CN109833117A

CN109833117A - Bilateral artificial cords implant system

Info

Publication number: CN109833117A
Application number: CN201711214263.2A
Authority: CN
Inventors: 张庭超; 张伟伟; 潘湘斌; 孟旭
Original assignee: Hangzhou De Jin Medical Technology Co Ltd
Current assignee: Hangzhou De Jin Medical Technology Co Ltd
Priority date: 2017-11-28
Filing date: 2017-11-28
Publication date: 2019-06-04
Anticipated expiration: 2037-11-28
Also published as: CN109833117B; WO2019105073A1

Abstract

Bilateral artificial cords implant system disclosed by the invention, including clamping device, sting device and driving means, driving means includes push conduit, clamping device includes clamping push rod and distal end collet and proximal end collet for cooperating clamping leaflet, the distal end of push conduit is arranged in proximal end collet, the distal end of clamping push rod is arranged in distal end collet, the clamping push rod is actively at the approximate centre axis of push conduit, sting device includes at least a pair of piercing needle for puncturing push rod and being respectively arranged on puncture push rod distal end, push rod is punctured actively to be installed in push conduit and be symmetrical set about clamping push rod.Bilateral artificial cords implant system of the invention can clamp mitral frontal lobe and rear leaf simultaneously, and then greatly shorten operating time in mitral frontal lobe and rear leaf implantable artificial chordae tendineae simultaneously, improve procedure efficiency.

Description

Bilateral artificial cords implant system

Technical field

The invention belongs to the field of medical instrument technology, are related to a kind of instrument more particularly to one for repairing heart valve defect Kind bilateral artificial cords implant 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.Referring to Figure 1, the bicuspid valve of normal health has more chordae tendineaes.Before mitral leaflet is divided into Leaf and rear leaf, when left ventricle is in diastole state, the two is in open configuration, and blood flows to left ventricle from atrium sinistrum；Left ventricle When in contraction state, chordae tendineae is stretched, and guarantees that leaflet will not be flushed to atrial side by blood flow, forward and backward leaf closure is good, to protect Card blood flows to aorta by aorta petal (referred to as: AV) from left ventricle.If there is lesion, such as Fig. 2 in chordae tendineae or papillary muscle Shown in after leaf rupture of chordae tendinca, when left ventricle be in contraction state, bicuspid valve cannot be as restoring when normal condition to closing shape State, the impulse force of blood flow can further result in leaflet and take off into atrium sinistrum, cause blood reflux.

The mode for generalling use surgical operation implantable artificial chordae tendineae at present treats chordae tendineae lesion, needs to open chest using invasive Technology, and general anesthesia, Moderate hypothermia cardiopulmonary bypass are carried out as auxiliary support.There are surgical procedure complexity, hand for this kind of surgical operation The defects of art is at high cost, patient trauma degree is high, complication risk is high, the hospital stays is long and patient's recovery process is painful.

Another therapeutic modality is by invasive manner implantable artificial chordae tendineae.In the prior art, invasive manner implantable artificial The instrument that chordae tendineae uses includes Handleset, the capture components such as component and syringe needle；Leaflet is captureed by closeable capture component After obtaining, syringe needle is recycled to pierce through leaflet, then hooks and take artificial cords.This instrument operate every time be only capable of in mitral frontal lobe or Side implantable artificial chordae tendineae after person in leaf, procedure efficiency is lower, takes a long time.

Summary of the invention

The technical problem to be solved in the present invention is that in view of the above-mentioned drawbacks in the prior art, providing one kind can exist simultaneously Mitral frontal lobe and rear leaf implantable artificial chordae tendineae, the bilateral artificial cords implantation system for improving procedure efficiency, saving operating time System.

The technical solution adopted by the present invention to solve the technical problems is:

Bilateral artificial cords implant system, including clamping device, sting device and driving means.The driving means includes Push conduit.The push conduit is along the inner cavity for being axially arranged with multiple perforations.The clamping device includes clamping push rod and is used for The distal end collet and proximal end collet of cooperation clamping leaflet.The distal end of the push conduit is arranged in the proximal end collet.It is described remote The distal end of the clamping push rod is arranged in end collet.The clamping push rod is actively installed on the approximate centre of the push conduit At axis.The sting device includes at least a pair of piercing needle for puncturing push rod and being respectively arranged on the puncture push rod distal end.Institute Puncture push rod is stated actively to be installed in the push conduit and be symmetrical set about the clamping push rod.It is of the invention as a result, The clamping device of bilateral artificial cords implant system can clamp mitral frontal lobe and rear leaf simultaneously, then pushed away by being located at clamping At least a pair of push rod that punctures of bar two sides drives piercing needle to puncture mitral frontal lobe and rear leaf respectively, and then realizes bilateral Artificial cords implantation.

In the bilateral artificial cords implant system, the distal end of the preferably described piercing needle is the straight tip of taper.

In the bilateral artificial cords implant system, the diameter range of the preferably described push conduit is 10mm to 12mm.

In the bilateral artificial cords implant system, the preferably described bilateral artificial cords implant system further includes at least one To artificial cords.The every artificial cords, which include one section, has chordae tendineae main body flexible.The chordae tendineae main body has opposite First end and second end.The first end and/or the second end are connected with fixing piece.The fixing piece with described for wearing Pricker head is non-dismountable to be fixedly connected with or is detachably fixed connection.

In the bilateral artificial cords implant system, the preferably described chordae tendineae main body is placed in the clamping push rod and described In the collet of distal end.The fixing piece is placed in the distal end collet, and the proximal end of each fixing piece respectively corresponds one The piercing needle.

It is logical along artificial cords are axially arranged in the preferably described clamping push rod in the bilateral artificial cords implant system Road, is equipped with artificial cords accommodating chamber in the distal end collet, and the artificial cords accommodating chamber penetrates through close to the distal end collet End face.The artificial cords channel is connected with the artificial cords accommodating chamber, and the chordae tendineae main body is contained in the artificial tendon In Suo Tongdao and the artificial cords accommodating chamber.

In the bilateral artificial cords implant system, the proximal end face of the preferably described distal end collet is equipped with described for accommodating The lock chamber of fixing piece.It is axially connected between the lock chamber and the artificial cords accommodating chamber.

In the bilateral artificial cords implant system, the shape and the shape phase of the fixing piece of the preferably described lock chamber Cooperation, and the inscribe diameter of a circle of the lock chamber is greater than the external diameter of a circle of the artificial cords accommodating chamber.

In the bilateral artificial cords implant system, Non-slip material is also arranged in the preferably described chordae tendineae main body.It is described anti- Saddle is equipped with the binding face being bonded with leaflet, and the Non-slip material slides axially along the chordae tendineae main body.

In the bilateral artificial cords implant system, artificial cords accommodating chamber, institute are equipped in the preferably described distal end collet The clamping face for stating distal end collet is equipped with container for accommodating the lock chamber of the fixing piece and for accommodating the Non-slip material, Radial communication between the container and the artificial cords accommodating chamber, radially connects between the container and the lock chamber It is logical.

In the bilateral artificial cords implant system, the preferably described bilateral artificial cords implant system further includes that clamping is auxiliary Help device.The clamping auxiliary device includes at least two clamping sub-arms being actively threaded onto the push conduit and divides It She Yu not the clamping auxiliary member that sub-arm distal end be clamped.Described at least two, which clamp sub-arm about the clamping push rod, is in It is symmetrical arranged.The clamping auxiliary member is made of elasticity and/or flexible material.The clamping sub-arm pushes coupled institute It states clamping auxiliary member to be pierced by from the push distal end of catheter or clamping device distal end, the clamping auxiliary member and the clamping Device cooperation clamping leaflet.

In the bilateral artificial cords implant system, edge is axially arranged with sub-arm receiving in the preferably described push conduit The axial angular range between the axial direction of the push conduit of chamber, the distal portion of the sub-arm accommodating chamber is 120- 150°。

In the bilateral artificial cords implant system, the preferably described clamping auxiliary member is made by not transmiting X-ray material.

Bilateral artificial cords implant system of the invention compared with prior art, at least has the advantages that clamping Push rod is arranged at the approximate centre axis of push conduit, and at least a pair of push rod that punctures is arranged in push conduit and pushes away about clamping Bar is symmetrical arranged, thus by relative motion between proximal end collet and distal end collet can clamp simultaneously mitral frontal lobe and after Leaf, and then operating time is greatly shortened in mitral frontal lobe and rear leaf implantable artificial chordae tendineae simultaneously, improve procedure efficiency.

Detailed description of the invention

Present invention will be further explained below with reference to the attached drawings and examples, in attached drawing:

Fig. 1 is the schematic diagram of normal chordae tendineae in heart；

Fig. 2 is the schematic diagram of rupture of chordae tendinca in heart；

Fig. 3 is the structural schematic diagram of the bilateral artificial cords implant system of the embodiment of the present invention one；

Fig. 4 is the structural schematic diagram in the bilateral artificial cords implant system of Fig. 3, when clamping device is closed；

Fig. 5 is the structural schematic diagram of artificial cords in the bilateral artificial cords implant system of Fig. 3；

Fig. 6 is the structural schematic diagram of the another embodiment of artificial cords；

Fig. 7 is the structural schematic diagram of the another embodiment of artificial cords；

Fig. 8 is the structural schematic diagram that fixing piece is connect with piercing needle in the bilateral artificial cords implant system of Fig. 3；

Fig. 9 is to clamp the structural schematic diagram of push rod and distal end collet in the bilateral artificial cords implant system of Fig. 3；

Figure 10 is the structural schematic diagram of the proximal end face of the distal end collet of Fig. 9；

Figure 11 is the A-A cross-sectional view of Figure 10；

Figure 12 a- Figure 12 c is the schematic diagram of the another embodiment of the proximal end face of distal end collet, wherein Figure 12 a is remote The structural schematic diagram of the proximal end face of collet is held, Figure 12 b is the A-A cross-sectional view of Figure 12 a, and Figure 12 c is the B-B cross-sectional view of Figure 12 a；

Figure 13 is the explosive view of the bilateral artificial cords implant system of the embodiment of the present invention two；

Figure 14 is to push the radial cross-section of conduit in the bilateral artificial cords implant system of Figure 13；

Figure 15 is the structural schematic diagram of the proximal end face of distal end collet in the bilateral artificial cords implant system of Figure 13；

Figure 16 is the A-A cross-sectional view of Figure 15；

Figure 17 is the B-B cross-sectional view of Figure 10；

Figure 18 is the explosive view of the bilateral artificial cords implant system of the embodiment of the present invention three；

Figure 19 is to push the axial sectional view of conduit in the bilateral artificial cords implant system of Figure 18；

Figure 20 and Figure 21 is the signal that clamping auxiliary member is stretched out from opening in the bilateral artificial cords implant system of Figure 18 Figure；

Figure 22 is to clamp auxiliary member in the bilateral artificial cords implant system of Figure 18 and clamp the structural representation of sub-arm Figure；

Figure 23 is the structural schematic diagram for clamping the another embodiment of auxiliary device；

Figure 24 is the structural schematic diagram for clamping the another embodiment of auxiliary device；

Figure 25 is the structural schematic diagram for clamping the another embodiment of auxiliary device；

Figure 26 to Figure 32 is shown using the process of the artificial cords implant system implantable artificial chordae tendineae of the embodiment of the present invention three It is intended to.

Specific embodiment

For a clearer understanding of the technical characteristics, objects and effects of the present invention, now control attached drawing is described in detail A specific embodiment of the invention.

Below for convenience, the bearing definition that will be close to operator is proximal end, and the bearing definition far from operator is Distally.

Embodiment one

As shown in Figures 3 to 12, bilateral artificial cords implant system of the invention is used to artificial cords 100 being implanted into patient In heart, the lesion chordae tendineae of mitral frontal lobe and rear leaf is replaced.Bilateral artificial cords implant system include clamping device 300, Sting device 400 and driving means 200.Driving means 200 includes push conduit 210.It is multiple along being axially arranged with to push conduit 210 The inner cavity of perforation.Clamping device 300 includes clamping push rod 330 and distal end collet 310 and proximal end folder for cooperating clamping leaflet First 320.The distal end of push conduit 210 is arranged in proximal end collet 320, and the distal end of clamping push rod 330 is arranged in distal end collet 310. Clamping push rod 330 is actively installed at the approximate centre axis of push conduit 210.Sting device 400 includes at least a pair of punctures Push rod 420 and the piercing needle 410 for being respectively arranged on puncture 420 distal end of push rod.It punctures push rod 420 and is actively installed on push conduit It is symmetrical set in 210 and about clamping push rod 330.The clamping device of bilateral artificial cords implant system of the invention as a result, 300 can clamp mitral frontal lobe and rear leaf simultaneously, then puncture push rod by being located at at least a pair of of clamping 330 two sides of push rod 420 drive piercing needles 410 puncture mitral frontal lobe and rear leaf respectively, and then realize the artificial cords implantation of bilateral.

It include a pair of of artificial cords 100 in the bilateral artificial cords implant system of embodiment one.Every artificial cords 100 are equal There is chordae tendineae main body 110 flexible including one section.Chordae tendineae main body 110 substitutes the lesion chordae tendineae in heart for being implanted into heart. Chordae tendineae main body 110 has opposite first end and second end.First end and/or second end are connected with fixing piece 120.Fixing piece 120 for sting device 400 it is non-dismountable be fixedly connected or be detachably fixed connect.

Chordae tendineae main body 110 can be fixed between leaflet and ventricle wall (or the positions such as papillary muscle), to substitute lesion Chordae tendineae maintains the tension between leaflet and ventricle wall.There is chordae tendineae main body 110 flexibility to refer to that it can be any in axial tensionless winkler foundation Bending, general chordae tendineae main body 110 use the form of flexible wires.The material of chordae tendineae main body 110 can be the high score compatible with human body Sub- material or more soft metal material etc..The high molecular materials such as preferably PTFE.

There is no the differences such as direction, significance level for the first end and second end of chordae tendineae main body 110.As shown in figure 5, fixing piece 120 can be provided only on one end of chordae tendineae main body 110, and the both ends of chordae tendineae main body 110 can also be arranged in as shown in Figure 6.This reality Apply the first end that fixing piece 120 in example is provided only on chordae tendineae main body 110.It can be used between chordae tendineae main body 110 and fixing piece 120 It knots, winding, weld, being bonded or the modes such as clamping are fixedly connected.For example, one end of chordae tendineae main body 110 can be pierced by fixation The ball of string being relatively large in diameter is formed by knots tied after part 120；Or end is welded as the ball being relatively large in diameter；Or A locating rod, the axial direction of locating rod in its natural state and chordae tendineae main body 110 is arranged in end again and the axial direction of fixing piece 120 is equal Not identical, after one end of locating rod and chordae tendineae main body 110 is passed through fixing piece 120, locating rod restores nature, that is, may be stuck in Thus one end of chordae tendineae main body 110 is fixed on fixing piece 120 by the back side of fixing piece 120.As shown in figure 5, due to chordae tendineae master The second end of body 110 is not provided with fixing piece 120, should pass through knotting, winding or setting bulbous end, plate-like end etc. The second end of chordae tendineae main body 110 is fixed on leaflet so that the diameter of second end is greater than the diameter of chordae tendineae main body 110 by mode Upper surface.

Fixing piece 120, which is used to be detachably fixed with the formation of the piercing needle 410 of sting device 400, to be connect or non-dismountable solid Fixed connection, shape cooperate different connection types.The outside of fixing piece 120 is usually cylindricality, and cross-sectional shape can be circle The various shapes such as shape, ellipse, polygon, circular or ellipse.

There are many connection types between fixing piece 120 and piercing needle 410, for example, being threadedly coupled, bonding, passing through slightly Matte frictional connection is interference fitted or snaps connection.As shown in figure 8, using snapping connection in the present embodiment, specifically solid The inner surface radial direction for determining part 120 sets that there are three between the convex edge 411 being arranged on groove or hole 125, with piercing needle 410 or protrusion Cooperation clamping, forms a fixed connection.Three grooves 125 both can guarantee the stabilization connected between fixing piece 120 and piercing needle 410 Property, reduce the shaking amplitude of piercing needle 410 after connection, the diameter that will not additionally increase piercing needle 410 leads to point of puncture Diameter increases.

Referring also to Fig. 5 and Fig. 6, in order to be increased to face contact for the point contact between artificial cords 100 and leaflet, from And the risk that artificial cords 100 tear leaflet is reduced, Non-slip material 130, and Non-slip material 130 are preferably arranged in chordae tendineae main body 110 It can sliding axially along chordae tendineae main body 110.Since Non-slip material 130 is set in advance in chordae tendineae main body 110, in piercing needle 410 puncture leaflets and after being fixedly connected with chordae tendineae main body 110, can drive Non-slip material 130 to point of puncture, and with chordae tendineae main body 110 are fixed in leaflet together.Specific set-up mode of the Non-slip material 130 in artificial cords 100 is: being arranged on Non-slip material 130 Through-hole 131, chordae tendineae main body 110 pass through through-hole 131.The setting quantity of through-hole 131 is related with the fixed form of Non-slip material 130.One Kind mode is one through-hole 131 of setting on Non-slip material 130, and chordae tendineae main body 110 passes through the through-hole 131 (as shown in Figure 5).It is another Mode is that at least two through-holes 131 are arranged on Non-slip material 130, and the first end and second end of a chordae tendineae main body 110 is each passed through Different through-holes 131 (as shown in Figure 6).Non-slip material 130 falls off from artificial cords 100 in order to prevent, and the diameter of through-hole 131 is small It should be by knotting or setting in the second end for being not provided with fixing piece 120 of the diameter of fixing piece 120, and chordae tendineae main body 110 The modes such as bulbous end, plate-like end are set, so that the diameter of second end is greater than the diameter of the through-hole 131 on Non-slip material 130 (as schemed Shown in 5).

In order to which active force of the chordae tendineae main body 110 to leaflet is dispersed to the contact surface between Non-slip material 130 and leaflet as far as possible, The needs of Non-slip material 130 are bonded as far as possible with leaflet, therefore Non-slip material 130 is equipped with the binding face 132 being bonded with leaflet.In addition to binding face Outside 132,130 specific structure of Non-slip material is not construed as limiting, and can have a variety of structures: for example can be sheet with certain area, Plate-like is spherical, even irregular shape, preferably sheet.Non-slip material 130 can be non-porous structure, be also possible to netted Structure, grating structure etc..Non-slip material 130 should be made of biocompatible materials, can be made of elastic material, can also be by Non-elastic material is made.Specifically, Non-slip material 130 is selected from elastomeric pad, cardiac patch, felt piece, network, disk-like structure Or at least one of double disk-like structures.The structure class of Non-slip material 130 wherein with disk-like structure or double disk-like structures It is similar to plugging device in the prior art, details are not described herein.Preferably, in order to reduce the overall dimensions of instrument, there is plate-like knot The Non-slip material 130 of structure or double disk-like structures should be made of shape-memory material.

As shown in fig. 7, Non-slip material 130 can also be not provided in chordae tendineae main body 110, as long as fixing piece 120 and piercing needle It forms a fixed connection, chordae tendineae main body 110 can also be fixed between leaflet and ventricle wall or papillary muscle between 410, replace lesion Chordae tendineae.

Referring again to Fig. 3 and Fig. 4, the main structure of driving means 200 is push conduit 210.Push conduit 210 be with The tubular body or rhabodoid of certain axial length, cross section is preferably circular, and circular diameter range is 10mm to 12mm. Push the inner cavity of the axially disposed multiple mutually separated perforations of conduit 210.Push conduit 210 can use integrally formed more Outer tube and inner tube suit can also be fixed together, form integrally-built push conduit 210 by lumen.Pushing conduit 210 can With the high molecular material using biocompatibility (for example, polyformaldehyde POM, polythene PE, nylon PA, polyvinylchloride, propylene Nitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU), metal material (for example, stainless steel or Person's Nitinol) or metal-polymer composite be made.The proximal end for pushing conduit 210 is equipped with first handle 201, is used for Manipulation push conduit 210 is withdrawn to distal end push or proximally.

It pushes in the inner cavity of conduit 210 and actively installs sting device 400.In order to realize mitral frontal lobe and rear leaf The implantation of bilateral artificial cords, sting device 400 include that at least a pair punctures push rod 420 and is respectively arranged on 420 distal end of puncture push rod Piercing needle 410.Every root puncture push rod 420 all has certain axial length, and two root puncture push rods 420 are pushed away about clamping Bar 330 (that is, central axis of push conduit 210) is symmetrical set.Piercing needle 410 can be with artificial cords after puncturing leaflet 100 fixing piece 120 connects, and chordae tendineae main body 100 is pulled to proximal end.

The distal end of piercing needle 410 is the straight tip of taper, in favor of puncturing leaflet and reducing what it was formed in leaflet Puncture spot diameter.Leaflet is passed through using the syringe needle with hook-shaped head end in the prior art, and hooks the suture being taken as artificial cords Line, syringe needle of then dropping back drives artificial cords to pass through leaflet, then artificial cords are fixed in ventricle wall, this to have hook-shaped head The point of puncture that the syringe needle at end is formed in leaflet is bigger than normal, larger to leaflet damage, not only influences the process of patient's post-operative recovery, also It will increase the risk that leaflet is torn.And the point of puncture that the straight tip of taper is formed in leaflet is small, postoperative conducive to patient is cured It closes.The diameter range for the single point of puncture that the bilateral artificial cords implant system of the present embodiment is formed in every leaflet is 0.3mm to 1.5mm, further, by selecting the shape and diameter of suitable piercing needle 410, the controlled diameter of point of puncture It is made as about 0.7mm.

The distal portion of piercing needle 410 is equipped with for forming interference fit with fixing piece 120 or snapping connection at least One double wedge or at least one circle convex edge 411.It is understood that in other embodiments, piercing needle 410 can also pass through It is formed between the modes such as screw thread, bonding, frictional connection and the fixing piece 120 of artificial cords 100 non-dismountable or dismountable It is fixedly connected.410 proximal end of piercing needle, which is connected with, punctures push rod 420, punctures push rod 420 and is actively installed on push conduit 210 Inner cavity in.The proximal end for puncturing push rod 420 is pierced by and is connected with third handle 401 from push 210 proximal end of conduit.Pass through as a result, The axial movement of third handle 401 can drive and puncture push rod 420 along the axial movement of push conduit 210, and then drive and puncture Syringe needle 410 is punctured to distal end or is proximally withdrawn.After leaflet is clamped the clamping of device 300, piercing needle 410 can be in third Under handle 401 drives, pierces through leaflet and connect with the fixing piece of artificial cords 100 120, piercing needle 410 and artificial cords 100 An entirety is connected to become by fixing piece 120.The syringe needle with hook-shaped head end of the prior art hooks the probability for taking artificial cords It is relatively low, it causes success rate of operation relatively low, extends operating time；And after syringe needle catches on artificial cords, due to syringe needle and people It is only connected by faint frictional force between work chordae tendineae, during dropping back syringe needle, since blood stream of patients washes away or operates The movement of person easily leads to artificial cords and falls off from syringe needle, extends operating time, or even cause operative failure.And this implementation Example piercing needle 410 and artificial cords 100 chordae tendineae main body 110 pass through fixing piece 120 formed it is reliable and stable be indirectly connected with, So that artificial cords 100 are not easy to be detached from piercing needle 410, operator can be conveniently and efficiently by artificial cords 100 and fixing piece 120 connected one or both ends are pulled to the predetermined position of ventricle wall or papillary muscle.

Clamping device 300 can clamp mitral frontal lobe and rear leaf simultaneously.Clamping device 300 includes clamping push rod 330, remote Hold collet 310 and proximal end collet 320.Clamping push rod 330 is actively installed at the approximate centre axis of push conduit 210.Proximal end The distal end of push conduit 210 is arranged in collet 320.The distal end of clamping push rod 330 is arranged in distal end collet 310.Clamp push rod 330 Proximal end from push conduit 210 proximal end be pierced by and second handle 301 be set.Second handle 301, band are pushed to distal end as a result, Dynamic clamping push rod 330 is mobile to distal end, so that distal end collet 310 forms opening shape as shown in Figure 3 far from proximal end collet 320 State forms the leaflet accommodation space of hollow cylindrical between distal end collet 310 and proximal end collet 320 at this time, can accommodate simultaneously Mitral frontal lobe and rear leaf.The adjustable instrument distal end of operator makes mitral frontal lobe and rear leaf while entering distal end Then leaflet accommodation space between collet 310 and proximal end collet 320 proximally withdraws second handle 301, drive clamping push rod 330 move to the near end, so that proximally collet 320 is close for distal end collet 310, form clamp position as shown in Figure 4, at this point, Mitral frontal lobe and the clamped device 300 of rear leaf are clamped and are fixed.Proximal end collet 320 and the shape of distal end collet 310 are answered Consistent with the shape cooperation of push conduit 210, distal end collet 310 and proximal end collet 320 should form smooth in appearance after closure It is whole, in order to push and mitigate the damage to patient wound.It is understood that above-mentioned push second handle to distal end 301 make distal end collet 310 far from the state of proximal end collet 320, can also be by proximally withdrawing first handle 201 and push Conduit 210 reaches；Proximally recession second handle 301 makes distal end collet 310 close to the state of proximal end collet 320, can also By reaching to distal end push first handle 201 and push conduit 210.

In order to improve the stability of clamping, the clamping face (that is, distal face of proximal end collet 320) of proximal end collet 320 and remote The clamping face (that is, proximal end face of distal end collet 310) of end collet 310 should be bonded to each other, and be respectively provided with biggish leaflet and connect Contacting surface product.The proximal end face of distal end collet 310 is preferably provided with as the clamping face contacted with leaflet by distally proximally protruding Conical surface；And the distal face of proximal end collet 320 is as the clamping face contacted with leaflet, is preferably provided with as by distally proximally Recessed conical surface, and its shape is matched with the conical surface of the proximal end face of distal end collet 310.In addition, distal end presss from both sides First 310 and/or the clamping face of proximal end collet 320 be equipped with clamping reinforcement for enhancing chucking power.It is preferred to clamp reinforcement For at least one of protrusion, fin, groove or pit, and the folder of proximal end face (that is, clamping face) setting of distal end collet 310 The shape for holding reinforcement should be mutual with the shape of the clamping reinforcement of the distal face (that is, clamping face) of proximal end collet 320 setting Cooperate, so that very close to each other between the distal end collet 310 and proximal end collet 320 after closure.In the present embodiment, distal end collet 310 Clamping face and the clamping face of proximal end collet 320 on a plurality of parallel fin is respectively set as clamping reinforcement, when distal end presss from both sides First 310 and proximal end collet 320 be closed after, therebetween it is very close to each other.

As shown in figure 9, clamping push rod 330 is that tubular body with certain axial length or hollow rod shape body, cross section are excellent It is selected as ellipse or round, and clamps edge in push rod 330 and is axially arranged with artificial cords channel 331.As shown in figs. 10-11, far The artificial cords accommodating chamber 315 and 315 ' being connected respectively with artificial cords channel 331 there are two being set in the collet 310 of end, manually Chordae tendineae accommodating chamber 315 and 315 ' is penetrated through to the proximal end face of distal end collet 310, and artificial cords accommodating chamber 315 and 315 ' about Clamping push rod 330 (that is, central axis of push conduit 210) is symmetrical set.That is, the distal end bifurcated in artificial cords channel 331 is Y Type, the Liang Ge branch of Y type bifurcated is respectively as artificial cords accommodating chamber 315 and 315 '.The chordae tendineae main body of a piece artificial cords 100 110 are contained in artificial cords channel 331 and artificial cords accommodating chamber 315, the chordae tendineae main body 110 of another artificial cords 100 It is contained in artificial cords channel 331 and artificial cords accommodating chamber 315 '.

The proximal end face of distal end collet 310 sets consolidating there are two the fixing piece 120 for being respectively used to two artificial cords 100 of accommodating Determine chamber 313 and 313 ', and lock chamber 313 and 313 ' is in symmetrical about clamping push rod 330 (that is, central axis of push conduit 210) Setting.It is axially connected between lock chamber 313 and artificial cords accommodating chamber 315；Lock chamber 313 ' and artificial cords accommodating chamber 315 ' Between be axially connected to.The position of two lock chambers 313 and 313 ' and the position of two piercing needles 420 respectively correspond.As a result, two Two fixing pieces 120 of artificial cords 100 are respectively contained in distal end collet 310, and the proximal end difference of each fixing piece 120 Corresponding to a piercing needle 410.Preferably, the proximal end face of distal end collet 310 be ellipse, and two lock chambers 313 and 313 ' are respectively positioned on elliptical long axis, to adapt to shape when mitral two panels leaflet closure.

It is understood that in other embodiments, lock chamber 313 and 313 ' can also be located at elliptical other positions, As long as two lock chambers 313 and 313 ' are symmetrical set, as shown in Figure 12 a-12c.

Artificial cords are exposed to outside instrument by the prior art, so that instrument outer surface is rough, instrument are caused to enter people When body, frictionally damage is caused to tissue, while leakage blood occur, increases the risk that patient generates postoperative complications.And this implementation Artificial cords 100 can be placed and secured in inside instrument by the lock chamber 313 of example, avoid foregoing problems.In addition, the prior art In, the artificial cords being implanted into such a way that U-shaped ring set combines hook-shaped syringe needle will cause the fold of leaflet valve edge, make the portion of leaflet Position forms artificial notch, can not form pairing edge, be easy to cause mitral reflux, surgical effect is undesirable.The present embodiment provides Bilateral artificial cords implant system, lock chamber 313 and clamping the distance between push rod 330 be artificial cords after being implanted into The spacing at leaflet edge can effectively avoid leaflet edge fold, enhance surgical effect.

Due to being additionally provided with Non-slip material 130 in artificial cords 100, the proximal end face of distal end collet 310 sets that there are two respectively For accommodating the container 314 and 314 ' of the Non-slip material 130 of two artificial cords 100, and container 314 and 314 ' is about clamping Push rod 330 (that is, central axis of push conduit 210) is symmetrical set.Diameter between container 314 and artificial cords accommodating chamber 315 To connection, radial communication between container 314 ' and artificial cords accommodating chamber 315 '.Diameter between container 314 and lock chamber 313 To connection.Radial communication between container 314 ' and lock chamber 313 '.Two points are punctured respectively in two piercing needles 410 as a result, The frontal lobe of valve and rear leaf and after connecting respectively with a fixing piece 120, can pass through proximally that recession respectively is a pair of to puncture push rod 420, drive two piercing needles 410 and respectively coupled fixing piece 120, chordae tendineae main body 110 and Non-slip material 130 successively by The proximal end face of distal end collet 310 is drawn out, until piercing needle 410, fixing piece 120 and the chordae tendineae main body 110 of side are successively worn Cross mitral frontal lobe, Non-slip material 130 conforms to the upper surface of mitral frontal lobe, and the piercing needle 410 of the other side, fixed Part 120 and chordae tendineae main body 110 sequentially pass through mitral rear leaf, and Non-slip material 130 conforms to the upper surface of mitral rear leaf, complete It is implanted at the artificial cords of mitral bilateral leaflet.

The setting of lock chamber and container may be implemented in the premise that need not unclamp distal end collet 310 and proximal end collet 320 It is lower that chordae tendineae main body 110 and Non-slip material 130 are pulled to leaflet, therefore by closed form between distal end collet 310 and proximal end collet 320 When state is converted to open configuration, leaflet is detached from from clamping device 300, the moment of preparatory stroke, and chordae tendineae main body 110 will not be with valve Leaf individually contacts, and the linear incision effect of chordae tendineae main body 110 is avoided to generate injury to the leaflet of beating.

It is with the lock chamber 313, container 314 and the artificial cords accommodating chamber 315 that are located at clamping 330 side of push rod below Example illustrates the size setting of three.The size of lock chamber 313 should make the fixing piece 120 of artificial cords 100 that can both be fixed In lock chamber 313, it can successfully be pulled out out of lock chamber 313 again after fixing piece 120 is by external force drawing.Therefore, Gu The shape for determining chamber 313 is matched with the shape of fixing piece 120, and the inscribe diameter of a circle of lock chamber 313 is received greater than artificial cords The external diameter of a circle of cavity 315.Preferably, the inscribe of the external diameter of a circle of artificial cords accommodating chamber 315 and lock chamber 313 The ratio between diameter of a circle is (0.2~0.4): 1.When the cross section of lock chamber 313 and artificial cords accommodating chamber 315 is circle, The inscribe diameter of a circle of lock chamber 313 is the diameter of the circular cross section of lock chamber 313, artificial cords accommodating chamber 315 it is outer Connect the diameter that diameter of a circle is the circular cross section of artificial cords accommodating chamber 315.In the present embodiment, lock chamber 313 it is transversal Face is circle, and a diameter of D1, the cross section of artificial cords accommodating chamber 315 is round, a diameter of D2, and D2 is D1 30%.The purpose of such setting is: if D2 is excessive, piercing needle 410 puncture push rod 420 promotion under with artificial cords 100 Fixing piece 120 when cooperating, due to puncturing the thrust to distal end of push rod 420, fixing piece 120 may slide out of lock chamber 313 It takes off in artificial cords accommodating chamber 315, causing cannot be disposable between piercing needle 410 and the fixing piece of artificial cords 100 120 It is successfully connected, extends operating time；If D2 is too small, the chordae tendineae main body 110 of artificial cords 100 cannot be from artificial cords accommodating chamber It is passed through in 315, it, cannot be by artificial cords 100 after causing piercing needle 410 to connect with the fixing piece 120 of artificial cords 100 Smoothly pull out the clamping face of distal end collet 310.It is understood that in other embodiments, lock chamber 313 and artificial cords are received The cross section of cavity 315 can also be the other shapes such as ellipse, triangle, quadrangle, polygon, as long as lock chamber 313 Shape and the shape of fixing piece 120 cooperate, and the shape of artificial cords accommodating chamber 315 does not influence chordae tendineae main body 110 at it In it is smooth by.

In order to which chordae tendineae main body 110 and Non-slip material 130 successfully to be pulled out to the clamping face of distal end collet 310, lock chamber 313 The radial communication between container 314.Preferably, the width D 3 of the connected component between lock chamber 313 and container 314 is D1 20%-50%, the purpose of such setting is: if D3 is excessive, the fixing piece 120 of artificial cords 100 cannot be firmly fixed In the lock chamber 313 of distal end collet 310, it is easy to slip out of lock chamber 313, directly results in device failure；If D3 is too small, It, cannot be swimmingly by fixing piece 120 from lock chamber after piercing needle 410 is connect with the fixing piece 120 of artificial cords 100 It is pulled out in 313, leads to operative failure.

It is received it is understood that being located at the lock chamber 313 ' of clamping 330 other side of push rod, container 314 ' and artificial cords The size setting of cavity 315 ' and the size of lock chamber 313 above-mentioned, container 314 and artificial cords accommodating chamber 315 are set up Exactly the same, details are not described herein.

Bilateral artificial cords implant system provided in this embodiment compared with prior art, at least has below beneficial to effect Fruit:

(1) piercing needle uses the pyramidal structure with straight tip, and piercing needle diameter is smaller, and what is formed in leaflet wears Thorn point is smaller, mitigates the damage to leaflet, accelerates the postoperation recovery process of patient；

Both (2) piercing needle and the fixing piece of artificial cords are realized by clamping device positions, can effectively improve Cooperation probability, so as to shorten operating time；

(3) piercing needle and artificial cords can be formed it is reliable and stable be indirectly connected with so that artificial cords are not easy and puncture Syringe needle is detached from, and artificial cords are conveniently and efficiently pulled to fixed position；

(4) clamping push rod is arranged at the approximate centre axis of push conduit, and at least a pair of push rod that punctures is about clamping push rod It is symmetrical set, mitral frontal lobe and rear leaf can be clamped simultaneously by the relative motion between proximal end collet and distal end collet, And then the implantable artificial chordae tendineae in mitral frontal lobe and rear leaf simultaneously, it greatly shortens operating time, improves procedure efficiency.

Embodiment two

The structure of the bilateral artificial cords implant system of embodiment two and the bilateral artificial cords implant system of embodiment one Structure it is essentially identical, difference place be, in the bilateral artificial cords implant system of embodiment two, sting device include two pairs It punctures push rod and is respectively arranged on the piercing needle for puncturing push rod distal end, and the artificial cords of the structure of artificial cords and embodiment one Structure it is different.

Specifically, as shown in figure 13, in the bilateral artificial cords implant system of embodiment two, sting device 400 includes two Piercing needle 410 to push rod 420 is punctured and set on every 420 distal end of root puncture push rod.Two artificial cords 100 are respectively contained in It clamps in push rod 330, and every artificial cords 100 are all made of the form of Fig. 6, i.e. the both ends of chordae tendineae main body 110 are equipped with fixation Part 120.

Referring to Figure 14, pushes and four puncture push rod channels 202 are set in conduit 210, it is living in each puncture push rod channel 202 A root puncture push rod 420 is installed dynamicly.As a result, every two root punctures push rod 420 be a pair, set on push conduit 210 side (with It is known as " the first side " down), another two are used as another pair, (hereinafter referred to as set on the other side opposite with the first side of push conduit 210 For " second side "), and two root puncture push rods 420 of every centering are symmetrical set about the central axis of push conduit 210.In order to just The same handle 401 is connected in the proximal end of operation, two root puncture push rods 420 of every centering.

Clamping push rod 330 is actively installed in the clamping push rod channel 203 of push conduit 210, and is located at approximate centre At axis, four root puncture push rods 420 are symmetrical set about clamping push rod 330 as a result,.Clamp axially disposed people in push rod 330 Work chordae tendineae channel 331.Two artificial cords 100 are contained in the artificial cords channel 331 of clamping push rod 330.Four fixations Part 120 is arranged in distal end collet 310, and corresponds respectively to four piercing needles 410 of four root puncture push rods, 420 distal end.

As seen in figs. 15-17, the people of the clamping face to distal end collet 310 is penetrated through there are four setting in distal end collet 310 respectively Work chordae tendineae accommodating chamber 315, and four artificial cords accommodating chambers 315 about clamping push rod 330 (that is, push conduit 210 center Axis) it is symmetrical set, that is, in four artificial cords accommodating chambers 315, every two is a pair, set on the side of distal end collet 310 (hereinafter referred to as " the first side "), another two as another pair, set on distal end collet 310 the other side opposite with the first side (with It is known as " second side " down).The distal end of each artificial cords accommodating chamber 315 is axially connected with a lock chamber 313, each artificial The ratio between the diameter D2 of chordae tendineae accommodating chamber 315 and the coupled diameter D1 of lock chamber 313 range are (0.2~0.4): 1.

The radial communication between two lock chambers 313 of the first side, the diameter between two lock chambers 313 of second side To connection.The radial communication between two artificial cords accommodating chambers 315 of the first side, positioned at two artificial cords of second side Radial communication between accommodating chamber 315.The chordae tendineae main body 110 of a piece artificial cords 100 is contained in artificial cords channel 331 and is located at In two artificial cords accommodating chambers 315 of 310 first side of distal end collet, the chordae tendineae main body 110 of another artificial cords 100 is accommodated In artificial cords channel 331 and in two artificial cords accommodating chambers 315 of 310 second side of distal end collet.That is, every chordae tendineae The first end and second end of main body 110 are after artificial cords channel 331 is pierced by respectively through being located at the two of 310 the same side of distal end collet A artificial cords accommodating chamber 315 is pierced by and is connected respectively with a fixing piece being placed in lock chamber 313 120.

As a result, when operator to four root puncture push rods 420 are distally pushed respectively, positioned at four root puncture push rods, 420 distal end After four piercing needles 410 puncture mitral frontal lobe and rear leaf respectively, positioned at the first side two piercing needles 410 respectively with Two fixing pieces 120 positioned at the first side are connected, and two piercing needles 410 positioned at second side are respectively and positioned at the two of second side A fixing piece 120 be connected so that a chordae tendineae main body 110 and set on 110 both ends of this chordae tendineae main body two fixing pieces 120 and Two piercing needles 410 form U-shaped structures, another chordae tendineae main body 110 and solid set on two of 110 both ends of this chordae tendineae main body Determine part 120 and two piercing needles 410 also form U-shaped structure, operator proximally drops back four root puncture push rods 420 later, can Two chordae tendineae main bodys 110 are driven to be drawn out respectively from the proximal end face of distal end collet 310, a part point of two chordae tendineae main bodys 110 The upper surface of mitral frontal lobe and rear leaf is not conformed to, and the rest part of chordae tendineae main body 110 then follows fixing piece 120 and punctures Syringe needle 410 is each passed through frontal lobe and rear leaf until reaching the predetermined position of ventricle wall or papillary muscle.Therefore the bilateral people of the present embodiment Work chordae tendineae implant system quickly and easily can be implanted into four between mitral frontal lobe and rear leaf and ventricle wall or papillary muscle respectively Root artificial cords 100, and chordae tendineae main body 110 is avoided to cause leaflet to be damaged the vertical cutting effect of leaflet.

Non-slip material 130 is additionally provided in artificial cords 100 in the present embodiment.Referring again to Fig. 6, the Non-slip material 130 of sheet At least two through-holes 131 of upper setting, the first end and second end of the chordae tendineae main body 110 of an artificial cords 100 is each passed through anti- It is connected after one of through-hole 131 of saddle 130 with a fixing piece 120.As a result, before puncture, chordae tendineae main body 110 and anti-skidding Part 130 forms the closed state of annular.After piercing, Non-slip material 130,110, two fixing pieces 120 of chordae tendineae main body and two wear The U-shape state of the formation open loop of pricker head 410.And chordae tendineae main body 110 pushes down Non-slip material 130 and Non-slip material 130 is made to be tightly attached to leaflet Upper surface, the relative position between chordae tendineae main body 110 and Non-slip material 130 and leaflet is substantially stationary, avoids the chordae tendineae main body of implantation 110 cause leaflet to tear.

Referring again to Figure 15-17, the proximal end face of distal end collet 310 is also provided with two receipts for accommodating Non-slip material 130 Tank 314, two containers 314 are symmetrical set about clamping push rod 330 (that is, central axis of push conduit 210).Positioned at remote It holds two lock chambers 313 of the first side of collet 310 respectively with the radial communication between the container 314 of the side, is located at remote Hold collet 310 second side two lock chambers 313 respectively be located at the side container 314 between radial communication.It wears as a result, 110, two fixing pieces 120 of chordae tendineae main body for being located at the same side and Non-slip material 130 can be pulled out distal end collet 310 together after thorn Proximal end face.Preferably, the width D 3 of the connected component between the lock chamber 313 and container 314 of every side is 313 diameter of lock chamber The 20%-50% of D1.

The bilateral artificial cords implant system of the present embodiment compared with prior art, at least has the advantages that

(1) more artificial cords quickly can be implanted into mitral frontal lobe and rear leaf simultaneously, improve procedure efficiency；

(2) not only the point contact of artificial cords and leaflet can be increased to by face contact by Non-slip material, but also can kept away The end of manpower-free's chordae tendineae falls off from Non-slip material and leaflet, more efficiently maintains surgical effect；

(3) Non-slip material is close to the upper surface of leaflet by chordae tendineae main body, consolidating between chordae tendineae main body and Non-slip material and leaflet Determine the risk that mode is relatively firm reliable, and leaflet tearing or chordae tendineae main body and Non-slip material is effectively avoided to fall off from leaflet surface, Surgical effect is preferable.

Embodiment three

The structure of the bilateral artificial cords implant system of embodiment three and the bilateral artificial cords implant system of embodiment two Structure it is essentially identical, difference place be, further include in the bilateral artificial cords implant system of embodiment three clamping auxiliary dress It sets.

Specifically, referring to Figure 18, bilateral artificial cords implant system includes clamping device 300, sting device 400, push Device 200 and clamping auxiliary device 500.The clamping push rod 330 of clamping device 300 is located at the approximate centre axis of push conduit 210 Place.Clamping auxiliary device 500 includes at least a pair of clamping sub-arm 520 being actively threaded onto push conduit 210 and difference Clamping auxiliary member 510 set on clamping 520 distal end of sub-arm.Each pair of clamping sub-arm 520 is about clamping push rod 330 (that is, push The central axis of conduit 210) it is symmetrical set.In order to facilitate push, in clamping also settable 4th handle in 520 proximal end of sub-arm 501.In the present embodiment, a pair of of clamping sub-arm 520 is set, two clamping sub-arms 520 are actively installed on push conduit 210 In and about clamping push rod 330 be symmetrical set, it is each clamping sub-arm 520 distal end be equipped with clamping auxiliary member 510.

As shown in Figure 19-21, edge is axially arranged with sub-arm accommodating chamber 250 in push conduit 210.Before puncture, folder It holds auxiliary member 510 and clamping sub-arm 520 is all housed in sub-arm accommodating chamber 250.On the distal face of proximal end collet 320, The side wall of the side wall or proximal end collet 320 that push conduit 210 is provided with opening 260, opening 260 and sub-arm accommodating chamber 250 It connects.When operator pushes the 4th handle 501 to distal end, clamping sub-arm 520 can be driven to push clamping auxiliary member 510 from opening It is pierced by mouth 260, to be supported on the lower surface of leaflet, stablizes the leaflet of beating, reduce the movable amplitude of leaflet, filled with clamping 300 cooperations are set to clamp and fix leaflet.

Preferably, the angular range between the axial direction of 250 distal portion of sub-arm accommodating chamber and the axial direction for pushing conduit 210 is 120-150°.The reason of being arranged in this way is, before puncture, clamping push rod 330 and leaflet EDGE CONTACT, distal end collet 310 and proximal end Collet 320 is only capable of clamping part leaflet, need to be in every leaflet 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 support force is provided, it is therefore desirable to make to clamp auxiliary member 510 and push have one between conduit 210 Clamp angle can be supported on the lower surface of the other side opposite with leaflet edge of every leaflet.

As shown in figs. 22-23, clamping auxiliary member 510 is supported on leaflet lower surface and cooperates clamping valve with clamping device 300 Leaf.Clamping auxiliary member 510 is made of elasticity and/or flexible material, to adapt to the anatomical structure of leaflet and the movable amplitude of leaflet, And avoid damage to leaflet.Elastic material is preferably shape-memory material.Clamping auxiliary member 510 can be by metal material, polymer Material or Metal polymer composite are made.It is a rhabodoid that auxiliary member 510 is clamped in the present embodiment.Rhabodoid can Think that the solid or hollow structure of single layer perhaps multi-layer compound structure can also be formed by individual thread or multi-filament coiling.Bar The section of shape body can be regular circle or the shapes such as ellipse, crescent, partially circular, polygonal.Clamp auxiliary member 510 Smooth-shaped distally forms smooth round end by laser spot welding, the defects of without burr, seamed edge or corner angle.In the present embodiment, Clamping auxiliary member 510 is made of the elastic Nitinol with shape memory function, and cross section is circle.

Clamping sub-arm 520 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 520 can be by the hollow or solid construction of single layer or multi-layer compound structure Metallic rod or high molecular material bar are made, and can also be formed by individual thread or multi-filament coiling.Clamp the section of sub-arm 520 It can be regular circle or ellipse, crescent, the partially circular, polygonal or shapes such as annular.Clamping sub-arm 520 can To be made of metal material, polymer material or Metal polymer composite.In the present embodiment, clamping sub-arm 520 by Elastic material with memory function forms, and section is circle.

The flexibility of the supportive and clamping auxiliary member 510 that clamp sub-arm 520 can be by using different material point Clamping auxiliary member 510 and clamping sub-arm 520 is not made to reach.That is, clamping sub-arm 520 is made of hard material；Clamping Auxiliary member 510 is made of elasticity and/or flexible material.It is understood that can also be first using identical material production folder Sub-arm 520 and clamping auxiliary member 510 are held, then externally and/or internally adds the higher material of hardness in clamping sub-arm 520 Expect to serve as a contrast silk as reinforced pipe or stiffened to guarantee the supportive of clamping sub-arm 520.As shown in figure 23, sub-arm 520 is clamped It is made of relatively soft inner tube 521 and harder outer tube 522.

Preferably, clamping auxiliary member 510 is made by not transmiting X-ray material.In the prior art, in gripping means grips 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, it must Accurately ultrasonic guidance, which must be relied on, could be moved to clamping device suitable position, and pass through the beating shape of ultrasound observation leaflet State drives rapidly the relative motion between distal end collet and proximal end collet to clamp valve when leaflet is beaten to close to clamping device Leaf.Ultrasound has higher requirement to the operating technology of doctor and the analysis ability of cardiac ultrasound images, leads to cost increasing of performing the operation Add, operating difficulty increases, and operating time increases.Since the clamping auxiliary member 510 of the present embodiment is not by transmiting X-ray material system At after clamping auxiliary member 510 is contacted with leaflet, flexible and/or elasticity the auxiliary member 510 that clamps is with the movable amplitude of leaflet Corresponding swing is generated, therefore before clamping device 300 clamps leaflet, operator can be by X-ray rapidly and accurately Judge the position of leaflet, so that more rapidly accurately operation clamping device 300 reduces 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 auxiliary device 500, clamping auxiliary member 510 can also be the distressed structure being made of plurality of rods shape body.It is received jointly after distressed structure contraction distortion with clamping sub-arm 520 It is dissolved in push conduit 210.For example, distressed structure is the open bifurcation structure or umbrella knot being made of plurality of rods shape body Structure.For the ease of being pushed in push conduit 210, clamping auxiliary member 510 has stretching, extension when compressive state and nature State.Auxiliary member 510 is clamped in compressive state, can be housed in the sub-arm accommodating chamber 250 of push conduit 210 and be pushed away It send；When clamping auxiliary member 510 is by being set to the clamping face of proximal end collet 320, pushing the side wall or proximal end collet 320 of conduit 210 Side wall opening 260 in stretch out after, be changed into extended state, may be supported on the lower surface of leaflet, stablize the leaflet of beating.This The contact surface of clamping auxiliary member 510 and leaflet that kind is relatively large in diameter is the plane for clamping 510 place of auxiliary member, therefore, clamping Contact area between auxiliary device 500 and leaflet is bigger, can preferably be bonded leaflet, and it is right to improve clamping auxiliary device 500 The supportive of leaflet.

It will also be appreciated that in other embodiments, the end of the clamping auxiliary member 510 of bifurcation structure or umbrella-shaped structure End can form a depressed area to clamping 520 proximal direction turnup of sub-arm, multiple clamping auxiliary members 510, as shown in figure 24. At this point, due to the inside turnup in each 510 end of clamping auxiliary member and being directed toward clamping 520 proximal direction of sub-arm, folder can avoid Stab leaflet or ventricle wall in the support rod end for holding auxiliary member 510.

It will also be appreciated that in other embodiments, distressed structure can also be the closed loop being made of more support rods Structure, closed loop configuration can be circle, diamond shape, ellipse, pyriform, polygon or other are irregular but can form closing knot The shape of structure, as shown in figure 25.It can be with it will also be appreciated that in other embodiments, between the support rod of closed loop configuration At least one is arranged, and there is flexible and/or elasticity connecting rod to further enhance folder to improve the self stability of closed loop configuration Auxiliary member 510 is held to the support force of leaflet.It will also be appreciated that in other embodiments, it is more when being arranged in closed loop configuration When root support rod and connecting rod, closed loop configuration can also form laminated structure or reticular structure.It will also be appreciated that at other In embodiment, thermal finalization processing can also be carried out to reticular structure, reticular structure is made to form the disk-like structure (class of stretchable deformation It is similar to single-deck plugging device in the prior art), disk-like structure further thermal finalization processing can form column, nido, oblate shape Etc. structures.As long as clamping auxiliary member 510 is made of shape-memory material, the sub-arm receiving of push conduit 210 can be housed in It in chamber 250 and is conveyed, then is stretched out by opening 260, restored to natural unfolded state, with leaflet following table face contact and to leaflet Support is provided.

Below by taking the bilateral artificial cords implantation that mitral frontal lobe and rear leaf clamp simultaneously as an example, illustrate the present embodiment The implementation process of the bilateral artificial cords implant system of offer:

The first step, referring to fig. 26, bilateral artificial cords implant system is passed through into bicuspid valve and is advanced into left ventricle；

Second step, referring to fig. 27, continue to promote bilateral artificial cords implant system until distal end collet 310 and proximal end collet 320 are respectively positioned in atrium sinistrum, push second handle 301 to distal end, second handle 301 drives clamping push rod 330 relative to push Conduit 210 is mobile to distal end, positioned at distal end collet 310 and the proximal end positioned at push 210 distal end of conduit of clamping 330 distal end of push rod Collet 320 separates, and forms the leaflet accommodation space of hollow cylindrical between proximal end collet 320 and distal end collet 310 at this time；

Third step, referring to fig. 28, the 4th handle 501 is pushed to distal end, the 4th handle 501 driving clamping sub-arm 520 pushes away Send clamping auxiliary member 510 from opening 260 in be pierced by, at this time two clamping auxiliary members 510 be respectively supported at mitral frontal lobe with Leaf lower surface is afterwards to assist to stablize the leaflet beaten, and the relative position between holding first handle 201 and second handle 301 is not Become, proximally slowly move entire instrument, until mitral frontal lobe and rear leaf enter proximal end collet 320 and distal end collet In leaflet accommodation space between 310, two clamping auxiliary members 510 can provide mitral frontal lobe and rear leaf respectively at this time Certain support force；

4th step, referring to fig. 29, the distal end of bilateral artificial cords implant system is finely tuned, until mitral frontal lobe and rear leaf Edge contacted with clamping push rod 330, second handle 301 of proximally dropping back at this time, driving distal end collet 310 proximally collet 320 is mobile until the two closure, mitral frontal lobe and rear leaf are clamped；

5th step pushes third handle 401 to distal end, drives axis of four piercing needles 410 respectively along push conduit 210 To mobile to distal end collet 310, until four piercing needles 410 are each passed through mitral frontal lobe and rear leaf, and respectively with set It sets and forms a fixed connection between four fixing pieces 120 in distal end collet 310；

6th step, referring to Figure 30, third handle 401 of dropping back, so that piercing needle 410 drives fixing piece 120 and fixing piece 120 connected chordae tendineae main bodys 110 sequentially pass through leaflet, and Non-slip material 130 is also drawn out from the proximal end face of distal end collet 310, and two The binding face (that is, lower surface) of Non-slip material 130 is contacted with the upper surface of mitral frontal lobe and rear leaf respectively, while every chordae tendineae The upper surface that main body 110 pushes down two Non-slip materials 130 respectively makes it be bonded mitral frontal lobe and rear leaf respectively (such as Figure 31 institute Show), at this point, the point contact between artificial cords 100 and leaflet is converted into the face contact between Non-slip material 130 and leaflet, it can The risk of the tearing of leaflet 900 is effectively reduced；

7th step, referring to Figure 31, the third handle 401 that continues to drop back is until fixing piece 120 is removed from the proximal end of push conduit 210 Out, the 4th handle 501 of recession drives clamping auxiliary member 510 to withdraw into sub-arm accommodating chamber 250, it is artificial to withdraw from entire bilateral Chordae tendineae implant system, and the length for staying in the chordae tendineae main body 110 in heart is adjusted, the both ends of chordae tendineae main body 110 are fixed respectively In ventricle wall or the predetermined position of papillary muscle, as shown in figure 32, the bilateral artificial cords for completing mitral frontal lobe and rear leaf are planted Enter.

It, at this time can be with fine adjustment of remote collet 310 and proximal end if operator has found that leaflet is not clamped effectively in the 4th step The relative position of collet 320 to generate certain distance therebetween, then adjusts the opposite position between clamping push rod 330 and leaflet It sets, operates clamping device 300 again to clamp leaflet, then carry out the surgical procedure of the 5th step.During adjustment, due to valve Clamping auxiliary device 500 below leaf has certain supporting role to leaflet, and leaflet can be prevented sliding from clamping device 300 It is de-.

To sum up, bilateral artificial cords implant system of the invention due to will clamp push rod be arranged in push conduit substantially in At mandrel, and at least a pair of push rod setting will be punctured in push conduit and will be symmetrical arranged about clamping push rod, therefore by close Relative motion between end collet and distal end collet can clamp mitral frontal lobe and rear leaf simultaneously, and then simultaneously mitral Frontal lobe and rear leaf implantable artificial chordae tendineae greatly shorten operating time, improve procedure efficiency.

The foregoing is merely illustrative of the preferred embodiments of the present invention, is not intended to limit the invention, all in essence of the invention Made any modifications, equivalent replacements, and improvements etc., should all be included in the protection scope of the present invention within mind and principle.

Claims

1. bilateral artificial cords implant system, including clamping device, sting device and driving means, the driving means includes pushing away Conduit is sent, for the push conduit along the inner cavity for being axially arranged with multiple perforations, the clamping device includes clamping push rod and for matching Co-clip holds the distal end collet and proximal end collet of leaflet, and the distal end of the push conduit, the distal end is arranged in the proximal end collet The distal end of the clamping push rod is arranged in collet, which is characterized in that the clamping push rod is actively installed on the push conduit Approximate centre axis at, the sting device include at least it is a pair of puncture push rod and be respectively arranged on described puncture wearing for push rod distal end Pricker head, the puncture push rod are actively installed in the push conduit and are symmetrical set about the clamping push rod.

2. bilateral artificial cords implant system according to claim 1, which is characterized in that the distal end of the piercing needle is The straight tip of taper.

3. bilateral artificial cords implant system according to claim 1, which is characterized in that the diameter model of the push conduit It encloses for 10mm to 12mm.

4. bilateral artificial cords implant system according to claim 1, which is characterized in that the bilateral artificial cords implantation System further includes at least a pair of of artificial cords, and the every artificial cords, which include one section, has chordae tendineae main body flexible, described Chordae tendineae main body has opposite first end and second end, and the first end and/or the second end are connected with fixing piece, described solid Determine part for the piercing needle it is non-dismountable be fixedly connected or be detachably fixed connect.

5. bilateral artificial cords implant system according to claim 4, which is characterized in that the chordae tendineae main body is placed in institute It states in clamping push rod and the distal end collet, the fixing piece is placed in the distal end collet, and each fixing piece Proximal end respectively corresponds the piercing needle.

6. bilateral artificial cords implant system according to claim 5, which is characterized in that along axial direction in the clamping push rod Equipped with artificial cords channel, artificial cords accommodating chamber is equipped in the distal end collet, the artificial cords accommodating chamber is penetrated through to institute The proximal end face of distal end collet is stated, the artificial cords channel is connected with the artificial cords accommodating chamber, and the chordae tendineae main body is received It is dissolved in the artificial cords channel and the artificial cords accommodating chamber.

7. bilateral artificial cords implant system according to claim 6, which is characterized in that the proximal end face of the distal end collet Equipped with the lock chamber for accommodating the fixing piece, axially it is connected between the lock chamber and the artificial cords accommodating chamber.

8. bilateral artificial cords implant system according to claim 7, which is characterized in that the shape of the lock chamber and institute The shape for stating fixing piece matches, and the inscribe diameter of a circle of the lock chamber is greater than the circumscribed circle of the artificial cords accommodating chamber Diameter.

9. bilateral artificial cords implant system according to claim 4, which is characterized in that be also arranged in the chordae tendineae main body There is Non-slip material, the Non-slip material is equipped with the binding face being bonded with leaflet, and the Non-slip material slides axially along the chordae tendineae main body.

10. bilateral artificial cords implant system according to claim 9, which is characterized in that be equipped in the distal end collet Artificial cords accommodating chamber, the clamping face of the distal end collet are equipped with the lock chamber for accommodating the fixing piece and are used for collecting post State the container of Non-slip material, radial communication between the container and the artificial cords accommodating chamber, the container with it is described Radial communication between lock chamber.

11. bilateral artificial cords implant system according to claim 1, which is characterized in that the bilateral artificial cords are planted Entering system further includes clamping auxiliary device；The clamping auxiliary device includes actively being threaded onto the push conduit at least Two clamping sub-arms and the clamping auxiliary member for being respectively arranged on the clamping sub-arm distal end；At least two clampings sub-arm It is symmetrical set about the clamping push rod；The clamping auxiliary member is made of elasticity and/or flexible material；The clamping auxiliary Arm pushes the coupled clamping auxiliary member to be pierced by from the push distal end of catheter or clamping device distal end, the folder Hold auxiliary member and clamping device cooperation clamping leaflet.

12. bilateral artificial cords implant system according to claim 11, which is characterized in that along axis in the push conduit To equipped with sub-arm accommodating chamber, the axial folder between the axial direction of the push conduit of the distal portion of the sub-arm accommodating chamber Angular region is 120-150 °.

13. bilateral artificial cords implant system according to claim 11, which is characterized in that the clamping auxiliary member is not by Transmission X-ray material is made.