CN109893297A - Artificial cords implant system with clamping auxiliary device - Google Patents
Artificial cords implant system with clamping auxiliary device Download PDFInfo
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- CN109893297A CN109893297A CN201711288779.1A CN201711288779A CN109893297A CN 109893297 A CN109893297 A CN 109893297A CN 201711288779 A CN201711288779 A CN 201711288779A CN 109893297 A CN109893297 A CN 109893297A
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- artificial cords
- distal end
- arm
- leaflet
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Abstract
The artificial cords implant system of band clamping auxiliary device disclosed by the invention, including push conduit, clamping device, sting device and clamping auxiliary device, clamping device includes the clamping push rod for being equipped with artificial cords and distal end collet and proximal end collet for cooperating clamping leaflet, and sting device includes puncturing push rod and set on the piercing needle for puncturing push rod distal end.Clamping push rod and puncture push rod are actively installed on respectively in push conduit, piercing needle has tapered distal end and hook-shaped body, clamping auxiliary device includes actively being installed in push conduit to clamp sub-arm and the clamping auxiliary member set on clamping sub-arm distal end, and clamping sub-arm pushes clamping auxiliary member to cooperate clamping leaflet with clamping device after the stretching of the distal end of artificial cords implant system.In artificial cords implant system of the invention, 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
Technical field
The invention belongs to the field of medical instrument technology, it is related to a kind of instrument for repairing heart valve defect more particularly to people
Work chordae tendineae 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.The mode for generalling use surgical operation implantable artificial chordae tendineae at present treats chordae tendineae
Lesion is needed using invasive Thoracotomy, and carries out general anesthesia, Moderate hypothermia cardiopulmonary bypass as auxiliary support.This kind of surgery
Performing the operation, there are surgical procedure complexity, perform the operation high at high cost, patient trauma degree height, complication risk, hospital stays length and trouble
The defects of person's recovery process is painful.
A kind of existing instrument by invasive manner implantable artificial chordae tendineae, the instrument first pass through gripping apparatus grips and fixation
Leaflet, then artificial cords in conjunction with artificial cords and are pulled to ventricle wall and fixed by puncture needle.However since leaflet is in always
Pulsatile status, and the surface of leaflet is smooth tissue, causes clamping device to be difficult rapidly successfully to clamp leaflet, even if having pressed from both sides
Leaflet is held, leaflet may also fall off from clamping device, and operating time is caused to extend even operative failure.Also, in leaflet quilt
After capture, if it find that clip position is undesirable, patient needs to finely tune clamping device, and leaflet is sliding easily from clamping device at this time
It is de-, cause operating time to extend even operative failure.
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, it is auxiliary to provide a kind of band clamping
Help the artificial cords implant system of device, can fast clamp leaflet, and improve leaflet clamping stability, prevent leaflet from clamp
It is slipped in device.
The technical solution adopted by the present invention to solve the technical problems is:
Artificial cords implant system with clamping auxiliary device, including push conduit, clamping device, sting device and clamping
Auxiliary device.The clamping device includes the clamping push rod for being equipped with artificial cords and the distal end collet for cooperating clamping leaflet
With proximal end collet.The sting device includes that at least one punctures push rod and set on the piercing needle for puncturing push rod distal end.
The clamping push rod and the puncture push rod are actively installed on respectively in the push conduit.The piercing needle has taper
Distal end and hook-shaped body.The clamping auxiliary device includes the clamping sub-arm being actively installed in the push conduit and sets
Clamping auxiliary member in the clamping sub-arm distal end.The clamping sub-arm pushes the clamping auxiliary member to lead from the push
Pipe distal end or proximal end collet distal end are stretched out, the clamping auxiliary member and clamping device cooperation clamping leaflet.It presss from both sides as a result,
Holding auxiliary member may be supported on the lower surface of leaflet, assists clamping device to stablize the leaflet of beating, prevents leaflet from clamping device
It slips.
In the artificial cords implant system, the preferably described clamping auxiliary member is made of elasticity and/or flexible material.
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 being made of at 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 being made of more support rods, the distressed structure is selected from bifurcated knot
At least one of structure, umbrella-shaped structure, closing structure, 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.
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 and/or 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
The angular range stated between the distal portion of sub-arm accommodating chamber and the axial direction of the push conduit is 120-150 °.
In the artificial cords implant system, the distal end of the push conduit, institute is arranged in the preferably described proximal end collet
The distal end that the clamping push rod is arranged in distal end collet is stated, artificial cords accommodating chamber is equipped in the distal end collet, it is described artificial
Chordae tendineae accommodating chamber is connected with the inner cavity of the clamping push rod.
In the artificial cords implant system, edge is axially arranged with puncture channel in the preferably described distal end collet, described to wear
The distal end in transfixation road is penetrated through to the artificial cords accommodating chamber, the piercing needle hooked after being pierced by from the puncture channel take it is described
Artificial cords；Or the artificial cords accommodating chamber is penetrated through to the clamping face of the distal end collet, the piercing needle is described in
The clamping face of proximal end collet hooks after being pierced by and takes the artificial cords.
In the artificial cords implant system, the preferably described artificial cords are the closed loop configuration that both ends are connected.
In the artificial cords implant system, the preferably described artificial cords are equipped with Non-slip material, and the Non-slip material has
At least two through-holes are arranged on the Non-slip material in the binding face being bonded with leaflet, and the both ends of the artificial cords are each passed through not
It is connected after the same through-hole, the Non-slip material is contained in the clamping push rod or in the distal end collet.
Artificial cords implant system with clamping auxiliary device of the invention compared with prior art, at least has with following
Beneficial effect:
The setting clamping auxiliary device in artificial cords implant system, in leaflet by distal end collet and proximal end grips
Afterwards, clamping sub-arm pushes clamping auxiliary member to stretch out from push distal end of catheter or proximal end collet distal end, and clamping auxiliary member is supported on
Leaflet is held up to atrial side, and then reduces leaflet movable amplitude by the lower surface of leaflet, and clamping device is assisted to stablize the valve of beating
Leaf.Also, after clamping auxiliary device is supported on the lower surface of leaflet, if patient has found that clip position is undesirable, it can finely tune
Clamping device, during fine tuning, the supporting role for clamping auxiliary device can prevent leaflet from slipping from clamping device.
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 artificial cords in the artificial cords implant system of the embodiment of the present invention one；
Fig. 4 is the structural schematic diagram of the artificial cords implant system of the embodiment of the present invention one；
Fig. 5 is the explosive view of the artificial cords implant system of the embodiment of the present invention one；
Fig. 6 is the structural schematic diagram in the artificial cords implant system of the embodiment of the present invention one, when clamping device separates；
Fig. 7 a is the structural schematic diagram of sting device in the artificial cords implant system of the embodiment of the present invention one；
Fig. 7 b is the partial enlarged view of the piercing needle in Fig. 7 a；
Fig. 8 is the structural schematic diagram of distal end collet in the artificial cords implant system of the embodiment of the present invention one；
Fig. 9 is in the artificial cords implant system of the embodiment of the present invention one, and clamping auxiliary member is stretched out from push distal end of catheter
Structural schematic diagram；
Figure 10 is to push the radial cross-section of conduit in the artificial cords implant system of the embodiment of the present invention one；
Figure 11 is the schematic diagram that clamping auxiliary member in Fig. 9 is supported on leaflet lower surface；
Figure 12 is to push the axial sectional view of distal end of catheter in the artificial cords implant system of the embodiment of the present invention one；
Figure 13 is the axial sectional view for pushing the another embodiment of distal end of catheter；
Figure 14 is to clamp the structural schematic diagram of auxiliary device in the artificial cords implant system of the embodiment of the present invention one；
Figure 15 is the structural schematic diagram for clamping the another embodiment of auxiliary device；
Figure 16 is the structural schematic diagram for clamping the another embodiment of auxiliary device；
Figure 17 to Figure 24 is shown using the process of the artificial cords implant system implantable artificial chordae tendineae of the embodiment of the present invention one
It is intended to；
Figure 25 and Figure 26 is to clamp the different of auxiliary device in the artificial cords implant system of the embodiment of the present invention two and implement
Mode structural schematic diagram；
Figure 27 a-27c is to clamp the different of auxiliary device in the artificial cords implant system of the embodiment of the present invention three and implement
Mode structural schematic diagram；
Figure 28 a and Figure 28 b are the using process diagrams of the clamping auxiliary device of the embodiment of the present invention three, wherein Figure 28 a
It is the schematic diagram for clamping auxiliary device and being stretched out from push distal end of catheter, Figure 28 b is that clamping auxiliary device is supported on leaflet lower surface
When schematic diagram；
Figure 29 is the structural schematic diagram for clamping the another embodiment of auxiliary device.
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.
The bearing definition that will be close to operator below is proximal end, and the bearing definition far from operator is distal end.
Embodiment one
As shown in Fig. 3-24, the artificial cords implant system with clamping auxiliary device is suffered from for being implanted into artificial cords 100
In person's body, lesion or the chordae tendineae of fracture in patient's heart are substituted.Artificial cords implant system includes clamping device 300, punctures
Device 400, driving means 200 and clamping auxiliary device 500.Driving means 200 includes push conduit 210.Clamping device 300 wraps
Include the clamping push rod 330 for being equipped with artificial cords 100 and distal end collet 310 and proximal end collet 320 for cooperating clamping leaflet.
Sting device 400 includes puncturing push rod 420 and set on the piercing needle 410 for puncturing 420 distal end of push rod.It clamps push rod 330 and wears
Thorn push rod 420 is actively installed on respectively in push conduit 210.Piercing needle 410 has tapered distal end and hook-shaped body.Clamping
Auxiliary device 500 includes the clamping sub-arm 520 being actively installed in push conduit 210 and is set to clamping sub-arm 520 far
The clamping auxiliary member 510 at end.Clamping sub-arm 520 pushes clamping auxiliary member 510 from 210 distal end of push conduit or proximal end collet
320 distal ends are stretched out, clamping auxiliary member 510 and the cooperation clamping leaflet of clamping device 300.
As shown in figure 3, artificial cords 100 have certain length and flexibility.There is artificial cords 100 flexibility to refer to it in axis
To tensionless winkler foundation, can arbitrarily be bent.Artificial cords 100 are by having the high molecular material of biocompatibility or more soft gold
Belong to material to be made.The artificial cords 100 of the present embodiment be the flexible wires made of PTFE, and the both ends of flexible wires by knot,
The modes such as bonding, which are connected, constitutes closed loop configuration.As a result, after piercing needle 410 punctures leaflet and hook takes artificial cords 100, it can incite somebody to action
One end of ring structure pulls to proximal end, is fixed in papillary muscle or ventricle wall after leaflet, and the other end of ring structure stays in
Leaflet upper surface maintains the tension between leaflet and ventricle wall with this, and is implanted into two tendons between leaflet and ventricle wall simultaneously
Rope improves procedure efficiency and effect.
Artificial cords 100 are equipped with Non-slip material 130, and at least two through-holes 131, artificial cords 100 are arranged on Non-slip material 130
Both ends be each passed through to knot to be fixed together after different through-holes 131 and constitute closed loop configuration.Non-slip material 130 can be as a result,
It slides but not falls off in artificial cords 100.Non-slip material 130 is contained in clamping push rod 330, punctures valve in piercing needle 410
After leaf and hook take artificial cords 100, Non-slip material 130 is punctured device 400 with extremely via clamping push rod 330 and distal end collet 310
Point of puncture, Non-slip material 130 and artificial cords 100 are fixed in leaflet jointly, and the pad of Non-slip material 130 is in artificial cords 100 and valve
Between leaf upper surface, so that the point contact between artificial cords 100 and leaflet is increased to face contact, artificial cords 100 are reduced
Tear the risk of leaflet.
In order to which active force of the artificial cords 100 to leaflet is dispersed to the contact surface between Non-slip material 130 and leaflet as far as possible,
Non-slip material 130 needs to be bonded leaflet as far as possible, therefore Non-slip material 130 has 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, such as can be sheet with certain area, plate-like, spherical or other
Irregular shape, preferably sheet.Non-slip material 130 can be non-porous structure, reticular structure or grating structure etc..Non-slip material 130
It can be made of elastic material or non-elastic material, and should have biocompatibility.Specifically, Non-slip material 130 is selected from elastic cushion
At least one of piece, cardiac patch, felt piece, network, disk-like structure or double disk-like structures.With disk-like structure or
The structure of the Non-slip material 130 of the double disk-like structures of person is similar to plugging device in the prior art, and details are not described herein.Preferably, it is
The overall dimensions for reducing instrument, the Non-slip material 130 with disk-like structure or double disk-like structures should by shape-memory material system
At.The Non-slip material 130 of the present embodiment is elastomeric pad made of silica gel.
As shown in Figures 4 to 6, the main structure of driving means 200 is push conduit 210.Pushing conduit 210 is with one
Determine the tubular body of axial length or the rhabodoid with inner cavity.Pushing conduit 210 has multiple mutually separated axial bores.
Integrally formed multi-lumen tube can be used by pushing conduit 210, be also possible to more root canal bodies and be set with the entirety to be formed that is fixed together
Structure.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
Metal material (for example, stainless steel or Nitinol) is made.The proximal end for pushing conduit 210 is equipped with first handle 201, for grasping
Vertical push conduit 210 is withdrawn to distal end push or proximally.
As shown in Figure 7a, sting device 400 includes that at least one punctures push rod 420 and set on puncture 420 distal end of push rod
Piercing needle 410.The effect of piercing needle 410 is to puncture leaflet and hook to take artificial cords 100, then artificial cords 100 are drawn
Proximally.As shown in Figure 7b, piercing needle 410 has tapered distal end and hook-shaped body.Hook-shaped body takes artificial cords for hooking
100, the point of puncture that tapered distal end is formed in leaflet is smaller, is conducive to patient's postoperation recovery.In the present embodiment, push rod 420 is punctured
Quantity be one.In order to guarantee the connection validity between sting device 400 and artificial cords 100, the number of push rod 420 is punctured
Amount can be two or two or more.
The proximal end of push rod 420 is punctured from setting third handle 401 after 210 proximal end of conduit is pierced by is pushed, passes through operation 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.
Referring again to fig. 4 to fig. 6, clamping device 300 includes clamping push rod 330, distal end collet 310 and proximal end collet 320.
Clamping push rod 330 is actively installed in push conduit 210.The distal end of push conduit 210 is arranged in proximal end collet 320.Distally
The distal end of clamping push rod 330 is arranged in collet 310.The proximal end for clamping proximal end from the push conduit 210 of push rod 330 is pierced by and is arranged
Second handle 301.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, far from proximal end collet 320, form open configuration as shown in FIG. 6, at this time fine-tuning instrument distal end, so that leaflet enters far
It holds between collet 310 and proximal end collet 320, then proximally withdraws second handle 301, driving clamping push rod 330 moves to the near end,
So that proximally collet 320 is close for distal end collet 310, clamp position as shown in Figure 4 is formed, at this point, leaflet is clamped device
300 clamp and fix.The shape of proximal end collet 320 and distal end collet 310 should be consistent with the shape cooperation of push conduit 210, far
End collet 310 and proximal end collet 320 should form the entirety of smooth in appearance after closure, in order to push and mitigate to patient wound
Damage.
In order to improve the stability of clamping, the clamping face (that is, distal surface of proximal end collet 320) of proximal end collet 320 with
The clamping face (that is, proximal end face of distal end collet 310) of distal end collet 310 should be bonded to each other, and be respectively provided with biggish valve
Leaf contact area.Preferably, two clamping faces are all obliquely installed, i.e., clamping face and push conduit 210 are axial in less than 90 ° folders
Angle.In addition, the clamping face of distal end collet 310 and/or proximal end collet 320 is equipped with the clamping reinforcement for enhancing chucking power.
Clamping reinforcement is preferably at least one of protrusion, fin, groove or pit, and the clamping face of distal end collet 310 is arranged
The shape of clamping reinforcement that should be arranged with the clamping face of proximal end collet 320 of shape of clamping reinforcement work in coordination, make
It is very close to each other between distal end collet 310 after must being closed and proximal end collet 320.In the present embodiment, the clamping face of distal end collet 310
It is used as clamping reinforcement with a plurality of parallel fin is respectively set on the clamping face of proximal end collet 320, when distal end collet 310 and closely
It is very close to each other therebetween after holding collet 320 to be closed.
Clamping push rod 330 is tubular body or hollow rod shape body with certain axial length, and cross section is preferably ellipse
Or it is round.Edge is axially arranged with artificial cords channel 331 in clamping push rod 330.It is equipped in distal end collet 310 logical with artificial cords
The artificial cords accommodating chamber 315 that road 331 is connected, artificial cords accommodating chamber 315 is in U-shape or V-arrangement, both ends respectively with artificial tendon
Suo Tongdao 331 is connected, and artificial cords 100 are contained in artificial cords channel 331 and artificial cords accommodating chamber 315 (such as Fig. 8 institute
Show).Along puncture channel 334 is axially arranged in distal end collet 310, the distal end of puncture channel 334 is penetrated through to artificial cords accommodating chamber
315, piercing needle 410 can be distally advanced along puncture channel 334 as a result, take artificial cords 100 until hooking, then proximally
Recession punctures push rod 420, and piercing needle 410, artificial cords 100 and Non-slip material 130 can be driven simultaneously by distal end collet 310
Clamping face is drawn out, until piercing needle 410 and artificial cords 100 pass through leaflet jointly, and Non-slip material 130 conforms to leaflet
Upper surface.It is understood that artificial cords accommodating chamber 315 can also be penetrated through to the clamping face of distal end collet 310, distal end at this time
Puncture channel 334 need not be set in collet 310, and piercing needle 410, which can also hook, takes artificial cords 100.
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 artificial cords are placed and secured in inside instrument by the present embodiment, avoid foregoing problems.
In addition, 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
The fold of edge makes to form artificial notch between leaflet edge, can not pairing, lead to mitral reflux, surgical effect is undesirable.This
The artificial cords implant system that embodiment provides, every artificial cords and the spacing at leaflet edge are almost the same, can effectively avoid
Leaflet edge fold improves surgical effect.
It is also set up in artificial cords implant system of the invention referring again to Fig. 5 and Fig. 6 in order to further strengthen clamping
Clamping auxiliary device 500, clamping auxiliary device 500 include clamping auxiliary member 510 and clamping sub-arm 520.It pushes away for convenience
It send, in clamping also settable 4th handle 501 in 520 proximal end of sub-arm.
Along sub-arm accommodating chamber 250 is axially arranged in push conduit 210, i.e., selected in multiple inner cavities of push conduit 210
It selects one and is used as sub-arm accommodating chamber 250.Before puncture, clamps auxiliary member 510 and clamping sub-arm 520 is all housed in sub-arm
In accommodating chamber 250.As shown in figure 9, on the clamping face of proximal end collet 320, push conduit 210 side wall or proximal end collet 320
Side wall be provided with opening 260, opening 260 is connected with sub-arm accommodating chamber 250, when operator is to the 4th handle of distal end push
501, it can drive clamping sub-arm 520 that clamping auxiliary member 510 is pushed to stretch out from opening 260.
Referring to Figure 10, it clamping push rod 330 and punctures push rod 420 and is threaded onto push conduit 210 jointly, 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.In order to mitigate patient's damage, the heart for reducing patient is cut
Mouthful, the entire outer diameter of push conduit 210 should be minimized, therefore preferably 250 setting of sub-arm accommodating chamber is received in clamping push rod
Between cavity 280 and puncture push rod accommodating chamber 270.
As shown in figure 11, when puncture, clamping push rod 330 and leaflet EDGE CONTACT, distal end collet 310 and proximal end collet 320
It is only capable of clamping part leaflet, it, need to be in leaflet and leaflet edge 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 provides support force, it is therefore desirable to make to clamp auxiliary member 510 and push that there is certain angle between conduit 210,
The lower surface of the side leaflet opposite with leaflet edge can be supported on.Therefore, the distal portion and push of sub-arm accommodating chamber 250
The range of angle is 120-150 ° between the axial direction of conduit 210.
It is as shown in figure 12 a kind of embodiment of sub-arm accommodating chamber 250, sub-arm accommodating chamber 250 is generally flat
Cavity, entire sub-arm accommodating chamber 250 are obliquely installed in push conduit 210, and 250 distal portion of sub-arm accommodating chamber and push
Angle α range between the axial direction of conduit 210 is 120-150 °.
It is as shown in figure 13 250 another embodiment of sub-arm accommodating chamber, sub-arm accommodating chamber 250 includes distal end 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 and proximal end cavity
Angle γ range between 252 is 120-150 °.As long as guaranteeing to seamlessly transit between distal end cavity 251 and proximal end cavity 252, no
Influence clamping 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.
Clamping auxiliary device 500 includes clamping sub-arm 520 and the clamping auxiliary member set on clamping 520 distal end of sub-arm
510.Clamping auxiliary member 510 is made of elasticity and/or flexible material, to adapt to the anatomical structure of leaflet and the movable width of leaflet
Degree, and avoid damage to leaflet.Such as it can choose metal material, polymer material or Metal polymer composite and be made.
Elastic material is preferably shape-memory material.
As shown in figs. 14-15, auxiliary member 510 is clamped in the present embodiment is the rod-shaped knot being made of at 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 14
For the rod-like structure that a support rod is constituted, it is rod-shaped that the clamping auxiliary member 510 in Figure 15 is that two support rods arranged side by side are constituted
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, the whole light of clamping auxiliary member 510
It is sliding, smooth round end can be distally formed by laser spot welding, the defects of without burr, seamed edge, corner angle.The clamping of rod-like structure is auxiliary
The diameter of assistant piece 510 should be greater than the diameter of clamping sub-arm 520, to form stable support to leaflet.As shown in figure 11, to be held
After auxiliary member 510 is pushed out from 210 distal end of push conduit or 320 distal end of proximal end collet, clamping auxiliary member 510 is supported on leaflet
There is elasticity or clamping auxiliary member 510 flexible can comply with the movable amplitude of leaflet, will not cause because of too hard for lower surface
Perforation of valve cusp is stabbed.
Clamping sub-arm 520 is the body of rod with axial length, can be the hollow of single layer or multi-layer compound structure or
The metallic rod or high score sub bar of solid construction, can also be formed by individual thread or multi-filament coiling.For example, the clamping in Figure 14
Sub-arm 520 is a bar, and the clamping sub-arm 520 in Figure 15 is two bodies of rod arranged side by side.The section for clamping sub-arm 520 can
Think regular circle or ellipse, crescent, the partially circular, polygonal or shapes such as annular, it is preferably circular.It clamps auxiliary
Arm 520 is helped preferably to be made of the material with memory function, it can be by metal material, polymer material or metal-polymer
Composite material is made.Sub-arm 520 is clamped to be mounted in advance in the sub-arm accommodating chamber 250 of push conduit 210.Clamp sub-arm 520
Should have certain degree of hardness or rigidity with provide a supporting and can pushability, clamping auxiliary member 510 can be supported, and movement can be passed through
4th handle 501 drives entire clamping auxiliary device 500 to withdraw to distal end movement or proximally.
Clamping auxiliary member 510 and clamping sub-arm 520 can be integrated molding integral structure obtained, can also be by not
It is detachable or be detachably fixed and link together.Non-dismountable fixation refers to that clamping sub-arm 520 and clamping auxiliary member 510 first divide
It is fixed together again by forms such as welding, bondings after not processing not individually.It is detachably fixed and refers to clamping 520 He of sub-arm
After clamping the first individually processing of auxiliary member 510, it is fixed together by forms such as socket, threaded connection, interference fits.
Above-mentioned connection type is routine techniques, and details are not described herein.
Clamping auxiliary member 510 and clamping sub-arm 520 can be used different materials and be respectively prepared.That is, clamping sub-arm
520 be the rod-shaped or tubular structure of hard；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 elastic and/or flexible auxiliary
Help arm body 521 and the rigid support body 522 (as shown in figure 16) set on auxiliary arm body 521 internally and/or externally.Support
Body 522 is 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 make
Use relatively soft material that the whole body of rod or tube body is made as the clamping auxiliary member 510 and sub-arm in clamping auxiliary device 500
Then main body 521 is assisting the inner cavity of arm body 521 to wear the higher inner tube of hardness or in the part of auxiliary arm body 521
Outer surface is arranged or is set side by side the higher outer tube of hardness as supporter 522 to improve clamping 520 close end of sub-arm
Supportive；Relatively soft 521 outer surface of auxiliary arm body can also be wrapped in as supporter 522 using heat-shrink tube, then plus
Heat is wrapped in the outer surface of auxiliary arm body 521 to improve supportive after shrinking heat-shrink tube.It will also be appreciated that for list
Arm body 521 is assisted made of root silk or multi-filament coiling, the thermoplastic elastomer (TPE)s such as Pebax first can also be wrapped in auxiliary
The partial outer face of arm body 521, then heating is wrapped in outer surface after melting thermoplastic elastomer (TPE) while infiltrating into more
It is auxiliary to improve in gap between silk or individual thread (that is, supporter 522 is set to auxiliary arm body 521 outwardly and inwardly)
Help the supportive of arm body 521.
Clamping auxiliary member 510 does not transmit X-ray material preferably and is made.In the prior art, in gripping means grips valve
Before leaf, the lower mode of rank cannot be required to judge the relative position between instrument and leaflet by operations such as X-rays, needed
Clamping device could be moved to suitable position by relying on accurately ultrasonic guidance, 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, and operating difficulty is caused to increase
Greatly, operating time increases, so that increasing patient the risk of complication occurs.The clamping auxiliary member 510 and leaflet of the present embodiment
After contact, clamping auxiliary member can generate corresponding swing with the movable amplitude of leaflet, therefore in gripping means grips valve
Before leaf, operator can rapidly and accurately judge the position of leaflet by X-ray, so that more rapidly accurately operation clamping fills
It sets to clamp leaflet, shortens operating time, improve 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 17, the distal end collet 310 of artificial cords implant system and proximal end collet 320 are advanced into
In atrium sinistrum；
Step 2: referring to Figure 18, it proximally withdraws push conduit 210 or pushes clamping push rod 330 to distal end, so that
Proximal end collet 320 is separated with distal end collet 310, forms leaflet accommodation space therebetween；
Step 3: pushing the 4th handle 501 to distal end, the 4th handle 501 driving clamping sub-arm 520 pushes away referring to Figure 19
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；It 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 between proximal end collet 320 and distal end collet 310, and is pressed from both sides
Certain support force can be provided leaflet by holding auxiliary member 510；
Step 4: referring to fig. 20, the distal end of slight mobile artificial cords implant system, until leaflet edge and clamping push rod
330 contact, second handle 301 of proximally dropping back at this time, and proximally collet 320 is mobile until the two is closed for driving distal end collet 310
It closes, leaflet is clamped；
Step 5: referring to fig. 21, third handle 401 is pushed to distal end, the tapered distal end of driving piercing needle 410 pierces through valve
The hook-shaped body hook of leaf 900, piercing needle 410 takes artificial cords 100；
Step 6: referring to fig. 22, third handle 401 of dropping back, so that piercing needle 410 drives artificial cords 100 to pass through valve
Leaf moves to the near end, and Non-slip material 130 is also drawn out via clamping push rod 330 and distal end collet 310, the binding face of Non-slip material 130
(that is, lower surface) is contacted with the upper surface of leaflet, while partial artificial cords 100 push down the upper surface of Non-slip material 130 makes it
It is bonded leaflet (as shown in figure 23), at this point, the point contact between artificial cords 100 and leaflet is converted into Non-slip material 130 and valve
Face contact between leaf can effectively reduce the risk of leaflet tearing；
Step 7: the 4th handle 501 of recession, drives clamping auxiliary member 510 to withdraw into sub-arm accommodating chamber 250, withdraws from
Entire artificial cords implant system, and the length for staying in the artificial cords 100 in heart is adjusted, by the closure of artificial cords 100
One end of structure is fixed in ventricle wall (as shown in figure 24), completes artificial cords implantation.
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.
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,
Difference place is: in the present embodiment, clamping auxiliary member 510 is the distressed structure being made of more support rods, and distressed structure exists
It is contained in push conduit 210 jointly after contraction distortion with clamping sub-arm 520.
Specifically, distressed structure is the open bifurcation structure or umbrella-shaped structure being made of more support rods.Clamping
Auxiliary member 510 has extended state when compressive state and nature, and in compressive state, clamping auxiliary member 510 can pushed away
It send in the sub-arm accommodating chamber 250 of conduit 210 and pushes；After clamping auxiliary member 510 by stretching out in opening 260, it is changed into stretching, extension
State may be supported on the lower surface of leaflet, stablize leaflet, be conducive to puncture.This clamping auxiliary member 510 being relatively large in diameter and leaflet
Contact surface be the plane clamped where auxiliary member 510, therefore, clamp the contact area between auxiliary device 500 and leaflet
It is bigger, it can be preferably bonded leaflet, improve clamping auxiliary device 500 to the supportive of leaflet.
As shown in figure 25, clamping auxiliary member 510 is by two support bar groups at angle between two support rodsRange is
20 ° -150 °, be preferably 60 ° -90 °, is proximally recycled to providing stable supportive and not influencing clamping auxiliary member 510
It pushes in conduit 210.Support rod has flexible and elasticity, receiving extremely push conduit 210 after two support rods can close up as a result,
Inner cavity in, after stretching out from opening 260, two support rods can restore to the bifurcation structure with certain angle to supporting
Leaflet.
In use, first bifurcation structure is received into push conduit 210, clamping sub-arm 520 receiving to push conduit 210
In sub-arm accommodating chamber 250, the proximal end of proximal end from push conduit 210 is pierced by and is connected with the 4th handle 501.It is pushed to distal end
4th handle 501, clamping auxiliary member 510 is stretched out from opening 260, since its own flexibility and/or elasticity are changed into nature
Extended state (that is, restoring bifurcation structure) under state, is supported on the lower surface of leaflet；When proximally withdrawing four handles 501,
Two support rods of bifurcation structure close up, and entire bifurcation structure is pulled in the sub-arm accommodating chamber 250 of push conduit 210.Folder
It holds sub-arm 520 and clamping auxiliary member 510 can be integrally formed overall structure, it can also be to be assembled in one again after separately formed
It rises.
It is understood that in other embodiments, can also be installed on jointly and be pushed away by least two clamping sub-arms 520
It send in a sub-arm accommodating chamber 250 of conduit 210, a support rod is distally arranged as clamping in each clamping sub-arm 520
Auxiliary member 510.Multiple clamping auxiliary members 510 are pierced by via the same opening 260 as a result, and have certain angle each other,
Branch type structure or beveled structure are formed, the lower surface of leaflet is supported on, more effective support is provided.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 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 26.
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.
Embodiment three
The structure of the artificial cords implant system of the artificial cords implant system and embodiment two of the present embodiment is essentially identical,
Difference place is, in the present embodiment, the clamping auxiliary member 510 positioned at clamping 520 distal end of sub-arm is by more support rod structures
At closing structure, closing structure can be circle, diamond shape, ellipse, pyriform, polygon or other are irregular but can be with shape
At the shape of enclosed construction, as shown in Figure 27 a-27c.As shown in Figure 28 a and Figure 28 b, clamping auxiliary member 510 pushes conduit certainly
After 210 distal ends are stretched out, the contact area between leaflet 600 is bigger, more preferable to the supportive of leaflet 600.
It is understood that at least one tool can also be arranged in other embodiments, between the support rod of closing structure
Flexible and/or elastic connecting rod 511 further enhances clamping auxiliary member 510 to improve the self stability of closing structure
To the support force of leaflet, as shown in figure 29.
It will also be appreciated that in other embodiments, when more support rods and connecting rod are arranged in closing structure,
Closing structure 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, branch
Support is in leaflet lower surface.
To sum up, the artificial cords implant system with clamping auxiliary device of the invention, by being implanted into system in artificial cords
Increase clamping auxiliary device in system, after leaflet is lived by distal end collet and proximal end grips, clamping auxiliary member may be supported on valve
Leaflet is held up to atrial side, and then reduces leaflet movable amplitude by the lower surface of leaf, and clamping device is assisted to stablize the valve of beating
Leaf.Also, if operator has found that clip position is undesirable, clamping device can be finely tuned, during fine tuning, clamping auxiliary
The supporting role of device can prevent leaflet from slipping from clamping device.
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 (10)
1. the artificial cords implant system with clamping auxiliary device, including push conduit, clamping device, sting device and clamping are auxiliary
Help device, the clamping device include be equipped with artificial cords clamping push rod and for cooperate clamping leaflet distal end collet and
Proximal end collet, the sting device include that at least one punctures push rod and the piercing needle set on the puncture push rod distal end,
Be characterized in that: the clamping push rod and the puncture push rod are actively installed on respectively in the push conduit, the puncture needle
Head has tapered distal end and hook-shaped body, and the clamping auxiliary device includes the clamping being actively installed in the push conduit
Sub-arm and clamping auxiliary member set on the clamping sub-arm distal end, the clamping sub-arm promotion clamping auxiliary member from
The push distal end of catheter or proximal end collet distal end are stretched out, the clamping auxiliary member and clamping device cooperation clamping valve
Leaf.
2. artificial cords implant system according to claim 1, which is characterized in that the clamping auxiliary member by elasticity and/
Or flexible material is made.
3. artificial cords implant system according to claim 2, which is characterized in that the clamping auxiliary member is by not Transmission X
Ray material is made.
4. 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 constituted, 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 being made of more support rods, the distressed structure be selected from bifurcation structure,
At least one of umbrella-shaped structure, closing structure, 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.
5. 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 and/or auxiliary arm body flexible and is set to the sub-arm body exterior
And/or internal rigid support body.
6. 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 angular range between the distal portion of the sub-arm accommodating chamber and the axial direction of the push conduit is 120-
150°。
7. artificial cords implant system according to claim 1, which is characterized in that the proximal end collet setting is pushed away described
The distal end of conduit is sent, the distal end collet is arranged in the distal end of the clamping push rod, is equipped with artificial cords in the distal end collet
Accommodating chamber, the artificial cords accommodating chamber are connected with the inner cavity of the clamping push rod.
8. artificial cords implant system according to claim 7, which is characterized in that edge is axially arranged in the distal end collet
Puncture channel, the distal end of the puncture channel are penetrated through to the artificial cords accommodating chamber, and the piercing needle leads to from described puncture
Road hooks after being pierced by and takes the artificial cords；
Or the artificial cords accommodating chamber is penetrated through to the clamping face of the distal end collet, the piercing needle is pressed from both sides from the proximal end
The clamping face of head hooks after being pierced by and takes the artificial cords.
9. artificial cords implant system according to claim 1, which is characterized in that the artificial cords are what both ends were connected
Closed loop configuration.
10. artificial cords implant system according to claim 9, which is characterized in that the artificial cords are equipped with anti-skidding
Part, the Non-slip material have the binding face being bonded with leaflet, at least two through-holes, the artificial cords are arranged on the Non-slip material
Both ends be each passed through after the different through-holes and be connected, the Non-slip material is contained in the clamping push rod or the distal end presss from both sides
In head.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201711288779.1A CN109893297B (en) | 2017-12-07 | 2017-12-07 | Artificial chordae tendineae implantation system with clamping auxiliary device |
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|---|---|---|---|
| CN201711288779.1A CN109893297B (en) | 2017-12-07 | 2017-12-07 | Artificial chordae tendineae implantation system with clamping auxiliary device |
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| CN109893297B CN109893297B (en) | 2020-11-24 |
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| CN110353821A (en) * | 2019-06-20 | 2019-10-22 | 上海汇禾医疗科技有限公司 | Instrument and clamp assemblies |
| CN112773561A (en) * | 2020-01-23 | 2021-05-11 | 北京领健医疗科技有限公司 | Valve repair device |
| WO2021109616A1 (en) * | 2019-12-06 | 2021-06-10 | 杭州德晋医疗科技有限公司 | Valve suture device and valve repair suture device |
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| CN109893297B (en) | 2020-11-24 |
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