Implant Delivery Handle, Implant System, Delivery System and Their Working Methods

Abstract

The present invention provides an implant delivery handle, an implant system, a delivery system and a working method thereof. The implant delivery handle includes: two transmission subsystems arranged along the axial direction of the catheter assembly, wherein the transmission subsystem at the distal end is connected to the proximal end of the outer tube of the catheter assembly, and the transmission subsystem at the proximal end is connected to the proximal end of the inner tube of the catheter assembly; wherein, the transmission subsystem includes a synchronous transmission device and a ratchet device, and the ratchet device is fixed on the synchronous transmission device and is used to perform safety self-locking and transmission guiding on the outer tube or the inner tube through the synchronous transmission device, so as to realize the locking of the inner tube and the outer tube in a single direction, avoid the reverse movement of the inner tube or the outer tube caused by the operator's operation error, and also realize the safety self-locking of the implant delivery handle, avoiding the uncontrolled position out of control of the inner tube or the outer tube.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly relates to an implant delivery handle, an implant system, an implant delivery system and a working method thereof. Background Art

[0002] The heart valve is a membranous structure that can open and close inside the organs of humans or certain animals. Each person's heart has four valves, namely: the aortic valve connecting the left ventricle and the aorta, the pulmonary valve connecting the right ventricle and the pulmonary artery, the mitral valve connecting the left atrium and the left ventricle, and the tricuspid valve connecting the right atrium and the right ventricle. They all act as one-way valves, allowing blood to flow in only one direction and not backflow.

[0003] With the development of social economy and the aging of the population, the incidence of valvular heart disease has increased significantly. Research shows that the incidence of valvular heart disease in the elderly population over 75 years old is as high as 13.3%. At present, traditional surgical treatment is still the preferred treatment method for patients with severe valvular lesions. However, for patients who are elderly, have multiple organ diseases, have a history of thoracotomy, and have poor cardiac function, traditional surgical treatment has high risks and high mortality rates, and some patients even have no chance of surgery.

[0004] Interventional valve implantation is a brand-new minimally invasive valve replacement technology developed internationally in recent years. Its principle is that the valve prosthesis is loaded into the delivery system and delivered into the human body through a transcatheter method to replace the originally degenerated valve, improving the patient's heart function. This technology can treat valve diseases without thoracotomy and without stopping the heart, eliminating the huge trauma caused by previous surgical thoracotomy and cardiac arrest to the patient.

[0005] The human heart structure is very complex. In particular, the mitral valve structure is more complex than the aortic valve. The shape of the mitral valve annulus is irregular, and multiple chordae tendineae in the ventricular cavity seriously interfere with the implantation and positioning of the interventional valve. Therefore, for transcatheter valve replacement surgery (including transcatheter aortic valve replacement TAVI, transcatheter mitral valve replacement TMVR, etc.), the accurate positioning of the valve stent is one of the key factors for the success of the surgery. This requires the delivery system to be able to achieve precise operations, especially the guiding transmission, self-locking and other operations of the delivery system. The inaccurate operation of the delivery system will lead to operator errors during the entire surgical process, inaccurate positioning of the valve stent, and seriously, it will lead to problems such as severe paravalvular leakage / reflux in patients. Summary of the Invention

[0006] One of the purposes of the present invention is to provide an implant delivery handle that can achieve precise operations to realize the guiding transmission, self-locking and other operations of the implant delivery system.

[0007] Another object of the present invention is to provide an implant system, a delivery system and a working method thereof, which can realize the guiding drive, self-locking and other operations of the inner tube and the outer tube, and can also realize the precise operation of the delivery system.

[0008] To solve the above problems, the present invention provides an implant delivery handle, which includes two transmission subsystems arranged along the axial direction of the catheter assembly. The transmission subsystem located at the distal end is connected to the proximal end of the outer tube of the catheter assembly, and the transmission subsystem located at the proximal end is connected to the proximal end of the inner tube of the catheter assembly.

[0009] Wherein, the transmission subsystem includes a synchronous transmission device and a ratchet device. The ratchet device is fixed on the synchronous transmission device and is used to perform safety self-locking and transmission guiding on the outer tube or the inner tube through the synchronous transmission device.

[0010] Optionally, the transmission subsystem further includes a fixing device and a handwheel. The fixing device is connected to the synchronous transmission device and is also connected to the outer tube or the inner tube; the handwheel is connected to the synchronous transmission device and is used to drive the outer tube or the inner tube to perform axial movement through the synchronous transmission device and the fixing device.

[0011] Further, the ratchet device includes a ratchet, a ratchet slider, a ratchet slider rod and a ratchet slider seat.

[0012] The ratchet slider seat is used to load the ratchet slider.

[0013] One end of the ratchet slider is elastically fixed on the ratchet slider seat, and the other end of the ratchet slider is close to the ratchet and is used to control whether the ratchet rotates and the rotation direction when it rotates.

[0014] The ratchet is fixed on the synchronous transmission device and is used to cooperate with the ratchet slider to control whether the outer tube or the inner tube performs axial movement and the direction of the axial movement; and

[0015] The ratchet slider rod is connected to one end of the ratchet slider and is used to drive the ratchet slider to rotate.

[0016] Further, the synchronous transmission device includes a driving wheel, a driven wheel and a synchronous conveyor belt. The synchronous conveyor belt is arranged on the driving wheel and the driven wheel. The driving wheel is coaxially arranged with the handwheel and rotates with the handwheel, and is used to drive the driven wheel to rotate in the same direction as the driving wheel, and drive the synchronous conveyor belt to move along the axial direction of the outer tube.

[0017] Further, the ratchet wheel and the hand wheel are coaxially arranged, and the ratchet wheel is located between the driving wheel and the hand wheel. A gear is provided on the surface of the ratchet wheel facing the hand wheel, and the other end of the ratchet slider is located in the groove of the gear.

[0018] Further, the other end of the ratchet slider has a cut surface, and a chamfered surface is provided between the groove of the gear and the teeth on both sides thereof. The ratchet slider is used to control whether the ratchet wheel rotates and the rotation direction during rotation by changing the angle between the cut surface and the chamfered surface.

[0019] Further, the chamfered surface and the cut surface are arranged in parallel so that the ratchet wheel can rotate in a single direction; or,

[0020] The chamfered surface and the cut surface are arranged non-parallel so that the ratchet wheel does not rotate.

[0021] Further, the fixing device includes a catheter fixing part, a splint fixing part and a splint. The catheter fixing part is sleeved on the proximal end of the outer tube or the proximal end of the inner tube. The splint fixing part is fixed on the catheter fixing part and faces the synchronous conveyor belt. The splint is fixed on the splint fixing part, and the synchronous conveyor belt is clamped between the splint and the splint fixing part.

[0022] In a second aspect, the present invention further provides an implant delivery system, including the implant delivery handle described above, and a catheter assembly. The catheter assembly includes an outer tube and an inner tube sleeved from outside to inside in sequence. The implant delivery handle drives the outer tube and the inner tube to perform axial movement.

[0023] In a third aspect, the present invention further provides an implant system, including the implant delivery handle, the outer tube, the inner tube, the conical head and the fixing head described above. The fixing head is arranged at the distal end of the inner tube, and the conical head is arranged at the distal end of the outer tube. The implant is compressively arranged in the distal end of the outer tube and is located between the conical head and the fixing head. The implant delivery handle drives the outer tube and the inner tube to perform axial movement to realize the loading, delivery and release of the implant.

[0024] In a fourth aspect, the present invention further provides a working method of an implant delivery system, including the implant delivery system described above. The working method includes:

[0025] Rotate the ratchet slider rod so that the cut surface of the ratchet slider and the chamfered surface of the gear are arranged non-parallel. At this time, the gear limits the ratchet slider in the groove where the ratchet slider is located, and performs safety self-locking on the inner tube or the outer tube through the synchronous transmission device;

[0026] Rotate the ratchet slider rod so that the cutting surface is parallel to the chamfered surface. At this time, the ratchet can only rotate in the first direction or the second direction, and the inner tube or the outer tube is driven and guided through the synchronous transmission device. The first direction and the second direction are opposite to each other.

[0027] Among them, the transmission subsystem located at the proximal end is connected to the inner tube, and the transmission subsystem located at the distal end is connected to the outer tube.

[0028] Compared with the prior art, the present invention has the following beneficial effects:

[0029] The present invention provides an implant delivery handle, an implant system, a delivery system and a working method thereof. The implant delivery handle includes two transmission subsystems arranged along the axial direction of the catheter assembly. The transmission subsystem located at the distal end is connected to the proximal end of the outer tube of the catheter assembly, and the transmission subsystem located at the proximal end is connected to the proximal end of the inner tube of the catheter assembly. Among them, the transmission subsystem includes a synchronous transmission device and a ratchet device. The ratchet device is fixed on the synchronous transmission device and is used to perform safety self-locking and drive guidance on the outer tube or the inner tube through the synchronous transmission device, so as to realize the locking of the inner tube and the outer tube in a single direction, realize the safety self-locking of the implant delivery handle, and avoid the uncontrolled position out-of-control of the inner tube or the outer tube.

[0030] In addition, the present invention also provides an implant system, a delivery system and a working method thereof, which can realize the precise operation of the implant delivery system and the delivery system, avoid the reverse movement of the inner tube or the outer tube caused by the operator's operation error, and thus avoid the uncontrolled position out-of-control of the inner tube or the outer tube. Brief Description of the Drawings

[0031] Figure 1 Schematic perspective view of an implant delivery system according to an embodiment of the present invention;

[0032] Figure 2 Schematic partial perspective view of an implant delivery handle according to an embodiment of the present invention;

[0033] Figure 3 For Figure 1 Enlarged schematic view of area A in

[0034] Figure 4 Schematic structural view of a first fixing device according to an embodiment of the present invention;

[0035] Figure 5 For Figure 2 Partial perspective structural view of

[0036] Figures 6a - 6fSchematic diagram of the cooperative movement of the first ratchet and the first ratchet slider according to an embodiment of the present invention.

[0037] Explanation of reference numerals:

[0038] 1 - catheter assembly; 110 - inner tube; 120 - outer tube; 130 - guide wire tube; 140 - tapered head; 150 - fixed head;

[0039] 2 - implant delivery handle; 210 - housing; 220 - fixing rod; 3 - implant;

[0040] 300 - first transfer subsystem; 310 - first fixing device; 311 - first catheter fixing part; 312 - first splint fixing part; 313 - first splint; 320 - first synchronous transfer device; 321 - first driving wheel; 322 - first driven wheel; 323 - first synchronous conveyor belt; 330 - first handwheel; 340 - first ratchet device; 341 - first ratchet; 3411, 3412 - first chamfered surface; 3413 - teeth; 3414 - groove; 342 - first ratchet slider; 3421 - first cutting surface; 343 - first ratchet slider rod; 344 - first ratchet slider seat; 3441 - first main body part; 3442 - first fixing part; 345 - first elastic member;

[0041] 400 - second transfer subsystem; 410 - second fixing device; 420 - second synchronous transfer device; 421 - second driving wheel; 422 - second driven wheel; 423 - second synchronous conveyor belt; 430 - second handwheel; 440 - second ratchet device. Detailed implementation manners

[0042] The core idea of the present invention is that, on the first aspect, there is provided an implant delivery handle, which includes two transfer subsystems arranged along the axial direction of the catheter assembly. The transfer subsystem located at the distal end is connected to the proximal end of the outer tube of the catheter assembly, and the transfer subsystem located at the proximal end is connected to the proximal end of the inner tube of the catheter assembly;

[0043] Wherein, the transfer subsystem includes a synchronous transfer device and a ratchet device. The ratchet device is fixed on the synchronous transfer device and is used for safely self - locking and driving and guiding the outer tube or the inner tube through the synchronous transfer device.

[0044] On the second aspect, there is provided an implant delivery system, which includes the implant delivery handle and a catheter assembly. The catheter assembly includes an outer tube and an inner tube sleeved from the outside to the inside in sequence. The implant delivery handle drives the outer tube and the inner tube to perform axial movement.

[0045] In a third aspect, an implant system is provided, including the implant delivery handle, an outer tube, an inner tube, a tapered head, and a fixing head. The fixing head is disposed at the distal end of the inner tube, and the tapered head is disposed at the distal end of the outer tube. The implant is compressively disposed inside the distal end of the outer tube and is located between the tapered head and the fixing head. The implant delivery handle drives the outer tube and the inner tube to perform axial movement to achieve loading, delivery, and release of the implant.

[0046] In a fourth aspect, a working method of an implant delivery system is provided, including the implant delivery system. The working method includes:

[0047] Rotate the ratchet slider rod so that the section surface of the ratchet slider and the chamfer surface of the gear are non-parallel. At this time, the gear limits the ratchet slider in the slot where the ratchet slider is located, and performs safety self-locking on the inner tube or the outer tube through the synchronous transmission device;

[0048] Rotate the ratchet slider rod so that the section surface and the chamfer surface are parallel. At this time, the ratchet rotates only in the first direction or the second direction, and drives and guides the inner tube or the outer tube through the synchronous transmission device. The first direction and the second direction are opposite to each other;

[0049] Wherein, the transmission subsystem located at the proximal end is connected to the inner tube, and the transmission subsystem located at the distal end is connected to the outer tube.

[0050] Hereinafter, an implant delivery handle, an implant system, a delivery system, and a working method thereof according to the present invention will be further described in detail. The present invention will be described in more detail below with reference to the accompanying drawings, which show preferred embodiments of the present invention. It should be understood that those skilled in the art can modify the present invention described herein and still achieve the advantageous effects of the present invention. Therefore, the following description should be understood as a broad knowledge for those skilled in the art and not as a limitation to the present invention.

[0051] For clarity, not all features of actual embodiments are described. In the following description, well-known functions and structures are not described in detail because they would obscure the present invention with unnecessary details. It should be considered that in the development of any actual embodiment, a large number of implementation details must be made to achieve the specific goals of the developer, such as changing from one embodiment to another according to the relevant system or commercial limitations. In addition, it should be considered that such development work may be complex and time-consuming, but it is only routine work for those skilled in the art.

[0052] To make the objectives and features of the present invention more obvious and understandable, the following further describes the specific embodiments of the present invention with reference to the accompanying drawings. It should be noted that the accompanying drawings are in very simplified forms and use non-precise ratios, only for conveniently and clearly assisting in explaining the objectives of the embodiments of the present invention. In this article, the term "or" is usually used in the sense of including "and / or", unless the content clearly indicates otherwise. The terms "inner", "outer", and similar expressions used in this article are only for the purpose of illustration and do not represent the only implementation. In this article, the terms "distal end" and "proximal end" are the relative orientations, relative positions, and directions of elements or actions relative to each other from the perspective of a doctor using the medical device. Although "distal end" and "proximal end" are not restrictive, generally, the "proximal end" refers to the end of the medical device close to the operator during normal operation, and the "distal end" usually refers to the end close to the patient's heart.

[0053] In addition, since the first transfer subsystem and the second transfer subsystem in the two transfer subsystems are two synchronous transfer systems with substantially the same structure, and the differences may only be in minor details, such as the length of the synchronous conveyor belt, the differences in the dimensions of the second catheter fixing part connecting the proximal end of the inner tube and the first catheter fixing part when connecting the proximal end of the outer tube, these differences do not affect the actual functions of the first transfer subsystem and the second transfer subsystem. Therefore, for simplicity and clarity, the accompanying drawings in the specification only detail the first transfer subsystem in the following embodiments, and the content in the following specific embodiments is more detailed for the first transfer subsystem than the second transfer subsystem.

[0054] Figure 1 It is a three-dimensional structure schematic diagram of an implant delivery system according to this embodiment. As Figure 1 shown, this embodiment provides an implant delivery system including a catheter assembly 1 and an implant delivery handle 2, and the implant delivery handle drives the outer tube and the inner tube to perform axial movement.

[0055] Figure 2 It is a partial three-dimensional structure schematic diagram of an implant delivery handle according to this embodiment. Figure 3 For Figure 1 the enlarged schematic diagram of area A in Figure 2 and Figure 3 shown, the catheter assembly 1 includes an outer tube 120, an inner tube 110, and a guide wire tube 130 sleeved from outside to inside in sequence, that is, the outer tube 120 is sleeved outside the inner tube 110, and the inner tube 110 is sleeved outside the guide wire tube 130. Among them, a guide wire is arranged in the guide wire tube 130.

[0056] The distal end of the catheter assembly 1 further includes a tapered head 140 and a fixing head 150. The fixing head 150 is disposed at the distal end of the inner tube 110 such that all six degrees of freedom of the fixing head 150 are restricted, and it is used to fix the implant 3. The tapered head 140 is detachably disposed at the distal end of the outer tube 120. The implant 3 is located at the distal end of the inner tube 110 and is compressed and disposed inside the tube at the distal end of the outer tube 120, and is restricted between the tapered head 140 and the fixing head 150 before being released. The implant 3 is, for example, a valve stent.

[0057] Please continue to refer to Figure 2 , the implant delivery handle 2 includes a housing 210, a fixing rod 220, a first transmission subsystem 300, and a second transmission subsystem 400. The housing 210 is an assembled closed rectangular shell. Through holes are provided on both the distal side wall and the proximal side wall of the housing 210, and the through hole on the distal side wall is disposed opposite to the through hole on the proximal side wall. The direction of the straight line segment connecting the through hole on the distal side wall and the through hole on the proximal side wall is defined as the axial direction of the housing 210. The distal end of the fixing rod 220 is fixed in the through hole on the proximal side wall. The distal end of the fixing rod 220 is connected to the proximal end of the catheter assembly 1. The catheter assembly 1 passes through the through hole on the distal side wall of the housing 210, and the distal end of the catheter assembly 1 is exposed outside the housing 210. Among them, the axial direction of the catheter assembly 1 is the same as the axial direction of the housing 210. The structures of the first transmission subsystem 300 and the second transmission subsystem 400 are the same, and a part of the first transmission subsystem 300 and a part of the second transmission subsystem 400 are disposed inside the housing 210. The housing 210 is used to protect the part of the first transmission subsystem 300 and the part of the second transmission subsystem 400 located in the housing 210.

[0058] In this embodiment, the distal end of the fixing rod 220 fixes the proximal end of the guide wire tube 130. A part of the first transmission subsystem 300 and a part of the second transmission subsystem 400 are axially disposed inside the housing 210. The first transmission subsystem 300 is located at the distal end of the second transmission subsystem 400, and the second transmission subsystem 400 is connected to the proximal end of the inner tube 110 and drives the inner tube 110 to move back and forth axially (move axially from the proximal end to the distal end or move axially from the distal end to the proximal end), and controls the transmission and guiding of the inner tube 110. The first transmission subsystem 300 is connected to the proximal end of the outer tube 120 and drives the outer tube 120 to move back and forth axially, and controls the transmission and guiding of the outer tube 120.

[0059] The first transfer subsystem 300 includes a first fixing device 310, a first synchronous transfer device 320, a first handwheel 330, and a first ratchet device 340. The first synchronous transfer device 320 includes a first driving wheel 321, a first driven wheel 322, and a first synchronous conveyor belt 323 disposed on the first driving wheel 321 and the first driven wheel 322. The first driving wheel 321 is connected to the first handwheel 330, and the first handwheel 330 drives the first driving wheel 321 to rotate, drives the first driven wheel 322 to rotate in the same direction as the first driving wheel 321, and also drives the first synchronous conveyor belt 323 to move back and forth along the axial direction of the housing 210. The first synchronous conveyor belt 323 is located on one side (such as above) of the catheter assembly 1, and the first handwheel 330 is disposed outside the housing 210.

[0060] Figure 4 It is a schematic structural diagram of the first fixing device of this embodiment. As Figure 4 shown, the first fixing device 310 is sleeved on the proximal end of the outer tube 120 and is also fixed on the first synchronous conveyor belt 323. The first fixing device 310 includes a first catheter fixing portion 311, a first splint fixing portion 312, and a first splint 313. The first catheter fixing portion 311 is sleeved on the proximal end of the outer tube 120. The first splint fixing portion 312 is fixed on the side wall of the first catheter fixing portion 311 and is disposed facing the first synchronous conveyor belt 323. The first splint 313 is fixed on the first splint fixing portion 312, and the first synchronous conveyor belt 323 is clamped between the first splint 313 and the first splint fixing portion 312, so that the first synchronous conveyor belt 323 can drive the outer tube 120 to move back and forth along the axial direction when moving through the first fixing device 310.

[0061] Figure 5 For Figure 2 partial three-dimensional structural diagram. Figures 6a - 6f It is a schematic diagram of the cooperative movement of the first ratchet and the first ratchet slider of this embodiment. As Figures 5 - 6fAs shown, the first ratchet device 340 includes a first ratchet 341, a first ratchet slider 342, a first ratchet slider rod 343, and a first ratchet slider seat 344. The first ratchet 341 is disposed on the first driving wheel 321, and the first driving wheel 321 drives the first ratchet 341 to rotate coaxially therewith. The surface of the first ratchet 341 facing the first handwheel 330 has an annular sawtooth, and the central axis of the sawtooth overlaps with the central axis of the first ratchet 341. The sawtooth has teeth 3413 and grooves 3414 between adjacent teeth. The connection surfaces of the grooves 3414 with two adjacent teeth have first chamfered surfaces 3411, 3412, and the first chamfered surfaces 3411, 3412 are flat chamfered surfaces. One end of the first ratchet slider 342 is elastically fixed on the first ratchet slider seat 344, and the other end is disposed facing the first ratchet 341, and the other end of the first ratchet slider 342 (i.e., the end facing the first ratchet 341) extends into one of the grooves 3414. The first ratchet slider seat 344 is disposed on the outer wall of the housing 210.

[0062] The first ratchet slider seat 344 includes a first main body portion 3441 and a first fixing portion 3442. The first main body portion 3441 is a cylindrical structure with one end open, and the first main body portion 3441 has a bottom facing the opening. The first ratchet slider 342 is disposed in the first main body portion 3441 and is elastically connected to the first main body portion 3441, so that the first ratchet slider 342 can elastically expand and contract along the axial direction of the first main body portion 3441. Further, there is a first elastic member 345 between the end of the first ratchet slider 342 close to the first handwheel 330 and the first main body portion 3441. The first elastic member 345 is disposed at the bottom of the first main body portion 3441 and drives the first ratchet slider 342 to elastically expand and contract along the axial direction of the first main body portion 3441 through deformation. The end of the first ratchet slider 342 away from the first handwheel 330 has a first cut surface 3421, so that the axial section of the first ratchet slider 342 is a right trapezoid.

[0063] The first fixing part 3442 is arranged at the opening, and has a first notch on the side wall of the first main body part 3441 close to the opening. This first notch enables the first ratchet slider rod 343 to be connected to the first ratchet slider 342 located in the first main body part 3441, and the first main body part 3441 is fixed to the outer shell 210 through the first fixing part 3442. This first notch is strip-shaped along the circumferential direction of the side wall of the first main body part 3441, and the circumferential length is, for example, half of the circumferential length of the side wall of the first main body part 3441, so that the first ratchet slider rod 343 can move from one end of this first notch to the other end and drive the first ratchet slider 342 to rotate in the first main body part 3441.

[0064] The first ratchet slider rod 343 is fixed to one end of the first ratchet slider 342 close to the first handwheel 330 and is located in the first notch of the first main body part 3441. The first ratchet slider rod 343 can drive the first ratchet slider 342 to rotate in the first notch so as to change the direction of the first cutting surface 3421.

[0065] As Figure 2 shown, the second conveying subsystem 400 has the same structure as the first conveying subsystem 300. Specifically, the second conveying subsystem 400 includes a second fixing device 410, a second synchronous conveying device 420, a second handwheel 430 and a second ratchet device 440. The second synchronous conveying device 420 includes a second driving wheel 421, a second driven wheel 422 and a second synchronous conveyor belt 423 arranged on the second driving wheel 421 and the second driven wheel 422. The second driving wheel 421 is connected to the second handwheel 430, and the second handwheel 430 drives the second driving wheel 421 to rotate, drives the second driven wheel 422 to rotate in the same direction as the second driving wheel 421, and also drives the second synchronous conveyor belt 423 to move back and forth along the axial direction of the outer shell 210. The second synchronous conveyor belt 423 is located on one side (such as above) of the conduit assembly 1, and the second handwheel 430 is arranged on the outer side of the outer shell 210.

[0066] The second fixing device 410 is sleeved on the proximal end of the outer tube 120 and is also fixed to the second synchronous conveyor belt 423. Since the second fixing device 410 has the same structure as the first fixing device 310, the drawings of the first fixing device 310 can be referred to, that is Figure 4, the second fixing device 410 includes a second catheter fixing part, a second splint fixing part and a second splint. The second catheter fixing part is sleeved on the proximal end of the inner tube 110. The second splint fixing part is fixed on the side wall of the second catheter fixing part and faces the second synchronous conveyor belt. The second splint is fixed on the second splint fixing part, and the second synchronous conveyor belt is clamped between the second splint and the second splint fixing part, so that when the second synchronous conveyor belt moves, it can drive the inner tube 110 to move back and forth axially through the second fixing device.

[0067] Similarly, the structure of the first ratchet device 340 is the same as that of the second ratchet device 440. Refer to Figure 3 , and please refer to Figure 2 , the second ratchet device 440 includes a second ratchet, a second ratchet slider, a second ratchet slider rod and a second ratchet slider seat. The second ratchet 440 is arranged on the second driving wheel 421, and the second driving wheel 421 drives the second ratchet to rotate coaxially therewith. The surface of the second ratchet facing the second handwheel 430 has an annular sawtooth, and the central axis of the sawtooth overlaps with the central axis of the second ratchet. The sawtooth has teeth and grooves between adjacent teeth, and two second chamfered surfaces are provided on the connecting surface between the groove and two adjacent teeth, and the second chamfered surface is a flat chamfered surface. One end of the second ratchet slider is elastically fixed on the second ratchet slider seat, and the other end faces the second ratchet, and the other end of the second ratchet slider extends into a groove. The second ratchet slider seat is arranged on the outer wall of the housing 210.

[0068] The second ratchet slider seat includes a second main body part and a second fixing part, and the structure of the second main body part is the same as that of the first main body part 3441. Therefore, the second ratchet slider is arranged in the second main body part and is elastically connected to the second main body part, so that the second ratchet slider can elastically expand and contract along the axial direction of the second main body part. Further, there is a second elastic member between the end of the second ratchet slider close to the second handwheel 430 and the second main body part. The second elastic member is arranged at the bottom of the second main body part and drives the second ratchet slider to elastically expand and contract along the axial direction of the second main body part through deformation. The end of the second ratchet slider away from the second handwheel 430 has a second cut surface, so that the axial section of the second ratchet slider is a right trapezoid.

[0069] The second fixing portion is disposed at the opening, and a second notch is formed on the side wall of the second main body portion close to the opening. The second notch enables the second ratchet slider rod to be connected to the second ratchet slider located in the second main body portion. The second main body portion is fixed to the housing 210 through the second fixing portion. The second notch is in a strip shape along the circumferential direction of the side wall of the second main body portion, and the circumferential length is, for example, half of the circumferential length of the side wall of the second main body portion, so that the second ratchet slider rod can move from one end to the other end of the second notch and drive the second ratchet slider to rotate in the second main body portion.

[0070] The second ratchet slider rod is fixed to one end of the second ratchet slider close to the second handwheel 430 and is located in the second notch of the second main body portion. The second ratchet slider rod can drive the second ratchet slider to rotate in the second notch so as to change the direction of the second cutting surface.

[0071] This embodiment further provides an implant system, including the implant delivery handle 2, an outer tube 120, an inner tube 110, a tapered head 140, and a fixing head 150. The fixing head 150 is disposed at the distal end of the inner tube 110, the tapered head 140 is disposed at the distal end of the outer tube 120, the implant is compressively disposed in the distal end of the outer tube 120 and is located between the tapered head 140 and the fixing head 150. The implant delivery handle 2 drives the outer tube 120 and the inner tube 110 to perform axial movement to achieve loading, delivery, and release of the implant.

[0072] This embodiment further provides a working method of an implant delivery system, including:

[0073] Rotating the ratchet slider rod so that the angle between the cutting surface and the chamfered surface is 90°. At this time, the gear limits the ratchet slider in the groove where it is located, and performs safety self-locking on the inner tube or the outer tube through the synchronous transmission device;

[0074] Rotating the ratchet slider rod so that the angle between the cutting surface and the chamfered surface is 0°. At this time, the ratchet only rotates in the first direction or the second direction, and performs transmission guidance on the inner tube or the outer tube through the synchronous transmission device. The first direction and the second direction are opposite to each other;

[0075] Wherein, the transmission subsystem located at the proximal end is connected to the inner tube, and the transmission subsystem located at the distal end is connected to the outer tube.

[0076] Specifically, when the first ratchet device 340 works, as Figure 6aAs shown, move the first ratchet slider rod 343 along the first notch, so that the direction of the first cutting surface 3421 changes, and when the first cutting surface 3421 and the first chamfered surface 3411 face each other and are arranged in parallel, at this time, as Figure 6b shown, the first ratchet 341 can rotate along the first direction A (the direction in which the first chamfered surface 3411 rotates close to the first cutting surface 3421). As Figures 6c - 6d shown, when the first ratchet 341 rotates, the first chamfered surface 3411 gradually approaches the first cutting surface 3421, and under the action of the extrusion force of the first chamfered surface 3411 and the tooth 3413 where it is located, the first elastic member 345 is compressed, causing the first ratchet slider 342 to move towards the first handwheel 330. As Figure 6e shown, when the first ratchet slider 342 slides into the next groove, there is no extrusion force on the first ratchet slider 342, and the first elastic member 345 springs it back to its original position.

[0077] As Figure 6f shown, when the first ratchet 341 is ready to rotate in the second direction B, since no extrusion force towards the first handwheel 330 can be generated between the first chamfered surface 3412 and the first ratchet slider 342, the first ratchet slider 342 cannot move axially, thus restricting the first cutting surface 3421 in the groove 3414 between the first chamfered surfaces 3411 and 3412. Among them, the first direction A is opposite to the second direction B. As Figure 6f shown, when the first ratchet 341 rotates in the first direction A, the first handwheel 330 drives the first synchronous conveyor belt 323 and the outer tube 120 to move forward or backward along the axial direction of the housing 210 through the first driving wheel 321.

[0078] Move the first ratchet slider rod 343 along the first notch, so that the direction of the first cutting surface 3421 changes, and when the first cutting surface 3421 and the first chamfered surfaces 3411 and 3412 are not parallel, no matter whether the first ratchet 341 rotates in the first direction A or in the second direction B, since no extrusion force towards the first handwheel 330 can be generated between the first chamfered surfaces 3411 and 3412 and the first ratchet slider 342, the first ratchet slider 342 cannot move axially, thus restricting the first cutting surface 3421 in the groove 3414 between the first chamfered surfaces 3411 and 3412. At this time, the first ratchet device 340 is in a self-locking state.

[0079] When the second ratchet device is working, the second ratchet slider rod is moved along the second notch, so that the second section changes direction and the second section is arranged to face and be parallel to a second chamfered surface in the groove. At this time, the second ratchet can rotate along the first direction, and when the second ratchet rotates, the second chamfered surface facing the second section gradually approaches the second section, and under the extrusion force of the second chamfered surface and the teeth where it is located, the second elastic member is compressed and the second ratchet slider moves toward the second handwheel, and when the second ratchet slider slides into the next groove, the second ratchet slider has no extrusion force, and the second elastic member bounces it back to its original position.

[0080] When the second ratchet is ready to rotate in the second direction, since a squeezing force toward the second hand wheel cannot be generated between the second chamfered surface in the groove that is arranged opposite to the second section and the second ratchet slider, the second ratchet slider cannot move along its axial direction, thereby restricting the second section in the groove, wherein the first direction is opposite to the second direction. When the second ratchet rotates in the first direction, the second hand wheel drives the second synchronous transmission belt and the inner tube to move forward or backward along the axial direction of the outer shell through the second driving wheel.

[0081] The second ratchet slider rod is moved along the second notch so that the second section changes direction and is non-parallel to the two second chamfered surfaces of the groove in which the second section is located. Regardless of whether the second ratchet rotates along the first direction A or the second direction B, since no squeezing force toward the second hand wheel 430 can be generated between the two second chamfered surfaces and the second ratchet slider, the second ratchet slider cannot move along its axial direction, thereby restricting the second section in the groove in which it is located. At this time, the second ratchet device 440 is in a self-locking state.

[0082] Method of using an implant delivery handle: First, move the first ratchet slider rod 343 along the first notch so that the first cutting surface 3421 faces the proximal end and is arranged opposite and parallel to the first chamfered surface 3411. At this time, the first ratchet 341 can only rotate clockwise. At the same time, move the second ratchet slider rod along the second notch so that the second cutting surface faces the proximal end and is arranged opposite and parallel to a second chamfered surface of the slot where the end of the second ratchet slider away from the second handwheel is located. At this time, the second ratchet can only rotate clockwise. Then, rotate the first handwheel 330 and the second handwheel 430 clockwise respectively, so that the first transmission subsystem 300 drives the outer tube 120 to move towards the proximal end, and at the same time the second transmission subsystem 400 drives the inner tube 110 to move towards the proximal end. Then, after the inner tube 110 and the outer tube 120 have moved a certain distance towards the proximal end respectively, move the first ratchet slider rod 343 along the first notch so that the first cutting surface 3421 is not parallel to both the first chamfered surfaces 3411 and 3412. For example, when the included angle is 90°, the first ratchet slider 342 is limited in the slot 3414, and the first ratchet 341 cannot rotate clockwise or counterclockwise. At the same time, the second ratchet slider rod is limited in its corresponding slot, and the second ratchet cannot rotate clockwise or counterclockwise. That is, both the first ratchet device 340 and the second ratchet device 440 are in a self-locking state. Remove the conical head, place the implant 3 inside the tube at the distal end of the outer tube 120, and fix the implant 3 between the conical head 140 and the fixed head. Then, move the first ratchet slider rod 343 along the first notch so that the first ratchet 341 can only rotate counterclockwise, and at the same time move the second ratchet slider rod along the second notch so that the second ratchet can only rotate counterclockwise. Then, rotate the first handwheel 330 and the second handwheel 430 counterclockwise respectively, so that the first transmission subsystem 300 drives the outer tube 120 to move towards the distal end, and the second transmission subsystem 400 drives the inner tube to move towards the distal end. Then, when moving to a preset position, lock the first ratchet device 340 and the second ratchet device 440, and after the implant 3 is released, move the first ratchet slider rod 343 along the first notch so that the first ratchet 341 can only rotate clockwise, and at the same time move the second ratchet slider rod along the second notch so that the second ratchet can only rotate clockwise to move the inner tube 110 and the outer tube 120 towards the proximal end. During the above process, there may also be a situation where the inner tube 110 moves towards the distal end and the outer tube 120 moves towards the proximal end; or, the inner tube 110 and the outer tube 120 move towards the distal end or the proximal end simultaneously to release the valve stent.

[0083] In summary, the present invention provides an implant delivery handle, an implant system, a delivery system and a working method thereof. The implant delivery handle includes two transmission subsystems arranged along the axial direction of the catheter assembly. The transmission subsystem at the distal end is connected to the proximal end of the outer tube of the catheter assembly, and the transmission subsystem at the proximal end is connected to the proximal end of the inner tube of the catheter assembly. Wherein, the transmission subsystem includes a synchronous transmission device and a ratchet device. The ratchet device is fixed on the synchronous transmission device and is used to perform safety self-locking and transmission guidance on the outer tube or the inner tube through the synchronous transmission device, so as to realize the locking of the inner tube and the outer tube in a single direction, achieve the safety self-locking of the implant delivery handle, and avoid the uncontrolled position out-of-control of the inner tube or the outer tube.

[0084] In addition, the present invention also provides an implant system, a delivery system and a working method thereof, which can realize the precise operation of the implant delivery system and the delivery system, avoid the reverse movement of the inner tube or the outer tube caused by the operator's operation error, and thus avoid the uncontrolled position out-of-control of the inner tube or the outer tube.

[0085] In addition, it should be noted that unless otherwise specified or indicated, the terms "first" and "second" in the specification are only used to distinguish each component, element, step, etc. in the specification, rather than to represent the logical relationship or sequential relationship, etc. between each component, element, step.

[0086] It can be understood that although the present invention has been disclosed above with preferred embodiments, the above embodiments are not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, many possible changes and modifications can be made to the technical solution of the present invention by using the disclosed technical content, or modified into equivalent embodiments with equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the scope of the protection of the technical solution of the present invention.

Claims

1. An implant delivery handle, characterized in that, It includes two transfer subsystems arranged axially along the catheter assembly. The transfer subsystem located at the distal end connects to the proximal end of the outer tube of the catheter assembly, and the transfer subsystem located at the proximal end connects to the proximal end of the inner tube of the catheter assembly; Among them, the transfer subsystem includes a synchronous transfer device, a ratchet device, a fixing device and a handwheel. The ratchet device is fixed on the synchronous transfer device and is used to perform safety self-locking and transmission guiding on the outer tube or the inner tube through the synchronous transfer device. The fixing device connects the synchronous transfer device and also connects the outer tube or the inner tube; the handwheel connects the synchronous transfer device and is used to drive the outer tube or the inner tube to perform axial movement through the synchronous transfer device and the fixing device; The ratchet device includes a ratchet, a ratchet slider, a ratchet slider rod and a ratchet slider seat, The ratchet slider seat is used to load the ratchet slider; One end of the ratchet slider is elastically fixed on the ratchet slider seat, and the other end of the ratchet slider is close to the ratchet and is used to control whether the ratchet rotates and the rotation direction when it rotates; The ratchet is fixed on the synchronous transfer device and is used to cooperate with the ratchet slider to control whether the outer tube or the inner tube performs axial movement and the direction of the axial movement; and The ratchet slider rod connects to one end of the ratchet slider and is used to drive the ratchet slider to rotate.

2. The implant delivery handle according to claim 1, characterized in that, The synchronous transfer device includes a driving wheel, a driven wheel and a synchronous conveyor belt. The synchronous conveyor belt is arranged on the driving wheel and the driven wheel. The driving wheel is coaxially arranged with the handwheel and rotates with the handwheel, and is used to drive the driven wheel to rotate in the same direction as the driving wheel and drive the synchronous conveyor belt to move axially along the outer tube.

3. The implant delivery handle according to claim 2, characterized in that, The ratchet and the handwheel are coaxially arranged, and the ratchet is located between the driving wheel and the handwheel. The surface of the ratchet facing the handwheel has gears, and the other end of the ratchet slider is located in the groove of the gear.

4. The implant delivery handle according to claim 3, characterized in that, The other end of the ratchet slider has a cutting surface, and there is a chamfered surface between the groove of the gear and the teeth on both sides thereof. The ratchet slider is used to control whether the ratchet rotates and the rotation direction when it rotates by changing the angle between the cutting surface and the chamfered surface.

5. The implant delivery handle according to claim 4, characterized in that, The chamfered surface and the cutting surface are arranged in parallel so that the ratchet can rotate in a single direction; or, The chamfered surface and the cutting surface are arranged non-parallel so that the ratchet does not rotate.

6. The implant delivery handle according to claim 2, characterized in that, The fixing device includes a catheter fixing part, a splint fixing part and a splint. The catheter fixing part is sleeved on the proximal end of the outer tube or the proximal end of the inner tube. The splint fixing part is fixed on the catheter fixing part and faces the synchronous conveyor belt. The splint is fixed on the splint fixing part and clamps the synchronous conveyor belt between the splint and the splint fixing part.

7. An implant delivery system, characterized in that, It includes an implant delivery handle according to any one of claims 1 to 6, and includes a catheter assembly. The catheter assembly includes an outer tube and an inner tube sleeved from the outside to the inside in sequence. The implant delivery handle drives the outer tube and the inner tube to perform axial movement.

8. An implant system, characterized in that, Comprising an implant delivery handle, an outer tube, an inner tube, a tapered head, and a fixing head as described in any one of claims 1 to 6, the fixing head being provided at the distal end of the inner tube, the tapered head being provided at the distal end of the outer tube, the implant being compressively disposed within the distal end of the outer tube and being located between the tapered head and the fixing head, the implant delivery handle driving the outer tube and the inner tube to perform axial movement to achieve loading, delivery, and release of the implant.

9. A working method of an implant delivery system, including the implant delivery system according to claim 7, characterized in that, The working method comprises: Rotating the ratchet slider rod such that the cutting surface of the ratchet slider and the chamfered surface of the gear are non-parallel, at this time, the gear limits the ratchet slider within the groove where the ratchet slider is located, and performs safety self-locking on the inner tube or the outer tube through the synchronous transmission device; Rotating the ratchet slider rod such that the cutting surface and the chamfered surface are parallel, at this time, the ratchet rotates only in the first direction or the second direction, and performs transmission guidance on the inner tube or the outer tube through the synchronous transmission device, the first direction and the second direction being opposite; Wherein, the transmission subsystem located at the proximal end is connected to the inner tube, and the transmission subsystem located at the distal end is connected to the outer tube.

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