Control handle of artificial implant

Abstract

The control handle of the artificial implant comprises a supporting body and a driving mechanism, the supporting body comprises two rigid strips arranged side by side, and a guide channel is defined between the two rigid strips; at least two sets of driving mechanisms respectively comprise a transmission part and a driving sleeve, wherein the transmission part is arranged on the guide channel in a sliding manner, and the driving sleeve is rotationally arranged on the periphery of the supporting body in a sleeving manner and is in threaded fit with the transmission part. The structure of the two rigid strips arranged side by side simplifies the structure and is convenient to process and manufacture while ensuring the self structure, and particularly, the lengths of the rigid strips can be directly prolonged when parts are increased. And other parts and the assembly mode thereof are singly modularized, so that the assembly error rate is reduced, and the product percent of pass is improved.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular to a control handle for an artificial implant. Background Art

[0002] Artificial implants have been used to treat heart valve disorders. Common treatments generally include repairing or replacing the valve through surgery, or using a flexible catheter to intervene and implant an artificial implant.

[0003] In interventional technology, artificial implants are generally delivered into the body through a delivery system, and a series of operations such as expansion and release are completed through a control handle. The control handle includes a support body and various drive parts installed on the support body, a transmission part connected to a flexible catheter, and other parts. As a result, the existing support body must consider its own structural strength and the connection with other parts, and the support body is mostly formed by injection molding. Different artificial implants have different movement changes in the body, which are reflected in different operating steps and operation sequences at the control handle. This may cause the position of the parts relative to the support body to change, or the number of parts to increase. The support body needs to be re-molded, which significantly increases the cost of design and manufacturing, and increases the types of assembly, which is bound to increase the error rate and reduce the pass rate. Summary of the invention

[0004] The present application provides a control handle for an artificial implant, which saves costs and is convenient to produce, manufacture and assemble.

[0005] The present application also provides a control handle for an artificial implant, comprising:

[0006] A support body, comprising two rigid bars arranged side by side, wherein a guide channel is defined between the two rigid bars;

[0007] The driving mechanism is configured with multiple sets, wherein at least two sets of the driving mechanism respectively include a transmission member slidably mounted on the guide channel, and a driving sleeve rotatably sleeved on the outer periphery of the support body and threadedly matched with the transmission member.

[0008] 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.

[0009] Optionally, the length of the two rigid bars accounts for at least 75% of the total length of the control handle.

[0010] The present application also provides a control handle for controlling a catheter assembly, wherein the catheter assembly comprises a first group and a second group movably sleeved from the outside to the inside, and the control handle comprises:

[0011] a first handle, the first handle being used to connect the first group;

[0012] a second handle, the second handle being used to connect the second group;

[0013] The first handle and the second handle each include a support body, each of the support bodies including two rigid bars arranged side by side.

[0014] Optionally, the rigid strip is a metal strip.

[0015] Optionally, a plurality of weight-reducing holes are provided on the rigid bar.

[0016] Optionally, the rigid bar has a block that engages with the first handle and / or the second handle.

[0017] Optionally, the control handle includes a mounting seat fixedly connected to the rigid bar, and the drive sleeve is sleeved on the support body and rotatably cooperates with the mounting seat.

[0018] Optionally, the driving sleeve includes an operating portion and a docking portion embedded in the mounting seat along its own axial direction, and the mounting seat separates the operating portions of two adjacent driving sleeves from each other.

[0019] The present application also provides a control handle for controlling a catheter assembly, wherein the catheter assembly comprises a first group and a second group movably sleeved from the outside to the inside, wherein the control handle comprises:

[0020] a first handle, the first handle being used to connect the first group;

[0021] a second handle, the second handle being used to connect the second group;

[0022] Among them, the first handle is equipped with a sliding seat and a driving sleeve located on the outer periphery of the sliding seat and threadedly transmitted with the sliding seat; the far end of the second handle is provided with a connecting sleeve, the connecting sleeve and the sliding seat are rotationally matched, and a mutually matched rotation locking mechanism is provided between the two.

[0023] Optionally, the rotation locking mechanism includes:

[0024] Engaging teeth, located on the end surface of the proximal end side of the sliding seat and distributed around the rotation axis of the connecting sleeve;

[0025] An unlocking member, movably mounted on the connecting sleeve, having a locking position matched with the meshing teeth, and an unlocking position after being radially separated from the meshing teeth;

[0026] A driving member acts on the unlocking member to drive the unlocking member to remain in the locking position.

[0027] Optionally, the proximal end portion of the unlocking member itself is swingably mounted on the connecting sleeve, the connecting sleeve is provided with an operating window, and at least a portion of the unlocking member is exposed to the operating window.

[0028] Optionally, the unlocking members are arranged in pairs along the radial direction of the connecting sleeve, and the driving member is elastically compressed between the same pair of unlocking members.

[0029] Optionally, a radially extending guide groove is provided on an inner wall of the connecting sleeve, and at least a portion of the unlocking member moves along the guide groove.

[0030] Optionally, a guide step is provided in the connecting sleeve, and the unlocking member cooperates with the guide step and is radially guided inward by the guide step to have a tendency to move toward the unlocking position.

[0031] Optionally, the tooth shape of the meshing teeth is triangular.

[0032] Optionally, the unlocking member includes:

[0033] A pressing portion, exposed to the operation window;

[0034] A swing shaft, located at the proximal side of the pressing portion;

[0035] A guide portion, located at the distal end side of the pressing portion and cooperating with the guide groove;

[0036] The locking portion is located at the distal end side of the guide portion and meshes with the meshing teeth. The locking portion is tapered as a whole and converges toward the distal end.

[0037] Optionally, at least a portion of the unlocking member is exposed to the connecting sleeve, and the exposed portion is exposed to the first handle or is received inside the first handle as the second handle moves axially.

[0038] The control handle of the artificial implant of the present application has a support body of two rigid strips arranged side by side, which simplifies the structure while ensuring its own structure, making it easy to process and manufacture. In particular, when adding parts, the length of the rigid strip can be directly extended, reducing the number of molds and manufacturing costs. In addition, the way to assemble other parts with it is modularized, reducing the assembly error rate and improving the product qualification rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1a This is a structural view of an artificial implant according to an embodiment of the present application;

[0040] Figure 1b This is a structural view of a control handle according to an embodiment of the present application;

[0041] Figure 2This is a structural view of a control handle according to an embodiment of the present application;

[0042] Figure 3 for Figure 2 Exploded view of;

[0043] Figure 4 for Figure 3 A schematic diagram of the structure of the middle support body;

[0044] Figure 5 It is a structural schematic diagram of the connection between the support body and the mounting seat;

[0045] Figure 6 for Figure 2 A schematic diagram of the connection between the first handle, the second handle and the support body;

[0046] Figure 7 for Figure 2 A partial cross-sectional view of the second handle;

[0047] Figure 8 A schematic diagram of the structure of the pull wire, the locking piece and the base at the distal end of the control handle of the present application in cooperation with the artificial implant;

[0048] Fig. 9 for Figure 8 A schematic diagram of the structure of the pull wire being separated from the locking element after the middle pull wire is separated from the locking element;

[0049] Fig.10 This is a structural view of a control handle according to an embodiment of the present application;

[0050] Fig.11 for Fig.10 Middle A enlarged view;

[0051] Fig.12 for Fig.10 Side view of the central control handle removing the artificial implant;

[0052] Fig.13 for Fig.12 Partial cross-section along the BB direction;

[0053] Fig.14 An exploded view of a control handle according to another embodiment of the present application;

[0054] Fig.15 for Fig.14 An exploded view of a first handle, a second handle, a first support body, and a second support body of a control handle;

[0055] Fig.16 for Fig.14 A partial cross-sectional view of a control handle at a connection between a first handle and a second handle;

[0056] Fig.17 for Fig.14 An exploded view of the first handle and the support body;

[0057] Fig.18 for Fig.17 A schematic diagram of the connection between the first support body and the sliding seat;

[0058] Fig.19 for Fig.18 Structural view of one of the petals of the middle sliding seat;

[0059] Fig. 20 An exploded view of a control handle according to another embodiment of the present application;

[0060] Fig.21 for Fig.19 An exploded view between the distal end portion of the second handle and the second support body;

[0061] Fig. 22 for Fig.21 A schematic diagram of the structure of the unlocking part;

[0062] Fig.23 for Fig. 20 A half-section view of the middle unlocking member and the sliding seat engaging to limit the rotation of the second handle relative to the first handle;

[0063] Fig.24 for Fig.23 A half-section view showing the release of the unlocking member and the engagement of the sliding seat;

[0064] Fig.25 for Fig.21 Structural view of the component with the operating window;

[0065] Fig.26 for Fig.25 A structural view of a component with an operating window from another perspective;

[0066] Fig. 27 for Fig.24 A cross-sectional view of

[0067] Fig.28 A cross-sectional view of the end of a control handle at a force-applying component according to an embodiment of the present application;

[0068] Fig.29 for Fig.28 A cross-sectional view of the force-applying component extending proximally from the second handle;

[0069] Fig.30 An exploded view of a fourth transmission member and a force-applying member according to an embodiment of the present application;

[0070] Fig.31 for Fig.30 A half-section view of the middle operating section;

[0071] Fig.32 An exploded view of a transmission member according to an embodiment of the present application;

[0072] Fig.33 This is a structural view of a transmission member according to an embodiment of the present application;

[0073] Fig.34 An exploded view of a transmission member according to another embodiment of the present application;

[0074] Fig.35 for Fig.34 An exploded view of the transmission components from another perspective.

[0075] The reference numerals in the figures are described as follows:

[0076] 10. base; 101. locking area; 11. pull wire; 111. free end; 13. locking piece; 21. first axis; 23. second axis; 25. third axis; 211. loading section;

[0077] 3. Control handle; 31. Proximal end; 32. Distal end;

[0078] 310, first handle; 320, second handle;

[0079] 330, support body; 331, first support body; 332, second support body; 333, rigid bar; 334, guide channel; 335, block; 336, weight-reducing hole; 337, slot;

[0080] 340, transmission member; 3401, body; 3402, first half body; 3403, second half body; 3404, through hole; 3405, fixing member; 3406, threaded transmission tooth; 3407, elastic buckle; 3408, groove; 3409, slot; 3410, positioning key;

[0081] 341, first transmission member; 342, second transmission member; 343, third transmission member; 344, fourth transmission member; 345, sliding seat; 3451, meshing teeth; 3452, collar; 346, unlocking member; 3461, base; 3462, guide groove; 3463, pressing portion; 3464, swing shaft; 3465, guide portion; 3466, locking portion;

[0082] 347, driving member; 348, operating window; 3491, fixing hole;

[0083] 350, driving sleeve; 351, first driving sleeve; 352, second driving sleeve; 353, third driving sleeve; 354, fourth driving sleeve; 355, force-applying member; 3551, operating section; 3552, connecting section; 3553, first section; 3554, diameter-enlarging section; 3555, engaging portion; 3556, elastic buckle;

[0084] 356, driving ring; 3561, operating part; 3562, docking part; 357, first locking ring; 358, second locking ring;

[0085] 360, mounting seat; 361, first mounting seat; 362, second mounting seat; 363, third mounting seat; 364, connecting sleeve; 3641, base; 3462, guide step;

[0086] 37, bending drive mechanism; 371, winding wheel; 3711, ratchet; 372, knob; 374, limiter; 3741, ratchet; 375, elastic member; 376, dial button;

[0087] 38. Telescopic components;

[0088] 4. Catheter assembly; 43. Adjustable sheath tube;

[0089] 60. Artificial implant; 61. Internal frame; 63. Arm. DETAILED DESCRIPTION

[0090] 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.

[0091] 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.

[0092] 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.

[0093] 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.

[0094] This 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 interventional surgery, wherein the catheter assembly includes a plurality of control components, wherein the distal ends of the control components cooperate with each other to operate the artificial implant, such as release, recovery, locking position, adjusting spatial posture, etc., wherein each control component itself can be a hollow tube, a solid rod, a flexible wire, or a combination of multiple forms, wherein there are multiple control 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. The force-applying component (the part that the user directly operates and contacts) on the control handle used to operate each control component can be directly fixedly transmitted to the corresponding control component, or can be transmitted by means of threads, gear racks, etc.

[0095] In the following, various improvements on the control handle or local structure can be implemented on the same control handle without obvious technical contradictions, but are not strictly limited to being implemented on the same control handle. For different numbers of controlled components and movement characteristics, or for control handles with further simplified structures, the various embodiments can also be implemented separately or in appropriate combination.

[0096] There are no strict restrictions on the application site and structure of artificial implants. In some drawings or texts, an artificial heart valve is taken as an example. The artificial heart valve generally includes a deformable stent and leaflets connected to the stent. The stent is cylindrical as a whole, and the side wall is a hollow grid structure. Unless otherwise stated, the shape or size of the grid structure is not strictly limited. The inside of the stent is a blood flow channel, and the multiple leaflets cooperate with each other to control the degree of opening and closing of the blood flow channel in the stent. In order to position it in the body, a positioning structure that can interact with the surrounding native tissue, such as anchor spikes, arms, etc., can be set on the periphery of the stent. In order to prevent peripheral leakage, a skirt or anti-peripheral leakage material can be set on the inner and / or outer sides of the stent.

[0097] Depending on the expansion mode, the corresponding material is selected during the processing of the stent, such as nickel-titanium alloy with shape memory that can self-expand in the body, or stainless steel that can expand by balloon expansion, etc. The stent itself can be formed by cutting tubes or weaving wires, and the leaflets can be connected to the stent by sewing, bonding or integral mold molding.

[0098] Taking the self-expanding stent as an example, its expansion and retraction can be controlled by a sheath wrapped around the stent. The position of the stent exposed to the sheath is different and it can be controlled accordingly. It can also be controlled by a pull wire, that is, the pull wire passes through the structural gap (or wire hole structure) of the stent. The expansion degree of the stent can be changed by adjusting the tightness of the pull wire with a control handle. When the pull wire is pulled out of the stent, the stent is allowed to be completely released. Of course, the control of the pull wire is also completed through the various controlled components in the catheter assembly.

[0099] The stent of an artificial implant may generally have a connection structure that cooperates with the catheter assembly to limit the position of each other and prevent unnecessary positional displacement during transportation. The artificial implant is in a radially compressed state, i.e., a loaded state, when input, and is in an expanded state after being released from the constraints of the catheter assembly and radially expanded in the body. Unless otherwise specified, the shape of the artificial implant is understood to be in the expanded state, and the local deformation caused by the pressure of the surrounding tissue is not considered.

[0100] Due to the complexity of the structure in the body, catheter components often need to be bent. The corresponding bending parts can be in the form of tubes or wires, with the distal end acting on the bent part and the proximal end controlling the bending amplitude or direction through a control handle.

[0101] When used to indicate direction, 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 distant 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, the radial direction perpendicular to the axial direction and the circumferential direction arranged around the axial direction are also determined. When used to refer to a structure, the "end" in the text represents the endpoint of the structure, or a point or area on that side, or a specific structure connected to that point or area.

[0102] like Figure 1a and Figure 1b The present application provides a control handle 3 of an artificial implant, wherein the artificial implant 60 includes an inner frame 61, and a plurality of arms 63 are provided on the outer periphery of the inner frame, and a first gap for accommodating native tissue is formed between each arm 63 and the inner frame 61.

[0103] like Figure 2 to Figure 4 The control handle 3 has a distal end 32 and a proximal end 31 opposite to each other, and is connected to the control catheter assembly 4 to control the artificial implant 60 located at the distal end, wherein the control handle 3 includes:

[0104] The support body 330 includes two rigid bars 333 arranged side by side, and a guide channel 334 is defined between the two rigid bars 333;

[0105] The driving mechanism is configured with multiple sets, wherein at least two sets of the driving mechanism respectively include a transmission member 340 slidably mounted on the guide channel 334 , and a driving sleeve 350 rotatably sleeved on the outer periphery of the support body and threadedly matched with the transmission member 340 .

[0106] The support body adopts two rigid strip structures. On the one hand, the two radially opposite sides of the guide channel are connected, which is convenient for the radial installation of the transmission part. At the same time, the axial direction of the guide channel is also connected to meet the movement requirements of the transmission part. In addition, compared with the existing support body structure, the strip structure is more convenient to process and is not limited by materials. For example, the rigid strip 333 is a metal strip, which effectively improves the structural strength of the support body.

[0107] In addition, if the number of components of the control mechanism increases or the operation becomes complicated, for example, the number of transmission parts and drive sleeves increases, the rigid strip can be extended axially accordingly to meet the installation requirements of the redundant transmission parts and drive sleeves. The installation method between each transmission part and the support body, and between each drive sleeve and the support body is the same, realizing modular installation, without sacrificing its own structural strength to meet the installation requirements. And after the assembly method is single, the assembly error rate is reduced and the product qualification rate is improved.

[0108] In one embodiment, the length of the two rigid bars 333 accounts for at least 75% of the total length of the control handle 3, wherein the lengths of both are the lengths of the two ends along the axial direction, and the total length of the control handle is the length when the control handle is fully extended and the telescopic assembly 38 is in the second extreme position (i.e., the shortest), that is, starting from the distal end surface of the telescopic assembly and ending at the proximal end surface of the force-applying component 355 in the following embodiment.

[0109] In one embodiment, a plurality of weight-reducing holes 336 are provided on the rigid bar 333 to reduce the weight of the support body and the contact area between the support body and the transmission member, thereby reducing friction and making the movement of the transmission member smoother.

[0110] In one embodiment, the distal end of the rigid bar extends into the telescopic assembly 38, and specifically, the distal end of the rigid bar extends close to the head stage.

[0111] In another embodiment, the catheter assembly 4 includes a first group and a second group of movable sleeves from the outside to the inside, the control handle 3 includes a first handle 310 and a second handle 320, the first handle 310 is used to connect the first group, and the second handle 320 is used to connect the second group. The first handle 310 and the second handle 320 both include a support body 330, and each support body 330 includes two rigid bars 333 arranged side by side. The first handle 310 and the second handle 320 can share the same support body (such as Figure 6 ), or the support bodies of the first handle 310 and the second handle 320 are not shared. When the first handle 310 and the second handle 320 are far away from each other and the distance between them is the longest, the corresponding control handle is in a fully extended state.

[0112] like Figure 3 to Figure 7 In one embodiment, the rigid bar 333 has a block 335 that engages with the first handle 310 and / or the second handle 320. To keep the rigid bar relatively fixed to the corresponding handle, a slot 337 that cooperates with the block 335 is provided on the corresponding handle, and this cooperation method is also applicable to other components such as transmission parts. For example, when the first handle 310 and the second handle 320 are movably matched (there is a relative change in the axial and / or circumferential direction between the two handles), the rigid bar 333 is connected and fixed to one of the handles through the block 335, and is slidably matched and / or rotationally matched with the other handle.

[0113] In one embodiment, the control handle 3 includes a mounting seat 360 connected and fixed to the two rigid bars 333, and the drive sleeve 350 is inserted into the rigid bars 333 and rotates with the mounting seat 360. The mounting seat 360 is provided with a slot 337 that cooperates with the block 335, and provides a mounting base for the drive sleeve, while keeping the two rigid bars relatively fixed. The modular installation is further described here:

[0114] The mounting seat 360 includes two parts that are buckled together in the radial direction. Before installing the drive sleeve, the two parts are first buckled and fixed on the support body, and then the transmission member is inserted into the guide channel, and finally the drive sleeve is installed and combined with the transmission member. Among them, the installation direction of the mounting seat 360 and the installation direction of the transmission member do not interfere with each other, and the installation order of the two is not strictly limited, and the installation is more flexible.

[0115] The first handle 310 and the second handle 320 share a support body, wherein the second handle 320 is fixedly connected to the support body, and the second handle 320 slides relative to the first handle 310. The first group of the catheter assembly 4 includes a bending sheath 43, and the second group includes a first shaft 21, a second shaft 23 and a third shaft 25; radially from the inside to the outside, they are the first shaft 21, the second shaft 23 and the third shaft 25, the proximal end of the third shaft 25 is fixedly connected to the first handle 310, and the distal end is fixedly connected to a base,

[0116] The plurality of drive sleeves include, from the distal end to the proximal end:

[0117] The first driving sleeve 351 is used to control the movement of the telescopic assembly 38 with reference to the previous embodiment;

[0118] A second driving sleeve 352 is disposed on the first handle 310 and is used to control the second handle 320 to slide axially relative to the first handle 310;

[0119] A third driving sleeve 353, disposed on the second handle 320, for controlling the second shaft 23 to move axially;

[0120] The fourth driving sleeve 354 is disposed on the second handle 320 and is used to control the axial movement of the first shaft 21 .

[0121] The multiple transmission parts include, from far to near:

[0122] The first transmission member 341 is fixedly connected to the support body 330, fixed to the third shaft 25 and threadedly matched with the second drive sleeve 352;

[0123] The second transmission member 342 is slidably mounted in the guide channel 334, fixedly connected to the second shaft 23 and threadedly engaged with the third driving sleeve 353;

[0124] The third transmission member 343 is slidably mounted in the guide channel 334 , fixedly connected to the first shaft 21 and threadedly engaged with the fourth drive sleeve 354 .

[0125] like Figure 8 to Figure 13 The distal end of the second shaft 23 is fixedly connected with the pull wire 11, the distal end of the first shaft 21 is fixedly connected with the loading section 211, and the locking element is movably connected. The loading section 211 is open toward the proximal end, and the entire inner frame 61 or at least the distal end portion of the inner frame 61 is accommodated in the loading section 211. The base 10 is provided with a locking area 101, the pull wire 11 has a free end 111 that can be passed through or detached from the artificial implant 60, and the locking element 13 is located at the distal end of the base 10 as a whole, and the locking element 13 is rotatably matched with the base 10 to lock the free end 111 of the pull wire 11. The base 10 has a distal end 32 and a proximal end 31 opposite to each other, and an axial direction extending between the distal end 32 and the proximal end 31. The proximal end, the distal end and the axial direction are also applicable to other components of the control mechanism, as well as the control handle and the delivery system of the following embodiments without special explanation.

[0126] The free end 111 is the end of the pull wire 11 that first passes through and finally leaves the artificial implant 60, and can also be understood as the farthest end of the pull wire 11 when it is straightened; the other end of the pull wire 11 opposite to the free end 111 is the control end, which can be directly fixed to the base 10, or extend proximally and controllably.

[0127] The free end 111 has a first state (eg, Figure 8 ) and the second state of unrestricted (such as Fig. 9); the lock 13 is movably matched with the base 10, and the lock 13 is matched with the free end 111 of the pull wire 11 to switch the state of the free end 111. In the first state, the free end 111 is combined with the lock 13 and the lock 13 is matched with the base 10 to limit the pull wire 11 from being separated from the lock 13. At this time, the free end 111 can be understood as being relatively fixed to the lock 13; in this state, the pull wire 11 is always connected to the artificial implant 60, and the expansion process (i.e., the expansion degree) of the artificial implant is adjusted according to the length of the pull wire 11 exposed outside the control mechanism, and the expansion / contraction speed of the artificial implant is controlled according to the change rate of the pull wire. If necessary, the pull wire 11 can also be used to recycle the artificial implant.

[0128] In the second state, the free end 111 is disengaged from the locking element 13. At this time, the free end 111 can be understood to be released, thereby releasing the interconnection between the artificial implant and the control mechanism. Subsequently, the control mechanism can be withdrawn out of the body as a whole, leaving the artificial implant at a predetermined position in the body.

[0129] When the locking element, the base and the pull wire are preassembled in vitro, the pull wire 11 is inserted from the proximal end of the base, and then extends from the distal end of the base to pass through the artificial implant and then combine with the locking element 13 .

[0130] After releasing and disengaging the artificial implant, the driving control end makes the pull wire 11 move toward the proximal end to recycle the pull wire; when reclaiming the artificial implant, the pull wire 11 is in the first state, and the rigid strip is operated to reduce the length exposed outside the control mechanism. Among them, a linkage assembly is arranged between the loading section 211 and the locking member 13, and the linkage assembly includes two matching parts, one of which is connected to the loading section 211, and the other is connected to the locking member 13. The loading section 211 moves axially to make the two matching parts linked or disengaged. In one embodiment, after the artificial implant 60 is accurately positioned and expanded, the loading section 211 located at the distal end is first moved toward the proximal end and combined with the locking member 13. At this time, the loading section 211 is bound to be in the artificial implant 60 in the axial position, and then the first shaft 21 is rotated and the control of the pull wire 11 is released through the linkage assembly. During the rotation operation, the proximal end of the loading section 211 is not easy to or even will not interfere with the distal end of the artificial implant, for example, the loading section 211 is hung at the distal end of the artificial implant. In addition, there is no need to set a separate drive tube for the locking member, which simplifies the structure.

[0131] In one embodiment, there are multiple mounting seats 360 and they are arranged along the axial direction, and the head and tail of the driving sleeve 350 are limited by two adjacent bases and rotate with one of the bases. Specifically, the second handle 320 includes a first mounting seat 361, a second mounting seat 362 and a third mounting seat 363 from far to near, the third driving sleeve 353 is embedded in the first mounting seat 361 and is limited by the first mounting seat 361 and the second mounting seat 362, and the fourth driving sleeve 354 is embedded in the second mounting seat 362 and is limited by the second mounting seat 362 and the third mounting seat 363.

[0132] The first mounting seat 361 is disposed at the distal end of the second handle 320, and the third mounting seat 363 is disposed at the proximal end of the second handle 320. As for the structure of the drive sleeve 350 itself, the drive sleeve 350 includes a drive ring 356, and a first locking ring 357 and a second locking ring 358 connected to the axial ends of the drive ring 356, wherein the drive ring 356 is two petals that are buckled with each other, the first locking ring 357 is threadedly connected to the drive ring 356, and the second locking ring 358 is sleeved on the drive ring 356.

[0133] In one embodiment, the drive sleeve 350 includes an operating portion 3561 and a docking portion 3562 embedded in the mounting seat 360 along its own axial direction. The mounting seat 360 separates the operating portions 3561 of two adjacent drive sleeves 350 from each other to reduce the probability of misoperation.

[0134] In one embodiment, the first transmission member 341 is disposed at the distal end of the first handle 310, specifically, for example, at the distal end or proximal end of the first mounting seat 361. The first transmission member 341 is directly or indirectly connected to the support body 330, for example, the first transmission member 341 is directly and fixedly connected to the support body 330, or the first transmission member 341 is fixedly connected to the first mounting seat 361 (indirect connection).

[0135] In the figure, the first mounting seat 361 has a connecting sleeve 364 extending into the first handle 310 at the distal end, and the first transmission member 341 is disposed at the distal end of the connecting sleeve 364. The connecting sleeve 364 is fixedly connected to the support body and wrapped around the outer periphery of the support body 330, serving as a guide for the second handle to slide relative to the first handle and covering the support body.

[0136] In one embodiment, the rigidity strip has a greater width dimension in a section of the second handle than in a section of the first handle.

[0137] In another embodiment, if Figure 14 to Figure 16The first handle 310 and the second handle 320 do not share a common support body, that is, the first handle 310 includes a first support body 331, and the second handle 320 includes a second support body 332. The second handle 320 is movable relative to the first handle 310. Specifically, the second handle 320 rotates relative to the first handle 310 and slides axially. The configuration of each drive sleeve refers to the aforementioned embodiment.

[0138] The proximal end of the first handle 310 is provided with a sliding seat 345 threadedly matched with the second drive sleeve 352, the sliding seat 345 is fixedly connected to the first support body 331, the first mounting seat 361 of the second handle 320 is rotationally matched with the sliding seat 345, a clamping structure for limiting axial movement is provided between the two, and the third shaft is fixedly connected to the first mounting seat 361. The second handle 320 rotates relative to the first handle 310, so that the artificial implant at the distal end can rotate with the control mechanism to adjust the spatial posture of the artificial implant.

[0139] In the figure, the connecting sleeve 364 of the first mounting seat 361 is rotatably matched with the sliding seat 345, and the proximal end of the third shaft passes through the sliding seat 345 and is fixed in the connecting sleeve 364. The first support body 331 is fixedly connected to the sliding seat 345, and the second support body 330 is fixedly connected to the first mounting seat 361, the second mounting seat 362 and the third mounting seat (not visible in the assembled state) respectively. The distal end of the first support body 331 extends to the head of the telescopic assembly, and the proximal end of the second support body 332 extends to the connecting sleeve 364 and is close to the sliding seat 345.

[0140] The width of the rigid strip corresponding to the second support body is larger than that of the rigid strip corresponding to the first support body.

[0141] like Figure 16 to Figure 19 In one embodiment, the sliding seat 345 is composed of two petals that are interlocked and a ring 3452 that is sleeved on the outer periphery of the two petals to limit the separation of the two petals. Both petals are provided with a slot 337 that is engaged with the first support body.

[0142] like Figure 20 to Figure 27 In one embodiment, a rotating locking mechanism that cooperates with each other is provided between the sliding seat 345 and the connecting sleeve 364. The locking mechanism has:

[0143] In the locked state, the second handle 320 is restricted from rotating relative to the first handle 310, and in the unlocked state, the second handle 320 is allowed to rotate relative to the first handle 310. That is, when rotating the second handle 320, the rotation locking mechanism needs to be unlocked first to prevent misoperation.

[0144] The rotation locking mechanism comprises:

[0145] The meshing teeth 3451 are located on the end surface of the proximal end of the sliding seat 345 and are distributed around the rotation axis of the connecting sleeve 364;

[0146] The unlocking member 346 is movably mounted on the connecting sleeve 364 and has a locking position matched with the meshing teeth 3451 and an unlocking position after being radially separated from the meshing teeth 3451;

[0147] The driving member 347 acts on the unlocking member 346 to drive the unlocking member 346 to remain in the locked position. The proximal end of the unlocking member itself is swingably mounted on the connecting sleeve 364, and the connecting sleeve 364 is provided with an operating window 348, and at least a part of the unlocking member 346 is exposed to the operating window 348, which is convenient for operation and control.

[0148] In one embodiment, the unlocking members 346 are arranged in pairs along the radial direction of the connecting sleeve 364, and the driving member 347 is elastically compressed between the unlocking members 346. In the figure, the connecting sleeve 364 has a base 3461 extending axially between the two unlocking members 346, and the driving member 347, such as a spring, is elastically compressed between the unlocking member 346 and the base 3461. A guide step 3462 is provided in the connecting sleeve 364, and the unlocking member cooperates with the guide step and is radially guided inward by the guide step to have a tendency to move toward the unlocking position.

[0149] The tooth shape of the meshing tooth 3451 gradually converges toward the proximal end, such as a triangle.

[0150] In one embodiment, a radially extending guide groove 3462 is provided on the inner wall of the connecting sleeve, and at least a portion of the unlocking member 346 moves along the guide groove 3462 .

[0151] The unlocking member 346 comprises:

[0152] The pressing portion 3463 is exposed to the operation window 348;

[0153] The swing shaft 3464 is located at the proximal side of the pressing portion 3463;

[0154] The guide portion 3465 is located at the distal end of the pressing portion 3463 and cooperates with the guide groove 3462;

[0155] The locking portion 3466 is located at the distal end side of the guide portion 3465 and meshes with the meshing teeth 3451. The locking portion 3466 is tapered as a whole and converges toward the distal end.

[0156] In one embodiment, at least a portion of the unlocking member 346 is exposed to the connecting sleeve 364, and the exposed portion is exposed to the first handle 310 or is received inside the first handle as the second handle 320 moves axially. For example, when the unlocking member 346 is in the locked position, the exposed portion is flush with the outer circumference of the connecting sleeve 364, so that when the second handle 320 slides toward the distal end, the connecting sleeve 364 is received inside the first handle 310.

[0157] like Figure 28 to Figure 31 The present application also provides a control handle 3 for controlling a catheter assembly to operate an artificial implant. The catheter assembly includes a plurality of shafts that are slidably nested inside and outside. The control handle 3 includes a support body 330, a transmission member 340 disposed on the support body 330 and fixed to each shaft, and a drive sleeve 350 rotatably mounted on the support body 330 and threadedly driven with the transmission member 340. Among the plurality of shafts, the first shaft 21 is in the innermost layer. The proximal end of the first shaft 21 is connected to a fourth transmission member 344 and a force-applying member 355 that slides relative to the support body 330. The first shaft 21 slides axially so that the force-applying member 355 has a first position at least partially hidden in the support body 330, and a second position exposed outside the support body. The force-applying member 355 can drive the first shaft 21 to rotate.

[0158] In combination with the above, the force-applying member 355 is at least partially located inside the second handle when in the first position. The force-applying member 355 has an increased exposed portion when in the second position compared to the first position, which facilitates operation. When the force-applying member 355 is in the first position, the total length of the control handle 3 is shortened, which is beneficial for packaging and reduces the probability of accidental touch during initial operation.

[0159] The distal end of the first shaft 21 is set with reference to the above-mentioned embodiment, that is, after the distal end of the artificial implant is expanded and before the loading section and the locking element are combined, the force-applying component 355 is always in the first position to avoid misoperation and circumferential misalignment of the linkage structure, thereby ensuring that the loading section and the locking element can be successfully combined. Correspondingly, when the force-applying component 355 is in the second position, the loading section and the locking element are combined.

[0160] In one embodiment, the force-applying member 355 is fixedly connected to the first shaft 21 and is in transmission cooperation with the fourth transmission member, wherein the transmission cooperation between the force-applying member 355 and the fourth transmission member includes synchronous movement in the axial direction to satisfy the axial movement of the distal end of the first shaft, such as the loading section, and the force-applying member 355 rotates relative to the fourth transmission member to satisfy the operation of releasing the pull line, etc. In one embodiment, the force-applying member 355 is threadedly engaged with the fourth transmission member.

[0161] The force-applying member 355 is a cylindrical structure, including an operating section 3551 and a connecting section 3552 disposed at the distal end of the operating section 3551, and the connecting section 3552 is connected to the fourth transmission member 344. The connecting section 3552 has a first section 3553 extending into and connected to the fourth transmission member, and an enlarged diameter section 3554 connected to the proximal end of the first section, and a clamping portion 3555 that accommodates the enlarged diameter section 3554 and circumferentially cooperates with the enlarged diameter section 3554 is disposed at the distal end of the operating section 3551. The proximal end of the first shaft 21 passes through the connecting section 3552 and docks with the operating section 3551.

[0162] The outer circumference of the diameter expansion section 3554 is a polygonal structure, and the inner cavity of the clamping portion 3555 cooperates with the outer circumference of the diameter expansion section 3554 to limit the relative rotation of the operating section 3551 and the connecting section 3552. The side wall of the clamping portion 3555 is provided with an elastic buckle 3556 that abuts against the diameter expansion section 3554 to limit the connecting section 3552 from escaping from the operating section 3551. In one embodiment, the operating section 3551 has an axial sliding stroke relative to the connecting section 3552.

[0163] The connecting section 3552 is a bolt, the first section 3553 has an external thread, and the fourth transmission member has an internal thread matching therewith.

[0164] Combined with the aforementioned control mechanism, in the process of releasing the pull wire, the locking element will undergo spiral motion accompanied by axial movement toward the distal end, thereby driving the loading section and the first axial distal end connected to the loading section to move. In one embodiment, the connecting section 3552 slides axially relative to the operating section 3551. Specifically, the diameter expansion section 3554 can slide in the engaging portion 3555. In the actual process of releasing the pull wire, the operating section 3551 rotates axially in the first direction, driving the connecting section 3552 to rotate synchronously and move axially toward the distal end relative to the fourth transmission member until the operating section 3551 abuts against the proximal end of the fourth transmission member and the diameter expansion section 3554 abuts against the elastic buckle 3556, thereby limiting the rotation of the operating section. At the same time, all pull wires are released. It should be noted that the axial movement stroke of the connecting section 3552 is adapted to the axial movement stroke when the locking element rotates.

[0165] In one embodiment, the force-applying member 355 is a hollow structure, and the proximal end can be connected to a Y-type valve. The force-applying member 355 extends outward from the front portion of the distal end of the expanded artificial implant, and enters the support body 330 distally when the artificial implant is expanded. This prevents the Y-type valve from touching the control handle. At this time, the axial length of the portion of the force-applying member 355 exposed outside the support body is less than the axial length of the portion of the force-applying member 355 exposed outside the support body when in the second position. The axial size of the control handle is correspondingly reduced, which is beneficial for holding during packaging and interventional delivery.

[0166] Among them, before expanding the artificial implant, although the force-applying component 355 is exposed outside the supporting body, the loading section of the first axis connected thereto is limited by the force between the loading section and the artificial implant (such as friction, etc.), and acts in the opposite direction on the force-applying component 355 to limit its rotation, or require a larger driving force to reduce the probability of misoperation.

[0167] The other structures of the control handle refer to the above-mentioned embodiment, that is, the proximal end of the support body 330 is provided with a third mounting seat 363. In one embodiment, the third mounting seat 363 is a cylindrical structure, and its inner cavity is in clearance with the outer peripheral surface of the force-applying component 355, which serves as a sliding guide for the force-applying component.

[0168] like Figure 32 to Figure 35 This embodiment provides a transmission member 340 for connecting an interventional catheter in a control handle, including a body 3401, the body 3401 having a through hole 3404 axially penetrating and used for inserting the interventional catheter, and the body 3401 includes:

[0169] A first half body 3402, the outer wall of the first half body 3402 has threaded transmission teeth 3406;

[0170] The second half body 3403 is engaged with the first half body 3402, and the through hole 3404 is located between the first half body 3402 and the second half body 3403;

[0171] The fixing member 3405 is surrounded by the first half body 3402 and the second half body 3403. The fixing member 3405 has an interventional catheter fixing hole 3491 corresponding to the position of the through hole. The outer periphery of the fixing member 3405 and at least one of the first half body 3402 and the second half body 3403 are provided with a mutually matching anti-rotation structure.

[0172] The interventional catheter can be any of the shafts in the above embodiments, for example, including the first shaft and the second shaft, and the interventional catheter is fixedly connected to the fixing member 3405, for example, by bonding or tight fit. After the interventional catheter is connected to the fixing member, the first half 3402 and the second half 3403 are buckled together and wrap the fixing member 3405 to complete the assembly. The control handle adopts the structure of the above embodiment, that is, the assembled transmission member 340 is placed in the support body 330, and then threadedly matched with the drive sleeve through the threaded transmission teeth 3406.

[0173] In one embodiment, the through hole 3404 has a first radial direction Y and a second radial direction X which are relatively perpendicular to each other as shown in the figure, and the body 3401 has threaded transmission teeth 3406 on both sides along the first radial direction Y; the first half body 3402 and the second half body 3403 are engaged with each other along the second radial direction X. In the figure, the first half body 3402 has threaded transmission teeth 3406 on both sides of the first radial direction Y, and the integrity of the threaded transmission teeth 3406 is maintained, which is convenient for processing and maintains the matching accuracy with the drive sleeve.

[0174] In one embodiment, the first half body 3402 and the second half body 3403 are buckled with each other through an elastic buckle. In the figure, the second half body 3403 is provided with an elastic buckle 3407 extending along the second radial direction X, wherein the first half body 3402 has a groove 3408 adapted to the elastic buckle 3407, so that the two opposite sides of the body 3401 along the second radial direction are smooth planes, so as to cooperate with the rigid strips 333 on both sides.

[0175] In one embodiment, one of the first half body 3402 and the second half body 3403 is provided with a positioning slot 3409 extending along the second radial direction X, and the other is provided with a positioning key 3410 matched with the positioning slot for positioning during fastening.

[0176] In one embodiment, the anti-rotation structure is set as follows: the fixing member 3405 is an annular structure, whose inner hole is the fixing hole 3491 and has a non-circular outer contour, and the first half 3402 and the second half 3403 both have an anti-rotation inner edge that partially or completely fits the outer contour of the fixing member 3405.

[0177] The control handle of the artificial implant of the present application has a support body of two rigid strips arranged side by side, which simplifies the structure while ensuring its own structure, making it easy to process and manufacture. In particular, when adding parts, the length of the rigid strip can be directly extended, reducing the number of molds and manufacturing costs. In addition, the way to assemble other parts with it is modularized, reducing the assembly error rate and improving the product qualification rate.

[0178] 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.

[0179] 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. A control handle for an artificial implant, characterized in that: include: A support body, comprising two rigid bars arranged side by side, wherein a guide channel is defined between the two rigid bars; The driving mechanism is configured with multiple sets, wherein at least two sets of the driving mechanism respectively include a transmission member slidably mounted on the guide channel, and a driving sleeve rotatably sleeved on the outer periphery of the support body and threadedly matched with the transmission member.

2. The control handle of the artificial implant according to claim 1, characterized in that: The length of the two rigid bars accounts for at least 75% of the total length of the control handle.

3. The control handle of the artificial implant according to claim 1, characterized in that: The rigid strips are metal sheet strips.

4. The control handle of the artificial implant according to claim 3, characterized in that: The rigid bar is provided with a plurality of weight-reducing holes.

5. The control handle of the artificial implant according to claim 1, characterized in that: It comprises a mounting seat fixedly connected to the rigid bar, and the driving sleeve is sleeved on the supporting body and rotatably matched with the mounting seat.

6. The control handle of the artificial implant according to claim 5, characterized in that: The driving sleeve comprises an operating portion and a docking portion embedded in the mounting seat along its axial direction, and the mounting seat separates the operating portions of two adjacent driving sleeves from each other.

7. A control handle of an artificial implant, used to control a catheter assembly, the catheter assembly comprising a first group and a second group movably mounted from outside to inside, characterized in that: The control handle comprises: a first handle, the first handle being used to connect the first group; a second handle, the second handle being used to connect the second group; The first handle and the second handle each include a support body, each of the support bodies including two rigid bars arranged side by side.

8. The control handle of the artificial implant according to claim 7, characterized in that: The rigid bar has a clamping block that is clamped with the first handle and / or the second handle.

9. The control handle of the artificial implant according to claim 7, characterized in that: The first handle is provided with a sliding seat and a driving sleeve which is located at the periphery of the sliding seat and is threadedly driven with the sliding seat; the distal end of the second handle is provided with a connecting sleeve which is rotationally matched with the sliding seat and a mutually matched rotation locking mechanism is provided between the two.

10. The control handle of the artificial implant according to claim 9, characterized in that: The rotation locking mechanism comprises: Engaging teeth, located on the end surface of the proximal end side of the sliding seat and distributed around the rotation axis of the connecting sleeve; An unlocking member, movably mounted on the connecting sleeve, having a locking position matched with the meshing teeth, and an unlocking position after being radially separated from the meshing teeth; A driving member acts on the unlocking member to drive the unlocking member to remain in the locking position.

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