WO2021135406A1 - 支撑件及瓣环成形装置 - Google Patents

支撑件及瓣环成形装置 Download PDF

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Publication number
WO2021135406A1
WO2021135406A1 PCT/CN2020/116254 CN2020116254W WO2021135406A1 WO 2021135406 A1 WO2021135406 A1 WO 2021135406A1 CN 2020116254 W CN2020116254 W CN 2020116254W WO 2021135406 A1 WO2021135406 A1 WO 2021135406A1
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WO
WIPO (PCT)
Prior art keywords
rod
base
support
anchor
rods
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Application number
PCT/CN2020/116254
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English (en)
French (fr)
Inventor
谢琦宗
黄桥
张庭超
郭荣辉
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Priority claimed from CN201922502072.7U external-priority patent/CN212346816U/zh
Priority claimed from CN201911426141.9A external-priority patent/CN113116605A/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2021135406A1 publication Critical patent/WO2021135406A1/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

Definitions

  • This application relates to the technical field of medical devices, and in particular to a support and an annuloplasty device.
  • Mitral regurgitation is one of the most common valvular diseases today.
  • the main causes of the disease are mitral valve annulus dilation, chordal dysfunction, mitral valve mucus degeneration, leaflet prolapse, rheumatic heart valve disease, ischemic Lesions and so on.
  • Open mitral valve plasty and prosthetic valve replacement are the most effective methods for the treatment of mitral regurgitation.
  • the trauma to the human body is relatively large, and it is more complicated for elderly patients and patients. In patients with disease, there are quite high complications and mortality.
  • transcatheter annuloplasty is a more effective interventional treatment method, and the main purpose of annuloplasty is to reduce the valve. Ring and maintain the reduced shape of the annulus.
  • the present application provides a support and an annuloplasty device, which can provide a stable supporting force for the anchor, so as to ensure that the anchor can be accurately, completely and firmly anchored into the corresponding position of the annulus.
  • the present application provides a support for anchoring a plurality of anchors into human tissues.
  • the support includes a first base and is arranged at intervals around the circumference of the first base.
  • a base is relatively gathered together, and one of the anchors is correspondingly arranged at the distal end of the supporting rod; one end of the connecting rod is correspondingly connected to one of the supporting rods; the adjusting rod is connected to each of the supporting rods.
  • the opposite end of the rod is rotationally connected; the adjusting rod moves along the axial direction to drive each of the connecting rods to open the corresponding support rod, and the plurality of support rods are opened in an umbrella shape relative to the adjusting rod.
  • the present application also provides an annuloplasty device, including the above-mentioned support, a plurality of anchors corresponding to the distal end of each of the support rods, and a flexible contraction penetrating through the proximal ends of the plurality of anchors. Ring pieces.
  • the support includes a first base, a plurality of support rods, a plurality of connecting rods, and an adjustment rod, and an anchor is provided at the distal end of each support rod,
  • the first base, the plurality of supporting rods, the plurality of connecting rods, and the adjusting rod form a connecting rod structure, and the adjusting rod moves along the axial direction to drive each of the connecting rods to open the corresponding support rod.
  • the plurality of support rods are expanded into an umbrella shape with respect to the adjustment rod.
  • the connecting rod structure makes the positions of the plurality of support rods also be fixed, so that the position of the plurality of support rods can be fixed.
  • the plurality of anchors at the distal end of the support rod provide stable supporting force to ensure that the plurality of anchors can be accurately, completely and firmly anchored into the corresponding positions of the valve annulus.
  • Fig. 1 is a schematic diagram of the three-dimensional structure of the annuloplasty device provided in the first embodiment of the present application stored in a sheath.
  • Fig. 2 is a schematic diagram of the three-dimensional structure of the annuloplasty device in Fig. 1 when the support member extends out of the sheath.
  • Fig. 3 is a schematic diagram of the three-dimensional structure of the annuloplasty device in Fig. 2 when the support is expanded.
  • Fig. 4 is a schematic structural diagram of the support in Fig. 2 when it is in a folded state.
  • Fig. 5 is a schematic structural diagram of the support in Fig. 4 when it is in an expanded state.
  • Fig. 6 is a schematic diagram of the structure when the support in another embodiment is in a folded state.
  • Fig. 7 is a schematic structural diagram of the support in Fig. 6 when it is in an open state.
  • Fig. 8 is a perspective exploded schematic view of the support in Fig. 3.
  • Fig. 9 is an enlarged schematic diagram of part IX in Fig. 8.
  • Fig. 10 is a schematic diagram of the connection between the supporting rod and the connecting rod in Fig. 8.
  • Fig. 11 is an enlarged schematic diagram of part XI in Fig. 10.
  • Fig. 12 is an enlarged schematic diagram of part XII in Fig. 8.
  • Fig. 13 is a schematic diagram of the connection between the support rod and the anchor in Fig. 3.
  • Fig. 14 is an axial cross-sectional view of Fig. 13.
  • Fig. 15 is a perspective exploded schematic view of Fig. 13.
  • Figures 16 and 17 are schematic diagrams of the use process of the annuloplasty device.
  • Fig. 18 is a partial structural diagram of the annuloplasty device provided by the second embodiment of the present application.
  • Fig. 19 is an axial cross-sectional view of the first base in Fig. 18.
  • FIG. 20 is a schematic diagram of the structure of the first base in FIG. 19 and the proximal end of the support rod in a folded state.
  • Fig. 21 is a schematic diagram of the structure of the first base and the proximal end of the support rod in the expanded state in Fig. 19.
  • FIG. 22 is a schematic diagram of the three-dimensional structure of the annuloplasty device provided by the third embodiment of the present application.
  • FIG. 23 is a schematic diagram of the three-dimensional structure of the support rod in FIG. 22.
  • Fig. 24 is a partial cross-sectional view of part XXIV in Fig. 23.
  • the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator;
  • the axial direction refers to the end parallel to the natural The direction of the connection between the distal center and the proximal center of the medical device in the state.
  • the present application provides an annuloplasty device 1000, which includes a delivery catheter 100, a support 200 connected to the distal end of the delivery catheter 100, and each corresponding to the support 200 A plurality of anchors 300 at the distal end of the support rod 220, and a flexible ring member 400 penetrating the proximal end of the plurality of anchors 300.
  • the support 200 is used to provide support for anchoring the plurality of anchors 300 into the annulus tissue.
  • the support 200 includes a first base 210, a plurality of support rods 220 arranged at intervals around the circumference of the first base 210, and a plurality of connections corresponding to the plurality of support rods 220.
  • the rod 230 and the adjusting rod 240 movably passing through the first base 210; wherein, the proximal end of each support rod 220 is relatively gathered at the first base 210, and one of the anchors 300 corresponds to It is arranged at the distal end of a supporting rod 220; one end of the connecting rod 230 is correspondingly rotatably connected to the supporting rod 220; the adjusting rod 240 is rotatably connected to the opposite end of each connecting rod 230.
  • the first base 210 of the supporting member 200, the plurality of supporting rods 220, the plurality of connecting rods 230, and the adjusting rod 240 form a connecting rod structure, so that the movement of the adjusting rod 240 in the axial direction can drive each A connecting rod 230 expands the corresponding support rod 220, and the plurality of support rods 220 are expanded into an umbrella shape relative to the adjusting rod 240.
  • the connecting rod structure is fixed, and the positions of the plurality of support rods 220 are also fixed, so as to provide a stable supporting force for the plurality of anchors 300 arranged at the distal ends of the plurality of support rods 220 to ensure all The multiple anchors 300 can be accurately, completely and firmly anchored into the corresponding positions of the annulus tissue.
  • the annuloplasty device 1000 is movably installed in the sheath tube 2000 to enter the human heart through the inner cavity of the sheath tube 2000.
  • the adjusting rod 240 movably passes through the inner cavity of the delivery catheter 100, and extends outside the patient's body to be connected to a corresponding drive control member (not shown in the figure) on the operating handle ,
  • the relative position of the adjusting rod 240 can be controlled by the driving control member, so that the plurality of supporting rods 220 can be opened and fixed, thereby providing a stable supporting force.
  • the support 200 further includes a second base 250, which is fixedly connected to the distal end of the adjusting rod 240, and each of the connecting rods 230 An end opposite to one end of the supporting rod 220 corresponding to the rotational connection is rotationally connected to the second base 250 at the other end.
  • the second base 250 follows the adjusting rod 240 to move in the axial direction to move away from or close to the first base.
  • a base 210, the second base 250 drives each of the connecting rods 230 to push or pull the corresponding support rod 220 to move, and the support rod 220 is gathered relative to the first base 210
  • One end is the base point of rotation and is opened or closed relative to the adjusting rod 240.
  • the overall structure of the supporting member 200 is configured as follows: when the supporting rod 220 is folded relative to the adjusting rod 240, the supporting member When 200 is in the folded state, as shown in FIG. 4, the axial distance between the second base 250 and the first base 210 is greater than that of the connecting rod 230 connected to the corresponding supporting rod 220. The axial distance between the first bases 210 is described. As shown in FIG.
  • the second base 250 approaches the first base 210, and the second base 250 drives each of the connections
  • the rod 230 expands the corresponding supporting rod 220, and each of the supporting rods 220 is expanded relative to the adjusting rod 240.
  • the second base 250 and the adjusting rod 240 may be an integral structure or a non-integral structure.
  • the second base 250 and the adjusting rod 240 are of a non-integral structure but are fixedly connected to each other. .
  • the overall structure of the supporting member 200 may also be configured such that when the supporting rod 220 is folded relative to the adjusting rod 240, the second base 250 is The axial distance between the first bases 210 is smaller than the axial distance between the end of the connecting rod 230 connected to the corresponding support rod 220 and the first base 210.
  • the second base 250 when the adjusting rod 240 moves to the distal end in the axial direction, the second base 250 is away from the first base 210, and the second base 250 drives each of the connections
  • the rod 230 expands the corresponding supporting rod 220, and each of the supporting rods 220 expands into an umbrella shape relative to the adjusting rod 240.
  • the adjusting rod 240 moves different distances in the axial direction, so that each of the support rods 220 can be opposed to each other. Since the opening angle of the adjusting rod 240 is different, therefore, the radial distance between the anchor 300 provided at the distal end of the supporting rod 220 and the adjusting rod 240 (that is, along the direction perpendicular to the adjusting rod 240) is different. After the anchors 300 are anchored into the annulus tissue, the radius of the ring enclosed by the anchors 300 is also different.
  • the expansion angle of the supporting member 200 can be adjusted, so that the plurality of anchors 300 arranged on the supporting member 200 form a circular ring
  • the radius of the shape can adapt to different annulus sizes.
  • the expansion angle of the supporting member 200 is adjusted so that the ring formed by the plurality of anchors 300 provided on the supporting member 200 After the radius of the shape is at a suitable radius value, the position of the adjusting rod 240 can be controlled by the drive control member to be relatively fixed as described above.
  • the positions of the plurality of support rods 220 are fixed, and in turn, the plurality of anchors provided at the distal ends of the plurality of support rods 220 300 provides a stable supporting force to ensure that the plurality of anchors 300 can be accurately, completely and firmly anchored into the corresponding positions of the annulus tissue.
  • first base 210, the plurality of supporting rods 220, the plurality of connecting rods 230, and the adjusting rod 240 may be connected to each other through different connection methods to form a connecting rod structure.
  • each component is preferably made of metal materials such as stainless steel.
  • the proximal end of the support rod 220 is rotatably connected with the first base 210.
  • the first base 210 is substantially in the shape of a round pie, and a plurality of first connecting grooves 211 are formed on the outer peripheral surface of the first base 210 at intervals around the circumference, and each of the first connecting grooves 211 is correspondingly accommodated
  • a first connection buckle 510, the first connection buckle 510 is rotatably connected to the first base 210, and the proximal end of each support rod 220 is correspondingly connected to the first connection buckle 510.
  • the first connecting groove 211 is a U-shaped groove penetrating both ends of the first base 211, and the opening of the U-shaped groove faces the outer peripheral edge of the first base 211.
  • the first connecting buckle 510 includes a circular ring body 511 and a flat connecting body 513 connected to the outer peripheral surface of the circular ring body 511.
  • the connecting body 513 is provided with a through hole 515.
  • a circle of first annular grooves 213 communicating with the plurality of first connecting grooves 211 are provided on the outer peripheral surface of the first base 210 along the circumferential direction, and a first annular hoop is embedded in the first annular groove 213 215.
  • the first annular hoop 215 is inserted through the insertion hole 515 of each of the first connecting buckles 510, so that the plurality of first connecting buckles 510 are movably sleeved on the first annular hoop 215 , And the connecting body 513 of the first connecting buckle 510 is received in the first connecting groove 211.
  • the two opposite inner wall surfaces of the first connecting groove 211 stop at the two opposite outer wall surfaces of the connecting body 513 of the first connecting buckle 510, so that the first connecting buckle 510 can only go around the first ring shape.
  • each of the supporting rods 220 can be rotatably connected to the first base 210 through a first connecting buckle 510, and a plurality of supporting rods 220 can be relatively gathered or assembled with the first base 210 as a node. Divergence.
  • proximal end of the support rod 220 and the first connecting buckle 510 may be fixedly connected by threaded connection or laser welding. In this embodiment, laser welding is preferred.
  • a first connecting portion 260 is further provided on the proximal surface of the first base 210, and the first connecting portion 260 is used to connect with the distal end of the delivery catheter 100 so as to pass through the delivery catheter 100.
  • the support 200 is transported.
  • the first base 210 is provided with a through hole along the axial direction, and the through hole communicates with the inner cavity of the first connecting portion 260 for the adjustment rod 240 to pass through.
  • each connecting rod 230 is correspondingly connected to a second connecting buckle 520 by rotation, and each second connecting buckle 520 is correspondingly sleeved on a supporting rod 520, so that a supporting rod 220 and a connecting rod 230 are rotatably connected.
  • the second connecting buckle 520 is located between the proximal end and the distal end of the support rod 220, and the second connecting buckle 520 is fixedly sleeved on the support rod 220 by means of laser welding or crimping.
  • the support rod 220 is on.
  • the structure of the second connecting buckle 520 is similar to that of the first connecting buckle 510, except that the ring body of the second connecting buckle 520 is fixedly connected with a pair of spaced connections.
  • a connecting groove is formed between the pair of connecting bodies, and the end of one end of the connecting rod 230 is accommodated in the connecting groove and is rotatably connected to the second connecting buckle 520 by a pin.
  • the connecting rod 230 is a flat rod body, both ends of which are provided with connecting holes 231, and both ends are smoothed.
  • each connecting rod 230 opposite to the end of the supporting rod 220 corresponding to the rotational connection is rotationally connected with the second base 250.
  • the structure of the second base 250 is similar to the structure of the first base 210.
  • the second base 250 is substantially in the shape of a round pie, and a plurality of U-shaped second connecting grooves 252 passing through the two end surfaces of the second base 250 are provided on the outer peripheral surface of the second base 250 at intervals around the circumference.
  • a second annular groove 254 connected with the plurality of second connecting grooves 252 is provided on the outer peripheral surface of the second base 250 along the circumferential direction, and the second annular hoop 256 is embedded in the second annular groove 254, The second annular hoop 256 passes through the connecting hole 231 of each connecting rod 230, so that the other end of each connecting rod 230 is movably sleeved on the second annular hoop 256, thereby The other end of each connecting rod 230 is rotatably connected with the second base 250, and a plurality of connecting rods 230 can be relatively gathered or diverged with the second base 250 as a node.
  • the proximal surface of the second base 250 is provided with a connecting hole along the axial direction, and the distal end of the adjusting rod 240 is fixedly connected to the connecting hole.
  • the fixed connection method includes but not limited to threaded connection and laser welding. In this case, laser welding is preferred.
  • the first annular hoop 215 and the second annular hoop 256 can be fitted with the plurality of first connecting buckles 510 or the plurality of connecting rods respectively by a piece of metal wire. After 230, the two ends of the metal wire are fixed by welding, crimping or sleeved in a connecting sleeve to form an integral ring hoop.
  • the metal wire includes but is not limited to stainless steel wire, nickel-titanium metal wire and other biological phases. Capacitive wire.
  • the first annular hoop 215 and the second annular hoop 256 can also be made of polymer materials.
  • the first base 210, the plurality of support rods 220, the plurality of connecting rods 230 that are rotatably connected to the plurality of support rods 220, the second base 250, and the adjustment rods 240 forms a connecting rod structure.
  • the adjusting rod 240 is driven to move in the axial direction, the plurality of supporting rods 220 will be driven to show an opening and closing movement relative to the adjusting rod 240.
  • each support rod 220 When the adjusting rod When the position of 240 is fixed (controlled by the aforementioned drive control member), the opening and closing angles of the plurality of support rods 220 will also be fixed to form a lock, so that the anchors corresponding to the distal end of each support rod 220 can be realized
  • the rigid support function of 300 ensures that each anchor 300 can be accurately, completely and firmly anchored into the corresponding position of the annulus tissue.
  • the support 200 further includes a plurality of telescopic structures corresponding to the plurality of support rods 220, and one of the telescopic structures is used to adjust the proximal end of the anchor 300 and the anchor 300 correspondingly.
  • the axial distance between the first bases 210 that is, the distance along the axial direction of the adjusting rod 240).
  • the support rod 220 is a hollow rod body, and its cross-sectional shape includes, but is not limited to, a circle, an oblate, a rectangle, a polygon, etc., preferably Adopt a round shape.
  • An anchor control rod 310 and an anchor joint 330 fixedly connected to the distal end of the anchor control rod 310 are movably pierced in the inner cavity of the support rod 220, and the anchor joint 330 and the anchor 300 are detachable Connection; the anchor control rod 310 and the anchor joint 330 constitute the telescopic structure, the anchor 300 follows the movement of the anchor control rod 310 along its axial direction to change the proximity of the anchor 300 The axial distance between the end and the first base 210, the anchor 300 rotates following the rotation of the anchor control rod 310 to anchor the annulus tissue.
  • the diameter of the distal end of the anchor joint 310 is larger than the inner diameter of the support rod 220 so that the anchor 300 is located outside the distal end of the support rod 220.
  • the anchor control rod 310 can be extended to the outside of the patient through the lumen of the delivery catheter 100 and connected with the corresponding control mechanism (not shown in the figure) on the operating handle, so that the control mechanism can be used to control the control mechanism.
  • the anchor control rod 310 moves along the axial direction to drive the anchor 300 to extend or retract from the distal end of the support rod 220.
  • each of the anchors 300 can be controlled to extend different distances relative to the distal end of the support rod 220 by the control mechanism, so that the plurality of anchors 300 When anchoring the valve annulus tissue, it can adapt to the unevenness of different areas of the valve annulus tissue.
  • the ring shrink member 400 is not on a plane, but adapts to the real 3D physiological structure of the valve annulus tissue similar to the saddle shape, so as to achieve a better ring shrinking effect.
  • the support 200 is connected to the distal end of the delivery catheter 100 so that the support 200 can pass through when the support 200 is in the collapsed state.
  • the delivery catheter 100 pushes the support 200, and as described above, the adjusting rod 240 and the anchor control rod 310 of the support 200 extend to the outside of the body through the lumen of the delivery catheter 100 together.
  • the delivery catheter 100 is a multi-lumen catheter, and the delivery catheter 100 includes a main sub-lumen extending in the axial direction and a number of auxiliary sub-lumens spaced around the circumference of the main sub-lumen. .
  • the main sub-cavity is used for the adjustment rod 240 to pass through, and each of the auxiliary sub-cavities is used for the anchor control rod to pass through.
  • the flexible ring member 400 is simultaneously pierced on the proximal ends of the plurality of anchors 300 at the distal end of the support member 200, and after the plurality of anchors 300 are anchored into the annulus tissue, they are retracted Tightening the flexible ring member 400 can shrink the annulus to an appropriate degree.
  • the flexible ring-reducing member 400 may be a closed-loop structure or an open-loop structure.
  • the flexible ring-reducing member 400 adopts a closed-loop structure, and the flexible ring-reducing member 400 of the closed-loop structure is tightened to be used for shrinking.
  • the closed ring of the annulus the force is more even when the annulus is contracted, and the effect of fixing the shape of the valve orifice is better.
  • the flexible ring-shrinking member 400 includes but is not limited to a flexible wire, a flexible strip or a flexible belt, and the cross-sectional shape of the flexible strip or the flexible belt includes but is not limited to a flat circle, a rectangle, and the like.
  • the use process of the annuloplasty device 2000 provided in this embodiment is as follows: First, the supporting rods 220 of the supporting member 200 are relatively gathered together, and the flexible ring member 400 In the initial state of being collapsed, the delivery catheter 100 pushes the channel established by the support 100 in the sheath 1000 (the outer sheath is shown as examples through the femoral vein, inferior vena cava, right atrium, atrial septum, and left atrium.
  • the control member drives the adjusting rod 240 to move in the axial direction to drive the support rods 220 to expand into an umbrella shape, and then the control mechanism of the operating handle is rotated one by one or at the same time to control the anchors inserted in each support rod 220.
  • the rod 310 rotates to drive each of the anchors 300 to rotate, so that each of the anchors 300 is anchored into the annulus tissue; finally, the flexible ring members 400 that are installed on the plurality of anchors 300 are tightened , Complete the shrink ring.
  • the control mechanism of the operating handle can also drive each of the anchor control rods 310 to move in the axial direction, so as to change the proximity of each anchor 300.
  • the axial distance between the end and the first base 210 is such that after the plurality of anchors 300 are anchored, the proximal ends of the anchors are on different horizontal planes, so that the anchors are inserted into the plurality of anchors.
  • the flexible ring-reducing member 400 at the proximal end of 300 is not on a plane, which is beneficial to adapt to the true 3D physiological structure of the annulus tissue similar to the saddle shape, and achieve a better ring-shrinking effect.
  • the annuloplasty device 1000 provided in this embodiment has the following beneficial effects during the process of shrinking the ring: 1.
  • the support 200 can provide a reliable and rigid support for a plurality of anchors 300, so that the plurality of anchors 300
  • the anchor 300 can be stably anchored into the annulus tissue; 2.
  • the multiple anchors 300 are sent to the mitral valve annulus at the same time, which makes the operation more convenient; 3.
  • each support rod 220 By controlling the distance that the adjustment rod 240 moves in the axial direction, The degree to which each support rod 220 is stretched can be adjusted, so that the radius of the circular ring enclosed by the plurality of anchors 300 provided at the distal end of each support rod 220 is different, which can adapt to the physiological anatomy of the valve annulus of different individuals; 4
  • the flexible ring-reducing member 300 adopts a closed-loop structure after being tightened to form a closed ring for the ring-shrinking, which is more uniform when contracting the annulus than an open ring, and has a better effect on the shape of the valve orifice; 5.
  • the arrangement of the retractable structure can make the flexible ring member 400 inserted on the proximal end of the multiple anchors 300 complete the anchoring to adapt to the real 3D physiological structure of the annulus tissue similar to the saddle shape, and achieve better The shrinking ring effect.
  • the structure of the annuloplasty device provided by the second embodiment of the present application is similar to the structure of the annuloplasty device 1000 of the first embodiment, except that: in the second embodiment , The first base 210b is provided with a plurality of accommodating cavities 212 passing through the proximal and distal surfaces of the first base 210b at intervals around the circumference, and the proximal end of each support rod 220 is movably penetrated In a corresponding accommodating cavity 212, the accommodating cavity 212 includes a proximal limiting section, and the axis of the proximal limiting section is gradually away from the axis of the first base 210b from the proximal end to the distal end.
  • the distal end portion of the receiving cavity 212 penetrates the distal end surface of the first base 210b and the distal end portion of the outer peripheral surface at the same time, so that the receiving cavity 212 has a larger distal end. Space for events.
  • the support rod 220 When the adjusting rod 240 (not shown in the figure) moves in the axial direction to drive each of the connecting rods 230 (not shown in the figure) to open the corresponding support rod 220, the support rod 220 has an edge along the The tendency of the first base 210b to move radially outward, the proximal end of the support rod 220 abuts against the inner wall of the proximal limit section, at this time, if the connecting rod 230 further expands the The support rod 220, the proximal end of the support rod 220 no longer moves in the radial direction under the stop of the proximal limit section, but the part of the support rod 220 far away from the proximal end is at the end of the connecting rod 230 Continue to move outward while being pushed, so that the support rod 220 will open relative to the adjustment rod 240 with its proximal end as the base point of rotation, and the distal end of the receiving cavity 212 is the opening and closing of the support rod 220 The movement
  • the first base 210b is provided with a through hole 214 along the axial direction for the adjustment rod 240 to pass through.
  • each of the supporting rods 220 will not be separated from the receiving cavity 212.
  • each support rod 220 is movably inserted into the receiving cavity 212 of the first base 210b, and the first connecting buckle 510 and the first ring hoop in the first embodiment are not required 215, making the structure of the support and the entire annuloplasty device simpler and easy to install.
  • the structure of the annuloplasty device 1000c provided by the third embodiment of the present application is similar to the structure of the annuloplasty device of the second embodiment, except that: in the third embodiment , Without the anchor control rod and anchor joint, the anchor 300 is directly detachably connected to the distal end of the support rod 220c, the support rod 220c is provided with an external thread extending along its axial direction, and the second connection buckle 520c is provided with internal threads, each of the second connecting buckles 520c is correspondingly screwed and sleeved on a supporting rod 220c, and the second connecting buckles 520c and the external threads on the supporting rod 220c constitute the telescopic structure.
  • the anchor 300 rotates synchronously with the rotation of the supporting rod 220c And will move along the axial direction of the support rod 220c to change the axial distance between the proximal end of the anchor 300 and the first base 210c (that is, along the axial direction of the first base 210c) distance).
  • the support rod 220c is a solid rod with a slot 350 provided at its distal end, and the proximal end of the anchor 300 is inserted into the slot 350, so that the support rod 220c Rotation can drive the anchor 300 to rotate.
  • the second connecting buckle 520c is screwed and sleeved on the supporting rod 220c, and the second connecting buckle 520c is also rotatably connected with a corresponding connecting rod 230.
  • the supporting rod 220c rotates, due to The second connecting buckle 520c is restricted by the connecting rod 230. Therefore, the supporting rod 220c can move in its own axial direction relative to the second connecting buckle 520c, thereby driving the anchor 300 at the distal end along the support The axial movement of the rod 220c.
  • the proximal end of the support rod 220c is movably inserted into the receiving cavity 212 of the first base 210c, and the proximal end of the support rod 220c can be connected to the sub-cavity of the delivery catheter 100
  • the corresponding control mechanism (such as a serpentine tube, etc.) can rotate the support rod 220c through the control mechanism, and under the pulling of the control mechanism, the proximal end of the support rod 220c will not self-receive from the receiving cavity 212 Detached from within.
  • each support rod 220c when each support rod 220c is expanded into an umbrella shape, the different support rods 220c are controlled by the control mechanism to rotate differently relative to the second connecting buckle 520c that is screwed to it.
  • the number of turns can drive multiple anchors 300 to undergo different degrees of axial expansion and contraction, so that when multiple anchors 300 are anchored into the annulus tissue, they can adapt to the unevenness of different areas of the annulus tissue.
  • the flexible ring member 400 inserted on the proximal ends of the anchors 300 is not on a plane, but can adapt to the true saddle-shaped annulus tissue.
  • the 3D physiological structure can achieve a better ring reduction effect.
  • each of the supporting rods 220c when the outer circumference of the first base 210c is provided with a plurality of first connecting grooves 211 spaced in the circumferential direction, each of the supporting rods 220c When the proximal end is rotatably connected to the first base 210c through a first connecting buckle, in order to prevent the first connecting buckle from obstructing the rotation of the support rod 220c, an internal thread is correspondingly provided in the first connecting buckle, and each The proximal end of the supporting rod 220c is screwed to the first connecting buckle 510c, so that when the supporting rod 220c is driven to rotate by the control mechanism, the supporting rod 220c is simultaneously relative to the first connecting buckle and the first connecting buckle.
  • the second connecting buckle 520c moves along its own axial direction, thereby driving the anchor 300 at the distal end of the support rod 220c to move along the axial direction of the support rod 220c, which can also change the proximal end of each anchor 300 and
  • the axial distance between the first bases 210c is such that after the plurality of anchors 300 are anchored into the annulus tissue, the flexible ring member 400 inserted on the proximal end of the plurality of anchors 300 is not on a plane , But can adapt to the real 3D physiological structure of the annulus tissue similar to the saddle shape to achieve a better ring reduction effect.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
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Abstract

一种支撑件（200），包括第一基座（210）、绕第一基座（210）的周向间隔设置的多个支撑杆（220）、与多个支撑杆（220）对应设置的多个连接杆（230），以及活动穿过第一基座（210）的调节杆（240）。每一支撑杆（220）的近端于第一基座（210）处相对聚拢，一锚钉（300）对应设于一支撑杆（220）的远端。一连接杆（230）的一端对应转动连接一支撑杆（220），调节杆（240）与每一连接杆（230）相对的另一端转动连接。支撑件（200）的第一基座（210）、多个支撑杆（220）、多个连接杆（230）及调节杆（240）形成连杆结构，使得调节杆（240）沿轴向移动可以驱使每一连接杆（230）将对应的支撑杆（220）撑开，多个支撑杆（220）相对于调节杆（240）张开成伞状，当调节杆（240）的位置相对固定时，各支撑杆（220）的位置也会固定，从而为设于各支撑杆（220）远端的多个锚钉（300）提供稳定的支撑力。本申请还提供一种包括该支撑件（200）的瓣环成形装置（1000）。

Description

支撑件及瓣环成形装置 技术领域
本申请涉及医疗器械技术领域，尤其涉及一种支撑件及瓣环成形装置。
背景技术
二尖瓣关闭不全是当今最常见的瓣膜病变之一，病变原因主要有二尖瓣环扩张、腱索功能不全、二尖瓣粘液变性、瓣叶脱垂、风湿性心瓣膜病、缺血性病变等。二尖瓣直视成形术及人工瓣膜置换术是治疗二尖瓣关闭不全的最有效方法，但是由于手术需要体外循环技术支持，给人体带来的创伤比较大，对高龄患者和有较多合并症患者，有相当高的并发症和死亡率。
近年来，各国的医务人员和科研人员进行了经导管二尖瓣修复技术的诸多探索，其中，经导管瓣环成形术是一种较为有效的介入治疗方式，瓣环成形术的主旨为缩小瓣环以及保持瓣环缩小后的形状。
现有技术中，有一种用于缩环的可膨胀的镍钛支架，该镍钛支架的边缘埋设有数个锚钉，将所述数个锚钉分别锚入二尖瓣环上，再通过收缩该镍钛支架从而达到缩环的目的。由于在锚入锚钉的过程中，心脏是不停地跳动的，镍钛支架是靠镍钛金属材料的弹性记忆功能为锚钉提供支撑力，然而，这种支撑力较小且不稳定，难以确保锚钉能够准确、完整、牢靠地锚入瓣环的相应位置。
发明内容
针对现有技术的不足，本申请提供一种支撑件及瓣环成形装置，能够为锚钉提供稳定的支撑力，从而确保锚钉能够准确、完整、牢靠地锚入瓣环的相应位置。
为解决上述技术问题，本申请提供一种支撑件，用于为多个锚钉锚入人体组织提供支撑，所述支撑件包括第一基座、绕所述第一基座的周向间隔设置的多个支撑杆、与所述多个支撑杆对应设置的多个连接杆，以及活动穿过所述第一基座的调节杆；其中，每一所述支撑杆的近端于所述第一基座处相对聚拢，一所述锚钉对应设于一所述支撑杆的远端；一所述连接杆的一端对应转动连接一所述支撑杆；所述调节杆与每一所述连接杆相对的另一端转动连接；所述调节杆沿轴向移动以驱使每一所述连接杆将对应的支撑杆撑开，所述多个支撑杆相对于所述调节杆张开成伞状。
本申请还提供一种瓣环成形装置，包括上述的支撑件、对应设于各所述支撑杆的远端的多个锚钉以及穿设于所述多个锚钉的近端上的柔性缩环件。
本申请提供的支撑件及瓣环成形装置，所述支撑件包括第一基座、多个支撑杆、多个连接杆以及一调节杆，每一所述支撑杆的远端设有一锚钉，所述第一基座、多个支撑杆、多个连接杆及调节杆形成连杆结构，所述调节杆沿轴向移动以驱使每一所述连接杆将对应的支撑杆撑开，所述多个支撑杆相对于所述调节杆张开成伞状，当所述调节杆的位置相对固定时，连杆结构使得所述多个支撑杆的位置也会固定，从而能够为设于所述多个支撑杆远端的多个锚钉提供稳定的支撑力，以确保所述多个锚钉能够准确、完整、牢靠地锚入瓣 环的相应位置。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对实施方式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是本申请第一实施例提供的瓣环成形装置收纳于鞘管中的立体结构示意图。
图2是图1中的瓣环成形装置的支撑件伸出鞘管时的立体结构示意图。
图3是图2中的瓣环成形装置在支撑件撑开状态下的立体结构示意图。
图4是图2中的支撑件处于收拢状态时的结构简图。
图5是图4中的支撑件处于撑开状态时的结构简图。
图6是另一实施方式中的支撑件处于收拢状态时的结构简图。
图7是图6中的支撑件处于张开状态时的结构简图。
图8是图3中的支撑件的立体分解示意图。
图9是图8中IX部分的放大示意图。
图10是图8中支撑杆与连接杆的连接示意图。
图11是图10中XI部分的放大示意图。
图12是图8中XII部分的放大示意图。
图13是图3中的支撑杆与锚钉的连接示意图。
图14是图13的轴向剖视图。
图15是图13的立体分解示意图。
图16及图17是瓣环成形装置的使用过程示意图。
图18是本申请第二实施例提供的瓣环成形装置的局部结构示意图。
图19是图18中的第一基座的轴向剖视图。
图20是图19中的第一基座与收拢状态下的支撑杆的近端的结构示意简图。
图21是图19中的第一基座与撑开状态下的支撑杆的近端的结构示意简图。
图22是本申请第三实施例提供的瓣环成形装置的立体结构示意图。
图23是图22中的支撑杆的立体结构示意图。
图24是图23中XXIV部分的局部剖视图。
具体实施方式
下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅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付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，术语“上”、“下”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或者暗示所指的装置或者元件必须具有特定的方位、以特定的方位构造和操作， 因此不能理解为对本申请的限制。此外，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，在介入医疗器械领域，近端是指距离操作者较近的一端，而远端是指距离操作者较远的一端；轴向是指平行于自然状态下的医疗器械远端中心和近端中心连线的方向。上述定义只是为了表述方便，并不能理解为对本申请的限制。
请一并参阅图1至图3，本申请提供一种瓣环成形装置1000，包括输送导管100、连接于所述输送导管100远端的支撑件200、对应设于所述支撑件200的各支撑杆220远端的多个锚钉300，以及穿设在所述多个锚钉300近端上的柔性缩环件400。所述支撑件200用于为所述多个锚钉300锚入瓣环组织提供支撑。
具体地，所述支撑件200包括一第一基座210、绕所述第一基座210的周向间隔设置的多个支撑杆220、与所述多个支撑杆220对应设置的多个连接杆230，以及活动穿过所述第一基座210的调节杆240；其中，每一所述支撑杆220的近端于所述第一基座210处相对聚拢，一所述锚钉300对应设于一所述支撑杆220的远端；一所述连接杆230的一端对应转动连接一所述支撑杆220；所述调节杆240与每一所述连接杆230相对的另一端转动连接。本申请中，所述支撑件200的第一基座210、多个支撑杆220、多个连接杆230以及调节杆240形成连杆结构，使得所述调节杆240沿轴向的移动可以驱使每一所述连接杆230将对应的支撑杆220撑开，所述多个支撑杆220相对于所述调节杆240张开成伞状，可以理解的是，当所述调节杆240的位置相对固定时，所述连杆结构即固定，所述多个支撑杆220的位置也即固定，从而能够为设于所述多个支撑杆220远端的多个锚钉300提供稳定的支撑力，以确保所述多个锚钉300能够准确、完整、牢靠地锚入瓣环组织的相应位置。
需要说明的是，所述瓣环成形装置1000活动穿设于鞘管2000中，以通过所述鞘管2000的内腔进入人体心脏内。所述调节杆240穿过所述第一基座210后活动穿设于所述输送导管100的内腔中，并延伸至患者体外与操作手柄上相应的驱动控制件(图中未示)连接，通过所述驱动控制件即可控制所述调节杆240的相对位置，以使所述多个支撑杆220张开并固定，进而提供稳定的支撑力。
具体地，如图3所示，所述支撑件200还包括一第二基座250，所述第二基座250与所述调节杆240的远端固定连接，每一所述连接杆230的与转动连接对应的支撑杆220的一端相对的另一端转动连接所述第二基座250。当所述调节杆240沿轴向在所述第一基座210及所述输送导管100中移动时，所述第二基座250跟随所述调节杆240沿轴向移动以远离或者靠近所述第一基座210，所述第二基座250带动每一所述连接杆230顶推或牵拉对应的支撑杆220运动，所述支撑杆220以其相对于所述第一基座210聚拢的一端为转动基点而相对于所述调节杆240张开或者收拢。具体地，请一并参阅图4及图5，本实施例中，所述支撑件200的整体结构被配置为：所述支撑杆220相对于所述调节杆240收拢时，即所述支撑件200处于收拢状态时，如图4所示，所述第二基座250与所述第一基座210之间的轴向距离大于所述连接杆230连接于对应的支撑杆220的一端与所述第一基座210之间的轴向距离。如图5所示，当所述调节杆240沿轴向向近端移动时，所述第二基座250靠近所述第一基座210，所述第二基座250带动每一所述连接杆230将对应的支撑杆220撑开，每一所述支撑杆220即相对于所述调节杆240张开。其中，所述第二基座250与所 述调节杆240可以是一体结构或者非一体结构，本实施例中，所述第二基座250与所述调节杆240是非一体结构而是相互固定连接。
如图6所示，在其他实施例中，所述支撑件200的整体结构也可以被配置为：所述支撑杆220相对于所述调节杆240收拢时，所述第二基座250与所述第一基座210之间的轴向距离小于所述连接杆230连接于对应的支撑杆220的一端与所述第一基座210之间的轴向距离。如图7所示，当所述调节杆240沿轴向向远端移动时，所述第二基座250远离所述第一基座210，所述第二基座250带动每一所述连接杆230将对应的支撑杆220撑开，每一所述支撑杆220即相对于所述调节杆240张开成伞状。
可以理解的是，在上述任一种实施方式中，所述支撑件200的初始状态为收拢状态时，所述调节杆240沿轴向移动不同的距离，可使每一所述支撑杆220相对于所述调节杆240的张开角度不同，由此，对应设于所述支撑杆220远端的锚钉300相对于所述调节杆240的径向距离(即沿垂直于所述调节杆240的轴向的方向上的距离)不同，所述多个锚钉300的锚入瓣环组织后，所述多个锚钉300围成的圆环形的半径也即不同。换句话说，通过控制所述调节杆240沿轴向的移动距离，可调节所述支撑件200的撑开角度，使得设于所述支撑件200上的多个锚钉300围成的圆环形的半径能够适应不同的瓣环大小。
进一步的，当通过控制所述调节杆240沿轴向的移动距离，调节好所述支撑件200的撑开角度，使得设于所述支撑件200上的多个锚钉300围成的圆环形的半径处于合适的半径值后，即可如前所述通过驱动控制件控制所述调节杆240的位置相对固定，在所述第一基座210、多个支撑杆220、多个连接杆230以及第二基座250与调节杆240形成的连杆结构的作用下，使所述多个支撑杆220的位置固定，进而为设于所述多个支撑杆220远端的多个锚钉300提供稳定的支撑力，以确保所述多个锚钉300能够准确、完整、牢靠地锚入瓣环组织的相应位置。
其中，所述第一基座210、多个支撑杆220、多个连接杆230以及调节杆240可以通过不同的连接方式相互连接以形成连杆结构。
其中，为保证所述支撑件200的具有足够的刚度以及所述连杆结构的稳定性，各部件优选采用不锈钢等金属材料制成。
具体地，请一并参阅图8至图10，本实施例中，所述支撑杆220的近端与所述第一基座210转动连接。所述第一基座210大致呈圆饼状，所述第一基座210的外周面上绕周向间隔开设多个第一连接槽211，每一所述第一连接槽211内对应容置一第一连接扣510，所述第一连接扣510转动连接所述第一基座210，每一所述支撑杆220的近端对应连接一所述第一连接扣510。
本实施例中，所述第一连接槽211为贯穿所述第一基座211两端面的U形槽，U形槽的开口朝向第一基座211的外侧周缘。所述第一连接扣510包括一圆环体511及连接于所述圆环体511的外周面上的扁平的一连接体513，所述连接体513上开设有穿装孔515。所述第一基座210的外周面上沿周向开设一圈与所述多个第一连接槽211均连通的第一环形槽213，所述第一环形槽213内嵌设第一环形箍215，所述第一环形箍215穿接于每一所述第一连接扣510的穿装孔515内，使得所述多个第一连接扣510均活动套设在所述第一环形箍215上，且所述第一连接扣510的连接体513容置于所述第一连接槽211内。其中， 所述第一连接槽211相对的两内壁面止挡于所述第一连接扣510的连接体513相对的两外壁面，使得所述第一连接扣510只能绕所述第一环形箍215上下转动，所述第一连接槽211贯通所述第一基座210的两端面为所述第一连接扣510的上下转动提供了活动空间。由此，每一所述支撑杆220可通过一所述第一连接扣510转动连接于所述第一基座210，多个支撑杆220能够以所述第一基座210为节点相对聚拢或者发散。
其中，所述支撑杆220的近端与所述第一连接扣510可以通过螺纹连接或者激光焊接进行固定连接，本实施例中，优选激光焊接。
其中，所述第一基座210的近端面上还设置有第一连接部260，所述第一连接部260用于与所述输送导管100的远端连接，以通过所述输送导管100输送所述支撑件200。
其中，所述第一基座210沿轴向开设有通孔，所述通孔与所述第一连接部260的内腔连通，以供所述调节杆240穿过。
进一步的，请一并参阅图10及图11，每一所述连接杆230的一端对应转动连接一第二连接扣520，每一所述第二连接扣520对应套设于一所述支撑杆520上，从而将一所述支撑杆220与一所述连接杆230转动连接。
具体地，本实施例中，所述第二连接扣520位于所述支撑杆220的近端与远端之间，所述第二连接扣520通过激光焊接或者压接的方式固定套设在所述支撑杆220上。
其中，需要说明的是，所述第二连接扣520与所述第一连接扣510的结构类似，不同之处在于，所述第二连接扣520的圆环体上固定连接有一对间隔的连接体，所述一对连接体之间形成一连接槽，所述连接杆230的一端的端部容置于所述连接槽内并通过一销钉与第二连接扣520转动连接。本实施例中，所述连接杆230为扁平的杆体，其两端均开设有连接孔231，且两端部均做圆滑处理。
进一步的，请一并参阅图8及图12，每一所述连接杆230的与转动连接对应的支撑杆220的一端相对的另一端与所述第二基座250转动连接。
如图12所示，本实施例中，所述第二基座250的结构与所述第一基座210的结构类似。具体地，所述第二基座250大致呈圆饼状，所述第二基座250的外周面上绕周向间隔开设多个U形的贯穿其两端面的第二连接槽252，所述第二基座250的外周面上沿周向开设一圈与所述多个第二连接槽252均连通的第二环形槽254，所述第二环形槽254内嵌设第二环形箍256，所述第二环形箍256穿接于每一所述连接杆230的连接孔231内，使得每一所述连接杆230的另一端均活动套设在所述第二环形箍256上，由此，每一所述连接杆230的另一端与所述第二基座250转动连接，多个连接杆230能够以所述第二基座250为节点相对聚拢或者发散。
其中，所述第二基座250的近端面沿轴向开设有连接孔，所述调节杆240的远端固定连接至所述连接孔内，固定连接方式包括但不限于螺纹连接、激光焊接，在此优选激光焊接。
需要说明的是，本申请中，所述第一环形箍215、所述第二环形箍256可以分别由一根金属丝在穿装所述多个第一连接扣510或所述多个连接杆230后，金属丝的两端通过焊接、压接或者套装于一连接套中的方式进行固定，从而形成一体的环形箍，所述金属丝包括但不限于不锈钢丝、镍钛金属丝等生物相容性的金属丝。当然，所述第一环形箍215、 所述第二环形箍256也可以采用高分子材料制成。
如上所述，所述第一基座210、所述多个支撑杆220、与所述多个支撑杆220对应转动连接的多个连接杆230、所述第二基座250及所述调节杆240即形成连杆结构，当驱动所述调节杆240沿轴向移动时，所述多个支撑杆220会被带动而呈现出相对于所述调节杆240的开合运动，当所述调节杆240的位置固定时(通过前述驱动控制件进行控制)，所述多个支撑杆220的开合角度也会固定形成锁定，从而能够实现对应设于每一所述支撑杆220远端的锚钉300的刚性支撑功能，以保证每一所述锚钉300能够准确、完整、牢靠地锚入瓣环组织的相应位置。
进一步的，本申请中，所述支撑件200还包括与所述多个支撑杆220对应设置的多个伸缩结构，一所述伸缩结构用于对应调整一所述锚钉300的近端与所述第一基座210之间的轴向距离(即沿所述调节杆240的轴向上的距离)。
具体地，请一并参阅图3、图13至图15，本实施例中，所述支撑杆220为中空杆体，其截面形状包括但不限于圆形、扁圆形、矩形、多边形等，优选采用圆形。所述支撑杆220的内腔中活动穿设锚钉控制杆310及固定连接于所述锚钉控制杆310远端的锚钉接头330，所述锚钉接头330与所述锚钉300可拆卸连接；所述锚钉控制杆310与所述锚钉接头330构成所述伸缩结构，所述锚钉300跟随所述锚钉控制杆310沿其轴向的移动以改变所述锚钉300的近端与所述第一基座210之间的轴向距离，所述锚钉300跟随所述锚钉控制杆310的旋转而旋转，以锚入瓣环组织。
其中，所述锚钉接头310的远端直径大于所述支撑杆220的内径，使得所述锚钉300位于所述支撑杆220的远端外。
其中，所述锚钉控制杆310可经由所述输送导管100的内腔延伸至患者体外并与操作手柄上相应的控制机构(图中未示)连接，从而通过所述控制机构即可控制所述锚钉控制杆310沿轴向移动以带动所述锚钉300自所述支撑杆220的远端伸出或者缩回。当所述支撑件200处于撑开状态时，通过所述控制机构可控制每一所述锚钉300相对于所述支撑杆220的远端伸出不同的距离，使得所述多个锚钉300锚入瓣环组织时，可适应瓣环组织的不同区域的凹凸情况，多个锚钉300锚定入瓣环组织的不同区域后，穿设于多个锚钉300近端上的所述柔性缩环件400并非处于一个平面，而是适应瓣环组织类似于马鞍形的真实的3D生理结构，以实现更好的缩环效果。
请再次参阅图1至图3，本申请提供的瓣环成形装置1000中，所述支撑件200连接于所述输送导管100的远端，以便于所述支撑件200处于收拢状态时，通过所述输送导管100推送所述支撑件200，且如前所述，所述支撑件200的调节杆240、所述锚钉控制杆310一并通过所述输送导管100的内腔延伸至体外。具体地，本实施例中，所述输送导管100为多腔导管，所述输送导管100包括沿轴向延伸的一主分腔及绕所述主分腔的周向间隔设置的若干副分腔。其中，所述主分腔用于供所述调节杆240穿过，每一所述副分腔用于供一所述锚钉控制杆穿过。
如图3所示，所述柔性缩环件400同时穿设于所述支撑件200远端的多个锚钉300近端上，在所述多个锚钉300锚入瓣环组织后，收紧所述柔性缩环件400即可收缩瓣环至合适程度。
其中，所述柔性缩环件400可以是闭环结构或者开环结构，优选地，所述柔性缩环件400采用闭环结构，闭环结构的所述柔性缩环件400经收紧后形成用于缩环的封闭环，收缩瓣环时受力更均匀，对瓣口的形状固定效果更佳。
其中，所述柔性缩环件400包括但不限于柔性线、柔性条或者柔性带，所述柔性条或者所述柔性带的截面形状包括但不限于扁圆形、矩形等。
请一并参阅图16及图17，本实施例提供的所述瓣环成形装置2000的使用过程如下：首先，在所述支撑件200的各支撑杆220相对聚拢、所述柔性缩环件400被收拢的初始状态下，所述输送导管100推动着所述支撑件100在鞘管1000建立的通道(图示以外鞘管经股静脉、下腔静脉、右心房、房间隔、左心房为例)内穿行，直至所述支撑件200穿出所述鞘管1000，使设置于所述支撑件200远端的所述多个锚钉300接近二尖瓣瓣环；然后，通过操控手柄的驱动控制件驱动所述调节杆240沿轴向移动以驱动各支撑杆220撑开呈伞状，接着通过操作手柄的控制机构逐个或者同时转动穿设于每一所述支撑杆220内的锚钉控制杆310转动，以带动每一所述锚钉300旋转，使得每一所述锚钉300锚入瓣环组织；最后，收紧穿设在多个锚钉300上的所述柔性缩环件400，完成缩环。
其中，在锚入每一锚钉300的过程中，还可以通过所述操作手柄的控制机构驱动每一所述锚钉控制杆310沿轴向移动，以改变每一所述锚钉300的近端与所述第一基座210之间的轴向距离，使得所述多个锚钉300锚入后，锚钉的近端处于不同的水平面上，进而使得穿设于所述多个锚钉300近端上的所述柔性缩环件400并非处于一个平面，有利于适应瓣环组织类似于马鞍形的真实的3D生理结构，实现更好的缩环效果。
本实施例提供的所述瓣环成形装置1000，在缩环的过程中，具有以下有益效果：1、所述支撑件200能够为多个锚钉300提供可靠地刚性支撑，使得所述多个锚钉300能够稳定地锚入瓣环组织；2、所述多个锚钉300同时被送至二尖瓣瓣环处，操作更加便捷；3、通过控制调节杆240沿轴向移动的距离，可以调节各支撑杆220被撑开的程度，使设置于各支撑杆220远端的多个锚钉300围成的圆环形的半径不同，能够适应不同个体的瓣环的生理解剖情况；4、采用闭环结构的所述柔性缩环件300经收紧后形成用于缩环的封闭环，比开环在收缩瓣环时受力更均匀，对瓣口的形状固定效果更佳；5、可伸缩结构的设置，能够使得多个锚钉300完成锚定后，穿设于它们近端上的柔性缩环件400能够适应瓣环组织类似于马鞍形的真实的3D生理结构，实现更好的缩环效果。
请一并参阅图18至图21，本申请第二实施例提供的瓣环成形装置的结构与第一实施例的瓣环成形装置1000的结构相似，不同之处在于：在第二实施例中，所述第一基座210b上绕周向间隔开设多个贯通所述第一基座210b的近端面与远端面的收容腔212，每一所述支撑杆220的近端活动穿设于一对应的所述收容腔212内，所述收容腔212包括近端限位段，所述近端限位段的轴线自近端向远端逐渐远离所述第一基座210b的轴线。
具体地，本实施例中，所述收容腔212的远端部分同时贯通所述第一基座210b的远端面和外周面的远端部分，使得所述收容腔212在远端具有较大的活动空间。当所述调节杆240(图中未示)沿轴向移动以驱使每一所述连接杆230(图中未示)将对应的支撑杆220撑开时，所述支撑杆220有沿所述第一基座210b的径向向外移动的趋势，所述支撑杆220的近端抵顶于所述近端限位段的内壁上，此时，若所述连接杆230进一步撑开所述支撑杆 220，所述支撑杆220的近端在所述近端限位段的止挡下不再沿径向移动，但所述支撑杆220远离近端的部分则在所述连接杆230的推动下继续向外移动，使得所述支撑杆220将以其近端为转动基点而相对于所述调节杆240张开，所述收容腔212的远端部分为所述支撑杆220的开合运动提供足够的空间，最终使所述支撑杆220相对于所述调节杆240张开至一定角度，多个支撑杆220张开成伞状，从而能够为所述多个支撑杆220远端的多个锚钉300提供支撑。
其中，所述第一基座210b沿轴向开设有供所述调节杆240穿过的通孔214。
可以理解的是，每一所述支撑杆220在连接杆及第二连接扣的限制下，所述支撑杆220不会从所述收容腔212中脱离。
本实施例中，每一所述支撑杆220的近端活动穿设于所述第一基座210b的收容腔212内，不需要第一实施例中的第一连接扣510及第一环形箍215，使得支撑件及整个瓣环成形装置的结构更加简单，便于安装。
请一并参阅图22至图24，本申请第三实施例提供的瓣环成形装置1000c的结构与第二实施例的瓣环成形装置的结构相似，不同之处在于：在第三实施例中，不设置锚钉控制杆及锚钉接头，锚钉300直接可拆卸连接于支撑杆220c的远端，所述支撑杆220c上设有沿其轴向延伸的外螺纹，所述第二连接扣520c内设置内螺纹，每一所述第二连接扣520c对应螺接套设于一所述支撑杆220c上，所述第二连接扣520c与所述支撑杆220c上的外螺纹构成所述伸缩结构。当所述支撑杆220c相对调节杆张开停止后，支撑杆220c旋转时，由于所述第二连接扣520c不会发生轴向移动，所述锚钉300跟随所述支撑杆220c的旋转同步旋转并会沿所述支撑杆220c的轴向移动，以改变所述锚钉300的近端与所述第一基座210c之间的轴向距离(即沿所述第一基座210c的轴向的距离)。
具体地，本实施例中，所述支撑杆220c为实心杆体，其远端设有插槽350，所述锚钉300的近端与所述插槽350插接，从而所述支撑杆220c的旋转可带动所述锚钉300旋转。
其中，所述第二连接扣520c螺接套设于所述支撑杆220c上，且所述第二连接扣520c还与对应的一连接杆230转动连接，当所述支撑杆220c旋转时，由于所述第二连接扣520c受到连接杆230的限位，因此，所述支撑杆220c可相对于所述第二连接扣520c沿其自身的轴向移动，进而带动远端的锚钉300沿支撑杆220c的轴向移动。
需要说明的是，所述支撑杆220c的近端活动穿设于所述第一基座210c的收容腔212内，且所述支撑杆220c的近端可经由输送导管100的副分腔连接至相应的控制机构(如蛇骨管等)，通过所述控制机构即可旋转所述支撑杆220c，且在所述控制机构的拉动下，所述支撑杆220c的近端不会自收容腔212内脱离出来。
可以理解的是，本实施例中，当各支撑杆220c被撑开成伞状时，通过所述控制机构控制不同的所述支撑杆220c相对于其对应螺接的第二连接扣520c旋转不同的圈数时，即可带动多个锚钉300发生不同程度的轴向伸缩，从而使得多个锚钉300锚入瓣环组织时，可适应瓣环组织的不同区域的凹凸情况，多个锚钉300锚定入瓣环组织的不同区域后，穿设于多个锚钉300近端上的柔性缩环件400并非处于一平面上，而是可以适应瓣环组织类似于马鞍形的真实的3D生理结构，可以实现更好的缩环效果。
在其他实施例中，结合参考图22、图23及图8，当所述第一基座210c的外周面上绕 周向间隔开设多个第一连接槽211，每一所述支撑杆220c的近端通过一第一连接扣转动连接于所述第一基座210c时，为避免所述第一连接扣阻碍所述支撑杆220c旋转，所述第一连接扣内对应设置内螺纹，每一所述支撑杆220c的近端对应螺接所述第一连接扣510c，从而通过所述控制机构带动所述支撑杆220c旋转时，所述支撑杆220c同时相对于所述第一连接扣和所述第二连接扣520c沿其自身的轴向移动，进而带动所述支撑杆220c远端的锚钉300沿支撑杆220c的轴向移动，同样可以改变每一所述锚钉300的近端与所述第一基座210c之间的轴向距离，以使得多个锚钉300锚入瓣环组织后，穿设于多个锚钉300近端上的柔性缩环件400并非处于一平面上，而是可以适应瓣环组织类似于马鞍形的真实的3D生理结构，以实现更好的缩环效果。
以上是本申请实施例的实施方式，应当指出，对于本技术领域的普通技术人员来说，在不脱离本申请实施例原理的前提下，还可以做出若干改进和润饰，这些改进和润饰也视为本申请的保护范围。

Claims (20)

  1. 一种支撑件，用于为多个锚钉锚入人体组织提供支撑，其特征在于，包括：
    第一基座；
    绕所述第一基座的周向间隔设置的多个支撑杆，每一所述支撑杆的近端于所述第一基座处相对聚拢，一所述锚钉对应设于一所述支撑杆的远端；
    与所述多个支撑杆对应设置的多个连接杆，一所述连接杆的一端对应转动连接一所述支撑杆；以及
    活动穿过所述第一基座的调节杆，所述调节杆与每一所述连接杆相对的另一端转动连接；
    所述调节杆沿轴向移动以驱使每一所述连接杆将对应的支撑杆撑开，所述多个支撑杆相对于所述调节杆张开成伞状。
  2. 如权利要求1所述的支撑件，其特征在于，还包括与所述多个支撑杆对应设置的多个伸缩结构，一所述伸缩结构用于对应调整一所述锚钉的近端与所述第一基座之间的轴向距离。
  3. 如权利要求2所述的支撑件，其特征在于，所述调节杆的远端固定连接第二基座，每一所述连接杆相对的另一端转动连接所述第二基座。
  4. 如权利要求3所述的支撑件，其特征在于，所述支撑杆相对于所述调节杆收拢时，所述第二基座与所述第一基座之间的轴向距离小于所述连接杆连接于对应的支撑杆的一端与所述第一基座之间的轴向距离。
  5. 如权利要求3所述的支撑件，其特征在于，所述支撑杆相对于所述调节杆收拢时，所述第二基座与所述第一基座之间的轴向距离大于所述连接杆连接于对应的支撑杆的一端与所述第一基座之间的轴向距离。
  6. 如权利要求3所述的支撑件，其特征在于，所述支撑杆的近端与所述第一基座转动连接。
  7. 如权利要求6所述的支撑件，其特征在于，所述第一基座的外周面上绕周向间隔开设多个第一连接槽，一所述第一连接槽内对应容置一第一连接扣，所述第一连接扣转动连接所述第一基座，一所述支撑杆的近端对应连接一所述第一连接扣。
  8. 如权利要求7所述的支撑件，其特征在于，所述第一基座的外周面上沿周向开设一圈与所述多个第一连接槽均连通的第一环形槽，所述第一环形槽内嵌设第一环形箍，所述多个第一连接扣均活动套设在所述第一环形箍上。
  9. 如权利要求3所述的支撑件，其特征在于，所述第一基座上绕周向间隔开设多个贯通所述第一基座的近端面与远端面的收容腔，一所述支撑杆的近端活动穿设于一对应的所述收容腔内；所述收容腔包括近端限位段，所述近端限位段的轴线自近端向远端逐渐远离所述第一基座的轴线。
  10. 如权利要求3所述的支撑件，其特征在于，所述第二基座的外周面上绕周向间隔开设多个第二连接槽，一所述连接杆的一端对应转动连接一第二连接扣，一所述第二连接扣对应套设于一所述支撑杆上，每一所述连接杆相对的另一端与所述第二基座转动连接。
  11. 如权利要求10所述的支撑件，其特征在于，所述第二基座的外周面上沿周向开设 一圈与所述多个第二连接槽均连通的第二环形槽，所述第二环形槽内嵌设第二环形箍，每一所述连接杆相对的另一端均活动套设在所述第二环形箍上。
  12. 如权利要求10所述的支撑件，其特征在于，所述第二连接扣位于所述支撑杆的近端与远端之间，所述第二连接扣固定套设在所述支撑杆上。
  13. 如权利要求2至12任一项所述的支撑件，其特征在于，所述支撑杆为中空杆体，所述支撑杆的内腔中活动穿设锚钉控制杆及固定连接于所述锚钉控制杆远端的锚钉接头，所述锚钉接头与所述锚钉可拆卸连接；所述锚钉控制杆与所述锚钉接头构成所述伸缩结构，所述锚钉跟随所述锚钉控制杆沿其轴向的移动以改变所述锚钉的近端与所述第一基座之间的轴向距离，所述锚钉跟随所述锚钉控制杆的旋转而旋转。
  14. 如权利要求10所述的支撑件，其特征在于，所述支撑杆上设有沿其轴向延伸的外螺纹，所述第一基座的外周面上绕周向间隔开设多个第一连接槽，一所述第一连接槽内对应容置一第一连接扣，所述第一连接扣转动连接所述第一基座，所述第一连接扣内设置内螺纹，一所述支撑杆的近端对应螺接一所述第一连接扣。
  15. 如权利要求10所述的支撑件，其特征在于，所述支撑杆上设有沿其轴向延伸的外螺纹，所述第一基座上绕周向间隔开设多个贯通所述第一基座的近端面与远端面的收容腔，一所述支撑杆的近端活动穿设于一对应的所述收容腔内；所述收容腔包括近端限位段，所述近端限位段的轴线自近端向远端逐渐远离所述第一基座的轴线。
  16. 如权利要求14或15所述的支撑件，其特征在于，所述第二连接扣内设置内螺纹，一所述第二连接扣对应螺接套设于一所述支撑杆上，所述第二连接扣与所述支撑杆上的外螺纹构成所述伸缩结构，所述锚钉跟随所述支撑杆的旋转同步旋转并沿所述支撑杆的轴向移动，以改变所述锚钉的近端与所述第一基座之间的轴向距离。
  17. 如权利要求16所述的支撑件，其特征在于，所述支撑杆的远端设有沿其轴向延伸的槽，所述锚钉的近端与所述槽插接，从而所述支撑杆的旋转带动所述锚钉旋转。
  18. 一种瓣环成形装置，其特征在于，包括如权利要求1至17任一项所述的支撑件、对应设于各所述支撑杆的远端的多个锚钉以及穿设于所述多个锚钉的近端上的柔性缩环件。
  19. 如权利要求18所述的瓣环成形装置，其特征在于，所述柔性缩环件为闭环结构或者开环结构。
  20. 如权利要求18所述的瓣环成形装置，其特征在于，还包括输送导管，所述第一基座固定连接于所述输送导管的远端，所述调节杆活动穿设于所述输送导管内。
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