Interventional system for preassembling prosthetic heart valve

Abstract

The invention discloses an intervention system for preassembling a heart valve prosthesis, which comprises a heart valve prosthesis and an intervention conveying system, the intervention conveying system comprises a conveying sheath tube, a core tube and a control handle, the conveying sheath tube comprises a tube body and an operation handle fixedly connected to the near end of the tube body, and the far end of the tube body is provided with a storage bag which is communicated with the tube body and is in running fit with the tube body; the operation handle is provided with an avoiding channel communicated with the pipe body. The core tube is arranged in the conveying sheath tube in a penetrating mode, the heart valve prosthesis is compressed and loaded in a radial gap between the core tube and the containing bag, and the core tube and the conveying sheath tube can slide relative to each other so that the heart valve prosthesis can be exposed out of the containing bag and released. The near end of the core tube extends out of the avoiding channel and is connected with the control handle, the control handle drives the heart valve prosthesis and the storage bag to rotate relative to the operation handle through the core tube so as to adjust the circumferential position of the heart valve prosthesis, the operation safety and controllability are improved, and the operation flexibility is guaranteed.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to interventional systems with pre-loaded artificial heart valves. Background Technology

[0002] Existing interventional systems for delivering and deploying artificial heart valves typically include a control handle, a catheter assembly, and the artificial heart valve housed within the catheter in a compressed state. During delivery, the artificial heart valve remains compressed; upon reaching the target surgical location, its spatial orientation needs adjustment, including rotation around its axis, to better adapt it to the native tissue structure. However, to avoid obstructing this rotation, most current systems require the valve to be partially or completely detached from the catheter and exposed to the body. At this point, the valve may have already expanded to some extent, making it susceptible to contact with surrounding tissues during rotation, posing a risk of injury. Therefore, it is necessary to optimize the system's structure to improve the safety and controllability of the procedure. Summary of the Invention

[0003] This application provides an interventional system pre-loaded with an artificial heart valve, which improves surgical safety and controllability and ensures the flexibility of surgical procedures.

[0004] This application also provides an interventional system pre-loaded with an artificial heart valve, including the artificial heart valve and an interventional delivery system, wherein the interventional delivery system includes: A delivery sheath includes a tube body and an operating handle fixedly connected to the proximal end of the tube body. The distal end of the tube body is provided with a storage pouch that communicates with and is rotatably engaged with the tube body. The operating handle is provided with a clearance channel that communicates with the tube body. The core tube is inserted into the delivery sheath. The artificial heart valve is compressed and loaded in the radial gap between the core tube and the receiving capsule. The core tube and the delivery sheath can slide relative to each other to expose the artificial heart valve to the receiving capsule and allow it to be released. The control handle extends from the proximal end of the core tube into the clearance channel and is connected to the control handle. The control handle drives the artificial heart valve and the storage capsule to rotate relative to the operating handle through the core tube, so as to adjust the circumferential position of the artificial heart valve.

[0005] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.

[0006] Optionally, the storage bag has a cylindrical structure and is rotatably connected to the tube body via a rotary joint.

[0007] Optionally, the rotary joint includes: The first sleeve has its proximal end fixedly connected to the tube body and its distal end having an annular groove. The second sleeve has an annular block at its proximal end that rotates with the annular groove, and its distal end is fixedly connected to the receiving pouch. The annular block and the annular groove are matched to restrict axial separation of the first sleeve and the second sleeve.

[0008] Optionally, the axial joint of the first sleeve and the second sleeve is provided with a corresponding locking hole, and the locking hole also extends into the tube wall of the tube body to the operating handle. A locking wire is movably threaded through the keyhole to maintain or release the circumferential locking of the first sleeve and the second sleeve.

[0009] Optionally, the locking wire extends out of the operating handle, and the extended portion directly serves as the control end.

[0010] Optionally, the operating handle is provided with a first movable element, and the proximal end of the locking wire is connected to and controlled by the first movable element.

[0011] Optionally, the delivery sheath is equipped with a bending adjustment mechanism.

[0012] Optionally, the bending mechanism includes: A bending line is movably inserted through the pipe wall of the pipe body, and the distal end of the bending line is fixed to the pipe body; The second movable component is mounted on the operating handle and is connected to the proximal end of the bending line via a transmission connection.

[0013] Optionally, the artificial heart valve includes a stent and leaflets connected within the stent, and the stent has multiple radiopaque markings to indicate the spatial orientation of the artificial heart valve.

[0014] Optionally, the operating handle and the control handle are provided with a rotation angle indicator that cooperates with each other.

[0015] Optionally, an adjustment mechanism is provided between the operating handle and the control handle to change or lock their axial relative positions along the axial direction.

[0016] Optionally, the proximal end of the operating handle is equipped with a hemostatic valve.

[0017] Optionally, the hemostatic valve includes a housing and a seal disposed within the housing to prevent fluid leakage.

[0018] The interventional system disclosed in this application, after delivering the artificial heart valve to the target location, allows force to be transmitted to the distal end of the core tube by operating a control handle while the artificial heart valve remains completely within the receiving capsule. At this time, the artificial heart valve compressed around the distal end of the core tube, along with the receiving capsule surrounding it, can rotate synchronously with the core tube. This design has the following advantages: Firstly, the rotating fit design between the receiving capsule and the external tube results in minimal frictional resistance, which does not interfere with the rotation operation of the control handle, ensuring flexibility and responsiveness during rotation. Secondly, throughout the entire rotation adjustment process, the artificial heart valve remains confined within the receiving capsule, completely avoiding the risk of damage to surrounding tissues due to direct exposure or premature dilation, thereby significantly improving the safety and controllability of the procedure. Attached Figure Description

[0019] Figure 1 This is a front view of an intervention system according to an embodiment of this application; Figure 2 for Figure 1 A partial cross-sectional view of the distal end of the interventional system; Figure 3 This is a schematic diagram illustrating the delivery of an intervention system to a target location according to an embodiment of this application; Figure 4 for Figure 3 A schematic diagram of the release of an artificial heart valve in a mid-interventional system; Figure 5 for Figure 4 A schematic diagram of artificial heart valve dilation in China; Figure 6 for Figure 5 A schematic diagram of the delivery system of the interventional system being withdrawn from the body; Figure 7 for Figure 2 Enlarged diagram of section A in the middle; Figure 8 for Figure 7 Enlarged diagram showing the center locking line switched to the unlock position; Figure 9 This is a schematic diagram illustrating the calibration between the first sleeve and the second sleeve according to an embodiment of this application. Figure 10 for Figure 2 Enlarged schematic diagram of another embodiment of section A; Figure 11 This is a partial structural view of the operating handle according to an embodiment of this application; Figure 12 for Figure 1 A partial cross-sectional view of the adjustment mechanism between the central operating handle and the control handle in the unlocked position; Figure 13 for Figure 1 A partial cross-sectional view of the adjustment mechanism in the locked position.

[0020] The annotations in the figure are explained as follows: 10. Artificial heart valves; 20. Interventional systems; 40. Native valves; 100. Support frame; 110. Inner frame; 120. Outer frame; 300. Delivery sheath; 310. Tube body; 320. Storage bag; 330. Rotary joint; 331. First sleeve; 3311. Annular groove; 3312. Positioning groove; 3313. Insertion hole; 3314. First connecting part; 3315. First locking hole; 3316. Blocking block; 3317. Socket; 332. Second sleeve; 3321. Annular block; 3322. Positioning block; 3323. Plug; 3324. Second connecting part; 3325. Second locking hole; 3326. Blocking groove; 3327. Guide part; 333. Angle mark; 340. Locking wire; 341. Locking part; 350. Bending line; 400, Core tube; 410, Radial clearance; 420, Balloon body; 430, Guide head; 500, Control handle; 510, Second support body; 520, Third moving part; 600, Operating handle; 610, First support body; 611, First movable component; 620, Hemostatic valve; 630, Clearance passage; 710. Base; 711. Abutment; 712. Sealing ring; 720. Lock cap. Detailed Implementation

[0021] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0022] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0024] In this application, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number or order of the indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0025] This manual describes an artificial heart valve and a delivery system for delivering the artificial heart valve into the patient's body. The delivery system includes a handle and a catheter assembly. The handle connects to and controls the catheter assembly used to perform interventional procedures. The catheter assembly includes multiple receivers, the distal ends of which cooperate to operate the artificial heart valve, such as releasing, retrieving, locking in position, adjusting spatial orientation, etc. Each receiver can be a hollow tube, a solid rod, a flexible wire, or a combination of these. There are multiple receivers, and at least two (taking the proximal end as an example) can slide relative to each other axially or rotate relative to each other about the axial direction. The force-applying components on the handle for operating each receiver (the parts directly operated and contacted by the user) can be directly fixed and driven to the corresponding receiver, or driven by threads, racks, pinions, or other means.

[0026] In the following text, various improvements to the handle or local structure can be implemented on the same handle without obvious technical contradictions, but are not strictly limited to being implemented on the same handle. For different numbers of controlled parts and motion characteristics, or for handles with further simplified structures, each embodiment can also be implemented individually or in appropriate combinations.

[0027] There are no strict restrictions on the application sites and structure of artificial heart valves. Artificial heart valves generally include a deformable stent and leaflets connected within the stent. The stent is cylindrical in shape with a perforated mesh structure on the side walls. Unless otherwise stated, there are no strict restrictions on the shape or size of the mesh structure. The stent contains blood flow channels, and multiple leaflets work together to control the opening and closing of the blood flow channels within the stent. For positioning within the body, positioning structures that can interact with the surrounding native tissues can be placed around the stent. To prevent leakage, skirts or anti-leakage materials can be placed on the inner and / or outer sides of the stent.

[0028] Depending on the expansion mode, the stent is made of different materials, such as nickel-titanium alloy with shape memory that can expand internally, or stainless steel material that expands by ball expansion. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by stitching, bonding or integral molding.

[0029] Taking a self-expanding stent as an example, its expansion and retrieval can be controlled by a sheath wrapped around the stent. The expansion and retrieval can be controlled according to the different parts of the stent exposed in the sheath. It can also be controlled by a pull wire, that is, the pull wire passes through the structural gap (or wire hole structure) of the stent. The degree of stent expansion can be changed by adjusting the tightness of the pull wire by controlling the handle. When the pull wire is pulled out of the stent, the stent is allowed to be completely released. Of course, the control of the pull wire is also accomplished by the various control mechanisms in the catheter assembly.

[0030] Artificial heart valve stents typically have connecting structures that work with the catheter assembly to define their positions and prevent unnecessary displacement during delivery. When implanted, the artificial heart valve is in a radially compressed state, i.e., a loaded state. Once inside the body, it is released from the catheter assembly and radially expanded, becoming an expanded state. Unless otherwise specified, the shape of the artificial heart valve is understood as its expanded state, without considering local deformation caused by pressure from surrounding tissues.

[0031] Due to the complexity of the internal structure, the catheter assembly often requires bending operations. The corresponding bending device can be a tube or wire, with the distal end acting on the component to be bent, and the proximal end operated by a control handle to adjust the bending range or direction.

[0032] When used to indicate direction, the proximal end generally refers to the side closest to the operator (e.g., a doctor), and the distal end is the side relatively far away. Along the interventional path, each component has its own relative distal and proximal ends. Theoretically, when the catheter assembly and handle are fully straightened, the straight line between the proximal and distal ends determines the axis, and correspondingly, the radial direction perpendicular to the axis and the circumferential direction arranged around the axis 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 region in that lateral direction, or a specific structure connected to that point or region.

[0033] It is important to distinguish that the heart valves described in this instruction manual are native tissues and are not the same as artificial heart valves.

[0034] like Figure 1 and Figure 2 As shown, one embodiment of this application provides an interventional system 20 for pre-loading an artificial heart valve 10. The interventional system 20 includes the artificial heart valve 10 and an interventional delivery system (hereinafter referred to as the delivery system for ease of distinction). The delivery system includes a delivery sheath 300, a core tube 400, and a control handle 500.

[0035] The delivery sheath 300 includes a tube body 310 and an operating handle 600 fixedly connected to the proximal end of the tube body 310. A receiving pouch 320 is located at the distal end of the tube body 310, communicating with the interior of the tube body 310 and rotatably engaging around the axial direction of the tube body 310. A control handle 500 and the operating handle 600 are exposed externally for operation. The operating handle 600 has a clearance channel 630 communicating with the interior of the tube body 310, extending axially. The control handle 500 is located proximal to the operating handle 600.

[0036] The core tube 400 passes through the delivery sheath 300, forming a radial gap 410 between itself and the receiving capsule 320. The proximal end of the core tube 400 extends a clearance channel 630 and connects to a control handle 500. The artificial heart valve 10 is compressed and loaded into the distal or near-distal region of the core tube 400, simultaneously within the radial gap 410. The core tube 400 and delivery sheath 300 are slidable relative to each other, exposing the artificial heart valve 10 to the receiving capsule 320 for release. For convenient in vivo delivery, the distal end of the core tube 400 has a guide head 430, which, in the loaded state, is abutted by the distal end of the receiving capsule 320.

[0037] During in vitro assembly, the artificial heart valve 10 is first radially compressed and loaded onto the distal end of the core tube 400. Then, the control handle 500 is inserted from the proximal end of the operating handle 600 into the clearance channel 630 until the artificial heart valve 10 reaches the receiving capsule 320.

[0038] Reference Figures 3 to 6 After the artificial heart valve 10 is delivered to the target surgical position, the operator adjusts the circumferential position of the artificial heart valve 10 using the control handle 500. The specific steps are as follows: The control handle 500 is operated to apply rotational force to the proximal end of the core tube 400. This rotational force is transmitted to the distal end of the core tube, causing the core tube 400 to move axially as follows: Figure 3 The arrow can be rotated in either direction or in the opposite direction, thereby synchronously driving the artificial heart valve 10 and the storage capsule 320 to rotate, so as to adjust the circumferential relative position between the artificial heart valve 10 and the original valve 40.

[0039] Once the circumferential position is determined, such as Figure 4 As shown, the operating control handle 500 pushes the core tube 400 distally in the direction of the arrow, causing the artificial heart valve 10 to move distally, gradually detaching from the receiving capsule 320 and becoming exposed. Subsequently, according to the characteristics of the artificial heart valve 10, a corresponding expansion operation is performed to integrate it with the native valve 40. The specific expansion steps will be described in detail below.

[0040] In this embodiment, because the receiving capsule 320 and the tube body 310 adopt a rotating fit design, the circumferential frictional resistance between them is small, which will not interfere with the rotation operation of the control handle 500, ensuring the flexibility and response speed of the rotation process. Furthermore, throughout the entire rotation adjustment process, the artificial heart valve 10 is always constrained inside the receiving capsule 320, completely avoiding the risk of damage to surrounding tissues due to direct exposure or premature expansion, thereby significantly improving the safety and controllability of the surgery.

[0041] In addition, in existing technologies, the implantation of artificial heart valves is usually performed in steps: first, the axial relationship (including axial distance and angle) between the valve and the target position must be adjusted, and after it is fixed, the valve is released and rotated circumferentially. However, the subsequent circumferential rotation operation is very likely to cause a shift in the calibrated axial position, thus requiring axial calibration again. This iterative process not only significantly increases the complexity of the operation but also further raises the surgical risk.

[0042] In contrast, the interventional system provided in this application supports simultaneous adjustment of the circumferential and axial positions while the artificial heart valve is in a compressed state. After the spatial orientation is fully calibrated, the valve is released all at once. This procedure effectively avoids the axial displacement problem caused by step-by-step adjustments, eliminates the need for recalibrating the axial position after rotation, thus simplifying the operation and further reducing the overall surgical risk.

[0043] See Figure 2 and Figure 7 In one embodiment, the storage pouch 320 has a cylindrical structure and is rotatably connected to the tube body 310 via a rotary joint 330. The rotary joint 330 also prevents axial separation between the storage pouch 320 and the tube body 310. Specifically, the rotary joint 330 includes a first sleeve 331 and a second sleeve 332. The proximal end of the first sleeve 331 is connected to the distal end of the tube body 310, and the distal end has a socket 3317 with an insertion hole 3313. The proximal end of the second sleeve 332 has a plug 3323 that can be inserted into the insertion hole. The inner wall of the insertion hole 3313 has a radially recessed annular groove 3311, and a radially inwardly curved blocking block 3316 is formed at its distal end.

[0044] The plug 3323 is provided with an annular block 3321 that rotatably engages with the annular groove 3311, and an annular blocking groove 3326 is formed on its outer circumferential surface for the blocking block 3316 to engage with. The distal end of the second sleeve 332 is connected to the receiving pouch 320. When the annular block 3321 engages with the annular groove 3311, the blocking block 3316 extends into the annular blocking groove 3326, thereby restricting the two sleeves from separating axially.

[0045] In one embodiment, the first sleeve 331 and the tube body 310 can be integrally formed or connected separately, and the second sleeve 332 and the storage bag 320 can also be integrally formed or connected separately.

[0046] In the preferred embodiment, the first sleeve 331 and the tube body 310 are connected separately, as are the second sleeve 332 and the storage pouch 320. This design allows different materials to be used for each component according to functional requirements. For example, the first sleeve 331 and the second sleeve 332 can be made of metal, which is not only less prone to deformation and has high connection stability, but also effectively reduces the frictional resistance when the two sleeves rotate relative to each other. Metal materials combine high processing precision with ease of manufacturing, which helps to ensure the coaxiality of the two sleeves after assembly. The tube body 310 and the storage pouch 320 can be made of materials such as polymers.

[0047] See again Figure 7 The first sleeve 331 has a gradually narrowing first connecting part 3314 at its proximal end, which is fixedly connected to the tube body 310 by means of heat fusion, welding, bonding or injection molding. Similarly, the second sleeve 332 has a narrowing second connecting part 3324 at its distal end, which is fixedly connected to the storage bag 320 by means of heat fusion, welding, bonding or injection molding.

[0048] To enhance the connection stability between the first sleeve 331 and the tube body 310, and between the second sleeve 332 and the storage pouch 320, at least one of the following methods can be used to increase the bonding force: deformation, scoring, or hollowing out at the connection between the first sleeve 331 and the tube body 310. Similarly, at least one of the following methods can be used to increase the bonding force at the connection between the second sleeve 332 and the storage pouch 320: deformation, scoring, or hollowing out at the connection between the second sleeve 332 and the storage pouch 320. For example, grooves or steps can be machined on the outer peripheral surfaces of the first connecting portion 3314 and the second connecting portion 3324.

[0049] In one embodiment, when the first sleeve 331 and the second sleeve 332 are assembled, a gap for absorbing deformation is provided at the socket 3317 of the first sleeve 331. When the second sleeve 332 is combined with the first sleeve 331, the plug 3323 is inserted into the socket 3313, causing the socket 3317 to switch to a radially outward expanding state. After the two sleeves are combined, the socket 3317 deforms and resets (i.e., radially retracts) to a retracted state to hold the plug 3323, and the blocking block 3316 is then inserted into the blocking groove 3326. Finally, the gap is welded to limit its deformation, or the bonding area is covered to the gap when the tube body 310 is bonded to the first sleeve 331 to limit its deformation.

[0050] The slits are multiple and spaced circumferentially. Each slit extends axially, with its proximal end extending to the proximal end of the insertion hole 3313 and its distal end extending to the distal end of the insertion hole 3313, or continuing to extend to the distal end of the first sleeve 331 to form an opening structure. Of course, a guide portion 3327 is provided at the proximal end of the second sleeve 332, which deforms and expands outward against the distal end of the insertion hole 3313 during assembly. The guide portion 3327 can be a chamfered bevel or an arc surface.

[0051] In another embodiment, the first sleeve 331 is composed of two separate connected parts, which are fixed by a snap-fit ​​method. For example, a locking block is provided on the first connecting portion 3314 of one part, and a locking groove that mates with the locking block is provided on the first connecting portion 3314 of the other part. During assembly, the two parts are assembled with the second sleeve 332 while simultaneously engaging and snapping together. To enhance the connection strength between the two parts, they can be bonded or welded together, or the first connecting portion 3314 can be covered externally by the tube body 310 to achieve overall fixation.

[0052] like Figure 7 and Figure 8 As shown, in one embodiment, the axially joined portions of the first sleeve 331 and the second sleeve 332 are provided with a first locking hole 3315 and a second locking hole 3325 that correspond to each other in position. The first locking hole 3315 extends through the wall of the tube body 310 and extends to the operating handle 600. A locking wire 340 is movably threaded through the two locking holes to achieve or release the circumferential locking between the first sleeve 331 and the second sleeve 332.

[0053] Specifically, the distal end of the locking wire 340 is provided with a locking part 341. The locking part 341 is made of rigid material and is slidably installed in the first locking hole 3315, and has a locking position and an unlocking position that can be extended into or out of the second locking hole 3325. In the locked position, the locking part 341 keeps the two tubes circumferentially locked; in the unlocking position, the lock is released. Before the artificial heart valve 10 is rotated and adjusted, the two tubes are always in a circumferentially locked state to avoid misoperation during delivery.

[0054] The locking part 341 can be integrated into the structure of the locking wire 340 itself, or it can be additionally provided at the distal end of the locking wire 340 as shown in the figure. Morphologically, the locking part 341 is radially enlarged relative to the locking wire 340. In terms of material, the locking wire 340 itself is made of a certain degree of hardness, such as metal wire, which can effectively transmit force, allowing it to be inserted into the tube wall during assembly and to perform relocking operations. Simultaneously, the locking wire 340 is flexible, adapting to the locking wire channel within the tube wall and bending adaptively with the tube body during delivery. The locking part 341, however, is not easily bent to enhance the locking effect.

[0055] like Figure 9As shown, in one embodiment, the distal end of the first sleeve 331 and the proximal end of the second sleeve 332 are provided with circumferential angle markings 333. These markings help to align the angle markings 333 of the two sleeves with each other when the locking wire 340 is threaded through the outside, for example, to make the 0° positions of the two sleeves correspond, thereby ensuring that the first locking hole 3315 is aligned with the second locking hole 3325 so as to smoothly drive the locking wire 340 into the second locking hole 3325.

[0056] In another embodiment, an image of the patient to be evaluated is acquired, which contains at least the location information of each aortic valve sinus. For example, the image to be evaluated may be a view perpendicular to the plane of the native aortic valve annulus, from which the specific location of each aortic valve sinus can be identified and marked.

[0057] The acquired sinus location information is compared with preset baseline information to obtain deviation information. The baseline information is usually derived from the analysis and statistics of baseline images. Since there are individual differences in the sinus location of the native aortic valve in each patient, in order to achieve precise implantation of the artificial heart valve 10, it is necessary to pre-measure the deviation between the current patient's actual sinus location and the baseline information.

[0058] Based on this deviation information, the first relative position between the artificial heart valve 10 and the interventional delivery system is determined. The interventional operator can pre-adjust the circumferential position of the artificial heart valve 10 according to the deviation information, which can be converted, for example, into the difference between the angle markings 333 on the two cannulas. In actual operation, the artificial heart valve 10 is driven to rotate circumferentially by rotating the control handle 500, causing the receiving capsule 320 to rotate synchronously until the angle markings 333 on the two cannulas reach the target difference.

[0059] Furthermore, multiple second locking holes 3325 can be spaced out circumferentially. After the preset position adjustment is completed, the locking wire 340 is driven to perform locking. Another option is to eliminate the locking mechanism between the two sleeves to improve the accuracy of position adjustment; the corresponding locking function can be transferred to the external operating handle 600 and control handle 500, which can also achieve the fixation of the circumferential position of the two sleeves.

[0060] To facilitate observation of the state of the locking wire 340, in one embodiment, the locking wire 340 is provided with a developing indicator. The developing indicator can be designed as a metal piece embedded in the locking wire 340, or the entire locking wire 340 can be made of metal wire and used directly as the developing indicator, or the locking portion 341 located on the locking wire 340 can be used as the developing indicator.

[0061] To ensure smooth sliding of the artificial heart valve 10 and the core tube 400 within the clearance channel 630 during assembly, the inner walls of the first sleeve 331 and the second sleeve 332 feature a smooth transition design. For example... Figure 10As shown, the distal end of the first sleeve 331 is provided with an axially recessed annular positioning groove 3312, and the proximal end of the second sleeve 332 is provided with a matching annular positioning block 3322. Through the cooperation of the annular positioning block 3322 and the annular positioning groove 3312, the coaxiality of the inner walls of the two sleeves can be precisely calibrated, thereby achieving a smooth transition between the inner walls of the first sleeve 331 and the second sleeve 332 after assembly. To reduce the radial dimension of the rotary joint, the second locking hole 3325 extends axially and its inlet is located on the annular positioning block 3322, while the first locking hole 3315 extends axially and its outlet is located in the annular positioning groove 3312.

[0062] like Figure 1 , Figure 10 As shown, in one embodiment, the operating handle 600 includes a first support 610 and a first movable member 611 movably disposed on the first support 610. The proximal end of the locking wire 340 is connected to and controlled by the first movable member 611. For example, the proximal end of the locking wire 340 is provided with a grip portion extending out of the operating handle 600. The grip portion serves as the first movable member 611 and can be a ring-shaped structure. This ring-shaped structure can be formed by winding the locking wire 340 or can be separately connected to the locking wire 340. Alternatively, the first movable member 611 can be axially slidably mounted on the first support 610 and fixedly connected to the proximal end of the locking wire 340.

[0063] The delivery sheath 300 is also equipped with a bending adjustment mechanism for adjusting the orientation of the distal end of the delivery sheath 300. For example... Figure 7 As shown, the bending mechanism includes a bending line 350 and the aforementioned second movable component. The bending line 350 is movably inserted through the wall of the pipe body 310, and its distal end is fixedly connected to the pipe body 310 or the first sleeve 331. For example, the distal end of the bending line 350 is welded to the outer ring of the first connecting portion 3314 of the first sleeve 331. The insertion channels of the bending line 350 and the locking line 340 are interconnected or independent of each other. The second movable component is rotatably mounted on the first support body 610 and is drive-connected to the bending line 350. The form of the drive connection refers to the prior art.

[0064] like Figure 1 and Figure 11 As shown, the proximal end of the operating handle 600 is equipped with a hemostatic valve 620, which itself can employ existing technology. The hemostatic valve 620 includes a housing and a seal located within the housing. The seal can be an elastic element or a fluid-driven deformable element. A clearance passage 630 extends through the hemostatic valve 620, and the core tube 400 prevents blood leakage as it passes through the hemostatic valve 620. The hemostatic valve 620 has a first connection channel for injecting fluid to drive the seal and a second connection channel for venting.

[0065] The control handle 500 includes a second support 510 and a third movable member 520 movably mounted on the second support 510. The proximal end of the core tube 400 is connected to and controlled by the third movable member 520. The third movable member 520 slides axially and is fixedly connected to the proximal end of the core tube 400. When adjusting the circumferential position of the artificial heart valve 10, the control handle 500 is rotated relative to the operating handle 600 to drive the core tube 400, the artificial heart valve 10, and the receiving capsule 320 to rotate synchronously. When releasing the artificial heart valve, the third movable member 520 is driven to move distally, causing the core tube 400, the artificial heart valve 10, and the receiving capsule 320 to move distally synchronously. When retrieving the artificial heart valve 10, the third movable member 520 is driven to move proximally, causing the core tube 400, the artificial heart valve 10, and the receiving capsule 320 to move proximally synchronously.

[0066] To avoid accidental operation, such as Figure 1 , Figure 12 and Figure 13 As shown, an adjustment mechanism is provided between the operating handle 600 and the control handle 500, which is used to change or lock their axial relative positions along the axial direction. Specifically, the adjustment mechanism includes a base 710 fixed to the outer periphery of the core tube 400 and a locking cap 720 slidably sleeved on the outer periphery of the base 710. The locking cap 720 is threadedly connected to the proximal end of the operating handle 600. The base 710 has a radially outwardly expanding abutment portion 711, and the two ends of the locking cap 720 abut against the abutment portion 711 and the control handle 500, respectively. The locking cap 720 has a locked position and an unlocked position. In the locked position, the locking cap 720 moves distally and axially clamps the abutment portion with the operating handle 600, thereby restricting the rotation of the core tube 400. In the unlocked position, the locking cap 720 moves proximally to release the clamping of the base 710, and at the same time, the control handle 500 moves proximally away from the operating handle 600. At this time, the control handle 500 is allowed to rotate relative to the operating handle 600.

[0067] A sealing ring 712 is fitted around the proximal outer ring of the base 710. In the locked position, the sealing ring 712 is clamped between the abutment part 711 and the proximal end of the operating handle 600 to achieve a seal.

[0068] In one embodiment, a rotation angle indicator is provided between the operating handle 600 and the control handle 500, which includes a first angle indicator and a second angle indicator respectively marked on the operating handle 600 and the control handle 500. The angle indicators are circumferentially spaced graduations and have angle values. This angle indicator can also be used for the aforementioned pre-adjustment of the circumferential position of the artificial heart valve 10, which will not be repeated here.

[0069] In one embodiment, the artificial heart valve 10 includes a stent 100 and leaflets connected within the stent. The stent 100 has multiple radiopaque markings to indicate the spatial orientation of the artificial heart valve 10. There are three leaflets arranged circumferentially, with adjacent leaflets connected and sewn to the stent 100. Radiopaque markings are provided on the stent 100 at the junction of the leaflets.

[0070] Describe the release process using one of the stents 100 as an example. (See also...) Figures 3-6 The support structure includes an inner frame 110 and an outer frame 120. The outer frame 120 consists of multiple circumferentially spaced arms and is self-expanding. The inner frame 110 is a ball-expanding type. Figure 3 As shown, after delivery to the target location, the locking cap 720 is rotated to unlock the control handle 500. Based on the image, rotating the control handle 500 drives the artificial heart valve 10, the receiving capsule 320, and the second cannula 332 to rotate to the correct circumferential position. Of course, if the circumferential position has been pre-adjusted based on the image, this step can be omitted, and the process can proceed directly to the next step.

[0071] like Figure 4 As shown in the image, the control handle 500 drives the core tube 400 to move distally, exposing the artificial heart valve 10 outside the receiving capsule 320, and the outer frame 120 expands outward and combines with the native valve 40.

[0072] like Figure 5 As shown, fluid is injected into the core tube 400, causing the balloon body 420 to expand and drive the inner frame 110 to expand outward. Finally, as... Figure 6 As shown, the operating control handle 500 drives the core tube 400 to move proximally and dock with the storage capsule 320, thus withdrawing it from the body.

[0073] The interventional system of this application, after delivering the artificial heart valve to the target location, can transmit force to the distal end of the core tube by operating the control handle while the artificial heart valve is still completely within the receiving capsule. At this time, the artificial heart valve compressed on the outer periphery of the distal end of the core tube and the receiving capsule surrounding it can rotate synchronously with the core tube. This design has the following advantages: First, the rotating fit design between the receiving capsule and the external tube results in minimal frictional resistance, which does not interfere with the rotation operation of the control handle, ensuring the flexibility and responsiveness of the rotation process; second, throughout the entire rotation adjustment process, the artificial heart valve remains confined within the receiving capsule, completely avoiding the risk of damage to surrounding tissues due to direct exposure or premature dilation, thereby significantly improving the safety and controllability of the procedure.

[0074] It should be noted that the methods mentioned in this application can all be used for interventional surgery and also for in vitro simulation training.

[0075] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.

[0076] The above embodiments are merely illustrative of several implementation methods of this application, and their descriptions are quite specific and detailed. However, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.

Claims

1. An interventional system pre-loaded with an artificial heart valve, comprising an artificial heart valve and an interventional delivery system, characterized in that, The intervention delivery system includes: A delivery sheath includes a tube body and an operating handle fixedly connected to the proximal end of the tube body. The distal end of the tube body is provided with a storage pouch that communicates with and is rotatably engaged with the tube body. The operating handle is provided with a clearance channel that communicates with the tube body. The core tube is inserted into the delivery sheath. The artificial heart valve is compressed and loaded in the radial gap between the core tube and the receiving capsule. The core tube and the delivery sheath can slide relative to each other to expose the artificial heart valve to the receiving capsule and allow it to be released. The control handle extends from the proximal end of the core tube into the clearance channel and is connected to the control handle. The control handle drives the artificial heart valve and the storage capsule to rotate relative to the operating handle through the core tube, so as to adjust the circumferential position of the artificial heart valve.

2. The interventional system with a pre-installed artificial heart valve according to claim 1, characterized in that, The storage bag has a cylindrical structure and is rotatably connected to the tube body via a rotary joint.

3. The interventional system with a pre-installed artificial heart valve according to claim 2, characterized in that, The rotary joint includes: The first sleeve has its proximal end connected to the tube body and its distal end having an annular groove. The second sleeve has an annular block at its proximal end that rotatably engages with the annular groove, and its distal end is connected to the receiving pouch. The annular block and the annular groove are matched to restrict axial separation of the first and second sleeves.

4. The interventional system with a pre-installed artificial heart valve according to claim 3, characterized in that, The first sleeve and the second sleeve are provided with corresponding locking holes at their axial joints, and the locking holes also extend into the tube wall of the tube body to the operating handle. A locking wire is movably threaded through the keyhole to maintain or release the circumferential locking of the first sleeve and the second sleeve.

5. The interventional system with a pre-installed artificial heart valve according to claim 4, characterized in that, The locking wire extends from the operating handle, and the extended portion directly serves as the control end.

6. The interventional system with a pre-installed artificial heart valve according to claim 4, characterized in that, The operating handle is provided with a first movable element, and the proximal end of the locking wire is connected to and controlled by the first movable element.

7. The interventional system with a pre-installed artificial heart valve according to claim 1, characterized in that, The delivery sheath is equipped with a bending adjustment mechanism.

8. The interventional system with a pre-installed artificial heart valve according to claim 7, characterized in that, The bending mechanism includes: A bending line is movably inserted through the pipe wall of the pipe body, and the distal end of the bending line is fixed to the pipe body; The second movable component is mounted on the operating handle and is connected to the proximal end of the bending line via a transmission connection.

9. The interventional system with a pre-installed artificial heart valve according to claim 1, characterized in that, The artificial heart valve includes a stent and leaflets connected within the stent. The stent has multiple radiopaque markings to indicate the spatial orientation of the artificial heart valve.

10. The interventional system with a pre-installed artificial heart valve according to claim 1, characterized in that, The operating handle and the control handle are provided with a rotation angle indicator that cooperates with each other.

11. The interventional system with a pre-installed artificial heart valve according to claim 1, characterized in that, An adjustment mechanism is provided between the operating handle and the control handle to change or lock their relative axial positions along the axial direction.

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