Artificial heart valve control handle with indicating window

Abstract

The invention discloses an artificial heart valve control handle with a window, the control handle comprises a first handle and a second handle, each handle comprises a support member and a driving mechanism arranged on each support member; 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, two connecting sleeves are fixed to the near end of the first supporting body, and the far end of each supporting rod is fixedly inserted into the corresponding connecting sleeve. A supporting component in the second handle comprises a second supporting body, the far-end portion of the second supporting body comprises two partition plates arranged at intervals in the axial direction, a guide hole is formed in each partition plate, sliding grooves extending in the axial direction are formed in the two sides, opposite to each other in the radial direction, of the second supporting body respectively, and each supporting rod penetrates through the corresponding guide hole and is arranged in the corresponding sliding groove. The second handle is integrally in sliding fit with the first handle along the two supporting rods. The section shape of the supporting rod is small, namely, the occupied space is smaller, and space arrangement in the second handle is facilitated.

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 with a display window. Background Art

[0002] In surgical operations, there is a delivery system for delivering artificial implants into the body. This type of delivery system includes a control handle, a shaft assembly connected to the control handle, and a control mechanism connected to the shaft assembly. The control handle controls the expansion, release, recovery, and other actions of the artificial implant by operating the shaft assembly and the control mechanism, and controls the withdrawal of the handle from the body after release. In order to complete the above actions, most existing control handles are divided into two control parts, which can at least slide relative to each other. Therefore, at least one part has a connecting sleeve that is embedded / sheathed with the other part, and the connecting sleeve is mostly made of plastic injection molding to take into account the functions of limiting the rotation of the two parts, so there are problems of high processing cost and low structural strength. In addition, the connecting sleeve occupies more space, which is not conducive to the layout of the structural space. Summary of the invention

[0003] The present application provides an artificial heart valve control handle with an indication window, wherein the handle has a catheter stroke indication window, so that the operator can intuitively learn the release state of the catheter distal implant during the operation through the indication window. In addition, the handle improves structural strength and reduces manufacturing costs.

[0004] The present application provides an artificial heart valve control handle with a display window, which has a distal end and a proximal end opposite to each other, and the control handle includes a first handle and a second handle, and each handle includes a support member and a driving mechanism arranged on the respective support member; The support member in the first handle comprises a first support body and two support rods fixedly connected to the first support body and extending to the proximal end, wherein the proximal end of the first support body is fixed with two connecting sleeves, and the distal end of each support rod is fixedly inserted into the corresponding connecting sleeve; The supporting structure in the second handle includes a second supporting body, and the distal end of the second supporting body includes two partitions arranged along the axial direction, each partition is provided with a guide hole, and the second supporting body is provided with axially extending slide grooves on two radially opposite sides, and each support rod passes through the corresponding guide hole and is placed in the corresponding slide groove. The second handle as a whole slides relative to the first handle along the two support rods.

[0005] 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.

[0006] Optionally, the control handle has a mounting channel axially penetrating the first support body and the second support body, and the first support body includes: The first body is columnar and extends axially along the control handle; The first connecting seat is fixed to the proximal end of the first main body, and the two connecting sleeves are fixed to the first connecting seat and are located on both sides of the installation channel in the radial direction.

[0007] Optionally, the side wall of the connecting sleeve and the distal end of the support rod are provided with corresponding positioning holes, and are fixedly connected by a connecting piece passing through the positioning holes.

[0008] Optionally, the first connecting seat as a whole is a shell structure with a semi-cylindrical surface, and the first supporting body also includes a first half shell that is buckled and fixed to the first connecting seat and encloses a cylindrical shape.

[0009] Optionally, the connecting sleeve is located at the junction of the first connecting seat and the first half shell, and the outer wall of the connecting sleeve is provided with a buckle that matches the first half shell.

[0010] Optionally, 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, and threaded transmission is provided between the driving sleeve and the base; The control handle is provided with a display window corresponding to at least one base, and the display window is used to observe the relative position of the base.

[0011] Optionally, the control handle further includes a catheter assembly connected thereto, and the display window includes a first display window and / or a second display window, wherein the first display window is used to display the deployment form of the artificial heart valve; and the second display window is used to display whether the artificial heart valve is finally separated from the catheter assembly. For example, whether the artificial heart valve is finally separated from the catheter assembly is displayed by judging whether the locking rod is separated from the locking line.

[0012] Optionally, a rotation locking mechanism is provided between the first support body and the first driving sleeve, and the rotation locking mechanism comprises: A first pipe member is fixed to the first support body, the control handle has a mounting channel axially penetrating the first support body, and a portion of the mounting channel extends through the first pipe member; A second pipe member, a rotatable sleeve is arranged on the outer periphery of the first pipe member, a portion of the second pipe member is a working section extending into the first driving sleeve, and an outer wall of the working section has a convex portion; a locking member, located in a radial gap between the working section and the first drive sleeve, and configured to be able to slide in a radial direction of the first drive sleeve and act on an inner wall of the first drive sleeve, so that during the rotation of the second pipe member, the locking member is pressed by the protruding portion to move and lock or unlock the first drive sleeve accordingly; The operating component drives the second pipe to rotate.

[0013] Optionally, the support rod is a metal bar, the cross-section of the metal bar is strip-shaped and the extension direction is perpendicular to the spacing arrangement direction of the two support rods.

[0014] Optionally, the control handle has a mounting channel axially penetrating the first support body and the second support body, and the second support body includes: The second body is columnar and extends axially along the control handle, and the slide groove is located on a side of the second body facing away from the installation channel; A second connecting seat, comprising the two partitions and a transition portion connected between the two partitions, wherein one partition is fixed to the distal end of the second body; The third connecting seat is fixed to the proximal end of the second body.

[0015] Optionally, the second connecting seat is provided with a sliding locking mechanism that cooperates with the support rod and is used to maintain the relative position between the second handle and the first handle.

[0016] Optionally, two support rods are arranged side by side and positioning teeth are arranged on the opposite sides, and the sliding locking mechanism includes: 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 supporting body, driving the locking member toward a locking position; The operating button is linked with the lock element to drive the lock element toward the unlocking position.

[0017] Optionally, the two partitions include a first partition at the distal end and a second partition at the proximal end, a cover plate is fastened to the distal side of the first partition, and the cover plate is provided with an avoidance area corresponding to the position of the installation channel and the guide hole.

[0018] Optionally, a distal end side of the first partition is provided with a positioning rib extending in the radial direction, and the cover plate is provided with a positioning groove cooperating with the positioning rib.

[0019] Optionally, the two partitions extend from their respective installation channel positions along the first radial opening to their own edges; The cover plate is opened from the installation channel position along a second radial direction opposite to the first radial direction and extends to its own edge to form the positioning groove.

[0020] Optionally, the proximal end portion of the slide groove is a terminal section extending to the outer periphery of the third connecting seat, and a mutually cooperating snap-fit ​​structure is provided between the groove wall of the terminal section and the support rod.

[0021] Optionally, the snap-fit ​​structure includes: A clamping block, convexly disposed on the groove wall of the sliding groove; A card slot is arranged on the support rod and matches with the card block.

[0022] Optionally, when the second handle slides and abuts against the first handle, the card block is adapted to the card slot.

[0023] Optionally, a proximal portion of the support rod is provided with an anti-slip component, and when the second handle slides proximally relative to the first handle to an extreme position of the component, the anti-slip component is blocked by the partition.

[0024] Optionally, a partial area of ​​the second body is radially penetrated to form a guide groove, and the driving mechanism includes: A second base, slidably disposed in the guide groove, the second base being used to connect to a controlled component; The second driving sleeve is rotatably mounted on the outer periphery of the second supporting body, and the inner wall of the second driving sleeve is threadedly matched with the second base.

[0025] Optionally, the transition portion as a whole is a shell structure having a semi-cylindrical surface, and the second support body further includes a second half shell that is buckled and fixed to the transition portion and forms a cylindrical shape. The control handle of the present application includes a first handle and a second handle that slides relative to the first handle. The two support rods serve as support components for the first handle and also provide sliding guides for the second handle. The structural form of the support rods is more convenient to process than the existing structure, reducing manufacturing costs, and occupies less space in the second handle, which is convenient for the structural arrangement of the second handle. The support rods extend through the first handle and the second handle, thereby improving the structural strength of the control handle as a whole. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 This is a structural view of a control handle according to an embodiment of the present application; Figure 2 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 3 for Figure 1 A cross-sectional view of the middle control handle along its own axis; Figure 4This is a structural view of a first support body in a control handle according to an embodiment of the present application; Figure 5 for Figure 4 Middle B enlarged view; Figure 6 This is a structural view of a second support body in a control handle according to an embodiment of the present application; Figure 7 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; Figure 8 An exploded view between the support rod and the first handle in a control handle according to an embodiment of the present application; Fig. 9 This is a structural view of a first half shell in a control handle according to an embodiment of the present application; Fig.10 A front view of a control handle according to an embodiment of the present application; Fig.11 An exploded view of a locking member and a half shell in a control handle according to an embodiment of the present application; Fig.12 for Fig.11 A front view of the second pipe fitting; Fig.13 for Fig.11 A structural view of the second pipe fitting; Fig.14 for Fig.13 A structural view of the second pipe member in another viewing angle; Fig.15 for Fig.10 Cross-sectional view in the middle DD direction (the rotary locking mechanism is in the unlocked state); Fig.16 for Fig.10 Cross-sectional view in the middle DD direction (rotation locking mechanism is in locked state); Fig.17 An exploded view of a sliding locking mechanism in a control handle according to an embodiment of the present application; Fig.18 for Figure 3 Enlarged view of middle section A (the slide lock mechanism is in the locked state); Fig.19 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. 20 for Figure 6 A local structural view of the proximal portion of the second support body; Fig.21 for Figure 7 Enlarged view of middle C section; Fig. 22 for Figure 8A partial structural view between the middle support rod and the anti-dropping piece; Fig.23 A structural diagram of a conveying system according to an embodiment of the present application; Fig.24 for Fig.23 Enlarged view of middle E part; Fig.25 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; Fig.26 A cross-sectional view of a catheter assembly according to an embodiment of the present application; Fig. 27 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 completely releases the artificial implant and relaxes the pull line; Fig.28 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 completely releases the artificial implant and releases the pull line; Fig.29 This is a structural view of an artificial implant according to an embodiment of the present application; Fig.30 for Fig.29 Partial view at the anti-leakage component.

[0027] 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; 211, insertion channel; 220, wire control tube; 230, inner sheath tube; 240, outer sheath tube; 250, sheath; 31. Locking seat; 32. Locking rod; 33. Pulling wire; 400, control handle; 401, proximal end; 402, distal end; 403, installation channel; 404, first display window; 405, second display window; 41, first handle; 410, first support body; 4102, first guide groove; 411, first main body; 412, first connecting seat; 414, first half shell; 415, buckle; 416, limiting rib; 42, second handle; 420, second support body; 421, second body; 4211, third slide groove; 4212, second guide groove; 422, second connecting seat; 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; 431, locking member; 432, elastic member; 433, operating button; 440, connecting sleeve; 441, positioning hole; 442, connecting piece; 450, support rod; 4501, slot; 4502, positioning tooth; 451, anti-dropping piece; 4511, nut; 4512, screw rod; 452, support bar; 4521, mounting slot; 453, rack; 461, first pipe fitting; 462, second pipe fitting; 4621, working section; 4622, raised portion; 463, locking member; 481, first drive sleeve; 482, second drive sleeve; 483, third drive sleeve; 491, first base; 492, second base; 493, third base. DETAILED DESCRIPTION

[0028] 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.

[0029] 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.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] See also Figure 1 , Figure 2 and Fig.23 The present application provides a delivery system for an artificial implant, which has a distal end 402 and a proximal end 401 opposite to each other. 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. Figure 1 to Figure 7As shown, the control handle 400 has a distal end 402 and a proximal end 401 that are the same as the conveying system. The control handle 400 includes a first handle 41 and a second handle 42, wherein the first handle 41 is located at the distal end of the second handle 42, and each handle includes a support member and a driving mechanism disposed on each support member, wherein the driving mechanism is a plurality of groups, each group being connected to a catheter assembly, and is used to control a control mechanism located at the distal end of the catheter assembly to complete the expansion, release, and recovery of an artificial implant. The support member is used to provide a base for the installation and movement of the driving mechanism and / or another handle, as well as structural support for the corresponding handle. 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 supporting body, and a threaded transmission is provided between the driving sleeve and the base.

[0036] The supporting structure in the first handle 41 includes a first supporting body 410 and two support rods 450 fixedly connected to the first supporting body 410 and extending axially toward the proximal end, wherein the proximal end of the first supporting 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 in a snap-on connection or connected by fasteners.

[0037] The supporting member of the second handle 42 comprises a second supporting body 420, the distal end of the second supporting body 420 comprises two partitions 4221 arranged at intervals along the axial direction, each partition 4221 is provided with a guide hole 4222, the second supporting body 420 is provided with third slide grooves 4211 extending along the axial direction on two radially opposite sides, each support rod 450 passes through the corresponding guide hole 4222 and is placed in the corresponding third slide groove 4211, the second handle 42 as a whole slides with respect to the first handle 41 along the two support rods 450, and has two extreme positions close to / away from the first handle 41, which are respectively as follows: Figure 1 The second handle 42 shown is abutted against the first extreme position of the first handle 41, and Figure 2 The second handle 42 is shown in a second extreme position away from the first handle 41 .

[0038] The support rod is rod-shaped, which is easy to process and has lower processing costs; and there are more optional materials, for example, hard metal can be used, thereby improving the structural strength of the supporting component of the first handle and improving the connection stability between the first handle and the second handle, that is, the support rod is not easy to break when the second handle is away from the first handle.

[0039] In addition, in order to ensure the sliding stability of the second handle, two support rods are provided. And due to the structural shape of the support rod, its cross-section is small, and the occupied space is smaller, which is convenient for the space arrangement in the second handle.

[0040] The control handle 400 has a mounting channel 403 that axially penetrates the first support body 410 and the second support body 420, and the mounting channel 403 is for the catheter assembly 200 to pass through. The first support body 410 includes a first main body 411 and a first connecting seat 412. The first main body 411 is columnar and extends axially, the first connecting seat 412 is fixed to the proximal end of the first main body 411, and two connecting sleeves 440 are fixed to the first connecting seat 412 and are located on both sides of the radial direction of the mounting channel 403. Specifically, the connecting sleeve 440 is integrally formed with the first main body 411 and the proximal end is open for the support rod 450 to be inserted.

[0041] The connection between the support rod 450 and the connecting sleeve 440 is as follows: like Figure 4~Figure 8 As shown, the side wall (radially outer side) of the connecting sleeve 440 and the distal end of the support rod 450 are provided with corresponding positioning holes 441, and are fixedly connected by a connecting member 442 passing through the positioning hole 441. The connecting member 442 is, for example, a screw, and the support rod 450 is provided with a threaded hole that cooperates with the screw.

[0042] like Figure 4~Figure 9 As shown, in one embodiment, the first connection seat 412 is a shell structure with a semi-cylindrical surface as a whole, wherein the shell structure is a part of the outer shell and can be held. The first support body 410 also includes a first half shell 414 that is fastened and fixed to the first connection seat 412 and forms a cylindrical shape with the shell structure. Among them, the connection sleeve 440 is located at the junction of the first connection seat 412 and the first half shell 414, and the outer wall of the connection sleeve 440 is provided with a buckle 415 that matches the first half shell 414.

[0043] In a preferred embodiment, the installation direction of the first half shell 414 is radial, and the inner wall of the first half shell 414 is provided with a limiting rib 416 that abuts against the connecting sleeve 440 to limit the axial movement of the first half shell 414. Specifically, after the first half shell 414 is assembled, the limiting rib 416 abuts against one end surface of the buckle 415 located on the connecting sleeve 440 along the axial direction of the control handle, such as the distal end surface of the buckle 415 shown in the figure.

[0044] Re-read Figure 8 In one embodiment, the support rod 450 includes a support bar 452 and a rack 453 with positioning teeth 4502, wherein 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.

[0045] 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.

[0046] Part of the structure of the first support body 410 also serves as part of the outer shell, which saves manufacturing costs and simplifies the connection method with the outer shell.

[0047] Re-read Figure 3 and Figure 4 In one embodiment, a portion of the first body 411 is radially penetrated to form a first guide groove 4102, the first connecting seat 412 is arranged on the opposite side of the notch of the first guide groove 4102, and the two connecting sleeves 440 are arranged at 90 degrees to the notch. The driving mechanism includes: A first base 491 is slidably disposed in the first guide groove 4102, and the first base 491 is used to connect a controlled component (such as a catheter assembly); The first driving sleeve 481 is rotatably sleeved on the outer periphery of the first supporting body 410 , and the inner wall of the first driving sleeve 481 is threadedly matched with the first base 491 .

[0048] like Figure 9~Figure 16 As shown, in one embodiment, a rotation locking mechanism is provided between the first drive sleeve 481 and the first support body 410, and the rotation locking mechanism includes a first pipe 461, a second pipe 462 and a locking member 463. It should be noted that the first pipe 461 and the second pipe do not belong to the catheter assembly 200, but are only roughly tubular in structure and shape. The first pipe 461 is fixed to the support body, and the fixing method is, for example, a split connection and fixing inside the handle or being integrally formed with the support body as a part of the support body. The figure takes the first support body 410 as an example, and the first pipe 461 is a part of the first support body 410. A part of the installation channel 403 extends through the inside of the first pipe 461, that is, the first pipe 461 is a hollow structure through which part or all of the catheter assembly 200 can pass.

[0049] The second pipe member 462 is rotatably sleeved on the outer periphery of the first pipe member 461, and a portion of the second pipe member 462 extends into the working section 4621 in the first drive sleeve 481, and the outer wall of the working section 4621 has a protrusion 4622. Both the first pipe member 461 and the second pipe member 462 extend along the axial direction of the control handle, and the two are not strictly limited to being closed in the circumferential direction, and can also be partially open in the circumferential direction. In addition, the cross-sectional shapes of the two are not strictly limited.

[0050] The locking member 463 is located in the radial gap between the working section 4621 and the first drive sleeve 481, and is configured to be able to move in the radial direction and act on the inner wall of the first drive sleeve 481. During the rotation process, the second pipe member 462 presses the locking member 463 via the protrusion 4622 to make it move and correspondingly lock or unlock the first drive sleeve 481. The protrusion direction of the protrusion 4622 includes at least the radial direction.

[0051] like Fig.15 When in the unlocked position, the locking member 463 and the inner wall of the first drive sleeve 481 have a movable gap, thereby allowing the first drive sleeve 481 to be easily rotated under human action; Fig.16 When the second tube 462 rotates around the dotted line to the locking position, the locking member 463 moves along the direction of the solid arrow to resist the first drive sleeve 481, so that a sufficiently large force (such as static friction) is generated between the two, thereby limiting the rotation of the first drive sleeve 481. The device structure can lock the first drive sleeve 481 to any position, which is conducive to the control of the artificial implant. Compared with the existing locking structure, the operating accuracy of the control handle is improved, and the locking operation is completed in one step, simplifying the operating steps. In addition, the locking member is installed in the radial gap between the working section and the rotating component, so that the appearance of the control handle is simple, the overall shape structure is convenient for holding and operation, and the space is effectively used, making the structure of the control handle more compact.

[0052] In one embodiment, the support rod 450 is a metal bar, the cross section of the metal bar is strip-shaped, and the extension direction of the cross section is perpendicular to the spacing direction of the two support rods 450 .

[0053] Wherein, the second support body 420 includes: The second body 421 is columnar and extends axially, and the third slide groove 4211 is located on a side of the second body 421 facing away from the installation channel 403; The second connecting seat 422 includes two partitions 4221 and a transition portion 4223 connected between the two partitions 4221, wherein one partition 4221 is fixed to the far end of the second body 421; The third connecting seat 423 is fixed to the proximal end of the second body 421 .

[0054] The third slide groove 4211 is provided on the back of the second body 421, so as to facilitate observation of the assembly of the support rod 450. In addition, since the support rod 450 is in a strip shape, the space occupied by the second body 421 is reduced, thereby ensuring the structural strength of the second body 421.

[0055] The second connection seat 422 is provided with a sliding locking mechanism matched with the support rod 450, which is used to maintain the relative position between the second handle 42 and the first handle 41. The relative position between the control mechanism and the catheter assembly located in the body is effectively controlled, thereby improving the safety of the operation.

[0056] like Fig.17 and Fig.18 In one embodiment, two support rods 450 are arranged side by side and the positioning teeth 4502 are arranged on the opposite sides. The sliding locking mechanism 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 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 toward the locking position; the operating button 433 is linked with the locking member 431 to drive the locking member 431 toward the unlocking position.

[0057] 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.

[0058] The sliding locking mechanism 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, driving the locking member 431 toward the locking position; the operating button 433 is linked with the locking member 431, driving the locking member 431 toward the unlocking position. The specific unlocking operation is: manually applying a force to the operating button 433 to drive the locking member 431 to switch to the unlocking position and compress the elastic member 432; releasing the operating button 433, and the elastic member 432 resets and acts on the locking member 431 to switch it to the locking position. The sliding locking mechanism is configured with two sets, each acting on a corresponding support rod 450, and the operating buttons 433 in the two sets are aligned with each other along the radial direction of the second handle 42 and arranged in opposite directions.

[0059] Continue reading Fig.17 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.

[0060] The distal end of the first partition plate 4221a is provided with a positioning rib 4225 extending in the radial direction, and the cover plate 424 is provided with a positioning groove 4242 cooperating with the positioning rib 4225. The two partition plates 4221 are opened along the first radial direction X from their respective installation channel positions to their own edges, and the cover plate 424 is opened along the second radial direction Y opposite to the first radial direction X from the installation channel position to its own edge, and the positioning groove 4242 is formed.

[0061] like Fig.19 and Fig. 20 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.

[0062] like Fig.21 and Fig. 22 As 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.

[0063] Re-read Figure 1~Figure 5 In one embodiment, a portion of the second body 421 is radially penetrated to form a second guide groove 4212, and the driving mechanism includes: A second base 492 is slidably disposed in the second guide groove 4212, and the second base 492 is used to connect the controlled component (corresponding catheter assembly); The second driving sleeve 482 is rotatably sleeved on the outer periphery of the second supporting body 420 , and the inner wall of the second driving sleeve 482 is threadedly matched with the second base 492 .

[0064] A rotation locking mechanism for limiting the rotation of the second driving sleeve 482 is provided between the second driving sleeve 482 and the second supporting body 420 . The rotation locking mechanism is referred to in the above-mentioned embodiment.

[0065] The third base 493 is slidably mounted in the second guide groove of the second support body 420, and the second support body 420 is rotatably sleeved with a third driving sleeve 483 threadedly matched with the third base 493. To better understand the control method of the control handle 400, the corresponding delivery system configuration will be described below.

[0066] refer to Figure 23~Figure 26 , the present application discloses a delivery system comprising: A control handle, which may be the control handle 400 of the above embodiment; The catheter assembly 200 includes an inner sheath tube 230 and an inner core 210 slidably disposed in the inner sheath tube 230. The distal end of the inner sheath tube 230 is connected to a lock seat 31, one end of the inner core 210 is an extension section extending from the distal end of the inner sheath tube 230, and the radial gap between the inner core 210 and the inner sheath tube 230 is a guide channel 211. The extension section is fixed with a lock rod 32, which is located at the distal end side of the lock seat 31, and a pull wire 33 is movably disposed in the guide channel 211. The lock seat 31, the pull wire 33 and the lock rod 32 constitute the above-mentioned control mechanism.

[0067] When the artificial implant 100 is in the loaded state, the pulling 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 , and the locking rod 32 is plugged and matched with the locking seat 31 to restrict the pulling wire 33 from being freed from the binding.

[0068] 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 pull wire 33. The state of the pull wire 33 can affect the movement process of the artificial implant 100, especially in the release process of the artificial implant 100, so as to realize the staged release of the artificial implant 100 through the pull 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.

[0069] At the operation site, the surgeon usually uses images to check the release or retraction status of the artificial implant, but the imaging system usually has poor visibility. In order to allow the surgeon to more intuitively understand the deployment or folding status of the artificial implant at the operation site, a display window for displaying the deployment or folding status of the artificial implant is provided in the control handle. Figure 1As shown, the control handle is provided with a first indication window 404, and the first indication window 404 can be embedded with a cover plate of transparent material for easy observation and protection. The first indication window 404 or the periphery of the first indication window 404 displays a pattern or text of the state of the artificial implant, for example: the fully expanded state of the artificial implant and the folded state of the artificial implant; further, the distal end of the first indication window carries a mark indicating that the stent is fully expanded, and the proximal end carries a mark indicating that the stent is folded, to indicate the operation progress. The first indication window 404 carries a movable mark, such as a pointer, and the state of the artificial implant being expanded or folded can be known by observing the moving position of the mark. The mark can be connected to the second base, and the movement of the mark is driven by the axial movement of the second base.

[0070] like Fig.10 As shown, the control handle may also be provided with a second indication window 405 for indicating whether the locking rod 32 is out of the locking line, and the second indication window 405 or the periphery of the indication window may display a pattern or text indicating whether the locking rod is out of the locking line; further, the second indication window 405 may be provided with a movable mark, such as a pointer, and by observing the moving position of the mark, it may be known whether the locking rod is out of the locking line. The mark may be connected to the third base 493, and the movement of the mark may be driven by the axial movement of the third base.

[0071] The artificial implant 100 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 a diseased valve in the heart, especially, for example, an aortic valve.

[0072] 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 motion of the pull wire 33. Referring to an embodiment, the lock rod 32 moves with the inner core 210 and has the following positions: Release position (see attached Fig. 27 ), the locking rod 32 is disengaged from the locking hole to release the pulling wire 33; Lock position (see attached Fig.28 ), the locking rod 32 is inserted into the locking hole to constrain the pulling wire 33.

[0073] In one embodiment, the catheter assembly 200 further includes a wire control tube 220 movably sleeved on the outside of the inner core 210, one end of the pull wire 33 is a driving end and connected to the wire control tube 220, and the other end of the pull 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 pull wires 33.

[0074] In one embodiment, the catheter assembly 200 further includes an outer sheath tube 240 movably sleeved outside the inner sheath tube 230, wherein: The outer sheath 240 has a proximal end connected to the first base 491 of the first handle 41; The inner sheath 230 has a proximal end fixedly connected to the distal end of the second handle 42; The wire control tube 220 has a proximal end connected to the second base 492 of the second handle 42; The inner core 210 is connected at its proximal end to the third base 493 of the second handle 42 .

[0075] In one embodiment, the catheter assembly 200 further includes a sheath 250 which is sleeved on the outside of the outer sheath 240 and whose proximal end is fixed to the first handle 41 .

[0076] During interventional surgery and in vitro simulation training, the second handle 42 slides proximally relative to the first handle 41 to quickly withdraw the distal control mechanism into the body, or to adjust the position of the artificial implant and recover the artificial implant.

[0077] refer to Fig.29 and Fig.30 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).

[0078] Among them, the artificial implant 100 also includes an inner coating 140 connected to the stent 110 and located in the blood flow channel. 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.

[0079] The control handle of the present application has a rod-shaped support rod, which is easier to process and has lower processing costs; and there are more optional materials, for example, hard metal can be used, thereby improving the structural strength of the support component of the first handle and improving the connection stability between the first handle and the second handle, that is, the support rod is not easy to break when the second handle is away from the first handle.

[0080] In addition, in order to ensure the sliding stability of the second handle, two support rods are provided. And due to the structural shape of the support rod, its cross-section is small and occupies less space, which is convenient for the space arrangement in the second handle.

[0081] 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.

[0082] 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 with a display window, having a distal end and a proximal end opposite to each other, characterized in that: The control handle comprises a first handle and a second handle, each handle comprises a support member and a driving mechanism arranged on the respective support member; the control handle is provided with at least one display window for displaying the movement stroke of the driving mechanism; The support member in the first handle comprises a first support body and two support rods fixedly connected to the first support body and extending to the proximal end, wherein the proximal end of the first support body is fixed with two connecting sleeves, and the distal end of each support rod is fixedly inserted into the corresponding connecting sleeve; The supporting structure in the second handle includes a second supporting body, and the distal end of the second supporting body includes two partitions arranged along the axial direction, each partition is provided with a guide hole, and the second supporting body is respectively provided with a third sliding groove extending along the axial direction on two radially opposite sides, and each support rod passes through the corresponding guide hole and is placed in the corresponding third sliding groove, and the second handle as a whole slides relative to the first handle along the two support rods.

2. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The control handle has a mounting channel axially penetrating the first support body and the second support body, and the first support body includes: The first body is columnar and extends axially along the control handle; The first connecting seat is fixed to the proximal end of the first main body, and the two connecting sleeves are fixed to the first connecting seat and are located on both sides of the installation channel in the radial direction.

3. The artificial heart valve control handle with a display window according to claim 2, characterized in that: The side wall of the connecting sleeve and the distal end of the supporting rod are provided with corresponding positioning holes, and are fixedly connected by a connecting piece penetrating through the positioning holes.

4. The artificial heart valve control handle with a display window according to claim 2, characterized in that: The first connecting seat is a shell structure with a semi-cylindrical surface as a whole, and the first supporting body also includes a first half shell that is buckled and fixed with the first connecting seat and encloses a cylindrical shape.

5. The artificial heart valve control handle with a display window according to claim 4, characterized in that: The connecting sleeve is located at the junction of the first connecting seat and the first half shell, and the outer wall of the connecting sleeve is provided with a buckle matched with the first half shell.

6. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The driving mechanism comprises a base that slides along the axial direction of the control handle and a driving sleeve that is rotatably mounted on the periphery of the corresponding support body, and threaded transmission is provided between the driving sleeve and the base; The control handle is provided with a display window corresponding to at least one base, and the display window is used to observe the relative position of the base.

7. The artificial heart valve control handle with a display window according to claim 6, characterized in that: The control handle further comprises a catheter assembly connected thereto, the display window comprises a first display window and / or a second display window, the first display window is used to display the deployment morphology of the artificial heart valve; The second indication window is used to display whether the artificial heart valve is finally separated from the catheter assembly.

8. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The support rod is a metal strip, the cross section of the metal strip is strip-shaped and the extending direction is perpendicular to the spacing arrangement direction of the two support rods.

9. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The control handle has a mounting passage axially penetrating the first support body and the second support body, and the second support body includes: The second body is columnar and extends axially along the control handle, and the third slide groove is located on a side of the second body facing away from the installation channel; A second connecting seat, comprising the two partitions and a transition portion connected between the two partitions, wherein one partition is fixed to the distal end of the second body; The third connecting seat is fixed to the proximal end of the second body.

10. The artificial heart valve control handle with a display window according to claim 9, characterized in that: The second connecting seat is provided with a sliding locking mechanism matched with the support rod, which is used to maintain the relative position between the second handle and the first handle.

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