Valve clip conveying device convenient to operate

Abstract

The invention provides a valve clip conveying device which is used for conveying and controlling a valve clip. The valve clamp comprises at least two capturing elements, and the valve clamp conveying device comprises a sheath tube and a handle. The handle comprises a shell and at least two control units, the at least two capturing control lines movably penetrate through the sheath tube, and the two ends of the capturing control lines are connected to the corresponding capturing elements and the control units respectively. Each control unit is provided with a connecting part, and one control unit is rotated to force the corresponding connecting part to be switched between mutual connection and mutual disconnection relative to at least the other connecting part. When the connecting parts are connected with each other, the control unit is axially moved so as to simultaneously control the capturing element to be retracted or released through the capturing control line; and when the connecting parts are separated from each other, each control unit is axially moved to independently control the corresponding capturing element to be retracted or released. According to the valve clip conveying device, the capturing elements can be controlled at the same time or independently, and the operation efficiency is improved.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a valve clip delivery device that is easy to operate. Background Art

[0002] The mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart. A normal and healthy mitral valve can control the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets, called the anterior leaflet and the posterior leaflet. Under normal circumstances, when the left ventricle of the heart contracts, the edges of the anterior leaflet and the posterior leaflet are completely aligned to prevent blood from flowing from the left ventricle to the left atrium. When the leaflets, chordae tendineae, and valve ring of the mitral valve are diseased, such as partial rupture of the chordae tendineae, and the anterior and posterior leaflets of the mitral valve are poorly aligned, then when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, causing blood to flow back from the left ventricle to the left atrium, thereby causing a series of pathological and physiological changes, known as "mitral valve regurgitation."

[0003] The edge-to-edge repair of the mitral valve is an effective method for treating mitral regurgitation. Specifically, the edges of the anterior and posterior leaflets of the mitral valve that cannot be normally aligned are fixed together by suturing or clamping, thereby reducing the leaflet gap and forming a double-hole structure of the mitral valve orifice to reduce the total area of ​​the mitral valve orifice and reduce or eliminate regurgitation. Traditional mitral valve edge-to-edge repair is performed under direct vision, usually requiring thoracotomy and establishment of extracorporeal blood circulation, so the risk is relatively high. With the advancement of technology, various minimally invasive and interventional surgeries have been developed. This type of surgery only requires a small operating window to be cut in the patient's body, and then the valve clip is delivered to the diseased mitral valve using a valve clip delivery device. The valve clip clamps part of the edges of the two leaflets together, so that the mitral valve orifice forms a double-hole structure, thereby reducing regurgitation.

[0004] An existing valve clip includes a clamping element and a capturing element. The valve clip delivery device controls the free end of the capturing element to move away from or close to the free end of the clamping element by tightening or loosening the capturing control line connected to the capturing element, thereby capturing or holding the leaflet between the capturing element and the clamping element. After that, the valve clip delivery device drives the clamping element to close relatively to clamp and fix part of the valve edges of the two leaflets together. Before the valve clip delivery device is released from the valve clip, the capturing control line needs to be withdrawn. However, the existing valve clip delivery device requires many steps to control the capturing control line, and the operation is relatively complicated and time-consuming. Summary of the invention

[0005] The technical problem to be solved by the present application is to provide a valve clip delivery device, in which the operator can choose between simultaneous control or separate control of the valve clip delivery device according to actual needs to improve the efficiency of the operation.

[0006] In order to achieve the above-mentioned purpose, the present application provides a valve clip delivery device for delivering and controlling a valve clip, wherein the valve clip includes at least two capture elements, the valve clip delivery device includes a sheath and a handle, the handle includes a shell and at least two control units, at least two capture control lines are movably passed through the sheath, and the two ends of each capture control line are respectively connected to the corresponding capture element and the control unit; each control unit is provided with a connecting portion, and one of the control units is rotated to force the corresponding connection portion to switch between connecting and disconnecting from each other relative to at least another of the connection portions; wherein, when the connection portions are connected to each other, at least any one of the control units is axially moved to simultaneously control the retraction or release of the capture elements via the capture control line; when the connection portions are disconnected from each other, each control unit is axially moved to individually control the retraction or release of the corresponding capture element via the capture control line.

[0007] The present application sets a connection part on the control unit, so that when the connection parts are connected to each other, any control unit is moved axially to achieve simultaneous control of the folding or releasing of the capture element; when the connection parts are disconnected from each other, each control unit is moved axially to achieve separate control of the folding or releasing of the capture element. At this time, the operator can choose to control the capture element in a simultaneous control mode or a separate control mode according to actual needs to improve the efficiency of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 A schematic diagram of the assembly of the valve clamping system provided in the first embodiment of the present application;

[0009] Figure 2 is a schematic assembly diagram of a partial structure of the valve clip delivery device in the first embodiment;

[0010] Figure 3 It is a schematic diagram of the three-dimensional structure of the valve clip in the valve clipping system;

[0011] Figure 4 is a schematic cross-sectional structure diagram of a sheath tube of the valve clip delivery device in the first embodiment;

[0012] Figure 5 It is a schematic diagram of the valve clip delivery device in the first embodiment controlling the bilateral release of the capture element;

[0013] Figure 6 It is a schematic diagram of the valve clip delivery device in the first embodiment controlling the bilateral retraction and capture elements;

[0014] Figure 7 It is a schematic diagram of the valve clip delivery device in the first embodiment controlling the unilateral release of the capture element;

[0015] Figure 8 It is a three-dimensional assembly diagram of a clamping control component and a release control component in a valve clip delivery device;

[0016] Fig. 9 for Figure 8 A three-dimensional exploded schematic diagram of a clamping control component;

[0017] Fig.10 for Fig. 9 The structural diagram of the fixed force gear in FIG.

[0018] Fig.11 for Fig. 9 Schematic diagram of the structure of the knob;

[0019] Fig.12a It is a cross-sectional structural schematic diagram of a control unit of a capture control assembly of a valve clip delivery device in the first embodiment;

[0020] Figure 12b for Fig.12a An enlarged schematic diagram of a local area I is shown;

[0021] Fig.13 for Fig.12a A three-dimensional exploded schematic diagram of the control unit;

[0022] Fig.14 for Fig.13 A schematic diagram of the cross-sectional structure of the middle movable rod;

[0023] Fig.15 for Fig.13 Schematic diagram of the three-dimensional structure of the operation body;

[0024] Fig.16 for Fig.13 A schematic diagram of the cross-sectional structure of the operating body;

[0025] Fig.17 for Fig.13 A schematic diagram of the three-dimensional structure of the elastic chuck;

[0026] Fig.18 for Fig.17 A schematic front view of the elastic collet shown;

[0027] Fig.19 is a three-dimensional schematic diagram of a fixing sleeve of the control unit in the first embodiment;

[0028] Fig. 20 for Figure 8 A three-dimensional exploded schematic diagram of the release control assembly and the transmission member;

[0029] Fig.21 for Fig. 20A schematic diagram of a three-dimensional structure in which a release control component and a transmission member are assembled together;

[0030] Fig. 22 A schematic diagram of operating the release control component to switch from a first state to a second state;

[0031] Fig.23 A schematic diagram of a partial three-dimensional exploded structure of a capture control assembly in a valve clip delivery device provided in a second embodiment of the present application;

[0032] Fig.24 for Fig.23 A schematic diagram of the state when the capture control component controls the capture element to be retracted;

[0033] Fig.25 for Fig.24 A cross-sectional view of the capture control assembly;

[0034] Fig.26 for Fig.23 A schematic diagram of the state when the capture control component controls the capture element to release;

[0035] Fig. 27 for Fig.26 A cross-sectional view of the capture control assembly;

[0036] Fig.28 A schematic diagram of the structure of a capture control component provided in the third embodiment of the present application;

[0037] Fig.29 for Fig.28 A schematic diagram of the cross-sectional structure of the center withdrawal line control unit;

[0038] Fig.30 is a schematic cross-sectional structural diagram of a sheath tube of a valve clip delivery device in a third embodiment;

[0039] Fig.31 A schematic diagram of the bilateral retracting and capturing elements of the retracting and releasing control unit of the valve clip delivery device in the third embodiment;

[0040] Fig.32 It is a schematic diagram of the bilateral release capture element of the retracting and extending control unit of the valve clip delivery device in the third embodiment;

[0041] Fig.33 It is a schematic diagram of the wire withdrawal control unit of the valve clip delivery device in the third embodiment withdrawing all the capture control wires;

[0042] Fig.34 A schematic diagram of the structure of a capture control assembly in a valve clip delivery device provided in a fourth embodiment of the present application;

[0043] Fig.35 for Fig.34 A schematic diagram of the three-dimensional structure of a control unit in the middle;

[0044] Fig.36 for Fig.35 An exploded schematic diagram of the control unit shown;

[0045] Fig.37 for Fig.35 A schematic diagram of the three-dimensional structure of a fixed sleeve in the control unit shown;

[0046] Fig.38 for Fig.37 A schematic diagram of the planar structure of the fixed sleeve shown;

[0047] Fig.39 It is a schematic diagram of the insertion block of the valve clip delivery device operation control unit in the fourth embodiment being inserted into the slot;

[0048] Fig.40 It is a schematic diagram of the valve clip delivery device in the fourth embodiment controlling the bilateral retracting capture element;

[0049] Fig.41 It is a schematic diagram of the valve clip delivery device controlling the bilateral release of the capture element in the fourth embodiment;

[0050] Fig.42 It is a schematic diagram of controlling the unilateral release of the capture element of the valve clip delivery device in the fourth embodiment. DETAILED DESCRIPTION

[0051] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below in conjunction with the accompanying drawings.

[0052] It should be understood that expressions such as "including" and "may include" that may be used in the present application indicate the existence of the disclosed functions, operations, or constituent elements, and do not limit one or more additional functions, operations, and constituent elements. In the present disclosure, terms such as "including" and / or "having" may be interpreted as indicating specific characteristics, numbers, operations, constituent elements, components, or combinations thereof, but may not be interpreted as excluding the existence or possibility of adding one or more other characteristics, numbers, operations, constituent elements, components, or combinations thereof.

[0053] In addition, in the present application, the expression "and / or" includes any and all combinations of the associated listed words. For example, the expression "A and / or B" may include A, may include B, or may include both A and B.

[0054] In the present application, expressions including ordinal numbers such as "first" and "second" can modify various elements. However, such elements are not limited by the above expressions. For example, the above expressions do not limit the order and / or importance of the elements. The above expressions are only used to distinguish one element from other elements. Similarly, without departing from the scope of the present disclosure, the first element can be referred to as the second element, and similarly, the second element can also be referred to as the first element.

[0055] When a component is referred to as being "connected" or "accessed" to another component, it should be understood that the component is not only directly connected to or accessed to the other component, but also another component may exist between the component and the other component. On the other hand, when a component is referred to as being "directly connected" or "directly accessed" to another component, it should be understood that there is no component between them.

[0056] In the field of interventional medical device technology, the direction close to the operator is generally defined as the proximal end, and the direction away from the operator is defined as the distal end. The direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction. The circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius). The radial direction refers to the direction along the diameter or radius. "Natural state" refers to the state in which the element is not subject to external forces and maintains its original shape. It is worth noting that the "end" appearing in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc., is not limited to the end, endpoint or end face, but also includes a portion extending an axial distance and / or radial distance from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs. The above definitions are only for convenience of expression and cannot be understood as limitations on the present invention.

[0057] See also Figure 1 and Figure 2 The valve clamping system 100 provided in the first embodiment of the present application is used for edge-to-edge repair of a heart valve (not shown, which may be a mitral valve or a tricuspid valve). The valve clamping system 100 includes a valve clip 20 and a valve clip delivery device 40. The valve clip 20 is detachably connected to the distal end of the valve clip delivery device 40, and is used to clamp at least two leaflets of the valve to perform edge-to-edge repair on the valve. The valve clip delivery device 40 is used to deliver and control the valve clip 20.

[0058] See also Figure 3 In the first embodiment, the valve clip 20 includes a supporting portion 21 , a driving element 23 , two clamping elements 25 and two capturing elements 28 .

[0059] The driving element 23 includes a driving shaft 231 and two driving arms 233. The proximal end of the driving shaft 231 is movably disposed in the support portion 21 and is detachably connected to the distal end of the valve clip delivery device 40. Preferably, the driving arm 233 is elastic, and the two driving arms 233 are respectively located on both sides of the driving shaft 231, and one end of each driving arm 233 is fixedly connected to the distal end of the driving shaft 231.

[0060] The two clamping elements 25 correspond to the two driving arms 233. The first end of each clamping element 25 is connected to the distal end of the support portion 21, and the second end is connected to the other end of the corresponding driving arm 233. The axial movement of the driving shaft 231 can enable the two driving arms 233 to drive the two clamping elements 25 to expand or close radially, thereby clamping the leaflets.

[0061] In this embodiment, the two clamping elements 25 and the two driving arms 233 are preferably an integral structure, that is, the two clamping elements 25 themselves are also elastic. When the driving shaft 231 moves axially toward the distal end, the two clamping elements 25 are relatively opened by overcoming the obstruction of the two driving arms 233. When the driving shaft 231 does not apply a thrust to the driving arms 233 or moves axially toward the proximal end, the two driving arms 233 use their own elastic reset or are driven by the driving shaft 231 to drive the two clamping elements 25 to close and abut against the support portion 21.

[0062] The two capture elements 28 correspond to the two clamping elements 25 one by one, and are used to cooperate with the clamping elements 25 to capture the valve leaflets. The first end of each capture element 28 is close to the first end of a clamping element 25, and the second end (free end) of each capture element 28 is connected to the valve clip delivery device 40. The capture element 28 has elastic deformation ability, and the second end of the capture element 28 approaches the second end of the corresponding clamping element 25 when no external force is applied. When in use, the valve clip delivery device 40 is used to first open the two clamping elements 25, and control the two capture elements 28 to retract, that is, the second end of the capture element 28 is relatively far away from the second end of the corresponding clamping element 25, and after the leaflet enters the space between the corresponding capture element 28 and the clamping element 25, the two capture elements 28 are controlled to be released, that is, the second end of the capture element 28 is pressed against the second end of the corresponding clamping element 25, and the leaflet is captured and positioned between the capture element 28 and the clamping element 25. After that, the valve clip delivery device 40 controls the clamping element 25 to close to perform valve edge-to-edge repair. The capture element 28 can also be provided with an anchor 281, which is used to press the leaflet into the inner surface of the clamping element 25 to improve the anchoring and retention of the leaflet.

[0063] It can be understood that in this embodiment, in order to adapt to mitral valve repair, the number of the clamping element 25, the driving arm 233, and the capturing element 28 are all two. In other embodiments, a person skilled in the art can select the appropriate number of the clamping element 25, the driving arm 233, and the capturing element 28 as needed, for example, the number of the clamping element 25, the driving arm 233, and the capturing element 28 are all three, so as to clamp the three leaflets of the tricuspid valve at the same time, thereby treating tricuspid valve regurgitation.

[0064] It is understood that the valve clip 20 is not limited to the above-mentioned Figure 2 The structure shown only needs to include a support portion, a clamping element, a capture element, and a drive element, and can clamp adjacent leaflets to perform edge-to-edge repair of the valve.

[0065] Please refer to Figure 1 , Figure 2 and Figure 4 The valve clip delivery device 40 includes a handle 42 and a sheath 44. The handle 42 is used to facilitate the operator to hold and control the valve clip 20. The proximal end of the sheath 44 is fixedly connected to the distal end of the handle 42, and the distal end of the sheath 44 extends to the valve clip 20. The valve clamping system 100 also includes an adjustable bending sheath 60, which includes a bending handle 62 and an outer sheath 64 connected to the bending handle 62 and controlled by the bending handle 62 to bend accordingly. The sheath 44 is movably inserted into the adjustable bending sheath 60, so that the distal end of the sheath 44 can bend accordingly to conform to the distal end of the outer sheath 64 to approach the target site.

[0066] The handle 42 includes a housing 422 , a clamping control assembly 424 , a catching control assembly 426 , and a release control assembly 432 . The clamping control assembly 424 , the catching control assembly 426 , and the release control assembly 432 are all disposed on the housing 422 .

[0067] In the present embodiment, the shell 422 includes a first shell 4221 and a second shell 4223 covering the first shell 4221. The shell 422 has a storage space (not shown) for accommodating the clamping control component 424, the capture control component 426 and the release control component 432. The connection method between the first shell 4221 and the second shell 4223 can be, but is not limited to, a snap-on, a threaded connection, etc. The clamping control component 424 is used to control the relative opening or closing of the two clamping elements 25. The capture control component 426 includes two control units 50. In the present embodiment, the two control units 50 are respectively located on opposite sides of the central axis of the shell 422 and the sheath 44, and are used to control the capture elements 28 on the corresponding side and facilitate distinction. In the present embodiment, each control unit 50 controls a capture element 28 correspondingly, so that the two capture elements 28 are in a released state (such as Figure 5 and Figure 7as shown, which may also be referred to as an expanded state) or a collapsed state (as shown Figure 6 The release control assembly 432 is used to release the valve clip 20 from the valve clip delivery device 40 after the valve clip 20 clamps and fixes the anterior leaflet and the posterior leaflet of the mitral valve.

[0068] See also Figures 8 to 11 The clamping control assembly 424 includes a core shaft 4241 and a transmission member 4242. The distal end of the core shaft 4241 is detachably connected to the proximal end of the drive shaft 231 of the valve clip 20. In the present embodiment, the distal end of the core shaft 4241 is threadedly connected to the proximal end of the drive shaft 231. It is understandable that the threaded connection between the distal end of the core shaft 4241 and the proximal end of the drive shaft 231 is not limited, and it can also be connected by other means, such as snap-on connection, etc., which is not limited here. The proximal end of the core shaft 4241 moves through the sheath 44 and is connected to the transmission member 4242. The transmission member 4242 is axially slidably connected to the housing 422. Please refer to Figure 4 A central cavity 443 is provided in the sheath tube 44 , and the core shaft 4241 is movably disposed in the central cavity 443 .

[0069] More specifically, the distal end of the transmission member 4242 is further provided with a first guide structure 4243, and the first shell 4221 of the shell 422 is provided with a second guide structure (not shown) corresponding to the first guide structure 4243. The first guide structure 4243 is slidably connected to the second guide structure along the axial direction to guide the axial movement of the transmission member 4242 relative to the shell 422, so that the transmission member 4242 can only move axially relative to the shell 422 but cannot rotate. In this embodiment, the first guide structure 4243 is a guide groove, and the second guide structure is a guide rail extending axially. It can be understood that the present application does not limit the first guide structure 4243 and the second guide structure. For example, in other embodiments, the first guide structure can be a guide rail, and the second guide structure can be a guide groove.

[0070] The clamping control assembly 424 also includes a fixed force gear 4244 and a knob 4245 for driving the fixed force gear 4244 to rotate. The fixed force gear 4244 is screwed onto the transmission member 4242. The rotation of the fixed force gear 4244 drives the transmission member 4242 to move axially, that is, the rotational motion of the fixed force gear 4244 is converted into the axial motion of the transmission member 4242 relative to the housing 422, thereby controlling the opening and closing of the two clamping elements 25.

[0071] In this embodiment, the outer wall of the transmission member 4242 includes a screw segment 4246 , and a transmission thread 4247 is provided on the inner wall of the stationary gear 4244 . The screw segment 4246 is adapted to the transmission thread 4247 provided in the stationary gear 4244 .

[0072] Please refer to Fig.11, the knob 4245 is sleeved on the fixed force gear 4244. When the knob 4245 rotates in the positive direction and the driving force of the knob 4245 on the fixed force gear 4244 is less than the preset force value, the knob 4245 drives the fixed force gear 4244 to rotate in the positive direction synchronously, so that the transmission member 4242 moves axially toward one end relative to the housing 422. For example, the knob 4245 drives the fixed force gear 4244 to rotate in the positive direction, and the transmission member 4242 and the core shaft 4241 move axially toward the proximal end, driving the two clamping elements 25 on the valve clip 20 to close relatively. And the greater the distance that the transmission member 4242 moves toward the proximal end, the tighter the two clamping elements 25 are closed.

[0073] When the knob 4245 rotates in the positive direction and the driving force of the knob 4245 on the fixed force gear 4244 is greater than or equal to the preset force value, the knob 4245 rotates independently relative to the fixed force gear 4244. For example, after the two clamping elements 25 clamp and fix the valve, if the knob 4245 continues to be rotated, the knob 4245 slips and rotates independently relative to the fixed force gear 4244, thereby preventing the clamping element 25 from excessively clamping the leaflet and damaging the leaflet. Even if the driving force of the knob 4245 on the fixed force gear 4244 is greater, once the driving force exceeds the preset force value, the force applied to the core shaft 4241 will not increase, which is conducive to protecting the core shaft 4241 from being broken or damaged due to excessive tension.

[0074] When the knob 4245 rotates in the opposite direction, the knob 4245 drives the fixed force gear 4244 to rotate in the opposite direction synchronously, so that the transmission member 4242 slides axially toward the opposite end relative to the housing 422. For example, the knob 4245 drives the fixed force gear 4244 to rotate in the opposite direction, and the transmission member 4242 and the core shaft 4241 move axially toward the distal end, driving the two clamping elements 25 on the valve clip 20 to open relative to each other. And the greater the distance that the transmission member 4242 moves toward the distal end, the greater the angle of the relative opening of the two clamping elements 25.

[0075] See also Fig.10 The fixed force gear 4244 includes a wheel body 4248 and a plurality of tooth arms 4249 protruding from the outer wall of the wheel body 4248 and spaced apart in the circumferential direction. The inner wall of the knob 4245 is provided with a plurality of stoppers 4250 cooperating with the plurality of tooth arms 4249 in the circumferential direction; the preset force value is the value of the force applied by the knob 4245 to the fixed force gear 4244 when the tooth arms 4249 slide relatively over the stoppers 4250.

[0076] One end of the tooth arm 4249 is fixedly connected to the outer wall of the wheel body 4248 , and the other end of the tooth arm 4249 is a free end. At least part of the outer wall of the tooth arm 4249 extends along the circumference of the wheel body 4248 .

[0077] A gap 4252 (eg, Fig.10As shown), thereby providing deformation space for the elastic deformation of the tooth arm 4249.

[0078] The preset force value can be controlled by setting the maximum outer diameter of the fixed force gear 4244, the thickness of the tooth arm 4249, the material of the fixed force gear 4244, etc. In this embodiment, the number of tooth arms 4249 arranged along the circumference of the wheel body 4248 is 8, the preset force value is about 50N, the material of the fixed force gear 4244 is preferably a polymer PC material with high hardness and toughness, the maximum outer diameter value is set to 35mm-40mm, and the thickness of the tooth arm 4249 is set to 1.5mm-2.0mm. When the tension value of the core shaft 4241 is greater than a certain force value, the knob 4245 and the fixed force gear 4244 will slip relative to each other. Even if the driving force of the knob 4245 on the fixed force gear 4244 is greater, once the driving force exceeds the preset force value, the core shaft 4241 will stop moving axially, and the force applied to the core shaft 4241 will no longer increase.

[0079] The free end of the tooth arm 4249 includes a first sliding guide surface 4254 and a first anti-slip surface 4256 disposed opposite to the first sliding guide surface 4254 .

[0080] Please refer again Fig.11 The stopper 4250 of the knob 4245 includes a second guide sliding surface 4258 and a second anti-slip surface 4259 disposed opposite to the second guide sliding surface 4258. When the knob 4245 rotates in the forward direction, the first guide sliding surface 4254 contacts the second guide sliding surface 4258, so that when the knob 4245 rotates in the forward direction and the driving force of the knob 4245 on the fixed force gear 4244 is greater than or equal to the preset force value, the tooth arm 4249 of the fixed force gear 4244 can slide over the stopper 4250. When the knob 4245 rotates in the reverse direction, the first anti-slip surface 4256 contacts the second anti-slip surface 4259, so that the fixed force gear 4244 rotates in the reverse direction along with the knob 4245.

[0081] In this embodiment, the first guide surface 4254 is inclined relative to the first anti-slip surface 4256, and the first anti-slip surface 4256 extends approximately along the radial direction of the wheel body 4248; the second guide surface 4258 is inclined relative to the second anti-slip surface 4259, and the second anti-slip surface 4259 extends approximately along the radial direction of the knob 4245. The contact between the first guide surface 4254 and the second guide surface 4258 is an inclined surface contact, and the second guide surface 4258 presses the first guide surface 4254 toward the gap 4252, so that the first guide surface 4254 and the second guide surface 4258 are relatively easy to slide relative to each other; while the contact between the first anti-slip surface 4256 and the second anti-slip surface 4259 is basically a straight surface contact, and the second anti-slip surface 4259 pushes the first anti-slip surface 4256 in a direction away from the gap 4252, so that the first anti-slip surface 4256 and the second anti-slip surface 4259 are not easy to slide relative to each other. It can be understood that in other embodiments, different degrees of roughness can be set on each surface to make it easier for the first sliding guide surface 4254 and the second sliding guide surface 4258 to slide relative to each other, while it is difficult for the first anti-slip surface 4256 and the second anti-slip surface 4259 to slide relative to each other. For example, the roughness of the first sliding guide surface 4254 can be smaller than that of the first anti-slip surface 4256, and the roughness of the second sliding guide surface 4258 can be smaller than that of the second anti-slip surface 4259.

[0082] Please refer to Figure 2 , Fig.12a , Figure 12b and Fig.13 Each control unit 50 includes a movable rod 51, an operating member 53 and a capture control line 55. The movable rod 51 is movably provided on the housing 422. The operating member 53 is movably connected to the proximal end of the movable rod 51, and the operating member 53 can move axially relative to the movable rod 51. The capture control line 55 is connected to the capture element 28 and is movably provided in the sheath 44, the movable rod 51 and the operating member 53. The operating member 53 is used to clamp or release the capture control line 55.

[0083] The proximal end of the movable rod 51 is provided with a mounting hole 511 for receiving the operating member 53. Fig.14 The mounting hole 511 includes a tapered hole section 5111 and a threaded hole section 5113 which are connected to each other. The inner diameter of the tapered hole section 5111 gradually decreases from its proximal end to its distal end. Compared with the tapered hole section 5111, the threaded hole section 5113 is closer to the proximal opening of the mounting hole 511. The threaded hole section 5113 is used to be threadedly connected with the outer wall of the operating member 53, so that the operating member 53 can move along the axial direction of the movable rod 51 while rotating relative to the movable rod 51.

[0084] The inner wall of the mounting hole 511 is also provided with a stop step 5115 for abutting against the outer wall of the operating member 53, so as to remind the operator that the predetermined position has been reached when the operating member 53 moves axially from the proximal end to the distal end. In this embodiment, the stop step 5115 is provided between the threaded hole section 5113 and the proximal opening of the mounting hole 511.

[0085] The operating member 53 includes an operating body 531 and an elastic clamp 533. Figure 12b , Fig.13 , Fig.15 and Fig.16 The operating body 531 is movably received in the mounting hole 511. The operating body 531 is provided with a receiving hole 5310 along the axial direction for receiving the elastic clamp 533. The outer wall of the operating body 531 is provided with a thread 5311 screwed with the threaded hole section 5113, so that the operating member 53 can rotate relative to the movable rod 51 and move axially relative to the movable rod 51.

[0086] A convex portion 5313 is provided on the outer wall of the operating body 531 for abutting against the end step 5115 so as to remind the operator that the predetermined position has been reached when the operating member 53 moves axially from the proximal end to the distal end.

[0087] The elastic clamp 533 is received in the receiving hole 5310 of the operating body 531, and thus received in the mounting hole 511. When the operating member 53 moves axially relative to the movable rod 51, the elastic clamp 533 cooperates with the inner wall of the mounting hole 511 to clamp or loosen the capture control line 55. The operating body 531 is rotated so that the operating member 53 moves from the proximal end to the distal end along the axial direction of the movable rod 51 until the elastic clamp 533 is squeezed by the inner wall of the mounting hole 511, and the elastic clamp 533 is elastically deformed to clamp the capture control line 55, thereby fixing the capture control line 55 on the operating member 53.

[0088] When the capture control line 55 is fixed to the operating member 53, the operator can control the movable rod 51 to move axially. When the movable rod 51 moves from the distal end to the proximal end, the capture control line 55 can be tightened to control the capture element 28 to retract, that is, the second end of the capture element 28 moves closer to the support portion 21, so that the leaflet can enter between the capture element 28 and the clamping element 25. When the movable rod 51 moves from the proximal end to the distal end, the capture control line 55 can be released, and the second end of the capture element 28 is no longer pulled by the capture control line 55 and pressed toward the clamping element 25, and the capture element 28 can cooperate with the clamping element 25 to capture the leaflet. In this way, the operator can easily control the retraction and release of the capture element 28.

[0089] When the capture control line 55 needs to be withdrawn, the operator can simply reversely rotate or unscrew the operating body 531, so that the operating member 53 moves toward the proximal end relative to the mounting hole 511 along the axial direction of the movable rod 51, and the elastic clamp 533 is freed from the restraint of the inner wall of the mounting hole 511 and automatically recovers elastically to loosen the capture control line 55. After that, the operator can easily withdraw the capture control line 55. It can be seen that the valve clip delivery device 40 provided by the present application only needs to unscrew the operating body 531 to make the elastic clamp 533 loosen the capture control line 55, which can simplify the steps of controlling the withdrawal of the capture control line 55, save operation time, improve operation efficiency, and make the valve clip delivery device 40 more convenient to control the capture control line 55.

[0090] It can be understood that the present application does not limit the number of capture elements 28 and the number of capture control units 50. In other embodiments, the number of capture elements 28 can be more than two, the number of capture control units 50 can be more than two, and one capture control unit 50 controls one capture element 28.

[0091] The material of the elastic clamp 533 can be stainless steel, copper alloy, elastic polymer material, etc. In this embodiment, copper alloy is preferably used to make the elastic clamp 533 easy to produce elastic deformation and have excellent elastic recovery performance. Fig.17 and Fig.18 , the elastic clamp 533 includes two elastic parts 5331. In the natural state, there is a gap 5333 between two adjacent elastic parts 5331. The operating body 531 is rotated in the forward direction, so that the elastic clamp 533 moves toward the distal end along the axial direction of the movable rod 51, and the inner wall of the mounting hole 511 squeezes the elastic clamp 533, forcing the two elastic parts 5331 to gather together to reduce the gap 5333 until the capture control line 55 is clamped. The operating body 531 is rotated in the reverse direction, so that the elastic clamp 533 moves toward the proximal end along the axial direction of the movable rod 51, and the elastic clamp 533 is freed from the restraint of the inner wall of the mounting hole 511, and the two elastic parts 5331 are elastically restored and move away from each other to loosen the capture control line 55. It can be understood that the number of elastic parts 5331 is not limited to two, and can also be more than two.

[0092] Specifically, each elastic part 5331 includes a tapered section 5335. The outer diameter of the tapered section 5335 gradually decreases from its proximal end to its distal end. The tapered section 5335 is used to cooperate with the inner wall of the tapered hole section 5111. When the inner wall of the tapered hole section 5111 squeezes the tapered section 5335, the two elastic parts 5331 gather together; when the inner wall of the tapered hole section 5111 releases the tapered section 5335, the two elastic parts 5331 move away from each other.

[0093] Each elastic part 5331 has a clamping surface 5337. In a natural state, there is a gap 5333 between two adjacent clamping surfaces 5337. The capture control line 55 is passed through the gap 5333, that is, the capture control line 55 is located between the clamping surfaces 5337 of the two elastic parts 5331, and the capture control line 55 can move relative to the elastic clamp 533. When the elastic clamp 533 is squeezed to bring the two elastic parts 5331 together, the clamping surfaces 5337 of the two elastic parts 5331 clamp the capture control line 55. There is a smooth transition between the distal end surface of the elastic part 5331 and the clamping surface 5337 of the elastic part 5331 to avoid cutting the capture control line 55.

[0094] Furthermore, an anti-slip structure 5339 is provided on the clamping surface 5337 to improve the firmness of the elastic clamp 533 in clamping and capturing the control line 55. The anti-slip structure 5339 can be obtained by roughening the clamping surface 5337, such as providing wavy patterns. It can be understood that the anti-slip structure 5339 can be omitted, or the anti-slip structure 5339 is provided on at least one clamping surface 5337.

[0095] The elastic chuck 533 further includes a mounting portion 5340, and the proximal end of the tapered section 5335 is fixedly connected to the distal end of the mounting portion 5340. The outer diameter of the proximal end of the tapered section 5335 is greater than the outer diameter of the distal end of the mounting portion 5340. The distal end surface of the operating body 531 abuts against the proximal end surface of the tapered section 5335.

[0096] In this embodiment, the cone angle of the conical hole section 5111 (eg Fig.14 The range of the cone angle A1 shown is [50°, 60°], and the cone angle of the cone section 5335 (such as Fig.18 The range of the cone angle A2 shown is [30°, 40°]. The minimum aperture of the mounting hole 511 (eg Fig.14 The diameter of the mounting portion 5340 (e.g. Fig.18 D3 in the figure is preferably set to [3.2 mm, 3.8 mm]. The operating body 531 is used to accommodate the receiving hole 5310 (such as Fig.16 The maximum diameter of the tapered section 5335 of the elastic chuck 533 (eg Fig.18 D2) in the figure is set to [5.0mm, 5.5mm], and the maximum diameter of the tapered section 5335 is larger than the aperture of the receiving hole 5310, so that the proximal end of the tapered section 5335 can be supported by the distal end of the operating body 531.

[0097] It can be understood that in other embodiments, the operating body 531 can be integrally arranged with the elastic clamp 533, the elastic clamp 533 is accommodated in the mounting hole 511, the capture control line 55 passes through the elastic clamp 533, and a supporting structure can be provided on the inner wall of the mounting hole 511. The operating member 53 only makes axial movement relative to the movable rod 51, and the elastic clamp 533 can also clamp or loosen the capture control line 55.

[0098] Please refer again Figure 3 Each capture control line 55 is U-shaped, including a folded section 551, a first connecting section 553 and a second connecting section 555 (the first connecting section 553 and the second connecting section 555 are considered as one strand). The first connecting section 553 and the second connecting section 555 extend from both sides of the folded section 551. Please refer to Figure 4 Four first sub-cavities 444 are arranged in the sheath 44, and the first connecting section 553 and the second connecting section 555 of each capture control line 55 correspondingly move through a first sub-cavity 444 and extend to pass through the corresponding elastic clamp 533; the folded section 551 is movably connected to the capture element 28, specifically, the folded section 551 moves through the threading hole (not marked) opened on the capture element 28.

[0099] The capture control line 55 is U-shaped and connected to the operating member 53 in a one-cavity-one-wire manner, which can prevent the two connecting sections 553 and 555 of the same capture control line 55 from being entangled with each other, thereby making it smoother and easier to withdraw the capture control line 55, avoiding the risk of pulling or breaking the line, and improving the safety of line withdrawal.

[0100] The stroke of the movable rod 51 should be no less than 2πR×θ / 360, wherein R is the length between the first end and the second end of the capture element 28, θ is the absolute value of the difference between the first angle and the second angle, the first angle is the angle between the capture element 28 and the central axis of the valve clip 20 (the central axis of the drive shaft 233) when the capture element 28 is relatively close, and the second angle is the maximum angle between the capture element 28 and the central axis of the valve clip 20 after the capture element 28 is radially deployed. When the capture element 28 is retracted or relatively close, the first angle between the capture element 28 and the central axis of the valve clip 20 can be 0 degrees; after the capture element 28 is released or deployed, the second angle between the capture element 28 and the central axis of the valve clip 20 can be less than 90 degrees, equal to 90 degrees or greater than 90 degrees. Taking into account the loss of the capture control line 55 in the first sub-chamber 444, the effective propulsion stroke of the movable rod 51 is preferably set to 2×(2πR×θ / 360). On the one hand, the capture control line 55 will not be broken or damaged when the capture element 28 is retracted. On the other hand, the capture control line 55 will not be excessively stacked when the capture element 28 is released.

[0101] See also Fig.19 , combined with Figures 5 to 7 The control unit 50 further includes a fixed sleeve 57, which is fixedly received in the housing 422. The fixing method of the fixed sleeve 57 in the housing 422 can be selected from snap-fitting, bonding, screwing, etc., which are not limited here. The movable rod 51 is movably arranged in the fixed sleeve 57. A first guide portion 513 is provided on the outer wall of the movable rod 51, and a second guide portion 571 is provided on the inner wall of the fixed sleeve 57. The first guide portion 513 and the second guide portion 571 are used to guide the axial movement of the movable rod 51 relative to the fixed sleeve 57.

[0102] In this embodiment, the first guide portion 513 is a guide protrusion, and the second guide portion 571 is a guide groove provided on the inner wall of the fixed sleeve 57. The proximal end of the fixed sleeve 57 is further provided with a limit groove 573 connected with the guide groove. The limit groove 573 extends along the circumference of the fixed sleeve 57 and has a limit step 575. The limit groove 573 is generally an arc groove. When the guide protrusion of the movable rod 51 abuts against the bottom surface of the limit groove 573, the movable rod 51 cannot move toward the distal end relative to the fixed sleeve 57. The starting end surface of the limit groove 573 is flush with one wall surface of the first guide portion 513, and the limit step 575 is located between the terminal end surface 577 of the limit groove 573 and the other wall surface of the second guide portion 571. The limit step 575 is used to limit the first guide portion 513 in the limit groove 573 to prevent the first guide portion 513 from escaping from the limit groove 573. When the first guide portion 513 is received in the limiting groove 573 and abuts against the limiting step 575 , the capture control line 55 is in a tightened or straightened state, and the capture control line 55 pulls the capture element 28 to retract the capture element 28 .

[0103] The material of the capture control line 55 can be nickel-titanium wire, stainless steel wire, or high molecular polymer wire. In this example, high-strength nickel-titanium wire material is preferably used to reduce the risk of wire breakage.

[0104] The movable rod 51 can be operated to control the catching element 28 to be retracted or released, so that the catching element 28 cooperates with the clamping element 25 to capture the leaflet. The two control units 50 can be operated at the same time, for example, see Figure 5 , the movable rods 51 of the two control units 50 can be synchronously operated to move from the proximal end to the distal end (for example Figure 5 The arrows 301 and 302 indicate the directions indicated by the arrows 301 and 302 shown in the figure, that is, the valve clip delivery device 40 controls the bilateral capture elements 28 to release simultaneously, and the two capture control lines 55 are in a relaxed state. Under the elastic action of the capture element 28 itself, the end of the capture element 28 connected to the capture control line 55 is pressed against the clamping element 25 to cooperate with the clamping element 25 to capture the valve leaflet. For another example, please refer to Figure 6 , the movable rods 51 of the two control units 50 are synchronously operated to move from the distal end to the proximal end (for example Figure 6The valve clip delivery device 40 controls the bilateral capturing elements 28 to be retracted simultaneously, so that each capturing control line 55 pulls up the corresponding capturing element 28, thereby forming a storage space for accommodating the leaflets between the capturing element 28 and the corresponding clamping element 25 (not shown in the figure), and the leaflets can enter the storage space.

[0105] Of course, the unilateral capture element 28 can also be controlled to capture the dynamic anterior leaflet or posterior leaflet. After the unilateral leaflet is captured successfully and the angle is adjusted, the other capture element 28 can be controlled to capture the dynamic posterior leaflet or anterior leaflet on the other side, thereby reducing the difficulty of capturing the leaflet, improving the capture efficiency and the success rate of the operation. For example, please refer to Figure 7 , a movable rod 51 of a control unit 50 extends from the proximal end to the distal end (eg Figure 7 The movable rod 51 of another control unit 50 moves from the distal end to the proximal end (eg, Figure 7 The valve clip delivery device 40 controls the capture element 28 on one side to release.

[0106] See also Fig. 20 and Fig.21 The release control assembly 432 includes a core rod 4322, a gear 4324 and a safety switch 4326. The core rod 4322 is movably inserted into the transmission member 4242 and fixedly connected to the proximal end of the core shaft 4241. The gear 4324 is fixedly sleeved on the core rod 4322 and accommodated in the transmission member 4242. At least one elastic pawl (not shown) is arranged in the transmission member 4242. The elastic pawl cooperates with the gear 4324 to only allow the gear 4324 to rotate in one direction, thereby only allowing the core rod 4322 to drive the core shaft 4241 to rotate in one direction, so as to release the connection between the core shaft 4241 and the driving shaft 231 of the valve clip 20, so that the valve clip 20 is separated from the core shaft 4241.

[0107] In this embodiment, the distal end of the core shaft 4241 is threadedly connected to the proximal end of the driving shaft 231. The distal end of the core rod 4322 is provided with at least a first anti-rotation surface 4332, and the inner wall of the one-way gear 4324 is provided with a second anti-rotation surface 4334 corresponding to the first anti-rotation surface 4332. The first anti-rotation surface 4332 cooperates with the second anti-rotation surface 4334 to prevent the one-way gear 4324 and the core rod 4322 from rotating relative to each other.

[0108] The transmission member 4242 is provided with an axial hole 401 along the axial direction, and the core rod 4322 is penetrated through the axial hole 401. A connecting hole 403 communicating with the axial hole 401 is provided on the outer wall of the transmission member 4242. The safety switch 4326 passes through the connecting hole 403.

[0109] The release control component 432 includes a first state and a second state; when the release control component 432 is in the first state, the safety switch 4326 is abutted against the core rod 4322, and the core rod 4322 and the transmission member 4242 are connected as a whole; when the release control component 432 is in the second state, the safety switch 4326 is separated from the core rod 4322, driving the core rod 4322 to rotate unidirectionally relative to the transmission member 4242, thereby driving the distal end of the core shaft 4241 to detach from the valve clip 20.

[0110] The release control assembly 432 further includes an elastic member 4328, which extends in the axial direction and abuts between the core rod 4322 and the transmission member 4242. In this embodiment, the elastic member 4328 is sleeved on the core rod 4322 and received in the shaft hole 401.

[0111] The release control assembly 432 also includes a release knob 4329 , which is fixed to the proximal end of the core rod 4322 to facilitate the rotation of the core rod 4322 .

[0112] When the release control assembly 432 needs to be switched from the first state to the second state, the safety switch 4326 is lifted in a direction away from the spindle 4241 (for example, Fig. 22 When the release control assembly 432 is in the second state, the release knob 4329 can be rotated in one direction (for example, Fig. 22 The transmission member 4242 is stationary relative to the housing 422, and the release knob 4329 drives the core rod 4322 and the core shaft 4241 to rotate relative to the transmission member 4242. Once the distal end of the core shaft 4241 is separated from the driving shaft 231 of the valve clip 20, the pre-compressed elastic member 4328 automatically pops open, driving the core rod 4322 and the core shaft 4241 to retreat proximally (for example, Fig. 22 The valve clip 20 is in the direction indicated by the middle arrow 309, indicating that the threaded connection between the distal end of the core shaft 4241 and the driving shaft 231 of the valve clip 20 has been released, and the valve clip 20 has been released.

[0113] When the release control assembly 432 needs to be switched from the second state to the first state, the safety switch 4326 is pressed so that the safety switch 4326 abuts against the core rod 4322. The safety switch 4326 and the core rod 4322 abut to form a whole. The axial movement of the transmission member 4242 can drive the core shaft 4241, the core rod 4322, etc. to move synchronously.

[0114] Since the release control assembly 432 is provided with a safety switch 4326, the connection between the mandrel 4241 and the valve clip 20 can be released only after the safety switch 4326 is pulled up (i.e., when the release control assembly 432 is in the second state), which prevents misoperation and accidental release of the valve clip 20, thereby improving surgical safety. The cooperation between the gear 4324 and the pawl only allows the mandrel 4322 to drive the mandrel 4241 to rotate in the direction of releasing the threaded connection, thereby efficiently releasing the connection between the mandrel 4241 and the driving shaft 231 of the valve clip 20.

[0115] The following is a brief description of the working process of the valve clipping system 100. The valve clip 20 is delivered to the vicinity of the mitral valve of the patient via a valve clip delivery device 40 via a transcatheter method.

[0116] In the initial state, the first connecting section 553 and the second connecting section 555 of each capture control line 55 are clamped in an elastic clamp 533. Both movable rods 51 are pulled back toward the proximal end and limited by the limiting step 575, so that the two capture elements 28 are in the retracted state. The safety switch 4326 is in contact with the core rod 4322, and the transmission member 4242 and the core rod 4322 form a whole.

[0117] The operator adjusts the degree of curvature of the adjustable sheath 60, and the sheath tube 44 passing through the adjustable sheath 60 conforms to the adjustable sheath 60, so that the valve clip 20 is delivered to a predetermined position near the patient's mitral valve.

[0118] Then, the clamping elements 25 of the valve clip 20 are controlled to open by the clamping control component 424 , for example, the knob of the clamping control component 424 is rotated in reverse so that the two clamping elements 25 are relatively opened.

[0119] The capture control component 426 is then used to control the capture element 28 to capture the bilateral or unilateral leaflets between the corresponding clamping element 25 and the capture element 28. For example, a movable rod 51 can be pushed forward distally to capture one leaflet, and then another movable rod 51 can be pushed forward distally to capture the other leaflet.

[0120] Next, the two clamping elements 25 are controlled to close by the clamping control component 424 to clamp the anterior leaflet and the posterior leaflet of the mitral valve together. For example, the knob 4245 of the clamping control component 424 is rotated forward to close the two clamping elements 25 to clamp the leaflets.

[0121] Once the leaflets of the mitral valve are aligned edge to edge, the operating body 531 is loosened, and the operating body 531 moves proximally relative to the movable rod 51. The elastic clamp 533 loses the support of the operating body 531 and the restraint of the inner wall of the mounting hole 511 in the operating body 531, and automatically recovers elastically to loosen the two connecting sections 553, 555 of the capture control line 55. The operator can pull one of the two connecting sections 553, 555 to withdraw the corresponding capture control line 55 from the body. The other capture control line 55 is withdrawn from the body in the same way.

[0122] The operator pulls up the safety switch 4326 to separate the safety switch 4326 from the core rod 4322, rotates the release knob 4329 of the release control assembly 432, releases the connection between the core shaft 4241 and the drive shaft 231 of the valve clip 20, and withdraws the valve clip delivery device 40 from the body, while retaining the valve clip 20 at the valve, thereby achieving "edge-to-edge repair" of the mitral valve.

[0123] It can be understood that the valve clamping system 100 of the present application can also perform edge-to-edge repair on the tricuspid valve, as long as the corresponding interventional pathway is selected and an appropriate number of valve clips are implanted according to the number of leaflets that need to be repaired (such as implanting three valve clips to respectively clamp the anterior leaflet and posterior leaflet, the posterior leaflet and the septal leaflet, and the septal leaflet and the anterior leaflet of the tricuspid valve).

[0124] See also Figure 23 to Figure 27 The valve clip delivery device provided in the second embodiment of the present application has a substantially similar structure to the valve clip delivery device provided in the first embodiment. The movable rod 51 includes a rod body 515 and a cap body 517 disposed at the proximal end of the rod body 515 and radially protruding from the rod body 515. The first guide portion 513 is a guide protrusion, and the second guide portion 571 is a guide groove. The guide protrusion is disposed on the rod body 515, and the rod body 515 can be movably inserted into the fixed sleeve 57.

[0125] Please check Fig.19 The structure of the fixed sleeve 57 is similar to that of the fixed sleeve 57 of the first embodiment, except that the limiting groove 573 is provided at the distal end of the fixed sleeve 57, and each control unit (not shown) further includes an elastic member 578, which is sleeved on the rod body 515, and the two ends of the elastic member 578 respectively abut against the proximal end of the fixed sleeve 57 and the cap body 517. Fig.24 and Fig.25 When the first guide portion 513 is located in the second guide portion 571, that is, when the guide protrusion is located in the guide groove, the elastic member 578 is in a naturally extended state, so that the movable rod 51 moves axially toward the proximal end to tighten the corresponding capture control line 55 and retract the corresponding capture element 28. Fig.26 and Fig. 27The first guide portion 513 is located in the limiting groove 573, that is, when the guide protrusion is received in the limiting groove 573 and is clamped with the limiting step 575, the elastic member 578 is axially compressed to release the corresponding capture control line 55, that is, to control the corresponding capture element 28 to be released.

[0126] Assume that the axial dimension of the elastic member 4328 in the natural state is C1, and the axial dimension of the elastic member 578 after compression is C2. In this embodiment, the value range of C2 is preferably [10.0mm, 12.0mm], so as to ensure that the resistance of the elastic member 4328 to the movable rod 51 after compression is not too large, and reduce the difficulty of pushing the movable rod 51 to the far end to compress the elastic member 578; the difference between C1 and C2 should be able to ensure that the effective stroke of the movable rod 51 is sufficient.

[0127] During the actual surgical operation, repeated attempts are required to capture the valve leaflet, that is, the movable rod 51 needs to be repeatedly pulled or pushed to control the retraction and extension of the capturing element. For example, in the first embodiment, the movable rod needs to be manually pulled and pushed repeatedly, but for the valve clip delivery device provided in the second embodiment, pulling the movable rod toward the proximal end is automatically performed. It is only necessary to slightly rotate the movable rod 51 so that the first guide portion 513 is aligned with the second guide portion 571, and then the elastic member 578 automatically pulls the movable rod 51 due to its own elastic reset, tightens the capturing control line, and retracts the capturing element 28, thereby further reducing the operating steps and making the operation more convenient.

[0128] See also Figures 28 to 33 The valve clip delivery device provided in the third embodiment of the present application has a substantially similar structure to the valve clip delivery device provided in the first embodiment. The capture control assembly includes two control units 50. The difference is that the two control units 50 are respectively a retracting and releasing control unit 501 and a thread withdrawal control unit 503. Figure 3 , the first connection section 553 of each capture control line 55 is clamped or released by the elastic clamp 533 in the retracting and releasing control unit 501, and the second connection section 555 of each capture control line 55 is always clamped by the elastic clamp 533 in the line withdrawal control unit 503. The structures of the retracting and releasing control unit 501 and the line withdrawal control unit 503 are roughly similar, but the limiting groove 573 of the fixed sleeve 57 in the retracting and releasing control unit 501 is arranged at the proximal end of the corresponding fixed sleeve 57 (same as the first embodiment), while the limiting groove 573 of the fixed sleeve 57 in the line withdrawal control unit 503 is arranged at the distal end of the corresponding fixed sleeve 57 (such as Fig.29 shown).

[0129] See also Fig.30In the third embodiment, the sheath tube 44 includes a central cavity 443, two first sub-cavities 444 and a second sub-cavity 446. The central cavity 443 is located on the axis of the sheath tube 44, and the two first sub-cavities 444 and the second sub-cavity 446 are arranged around the central cavity 443. The mandrel 4241 is movably arranged in the central cavity 443. The first connecting section 553 of each capture control line 55 is movably arranged in a first sub-cavity 444, and the second connecting section 555 of each capture control line 55 is commonly arranged in the second sub-cavity 446. The first connecting section 553 of each capture control line 55 is clamped or loosened by the elastic clamp 533 in the retracting and releasing control unit 501, and the second connecting section 555 of each capture control line 55 is always clamped by the elastic clamp 533 in the line withdrawal control unit 503.

[0130] The third embodiment can control the simultaneous retraction or release of the bilateral capture elements 28 by pulling or pushing the active rod 51 of the retractable control unit 501 with one hand, further simplifying the control operation of the capture elements 28. Specifically: the active rod 51 of the retractable control unit 501 is moved from the distal end to the proximal end (for example, Fig.31 The retracting and releasing control unit 501 controls the bilateral catching elements 28 to be retracted at the same time (as indicated by the arrow 310). Fig.31 When the guide protrusion on the movable rod 51 of the operation and release control unit 501 is located in the corresponding limit groove 573 of the fixed sleeve 57 and is clamped with the limit step 575 (refer to Fig.19 ), the bilateral catching elements 28 remain in the retracted state. The movable rod 51 of the retractable control unit 501 is operated by one hand from the proximal end to the distal end (for example Fig.32 When the movement is in the direction indicated by the middle arrow 311), the retracting and releasing control unit 501 controls the capture elements 28 on both sides to release at the same time (such as Fig.32 shown).

[0131] When the retracting and releasing control unit 501 controls the catching elements 28 on both sides to be retracted or released simultaneously, the elastic clamp 533 in the retracting and releasing control unit 501 clamps all the first connecting sections 553, and the first guide portion 513 (guide protrusion) on the movable rod 51 of the thread withdrawal control unit 503 keeps cooperating with the limiting step (not shown) on the fixed sleeve 57 (as shown in the figure). Fig.29 As shown in FIG. 1 ), the operating member 53 of the thread withdrawal control unit 503 is kept tightened, so that the elastic clamp 533 of the thread withdrawal control unit 503 clamps all the second connecting segments 555. After the process of the release and retraction control unit 501 controlling the capture element 28 to release is completed, the operating body 531 (e.g. Fig.33The elastic clamp 533 in the retracting and releasing control unit 501 releases all the first connecting segments 553, and then the movable rod 51 in the thread withdrawal control unit 503 is rotated to align the first guide portion 513 on the movable rod 51 of the thread withdrawal control unit 503 with the corresponding second guide portion 571 of the fixed sleeve, and the thread is withdrawn toward the proximal end (for example, Fig.33 By using the movable rod 51 of the line withdrawal control unit 503 (in the direction indicated by the arrow 313), the two capture control lines 55 can be withdrawn at the same time by controlling the withdrawal with one hand, which further simplifies the withdrawal operation of the capture control lines.

[0132] It can be understood that the present embodiment does not limit the position of the cavity of the sheath 44 through which the first connecting section 553 and the second connecting section 555 of each capture control line 55 are passed. For example, the second connecting section 555 of each capture control line 55 can be respectively passed through a wire passing cavity, or the first connecting section 553 of each capture control line 55 can be passed through the same cavity together.

[0133] See also Figures 34 to 42 The valve clip delivery device provided in the fourth embodiment of the present application has a substantially similar structure to the valve clip delivery device provided in the first embodiment, except that: the capture control assembly 426 includes two control units, the two control units are adjacent and located on the same side of the central axis of the shell, a slot 518 is provided on the movable rod 51 of one of the control units, and an insert block 519 is protruding from the movable rod 51 of the other control unit; the movable rod 51 of at least one control unit 50 is rotated, and the insert block 519 is embedded in the slot 518, so that the movable rods 51 of the two control units are connected.

[0134] See also Figure 34 to Figure 36 Each movable rod 51 includes a rod body 515 and a cap body 517. A first guide portion or a guide protrusion 513 is protrudingly provided on the rod body 515. The cap body 517 of each control unit 50 is provided with a slot 518 and an insert 519 along the radial direction. The axial size of the slot 518 (e.g. Fig.36 B1 in the figure should be slightly larger than the axial dimension of the plug 519 (e.g. Fig.36 B2), after at least one movable rod 51 rotates, the insert block 519 can be easily inserted into the slot 518 of another movable rod 51.

[0135] See also Fig.37 and Fig.38, two guide grooves 571 are provided in the fixed sleeve 57 of at least one control unit 50, and the limiting step 575 is located between the two guide grooves 571, so that the corresponding movable rod 51 can still align with a guide groove 571 after rotation and can move axially relative to the fixed sleeve. In this embodiment, the slot 518 and the insert block 519 on the same movable rod 51 are arranged opposite to each other, and the angle between the two guide grooves 571 is preferably in the range of [90°, 180°], and more preferably 90°.

[0136] In this embodiment, the rotation (eg Fig.39 After the insert block 519 of a control unit 50 is inserted into the slot 518, it can be pulled toward the proximal end by one hand (for example Fig.40 320 in the figure) or distally (eg Fig.41 The movable rod 51 of any control unit 50 can simultaneously control the catching elements 28 on both sides to be retracted or released. Fig.42 As shown, when the movable rods 51 of the two control units 50 are not connected, that is, when no insert block 519 is inserted into the slot 518, the movable rods 51 of each control unit 50 can be used to control the catching element 28 on one side to be retracted or released (for example, Fig.42 The operator can select the simultaneous control mode or the separate control mode according to actual needs.

[0137] The above are only the preferred implementation modes of the present application, and are not intended to limit the present application in any form. Although the present application has been disclosed as above in terms of the preferred implementation modes, it is not intended to limit the present application. Any technician familiar with the art can use the methods and technical contents disclosed above to make many possible changes and modifications to the technical solutions of the present application, or modify them into equivalent implementation modes with equivalent changes, without departing from the scope of the technical solutions of the present application. Therefore, any simple modifications, equivalent changes and modifications made to the above implementation modes based on the technical essence of the present application, which do not depart from the contents of the technical solutions of the present application, are still within the scope of protection of the technical solutions of the present application.

Claims

1. A valve clip delivery device for delivering and controlling a valve clip, wherein the valve clip comprises at least two capture elements, It is characterized in that The valve clip delivery device comprises: sheath; and A handle, the handle comprising a housing and at least two control units, at least two capture control lines movably passing through the sheath, the two ends of each capture control line being respectively connected to the corresponding capture element and the control unit; each control unit is provided with a connecting portion, and one of the control units is rotated to force the corresponding connecting portion to switch between being connected to and disconnected from each other relative to at least one of the connecting portions; Wherein, when the connecting parts are connected to each other, at least any one of the control units is moved axially to simultaneously control the retraction or release of the capture elements via the capture control line; when the connecting parts are disconnected from each other, each of the control units is moved axially to individually control the retraction or release of the corresponding capture elements via the capture control line.

2. The valve clip delivery device according to claim 1, It is characterized in that The at least two control units are arranged adjacent to each other and are located on the same side of the central axis of the housing.

3. The valve clip delivery device according to claim 1, It is characterized in that Among the two adjacent control units, one of them is provided with a slot, and the other one of them is protrudingly provided with an insert block, and the insert block can be embedded in the slot.

4. The valve clip delivery device according to claim 3, It is characterized in that The axial dimension of the slot is slightly larger than the axial dimension of the insert block.

5. The valve clip delivery device according to any one of claims 1 to 4, It is characterized in that Each of the control units also includes a fixed sleeve, which is fixedly accommodated in the shell, and at least the distal end of the control unit is movably inserted into the fixed sleeve; a first guide portion and a second guide portion that cooperate with each other are provided between the control unit and the fixed sleeve; wherein one of the first guide portion and the second guide portion is a guide groove extending along the axial direction of the control unit, and the other is a guide protrusion, and the guide protrusion slides axially in the guide groove.

6. The valve clip delivery device according to claim 5, It is characterized in that The guide protrusion is protruding from the control unit, and two guide grooves are arranged in the fixing sleeve; the control unit is rotated to rotate the guide protrusion from one of the guide grooves into the other of the guide grooves.

7. The valve clip delivery device according to claim 6, It is characterized in that The angle between the two guide grooves ranges from 90° to 180°.

8. The valve clip delivery device according to claim 6, It is characterized in that A limiting step is also provided in the fixed sleeve, and the limiting step is located between the two guide grooves; the control unit is rotated to rotate the guide protrusion from one of the guide grooves to be engaged with the limiting step, thereby limiting the axial movement of the control unit toward the distal end.

9. The valve clip delivery device according to any one of claims 1 to 8, It is characterized in that Each of the control units includes a movable rod, an operating member and the capture control line; the capture control line is movably arranged in the sheath, the movable rod and the operating member, the movable rod is movably arranged on the shell, and the operating member is detachably connected to the movable rod to clamp or loosen the capture control line.

10. The valve clip delivery device according to claim 9, It is characterized in that The movable rod comprises a rod body and a cap body, and the connecting portion is arranged along the radial direction of the cap body.

Images