Artificial heart valve control handle

Abstract

The invention discloses an artificial heart valve control handle which comprises a first handle body and a second handle body which are in sliding positioning fit, and each handle body comprises a supporting component and a driving mechanism arranged on the supporting component. A supporting component in the first handle comprises a first supporting body and two supporting rods which are fixedly connected to the first supporting body and extend towards the near end, the two supporting rods are arranged side by side, and positioning teeth are arranged on the opposite sides of the two supporting rods. A supporting component in the second handle comprises a second supporting body, guide holes are formed in the second supporting body, the two supporting rods extend into the corresponding guide holes in a sliding mode, and the second handle is further provided with a sliding locking mechanism which is matched with the positioning teeth to limit the relative position of the first handle and the second handle. The supporting rod serves as a connecting component between the second handle and the first handle and is further provided with positioning teeth used for being matched with the sliding locking mechanism to control the position of the second handle relative to the first handle, operation of the control handle is met, and meanwhile the structure of the control handle is simplified.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to an artificial heart valve control handle. Background Art

[0002] The delivery system of artificial implants generally includes a control handle configured at the proximal end for the operator to control, and a number of slender sliding nested shaft components (such as catheters, etc.). The control handle is connected to each shaft component and controls the distal ends of the shaft components to change mutually to complete the delivery, release or recovery of the artificial implant, so the control handle is generally configured with a sliding or rotating component to drive the relative movement between the catheters along the axial direction.

[0003] In the prior art, the control handle includes a first handle and a second handle that move relative to each other, wherein a connecting member is provided between the first handle and the second handle for allowing 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 complicated. Summary of the invention

[0004] The present application provides an artificial heart valve control handle with a more compact structure.

[0005] The present application provides an artificial heart valve control handle, which has a distal end and a proximal end opposite to each other, the control handle comprises a first handle and a second handle that are slidably positioned and matched, each handle comprises a support member and a driving mechanism disposed on the support member; The support member in the first handle includes a first support body and two 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 structure in the second handle includes a second supporting body, the second supporting body includes a partition and is provided with a guide hole, the two support rods slide into the corresponding guide holes, the second handle is also provided with a sliding locking mechanism that cooperates with the positioning teeth to limit the relative position of the first handle and the second handle, the proximal end of the support rod is provided with an anti-slip component, when the second handle slides proximally to the extreme position relative to the first handle, the anti-slip component is blocked by the partition.

[0006] 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.

[0007] Optionally, 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.

[0008] Optionally, the locking element has an assembly hole and is slidably mounted on the support rod through the assembly hole. There is a movable gap between the assembly hole and the support rod in a direction perpendicular to the sliding direction of the locking element, and the locking element moves along the movable gap during the process of switching positions.

[0009] Optionally, 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.

[0010] Optionally, the cross-sectional shape of the positioning tooth is trapezoidal.

[0011] Optionally, the two support rods are arranged symmetrically relative to the axis of the control handle, and the sliding locking mechanism is configured with two sets, each acting on a corresponding support rod, and the operating buttons in the two sets are radially aligned with each other along the second handle and arranged in opposite directions.

[0012] Optionally, abutment ribs are fixed in the second support body, and the elastic member is pressed between the abutment ribs and the locking member.

[0013] Optionally, the abutment ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area is for the installation channel to extend through.

[0014] Optionally, the locking member is provided with an alignment seat on a side facing the elastic member, and the elastic member is inserted into or sleeved on the alignment seat.

[0015] Optionally, the distal end of the second support body is a second connecting seat, which includes two partitions and a transition portion connected between the two partitions; 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.

[0016] Optionally, the second support body further includes a socket engaged between the second connecting socket and the second half shell, and the socket has an open slot for exposing the operating button.

[0017] Optionally, the open groove is circumferentially closed and extends along the movement direction of the operating button.

[0018] The artificial heart valve control handle of the present application uses a strut as a connecting member between the second handle and the first handle, and is also provided with positioning teeth for cooperating with a 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 A structural diagram of a conveying system according to an embodiment of the present application; Figure 2 for Figure 1 Structural view of the middle control handle; Figure 3 for Figure 1 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; Figure 4 for Figure 2 A cross-sectional view of the middle control handle along its own axis; Figure 5 This is an exploded view of the second handle in the control handle of the present application; Figure 6 for Figure 1 Middle A enlarged view; Figure 7 A partial structural view of a lock rod and a lock seat in a control mechanism of an embodiment of the present application when the lock rod and the lock seat cooperate; Figure 8 A cross-sectional view of a catheter assembly according to an embodiment of the present application; 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; 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; Fig.11 This is a structural view of a second support body in a control handle according to an embodiment of the present application; Fig.12 An exploded view between the support rod and the first handle in a control handle according to an embodiment of the present application; Fig.13 An exploded view of a sliding locking mechanism in a control handle according to an embodiment of the present application; Fig.14 for Figure 4Enlarged view of middle section B (slide lock mechanism in locked state); Fig.15 for Figure 4 Enlarged view of middle section B (slide lock mechanism in unlocked state); Fig.16 This is a structural view of a lock in a control handle according to an embodiment of the present application; Fig.17 This is a schematic diagram of the assembly between the lock element and the support rod in the control handle of one embodiment of the present application; Fig.18 This is a structural view of an operating button in a control handle according to an embodiment of the present application; Fig.19 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; Fig. 20 An exploded view of an operating button in a control handle according to an embodiment of the present application; Fig.21 This is a structural view of a card holder in a control handle according to an embodiment of the present application; Fig. 22 This is a structural view of a first support body in a control handle according to an embodiment of the present application; 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; 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; Fig.25 for Fig.11 A local structural view of the proximal portion of the second support body; Fig.26 for Fig.23 Enlarged view of middle G section; Fig. 27 for Fig.12 A partial structural view between the middle support rod and the anti-dropping piece; Fig.28 This is a structural view of an artificial implant according to an embodiment of the present application; Fig.29 for Fig.28 Partial view at the anti-leakage component.

[0020] The reference numerals in the figures are described as follows: 100, artificial implant; 110, stent; 111, mesh structure; 112, inflow side; 120, valve leaflet; 130, anti-leakage component; 140, inner covering membrane; 150, blood flow channel; 200, catheter assembly; 210, inner core; 220, wire control tube; 230, inner sheath tube; 240, outer sheath tube; 250, sheath; 31. Lock seat; 32. Lock rod; 33. Lock line; 331. Development mark; 400, control handle; 401, proximal end; 402, distal end; 403, installation channel; 41. first handle; 410. first support body; 4102. first guide groove; 418, first extension sleeve; 419, first support; 42, second handle; 420, second support body; 4201, abutting rib; 4202, spacing area; 4203, clamping plate; 4204, installation area; 4211, third slide groove; 422, second connecting seat; 4212, second guide groove; 4221, partition; 4221a, first partition; 4221b, second partition; 4222, guide hole; 4223, transition part; 4225, positioning rib; 423, third connecting seat; 4231, card block; 424, cover plate; 4241, avoidance area; 4242, positioning groove; 425, second half shell; 426, card seat; 4261, open slot; 427, second extension sleeve; 428, second support; 430, sliding locking mechanism; 431, locking member; 4311, assembly hole; 4312, movable gap; 4313, meshing portion; 4314, clamping hole; 4315, alignment seat; 432, elastic member; 433, operating button; 4331, clamping column; 440, connecting sleeve; 450, support rod; 4501, slot; 4502, positioning tooth; 451, anti-dropping piece; 4511, nut; 4512, screw rod; 452, support bar; 453, rack; 4521, mounting groove; 480, rotating member; 481, first driving sleeve; 482, second driving sleeve; 483, third driving sleeve; 491, first base; 492, second base; 493, third base. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0022] It should be noted that when a component is referred to as being "connected" to another component, it may be directly connected to the other component or there may be a central component. When a component is referred to as being "disposed on" another component, it may be directly disposed on the other component or there may be a central component at the same time.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this application belongs. The terms used herein in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

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

[0025] The present specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body, wherein the delivery system includes a control handle and a catheter assembly, wherein the control handle can be connected to and control the catheter assembly for performing an interventional procedure, wherein the catheter assembly includes a plurality of controlled components, wherein the distal ends of the controlled components cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking a position, adjusting a spatial posture, etc., and each controlled component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms, and there are multiple controlled components, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axial direction or rotate relative to each other around the axial direction.

[0026] In the following text, when used to indicate direction, the proximal end generally refers to the side adjacent to the operator (such as a doctor), and the distal end refers to the relatively farther side. Along the interventional path, each component has a relative distal and proximal end. In theory, when the catheter assembly and the control handle are fully straightened, the straight line between the proximal and distal ends determines the axial direction, and correspondingly also determines the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction. When used to refer to a structure, the "end" in the text indicates the endpoint of the structure or a point or area on that side or a specific structure connected to that point or area.

[0027] The artificial implant may be an artificial heart valve or a vascular stent, etc. The artificial heart valve may include a stent and leaflets connected to the stent to control blood flow interruption. The number of leaflets is generally two or three. A skirt design may be added to the inner and / or outer sides of the stent as needed. The stent itself may be formed by weaving or tube cutting. The artificial heart valve may be used to replace diseased valves in the heart, such as the aortic valve.

[0028] See also Figure 1 and Figure 2 The present application provides a delivery system for an artificial implant, having 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.

[0029] See also Figure 2~Figure 15 The control handle 400 of the present application has the same distal end 402 and proximal end 401 as the aforementioned. The control handle 400 includes a first handle 41 and a second handle 42 that are slidably positioned and matched. Each handle includes a support member and a driving mechanism disposed on the support member. The driving mechanism is a plurality of groups, each of which is connected to a catheter assembly to control a 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 foundation for the installation and movement of the driving mechanism and / or another handle and a structural support for the corresponding handle.

[0030] 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 to the proximal end. The two support rods 450 are arranged side by side and have positioning teeth 4502 arranged on the opposite sides. The support member in the second handle 42 includes a second support body 420. The second support body 420 is provided with a guide hole 4222. The two support rods 450 slide into the corresponding guide hole 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.15As 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.14 As shown, in the locked state, the second handle 42 is fixed relative to the first handle 41 .

[0031] 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.

[0032] 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.

[0033] 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 axis (such as the inner sheath 230 described below), a second axis (such as the wire-controlled tube 220 described below) and a first axis (such as the inner core 210 described below), the first axis, the second axis and the third axis belong to the inner axis assembly, wherein the distal end of the inner core 210 is provided with a guide head.

[0034] See also Figure 4~Figure 10 , the proximal end of the outer sheath 240 is movably connected to the first base 491 in the first handle 41, and the distal end is used to wrap the artificial implant 100; the proximal end of the third axis is fixed to the second handle 42, the proximal end of the second axis is movably connected to the second base 492 in the second handle 42, and the proximal end of the first axis is movably connected to the proximal part of the second handle 42. The first axis, the second axis and the third axis are all controlled by the second handle 42. When the sliding locking mechanism is unlocked, the second handle 42 can be relatively far away from or close to the first handle 41, thereby realizing the rapid movement of the first axis, the second axis and the third axis relative to the outer sheath 240 at the same time. The "sliding" in the "sliding locking mechanism" refers to the sliding movement of the second handle 42 relative to the first handle 41.

[0035] 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.

[0036] 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 control mechanism.

[0037] 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.

[0038] 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. Or after the artificial implant is successfully released, the sliding locking mechanism is unlocked, and the second handle slides proximally relative to the first handle to quickly retract the inner shaft assembly into the outer sheath tube so that the guide head is just connected to the outer sheath tube 240 and then withdrawn from the body, which can improve operating efficiency and reduce safety hazards during overall withdrawal.

[0039] In one embodiment, the lock seat is provided with one or more grooves along the circumference, and the extension end is provided with a protrusion structure along the circumference 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 control mechanism includes the lock seat, the locking wire, and the protrusion structure that matches the lock seat structure.

[0040] 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: Lock position (see attached Fig. 9 ), the locking rod 32 is inserted into the locking hole to constrain the locking wire 33; Release position (see attached Fig.10 ), the locking rod 32 disengages from the locking hole to release the locking wire 33.

[0041] 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.

[0042] like Fig.10 As 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.

[0043] 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.

[0044] Among them Figure 4 , Fig.11 and Fig. 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 a relative inner wall and outer wall, as follows: 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] 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.

[0049] In one embodiment, the lock 431 and the operating button 433 move 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, which are a top side wall, a peripheral side wall, and a bottom side wall. The assembly hole 4311 is slidably mounted on the support rod 450, and an active gap 4312 is provided 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 13~Figure 17 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.

[0050] In one embodiment, the positioning tooth 4502 is arranged radially outward relative to the axis of the control handle, 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 locking element 431, the locking element 431 moves radially outward relative to the axis of the control handle to tend to the locking position, and moves radially inward to tend to the unlocking position, and the meshing portion 4313 is arranged on the bottom side wall of the assembly hole 4311. The cross-sectional shape of the positioning tooth 4502 is a trapezoid.

[0051] In one embodiment, the number of positioning teeth 4502 combined with the operation of the control handle is as follows: The number of the positioning teeth 4502 is one, which is used to keep the second handle at the farthest position relative to the first handle to achieve the closure of the proximal end of the guide head and the distal end of the outer sheath (i.e., the second extreme position described below); 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 adjusting the covering distance of the outer sheath 240 on the artificial implant when retrieving the artificial implant.

[0052] The two support rods 450 are arranged symmetrically with respect to the axis of the control handle, and 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 opposite to each other in the radial direction of the second handle 42. A supporting rib 4201 is fixed inside the second support body 420, and the elastic member 432 is pressed between the supporting rib 4201 and the locking member 431.

[0053] The control handle 400 has a mounting channel 403 that axially penetrates the first support body 410. The abutting ribs 4201 in the two sets of sliding locking mechanisms are arranged at intervals and form corresponding spacing areas 4202. Fig.11 As shown, the spacer 4202 allows the mounting channel 403 to extend through.

[0054] 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 are convexly arranged in the axial direction on the abutting rib 4201, and the two clamping plates 4203 form an installation area 4204 that is adapted to the alignment seat 4315 and limits the axial movement of the lock member 431 and plays a role in guiding the movement of the lock member 431. In the figure, the lock member 431 and the operating button 433 are fixedly connected, for example, fixed by clamping.

[0055] 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 .

[0056] In one embodiment, the support rod 450 includes a support bar 452 and a rack 453 with positioning teeth 4502, such as Fig.12 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.

[0057] In one embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support bar 452 is as follows: The positioning teeth 4502 protrude from the bottom side of the support bar 452; or the positioning teeth 4502 are flush with the bottom side of the support bar 452; Or the positioning teeth 4502 are lower than the bottom side of the support bar 452.

[0058] 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; 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.

[0059] See also Fig.16 and Fig.18 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 4331 is convexly disposed on the operating button 433; the locking hole 4314 is disposed on the locking member 431 and tightly cooperates with the locking column 4331. There are two locking columns 4331.

[0060] See also Fig. 20 and Fig.21 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.

[0061] 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 .

[0062] 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.

[0063] See also Fig.11 and Fig.13 The supporting member of the second handle 42 includes a second supporting body 420, and the distal end of the second supporting body 420 includes two partitions 4221 arranged in an axial direction at intervals, each partition 4221 is provided with a guide hole 4222, and the second supporting body 420 is provided with a third slide groove 4211 extending in the axial direction on two radially opposite sides, and 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 relative 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 .

[0064] Continue reading Fig.13 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.

[0065] 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 from their respective installation channel positions along the first radial direction X to their own edges, and the cover plate 424 is opened from the installation channel position along the second radial direction Y opposite to the first radial direction X to its own edge, and the positioning groove 4242 is formed.

[0066] like Figure 23~Figure 25 As shown, 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: The clamping block 4231 is protruded from the groove wall of the third sliding groove 4211; 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.

[0067] like Fig.26 and Fig. 27As shown, in one embodiment, the proximal portion of the support rod 450 is provided with an anti-slipping member 451, 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 member 451 is blocked by the partition. The anti-slipping member 451 can be integrally formed with the support rod 450 or fixed separately, for example, the anti-slipping member 451 is a screw, wherein the screw includes a screw 4512 screwed into the support rod 450 and a nut 4511 protruding from the upper surface of the support rod 450, and when the second handle 42 is in the second extreme position, the nut 4511 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 member 451 is installed.

[0068] refer to Fig.28 and Fig.29 The present application also provides an artificial implant 100, which has a cylindrical stent 110 with a grid structure 111. The interior of the stent 110 is a blood flow channel 150. The multiple leaflets 120 in 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 (axial 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 hollow area, and the edge of the hollow area is the frame bar surrounding the grid. There is no strict limitation on the size and specific shape of the grid. In the axial direction of the stent, according to the normal blood flow direction in the body, they are the inflow side 112 and the corresponding outflow side. The stent itself can be cut or woven by pipe material, and the corresponding material is used according to the release method in the body (such as self-expansion or ball expansion).

[0069] Among them, the artificial implant 100 also includes an inner coating 140 connected to the stent 110 and located in the blood flow channel 150. The inner coating 140 is generally connected to the frame strip corresponding to the stent position by sewing, wherein the outflow side of the inner coating 140 is spliced ​​with the inflow side of each leaflet 120, and the splicing method is, for example, sewing. The artificial implant 100 also includes a plurality of anti-peripheral leakage components 130, and a plurality of anti-peripheral leakage components 130 are arranged along the circumference of the stent 110 and embedded in the grid structure 111 corresponding to the position. The plurality of anti-peripheral leakage components 130 are surrounded and closed along the circumference of the stent 110, and all grid structures in the same circle are filled and embedded by the anti-peripheral leakage components 130. The anti-peripheral leakage components protrude from the corresponding grid structure, 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 coating 140, and the two are fixed by at least one of bonding, thermal fusion, suturing, infiltration or dipping.

[0070] In the control handle of the present application, 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 meeting the operation of the control handle and simplifying the structure of the control handle.

[0071] The technical features of the above embodiments can be combined arbitrarily. To make the description concise, 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, they should be considered to be within the scope of this specification. When the technical features in different embodiments are embodied in the same figure, it can be regarded that the figure also discloses the combination examples of the various embodiments involved.

[0072] The above embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the patent application. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present application, 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 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 structure in the second handle includes a second supporting body, which includes a partition and is provided with a guide hole. The two support rods slide into the corresponding guide holes. The second support body is also provided with a sliding locking mechanism that cooperates with the positioning teeth to maintain the relative position with the first support body. The proximal end of the support rod is provided with an anti-slip component. When the second handle slides proximally to the extreme position relative to the first handle, the anti-slip component is blocked by the partition.

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 abutment ribs in the two sets of sliding locking mechanisms are arranged at intervals, and the interval area is for the installation channel to extend through.

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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