WO2022257600A1 - 一种瓣膜夹合系统 - Google Patents

一种瓣膜夹合系统 Download PDF

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Publication number
WO2022257600A1
WO2022257600A1 PCT/CN2022/087004 CN2022087004W WO2022257600A1 WO 2022257600 A1 WO2022257600 A1 WO 2022257600A1 CN 2022087004 W CN2022087004 W CN 2022087004W WO 2022257600 A1 WO2022257600 A1 WO 2022257600A1
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WO
WIPO (PCT)
Prior art keywords
piece
fixing piece
push rod
clip
base body
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2022/087004
Other languages
English (en)
French (fr)
Inventor
王森
宋睿
王智琛
戴志豪
黄中嵘
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Shenqi Medical Technology Co Ltd
Original Assignee
Shanghai Shenqi Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Shenqi Medical Technology Co Ltd filed Critical Shanghai Shenqi Medical Technology Co Ltd
Priority to EP22819203.5A priority Critical patent/EP4353191A4/en
Publication of WO2022257600A1 publication Critical patent/WO2022257600A1/zh
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters

Definitions

  • the present application relates to the field of medical devices, in particular to a valve clipping system.
  • the tricuspid valve is located in the opening between the right atrium and right ventricle.
  • the tricuspid valve opens to allow blood from the right atrium to fill the right ventricle, and when the right ventricle contracts to pump blood into the lungs, the tricuspid valve closes to prevent blood from flowing back into the right atrium.
  • the tricuspid valve does not close completely, some blood leaks through the tricuspid valve back into the right atrium each time the right ventricle contracts, known as tricuspid regurgitation.
  • the current valve interventional therapy technology is based on the principle of edge-to-edge surgery to deliver the valve clip to the target tricuspid valve, and simultaneously clamp the leaflets of the tricuspid valve through the relative opening of the clips, so that the leaflets of the tricuspid valve are relatively fixed. Thereby reducing the gap between the valve leaflets and reducing tricuspid regurgitation.
  • the tricuspid valve Compared with the mitral valve, the tricuspid valve has a larger valve ring and valve area, with the largest variability, the valve ring tissue is more fragile, and the valve leaflets and chordae are thinner; the adjacent structure is complex, and it is easy to cause damage to the surrounding tissue; the valve ring It is half-moon saddle-shaped, irregular in shape and most likely to expand, and the degree of tricuspid regurgitation is most likely to be affected by volume load; in addition, there are abundant muscle trabeculae, meat columns and tendon chords in the right ventricle, and the free wall is weak; and the right ventricle The low blood flow rate is easy to form thrombus, which poses a great challenge to the design and application of surgical instruments. Therefore, there is an urgent need for a valve clipping system that can effectively control the expansion and contraction of the clips and reduce the difficulty and risk of surgery.
  • valve clipping system which can effectively control the expansion and contraction of clips, and reduce the difficulty and risk of surgery.
  • a valve clipping system comprising: an adjustment mechanism, including a proximal clip, a distal clip, a central seat and a base body, the proximal clip is connected to the central seat, and the distal clips are respectively Connected to the central seat body and the base body, the central seat body has an accommodating cavity, and the side wall of the central seat body is provided with through holes;
  • the locking mechanism includes a fixed piece A, a fixed piece B, The push rod and the control member, the fixed piece A and the fixed piece B are arranged in the accommodating cavity against each other, the push rod is located in the accommodating cavity, and passes through the fixed piece A and the fixed piece B
  • the fixing piece B is connected to the base body, the control member can pass through the piercing hole, and bypass the fixing piece A and the fixing piece B from either side of the push rod;
  • the control member and the fixing piece B are jointly configured to adjust the position of the fixing piece A in the accommodating cavity, and when the fixing piece A is in the first position, the pushing rod and the fixing piece A is relatively fixed, and when the fixing piece A is not in the first position, the pushing rod and the fixing piece A move relatively.
  • a stop protrusion is provided on the inner wall of the accommodating cavity, the fixing piece A and the fixing piece B are elastic pieces, and the fixing piece B is configured to make the fixing piece A lean against the stop protrusion, and not in the first position, the control member bypasses the fixed piece A and the fixed piece B from the side of the push rod close to the stop protrusion, and pulls the The control member can make the fixing piece A in the first position.
  • control member is a metal wire or a polymer wire
  • control member extends along the axial direction of the push rod, and the control member can be moved from the side of the push rod close to the stopper protrusion.
  • the fixing piece A and the fixing piece B are bypassed, and the fixing piece A is only connected to the control member at one end close to the stop protrusion.
  • a stop protrusion is provided on the inner wall of the accommodating cavity
  • the fixed piece B is an elastic piece
  • the fixed piece B is configured to make the fixed piece A abut against the stop protrusion, and is located at In the first position, the control piece bypasses the fixing piece A and the fixing piece B from the side of the push rod away from the stopper protrusion, and pulling the control piece can make the fixing piece Slice A is not at the first position.
  • the fixed piece A has a leg A, and the leg A is clamped on the outer wall of the central seat body;
  • the fixed piece B has a leg B, and the leg B is clamped on the central seat body on the outer wall.
  • the surface roughness of the push rod and the surface roughness of the abutting portion of the fixing piece A and the push rod are both greater than or equal to 1.6 ⁇ m.
  • a flow blocking film is provided on the proximal clip and/or the distal clip.
  • the central base body is also provided with a mounting portion, and one end of the distal clip is rotatably connected to the central base body through the mounting portion.
  • the base body includes a connecting rod and a base, the part of the distal clip not connected to the central base body is rotatably connected to the connecting rod, and the push rod is connected to the base.
  • the adjusting mechanism further includes a pulling wire connected to the proximal clip, and the pulling wire is configured to make the part of the proximal clip not abutting against the central seat approach or move away from the center seat.
  • the adjustment mechanism further includes a push-pull wire connected to the push rod, and the push-pull wire is configured to enable the push rod to move in the accommodating cavity.
  • valve clamping system further includes a delivery mechanism for delivering the adjustment mechanism and the locking mechanism to the target position, the delivery mechanism is provided with a fixing piece at one end close to the operator, and the fixing piece configured to detachably connect the control.
  • proximal clip is an elastic clip; the proximal clip is clamped and arranged on the central seat; the distal clip is rotatably connected to the central seat and the base body, to approach or move away from the proximal clip.
  • the proximal clip has elasticity and is connected to the central seat, the distal clip is rotatably connected to the central seat and the base to approach or stay away from the proximal clip, and the distal clip and the proximal
  • the cooperation of the end clips can realize the clamping of the tricuspid valve;
  • the central base has a receiving cavity, and the fixed piece A and the fixed piece B are locked in the receiving cavity against each other, and the push rod is located in the receiving cavity and passes through the receiving cavity.
  • the fixed piece A and the fixed piece B are connected to the base body, and the control piece bypasses the fixed piece A and the fixed piece B from either side of the push rod, and the control piece and the fixed piece B can adjust the position of the fixed piece A in the accommodating cavity. Adjusting the position of the fixing piece A can realize the relative fixing of the push rod and the fixing piece A, that is, the locking of the position of the distal clip, which can ensure the stable clamping of the tricuspid valve by the distal clip and the proximal clip.
  • the valve clamping system is simple and convenient to operate, reduces the difficulty of clamping, reduces the difficulty of the operation for the operator, and reduces the risk of the operation for the patient.
  • FIG. 1 is a schematic structural view of a valve clamping system provided in Embodiment 1 of the present application;
  • Fig. 2 is a schematic diagram of the assembly of the fixed piece and the center seat body provided by Embodiment 1 of the present application;
  • Fig. 3 is a schematic structural view of the locking mechanism provided in Embodiment 1 of the present application in a locked state;
  • Fig. 4 is a schematic structural view of the locking mechanism provided in Embodiment 1 of the present application in an unlocked state
  • Fig. 5 is a schematic structural view of the locking mechanism provided in Embodiment 2 of the present application in a locked state
  • Fig. 6 is a schematic structural diagram of the locking mechanism provided in Embodiment 2 of the present application in an unlocked state.
  • connection should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components.
  • connection can be a fixed connection, a detachable connection, or an integrated ; It can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediary, and it can be the internal communication of two components or the interaction relationship between two components.
  • a first feature being “on” or “under” a second feature may include direct contact between the first and second features, and may also include the first and second features Not in direct contact but through another characteristic contact between them.
  • the first feature being "above”, “above” and “above” the second feature includes that the first feature is directly above and obliquely above the second feature, or simply means that the first feature is horizontally higher than the second feature.
  • "Below”, “beneath” and “under” the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or simply means that the first feature has a lower level than the second feature.
  • the present embodiment provides a valve clamping system, including an adjustment mechanism and a locking mechanism.
  • the adjustment mechanism includes a proximal clip 1, a distal clip 2, a central seat body 3 and a base body, the proximal clip 1 is snapped to the central seat body 3, and the distal clip 2 is connected to the central seat body 3 and the base
  • the central seat body 3 has a receiving cavity, and the side wall of the central seat body 3 is provided with through holes.
  • the locking mechanism includes a fixed piece A6, a fixed piece B7, a push rod 8 and a control member 9.
  • the fixed piece A6 and the fixed piece B7 are arranged in the accommodating cavity against each other, and the push rod 8 is located in the accommodating cavity and passes through the fixed piece A6 and the control piece 9.
  • the fixing piece B7 is connected to the base body, and the control member 9 can pass through the piercing hole, and bypass the fixing piece A6 and the fixing piece B7 from either side of the push rod 8 .
  • the control piece 9 and the fixed piece B7 can adjust the position of the fixed piece A6 in the accommodating cavity.
  • the clamping of the tricuspid valve can be realized. Specifically, when the valve clamping system is delivered to the designated position, the distal clip 2 and the proximal The clips 1 are all in the folded state, and when they are delivered to the designated position, in order to realize the clamping of the tricuspid valve, the distal clip 2 and the proximal clip 1 need to be in the unfolded state, so that a valve leaflet It can be fixed between the distal clip 2 and the proximal clip 1 on one side, while the other leaflet can be fixed between the distal clip 2 and the proximal clip 1 on the other side, so that Subsequent sutures to opposing leaflets.
  • connection between the proximal clip 1 and the central seat body 3, and the connection between the distal clip 2 and the central seat body 3 and the base body can be snap-fit connection, screw connection, rivet connection, adhesive connection, etc.
  • Fixed or rotating or detachable connection methods are not limited here, and can be flexibly adjusted and set according to actual needs.
  • the proximal clip 1 is an elastic clip.
  • the distal clip 1 is rotatably connected to the central base body 3 and the base body so as to approach or move away from the proximal clip 1 .
  • the proximal clip 1 is ⁇ -shaped, and an assembly part can be formed inside it, so that the proximal clip 1 and the center seat body 3 can be fitted through an interference fit, so that the assembly part of the proximal clip 1 and the center seat
  • the body 3 is relatively fixed, and the two branches of the proximal clip 1 away from the central seat body 3 are elastic, so that the branch can be in an unfolded state when no external force is applied, and can be in a folded state when subjected to an external force.
  • the folding and unfolding of the distal clip 2 is controlled by a push rod 8, and a through hole is provided inside the center base body 3 in a direction parallel to its side wall, and the through hole communicates with the receiving chamber, and the push rod 8 penetrates the In the through hole, the control of the distal clip 2 is realized by the movement of the push rod 8 in the through hole.
  • the central base body 3 of the valve clamping system provided in this embodiment is further provided with a mounting portion 32 , and one end of the distal clip 2 is rotatably connected to the central base body 3 through the mounting portion 32 .
  • the mounting part 32 is a circular protrusion provided on the opposite outer wall of the central seat body 3, and the distal clip 2 is provided with a mounting hole so that the circular protrusion can pass through the mounting hole Inside.
  • the mounting part 32 is a pin or a fixed rod that passes through the central base body 3, and it is fixed to the central base body 3 by welding or screwing, and similar to the aforementioned circular protrusion, it can also pass through the far into the mounting hole on end clip 2.
  • the base body includes a connecting rod 5 and a base 4 , the part of the distal clip 2 not connected to the central base body 3 is rotatably connected to the connecting rod 5 , and the push rod 8 is connected to the base 4 .
  • a stop protrusion 31 is provided on the inner wall of the accommodating cavity, the fixed piece A6 and the fixed piece B7 are both elastic pieces, and the fixed piece B7 is used to make the fixed piece A6 leans against the stop protrusion 31, and is not in the first position, the control piece 9 walks around the fixed piece A6 and the fixed piece B7 from the side of the push rod 8 close to the stop protrusion 31, and pulling the control piece 9 can make The fixing piece A6 is located at the first position.
  • control member 9 is arranged on the left side of the push rod 8, and bypasses the fixed piece A6 and the fixed piece B7, wherein the fixed piece B7 is arranged above the fixed piece A6, and between the two The forces between them are balanced so that they can be placed against each other in the accommodating cavity.
  • control member 9 is a wire made of stainless steel, aluminum alloy, etc., or a polymer wire with a certain rigidity.
  • the metal wire or polymer wire extends along the axial direction of the push rod, and the fixing piece A is only connected to the control member at one end close to the stopper protrusion.
  • the fixed piece A6 is subjected to gravity and the elastic force exerted by the fixed piece B7, and can be placed horizontally in the accommodating cavity. A6 moves.
  • the fixed piece A6 is not limited to be placed horizontally in the accommodating cavity, but only needs to ensure that the fixed piece A6 is not in the first position when it is not affected by the force of the control member 9 .
  • the control member 9 is tightened so that the fixing piece A6 is located at the first position, the push rod 8 will be blocked by the fixing piece A6 at this time.
  • the central seat body 3, the fixed piece A6 and the fixed piece B7 are all provided with round holes, and when the fixed piece A6 is in the first position, the projected area of the round hole on the fixed piece A6 in the horizontal direction is smaller than the transverse direction of the push rod 8.
  • the cross-sectional area is smaller, the push rod 8 will be clamped in the round hole of the fixed piece A6, that is, the relative position between the push rod 8 and the fixed piece A6 is fixed.
  • the control member 9 is loosened, when the fixed piece A6 is not in the first position, the push rod 8 can move through the circular holes of the aforementioned three parts, so that the push rod 8 can move relative to the fixed piece A6. At this time, the position of the distal clip 2 can be adjusted.
  • the fixed piece A6 has a leg A, and the leg A is clamped on the outer wall of the central seat body 3.
  • the fixing piece B7 has a leg B, and the leg B is clamped on the outer side wall of the central base body 3 .
  • the fixed piece B7 is an elastic piece mainly for pressing against the fixed piece A6 so that the fixed piece A6 can be at a preset position. Therefore, in this embodiment, there is no fixed connection between the fixing piece B7 and the central base body 3 .
  • the fixing piece B7 and the inner wall of the accommodating cavity can be fixed by welding, or the fixing piece B7 and the central seat body 3 can be integrally formed.
  • the shapes of the bodies of the fixing piece A6 and the fixing piece B7 include, but are not limited to, rectangle, square or circle.
  • the shape of the fixing piece mainly considers matching with the shape of the receiving cavity, that is, it is necessary to ensure that the fixing piece can abut against the inner side wall of the receiving cavity.
  • the materials of the fixing piece A6 and the fixing piece B7 include but are not limited to metal materials such as nickel-titanium alloy, stainless steel or aluminum alloy.
  • the surface roughness of the push rod 8 and the surface roughness of the abutting portion of the fixing piece A6 and the push rod 8 are both greater than or equal to 1.6 ⁇ m.
  • both the proximal clip 1 and the distal clip 2 are provided with a flow blocking film.
  • the flow blocking film can partially or completely cover the surface of the proximal clip 1 or the distal clip 2, and the flow blocking film can form a friction part on the surface of the clip to increase adhesion.
  • the choke film can quickly endothelialize the clip, and on the one hand, the fast endothelialization can effectively reduce the taking cycle of anticoagulants, shorten the treatment time, reduce the treatment cost, and relieve the pain of patients; on the other hand, it can prevent the formation of device thrombus The risk is reduced and the safety of device-based implantation is improved.
  • the flow blocking film is welded to the proximal clip 1 and the distal clip 2.
  • one or more points on the flow blocking film can be heated with the proximal clip 1 and the distal clip 2. weld.
  • the blocking membrane is bound and fixed with the proximal clip 1 and the distal clip 2 by cotton or polymer silk.
  • the flow blocking film can be made of a polymer film by heating and cutting through a heat-setting mold, or formed by weaving.
  • cotton or polymer filaments are generally used, the diameter of which is 0.01-0.02mm, the number of braiding heads is 2-32 strands, the PPI (braiding density) is 30-100, and the braiding method is n strands. Press it onto m strands, where the values of n and m can be the same or different.
  • a plurality of pores are formed on the flow blocking film, and the shapes of the pores include but are not limited to circles, rectangles, and the like. Specifically, the maximum radius of the pore size is 15-600 ⁇ m, and the pore percentage is 10-90%.
  • the material of the barrier film includes, but is not limited to, polyethylene terephthalate (PET), polyester, polyurethane, expanded polytetrafluoroethylene (ePTFE), cotton, silicon, or various biological phases. Single or combination of capacitive polymers or fibers.
  • PET polyethylene terephthalate
  • ePTFE expanded polytetrafluoroethylene
  • drugs, antibiotics, antithrombotic agents or antiplatelet agents, such as heparin or warfarin sodium can also be added to the choke membrane, and these agents can be impregnated in the choke membrane or coated on the choke membrane , when the clip clamps the leaflet, the drug can be covered on the leaflet or absorbed by the blood.
  • proximal clip 1 and distal clip 2 may be assembled from separate components of biocompatible materials, which may be formed from the same or different materials including, but not limited to, stainless steel, Nitinol, Titanium, tantalum, metal alloys or polymers, or they can be made of biocompatible materials that are absorbed by surrounding tissue or dissolve into the blood after implantation.
  • biocompatible materials including, but not limited to, stainless steel, Nitinol, Titanium, tantalum, metal alloys or polymers, or they can be made of biocompatible materials that are absorbed by surrounding tissue or dissolve into the blood after implantation.
  • the proximal clip 1 and the distal clip 2 are in a closed state, and the control member 9 is in a tensioned state , the fixing piece A6 is located at the first position.
  • the control part 9 can be in a relaxed state, so that the fixed piece A6 is not in the first position, and then the push rod 8 can be moved in the through hole towards the side away from the base 4.
  • the end clip 2 can be unfolded relative to the center seat 3 under the pull of the connecting rod 5 .
  • the far-end clip 2 when the far-end clip 2 is deployed at the lesion position below the valve, it is necessary to release the control of the two branches of the proximal clip 1, and after the two branches of the proximal clip 1 are released, they can move closer to the far side.
  • the direction of the end clip 2 is expanded, and at this time, the distal clip 2 and the proximal clip 1 gradually move closer to clamp the valve leaflet between the two.
  • the control member 9 can be tightened so that the fixing piece A6 is located at the first position, and the relative fixing between the push rod 8 and the fixing piece A6 can be realized, and the distal clamping piece 2 can be locked.
  • the control member 9 can be loosened again so that the fixing piece A6 is not located at the first position, and at this time, the push rod 8 can be restored again. Move, the position of the clip 2 at the far end can be readjusted to prepare for subsequent operations.
  • the adjustment mechanism also includes a pulling wire connected to the proximal clip 1 , and the pulling wire is configured to make the part of the proximal clip 1 not abutting against the central base 3 approach or move away from the central base 3 .
  • the pulling wire is used to control the two branches of the proximal clip 1 so that the proximal clip 1 can switch back and forth between the folded state and the unfolded state.
  • a wire cavity is provided in the two branches of the proximal clip 1, and one end of the pulling wire is arranged in the wire cavity, and the two branches of the proximal clip 1 can be aligned with each other by pulling the other end of the pulling wire. 3 deflection.
  • the adjustment mechanism further includes a push-pull wire connected to the push rod 8, and the push-pull wire is configured to enable the push rod 8 to move in the accommodation chamber.
  • the push-pull wire is fixedly connected to the end of the push rod 8 away from the base 4.
  • the push-pull wire can be manipulated to move the push rod 8 in the through hole, wherein the push-pull wire
  • the fixing method with the push rod 8 can be threaded connection, riveting and the like.
  • valve clamping system further includes a delivery mechanism for delivering the adjustment mechanism and the locking mechanism to the target position, the delivery mechanism is provided with a fixing piece at one end close to the operator, and the fixing piece
  • the control part is configured to be detachably connected to the control part.
  • the detachable connection may be in the form of screw connection, buckle connection, hinge connection and the like.
  • valve clamping system in this embodiment is different from the valve clamping system in Embodiment 1 in that: as shown in Figure 5 and Figure 6, at least the fixing piece B7 It is an elastic piece, and the fixed piece B7 is configured so that the fixed piece A6 abuts against the stop protrusion 31 and is located at the first position, and the control member 9 bypasses the fixed piece A6 and the The piece B7 is fixed, and the control piece 9 is pulled so that the piece A6 is not located at the first position.
  • both the fixed piece B7 and the fixed piece A6 are elastic pieces, but when the fixed piece A6 is subjected to gravity and the elastic force exerted by the fixed piece B7, it is different from that in the first embodiment, as shown in FIG. At 9 o'clock, the fixed piece A6 cannot be placed horizontally in the accommodating cavity, but is pressed against the first position by the fixed piece B7. At this time, the push rod 8 will be blocked by the fixed piece A6, that is, the position of the distal clip 2 will be locked. fixed.
  • the fixed piece A6 when pulling the control member 9, the fixed piece A6 can be subjected to external force and leave the first position, at this moment, the push rod 8 can slide relative to the fixed piece A6, that is, push and pull the push rod 8 to adjust the distal end The unfolded or folded state of clip 2.
  • the fixed piece B7 is an elastic piece, and the fixed piece A6 is located at the first position by gravity and the elastic force exerted by the fixed piece B7. At this time, the push rod 8 is relatively fixed with the fixed piece A6.
  • the fixed piece A6 can also be Under the action of the control member 9, the first position is left, and at this time, the push rod 8 can move relative to the fixed piece A6.
  • the proximal clip 1 and the distal clip 2 are in a retracted state, and the control member 9 is in a relaxed state.
  • the fixing piece A6 is located at the first position.
  • the control part 9 can be in a tensioned state, so that the fixed piece A6 is not located at the first position, and then the push rod 8 can be moved towards the side away from the base 4 in the through hole.
  • the distal clip 2 can be unfolded relative to the center base 3 under the pull of the connecting rod 5 .
  • the control member 9 can be loosened so that the fixing piece A6 is located at the first position, and the relative fixing of the push rod 8 and the fixing piece A6 can be realized, and the distal clamping piece 2 can be locked.
  • the control member 9 can be re-tightened so that the fixing piece A6 is not located at the first position, and at this time, the push rod 8 can be reset again The movement is resumed, and the position of the distal clip 2 can be readjusted to prepare for subsequent operations.
  • the valve clamping system of the present application can be used not only for tricuspid valve clamping, but also for mitral valve clamping.
  • the proximal clip is flexible and snapped to the central seat
  • the distal clip is rotatably connected to the central seat and the base to approach or move away from the proximal clip
  • the distal clip Cooperating with the proximal clip, the clamping of the mitral valve can be realized;
  • the central seat body has a receiving cavity, and the fixed piece A and the fixed piece B are locked in the receiving cavity against each other, and the push rod is located in the receiving cavity and Pass through the fixed piece A and the fixed piece B and connect to the base body, the control piece bypasses the fixed piece A and the fixed piece B from either side of the push rod, the control piece and the fixed piece B can adjust the position of the fixed piece A in the accommodating cavity , by adjusting the position of the fixed piece A, the relative fixation of the push rod and the fixed piece A can be realized, that is, the locking

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Abstract

一种瓣膜夹合系统包括调节机构和锁定机构。调节机构包括近端夹片（1）、远端夹片（2）、中心座体（3）和底座体。近端夹片（1）卡接于中心座体（3），近端夹片（2）转动连接于中心座体（3）和底座体以靠近或远离近端夹片（1）。中心座体（3）具有容纳腔，中心座体（3）侧壁上设有相对的穿设孔。锁定机构包括固定片A（6）、固定片B（7）、推送杆（8）和控制件（9）。固定片A（6）和固定片B（8）相互抵靠的卡设于容纳腔内，推送杆（8）位于容纳腔内，且穿过固定片A（6）和固定片B（7）连接于底座体。控制件（9）和固定片B（7）被共同配置为调整固定片A（6）在容纳腔内的位置。以此实现对瓣叶的稳定夹持，该瓣膜夹合系统操作简单，可降低手术风险。

Description

一种瓣膜夹合系统 技术领域
本申请涉及医疗器械领域，尤其涉及一种瓣膜夹合系统。
背景技术
三尖瓣位于右心房和右心室之间的开口内。三尖瓣开放可使来自右心房的血液充盈右心室，右心室收缩以将血液泵入肺部时，三尖瓣关闭以防止血液流回右心房。当三尖瓣未完全闭合时，部分血液会在右心室每次收缩时通过三尖瓣漏回右心房，称为三尖瓣反流。
近年来三尖瓣反流的经导管介入治疗成为了心脏瓣膜病治疗领域的研究热点和难点。目前瓣膜介入治疗技术是基于缘对缘手术原理将瓣膜夹输送至目标三尖瓣处，通过夹片的相对开合同时夹住三尖瓣的瓣叶，使得三尖瓣的瓣叶相对固定，从而减小瓣叶的间隙，降低三尖瓣的反流。三尖瓣相比二尖瓣拥有更大的瓣环和瓣膜面积，变异性最大，瓣环组织更脆弱，瓣叶和腱索更菲薄；毗邻结构复杂，易产生对周围组织的损伤；瓣环呈半月马鞍形，形状不规则且最容易扩张，三尖瓣反流程度最容易受容量负荷的影响；此外右心室存在丰富的肌小梁、肉柱和腱索、游离壁薄弱；且右心室血液流速低易形成血栓，对手术器械的设计和应用形成了极大的挑战。因此，亟需一种瓣膜夹合系统，可有效控制夹片的展开与收拢，降低手术的难度和风险。
发明内容
有鉴于此，本申请公开一种瓣膜夹合系统，可有效控制夹片的展开与收拢，降低手术的难度和风险。
一种瓣膜夹合系统，包括：调节机构，包括近端夹片、远端夹片、中心座体和底座体，所述近端夹片连接所述中心座体，所述远端夹片分别连接于所述中心座体和所述底座体，所述中心座体具有容纳腔，所述中心座体侧壁上设有贯通的穿设孔；锁定机构，包括固定片A、固定片B、推送杆和控制件，所述固定片A和所述固定片B相互抵靠的设于所述容纳腔内，所述推送杆位于所述容纳腔内，且穿过所述固定片A和所述固定片B连接于所述底座体，所述控制件能够穿过所述穿设孔，且从所述推送杆的任意一侧绕过所述固定片A和所述固定片B；
所述控制件和所述固定片B被共同配置为调整所述固定片A在所述容纳腔内的位置，当所述固定片A位于第一位置时，所述推送杆与所述固定片A相对固定，当所述固定片A不位于第一位置时，所述推送杆与所述固定片A相对移动。
进一步地，所述容纳腔内壁上设有止挡凸起，所述固定片A和所述固定片B均为弹片，所述固定片B被配置为使所述固定片A抵靠于所述止挡凸起，且不位于所述第一位置，所述控制件从所述推送杆靠近所述止挡凸起的一侧绕过所述固定片A和所述固定片B，且拉动所述控制件能够使所述固定片A位于第一位置。
进一步地，所述控制件为金属丝或高分子丝，所述控制件沿所述推送杆的轴向延伸，所述控制件能从所述推送杆的靠近所述止挡凸起的一侧绕过所述固定片A和所述固定片B，并且所述固定片A仅在靠近所述止挡凸起的一端连接所述控制件。
进一步地，所述容纳腔内壁上设有止挡凸起，所述固定片B为弹片，所述固定片B被配置为使所述固定片A抵靠于所述止挡凸起，且位于所述第一位置，所述控制件从所述推送杆远离所述止挡凸起的一侧绕过所述固定片A和所述固定片B，且拉动所述控制件能够使所述固定片A不位于第一位置。
进一步地，所述固定片A具有支脚A，所述支脚A卡设于所述中心座体的外侧壁上；所述固定片B具有支脚B，所述支脚B卡设于所述中心座体的外侧壁上。
进一步地，所述推送杆的表面粗糙度以及所述固定片A与所述推送杆抵接处的表面粗糙度均大于或等于1.6μm。
进一步地，所述近端夹片和/或所述远端夹片上设有阻流膜。
进一步地，所述中心座体上还设有安装部，所述远端夹片的一端通过所述安装部转动连接于所述中心座体。
进一步地，所述底座体包括连杆和底座，所述远端夹片未连接所述中心座体的部分转动连接于所述连杆，所述推送杆连接于所述底座。
进一步地，所述调节机构还包括连接于所述近端夹片的牵引丝，所述牵引丝被配置为使所述近端夹片未抵接所述中心座体的部分靠近或远离所述中心座体。
进一步地，所述调节机构还包括连接于所述推送杆的推拉丝，所述推拉丝被配置为使所述推送杆能够在所述容纳腔内移动。
进一步地，所述瓣膜夹合系统还包括用于将所述调节机构和所述锁定机构输送至目标位置的输送机构，所述输送机构在靠近操作者的一端设置有固定件，所述固定件被配置为可拆卸地连接所述控制件。
进一步地，所述近端夹片为弹性夹片；所述近端夹片卡接设置于所述中心座体；所述远端夹片转动连接于所述中心座体和所述底座体，以靠近或远离所述近端夹片。
本申请提出的瓣膜夹合系统，近端夹片具有弹性且连接中心座体，远端夹片转动连接于中心座体和底座体以靠近或远离近端夹片，通过远端夹片和近端夹片的配合，可以实现对于三尖瓣的夹持；中心座体具有容纳腔，固定片A和固定片B相互抵靠的卡设于容纳腔内，推送杆位于容纳腔内且穿过固定片A和固定片B连接于底座体，控制件从推送杆的任意一侧绕 过固定片A和固定片B，控制件和固定片B能够调整固定片A在容纳腔内的位置，通过调整固定片A的位置，可以实现推送杆与固定片A的相对固定，也即远端夹片位置的锁定，这可确保远端夹片和近端夹片对三尖瓣的稳定夹持。该瓣膜夹合系统操作简单方便，降低了夹持难度，对操作者来说减小了手术的难度，对于患者来说降低了手术的风险。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请的实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据公开的附图获得其他的附图。
图1是本申请实施例一提供的瓣膜夹合系统的结构示意图；
图2是本申请实施例一提供的固定片与中心座体的装配示意图；
图3是本申请实施例一提供的锁定机构在锁定状态下的结构示意图；
图4是本申请实施例一提供的锁定机构在未锁定状态下的结构示意图；
图5是本申请实施例二提供的锁定机构在锁定状态下的结构示意图；
图6是本申请实施例二提供的锁定机构在未锁定状态下的结构示意图。
图中：
1、近端夹片；2、远端夹片；3、中心座体；31、止挡凸起；32、安装部；4、底座；5、连杆；6、固定片A；7、固定片B；8、推送杆；9、控制件。
具体实施方式
为使本申请解决的技术问题、采用的技术方案和达到的技术效果更加清楚，下面结合附图并通过具体实施方式来进一步说明本申请的技术方案。可以理解的是，此处所描述的具体实施例仅仅用于解释本申请，而非对本申请的限定。另外还需要说明的是，为了便于描述，附图中仅示出了与本申请相关的部分而非全部。
在本申请的描述中，除非另有明确的规定和限定，术语“相连”、“连接”、“固定”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或成一体；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
在本申请中，除非另有明确的规定和限定，第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触，也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且，第一特征在第二特征“之上”、“上方”和“上面”包括第一特 征在第二特征正上方和斜上方，或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方，或仅仅表示第一特征水平高度小于第二特征。
在本实施例的描述中，术语“上”、“下”、“左”、“右”等方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化操作，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”仅仅用于在描述上加以区分，并没有特殊的含义。
下面结合附图并通过具体实施方式来进一步说明本申请的技术方案。
实施例一
如图1至图4所示，本实施例提供一种瓣膜夹合系统，包括调节机构和锁定机构。其中调节机构包括近端夹片1、远端夹片2、中心座体3和底座体，近端夹片1卡接于中心座体3，远端夹片2连接于中心座体3和底座体，中心座体3具有容纳腔，中心座体3侧壁上设有贯通的穿设孔。锁定机构包括固定片A6、固定片B7、推送杆8和控制件9，固定片A6和固定片B7相互抵靠的设于容纳腔内，推送杆8位于容纳腔内且穿过固定片A6和固定片B7连接于底座体，控制件9能够穿过穿设孔，且从推送杆8的任意一侧绕过固定片A6和固定片B7。控制件9和固定片B7能够调整固定片A6在容纳腔内的位置，当固定片A6位于第一位置时，推送杆8与固定片A6相对固定，当固定片A6不位于第一位置时，推送杆8与固定片A6相对移动。
通过远端夹片2和近端夹片1的配合，可以实现对三尖瓣的夹持，具体地，当瓣膜夹合系统在被输送至指定的位置之前，远端夹片2和近端夹片1都处于收拢状态，而当被输送至指定的位置后，为实现对三尖瓣的夹持，则需远端夹片2和近端夹片1处于展开状态，从而使得一个瓣叶可被固定于一侧的远端夹片2和近端夹片1之间，而另一个瓣叶可被固定于另一侧的远端夹片2和近端夹片1之间，以便于后续对于相对瓣叶的缝合。
需要说明的是，近端夹片1与中心座体3的连接，以及远端夹片2与中心座体3和底座体的连接可以为卡接连接、螺纹连接、铆钉连接、粘结连接等固定或转动或可拆卸连接方式，在此不进行限定，根据实际需求灵活调整与设置。
在一个具体实施例中，近端夹片1为弹性夹片。此外，远端夹片1转动连接于中心座体3和底座体，以靠近或远离所述近端夹片1。
具体地，而为保证瓣膜夹合系统对于三尖瓣的固定效果，即在利用远端夹片2和近端夹片1对三尖瓣进行夹持时，应保证远端夹片2和近端夹片1的相对位置固定。可选地，近端夹片1为Ω型，其内部可形成装配部，以此近端夹片1与中心座体3通过过盈配合，而使近端夹片1的装配部与中心座体3相对固定，而近端夹片1远离中心座体3的两分支具有弹性，以使该分支在未受外力作用时可处于展开状态，而若受外力作用则可处于收拢状态。可选地， 远端夹片2的收拢和展开由推送杆8控制，中心座体3内部在平行其侧壁方向设有贯通孔，且该贯通孔与容纳腔连通，推送杆8穿设于该贯通孔内，通过推送杆8在贯通孔内的移动以实现对远端夹片2的控制。
具体地，本实施例提供的瓣膜夹合系统的中心座体3上还设有安装部32，远端夹片2的一端通过安装部32转动连接于中心座体3。可选地，安装部32是中心座体3相对的外侧壁上设置的圆形凸起，而远端夹片2上设有安装孔，以使该圆形凸起可穿设于该安装孔内。可选地，安装部32是贯穿中心座体3的插销或者固定杆，其通过焊接或者螺接的方式与中心座体3固定，且与前述圆形凸起类似，其也可穿设于远端夹片2上的安装孔内。
而远端夹片2除一端与中心座体3转动连接外，其余部分还需与底座体转动连接。在本实施例中，底座体包括连杆5和底座4，远端夹片2未连接中心座体3的部分转动连接于连杆5，推送杆8连接于底座4。以此即可实现，推动推送杆8，当底座4远离中心座体3时，远端夹片2逐渐展开，当底座4靠近中心座体3时，远端夹片2逐渐收紧。因此，若需要远端夹片2在某一位置固定，则必须使推送杆8在贯通孔内的相对位置固定。
为实现上述对于远端夹片2的位置固定，本实施例中，容纳腔内壁上设有止挡凸起31，固定片A6和固定片B7均为弹片，固定片B7被用于使固定片A6抵靠于止挡凸起31，且不位于第一位置，控制件9从推送杆8靠近止挡凸起31的一侧绕过固定片A6和固定片B7，且拉动控制件9能够使固定片A6位于第一位置。具体地，如图3和图4所示，控制件9设置于推送杆8的左侧，且绕过固定片A6和固定片B7，其中固定片B7设置于固定片A6上方，且两者之间受力平衡，以使其可以相互抵靠的放置于容纳腔内。可选地，控制件9是不锈钢、铝合金等制成的金属丝，或者是具有一定刚度的高分子丝。可选地，所述金属丝或高分子丝沿所述推送杆的轴向延伸，并且所述固定片A仅在靠近所述止挡凸起的一端连接所述控制件。
本实施例中，固定片A6受重力和固定片B7所施加的弹力作用，可水平放置于容纳腔内，此时，推送杆8穿设于固定片A6和固定片B7内，可相对固定片A6移动。在其他一个实施例中，固定片A6不限于只可水平放置于容纳腔内，而是只要保证固定片A6在不受控制件9的力的作用时，固定片A6不位于第一位置即可。但是，如图3所示，若拉紧控制件9以使固定片A6位于第一位置，则此时推送杆8将被固定片A6卡住。具体地，中心座体3、固定片A6和固定片B7均设有圆孔，当固定片A6位于第一位置时，固定片A6上的圆孔在水平方向的投影面积小于推送杆8的横截面积时，推送杆8将被卡紧于固定片A6的圆孔中，即推送杆8与固定片A6的相对位置固定。但是，如图4所示，若放松控制件9，当固定片A6不位于第一位置时，则推送杆8可穿过前述三个部件的圆孔移动，以实现推送杆8相对固定片A6的移动，此时即可调整远端夹片2的位置。
进一步地，为保证固定片A6和固定片B7在容纳腔内的相对位置，除了需保证固定片A6和固定片B7均为弹片外。可选地，固定片A6具有支脚A，支脚A卡设于中心座体3的 外侧壁上。支脚A设有多个，通过多个支脚A与中心座体3外侧壁的过盈配合，以增大固定片A6与中心座体3之间的摩擦力，使得固定片A6在受外力而改变其位置时，变化更加平稳。可选地，固定片B7具有支脚B，支脚B卡设于中心座体3的外侧壁上。支脚B设有多个，其作用与支脚A类似。
还有要说明的是，固定片B7为弹片主要是为用于抵压固定片A6，以使固定片A6可处于预设位置。因此，本实施例中，固定片B7与中心座体3未设置固定连接。但是，在其他一个实施例中，可以将固定片B7与容置腔内壁通过焊接进行固定，或者，将固定片B7与中心座体3设置为一体成型。可选地，固定片A6和固定片B7的本体的形状包括但不限于是长方形、正方形或圆形。本实施例中，固定片的形状主要考虑与容纳腔的形状的匹配，即需保证固定片可抵接于容纳腔的内侧壁。可选地，固定片A6和固定片B7的材质包括但不限于是镍钛合金、不锈钢或铝合金等金属材料。
更进一步地，在保证推送杆8推送流畅性的同时，还需保证固定片A6与推送杆8相对固定的牢固度，以使远端夹片2和近端夹片1对于瓣叶的夹持更加稳定。本实施例中，推送杆8的表面粗糙度以及固定片A6与推送杆8抵接处的表面粗糙度均大于等于1.6μm。
可选地，近端夹片1和远端夹片2上均设有阻流膜。阻流膜可部分或者完全覆盖于近端夹片1或者远端夹片2的表面，阻流膜可在夹片表面形成摩擦部，增加附着力。具体地，阻流膜可以使夹片快速内皮化，而内皮化快一方面可以有效的降低抗凝药的服用周期，缩短治疗时间，降低治疗费用，减轻患者痛苦，另一方面使形成器械血栓的风险降低，提高了基于器械植入的安全性。可选地，阻流膜与近端夹片1、远端夹片2焊接固定，具体地，可将阻流膜上一个或多个点与近端夹片1、远端夹片2进行热焊。可选地，阻流膜与近端夹片1、远端夹片2通过棉质或聚合物丝捆绑固定。
具体地，阻流膜可利用聚合物膜通过热定型模具加热裁剪做成，或者通过编织形成。而对于编织形成的阻流膜一般选用棉质或聚合物丝，其丝径为0.01～0.02mm，编织头数为2～32股，PPI(编织密度)为30～100，编织方式为n股压到m股上，其中n与m的数值可以相同或者不相同。另外，阻流膜上形成有多个孔隙，其孔隙的形状包括但不限于圆形、矩形等。具体地，孔隙尺寸的最大半径为15～600μm，孔隙百分数为10～90％。
可选地，阻流膜的材料包括但不限于是聚对苯二甲酸乙二酯(PET)、聚酯、聚氨酯、膨体聚四氟乙烯(ePTFE)、棉制品、硅或各种生物相容性聚合物或纤维的单种或组合。可选地，阻流膜上还可以加入药物、抗生素、抗血栓剂或抗血小板剂，比如肝素或华法林钠，这些药剂可以被浸渍在阻流膜中，或涂布在阻流膜上，当夹片夹住瓣叶后，药物可覆盖在瓣叶上或被血液吸收。
可选地，近端夹片1和远端夹片2可由生物相容材料的单独部件组装而成，这些部件可以由相同或者不同的材料形成，其材料包括但不限于不锈钢、镍钛诺、钛、钽、金属合金或 聚合物，或者也可以由植入后可被周围组织吸收或者溶解到血液中的生物相容材料制成。
综上，在使用本实施例提供的瓣膜夹合系统时，在瓣膜夹合系统未到达病变部位前，近端夹片1和远端夹片2处于收拢状态，且控制件9处于拉紧状态，固定片A6位于第一位置。当其送入指定位置后，可将控制件9处于放松状态，使固定片A6不位于第一位置，而后可使推送杆8在贯通孔内，朝向远离底座4的一侧移动，此时远端夹片2即可在连杆5的拉动下，相对于中心座体3展开。而当远端夹片2在位于瓣膜下方的病变位置展开后，还需解除对近端夹片1的两分支的控制，而近端夹片1的两分支在被释放后，可朝靠近远端夹片2的方向展开，此时远端夹片2和近端夹片1逐渐靠拢，以夹持位于二者之间的瓣叶。另外，当上述夹持动作完成后，可拉紧控制件9，以使固定片A6位于第一位置，实现推送杆8与固定片A6的相对固定，即可使远端夹片2锁紧。进一步地，若是出现三尖瓣夹持不牢靠或者需要取出瓣膜夹合系统的时候，则可重新放松控制件9，使固定片A6不位于第一位置，此时，推送杆8又可重新恢复移动，可重新调整远端夹片2的位置，为后续操作做好准备。
与上述相配合的，调节机构还包括连接于近端夹片1的牵引丝，牵引丝被配置为使近端夹片1未抵接中心座体3的部分靠近或远离中心座体3。可以理解的，本实施例中，牵引丝是用于控制近端夹片1的两分支，以使近端夹片1可在收拢状态和展开状态中来回切换。具体地，在近端夹片1的两分支内设置有丝腔，牵引丝一端设置于丝腔内，通过牵拉牵引丝的另一端即可实现近端夹片1的两分支相对中心座体3的偏转。
可选地，调节机构还包括连接于推送杆8的推拉丝，推拉丝被配置为使推送杆8能够在容纳腔内移动。具体地，推拉丝固定连接在推送杆8远离底座4的一端，当固定片A6不位于第一位置时，通过操纵推拉丝，即可使推送杆8在贯通孔内的移动，其中，推拉丝和推送杆8的固定方式可以为螺纹连接、铆接等。
可选的，所述瓣膜夹合系统还包括用于将所述调节机构和所述锁定机构输送至目标位置的输送机构，所述输送机构在靠近操作者的一端设置有固定件，所述固定件被配置为可拆卸地连接所述控制件。所述可拆卸连接地连接可以为螺纹连接、卡扣连接和铰链连接等方式。
实施例二
本实施例公开了一种瓣膜夹合系统，本实施例中的瓣膜夹合系统与实施例一中的瓣膜夹合系统的不同之处在于：如图5和图6所示，至少固定片B7为弹片，固定片B7被配置为使固定片A6抵靠于止挡凸起31，且位于第一位置，控制件9从推送杆8远离止挡凸起31的一侧绕过固定片A6和固定片B7，且拉动控制件9能够使固定片A6不位于第一位置。可选地，固定片B7和固定片A6均是弹片，但是固定片A6在受重力和固定片B7所施加的弹力作用时，与实施例一中不同，如图5所示，在放松控制件9时，固定片A6不能水平放置于容纳腔内，而是被固定片B7抵压于第一位置，此时推送杆8将被固定片A6卡住，即远端夹片2的位置将被固定。但是，如图6所示，在拉动控制件9时，固定片A6可受外力作用而离开 第一位置，此时，推送杆8可相对固定片A6滑动，即推拉推送杆8可以调整远端夹片2的展开或收拢状态。可选地，只有固定片B7为弹片，固定片A6受重力和固定片B7所施加的弹力作用以位于第一位置，此时推送杆8与固定片A6相对固定，当然，固定片A6也可以在控制件9的作用下离开第一位置，此时推送杆8可相对固定片A6移动。
综上，在使用本实施例提供的瓣膜夹合系统时，在瓣膜夹合系统未到达病变部位前，近端夹片1和远端夹片2处于收拢状态，且控制件9处于放松状态，固定片A6位于第一位置。当其送入指定位置后，可将控制件9处于拉紧状态，使固定片A6不位于第一位置，而后可使推送杆8在贯通孔内，朝向远离底座4的一侧移动，此时远端夹片2即可在连杆5的拉动下，相对于中心座体3展开。而当远端夹片2在位于瓣膜下方的病变位置展开后，还需解除对近端夹片1两分支的控制，而近端夹片1的两分支在被释放后，可朝靠近远端夹片2的方向展开，此时远端夹片2和近端夹片1逐渐靠拢，以夹持位于两者之间的三尖瓣。当上述夹持动作完成后，可放松控制件9，以使固定片A6位于第一位置，实现推送杆8与固定片A6的相对固定，即可使远端夹片2锁紧。进一步地，若是出现三尖瓣夹持不牢靠或者需要取出瓣膜夹合系统的时候，则可重新拉紧控制件9，使固定片A6不位于第一位置，此时，推送杆8又可重新恢复移动，可重新调整远端夹片2的位置，为后续操作做好准备。
除此之外，本实施例提供的一种瓣膜夹合系统的其余结构与实施例一中的瓣膜夹合系统均相同，在此不再赘述。
本申请的瓣膜夹合系统不仅可用于三尖瓣的夹持，也可以用于二尖瓣的夹持。本申请提出的瓣膜夹合系统，近端夹片具有弹性且卡接于中心座体，远端夹片转动连接于中心座体和底座体以靠近或远离近端夹片，通过远端夹片和近端夹片的配合，可以实现对于二尖瓣的夹持；中心座体具有容纳腔，固定片A和固定片B相互抵靠的卡设于容纳腔内，推送杆位于容纳腔内且穿过固定片A和固定片B连接于底座体，控制件从推送杆的任意一侧绕过固定片A和固定片B，控制件和固定片B能够调整固定片A在容纳腔内的位置，通过调整固定片A的位置，可以实现推送杆与固定片A的相对固定，也即远端夹片位置的锁定，这可确保远端夹片和近端夹片对二尖瓣的稳定夹持。该瓣膜夹合系统操作简单方便，降低了夹持难度，对操作者来说减小了手术的难度，对于患者来说降低了手术的风险。
以上实施方式只是阐述了本申请的基本原理和特性，本申请不受上述实施方式限制，在不脱离本申请精神和范围的前提下，本申请还有各种变化和改变，这些变化和改变都落入要求保护的本申请范围内。本申请要求保护范围由所附的权利要求书及其等效物界定。

Claims (13)

  1. 一种瓣膜夹合系统，其特征在于，包括：
    调节机构，包括近端夹片、远端夹片、中心座体和底座体，所述近端夹片连接所述中心座体，所述远端夹片分别连接于所述中心座体和所述底座体，所述中心座体具有容纳腔，所述中心座体侧壁上设有贯通的穿设孔；
    锁定机构，包括固定片A、固定片B、推送杆和控制件，所述固定片A和所述固定片B相互抵靠的设于所述容纳腔内，所述推送杆位于所述容纳腔内，且穿过所述固定片A和所述固定片B连接于所述底座体，所述控制件能够穿过所述穿设孔，且从所述推送杆的任意一侧绕过所述固定片A和所述固定片B；
    所述控制件和所述固定片B被共同配置为调整所述固定片A在所述容纳腔内的位置，当所述固定片A位于第一位置时，所述推送杆与所述固定片A相对固定，当所述固定片A不位于第一位置时，所述推送杆与所述固定片A相对移动。
  2. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述容纳腔内壁上设有止挡凸起，所述固定片A和所述固定片B均为弹片，所述固定片B被配置为使所述固定片A抵靠于所述止挡凸起，且不位于所述第一位置，所述控制件从所述推送杆靠近所述止挡凸起的一侧绕过所述固定片A和所述固定片B，且拉动所述控制件能够使所述固定片A位于第一位置。
  3. 根据权利要求2所述的瓣膜夹合系统，其特征在于，所述控制件为金属丝或高分子丝，所述控制件沿所述推送杆的轴向延伸，所述控制件能从所述推送杆的靠近所述止挡凸起的一侧绕过所述固定片A和所述固定片B，并且所述固定片A仅在靠近所述止挡凸起的一端连接所述控制件。
  4. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述容纳腔内壁上设有止挡凸起，所述固定片B为弹片，所述固定片B被配置为使所述固定片A抵靠于所述止挡凸起，且位于所述第一位置，所述控制件从所述推送杆远离所述止挡凸起的一侧绕过所述固定片A和所述固定片B，且拉动所述控制件能够使所述固定片A不位于第一位置。
  5. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述固定片A具有支脚A，所述支脚A卡设于所述中心座体的外侧壁上；所述固定片B具有支脚B，所述支脚B卡设于所述中心座体的外侧壁上。
  6. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述推送杆的表面粗糙度以及所述固定片A与所述推送杆抵接处的表面粗糙度均大于或等于1.6μm。
  7. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述近端夹片和/或所述远端夹片上设有阻流膜。
  8. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述中心座体上还设有安装部，所述远端夹片的一端通过所述安装部转动连接于所述中心座体。
  9. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述底座体包括连杆和底座，所述远端夹片未连接所述中心座体的部分转动连接于所述连杆，所述推送杆连接于所述底座。
  10. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述调节机构还包括连接于所述近端夹片的牵引丝，所述牵引丝被配置为使所述近端夹片未抵接所述中心座体的部分靠近或远离所述中心座体。
  11. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述调节机构还包括连接于所述推送杆的推拉丝，所述推拉丝被配置为使所述推送杆能够在所述容纳腔内移动。
  12. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述瓣膜夹合系统还包括用于将所述调节机构和所述锁定机构输送至目标位置的输送机构，所述输送机构在靠近操作者的一端设置有固定件，所述固定件被配置为可拆卸地连接所述控制件。
  13. 根据权利要求1所述的瓣膜夹合系统，其特征在于，所述近端夹片为弹性夹片；所述近端夹片卡接设置于所述中心座体；所述远端夹片转动连接于所述中心座体和所述底座体，以靠近或远离所述近端夹片。
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