WO2022222855A1 - 可操纵瓣膜夹合系统 - Google Patents

可操纵瓣膜夹合系统 Download PDF

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Publication number
WO2022222855A1
WO2022222855A1 PCT/CN2022/087045 CN2022087045W WO2022222855A1 WO 2022222855 A1 WO2022222855 A1 WO 2022222855A1 CN 2022087045 W CN2022087045 W CN 2022087045W WO 2022222855 A1 WO2022222855 A1 WO 2022222855A1
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WO
WIPO (PCT)
Prior art keywords
rod
control wire
hole
clip
clamping system
Prior art date
Application number
PCT/CN2022/087045
Other languages
English (en)
French (fr)
Inventor
王森
宋睿
王智琛
戴志豪
周国磊
黄中嵘
Original Assignee
上海申淇医疗科技有限公司
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.)
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Publication date
Application filed by 上海申淇医疗科技有限公司 filed Critical 上海申淇医疗科技有限公司
Priority to EP22790963.7A priority Critical patent/EP4327780A1/en
Publication of WO2022222855A1 publication Critical patent/WO2022222855A1/zh

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    • 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

Definitions

  • the present application relates to the technical field of medical devices, and in particular, to a steerable valve clamping system.
  • Mitral regurgitation the most common heart valve disease, is characterized by retrograde flow from the heart's left ventricle to the left atrium through a dysfunctional mitral valve.
  • the mitral valve acts as a check valve to prevent the backflow of oxygenated blood into the left atrium, so that oxygenated blood is pumped through the aortic valve to the aorta.
  • Valve regurgitation can significantly reduce the pumping efficiency of the heart, putting patients at risk for severe, progressive heart failure.
  • mitral regurgitation relies on valve replacement or repair, including leaflet and annular remodeling, the latter commonly known as valvuloplasty.
  • State-of-the-art techniques for mitral valve repair rely on suturing together adjacent segments of opposing leaflets, a technique known as the "bow-tie” or “edge-to-edge” technique. While all of these techniques can be very effective, they often rely on open heart surgery, usually through a sternotomy, to open the patient's chest and place the patient on cardiopulmonary bypass. The need to simultaneously open the chest and place the patient on cardiopulmonary bypass is traumatic and has associated high morbidity and mortality.
  • valve clamping system that can operate the valve leaflet independently.
  • the existing valve clamping system that can operate the valve leaflet independently uses two control wires to control the two proximal valves respectively. For the end clip, when caught multiple times, the two control wires are easily entangled together, which will increase the difficulty of the operation, affect the operation time, and increase the risk of the operation.
  • the present application discloses a steerable valve clamping system, which can improve the safety of mitral valve regurgitation interventional surgery.
  • a steerable valve clamping system comprising: a delivery sheath, a rod, a control wire, and a mitral valve repairer, the mitral valve repairer including a center seat and a proximal clip, the rod and the delivery sheath tube connection, the central seat is provided on the rod, the proximal clip is mounted on the central seat, the delivery sheath has a symmetrically arranged first through hole and a second through hole, the rod A third through hole is opened on the upper part, the control wire passes through the first through hole and is connected to the proximal clip on one side of the center seat, and the control wire also passes through the third through hole and then passes through the central seat. is connected with the proximal clip on the other side of the central seat, the control wire is also passed out of the delivery sheath through the second through hole, and the control wire is configured to be able to connect with all The rods are locked to each other.
  • the mitral valve repairer further includes a distal clip and an adjustment mechanism
  • the adjustment mechanism includes a transmission rod and an adjustment arm, the transmission rod passing through the rod and the center seat, respectively Then it is connected with the adjusting arm, one end of the distal clip is connected with the central seat, and the other end of the distal clip is connected with the adjusting arm.
  • the diameter of the third through hole is equal to or slightly larger than the wire diameter of the control wire, and the control wire located inside the rod is wound on part of the transmission rod.
  • the transmission rod is provided with a key slot, and the control wire inside the rod passes through the key slot.
  • the steerable valve clamping system further comprises a fixing sleeve, the fixing sleeve is sleeved on the outside of the rod, and the fixing sleeve is provided with an opening for the control wire to pass through, When the control wire and the rod are mutually locked, the opening and the third through hole are staggered.
  • the fixing sleeve is provided with a first rubber gasket at the opening.
  • the rod is provided with an external thread
  • the fixing sleeve is provided with an internal thread
  • the fixing sleeve is threadedly connected to the rod.
  • the rod is provided with a second rubber washer at the third through hole.
  • the proximal clip is provided with a plurality of connecting holes, and the control wire passes through two adjacent connecting holes in sequence to be connected to the proximal clip.
  • the mitral valve repairer further includes a tie wire that ties the control wire to the proximal clip.
  • the rod is provided with a plurality of the third through holes, and the plurality of the third through holes are distributed at intervals along the axial direction of the rod.
  • the present application discloses a steerable valve clamping system.
  • the above-mentioned steerable valve clamping system uses only one control wire to control the two proximal clips of the mitral valve repairer, and the control wire is controlled by It is configured to be able to lock with the rod. After the control wire and the rod are locked, the control wire on one side of the rod alone will not affect the control wire on the other side of the rod. Both ends of the control wire can be operated at the same time.
  • the end clips can be operated at the same time, or one end of the control wire can be operated independently to operate a proximal clip separately, so that both sides of the valve leaflets can be captured simultaneously through one control wire, and one side can be captured separately.
  • proximal clip Due to the use of a single control wire, one control wire is connected to the two proximal clips respectively, and the control wires are placed on both sides of the rod respectively, passing through the two lumens of the delivery sheath, and the tensioning and pushing during the operation is more effective. Safety, there will be no situation where the control wires are entangled with each other and overlapped with each other. At the same time, fewer control wires are used, which also reduces the possibility of entanglement between the control wires and the chordae tendineae, thereby improving the safety of the operation.
  • the force of the control wire will not deform the rod when catching the blade on one side, which can avoid the bending of the delivery sheath and the swing of the steerable valve clamping system, which is beneficial to Simplifying the complexity of surgical operations, saving surgical time, and further ensuring surgical safety.
  • FIG. 1 is a schematic structural diagram of a steerable valve clamping system in one embodiment
  • Figure 2 is a partial structural cross-sectional view of the steerable valve clamping system in one embodiment
  • FIG. 3 is a schematic structural diagram of a proximal clip in one embodiment
  • Fig. 4 is the structural representation of the delivery sheath in one embodiment
  • Fig. 5 is the structural representation of the rod in one embodiment
  • FIG. 6 is a schematic diagram of the locking structure of the control wire and the lever in one embodiment
  • FIG. 7 is a schematic diagram of the application of the steerable valve clamping system in one embodiment
  • FIG. 8 is a schematic structural diagram of a rod in yet another embodiment
  • FIG. 9 is a schematic diagram of the locking structure of the control wire and the lever in another embodiment.
  • FIG. 10 is a schematic diagram of the locking structure of the control wire and the rod in another embodiment.
  • 10-Delivery sheath 11-First through hole, 12-Second through hole, 13-Main lumen, 20-Rod, 21-Third through hole, 30-Control wire, 40-Mitral valve repairer, 41 -Center seat, 42-Proximal clip, 421-Connecting hole, 43-Distal clip, 44-Transmission rod, 441-Keyway, 45-Adjusting arm, 50-Second rubber gasket, 60-Fixing sleeve, 61 - Opening holes.
  • an embodiment of the steerable valve clamping system includes a delivery sheath 10, a rod 20, a control wire 30 and a mitral valve repairer 40.
  • the mitral valve repairer 40 includes a center seat 41 and The proximal clip 42, the rod 20 is connected with the delivery sheath 10, the central seat 41 is arranged on the rod 20, the proximal clip 42 is mounted on the central seat 41, and the delivery sheath 10 has the first through holes 11 and The second through hole 12, the rod 20 is provided with a third through hole 21, the control wire 30 passes through the first through hole 11 and is connected to the proximal clip 42 on one side of the center seat 41, and the control wire 30 also passes through the third through hole 12.
  • the hole 21 is then connected to the proximal clip 42 on the other side of the central seat 41 , the control wire 30 is also passed out of the delivery sheath 10 through the second through hole 12 , and the control wire 30 is configured to be able to interlock with the rod 20 .
  • the proximal clip 42 can be opened or closed relative to the central seat 41 , and the control wire 30 controls the proximal clip 42 to be opened or closed relative to the central seat 41 .
  • the proximal clip 42 expands outward relative to the central seat 41 , and in the locked state, the control wire 30 is pulled tightly against the central seat 41 .
  • the lower surface of the proximal clip 42 is provided with barbs, which facilitates the clamping of the valve leaflet by the proximal clip 42 .
  • the rod 20 is specifically made of nickel-titanium rod or other memory alloy materials, which can be selected and adjusted according to actual needs.
  • control wire 30 is a single wire, and the hardness of the control wire 30 is smaller than that of the rod 20 .
  • the control wire 30 can be, but is not limited to, a nickel-titanium wire, a stainless steel wire or a high-strength polymer wire. If it is a polymer wire, it can be a single wire that is wound with multiple strands. For the convenience of description, the following embodiments describe the control wire 30 as a nickel-titanium wire.
  • the above-described steerable valve clamping system uses only one control wire 30 to control the two proximal jaws 42 of the mitral valve repair 40, and the control wire 30 is configured to be able to interlock with the rod 20, which is interlocked with the rod.
  • the control wire 30 on one side of the lever 20 alone will not affect the control wire 30 on the other side of the lever 20, and both ends of the control wire 30 can be operated simultaneously to the two proximal clips 42 at the same time.
  • One end of the control wire 30 can also be operated independently to operate a proximal clip 42, so that the two-side simultaneous capture of the valve leaflets and the single-side individual capture can be achieved through one control wire 30, which improves the The capture capability of the proximal clip 42 .
  • control wire 30 Since a single control wire 30 is used, one control wire 30 is connected to the two proximal clips 42 respectively.
  • the control wire 30 is placed on both sides of the rod 20 and passes through the two lumens of the delivery sheath 10. During the operation The tensioning and pushing in the middle is safer, and the control wires 30 will not be entangled and overlapped with each other. At the same time, the use of fewer control wires 30 also reduces the possibility of the control wires 30 being entangled with the chordae tendineae, thereby improving the safety of the operation. sex.
  • the rod 20 is more rigid than the control wire 30, when the blade is caught on one side, the force of the control wire 30 will not cause deformation of the rod 20, which can avoid the bending of the delivery sheath 10 and the clamping of the steerable valve.
  • the swing of the system is beneficial to simplify the complexity of the operation, save the operation time, and further ensure the safety of the operation.
  • the mitral valve repairer 40 also includes a distal clip 43 and an adjustment mechanism.
  • the adjustment mechanism includes a transmission rod 44 and an adjustment arm 45.
  • the transmission rod 44 passes through the rod 20 and the center seat 41 and is connected to the adjustment arm 45 respectively.
  • One end of the distal clip 43 is connected to the center seat 41, and the distal clip 43 The other end is connected with the adjusting arm 45 .
  • the action of the transmission rod 44 drives the distal clip 43 to open or close relative to the center seat 41 through the adjustment arm 45 .
  • both the proximal clip 42 and the distal clip 43 are closed relative to the central seat 41, and after placing the mitral valve repairer 40 in the position where the mitral valve cannot be properly abutted (as shown in FIG.
  • the transmission rod 44 is operated to slide axially relative to the central seat 41.
  • the adjusting arm 45 drives the distal clip 43 to open relative to the central seat 41.
  • the control of the proximal clip 42 by the control wire 30 is released, the proximal clip 42 is released and spreads toward the distal clip 43, and the proximal clip 42 and the distal clip 43 are brought closer together to clamp the clip located at the distal end 43. leaflets between the two.
  • the components of mitral valve repair 40 may be made of biocompatible materials, which may be made of the same or different materials, including but not limited to stainless steel or other metals, cobalt, chromium, nitinol, nitinol , titanium, tantalum and other metal alloys or polymers. Additionally, some or all of these components may be made of biocompatible materials that will be absorbed by surrounding tissue or dissolved into the bloodstream after implantation.
  • the mitral valve repairer 40 is completely surrounded by tissue for several months after implantation, after which the device can dissolve or be absorbed without negative effects.
  • the proximal clip 42 is a flexible member formed of a shape memory material, specifically a nickel-titanium alloy.
  • the proximal clip 42 formed of nickel-titanium alloy undergoes heat-setting treatment, and then expands outward relative to the center seat 41 in a natural state, and in a locked state, is pulled tightly against the center seat 41 by the control wire 30 .
  • the proximal clip 42 and the distal clip 43 are partially or fully provided with a flow blocking membrane that should be durable to withstand multiple introduction cycles and be responsive when implanted in the heart. Withstand the lifespan of the cardiac cycle.
  • the material of the baffle film includes, but is not limited to, made of polyethylene terephthalate, polyester, cotton, polyurethane, expanded polytetrafluoroethylene (ePTFE), silicon or various biocompatible polymers or fibers. single or a combination thereof.
  • the flow blocking membrane has any suitable form, such as a fabric, mesh, textured braid, felt, loop or porous structure.
  • the choke film can also be configured as a friction element to increase adhesion.
  • Drugs, antibiotics, antithrombotic or antiplatelet agents such as heparin or warfarin sodium may also be added to the barrier membrane. These agents may be impregnated in, coated on, and coated on the valve leaflets after mitral valve repair 40 clamps the valve leaflets, or absorbed by the blood.
  • the proximal clip 42 is provided with a plurality of connection holes 421, and the control wire 30 passes through two adjacent connection holes 421 in sequence to be connected to the proximal clip 42.
  • the number of the connection holes 421 is, for example, From two to ten, the diameter of the connecting holes 421 is 0.02mm-3.0mm.
  • the control wire 30 is connected and fixed with the proximal clip 42 through the connecting hole 421 on the proximal clip 42.
  • the control wire 30 is tied to the proximal clip 42 .
  • the binding wire is made of biocompatible material.
  • the proximal clip 42 may not have a connecting hole 421, and the control wire can be directly connected to the control wire through the binding wire.
  • 30 is tied to the proximal clip 42 , of course, a connecting hole 421 can also be opened on the proximal clip 42 , and the binding wire passes through the connecting hole 421 to tie the control wire 30 to the proximal clip 42 .
  • the control wire 30 can also be passed through the mesh hole of the blocking membrane covered on the proximal clip 42 and fixed with a binding wire to make the connection more firm.
  • control wire 30 is passed through the first through hole 11 on the delivery sheath 10, and the control wire 30 is tied to the proximal clip 42 on the same side through the binding wire of the biocompatible material, Then pass through the third through hole 21 on the rod 20 to the other side, and also tie the control wire 30 to the proximal clip 42 on the other side through the binding wire of the biocompatible material, and then return to the delivery sheath 10 in the second through hole 12 above.
  • the delivery sheath 10 has a main lumen 13 for the rod 20 to pass through.
  • the first through holes 11 and the second through holes 12 are symmetrically arranged with respect to the main lumen 13 .
  • the cross-sectional shape of the through hole 12 may be circular, square, polygonal or other special-shaped shapes.
  • the fixed connection between the main lumen 13 and the rod 20 may be, but not limited to, riveting, bonding or screwing.
  • two sets of first through holes 11 and second through holes 12 are provided on the delivery sheath 10 in this embodiment. In other embodiments, only one set of the first through holes 11 and the second through holes 12 may be provided, or more than two sets of the first through holes 11 and the second through holes 12 may be provided, which is not done in this embodiment. Specific restrictions.
  • the rod 20 is provided with a plurality of third through holes 21 , and the plurality of third through holes 21 are distributed at intervals along the axial direction of the rod 20 .
  • the arrangement of the third through holes 21 with different height and low positions can be adapted to control wires of various materials, thereby reducing the difficulty of manufacturing the product.
  • the third through holes with different height and low positions can be used for the control wires 30 of the same material. 21 provides more options for passing the control wire 30, the product design is more flexible, and the safety is higher.
  • the control wire 30 of the nickel-titanium wire when the control wire 30 of the nickel-titanium wire is connected to the proximal clip 42 through the third through hole 21 on the nickel-titanium rod 20, due to the characteristics of the nickel-titanium wire being a super-elastic material, the nickel-titanium wire will bend so that the A certain arc will be formed in the rod 20, thereby forming an included angle between the control wire 30 and the rod 20.
  • the angle formed by the control wire 30 passing through the third through holes 21 at different positions and the angle formed between the rod 20 is different.
  • the angle of the included angle can achieve a smaller force to complete the manipulation of the proximal clip 42 .
  • the control wire 30 When the included angle between the control wire 30 and the rod 20 increases, the control wire 30 not only has the effect of tightening and fixing, but also has a certain pushing effect when the proximal clip 42 is released, and the metal wire with hardness can also play a certain role of pushing.
  • the proximal clips 42 and the distal clips 43 hold the valve leaflets more tightly and firmly, which helps to improve the surgical effect and the effect of the product.
  • the coordination of wires of different materials and the third through holes 21 at different positions has lower requirements on the locking and release of the proximal clip 42, thereby reducing the requirements on the strength and thickness of the proximal clip 42.
  • the sheet 42 can choose a thinner size, which can increase the feasibility of manufacturing and design, reduce the difficulty of the process, and help obtain a more uniform and stable product. Compared with the proximal clip 42 with a large thickness, the thickness is small. The proximal clip 42 can significantly reduce the damage of the instrument to the valve leaflets during the operation, which is beneficial to improve the safety of the instrument and the operation.
  • the position of the control wire 30 on the proximal clip 42 remains unchanged, and after the angle between the control wire 30 and the rod 20 is increased, when the mitral valve repair device 40 is released, a small force can be applied to remove the Pulling out the control wire 30 can reduce the swing of the steerable valve clamping system during disengagement, and can also reduce the force of the delivery sheath 10 and avoid the delivery sheath 10 from bending, which can effectively improve the maneuverability of the instrument and improve the operation efficiency. safety.
  • the angle between the control wire 30 and the rod 20 is 0° to ⁇ 150°.
  • the specific number of the third through holes 21 can be selected according to the required angle range. Specifically, the diameter of the third through holes 21 is 0.02 mm-10 mm, and the number of the third through holes 21 is two to twenty. As shown in FIG. 5 , in this embodiment, the number of the third through holes 21 is two. In other embodiments, the number of the third through holes 21 may be more than two, which is not specifically limited in this embodiment. .
  • only one third through hole 21 may be opened on the rod 20 , which is not specifically limited in the above-mentioned embodiments.
  • the diameter of the third through hole 21 is slightly larger than the wire diameter of the control wire 30 , and the control wire 30 inside the rod 20 is wound on part of the transmission rod 44 .
  • the diameter of the third through hole 21 is only slightly larger than the wire diameter of the control wire 30, so that the control wire 30 can pass through exactly.
  • the diameter of the third through hole 21 can also be equal to the control wire 30.
  • the wire diameter is not specifically limited in this embodiment. In this embodiment, when the control wire 30 is connected to the proximal clip 42 through the third through hole 21, due to the existence of the radian, the control wire 30 will push against the inner wall of the rod 20 at the third through hole 21.
  • the diameter of the third through hole 21 is only slightly larger than the wire diameter of the control wire 30, so that a frictional force is generated between the inner wall of the rod 20 at the third through hole 21 and the control wire 30 to lock the control wire 30, and the operation side
  • the control wire 30 on the other side will not affect the control wire 30 on the other side, and will not pull the proximal clip 42 on the other end, so that independent grasping of the unilateral valve leaflet can be achieved.
  • control wire 30 penetrates into the rod 20 from one end of the third through hole 21 , passes through the other end of the third through hole 21 and exits the rod 20 after bypassing part of the transmission rod 44 , and the control wire 30 located inside the rod 20 is wound around On the part of the transmission rod 44 bypassed by it and located between the transmission rod 44 and the inner wall of the rod 20, a certain frictional force will be generated between the transmission rod 44 and the control wire 30, and the control wire 30 will be caused by the interference of the transmission rod 44.
  • Moving closer to the wall of the rod 20 can increase the frictional force between the control wire 30 and the inner wall of the rod 20 through the frictional force between the control wire 30 and the transmission rod 44 and the frictional force between it and the inner wall of the rod 20 respectively Keeping the locking can further enhance the locking stability of the control wire 30, and the independent grasping of the unilateral valve leaflet is more reliable.
  • a pulling force is applied to one end of the control wire 30, and the pulling force is greater than the frictional force between the control wire 30 at the third through hole 21 and the inner wall of the rod 20 and the control wire 30 respectively.
  • the control wire 30 can be extracted by the sum of the frictional force between the transmission rod 44 and the inner wall of the rod 20 , and the release operation of the mitral valve repairer 40 is completed.
  • the rod 20 is provided with a second rubber washer 50 at the third through hole 21 .
  • the provision of the second rubber washer 50 can further reduce the size of the control wire 30 and the third through hole 21 the gap between the hole walls, and the second rubber washer 50 can increase the friction force on the control wire 30, so that the control wire 30 will not move without being pulled or pushed, which is helpful to further strengthen the control wire 30's of locking stability.
  • the transmission rod 44 is provided with a key groove 441 , and the control wire 30 inside the rod 20 passes through the key groove 441 .
  • the transmission rod 44 is provided with a key slot 441 for the control wire 30 to pass through.
  • One end goes out of the rod 20 .
  • the length of the keyway 441 is greater than the sliding stroke of the transmission rod 44.
  • the notch of 441 is aligned with the third through hole 21, and the control wire 30 and the rod body of the transmission rod 44 will not have any contact, which can prevent the transmission rod 44 from interfering with the control wire 30, so that the mitral valve repairer 40 can smoothly Release and grasp the leaflets.
  • the rotating transmission rod 44 is rotated by a preset angle, so that the notch of the keyway 441 is staggered from the third through hole 21 .
  • the control wire 30 is slightly at the keyway 441.
  • the transmission rod 44 is rotated in the opposite direction to rotate the preset angle, so that the notch of the keyway 441 is aligned with the third through hole 21, and then the control wire 30 can be pulled out by applying a pulling force, and the control wire 30 can be pulled out.
  • the withdrawal operation of the wire 30 is simple and convenient.
  • a second rubber washer 50 may also be provided on the rod 20 at the third through hole 21 to further enhance the locking stability of the control wire 30 .
  • the difference between the steerable valve clamping system of this embodiment and the above-mentioned embodiment is only that the control wire 30 is locked by opening a key slot 441 on the transmission rod 44 , and other structures and components are the same, and will not be repeated here.
  • the steerable valve clamping system further includes a fixing sleeve 60 , the fixing sleeve 60 is sleeved on the outside of the rod 20 , and the fixing sleeve 60 is provided with an opening for the control wire 30 to pass through. 61.
  • the opening 61 and the third through hole 21 are staggered.
  • the rod 20 is provided with an external thread
  • the fixing sleeve 60 is provided with an internal thread
  • the fixing sleeve 60 is threadedly connected to the rod 20 .
  • Two openings 61 are symmetrically opened on the fixed sleeve 60.
  • the two openings 61 are aligned and communicated with the third through hole 21 so that the control wire 30 can smoothly pass through the rod 20, and the control
  • the wire 30 is connected to the proximal clip 42 on one side, passes through the opening 61 on one side, passes through the third through hole 21, and then passes through the opening 61 on the other side and passes through the proximal clip 42 on the other side. connect.
  • the fixing sleeve 60 is rotated, so that the two through holes on the fixing sleeve 60 are respectively staggered from the third through hole 21, so that the control wire 30 can stand against the inner wall of the rod 20 and the fixing sleeve 60 respectively.
  • the friction force is formed between the control wire 30 and the inner wall of the rod 20 and between the control wire 30 and the inner wall of the fixing sleeve 60, respectively, so that the control wire 30 is in a locked state.
  • the mitral valve repairer 40 when the mitral valve repairer 40 is released, a pulling force is applied to one end of the control wire 30, and the pulling force is greater than the friction force between the control wire 30 and the inner wall of the rod 20 and the friction between the control wire 30 and the inner wall of the fixing sleeve 60.
  • the control wire 30 can be extracted by the sum of the force, and the release and operation of the mitral valve repairer 40 is convenient.
  • the fixing sleeve 60 is provided with a first rubber washer at the opening 61 .
  • the setting of the first rubber washer can increase the frictional force between the control wire 30 and the inner wall of the fixing sleeve 60 , which is beneficial to improve the control wire 30's of locking stability.
  • a second rubber washer 50 may also be provided on the rod 20 at the third through hole 21 to further enhance the locking stability of the control wire 30 .
  • the difference between the steerable valve clamping system of this embodiment and the above-mentioned embodiment is only that the locking of the control wire 30 is realized by setting the fixing sleeve 60 , and other structures and components are the same, and will not be repeated here.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
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Abstract

一种可操纵瓣膜夹合系统包括输送鞘管（10）、杆（20）、控制线（30）和二尖瓣修复器（40）。二尖瓣修复器（40）包括中心座（41）和近端夹片（42）。杆（20）与输送鞘管（10）连接，中心座（41）设置在杆（20）上，近端夹片（42）安装在中心座（41）上。输送鞘管（10）具有对称设置的第一通孔（11）和第二通孔（12），杆（20）上开设有第三通孔（21）。控制线（30）穿过第一通孔（11）与中心座（41）一侧的近端夹片（42）连接，控制线（30）还穿过第三通孔（21）与中心座（41）另一侧的近端夹片（42）连接，控制线（30）还通过第二通孔（12）穿出至输送鞘管（10）外，且控制线（30）被配置为能够与杆（20）相互锁定。上述的可操纵瓣膜夹合系统能够提高二尖瓣反流介入手术的安全性。

Description

可操纵瓣膜夹合系统 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种可操纵瓣膜夹合系统。
背景技术
二尖瓣反流是最常见的心脏瓣膜疾病，二尖瓣反流的特征是通过机能不健全的二尖瓣从心脏的左心室到左心房的逆行流动。在正常的心脏收缩(心脏收缩)周期期间，二尖瓣作为止回阀，以防止含氧血液回流进左心房，这样，含氧血液通过主动脉瓣泵送到主动脉。瓣膜反流会显著降低心脏的泵送效率，从而将患者置于严重的、渐进的心脏衰竭的风险。
最常见的治疗二尖瓣反流依赖瓣膜置换或修复，包括瓣叶和环重塑，后者一般称为瓣膜成形术。用于二尖瓣修复的最新技术依赖将相对瓣叶的相邻片段缝合到一起，这被称为“蝴蝶结”或“缘对缘”技术。尽管所有这些技术可以非常有效，但它们通常依赖开心脏术，通常通过胸骨切开术打开患者的胸部，并将患者置于体外循环。同时打开胸部和将患者置于体外循环的需要是有创伤性的并具有相关的高发病率和死亡率。
近年来，随着瓣膜介入治疗技术获得的突破性进展，二尖瓣反流介入治疗器械目前已成为国内外心血管器械研发的重点方向之一。传统瓣膜夹合系统多为双臂抓捕，没有考虑到手术操作时只抓捕一个瓣叶的情况，使得手术遇到这种情况，只能同时释放两个瓣叶再重新抓捕，夹持难度大且容易造成瓣叶损伤，因此，需要设计单侧瓣叶能够单独操作的瓣膜夹合系统，然而，现有瓣叶能够单独操作的瓣膜夹合系统采用两根控制线分别控制两个近端夹片，在多次抓捕时，两根控制线容易缠绕在一起，会增加手术难度、影响手术时间，导致手术风险增加。
发明内容
有鉴于此，本申请公开一种可操纵瓣膜夹合系统，能够提高二尖瓣反流介入手术的安全性。
一种可操纵瓣膜夹合系统，包括：输送鞘管、杆、控制线和二尖瓣修复器，所述二尖瓣修复器包括中心座和近端夹片，所述杆与所述输送鞘管连接，所述中心座设置在所述杆上，所述近端夹片安装在所述中心座上，所述输送鞘管具有对称设置的第一通孔和第二通孔，所述杆上开设有第三通孔，所述控制线穿过所述第一通孔与所述中心座一侧的所述近端夹片连接，所述控制线还穿过所述第三通孔再与所述中心座另一侧的所述近端夹片连接，所述控制线还通过所述第二通孔穿出至所述输送鞘管外，且所述控制线被配置为能够与所述杆相互锁 定。
在其中一个实施例中，所述二尖瓣修复器还包括远端夹片和调节机构，所述调节机构包括传动杆和调节臂，所述传动杆分别穿过所述杆和所述中心座后与所述调节臂连接，所述远端夹片的一端与所述中心座连接，所述远端夹片的另一端与所述调节臂连接。
在其中一个实施例中，所述第三通孔的孔径等于或略大于所述控制线的线径，位于所述杆内部的所述控制线缠绕在部分所述传动杆上。
在其中一个实施例中，所述传动杆上开设有键槽，位于所述杆内部的所述控制线穿过所述键槽。
在其中一个实施例中，所述可操纵瓣膜夹合系统还包括固定套，所述固定套套接于所述杆外侧，所述固定套上开设有用于供所述控制线穿过的开孔，所述控制线与所述杆相互锁定时，所述开孔与所述第三通孔错开。
在其中一个实施例中，所述固定套上于所述开孔处设置有第一橡胶垫圈。
在其中一个实施例中，所述杆上设置有外螺纹，所述固定套上设置有内螺纹，所述固定套与所述杆螺纹连接。
在其中一个实施例中，所述杆上于所述第三通孔处设置有第二橡胶垫圈。
在其中一个实施例中，所述近端夹片上开设有多个连接孔，所述控制线依次穿过相邻的两个所述连接孔以与所述近端夹片连接。
在其中一个实施例中，所述二尖瓣修复器还包括绑线，所述绑线将所述控制线系在所述近端夹片上。
在其中一个实施例中，所述杆上开设有多个所述第三通孔，多个所述第三通孔沿所述杆的轴线方向间隔分布。
从上述的技术方案可知，本申请公开了可操纵瓣膜夹合系统，上述的可操纵瓣膜夹合系统只使用一根控制线控制二尖瓣修复器的两个近端夹片，且控制线被配置为能够与杆相互锁定，控制线与杆相互锁定后，单独操作杆一侧的控制线不会对杆另一侧的控制线造成影响，既可以同时操作控制线的两端对两个近端夹片同时进行操作，也可以单独操作控制线的一端对一个近端夹片进行单独操作，从而通过一根控制线可以实现对瓣叶的双侧同时抓捕，以及单侧单独抓捕，提升了近端夹片的捕获能力。由于使用单根控制线，一根控制线分别连接两个近端夹片，控制线分别置于杆的两侧，穿过输送鞘管的两个管腔，在手术过程中的拉紧推送更加安全，不会出现控制线彼此相互缠绕搭接的情况，同时，采用更少的控制线，也降低了控制线与腱索缠绕的可能性，进而提升手术安全性。并且，由于杆相较于控制线更为坚硬，单侧抓捕叶片时，控制线的作用力不会对杆造成形变，能够避免出现输送鞘管弯曲及可操纵瓣膜夹合系统摆动，有利于简化手术操作复杂程度、节省手术时间，能够进一步确保手术安全性。
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是一个实施例中可操纵瓣膜夹合系统的结构示意图；
图2是一个实施例中可操纵瓣膜夹合系统的部分结构剖视图；
图3是一个实施例中近端夹片的结构示意图；
图4是一个实施例中输送鞘管的结构示意图；
图5是一个实施例中杆的结构示意图；
图6是一个实施例中控制线与杆的锁定结构示意图；
图7是一个实施例中可操纵瓣膜夹合系统的应用示意图；
图8是又一个实施例中杆的结构示意图；
图9是另一个实施例中控制线与杆的锁定结构示意图；
图10是再一个实施例中控制线与杆的锁定结构示意图。
附图标记说明：
10-输送鞘管，11-第一通孔，12-第二通孔，13-主管腔，20-杆，21-第三通孔，30-控制线，40-二尖瓣修复器，41-中心座，42-近端夹片，421-连接孔，43-远端夹片，44-传动杆，441-键槽，45-调节臂，50-第二橡胶垫圈，60-固定套，61-开孔。
具体实施方式
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。
在本申请的描述中，需要理解的是，术语“上”、“下”、“前”、“后”、“左”、“右”、“竖直”、“水平”、“顶”、“底”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，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。
请同时参阅图1至图7，一实施例的可操纵瓣膜夹合系统包括输送鞘管10、杆20、控制线30和二尖瓣修复器40，二尖瓣修复器40包括中心座41和近端夹片42，杆20与输送鞘管10连接，中心座41设置在杆20上，近端夹片42安装在中心座41上，输送鞘管10具有对称设置的第一通孔11和第二通孔12，杆20上开设有第三通孔21，控制线30穿过第一通孔11与中心座41一侧的近端夹片42连接，控制线30还穿过第三通孔21再与中心座41另一侧的近端夹片42连接，控制线30还通过第二通孔12穿出至输送鞘管10外，且控制线30被 配置为能够与杆20相互锁定。
具体地，近端夹片42可相对于中心座41打开或合拢，控制线30控制近端夹片42相对于中心座41打开或合拢。在自然状态下近端夹片42相对于中心座41向外展开，锁定状态为通过控制线30拉紧紧贴于中心座41处。进一步地，近端夹片42的下表面带有倒钩，有利于近端夹片42对于瓣叶的夹持。此外，杆20具体为镍钛杆或其它记忆合金材质，可以根据实际需求进行选取与调整。
进一步地，控制线30为单根丝线，控制线30的硬度小于杆20的硬度。具体地，控制线30可以但不局限于为选自镍钛丝、不锈钢丝或高强度的高分子线，若为高分子线，可以为多股缠绕成的单根丝线。为方便说明，以下实施例以控制线30为镍钛丝进行说明。
上述的可操纵瓣膜夹合系统只使用一根控制线30控制二尖瓣修复器40的两个近端夹片42，且控制线30被配置为能够与杆20相互锁定，控制线30与杆20相互锁定后，单独操作杆20一侧的控制线30不会对杆20另一侧的控制线30造成影响，既可以同时操作控制线30的两端对两个近端夹片42同时进行操作，也可以单独操作控制线30的一端对一个近端夹片42进行单独操作，从而通过一根控制线30可以实现对瓣叶的双侧同时抓捕，以及单侧单独抓捕，提升了近端夹片42的捕获能力。由于使用单根控制线30，一根控制线30分别连接两个近端夹片42，控制线30分别置于杆20的两侧，穿过输送鞘管10的两个管腔，在手术过程中的拉紧推送更加安全，不会出现控制线30彼此相互缠绕搭接的情况，同时，采用更少的控制线30，也降低了控制线30与腱索缠绕的可能性，进而提升手术安全性。并且，由于杆20相较于控制线30更为坚硬，单侧抓捕叶片时，控制线30的作用力不会对杆20造成形变，能够避免出现输送鞘管10弯曲及可操纵瓣膜夹合系统摆动，有利于简化手术操作复杂程度、节省手术时间，能够进一步确保手术安全性。
在一个实施例中，二尖瓣修复器40还包括远端夹片43和调节机构。其中，调节机构包括传动杆44和调节臂45，传动杆44分别穿过杆20和中心座41后与调节臂45连接，远端夹片43的一端与中心座41连接，远端夹片43的另一端与调节臂45连接。具体地，传动杆44动作通过调节臂45带动远端夹片43相对于中心座41打开或合拢。初始状态时，近端夹片42和远端夹片43均相对于中心座41合拢，将二尖瓣修复器40置于二尖瓣不能正常对合的位置(如图7所示)后，操作传动杆44相对于中心座41沿轴向滑动，在传动杆44的拉动下，调节臂45带动远端夹片43相对于中心座41张开，当远端夹片43位于瓣膜下方的病变位置展开后，解除控制线30对近端夹片42的控制，近端夹片42被释放而向远端夹片43展开靠拢，近端夹片42与远端夹片43靠拢以夹持位于二者之间的瓣叶。当出现一侧瓣叶夹持不牢靠的问题时，重新拉紧该侧的控制线30使对应的近端夹片42远离远端夹片43以释放近端夹片42，之后，再次解除控制线30对近端夹片42的控制重新夹持瓣叶，直至瓣叶夹持牢靠。当确定二尖瓣修复器40完全夹紧病变部位，二尖瓣反流情况得到明显改善后，拉动控制 线30的一端将控制线30抽出，使近端夹片42完全释放，再将输送装置撤出体外即完成手术。进一步地，控制线30撤出体外时，单根的控制线30更容易撤出，撤出操作简单，耗时时间更短，有利于缩短手术时间。
二尖瓣修复器40的各组成部件可以通过生物相容材料制成，这些部件可以由相同或不同的材料制成，包括但不限于不锈钢或其他金属、钴、铬、镍钛诺、镍钛、钛、钽等金属合金或聚合物。另外，一些或所有这些部件可以由植入后将被周围组织吸收或者溶解到血流中的生物相容材料制成。二尖瓣修复器40在植入后的几个月内完全被组织包围，之后，设备可溶解或被吸收，而不会产生负面影响。具体地，在一个实施例中，近端夹片42为由形状记忆材料形成的挠性构件，具体采用镍钛合金。采用镍钛合金形成的近端夹片42经过热定型处理后，在自然状态下相对于中心座41向外展开，锁定状态为通过控制线30拉紧紧贴于中心座41处。
进一步地，在一个实施例中，近端夹片42和远端夹片43部分或完全带有阻流膜，阻流膜应当耐用以承受多次引入周期并且在被植入在心脏内时可承受心动周期的寿命。阻流膜的材料包括但不限于由聚对苯二甲酸乙二酯、聚酯、棉制品、聚氨酯、膨体聚四氟乙烯(ePTFE)、硅或各种生物相容性聚合物或纤维的单种或其组合。阻流膜具有任何合适的形式，比如织物、网状物、带纹理的编织物、毛毡、环状结构或多孔结构。阻流膜还可以构造成摩擦元件，增加附着力。阻流膜上还可以加入包括药物、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，涂布在阻流膜上，在二尖瓣修复器40夹住瓣叶后药物可覆盖在瓣叶上，或被血液吸收。
在一个实施例中，近端夹片42上开设有多个连接孔421，控制线30依次穿过相邻的两个连接孔421以与近端夹片42连接，连接孔421的数量具体例如为两个至十个，连接孔421的直径为0.02mm-3.0mm。上述实施例中，控制线30通过近端夹片42上的连接孔421实现与近端夹片42连接固定，在另一个实施例中，二尖瓣修复器40还包括绑线，绑线将控制线30系在近端夹片42上。具体地，绑线采用生物相容材料制成，采用绑线将控制线30固定在近端夹片42上时，近端夹片42上可以不开设连接孔421，直接通过绑线将控制线30系在近端夹片42上，当然，也可以在近端夹片42上开设连接孔421，绑线穿过连接孔421将控制线30系在近端夹片42上。更进一步地，还可以使控制线30穿过覆盖在近端夹片42上的阻流膜网孔中，并用绑线加以固定，使其连接更加牢固。具体地，本实施例中，控制线30从输送鞘管10上的第一通孔11穿出，通过生物相容材料的绑线将控制线30系在同一侧的近端夹片42上，再穿过杆20上的第三通孔21前往另一侧，同样的通过生物相容材料的绑线将控制线30系在另一侧的近端夹片42上，再返回输送鞘管10上的第二通孔12中。
如图4所示，输送鞘管10具有用于供杆20穿过的主管腔13，第一通孔11和第二通孔12相对于主管腔13对称设置，第一通孔11和第二通孔12的横截面形状可以是圆形、方形、多边形或其他异形形状。主管腔13与杆20之间固定连接，可以但不局限于铆接、粘接或螺 纹连接。为方便使用，本实施例中的输送鞘管10上设置两组第一通孔11和第二通孔12。在其他实施例中，也可以仅设置一组第一通孔11和第二通孔12，还可以设置多于两组的第一通孔11和第二通孔12，本实施例并不做具体限定。
在一个实施例中，杆20上开设有多个第三通孔21，多个第三通孔21沿杆20的轴线方向间隔分布。本实施例中，设置高低位置不同的第三通孔21能够适应多种材料的控制丝，降低产品的生产制造难度，并且，对于同一种材料的控制线30，高低位置不同的第三通孔21提供了更多的穿控制线30的选择，产品设计更灵活，安全性更高。
具体地，当镍钛丝的控制线30穿过镍钛杆20上的第三通孔21连接到近端夹片42时，由于镍钛丝为超弹性材料的特性，镍钛丝会弯曲从而在杆20内会形成一定的弧度，从而在控制线30和杆20之间形成夹角，控制线30穿过不同位置的第三通孔21与杆20间形成的夹角的角度不同，合适的夹角角度可以实现较小的力完成对近端夹片42的操控。控制线30和杆20之间的夹角增大时，控制线30不仅有拉紧固定作用，在释放近端夹片42时，具有硬度的金属线还能够起到一定的推送作用，可以使近端夹片42和远端夹片43对于瓣叶的夹持更紧密牢固，有助于提高手术效果，提高产品作用效果。不同材料的线材和不同位置的第三通孔21的配合，对于近端夹片42的锁定与释放的要求更低，从而可以降低对近端夹片42强度、厚度等的要求，近端夹片42可以选择更薄的尺寸，能够增大制作和设计的可行性，降低工艺难度，有利于得到更均匀稳定的产品，且相较于厚度尺寸大的近端夹片42，厚度尺寸小的近端夹片42在手术中可以明显减小器械对于瓣叶的损伤，有利于提高器械安全性和手术安全性。并且，控制线30在近端夹片42上的位置不变，控制线30和杆20之间的夹角增大后，在二尖瓣修复器40解脱时，施加较小的力即可将控制线30拉出，可以降低解脱时可操纵瓣膜夹合系统的摆动，也能够降低输送鞘管10的受力，避免输送鞘管10发生弯曲，能够有效提升器械的可操纵性，提升手术的安全性。
在一个实施例中，控制线30和杆20之间的夹角的角度为0°至～150°，实际应用中可根据需要的角度范围选择具体的第三通孔21的数量。具体地，第三通孔21的直径为0.02mm-10mm，第三通孔21的数量为两个至二十个。如图5所示，本实施例中，第三通孔21的数量为两个，在其它实施例中，第三通孔21的数量还可以多于两个，本实施例并不做具体限定。
进一步地，在其它实施例中，为加工方便，也可以在杆20上只开设一个第三通孔21，上述的实施例并不做具体限定。
如图6所示，在一个实施例中，第三通孔21的孔径略大于控制线30的线径，位于杆20内部的控制线30缠绕在部分传动杆44上。具体地，第三通孔21的孔径仅仅略大于控制线30的线径，使控制线30能够恰好穿过，当然，在其它实施例中，第三通孔21的孔径还可以等于控制线30的线径，本实施例并不做具体限定。本实施例中，当控制线30穿过第三通孔 21连接到近端夹片42时，由于弧度的存在，控制线30会于第三通孔21处顶到杆20的内壁上，由于第三通孔21的孔径仅仅略大于控制线30的线径，从而会在第三通孔21处的杆20的内壁和控制线30之间产生摩擦力以使控制线30锁定，操作一侧的控制线30对于另一侧的控制线30不会造成影响，不会拉动另一端的近端夹片42，可以实现单侧瓣叶独立抓取。
进一步地，控制线30由第三通孔21的一端穿入杆20内，绕过部分传动杆44后由第三通孔21的另一端穿出杆20，位于杆20内部的控制线30缠绕在被其绕过的部分传动杆44上并位于传动杆44和杆20的内壁之间，传动杆44与控制线30之间会产生一定的摩擦力，由于传动杆44的干涉使控制线30进一步靠近杆20壁，能够增大控制线30与杆20的内壁之间的摩擦力，控制线30分别通过其与传动杆44之间的摩擦力和其与杆20的内壁之间的摩擦力保持锁定，能够进一步增强控制线30的锁定稳定性，单侧瓣叶独立抓取更可靠。更进一步地，在二尖瓣修复器40解脱时，对控制线30的一端施加拉力，拉力大于控制线30于第三通孔21处与杆20的内壁之间的摩擦力及控制线30分别与传动杆44及杆20的内壁之间摩擦力之和即可将控制线30抽取，完成二尖瓣修复器40解脱操作。
如图8所示，在又一个实施例中，杆20上于第三通孔21处设置有第二橡胶垫圈50，设置第二橡胶垫圈50能够进一步减小控制线30与第三通孔21的孔壁之间的空隙，且第二橡胶垫圈50能够增加控制线30所受的摩擦力，使控制线30在不受拉力或推拉的情况下不会发生移动，有助于进一步增强控制线30的锁定稳定性。
如图9所示，在另一个实施例中，传动杆44上开设有键槽441，位于杆20内部的控制线30穿过键槽441。具体地，传动杆44上开设有供控制线30穿过的键槽441，控制线30由第三通孔21的一端穿入杆20内，进一步穿过键槽441后由第三通孔21的另一端穿出杆20。为避免传动杆44对控制线30造成干涉，键槽441的长度大于传动杆44的滑动行程，在推动传动杆44释放远端夹片43及在操作控制线30释放近端夹片42时，键槽441的槽口与第三通孔21对准，控制线30与传动杆44杆体不会有任何的接触，可以避免传动杆44对控制线30造成干涉，使二尖瓣修复器40能够流畅地释放并抓取瓣叶。当单侧瓣叶抓取不牢靠，需要重新抓取时，旋转传动杆44转动预设角度，使键槽441的槽口与第三通孔21错开，此时，控制线30于键槽441处轻微缠绕在传动杆44上，在控制线30和传动杆44之间以及控制线30和杆20的内壁之间分别产生摩擦力，实现控制线30的单侧抓捕锁定，使近端夹片42可以保持稳定的锁定状态。
进一步地，在二尖瓣修复器40解脱时，反向旋转传动杆44转动预设角度，使键槽441的槽口与第三通孔21对准后施加拉力即可将控制线30抽出，控制线30撤出操作简单方便。更进一步地，本实施例中，也可以在杆20上于第三通孔21处设置第二橡胶垫圈50以进一步增强控制线30的锁定稳定性。本实施例的可操纵瓣膜夹合系统与上述实施例的区别仅在于通过在传动杆44上开设键槽441实现控制线30锁定，其它结构及组成均相同，在此不再赘述。
如图10所示，再一个实施例中，可操纵瓣膜夹合系统还包括固定套60，固定套60套接于杆20外侧，固定套60上开设有用于供控制线30穿过的开孔61，控制线30与杆20相互锁定时，开孔61与第三通孔21错开。具体地，杆20上设置有外螺纹，固定套60上设置有内螺纹，固定套60与杆20螺纹连接。固定套60上对称开设有两个开孔61，可操纵瓣膜夹合系统装配过程中，两个开孔61均与第三通孔21对齐连通以使控制线30能够顺利穿过杆20，控制线30与一侧的近端夹片42连接后穿过一侧的开孔61后穿过第三通孔21再通过另一侧的开孔61穿出与另一侧的近端夹片42连接。可操纵瓣膜夹合系统装配完成后，旋转固定套60，使固定套60上的两个通孔分别与第三通孔21错开，进而使控制线30分别顶住杆20的内壁和固定套60的内壁，分别在控制线30和杆20的内壁之间及控制线30和固定套60的内壁之间形成摩擦力，使控制线30处于锁定状态。将二尖瓣修复器40置于二尖瓣不能正常对合的位置后，同时操作控制线30的两端可实现两端的近端夹片42同时释放或抓取，需要抓取单侧瓣叶时，仅操作一端的控制线30不会对另一端的控制线30造成影响，单侧瓣叶独立抓取稳定可靠。进一步地，在二尖瓣修复器40解脱时，对控制线30的一端施加拉力，拉力大于控制线30与杆20的内壁之间的摩擦力及控制线30与固定套60的内壁之间摩擦力之和即可将控制线30抽取，二尖瓣修复器40解脱操作方便。
在一个实施例中，固定套60上于开孔61处设置有第一橡胶垫圈，设置第一橡胶垫圈能够增大控制线30与固定套60的内壁之间的摩擦力，有利于提高控制线30的锁定稳定性。进一步地，本实施例中，也可以在杆20上于第三通孔21处设置第二橡胶垫圈50以进一步增强控制线30的锁定稳定性。本实施例的可操纵瓣膜夹合系统与上述实施例的区别仅在于通过设置固定套60实现控制线30锁定，其它结构及组成均相同，在此不再赘述。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (11)

  1. 一种可操纵瓣膜夹合系统，其特征在于，包括：输送鞘管(10)、杆(20)、控制线(30)和二尖瓣修复器(40)，所述二尖瓣修复器(40)包括中心座(41)和近端夹片(42)，所述杆(20)与所述输送鞘管(10)连接，所述中心座(41)设置在所述杆(20)上，所述近端夹片(42)安装在所述中心座(41)上，所述输送鞘管(10)具有对称设置的第一通孔(11)和第二通孔(12)，所述杆(20)上开设有第三通孔(21)，所述控制线(30)穿过所述第一通孔(11)与所述中心座(41)一侧的所述近端夹片(42)连接，所述控制线(30)还穿过所述第三通孔(21)与所述中心座(41)另一侧的所述近端夹片(42)连接，所述控制线(30)还通过所述第二通孔(12)穿出至所述输送鞘管(10)外，且所述控制线(30)被配置为能够与所述杆(20)相互锁定。
  2. 根据权利要求1所述的可操纵瓣膜夹合系统，其特征在于，所述二尖瓣修复器(40)还包括远端夹片(43)和调节机构，所述调节机构包括传动杆(44)和调节臂(45)，所述传动杆(44)分别穿过所述杆(20)和所述中心座(41)后与所述调节臂(45)连接，所述远端夹片(43)的一端与所述中心座(41)连接，所述远端夹片(43)的另一端与所述调节臂(45)连接。
  3. 根据权利要求2所述的可操纵瓣膜夹合系统，其特征在于，所述第三通孔(21)的孔径等于或略大于所述控制线(30)的线径，位于所述杆(20)内部的所述控制线(30)缠绕在部分所述传动杆(44)上。
  4. 根据权利要求2所述的可操纵瓣膜夹合系统，其特征在于，所述传动杆(44)上开设有键槽(441)，位于所述杆(20)内部的所述控制线(30)穿过所述键槽(441)。
  5. 根据权利要求1所述的可操纵瓣膜夹合系统，其特征在于，所述可操纵瓣膜夹合系统还包括固定套(60)，所述固定套(60)套接于所述杆(20)外侧，所述固定套(60)上开设有用于供所述控制线(30)穿过的开孔(61)，所述控制线(30)与所述杆(20)相互锁定时，所述开孔(61)与所述第三通孔(21)错开。
  6. 根据权利要求5所述的可操纵瓣膜夹合系统，其特征在于，所述固定套(60)上于所述开孔(61)处设置有第一橡胶垫圈。
  7. 根据权利要求5所述的可操纵瓣膜夹合系统，其特征在于，所述杆(20)上设置有外螺纹，所述固定套(60)上设置有内螺纹，所述固定套(60)与所述杆(20)螺纹连接。
  8. 根据权利要求3至7任一项所述的可操纵瓣膜夹合系统，其特征在于，所述杆(20)上于所述第三通孔(21)处设置有第二橡胶垫圈(50)。
  9. 根据权利要求1至7任一项所述的可操纵瓣膜夹合系统，其特征在于，
    所述近端夹片(42)上开设有多个连接孔(421)，所述控制线(30)依次穿过相邻的两个所述连接孔(421)以与所述近端夹片(42)连接。
  10. 根据权利要求1至7任一项所述的可操纵瓣膜夹合系统，其特征在于，
    所述二尖瓣修复器(40)还包括绑线，所述绑线将所述控制线(30)系在所述近端夹片(42)上。
  11. 根据权利要求1至7任一项所述的可操纵瓣膜夹合系统，其特征在于，所述杆(20)上开设有多个所述第三通孔(21)，多个所述第三通孔(21)沿所述杆(20)的轴线方向间隔分布。
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