CN209153791U - Heart valve repair system - Google Patents

Abstract

The utility model discloses a kind of Heart valve repair system, suture implanted device including at least two sutures, for suture to be implanted into valvular different leaflets respectively and the suture lock knot device that at least two sutures are fixed together；Suture implanted device includes push conduit, the clamp assemblies for clamping leaflet and the piercing assembly for puncturing leaflet；Suture lock knot device includes the push control device for latching the lock driving means being detachably connected between suture lock for fixing the suture of more sutures and latching fixed suture for controlling suture and discharge.The utility model is first implanted into more sutures in mitral frontal lobe and rear leaf respectively, more sutures are fixed together again, reduce or eliminate the gap among bicuspid valve, make bicuspid valve that diplopore be presented, to treat mitral reflux, surgical procedure is simple, operation is at low cost, patient trauma's degree is low, complication risk is low, recovery process is very fast.

Description

Heart valve repair system

Technical field

The utility model belongs to the field of medical instrument technology, is related to a kind of Heart valve repair system.

Background technique

Bicuspid valve is unidirectional " valve " between atrium sinistrum (referred to as: LA) and left ventricle (referred to as: LV), it is ensured that blood Left ventricle is flowed to from atrium sinistrum.Mitral leaflet is divided into frontal lobe and rear leaf, and when left ventricle is in diastole state, the two, which is in, opens Open state, blood flow to left ventricle from atrium sinistrum；When left ventricle is in contraction state, chordae tendineae is stretched, and guarantees that leaflet will not be by Blood flow is flushed to atrial side.Fig. 1 a-1b shows the bicuspid valve of normal health, and forward and backward leaf closure is good, to guarantee blood from a left side Ventricle flows to aorta by aorta petal (referred to as: AV).There is lesion in bicuspid valve shown in Fig. 2 a-2b, when left ventricle is in When contraction state, bicuspid valve cannot be as restoring when normal condition to closed state, and it is de- that the impulse force of blood flow can further result in leaflet Enter atrium sinistrum, causes blood reflux.

Surgical operation implant sewing line is generallyd use as the mode or valve edge of artificial cords to edge suture at present Equal operations in treating mitral reflux, this kind of operation is both needed to using invasive Thoracotomy, and carries out general anesthesia, moderate hypothermia body Outer circulation is used as auxiliary to support, therefore there are surgical procedure complexity, perform the operation at high cost, patient trauma degree height, complication risk The defects of height, painful hospital stays length and patient's recovery process.There are also a kind of two points of Cardiac catheterization in the prior art The method that valve backflows, is the repair mode using edge to edge, and first transatrial septal puncture is sent into two points to the bicuspid valve position of lesion Valve clamp, the edge for reclamping two leaflets form " diplopore " bicuspid valve.The method of this interventional therapy is needed in patient's body Interior to be sent into bicuspid valve clamp by complicated tortuous path, can not intuitively observe position of the bicuspid valve clamp in patient's heart is It is no rationally, and operator can only remotely operate in vitro bicuspid valve clamp clamping leaflet and release process, therefore operating time compared with Long, success rate is lower.

Utility model content

The technical problem to be solved by the present invention is in view of the above-mentioned drawbacks in the prior art, provide a kind of heart The repair system of valve, suitable for the valve repair through apex of the heart path treatment mitral reflux.The valve of the utility model Repair system is first implanted into more sutures in mitral frontal lobe and rear leaf respectively, then more sutures are fixed together, with Mitral frontal lobe and rear leaf are pulled towards each other, the gap among bicuspid valve is reduced or eliminate, makes bicuspid valve that diplopore be presented, To treat mitral reflux, surgical procedure is simple, operation is at low cost, patient trauma's degree is low, complication risk is low, recovery process Comparatively fast.

The technical scheme adopted by the utility model to solve the technical problem is as follows:

A kind of Heart valve repair system has the suture of certain axial length, for that will suture including at least two The seam that line is implanted into the suture implanted device of valvular different leaflets respectively and at least two sutures are fixed together Zygonema lock knot device.Suture implanted device includes pushing conduit, the clamp assemblies for clamping leaflet and for puncturing leaflet Piercing assembly, clamp assemblies and piercing assembly be actively arranged in push conduit, and suture is placed in clamp assemblies.Seam Zygonema lock knot device includes being detachably connected between suture lock and suture lock for fixed at least two sutures Lock driving means and the push control device that latches fixed suture for controlling suture and discharge.

Further, in the Heart valve repair system, preferably clamp assemblies include that the clamping of receiving suture pushes away The distal end of clamping push rod is arranged in bar and the distal end collet and proximal end collet of opposite folding, distal end collet, and collet setting in proximal end exists Push the distal end of conduit.

Further, in the Heart valve repair system, preferably edge is axially arranged with suture channel in clamping push rod, The suture accommodating chamber penetrated through to the clamping face of distal end collet, suture channel and suture accommodating chamber phase are equipped in the collet of distal end Connection, suture are contained in suture channel and suture accommodating chamber.

Further, it in the Heart valve repair system, is preferably arranged on suture and slides axially along suture Non-slip material.

Further, in the Heart valve repair system, the clamping face of preferably distal end collet is offered for accommodating The Non-slip material container of Non-slip material, radial communication between Non-slip material container and suture accommodating chamber.

Further, in the Heart valve repair system, at least one end preferably in the both ends of suture is connected with Fixing piece, it is non-dismountable between fixing piece and piercing assembly to be fixedly connected with or be detachably fixed connection.

Further, in the Heart valve repair system, the clamping face of preferably distal end collet is offered for accommodating The lock chamber of fixing piece is axially connected between lock chamber and suture accommodating chamber, radial between lock chamber and Non-slip material container Connection.

Further, in the Heart valve repair system, preferably the shape of lock chamber and the shape of fixing piece match It closes, and the inscribe diameter of a circle of lock chamber is greater than the external diameter of a circle of suture accommodating chamber.

Further, in the Heart valve repair system, preferably suture implanted device further includes clamping assisted group Part.Clamping accessory part includes that at least one is actively threaded onto the clamping sub-arm pushed in conduit and is set to clamping sub-arm The clamping auxiliary member of distal end.Clamping auxiliary member is made of elasticity and/or flexible material.Clamp sub-arm push clamping auxiliary member from Push distal end of catheter or proximal end collet side are pierced by.

Further, in the Heart valve repair system, preferably clamping auxiliary member is at least partly by not transmission X-ray Material is made.

Further, in the Heart valve repair system, preferably clamping auxiliary member is by least one support rod structure At rod-like structure, perhaps clamp auxiliary member be the distressed structure being made of more support rods or clamping auxiliary member for The sacculus of flat horizontal surface.

Further, in the Heart valve repair system, preferably piercing assembly include at least one puncture push rod and Set on the piercing needle for puncturing push rod distal end.The distal end of piercing needle is the straight tip of taper.Between piercing needle and fixing piece It is detachable or non-dismountable be fixedly connected.

Further, in the Heart valve repair system, preferably suture implanted device further includes probe assembly, is visited Surveying component includes at least one probe, is installed on to probe activity proximal end collet and distal end collet in push conduit and is respectively equipped with phase Corresponding probe outlet and probe accommodating chamber.The distal end of probe is contained in probe accommodating chamber from probe outlet stretching.

Further, in the Heart valve repair system, preferably the axial length of probe is greater than push conduit along axis To minimum length.

Further, in the Heart valve repair system, preferably probe includes the probe body with certain length And the probe set on probe body distal end.Probe body is solid construction or hollow structure, is popped one's head in as the reality of smooth outer surface Core structure or hollow structure.

Further, in the Heart valve repair system, preferably suture lock includes lock main body and locking pin. Latch main body be equipped with axially through the inner cavity for installing suture, inner cavity include positioned at lock body distal end part latch well, And the movable chamber extended from latch well to lock proximal, the internal diameter of latch well are less than the internal diameter of the movable chamber.Locking pin Including sticking department and in the sliding part of sticking department two sides setting, sticking department is limited in the inner cavity of lock main body and in lock main body Axis move upwards, between the two sides of sticking department and the surface of inner cavity formed two slits, the width of two slits is in the axial direction It is synchronous from movable chamber to latch well to reduce.More sutures are installed on respectively in two slits, more when sticking department is located at movable chamber The smooth pulling of root suture, when sticking department slides into latch well, suture is locked portion and the surface of latch well and clamps.

Further, in the Heart valve repair system, preferably the side wall surface of lock main body is opposite in the axial direction is set It is equipped with the first guide groove and the second guide groove penetrated through respectively to inner cavity, two sliding parts of locking pin are respectively from the first guide groove and second It is pierced by guide groove and slides axially along the first guide groove and the second guide groove.

Further, in the Heart valve repair system, preferably lock proximal is equipped with for pushing with lock The connected interconnecting piece in the distal end of device.

Further, in the Heart valve repair system, preferably lock driving means includes mandrel, is actively arranged Push rod in mandrel exterior and the handle that is connected with push rod proximal end, suture lock are housed in push rod distal end and remote with mandrel It is detachably connected between end.Control device is pushed to be arranged in the handle to control the relative motion between push rod and mandrel.

Further, in the Heart valve repair system, preferably push control device includes pushing away in handle Bar fixing piece, the limit interconnecting piece being connected with push rod fixing piece distal end and the driving retaining mechanism being fixed on push rod, push rod Proximal end is connect after being pierced by from driving retaining mechanism proximal end and limit interconnecting piece proximal end with push rod fixing piece, driving retaining mechanism and limit It is spirally connected between the interconnecting piece of position so that driving retaining mechanism to be axially moved along handle, so that driving push rod is relative to handle and mandrel Axial movement；Or push control device includes mandrel fixing piece, limit interconnecting piece and the driving locking being fixed on mandrel Mechanism, the proximal end of mandrel connect with mandrel fixing piece after being pierced by from driving retaining mechanism proximal end and limit interconnecting piece proximal end, drive It is spirally connected between retaining mechanism and limit interconnecting piece so that driving retaining mechanism to be axially moved along handle, to drive mandrel opposite In the axial movement of handle and push rod.

Further, in the Heart valve repair system, preferably driving retaining mechanism include multiple tooth holding section and with The connected appropriate precession control mechanism in multiple tooth holding section.

Further, in the Heart valve repair system, preferably appropriate precession control mechanism includes handwheel, is set to hand The drive connection part of connection is detachably fixed in wheel and between multiple tooth holding section and between handwheel and drive connection part Appropriate retainer, appropriate retainer are at least partly made of elastic material or toughness material.Appropriate retainer and drive connection part Between be fixedly connected, and the flexible clamping between handwheel, when the rotatory force of handwheel exceeds snapping resistance, handwheel relative to it is appropriate only Slide.The stress skidded off is deformed when handwheel drives the driving force of drive connection part rotation to be less than appropriate retainer, makes to go smoothly Wheel drives drive connection part to rotate to a direction by appropriate retainer；Handwheel drives the driving force of drive connection part rotation to make Appropriate retainer deformation when skidding off, handwheel rotates alone relative to drive connection part.

Further, in the Heart valve repair system, preferably appropriate retainer include on handwheel inner wall or At least one elastic chuck being arranged on drive connection part outer wall is set on corresponding drive connection part outer wall or on handwheel inner wall There are multiple card slots to cooperate with elastic chuck, when the rotatory force of handwheel exceeds snapping resistance, elastic chuck is skidded off from card slot.

Further, in the Heart valve repair system, the side wall of preferably each card slot is equipped with sliding surface.Elastic card After head is caught in card slot, the end of elastic chuck and sliding surface are overlapped, and handwheel rotation drives drive connection part rotation, hand wheel rotating power When snapping resistance beyond sliding surface and elastic chuck, elastic chuck is skidded off from card slot；Each card slot is additionally provided with and sliding surface The motion-stopping surface being oppositely arranged, the end of elastic chuck and motion-stopping surface are overlapped to prevent elastic chuck from skidding off card slot, so that handwheel is anti- Drive connection part is driven to rotate backward to rotation.As a result, when drive connection part is by rotational resistance stop, handwheel rotation is forced Elastic chuck occurs flexible deformation and skids off card slot by sliding surface, and handwheel rotates alone relative to drive connection part.

Further, in the Heart valve repair system, preferably handle, which is equipped with, can distinguish the first of radial motion Locking press button and the second locking press button.When first locking press button is mobile to mandrel direction, the close of multiple tooth holding section is supported in end End face is to limit multiple tooth holding section along axial proximal movement.When the movement of mandrel direction is pressed in second locking, end is supported in institute State the rotation that multiple tooth holding section is limited between two teeth of multiple tooth holding section.

The Heart valve repair system of the utility model compared with prior art, at least has the advantages that

The utility model is suitable for the valve repair through apex of the heart path treatment mitral reflux, can fast implement two points The chordae tendineae reparation of valve valve or edge are to edge reparation.In use, first the apex of the heart through patient punctures, the distal end of clamp assemblies is pierced into Patient's heart drives the folding of clamp assemblies to clamp leaflet, then pushes piercing assembly to pierce through leaflet and and suture ends Fixing piece combine, drop back piercing assembly, suture can be driven to drop back, then the end of suture can be fixed on ventricle wall Or on papillary muscle, using suture as artificial cords, realize " chordae tendineae reparation "；Or according to same steps respectively mitral Frontal lobe and rear leaf implant sewing line, withdraw from suture implanted device, and suture is locked knot device and is protruded into patient's heart, driving seam More sutures are fixed together by zygonema lock, so that mitral frontal lobe and rear leaf are pulled towards each other, realize that " edge repairs edge It is multiple ", reduce or eliminate the gap between leaflet, so that diplopore is presented in the bicuspid valve after repairing.Therefore, the utility model Heart valve repair system can treat it is mitral it is organic backflow and functionality backflows, entire surgical procedure is only in patient's chest The preceding lesser wound of formation, it is minimally invasive, avoid damage of the traditional thoracotomy to patient；And instrument is easily operated, avoids existing Have technology repairs mitral tedious steps through conduit, and success rate of operation is higher, time-consuming shorter.

Detailed description of the invention

Below in conjunction with accompanying drawings and embodiments, the utility model is described in further detail, in attached drawing:

Fig. 1 a to Fig. 1 b is normally closed mitral schematic diagram in heart；

Fig. 2 a to Fig. 2 b is cannot normally closed mitral schematic diagram in heart；

Fig. 3 is the structural schematic diagram of the Heart valve repair system of the utility model；

Fig. 4 is the structural schematic diagram of the suture in Fig. 3；

Fig. 5 a to Fig. 5 c is the structural schematic diagram of the different embodiments of suture；

Fig. 6 is the structural schematic diagram of the suture implanted device in Fig. 3；

Fig. 7 is the explosive view of the suture implanted device of Fig. 6；

Fig. 8 is the structural schematic diagram in the suture implanted device of Fig. 6, when clamp assemblies separate；

Fig. 9 is the knot that the piercing needle of piercing assembly is connected with the fixing piece of suture in the suture implanted device of Fig. 6 Structure schematic diagram；

Figure 10 a is the structural schematic diagram of proximal end collet in the suture implanted device of Fig. 6；

Figure 10 b is the B-B cross-sectional view of Figure 10 a；

Figure 11 a to Figure 11 b is the structure that the different embodiments of accessory part are clamped in the suture implanted device of Fig. 6 Schematic diagram；

Figure 12 is to push distal end of catheter axial direction cross-sectional view in the suture implanted device of Fig. 6；

Figure 13 a and Figure 13 b are the structural schematic diagrams that clamping accessory part and clamping accessory part are supported on leaflet lower surface；

Figure 14 a- Figure 14 g is the structural schematic diagram for clamping the different embodiments of accessory part；

Figure 15 is the structural schematic diagram of probe assembly in the suture implanted device of Fig. 6；

Figure 16 is the structural schematic diagram that the probe assembly in Figure 15 is installed in push conduit；

Figure 17 is the radial cross-section for pushing conduit；

Figure 18 a to Figure 18 c is the detection process schematic diagram of probe assembly；

Figure 19 a to Figure 19 c is the structural schematic diagram of the another embodiment of probe assembly；

Figure 20 is the detection process schematic diagram of the probe assembly of Figure 19；

Figure 21 is the structural schematic diagram of the suture lock knot device in Fig. 3；

Figure 22 is the explosive view of the suture lock knot device of Figure 21；

Figure 23 a to Figure 23 c is the structural schematic diagram of the lock and suture lock knot device cooperation in Figure 21；

Figure 24 a and Figure 24 b are the structural schematic diagrams of the lock in Figure 21；

Figure 25 a to Figure 25 c is locked out pin in the cross-sectional view of the different location axial direction of lock main body；

Figure 26 a to Figure 26 c is the process schematic latched for fixing suture；

Figure 27 is the schematic diagram latched for fixing more sutures；

Figure 28 is the structural schematic diagram of suture lock knot device；

Figure 29 is partial enlarged view at I in Figure 28；

Figure 30 is the structural schematic diagram of appropriate precession control mechanism；

Figure 31 is the structural schematic diagram of drive connection part；

Figure 32 is the surface structure schematic diagram of suture lock knot device another embodiment；

Figure 33 is the partial enlarged view of suture lock knot device；

Figure 34 to Figure 45 is that the process for repairing mitral valve using the Heart valve repair system of the utility model is illustrated Figure.

Specific embodiment

For a clearer understanding of the technical features, objectives and effects of the utility model, now control attached drawing is detailed Illustrate specific embodiment of the present utility model.

Bearing definition: the bearing definition that will be close to operator below is proximal end, and the bearing definition far from operator is distal end.

Embodiment one

As shown in Fig. 3-Figure 33, a kind of Heart valve repair system, the seam including at least two with certain axial length Zygonema 3000, suture implanted device 1000 and general for suture 3000 to be implanted into valvular different leaflets respectively The suture lock knot device 2000 that more sutures 3000 are fixed together.Suture implanted device 1000 includes push conduit 1210, the piercing assembly 1400 for clamping the clamp assemblies 1300 of leaflet and for puncturing leaflet.It clamp assemblies 1300 and wears Thorn component 1400 is actively arranged in push conduit 1210.Suture 3000 is placed in clamp assemblies 1300.Suture lock Knot device 2000 includes removable between the suture lock 2100 of more sutures 3000 and suture lock 2100 for fixing Unload the lock driving means 2200 of connection, and the push control for controlling the fixed suture 3000 of suture lock 2100 and discharging Device 2300 processed.

As shown in Fig. 4, Fig. 9 and Fig. 5 a- Fig. 5 c, the Heart valve repair system of the present embodiment includes at least two sutures 3000.Suture 3000 has certain axial length, and has flexibility.At least one end in 3000 both ends of suture is connected with solid Determine part 3010, it is non-dismountable between fixing piece 3010 and piercing assembly 1400 to be fixedly connected with or be detachably fixed connection.This implementation (as shown in Figure 4) is all arranged at the both ends of suture 3000 in preferred fixing piece 3010 in example.

In more sutures 3000, a part of every suture 3000 is fixed in leaflet, and all sutures 3000 are Knot device 2000 is locked by suture to be fixed together, and multiple leaflets of valve are pulled towards each other.Suture 3000 has soft Property refers to that it can arbitrarily be bent in axial tensionless winkler foundation.Suture 3000 can by biocompatibility high molecular material or compared with It is made of soft metal material, preferably the high molecular materials such as PTFE, PP.EPTFE material is used in the present embodiment.

As shown in figure 4, fixing piece 3010 can be set at the both ends of suture 3000, can also as shown in Fig. 5 a- Fig. 5 c, It is provided only on one end of suture 3000.When operator operates suture implanted device 1000 every time, can be implanted into two or More sutures 3000 can also only be implanted into a suture 3000 every time.It is fixed between suture 3000 and fixing piece 3010 Connection, the mode being fixedly connected can be knotting, winding, welding, bonding, clamping etc..For example, can be by the one of suture 3000 End is formed by knots tied the ball of string being relatively large in diameter after being pierced by fixing piece 3010；Or end is welded as one and is relatively large in diameter Ball；Or the locating rod of one transverse direction is set again in end.When fixing piece 3010 is provided only on one end of suture 3000, Since the other end of suture 3000 is not provided with fixing piece 3010, the other end is as shown in Figure 5 b, should be by knotting, twining Around or setting bulbous end, the modes such as plate-like end so that the diameter of the other end is greater than the diameter of suture 3000, will When this suture 3000 is implanted into leaflet, quilt after one end of suture 3000 is combined by fixing piece 3010 with piercing assembly 1400 Recession, the other end of suture 3000 being relatively large in diameter are fixed on the upper surface of leaflet.

Fixing piece 3010 be used for piercing assembly 1400 formation be detachably fixed connect or it is non-dismountable be fixedly connected, shape Shape cooperates different connection types.The outside of fixing piece 3010 is usually cylindricality, cross-sectional shape can be round, ellipse, The various shapes such as polygon, circular or ellipse.

In order to be increased to face contact for the point contact between suture 3000 and leaflet, torn to reduce suture 3000 The risk of rip-panel leaf is preferably arranged with Non-slip material 3020 on suture 3000, and Non-slip material 3020 can be along 3000 axis of suture To sliding.Since Non-slip material 3020 is set in advance on suture 3000, in the piercing needle of suture implanted device 1000 After 1410 puncture leaflets and connect with the fixing piece 3010 of 3000 end of suture, Non-slip material 3020 can be driven to point of puncture, And it is fixed in leaflet together with suture 3000.Through-hole 3021 is set on Non-slip material 3020, and suture 3000 passes through through-hole 3021.The setting quantity of through-hole 3021 is related with the fixed form of Non-slip material 3020.A kind of mode is arranged on Non-slip material 3020 At least two through-holes 3021, the both ends of a suture 3000 are each passed through after different through-holes 3021 and a fixing piece 3010 It is connected (as shown in Figure 4).Another way is one through-hole 3021 of setting on Non-slip material 3020, and one end of suture 3000 passes through It is connected after the through-hole 3021 with fixing piece 3010 (as shown in Fig. 5 a and Fig. 5 b).Non-slip material 3020 is from suture 3000 in order to prevent On fall off, the diameter of through-hole 3021 is less than the diameter of fixing piece 3010, and suture 3000 is not provided with fixing piece 3010 The other end should be by knotting or being arranged the modes such as bulbous end, plate-like end, so that the diameter of the other end is greater than Non-slip material The diameter (as shown in Figure 5 b) of through-hole 3021 on 3020.

In order to which active force of the suture 3000 to leaflet is dispersed to the contact surface between Non-slip material 3020 and leaflet as far as possible, The needs of Non-slip material 3020 are bonded as far as possible with leaflet, therefore Non-slip material 3020 is equipped with the binding face 3022 being bonded with leaflet.In addition to patch Outside conjunction face 3022,3020 specific structure of Non-slip material is not construed as limiting, such as can be sheet, plate-like or ball with certain area Shape, even irregular shape, preferably sheet.Non-slip material 3020 can be non-porous structure, be also possible to reticular structure, grid Shape structure etc..Non-slip material 3020 should be made of biocompatible materials, can be made of elastic material, can also be by non-resilient material Material is made.Specifically, Non-slip material 3020 is selected from elastomeric pad, cardiac patch, felt piece, network, disk-like structure or double At least one of disk-like structure.The structure of Non-slip material 3020 wherein with disk-like structure or double disk-like structures is similar to existing There is the plugging device in technology, details are not described herein.Preferably, in order to reduce the overall dimensions of instrument, have disk-like structure or The Non-slip material 3020 of double disk-like structures should be made of shape-memory material.Using woven dacron gasket as Non-slip material in the present embodiment 3020。

Suture implanted device 1000 is used to for more sutures 3000 being implanted into the leaflet of valve.As shown in Figure 6 to 8, Suture implanted device 1000 includes clamp assemblies 1300, piercing assembly 1400 and push conduit 1210.Pushing conduit 1210 is Tubular body with certain axial length or the rhabodoid with inner cavity.Push conduit 1210 can use integrally formed more Outer tube and inner tube suit can also be fixed together, form integrally-built push conduit 1210 by lumen.Push conduit 1210 It can be using the high molecular material of biocompatibility (for example, polyformaldehyde POM, polythene PE, nylon PA, polyvinylchloride, third Alkene nitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU), metal material is (for example, stainless steel Either Nitinol) or metal-polymer composite be made.In the present embodiment, push conduit 1210 is axially disposed The rhabodoid of the inner cavity of multiple mutually separated perforations.The proximal end for pushing conduit 1210 is equipped with first handle 1201, for manipulating Push conduit 1210 is withdrawn to distal end push or proximally.

Referring again to Fig. 7, pushes in an inner cavity of conduit 1210 and actively install piercing assembly 1400.Piercing assembly 1400 include puncturing push rod 1420 and set on the piercing needle 1410 for puncturing 1420 distal end of push rod.Puncture push rod 1420 quantity with The quantity of fixing piece 3010 is related.In the present embodiment, referring to fig. 4,3000 both ends of suture are equipped with fixing piece 3010, therefore push away It send and installs two root puncture push rods 1420 in conduit 1210 side by side, two piercing needles 1410 respectively correspond a fixing piece 3010.Piercing needle 1410 can be connect after puncturing leaflet with the fixing piece 3010 of suture 3000, and recession punctures push rod 1420 Suture 3000 can be pulled to proximal end.The distal end of piercing needle 1410 is the straight tip of taper, in favor of puncturing leaflet and reducing Its puncture spot diameter formed in leaflet.Leaflet is passed through using the syringe needle with hook-shaped head end in the prior art, and hooks and takes seam Zygonema 3000, syringe needle of then dropping back drive suture 3000 to pass through leaflet, this shape in leaflet of the syringe needle with hook-shaped head end At point of puncture it is bigger than normal, to leaflet damage it is larger, not only influence patient's post-operative recovery process, also will increase postoperative leaflet and torn The risk split.And the point of puncture that the straight tip of taper is formed in leaflet is small, conducive to the postoperation recovery of patient.The seam of the present embodiment The diameter range for the single point of puncture that zygonema implanted device 1000 is formed in every leaflet is 0.3mm to 1.5mm, further Ground, by selecting the shape and diameter of suitable piercing needle 1410, the controlled diameter of point of puncture is made as about 0.7mm.

Between piercing needle 1410 and fixing piece 3010 it is detachable or it is non-dismountable be fixed together, connection type has It is a variety of, for example, be threadedly coupled, bonding, by rough surface frictional connection, be interference fitted or snap connection.It is adopted in the present embodiment With snapping connection, the protrusion being arranged on groove or hole, with piercing needle 1410 is specifically set in the inner surface of fixing piece 3010 Or convex edge clamping.As shown in figure 9, groove 3125 there are three being set in the inner surface radial direction of fixing piece 3010, with piercing needle 1410 On convex edge 1411 between cooperate clamping.Three grooves 3125 both can guarantee and connect between fixing piece 3010 and piercing needle 1410 Stability, reduce the shaking amplitude of piercing needle 1410 after connection, the diameter that will not additionally increase piercing needle 1410 leads It causes to puncture spot diameter increase.

Referring to Fig. 7,1410 proximal end of piercing needle, which is connected with, punctures push rod 1420, and puncture push rod 1420, which is actively installed on, to be pushed away In the inner cavity for sending conduit 1210.Puncture push rod 1420 proximal end from push 1210 proximal end of conduit be pierced by and with 1401 phase of third handle Even.The axial movement for passing through third handle 1401 as a result, can drive the axial shifting for puncturing push rod 1420 along push conduit 1210 It is dynamic, and then piercing needle 1410 is driven to puncture to distal end or proximally withdraw.After leaflet is clamped the clamping of component 1300, wear Pricker head 1410 can pierce through leaflet and connect with the fixing piece of suture 3,000 3010 under the driving of third handle 1401.It is existing The hook-shaped syringe needle hook of technology takes the probability of suture 3000 relatively low, causes success rate of operation relatively low, extends operating time；And After syringe needle catches on suture 3000, due to only being connected by faint frictional force between syringe needle and suture 3000, dropping back During syringe needle, since blood stream of patients washes away or the movement of operator, it may cause suture 3000 and taken off from syringe needle It falls, causes operative failure.And the fixing piece 3010 of the piercing needle 1410 of the present embodiment and suture 3000 formed it is reliable and stable Connection, and suture 3000 is not easy to be detached from fixing piece 3010, and operator can be conveniently and efficiently by suture 3000 and fixed The connected one or both ends recession of part 3010.

Referring to Fig. 6 to Fig. 8, clamp assemblies 1300 include clamping push rod 1330 for accommodating suture 3000 and opposite open It closes to clamp the distal end collet 1310 and proximal end collet 1320 of leaflet.Clamping push rod 1330 is actively installed on push conduit 1210 In.The distal end of clamping push rod 1330 is arranged in distal end collet 1310, and the distal end of push conduit 1210 is arranged in proximal end collet 1320. The proximal end for clamping proximal end from the push conduit 1210 of push rod 1330 is pierced by and second handle 1301 is arranged.Distal end collet 1310 and close The opposite folding of end collet 1320, which refers to, can push second handle to distal end with relative motion to open or be closed therebetween 1301, drive clamping push rod 1330 mobile to distal end, so that distal end collet 1310 is formed far from proximal end collet 1320 such as Fig. 8 institute The open configuration shown forms leaflet accommodation space between distal end collet 1310 and proximal end collet 1320 at this time, when leaflet enters After leaflet accommodation space, second handle 1301 is proximally withdrawn, so that proximally collet 1320 is close for distal end collet 1310, is formed Clamp position as shown in FIG. 6.It clamps and fixes at this point, leaflet is clamped component 1300.Proximal end collet 1320 and distal end collet 1310 shape should be consistent with the shape cooperation of push conduit 1210, and distal end collet 1310 and proximal end collet 1320 are answered after closure The entirety of smooth in appearance is formed, in order to push and mitigate the damage to patient wound.It is understood that above-mentioned to distal end Push second handle 1301 makes distal end collet 1310 far from the state of proximal end collet 1320, can also be by proximally withdrawing the One handle 1201 and push conduit 1210 reach；Proximally recession second handle 1301 makes distal end collet 1310 close to proximal end The state of collet 1320, can also be by reaching to distal end push first handle 1201 and push conduit 1210.

It will also be appreciated that in other embodiments, the proximal end collet 1320 being separately provided can be cancelled, but directly Using the distal end for pushing conduit 1210 as proximal end collet 1320, cooperate with distal end collet 1310 to clamp leaflet.In this implementation In mode, push conduit 1210 is preferably with multiple rhabodoids for separating inner cavity, using the distal surface of rhabodoid as leaflet Clamping face.

In order to improve the stability of clamping, the clamping face (that is, distal surface of proximal end collet 1320) of proximal end collet 1320 It should be bonded to each other with the clamping face (that is, proximal end face of distal end collet 1310) of distal end collet 1310, for clamping leaflet, and The clamping face of proximal end collet 1320 and the clamping face of distal end collet 1310 are respectively provided with biggish leaflet contact area, such as the two It can be obliquely installed respectively, i.e., it is axial at the acute angle less than 90 degree with push conduit 1210.In addition, distal end collet 1310 and/ Or the clamping face of proximal end collet 1320 is equipped with the clamping reinforcement for enhancing chucking power.Clamp reinforcement be preferably protrusion, At least one of fin, groove or pit, and the shape of the clamping reinforcement of the clamping face setting of distal end collet 1310 is answered When the shape of the clamping reinforcement with the setting of the clamping face of proximal end collet 1320 is worked in coordination, so that the distal end collet after closure It is very close to each other between 1310 and proximal end collet 1320.In the present embodiment, the clamping face and proximal end collet 1320 of distal end collet 1310 Clamping face on a plurality of parallel fin is respectively set as clamping reinforcement, when distal end collet 1310 and proximal end collet 1320 close It is very close to each other therebetween after conjunction.

Clamping push rod 1330 is tubular body or hollow rod shape body with certain axial length, together referring to Figure 10 a and figure 10b, cross section is preferably ellipse, semicircle, crescent or circle, and clamps edge in push rod 1330 and be axially arranged with suture Channel.Two suture accommodating chambers 1315 being connected with suture channel are equipped in distal end collet 1310, two sutures are received Cavity 1315 is penetrated through respectively to the clamping face of distal end collet 1310.Suture 3000 is contained in suture channel and suture receiving In chamber 1315.

The clamping face of distal end collet 1310 offers the two of two fixing pieces 3010 for being respectively used to accommodating suture 3000 A lock chamber 1313.Each lock chamber 1313 is axially connected to a suture accommodating chamber 1315 respectively.Two lock chambers 1313 Position and the positions of two piercing needles 1410 respectively correspond.Two fixing pieces 3010 of suture 3000 hold respectively as a result, It sets in distal end collet 1310, and the proximal end of each fixing piece 3010 corresponds respectively to a piercing needle 1410.

Suture 3000 is placed and secured in inside instrument by the present embodiment, avoids suture 3000 as instrument enters When patient's body, the damage of suture frictional tissue, and avoid blood from suture periphery leakage.In addition, lock chamber 1313 with The spacing that the distance between push rod 1330 is the suture 3000 and leaflet edge after being implanted into is clamped, can effectively avoid leaflet side Edge folds and generates notch, to enhance surgical effect.

Referring to Figure 10 a-10b, due to being additionally provided with Non-slip material 3020, the clamping of distal end collet 1310 on suture 3000 Face offers the container 1314 for accommodating Non-slip material 3020.Divide between container 1314 and two suture accommodating chambers 1315 Other radial communication.As a result, after two piercing needles 1410 puncture leaflet respectively and connect with a fixing piece 3010, recession two Root puncture push rod 1420 drives two piercing needles 1410 and fixing piece 3010 coupled respectively, suture 3000 and prevents Saddle 3020 is successively drawn out by the clamping face of distal end collet 1310, until piercing needle 1410, fixing piece 3010 and suture 3000 sequentially pass through leaflet, and Non-slip material 3020 conforms to the upper surface of leaflet.

The setting of lock chamber 1313 and container 1314 can need not unclamp distal end collet 1310 and proximal end collet 1320 Under the premise of suture 3000 and Non-slip material 3020 be pulled to leaflet, therefore in distal end collet 1310 and proximal end collet 1320 by closing When conjunction state is converted to open configuration, leaflet is detached from from clamp assemblies 1300, the moment of preparatory stroke, and suture 3000 will not It is individually contacted with leaflet, the linear incision effect of suture 3000 is avoided to generate injury to the leaflet of beating.

The effect of lock chamber 1313 is that both the fixing piece 3010 of suture 3000 can be fixed in lock chamber 1313, solid Determine successfully pull out out of lock chamber 1313 again after part 3010 is pulled by external force.Therefore, the shape of lock chamber 1313 with The shape of fixing piece 3010 matches, and the inscribe diameter of a circle of lock chamber 1313 is greater than the circumscribed circle of suture accommodating chamber 1315 Diameter.Preferably, the diameter ratio of the external diameter of a circle and the inscribed circle of lock chamber 1313 of suture accommodating chamber 1315 is (0.2~0.4): 1.When the cross section of lock chamber 1313 and suture accommodating chamber 1315 is circle, lock chamber 1313 it is interior The diameter that diameter of a circle is the circular cross section of lock chamber 1313 is cut, the external diameter of a circle of suture accommodating chamber 1315 is The diameter of the circular cross section of suture accommodating chamber 1315.In the present embodiment, the cross section of lock chamber 1313 is circle, diameter For D1, the cross section of suture accommodating chamber 1315 is round, a diameter of D2, and D2 is the 30% of D1.The purpose of such setting It is: if D2 is excessive, when piercing needle 1410 cooperates under the promotion for puncturing push rod 1420 with the fixing piece 3010 of suture 3000, Due to puncturing the thrust to distal end of push rod 1420, fixing piece 3010 may be slipped out of lock chamber 1313 to suture accommodating chamber In 1315, cause disposably be successfully connected between piercing needle 1410 and the fixing piece 3010 of suture 3000, extends hand The art time；If D2 is too small, the suture 3000 of suture 3000 cannot be passed through from suture accommodating chamber 1315, cause to wear After pricker head 1410 is connect with the fixing piece 3010 of suture 3000, suture 3000 cannot smoothly be pulled out to clamping push rod 1330 Clamping face.It is understood that in other embodiments, the cross section of lock chamber 1313 and suture accommodating chamber 1315 may be used also The other shapes such as ellipse, triangle, quadrangle, polygon are thought, as long as the shape of lock chamber 1313 and fixing piece 3010 Shape cooperate, and the shape of suture accommodating chamber 1315 do not influence suture 3000 wherein it is smooth by.

In order to which suture 3000 and Non-slip material 3020 successfully to be pulled out to the clamping face of distal end collet 1310, lock chamber Radial communication between 1313 and container 1314.Preferably, the width of the connected component between lock chamber 1313 and container 1314 Degree D3 is the 20%-50% of D1, and the purpose of such setting is: if D3 is excessive, the fixing piece 3010 of suture 3000 cannot jail Admittedly be fixed in the lock chamber 1313 of distal end collet 1310, be easy slipped out of lock chamber 1313, directly result in device failure； It, cannot be swimmingly by fixing piece after piercing needle 1410 is connect with the fixing piece 3010 of suture 3000 if D3 is too small 3010 pull out out of lock chamber 1313, lead to operative failure.

Clamping accessory part is additionally provided in suture implanted device 1000 referring again to Fig. 7 in order to further strengthen clamping 1500.As shown in Figure 11 a and Figure 11 b, clamping accessory part 1500 includes that at least one is actively threaded onto push conduit 1210 In clamping sub-arm 1520 and set on clamping 1520 distal end of sub-arm clamping auxiliary member 1510.In order to facilitate push, pressing from both sides Hold also settable 4th handle 1501 in 1520 proximal end of sub-arm.

As shown in figure 12, edge is axially arranged with sub-arm accommodating chamber 1250 in push conduit 1210.Before puncture, clamp auxiliary Assistant piece 1510 and clamping sub-arm 1520 are all housed in sub-arm accommodating chamber 1250.On the clamping face of proximal end collet 1320, push away The side wall of the side wall or proximal end collet 1320 that send conduit 1210 is provided with opening 1260, opening 1260 and sub-arm accommodating chamber 1250 connect, when operator to distal end push the 4th handle 1501, can drive clamping sub-arm 1520 push clamping auxiliary member 1510 are pierced by (as depicted in fig. 13 a) from opening 1260, to be supported on the lower surface of leaflet 600, stablize the leaflet of beating 600, reduce the movable amplitude of leaflet 600, cooperates with clamp assemblies 1300 to clamp and fix leaflet 600 (as illustrated in fig. 13b).

Angle α range between the axial direction of the distal portion of sub-arm accommodating chamber 1250 and the axial direction for pushing conduit 1210 is 120°-150°.The reason of being arranged in this way is, before puncture, clamping push rod 1330 and leaflet EDGE CONTACT, and distal end collet 1310 and close End collet 1320 is only capable of clamping part leaflet, need to be at every at this time in order to allow the leaflet of beating to keep stablizing convenient for puncturing as far as possible The other side opposite with edge of leaflet provides support force, it is therefore desirable to clamping auxiliary member 1510 after making to be pierced by opening 1260 with Pushing has certain angle between conduit 1210, can be supported on the following table of the other side opposite with leaflet edge of every leaflet Face clamps auxiliary member 1510 and pushes the axis that the angle between conduit 1210 is substantially equal to the distal portion of sub-arm accommodating chamber 1250 Angle α between the axial direction of push conduit 1210.

Clamping auxiliary member 1510 is the rod-like structure being made of at least one support rod.Auxiliary member 1510 is clamped by biofacies The elasticity and/or flexible material of capacitive are made, and to adapt to the anatomical structure of leaflet and the movable amplitude of leaflet, and avoid damage to valve Leaf.Elastic material is preferably shape-memory material.Clamping auxiliary member 1510 can be by metal material, polymer material or gold Category-polymer composites are made.Support rod can be the solid or hollow structure of single layer or multi-layer compound structure, can be with It is formed by individual thread or multi-filament coiling.The section of support rod can be regular circle or ellipse, crescent, semicircle The shapes such as shape, polygon.1510 smooth-shaped of auxiliary member is clamped, smooth round end is distally formed by laser spot welding, without hair The defects of thorn, seamed edge or corner angle.In the present embodiment, clamping auxiliary member 1510 is a support rod made of Nitinol, horizontal Section is circle.

Clamping sub-arm 1520 is the rod-shaped or tubulose with certain axial length, and has certain degree of hardness or rigidity to mention For supportive and can pushability.Clamping sub-arm 1520 can be the hollow or solid construction by single layer or multi-layer compound structure Metallic rod or high molecular material bar, can also be formed by individual thread or multi-filament coiling.Clamp the section of sub-arm 1520 It can be regular circle or ellipse, crescent, the partially circular, polygonal or shapes such as annular.Clamp sub-arm 1520 It can be made of metal material, polymer material or Metal polymer composite.

The supportive for clamping sub-arm 1520 and the flexibility for clamping auxiliary member 1510 can be by using different materials Clamping auxiliary member 1510 and clamping sub-arm 1520 is respectively prepared to reach.That is, clamping sub-arm 1520 is made of hard material； Clamping auxiliary member 1510 is made of elasticity and/or flexible material.It is understood that identical material system can also be used first Make clamping sub-arm 1520 and clamping auxiliary member 1510, then clamping sub-arm 1520 outside or inside add hardness compared with High material serves as a contrast silk as reinforced pipe or stiffened to guarantee the supportive (as shown in figures 14a) of clamping sub-arm 1520.

Clamping auxiliary member 1510 is at least partly made by not transmiting X-ray material.In the prior art, it is clamped in clamp assemblies Firmly before leaflet, the lower mode of rank cannot be required to judge the relative position between instrument and leaflet by operations such as X-rays, Accurately ultrasonic guidance, which must be relied on, could be moved to clamp assemblies suitable position, and pass through the beating of ultrasound observation leaflet State drives rapidly the relative motion between distal end collet and proximal end collet to clamp when leaflet is beaten to close to clamp assemblies Leaflet.Ultrasound has higher requirement to the operating technology of doctor and the analysis ability of cardiac ultrasound images, leads to cost of performing the operation Increase, operating difficulty increases, and operating time increases.In the present embodiment, auxiliary member 1510 is clamped by not transmiting X-ray material system At after clamping auxiliary member 1510 is contacted with leaflet, flexible and/or elasticity the auxiliary member 1510 that clamps is with the movable width of leaflet Degree generates corresponding swing, therefore before clamp assemblies 1300 clamp leaflet, operator can be by X-ray rapidly and accurately Judge the position of leaflet, so that more rapidly accurately operation clamp assemblies 1300 reduce operation cost and difficulty to clamp leaflet, Shorten operating time, improves success rate of operation.

It is understood that in other embodiments, in order to enhance the intensity of clamping accessory part 1500, clamping auxiliary member 1510 can also be the distressed structure being made of more support rods.It is common with clamping sub-arm 1520 after distressed structure contraction distortion It is contained in push conduit 1210.As shown in fig. 14b, distressed structure is the open bifurcation structure being made of more support rods Or umbrella-shaped structure, the included angle between bifurcation structure are less than or equal to 150 °.For the ease of the quilt in push conduit 1210 Push, clamping auxiliary member 1510 have extended state when compressive state and nature.Auxiliary member 1510 is clamped in compression shape When state, it can be housed in the sub-arm accommodating chamber 1250 of push conduit 1210 and be pushed；When clamping auxiliary member 1510 is by being open After stretching out in 1260, it is changed into extended state, may be supported on the lower surface of leaflet, stablizes the leaflet of beating.It is this to be relatively large in diameter Clamping auxiliary member 1510 and the contact surface of leaflet be the plane clamped where auxiliary member 1510, therefore, clamp auxiliary member Contact area between 1510 and leaflet is bigger, can be preferably bonded leaflet, improves clamping accessory part 1500 to leaflet Supportive.

It will also be appreciated that in other embodiments, the clamping auxiliary member 1510 of bifurcation structure or umbrella-shaped structure End can be to clamping 1520 proximal direction turnup of sub-arm, and multiple clamping auxiliary members 1510 form a depressed area, such as Figure 14 c It is shown.At this point, due to the inside turnup in each 1510 end of clamping auxiliary member and it is directed toward clamping 1520 proximal direction of sub-arm, it can The support rod end of clamping auxiliary member 1510 is avoided to stab leaflet or ventricle wall.

Referring to Figure 14 d- Figure 14 f, it will also be appreciated that in other embodiments, distressed structure can also be by more Support rod constitute closed loop configuration, closed loop configuration can be circle, diamond shape, ellipse, pyriform, polygon or other irregularly But the shape of enclosed construction can be formed.Referring to Figure 14 g, it will also be appreciated that in other embodiments, the branch of closed loop configuration At least one can also be arranged between strut has flexible and/or elasticity connecting rod 1511, with improve closed loop configuration itself Stability further enhances clamping auxiliary member 1510 to the support force of leaflet.It will also be appreciated that in other embodiments, When more support rods and connecting rod are arranged in closed loop configuration, closed loop configuration can also form laminated structure or reticular structure. It will also be appreciated that in other embodiments, thermal finalization processing can also be carried out to reticular structure, make reticular structure formation can The disk-like structure of stretcher strain, disk-like structure further thermal finalization processing can form the structures such as column, nido, oblate shape.Only It clamps auxiliary member 1510 to be made of shape-memory material, can be housed in the sub-arm accommodating chamber 1250 of push conduit 1210 And conveyed, then stretched out by opening 1260, restore to natural unfolded state, provides branch with leaflet following table face contact and to leaflet Support.It will also be appreciated that in other embodiments, clamping auxiliary member can also be that the sacculus with flat horizontal surface, sacculus are pressurized Expansion can be filled, leaflet lower surface is then supported on.

Referring again to Fig. 7, probe assembly 1600 is for detecting whether leaflet is clamped in distal end collet 1310 and proximal end folder Between first 1320.Probe assembly 1600 includes at least one probe 1610.As shown in figure 15, in the present embodiment, probe assembly 1600 include two probes 1610 being set side by side, and the distance between two probes 1610 and clamping push rod 1330 substantially phase Deng.

As shown in Figure 10 a, 16-17, in order to guarantee that probe 1610 can be stretched out from the distal end of push conduit 1210 to detect Leaflet, the axial length of probe 1610 are preferably greater than to push conduit 1210 along axial minimum length.Probe 1610 is actively It is installed in the probe channel 1270 of push conduit 1210.For ease of operation, the proximal end of probe 1610 and detection handle 1601 Connection.The clamping face of proximal end collet 1320 is equipped with probe outlet 1321, wherein stretches out certainly convenient for the distal end of probe 1610.It is corresponding The clamping face of distal end collet 1310 is equipped with probe accommodating chamber opposite with probe outlet 1321, for accommodating 1610 distal end of probe 1312.When proximal end collet 1320 and distal end collet 1310 are closed, the distal end of probe 1610 is received from after the stretching of probe outlet 1321 It is dissolved in probe accommodating chamber 1312.

As shown in figure 17, edge in conduit 1210 is pushed to be axially arranged with probe channel 1270, clamping push rod channel 1280 and wear Pierce push rod channel 1290.Clamping push rod 1330 is threaded onto the clamping push rod channel 1280 of push conduit 1210, punctures push rod 1420 are threaded onto the puncture push rod channel 1290 for pushing conduit 1210, and clamping push rod 1330 is axial equal with puncture push rod 1420 It is axial parallel with push conduit 1210.Clamping push rod channel 1280 is set to the side of push conduit 1210, and two punctures push away Bar channel 1290 is set to the other side of push conduit 1210.The setting of probe channel 1270 is in clamping push rod channel 1280 and punctures Between push rod channel 1290, and probe channel 1270 and clamping the distance between push rod channel 1280 be less than probe channel 1270 with Puncture the distance between push rod channel 1290.It is understood that when being additionally provided with sub-arm accommodating chamber in push conduit 1210 When 1250, the setting of sub-arm accommodating chamber 1250 is in clamping push rod channel 1280 and punctures between push rod channel 1290, probe channel 1270 settings are between clamping push rod channel 1280 and sub-arm accommodating chamber 1250, and probe channel 1270 and clamping push rod channel The distance between 1280 are less than the distance between probe channel 1270 and puncture push rod channel 1290.

As shown in figure 18 a, when proximal end collet 1320 and distal end collet 1310 are closed, if leaflet 600 is clamped in closely It holds between collet 1320 and distal end collet 1310, and 600 edge of leaflet is contacted with push rod 1330 is clamped, 1610 distal end of probe is from close The clamping face of end collet 1320, which is pierced by, just will receive the blocking of leaflet 600 afterwards and can not continue to be distally advanced, and show that leaflet 600 is pressed from both sides Holding effect fruit is preferable, can be punctured.In addition, when 1610 distal end of probe not can enter shown in Figure 10 a by the blocking of leaflet 600 When probe accommodating chamber 1312, also indicate that the position between 600 edge of leaflet and suture 3000 is relatively fixed.Such as Figure 18 b or figure Shown in 18c, if 600 clamp position of leaflet is poor, that is, leaflet 600 is not completely covered on the clamping face of proximal end collet 1320 Probe opening 1321, the distal end of probe 1610 can be open from probe 1321 stretch out after enter the probe of distal end collet 1310 and receive Cavity 1312, then operator needs to clamp leaflet 600 again.Therefore, the present embodiment can be effective by the probe of mechanical structure Ground detects 600 clamping effect of leaflet, and apparatus structure is simple and convenient to operate.

Referring to Figure 15, probe 1610 includes having the probe body 1661 of certain length and being set to probe body 1661 distally Probe 1662, be integrally formed therebetween or be fixedly connected.Probe body 1661 can be solid or hollow structure.It visits The section of needle main body 1661 can be regular circle or the shapes such as ellipse, crescent, partially circular, polygonal, preferably It is round.Probe 1662 be smooth outer surface solid construction or hollow structure, for the ease of push, pop one's head in 1662 shape choosing From at least one of taper, platform shape, cylindricality, spherical shape or hemispherical.Probe body 1661 and probe 1662 can be by gold Belong to material, polymer material or metal-polymer material to be made.For example, probe body 1661 can be single layer or multilayer The solid rod-like or hollow tubular structures of composite construction can also be formed by individual thread or multi-filament coiling.

The hardness of the distal portion of probe body 1661 is less than or equal to the hardness of the close end of probe body 1661.That is, The distal portion of probe body 1661 preferably there is flexible or elasticity to avoid result in leaflet puncture or damage, probe body 1661 it is close End preferably has the structure of certain degree of hardness or rigidity to provide a supporting and pushability.

The distal portion and close end of probe body 1661 can be integrated molding be also possible to individually process after by welding, The technological means generally in the art such as bonding, socket, screw thread or interference fit link together, i.e. the proximal end of probe body 1661 The close end of probe body 1661 can be respectively prepared in supportive and distal flexible by using different materials and distal portion is come in fact It is existing.It is understood that in other embodiments, the whole body of rod or tube body first can also be made using relatively soft material, Then the higher outer tube of hardness is arranged as reinforced pipe in the close end outer surface of the body of rod or tube body to improve probe body 1661 proximal support；The proximal end of the relatively soft body of rod or tube body can also be wrapped in as reinforced pipe using heat-shrink tube Portion, then heating is wrapped in the outer surface of close end after shrinking heat-shrink tube to improve the proximal support of probe body 1661. It will also be appreciated that for the body of rod or tube body made of individual thread or multi-filament coiling, it can also be by Pebax, nylon etc. Thermoplastic elastomer (TPE) is wrapped in the close end outer surface of the body of rod or tube body, and then heating is wrapped up after melting thermoplastic elastomer (TPE) It is infiltrated into the gap between more or individual thread simultaneously in outer surface, to improve the proximal support of probe body 1661.

It will also be appreciated that in other embodiments, probe assembly 1600 can only include a probe 1610, may be used also To include more probes 1610.More probes 1610 can be threaded onto jointly in an inner cavity for pushing conduit 1210, that is, pushed Conduit 1210 only has a probe channel 1270, can also be installed on respectively in the different inner cavities of push conduit 1210, that is, pushes Conduit 1210 has multiple probe channels 1270, as shown in figure 17.

It will also be appreciated that in other embodiments, the distal end of probe 1610 can connect together.Such as Figure 19 a institute Show, the distal portion of probe 1610 has certain elasticity/toughness, and is linked together by connecting rod 1620.It is detected when withdrawing When handle 1601, connecting rod 1620 is placed on the clamping face of proximal end collet 1320.As shown in Figure 19 b and Figure 19 c, proximal end collet 1320 clamping face is preferably provided for accommodating the groove 1323 of connecting rod 1620, and groove 1323 should be with 1270 phase of probe channel Connection.Correspondingly, the clamping face of distal end collet 1310 is also provided with connecting rod container 1322 for accommodating connecting rod 1620, and even Extension bar container 1322 is connected with two probe accommodating chambers 1312 respectively.When the detection hand for pushing probe assembly 1600 to distal end Handle 1601, the distal end of two probes 1610 and connecting rod 1620 stretch out proximal end collet 1320, and enter distal end collet 1310 In connecting rod container 1322 and probe accommodating chamber 1312；When proximally withdrawing detection handle 1601, two probes 1610 it is remote End and connecting rod 1620 are withdrawn from from distal end collet 1310, and probe 1610 distally accommodates the probe channel into push conduit 1210 In 1270, in the receiving to the clamping face of proximal end collet 1320 of connecting rod 1620 or in the groove 1323 of clamping face.

In the embodiment of this probe assembly, due to increasing the contact surface of probe assembly 1600 distal end and leaflet Product, is particularly suitable for detecting irregular leaflet shape.Such as shown in Figure 20, since the edge shape of leaflet 600 is irregular, i.e., Make leaflet 600 be clamped component 1300 effectively to clamp, leaflet 600 may also not cover the probe of proximal end collet 1320 just Outlet 1321, and the distal end of two probes 1610 of the present embodiment is linked together by connecting rod 1620, increases detection group Contact area between 1600 distal end of part and leaflet, can detecte leaflet and has been clamped, and then indicate that operator carries out leaflet It punctures, implant sewing line 3000.

As shown in fig. 21-22, the third of cardiac repair system is largely suture lock knot device 2000, including for solid The lock driving means being detachably connected between the suture lock 2100 and suture lock 2100 of fixed more sutures 2200, and the push control device 2300 for controlling the fixed suture 3000 of suture lock 2100 and discharging.

Wherein, as shown in Figure 24 a-27, suture lock 2100 includes lock main body 2110 and locking pin 2120, lock master Body 2110 be equipped with axially through the inner cavity 2160 for installing suture 3000, inner cavity 2160 includes being located at lock main body 2110 distal end Partial latch well 2161 and the movable chamber 2162 extended from latch well 2161 to lock 2110 proximal part of main body, latch well It is seamlessly transitted between 2161 and movable chamber 2162.The internal diameter of latch well 2161 is less than the internal diameter of movable chamber 2162.Locking pin 2120 Including sticking department 2121 and in the sliding part 2122 of 2121 two sides of sticking department setting, sticking department 2121 is limited in lock main body 2110 Inner cavity 2160 in and move upwards in the lock main body axis, i.e., the lock main body along lock main body 2110 is axially moved, 2121 two sides of sticking department form two slits between 2160 surface of inner cavity respectively, and the width of two slits is in the axial direction from living Dynamic chamber 2162 reduces to latch well 2161 is synchronous；More sutures 3000 are installed on respectively in two slits.Sticking department 2121 When movable chamber 2162, the more smooth pullings of suture 3000, when sticking department 2121 slides into latch well 2161, suture 3000 Locked portion 2121 is clamped with 2161 surface of latch well.

Preferably, the inner cavity 2160 for latching main body 2110 is symmetrical in the axial direction, and the shape of two slits and size are homogeneous Together.It is understood that in other embodiments, inner cavity 2160 in the axial direction can be asymmetric, the shape and ruler of two slits It is very little can be different, as long as slit between inner cavity 2160 and sticking department 2121 respectively with sticking department 2121 adjacent thereto and sliding The shape and size in portion 2122 match, and this asymmetric suture lock of internal structure is especially suitable for locking More sutures respectively from multiple and different diseased regions at, and the suture quantity that uses of each diseased region or material are not Identical situation.In the present embodiment, inner cavity 2160 is axially symmetric, and two shape of slit and size are identical.

4a and Figure 24 b referring to fig. 2, lock main body 2110 be column structure, shape can be cylindric, prism-shaped or Side wall is cylindric with plane.In the present embodiment, lock main body 2110 is cylindrical-shaped structure, and cylindrical-shaped structure is opposite Two side walls are plane.Main body 2110 is latched to be equipped with axially through and axially symmetric inner cavity 2160, it can in inner cavity 2160 Install one or more suture 3000.Since in certain use processes, lock main body 2110 may remain in patient's body Interior, therefore, in order to avoid injured patient, the distal end end face and proximal face for latching main body 2110 are smooth treatment.In addition, seam Zygonema lock 2100 should be made of the biocompatible materials with certain degree of hardness, and metal material or macromolecule material can be selected Expect, preferably titanium alloy, Nitinol or medical stainless steel, titanium alloy is used in the present embodiment.

Locking pin 2120 includes sticking department 2121 and the sliding part 2122 in the setting of 2121 two sides of sticking department.Sticking department 2121 Shape is not construed as limiting, and only needing can for clamping suture with contact of the forming face with face, face with line between intracavity sidewall surface To be the arbitrary shape slided in lock 2110 inner cavity 2160 of main body, sticking department 2121 is generally cylindric or with platform Cylindric, preferably cylindric with platform, cylindrical-shaped structure side is arc, and arc and 2160 wall surface formation width of inner cavity Uniform slit, wherein it is preferred that the diameter or width of sticking department 2121 be greater than sliding part 2122 diameter or width, and diameter compared with Boss is formed between big sticking department 2121 and the lesser sliding part 2122 of diameter.

As shown in Figure 24 a- Figure 25 c, lock 2110 side wall surface of main body is relatively set with through-lumen respectively in its axial direction 2160 the first guide groove 2141 and the second guide groove 2142.That is, the first guide groove 2141 and the second guide groove 2142 are separately positioned on lock On the opposite two side walls face of main body 2110.Two sliding parts 2122 of locking pin 2120 are respectively from the first guide groove 2141 and It is pierced by two guide grooves 2142 and in the first guide groove 2141 and the second guide groove 2142 along 142 axis of the first guide groove 141 and the second guide groove Axis upward sliding to sliding, i.e., in lock main body 2110.The width and locking pin of first guide groove 2141 and the second guide groove 2142 2120 2122 diametric fit of sliding part, so that two sliding parts 2122 of 2121 two sides of sticking department can be in 2141 He of the first guide groove It is free to slide in second guide groove 2142.2121 diameter of sticking department is greater than the width of the first guide groove 2141 and the second guide groove 2142, prevents Only locking pin 2120 is deviate from from the first guide groove 2141 or the second guide groove 2142.

As shown in Figure 25 a- Figure 25 c, the sticking department 2121 of locking pin 2120 edge in the inner cavity 2160 of lock main body 2110 It is axially moved.Latch main body 2110 inner cavity 2160 include at least be located at lock 2110 distal portions of main body latch well 2161 and The movable chamber 2162 extended from latch well 2161 to lock 2110 proximal end of main body.The internal diameter of latch well 2161 is less than movable chamber 2162 Internal diameter.Since latch well 2161 is located at the distal end of lock main body 2110, the effect of latch well 2161 is and locking pin 2120 cooperation of sticking department 2121 by suture 3000 to clamp and be locked in lock main body 2110.Such as Figure 25 a- Figure 26 c institute Show, in the present embodiment, latch well 2161 is the cavity of rectangular-shape, and locking pin 2120 is the circle that cylindric or side has plane Column is arranged perpendicular to the axial direction of rectangular-shape cavity, and can move axially along rectangular-shape cavity, the lock of locking pin 2120 The contact determined between portion 2121 and 2161 inner wall of latch well for latching main body 2110 is contact of the face with face, can clamp more completely Suture 3000.

As shown in Figure 26 a- Figure 26 c, more sutures 3000 pass through the inner cavity 2160 of lock main body 2110, and are located at In slit between the inner wall of the latch well 2161 of 2121 two sides of sticking department and lock main body 2110 of locking pin 2120, such as scheme Shown in 26a, after locking pin 2120 is by external force, along the first guide groove 2141 and the second guide groove 2142 to the remote of lock main body 2110 End sliding, since the inner cavity 2160 of lock main body 2110 is in axially symmetric, symmetrical two slits of formation, as illustrated in figure 26b, lock Rationed marketing 2120 can squeeze the suture 3000 in the slit of two sides simultaneously, and as shown in Figure 26 c, the sticking department 2121 of locking pin 2120 is arrived It when up to a certain position, can not continue to be distally advanced, suture 3000 is fixed on the outer of the sticking department 2121 of locking pin 2120 Between surface and the surface of latch well 2161 for latching main body 2110, reach lock state, to complete to suture 3000 It locks and fixed.As shown in figure 27, the every side of locking pin 2120 can install the suture 3000 more than one.Due to suture 3000 are each located on respectively in the slit between the side of locking pin 2120 and 2161 inner wall of latch well for latching main body 2110, because The lock of this present embodiment can effectively avoid due to suture 3000 caused by the frictional force failure between more sutures 3000 It is slipped between lock main body 2110, is particularly suitable for the case where fixing more suture 3000.

As shown in Figure 24 b, in an assembling process, in order to by locking pin 2120 be mounted on lock main body 2110 inner cavity In 2160, the diameter of the proximal part of the first guide groove 2141 and/or the second guide groove 2142 is greater than the diameter of rest part, forms one A installing port 2143, the diameter of installing port 2143 are greater than 2121 diameter of sticking department of locking pin 2120, are convenient for locking pin 2120 It is put into the inner cavity 2160 of lock main body 2110.Correspondingly, the proximal end of the first guide groove 2141 and/or the second guide groove 2142 also Equipped with the stop part 2150 for preventing locking pin 2120 isolated with main body 2110 is latched, stop part 2150 at least partly covers installing port 2143,2143 diameter of installing port after covering is less than 2121 diameter of sticking department of locking pin 2120, prevent locking pin 2120 from Deviate from from installing port 2143.

In order to reinforce locking, at least one of the outer surface of locking pin 2120 and the inner surface of latch well 2161, which are equipped with, rubs Wipe enhancement layer (not shown).Specifically, friction enhancement layer be arranged in locking pin 2120 2121 outer surface of sticking department or/and The inner surface of corresponding latch well 2161 is moved with sticking department 2121.Friction enhancement layer, which can be, to be arranged in 2121 appearance of sticking department Rough surface, the elastic surface through coarse processing of the inner surface of face and latch well 2161, are also possible in 2121 appearance of sticking department Multiple small protrusions, such as salient point or fin are arranged in the inner surface of face and latch well 2161.

As shown in Figure 24 a- Figure 24 b, lock 2110 proximal end of main body is equipped with interconnecting piece 2130 and is used for and lock driving means It is detachably connected between 2200.There are many structures of interconnecting piece 2130, to adapt to different connection types.Interconnecting piece 2130 is preferred Including the bayonet or/and fastener being arranged radially.The bayonet being arranged radially refer to the opening direction of bayonet be radially, it is corresponding Radial clamp also is provided in lock driving means 2200 or conveying device, and clamp is stitched together with bayonet to be formed bumps and match It closes, and realizes axial connection under the radial constraint of push rod 2220, after the radial constraint of push rod 2220 releases, clamp and bayonet It automatically disengages.In the present embodiment, using having the concaveconvex structure of approximate sigmoid curve shape to form interconnecting piece 2130, pushed away with lock It send the concaveconvex structure of reversed sigmoid curve shape complementary in device 2200 or conveying device to cooperate, forms seamless radial splicing. It is understood that in other embodiments, concaveconvex structure can be spliced to form by shapes such as complementary waveform, tooth forms.

Referring to fig. 2 shown in 2, lock driving means 2200 includes mandrel 2210, is actively set in outside mandrel 2210 Push rod 2220 and the handle 2320 being connected with 2220 proximal end of push rod.Suture lock 2100 is housed in 2220 distal end of push rod simultaneously It is detachably connected between 2210 distal end of mandrel.Push control device 2300 be arranged in handle 2320 with control push rod 2220 with Relative motion between mandrel 2210, so that suture lock 2100 is locked suture 3000 and distally divided with mandrel 2210 From.

As shown in Figure 28-Figure 29, in lock driving means 2200, mandrel 2210 is solid rod-shaped or hollow tubulose Structure, 2210 distal end of mandrel are used between lock main body 2110 be detachably fixed to connect.2210 distal end of mandrel is equipped with radial Clamp 2211, clamp 2211 and the bayonet or/and fastener of interconnecting piece 2130 are stitched together.

As shown in figure 29, handle 2320 is hollow structure, and surface texture is suitble to operator to hold.2320 proximal end of handle is equipped with Mandrel fixing piece 2212, it is non-dismountable between 2210 proximal end of mandrel and mandrel fixing piece 2212 to be fixedly connected or the company of being detachably fixed It connects, it is non-dismountable between mandrel fixing piece 2212 and 2320 proximal end of handle to be fixedly connected with or be detachably fixed connection.Mandrel is fixed The shape and structure of part 2212 are not construed as limiting, and be can be and any be capable of fixing mandrel 2210 and form a fixed connection with handle 2320 Structure, in the present embodiment, 2212 distal portions of mandrel fixing piece are that the card slot in block structure, with handle 2320 cooperates card It connects, to be fixed in handle 2320, the proximal end of mandrel fixing piece 2212 is cylindrical-shaped structure, is pierced by 2320 proximal end of handle.For Blood leakage is avoided, gasket seal made of elastic material is set in the proximal part of mandrel fixing piece 2212.

Referring again to Figure 23 a to Figure 23 c, push rod 2220 is hollow tubular structure, and mandrel 2210 is installed in push rod 2220, Lock main body 2110 is contained in 2220 distal end of push rod.2220 distal end of push rod is equipped with arc-shaped opposite notch 2221, notch 2221 position and shape are matched with the external surface shape of the sliding part 2122 of the two sides of locking pin 2120 respectively.Such as Figure 23 a Shown, two sliding parts 2122 are pierced by from the first guide groove 2141 and the second guide groove 2142 respectively and are overlapped in notch 2221. When operator pushes push rod 2220 to the distal end of lock main body 2110 as a result, notch 2221 can push 2120 two sides of locking pin Sliding part 2122, so that entire locking pin 2120 is mobile to distal end relative to lock main body 2110.

Push control device 2300 is used to control the relative motion between push rod 2220 and mandrel 2210, so that suture is locked Suture 3000 is locked and is fixed in lock main body 2110 and drives suture lock 2100 from push rod 2220 by button 2100 It frees distal end.As shown in Figure 21-Figure 22 and Figure 28-Figure 29, push control device 2300 includes the push rod in handle 2320 Fixing piece 2222, the limit interconnecting piece 2320 being distally connected with push rod fixing piece 2222 and the driving being fixed on push rod 2220 Retaining mechanism 2310.The proximal end of push rod 2220 from driving 2310 proximal end of retaining mechanism and limit 2320 proximal end of interconnecting piece stretch out after with Push rod fixing piece 2222 is fixedly connected.It is spirally connected between driving retaining mechanism 2310 and limit interconnecting piece 2320 so that driving locking Mechanism 2310 is axially moved along handle 2320, thus axial fortune of the driving push rod 2220 relative to handle 2320 and mandrel 2210 It is dynamic.

Push rod fixing piece 2222 is installed in handle 2320.It is non-disconnectable between 2220 proximal end of push rod and push rod fixing piece 2222 It unloads and is fixedly connected with or is detachably fixed connection.The shape and structure of push rod fixing piece 2222 are not construed as limiting, and it is solid to can be any energy Determine the structure of push rod 2220, uses cylindrical-shaped structure in the present embodiment.

Limiting interconnecting piece 2320 is the tubular structure being fixed on outside push rod 2220, and the distal end of limit interconnecting piece 2320 is equipped with outer Screw thread, for being threadedly coupled between the internal screw thread of driving retaining mechanism 2310.Rotation driving retaining mechanism 2310 can band as a result, Dynamic limit interconnecting piece 2320 is axially moved, so that push rod 2220 be driven to be axially moved.

Driving retaining mechanism 2310 includes multiple tooth holding section 2302 and the appropriate precession control being connected with multiple tooth holding section 2302 Mechanism 2301 processed.Multiple tooth holding section 2302 is tubular structure, and inner wall is equipped with internal screw thread and sets with the distal end for limiting interconnecting piece 2320 Some external thread bolt connections.The circumferential circle of multiple tooth 2302 outer wall of holding section is equipped with the bar shaped tooth of multiple axial alignments.

As shown in Figure 29-Figure 31, appropriate precession control mechanism 2301 includes the hand for operator's gripping and rotation process Wheel 2311, the drive connection part 2313 that connection is detachably fixed in handwheel 2311 and with multiple tooth holding section 2302, and be set to Appropriate retainer 2312 between handwheel 2311 and drive connection part 2313, appropriate retainer 2312 and drive connection part 2313 it Between be fixedly connected, the flexible clamping between handwheel 2311,2311 rotatory force of handwheel exceed snapping resistance when, handwheel 2311 relative to Appropriate retainer 2312 slides.Specifically, appropriate retainer 312 can be using being at least partly made of elastic material, can also be with The rigid material using high-tenacity, when appropriate retainer 2312 is by certain external force as a result, can deformation occurs and by It is skidded off in drive connection part 2313.When the driving force that handwheel 2311 drives drive connection part 2313 to rotate is less than appropriate retainer The stress that 2312 deformations skid off, handwheel 2311 drive drive connection part 2313 to turn to a direction by appropriate retainer 2312 It is dynamic；When the driving force that handwheel 2311 drives drive connection part 2313 to rotate skids off the appropriate deformation of retainer 2312 (that is, occurring " stripped thread " phenomenon) when, handwheel 2311 rotates alone relative to drive connection part 2313.

Appropriate retainer 2312 includes being arranged at least on 2311 inner wall of handwheel or on 2313 outer wall of drive connection part One elastic chuck 2314, on corresponding 2313 outer wall of drive connection part or 2311 inner wall of handwheel is equipped with multiple card slots 2315 To cooperate with elastic chuck 2314.The side wall of each card slot 2315 is equipped with sliding surface 2316.Elastic chuck 2314 is caught in card slot After 2315, the end of elastic chuck 2314 and sliding surface 2316 are overlapped, and the rotation of handwheel 2311 drives drive connection part 2313 to rotate. Sliding surface 2316 is the inclined-plane for smoothly taking turns the setting of 311 direction of rotation, when drive connection part 2313 is by rotational resistance stop, hand 2311 rotation of wheel forces elastic chuck 2314 that flexible deformation occurs and skids off card slot 2315 along sliding surface 2316, and handwheel 2311 is opposite Drive connection part 2313 rotates alone.Card slot 2315 further includes the motion-stopping surface 2317 opposite with sliding surface 2316, motion-stopping surface 2317 It is the inclined-plane oppositely arranged with 2311 direction of rotation of handwheel.The end of elastic chuck 2314 and motion-stopping surface 2317 overlap, motion-stopping surface 2317 prevention elastic chucks 2314 skid off card slot, drive drive connection part 2313 to rotate backward so that handwheel 2311 reversely rotates.

Elastic chuck 2314 is spiral spring plate or the curved elastic pawl of stress；Or elastic chuck 2314 includes elasticity Part and the top-pressure part being arranged in the end of elastic component.

Appropriate precession control mechanism 2301 can prompt the locking degree of suture 3000 as a result, avoid suture 3000 The damage of main body 2110 is not locked and latched.When screwing suitable position, suture 3000 is locked pin 2120 and lock main body 2110 inner cavity 2160, which squeezes, can not extremely continue to deform, and rotation meets obstructions, and resistance is transferred to appropriate precession control mechanism 2301, When continuing turn handwheel 2311, appropriate precession control mechanism 2301 cannot be continued to rotate due to meeting obstructions, in driving force and resistance Under acting on while power, deformation occurs for 2314 stress of elastic chuck in appropriate precession control mechanism 2301, when deformation is accumulated to To a certain degree, then stripped thread phenomenon occurs, multiple tooth holding section 2302 and the screw thread of limit interconnecting piece 2320 cannot be further continued for screwing, from And avoid rotation that lock main body 2110 is excessively caused to be extruded damage.Meanwhile stripped thread phenomenon can also prompt operator, it is locked It can not continue the state of deformation to suture 3000, operator can carry out the surgical procedure of next step；If stripped thread phenomenon does not occur, Illustrate that suture 3000 is not yet completely fixed, it is still necessary to continue rotation hand wheel 2311 until stripped thread.

As shown in Figure 21-Figure 22 and Figure 28-Figure 29, handle 2320 is equipped with the first locking press button 2330 and the second locking Button 2340, the first locking press button 2330 and the second locking press button 2340 can be moved radially, specifically in handle 2230 On offer at least two limited mouths, the first locking press button 2330 and the second locking press button 2340 are installed on one of limit respectively In the mouth of position, one end is limited in handle 2230, and the other end is located at outside handle 2230, operator can to the first locking press button 2330 and The operation of second locking press button 2340 progress radial motion.Make it to 2210 side of mandrel when radially pressing the first locking press button 2330 To when movement, the proximal end face of multiple tooth holding section 2302 is axially supported in the end of the first locking press button 2330, limits multiple tooth holding section 2302 along axial proximal movement, so that the appropriate precession control mechanism 2301 that limitation is connected with multiple tooth holding section 2302 is proximally Direction movement；When radially pressing the second locking press button 340 keeps it mobile to 210 direction of mandrel, the second locking press button 2340 End is radially supported between two teeth of multiple tooth holding section 2302, and the rotation of multiple tooth holding section 2302 is limited, thus limitation with The rotation of the connected appropriate precession control mechanism 2301 in multiple tooth holding section 2302.

As shown in Figure 32-33, there are also another different embodiments to be for suture lock knot device 2000: push rod 2220 with Relative position between handle 2320 remains unchanged, and push control device 2300 is connected with mandrel 2210, then passes through push Control device 2300 drives the axial movement of mandrel 2210, so that mandrel 2210 generates relative motion relative to push rod 2220, from And the locking pin 2120 for reaching promotion lock main body 2110 is locked and fixed suture 3000, and lock main body 2110 is pushed away certainly The purpose discharged in 2220 distal end of bar.Specific structure are as follows: push control device 2300 includes mandrel fixing piece 2212, limit connection Portion 2320 and the driving retaining mechanism 2310 being fixed on mandrel 2210.The proximal end of mandrel 2210 drives retaining mechanism 2310 certainly Proximal end and limit 2320 proximal end of interconnecting piece are connect after being pierced by with mandrel fixing piece 2212, and driving retaining mechanism 2310 and limit connect Be spirally connected between portion 2320 so that drive retaining mechanism 2310 along handle 2320 be axially moved, thus drive mandrel 2210 relative to The axial movement of handle 2320 and push rod 2220.Limiting interconnecting piece 2320 is the tubular structure being fixed on outside mandrel 2210, limit It is threadedly coupled between the distal end of interconnecting piece 2320 and driving retaining mechanism 2310.

Illustrate implementation process of the Heart valve repair system provided in this embodiment for mitral valve reparation below:

Step 1: suture implanted device 1000 is advanced into left ventricle, continue to promote suture implanted device 1000 Until distal end collet 1310 and proximal end collet 1320 are respectively positioned in atrium sinistrum；

Step 2: referring to Figure 34, proximally withdrawing push conduit 1210 or pushing clamping push rod 1330 to distal end, make It obtains proximal end collet 1320 to separate with distal end collet 1310, referring to Figure 35, pushes the 4th handle 1501 to distal end, clamp sub-arm 1520 push clamping auxiliary members 1510 are pierced by from opening 1260, are clamped auxiliary member 1510 at this time and are supported on leaflet lower surface to assist The leaflet stablized and beaten is helped, the relative position between holding first handle 1201, second handle 1301 and the 4th handle 1501 is not Become, proximally slowly move entire instrument, until leaflet enters the valve formed between proximal end collet 1320 and distal end collet 1310 In leaf accommodation space, and clamping auxiliary member 1510 can provide leaflet certain support force；

Step 4: referring to Figure 36, the distal end of slight mobile suture implanted device 1000, until leaflet edge is pushed away with clamping Bar 1330 contacts, second handle 1301 of proximally dropping back at this time, driving distal end collet 1310 proximally collet 1320 it is mobile until The two closure, leaflet are clamped；

Step 5: keeping 1201 position of first handle constant, detection handle 1601 is pushed to distal end, probe 1610 is to distally It is mobile；If leaflet clamp position is good, the distal end of probe 1610 cannot be stretched out from probe opening 1321 and enter distal end collet 1310 probe accommodating chamber 1312 can carry out subsequent operation；If leaflet clamp position is poor, the distal end of probe 1610 can be with The probe accommodating chamber 1312 for entering distal end collet 1310 after stretching out from probe opening 1321, needs to repeat at this time second step to the 4th The operation of step clamps leaflet again；When operator find leaflet do not clamped effectively, can be with fine adjustment of remote collet 1310 and proximal end Relative distance between collet 1320, then the relative position between clamping push rod 1330 and leaflet is adjusted, clamping group is operated again Part 1300 is to clamp leaflet, then carries out the surgical procedure of the 5th step；During adjustment, due to the clamping auxiliary below leaflet Component 1500 has certain supporting role to leaflet, can prevent leaflet from slipping from clamp assemblies 1300；

Step 6: as shown in figure 37, pushing third handle 1401 to distal end, piercing needle 1410 is mobile to distal end, until It forms a fixed connection across leaflet, and between the fixing piece of suture 3,000 3010, as shown in figure 38；

Step 7: referring to Figure 39, third handle 1401 of dropping back, so that piercing needle 1410 drives the fixation of suture 3000 Part 3010, the suture 3000 being connected with fixing piece 3010 sequentially pass through leaflet, and Non-slip material 3020 is also by from distal end collet 1310 Clamping face be drawn out, the binding face (that is, lower surface) of Non-slip material 3020 is contacted with the upper surface of leaflet, while partial suture The upper surface that line 3000 pushes down Non-slip material 3020 makes its be bonded leaflet (as shown in figure 40), at this point, suture 3000 and leaflet it Between point contact be converted into the face contact between Non-slip material 3020 and leaflet, can effectively reduce leaflet 600 tearing risk；

Step 8: the third handle 1401 that continues to drop back is until fixing piece 3010 is withdrawn from from the proximal end of push conduit 1210, so The 4th handle 1501 of recession drives clamping auxiliary member 1510 to withdraw into sub-arm accommodating chamber 1250, withdraws from entire suture Implanted device 1000, the suture 3000 for completing bicuspid valve side leaflet are implanted into；

Step 9: the operation of the first step to the 8th step is repeated, the leaflet implant sewing line 3000 in the bicuspid valve other side, then More sutures 3000 in the leaflet of two sides are penetrated outside the patient's body the suture lock 2100 of suture lock knot device 2000 Inner cavity 2160 in, when wearing by the suture 3000 of every side lobe leaf respectively be through lock main body 2110 2160 side of inner cavity it is narrow In seam；

Step 10: mandrel 2210 and 2220 distal end of push rod are pushed into heart through the apex of the heart, to two as shown in Figure 41 a and Figure 41 b The leaflet of cusp moves close to, while pulling more sutures 3000, when leaflet is closed into the degree of needs, the first locking of release Button 2330 stirs handwheel 2311, and as shown in Figure 42 a and Figure 42 b, 2220 distal movement of push rod, notch 2221 pushes locking The sliding part 2122 of pin 2120 along the first guide groove 2141 and the second guide groove 2142 relative to lock main body 2110 to distally moving, And continuous extrusion suture 3000, until locking pin 2120 can not continue to move to, more at this time sutures 3000 are by solid securely It is scheduled in suture lock 2100；

Step 11: unclamping the second locking press button 2340 as shown in Figure 43 a and Figure 43 b, reversely stirring handwheel 2311, push away Bar 2220 is dropped back, after the interconnecting piece 2130 and 210 distal end of mandrel that latch main body 2110 all expose from push rod 2220, push rod 2220 radial constraint releases, and the interconnecting piece 2130 of script male-female engagement is separated with 2210 distal end of mandrel, suture lock 2100 It frees, it is external mandrel 2210 and push rod 2220 are withdrawn from patient to continue recession handle 2320；

Step 12: as shown in figure 44, cutting extra suture 3000, suture lock 2100 and remaining suture are stayed In patient's body, mitral frontal lobe 1010 and rear leaf 1020 are pulled towards each other by more sutures 3000 at this time, and being formed has two " the diplopore structure " of a hole G completes the edge of valve to edge reparation (as shown in figure 45).

The above is only the preferred embodiment of the utility model only, is not intended to limit the utility model, all at this Made any modifications, equivalent replacements, and improvements etc., should be included in the utility model within the spirit and principle of utility model Protection scope within.

Claims (25)

1. a kind of Heart valve repair system, which is characterized in that there is the suture of certain axial length including at least two, use In the suture implanted device that the suture is implanted into valvular different leaflet respectively and will at least two sutures The suture lock knot device that line is fixed together；

The suture implanted device includes pushing conduit, the clamp assemblies for clamping leaflet and for puncturing wearing for leaflet Component is pierced, the clamp assemblies and the piercing assembly are actively arranged in the push conduit, and the suture is placed in In the clamp assemblies；

The suture lock knot device includes for the suture lock of fixed at least two sutures and the suture The lock driving means that is detachably connected between lock and for controlling the fixed suture of the suture lock and discharging Push control device.

2. Heart valve repair system according to claim 1, which is characterized in that the clamp assemblies include described in receiving The clamping push rod of suture and the distal end collet and proximal end collet of opposite folding, the distal end collet setting are pushed away in the clamping The distal end of the push conduit is arranged in the distal end of bar, the proximal end collet.

3. Heart valve repair system according to claim 2, which is characterized in that edge is axially arranged in the clamping push rod Suture channel, the distal end collet is interior to be equipped with the suture accommodating chamber penetrated through to the clamping face of the distal end collet, the seam Zygonema channel is connected with the suture accommodating chamber, and the suture is contained in the suture channel and the suture is received In cavity.

4. Heart valve repair system according to claim 3, which is characterized in that be arranged on the suture along described Suture Non-slip material in axial sliding.

5. Heart valve repair system according to claim 4, which is characterized in that the clamping face of the distal end collet opens up There is the Non-slip material container that Non-slip material is stated for collecting post, it is radial between the Non-slip material container and the suture accommodating chamber Connection.

6. Heart valve repair system according to claim 5, which is characterized in that in the both ends of the suture at least One end is connected with fixing piece, non-dismountable between the fixing piece and the piercing assembly to be fixedly connected or the company of being detachably fixed It connects.

7. Heart valve repair system according to claim 6, which is characterized in that the clamping face of the distal end collet opens up There is the lock chamber for accommodating the fixing piece, is axially connected between the lock chamber and the suture accommodating chamber, it is described solid Determine radial communication between chamber and the Non-slip material container.

8. Heart valve repair system according to claim 7, which is characterized in that the shape of the lock chamber with it is described solid The shape for determining part matches, and the inscribe diameter of a circle of the lock chamber is greater than the straight of the circumscribed circle of the suture accommodating chamber Diameter.

9. Heart valve repair system according to any one of claims 1 to 8, which is characterized in that the suture implantation Device further includes clamping accessory part；The clamping accessory part includes that at least one is actively threaded onto the push conduit Clamping sub-arm and set on it is described clamping sub-arm distal end clamping auxiliary member；The clamping auxiliary member is by elastic and/or soft Property material is made；The clamping sub-arm pushes the clamping auxiliary member from the push distal end of catheter or proximal end collet side Face is pierced by.

10. Heart valve repair system according to claim 9, which is characterized in that the clamping auxiliary member is at least partly It is made by not transmiting X-ray material.

11. Heart valve repair system according to claim 9, which is characterized in that the clamping auxiliary member is by least A piece support rod constitute rod-like structure perhaps the clamping auxiliary member be the distressed structure being made of more support rods or The clamping auxiliary member is the sacculus with flat horizontal surface.

12. Heart valve repair system according to any one of claims 1 to 8, which is characterized in that the piercing assembly Push rod is punctured including at least one and set on the piercing needle for puncturing push rod distal end, the distal end of the piercing needle is taper Straight tip, it is detachable between the piercing needle and the fixing piece or non-dismountable be fixedly connected.

13. Heart valve repair system according to any one of claims 1 to 8, which is characterized in that the suture is planted Entering device further includes probe assembly, and the probe assembly includes at least one probe, is installed on to the probe activity described push away It sending in conduit, the proximal end collet and the distal end collet correspond to the probe and are respectively equipped with probe outlet and probe accommodating chamber, The distal end of the probe is contained in the probe accommodating chamber from probe outlet stretching.

14. Heart valve repair system according to claim 13, which is characterized in that the axial length of the probe is greater than The push conduit is along axial minimum length.

15. Heart valve repair system according to claim 13, which is characterized in that the probe includes having a fixed length The probe body of degree and probe set on the probe body distal end, the probe body are solid construction or hollow structure, The probe is the solid construction or hollow structure of smooth outer surface.

16. Heart valve repair system according to any one of claims 1 to 8, which is characterized in that the suture lock Button includes lock main body and locking pin；

It is described lock main body be equipped with axially through the inner cavity for installing suture, the inner cavity include be located at the lock main body it is remote The latch well of end part and the movable chamber extended from the latch well to the lock proximal, the internal diameter of the latch well Less than the internal diameter of the movable chamber；

The locking pin includes sticking department and the sliding part in sticking department two sides setting, and the sticking department is limited in the lock It detains in the inner cavity of main body and is moved upwards in the axis of the lock main body, the table of the two sides of the sticking department and the inner cavity Two slits are formed between face, the width of described two slits is on lock main body is axial from the movable chamber to the latch well It is synchronous to reduce；

More sutures are installed on respectively in described two slits, when the sticking department is located at the movable chamber, the more seams The smooth pulling of zygonema, when the sticking department slides into the latch well, the suture is by the sticking department and the latch well Surface clamp.

17. Heart valve repair system according to claim 16, which is characterized in that the side wall surface of the lock main body exists The first guide groove and the second guide groove penetrated through respectively to the inner cavity is relatively set in its axial direction；Described in two of the locking pin Sliding part is pierced by from first guide groove and second guide groove respectively and along first guide groove and the second guide groove axis To sliding.

18. Heart valve repair system according to claim 16, which is characterized in that the lock proximal, which is equipped with, to be used In the interconnecting piece that the distal end with the lock driving means is detachably connected.

19. Heart valve repair system according to any one of claims 1 to 8, which is characterized in that the lock push Device includes mandrel, the push rod for being actively set in the mandrel exterior and the handle being connected with the push rod proximal end, the seam Zygonema lock is housed in the push rod distal end and is detachably connected between the mandrel distal end；

The relative motion controlled between the push rod and the mandrel in the handle is arranged in the push control device.

20. Heart valve repair system according to claim 19, which is characterized in that the push control device includes setting It push rod fixing piece in the handle, the limit interconnecting piece being connected with the push rod fixing piece distal end and pushes away described in being fixed on Driving retaining mechanism on bar；It is worn from the driving retaining mechanism proximal end and the limit interconnecting piece proximal end proximal end of the push rod It connect after out with the push rod fixing piece, is spirally connected between the driving retaining mechanism and the limit interconnecting piece so that the drive Dynamic retaining mechanism is axially moved along the handle, to drive the push rod relative to the axial fortune of the handle and the mandrel It is dynamic；

Or the push control device includes mandrel fixing piece, limit interconnecting piece and fixed driving lock on the mandrel Tight mechanism；The proximal end of the mandrel is pierced by the rear and core from the driving retaining mechanism proximal end and the limit interconnecting piece proximal end The connection of axis fixing piece, is spirally connected so that the driving retaining mechanism edge between the driving retaining mechanism and the limit interconnecting piece The handle is axially moved, to drive the mandrel relative to the axial movement of the handle and the push rod.

21. Heart valve repair system according to claim 20, which is characterized in that the driving retaining mechanism includes more Tooth holding section and the appropriate precession control mechanism being connected with the multiple tooth holding section.

22. Heart valve repair system according to claim 21, which is characterized in that the appropriate precession control mechanism packet Handwheel is included, in the handwheel and the drive connection part of connection is detachably fixed between the multiple tooth holding section and is set to Appropriate retainer between the handwheel and the drive connection part；The appropriate retainer is at least partly by elastic material or tough Property material is made；It is fixedly connected between the appropriate retainer and the drive connection part, and the elastic card between the handwheel It connects, when the rotatory force of the handwheel exceeds the snapping resistance, the handwheel is slided relative to the appropriate retainer.

23. Heart valve repair system according to claim 22, which is characterized in that the appropriate retainer is included in institute State at least one elastic chuck being arranged on handwheel inner wall or on the drive connection part outer wall, the corresponding drive connection On part outer wall or the handwheel inner wall is equipped with multiple card slots to cooperate with the elastic chuck, and the rotatory force of the handwheel is super Out when the snapping resistance, the elastic chuck skids off from the slot.

24. Heart valve repair system according to claim 23, which is characterized in that the side wall of each card slot is equipped with Sliding surface；After the elastic chuck is caught in the card slot, the end of the elastic chuck and the sliding surface are overlapped, the handwheel Rotation drives the drive connection part rotation, and the rotatory force of the handwheel exceeds the clamping of the sliding surface and the elastic chuck When resistance, the elastic chuck skids off from the slot；

Each card slot is additionally provided with the motion-stopping surface being oppositely arranged with the sliding surface, and the end of the elastic chuck is stopped with described Dynamic face overlap joint is to prevent the elastic chuck from skidding off the card slot, so that the handwheel, which reversely rotates, drives the drive connection part It rotates backward.

25. Heart valve repair system according to claim 20, which is characterized in that the handle, which is equipped with, can distinguish diameter To the first locking press button and the second locking press button of movement, when first locking press button is mobile to the mandrel direction, end The proximal end face of the multiple tooth holding section is supported to limit the multiple tooth holding section along axial proximal movement, second locking in portion When button is mobile to the mandrel direction, end is supported described multiple tooth to limit between two teeth of the multiple tooth holding section The rotation of holding section.