322 of the outer sheath tube 320. Compared with the thread-driven outer sheath tube 320 moving toward the distal end, the core tube 310 in this application can be quickly retracted along with the second handle 200, and after closing the distal end of the loading section 322, it can be withdrawn out of the body together with the outer sheath tube 320.

[0138] In the sliding locking mechanism, the proximal portion 118 of the first handle 100 is provided with a first positioning groove 119, and a first stopper 220 is movably mounted on the second handle 200 and engages with the first positioning groove 119. The proximal portion 118 is fixedly disposed relative to the support body 110. For example, it can be provided by the support body 110, or a housing can be fixed to the outer periphery of the support body 110 and the proximal portion 118 is provided by the housing. The proximal portion 118 of the first handle 100 is a tubular structure, and the first positioning groove 119 is distributed around the outer periphery of the proximal portion 118.

[0139] The first limiting member 220 can be radially slidably installed in the second handle 200. When the first limiting member 220 is inserted into the first positioning groove 119, the first handle 100 and the second handle 200 can be kept in a combined state. When the first limiting member 220 is disengaged from the first positioning groove 119, the second handle 200 is allowed to slide toward the proximal end.

[0140] The first limiting member 220 is annular. In the engaged state, the first limiting member 220 is sleeved on the outer circumference of the first positioning groove 119. In the sliding locking mechanism, the first limiting member 220 and the first positioning groove 119 are both annular, and the locking state is changed only during radial relative movement. This design allows the first limiting member 220 and the first positioning groove 119 to rotate relative to each other regardless of whether they are engaged or disengaged, that is, the state of the sliding locking mechanism does not affect the rotation of the second handle 200 relative to the first handle 100.

[0141] The first retaining member 220 has a rib 221 on its inner edge, which can extend into the first positioning slot 119 to achieve axial locking. One of the two opposing sides of the first retaining member 220 has a first unlocking button 230, while the other side abuts a first elastic member 240. The first elastic member 240 acts between the second handle 200 and the first retaining member 220 to drive the first retaining member 220 into the first positioning slot 119. The first unlocking button 230 is movably mounted on the second handle 200. When the first unlocking button 230 is pressed, it interacts with the first retaining member 220 to drive the first retaining member 220 out of the first positioning slot 119.

[0142] The first limiting member 220, the first unlocking button 230 and the first elastic member 240 form a set of mechanisms. In the embodiment shown in the figure, two sets are provided, and the first unlocking buttons 230 in the two sets are arranged relative to each other. One end of each first elastic member 240 abuts against the first limiting member 220 belonging to the same set, and the other end abuts against the first unlocking button 230 in the other set. The radial arrangement of the two sets of mechanisms can take into account both locking stability and convenient operation. The first limiting members 220 in the two sets of mechanisms are stacked axially, and the first positioning grooves 119 are correspondingly configured with two.

[0143] For the setting of the rotation locking mechanism, see Figures 16 to 19 , wherein the first handle 100 includes a support body 110, the proximal end of the outer sheath 320 is slidably connected to the support body 110, for example, in threaded transmission cooperation with the drive sleeve 140, a connector 150 is installed in the support body 110 in an axially sliding and circumferentially limited manner, the second handle 200 is circumferentially connected to the connector 150, and the core tube 310 extends proximally through the connector 150 until it is fixedly connected to the second handle 200 through the tailstock 312. When the second handle 200 slides relative to the first handle 100, the connector 150 follows, and when the core tube 310 needs to be rotated, the second handle 200 rotates synchronously, but the connector 150 and the first handle 100 remain relatively fixed, so that the rotation locking mechanism can act between the connector 150 and the second handle 200.

[0144] The connector 150 connects the second handle 200 and the first handle 100 and also provides a channel or guide structure for the core tube 310 to extend. For example, the connector 150 is an axially extending strip-shaped member. The connector 150 can be tubular, with the core tube 310 extending through the interior of the connector 150. Alternatively, the outer wall of the connector 150 is provided with an axially extending receiving groove, through which the core tube 310 extends.

[0145] The connecting member 150 and the core tube 310 are axially positioned and circumferentially rotated together. The proximal end of the connecting member 150 extends into the interior of the second handle 200 and is axially positioned and circumferentially rotated together with the second handle 200, that is, it is indirectly axially positioned and circumferentially rotated together with the core tube 310 through the second handle 200.

[0146] The rotation locking mechanism specifically includes a locking member 250 movably mounted on the second handle 200 and a limiting portion provided on the connecting member 150. The locking member 250 and the limiting portion have a locked state in which they are engaged with each other, and a separated unlocked state. The locking member 250 can be slidably mounted to the second handle 200 in a radial or tangential direction and is rotationally limited relative to the second handle 200 in a circumferential direction. For example, a slide groove 270 is provided within the second handle 200, along which the locking member 250 moves to switch between the locked and unlocked states. Furthermore, a mounting groove 280 is provided within the second handle 200, and the proximal end of the core tube 310 is fixed within the mounting groove 280 via a tailstock 312.

[0147] The second handle 200 is installed on the connecting member 150, and the rotation locking mechanism acts between the connecting member 150 and the second handle 200, which can prevent the second handle 200 from being interfered with by the first handle 100 when rotating. That is, the state of the rotation locking mechanism does not affect the sliding of the second handle 200. Regardless of whether the locking member 250 and the limiting portion of the connecting member 150 are engaged or separated, it does not affect the second handle 200 and the connecting member 150 sliding toward the proximal end relative to the first handle 100.

[0148] In the locked state, the limit portion inhibits the locking member 250 from rotating in the circumferential direction, and indirectly limits the rotation of the second handle 200. In the unlocked state, the second handle 200 and the locking member 250 are allowed to rotate in the circumferential direction together with the core tube 310.

[0149] The limiting portion is a groove 154, which can be provided by the outer wall of the connector 150 itself, or a fixing sleeve 153 can be provided on the outside of the connector 150, and the groove 154 is located on the outer wall of the fixing sleeve 153. Of course, the fixing sleeve 153 can also be an integral structure with the connector 150, and the fixing sleeve 153 provides a larger radial space so that the groove 154 has the necessary depth to ensure the locking effect.

[0150] On the one hand, the slide groove 270 allows the locking member 250 to slide radially, while also limiting the rotation and axial sliding of the locking member 250. The fixing sleeve 153 protrudes radially outward relative to other parts of the connecting member 150 and is partially inserted into the slide groove 270, so that the connecting member 150 is axially restricted by the groove wall of the slide groove 270. Based on this, the axial relative position of the second handle 200 and the connecting member 150 can be maintained.

[0151] The locking piece 250 is annular and is arranged around the fixing sleeve 153. The locking piece 250 has an inner side facing the limiting portion. The inner side of the locking piece 250 has a snap-fit ​​portion 251 that matches the shape of the groove 154. A second elastic piece 260 acts between the second handle 200 and the locking piece 250, which can drive the locking piece 250 and the limiting portion into a locked state. The second elastic piece 260 acts on the outer side of the locking piece 250.

[0152] The annular locking member 250 can reduce spatial interference with other components, especially the catheter assembly 300, and also ensure its own structural strength, and facilitate the arrangement of functional areas at various circumferential positions or the coordinated transmission with other components.

[0153] One embodiment of the present application also has a concealed design for the unlocking setting of the rotation locking mechanism. During the operation, when there is interference between the distal guide head of the delivery system and the implant, or there is a deviation in the positioning of the implant and repositioning is required, the rotation locking mechanism can be unlocked to enable the core tube or the core tube to drive the implant to rotate circumferentially. The concealed design can effectively prevent misoperation.

[0154] See also Figure 18 , Figure 19 The locking member 250 is arranged inside the second handle 200. The second handle 200 includes two shells 210 that are interlocked. One of the shells 210 is provided with an operating hole 211 for a force-applying component (such as a slender push rod, etc.) to extend into the interior of the second handle 200 and apply force along direction A to drive the locking member 250 to unlock.

[0155] The operating hole 211 can be circular, elliptical, polygonal, etc., and the area of ​​the operating hole 211 is less than or equal to 25 square millimeters. For example, the area of ​​the operating hole 211 is less than or equal to 10 square millimeters, which can avoid false triggering. The operating hole 211 and the second elastic member 260 are respectively located on two opposite sides of the locking member 250, and can switch the state of the locking member 250 along their respective action directions.

[0156] See 20~ Figure 22 In order to further limit the relative movement between the connecting member 150 and the supporting body 110 , a circumferential limiting structure and an axial limiting structure are provided between the connecting member 150 and the supporting body 110 .

[0157] Regarding the circumferential limiting structure, the support body 110 is provided with a guide hole 116 for the connecting member 150 to extend through, the inner wall of the guide hole 116 is provided with a guide groove 117, the outer wall of the connecting member 150 is provided with a guide rail 151 extending axially, and the guide rail 151 slides along the guide groove 117, and the guide groove 117 can limit the rotation of the connecting member 150.

[0158] Regarding the axial limiting structure, when the connecting member 150 moves with the second handle 200 toward the separated state, the axial limiting structure acts between the first handle 100 and the connecting member 150 to limit the movement stroke of the connecting member 150. The axial limiting structure includes:

[0159] The limiting groove 152 is formed on the outer wall of the connecting member 150;

[0160] A limiting pin 170 is slidably mounted on the first handle 100;

[0161] The third elastic member 173 drives the limiting pin 170 to enter the limiting groove 152 .

[0162] The limiting pin 170 includes an annular portion 171 and an unlocking portion 172. The annular portion 171 is sleeved on the outside of the connecting member 150. At least a portion of the inner edge of the annular portion 171 can extend into the limiting groove 152. The unlocking portion 172 is connected to the annular portion 171 and is used to push the limiting pin 170 out of the limiting groove 152. The unlocking portion 172 and the third elastic member 173 are respectively located on two opposite sides of the annular portion 171. Figure 21 It can be seen that the end of the unlocking portion 172 is exposed at the proximal portion 118 . When the axial limit needs to be released, force is applied along the direction B to press the unlocking portion 172 , which can drive the annular portion 171 out of the limiting groove 152 .

[0163] See also Figure 23 Some embodiments of the present application further provide a method for deploying an artificial implant 400, which can utilize the interventional delivery system of each of the above embodiments. The deployment method can be implemented in vivo or in vitro on a simulated organ. The artificial implant 400 can be an artificial heart valve, such as an artificial aortic valve, an artificial pulmonary valve, an artificial mitral valve, or an artificial tricuspid valve. The deployment method specifically includes:

[0164] Step S100: delivering a catheter assembly to a predetermined area via a control handle. The catheter assembly includes a core tube and an outer sheath disposed around the core tube. The artificial implant is loaded in a radially compressed state within a radial gap between the core tube and the outer sheath. The proximal end of the catheter assembly is connected to and controlled by the control handle.

[0165] Step S200 , relatively sliding the core tube and the outer sheath tube to expose the artificial implant, radially expanding the artificial implant to deploy the artificial implant in a preset area;

[0166] Step S300, recovering the catheter assembly;

[0167] At least one of step S200 and step S300 further includes rotating the core tube relative to the outer sheath tube, and the artificial implant and the core tube rotate synchronously or the core tube rotates independently relative to the artificial implant until it rotates to a desired position.

[0168] The deployment method can be implemented based on the interventional delivery system of each embodiment above. There is no strict limitation on the specific expansion method of the artificial implant after exposure. For example, self-expansion or balloon expansion can be used.

[0169] Figure 24 Taking an artificial pulmonary valve as an example, the heart 500 in the figure can be either a human organ or an artificial simulated organ outside the body. The deployment method of the artificial implant 400 in this embodiment includes:

[0170] An interventional route for delivering an artificial implant is preset, and an artificial implant 400 and an interventional delivery system are provided. The artificial implant 400 is an artificial pulmonary valve, which has relative expanded and folded states. During delivery, the artificial implant 400 is maintained in a radially compressed folded state, and after delivery to a predetermined location and deployment, it radially expands to an expanded state. The interventional delivery system may adopt the above embodiments, and may include, for example:

[0171] A catheter assembly, the catheter assembly at least comprising a core tube, the artificial implant 400 being connected to the distal end of the core tube;

[0172] The proximal end of the core tube is connected to the control handle, and a rotation locking mechanism is provided on the control handle for limiting or allowing the rotation of the core tube.

[0173] The catheter assembly is operated by a control handle to deliver the artificial pulmonary valve to the predetermined position along the interventional path, i.e., the native valve of the human body, and radially expand the artificial pulmonary valve to complete the deployment. The artificial pulmonary valve includes a stent and a valve and skirt located inside the stent. The stent adopts the valve stent described in patent document US20180049871A1. The overall structure of the corresponding artificial pulmonary valve can be found in Figure 25 .

[0174] The pulmonary artery has a T-shaped structure, including a main pulmonary artery 530 and two branches (the right pulmonary artery 540 and the left pulmonary artery 550). When the catheter assembly is retrieved after the artificial implant 400 is released, the guide head 311 is retracted proximally. The guide head 311 may be blocked by the artificial implant 400. At this time, the rotation locking mechanism can be unlocked and the core tube can be rotated by the second handle, that is, the spatial posture of the guide head 311 is adjusted so that it can be released from the artificial implant 400 and then withdrawn to the body.

[0175] In the above embodiment, the intervention pathway sequentially passes through the vena cava, the right atrium 510 , and the right ventricle 520 to enter the pulmonary artery 530 .

[0176] In some applications, the catheter assembly also includes an outer sheath located outside the core tube, and the artificial implant is loaded in the loading cavity between the distal end of the outer sheath and the distal end of the core tube. After releasing the artificial implant 400, the distal end of the core tube extends a longer distance out of the outer sheath, and the core tube can be driven by the second handle to quickly retract proximally relative to the first handle until the guide head 311 at the distal end of the core tube is closed with the distal end of the outer sheath, and then the catheter assembly is retracted as a whole outside the body.

[0177] See also Figures 26 to 29 In some embodiments, taking the implantation of the artificial implant 400 into the aorta 560 as an example, the deployment method of the artificial implant 400 includes:

[0178] An interventional route for delivering an artificial implant is preset, and an artificial implant 400 and an interventional delivery system are provided. The interventional route can enter the heart through the apex, the femoral artery, or the carotid artery. The figure takes the femoral artery as an example. The artificial implant 400 adopts an artificial aortic valve, including a stent and leaflets 420, wherein the splicing part of two adjacent leaflets is a joint 421. The artificial aortic valve as a whole has a relative expanded state and a folded state, wherein after loading and during the interventional delivery process, it remains in a radially compressed folded state, and after being delivered to the predetermined position and deployed, it expands radially to an expanded state. The interventional delivery system can adopt the above embodiments, for example, it may include:

[0179] The catheter assembly 300 includes a core tube 310 and an outer sheath 320 that interacts with the outer periphery of the core tube 310 , and the artificial implant 400 is connected to the distal end of the core tube 310 ;

[0180] The control handle includes a first handle 100 and a second handle 200 that can rotate with each other and are correspondingly configured with a controllable rotation locking mechanism. The proximal end of the outer sheath 320 is connected to the first handle 100, and the proximal end of the core tube 310 is connected to the second handle 200.

[0181] The catheter assembly 300 is operated by controlling the handle to deliver the artificial aortic valve along the interventional path to a predetermined position, namely, near the native leaflets 561, where the valve sinuses 562 corresponding to the two native leaflets 561 have coronary artery openings 563 (only one is shown in the figure). In order to avoid the commissure 421 blocking the coronary artery opening 563, the circumferential position needs to be adjusted and aligned before the artificial aortic valve is fully deployed.

[0182] For example, Figure 27 The joint 421 just blocks the coronary artery 563. When adjusting, the second handle 200 can be rotated relative to the first handle 100, so that the artificial aortic valve rotates with the core tube 310. The adjustment is confirmed by imaging equipment or other means. Figure 29 In the position shown, the leaflets 420 are basically aligned with the native leaflets 561, the commissures 421 just avoid the coronary ostia 563, and the artificial aortic valve is fully released.

[0183] like Figure 30In some cases, the artificial implant 400 may be offset in position, and the squeezing of the surrounding tissues may make it difficult to release the connecting ear 411 from the mounting head 313 on the core tube 310, thus affecting the release of the artificial implant 400. In this case, the interventional delivery system of the present application may be utilized, that is, the second handle 200 is rotated relative to the first handle 100, so that the artificial aortic valve rotates with the core tube 310, so that the obstructed part is freed from the squeezing of the surrounding tissues, so as to successfully complete the deployment. In the subsequent process, after the core tube 310 is further withdrawn and the port of the outer sheath tube 320 is closed, the catheter assembly 300 is withdrawn out of the body as a whole.

[0184] like Figure 31 In some cases, after the artificial implant 400 itself is deployed, due to the offset position of the core tube 310, the guide head 311 interferes with the grid structure support of the stent 410, hindering the retraction of the core tube 310. At this time, the interventional delivery system of the present application can be used, that is, the second handle 200 is rotated relative to the first handle 100, so that the core tube 310 rotates relative to the artificial implant 400 to change the spatial posture and eliminate the interference with the artificial implant 400. In the subsequent process, after further retraction and closing the port of the outer sheath 320, the catheter assembly 300 is withdrawn out of the body as a whole.

[0185] In the above embodiments of the deployment method, the first handle 100 and the second handle 200 can be further slidably matched on the basis of rotational matching, and are configured with a controllable sliding locking mechanism, wherein the proximal end of the outer sheath 320 is connected to the first handle 100, and the proximal end of the core tube 310 is connected to the second handle 200. Through the relative sliding of the first handle 100 and the second handle 200, the relative position of the outer sheath 320 and the core tube 310 can be quickly adjusted when the catheter assembly 300 is withdrawn outside the body, and the distal port of the outer sheath 320 is closed by the guide head 311 at the distal end of the core tube 310.

[0186] The technical features of the above-described embodiments may be combined in any manner. To simplify the description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as no contradiction exists between these combinations of technical features, they should be considered to be within the scope of this specification. When technical features in different embodiments are embodied in the same drawing, it can be deemed that the drawing also discloses examples of combinations of the various embodiments involved.

[0187] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, all of which fall within the scope of protection of the present application. Therefore, the scope of patent protection for the present application shall be determined by the appended claims.

Claims

1. Hidden trigger interventional delivery system, characterized by: The interventional delivery system has opposing distal and proximal ends and an axial direction extending between the distal and proximal ends, the interventional delivery system comprising: The catheter assembly comprises a core tube and an outer sheath tube located outside the core tube; The first handle comprises a support body and a connecting piece which is mounted on the support body and slides in the axial direction and is limited in the circumferential direction, wherein the proximal end of the outer sheath is slidably connected to the support body; a second handle, located at the proximal end of the first handle and rotatably mounted on the connecting member, the core tube passing through the connecting member and fixedly connected to the second handle; A rotation locking mechanism, for limiting or allowing the second handle to rotate circumferentially relative to the first handle, the rotation locking mechanism comprising: a limiting portion, provided on the connecting member; a locking member movably disposed within the second handle and circumferentially limited in rotation with the second handle, the locking member and the limiting portion being in a locked state engaged with each other and in an unlocked state separated from each other, wherein the second handle is allowed to rotate relative to the connecting member in the unlocked state, and an operating hole being provided on the outer surface of the second handle for a force-applying member to extend into the second handle and push the locking member toward the unlocked state; The first handle has a proximal end portion fixedly disposed with the support body, and the interventional delivery system further includes a sliding locking mechanism, the sliding locking mechanism comprising: a first positioning groove, arranged around the outer circumference of the proximal portion; a first limiting member, radially slidably installed in the second handle, the first limiting member being annular and having a rib on the inner edge; when the sliding locking mechanism is locked, the first limiting member is sleeved on the outer periphery of the first positioning groove, and the rib extends into the first positioning groove; a first unlocking button, movably embedded in the second handle, and linked with the first limiting member to drive the first limiting member to disengage from the first positioning groove; The first elastic member acts between the second handle and the first limiting member to drive the first limiting member into the first positioning groove. The first unlocking button and the first elastic member are located on two opposite sides of the first limiting member in a radial direction.

2. The hidden trigger-type interventional delivery system according to claim 1, characterized in that: The second handle includes two shells that are buckled with each other, one of the shells is provided with the operating hole, and the locking piece is aligned with the operating hole in the radial direction.

3. The hidden trigger-type interventional delivery system according to claim 2, characterized in that: The area of ​​the operation hole is less than or equal to 10 square millimeters.

4. The hidden trigger-type interventional delivery system according to claim 2, characterized in that: The rotation locking mechanism further comprises: The second elastic member acts between the second handle and the locking member to drive the locking member and the limiting portion into a locked state. The operating hole and the second elastic member are located on two opposite sides of the locking member.

5. The hidden trigger-type interventional delivery system according to claim 1, characterized in that: The locking member is annular and is disposed around the limiting portion, and the locking member has an inner side facing the limiting portion and an outer side opposite thereto; The limiting portion is a groove or a protrusion, and the inner side of the locking member has a clamping portion that matches the shape of the limiting portion.

6. The hidden trigger-type interventional delivery system according to claim 5, characterized in that: A radially extending sliding groove is provided inside the second handle, and the locking member moves along the sliding groove to switch between a locked state and an unlocked state.

7. The hidden trigger-type interventional delivery system according to claim 6, characterized in that: A fixing sleeve is provided on the outer periphery of the connecting member, which protrudes radially outward relative to the connecting member and is partially inserted into the sliding groove. The fixing sleeve is axially restricted by the groove wall of the sliding groove to maintain the axial relative position of the second handle and the connecting member.

8. The hidden trigger-type interventional delivery system according to claim 1, characterized in that: The support body is provided with a guide hole for the connecting member to extend through, and an interacting circumferential limiting structure is provided between the inner wall of the guide hole and the outer wall of the connecting member.

9. The hidden trigger-type interventional delivery system according to claim 8, characterized in that: The circumferential limiting structure includes: a guide groove, provided on the inner wall of the guide hole; The guide rail is arranged on the outer wall of the connecting member, and the guide rail is placed in the guide groove and extends axially.

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