CN103705315B - Prevent the aortic valve stent of perivalvular leakage - Google Patents
Prevent the aortic valve stent of perivalvular leakage Download PDFInfo
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- CN103705315B CN103705315B CN201310671694.7A CN201310671694A CN103705315B CN 103705315 B CN103705315 B CN 103705315B CN 201310671694 A CN201310671694 A CN 201310671694A CN 103705315 B CN103705315 B CN 103705315B
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- perivalvular leakage
- valve stent
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- 210000001765 aortic valve Anatomy 0.000 title claims abstract description 52
- 238000007789 sealing Methods 0.000 claims abstract description 149
- 239000000463 material Substances 0.000 claims abstract description 22
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- 238000005452 bending Methods 0.000 claims description 19
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- 239000012781 shape memory material Substances 0.000 claims description 5
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- 238000003466 welding Methods 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 3
- 239000004743 Polypropylene Substances 0.000 claims description 3
- 229920004933 Terylene® Polymers 0.000 claims description 3
- 239000013536 elastomeric material Substances 0.000 claims description 3
- 229920000573 polyethylene Polymers 0.000 claims description 3
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 3
- 229920001155 polypropylene Polymers 0.000 claims description 3
- 238000009730 filament winding Methods 0.000 claims description 2
- 238000010586 diagram Methods 0.000 description 16
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- 229910001000 nickel titanium Inorganic materials 0.000 description 6
- 229910045601 alloy Inorganic materials 0.000 description 5
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- 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
- 238000007599 discharging Methods 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 4
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- 210000000709 aorta Anatomy 0.000 description 3
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- 208000009087 False Aneurysm Diseases 0.000 description 1
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- 206010058360 Retroperitoneal haematoma Diseases 0.000 description 1
- 206010048975 Vascular pseudoaneurysm Diseases 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
A kind of aortic valve stent (100) preventing perivalvular leakage, comprise support (110) and artificial valve (104), described support (110) is made up of multiple grid cell (112), described artificial valve (104) is connected on described grid cell (112), the bottom of described support (110) is provided with sealing unit (106), described sealing unit (106) is made up and film of metal memory material, in its natural state, described sealing unit (106) outwards arches upward along the axis of described support, circumference along described support (110) is loop configuration, one end dissociative of described sealing unit (106), for free-end (116), the other end of described sealing unit (106) is fixed by the bottom of fixture and support (110), for stiff end (126), when described sealing unit (106) is compressed into into sheath pipe, the free-end (116) of sealing unit (106) overturns around the bottom of stiff end (126) to support, make sealing unit (106) not overlapping with support (110).
Description
Technical field:
The invention belongs to medical instruments field, be specifically related to a kind of aortic valve stent preventing perivalvular leakage.
Background technology:
Aortic stenosis is the common valvular heart disease of old people, and the sickness rate of 75-85 year patient is about 4%, and the age, the patient more than 85 years old was then increased to about 7%.Aortic stenosis incidence rate wherein caused by calcific aortic valve reaches 2%-7%, and with advancing age, its ratio increases all the more, has become one of Aged Heart Failure, arrhythmia, the major reason of fainting and dying suddenly.Traditional Therapeutic Method first elects surgery valve replacement, but for advanced age, Lower cardiac function or and have the patient of multiple complications then mortality rate be very high, in addition conservative drug treatment and balloon expandable two kinds of therapeutic modalities more after not good, complication and relapse rate high.
Since 2002, Cribier etc. take the lead in reporting first case human body percutaneous aortic valve replacement art example, make to become numerous another kind of therapeutic choice that cannot accept the patient of surgical intervention through conduit aortic valve replacement (Transcatheter Aortic Valve Implantation, TAVI).For many years, TAVI is flourish, and all kinds of apparatus and technology are developed in succession, TAVI is become be not suitable for the first-selection of the high-risk group of traditional surgery.There are direct motion method (through femoral vein-right atrium-puncture interatrial septum-left atrium-Bicuspid valve-left ventricle-aortic valvular ring), Retrograde (through femoral artery-ventral aorta-descending aorta-aortic arch-aortic valvular ring) in the intervention path of current employing, through apex of the heart puncture method, through subclavian artery, through aorta etc., these intervention means cut both ways, but with Retrograde and comparatively common through apex of the heart puncture method.
At present, clinical effectiveness tells us, although the medium-long term curative effect of TAVI can match in excellence or beauty with traditional operation treatment, it is faced with a complication high-technology difficult problem for perioperative equally.Perivalvular leakage causes each side to pay attention to as one of severe complication, many parts of large-scale clinical trials result displays, perivalvular leakage almost sees the patient after all TAVI, wherein, in, severe perivalvular leakage see about 20% postoperative patient, greatly have impact on more after quality of life.Meanwhile, blood vessel injury etc. also appear in the newspapers repeatly, cause retroperitoneal hematoma, artery dissection, false aneurysm to be formed, jeopardize patient's survival rate.Research staff has to Continual Improvement technical scheme and carry out apparatus innovation, to improve patient's survival rate, improves minimal invasive treatment's situation.
In patent US7445631, Sadra discloses a aortic valve braided support, and fix by macromolecule or the made shirt rim of pericardium material to alleviating perivalvular leakage at frame bottom laminating support grid, such design can play certain anti-perivalvular leakage effect, but it is comparatively large to load sheath pipe, thus its application can be limited.
In patent EP1980220, JenaValve proposes a aortic valve stent through apex of the heart conveying, and this patent comparatively at large describes by clamping former calcified valves to reach the effect reducing perivalvular leakage.However, when the gap of patient's calcified valves is originally irregular or when not closing up, this design cannot improve perivalvular leakage situation; And its folder lobe designs and is not suitable for aorta bilobed flap patient.Clinical effectiveness also shows that this design will cause patient's pressure gradient to improve, and affects the treatment.
A kind of ascending aorta inner cavity insulation support fixing capsule with filled-type is proposed in patent CN201120022195, its outside at overlay film straight tube support is sewed up or is bonded with filled-type and fixes capsule, capsule is built with water absorbing material, it can in Ink vessel transfusing imbibition, thus play fixed support, prevent the effect be shifted.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, and once these water absorbing material leak into outside capsule, then can bring huge risk, jeopardizes patient vitals's safety.
Patent WO2013012801 describes a kind of intervention heart valve bracket, and it is fixed with polymeric seal unit in or beyond the grid of bottom, to discharging rear Stent Implantation at stent expansion and organizing in the space between 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 then recovery of shape power is very limited, cannot produce a desired effect; The sealing unit compliance adopted is not enough, automatically can not fill up the irregular recess organizing ring, and organize ring protuberance can oppress lobe frame by sealing unit on the contrary, thus affect arrangement for closed configuration and the hemodynamics of valve, even cause more serious perivalvular leakage.
In sum, existing aortic valve stent design fully can not 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, the ring of organizing of patient is not desirable circle, and most valve bracket is according to circular design.When support compliance is not enough, support support force is high, maintains circular design after valve bracket release, although valve hemodynamics and opening and closing function are ensured, organizes ring recess will have perivalvular leakage and occurs; When support compliance is good, support support force is low, and comply with the profile organizing ring after valve bracket release, at this moment valve becomes irregular passively, organizes the convex place of ring can make valvular deformity, valve hydraulic performance decline; Two, the sealing unit in existing design automatically cannot be filled up the recess of patient tissue ring and comply with its convex place; Three, the part sealing unit in existing design can cause sheathe difficulty, increases sheath pipe diameter, may cause serious vascular complication after using; Four, by water swellable material for preventing that perivalvular leakage may exist uncontrollable expansion rate and risk of leakage.For above problem, the present invention proposes a kind of aortic valve stent that conscientiously can prevent perivalvular leakage, does not expand sheath pipe diameter simultaneously, avoids vascular complication risk.
Summary of the invention:
The object of this invention is to provide one and conscientiously can prevent perivalvular leakage, do not expand the aortic valve stent of sheath pipe diameter simultaneously, sealing unit in this valve bracket has good compliance and shape-memory properties simultaneously, automatically can fill up the recess of patient tissue ring and comply with its convex place.The connection means that described sealing unit and Support frame adopt effectively prevent because organizing the convex place of ring to compress that valve bracket that sealing unit causes is out of shape; protect valve form and function well; and the described free-end of sealing unit can overturn around the bottom of described stiff end to support described in sheathe process; therefore sheathe diameter can not be expanded; significantly reduce the stimulation to patient vessel, reduce vascular complication risk.
The object of the invention is to be achieved through the following technical solutions:
A kind of aortic valve stent preventing perivalvular leakage, comprise support and artificial valve, described support is made up of multiple grid cell, described artificial valve is connected on described grid cell, the bottom of described support is provided with sealing unit, described sealing unit is made up and film of metal memory material, in its natural state, described sealing unit outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit, for free-end, the other end of described sealing unit is fixed by the bottom of fixture and described support, for stiff end, when described sealing unit is compressed into into sheath pipe, the described free-end of described sealing unit overturns around the bottom of described stiff end to described support, make described sealing unit not overlapping with described support.
Object of the present invention can also be realized further by following technical scheme:
Preferably, described sealing unit is subdivided into multiple junior unit, and each junior unit all has domes, and described junior unit distributes along the external circumferential of described support, described junior unit one end dissociative is free-end, and the other end is fixed as stiff end by the bottom of fixture and described support.Be designed with like this and help described sealing unit and overturn when sheathe.
Preferably, described sealing unit is made up of many support bars, and described many support bars circularize along being circumferentially arranged of described support, and described support bar is fixed by the bottom of described fixture and described support.
Preferably, described fixture is extended to form by one end of described support bar, and the free side of described fixture and the grid cell of described frame bottom are wound around with fixing described sealing unit.
Preferred, the described grid cell of described frame bottom arranges some holes, and the described free side of described fixture is passed or the fastening described sealing unit in hole described in grappling.
Preferably, described sealing unit is wavy shaped configuration or the zigzag structure of metal memory material filament winding system, and the sawtooth point of the crest of described wavy shaped configuration and trough or described zigzag structure overarches respectively to inflection.
Preferred, the diameter (such as Nitinol) in the scope of 0.01-0.3mm of described metal memory material silk.
Preferred, the sawtooth point place of the crest of described wavy shaped configuration and trough or described zigzag structure is turned to annular, so that described sealing unit is securely fixed on described support.
Preferred, be mutually wound around between the adjacent bar of described sealing unit, form structure closely, to provide larger elastic-restoring force.
Preferred, described fixture is fixing silk, and the side of described fixture and the grid cell of described frame bottom are wound around, and the other end of described fixture is fixed in crest or the trough of described wavy shaped configuration, or on the sawtooth point of described zigzag structure.
Preferred, described fixture is by multiple crest of described wavy shaped configuration or trough, or multiple sawtooth points of described zigzag structure extend to form further, and the free side of described fixture and the grid cell of described frame bottom are wound around.
Preferred, the described grid cell of described frame bottom arranges some holes, and described fixture is through the fastening described sealing unit in described hole.
Preferred, described fixture is provided with the bending part through thermal finalization, and described bending part is apart from the described stiff end 0 ~ 8mm of described sealing unit.
Preferred, adjacent described bending part apart from described frame bottom length not etc.
Preferably, described film adopts welding, gummed or stitches the mode of tying up and is connected with described sealing unit, and described membrane material comprises politef, polyethylene, polypropylene, terylene or animal derived material.
Preferably, be provided with reply unit in described sealing unit, one end of described reply unit is connected with described sealing unit, and the other end of described reply unit is connected with described support, and described reply unit is elastic element.During sheathe, described sealing unit upset, this reply unit is stretched and is overlapping into sheath with described support; After described sealing unit goes out sheath, described sealing unit is returned back to original state by the pulling force that this reply unit provides, to realize the function preventing perivalvular leakage.
Preferred, described reply unit is by shape-memory material wound into spring shape, waveform or zigzag, or described reply unit is made up of elastomeric material.Most preferred, described shape-memory material is nitinol alloy wire.
Preferred, the two ends of described reply unit adopt weld, glue together, tie around or the seam mode of tying up be connected with described sealing unit and described support respectively.
Preferably, described support is made by marmem, and described aortic valve stent is self-expandable stent.
Compared with the existing technology, the invention has the advantages that:
1, of the present invention prevent the sealing unit in the aortic valve stent of perivalvular leakage from adopting metal memory material and overlay film, soft and do not lose reply intensity, there is good compliance and shape-memory properties simultaneously, automatically can fill up the recess of patient tissue ring and comply with its convex place;
2, sealing unit one end dissociative (free-end) in the present invention, the other end (stiff end) and frame bottom are fixed, in pressure sheath process, the free-end of sealing unit can around its stiff end to the bottom upset of support and along support axially extension, sealing unit is not overlapping with Support frame, reduce sheathe diameter, significantly reduce the stimulation to patient vessel, reduce vascular complication risk;
3, the connection means that sealing unit of the present invention and support adopt effectively prevent because organizing the convex place of ring to compress that valve bracket that sealing unit causes is out of shape, and protect form and the function of valve well.
Accompanying drawing explanation
Fig. 1 shows the schematic diagram preventing the aortic valve stent of perivalvular leakage of the present invention, and wherein Fig. 1 a is front view, and Fig. 1 b is top view.
Fig. 2 a shows the schematic diagram of sealing unit in a preferred embodiment of the present invention, and Fig. 2 b shows the fixed form schematic diagram of the grid cell of sealing unit and frame bottom in another preferred embodiment of the present invention.
Fig. 3 a-d shows in a preferred embodiment, the fixed form schematic diagram of sealing unit and support.
Fig. 4 a and 4b shows the sheathe schematic diagram of the aortic valve stent preventing perivalvular leakage.
Fig. 5 shows the release schematic diagram of the aortic valve stent preventing perivalvular leakage, wherein Fig. 5 a and Fig. 5 b shows the aortic valve stent dispose procedure gradually preventing perivalvular leakage, Fig. 5 c shows and prevents the aortic valve stent of perivalvular leakage to be positioned at patient tissue ring place, and Fig. 5 d shows the top view preventing the aortic valve stent of perivalvular leakage to be positioned at patient tissue ring place.
Fig. 6 a and 6b shows the schematic diagram preventing the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention.
Fig. 7 a and 7b shows the structural representation of sealing unit in the present invention's preferred embodiment.
Fig. 8 a shows the structural representation of sealing unit in another preferred embodiment of the present invention, and the fixation side that Fig. 8 b shows sealing unit in a preferred embodiment extends the schematic diagram of multiple extension, and Fig. 8 c is the close-up schematic view of Fig. 8 b.
Fig. 9 a and 9b shows the structural representation of sealing unit in another preferred embodiment of the present invention, Fig. 9 c shows multiple crest or the trough of the wavy shaped configuration described in a preferred embodiment, or multiple sawtooth points of described zigzag structure extend to form the schematic diagram of extension further.
Figure 10 a and 10b shows the carved pattern of the present invention's preferred embodiment medium-height trestle, and Figure 10 c-Figure 10 g shows the fixed form schematic diagram of the grid cell of sealing unit and frame bottom.
Figure 11 a and Figure 11 b shows the schematic diagram preventing the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention.
Figure 12 a and Figure 12 b shows the schematic diagram of replying unit.
Figure 13 a and Figure 13 b shows the schematic diagram preventing the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention, and Figure 13 c and Figure 13 d shows the fixed form schematic diagram of junior unit and support.
Figure 14 a and Figure 14 b shows the fixed form schematic diagram of junior unit and support in a preferred embodiment.
Figure 15 shows the fixed form schematic diagram of junior unit and support in another preferred embodiment.
Detailed description of the invention:
For making object of the present invention, technical scheme and advantage clearly understand, to develop simultaneously embodiment referring to accompanying drawing, the present invention is described in more detail.
Near-end of the present invention refers to the one end close to operator, and described far-end refers to the one end away from operator.
Specific embodiment one:
As illustrated in figs. ia and ib, a kind of aortic valve stent 100 preventing perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is made up of multiple grid cell 112, described artificial valve 104 is connected on described grid cell 112, the bottom of described support 110 is provided with sealing unit 106, described sealing unit 106 is made up and film of metal memory material, in its natural state, described sealing unit 106 outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit 106, for free-end 116, the other end of described sealing unit 106 is fixed by the bottom of fixture and described support 110, for stiff end 126, when described sealing unit 106 is compressed into into sheath pipe, the described free-end 116 of described sealing unit 106 overturns around the bottom of described stiff end 126 to described support, make described sealing unit 106 not overlapping with described support 110, do not need to expand sheathe diameter.
As shown in Figure 2 a, described sealing unit 106 adopts the nitinol alloy wire of diameter 0.08mm made and film 146, the material of described film 146 comprises politef, polyethylene, polypropylene, terylene etc. or animal derived material, and it adopts welding, gummed or stitch the mode of tying up and is connected with described sealing unit 106.In its natural state, described sealing unit 106 outwards arches upward along the axis of described support, circumference along described support is loop configuration, compare other existing data, as the polymeric seal unit without any metallic support adopted in patent WO2013012801, the benefit of the design is, the nitinol alloy wire of this size is neither too hard, nor too soft, elastic-restoring force can either be improved, keep sealing unit 106 to be domes along the axis of described support, can keep again soft to comply with the change of patient tissue ring profile; And described sealing unit 106 is loop configuration along the circumference of described support, can comprehensive, seamlessly leak stopping, improve the effect preventing perivalvular leakage.As one preferred embodiment, described sealing unit 106 is many arcuation support bars 137, described many support bars 137 circularize 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, also can not drive adjacent support bar (137a, 137b, 137c...) when complying with high spot, guarantee the effect preventing perivalvular leakage.As one preferred embodiment, as shown in Figure 2 b, described support bar 137 is fixed with the bottom of described support 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 the grid cell 112 of described frame bottom are wound around with fixing described sealing unit.As another preferred embodiment, as shown in Figure 3 a, the grid cell 112 of described frame bottom arranges single hole 118, the free side anchor of described fixture 138 determines described hole 118 thus fixing described sealing unit 106.Described fixture 138 is provided with the bending part 140 through thermal finalization, described bending part 140 is positioned at the stiff end 128 about 3mm place apart from described sealing unit, when described sealing unit 106 again discharges after being compressed into sheath pipe, described sealing unit 106 relies on described bending part 140 to provide elastic-restoring force, and the free fraction of described sealing unit 106 is fitted naturally with rack outer surface again.As another preferred embodiment, as shown in Figure 3 b, the free side of described fixture 138 is wound around 3 circles on grid cell 112, and is tied a knot by described hole 118, thus reaches the object of fastening described sealing unit.As another preferred embodiment, the grid cell of described frame bottom is arranged diplopore (118a, 118b), as shown in figs. 3 c and 3d, to improving the fixed effect of described fixture 138 further.
As shown in Figs. 4a and 4b, described support 110 is made by marmem, and described aortic valve stent 100 is self-expandable stent.During sheathe, the free-end 116 of described sealing unit 106 axially overturns around the bottom (far-end) of described stiff end 126 to support along support, in sheath pipe 130, described sealing unit 106 is not overlapping with described support 110, thus reaches the object reducing sheathe diameter.When the sheath pipe 130 being loaded with described aortic valve stent arrives target location, sheath pipe 130 retreats, and progressively discharges aortic valve stent 100.As shown in Fig. 5 a-d, the release initial stage, support replys original shape not yet completely, be positioned at the described sealing unit 106 of support bottom (far-end) because its restoring force is to mount proximal end resilience, reply as circular arch state from extended state during pressure sheath, at this moment adjustable aortic valve stent 100 position, allows described sealing unit 106 be positioned at and organizes on ring 156; Along with sheath pipe 130 continues to retreat, the increasing grid cell 112 of support is released, sealing unit 106 is also radial with support 110 to be expanded, described sealing unit 106 returns back to initial condition gradually, at this moment doctor can observe the situation of perivalvular leakage by monitoring means, adjusts aortic valve stent position and direction at any time; When after aortic valve stent release completely; described sealing unit 106 is at described support 110 and organize between ring 156; there is good compliance and shape-memory properties simultaneously; automatically can fill up the recess of patient tissue ring 156 and comply with its convex place; and avoid, because of organize the convex place of ring to compress valve bracket distortion that sealing unit causes, protecting form and the function of valve 104 well.
Specific embodiment two:
As shown in figures 6 a and 6b, a kind of aortic valve stent 100 preventing perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is made up of multiple grid cell 112, described artificial valve 104 is connected on described grid cell 112, the bottom of described support 110 is provided with sealing unit 206, described sealing unit 206 is made up and film of metal memory material, in its natural state, described sealing unit 206 outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit 206, for free-end 216, the other end of described sealing unit 206 is fixed by the bottom of fixture and described support 110, for stiff end 226, when described sealing unit 206 is compressed into into sheath pipe, the described free-end 216 of described sealing unit 206 overturns around the bottom of described stiff end 226 to described support, make described sealing unit 206 not overlapping with described support 110.
In a preferred embodiment, the material of described sealing unit 206 is wavy shaped configuration (as shown in Figure 7a) or the zigzag structure (as shown in Figure 8 a) of the nitinol alloy wire coiling of diameter 0.2mm, sawtooth point 266a and 266b of the crest 236a of described wavy shaped configuration and trough 236b or described zigzag structure curves dome-shaped and by inside and outside overlay film 246 (as shown in Figure 7b) respectively to interior, the material of described film 246 is politef, adopts welding, gummed or stitch the mode of tying up to be connected with described sealing unit 206.The independently circular arch shape support bar compared to many, the benefit of such design is to provide the cross-brace power perpendicular to Wave crest and wave trough line, the sealing unit making to be pressed into sheath pipe can better extending transversely when 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 8 b, described fixture 238 is fixing silk, the side of described fixture 238 and the grid cell of described frame bottom are wound around, and the other end of described fixture 238 is fixed on the trough 236 of described wavy shaped configuration or the sawtooth point 266 of described zigzag structure.
As another preferred embodiment, the crest 236a of described wavy shaped configuration and sawtooth point place 266a and 266b of trough 236b or described zigzag structure is turned to annular 256, as shown in Figure 8 c, the free side of described fixture 238 is fixed through described annular 256 and described sealing unit 206, provides more firmly fixed effect.
As illustrated in figures 9 a and 9b, as the preferred embodiment of another kind, mutually be wound around between adjacent bar 237a and 237b of described sealing unit 206, form structure closely, constrain the cross directional stretch distance between support bar 237 on the one hand, larger restoring force is provided, prevent support bar 237 from misplacing when overlay film especially on the other hand, to form evenly fine and closely woven framing structure, greatly improve and prevent perivalvular leakage effect.As the preferred embodiment of another kind, as is shown in fig. 9 c, described fixture 238 is extended to form further by multiple crests 236 of described wavy shaped configuration or multiple sawtooth points 266 of described zigzag structure, and the free side of described fixture 238 and the grid cell 112 of described frame bottom are wound around.
As one preferred embodiment, the described grid cell 112 of described frame bottom arranges some holes 122, as shown in figures 10 a and 10b.The free side of described fixture 238 and the grid cell 112 of described frame bottom are wound around, preferred, and as shown in Figure 10 c-g, the free side of described fixture 238, around being through in described hole 122, reaches the effect of fastening described sealing unit.Described fixture 238 is provided with the bending part 240 through thermal finalization, described bending part 240 is positioned at the stiff end 228 about 4mm place apart from described sealing unit, when described sealing unit 206 again discharges after being compressed into sheath pipe, described sealing unit 206 relies on described bending part 240 to provide elastic-restoring force.Compared to suture, utilize shape-memory properties and the elastic-restoring force of described bending part 240, described sealing unit being made to recover reservation shape when discharging quickly and effectively, more can avoid the caused damage to sealing unit because suture is dawdled, guaranteeing further to prevent perivalvular leakage effect.
Specific embodiment three:
As shown in Figure 11 a and Figure 11 b, a kind of aortic valve stent 100 preventing perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is made up of multiple grid cell 112, described artificial valve 104 is connected on described grid cell 112, the bottom of described support 110 is provided with sealing unit 306, described sealing unit 306 is made up and film of metal memory material, in its natural state, described sealing unit 306 outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit 306, for free-end 316, the other end of described sealing unit 306 is fixed by the bottom of fixture and described support 110, for stiff end 326, when described sealing unit 306 is compressed into into sheath pipe, the described free-end 316 of described sealing unit 306 overturns around the bottom of described stiff end 326 to described support, make described sealing unit 306 not overlapping with described support 110.
As one preferred embodiment, as figure 12 a shows, be provided with in described sealing unit 306 and reply unit 330, one end 331 of described reply unit 330 is connected with described sealing unit 306, and the other end 332 of described reply unit 330 is connected with described support 110.Described reply unit 330 is elastic element.During sheathe, as shown in Figure 12b, after described sealing unit 306 overturns, this reply unit 330 is stretched and is overlapping into sheath with described support 110; When described sealing unit 306 goes out sheath, this reply unit 330 provides pulling force that sealing unit 306 is returned back to original state, realizes preventing perivalvular leakage function.Described reply unit 330 is made into spring shape, waveform or zigzag by shape-memory material or is made up of elastomeric material, and preferably, described shape-memory material is nitinol alloy wire.The two ends of described reply unit 330 adopt weld, glue together, tie around or the seam mode of tying up be connected with described sealing unit 306 and support 110 respectively.
Specific embodiment four:
As shown in Figure 13 a and Figure 13 b, a kind of aortic valve stent 100 preventing perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is made up of multiple grid cell 112, described artificial valve 104 is connected on described grid cell 112, the bottom of described support 110 is provided with sealing unit, described sealing unit is made up and film of metal memory material, in its natural state, described sealing unit outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit, for free-end, the other end of described sealing unit is fixed by the bottom of fixture and described support, for stiff end, when described sealing unit is compressed into into sheath pipe, the described free-end of described sealing unit overturns around the bottom of described stiff end to described support, make described sealing unit not overlapping with described support.Described sealing unit is subdivided into 9 junior unit 407 (407a, 407b, 407c......), each unit 407 all has domes, described junior unit 407 distributes along the external circumferential of described support 110, one end dissociative of described junior unit 407 is free-end 417, and the other end is fixed as stiff end 427 by the bottom of fixture and described support 110.Such design decreases the traction of sealing unit by overlay film, be conducive to described sealing unit to overturn when sheathe, restore to the original state rapidly when discharging, and fill up the recess of patient tissue ring upon discharge independently, comply with the protrusion place of patient tissue ring, degree of freedom is larger, prevents perivalvular leakage effect better.As one preferred embodiment, as shown in figure 13 c, described fixture 438 is rivet, and the hole 122 through described frame bottom realizes fixing.As another preferred embodiment, as shown in figure 13d, described fixture 438 is by the trough of the wavy shaped configuration of described sealing unit, or the sawtooth point of described zigzag structure extends to form further, grid cell 112 bottom the free side of described fixture 438 and described support 110 is fastened, the free side of described fixture 438 is around being through in described hole 122a and 122b, and described fixture 438 is once engage solid and reliable with described support 110 after shape sizing.
As another preferred embodiment, as shown in figures 14a, the stiff end 428 of described junior unit 407 leaves a segment distance with the bottom of described support 110, described fixture 438 is provided with the bending part 440 through thermal finalization, described bending part 440 is between the stiff end 428 and described frame bottom of described junior unit 407, apart from the stiff end 428 about 3mm of described junior unit 407, described bending part 440 is apart from described frame bottom 3mm, such design makes deformation point be placed on described fixture 438, when described junior unit 407 again discharges after being compressed into sheath pipe, described junior unit 407 relies on described bending part 440 to provide elastic-restoring force, especially more remarkable when described fixture 438 is the thick line after winding mutually.Described bending part 440 is unsuitable oversize with the distance of described frame bottom, otherwise excessively upset after easily causing described junior unit 407 to press sheath to discharge, as shown in fig. 14b.
As another preferred embodiment, as shown in figure 15, apart from the length bottom described support 110 not etc., such being designed with can not be overlapped between junior unit when helping sheathe for adjacent described bending part 440.
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 done within the spirit and principles in the present invention, equivalent replacement and improvement etc., all should be included within protection scope of the present invention.
Claims (17)
1. one kind prevents the aortic valve stent of perivalvular leakage, comprise support and artificial valve, described support is made up of multiple grid cell, described artificial valve is connected on described grid cell, it is characterized in that, the bottom of described support is provided with sealing unit, described sealing unit is made up and film of metal memory material, in its natural state, described sealing unit outwards arches upward along the axis of described support, circumference along described support is loop configuration, one end dissociative of described sealing unit, for free-end, the other end of described sealing unit is fixed by the bottom of fixture and described support, for stiff end, when described sealing unit is compressed into into sheath pipe, the described free-end of described sealing unit overturns around the bottom of described stiff end to described support, make described sealing unit not overlapping with described support.
2. the aortic valve stent preventing perivalvular leakage according to claim 1, it is characterized in that, described sealing unit is subdivided into multiple junior unit, 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 the bottom of fixture and described support.
3. the aortic valve stent preventing perivalvular leakage 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 described support bar is fixed by the bottom of described fixture and described support.
4. the aortic valve stent preventing perivalvular leakage according to claim 3, it is characterized in that, described fixture is extended to form by one end of described support bar, and the free side of described fixture and the grid cell of described frame bottom are wound around with fixing described sealing unit.
5. the aortic valve stent preventing perivalvular leakage according to claim 4, is characterized in that, the described grid cell of described frame bottom arranges some holes, and the described free side of described fixture is passed or the fastening described sealing unit in hole described in grappling.
6. the aortic valve stent preventing perivalvular leakage according to claim 1 and 2, it is characterized in that, described sealing unit is wavy shaped configuration or the zigzag structure of metal memory material filament winding system, and the sawtooth point of the crest of described wavy shaped configuration and trough or described zigzag structure overarches respectively to inflection.
7. the aortic valve stent preventing perivalvular leakage according to claim 6, is characterized in that, the diameter of described metal memory material silk is in the scope of 0.01-0.3mm.
8. the aortic valve stent preventing perivalvular leakage according to claim 6, 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.
9. the aortic valve stent preventing perivalvular leakage according to claim 6, is characterized in that, is mutually wound around between the adjacent bar of described sealing unit.
10. the aortic valve stent preventing perivalvular leakage according to claim 6, it is characterized in that, described fixture is fixing silk, the side of described fixture and the grid cell of described frame bottom 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.
11. aortic valve stent preventing perivalvular leakage according to claim 6, it is characterized in that, described fixture is by multiple crest of described wavy shaped configuration or trough, or multiple sawtooth points of described zigzag structure extend to form further, the free side of described fixture and the grid cell of described frame bottom are wound around.
12. aortic valve stent preventing perivalvular leakage according to claim 10 or 11, is characterized in that, the described grid cell of described frame bottom arranges some holes, and described fixture is through the fastening described sealing unit in described hole.
13. aortic valve stent preventing perivalvular leakage according to any one of claim 1,2,4,5,7,8,9,10 or 11, it is characterized in that, described fixture is provided with the bending part through thermal finalization, and described bending part is apart from the described stiff end 0 ~ 8mm of described sealing unit.
14. aortic valve stent preventing perivalvular leakage according to claim 13, is characterized in that, adjacent described bending part apart from described frame bottom length not etc.
15. aortic valve stent preventing perivalvular leakage according to claim 1, it is characterized in that, described film adopts welding, gummed or stitches the mode of tying up and is connected with described sealing unit, and the material of described film comprises politef, polyethylene, polypropylene, terylene or animal derived material.
16. aortic valve stent preventing perivalvular leakage according to claim 1, it is characterized in that, reply unit is provided with in described sealing unit, one end of described reply unit is connected with described sealing unit, the other end of described reply unit is connected with described support, and described reply unit is elastic element.
17. aortic valve stent preventing perivalvular leakage according to claim 16, is characterized in that, described reply unit is by shape-memory material wound into spring shape, waveform or zigzag, or described reply unit is made up of elastomeric material.
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| WO2019050776A1 (en) * | 2017-09-06 | 2019-03-14 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
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| US9668858B2 (en) | 2014-05-16 | 2017-06-06 | St. Jude Medical, Cardiology Division, Inc. | Transcatheter valve with paravalvular leak sealing ring |
| CN104274259B (en) * | 2014-10-30 | 2016-06-01 | 宁波健世生物科技有限公司 | The artificial valve prosthese of a kind of band lobe leaf clamping device |
| US9693860B2 (en) * | 2014-12-01 | 2017-07-04 | Medtronic, Inc. | Segmented transcatheter valve prosthesis having an unsupported valve segment |
| US10080652B2 (en) * | 2015-03-13 | 2018-09-25 | Boston Scientific Scimed, Inc. | Prosthetic heart valve having an improved tubular seal |
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| EP3429509A1 (en) * | 2016-03-14 | 2019-01-23 | Medtronic Vascular Inc. | Stented prosthetic heart valve having a wrap and delivery devices |
| KR102644828B1 (en) * | 2017-05-30 | 2024-03-08 | 에보닉 캐나다 인크. | Prosthetic valve with modified surface |
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| WO2019042472A1 (en) * | 2017-09-04 | 2019-03-07 | 杭州启明医疗器械有限公司 | Easy-mounting stent device for peripheral leakage prevention and processing method thereof, skirt folding method, and heart valve |
| CN108378959A (en) * | 2018-02-11 | 2018-08-10 | 四川中盾知识产权服务有限公司 | A kind of heart valve forming ring with bridge layer |
| CN109498215B (en) * | 2018-12-14 | 2023-05-02 | 宁波健世科技股份有限公司 | Separated release aortic valve stent |
| CN114762634A (en) * | 2021-01-14 | 2022-07-19 | 南京圣德医疗科技有限公司 | Balloon expansion type intervention valve stent with folding wingspan skirt edge |
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| WO2019050776A1 (en) * | 2017-09-06 | 2019-03-14 | Edwards Lifesciences Corporation | Sealing member for prosthetic heart valve |
| CN111050701A (en) * | 2017-09-06 | 2020-04-21 | 爱德华兹生命科学公司 | Sealing member for prosthetic heart valve |
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