Artificial heart valve control handle

Abstract

The present application discloses an artificial heart valve control handle. The control handle includes a first handle and a second handle that are slidably and positionally engaged. Each handle includes a support member and a drive mechanism disposed on the support member. The support member in the first handle includes a first support body and two struts fixedly connected to the first support body and extending proximally. The two struts are arranged side by side, and positioning teeth are arranged on the side facing each other. The support member in the second handle includes a second support body. The second support body is provided with guiding holes, and the two struts slidably extend into the corresponding guiding holes. The second handle is further provided with a sliding locking mechanism that cooperates with the positioning teeth to limit the relative positions of the first handle and the second handle. The struts serve both as a connecting member between the second handle and the first handle, and are provided with positioning teeth for cooperating with the sliding locking mechanism to control the position of the second handle relative to the first handle, simplifying the structure of the control handle while satisfying the operation of the control handle.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and specifically to a control handle for an artificial heart valve. Background Art

[0002] The delivery system of an artificial implant generally includes a control handle configured on the proximal side for the operator to manipulate, and several slender sliding nested shaft components (such as catheters, etc.). Among them, the control handle is connected to each shaft component and controls the relative changes of the distal ends of the shaft components to complete the delivery, release, or recovery of the artificial implant. Therefore, the control handle generally has sliding or rotating components for driving the relative axial movement between the catheters.

[0003] In the prior art, the control handle includes a first handle and a second handle that move relative to each other. A connecting member is provided between the first handle and the second handle for one of the handles to move, and a corresponding locking mechanism is additionally provided to maintain the locking between the two, making the structure of the control handle more complex. Summary of the Invention

[0004] This application provides a control handle for an artificial heart valve, which is more compact in structure.

[0005] This application provides a control handle for an artificial heart valve, having opposite distal and proximal ends. The control handle includes a first handle and a second handle that are slidably and positionally matched. Each handle includes a support member and a driving mechanism provided on the support member;

[0006] The support member in the first handle includes a first support body and two struts fixedly connected to the first support body and extending proximally. The two struts are arranged side by side, and positioning teeth are arranged on the facing sides;

[0007] The support member in the second handle includes a second support body. The second support body includes a partition and is provided with a guiding hole. The two struts slidably extend into the corresponding guiding holes. The second handle is further provided with a sliding locking mechanism that cooperates with the positioning teeth to limit the relative positions of the first handle and the second handle. An anti - detachment member is provided at the proximal part of the strut. When the second handle slides proximally relative to the first handle to the extreme position, the anti - detachment member is blocked by the partition.

[0008] The following also provides several optional ways, but they are not additional limitations to the above general solution. They are only further supplements or preferences. Without technical or logical contradictions, each optional way can be combined with the above general solution alone, or multiple optional ways can be combined with each other.

[0009] Optionally, the sliding locking mechanism includes:

[0010] A locking member is movably installed on the second support body and has a locking position engaged with the positioning teeth and an unlocking position disengaged from the positioning teeth;

[0011] An elastic member acts between the locking member and the second support body, driving the locking member to move radially outward relative to the axis of the control handle to tend to the locking position;

[0012] An operating button is fixedly connected to the locking member, driving the locking member to move radially inward relative to the axis of the control handle to tend to the unlocking position.

[0013] Optionally, the locking member is provided with an assembly hole and is sleeved on the support rod through the assembly hole in a sliding manner. There is an activity gap between the assembly hole and the support rod in the direction perpendicular to the sliding direction of the locking member, and the locking member moves along this activity gap during the process of switching positions.

[0014] Optionally, the positioning teeth are arranged radially outward relative to the axis of the control handle. One side wall of the assembly hole faces the positioning teeth, and an engaging portion matched with the positioning teeth is provided on this side wall. The engaging portion is one or more engaging teeth arranged at intervals along the sliding direction of the locking member.

[0015] Optionally, the cross-sectional shape of the positioning teeth is trapezoidal.

[0016] Optionally, the two support rods are symmetrically arranged relative to the axis of the control handle. Two sets of the sliding locking mechanisms are configured and act on the corresponding support rod respectively. The operating buttons in the two sets are aligned with each other along the radius of the second handle and are arranged in opposite directions.

[0017] Optionally, a resisting rib is fixed inside the second support body, and the elastic member is pressed and acts between the resisting rib and the locking member.

[0018] Optionally, the resisting ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area allows the installation channel to extend through.

[0019] Optionally, a positioning seat is provided on one side of the locking member facing the elastic member, and the elastic member is inserted into or sleeved on the positioning seat.

[0020] Optionally, the distal part of the second support body is a second connecting seat, including two of the partition plates and a transition part connected between the two partition plates;

[0021] The transition part is a shell structure with a semi-cylindrical surface as a whole. The second support body further includes a second half shell that is fastened and fixed to the transition part and encloses a cylindrical shape. The sliding locking mechanism is located in the area surrounded by the transition part and the second half shell, and only a part of the operating button is exposed.

[0022] Optionally, the second support body further includes a clamping seat clamped between the second connecting seat and the second half shell, and the clamping seat is provided with an open slot for the operation button to be exposed.

[0023] Optionally, the open slot is circumferentially closed and extends along the movement direction of the operation button.

[0024] For the control handle of the artificial heart valve of the present application, the strut not only serves as a connecting member between the second handle and the first handle, but also is provided with positioning teeth to cooperate with the sliding locking mechanism to control the position of the second handle relative to the first handle, meeting the operation of the control handle and simplifying the structure of the control handle. Description of the Drawings

[0025] Figure 1 It is a structural view of the delivery system according to an embodiment of the present application;

[0026] Figure 2 It is Figure 1 a structural view of the control handle in

[0027] Figure 3 It is Figure 1 a schematic structural view of the second handle sliding proximally relative to the first handle in the control handle in

[0028] Figure 4 It is Figure 2 a cross-sectional view of the control handle along its own axis in

[0029] Figure 5 It is an exploded view of the second handle in the control handle of the present application;

[0030] Figure 6 It is Figure 1 an enlarged view of part A in

[0031] Figure 7 It is a partial structural view of the cooperation between the locking rod and the locking seat in the control mechanism according to an embodiment of the present application;

[0032] Figure 8 It is a cross-sectional view of the catheter assembly according to an embodiment of the present application;

[0033] Figure 9 It is a schematic diagram of the state when the artificial implant is released distally and the locking wire is relaxed in the delivery system according to an embodiment of the present application;

[0034] Figure 10 It is a schematic diagram of the state when the artificial implant is released distally and the locking wire is released in the delivery system according to an embodiment of the present application;

[0035] Figure 11 It is a structural view of the second support body in the control handle according to an embodiment of the present application;

[0036] Figure 12 Explosion view between the strut and the first handle in the control handle according to an embodiment of the present application;

[0037] Figure 13 Explosion view of the sliding locking mechanism in the control handle according to an embodiment of the present application;

[0038] Figure 14 is Figure 4 Enlarged view of part B (the sliding locking mechanism is in the locked state) in;

[0039] Figure 15 is Figure 4 Enlarged view of part B (the sliding locking mechanism is in the unlocked state) in;

[0040] Figure 16 Structural view of the lock in the control handle according to an embodiment of the present application;

[0041] Figure 17 Assembly schematic diagram between the lock and the strut in the control handle according to an embodiment of the present application;

[0042] Figure 18 Structural view of the operating button in the control handle according to an embodiment of the present application;

[0043] Figure 19 Explosion view of the second half shell and the second drive sleeve in the control handle according to an embodiment of the present application;

[0044] Figure 20 Explosion view of the operating button in the control handle according to an embodiment of the present application;

[0045] Figure 21 Structural view of the card seat in the control handle according to an embodiment of the present application;

[0046] Figure 22 Structural view of the first support body in the control handle according to an embodiment of the present application;

[0047] Figure 23 Partial structural view when the second handle is in the second extreme position in the control handle according to an embodiment of the present application;

[0048] Figure 24 Structural view of the engagement structure between the strut and the chute in the control handle according to an embodiment of the present application;

[0049] Figure 25 is Figure 11 Partial structural view of the proximal part of the second support body in;

[0050] Figure 26 is Figure 23 Enlarged view of part G in;

[0051] Figure 27 is Figure 12 A partial structural view between the middle strut and the anti-disengagement member;

[0052] Figure 28 is a structural view of an artificial implant according to an embodiment of the present application;

[0053] Figure 29 is Figure 28 A partial view at the anti-peripheral leakage component.

[0054] The descriptions of the reference numerals in the figure are as follows:

[0055] 100, artificial implant; 110, stent; 111, mesh structure; 112, inflow side; 120, valve leaf; 130, anti-peripheral leakage component; 140, inner film; 150, blood flow channel;

[0056] 200, catheter assembly; 210, inner core; 220, wire control tube; 230, inner sheath tube; 240, outer sheath tube; 250, sheath;

[0057] 31, lock seat; 32, lock rod; 33, lock wire; 331, developing mark;

[0058] 400, control handle; 401, proximal end; 402, distal end; 403, installation channel;

[0059] 41, first handle; 410, first support body; 4102, first guide groove;

[0060] 418, first extension sleeve; 419, first support;

[0061] 42, second handle; 420, second support body; 4201, abutting rib; 4202, spacer area; 4203, clamping plate; 4204, installation area; 4211, third chute;

[0062] 422, second connection seat; 4212, second guide groove; 4221, partition; 4221a, first partition; 4221b, second partition; 4222, guiding hole; 4223, transition part; 4225, positioning rib;

[0063] 423, third connection seat; 4231, clamping block;

[0064] 424, cover plate; 4241, avoidance area; 4242, positioning groove;

[0065] 425, second half shell; 426, card seat; 4261, open slot;

[0066] 427, second extension sleeve; 428, second support;

[0067] 430. Sliding locking mechanism; 431. Locking member; 4311. Assembly hole; 4312. Moving clearance; 4313. Engaging portion; 4314. Locking hole; 4315. Alignment seat;

[0068] 432. Elastic member; 433. Operating button; 4331. Locking post;

[0069] 440. Connecting sleeve;

[0070] 450. Support rod; 4501. Card slot; 4502. Positioning tooth;

[0071] 451. Anti - detachment member; 4511. Nut; 4512. Screw rod; 452. Support bar; 453. Rack; 4521. Installation groove;

[0072] 480. Rotating member; 481. First driving sleeve; 482. Second driving sleeve; 483. Third driving sleeve;

[0073] 491. First base; 492. Second base; 493. Third base. Detailed implementation manners

[0074] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts belong to the scope of protection of the present application.

[0075] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0076] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0077] In this application, terms such as "first" and "second" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance or implicitly specifying the quantity or order of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of this application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically and clearly defined.

[0078] This specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body. The delivery system includes a control handle and a catheter assembly. The control handle can be connected to and control the catheter assembly for performing an interventional procedure. The catheter assembly includes a plurality of controlled members. The distal ends of the respective controlled members cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking the position, adjusting the spatial attitude, etc. Each controlled member itself can be a hollow tube, a solid rod, a flexible wire, or a combination of various forms. There are a plurality of controlled members, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axis or rotate relative to each other around the axis.

[0079] Hereinafter, when used to indicate directions, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the relatively far - away side. Along the interventional path, each component itself has a relative distal end and proximal end; theoretically, when the catheter assembly and the control handle are completely straightened, a straight line is formed between the proximal end and the distal end, which determines the axis. Correspondingly, the radial direction perpendicular to the axis and the circumferential direction arranged around the axis are also determined; when used to refer to a structure, the "end" in the text represents the end point of the structure or a certain point or a certain area in that side direction or the specific structure connected to that point or area.

[0080] The artificial implant can be an artificial heart valve or a vascular stent, etc. The artificial heart valve can include a stent and leaflets connected to the stent for controlling blood flow on - off. The number of leaflets is generally two or three. According to needs, a skirt design can be added to the inner side and / or outer side of the stent. The stent itself can be formed by weaving or tube cutting. The artificial heart valve can be used to replace a diseased valve in the heart, such as the aortic valve.

[0081] Refer to Figure 1 and Figure 2 , this application provides a delivery system for an artificial implant, having opposite distal end 402 and proximal end 401. The delivery system includes a control handle 400 and a catheter assembly 200 proximally 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.

[0082] Refer to Figures 2 to 15, the control handle 400 of the present application has the same distal end 402 and proximal end 401 as described above. The control handle 400 includes a first handle 41 and a second handle 42 that are slidably positioned and fitted. Each handle includes a support member and a drive mechanism provided on the support member. The drive mechanism is in multiple groups, and each group is connected to a catheter assembly for controlling a control mechanism located at the distal end of the catheter assembly to complete actions such as expansion, release, and recovery of an artificial implant. The support member is used to provide a basis for the installation and movement of the drive mechanism and / or another handle and the structural support of the corresponding handle.

[0083] The support member in the first handle 41 includes a first support body 410 and two struts 450 fixedly connected to the first support body 410 and extending proximally. The two struts 450 are arranged side by side, and positioning teeth 4502 are arranged on the side facing each other. The support member in the second handle 42 includes a second support body 420. The second support body 420 is provided with a guiding hole 4222. The two struts 450 slidably extend into the corresponding guiding holes 4222. The second handle 42 is further provided with a sliding locking mechanism 430 that cooperates with the positioning teeth 4502 to limit the relative positions of the first handle 41 and the second handle 42. As Figure 15 shown, when the sliding locking mechanism 430 is in the unlocked state, the second handle 42 is allowed to slide relative to the first handle 41 along the struts 450; while as Figure 14 shown, in the locked state, the position of the second handle 42 relative to the first handle 41 is fixed.

[0084] The strut serves not only as a connecting member between the second handle and the first handle, but also has positioning teeth for cooperating with the sliding locking mechanism to control the position of the second handle relative to the first handle, meeting the operation of the control handle and simplifying the structure of the control handle.

[0085] 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 with a farther distance is the top side.

[0086] The catheter assembly 200 sequentially includes an outer sheath tube 240 and at least one shaft from the outside to the inside in the radial direction. One of the shafts represents one or more shafts fixed to each other. For example, two pipe fittings fixed to each other can also be regarded as one shaft. As Figure 8 shown, the catheter assembly 200 specifically includes an outer sheath tube 240, a third shaft (such as the following inner sheath tube 230), a second shaft (such as the following wire control tube 220), and a first shaft (such as the following inner core 210). The first shaft, the second shaft, and the third shaft belong to the inner shaft assembly. Among them, the distal end of the inner core 210 is provided with a guiding head.

[0087] Refer to Figures 4 to 10, the proximal end of the outer sheath tube 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 move relatively away from or close to the first handle 41, so as to realize the simultaneous driving of the first shaft, the second shaft and the third shaft to move rapidly relative to the outer sheath tube 240. The "sliding" in the "sliding locking mechanism" means that the second handle 42 makes a sliding movement relative to the first handle 41.

[0088] In one embodiment, a first extension sleeve 418 is further fixed to the distal end of the first support 410. The catheter assembly 200 further includes a sheath 250 sleeved outside the outer sheath tube 240 and having its proximal end fixed to the first handle 41.

[0089] A lock seat 31 is connected to the distal part of the inner sheath tube 230. One end of the inner core 210 is an extension section extending out of the distal end of the inner sheath tube 230. A lock rod 32 is fixed to the extension section and is located on the distal side of the lock seat 31. The distal end of the wire control tube 220 is connected to a lock wire 33. The lock wire 33 is wound around the artificial implant 100 and then tightened or loosened on the lock seat 31 to bind or release the artificial implant 100. Among them, the lock seat 31, the lock wire 33 and the lock rod 32 constitute the above control mechanism.

[0090] When the artificial implant 100 is in the loaded state, the lock wire 33 extends out of the distal end of the inner sheath tube 230, winds around the artificial implant 100 and then is bound to the lock rod 32. The lock rod 32 is inserted and matched with the lock seat 31 to limit the lock wire 33 from breaking free. The proximal end of the lock wire 33 is connected to the control handle through the second shaft. In addition to being the wire control tube 220, the second shaft can also be a wire. The number of wires can be multiple and correspond to the lock wire 33 one by one. For example, the lock wire 33 and the second shaft are an integral structure wire. In this embodiment and the accompanying drawings of the specification, the second shaft is taken as an example of the wire control tube.

[0091] The relative movement between the inner core 210 and the inner sheath tube 230 can achieve the relative movement between the lock seat 31 and the lock rod 32, thereby changing the restraint state of the lock wire 33. The state of the lock wire 33 can affect the movement process of the artificial implant 100. Especially during the release process of the artificial implant 100, the phased release of the artificial implant 100 is achieved through the lock wire 33. Further, the relative movement of each pipe fitting can provide a structural basis for the full release and full recovery return journey of the artificial implant 100, thereby providing a more controllable interventional treatment process, improving the treatment effect while enhancing the patient experience. When the expanded artificial implant 100 (fully expanded but still connected to the lock wire 33) needs to be recovered, the aforementioned sliding locking mechanism is unlocked, and the second handle 42 slides relative to the first handle 41 to achieve the rapid retraction of the artificial implant 100 and be received inside the outer sheath tube 240. Or after the artificial implant is successfully released, the sliding locking mechanism is unlocked, the second handle slides proximally relative to the first handle, the inner shaft assembly is quickly retracted into the outer sheath tube, so that the guide head just engages with the outer sheath tube 240, and then withdrawn from the body, which can improve the operation efficiency and reduce the safety hazard during the overall retraction.

[0092] In one embodiment, the lock seat is provided with one or more grooves along the circumferential direction, and the extending end is provided with a convex structure that matches the number and structure of the grooves of the lock seat. The lock wire winds around the artificial implant and is restrained through the grooves and convex structures of the lock seat. Among them, the control mechanism includes the lock seat, the lock wire, and the convex structure that matches the structure of the lock seat.

[0093] Referring to one 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 to restrict the movement range of the lock wire 33. Referring to one embodiment, the lock rod 32 moves with the inner core 210 and has the following positions:

[0094] Locked position (refer to the appendix Figure 9 ), the lock rod 32 is inserted into the lock hole to restrict the lock wire 33;

[0095] Release position (refer to the appendix Figure 10 ), the lock rod 32 disengages from the lock hole to release the lock wire 33.

[0096] In one embodiment, the catheter assembly 200 further includes a wire control tube 220 that is movably sleeved outside the inner core 210. One end of the lock wire 33 is a driving end and is connected to the wire control tube 220, and the other end of the lock wire is a working end. In the loaded state of the artificial implant, the working end winds around the artificial implant 100 and then cooperates with the lock rod 32. Among them, there are multiple lock wires 33.

[0097] Such as Figure 10As shown, in one embodiment, the locking wire 33 has a developing mark 331, which is arranged at the distal end of the locking wire 33 and is made of developing metals such as platinum-iridium alloy and gold, 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 the operation, thereby achieving accurate release and recovery operations. The developing mark 331 is connected to the locking wire 33 by bonding, sewing, weaving, riveting and other processes, and the developing 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.

[0098] The driving mechanism includes a base that slides along the axial direction of the control handle and a driving sleeve that is rotatably mounted on the outer periphery of the corresponding support body. The driving sleeve and the base are threadedly driven. Some components in the catheter assembly 200 are connected to the base and complete corresponding actions under the drive of the driving sleeve, and each support body is provided with a rotation locking mechanism that can limit or allow the driving sleeve to rotate. In interventional surgery and in vitro simulation tests, for example, during interventional delivery, the rotation locking mechanism is in a locked state, and the outer sheath 240 wraps the artificial implant 100 and the 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 rotation 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 recovery or release of the artificial implant is successful, the sliding locking mechanism is unlocked, and the second handle slides toward the proximal end relative to the first handle, and the artificial implant and / or the control mechanism are quickly retracted into the outer sheath, and then withdrawn from the body.

[0099] Among them Figure 4 , Figure 11 and Figure 22 As shown, the control of the catheter assembly and the corresponding driving mechanism, the control handle includes a rotating component 480 sleeved on the support body, the rotating component 480 is a cylindrical structure and has opposite inner and outer walls, as follows:

[0100] 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.

[0101] The sheath 250 is fixed to the first support 419 within the first extension sleeve 418, the outer sheath tube 240 is fixedly connected to the first base 491, the inner sheath tube 230 is fixedly connected to the second support 428, the wire control tube 220 hermetically penetrates 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.

[0102] The strut serves both 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, satisfying the operation of the control handle and simplifying the structure of the control handle.

[0103] For the convenience of description, in the following embodiments, the top side and the bottom side are determined with reference to the axis of the control handle at a radial distance, and the side with a greater distance is the top side.

[0104] Among them, the sliding locking mechanism 430 includes a locking member 431, an elastic member 432 and an operation button 433. The locking member 431 is movably installed on the second support body 420 and has a locking position engaged with the positioning teeth 4502 and an unlocking position disengaged from the positioning teeth 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 towards the locking position; the operation button 433 acts on the locking member 431 to drive the locking member 431 towards the unlocking position. The specific unlocking and locking operations are as follows: manually apply a force to the operation button 433 and compress the elastic member 432 to drive the locking member 431 to switch to the unlocking position; release the operation button 433, and the elastic member 432 resets and acts on the locking member 431 to switch it to the locking position.

[0105] In one embodiment, the locking member 431 and the operation button 433 move radially. The locking member 431 is provided with an assembly hole 4311, which is surrounded by a plurality of inner walls formed by slotting inside the locking member 431. Corresponding to each inner wall, the assembly hole has a plurality of side walls, namely a top side wall, a circumferential side wall, and a bottom side wall. The strut 450 is sleeved through the assembly hole 4311, and there is a clearance 4312 between the assembly hole 4311 and the strut 450 in the direction perpendicular to the sliding direction of the strut 450 (i.e., the sliding direction of the locking member 431). The locking member 431 moves along the clearance 4312 during the process of switching between the unlocking / locking positions. The specific clearance 4312 is set such that the size of the assembly hole 4311 in the radial sliding direction of the locking member 431 is greater than the thickness of the strut 450. Figures 13 to 17 In terms of assembly, the locking member 431 is sleeved on the strut 450, which restricts the locking member 431 from disengaging from the second support body 420. By using different installation directions and the interaction between components, additional limiting structures are eliminated, the component structure is simplified, and the assembly is convenient.

[0106] In one embodiment, the positioning teeth 4502 are arranged radially outward relative to the axis of the control handle. One side wall of the assembly hole 4311 faces the positioning teeth 4502, and an engaging portion 4313 that cooperates with the positioning teeth 4502 is provided on this side wall. The engaging portion 4313 is a tooth structure that cooperates with the positioning teeth 4502. Considering the movement direction of the locking member 431, when the locking member 431 moves radially outward relative to the axis of the control handle, it tends to move towards the locked position, and when it moves radially inward, it tends to move towards the unlocked position. Therefore, the engaging portion 4313 is arranged on the bottom side wall of the assembly hole 4311. Among them, the cross-sectional shape of the positioning teeth 4502 is trapezoidal.

[0107] In one embodiment, the number of the positioning teeth 4502 is combined with the operation of the control handle as follows:

[0108] The number of the positioning teeth 4502 is one, which is used to keep the second handle at the position where the distance from the first handle is the farthest to realize the closing of the proximal end of the seeker and the distal end of the outer sheath tube (i.e., the following second limit position);

[0109] The number of the positioning teeth 4502 is multiple and they are arranged at intervals along the axis. They can limit the second handle at multiple positions, be used to adjust the position of the artificial implant in the body, or adjust the covering distance of the outer sheath tube 240 to the artificial implant when retrieving the artificial implant.

[0110] Among them, the two support rods 450 are symmetrically arranged relative to the axis of the control handle. Two sets of sliding locking mechanisms 430 are configured and act on the corresponding one support rod 450 respectively. The operation buttons 433 in the two sets are arranged radially opposite and in opposite directions along the second handle 42. An abutting rib 4201 is fixed in the second support body 420, and the elastic member 432 is pressed between the abutting rib 4201 and the locking member 431.

[0111] The control handle 400 is internally provided with an installation channel 403 that penetrates the first support body 410 axially. The abutting ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form a corresponding interval area 4202. As Figure 11 shown, the interval area 4202 allows the installation channel 403 to extend through.

[0112] In one embodiment, the locking 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 illustration, the elastic member 432 is a spring, and the alignment seat 4315 has a receiving cavity for receiving a part of the spring. After assembly, the elastic member 432 and the locking member 431 are blocked by the support rod 450 and will not come out of the second support body 420. Among them, two clamping plates 4203 are convexly arranged on the abutting rib 4201 at intervals along the axial direction. An installation area 4204 that is adapted to the alignment seat 4315 and restricts the axial movement of the locking member 431 is formed between the two clamping plates 4203, and it also plays a role in guiding the movement of the locking member 431. In the illustration, the locking member 431 and the operation button 433 are fixedly connected, for example, by clamping.

[0113] In one embodiment, the support rod 450 is a metal strip. The radial cross-section of the metal strip along the control handle is strip-shaped and approximately rectangular, and the extending direction (length direction) in this cross-section is perpendicular to the interval arrangement direction of the two support rods 450.

[0114] In one embodiment, the support rod 450 includes a support strip 452 and a rack 453 with positioning teeth 4502, as Figure 12 shown, wherein the support strip 452 is provided with an installation groove 4521 for installing the rack 453. The connection mode between the rack 453 and the support strip 452 can be embedded or fixedly connected (such as bonding or welding, etc.). Among them, the installation groove 4521 is open towards the bottom side, and its extending range includes the sliding stroke of the second handle 42 relative to the first handle 41.

[0115] In one embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support strip 452 is as follows:

[0116] The positioning teeth 4502 protrude from the bottom side of the support strip 452;

[0117] Or the positioning teeth 4502 are flush with the bottom side of the support strip 452;

[0118] Or the positioning teeth 4502 are lower than the bottom side of the support strip 452.

[0119] In one embodiment, the distal part of the second support body 420 is a second connecting seat 422, which includes two partition plates 4221 and a transition part 4223 connected between the two partition plates 4221;

[0120] The transition part 4223 is generally a shell structure with a semi-cylindrical surface. The second support body 420 further includes a second half-shell 425 that is fixedly buckled with the transition part 4223 and encloses a cylindrical shape. The sliding locking mechanism 430 is located in the area surrounded by the transition part 4223 and the second half-shell 425, and only a part of the operation button 433 is exposed for the operator to operate.

[0121] Refer to Figure 16 andFigure 18 In one embodiment, the operating button 433 and the locking member 431 are snap-fitted and fixed. There is a clamping post provided on one of them and a clamping hole provided on the other and cooperating with the clamping post. For example, in the illustrated figure, the clamping post 4331 protrudes from the operating button 433; the clamping hole 4314 is provided in the locking member 431 and is in a tight fit with the clamping post 4331. There are two clamping posts 4331.

[0122] Refer to Figure 20 and Figure 21 In one embodiment, the second support 420 further includes a clamping seat 426 clamped between the second connecting seat 422 and the second half shell 425. The clamping seat 426 has an open slot 4261 for the operating button 433 to be exposed. The clamping seat 426 surrounds the circumference of the operating button 433 and fills the gap between the operating button 433 and the second support 420 and the second half shell 425.

[0123] Among them, the open slot 4261 is circumferentially closed, and the slot wall of the open slot extends along the movement direction of the operating button 433 to provide a movement guide for the operating button 433.

[0124] In one embodiment, two connecting sleeves 440 are fixedly connected to the proximal part of the first support 410, and the distal parts of the respective struts 450 are fixedly inserted into the corresponding connecting sleeves 440. The fixing method between the two can be snap connection or connection by fasteners.

[0125] See Figure 11 and Figure 13 The support member of the second handle 42 includes a second support 420. The distal part of the second support 420 includes two partition plates 4221 arranged at intervals along the axis. A guiding hole 4222 is formed in each partition plate 4221. The second support 420 is respectively provided with third sliding grooves 4211 extending along the axis on the two radially opposite sides. Each strut 450 passes through the corresponding guiding hole 4222 and is placed in the corresponding third sliding groove 4211. The second handle 42 as a whole slides relative to the first handle 41 along the two struts 450 and has two limit positions of approaching / away from the first handle 41, which are respectively the first limit position where the second handle 42 abuts against the first handle 41 as shown in Figure 2 and the second limit position where the second handle 42 is away from the first handle 41 as shown in Figure 3 .

[0126] Continue to refer to Figure 13, in one embodiment, the two partition plates 4221 include a first partition plate 4221a at the distal end and a second partition plate 4221b at the proximal end. A cover plate 424 is buckled on the distal side of the first partition plate 4221a. The cover plate 424 is provided with an avoidance area 4241 corresponding to the positions of the installation channel 403 and the guiding hole 4222. Between the two partition plates 4221, that is, the transition part 4223 is generally a shell structure with a semi-cylindrical surface. The second support body 420 further includes a second half shell 425 that is buckled and fixed to the transition part 4223 and encloses a cylindrical shape. The cover plate 424 is buckled and fixed to the first partition plate 4221a and the second half shell 425.

[0127] A positioning rib 4225 extending radially is provided on the distal side of the first partition plate 4221a. The cover plate 424 is provided with a positioning groove 4242 that cooperates with the positioning rib 4225. The two partition plates 4221 extend open from the positions of their respective installation channels along the first radial direction X to their own edges. The cover plate 424 extends open from the position of the installation channel along the second radial direction Y opposite to the first radial direction X to its own edge, and a positioning groove 4242 is formed.

[0128] As Figures 23 to 25 shown, in one embodiment, the proximal part of the third sliding groove 4211 is the end section extending to the outer periphery of the third connecting seat 423. A engaging structure that cooperates with each other is provided between the groove wall of the end section and the support rod 450. Specifically, the engaging structure includes:

[0129] A clamping block 4231 protruding from the groove wall of the third sliding groove 4211;

[0130] A clamping groove 4501 provided on the support rod 450 and cooperating with the clamping block 4231. When the second handle 42 is in the first extreme position, the clamping block 4231 and the clamping groove 4501 cooperate with each other, that is, the clamping groove 4501 is adjacent to the proximal end of the support rod 450. This engaging structure only provides a certain damping. After the sliding locking mechanism is unlocked, applying a certain external force to the second handle can release the cooperation between the engaging structures. This engaging structure avoids the accidental unlocking of the sliding locking mechanism by the operator, resulting in the sliding of the second handle, and improves the use safety.

[0131] As Figure 26 and Figure 27As shown, in one embodiment, an anti - detachment member 451 is provided at the proximal part of the strut 450. When the second handle slides proximally relative to the first handle to the extreme position (i.e., the second extreme position), the anti - detachment member 451 is blocked by the partition plate. The anti - detachment member 451 can be integrally formed with the strut 450 or fixedly attached separately. For example, the anti - detachment member 451 is a screw, where the screw includes a screw rod 4512 screwed into the strut 450 and a nut 4511 protruding from the upper surface of the strut 450. When the second handle 42 is in the second extreme position, the nut 4511 abuts against the end face of the second partition plate 4221b. During assembly, first insert the strut 450 through the second partition plate 4221b, and then install the anti - detachment member 451.

[0132] Reference Figure 28 and Figure 29 , the present application also provides an artificial implant 100, which has a stent 110 with a grid structure 111 and in a cylindrical shape. Inside the stent 110 is a blood flow channel 150. A plurality of valve leaflets 120 inside the stent cooperate with each other in the blood flow channel to relatively open or close the blood flow channel 150. The stent 110 has a corresponding axial direction (axis direction), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The grid structure can be understood as a cylindrical side wall with a hollowed - out area. The edges of the hollowed - out area are the frame bars that enclose the grid, and there are no strict limitations on the size and specific shape of the grid. In the axial direction of the stent, they are respectively an inflow side 112 and a relative outflow side according to the normal blood flow direction in the body. The stent itself can be processed by cutting or weaving a pipe, and corresponding materials are used according to the release method in the body (such as self - expanding or balloon - expanding).

[0133] Among them, the artificial implant 100 further includes an inner lining membrane 140 connected to the stent 110 and located in the blood flow channel 150. The inner lining membrane 140 is generally connected to the corresponding frame bars of the stent by sewing. The outflow side of the inner lining membrane 140 is joined with the inflow side of each valve leaflet 120, and the joining method is, for example, sewing. The artificial implant 100 further includes a plurality of anti - peripheral leakage components 130. The plurality of anti - peripheral leakage components 130 are arranged circumferentially along the stent 110 and are embedded in the grid structures 111 at corresponding positions. The plurality of anti - peripheral leakage components 130 surround and close along the circumferential direction of the stent 110. All the grid structures in the same layer are filled and embedded by the anti - peripheral leakage components 130. The anti - peripheral leakage components protrude from the corresponding grid structures and are used to interact with the surrounding tissues in the body to prevent blood flow from passing through the periphery of the artificial implant. The anti - peripheral leakage components 130 are connected to the inner lining membrane 140, and the two are fixed by at least one of bonding, heat fusion, sewing, infiltration, or dip - coating.

[0134] In the control handle of the present application, the strut not only serves as a connecting member between the second handle and the first handle, but also is provided with positioning teeth to cooperate with the sliding locking mechanism to control the position of the second handle relative to the first handle, meeting the operation of the control handle and also simplifying the structure of the control handle.

[0135] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered as the scope described in this specification. When the technical features in different embodiments are embodied in the same drawing, the drawing can be regarded as also disclosing the combination examples of the respective embodiments involved.

[0136] The above embodiments only express several implementation manners of the present application, and the description thereof is relatively specific and detailed, but it should not be construed as a limitation on the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. An artificial heart valve control handle having opposite distal and proximal ends, characterized in that: The control handle comprises a first handle and a second handle which are slidably positioned and matched, and each handle comprises a supporting member and a driving mechanism arranged on the supporting member; The support member in the first handle includes a first support body and two strip-shaped support rods fixedly connected to the first support body and extending toward the proximal end, wherein the two support rods are arranged side by side and positioning teeth are arranged on the opposite sides thereof; The supporting member in the second handle comprises a second supporting body, the second supporting body comprises a partition and is provided with a guide hole, the two support rods are slidably extended into the corresponding guide holes, the second supporting body is respectively provided with a third slide groove extending along the axial direction on two radially opposite sides, each support rod passes through the corresponding guide hole and is placed in the corresponding third slide groove, the second supporting body is also provided with a sliding locking mechanism that cooperates with the positioning teeth to maintain a relative position with the first supporting body, the proximal end of the support rod is provided with an anti-slip piece, when the second handle slides to the proximal end to the extreme position relative to the first handle, the anti-slip piece is blocked by the partition; The second support body is provided with a second guide groove, in which a second base is slidably installed, and the second support body is rotatably sleeved with a second driving sleeve which is respectively threadedly matched with the second base.

2. The artificial heart valve control handle according to claim 1, characterized in that: The sliding locking mechanism comprises: A lock element, movably mounted on the second support body, having a locking position engaged with the positioning teeth and an unlocking position disengaged from the positioning teeth; an elastic member, acting between the locking member and the second support body, driving the locking member to move radially outward relative to the axis of the control handle toward a locking position; The operating button is fixedly connected to the locking element and drives the locking element to move radially inward relative to the axis of the control handle to move toward an unlocking position.

3. The artificial heart valve control handle according to claim 2, characterized in that: The locking element has an assembly hole and is slidably sleeved on the support rod through the assembly hole. There is an active gap between the assembly hole and the support rod in a direction perpendicular to the sliding direction of the support rod, and the locking element moves along the active gap during the process of switching positions.

4. The artificial heart valve control handle according to claim 3, characterized in that: The positioning tooth is arranged radially outward relative to the axis of the control handle, one side wall of the assembly hole faces the positioning tooth, and the side wall is provided with an engaging portion matching the positioning tooth, and the engaging portion is one or more locking teeth arranged at intervals along the sliding direction of the lock.

5. The artificial heart valve control handle according to claim 2, characterized in that: The two support rods are arranged symmetrically relative to the axis of the control handle. The sliding locking mechanism is configured with two sets, each acting on a corresponding support rod. The operating buttons in the two sets are aligned with each other along the radial direction of the second handle and arranged in opposite directions.

6. The artificial heart valve control handle according to claim 5, characterized in that: A supporting rib is fixed in the second supporting body, and the elastic member is pressed between the supporting rib and the locking member.

7. The artificial heart valve control handle according to claim 6, characterized in that: The control handle is provided with a mounting passage axially penetrating the first support body. The abutment ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the mounting passage extends through the interval area.

8. The artificial heart valve control handle according to claim 6, characterized in that: The locking element is provided with an alignment seat on a side facing the elastic element, and the elastic element is inserted into or sleeved on the alignment seat.

9. The artificial heart valve control handle according to claim 2, characterized in that: The distal end of the second support body is a second connecting seat, which includes two baffles and a transition portion connected between the two baffles; The transition part as a whole is a shell structure with a semi-cylindrical surface, and the second support body also includes a second half shell that is snap-fitted and fixed to the transition part and forms a cylindrical shape. The sliding locking mechanism is located in the area enclosed by the transition part and the second half shell, and only a portion of the operating button is exposed.

10. The artificial heart valve control handle according to claim 9, characterized in that: The second support body further comprises a clamping seat engaged between the second connecting seat and the second half shell, and the clamping seat has an open slot for exposing the operating button.

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