Transporter for trans-femoral mitral valve clip

Abstract

The present invention belongs to the technical field of medical devices, and particularly relates to a delivery device for a trans-femoral mitral valve clip applier. A delivery device for a trans-femoral mitral valve clip applier includes: an adjustable bending structure having an adjustable bending tube with an adjustable degree of bending and a bending adjustment handle; a delivery structure having a delivery tube passing through the adjustable bending tube and a delivery handle, which is detachably connected to the trans-femoral mitral valve clip applier and is used to deliver the trans-femoral mitral valve clip applier to a target position; the delivery device for a trans-femoral mitral valve clip applier further includes: a connection structure that can perform rotational and translational movements, with its distal end connected to the bending adjustment handle and its proximal end connected to the delivery handle, driving the delivery structure to perform rotational and translational movements. The present invention designs a connection structure between the delivery structure and the adjustable bending structure, connecting the two parts into one body through the connection structure, and does not require separate control during the surgical process, improving the convenience of operation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a delivery device for a trans-femoral mitral valve clip applier. Background Art

[0002] In the cardiovascular system, natural heart valves (such as the aortic valve, pulmonary valve, mitral valve, and tricuspid valve) play a crucial role in ensuring the forward flow of sufficient blood supply. However, these heart valves may be damaged due to congenital malformations, inflammatory processes, infectious conditions, or diseases, thereby reducing their efficiency; the vast majority of patients undergoing valve surgery such as mitral valve surgery suffer from degenerative diseases, which cause the leaflets of the natural valve (e.g., the mitral valve) to malfunction, resulting in prolapse and regurgitation.

[0003] Taking the mitral valve as an example, mitral regurgitation may be caused by a variety of different mechanical defects in the mitral valve or the left ventricular wall. The leaflets, chordae tendineae connecting the leaflets to the papillary muscles, or the papillary muscles themselves or the left ventricular wall may be damaged or otherwise malfunction. Usually, the annulus may be damaged, dilated, or weakened, thus limiting the ability of the mitral valve to fully close against the greater pressure of the left ventricle, and such damage can lead to severe cardiovascular damage or death.

[0004] The trans-femoral repair method has received increasing attention due to its high safety. Currently, the clip applier mainly enters the left atrium from the right femoral vein, through the right atrium, and puncturing the atrial septum, and then crosses the mitral valve into the right ventricle to clip the leaflets.

[0005] The application number is 2021113240164, and the invention name is: Delivery device for trans-femoral valve repair, which discloses a delivery device for delivering a mitral valve clip applier. This delivery device can precisely control the opening and closing degree of the clip applier to complete the delivery of the clip applier. However, the adjustable bending structure and the delivery structure of this delivery device are only connected by a delivery tube, and there is no other interaction force between them. However, during the delivery process of the clip applier, especially when pushing the position of the delivery tube distally, it is necessary to rotate the delivery structure simultaneously to reduce the viscous force between the delivery tube and the bending structure. This increases the workload of medical staff during the use process, increases the operation time, and correspondingly increases the pain of the patient. Summary of the Invention

[0006] Aiming at the technical problem that in the existing delivery device, the adjustable bending structure and the delivery structure are only connected by a delivery tube, and when pushing the position of the delivery tube distally, it is necessary to rotate the delivery structure simultaneously, which increases the workload, operation time, and patient pain, the present invention aims to provide a delivery device for a trans-femoral mitral valve clip applier.

[0007] A delivery device for a trans-femoral mitral valve clip applier includes:

[0008] An adjustable bending structure, comprising an adjustable bending pipe with adjustable bending degree and a bending adjustment handle;

[0009] A conveying structure, comprising a conveying pipe passing through the adjustable bending pipe and a conveying handle, which is detachably connected to the transcatheter mitral valve clip applier, and is used for conveying the transcatheter mitral valve clip applier to a target position;

[0010] The transcatheter mitral valve clip applier delivery device further comprises:

[0011] A connecting structure, capable of performing rotational and translational movements, with its distal end connected to the bending adjustment handle and its proximal end connected to the conveying handle, driving the conveying structure to perform rotational and translational movements.

[0012] As a preferred solution, the connecting structure comprises:

[0013] A rotating nut, with an internal thread and a circle of nut grooves on the inner wall of its distal end, and the nut grooves are located on the distal side of the internal thread;

[0014] A guiding cylinder, with its distal end connected to the bending adjustment handle and a first snap ring provided at its proximal end, and the first snap ring is snap-fitted into the nut grooves;

[0015] An external thread cylinder, with an external thread on its outer wall, and the external thread cylinder is threadedly connected to the rotating nut, and its proximal end is connected to the conveying handle.

[0016] As a preferred solution, when the rotating nut rotates by 5° - 20°, the external thread cylinder axially moves by 5 cm - 10 cm.

[0017] As a preferred solution, at least one guiding rod is axially provided on the inner wall of the guiding cylinder;

[0018] At least one guiding groove is axially provided on the outer wall of the external thread cylinder, the distal end of the external thread cylinder is inserted into the guiding cylinder, and the guiding groove is slidably connected to the guiding rod.

[0019] As a preferred solution, a limiting plate is provided at the distal end of the external thread cylinder, and the outer diameter of the limiting plate is larger than the inner diameter of the distal end of the rotating nut.

[0020] As a preferred solution, the connecting structure further comprises:

[0021] A raised ring, with its proximal end integrally connected to the conveying handle and a circle of outwardly protruding grooves on its inner wall;

[0022] A second snap ring is provided at the proximal end of the external thread cylinder, the proximal end of the external thread cylinder extends into the interior of the raised ring, and the second snap ring is snap-fitted and connected to the outwardly protruding grooves.

[0023] As a preferred solution, an axially arranged insert guide groove communicating inside and outside is provided on the rotary nut;

[0024] The connection structure further includes:

[0025] A clamping ring, integrally connected with the conveying handle, with its distal end inserted into the proximal interior of the rotary nut, and a circle of clamping teeth is arranged on the outer wall, and the length direction of the clamping teeth is axial;

[0026] An insert, one end is a pushing end and the other end is an insert tip. The pushing end is located outside the rotary nut, and the insert tip passes through the insert guide groove and extends into the interior of the rotary nut. When the pushing end slides proximally along the insert guide groove, the insert tip can be meshed and connected with the clamping teeth, and when the pushing end slides distally along the insert guide groove, the insert tip can be disengaged from the clamping teeth.

[0027] As a preferred solution, the clamping ring, the convex ring and the conveying handle are integrally connected from the distal end to the proximal end;

[0028] The proximal end of the external thread cylinder passes through the clamping ring and the convex ring in sequence and is clamped and connected with the external convex groove.

[0029] As a preferred solution, the insert further includes an insert guiding section. The pushing end is arranged at one end of the insert guiding section, and the other end of the insert guiding section is the insert tip;

[0030] An anti - detachment plate is arranged on the insert guiding section. The anti - detachment plate is located between the pushing end and the insert tip. The length of the anti - detachment plate is greater than the width of the insert guide groove, the distance between the anti - detachment plate and the pushing end is greater than the depth of the insert guide groove, and the anti - detachment plate is placed inside the rotary nut.

[0031] As a preferred solution, a stepped hole is arranged inside the distal end of the guiding cylinder;

[0032] A stepped snap ring corresponding to the stepped hole is arranged at the proximal end of the bending adjustment handle, and the stepped snap ring is clamped with the stepped hole to realize the clamping connection between the bending adjustment handle and the guiding cylinder.

[0033] As a preferred solution, the conveying handle includes:

[0034] A conveying housing, with its distal end connected to the proximal end of the conveying pipe and the proximal end of the connection structure respectively;

[0035] A wire control assembly, which can slide axially on the conveying housing, is connected to the clip of the trans - femoral mitral valve clip, and controls the opening and closing of the clip when the wire control assembly slides axially;

[0036] The number of the wire control components is the same as that of the clamping pieces.

[0037] As a preferred solution, the wire control component includes:

[0038] A wire control end that can slide axially along the conveying pipe on the conveying housing;

[0039] A conveying wire that extends axially along the conveying pipe and is detachably connected to the clamping piece of the trans-femoral mitral valve clip applier;

[0040] A wire locking end that is arranged on the wire control end and locks both ends of the conveying wire on the wire control end.

[0041] As a preferred solution, the wire control component further includes:

[0042] An axial engaging member that is detachably and engagingly connected to the wire control end;

[0043] When the axial engaging member is engagingly connected to the wire control end, the length of the conveying wire is locked. When it is necessary to pull or convey the conveying wire, the wire control end is separated from the axial engaging member, and the wire control end is slid axially to realize pulling or conveying the conveying wire.

[0044] As a preferred solution, a guiding member is arranged in the conveying housing. The guiding member is slidably connected to the wire control end, and the guiding member guides the wire control end to slide axially along the conveying pipe.

[0045] As a preferred solution, the trans-femoral mitral valve clip applier delivery device further includes:

[0046] A release structure that is detachably connected to the trans-femoral mitral valve clip applier and can control the connection or separation between the trans-femoral mitral valve clip applier delivery device and the trans-femoral mitral valve clip applier;

[0047] The release structure includes:

[0048] A core rod, the distal end of which passes through the conveying pipe and is detachably connected to the trans-femoral mitral valve clip applier, and a release control end is arranged at the proximal end. The core rod is connected or separated from the trans-femoral mitral valve clip applier through the release control end.

[0049] As a preferred solution, the connection mode between the core rod and the trans-femoral mitral valve clip applier is one of screw connection or engaging connection.

[0050] As a preferred solution, the release structure further includes:

[0051] A clip applier control component for controlling the working state of the trans-femoral mitral valve clip applier;

[0052] The clip applicator control assembly includes:

[0053] A rotating sleeve, with open proximal and distal ends and a hollow interior, is connected to the delivery handle;

[0054] A spiral tube, with open proximal and distal ends and a hollow interior, is at least partially located inside the rotating sleeve, the proximal end extends out of the rotating sleeve, and an external thread is provided on the outer wall;

[0055] A core rod fixing member is detachably connected to the core rod and detachably connected to the proximal end of the spiral tube;

[0056] A propulsion nut is threadedly connected to the external thread of the spiral tube at one end, and the other end can move circumferentially along the rotating sleeve;

[0057] The distal end of the core rod sequentially passes through the core rod fixing member, the spiral tube and the delivery tube and then is connected to the transcatheter mitral clip applicator;

[0058] When the propulsion nut is rotated, the spiral tube axially extends out of or retracts into the rotating sleeve, driving the core rod fixing member, and further driving the core rod to be pushed distally or pulled back to control the working state of the transcatheter mitral clip applicator.

[0059] As a preferred solution, a pin slot is circumferentially provided on the outer wall of the rotating sleeve;

[0060] The proximal inner wall of the propulsion nut is provided with an internal thread and is threadedly connected to the external thread of the spiral tube through the internal thread. A pin mounting hole is radially dug at the distal end of the propulsion nut. The propulsion nut is connected to the rotating sleeve through a propulsion pin sequentially passing through the pin mounting hole and the pin slot to realize that the propulsion nut can move circumferentially along the rotating sleeve.

[0061] As a preferred solution, a sleeve flange is provided on the proximal outer wall of the rotating sleeve;

[0062] The proximal inner wall of the propulsion nut is provided with an internal thread and is threadedly connected to the external thread of the spiral tube through the internal thread. A nut necking is provided at the distal end of the propulsion nut. The propulsion nut is sleeved outside the sleeve flange through the nut necking and connected to the rotating sleeve to realize that the propulsion nut can move circumferentially along the rotating sleeve.

[0063] As a preferred solution, the transcatheter mitral clip applicator delivery device further includes:

[0064] A loader structure for loading the transcatheter mitral clip applicator and allowing the adjustable bend tube to pass through;

[0065] The loader structure includes:

[0066] A loading cavity, which is open at both the proximal and distal ends, hollow inside, and can accommodate the transcatheter mitral valve clip and the adjustable bent tube;

[0067] A loading head, which communicates with the proximal end of the loading cavity and has a loading connection part at the proximal end;

[0068] A sealing end structure, which is detachably connected to the loading connection part, allows the adjustable bent tube to pass through and is sealingly connected to the adjustable bent tube.

[0069] As a preferred solution, the sealing end structure includes:

[0070] A head nut, the proximal end face of which has a nut through-hole communicating inside and outside, is detachably connected to the loading connection part and encloses a sealing gasket accommodating cavity with one end having the nut through-hole, and the nut through-hole can be passed through by the adjustable bent tube;

[0071] A sealing gasket, which is arranged in the sealing gasket accommodating cavity, can be passed through by the adjustable bent tube and is sealingly connected to the adjustable bent tube.

[0072] As a preferred solution, the sealing gasket is an elastic variable-diameter tube body with a contracted middle and expanded ends. The sealing gasket sequentially includes a first expansion part, a contraction part, and a second expansion part from the proximal end to the distal end. The proximal end of the first expansion part abuts against the proximal end face of the head nut, and the outer wall of the second expansion part fits against the inner wall of the loading connection part.

[0073] As a preferred solution, a groove ring is also sleeved outside the first expansion part, and the outer wall of the groove ring fits against the circumferential inner wall of the proximal end of the head nut;

[0074] The groove ring adopts a sealing ring body, the proximal end of which is connected to the circumferential outer wall of the first expansion part, resulting in a buffer groove being formed between the distal end of the sealing ring body and the circumference of the first expansion part.

[0075] As a preferred solution, the transcatheter mitral valve clip delivery device further includes:

[0076] An outer sheath tube structure, which provides a channel for the adjustable bending structure and the delivery structure;

[0077] The outer sheath tube structure includes:

[0078] An outer sheath tube, which serves as the access channel for the adjustable bent tube;

[0079] A sheath tube handle, which communicates with the outer sheath tube and controls the bending degree of the outer sheath tube.

[0080] The positive and progressive effects of the present invention are as follows: The present invention uses a delivery device for a trans-femoral mitral valve clip applier, which has the following advantages:

[0081] 1. A connection structure is designed between the delivery structure and the adjustable bending structure, and the two parts are connected as a whole through the connection structure, so that multiple people or a single person with multiple hands are not required during the operation, improving the convenience of operation.

[0082] 2. By moving the position of the insertion piece, the synchronous or asynchronous movement of the adjustable bending structure and the delivery structure can be controlled, meeting more operability requirements.

[0083] 3. A stepped hole is provided at the connection between the guiding cylinder and the adjustable bending structure, making the clamping more stable.

[0084] 4. The clip of the trans-femoral mitral valve clip applier is controlled by a wire control assembly. Each wire control assembly controls a single clip independently without interference. When the clip fails to capture the leaflet properly, the trans-femoral mitral valve clip applier can be re-controlled to lift the clip, release the leaflet, and re-capture the leaflet.

[0085] 5. All parts are organically combined, and one person can complete the operation, which is simple and convenient. BRIEF DESCRIPTION OF THE DRAWINGS

[0086] Figure 1 is a schematic diagram of the overall structure of the present invention;

[0087] Figure 2 is Figure 1 a partial structure schematic diagram of;

[0088] Figure 3 is Figure 2 a cross-sectional view of;

[0089] Figure 4 is Figure 3 a partially enlarged view of;

[0090] Figure 5(a) is a schematic diagram of a structure of the rotating nut of the present invention;

[0091] Figure 5(b) is another perspective view of Figure 5(a);

[0092] Figure 5(c) is a partial cross-sectional view of Figure 5(a);

[0093] Figure 5(d) is a schematic diagram of a structure of the insertion piece in Figure 5(a);

[0094] Figure 6(a) is a schematic diagram of a structure of the guiding cylinder of the present invention;

[0095] Figure 6(b) is another perspective view of Figure 6(a);

[0096] Figure 6(c) is a schematic structural diagram of a bending adjustment handle cooperating with Figure 6(a);

[0097] Figure 7 This is a schematic structural diagram of the external thread cylinder of the present invention;

[0098] Figure 8(a) is a partial connection schematic diagram of the connection structure, conveying structure and release structure of the present invention;

[0099] Figure 8(b) is a partial internal cross-sectional view of the connection structure, conveying structure and release structure of the present invention;

[0100] Figure 9(a) is a schematic structural diagram of a clamping device control component of the present invention;

[0101] Figure 9(b) is an internal cross-sectional view of Figure 9(a);

[0102] Figure 10(a) is another schematic structural diagram of a clamping device control component of the present invention;

[0103] Figure 10(b) is an internal cross-sectional view of Figure 10(a);

[0104] Figure 11(a) is a schematic structural diagram of a loader structure of the present invention;

[0105] Figure 11(b) is an exploded view of Figure 11(a);

[0106] Figure 12(a) is a schematic structural diagram of a sealing gasket in Figure 11(b);

[0107] Figure 12(b) is a schematic diagram of the other side of Figure 12(a). Detailed implementation manners

[0108] In order to make the technical means, creative features, achieved purposes and functions of the present invention easy to understand, the present invention will be further described below with reference to specific illustrations.

[0109] In the present invention, when describing a delivery device for a transcatheter mitral valve clip, "proximal" refers to the side in the direction of the end manipulated by the user. Correspondingly, "distal" refers to the side in the direction away from the end manipulated by the user.

[0110] In the present invention, when describing a delivery device for a transcatheter mitral valve clip, "axial direction" refers to the direction between "proximal" and "distal".

[0111] Refer to Figures 1 to 3 , a delivery device for a transcatheter mitral valve clip may sequentially include a release structure 100, a delivery structure 200, an adjustable bending structure 300, a loader structure 400 and an outer sheath tube structure 500 from the proximal end to the distal end.

[0112] The adjustable bending structure 300 has an adjustable bending pipe 310 with an adjustable bending degree and a bending adjustment handle 320. The adjustable bending pipe 310 can be bent, and the conveying pipe 210 can pass through the adjustable bending pipe 310. When the adjustable bending pipe 310 is bent, the conveying pipe 210 inside it and the central core rod inside the conveying pipe 210 are bent together. The bending adjustment handle 320 is communicated with the adjustable bending pipe 310, and the bending adjustment handle 320 controls the bending degree of the adjustable bending pipe 310.

[0113] The conveying structure 200 is detachably connected to the transcatheter mitral valve clip applier, and the conveying structure 200 is used to convey the transcatheter mitral valve clip applier to the target position. The conveying structure 200 includes a conveying pipe 210 and a conveying handle 220. The conveying pipe 210 can pass through the adjustable bending pipe 310 and extend out of the adjustable bending pipe.

[0114] The transcatheter mitral valve clip applier conveyor of the present invention further includes a connection structure 600. The connection structure 600 is located between the conveying structure 200 and the adjustable bending structure 300. The connection structure 600 can perform rotational and translational movements. The distal end of the connection structure 600 is connected to the bending adjustment handle 320, and the proximal end of the connection structure 600 is connected to the conveying handle 220. The connection structure 600 drives the conveying structure 200 to perform rotational and translational movements.

[0115] In the present invention, a connection structure 600 is designed between the conveying structure 200 and the adjustable bending structure 300. The conveying structure 200 and the adjustable bending structure 300 are connected as a whole through the connection structure 600, and multiple people or a single person with multiple hands are not required during the operation, greatly improving the convenience of the operation.

[0116] In some embodiments, referring to Figures 1 to 7 , the connection structure 600 includes a rotating nut 610, a guiding cylinder 620, and an external thread cylinder 630.

[0117] Referring to FIGS. 5(a) to 5(c), the inner wall of the distal end of the rotating nut 610 has an internal thread 611, and a threaded end is formed on the distal side of the rotating nut 610. The inner wall of the distal end of the rotating nut 610 also has a nut groove 612, and the nut groove 612 is located on the distal side of the internal thread 611.

[0118] Referring to Figure 2 and Figure 3 FIGS. 6(a) and 6(b), the distal end of the guiding cylinder 620 is connected to the bending adjustment handle 320, and a first snap ring 621 is provided at the proximal end of the guiding cylinder 620. The first snap ring 621 is snap-fitted into the nut groove 612.

[0119] Referring to Figures 2 to 4 、 Figure 7, the outer wall of the external thread cylinder 630 has an external thread 631. The threaded connection between the external thread cylinder 630 and the rotating nut 610 is achieved through the threaded connection of the external thread 631 and the internal thread 611. The proximal end of the external thread cylinder 630 is connected to the conveying handle 220.

[0120] When it is necessary to control the axial movement of the conveying structure 200, rotate the rotating nut 610. The internal thread 611 inside the rotating nut 610 drives the external thread cylinder 630 to move axially. Since the proximal end of the guiding cylinder 620 is clamped in the nut groove 612 through the first snap ring 621, during the rotation of the rotating nut 610, the guiding cylinder 620 and the adjustable bending structure 300 connected thereto do not rotate. And the conveying structure 200 is connected to the external thread cylinder 630. Therefore, during the rotation of the rotating nut 610, the conveying structure 200 follows the external thread cylinder 630 to move axially.

[0121] In some embodiments, by adjusting the thread pitch of the external thread cylinder 630, the distance of the axial movement of the conveying structure 200 can be controlled to match the rotation angle of the rotating nut 610. Preferably, when the rotating nut 610 rotates 5° - 20°, the external thread cylinder 630 moves axially 5 cm - 10 cm.

[0122] In some embodiments, referring to FIG. 6(b), at least one guiding rod 622 is axially arranged on the inner wall of the guiding cylinder 620. Refer to Figure 7 , at least one guiding groove 632 is axially arranged on the outer wall of the external thread cylinder 630. The distal end of the external thread cylinder 630 is inserted into the guiding cylinder 620, and the guiding groove 632 is slidably connected to the guiding rod 622.

[0123] When the rotating nut 610 rotates to drive the external thread cylinder 630 to move axially, the guiding groove 632 moves more stably axially under the guidance of the guiding rod 622.

[0124] Preferably, two guiding rods 622 are axially arranged on the inner wall of the guiding cylinder 620, and the two guiding rods 622 are axially symmetrically arranged on the opposite sides of the inner wall of the guiding cylinder 620. Two guiding grooves 632 are axially arranged on the outer wall of the external thread cylinder 630, and the positions of the guiding grooves 632 correspond to the corresponding guiding rods 622 to achieve that one guiding groove 632 is slidably connected to one guiding rod 622.

[0125] When an external thread 631 is arranged on the outer wall of the rotating nut 610, as shown in Figure 7 , when the guiding groove 632 is axially arranged, it directly passes through the external thread 631. Since the guiding groove is usually of a small width and only needs to accommodate the guiding rod 622, it does not affect the threaded connection between the external thread 631 and the internal thread 611.

[0126] In some embodiments, referring to Figure 7 , a limiting plate 633 is provided at the distal end of the external thread cylinder 630, and the outer diameter of the limiting plate 633 is greater than the inner diameter of the distal end of the rotating nut 610.

[0127] During the rotation of the rotating nut 610, the external thread cylinder 630 is driven to move axially, which can be towards the distal end or towards the proximal end. When moving towards the proximal end, in order to prevent the external thread cylinder 630 from falling out of the rotating nut 610 and affecting the use, a limiting plate 633 is provided at the distal end of the external thread cylinder 630. When the external thread cylinder 630 moves towards the proximal end, since the outer diameter of the limiting plate 633 is greater than the inner diameter of the distal end of the rotating nut 610, the limiting plate 633 is stuck on the outer side of the distal end of the rotating nut 610, and the external thread cylinder 630 cannot continue to move towards the proximal end, effectively avoiding the possibility of the external thread cylinder 630 falling out of the rotating nut 610.

[0128] In some embodiments, referring to Figures 1 to 3 , FIGS. 8(a) and 8(b), the connecting structure 600 further includes a protruding ring 640. The proximal end of the protruding ring 640 is integrally connected to the conveying handle 220, and the inner wall of the protruding ring 640 has a circumferential outer protruding groove 641. Referring to Figure 7 , a second snap ring 634 is provided at the proximal end of the external thread cylinder 630. The proximal end of the external thread cylinder 630 extends into the interior of the protruding ring 640, and the second snap ring 634 is snap-connected to the outer protruding groove 641.

[0129] After the connection between the connecting structure 600 and the conveying handle 220 of the present invention adopts the above design, when the external thread cylinder 630 moves axially, since the second snap ring 634 is snap-connected to the outer protruding groove 641, the conveying handle 220 can be driven to move axially.

[0130] In some embodiments, referring to Figures 1 to 3 , FIGS. 5(a) and 5(b), an axially arranged inner and outer communicating insert guide groove 613 is provided on the rotating nut 610.

[0131] Referring to Figures 1 to 3 , FIGS. 8(a) and 8(b), the connecting structure 600 further includes a snap ring 650 and an insert 660.

[0132] Referring to FIGS. 8(a) and 8(b), the snap ring 650 is integrally connected to the conveying handle 220. The distal end of the snap ring 650 is inserted into the interior of the proximal end of the rotating nut 610, and a circumferential snap tooth 651 is provided on the outer wall of the snap ring 650. The length direction of the snap tooth 651 is axial. That is, a plurality of snap teeth 651 with the length direction being axial are arranged in a circle around the circumference of the snap ring 650.

[0133] Referring to Figures 5(a) to 5(d), one end of the insert piece 660 is the pushing end 661, and the other end of the insert piece 660 is the tip 662 of the insert piece. The pushing end 661 is located outside the rotating nut 610. The tip 662 of the insert piece passes through the insert guide groove 613 and extends into the rotating nut 610. When the pushing end 661 slides proximally along the insert guide groove 613, the tip 662 of the insert piece can be engaged and connected with the engaging teeth 651. When the pushing end 661 slides distally along the insert guide groove 613, the tip 662 of the insert piece can be disengaged from the engaging teeth 651.

[0134] By moving the position of the insert piece 660, the present invention can control the synchronous movement or asynchronous movement of the adjustable bending structure 300 and the conveying structure 200. When the insert piece 660 moves to the threaded end side of the rotating nut 610, the insert piece 660 is away from the engaging teeth 651, and the adjustable bending structure 300 and the conveying structure 200 are separated and move independently. When the adjustable bending structure 300 and the conveying structure 200 need to be linked, when the insert piece 660 moves along the insert guide groove 613 to the proximal side of the rotating nut 610, the insert piece 660 is inserted into the engaging teeth 651, and the adjustable bending structure 300 and the conveying structure 200 move synchronously. When the rotating nut 610 rotates, while driving the conveying structure 200 to move forward and backward, it also rotates.

[0135] In some embodiments, referring to FIG. 5(c), the inner diameter of the rotating nut 610 at the insert guide groove 613 is greater than the inner diameter of the rotating nut 610 at the internal thread 611. That is, the inner diameter of the proximal side of the rotating nut 610 is greater than the inner diameter of the distal side, so as to reserve more movement space for the insert piece 660 to perform translation.

[0136] In some embodiments, referring to FIG. 8(b), the engaging ring 650, the protruding ring 640 and the conveying handle 220 are integrally connected from the distal end to the proximal end. The proximal end of the external thread cylinder 630 sequentially passes through the engaging ring 650 and the protruding ring 640 and is then snap-connected with the external convex groove 641.

[0137] The engaging ring 650 and the protruding ring 640 of the present invention can be integrally connected to the conveying handle independently, and preferably are integrally connected to the conveying handle through mutual connection as shown in FIG. 8(b) to achieve the compactness of the structure.

[0138] In some embodiments, referring to FIG. 5(d), the insert piece 660 further includes an insert piece guiding section 663. The pushing end 661 is disposed at one end of the insert piece guiding section 663, and the other end of the insert piece guiding section 663 is an insert piece tip 662. An anti - detachment plate 664 is provided on the insert piece guiding section 663. The anti - detachment plate 664 is located between the pushing end 661 and the insert piece tip 662. The length of the anti - detachment plate 664 is greater than the width of the insert piece guiding groove 613, and the distance between the anti - detachment plate 664 and the pushing end 661 is greater than the depth of the insert piece guiding groove 613. The anti - detachment plate 664 is built into the rotating nut 610. The anti - detachment plate 664 can cooperate with the rotating nut 610 to prevent the insert piece 660 from falling off the insert piece guiding groove 613 of the rotating nut 610 during use.

[0139] In some embodiments, referring to FIG. 6(a), a stepped hole 623 is provided inside the distal end of the guiding cylinder 620. Referring to FIG. 6(c), a stepped snap ring 321 corresponding to the stepped hole 623 is provided at the proximal end of the bending adjustment handle 320. The stepped snap ring 321 is snap - connected to the stepped hole 623 to realize the snap - connection between the bending adjustment handle 320 and the guiding cylinder 620. The design of snap - connecting the stepped snap ring 321 to the stepped hole 623 makes the engagement between the adjustable bending structure 300 and the connecting structure 600 more stable.

[0140] Referring to FIG. 6(a), preferably, two - stage stepped holes are provided inside the distal end of the guiding cylinder 620, namely a first stepped hole located at the distal end and a second stepped hole located at the proximal end. The aperture of the first stepped hole is larger than that of the second stepped hole.

[0141] Referring to FIG. 6(c), two - stage stepped snap rings corresponding to the two - stage stepped holes are provided at the proximal end of the bending adjustment handle 320, namely a first stepped snap ring located at the distal end and a second stepped snap ring located at the proximal end. The outer diameter of the first stepped snap ring is larger than that of the second stepped snap ring.

[0142] In some embodiments, referring to FIGS. 8(a) and 8(b), the delivery handle 220 includes a delivery housing 221 and a cable control assembly.

[0143] The distal end of the delivery housing 221 is connected to the proximal end of the delivery tube 210, and the distal end of the delivery housing 221 is also connected to the proximal end of the connecting structure 600. For example, the delivery housing 221 is integrally connected to the proximal end of the raised ring 640 of the connecting structure 600. The cable control assembly can slide axially on the delivery housing 221 along the axis of the delivery tube 210. The cable control assembly is connected to the clips of the trans - femoral mitral valve clip. When the cable control assembly slides axially, it controls the opening and closing of the clips. The number of cable control assemblies is the same as the number of clips, so that a group of cable control assemblies can control the opening and closing of one clip.

[0144] The cable control assembly includes a cable control end 222, a delivery cable, a cable locking end 223, and an axial engagement member 224.

[0145] The wire control end 222 can slide axially along the conveying pipe 210 on the conveying housing 221. The wire control end 222 is detachably and snap-fitted with the axial snap-fitting member 224. When the axial snap-fitting member 224 is snap-fitted with the wire control end 222, the length of the conveying wire is locked. When it is necessary to pull or convey the conveying wire, the wire control end 222 is separated from the axial snap-fitting member 224, and the wire control end is axially slid to realize pulling or conveying the conveying wire. When the wire control end 222 is snap-fitted with the axial snap-fitting member 224, a rotatable snap head is provided on the wire control end 222. The wire control end 222 is axially slid to the side of the axial snap-fitting member 224, the snap head is rotated and the wire control end 222 is continuously slid. When the snap head is located above the axial snap-fitting member 224, the snap head is released, and the snap head is snap-fitted with the axial snap-fitting member 224. Preferably, a guiding member is provided in the conveying housing 221. The guiding member is slidably connected with the wire control end 222, and the guiding member guides the wire control end 222 to slide axially along the conveying pipe 210.

[0146] The conveying wire extends axially along the conveying pipe 210 and is detachably connected to the clip of the transcatheter mitral valve clip. The wire locking end 223 is arranged on the wire control end 222. The wire locking end 223 slides axially along the conveying pipe 210 following the wire control end 222. The wire locking end 223 locks both ends of the conveying wire to the wire control end 222. When in use, one end of the conveying wire is locked to the wire locking end 223, and the other end extends inside the conveying pipe 210 to the transcatheter mitral valve clip. After being detachably connected to the clip of the transcatheter mitral valve clip, it extends back to the wire locking end 223 and is locked by the wire locking end 223, causing the conveying wire to form a U-shaped structure. When the conveying wire is connected to the clip of the transcatheter mitral valve clip, a wire through hole is provided on the clip of the transcatheter mitral valve clip, and the conveying wire can be detachably connected to the clip of the transcatheter mitral valve clip by bypassing the wire through hole. When it is necessary to separate the conveying structure 200 from the transcatheter mitral valve clip, the locked conveying wire is loosened, and one end of the conveying wire is continuously pulled until the whole wire is pulled out.

[0147] In some embodiments, referring to FIGS. 8(a) and 8(b), the release structure 100 is detachably connected to the transcatheter mitral valve clip, and the release structure 100 can control the connection or separation of the conveying structure 200 and the transcatheter mitral valve clip. The release structure 100 includes a core rod 110, a release control end 120, and a clip control assembly.

[0148] The distal end of the central core rod 110 passes through the delivery tube 210 and is detachably connected to the transcatheter mitral valve clip applier. The connection mode between the central core rod 110 and the transcatheter mitral valve clip applier is one of threaded connection or snap connection. The proximal end of the central core rod 110 is provided with a release control end 120. The central core rod 110 is connected or separated from the transcatheter mitral valve clip applier through the release control end 120. Preferably, the release control end 120 can adopt a release knob, which is fixed to the proximal end of the central core rod 110. By rotating the release knob, the central core rod 110 is driven to rotate to achieve detachable connection or separation from the transcatheter mitral valve clip applier.

[0149] In some embodiments, the clip applier control assembly is used to control the working state of the transcatheter mitral valve clip applier. The working states of the transcatheter mitral valve clip applier mainly include the open state, the umbrella deployment state, and the closed state. These states are achieved by pushing or pulling back the transcatheter mitral valve clip applier through the central core rod 110. The clip applier control assembly can push or pull back the central core rod 110. The clip applier control assembly includes a rotating sleeve 131, a helical tube 132, a central core rod fixing member 133, and a propulsion nut 134.

[0150] The proximal and distal ends of the rotating sleeve 131 are open structures. The inside of the rotating sleeve 131 is hollow. The rotating sleeve 131 is connected to the delivery housing 221. When the rotating sleeve 131 is provided on the delivery housing 221, preferably, a plurality of auxiliary guiding members are provided on the rotating sleeve 131, such as the first guiding member 1311, the second guiding member 1312, and the third guiding member 1313 in FIGS. 8(a), 9(a), and 10(a). The wire control assembly can be provided on the rotating sleeve 131, and the wire control assembly is guided to move axially through the auxiliary guiding members.

[0151] The proximal and distal ends of the helical tube 132 are open structures. The inside of the helical tube 132 is hollow. The helical tube 132 is at least partially located inside the rotating sleeve 131. External threads are provided on the outer wall of the helical tube 132. The proximal end of the helical tube 132 extends out of the rotating sleeve 131 and is detachably connected to the central core rod fixing member 133. When the two are connected, a threaded connection mode can be adopted. The central core rod fixing member 133 is also detachably connected to the central core rod 110. One end of the propulsion nut 134 is threadedly connected to the external threads of the helical tube 132, and the other end of the propulsion nut 134 can move circumferentially along the rotating sleeve 131. The distal end of the central core rod 110 passes through the central core rod fixing member 133, the helical tube 132, and the delivery tube 210 in sequence and is connected to the transcatheter mitral valve clip applier. When the propulsion nut 134 is rotated, since the rotating sleeve 131 does not move, at this time, the helical tube 132 can extend or retract axially into the rotating sleeve 131, driving the central core rod fixing member 133, and further driving the central core rod 110 to be pushed distally or pulled back to control the working state of the transcatheter mitral valve clip applier.

[0152] In some embodiments, referring to FIGS. 9(a) and 9(b), a pin slot 1314 is circumferentially provided on the outer wall of the rotating sleeve 131. An internal thread is provided on the inner wall of the proximal end of the advancing nut 134, and it is threadedly connected to the external thread of the spiral tube 132 through the internal thread. A pin mounting hole 1341 is radially dug at the distal end of the advancing nut 134. The advancing nut 134 is connected to the rotating sleeve 131 by sequentially passing a push pin through the pin mounting hole 1341 and the pin slot 1314, so as to enable the advancing nut 134 to move circumferentially along the rotating sleeve 131.

[0153] In some embodiments, referring to FIGS. 10(a) and 10(b), a sleeve flange 1315 is provided on the outer wall of the proximal end of the rotating sleeve 131. An internal thread is provided on the inner wall of the proximal end of the advancing nut 134, and it is threadedly connected to the external thread of the spiral tube 132 through the internal thread. A nut necking is provided at the distal end of the advancing nut 134. The advancing nut 134 is sleeved outside the sleeve flange 1315 through the nut necking and connected to the rotating sleeve 131, so as to enable the advancing nut 134 to move circumferentially along the rotating sleeve 131.

[0154] In some embodiments, referring to FIGS. 11(a) and 11(b), the loader structure 400 is used for loading the transcatheter mitral valve clip and for the adjustable bend tube 310 to pass through.

[0155] The loader structure 400 includes a loading cavity 410, a loading head 420, and a sealing end structure 430. The proximal and distal ends of the loading cavity 410 are open structures, and the inside of the loading cavity 410 is hollow. The loading cavity 410 can accommodate the transcatheter mitral valve clip and the adjustable bend tube 310, and both the transcatheter mitral valve clip and the adjustable bend tube 310 can pass through the loading cavity 410. The loading cavity 410 is made of one or a mixture of PEBAX, PTFE, polymer materials, and stainless steel. A developing ring is preferably sleeved at the distal end of the loading cavity 410, and the two are fixedly connected by one or a mixture of PEBAX, PTFE, polymer materials, and stainless steel. The developing ring can be made of any one or a mixture of nitinol wire, platinum-iridium wire, and platinum-tungsten wire.

[0156] The loading head 420 is communicated with the proximal end of the loading cavity 410, and the proximal end of the loading head 420 has a loading connection portion 421. The sealing end structure 430 is detachably connected to the loading connection portion 421, and the connection manner between the two can be threaded connection or snap connection, etc. The sealing end structure 430 allows the adjustable bend tube 310 to pass through and is sealingly connected to the adjustable bend tube 310.

[0157] In some embodiments, referring to Figures 11(b) to 12(b), the sealed end structure 430 includes a head nut 431 and a sealing gasket 432. The proximal end face of the head nut 431 has a nut through-hole 4311 that is internally and externally connected. The head nut 431 is detachably connected to the loading connection part 421 and encloses a sealing gasket accommodation cavity with a nut through-hole 4311 at one end. The nut through-hole 4311 can be penetrated by the adjustable bent pipe 310. The sealing gasket 432 is arranged in the sealing gasket accommodation cavity, and the sealing gasket 432 can be penetrated by the adjustable bent pipe 310 and is hermetically connected to the adjustable bent pipe 310.

[0158] In some embodiments, in the present invention, the head nut 431 and the sealing gasket 432 of the sealed end structure 430 can be implemented in a variety of different structures.

[0159] Referring to FIGS. 12(a) and 12(b), the sealing gasket 432 is an elastic variable-diameter pipe body with a contracted middle and expanded ends. The sealing gasket 432 sequentially includes a first expansion part 4321, a contraction part 4322, and a second expansion part 4323 from the proximal end to the distal end. The proximal end of the first expansion part 4321 abuts against the proximal end face of the head nut 431, and the outer wall of the second expansion part 4323 fits against the inner wall of the loading connection part 421.

[0160] In some embodiments, a groove ring 4324 is also sleeved outside the first expansion part 4321, and the outer wall of the groove ring 4324 fits against the circumferential inner wall of the proximal end of the head nut 431. The groove ring 4324 is a sealing ring body. The proximal end of the sealing ring body is connected to the circumferential outer wall of the first expansion part 4321, resulting in a buffer groove being formed between the distal end of the sealing ring body and the circumference of the first expansion part 4321.

[0161] In some embodiments, referring to Figures 1 to 3 , the outer sheath tube structure 500 is used to provide a channel for the adjustable bending structure 300 and the conveying structure 200; the outer sheath tube structure 500 includes an outer sheath tube 510 and a sheath tube handle 520. The outer sheath tube 510 serves as the access channel for the adjustable bent pipe 310 of the adjustable bending structure 300, and the outer sheath tube 510 can be bent. The sheath tube handle 520 is communicated with the outer sheath tube 510, and the sheath tube handle 520 controls the bending degree of the outer sheath tube 510. The structure of the sheath tube handle 520 is the same as that of the bending adjustment handle 320, and will not be described in detail here.

[0162] The present invention is used in cooperation with a trans-femoral mitral valve clip. During use, the delivery wire of the delivery structure 200 is detachably connected to the clip of the trans-femoral mitral valve clip, and the core rod 110 of the release structure 100 is detachably connected to the trans-femoral mitral valve clip. When it is necessary to move the delivery structure 200 axially, it is achieved by rotating the rotating nut 610. When it is necessary to rotate and advance the delivery structure 200 forward, first move the insert piece 660 from the distal end along the insert piece guide groove 613 to the proximal end. After the tip 662 of the insert piece is engaged with the locking teeth 651, then rotate the rotating nut 610 to drive the delivery structure 200 to move forward and backward while rotating.

[0163] The foregoing has shown and described the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. The above embodiments and the descriptions in the specification only illustrate the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

Claims

1. A delivery device for a trans-femoral mitral valve clip, comprising: An adjustable bending structure, having an adjustable bending tube and a bending adjustment handle; A delivery structure, having a delivery tube and a delivery handle; Characterized in that, the delivery device for the trans-femoral mitral valve clip further comprises: A connection structure, capable of performing rotational and translational movements, with the distal end connected to the bending adjustment handle and the proximal end connected to the delivery handle, driving the delivery structure to perform rotational and translational movements; The connection structure includes: A rotating nut, having an internal thread and a circle of nut grooves on the inner wall of the distal end, the nut grooves being located on the distal side of the internal thread, and the rotating nut being provided with an axially penetrating insert guide groove; A guide cylinder, with the distal end connected to the bending adjustment handle and a first snap ring provided at the proximal end, the first snap ring being snap-fitted into the nut groove; An external thread cylinder, having an external thread on the outer wall, the external thread cylinder being threadedly connected to the rotating nut, and the proximal end being connected to the delivery handle; A snap ring, integrally connected to the delivery handle, with the distal end inserted into the proximal end interior of the rotating nut, and a circle of snap teeth provided on the outer wall, the length direction of the snap teeth being axial; An insert, with one end being a pushing end and the other end being an insert tip, the pushing end being located outside the rotating nut, the insert tip passing through the insert guide groove and extending into the interior of the rotating nut, when the pushing end slides proximally along the insert guide groove, the insert tip can be meshed and connected with the snap teeth; when the pushing end slides distally along the insert guide groove, the insert tip can be disengaged from the snap teeth.

2. The delivery device for the trans-femoral mitral valve clip as claimed in claim 1, wherein When the rotating nut rotates by 5° - 20°, the external thread cylinder axially moves by 5 cm - 10 cm.

3. The delivery device for the trans-femoral mitral valve clip as claimed in claim 1, wherein At least one guide rod is axially provided on the inner wall of the guide cylinder; At least one guide groove is axially provided on the outer wall of the external thread cylinder, the distal end of the external thread cylinder is inserted into the guide cylinder, and the guide groove is slidably connected with the guide rod.

4. The delivery device for the trans-femoral mitral valve clip as described in claim 1, wherein A limiting plate is provided at the distal end of the external thread cylinder, and the outer diameter of the limiting plate is greater than the inner diameter of the distal end of the rotating nut.

5. The delivery device for a trans-femoral mitral valve clip as claimed in claim 1, wherein, The connection structure further includes: A convex ring, with the proximal end integrally connected to the delivery handle and having a circle of outer convex grooves on the inner wall; A second snap ring is provided at the proximal end of the external thread cylinder, the proximal end of the external thread cylinder extends into the interior of the convex ring, and the second snap ring is snap-fitted and connected with the outer convex groove.

6. The delivery device for the trans-femoral mitral valve clip as described in claim 1, wherein The snap ring, the convex ring and the delivery handle are integrally connected from the distal end to the proximal end; The proximal end of the external thread cylinder sequentially passes through the snap ring and the convex ring and then is snap-fitted and connected with the outer convex groove.

7. The delivery device for the trans-femoral mitral valve clip as claimed in claim 1, wherein, The insert further includes an insert guiding section, the pushing end is provided at one end of the insert guiding section, and the other end of the insert guiding section is the insert tip; An anti-disengagement plate is provided on the insert guiding section, the anti-disengagement plate is located between the pushing end and the insert tip, the length of the anti-disengagement plate is greater than the width of the insert guide groove, the distance between the anti-disengagement plate and the pushing end is greater than the depth of the insert guide groove, and the anti-disengagement plate is placed inside the rotating nut.

8. The delivery device for the trans-femoral mitral valve clip as described in claim 1, characterized in that, A stepped hole is provided inside the distal end of the guide cylinder; A stepped snap ring corresponding to the stepped hole is provided at the proximal end of the bending adjustment handle, and the stepped snap ring is snap-fitted into the stepped hole to realize the snap connection between the bending adjustment handle and the guiding cylinder.

9. The delivery device for the trans-femoral mitral valve clip as described in claim 1, characterized in that, The delivery handle includes: A delivery housing whose distal end is respectively connected to the proximal end of the delivery tube and the proximal end of the connection structure; A wire control assembly that can slide axially on the delivery housing and is connected to the clip of the transcatheter mitral valve clip. When the wire control assembly slides axially, it controls the opening and closing of the clip; The number of the wire control assemblies is the same as the number of the clips.

10. The delivery device for the trans-femoral mitral valve clip as described in claim 1, characterized in that, The transcatheter mitral valve clip delivery device further includes: A release structure that is detachably connected to the transcatheter mitral valve clip; The release structure includes: A core rod whose distal end passes through the delivery tube and is detachably connected to the transcatheter mitral valve clip. A release control end is provided at the proximal end, and the core rod is connected to or separated from the transcatheter mitral valve clip through the release control end; The release structure further includes: A clip control assembly for controlling the working state of the transcatheter mitral valve clip; The clip control assembly includes: A rotating sleeve whose proximal and distal ends are open structures and are internally hollow, and is connected to the delivery handle; A spiral tube whose proximal and distal ends are open structures and are internally hollow, at least partially located inside the rotating sleeve, with the proximal end extending out of the rotating sleeve, and an external thread is provided on the outer wall; A core rod fixing member that is detachably connected to the core rod and is detachably connected to the proximal end of the spiral tube; A propulsion nut whose one end is threadedly connected to the external thread of the spiral tube, and the other end can move circumferentially along the rotating sleeve; The distal end of the core rod sequentially passes through the core rod fixing member, the spiral tube and the delivery tube and then is connected to the transcatheter mitral valve clip.

11. The delivery device for a trans-femoral mitral valve clip as claimed in claim 1, wherein The transcatheter mitral valve clip delivery device further includes: A loader structure for loading the transcatheter mitral valve clip and allowing the adjustable bending tube to pass through; The loader structure includes: A loading cavity whose proximal and distal ends are open structures and are internally hollow; A loading head that communicates with the proximal end of the loading cavity and has a loading connection portion at the proximal end; A sealing end structure that is detachably connected to the loading connection portion, allows the adjustable bending tube to pass through and is hermetically connected to the adjustable bending tube.

12. The delivery device for the trans-femoral mitral valve clip as claimed in claim 1, wherein The transcatheter mitral valve clip delivery device further includes: An outer sheath tube structure that provides a channel for the adjustable bending structure and the delivery structure; The outer sheath tube structure includes: An outer sheath tube that serves as an access channel for the adjustable bending tube; A sheath tube handle that communicates with the outer sheath tube and controls the bending degree of the outer sheath tube.

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