CN203736349U - Novel aorta valve stent - Google Patents
Novel aorta valve stent Download PDFInfo
- Publication number
- CN203736349U CN203736349U CN201320813283.2U CN201320813283U CN203736349U CN 203736349 U CN203736349 U CN 203736349U CN 201320813283 U CN201320813283 U CN 201320813283U CN 203736349 U CN203736349 U CN 203736349U
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- Prior art keywords
- sealing unit
- aortic valve
- valve stent
- fixture
- support
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- Expired - Lifetime
Links
- 210000000709 aorta Anatomy 0.000 title abstract description 5
- 238000007789 sealing Methods 0.000 claims abstract description 117
- 239000000463 material Substances 0.000 claims abstract description 19
- 239000002184 metal Substances 0.000 claims abstract description 11
- 210000001765 aortic valve Anatomy 0.000 claims description 48
- 238000009730 filament winding Methods 0.000 claims description 3
- 230000015572 biosynthetic process Effects 0.000 claims description 2
- 239000012528 membrane Substances 0.000 abstract 1
- 210000001519 tissue Anatomy 0.000 description 34
- 238000013461 design Methods 0.000 description 14
- 238000010586 diagram Methods 0.000 description 14
- 230000000694 effects Effects 0.000 description 13
- 238000000034 method Methods 0.000 description 7
- 238000007599 discharging Methods 0.000 description 5
- 238000005516 engineering process Methods 0.000 description 5
- 230000006870 function Effects 0.000 description 5
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 4
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 description 4
- 229910001000 nickel titanium Inorganic materials 0.000 description 4
- -1 polyethylene Polymers 0.000 description 4
- 239000011358 absorbing material Substances 0.000 description 3
- 229910045601 alloy Inorganic materials 0.000 description 3
- 239000000956 alloy Substances 0.000 description 3
- 238000013459 approach Methods 0.000 description 3
- 238000002513 implantation Methods 0.000 description 3
- 230000001788 irregular Effects 0.000 description 3
- 229950000845 politef Drugs 0.000 description 3
- 230000008569 process Effects 0.000 description 3
- 238000003466 welding Methods 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000004743 Polypropylene Substances 0.000 description 2
- 229920004933 Terylene® Polymers 0.000 description 2
- 230000036770 blood supply Effects 0.000 description 2
- 230000002308 calcification Effects 0.000 description 2
- 210000001105 femoral artery Anatomy 0.000 description 2
- 230000000004 hemodynamic effect Effects 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 238000012544 monitoring process Methods 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 239000005020 polyethylene terephthalate Substances 0.000 description 2
- 229920001155 polypropylene Polymers 0.000 description 2
- 230000001105 regulatory effect Effects 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 230000002792 vascular Effects 0.000 description 2
- 206010008190 Cerebrovascular accident Diseases 0.000 description 1
- 208000009525 Myocarditis Diseases 0.000 description 1
- 208000006011 Stroke Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 210000002376 aorta thoracic Anatomy 0.000 description 1
- 206010002906 aortic stenosis Diseases 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000007423 decrease Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000009432 framing Methods 0.000 description 1
- 210000003709 heart valve Anatomy 0.000 description 1
- 238000005213 imbibition Methods 0.000 description 1
- 239000007943 implant Substances 0.000 description 1
- 238000009413 insulation Methods 0.000 description 1
- 238000010030 laminating Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 210000003516 pericardium Anatomy 0.000 description 1
- 210000005259 peripheral blood Anatomy 0.000 description 1
- 239000011886 peripheral blood Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000004083 survival effect Effects 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 230000002861 ventricular Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart 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
- A61F2/2412—Heart 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
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0069—Sealing means
Abstract
The utility model provides a novel aorta valve stent (100), which comprises a stent body (110) and an artificial valve (104), wherein the stent body (110) is composed of multiple grid units (112); the artificial valve (104) is connected with the grid units (112); a sealing unit (106) is arranged on the outer side of the stent body (110); the sealing unit (106) is made of metal memory material and a membrane covers the sealing unit (106); in a natural state, the sealing unit (106) arches outwards in the axial direction of the stent body (110) and form a ring-shaped structure in the circumferential direction of the stent body (110); one end of the sealing unit (106) is a free end (116); the other end of the sealing unit (106) is fixed with the grid units (112) through fixing pieces (138) and is a fixed end (126); when the sealing unit (106) is compressed into a sheath, the free end (116) of the sealing unit (106) extends in the axial direction of the stent body (110).
Description
Technical field:
This utility model belongs to medical instruments field, is specifically related to a kind of novel aortic valve stent.
Background technology:
Through apex of the heart aortic valve implantation (TAAVI) be a kind of treat aortic stenosis, Wicresoft, without the technology of extracorporeal circulation.Operation process comprises the approach using the little otch in left front sidewall thoracic cavity as the direct forward direction implantation of left ventricular apex portion, with after through conduit implantable artificial aortic valve.Nearest clinical trial has confirmed the feasibility of TAAVI.In January, 2008, the Edwards Sapien valve that is applicable to TAAVI obtains the unified CE marking in Europe; Thereby by using this technology, multiple European medical centers have raked in increasing clinical experience.
At present, clinical effectiveness is told us, and compared with implanting with through femoral artery, the operation of TAAVI in ascending aorta and aortic arch is little, and apoplexy occurrence risk is low.The valve contrast locating of TAAVI is more accurate through femoral artery approach, implants so safer.Even if there is the most patient of serious peripheral blood vessel, also can complete this technology.However, perivalvular leakage still causes concern as common adverse events, and myocardial inflammation etc. greatly affected more after quality of life.Have to Continual Improvement technical scheme and carry out apparatus innovation of research staff, to improve patient's survival rate, improves patient's weather.
In patent US7445631, Sadra has disclosed a aortic valve braided support, and frame bottom laminating support grid fixing by macromolecule or the made shirt rim of pericardium material to alleviating perivalvular leakage, such design can be played certain anti-perivalvular leakage effect, but it is larger to load sheath pipe, thereby can limit its application.
In patent EP1980220, JenaValve proposes a aortic valve stent of carrying through the apex of the heart, and this patent has comparatively at large been described by clamping former calcification valve and reached the effect that reduces perivalvular leakage.However,, in the time that the gap of patient's calcification valve is originally irregular or do not close up, this design cannot improve perivalvular leakage situation; And the design of its folder lobe is also not suitable for aorta bilobed flap patient.Clinical effectiveness also shows that this design will cause patient's pressure gradient to improve, and affect the treatment.
A kind of ascending aorta inner cavity insulation support with the fixing capsule of filled-type is proposed in patent CN201120022195, the fixing capsule of filled-type is sewed up or is bonded with in its outside at overlay film straight tube support, water absorbing material is housed in capsule, it can imbibition in blood vessel, thereby play fixed support, prevent the effect of displacement.This water absorbing material also can be used to prevent in the scheme of perivalvular leakage, but its defect is the speed of uncontrollable water suction, once and these water absorbing material leak into outside capsule, can bring huge risk, jeopardize patient's life security.
Patent WO2013012801 has described a kind of intervention heart valve bracket, and it is fixed with polymeric seal unit in or beyond the grid of bottom, in the space after discharging to expanding at support between Stent Implantation and tissue ring.The problem of this support is mainly: the thickness of polymeric seal unit exists bottleneck, and too thick meeting causes loading difficulty, and too thin recovery of shape power is very limited, cannot produce a desired effect; The sealing unit compliance deficiency adopting, can not automatically fill up the recess of irregular tissue ring, and organize ring protuberance can oppress lobe frame by sealing unit on the contrary, thereby affect arrangement for closed configuration and the hemodynamics of valve, even causes more serious perivalvular leakage.
In sum, existing aortic valve stent design can not fully solve the problem of postoperative perivalvular leakage, has a strong impact on the rear living standard of patient, even shortens the life-span.Trace it to its cause, can conclude following some: one, patient's tissue ring is not desirable circle, and most valve bracket is according to circular design.In the time that support compliance is not enough, bracket leg support force is high, and valve bracket maintains circular design after discharging, although valve hemodynamics and open and close function and ensured, tissue ring recess will have perivalvular leakage and occur; In the time that support compliance is good, bracket leg support force is low, and valve bracket is complied with the profile of tissue ring after discharging, and at this moment valve becomes irregular passively, and the protruding place of tissue ring can make valvular deformity, valve hydraulic performance decline; Two, the sealing unit in existing design cannot automatically be filled up the recess of patient tissue ring and comply with its protruding place; Three, water swellability material is used for preventing may having uncontrollable expansion rate and risk of leakage on perivalvular leakage.For above problem, the utility model proposes a kind of novel aortic valve stent, the sealing unit in design plays sealing and auxiliary positioning effect simultaneously, make valve bracket accurately, safety, effectively locate.
Utility model content:
The purpose of this utility model is to provide one can prevent perivalvular leakage conscientiously, the aortic valve stent of accurate positioning simultaneously, sealing unit in this valve bracket has good compliance and shape-memory properties simultaneously, can automatically fill up the recess of patient tissue ring and comply with its protruding place.Described sealing unit has effectively been avoided, because the protruding place of tissue ring compresses the valve bracket distortion that sealing unit causes, protected well valve form and function, and described sealing unit also playing the effect of auxiliary positioning with the means that are connected of Support frame employing.
The purpose of this utility model is achieved through the following technical solutions:
A kind of novel aortic valve stent, comprise support and artificial valve, described support is made up of multiple grid cells, described artificial valve is connected on described grid cell, arranged outside at described support has sealing unit, described sealing unit is made up of metal memory material and by overlay film, under naturalness, described sealing unit axially outwards arches upward along described support, along described support is circumferentially loop configuration, one end dissociative of described sealing unit, for free-end, the other end of described sealing unit is fixed by fixture and described grid cell, for stiff end, when described sealing unit is compressed while entering sheath pipe, described free-end the extending axially along described support of described sealing unit.
Object of the present invention can also further realize by following technical scheme:
Preferably, described sealing unit is subdivided into multiple junior units, and each junior unit all has domes, and described junior unit distributes along the external circumferential of described support, one end dissociative of described junior unit is free-end, and the other end is fixed as stiff end by fixture and described grid cell.
Preferably, described sealing unit is made up of many support bars, and described support bar circularizes along being circumferentially arranged of described support, and fixes by described fixture and described grid cell.
Preferably, described fixture is extended to form by one end of described support bar, and the free side of described fixture and described grid cell are wound around to fix described sealing unit.
Preferably, described sealing unit is wavy shaped configuration or the zigzag structure that metal memory material filament winding system forms, the sawtooth point of the crest of described wavy shaped configuration and trough or the described zigzag structure formation arch that curves inwardly respectively.
Preferred, the diameter of described metal memory material silk is (for example Nitinol) in the scope of 0.01-0.3mm.
Preferred, the sawtooth point place of the crest of described wavy shaped configuration and trough or described zigzag structure is turned to annular.
Preferred, between the adjacent bar of described sealing unit, be mutually wound around, form structure closely, so that larger elastic-restoring force to be provided.
Preferably, described fixture is fixing silk, and a side of described fixture and described grid cell are wound around, and the opposite side of described fixture is fixed in crest or the trough of described wavy shaped configuration, or on the sawtooth point of described zigzag structure.
Preferably, described fixture is by multiple crests or the trough of described wavy shaped configuration, or multiple sawtooth points of described zigzag structure further extend to form, and the free side of described fixture and described grid cell are wound around.
Preferably, described fixture is suture, and the described stiff end of described sealing unit is wound around by described suture and described grid cell or knotting is fixed.
Preferred, some holes are set on described grid cell, described fixture is through the fastening described sealing unit in described hole.
Preferably, the mode that described film adopts welding, gummed or seam to tie up is connected with described sealing unit, and the material of described film comprises politef, polyethylene, polypropylene, terylene or animal derived material.
Preferably, described support is made by marmem, and described aortic valve stent is self-expandable stent.
Preferably, the described stiff end of described sealing unit and described artificial valve's bottom are positioned on same level line.
Compared with the existing technology, the utility model has the advantage of:
1, the sealing unit in a kind of novel aortic valve stent of the present utility model adopts metal memory material overlay film, soft and do not lose reply intensity, there is good compliance and shape-memory properties simultaneously, can automatically fill up the recess of patient tissue ring and comply with its protruding place;
2, sealing unit one end dissociative (free-end) in this utility model, the other end (stiff end) is fixed with support, in pressure sheath process, the free-end of sealing unit can extend axially along support, reduce sheathe diameter, significantly reduce the stimulation to patient vessel, reduced vascular complication risk;
3, the sealing unit that this utility model adopts can be pushed patient tissue lobe leaf open, and plays the effect of auxiliary positioning.
Brief description of the drawings
Fig. 1 shows the schematic diagram of a kind of novel aortic valve stent of the present utility model, and wherein Fig. 1 a is front view, and Fig. 1 b is top view, and Fig. 1 c and 1d show respectively the schematic diagram of described sealing unit in the time of release and sheathe.
Fig. 2 a shows the schematic diagram of sealing unit in a preferred embodiment of the present utility model, and Fig. 2 b shows the fixed form schematic diagram of sealing unit and grid cell in another preferred embodiment of the present utility model.
Fig. 3 a-d shows in a preferred embodiment, the fixed form schematic diagram of sealing unit and support.
Fig. 4 shows a kind of release schematic diagram of novel aortic valve stent, wherein Fig. 4 a and Fig. 4 b show a kind of novel aortic valve stent dispose procedure gradually, Fig. 4 c shows a kind of novel aortic valve stent and is positioned at patient tissue ring place, and Fig. 4 d shows a kind of novel aortic valve stent and be positioned at the top view at patient tissue ring place.
Fig. 5 shows the schematic diagram of a kind of novel aortic valve stent of the present utility model, and wherein Fig. 5 a is front view, and Fig. 5 b is top view, and Fig. 5 c shows the schematic diagram of the position of described sealing unit on support.
Fig. 6 shows a kind of release schematic diagram of novel aortic valve stent, wherein Fig. 6 a and Fig. 6 b show a kind of novel aortic valve stent dispose procedure gradually, Fig. 6 c shows a kind of novel aortic valve stent and is positioned at patient tissue ring top, and Fig. 6 d shows the top view that a kind of novel aortic valve stent is positioned at patient tissue ring top and pushes original tissue flap open.
Fig. 7 a and Fig. 7 b show the structural representation of sealing unit in another preferred embodiment of the present invention, Fig. 7 c shows the schematic diagram that a side of fixture in a preferred embodiment is connected with sealing unit, Fig. 7 d is the local enlarged diagram of Fig. 7 c, and Fig. 7 e shows the structural representation of fixture in a preferred embodiment.
Fig. 8 shows the schematic diagram of a kind of novel aortic valve stent of the present utility model, and wherein Fig. 8 a is front view, and Fig. 8 b is top view, and Fig. 8 c shows the schematic diagram of described sealing unit and grid cell fixed form.
Fig. 9 a and 9b show the structural representation of sealing unit in another preferred embodiment of the present invention, and Fig. 9 c shows the further schematic diagram of extension of multiple sawtooth points of zigzag structure described in a preferred embodiment.
Detailed description of the invention:
For making the purpose of this utility model, technical scheme and advantage clearer, referring to the accompanying drawing embodiment that develops simultaneously, this utility model is further described.
Near-end described in the utility model refers to one end of the person that approaches operation technique, and described far-end refers to the one end away from operation technique person.
Specific embodiment one:
As shown in Fig. 1 a-d, a kind of novel aortic valve stent 100, comprise support 110 and artificial valve 104, described support 110 is made up of multiple grid cells 112, described artificial valve 104 is connected on described grid cell 112, there is sealing unit 106 in the arranged outside of described support 110, described sealing unit 106 is made up of metal memory material and by overlay film, under naturalness, described sealing unit 106 axially outwards arching upward along described support, along described support is circumferentially loop configuration, one end dissociative of described sealing unit 106, for free-end 116, the other end of described sealing unit 106 is fixing with described grid cell 112 by fixture 138, for stiff end 126, when described sealing unit 106 is compressed while entering sheath pipe 130, described free-end 116 the extending axially along described support 110 of described sealing unit 106, the design of described free-end 116 has reduced sheathe diameter, significantly reduce the stimulation to patient vessel, reduce vascular complication risk.
As shown in Figure 2 a, nitinol alloy wire that described sealing unit 106 adopts diameter (to be preferably 0.08mm) between 0.01-0.3mm is made and by overlay film 146, the material of described film 146 comprises politef, polyethylene, polypropylene, terylene etc. or animal derived material, and its mode that adopts welding, gummed or seam to tie up is connected with described sealing unit 106.Under naturalness, described sealing unit 106 axially outwards arching upward along described support, along described support is circumferentially loop configuration, compare other existing data, as the polymeric seal unit without any metallic support adopting in patent WO2013012801, the design's benefit is, the nitinol alloy wire of this size is neither too hard, nor too soft, can either improve elastic-restoring force, keeping sealing unit 106 is domes along the axial of described support, can keep again soft to comply with the variation of patient tissue ring profile; And described sealing unit 106 along described support be circumferentially loop configuration, can comprehensive, seamlessly leak stopping, raising prevents the effect of perivalvular leakage.As one preferred embodiment, described sealing unit 106 is made up of many arcuation support bars 137, described support bar 137 circularizes along being circumferentially arranged of described support, not contact between described support bar 137, can find separately independently and fill up the recess of patient tissue ring, while complying with high spot, can not drive adjacent support bar (137a, 137b, 137c...) yet, guarantee to prevent the effect of perivalvular leakage.As one preferred embodiment, as shown in Figure 2 b, described support bar 137 is fixing with described grid cell 112 by described fixture 138.Described fixture 138 is extended to form by one end of described support bar 137, and the free side of described fixture 138 and described grid cell 112 are wound around to fix described sealing unit.
As another preferred embodiment, as shown in Figure 3 a, described fixture is suture 139, and the stiff end 126 of described sealing unit 106 adopts described suture 139 be wound around or tie a knot fixing with described grid cell 112.On described grid cell 112, single hole 118 is set, thus the fixing described sealing unit 106 in the hole described in 139 grapplings of described suture 118.As another preferred embodiment, as shown in Figure 3 b, described suture 139 is wound around 3 circles on grid cell 112, and ties a knot by described hole 118, thereby reaches the object of fastening described sealing unit.As another preferred embodiment, diplopore (118a, 118b) is set on described grid cell 112, as shown in Fig. 3 c and 3d, to further improving the fixed effect of described suture 139.
Described support 110 is made by marmem, and described aortic valve stent 100 is self-expandable stent.Described aortic valve stent 100 is carried through the apex of the heart, and when the sheath pipe 130 that is loaded with described aortic valve stent 100 arrives target location, sheath pipe 130 retreats, and progressively discharges aortic valve stent 100.As shown in Fig. 4 a, at the release initial stage, support is not replied original shape yet completely, and the grid cell that is positioned at rack far end discharges gradually, and the described sealing unit 106 that is at this time positioned at mount proximal end is still positioned at sheath pipe 130; As shown in Figure 4 b, the described sealing unit 106 that is positioned at mount proximal end is because the extended state of its restoring force when pressing sheath replied as circular arch state, and at this moment capable of regulating aortic valve stent 100 positions, allow described sealing unit 106 be positioned at tissue and encircle on 156; As shown in Fig. 4 c, along with sheath pipe 130 continues to retreat, the increasing grid cell 112 of support is released, sealing unit 106 also radially expands with support 110, described sealing unit 106 returns back to initial condition gradually, at this moment doctor can observe by monitoring means the situation of perivalvular leakage, adjusts at any time aortic valve stent position and direction; As shown in Fig. 4 d; after aortic valve stent discharges completely; described sealing unit 106 is between described support 110 and tissue ring 156; there is good compliance and shape-memory properties simultaneously; can automatically fill up the recess of patient tissue ring 156 and comply with its protruding place; and avoid, because the protruding place of tissue ring compresses the valve bracket distortion that sealing unit causes, protecting well form and the function of valve 104.
Specific embodiment two:
As shown in Fig. 5 a and Fig. 5 b, a kind of novel aortic valve stent 200, comprise support 210 and artificial valve 204, described support 210 is made up of multiple grid cells 212, described artificial valve 204 is connected on described grid cell 212, there is sealing unit 206 in the arranged outside of described support 210, described sealing unit 206 is made up of metal memory material and by overlay film, under naturalness, described sealing unit 206 axially outwards arching upward along described support, along described support is circumferentially loop configuration, one end dissociative of described sealing unit 206, for free-end 216, the other end of described sealing unit 206 is fixing with described grid cell 212 by fixture 238, for stiff end 226, when described sealing unit 206 is compressed while entering sheath pipe, described free-end 216 the extending axially along described support 210 of described sealing unit 206.Stiff end 226 and described artificial valve 204 bottoms 2040 of described sealing unit 206 are positioned on same level line, and such design is mainly in order to utilize described sealing unit 206 to realize auxiliary positioning; Next is to allow described sealing unit 206 push the original tissue flap of patient open, prevents that original tissue flap from attaching described support 210, affects coronary blood supply; Be finally to allow described artificial valve 204 be positioned at valve annulus tissue realize above ring mo(u)ld top half, increase aperture area.
As shown in Figure 6 a, at the release initial stage, support is not replied original shape yet completely, and now the free-end 216 of described sealing unit 206 is still close to described support 210; As shown in Figure 6 b, in the time that described support further discharges, the free-end 216 of described sealing unit 206 is because its restoring force is to mount proximal end resilience, extended state during from pressure sheath is replied as circular arch state, at this moment capable of regulating aortic valve stent 200 positions, allow the described sealing unit 206 of circular arch state find patient tissue ring 156 positions, and be placed on tissue ring 156 tops; As shown in Fig. 6 c and Fig. 6 d, along with sheath pipe 130 continues to retreat, the increasing grid cell 212 of support is released, sealing unit 206 also radially expands with support 210, described sealing unit 206 returns back to initial condition gradually, at this moment doctor can observe by monitoring means the situation of perivalvular leakage, adjusts at any time aortic valve stent position and direction; After aortic valve stent discharges completely; described sealing unit 206 is positioned on tissue ring 156; described sealing unit 206 is pushed original tissue flap 158 open; avoid it to affect coronary blood supply; described sealing unit 206 has good compliance and shape-memory properties simultaneously; can automatically fill up the recess of patient tissue ring 156 and tissue flap 158 and comply with its protruding place; and avoid, because the protruding place of tissue ring compresses the valve bracket distortion that sealing unit 206 causes, protecting well form and the function of valve 204.
As one preferred embodiment, as shown in Figure 7a, the material of described sealing unit 206 is the wavy shaped configuration that the nitinol alloy wire coiling of diameter 0.2mm forms.As shown in Figure 7b, the crest 236a of described wavy shaped configuration and trough 236b curve inwardly respectively and form dome-shaped by inside and outside overlay film 246, the material of described film 246 is politef, and the mode that adopts welding, gummed or seam to tie up is connected with described sealing unit 206.Than many circular arch shape support bars independently, the benefit of design is to provide the cross-brace power perpendicular to Wave crest and wave trough line like this, the sealing unit that makes to be pressed into sheath pipe can better extending transversely in the time discharging, fill up more vacancy, avoid sealing unit to be extruded agglomerating, impact prevents perivalvular leakage function.As one preferred embodiment, as shown in Figure 7 c, described fixture 238 is fixing silk, and a side and the described grid cell 212 of described fixture 238 are wound around, and the other end of described fixture 238 is fixed on the trough 236 of described wavy shaped configuration.As another preferred embodiment, the crest 236a of described wavy shaped configuration and trough 236b are turned to annular 256, as shown in Fig. 7 d, the free side of described fixture 238 is fixing with described sealing unit 206 through described annular 256, and more firmly fixed effect is provided.As one preferred embodiment, as shown in Fig. 7 e, described fixture 238 is rivet, realize fixing through the hole 218 on described grid cell 212, described sealing unit 206 is returned to the process of naturalness from compressive state, the free-end 216 of described sealing unit 206 moves toward near-end, and described sealing unit 206 returns back to arch gradually simultaneously.
Specific embodiment three:,
As shown in Fig. 8 a-c, be with above-mentioned specific embodiment difference, described sealing unit is subdivided into 9 junior unit 307 (307a, 307b, 307c......), each unit 307 all has domes, and described junior unit 307 distributes along the external circumferential of described support 310, one end dissociative of described junior unit 307 is free-end 317, and the other end is fixed as stiff end 327 by fixture 338 and described grid cell 312.Design has reduced sealing unit and has been subject to the traction of overlay film like this, be conducive to described sealing unit overturns in the time of sheathe, in the time discharging, restore to the original state rapidly, and after release, fill up the recess of patient tissue ring independently, comply with the protrusion place of patient tissue ring, degree of freedom is larger, prevents that perivalvular leakage effect is better.
As shown in Fig. 9 a, the zigzag structure that described sealing unit 306 forms for metal memory material filament winding system, the sawtooth point 366 of described zigzag structure inwardly curves respectively arch.As the preferred embodiment of another kind, as shown in Fig. 9 b, between the adjacent bar 337a of described sealing unit 306 and 337b, be mutually wound around, form structure closely, retrain the cross directional stretch distance between support bar 337 on the one hand, larger restoring force is provided, prevented especially that on the other hand support bar 337 from misplacing in overlay film 346, to form evenly fine and closely woven framing structure, greatly improve and prevent perivalvular leakage effect.As the preferred embodiment of another kind, as shown in Fig. 9 c, described fixture 338 is further extended to form by multiple sawtooth points 366 of described zigzag structure, and the free side of described fixture 338 and described grid cell are wound around.
Finally should be noted that; the foregoing is only preferred embodiment of the present invention; not in order to limit the present invention, all any amendments of doing within the spirit and principles in the present invention, be equal to and replace and improvement etc., within all should being included in protection scope of the present invention.
Claims (13)
1. a novel aortic valve stent, comprise support and artificial valve, described support is made up of multiple grid cells, described artificial valve is connected on described grid cell, it is characterized in that, arranged outside at described support has sealing unit, described sealing unit is made up of metal memory material and by overlay film, under naturalness, described sealing unit axially outwards arches upward along described support, along described support is circumferentially loop configuration, one end dissociative of described sealing unit, for free-end, the other end of described sealing unit is fixed by fixture and described grid cell, for stiff end, when described sealing unit is compressed while entering sheath pipe, described free-end the extending axially along described support of described sealing unit.
2. novel aortic valve stent according to claim 1, it is characterized in that, described sealing unit is subdivided into multiple junior units, each junior unit all has domes, described junior unit distributes along the external circumferential of described support, one end dissociative of described junior unit is free-end, and the other end is fixed as stiff end by fixture and described grid cell.
3. novel aortic valve stent according to claim 1 and 2, it is characterized in that, described sealing unit is made up of many support bars, and described support bar circularizes along being circumferentially arranged of described support, and fixes by described fixture and described grid cell.
4. novel aortic valve stent according to claim 3, is characterized in that, described fixture is extended to form by one end of described support bar, and free side and the described grid cell of described fixture are wound around to fix described sealing unit.
5. novel aortic valve stent according to claim 1 and 2, it is characterized in that, described sealing unit is wavy shaped configuration or the zigzag structure that metal memory material filament winding system forms, the sawtooth point of the crest of described wavy shaped configuration and trough or the described zigzag structure formation arch that curves inwardly respectively.
6. novel aortic valve stent according to claim 5, is characterized in that, the diameter of described metal memory material silk is in the scope of 0.01-0.3mm.
7. novel aortic valve stent according to claim 5, is characterized in that, the sawtooth point place of the crest of described wavy shaped configuration and trough or described zigzag structure is turned to annular.
8. novel aortic valve stent according to claim 5, is characterized in that, between the adjacent bar of described sealing unit, is mutually wound around.
9. novel aortic valve stent according to claim 5, it is characterized in that, described fixture is fixing silk, one side of described fixture and described grid cell are wound around, the opposite side of described fixture is fixed in crest or the trough of described wavy shaped configuration, or on the sawtooth point of described zigzag structure.
10. novel aortic valve stent according to claim 5, it is characterized in that, described fixture is by multiple crests or the trough of described wavy shaped configuration, or multiple sawtooth points of described zigzag structure further extend to form, the free side of described fixture and described grid cell are wound around.
11. novel aortic valve stent according to claim 1 and 2, is characterized in that, described fixture is suture, and the described stiff end of described sealing unit is wound around by described suture and described grid cell or knotting is fixed.
12. according to the novel aortic valve stent described in claim 1,2,4,9 or 10, it is characterized in that, some holes are set on described grid cell, and described fixture is through the fastening described sealing unit in described hole.
13. novel aortic valve stent according to claim 1, is characterized in that, the described stiff end of described sealing unit and described artificial valve's bottom are positioned on same level line.
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| CN201320813283.2U CN203736349U (en) | 2013-12-12 | 2013-12-12 | Novel aorta valve stent |
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| CN201320813283.2U CN203736349U (en) | 2013-12-12 | 2013-12-12 | Novel aorta valve stent |
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| CN107411849A (en) * | 2017-08-24 | 2017-12-01 | 北京航空航天大学 | Anti- perivalvular leakage is through conduit valve system and method for implantation |
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| CN109771098A (en) * | 2018-03-13 | 2019-05-21 | 唐杨烽 | A kind of mitral valve replacement manually mechanical prosthetic valve on ring |
| CN109771099B (en) * | 2018-03-13 | 2023-09-22 | 中国人民解放军海军军医大学第一附属医院 | Mechanical valve on artificial ring for replacing mitral valve |
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| US11877927B2 (en) | 2020-07-07 | 2024-01-23 | Anteris Technologies Corporation | Expandable frame for improved hemodynamic performance of transcatheter replacement heart valve |
| WO2022164811A1 (en) * | 2021-01-26 | 2022-08-04 | Edwards Lifesciences Corporation | 3-d shaped skirts for prosthetic heart valves |
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Address after: Building 5, area B, 777 Binhai Fourth Road, Hangzhou Bay New District, Ningbo City, Zhejiang Province, 315336 Patentee after: Ningbo Jianshi Technology Co.,Ltd. Address before: 315336 zone B, No. 558 Binhai 4th Road, Hangzhou Bay New Area, Ningbo, Zhejiang Patentee before: NINGBO JENSCARE BIOTECHNOLOGY Co.,Ltd. |
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Granted publication date: 20140730 |