CN101172059B - Bracket valve with internal layer ligule structure and method for knitting bracket - Google Patents

Bracket valve with internal layer ligule structure and method for knitting bracket Download PDF

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Publication number
CN101172059B
CN101172059B CN 200610117809 CN200610117809A CN101172059B CN 101172059 B CN101172059 B CN 101172059B CN 200610117809 CN200610117809 CN 200610117809 CN 200610117809 A CN200610117809 A CN 200610117809A CN 101172059 B CN101172059 B CN 101172059B
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China
Prior art keywords
tongue
free
internal layer
rack body
tip
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CN 200610117809
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Chinese (zh)
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CN101172059A (en
Inventor
温宁
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Beijing Bai Ren medical Polytron Technologies Inc
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温宁
金磊
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Priority to CN 200610117809 priority Critical patent/CN101172059B/en
Priority to PCT/CN2007/003016 priority patent/WO2008052421A1/en
Publication of CN101172059A publication Critical patent/CN101172059A/en
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Publication of CN101172059B publication Critical patent/CN101172059B/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-shaped

Abstract

The invention relates to a bracket valve provided with an inner layer lingulate structure. The bracket valve comprises a pipe shaped reticular bracket main body with radial deformation function, a valve leaf, an overlay film, and also an inner layer lingulate structure connected on the inner side of the bracket main body. A bracket with the inner layer lingulate structure is formed by the inner layer lingulate structure and the bracket main body, the inner layer lingulate structure comprises at least an inner dissociative lingua which can move to the inner side of the bracket, the connection edge of the valve leaf and the overlap film is formed by the inner dissociative lingua, the valve leaf and the overlap film are connected with the inner dissociative lingua, or connected with the bracket main body through the inner dissociative lingua. The braiding method of the braiding bracket with the inner layer lingulate structure comprises a first braiding and a second braiding. Because the inner layer ingulate structure is arranged on the inner side of the bracket with the radial deformation function, the valve leaf is fixed through the inner dissociative lingua without being directly fixed on the bracket main body, the problems that the opening and closing movement position is directly arranged on the saturation part of the valve leaf and the bracket, and no stress is concentrated during the radial compression of the bracket valve and the opening or closing of the valve leaf when the biologic valve leaf is opening or closing are avoided, the wearing is reduced, and the servicing life is prolonged.

Description

The stent valve of band internal layer tongue structure and the weaving method of support thereof
Technical field
The present invention relates to a kind of succedaneum of tissue, relate in particular to a kind of with the stent valve of internal layer 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.There is left and right sides coronary ostium in the aortic valve downstream.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.
But, application number showed the stent valve of a kind of radial compression and radial dilatation but being the Chinese patent of CN200510110144.3 and CN200510110145.8.Support can be the single line braided support, also can be tubing cutting support.Lobe leaf and overlay film can be synthetic lobe leaf and synthetic overlay film, also can be bioprosthetic valve leaf and biological overlay film.But fixedly be on support, to reach between synthetic lobe leaf and synthetic overlay film and the radial deformation support by the elasticity macromolecular material that constitutes lobe leaf and overlay film is directly moulding.Above-mentioned stent valve is compared with traditional operation type biovalve (as U.S. Pat 4084268, US4106129, US4340091) that can not radial compression, but solution well of the sutured problem between the synthetic lobe leaf of lamellar or lamellar bioprosthetic valve leaf or animal valve and the radial deformation support.Mainly there is following problem:
1, the junction point (commissure) that does not have clear and definite specific fixed position to supply with the synthetic lobe leaf of lamellar or bioprosthetic valve leaf or animal nature valve on braided support or the cutting support is sewed up mutually with connecting line.
2, synthesizing lobe leaf or bioprosthetic valve leaf or animal nature valve as lamellar is sewn directly on the cross-point and litzendraht wire of braided support by a series of stitch points, or on the beam (strut) of cutting support, stress concentration in lobe leaf switching process mesopetalum leaf suture site, can cause lobe leaf damage herein, the life-span reduces.
3, the lobe leaf of stent valve associating line be subjected to supporting structure to influence the side's of being generally pocket-shape rather than resemble the nature valve or the surgery valve be the circle pocket-shape.The lobe leaf cup of side's pocket-shape has the dead angle, can increase the thrombosis chance herein.
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 internal layer 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 the internal layer tongue structure, comprise one can radial deformation pipe-shaped net rack body and lobe leaf and overlay film, also comprise the internal layer tongue structure that is connected the rack body inboard, internal layer tongue structure and rack body constitute the support of band internal layer tongue structure jointly, the internal layer tongue structure contains at least one can be to the interior free tongue of support medial movement, interior free tongue constitutes the edge that is connected of lobe leaf and overlay film, described lobe leaf links to each other with interior free tongue with overlay film, or links to each other with rack body by interior free tongue.
Described pipe-shaped net rack body comprises that there are the drum type network of drum type structure or the radially protruding type network of stage casing band radial protrusion structure or outer tongue structure in straight pipe type network, stage casing; The support of preferred band radial protrusion structure, the stage casing of this support are provided with three outwards outstanding hemispheric radial protrusion structures.
Described pipe-shaped net rack body is formed by the elastic metal wire up and down weaving, is provided with a plurality of closed line eyes on rack body; Described internal layer tongue structure is woven in the inboard of rack body by elastic metal wire, constitutes the braided support of band internal layer tongue structure jointly with rack body; Free tongue contains at least one free the tip of the tongue in described, and has at least one free root of the tongue portion to link to each other the connection edge of free the tip of the tongue formation lobe leaf junction point with rack body.
Described pipe-shaped net rack body is formed by the elastic metal wire braiding; Described internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that the elastic metal wire that at least one such circulus is configured rack body is woven in stake body constitutes the composite construction support of band internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
Described pipe-shaped net rack body is a tubing cutting support; Described internal layer tongue structure is woven in the inboard that tubing cuts support by elastic metal wire, constitutes the composite construction support of being with the internal layer tongue structure jointly with tubing cutting support; Free tongue contains at least one free the tip of the tongue in described, and has at least one free root of the tongue portion to link to each other the connection edge of free the tip of the tongue formation lobe leaf junction point with rack body.
Described pipe-shaped net rack body and internal layer tongue structure are formed by the elastic metal wire braiding respectively; Be with knitting sleeve pipe on the interior free tongue of described pipe-shaped net rack body and internal layer tongue structure; Described internal layer tongue structure by the knitting sleeve pipe on the free tongue in being enclosed within be enclosed within knitting sleeve pipe on the rack body and be stitched together and constitute the composite construction support of band internal layer tongue structure; Free tongue contains at least one free the tip of the tongue in described, and the free the tip of the tongue constitutes the connection edge of lobe leaf junction point.
Described pipe-shaped net rack body is a tubing cutting support; Described internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that at least one such circulus is welded on tubing cutting support constitutes the composite construction support of being with the internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
Free tongue is provided with at least one closed line eye in described.
At least one closed line eye that free tongue passes on the rack body in described links to each other with rack body, and the same closed line eye on the rack body is passed by free tongue at least one.
Be with knitting sleeve pipe on the litzendraht wire of free tongue in the described formation, these knitting telescopic two ends are sewn on the cross point of rack body litzendraht wire or on the closed line eye, described lobe leaf and overlay film be respectively by linking to each other with interior free tongue with knitting telescopic stitching, and be sutured on the rack body.
Described internal layer tongue structure contains free tongue in three; Free tongue has a free the tip of the tongue towards downstream direction in each, has two roots to link to each other with the rack body Upstream section; The line that braid in adjacent two between the free root of the tongue portion also forms towards updrift side on rack body turns.
Described internal layer tongue structure contains free tongue in three; Free tongue has a free the tip of the tongue towards downstream direction in each, has two roots to link to each other with the rack body Upstream section; The line that braid in separately two between the free root of the tongue portion also forms towards downstream direction on rack body turns.
Described internal layer tongue structure contains free tongue in three; Free tongue respectively has two free thes tip of the tongue towards downstream direction in each, each free the tip of the tongue respectively has a root to link to each other with the rack body Upstream section, link to each other by a free semicircle camber line towards updrift side between two free thes tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; Free tongue respectively has a free the tip of the tongue to meet on same corner in adjacent two; The line that braid in adjacent two between the free root of the tongue portion also forms towards updrift side on rack body turns.
Described internal layer tongue structure has only free tongue in, be 360 degree corners, should four free thes tip of the tongue be arranged towards downstream direction by interior free tongue, first and the 4th free the tip of the tongue is on the same corner, link to each other by a free semicircle camber line towards updrift side between the adjacent free the tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; First respectively has a root to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue.
Described internal layer tongue structure comprises free tongue in two, respectively is 360 degree corners, and free tongue is positioned at the downstream of another free tongue in one of them; Free tongue respectively has four free thes tip of the tongue towards downstream direction in two, first and the 4th free the tip of the tongue is on the same corner, link to each other by a free semicircle camber line towards updrift side between the adjacent free the tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; First respectively has a root to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue, in two each free the tip of the tongue of free tongue and each free semicircle camber line one by one correspondence be arranged on the same anglec of rotation.
A kind of weaving method of the braided support with the internal layer tongue structure is once woven by single or many elastic metal wires and to form, and the interior free tongue of internal layer tongue structure directly is woven in the inboard of stake body.
A kind of weaving method of the braided support with the internal layer tongue structure may further comprise the steps:
A, be woven into support for the first time, and the interior free tongue of internal layer tongue structure be woven in the outside of stake body by single or many elastic metal wires;
B, will weave the heat treatment that good support carries out shape memory, the support shape memory will be got off;
C, take support after Overheating Treatment apart the internal layer tongue structure along the rightabout of braiding for the first time;
D, knocked-down internal layer tongue structure is carried out second time braiding, and the interior free tongue of internal layer tongue structure is woven in the inboard of stake body.
But the stent valve of band internal layer tongue structure of the present invention is owing to be provided with the internal layer tongue structure in the support inboard of radial deformation, support and fixed structure have been formed corresponding to biovalve junction point and connecting line, the lobe leaf is fixed by interior free tongue, rather than directly be fixed on the rack body, the movable position of the switch of lobe leaf is located immediately at the suture site of lobe leaf and support when having avoided bioprosthetic valve leaf switch:
Unstressed concentrating reduced wearing and tearing when 1, making lobe leaf switch, prolonged service life.
2, two lobe leaves are involutory better when valve is closed on the junction point.
3, make stent valve warp-wise when compression or axially when drawing, rachis reduces to tractive lobe relatively.
When 4, making the blood impact lobe leaf that backflows that it is closed, interior free tongue moves in lobe leaf junction point place elasticity, and lobe leaf junction point stress reduces relatively.
In addition, owing to adopt the secondary weaving method, the interior free tongue of internal layer tongue structure has the naturally straight warp bigger than stake body, can make the interior free tongue of internal layer tongue structure be close to the stake body inwall.
Owing on the litzendraht wire of internal layer tongue structure, put knitting sleeve pipe, by being sewn to, valve realizes being connected and fixed of valve and internal layer tongue structure on the knitting sleeve pipe, with technology formerly textile sheet is wrapped on the litzendraht wire, being stitched into tube along litzendraht wire then compares, this the coaxial method that is enclosed within on the litzendraht wire of knitting sleeve pipe has been simplified technology, reduce volume, increased intensity and reliability.The elasticity litzendraht wire can also reduce thrombosis after wrapping terylene materials such as (Dacron), reduces the friction between metal knitted line and the biomaterial, makes things convenient for fixing between biomaterial and the elasticity litzendraht wire.
Description of drawings
Fig. 1 is the support plane outspread drawing (seeing from outside to inside) of first embodiment of the invention;
Fig. 2 is a stent valve plane outspread drawing (seeing from outside to inside) embodiment illustrated in fig. 1;
Fig. 3 is a stereochemical structure perspective cut-away schematic view embodiment illustrated in fig. 1;
Fig. 4 is the support plane outspread drawing (seeing from outside to inside) of second embodiment of the invention;
Fig. 5 is a stent valve plane outspread drawing (seeing from outside to inside) embodiment illustrated in fig. 4;
Fig. 6 is a stereochemical structure perspective cut-away schematic view embodiment illustrated in fig. 4;
Fig. 7 is the support plane outspread drawing (seeing from outside to inside) of third embodiment of the invention;
Fig. 8 is a stent valve plane outspread drawing (seeing from outside to inside) embodiment illustrated in fig. 7;
Fig. 9 is a stereochemical structure perspective cut-away schematic view embodiment illustrated in fig. 7;
Figure 10 is the support plane outspread drawing (seeing from outside to inside) of fourth embodiment of the invention;
Figure 11 is a stent valve plane outspread drawing (seeing from outside to inside) embodiment illustrated in fig. 10;
Figure 12 is a stereochemical structure perspective cut-away schematic view embodiment illustrated in fig. 10;
Figure 13 is the support plane outspread drawing (seeing from outside to inside) of fifth embodiment of the invention;
Figure 14 is a stent valve plane outspread drawing (seeing from outside to inside) embodiment illustrated in fig. 13;
Figure 15 is a stereochemical structure perspective cut-away schematic view embodiment illustrated in fig. 13;
Figure 16 is the structural representation of a kind of free the tip of the tongue among the present invention;
Figure 17 is the structural representation of the free the tip of the tongue of the another kind among the present invention;
Figure 18 is the structural representation of a kind of free the tip of the tongue among the present invention and the combination of free semi arch;
Figure 19 is a kind of free the tip of the tongue among the present invention and the annexation sketch map of support;
Figure 20 is the annexation sketch map of the free the tip of the tongue of the another kind among the present invention and support;
Figure 21 is the annexation sketch map of a kind of free the tip of the tongue among the present invention and combination of free semi arch and support.
Plan structure sketch map when Figure 22 adopts the support of being with radial protrusion structure for the rack body among the present invention (from downstream toward upstream extremity).
The specific embodiment
Referring to Fig. 1, cooperate referring to all the other each figure, the stent valve of band internal layer tongue structure of the present invention, comprise one can radial deformation pipe-shaped net rack body 1, lobe leaf 2, overlay film 3 and internal layer tongue structure 4.Internal layer tongue structure 4 is connected the inboard of rack body 1, constitutes the support of being with the internal layer tongue structure jointly with rack body.Internal layer tongue structure 4 contains at least one can be to the interior free tongue of support medial movement, and interior free tongue constitutes the edge that is connected of lobe leaf 2 and overlay film 3, and lobe leaf 2 links to each other with interior free tongue with overlay film 3, or links to each other with rack body by interior free tongue.
Pipe-shaped net rack body among the present invention can be that straight pipe type network, stage casing have the drum type network of drum type structure or the radially protruding type network of stage casing band radial protrusion structure or outer tongue structure.
The support of the band internal layer tongue structure among the present invention can have following several version;
1, the pipe-shaped net rack body is formed by the elastic metal wire up and down weaving, is provided with a plurality of closed line eyes on rack body; The internal layer tongue structure is woven in the inboard of rack body by elastic metal wire, constitutes the braided support of band internal layer tongue structure jointly with rack body; In free tongue contain at least one free the tip of the tongue, and have at least one free root of the tongue portion to link to each other the connection edge of free the tip of the tongue formation lobe leaf junction point with rack body.
2, the pipe-shaped net rack body is formed by the elastic metal wire braiding; The internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that the elastic metal wire that at least one such circulus is configured rack body is woven in stake body constitutes the composite construction support of band internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
3, the pipe-shaped net rack body is a tubing cutting support; The internal layer tongue structure is woven in the inboard that tubing cuts support by elastic metal wire, constitutes the composite construction support of being with the internal layer tongue structure jointly with tubing cutting support; In free tongue contain at least one free the tip of the tongue, and have at least one free root of the tongue portion to link to each other with rack body; The free the tip of the tongue constitutes the connection edge of lobe leaf junction point.
4, pipe-shaped net rack body and internal layer tongue structure are formed by the elastic metal wire braiding respectively; Be with knitting sleeve pipe on the interior free tongue of pipe-shaped net rack body and internal layer tongue structure, the internal layer tongue structure by the knitting sleeve pipe on the free tongue in being enclosed within be enclosed within knitting sleeve pipe on the rack body and be stitched together and constitute the composite construction support of band internal layer tongue structure; Interior free tongue contains at least one free the tip of the tongue; The free the tip of the tongue constitutes the connection edge of lobe leaf junction point.
5, the pipe-shaped net rack body is a tubing cutting support; The internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that at least one such circulus is welded on tubing cutting support constitutes the composite construction support of being with the internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
Here introduce first kind of version, promptly with the braided support of internal layer tongue structure.See also Fig. 1, cooperation is referring to Fig. 4, Fig. 7, Figure 10, Figure 13 and Figure 22, pipe-shaped net rack 1 is formed by 101 braidings of elastic metallic wire rod, be one can be between expansion state and compressive state the extrusome of radial deformation, this network 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 each netting twine 101 of network, 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.Lobe leaf 2 is arranged on 12 inboards, stage casing of rack body 1, and overlay film 3 is arranged on the Upstream section 11 of rack body.Internal layer tongue structure 4 can be formed by same elastic metal wire braiding of braided support body, also can form by another different root elastic metal wire braidings, it contains at least one can be to the interior free tongue of support medial movement, can be provided with at least one closed line eye on the free tongue in this.
Fig. 1, Fig. 2, Fig. 3 are the structural representations of first embodiment of the stent valve of band internal layer tongue structure of the present invention.In the present embodiment, internal layer tongue structure 4 contains in three and to be 120 degree corners between the free tongue in 41,42,43, three in the free tongue and to distribute; Free tongue respectively has a free the tip of the tongue 411,421,431 towards downstream direction in each, and two roots 412,412 ', 422,422 ' are respectively arranged, and 432,432 ' links to each other with the rack body Upstream section; The line that braid in adjacent two between the free root of the tongue portion also forms towards updrift side on rack body turns 413,423,433.
Fig. 4, Fig. 5, Fig. 6 are the structural representations of second embodiment of the stent valve of band internal layer tongue structure of the present invention.In the present embodiment, internal layer tongue structure 4 contains in three and to be 120 degree corners between the free tongue in 41,42,43, three in the free tongue and to distribute; Free tongue respectively has a free the tip of the tongue 411,421,431 towards downstream direction in each, respectively has two roots 412,412 ', 422,422 ', 432,432 ' to link to each other with the rack body Upstream section; Between free tongue in separately two (for example 41, the 43) root braid of (for example between 412 and 432 ') on rack body and formation turn 413,423,433 towards the line of downstream direction.
Fig. 7, Fig. 8, Fig. 9 are the structural representations of the 3rd embodiment of the stent valve of band internal layer tongue structure of the present invention.In the present embodiment, internal layer tongue structure 4 contains in three and to be 120 degree corners between the free tongue in 41,42,43, three in the free tongue and to distribute; Free tongue respectively has two free thes tip of the tongue 411,411 ', 421,421 ', 431,431 ' towards downstream direction in each, respectively has two roots 412,412 ', 422,422 ', 432,432 ' to link to each other with the rack body Upstream section; Be 120 degree corners in same between two free thes tip of the tongue of free tongue and pass through a free semicircle camber line 414,424,434 and link to each other towards updrift side; Free tongue respectively has a free the tip of the tongue to meet on same corner (for example 411 ' and 421 are positioned at same corner) in adjacent two, between free tongue in adjacent two (for example 41, the 43) root braid of (for example 412 ' and 432) on rack body also formation turn 413,423,433 towards the line of updrift side.
Figure 10, Figure 11, Figure 12 are the structural representations of the 4th embodiment of the stent valve of band internal layer tongue structure of the present invention.In the present embodiment, internal layer tongue structure 4 has only free tongue 44 in, be 360 degree corners, should in free tongue 44 four free thes tip of the tongue 441,442,443,444 are arranged towards downstream direction, first free the tip of the tongue 441 and the 4th the free the tip of the tongue 444 are on the same corner, 120 degree corners are arranged between the adjacent free the tip of the tongue, and continuous by a free semicircle camber line 445,446,447 towards updrift side, first free the tip of the tongue 441 respectively has a root 4411,4441 to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue 444.
Figure 13, Figure 14, Figure 15 are the structural representations of the 5th embodiment of the stent valve of band internal layer tongue structure of the present invention.In the present embodiment, internal layer tongue structure 4 comprises free tongue 45,46 in two, respectively is 360 degree corners, and free tongue 46 is positioned at the downstream of another free tongue 45 in one of them.In free tongue 45 four free thes tip of the tongue 451,452,453,454 are arranged towards downstream direction, wherein first free the tip of the tongue 451 and the 4th the free the tip of the tongue 454 are on the same corner, 120 degree corners are arranged between the adjacent free the tip of the tongue, and continuous by a free semicircle camber line 455,456,457 towards updrift side, wherein first free the tip of the tongue 451 respectively has a root 4511,4541 to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue 454.In free tongue 46 four free thes tip of the tongue 461,462,463,464 are arranged towards downstream direction, wherein first free the tip of the tongue 461 and the 4th the free the tip of the tongue 464 are on the same corner, 120 degree corners are arranged between the adjacent free the tip of the tongue, and it is continuous by a free semicircle camber line 465,466,467 towards updrift side, wherein first free the tip of the tongue 461 respectively has a root 4611,4641 to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue 464, wherein 4611 with the root 4541 of interior free tongue 45 are same section litzendraht wires.In two each free the tip of the tongue of free tongue 45,46 and each free semicircle camber line one by one correspondence be arranged on the same anglec of rotation.
The foregoing description is several typical embodiment of the present invention, and the stent valve of band internal layer tongue structure of the present invention is not limited to the foregoing description.In the above-described embodiments, as Figure 16, Figure 17, Figure 18, Figure 19, Figure 20, shown in Figure 21, can be provided with at least one closed line eye 16 on the free the tip of the tongue of free tongue in each.Also can be provided with at least one closed line eye 16 (Figure 18, Figure 21) on the free semicircle camber line of free tongue in each.The free the tip of the tongue can also be designed to as Figure 19, Cyclotron structure 17 (snakelike) or 18 (Long Circles) shown in Figure 20, and the interior free tongue of this band Cyclotron structure can pass the closed line eye 16 on one or more stake bodies.Length variations when Cyclotron structure litzendraht wire can compensate support radial compression and expansion.The one or more closed line eye that free tongue can pass on the rack body in each links to each other with rack body, and the closed line eye on the same rack body also can be passed by free tongue in one or more.
Can be with knitting sleeve pipe 5 (referring to Fig. 9, Figure 12, Figure 15) on the litzendraht wire of free tongue in constituting, this knitting sleeve pipe can be made by knitting (knitting) or tatting (Weaving) mode with terylene textile materials such as (Dacron).These knitting telescopic two ends are sewn on the cross point of rack body litzendraht wire or on the closed line eye, to prevent its slip.
The support of the band internal layer tongue structure among the present invention can adopt single or many (preferably adopting single) elastic metal wires once weave and form, and the interior free tongue of internal layer tongue structure directly is woven in the inboard of stake body.Also can adopt the secondary weaving method, promptly at first use single or many (preferably adopting single) elastic metal wires are woven into support for the first time, and the interior free tongue of internal layer tongue structure is woven in the outside of stake body; Then will weave good support and carry out the heat treatment of shape memory, the support shape memory will be got off; Take the support after Overheating Treatment apart the internal layer tongue structure along the rightabout of braiding for the first time again; At last knocked-down internal layer tongue structure is carried out the braiding second time, and the interior free tongue of internal layer tongue structure is woven in the inboard of stake body.The natural diameter of the interior free tongue that the secondary braiding constitutes makes it withstand on the stake body inboard greater than the internal diameter of stake body, helps valve is clipped between interior free tongue and the stake body.
Preferably with the support of radial protrusion structure, the stage casing of this support is provided with three outwards outstanding hemispheric radial protrusion structures to rack body among the present invention, and three radial protrusion structures are 120 degree corners and distribute.When rack body 1 adopted the support of band radial protrusion structure, it saw plan structure in the past as shown in figure 22 from downstream toward upstream extremity.The free the tip of the tongue 7 of each of internal layer tongue structure 4 is arranged on the inboard of the joint portion of the outstanding structure 6 of each adjacent radial.120 degree corners are arranged between the adjacent free the tip of the tongue 7, and link to each other by a free semicircle camber line 445,446,447 towards updrift side, free semicircle camber line 445,446,447 is parallel with the semi-moon shaped upstream periphery of radial protrusion structure 6.
Lobe leaf and overlay film among the present invention can adopt:
1, three symmetric lobe leaf lamination patch, promptly constitute by same lamellar biomaterial (as the animal pericardium), have three lobe leaf lamination patch that are symmetrically distributed by circumference (shown in Figure 14 promptly is to adopt this scheme) on the stent valve at same circumference angle epivalve leaf and overlay film.
2, the lobe leaf lamination patch of an integral body will be replaced by the full wafer that the girth summation equates by three lobe leaf lamination patch that circumference is symmetrically distributed; Have only the longitudinal seam zygonema will be like this with cylinder of the involutory formation stitched together of two sutural margins of a slice (Fig. 2, shown in Figure 5 promptly is this scheme that adopts).
3, three symmetric lobe blades and three symmetric lamination patch are connected with three flaky material lobe leaves and other three flaky material overlay films on the stent valve.(Fig. 8, shown in Figure 11 promptly be this scheme that adopts).
4, animal nature valve is as porcine aorta valve (comprising that lobe leaf and its blood vessel wall constitute overlay film).
The position relation of lobe leaf among the present invention and overlay film and internal layer tongue structure and rack body has following several:
1, when support has only one deck internal layer tongue structure, interior free tongue can be at the medial surface (upstream face) of lobe leaf overlay film; Also can be at the lateral surface (downstream face) of lobe leaf overlay film.
Interior free tongue is at the medial surface (upstream face) of lobe leaf overlay film, the overlay film of lobe leaf overlay film partly is clipped between rack body and the interior free tongue (as shown in Figure 5), whole in free tongue the overlay film of lobe leaf overlay film is partly withstood on unstressed concentrated rotation edge when constituting lobe leaf switch on the rack body medial surface.
Interior free tongue is at the lateral surface (downstream face) of lobe leaf, the free the tip of the tongue is united two adjacent lobe leaves a little at the lobe leaf and is clamped, make to draw close between lobe leaf and the lobe leaf and close, free semicircle camber line partly is clipped in the upstream overlay film of lobe leaf overlay film between rack body and the interior free tongue (as Fig. 8 in the extension of lobe leaf connecting line downstream, shown in Figure 11), whole in free tongue the overlay film of lobe leaf overlay film is partly withstood on unstressed concentrated rotation edge when constituting lobe leaf switch on the rack body medial surface.
2, when support has two layers or multilayer internal layer tongue structure, at least one free tongue the medial surface (upstream face) of lobe leaf overlay film or and at least one is at lateral surface (downstream face):
Internal layer tongue structure parallel more than two or two can arranged on the same anglec of rotation.The interior free tongue of at least one big radian (free semicircle camber line) is at the medial surface (lobe leaf upstream side) of lobe leaf lamination patch, and the overlay film of lobe leaf lamination patch partly is clipped between rack body and the interior free tongue.The interior free tongue of the less radian that at least one is parallel (free the tip of the tongue) is at the lateral surface (lobe leaf downstream side) of lobe leaf lamination patch, two adjacent lobe leaves united a little at the lobe leaf clamp, and makes to draw close between lobe leaf and the lobe leaf and closes (as shown in figure 14).
For example: three flaky material lobe leaves are arranged in the stake body inboard.The interior free tongue of internal layer tongue structure is positioned at lobe leaf lateral surface (lobe leaf downstream face).One of each of two adjacent lobe leaves is sewed up the terminal interior free the tip of the tongue that passes an internal layer tongue structure together, and is clamped by it.Lobe leaf sutural margin is walked around the free semicircle camber line of internal layer tongue structure, and is positioned at the downstream of lobe leaf associating line, local formation downstream overlay film (as Fig. 8, shown in Figure 11).
In the stake body inboard or the outside three flaky material upstream overlay films can be arranged.Two axial sutural margins of two adjacent upstream lamination patch are sewed up relatively.Knitting sleeve pipe that is with on the downstream edge of upstream lamination patch and the internal layer tongue structure and lobe leaf sutural margin three are stitched together.The upstream extremity of upstream lamination patch and support upstream extremity are stitched together.
Between free tongue and the lobe leaf overlay film stitching can be arranged among the present invention, also can not sew up.As will sewing up, trend towards directly not sewing up, do not have stitch points place stress concentration like this.Way is, puts knitting sleeve pipe 5 (seeing Fig. 9, Figure 12, Figure 15) on the elasticity litzendraht wire of interior free tongue, rotates the edge offside at the lobe leaf, sews up between upstream overlay film or lobe leaf downstream overlay film and the knitting sleeve pipe.Then, (a), do not link to each other with rack body; (b), lobe leaf overlay film is sewn on the rack body by knitting sleeve pipe; (c), lobe leaf overlay film is sewn on the outer tongue structure of stake body by knitting sleeve pipe.
Sew up mutually between vertical sutural margin of each adjacent petals leaf lamination patch, also can be sewn on the support simultaneously.
The upstream edge of lobe leaf lamination patch and support upstream extremity are sewed up.
Innovative point of the present invention is:
1, in the stake body inboard internal layer tongue structure is set, the internal layer tongue structure can exist simultaneously with outer tongue structure.Internal layer tongue structure and stake body can be formed by same single elasticity braid.Internal layer tongue structure and stake body and outer tongue structure can be formed by same single elasticity braid.The internal layer tongue structure is single braided support part of the whole.The free the tip of the tongue has certain centripetal direction freedom of movement, can reduce the stress on the lobe leaf junction point when lobe leaf switch.
2, in the stake body inboard of two-layer support or multilamellar support, the interior free tongue of internal layer tongue structure withstands on the stake body medial surface in unstressed concentrated mode with the upstream face of lobe leaf associating line and Upstream section overlay film or with downstream face.The interior free tongue of internal layer tongue structure also can be united the lobe leaf at lobe leaf downstream face and located two lobe leaves and clamp, and makes it be closed condition under no tension force situation.
3, on the production technology, single line or multi-thread support weave and after the heat treatment shape memory is shaped, can part or complete removal braiding.Some structure when weaving again, position as the free tongue of internal layer tongue structure can change, as changing to inboard (the straight warp of less restriction) from the stake body outside (than the straight warp of the Nature), the free tongue that makes the internal layer tongue structure withstands on the stake body inwall under self resilience force effect.Can add when weaving again and can not stand heat treated material, the valve of making as biomaterial, or add independently naturally directly through the bigger ring that three free thes tip of the tongue and three free semicircle camber lines are arranged.After the braiding of single line support complete removal, can wear from of single-braid when weaving again, can wear from two of single-braid.
4, can be with the knitting sleeve pipe that one or more bores cooperatively interact on single line or the multi-thread support litzendraht wire, and need not sew up.

Claims (17)

1. stent valve with the internal layer tongue structure, comprise one can radial deformation pipe-shaped net rack body and lobe leaf and overlay film, it is characterized in that: also comprise the internal layer tongue structure that is connected the rack body inboard, internal layer tongue structure and rack body constitute the support of band internal layer tongue structure jointly, the internal layer tongue structure contains at least one can be to the interior free tongue of support medial movement, interior free tongue constitutes the edge that is connected of lobe leaf and overlay film, described lobe leaf links to each other with interior free tongue with overlay film, or links to each other with rack body by interior free tongue.
2. the stent valve of band internal layer tongue structure as claimed in claim 1 is characterized in that: described pipe-shaped net rack body comprises that there are the drum type network of drum type structure or the radially protruding type network of stage casing band radial protrusion structure or outer tongue structure in straight pipe type network, stage casing; The stage casing of the support of wherein said band radial protrusion structure is provided with three outwards outstanding hemispheric radial protrusion structures.
3. the stent valve of band internal layer tongue structure as claimed in claim 1 or 2 is characterized in that: described pipe-shaped net rack body is formed by the elastic metal wire up and down weaving, is provided with a plurality of closed line eyes on rack body; Described internal layer tongue structure is woven in the inboard of rack body by elastic metal wire, constitutes the braided support of band internal layer tongue structure jointly with rack body; Free tongue contains at least one free the tip of the tongue in described, and has at least one free root of the tongue portion to link to each other the connection edge of free the tip of the tongue formation lobe leaf junction point with rack body.
4. the stent valve of band internal layer tongue structure as claimed in claim 1 or 2 is characterized in that: described pipe-shaped net rack body is formed by the elastic metal wire braiding; Described internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that the elastic metal wire that at least one such circulus is configured rack body is woven in stake body constitutes the composite construction support of band internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
5. the stent valve of band internal layer tongue structure as claimed in claim 1 or 2 is characterized in that: described pipe-shaped net rack body is a tubing cutting support; Described internal layer tongue structure is woven in the inboard that tubing cuts support by elastic metal wire, constitutes the composite construction support of being with the internal layer tongue structure jointly with tubing cutting support; Free tongue contains at least one free the tip of the tongue in described, and has at least one free root of the tongue portion to link to each other the connection edge of free the tip of the tongue formation lobe leaf junction point with rack body.
6. the stent valve of band internal layer tongue structure as claimed in claim 1 or 2 is characterized in that: described pipe-shaped net rack body and internal layer tongue structure are formed by the elastic metal wire braiding respectively; Be with knitting sleeve pipe on the interior free tongue of described pipe-shaped net rack body and internal layer tongue structure; Described internal layer tongue structure by the knitting sleeve pipe on the free tongue in being enclosed within be enclosed within knitting sleeve pipe on the rack body and be stitched together and constitute the composite construction support of band internal layer tongue structure; Free tongue contains at least one free the tip of the tongue in described, and the free the tip of the tongue constitutes the connection edge of lobe leaf junction point.
7. the stent valve of band internal layer tongue structure as claimed in claim 1 or 2 is characterized in that: described pipe-shaped net rack body is a tubing cutting support; Described internal layer tongue structure is the independently circulus that is formed or formed by sheet material cutting after strain by tubing cutting, and this circulus has three free thes tip of the tongue and three free semicircle camber lines; The inboard that at least one such circulus is welded on tubing cutting support constitutes the composite construction support of being with the internal layer tongue structure; The free the tip of the tongue in the circulus constitutes the connection edge of lobe leaf junction point, and free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line.
8. the stent valve of band internal layer tongue structure as claimed in claim 3 is characterized in that: free tongue is provided with at least one closed line eye in described.
9. the stent valve of band internal layer tongue structure as claimed in claim 3, it is characterized in that: at least one closed line eye that free tongue passes on the rack body in described links to each other with rack body, and the same closed line eye on the rack body is passed by free tongue at least one.
10. the stent valve of band internal layer tongue structure as claimed in claim 3, it is characterized in that: be with knitting sleeve pipe on the litzendraht wire of free tongue in the described formation, these knitting telescopic two ends are sewn on the cross point of rack body litzendraht wire or on the closed line eye, described lobe leaf and overlay film be respectively by linking to each other with interior free tongue with knitting telescopic stitching, and be sutured on the rack body.
11. the stent valve of band internal layer tongue structure as claimed in claim 3 is characterized in that: described internal layer tongue structure contains free tongue in three; Free tongue all has a free the tip of the tongue towards downstream direction in each, has two roots to link to each other with the rack body Upstream section simultaneously; The line that braid in adjacent two between the free root of the tongue portion also forms towards updrift side on rack body turns.
12. the stent valve of band internal layer tongue structure as claimed in claim 3 is characterized in that: described internal layer tongue structure contains free tongue in three; Free tongue all has a free the tip of the tongue towards downstream direction in each, has two roots to link to each other with the rack body Upstream section simultaneously; The line that braid in separately two between the free root of the tongue portion also forms towards downstream direction on rack body turns.
13. the stent valve of band internal layer tongue structure as claimed in claim 3 is characterized in that: described internal layer tongue structure contains free tongue in three; Free tongue respectively has two free thes tip of the tongue towards downstream direction in each, each free the tip of the tongue respectively has a root to link to each other with the rack body Upstream section, link to each other by a free semicircle camber line towards updrift side between two free thes tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; Free tongue respectively has a free the tip of the tongue to meet on same corner in adjacent two; The line that braid in adjacent two between the free root of the tongue portion also forms towards updrift side on rack body turns.
14. the stent valve of band internal layer tongue structure as claimed in claim 3, it is characterized in that: described internal layer tongue structure has only free tongue in, be 360 degree corners, should four free thes tip of the tongue be arranged towards downstream direction by interior free tongue, first and the 4th free the tip of the tongue is on the same corner, link to each other by a free semicircle camber line towards updrift side between the adjacent free the tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; First respectively has a root to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue.
15. the stent valve of band internal layer tongue structure as claimed in claim 3 is characterized in that: described internal layer tongue structure comprises free tongue in two, respectively is 360 degree corners, and free tongue is positioned at the downstream of another free tongue in one of them; Free tongue respectively has four free thes tip of the tongue towards downstream direction in two, first and the 4th free the tip of the tongue is on the same corner, link to each other by a free semicircle camber line towards updrift side between the adjacent free the tip of the tongue, this free semicircle camber line constitutes the connection edge of lobe leaf overlay film connecting line; First respectively has a root to link to each other with the rack body Upstream section with the 4th the free the tip of the tongue, in two each free the tip of the tongue of free tongue and each free semicircle camber line one by one correspondence be arranged on the same anglec of rotation.
16. the weaving method with the braided support of internal layer tongue structure is characterized in that: once woven by single or many elastic metal wires and to form, the interior free tongue of internal layer tongue structure directly is woven in the inboard of stake body.
17. the weaving method with the braided support of internal layer tongue structure is characterized in that, may further comprise the steps:
A, be woven into support for the first time, and the interior free tongue of internal layer tongue structure be woven in the outside of stake body by single or many elastic metal wires;
B, will weave the heat treatment that good support carries out shape memory, the support shape memory will be got off;
C, take support after Overheating Treatment apart the internal layer tongue structure along the rightabout of braiding for the first time;
D, knocked-down internal layer tongue structure is carried out second time braiding, and the interior free tongue of internal layer tongue structure is woven in the inboard of stake body.
CN 200610117809 2006-10-31 2006-10-31 Bracket valve with internal layer ligule structure and method for knitting bracket Active CN101172059B (en)

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PCT/CN2007/003016 WO2008052421A1 (en) 2006-10-31 2007-10-22 Stent valve with inner tongue structure and weaving method of the stent thereof

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