CN208989259U

CN208989259U - Artificial cords implant system

Info

Publication number: CN208989259U
Application number: CN201721035051.3U
Authority: CN
Inventors: 张庭超; 张伟伟; 周春远
Original assignee: Hangzhou De Jin Medical Technology Co Ltd
Current assignee: Hangzhou De Jin Medical Technology Co Ltd
Priority date: 2017-08-17
Filing date: 2017-08-17
Publication date: 2019-06-18
Anticipated expiration: 2027-08-17

Abstract

The utility model discloses a kind of artificial cords implant system, including clamping device, sting device and driving means.Driving means includes push conduit, and sting device and clamping device are actively installed on respectively in push conduit.Artificial cords are equipped in clamping device.Clamping auxiliary device includes the clamping sub-arm being actively threaded onto push conduit and the clamping auxiliary member set on clamping sub-arm distal end.Clamping auxiliary member is made of elasticity and/or flexible material, and clamping auxiliary member and clamping sub-arm are contained in jointly in push conduit.Clamping sub-arm pushes clamping auxiliary member to be pierced by from push distal end of catheter or clamping device distal end, clamping auxiliary member and clamping device cooperation clamping leaflet.In the artificial cords implant system of the utility model, clamping auxiliary member may be supported on the lower surface of leaflet, and clamping device is assisted to stablize the leaflet of beating, improves clamping stability, prevents leaflet from slipping from clamping device.

Description

Artificial cords implant system

Technical field

The utility model belongs to the field of medical instrument technology, is related to a kind of instrument for repairing heart valve defect, especially relates to And 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.

Chordae tendineae is unable to self-healing after there is lesion or rupture of chordae tendinca, even if a small number of ruptures of chordae tendinca, can also make other Chordae tendineae tension increases and new rupture of chordae tendinca occurs.Chordae tendineae of mitral valve fracture typical performance is that acute severe breathes, has difficulty in breathing Equal left heart failures, pulmonary edema performance, are partially in gradual chronic heart failure.Surgical operation implantable artificial tendon is generallyd use at present The mode of rope treats chordae tendineae lesion, needs using invasive Thoracotomy, and carry out general anesthesia, Moderate hypothermia cardiopulmonary bypass as auxiliary Help support.That there are surgical procedures is complicated for this kind of surgical operation, operation is at high cost, patient trauma degree is high, complication risk is high, lives The defects of institute's time is long and patient's recovery process is painful.

A kind of existing instrument by invasive manner implantable artificial chordae tendineae, the instrument clamp leaflet by capture component, During capturing leaflet, since leaflet is in pulsatile status always, and the surface of leaflet is smooth tissue, even if clamping dress Captured leaflet is set, leaflet may also fall off from clamping device, and operating time is caused to extend even operative failure.Also, After leaflet is captured, if it find that clip position is unreasonable, patient needs to finely tune clamping device, and leaflet is easily from clamping at this time It is slipped in device, operating time is caused to extend even operative failure.

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 clamping The artificial cords implant system stablized, prevent leaflet from slipping from clamping device.

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

Artificial cords implant system, including clamping device, sting device and driving means, the driving means include push Conduit, the sting device and the clamping device are actively installed on respectively in the push conduit.It is accommodated in clamping device There are artificial cords.The implant system further includes at least one clamping auxiliary device.The clamping auxiliary device includes actively The clamping sub-arm being threaded onto the push conduit and the clamping auxiliary member set on the clamping sub-arm distal end.The clamping Auxiliary member is made of elasticity and/or flexible material, and the clamping auxiliary member is contained in described push away with the clamping sub-arm jointly It send in conduit.The clamping sub-arm pushes the clamping auxiliary member from the push distal end of catheter or clamping device distal end It is pierced by, the clamping auxiliary member and clamping device cooperation clamping leaflet.As a result, clamping auxiliary member from push distal end of catheter or The lower surface of leaflet is stretched out and be supported in clamping device distal end, and clamping device can be assisted to stablize the leaflet of beating.

In the artificial cords implant system, the preferably described clamping auxiliary member axial direction and the clamping sub-arm axial direction Between angular range be 120-150 °.

In the artificial cords implant system, the preferably described clamping auxiliary member and the clamping sub-arm are integrated knot It is non-dismountable or be detachably fixed connection between structure or the clamping auxiliary member and the clamping sub-arm.

In the artificial cords implant system, the preferably described clamping sub-arm is the rod-shaped or tubular structure of hard；

Or the clamping sub-arm including elasticity or/and auxiliary arm body flexible and is set to the auxiliary arm body Rigid support body externally and/or internally.

In the artificial cords implant system, edge is axially arranged with sub-arm accommodating chamber, institute in the preferably described push conduit Stating sub-arm accommodating chamber includes distal end cavity and proximal end cavity, and the proximal end cavity is roughly parallel to the axis of the push conduit To the angular range between the distal end cavity and the proximal end cavity is 120-150 °.

In the artificial cords implant system, it is equipped with and holds between the preferably described clamping auxiliary member and the clamping sub-arm Supporting piece, the supporting parts are contained in the distal end cavity of the sub-arm accommodating chamber, and the hardness of the supporting parts is greater than institute It states the hardness of clamping auxiliary member and is less than the hardness of the clamping sub-arm.

In the artificial cords implant system, edge is axially arranged with sub-arm accommodating chamber, institute in the preferably described push conduit Stating sub-arm accommodating chamber is generally flat cavity, and the sub-arm accommodating chamber is obliquely installed in the push conduit, described The axial angular range between the axial direction of the push conduit of sub-arm accommodating chamber distal end is 120-150 °.

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

In the artificial cords implant system, the preferably described clamping auxiliary member is the bar formed by least one support rod Shape structure, the rod-like structure and the clamping sub-arm are contained in jointly in the push conduit；

Or the clamping auxiliary member is the distressed structure formed by more support rods, the distressed structure is selected from bifurcated knot At least one of structure, umbrella-shaped structure, closed loop configuration, laminated structure, reticular structure or disk-like structure, the distressed structure are shunk It is contained in the push conduit jointly after deformation with the clamping sub-arm；

Or the clamping auxiliary member is the sacculus with sacculus binding face, the sacculus binding face shape is matched with leaflet It closes, the sacculus is contained in the push conduit before expansion with the clamping sub-arm jointly.

In the artificial cords implant system, the preferably described artificial cords, which include one section, has chordae tendineae main body flexible, The 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, institute State fixing piece backwards to the side of chordae tendineae main body be equipped with for piercing needle it is non-dismountable be fixedly connected or be detachably fixed connect Piecing attachment.

In the artificial cords implant system, it is arranged with Non-slip material in the preferably described chordae tendineae main body, the Non-slip material is set There is the binding face being bonded with leaflet, the Non-slip material slides axially along the chordae tendineae main body；

One through-hole is set on the Non-slip material, and the chordae tendineae main body passes through the through-hole；

Or at least two through-holes are set on the Non-slip material, the first end and second end of the chordae tendineae main body is each passed through The different through-holes or at least two chordae tendineae main bodys respectively pass through the different through-holes.

In the artificial cords implant system, the preferably described clamping device includes clamping push rod and clamps for cooperating The distal end of the push conduit is arranged in the distal end collet and proximal end collet of leaflet, the proximal end collet, and the distal end collet is set It sets in the distal end of the clamping push rod；

On the clamping face of the proximal end collet, the side wall of the push conduit or the side wall of the proximal end collet be provided with Opening, the opening connect with the sub-arm accommodating chamber, and the clamping auxiliary member is pierced by from the opening.

In the artificial cords implant system, on the clamping face of the preferably described proximal end collet, it is described push conduit side At least two opening of the side wall of wall or proximal end collet setting, multiple openings are uniformly arranged in the circumferential direction, and each institute It states opening to connect with the sub-arm accommodating chamber, the clamping auxiliary member is pierced by from opening described at least one.

In the artificial cords implant system, the preferably described clamping auxiliary member includes two support rods and is connected to two Connecting rod between support rod, every support rod both correspond to the opening, and the length of the support rod is equal to or omits Greater than the length of the opening.

In the artificial cords implant system, edge is axially arranged with artificial cords channel, institute in the preferably described clamping push rod It states and is equipped with artificial cords accommodating chamber in the collet of distal end, the distal end of the artificial cords accommodating chamber is penetrated through to the distal end collet, institute Artificial cords channel is stated to be connected with the artificial cords accommodating chamber, the artificial cords be contained in the artificial cords channel and In the artificial cords accommodating chamber.

In the artificial cords implant system, the clamping face of the preferably described distal end collet is offered for accommodating artificial tendon The container of the Non-slip material of rope, radial communication between the container and the artificial cords accommodating chamber.

In the artificial cords implant system, the clamping face of the preferably described distal end collet is offered for accommodating artificial tendon The lock chamber of the fixing piece of rope is axially connected between the lock chamber and the artificial cords accommodating chamber, the lock chamber and institute State radial communication between container.

In the artificial cords implant system, the shape of the preferably described lock chamber and the shape of the fixing piece match It closes, 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 artificial cords implant system, the clamping of the clamping face and the distal end collet of the preferably described proximal end collet Face is bonded to each other, at least one described clamping face is equipped with the clamping reinforcement for enhancing chucking power.

The artificial cords implant system of the utility model compared with prior art, at least has the advantages that

Clamping auxiliary device is equipped in the artificial cords implant system of the utility model, wherein the clamping of clamping auxiliary device Sub-arm is actively installed in push conduit, and clamping auxiliary member is stretched out from push distal end of catheter or clamping device distal end, in valve After leaf is lived by distal end collet and proximal end grips, the distal portion for clamping auxiliary device may be supported on the lower surface of leaflet, by valve Leaf is held up to atrial side, and then reduces leaflet movable amplitude, and clamping device is assisted to stablize the leaflet of beating.Also, clamping auxiliary After device is supported on the lower surface of leaflet, if patient has found that clip position is undesirable, clamping device can be finely tuned, in fine tuning In the process, the supporting role for clamping auxiliary device can prevent leaflet from slipping from clamping device.

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 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 artificial cords in the artificial cords implant system of the utility model embodiment one；

Fig. 4 is the structural schematic diagram of second of embodiment of the artificial cords of the utility model embodiment one；

Fig. 5 is the structural schematic diagram of the third embodiment of the artificial cords of the utility model embodiment one；

Fig. 6 is the structural schematic diagram of the 4th kind of embodiment of the artificial cords of the utility model embodiment one；

Fig. 7 to Figure 10 is the fixing piece of the utility model embodiment one and the different embodiments structure that piercing needle is connect Schematic diagram；

Figure 11 is the structural schematic diagram of the artificial cords implant system of the utility model embodiment one；

Figure 12 is the explosive view of the artificial cords implant system of the utility model embodiment one；

Figure 13 is the structural representation in the artificial cords implant system of the utility model embodiment one, when clamping device separates Figure；

Figure 14 is in the artificial cords implant system of the utility model embodiment one, and the structure of the clamping face of distal end collet is shown It is intended to；

Figure 15 is the B-B cross-sectional view in Figure 14；

Figure 16-17 is in the artificial cords implant system of the utility model embodiment one, and the structure for clamping auxiliary device is shown It is intended to；

Figure 18 is to push distal end of catheter axial direction cross-sectional view in the artificial cords implant system of the utility model embodiment one；

Figure 19 is the partial enlarged view in Figure 18 at M；

Figure 20 is the structural schematic diagram of the artificial cords implant system distal end of the utility model embodiment one；

Figure 21 is to push second of embodiment party of distal end of catheter in the artificial cords implant system of the utility model embodiment one The axial sectional view of formula；

Figure 22 is the radial cross-section of the push conduit of the utility model embodiment one；

Figure 23 is the structural schematic diagram of the clamping auxiliary device distal end of the utility model embodiment one；

Figure 24 is the structural schematic diagram of the clamping auxiliary device another embodiment of the utility model embodiment one；

Figure 25 to Figure 31 is the mistake using the artificial cords implant system implantable artificial chordae tendineae of the utility model embodiment one Journey schematic diagram；

Figure 32 and Figure 33 is to clamp the difference of auxiliary device in the artificial cords implant system of the utility model embodiment two Embodiment structure schematic diagram；

Figure 34-36 is to clamp the different real of auxiliary device in the artificial cords implant system of the utility model embodiment three Apply mode structural schematic diagram；

Figure 37 is the structural schematic diagram of the clamping auxiliary device another embodiment of the utility model embodiment three；

Schematic diagram when Figure 38 a and Figure 38 b are the clamping auxiliary device and its support leaflet of the utility model embodiment three；

Figure 39 is the structural schematic diagram of the artificial cords implant system of the utility model embodiment five.

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.

In interventional medical device technical field, the bearing definition that generally will be close to operator is proximal end, far from operator Bearing definition is distal end.

Embodiment one

As shown in Fig. 3-31, artificial cords implant system substitutes patient for being implanted into the patient artificial cords 100 Lesion or the chordae tendineae of fracture in heart.Artificial cords implant system includes clamping device 300, sting device 400 and push dress 200 are set, driving means 200 includes push conduit 210, and sting device 400 and clamping device 300 are actively installed on push away respectively It send in conduit 210.Artificial cords 100 are equipped in clamping device 300.Artificial cords implant system further includes at least one clamping Auxiliary device 500.Clamping auxiliary device 500 includes the clamping sub-arm 520 being actively threaded onto push conduit 210 and is set to Clamp the clamping auxiliary member 510 of 520 distal end of sub-arm.Auxiliary member 510 is clamped to be used to cooperate clamping leaflet with clamping device 300, Clamping sub-arm 520 is used to support and pushes clamping auxiliary member 510.Auxiliary member 510 is clamped by elasticity and/or flexible material system At clamping auxiliary member 510 and clamping sub-arm 520 are contained in jointly in push conduit 210.It clamps sub-arm 520 and pushes clamping Auxiliary member 510 is pierced by from 210 distal end of push conduit or 300 distal end of clamping device, and clamping auxiliary member 510 is matched with clamping device 300 Co-clip holds leaflet.

As seen in figures 3-6, artificial cords 100, which include one section, has chordae tendineae main body 110 flexible.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 is backwards to chordae tendineae main body 110 side be equipped with for the non-dismountable piecing attachment 125 for being fixedly connected with or being detachably fixed connection of piercing needle.Tendon One end of rope main body 110 is fixed in leaflet, and the other end can be fixed in ventricle wall or the positions such as papillary muscle, to substitute disease The chordae tendineae of change maintains the tension between leaflet and ventricle wall.There is chordae tendineae main body 110 flexibility to refer to that it can be in axial tensionless winkler foundation Any bending, general chordae tendineae main body 110 use the form of flexible wires.The material of chordae tendineae main body 110 can be compatible with human body High molecular material or more soft metal material etc..Preferably high molecular material.

There is no the differences such as direction, significance level for the first end and second end of chordae tendineae main body 110.It is fixed as shown in Fig. 3 Part 120 can be set in one end of chordae tendineae main body 110, can also all be arranged at the both ends of chordae tendineae main body 110 as shown in Figure 4.People The quantity of work chordae tendineae 100 can be one, be also possible to as shown in Fig. 5 two or more.It is preferably artificial in the present embodiment The quantity of chordae tendineae 100 is one, and the first end and second end of chordae tendineae main body 110 is arranged in fixing piece 120.Chordae tendineae main body 110 It is fixedly connected between fixing piece 120, the mode being fixedly connected can be various using knotting, winding, welding, bonding, clamping etc. Fixed form, the utility model are not construed as limiting.For example, knotting after one end of chordae tendineae main body 110 can be pierced by fixing piece 120 The ball of string being relatively large in diameter is formed, end is perhaps welded as ball that one is relatively large in diameter or one is arranged again in end A locating rod.When the first end of chordae tendineae main body 110 is arranged in fixing piece 120, since the second end of chordae tendineae main body 110 is not set Set fixing piece 120, therefore second end is as shown in fig. 6, 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.

The effect of fixing piece 120 be for piercing needle formation be detachably fixed or it is non-removable be fixedly connected, Shape cooperates different connection types.Fixing piece 120 is equipped with piecing attachment 125 for the connection with piercing needle, due to wearing The distal end of pricker head is usually sharp taper, stable connection is such as formed, between fixing piece 120 and piercing needle outer surface There should be contact area as big as possible.Therefore the side backwards to chordae tendineae main body 110 of fixing piece 120 is equipped with and wears for accommodating The accommodating cavity 121 of pricker head, piecing attachment 125 are arranged in accommodating cavity 121.The shape of accommodating cavity 121 and piercing needle Distal end shape matches.Accommodating cavity 121 is generally in the shape of taper or cylindricality.The external global shape of general fixing piece 120 For cylindricality, cross-sectional shape can be the various shapes such as circle, ellipse, polygon, it is generally preferable to round and ellipse.It punctures Syringe needle 410 is equipped with the chordae tendineae connector 411 to form a fixed connection with the piecing attachment 125 of artificial cords 100.Chordae tendineae connects The major function of fitting 411 is to improve the reliability connected between piercing needle 410 and artificial cords 100.

There are many modes that the piecing attachment 125 of fixing piece 120 is connect with the chordae tendineae connector 411 of piercing needle 410, As shown in fig. 7, the first embodiment are as follows: piecing attachment 125 is the internal screw thread opened up on 121 side wall of accommodating cavity.Chordae tendineae connects Fitting 411 is the external screw thread being arranged on 410 outer surface of piercing needle；After the completion of puncture, piercing needle 410 and artificial cords 100 fixing piece 120 is spirally connected, and formation is detachably fixed connection.

As shown in figure 8, second of embodiment is: piecing attachment 125 is the bonding that is arranged on the side wall of accommodating cavity 121 Layer.Chordae tendineae connector 411 is the adhesive layer of 410 outer surface of piercing needle setting.Specifically, in 410 outer surface of piercing needle and 121 inner wall of accommodating cavity applies adhesive in whole or in part, forms adhesive layer, after the completion of puncture, as shown in figure 19, and as wearing The adhesive layer pierced on the fixing piece 120 of connector 125 is adhesively fixed, and forms non-removable entirety.

As shown in figure 9, the third embodiment are as follows: piecing attachment 125 is coarse to be arranged on the side wall of accommodating cavity 121 Face.Chordae tendineae connector 411 is the rough surface of 410 outer surface of piercing needle setting.After the completion of puncture, fixing piece 120 and puncture Syringe needle is by frictional resistance, and after the completion of puncture, formation is detachably fixed connection.

As shown in Figure 10, the 4th kind of embodiment are as follows: piecing attachment 125 is that the side wall of accommodating cavity 121 opens up at least One groove or hole.Chordae tendineae connector 411 be arranged in piercing needle 410 distal portion and with 120 piecing attachment of fixing piece 125 form interference fit, at least one double wedge for snapping connection or being keyed or at least one circle convex edge.Hole or groove can be with It is that blind hole is also possible to through-hole, as long as its shape is substantially worked in coordination with the protrusion or convex edge being arranged on piercing needle, to be formed It snaps connection.In the present embodiment, three grooves 125 are preferably provided with, to improve the company between fixing piece 120 and piercing needle Stability is connect, the amplitude that piercing needle can shake after connecting is reduced.

Key connection can choose the key connections modes such as flat key connection, spline connection, and form tight key connection, so that axis Pulling force can be also transmitted upwards, and key connection structure is routine techniques, and details are not described herein.

As shown in Figures 4 to 6, in order to be increased to face contact for the point contact between artificial cords 100 and leaflet, thus It is effectively reduced the risk that artificial cords 100 tear leaflet, is preferably arranged with Non-slip material 130 in chordae tendineae main body 110, and anti-skidding Part 130 can slide axially along chordae tendineae main body 110.It is anti-skidding when piercing needle punctures leaflet and fixed artificial cords 100 as a result, Part 130 is set in advance in artificial cords 100, Non-slip material 130 can be pushed to point of puncture, by Non-slip material 130 and artificial cords 100 are fixed in leaflet together.Specific set-up mode of the Non-slip material 130 in artificial cords 100 is: setting on Non-slip material 130 Through-hole 131 is set, chordae tendineae main body 110 is pierced by from through-hole 131.The setting quantity of through-hole 131 and the fixed form of Non-slip material 130 have It closes.A kind of mode is that a Non-slip material 130 is corresponded on every chordae tendineae, and a through-hole is arranged in this structure on Non-slip material 130 131, chordae tendineae main body 110 passes through the through-hole 131 (as shown in Figures 5 and 6).Another way is arranged at least on Non-slip material 130 Two through-holes 131, the first end and second end of a chordae tendineae main body 110 are each passed through different through-holes 131 (as shown in Figure 4). It can also be and at least two through-holes 131 are set on Non-slip material 130, at least two chordae tendineae main bodys 110 respectively pass through different through-holes 131, i.e. a Non-slip material 130 is arranged in two artificial cords 100.

Non-slip material 130 falls off from artificial cords 100 in order to prevent, and the diameter of the through-hole 131 on Non-slip material 130 is less than The diameter of fixing piece 120.And the free end for being not provided with fixing piece 120 of chordae tendineae main body 110 should be by knotting or setting The modes such as bulbous end, plate-like end are set, so that the diameter of the free end is greater than the diameter of the through-hole 131 on Non-slip material 130 (such as Shown in Fig. 6).

As shown in Figures 4 to 6, in order to active force of the chordae tendineae main body 110 to leaflet is dispersed to Non-slip material 130 and valve as far as possible Contact surface between leaf, the needs of Non-slip material 130 are bonded as far as possible with leaflet, therefore Non-slip material 130 is equipped with the fitting being bonded with leaflet Face 132.Other than binding face 132,130 specific structure of Non-slip material is not construed as limiting, and can have a variety of structures: for example can be has Sheet, the plate-like or spherical, even irregular shape, preferably sheet of certain area.The structure of Non-slip material 130 can be nothing Pore structure is also possible to reticular structure, grating structure etc..Non-slip material 130 should be made of biocompatible materials, can in characteristic To be made of elastic material, it is also possible to non-elastic material and is made.Specifically, Non-slip material 130 is selected from elastomeric pad, heart is mended At least one of piece, felt piece, network, disk-like structure or double disk-like structures.Wherein there is disk-like structure or double The structure of the Non-slip material 130 of disk-like structure is similar to plugging device in the prior art, and details are not described herein.Preferably, in order to subtract The overall dimensions of small instrument, the Non-slip material 130 with disk-like structure or double disk-like structures should be made of shape-memory material.

As shown in Figure 11 to Figure 13, artificial cords implant system includes clamping device 300, sting device 400 and push dress Set 200.The main structure of driving means 200 is push conduit 210.Push conduit 210 is the tubulose with certain axial length Body or rhabodoid with inner cavity.Pushing conduit 210 has multiple mutually separated axial bores.Pushing conduit 210 can be with Using integrally formed multi-lumen tube, outer tube and inner tube suit can also be fixed together, form integrally-built push conduit 210.Pushing conduit 210 can be using the high molecular material of biocompatibility (for example, polyformaldehyde POM, polythene PE, nylon PA, polyvinylchloride, acrylonitrile-butadiene-styrene copolymer ABS, nylon elastomer Pebax or polyurethane PU) or Person's metal material (for example, stainless steel or Nitinol) is 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 an inner cavity of conduit 210 and is coated with sting device 400.Sting device 400 include piercing needle 410 and The puncture push rod 420 being connect with 410 proximal end of piercing needle.The effect of piercing needle 410 is to puncture leaflet and and artificial cords 100 fixing piece 120 connects, and chordae tendineae main body 110 is pulled to proximal end.It is formed in leaflet for the ease of puncturing and reducing The straight tip that puncture spot diameter, the preferably distal end of piercing needle 410 are taper.The hook-shaped needle of straight tip compared to the prior art Head, the point of puncture formed in leaflet is small, postoperative easy healing.What the artificial cords implant system of the present embodiment was formed in leaflet The diameter range of point of puncture is usually 0.3mm to 1.5mm, further, by the shape of suitable piercing needle 410 and straight The diameter range of diameter, point of puncture can be controlled in 0.7mm or so.

410 proximal end of piercing needle, which is connected with, punctures push rod 420, punctures 420 proximal end of push rod and is equipped with third handle 401, punctures Push rod 420 is actively installed in the inner cavity of push conduit 210.It is worn from push 210 proximal end of conduit the proximal end of third handle 401 Out, as a result, by the axial movement of operation third handle 401, it can drive and puncture push rod 420 along the axial direction of push conduit 210 It is mobile, and then piercing needle 410 is driven to puncture to distal end or proximally withdraw.After leaflet is clamped, piercing needle 410 exists Third handle 401 drive under, pierce through leaflet, after connect with the fixing piece 120 of artificial cords 100, piercing needle 410 with manually Chordae tendineae 100 is connected to become an entirety by fixing piece 120.

Clamping device 300 includes clamping push rod 330, distal end collet 310 and proximal end collet 320.Clamping push rod 330 is threaded onto In an inner cavity for pushing conduit 210.The distal end of push conduit 210 is arranged in proximal end collet 320.The setting of distal end collet 310 exists Clamp the distal end of push rod 330.The proximal end for clamping proximal end from the push conduit 210 of push rod 330 is pierced by and second handle 301 is arranged. Second handle 301 is pushed to distal end as a result, drives clamping push rod 330 mobile to distal end, so that distal end collet 310 is far from proximal end Collet 320 forms open configuration as shown in fig. 13 that, at this time fine-tuning instrument distal end, so that leaflet enters distal end collet 310 Behind the space formed between proximal end collet 320, second handle 301 is proximally withdrawn, clamping push rod 330 is driven proximally to move It is dynamic, so that proximally collet 320 is close for distal end collet 310, form clamp position as shown in figure 11.At this point, leaflet is clamped Device 300 is clamped and is fixed.The shape of proximal end collet 320 and distal end collet 310 should match unification with the shape of push conduit 210 It causes, forms the entirety of a smooth in appearance, convenient for push, and mitigate the damage to patient wound.It is understood that this place That states pushes second handle 301 to make distal end collet 310 far from the state of proximal end collet 320 to distal end, can also be by close End withdraws first handle 201 and push conduit 210 to reach.

In the prior art, the artificial cords being implanted into such a way that U-shaped ring set combines hook-shaped syringe needle will cause leaflet valve edge Fold makes the position of leaflet form artificial notch, can not form pairing edge, be easy to cause mitral reflux, surgical effect is not It is ideal.Artificial cords implant system provided in this embodiment, every artificial cords and the spacing at leaflet edge are almost the same, can have Effect avoids leaflet edge fold, improves surgical effect.

As shown in figs. 11 and 15, in order to improve the stability of clamping, the clamping face of proximal end collet 320 and distal end collet 310 Clamping face should be bonded to each other, and be respectively provided with biggish leaflet contact area.Preferably, two clamping faces are all obliquely installed, That is clamping face and push conduit 210 is axial at less than 90 ° angles.In addition, at least one clamping face is equipped with for enhancing clamping The clamping reinforcement of power.It is preferred that clamping reinforcement is the protrusion being arranged on clamping face, fin, groove, at least one in pit Kind.Setting fin, which is used as, in the present embodiment, on the clamping face 311 of distal end collet 310 clamps reinforcement 312, between each fin In parallel, step-like clamping face 311 is formed.

As shown in figs. 14-15, it is set in distal end collet 310 in clamping push rod 330 along artificial cords channel 331 is axially arranged with There is artificial cords accommodating chamber 315.Artificial cords accommodating chamber 315 is connected with artificial cords channel 331.The tendon of artificial cords 100 Rope main body 110 is contained in artificial cords channel 331 and artificial cords accommodating chamber 315.

The clamping face 311 of distal end collet 310 offers the container 314 for accommodating Non-slip material 130.Container 314 with Radial communication between artificial cords accommodating chamber 315.

The clamping face 311 of distal end collet 310 is also provided with the lock chamber of the fixing piece 120 for accommodating artificial cords 100 313.It is axially connected between lock chamber 313 and artificial cords accommodating chamber 315.Radially connect between lock chamber 313 and container 314 It is logical.The fixing piece 120 of artificial cords 100 is accommodated in distal end collet 310 as a result, and 120 proximal end of fixing piece and piercing needle 410 is corresponding.After piercing needle 410 is connect with fixing piece 120, push rod can be punctured by proximally dropping back, drive puncture needle First 410, fixing piece 120, chordae tendineae main body 110 and Non-slip material 130 are drawn out by the clamping face of distal end collet 310 simultaneously, until wearing Pricker head 410, fixing piece 120 and chordae tendineae main body 110 pass through leaflet jointly, and Non-slip material 130 conforms to the upper surface of leaflet.

It is axially connected between lock chamber 313 and artificial cords accommodating chamber 315.The effect of lock chamber 313 is both can will be artificial The fixing piece 120 of chordae tendineae 100 is fixed in lock chamber 313, again can be from lock chamber after fixing piece 120 is by external force drawing It is successfully pulled out in 313.Therefore, the shape of lock chamber 313 is matched with the shape of fixing piece 120, and the inscribe of lock chamber 313 Diameter of a circle is greater than the external diameter of a circle of artificial cords accommodating chamber 315.Preferably, the circumscribed circle of artificial cords accommodating chamber 315 Diameter and lock chamber 313 inscribed circle diameter ratio be (0.2~0.4): 1.When lock chamber 313 and artificial cords accommodating chamber When 315 cross section is circle, the inscribe diameter of a circle of lock chamber 313 is the straight of the circular cross section of lock chamber 313 Diameter, the external diameter of a circle of artificial cords accommodating chamber 315 are the diameter of the circular cross section of artificial cords accommodating chamber 315.This In embodiment, the cross section of lock chamber 313 is circle, and a diameter of D1, the cross section of artificial cords accommodating chamber 315 is circle, A diameter of D2, and D2 is the 30% of D1.The purpose of such setting is: if D2 is excessive, piercing needle 410 is puncturing push rod 420 Promotion under when cooperating with the fixing pieces 120 of artificial cords 100, due to puncturing the thrust to distal end of push rod 420, fixing piece 120 may slip out of lock chamber 313 into artificial cords accommodating chamber 315, lead to piercing needle 410 and artificial cords 100 It cannot be disposably successfully connected between fixing piece 120, extend operating time；If D2 is too small, the chordae tendineae main body of artificial cords 100 110 cannot pass through from artificial cords accommodating chamber 315, lead to the fixing piece 120 of piercing needle 410 Yu artificial cords 100 After connection, artificial cords 100 cannot smoothly be pulled out to the clamping face 311 of clamping push rod 330.

It is fixed in order to which chordae tendineae main body 110 and Non-slip material 130 successfully to be pulled out to the clamping face 311 of distal end collet 310 Radial communication between chamber 313 and container 314.Preferably, the width of the connected component between lock chamber 313 and container 314 D3 is the 20%-50% of D1, and the purpose of such setting is: if D3 is excessive, the fixing piece 120 of artificial cords 100 cannot jail Admittedly be fixed in the lock chamber 313 of distal end collet 310, it is easy to slipped out of lock chamber 313, directly result in device failure； It, cannot be swimmingly by fixing piece after piercing needle 410 is connect with the fixing piece 120 of artificial cords 100 if D3 is too small 120 pull out out of lock chamber 313, lead to operative failure.It is understood that in other embodiments, lock chamber 313 and artificial The cross section of chordae tendineae accommodating chamber 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 Wherein it is smooth by.

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, the frictionally damage to tissue is increased, while the problem of leaking blood occurs, increases the wind that patient generates postoperative complications Danger.And the lock chamber 313 of the utility model setting, it is easy for for artificial cords 100 being placed and secured in inside instrument.It avoids The problems of the prior art.Most important to also reside in: the presence of lock chamber 313 may be implemented do not having to unclamp 310 He of distal end collet Chordae tendineae main body 110 and Non-slip material 130 are pulled to leaflet under the premise of proximal end collet 320, therefore pressed from both sides in distal end collet 310 and proximal end When being converted to open configuration by closed state between first 320, leaflet is detached from from clamping device 300, the moment of preparatory stroke, Chordae tendineae main body 110 will not individually be contacted with leaflet, and the linear incision effect of chordae tendineae main body 110 is avoided to generate wound to the leaflet of beating Evil.

As shown in figure 16, it in order to further strengthen clamping, is also provided in the artificial cords implant system of the utility model Auxiliary device 500 is clamped, clamping auxiliary device 500 includes clamping auxiliary member 510 and clamping sub-arm 520.In order to facilitate push, In clamping also settable 4th handle 501 in 520 proximal end of sub-arm.

As shown in Figure 12 and Figure 18-19, along sub-arm accommodating chamber 250 is axially arranged in push conduit 210, that is, pushing Selected in multiple inner cavities of conduit 210 one as sub-arm accommodating chamber 250.Before puncture, clamping auxiliary member 510 and clamping are auxiliary Arm 520 is helped all to be housed in sub-arm accommodating chamber 250.As shown in Figure 18-20, on the clamping face of proximal end collet 320, pushes and lead The side wall of pipe 210 or the side wall of proximal end collet 320 are provided with opening 260, and opening 260 connects with sub-arm accommodating chamber 250, When operator to distal end push the 4th handle 501, can drive clamping sub-arm 520 push clamping auxiliary member 510 from opening 260 in It is pierced by.

Figure 22 is referred to, clamping push rod 330 and puncture push rod 420 are threaded onto jointly in push conduit 210, and clamp push rod 330 is axial parallel with push conduit 210 with the axial direction for puncturing push rod 420.Clamping push rod 330 is set to push conduit 210 Side, puncture push rod 420 be set to push conduit 210 the other side and with clamping push rod 330 be oppositely arranged.Suffer to mitigate Person's damage, reduces the cardiac incision of patient, should minimize the entire outer diameter of push conduit 210, therefore preferably sub-arm is received Cavity 250 is arranged between the accommodating chamber 280 of clamping push rod 330 and the accommodating chamber 270 of puncture push rod 420.

As shown in Figure 11-12, Figure 20, when 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 leaflet and valve at this time in order to allow the leaflet of beating to keep stablizing convenient for puncturing as far as possible The opposite other side of limb edge provides support force, it is therefore desirable to make to clamp auxiliary member 510 and push between conduit 210 to have centainly Angle can be supported on the lower surface of the side leaflet opposite with leaflet edge.Therefore, it is necessary to make sub-arm accommodating chamber 250 The angle that range is 120-150 ° is formed between the axial direction of distal portion and the axial direction for pushing conduit 210.Sub-arm accommodating chamber 250 , can be with push 210 axis parallel of conduit along the axial setting of push conduit 210, can also be not parallel, specifically assisted with clamping The structure of device 500 matches.

If Figure 18 and Figure 19 show a kind of embodiment of sub-arm accommodating chamber 250, sub-arm accommodating chamber 250 is along push The axial setting of conduit 210, sub-arm accommodating chamber 250 are generally flat cavity, entire sub-arm accommodating chamber 250 be obliquely installed in It pushes in conduit 210, and the angle α range between the axial direction of 250 distal end of sub-arm accommodating chamber and the axial direction for pushing conduit 210 is 120-150°.Or be as shown in figure 21 250 another embodiment of sub-arm accommodating chamber, sub-arm accommodating chamber 250 includes remote Hold cavity 251 and proximal end cavity 252, proximal end cavity 252 is roughly parallel to the axial direction of push conduit 210, distal end cavity 251 with The range of angle γ between proximal end cavity 252 is 120-150 °.As long as guaranteeing between distal end cavity 251 and proximal end cavity 252 Smooth transition does not influence to clamp the passing through in sub-arm accommodating chamber 250 of sub-arm 520.

The shape of sub-arm accommodating chamber 250 and clamping 520 shape of sub-arm cooperation, cross section can be round or oval Any suitable shapes such as shape, crescent, partially circular, polygonal, preferably circle or ellipse without corner angle.

Figure 23 is referred to, clamping auxiliary device 500 includes clamping sub-arm 520 and set on clamping 520 distal end of sub-arm Clamp auxiliary member 510.Clamping the axial angular range between clamping 520 axial direction of sub-arm of auxiliary member 510 is 120-150 °.Folder It holds auxiliary member 510 and clamps leaflet for auxiliary holding device 300.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 damage leaflet can be effectively avoided.Such as it can choose gold Belong to material, polymer material or Metal polymer composite to be made.Elastic material is preferably shape-memory material.

As shown in figs. 16-17, auxiliary member 510 is clamped in the present embodiment is the rod-shaped knot formed by least one support rod Structure.Rod-like structure and clamping sub-arm 520 are contained in jointly in push conduit 210.Wherein, the clamping auxiliary member 510 in Figure 16 For the rod-like structure that a support rod is formed, it is rod-shaped that the clamping auxiliary member 510 in Figure 17 is that two support rods arranged side by side are formed Structure.Support rod can also be by individual thread or more for the solid or hollow structure of single layer perhaps multi-layer compound structure Filament winding system forms.The section of support rod can be regular circle or the shapes such as ellipse, crescent, partially circular, polygonal, It is preferably circular.Clamping auxiliary member 510 is preferably made of the elastic material with memory function, and clamping auxiliary member 510 is smooth , such as smooth round end is formed by laser spot welding, the defects of without burr, seamed edge, corner angle.

For the ease of being supported on the lower surface of leaflet, 510 diameter of clamping auxiliary member of rod-like structure is preferably greater than rod-shaped Clamping sub-arm 520, to form relatively stable support to leaflet.

As shown in figs. 16-17, clamping sub-arm 520 is the support rod with axial length, can be by single layer or multilayer Hollow or solid construction the metallic rod or high molecular material bar of composite construction are made, can also by individual thread or multi-filament around It makes.Wherein, the clamping sub-arm 520 in Figure 16 is a support rod, and the clamping sub-arm 520 in Figure 17 is two arranged side by side Support rod.Clamp sub-arm 520 section can for regular circle or ellipse, crescent, it is partially circular, polygonal or The shapes such as person's annular, it is preferably circular.Clamping sub-arm 520 is preferably made of the material with memory function, can be by metal Material, polymer material or Metal polymer composite are made.Clamping sub-arm 520, which is preferentially selected as, to be had centainly firmly Degree or rigidity are to provide a supporting and can pushability.Sub-arm 520 is clamped in advance mounted in the sub-arm accommodating chamber of push conduit 210 In 250.As shown in figure 20, after the opening of auxiliary member 510 from sub-arm accommodating chamber 250 to be held is pushed out, auxiliary member 510 is clamped It is attached to the lower surface of leaflet, there is elasticity or clamping auxiliary member 510 flexible can comply with the movable amplitude of leaflet well, no It can cause perforation of valve cusp because of too hard or stab.Clamping 520 hardness of sub-arm is higher, more conducively pushes the transmitting of power, thus Can be driven by mobile 4th handle 501 entire clamping sub-arm 520 relative to push conduit 210 to distal end it is mobile or to Proximal end is withdrawn.

As shown in figs. 16-17, clamping auxiliary member 510 and clamping sub-arm 520 can be integral structure, or clamping auxiliary It is non-dismountable or be detachably fixed and link together between part 510 and clamping sub-arm 520.The integral structure system of being integrally formed , specifically, integral structure can be by with certain axial length, single layer or multi-layer compound structure, hollow or solid Metallic rod or high molecular material bar be made, can also be formed by individual thread or multi-filament coiling.Non-dismountable fixation is: folder One is fixedly connected on by forms such as welding, bondings again after holding sub-arm 520 and the first individually processing of clamping auxiliary member 510 It rises.Being detachably fixed is: after clamping sub-arm 520 and the first individually processing of clamping auxiliary member 510, being connected by socket, screw thread It the forms such as connects, be interference fitted to be fixed together.Above-mentioned connection type is routine techniques, and details are not described herein.

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 the rod-shaped or tubulose of hard Structure；Clamping auxiliary member 510 is made of elasticity and/or flexible material.

It is understood that in other embodiments, clamping sub-arm 520 also may include elasticity or sub-arm flexible Main body 521 and the rigid support body 522 (as shown in figure 24) inside or outside auxiliary arm body 521.The supporter of hard 522 are used to support auxiliary arm body 521.Supporter 522 can be set with or be set side by side with auxiliary arm body 521.First use The whole body of rod or tube body is made as the clamping auxiliary member 510 and sub-arm master clamped in auxiliary device 500 in relatively soft material Then body 521 is assisting the inner cavity of arm body 521 to wear the higher inner tube of hardness or outside the part of auxiliary arm body 521 Surface is arranged or is set side by side the higher outer tube of hardness as supporter 522 to improve the branch for clamping 520 close end of sub-arm Support property；Relatively soft 521 outer surface of auxiliary arm body can also be wrapped in as supporter 522 using heat-shrink tube, then heated The outer surface of auxiliary arm body 521 is wrapped in after shrinking heat-shrink tube to improve supportive.It will also be appreciated that for single The thermoplastic elastomer (TPE)s such as Pebax first can also be wrapped in sub-arm by auxiliary arm body 521 made of silk or multi-filament coiling The partial outer face of main body 521, then heating is wrapped in outer surface after melting thermoplastic elastomer (TPE) while infiltrating into multi-filament Or in the gap between individual thread (that is, supporter 522 is set to auxiliary arm body 521 outwardly and inwardly), to improve auxiliary The supportive of arm body 521.

In order to adapt to the shape of sub-arm accommodating chamber 250, clamping auxiliary member 510 is axial and clamps 520 axial direction of sub-arm Between angle β range be 120-150 °.As shown in figure 16, the clamping auxiliary member 510 of single rod and clamping sub-arm 520 it Between angle be 120 °.As shown in figure 17, the clamping auxiliary member 510 of plurality of rods shape and the angle clamped between sub-arm 520 are equal It is 140 °.It is understood that in other embodiments, if integrally formed clamping sub-arm is made using flexible material 520 and clamping auxiliary member 510, then in its natural state, clamping auxiliary member 510 is axial can between clamping 520 axial direction of sub-arm Not have angle, only when the two is accommodated to sub-arm accommodating chamber 250, due to the distal end cavity of sub-arm accommodating chamber 250 Angle between 251 and proximal end cavity 252, so that clamping auxiliary member 510 is axial to form model between clamping 520 axial direction of sub-arm Enclose the angle for 120-150 °.

As shown in figure 23, it is to be understood that in order to improve clamping auxiliary member 510 to the supportive of leaflet, preferably clamp The supporting parts 530 for being used to support clamping auxiliary member 510 and support leaflet are equipped between auxiliary member 510 and clamping sub-arm 520.It holds Supporting piece 530 is contained in the distal end cavity 251 of sub-arm accommodating chamber 250.The hardness of supporting parts 530 is greater than clamping auxiliary member 510 Hardness and be less than clamping sub-arm 520 hardness.As a result, when clamping auxiliary member 510 is stretched out from opening 260 and is contacted with leaflet Afterwards, which is located at the lower surface of leaflet and holds up leaflet, due to clamping the elasticity of auxiliary member 510, supporting parts 530 Also with leaflet beating and move up and down, and since the hardness of supporting parts 530 is higher, more effectively branch can be provided leaflet Support.In this embodiment, since the higher supporting parts 530 of hardness may can not be successfully through sub-arm accommodating chamber 250, because This preferred sub-arm accommodating chamber 250 is the straight cavity being obliquely installed in push conduit 210；Or as shown in figure 21, preferably Sub-arm accommodating chamber 250 includes distal end cavity 251 and proximal end cavity 252, and proximal end cavity 252 is roughly parallel to push conduit 210 Axial direction, between distal end cavity 251 and proximal end cavity 252 formed angle γ range be 120-150 °, supporting parts 530 accommodate In distal end cavity 251.In this embodiment, it in order to which supporting parts 530 are placed in push conduit 210, needs to use The push conduit 210 of split-type design, that is, push conduit 210 includes two pipes with substantially semi-circular section relative to each other Clamping sub-arm 520, supporting parts 530 and clamping auxiliary member 510 when production and assembly, are first placed on one of pipe by body jointly In the sub-arm accommodating chamber 250 of body, then the other half tube body and the tube body are butted against and fixed together.

Clamping auxiliary member 510 is made by not transmiting X-ray material.In the prior art, gripping means grips leaflet it Before, the lower mode of rank cannot be required to judge the relative position between instrument and leaflet by operations such as X-rays, need to rely on Accurately clamping device could be moved to suitable position by ultrasonic guidance, and pass through the pulsatile status of ultrasound observation leaflet, to Leaflet drives rapidly the relative motion between distal end collet and proximal end collet to clamp leaflet when beating to close to clamping device.It is super Sound has higher requirement to the operating technology of doctor and the analysis ability of cardiac ultrasound images, and operating difficulty is caused to increase, hand The art time increases, so that increasing patient the risk of complication occurs.The clamping auxiliary member 510 of the present embodiment is contacted with leaflet Afterwards, flexible or elasticity clamping auxiliary member 510 can be generated with the movable amplitude of leaflet and be swung accordingly, therefore clamped Before device clamps leaflet, operator can rapidly and accurately judge the position of leaflet by X-ray, thus more rapidly accurate Ground operates clamping device to clamp leaflet, shortens operating time, improves success rate of operation.

By taking the chordae tendineae implantation of mitral valve clamping as an example, illustrate artificial cords implant system provided in this embodiment Implementation process:

Step 1: referring to Figure 25, artificial cords implant system is advanced into left ventricle, continues that artificial cords is promoted to plant Enter system until distal end collet 310 and proximal end collet 320 are respectively positioned in atrium sinistrum；

Step 2: refer to Figure 26, proximally withdraw push conduit 220 or push clamping push rod 330 to distal end, so that Proximal end collet 320 positioned at push 220 distal end of conduit is separated with the distal end collet 310 for being located at clamping 330 distal end of push rod, at this time closely It holds and forms leaflet accommodation space between collet 320 and distal end collet 310；

Step 3: referring to fig. 27, the 4th handle 501 is pushed to distal end, the 4th handle 501 driving clamping sub-arm 520 pushes away It send clamping auxiliary member 510 to be pierced by from opening 260, clamps auxiliary member 510 at this time and be supported on leaflet lower surface to assist stabilization to fight Dynamic leaflet keeps the relative position between first handle 201, second handle 301 and the 4th handle 501 constant, proximally delays Slowly entire instrument is moved, until leaflet enters in the leaflet accommodation space formed between proximal end collet 320 and distal end collet 310, And clamping auxiliary member 510 can provide leaflet certain support force；

Step 4: 8a and Figure 28 b referring to fig. 2, the distal end of slight mobile artificial cords implant system, until leaflet edge with It clamps push rod 330 to contact, second handle 301 of proximally dropping back at this time, proximally collet 320 is mobile straight for driving distal end collet 310 It is closed to the two, leaflet is clamped；

Step 5: pushing third handle 401 to distal end, driving piercing needle 410 is along the axial to distal end of push conduit 210 It is mobile, that is, piercing needle 410 is mobile to 310 direction of distal end collet, until piercing needle 410 passes through leaflet, and and artificial cords It forms a fixed connection between 100 fixing piece 120；

Step 6: referring to fig. 29, third handle 401 of dropping back, so that piercing needle 410 drives the fixation of artificial cords 100 Part 120, the chordae tendineae main body 110 being connected with fixing piece 120 sequentially pass through leaflet, and Non-slip material 130 is also by the folder from distal end collet 310 The pull-out of face 311 is held, the binding face (that is, lower surface) of Non-slip material 130 is contacted with the upper surface of leaflet, while partial chordae tendineae main body 110 upper surfaces for pushing down Non-slip material 130 make it be bonded leaflet (as shown in figure 30), at this point, between artificial cords 100 and leaflet Point contact is converted into the face contact between Non-slip material 130 and leaflet, can effectively reduce the risk of leaflet tearing；

Step 7: continue drop back third handle 401 until fixing piece 120 from push conduit 210 proximal end withdraw from, then after The 4th handle 501 is removed, clamping auxiliary member 510 is driven to withdraw into sub-arm accommodating chamber 250, withdraws from entire artificial cords implantation 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 separately fixed at ventricle wall Upper (as shown in figure 31).

In aforementioned 4th step, after leaflet is clamped the clamping of device 300, if it find that clip position is undesirable, Ke Yiwei It adjusts the relative position of distal end collet 310 and proximal end collet 320 to generate certain distance therebetween, then clamps valve again Leaf；It, can be with since the clamping auxiliary device 500 below leaflet has certain supporting role to leaflet during fine tuning Prevent leaflet from slipping from clamping device 300.

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

After leaflet is lived by distal end collet and proximal end grips, the clamping auxiliary member positioned at the distal end of clamping sub-arm can be propped up Support assists clamping device to stablize the leaflet of beating in the lower surface of leaflet.After device to be held clamps leaflet, if necessary to micro- Adjust clip position, clamping auxiliary device below leaflet has supporting role to leaflet, can be effectively prevented leaflet from It is slipped in clamping device.

Embodiment two

The structure of the artificial cords implant system of the artificial cords implant system and embodiment one of the present embodiment is essentially identical, The difference is that: clamping auxiliary member 510 is the distressed structure formed by more support rods.After distressed structure contraction distortion with folder Sub-arm 520 is held to be contained in jointly in push conduit 210.Specifically, distressed structure is open to be formed by more support rods Bifurcation structure or umbrella-shaped structure.For the ease of push conduit in be pushed, clamping auxiliary member 510 have compressive state and Extended state when nature.Auxiliary member 510 is clamped in compressive state, it can be in the sub-arm accommodating chamber of push conduit 210 It is pushed in 250；When clamping auxiliary member 510 is by being set to the clamping face of proximal end collet 320, pushing the side wall of conduit 210 or close It holds after being stretched out in the opening 260 of the side wall of collet 320, is changed into extended state, may be supported on the lower surface of leaflet, stablize valve Leaf is conducive to puncture.

As shown in figure 32, clamping auxiliary member 510 is by two support bar groups at the distal end of every support rod is smooth knot Structure, such as the structure type of round end, the defects of without burr, seamed edge, corner angle.Clamping auxiliary member 510 has branch type structure, point The angle of forkRange is 20 ° -150 °, is preferably 60 ° -90 °, clamps auxiliary member to provide stable supportive and not influence 510 are proximally recycled in push conduit 210.The support rod for forming bifurcation structure has flexible and elasticity, and two support rods can With receiving after closing up into the inner cavity of push conduit 210, after being released from push conduit 210, two support rods are due to it Itself flexible and/or elasticity can be restored to the bifurcation structure with certain angle to support leaflet.

On the clamping face of proximal end collet 320, push conduit 210 side wall or proximal end collet 320 side wall setting at least Two openings 260, multiple openings 260 are uniformly arranged in the circumferential direction, and each opening 260 connects with sub-arm accommodating chamber 250, Clamping auxiliary member 510 is pierced by from least one opening 260.

In use, the bifurcation structure for clamping auxiliary member 510 is first retracted to proximal end collet 320 or push conduit 210 in advance In, in the sub-arm accommodating chamber 250 of clamping sub-arm 520 receiving to push conduit 210, proximal end is close from push conduit 210 End is pierced by.When four handle 501 for pushing clamping 520 proximal end of sub-arm to distal end axial along instrument, clamping auxiliary member 510 Bifurcation structure can be released swimmingly from opening 260, and since its own flexibility and/or elasticity can turn after release Become extended state (that is, restore bifurcation structure) under natural conditions, to valve after the following table face contact of the bifurcation structure and leaflet Leaf provides support force；When proximally pulling clamping sub-arm 520 axial along instrument, two support rods of bifurcation structure close up, whole A bifurcation structure is swimmingly retracted in the sub-arm accommodating chamber 250 of push conduit 210.Clamp sub-arm 520 and clamping auxiliary Part 510 can be integrally formed overall structure, clamping sub-arm 520 and clamping auxiliary member 510 can also with after separately formed again It fits together.

It is understood that in other embodiments, a sub-arm accommodating chamber can be only arranged by pushing in conduit 210 250, at least two clamping auxiliary devices 500 are threaded onto the sub-arm accommodating chamber 250 simultaneously, that is, multiple independent clampings are arranged Auxiliary member 510 and coupled clamping sub-arm 520 (as shown in figure 33).Multiple clamping auxiliary members 510 are opened via same Mouth 260 is pierced by, and has certain angle between more at this time clamping auxiliary members 510, and form branch type structure or umbrella shape knot Structure, the branch type structure or beveled structure are supported on the lower surface of leaflet, provide more effective support.In this embodiment In, it can be fixed together by locating parts such as hoop, outer tubes between more clamping sub-arms 520, may not necessarily also be passed through Locating part is fixed to one another, and the radial deflection between multiple clamping sub-arms 520 is only limited by the wall surface of sub-arm accommodating chamber 250. In addition, operator can individually control the axial movement of each clamping sub-arm 520, with adjust each clamping auxiliary member 510 and Relative position between leaflet, and then leaflet structure of different shapes is adapted to, reach more preferably support effect.It is also understood that It is that in other embodiments, multiple clamping auxiliary members 510 can also be pierced by via different openings 260 respectively, at this time multiple folders Holding also has certain angle between auxiliary member 510, to form branch type structure or beveled structure.

It is understood 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 33. 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.

The clamping auxiliary member being relatively large in diameter is arranged in the distal end of auxiliary device, and the contact surface for clamping auxiliary member and leaflet is to press from both sides The plane where auxiliary member is held, therefore, the contact area between auxiliary device and leaflet is bigger, and support force is stronger；And it can be with Preferably fitting leaflet improves auxiliary device to the supportive of leaflet.

Embodiment three

The structure of the artificial cords implant system of the artificial cords implant system and embodiment one of the present embodiment is essentially identical, The difference is that the clamping auxiliary member 510 positioned at clamping 520 distal end of sub-arm is the deformation knot formed by more support rods Structure is contained in push conduit 210 after distressed structure contraction distortion with clamping sub-arm 520 jointly.Deformation in the present embodiment Structure is closed loop configuration, and closed loop configuration can be circle, diamond shape, ellipse, pyriform, polygon or other are irregular but can be with The shape for forming enclosed construction, as shown in Figure 34-36.

The proximal end of two support rods is preferably arranged in a crossed manner, that is, and the proximal end of clamping auxiliary member 510 is numb flower type structure, by This, can increase clamping auxiliary member 510 and clamp the stress point area between sub-arm 520, the beating of leaflet is avoided to cause to clamp Junction deforms between auxiliary member 510 and clamping sub-arm 520, further increases clamping auxiliary member 510 to the supportive of leaflet.

It is understood that at least one tool can also be arranged in other embodiments, between the support rod of closed loop configuration Flexible and/or elastic connecting rod 511 further enhances clamping auxiliary member 510 to improve the self stability of closed loop configuration To the support force of leaflet.As shown in figure 37, clamping auxiliary member 510 includes two support rods and is connected between two support rods Connecting rod 511, every support rod both correspond to an opening 260, and the length of support rod is equal to or slightly greater than the length of opening 260 Degree.

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 netted knot It is configured to the disk-like structure (being similar to single-deck plugging device in the prior art) of stretchable deformation, disk-like structure can be further warm Setting treatment forms the structures such as column, nido, oblate shape.As long as clamping auxiliary member 510 is made of shape-memory material, Ji Ketong The sub-arm accommodating chamber 250 crossed in push conduit 210 conveys, and is stretched out by opening 260, restores to natural unfolded state, with Leaflet following table face contact simultaneously provides support to leaflet.

Due to sub-arm accommodating chamber 250 opening 260 and push conduit 210 axial direction between angle α range be 120 °- 150 °, therefore be pushed out when being located at the clamping auxiliary member 510 for clamping 520 distal end of sub-arm via opening 260, clamp auxiliary member 510 restore to extended state, and clamp auxiliary member 510 and push the angle for forming that range is 120 ° -150 ° between conduit 210 (as shown in Figure 38 a).The following table face contact (as shown in Figure 38 b) of auxiliary member 510 and leaflet 600 is clamped as a result, and contacts mask There is biggish area, therefore the auxiliary device of the present embodiment can provide more stable support force.

Example IV

The artificial cords implant system of the present embodiment and the artificial cords implant system of embodiment one the difference is that: folder Holding auxiliary member 510 is the sacculus with sacculus binding face, and institute's sacculus binding face shape and leaflet cooperate, sacculus before expansion with folder Sub-arm 520 is held to be contained in jointly in push conduit 210.

Specifically, clamping sub-arm 520 is hollow conduit, and clamping auxiliary member 510 is oblate distensible sacculus, Distensible sacculus (that is, clamping auxiliary member 510) proximal end is connect, balloon lumen with hollow conduit (that is, clamping sub-arm 520) It is communicated with conduit cavity.The flat part of sacculus forms sacculus binding face, is used for and leaflet following table face contact.Conduit is actively worn In sub-arm accommodating chamber 250 loaded on push conduit 210, push conduit 210 is contained in after unexpanded sacculus flap winding In sub-arm accommodating chamber 250, the proximal end of conduit connects female Luer, and can be connected with balloon dilatation pressure pump, passes through mobile Shandong That connector drives conduit mobile, can be by sacculus from the clamping face of proximal end collet 320, the side wall of push conduit 210 or close It holds the opening 260 of the side wall of collet 320 to release, contrast agent is then passed through into balloon lumen to fill by balloon dilatation pressure pump Be full of sacculus, the flat sacculus binding face of sacculus can provide support force with the following table face contact of leaflet at this time, and it is full after Sacculus has good development effect, and operator can observe the movable amplitude of sacculus by X-ray, to judge the position of leaflet It sets.After puncture, to sacculus pressure release, sacculus and conduit can be withdrawn from entire artificial cords via sub-arm accommodating chamber 250 Implant system.Sacculus operating method is all current routine techniques in distensible balloon structure and art, herein no longer in more detail Narration.

After the completely full expansion of sacculus as clamping auxiliary member, flat a sacculus binding face and leaflet can be formed Contact improves the support force to leaflet, and complies with the movable amplitude of leaflet.Meanwhile the contrast agent being perfused in sacculus to operate Person can observe balloon position by X-ray, and after sacculus is contacted with leaflet, sacculus generates corresponding with the movable amplitude of leaflet It swings, to indicate the position of leaflet, operator is assisted to clamp leaflet.

Embodiment five

Refer to Figure 39, the area of the artificial cords implant system of the artificial cords implant system and embodiment three of the present embodiment Place is not: clamping sub-arm 520 is actively installed in sub-arm accommodating chamber 250, the distal end setting of clamping sub-arm 520 Clamp auxiliary member 510.Clamping auxiliary member 510 includes two support rods and the connecting rod being connected between two support rods.Proximal end On the clamping face of collet 320, side wall at least two through-holes of setting of conduit 210 or proximal end collet 320 are pushed as opening 260, multiple openings 260 are uniformly arranged in the circumferential direction, and each opening 260 connects with sub-arm accommodating chamber 250.For example, can Two openings 260 are set simultaneously in the side wall of push conduit 210, or the setting two simultaneously on the clamping face of proximal end collet 320 Two openings 260 are arranged in a opening 260, the side wall living in proximal end collet 320 simultaneously.Every of composition clamping auxiliary member 510 Support rod both corresponds to an opening 260, and the length of support rod is equal to or slightly greater than the length of opening 260.That is, support rod is remote End is pierced by and is connected with each other by connecting rod via in one of opening 260 respectively.

Two support rods and connecting rod first pass through in advance thermal finalization processing, formed circle, diamond shape, pyriform, polygon or other The closed loop configuration being substantially closed.

Before use, clamping sub-arm 520 is installed in sub-arm accommodating chamber 250, support rod is installed on auxiliary at opening 260 It helps in arm accommodating chamber 250, connecting rod is attached to the outer surface of push conduit 210 or proximal end collet 320.It is understood that In other embodiments, the outer surface of proximal end collet 320 may be provided for the groove of receiving connecting rod.

In use, the 4th handle 501 by pushing clamping 520 proximal end of sub-arm, so that clamping sub-arm 520 is along axis To distal end movement, keep support rod gradually fully extended from the opening 260 of push conduit 210 or proximal end collet 320, until Nature after support rod and connecting rod recovery heat setting treatment, that is, when entire clamping auxiliary member 510 recovery extended state Closed loop states.At this point, support rod and connecting rod form a plane, which holds up leaflet with after leaflet following table face contact, Support force is provided.

It is understood that in this embodiment, if a clamping sub-arm 520 is used only, should press from both sides Hold and one section of changeover portion be respectively set between the distal end of sub-arm 520 and the proximal end of two support rods, the length of changeover portion be greater than or Person is equal to the length of support rod, and as a result, after the 4th handle 501 for pushing clamping 520 proximal end of sub-arm, changeover portion enters opening It is ejected completely in 260 and by support rod, support rod and connecting rod restore the nature after thermal finalization.

It will also be appreciated that in other embodiments, two clamping sub-arms 520 also can be used, every clamping is auxiliary It helps the distal end of arm 520 that a piece support rod is set, is connected between two support rods by connecting rod, pushing two clampings as a result, After 4th handle 501 of 520 proximal end of sub-arm, two clamping sub-arms 520 respectively eject two support rods completely, support Bar and connecting rod restore the nature after thermal finalization.It is understood that in other embodiments, if clamping sub-arm 520 itself hardness it is lower, then changeover portion need not be set, only rely on clamping sub-arm 520 by support rod release opening 260.

The contact area clamped between auxiliary member and leaflet is bigger, also, when active force of the clamping auxiliary member by leaflet, Single stress point between support rod and clamping sub-arm is changed into the stress surface between two support rods and two openings, effect After power is dispersed, bigger support force can be provided, can preferably comply with the movable amplitude of leaflet, holds up leaflet.

To sum up, the artificial cords implant system of the utility model, by increasing clamping in artificial cords implant system Auxiliary device clamps auxiliary member from push wherein the clamping sub-arm of clamping auxiliary device is actively installed in push conduit Distal end of catheter or clamping device distal end are stretched out, and after leaflet is lived by distal end collet and proximal end grips, clamping auxiliary member can be propped up Support is held up in the lower surface of leaflet, by leaflet to atrial side, and then reduces leaflet movable amplitude, and clamping device is assisted to stablize beating Leaflet.It, can if operator has found that clip position is undesirable also, after clamping auxiliary device is supported on the lower surface of leaflet To finely tune clamping device, during fine tuning, the supporting role for clamping auxiliary device can prevent leaflet sliding from clamping device It is de-.

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

1. artificial cords implant system, including clamping device, sting device and driving means, the driving means includes that push is led Pipe, the sting device and the clamping device are actively installed in the push conduit respectively, hold in the clamping device It is equipped with artificial cords, it is characterised in that: the implant system further includes at least one clamping auxiliary device；

The clamping auxiliary device includes the clamping sub-arm being actively threaded onto the push conduit and is set to the clamping The clamping auxiliary member of sub-arm distal end；

The clamping auxiliary member is made of elasticity and/or flexible material, and the clamping auxiliary member and the clamping sub-arm are common It is contained in the push conduit；

The clamping sub-arm pushes the clamping auxiliary member to be pierced by from the push distal end of catheter or clamping device distal end, The clamping auxiliary member and clamping device cooperation clamping leaflet.

2. artificial cords implant system according to claim 1, which is characterized in that the clamping auxiliary member it is axial with it is described Clamping the angular range between sub-arm axial direction is 120-150 °.

3. artificial cords implant system according to claim 1, which is characterized in that the clamping auxiliary member and the clamping Sub-arm be structure as a whole or the clamping auxiliary member and the clamping sub-arm between the non-dismountable or company of being detachably fixed It connects.

4. artificial cords implant system according to claim 1, which is characterized in that the clamping sub-arm is the bar of hard Shape or tubular structure；

Or the clamping sub-arm including elasticity or/and auxiliary arm body flexible and is set to the sub-arm body exterior And/or internal rigid support body.

5. artificial cords implant system according to claim 1, which is characterized in that edge is axially arranged in the push conduit Sub-arm accommodating chamber, the sub-arm accommodating chamber include distal end cavity and proximal end cavity, and the proximal end cavity is roughly parallel to institute The axial direction for stating push conduit, the angular range between the distal end cavity and the proximal end cavity are 120-150 °.

6. artificial cords implant system according to claim 5, which is characterized in that the clamping auxiliary member and the clamping Supporting parts are equipped between sub-arm, the supporting parts are contained in the distal end cavity of the sub-arm accommodating chamber, described to hold The hardness of supporting piece is greater than the hardness of the clamping auxiliary member and is less than the hardness of the clamping sub-arm.

7. artificial cords implant system according to claim 1, which is characterized in that edge is axially arranged in the push conduit Sub-arm accommodating chamber, the sub-arm accommodating chamber are generally flat cavity, and the sub-arm accommodating chamber is obliquely installed in described It pushes in conduit, the axial angular range between the axial direction of the push conduit of sub-arm accommodating chamber distal end is 120- 150°。

8. artificial cords implant system according to claim 1, which is characterized in that the clamping auxiliary member is not Transmission X Ray material is made.

9. artificial cords implant system according to claim 1, which is characterized in that the clamping auxiliary member is by least one The rod-like structure that root support rod is formed, the rod-like structure and the clamping sub-arm are contained in jointly in the push conduit；

Or the clamping auxiliary member is the distressed structure formed by more support rods, the distressed structure be selected from bifurcation structure, At least one of umbrella-shaped structure, closed loop configuration, laminated structure, reticular structure or disk-like structure, the distressed structure, which is shunk, to be become It is contained in the push conduit jointly after shape with the clamping sub-arm；

Or the clamping auxiliary member is the sacculus with sacculus binding face, the sacculus binding face shape and leaflet cooperate, institute Sacculus is stated to be contained in jointly in the push conduit before expansion with the clamping sub-arm.

10. artificial cords implant system according to claim 1, which is characterized in that the artificial cords include one section of tool Flexible chordae tendineae main body, the chordae tendineae main body have opposite first end and second end, the first end and/or described second End is connected with fixing piece, the fixing piece backwards to the side of chordae tendineae main body be equipped with for piercing needle is non-dismountable is fixedly connected Or it is detachably fixed the piecing attachment of connection.

11. artificial cords implant system according to claim 10, which is characterized in that be arranged in the chordae tendineae main body anti- Saddle, the Non-slip material are equipped with the binding face being bonded with leaflet, and the Non-slip material slides axially along the chordae tendineae main body；

Or at least two through-holes are set on the Non-slip material, the first end and second end of the chordae tendineae main body is each passed through difference The through-hole or at least two chordae tendineae main bodys respectively pass through the different through-holes.

12. artificial cords implant system according to claim 1, which is characterized in that the clamping device includes that clamping pushes away Bar and for cooperate clamping leaflet distal end collet and proximal end collet, the proximal end collet be arranged in it is described push conduit it is remote The distal end of the clamping push rod is arranged in end, the distal end collet；

On the clamping face of the proximal end collet, the side wall of the push conduit or the side wall of the proximal end collet be provided with out Mouthful, the opening connects with the sub-arm accommodating chamber, and the clamping auxiliary member is pierced by from the opening.

13. artificial cords implant system according to claim 12, which is characterized in that the clamping face of the proximal end collet The side wall of upper, described push conduit or at least two opening of side wall setting of the proximal end collet, multiple openings are along week To being uniformly arranged, and each opening connects with the sub-arm accommodating chamber, the clamping auxiliary member from least one It is pierced by the opening.

14. artificial cords implant system according to claim 12, which is characterized in that the clamping auxiliary member includes two Support rod and the connecting rod being connected between two support rods, every support rod both correspond to the opening, the support The length of bar is equal to or slightly greater than the length of the opening.

15. artificial cords implant system according to claim 12, which is characterized in that set in the clamping push rod along axial direction There is artificial cords channel, artificial cords accommodating chamber is equipped in the distal end collet, the distal end of the artificial cords accommodating chamber penetrates through To the distal end collet, the artificial cords channel is connected with the artificial cords accommodating chamber, and the artificial cords are contained in In the artificial cords channel and the artificial cords accommodating chamber.

16. artificial cords implant system according to claim 12, which is characterized in that the clamping face of the distal end collet is opened Container equipped with the Non-slip material for accommodating artificial cords radially connects between the container and the artificial cords accommodating chamber It is logical.

17. artificial cords implant system according to claim 16, which is characterized in that the clamping face of the distal end collet is opened Lock chamber equipped with the fixing piece for accommodating artificial cords axially connects between the lock chamber and the artificial cords accommodating chamber It is logical, radial communication between the lock chamber and the container.

18. artificial cords implant system according to claim 17, which is characterized in that the shape of the lock chamber with it is described The shape of 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.

19. artificial cords implant system according to claim 12, which is characterized in that the clamping face of the proximal end collet with The clamping face of the distal end collet is bonded to each other, at least one described clamping face, which is equipped with the clamping for enhancing chucking power, to be enhanced Part.