Interventional system for artificial implant

Abstract

Disclosed in the present invention is an interventional system for an artificial implant. The interventional system for an artificial implant has a distal end and a proximal end which are opposite to each other, and, taken as a whole, has an axial direction when straightened and corresponding radial and circumferential directions. The interventional system comprises: a control handle having a top side and a bottom side which are opposite to each other in the radial direction, wherein the control handle has a use state in which the top side faces upwards, and the control handle is provided with a reference mark for indicating the use state; a catheter assembly having a proximal end connected to and controlled by the control handle; and an artificial implant provided with a first visualization mark and loaded to a distal end of the catheter assembly according to a preset included angle, wherein the preset included angle corresponds to a circumferential offset amplitude between the first visualization mark and the reference mark when the control handle is in the use state. The interventional system can achieve rapid registration and release of the artificial implant.

Description

Interventional systems for artificial implants Technical Field

[0001] This application relates to the technical field of medical devices, specifically an interventional system for artificial implants. Background Technology

[0002] In transvascular techniques, a pre-loaded artificial valve is attached to the distal portion of a flexible catheter and advanced through the patient's blood vessels until the valve reaches the implantation site. The artificial valve at the catheter tip expands to its functional size at the site of the diseased natural valve.

[0003] In interventional prosthetic valve implantation surgery, it is desirable for the commissure of the implanted artificial heart valve to align with the commissure of the native aortic valve, preventing the artificial valve leaflets from obstructing coronary blood flow. To achieve this, existing techniques typically involve rotating the artificial heart valve during implantation (e.g., rotating the delivery system to rotate the valve as well) to adjust its circumferential position, thereby aligning the commissure of the artificial heart valve with that of the native valve.

[0004] However, this method of aligning artificial heart valves by rotating them has the following problems:

[0005] Typically, delivery systems have long sheaths, and human blood vessels are often tortuous. Rotating the delivery system at the handle cannot effectively transmit the force to the distal artificial heart valve. Rotating the handle a certain degree does not necessarily mean the artificial heart valve will rotate the same degree. Besides the excessive sheath length, this is also affected by the sheath's resistance to kinking, resulting in poor rotation and difficulty in control. Furthermore, rotating the delivery system may cause blood clots to dislodge, posing a certain risk. Summary of the Invention

[0006] This application provides an interventional system for artificial implants, which enables the artificial implants to meet a specific circumferential preset angle during loading, so that they can be aligned with the native valve without adjusting the circumferential position during the implantation process.

[0007] This application provides an interventional system for an artificial implant, having a distal and a proximal end, wherein the interventional system as a whole has an axial direction after straightening and corresponding radial and circumferential directions, the interventional system comprising:

[0008] A control handle having opposing top and bottom sides in the radial direction, the control handle having a top-facing use position, and the control handle having a reference mark for indicating the use position;

[0009] A catheter assembly, the proximal end of which is connected to and controlled by the control handle;

[0010] An artificial implant having a first imaging marker, the artificial implant being mounted at a preset angle to the distal end of the catheter assembly, the preset angle corresponding to the circumferential offset between the first imaging marker and the reference marker when the control handle is in use.

[0011] 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.

[0012] Optionally, the artificial implant is secured and releasably mounted on the catheter assembly via a locking suture. The control handle includes a support body, a base slidably mounted on the support body for pulling the locking suture, and a drive sleeve rotatably fitted onto the support body and threadedly driven with the base. The control handle further includes a rotation locking mechanism that restricts or allows rotation of the drive sleeve, the rotation locking mechanism comprising:

[0013] The first pipe fitting is fixed to the support body;

[0014] The second pipe fitting is rotatably sleeved on the outer periphery of the first pipe fitting. A portion of the second pipe fitting is a working section that extends into the drive sleeve. The outer wall of the working section has protrusions.

[0015] A locking element is located within the radial gap between the working section and the drive sleeve, and is configured to slide radially along the drive sleeve and act on the inner wall of the drive sleeve. During the rotation of the second tube, the locking element moves via the protrusion and locks the drive sleeve accordingly.

[0016] Optionally, the locking thread has a second imaging marker that has axial and radial displacement relative to the catheter assembly during the release of the implant. The second imaging marker has the largest radial displacement when the implant expands radially to its maximum extent.

[0017] Optionally, the artificial implant includes a stent and multiple leaflets connected to the stent. The stent has a connecting portion in the circumferential direction corresponding to the splicing parts of adjacent leaflets, and the circumferential positions of the first imaging mark and the second imaging mark correspond to one of the connecting portions.

[0018] Optionally, the artificial implant is an artificial heart valve, which has an inflow end and an outflow end, including,

[0019] The support is cylindrical and has a mesh structure;

[0020] A skirt, which is sewn to the inlet end of the stent to form a blood flow channel with the stent;

[0021] Multiple leaflets are sewn to the outflow end of the skirt. Each leaflet is located within the blood flow channel and cooperates with each other to control the interruption of blood flow. The leaflets include a fixed edge that connects to the skirt and fixes it to the support, and a free edge that cooperates with adjacent leaflets to control the blood flow channel. The artificial heart valve has a third imaging marker at a position near the inflow end.

[0022] Optionally, the farthest endpoint of the leaflet fixing edge is connected to the support grid node.

[0023] Optionally, the third imaging marker is axially misaligned with the farthest endpoint of the leaflet fixing edge.

[0024] Optionally, the valve includes an inflow area, a valve area, and an outflow area. The inflow area consists of at least one row of circumferentially distributed diamond-shaped grids, with adjacent cells interconnected circumferentially to form interconnection points. The third imaging marker is located at the interconnection point.

[0025] Optionally, the control handle is held in use by its own shape or positioning device, wherein:

[0026] The shape itself includes a resting surface or multiple support parts on the bottom side;

[0027] The positioning device and the control handle are provided with a corresponding coupling structure.

[0028] Optionally, the control handle includes a first handle and a second handle that cooperate with each other, and the catheter assembly includes:

[0029] The outer sheath is connected to the first handle at its proximal end and is used to cover the artificial implant at its distal end.

[0030] The third shaft has its proximal end fixed to the second handle, and its distal end is connected to a lock seat with a lock hole.

[0031] The second shaft is connected to the second handle at its proximal end, and the locking wire is connected to the distal end of the second shaft. The locking wire passes through the artificial implant and is connected to the locking seat to restrain or release the artificial implant.

[0032] A first shaft, with its proximal end connected to the second handle, and a locking rod connected to its distal end to maintain the connection between the locking line and the locking seat.

[0033] Optionally, the first handle includes a first support body and a strut fixed to the first support body and extending further proximally, and the second handle includes a second support body slidably mounted on the strut, and a sliding locking mechanism that interacts with the strut is provided on the distal side of the second support body itself.

[0034] Optionally, the lock base includes a guide portion, a reduced diameter portion, and a connecting portion in sequence from the distal end to the proximal end, wherein the connecting portion is provided with a lock hole and a wire hole, the guide portion is provided with a guide hole corresponding to the position of the lock hole, the outer periphery of the reduced diameter portion is a radially open engagement area, and the distal end of the connecting portion has a convergent shape and forms an extended area on its outer periphery that communicates with the engagement area.

[0035] Optionally, the locking rods are multiple and of different lengths, and in the released position, the proximal ends of all the locking rods are located in the guide holes of the guide portion.

[0036] This application also provides a method for releasing an artificial implant based on in vitro simulation, including:

[0037] Provide artificial prostheses;

[0038] The artificial implant with the first imaging mark is loaded into the interventional delivery system with the reference mark, and the circumferential relative position of the first imaging mark and the reference mark is adjusted according to the preset angle;

[0039] During the release process, the overall circumferential position of the intervention delivery system is maintained so that the artificial implant is positioned in the preset matching posture.

[0040] The interventional system for artificial implants provided in this application enables the artificial implant to meet a specific circumferential preset angle during loading, so that it can be aligned with the native valve without adjusting the circumferential position during the implantation process.

[0041] This application also provides a wire control mechanism for an artificial implant, having a distal end and a proximal end, the wire control mechanism comprising:

[0042] A lock base includes a guide portion, a reduced diameter portion, and a connecting portion arranged sequentially. The connecting portion is provided with a lock hole and a wire hole. The guide portion is provided with a guide hole corresponding to the position of the lock hole. The outer periphery of the reduced diameter portion is a radially open engagement area. The distal end of the connecting portion has a convergent shape and forms an extended area on its outer periphery that communicates with the engagement area.

[0043] A locking rod is slidably engaged with the lock seat and inserted into the lock hole via the guide hole;

[0044] The locking wire has a driving end at one end, which extends proximally through the wire hole, and a working end at the other end, which is used to thread around the artificial implant and then connect to the locking rod.

[0045] 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.

[0046] Optionally, the distal ends of the lock hole and wire hole on the connector are exposed in the extended area.

[0047] This application also provides a delivery system for an artificial implant, having a distal end and a proximal end. The delivery system includes a control handle and a wired control mechanism connected proximally to the control handle. The artificial implant is connected to the distal end of the wired control mechanism and controlled by the control handle. The control handle is used to drive a locking lever to lock and release the artificial implant.

[0048] Optionally, the control handle includes a support body with a guide groove, a base that moves along the guide groove, and a drive sleeve rotatably mounted on the periphery of the support body, wherein the drive sleeve and the base are threadedly connected.

[0049] Optionally, the support body is provided with a rotation locking mechanism on one side of its guide groove to restrict or allow the rotation of the drive sleeve, the rotation locking mechanism comprising:

[0050] The first pipe fitting is fixed to the support body, and the control handle has an axially penetrating installation channel through the support body, a portion of which extends through the interior of the first pipe fitting.

[0051] The second pipe fitting is rotatably sleeved on the outer periphery of the first pipe fitting. A portion of the second pipe fitting is a working section that extends into the drive sleeve. The outer wall of the working section has protrusions.

[0052] A locking element is located within the radial gap between the working section and the drive sleeve, and is configured to slide radially along the drive sleeve and act on the inner wall of the drive sleeve. During the rotation of the second tube, the locking element moves via the protrusion and locks the drive sleeve accordingly.

[0053] The operating component drives the second pipe to rotate.

[0054] 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.

[0055] Optionally, the delivery system for the artificial implant further includes:

[0056] Inner sheath, the locking seat is fixed to the distal end of the inner sheath;

[0057] The inner core is slidably inserted into the inner sheath tube. The distal end of the inner core protrudes from the lock seat, and the protruding portion is fixed with the lock rod. The lock rod moves with the inner core and has the following positions:

[0058] In the locking position, the locking rod is inserted into the locking hole to restrain the working end of the locking wire;

[0059] In the release position, the locking rod disengages from the lock hole to release the working end of the locking cable.

[0060] The wire control tube is slidably inserted into the radial gap between the inner core and the inner sheath tube, and the drive end of the locking wire is connected to the wire control tube.

[0061] Optionally, the locking rods are multiple and of different lengths, and in the released position, the proximal ends of all the locking rods are located in the guide holes of the guide portion.

[0062] Optionally, the support includes:

[0063] The main body is columnar and extends axially along the control handle, with the first tube located on the proximal end side of the main body;

[0064] A connecting seat is fixed to the near end of the main body and has a radial gap between it and the first pipe fitting, and the radial position of the second pipe fitting is located in the radial gap.

[0065] Optionally, the connecting seat has a radially through guide groove, and the locking member includes a first locking member that is slidably disposed in the guide groove, and the protrusion on the second tube abuts against the radially inner side of the first locking member.

[0066] Optionally, the locking element further includes:

[0067] The second locking member is radially engaged with the connecting seat, and the first locking member and the second locking member move synchronously in opposite directions.

[0068] Optionally, the height of the outer surface of the protrusion gradually increases along the circumference of the second pipe.

[0069] Optionally, the second fitting has the following relative features:

[0070] In the locked position, the protrusion abuts against the locking member and acts on the drive sleeve;

[0071] In the release position, the protrusion and the locking member release their clamping force;

[0072] The locking element has an arcuate or radially undulating structure that mates with the protrusion.

[0073] The wire control mechanism provided in this application uses a locking wire to connect the artificial implant to the delivery system. The locking wire allows for precise and controlled release of the artificial implant from the sheath. Furthermore, once the artificial implant has completely detached from the sheath, it can be retrieved back into the sheath and released again using the locking wire. Moreover, improvements to the locking seat structure make the release and retrieval processes easier, safer, and more stable. Attached Figure Description

[0074] Figure 1a is a structural view of a conveying system according to an embodiment of this application;

[0075] Figure 1b is a structural view of an artificial heart valve according to an embodiment of this application;

[0076] Figure 2 is a structural view of the control handle in Figure 1a;

[0077] Figure 3 is a schematic diagram of the structure in Figure 1a where the second handle slides towards the proximal end relative to the first handle;

[0078] Figure 4 is a cross-sectional view of the control handle in Figure 2 along its own axis;

[0079] Figure 5 is an exploded view of the second handle in the control handle of this application;

[0080] Figure 6 is an enlarged view of part A in Figure 1a;

[0081] Figure 7 is a partial structural view of the wire control mechanism of an embodiment of this application when the locking rod and the locking seat are engaged;

[0082] Figure 8 is a cross-sectional view of a catheter assembly according to an embodiment of this application;

[0083] Figure 9 is a schematic diagram of the state when the artificial implant is released at the distal end of the delivery system according to an embodiment of this application and the locking wire is released;

[0084] Figure 10 is a schematic diagram of the state when the delivery system of an embodiment of this application releases the artificial implant and the locking wire at the distal end;

[0085] Figure 11 is an exploded view of the support rod and the first handle in a control handle according to an embodiment of this application;

[0086] Figure 12 is an exploded view of the sliding locking mechanism in the control handle according to an embodiment of this application;

[0087] Figure 13 is an enlarged view of part B in Figure 4 (the sliding locking mechanism is in the locked state);

[0088] Figure 14 is an enlarged view of part B in Figure 4 (the sliding locking mechanism is in the unlocked state);

[0089] Figure 15 is an exploded view of the second half-shell and the second drive sleeve in the control handle of an embodiment of this application;

[0090] Figure 16 is an exploded view of the operation button in the control handle according to an embodiment of this application;

[0091] Figure 17 is an exploded view of the control handle in Figure 2 between the rotating component and the support body;

[0092] Figure 18 is an exploded view of the locking element and half-shell in Figure 1a7;

[0093] Figure 19 is a front view of a control handle according to an embodiment of this application;

[0094] Figure 20 is a cross-sectional view in the FF direction (locking device in the unlocked state) of Figure 19;

[0095] Figure 21 is a cross-sectional view in the FF direction (with the locking device in the locked state) of Figure 19;

[0096] Figure 22 is a structural view of a locking member (first locking block) according to an embodiment of this application;

[0097] Figure 23 is a partial structural view of the control handle of an embodiment of this application when the second handle is in the second extreme position;

[0098] Figure 24 is a structural view of the interlocking structure between the support rod and the slide groove in a control handle according to an embodiment of this application;

[0099] Figure 25 is a structural schematic diagram of the lock seat in this application;

[0100] Figure 26 is a schematic diagram of the lock seat in this application;

[0101] Figure 27 is a schematic diagram of the E-direction view in Figure 26;

[0102] Figure 28 is a schematic diagram of the GG cross-section of the lock seat in Figure 27;

[0103] Figure 29 is a schematic diagram showing the alignment of the first developing mark and the reference mark (for illustrative purposes only);

[0104] Figure 30 is a schematic diagram showing the position of the first developing mark and the reference mark having a preset angle (for schematic purposes only);

[0105] Figure 31 is a schematic diagram of releasing the artificial implant via a control handle;

[0106] Figure 32 is a schematic diagram of the position of the artificial implant after release when the first imaging marker and the reference marker are aligned and at an angle. Detailed Implementation

[0107] Referring to Figures 1a-9 and 29-30, this application provides an interventional system for an artificial implant 100, having a distal and a proximal end. The interventional system as a whole has an axial direction after straightening, as well as corresponding radial and circumferential directions (the directions of the axial, radial, and circumferential directions are shown in the coordinate system in the upper right corner of Figure 29). The interventional system includes:

[0108] The control handle 400 has a top side and a bottom side opposite each other in the radial direction. The control handle 400 has a top side facing upwards in use. The control handle 400 has a reference mark 241 for indicating the use status.

[0109] Catheter assembly 200, the proximal end of which is connected to and controlled by control handle 400;

[0110] Artificial implant 100, artificial implant 100 having a first imaging mark 332, artificial implant 100 being loaded onto the distal end of catheter assembly 200 at a preset angle, the preset angle corresponding to the circumferential offset between the first imaging mark 332 and reference mark 241 when the control handle 400 is in use.

[0111] The catheter assembly 200 in the interventional system has a certain length and can be bent. In this application, when referring to axial, radial and circumferential directions, it means that the control handle 400 and the catheter assembly 200 are in the straightened state.

[0112] The control handle 400 has a top side and a bottom side in the radial direction. The top side and the bottom side are relative concepts. As shown in Figure 1a, when the control handle 400 is placed flat on the horizontal plane, the bottom side of the control handle 400 is in contact with the horizontal plane, and the top side is the top side.

[0113] Reference mark 241 on control handle 400 is used to indicate the usage status of control handle 400. In the usage status, control handle 400 is kept with its top side facing upward, and control handle 400 is kept in this top side facing upward usage status to release artificial implant 100.

[0114] The control handle 400 remains in the top-facing position to prevent it from rotating in its circumferential direction. Movement in other directions does not affect the release process.

[0115] The control handle 400 is kept in use by its own shape or positioning device, wherein: its own shape includes a resting surface on the bottom side or multiple support parts; and a corresponding coupling structure is provided between the positioning device and the control handle 400.

[0116] Reference mark 241 and the support surface have a fixed positional relationship in the circumferential direction. For example, reference mark 241 and the support surface are respectively located on both sides of the radial direction of the control handle. That is, when the axis of the control handle is parallel to the horizontal plane, reference mark 241 and the support surface are located at the top and bottom of the control handle, respectively. When reference mark 241 rotates around the circumference of the control handle 400, the support surface also rotates synchronously by a corresponding angle. The positional relationship between reference mark 241 and the support is the same as the positional relationship between reference mark 241 and the support surface.

[0117] Specifically, when a resting surface or multiple support parts are provided on the control handle 400, during use, the resting surface or support parts are fixed on a certain support plane. The support plane can be provided by an object that is fixed in space and will not move at will, such as an operating table. The resting surface or support parts on the control handle 400 cooperate with the support plane to prevent the control handle 400 from rotating in the circumferential direction.

[0118] The positioning device can be a clamping device that cooperates with the control handle 400 to limit the circumferential rotation of the control handle 400, or a concave-convex structure that cooperates with the surface of the control handle 400 to prevent the control handle 400 from rotating in the circumferential direction.

[0119] The artificial implant 100 has a first imaging mark 332, which is used to indicate the circumferential position of the artificial implant 100.

[0120] Referring to Figure 10, the locking thread 33 has a second imaging marker 331. During the release of the implant 100, the second imaging marker 331 has axial and radial displacement relative to the catheter assembly 200. When the implant 100 expands radially to its maximum extent, the second imaging marker 331 has the largest radial displacement. The movement trajectory of the locking thread 33 is completely different from the movement trajectory of the first imaging marker 332 on the stent 110. The second imaging marker 331 on the locking thread 33 is used to assist in determining the release pattern of the implant 100 during the release process.

[0121] Taking the artificial heart valve shown in Figures 1b, 6, and 32 as an example, the artificial heart valve includes a cylindrical stent 110 with a mesh structure, a skirt, and multiple leaflets 120. The skirt is sutured to the bottom of the stent, forming a blood flow channel with the stent; the multiple leaflets 120 are sutured to the outflow end of the skirt, each leaflet is located within the blood flow channel and cooperates with each other to control the interruption of blood flow. The edge of each leaflet includes a fixed edge 160 that connects to the skirt and fixes it to the stent, and a free edge 150 that cooperates with other leaflets to control the blood flow channel. The distal end 161 of the fixed edge 160 of the leaflet is connected to the mesh node of the stent.

[0122] The support 110 has connecting portions 130 in the circumferential direction corresponding to the splicing parts of adjacent leaflets 120. The circumferential positions of the first development mark 332 and the second development mark 331 correspond to one of the connecting portions 130. In Figure 6, the circumferential positions of the first development mark 332 and the second development mark 331 correspond to one of the connecting portions 130. That is, there are three connecting portions 130, located at three different positions in the circumferential direction, and the first development mark 332 and the second development mark 331 are aligned with the connecting portions 130 in the axial direction.

[0123] The circumferential position of the second imaging mark 331 corresponds to the joint portion 130, meaning that when the artificial implant 100 is radially expanded to its maximum state, the second imaging mark 331 is aligned with the joint portion 130 in the axial direction. If the artificial implant 100 is not radially expanded to its maximum state, there is no alignment relationship between the second imaging mark 331, the first imaging mark 332, and the joint portion 130 at the splicing part of the leaflet 120.

[0124] The first imaging marker 332 consists of at least two imaging points, and the second imaging marker 331 includes multiple imaging points, the number of which corresponds to the number of locking wires 33. See Figure 10; the second imaging marker 331 has three imaging points. For an artificial heart valve, the leaflets 120 consist of three pieces, and the connecting portions 130 at the joints of adjacent leaflets 120 also consist of three pieces. The first imaging point consists of at least two imaging points, each imaging point aligned axially with one of the connecting portions 130 (i.e., the line connecting the imaging point and the connecting portion 130 is coplanar with the axis). Two or more imaging points are aligned axially with different connecting portions 130. The imaging points of the second imaging marker 331 are aligned axially with one of the connecting portions 130 when the artificial implant 100 (e.g., a heart valve) is radially expanded to its maximum state.

[0125] The implant has an inflow end and an outflow end, with a third imaging marker located near the inflow end. The implant has a grid structure, with the third imaging marker positioned at each node of the grid. Axially, the distance between the third imaging marker and the inflow end is 0.5 to 2 cell heights. After the implant is placed at the target location, the third imaging marker indicates the implantation depth, which is the axial implantation position relative to the native valve.

[0126] The artificial heart valve includes an inflow area C, a valve area B, and an outflow area A, bounded by the fixed edge 160 and the free edge 150 of the leaflet. The section from the farthest inflow end of the valve stent to the farthest endpoint 161 of the fixed edge 160 of the leaflet is the inflow area C; the leaflet section is the valve area B; and the section from the free edge 150 of the leaflet to the nearest outflow end of the valve stent is the outflow area A. The inflow area consists of at least one row of circumferentially distributed rhomboid grids 170, with adjacent cells interconnected circumferentially to form interconnection points. The third imaging marker is located at an interconnection point. The third imaging marker is axially offset from the farthest endpoint of the fixed edge of the leaflet. In this embodiment, the inflow area consists of a row of circumferentially distributed rhomboid grids 170, with adjacent cells interconnected circumferentially to form interconnection points. The third imaging marker 180 is located at an interconnection point, meaning that axially, the distance between the third imaging marker 180 and the inflow end is 0.5 cell (rhomboid grid) height, approximately 4-9 mm.

[0127] The implant delivery system has a distal end 402 and a proximal end 401. The system includes a control handle 400 and a catheter assembly 200 connected proximally to the control handle 400. The implant 100 is connected to the distal end of the catheter assembly 200 and controlled by the control handle 400. The control handle 400 includes a first handle 41 and a second handle 42 that cooperate with each other. Each handle includes a support member and a drive mechanism disposed on the support member. Multiple drive mechanisms are configured, each connected to a portion of the catheter assembly, to control a wired control mechanism located at the distal end of the catheter assembly to perform actions such as expansion, release, and retrieval of the implant. The support member provides a base for the installation and movement of the drive mechanism and / or another handle, as well as structural support for the corresponding handle.

[0128] The support components in the first handle 41 include a first support body 410 and two struts 450 fixedly connected to the first support body 410 and extending proximally. The support components in the second handle 42 include a second support body 420 slidably mounted on the struts 450. Each support body has a guide groove extending axially. The drive mechanism includes a base that slides along the axis and a drive sleeve rotatably mounted on the outer periphery of the corresponding support body. The drive sleeve and the base are connected by a threaded drive. Some components in the conduit assembly are connected to the base and complete corresponding actions under the drive of the drive sleeve.

[0129] Each support body is provided with a rotation locking mechanism on the proximal side of its own guide groove, which can restrict or allow the drive sleeve to rotate. The second support body 420 is also provided with a sliding locking mechanism on its distal side. The sliding locking mechanism interacts with the support rod 450 to maintain the relative position with the first support body 410.

[0130] The catheter assembly 200 includes, from the outside to the inside, an outer sheath 240 and at least one shaft, wherein one shaft refers to one or more shafts fixed together, for example, two tubes fixed relative to each other can also be regarded as one shaft. As shown in Figure 8, the catheter assembly 200 specifically includes an outer sheath 240, a third shaft (e.g., an inner sheath 230 below), a second shaft (e.g., a wire control tube 220 below), and a first shaft (e.g., an inner core 210 below).

[0131] Referring to Figures 4-10, the proximal end of the outer sheath 240 is movably connected to the first base 491 in the first handle 41, and the distal end is used to wrap the artificial implant 100; the proximal end of the third axis is fixed to the second handle 42, the proximal end of the second axis is movably connected to the second base 492 in the second handle 42, and the proximal end of the first axis is movably connected to the proximal portion of the second handle 42. Since the first, second, and third axes are all controlled by the second handle 42, when the sliding locking mechanism is unlocked, the second handle 42 can move relatively away from or closer to the first handle 41, thereby simultaneously driving the first, second, and third axes to move rapidly relative to the outer sheath 240.

[0132] In one embodiment, the distal end of the first support 410 is further fixed with a first extension sleeve 418, and the catheter assembly 200 also includes a sheath 250 sleeved outside the outer sheath 240 and fixed proximally to the first handle 41.

[0133] The distal end of the inner sheath 230 is connected to a locking seat 31. One end of the inner core 210 is an extension extending from the distal end of the inner sheath 230. A locking rod 32 is fixed to the extension and is located on the distal side of the locking seat 31. The distal end of the wire control tube 220 is connected to a locking wire 33. The locking wire 33 passes through the artificial implant 100 and tightens or loosens at the locking seat 31 to restrain or release the artificial implant 100. The locking seat 31, the locking wire 33, and the locking rod 32 constitute the aforementioned wire control mechanism.

[0134] Referring to Figures 25, 26, 27, and 28, the wire control mechanism of the artificial implant has a distal and a proximal end, and the wire control mechanism includes:

[0135] The lock base 31 includes, from the distal end to the proximal end, a guide portion 311, a reduced diameter portion 312, and a connecting portion 313. The connecting portion 313 is provided with a lock hole 315 and a wire hole 314. The guide portion 311 is provided with a guide hole 316 corresponding to the position of the lock hole 315. The outer periphery of the reduced diameter portion 312 is a radially open engagement area 317. The distal end of the connecting portion 313 has a converging shape and forms an extension area 318 on its outer periphery that communicates with the engagement area 317.

[0136] The locking rod 32 is slidably engaged with the locking seat 31 and inserted into the locking hole 315 via the guide hole 316;

[0137] The locking wire 33 has a driving end at one end, which extends proximally through the wire hole 314, and a working end at the other end, which is used to pass through the artificial implant and then connect to the locking rod 32.

[0138] The structure of the lock base 31 in the prior art is shown in Figure 7. The lock base 31 includes a guide part 311, a reduced diameter part 312, and a connecting part 313. The connecting part 313 is generally cylindrical and has a lock hole 315 and a wire hole 314. When the lock rod 32 is inserted into the lock hole 315 of the connecting part 313 through the guide hole 316 in the guide part 311, it needs to be precisely aligned. Since the dimensions of the lock rod 32, the lock hole 315, and the guide hole 316 are all small, the processing accuracy requirements are extremely high. At the same time, when the working end of the lock wire 33 is threaded around the artificial implant, the operation is carried out in the outer area of ​​the reduced diameter part 312 (i.e., the coupling area 317), the operating space is small, and the line of sight is easily obstructed.

[0139] In this application, the structure of the lock base 31 is shown in Figures 25, 26, and 27. The distal end of the connecting portion 313 of the lock base 31 has a converging shape and forms an extension area 318 on the outer periphery that communicates with the bonding area 317. The distal ends of the lock hole 315 and the wire hole 314 on the connecting portion 313 are exposed in the extension area 318. The area of ​​the extension area 318 is shown by the dashed box in Figure 26. It is a region surrounding the connecting portion 313 with a triangular cross-section. This region is the area of ​​operable locking wire 33 that is additional to the bonding area 317 around the lock base 31 in the prior art. As shown in Figure 28, the lock hole 315 and the wire hole 314 on the connecting portion 313 are both exposed in the extension area 318. The locking wire 33 passes through the wire hole 314 and connects to the artificial implant. The opening size of the wire hole 314 is relatively large, so the locking wires 33 are less likely to get tangled. At the same time, the line of sight is better when passing through the artificial implant.

[0140] As shown in Figure 28, the opening of the lock hole 315 is relatively large, and the opening of the lock hole 315 is on an inclined surface. When the lock rod 32 is to be inserted into the lock hole 315, it is guided into the lock hole 315 by the inclined surface, which reduces the difficulty of alignment.

[0141] This application also provides a delivery system for an artificial implant, having a distal end and a proximal end. The delivery system includes a control handle 400 and a wired control mechanism connected to the control handle 400 at the proximal end. The artificial implant is connected to the distal end of the wired control mechanism and is controlled by the control handle 400.

[0142] The control handle 400 includes a support body (i.e., the first support body 410) with a guide groove (i.e., the first guide groove 4102), a base (i.e., the first base 491) that moves along the guide groove, and a drive sleeve (i.e., the first drive sleeve 481) that is rotatably mounted on the outer periphery of the support body. The drive sleeve and the base are connected by a threaded transmission.

[0143] The support body has a rotation locking mechanism 460 on the proximal side of its own guide groove to restrict or allow the rotation of the drive sleeve. The rotation locking mechanism 460 includes:

[0144] The first pipe fitting 461 is fixed to the support body. The control handle 400 has an axially penetrating installation channel 403 that runs through the support body. A portion of the installation channel 403 extends through the interior of the first pipe fitting 461.

[0145] The second pipe fitting 462 is rotatably sleeved on the outer periphery of the first pipe fitting 461. A portion of the second pipe fitting 462 is a working section 4621 that extends into the drive sleeve. The outer wall of the working section 4621 has a protrusion 4622.

[0146] Locking member 463 is located in the radial gap between working section 4621 and drive sleeve, and is configured to slide radially along drive sleeve and act on the inner wall of drive sleeve. During the rotation of second tube 462, it moves by pressing locking member 463 against protrusion 4622 and locks drive sleeve accordingly.

[0147] Operating component 464 drives the second pipe component 462 to rotate.

[0148] The delivery system for artificial implants also includes:

[0149] The inner sheath tube 230 is fixed to the distal end of the inner sheath tube 230 by the locking seat 31;

[0150] The inner core 210 is slidably inserted into the inner sheath tube 230. The distal end of the inner core 210 protrudes from the lock seat 31, and the protruding part is fixed with a locking rod 32. The locking rod 32 moves with the inner core 210 and has the following positions:

[0151] Locked position, locking rod 32 is inserted into lock hole 315 to restrain working end of locking wire 33;

[0152] Release position: Locking rod 32 disengages from lock hole 315 to release the working end of locking cable 33.

[0153] The wire control tube 220 is slidably inserted in the radial gap between the inner core 210 and the inner sheath tube 230, and the drive end of the locking wire 33 is connected to the wire control tube 220.

[0154] There are multiple locking rods 32 of varying lengths. In the released position, the proximal ends of all locking rods 32 are located within the guide holes 316 of the guide portion 311. Referring to Figure 26, there can be at least two, three, or more locking rods 32, each with a different length. The axial length of the guide portion 311 is made relatively long to ensure that when the locking rods 32 are in the released position, the proximal ends of all locking rods 32 are also located within the guide holes 316 of the guide portion 311, rather than being exposed outside the guide portion 311. Because the proximal ends of the locking rods 32 remain continuously within the guide holes 316, the locking rods 32 and the lock seat 31 maintain a constant connection, allowing the locking rods 32 to switch between the locked and released positions more smoothly and safely.

[0155] When the implant 100 is in the loaded state, the locking wire 33 extends from the distal end of the inner sheath 230, passes around the implant 100, and is secured to the locking lever 32. The locking lever 32 and the locking seat 31 are engaged to prevent the locking wire 33 from being released. The proximal end of the locking wire 33 is connected to the control handle via a second shaft. The second shaft can be a wire control tube 220 or a wire. There can be multiple wires, each corresponding to a locking wire 33. For example, the locking wire 33 and the second shaft can be an integral structure. In this embodiment and the accompanying drawings, the second shaft is exemplified by a wire control tube.

[0156] The relative movement of the inner core 210 and the inner sheath 230 enables the relative movement of the locking seat 31 and the locking lever 32, thereby changing the constraint state of the locking wire 33. The state of the locking wire 33 can affect the movement process of the implant 100, especially during the release of the implant 100. The locking wire 33 enables the phased release of the implant 100. Furthermore, the mutual movement of the various tubes provides a structural basis for the full release and full retraction of the implant 100, thereby providing a more controllable interventional treatment process, improving treatment effectiveness and patient experience. When the expanded implant 100 (fully expanded but still connected to the locking wire 33) needs to be retrieved, the aforementioned sliding locking mechanism is unlocked. The second handle 42 slides relative to the first handle 41, enabling the implant 100 to be quickly retracted and housed inside the outer sheath 240.

[0157] In one embodiment, the lock seat has one or more grooves along its circumference, and the extended end has a protrusion structure along its circumference that matches the number and structure of the grooves in the lock seat. The locking wire passes through the artificial implant and is converged through the grooves and protrusion structure of the lock seat. The wire control mechanism includes a lock seat, a locking wire, and a protrusion structure that matches the structure of the lock seat.

[0158] Referring to one embodiment, the lock base 31 is provided with a lock hole that mates with the lock rod 32. In the locked state, the lock rod 32 is inserted into the lock hole and restricts the range of motion of the lock wire 33. Referring to one embodiment, the lock rod 32 moves with the inner core 210 and has the following positions:

[0159] Lock position (refer to Figure 9), lock rod 32 is inserted into the lock hole to restrain lock wire 33;

[0160] Release position (refer to Figure 10), the locking lever 32 disengages from the keyhole to release the locking cable 33.

[0161] In one embodiment, the catheter assembly 200 further includes a wire control tube 220 movably sleeved outside the inner core 210. One end of the locking wire 33 is a driving end and connected to the wire control tube 220, and the other end of the locking wire is a working end. When the implant is in the loaded state, the working end passes around the implant 100 and engages with the locking rod 32. There are multiple locking wires 33.

[0162] As shown in Figure 10, in one embodiment, the locking suture 33 has a second imaging marker 331. The second imaging marker 331 is located at the distal end of the locking suture 33 and is made of imaging-sensitive metals such as platinum-iridium alloy or gold. This facilitates intraoperative observation of the positional relationship between the locking suture 33 and the artificial implant 100, the locking seat 31, and the locking rod 32, thereby enabling precise release and retrieval operations. The second imaging marker 331 can be a single imaging point, continuously distributed at the distal end of the locking suture, or distributed along the entire locking suture. The second imaging marker 331 is connected to the locking suture 33 through processes such as bonding, sewing, weaving, and riveting. The second imaging marker 331 has a solid or hollow structure and can have different shapes depending on the connection process, such as ring-shaped, filament-shaped, circular, or square.

[0163] In interventional procedures and in vitro simulations, such as during interventional delivery, the rotational locking mechanism remains locked, with the outer sheath 240 encasing the implant 100 and the wire control mechanism until delivery to the surgical site, thus improving the safety of interventional delivery. During implant registration and release, the rotational locking mechanism is unlocked, and the first handle 41 is operated to move the outer sheath 240 relative to other catheter components to control the release of the implant. After successful retrieval or release of the implant, the sliding locking mechanism is unlocked, and the second handle slides proximally relative to the first handle, quickly retracting the implant and / or the wire control mechanism into the outer sheath before withdrawing it from the body.

[0164] As shown in Figure 4, the control of the catheter assembly and the corresponding drive mechanism is as follows:

[0165] The first support body 410 has a first guide groove 4102, and the second support body 420 has a second guide groove 4212. The distal end of the first support body 410 is fixed with a first extension sleeve 418, and the first support 419 is fixed inside the first extension sleeve 418. The first base 491 is slidably installed in the first guide groove 4102 of the first support body 410, and the first drive sleeve 481 is rotatably sleeved outside the first support body 410 and threadedly engaged with the first base 491. The proximal end of the second support body 420 is fixed with a second extension sleeve 427, and the distal end of the second support body 420 is fixed with a second support 428. The second base 492 and the third base 493 are slidably installed in the second guide groove of the second support body 420, and the second drive sleeve 482 and the third drive sleeve 483 are rotatably sleeved on the second support body 420 and threadedly engaged with the second base 492 and the third base 493, respectively.

[0166] The sheath 250 is fixed to the first support 419 inside the first extension sleeve 418, the outer sheath tube 240 is fixedly connected to the first base 491, the inner sheath tube 230 is fixedly connected to the second support 428, the wire control tube 220 is sealed through the second support 428 and fixedly connected to the second base 492, and the inner core 210 is fixedly connected to the third base 493.

[0167] In one embodiment, the control handle 400 is provided with an exhaust structure (e.g., a one-way valve). Specifically, the first support 419 is provided with a first exhaust structure 4191, and the second handle 42 is provided with a second exhaust structure 4291. In the figure, the second extension sleeve 427 is provided with a third support 429, the second exhaust structure 4291 is provided on the third support 429, and the third support 429 is connected to the second support 428 through an exhaust pipe 470, which passes through the second support body 420.

[0168] Specifically, the first exhaust structure is used to exhaust the gas between the sheath and the outer sheath tube, and the second exhaust structure is used to exhaust the gas between the outer sheath tube and the inner sheath tube, the inner sheath tube and the wire control tube, and the wire control tube and the inner core.

[0169] Referring to Figures 3 and 12-21, in one embodiment, two support rods 450 are arranged side by side with positioning teeth 4502 on their opposing sides. The support component in the second handle 42 includes a second support body 420, which has guide holes 4222 into which the two support rods 450 extend. The second handle 42 is also provided with a sliding locking mechanism 430 that cooperates with the positioning teeth 4502 to limit the relative position of the first handle 41 and the second handle 42. As shown in Figure 14, in the unlocked state, the sliding locking mechanism 430 allows the second handle 42 to slide relative to the first handle 41 along the support rods 450; while as shown in Figure 13, in the locked state, the position of the second handle 42 relative to the first handle 41 is fixed.

[0170] The strut serves as a connecting component between the second handle and the first handle, and is also equipped with positioning teeth to cooperate with the sliding locking mechanism to control the position of the second handle relative to the first handle, thereby satisfying the operation of the control handle and simplifying the structure of the control handle.

[0171] For ease of description, in the following embodiments, the top side and bottom side are referenced to the axis of the radial distance control handle, with the side farther away being the top side.

[0172] The sliding locking mechanism 430 includes a locking element 431, an elastic element 432, and an operating button 433. The locking element 431 is movably mounted on the second support 420 and has a locking position that engages with the positioning teeth 4502 and an unlocking position that disengages from the positioning teeth 4502. The elastic element 432 (e.g., a spring) acts between the locking element 431 and the second support 420, driving the locking element 431 towards the locking position. The operating button 433 acts on the locking element 431, driving the locking element 431 towards the unlocking position. Specifically, the unlocking and locking operations are as follows: a force is applied to the operating button 433, compressing the elastic element 432 and driving the locking element 431 to switch to the unlocking position; releasing the operating button 433 resets the elastic element 432, causing it to switch to the locking position.

[0173] In one embodiment, the locking member 431 and the operating button 433 slide radially. The locking member 431 has a mounting hole 4311, which is surrounded by multiple inner walls formed by slots inside the locking member 431. Corresponding to each inner wall, the mounting hole has multiple side walls, namely a top side wall, a side wall, and a bottom side wall. The locking member 4311 is slidably fitted onto the support rod 450 through the mounting hole 4311. There is a movable gap 4312 between the mounting hole 4311 and the support rod 450 in the sliding direction perpendicular to the support rod 450 (i.e., the sliding direction of the locking member 431). The locking member 431 moves along the movable gap 4312 during the switching between the unlocking and locking positions. Specifically, the movable gap 4312 is set such that the size of the mounting hole 4311 in the radial sliding direction of the locking member 431 is larger than the thickness of the support rod 450. Referring to Figures 12 to 15, in terms of assembly, the locking element 431 is sleeved on the support rod 450, which restricts the locking element 431 from detaching from the second support body 420. By utilizing different installation directions and the interaction between the components, the additional limiting structure is eliminated, the component structure is simplified, and assembly is convenient.

[0174] In one embodiment, one sidewall of the mounting hole 4311 faces the positioning tooth 4502, and this sidewall is provided with an engaging portion 4313 that mates with the positioning tooth 4502. The engaging portion 4313 is a tooth structure that mates with the positioning tooth 4502. Considering the movement direction of the locking member 431, the locking member 431 moves radially outward towards the locking position and radially inward towards the unlocking position. Therefore, the engaging portion 4313 is located on the bottom sidewall of the mounting hole 4311. The positioning tooth 4502 has a trapezoidal cross-sectional shape.

[0175] In one embodiment, the number of positioning teeth 4502, in conjunction with the operation of the control handle, is as follows:

[0176] The number of positioning teeth 4502 is one, which is used to keep the second handle at the position where the distance between it and the first handle is the farthest (i.e., the second extreme position below);

[0177] The positioning teeth 4502 are multiple and spaced apart along the axial direction, which can define the second handle in multiple positions for adjusting the position of the artificial implant in the body, or for facilitating precise control of the artificial implant during retrieval.

[0178] The sliding locking mechanism 430 is configured in two sets, each acting on a corresponding support rod 450. The operating buttons 433 in the two sets are arranged radially opposite to each other along the second handle 42 and facing opposite directions. A backing rib 4201 is fixed inside the second support body 420, and the elastic element 432 is compressed between the backing rib 4201 and the locking element 431.

[0179] The control handle 400 has an installation channel 403 that runs through the first support body 410 along the axial direction. The abutment ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form corresponding interval areas 4202, through which the installation channel 403 extends.

[0180] In one embodiment, the locking member 431 has a positioning seat 4315 on the side facing the elastic member 432, and the elastic member 432 is inserted into or sleeved onto the positioning seat 4315. In the illustration, the elastic member 432 is a spring, and the positioning seat 4315 has a receiving cavity to accommodate the spring portion. After assembly, the elastic member 432 and the locking member 431 are blocked by the support rod 450 and will not disengage from the second support body 420. Two retaining plates 4203 are protruding from the abutment rib 4201 and spaced apart axially. The space between the two retaining plates 4203 forms an installation area that adapts to the positioning seat 4315, restricts the axial movement of the locking member 431, and serves as a guide for the movement of the locking member 431.

[0181] In one embodiment, the strut 450 is a metal strip with a strip-shaped and approximately rectangular cross-section along the radial direction of the control handle, and the extension direction (length direction) of the metal strip is perpendicular to the spacing direction of the two struts 450.

[0182] In one embodiment, the strut 450 includes a support bar 452 and a rack 453 with positioning teeth 4502, as shown in FIG11. The support bar 452 has a mounting groove 4521 for mounting the rack 453. The rack 453 and the support bar 452 can be connected by embedding or fixing (e.g., bonding or welding). The mounting groove 4521 is open to the bottom and its extension range includes the sliding stroke of the second handle 42 relative to the first handle 41.

[0183] In one embodiment, the relationship between the positioning tooth 4502 and the bottom side of the support bar 452 is as follows:

[0184] The positioning tooth 4502 protrudes from the bottom side of the support bar 452;

[0185] Alternatively, the positioning teeth 4502 may be flush with the bottom side of the support bar 452;

[0186] Or the positioning tooth 4502 is lower than the bottom side of the support bar 452.

[0187] In one embodiment, the distal portion of the second support 420 is a second connecting seat 422, which includes two partitions 4221 and a transition portion 4223 connecting the two partitions 4221.

[0188] The transition portion 4223 is a shell structure with a semi-cylindrical surface. The second support body 420 also includes a second half shell 425 that is fastened and fixed to the transition portion 4223 and forms a cylinder. The sliding locking mechanism 430 is located in the area enclosed by the transition portion 4223 and the second half shell 425, and only a part of the operating button 433 is exposed for operation by the operator.

[0189] In one embodiment, the operating button 433 and the locking member 431 are engaged and fixed together, with a locking post on one of them and a locking hole on the other that engages with the locking post. For example, as shown in the figure, the locking post protrudes from the operating button 433; the locking hole is located on the locking member 431 and is tightly engaged with the locking post. There are two locking posts.

[0190] Referring to Figure 16, in one embodiment, the second support 420 further includes a retainer 426 that engages between the second connecting seat 422 and the second half-shell 425. The retainer 426 has an open slot 4261 for exposing the operation button 433. The retainer 426 surrounds the circumference of the operation button 433 and fills the gap between the operation button 433 and the second support 420 and the second half-shell 425.

[0191] The open slot 4261 is circumferentially closed, and the wall of the open slot extends along the movement direction of the operating button 433, providing movement guidance for the operating button 433.

[0192] Referring to Figures 2 and 18-23, the rotary locking mechanism 460 includes a first tube 461, a second tube 462, and a locking member 463. It should be noted that the first tube 461 and the second tube 462 are not part of the conduit assembly 200. The first tube 461 is fixed to a support body, with the first support body 410 shown as an example. A portion of the installation channel 403 extends through the interior of the first tube 461; that is, the first tube 461 has a hollow structure that allows partial or complete passage of the conduit assembly 200.

[0193] The second pipe fitting 462 is rotatably sleeved on the outer periphery of the first pipe fitting 461. A portion of the second pipe fitting 462 is a working section 4621 that extends into the rotating component 480. The outer wall of the working section 4621 has a protrusion 4622.

[0194] The locking member 463 is located within the radial gap between the working section 4621 and the rotating member 480, and is configured to slide radially along the rotating member 480 and act on the inner wall of the rotating member 480. During rotation, the second tube 462 moves by pressing against the locking member 463 via the protrusion 4622, thereby locking the rotating member 480 accordingly, or the protrusion 4622 releases the pressure on the locking member 463 to release the locking of the rotating member 480. The protrusion direction of the protrusion 4622 includes at least the radial direction.

[0195] As shown in Figure 20, in the unlocked position, the locking member 463 and the inner wall of the rotating component 480 have a movable gap, allowing the rotating component 480 to rotate easily under manual force. As shown in Figure 21, when the second tube 462 rotates around the dotted line to the locked position, the locking member 463 moves in the direction of the arrow and abuts against the rotating component 480, generating a sufficiently large force (e.g., static friction) between them, thereby restricting the rotation of the rotating component 480. This device structure can lock the rotating component 480 to any position, which is beneficial for the control of artificial implants. Compared with existing locking structures, it improves the operating accuracy of the control handle, and the locking operation is completed in one step, simplifying the operation steps. In addition, the locking member is installed in the radial gap between the working section and the rotating component, making the appearance of the control handle simple, and the overall shape and structure are easy to grip and operate, effectively utilizing space and making the structure of the control handle more compact.

[0196] In this embodiment, the rotation locking mechanism 460 further includes an operating component 464, which drives the second pipe 462 to rotate. The operating component 464 is movably mounted on the first support 410 and can be coupled to the second pipe 462 as follows:

[0197] a. Separate connection;

[0198] b. One-piece molding, for example, the second pipe 462 and the operating component 464 are integrally molded, one part of the second pipe 462 along the axial direction is the working section 4621, and the other part is connected to the operating component 464;

[0199] c. They are independent of each other, but they are linked and coordinated with each other through transmission components.

[0200] Among them, the second pipe fitting 462 has the following characteristics:

[0201] In the locked position, the protrusion 4622 abuts against the locking member 463 and acts on the rotating member 480, generating a pressing force against it;

[0202] In the release position, the protrusion 4622 and the locking member 463 release the clamping force.

[0203] As shown in Figures 17 to 23, in one embodiment, the sidewalls of the first support 410 and the first pipe 461 are partially opened on the same radial side to form an installation port 4611. The installation port 4611 is connected to the installation channel 403 to facilitate the installation of the conduit assembly 200 and the base.

[0204] In one embodiment, the sidewall of the second pipe fitting 462 is open to the radial direction, and the open position is offset from the open position of the first pipe fitting 461 in the circumferential direction. The openness of one side of the second pipe fitting 462 allows its working section 4621 to have a certain degree of deformation capability in the radial direction. For example, when locked, the inner wall of the working section 4621 abuts against the outer wall of the first pipe fitting 461, and the working section 4621 itself is subjected to forces in both the radial inner and outer directions, thereby restricting the rotation of the second pipe fitting 462. When unlocking, a large driving force needs to be applied to the operating component to avoid accidental unlocking and improve safety.

[0205] The circumferential misalignment of the open positions of the second pipe fitting 462 and the first pipe fitting 461 is understood as follows: taking the unlocking position in Figure 20 as an example, during the rotation of the second pipe fitting 462, the open port 4623 of the second pipe fitting 462 does not coincide with the installation port 4611.

[0206] Referring again to Figure 18, in one embodiment, the first support 410 includes a first body 411 and a first connecting seat 412. The first body 411 is columnar and extends axially along the control handle. A first tube 461 is located on the proximal side of the first body 411. The first connecting seat 412 is fixed to the proximal end of the first body 411 and has a radial gap with the first tube 461. The radial position of the second tube 462 is located within the radial gap. The first connecting seat 412 is generally a shell structure with a semi-cylindrical surface. The first support 410 also includes a first half-shell 414 that is fastened and fixed to the first connecting seat 412 and forms a cylinder. The first half-shell 414 has a clearance window 4181, through which the operating component 464 is exposed. The operating component 464 is provided with an anti-slip part 4641 and a mark 4642 for indicating locking and unlocking.

[0207] The locking mechanism is configured as follows:

[0208] As shown in Figure 22, in one embodiment, the first connecting seat 412 has a radially through guide groove 4121. The locking member includes a first locking block 4631 that is radially slidably disposed within the guide groove 4121, and a protrusion 4622 on the second tube 462 abuts against the radially inner side of the first locking block 4631. The outer contour of the working section 4621 of the second tube 462 is circular, and the protrusion 4622 extends along the locking rotation direction (hereinafter referred to as the first direction), with the height of the outer surface of the protrusion 4622 gradually increasing along the first direction. The inner wall of the locking member is an arc surface that matches the outer contour of the protrusion 4622.

[0209] Based on the mutually cooperating shape and structure of the locking member 463 and the protrusion 4622, the groove wall of the guide groove 4121 is provided with a registration structure that cooperates with the first locking block 4631. This registration structure prevents incorrect installation of the first locking block 4631 and positions the first locking block 4631 relative to the guide groove 4121. The registration structure includes:

[0210] The positioning groove 4122 is disposed on either the groove wall of the guide groove 4121 or the first locking block 4631;

[0211] The positioning block 4632 is disposed on the groove wall of the guide groove 4121 or on the other of the first locking block 4631 and cooperates with the positioning groove 4122. The positioning groove 4122 is a flared structure.

[0212] As shown in Figure 21, in another embodiment, the locking element includes a first locking element and a second locking element 4635. The first locking element is slidably fitted into the first connecting seat 412, such as the first locking block 4631 in the aforementioned embodiment. The second locking element 4635 is radially engaged with the first connecting seat 412. The first locking element and the second locking element 4635 move synchronously in opposite directions, acting on different radial inner walls of the same rotating component 480, thereby improving the locking strength.

[0213] The second locking element 4635 is semi-circular and has a guide structure that cooperates with the first support 410.

[0214] As shown in Figure 21, the guide structure includes:

[0215] The first slider 4633 is disposed on either the first connecting seat 412 or the second locking member 4635;

[0216] The first slide groove 4123 is disposed in the other of the first connecting seat 412 or the second locking member 4635, and cooperates with the first slider 4633.

[0217] In another embodiment, the guide structure further includes:

[0218] The second slide 4101 is disposed on the first main body 411;

[0219] The second slider 4639 is disposed on the second locking member 4635 and cooperates with the second slide groove 4101.

[0220] Referring again to Figures 20 and 21, in one embodiment, the first locking member and the second locking member 4635 are axially aligned and located on opposite radial sides of the second tube 462. In another embodiment, the locking members 463 include a plurality of locking members arranged axially, for example, multiple locking members acting at different axial positions of the same rotating component.

[0221] An anti-slip pad 4643 is embedded at the position where the locking member 463 mates with the rotating component 480. As mentioned above, both the first locking block 4631 and the second locking member 4635 are fitted with anti-slip pads 4643, as shown in Figure 18. The first locking block 4631 and the second locking member 4635 are made of hard material and can slide stably after being adapted to the first connecting seat 412. The anti-slip pad 4643 is made of soft material with a high coefficient of friction and a certain degree of deformation, such as rubber. When locked, the anti-slip pad 4643 is pressed against the inner wall of the rotating component 480, thereby increasing the static friction.

[0222] The second locking member 4635 is installed in the gap between the first connecting seat 412 and the first half shell 414, and the second locking member 4635 can move in the radial direction through the aforementioned guide structure, so that at least the second locking member 4635 and the inner wall of the rotating member 480 are always kept in a gap, so that the rotating member 480 can rotate smoothly in the unlocked position.

[0223] The inner wall of the second locking member 4635 has a radially undulating structure, which includes an arc surface 4638 (centered on the axis of the control handle) and a relief area 4637 that is radially recessed in the unlocked position to avoid the protrusion 4622. As shown in Figure 20, in the unlocked position, a section of the radially raised part of the protrusion 4622 is located within the relief area 4637. As shown in Figure 21, in the locked position, this section abuts against the arc surface 4638 and drives the second locking member 4635 to slide radially outward.

[0224] In one embodiment, the first connecting seat 412 has a blocking portion 4124 that abuts against the operating member 464 to limit its rotation range. In the figure, there are two blocking portions 4124 and they are sheet-like structures. The operating member 464 abuts against one of the blocking portions 4124 in the locked position and the unlocked position, respectively.

[0225] In one embodiment, a portion of the first support 410 radially extends to form a first guide groove 4102. A base (e.g., a first base 491) is slidably disposed within the first guide groove 4102. The base is used to connect a controlled component (e.g., a conduit assembly 200). The rotating component 480 is a drive sleeve, which is rotatably sleeved on the outer periphery of the first support 410. The inner wall of the drive sleeve is threadedly engaged with the base. Thus, the aforementioned anti-slip pad 4643 can better adapt to the threaded structure of the drive sleeve.

[0226] Regarding the rotary locking mechanism, the rotary locking mechanism is independent of the number of handles. For example, control handle 400 includes one handle on which the rotary locking mechanism is provided.

[0227] In one embodiment, two connecting sleeves 440 are fixedly connected to the proximal part of the first support body 410, and the distal part of each support rod 450 is fixedly inserted into the corresponding connecting sleeve 440. The two are fixed by snap-fit ​​connection or by fasteners.

[0228] The supporting component of the second handle 42 includes a second support body 420. The distal part of the second support body 420 includes two partitions 4221 arranged axially. Each partition 4221 has a guide hole 4222. The second support body 420 has a third sliding groove 4211 extending axially on both radially opposite sides. Each strut 450 passes through the corresponding guide hole 4222 and is inserted into the corresponding third sliding groove 4211. The second handle 42 slides relative to the first handle 41 along the two struts 450 and has two extreme positions close to / away from the first handle 41. The first extreme position is as shown in Figure 2, where the second handle 42 is close to the first handle 41, and the second extreme position is as shown in Figure 3, where the second handle 42 is away from the first handle 41.

[0229] The strut is rod-shaped, which is easy to process and has a lower processing cost; and it has a wider range of material options, such as hard metal, which improves the structural strength of the support component of the first handle and improves the connection stability between the first handle and the second handle, that is, the strut is not easy to bend or break when the second handle is away from the first handle.

[0230] In addition, to ensure the sliding stability of the second handle, two support rods are used. Furthermore, given the structural shape of the support rods, their cross-sectional shape is small, occupying less space and making them easier to arrange within the space of the second handle.

[0231] The control handle 400 has an axially extending mounting channel 403 through which the first support 410 and the second support 420 pass, allowing the conduit assembly 200 to pass. The first support 410 includes a first body 411 and a first connecting seat 412. The first body 411 is cylindrical and extends axially. The first connecting seat 412 is fixed to the proximal end of the first body 411, and two connecting sleeves 440 are fixed to the first connecting seat 412 and located on both sides radially of the mounting channel 403. Specifically, the connecting sleeves 440 are integrally formed with the first body 411 and are open at their proximal ends to allow the insertion of the support rod 450.

[0232] The connection between strut 450 and connecting sleeve 440 is as follows:

[0233] As shown in Figures 11 and 23, the side wall (radial outer side) of the connecting sleeve 440 and the far end of the support rod 450 are provided with positioning holes corresponding to each other, and are fixedly connected by a connector 442 passing through the positioning hole. For example, the connector 442 is a screw, and the support rod 450 is provided with a threaded hole that mates with the screw.

[0234] In one embodiment, the first connecting seat 412 is generally a shell structure with a semi-cylindrical surface, wherein the shell structure serves as the outer shell and is available for gripping. The first support body 410 also includes a first half-shell 414 that is fastened and fixed to the first connecting seat 412 and forms a cylinder with the shell structure. A connecting sleeve 440 is located at the junction of the first connecting seat 412 and the first half-shell 414, and the outer wall of the connecting sleeve 440 is provided with a buckle 415 that mates with the first half-shell 414.

[0235] In a preferred embodiment, the first half-shell 414 is installed radially, and the inner wall of the first half-shell 414 is provided with a limiting rib 416 that abuts against the connecting sleeve 440 to restrict the axial movement of the first half-shell 414. Specifically, after the first half-shell 414 is assembled, the limiting rib 416 abuts against one end face of the buckle 415 located on the connecting sleeve 440 along the axial direction of the control handle.

[0236] Part of the structure of the first support 410 also serves as part of the outer shell, saving manufacturing costs and simplifying the connection with the outer shell.

[0237] In one embodiment, the first connecting seat 412 is disposed on the side opposite to the opening of the first guide groove 4102, and the line connecting the two connecting sleeves 440 is arranged at a 90-degree angle to the direction of the opening.

[0238] As shown in Figures 12 to 24, in one embodiment, the support rod 450 is a metal strip. The metal strip has a strip-shaped radial section along the control handle, and its extension direction (i.e., the length direction) on this section is perpendicular to the spacing direction of the two support rods 450.

[0239] The second support 420 includes:

[0240] The second body is columnar and extends axially, and the third groove 4211 is located on the side of the second body opposite to the mounting channel 403.

[0241] The second connecting seat 422 includes two partitions 4221 and a transition portion 4223 connecting the two partitions 4221, wherein one partition 4221 is fixed to the far end of the second body.

[0242] The third connecting seat 423 is fixed to the proximal end of the second body.

[0243] The third groove 4211 is located on the back of the second main body, facilitating observation of the assembly of the support rod 450. Furthermore, given that the support rod 450 is strip-shaped, it reduces the space occupied by the second main body, ensuring its structural strength. The second support 428 is installed inside the second connecting seat 422. The second main body has a groove 4213 forming a channel. The proximal partition (i.e., the second partition 4221b hereinafter) has a clearance hole 4226. The exhaust pipe 470 extends from the second support 428 after connecting to the conduit assembly, passes through the open side of the transition portion 4223, and then through the clearance hole 4226 and the groove 4213 until it connects to the third support 429. The groove 4213 is located on the outer wall of the second guide groove 4212.

[0244] Referring again to Figure 12, in one embodiment, the two partitions 4221 include a first partition 4221a at the distal end and a second partition 4221b at the proximal end. A cover plate 424 is fastened to the distal side of the first partition 4221a. The cover plate 424 has a clearance area 4241 corresponding to the position of the installation channel 403 and the guide hole 4222. The transition portion 4223 between the two partitions 4221 is a shell structure with a semi-cylindrical surface. The second support body 420 also includes a second half-shell 425 that is fastened and fixed to the transition portion 4223 and forms a cylinder. The cover plate 424 is fastened and fixed to the first partition 4221a and the second half-shell 425.

[0245] The distal end of the first partition 4221a is provided with a radially extending positioning rib 4225, and the cover plate 424 is provided with a positioning groove 4242 that mates with the positioning rib 4225. The two partitions 4221 extend from their respective mounting channel positions along the first radial direction X to their own edges, and the cover plate 424 extends from its mounting channel positions along the second radial direction Y, which is opposite to the first radial direction X, to its own edges, forming the positioning groove 4242.

[0246] In one embodiment, the proximal portion of the third groove 4211 is a terminal section extending to the outer periphery of the third connecting seat 423, and the groove wall of the terminal section and the support rod 450 are provided with a mutually engaging engagement structure. Specifically, the engagement structure includes:

[0247] The locking block 4231 protrudes from the groove wall of the third sliding groove 4211;

[0248] A slot 4501 is disposed on the support rod 450 and engages with the locking block 4231. When the second handle 42 is in the first extreme position, the locking block 4231 and the slot 4501 engage with each other, meaning the slot 4501 is located near the proximal end of the support rod 450. This engaging structure provides only a certain amount of damping. After the sliding locking mechanism is unlocked, applying a certain external force to the second handle will release the engagement between the engaging structures. This engaging structure prevents the second handle from sliding due to accidental unlocking of the sliding locking mechanism by the operator, thus improving safety.

[0249] In one embodiment, the proximal end of the support rod 450 is provided with an anti-detachment component. When the second handle slides to its limit position relative to the first handle (i.e., the second limit position), the anti-detachment component is blocked by the partition. The anti-detachment component can be integrally formed with the support rod 450 or fixed separately. For example, the anti-detachment component is a screw, wherein the screw includes a threaded rod screwed into the support rod 450 and a nut protruding from the upper surface of the support rod 450. When the second handle 42 is in the second limit position, the nut abuts against the end face of the second partition 4221b. During assembly, the support rod 450 is first inserted through the second partition 4221b, and then the anti-detachment component is installed.

[0250] In the delivery system of this application, the strut serves as a connecting component between the second handle and the first handle, and also improves the structural strength of the control handle. It works in conjunction with the sliding locking mechanism to maintain the length of the control handle and meet operational requirements, such as rapid retraction of the implant and precise control of the implant during retrieval.

[0251] This application also provides a method for releasing an artificial implant 100 based on in vitro simulation, implemented using the interventional system of the artificial implant 100, the method for releasing the artificial implant 100 comprising:

[0252] Provide artificial implants;

[0253] The artificial implant 100 with the first imaging mark 332 is loaded into the intervention delivery system with the reference mark 241, and the circumferential relative position of the first imaging mark 332 and the reference mark 241 is adjusted according to the preset angle.

[0254] During the release process, the overall circumferential position of the intervention delivery system is maintained so that the artificial implant 100 is in the preset matching posture.

[0255] Referring to Figure 31, when the control handle 400 controls the implant 100 to enter the target position, the catheter assembly 200 passes through multiple turns. When the catheter assembly is not bent, the first imaging mark 332 on the implant 100 at the junction has a circumferential relative position with the control handle. When the implant 100 reaches the target position, after passing through multiple turns and twists of the catheter assembly, the first imaging mark 332 on the implant 100 shows the position shown in Figure 31. That is, there is a relatively definite relationship between the control handle 400 and the circumferential position of the implant 100. When the implant 100 is loaded with a certain circumferential offset relative to the control handle 400, when the implant 100 reaches the target position, the position of its junction is aligned with the original valve junction.

[0256] Referring to Figure 32, when the first imaging mark 332 of the artificial heart valve on the far left is aligned with the reference mark 241 on the control handle, after the artificial heart valve is released, the connecting part 130 is not aligned with the original valve connecting part 140, but instead just blocks the coronary ostium. When the first imaging mark 332 on the artificial heart valve is rotated as shown by the arrow in the figure and has a preset angle with the reference mark 241 on the control handle, after the artificial heart valve is released, the connecting part 130 is aligned with the original valve connecting part 140, thus avoiding obstruction of the coronary ostium.

[0257] Referring to Figures 1a, 29, and 30, in the assembled state of the interventional system, the circumferential relative positions of the control handle 400, catheter assembly 200, and wire control mechanism remain unchanged. The artificial implant 100 is connected to the interventional system through the wire control mechanism. The locking wire 33 in the wire control mechanism passes through and wraps around the artificial implant 100. Under the pull of the locking wire 33, the circumferential position of the artificial implant 100 is also determined.

[0258] The artificial implant 100 has a first imaging mark 332. The circumferential position of the first imaging mark 332 is determined (refer to Figures 20 and 30, where the position indicated by arrow H in Figure 30 can be understood as the circumferential position of the first imaging mark 332). The circumferential relative position of the first imaging mark 332 and the reference mark 241 is adjusted according to a preset angle. When the circumferential position of the first imaging mark 332 remains unchanged, that is, when the circumferential position of the reference mark 241 is adjusted, a fixed scale can be set on the circumferential direction of the control handle 400. The origin of this scale corresponds to the circumferential position of the first imaging mark 332 on the artificial implant 100, that is, the position of the dotted line in Figures 29 and 30.

[0259] The control handle 400 is provided with a rotating component 260. The rotating component 260 is provided with a reference mark 241 and a resting surface, or the rotating component 260 is provided with a reference mark 241 and multiple support parts. When the rotating component is rotated, the circumferential position of the reference mark 241 and the resting surface is changed at the same time, or the circumferential position of the reference mark 241 and multiple support parts is changed at the same time.

[0260] By rotating the reference mark 241 on the control handle 400, a preset angle is formed between it and the first developing mark 332 (see Figure 30). That is, the reference mark 241 corresponds to a certain value on the scale, which reflects the circumferential relative position of the first developing mark 332 and the reference mark 241.

[0261] The first imaging mark 332 indicates the circumferential position of the implant 100, while the reference mark 241 indicates the circumferential position of the control handle 400 in use. During the release process, the relative circumferential positions of the first imaging mark 332 and the reference mark 241 remain unchanged, while the position of the reference mark 241 of the control handle 400 remains unchanged. That is, the circumferential position of the reference mark 241 remains unchanged (that is, the resting surface or support corresponding to the reference mark remains unchanged in circumferential position). When the implant is released into place, the preset matching posture can be achieved.

[0262] The preset angle can be determined in several ways. For example, it can be achieved through simulation training. Specifically, in a simulated environment, the reference marker 241 and the first imaging marker 332 are placed in different circumferential positions, and the preset angle is obtained through multiple releases. Alternatively, it can be achieved through image comparison. After obtaining the preset angle from an image of a standard heart model, the difference between the images of the heart model to be released and the standard heart model is compared to obtain the preset angle.

[0263] In this application, after the artificial implant is loaded into the interventional system, there is a preset circumferential position between the artificial implant and the control handle of the interventional system. During the release process, the circumferential position of the control handle remains unchanged. After the artificial implant is released, there is no need to adjust the circumferential position to achieve alignment with the native valve. (Even if the artificial implant cannot be precisely aligned with the native valve at one time after release, it can be aligned with the native valve by making minor adjustments using existing technology.)

Claims

1. An interventional system for an artificial implant, having a distal and a proximal end, wherein the interventional system as a whole has an axial direction after straightening and corresponding radial and circumferential directions, characterized in that, The intervention system includes: A control handle having opposing top and bottom sides in the radial direction, the control handle having a top-facing use position, and the control handle having a reference mark for indicating the use position; A catheter assembly, the proximal end of which is connected to and controlled by the control handle; An artificial implant having a first imaging marker, the artificial implant being mounted at a preset angle to the distal end of the catheter assembly, the preset angle corresponding to the circumferential offset between the first imaging marker and the reference marker when the control handle is in use.

2. The interventional system for artificial implants as described in claim 1, characterized in that, The artificial implant is secured by a locking suture and is releasable and mounted on the catheter assembly.

3. The interventional system for artificial implants as described in claim 2, characterized in that, The locking thread has a second imaging marker, which has axial and radial displacement relative to the catheter assembly during the release of the implant. The second imaging marker has the largest radial displacement when the implant expands radially to its maximum extent.

4. The interventional system for artificial implants as described in claim 3, characterized in that, The artificial implant includes a stent and multiple leaflets connected to the stent. The stent has a connecting portion in the circumferential direction corresponding to the splicing parts of adjacent leaflets. The circumferential positions of the first imaging mark and the second imaging mark correspond to one of the connecting portions.

5. The interventional system for artificial implants as described in claim 3, characterized in that, The second imaging mark 331 is located at the far end of the locking wire.

6. The interventional system for artificial implants as described in claim 3, characterized in that, The second development mark is a development point or is continuously distributed at the far end of the lock wire or distributed along the entire lock wire.

7. The interventional system of artificial implants of claim 3, wherein, The second developing mark is connected to the locking thread through processes such as bonding, sewing, weaving, and riveting.

8. The interventional system for artificial implants as described in claim 1, characterized in that, The artificial implant is an artificial heart valve, which has an inflow end and an outflow end, including, The support is cylindrical and has a mesh structure; A skirt, which is sewn to the inlet end of the stent to form a blood flow channel with the stent; Multiple leaflets are sewn to the outflow end of the skirt. Each leaflet is located within the blood flow channel and cooperates with each other to control the interruption of blood flow. The leaflets include a fixed edge that connects to the skirt and fixes it to the support, and a free edge that cooperates with adjacent leaflets to control the blood flow channel. The artificial heart valve has a third imaging marker at a position near the inflow end.

9. The interventional system for artificial implants as described in claim 8, characterized in that, The farthest point of the leaflet fixing edge is connected to the support grid node.

10. The interventional system for artificial implants as described in claim 8, characterized in that, The third imaging marker is axially misaligned with the farthest endpoint of the leaflet fixing edge.

11. The interventional system for artificial implants as described in claim 8, characterized in that, The valve includes an inflow area, a valve area, and an outflow area. The inflow area consists of at least one row of circumferentially distributed diamond-shaped grids, with adjacent cells interconnected circumferentially to form interconnection points. The third imaging marker is located at the interconnection point.

12. The interventional system of artificial implants of claim 1, wherein, The control handle is held in use by its own shape or positioning device, wherein: The shape itself includes a resting surface or multiple support parts on the bottom side; The positioning device and the control handle are provided with a corresponding coupling structure.

13. The interventional system for artificial implants as described in claim 2, characterized in that, The control handle includes a first handle and a second handle that cooperate with each other, and the catheter assembly includes: The outer sheath is connected to the first handle at its proximal end and is used to cover the artificial implant at its distal end. The third shaft has its proximal end fixed to the second handle, and its distal end is connected to a lock seat with a lock hole. The second shaft is connected to the second handle at its proximal end, and the locking wire is connected to the distal end of the second shaft. The locking wire passes through the artificial implant and is connected to the locking seat to restrain or release the artificial implant. A first shaft, with its proximal end connected to the second handle, and a locking rod connected to its distal end to maintain the connection between the locking line and the locking seat.

14. The interventional system for artificial implants as described in claim 1, characterized in that, The control handle includes a support body, a base slidably mounted on the support body and used for pulling the locking wire, and a drive sleeve rotatably sleeved on the support body and threadedly driven with the base.

15. The interventional system for artificial implants as described in claim 14, characterized in that, The control handle further includes a rotation locking mechanism that restricts or allows rotation of the drive sleeve, the rotation locking mechanism comprising: The first pipe fitting is fixed to the support body; The second pipe fitting is rotatably sleeved on the outer periphery of the first pipe fitting. A portion of the second pipe fitting is a working section that extends into the drive sleeve. The outer wall of the working section has protrusions. A locking element is located within the radial gap between the working section and the drive sleeve, and is configured to slide radially along the drive sleeve and act on the inner wall of the drive sleeve. During the rotation of the second tube, the locking element moves via the protrusion and locks the drive sleeve accordingly.

Images