The stent valve of band tongue structure and the weaving method of support thereof
Technical field
The present invention relates to succedaneum of a kind of tissue and preparation method thereof, relate in particular to a kind of with the stent valve of tongue structure and the weaving method of support thereof.
Background technology
Heart is the most important organ of human body, and heart is divided into left and right sides two parts, and each part comprises atrium and ventricle again.Left atrium and left and right ventricles are separated by interatrial septum and interventricular septum respectively.In heart, there are four cardiac valve, i.e. Tricuspid valve, valve of pulmonary trunk, Bicuspid valve and aortic valve.In the blood of human body cycling mechanism, four cardiac valve play crucial effects.The anoxia blood of body cycling mechanism enters right atrium through caval vein, enter right ventricle by Tricuspid valve then, right ventricle shrinks blood is pressed into pulmonary circulation mechanism by valve of pulmonary trunk, get back to left atrium through the blood behind the lung oxygen saturation through pulmonary vein, arrive left ventricle through Bicuspid valve again, the left ventricle contraction enters aorta with blood by aortic valve and returns to the body cycling mechanism.Left and right sides coronary ostium is arranged under the aortic valve.Close when valve-open when four valvular structures have guaranteed blood along direction, contrary direction, prevented blood reflux and the heart burden that causes.But, because a variety of causes can cause valvular posteriority damage or pathological changes, as rheumatism, atherosclerosis etc.In addition, congenital heart disease such as fallot's disease, postoperative also can produce the cusps of pulmonary valve pathological changes long term.Show as valvular function after the valve pathological changes and lose gradually, cause blood reflux as valvular insufficiency, valvular stenosis causes blood circulation not smooth, or incompetence and narrow the two merger, so that increase the weight of the heart burden, causes cardiac failure.For valvular posteriority damage or pathological changes, traditional Therapeutic Method is out breast, after the cardiac arrest, under the cryotron outer circulation is supported, opens heart and carries out the surgical repair of pathological changes valve or use artificial cardiac valve replacement.Existing Cardiac valve prosthesis divides two big classes: metal mechanical valve prosthesis and biovalve.Biovalve is made after being handled by animal materials such as bovine pericardium, bovine jugular vein lobe, porcine aortic valve.The method of above-mentioned open heart operation, operating time is long, the expense height, wound is big, has a big risk, and metal mechanical valve prosthesis displacement back patient needs long-term anticoagulant therapy, and the material lifetime of biovalve is limited, needs operation more usually.
In order to solve the problem that above-mentioned open heart operation treatment cardiac valve exists, existing now people attempts not doing open heart operation, and adopts percutaneous interventional method or the defeated Cardiac valve prosthesis of putting of Minimally Invasive Surgery.The Cardiac valve prosthesis of prior art has two kinds:
1, balloon-expandable
This balloon-expandable Cardiac valve prosthesis is a biovalve, its interventional method is a difference fixed biologically valve on the support of a plastically deformable, diminishes by radial compression back diameter on a sacculus, and percutaneous is defeated to be put, pressurization makes the support expansion fixing to sacculus then, reaches duty.
Shortcoming and problem that balloon-expandable artificial valve exists are: its diameter is determined by balloon diameter, if artificial valve's diameter does not choose at the beginning, or after some physiological change, as self-sow, pathologic vessels expansion etc., the caliber size of nature valve may increase, and artificial valve's bore can not increase by adaptability, and the artificial valve has the danger of loosening or slippage, can only carry out the further expansion of secondary sacculus.
2, self expandable type
This artificial valve is provided with a strain support, can expand voluntarily after the radial compression.
Shortcoming and problem that the self expandable type artificial valve of prior art exists are: frictional force is big between self expandable type Cardiac valve prosthesis and sheath pipe, influences the artificial valve and accurately discharges.
Common drawback and problem that above-mentioned balloon-expandable and self expandable type Cardiac valve prosthesis exist are:
1, existing man-made support valve is harder under radial compression, and bendability is poor, is not easy through aortic arch, can not aim at nature aortic valve mouth.
Even if 2 under the x x ray fluoroscopy x helps, the axial upstream and downstream location of man-made support valve also is not easy because of unstable the becoming of artificial valve under and the blood flow impact inaccurate to the judgement of anatomical position.The resistance coronary ostium if swimming on the upper side, the prosthetic aortic valve position can influence Bicuspid valve, if downstream can be blocked up in the position.
3, the direction of rotation of aortic valve man-made support valve location fails to solve, if the prosthetic aortic valve position of rotation is not to blocking up the resistance coronary ostium.
4, in dispose procedure, stent valve partly is expanded to full expansion gradually, and required time surpasses a heart beat cycle.The stent valve of expansion can hinder blood flow, and stent valve also can make its position change because of blood flow impacts.Balloon-expandable man-made support valve complete blocking blood flow in the balloon expandable process particularly.
5, also there is following problem in the fixing of stent valve that discharges after expanding:
A) systole and the impact of relaxing period blood flow can make fixing bad man-made support valve move.
B) existing pathologic expansion before its aortic root art of the patient of some aortic incompetence needs very big stent valve to coincide fixing with it.
C) some patient implants the part, back at the man-made support valve and has anatomical and change, as expansion, make can not respective change stent valve lose effectively fixing.
6, the man-made support valve after expansion is fixed has perivalvular leakage (Para valvularleaks) under many circumstances, and promptly blood leaked between stent valve and blood vessel wall.
If 7, touch metal rack in the valve leaflet switch, can cause the valve leaflet wearing and tearing.
Can to bear very big stress if 8 adopt major diameter stent valve, lobe leaf to unite point (Commissure) in order fixing, to cause valve leaflet to unite and a little tear damage.
Summary of the invention
Purpose of the present invention is to overcome the problems referred to above that prior art exists, and a kind of stent valve of band tongue structure of new structure and the weaving method of support thereof are provided.
The object of the present invention is achieved like this: a kind of stent valve with tongue structure, comprise one can radial deformation pipe-shaped net rack, this network comprises Upstream section, stage casing and tract, surround a plurality of deformables unit between each netting twine of network, forming a plurality of curved lines at the two ends of network turns, on network, be provided with a plurality of closed line eyes, a plurality of flexibly jointed chain rings and a plurality of radiopaque marker, inboard in the network stage casing is connected with valve leaflet, inboard and/or lateral surface at the network Upstream section are coated with diaphragm seal, be characterized in, described network comprises the internal layer stake body of a tubular or tubular band radial protrusion structure, be connected with at least one in the outside of internal layer stake body and surround the tongue structure that forms by netting twine, outer tongue structure is preferably three, three outer tongue structures along the internal layer stake body radially evenly corner distribute, each tongue structure and internal layer stake body link to each other with the intersection in stage casing at tract or tract and form fixed edge, and begin the intersection formation free edge that section upstream extends to Upstream section and stage casing from fixed edge; Described valve leaflet is three, and three valve leaflet are distributed with 120 degree corners.
Described outer tongue structure and internal layer radial protrusion structure be axially and radially corresponding, and be arranged on the same anglec of rotation.
Described valve leaflet and tongue structure be axially and radially corresponding, and be arranged on same axial level and radially on the anglec of rotation.
A kind of weaving method of the support with tongue structure is: setting up the internal mold of a tubular or tubular band radial protrusion structure, is litzendraht wire with the elastic metallic wire rod, and the braiding main points are as follows:
A, get litzendraht wire from downstream port near support, outline spiral winding along internal mold is advanced, behind the support upstream port, turn to symmetric rightabout to advance again along the outline spiral winding of internal mold, repeat all to set up with this, be woven into the internal layer stake body of a tubular or tubular band radial protrusion structure up to all deformable unit;
B, begin to repeat braiding by same litzendraht wire from the litzendraht wire starting point of the downstream port of the internal layer stake body that woven, be equivalent to behind the about 60 degree angles of support when being woven into, allow litzendraht wire break away from the internal layer stake body, turn to symmetric rightabout to enter the internal layer stake body behind tongue structure of protruding coiled again and repeat braiding, be equivalent to behind about 1/3rd circumference of support when being woven into, allow litzendraht wire break away from the internal layer stake body again, turn to symmetric rightabout to enter the internal layer stake body behind tongue structure of protruding coiled again and repeat braiding, until being woven into three outer tongue structures, the final stage litzendraht wire enters the internal layer stake body and repeats to be woven into downstream port near support again;
C, when the woven outer layer tongue structure, the control litzendraht wire is from going out a little of stretching out of internal layer stake body and enter the advancing a little on the same sagittal plane of internal layer stake body of internal layer stake body, and control out a little and the distance between advancing a little is equivalent to change about 1/3rd circumference around support, the free edge of control tongue structure is positioned at the Upstream section of internal layer stake body and the intersection in stage casing;
D, be positioned at deformable unit number on the same sagittal plane of internal layer stake body and be woven into 3 multiple;
The different line segments of E, litzendraht wire constitute cross-point up and down when crossing, same line segment is opposite in the upper-lower position relation at its adjacent cross-point place, can slide mutually between two line segments on the same cross-point;
F, when braiding internal layer stake body, the deformable unit of being enclosed by the different line segments of litzendraht wire is a tetragon, litzendraht wire constitutes curved line and turns when the upstream port of support and downstream port turn to;
G, when braiding internal layer stake body, as required at the two ends of support or a certain cross-point at other position or flex point place litzendraht wire gone to few 360 degree angles constitute closed line eye;
H, when braiding internal layer stake body, on the litzendraht wire of the different parts of support, be with radiopaque marker as required, as on the two-wire section of two-wire section or closed line eye, being with the radiopaque marker ring.
Described will putting among the B, after litzendraht wire stretched out from the internal layer stake body, again around a semi-ring, the radian of the collar was suitable with the radian of semi-ring behind the collar of one at least 360 degree in all right elder generation, and the part of the collar and semi-ring are formed tongue structure jointly.
The described collar can be for breaking away from the full free state of internal layer stake body, and the part that also it can be positioned at internal layer stake body tract is woven into the internal layer stake body.
Described will putting among the B, litzendraht wire can also constitute closed line eye around at least 360 degree angles on its arc top when tongue structure of coiled, be with the radiopaque marker ring on the two-wire section of closed line eye.
Described will putting among the G, closed line eye can be woven into internal layer stake body or outer tongue structure on same outline curved surface, also can be woven into perpendicular or become arbitrarily angled with internal layer stake body or outer tongue structure.
Described tongue structure can also be formed by the braid different with the internal layer stake body.
The stent valve of band tongue structure of the present invention makes it compared with prior art owing to adopted above-mentioned technical scheme, has following advantage and good effect:
1, shape, 26S Proteasome Structure and Function are more optimized.
2, deformable support both can cooperate with biovalve also and can cooperate with synthetic valve.
3, increase the intensity and the life-span of synthetic valve, do not needed anticoagulant, be expected to replace biovalve.
But 4, stent valve radial compression is accurately carried under intervention device helps and is put in place, expansion then.
5, the stent valve after expansion discharges is in the radial and axial blood vessel wall shape that meets.
6, the stent valve of band tongue structure axially and direction of rotation can accurately locate and fix.
Description of drawings
Fig. 1 is the three-dimensional perspective of stent valve one embodiment of band tongue structure of the present invention;
Fig. 2 be support shown in Fig. 1 expanded view;
Fig. 3 is the vertical view of Fig. 1;
Fig. 4 is the three-dimensional perspective of the another embodiment of stent valve of band tongue structure of the present invention.
The specific embodiment
Referring to Fig. 1, Fig. 4, cooperation is referring to Fig. 2, Fig. 3, the stent valve of band tongue structure of the present invention comprises internal layer stake body 1, at least one outer tongue structure 2 (being preferably three), valve leaflet 3, diaphragm seal 4, flexibly jointed chain ring 5 and the radiopaque marker 6 of tubular (as shown in Figure 1) or tubular band radial protrusion structure (as shown in Figure 4).Internal layer stake body 1 is formed by elastic metallic wire rod 101 braiding, be one can be between expansion state and compressive state the extrusome of radial deformation, this internal layer stake body 1 can be according to be divided into Upstream section 11, stage casing 12 and tract 13 at endovascular blood flow direction.Surround a plurality of deformables unit 14 between internal layer stake body 1 each netting twine 101, form a plurality of curved lines at the two ends of network and turn 15, on network, also form a plurality of closed line eyes 16.When outer tongue structure 2 was three, three outer tongue structures 2 were connected the outside of internal layer stake body 1 and distribute with about 120 degree corners, surrounded by same or different netting twines to form.Each tongue structure 2 and internal layer stake body 1 link to each other with the intersection in stage casing at tract or tract and form fixed edge, and begin the intersection formation free edge that section upstream extends to Upstream section and stage casing from fixed edge.Tongue structure 2 is used to enter in the nature lobe leaf cup.When internal layer stake body 1 is subjected to radial compression, tongue structure 2 can be simultaneously by radial compression near internal layer stake body 1, after removing the compression restrained force, tongue structure 2 can be expanded away from internal layer stake body 1 flare port openings upstream.Valve leaflet 3 among the present invention is three, and three valve leaflet 3 are about 120 degree corners and distribute the inboard that is connected internal layer stake body 1 stage casing 12, and valve leaflet 3 can be made of biomaterial, also can be made of synthetic material.Synthetic material can be an elastomer, as silica gel or polyurethane.A bar reinforcing fibre 7 is at the most arranged in the synthetic material valve leaflet, and two different lobe leaves that 7 of this reinforcing fibres terminate in same valve leaflet are united a little or are united line, are connected on the support.Diaphragm seal 4 covers the inboard and/or the lateral surface of upstream section 11, and this Upstream section diaphragm seal 3 can guarantee that blood can not leak with the limit from stent valve.Diaphragm seal 4 can be biomembrane or synthetic film, and biomembrane can be in support inboard, the outside, or the interior outside exists simultaneously; Synthetic diaphragm seal can be elastomer such as silica gel, in the middle of support is wrapped in.A plurality of flexibly jointed chain rings 5 and a plurality of radiopaque marker 6 are separately positioned on the different parts of network.
The weaving method of the support of band tongue structure of the present invention is: the internal mold of at first setting up a tubular or tubular band radial protrusion structure, be that litzendraht wire weaves around the outline of internal mold with the elastic metallic wire rod then, the braiding main points can be described as follows in conjunction with Fig. 1, Fig. 2:
Get litzendraht wire 101 from certain a bit for example 102 beginning Fig. 2 near the support downstream port, outline spiral winding along internal mold is advanced, behind the internal mold port that is equivalent to the support upstream port, turn to symmetric rightabout to advance again along the outline spiral winding of internal mold, repeat all to set up with this, be woven into the internal layer stake body of a tubular or tubular band radial protrusion structure up to all deformable unit 14.When braiding internal layer stake body, the different line segments of litzendraht wire constitute cross-point 103,103 ' up and down when crossing, and the upper-lower position of same line segment at its adjacent cross-point place concern on the contrary, and for example shown in Figure 1 103 and 103 '.Between two line segments on the same cross-point, can slide mutually.The deformable unit 14 of being enclosed by the different line segments of litzendraht wire 101 is generally tetragon, and litzendraht wire constitutes curved line and turns 15 when the upstream port of support and downstream port turn to, so the deformable unit 14 at two ends is not the tetragon of standard.Can be as required during braiding at the two ends of support or a certain cross-point at other position or flex point place litzendraht wire gone to few 360 degree angles constitute closed line eye 16, closed line eye 16 can be woven in the support two ends, also can be woven between the two.One or more closed line eyes 16 can be arranged on each section line.Closed line eye 16 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can with put up arbitrarily angled.The curved line at support two ends turns 15, and closed line eye 16 can be in same level, also can be at varying level.
After having woven internal layer stake body 1, can begin to repeat braiding from the litzendraht wire starting point (for example 102 Fig. 2) of the downstream port of the internal layer stake body that woven by same litzendraht wire or different litzendraht wire, be equivalent to behind the about 60 degree angles of support (for example arriving 104 among Fig. 2) when being woven into, allow litzendraht wire break away from the internal layer stake body that has woven, turn to symmetric rightabout to enter the internal layer stake body behind tongue structure 2 of protruding coiled again and repeat braiding (for example from Fig. 2 105 enter), be equivalent to behind the about 120 degree angles of support when being woven into, the internal layer stake body that allows litzendraht wire break away from again to have woven (for example from Fig. 2 106 come out), turn to symmetric rightabout to enter the internal layer stake body behind another tongue structure 2 of protruding coiled again and repeat braiding (for example from Fig. 2 104 enter), until the outer tongue structure that is woven into three uniform distributions, the final stage litzendraht wire enters the internal layer stake body and repeats to be woven into downstream port (for example 107 among Fig. 2) near support again.When the woven outer layer tongue structure, control litzendraht wire from going out a little of stretching out of internal layer stake body with enter the advancing a little on the same sagittal plane of internal layer stake body of internal layer stake body, and control out a little and the distance between advancing a little is equivalent to change about 120 degree angles around support, the free edge of control tongue structure is positioned at the Upstream section of internal layer stake body and the intersection in stage casing.Among the present invention the deformable unit number on the internal layer stake body 1 same sagittal plane is woven into three multiple, helps the radially uniform distribution along the internal layer stake body when braiding of three tongue structures.Deformable unit number on the internal layer stake body shown in Figure 21 same sagittal plane is 15, be 3 multiple, like this, with regard to each tongue structure of may command go out a little and advance a little between distance be 5 deformable unit, being equivalent to changes 1/3rd circumference around support, and three tongue structures can uniform distribution.
When woven outer layer tongue structure 2, after litzendraht wire 101 stretches out from internal layer stake body 1, again around a semi-ring, the radian of the collar is suitable with the radian of semi-ring behind the collar 108 of one at least 360 degree in all right elder generation, and the part of the collar and semi-ring are formed tongue structure jointly.This collar 108 can be for breaking away from the full free state of internal layer stake body, and the part that also it can be positioned at internal layer stake body tract is woven into the internal layer stake body, as shown in Figure 2.
When woven outer layer tongue structure 2, the arc top lays out a small circle and forms closed line eye at its upstream end.Do not show this structure in the present embodiment.
Support of the present invention is in when braiding, also can be as required puts the different parts that radiopaque marker 6 is woven in support at the different line segments of litzendraht wire.The downstream of support is established an opacity point-like sign at least.The upstream extremity of support or Upstream section and stage casing intersection are established an opacity point-like sign at least, and the position of these signs is near the cup end of valve leaflet.
In sum, the weaving method of the stent valve of band tongue structure of the present invention and support thereof has following characteristics and advantage:
1, entire bracket is made of 101 braidings of elasticity litzendraht wire
The support that single line constitutes, globality is strong, and is more solid on the mechanics, and do not need to weld between each line.The welding or overlapping that can link to each other of single line starting point and terminal point.All 12 at litzendraht wire two of single line support in support tract 13 and stage casing.Two statures can upstream be held or downstream towards a direction.Single elasticity litzendraht wire 101 can the coiled curved line turns 15 and closed line eye 16.Closed line eye 16 can with support on same outline curved surface or on the tangent plane, also can with the perpendicular plane of support on (on the diametric plane) inwardly or outwards, also can be between these two.The deformable unit number that is positioned at same sagittal plane in the internal layer stake body 1 of the present invention's braiding is three multiple, and this helps three valve leaflet and three tongue structure uniform distribution.Slip on the cross-point between the adjacent segment litzendraht wire has guaranteed that support and tongue structure can radial compression, radial dilatation.
2, internal layer stake body 1 is provided with radiopaque marker
Radiopaque marker can be positioned at the upstream extremity of stent valve, downstream and valve leaflet binding site.
3, support 1 is provided with outer tongue structure 2
Outer tongue structure 2 blow-by films can allow blood pass through.Support backguy specific on tongue structure 2 and the apparatus for delivering cooperates, and can expand separately prior to stake body.The tongue structure 2 of expansion has location and fixation.The uniting a little to unite a little of tongue structure 2 definite rotation relationship can be arranged, as on same Plane of rotation with the lobe leaf.
4, be provided with reinforcing fibre 7 in the valve leaflet 3
Reinforcing fibre 7 has directional selectivity ground to improve the intensity of elastic synthesis material valve leaflet 3, reduces the probability that it is torn.Reinforcing fibre 7 is reinforced synthetic valve leaflet 3 annulars, does not hinder the valve leaflet switch; Synthetic valve leaflet 3 free edge strengthenings prevent that it from tearing; The line reinforcing is united a little and united to synthetic valve leaflet 3 with internal layer stake body 1 interconnecting part, makes interconnecting part become solid, is not torn; Make interconnecting part become slick and sly, reduce thrombosis.
5, the curved line on the internal layer stake body 1 turn 15 and closed line eye 16 help increasing radical elasticity, reduce material deformation; Reinforcing fibre 7 in the synthetic film of elasticity can be fixed on curved line and turn 15 and above the closed line eye 16; Closed line eye 16 can also the secure valve leaf unite a little, if closed line eye 16 turn 90 degrees angle and vertical with tangent plane to the inside, it moves in can making and uniting a little, valve leaflet tension force descends; Curved line turn 15 and closed line eye 16 be used for cooperating with apparatus for delivering, stent valve is temporary fixed, be compressed on the interior pipe of apparatus for delivering.The support backguy is as passing from closed line eye, it will be can slippage and move.