Conveying device and conveying system

Abstract

The invention provides a delivery device and a delivery system. The delivery system comprises an implant and the delivery device. The conveying device is used for controlling an implant to clamp target tissue, the implant comprises a plurality of outer arms and a plurality of inner arms, the conveying device comprises an outer arm control mechanism and a shell, and the outer arm control mechanism is arranged on the shell; the outer arm control mechanism comprises a control piece, a fixing assembly and an adjusting assembly. One end of the operating part is used for being connected with an outer arm of the implant, and the other end of the operating part is used for being detachably connected with the fixing assembly; the adjusting assembly is used for driving the fixing assembly to drive the control piece to rotate synchronously. The operating piece is used for driving the outer arm of the implant to rotate after rotating, and the outer arm can be matched with the corresponding inner arm to clamp target tissue. According to the conveying device, precise positioning, rapid capturing and precise clamping of a valve leaflet by an implant can be achieved, and then 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 a conveying device and a conveying system. Background Art

[0002] Mitral regurgitation disease is mainly caused by valve leaflet insufficiency. The treatment methods for this disease mainly include traditional open-chest surgery and minimally invasive interventional surgery. Minimally invasive interventional surgery has been widely used in clinical surgery due to its advantages of small trauma and fast recovery. Minimally invasive interventional treatment of mitral regurgitation disease mainly involves placing an implant at the location of the diseased valve, controlling the implant to clamp the valve leaflets through a delivery device, and blocking the location of the valve leaflet insufficiency to improve the mitral valve regurgitation phenomenon.

[0003] In the prior art, the control of the outer arm control mechanism in the delivery device needs to be driven after unlocking each time. Since the entire surgical process requires multiple adjustments to the outer arm control mechanism, it is easy for the doctor to directly operate the outer arm control mechanism without unlocking it, resulting in the failure of the device. In severe cases, it may also cause the implant to fall in 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 unlocking and operation process is cumbersome, which will also prolong the operation time and increase the uncertainty of the operation.

[0004] Therefore, for those skilled in the art, there is an urgent need for a delivery device that is easy to operate, safe and reliable, and can control the implant to quickly capture the leaflets and accurately clamp the leaflets. Summary of the invention

[0005] The purpose of the present invention is to provide a delivery device and a delivery system to achieve accurate positioning, rapid capture and precise clamping of the valve leaflets by the implant, thereby improving the efficiency and success rate of the operation.

[0006] To achieve the above-mentioned purpose, the present invention provides a conveying device for controlling an implant to clamp a target tissue, wherein the implant includes a plurality of outer arms and a plurality of inner arms; the conveying device includes an outer arm control mechanism and a shell, and the outer arm control mechanism is arranged on the shell; the outer arm control mechanism includes an operating member, a fixing assembly and an adjusting assembly; one end of the operating member is used to be connected to the outer arm of the implant, and the other end is used to be detachably connected to the fixing assembly; the adjusting assembly is used to drive the fixing assembly to drive the operating member to rotate synchronously; after the operating member rotates, it is used to drive the outer arm of the implant to rotate, and the outer arm can cooperate with a corresponding one of the inner arms to clamp the target tissue.

[0007] Optionally, the fixing assembly includes a driving rod; the driving rod is used to be connected to the other end of the operating rod; the adjusting assembly includes a supporting sleeve, which is rotatably connected to the shell; the driving rod can movably pass through the supporting sleeve, and the supporting sleeve is used to drive the driving rod to drive the operating member to rotate synchronously.

[0008] 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.

[0009] Optionally, the housing further comprises a proximal end cover, and the proximal end cover is used to be connected to the proximal end of the support sleeve; the adjusting nut can be limited in its own axial direction between the support sleeve and the proximal end cover;

[0010] 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.

[0011] Optionally, a first connecting member extending radially thereof is provided on the outer wall of the driving rod, and a second connecting member cooperating with the first connecting member is provided on the inner wall of the supporting sleeve; after the supporting sleeve rotates, the driving rod and the operating member having the first connecting member are driven to rotate through the second connecting member.

[0012] Optionally, the first connecting member is a protrusion, and the second connecting member is a first groove; the distal end of the first groove has a groove wall arranged along its own radial direction, and the groove wall is used to limit the moving distance of the driving rod toward the distal end.

[0013] Optionally, the fixing assembly further comprises a fastener, the driving rod has an inner cavity arranged along its own axis, and the operating member is inserted into the inner cavity at the distal end of the driving rod; the fastener is used to be rotatably connected to the distal end of the driving rod after the operating member is inserted into the inner cavity, until the driving rod squeezes and fixes the operating member. Optionally, the distal end of the driving rod also has a second groove arranged along its own axis, and the second groove is connected to the inner cavity; the fastener is a fixing nut, and a circular clamping portion is arranged on the inner wall of the fastener;

[0014] When the fixing nut is sleeved on the distal end of the driving member and moves toward the proximal end, the distance of the second groove along the circumference of the driving rod is gradually reduced under the limitation of the clamping portion until the driving rod can fix the operating member.

[0015] Optionally, the outer arm control mechanism further includes a damping ring, wherein the damping ring is disposed between the support sleeve and the shell, and the damping ring is used to provide damping between the support sleeve and the shell.

[0016] Optionally, the conveying device further comprises an inner arm control mechanism disposed on the housing, the inner arm control mechanism comprising a plurality of first pull rods and a locking member; each of the first pull rods can move along its own axial direction to control the rotation of a corresponding inner arm;

[0017] 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 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 axes, thereby controlling all the inner arms to rotate synchronously;

[0018] 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.

[0019] Optionally, the conveying device further comprises a connecting assembly, the connecting assembly is arranged in the housing, the connecting 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;

[0020] The supporting sleeves are respectively connected to the side walls of the two branch pipelines, the driving rod is located on the proximal axis of the main pipeline, and the operating member is used to penetrate the main pipeline and then connect to the driving rod.

[0021] Optionally, the delivery device 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.

[0022] 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.

[0023] 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;

[0024] 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.

[0025] 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.

[0026] To achieve the above objectives, the present invention further provides a delivery system, comprising an implant and any one of the delivery devices described above, wherein the delivery device is used to deliver the implant to a predetermined position and to control the implant to clamp a target tissue.

[0027] The present invention provides a conveying device and a conveying system, wherein the conveying device comprises an outer arm control mechanism and a shell, wherein the outer arm control mechanism is arranged on the shell; the outer arm control mechanism comprises an operating member, a fixing assembly and an adjusting assembly; one end of the operating member is used to be connected to the outer arm of the implant, and the other end is used to be detachably connected to the fixing assembly; the adjusting assembly is used to drive the fixing assembly to drive the operating member to rotate synchronously; after the operating member rotates, it is used to drive the outer arm of the implant to rotate, and the outer arm can cooperate with the inner arm of a corresponding implant to clamp the target tissue.

[0028] The operating member and the fixing assembly of the outer arm control mechanism of the delivery device can be driven by the adjustment assembly to rotate synchronously, so that the outer arm of the implant rotates and captures the valve leaflets. This can achieve rapid capture and precise clamping of the valve leaflets by the implant, simplify the surgical operation process, shorten the operation time, reduce the difficulty of the surgical operation, improve the surgical efficiency and success rate, and ensure the safety and reliability during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 It is a schematic diagram of the three-dimensional structure of a conveying device in a preferred embodiment of the present invention;

[0030] Figure 2 It is a schematic diagram of the internal structure of a conveying device in a preferred embodiment of the present invention;

[0031] Figure 3 It is a schematic diagram of a partial axial cross-sectional structure of a conveying device in a preferred embodiment of the present invention;

[0032] Figure 4 It is a schematic diagram of an axial cross-sectional structure of a conveying device in another preferred embodiment of the present invention;

[0033] Figure 5 It is a partial structural schematic diagram of the outer arm control mechanism in a preferred embodiment of the present invention;

[0034] Figure 6 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;

[0035] Figure 7 It is a schematic structural diagram of a driving rod in a preferred embodiment of the present invention;

[0036] Figure 8 for Figure 7 A magnified view of part A;

[0037] Fig. 9 It is a partial structural schematic diagram of a conveying device in a preferred embodiment of the present invention;

[0038] Fig.10 It is a schematic diagram of a part of the internal structure of the conveying device in a preferred embodiment of the present invention, wherein the release mechanism is in a locked state;

[0039] Fig.11 It is a partial structural schematic diagram of a connecting mechanism in a preferred embodiment of the present invention;

[0040] Fig.12 It is a three-dimensional structural schematic diagram of a withdrawing mechanism in a preferred embodiment of the present invention;

[0041] Fig.13 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;

[0042] Fig.14 It is a schematic diagram of the axial cross-sectional structure of the withdrawal mechanism in a preferred embodiment of the present invention;

[0043] Fig.15 It is a three-dimensional structural schematic diagram of a release mechanism in a preferred embodiment of the present invention;

[0044] Fig.16 It is a schematic diagram of the axial cross-sectional structure of the release mechanism in a preferred embodiment of the present invention;

[0045] Fig.17 It is a schematic structural diagram of a second pull rod in a preferred embodiment of the present invention;

[0046] Fig.18 It is a schematic diagram of the initial state structure of the conveying device 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;

[0047] Fig.19 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;

[0048] Fig. 20 This 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;

[0049] Fig.21 It is a structural schematic diagram of a conveying device 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;

[0050] Fig. 22 It is a structural schematic diagram of a conveying device 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;

[0051] Fig.23 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;

[0052] Fig.24 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;

[0053] Fig.25 It is a schematic diagram of a part of the internal structure of the conveying device in another preferred embodiment of the present invention, wherein the release mechanism is in an unlocked state;

[0054] Fig.26 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;

[0055] Fig. 27 It is a schematic structural diagram of a conveying device 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.

[0056] [Description of reference numerals is as follows]:

[0057] Implant 100; outer arm 101; inner arm 102; connecting rod 103;

[0058] Outer arm control mechanism 1; driving rod 11; first connecting member 111; second groove 112; supporting sleeve 12; second connecting member 121; groove wall 122; adjusting nut 13; recess 123; rotating knob 14; fastener 15; clamping portion 151; first damping ring 16;

[0059] Shell 2; upper shell 21; lower shell 22; metal ring 23; distal end cover 24; proximal end cover 25; third groove 26; fourth groove 27;

[0060] Inner arm control mechanism 3; first pull rod 31; locking member 32; pull rod sleeve 33; first sealing ring 34;

[0061] 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; glue 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;

[0062] Release mechanism 6; second pull rod 61; limit block 611; second annular groove 612; third annular groove 613; second knob 62; one-way valve 63; unlocking member 64. DETAILED DESCRIPTION

[0063] 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.

[0064] 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.

[0065] 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.

[0066] As used in this specification, "distal end" generally refers to the end of the delivery device away from the operator; the term "proximal end" is opposite to the "distal end", and generally refers to the end of the delivery device 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.

[0067] 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.

[0068] like Figure 1 and Fig.19 As shown, a preferred embodiment of the present invention provides a delivery device for controlling an implant 100 to clamp a target tissue. Specifically, the delivery device is used to deliver the implant 100 to a predetermined position, and is used 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 delivery 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.

[0069] A preferred embodiment of the present invention further provides a delivery system, including an implant 100 and a delivery device.

[0070] In the following description, the valve leaflet is used as the target tissue for illustration.

[0071] Reference Figure 1 to Figure 4 As shown, the delivery device provided by the present invention includes an outer arm control mechanism 1 and a housing 2, wherein the outer arm control mechanism 1 is disposed on the housing 2. The implant 100 includes a plurality of outer arms 101 and a plurality of inner arms 102 (see Fig.19 ).

[0072] Reference Figures 5 to 8As shown, the outer arm control mechanism 1 includes a manipulation member (not shown), a fixing assembly and an adjustment assembly. One end of the manipulation member is connected to the outer arm 101 of the implant 100, and the other end is detachably connected to the fixing assembly. The adjustment assembly is used to drive the fixing assembly to drive the manipulation member to rotate synchronously. After the manipulation member rotates, it is used to drive the outer arm 101 of the implant 100 to rotate, and the outer arm 101 can cooperate with a corresponding inner arm 102 to clamp the target tissue.

[0073] In the present application, the operating member and the fixing assembly of the outer arm control mechanism 1 can be driven by the adjusting assembly to rotate, so that the outer arm 101 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 the surgical operation, improve the surgical efficiency and success rate, and ensure the safety and reliability during the operation.

[0074] For more details, see Fig.19 As shown, the implant 100 further includes a connecting rod 103, and both the outer arm 101 and the inner arm 102 are connected to the connecting rod 103. When the operating member of the outer arm control mechanism 1 rotates, the connecting rod 103 can be driven to rotate, and when the connecting rod 103 rotates, the outer arm 101 of the implant 100 can be driven to rotate relative to the connecting rod 103, and when the outer arm 101 rotates, it can cooperate with a corresponding inner arm 102 to clamp the valve leaflet.

[0075] When the angles between the inner arm 102 and the outer arm 101 and the proximal end of the connecting rod 103 are relatively small (for example, when the angles are close to zero), the inner arm 102 and the outer arm 101 are both in a closed state, and the inner arm 102 and the outer arm 101 can be placed in a conveying device in this state to achieve delivery in the human body. When the angles between the inner arm 102 and the outer arm 101 and the proximal end of the connecting rod 103 are relatively large (for example, when they are greater than a predetermined rotation angle), the inner arm 102 and the outer arm 101 are both in an open state, and in this state the inner arm 102 can cooperate with a corresponding outer arm 101 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 the backflow of blood.

[0076] like Figure 5 and Figure 6 As shown, the fixing assembly includes a driving rod 11, and the operating member and the driving rod 11 are both placed in the housing 2, and the driving rod 11 is used to connect with the other end of the operating rod. The adjusting assembly includes a supporting sleeve 12, and the supporting sleeve 12 is rotatably connected to the housing 2. The driving rod 11 can movably penetrate the supporting sleeve 12, and the supporting sleeve 12 is used to drive the driving rod 11 to drive the operating member to rotate synchronously. After the operating member rotates, the outer arm 101 of the implant 100 is driven to rotate relative to the connecting rod 103, so that the outer arm 101 is close to one side of the leaflet.

[0077] It should be noted that one end of the operating member is detachably connected to the connecting rod 103 of the implant 100, and the other end is detachably connected to the driving rod 11. When the operating member drives the connecting rod 103 to rotate along its own circumferential direction, the outer arm 101 can be driven by the connecting rod 103 to rotate relative to the connecting rod 103, so that the outer arm 101 is in contact with one side of the leaflet.

[0078] In a preferred example, the housing 2 is used to limit the axial movement of the support sleeve 12. The drive rod 11 is inserted into the support sleeve 12 along its own axial direction and extends out from the distal end and the proximal end of the support sleeve 12. In this embodiment, the outer wall of the support sleeve 12 and the inner wall of the housing 2 are both provided with mutually matching limiting structures, so that the support sleeve 12 can only rotate relative to the housing 2 but cannot move relative to the housing 2 along the axial direction.

[0079] 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., and it is only necessary that the operating member can transmit pulling force, pushing force and rotational force.

[0080] like Figure 6-7 As shown, a first connecting member 111 extending in the radial direction of the driving rod 11 is provided on the outer wall thereof, and a second connecting member 121 matching with the first connecting member 111 is provided on the inner wall of the supporting sleeve 12. After the supporting sleeve 12 rotates, the driving rod 11 having the first connecting member 111 and the operating member are driven to rotate through the second connecting member 121, thereby realizing the synchronous rotation of the supporting sleeve 12, the driving rod 11 and the operating member.

[0081] In a specific embodiment, the first connecting member 111 is a protrusion, and the second connecting member 121 is a first groove. The protrusion can be inserted into the first groove, so that when the support sleeve 12 rotates, the driving rod 11 with the protrusion and the operating member can be driven to rotate synchronously through the first groove.

[0082] The present application does not limit the number of the protrusions and the first grooves. In the present embodiment, the number of the protrusions and the first grooves are both four. The four protrusions are evenly distributed in the circumference of the driving rod 11. The position of the first groove corresponds to the position of the protrusion to ensure the stability of the driving rod 11 and the supporting sleeve 12 when they rotate in coordination.

[0083] The present application does not limit the fixing method of the operating member and the driving rod 11 , and the operating member can also be fixedly connected to the driving rod 11 by gluing, welding or other mechanical connection methods.

[0084] Preferably, the distal end of the first groove has a groove wall 122 arranged along its radial direction (refer to Figure 6), the groove wall 122 is used to limit the moving distance of the driving rod 11 toward the distal end, that is, when the driving rod 11 moves in the first groove to contact with the groove wall 122, the driving rod 11 cannot continue to move toward the distal end, thereby limiting the rotation angle of the outer arm 101 of the implant 100 relative to the connecting rod 103, and the outer arm 101 can find the best position to fit the leaflet by rotating within the limited rotation angle.

[0085] 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 conveying device. 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 conveying device.

[0086] The distal end cap 24 is connected to the distal end of the metal ring 23 to block the distal end of the delivery device. 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.

[0087] Reference Figure 6 As shown, the adjustment assembly also includes an adjustment nut 13, and an external thread is provided on the drive rod 11. The adjustment nut 13 is threadedly connected to the proximal end of the drive rod 11 passing through the support sleeve 12. After the adjustment nut 13 is rotated, the drive rod 11 can be driven to move along its own axial direction, that is, the circumferential rotation of the adjustment nut 13 is converted into the axial movement of the drive rod 11.

[0088] Reference 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 12. When the support sleeve 12 rotates, the proximal end cap 25 can be driven to rotate synchronously. In this embodiment, the proximal end of the support sleeve 12 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 12.

[0089] Furthermore, the adjusting nut 13 can be limited along its own axial direction between the supporting sleeve 12 and the proximal end cover 25, that is, the distal end of the adjusting nut 13 contacts the end surface of the supporting sleeve 12, and the proximal end of the adjusting nut 13 contacts the inner wall of the proximal end cover 25. When the supporting sleeve 12 rotates, the driving rod 11 can rotate along with the supporting sleeve 12, and can move along its own axial direction under the limitation of the adjusting nut 13. Specifically, when the driving rod 11 rotates under the drive of the supporting sleeve 12, since the axial position of the adjusting nut 13 is limited, the driving rod 11 can move along its own axial direction relative to the adjusting nut 13, so that the operating member can be synchronously moved while rotating along its own circumferential direction.

[0090] During actual assembly, the adjusting nut 13 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.

[0091] Reference Figure 2 and Figure 3 As shown, the adjustment assembly further includes a rotating knob 14, which is disposed outside the housing 2 and is used to pass through the housing 2 and connect with the support sleeve 12, and the rotating knob 14 is used to drive the support sleeve 12 to rotate. In actual use, the operator only needs to rotate the rotating knob 14 to drive the operating member to rotate and move synchronously, thereby controlling the rotation of the outer arm 101 of the implant 100.

[0092] In this embodiment, the rotating knob 14 is annular and is used to be sleeved on the outside of the supporting sleeve 12. The outer wall of the supporting sleeve 12 is provided with a recess 123 (refer to Figure 5 ), a convex portion matching with the concave portion 123 is provided on the rotating knob 14, and the convex portion can be placed in the concave portion 123 to achieve synchronous rotation of the rotating knob 14 and the supporting sleeve 12. In other embodiments, a convex portion may be provided on the outer wall of the supporting sleeve 12, and a concave portion matching with the convex portion may be provided on the rotating knob 14.

[0093] Reference Figure 6 to Figure 8 As shown, the fixing assembly further includes a fastener 15. The driving rod 11 has an inner cavity (not numbered) arranged along its axial direction, and the operating member is inserted into the inner cavity at the distal end of the driving rod 11. The fastener 15 is used to be rotatably connected to the distal end of the driving rod 11 after the operating member is inserted into the inner cavity until the driving rod 11 squeezes and fixes the operating member.

[0094] like Figure 6 to Figure 8In a specific embodiment, the distal end of the driving rod 11 also has a second groove 112 arranged along its own axial direction, and the second groove 112 is connected to the inner cavity of the driving rod 11. The second groove 112 can divide the distal end of the driving rod 11 into multiple parts in the circumferential direction. The fastener 15 is a fixing nut, and a circular clamping portion 151 is provided on the inner wall of the fastener 15. When the fixing nut is sleeved on the distal end of the driving rod 11 and moves toward the proximal end, the distance of the second groove 112 along the circumferential direction of the driving rod 11 is gradually reduced under the limitation of the clamping portion 151 until the driving rod 11 can fix the operating member.

[0095] In this embodiment, the distal end of the driving rod 11 is a conical structure, and the outer diameter of the conical structure increases from the distal end to the proximal end. The proximal end of the clamping portion 151 of the fixing nut has an internal thread, and the inner diameter of the clamping portion 151 is larger than the distal outer diameter of the conical structure and smaller than or equal to the proximal outer diameter of the conical structure. The driving rod 11 is provided with external threads from the proximal end of the second groove 112 to the proximal end of the driving rod 11, so that the distal end of the driving rod 11 can be threadedly engaged with the fastener 15, and the proximal end of the driving rod 11 can be threadedly engaged with the adjusting nut 13. When the fixing nut is sleeved on the distal end of the driving member 321 and rotated toward the proximal end, the distance of the second groove 112 along the circumference of the driving rod 11 is gradually reduced under the limitation of the clamping portion 151. That is to say, the multiple parts of the driving rod 11 divided by the second groove 112 approach each other under the movement of the fixing nut, so that the inner diameter of the distal end of the driving rod 11 is gradually reduced until the distal end of the driving rod 11 can squeeze and fix the operating member.

[0096] Preferably, the number of the second grooves 112 is multiple (for example Figure 8 4 of them), multiple second grooves 112 are evenly distributed in the circumferential direction of the conical structure, so that when the fixing nut gradually compresses the distal end of the driving rod 11, the multiple parts formed by the distal end of the driving rod 11 can synchronously squeeze and fix the operating member to ensure firm fixation.

[0097] As a preferred embodiment, the outer arm control mechanism 1 further includes a first damping ring 16 (see Figure 5 and Figure 6 ), the first damping ring 16 is arranged between the support sleeve 12 and the housing 2, and the first damping ring 16 is used to seal the gap between the support sleeve 12 and the housing 2, and to provide damping between the support sleeve 12 and the housing 2. With such arrangement, on the one hand, the support sleeve 12 can be driven to rotate relative to the housing 2; on the other hand, when the outer arm 101 rotates to the required angle, the support sleeve 12 stops rotating, and the friction force generated by the pressure of the first damping ring 16 can achieve the locking of the support sleeve 12, so as to prevent the operator from misoperating and causing the rotation of the rotating knob 14, and can also simplify the operation steps of the conveying device, improve the operability of doctors, and improve the success rate of the operation.

[0098] Reference Figure 2 As shown, the conveying device further comprises an inner arm control mechanism 3 arranged on the housing 2 , and the inner arm control mechanism 3 can control the rotation angle of the inner arm 102 relative to the connecting rod 103 .

[0099] Furthermore, the inner arm control mechanism 3 includes a plurality of first pull rods 31 and locking members 32, each of which can move along its own axis to control the rotation of a corresponding inner arm 102. Each outer arm 101 can cooperate with a corresponding inner arm 102 to clamp the leaflet.

[0100] The locking member 32 has a locked state and an unlocked state, and can switch between the locked state and the unlocked state. When the locking member 32 is in the locked state, the locking member 32 connects all the first pull rods 31 so that all the first pull rods 31 can move synchronously along their own axes, thereby controlling all the inner arms 102 to rotate synchronously. When the locking member 32 is in the unlocked state, the locking member 32 is disconnected from at least part of the first pull rods 31 so that at least two first pull rods 31 can move separately along their own axes, thereby controlling at least two inner arms 102 to rotate separately. At least two inner arms 102 rotate separately means that at least two inner arms 102 can rotate independently of each other. At this time, the inner arm control mechanism 3 can realize independent control and synchronous control of at least two inner arms 102 of the implant 100.

[0101] In the delivery device provided by the present invention, the inner arm control mechanism 3 can control the multiple inner arms 102 of the implant 100 to clamp the leaflets synchronously, and can also control the multiple inner arms 102 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.

[0102] Reference Figure 2 As mentioned above, in an exemplary embodiment, the inner arm control mechanism 3 further includes a rod sleeve 33, and the rod sleeve 33 is fixed in the housing 2. The first rod 31 is used to be movably disposed in the rod sleeve 33 at the proximal end of the rod sleeve 33.

[0103] Further, refer to Fig. 9 As shown, combined with Figure 2 The conveying device also includes a connecting component 4, which is arranged in the shell 2. The connecting component 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.

[0104] Reference Figure 2 As shown, the rod sleeve 33 is fixedly connected to one of the branch pipes 42, that is, the inner arm control mechanism 3 is fixed to a branch pipe 42 of the connecting assembly 4. The inner arm control mechanism 3 also includes a control wire for controlling the movement of the inner arm 102, and the control wire passes through the main pipe 41, a branch pipe 42, and the rod sleeve 33 in sequence and is connected to the first rod 31.

[0105] Continue to refer to Figure 2 to Figure 4 The housing 2 containing the supporting sleeve 12 is respectively connected to the two branch pipelines 42. The driving rod 11 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 11.

[0106] Reference Fig.11 As shown, as an optional embodiment, the connection assembly 4 further includes a plugging member 43, and preferably also includes a sealing member 44. The plugging member 43 includes but is not limited to a nut or a cover body, and the plugging member 43 is used to seal the main line 41. The sealing member 43 is arranged between the plugging member 43 and the main line 41 to seal the gap between the main line 41 and the plugging member 43. The operating member passes through the main line 41, the sealing member 44, and the plugging member 43 in sequence from the distal end to the proximal end, and is fixedly connected to the driving rod 11.

[0107] 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.

[0108] Continue to refer to Fig. 9 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 conveying device through the suction device.

[0109] 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 device 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 sealing and emptying of the delivery device.

[0110] More preferably, the control device further comprises a withdrawal mechanism 5, which is used to connect a 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.

[0111] 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 device, thereby completing the entire implantation process of the implant 100.

[0112] 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.

[0113] In a 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. At this time, 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.

[0114] Reference Figure 12 to Figure 14 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.

[0115] 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 5 is in an unlocked state, and the catheter is separated from the connector of the implant 100.

[0116] Return to reference Figure 1As a preferred embodiment, the housing 2 has a third groove 26, and the first button 52 is placed in the third groove 26. The third groove 26 can limit the first button 52 in the axial direction of the connecting seat 51, so that the first button 52 can only move within the range limited by the third groove 26, thereby preventing the connecting seat 51 from moving too far and causing damage to the conveying device.

[0117] In this embodiment, there are two first buttons 52 and two third 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 third 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.

[0118] Reference Fig.14 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.

[0119] 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.

[0120] Preferably, a second sealing ring 411 is provided between the connecting seat 51 and the main pipe 41 (see Fig.10 and Fig.14 ), the second sealing ring 411 can preferably be arranged in the first 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.

[0121] In a preferred embodiment, the first sealing ring 34 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 34 and the second sealing ring 411 can be set to the same specification to facilitate the management and replacement of multiple sealing rings.

[0122] 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.

[0123] To solve the above problems, refer to Figure 12-13 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.

[0124] 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 rotating. In the locked state, the baffle 53 can axially limit the connection seat 51 to limit the connection seat 51 from moving along its own axial direction; in the unlocked state, the baffle 53 can release the limit on the connection seat 51 to allow the connection seat 51 to move along its own axial direction.

[0125] Return to reference Figure 1 In one embodiment, the shell 2 has a fourth groove 27 opened along a partial circumference, the second dial button 54 is placed in the fourth groove 27 and is used to be threadedly connected to the baffle 53, and the second dial button 54 can rotate in the fourth groove 27 and be limited by the inner wall of the fourth groove 27.

[0126] For more details, see Figure 12 to Figure 14 As shown, combined with Fig. 9 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.

[0127] Preferably, a second shielding portion 531 protruding inward is provided on part of the circumference of the baffle 53 (see Fig.13 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.

[0128] 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.

[0129] 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.13 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.

[0130] Continue to refer to Fig.13 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.

[0131] like Figure 15 to Figure 17 As 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.

[0132] 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 3 is closer to the operator to facilitate the doctor's control of the implant 100 clamping the valve leaflet process.

[0133] 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.

[0134] Continue to refer to Fig.15 and Fig.16In 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.

[0135] The cooperation between the release mechanism 6 and the withdrawal mechanism 5 can facilitate the rapid separation of the delivery device from the implant 100, so as to improve the convenience of unlocking and releasing the delivery device. 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.

[0136] 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.

[0137] 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.

[0138] like Fig.17 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.

[0139] Reference Fig.17As described, the distal end of the second pull rod 61 is sleeved with a third sealing ring (not shown), and the third sealing ring is used to seal the gap between the second pull rod 61 and the branch pipeline 42. In this embodiment, the distal outer wall of the second pull rod 61 has a second annular groove 612, and the third sealing ring is located in the second annular groove 612. The proximal end of the second pull rod 61 is sleeved with a fourth sealing ring, and the proximal outer wall of the second pull rod 61 has a third annular groove 613, and the fourth sealing ring is located in the third annular groove 613, and the fourth sealing ring is used to seal the gap between the second pull rod 61 and the second knob 62.

[0140] 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.

[0141] 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 conveying device, which can solve the problem of difficulty in exhausting gas due to the presence of a vacuum chamber in the conveying device. After the gas in the conveying device 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.

[0142] 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.

[0143] In a preferred embodiment, the release mechanism 6 further includes an unlocking member 64 (see Fig.16 ), 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.

[0144] 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.

[0145] The following is a brief description of the working process of the delivery system. The implant 100 is delivered to the vicinity of the patient's mitral valve by the delivery device. When the leaflets of the mitral valve are aligned edge to edge, the catheter and the implant 100 are separated and the delivery device is withdrawn from the body. The implant 100 remains at the leaflets to achieve "edge to edge repair" of the mitral valve.

[0146] 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:

[0147] 1) Preoperative preparation

[0148] 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 102 of the implant 100, and the other end passes through the housing 2 to connect to the first pull rod 31. One end of the release wire is connected to the distal end of the catheter, and the other end passes through the housing 2 to connect to the second pull rod 61, thereby completing the connection between the implant 100 and the delivery device;

[0149] Before the proximal end cover 25 is installed, the adjusting nut 13 of the outer arm control mechanism 1 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 12;

[0150] Reference Fig.18 and Fig.19 As shown, the locking member 32 of the inner arm control mechanism 3 is rotated to make the two first pull rods 31 in a synchronous moving state, and the two first pull rods 31 are pulled toward the proximal end to the extreme position, so that the inner arm 102 of the implant 100 is retracted (that is, the angle between the inner arm 102 and the connecting rod 103 is minimized);

[0151] Rotate the rotation knob 14 to make the support sleeve 12 drive the operating member to rotate, so that the outer arm 101 of the implant 100 is retracted (that is, the angle between the outer arm 101 and the connecting rod 103 is minimized);

[0152] 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;

[0153] 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;

[0154] Implant 100 is placed in a delivery device.

[0155] 2) Capture the leaflets

[0156] Delivering the implant 100 to the diseased valve of the mitral valve via a delivery device;

[0157] Reference Fig. 20 As shown, the rotating knob 14 of the outer arm control mechanism 1 is rotated so that the support sleeve 12 drives the operating member to rotate and move toward the distal end, so as to drive the outer arm 101 of the implant 100 to rotate. The opening angle of the outer arm 101 is determined according to the actual situation; the rotation angle of the outer arm 101 relative to the connecting rod 103 and the implantation depth of the implant 100 are adjusted until the inner side of the outer arm 101 of the implant 100 fits with one side of the leaflet;

[0158] The corresponding first pull rod 312 is pushed toward the distal end. Since the control wire is bent, the inner arm 102 of the implant 100 is no longer pulled. The inner arm 102 rebounds by its own elasticity until it cooperates with the corresponding outer arm 101 to clamp a corresponding leaflet.

[0159] During the process of capturing the leaflets, the operator rotates the locking member 32 as many times as needed and controls the first pull rod 31 to switch the locking member 32 between the locked state and the unlocked state, so that the two first pull rods 31 move synchronously (see Fig.21 ) or move status separately (refer to Fig. 22 ) so that all inner arms 102 can rotate synchronously (refer to Fig.23 ) or rotate separately (refer to Fig.24 ). The operator usually needs to control each first pull rod 31 multiple times to enable the implant 100 to accurately clamp all the leaflets.

[0160] After all the leaflets are clamped, the rotating knob 14 of the outer arm control mechanism 1 is rotated again to retract the outer arm 101 of the implant 100, thereby completing the fixation of the implant 100 at the mitral valve position.

[0161] 3) The liberation process

[0162] 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 this 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;

[0163] Reference Fig.25 As shown, the second knob 62 of the release mechanism 6 is rotated circumferentially, 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;

[0164] Reference Fig.26 and Fig. 27 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;

[0165] 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 102;

[0166] The delivery device is withdrawn from the patient's body, thereby completing the entire implantation process of implant 100.

[0167] In summary, in the delivery device and delivery system provided by the present invention, the operating member and the fixing assembly of the outer arm control mechanism 1 of the delivery device can be driven by the adjusting assembly to rotate, so that the outer arm 101 of the implant 100 rotates and then 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 surgical efficiency and success rate, and ensure the safety and reliability during the operation.

[0168] 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. A delivery device for controlling an implant to grip a target tissue, the implant comprising a plurality of outer arms and a plurality of inner arms, It is characterized in that The conveying device includes an outer arm control mechanism and a shell, and the outer arm control mechanism is arranged on the shell; the outer arm control mechanism includes an operating member, a fixing assembly and an adjusting assembly; one end of the operating member is used to be connected to the outer arm of the implant, and the other end is used to be detachably connected to the fixing assembly; the adjusting assembly is used to drive the fixing assembly to drive the operating member to rotate synchronously; after the operating member rotates, it is used to drive the outer arm of the implant to rotate, and the outer arm can cooperate with a corresponding one of the inner arms to clamp the target tissue.

2. The conveying device according to claim 1, It is characterized in that The fixing assembly includes a driving rod; the driving rod is used to be connected to the other end of the operating rod; the adjusting assembly includes a supporting sleeve, and the supporting sleeve is rotatably connected to the shell; the driving rod can movably pass through the supporting sleeve, and the supporting sleeve is used to drive the driving rod to drive the operating member to rotate synchronously.

3. The conveying device according to claim 2, It is characterized in that The adjustment assembly also includes an adjustment nut, which is threadedly connected to the proximal end of the drive rod extending out of the support sleeve. The adjustment nut can drive the drive rod to move along its own axial direction after being rotated.

4. The conveying device according to claim 3, It is characterized in that The housing further comprises a proximal end cover, which is used to be connected to the proximal end of the support sleeve; the adjusting nut can be limited in its own axial direction between the support sleeve and the proximal end cover; 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.

5. The conveying device according to claim 2, It is characterized in that The outer wall of the driving rod is provided with a first connecting piece extending in its radial direction, and the inner wall of the supporting sleeve is provided with a second connecting piece matching with the first connecting piece; after the supporting sleeve rotates, the driving rod having the first connecting piece and the operating piece are driven to rotate through the second connecting piece.

6. The conveying device according to claim 5, It is characterized in that The first connecting member is a protrusion, and the second connecting member is a first groove; the distal end of the first groove has a groove wall arranged along its own radial direction, and the groove wall is used to limit the moving distance of the driving rod toward the distal end.

7. The conveying device according to claim 2, It is characterized in that The fixing assembly also includes a fastener, the driving rod has an inner cavity arranged along its own axis, and the operating member is inserted into the inner cavity at the distal end of the driving rod; the fastener is used to be rotatably connected to the distal end of the driving rod after the operating member is inserted into the inner cavity until the driving rod squeezes and fixes the operating member.

8. The conveying device according to claim 7, It is characterized in that The distal end of the driving rod also has a second groove arranged along its own axial direction, and the second groove is communicated with the inner cavity; the fastener is a fixing nut, and a circular clamping portion is arranged on the inner wall of the fastener; When the fixing nut is sleeved on the distal end of the driving member and moves toward the proximal end, the distance of the second groove along the circumference of the driving rod is gradually reduced under the limitation of the clamping portion until the driving rod can fix the operating member.

9. The conveying device according to claim 2, It is characterized in that The outer arm control mechanism further includes a damping ring, which is disposed between the support sleeve and the housing, and is used to provide damping between the support sleeve and the housing.

10. The conveying device according to claim 1, It is characterized in that It also includes an inner arm control mechanism disposed on the housing, the inner arm control mechanism including a plurality of first pull rods and a locking member; 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.

11. The conveying device according to claim 2, It is characterized in that 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 supporting sleeves are respectively connected to the side walls of the two branch pipelines, the driving rod is located on the proximal axis of the main pipeline, and the operating member is used to penetrate the main pipeline and then connect to the driving rod.

12. The conveying device according to claim 11, It is characterized in that 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.

13. The conveying device according to claim 12, It is characterized in that 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.

14. The conveying device according to claim 12, It is characterized in that 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.

15. The conveying device according to claim 12, It is characterized in that 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.

16. A conveying system, It is characterized in that The invention comprises an implant and a delivery device as described in any one of claims 1 to 15, wherein the delivery device is used to deliver the implant to a predetermined position and to control the implant to clamp a target tissue.

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