WO2022127561A1 - 一种带有锁闭机构的瓣膜夹 - Google Patents

一种带有锁闭机构的瓣膜夹 Download PDF

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Publication number
WO2022127561A1
WO2022127561A1 PCT/CN2021/133489 CN2021133489W WO2022127561A1 WO 2022127561 A1 WO2022127561 A1 WO 2022127561A1 CN 2021133489 W CN2021133489 W CN 2021133489W WO 2022127561 A1 WO2022127561 A1 WO 2022127561A1
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WO
WIPO (PCT)
Prior art keywords
locking
arm
clamping arm
valve
clamping
Prior art date
Application number
PCT/CN2021/133489
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English (en)
French (fr)
Inventor
吕世文
陈志�
鲁侃
吴磊
Original Assignee
宁波健世生物科技有限公司
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.)
Filing date
Publication date
Application filed by 宁波健世生物科技有限公司 filed Critical 宁波健世生物科技有限公司
Priority to EP21905490.5A priority Critical patent/EP4245259A1/en
Priority to US18/268,120 priority patent/US20240033084A1/en
Priority to CA3202577A priority patent/CA3202577A1/en
Publication of WO2022127561A1 publication Critical patent/WO2022127561A1/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
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol

Definitions

  • the invention relates to the field of medical instruments, in particular to a valve clip with a locking mechanism.
  • the anatomical structure of the mitral valve is complex, including leaflets, annulus, chordae tendineae and papillary muscles, which play an important role in the maintenance of left and right ventricular function, respectively.
  • Any structurally intact and functional disorder affecting the valve leaflets, annulus, chordae tendineae, papillary muscles, and left ventricle can lead to severe mitral regurgitation (MR), which can lead to left ventricular failure, pulmonary hypertension , atrial fibrillation, stroke and death.
  • mitral regurgitation is the type of valvular disease with the highest incidence in the elderly over 65 years old.
  • Mitral regurgitation can be divided into degenerative MR and functional MR.
  • Degenerative MR is caused by pathological changes in one or more of the valve leaflets, valve annulus, chordae tendineae and papillary muscles; functional MR is usually left ventricular function Abnormalities, such as annulus enlargement, but the mitral valve is usually normal.
  • the treatment methods of MR mainly include drug therapy, surgery and interventional therapy.
  • Drug treatment can only improve the patient's symptoms, but cannot prolong the patient's survival time.
  • Surgery primarily valve repair or valve replacement, is recognized as the treatment of choice for mitral regurgitation and has been shown to relieve symptoms and prolong life.
  • the surgical risk is high and the survival benefit is low.
  • the surgical success rate of such patients is only 50%, and the surgical success rate of patients with severe functional MR is even higher. as low as 16%. Therefore, transcatheter interventional mitral valve repair and replacement could theoretically benefit high-risk patients who have lost the opportunity for surgery.
  • Interventional therapy is to load the artificial implant on the delivery system in vitro, along the vascular path or puncture the apex to deliver the mitral valve annulus, and then release and fix it to completely or partially replace the function of the native valve.
  • mitral valve interventional therapy has become one of the research hotspots in related fields, and many products are under research and development.
  • the development of mitral valve interventional devices faces many special difficulties.
  • Patent CN103826548A provides a method of fixing tissue, the method comprising: providing an implantable fixation device comprising a pair of fixation elements, each fixation element having a first end, a free end opposite the first end and an engagement surface positioned between a first end and a free end to engage tissue, the first ends movably coupled together such that the fixation element can be moved between a closed position and a first open position in which the engagement The surfaces face each other, and in the first open position, the engaging surfaces are positioned away from each other, the patented locking mechanism includes one or more wedge-shaped elements, such as rolling elements; the rolling elements include a pair of barbells arranged on opposite sides of the stud, The barbell is operated by releasing the hooked end of the appliance.
  • the hooked end When an upward force is applied to the appliance through the locking wire, the hooked end resists the spring to raise the barbell and the barbell is pulled up along the side wall or inclined surface, disengaging from the stud. ; By releasing the upward force on the bar by the hooked end, the spring forces the bar downward and wedges the bar between the surface of the instrument and the stud, which restricts the movement of the stud, which in turn locks the braking mechanism and the distal The element is locked in place; the technical defect of the locking mechanism of the MitraClip of the invention is that the design of the locking structure is relatively complex, and the completion of the locking requires rolling elements, springs, locking lines, and the wedge-shaped instrument surface to cooperate with the stud, which requires high assembly technology.
  • the spring is in a state of force and deformation in the initial state, and the locking wire returns to its original state after release, so the locking structure is not reversible. If an operation error occurs during the operation and the valve clamping is not completed, the locking mechanism cannot be unlocked, that is It means that the operation fails; the implanted device will remain in the body after the operation, and the spring will be fatigued after being stressed for a long time, which will affect the clamping force of the valve leaflets, so the unlocking mechanism has potential safety hazards.
  • Patent CN201880066104.9 discloses a valveable clip device including a spacer member configured to be disposed between leaflets of a native heart valve located between a first chamber and a second chamber of the heart.
  • the prosthetic device further includes a plurality of anchor members coupled to the spacer member and configured to capture the leaflets between the respective anchor members and the spacer member such that the prosthetic device are held between the leaflets.
  • the spacer member is configured to provide a flow path through the prosthetic device between the first lumen and the second lumen such that blood can pass through the spacer member from the The second cavity flows back to the first cavity; the technical solution of this patent uses pre-shaped metal material to clamp and fix the native valve leaflet.
  • the purpose of the present invention is to provide a valve clip with a locking mechanism, the valve clip has the following advantages: simple structure, low requirements for assembly process, and can maintain clamping force for a long time;
  • a valve clip with a locking mechanism comprising a first clamping arm, a second clamping arm, a connecting piece, a push-pull device and a locking device
  • the locking device partially cooperates with the engaging piece
  • the locking device includes a locking head and a self-locking rod
  • the engaging piece is hinged with the first clamping arm and the second clamping arm, respectively
  • the clamping arm includes a long arm and short arm, one end of the long arm is hingedly connected with the push-pull device, one end of the short arm is provided with a locking part
  • the push-pull device is operated to make the long arm of the first clamping arm and the second clamping arm
  • the opening angle of the long arm becomes larger and is in the open state
  • the locking part on the first clamping arm and the locking part on the second clamping arm are partially in a dislocation matching state
  • operating the push-pull device makes the first When the opening angle of the long arm of the clamping arm and
  • a locking area is formed between the locking portion and the engaging piece, and the size of the locking area varies with the opening angle of the clamping arm.
  • the locking area gradually becomes larger, and when the locking head enters the locking area and completes locking cooperation with the locking portion, the valve clip is locked.
  • a biasing structure is provided on the long arm, and the biasing structure divides the long arm into a fitting part and a transmission part, when the long arm of the first clamping arm and the second When the opening angle of the long arm of the clamping arm is reduced to be in the closed state, the fitting portion is located closer to the central axis of the valve clamp than the transmission portion.
  • a rotation structure is provided between the self-locking rod and the locking head, so that the self-locking rod and the locking head can rotate relative to each other.
  • the engaging piece includes an engaging block and a connecting lug provided on the engaging block, the engaging block is connected with the locking device, and the connecting lugs are respectively connected with the first clamping arm and the second clamping arm.
  • the clamp arm is hinged.
  • the engaging piece is an arc-shaped structure or a "V"-shaped structure; the purpose of this design is to shorten the loading length of the valve clip during pre-assembly.
  • the connecting lugs are axially symmetrical about the axis of the engaging block.
  • the engaging block is provided with an installation groove, and at least part of the locking head is always arranged in the installation groove, and the installation groove restricts the circumferential rotation of the locking head; the purpose of this design is: When the locking head is set as a special-shaped structure, during the process of operating the self-locking lever to move the locking head axially to the locking part, the installation groove restricts the circumferential rotation of the locking head, so that the locking head enters the locking according to the predetermined position. area and complete the fit with the locking part.
  • a through hole is axially provided on the engaging block, and the installation groove is provided on the distal end side of the through hole.
  • the locking head is restricted from moving toward the proximal end by the mounting groove, and the diameter of the mounting groove is larger than the diameter of the through hole.
  • the self-locking rod is solid or hollow.
  • the locking head when the locking area formed by the locking portion is a wedge-shaped structure or the locking area is a tapered structure, the locking head is correspondingly set to a wedge-shaped structure or a tapered structure; When the heads are wedge-shaped or tapered, the locking force is stronger, and the valve clamp is more stable and reliable.
  • the locking head is a stent-shaped self-expanding structure, and the locking head cooperates with the locking portion to achieve locking.
  • the locking head has a cone-shaped structure or a shuttle-shaped structure or a diamond-shaped structure or a prismatic structure or an arrowhead-shaped structure.
  • the locking head is hollow, the locking head is made of elastic metal material, and a hollow area is formed inside the locking head, which is a buffer area.
  • the clamping arm will be subject to a certain amount of stress, which will affect the clamping degree between the clamping arm and the pushing device, resulting in a certain degree of regurgitation.
  • the locking head is made of elastic metal material, And a buffer area is formed inside the locking head, so that the long arm of the clamping arm is transmitted to the short arm by the stress caused by the movement of the valve itself, and then the force received by the short arm is transmitted to the locking head, and the locking head is deformed to a certain extent. The stress is decomposed, and the clamping force and tightness between the clamping arm and the pushing device are always guaranteed, so as to avoid backflow.
  • the shape of the short arm is an arc or "L" shape, and when the opening angles of the first clamping arm and the second clamping arm become larger, the The locking portion and the locking portion on the second clamping arm are in dislocation fit; the locking portion is designed as an arc segment or an "L" shape, which is beneficial to increase the force arm of the locking portion and enhance the locking force. At the same time, the locking portion The way of dislocation matching between them is beneficial to save the loading space.
  • the connecting piece is provided with an anti-return device that cooperates with the self-locking rod; the anti-return device can enhance the stability of the locking device and ensure the locking effect for a long time.
  • the anti-backoff device is a thread or a groove.
  • the push-pull device includes a valve leaflet catching device, a leak-proof pipe, and a first linkage rod and a second linkage rod hinged to the leak-proof pipe and arranged on the left and right sides of the leak-proof pipe.
  • the linkage rod and the second linkage rod are respectively hinged with the first clamping arm and the second clamping arm, and the valve leaflet catching device is arranged on the first linkage rod and the second linkage rod, and the valve leaflet is arranged on the first and second linkage rods.
  • the catching device has a preset shape. In a natural state, the valve leaflet catching device is close to the linkage rod. During pre-installation, the valve leaflet catching device always fits the leak-proof tube. When the valve When the clip captures the valve leaflet, the valve leaflet capture device restores a preset configuration to grip the valve leaflet.
  • valve leaflet catching device can be individually controlled to clamp and anchor a single valve leaflet, so as to reduce the difficulty of operation.
  • the locking portion includes a plurality of arc-shaped struts distributed in a comb shape, and when the opening angle of the first clamping arm and the second clamping arm increases, the first clamping arm There is a dislocation fit between the arc-shaped strut on the second clamping arm and the arc-shaped strut on the second clamping arm; multiple arc-shaped struts distributed in a comb shape help to increase the action point of the short arm force, Make the lock more stable and reliable.
  • the end of the arc-shaped strut is bent inward, and the end of the arc-shaped strut is locked toward the locking when the first clamping arm and the second clamping arm are closed.
  • the device provides a force point.
  • the cross-section of the long arm is in a concave shape; the purpose of this design is: when the valve is clamped in a closed state, the long arm has a certain wrapping effect on the leak-proof tube, making it more leak-proof.
  • the setting of the concave shape also greatly reduces the weight of the long arm, which can effectively prevent the valve clip from slipping in the heart due to excessive weight, which is beneficial to the stability of the valve clip anchored in the heart, and will not affect the original valve leaflet. Excessive tearing and damage to the heart tissue.
  • the end of the long arm connected to the push-pull device is provided with a circular arc buffer section; the advantage of this design is that when the valve is clamped to capture the valve leaflets and complete the clamping, the circular arc buffer section can protect the valve The native leaflets are protected from damage.
  • the clamping arm is provided with a fitting structure at the hinge point; the advantage of designing the fit structure is that the short arm drives the long arm with the hinge point lever, so when locking, the force at the hinge point is relatively high. Large, fit structure can increase the contact surface with the connecting piece, making the locking torque more balanced.
  • the push-pull device when the push-pull device is operated to make the opening angle of the long arm of the first clamping arm and the long arm of the second clamping arm become larger and open, the first clamping
  • the locking part on the arm and the locking part on the second clamping arm are partially in a dislocation matching state, which will not interfere/affect the size of the opening angle between the clamping arms, which is conducive to capturing and clamping the valve leaflets.
  • move the locking device so that the locking head and the locking portion are matched and locked that is, the locking is completed; using the lever principle, a moment balance is generated between one end of the locking device and the locking portion, and the first clamping is controlled.
  • the opening angle of the arm and the second clamping arm is no longer increased to achieve the effect of locking.
  • the locking structure is mechanical locking, which is simple in structure, easy to operate without risk of fatigue, and can ensure the clamping effect for a long time;
  • the shape of the short arm of the present invention is an arc or "L" shape, and the purpose of this design is: the arc segment can increase the force arm of the locking portion, thereby ensuring the locking force of the valve clamp, It makes the locking state of the valve clip more stable and reliable, and at the same time, the dislocation matching method is beneficial to save the loading space;
  • the connecting piece is provided with an installation groove, at least part of the locking head is always arranged in the installation groove, and the installation groove restricts the circumferential rotation of the locking head; the purpose of this design is: when the locking head is set In the case of a special-shaped structure, during the process of operating the self-locking lever to move the locking head axially to cooperate with the locking part, the installation groove restricts the circumferential rotation of the locking head, so that the locking head enters the locking area according to the predetermined position and completes the cooperation with the locking part.
  • the installation groove of the connecting piece can reduce the weight of the valve clip, effectively prevent the valve clip from slipping in the heart due to excessive weight, and is conducive to the stability of the valve clip anchoring in the heart;
  • the cross section of the long arm is a concave shape; the purpose of this design is: when the valve is clamped in the closed state, the long arm has a certain wrapping effect on the leak-proof pipe fittings, making the leak-proof effect more effective.
  • the setting of the concave shape also greatly reduces the weight of the long arm, which can effectively prevent the valve clip from slipping in the heart due to excessive weight, which is beneficial to the stability of the valve clip anchored in the heart, and will not affect the original valve leaflet. Excessive tearing and damage to the heart tissue;
  • the locking head of the present invention is a stent-shaped self-expanding structure, and a hollow area is formed inside the locking head, which is a buffer area.
  • the relaxation will cause the clamping arm to be subjected to a certain stress, which will affect the degree of clamping between the clamping arm and the pushing device, resulting in a certain degree of backflow.
  • the locking head is made of elastic metal material, and a buffer area is formed inside the locking head , so that the long arm of the clamping arm is transmitted to the short arm by the stress caused by the movement of the valve itself, and then the force received by the short arm is transmitted to the locking head.
  • the clamping force and tightness between the closing arm and the pushing device to avoid reflux;
  • the present invention is provided with a biasing structure, and the biasing structure makes the opening angle of the long arm of the first clamping arm and the long arm of the second clamping arm become smaller when they are in a closed state.
  • the fitting part is located closer to the central axis of the valve clip, so that when the valve clip is closed, the long arm can be close to the leak-proof tube, which further ensures the closure of the valve clip It also improves the leakage prevention effect.
  • FIG 1a to 1d are schematic diagrams of the process of locking the valve clamp of the present invention.
  • FIGS. 2a-2h are schematic structural diagrams of a clamping arm, a locking portion and an arc-shaped support rod according to the present invention.
  • FIGS. 3c to 3g are schematic structural diagrams of the locking device and the locking block of the present invention, wherein FIGS. 3c to 3g are various embodiments of the locking block.
  • 4a-4d are schematic structural diagrams of the connecting piece of the present invention.
  • 5a-5b are schematic diagrams of the process of disassembling the delivery catheter and the valve clip according to the present invention.
  • 6a-6g are schematic diagrams of the process of entering the heart with the delivery catheter of the present invention.
  • Figures 7a-7c are schematic diagrams of the process of opening the valve in the left atrium by clipping of the present invention.
  • Figures 8a-8h are schematic diagrams of the process of moving the valve clip according to the present invention to the optimal position for capturing the valve.
  • 9a-9c are another embodiment of the locking device of the present invention for locking the valve clip.
  • Figures 10a-10c are another embodiment of the locking device of the locking valve clip of the present invention.
  • 11a-11g are another embodiment of the locking device of the present invention for locking the valve clip.
  • proximal end in the present invention refers to the end close to the operator, and the distal end refers to the end away from the operator.
  • a valve clip with a locking mechanism When used for the treatment of mitral valve disease, as shown in Figures 1a to 1d, a valve clip with a locking mechanism includes a first clipping arm 1, a second clipping arm 2, an engaging piece 3, a push-pull A device 9 and a locking device 4, the locking device 4 partially cooperates with the engaging member 3, the locking device 4 includes a locking head 41 and a self-locking rod 42, and the engaging member 3 is respectively connected with the first clamping arm 1 and the second clamping arm 2 are hinged, the clamping arm includes a long arm 12 and a short arm 11, one end of the long arm 12 is hingedly connected with the push-pull device 9, and one end of the short arm 11 is provided with a locking Part 111, when the push-pull device 9 is operated to make the opening angle of the long arm 12 of the first clamping arm 1 and the long arm 12 of the second clamping arm 2 increase to be in an open state, the first clamping arm 1 The locking portion 111 and the locking portion 111 on the second clamp
  • a locking area 33 is formed between the locking portion 111 and the connecting piece 3 , and the size of the locking area 33 changes with the opening angle of the clamping arm.
  • the opening angles of the clamping arm 1 and the second clamping arm 2 become smaller, the locking area 33 gradually becomes larger, and when the locking head 41 enters the locking area 33 and completes the locking cooperation with the locking portion 111 , the The valve clip is locked as shown in Figures 2e and 2f.
  • the long arm 12 is provided with a biasing structure 122.
  • the biasing structure 122 and the biasing structure 122 divide the long arm 12 into a fitting portion 123 and a transmission portion.
  • the abutting part 124 123 is located closer to the central axis of the valve clamp; the advantage of this design is that when the valve clamp is in a closed state, the long arm 12 can be close to the push-pull device 9, further increasing the clamping effect, while lifting Anti-leakage function.
  • the locking portion 111 includes an arcuate segment 1111. As shown in FIGS. 2a and 2b, when the opening angles of the first clamping arm 1 and the second clamping arm 2 increase, the first clamping arm 1 and the second clamping arm 2 The arc-shaped segment 1111 on the clamping arm 1 and the arc-shaped segment 2111 on the second clamping arm 2 are dislocated and buckled; The locking force is enhanced, and at the same time, the dislocation buckle method is beneficial to save the loading space; similarly, the locking portion 111 can also be set in an "L" shape, as shown in Fig. 2g.
  • the locking portion 111 includes a plurality of arc-shaped support rods 1112. As shown in FIG. 2c, when the opening angle of the first clamping arm 1 and the second clamping arm 2 increases, the first clamping arm 1 and the second clamping arm 2 The arc-shaped support rod 1112 on the first clamping arm 1 and the arc-shaped support rod 1112 on the second clamping arm 2 are dislocated and buckled; the plurality of arc-shaped support rods 1112 help to increase the force of the short arm 11 The action point makes the locking more stable and reliable.
  • the first clamping arm 1 has three arc-shaped struts 1112
  • the second clamping arm 2 has two arc-shaped struts 2112, as shown in Figs.
  • the end of the arc-shaped support rod 1112 touches the locking head 41 .
  • the clamping arm is provided with a fitting structure 13 at the hinge point, as shown in FIG. 2c ;
  • the advantage of designing the fitting structure 13 is that the short arm 11 drives the long arm 12 with the hinge point lever, so the When locking, the force at the hinge point is relatively large, and the fitting structure 13 can increase the contact surface with the connecting piece 3, so that the locking moment is more balanced.
  • the locking device 4 includes a locking head 41 and a self-locking rod 42, as shown in Figures 3a and 3b; the locking head 41 and the locking portion 111 on the short arm 11 are trapezoidal fit or wedge fit Or taper fit, round fit or cube fit, as shown in Figures 3c to 3g.
  • the engaging piece 3 includes an engaging block 31 and a connecting lug 32 provided on the engaging block 31. As shown in FIGS. 4a and 4b, the engaging block 31 is connected to the locking device 4, and the connection The ears 32 are hinged with the first and second clamping arms 1 and 2, respectively.
  • the connecting piece 3 may be an arc-shaped structure or a "V"-shaped structure, as shown in Figures 4c and 4d; the purpose of this design is to shorten the loading length of the valve clip during pre-assembly.
  • the connecting piece 3 is provided with an anti-return device 34 that cooperates with the self-locking rod 42 ; the anti-return device 34 can enhance the stability of the locking device 4 and ensure the locking effect for a long time.
  • the anti-backoff device 34 is a thread or a groove.
  • the push-pull device 9 includes a leaflet catching device 91 , a leak-proof pipe 5 , and a first linkage rod 6 and a second linkage rod hinged to the leak-proof pipe 5 and arranged on the left and right sides of the leak-proof pipe 5 . 7.
  • the first linkage rod 6 and the second linkage rod 7 are hinged with the first clamping arm 1 and the second clamping arm 2 respectively, and the leaflet catching device 91 is arranged on the first linkage rod.
  • the valve leaflet catching device 91 has a preset shape, in a natural state, the valve leaflet catching device 91 is close to the linkage rod, when pre-installed, the valve leaflet catches The catching device 91 is always attached to the leak-proof tube 5 , and when the valve clip captures the valve leaflet, the valve leaflet catching device 91 restores a preset shape to hold the valve leaflet.
  • the end of the long arm 12 connected to the push-pull device 9 is provided with a circular arc buffer section 121.
  • the The arc buffer section 121 can protect the original valve leaflet from being damaged.
  • the cross section of the long arm 12 is in a concave shape; the purpose of this design is: when the valve is clamped in the closed state, the long arm 12 has a certain wrapping effect on the leak-proof pipe 5, so that the leak-proof effect is better.
  • the setting of the concave shape also greatly reduces the weight of the long arm 12, effectively preventing the valve clip from slipping in the heart due to excessive weight, which is beneficial to the stability of the valve clip anchoring in the heart, and will not affect the original valve leaflet. Excessive tearing occurs and damage to the heart tissue.
  • the valve clip further includes a valve clip delivery system
  • the valve clip delivery system includes a control handle and a delivery catheter 8 connected to the control handle.
  • the distal end of the delivery catheter 8 is The end part is detachably connected with the valve clip.
  • the delivery catheter 8 is connected with the valve clip.
  • the delivery catheter 8 is connected with the valve clip. separable.
  • the working principle of the present invention is:
  • valve clip delivery catheter 8 Operate the valve clip delivery catheter 8 from the inferior vena cava into the heart, and then operate the delivery catheter 8 to make the valve clip pass through the atrial septum, as shown in Figures 6a-6e; continue to operate the delivery catheter 8 to bend so that all The valve clip is facing the mitral valve, as shown in Figures 6f and 6g;
  • control handle Operate the control handle to clamp the valve leaflet so that the front valve part and the rear valve part enter the valve leaflet catching device 91, and are respectively fixed between the leak-proof pipe 5 and the first linkage rod 6 and the leak-proof part. Between the pipe 5 and the second linkage rod 7;
  • a valve clip with a locking mechanism includes a first clipping arm 1, a second clipping arm 2, an engaging member 3 and a locking device 4, so The locking device 4 is connected with the engaging piece 3, and the engaging piece 3 is hinged with the first clamping arm 1 and the second clamping arm 2 respectively, and the clamping arm includes a long arm 12 and a short arm 11, The short arm 11 drives the long arm 12 with a hinge point lever, and one end of the short arm 11 is provided with a locking portion 111.
  • the opening angles of the first clamping arm 1 and the second clamping arm 2 become larger , the locking portion 111 on the first clamping arm 1 and the locking portion 111 on the second clamping arm 2 are dislocated and buckled.
  • a locking area 33 is formed between the locking portion 111 and the engaging member 3, and one end of the locking device 4 enters the locking area 33 and completes the locking cooperation with the locking portion 111;
  • the valve clip also includes a push-pull device 9, which includes a valve leaflet catching device 91, a leak-proof pipe 5, and a first linkage rod 6 hinged to the leak-proof pipe 5 and arranged on the left and right sides of the leak-proof pipe 5. and the second linkage rod 7, the first linkage rod 6 and the second linkage rod 7 are hinged with the first clamping arm 1 and the second clamping arm 2 respectively, and the leaflet catching device 91 is provided at the On the first linkage rod 6 and the second linkage rod 7, the valve leaflet catching device 91 has a preset shape, and in a natural state, the valve leaflet catching device 91 is close to the linkage rod.
  • the valve leaflet catching device 91 always fits the leak-proof tube 5 , and when the valve clip captures the valve leaflet, the valve leaflet catching device 91 restores to a preset shape to hold the valve leaflet.
  • the locking device 4 is connected with the connecting piece 3 by a screw thread, and the locking device 4 cannot rotate without external force in the heart, so the locking device 4 abuts against the first locking portion 111 and the first locking portion 111 and the first locking portion 111.
  • the first locking part 111 and the second locking part 211 are respectively supported by opposite radial directions from the locking device 4 , as shown in FIG.
  • the clamping arm 1 obtains a radial support force toward the left
  • the second clamping arm 2 obtains a radial support force toward the right
  • the locking portion 111 includes an arc-shaped segment 1111 .
  • the arc-shaped section on the first clamping arm 1 becomes larger.
  • the segment 1111 and the arc-shaped segment 2111 on the second clamping arm 2 are misaligned and buckled; the locking portion 111 is designed as an arc-shaped segment 1111, which is beneficial to increase the force arm of the locking portion 111 and enhance the locking force.
  • the way of staggered buckle is beneficial to save the loading space.
  • the lengths of the first arc-shaped strut 1112 and the second arc-shaped strut 2112 are changed compared with the previous embodiment.
  • the locking head 41 on the locking device 4 is arranged in a conical structure, and the locking head on the locking device 4
  • the diameter of the proximal portion 41 is greater than the distance between the end of the first arc-shaped strut 1112 and the end of the second arc-shaped strut 2112, and the locking device 4 is operated to make the distal portion of the locking head 41 enter/ Passing through the hole between the first arc-shaped support rod 1112 and the second arc-shaped support rod 1112, and at the same time, the locking head 41 is also connected to the first arc-shaped support rod 1112 and the second arc-shaped support rod. 1112 interfere with each other for the purpose of locking, as shown in Figures 9b and 9c.
  • a valve clip with a locking mechanism includes a first clipping arm 1, a second clipping arm 2, an engaging member 3 and a locking device 4, so The locking device 4 is connected with the connecting piece 3, the locking device 4 includes a locking head 41 and a self-locking rod 42, and the connecting piece 3 is hinged with the first clamping arm 1 and the second clamping arm 2 respectively , the clamping arm includes a long arm 12 and a short arm 11, the short arm 11 drives the long arm 12 with a hinge point lever, and one end of the short arm 11 is provided with a locking part 111, the first clamping When the opening angle of the arm 1 and the second clamping arm 2 increases, the locking portion 111 on the first clamping arm 1 and the locking portion 111 on the second clamping arm 2 are dislocated and buckled, so When the opening angles of the first clamping arm 1 and the second clamping arm 2 become smaller, a locking area 33 is formed between the locking portion 111 and the connecting piece 3 , and one end
  • the valve clip also includes a push-pull device 9, which includes a valve leaflet catching device 91, a leak-proof pipe 5, and a first linkage rod 6 hinged to the leak-proof pipe 5 and arranged on the left and right sides of the leak-proof pipe 5. and the second linkage rod 7, the first linkage rod 6 and the second linkage rod 7 are hinged with the first clamping arm 1 and the second clamping arm 2 respectively, and the leaflet catching device 91 is provided at the On the first linkage rod 6 and the second linkage rod 7, the valve leaflet catching device 91 has a preset shape. In a natural state, the valve leaflet catching device 91 is close to the linkage rod. The valve leaflet catching device 91 is always attached to the leak-proof tube 5 , and when the valve clip captures the valve leaflet, the valve leaflet catching device 91 restores a preset shape to hold the valve leaflet.
  • a push-pull device 9 which includes a valve leaflet catching device 91, a leak-
  • the self-locking rod 42 and the connecting piece 3 are threadedly connected, and the locking device 4 cannot be rotated without external force in the heart, so the locking head 41 abuts against the first locking portion 111 and the After the second locking portion 211 cannot move axially, the first locking portion 111 and the second locking portion 211 are respectively supported by opposite radial directions from the locking head 41. As shown in FIG.
  • the locking head 41 is a stent-shaped self-expanding structure, and the locking head 41 cooperates with the locking portion 111 to achieve locking.
  • the locking head 41 may have a conical structure, a shuttle-shaped structure, a diamond-shaped structure, a prismatic structure or an arrowhead-shaped structure, and the distal portion of the locking head 41 is a conical structure.
  • the locking head 41 is arranged in a diamond-shaped structure, the locking head 41 is hollow, the locking head 41 is made of elastic metal material, and a hollow area is formed inside the locking head 41, which is a buffer area,
  • the locking head 41 is made of elastic metal material, and a buffer area is formed inside the locking head 41, the long arm 12 of the clamping arm is transmitted to the short arm 11 by the stress caused by the movement of the valve itself, and then the force received by the short arm 11 is transmitted to the short arm 11.
  • the locking head 41 is deformed to a certain extent, and the stress on it is decomposed, and the clamping force and tightness between the clamping arm and the push-pull device 9 are always ensured, so as to avoid backflow.
  • the locking portion 111 includes a plurality of arc-shaped support rods 1112 .
  • the first clamping arm 1 will The arc-shaped struts 1112 of the second clamping arm 2 and the arc-shaped struts 2112 on the second clamping arm 2 are dislocated and buckled; the multiple arc-shaped struts 1112 help to increase the action point of the short arm 11, so that the locking More stable and reliable.
  • a valve clip with a locking mechanism includes a first clipping arm 1, a second clipping arm 2, an engaging member 3 and a locking device 4, so The locking device 4 is connected with the connecting piece 3, the locking device 4 includes a locking head 41 and a self-locking rod 42, and the connecting piece 3 is hinged with the first clamping arm 1 and the second clamping arm 2 respectively , the clamping arm includes a long arm 12 and a short arm 11, the short arm 11 drives the long arm 12 with a hinge point lever, and one end of the short arm 11 is provided with a locking part 111, the first clamping When the opening angle of the arm 1 and the second clamping arm 2 increases, the locking portion 111 on the first clamping arm 1 and the locking portion 111 on the second clamping arm 2 are dislocated and buckled, so When the opening angles of the first clamping arm 1 and the second clamping arm 2 become smaller, a locking area 33 is formed between the locking portion 111 and the connecting piece 3 , and one end of
  • the valve clip also includes a push-pull device 9, which includes a valve leaflet catching device 91, a leak-proof pipe 5, and a first linkage rod 6 hinged to the leak-proof pipe 5 and arranged on the left and right sides of the leak-proof pipe 5. and the second linkage rod 7, the first linkage rod 6 and the second linkage rod 7 are hinged with the first clamping arm 1 and the second clamping arm 2 respectively, and the leaflet catching device 91 is provided at the On the first linkage rod 6 and the second linkage rod 7, the valve leaflet catching device 91 has a preset shape, and in a natural state, the valve leaflet catching device 91 is close to the linkage rod.
  • the valve leaflet catching device 91 always fits the leak-proof tube 5 , and when the valve clip captures the valve leaflet, the valve leaflet catching device 91 restores to a preset shape to hold the valve leaflet.
  • a rotating structure 43 is provided between the self-locking rod 42 and the locking head 41 , so that the self-locking rod 42 and the locking head 41 can rotate relative to each other, as shown in FIG. 11d .
  • the rotating structure 43 includes a groove 431 and a boss 432 , the groove 431 is provided at the proximal end of the locking head 41 , and the boss 432 is provided at the far end of the self-locking rod 42 . At the end, the groove 431 is matched with the boss 432, as shown in FIG. 11d.
  • the connecting piece 3 is provided with an installation groove 312, and at least part of the locking head 41 is always disposed in the installation groove 312, and the installation groove 312 restricts the circumferential rotation of the locking head.
  • the shape of the mounting groove 312 matches the shape of the locking head 41
  • the locking head 41 has a tapered structure, or a wedge-shaped structure, a shuttle-shaped structure, or an arrowhead-shaped structure, as shown in FIGS. 11e to 11g .
  • the connecting piece 3 includes a connecting block 31 and a connecting lug 32 disposed on the connecting block 31 , the connecting block 31 is connected to the locking device 4 , and the connecting lugs 32 are respectively connected to the first connecting lugs 32 .
  • the clamping arm 1 and the second clamping arm 2 are hingedly connected, and a through hole 311 and an installation groove 312 are axially provided on the connecting block 31, and the installation groove 312 is disposed on the distal side of the through hole 311; the connecting piece 3.
  • the installation groove 312 can reduce the weight of the valve clip, effectively prevent the valve clip from slipping in the heart due to excessive weight, and is beneficial to the stability of the valve clip anchored in the heart.
  • the connecting ears 32 are symmetrical with respect to the central axis of the engaging block 31 .
  • the engaging block 31 is provided with an installation groove 312, and at least part of the locking head 41 is always disposed in the installation groove 312.
  • the installation groove 312 restricts the circumferential rotation of the locking head 41.
  • the locking head 41 is completely located in the installation groove 312, the loading space can be saved.
  • part of the locking head 41 is still in the installation groove 312.
  • the purpose of this design is: when the locking head 41 is set to a special-shaped structure, the self-locking lever 42 is operated to make the locking head 41 move axially to the process of locking with the locking portion 111, and the mounting groove 312 restricts the locking head 41. Rotate in the circumferential direction, so that the locking head 41 enters the locking area 33 according to the predetermined position and completes the cooperation with the locking part.
  • the installation groove 312 is disposed on the distal end side of the through hole 311 .
  • the locking head 41 is restricted from moving toward the proximal end by the installation groove 312 , and the diameter of the installation groove 312 is larger than the diameter of the through hole 311 .

Abstract

一种带有锁闭机构的瓣膜夹，包括第一夹合臂（1）、第二夹合臂（2）、衔接件（3）、推拉装置（9）和锁定装置（4），锁定装置（4）与衔接件（3）配合，锁定装置（4）包括锁定头（41）和自锁杆（42），衔接件（3）分别与第一夹合臂（1）和第二夹合臂（2）铰接，第一、第二夹合臂（1、2）分别包括长臂（12）和短臂（11），长臂（12）的一端与推拉装置（9）铰链连接，短臂（11）的一端设置有锁定部（111），操作推拉装置（9）使第一夹合臂（1）的长臂（12）和第二夹合臂（2）的长臂（12）张角变大呈张开状态时，第一夹合臂（1）上的锁定部（111）与第二夹合臂（2）上的锁定部（111）呈错位配合状态；操作推拉装置（9）使第一夹合臂（1）的长臂（12）和第二夹合臂（2）的长臂（12）张角变小呈闭合状态时，移动锁定装置（4）使得锁定头（41）与锁定部（111）实现配合并锁定。

Description

一种带有锁闭机构的瓣膜夹
本申请要求于2020年12月18日在中国提交的申请号为202011511245.2的中国发明专利申请“一种带有锁闭机构的瓣膜夹”的优先权，该中国申请的全部内容通过引用结合于本申请中。
技术领域
本发明涉及医疗器械领域，尤其涉及一种带有锁闭机构的瓣膜夹。
背景技术
二尖瓣解剖结构复杂，包含瓣叶、瓣环、腱索与乳头肌，分别对左、右心室功能的维持起着重要作用。任何影响到瓣叶、瓣环、腱索、乳头肌和左心室的结构完整和功能正常的疾病都可能导致严重的二尖瓣关闭不全(mitral regurgitation，MR)，可引起左心室衰竭、肺动脉高压、心房颤动、脑卒中和死亡。根据美国等西方发达国家的最新流行病学调查数据显示，在大于65岁以上的老年人群发病率占首位的瓣膜病类型是二尖瓣反流。目前，我国虽然还没有权威性的流行病学调查数据，但随着人口老龄化的来临，我国二尖瓣反流患者的数量之庞大是毋庸置疑的。二尖瓣关闭不全可分退行性MR和功能性MR,退行性MR是由瓣叶、瓣环、腱索和乳头肌的1项或以上发生病理学改变引起；功能性MR通常为左心室功能异常，例如瓣环扩大，但二尖瓣瓣膜通常是正常的。
目前，MR的治疗方法主要包括药物治疗、外科手术及介入治疗。药物治疗只能改善患者症状，不能延长患者生存时间。外科手术主要是瓣膜修复术或瓣膜置换术，被公认为是二尖瓣反流的首选治疗方法，已被证实能缓解患者的症状及延长其寿命。然而对于很多高龄合并多系统疾病的高危患者，手术风险高，生存获益少，根据欧洲数据显示，此类患者的外科手术成功率仅50％，重度功能性MR患者的外科手术成功率更是低至16％。因此，经导管介入二尖瓣修复及置换理论上可使失去外科手术机会的高危患者获益。介入治疗是将人工植入物在体外装载至输送系统上，沿血管路径或穿刺心尖送达二尖瓣瓣环处，然后释放并固定以完全或部分替代自体瓣膜的功能。当前，二尖瓣介入治疗已成为相关领域研究的热点之一，众多产品均在研发中。但因二尖瓣本身及周边结构复杂等问题，二尖瓣介入器械的发展面临许多特殊困难。
专利CN103826548A提供一种固定组织的方法，所述方法包括：提供可植入固定装置，其包括一对固定元件，每个固定元件具有第一端部、与第一端部相对的自由端部和位于第一端部和自由端部之间以结合组织的接合表面，第一端部可动地联接在一起，使得固定元件能够在闭合位置和第一打开位置之间运动，在闭合位置，接合表面彼此面对，在第一打开位置，接合表面彼此远离定位，该专利锁定机构包括一个或多个楔形元件，例如滚动元件；滚动元件包括布置在螺柱的相对侧上的一对杠铃件，杠铃件通过释放器具的带钩端操作，在向上的力通过锁定线施加到器具时，带钩端抵抗弹簧使杠铃件升高，杠铃件沿着侧壁或倾斜表面向上拉动，与螺柱解脱；通过带钩端释放杠铃件上的向上的力，弹簧迫使件向下，并将杠铃件楔入器械表面与螺柱之间，这限制了螺柱的运动，继而将制动机构以及远侧元件锁定就位；该发明的MitraClip的锁定机构的技术缺陷在于：锁定结构设计相对复杂，完成锁定需要滚动元件、弹簧、锁定线、位于楔形的器械表面与螺柱相配合，对装配工艺要求高；弹簧在初始状态处于受力变形状态，锁定线释放后恢复原状，故锁定结构不存在可逆性，若在手术过程中且未 完成瓣膜夹持便出现操作失误，该锁定机构无法进行解锁，即意味着手术失败；术后植入器械留存体内，弹簧长时间受力会出现疲劳，从而影响瓣叶夹合力，故该解锁机构存在安全隐患。
专利CN201880066104.9公开了一种可瓣膜夹装置包括间隔件构件，间隔件构件被配置为被布置在位于心脏的第一腔和第二腔之间的天然心脏瓣膜的小叶之间。假体装置进一步包括多个锚定部构件，多个锚定部构件被耦接至间隔件构件并被配置以将小叶捕获在各自的锚定部构件和间隔件构件之间，使得假体装置被保持在小叶之间。当小叶被捕获在锚定部构件和间隔件构件之间时，间隔件构件被配置以提供在第一腔和第二腔之间通过假体装置的流动路径，使得血液可以通过间隔件构件从第二腔反流地流到第一腔；该专利的技术方案采用预塑型金属材料对原生瓣叶进行夹持固定，虽然简化了其传动系统，但由于没有可靠的锁定装置，同时心脏在不停的进行收缩与舒张，使得原生瓣叶容易从间隔件构件与锚定部构件之间滑脱，其次，采用预塑型金属材料对原生瓣叶进行夹持固定容易发生疲劳损伤，影响其使用寿命。
综上所述，由于现有技术中的锁定结构设计相对复杂，对装配工艺要求极高，弹片时间长会出现疲劳而影响夹合力，因此需要结构设计相对简化、装配便捷且能长时间保持夹合力的锁闭机构。
发明内容
本发明的目的是提供一种带有锁闭机构的瓣膜夹，该瓣膜夹具备以下优点：结构简单，对装配工艺要求低，又能长时间保持夹合力；
为了解决上述技术问题，本发明提供了下述技术方案：一种带有锁闭机构的瓣膜夹，包括第一夹合臂、第二夹合臂、衔接件、推拉装置和锁定装置，所述锁定装置部分与所述衔接件配合，所述锁定装置包括锁定头和自锁杆，所述衔接件分别与所述第一夹合臂和第二夹合臂铰接，所述夹合臂包括长臂和短臂，所述长臂的一端与所述推拉装置铰链连接，所述短臂的一端设置有锁定部，操作推拉装置使所述第一夹合臂的长臂和第二夹合臂的长臂张角变大呈张开状态时，所述第一夹合臂上的锁定部与所述第二夹合臂上的锁定部部分呈错位配合状态；操作推拉装置使所述第一夹合臂的长臂和第二夹合臂的长臂张角变小呈闭合状态时，移动所述锁定装置使得所述锁定头与所述锁定部实现配合并锁定。
本发明还可以通过以下技术方案进一步实现：
在一个实施方式中，所述锁定部与所述衔接件之间形成有锁定区域，所述锁定区域的大小随所述夹合臂的张角变化而变化，当所述第一夹合臂和第二夹合臂的张角变小时，所述锁定区域逐步变大，所述锁定头进入所述锁定区域并与所述锁定部完成锁定配合时，所述瓣膜夹即被锁定。
在一个实施方式中，所述长臂上设有偏置结构，所述偏置结构将所述长臂分为贴合部和传动部，当所述第一夹合臂的长臂和第二夹合臂的长臂张角变小呈闭合状态时，相比于所述传动部，所述贴合部位于更靠近所述瓣膜夹的中轴线的位置。
在一个实施方式中，所述自锁杆与所述锁定头之间设置有转动结构，使得所述自锁杆与所述锁定头之间能够相对转动。
在一个实施方式中，所述衔接件包括衔接块以及设置在衔接块上的连接耳，所述衔接块与所述锁定装置连接，所述连接耳分别与所述第一夹合臂和第二夹合臂铰接。
在一个优选的实施方式中，所述衔接件为弧形结构或＂V＂形结构；这样设计的目的在于：预装时可以缩短瓣膜夹的装载长度。
在一个优选的实施方式中，所述连接耳关于衔接块轴线轴向对称。
在一个优选的实施方式中，所述衔接块设有安装槽，至少部分锁定头始终被设置在所述安装槽内， 所述安装槽限制所述锁定头周向转动；这样设计的目的在于：当所述锁定头被设置为异形结构时，操作自锁杆使得锁定头轴向移动至与锁定部配合锁定的过程中，安装槽限制锁定头周向转动，从而使得锁定头按照预定位置进入锁定区域并与锁定部完成配合。
在一个优选的实施方式中，所述衔接块上轴向设置有通孔，所述安装槽设置在所述通孔的远端侧。
在一个实施方式中，所述锁定头被所述安装槽限制朝近端移动，所述安装槽直径大于所述通孔直径。
在一个实施方式中，所述自锁杆是实心的或空心的。
在一个优选的实施方式中，当所述锁定部形成的锁定区域为楔形结构或者所述锁定区域为锥形结构时，所述锁定头对应设置为楔形结构或者锥形结构；当锁定区域和锁定头都为楔形或锥形结构时，锁定的作用力更强，瓣膜夹更加稳固可靠。
在一个实施方式中，所述锁定头为支架形自膨胀结构，所述锁定头与所述锁定部配合实现锁定。
在一个实施方式中，所述锁定头呈锥形结构或梭形结构或菱形结构或棱形结构或箭镞形结构。
在一个优选的实施方式中，所述锁定头中空设置，所述锁定头采用弹性金属材料制成，所述锁定头内部形成有中空区域，为缓冲区域，当瓣膜夹植入到心内后，由于心脏瓣膜自身的挤压和舒张会让夹合臂受到一定的应力，从而影响夹合臂与推送装置之间夹闭程度，出现一定程度的返流，而当锁定头采用用弹性金属材料，且锁定头内部形成有缓冲区域，使得夹合臂的长臂受到瓣膜自身运动带来的应力传递到短臂，随后短臂受到的力传递到锁定头，锁定头发生一定程度的变形，将其受到的应力分解，始终保证夹合臂与推送装置之间的夹闭力度以及紧度，从而避免出现返流。
在一个实施方式中，所述短臂的形态呈弧形或者＂L＂形，所述第一夹合臂和第二夹合臂的张角变大时，所述第一夹合臂上的锁定部与所述第二夹合臂上的锁定部之间错位配合；锁定部设计成弧形段或者＂L＂形有利于增加锁定部的力臂，增强锁定的作用力，同时，锁定部之间错位配合的方式有利于节省装载空间。
在一个实施方式中，所述衔接件设置有与所述自锁杆配合的防退装置；防退装置能增强锁定装置的稳定性，长期保证锁定的效果。
在优选的一个实施方式中，所述防退装置为螺纹或者凹槽。
在一个实施方式中，所述推拉装置包括瓣叶抓捕装置、防漏管件以及与防漏管件铰接并设置在防漏管件左右两侧的第一联动杆和第二联动杆，所述第一联动杆和第二联动杆分别与所述第一夹合臂和第二夹合臂铰接，所述瓣叶抓捕装置设置在所述第一联动杆和第二联动杆上，所述瓣叶抓捕装置具有预设形态，自然状态下，所述瓣叶抓捕装置紧贴所述联动杆，预装时，所述瓣叶抓捕装置始终贴合所述防漏管件，当所述瓣膜夹捕捉到瓣叶时，所述瓣叶抓捕装置恢复预设形态以夹持瓣叶。
在一个优选实施方式中，所述瓣叶抓捕装置可单独控制，分别对单个瓣叶进行夹持锚定，便于降低操作难度。
在一个实施方式中，所述锁定部包括呈梳状分布的多个弧形支杆，所述第一夹合臂和第二夹合臂的张角变大时，所述第一夹合臂上的弧形支杆和所述第二夹合臂上的弧形支杆之间错位配合；多个呈梳状分布的多个弧形支杆有助于增加短臂受力的作用点，使得锁定更加稳固可靠。
在优选的一个实施方式中，所述弧形支杆端部向内弯曲，在所述第一夹合臂和所述第二夹合臂闭合时所述弧形支杆端部向所述锁定装置提供受力点。
在一个实施方式中，所述长臂的横截面为内凹形态；这样设计的目的在于：瓣膜夹在闭合状态时， 长臂对防漏管件起到一定的包裹作用，使其防漏效果更佳，同时，内凹形态的设置也使得长臂的重量大大减轻，有效避免瓣膜夹因重量过大在心内发生滑脱，有利于瓣膜夹锚定在心内的稳固性，不会对原生瓣叶发生过度撕扯、伤害心内组织。
在一个实施方式中，所述长臂与所述推拉装置连接的一端设有圆弧缓冲段；这样设计的好处在于：瓣膜夹在捕捉到瓣叶并完成夹闭时，圆弧缓冲段可以保护原生瓣叶避免受到损伤。
在一个实施方式中，所述夹合臂位于铰接点处设有贴合结构；设计贴合结构的好处在于：短臂以铰接点杠杆带动长臂，因此在锁定时，铰接点处受力比较大，贴合结构可以增加与衔接件的接触面，使得锁定的力矩更加均衡。
与现有技术相比，本发明的优点在于：
1.区别于现有技术，本发明中操作推拉装置使所述第一夹合臂的长臂和第二夹合臂的长臂张角变大呈张开状态时，所述第一夹合臂上的锁定部与所述第二夹合臂上的锁定部部分呈错位配合状态，不会干涉/影响夹合臂之间的张角大小，有利于捕捉以及夹持瓣叶，当瓣膜夹需要锁定时，移动所述锁定装置使得所述锁定头与所述锁定部实现配合并锁定，即完成锁定；利用杠杆原理，使得锁定装置一端与锁定部之间产生力矩平衡，控制第一夹合臂与第二夹合臂的张角不再增大，达到锁闭的效果，同时，锁定结构为机械锁定，结构简单，操作简便又不会有疲劳风险，可长久保证其夹闭效果；
2.区别于现有技术，本发明的短臂的形态呈弧形或者＂L＂形，这样设计的目的在于：弧形段可以增加锁定部的力臂，进而保证瓣膜夹锁定的作用力，使得瓣膜夹的锁定状态更加稳固可靠，同时，错位配合的方式有利于节省装载空间；
3.区别于现有技术，本发明中衔接件设有安装槽，至少部分锁定头始终被设置在安装槽内，安装槽限制锁定头周向转动；这样设计的目的在于：当锁定头被设置为异形结构时，操作自锁杆使得锁定头轴向移动至与锁定部配合锁定的过程中，安装槽限制锁定头周向转动，从而使得锁定头按照预定位置进入锁定区域并与锁定部完成配合，与此同时，衔接件设置安装槽后可以减轻瓣膜夹的重量，有效避免瓣膜夹因重量过大在心内发生滑脱，有利于瓣膜夹锚定在心内的稳固性；
4.区别于现有技术，长臂的横截面为内凹形态；这样设计的目的在于：瓣膜夹在闭合状态时，长臂对防漏管件起到一定的包裹作用，使其防漏效果更佳，同时，内凹形态的设置也使得长臂的重量大大减轻，有效避免瓣膜夹因重量过大在心内发生滑脱，有利于瓣膜夹锚定在心内的稳固性，不会对原生瓣叶发生过度撕扯、伤害心内组织；
5.区别于现有技术，本发明的锁定头为支架形自膨胀结构，锁定头内部形成有中空区域，为缓冲区域，当瓣膜夹植入到心内后，由于心脏瓣膜自身的挤压和舒张会让夹合臂受到一定的应力，从而影响夹合臂与推送装置之间夹闭程度，出现一定程度的返流，而当锁定头采用用弹性金属材料，且锁定头内部形成有缓冲区域，使得夹合臂的长臂受到瓣膜自身运动带来的应力传递到短臂，随后短臂受到的力传递到锁定头，锁定头发生一定程度的变形，将其受到的应力分解，始终保证夹合臂与推送装置之间的夹闭力度以及紧度，从而避免出现返流；
6.区别于现有技术，本发明中设有偏置结构，所述偏置结构使得所述第一夹合臂的长臂和第二夹合臂的长臂张角变小呈闭合状态时，相比于所述传动部，所述贴合部位于更靠近所述瓣膜夹的中轴线的位置，从而使得瓣膜夹在闭合时，长臂能紧贴防漏管件，进一步保证瓣膜夹的闭合力，也提升了防漏效果。
附图说明
图1a～1d为本发明瓣膜夹在实现锁定的过程示意图。
图2a～2h为本发明夹合臂、锁定部、弧形支杆的结构示意图。
图3a～3g为本发明锁定装置和锁定块的结构示意图，其中图3c～3g为锁定块的多种实施方式。
图4a～4d为本发明衔接件的结构示意图。
图5a～5b为本发明输送导管与瓣膜夹拆卸的过程示意图。
图6a～6g为本发明输送导管进入心脏的过程示意图。
图7a～7c为本发明瓣膜夹在左心房打开的过程示意图。
图8a～8h为本发明瓣膜夹运动至最佳捕捉瓣膜位置的过程示意图。
图9a～9c为本发明锁定瓣膜夹锁定装置的另一实施方式。
图10a～10c为本发明锁定瓣膜夹锁定装置的另一实施方式。
图11a～11g为本发明锁定瓣膜夹锁定装置的另一实施方式。
附图中各数字所指代的部位名称如下：1-第一夹合臂，11-短臂，12-长臂，13-贴合结构，111-锁定部，121-圆弧缓冲段，122-偏置结构，123-贴合部，124-传动部，1111-弧形段，1112-弧形支杆，2-第二夹合臂，3-衔接件，31-衔接块，311-通孔，312-安装槽，32-连接耳，33-锁定区域，34-防退装置，4-锁定装置，41-锁定头，42-自锁杆，43-转动结构，431-凹槽，432-凸台，5-防漏管件，51-防漏管连接部，6-第一联动杆，7-第二联动杆，8-输送导管，9-推拉装置，91-瓣叶抓捕装置。
具体实施方式
下面结合附图与实施例对本发明作进一步详细描述。
本发明所述的近端是指接近手术操作者的一端，所述的远端是指远离手术操作者的一端。
具体实施例一：
在用于二尖瓣瓣膜疾病治疗时，如图1a～1d所示，一种带有锁闭机构的瓣膜夹，包括第一夹合臂1、第二夹合臂2、衔接件3、推拉装置9和锁定装置4，所述锁定装置4部分与所述衔接件3配合，所述锁定装置4包括锁定头41和自锁杆42，所述衔接件3分别与所述第一夹合臂1和第二夹合臂2铰接，所述夹合臂包括长臂12和短臂11，所述长臂12的一端与所述推拉装置9铰链连接，所述短臂11的一端设置有锁定部111，操作推拉装置9使所述第一夹合臂1的长臂12和第二夹合臂2的长臂12张角变大呈张开状态时，所述第一夹合臂1上的锁定部111与所述第二夹合臂2上的锁定部111部分呈错位配合状态；操作推拉装置9使所述第一夹合臂1的长臂12和第二夹合臂2的长臂12张角变小呈闭合状态时，移动所述锁定装置4使得所述锁定头41与所述锁定部111实现配合并锁定。
下面将结合附图详细描述本发明的带有锁闭机构的瓣膜夹各部件的组成和连接方式；
本实施例中，所述锁定部111与所述衔接件3之间形成有锁定区域33，所述锁定区域33的大小随所述夹合臂的张角变化而变化，当所述第一夹合臂1和第二夹合臂2的张角变小时，所述锁定区域33逐步变大，所述锁定头41进入所述锁定区域33并与所述锁定部111完成锁定配合时，所述瓣膜夹即被锁定，如图2e和2f所示。
本实施例中，所述长臂12上设有偏置结构122，如图2h所示，所述偏置结构122所述偏置结构122将所述长臂12分为贴合部123和传动部124，当所述第一夹合臂1的长臂12和第二夹合臂2的长臂12张角变小呈闭合状态时，相比于所述传动部124，所述贴合部123位于更靠近所述瓣膜夹的中轴线的位置；这样设计的好处在于，当瓣膜夹处于闭合状态时，所述长臂能12紧贴所述推拉装置9，进一步增加夹合效果，同时提升了防漏功能。
本实施例中，所述锁定部111包括弧形段1111，如图2a和2b所示，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的弧形段1111与所述第二夹合臂2上的弧形段2111之间错位扣接；锁定部111设计成弧形段1111有利于增加锁定部111的力臂，增强锁定的作用力，同时，错位扣接的方式有利于节省装载空间；同理，所述锁定部111也可设置成＂L＂形，如图2g所示。
本实施例中，所述锁定部111包括多个弧形支杆1112，如图2c所示，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的弧形支杆1112和所述第二夹合臂2上的弧形支杆1112之间错位扣接；多个弧形支杆1112有助于增加短臂11受力的作用点，使得锁定更加稳固可靠。
本实施例中，所述第一夹合臂1有三个弧形支杆1112，所述第二夹合臂2有两个弧形支杆2112，如图2b和2d所示，在保证弧形支杆1112强度的前提下，所述弧形支杆1112端部触及所述锁定头41。
本实施例中，所述夹合臂位于铰接点处设有贴合结构13，如图2c所示；设计贴合结构13的好处在于：短臂11以铰接点杠杆带动长臂12，因此在锁定时，铰接点处受力比较大，贴合结构13可以增加与衔接件3的接触面，使得锁定的力矩更加均衡。
本实施例中，所述锁定装置4包括锁定头41和自锁杆42，如图3a和3b所示；所述锁定头41与所述短臂11上的锁定部111为梯形配合或楔形配合或锥形配合或圆面配合或正方体配配合，如图3c～3g所示。
本实施例中，所述衔接件3包括衔接块31以及设置在衔接块31上的连接耳32，如图4a和4b所示，所述衔接块31与所述锁定装置4连接，所述连接耳32分别与所述第一夹合臂1和第二夹合臂2铰接。
本实施例中，所述衔接件3可以为弧形结构或＂V＂形结构，如图4c和4d所示；这样设计的目的在于：预装时可以缩短瓣膜夹的装载长度。
本实施例中，所述衔接件3设置有与所述自锁杆42配合的防退装置34；防退装置34能增强锁定装置4的稳定性，长期保证锁定的效果。
本实施例中，所述防退装置34为螺纹或者凹槽。
本实施例中，所述推拉装置9包括瓣叶抓捕装置91、防漏管件5以及与防漏管件5铰接并设置在防漏管件5左右两侧的第一联动杆6和第二联动杆7，所述第一联动杆6和第二联动杆7分别与所述第一夹合臂1和第二夹合臂2铰接，所述瓣叶抓捕装置91设置在所述第一联动杆6和第二联动杆7上，所述瓣叶抓捕装置91具有预设形态，自然状态下，所述瓣叶抓捕装置91紧贴所述联动杆，预装时，所述瓣叶抓捕装置91始终贴合所述防漏管件5，当所述瓣膜夹捕捉到瓣叶时，所述瓣叶抓捕装置91恢复预设形态以夹持瓣叶。
本实施例中，所述长臂12与所述推拉装置9连接的一端设有圆弧缓冲段121，如图2a和2b所示，瓣膜夹在捕捉到瓣叶并完成夹闭时，所述圆弧缓冲段121可以保护原生瓣叶避免受到损伤。
本实施例中，长臂12的横截面为内凹形态；这样设计的目的在于：瓣膜夹在闭合状态时，长臂12对防漏管件5起到一定的包裹作用，使其防漏效果更佳，同时，内凹形态的设置也使得长臂12的重量大大减轻，有效避免瓣膜夹因重量过大在心内发生滑脱，有利于瓣膜夹锚定在心内的稳固性，不会对原生瓣叶发生过度撕扯、伤害心内组织。
本实施例中，所述瓣膜夹还包括瓣膜夹输送系统，所述瓣膜夹输送系统包括控制手柄，与控制手 柄连接的输送导管8，如图5a～5b所示，所述输送导管8的远端部分与所述瓣膜夹可拆卸连接，预装时，所述输送导管8与所述瓣膜夹连接，当所述瓣膜夹被植入到目标位置后，所述输送导管8与所述瓣膜夹可分离。
本发明的工作原理为：
1.操作所述瓣膜夹输送导管8从下腔静脉进入心脏，随后操作输送导管8使得所述瓣膜夹穿过房间隔，如图6a～6e所示；继续操作所述输送导管8弯曲使得所述瓣膜夹正对二尖瓣，如图6f和6g所示；
2.操作控制手柄后撤外鞘使得瓣膜夹暴露在左心房内，操作控制手柄使得锁定装置4相对防漏管件5朝远端移动，直至第一夹合臂1和第二夹合臂2张角最大处，如图7a～7c所示；
3.操作控制手柄使瓣膜夹穿过二尖瓣，如图8a所示，通过影像判断所述瓣膜夹是否位于最佳瓣膜夹合位置，若为最佳位置，则直接按步骤5进行；若非最佳位置，按步骤4进行。
4.操作控制手柄使得锁定装置4拉至最远端，此时瓣膜夹所占径向空间最小，将瓣膜夹拉动至左心房，如图8b～8d所示，所述夹合臂与所述联动杆呈钝角符合生理结构，不会伤害心内腱索等组织；操作控制手柄旋转、输送瓣膜夹至最佳瓣膜夹合位置，如图8e～8h所示；
5.操作控制手柄进行瓣叶夹合使得前瓣部分和后瓣部分进入瓣叶抓捕装置91中，分别被固定在所述防漏管件5和第一联动杆6之间与所述防漏管件5和第二联动杆7之间；
6.操作控制手柄使得所述锁定装置4朝近端移动，直至第一夹合臂1和所述第二夹合臂2张角最小处，如图1c所示；
7.操作所述锁定装置4沿着所述衔接件3轴向朝远端移动直至所述锁定头41与所述第一锁定部111和第二锁定部111相抵触，实现瓣膜夹锁定目的，如图1d所示；
8.操作所述控制手柄使得所述输送导管8与所述瓣膜夹分离，如图5a和5b所示，输送导管8撤离体内。
具体实施例二：
在另一个实施方式中，如图9a和9b所示，一种带有锁闭机构的瓣膜夹，包括第一夹合臂1、第二夹合臂2、衔接件3和锁定装置4，所述锁定装置4与所述衔接件3连接，所述衔接件3分别与所述第一夹合臂1和第二夹合臂2铰接，所述夹合臂包括长臂12和短臂11，所述短臂11以铰接点杠杆带动所述长臂12，所述短臂11的一端设置有锁定部111，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的锁定部111与所述第二夹合臂2上的锁定部111之间错位扣接，所述第一夹合臂1和第二夹合臂2的张角变小时，所述锁定部111和所述衔接件3之间形成锁定区域33，所述锁定装置4一端进入所述锁定区域33并与所述锁定部111完成锁定配合；
所述瓣膜夹还包括推拉装置9，所述推拉装置9包括瓣叶抓捕装置91、防漏管件5以及与防漏管件5铰接并设置在防漏管件5左右两侧的第一联动杆6和第二联动杆7，所述第一联动杆6和第二联动杆7分别与所述第一夹合臂1和第二夹合臂2铰接，所述瓣叶抓捕装置91设置在所述第一联动杆6和第二联动杆7上，所述瓣叶抓捕装置91具有预设形态，自然状态下，所述瓣叶抓捕装置91紧贴所述联动杆，预装时，所述瓣叶抓捕装置91始终贴合所述防漏管件5，当所述瓣膜夹捕捉到瓣叶时，所述瓣叶抓捕装置91恢复预设形态以夹持瓣叶。
本实施例中，所述锁定装置4与所述衔接件3为螺纹连接，所述锁定装置4在心内不受外力的情况下无法旋转，故锁定装置4抵住所述第一锁定部111和第二锁定部211后无法进行轴向移动，所述 第一锁定部111和第二锁定部211分别得到来自所述锁定装置4的径向的相反的支撑，如图9c所示，所述第一夹合臂1得到朝左的径向支撑力，所述第二夹合臂2得到朝右的径向支撑力，使得所述第一夹合臂1和所述第二夹合臂2无法张开，下面将结合附图详细描述本发明的带有锁闭机构的瓣膜输送系统各部件的组成和连接方式；
本实施例中，所述锁定部111包括弧形段1111，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的弧形段1111与所述第二夹合臂2上的弧形段2111之间错位扣接；锁定部111设计成弧形段1111有利于增加锁定部111的力臂，增强锁定的作用力，同时，错位扣接的方式有利于节省装载空间。
本实施例中，所述第一弧形支杆1112和第二弧形支杆2112长度较上一实施例有所变化，在所述第一夹合臂1和所述第二夹合臂2闭合时所述第一弧形支杆1112与第二弧形支杆2112之间形成有孔洞，所述锁定装置4上的锁定头41呈锥形结构设置，所述锁定装置4上的锁定头41近端部分的直径大于所述第一弧形支杆1112端部与第二弧形支杆2112端部之间的距离，操作所述锁定装置4使其锁定头41的远端部分进入/穿过所述第一弧形支杆1112和第二弧形支杆1112之间的孔洞，同时，所述锁定头41部分还与所述第一弧形支杆1112和第二弧形支杆1112相抵触进行限位以起到锁定目的，如图9b和9c所示。
具体实施例三：
在另一个实施方式中，如图10a和10b所示，一种带有锁闭机构的瓣膜夹，包括第一夹合臂1、第二夹合臂2、衔接件3和锁定装置4，所述锁定装置4与所述衔接件3连接，所述锁定装置4包括锁定头41和自锁杆42，所述衔接件3分别与所述第一夹合臂1和第二夹合臂2铰接，所述夹合臂包括长臂12和短臂11，所述短臂11以铰接点杠杆带动所述长臂12，所述短臂11的一端设置有锁定部111，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的锁定部111与所述第二夹合臂2上的锁定部111之间错位扣接，所述第一夹合臂1和第二夹合臂2的张角变小时，所述锁定部111和所述衔接件3之间形成锁定区域33，所述锁定装置4一端进入所述锁定区域33并与所述锁定部111完成锁定配合；
所述瓣膜夹还包括推拉装置9，所述推拉装置9包括瓣叶抓捕装置91、防漏管件5以及与防漏管件5铰接并设置在防漏管件5左右两侧的第一联动杆6和第二联动杆7，所述第一联动杆6和第二联动杆7分别与所述第一夹合臂1和第二夹合臂2铰接，所述瓣叶抓捕装置91设置在所述第一联动杆6和第二联动杆7上，所述瓣叶抓捕装置91具有预设形态，自然状态下，所述瓣叶抓捕装置91紧贴所述联动杆，预装时，所述瓣叶抓捕装置91始终贴合所述防漏管件5，当所述瓣膜夹捕捉到瓣叶时，所述瓣叶抓捕装置91恢复预设形态以夹持瓣叶。
本实施例中，所述自锁杆42与所述衔接件3为螺纹连接，所述锁定装置4在心内不受外力的情况下无法旋转，故锁定头41抵住所述第一锁定部111和第二锁定部211后无法进行轴向移动，所述第一锁定部111和第二锁定部211分别得到来自所述锁定头41的径向的相反的支撑，如图10c所示，所述第一夹合臂1得到朝左的径向支撑力，所述第二夹合臂2得到朝右的径向支撑力，使得所述第一夹合臂1和所述第二夹合臂2无法张开，下面将结合附图详细描述本发明的带有锁闭机构的瓣膜输送系统各部件的组成和连接方式；
与上述实施例不同的是中，本实施例中所述锁定头41为支架形自膨胀结构，所述锁定头41与所述锁定部111配合实现锁定。
本实施例中，所述锁定头41可以呈锥形结构或梭形结构或菱形结构或棱形结构或箭镞形结构，所述锁定头41的远端部分为锥形结构。
本实施例中，所述锁定头41呈菱形结构设置，所述锁定头41中空设置，所述锁定头41采用弹性金属材料制成，所述锁定头41内部形成有中空区域，为缓冲区域，当瓣膜夹植入到心内后，由于心脏瓣膜自身的挤压和舒张会让夹合臂受到一定的应力，从而影响夹合臂与推送装置之间夹闭程度，出现一定程度的返流，而当锁定头41采用用弹性金属材料，且锁定头41内部形成有缓冲区域，使得夹合臂的长臂12受到瓣膜自身运动带来的应力传递到短臂11，随后短臂11受到的力传递到锁定头41，锁定头41发生一定程度的变形，将其受到的应力分解，始终保证夹合臂与推拉装置9之间的夹闭力度以及紧度，从而避免出现返流。
本实施例中，所述锁定部111包括多个弧形支杆1112，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的弧形支杆1112和所述第二夹合臂2上的弧形支杆2112之间错位扣接；多个弧形支杆1112有助于增加短臂11受力的作用点，使得锁定更加稳固可靠。
具体实施例四：
在另一个实施方式中，如图11a～11c所示，一种带有锁闭机构的瓣膜夹，包括第一夹合臂1、第二夹合臂2、衔接件3和锁定装置4，所述锁定装置4与所述衔接件3连接，所述锁定装置4包括锁定头41和自锁杆42，所述衔接件3分别与所述第一夹合臂1和第二夹合臂2铰接，所述夹合臂包括长臂12和短臂11，所述短臂11以铰接点杠杆带动所述长臂12，所述短臂11的一端设置有锁定部111，所述第一夹合臂1和第二夹合臂2的张角变大时，所述第一夹合臂1上的锁定部111与所述第二夹合臂2上的锁定部111之间错位扣接，所述第一夹合臂1和第二夹合臂2的张角变小时，所述锁定部111和所述衔接件3之间形成锁定区域33，所述锁定装置4一端进入所述锁定区域33并与所述锁定部111完成锁定配合；
所述瓣膜夹还包括推拉装置9，所述推拉装置9包括瓣叶抓捕装置91、防漏管件5以及与防漏管件5铰接并设置在防漏管件5左右两侧的第一联动杆6和第二联动杆7，所述第一联动杆6和第二联动杆7分别与所述第一夹合臂1和第二夹合臂2铰接，所述瓣叶抓捕装置91设置在所述第一联动杆6和第二联动杆7上，所述瓣叶抓捕装置91具有预设形态，自然状态下，所述瓣叶抓捕装置91紧贴所述联动杆，预装时，所述瓣叶抓捕装置91始终贴合所述防漏管件5，当所述瓣膜夹捕捉到瓣叶时，所述瓣叶抓捕装置91恢复预设形态以夹持瓣叶。
本实施例中，所述自锁杆42与所述锁定头41之间设置有转动结构43，使得所述自锁杆42与所述锁定头41之间能够相对转动，如图11d所示。
本实施例中，所述转动结构43包括凹槽431和凸台432，所述凹槽431设置在所述锁定头41的近端，所述凸台432设置在所述自锁杆42的远端，所述凹槽431与所述凸台432相配合，如图11d所示。
本实施例中，所述衔接件3设有安装槽312，至少部分锁定头41始终被设置在所述安装槽312内，所述安装槽312限制所述锁定头周向转动。
本实施例中，所述安装槽312形状与所述锁定头41形状配合，所述锁定头41呈锥形结构或或楔形结构或梭形结构或箭镞形结构，如图11e～11g所示。
本实施例中，所述衔接件3包括衔接块31以及设置在衔接块31上的连接耳32，所述衔接块31与所述锁定装置4连接，所述连接耳32分别与所述第一夹合臂1和第二夹合臂2铰接，所述衔接块 31上轴向设置有通孔311和安装槽312，所述安装槽312设置在所述通孔311的远端侧；衔接件3设置安装槽312后可以减轻瓣膜夹的重量，有效避免瓣膜夹因重量过大在心内发生滑脱，有利于瓣膜夹锚定在心内的稳固性。
本实施例中，所述连接耳32关于衔接块31的中心轴线对称。
本实施例中，所述衔接块31设有安装槽312，至少部分锁定头41始终被设置在所述安装槽312内，所述安装槽312限制所述锁定头41周向转动，在预装时，所述锁定头41全部位于所述安装槽312内，可以节省装载空间，当所述锁定头41与锁定部111完成配合锁定，所述锁定头41仍有部分在所述安装槽312内；这样设计的目的在于：当所述锁定头41被设置为异形结构时，操作自锁杆42使得锁定头41轴向移动至与锁定部111配合锁定的过程中，安装槽312限制锁定头41周向转动，从而使得锁定头41按照预定位置进入锁定区域33并与锁定部完成配合。
本实施例中，所述安装槽312设置在所述通孔311的远端侧。
本实施例中，所述锁定头41被所述安装槽312限制朝近端移动，所述安装槽312直径大于所述通孔311直径。
以上内容仅为本发明的较佳实施例，对于本领域的普通技术人员，依据本发明的思想，在具体实施方式及应用范围上均会有改变之处，本说明书内容不应理解为对本发明的限制。

Claims (10)

  1. 一种带有锁闭机构的瓣膜夹，包括第一夹合臂、第二夹合臂、衔接件、推拉装置和锁定装置，其中，所述锁定装置部分与所述衔接件配合，所述锁定装置包括锁定头和自锁杆，所述衔接件分别与所述第一夹合臂和第二夹合臂铰接，所述夹合臂包括长臂和短臂，所述长臂的一端与所述推拉装置铰链连接，所述短臂的一端设置有锁定部，操作推拉装置使所述第一夹合臂的长臂和第二夹合臂的长臂张角变大呈张开状态时，所述第一夹合臂上的锁定部与所述第二夹合臂上的锁定部部分呈错位配合状态；操作推拉装置使所述第一夹合臂的长臂和第二夹合臂的长臂张角变小呈闭合状态时，移动所述锁定装置使得所述锁定头与所述锁定部实现配合并锁定。
  2. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述短臂的形态呈弧形或者＂L＂形，所述第一夹合臂和第二夹合臂的张角变大时，所述第一夹合臂上的锁定部与所述第二夹合臂上的锁定部之间错位配合。
  3. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述锁定头为支架形自膨胀结构，所述锁定头与所述锁定部配合实现锁定。
  4. 根据权利要求3所述的一种带有锁闭机构的瓣膜夹，其中，所述锁定头呈锥形结构或梭形结构或菱形结构或棱形结构或箭镞形结构。
  5. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述自锁杆与所述锁定头之间设置有转动结构，使得所述自锁杆与所述锁定头之间能够相对转动。
  6. 根据权利要求5所述的一种带有锁闭机构的瓣膜夹，其中，所述衔接件设有安装槽，至少部分锁定头始终被设置在所述安装槽内，所述安装槽限制所述锁定头周向转动。
  7. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述长臂上设有偏置结构，所述偏置结构将所述长臂分为贴合部和传动部，当所述第一夹合臂的长臂和第二夹合臂的长臂张角变小呈闭合状态时，相比于所述传动部，所述贴合部位于更靠近所述瓣膜夹的中轴线的位置。
  8. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述衔接件为弧形结构或＂V＂形结构。
  9. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述长臂的横截面为内凹形态。
  10. 根据权利要求1所述的一种带有锁闭机构的瓣膜夹，其中，所述长臂与所述推拉装置连接的一端设有圆弧缓冲段。
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