WO2022242117A1 - 二尖瓣瓣环成形系统及其操作方法 - Google Patents

二尖瓣瓣环成形系统及其操作方法 Download PDF

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Publication number
WO2022242117A1
WO2022242117A1 PCT/CN2021/136127 CN2021136127W WO2022242117A1 WO 2022242117 A1 WO2022242117 A1 WO 2022242117A1 CN 2021136127 W CN2021136127 W CN 2021136127W WO 2022242117 A1 WO2022242117 A1 WO 2022242117A1
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mitral valve
locking
anchoring
outer tube
annuloplasty system
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PCT/CN2021/136127
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English (en)
French (fr)
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屠攀
徐军
林林
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上海汇禾医疗科技有限公司
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Publication of WO2022242117A1 publication Critical patent/WO2022242117A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus

Definitions

  • the embodiments of the present application relate to the technical field of medical devices, and in particular to a mitral valve annuloplasty system and a mitral valve annuloplasty method.
  • Mitral regurgitation is a valve malfunction that causes blood to flow from the left ventricle to the left atrium during systole (during which the left ventricle contracts) (in a healthy heart, this is prevented by the blocking action of the mitral valve.
  • the left ventricle flows to the left atrium) and causes an increase in left atrial pressure, while maintaining a normal cardiac output causes an increase in left ventricular pressure.
  • the present application provides a mitral valve annuloplasty system and an operation method thereof, so as to overcome the above problems or at least partly solve the above problems.
  • the first aspect of the present application provides a mitral valve annuloplasty system, which includes: an anchoring device, which can be connected to a wire body, and is used to anchor at least one target anchoring position on the posterior mitral valve in the left atrium, so that the thread body is positioned at the target anchoring position of the mitral valve posterior valve; an occlusion device, which can pass through the thread body, is used to block the position between the left atrium and the right atrium the interatrial septum; the locking device, which can pass through the thread body, is used to perform the locking operation of the thread body in the right atrium, and abut against the occlusion device adjacent to the right atrium a side for maintaining a predetermined distance between the posterior mitral valve and the anterior mitral valve in the left atrium; and a separation device for performing shearing of the thread body in the right atrium operate.
  • an anchoring device which can be connected to a wire body, and is used to anchor at least one target anchoring position on the posterior mitral valve in the left atrium,
  • the system includes a delivery sheath having a delivery channel that is sequentially accessible to the left atrium via the inferior vena cava, the right atrium, and the interatrial septum.
  • the anchoring device, the blocking device, the locking device, and the separating device are respectively movably inserted in the delivery channel of the delivery sheath, so that the delivery sheath can The tube reaches each target anchor site within the heart.
  • the second aspect of the present application provides an operation method of the mitral valve annuloplasty system, which is applied to the mitral valve annuloplasty system described in the above first aspect, which includes: providing the mitral valve annuloplasty system The delivery sheath enters the left atrium through the inferior vena cava, right atrium, and atrial septum of the heart in turn; provides the anchoring device connection line body of the mitral valve annuloplasty system, and enters the heart through the delivery sheath the left atrium of the left atrium to anchor at least one target anchoring position on the mitral valve posterior valve in the left atrium, so that the wire body is positioned on the target anchoring position of the mitral valve posterior valve; providing The occluding device of the mitral valve annuloplasty system passes through the thread body, and reaches the atrial septum of the heart through the delivery sheath, so as to occlude and position on the atrial septum; providing the locking device of the mitral valve annuloplasty system passing through the thread body, and reaching the right atrium of the heart through the delivery sheath
  • the mitral valve annuloplasty system and its operating method of the embodiment of the present application can realize the tightening of the mitral valve annulus by pulling, which can effectively solve the problem of mitral valve regurgitation, and has The treatment is simple and less invasive.
  • 1 to 7 show schematic views of different stages of mitral annuloplasty performed by a mitral annuloplasty system.
  • 8A to 9B, and 16A to 16C are schematic structural diagrams of anchoring devices according to different embodiments of the present application.
  • FIG. 10A to FIG. 10B show the schematic structural diagrams of the blocking device of the embodiment of the present application.
  • FIG. 11A to FIG. 11B are schematic structural diagrams of a locking device according to an embodiment of the present application.
  • Fig. 12A to Fig. 13B show the schematic structural diagrams of separation devices according to different embodiments of the present application.
  • Fig. 14A to Fig. 14B show the structural schematic diagrams of the thread body auxiliary operation instrument including the locking device and the separating device of the present application.
  • Fig. 15 shows a schematic diagram of the operation of conventional mitral valve annuloplasty.
  • 1 heart; 10: thread body; 11: inferior vena cava; 12: right atrium; 13: atrial septum; 14: left atrium; 141: posterior mitral valve; 142: anterior mitral valve; 2: anchoring device; 21: anchoring device; 211: anchoring member; 212: catheter; 213: connecting assembly; 2131: first connecting structure; 2132: second connecting structure; 22: anchoring device; 221: casing assembly; 2210 : directional channel; 2211: guide tube; 2212: guide piece; 222: anchor assembly; 2221: anchor hook; 2222: anchor seat; 23: anchor device; 231: mandrel; 232: anchor structure; 233 : sleeve shaft; 234: clamping structure; 3: blocking device; 31: first deformation body; 32: second deformation body; 33: blocking channel; 4: locking device; 41: first locking member; 42: second locking part; 43: conveying part; 44: auxiliary part; 5: separation device; 51: separation device; 511: outer tube; 5
  • the normal mitral valve leaflets have coaptation margins and normally close during systole to prevent blood flow from the left ventricle to the left atrium, whereas a diseased mitral valve annulus (eg, The enlarged mitral valve annulus) will not close normally during systole, resulting in blood regurgitation.
  • a diseased mitral valve annulus eg, The enlarged mitral valve annulus
  • a thoracotomy is mainly performed to implant an artificial valve ring 8 with a preset size into the heart 1 of the patient, and the diseased valve ring 81 is sutured on the artificial valve ring 8 to carry out valve ring tightening operation, so as to achieve the purpose of leaflet closure in systole, but the above-mentioned treatment method has the problem of relatively large invasiveness.
  • the embodiments of the present application provide a mitral valve annuloplasty system and an operating method thereof, which can overcome the above-mentioned technical problems.
  • the mitral valve annuloplasty system of the first embodiment of the present application is mainly used for mitral valve annuloplasty, which mainly includes anchoring device 2, blocking device 3, locking device 4 and separation device 5.
  • the mitral valve annuloplasty system further includes a delivery sheath 6 with a delivery channel 60, please refer to FIG. 1, the delivery sheath 6 can pass through the inferior vena cava 11 of the heart 1 in sequence , the right atrium 12, and the interatrial septum 13 enter the left atrium 14.
  • the anchoring device 2, the occluding device 3, the locking device 4 and the separating device 5 of the mitral valve annuloplasty system are respectively movably inserted in the delivery channel 60 of the delivery sheath 6, so as to use the delivery sheath
  • the tube 6 arrives at each target position in the heart 1 (for example, designated positions in the right atrium 12 , the interatrial septum 13 , and the left atrium 14 ).
  • the anchoring device 2 can be connected to the thread body 10 for anchoring at least one target anchoring position on the mitral valve posterior valve 141 in the left atrium 14, so that the thread body 10 is positioned behind the mitral valve The target anchoring position of the flap 141.
  • the anchoring device 2 can reach the left atrium 14 of the heart 1 through the delivery conduit 60 of the delivery sheath 6, and perform an anchoring operation on the target anchoring position on the posterior mitral valve 141, so that the wire body 10 Locate on target anchor position (refer to Figure 1).
  • the anchoring device 21 may include an anchoring member 211 , a catheter 212 and a connecting component 213 .
  • connection assembly 213 includes a first connection structure 2131 provided on the anchor 211 and a second connection structure 2132 provided on the catheter 212, the second connection structure 2132 is detachably combined with the first connection structure 2131 for
  • the catheter 212 and the anchor 211 are in a connected state or a disconnected state.
  • the anchor 211 can be controlled through the catheter 212 to target the target anchor on the posterior mitral valve 141.
  • the first connecting structure 2131 and the second connecting structure 2132 can be dissociated to place the second connecting structure 2132 and the catheter 212 are removed through the delivery sheath 6, leaving only the anchor 211 and the first connecting structure 2131 in the patient's body (refer to FIG. 8B ).
  • the anchoring device 22 may include a sleeve component 221 and an anchoring component 222.
  • the sleeve assembly 221 has at least one directional channel 2210 ; the anchor assembly 222 is movably threaded in the sleeve assembly 221 and has at least one anchor hook 2221 .
  • the anchor hook 2221 when the anchor hook 2221 is located in the sleeve assembly 221, it is in an unanchored state.
  • the anchor hook 2221 can be released from the sleeve assembly through the directional channel 2210. 221 stretches out and directs the bending deformation to switch from the non-anchored state to the anchored state, and then performs the anchoring operation on the target anchoring position on the mitral valve posterior valve 141 to position the wire body 10 at the target anchoring position.
  • part of the auxiliary parts on the anchoring device 22 can be removed, and only the guide tube 2211 of the sleeve assembly 221, the guide piece 2212, and the guide tube 2211 are passed through and mounted.
  • the anchor hook 2221 and the anchor seat 2222 on the guide 2212 are left in the patient's body (refer to FIG. 9B ).
  • the anchoring device 23 may include a core shaft 231 , an anchoring structure 232 , a sleeve shaft 233 , and a clamping structure 234 .
  • the anchoring structure 232 is connected to the core shaft 231
  • the sleeve shaft 233 is movably sleeved on the core shaft 231
  • the clamping structure 234 is connected to the sleeve shaft 233 .
  • the anchoring structure 232 can be used to anchor the target tissue
  • the mandrel 231 can move axially relative to the sleeve shaft 233 to drive the anchoring structure 232 to move from the non-clamping position to the clamping position
  • the clamping structure 234 can be released from the release state Switch to the clamping state to clamp the target tissue anchored on the anchoring structure 232 .
  • the anchoring structure 232 can be in the clamping position and the clamping structure 234 can be in the clamping state, and the anchoring device 23 can be delivered to the target tissue to be anchored (such as the heart) by a delivery system (not shown). Near the valve annulus), then, the clamping structure 234 is switched from the clamping state to the release state, so that the anchoring structure 232 can perform the anchoring operation on the target tissue (refer to the state shown in FIG.
  • the anchoring structure 232 can anchor After the target tissue is determined, the anchoring structure 232 can be moved from the non-clamping position to the clamping position relative to the clamping structure 234 by axially moving the mandrel 231 relative to the sleeve shaft 233, so that the anchoring structure 232 Pull the target tissue between the two clamping arms of the clamping structure 234 (refer to the state shown in FIG. 16B ), and then switch the clamping structure 234 from the release state to the clamping state, so as to clamp the anchor on the anchor Target tissue on structure 232 (see state shown in FIG. 16C).
  • the occluding device 3 can pass through the thread body 10, and is used to occlude the interatrial septum 13 between the left atrium 14 and the right atrium 12 (refer to Fig. 1 and Fig. 2 ).
  • the blocking device 3 can be a first deformable body 31, a second deformable body 32, and a blocking channel 33 for passing through the thread body 11.
  • the occlusion device 3 can be entirely stored in the delivery channel 60 of the delivery sheath 6 for delivery (refer to FIG. 10A ).
  • the first deformable body 31 can be expanded and deformed and abutted against the side of the interatrial septum 13 close to the left atrium 14 (refer to the state shown in Figure 1), and then the second deformable body can be made 32 is expanded and deformed to abut against the side of the interatrial septum 13 close to the right atrium 12, so that the interatrial septum 13 of the heart 1 is sandwiched between the first deformable body 31 and the second deformable body 32 (refer to FIG. 2 and FIG. 10B ) display status).
  • the locking device 4 can pass through the thread body 10 for performing the locking operation of the thread body 10 in the right atrium 12, and abuts against the side of the occlusion device 3 adjacent to the right atrium 12, so that the two sides in the left atrium 14
  • the posterior mitral valve 141 and the mitral anterior valve 142 maintain a preset distance.
  • the locking device 4 can reach the right atrium 12 of the heart 1 through the delivery conduit 60 of the delivery sheath 6, so as to perform a locking operation on the thread body 10 and abut against the occlusion device 3 (refer to FIG. 3 ). .
  • the locking device 4 may include a first locking member 41, a second locking member 42, a conveying member 43 and an auxiliary member 44; wherein, the first locking member 41 can be axially locked or disengaged from the second locking member 42 and the conveying member 43 respectively; the auxiliary member 44 is detachably connected to the second locking member 42 and is used to assist the second locking member 42 Positioning: at least one of the first locking piece 41 and the second locking piece 42 is used to pass through the wire body 10, and is locked by axially locking the first locking piece 41 and the second locking piece 42 The thread body 10 also abuts against the blocking device 3 .
  • the distance between the anchoring device 2 and the occlusion device 3 can be adjusted by pulling the thread body 10 on the side of the occlusion device 3 located at the right atrium 12, so that the mitral valve in the left atrium 14
  • the valve 141 and the anterior mitral valve 142 maintain a predetermined separation distance (that is, the mitral valve posterior valve 141 and the mitral valve anterior valve 142 can be closed during systole to prevent regurgitation), and after the adjustment is completed,
  • Use the locking device 4 that is, the first locking member 41 and the second locking member 42) to perform a locking operation on the thread body 10 and abut against the side of the occluding device 3 adjacent to the right atrium 12 (refer to the state shown in FIG. 3 ).
  • the delivery part 43 and the auxiliary part 44 of the locking device 4 can be disengaged from the first locking part 41 and the second locking part 42 respectively and removed via the delivery sheath 6 , and only the first locking member 41 and the second locking member 42 are left in the patient's body.
  • the separating device 5 is used to perform a cutting operation on the thread body 10 in the right atrium 12 .
  • the separating device 5 can reach the right atrium 12 of the heart 1 through the delivery tube 60 of the delivery sheath 6 , and perform a cutting operation on the locked thread body 10 (refer to FIGS. 4 to 5 ).
  • the separation device 51 includes an outer tube 511 and a core tube 512, wherein the outer tube 511 includes an outer tube channel 5110 and a threading structure 5112, and the outer tube channel 5110 axially passes through the outer tube.
  • Tube 511, the threading structure 5112 is arranged on the outer tube distal end 5114 of the outer tube 511 and is used for threading the thread body 10; Shear structure 5122 of distal end 5120.
  • the core tube 512 can move axially toward the distal end 51147 of the outer tube relative to the outer tube 511, so that the shearing structure 5122 cuts off the thread body 10 passing through the threading structure 5112 (refer to the state shown in FIG. 12B ).
  • the separating device 52 may include an outer tube 521 , a core tube 522 and a shearing component 523 .
  • the outer tube 521 is used for positioning the wire body 10; the core tube 522 can be movably penetrated in the outer tube 521; the shear assembly 523 is respectively connected to the outer tube 521 and the core tube 522; and wherein, the core tube 522 can be 521 reciprocates in the axial direction, and drives the shearing assembly 523 to switch between the non-active state and the active state, so as to shear the thread body 10 positioned on the outer tube 521 .
  • the locking device and the separating device can also be combined to form the thread body auxiliary operation device 7 (refer to FIG. 14A and FIG. 14B ).
  • the locking device 71 in the thread body auxiliary operation instrument 7 can pass through the thread body 10 therein, and has a locking structure 711 and a locking control structure 712, and the locking control structure 712 can be locked relative to the locking structure 711
  • the reciprocating movement is used to provide the thread body 10 to move relative to the locking structure 711 or to control the locking structure 711 to lock the thread body 10 and abut against the blocking device 3 .
  • the separating device 72 can be threaded by the thread body 10 therein, and has a shearing structure 721 and a shearing control structure 722.
  • the shearing control structure 722 can move relative to the shearing structure 721 to control the shearing structure 721 to cut the thread. body 10, and after the shearing operation is completed, the whole of the separating device 72 can be withdrawn through the delivery sheath 6.
  • anchoring device 2 the blocking device 3, the locking device 4, and the separating device 5 in the above-mentioned embodiments are not used for limiting purposes, that is, any The anchoring device 2 , the blocking device 3 , the locking device 4 , and the separating device 5 for the interventional operation performed are all applicable to this application.
  • the second embodiment of the present application provides an operating method of the mitral valve annuloplasty system, which is applied to the mitral valve annuloplasty system described in the first embodiment above, which mainly includes the following operation steps:
  • Step 1 providing the delivery sheath 6 of the mitral valve annuloplasty system into the left atrium 14 through the inferior vena cava 11, right atrium 12, and interatrial septum 13 of the heart 1 (refer to FIG. 1 ).
  • Step 2 provide the anchoring device 2 of the mitral valve annuloplasty system to connect the wire body 10, and enter the left atrium 14 of the heart 1 through the delivery sheath 6, so as to anchor the posterior mitral valve 141 in the left atrium 14 At least one target anchoring position, so that the wire body 10 is positioned on the target anchoring position of the mitral valve posterior valve 141 (refer to FIG. 1 ).
  • Step 3 provide the occlusion device 3 of the mitral valve annuloplasty system through the thread body 10, and reach the interatrial septum 13 of the heart through the delivery sheath 6, so as to occlude and locate the interatrial septum 13 of the heart 1 on (refer to Figure 2).
  • Step 4 provide the locking device 4 of the mitral valve annuloplasty system through the thread body 10, and reach the right atrium 12 of the heart 1 through the delivery sheath 6, so as to adjust the relative position of the thread body 10 in the right atrium 12.
  • the locking device 4 is provided to perform a locking operation on the thread body 10 and Abut on the occlusion device 3, so that the mitral valve posterior valve 141 and the mitral valve anterior valve 142 maintain a preset distance, that is, the mitral valve posterior valve 141 and the mitral valve anterior valve 142 are in the systolic phase Can be closed to prevent reflux (see Figure 3).
  • Step 5 provide the separation device 5 of the mitral valve annuloplasty system through the thread body 10, and reach the right atrium 12 of the heart 1 through the delivery sheath 6, so as to perform shearing on the thread body 10 in the right atrium 12 cut operation (refer to Figure 4 to Figure 7).
  • the mitral valve annuloplasty system and its operating method provided by the embodiment of the present application can realize the tightening of the mitral valve annulus by pulling, which is not only easier to operate, but also can effectively solve the problem of The problem with mitral valve regurgitation.
  • this application has less invasiveness, which is beneficial to the postoperative recovery of patients.

Abstract

一种二尖瓣瓣环成形系统及其操作方法，其中二尖瓣瓣环成形系统主要包括锚定装置（2，21，22，23）、封堵装置（3）、锁紧装置（4）和分离装置（5，51，52），其中，锚定装置（2，21，22，23）针对二尖瓣后瓣（141）执行锚定以使线体（10）定位于二尖瓣后瓣（141）上，封堵装置（3）用于封堵位于左心房（14）和右心房（12）之间的房间隔（13），锁紧装置（4）用于在右心房（12）执行线体（10）的定位以及锁紧操作，并抵接于封堵装置（3）位于右心房（12）的一侧，以使左心房（14）内的二尖瓣后瓣（141）与二尖瓣前瓣（142）维持预设间距；分离装置（5，51，52）用于针对右心房（12）内的线体（10）执行剪切操作。借此，提供了一种侵入性更小的二尖瓣瓣环成形技术。

Description

二尖瓣瓣环成形系统及其操作方法
本申请要求在2021年5月17日提交中国专利局、申请号为202110535550.3、发明名称为“二尖瓣瓣环成形系统及其操作方法”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请实施例涉及医疗器械技术领域，尤其涉及一种二尖瓣瓣环成形系统及二尖瓣瓣环成形方法。
背景技术
二尖瓣关闭不全是一种瓣膜功能障碍，其可导致血液在收缩期(左心室收缩期间)从左心室流向左心房(在健康的心脏中，可借由二尖瓣的阻隔作用而防止由左心室流向左心房)，并会导致左心房的压力升高，而维持正常的心输出量会导致左心室压力升高。
目前，针对患有MR(二尖瓣关闭不全)或TR(三尖瓣关闭不全)的患者进行治疗可能需要更换瓣膜，以减少或消除返流。近年来，普遍接受的治疗方法是在心脏直视手术期间进行外科手术修复或更换天然瓣膜。
有鉴于此，亟需一种可用于治疗二尖瓣功能性返流且侵入性较小的医疗产品。
发明内容
鉴于上述问题，本申请提供一种二尖瓣瓣环成形系统及其操作方法，以克服上述问题或者至少部分地解决上述问题。
本申请第一方面提供一种二尖瓣瓣环成形系统，其包括：锚定装置，其可连接线体，用于锚定左心房内二尖瓣后瓣上的至少一个目标锚定位置，以使所述线体定位于所述二尖瓣后瓣的所述目标锚定位置上；封堵装置，其可 穿设所述线体，用于封堵位于所述左心房和右心房之间的房间隔；锁紧装置，其可穿设所述线体，用于在所述右心房执行所述线体的锁紧操作，并抵接于所述封堵装置邻接所述右心房的一侧，以使所述左心房内的所述二尖瓣后瓣与二尖瓣前瓣维持预设间距；以及分离装置，其用于在所述右心房内针对所述线体执行剪切操作。
可选地，所述系统包括具有输送通道的输送鞘管，其可依次经由下腔静脉、所述右心房、所述房间隔进入所述左心房。
可选地，所述锚定装置、所述封堵装置、所述锁紧装置、所述分离装置分别可活动地穿设于所述输送鞘管的输送通道内，以借由所述输送鞘管抵达心脏内的各目标锚定位置。
本申请第二方面提供一种二尖瓣瓣环成形系统的操作方法，应用于上述第一方面所述的二尖瓣瓣环成形系统，其包括：提供所述二尖瓣瓣环成形系统的输送鞘管依次经由心脏的下腔静脉、右心房、房间隔进入左心房；提供所述二尖瓣瓣环成形系统的锚定装置连接线体，并借由所述输送鞘管进入所述心脏的左心房，以锚定所述左心房内二尖瓣后瓣上的至少一目标锚定位置，使得所述线体定位于所述二尖瓣后瓣的所述目标锚定位置上；提供所述二尖瓣瓣环成形系统的封堵装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的房间隔，以封堵并定位于所述房间隔上；提供所述二尖瓣瓣环成形系统的锁紧装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的右心房，以在所述右心房内调整所述线体相对于所述锁紧装置的定位位置，直至所述左心房内的所述二尖瓣后瓣与二尖瓣前瓣满足预设间隔距离，再提供所述锁紧装置针对所述线体执行锁紧操作并抵接于所述封堵装置上，使得所述二尖瓣后瓣与所述二尖瓣前瓣之间维持所述预设间隔距离；提供所述二尖瓣瓣环成形系统的分离装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的右心房，以针对所述右心房内的所述线体执行剪切操作。
由以上技术方案可见，本申请实施例的二尖瓣瓣环成形系统及其操作方法通过牵拉方式实现二尖瓣瓣环的束紧成形，可有效解决二尖瓣反流的问题， 并具有治疗操作简便且侵入性小的优点。
附图说明
为了更清楚地说明本申请实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本申请实施例中记载的一些实施例，对于本领域普通技术人员来讲，还可以根据这些附图获得其他的附图。
图1至图7示出了借由二尖瓣瓣环成形系统执行二尖瓣瓣环成形术的不同阶段的示意图。
图8A至图9B、图16A至图16C示出了本申请不同实施例的锚定装置的结构示意图。
图10A至图10B示出了本申请实施例的封堵装置的结构示意图。
图11A至图11B示出了本申请实施例的锁紧装置的结构示意图。
图12A至图13B示出了本申请不同实施例的分离装置的结构示意图。
图14A至图14B示出了本申请包括锁紧装置和分离装置的线体辅助操作器械的结构示意图。
图15示出了传统二尖瓣瓣环成形术的操作示意图。
元件标号
1：心脏；10：线体；11：下腔静脉；12：右心房；13：房间隔；14：左心房；141：二尖瓣后瓣；142：二尖瓣前瓣；2：锚定装置；21：锚定装置；211：锚定件；212：导管；213：连接组件；2131：第一连接结构；2132：第二连接结构；22：锚定装置；221：套管组件；2210：定向通道；2211：导向管；2212：导向件；222：锚定组件；2221：锚定勾；2222：锚定座；23：锚定装置；231：芯轴；232：锚定结构；233：套轴；234：夹持结构；3：封堵装置；31：第一变形体；32：第二变形体；33：封堵通道；4：锁紧装置；41：第一锁紧件；42：第二锁紧件；43：输送件；44：辅助件；5：分离装置；51： 分离装置；511：外管；5110：外管通道；5112：穿线结构；5114：外管远端；512：芯管；5120：芯管远端；5122：剪切结构；52：分离装置；521：外管；522：芯管；523：剪切组件；6：输送鞘管；60：输送通道；7：线体辅助操作器械；71：锁紧装置；711：锁紧结构；712：锁紧控制结构；72：分离装置；721：剪切结构；722：剪切控制结构；8：人工瓣环(现有技术)；81：瓣环。
具体实施方式
为了使本领域的人员更好地理解本申请实施例中的技术方案，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，所描述的实施例仅是本申请实施例一部分实施例，而不是全部的实施例。基于本申请实施例中的实施例，本领域普通技术人员所获得的所有其他实施例，都应当属于本申请实施例保护的范围。
呈上在背景技术部分所述，正常的二尖瓣瓣叶具有对合缘，并可在收缩期正常闭合，以防止血液从左心室流向左心房，而存在病变的二尖瓣瓣环(例如扩大的二尖瓣瓣环)的对合缘会在收缩期无法正常闭合，从而造成血液反流的现象。
请配合参考图15，目前针对二尖瓣关闭不全的瓣膜功能障碍，主要通过开胸手术，以将具有预设大小的人工瓣环8植入患者心脏1内，并通过将产生病变的瓣环81缝合在人工瓣环8上以进行瓣环束紧操作，从而达到收缩期瓣叶闭合的目的，上述治疗方式存在着侵入性较大的问题。有鉴于此，本申请实施例提供一种二尖瓣瓣环成形系统及其操作方法，可以克服上述技术问题。
下面将结合本申请实施例附图进一步说明本申请实施例具体实现。
第一实施例
请结合参考图1至图7，本申请第一实施例的二尖瓣瓣环成形系统主要用于执行二尖瓣瓣环成形术，其主要包括锚定装置2、封堵装置3、锁紧装置 4和分离装置5。
可选地，二尖瓣瓣环成形系统还包括具有输送通道60的输送鞘管6，请配合参考图1，输送鞘管6可依次经由心脏1的下腔静脉11可依次经由下腔静脉11、右心房12、房间隔13进入左心房14。
其中，二尖瓣瓣环成形系统的锚定装置2、封堵装置3、锁紧装置4和分离装置5分别可活动地穿设于输送鞘管6的输送通道60内，以借由输送鞘管6抵达心脏1内的各目标位置(例如右心房12、房间隔13、左心房14中的指定位置)。
于本实施例中，锚定装置2可连接线体10，用于锚定左心房14内二尖瓣后瓣141上的至少一个目标锚定位置，以使线体10定位于二尖瓣后瓣141的目标锚定位置上。
可选地，二尖瓣后瓣141上的目标锚定位置可为一个(参考图1至图6)或两个(参考图7)，亦可为两个以上，视依实际需求进行调整。
具体而言，锚定装置2可经由输送鞘管6的输送管道60抵达心脏1的左心房14，并针对二尖瓣后瓣141上的目标锚定位置执行锚定操作，以将线体10定位在目标锚定位置上(参考图1)。
请配合参考图8A和图8B，于一实施例中，锚定装置21可包括锚定件211、导管212和连接组件213。
具体地，连接组件213包括设于锚定件211上的第一连接结构2131以及设于导管212上的第二连接结构2132，第二连接结构2132可拆卸地结合第一连接结构2131，以供导管212与锚定件211之间处于连接状态或解离状态，当导管212与锚定件211呈连接状态时，可经由导管212控制锚定件211针对二尖瓣后瓣141上的目标锚定位置执行锚定操作，以将线体10定位于目标锚定位置上，并在完成锚定操作后，可通过解离第一连接结构2131和第二连接结构2132，以将第二连接结构2132与导管212经由输送鞘管6撤除，而仅留锚定件211和第一连接结构2131于患者体内(参考图8B)。
请结合参考图9A和图9B，于另一实施例中，锚定装置22可包括套管组 件221和锚定组件222。
具体地，套管组件221具有至少一个定向通道2210；锚定组件222可活动地穿设在套管组件221中并具有至少一个锚定勾2221。其中，当锚定勾2221位于套管组件221中时处于非锚定状态，当锚定组件222相对于套管组件221轴向移动时，可使得锚定勾2221经由定向通道2210自套管组件221中伸出并定向弯曲形变，以由非锚定状态切换至锚定状态，进而针对二尖瓣后瓣141上的目标锚定位置执行锚定操作，以将线体10定位于目标锚定位置上,且在完成锚定操作后，可撤除锚定装置22上的部分辅助零部件，而仅将套管组件221的导向管2211、导向件2212以及穿设在导向管2211中并骑设在导向件2212上的锚定勾2221、锚定座2222留置于患者体内(参考图9B)。
请结合参考图9A和图9B，于另一实施例中，锚定装置23可包括芯轴231、锚定结构232、套轴233、夹持结构234。
于本实施例中，锚定结构232连接芯轴231，套轴233可活动地套接于芯轴231上，夹持结构234连接套轴233。
其中，锚定结构232可用于锚定目标组织，芯轴231可相对于套轴233轴向移动以带动锚定结构232由非夹持位置移动至夹持位置，且夹持结构234可由释放状态切换至夹持状态，以夹持锚定于锚定结构232上的目标组织。
具体地，可令锚定结构232处于夹持位置且令夹持结构234处于夹持状态，并借由输送系统(未示出)将锚定器械23输送至待锚定的目标组织(例如心脏瓣环)附近，接着，令夹持结构234由夹持状态切换至释放状态，以供锚定结构232针对目标组织执行锚定操作(参考图16A所示状态)，并在锚定结构232锚定目标组织之后，可通过令芯轴231相对于套轴233轴向移动，以使锚定结构232相对于夹持结构234由非夹持位置移动至夹持位置，以借由锚定结构232将目标组织提拉至夹持结构234的两个夹持臂之间(参考图16B所示状态)，再令夹持结构234由释放状态切换至夹持状态，以夹持锚定于锚定结构232上的目标组织(参考图16C所示状态)。
封堵装置3可穿设线体10，并用于封堵位于左心房14和右心房12之间 的房间隔13(参考图1和图2)。
请配合参考图10A和图10B，于一实施例中，封堵装置3可第一变形体31、第二变形体32以及用于穿设线体11的封堵通道33，其中，当第一变形体31和第二变形体32处于收缩状态时，封堵装置3可整体收纳于输送鞘管6的输送通道60内进行输送(参考图10A)，当封堵装置3被输送至心脏3内房间隔13靠近左心房14的一侧时，可令第一变形体31产生扩张变形并抵接于房间隔13靠近左心房14的一侧(参考图1所示状态)，再令第二变形体32产生扩张变形以抵接于房间隔13靠近右心房12的一侧，使得心脏1的房间隔13夹设在第一变形体31和第二变形体32之间(参考图2、图10B所示状态)。
锁紧装置4可穿设线体10，用于在右心房12执行线体10的锁紧操作，并抵接于封堵装置3邻接右心房12的一侧，以使左心房14内的二尖瓣后瓣141与二尖瓣前瓣142维持预设间距。
具体而言，锁紧装置4可经由输送鞘管6的输送管道60抵达心脏1的右心房12中，以针对线体10执行锁紧操作并抵接在封堵装置3上(参考图3)。
请配合参考图11A和图11B，于一实施例中，锁紧装置4可包括第一锁紧件41、第二锁紧件42、输送件43和辅助件44；其中，第一锁紧件41分别与第二锁紧件42和输送件43可轴向锁紧或解离；辅助件44与第二锁紧件42可拆卸地连接，且用于辅助第二锁紧件42沿轴向定位；第一锁紧件41与第二锁紧件42之至少其中一者用于穿设线体10，并通过轴向锁紧第一锁紧件41与第二锁紧件42而锁紧线体10并抵接于封堵装置3上。
具体地，可通过在封堵装置3位于右心房12的一侧牵拉线体10，以调整锚定装置2和封堵装置3之间的间隔距离，使得左心房14内的二尖瓣后瓣141与二尖瓣前瓣142之间维持预设间隔距离(亦即，二尖瓣后瓣141与二尖瓣前瓣142在收缩期可闭合以防止反流)，并在调整完成后，利用锁紧装置4(即第一锁紧件41与第二锁紧件42)针对线体10执行锁紧操作并抵接封堵装置3邻接右心房12的一侧(参考图3所示状态)。
此外，在完成线体10的锁紧操作之后，锁紧装置4的输送件43和辅助件44可分别与第一锁紧件41和第二锁紧件42解离并经由输送鞘管6撤除，而仅将第一锁紧件41和第二锁紧件42留置于患者体内。
分离装置5用于在右心房12内针对线体10执行剪切操作。
具体而言，分离装置5可经由输送鞘管6的输送管道60抵达心脏1的右心房12，并针对完成锁紧后的线体10执行剪切操作(参考图4至图5)。
请配合参考图12A和图12B，于一实施例中，分离装置51包括外管511和芯管512，其中，外管511包括外管通道5110和穿线结构5112，外管通道5110轴向贯穿外管511，穿线结构5112设于外管511的外管远端5114并用于穿设线体10；芯管512可活动地穿设于外管通道5110中，并包括设于芯管512的芯管远端5120的剪切结构5122。
其中，芯管512可相对于外管511朝外管远端51147的方向轴向移动，以使剪切结构5122切断穿设于穿线结构5112中的线体10(参考图12B所示状态)。
请配合参考图13A和图13B，于另一实施例中，分离装置52可包括外管521、芯管522和剪切组件523。其中，外管521用于定位线体10；芯管522可活动地穿设于外管521内；剪切组件523分别连接外管521和芯管522；且其中，芯管522可沿外管521的轴向往复移动，并带动剪切组件523在非作用状态与作用状态之间切换，以剪切定位于外管521上的线体10。
于又一实施例中，也可组合锁紧装置和分离装置以构成线体辅助操作器械7(参考图14A和图14B)。
具体地，线体辅助操作器械7中的锁紧装置71可供线体10穿设于其中，并具有锁紧结构711和锁紧控制结构712，锁紧控制结构712可相对于锁紧结构711往复移动，以提供线体10相对于锁紧结构711移动或者控制锁紧结构711锁紧线体10并抵接于封堵装置3上。再者，分离装置72可供线体10穿设于其中，并具有剪切结构721和剪切控制结构722，剪切控制结构722可相对于剪切结构721移动以控制剪切结构721剪断线体10,且在完成剪切 操作后，分离装置72整体可经由输送鞘管6撤离。
需说明的是，上述各实施例的锚定装置2、封堵装置3、锁紧装置4、分离装置5并非用于限制的目的，亦即，任何可经由导管(即输送鞘管6)所执行的介入类手术操作的锚定装置2、封堵装置3、锁紧装置4、分离装置5均可适用于本申请。
第二实施例
本申请第二实施例提供一种二尖瓣瓣环成形系统的操作方法，应用于上述第一实施例所述的二尖瓣瓣环成形系统，其主要包括以下操作步骤：
步骤1，提供二尖瓣瓣环成形系统的输送鞘管6依次经由心脏1的下腔静脉11、右心房12、房间隔13进入左心房14(参考图1)。
步骤2,提供二尖瓣瓣环成形系统的锚定装置2连接线体10，并借由输送鞘管6进入心脏1的左心房14，以锚定左心房14内二尖瓣后瓣141上的至少一目标锚定位置，使得线体10定位于二尖瓣后瓣141的目标锚定位置上(参考图1)。
步骤3,提供二尖瓣瓣环成形系统的封堵装置3穿设线体10于其中，并借由输送鞘管6抵达心脏的房间隔13，以封堵并定位于心脏1的房间隔13上(参考图2)。
步骤4，提供二尖瓣瓣环成形系统的锁紧装置4穿设线体10于其中，并借由输送鞘管6抵达心脏1的右心房12，以在右心房12内调整线体10相对于锁紧装置4的定位位置，直至左心房14内的二尖瓣后瓣141与二尖瓣前瓣142满足预设间隔距离，而后，提供锁紧装置4针对线体10执行锁紧操作并抵接于封堵装置3上，使得二尖瓣后瓣141与二尖瓣前瓣142之间维持预设间隔距离，亦即，二尖瓣后瓣141与二尖瓣前瓣142在收缩期可闭合以防止反流(参考图3)。
步骤5，提供二尖瓣瓣环成形系统的分离装置5穿设线体10于其中，并借由输送鞘管6抵达心脏1的右心房12，以针对右心房12内的线体10执行剪切操作(参考图4至图7)。
综上所述，本申请实施例提供的二尖瓣瓣环成形系统及其操作方法通过牵拉方式即可实现心脏二尖瓣瓣环的束紧成形，不仅操作更为简便，且可有效解决二尖瓣反流的问题。
此外，相较于传统心脏二尖瓣瓣环成形术，本申请具有更小的侵入性，利于患者的术后恢复。
最后应说明的是：以上实施例仅用以说明本申请实施例的技术方案，而非对其限制；尽管参照前述实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的精神和范围。

Claims (12)

  1. 一种二尖瓣瓣环成形系统，其特征在于，包括：
    锚定装置，其可连接线体，用于锚定左心房内二尖瓣后瓣上的至少一个目标锚定位置，以使所述线体定位于所述二尖瓣后瓣的所述目标锚定位置上；
    封堵装置，其可穿设所述线体，用于封堵位于所述左心房和右心房之间的房间隔；以及
    锁紧装置，其可穿设所述线体，用于在所述右心房执行所述线体的锁紧操作，并抵接于所述封堵装置邻接所述右心房的一侧，以使所述左心房内的所述二尖瓣后瓣与二尖瓣前瓣维持预设间距；
    分离装置，其用于在所述右心房内针对所述线体执行剪切操作。
  2. 根据权利要求1所述的二尖瓣瓣环成形系统，其特征在于，所述线体包括由医用高分子材料或金属材料制成的线或丝。
  3. 根据权利要求1所述的二尖瓣瓣环成形系统，其特征在于，所述系统包括具有输送通道的输送鞘管，其可依次经由下腔静脉、所述右心房、所述房间隔进入所述左心房。
  4. 根据权利要求3所述的二尖瓣瓣环成形系统，其特征在于，所述锚定装置、所述封堵装置、所述锁紧装置、所述分离装置分别可活动地穿设于所述输送鞘管的输送通道内，以借由所述输送鞘管抵达心脏内的各目标锚定位置。
  5. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述锚定装置包括锚定件、导管、和连接组件；其中
    所述连接组件包括设于所述锚定件上的第一连接结构以及设于所述 导管上的第二连接结构，所述第二连接结构可拆卸地结合至所述第一连接结构，以供所述导管与所述锚定件之间处于连接状态或解离状态。
  6. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述锚定装置包括套管组件和锚定组件；
    其中，所述套管组件具有至少一个定向通道；所述锚定组件可活动地穿设在所述套管组件中并具有至少一个锚定勾；
    且其中，当所述锚定勾位于所述套管组件中时处于非锚定状态，所述锚定组件可相对于所述套管组件轴向移动，使得所述锚定勾经由所述定向通道自所述套管组件中伸出并定向弯曲形变，以由所述非锚定状态切换至锚定状态。
  7. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述锚定装置包括芯轴、锚定结构、套轴、夹持结构；
    所述锚定结构连接所述芯轴，所述套轴可活动地套接于所述芯轴上，所述夹持结构连接所述套轴；
    其中，所述锚定结构可用于锚定目标组织，所述芯轴可相对于所述套轴轴向移动以带动所述锚定结构由非夹持位置移动至夹持位置，且所述夹持结构可由释放状态切换至夹持状态，以夹持锚定于所述锚定结构上的所述目标组织。
  8. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述系统还包括线体辅助操作器械，其包括所述锁紧装置和所述分离装置，其中，
    所述锁紧装置可供所述线体穿设于其中，并具有锁紧结构和锁紧控制结构，所述锁紧控制结构可相对于所述锁紧结构往复移动，以提供所述线体相对于所述锁紧结构移动或者控制所述锁紧结构锁紧所述线体并抵接于所述封堵装置上；
    所述分离装置可供所述线体穿设于其中，并具有剪切结构和剪切控 制结构，所述剪切控制结构可相对于所述剪切控制结构移动以控制所述剪切结构剪断所述线体。
  9. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述锁紧装置包括第一锁紧件、第二锁紧件、输送件和辅助件；其中，所述第一锁紧件分别与所述第二锁紧件和所述输送件可轴向锁紧或解离；所述辅助件与所述第二锁紧件可拆卸连接，且用于辅助所述第二锁紧件沿轴向定位；所述第一锁紧件与所述第二锁紧件之至少其中一者用于穿设所述线体，并通过轴向锁紧所述第一锁紧件与所述第二锁紧件而锁紧所述线体并抵接于所述封堵装置上；所述输送件和所述辅助件可分别与所述第一锁紧件和所述第二锁紧件解离。
  10. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述分离装置包括外管和芯管；其中，
    所述外管包括外管通道和穿线结构，其中，所述外管通道轴向贯穿所述外管，所述穿线结构设于所述外管的外管远端并用于穿设所述线体；所述芯管可活动地穿设于所述外管通道中，并包括设于所述芯管的芯管远端的剪切结构；
    且其中，所述芯管可相对于所述外管朝所述外管远端的方向轴向移动，以使所述剪切结构切断穿设于所述穿线结构中的所述线体。
  11. 根据权利要求4所述的二尖瓣瓣环成形系统，其特征在于，所述分离装置包括外管、芯管和剪切组件；其中，
    所述外管用于定位所述线体；所述芯管可活动地穿设于所述外管内；所述剪切组件连接所述外管和所述芯管；
    且其中，所述芯管可沿所述外管的轴向往复移动，并带动所述剪切组件在非作用状态与作用状态之间切换，以剪切所述线体。
  12. 一种二尖瓣瓣环成形系统的操作方法，应用于根据权利要求1至11所述的二尖瓣瓣环成形系统，其特征在于，所述方法包括：
    提供所述二尖瓣瓣环成形系统的输送鞘管依次经由心脏的下腔静脉、右心房、房间隔进入左心房；
    提供所述二尖瓣瓣环成形系统的锚定装置连接线体，并借由所述输送鞘管进入所述心脏的左心房，以锚定所述左心房内二尖瓣后瓣上的至少一目标锚定位置，使得所述线体定位于所述二尖瓣后瓣的所述目标锚定位置上；
    提供所述二尖瓣瓣环成形系统的封堵装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的房间隔，以封堵并定位于所述房间隔上；
    提供所述二尖瓣瓣环成形系统的锁紧装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的右心房，以在所述右心房内调整所述线体相对于所述锁紧装置的定位位置，直至所述左心房内的所述二尖瓣后瓣与二尖瓣前瓣满足预设间隔距离，再提供所述锁紧装置针对所述线体执行锁紧操作并抵接于所述封堵装置上，使得所述二尖瓣后瓣与所述二尖瓣前瓣之间维持所述预设间隔距离；
    提供所述二尖瓣瓣环成形系统的分离装置穿设所述线体于其中，并借由所述输送鞘管抵达所述心脏的右心房，以针对所述右心房内的所述线体执行剪切操作。
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