WO2019184649A1 - Système de réparation de valvule cardiaque et son dispositif de blocage de suture - Google Patents

Système de réparation de valvule cardiaque et son dispositif de blocage de suture Download PDF

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Publication number
WO2019184649A1
WO2019184649A1 PCT/CN2019/076509 CN2019076509W WO2019184649A1 WO 2019184649 A1 WO2019184649 A1 WO 2019184649A1 CN 2019076509 W CN2019076509 W CN 2019076509W WO 2019184649 A1 WO2019184649 A1 WO 2019184649A1
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WO
WIPO (PCT)
Prior art keywords
suture
locking
cavity
mandrel
heart valve
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PCT/CN2019/076509
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English (en)
Chinese (zh)
Inventor
张庭超
张伟伟
孟旭
潘湘斌
郑贤章
Original Assignee
杭州德晋医疗科技有限公司
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Publication of WO2019184649A1 publication Critical patent/WO2019184649A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • 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
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; 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
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06004—Means for attaching suture to needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac

Definitions

  • the invention belongs to the technical field of medical instruments, and relates to a heart valve repair system and a suture locking device thereof.
  • the mitral valve is a one-way "valve" between the left atrium (abbreviation: LA) and the left ventricle (abbreviation: LV), which ensures blood flow from the left atrium to the left ventricle.
  • the leaflet of the mitral valve is divided into the anterior lobe 1010 and the posterior lobe 1020.
  • the left ventricle When the left ventricle is in the diastolic state, the two are in an open state, blood flows from the left atrium to the left ventricle; when the left ventricle is in a contracted state, the chordae tendon is stretched. So that the leaflets are not washed by the bloodstream to the atrial side.
  • Figures 1a to 1b show a normal healthy mitral valve with good anterior and posterior lobes to ensure blood flow from the left ventricle through the aortic valve (abbreviation: AV) to the aorta.
  • the mitral valve shown in Fig. 2a to Fig. 2b has a lesion.
  • the mitral valve cannot return to a closed state like a normal state, forming a large pore G, and the impulse of blood flow further causes the valve. Leaves detached into the left atrium, causing blood to flow back.
  • the edges of the two leaflets form a "double-pored" mitral valve.
  • This method of interventional therapy needs to be sent to the mitral valve clamp through a complicated tortuous path in the patient's body. It is impossible to visually observe whether the position of the mitral valve clamp in the patient's heart is reasonable, and the operator can only operate remotely in vitro.
  • the cusp clamp clamps the valve leaflets and releases the leaflets, so the operation time is longer and the success rate is lower.
  • the technical problem to be solved by the present invention is to provide a heart valve repair system for the above-mentioned defects in the prior art, which can rapidly perform a valve repair operation for mitral regurgitation through a apical path.
  • a heart valve repair system comprising a suture having a certain axial length, a suture implant device for implanting a suture into a leaflet of a heart valve, and a suture lock device securing the suture.
  • the suture implant device includes a push catheter, a clamping assembly for clamping the leaflets, and a piercing assembly for piercing the leaflets, the clamping assembly and the piercing assembly are movably disposed in the push catheter, and the suture is placed in the clip Holding the component.
  • the suture locking device includes a suture clasp for securing the suture, a latch push device detachably coupled to the suture clasp, and a push control device for securing and disengaging the suture clasp.
  • a suture locking device for fixing a suture implanted on a leaflet of a heart valve comprising a suture lock for fixing a suture, and a latch pushing device detachably coupled to the suture buckle And a push control device for fixing and releasing the suture lock.
  • the heart valve repair system of the present invention has at least the following beneficial effects:
  • the heart valve repair system of the invention is suitable for the valvular repair operation of the mitral regurgitation through the apical path, and can quickly realize the chordae repair or the edge-to-edge repair of the mitral valve.
  • the patient's apex puncture first penetrates the distal end of the clamping component into the patient's heart, drives the opening and closing of the clamping component to clamp the leaflets of the anterior lobe of the mitral valve and the leaflets of the posterior lobe, and then pushes
  • the puncture assembly pierces the leaflet and is combined with the fixing member at the end of the suture, and the puncture component is retracted to drive the suture to retreat, and the suture locking device is inserted into the patient's heart, and the suture locking buckle is driven.
  • the sutures are secured together to pull the anterior and posterior lobes of the mitral valve toward each other for "edge-to-edge repair” to reduce or eliminate the gap between the leaflets, resulting in a double mitral valve after repair Hole.
  • the heart valve repair system of the present invention can treat organic reflux and functional reflux of the mitral valve, and the whole surgical procedure only forms a small wound on the chest of the patient, and such minimally invasive surgery avoids the traditional thoracotomy for the patient.
  • the damage of the heart valve repair system is easy to operate, avoiding the tedious steps of the prior art transcatheter repairing the mitral valve, which has a high success rate and a short time.
  • Figure 1a to Figure 1b are schematic illustrations of a normally closed mitral valve in the heart
  • FIGS. 2a to 2b are schematic views of a mitral valve that is not normally closed in the heart
  • FIG. 3 is a schematic structural view of a heart valve repair system of the present invention.
  • Figure 4 is a schematic view showing the structure of the suture in Figure 3;
  • 5a to 5c are schematic structural views of different embodiments of a suture
  • Figure 6 is a schematic structural view of the suture implantation device of Figure 3.
  • Figure 7 is an exploded view of the suture implanting device of Figure 6;
  • Figure 8 is a schematic view showing the structure of the suture implanting device of Figure 6 when the clamping assembly is opened;
  • FIG. 9 is a schematic structural view showing the puncture needle of the puncture assembly of the suture insertion device of FIG. 6 connected to the fixing member of the suture;
  • Figure 10a is a schematic view showing the structure of the distal collet in the suture implanting device of Figure 6;
  • Figure 10b is a cross-sectional view taken along line B-B of Figure 10a;
  • 11a-11b are schematic structural views of different embodiments of a clamping aid assembly of the suture implanting device of FIG. 6;
  • Figure 12 is an axial cross-sectional view of the distal end of the push catheter of the suture implant device of Figure 6;
  • Figure 13a is a schematic view showing the structure of the distal end of the suture implantation device
  • Figure 13b is a schematic view showing the structure of the clamping aid assembly of the suture implanting device of Figure 13a supported on the lower surface of the leaflet;
  • FIG. 14a to 14g are schematic structural views of different embodiments of the clamping aid assembly of the suture implantation device of Fig. 6;
  • Figure 15 is a schematic view showing the structure of the detecting assembly of the suture implanting device of Figure 6;
  • Figure 16 is a schematic view showing the structure of the probe assembly of Figure 15 being worn in a pusher catheter;
  • Figure 17 is a radial cross-sectional view of the push catheter of the suture implant device of Figure 6;
  • 18a to 18c are schematic views of a process of detecting a leaflet of a probe assembly
  • Figure 19 is a schematic view showing the appearance of the suture locking device of Figure 3.
  • Figure 20 is an exploded view of the suture fastening device of Figure 19;
  • 21a to 21c are schematic views showing the structure of the suture lock of the suture fastening device of FIG. 19 in cooperation with the buckle pushing device;
  • 22a and 22b are schematic structural views of the suture clasp of FIG. 19;
  • 23a to 23c are schematic cross-sectional structural views of the locking pin at different positions of the locking body
  • 24a to 24c are schematic views showing a process of fixing two sutures by a suture lock
  • Figure 25 is a schematic view of a suture clasp for securing a plurality of sutures
  • Figure 26 is a schematic view showing the internal structure of the suture locking device
  • Figure 27 is a partial enlarged view of I in Figure 26;
  • FIG. 28 is a schematic structural view of a proper amount of the screwing control mechanism of the suture fastening device
  • Figure 29 is a schematic structural view of a drive coupling of a suture fastening device
  • Figure 30 is a schematic view showing the appearance of another embodiment of a suture fastening device
  • Figure 31 is a partially enlarged internal structural view of the suture fastening device
  • 32 to 43 are schematic views showing a process of repairing a mitral valve using the heart valve repair system of the present invention.
  • Azimuth definition The following is defined as the near end of the operator, and the position away from the operator is defined as the far end.
  • a heart valve repair system includes a suture 3000 having a certain axial length, a leaflet for implanting the suture 3000 into the heart valve (e.g., the anterior and posterior mitral valve)
  • the suture implant device 1000 of the leaf and the suture lock device 2000 of the fixed suture 3000.
  • the suture implant device 1000 includes a push catheter 1210, a clamp assembly 1300 for gripping the leaflets, and a piercing assembly 1400 for piercing the leaflets.
  • the clamping assembly 1300 and the piercing assembly 1400 are movably threaded through the pusher catheter 1210. Suture 3000 is received in clamping assembly 1300.
  • the suture lock device 2000 includes a suture clasp 2100 for securing the suture 3000, a latch push device 2200 detachably coupled to the suture clasp 2100, and a control for securing and releasing the suture clasp 2100.
  • the control device 2300 is pushed.
  • the suture 3000 has a certain axial length and is flexible. At least one end of the two ends of the suture 3000 is connected with a fixing member 3010. As shown in FIG. 4, a fixing member 3010 may be disposed at both ends of the suture 3000; as shown in FIGS. 5a to 5c, a fixing member 3010 is provided only at one end of the suture 3000.
  • the fixing member 3010 is non-detachably connected or detachably connected to the piercing assembly 1400. Preferably, both ends of the suture 3000 are provided with a fixing member 3010 (as shown in FIG. 4).
  • each suture 3000 is secured to the leaflets, the ends are secured to the papillary muscles, apex, or ventricular wall by a suture lock device 2000, or all sutures 3000 that pass through the leaflets are passed through a suture lock device 2000. They are secured together to pull the plurality of leaflets of the valve toward each other.
  • the fact that the suture 3000 has flexibility means that it can be bent freely without stretching in the axial direction.
  • the suture 3000 can be made of a biocompatible polymer material or a relatively soft metal material, and is preferably a polymer material such as PTFE or PP. In this embodiment, an ePTFE material is used.
  • connection between the suture 3000 and the fixing member 3010 may be knotting, winding, welding, bonding, snapping, or the like.
  • one end of the suture 3000 can be knotted out of the fixture 3010 to form a larger diameter coil; or the end can be welded to a larger diameter ball; or a lateral positioning rod can be placed at the end.
  • the other end should be knotted, wound, or provided with a spherical end, a disc-shaped end, etc., so that the other end is The cross-sectional dimension is greater than the cross-sectional dimension of the suture 3000.
  • one end of the suture 3000 is retracted together with the piercing assembly 1400 by the fastener 3010, and the other end of the suture 3000 can be blocked against the upper surface of the leaflet.
  • the shape of the fixing member 3010 is generally cylindrical, and the cross-sectional shape may be various shapes such as a circular shape, an elliptical shape, a polygonal shape, and the like, and is preferably circular or elliptical.
  • the sutures 3000 are overlaid with a cleat 3020 and the cleats 3020 can slide axially along the sutures 3000. Since the anti-slip member 3020 is previously disposed on the suture 3000, after the puncture needle 1410 of the suture implanting device 1000 punctures the leaflet and is coupled with the fixing member 3010 of the suture 3000, the anti-slip member 3020 can be driven to the puncture point, and The sutures 3000 are fixed together on the leaflets.
  • a through hole 3021 is provided in the slip preventing member 3020 for the suture 3000 to pass therethrough.
  • the number of the through holes 3021 is set in relation to the manner in which the slip preventing member 3020 is fixed.
  • One way is to provide at least two through holes 3021 on the anti-slip member 3020. Both ends of one suture 3000 are respectively connected to a fixing member 3010 through different through holes 3021 (as shown in FIG. 4).
  • Another way is to provide a through hole 3021 on the anti-slip member 3020.
  • One end of the suture 3000 passes through the through hole 3021 and is connected to the fixing member 3010 (as shown in FIGS. 5a and 5b).
  • the cross-sectional dimension of the through-hole 3021 is smaller than the cross-sectional dimension of the fixing member 3010, and the other end of the suture 3000 not provided with the fixing member 3010 should pass knotting, or set the spherical end, the disc.
  • the end of the shape or the like is such that the cross-sectional dimension of the other end is larger than the cross-sectional dimension of the through hole 3021 on the anti-skid member 3020 (as shown in FIG. 5b).
  • the anti-slip member 3020 In order to disperse the force of the suture line 3000 on the leaflet as far as possible to the contact surface between the anti-slip member 3020 and the leaflet, the anti-slip member 3020 needs to be attached to the leaflet as much as possible, so that the anti-slip member 3020 is provided with a sticker attached to the leaflet. Face 3022.
  • the specific structure of the anti-slip member 3020 is not limited, and may be, for example, a sheet shape having a certain area, a disk shape or a spherical shape, or even an irregular shape, and is preferably a sheet shape.
  • the anti-slip member 3020 may be a non-porous structure, or may be a mesh structure, a bar-like structure, or the like.
  • the slip resistant member 3020 should be made of a biocompatible elastomeric or non-elastic material.
  • the cleat 3020 is selected from at least one of an elastic spacer, a heart patch, a felt sheet, a mesh structure, a disc-like structure, or a double disc-like structure.
  • the structure of the anti-slip member 3020 having a disc-like structure or a double disc-like structure is similar to the occluder in the prior art, and will not be described herein.
  • the cleat 3020 having a disc-like structure or a double disc-like structure should be made of a shape memory material.
  • a polyester cloth gasket is used as the slip preventing member 3020.
  • the suture implant device 1000 is used to implant the suture 3000 into the leaflets of the valve.
  • the suture implant device 1000 includes a clamp assembly 1300, a piercing assembly 1400, and a push catheter 1210.
  • the pusher catheter 1210 is a tubular body having a certain axial length or a rod-shaped body having a lumen.
  • the pusher catheter 1210 can be an integrally formed multi-lumen tube, or the outer tube and the inner tube set can be secured together to form a unitary structure.
  • the pusher catheter 1210 can be made of a biocompatible polymer material (for example, polyoxymethylene POM, polyethylene PE, nylon PA, polyvinyl chloride PVC, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or Polyurethane PU), metal material (for example, stainless steel or nickel titanium alloy) or metal-polymer composite material.
  • the pusher catheter 1210 is a rod-shaped body in which a plurality of lumens that are spaced apart from each other and penetrate the both ends of the pusher catheter 1210 are provided in the axial direction.
  • the proximal end of the push catheter 1210 is provided with a first handle 1201 for manipulating the push catheter 1210 to push distally or to withdraw proximally.
  • the puncture assembly 1400 is movably worn in a lumen of the push catheter 1210.
  • the puncture assembly 1400 includes two puncture pushers 1420 and two puncture needles 1410 respectively disposed at the distal ends of the puncture pushers 1420.
  • the number of piercing push rods 1420 corresponds to the number of fasteners 3010.
  • both ends of the suture line 3000 are provided with fixing members 3010. Therefore, two puncture push rods 1420 are installed side by side in the pushing duct 1210, and each of the two puncture needles 1410 corresponds to one fixing member. 3010.
  • the puncture needle 1410 can be coupled to the fixation member 3010 of the suture 3000 after the puncture of the leaflet, and the retraction puncture pusher 1420 can pull the suture 3000 toward the proximal end.
  • the distal end of the puncture needle 1410 is a conical straight tip to facilitate puncture of the leaflets and reduce the diameter of the puncture point formed on the leaflets.
  • a needle having a hooked end is passed through the leaflet and the suture 3000 is withdrawn, and then the needle is retracted to drive the suture 3000 through the leaflet.
  • the needle having the hooked end is formed on the leaflet.
  • the puncture point is too large, and the damage to the leaflets is large, which not only affects the postoperative recovery process, but also increases the risk of tearing of the valve leaflets after surgery.
  • the tapered tip of the cone forms a small puncture point on the leaflets, which is beneficial to the patient's postoperative healing.
  • the suture insertion device 1000 of the present embodiment has a single puncture point formed on each leaflet having a diameter ranging from 0.3 mm to 1.5 mm. Further, by selecting the shape and diameter of the appropriate puncture needle 1410, the diameter of the puncture point can be controlled to be about 0.7 mm.
  • detachable or non-detachable connection between the puncture needle 1410 and the fixing member 3010 such as a threaded connection, a bonding, a rough surface friction connection, an interference fit or a snap connection.
  • a snap connection is used.
  • a groove or a hole is provided in the inner surface of the fixing member 3010, and is engaged with a protrusion or a convex edge provided on the puncture needle 1410.
  • three recesses 3125 are radially disposed on the inner surface of the fixing member 3010, and are engaged with the flange 1411 on the puncture needle 1410.
  • the three recesses 3125 ensure the stability of the connection between the fixing member 3010 and the puncture needle 1410, reduce the amplitude of the shaking of the puncture needle 1410 after the connection, and do not additionally increase the diameter of the puncture needle 1410, resulting in an increase in the diameter of the puncture point.
  • the prior art hook needle has a lower probability of hooking the suture 3000, resulting in a lower surgical success rate and prolonging the operation time; and after the needle hooks the suture 3000, since the needle and the suture 3000 pass only a weak Frictional connection, during the process of withdrawing the needle, due to the blood flow of the patient or the movement of the operator, may cause the suture 3000 to fall off the needle, resulting in a surgical failure.
  • the puncture needle 1410 of the embodiment forms a stable and reliable connection with the fixing member 3010 of the suture 3000.
  • the suture 3000 is not easily separated from the fixing member 3010, and the operator can conveniently and quickly connect the end of the suture 3000 to the fixing member 3010 or Both ends retreat.
  • the proximal end of the puncture needle 1410 is coupled to a puncture pusher 1420 that is movably worn in the lumen of the push catheter 1210.
  • the proximal end of the puncture pusher 1420 is threaded from the proximal end of the push catheter 1210 and is coupled to the third handle 1401.
  • the axial movement of the third handle 1401 can drive the puncturing push rod 1420 to move along the axial direction of the push catheter 1210, thereby driving the puncture needle 1410 to puncture distally or retrace to the proximal end.
  • the clamping assembly 1300 includes a clamping pusher 1330 for receiving the suture 3000 and a distal collet 1310 and a proximal collet 1320 that are relatively open to engage the leaflets.
  • the clamping pusher 1330 is movably worn in the pusher catheter 1210.
  • the distal collet 1310 is disposed at a distal end of the clamp pusher 1330
  • the proximal collet 1320 is disposed at a distal end of the push catheter 1210.
  • the proximal end of the clamp pusher 1330 is threaded out of the proximal end of the push catheter 1210 and the second handle 1301 is disposed.
  • the second handle 1301 is pushed distally to move the clamping pusher 1330 distally, so that the distal collet 1310 is away from the proximal collet 1320, forming an open state of the clamping assembly 1300, as shown in FIG.
  • a leaflet accommodating space is formed between the distal collet 1310 and the proximal collet 1320.
  • the second handle 1301 is retracted proximally, so that the distal collet 1310 approaches the proximal collet 1320, forming a closed state or a clamping state of the clamping assembly 1300, as shown in FIG. Shown.
  • the shape of the proximal collet 1320 and the distal collet 1310 should be consistent with the shape of the push catheter 1210.
  • the distal collet 1310 and the proximal collet 1320 should form a smooth overall after closing to facilitate pushing and reducing the pair. Damage to the patient's wound.
  • the proximal collet 1320 may not be separately provided, but the distal end of the push catheter 1210 may be directly used as the proximal collet 1320, and cooperated with the distal collet 1310 to clamp Hold the leaflets.
  • the pusher catheter 1210 is preferably a rod-shaped body having a plurality of compartments separated by a distal end surface of the rod-shaped body as a gripping surface of the leaflets.
  • the gripping surface of the proximal collet 1320 ie, the distal end surface of the proximal collet 1320
  • the gripping surface 1311 of the distal collet 1310 ie, the distal collet 1310
  • the proximal surface should be adhered to each other, and the clamping surface of the proximal collet 1320 and the clamping surface 1311 of the distal collet 1310 respectively have a larger leaflet contact area, for example, the two can be respectively inclined, that is, both An acute angle of less than 90 degrees with the axis of the pusher catheter 1210.
  • a clamping surface for enhancing the clamping force is provided on the clamping faces of the distal collet 1310 and/or the proximal collet 1320.
  • the clamping reinforcement is preferably at least one of a projection, a rib, a groove or a recess, and the shape of the clamping reinforcement provided by the clamping surface 1311 of the distal collet 1310 should be similar to that of the proximal collet 1320 The shape of the clamping reinforcement provided by the clamping faces cooperates such that there is no gap between the closed distal collet 1310 and the proximal collet 1320.
  • the clamping faces 1311 of the distal collet 1310 and the clamping faces of the proximal collet 1320 are respectively provided with a plurality of parallel ribs as clamping reinforcements, and when the clamping assembly 1300 is closed, the distal end There is no gap between the collet 1310 and the proximal collet 1320.
  • the clamping pusher 1330 is a tubular body or a hollow rod-shaped body having a certain axial length.
  • the cross section is preferably elliptical, semi-circular, crescent or circular, and the clamping push A suture passage 1331 is provided in the rod 1330 in the axial direction.
  • the distal collet 1310 is provided with two suture receiving cavities 1315 communicating with the suture channel 1331, and the two suture receiving cavities 1315 are respectively penetrated to the clamping faces 1311 of the distal collet 1310.
  • the suture 3000 is housed in the suture channel 1331 and the suture receiving cavity 1315.
  • the clamping faces 1311 of the distal collet 1310 are provided with two fixing cavities 1313 for accommodating the two fixing members 3010 of the suture 3000, respectively.
  • Each of the fixed cavities 1313 is in axial communication with a suture receiving cavity 1315.
  • the positions of the two fixed cavities 1313 correspond to the positions of the two puncture needles 1410, respectively.
  • the suture 3000 is placed and fixed inside the suture implanting device 1000, thereby avoiding the damage of the suture 3000 caused by the suture 3000 when the suture implanting device 1000 enters the patient, and avoiding blood in the body. Leakage around the suture 3000.
  • the distance between the fixed cavity 1313 and the clamping push rod 1330 is the distance between the suture line 3000 and the edge of the leaflet after implantation, which can effectively avoid the folding of the edge of the leaflet and the formation of a gap to enhance the surgical effect.
  • the clamping surface 1311 of the distal collet 1310 is provided with a receiving groove 1314 for receiving the anti-slip member 3020.
  • the receiving groove 1314 and the two suture receiving cavities 1315 are respectively in radial communication. Therefore, after the two puncture needles 1410 respectively puncture the leaflets and connect with one fixing member 3010, the two puncture push rods 1420 are withdrawn, and the two puncture needles 1410 and the fixing members 3010 and the sutures 3000 connected thereto are respectively driven.
  • the anti-slip members 3020 are sequentially pulled out by the clamping faces 1311 of the distal collet 1310 until the puncture needles 1410, the fasteners 3010 and the sutures 3000 are sequentially passed through the leaflets, and the anti-slip members 3020 are attached to the upper surface of the leaflets.
  • the fixing cavity 1313 and the receiving groove 1314 are arranged to pull the suture 3000 and the anti-slip member 3020 to the leaflets without having to loosen the distal collet 1310 and the proximal collet 1320, so that the clamping assembly 1300 is closed.
  • the leaflets are detached from the clamping assembly 1300 and the pulsation is resumed, the anti-slip member 3020 is attached to the leaflets to stabilize the lobed leaflets, and the linear cutting of the suture 3000 is prevented from generating the pulsating valve leaflets. hurt.
  • the fixing cavity 1313 functions to fix the fixing member 3010 of the suture 3000 in the fixing cavity 1313, and can be smoothly pulled out from the fixing cavity 1313 after the fixing member 3010 is pulled by the external force. Therefore, the shape of the fixed cavity 1313 matches the shape of the fixing member 3010, and the diameter of the inscribed circle of the fixed cavity 1313 is larger than the diameter of the circumscribed circle of the suture receiving cavity 1315. Preferably, the ratio of the diameter of the circumscribed circle of the suture receiving cavity 1315 to the diameter of the inscribed circle of the fixed cavity 1313 is (0.2 to 0.4):1.
  • the diameter of the inscribed circle of the fixed cavity 1313 is the diameter of the circular cross section of the fixed cavity 1313, and the circumcircle of the suture receiving cavity 1315 The diameter is the diameter of the circular cross section of the suture receiving cavity 1315.
  • the fixed cavity 1313 has a circular cross section and a diameter D1.
  • the suture receiving cavity 1315 has a circular cross section with a diameter D2 and D2 is 30% of D1.
  • the purpose of the setting is that if the D2 is too large, the puncture needle 1410 is engaged with the fixing member 3010 of the suture 3000 under the pushing of the puncture pusher 1420, and the fixing member 3010 may be from the distal end of the puncture pusher 1420.
  • the fixed cavity 1313 is slid into the suture receiving cavity 1315, so that the puncture needle 1410 and the fixing member 3010 of the suture 3000 cannot be successfully connected at one time, which may prolong the operation time; if the D2 is too small, the suture 3000 of the suture 3000 is 3000.
  • the smooth passage of the suture receiving cavity 1315 is not possible, and after the puncture needle 1410 is connected to the fixing member 3010 of the suture 3000, the suture thread 3000 cannot be smoothly pulled out of the clamping surface of the clamping pusher 1330.
  • the fixed cavity 1313 and the receiving groove 1314 are in radial communication.
  • the width D3 of the communicating portion between the fixed cavity 1313 and the receiving groove 1314 is 20%-50% of D1
  • the purpose of the setting is that if the D3 is too large, the fixing member 3010 of the suture 3000 cannot be firmly fixed at The fixed cavity 1313 of the distal collet 1310 is easily slipped from the fixed cavity 1313, which directly causes the instrument to fail; if the D3 is too small, the fixing member cannot be smoothly after the puncture needle 1410 is connected with the fixing member 3010 of the suture 3000. The 3010 is pulled out of the fixed lumen 1313, causing the surgery to fail.
  • a suture attachment device 1500 is also provided in the suture implant device 1000.
  • the gripping aid assembly 1500 includes at least one gripping aid arm 1520 that is movably threaded into the pusher catheter 1210 and a gripping aid 1510 that is disposed at the distal end of the gripping arm 1520.
  • a fourth handle 1501 can also be provided at the proximal end of the clamp auxiliary arm 1520.
  • an auxiliary arm housing chamber 1250 is provided in the pushing duct 1210 in the axial direction.
  • the clamping aid 1510 and the clamping auxiliary arm 1520 are both housed in the auxiliary arm receiving cavity 1250.
  • the clamping surface of the proximal collet 1320, the side wall of the push catheter 1210 or the side wall of the proximal collet 1320 is provided with an opening 1260, and the opening 1260 is penetrated with the auxiliary arm receiving cavity 1250, when the operator pushes the distal end A four-handle 1501 that drives the clamping assist arm 1520 to push the clamping aid 1510 out of the opening 1260 (as shown in Figure 13a) to support the lower surface of the leaflet 600, stabilizing the beating flaps 600, reducing The amplitude of movement of the leaflets 600 cooperates with the clamping assembly 1300 to clamp and secure the leaflets 600 (as shown in Figure 13b).
  • the angle ⁇ between the axial direction of the distal end portion of the auxiliary arm housing chamber 1250 and the axial direction of the push catheter 1210 ranges from 120° to 150°.
  • the reason for this arrangement is that before the puncture, the clamping pusher 1330 is in contact with the edge of the leaflet, and the distal collet 1310 and the proximal collet 1320 can only clamp part of the leaflets, in order to keep the beating leaflets as stable as possible.
  • the angle between the clamping aid 1510 and the push catheter 1210 is substantially equal to the axial direction of the distal end of the auxiliary arm receiving cavity 1250 and the push catheter 1210 The angle ⁇ between the axial directions.
  • the clamping aid 1510 is a rod-like structure composed of at least one support rod.
  • the grip aid 1510 is made of a biocompatible elastic and/or flexible material to accommodate the anatomy of the leaflets and the amplitude of movement of the leaflets and to avoid damage to the leaflets.
  • the elastic material is preferably a shape memory material.
  • the clamping aid 1510 can be made of a metallic material, a polymeric material, or a metal-polymer composite.
  • the support rod may be a solid or hollow structure of a single layer or a multi-layer composite structure, or may be wound from a single wire or a plurality of wires.
  • the cross section of the support rod may be a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape, or the like.
  • the clamping aid 1510 has a smooth outer shape, and the distal end is formed by a laser spot welding to form a smooth round head without defects such as burrs, edges or corners.
  • the clamping aid 1510 is a support rod made of Nitinol and has a circular cross section.
  • the clamping auxiliary arm 1520 is rod-shaped or tubular having a certain axial length and has a certain hardness or rigidity to provide support and pushability.
  • the clamping auxiliary arm 1520 may be a metal rod or a polymer material rod of a hollow or solid structure of a single layer or a multi-layer composite structure, or may be wound from a single wire or a plurality of wires.
  • the cross section of the clamping auxiliary arm 1520 may be a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape, or a ring shape.
  • the clamping auxiliary arm 1520 can be made of a metallic material, a polymeric material, or a metal-polymer composite.
  • the clamping aid arm 1520 is made of a hard material; the clamping aid 1510 is made of a resilient and/or flexible material. It can be understood that the clamping auxiliary arm 1520 and the clamping aid 1510 can be made of the same material first, and then a material with a higher hardness is added to the outside or inside of the clamping auxiliary arm 1520 as a reinforcing tube or a stiffened wire. To ensure the support of the clamping auxiliary arm 1520 (as shown in Figure 14a).
  • the clamping aid 1510 is at least partially made of a radiopaque X-ray material.
  • the relative position between the instrument and the leaflets cannot be judged by a lower level of operation requirements such as X-rays, and the precise ultrasonic guidance must be relied upon to clamp the components.
  • Ultrasound has high requirements for doctor's operation technology and analysis of cardiac ultrasound images, resulting in increased surgical costs, increased difficulty in surgery, and increased operation time.
  • the clamping aid 1510 is made of a non-transmissive X-ray material. After the clamping aid 1510 is in contact with the leaflets, the flexible and/or elastic clamping aid 1510 is associated with the amplitude of the leaflets. The swinging, therefore, the operator can quickly and accurately determine the position of the leaflets by X-rays before the clamping assembly 1300 holds the leaflets, thereby operating the clamping assembly 1300 more quickly and accurately to clamp the leaflets, reducing the cost of surgery and Difficulty, shorten the operation time and improve the success rate of surgery.
  • the clamping aid 1510 may also be a deformed structure composed of a plurality of support rods. After the deformation structure is contracted and deformed, it is housed in the pusher catheter 1210 together with the clamp auxiliary arm 1520. As shown in FIG. 14b, the deformed structure is an open bifurcated structure or an umbrella structure composed of a plurality of support rods, and the angle between the bifurcated structures is Less than or equal to 150°. In order to facilitate pushing in the pusher catheter 1210, the clamp aid 1510 has a stretched state in a compressed state and a natural state.
  • the clamping assistant 1510 When the clamping assistant 1510 is in the compressed state, it can be received in the auxiliary arm receiving cavity 1250 of the pushing catheter 1210 and pushed; when the clamping aid 1510 is extended from the opening 1260, it is transformed into an extended state and can be supported on the flap.
  • the lower surface of the leaf the stable beating leaflets.
  • the contact surface of the larger diameter clamping aid 1510 and the leaflet is the plane in which the clamping aid 1510 is located. Therefore, the contact area between the clamping aid 1510 and the leaflet is larger, which can be better.
  • the leaflets are fitted to improve the support of the leaflets by the clamping aid assembly 1500.
  • the ends of the bifurcated or umbrella-shaped clamping aids 1510 can be rolled in the proximal direction of the clamping auxiliary arms 1520, and the plurality of clamping aids 1510 form a recessed area. As shown in Figure 14c. At this time, since the ends of each of the gripping aids 1510 are turned inwardly and directed toward the proximal end of the gripping auxiliary arm 1520, the end of the support rod of the gripping aid 1510 can be prevented from stabbing the leaflets or the ventricular wall.
  • the deformed structure may also be a closed loop structure composed of a plurality of support rods, and the closed loop structure may be circular, diamond, elliptical, pear-shaped, A polygon or other shape that is irregular but can form a closed structure.
  • at least one flexible and/or elastic connecting rod 1511 may be disposed between the support rods of the closed-loop structure to improve the stability of the closed-loop structure. The support force of the clamping aid 1510 on the leaflets is further enhanced.
  • the closed loop structure when a plurality of support bars and connecting rods are disposed in the closed loop structure, the closed loop structure may also form a sheet structure or a mesh structure.
  • the mesh structure may be heat-set, the mesh structure is formed into a stretchable deformable disc-like structure, and the disc-shaped structure may be further heat-set to form a columnar shape or a nest shape. , oblate and other structures.
  • the clamping aid 1510 is made of a shape memory material, it can be received in the auxiliary arm receiving cavity 1250 of the push catheter 1210 and pushed, and then extended through the opening 1260 to return to the natural unfolded state, in contact with the lower surface of the leaflet. And provide support for the leaflets.
  • the detection assembly 1600 is configured to detect whether the leaflets are clamped between the distal collet 1310 and the proximal collet 1320.
  • the probe assembly 1600 includes at least one probe 1610. As shown in FIG. 15, in the present embodiment, the detecting assembly 1600 includes two probes 1610 arranged side by side, and the distance between the two probes 1610 and the clamping pusher 1330 is substantially equal.
  • the axial length of the probe 1610 is preferably greater than the minimum length of the push catheter 1210 in the axial direction.
  • the probe 1610 is movably worn in the probe channel 1270 of the push catheter 1210.
  • the proximal end of the probe 1610 is coupled to the probe handle 1601.
  • the clamping face of the proximal collet 1320 is provided with a probe outlet 1321 for facilitating the distal end of the probe 1610 to extend therefrom.
  • the clamping face 1311 of the corresponding distal collet 1310 is provided with a probe receiving cavity 1312 opposite the probe outlet 1321 for receiving the distal end of the probe 1610.
  • a probe receiving cavity 1312 opposite the probe outlet 1321 for receiving the distal end of the probe 1610.
  • the pusher catheter 1210 is provided with a probe channel 1270, a clamp pusher channel 1280, and a puncture pusher channel 1290 in the axial direction.
  • the clamping pusher 1330 is inserted into the clamping pusher channel 1280 of the push catheter 1210, and the piercing pusher 1420 is inserted into the piercing push rod channel 1290 of the push catheter 1210, and the axis of the clamping push rod 1330 and the piercing push rod 1420 is clamped.
  • the orientation is parallel to the axial direction of the pusher catheter 1210.
  • the clamping pusher channel 1280 is disposed on one side of the pusher catheter 1210, and the two piercing pusher channels 1290 are disposed on the other side of the pusher catheter 1210.
  • the probe channel 1270 is disposed between the clamping pusher channel 1280 and the piercing push rod channel 1290, and the distance between the probe channel 1270 and the clamping pusher channel 1280 is less than between the probe channel 1270 and the piercing push rod channel 1290. the distance.
  • the auxiliary arm receiving cavity 1250 is further provided in the pushing catheter 1210, the auxiliary arm receiving cavity 1250 is disposed between the clamping pusher channel 1280 and the piercing push rod channel 1290, and the probe channel 1270 is disposed in the clamping.
  • the distance between the pusher channel 1280 and the auxiliary arm receiving cavity 1250, and the distance between the probe channel 1270 and the clamping pusher channel 1280 is smaller than the distance between the probe channel 1270 and the piercing push rod channel 1290.
  • the distal end of the probe 1610 when the distal end of the probe 1610 is blocked by the leaflet 600 from entering the probe receiving cavity 1312 shown in Figure 10a, it also indicates that the position between the edge of the leaflet 600 and the suture 3000 is relatively fixed.
  • the leaflet 600 if the leaflet 600 is in a poorly gripped state, i.e., the leaflet 600 does not completely cover the probe opening 1321 on the clamping surface of the proximal collet 1320, the distal end of the probe 1610 can After the probe opening 1321 is extended and enters the probe receiving cavity 1312 of the distal collet 1310, the operator needs to re-clamp the leaflet 600. Therefore, in the present embodiment, the probe can effectively detect the clamping effect of the leaflet 600 by the contact state with the leaflet 600.
  • the probe 1610 includes a probe body 1661 having a length and a probe 1662 disposed at the distal end of the probe body 1661, integrally formed or fixedly coupled therebetween.
  • the probe body 1661 can be a solid or hollow structure.
  • the probe body 1661 may have a regular circular or elliptical shape, a crescent shape, a semicircular shape, a polygonal shape, or the like, and is preferably circular.
  • the probe 1662 is a solid structure or a hollow structure whose outer surface is smooth.
  • the shape of the probe 1662 is selected from at least one of a cone shape, a table shape, a column shape, a sphere shape, or a hemisphere shape.
  • Both the probe body 1661 and the probe 1662 may be made of a metal material, a polymer material, or a metal-polymer material.
  • the probe body 1661 may be a solid rod-shaped or hollow tubular structure of a single-layer or multi-layer composite structure, and may also be wound from a single wire or a plurality of wires.
  • the hardness of the distal end portion of the probe body 1661 is less than or equal to the hardness of the proximal end portion of the probe body 1661. That is, the distal end portion of the probe body 1661 preferably has flexibility or elasticity to avoid puncture or damage of the leaflets, and the proximal end portion of the probe body 1661 is preferably a structure having a certain hardness or rigidity to provide support and pushability.
  • the distal end portion and the proximal end portion of the probe main body 1661 may be integrally formed or may be separately processed and joined together by a technical means such as welding, bonding, socket, thread or interference fit, that is, the probe body.
  • the proximal support and distal flexibility of the 1661 can be achieved by making the proximal and distal portions of the probe body 1661 using different materials, respectively. It can be understood that, in other embodiments, the whole rod or tube body may be made of a softer material, and then the outer surface of the proximal end portion of the rod body or the tube body is sheathed with a higher hardness outer tube.
  • the tube is reinforced to increase the proximal support of the probe body 1661; the heat-shrinkable tube may be used as a reinforcing tube wrapped around the softer rod body or the proximal end of the tube body, and then heated to shrink the heat-shrinkable tube and wrapped around the proximal end portion.
  • the outer surface is to increase the proximal support of the probe body 1661.
  • a thermoplastic elastomer such as Pebax or nylon may be wrapped around the outer surface of the rod body or the tubular body and then heated. The thermoplastic elastomer is melted and wrapped around the outer surface while penetrating into the gap between the plurality or individual filaments to increase the proximal support of the probe body 1661.
  • the detection assembly 1600 can include only one probe 1610 or include multiple probes 1610.
  • the plurality of probes 1610 can be commonly worn in a lumen of the push catheter 1210, ie, the push catheter 1210 has only one probe channel 1270, and can also be worn separately in different lumens of the push catheter 1210 (ie, push The catheter 1210 has a plurality of probe channels 1270, as shown in FIG.
  • the suture locking device 2000 includes a suture clasp 2100 for securing the suture 3000, a latch push device 2200 detachably coupled to the suture clasp 2100, and a suture control mechanism.
  • the buckle 2100 secures the suture 3000 and releases the push control 2300 of the suture lock 2100.
  • the suture buckle 2100 includes a latch body 2110 and a locking pin 2120 .
  • the latch body 2110 is provided with an inner cavity 2160 extending through both ends of the latch body 2110 in the axial direction.
  • the locking cavity 2161 is a rectangular parallelepiped cavity.
  • the lumen 2160 includes a locking lumen 2161 at the distal end of the latch body 2110 and a movable lumen 2162 at the proximal end of the latch body 2110.
  • the locking cavity 2161 is in communication with the movable cavity 2162.
  • the inner diameter of the locking cavity 2161 is smaller than the inner diameter of the movable cavity 2162.
  • the locking pin 2120 includes a locking portion 2121 and two sliding portions 2122 disposed at both ends of the locking portion 2121.
  • the locking portion 2121 is received in the inner cavity 2160 of the latch body 2110 and slides in the axial direction of the latch body 2110.
  • Two slits are formed between the two sides of the locking portion 2121 and the inner cavity 2160, and the widths of the two slits are synchronously reduced from the movable cavity 2162 to the locking cavity 2161 in the axial direction; the plurality of sutures 3000 are respectively worn in the In two slits.
  • the suture 3000 can be smoothly pulled.
  • the suture 3000 is clamped in the locking cavity 2161 by the locking portion 2121 and the wall surface of the inner cavity 2160 of the locking body 2110. .
  • the inner cavity 2160 of the latch body 2110 is symmetrical in the axial direction, and the shapes and sizes of the two slits are the same. It can be understood that in other embodiments, the inner cavity 2160 can be asymmetric in the axial direction, and the shapes and sizes of the two slits can be different.
  • the slit asymmetrical suture lock is particularly suitable for locking.
  • the multiple sutures are from a plurality of different lesions, and the number or type of sutures used in each lesion is different.
  • the latch body 2110 is a cylinder which may be in the shape of a cylinder, a prism, or a cylinder having a flat sidewall.
  • the latch body 2110 is a cylinder and includes two opposite and parallel side walls 2140.
  • the two side walls 2140 are respectively provided with an elongated guide groove 2141 along the axial direction of the lock main body 2110.
  • the latch body 2110 needs to remain in the patient's body, so the distal end and the proximal end of the latch body 2110 need to be smoothed.
  • the suture clasp 2100 should be made of a biocompatible material having a certain hardness, and a metal material or a polymer material, preferably a titanium alloy, a nickel titanium alloy or a medical stainless steel, may be used. In this embodiment, a titanium alloy is used.
  • a contact between the locking portion 2121 and the wall surface of the inner cavity 2160 forms a face-to-face, face-to-line contact to clamp the suture.
  • the locking pin 2120 is a cylinder with a flat surface or a flat surface.
  • the locking portion 2121 and the sliding portion 2122 are cylindrical, and the diameter of the locking portion 2121. is larger than the diameter of the sliding portion 2122.
  • the width of the guide groove 2141 is smaller than the diameter of the locking portion 2121 and larger than the diameter of the sliding portion 2122, preventing the locking pin 2120 from coming out of the guide groove 2141.
  • a plurality of sutures 3000 pass through the lumen 2160 of the latch body 2110 and are located on either side of the locking portion 2121 of the locking pin 2120, respectively.
  • the locking pin 2120 is slid by the external force along the guide groove 2141 toward the distal end of the latch body 2110, and the locking portion 2121 can simultaneously press the suture 3000 in the slits on both sides, as shown in Fig. 24c.
  • the locking portion 2121 of the locking pin 2120 reaches the distal end of the guide groove 2141, it cannot continue to advance distally, and the suture 3000 is locked.
  • At least one suture 3000 can be worn on each side of the locking portion 2121 of the locking pin 2120. Since the sutures 3000 are respectively located in the slits on both sides of the locking pin 2120, the suture clasp 2100 of the present embodiment can effectively avoid the suture 3000 and the buckle due to the frictional failure between the plurality of sutures 3000. Sliding between the bodies 2110 is particularly suitable for the case of fixing a plurality of sutures 3000.
  • the proximal end of the guide groove 2141 forms a direction extending in the axial direction of the vertical latch body 2110.
  • the rectangular mounting opening 2143 has a width greater than the diameter of the locking portion 2121 of the locking pin 2120 to facilitate insertion of the locking pin 2120 into the interior 2160 of the latch body 2110.
  • the mounting port 2143 is further provided with a stopping member 2150.
  • the stopping member 2150 at least partially covers the mounting opening 2143.
  • the stopping member 2150 is provided with a receiving opening for receiving the sliding portion 2122 of the locking pin 2120.
  • the width of the receiving opening is smaller than the locking pin 2120.
  • At least one of the outer surface of the locking pin 2120 and the inner surface of the locking cavity 2161 is provided with a friction enhancing layer (not shown).
  • the friction enhancing layer is disposed on the outer surface of the locking portion 2121 of the locking pin 2120 or/and the inner surface of the locking cavity 2161 corresponding to the movement of the locking portion 2121.
  • the friction enhancing layer may be a roughened rough surface or an elastic surface disposed on the outer surface of the locking portion 2121 and the inner surface of the locking cavity 2161, or may be provided with a plurality of small surfaces on the outer surface of the locking portion 2121 and the inner surface of the locking cavity 2161.
  • a protrusion such as a bump or a rib.
  • the proximal end of the latch body 2110 is provided with a connecting portion 2130 for detachable connection with the latch pushing device 2200.
  • the structure of the connecting portion 2130 is various to accommodate different connection modes.
  • the connecting portion 2130 preferably includes a radially disposed S-shaped bayonet.
  • the radially disposed bayonet means that the opening direction of the bayonet is in the radial direction.
  • the latch pushing device 2200 includes a mandrel 2210, a push rod 2220 that is movably sleeved outside the mandrel 2210, and a handle 2230 that is coupled to the proximal end of the push rod 2220.
  • the suture clasp 2100 is received within the distal end of the push rod 2220 and is detachably coupled to the distal end of the mandrel 2210.
  • a push control device 2300 is disposed in the handle 2230 to control the relative movement between the push rod 2220 and the mandrel 2210 such that the suture lock 2100 locks the suture 3000 and is separated from the distal end of the mandrel 2210.
  • the mandrel 2210 is a solid rod-shaped or hollow tubular structure, and the distal end of the mandrel 2210 is detachably coupled to the latch body 2110.
  • the distal end of the mandrel 2210 is provided with a radial S-shaped chuck 2211, and the chuck 2211 is spliced with the connecting portion 2130 of the latch body 2110.
  • the chuck 2211 is spliced with the bayonet of the connecting portion 2130 to form a concave-convex fit, and the axial connection of the suture lock 2100 and the mandrel 2210 is realized under the radial constraint of the push rod 2220, and the radial constraint of the push rod 2220 After the release, the chuck 2211 is separated from the bayonet of the connecting portion 2130.
  • the S-shaped bayonet of the connecting portion 2130 cooperates with the mandrel 2210 of the latch pushing device 2200 to form a seamless radial splicing.
  • the connecting portion 2130 can be provided with an S-shaped chuck, and the distal end of the mandrel 2210 is correspondingly provided with a radial S-shaped bayonet. It can be understood that in other embodiments, the relief structure may be formed by splicing a complementary wave shape, a tooth shape, or the like.
  • the handle 2230 is a hollow structure, and the surface structure of the handle 2230 is suitable for the operator to hold.
  • the mandrel 2210 is non-detachably connected to the proximal end or detachably coupled to the mandrel mount 2212.
  • the mandrel mount 2212 is coupled to the proximal end of the handle 2230.
  • the shape and structure of the mandrel holder 2212 are not limited, and may be any structure capable of connecting the mandrel 2210 and the handle 2230.
  • the distal end of the mandrel fixing member 2212 is provided with a snap block that is engaged with the card slot in the handle 2230.
  • the proximal end of the mandrel mount 2212 is provided with a cylindrical operating portion that can be passed out from the proximal end of the handle 2230.
  • the mandrel holder 2212 is also provided with a gasket made of an elastic material.
  • the push rod 2220 is a hollow tubular structure, the mandrel 2210 is worn in the push rod 2220, and the lock main body 2110 is received in the distal end of the push rod 2220.
  • the opposite sides of the distal end of the push rod 2220 are correspondingly provided with a U-shaped slit 2221 for receiving the sliding portion 2122 of the locking pin 2120.
  • the two sliding portions 2122 are respectively received from the guide groove 2141 and housed in the slit 2221.
  • the push control device 2300 is used to control the relative movement between the push rod 2220 and the mandrel 2210 such that the suture lock 2100 locks and secures the suture 3000 in the buckle body 2110 and drives the suture lock 2100 out of the push.
  • the distal end of the rod 2220 is used to control the relative movement between the push rod 2220 and the mandrel 2210 such that the suture lock 2100 locks and secures the suture 3000 in the buckle body 2110 and drives the suture lock 2100 out of the push.
  • the push control device 2300 includes a push rod fixing member 2222 disposed in the handle 2230, and a limit connecting portion 2320 connected to the distal end of the push rod fixing member 2222.
  • a drive locking mechanism 2310 is mounted on the push rod 2220.
  • the proximal end of the push rod 2220 is fixedly connected to the push rod fixing member 2222 after the proximal end of the self-driving locking mechanism 2310 and the proximal end of the limiting connecting portion 2320.
  • the drive locking mechanism 2310 is threadedly coupled to the limit connection 2320 to axially move the drive locking mechanism 2310 along the handle 2230 to drive axial movement of the push rod 2220 relative to the handle 2230 and the mandrel 2210.
  • the push rod fixture 2222 is worn in the handle 2230.
  • the proximal end of the push rod 2220 is non-detachably connected or detachably connected to the push rod fixing member 2222.
  • the shape and structure of the push rod fixing member 2222 are not limited, and may be any structure capable of fixing the push rod 2220. In this embodiment, a cylindrical structure is employed.
  • the limiting connection portion 2320 is a tubular structure fixed to the outside of the push rod 2220.
  • the distal end of the limiting connecting portion 2320 is provided with an external thread for screwing with the internal thread of the driving locking mechanism 2310.
  • the rotary drive locking mechanism 2310 can drive the limit connection portion 2320 to move axially, thereby driving the push rod 2220 to move axially.
  • the drive locking mechanism 2310 includes a multi-tooth engagement portion 2302 and an appropriate amount of the precession control mechanism 2301 connected to the multi-tooth engagement portion 2302.
  • the multi-tooth engagement portion 2302 has a cylindrical structure, and an inner wall thereof is provided with an internal thread and an external thread provided at a distal end of the limit connection portion 2320.
  • the outer wall of the multi-tooth engaging portion 2302 is provided with a strip of teeth arranged at intervals in the circumferential direction.
  • the appropriate amount of the screw-in control mechanism 2301 includes a hand wheel 2311 that facilitates the rotation operation and a drive connector 2313 that is disposed in the hand wheel 2311 and detachably coupled to the multi-tooth engagement portion 2302.
  • the hand wheel 2311 When the hand wheel 2311 is elastically engaged with the driving connection member 2313, and the rotation force of the hand wheel 2311 exceeds the resistance between the two, the hand wheel 2311 rotates relative to the driving connection member 2313.
  • One embodiment of the elastic engagement between the hand wheel 2311 and the driving connector 2313 is that at least one elastic chuck 2314 is disposed on the inner wall of the hand wheel 2311, and a plurality of spaced cards are evenly disposed on the outer wall of the corresponding driving connector 2313 in the circumferential direction.
  • a card slot 2315 is formed between two adjacent blocks 2316. The elastic chuck 2314 disposed on the inner wall of the hand wheel 2311 is received in the corresponding card slot 2315 and is elastically engaged with the corresponding card block.
  • the inner wall of the hand wheel 2311 is evenly disposed with a plurality of spaced apart blocks 2316 in the circumferential direction, and a card slot 2315 is formed between the adjacent two blocks 2316.
  • At least one elastic chuck 2314 is disposed on the outer wall of the corresponding drive connector 2313. The elastic chuck 2314 provided by the driving connector 2313 is received in the corresponding card slot 2315 and elastically engaged with the corresponding card block 2316.
  • each of the blocks 2316 is provided with a sliding surface 2316a, and the other side of each of the blocks 2316 is provided with a stopping surface 2316b.
  • the end of the elastic chuck 2314 overlaps with the sliding surface 2316a, and the rotation of the hand wheel 2311 drives the driving connector 2313 to rotate.
  • the sliding surface 2316a is a slope provided along the rotation direction of the hand wheel 2311.
  • the end of the elastic chuck 2314 overlaps with the stopping surface 2316b, and the stopping surface 2316b prevents the elastic chuck 2314 from sliding out of the slot 2315, so that the reverse rotation of the hand wheel 2311 drives the driving connecting member 2313 to rotate in the reverse direction.
  • the elastic chuck 2314 and the block 2316 are at least partially made of an elastic material, or may be made of a rigid material having a relatively high toughness. Thus, deformation occurs when a certain external force is applied.
  • the elastic chuck 2314 is a spiral elastic piece or a resiliently bent elastic pawl.
  • the resilient clip 2314 includes an elastic member and a top member disposed at an end of the resilient member.
  • the hand wheel 2311 cannot continue to rotate due to the resistance. If the hand wheel 2311 is continuously rotated, the elastic chuck 2314 is deformed by force. In the wire phenomenon, the threads of the multi-tooth engaging portion 2302 and the limit connecting portion 2320 can no longer be screwed, thereby avoiding excessive rotation and causing the locking body 2110 to be crushed and damaged. Therefore, the appropriate amount of precession control mechanism 2301 can indicate the degree of locking of the suture 3000, preventing the suture 3000 from being locked or the lock body 2110 from being damaged.
  • the sliding phenomenon can also prompt the operator to lock into the state in which the suture 3000 cannot continue to be deformed, and the operator can perform the next operation; if the silking phenomenon does not occur, the suture 3000 has not been completely fixed, and still needs to be Continue to rotate the hand wheel 2311 until the slip occurs.
  • the handle 2230 is provided with a first locking button 2330 and a second locking button 2340.
  • the first locking button 2330 and the second locking button 2340 can perform radial movement. Specifically, at least two limiting ports are opened on the handle 2230, and the first locking button 2330 and the second locking button 2340 are respectively movably mounted in one of the limiting ports.
  • the first locking button 2330 is radially pressed to move in the direction of the mandrel 2210, the end of the first locking button 2330 abuts the proximal end surface of the multi-tooth engaging portion 2302, and the multi-tooth engaging portion 2302 is restricted along the axis.
  • FIG. 30 to FIG. 31 another different embodiment of the suture locking device 2000 is that the position between the push rod 2220 and the handle 2230 remains unchanged, and the push control device 2300 is connected to the mandrel 2210 and then passed.
  • the push control device 2300 drives the mandrel 2210 to move axially distally such that the mandrel 2210 is moved relative to the push rod 2220, thereby reaching the locking pin 2120 of the latch body 2110 to lock the suture 3000, and the mandrel 2210 along Retracting axially proximally causes the distal end of the push rod 2220 to move away from the mandrel 2210.
  • the push control device 2300 includes a mandrel fixing member 2212 disposed in the handle 2230, a limit connecting portion 2320 connected to the distal end of the mandrel fixing member 2212, and a driving locking mechanism 2310 fixed on the mandrel 2210. .
  • the proximal end of the mandrel 2210 is connected to the mandrel fixing member 2212 after the proximal end of the self-driving locking mechanism 2310 and the proximal end of the limiting connecting portion 2320 are bent out, and the driving locking mechanism 2310 is screwed with the limiting connecting portion 2320 so that The drive locking mechanism 2310 moves axially along the handle 2230 to drive axial movement of the mandrel 2210 relative to the handle 2230 and the push rod 2220.
  • the limiting connection portion 2320 is a tubular structure fixed to the outside of the mandrel 2210, and the distal end of the limiting connecting portion 2320 is screwed with the driving locking mechanism 2310.
  • the method for the valve repair of the mitral valve of the heart valve repair system provided by the embodiment is described below, and includes the following steps.
  • suture implant device 1000 is advanced into the left ventricle and the suture implant device 1000 is advanced until the distal collet 1310 and the proximal collet 1320 are both within the left atrium.
  • the distal end of the suture implanting device 1000 is slightly moved until one of the leaflet edges (such as the posterior leaf edge) is in contact with the gripping push rod 1330, and the second handle 1301 is retracted proximally.
  • the distal collet 1310 is driven to move toward the proximal collet 1320 until both are closed and the leaflets are clamped.
  • the needle receiving cavity 1312 at this time, it is necessary to repeat the operation of S2 to S4 to re-clamp the leaflets; when the leaflets are not effectively clamped, the relative distance between the distal collet 1310 and the proximal collet 1320 can be finely adjusted, and then adjusted. Clamping the relative position between the push rod 1330 and the leaflets, operating the clamping assembly 1300 again to clamp the leaflets, and then performing the operation of S5; during the adjustment, due to the clamping aid assembly 1500 under the leaflets The leaves have a certain supporting effect to prevent the leaflets from slipping out of the clamping assembly 1300.
  • the third handle 1401 is retracted, so that the puncture needle 1410 drives the fixing member 3010 of the suture 3000 and the suture 3000 connected to the fixing member 3010 through the leaflets in sequence, and the anti-slip member 3020 is also taken from the distal end.
  • the gripping surface 1311 of the collet 1310 is pulled out, and the abutting surface 3022 (ie, the lower surface) of the cleat 3020 is in contact with the upper surface of the leaflet 600, while a portion of the suture 3000 is pressed against the upper surface of the cleat 3020.
  • the flaps 600 are attached (as shown in FIG. 38). At this time, the point contact between the suture 3000 and the leaflets is converted into a surface contact between the cleat 3020 and the leaflets 600, which can effectively reduce the leaflets 600. The risk of tearing.
  • S9 Repeat the operation of S1 to S8, implant the suture 3000 on the other side leaflet of the mitral valve (such as the anterior leaf), and then insert a plurality of sutures 3000 on the side leaflets into the suture lock outside the patient's body.
  • the sutures 3000 of the two leaflets are respectively inserted into the two slits of the latch body 2110 when worn.
  • the sliding portion 2122 is moved distally relative to the locking body 2110 along the guiding groove 2141, and continues to press the suture 3000 until the locking pin 2120 cannot continue to move distally, at which time the plurality of sutures 3000 are securely fixed at Suture lock 2100.
  • the suture 3000 after the suture 3000 is adjusted to a suitable length, the excess suture 3000 can be not cut, but the ends of all the sutures 3000 can be directly fixed to the apex, the papillary muscle or the ventricular wall. On, complete the "chossy repair" of the valve.
  • the fixation can be completed by a conventional gasket or patch, or can be completed by the suture fastening device 2000, specifically, the end of the suture 3000 is pierced from the heart incision and worn.
  • suture lock 2100 of the suture lock device 2000 the mandrel 2210 and the push rod 2220 are pushed distally until they reach the vicinity of the outer surface of the heart, and then the suture 3000 is locked, and then the excess suture 3000 is cut.
  • a suture clasp 2100 is within the heart, and the two leaflets form a "double-pored structure" under the leaflets, and another suture clasp 2100 remains on the outer surface of the heart to secure the end of the suture 3000.
  • the heart valve repair system of the present invention may also implant the suture 3000 into one or both of the leaflets of the heart valve by the suture implant device 1000, and then fix the end of the suture 3000 to the apex, On the papillary muscle or ventricular wall, suture line 3000 is used as artificial chordae to complete the "chossy repair" of the valve.
  • the fixing can be completed by a conventional gasket or patch, or by the suture fastening device 2000, and will not be described herein.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)
  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un système de réparation de valvule cardiaque, comprenant au moins une suture (3000), un dispositif d'implantation de suture (1000) utilisé pour implanter la suture (3000) dans un lobe d'une valvule cardiaque, et un dispositif de blocage de suture (2000) pour fixer la suture (3000). Le dispositif d'implantation de suture (1000) comprend un cathéter de poussée (1210), un ensemble de serrage (1300) utilisé pour serrer un lobe, et un ensemble de perforation (1400) utilisé pour percer un lobe. Le dispositif de blocage de suture (2000) comprend un blocage de suture (2100) utilisé pour fixer une pluralité de sutures (3000), un dispositif de poussée de blocage (2200) qui est relié de manière détachable au blocage de suture (2100), et un dispositif de commande de poussée (2300) utilisé pour fixer et libérer le blocage de suture (2100). Le système de réparation de valvule cardiaque implante une pluralité de sutures (3000) dans les lobes antérieur et postérieur de la valvule mitrale à l'aide du dispositif d'implantation de suture (1000), et la pluralité des sutures (3000) sont fixées ensemble à l'aide du dispositif de blocage de suture (2000) afin de réduire ou d'éliminer un espace entre la valvule mitrale de sorte que la valvule mitrale est présentée en formation à double trou. La structure est simple, les coûts de fonctionnement sont faibles, et le degré de traumatisme pour un patient est faible.
PCT/CN2019/076509 2018-03-28 2019-02-28 Système de réparation de valvule cardiaque et son dispositif de blocage de suture WO2019184649A1 (fr)

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CN201810266392.4A CN110313947A (zh) 2018-03-28 2018-03-28 心脏瓣膜修复系统

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CN111904663A (zh) * 2020-08-18 2020-11-10 上海竑宇医疗科技有限公司 一种环缩器及其安装方法
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