Artificial Heart Valve Control Handle with Display Window

Abstract

The present application discloses an artificial heart valve control handle with a display window. The control handle includes a first handle and a second handle. Each handle includes a support member and a driving mechanism disposed on each support member. The support member in the first handle includes a first support body and two struts fixedly connected to the first support body and extending proximally. Two connecting sleeves are fixed at the proximal part of the first support body, and the distal parts of the respective struts are fixedly inserted into the corresponding connecting sleeves. The support member in the second handle includes a second support body. The distal part of the second support body includes two partitions arranged axially at intervals. A guiding hole is formed in each partition. The second support body is respectively provided with axially extending sliding grooves on two radially opposite sides. Each strut passes through the corresponding guiding hole and is placed in the corresponding sliding groove. The second handle as a whole slides relative to the first handle along the two struts. The cross-sectional shape of the strut is small, that is, it occupies less space and is convenient for the spatial arrangement in the second handle.

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;

[0005] 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;

[0006] 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.

[0007] The following also provides several optional methods, which are not additional limitations to the above overall solution, but merely further supplements or optimizations. On the premise of no technical or logical contradictions, each optional method can be combined with the above overall solution separately, or multiple optional methods can be combined with each other.

[0008] Optionally, the control handle is provided with an installation channel axially penetrating through the first support body and the second support body. The first support body includes:

[0009] A first main body, which is columnar and extends along the axial direction of the control handle;

[0010] A first connecting seat, fixed to the proximal end of the first main body. The two connecting sleeves are fixed to the first connecting seat and are located on both sides of the radial direction of the installation channel.

[0011] Optionally, positioning holes corresponding in position are provided on the side wall of the connecting sleeve and the distal end of the strut, and they are fixedly connected by a connecting piece passing through the positioning holes.

[0012] Optionally, the first connecting seat is a shell structure with a semi-cylindrical surface as a whole. The first support body further includes a first half shell that is snap-fitted and fixed to the first connecting seat and encloses a cylindrical shape.

[0013] Optionally, the connecting sleeve is located at the junction of the first connecting seat and the first half shell, and a snap is provided on the outer wall of the connecting sleeve for cooperation with the first half shell.

[0014] Optionally, the driving mechanism includes a base that slides axially along the control handle and a driving sleeve that is rotatably installed on the outer periphery of the corresponding support body. The driving sleeve is in screw drive with the base;

[0015] 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.

[0016] Optionally, the control handle further includes a catheter assembly connected thereto. The display window includes a first display window and / or a second display window. The first display window is used to display the deployed form of the artificial heart valve; the second display window is used to display whether the artificial heart valve finally detaches from the catheter assembly. For example, it is determined whether the artificial heart valve finally detaches from the catheter assembly by judging whether the locking rod detaches from the locking wire.

[0017] Optionally, a rotation locking mechanism is provided between the first support body and the first driving sleeve. The rotation locking mechanism includes:

[0018] A first pipe fitting, fixed to the first support body. The control handle is provided with an installation channel axially penetrating through the first support body, and a part of the installation channel extends through the inside of the first pipe fitting;

[0019] A second pipe fitting rotatably sleeved on the outer periphery of the first pipe fitting. A part of the second pipe fitting is a working section extending into the first driving sleeve, and a convex portion is provided on the outer wall of the working section;

[0020] A locking member located in the radial clearance between the working section and the first driving sleeve and configured to be able to slide radially along the first driving sleeve and act on the inner wall of the first driving sleeve. During the rotation of the second pipe fitting, the convex portion presses against the locking member to move it and correspondingly lock or unlock the first driving sleeve;

[0021] An operating member drives the second pipe fitting to rotate.

[0022] Optionally, the support rod is a metal strip, and the cross-section of the metal strip is strip-shaped and the extending direction is perpendicular to the spaced arrangement direction of the two support rods.

[0023] Optionally, an installation channel axially penetrating the first support body and the second support body is provided in the control handle. The second support body includes:

[0024] A second main body, which is columnar and extends along the axial direction of the control handle, and the sliding groove is on the side of the second main body facing away from the installation channel;

[0025] A second connecting seat includes the two partition plates and a transition portion connected between the two partition plates, and one of the partition plates is fixed to the distal end of the second main body;

[0026] A third connecting seat is fixed to the proximal end of the second main body.

[0027] Optionally, a sliding locking mechanism cooperating with the support rod is provided on the second connecting seat for maintaining the relative position between the second handle and the first handle.

[0028] Optionally, the two support rods are arranged side by side and positioning teeth are arranged on the facing sides. The sliding locking mechanism includes:

[0029] A locking member movably installed on the second support body, having a locking position engaging with the positioning teeth and an unlocking position disengaging from the positioning teeth;

[0030] An elastic member acting between the locking member and the second support body to drive the locking member towards the locking position;

[0031] An operating button is linked with the locking member to drive the locking member towards the unlocking position.

[0032] Optionally, the two partition plates include a first partition plate at the distal end and a second partition plate at the proximal end. A cover plate is buckled on the distal side of the first partition plate, and the cover plate is provided with an avoidance area corresponding to the positions of the installation channel and the guiding hole.

[0033] Optionally, a positioning rib extending radially is provided on the distal side of the first partition plate, and the cover plate is provided with a positioning groove matching with the positioning rib.

[0034] Optionally, the two partition plates extend from the positions of their respective installation channels along a first radial direction to their own edges;

[0035] The cover plate extends from the position of the installation channel along a second radial direction opposite to the first radial direction to its own edge, and forms the positioning groove.

[0036] Optionally, the proximal part of the sliding groove is the end segment extending to the outer periphery of the third connecting seat, and a mutually matching clamping structure is provided between the groove wall of the end segment and the support rod.

[0037] Optionally, the clamping structure includes:

[0038] A clamping block protruding from the groove wall of the sliding groove;

[0039] A clamping groove provided on the support rod and matching with the clamping block.

[0040] Optionally, when the second handle slides and abuts against the first handle, the clamping block is adapted to the clamping groove.

[0041] Optionally, an anti - detachment member is provided at the proximal part of the support rod. When the second handle slides relative to the first handle to the limit position towards the proximal end, the anti - detachment member is blocked by the partition plate.

[0042] Optionally, a partial area of the second main body is radially penetrated to form a guiding groove, and the driving mechanism includes:

[0043] A second base slidably arranged in the guiding groove, and the second base is used for connecting a controlled component;

[0044] A second driving sleeve rotatably sleeved on the outer periphery of the second support body, and a threaded driving fit is provided between the inner wall of the second driving sleeve and the second base.

[0045] Optionally, the transition part is a shell structure with a semi - cylindrical surface as a whole, and the second support body further includes a second half - shell buckled and fixed with the transition part to enclose a cylindrical shape.

[0046] The control handle of the present application includes a first handle and a second handle that slides relative to the first handle. The two struts serve as the support members of the first handle and also provide sliding guidance for the second handle. The structural form of the struts is more convenient for processing than the existing structure, reducing the manufacturing cost, and occupying less space inside the second handle, facilitating the structural arrangement of the second handle. The struts penetrate into the first handle and the second handle, overall improving the structural strength of the control handle. Description of the Drawings

[0047] Figure 1 It is a structural view of the control handle according to an embodiment of the present application;

[0048] Figure 2 is Figure 1 a schematic structural view of the second handle sliding relative to the first handle proximally in the control handle shown in ;

[0049] Figure 3 is Figure 1 a cross-sectional view of the control handle along its own axial direction shown in ;

[0050] Figure 4 It is a structural view of the first support body in the control handle according to an embodiment of the present application;

[0051] Figure 5 is Figure 4 an enlarged view of part B shown in ;

[0052] Figure 6 It is a structural view of the second support body in the control handle according to an embodiment of the present application;

[0053] Figure 7 It is a partial structural view of the control handle when the second handle is in the second extreme position according to an embodiment of the present application;

[0054] Figure 8 It is an exploded view of the strut and the first handle in the control handle according to an embodiment of the present application;

[0055] Figure 9 It is a structural view of the first half shell in the control handle according to an embodiment of the present application;

[0056] Figure 10 It is a front view of the control handle according to an embodiment of the present application;

[0057] Figure 11 It is an exploded view of the locking member and the half shell in the control handle according to an embodiment of the present application;

[0058] Figure 12 is Figure 11 a front view of the second pipe fitting shown in ;

[0059] Figure 13 is Figure 11Structural view of the second pipe fitting in [description];

[0060] Figure 14 is Figure 13 Structural view of the second pipe fitting in [description] from another perspective;

[0061] Figure 15 is Figure 10 Cross-sectional view of [description] in the D-D direction (when the rotation locking mechanism is in the unlocked state);

[0062] Figure 16 is Figure 10 Cross-sectional view of [description] in the D-D direction (when the rotation locking mechanism is in the locked state);

[0063] Figure 17 Exploded view of the sliding locking mechanism in the control handle of an embodiment of the present application;

[0064] Figure 18 is Figure 3 Enlarged view of part A (when the sliding locking mechanism is in the locked state) in [description];

[0065] Figure 19 Structural view of the cooperation of the engaging structure between the strut and the chute in the control handle of an embodiment of the present application;

[0066] Figure 20 is Figure 6 Partial structural view of the proximal part of the second support body in [description];

[0067] Figure 21 is Figure 7 Enlarged view of part C in [description];

[0068] Figure 22 is Figure 8 Partial structural view between the strut and the anti-disengagement member in [description];

[0069] Figure 23 Structural view of the conveying system of an embodiment of the present application;

[0070] Figure 24 is Figure 23 Enlarged view of part E in [description];

[0071] Figure 25 Partial structural view when the locking rod and the locking seat are engaged in the control mechanism of an embodiment of the present application;

[0072] Figure 26 Cross-sectional view of the catheter assembly of an embodiment of the present application;

[0073] Figure 27 Schematic diagram of the state of the conveying system of an embodiment of the present application when the distal end fully releases the artificial implant and relaxes the pulling wire;

[0074] Figure 28 Schematic diagram of the state of fully releasing the distal artificial implant and releasing the pulling wire of the conveying system according to an embodiment of the present application;

[0075] Figure 29 Structural view of the artificial implant according to an embodiment of the present application;

[0076] Figure 30 is Figure 29 Partial view at the perileakage prevention component in

[0077] The descriptions of the reference numerals in the figure are as follows:

[0078] 100, artificial implant; 110, stent; 111, grid structure; 112, inflow side; 120, valve leaf; 130, perileakage prevention component; 140, inner membrane; 150, blood flow channel;

[0079] 200, catheter assembly; 210, inner core; 211, threading channel; 220, wire control tube; 230, inner sheath tube; 240, outer sheath tube; 250, sheath;

[0080] 31, lock seat; 32, lock rod; 33, pulling wire;

[0081] 400, control handle; 401, proximal end; 402, distal end; 403, installation channel; 404, first display window; 405, second display window;

[0082] 41, first handle; 410, first support body; 4102, first guide groove; 411, first main body; 412, first connection seat; 414, first half shell; 415, buckle; 416, limiting rib;

[0083] 42, second handle; 420, second support body; 421, second main body; 4211, third chute; 4212, second guide groove;

[0084] 422, second connection seat; 4221, partition; 4221a, first partition; 4221b, second partition; 4222, guiding hole; 4223, transition part; 4225, positioning rib;

[0085] 423, third connection seat; 4231, clamping block;

[0086] 424, cover plate; 4241, avoidance area; 4242, positioning groove; 425, second half shell;

[0087] 431, locking part; 432, elastic part; 433, operating button;

[0088] 440, connecting sleeve; 441, positioning hole; 442, connecting part;

[0089] 450. Strut; 4501. Card slot; 4502. Positioning tooth; 451. Anti - detachment part; 4511. Nut; 4512. Screw rod; 452. Support bar; 4521. Installation groove; 453. Rack

[0090] 461. First pipe fitting; 462. Second pipe fitting; 4621. Working section; 4622. Protrusion

[0091] 463. Locking part

[0092] 481. First drive sleeve; 482. Second drive sleeve; 483. Third drive sleeve

[0093] 491. First base; 492. Second base; 493. Third base Detailed implementation manners

[0094] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present application.

[0095] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or there may also be an intermediate component. When a component is considered to be "disposed on" another component, it can be directly disposed on the other component or there may be an intermediate component at the same time.

[0096] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the technical field to which this application belongs. The terms used in the description of this application herein are only for the purpose of describing specific embodiments and are not intended to limit this application. The term "and / or" used herein includes any and all combinations of one or more of the related listed items.

[0097] In this application, terms such as "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly specifying the quantity or order of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of this application, the meaning of "a plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0098] This specification describes an artificial implant and a delivery system for delivering the artificial implant into a subject's body. The delivery system includes a control handle and a catheter assembly. The control handle can be connected to and control the catheter assembly for performing an interventional procedure. The catheter assembly includes a plurality of controlled members. The distal ends of the respective controlled members cooperate with each other to operate the artificial implant, such as releasing, retrieving, locking the position, adjusting the spatial attitude, etc. Each controlled member itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms. There are multiple controlled members, and at least two of them (taking the proximal end as an example) can slide relative to each other along the axis or rotate relative to each other around the axis.

[0099] The artificial implant can be an artificial heart valve or a vascular stent, etc. The artificial heart valve can include a stent and leaflets connected to the stent for controlling the blood flow on and off. The number of leaflets is generally two or three. According to needs, a skirt design can also be added to the inner side and / or the outer side of the stent. The stent itself can be formed by weaving or tube cutting. The artificial heart valve can be used to replace a diseased valve in the heart, such as the aortic valve.

[0100] In the following text, when indicating directions, the proximal end in the text generally refers to the side adjacent to the operator (such as a doctor), and the distal end is the relatively far side. Along the interventional path, each component itself has a relative distal end and proximal end; theoretically, when the catheter assembly and the control handle are completely straightened, the straight line between the proximal end and the distal end determines the axis, and correspondingly, the radial direction perpendicular to the axis and the circumferential direction arranged around the axis are also determined; when referring to a structure, the "end" in the text represents the end point of the structure or a certain point or a certain area in the side direction or the specific structure connected to this point or this area.

[0101] Refer to Figure 1 、 Figure 2 and Figure 23 , the present application provides a delivery system for an artificial implant, having opposite distal end 402 and proximal end 401. The delivery system includes a control handle 400 and a catheter assembly 200 proximally connected to the control handle 400. The artificial implant 100 is connected to the distal end of the catheter assembly 200 and is controlled by the control handle 400. As Figures 1 - 7As shown, the control handle 400 has the same distal end 402 and proximal end 401 as the delivery system. The control handle 400 includes a first handle 41 and a second handle 42. The first handle 41 is located at the distal end of the second handle 42. Each handle includes a support member and a drive mechanism provided on its respective support member. The drive mechanism has multiple groups, and each group is connected to the catheter assembly to control the control mechanism located at the distal end of the catheter assembly to complete actions such as expansion, release, and recovery of the artificial implant. The support member is used to provide a basis for the installation and movement of the drive mechanism and / or another handle, as well as structural support for the corresponding handle. The drive mechanism includes a base that slides axially along the control handle and a drive sleeve rotatably mounted on the outer periphery of the corresponding support body. The drive sleeve is in threaded transmission with the base.

[0102] The support member in the first handle 41 includes a first support body 410 and two struts 450 fixedly connected to the first support body 410 and axially extending proximally. Two connecting sleeves 440 are fixedly connected to the proximal part of the first support body 410. The distal parts of the respective struts 450 are fixedly inserted into the corresponding connecting sleeves 440, and the fixing method between the two can be snap connection or connection by fasteners.

[0103] The support member of the second handle 42 includes a second support body 420. The distal part of the second support body 420 includes two partition plates 4221 arranged axially at intervals. A guiding hole 4222 is formed in each partition plate 4221. Third sliding grooves 4211 extending axially are respectively provided on the two radially opposite sides of the second support body 420. Each strut 450 passes through the corresponding guiding hole 4222 and is placed in the corresponding third sliding groove 4211. The second handle 42 as a whole slides relative to the first handle 41 along the two struts 450 and has two limit positions of approaching / leaving the first handle 41, which are respectively Figure 1 as shown, the first limit position where the second handle 42 abuts against the first handle 41, and Figure 2 as shown, the second limit position where the second handle 42 is away from the first handle 41.

[0104] The strut is rod-shaped, which is convenient for processing and has a lower processing cost; and the optional materials are more abundant. For example, hard metal can be used, thereby improving the structural strength of the support member of the first handle and improving the connection stability between the first handle and the second handle, that is, the strut is not easily broken when the second handle is away from the first handle.

[0105] In addition, in order to ensure the sliding stability of the second handle, two struts are provided. And due to the structural shape of the strut, its cross-sectional shape is small, occupying less space and facilitating the layout of the space inside the second handle.

[0106] Among them, the control handle 400 is provided with an installation channel 403 that axially penetrates the first support 410 and the second support 420, and the installation channel 403 is for the catheter assembly 200 to pass through. The first support 410 includes a first main body 411 and a first connection seat 412. The first main body 411 is columnar and extends axially. The first connection seat 412 is fixed to the proximal end of the first main body 411, and two connection sleeves 440 are fixed to the first connection seat 412 and are located on both sides of the radial direction of the installation channel 403. Specifically, the connection 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.

[0107] Regarding the connection between the support rod 450 and the connection sleeve 440, it is as follows:

[0108] As Figures 4 - 8 shown, the side wall (outer side in the radial direction) of the connection sleeve 440 and the distal end of the support rod 450 are provided with positioning holes 441 corresponding in position, and are fixedly connected by a connecting member 442 passing through the positioning holes 441. The connecting member 442 is, for example, a screw, and the support rod 450 is provided with a threaded hole for cooperating with the screw.

[0109] As Figures 4 - 9 shown, in an embodiment, the first connection seat 412 is generally a housing structure with a semi-cylindrical surface, and the housing structure, as part of the outer shell, can be held. The first support 410 further includes a first half shell 414 that is snap-fitted and fixed to the first connection seat 412 and encloses a cylindrical shape with the housing 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 cooperates with the first half shell 414.

[0110] 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 connection 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 in the axial direction of the control handle of the buckle 415 located on the connection sleeve 440, for example, the distal end surface of the buckle 415 in the figure.

[0111] Referring back to Figure 8 , in an embodiment, the support rod 450 includes a support bar 452 and a rack 453 with positioning teeth 4502. Among them, the support bar 452 is provided with an installation groove 4521 for installing the rack 453, and the connection manner between the rack 453 and the support bar 452 can be embedded or fixedly connected (such as bonding or welding, etc.). Among them, the installation groove 4521 is open towards the bottom side and its extension range includes the sliding stroke of the second handle 42 relative to the first handle 41.

[0112] In an embodiment, the relationship between the positioning teeth 4502 and the bottom side of the support bar 452 is as follows:

[0113] The positioning teeth 4502 protrude from the bottom side of the support bar 452;

[0114] or the positioning teeth 4502 are flush with the bottom side of the support bar 452;

[0115] or the positioning teeth 4502 are lower than the bottom side of the support bar 452.

[0116] Part of the structure of the first support 410 also serves as part of the outer shell, saving manufacturing costs and simplifying the connection method with the outer shell.

[0117] Refer back to Figure 3 and Figure 4 , in one embodiment, a partial area of the first main body 411 radially penetrates to form a first guiding groove 4102. The first connecting seat 412 is arranged on the side opposite to the notch of the first guiding groove 4102, and the two connecting sleeves 440 are arranged at 90 degrees to the notch. The driving mechanism includes:

[0118] The first base 491 is slidably arranged in the first guiding groove 4102, and the first base 491 is used to connect a controlled component (such as a catheter assembly);

[0119] The first driving sleeve 481 is rotatably sleeved on the outer periphery of the first support 410, and a threaded driving fit is formed between the inner wall of the first driving sleeve 481 and the first base 491.

[0120] As Figures 9 - 16 shown, in one embodiment, a rotation locking mechanism is arranged between the first driving sleeve 481 and the first support 410. The rotation locking mechanism includes a first pipe fitting 461, a second pipe fitting 462 and a locking member 463. It should be noted that the first pipe fitting 461 and the second pipe fitting do not belong to the catheter assembly 200, and are only approximately tubular in structural shape. Among them, the first pipe fitting 461 is fixed to the support, and the fixing method is, for example, split connection and fixation inside the handle or integrally formed with the support as part of the support. Taking the first support 410 as an example in the figure, and the first pipe fitting 461 is taken as part of the first support 410. A part of the installation channel 403 extends through the inside of the first pipe fitting 461, that is, the first pipe fitting 461 is a hollow structure for part or all of the catheter assembly 200 to pass through.

[0121] The second pipe fitting 462 is rotatably sleeved on the outer periphery of the first pipe fitting 461, and a part of the second pipe fitting 462 extends into the working section 4621 inside the first driving sleeve 481. The outer wall of the working section 4621 is provided with a protruding portion 4622. Both the first pipe fitting 461 and the second pipe fitting 462 extend along the axial direction of the control handle, and neither of them is strictly restricted to be closed in the circumferential direction, and can also be partially open in the circumferential direction. In addition, the cross-sectional shapes of both of them are not strictly restricted.

[0122] The locking member 463 is located in the radial clearance between the working section 4621 and the first driving sleeve 481, and is configured to be able to move radially and act on the inner wall of the first driving sleeve 481. During the rotation of the second pipe fitting 462, the locking member 463 is pressed via the protrusion 4622 to move it and accordingly lock or unlock the first driving sleeve 481. Among them, the protruding direction of the protrusion 4622 includes at least the radial direction.

[0123] Such as Figure 15 , when in the unlocking position, there is a movable clearance between the locking member 463 and the inner wall of the first driving sleeve 481, so as to allow the first driving sleeve 481 to be easily rotated under manual action; such as Figure 16 , when the second pipe fitting 462 rotates around the dotted line to the locking position, the locking member 463 moves along the solid arrow direction and abuts against the first driving sleeve 481, so that a large enough acting force (such as static friction force) is generated between the two, thereby restricting the rotation of the first driving sleeve 481. The structure of this device can lock the first driving sleeve 481 to any position, which is beneficial to the control of the artificial implant. Compared with the existing locking structure, the operation accuracy of the control handle is improved, and the locking operation is in place in one step, simplifying the operation steps. In addition, the locking member is installed in the radial clearance between the working section and the rotating part, making the appearance of the control handle simple, the overall shape structure convenient for holding and operating, effectively utilizing the space, and making the structure of the control handle more compact.

[0124] In one embodiment, the strut 450 is a metal strip, the cross-section of the metal strip is strip-shaped, and the extending direction on this cross-section is perpendicular to the spaced arrangement direction of the two struts 450.

[0125] Among them, the second support body 420 includes:

[0126] The second main body 421, which is columnar and extends along the axial direction, and the third chute 4211 is located on the side of the second main body 421 facing away from the installation channel 403;

[0127] The second connecting seat 422, which includes two partition plates 4221 and a transition part 4223 connected between the two partition plates 4221, and one of the partition plates 4221 is fixed to the distal end of the second main body 421;

[0128] The third connecting seat 423, which is fixed to the proximal end of the second main body 421.

[0129] The third chute 4211 is opened on the back of the second main body 421, which is convenient for observing the assembly of the strut 450. And since the strut 450 is strip-shaped, the space occupied by the second main body 421 is reduced, ensuring the structural strength of the second main body 421.

[0130] A sliding locking mechanism that mates with the support rod 450 is provided on the second connecting seat 422 for maintaining the relative position between the second handle 42 and the first handle 41. The relative positions between the control mechanism and the catheter assembly located inside the body are effectively controlled, improving the surgical safety.

[0131] As Figure 17 and Figure 18 , in one embodiment, two support rods 450 are arranged side by side, and positioning teeth 4502 are arranged on the facing sides. The sliding locking mechanism includes a locking member 431, an elastic member 432, and an operation button 433. The locking member 431 is movably installed on the second support body 420, having a locking position that engages with the positioning teeth 4502 and an unlocking position that disengages 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, driving the locking member 431 towards the locking position; the operation button 433 is linked with the locking member 431, driving the locking member 431 towards the unlocking position.

[0132] For the convenience of description, in the following embodiments, the top side and the bottom side are based on the axis of the control handle in terms of the radial distance. The side with a greater distance is the top side.

[0133] Among them, the sliding locking mechanism includes a locking member 431, an elastic member 432, and an operation button 433. The locking member 431 is movably installed on the second support body 420, having a locking position that engages with the positioning teeth 4502 and an unlocking position that disengages 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, driving the locking member 431 towards the locking position; the operation button 433 is linked with the locking member 431, driving the locking member 431 towards the unlocking position. The specific unlocking operation is as follows: applying a force to the operation button 433 manually to drive the locking member 431 to switch to the unlocking position and compress the elastic member 432; releasing the operation button 433, and the elastic member 432 acts on the locking member 431 by resetting to make it switch to the locking position. Among them, two sets of sliding locking mechanisms are configured, which act on the corresponding one support rod 450 respectively. The operation buttons 433 in the two sets are aligned with each other along the radial direction of the second handle 42 and are arranged in opposite directions.

[0134] Continue to refer to Figure 17 , in one embodiment, the two partition plates 4221 include a first partition plate 4221a at the distal end and a second partition plate 4221b at the proximal end. A cover plate 424 is buckled on the distal side of the first partition plate 4221a. The cover plate 424 is provided with an avoidance area 4241 corresponding to the positions of the installation channel 403 and the guiding hole 4222. Between the two partition plates 4221, that is, the transition part 4223 is generally a shell structure with a semi-cylindrical surface. The second support body 420 further includes a second half shell 425 that is buckled and fixed to the transition part 4223 and encloses a cylindrical shape. Among them, the cover plate 424 is buckled and fixed to the first partition plate 4221a and the second half shell 425.

[0135] A positioning rib 4225 extending radially is provided on the distal side of the first partition plate 4221a, and the cover plate 424 is provided with a positioning groove 4242 that cooperates with the positioning rib 4225. The two partition plates 4221 extend open from their respective installation channel positions along the first radial direction X to their own edges, and the cover plate 424 extends open 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.

[0136] As Figure 19 and Figure 20 shown, in an embodiment, the proximal part of the third chute 4211 is the end section extending to the outer periphery of the third connecting seat 423, and a mutually cooperating engaging structure is provided between the groove wall of the end section and the support rod 450. Specifically, the engaging structure includes:

[0137] A clamping block 4231 protruding from the groove wall of the third chute 4211;

[0138] A clamping groove 4501 provided on the support rod 450 and cooperating with the clamping block 4231. When the second handle 42 is in the first extreme position, the clamping block 4231 and the clamping groove 4501 cooperate with each other, that is, the clamping groove 4501 is adjacent to the proximal end of the support rod 450. This engaging structure only provides a certain damping. After the sliding locking mechanism is unlocked, applying a certain external force to the second handle can release the cooperation between the engaging structures. This engaging structure avoids the operator accidentally unlocking the sliding locking mechanism and causing the second handle to slide, improving the use safety.

[0139] As Figure 21 and Figure 22 shown, in an embodiment, an anti - detachment member 451 is provided at the proximal part of the support rod 450. When the second handle slides proximally relative to the first handle to the extreme position (i.e., the second extreme position), the anti - detachment member 451 is blocked by the partition plate. The anti - detachment member 451 can be integrally formed with the support rod 450 or fixedly installed separately. For example, the anti - detachment member 451 is a screw, and the screw includes a screw rod 4512 screwed into the support rod 450 and a nut 4511 protruding from the upper surface of the support rod 450. When the second handle 42 is in the second extreme position, the nut 4511 abuts against the end face of the second partition plate 4221b. During assembly, first insert the support rod 450 through the second partition plate 4221b, and then install the anti - detachment member 451.

[0140] Referring back to Figures 1 - 5 , in an embodiment, a part of the second main body 421 is radially penetrated to form a second guiding groove 4212, and the driving mechanism includes:

[0141] A second base 492 slidably disposed in the second guiding groove 4212, and the second base 492 is used to connect a controlled component (the corresponding conduit assembly);

[0142] The second driving sleeve 482 is rotatably sleeved on the outer periphery of the second support 420, and a screw driving fit is provided between the inner wall of the second driving sleeve 482 and the second base 492.

[0143] Wherein, a rotation locking mechanism for restricting the rotation of the second driving sleeve 482 is provided between the second driving sleeve 482 and the second support 420, and the rotation locking mechanism refers to the foregoing embodiment.

[0144] A third base 493 is slidably installed in the second guiding groove of the second support 420, and the second support 420 is rotatably sleeved with a third driving sleeve 483 that is in screw fit with the third base 493. To better understand the control mode of the control handle 400, the setting form of the corresponding delivery system will be described below.

[0145] Reference Figures 23 - 26 , the present application discloses that the delivery system includes:

[0146] A control handle, which can adopt the control handle 400 of the foregoing embodiment;

[0147] A catheter assembly 200, including an inner sheath 230 and an inner core 210 slidably disposed in the inner sheath 230. Wherein, a lock seat 31 is connected to the distal end of the inner sheath 230, one end of the inner core 210 is an extension section extending out of the distal end of the inner sheath 230, and the radial gap between the inner core 210 and the inner sheath 230 is a threading channel 211. A lock rod 32 is fixed to the extension section and is located on the distal side of the lock seat 31, and a pulling wire 33 is movably disposed in the threading channel 211. Among them, the lock seat 31, the pulling wire 33 and the lock rod 32 constitute the above control mechanism.

[0148] In the loaded state of the artificial implant 100, the pulling wire 33 extends out of the distal end of the inner sheath 230, passes around the artificial implant 100 and is then bound to the lock rod 32, and the lock rod 32 is inserted into the lock seat 31 to cooperate to restrict the pulling wire 33 from breaking free.

[0149] 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 pulling wire 33. The state of the pulling wire 33 can affect the movement process of the artificial implant 100, especially during the release process of the artificial implant 100, so as to realize the staged release of the artificial implant 100 through the pulling wire 33. Further, the relative movement of each pipe fitting can provide a structural basis for the full release and full recovery return journey of the artificial implant 100, thereby providing a more controllable interventional treatment process, improving the treatment effect while improving the patient experience.

[0150] At the surgical site, the surgeon usually views the release or retrieval status of the artificial implant through an image. However, the visibility of the imaging system is usually poor. To enable the surgeon to more intuitively understand the deployment or folding state of the artificial implant at the surgical site, a display window for showing the deployment or folding state of the artificial implant is provided in the control handle. For example, in one embodiment, as Figure 1 shown, the control handle is provided with a first display window 404, and the first display window 404 can be fitted with a cover plate made of a transparent material for easy observation and protection. Patterns or texts indicating the state of the artificial implant are shown on the first display window 404 or around the first display window 404. For example: the fully deployed state of the artificial implant and the folded state of the artificial implant; further, as the distal end of the first display window has a mark indicating that the stent is fully deployed and the proximal end has a mark indicating that the stent is retracted, to indicate the operation process. The first display window 404 is provided with a movable mark, such as a pointer. By observing the traveling position of the mark, the state of the deployment or folding of the artificial implant can be known. 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.

[0151] As Figure 10 shown, a second display window 405 for showing whether the locking lever 32 is disengaged from the locking wire can also be provided in the control handle. Patterns or texts indicating whether the locking lever is disengaged from the locking wire are shown on the second display window 405 or around the display window; further, the second display window 405 is provided with a movable mark, such as a pointer. By observing the traveling position of the mark, it can be known whether the locking lever is disengaged from the locking wire. The mark can be connected to the third base 493, and the movement of the mark is driven by the axial movement of the third base.

[0152] The artificial implant 100 can be an artificial heart valve or a vascular stent, etc. The artificial heart valve can include a stent and leaflets connected to the stent for controlling the blood flow on and off. The number of leaflets is generally two or three. According to needs, a skirt design can be added to the inner side and / or outer side of the stent. The stent itself can be formed by weaving or tube cutting. The artificial heart valve can be used to replace the diseased valve in the heart, especially, for example, the aortic valve.

[0153] Referring to one embodiment, the lock seat 31 is provided with a lock hole that cooperates with the locking lever 32. In the locked state, the locking lever 32 is inserted into the lock hole to restrict the movement range of the pull wire 33. Referring to one embodiment, the locking lever 32 moves with the inner core 210 and has the following positions:

[0154] Release position (refer to the appendix Figure 27 ), the locking lever 32 disengages from the lock hole to release the pull wire 33;

[0155] Locking position (refer to the appendix Figure 28 ), the locking lever 32 is inserted into the lock hole to restrict the pull wire 33.

[0156] 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 pulling wire 33 is a driving end and is connected to the wire control tube 220, and the other end of the pulling wire is a working end. In the loaded state of the artificial implant, the working end bypasses the artificial implant 100 and then cooperates with the locking rod 32. Among them, there are multiple pulling wires 33.

[0157] In one embodiment, the catheter assembly 200 further includes an outer sheath tube 240 movably sleeved outside the inner sheath tube 230, where:

[0158] The outer sheath tube 240 is proximally connected to the first base 491 of the first handle 41;

[0159] The inner sheath tube 230 is proximally fixedly connected to the distal end of the second handle 42;

[0160] The wire control tube 220 is proximally connected to the second base 492 of the second handle 42;

[0161] The inner core 210 is proximally connected to the third base 493 of the second handle 42.

[0162] In one embodiment, the catheter assembly 200 further includes a sheath 250 sleeved outside the outer sheath tube 240 and proximally fixed to the first handle 41.

[0163] During interventional surgery and in vitro simulation training, when the second handle 42 slides proximally relative to the first handle 41, it can achieve quickly retracting the distal control mechanism into the body, or adjusting the position of the artificial implant and retrieving the artificial implant.

[0164] Reference Figure 29 and Figure 30 and, the present application further provides an artificial implant 100, which has a stent 110 with a grid structure 111 and in a cylindrical shape. Inside the stent 110 is a blood flow channel 150. Multiple valve leaflets 120 inside the stent cooperate with each other in the blood flow channel to relatively open or close the blood flow channel 150. The stent 110 has a corresponding axial direction (axis direction), a radial direction perpendicular to the axial direction, and a circumferential direction arranged around the axis. The grid structure can be understood as a cylindrical side wall with a hollowed-out area. The edge of the hollowed-out area is the frame bar enclosing the grid, and there is no strict limit on the size and specific shape of the grid. In the axial direction of the stent, there are an inflow side 112 and a relative outflow side according to the normal blood flow direction in the body. The stent itself can be processed by cutting or weaving a pipe, and corresponding materials are used according to the release method in the body (such as self-expanding or balloon-expandable).

[0165] Among them, the artificial implant 100 further includes an inner membrane 140 connected to the stent 110 and located within the blood flow channel. The inner membrane 140 is generally connected to the corresponding frame bars of the stent by sewing. The outflow side of the inner membrane 140 is joined to the inflow side of each valve leaf 120, and the joining method is, for example, sewing. The artificial implant 100 further includes a plurality of anti-peripheral leakage components 130. The plurality of anti-peripheral leakage components 130 are arranged circumferentially along the stent 110 and embedded in the grid structures 111 at corresponding positions. The plurality of anti-peripheral leakage components 130 surround and close along the circumference of the stent 110. All the grid structures in the same layer are filled and embedded by the anti-peripheral leakage components 130. The anti-peripheral leakage components protrude outward from the corresponding grid structures and are used to interact with the surrounding tissues in the body to prevent blood flow from passing through the periphery of the artificial implant. The anti-peripheral leakage component 130 is connected to the inner membrane 140, and the two are fixed by at least one of bonding, hot melting, sewing, infiltration or dip coating.

[0166] For the control handle of the present application, the strut is rod-shaped, which is more convenient for processing and has a lower processing cost; and the optional materials are more abundant. For example, hard metal can be used, thereby improving the structural strength of the support member of the first handle and improving the connection stability between the first handle and the second handle, that is, the strut is not easily broken when the second handle is far from the first handle.

[0167] In addition, in order to ensure the sliding stability of the second handle, two struts are provided. And due to the structural shape of the strut, its cross-sectional shape is small and occupies less space, which is convenient for arranging the space inside the second handle.

[0168] The technical features of the above embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combinations of these technical features do not conflict, they should be considered as the scope described in this specification. When the technical features in different embodiments are shown in the same drawing, it can be regarded that the drawing also discloses the combination examples of the respective embodiments involved.

[0169] The above embodiments only represent several implementation manners of the present application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several deformations and improvements can still be made, and these all belong to the protection scope of the present application.

Claims

1. An artificial heart valve control handle 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 strip-shaped support rods fixedly connected to the first support body and extending toward 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 support member in the second handle includes a second support body, the distal end of the second support body includes two partitions arranged in an axial direction at intervals, each partition is provided with a guide hole, and the second support body is provided with a third slide groove extending in the axial direction on two radially opposite sides, each support rod passes through the corresponding guide hole and is placed in the corresponding third slide groove, and the second handle as a whole is slidably matched with the first handle along the two support rods; 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, the third slide groove is located on the side of the second body facing away from the installation channel, and a partial area of ​​the second body is radially penetrated to form a guide groove; 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 driving mechanism comprises: 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.

2. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The first support body comprises: 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 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.

7. 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.

8. The artificial heart valve control handle with a display window according to claim 1, characterized in that: The second support body further comprises: The third connecting seat is fixed to the proximal end of the second body.

9. The artificial heart valve control handle with a display window according to claim 8, 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.

10. The artificial heart valve control handle with a display window according to claim 9, characterized in that: The two support rods are arranged side by side and the two sides facing each other are provided with positioning teeth. The sliding locking mechanism is arranged between the two partitions. 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.

Images