Implant delivery handle and implant system

Abstract

The invention provides an implant delivery handle and an implant system. The implant system comprises an implant and the implant delivery handle. The implant conveying handle comprises a shell and an inner arm control mechanism arranged on the shell, and the inner arm control mechanism comprises a plurality of first pull rods and locking pieces; each first pull rod can move in the axial direction of the first pull rod so as to control the corresponding inner arm to rotate. The locking piece has a locking state and an unlocking state; when the locking piece is in the locking state, the locking piece can be connected with all the first pull rods, so that all the first pull rods can synchronously move in the axial direction of the first pull rods, and then all the inner arms are controlled to synchronously rotate; when the locking piece is in the unlocking state, the locking piece is disconnected from at least part of the first pull rods, so that the at least two first pull rods can move in the axial direction of the first pull rods correspondingly, and then the at least two inner arms are controlled to rotate correspondingly. The delivery handle can realize accurate positioning, rapid capturing and accurate clamping of the valve leaflet by an implant, so that the operation efficiency and the success rate are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an implant delivery handle and an implant system. Background Art

[0002] According to statistics, the number of people suffering from valvular regurgitation in my country has exceeded 10 million, and the disease usually requires open-chest surgery for treatment. Since open-chest surgery requires extracorporeal circulation and cardiac arrest, it will cause greater surgical trauma to the patient and require a relatively long recovery period. In recent years, the interventional treatment technology for mitral regurgitation has gradually matured, among which the placement of implants in the atrioventricular valve position has a significant therapeutic effect on mitral regurgitation, and has become a new blessing for patients.

[0003] Mitral valve regurgitation is mainly caused by incomplete valve leaflet closure. Interventional treatment can be performed by implanting a "clip"-like implant to clamp the valve leaflet to block the location of incomplete valve leaflet closure, so that the valve leaflet can be repaired "edge to edge" to improve the mitral valve regurgitation phenomenon. Specifically, mitral valve interventional treatment delivers the implant to the diseased valve through a delivery system, and the implant is controlled by a handle to position and capture the valve leaflet.

[0004] Since the entire operation is carried out in an environment where the heart is working normally, the doctor can only observe the positioning and clamping process of the implant through ultrasound images. In addition, the mitral valve opens and closes with the contraction and expansion of the heart, so the handle needs to accurately control the implant when the implant clamps all the leaflets within one or a few heart beat cycles. Moreover, since the location of the leaflet lesions in different patients is different, the clamping position of the implant on the leaflets will also vary with individual patients. Accurately capturing the leaflets requires the implant to have a high clamping accuracy, so the handle also needs to be able to more flexibly control the implant to clamp the leaflets.

[0005] Therefore, for technicians in this field, how to control the implant through the handle to quickly capture the leaflets and accurately clamp the leaflets is a technical problem that needs to be solved urgently. Summary of the invention

[0006] The purpose of the present invention is to provide an implant delivery handle and an implant system, wherein the delivery handle can achieve accurate positioning, rapid capture and precise clamping of the implant on the valve leaflet, thereby improving the efficiency and success rate of the operation.

[0007] To achieve the above-mentioned object, the present invention provides an implant delivery handle for controlling an implant to clamp a target tissue, wherein the implant comprises a plurality of inner arms, the implant delivery handle comprises a shell and an inner arm control mechanism disposed on the shell, the inner arm control mechanism comprises a plurality of first pull rods and a locking member, each of the first pull rods being able to move along its own axial direction to control the rotation of a corresponding inner arm;

[0008] The locking member has a locked state and an unlocked state and can be switched between the locked state and the unlocked state;

[0009] When the locking member is in a locked state, the locking member connects all the first pull rods, so that all the first pull rods can move synchronously along their own axes, thereby controlling all the inner arms to rotate synchronously;

[0010] When the locking member is in an unlocked state, the locking member is disconnected from at least a portion of the first pull rods, so that at least two of the first pull rods can move along their own axes respectively, thereby controlling at least two of the inner arms to rotate respectively.

[0011] Optionally, the inner arm control mechanism further comprises a handle, a proximal end of each of the first pull rods is connected to one of the handles, the handle and the locking element are both arranged outside the housing, and the first pull rod is arranged inside the housing;

[0012] In the locked state, the locking member is connected to all the handles; in the unlocked state, the locking member is connected to only one of the handles and is disconnected from all the other handles.

[0013] Optionally, the inner arm control mechanism further comprises a connecting sleeve, the connecting sleeve is installed on one of the handles along the radial direction of the first pull rod, the connecting sleeve passes through the handle in the radial direction of the first pull rod, and all the other handles are provided with a mounting hole in the radial direction of the first pull rod for inserting the locking member;

[0014] The locking member is partially inserted into the connecting sleeve and is movably connected to the connecting sleeve. The locking member can rotate and move relative to the connecting sleeve to switch between the locking state and the unlocking state.

[0015] Optionally, the locking member is a knob, a limiting protrusion is provided on the outer wall of the locking member, and an arc-shaped sliding groove matching with the limiting protrusion is provided on the side wall of the connecting sleeve;

[0016] After the locking member is driven to rotate, the limiting protrusion can move along the arc-shaped sliding groove, so that the locking member moves in the axial direction of the connecting sleeve, and then switches between the locking state and the unlocking state.

[0017] Optionally, the inner arm control mechanism further includes a first damping ring, which is disposed between the locking member and an inner wall of the connecting sleeve and is used to provide damping between the locking member and the connecting sleeve.

[0018] Optionally, the inner arm control mechanism also includes a pull rod sleeve, the pull rod sleeve having a plurality of accommodating holes independently arranged along its own axial direction, and the distal end of the first pull rod can be movably inserted into a corresponding one of the accommodating holes; the distal end of each of the first pull rods is provided with a sealing sleeve, and the outer wall of the sealing sleeve is provided with an annular sealing flange, and the sealing flange is used to seal the gap between the first pull rod and the accommodating hole.

[0019] Optionally, the outer wall of the first pull rod has a first plane extending along its own axis, the inner wall of the accommodating hole has a second plane corresponding to the position of the first plane, and the first plane is used to cooperate with the second plane to limit the first pull rod in the circumferential direction.

[0020] Optionally, the implant delivery handle further comprises an outer arm control mechanism, the outer arm control mechanism is used to drive the outer arm of the implant to rotate, and the inner arm can cooperate with a corresponding one of the outer arms to clamp the target tissue;

[0021] The outer arm control mechanism includes an operating member, a fixing assembly and an adjusting assembly; the fixing assembly includes a driving rod; one end of the operating member is connected to the outer arm of the implant, and the other end is fixedly connected to the driving rod; the adjusting assembly includes a supporting sleeve, the driving rod can movably pass through the supporting sleeve, and the supporting sleeve is rotatably connected to the shell; the supporting sleeve is used to drive the driving rod to drive the operating member to rotate synchronously.

[0022] Optionally, the adjustment assembly further comprises an adjustment nut, wherein the adjustment nut is threadedly connected to the proximal end of the drive rod extending out of the support sleeve, and the adjustment nut can drive the drive rod to move along its own axial direction after being rotated;

[0023] When the support sleeve rotates, the drive rod can rotate along with the support sleeve and can move along its own axial direction under the limitation of the adjusting nut.

[0024] Optionally, the implant delivery handle further comprises a connection assembly, the connection assembly is arranged in the housing, the connection assembly comprises a main pipeline and two branch pipelines, the two branch pipelines are respectively arranged on opposite sides of the main pipeline along its own axial direction, and each branch pipeline is connected to the main pipeline;

[0025] The inner arm control mechanism also includes a pull rod sleeve; the pull rod sleeve is fixedly connected to one of the branch pipes; the support sleeve is respectively connected to the side walls of the two branch pipes, the drive rod is located on the proximal axis of the main pipe, and the operating member is used to pass through the main pipe and then connect to the drive rod.

[0026] Optionally, the implant delivery handle also includes a withdrawal mechanism; the withdrawal mechanism is used to drive the catheter to move; the proximal end of the withdrawal mechanism is connected to the distal end of the main line, the distal end of the withdrawal mechanism is connected to the proximal end of the catheter, and the distal end of the catheter is detachably connected to the implant; the withdrawal mechanism is used to drive the catheter to move toward the proximal end so as to separate the catheter and the implant.

[0027] Optionally, the withdrawal mechanism includes a connecting seat and a first dial button, the distal end of the connecting seat is fixedly connected to the catheter, and the proximal end of the connecting seat is slidably connected to the main pipeline; a third groove is provided on the shell, the first dial button is located in the third groove, and is used to drive the connecting seat to drive the catheter to move toward the proximal end.

[0028] Optionally, the retracting mechanism further includes a baffle and a second dial button, wherein the baffle is sleeved on the outside of the connecting seat; the housing has a fourth groove, the second dial button is placed in the fourth groove, and is used to drive the baffle to rotate;

[0029] The second dial button has a locked state and an unlocked state; in the locked state, the baffle can axially limit the connecting seat; in the unlocked state, the baffle can release the limit on the connecting seat so that the connecting seat can move along its own axial direction.

[0030] Optionally, the implant delivery device also includes a release mechanism, which includes a second pull rod and a second knob, the distal end of the second pull rod is connected to another one of the branch pipes; the second knob has a trapezoidal internal thread, and the second pull rod has a trapezoidal external thread that matches the trapezoidal internal thread; the second knob is used to drive the second pull rod to move toward the proximal end, and the second pull rod can release the lock between the implant and the catheter after moving.

[0031] To achieve the above objectives, the present invention further provides an implant system, comprising an implant and any one of the implant delivery handles described above, wherein the implant delivery handle is used to deliver the implant to a predetermined position and to control the implant to clamp a target tissue.

[0032] The implant delivery handle and implant system provided by the present invention are used to control the implant to clamp the target tissue. The implant delivery handle includes a shell and an inner arm control mechanism arranged on the shell, and the inner arm control mechanism includes a plurality of first pull rods and a locking member, each of the first pull rods can move along its own axis to control the rotation of a corresponding one of the inner arms; the locking member has a locked state and an unlocked state, and can switch between the locked state and the unlocked state; when the locking member is in the locked state, the locking member connects all the first pull rods so that all the first pull rods can move synchronously along their own axis, thereby controlling all the inner arms to rotate synchronously; when the locking member is in the unlocked state, the locking member is disconnected from at least part of the first pull rods so that at least two of the first pull rods can move separately along their own axis, thereby controlling at least two of the inner arms to rotate separately.

[0033] The inner arm control mechanism of the delivery handle can control the multiple inner arms of the implant to clamp the leaflets synchronously, and can also control the multiple inner arms of the implant to clamp the leaflets separately. This can achieve accurate positioning, rapid capture and precise clamping of the leaflets by the implant, making it easier for doctors to capture the leaflets, and can flexibly capture the leaflets of patients with different shapes, thereby improving surgical efficiency and success rate. At the same time, the implant system is flexible to control and easy to use, which can reduce the difficulty of surgical operations and ensure safety and reliability during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of the three-dimensional structure of a delivery handle in a preferred embodiment of the present invention;

[0035] Figure 2 This is a schematic diagram of the internal structure of a delivery handle in a preferred embodiment of the present invention;

[0036] Figure 3 It is a schematic diagram of a partial axial cross-sectional structure of a delivery handle in a preferred embodiment of the present invention;

[0037] Figure 4 It is a schematic diagram of an axial cross-sectional structure of a delivery handle in another preferred embodiment of the present invention;

[0038] Figure 5 It is a structural schematic diagram of the inner arm control mechanism in a preferred embodiment of the present invention;

[0039] Figure 6 It is a partial structural schematic diagram of the inner arm control mechanism in a preferred embodiment of the present invention;

[0040] Figure 7 It is a schematic diagram of an axial cross-sectional structure of an inner arm control mechanism in a preferred embodiment of the present invention;

[0041] Figure 8 It is a schematic structural diagram of a first pull rod in a preferred embodiment of the present invention;

[0042] Fig. 9 It is a partial structural schematic diagram of the outer arm control mechanism in a preferred embodiment of the present invention;

[0043] Fig.10 It is a schematic diagram of the axial cross-sectional structure of the outer arm control mechanism in a preferred embodiment of the present invention;

[0044] Fig.11 It is a partial structural schematic diagram of a delivery handle in a preferred embodiment of the present invention;

[0045] Fig.12 It is a schematic diagram of a part of the internal structure of the delivery handle in a preferred embodiment of the present invention, wherein the release mechanism is in a locked state;

[0046] Fig.13 It is a partial structural schematic diagram of a connecting mechanism in a preferred embodiment of the present invention;

[0047] Fig.14 It is a three-dimensional structural schematic diagram of a withdrawing mechanism in a preferred embodiment of the present invention;

[0048] Fig.15 It is a right side structural schematic diagram of a withdrawal mechanism in a preferred embodiment of the present invention, wherein the withdrawal mechanism is in a locked state;

[0049] Fig.16 It is a schematic diagram of the axial cross-sectional structure of the withdrawal mechanism in a preferred embodiment of the present invention;

[0050] Fig.17 It is a three-dimensional structural schematic diagram of a release mechanism in a preferred embodiment of the present invention;

[0051] Fig.18 It is a schematic diagram of the axial cross-sectional structure of the release mechanism in a preferred embodiment of the present invention;

[0052] Fig.19 It is a schematic structural diagram of a second pull rod in a preferred embodiment of the present invention;

[0053] Fig. 20 It is a schematic diagram of the initial state structure of the delivery handle in a preferred embodiment of the present invention, wherein the locking member is in a locked state and the second dial button is in a locked state;

[0054] Fig.21 This is a schematic diagram of the structure of an implant before implantation in a preferred embodiment of the present invention, wherein the inner arm and the outer arm are both in a closed state;

[0055] Fig. 22This is a schematic diagram of the structure of the implant after implantation in a preferred embodiment of the present invention, wherein the inner arm is in a closed state and the outer arm is in an open state;

[0056] Fig.23 It is a structural schematic diagram of a delivery handle in another preferred embodiment of the present invention, wherein the locking member is in a locked state, and the second dial button is in a locked state;

[0057] Fig.24 It is a structural schematic diagram of a delivery handle in another preferred embodiment of the present invention, wherein the locking member is in an unlocked state and the second dial button is in a locked state;

[0058] Fig.25 It is a schematic diagram of the structure of the implant after implantation in another preferred embodiment of the present invention, wherein the inner arm is in a synchronously opened state and the outer arm is in an open state;

[0059] Fig.26 This is a schematic diagram of the structure of an implant after implantation in another preferred embodiment of the present invention, wherein the inner arm is in a separate open state and the outer arm is in an open state;

[0060] Fig. 27 It is a schematic diagram of a part of the internal structure of the delivery handle in another preferred embodiment of the present invention, wherein the release mechanism is in an unlocked state;

[0061] Fig.28 It is a right view structural schematic diagram of the withdrawal mechanism in another preferred embodiment of the present invention, wherein the withdrawal mechanism is in an unlocked state;

[0062] Fig.29 It is a schematic structural diagram of a delivery handle in another preferred embodiment of the present invention, wherein the locking member is in an unlocked state and the second dial button is in an unlocked state.

[0063] [Description of reference numerals is as follows]:

[0064] Implant 100; inner arm 101; outer arm 102; connecting rod 103;

[0065] Inner arm control mechanism 1; first pull rod 11; protruding end 111; outlet hole 1111; first limiting hole 1112; sealing sleeve 112; sealing flange 113; first plane 114; locking member 12; limiting protrusion 121; extension portion 122; handle 13; connecting portion 131; second limiting hole 1311; gripping portion 132; connecting sleeve 14; arc-shaped slide groove 141; first annular groove 142; pull rod sleeve 15; accommodating hole 151; hole wall 1511; first section 152; second section 153; first sealing ring 16;

[0066] Shell 2; upper shell 21; lower shell 22; metal ring 23; distal end cover 24; proximal end cover 25; first groove 26; second groove 27;

[0067] Outer arm control mechanism 3; driving rod 31; supporting sleeve 32; adjusting nut 33; rotating knob 34;

[0068] Connecting assembly 4; main pipeline 41; second sealing ring 411; branch pipeline 42; blocking member 43; sealing member 44; drain member 45; withdrawal mechanism 5; connecting seat 51; first receiving groove 511; second receiving groove 512; injection hole 513; flange 514; first shielding portion 515; first dial button 52; baffle 53; second shielding portion 531; second dial button 54; second damping ring 55;

[0069] Release mechanism 6; second pull rod 61; limit block 611; fourth annular groove 612; fifth annular groove 613; second knob 62; one-way valve 63; unlocking member 64. DETAILED DESCRIPTION

[0070] The present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the accompanying drawings are in very simplified form and in non-precise proportions, and are only used to conveniently and clearly assist in explaining the purpose of the embodiments of the present invention.

[0071] The orientation or position relationship indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like are based on the orientation or position relationship shown in the drawings and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operate in a specific orientation, and therefore should not be understood as limiting the present invention.

[0072] In the present invention, unless otherwise clearly specified and limited, the terms "installation", "connection", "fixation" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be directly connected or connected through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances. In the description of the present invention, the meaning of "multiple" is at least two, such as two or three or more, etc.

[0073] As used in this specification, "distal end" generally refers to the end of the delivery handle away from the operator; the term "proximal end" is opposite to the "distal end", and generally refers to the end of the delivery handle close to the operator; the term "axial" refers to the axial direction of the operating member; the term "circumferential" refers to the circumferential direction of the axis of the operating member; the term "radial" refers to the diameter direction of the cross-section of the operating member perpendicular to the axis.

[0074] The present invention is described in detail below in conjunction with the accompanying drawings and preferred embodiments. In the absence of conflict, the following embodiments and features in the embodiments may complement or be combined with each other.

[0075] like Figure 1 and Fig.21 As shown, a preferred embodiment of the present invention provides an implant delivery handle (hereinafter referred to as the delivery handle) for delivering and controlling an implant 100. Specifically, the implant delivery handle is used to deliver the implant 100 to a predetermined position, and to control the implant 100 to clamp the target tissue. It should be known that the predetermined position refers to the target position to which the implant 100 is delivered. In the present embodiment, the predetermined position refers to the position of the mitral valve or the tricuspid valve. It should also be known that the target tissue refers to the clamping site after the implant is implanted, and in the present embodiment, the target tissue refers to the leaflet of the mitral valve or the tricuspid valve.

[0076] like Figure 1 and Fig.21 As shown, a preferred embodiment of the present invention further provides an implant system, including an implant 100 and an implant delivery handle.

[0077] In the following description, the valve leaflet is used as the target tissue for illustration.

[0078] In the prior art, during the leaflet clamping process, the implant 100 needs to clamp all native leaflets. When the symmetry of multiple leaflets is good, the delivery handle can control the implant 100 to achieve synchronous clamping of at least two leaflets. When the symmetry of multiple leaflets is not good or pathological conditions occur, the delivery handle is usually required to control the implant 100 to clamp the multiple leaflets separately, or to control the implant 100 to switch between synchronous clamping of the leaflets and separate clamping of the leaflets when clamping the leaflets. Then, the delivery handle can only control the implant 100 to clamp synchronously or can only control the implant to clamp separately, which may affect the clamping accuracy of the implant 100 to the leaflets. At the same time, poor clamping of the leaflets can easily cause tearing of the leaflets, thereby causing further harm to the patient.

[0079] To solve the above problems, Figures 1 to 8 As shown, combined with Fig.21The delivery handle provided by the present invention comprises an inner arm control mechanism 1 and a housing 2. The inner arm control mechanism 1 is arranged on the housing 2. The inner arm control mechanism comprises a plurality of first pull rods 11 and a locking member 12. The implant 100 has a plurality of inner arms 101 (see Fig.21 ), each first pull rod 11 can move along its own axial direction to control the rotation of a corresponding inner arm 101.

[0080] The locking member 12 has a locked state and an unlocked state, and can switch between the locked state and the unlocked state. When the locking member 12 is in the locked state, the locking member 12 connects all the first pull rods 11 so that all the first pull rods 11 can move synchronously along their own axes, thereby controlling all the inner arms 101 to rotate synchronously. When the locking member 12 is in the unlocked state, the locking member 12 is disconnected from at least part of the first pull rods 11 so that at least two first pull rods 11 can move separately along their own axes, thereby controlling at least two inner arms 101 to rotate separately. At least two inner arms 101 rotate separately means that at least two inner arms 101 can rotate independently of each other. At this time, the inner arm control mechanism 1 can realize independent control and synchronous control of at least two inner arms 101 of the implant 100.

[0081] For more details, see Fig.21 As shown, the implant 100 includes a plurality of outer arms 102, a plurality of inner arms 101 and a connecting rod 103, and the outer arms 102 and the inner arms 101 are both connected to the connecting rod 103. The inner arm control mechanism 1 can control the rotation angle of the inner arm 101 relative to the connecting rod 103. At the same time, when the connecting rod 103 rotates, it can drive the outer arm 102 to rotate around the connecting rod 103. Each outer arm 102 can cooperate with a corresponding inner arm 101 to clamp the valve leaflet. When the angles between the inner arm 101 and the outer arm 102 and the proximal end of the connecting rod 103 are both small (for example, when the angles are close to zero degrees), the inner arm 101 and the outer arm 102 are both in a closed state, and the inner arm 101 and the outer arm 102 can be placed in a delivery handle in this state to achieve delivery in the human body. When the included angles between the inner arm 101 and the outer arm 102 and the proximal end of the connecting rod 103 are both large (e.g., greater than a predetermined rotation angle), the inner arm 101 and the outer arm 102 are both in an open state, in which the inner arm 101 can cooperate with a corresponding outer arm 102 to clamp the valve leaflets. After the implant 100 is implanted in the human body, the gap after the valve leaflets are closed can be eliminated by clamping the valve leaflets to reduce blood reflux.

[0082] In the delivery handle provided by the present invention, the inner arm control mechanism 1 can control the multiple inner arms 101 of the implant 100 to clamp the leaflets synchronously, and can also control the multiple inner arms 101 of the implant 100 to clamp the leaflets separately, so that the implant 100 can accurately position, quickly capture and accurately clamp the leaflets, making it easier for doctors to capture the leaflets, and can flexibly capture the leaflets of patients with different shapes, thereby improving the efficiency and success rate of the operation. At the same time, the implant system is flexible to control and easy to use, which can reduce the difficulty of surgical operation and ensure the safety and reliability during the operation.

[0083] like Figure 1 to Figure 5 As shown, the inner arm control mechanism 1 further includes handles 13, the number of which corresponds to the number of the first pull rods 11, and a handle 13 is connected to the proximal end of each first pull rod 11, and is used to drive a corresponding first pull rod 11 to move along its own axial direction. The handle 13 and the locking member 12 are both arranged outside the housing 2, and the first pull rod 1 is arranged inside the housing 2. In this embodiment, the number of the handles 13 is 2, and in other embodiments, the number of the handles 3 can also be set to 3.

[0084] In the locked state, the locking member 12 is connected to all handles 13, so that all handles 13 are connected as a whole through the locking member 12, so that they can move synchronously to control all inner arms 101 to clamp the leaflets synchronously. In the unlocked state, the locking member 12 is only connected to one handle 13, and is disconnected from all other handles 13. At this time, any handle 13 can move independently relative to the other handles 13, that is, each handle 13 can move separately to control a corresponding inner arm 101 to clamp the leaflets separately. In this way, the operator can have more flexible control options. In the process of driving the implant 100 to capture the leaflets, the operator can put the locking member 12 in a locked state or an unlocked state as needed, so that all handles 13 can switch between synchronous movement and separate movement, so that the corresponding inner arm 101 can be accurately controlled to rotate, so that the inner arm 101 can cooperate with the corresponding outer arm 102 to accurately capture the leaflets, thereby improving the convenience of operation.

[0085] Continue to refer to Figure 6 In one embodiment, the inner arm control mechanism 1 further comprises a connecting sleeve 14. The connecting sleeve 14 is mounted on one handle 13 along the radial direction of the first pull rod 11. The connecting sleeve 14 penetrates the handle 13 in the radial direction of the first pull rod 11. All other handles are provided with mounting holes in the radial direction of the first pull rod 11 for the locking member 12 to be inserted. The mounting holes can be set as through holes or non-through holes. The locking member 12 is partially inserted into the connecting sleeve 14 and is movably connected to the connecting sleeve 14. The locking member 12 can rotate and move relative to the connecting sleeve 14 to switch between a locked state and an unlocked state.

[0086] It should be noted that the connecting sleeve 14 can be installed after being formed separately from the handles 13, or can be integrally formed with one of the handles 13. Preferably, the connecting sleeve 14 is integrally formed with one of the handles 13 to save installation steps.

[0087] In actual use, the locking member 12 can rotate or move relative to the connecting sleeve 14, so that the locking member 12 moves into or out of all the mounting holes of the remaining handles 13, thereby controlling all the handles 13 to move synchronously or separately.

[0088] In one embodiment, the locking member 12 can be configured as a screw and moved into or out of the mounting hole by rotating. In another embodiment, the locking member 12 can also be configured as a pin and moved into or out of the mounting hole by plugging and pulling. The present application does not limit the structure of the locking member 12.

[0089] In a specific embodiment, the locking member 12 is a first knob, a limiting protrusion 121 is provided on the outer wall of the locking member 12, and an arc-shaped slide groove 141 matching with the limiting protrusion 121 is provided on the side wall of the connecting sleeve 14. After the locking member 12 is driven to rotate, the limiting protrusion 121 can move along the arc-shaped slide groove 141, so that the locking member 12 moves in the axial direction of the connecting sleeve 14, and then switches between the locked state and the unlocked state.

[0090] It should be understood that the setting position of the arc groove 141 should be able to ensure that when the limiting protrusion 121 of the locking member 12 moves in the arc groove 141, the locking member 12 can move in and out of all the mounting holes of the remaining handles 13 to control the synchronous movement and separate movement of all the handles 13.

[0091] It should be noted that the angle of the arc-shaped slot 141 can be determined according to the distance that the locking member 12 needs to move in the axial direction of the connecting sleeve 14. For example, in one example, the angle of the arc-shaped slot 141 can be set to 90° to 120°. It should be known that the angle of the arc-shaped slot 141 refers to the angle formed between the two connecting lines of the two ends of the arc-shaped slot 141 and the center of the connecting sleeve 14 on the cross section of the connecting sleeve 14.

[0092] Reference Figure 6 to Figure 8As shown, in this embodiment, the handle 13 includes a connecting portion 131 and a gripping portion 132 connected to each other, and the connecting portion 131 is rod-shaped and connected to the first pull rod 11. In this embodiment, the proximal end of the first pull rod 11 is provided with a protruding end 111, and the distal end of the connecting portion 131 is provided with a recessed end (not numbered). The protruding end 111 is provided with a wire outlet hole 1111 and a first limiting hole 1112 that penetrate in the radial direction, and the recessed end of the connecting portion 131 is provided with a second limiting hole 1311 that penetrates in the radial direction and matches with the first limiting hole 1112. When the first pull rod 11 and the handle 13 are matched, the protruding end 111 can be inserted into the recessed end, and the first limiting hole 1112 and the second limiting hole 1311 are penetrated in the radial direction, and then a positioning pin or a screw can be inserted into the first limiting hole 1112 and the second limiting hole 1311 in sequence to achieve the connection between the first pull rod 11 and the handle 13. Of course, the first pull rod 11 and the handle 13 may also be fixed by gluing, welding or mechanical connection.

[0093] The present application does not limit the structure of the gripping portion 132. The gripping portion 132 is configured to be a structure that is convenient for the operator to hold. The operator can drive the first pull rod 11 to move by pushing or pulling the gripping portion 132. In this embodiment, the gripping portion 132 is configured to be a concave arc structure; in other embodiments, the gripping portion 132 can also be configured to be a circular structure or an annular structure as required.

[0094] like Figure 6 As shown, the locking member 12 is preferably provided with an extension portion 122 extending radially outward, and the operator can rotate the locking member 12 by rotating the extension portion 122. The operator can also judge whether the locking member 12 is in an unlocked state or a locked state by the position of the extension portion 122. For example, when the extension portion 122 is substantially perpendicular to the axis of the first pull rod 11, the locking member 12 is in a locked state, and when the extension portion 122 is substantially parallel to the axis of the first pull rod 11, the locking member 12 is in an unlocked state.

[0095] Preferably, the inner arm control mechanism 1 further includes a first damping ring (not numbered), which is disposed between the locking member 12 and the inner wall of the connecting sleeve 14 and is used to provide damping between the locking member 12 and the connecting sleeve 14. With such a configuration, on the one hand, the operator can have a certain resistance when rotating the locking member 12, thereby having a comfortable hand feel when rotating; on the other hand, when the locking member 12 is stationary, the locking member 12 and the connecting sleeve 14 can be locked, thereby preventing the operator from misoperating and causing the locking member 12 to rotate, thereby simplifying the instrument operation steps, improving the ease of use for doctors, and greatly improving the success rate of surgery.

[0096] like Figure 7As shown, in this embodiment, a first annular groove 142 is provided on the inner wall of the connecting sleeve 14 , and the first damping ring can be placed in the first annular groove 142 and can be interference fit with the locking member 12 .

[0097] Return to reference Figure 1 The housing 2 includes an upper housing 21, a lower housing 22, a metal ring 23 and a distal end cover 24. The upper housing 21 and the lower housing 22 are detachably connected along their own axis to jointly form a gripping portion of the delivery handle. The upper housing 21 and the lower housing 22 can be fixed by a snap-fit ​​structure, screws or pins, or by other connection methods. After the upper housing 21 and the lower housing 22 are connected, the metal ring 23 is sleeved on the distal ends of the upper housing 21 and the lower housing 22. The metal ring 23 is preferably interference fit with the upper housing 21 and the lower housing 22 to increase the connection strength between the upper housing 21 and the lower housing 22. In addition, the metal ring 23 can also be connected in cooperation with an external bracket to support the delivery handle.

[0098] The distal end cap 24 is connected to the distal end of the metal ring 23 to block the distal end of the delivery handle. The distal end cap is preferably threadedly connected to the upper shell 21 and the lower shell 22 that pass through the metal ring 23, so that the axial position of the metal ring 23 can be limited by the distal end cap 24 while the distal end cap 24 is fixed.

[0099] Reference Figure 5 and Figure 6 As mentioned above, in an exemplary embodiment, the inner arm control mechanism 1 further comprises a rod sleeve 15, and the rod sleeve 15 is fixed in the housing 2. The first rod 11 is used to be movably disposed in the rod sleeve 15 at the proximal end of the rod sleeve 15.

[0100] like Figure 6 As shown, in this embodiment, the rod sleeve 15 has a plurality of independently arranged receiving holes 151 along its own axial direction, and each receiving hole 151 passes through the proximal end of the rod sleeve 15. The number of the first rods 11 corresponds to the number of the receiving holes 151, and the distal end of the first rod 11 can be movably inserted into a corresponding receiving hole 151.

[0101] Continue to refer to Figure 7 The distal end of the accommodating hole 151 has a hole wall 1511 arranged along its own radial direction, and the hole wall 1511 is used to limit the moving distance of the first pull rod 11 toward the distal end, that is, when the first pull rod 11 moves in the accommodating hole 151 to contact the hole wall 1511, the first pull rod 11 cannot continue to move toward the distal end, thereby limiting the rotation angle of the inner arm 101 of the implant 100, even if the inner arm 101 cannot continue to rotate after rotating to a certain angle.

[0102] Reference Figure 8As shown, in a preferred embodiment, a sealing sleeve 112 is provided at the distal end of each first pull rod 11. An annular sealing flange 113 is provided on the outer wall of the sealing sleeve 112, and the sealing flange 113 is used to seal the gap between the first pull rod 11 and the inner wall of the receiving hole 151. In this way, when the operator pushes and pulls the first pull rod 11, the seal between the first pull rod 11 and the pull rod sleeve 15 is more stable and reliable.

[0103] In one example, the sealing sleeve 112 and the sealing flange 113 are both made of silicone material, the outer diameter of the sealing flange 113 is larger than the outer diameter of the sealing sleeve 112 , and the first tie rod 11 is sealed by the interference fit between the sealing flange 113 and the tie rod sleeve 15 .

[0104] In one embodiment, the outer wall of the first pull rod 11 has a first plane 114 extending along its own axis, and the inner wall of the accommodating hole 151 has a second plane (unnumbered) corresponding to the position of the first plane 114. The first plane 114 is used to cooperate with the second plane to limit the first pull rod 11 circumferentially, so that the first pull rod 11 can only move axially relative to the pull rod sleeve 15 but cannot rotate.

[0105] In one example, the proximal end of the first pull rod 11 is provided with first planes 114 on opposite sides along its own axial direction, and the inner wall of the accommodating hole 151 has two second planes (unnumbered) matching with the two first planes 114 to further limit the first pull rod 11 circumferentially.

[0106] In this embodiment, the inner arm control mechanism 1 also includes a plurality of control wires (unnumbered). The number of first pull rods 11 and control wires corresponds to the number of inner arms 101. One end of each control wire is connected to a corresponding inner arm 101, and the other end passes through a pull rod sleeve 15 and is connected to a corresponding first pull rod 11. After the first pull rod 11 moves, the corresponding inner arm 101 can be driven to rotate through the control wire.

[0107] In more detail, a cavity (not numbered) for the control wires to pass through is provided in the first pull rod 11 , and each control wire can extend from the outlet hole 1111 after passing through the cavity and be fixedly connected to the proximal end of the first pull rod 11 .

[0108] The present application does not limit the connection method between the proximal end of the control wire and the first pull rod 11. For example, the proximal end of the control wire can be directly wound around the first pull rod 11, or the proximal end of the control wire can be directly fixed to the first pull rod 11 by gluing or mechanical connection.

[0109] The operation process of the inner arm control mechanism 1 is as follows: in the initial state, the locking piece 12 can be rotated to the locking state, at which time the two handles 13 are in a synchronous moving state, and then the two handles 13 are pulled proximally, and each handle 13 drives the corresponding first pull rod 11 and the control wire to move proximally along the axis of the pull rod sleeve 15. After the control wire moves, it can drive an inner arm 101 corresponding to the implant 100 to rotate until the inner arm 101 is in a closed state, that is, the inner arm 101 is rotated to the nearest end and is located in a position roughly parallel to the connecting rod 103. In this state, the inner arm 101 can be placed in the delivery handle for delivery in the human body.

[0110] It should be explained that, in order for the implant 100 to capture the leaflets, the inner arm 101 and the outer arm 102 need to be located on both sides of the leaflets to clamp the leaflets. When the implant 100 reaches the predetermined position, the locking member 12 is locked or unlocked as required, and the handle 13 is pushed toward the distal end to relax the control wire and no longer apply tension to the inner arm 101. The inner arm 101 can rebound under the action of its own elastic force, so that the inner arm 101 is close to the corresponding outer arm 102 and clamps the leaflets together with the corresponding outer arm 102.

[0111] It should be known that when the leaflet is clamped, the control wire may need to be stretched or relaxed multiple times so that the inner arm 101 and the outer arm 102 try to capture the leaflet multiple times until it is successfully captured. During the process, the operator can alternately rotate the locking member 12 to a locked state or an unlocked state as needed to control the two handles 12 to move synchronously or separately to control the rotation of the inner arm 101.

[0112] In a specific example, the control wire can be snap-connected with the inner arm 101. After the implant 100 clamps the valve leaflet, the operator can separate the control wire from the inner arm 101 by pulling the control wire.

[0113] Furthermore, the delivery handle also includes an outer arm control mechanism 3, which is used to drive the outer arm 102 of the implant 100 to rotate, and is also used to control the rotation angle of the outer arm 102 relative to the connecting rod 103. After the outer arm 102 rotates, it can cooperate with a corresponding inner arm 101 to clamp the valve leaflet.

[0114] Reference Figure 9-10As shown, the outer arm control mechanism 3 includes an operating member (unnumbered), a fixing assembly (unnumbered) and an adjusting assembly (unnumbered). The fixing assembly includes a driving rod 31, and the operating member and the driving rod 31 are both placed in the housing 2. One end of the operating member is connected to the outer arm 102 of the implant 100, and the other end is fixedly connected to the driving rod 31. The adjusting assembly includes a supporting sleeve 32, and the driving rod 31 can movably penetrate the supporting sleeve 32, and the supporting sleeve 32 is rotatably connected to the housing 2. The supporting sleeve 32 is used to drive the driving rod 31 to drive the operating member to rotate synchronously. After the operating member rotates, it drives the outer arm 102 of the implant 100 to rotate relative to the connecting rod 103, so that the outer arm 102 is close to one side of the leaflet.

[0115] It should be noted that one end of the manipulation member is detachably connected to the connecting rod 103 of the implant 100, and the other end is detachably connected to the driving rod 31. When the driving rod 31 drives the connecting rod 103 to rotate circumferentially and / or move axially through the manipulation member, the outer arm 102 can rotate relative to the connecting rod 103 under the drive of the connecting rod 103, so that the outer arm 102 is in contact with one side of the leaflet.

[0116] In a preferred example, the housing 2 is used to limit the axial movement of the support sleeve 32. The drive rod 31 is inserted into the support sleeve 32 along its own axial direction and extends out from the distal end and the proximal end of the support sleeve 32. In this embodiment, the outer wall of the support sleeve 32 and the inner wall of the housing 2 are both provided with mutually matching limiting structures, so that the support sleeve 32 can only rotate relative to the housing 2 but cannot move relative to the housing 2 along the axial direction.

[0117] In the prior art, the control of the external arm control mechanism usually requires unlocking before driving. Since the entire surgical process requires multiple adjustments to the external arm control mechanism, it is easy for the doctor to directly operate the external arm control mechanism without unlocking it, resulting in the failure of the device. In severe cases, it may also cause the implant to fall inside the heart, endangering the patient's life. At the same time, due to the complex connection between the implant and the delivery system, the doctor's operation and unlocking process is cumbersome, which will also prolong the operation time and increase the uncertainty of the operation.

[0118] In the present application, the operating member of the outer arm control mechanism 3 can be driven by the adjustment component to rotate, so that the outer arm 102 of the implant 100 rotates and captures the leaflets. In this way, the implant 100 can quickly capture and accurately clamp the leaflets, and can also simplify the surgical operation process, shorten the operation time, reduce the difficulty of surgical operation, improve the efficiency and success rate of the operation, and ensure the safety and reliability during the operation.

[0119] The present application does not limit the structure of the operating member, and the operating member can be set as a rod or wire structure, etc., as long as the operating member can transmit tension, thrust and rotational force. The present application does not limit the fixing method of the operating member and the driving rod 31, and the operating member can also be fixedly connected to the driving rod 31 by gluing, welding or other mechanical connection methods.

[0120] Reference Fig.10 As shown, the adjustment assembly also includes an adjustment nut 33, and an external thread is provided on the drive rod 31. The adjustment nut 33 is threadedly connected to the proximal end of the drive rod 31 passing through the support sleeve 32. After the adjustment nut 33 is rotated, the drive rod 31 can be driven to move along its own axial direction, that is, the circumferential rotation of the adjustment nut 33 is converted into the axial movement of the drive rod 31.

[0121] Reference Fig. 9 , and combined with Figure 2 The housing 2 further includes a proximal end cap 25, which is used to be connected to the proximal end of the support sleeve 32. When the support sleeve 32 rotates, the proximal end cap 25 can be driven to rotate synchronously. In this embodiment, the proximal end of the support sleeve 32 has an external thread, and the proximal end cap 25 has an internal thread that matches the external thread. The proximal end cap 25 is threadedly connected to the proximal end of the support sleeve 32.

[0122] Furthermore, the adjusting nut 33 can be limited between the supporting sleeve 32 and the proximal end cover 25 along its own axial direction, that is, the distal end of the adjusting nut 33 contacts the end surface of the supporting sleeve 32, and the proximal end of the adjusting nut 33 contacts the inner wall of the proximal end cover 25. When the supporting sleeve 32 rotates, the driving rod 31 can rotate along with the supporting sleeve 32, and can move along its own axial direction under the limitation of the adjusting nut 33. Specifically, when the driving rod 31 rotates under the drive of the supporting sleeve 32, since the axial position of the adjusting nut 33 is limited, the driving rod 31 can move along its own axial direction relative to the adjusting nut 33, so that the operating member can be synchronously moved while rotating along its own circumferential direction.

[0123] During actual assembly, the adjusting nut 33 can be rotated to fine-tune the axial position of the operating member so that the operating member moves toward the proximal end and is in a tensioned state, thereby achieving pre-tightening adjustment of the operating member and the implant 100, thereby compensating for part processing errors or assembly errors.

[0124] Reference Figure 2 and Figure 3 As shown, the adjustment assembly further includes a rotating knob 34, which is disposed outside the housing 2 and is used to pass through the housing 2 to connect with the support sleeve 32, and the rotating knob 34 is used to drive the support sleeve 32 to rotate. In actual use, the operator only needs to rotate the rotating knob 34 to drive the operating member to rotate and move synchronously, thereby controlling the rotation of the outer arm 102 of the implant 100.

[0125] Further, refer to Fig.11 As shown, combined with Figure 2 The delivery handle also includes a connecting assembly 4, which is arranged in the shell 2. The connecting assembly 4 includes a main pipeline 41 and two branch pipelines 42. The two branch pipelines 42 are respectively arranged on opposite sides of the main pipeline 41 along its own axial direction, and each branch pipeline 42 is connected to the main pipeline 41.

[0126] Reference Figure 2 As shown, the tie rod sleeve 15 is fixedly connected to one of the branch pipes 42, that is, the inner arm control mechanism 1 is fixed on a branch pipe 42 of the connecting assembly 4, and the control wire of the inner arm control mechanism 1 passes through the main pipe 41, a branch pipe 42, and the tie rod sleeve 15 in sequence and is connected to the first tie rod 11.

[0127] Reference Fig.12 , and combined with Figure 7 The inner arm control mechanism 1 also includes a first sealing ring 16, a first section 152 and a second section 153 connected in sequence from the distal end to the proximal end of the pull rod sleeve 15, an inner diameter of the first section 152 is greater than an inner diameter of the second section 153, the first sealing ring 16 is arranged on the inner wall of the first section 152, and the accommodating hole 151 is located in the second section 152.

[0128] In one example, a second annular groove is provided on the inner wall of the first section 152, and the first sealing ring 16 is provided in the second annular groove. A corresponding branch pipe 42 is used to be inserted into the first section 152, and preferably has an interference fit with the first section 152 to achieve sealing between the pull rod sleeve 15 and the corresponding branch pipe 42.

[0129] Continue to refer to Figure 2 to Figure 4 The housing 2 containing the supporting sleeve 32 is respectively connected to the two branch pipelines 42. The driving rod 31 is located on the proximal axis of the main pipeline 41, and the operating member is used to penetrate the main pipeline 41 and then connect with the driving rod 31.

[0130] Reference Fig.13 As shown, as an optional embodiment, the connection assembly 4 further includes a blocking member 43, and preferably also includes a sealing member 44. The blocking member 43 includes but is not limited to a nut or a cover body, and the blocking member 43 is used to seal the main line 41. The sealing member 43 is arranged between the blocking member 43 and the main line 41 to seal the gap between the main line 41 and the blocking member 43. The operating member passes through the main line 41, the sealing member 44, and the blocking member 43 in sequence from the distal end to the proximal end, and is fixedly connected to the driving rod 31.

[0131] In a preferred embodiment, the proximal end of the main line 41 has a receiving groove (not numbered), the sealing member 44 is placed in the receiving groove, the side surface of the distal end of the sealing member 44 has a certain slope, and the outer diameter of the sealing member 44 gradually increases from the distal end to the proximal end, and the shape of the receiving groove corresponds to the shape of the sealing member 44. When the blocking member 43 enters and blocks the receiving groove, the sealing member 44 is squeezed, so that the sealing member 44 can better seal the gap between the main line 41 and the blocking member 43.

[0132] Continue to refer to Fig.11 As shown, an emptying member 45 is provided on the outer wall of the connecting assembly 4, and one end of the emptying member 45 can be provided on the main pipeline 41 or the branch pipeline 42 and communicated with the main pipeline 41 or the branch pipeline 42. The other end of the emptying member 45 passes through the housing 2 and is used to connect to a suction device (such as a syringe) to evacuate the delivery handle through the suction device.

[0133] The present application does not limit the position and number of the emptying member 45. The emptying member 45 can be set at any position of the connecting assembly 4, preferably on the outer wall of the delivery handle close to the doctor. The emptying member 45 can also be set as a Luer structure. In this case, the doctor can directly select a syringe with a Luer connector to connect to the emptying member 45 to facilitate the sealing and emptying of the delivery handle.

[0134] More preferably, the implant control device further comprises a withdrawal mechanism 5 (see Figure 4 and Fig.14 ), the withdrawal mechanism 5 is used to connect the catheter (not numbered). The proximal end of the withdrawal mechanism 5 is connected to the distal end of the main line 41, and the distal end of the withdrawal mechanism 5 is connected to the proximal end of the catheter, and the distal end of the catheter is detachably connected to the implant 100. The withdrawal mechanism 5 is used to drive the catheter to move toward the proximal end so that the catheter and the implant 100 are separated.

[0135] Furthermore, the implant 100 further includes a connecting piece (not shown), which is movably connected to the connecting rod 103, and the connecting piece is detachably connected to the catheter. The catheter is axially stressed and moves toward the proximal end to separate the catheter and the connecting piece. After the catheter and the connecting piece are separated, the connecting rod 103 and the operating piece are separated automatically, and then the operator withdraws the delivery handle, thereby completing the entire implantation process of the implant 100.

[0136] In a specific example, the connector of the implant 100 and the catheter can be connected by a snap-fit ​​structure, or other forms of connection. After the catheter and the connector of the implant 100 are snap-fitted and unlocked, the withdrawal mechanism 5 drives the catheter to move toward the proximal end to separate the catheter from the connector of the implant 100.

[0137] In another specific example, the operating member and the connecting rod 103 can be buckled together by a hook structure, and radially limited by the catheter, and the operating member and the connecting rod 103 can move synchronously in the axial direction or rotate synchronously in the circumferential direction. When the catheter moves axially relative to the operating member, the catheter is separated from the connecting member to release the radial limitation between the operating member and the connecting rod 103, and the operating member can move in its own radial direction, thereby being released from the connecting rod 103 by itself, so as to achieve the separation of the operating member and the connecting rod 103.

[0138] Reference Figure 14 to Figure 16 As shown, in a preferred case, the withdrawal mechanism 5 includes a connecting seat 51 and a first dial button 52 connected to each other, wherein the connecting seat 51 is located inside the housing 2, and the first dial button 52 is located outside the housing 2. The distal end of the connecting seat 51 is fixedly connected to the catheter, and the proximal end of the connecting seat 51 is slidably connected to the main pipe 41, and the first dial button 52 is used to drive the connecting seat 51 to drive the catheter to move toward the proximal end.

[0139] When the implant 100 is clamping the valve leaflets, the first dial button 52 is located at the most distal end, so that the withdrawal mechanism 5 is in a locked state, and the catheter and the connector are connected. When the implant 100 successfully clamps the valve leaflets, the operator can pull the first dial button 52 toward the proximal end to drive the catheter to move toward the proximal end until the first dial button 52 is located at the most proximal end, so that the withdrawal mechanism is in an unlocked state, and the catheter is separated from the connector of the implant 100.

[0140] Return to reference Figure 1 As a preferred embodiment, the housing 2 has a first groove 26, and the first dial button 52 is placed in the first groove 26. The first groove 26 can limit the first dial button 52 in the axial direction of the connecting seat 51, so that the first dial button 52 can only move within the range limited by the first groove 26, thereby preventing the connecting seat 51 from moving too far and causing damage to the delivery handle.

[0141] In this embodiment, there are two first buttons 52 and two first grooves 26, and the two first buttons 52 are respectively connected to the two opposite sides of the connecting seat 51 along its own axial direction, and each first button 52 is connected to the connecting seat 51 through a connecting rod and can be placed in a corresponding first groove 26. The present application does not limit the number of first buttons 52, and the number of first buttons 52 can also be set to 1, 3 or more as needed.

[0142] Reference Fig.16 As shown, in this embodiment, the proximal end of the connection seat 51 has a first receiving groove 511, and the distal end of the connection seat 51 has a second receiving groove 512. The first receiving groove 511 and the second receiving groove 512 are connected, the catheter is inserted and fixed in the first receiving groove 511, and the main line 41 is inserted in the second receiving groove 512. The first receiving groove 511 is preferably provided with a limiter to limit the movement of the catheter toward the proximal end.

[0143] The present application does not limit the connection method between the catheter and the connection seat 51. In this embodiment, a plurality of glue injection holes 513 communicating with the first receiving groove 511 are provided on the outer wall of the connection seat 51. After the catheter is inserted into the first receiving groove 511, glue can be injected into the glue injection holes 513 to connect the catheter to the connection seat 51. In other embodiments, the catheter and the connection seat 51 can also be fixedly connected by welding or mechanical connection.

[0144] Preferably, a second sealing ring 411 is provided between the connecting seat 51 and the main pipe 41 (see Fig.12 and Fig.16 ), the second sealing ring 411 can preferably be arranged in the third annular groove of the inner wall of the second accommodating groove 512 to achieve sealing when the connecting seat 51 and the main pipeline 41 slide relative to each other.

[0145] In a preferred embodiment, the first sealing ring 16 and the second sealing ring 411 have the same structure. It should be understood that the same structure here includes the same size, shape and material. Preferably, the first sealing ring 16 and the second sealing ring 411 can be set to the same specification to facilitate the management and replacement of multiple sealing rings.

[0146] In the prior art, during the process of clipping the valve leaflets with the implant 100, the implant 100 and the catheter need to be kept in a state of no relative displacement. If there is no locking structure between the implant 100 and the catheter, it is very likely that the implant 100 and the catheter will be separated due to the doctor's misoperation of the catheter, thereby causing the implant 100 to fall off and the operation to fail.

[0147] To solve the above problems, refer to Figure 14-15 As shown, the withdrawing mechanism 5 preferably further includes a baffle 53 and a second dial button 54 . The baffle 53 is sleeved on the outside of the connecting seat 51 , and the second dial button 54 is used to drive the baffle 53 to rotate.

[0148] The second dial button 54 has a locked state and an unlocked state, and can be switched between the locked state and the unlocked state by rotation. In the locked state, the baffle 54 can axially limit the connection seat 51 to restrict the connection seat 51 from moving along its own axial direction; in the unlocked state, the baffle 54 can release the limit on the connection seat 51 to allow the connection seat 51 to move along its own axial direction.

[0149] Return to reference Figure 1 In one embodiment, the shell 2 has a second groove 27 opened along a partial circumference, and the second button 54 is placed in the second groove 27 and is used to be threadedly connected to the baffle 53. The second button 54 can rotate in the second groove 27 and be limited by the inner wall of the second groove 27.

[0150] For more details, see Figure 14 to Figure 16 As shown, combined with Fig.11 The connecting seat 51 includes a flange 514 arranged at the proximal end of the baffle 53, and the connecting seat 51 also includes an outwardly protruding first shielding portion 515 arranged in a partial circumferential direction at the distal end of the baffle 53. The baffle 53 is confined between the flange 514 and the first shielding portion 515 along its own axial direction.

[0151] Preferably, a second shielding portion 531 protruding inward is provided on part of the circumference of the baffle 53 (see Fig.15 ). When the second dial button 54 is rotated to be in a locked state, the second shielding portion 531 corresponds to the first shielding portion 515 to block the connection base 51 with the first shielding portion 515 from moving toward the proximal end. When the second dial button 54 is rotated to be in an unlocked state, the second shielding portion 531 and the first shielding portion 515 are staggered in the circumferential direction. At this time, the second shielding portion 531 can release the blocking of the first shielding portion 515, so that the connection base 51 with the first shielding portion 515 can drive the catheter to move toward the proximal end.

[0152] In this embodiment, there are two first shielding portions 515, which are symmetrically arranged on the outer wall of the connecting seat 51 along the axial direction, and there are two second shielding portions 531, which are symmetrically arranged on the inner wall of the baffle 53 along the axial direction. There is an accommodating channel between the two second shielding portions 531 for the first shielding portion 515 to pass through. When the second dial button 54 is in the unlocked state, the first shielding portion 515 can correspond to the accommodating channel in the axial direction of the connecting seat 51. At this time, the first shielding portion 515 can pass through the accommodating channel between the two adjacent second shielding portions 531 when moving, so that the connecting seat 51 can move toward the proximal end along its own axial direction.

[0153] The present application does not limit the number of the first shielding portion 515 and the second shielding portion 531. The number of the first shielding portion 515 and the second shielding portion 531 can be set to Fig.17 The number of the plurality of digits can be set to two, and can also be set to 1, 3, 4 or more as required.

[0154] Continue to refer to Figure 7 A second damping ring 55 is preferably provided at the position where the second dial button 53 contacts the shell 2. The second damping ring 55 is used to provide damping between the second dial button 54 and the shell 2. With such a configuration, on the one hand, the second dial button 54 can be locked on the shell 2 when it is stationary to prevent the operator from turning the second dial button 54 due to mistaken operation; on the other hand, the damping force when the doctor turns the second dial button 54 can be increased, thereby improving the comfort of the doctor's operation.

[0155] like Figure 17 to Figure 19As shown, the control device further includes a release mechanism 6, which includes a second pull rod 61 and a second knob 62, and the distal end of the second pull rod 61 is connected to another one of the branch pipes 42. The second knob 62 is used to drive the second pull rod 61 to move toward the proximal end, and the second pull rod 61 can release the lock between the implant 100 and the catheter after moving.

[0156] The present application does not limit the position where the two branch lines 42 are connected to the main line 41. Preferably, the branch line 42 connected to the inner arm control mechanism 1 is closer to the operator to facilitate the doctor's control of the implant 100 clamping the valve leaflet process.

[0157] Preferably, the second knob 62 has a trapezoidal internal thread, and the second pull rod 61 has a trapezoidal external thread matching the trapezoidal internal thread, so that the second pull rod 61 and the second knob 62 are engaged through the trapezoidal thread. This can improve the stability of the short-stroke wire control of the release line, allowing the doctor to more accurately control the withdrawal of the release line.

[0158] Continue to refer to Fig.17 and Fig.18 In a preferred embodiment, the release mechanism 6 includes a release line (not numbered), the distal end of the release line is connected to the distal end of the catheter, and the proximal end of the release line is fixedly connected to the second pull rod 61. The second knob 62 is used to be rotatably connected to the housing 2, and the housing 2 can also axially limit the second knob 62 so that the second knob 62 cannot move relative to the housing 2. After the second knob 62 is rotated, it can drive the second pull rod 61 to move toward the proximal end, that is, the rotational movement of the second knob 62 is converted into the axial movement of the second pull rod 61 relative to the second knob 62. After the second pull rod 61 moves, it can drive the release line to move toward the proximal end to release the lock between the implant 100 and the catheter. After the catheter and the implant 100 are unlocked, the withdrawal mechanism 5 drives the catheter to move toward the proximal end to separate the catheter and the implant 100.

[0159] The cooperation between the release mechanism 6 and the withdrawal mechanism 5 can facilitate the rapid separation of the delivery handle from the implant 100, so as to improve the convenience of unlocking and releasing the delivery handle. At the same time, the release mechanism 6 and the withdrawal mechanism 5 are sensitive to control and easy to use, which can simplify the surgical operation process, reduce the difficulty of surgical operation, improve surgical efficiency and shorten the operation time.

[0160] In actual operation, after the implant 100 has clamped the valve leaflet, the operator first needs to pull the release line toward the proximal end through the second pull rod 61, and the release line can pull the distal end of the catheter to achieve the clamping unlocking of the catheter and the implant 100. Then the operator can turn the second dial button 54 to put the baffle 53 in the unlocked state, and then move the first dial button 52 toward the proximal end to achieve the separation of the catheter and the implant 100.

[0161] In this embodiment, a wire outlet slot (not numbered) is provided on the side of the trapezoidal thread at the proximal end of the second rod 61, and the release wire is inserted from the distal end of the second rod 61, and can be passed out at the wire outlet slot at the proximal end of the second rod 61 and fixedly connected to the second rod 61. The fixing method of the release wire to the proximal end of the second rod 61 includes but is not limited to gluing or mechanical connection.

[0162] like Fig.19 As shown, a limit block 611 is provided on the outer wall of the second pull rod 61, and a limit groove (not numbered) is provided at a position corresponding to the limit block 611 of the shell 2. The limit block 611 can only move in the limit groove, thereby limiting the moving distance of the second pull rod 61 in its own axial direction.

[0163] Reference Fig.19 As described, the distal end of the second rod 61 is sleeved with a third sealing ring, and the third sealing ring is used to seal the gap between the second rod 61 and the branch pipeline 42. In this embodiment, the distal outer wall of the second rod 61 has a fourth annular groove 612, and the third sealing ring is located in the fourth annular groove 612. The proximal end of the second rod 61 is sleeved with a fourth sealing ring, and the proximal outer wall of the second rod 61 has a fifth annular groove 613, and the fourth sealing ring is located in the fifth annular groove 613, and the fourth sealing ring is used to seal the gap between the second rod 61 and the second knob 62.

[0164] In an exemplary embodiment, the third sealing ring and the fourth sealing ring have the same structure. It should be understood that the same structure here includes the same size, shape and material. Preferably, the third sealing ring and the fourth sealing ring can be set to the same specification to facilitate the management and replacement of multiple sealing rings.

[0165] In a preferred embodiment, the release mechanism 6 further includes a one-way valve 63, which is detachably connected to the proximal end of the second knob 62, and the second pull rod 61 has a hollow chamber, and the one-way valve 63 is connected to the chamber of the second pull rod 61. The one-way valve 63 is also used to connect with an external mechanism (such as a vacuum device) to achieve the emptying of the gas in the delivery handle, which can solve the problem of difficulty in exhausting gas due to the vacuum chamber in the delivery handle. After the gas in the delivery handle is exhausted, the external mechanism connected to the one-way valve 63 can be removed to prevent the external mechanism from affecting the operator's operation.

[0166] In one example, the proximal end of the second knob 62 is further provided with a Luer connector, which can be Luer-connected to the one-way valve 63. In other examples, the second knob 62 and the one-way valve 63 can also be connected by gluing or clamping, which is not specifically limited.

[0167] In a preferred embodiment, the release mechanism 6 further includes an unlocking member 64 (see Fig.18), the second pull rod 61 is provided with a second through hole (not numbered) penetrating the chamber in the radial direction, and the unlocking member 64 is used to penetrate the second through hole. The unlocking member 64 can prevent misoperation and prevent the catheter from being accidentally released, so as to improve the safety of the operation. The unlocking member 64 includes but is not limited to structures such as a limit screw, a limit pin, and a limit rod.

[0168] The unlocking member 64 has a first state and a second state, and can be switched between the first state and the second state by rotation. When the unlocking member 64 is in the first state, the unlocking member 64 can penetrate into the second through hole and abut against the second pull rod 61. At this time, the unlocking member 64 can limit the axial movement of the second pull rod 61, so that the release mechanism 6 is in a locked state. When the unlocking member 64 is in the second state, the unlocking member 64 is separated from the second pull rod 61 by rotation. At this time, the unlocking member 64 cannot limit the movement of the second pull rod 61, so that the release mechanism 6 is in an unlocked state. In this state, the operator can drive the second pull rod 61 to move along its own axial direction by rotating the second knob 62, and the release line can move axially under the drive of the second pull rod 61.

[0169] The following is a brief description of the working process of the implant system. The implant 100 is delivered to the vicinity of the patient's mitral valve via a delivery handle. When the leaflets of the mitral valve are aligned edge to edge, the catheter and the implant 100 are separated and the delivery handle is withdrawn from the body. The implant 100 remains at the leaflets to achieve "edge to edge repair" of the mitral valve.

[0170] For any of the above embodiments, in a non-limiting operation, taking mitral valve replacement as an example, the implantation process of the implant 100 is:

[0171] 1) Preoperative preparation

[0172] Before the implant 100 is implanted into the human body, the connecting rod 103 is first connected to the operating member, and the connecting member of the implant 100 is connected to the catheter. At the same time, one end of the control wire is connected to the inner arm 101 of the implant 100, and the other end is connected to the first pull rod 11 through the housing 2. One end of the release wire is connected to the distal end of the catheter, and the other end is connected to the second pull rod 61 through the housing 2, thereby completing the connection between the implant 100 and the delivery handle;

[0173] Before the proximal end cover 25 is installed, the adjusting nut 33 of the inner arm control mechanism 3 is rotated to put the operating member in a pre-tightened state, and then the proximal end cover 25 is installed at the proximal end of the support sleeve 32;

[0174] Reference Fig.21 and Fig.21As shown, the locking member 12 of the inner arm control mechanism 1 is rotated to make the two handles 13 move synchronously, and the two handles 13 are pulled toward the proximal end to the extreme position, so that the inner arm 101 of the implant 100 is retracted (that is, the angle between the inner arm 101 and the connecting rod 103 is minimized);

[0175] Rotate the rotation knob 34 to make the support sleeve 32 drive the operating member to rotate, so that the outer arm 102 of the implant 100 is retracted (that is, the angle between the outer arm 102 and the connecting rod 103 is minimized);

[0176] The unlocking member 64 is rotated circumferentially to put the unlocking member 64 in the first state and put the release mechanism 6 in the locked state to limit the movement of the second pull rod 61;

[0177] The second dial button 54 is rotated circumferentially to put the withdrawing mechanism 5 into a locked state to limit the movement of the connecting seat 51;

[0178] The implant 100 is placed in the delivery handle.

[0179] 2) Capture the leaflets

[0180] Delivering the implant 100 to the diseased valve of the mitral valve via a delivery handle;

[0181] Reference Fig. 22 As shown, the rotation knob 34 of the outer arm control mechanism 3 is rotated so that the support sleeve 32 drives the operating member to rotate and move toward the distal end, so as to drive the outer arm 102 of the implant 100 to rotate. The opening angle of the outer arm 102 is determined according to the actual situation; the rotation angle of the outer arm 102 relative to the connecting rod 103 and the implantation depth of the implant 100 are adjusted until the inner side of the outer arm 103 of the implant 100 fits with one side of the leaflet;

[0182] Push the corresponding handle 13 toward the distal end. Since the control wire is bent and no longer pulls the inner arm 101 of the implant 100, the inner arm 101 rebounds by its own elasticity until it cooperates with the corresponding outer arm 102 to clamp a corresponding leaflet.

[0183] During the process of capturing the leaflets, the operator rotates the locking member 12 and controls the handle 13 as many times as needed to switch the locking member 12 between the locked state and the unlocked state, so that the two handles 13 move synchronously (refer to Fig.23 ) or move state separately (refer to Fig.24 ) so that all inner arms 101 can rotate synchronously (refer to Fig.25 ) or rotate separately (refer to Fig.26 ); The operator usually needs to control each handle 13 multiple times to enable the implant 100 to accurately clamp all the leaflets.

[0184] After all leaflets are clamped, the rotation knob 34 of the outer arm control mechanism 3 is rotated again to retract the outer arm 102 of the implant 100, thereby completing the fixation of the implant 100 at the mitral valve position.

[0185] 3) The liberation process

[0186] Reference Fig. 27 As shown, to operate the release mechanism 6, firstly, the unlocking member 64 is rotated circumferentially to put the unlocking member 64 in the second state, at which time the unlocking member 64 no longer restricts the movement of the second pull rod 61, so that the release mechanism 6 is in the unlocked state;

[0187] The second knob 62 of the release mechanism 6 is rotated in the circumferential direction, and the second knob 62 drives the second pull rod 61 to drive the release wire to move toward the proximal end. After the release wire moves, the distal end of the catheter is pulled to release the lock between the catheter and the implant 100;

[0188] Reference Fig.28 and Fig.29 As shown, the withdrawal mechanism 5 is operated, and the second dial button 54 is turned to put the withdrawal mechanism 5 in an unlocked state; then the first dial button 52 is pulled toward the proximal end, and the first dial button 52 drives the catheter to move toward the proximal end through the connecting seat 51, so that the catheter is separated from the implant 100;

[0189] After the catheter is separated from the implant 100, the operating member is automatically separated from the connecting rod 103 of the implant 100. After the implant 100 is released from the catheter, the control wire is also separated from the inner arm 101;

[0190] The delivery handle is withdrawn from the patient's body, thereby completing the entire implantation process of implant 100.

[0191] In summary, in the delivery handle and delivery system provided by the present invention, the inner arm control mechanism 1 can control the multiple inner arms 101 of the implant 100 to clamp the leaflets synchronously, and can also control the multiple inner arms 101 of the implant 100 to clamp the leaflets separately, so that the implant 100 can accurately position, quickly capture and accurately clamp the leaflets, making it easier for doctors to capture the leaflets, and can flexibly capture the leaflets of patients with different shapes, thereby improving the efficiency and success rate of the operation. At the same time, the delivery system is flexible to control and easy to use, which can reduce the difficulty of surgical operation and ensure the safety and reliability during the operation.

[0192] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. An implant delivery handle for controlling an implant to clamp a target tissue, the implant comprising a plurality of inner arms, characterized in that: The implant delivery handle comprises a shell and an inner arm control mechanism disposed on the shell, wherein the inner arm control mechanism comprises a plurality of first pull rods and a locking member, and each of the first pull rods can move along its own axial direction to control the rotation of a corresponding inner arm; The locking member has a locked state and an unlocked state and can be switched between the locked state and the unlocked state; When the locking member is in a locked state, the locking member connects all the first pull rods, so that all the first pull rods can move synchronously along their own axes, thereby controlling all the inner arms to rotate synchronously; When the locking member is in an unlocked state, the locking member is disconnected from at least a portion of the first pull rods, so that at least two of the first pull rods can move along their own axes respectively, thereby controlling at least two of the inner arms to rotate respectively.

2. The implant delivery handle according to claim 1, characterized in that: The inner arm control mechanism further comprises a handle, a proximal end of each of the first pull rods is connected to one of the handles, the handle and the locking element are both arranged outside the housing, and the first pull rod is arranged inside the housing; In the locked state, the locking member is connected to all the handles; in the unlocked state, the locking member is connected to only one of the handles and is disconnected from all the other handles.

3. The implant delivery handle according to claim 2, characterized in that: The inner arm control mechanism further comprises a connecting sleeve, the connecting sleeve is installed on one of the handles along the radial direction of the first pull rod, the connecting sleeve passes through the handle in the radial direction of the first pull rod, and all the other handles are provided with a mounting hole in the radial direction of the first pull rod for inserting the locking member; The locking member is partially inserted into the connecting sleeve and is movably connected to the connecting sleeve. The locking member can rotate and move relative to the connecting sleeve to switch between the locking state and the unlocking state.

4. The implant delivery handle according to claim 3, characterized in that: The locking member is a first knob, a limiting protrusion is arranged on the outer wall of the locking member, and an arc-shaped sliding groove matching with the limiting protrusion is arranged on the side wall of the connecting sleeve; After the locking member is driven to rotate, the limiting protrusion can move along the arc-shaped sliding groove, so that the locking member moves in the axial direction of the connecting sleeve, and then switches between the locking state and the unlocking state.

5. The implant delivery handle according to claim 4, characterized in that: The inner arm control mechanism further includes a first damping ring, which is disposed between the locking member and an inner wall of the connecting sleeve and is used to provide damping between the locking member and the connecting sleeve.

6. The implant delivery handle according to claim 2, characterized in that: The inner arm control mechanism also includes a pull rod sleeve, which has a plurality of accommodating holes independently arranged along its own axial direction, and the distal end of the first pull rod can be movably inserted into a corresponding one of the accommodating holes; the distal end of each of the first pull rods is provided with a sealing sleeve, and the outer wall of the sealing sleeve is provided with an annular sealing flange, and the sealing flange is used to seal the gap between the first pull rod and the accommodating hole.

7. The implant delivery handle according to claim 6, wherein: The outer wall of the first pull rod has a first plane extending along its own axis, the inner wall of the accommodating hole has a second plane corresponding to the position of the first plane, and the first plane is used to cooperate with the second plane to limit the first pull rod in the circumferential direction.

8. The implant delivery handle according to any one of claims 1 to 7, characterized in that: It also includes an outer arm control mechanism, the outer arm control mechanism is used to drive the outer arm of the implant to rotate, and the inner arm can cooperate with a corresponding one of the outer arms to clamp the target tissue; The outer arm control mechanism includes an operating member, a fixing assembly and an adjusting assembly; the fixing assembly includes a driving rod; one end of the operating member is connected to the outer arm of the implant, and the other end is fixedly connected to the driving rod; the adjusting assembly includes a supporting sleeve, the driving rod can movably pass through the supporting sleeve, and the supporting sleeve is rotatably connected to the shell; the supporting sleeve is used to drive the driving rod to drive the operating member to rotate synchronously.

9. The implant delivery handle of claim 8, wherein: The adjusting assembly further comprises an adjusting nut, wherein the adjusting nut is threadedly connected to the proximal end of the driving rod extending out of the supporting sleeve, and the adjusting nut can drive the driving rod to move along its own axial direction after being rotated; When the support sleeve rotates, the drive rod can rotate along with the support sleeve and can move along its own axial direction under the limitation of the adjusting nut.

10. The implant delivery handle of claim 8, wherein: It also includes a connecting assembly, which is arranged in the housing, and includes a main pipeline and two branch pipelines, the two branch pipelines are respectively arranged on opposite sides of the main pipeline along its own axial direction, and each branch pipeline is connected to the main pipeline; The inner arm control mechanism also includes a pull rod sleeve; the pull rod sleeve is fixedly connected to one of the branch pipes; the support sleeve is respectively connected to the side walls of the two branch pipes, the drive rod is located on the proximal axis of the main pipe, and the operating member is used to pass through the main pipe and then connect to the drive rod.

11. The implant delivery handle of claim 10, wherein: It also includes a withdrawal mechanism; the withdrawal mechanism is used to connect the catheter; the proximal end of the withdrawal mechanism is connected to the distal end of the main line, the distal end of the withdrawal mechanism is connected to the proximal end of the catheter, and the distal end of the catheter is detachably connected to the implant; the withdrawal mechanism is used to drive the catheter to move toward the proximal end so that the catheter and the implant are separated.

12. The implant delivery handle of claim 11, wherein: The withdrawal mechanism includes a connecting seat and a first dial button, the distal end of the connecting seat is fixedly connected to the catheter, and the proximal end of the connecting seat is slidably connected to the main pipeline; a third groove is provided on the shell, the first dial button is located in the third groove, and is used to drive the connecting seat to drive the catheter to move toward the proximal end.

13. The implant delivery handle of claim 11, wherein: The retracting mechanism further comprises a baffle and a second dial button, wherein the baffle is sleeved on the outside of the connecting seat; the housing has a fourth groove, the second dial button is placed in the fourth groove and is used to drive the baffle to rotate; The second dial button has a locked state and an unlocked state; In the locked state, the baffle can limit the connection seat axially; in the unlocked state, the baffle can release the limit on the connection seat so that the connection seat can move along its own axial direction.

14. The implant delivery handle of claim 11, wherein: It also includes a release mechanism, which includes a second pull rod and a second knob, the distal end of the second pull rod is connected to another one of the branch pipes; the second knob has a trapezoidal internal thread, and the second pull rod has a trapezoidal external thread that matches the trapezoidal internal thread; the second knob is used to drive the second pull rod to move toward the proximal end, and the second pull rod can release the lock between the implant and the catheter after moving.

15. An implant system, characterized in that: It comprises an implant and an implant delivery handle as described in any one of claims 1 to 14, wherein the implant delivery handle is used to deliver the implant to a predetermined position and to control the implant to clamp a target tissue.

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