An annuloplasty manipulator and annuloplasty system

Abstract

The application provides a valve annuloplasty manipulator and a valve annuloplasty system. The valve annuloplasty manipulator comprises at least three anchors, a centralized control unit and a plurality of independent control units. The centralized control unit comprises a driving gear and a plurality of driven gears in transmission connection with the driving gear. Each independent control unit comprises a movable rod and an elastic member abutting to the distal end of the movable rod. The distal end of at least three movable rods is connected with an anchor. Each driven gear is in transmission connection with each elastic member. The driving gear drives each driven gear, and each driven gear drives each movable rod and the corresponding anchor to move towards the distal end through each elastic member. When the distal end of one of the anchors is blocked, the corresponding elastic member is axially compressed, and the corresponding movable rod and anchor are independently stopped. The valve annuloplasty manipulator can make the distal end of each anchor abut to different positions of the concave or convex of the valve annulus. After all the anchors are anchored into the valve annulus, the valve annuloplasty manipulator can completely fit the real 3D structure of the valve annulus.

Description

Technical Field

[0001] This application belongs to the field of medical device technology, and specifically relates to a valve annulus repair manipulator and a valve annulus repair system. Background Technology

[0002] Heart valves (including mitral and tricuspid valves) consist of annulus, leaflets, chordae tendineae, and papillary muscles. For valves to function properly, the annulus must be of appropriate size, the leaflets must be structurally intact, and the papillary muscles must contract to pull the chordae tendineae to close the valve. Annular dilation is one of the most common causes of valvular heart disease. It can cause the leaflets to separate during ventricular systole, creating gaps that prevent effective closure or engagement, leading to regurgitation and reduced cardiac output.

[0003] Annuloplasty, a procedure performed to repair mitral or tricuspid valve dilation, is an important surgical technique. Its principle is to address the leaflet insufficiency caused by annular dilation by constricting the annulus, reducing the orifice area of ​​the mitral or tricuspid valve so that the leaflets can adhere to each other during ventricular systole, thereby reducing or eliminating regurgitation. While surgical repair of the annulus is very effective, it has disadvantages such as significant trauma, high risk, and slow patient recovery. In recent years, minimally invasive catheter-based annuloplasty has emerged, which uses appropriate annulus repair devices to annulate the mitral or tricuspid valve while the heart is not beating.

[0004] Existing technology discloses an interventional annulus formation manipulator that delivers an expandable annular nickel-titanium scaffold to the annulus. Several helical anchors are embedded in the circumferential edge of the annulus. These helical anchors are then sequentially anchored into the annulus tissue. Finally, the annulus shrinks to achieve annulus shrinkage, allowing for the delivery of multiple anchors at once. While the operation is relatively convenient, it still has significant drawbacks: after the annulus expands and before the anchors are anchored into the annulus, the distal ends of the anchors are essentially flush. However, different parts of the actual annulus surface have concave and convex features. The distal ends of some anchors may contact the annulus, while the distal ends of others do not. Consequently, after performing the same anchoring operation on each anchor, those anchors that initially did not contact the annulus may still not be anchored into the annulus or may have only a small amount of anchoring. Therefore, this annulus formation manipulator cannot ensure that all anchors fit the true 3D structure of the annulus after anchoring, thus affecting the annulus shrinkage effect. Summary of the Invention

[0005] A primary objective of this application is to overcome the deficiencies of the prior art and provide a valve ring forming manipulator, comprising:

[0006] At least three anchors for anchoring into the annular tissue;

[0007] A centralized control unit includes a drive gear and a plurality of driven gears that are drively connected to the drive gear;

[0008] And multiple independent control components, which are arranged one-to-one with the multiple driven gears. Each of the independent control components includes a movable rod and an elastic element that abuts against the far end of the movable rod. At least three of the movable rods are connected to an anchor pin at their far ends.

[0009] Each of the driven gears is connected to each of the elastic elements in a corresponding transmission.

[0010] The driving gear drives each of the driven gears, and each of the driven gears drives each of the movable rods and the corresponding anchors to move toward the distal end through each of the elastic elements; when the distal end of one of the anchors is blocked, the corresponding elastic element is axially compressed, and the corresponding movable rod and the anchor stop moving independently.

[0011] The present invention also discloses a valve ring forming system, including an actuation component, a flexible shrinking ring member, and a valve ring forming manipulator with the above-described structure. Each of the anchors is connected to each of the independent control components through the actuation component, and the flexible shrinking ring member is connected in series with the proximal end of each of the anchors.

[0012] The beneficial effects of the annular forming manipulator and annular forming system of this application are as follows: the drive gear in the rotating centralized control component enables each driven gear to act on each elastic element. Each elastic element always tends to restore its initial length, thereby driving the corresponding movable rods and the anchors connected to each movable rod to move synchronously toward the annular ring. When the distal end of one of the anchors reaches and abuts the annular ring and is blocked, the resistance of the annular ring to the anchor is transmitted to the corresponding movable rod. The movable rod then blocks the restoration of the corresponding elastic element. Both ends of the elastic element are subjected to force and undergo axial compression. Thus, the elastic element uses its own deformation to compensate for the amount of movement that it should have generated by driving the corresponding movable rod. The corresponding movable rod and anchor stop moving independently, while the other anchors that have not reached the annular ring are unaffected and continue to move synchronously toward the annular ring until the distal ends of each anchor abut against different concave or convex positions on the annular ring. On this basis, after all the anchors are anchored into the annular ring, they can completely fit the real 3D structure of the annular ring, forming a three-dimensional annular ring forming space, which significantly improves the ring shrinking effect. Attached Figure Description

[0013] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0014] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, for those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0015] Figure 1 This is an overall view of a valve ring forming system according to an exemplary embodiment.

[0016] Figure 2 This is a schematic diagram of the structure of an execution component in a collapsed state according to an exemplary embodiment.

[0017] Figure 3 This is a schematic diagram of the structure of an execution component in an expanded state according to an exemplary embodiment.

[0018] Figure 4 This is a schematic diagram of the structure of a support member according to an exemplary embodiment.

[0019] Figure 5 This is a schematic cross-sectional view of a catheter according to an exemplary embodiment.

[0020] Figure 6 This is an exploded structural diagram of a valve ring forming manipulator and handle according to an exemplary embodiment.

[0021] Figure 7 This is a longitudinal cross-sectional view of a valve ring forming manipulator and handle according to an exemplary embodiment.

[0022] Figure 8 for Figure 7 A magnified view of part A in the middle.

[0023] Figure 9 for Figure 7 A magnified view of part B in the middle.

[0024] Figure 10 for Figure 8 A magnified view of a section at point C.

[0025] Figure 11 This is a longitudinal cross-sectional view of an independent control unit according to an exemplary embodiment.

[0026] Figure 12 This is an overall view of a stand-alone control unit according to an exemplary embodiment.

[0027] Figure 13 This is an exploded view of a stand-alone control unit according to an exemplary embodiment.

[0028] Figure 14 This is a structural diagram of a tailstock according to an exemplary embodiment.

[0029] Figure 15 This is a structural diagram of a centralized control unit according to an exemplary embodiment.

[0030] Figure 16 This is an assembly diagram of a tailstock, independent control unit, and centralized control unit according to an exemplary embodiment.

[0031] Figure 17 for Figure 16 The exploded diagram.

[0032] Figure 18 This is a longitudinal cross-sectional view of an inner core according to an exemplary embodiment.

[0033] Figure 19 This is a structural diagram of the main control member and support member according to an exemplary embodiment.

[0034] Figure 20 This is a partial structural diagram illustrating the detachment of an anchor bolt from an anchor rod according to an exemplary embodiment.

[0035] Figure 21 This is a partial structural diagram illustrating an anchor pin not detached from the anchor rod according to an exemplary embodiment.

[0036] Figure 22 This is a schematic diagram illustrating a structure in which the anchor pin does not detach from the anchor rod when the support rod is removed, according to an exemplary embodiment.

[0037] Figure 23 This is a structural diagram of the main control component according to another exemplary embodiment.

[0038] Figure 24 This is a structural diagram of the main control component according to another exemplary embodiment.

[0039] Figure 25 This is a schematic diagram of the valve annulus repair system reaching the left atrial valve annulus through a sheath, unfolding the flexible annulus component, and anchoring it to the valve annulus tissue using anchor pins.

[0040] Figure 26 This is a schematic diagram of the annulus repair system and the sheath after it has been removed from the human body.

[0041] The reference numerals in the attached figures are explained as follows:

[0042] Sheath 10, End Cap 100, Outer Shell 200, Inner Core 300, Anti-rotation Rib 310, Through Hole 330, Intermediate Hole 350, Docking Hole 360, Tail Seat 400, Limiting Platform 410, Support Groove 420, Flat Plane 421, Extension Rod 430, Bearing Component 440, Main Control Component 500, Adjustment Knob 510, Moving Component 810, Positioning Component 820, Elastic Body 830, Movable Component 910, Positioning Block 920, Positioning Button 930, Centralized Control Component 600, Drive Gear 610, Driven Gear 620, Bushing 621, Radial Limiting Rib 611, Independent Control Component 700, Rotating Seat 7 10. Handheld part 711, movable rod 720, stop block 722, sliding part 730, flat part 732, elastic part 740, rotating rod 750, control cover 760, control part 761, clamping part 770, handle 1000, guide tube 2000, circumferential side cavity 2100, central cavity 2200, actuating component 3000, support part 3100, main base 3110, support rod 3120, main push rod 3140, movable base 3150, connecting rod 3170, actuating component 3200, anchor pin 3210, anchoring rod 3220, release rod 3230, flexible shrink ring part 3300. Detailed Implementation

[0043] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0044] It should be understood that the orientations or positional relationships indicated by terms such as "front", "rear", "up", "down", "left", "right", "longitudinal", "horizontal", "vertical", "horizontal", "top", "bottom", "inner", "outer", "head", and "tail" are based on the orientations or positional relationships shown in the accompanying drawings, and are constructed and operated in a specific orientation. They are only for the purpose of describing this technical solution and do not indicate that the device or component referred to must have a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0045] It should also be noted that, unless otherwise explicitly specified and limited, terms such as "installation," "connection," "linking," "fixing," and "setting" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. When an component is referred to as being "on" or "below" another component, the component can be located "directly" or "indirectly" on the other component, or there may be one or more intermediary components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0046] In the description of this invention, it should still be noted that the proximal end refers to the end of the instrument or component that is closer to the operator, and the distal end refers to the end of the instrument or component that is farther away from the operator; the axial direction refers to the direction parallel to the line connecting the center of the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0047] To overcome the defect in existing technologies where multiple anchors are flush at their distal ends before anchoring into the valve annulus, resulting in a failure to fit the 3D structure of the valve annulus after anchoring, such as... Figure 1 , Figures 6 to 8 , Figures 10 to 13 and Figures 15 to 17 As shown, this invention discloses a valve annulus forming manipulator, including multiple anchors 3210 for anchoring into the valve annulus tissue, a centralized control element 600, and multiple independent control elements 700. Figures 15 to 17 As shown, the centralized control unit 600 includes a drive gear 610 and a plurality of driven gears 620 that are pulverizedly connected to the drive gear 610. For example... Figure 10 , Figures 11 to 13 , Figure 16 , Figure 17 and Figure 22As shown, the independent control components 700 and the driven gears 620 are arranged in a one-to-one correspondence. Each independent control component 700 includes a movable rod 720 and an elastic element 740 sleeved and abutting against the far end of the movable rod 720. The far end of each movable rod 720 is connected to an anchor 3210. Each driven gear 620 is connected to each elastic element 740. The rotation of the drive gear 610 drives each driven gear 620 to rotate synchronously. Each driven gear 620 then drives each movable rod 720 and anchor pin 3210 to move along the axial direction of the movable rod 720 toward the distal end, i.e., toward the petal ring, through each elastic element 740. When the distal end of one of the anchor pins 3210 abuts against the petal ring, the corresponding elastic element 740 is obstructed and undergoes axial compression. The corresponding movable rod 720 and anchor pin 3210 then stop moving independently. At the same time, the other movable rods 720 and anchor pins 3210 are not affected by this and continue to approach the petal ring until the distal ends of each anchor pin 3210 abut against different concave or convex positions on the petal ring.

[0048] In the above embodiment, the number of movable rods 720 is equal to the number of anchors 3210, so that the distal end of each movable rod 720 is connected to an anchor 3210. It is understood that in other embodiments, the number of movable rods 720 may be greater than the number of anchors 3210, but the number of anchors 3210 should be at least three to accommodate the need for the tightening ring. Accordingly, at least three movable rods 720 are connected to an anchor 3210 at their distal ends, while the distal ends of other movable rods 720 are not connected to anchors 3210.

[0049] In the technical solution of this invention, the drive gear 610 in the rotary centralized control member 600 enables each driven gear 620 to act on each elastic member 740. Each elastic member 740 always tends to restore its initial length, thereby driving the corresponding movable rod 720 and the anchor 3210 connected to each movable rod 720 to move synchronously towards the petal ring, i.e., towards the distal end. When the distal end of one of the anchors 3210 reaches and abuts against the petal ring and is blocked, the resistance of the petal ring to the anchor 3210 is transmitted to the corresponding movable rod 720. The movable rod 720 then blocks the restoration of the corresponding elastic member 740, and both ends of the elastic member 740 are subjected to force and axial force is generated. Compression causes the elastic element 740 to compensate for the movement it should have caused by driving the corresponding movable rod 720. The corresponding movable rod 740 and anchor pin 3210 stop moving independently, while other anchor pins 3210 that haven't reached the petal ring are unaffected and continue to move synchronously towards the petal ring under the transmission action of the centralized control element 600 on the corresponding elastic element 740, until the distal ends of each anchor pin 3210 abut against different recessed or protruding positions on the petal ring. Based on this, after all anchor pins 3210 are anchored into the petal ring, they can perfectly fit the true 3D structure of the petal ring, forming a three-dimensional petal ring forming space, significantly improving the ring-shrinking effect. Furthermore, the distal ends of each anchor pin 3210 abut against the petal ring can be achieved simply by rotating the drive gear 610 of the centralized control element 600, making operation convenient.

[0050] like Figures 10 to 13As shown, in a preferred embodiment, each independent control element 700 further includes a sliding element 730 slidably sleeved on the movable rod 720. Sliding sleeved means that the sliding element 730 is sleeved on the movable rod 720, and the sliding element 730 can slide axially relative to the movable rod 720, but cannot rotate relative to it. Each driven gear 620 is correspondingly connected to each sliding element 730, and the rotation of each driven gear 620 correspondingly drives each sliding element 730 to slide on the corresponding movable rod 720. The proximal end of the elastic element 740 abuts against the distal end of the sliding element 730, and the distal end of the elastic element 740 abuts against the distal end of the movable rod 720. In this embodiment, the sliding member 730 converts the rotation of the driven gear 620 into its own axial movement, thereby applying pressure to the elastic member 740. The proximal end of the elastic member 740 is compressed by the sliding member 730, but when the corresponding anchor 3210 does not abut against the petal ring, the distal end of the elastic member 740 is essentially a free end. The elastic member 740 always tends to restore its initial length, thereby driving the corresponding movable rod 720 and anchor 3210 to move axially toward the petal ring. The structure is compact and ingenious, and the operation is simple. Specifically, a circumferentially protruding retaining ring or stop 722 can be provided at the distal end of the movable rod 720 for the distal end of the elastic member 740 to abut against. The retaining ring or stop 722 can be integrally formed with the movable rod 720, or it can be fixed or snapped in other ways. In addition, a positioning ring 780 is also provided at the proximal end of the movable rod 720, which can limit the extreme position of the sliding member 730 relative to the proximal end of the movable rod 720, preventing the sliding member 730 from falling off the movable rod 720.

[0051] In this embodiment, the elastic element 740 is preferably a helical spring. It is understood that in other embodiments, the elastic element 740 can also be other structural forms, such as a spring sheet, an elastic coil, etc., as long as the elastic element has the property of springing open under pressure.

[0052] like Figures 14 to 17 As shown, further, in the above embodiment, a sliding member 730 is correspondingly inserted into a support groove 420, and the support groove 420 has an opening along the axial direction of the driven gear 620. The sliding member 730 has a threaded portion 731 and a flat portion 732 adapted to the support groove 420, with the threaded portion 731 exposed outside the opening of the support groove 420. In this embodiment, the sliding member 730 is slidably sleeved on the movable rod 720. To improve the stability of the transmission, a flat surface 421 that fits with the flat portion 732 is provided in the support groove 420. The fit between the flat surfaces provides a guiding effect for the axial displacement of the sliding member 730. The opening in the support groove 420 not only allows for sliding engagement with the sliding member 730 but also allows the sliding member 730 to engage with other components, resulting in a compact structure and easy assembly.

[0053] Furthermore, combining Figures 11 to 13 and Figure 22In the above embodiment, the driven gear 620 is sleeved on the outer periphery of the support groove 420 and screwed to the threaded portion 731. In this embodiment, the driven gear 620 has an internal thread, forming a threaded connection with the threaded portion 731 of the sliding member 730 that protrudes from the support groove 420. The driven gear 620 is driven by the drive gear 610 to rotate, and its rotation is converted into the sliding of the sliding member 730 on the movable rod 720 through threaded transmission. Then, the movable rod 720 is driven to move axially through the elastic member 740, which is ultimately manifested as the displacement of the anchor 3210. Specifically, a bushing 621 is fixed inside the driven gear 620. The inner wall of the bushing 621 has an internal thread, and the axial extension length of the bushing 621 can be set to match or slightly exceed the stroke of the sliding member 730.

[0054] like Figures 11 to 13 and Figure 22 As shown, in a preferred embodiment, the independent control unit 700 further includes a rotating seat 710 and a rotating rod 750 fixed to the distal end of the rotating seat 710. The rotating rod 750 is linked to the anchor 3210 and threadedly connected to the movable rod 720. When the anchor 3210 abuts against the annulus, rotating the rotating seat 710 can drive the rotating rod 750 and the anchor 3210 to rotate relative to the movable rod 720 while moving along the axial direction of the rotating rod 720, so that the anchor 3210 is anchored into the annulus tissue. That is, each independent control unit 700 is also used to control the anchoring action of each anchor 3210. The outer periphery of the rotating rod 750 is threadedly connected to the inner wall of the movable rod 720, or the inner wall of the rotating rod 750 is threadedly connected to the outer periphery of the movable rod 720.

[0055] like Figures 1 to 5 , Figure 17 , Figure 19 and Figures 20 to 22 As shown, the present invention also provides a valve annulus repair system, including an actuation component 3000, a flexible constricting ring member 3300, and a valve annulus repair manipulator with the above-described structure. Multiple anchors 3210 correspond one-to-one with multiple independent control members 700 in the valve annulus repair manipulator. Each anchor 3210 is connected to each independent control member 700 via the actuation component 3000, and the proximal ends of each anchor 3210 are connected in series via the flexible constricting ring member 3300. Since each anchor 3210 needs to be inserted into the heart via a catheter 2000 during actual operation, while the valve annulus repair manipulator needs to be operated externally, the actuation component 3000 is designed to meet the needs of this valve annulus repair system's intervention in the human body.

[0056] Specifically, the flexible shrinking ring 3300 is preferably made of biocompatible flexible thread, flexible rope, or flexible strip, and its shape can be either closed or open. As mentioned above, after each anchor 3210 is anchored into the petal annulus, it can completely fit the actual 3D structure of the petal annulus. The flexible shrinking ring 3300 is inserted on the proximal end of each anchor 3210, and naturally forms a three-dimensional petal annulus forming space with the proximal end of each anchor 3210. If the flexible shrinking ring 3300 is a closed loop, it should be elastic. After all the anchors 3210 are separated from the actuator 3000, the flexible shrinking ring 3300 can shrink by its own elastic contraction. If the flexible shrinking ring 3300 is an open loop, then after all the anchors 3210 are separated from the actuator 3000, the two ends of the flexible shrinking ring 3300 can be pulled and locked to close it, thereby achieving shrinking.

[0057] like Figures 20 to 22 As shown, in the above embodiment, the execution component 3000 includes a plurality of execution elements 3200, and a plurality of anchors 3210 correspond one-to-one with the plurality of execution elements 3200. Specifically, each execution element 3200 includes an anchoring rod 3220 and a release rod 3230.

[0058] Specifically, in combination Figure 7 and Figure 8 The proximal end of the anchor rod 3220 moves through the corresponding movable rod 720 and is fixed to the corresponding rotating rod 750. The distal end of the anchor rod 3220 is movably inserted into the proximal end of the corresponding anchor pin 3210 along the axial direction of the anchor rod 3220. Specifically, the proximal end of the anchor pin 3210 is provided with an axially extending protrusion 3211, and the distal end of the anchor rod 3220 is provided with an axially extending groove 3221. When the protrusion 3211 is inserted into the groove 3221, the anchor rod 3220 can drive the anchor pin 3210 to rotate and move axially to the distal end. The anchor rod 3220 can retract relative to the anchor pin 3210, and the groove 3221 will disengage from the protrusion 3211.

[0059] The release lever 3230 is movably inserted into the corresponding anchoring lever 3220 and the independent control member 700, and the distal end of the release lever 3230 is detachably connected to the proximal end of the anchor pin 3210. Specifically, in this embodiment, the proximal end of the anchor pin 3210 and the distal end of the release lever 3230 are respectively provided with complementary snap-fit ​​structures, such as Z-shaped, S-shaped or wavy shapes. Because the shapes of the snap-fit ​​structures are complementary and adaptable, when the distal end of the anchor rod 3220 is in an inserted state with the proximal end of the corresponding anchor 3210, the snap-fit ​​structure is wrapped by the anchor rod 3220 and cannot be separated, and the proximal end of the anchor 3210 is connected with the distal end of the release rod 3230; when the distal end of the anchor rod 3220 is disengaged from the proximal end of the corresponding anchor 3210 and they separate, the snap-fit ​​structure loses the wrapping of the anchor rod 3220, and pulling the anchor rod 3220 towards the distal end can make the snap-fit ​​structure overcome the shape obstacle and separate.

[0060] like Figure 8 , Figure 11 and Figure 13 As shown, further, in the above embodiment, the proximal end of the independent control member 700 is also provided with a clamping member 770 and a control cover 760. The proximal end of the release lever 3230 passes through the movable lever 720 and the rotating lever 750 in the independent control member 700 and is placed inside the clamping member 770. The control cover 760 is provided with a control part 761 adapted to the clamping member 770, and the control cover 760 is fastened or screwed onto the proximal end of the rotating seat 710. Specifically, the proximal end of the clamping member 770 may have a frustum shape and at least one radial through-slit. The control part 761 is conical. When the control cover 760 is fastened or tightened, the control part 761 continuously compresses the clamping member 770, reducing the gap and clamping the release lever 3230. When the control cover 760 is removed or loosened, the gap increases, thereby releasing the clamping of the release lever 3230.

[0061] like Figure 7 , Figure 8 , Figure 11 , Figure 13 , Figures 20 to 22As shown, in this embodiment, before the anchor 3210 is anchored into the annulus, the distal end of the anchoring rod 3220 is axially inserted into the proximal end of the corresponding anchor 3210. The snap-fit ​​structure between the proximal end of the anchor 3210 and the distal end of the release rod 3230 is surrounded by the anchoring rod 3220, and the tightening cap 760 is tightened so that the clamping member 770 clamps the release rod. That is, the anchoring rod 3220, the release rod 3230 and the anchor 3210 are connected into a whole. The anchoring rod 3220 is fixedly connected to the rotating rod 750, and the rotating rod 750 is screwed to the movable rod 720. The rotating rod 750 and the movable rod 720 are relatively stationary. The rotating drive gear 610 will cause this whole to move toward the annulus. After the distal ends of each anchor 3210 have abutted against different positions of the concave or convex on the valve annulus, the rotation of the drive gear 610 is stopped. Each rotating seat 710 rotates the rotating rod 750 individually or simultaneously. The rotating rod 750 rotates and moves axially relative to the movable rod 720, thereby anchoring the anchor into the valve annulus tissue. Since the distal ends of each anchor 3210 have abutted against different positions of the concave or convex on the valve annulus, performing the same anchoring operation or rotating the same number of turns on each anchor 3210 can ensure that the anchoring depth of each anchor 3210 is consistent and sufficient to anchor it to the valve annulus. After each anchor 3210 completes its anchoring action, loosen or remove the control cover 760. The release rod 3230 disengages from the clamping member 770. At this point, the entire system can be pulled back proximally. The distal end of the anchor rod 3220 disengages from the proximal end of the corresponding anchor 3210. The distal end of the release rod 3230 and the proximal end of the anchor 3210 are initially subjected to the tension of the annular tissue and are still wrapped by the anchor rod 3220, so the snap-fit ​​connection remains stationary. The components other than the release rod 3230 move backward relative to the release rod 3230. After the anchor rod 3220 is pulled back to expose the snap-fit ​​structure, pulling the release rod 3230 back proximally will separate the release rod 3230 from the anchor 3210. Finally, the anchor pins 3210 anchored into the annulus tissue are brought closer to each other by the action of the flexible annulus shrinking member 3300, thereby reducing the size of the annulus orifice and realizing annulus shrinkage. Moreover, since each anchor pin 3210 can completely fit the real 3D structure of the annulus after being anchored into the annulus, a three-dimensional annulus forming space can be formed, and the annulus shrinkage effect is significantly improved.

[0062] like Figures 1 to 4 and Figures 19 to 21As shown, further in the above embodiment, the execution component 3000 also includes a support member 3100. The support member 3100 includes a main base 3110, a main push rod 3140, a movable base 3150, and a plurality of support rods 3120. The plurality of support rods 3120 correspond one-to-one with the plurality of execution components 3200, and the anchoring rod 3220 of each execution component 3200 slides through the corresponding support rod 3120. The proximal end of each support rod 3120 is rotatably connected to the main base 3110. The movable base 3150 is provided with a plurality of connecting rods 3170 along its outer periphery, and the plurality of connecting rods 3170 correspond one-to-one with the plurality of support rods 3120. The two ends of each connecting rod 3170 are rotatably connected to the movable base 3150 and the corresponding support rod 3120, respectively. The main push rod 3140 moves through the main base 3110, and the distal end of the main push rod 3140 is fixedly connected to the movable base 3150.

[0063] The movable base 3150, main push rod 3140, each connecting rod 3170, each support rod 3120 and the main base 3110 constitute a linkage mechanism. When the main push rod 3140 moves axially, each support rod 3120 can rotate with the main base 3110 as a node and relatively converge or diverge, similar to the closing or opening of an umbrella. With the support rods 3120 relatively converged, the actuator 3000, each anchor 3210, and the flexible shrinking ring 3300 are inserted into the heart, with each anchor 3210 close to the valve annulus tissue. Subsequently, the divergence of each support rod 3120 can be controlled by axial movement of the main push rod 3140, so that each anchor 3210 located at the distal end of each support rod 3120 can adapt to valve annulus of different sizes. Once the adjusting rod 3140 remains stationary, the degree of expansion of the support member 3100 is maintained. With the inherent characteristics of the linkage structure, the support member 3100 can provide reliable and sufficient support force for the anchoring process of each anchor 3210, so that each anchor 3210 can be accurately anchored into the predetermined position.

[0064] like Figure 1 , Figures 6 to 10 As shown, or further, in the above embodiment, the valve ring forming system also includes a handle 1000, which includes an end cap 100, a housing 200, and a tailstock 400 connected in sequence. A centralized control unit 600 and multiple independent control units 700 are all mounted on the tailstock 400. An inner core 300 is provided inside the housing 200, and the inner core 300 has multiple channels through which the main push rod 3140 and multiple actuators 3200 pass, and the inner core 300 is connected to the tailstock 400. The main push rod 3140 and multiple actuators 3200 all protrude from the end cap 100. In this embodiment, the handle 1000 provides a mounting carrier for the centralized control unit 600 and multiple independent control units 700, facilitating gripping and operation by the operator.

[0065] like Figures 6 to 8 , Figure 17 and Figure 19 As shown, further in the above embodiment, the valve ring forming system also includes a main control member 500. The main control member 500 is connected to the proximal end of the main push rod 3140 and is used to control the axial movement or stationary position of the main push rod 3140 to adjust or maintain the degree of opening of each support rod 3120.

[0066] like Figure 19 As shown, further, in the above embodiment, the main control component includes an adjustment knob 510. The adjustment knob 510 is provided with a thread that is screwed into the tailstock 400 on the handle 1000 described later. Rotating the adjustment knob 510 can drive the main push rod 3140 to move axially, thereby controlling and adjusting the degree of opening of each support rod 3120 to adapt to different sizes of petal rings. When the adjustment knob 510 is stopped, the main push rod 3140 remains stationary due to the self-locking effect of the thread, and the degree of opening of each support rod 3120 is maintained.

[0067] like Figure 23 As shown, the main control component 500 can also be configured in another embodiment, including a moving component 810 and a positioning component 820. The moving component 810 is fixed to the proximal end of the main push rod 3140; the positioning component 820 is engaged with the moving component 810, and the moving component 810 can be released from engagement with the positioning component 820 by being pulled or compressed. Figure 23 The diagram illustrates a structure where the movable element 810 is released from engagement with the positioning element 820 under pressure. Specifically, the movable element 810 passes through the proximal end of the handle, and the positioning element 820 is fixedly connected to or integrated with the proximal end of the handle 1000. An elastic body 830 is pre-installed within the mounting space provided between the movable element 810 and the proximal end of the handle. The movable element 810 has teeth, and the positioning element 820 also has teeth of the same shape. The movable element 810 and the positioning element 820 are engaged by their teeth, and the movable element 810 is held in place by the elastic body 830. This achieves axial locking of the movable element 810 relative to the proximal end of the handle. When the movable element 810 is pressed down, the toothed engagement between the movable element 810 and the positioning element 820 is released. This can be achieved by pushing or pulling the movable rod to move the main push rod 3140. When the movable element 810 is no longer pressed down, the elastic body 830 rebounds and holds the movable element 810, causing the teeth to engage again, thus locking the position of the movable element 810.

[0068] like Figure 24As shown, the main control component 500 can also be configured in another embodiment, including a movable component 910, a positioning block 920, and a positioning button 930. The movable component 910 has teeth or other shapes adapted to the positioning button 930 for positioning. The positioning block 920 is used to mount the positioning button 930. A spring is provided on the outer periphery of the positioning button 930 to maintain a normal locked position of the positioning button 930 and the positioning block 920 on the movable component 910. When the movable component 910 is pushed to move, under dynamic conditions, the positioning button 930 disengages from one tooth under the push of the toothed structure. Under the action of the spring, it bounces as the teeth change sequentially until the pushing of the movable component 910 stops. Then, under the action of the spring, the positioning button 930 re-enters another tooth, thus re-locking the movable component 910.

[0069] In addition, such as Figure 1 and Figure 5 As shown, combined with Figure 4 A conduit 2000 can also be provided. The conduit 2000 is connected between the main base 3110 and the handle 1000. The conduit 2000 has multiple cavities, of which the central cavity 2200 is for the main push rod 3140 to pass through, and multiple circumferential side cavities 2100 are for multiple actuators 3200 to pass through.

[0070] Specifically, such as Figures 7 to 9 and Figure 18 As shown, the inner core 300 has a plurality of through holes 330 evenly distributed along the circumference of the inner core 300, the same number as the actuators 3200, as well as a central hole 350 located in its middle and a docking hole 360 ​​connecting the central hole 350 and located at its distal end. The anchoring rod 3220 and its internal release rod 3230 pass through the corresponding circumferential side cavity 2100 of the guide tube 2000, and then pass through the corresponding through hole 330 to connect to the corresponding independent control member 700. Specifically, as mentioned above, the anchoring rod 3220 is fixed directly to the rotating rod 750, and the release rod 3230 is connected to the clamping member 770. The main push rod 3140 passes through the central cavity 2200 of the guide tube 2000, and then passes through the docking hole 360 ​​and the central hole 350 to connect to the main control member 500.

[0071] Furthermore, in the above embodiment, the inner core 300 is generally conical in shape, with its radial dimension gradually increasing from the distal end to the proximal end. The conical structure causes the through holes 330 to gradually diverge from the distal end to the proximal end, so that the proximal end of each through hole 330 is far away from the central axis. The anchoring rod 3220 and the release rod 3230 passing through them are further away from each other as the through holes 330 diverge, so that the multiple independent control components 700 and the centralized control component 600 have relatively sufficient installation space.

[0072] like Figure 16 and Figure 17As shown, or further, in the above embodiment, the tailstock 400 includes an extension rod 430 and a plurality of support members 440, the same number as the number of independent control members 700. The aforementioned opening slots 420 are correspondingly formed on each of the support members 440, and each independent control member 700 is correspondingly placed on each support member 440. The extension rod 430 is located at the central axis formed by the support members 440, and is generally cylindrical in shape, extending axially towards its proximal end. A drive gear 610 is sleeved and mounted on the extension rod 430 and meshes with the plurality of driven gears 620. The proximal end of the extension rod 430 is internally threaded, and the adjustment knob 510 of the main control member 500 is threadedly connected to the proximal end of the extension rod 430.

[0073] Specifically, such as Figure 15 , Figure 17 and Figure 18 As shown, the drive gear 610 is provided with a radial limiting rib 611, which engages with a corresponding annular groove on the outer casing 200, ensuring that the drive gear 610 can only rotate around the axial direction of the tailstock 400 and cannot be separated axially. A limiting ring 410 can also be provided at the distal end of the tailstock 400, which is inserted into a matching annular groove at the proximal end of the inner core 300 to maintain coaxiality between the inner core 300 and the tailstock 400, ensuring smooth movement of the actuator 3200 within the inner core 300.

[0074] like Figure 6 As shown, or further, in the above embodiment, the outer periphery of the inner core 300 is provided with an anti-rotation rib 310 extending axially. The anti-rotation rib 310 cooperates with the groove adapted in the outer shell 200 to prevent the inner core 300 from rotating and causing misalignment between each through hole 330 and each loading component on the tailstock 400.

[0075] The following example of repairing the mitral valve annulus illustrates the general usage process of the annulus reshaping system of the present invention:

[0076] First, such as Figure 25 As shown, combined with Figure 1 and Figure 2 The catheter 2000 is delivered to the left atrium through the interventional channel (femoral vein-inferior vena cava-right atrium-atrial septum-left atrium) established by the delivery sheath 10, so that the support 3100, anchor 3210 and flexible shrinking ring 3300 are close to the mitral valve annulus. During delivery, the support 3100 remains in a shrinking state.

[0077] Next, combined Figure 3 , Figure 4 , Figure 8 and Figure 19First, by manipulating the main control component 500 on the handle 1000, the main push rod 3140 is moved axially to the distal end, causing the support component 3100 to open to a size suitable for the annulus. Then, by manipulating the drive gear 610 of the centralized control component 600 on the handle 1000, multiple anchors 3210 extend axially to the distal end relative to each support rod 3120 of the support component 3100, so as to approach the annulus tissue, until the distal ends of each anchor 3210 abut against different concave or convex positions on the annulus. Then, by manipulating the individual control components on the handle 1000, each anchor 3210 is driven to anchor into the annulus tissue.

[0078] Then, combine Figure 8 , Figure 20 ,and Figure 22 Loosen or remove the control cap 760, move the entire system proximally to the anchor 3210, and then move each release lever 3230 proximally to disengage it from the corresponding anchor 3210.

[0079] Finally, as Figure 26 As shown, only the anchor pins 3210 anchored into the petal ring and the flexible shrinking ring members 3300 connected in series on each anchor pin 3210 are left. By utilizing the self-shrinkage of the flexible shrinking ring members 3300 or by tightening and locking the flexible shrinking ring members 3300, each anchor pin 3210 is brought closer to each other by the action of the flexible shrinking ring members 3300, thereby reducing the petal opening size and realizing the shrinking ring.

[0080] It is understood that the annulus repair system of the present invention can also be applied to repair the tricuspid valve annulus, and the process is similar, so it will not be described in detail here.

[0081] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve ring forming manipulator, characterized in that, include: At least three anchors for anchoring into the annular tissue; A centralized control unit includes a drive gear and a plurality of driven gears that are drively connected to the drive gear; And multiple independent control components, which are arranged one-to-one with the multiple driven gears. Each of the independent control components includes a movable rod and an elastic element that abuts against the far end of the movable rod. At least three of the movable rods are connected to an anchor pin at their far ends. Each of the driven gears is connected to each of the elastic elements in a corresponding transmission. The driving gear drives each of the driven gears, and each of the driven gears drives each of the movable rods and the corresponding anchors to move toward the distal end through each of the elastic elements; when the distal end of one of the anchors is blocked, the corresponding elastic element is axially compressed, and the corresponding movable rod and the anchor stop moving independently.

2. The valve ring forming manipulator according to claim 1, characterized in that, The independent control component further includes a sliding member slidably sleeved on the movable rod; each of the driven gears is correspondingly connected to the sliding member; the proximal end of the elastic member abuts against the distal end of the sliding member, and the distal end of the elastic member abuts against the distal end of the movable rod.

3. The valve ring forming manipulator according to claim 2, characterized in that, Each of the sliding members is correspondingly inserted into each of the support grooves; the support grooves have openings along the axial direction of the driven gear, and the sliding members have threaded portions and flat portions adapted to the support grooves, with the threaded portions exposed outside the openings of the support grooves.

4. The valve ring forming manipulator according to claim 3, characterized in that, The driven gear is rotatably sleeved on the outer periphery of the support groove and screwed into the threaded part.

5. The valve ring forming manipulator according to claim 1, characterized in that, The independent control unit also includes a rotating seat and a rotating rod fixed to the far end of the rotating seat. The rotating rod is linked with the corresponding anchor and screwed to the movable rod. The rotating seat rotates to drive the rotating rod and the anchor to rotate relative to the movable rod while moving along the axial direction of the rotating rod.

6. A valve ring forming system, characterized in that, The device includes an actuation component, a flexible retractable ring, and a petiole forming manipulator as described in any one of claims 1-5, wherein each of the anchors is connected to each of the individual control components via the actuation component, and the flexible retractable ring is connected in series with the proximal ends of each of the anchors.

7. The valve ring forming system according to claim 6, characterized in that, The execution component includes multiple execution elements, and the multiple independent control elements correspond one-to-one with the multiple execution elements; Each of the aforementioned actuators includes an anchor rod and a release rod; the proximal end of the anchor rod is fixed to the corresponding independent control component, and the distal end of the anchor rod is movably inserted into the proximal end of the corresponding anchor along the axial direction of the anchor rod; the release rod is movably inserted into the anchor rod and the independent control component, and the distal end of the release rod is detachably connected to the proximal end of the corresponding anchor.

8. The valve ring forming system according to claim 7, characterized in that, The proximal end of the independent control unit is also provided with: A clamping element, wherein the proximal end of the release lever passes through the corresponding independent control element and is placed within the clamping element; And a control cover, the inside of which is provided with a control part adapted to the clamping member, the control cover being fastened or screwed to the proximal end of the corresponding independent control member.

9. The valve ring forming system according to claim 7, characterized in that, The near end of the anchor and the far end of the corresponding release rod are respectively provided with complementary snap-fit ​​structures.

10. The valve ring forming system according to claim 7, characterized in that, The execution component further includes a support member, the support member comprising: Multiple support rods correspond one-to-one with the multiple actuators, and the anchor rod of each actuator slides through the corresponding support rod; The main base, with the proximal ends of each of the support rods rotatably connected to the main base; A movable base and a plurality of connecting rods arranged along the outer periphery of the movable base, wherein each connecting rod corresponds one-to-one with a plurality of support rods, and both ends of each connecting rod are rotatably connected to the movable base and the corresponding support rod, respectively; and, A main push rod, which movably passes through the main base, and the distal end of the main push rod is fixedly connected to the movable base; The movable base, the main push rod, each of the connecting rods, each of the support rods, and the main base constitute a linkage mechanism.

11. The valve ring forming system according to claim 10, characterized in that, It also includes a handle, which includes an end cap, a housing, and a tailstock connected in sequence. The housing has an inner core component. The centralized control component and the multiple independent control components are all mounted on the tailstock. The inner core component has multiple channels for the main push rod and the multiple actuators to pass through. The inner core component is connected to the tailstock.

12. The valve ring forming system according to claim 11, characterized in that, It also includes a main control unit, which is connected to the proximal end of the main push rod and is used to control the main push rod to move or remain stationary along its axial direction.

13. The valve ring forming system according to claim 11, characterized in that, The radial dimension of the inner core gradually increases from the distal end to the proximal end, and the plurality of channels within the inner core gradually diverge from the distal end to the proximal end.

14. The valve ring forming system according to claim 11, characterized in that, The tailstock includes: A plurality of carrier members corresponding one-to-one with the plurality of independent control components, each of the independent control components being mounted on its respective carrier member, and each of the driven gears being rotatably sleeved on its respective carrier member; and... An extension rod is located at the central axis formed by the plurality of bearing members, and the drive gear is rotatably sleeved on the extension rod and meshes with the plurality of driven gears.

15. The valve ring forming system according to claim 11, characterized in that, It also includes a conduit, which is connected between the main base and the handle, and the conduit has multiple compartments through which the main push rod and the plurality of actuators pass.

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