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CN103462728B - A kind of aortic valve prosthesis's holder and its transport system through conduit implantation - Google Patents

A kind of aortic valve prosthesis's holder and its transport system through conduit implantation Download PDF

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Publication number
CN103462728B
CN103462728B CN201310417098.6A CN201310417098A CN103462728B CN 103462728 B CN103462728 B CN 103462728B CN 201310417098 A CN201310417098 A CN 201310417098A CN 103462728 B CN103462728 B CN 103462728B
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China
Prior art keywords
holder
gland
leaflet
valve prosthesis
aortic valve
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Expired - Fee Related
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CN201310417098.6A
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CN103462728A (en
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刘文修
吴言革
吴俊龙
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XUZHOU YATAI SCIENCE & TECHNOLOGY Co Ltd
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XUZHOU YATAI SCIENCE & TECHNOLOGY Co Ltd
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Publication of CN103462728A publication Critical patent/CN103462728A/en
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Abstract

The present invention provides a kind of aortic valve prosthesis's holder being implanted into through conduit, including holder and artificial valve, holder is in " dumbbell shaped " structure by the establishment of elastotic material, including head, waist and tail portion, one layer of non-biocompatible thin film is covered in the outer surface of carrier head, holder tail portion is equipped with installation anchor.A kind of transport system for conveying the holder is also provided, is made of epitheca, inner core, loader, push rod and gland, the installation anchor of wherein holder tail portion is installed on gland, is transported to aortic valve prosthesis's holder in vivo by puncture method.The holder is closer to physiological anatomic architecture, self-inflated is detached from, using bioprosthesis valve, it is energized close to artificial valve, and from the transport system can slightly be transformed by the transport system of congenital heart disease occluder, so that the equipment of interventional treatment structural heart disease gradually standardized, standardized, while also economizing on resources, reducing consumption.

Description

A kind of aortic valve prosthesis's holder and its transport system through conduit implantation
Technical field
The invention belongs to medical instruments field, relate in particular to a kind of aortic valve prosthesis's holder being implanted into through conduit and Its transport system.
Background technology
With the arrival of aging population society, aortic stenosis will become one of most common adult's valve disease. Surgical valve replacement is the only effective treatment means, can improve patient symptom and sign, extends the service life.Even if sending out Still it cannot carry out surgical operation because of advanced age and a variety of complication there are many severe aortic stenosis patient up to country and control It treats, while thering are some patientss to be reluctant to perform the operation because worrying postoperative complication.Cribier etc. reports the 1st in December, 2002 For human body through conduit aortic valve replacement, this technology is gradually applied to clinic at present, is likely to become a kind of new aorta petal Narrow therapy.But this technology at present still there are many problem have it is to be solved, such as valve bracket fixation, valve periphery The service life etc. of leakage and artificial valve.
Heart valve prosthesis is increasingly used for treatment heart valve disease since the sixties in 19th century.The artificial heart Dirty valve includes artificial mechanical valve prosthesis and bioprosthesis valve (abbreviation biovalve or bioprosthetic valves).Bioprosthetic valves are by leaflet and frame A kind of heart valve prosthesis of body composition.Leaflet is the moving part of valve opening and closing, generally chemically treated with ox or Pigs Hearts packet The stabilization boiomacromolecule combined material formed afterwards is made.Valve frame then plays configuration, support and load.The shape of bioprosthetic valves Similar to human body heart valve, flow pattern belongs to center flow pattern, and flow field characteristic is also close to human body heart valve.The anti-hemolysis and antithrombotic of bioprosthetic valves The better performances of formation, but due to material (as generate calcification) and valve type design it is not reasonable, bioprosthetic valves are portion Ground is divided to achieve the purpose that improve heart valve performance.And as the processing and fabricating of its core valve frame, there are no more unite One standard, no matter design or processing and fabricating on all also in the exploratory stage.With heart valve prosthesis flow field theory and Biomaterial theoretical research deepens continuously, around the biovalve leaflet mechanical property for improving bioprosthetic valves service life and being unfolded It can analyze and valve frame precise forming processing method research shows wide foreground.
Current implantable prosthetic valve has surgical operation implantation, through the methods of conduit implantation and percutaneous puncture implantation, still Surgical implantation art uses surgery throacotomy, and wound is big, and operation risk is high, and advanced age merges symptom and is unable to surgical operation, some patientss To the mental handicape person of surgical complications, therefore, surgical implantation art is limited larger.It is existing to be implanted into stainless steel valve through conduit Membrane support need to be implanted valve bracket by way of balloon expandable, this method easily causes cardiac tamponade, the heart because of balloon expandable The risk of the severe complications such as flesh infarct.And percutaneous puncture direct motion method is implanted into, for the program because puncturing atrial septum, operation is more multiple It is miscellaneous, bicuspid valve may be caused to damage, mechanical stress acts on valve bracket and surrounding tissue, easily causes the possibility of perivalvular leakage.
Invention content
The present invention is to provide a kind of aortic valve prosthesis's holder that can be implanted into through conduit and its transport system.The present invention provides Technical solution it is as follows:
A kind of aortic valve prosthesis's holder being implanted into through conduit is in " dumbbell shaped " structure by the establishment of elastotic material, Including head 1, waist 2 and tail portion 3, head is proximal part, cylindrical, at a diameter of 18-22mm, with aortic root annulus Shape matches;Waist 2 is recessed inwardly, and mesh is expanded, corresponding with coronary ostium;Tail portion 3 is cylindrical, with liter Aorta is corresponding, which is characterized in that covers one layer of non-biocompatible thin film 4 in the outer surface of carrier head, holder tail portion is equipped with Anchor 7 is installed.
Preferably, non-biocompatible thin film 4 is polytetrafluoroethylene (PTFE), polyurethane or polyethylene film.
Preferably, biovalve 5, backing positions corresponding with the leaflet of biovalve 5 are housed in the inside of carrier head There are openings 6 at place.It is highly preferred that the biovalve 5 is in three leaf semilunar valve structures 14, it is corresponding with the leaflet of biovalve 5 Opening 6 there are three being stayed at backing positions.It is highly preferred that each leaflet 15 be in 120 degree of fan-like structures, with three leaflets 15 pair Three openings 6 answered are distributed in same plane in 120 degree of angles.As the more preferred of biovalve 5, leaflet has arc Face 16, mountain peak part 17 and obtuse angle part 18, cambered surface 16 and mountain peak part 17 are fixed with holder suture, and obtuse angle part 18 is activity Leaflet, the centripetal face 19 of leaflet are in convex surface, leaflet to aorta ascendens face 20 be in concave surface.
Preferably, holder tail portion is set there are three anchor 7 is installed, and for three installation anchors 7 in 120 degree of distributions, installation anchor 7 is by stainless The component that Steel material makes, the component are made of metal cuboid 11 and seal wire 12, and 12 one end of seal wire is welded in cuboid 11 Between position, the other end is welded in holder tail end, and blunt cuboid upper surface corner angle 13 are in arc-shaped.
Preferably, the fibrous material for aortic valve prosthesis's holder that establishment is implanted into through conduit is that high resiliency NiTi is selected to close Spun gold.
Invention of the present invention also provides a kind of transport system, for conveying aforementioned aortic valve prosthesis's holder, by epitheca, interior Core, loader, push rod and gland composition, which is characterized in that epitheca is made of sheath 24 and sheath pipe fitting 25, sheath it is remote End 23 has closing in, proximal end to be connect with sheath pipe fitting 25;Inner core is made of inner catheter 22 and inner core connector 26, the distal end 21 of inner catheter At tip configurations, proximal end is connect with inner core connector 26;Loader is by short sheath 29, fastening connector 30, sheath pipe fitting 31 and hemostasis Valve 32 forms;Push rod is made of spring-guide wire 28, precision screw 27 and handle 33;Gland 9 is the circle by stainless steel material Cylinder has accurate screw hole 10 at proximal hub, which can realize that spiral be connect with the precision screw 27 of push rod distal end, The diameter of gland 9 is used cooperatively with epitheca, and diameter is less than epitheca bore, and gap is 0.1 ~ 0.15mm, in gland 9 Distal outer surface there is square groove 8, which can put into the installation anchor 7 of holder tail end in slot and take in sheath.
The tail portion of embodiment more preferably, aortic valve prosthesis's holder is set there are three anchor 7 is installed, and three are pacified Anchor 7 is filled in 120 degree of distributions, installation anchor 7 is the component made by stainless steel material, and the component is by metal cuboid 11 and seal wire 12 Composition, and three square grooves 8 are distributed according to 120 degree of angles in the distal outer surface of gland, the cuboid 11 of installation anchor 7 can be placed It is interior without exposed in the square groove 8 of gland 9.
Advantageous effect:
1. since aortic valve prosthesis's holder uses " dumbbell shaped ", more close to Physiological Anatomy structure, the head of holder Portion is installed on shape at aortic root annulus and matches, and tail portion is installed on aorta ascendens opening, and holder fixation is not easy Displacement.
2. since holder is in " dumbbell shaped ", waist bracket is recessed inwardly and mesh grid is sparse, mesh is larger, and coronal dynamic Arteries and veins opening is corresponding, reduces the insufficient influence of coronary blood flow, reduces the risk of myocardial infarction.
3. there are three opening, three openings to be distributed in around holder,head and be in for carrier head part corresponding with leaflet 120 degree of angle distributions are simultaneously corresponding with leaflet, prevent valve from fully opening with touch-proof holder when leaflet is opened, carrier openings energy To valve there are the activity space of bigger, leaflet opening angle increases, and blood flow is unobstructed, vortex is few.
4. the carrier head outer surface is covered with film, which is sutured in rack outer surface, can prevent perivalvular leakage, can drop The risk of low aortic regurgitation.
5. the valve of the artificial aortic valve stent uses bovine pericardium or Pigs Hearts packet valve, because of the blood of its biomaterial Compatibility is preferable, is destroyed seldom to blood component, and thromboembolism incidence is low, postoperative to be not necessarily to lifelong anti-freezing, to avoid because anti- Hemorrhage complication caused by the solidifying drug amount of exceeding, suitable for thering is hemorrhagic tendency, the women of child-bearing age and remote villages area to be not easy to carry out The case of anticoagulant therapy.
6. due to using biovalve, leaflet category surface of revolution moulding, three leaflets to be distributed in 120 degree of angles, during which belongs to Painstaking effort flow pattern, close to normal artificial valvular function, haemodynamics is functional, to be close to or up to the natural heart valve of human body Performance.
It 7. the installation anchor of the holder is T-type structure, can be used cooperatively, be realized in sheath to valve branch with gland Frame reels movement, while gland is that spiral is connect with push rod, and the gland of different-diameter is replaced according to sheath specification, When clinical application, specification and sheath specification according to valve bracket determine to select corresponding gland, can save material reduction Cost.
8. the holder uses high resiliency nitinol alloy wire, reaches self-expanding after being transported to target site and be detached from transport system Effect.
9. the transport system of the artificial valve bracket can be slightly transformed by the transport system of congenital heart disease occluder and It obtains, so that the equipment of interventional treatment structural heart disease gradually standardized, standardized, while also economizing on resources, reducing consumption.
Description of the drawings
Fig. 1 is the schematic diagram of artificial aortic valve stent;
Fig. 2 is the schematic diagram after artificial aortic valve stent is shunk;
Fig. 3 is the front view of gland;
Fig. 4 is the longitudinal sectional figure of gland;
Fig. 5 is the cross-sectional view of gland;
Fig. 6 is the side view for installing anchor;
Fig. 7 is the front view for installing anchor;
Fig. 8 is the schematic diagram of artificial valve;
Fig. 9 is the front view of leaflet;
Figure 10 is the side view of leaflet;
Figure 11 is transport system schematic diagram;
Figure 12 is loader and push rod assembling schematic diagram;
Figure 13 is installation anchor and sectional view of the gland in sheath.
In figure:1 head;2 waists;3 tail portions;4 films;5 biovalves;6 openings;7 installation anchors;8 square grooves;9 glands; 10 screw holes;11 cuboids;12 seal wires;13 corner angle;14 3 leaf semilunar valve structures;15 leaflets;16 cambered surfaces;17 mountain peaks part;18 is blunt Angle part;19 centripetal faces;20 to aorta ascendens face;21 inner catheters distal end;22 inner catheters;23 sheaths distal end;24 sheaths;25 sheaths Connector;26 inner core connectors;27 screws;28 seal wires;29 short sheaths;30 fastening connectors;31 sheath pipe fittings;32 haemostatic valves;33 handles.
Specific implementation mode
Below in conjunction with attached drawing, present invention be described in more detail.It will be appreciated that institute's graph plotting type and the explanation that is provided are only It is that the present invention will be described for example preferably, and should not be construed as constituting protection scope of the present invention and limit System, protection scope of the present invention is only by claims limited.
1. structure explanation
Aortic valve prosthesis's holder of the present invention includes holder and artificial valve, and the holder is by high resiliency Nitinol Silk establishment is in " dumbbell shaped " structure, including head 1, waist 2 and tail portion 3, as shown in Figure 1.Head 1 is proximal part, cylindrical, Match with shape at aortic root annulus;Waist 2 is recessed inwardly, and mesh is expanded, corresponding with coronary ostium; Tail portion 3 is cylindrical, with aorta ascendens to corresponding.Its head diameter is 18-22mm, as shown in Fig. 2, when stent collapses, it can To take in the sheath of 14F or 16F, it is implanted by vascular routes.The outer surface of carrier head cover one layer of biocompatibility compared with Good film 4, such as polytetrafluoroethylene (PTFE), polyurethane, polyethylene, the film can effectively prevent perivalvular leakage.As shown in figure 8, The inside of carrier head is equipped with biovalve 5, and as seen from Figure 1, there are opening 6 at backing positions corresponding with leaflet, three are opened Mouth is distributed in same plane in 120 degree of angles, and holder is touched to prevent leaflet when valve open state, is conducive to the unlatching for increasing valve Angle.Referring to Fig. 3-7, holder tail portion can be positioned over there are three anchor 7, the installation anchor is installed 8 in the square groove of gland 9, fixed There is accurate screw hole 10 at the proximal hub of head, which can connect with the precision screw 27 of push rod distal end.It is by not to install anchor The precise part that the Steel material that becomes rusty makes, the component are made of metal cuboid 11 and seal wire 12, and seal wire one end is welded in cuboid Centre position, the other end is welded in holder tail end, and three installation anchors, in 120 degree of distributions, cuboid upper surface corner angle are blunt In arc-shaped 13, which can ensure to slide freely in sheath, the cuboid be positioned in the square groove of gland without It is exposed.Referring back to Fig. 9 and 10, the artificial valve 5 is in three leaf semilunar valve structures 14, and each leaflet 15 is in 120 degree of fan-shaped knots Structure, the cambered surface 16 of leaflet and mountain peak part 17 are fixed with holder suture, and obtuse angle part 18 is activity leaflet, the centripetal face 19 of leaflet In convex surface, leaflet is in concave surface to aorta ascendens face 20, and three leaflets realize heart contraction unlatching, diastole in 120 degree of distributions The function of closing.
Referring to Figure 11 and 12, transport system is made of epitheca, inner core, loader, push rod and gland.Epitheca is by sheath 24 and sheath pipe fitting 25 form, the distal end 23 of sheath has closing in, proximal end to be connect with sheath pipe fitting 25;Inner core is by inner catheter 22 and interior Core connector 26 forms, and at tip configurations, proximal end is connect with inner core connector 26 for the distal end 21 of inner catheter;Loader by short sheath 29, It fastens connector 30, sheath pipe fitting 31 and haemostatic valve 32 to form, push rod has 33 groups of spring-guide wire 28, precision screw 27 and handle At;Gland 9 can realize that spiral is connect with push rod, and diameter and the epitheca of gland are used cooperatively, and diameter is less than epitheca Bore, gap 0.1-0.15mm replace corresponding gland depending on the sheath of different size, and gland is by stainless steel The cylinder of material has accurate screw hole at proximal hub, which can connect with the precision screw spiral of push rod distal end, Three square grooves are distributed according to 120 degree of angles in the distal outer surface of gland, which can put the installation anchor of holder tail end into It in slot and takes in sheath as shown in figure 13, and the automatic spring under self-expanding state.
2, material explanation
Holder category self-expandable stent of the present invention, is woven by high resiliency nitinol alloy wire;Valve member uses Biovalve is packed by animal tissue's such as bovine pericardium, Pigs Hearts;Anti- perivalvular leakage film category high molecular material such as polytetrafluoroethylene (PTFE), Polyurethane and polyethylene etc.;Suture often uses polyester suture line using surgery;It is Stainless steel 316 L and NiTi conjunction to install anchor member Gold.
The transport system is similar to plugging device transport system, increases the gland being connect with push rod, transport system institute It is polytetrafluoroethylene (PTFE), polyethylene, ABS, stainless steel etc. with material.
3, description of the process
The holder is obtained under shaper through high-temperature shaping by nitinol alloy wire hand woven;Artificial valve is with fresh Bovine pericardium or Pigs Hearts packet are material, and after de- cell, a series of biochemistry treatments such as go toxicity, pericardium is cut into leaflet, Through shape in curved surface of shaping, then it is sewn to the specified position of holder;Anti- perivalvular leakage film is sutured in bracket outer.Anchor is installed by mechanical essence Close processing and fabricating is connect with nitinol alloy wire laser welding.
The processing technology of transport system is identical as the processing technology of plugging device transport system, and gland is added through mechanical precision Work makes.
4, operation principle
It is in swelling state in its natural state since the holder of the present invention is woven using high resiliency nitinol alloy wire, Can be taken under external force pressure in sheath is in a linear.Three installation anchors of holder tail portion are positioned over the square groove of gland It is interior, due to gland diameter and sheath bore clearance fit, head is connected and fixed by push rod, reels push rod artificial valve branch Frame is free to slide in sheath, when valve bracket releases sheath, due to the self-expanding performance of holder, successively occur head expansion, Waist expander, last tail portion expansion plant artificial valve holder in internal to drive three installation anchors to be detached from gland.By Surface of revolution moulding, to be close to or up to the performance of the natural heart valve of human body, blood flow directive master when the heart contracts are used in leaflet Artery, valve is opened, and when diastole, valve is closed, three leaflet uniform forces and circumferential stress is smaller, and it is dynamic to meet heart valve Theory of mechanics realizes the keying function of artificial valve, meets cardiophysiology requirement, achieve the purpose that treatment.
5, operating instruction
When percutaneous puncture, under X-ray line, delivery sheath head is placed at aortic valvular ring using Retrograde, selection with The corresponding gland of sheath specification is connect with push rod spiral, and three installation anchors of artificial valve holder are positioned over gland In square groove, post-tensioning push rod takes in artificial valve holder in loader, to interior push push rod, valve after being connect with epitheca Holder reaches the head for exposing holder at aortic valvular ring, the head position for adjusting holder is moderate, continues to push away in sheath in-pipe Send holder while sheath of dropping back, artificial valve holder is automatically disengaged with gland, and artificial valve holder is planted in internal.
Embodiments of the present invention are described in detail above in conjunction with attached drawing, but the present invention is not limited to above-mentioned implementations Mode, technical field those of ordinary skill within the scope of knowledge, present inventive concept can also not departed from Under the premise of make a variety of changes.

Claims (7)

1. a kind of aortic valve prosthesis's holder being implanted into through conduit, including holder and artificial valve, wherein holder is by elastomer The establishment of shape material is in " dumbbell shaped " structure, including head(1), waist(2)The tail portion and(3), head is proximal part, cylindrical, Shape matches at a diameter of 18-22mm, with aortic root annulus;Waist(2)It is recessed inwardly, and mesh is expanded, with hat Shape arterial ostium is corresponding;Tail portion(3)It is cylindrical, it is corresponding with aorta ascendens, which is characterized in that in the appearance of carrier head Cover one layer of non-biocompatible thin film in face(4), holder tail portion is equipped with installation anchor(7), biovalve(5)In carrier head Portion, with biovalve(5)The corresponding backing positions of leaflet at there are openings(6), wherein the biovalve(5)In three leaves half Month valve structure(14), with biovalve(5)The corresponding backing positions of leaflet at stay there are three opening(6), wherein the biology Compatible membranes(4)It is polytetrafluoroethylene (PTFE), polyurethane or polyethylene film.
2. the aortic valve prosthesis's holder being implanted into as described in claim 1 through conduit, which is characterized in that each leaflet(15)It is in 120 degree of fan-like structures, with three leaflets(15)Three corresponding openings(6)It is distributed in 120 degree of angles in same plane.
3. the aortic valve prosthesis's holder being implanted into as claimed in claim 2 through conduit, which is characterized in that leaflet has cambered surface (16), mountain peak part(17)And obtuse angle part(18), cambered surface(16)And mountain peak part(17)It sutures and fixes with holder, obtuse angle part (18)For activity leaflet, the centripetal face of leaflet(19)In convex surface, leaflet to aorta ascendens face(20)In concave surface.
4. the aortic valve prosthesis's holder being implanted into as described in claim 1 through conduit, which is characterized in that holder tail portion is equipped with three A installation anchor(7), three installation anchors(7)It is distributed in 120 degree, anchor is installed(7)It is the component made by stainless steel material, the component By metal cuboid(11)And seal wire(12)Composition, seal wire(12)One end is welded in cuboid(11)Centre position, other end weldering It is connected to holder tail end, cuboid upper surface corner angle(13)Blunt is in arc-shaped.
5. the aortic valve prosthesis's holder being implanted into through conduit as described in any one of the preceding claims, which is characterized in that should Elastotic material selection high resiliency nitinol alloy wire.
6. a kind of transport system for conveying aortic valve prosthesis's holder as described in claim 1, by epitheca, inner core, dress Carry device, push rod and gland composition, which is characterized in that epitheca is by sheath(24)With sheath pipe fitting(25)Composition, sheath it is remote End(23)There are closing in, proximal end and sheath pipe fitting(25)Connection;Inner core is by inner catheter(22)With inner core connector(26)Composition, inner catheter Distal end(21)At tip configurations, proximal end and inner core connector(26)Connection;Loader is by short sheath(29), fastening connector(30)、 Sheath pipe fitting(31)And haemostatic valve(32)Composition;Push rod is by spring-guide wire(28), precision screw(27)And handle(33)Composition; Gland(9)It is the cylinder made of stainless steel material, there is accurate screw hole at proximal hub(10), the screw hole(10)It can be with The precision screw of push rod distal end(27)Realize spiral connection, gland(9)Diameter be used cooperatively with epitheca, diameter is less than Epitheca bore, gap is 0.1 ~ 0.15mm, in gland(9)Distal outer surface have square groove(8), the square groove(8)Energy Enough installation anchors by holder tail end(7)It puts into slot and takes in sheath.
7. transport system as claimed in claim 6, which is characterized in that there are three the tail portion of aortic valve prosthesis's holder is set Anchor is installed(7), three installation anchors(7)It is distributed in 120 degree, anchor is installed(7)The component made by stainless steel material, the component by Metal cuboid(11)And seal wire(12)Composition, and in the distal outer surface of gland three square grooves are distributed according to 120 degree of angles (8), anchor is installed(7)Cuboid(11)Gland can be positioned over(9)Square groove(8)It is interior without exposed.
CN201310417098.6A 2013-09-13 2013-09-13 A kind of aortic valve prosthesis's holder and its transport system through conduit implantation Expired - Fee Related CN103462728B (en)

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