Interventional systems for artificial implants

Abstract

The present invention discloses an interventional system for an artificial implant, which has a relative distal end and a proximal end, and has an axial direction after being straightened as a whole, and a corresponding radial and circumferential direction. The interventional system comprises: a control handle, which has a relative top side and bottom side in the radial direction, and has a use state with the top side facing upward, and the control handle has a reference mark for indicating the use state; a catheter assembly, the proximal end of the catheter assembly is connected to and controlled by the control handle; an artificial implant, the artificial implant has a first development mark, and the artificial implant is loaded to the distal end of the catheter assembly according to a preset angle, and the preset angle corresponds to the circumferential offset amplitude between the first development mark and the reference mark when the control handle is in use. The interventional system can realize the rapid alignment and release of the artificial implant.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an interventional system for artificial implants. Background Art

[0002] In the transvascular technique, a loaded prosthetic valve is mounted on the end portion of a flexible catheter and advanced through the patient's blood vessels until the prosthetic valve reaches the implantation site. The prosthetic valve at the end of the catheter expands to its functional size at the site of the diseased native valve.

[0003] In interventional implantation of artificial valves, it is expected that the commissures of the implanted artificial heart valve can be aligned with the commissures of the native aortic valve to prevent the artificial valve leaflets from blocking coronary blood flow. In order to achieve this expectation, in the prior art, the circumferential position of the artificial heart valve is usually adjusted during the implantation process by rotating the artificial heart valve (for example, rotating the delivery system to drive the valve to rotate together) so that the commissures of the artificial heart valve are aligned with the commissures of the native valve.

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

[0005] Usually, the sheath of the delivery system is long, and the human blood vessels are usually tortuous. The force of rotating the delivery system at the handle cannot be well transmitted to the distal artificial heart valve. Rotating the handle to a certain degree does not mean that the artificial heart valve can also rotate to the corresponding degree. In addition to the reason that the sheath is too long, it is also affected by the sheath's own anti-kink degree, so the rotation effect is poor and difficult to control. In addition, when rotating the delivery system, blood clots may fall off, which brings certain risks. Summary of the invention

[0006] The present application provides an interventional system for an artificial implant, which enables the artificial implant to meet a specific circumferential preset angle when loaded, so that it can be aligned with the native valve without adjusting the circumferential position during the implantation process.

[0007] The present application provides an interventional system of an artificial implant, which has a distal end and a proximal end relative to each other. The interventional system as a whole has an axial direction after being straightened and corresponding radial and circumferential directions. The interventional system comprises:

[0008] A control handle, the control handle having a top side and a bottom side opposite to each other in a radial direction, the control handle having a use state with the top side facing upward, and the control handle having a reference mark for indicating the use state;

[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 developing mark is loaded to the distal end of the catheter assembly according to a preset angle, wherein the preset angle corresponds to the circumferential offset amplitude between the first developing mark and the reference mark when the control handle is in use.

[0011] Several optional methods are also provided below, but they are not intended to be additional limitations on the above-mentioned overall solution, but are merely further supplements or preferences. Under the premise that there are no technical or logical contradictions, each optional method can be combined with the above-mentioned overall solution separately, and multiple optional methods can also be combined.

[0012] Optionally, the artificial implant is bound by a locking wire and releasably loaded on the catheter assembly, the control handle includes a support body, a base slidably mounted on the support body and used to pull the locking wire, a drive sleeve rotatably sleeved on the support body and threadedly driven with the base, the control handle also includes a rotation locking mechanism for limiting or allowing the drive sleeve to rotate, and the rotation locking mechanism includes:

[0013] A first pipe member, fixed to the support body;

[0014] A second pipe member, the rotating sleeve of which is arranged on the outer periphery of the first pipe member, wherein a portion of the second pipe member is a working section extending into the driving sleeve, and an outer wall of the working section has a convex portion;

[0015] The locking piece is located in the radial gap between the working section and the driving sleeve, and is configured to be able to slide radially along the driving sleeve and act on the inner wall of the driving sleeve. During the rotation of the second pipe, the locking piece is pressed by the protrusion to move and lock the driving sleeve accordingly.

[0016] Optionally, the locking wire has a second visualization mark, and the second visualization mark has an axial displacement and a radial displacement relative to the catheter assembly during the release of the artificial implant. When the artificial implant radially expands to a maximum extent, the second visualization mark has a maximum radial displacement.

[0017] Optionally, the artificial implant includes a stent and a plurality of leaflets connected to the stent, the stent has a connection portion corresponding to the splicing position of adjacent leaflets in the circumferential direction, and the circumferential positions of the first developing mark and the second developing mark correspond to one of the connection portions.

[0018] Optionally, the artificial implant is an artificial heart valve, the artificial heart valve having an inflow end and an outflow end, comprising:

[0019] A bracket, which is cylindrical and has a grid structure;

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

[0021] A plurality of leaflets are sewn to the outflow end of the skirt, each leaflet is in the blood flow channel and cooperates with each other to control blood flow interruption, the leaflet includes a fixed edge connected to the skirt and fixed to the bracket, and a free edge that cooperates with adjacent leaflets to control the blood flow channel; the artificial heart valve is provided with a third developing mark at a position adjacent to the inflow end.

[0022] Optionally, the farthest end point of the leaflet fixing edge is connected to the stent grid node.

[0023] Optionally, the third imaging mark is axially offset from the most distal end point of the leaflet fixing edge.

[0024] Optionally, the valve includes an inflow area, a valve area, and an outflow area, the inflow area is composed of at least one row of circumferentially distributed rhombus cells, adjacent cells are circumferentially interconnected to form interconnection points, and the third development mark is located at the interconnection points.

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

[0026] The self shape includes a resting surface or a plurality of supporting parts on the bottom side;

[0027] A corresponding coupling structure is provided between the positioning device and the control handle.

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

[0029] An outer sheath, the proximal end of which is connected to the first handle and the distal end of which is used to cover the artificial implant;

[0030] A third shaft, the proximal end of which is fixed to the second handle, the distal end of which is connected to a lock seat, and the lock seat has a lock hole;

[0031] A second shaft, the proximal end of which is connected to the second handle, the locking wire is connected to the distal end of the second shaft, and the locking wire is connected to the locking seat after passing through the artificial implant to restrain or release the artificial implant;

[0032] The first shaft has a proximal end connected to the second handle, and a distal end of the first shaft is connected to a locking rod for maintaining the connection between the locking wire and the locking seat.

[0033] Optionally, the first handle includes a first support body and a support rod fixed to the first support body and further extending in the proximal direction, and the second handle includes a second support body slidably mounted on the support rod, and a sliding locking mechanism that acts on the support rod is also provided on the distal side of the second support body itself.

[0034] Optionally, the lock seat includes a guide portion, a reduced diameter portion and a connecting portion from the distal end to the proximal end, wherein the connecting portion is respectively 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 coupling area, and the distal end shape of the connecting portion converges and forms an expansion area on the outer periphery that is connected to the coupling area.

[0035] Optionally, there are multiple locking rods with different lengths, and in the release position, the proximal ends of all the locking rods are located in the guide holes of the guide part.

[0036] The present application also provides an artificial implant release method based on in vitro simulation, comprising:

[0037] Providing artificial prostheses;

[0038] Loading the artificial implant with the first developing mark onto the interventional delivery system with the reference mark, and adjusting the circumferential relative position of the first developing mark and the reference mark according to a preset angle;

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

[0040] The interventional system for artificial implants provided in the present application enables the artificial implant to meet a specific circumferential preset angle when loaded, so that it can be aligned with the native valve without adjusting the circumferential position during the implantation process. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] Figure 1a A structural diagram of a conveying system according to an embodiment of the present application;

[0042] Figure 1b This is a structural view of an artificial heart valve according to an embodiment of the present application;

[0043] Figure 2 for Figure 1a Structural view of the middle control handle;

[0044] Figure 3 for Figure 1a A schematic diagram of the structure in which the second handle in the middle control handle slides toward the proximal end relative to the first handle;

[0045] Figure 4 for Figure 2A cross-sectional view of the middle control handle along its own axis;

[0046] Figure 5 This is an exploded view of the second handle in the control handle of the present application;

[0047] Figure 6 for Figure 1a Enlarged view of part A in the middle;

[0048] Figure 7 A partial structural view of a lock rod and a lock seat in a wire control mechanism according to an embodiment of the present application when the lock rod and the lock seat cooperate with each other;

[0049] Figure 8 A cross-sectional view of a catheter assembly according to an embodiment of the present application;

[0050] Fig. 9 This is a schematic diagram of a state in which the distal end of the delivery system according to an embodiment of the present application releases the artificial implant and loosens the locking wire;

[0051] Fig.10 This is a schematic diagram of a state in which the distal end of the delivery system according to an embodiment of the present application releases the artificial implant and releases the locking wire;

[0052] Fig.11 An exploded view between the support rod and the first handle in a control handle according to an embodiment of the present application;

[0053] Fig.12 An exploded view of a sliding locking mechanism in a control handle according to an embodiment of the present application;

[0054] Fig.13 for Figure 4 Enlarged view of middle section B (slide lock mechanism in locked state);

[0055] Fig.14 for Figure 4 Enlarged view of middle section B (slide lock mechanism in unlocked state);

[0056] Fig.15 An exploded view of a second half shell and a second drive sleeve in a control handle according to an embodiment of the present application;

[0057] Fig.16 An exploded view of an operating button in a control handle according to an embodiment of the present application;

[0058] Fig.17 for Figure 2 An exploded view of the middle control handle between the rotating part and the support body;

[0059] Fig.18 for Fig.17 Exploded view of the middle locking piece and half shell;

[0060] Fig.19 A front view of a control handle according to an embodiment of the present application;

[0061] Fig. 20 for Fig.19 Cross-sectional view in the FF direction (locking device is in unlocked state);

[0062] Fig.21 for Fig.19 Cross-sectional view in the middle FF direction (locking device in locked state);

[0063] Fig. 22 This is a structural view of a locking member (first locking block) according to an embodiment of the present application;

[0064] Fig.23 A partial structural view of a control handle in an embodiment of the present application when the second handle is in a second extreme position;

[0065] Fig.24 A structural view of the engagement structure between the support rod and the slide groove in the control handle of one embodiment of the present application;

[0066] Fig.25 This is a schematic diagram of the structure of the lock seat in this application;

[0067] Fig.26 A schematic diagram of the lock seat in this application;

[0068] Fig. 27 for Fig.26 Schematic diagram of the E direction perspective;

[0069] Fig.28 for Fig. 27 GG cross-sectional diagram of the middle lock seat;

[0070] Fig.29 A schematic diagram of the position of the first developing mark and the reference mark aligned (only for principle illustration);

[0071] Fig.30 A schematic diagram of a position where a first developing mark and a reference mark have a preset angle (only for schematic illustration);

[0072] Fig.31 A schematic diagram of releasing an artificial implant through a control handle;

[0073] Fig.32 It is a schematic diagram of the position of the artificial implant after release when the first development mark and the reference mark are aligned and have an included angle.

[0074] In the figure: 100, artificial implant; 110, stent; 120, leaflet; 130, commissure; 140, native valve commissure; 150, free edge; 160, fixed edge; 161, the most distal end of the fixed edge; 170, diamond grid; 180, third imaging mark; 200, catheter assembly; 210, inner core; 220, wire control tube; 230, inner sheath; 240, outer sheath; 241, reference mark; 250, sheath;

[0075] 31, lock seat; 32, lock rod; 33, lock line; 331, second development mark; 332, first development mark; 311, guide part; 312, reduced diameter part; 313, connecting part; 314, wire hole; 315, lock hole; 316, guide hole; 317, combination area; 318, expansion area;

[0076] 400, control handle; 401, proximal end; 402, distal end; 403, installation channel;

[0077] 41, first handle; 410, first support body; 4101, second slide groove; 4102, first guide groove; 411, first body; 412, first connecting seat; 4121, guide groove; 4122, positioning groove; 4123, first slide groove; 4124, blocking part; 414, first half shell; 415, buckle; 416, limiting rib;

[0078] 418, first extension sleeve; 4181, avoidance window; 419, first support; 4191, first exhaust structure;

[0079] 42, second handle; 420, second support body; 4201, abutting rib; 4202, spacing area; 4203, clamping plate; 4211, third slide groove;

[0080] 422, second connecting seat; 4212, second guide groove; 4213, groove; 4221, partition; 4221a, first partition; 4221b, second partition; 4222, guide hole; 4223, transition part; 4225, positioning rib; 4226, avoidance hole;

[0081] 423, third connecting seat; 4231, card block;

[0082] 424, cover plate; 4241, avoidance area; 4242, positioning groove;

[0083] 425, second half shell; 426, card seat; 4261, open slot;

[0084] 427, second extension sleeve; 428, second support; 429, third support; 4291, second exhaust structure;

[0085] 430, sliding locking mechanism; 431, locking member; 4311, assembly hole; 4312, movable gap; 4313, meshing portion; 4315, alignment seat;

[0086] 432, elastic member; 433, operating button;

[0087] 440, connecting sleeve; 442, connecting piece;

[0088] 450, support rod; 4501, slot; 4502, positioning tooth;

[0089] 452, support bar; 453, rack; 4521, mounting groove;

[0090] 460, rotation locking mechanism; 461, first pipe; 4611, installation port;

[0091] 462, second pipe; 4621, working section; 4622, raised portion; 4623, open mouth;

[0092] 463, locking member; 4631, first locking block; 4632, positioning block; 4633, first slider; 4635, second locking member; 4637, avoidance area; 4638, arc surface; 4639, second slider

[0093] 464, operating part; 4641, anti-slip part; 4642, logo; 4643, anti-slip pad;

[0094] 470, exhaust pipe; 480, rotating component; 481, first drive sleeve; 482, second drive sleeve; 483, third drive sleeve;

[0095] 491, first base; 492, second base; 493, third base. DETAILED DESCRIPTION

[0096] See also Figure 1a~Figure 9 , Figure 29-Figure 30 The present application provides an interventional system of an artificial implant 100, having a distal end and a proximal end relative to each other, and the interventional system as a whole has an axial direction after being straightened and corresponding radial and circumferential directions (the axial, radial and circumferential directions refer to Fig.29 The intervention system includes:

[0097] A control handle 400, wherein the control handle 400 has a top side and a bottom side opposite to each other in a radial direction, and the control handle 400 has a use state with the top side facing upward, and the control handle 400 has a reference mark 241 for indicating the use state;

[0098] A catheter assembly 200, the proximal end of which is connected to and controlled by a control handle 400;

[0099] The artificial implant 100 has a first developing mark 332, and the artificial implant 100 is loaded to the distal end of the catheter assembly 200 according to a preset angle, and the preset angle corresponds to the circumferential offset amplitude between the first developing mark 332 and the reference mark 241 when the control handle 400 is in use.

[0100] The catheter assembly 200 in the interventional system has a certain length and can be bent. In the present application, when the axial, radial and circumferential directions are mentioned, it means that the control handle 400 and the catheter assembly 200 are in a state of being straightened.

[0101] The control handle 400 has a top side and a bottom side in the radial direction, and the top side and the bottom side are relative concepts, see Figure 1a As shown, when the control handle 400 is placed flat on a horizontal plane, the bottom side of the control handle 400 contacts the horizontal plane, and the top side is the top surface side.

[0102] The reference mark 241 on the control handle 400 is used to indicate the use state of the control handle 400. When in use, the control handle 400 keeps the top side facing upward, and the control handle 400 remains in the use state with the top side facing upward to release the artificial implant 100.

[0103] The control handle 400 remains in the use state with the top side facing upward, mainly to keep the control handle 400 from rotating in its circumferential direction, and the movement in other directions does not affect the release process.

[0104] The control handle 400 is kept in the use state by its own shape or the positioning device, wherein: the own shape includes a placing surface or a plurality of supporting parts on the bottom side; a corresponding coupling structure is provided between the positioning device and the control handle 400.

[0105] The reference mark 241 and the placing surface have a fixed positional relationship in the circumferential direction. For example, the reference mark 241 and the placing surface are respectively arranged on both sides of the radial direction of the control handle, that is, when the axial direction of the control handle is parallel to the horizontal plane, the reference mark 241 and the placing surface are respectively located at the top and bottom of the control handle, and when the reference mark 241 rotates around the circumference of the control handle 400, the placing surface also rotates synchronously by a corresponding angle. The positional relationship between the reference mark 241 and the support portion is the same as the positional relationship between the reference mark 241 and the placing surface.

[0106] Specifically, when a placing surface or multiple supporting parts are provided on the control handle 400, when in use, the placing surface or supporting parts are fixed on a certain supporting plane. The supporting plane can be provided by an object such as an operating table that is fixed in space and will not move arbitrarily. The placing surface or supporting parts on the control handle 400 cooperate with the supporting plane to prevent the control handle 400 from rotating in the circumferential direction.

[0107] The positioning device can enable the clamping device matched with the control handle 400 to limit the circumferential rotation of the control handle 400, or can enable the concave-convex structure matched with the surface of the control handle 400 to prevent the control handle 400 from rotating in the circumferential direction.

[0108] The artificial implant 100 has a first visual marker 332 , and the first visual marker 332 is used to indicate the circumferential position of the artificial implant 100 .

[0109] See also Fig.10 As shown, the lock wire 33 has a second developing mark 331. The second developing mark 331 has an axial displacement and a radial displacement relative to the catheter assembly 200 during the release process of the artificial implant 100. When the artificial implant 100 radially expands to the maximum extent, the second developing mark 331 has the maximum radial displacement. The movement trajectory of the lock wire 33 is completely different from the movement trajectory of the first developing mark 332 on the stent 110. The second developing mark 331 on the lock wire 33 is used to assist in determining the release form of the artificial implant 100 during the release process.

[0110] by Figure 1b , Figure 6 , Fig.32 Taking the artificial heart valve shown as an example, the artificial heart valve includes a cylindrical stent 110 with a grid structure, a skirt and multiple leaflets 120. The skirt is sewn to the bottom of the stent to form a blood flow channel with the stent; multiple leaflets 120 are sewn to the outflow end of the skirt, each leaflet is in the blood flow channel and cooperates with each other to control blood flow interruption, and the edge of the leaflet includes a fixed edge 160 connected to the skirt and fixed to the stent, and a free edge 150 that cooperates with other leaflets to control the blood flow channel. The farthest end point 161 of the leaflet fixed edge 160 is connected to the stent grid node.

[0111] The stent 110 has a connection portion 130 corresponding to the splicing position of adjacent leaflets 120 in the circumferential direction, and the circumferential position of the first imaging mark 332 and the second imaging mark 331 corresponds to one of the connection portions 130. Figure 6 In the figure, the circumferential positions of the first development mark 332 and the second development mark 331 correspond to one of the connecting parts 130. That is, there are three connecting parts 130, which are respectively 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 part 130 in the axial direction.

[0112] The circumferential position of the second developing mark 331 corresponds to the connection part 130, which means that when the artificial implant 100 is radially expanded to the maximum state, the second developing mark 331 is aligned with the connection part 130 in the axial direction. If the artificial implant 100 is not radially expanded to the maximum state, there is no aligned positional relationship between the second developing mark 331 and the first developing mark 332 and the connection part 130 at the splicing part of the leaflet 120.

[0113] The first developing mark 332 is at least two developing points, and the second developing mark 331 includes a plurality of developing points, the number of which corresponds to the number of the locking lines 33. Fig.10 As shown, there are three developing points as the second developing mark 331. For an artificial heart valve, there are three leaflets 120, and there are also three joints 130 at the joints of adjacent leaflets 120. The first developing points are at least two developing points, each of which is aligned axially with one of the joints 130 (that is, the line connecting the developing point and the joint 130 is coplanar with the axis), and two or more developing points are aligned axially with different joints 130. When the artificial implant 100 (such as a heart valve) is radially expanded to the maximum state, each developing point of the second developing mark 331 is aligned axially with one of the joints 130.

[0114] The artificial implant has an inflow end and an outflow end, and the artificial implant is provided with a third developing mark at a position adjacent to the inflow end. The artificial implant has a grid structure, and the third developing mark is arranged at a node of the grid, and in the axial direction, the distance between the third developing mark and the inflow end is 0.5 to 2 cell heights. After the artificial implant is implanted in the target position, the implantation depth of the artificial implant can be indicated by the third developing mark, and the implantation depth is the implantation position in the axial direction relative to the native valve.

[0115] The artificial heart valve includes an inflow area C, a valve area B, and an outflow area A. The fixed edge 160 and the free edge 150 of the valve leaflet are used as boundaries. The section from the most distal inflow end of the valve stent to the most distal end 161 of the valve leaflet fixed edge 160 is the inflow area C, the valve leaflet section is the valve area B, and the valve leaflet free edge 150 to the most proximal outflow end of the valve stent is the outflow area A. The inflow area is composed of at least one row of circumferentially distributed rhombus grids 170, and adjacent cells are interconnected circumferentially to form an interconnection point, and the third development mark is located at the interconnection point. The third development mark is axially misaligned with the most distal end of the valve leaflet fixed edge. In this embodiment, the inflow area is composed of a row of circumferentially distributed rhombus grids 170, and adjacent cells are interconnected circumferentially to form an interconnection point. The third development mark 180 is located at the interconnection point, that is, in the axial direction, the distance between the third development mark 180 and the inflow end is 0.5 cell (rhombus grid) height, which is about 4-9mm.

[0116] The delivery system of the artificial implant has a relative distal end 402 and a proximal end 401. The delivery system includes a control handle 400 and a catheter assembly 200 whose proximal end is connected to the control handle 400. The artificial implant 100 is connected to the distal end of the catheter assembly 200 and is 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, and each handle includes a support member and a driving mechanism arranged on the support member. The driving mechanism is a plurality of groups, each group is connected with a part of the catheter assembly, and is used to control the wire control mechanism located at the distal end of the catheter assembly to complete the expansion, release and recovery of the artificial implant. The supporting member is used to provide a base for the installation and movement of the driving mechanism and / or another handle and the structural support of the corresponding handle.

[0117] The support member in the first handle 41 includes a first support body 410 and two support rods 450 fixedly connected to the first support body 410 and extending toward the proximal end. The support member in the second handle 42 includes a second support body 420 slidably mounted on the support rods 450. Each support body is provided with a guide groove extending in the axial direction, and the driving mechanism includes a base that moves along the sliding direction and a driving sleeve that is rotatably mounted on the periphery of the corresponding support body. The driving sleeve and the base are threadedly driven, and some components in the catheter assembly are connected to the base and complete corresponding actions under the drive of the driving sleeve.

[0118] Each support body is provided with a rotation locking mechanism on the proximal side of its own guide groove, which can limit or allow the rotation of the drive sleeve. A sliding locking mechanism is also provided on the distal side of the second support body 420 itself, which acts with the support rod 450 to maintain the relative position with the first support body 410.

[0119] The catheter assembly 200 includes an outer sheath 240 and at least one shaft in order from the outside to the inside in radial direction, wherein one shaft refers to one or more shafts fixed to each other, for example, two relatively fixed pipes can also be regarded as one shaft. Figure 8 As shown, the catheter assembly 200 specifically includes an outer sheath 240, a third shaft (such as the inner sheath 230 described below), a second shaft (such as the wire-controlled tube 220 described below) and a first shaft (such as the inner core 210 described below).

[0120] See also Figure 4~Figure 10The 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 shaft is fixed to the second handle 42, the proximal end of the second shaft is movably connected to the second base 492 in the second handle 42, and the proximal end of the first shaft is movably connected to the proximal part of the second handle 42. The first shaft, the second shaft and the third shaft are all controlled by the second handle 42. When the sliding locking mechanism is unlocked, the second handle 42 can be relatively away from or close to the first handle 41, thereby realizing the rapid movement of the first shaft, the second shaft and the third shaft relative to the outer sheath 240.

[0121] In one embodiment, a first extension sleeve 418 is further fixed to the distal end of the first support body 410 , and the catheter assembly 200 further includes a sheath 250 which is sleeved on the outside of the outer sheath 240 and fixed to the first handle 41 at its proximal end.

[0122] 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 at the distal end of the locking seat 31, and the distal end of the wire control tube 220 is connected to a locking wire 33, which is passed through the artificial implant 100 and then tightened or loosened on 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 above-mentioned wire control mechanism.

[0123] See also Fig.25 , Fig.26 , Fig. 27 , Fig.28 As shown, the wire control mechanism of the artificial implant has a distal end and a proximal end relative to each other, and the wire control mechanism includes:

[0124] The lock seat 31 includes a guide portion 311, a reduced diameter portion 312 and a connecting portion 313 from the distal end to the proximal end, wherein the connecting portion 313 is respectively 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 bonding area 317, and the distal end of the connecting portion 313 is convergent in shape and forms an expansion area 318 in the outer periphery that is connected to the bonding area 317;

[0125] The locking rod 32 is slidably matched with the locking seat 31 and inserted into the locking hole 315 via the guide hole 316;

[0126] The locking wire 33 has a driving end at one end and extends toward the proximal end through the wire hole 314 , and a working end at the other end for passing through the artificial implant and then being coupled to the locking rod 32 .

[0127] The structure of the lock seat 31 in the prior art is shown in Figure 7As shown, the lock seat 31 includes a guide portion 311, a reduced diameter portion 312 and a connecting portion 313, wherein the connecting portion 313 is generally cylindrical, and is provided with a lock hole 315 and a wire hole 314. When the lock rod 32 is inserted into the lock hole 315 of the connecting portion 313 via the guide hole 316 in the guide portion 311, precise alignment is required. Since the sizes of the lock rod 32, the lock hole 315 and the guide hole 316 are all small, extremely high processing accuracy is required. At the same time, when the working end of the lock wire 33 is passed through the artificial implant, it is operated in the outer area of ​​the reduced diameter portion 312 (i.e., the bonding area 317), the operating space is small, and the line of sight is easily blocked.

[0128] In this application, the structure of the lock seat 31 is shown in Fig.25 , Fig.26 , Fig. 27 As shown, the distal end of the connecting portion 313 of the lock seat 31 converges and forms an expansion area 318 connected to the bonding area 317 on the periphery. The distal ends of the lock hole 315 and the wire hole 314 on the connecting portion 313 are exposed to the expansion area 318. The area range of the expansion area 318 is shown in FIG. Fig.26 As shown in the dotted box in FIG. 1 , it is an area surrounding the connecting portion 313 and having a triangular cross section. This area is an area where the lock wire 33 can be operated more than the bonding area 317 around the lock seat 31 in the prior art. Fig.28 As shown, the locking hole 315 and the wire hole 314 on the connecting portion 313 are both exposed in the expansion area 318. The locking wire 33 passes through the wire hole 314 and is connected to the artificial implant. The opening of the wire hole 314 is relatively large, and the locking wires 33 are not easily entangled. At the same time, the line of sight is better when passing through the artificial implant.

[0129] See also Fig.28 As shown, the opening of the locking hole 315 is relatively large, and the opening of the locking hole 315 is on an inclined surface. When the locking rod 32 is to be inserted into the locking hole 315, it is guided by the inclined surface and enters the locking hole 315, which reduces the difficulty of alignment.

[0130] The present application also provides a delivery system for an artificial implant, which has a distal end and a proximal end relative to each other. The delivery system includes a control handle 400 and a wire control mechanism whose proximal end is connected to the control handle 400. The artificial implant is connected to the distal end of the wire control mechanism and is controlled by the control handle 400.

[0131] The control handle 400 includes a support body (i.e., a first support body 410) with a guide groove (i.e., a first guide groove 4102), a base (i.e., a first base 491) moving along the guide groove, and a drive sleeve (i.e., a first drive sleeve 481) rotatably mounted on the outer periphery of the support body, and threaded transmission is provided between the drive sleeve and the base;

[0132] The support body is provided with a rotation locking mechanism 460 at the proximal side of its own guide groove for limiting or allowing the rotation of the drive sleeve. The rotation locking mechanism 460 includes:

[0133] The first pipe member 461 is fixed to the support body. The control handle 400 has a mounting channel 403 that axially penetrates the support body. A portion of the mounting channel 403 extends through the first pipe member 461.

[0134] The second pipe member 462 is rotatably sleeved on the outer periphery of the first pipe member 461, wherein a portion of the second pipe member 462 is a working section 4621 extending into the driving sleeve, and an outer wall of the working section 4621 has a protrusion 4622;

[0135] The locking member 463 is located in the radial gap between the working section 4621 and the driving sleeve, and is configured to be able to slide along the radial direction of the driving sleeve and act on the inner wall of the driving sleeve. During the rotation of the second pipe member 462, the locking member 463 is pressed by the protrusion 4622 to move and lock the driving sleeve accordingly.

[0136] The operating component 464 drives the second pipe 462 to rotate.

[0137] The delivery system of the artificial implant also includes:

[0138] The inner sheath tube 230, the lock seat 31 is fixed to the distal end of the inner sheath tube 230;

[0139] The inner core 210 is slidably disposed in the inner sheath 230. The distal end of the inner core 210 passes through the lock seat 31 and a locking rod 32 is fixed to the passing portion. The locking rod 32 moves with the inner core 210 and has the following positions:

[0140] In the locked position, the locking rod 32 is inserted into the locking hole 315 to constrain the working end of the locking wire 33;

[0141] In the release position, the locking rod 32 is disengaged from the locking hole 315 to release the working end of the locking wire 33 .

[0142] The wire control tube 220 is slidably disposed in the radial gap between the inner core 210 and the inner sheath tube 230 , and the driving end of the locking wire 33 is connected to the wire control tube 220 .

[0143] There are multiple locking rods 32 with different lengths. When in the release position, the proximal ends of all locking rods 32 are located in the guide holes 316 of the guide portion 311. Fig.26As shown, there are at least two locking rods 32, and there may also be three or more locking rods. The lengths of the locking rods 32 are different. The axial length of the guide portion 311 is made longer to ensure that when the locking rods 32 are in the release position, the proximal ends of all the locking rods 32 are also located in the guide holes 316 of the guide portion 311, rather than being exposed outside the guide portion 311. Since the proximal ends of the locking rods 32 are continuously located in the guide holes 316, the locking rods 32 and the lock seat 31 can always maintain a connection relationship, so that the locking rods 32 can switch between the locking position and the release position more smoothly and safely.

[0144] When the artificial implant 100 is in the loading state, the locking wire 33 extends out of the distal end of the inner sheath 230, passes through the artificial implant 100 and is bound to the locking rod 32. The locking rod 32 and the locking seat 31 are plugged and matched to limit the locking wire 33 from being bound. The proximal end of the locking wire 33 is connected to the control handle through the second axis. In addition to the wire control tube 220, the second axis can also be a wire. The number of wires can be multiple and correspond to the locking wire 33 one by one. For example, the locking wire 33 and the second axis are wires of an integral structure. In this embodiment and the drawings of the specification, the second axis takes the wire control tube as an example.

[0145] The relative movement of the inner core 210 and the inner sheath 230 can realize the relative movement of the lock seat 31 and the lock rod 32, thereby changing the constraint state of the lock wire 33. The state of the lock wire 33 can affect the movement process of the artificial implant 100, especially in the release process of the artificial implant 100, the staged release of the artificial implant 100 is realized by the lock wire 33. Further, the mutual movement of each pipe can provide a structural basis for the full release and full recovery of the artificial implant 100, thereby providing a more controllable interventional treatment process, improving the treatment effect and improving the patient experience. When the artificial implant 100 (fully expanded but still connected to the lock wire 33) needs to be recovered after release, the aforementioned sliding locking mechanism is unlocked, and the second handle 42 slides relative to the first handle 41 to realize the rapid withdrawal of the artificial implant 100 and be stored inside it by the outer sheath 240.

[0146] In one embodiment, the lock seat is provided with one or more grooves along the circumferential direction, and the extension end is provided with a protrusion structure along the circumferential direction that matches the number and structure of the lock seat grooves, and the locking wire is passed through the artificial implant and is gathered through the groove and protrusion structure of the lock seat. The wire control mechanism includes a lock seat, a lock wire, and a protrusion structure that matches the lock seat structure.

[0147] Referring to an embodiment, the lock seat 31 is provided with a lock hole that cooperates with the lock rod 32. In the locked state, the lock rod 32 is inserted into the lock hole and restricts the range of movement of the lock wire 33. Referring to an embodiment, the lock rod 32 moves with the inner core 210 and has the following positions:

[0148] Lock position (see attached Fig. 9 ), the locking rod 32 is inserted into the locking hole to constrain the locking wire 33;

[0149] Release position (see attached Fig.10 ), the locking rod 32 disengages from the locking hole to release the locking wire 33.

[0150] 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 artificial implant is in a loaded state, the working end is wound around the artificial implant 100 and then cooperates with the locking rod 32. There are multiple locking wires 33.

[0151] like Fig.10 As shown, in one embodiment, the locking wire 33 has a second development mark 331, which is set at the distal end of the locking wire 33 and is made of a development-type metal such as platinum-iridium alloy, gold, etc., so as to facilitate observation of the positional relationship between the locking wire 33 and the artificial implant 100, the locking seat 31 and the locking rod 32 during surgery, thereby achieving precise release and recovery operations. The second development mark 331 can be a development point or continuously distributed at the distal end of the locking wire or distributed along the entire locking wire. The second development mark 331 is connected to the locking wire 33 by bonding, sewing, weaving, riveting and other processes. The second development mark 331 has a solid or hollow structure and can have different shapes, such as ring, filament, circle, square, etc., depending on the connection process.

[0152] In interventional surgery and in vitro simulation tests, for example, during interventional delivery, the rotary locking mechanism is in a locked state, and the outer sheath 240 wraps the artificial implant 100 and the wire control mechanism until it is delivered to the surgical site, thereby improving the safety of interventional delivery. When the artificial implant is aligned and released, the rotary 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 artificial implant; after the artificial implant is successfully recovered or released, the sliding locking mechanism is unlocked, and the second handle slides proximally relative to the first handle to quickly retract the artificial implant and / or the wire control mechanism into the outer sheath and then withdraw it from the body.

[0153] Among them Figure 4 As shown, the control of the catheter assembly and the corresponding drive mechanism is as follows:

[0154] The first support body 410 is provided with a first guide groove 4102, and the second support body 420 is provided with a second guide groove 4212. A first extension sleeve 418 is fixed at the distal end of the first support body 410, and a first support 419 is fixed in the first extension sleeve 418. A first base 491 is slidably installed in the first guide groove 4102 of the first support body 410, and a first drive sleeve 481 is rotatably sleeved on the outside of the first support body 410 and threadedly matched with the first base 491; a second extension sleeve 427 is fixed at the proximal end of the second support body 420, and a second support 428 is fixed at the distal end of the second support body 420. A second base 492 and a third base 493 are slidably installed in the second guide groove of the second support body 420, and the second support body 420 is rotatably sleeved with a second drive sleeve 482 and a third drive sleeve 483 that are threadedly matched with the second base 492 and the third base 493 respectively.

[0155] The sheath 250 is fixed to the first support 419 in the first extension sleeve 418, the outer sheath 240 is fixedly connected to the first base 491, the inner sheath 230 is fixedly connected to the second support 428, the wire control tube 220 seals and passes through the second support 428 and is fixedly connected to the second base 492, and the inner core 210 is fixedly connected to the third base 493.

[0156] In one embodiment, an exhaust structure (such as a one-way valve) is provided on the control handle 400. 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, a third support 429 is provided on the second extension sleeve 427, and the second exhaust structure 4291 is provided on the third support 429. The third support 429 is connected to the second support 428 through an exhaust pipe 470, and the exhaust pipe 470 runs through the second support body 420.

[0157] 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, between the inner sheath tube and the wire control tube, and between the wire control tube and the inner core.

[0158] See also Figure 3 , Figure 12 to Figure 21 In one embodiment, two support rods 450 are arranged side by side and the two sides facing each other are provided with positioning teeth 4502. The support member in the second handle 42 includes a second support body 420, and the second support body 420 is provided with a guide hole 4222. The two support rods 450 extend into the corresponding guide holes 4222. 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. Fig.14 As shown, the sliding locking mechanism 430 is in the unlocked state, allowing the second handle 42 to slide relative to the first handle 41 along the support rod 450; and as shown Fig.13As shown, in the locked state, the second handle 42 is fixed relative to the first handle 41 .

[0159] The support rod serves as a connecting member between the second handle and the first handle, and is also provided with positioning teeth for cooperating 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.

[0160] For the convenience of description, in the following embodiments, the top side and the bottom side are based on the radial distance from the axis of the control handle, and the side farther away is the top side.

[0161] The sliding locking mechanism 430 includes a locking member 431, an elastic member 432 and an operating button 433. The locking member 431 is movably mounted on the second support body 420 and has a locking position engaged with the positioning tooth 4502 and an unlocking position disengaged from the positioning tooth 4502. The elastic member 432 (such as a spring) acts between the locking member 431 and the second support body 420 to drive the locking member 431 toward the locking position. The operating button 433 acts on the locking member 431 to drive the locking member 431 toward the unlocking position. The specific unlocking and locking operations are: manually applying a force to the operating button 433 and compressing the elastic member 432 to drive the locking member 431 to switch to the unlocking position; releasing the operating button 433, the elastic member 432 is reset and acts on the locking member 431 to switch it to the locking position.

[0162] In one embodiment, the lock 431 and the operating button 433 slide radially, and the lock 431 has an assembly hole 4311. The assembly hole 4311 is surrounded by a plurality of inner walls formed by grooves inside the lock 431. Corresponding to each inner wall, the assembly hole has a plurality of side walls, namely a top side wall, a side wall, and a bottom side wall. The assembly hole 4311 is slidably sleeved on the support rod 450, and there is an active gap 4312 between the assembly hole 4311 and the support rod 450 in a direction perpendicular to the sliding direction of the support rod 450 (i.e., the sliding direction of the lock 431). The lock 431 moves along the active gap 4312 during the process of switching the unlocking / locking position. The specific active gap 4312 is set as follows: the size of the assembly hole 4311 in the radial sliding direction of the lock 431 is greater than the thickness of the support rod 450. Combined with the attached Figure 12~Figure 15 In assembly, the lock 431 is sleeved on the support rod 450, which limits the lock 431 from escaping from the second support body 420. By utilizing different installation directions and the interaction between various components, the additional setting of a limiting structure is omitted, the component structure is simplified, and assembly is convenient.

[0163] In one embodiment, one side wall of the assembly hole 4311 faces the positioning tooth 4502, and the side wall is provided with a meshing portion 4313 that matches the positioning tooth 4502. The meshing portion 4313 is a tooth structure that matches the positioning tooth 4502. Combined with the movement direction of the lock member 431, the lock member 431 moves radially outward to the locking position and radially inward to the unlocking position, and the meshing portion 4313 is provided on the bottom side wall of the assembly hole 4311. The cross-sectional shape of the positioning tooth 4502 is a trapezoid.

[0164] In one embodiment, the number of positioning teeth 4502 is combined with the operation of the control handle as follows:

[0165] The number of the positioning teeth 4502 is one, which is used to keep the second handle at the position farthest from the first handle (i.e., the second extreme position described below);

[0166] There are multiple positioning teeth 4502 arranged at intervals along the axial direction, and the second handle can be defined at multiple positions for adjusting the position of the artificial implant in the body, or facilitating precise control of the artificial implant when retrieving the artificial implant.

[0167] The sliding locking mechanism 430 is configured with two sets, each acting on a corresponding support rod 450, and the operating buttons 433 in the two sets are arranged radially opposite to each other and in opposite directions along the second handle 42. A support rib 4201 is fixed inside the second support body 420, and the elastic member 432 is pressed between the support rib 4201 and the locking member 431.

[0168] The control handle 400 has a mounting channel 403 axially penetrating the first support body 410 . The abutment ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form corresponding spacing areas 4202 , through which the mounting channel 403 extends.

[0169] In one embodiment, the lock member 431 is provided with an alignment seat 4315 on the side facing the elastic member 432, and the elastic member 432 is inserted into or sleeved on the alignment seat 4315. In the figure, the elastic member 432 is a spring, and the alignment seat 4315 has a receiving cavity for receiving the spring part. After assembly, the elastic member 432 and the lock member 431 are blocked by the support rod 450 and will not fall out of the second support body 420. Among them, two clamping plates 4203 arranged in an axial direction are convexly provided on the abutting rib 4201, and the two clamping plates 4203 form an installation area adapted to the alignment seat 4315, restricting the axial movement of the lock member 431 and playing a role in guiding the movement of the lock member 431.

[0170] In one embodiment, the support rod 450 is a metal bar, and the radial cross section of the metal bar along the control handle is strip-shaped and substantially rectangular, and the extension direction (length direction) on the cross section is perpendicular to the spacing direction of the two support rods 450 .

[0171] In one embodiment, the support rod 450 includes a support bar 452 and a rack 453 with positioning teeth 4502, such as Fig.11 As shown, the support bar 452 is provided with a mounting groove 4521 for mounting the rack 453, and the rack 453 and the support bar 452 can be connected by embedding or fixing (for example, bonding or welding). The mounting groove 4521 is open to the bottom side and its extension range includes the sliding stroke of the second handle 42 relative to the first handle 41.

[0172] In one embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support bar 452 is as follows:

[0173] The positioning teeth 4502 protrude from the bottom side of the support bar 452;

[0174] or the positioning teeth 4502 are flush with the bottom side of the support bar 452;

[0175] Or the positioning teeth 4502 are lower than the bottom side of the support bar 452.

[0176] In one embodiment, the distal end of the second support body 420 is a second connecting seat 422, which includes two partitions 4221 and a transition portion 4223 connected between the two partitions 4221;

[0177] The transition portion 4223 as a whole 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 encloses a cylindrical shape. 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 portion of the operating button 433 is exposed for the operator to operate.

[0178] In one embodiment, the operating button 433 and the locking member 431 are engaged and fixed, and there is a locking column disposed on one of them and a locking hole disposed on the other to cooperate with the locking column. For example, in the figure, the locking column is convexly disposed on the operating button 433; the locking hole is disposed on the locking member 431 and tightly cooperates with the locking column. There are two locking columns.

[0179] See also Fig.16 In one embodiment, the second support body 420 also includes a socket 426 that is engaged between the second connecting socket 422 and the second half shell 425. The socket 426 has an open groove 4261 for exposing the operating button 433. The socket 426 surrounds the operating button 433 and fills the gap between the operating button 433 and the second support body 420 and the second half shell 425.

[0180] The open groove 4261 is circumferentially closed, and the wall of the open groove extends along the movement direction of the operating button 433 to provide a movement guide for the operating button 433 .

[0181] See also Figure 2 and Figure 18 to Figure 23 The rotation locking mechanism 460 includes a first pipe 461, a second pipe 462 and a locking member 463. It should be noted that the first pipe 461 and the second pipe 462 do not belong to the catheter assembly 200. The first pipe 461 is fixed to the support body, and the figure takes the first support body 410 as an example. A part of the installation channel 403 extends through the inside of the first pipe 461, that is, the first pipe 461 is a hollow structure through which part or all of the catheter assembly 200 can pass.

[0182] The second tube 462 is rotatably sleeved on the outer circumference of the first tube 461 . A portion of the second tube 462 is a working section 4621 extending into the rotating component 480 . The outer wall of the working section 4621 has a protrusion 4622 .

[0183] The locking member 463 is located in the radial gap between the working section 4621 and the rotating member 480, and is configured to be able to slide along the radial direction of the rotating member 480 and act on the inner wall of the rotating member 480. During the rotation process, the second tube 462 presses the locking member 463 via the protrusion 4622 to move it and correspondingly lock the rotating member 480, or the protrusion 4622 releases the pressure on the locking member 463 to unlock the rotating member 480. The protrusion direction of the protrusion 4622 includes at least the radial direction.

[0184] like Fig. 20 When in the unlocked position, there is a movable gap between the locking member 463 and the inner wall of the rotating member 480, thereby allowing the rotating member 480 to be easily rotated under human action; Fig.21 When the second tube 462 rotates around the dotted line to the locking position, the locking member 463 moves in the direction of the arrow to resist the rotating member 480, so that a sufficiently large force (such as static friction) is generated between the two, thereby limiting the rotation of the rotating member 480. The device structure can lock the rotating member 480 to any position, which is conducive to the control of the artificial implant. Compared with the existing locking structure, the operating accuracy of the control handle is improved, and the locking operation is completed in one step, simplifying the operating steps. In addition, the locking member is installed in the radial gap between the working section and the rotating member, so that the appearance of the control handle is simple, the overall shape structure is convenient for holding and operation, and the space is effectively used, making the structure of the control handle more compact.

[0185] In this embodiment, the rotation locking mechanism 460 further includes an operating component 464, which is used to drive the second pipe 462 to rotate. The operating component 464 is movably disposed on the first support body 410, and can be connected with the second pipe 462 as follows:

[0186] a. Split connection;

[0187] b. Integrally formed, for example, the second pipe 462 and the operating component 464 are integrally formed, one section of the second pipe 462 along the axial direction is the working section 4621, and the other section is connected to the operating component 464;

[0188] c. They are independent of each other and are linked and coordinated with each other through transmission parts.

[0189] The second pipe 462 has relative:

[0190] In the locked position, the protrusion 4622 is pressed against the locking member 463 and acts on the rotating member 480 to generate a pressing force thereon;

[0191] In the release position, the protrusion 4622 and the locking member 463 release the pressing force.

[0192] like Figure 17 to Figure 23 In one embodiment, the side walls of the first support body 410 and the first pipe 461 are partially opened on the same radial side to form an installation opening 4611, and the installation opening 4611 is connected to the installation channel 403 to facilitate the installation of the catheter assembly 200 and the base.

[0193] In one embodiment, the side wall of the second tube 462 is open to one side in the radial direction, and the open position is staggered in the circumferential direction with the open position of the first tube 461. The opening of one side of the second tube 462 allows the working section 4621 to have a certain deformation ability in the radial direction. For example, when locked, the inner wall of the working section 4621 abuts against the outer wall of the first tube 461, and the working section 4621 itself is subjected to forces in both radial inner and outer directions, thereby limiting the rotation of the second tube 462; when unlocking, a large driving force needs to be applied to the operating component, thereby avoiding accidental unlocking and improving safety.

[0194] The opening position of the second pipe 462 and the opening position of the first pipe 461 are staggered in the circumferential direction as follows: Fig. 20 Taking the unlocked position as an example, during the rotation of the second tube member 462 , the open opening 4623 of the second tube member 462 does not overlap with the installation opening 4611 .

[0195] Re-read Fig.18In one embodiment, the first support body 410 includes a first main body 411 and a first connection seat 412. The first main body 411 is cylindrical and extends along the axial direction of the control handle. The first pipe 461 is located at the proximal side of the first main body 411. The first connection seat 412 is fixed to the proximal end of the first main body 411 and a radial gap is left between the first pipe 461 and the second pipe 462. The radial position of the second pipe 462 is in the radial gap. The first connection seat 412 is a shell structure with a semi-cylindrical surface as a whole. The first support body 410 also includes a first half shell 414 that is fastened and fixed with the first connection seat 412 and enclosed in a cylindrical shape. The first half shell 414 is provided with an avoidance window 4181, and the operating component 464 is exposed in the avoidance window 4181. The operating component 464 is provided with an anti-slip portion 4641 and a mark 4642 for indicating locking and unlocking.

[0196] The setting of the locking piece is as follows:

[0197] like Fig. 22 In one embodiment, the first connection seat 412 is provided with a radially penetrating guide groove 4121, the locking member includes a first locking block 4631 radially slidably disposed in the guide groove 4121, and the protrusion 4622 on the second pipe 462 abuts against the radial inner side of the first locking block 4631. The outer contour of the working section 4621 of the second pipe 462 is circular, the protrusion 4622 extends along the locking rotation direction (hereinafter referred to as the first direction), and the outer surface height of the protrusion 4622 gradually increases along the first direction. The inner wall of the locking member is an arc surface that matches the outer contour of the protrusion 4622.

[0198] Based on the mutually matched shape 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. The registration structure prevents the first locking block 4631 from being incorrectly installed and locates the position of the first locking block 4631 relative to the guide groove 4121. The registration structure includes:

[0199] The positioning groove 4122 is disposed on a groove wall of the guide groove 4121 or one of the first locking blocks 4631;

[0200] The positioning block 4632 is disposed on the groove wall of the guide groove 4121 or the other of the first locking blocks 4631 and matches with the positioning groove 4122. The positioning groove 4122 is a flared structure.

[0201] like Fig.21In another embodiment, the locking member includes a first locking member and a second locking member 4635. The first locking member is slidably embedded in the first connecting seat 412, such as the first locking block 4631 in the above embodiment. The second locking member 4635 is radially engaged with the first connecting seat 412. The first locking member and the second locking member 4635 move synchronously and in opposite directions, respectively acting on different radial inner walls of the same rotating component 480, thereby improving the locking strength.

[0202] The second locking member 4635 is semi-annular and has a matching guide structure with the first support body 410. Fig.21 As shown, the guide structure includes:

[0203] The first sliding block 4633 is disposed on one of the first connecting seat 412 or the second locking member 4635;

[0204] The first sliding groove 4123 is disposed in the other one of the first connecting seat 412 and the second locking member 4635 and matched with the first sliding block 4633 .

[0205] In another embodiment, the guide structure further comprises:

[0206] The second slide groove 4101 is disposed on the first body 411;

[0207] The second sliding block 4639 is disposed on the second locking member 4635 and matches with the second sliding groove 4101 .

[0208] Re-read Fig. 20 and Fig.21 In one embodiment, the first locking member and the second locking member 4635 are at the same axial position and are located at two opposite radial sides of the second tube 462. In another embodiment, the locking member 463 includes a plurality of locking members arranged along the axial direction, for example, the plurality of locking members act on different axial positions of the same rotating component.

[0209] The anti-skid pad 4643 is embedded in the position where the locking member 463 cooperates with the rotating member 480. In combination with the above, the first locking block 4631 and the second locking member 4635 are both embedded with the anti-skid pad 4643. Fig.18 The first locking block 4631 and the second locking member 4635 are made of hard materials, and can slide stably after being matched with the first connecting seat 412. The anti-skid pad 4643 is made of soft material, and has a high friction coefficient and a certain amount of deformation, such as rubber. When locked, the anti-skid pad 4643 is squeezed with the inner wall of the rotating component 480, thereby increasing the static friction.

[0210] 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, at least maintaining a gap between the second locking member 4635 and the inner wall of the rotating component 480 at all times, so that the rotating component 480 can rotate smoothly when in the unlocked position.

[0211] The inner wall of the second locking member 4635 is a radial undulating structure, which includes an arc surface 4638 (with the axis of the control handle as the center of the circle) and an escape area 4637 that is radially recessed in the unlocked position to escape the protrusion 4622. Fig. 20 When in the unlocked position, the radially protruding high section of the protrusion 4622 is located in the avoidance area 4637. Fig.21 When in the locked position, the section abuts against the arc surface 4638 and drives the second locking member 4635 to slide radially outward.

[0212] In one embodiment, the first connecting seat 412 has a blocking portion 4124 that abuts against the operating component 464 to limit its rotation range. In the figure, there are two blocking portions 4124 and they are sheet-like structures. The operating component 464 abuts against one of the blocking portions 4124 in the locked position and the unlocked position respectively.

[0213] In one embodiment, a partial area of ​​the first support body 410 is radially penetrated to form a first guide groove 4102, and a base (for example, a first base 491) is slidably arranged in the first guide groove 4102, and the base is used to connect a controlled component (for example, the catheter assembly 200); the rotating component 480 is a driving sleeve, and the driving sleeve is rotatably sleeved on the outer periphery of the first support body 410, and a threaded transmission is cooperated between the inner wall of the driving sleeve and the base, so that the aforementioned anti-slip pad 4643 can better adapt to the threaded structure of the driving sleeve.

[0214] Regarding the rotation locking mechanism, the rotation locking mechanism is independent of the number of handles. For example, the control handle 400 includes one handle, and the rotation locking mechanism is disposed on the handle.

[0215] In one embodiment, the proximal end of the first support body 410 is fixedly connected to two connecting sleeves 440, and the distal end of each support rod 450 is fixedly inserted into the corresponding connecting sleeve 440, and the two can be fixed by snap connection or connected by fasteners.

[0216] The supporting member of the second handle 42 comprises a second supporting body 420, the distal end of the second supporting body 420 comprises two partitions 4221 arranged at intervals along the axial direction, each partition 4221 is provided with a guide hole 4222, the second supporting body 420 is provided with third slide grooves 4211 extending along the axial direction on two radially opposite sides, each support rod 450 passes through the corresponding guide hole 4222 and is placed in the corresponding third slide groove 4211, the second handle 42 as a whole slides with respect to the first handle 41 along the two support rods 450, and has two extreme positions close to / away from the first handle 41, which are respectively as follows: Figure 2 The second handle 42 shown is abutted against the first extreme position of the first handle 41, and Figure 3 The second handle 42 is shown in a second extreme position away from the first handle 41 .

[0217] The support rod is rod-shaped, which is easy to process and has lower processing costs; and there are more optional materials, for example, hard metal can be used to improve the structural strength of the supporting component of the first handle, and improve the connection stability between the first handle and the second handle, that is, the support rod is not easy to bend or break when the second handle is away from the first handle.

[0218] In addition, in order to ensure the sliding stability of the second handle, two support rods are provided. In addition, in view of the structural shape of the support rod, the cross-section shape is small, the occupied space is smaller, and it is convenient to arrange it in the space inside the second handle.

[0219] The control handle 400 has a mounting channel 403 that axially penetrates the first support body 410 and the second support body 420, and the mounting channel 403 is for the catheter assembly 200 to pass through. The first support body 410 includes a first main body 411 and a first connecting seat 412. The first main body 411 is columnar and extends axially, the first connecting seat 412 is fixed to the proximal end of the first main body 411, and two connecting sleeves 440 are fixed to the first connecting seat 412 and are located on both sides of the radial direction of the mounting channel 403. Specifically, the connecting sleeve 440 is integrally formed with the first main body 411 and the proximal end is open for the support rod 450 to be inserted.

[0220] The connection between the support rod 450 and the connecting sleeve 440 is as follows:

[0221] like Fig.11 and Fig.23 As shown, the side wall (radially outer side) of the connecting sleeve 440 and the distal end of the support rod 450 are provided with corresponding positioning holes, and are fixedly connected by a connecting member 442 passed through the positioning hole. For example, the connecting member 442 is a screw, and the support rod 450 is provided with a threaded hole that cooperates with the screw.

[0222] In one embodiment, the first connection seat 412 is a shell structure with a semi-cylindrical surface as a whole, wherein the shell structure is a part of the outer shell and can be held. The first support body 410 also includes a first half shell 414 that is fastened and fixed to the first connection seat 412 and forms a cylindrical shape with the shell structure. The connection sleeve 440 is located at the junction of the first connection seat 412 and the first half shell 414, and the outer wall of the connection sleeve 440 is provided with a buckle 415 that matches the first half shell 414.

[0223] In a preferred embodiment, the installation direction of the first half shell 414 is radial, 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 limit 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 surface of the buckle 415 located on the connecting sleeve 440 along the axial direction of the control handle.

[0224] Part of the structure of the first support body 410 also serves as part of the outer shell, which saves manufacturing costs and simplifies the connection method with the outer shell.

[0225] In one embodiment, the first connecting seat 412 is disposed on a side opposite to the slot of the first guide slot 4102, and a connecting line of the two connecting sleeves 440 is arranged at 90 degrees to the slot direction.

[0226] like Figure 12~Figure 24 In one embodiment, the support rod 450 is a metal strip, and the metal strip is strip-shaped along the radial cross section of the control handle, and the extension direction (ie, the length direction) on the cross section is perpendicular to the spacing arrangement direction of the two support rods 450 .

[0227] Wherein, the second support body 420 includes:

[0228] The second body is columnar and extends axially, and the third slide groove 4211 is located on a side of the second body facing away from the installation channel 403;

[0229] The second connecting seat 422 includes two partitions 4221 and a transition portion 4223 connected between the two partitions 4221, wherein one of the partitions 4221 is fixed to the far end of the second body;

[0230] The third connecting seat 423 is fixed to the proximal end of the second body.

[0231] The third slide groove 4211 is provided on the back of the second body, which is convenient for observing the assembly of the support rod 450. And since the support rod 450 is in the shape of a strip, the space occupied by the second body is reduced, and the structural strength of the second body is ensured. Among them, the second support 428 is installed inside the second connecting seat 422, and the second body is provided with a groove 4213 constituting a channel, and the partition at the proximal end (i.e., the second partition 4221b described below) is provided with an avoidance hole 4226. The exhaust pipe 470 extends from the second support 428 after connecting with the duct assembly, passes through the open side of the transition part 4223, and then passes through the avoidance hole 4226 and the groove 4213 until it is connected to the third support 429. The groove 4213 is provided on the outer wall of the second guide groove 4212.

[0232] Continue reading Fig.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. The distal end of the first partition 4221a is buckled with a cover plate 424, and the cover plate 424 is provided with an escape 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 as a whole. The second support body 420 also includes a second half shell 425 buckled and fixed with the transition portion 4223 and enclosed in a cylindrical shape, wherein the cover plate 424 is buckled and fixed with the first partition 4221a and the second half shell 425.

[0233] The distal end of the first partition plate 4221a is provided with a positioning rib 4225 extending in the radial direction, and the cover plate 424 is provided with a positioning groove 4242 cooperating with the positioning rib 4225. The two partition plates 4221 are opened along the first radial direction X from their respective installation channel positions to their own edges, and the cover plate 424 is opened along the second radial direction Y opposite to the first radial direction X from the installation channel position to its own edge, and the positioning groove 4242 is formed.

[0234] In one embodiment, the proximal end of the third slide groove 4211 is the end section extending to the outer periphery of the third connecting seat 423, and a mutually cooperating snap-fit ​​structure is provided between the groove wall of the end section and the support rod 450. Specifically, the snap-fit ​​structure includes:

[0235] The clamping block 4231 is protruded from the groove wall of the third sliding groove 4211;

[0236] The clamping slot 4501 is arranged on the support rod 450 and cooperates with the clamping block 4231. When the second handle 42 is in the first extreme position, the clamping block 4231 and the clamping slot 4501 cooperate with each other, that is, the clamping slot 4501 is arranged adjacent to the proximal end of the support rod 450. The clamping structure only provides a certain damping. After the sliding locking mechanism is unlocked, a certain external force is applied to the second handle to release the cooperation between the clamping structures. The clamping structure prevents the operator from accidentally unlocking the sliding locking mechanism and causing the second handle to slide, thereby improving the safety of use.

[0237] In one embodiment, a proximal portion of the support rod 450 is provided with an anti-slipping piece, and when the second handle slides proximally relative to the first handle to an extreme position (i.e., the second extreme position), the anti-slipping piece is blocked by the partition. The anti-slipping piece can be integrally formed with the support rod 450 or fixed separately, for example, the anti-slipping piece is a screw, wherein the screw includes a screw rod screwed into the support rod 450 and a nut protruding from the upper surface of the support rod 450, and when the second handle 42 is in the second extreme position, the nut abuts against the end surface of the second partition 4221b. During assembly, the support rod 450 is first inserted through the second partition 4221b, and then the anti-slipping piece is installed.

[0238] In the delivery system of the present application, the support rod serves as a connecting member between the second handle and the first handle, and can also improve the structural strength of the control handle. It cooperates with the sliding locking mechanism to maintain the length of the control handle and meet operational requirements, such as the rapid withdrawal of the artificial implant and precise control of the artificial implant during retrieval.

[0239] The present application also provides a method for releasing an artificial implant 100 based on in vitro simulation, which is implemented using the interventional system of the artificial implant 100. The method for releasing the artificial implant 100 includes:

[0240] providing artificial implants;

[0241] The artificial implant 100 with the first developing mark 332 is loaded into the interventional delivery system with the reference mark 241, and the circumferential relative position of the first developing mark 332 and the reference mark 241 is adjusted according to a preset angle;

[0242] During the release process, the overall circumferential position of the interventional delivery system is maintained so that the artificial implant 100 is located in a preset matching posture.

[0243] See also Fig.31As shown, when the control handle 400 controls the artificial implant 100 to enter the target position, the catheter assembly 200 passes through multiple turns. When the catheter assembly is not bent, the first developing mark 332 on the artificial implant 100 at the joint has a circumferential relative position with the circumference of the control handle. When the artificial implant 100 reaches the target position, after multiple turns and twists of the catheter assembly, the first developing mark 332 on the artificial implant 100 is displayed as shown in FIG. Fig.31 The position shown, that is, there is a relatively definite relationship between the circumferential position of the control handle 400 and the artificial implant 100. When the artificial implant 100 is loaded with a certain circumferential offset relative to the control handle 400, when the artificial implant 100 reaches the target position, the position of its commissure is aligned with the native valve commissure.

[0244] See also Fig.32 As shown, when the first developing mark 332 of the artificial heart valve located on the far left is aligned with the reference mark 241 on the control handle, after the artificial heart valve is released, the connection part 130 is not aligned with the native valve connection 140, but just blocks the coronary artery opening. When the first developing mark 332 on the artificial heart valve is rotated according to 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 connection part 130 is aligned with the connection 140 of the native valve, avoiding blocking of the coronary artery opening.

[0245] See also Figure 1a , Fig.29 , Fig.30 As shown, the interventional system is in a state of being assembled, the circumferential relative positions of the control handle 400, the catheter assembly 200 and the wire control mechanism remain unchanged, the artificial implant 100 is connected to the interventional system through the wire control mechanism, and the locking wire 33 in the wire control mechanism passes through and is wrapped around the artificial implant 100. Under the traction of the locking wire 33, the circumferential position of the artificial implant 100 is also determined.

[0246] The artificial implant 100 has a first developing mark 332, and the circumferential position of the first developing mark 332 is determined (refer to Fig. 20 , Fig.30 As shown, Fig.30 The position indicated by the middle arrow H can be understood as the circumferential position of the first development mark 332). The circumferential relative position of the first development mark 332 and the reference mark 241 is adjusted according to the preset angle. When the circumferential position of the first development mark 332 remains unchanged, that is, the circumferential position of the reference mark 241 is adjusted, a fixed scale can be set on the circumference of the control handle 400, and the origin of the scale corresponds to the circumferential position of the first development mark 332 on the artificial implant 100, that is, Fig.29 and Fig.30 The location of the midpoint line.

[0247] A rotating component 260 is provided on the control handle 400, and a reference mark 241 and a placing surface are provided on the rotating component 260, or a reference mark 241 and a plurality of supporting parts are provided on the rotating component 260. When the rotating component is rotated, the circumferential positions of the reference mark 241 and the placing surface are changed simultaneously, or the circumferential positions of the reference mark 241 and the plurality of supporting parts are changed simultaneously.

[0248] By rotating the reference mark 241 on the control handle 400, the reference mark 241 and the first developing mark 332 have a preset angle (see Fig.30 As shown), 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.

[0249] The first developing mark 332 indicates the circumferential position of the artificial implant 100, and the reference mark 241 indicates the circumferential position of the control handle 400 when it is in use. During the release process, the circumferential relative position of the first developing mark 332 and the reference mark 241 is always kept unchanged, and the position of the reference mark 241 of the control handle 400 is kept unchanged, that is, the circumferential position of the reference mark 241 is kept unchanged (that is, the placing surface or supporting part corresponding to the reference mark maintains the circumferential position unchanged). When the artificial implant is released into place, it can reach the preset matching posture.

[0250] The preset angle can be determined in a variety of ways, for example, by simulation training, specifically, in a simulation environment, the reference mark 241 and the first development mark 332 are changed to different circumferential positions, and the preset angle is obtained by multiple releases. Alternatively, the preset angle can be obtained by image comparison, after obtaining the preset angle for an image of a certain standard heart model, and then comparing the difference between the images of the heart model to be released and the standard heart model.

[0251] In the present application, after the artificial implant is loaded into the interventional system, a circumferential position with a preset angle is provided between the artificial implant and the control handle of the interventional system. During the release process, the circumferential position of the control handle is kept 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 in one go after release, it can be aligned with the native valve by making slight adjustments using existing technology).

Claims

1. An interventional system for an artificial implant, having a distal end and a proximal end opposite to each other, the interventional system as a whole having an axial direction after being straightened and corresponding radial and circumferential directions, characterized in that: The interventional system comprises: A control handle, the control handle having a top side and a bottom side opposite to each other in a radial direction, the control handle having a use state with the top side facing upward, and the control handle having a reference mark for indicating the use state; a catheter assembly, the proximal end of which is connected to and controlled by the control handle; An artificial implant, the artificial implant having a first developing mark, the artificial implant being loaded to the distal end of the catheter assembly according to a preset angle, the preset angle corresponding to the circumferential offset amplitude between the first developing mark and the reference mark when the control handle is in use; The artificial implant is bound by a locking wire and releasably loaded on the catheter assembly, and the catheter assembly comprises: A third shaft, a distal end of which is connected to a lock seat, and the lock seat has a lock hole; A second shaft, the locking wire is connected to the distal end of the second shaft, and the locking wire is connected to the locking seat after passing through the artificial implant to restrain or release the artificial implant; A first shaft, a locking rod connected to a distal end of the first shaft for maintaining the connection between the locking wire and the locking seat; The control handle comprises a support body, a base slidably mounted on the support body, and a driving sleeve rotatably sleeved on the support body and threadedly driven with the base; The control handle further includes a rotation locking mechanism for limiting or allowing the drive sleeve to rotate, and the rotation locking mechanism includes: A first pipe member, fixed to the support body; A second pipe member, the rotating sleeve of which is arranged on the outer periphery of the first pipe member, wherein a portion of the second pipe member is a working section extending into the driving sleeve, and an outer wall of the working section has a convex portion; A locking member is located in a radial gap between the working section and the driving sleeve and is configured to be able to slide along the radial direction of the driving sleeve and act on the inner wall of the driving sleeve. During the rotation of the second pipe member, the locking member is pressed by the protruding portion to move and lock the driving sleeve accordingly; The base at least includes a second base linked to the locking wire and a third base linked to the locking rod.

2. The artificial implant intervention system according to claim 1, characterized in that: The locking wire has a second developing mark, and the second developing mark has an axial displacement and a radial displacement relative to the catheter assembly during the release of the artificial implant. When the artificial implant radially expands to a maximum extent, the second developing mark has a maximum radial displacement.

3. The artificial implant intervention system according to claim 2, characterized in that: The artificial implant includes a stent and a plurality of leaflets connected to the stent, the stent has a connection portion corresponding to the splicing position of adjacent leaflets in the circumferential direction, and the circumferential positions of the first developing mark and the second developing mark correspond to one of the connection portions.

4. The artificial implant intervention system according to claim 1, characterized in that: The artificial implant is an artificial heart valve, which has an inflow end and an outflow end, and includes: A bracket, which is cylindrical and has a grid structure; A skirt, wherein the skirt is sewn to the inflow end of the stent to form a blood flow channel with the stent; A plurality of leaflets are sewn to the outflow end of the skirt, each leaflet is in the blood flow channel and cooperates with each other to control blood flow interruption, the leaflet includes a fixed edge connected to the skirt and fixed to the bracket, and a free edge that cooperates with adjacent leaflets to control the blood flow channel; the artificial heart valve is provided with a third developing mark at a position adjacent to the inflow end.

5. The artificial implant intervention system according to claim 4, characterized in that: The farthest end point of the leaflet fixing edge is connected to the stent grid node.

6. The artificial implant intervention system according to claim 4, characterized in that: The third imaging mark is axially displaced from the most distal end point of the leaflet fixing edge.

7. The artificial implant intervention system according to claim 4, characterized in that: The valve comprises an inflow area, a valve area, and an outflow area. The inflow area is composed of at least one row of circumferentially distributed rhombus cells. Adjacent cells are circumferentially interconnected to form interconnection points. The third development mark is located at the interconnection point.

8. The artificial implant intervention system according to claim 4, characterized in that: The control handle is held in use by its shape or positioning means, wherein: The self shape includes a resting surface or a plurality of supporting parts on the bottom side; A corresponding coupling structure is provided between the positioning device and the control handle.

9. The artificial implant intervention system according to claim 1, characterized in that: The control handle comprises a first handle and a second handle that cooperate with each other, the proximal ends of the first shaft, the second shaft and the third shaft are all connected to the second handle, and the catheter assembly further comprises: The outer sheath has a proximal end connected to the first handle and a distal end used for covering the artificial implant.

Images