WO2022241755A1 - 二尖瓣瓣环的环缩装置 - Google Patents

二尖瓣瓣环的环缩装置 Download PDF

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Publication number
WO2022241755A1
WO2022241755A1 PCT/CN2021/095110 CN2021095110W WO2022241755A1 WO 2022241755 A1 WO2022241755 A1 WO 2022241755A1 CN 2021095110 W CN2021095110 W CN 2021095110W WO 2022241755 A1 WO2022241755 A1 WO 2022241755A1
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WO
WIPO (PCT)
Prior art keywords
locking
annulus
fixing
knot
distal end
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PCT/CN2021/095110
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English (en)
French (fr)
Inventor
赵洋
刘小建
张昱昕
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上海形状记忆合金材料有限公司
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Publication date
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Priority to EP21940208.8A priority Critical patent/EP4335411A1/en
Priority to PCT/CN2021/095110 priority patent/WO2022241755A1/zh
Publication of WO2022241755A1 publication Critical patent/WO2022241755A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • 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
    • A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
    • A61F2/2457—Chordae tendineae prostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0406—Pledgets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0487—Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks
    • A61B2017/0488—Instruments for applying suture clamps, clips or locks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B2017/0496—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials for tensioning sutures

Definitions

  • the present application belongs to the technical field of medical devices, and in particular relates to a mitral valve ring constriction device.
  • the human heart has four chambers and four valves, the mitral valve, tricuspid valve, aortic valve and pulmonary valve.
  • the mitral valve is located between the left atrium and the left ventricle, like a one-way valve, which ensures that the blood circulation flows from the left atrium to the left ventricle and passes through a certain amount of flow.
  • the mitral valve consists of five parts: leaflets, annulus, papillary muscles, chordae and junction. When the normal mitral valve is closed, the two valve leaflets are in the same plane and close together, which can completely block the backflow of left ventricular blood flow.
  • the functional integrity of the mitral valve requires that the size of the mitral valve ring is appropriate, the leaflet structure is intact, the papillary muscle contracts and pulls the chordae to play the role of making the valve leaflet, the left ventricular muscle contracts and closes properly, and the shape and function of the ventricle are normal. Abnormalities in any of these factors can lead to mitral regurgitation, the backflow of blood from the left ventricle into the left atrium.
  • the actual technical problem to be solved in this application is to provide a ring constriction device for repairing mitral valve annular insufficiency.
  • constriction device of mitral valve annulus that the application provides, comprises
  • any one of the fixing mechanisms includes a fixing knot and a pulling wire, the pulling wire is installed on the fixing knot, and both ends of the pulling wire are located near the fixing knot end outside;
  • the puncture mechanism is used to puncture the fixed knot and pulling wire of any one of the fixing mechanisms on the valve annulus, and make the fixed knot on one side of the valve annulus, and the two ends of the pulling wire are positioned on the valve annulus.
  • the other side of the ring; the pulling wires of the two adjacent fixing mechanisms are driven by the traction force and approach each other to shorten the distance between the two adjacent fixing knots;
  • the locking mechanism is used for locking the ends of the pulling wires of the two adjacent fixing mechanisms on the annulus when the pulling wires of the two adjacent fixing mechanisms are pulled in place.
  • the locking mechanism includes
  • a locking body having a first channel extending along its length
  • the locking plug is inserted into the first channel to clamp the pulling wire between the locking plug and the locking main body.
  • a locking hole is provided on the side wall of the locking body through which the end of the pulling wire passes.
  • a first installation hole is further provided on the side wall of the locking body
  • It also includes at least one elastic body, the proximal end of which is formed in the first installation hole, and the distal end of which tends to protrude into the first channel under the action of its own deformation;
  • the elastic body When the locking plug is plugged toward the first channel, the elastic body is pressed by the outer wall of the locking plug and swings toward the first mounting hole; when the locking plug passes over the elastic body After the distal end of the elastic body resets and its distal end is blocked on the locking plug.
  • the locking plug includes a base and a first annular boss formed on the outer periphery of the distal end of the base, and the first annular boss applying the extruding force to the elastic body;
  • the inner wall of the distal end of the locking body is provided with a second annular boss protruding inward;
  • the distal end of the first annular boss is held between the second annular boss and the elastic body by being blocked by the second annular boss; and/or
  • the elastic body is a shrapnel.
  • the locking mechanism further includes a delivery mechanism;
  • the delivery mechanism includes an outer tube, a hanging sheath slidably arranged in the outer tube, and a slidable The pushing inner tube that is arranged in the hanging head sheath tube;
  • the distal end of the hanger sheath is detachably connected to the proximal end of the locking main body, and the distal end of the pushing inner tube is inserted or sleeved on the proximal end of the locking plug; on the locking main body Before being released, both the locking body and the locking plug are located in the outer tube.
  • the puncture mechanism includes
  • the puncture needle is slidably arranged in the outer sheath, and the outer wall of the distal end of the puncture needle is provided with a gap channel extending along the length direction of the puncture needle;
  • Pushing sheath slidably arranged in the outer sheath tube, covered outside the puncture needle;
  • the fixed knot has a folded state folded in the outer sheath and a released state pierced on the valve annulus;
  • the fixing knot is looped on the outer wall of the gap channel of the puncture needle, the proximal end of the puncture needle is distributed opposite to the distal end of the push sheath; the first end of the pulling wire is located at the In the gap channel, its second end passes through the gap channel, wraps around the outer wall of the fixed knot from the far end of the fixed knot, and extends into the puncture needle through the proximal end of the gap channel , so that the first end and the second end overlap;
  • the pulling wire is wrapped on the side wall of the fixing knot, the pulling wire is pierced on the valve annulus, and the fixing knot is bent into a ring shape by being pulled by the pulling wire.
  • the side wall of the gap channel of the puncture needle is provided with an inwardly recessed notch; At the notch, the second end of the pulling wire is wound around the outer wall of the fixing knot after passing through the notch.
  • the fixation knot is in the shape of a spiral or a tube
  • a fixed head is provided on the distal end surface of the outer sheath, and the fixed head is trumpet-shaped from the proximal end to the distal end.
  • the application provides a ring constriction device for the mitral valve annulus, including at least two fixing mechanisms, a puncture mechanism and a locking mechanism; wherein, any of the fixing mechanisms includes a fixing knot and a pulling wire, and the pulling wire is installed on the fixed knot, and both ends of the pulling wire are located outside the proximal end of the fixed knot; the puncture mechanism is used to puncture the fixed knot and pulling wire of any fixing mechanism on the valve annulus, and make the fixed knot be located on the valve annulus The two ends of the pulling wire are located on the other side of the valve annulus; the pulling wires of the two adjacent fixing mechanisms are driven by traction and approach each other to shorten the length of the two adjacent fixing mechanisms.
  • the locking mechanism includes a locking main body and a locking plug, the locking main body has a first channel extending in its length direction; the locking plug is inserted into the first channel to pull the The pulling wire is clamped between the locking plug and the locking main body, so as to lock the pulling wires of two adjacent fixing mechanisms, so as to maintain the distance between the two fixing knots.
  • the side wall of the locking body is provided with a locking hole through which the end of the pulling wire passes, so as to ensure that when the locking plug slides in the first channel, The pulling wire is always kept threaded in the locking hole, and will not slide out of the first passage along the length direction of the first passage, thereby further ensuring the locking effect on the pulling wire.
  • a first mounting hole is also provided on the side wall of the locking body; it also includes at least one elastic body, the proximal end of which is molded in the first mounting hole , its distal end tends to protrude into the first passage under the action of its own deformation; when the locking plug is plugged toward the first passage, the elastic body is pressed by the outer wall of the locking plug toward the first Swing in the installation hole; after the locking plug passes over the distal end of the elastic body, the elastic body resets and its distal end blocks on the locking plug, further ensuring that after the locking plug is inserted in place, even with the mitral valve The ring cannot disengage from the proximal end of the locking body during movement.
  • FIG. 1 is a sectional view of the puncture mechanism of the mitral annulus constriction device in Example 1 of the present application;
  • Fig. 2 is a sectional view of another embodiment of the puncture mechanism in Example 1 of the present application.
  • Fig. 3 is a structural schematic diagram of the puncture needle of the puncture mechanism in Fig. 1;
  • Fig. 4a is a schematic diagram of the state in which the fixed head end of the puncture mechanism in Fig. 1 is fixed on the annulus;
  • Fig. 4b is a schematic diagram of the state of the puncture needle, the pushing sheath and the fixing knot of the puncture mechanism in Fig. 1 after they are punctured in the annulus;
  • Figure 4c is a schematic diagram of a state in which the push sheath is not withdrawn after the puncture needle of the puncture mechanism in Figure 1 is withdrawn;
  • Fig. 4d is a schematic diagram of the state after the fixed knot of the puncture mechanism in Fig. 1 is bent;
  • Fig. 4e is a schematic diagram of the state of the entire puncture mechanism in Fig. 1 after retraction;
  • Fig. 5 is a sectional view of the locking mechanism in Embodiment 1 of the present application.
  • Fig. 6 is a schematic structural view of the locking body in Fig. 5;
  • Fig. 7 is a schematic structural view of the locking body in Fig. 5;
  • Fig. 8a is a schematic cross-sectional view of the locking body in Fig. 5;
  • Fig. 8b is a schematic cross-sectional view of the locking body in Fig. 8a after being matched with the pulling wire;
  • Fig. 9 is a schematic structural view of the locking plug in Fig. 5;
  • Fig. 10 is a schematic diagram of the transapical implantation of the constriction device of the mitral valve annulus
  • Fig. 11a is a schematic diagram of the mitral annulus constriction device punctured on the annulus and unlocked;
  • Figure 11b is a schematic diagram of the state in which the constriction device of the mitral valve annulus is punctured on the annulus and locked
  • Fig. 12 is a schematic diagram of the position of the mitral annulus constriction device on the atrial surface annulus
  • Fig. 13 is a schematic diagram of the constriction state of the mitral valve annulus after the constriction device is locked
  • connection should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection. Connected, or integrally connected; it can be directly connected, or indirectly connected through an intermediary, and it can be the internal communication of two elements. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application in specific situations.
  • This embodiment provides a mitral annulus constriction device, as shown in FIGS. 1 to 13 , which includes at least two fixing mechanisms, a puncture mechanism 1 and a locking mechanism 2 .
  • any fixing mechanism comprises fixed knot 14 and pulling wire 15, and pulling wire 15 is installed on the fixing knot 14, and the two ends of pulling wire 15 are all positioned outside the proximal end of fixing knot 14;
  • Piercing mechanism 1 is used for Puncture the fixed knot 14 and pulling wire 15 of any fixing mechanism on the annulus, and make the fixing knot 14 be located on one side of the valve annulus (for example, on the side of the left atrium), and the two ends of the pulling wire 15 are positioned on the valve annulus.
  • the locking mechanism 2 includes a locking body 21 and a locking plug 22 .
  • the locking main body 21 has a first passage extending along its length direction; the locking plug 22 is inserted into the first passage, and the pulling wire 15 is clamped between the locking plug 22 and the locking main body 21, and the pulling wire 15 is pulled at this time. Both ends of the wire 15 need to protrude from the proximal end of the locking body 21 to lock the pulling wire 15 on the locking body 21 so that the adjusted distance between the two fixing knots 14 can be maintained.
  • the side wall of the locking body 21 is provided with a locking hole 27 through which the end of the pulling wire 15 passes.
  • the two ends of the pulling wire 15 pass through the first channel and then pass through the locking hole 27, and then the distance between the two fixing knots 14 is adjusted by applying traction to the pulling wire 15. , when it is adjusted in place, then insert the locking plug 22 into the locking body 21.
  • the setting of the locking hole 27 does not require the two ends of the pulling wire 15 to extend out of the proximal end of the first passage, only need to extend the locking Outside the hole 27, it is also convenient to apply traction to the pulling wire 15.
  • a first installation hole 213 is also provided on the side wall of the locking body 21;
  • the locking mechanism 2 also includes at least one elastic body 26, and the proximal end of the elastic body 26 is molded on the first In the installation hole 213, its far end tends to stretch into the first channel under the effect of its own deformation; Swing towards the first installation hole 213; after the locking plug 22 passes over the distal end of the elastic body 26, the elastic body 26 resets and its distal end blocks on the locking plug 22, so that the proximal end of the locking plug 22 is limited to the locking body 21, to avoid sliding out from the proximal end of the locking body 21.
  • the locking plug 22 includes a base 222 and a first annular boss 221 formed on the outer periphery of the distal end of the base 222, and the first annular boss 221 exerts a pressing force on the elastic body 26. ; When the elastic body 26 is reset, the distal end of the elastic body 26 is blocked on the proximal side of the first annular boss 221 to realize the blocking force on the locking plug 22 .
  • only the distal end of the base 222 and the first annular boss 221 may be provided, and the end surface of the first annular boss 221 serves as the proximal end surface of the locking plug 22 .
  • the locking body 21 and the elastic body 26 are integrally formed, preferably, nickel-titanium alloy material, or other medical deformable alloy material, or memory alloy material.
  • the elastic body 26 is a shrapnel or a spring.
  • rubber material is used to form a rubber plug, or other medical polymer materials.
  • the inner wall of the distal end of the locking body 21 is provided with a second annular boss 211 protruding inward; the distal end of the first annular boss 221 is supported by the second The annular boss 211 is blocked and kept between the second annular boss 211 and the elastic body 26 . That is, when the locking plug 22 slides into place on the locking body 21, under the cooperation of the second annular boss 211 and the elastic body 26, the locking plug 22 is restricted on the locking body 21, and the locking plug 22 cannot move relative to the locking body 21. , to further ensure the locking effect on the pulling wire 15.
  • first channel and the first installation hole 213 it is best to use a circular hole, and of course it can also be a hole of other shapes, such as a rectangular hole or an oval hole, or any other shape.
  • the above-mentioned locking mechanism 2 also includes a delivery mechanism for delivering the locking body 21 and the locking plug 22; the delivery mechanism includes an outer tube 24, a hanging sheath slidably arranged in the outer tube 24 23.
  • the pushing inner tube 25 slidably arranged in the hanging head sheath 23; wherein, the distal end of the hanging head sheath 23 is detachably connected with the proximal end of the locking main body 21, and the distal end of the pushing inner tube 25 is plugged In the inner hole of the proximal end of the locking plug 22 , or sleeved outside the proximal end of the locking plug 22 ; before the locking body 21 is released, the locking body 21 and the locking plug 22 are both located in the outer tube 24 .
  • the entire delivery mechanism is delivered to the vicinity of the mitral valve annulus through the apex of the heart, the outer tube 24 stops moving, and the hanging sheath 23 pushes the locking main body 21, so that the locking main body 21 protrudes from the distal end of the outer tube 24 Outside, the hanger sheath tube 23 is separated from the locking main body 21; the end of the pulling wire 15 is passed in the locking hole 27, and the tension between the two fixing knots 14 is adjusted by applying a pulling force to the end of the pulling wire 15.
  • Distance after the distance between the two fixed knots 14 is adjusted in place, push the inner tube 25 and push the locking plug into the locking body 21.
  • the entire delivery mechanism is withdrawn from the human body.
  • the proximal end of the locking body 21 is provided with two notch grooves 212 symmetrically distributed, and correspondingly, the distal end of the hanger sheath 23 is provided with a The hanging ear (not shown in the figure) in the gap; before it is released, the hanging ear is subjected to the radial constraint force of the outer tube 24, so that the hanging ear remains clamped in the gap groove 212; when the hanging head sheath tube 23 stretches out In the tube 24 , the lug resets under the action of its own deformation, tends to swing outward, and withdraws from the notch groove 212 to realize the separation of the hanging sheath 23 and the locking body 21 .
  • the puncture mechanism 1 includes an outer sheath tube 13 , a puncture needle 12 and a push sheath 16 .
  • the puncture needle 12 is slidably arranged in the outer sheath tube 13, and the outer wall of the distal end of the puncture needle 12 is provided with a gap channel 121 extending along the length direction of the puncture needle 12; the push sheath 16 is slidably arranged in the outer sheath tube 13, Cover the puncture needle.
  • the fixed knot 14 has a folded state folded in the outer sheath tube 13 and a released state punctured on the annulus; in the folded state, as shown in Figures 1 and 2, the fixed knot 14 is sleeved on the outer wall of the gap channel 121 of the puncture needle , the proximal end of the puncture needle is relatively distributed with the distal end of the push sheath 16; the first end of the pulling wire 15 is located in the notch channel 121, and its second end passes through the notch channel 121, and is wound around the far end of the fixed knot 14 On the outer wall of the fixed knot 14, and extend into the puncture needle through the proximal end of the notch channel 121, so that the first end and the second end overlap and distribute, and the overlappingly distributed ends of the pulling wire 15 can extend out of the puncture needle. Outside the proximal end, it is convenient for the operator to apply pulling force to the pulling wire 15; or it is distributed in the puncture needle and connected to the operating mechanism to apply pulling force to the pulling wire
  • the distal end surface of the outer sheath tube 13 first abuts against the annulus, and then the puncture needle and the pushing sheath 16 slide towards the distal end synchronously, and the pushing sheath 16 is used to push and fix Knot 14, when ensuring that the puncture needle and the pushing sheath 16 are punctured on the mitral valve annulus as a whole, the fixed knot 14 is located at the side of the mitral valve close to the atrium, as shown in Figure 4b; due to the existence of the gap channel 121, the puncture needle and the fixed To disengage the knot 14, first withdraw the puncture needle, as shown in Figure 4c; then apply a pulling force to the pulling wire 15, so that the fixed knot 14 is bent into a ring, as shown in Figure 4d; then the outer sheath is withdrawn as a whole Outside the human body, the fixed knot 14 and the puller wire 15 remain on the mitral valve annulus, as shown in Figure 4e, to complete the release
  • an inwardly recessed notch 122 is provided on the side wall of the notch channel 121 of the puncture needle 12;
  • the second end of 15 is wound on the outer wall of the fixed knot 14 after going through the notch 122, so as to facilitate the positioning of the fixed knot 14 and the pulling wire 15.
  • the distal end surface of the outer sheath 13 is provided with a fixed head end 11, and the fixed head end 11 is trumpet-shaped from its proximal end toward the distal end, so as to increase the distance between the fixed head end 11 and the
  • the contact area on the annulus of the cusp valve can support the annulus in the direction of the atrium, so as to facilitate the subsequent puncture of the puncture needle 12 .
  • the fixing head 11 is made of medical polymer material, has a certain degree of flexibility, and can protect the annulus from being pierced by the annulus. For example, nickel-titanium alloy or other memory alloy materials can be used.
  • the fixed knot 14 can be in the shape of a spiral tube, that is, a spring-shaped tube; or as shown in FIG. 1 , the fixed knot 14 can also be directly in the shape of a circular tube.
  • the fixed junction 14 is made of polytetrafluoroethylene (ePTFE), or nickel-titanium alloy, or other medical polymers or degradable medical materials, which have a certain amount of deformation, which is convenient for subsequent punctures in place. , forming a ring shape, the arc surface is in contact with the organs of the human body, and will not damage the organs in contact with it.
  • the annulus puncture needle 12 is made of high-strength metal, and the head end is ground at a certain angle.
  • the push sheath 16 is made of metal material or polymer material, preferably, the pulling wire 15 is made of polytetrafluoroethylene (ePTFE) or other polymer material.
  • the ring constriction device of the mitral valve ring in the best implementation mode in this embodiment can be inserted through a small incision while the heart is beating, and the expanded valve ring can be repaired, so as to repair the valve ring between the left ventricle and the left atrium
  • the expanded valve ring can be repaired, so as to repair the valve ring between the left ventricle and the left atrium
  • both the fixed knot 14 and the pulling wire 15 are located in the outer sheath tube 13;
  • the outer sheath tube 13 remains still, and the puncture needle 12, the fixed knot 14, the pulling wire 15 and the pushing sheath 16 are pushed forward together (towards the direction of the left atrium) to puncture the annulus, and the puncture needle 12, the pulling wire 15 and the pushing The sheaths 16 are all punctured on the annulus, and the fixed knot 14 is located on the side of the left atrium, as shown in Figure 4b; after that, the puncture needle 12 is retracted first, and the pushing tube keeps pushing out the proximal end of the fixed knot 14, as shown in Figure 4c shown; subsequently, the pulling force is applied to the puller wire 15, so that the fixed knot 14 is formed into a ring, and the part of the fixed knot 14 located in the left ventricle is tied to be fixed at the position of the annulus puncture point, as shown in Figure 4d, after Withdraw the outer sheath 13 to the outside of the apex of the heart to complete the puncture of the first fixed knot 14, as shown in Figure 4e;
  • the delivery mechanism is used to deliver the locking mechanism 2 to the valve annulus, the outer tube 24 is punctured through the apex of the heart, and delivered to 3 places of the mitral valve annulus, the outer tube 24 stops moving, and the head-hanging sheath tube 23 moves to push the locking main body 21 to the valve annulus.
  • the ends of the pulling wires 15 of the two adjacent fixed knots 14 pass through the locking hole 27 through the first channel of the locking body 21, and then extend toward the proximal end; after that, through three-dimensional ultrasound , Under radiography navigation, apply pulling force to the two pulling wires 15, and adjust the distance between the two annulus fixed knots 14 in real time until the regurgitation disappears, for example, finally adjust the distance between the two fixed knots 14
  • For L2 shorten the circumference of the mitral valve annulus 3, and then realize the reduction of the valve annulus; at this time, push the locking plug 22 to the farthest end of the locking main body 21 by pushing the inner tube 25, and the shrapnel blocks the locking plug 22 function, the puller wire 15 is fixed on the locking main body 21 to complete the contraction of the mitral annulus 3 once, as shown in FIG. Withdraw from the body.
  • multiple pairs of fixation knots 14 can be implanted on the mitral annulus 3 to further reduce the size of the annulus.
  • the number of fixing mechanisms is an even number, and a pair of fixing mechanisms can realize the ring contraction function of the valve annulus.
  • the specific setting number is not limited and can be selected according to actual needs.
  • the knotting position of the two ends of the pulling wire 15 of each fixed knot 14 is close to the position of the annulus, and according to the patient's lesion, the pulling wire 15 can also be tied and fixed at the apex of the heart to complete the annular contraction. Implantation and fixation of the device.

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Abstract

一种二尖瓣瓣环的环缩装置，包括至少两个固定机构、穿刺机构（1）及锁定机构（2）；其中，固定机构包括固定结（14）及牵拉线（15），牵拉线（15）安装在固定结（14）上，且牵拉线（15）的两端均位于固定结（14）的近端外；穿刺机构（1）用于将固定机构的固定结（14）和牵拉线（15）穿刺在瓣环上，并使固定结（14）位于瓣环的一侧，牵拉线（15）的两端位于瓣环的另一侧；相邻两个固定机构的牵拉线（15）在受牵引力的驱动下而相互靠近以缩短相邻两个固定结（14）之间的距离，使相邻两个固定结（14）之间的瓣环部分弯曲或褶皱，减少瓣环的圆周长，锁小瓣环的内孔尺寸；当两个固定结（14）之间的距离调整到位后，采用锁定机构（2）将相邻两个固定机构中的牵拉线（15）的端部锁定在瓣环上，以使瓣环保持在内孔缩小的状态，使瓣环更容易关闭，达到修复效果。

Description

二尖瓣瓣环的环缩装置 技术领域
本申请属于医疗器械的技术领域，具体涉及一种二尖瓣瓣环的环缩装置。
背景技术
人的心脏有四个腔室，同时具有四个瓣膜，四个瓣膜分别为二尖瓣、三尖瓣、主动脉瓣和肺动脉瓣。其中，二尖瓣位于左心房与左心室之间，如同一个单向阀，保证血液循环由左心房向左心室方向流动并通过一定的流量。二尖瓣由瓣叶、瓣环、乳头肌、腱索及交界五部分构成。正常的二尖瓣关闭时，两个瓣叶处在同一个平面且对合密切，能够完全的阻挡左心室血流的回流。二尖瓣功能完整性要求二尖瓣瓣环大小合适、瓣叶结构完整、乳头肌收缩牵拉腱索发挥瓣叶的制成作用、左心室肌肉收缩产关闭力量适当、心室形态及功能正常。若这些因素中的任何一个出现异常都会导致二尖瓣返流，血液从左心室返流到左心房内。
随着社会的发展和人口老龄化，二尖瓣反流的发病率呈明显的上升的态势，目前已成为一种常见的心脏瓣膜疾病，主要是二尖瓣瓣环的关闭不全引起的，因此，需要提供一种对二尖瓣瓣环关闭不全的修复的环缩装置。
发明内容
因此，本申请实际所要解决的技术问题在于提供一种对二尖瓣瓣环关闭不全的修复的环缩装置。
为此，本申请提供的二尖瓣瓣环的环缩装置，包括
至少两个固定机构；任一所述固定机构包括固定结及牵拉线，所述牵拉线安装在所述固定结上，且所述牵拉线的两端均位于所述固定结的近端外；
穿刺机构，用于将任一所述固定机构的所述固定结和牵拉线穿刺在瓣环上，并使所述固定结位于瓣环的一侧，所述牵拉线的两端位于瓣环的另一侧；相邻两个所述固定机构的牵拉线在受牵引力的驱动下而相互靠近以缩短相邻两个所述固定结之间的距离；
锁定机构，用于在相邻两个所述固定机构的牵拉线牵引到位时，将相邻两个固定机构中的牵拉线的端部锁定在瓣环上。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定机构包括
锁定主体，具有沿其长度方向延伸的第一通道；
锁定塞，通过插接在所述第一通道内，将所述牵拉线夹持在所述锁定塞与所述锁定主体之间。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定主体的侧壁上设有供所述牵拉线的端部穿过的锁定孔。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定主体的侧壁上还设有第一安装孔；
还包括至少一个弹性体，其的近端成型在所述第一安装孔内，其的远端在自身变形量的作用下趋于伸入所述第一通道内；
所述锁定塞朝向所述第一通道插接时，所述弹性体受所述锁定塞的外壁的挤压力而朝向所述第一安装孔内摆动；待所述锁定塞越过所述弹性体的远端后，所述弹性体复位且其的远端阻挡在所述锁定塞上。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定塞包括基座及成型在所述基座的远端的外周上的第一环形凸台，所述第一环形凸台对所述弹性体施加所述挤压力；
在所述弹性体复位时，所述弹性体的远端阻挡在所述第一环形凸台的近端一侧。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定主体的远端的内壁上设有向内凸出的第二环形凸台；
所述第一环形凸台的远端受所述第二环形凸台的阻挡而保持在所述第二环形凸台与所述弹性体之间；和/或
所述弹性体为弹片。
可选地，上述的二尖瓣瓣环的环缩装置，所述锁定机构还包括输送机构；所述输送机构包括外管，可滑动地设在所述外管内的挂头鞘管及可滑动地设在挂头鞘管内的推送内管；
所述挂头鞘管的远端与所述锁定主体的近端可拆卸连接，所述推送内管的远端插接或套接配合在所述锁定塞的近端上；在所述锁定主体未释放之前，所述锁定主体和所述锁定塞均位于所述外管内。
可选地，上述的二尖瓣瓣环的环缩装置，所述穿刺机构包括
外鞘管；
穿刺针，可滑动地设在所述外鞘管内，所述穿刺针的远端的外壁上设有沿穿刺针长度方向延伸的豁口通道；
推送鞘，可滑动地设在所述外鞘管内，套在所述穿刺针外；
所述固定结具有收拢在所述外鞘管内的收拢状态和穿刺在所述瓣环上的释放状态；
在收拢状态，所述固定结套在所述穿刺针的豁口通道的外壁上，所述穿刺针的近端与所述推送鞘的远端相对分布；所述牵拉线的第一端位于所述豁口通道内，其的第二端经豁口通道后，从所述固定结的远端处绕在所述固定结的外壁上，并经所述豁口通道的近端伸入所述穿刺针内，以使所述第一端和第二端重叠分布；
在释放状态，所述牵拉线套在所述固定结的侧壁上，所述牵拉线穿刺在瓣环上，所述固定结受所述牵拉线的牵引而弯曲呈环形。
可选地，上述的二尖瓣瓣环的环缩装置，所述穿刺针的豁口通道的侧壁上设有向内凹陷的凹口；在收拢状态，所述固定结的远端套在所述凹口处，所述牵拉线的第二端经所述凹口后绕在所述固定结的外壁上。
可选地，上述的二尖瓣瓣环的环缩装置，所述固定结呈螺旋状或圆管状；和/或
所述外鞘管的远端端面上设有固定头端，所述固定头端由其近端朝向远端呈喇叭状。
本申请技术方案，具有如下优点：
1.本申请提供二尖瓣瓣环的环缩装置，包括至少两个固定机构、穿刺机构及锁定机构；其中，任一所述固定机构包括固定结及牵拉线，牵拉线安装在固定结上，且牵拉线的两端均位于固定结的近端外；穿刺机构用于将任一固定机构的固定结和牵拉线穿刺在瓣环上，并使所述固定结位于瓣环的一侧，所述牵拉线的两端位于瓣环的另一侧；相邻两个所述固定机构的牵拉线在受牵引力的驱动下而相互靠近以缩短相邻两个所述固定结之间的距离，从而使得相邻两个固定结之间的瓣环部分弯曲或褶皱，减少瓣环的圆周长，进而锁小瓣环的内孔尺寸；当两个固定结之间的距离调整到位后，采用锁定机构将相邻两个固定机构中的牵拉线的端部锁定在瓣环上，以使瓣环保持在内孔缩小的状态，由于瓣环的内孔尺寸变小，使瓣环更容易关闭，解决瓣环关闭不全的问题，达到修复效果。
2.本申请提供的二尖瓣瓣环的环缩装置，锁定机构包括锁定主体和锁定塞，锁定主体具有其长度方向延伸的第一通道；锁定塞通过插接在第一通道内，将牵拉线夹持在所述锁定塞与所述锁定主体之间，以实现对相邻两个固定机构的牵拉线进行锁定，以保持两个固定结之间的距离。
3.本申请提供的二尖瓣瓣环的环缩装置，锁定主体的侧壁上设有供所述牵拉线的端 部穿过的锁定孔，确保锁定塞在第一通道内滑动时，牵拉线始终保持穿设在锁定孔内，不会沿第一通道的长度方向滑出第一通道外，进一步确保对牵拉线的锁定作用。
4.本申请提供的二尖瓣瓣环的环缩装置，锁定主体的侧壁上还设有第一安装孔；还包括至少一个弹性体，其的近端成型在所述第一安装孔内，其的远端在自身变形量的作用下趋于伸入所述第一通道内；锁定塞朝向第一通道插接时，弹性体受锁定塞的外壁的挤压力而朝向所述第一安装孔内摆动；待所述锁定塞越过所述弹性体的远端后，弹性体复位且其的远端阻挡在锁定塞上，进一步确保锁定塞插接到位后，即使随着二尖瓣瓣环运动时，不会从锁定主体的近端脱离出来。
附图说明
为了更清楚地说明本申请具体实施方式或现有技术中的技术方案，下面将对具体实施方式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，下面描述中的附图是本申请的一些实施方式，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，还可以根据这些附图获得其他的附图。
图1为本申请实施例1中的二尖瓣瓣环的环缩装置的穿刺机构剖视图；
图2为本申请实施例1中的穿刺机构的另一种实施方式剖视图；
图3为图1中穿刺机构的穿刺针的结构示意图；
图4a为图1中穿刺机构的固定头端固定在瓣环上的状态示意图；
图4b为图1中穿刺机构的穿刺针、推送鞘及固定结穿刺在瓣环后的状态示意图；
图4c为图1中穿刺机构的穿刺针回撤后，推送鞘未回撤的状态示意图；
图4d为图1中穿刺机构的固定结弯曲后的状态示意图；
图4e为图1中整个穿刺机构回撤后的状态示意图；
图5为本申请实施例1中的锁定机构的剖视图；
图6为图5中锁定主体的结构示意图；
图7为图5中锁定主体的结构示意图；
图8a为图5中锁定主体的剖面示意图；
图8b为图8a中锁定主体与牵拉线配合后的剖面示意图；
图9为图5中锁定塞的结构示意图；
图10为二尖瓣瓣环的环缩装置经心尖植入的示意图；
图11a为二尖瓣瓣环的环缩装置穿刺在瓣环上且未锁定的状态示意图；
图11b为二尖瓣瓣环的环缩装置穿刺在瓣环上且处于锁定的状态示意图
图12为二尖瓣瓣环的环缩装置在心房面瓣环位置示意图；
图13为二尖瓣瓣环的环缩装置锁定后瓣环环缩状态示意图；
附图标记说明：
1-穿刺机构；11-固定头端；12-穿刺针；121-豁口通道；122-凹口；13-外鞘管；14-固定结；15-牵拉线；16-推送鞘；
2-锁定机构；21-锁定主体；211-第二环形凸台；212-豁口槽；213-第一安装孔；22-锁定塞；221-第一环形凸台；222-基座；
23-挂头鞘管；24-外管；25-推送内管；26-弹性体；27-锁定孔；3-二尖瓣瓣环。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的 连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
此外，下面所描述的本申请不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
实施例1
本实施例提供一种二尖瓣瓣环的环缩装置，如图1至图13所示，其包括至少两个固定机构、穿刺机构1及锁定机构2。
其中，任一固定机构包括固定结14及牵拉线15，牵拉线15安装在固定结14上，且牵拉线15的两端均位于固定结14的近端外；穿刺机构1用于将任一固定机构的固定结14和牵拉线15穿刺在瓣环上，并使固定结14位于瓣环的一侧(例如，位于左心房一侧)，牵拉线15的两端位于瓣环的另一侧(例如，位于左心室一侧)，如图11a所示；相邻两个固定机构的牵拉线15在受牵引力的驱动下而相互靠近以缩短相邻两个固定结14之间的距离，从而使得相邻两个固定结14之间的瓣环部分弯曲或褶皱，减少瓣环的圆周长，如图11b所示，进而缩小瓣环的内孔尺寸；当两个固定结14之间的距离调整到位后，采用锁定机构2将相邻两个固定机构中的牵拉线15的端部锁定在瓣环上，以使瓣环保持在内孔缩小的状态，由于瓣环的内孔尺寸变小，使瓣环更容易关闭，解决瓣环关闭不全的问题，达到修复效果。
对于锁定机构2而言，优选地，如图5所示，锁定机构2包括锁定主体21和锁定塞22。其中，锁定主体21具有沿其长度方向延伸的第一通道；锁定塞22通过插接在第一通道内，将牵拉线15夹持在锁定塞22与锁定主体21之间，此时牵拉线15的两端需要伸出锁定主体21的近端外，以实现将牵拉线15锁定在锁定主体21上，使两个固定结14调整后的间距得以保持。在锁定过程中，只需锁定塞22从近端朝向远端，将锁定塞22插接在锁定主体21上即可。
进一步优选地，如图7所示，锁定主体21的侧壁上设有供牵拉线15的端部穿过的锁定孔27。在锁定塞22插入锁定主体21之前，牵拉线15的两端先经第一通道后穿过锁定孔27，再通过对牵拉线15施加牵引力，来调整两个固定结14之间的距离，当调整到位后，再将锁定塞22插接在锁定主体21内即可，锁定孔27的设置，无需牵拉线15的两端伸出第一通道的近端外，只需伸出锁定孔27外即可，也便于对牵拉线15施加牵引力。
进一步优选地，如图8a和图6所示，锁定主体21的侧壁上还设有第一安装孔213；锁定机构2还包括至少一个弹性体26，弹性体26的近端成型在第一安装孔213内，其的远端在自身变形量的作用下趋于伸入第一通道内；锁定塞22朝向第一通道插接时，弹性体26受锁定塞22的外壁的挤压力而朝向第一安装孔213内摆动；待锁定塞22越过弹性体26的远端后，弹性体26复位且其的远端阻挡在锁定塞22上，实现对锁定塞22的近端限制在锁定主体21上，避免从锁定主体21的近端上滑落出来。
具体地，如图9所示，锁定塞22包括基座222及成型在基座222的远端的外周上的第一环形凸台221，第一环形凸台221对弹性体26施加挤压力；在弹性体26复位时，弹性体26的远端阻挡在第一环形凸台221的近端一侧，以实现对锁定塞22的阻挡力。作为变形，还可以仅设基座222的远端及第一环形凸台221，第一环形凸台221的端面即作为锁定塞22的近端端面。
锁定主体21和弹性体26一体成型，优选地，采用镍钛合金材料，或者其他医用的可变形的合金材料，或者记忆合金材料。对应弹性体26而言，优选地，弹性体26为弹片，或者弹簧。
对于锁定塞22的材质而言，优选地，采用橡胶材料，以形成橡胶塞，或者其他医用的高分子材料制成。
进一步优选地，如图8a所示和图8b所示，锁定主体21的远端的内壁上设有向内 凸出的第二环形凸台211；第一环形凸台221的远端受第二环形凸台211的阻挡而保持在第二环形凸台211与弹性体26之间。即，当锁定塞22在锁定主体21上滑动到位后，在第二环形凸台211和弹性体26的配合下，将锁定塞22限制在锁定主体21上，锁定塞22不能相对锁定主体21移动，进一步确保对牵拉线15的锁定作用。
对于上述的第一通道、第一安装孔213的形状，最佳地位圆形孔，当然也可以为其他形状的孔，例如矩形孔或椭圆形孔，或者其他形状的孔均可以。
优选地，如图5所示，上述的锁定机构2还包括用于输送锁定主体21和锁定塞22的输送机构；输送机构包括外管24、可滑动地设在外管24内的挂头鞘管23、及可滑动地设在挂头鞘管23内的推送内管25；其中，挂头鞘管23的远端与锁定主体21的近端可拆卸连接，推送内管25的远端插接在锁定塞22的近端内孔中，或者套在锁定塞22的近端外；在锁定主体21未释放之前，锁定主体21和锁定塞22均位于外管24内。
通过外管24的移动，经心尖将整个输送机构输送至二尖瓣瓣环的附近，外管24停止移动，挂头鞘管23推送锁定主体21，使锁定主体21伸出外管24的远端外，挂头鞘管23与锁定主体21分离；牵拉线15的端部穿在锁定孔27内，通过对牵拉线15的端部施加牵拉力，调整两个固定结14之间的距离，待两个固定结14之间的距离调整到位后，推送内管25推送锁定塞插接在锁定主体21内，鉴于弹性体26的限位作用，之后将推送内管25后撤与锁定才分离，最后通过外管24回撤，将整个输送机构撤出人体外。
优选地，如图6所示，锁定主体21的近端上设有对称分布的两个豁口槽212，对应地，挂头鞘管23的远端上设有适于卡接在每一个挂耳豁口内的挂耳(图中未示意出)；在未释放之前，挂耳受外管24的径向约束力，使挂耳保持卡接在豁口槽212内；当挂头鞘管23伸出外管24内，挂耳在自身变形量的作用下复位，趋于朝向外摆动，从豁口槽212内退出，以实现挂头鞘管23与锁定主体21的分离。
对于穿刺机构1而言，如图1、图2及图3所示，穿刺机构1包括外鞘管13、穿刺针12及推送鞘16。其中，穿刺针12可滑动地设在外鞘管13内，穿刺针12的远端外壁上设有沿穿刺针12长度方向延伸的豁口通道121；推送鞘16可滑动地设在外鞘管13内，套在穿刺针外。
固定结14具有收拢在外鞘管13内的收拢状态和穿刺在瓣环上的释放状态；在收拢状态，如图1和图2所示，固定结14套在穿刺针的豁口通道121的外壁上，穿刺针的近端与推送鞘16的远端相对分布；牵拉线15的第一端位于豁口通道121内，其的第二端经豁口通道121后，从固定结14的远端处绕在固定结14的外壁上，并经豁口通道121的近端伸入穿刺针内，以使第一端和第二端重叠分布，牵拉线15的重叠分布的端部可以延伸出穿刺针的近端外，便于操作者对牵拉线15施加牵拉力；或者分布在穿刺针内，与操作机构连接，对牵拉线15施加牵拉力。
当需要释放固定结14时，如图4a所示，外鞘管13的远端端面先抵接在瓣环上，之后穿刺针和推送鞘16同步朝向远端滑动，推送鞘16用于推动固定结14，确保穿刺针和推送鞘16整体穿刺在二尖瓣瓣环上时，固定结14位于二尖瓣靠近心房一侧，如图4b所示；由于豁口通道121的存在，穿刺针与固定结14脱离，先将穿刺针后撤，如图4c所示；之后对牵拉线15施加牵拉力，使固定结14弯曲成环形，如图4d所示；之后外鞘管整体后撤出人体外，固定结14和牵拉线15保持在二尖瓣瓣环上，如图4e所示，以完成固定结14的释放过程；即在释放状态，牵拉线15套在固定结14的侧壁上，牵拉线15穿刺在瓣环上，固定结14受牵拉线15的牵引而弯曲呈环形。
优选地，如图3所示，穿刺针12的豁口通道121的侧壁上设有向内凹陷的凹口122；在收拢状态，固定结14的远端套在凹口122处，牵拉线15的第二端经凹口122后绕在固定结14的外壁上，便于对固定结14和牵拉线15的定位。
进一步优选地，如图1所示，外鞘管13的远端端面上设有固定头端11，固定头端11由其近端朝向远端呈喇叭状，以增大固定头端11在二尖瓣瓣环上的抵接面积，可以 在向心房方向托住瓣环，便于后续穿刺针12的穿刺。优选地，固定头端11采用医用高分子材料制成，具有一定的柔软性，能够保护瓣环不被瓣环穿破。例如，可以采用镍钛合金，或者其他记忆合金材料。
对应固定结14而言，如图2所示，固定结14可以呈螺旋状管，即弹簧状的管；或者如图1所示，固定结14还可以直接呈圆形状管。对于固定结14而言，优选地，固定结14采用聚四氟乙烯(ePTFE)，或者镍钛合金，或者其他医用高分子或可降解的医用材料，具有一定的变形量，便于后续穿刺到位后，形成环形，圆弧面与人体的器官接触，不会损伤与其接触的器官，
另外，优选地，瓣环穿刺针12由高强度的金属制成，头端磨削一定角度。推送鞘16采用金属材料或高分子材料制成，优选地，牵拉线15采用聚四氟乙烯(ePTFE)或者其他高分子材料制成。
本实施例中最佳实施方式的二尖瓣瓣环的环缩装置，可在心脏不停跳下实现小切口插入，修复扩张的瓣环，以对左心室与左心房之间的瓣环修复为例来说明其工作过程：
初始状态，如图1或如图2所示，固定结14和牵拉线15均位于外鞘管13内；
首先，如图10所示，通过心尖穿刺进入左心室，把外鞘管13送至二尖瓣瓣环3下方，通过固定头端11抵接在瓣环上，将瓣环向左心房方向推送，调整好方向使用瓣环固定头端11的远端端面固定住瓣环上的穿刺点，如图4a所示；
然后，外鞘管13保持静止，将穿刺针12、固定结14、牵拉线15及推送鞘16一同向前(朝向左心房方向)推送穿刺瓣环，穿刺针12、牵拉线15及推送鞘16均穿刺在瓣环上，固定结14位于左心房一侧，如图4b所示；之后，先回撤穿刺针12，推送管保持对固定结14的近端的推出，如图4c所示；随后，对牵拉线15施加牵拉力，使固定结14成环形，并且将固定结14位于左心室的部分打结，以固定在瓣环穿刺点位置，如图4d所示，之后回撤外鞘管13至心尖外，完成第一个固定结14的穿刺，如图4e所示；采用相同的方法，在与第一固定结14相距L1的瓣环处，再植入另一个固定结14，即第二固定结14，如图11a所示。
然后，采用输送机构将锁定机构2输送至瓣环处，外管24经心尖穿刺，输送二尖瓣瓣环3处，外管24停止移动，挂头鞘管23移动先将锁定主体21推送至二尖瓣瓣环3的底部，将相邻两个固定结14的牵拉线15的端部经锁定主体21的第一通道穿过锁定孔27后，朝向近端延伸；之后，通过三维超声、造影导航下，对两个牵拉线15施加牵拉力，实时调整两个瓣环固定结14之间的距离，直至反流消失，例如，最终使两个固定结14之间的距离调整为L2，缩短二尖瓣瓣环3的周长，进而实现瓣环的缩小；此时，通过推送内管25将锁定塞22推送至锁定主体21最远端，弹片对锁定塞22起到阻挡作用，将牵拉线15固定在锁定主体21上，完成单次二尖瓣瓣环3的环缩，如图11b所示，最终将外管24、挂头鞘管23及推送内管25整体撤出人体外。
如图12和图13所示，可以采用上述相同的方式，在二尖瓣瓣环3上植入多对固定结14，进一步地缩小瓣环的尺寸。
对于固定机构的设置数量而言，固定机构的数量为偶数个，一对固定机构即可实现瓣环的环缩功能，具体设置数量不做限定，可以根据实际需求来选取。
另外，上述的每个固定结14的牵拉线15的两端的打结位置靠近瓣环的位置，还可以根据患者的病灶，还可以将牵拉线15在心尖处打结固定，完成环缩装置的植入和固定。
显然，上述实施例仅仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。

Claims (10)

  1. 一种二尖瓣瓣环的环缩装置，其特征在于，包括
    至少两个固定机构；任一所述固定机构包括固定结(14)及牵拉线(15)，所述牵拉线(15)安装在所述固定结(14)上，且所述牵拉线(15)的两端均位于所述固定结(14)的近端外；
    穿刺机构(1)，用于将任一所述固定机构的所述固定结(14)和牵拉线(15)穿刺在瓣环上，并使所述固定结(14)位于瓣环的一侧，所述牵拉线(15)的两端位于瓣环的另一侧；相邻两个所述固定机构的牵拉线(15)在受牵引力的驱动下而相互靠近以缩短相邻两个所述固定结(14)之间的距离；
    锁定机构(2)，用于在相邻两个所述固定机构的牵拉线(15)牵引到位时，将相邻两个固定机构中的牵拉线(15)的端部锁定在瓣环上。
  2. 根据权利要求1所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定机构(2)包括
    锁定主体(21)，具有沿其长度方向延伸的第一通道；
    锁定塞(22)，通过插接在所述第一通道内，将所述牵拉线(15)夹持在所述锁定塞(22)与所述锁定主体(21)之间。
  3. 根据权利要求2所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定主体(21)的侧壁上设有供所述牵拉线(15)的端部穿过的锁定孔(27)。
  4. 根据权利要求2或3所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定主体(21)的侧壁上还设有第一安装孔(213)；
    还包括至少一个弹性体(26)，其的近端成型在所述第一安装孔(213)内，其的远端在自身变形量的作用下趋于伸入所述第一通道内；
    所述锁定塞(22)朝向所述第一通道插接时，所述弹性体(26)受所述锁定塞(22)的外壁的挤压力而朝向所述第一安装孔(213)内摆动；待所述锁定塞(22)越过所述弹性体(26)的远端后，所述弹性体(26)复位且其的远端阻挡在所述锁定塞(22)上。
  5. 根据权利要求4所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定塞(22)包括基座(222)及成型在所述基座(222)的远端的外周上的第一环形凸台(221)，所述第一环形凸台(221)对所述弹性体(26)施加所述挤压力；
    在所述弹性体(26)复位时，所述弹性体(26)的远端阻挡在所述第一环形凸台(221)的近端一侧。
  6. 根据权利要求5所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定主体(21)的远端的内壁上设有向内凸出的第二环形凸台(211)；
    所述第一环形凸台(221)的远端受所述第二环形凸台(211)的阻挡而保持在所述第二环形凸台(211)与所述弹性体(26)之间；和/或
    所述弹性体(26)为弹片。
  7. 根据权利要求2-6中任一项所述的二尖瓣瓣环的环缩装置，其特征在于，所述锁定机构(2)还包括输送机构；所述输送机构包括外管(24)，可滑动地设在所述外管(24)内的挂头鞘管(23)及可滑动地设在挂头鞘管(23)内的推送内管(25)；
    所述挂头鞘管(23)的远端与所述锁定主体(21)的近端可拆卸连接，所述推送内管(25)的远端插接或套接配合在所述锁定塞(22)的近端上；在所述锁定主体未释放之前，所述锁定主体和所述锁定塞均位于所述外管(24)内。
  8. 根据权利要求1-7中任一项所述的二尖瓣瓣环的环缩装置，其特征在于，所述穿刺机构(1)包括
    外鞘管(13)；
    穿刺针(12)，可滑动地设在所述外鞘管(13)内，所述穿刺针(12)的远端的外壁上设有沿穿刺针(12)长度方向延伸的豁口通道(121)；
    推送鞘(16)，可滑动地设在所述外鞘管(13)内，套在所述穿刺针外；
    所述固定结(14)具有收拢在所述外鞘管(13)内的收拢状态和穿刺在所述瓣环上的释放状态；
    在收拢状态，所述固定结(14)套在所述穿刺针的豁口通道(121)的外壁上，所述穿刺针的近端与所述推送鞘(16)的远端相对分布；所述牵拉线(15)的第一端位于所述豁口通道(121)内，其的第二端经豁口通道(121)后，从所述固定结(14)的远端处绕在所述固定结(14)的外壁上，并经所述豁口通道(121)的近端伸入所述穿刺针内，以使所述第一端和第二端重叠分布；
    在释放状态，所述牵拉线(15)套在所述固定结(14)的侧壁上，所述牵拉线(15)穿刺在瓣环上，所述固定结(14)受所述牵拉线(15)的牵引而弯曲呈环形。
  9. 根据权利要求8所述的二尖瓣瓣环的环缩装置，其特征在于，所述穿刺针(12)的豁口通道(121)的侧壁上设有向内凹陷的凹口(122)；在收拢状态，所述固定结(14)的远端套在所述凹口(122)处，所述牵拉线(15)的第二端经所述凹口(122)后绕在所述固定结(14)的外壁上。
  10. 根据权利要求8所述的二尖瓣瓣环的环缩装置，其特征在于，所述固定结(14)呈螺旋状或圆管状；和/或
    所述外鞘管(13)的远端端面上设有固定头端(11)，所述固定头端(11)由其近端朝向远端呈喇叭状。
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