WO2016150261A1 - 一种可以切割缝合线的垫片锁紧导管 - Google Patents

一种可以切割缝合线的垫片锁紧导管 Download PDF

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Publication number
WO2016150261A1
WO2016150261A1 PCT/CN2016/073702 CN2016073702W WO2016150261A1 WO 2016150261 A1 WO2016150261 A1 WO 2016150261A1 CN 2016073702 W CN2016073702 W CN 2016073702W WO 2016150261 A1 WO2016150261 A1 WO 2016150261A1
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WIPO (PCT)
Prior art keywords
suture
hole
coil
wire loop
cutting
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PCT/CN2016/073702
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English (en)
French (fr)
Inventor
王建安
张庭超
王永胜
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诺琅医疗科技（上海）有限公司
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Publication of WO2016150261A1 publication Critical patent/WO2016150261A1/zh

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Classifications

    • 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
    • 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
    • A61B17/0467—Instruments for cutting sutures
    • 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
    • A61B17/0491—Sewing machines for surgery

Definitions

  • the invention relates to the field of medical instruments, and in particular to a gasket locking catheter capable of cutting a suture.
  • Mitral regurgitation is a common valvular heart disease. Severe mitral regurgitation can lead to complications such as heart dilatation, heart failure, atrial fibrillation, and pulmonary hypertension. It causes palpitations, chest tightness, shortness of breath, and swelling of the extremities. If symptoms are not treated, they will eventually lead to death.
  • mitral annuloplasty For functional mitral regurgitation, surgery, especially mitral annuloplasty, is the standard treatment of choice. It is mainly used to surgically use sutures or rings to partially or completely enclose and reduce the mitral valve. The ring achieves the goal of reducing functional mitral regurgitation.
  • surgical procedures have the disadvantages of large trauma, long recovery period, and high risk of surgery. Many patients have inability to tolerate surgery due to advanced age, weakness, combined with various other diseases, and previous history of open chest surgery. Some patients have lost the opportunity for surgery.
  • US Pat. No. 8,382,829 describes a method of repairing the mitral valve and reducing mitral regurgitation, specifically: implanting an anchoring component at the posterior mitral valve leaflet, An additional anchoring component is implanted at the anterior mitral valve leaflet, and the two anchoring components are connected by at least one stretching component. If a certain external force is applied to the tensile component, the posterior leaflet can pull the forward leaflet, so that The cusp valve ring folds.
  • this surgical method is similar to surgical mitral annuloplasty, it reduces the mitral annulus in an interventional manner to reduce the mitral regurgitation. Compared with surgery, it has a small trauma and recovery period. Short, the advantage of relatively low risk of surgery.
  • U.S. document US20140094826 describes a gasket locking catheter which has been anchored by other catheters at corresponding positions on the mitral annulus by means of other catheters, and the two spacers are connected before each other.
  • a suture and the two sutures are extended to extend outside the body
  • the gasket locking catheter is introduced into the body along the suture and reaches the gasket, and then the control mechanism of the catheter is operated to pull the two sutures to make the two spacers
  • the distance is close to the formation of the annulus fold, and the position of the two sutures is locked and fixed by the lock to achieve the purpose of narrowing the annulus, finally releasing the buckle and withdrawing the catheter.
  • the two sutures attached to the spacer remain in the patient, extending from the annulus to the outside of the patient, requiring a dedicated tangential catheter to sever the suture.
  • U.S. Patent No. 8,911, 461 describes a tangential catheter in which the annulus of the annulus is folded. After the buckle has been released, the tangential catheter is introduced along the suture, the handle of the tangential catheter is operated, the suture is cut from the portion of the buckle, and the surgical operation is completed. .
  • the mitral regurgitation repair is performed by the surgical operation method in the above patent documents.
  • the gasket locking gasket is used to form the annulus fold
  • the tangential catheter is also required to be sutured in the patient.
  • the line is cut.
  • the operation procedure is complicated, the number of catheter instruments used is large, and various catheters are repeatedly introduced, which prolongs the operation time, resulting in a large trauma in the later stage of the patient and an increase in the operation cost.
  • the invention provides a gasket locking catheter capable of cutting a suture, which can directly cut the suture after locking the gasket, and does not need to re-introducing the tangential catheter, thereby reducing the number of catheters used during the operation and simplifying the operation.
  • the operation process reduces the operation time, reduces the risk of surgery, and reduces the economic burden on patients.
  • a gasket locking catheter capable of cutting a suture comprising a sliding sleeve inner sheath tube and an outer sheath tube, wherein an inner tube head is fixed at a distal end of the inner sheath tube, and the inner tube head is docked with a lock by a pin
  • the inner tube head has at least one suture hole and one wire loop hole, and at least a portion of the suture hole is between the wire ring hole and the pin, and the inner tube end is at the suture hole and A portion between the wire loop holes is provided with a shearing table for engaging the wire loop to cut the stitching.
  • At least a portion of the suture hole is between the wire ring hole and the pin, that is, regardless of the cross-sectional area of the wire ring hole and the pin, the wire ring hole and the pin are respectively approximated to one point (the wire ring hole and the respectively The center point of the pin), the line connecting the two points intersects the suture hole.
  • the wire loop hole and the pin are separated on both sides of the suture hole.
  • the use of the gasket locking catheter provided by the present invention to release the buckle includes the following steps:
  • the stitching hole and the pin are enveloped, that is, the wire loop forms a ring perpendicular to the axial direction of the catheter, and the stitch hole and the pin are located in the ring of the wire loop;
  • the end surface of the distal end of the inner tube head is provided with a coil groove distributed around the suture hole for accommodating the wire loop.
  • the coil grooves are two, which are respectively located on both sides of the suture hole.
  • each coil groove is in communication with the wire loop hole, and the other end is wound around the pin by a corresponding side of the stitch hole.
  • the side wall of the buckle is provided with a diagonal slit for accommodating the wire loop, and each coil groove extends away from one end of the wire loop hole to communicate with the oblique cut.
  • the wire loop enters the oblique cut from the hypotube through the coil groove and is wound around the pin.
  • the end surface of the distal end of the inner tube head abuts against the buckle, and the cable loop is enclosed in the coil groove.
  • the cable loop includes a hypotube and a coil fixed to the hypotube.
  • the hypotube is bored in the loop hole of the cable, and the coil encloses the suture hole and the pin inside.
  • the cross-sectional shape of the coil is angular.
  • the cross-sectional shape of the coil may be polygonal or fan-shaped, for example, a triangle or a quadrangle.
  • the coil is in the shape of a rod near the hypotube, that is, the cross-sectional shape is circular, and the cross-sectional shape of the portion far from the hypotube is angular.
  • the portion of the coil that is adjacent to the hypotube is also wrapped with a casing.
  • the sleeve can increase the breaking strength of the loop of the cable loop, ensuring that the loop of the cable loop can cut the stitch.
  • the invention can cut the gasket locking catheter of the suture, can not only fix the buckle, but also can realize the function of cutting the suture after the buckle is released, and does not need to add new components compared with the prior art. Part of the processing process is simple and easy to implement.
  • Figure 1 is a schematic view of the release of the spacer on the mitral annulus
  • FIG. 2 is a schematic view of a first embodiment of a wire loop
  • Figure 3 is an exploded view of the main components of the distal end of the gasket locking catheter
  • Figure 4 is a schematic view of the inner tube head of the inner sheath tube
  • Figure 5a is a cross-sectional view of the distal end portion of the inner sheath tube having a rectangular cross-section of the coil;
  • Figure 5b is a cross-sectional view of the distal end portion of the inner sheath tube having a semicircular cross section of the coil;
  • Figure 6 is a cross-sectional view of the spacer locking catheter distal assembly prior to gasket locking
  • Figure 7 is a schematic view showing the relative position of the wire loop and the inner tube head of the inner sheath before the gasket is locked;
  • Figure 8 is a cross-sectional view of the distal end assembly of the gasket locking catheter when the lead loop pulls the suture
  • Figure 9 is a schematic view of the gasket locking catheter after entering the human body
  • Figure 10 is a cross-sectional view of the distal end of the spacer locking catheter after the suture passes through the lumen of the catheter;
  • Figure 11 is a schematic view of the distal end assembly of the gasket locking catheter after the suture is locked
  • Figure 12a is a schematic view of the gasket locking catheter in the human body after the buckle is released;
  • Figure 12b is a cross-sectional view of the distal end assembly of the gasket locking catheter after the buckle is released;
  • Figure 13 is a schematic view showing the relative position of the wire loop and the suture after the buckle is released;
  • Figure 14 is a cross-sectional view of the distal end of the spacer locking catheter after the suture is severed
  • Figure 15 is a schematic view of the release of the buckle and the suture cutting
  • Figure 16 is a schematic view of a second embodiment of a wire loop
  • Figure 17 is a schematic illustration of three cross-sections of the coil in the wire loop.
  • 101 coil; 102, hypotube; 200, lock; 201, oblique cut; 202, chute; 300, outer sheath tube head; 301, chute; 400, pin; 500, inner tube Head; 501, coil groove; 502, wire loop hole; 503, suture hole; 504, pin hole; 600, outer sheath tube; 700, pulley; 800, wire loop; 801, hypotube; 802, coil; 901, suture; 902, suture; 1000, inner sheath; 1200, annulus; 1301, gasket; 1302, gasket; 8002, wire loop; 8012, hypotube; 8022 coil; 8032, casing .
  • proximal end refers to the end near the operator's position, which is the end that is remote from the operator's position.
  • the following is applied to the percutaneous mitral valve repair as an example to illustrate a gasket locking catheter, and those skilled in the art will appreciate that the spacer locking catheter is only used for percutaneous mitral valve repair.
  • the spacer locking catheter of the present invention includes, but is not limited to, for mitral valve repair, tricuspid valve repair, atrial septal prosthesis, and patent foramen ovale repair.
  • two shims are required to be released on the mitral annulus.
  • the two shims correspond to one anchor point respectively, and the mitral annulus is completed by contracting the distance between the two anchor points. Contraction.
  • the state in which the spacer 1301 and the spacer 1302 are released is as shown in FIG. 1.
  • the spacer 1301 and the spacer 1302 respectively anchor different positions on the annulus 1200, the spacer 1301 is connected with the suture 901, and the spacer 1302 is connected with the suture.
  • Line 902 suture 901 and the other end of suture 902 extend outside the body.
  • the wire loop 800 of the present embodiment is composed of a hypotube 801 and a coil 802, and a certain point on the coil 802 is fixedly connected to the hypotube 801.
  • the hypotube 801 can be a stainless steel or a nickel-titanium tube.
  • the coil 802 and the hypotube 801 can be connected by welding or mechanical pressing.
  • the coil 802 is a metal wire having a diameter of about 0.05 mm to 0.5 mm, and the material may be stainless steel, nickel titanium or the like.
  • the distal end of the coil 802 can be formed into a certain arc by heat setting or other shaping means.
  • the distal end of the shim locking catheter is comprised of an outer sheath tube head (outer sheath Tip head) 300, a latch 200, a pulley 700, a pin 400, and an inner tube head 500 of the inner sheath tube.
  • the inner tube head of the inner sheath tube is provided with a pin hole 504, a wire loop hole 502, a suture hole 503, and a coil groove 501.
  • the inner tube head 500 of the inner sheath tube may be made of a metal or a hard polymer material.
  • the pin hole 504 and the wire ring hole 502 are respectively located on both sides of the suture hole 503, and are symmetrically distributed with respect to the suture hole 503.
  • the pin hole 504 is for placing a pin 400 for passing the lead ring and the suture 901 and the suture 902;
  • the wire loop hole 502 is for passing the wire loop 800;
  • the coil groove 501 is for placing the wire loop 800 Coil 802.
  • the coil groove 501 is distributed around the suture hole 503.
  • the coil groove 501 is two, respectively located on both sides of the suture hole 503, and one end of each coil groove is connected with the wire ring hole 502, and the other end is connected.
  • the corresponding side of the suture hole 503 is wound around the pin 400.
  • the side wall of the buckle 200 is provided with a diagonal slit 201 for accommodating the coil 802, and the coil recess 501 extends away from one end of the wire loop hole 502 to communicate with the oblique slit 201.
  • FIG. 5a and 5b A schematic cross-sectional view of the inner tube head 500 of the inner sheath tube is shown in Figs. 5a and 5b.
  • the cross-sectional shape of the coil groove can be variously selected, for example, a square shape as shown in Fig. 5a and a semicircular shape as shown in Fig. 5b. , or any other shape that can be processed.
  • the connection of the components at the distal end of the gasket locking catheter is shown in Fig. 6.
  • the outer sheath tube head 300 and the outer sheath tube 600 are joined by welding, and the outer sheath tube head 300 and the outer sheath tube 600 are at the outermost layer of the distal end of the gasket locking catheter.
  • the inner tube head 500 of the inner sheath tube is fixedly butted against the inner sheath tube 1000.
  • the two ends of the pin 400 are respectively located in the pin hole 504 of the inner tube head 500 of the inner sheath tube and the pin hole of the buckle 200, wherein the pin 400 is fixedly connected with the inner sheath tube 1000, and the pin 400 and the lock 200 can be opposite to each other. mobile.
  • the pulley 700 can be relatively moved on the chute 301 of the outer sheath tube head 300 and the chute 202 of the striker 200.
  • the lead ring includes a hypotube 102 and a coil 101 fixed to the hypotube 102.
  • the hypotube 102 of the lead ring passes through the suture hole 503 of the inner tube head 500 and the inner cavity of the lock 200, and the coil 101 of the lead ring is required.
  • the distal end of the buckle 200 is exposed.
  • the coil 802 exposes the distal end of the wire loop hole 502, the coil 802 is placed in the coil groove 501 separately, and the coil is The distal portion of the 802 is required to be placed over the pin 400 such that the suture 901 and suture 902 enter the interior of the coil 802 while entering the suture hole 503 of the inner tube head 500.
  • the pull loop 800 is withdrawn, causing the distal end of the coil 802 to contact the suture 901 and the suture 902.
  • a certain amount is applied.
  • the force of the stitches 901 and 902 is cut by the coil 802 and the corners on the partition.
  • the suture 901 and the suture 902 are threaded into the coil 101 of the lead ring, and the length of 10 cm or more is pulled out, as shown in FIG. 8; the lead ring is pulled out of the spacer locking catheter by the operating handle, and the suture is simultaneously
  • the 901 and suture 902 enter the lumen of the striker 200 and inner cannula 500 and extend from the proximal end of the catheter, as shown in Figure 9, where a cross-sectional view of the distal assembly of the spacer locking catheter is shown in FIG.
  • the operating handle advances the outer sheath tube 600, and the pulley 700 is driven to unlock from the sliding slot 301 of the outer sheath tube head 300, so that the pulley 700 continues to move on the sliding slot 202 of the locking buckle 200 until it cannot move, that is, the sewing
  • the wire 901 and the suture 902 are fixed to the buckle 200 by being pressed by the pulley 700 as shown in FIG.
  • the pin 400 is removed from the pin hole of the latch 200, as shown in Figures 12a and 12b.
  • the coil 802 is also disengaged from the loop groove 501, and the suture 901 And suture 902 is in the middle of coil 802, as shown in FIG.
  • the suture 901 and the distal end of the suture 902 are pulled with a certain force, so that the suture 901 and the suture 902 are in a straightened state, while the handle is operated, and the loop 800 is pulled back, so that the coil 802 can smoothly suture the suture 901 and suture.
  • Line 902 is severed as shown in FIG.
  • the outer sheath tube 600 is folded back, and the posterior annulus 1200 is folded, as shown in FIG.
  • the outer sheath tube head 300, the buckle 200, the pulley 700, the pin 400, the inner tube head 500 of the inner sheath tube, and the wire loop 800 are connected and operated in the same manner as in the first embodiment.
  • the wire loop 8002 includes not only the hypotube 8012 and the coil 8022, but also a sleeve 8032 that is sleeved on a portion of the coil 8022 adjacent to the hypotube 8012.
  • the sleeve 8032 is used to increase the breaking strength of the coil 8022.
  • the sleeve 8032 may be a stainless steel or a nickel-titanium tube or a hypotube having a certain direction, or may be a polymer material such as PE, PTFE or PET.
  • the sleeve 8032 is a stainless steel or a nickel-titanium tube
  • the sleeve 8032 and the coil 8022 are connected by welding or mechanical pressing, and then fixedly connected to the hypotube 8012 by welding or mechanical pressing.
  • the sleeve 8032 is a polymer material, it is fixed to the surface of the coil 8022 by means of heat fusion, and then fixedly connected to the hypotube 8012 by mechanical pressing or hot melt.
  • the outer sheath tube head 300, the buckle 200, the pulley 700, the pin 400, the inner tube head 500 of the inner sheath tube, and the wire loop 800 are connected and operated in the same manner as in the second embodiment.
  • This embodiment differs from Embodiment 2 in the cross-sectional shape of the coil 8022.
  • the portion of the coil 8022 connected to the hypotube 8013 is a regular rod shape to ensure that the connection strength with the hypotube 8013 can meet certain requirements, and the cross-sectional shape of the coil 8022 away from the hypotube portion can be triangular (as shown in FIG. 17). (a) shown), diamond (as shown in (b) of Figure 17), or curved with a certain angle (as shown in (c) in Figure 17), etc., to ensure smooth cutting Line 901 and suture 902.

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Abstract

一种可以切割缝合线(901,902)的垫片(1301,1302)锁紧导管，包括滑动套接的内鞘管(1000)和外鞘管(600)，在内鞘管(1000)的远端固定有内管头(500)，该内管头(500)通过销子(504)活动对接有锁扣(200)，所述内管头(500)至少具有一个缝合线孔(503)和一个拉线环孔(502)，且缝合线孔(503)的至少一部分处在所述拉线环孔(502)和销子(504)之间，内管头(500)远端处在缝合线孔(503)和拉线环孔(502)之间的部位带有剪切台，该剪切台用于与拉线环(800)配合切断缝合线(901,902)。

Description

一种可以切割缝合线的垫片锁紧导管
本发明涉及医疗器械领域，具体涉及一种可以切割缝合线的垫片锁紧导管。
二尖瓣反流是一种常见的心脏瓣膜疾病，严重的二尖瓣反流可以导致心脏扩张、心衰、房颤、肺动脉高压等并发症，使病人出现心悸、胸闷、气促、四肢浮肿等症状，如果不加以治疗，最终会导致患者死亡。
针对功能性二尖瓣反流，外科手术特别是二尖瓣瓣环成形术是传统的标准治疗方法，它主要是通过外科方式，使用缝合线或者环形物，部分或完全包围和缩小二尖瓣环，达到减少功能性二尖瓣反流的目的。但是，外科手术具有创伤较大，恢复期长，手术风险高等缺陷，许多患者因高龄、虚弱、合并多种其他疾病、既往有开胸史等不能耐受手术而不具备开胸手术条件，这部分患者就丧失了手术治疗的机会。
随着经皮二尖瓣修复术的发展，美国专利文献US8382829介绍了一种修复二尖瓣并减少二尖瓣反流的方法，具体为：在二尖瓣后瓣叶处植入一个锚定组件，在二尖瓣前瓣叶处植入另外一个锚定组件，通过至少一个拉伸组件连接两个锚定组件，如果在拉伸组件上施加一定的外力，后瓣叶可以拉向前瓣叶，使得二尖瓣瓣环褶皱。这种手术方法虽然类似外科二尖瓣瓣环成形术，但是以介入的方式缩小二尖瓣瓣环，达到减少二尖瓣返流的目的，相比外科手术而言，具有创伤小、恢复期短、手术风险相对较低的优点。
美国文献US20140094826介绍了一种垫片锁紧导管，使用此垫片锁紧导管之前，已经通过其他导管在二尖瓣瓣环上相应的位置锚定两个垫片，并且两个垫片各连接一条缝合线，且两条缝合线并拢后一直延伸到体外，垫片锁紧导管沿缝合线导入体内并到达垫片部位，然后操作导管的控制机构，拉动两条缝合线使两个垫片的距离靠近形成瓣环褶皱，利用锁扣将两个缝合线的位置锁紧固定，达到缩小瓣环的目的，最后释放锁扣，并撤出导管。此时，垫片连接的两条缝合线仍留在患者体内，从瓣环部位一直延伸到患者体外，需要使用一个专用的切线导管来将缝合线切断。
美国专利文献US8911461介绍了一种切线导管，手术中待瓣环褶皱，锁扣已经释放后，沿缝合线导入该切线导管，操作切线导管的手柄，从锁扣的部位切断缝合线，完成手术操作。
综上可知，采用以上专利文献中的手术操作方式进行二尖瓣反流修复，在使用垫片锁紧导管锁紧垫片形成瓣环褶皱后，还需要导入切线导管将留在患者体内的缝合线切断。手术操作过程较复杂，使用的导管器械数量多，反复的导入各种导管，使手术时间延长，导致患者后期创伤偏大，同时也增加了手术费用。
本发明提供了一种可以切割缝合线的垫片锁紧导管，能够在锁紧垫片后，直接将缝合线切断，不需要再重新导入切线导管，减少手术过程中导管的使用数量，简化手术操作的过程，减少手术时间，降低手术风险，减少患者的经济负担。
一种可以切割缝合线的垫片锁紧导管，包括滑动套接的内鞘管和外鞘管，在内鞘管的远端固定有内管头，该内管头通过销子活动对接有锁扣，所述内管头至少具有一个缝合线孔和一个拉线环孔，且缝合线孔的至少一部分处在所述拉线环孔和销子之间，内管头远端处在缝合线孔和拉线环孔之间的部位带有剪切台，该剪切台用于与拉线环配合切断缝合线。
缝合线孔的至少一部分处在所述拉线环孔和销子之间，即不考虑拉线环孔和销子的截面积，将拉线环孔和销子分别近似为一点（分别为拉线环孔和销子的中心点），两点的连线与缝合线孔相交。
作为优选，所述拉线环孔和销子分处在缝合线孔的两侧。
利用本发明提供的垫片锁紧导管释放锁扣，包括以下步骤：
（1）将拉线环经拉线环孔引出后，包络缝合线孔以及销子，即拉线环形成一个垂直于导管轴向方向的圆环，缝合线孔以及销子位于拉线环的环内；
（2）将缝合线穿引进入缝合线孔，即缝合线穿过拉线环内；
（3）利用外鞘管驱动锁扣夹紧缝合线；
（4）回撤内鞘管将拉线环从销子上脱出，同时拉线环的线圈从内管头的线圈凹槽中脱出；
（5）回撤拉线环使缝合线贴靠剪切台，直至拉线环与剪切台配合切断缝合线；
（6）收回外鞘管和内鞘管，完成锁扣的释放。
为了避免拉线环与缝合线以及其余线圈之间的相互干涉，所述内管头远端的端面设有绕缝合线孔分布、用于容置拉线环的线圈凹槽。所述线圈凹槽为两条，分别位于缝合线孔的两侧。
各线圈凹槽的一端与拉线环孔连通，另一端经缝合线孔的对应一侧绕至销子附近。所述锁扣的侧壁设有用于容置拉线环的斜切口，各线圈凹槽远离拉线环孔的一端延伸至与斜切口相通。
所述拉线环自海波管起经线圈凹槽后进入斜切口并绕置在销子上。所述内管头远端的端面与锁扣之间相互抵靠，将拉线环封闭在线圈凹槽内。
所述拉线环包括海波管以及与海波管相固定的线圈，海波管穿设在所述拉线环孔内，线圈将缝合线孔以及销子包络在其内部。
所述缝合线孔和拉线环孔之间带有隔离部，所述剪切台为该隔离部上与缝合线孔相邻一侧的棱角。
所述线圈的截面形状带有棱角。所述线圈的截面形状可以为多边形或扇形，例如，三角形或者四边形。为了保证线圈与海波管的连接强度，在靠近海波管的部分，线圈为棒状，即截面形状为圆形，在远离海波管的部分截面形状带有棱角。
所述线圈靠近海波管的部分还包裹有套管。套管能够增加拉线环的线圈的断裂强度，保证拉线环的线圈能够将缝合线切断。
本发明可以切割缝合线的垫片锁紧导管，不仅能够固定锁扣，而且在锁扣释放后，能够实现切断缝合线的功能，与现有技术相比，也不需要增加新的组件，各部分加工工艺简单，易于实现。
图1为垫片释放在二尖瓣瓣环上示意图；
图2为拉线环的第一种实施方式示意图；
图3为垫片锁紧导管远端主要部件的爆炸图；
图4为内鞘管的内管头示意图；
图5a为线圈凹槽截面为矩形的内鞘管远端部分的剖视图；
图5b为线圈凹槽截面为半圆形的内鞘管远端部分的剖视图；
图6为垫片锁紧之前垫片锁紧导管远端组件的剖视图；
图7为垫片锁紧之前拉线环与内鞘管内管头的相对位置示意图；
图8为引线环拉动缝合线时垫片锁紧导管远端组件的剖视图；
图9为垫片锁紧导管进入人体后的示意图；
图10为缝合线穿过导管内腔后的垫片锁紧导管远端剖视图；
图11为缝合线被锁紧后的垫片锁紧导管远端组件示意图；
图12a为锁扣释放后垫片锁紧导管在人体内的示意图；
图12b为锁扣释放后垫片锁紧导管远端组件剖视图；
图13为锁扣释放后拉线环与缝合线的相对位置示意图；
图14为缝合线被切断后垫片锁紧导管远端组件剖视图；
图15为锁扣释放及缝合线切断后的示意图；
图16为拉线环的第二种实施方式的示意图；
图17为拉线环中线圈的三种断面示意图。
图中：101、线圈；102、海波管；200、锁扣；201、斜切口；202、滑槽；300、外鞘管管头；301、滑槽；400、销子；500、内管头；501、线圈凹槽；502、拉线环孔；503、缝合线孔；504、销孔；600、外鞘管；700、滑轮；800、拉线环；801、海波管；802、线圈；901、缝合线；902、缝合线；1000、内鞘管；1200、瓣环；1301、垫片；1302、垫片；8002、拉线环；8012、海波管；8022、线圈；8032、套管。
下面结合附图和具体实施例对本发明进行详细说明。文中所述近端是指靠近操作者位置的一端，所述远端为远离操作者位置的一端。以下采用本发明应用于经皮二尖瓣修复术为例来阐述垫片锁紧导管，本领域的普通技术人员应当知晓，该垫片锁紧导管用于经皮二尖瓣修复术仅用作举例，并不是对本发明的限制，本发明的垫片锁紧导管，包括但不限于用于二尖瓣修复术、三尖瓣修复术、房间隔修复术以及卵圆孔未闭修复术。
实施例1
实施经皮二尖瓣修复术时，需要先在二尖瓣瓣环上释放两个垫片，两个垫片分别对应一个锚定点，通过收缩两个锚定点的间距，完成二尖瓣瓣环的收缩。垫片1301和垫片1302完成释放的状态如图1所示，垫片1301和垫片1302分别锚定瓣环1200上的不同位置，垫片1301连接有缝合线901，垫片1302连接有缝合线902，缝合线901和缝合线902的另一端延伸至人体外。
如图2所示，本实施例所涉及的拉线环800由海波管801和线圈802组成，线圈802上的某一点与海波管801固定连接。海波管801可以是不锈钢或者镍钛管。线圈802与海波管801可以通过焊接或者机械压点的方式进行连接。
线圈802为直径约0.05mm-0.5mm的金属线丝，材质可采用不锈钢、镍钛等。线圈802的远端可以通过热定型或者其他定型方式形成一定的弧度。
如图3所示，垫片锁紧导管的远端由外鞘管管头（外鞘管Tip头）300、锁扣200、滑轮700、销子400及内鞘管的内管头500组成。
如图4所示，内鞘管的内管头设有销孔504、拉线环孔502、缝合线孔503以及线圈凹槽501。内鞘管的内管头500的材质可以是金属或者硬质高分子材料。销孔504和拉线环孔502分别位于缝合线孔503的两侧，且相对缝合线孔503呈中心对称分布。
销孔504用于放置销子400，缝合线孔503用于通过引线环以及缝合线901和缝合线902；拉线环孔502用于通过拉线环800；线圈凹槽501用于放置拉线环800的线圈802。
如图4所示，线圈凹槽501绕缝合线孔503分布，线圈凹槽501为两条，分别位于缝合线孔503的两侧，各线圈凹槽的一端与拉线环孔502连通，另一端经缝合线孔503的对应一侧绕至销子400附近。
锁扣200的侧壁设有用于容置线圈802的斜切口201，线圈凹槽501远离拉线环孔502的一端延伸至与斜切口201相通。
内鞘管的内管头500的剖面示意图如图5a、5b所示，线圈凹槽的截面形状可以有多种选择，例如，如图5a所示的方形、如图5b所示的半圆形，或者其他任何可以加工的形状。
垫片锁紧导管远端各组件的连接方式如图6所示。外鞘管管头300与外鞘管600通过熔接方式进行连接，外鞘管管头300与外鞘管600处于垫片锁紧导管远端的最外层。内鞘管的内管头500与内鞘管1000固定对接。销子400的两端分别处于内鞘管的内管头500的销孔504与锁扣200的销孔中，其中销子400与内鞘管1000固定连接，销子400与锁扣200可以相对移动。
滑轮700可以在外鞘管管头300的滑槽301和锁扣200的滑槽202上相对移动。引线环包括海波管102以及与海波管102固定的线圈101，引线环的海波管102穿过内管头500的缝合线孔503和锁扣200的内腔，引线环的线圈101需要露出锁扣200的远端。
如图7所示，拉线环800通过内鞘管的内管头500的拉线环孔502后，线圈802露出拉线环孔502的远端后，线圈802分开放置在线圈凹槽501中，且线圈802的远端部分需套在销子400上，这样设置使缝合线901和缝合线902在进入内管头500的缝合线孔503的同时，进入线圈802的内部。
缝合线孔503和拉线环孔502之间带有隔离部，隔离部上与缝合线孔503相邻一侧具有棱角（即剪切台）。
后撤内鞘芯1000的同时，内管头500后撤，锁扣200解锁，且拉线环800的线圈802从销子400上脱出。
在拉直缝合线901和缝合线902同时，后撤拉线环800，使线圈802的远端与缝合线901和缝合线902接触，当缝合线901和缝合线902处于拉伸状态时，施加一定的力，利用线圈802以及隔离部上的棱角将缝合线901和902切断。
本实施例的主要操作方法如下：
首先，将缝合线901和缝合线902穿入引线环的线圈101内，并拉出10cm以上的长度，如图8所示；通过操作手柄将引线环拉出垫片锁紧导管，同时缝合线901和缝合线902进入锁扣200和内管头500的内腔，并从导管近端伸出，如图9所示，此时垫片锁紧导管远端组件的剖视图如图10所示。
操作手柄使外鞘管600往前推进，带动滑轮700从外鞘管管头300的滑槽301中解锁，进而滑轮700继续在锁扣200的滑槽202上继续移动，直至不能移动，即缝合线901和缝合线902通过被滑轮700压紧的方式固定在锁扣200上，如图11所示。
继续后撤内鞘管1000，使销子400从锁扣200的销孔中移出，如图12a、图12b所示，此时，线圈802也从线环凹槽501中脱出，且缝合线901和缝合线902处于线圈802的中间，如图13所示。
用一定的力拉动缝合线901和缝合线902的远端，使缝合线901和缝合线902处于拉直状态，同时操作手柄，后拉拉线环800，使线圈802可以顺利将缝合线901和缝合线902切断，如图14所示。
后撤外鞘管600，褶皱后瓣环1200，如图15所示。
实施例2
在本实施例中，外鞘管管头300、锁扣200、滑轮700、销子400、内鞘管的内管头500以及拉线环800的连接方式及操作方式均与实施例1相同。
本实施例与实施例1的不同之处在于：拉线环8002的结构组成。如图16所示，拉线环8002不仅包括海波管8012和线圈8022，还包括套管8032，套管8032套设在线圈8022邻近海波管8012的部分。
套管8032用于增加线圈8022的断裂强度，套管8032可以是不锈钢或者镍钛管或者具有一定方向的海波管，也可以是PE、PTFE、PET等高分子材料。
如果套管8032为不锈钢或镍钛管，套管8032与线圈8022通过焊接或者机械压点的方式连接，然后同样采用焊接或者机械压点方式与海波管8012固定连接。
如果套管8032为高分子材料，其通过热熔的方式固定在线圈8022的表面，然后采用机械压点的方式或者热熔的方式与海波管8012固定连接。
实施例3
在本实施例中，外鞘管管头300、锁扣200、滑轮700、销子400、内鞘管的内管头500以及拉线环800的连接方式及操作方式均与实施例2相同。
本实施例与实施例2的不同之处在于：线圈8022的截面形状。
线圈8022与海波管8013连接的部分为规则的棒形，以保证与海波管8013连接强度可以达到一定要求，而线圈8022远离海波管部分的断面形状可以为三角形（如图17中的（a）所示）、菱形（如图17中的（b）所示）、或者带有一定角度的弧形（如图17中的（c）所示）等等，以保证能够顺利切断缝合线901和缝合线902。

Claims (12)

  1. 一种可以切割缝合线的垫片锁紧导管，包括滑动套接的内鞘管和外鞘管，在内鞘管的远端固定有内管头，该内管头通过销子活动对接有锁扣，其特征在于，所述内管头至少具有一个缝合线孔和一个拉线环孔，且缝合线孔的至少一部分处在所述拉线环孔和销子之间。
  2. 如权利要求1所述的可以切割缝合线的垫片锁紧导管，其特征在于，内管头远端处在缝合线孔和拉线环孔之间的部位带有剪切台，该剪切台用于与拉线环配合切断缝合线。
  3. 如权利要求1所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述拉线环孔和销子分处在缝合线孔的两侧。
  4. 如权利要求1至3任一所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述内管头远端的端面设有绕缝合线孔分布、用于容置拉线环的线圈凹槽。
  5. 如权利要求4所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述线圈凹槽为两条，分别位于缝合线孔的两侧。
  6. 如权利要求5所述的可以切割缝合线的垫片锁紧导管，其特征在于，各线圈凹槽的一端与拉线环孔连通，另一端经缝合线孔的对应一侧绕至销子附近。
  7. 如权利要求5所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述锁扣的侧壁设有用于容置拉线环的斜切口，各线圈凹槽远离拉线环孔的一端延伸至与斜切口相通。
  8. 如权利要求1所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述缝合线孔和拉线环孔之间带有隔离部，所述剪切台为该隔离部上与缝合线孔相邻一侧的棱角。
  9. 如权利要求4所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述内管头远端的端面与锁扣之间相互抵靠，将拉线环封闭在线圈凹槽内。
  10. 如权利要求1~3任一所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述拉线环包括海波管以及与海波管相固定的线圈，海波管穿设在所述拉线环孔内，线圈将缝合线孔以及销子包络在其内部。
  11. 如权利要求10所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述线圈的截面形状带有棱角。
  12. 如权利要求10所述的可以切割缝合线的垫片锁紧导管，其特征在于，所述线圈靠近海波管的部分还包裹有套管。
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