CN116407227A

CN116407227A - Valve repair assembly, valve repair device and valve repair system

Info

Publication number: CN116407227A
Application number: CN202111679353.5A
Authority: CN
Inventors: 王永胜; 任弘; 高国庆; 詹先正; 陈杰
Original assignee: Hangzhou Nuona Biomedical Technology Co ltd
Current assignee: Hangzhou Nuona Biomedical Technology Co ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The application provides a valve repair assembly, a valve repair device and a valve repair system. The valve repair assembly includes an expansion member, a support member, and a cutting member. The expanding member is sleeved outside the cutting member, and the supporting member is provided with a pressing frame. The press frame is provided with a supporting surface. The support surface is for cooperating with the expansion member to clamp the valve. The cutting member is used for cutting a valve clamped between the support surface and the expansion member. The supporting surface is provided with an avoidance part. When the cutting member cuts the valve, the cutting member penetrates through the expanding member and the supporting surface and partially penetrates into the avoiding part, so that the cutting depth of the cutting member to the valve is ensured, the cutting degree of the cutting member to the valve is more sufficient, and the accuracy and the success rate of the operation are improved.

Description

Valve repair assembly, valve repair device and valve repair system

Technical Field

The application relates to the field of medical instruments, in particular to a valve repair assembly, a valve repair device and a valve repair system.

Background

There are four heart valves in the heart that allow blood to flow in a defined direction through the four chambers of the heart. The valve has two or three cusps, petals, or valves that include fibrous tissue attached to the wall of the heart. The cusps open and then close when the blood is flowing properly to form a tight seal to prevent backflow.

The four heart chambers are known as the right and left atria (upper heart chamber) and the right and left ventricles (lower heart chamber). Four valves that control blood flow are known as tricuspid, mitral, pulmonary and aortic valves. In a functioning heart, the tricuspid valve allows unidirectional flow of deoxygenated blood from the upper right heart chamber (right atrium) to the lower right heart chamber (right ventricle). When the right ventricle contracts, the pulmonary valve allows blood to flow from the right ventricle to the pulmonary artery, which delivers deoxygenated blood to the lungs. The mitral valve allows oxygenated blood that has returned to the upper left heart chamber (left atrium) to flow to the lower left heart chamber (left ventricle). When the left ventricle contracts, oxygenated blood is pumped through the aortic valve to the aorta.

Aortic Stenosis (AS) is the most common heart valve disease. Valve replacement is currently the most prominent treatment modality. Valve replacement can be divided into surgical valve replacement (surgical valve replacement, SVR) and transcatheter valve replacement (transcatheter aortic valve replacement, TAVR). Transcatheter aortic valve replacement carries a potential risk of coronary occlusion. Cutting of the valve leaflet can prevent the risk, but the operation process needs multiple operations such as positioning, radio frequency puncture, capturing, traction and the like, and the operation process takes a long time. The valve structure can be softened by cutting calcium on the surface of the valve, so that the valve structure can recover elasticity, and the valve stenosis is relieved. However, the softness of the calcified valve varies, and softer valves are difficult to sever during cutting, affecting the accuracy of the procedure.

Disclosure of Invention

For solving the technical problem, the application provides a valve repair assembly, a valve repair device and a valve repair system, so that the operation accuracy can be improved.

In a first aspect, the present application provides a valve repair assembly comprising an expansion member, a support member and a cutting member, the expansion member being sleeved outside the cutting member, the support member having a press frame with a support surface for cooperating with the expansion member to clamp a valve, the cutting member being for cutting the valve clamped between the support surface and the expansion member; the support surface is provided with an avoidance part; the cutting member passes through the expansion member, the support surface, and partially into the relief as the cutting member cuts the valve.

In a second aspect, the present application provides a valve repair device comprising a valve repair assembly as described above and an operating handle connected to the valve repair assembly.

In a third aspect, the present application provides a valve repair system, including a valve repair device as described above and an outer sheath, the support member and the expansion member being elastically received in the outer sheath, the outer sheath being configured to deliver the support member and the expansion member to a target location, and release the expansion member and the support member at the target location, so as to implement a transition of the expansion member and the support member from a contracted state to an expanded state.

The valve repair assembly, the valve repair device and the valve repair system provided by the application are provided with the avoidance part on the supporting surface, the cutting member penetrates through the bearing surface and the supporting surface and penetrates into the avoidance part when the valve is cut, namely, the cutting member penetrates through the reverse side of the valve from the front side of the valve, so that for softer valves, for example, valves with smaller calcification degrees, the valve repair assembly can ensure the cutting depth of the cutting member to the valve, so that the cutting degree of the cutting member to the valve is more sufficient, and the accuracy and the success rate of operations are improved.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are required to be used in the embodiments will be briefly described below. It is apparent that the figures in the following description are only some of the embodiments provided in this application, and that other figures can be obtained from these figures without inventive effort for a person of ordinary skill in the art.

FIG. 1 is a side view of a valve repair system provided in a first embodiment of the present application;

FIG. 2 is a perspective assembly schematic view of a valve repair assembly with an outer sleeve removed according to a first embodiment of the present application;

FIG. 3 is an exploded perspective view of the valve repair assembly shown in FIG. 2;

FIG. 4 is a further exploded perspective view of the valve repair assembly shown in FIG. 2;

FIG. 5a is a side view of an expansion member of the valve repair assembly shown in FIG. 2;

FIG. 5b is a front view of the extender shown in FIG. 5 a;

FIG. 6 is a schematic perspective view of a press frame of the valve repair assembly shown in FIG. 2;

FIG. 7 is a side view of the valve repair assembly shown in FIG. 2;

FIG. 8a is a perspective assembly schematic view of the valve repair assembly shown in FIG. 2 with the pressure frame removed and the guide head behind the valve repair assembly;

FIG. 8b is another schematic view of the valve repair assembly of FIG. 8 a;

FIG. 8c is another schematic view of the valve repair assembly of FIG. 8 a;

FIG. 9 is a further schematic view of the valve repair assembly of FIG. 2;

FIG. 10 is a rear view of a valve repair assembly including an outer sleeve provided in accordance with a first embodiment of the present application;

FIG. 11 is a side view of an operating handle of the valve repair system shown in FIG. 1;

FIG. 12 is a cross-sectional view of the operating handle shown in FIG. 11 taken along line B-B;

FIG. 13 is a schematic illustration of an aortic valve with calcification and adhesions formed;

FIG. 14 is a schematic view of a cutting blade cutting at calcification of an aortic valve;

FIG. 15 is a schematic view of a cutting blade cutting at an adhesion of an aortic valve;

FIG. 16 is a schematic illustration of the aortic valve after the calcification and adhesion sites have been cut;

FIG. 17 is a perspective assembly schematic view of a valve repair assembly with an outer sleeve removed according to a second embodiment of the present application;

FIG. 18 is a side view of the valve repair assembly of FIG. 17;

FIG. 19 is another schematic view from an angle of view of the valve repair assembly of FIG. 17;

FIG. 20 is an axial cross-sectional view of an operating handle of a valve repair system provided in a second embodiment of the present application;

fig. 21 is a side view of a valve repair assembly provided in a third embodiment of the present application.

Detailed Description

For the purpose of making the objects, technical solutions and advantages of the present application more apparent, the present application will be described in further detail with reference to the accompanying drawings.

It is to be understood that the terms such as "comprises" and "comprising," when used in this application, specify the presence of stated features, operations, or components, and are not to be limited to one or more additional features, operations, or components. In this disclosure, terms such as "comprising" and/or "having" are to be construed as meaning a particular feature, number, operation, constituent element, component, or combination thereof, but are not to be construed as excluding the existence or addition of one or more other features, numbers, operations, constituent elements, components, or combinations thereof.

Furthermore, in this application, the expression "and/or" includes any and all combinations of the words listed in association. For example, the expression "a and/or B" may include a, may include B, or may include both a and B.

In this application, expressions including ordinal numbers such as "first" and "second" and the like may modify each element. However, such elements are not limited by the above expression. For example, the above description does not limit the order and/or importance of the elements. The above description is only intended to distinguish one element from another element. Similarly, a first element could be termed a second element, and, similarly, a second element could be termed a first element, without departing from the scope of the present disclosure.

When a component is referred to as being "connected" or "connected" to another component, it should be understood that: the component is not only directly connected or connected to other components, but there can also be another component between the component and the other components. On the other hand, where components are referred to as being "directly connected" or "directly accessed" to other components, it should be understood that there are no components between them.

In the technical field of interventional medical devices, the position close to the operator is generally defined as the proximal end, and the position far from the operator is defined as the distal end. The direction of the rotation center axis of the column, the tube, or the like is defined as the axial direction. The circumferential direction is the direction (perpendicular to the axis and also perpendicular to the radius of the cross section) around the axis of an object such as a cylinder, a pipe, etc.

Referring to fig. 1, a first embodiment of the present application provides a valve repair system 1000 comprising a valve repair device 1002 and an outer sheath 1004 for delivering the valve repair device 1002. Valve repair device 1002 includes valve repair assembly 101 and operating handle 103. The valve repair assembly 101 is used to repair a valve. The steering handle 103 is coupled to the outer sheath 1004 for steering the valve repair assembly 101.

Referring to fig. 2, 3 and 4, valve repair assembly 101 includes a clamping component and a cutting member 40. The clamping means comprises an expansion member 20 and a support member 30. The expansion member 20 and the support member 30 are adapted to cooperatively clamp the valve to reduce the displacement of the valve due to the forces encountered when the valve is being cut. The cutting member 40 is used to cut the valve held by the expanding member 20 and the support member 30. The expansion member 20, the support member 30 each include a radially contracted state and a radially expanded state.

The expansion member 20, support member 30, and cutting member 40 are disposed through the outer sheath 1004 (shown in fig. 1). When the expansion member 20 and the support member 30 are inserted into the outer sheath 1004, the expansion member 20 and the support member 30 are contracted. The outer sheath 1004 is used to deliver the expansion member 20, the support member 30, and the cutting member 40 to a target location and release the expansion member 20, the support member 30, and the cutting member 40 at the target location to enable the expansion member 20, the support member 30 to be switched from a contracted state to an expanded state. The term "releasing the stent 20, the supporting member 30, and the cutting member 40" means that the stent 20, the supporting member 30, and the cutting member 40 are pushed out of the distal end of the outer sheath 1004 from within the outer sheath 1004, i.e., the stent 20, the supporting member 30, and the cutting member 40 are at least partially outside the outer sheath 1004.

The expansion member 20 includes an expansion element 22 and a first clamping driver 24 coupled to the expansion element 22. The proximal end of the first grip drive 24 is connected to an operating handle 103. The first clamping driver 24 is used to drive the expansion member 22 at least partially in an axial direction.

The material of the expansion member 22 includes, but is not limited to, nickel-titanium alloy, stainless steel or other materials with good elasticity and rigidity. Referring to fig. 5a in combination, the expansion member 22 includes a first mounting portion 222, an expansion portion 224, and a second mounting portion 226 connected in sequence. The first mounting portion 222 is sleeved outside the cutting member 40 and is used for being connected with the supporting member 30. The proximal end of the expansion portion 224 is connected to the first mounting portion 222 and is sleeved outside the cutting member 40. The second mounting portion 226 is coupled to the distal end of the expansion portion 224 and slidably fits over the cutting member 40 for coupling with the first clamping driver 24 to be adjacent to or remote from the first mounting portion 222.

The expansion 224 has a contracted state in which it is contracted in the radial direction and an expanded state in which it is expanded in the radial direction. The contracted state of the expansion member 20 is achieved by the contracted state in which the expansion portion 224 is contracted in the radial direction, and the expanded state of the expansion member 20 is achieved by the expanded state in which the expansion portion 224 is expanded in the radial direction. The expansion 224 is adapted to cooperate with the support member 30 in an expanded state to clamp the valve. In some use scenarios, for example, when the maximum outer diameter of the expansion 224 is greater than or equal to the inner diameter of the vessel, the expansion 224 is also used to bear against the vessel wall in the expanded state to locate the cutting position when the cutting member 40 cuts the valve. When the stent 22 is delivered by the outer sheath 1004, the stent 22 is accommodated in the outer sheath 1004, and the expansion portion 224 of the stent 22 is in a contracted state in which it is contracted in the radial direction. When the expansion portion 224 expands in the radial direction, the axial distance between the first mounting portion 222 and the second mounting portion 226 decreases, i.e., the first mounting portion 222 and the second mounting portion 226 come closer. During radial expansion of the expansion portion 224, the smaller the axial distance between the first mounting portion 222 and the second mounting portion 226, the larger the maximum outer diameter of the expansion portion 224, meaning the larger the degree of expansion.

Referring to fig. 5b, the expansion portion 224 includes three expansion units 2242, a proximal end of each expansion unit 2242 being secured to the first mounting portion 222, and a distal end of each expansion unit 2242 being secured to the second mounting portion 226. All of the expansion units 2242 cooperate to form a bearing surface 2244 for supporting a valve. Each expansion unit 2242 includes at least one axially extending rod, the proximal end of which is fixedly connected to the first mounting portion 222 and the distal end of which is fixedly connected to the second mounting portion 226. During the process of approaching the first mounting portion 222 and the second mounting portion 226, the rod is forced to bend, so that the maximum outer diameter of the expansion portion 224 is gradually increased, that is, the expansion portion 224 is expanded in the radial direction to be in an expanded state. When the rod is not stressed in an axially substantially straight configuration, the expansion 224 is radially contracted to a contracted state.

When the expansion portion 224 is in the expanded state, the expansion portion 224 has a cage-like structure, and the cutting member 40 is accommodated in the expansion portion 224 before passing through the carrying surface 2244, so that the possibility of damage to tissues such as blood vessels due to incorrect manipulation of the cutting member 40 is reduced. When the expansion 224 is expanded radially into a cage configuration, the bearing surface 2244 is positioned at the proximal end of the expansion 224, with the expansion 224 being bounded by approximately the middle of the largest diameter. The cage structure refers to a three-dimensional structure having an inner cavity formed in a three-dimensional space by at least three rods.

It is understood that in other embodiments of the present application, the bearing surface 2244 may also be located on the first mounting portion 222 and/or the expansion portion 224.

It is understood that in other embodiments of the present application, the first mounting portion 222 and the second mounting portion 226 may be omitted.

Referring to fig. 2, 3 and 4, the supporting member 30 includes a pressing frame 32, a conveying member 34 fixedly connected to the pressing frame 32, and a second clamping driving member 36 fixedly connected to the conveying member 34. The press frame 32 is fixedly coupled to the proximal end of the first mounting portion 222. The proximal end of the second clamping driver 36 is connected to an operating handle 103. The second clamping driving member 36 is configured to move the conveying member 34, the pressing frame 32, and the first mounting portion 222 in an axial direction. The second clamping driver 36 and the first clamping driver 24 are independently arranged to facilitate adjusting the force with which the stent member 20 and the support member 30 clamp the valve, preventing the clamping force on the valve from being too great or too small.

Referring to fig. 6 and 7 in combination, the press frame 32 includes a support surface 322 for cooperating with a bearing surface 2244 to hold a valve. The support surface 322 is provided with a relief portion 3222 (as shown in fig. 2 and 6). As cutting member 40 cuts the valve, referring to fig. 7, 8a, 8b and 8c, cutting member 40 passes through bearing surface 2244, support surface 322 and partially into relief 3222.

Because of the varying degrees of softness of the calcified valve, a valve with a greater degree of calcification is stiffer, while a valve with a lesser degree of calcification is softer, which is often difficult to achieve at the desired depth of cut.

In the valve repair assembly 101 provided by the application, the support surface 322 is provided with the avoidance portion 3222, the cutting member 40 penetrates through the bearing surface 2244 and the support surface 322 and penetrates into the avoidance portion 3222 when the valve is cut, namely, the cutting member 40 penetrates through the back surface of the valve from the front surface of the valve, so that for softer valves, for example, the valve with smaller calcification degree, the valve repair assembly 101 can ensure the cutting depth of the cutting member 40 to the valve, so that the cutting degree of the cutting member 40 to the valve is more sufficient, and the accuracy and the success rate of the operation are improved.

Also, the valve is clamped between the bearing surface 2244 and the support surface 322, reducing the likelihood of the valve being displaced during cutting by the cutting member 40, thereby improving the positional stability of the valve during cutting, and facilitating improved surgical accuracy.

In some embodiments, the width design of the relief 3222 may be adapted to the width of the cutting member 40 such that during penetration of the cutting member 40 into the relief 3222, the sidewall of the relief 3222 contacts the cutting member 40 to limit or guide the cutting member 40, improving the cutting stability of the cutting member 40 and making it easier for the cutting member 40 to puncture the valve.

In this embodiment, the press frame 32 further includes a mounting surface 324 (shown in fig. 7) disposed opposite the support surface 322. The support surface 322 is located on the distal side of the press frame 32, the mounting surface 324 is located on the proximal side of the press frame 32, and the relief portion 3222 is a passage penetrating the support surface 322 and the mounting surface 324. The partial cutting member 40 can pass from the support surface 322 into the relief 3222 and out of the mounting surface 324 to further enhance the degree of cutting of the valve by the cutting member 40.

It is understood that in other embodiments of the present application, the relief portion 3222 may also be a blind slot provided in the support surface 322, i.e., the cutting member 40 extends partially from the support surface 322 into the relief portion 3222 but does not expose the mounting surface 324. When the cutting member 40 enters the escape portion 3222 of the blind groove type and abuts against the side wall of the escape portion 3222, the pressing frame 32 is elastically deformed to protect the cutting member 40 and prevent the cutting member 40 from scratching the blood vessel wall.

In other embodiments of the present application, the structure of the pressure frame 32 is not limited, and for example, the pressure frame 22 may be plate-shaped, and the pressure frame 32 may have a supporting surface 322 that cooperates with the expansion element 22 to clamp or support the valve.

Referring to fig. 4, the cutting member 40 includes a cutting unit 42 and a cutting drive 44 coupled to the cutting unit 42.

The cutting unit 42 has an open state and a closed state. The cutting unit 42 has a cutting blade 424 for cutting the valve. The cutting unit 42 expands radially when in the open state, with the cutting blades 424 deployed radially of the cutting unit 42 to be able to pass through the carrying surface 2244, the cutting unit 42 having a maximum open outer diameter. During radial expansion of the cutting unit 42, the outer diameter of the opening of the cutting unit 42 can be gradually increased up to a maximum value of the maximum outer diameter of the opening. The cutting unit 42 is radially contracted when in the closed state, the cutting blade 424 is disposed substantially axially, and the cutting blade 424 does not expose the carrying surface 2244.

The proximal end of the cutting drive 44 is connected to an operating handle 103. The cutting drive 44 is used to drive the cutting unit 42 to radially contract or radially expand to switch between an open state and a closed state. The operation of the cutting unit 42 to switch between the open state and the closed state may be referred to as an open-close operation.

When the expansion 224 is in the contracted state, the cutting unit 42 is in the knife-closing state and the carrying surface 2244 is not exposed. When the expansion portion 224 is in the radially expanded state and has the maximum outer diameter, the cutting unit 42 can be driven by the cutting driving member 44 to switch from the cutting closing state to the cutting opening state and has the maximum cutting opening outer diameter, so that the partial cutting unit 42 can cut the valve through the bearing surface 2244 and the supporting surface 322.

Referring to fig. 4, 8a, 8b and 8c, the cutting unit 42 further includes a cutter holder 422 and a supporting bar 426. The cutting blade 424 is rotatably connected with the tool holder 422, the supporting rod 426 is slidably connected with the tool holder 422 and can rotate relative to the tool holder 422, and the supporting rod 426 is rotatably connected with the cutting blade 424, so that the cutting unit 42 can be switched between an open state and a closed state, namely, the cutting unit 42 can be opened and closed.

The proximal end of the tool holder 422 is fixedly sleeved on the first mounting portion 222, and the tool holder 422 movably penetrates through the expanding portion 224 and the second mounting portion 226. The tool holder 422 has a receiving slot 4222 for carrying a cutting blade 424, a support bar 426, and the like. When the cutter unit 42 is in the closed state, the cutter blade 424 and the support bar 426 are at least partially accommodated in the accommodating groove 4222. The support bar 426 and the cutting blade 424 are exposed from the receiving groove 4222 when the cutting unit 42 is in the opened state.

The cutting blade 424 is used to cut the valve. The cutting blade 424 includes a first coupling portion 4242 and a second coupling portion 4244. The first connecting portion 4242 is rotatably connected to the tool holder 422. The second connection portion 4244 is adapted to be rotatably coupled to the support bar 426.

The support bar 426 includes a sliding end 4262 and a rotating end 4264 that are coupled together. The sliding end 4262 is slidably received in the receiving groove 4222 and is rotatable relative to the tool post 422. The cutting drive 44 is movably disposed through the first mounting portion 222 to be movable relative to the expansion member 22. The slide end 4262 is coupled to the distal end of the cutting drive member 44, and the slide end 4262 is configured to be driven along the housing 4222 by the cutting drive member 44 such that the rotational end 4264 extends out of or is received in the housing 4222. The rotating end 4264 is rotatably connected to the second connecting portion 4244, so as to drive the cutting blade 424 to be received in or extend out of the receiving groove 4222.

When the rotating end 4264 of the cutting blade 424 and the support bar 426 are not exposed to the receiving groove 4222, the cutting unit 42 is contracted in the radial direction, i.e., the cutting unit 42 is in the knife-closed state.

When the cutting blade 424 is supported up by the support bar 426 to protrude out of the receiving groove 4222, the cutting unit 42 is expanded in the radial direction to have the maximum opening outer diameter, i.e., the cutting unit 42 is in the opened state.

The cutting unit 42 also includes a slider 428 that is at least partially slidably received within the pocket 4222. The proximal end of the slide 428 is coupled to the proximal end of the cutting drive 44 to slide along the receptacle 4222 under the drive of the cutting drive 44. The slider 428 is provided with a mounting hole 4282 (shown in fig. 4) in the axial direction. The support bar 426 is at least partially movably received within the mounting hole 4282. The sliding end 4262 is disposed through a sidewall of the mounting hole 4282, such that the support bar 426 is integrally connected with the sliding member 428. The cutting blade 424 movably penetrates through the mounting hole 4282, and the first connecting portion 4242 exposes the mounting hole 4282 to be rotatably connected with the tool holder 422. Movement of the slider 428 from the distal end to the proximal end causes the exposed portion of the cutting blade 424 from the mounting hole 4282 to be enlarged to achieve the open position.

Because the slide end 4262 is integrally connected to the slide 428, the cutting drive 44 drives the slide 426 to move axially, and the slide 426 drives the cutting blade 424 to move axially toward or away from the valve.

When the expanding member 20 and the supporting member 30 clamp the valve, the initial state of the cutting unit 42 may be a knife-engaging state, and the cutting blade 424 may be moved axially along with the slider 428 to a cutting position. The cutting blade 424 is then radially expanded, i.e., the cutting unit 42 is switched from the closed to the open state, and the cutting blade 424 cuts through the bearing surface 2244, the valve, the support surface 322, and the relief 3222.

When the expanding member 20 and the support member 30 clamp the valve, the initial state of the cutting unit 42 may be an open state, and the cutting unit 42 may be moved axially along with the slider 428 to a cutting position. The cutting blade 424 cuts through the bearing surface 2244, the valve, the support surface 322, and the relief 3222.

The tool holder 422 is further provided with a first sliding groove 4224, and the sliding end 4262 rotatably penetrates through the first sliding groove 4224 and is slidably connected with the first sliding groove 4224, so that the supporting rod 426 is slidably connected with the tool holder 422. The distance that the slide 428 slides in the first runner 4224 defines the amount of included angle between the cutting insert 424 and the axial direction of the seat 42. In the present embodiment, the first sliding groove 4224 penetrates through the side wall of the receiving groove 4222 to facilitate the assembly of the sliding end 4262.

In other embodiments of the present application, the first runner 4224 may be omitted, and is directly slidably received in the receiving groove 4222 by the slider 428, so as to realize the sliding connection between the support rod 426 and the tool holder 422.

The tool holder 422 is further provided with a second sliding groove 4226, the sliding member 428 comprises an engaging portion 4284, and the engaging portion 4284 is slidably connected with the second sliding groove 4226, so that smoothness of sliding of the sliding member 428 relative to the tool holder 422 is improved. The first sliding groove 4224 and the second sliding groove 4226 are axially arranged, and the second sliding groove 4226 is disposed at one end of the tool holder 422 near the conveying member 34. For example, the extending directions of the first chute 4224 and the second chute 4226 are all parallel to the axial direction, wherein the extending directions of the first chute 4224 and the second chute 4226 may be on the same straight line, or may be two different parallel straight lines.

In other embodiments of the present application, the first runner 4224 and the second runner 4226 may not be arranged in an axial direction. For example, the extending directions of the first chute 4224 and the second chute 4226 may be acute angles to the axial direction, but the extending directions of the first chute 4224 and the second chute 4226 need to be parallel.

Each of the first connecting portion 4242, the second connecting portion 4244, the sliding end 4262, the rotating end 4264, and the engaging portion 4284 may be a shaft hole or a rotation shaft, and in this embodiment, the first connecting portion 4242, the second connecting portion 4244, the sliding end 4262, and the engaging portion 4284 are rotation shafts, and the rotating end 4264 is a shaft hole.

In other embodiments of the present application, the slider 428 may be located outside of the tool holder 422, with the slider 428 slidably coupled to the tool holder 422.

Referring to fig. 2, 3 and 4, the valve repair assembly 101 further includes a guide head 51 secured to the distal end of the second mounting portion 226 for guiding the expansion member 20, the support member 30 and the cutting member 40 to the valve, wherein the guide head 51 at the distal end of the second mounting portion 226 is operable to slide axially relative to the distal end of the tool holder 422. The first clamping driving member 24 is disposed through the first mounting portion 222, the expanding portion 224, and the second mounting portion 226. The distal end of the first clamping driver 24 is fixed to the guide head 51. The first clamping driver 24 is configured to drive the guide head 51 and the second mounting portion 226 (i.e., the distal end of the spreader 22) toward and away from the first mounting portion 222 (i.e., the proximal end of the spreader 22), so as to radially expand the spreader portion 224 of the spreader 22, thereby allowing the spreader 22 to cooperate with the press frame 32 to clamp the valve.

In other embodiments of the present application, the distal end of the first clamping driver 24 may be secured to the second mounting portion 226 and the guide head 51, or the distal end of the first clamping driver 24 may be secured to the second mounting portion 226.

Referring to fig. 9 and 10, the valve repair assembly 101 further includes a guide 54, where the guide 54 passes through the tool holder 422, the expanding member 22, and the guide head 51 and is exposed outside the guide head 51. The guide 54 is used to thread the traction guide wire. The traction guide wire is used to traction the guide head 51 to guide the whole valve repair assembly 101 to move in the blood vessel.

Valve repair assembly 101 further includes an outer sleeve 55 fixedly attached to delivery member 34. The outer sleeve 55 is disposed through the outer sheath 1004 (shown in FIG. 1). In the present embodiment, the second clamping driving member 36 is slidably sleeved outside the cutting driving member 44, so as to reduce the space occupied by the second clamping driving member 36 and the cutting driving member 44, which is beneficial to miniaturizing the valve repair device 1002.

In one embodiment, the outer sleeve 55 includes a first channel 552, a second channel 554, and a third channel 556. The first clamping driving member 24 movably penetrates through the first cavity 552, the second clamping driving member 36 penetrates through the second cavity 554, the guiding member 54 movably penetrates through the third cavity 556, and the second clamping driving member 36 is slidably sleeved outside the cutting driving member 44, i.e. the first clamping driving member 24, the second clamping driving member 36, the cutting driving member 44 and the guiding member 54 are all carried by the outer sleeve 55. The first clamping drive 24, the second clamping drive 36 and the guide 54 are located in different channels, respectively, so that no interference or influence is exerted on the respective movements.

In other embodiments of the present application, the number of channels in the outer sleeve 55 is not limited, and may be, for example, a single-channel, or a two-channel, and the first clamping driver 24, the second clamping driver 36, the cutting driver 44, and the guide 54 may be inserted into each channel as needed.

Referring to fig. 11 and 12, the operation handle 103 includes a handle body 56, an expansion member operation structure 57, a fixing block 58, and a cutting member operation structure 59. The expansion member operating structure 57 and the cutting member operating structure 59 are movably provided to the handle body 56. The fixed block 58 is fixed within the shank 56. The proximal end of the first clamping driver 24 (i.e., the proximal end of the expansion member 20) is secured to an expansion member operating structure 57, and the expansion member operating structure 57 is configured to drive at least a portion of the expansion member 20 for axial movement. The proximal end of the second clamping driver 36 is secured to a fixed block 58. The proximal end of the cutting drive 44 (i.e., the proximal end of the cutting member 40) is secured to a cutting member operating structure 59, and the cutting member operating structure 59 is used to control the opening and closing motion of the cutting unit 42.

The expansion member operating structure 57 includes an expansion adjustment knob 572 and an expansion traveling block 574. An expansion adjustment knob 572 is provided to the handle body 56. The expansion traveling block 574 is slidably coupled to the shank 56 in the axial direction of the shank 56, and the rotational movement of the expansion traveling block 574 about the axial direction of the shank 56 is restricted, for example, in one possible implementation, a slider is provided on the expansion traveling block 574, a slide groove extending in the axial direction of the shank 56 is provided on the shank 56, and the slider is slidably coupled to the slide groove in the axial direction. Expansion adjustment knob 572 is rotatably coupled to handle body 56 and is internally threaded with expansion traveling block 574. Rotational movement of the expansion adjustment knob 572 relative to the handle body 56 causes axial movement of the expansion traveling block 574. The proximal end of the first clamping driver 24 (the proximal end of the expansion member 20) is secured to the expansion traveling block 574. The axial movement of the expansion traveling block 574 moves the first clamping driver 24 axially with the second mounting portion 226. The expansion moving block 574 and the expansion member 20 are driven to axially move by the rotational movement of the expansion adjustment knob 572, so that the occupied space of the expansion member operating structure 57 is reduced, the miniaturization and the weight reduction of the operating handle 103 are facilitated, and the operation is simple and convenient.

The cutting member operating structure 59 includes a cutting adjustment knob 592 and a cutting movement block 594. A cutting adjustment knob 592 is provided at a proximal end of the shank 56, a cutting block 594 is slidably coupled to the shank 56 in an axial direction of the shank 56, and rotational movement of the cutting block 594 about the axial direction of the shank 56 is limited, for example, in one possible implementation, a slide is provided on the cutting block 594, a slide slot is provided on the shank 56 extending in the axial direction of the shank, and the slide is axially slidably coupled to the slide slot. The cutting adjustment knob 592 is rotatably coupled to the shank 56 and is threadably coupled to the cutting movement block 594. The rotational movement of the cutting adjustment knob 592 relative to the shank 56 causes the cutting movement block 594 to move axially, the proximal end of the cutting drive 44 (the proximal end of the cutting member 40) being secured to the cutting movement block 594, the axial movement of the cutting movement block 594 effecting the opening and closing action of the cutting unit 42 of the cutting member 40. The cutting moving block 594 is driven to axially move by the rotational movement of the cutting adjustment knob 592, which reduces the space occupied by the cutting member operating structure 59, is advantageous for miniaturization and weight reduction of the operating handle 103, and is easy and convenient to operate.

In some embodiments of the present application, the support member 30 may omit the second clamping driver 36 and the securing block 58 may be omitted by adjusting the position of the expansion element 22 relative to the press frame 32.

As shown in fig. 13, calcification 501 forms on the aortic valve 500, or adhesions 502 adhere the valve, resulting in stiffening of the physiology of the aortic valve 500, and the valve 500 does not open or close. For this purpose, a cut is required to be made on calcified valve 500, dividing the original valve into two. Or require cutting at the adhesive 503 to separate the adhered valve.

The following operation steps for repairing a valve in the valve repair system 1000 are briefly described as follows: in operation, a small opening may be made in the femoral artery, from which the sheath 1004 is inserted into the blood vessel and passed along the blood vessel, through the aortic arch, up the aorta, and to the aortic valve. The distal end of the outer sheath 1004 is passed through the aortic arch to the aortic valve site and then the valve repair device 1002 is advanced, and the valve repair device 1002 is released from the outer sheath 1004. The cutting blade 424 cuts at the location of the calcification 501 shown in figure 14, and cutting blade 424 cuts at the location of the adhesive 503 shown in fig. 15, forming a cut valve as shown in fig. 16. After cutting, the valve can resume normal physiological functions.

Referring to fig. 17 and 18, a valve repair assembly 101B is provided in a second embodiment, and the valve repair assembly 101B provided in the second embodiment is similar to the valve repair assembly 101 provided in the first embodiment, except that the expanding member 60 is separated from the supporting member 70, and the supporting member 70 omits a second clamping driver for driving the pressing frame 72 to move axially.

The distal end of the tool holder 822 is fixed on the guide head 91, the second mounting portion 626 of the expansion element 62 (the distal end of the expansion element 62) is a free end, the distal end of the first clamping driving element 64 is fixedly connected with the first mounting portion 622 (the proximal end of the expansion element 62), the first mounting portion 622 is not fixedly connected with the pressing frame 72 and is slidably disposed relatively, and the first clamping driving element 64 is used for driving the expansion element 62 to axially move integrally, and the expansion element 62 can radially expand by its own elastic force.

Since the second mounting portion 626 is a free end, the expansion element 62 automatically expands radially due to its own elastic force when the expansion member 60 is released from the outer sheath, without manipulation, thus simplifying the procedure. The first clamping driving member 64 can drive the expanding member 62 to axially move integrally so as to approach or separate from the pressing frame 72, thereby realizing the purpose of adjusting the clamping force of the expanding member 62 and the pressing frame 72 on the valve. The cutting member 80 is capable of penetrating the support surface 722, the escape portion 7222, and the mounting surface 724 when cutting the valve.

Referring to fig. 19, the first clamping driving member 64 is slidably sleeved outside the cutting driving member 84. The delivery member 74 is fixedly attached to an outer sleeve 95 (shown in fig. 20). The first clamping drive 64, the cutting drive 84 and the guide 94 are disposed through the outer sleeve 95. That is, the first clamping driver 64, the cutting driver 84, and the guide 94 are inserted into the outer sleeve 55. Since the support member 70 omits the second clamping driver, it is advantageous to simplify the structure of the valve repair assembly 101B and reduce the volume of the valve repair assembly 101B.

In other embodiments of the present application, the support member 70 may also include a second clamping drive for driving the axial movement of the press frame 72. Since the expansion member 62 is independently controlled by the first clamping driving member 64 and the pressure frame 72 is independently controlled by the second clamping driving member, the control flexibility of the valve repair device 101B is improved, thereby facilitating adjustment of the clamping force of the expansion member 62 and the pressure frame 72 for clamping the valve.

In other embodiments of the present application, the valve repair assembly 101B further includes a third clamping drive coupled to the second mounting portion 626 and/or the expansion portion 624 for driving the second mounting portion 626 away from or toward the first mounting portion 622 to adjust the expanded outer diameter of the expansion portion 624 when radially expanded.

Referring to fig. 21, a third embodiment of the present application provides a valve repair assembly 101C, and the valve repair assembly 101C provided by the second embodiment is similar to the valve repair assembly 101B provided by the second embodiment in that the support member 70 further includes a blade protection sheet 76 for protecting the cutting blade 824 and reducing the likelihood of the cutting blade 824 scratching a blood vessel or other tissue. The blade protector 76 includes a fixed portion 762 and a free portion 764 that are connected to each other. The fixing portion 762 is fixed to the press frame 72. In the present embodiment, the fixing portion 762 may be fixedly coupled to the proximal end of the press frame 72. In other embodiments of the present application, the securing portion 762 may also be secured to other portions of the press frame 72 or the transport 74. The free portion 764 is movably covered on the mounting surface 724. The free portion 764 can be held against and separated from the mounting surface 724 by a cutting blade 824 that protrudes from the mounting surface 724.

The blade guard 76 is a resilient metal sheet, and the free portion 764 abuts the mounting surface 724 when the cutting blade 824 passes through the relief portion but does not pass out of the mounting surface 724. The free portion 764 is elastically deformed by abutting against the cutting blade 824 when the cutting blade 824 penetrates into the relief portion and out of the mounting surface 724, thereby separating the free portion 764 from the mounting surface 724. The cutting blade 824 may cut the valve because the free portion 764 is separated from the mounting surface 724 after the cutting blade 824 passes through the relief portion, and the blade guard 76 also prevents the cutting blade 824 (e.g., the tip of the cutting blade 824) from cutting the inner wall of a blood vessel or other tissue. For example, when the cutting blade 824 is not required to perform cutting, the cutting blade 824 can reduce the possibility that the cutting blade 824 will scratch the tissue of the inner wall of the blood vessel due to the blocking action of the blade guard 76 when the cutting member 80 is abnormal to cause the cutting unit to be opened in the radial direction and pass through the mounting surface 724. In addition, when the cutting blade 824 needs to cut the valve, the cutting blade 824 penetrates the bearing surface 6244, the valve, the supporting surface 722, the avoiding portion, and the mounting surface 724 to finally abut against the blade protecting sheet 76, and the blade protecting sheet 76 can support the cutting blade 824 like an anvil plate, so that the cutting effect is improved.

In some embodiments, the cutting blade 824 abuts the blade guard 76 and elastically deforms the morphology of the blade guard 76, which may be used to facilitate a determination of whether the blade guard 76 has completed cutting the valve by observing the morphology of the blade guard 76.

The foregoing is a partial embodiment of the present application and it should be noted that, for a person skilled in the art, several improvements and modifications can be made without departing from the principle of the present application, and these improvements and modifications are also considered as the protection scope of the present application.

Claims

1. A valve repair assembly comprising an expansion member, a support member and a cutting member, wherein the expansion member is sleeved outside the cutting member, the support member is provided with a pressing frame, the pressing frame is provided with a support surface, the support surface is used for being matched with the expansion member to clamp a valve, and the cutting member is used for cutting the valve clamped between the support surface and the expansion member; the support surface is provided with an avoidance part; the cutting member passes through the expansion member, the support surface, and partially into the relief as the cutting member cuts the valve.

2. The valve repair assembly of claim 1, wherein a sidewall of the relief contacts the cutting member during penetration of the cutting member into the relief to limit or guide the cutting member.

3. The valve repair assembly of claim 1, wherein the press frame further comprises a mounting surface disposed opposite the support surface, the relief being a channel extending through the support surface and the mounting surface, a portion of the cutting member being capable of passing from the support surface into the relief and out of the mounting surface.

4. The valve repair assembly of claim 3, wherein the support member further comprises a blade protection sheet comprising a fixed portion and a free portion, the fixed portion being secured to the press frame, the free portion being movably covered on the mounting surface, the free portion being capable of being held against and separated from the mounting surface by the cutting member extending from the mounting surface.

5. The valve repair assembly of claim 4, wherein the blade guard is a resilient sheet metal, the free portion abutting the mounting surface when the cutting member penetrates the relief portion but does not penetrate the mounting surface, the free portion elastically deforming with the cutting member when the cutting member penetrates the relief portion and penetrates the mounting surface.

6. The valve repair assembly of claim 1, wherein the press frame further comprises a mounting surface disposed opposite the support surface, the relief being a blind slot extending through the support surface but not through the mounting surface.

7. The valve repair assembly of claim 1, wherein the cutting member comprises a knife holder, a slider, a support bar, a cutting blade, and a cutting drive; the distal end of the expansion member is sleeved outside the tool apron in a sliding manner; the tool apron is provided with an accommodating groove, and the sliding piece is accommodated in the accommodating groove in a sliding manner; the support rod is rotatably connected with the sliding piece so as to be accommodated in or extend out of the accommodating groove; the cutting blade is rotationally connected with the supporting rod and is rotationally connected with the tool apron so as to be accommodated in or extend out of the accommodating groove; the proximal end of the cutting driving piece is fixedly connected with the sliding piece and used for driving the sliding piece to move along the accommodating groove, so that the supporting rod and the cutting blade extend out of the accommodating groove, and the part of the cutting blade extends into the avoiding part from the supporting surface.

8. The valve repair assembly of claim 7, wherein the cutting member has a closed state and an open state, the support bar and the cutting blade being received in the receiving slot when the cutting member is in the closed state; when the cutting member is in the open state, the supporting rod and the cutting blade are exposed out of the accommodating groove;

The state of the cutting member can be switched between the cutting state and the opening state by the movement of the slider along the accommodating groove.

9. The valve repair assembly of claim 8, wherein the tool holder is further provided with a first axially extending runner in communication with the receiving slot, the slider being slidably coupled to the first runner, the distance the slider slides in the first runner defining the amount of included angle between the cutting blade and the tool holder in the axial direction.

10. The valve repair assembly of claim 9, wherein the tool holder is further provided with a second axially extending runner, the first runner being axially aligned with the second runner; compared with the first sliding groove, the second sliding groove is positioned at the proximal end of the sliding piece, the sliding piece is in sliding connection with the first sliding groove, and the sliding piece is in sliding connection with the second sliding groove.

11. The valve repair assembly of claim 8, wherein the slider has a mounting hole, the support rod being movably received in the mounting hole, the cutting blade being movably received in the mounting hole; movement of the slider from the distal end to the proximal end enables the cutting blade to be exposed from the mounting hole.

12. The valve repair assembly of claim 7, wherein the support member further comprises a delivery member fixedly connected to the press frame; the valve repair assembly further comprises a guide head, the expansion member comprises an expansion piece and a first clamping driving piece, the distal end of the expansion piece is sleeved outside the tool apron in a sliding manner, and the distal end of the expansion piece is fixed on the guide head; the proximal end of the knife holder is fixed on the conveying member, and the proximal end of the expanding member is fixed on the conveying member; the first clamping driving piece is arranged on the tool apron in a penetrating mode and the expansion piece in a penetrating mode, the proximal end of the first clamping driving piece is fixed at the distal end of the guide head or the distal end of the expansion piece, and the first clamping driving piece is used for driving the guide head and the distal end of the expansion piece to be close to or far away from the proximal end of the expansion piece so as to realize radial expansion of the expansion piece, so that the expansion piece and the pressing frame are matched to clamp the valve.

13. The valve repair assembly of claim 12, further comprising a second clamp drive member disposed independently of the first clamp drive member, the second clamp drive member slidably disposed over the cutting drive member, a distal end of the second clamp drive member fixedly coupled to the delivery member, the second clamp drive member configured to drive movement of the delivery member.

14. The valve repair assembly of claim 7, further comprising a guide head, wherein the distal end of the holder is secured to the guide head, wherein the expansion member further comprises an expansion element having a free distal end slidably received over the holder, and a first clamping driver fixedly coupled to the proximal end of the expansion element, wherein the first clamping driver is configured to drive the expansion element for axial movement, and wherein the expansion element is radially expandable by its own elastic force.

15. The valve repair assembly of claim 12 or 14, further comprising a guide member threaded through the tool holder, the spreader, the guide head and exposed from the guide head, the guide member being configured to thread a traction wire configured to pull the guide head.

16. A valve repair device comprising a valve repair assembly according to any one of claims 1-15 and an operating handle connected to the valve repair assembly.

17. The valve repair device of claim 16, wherein the operating handle comprises a handle body and a cutting member operating structure movably disposed on the handle body, the proximal end of the cutting member being secured to the cutting member operating structure, the cutting member operating structure being configured to control the opening and closing of the cutting member.

18. The valve repair device of claim 17, wherein the cutting member operating structure comprises a cutting adjustment knob and a cutting movement block, the cutting adjustment knob is disposed at a proximal end of the handle body, the cutting movement block is slidably coupled to the handle body along an axial direction of the handle body, the cutting adjustment knob is rotatably coupled to the handle body and is threadably coupled to the cutting movement block, rotational movement of the cutting adjustment knob relative to the handle body causes axial movement of the cutting movement block, the proximal end of the cutting member is secured to the cutting movement block, and axial movement of the cutting movement block causes the cutting member to open and close.

19. The valve repair device of claim 17, wherein the operating handle further comprises an expansion member operating structure movably disposed on the handle body, the proximal end of the expansion member being secured to the expansion member operating structure, the expansion member operating structure for driving the expansion member at least partially in axial movement.

20. The valve repair device of claim 19, wherein the expansion member operating structure comprises an expansion adjustment knob and an expansion moving block, the expansion adjustment knob being disposed on the handle body, the expansion moving block being slidably coupled to the handle body along an axial direction of the handle body, the expansion adjustment knob being rotatably coupled to the handle body and threadably coupled to the expansion moving block, rotational movement of the expansion adjustment knob relative to the handle body effecting axial movement of the expansion moving block, a proximal end of the expansion member being secured to the expansion moving block, the axial movement of the expansion moving block effecting at least a portion of the axial movement of the expansion member.

21. A valve repair system comprising the valve repair device of any one of claims 16-20 and an outer sheath, the support member and the expansion member being resiliently received within the outer sheath, the outer sheath being configured to deliver the support member and the expansion member to a target location and release the expansion member and the support member at the target location to effect transition of the expansion member and the support member from a contracted state to an expanded state.