CN103705315A - Aortic valve stent capable of preventing perivalvular leakage - Google Patents
Aortic valve stent capable of preventing perivalvular leakage Download PDFInfo
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- CN103705315A CN103705315A CN201310671694.7A CN201310671694A CN103705315A CN 103705315 A CN103705315 A CN 103705315A CN 201310671694 A CN201310671694 A CN 201310671694A CN 103705315 A CN103705315 A CN 103705315A
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- valve stent
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Images
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
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- 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
The invention discloses an aortic valve stent (100) capable of preventing perivalvular leakage. The aortic valve stent (100) capable of preventing perivalvular leakage comprises a stent (110) and an artificial valve (104), wherein the stent (110) is composed of a plurality of grid cells (112); the artificial valve (104) is connected to the grid cells (112); a sealing unit (106) is arranged at the bottom of the stent (110); the sealing unit (106) is made from a metal memory material and laminated; in a natural state, the sealing unit (106) is arched outwards along the axial direction of the stent and of an annular structure along the peripheral direction of the stent (110); one end of the sealing unit (106) is free and is a free end (116); the other end of the sealing unit (106) is fixed with the bottom of the stent (110) by a fixing element, and is a fixed end (126); when the sealing unit (106) is compressed to enter a sheathing canal, the free end (116) of the sealing unit (106) turns towards the bottom end of the stent and around the fixed end (126), thus the sealing unit (106) is not superposed with the stent (110).
Description
Technical field:
The invention belongs to medical instruments field, be specifically related to a kind of aortic valve stent that prevents perivalvular leakage.
Background technology:
Aortic stenosis is the common valvular heart disease of old people, and 75-85 year patient's sickness rate is about 4%, and the age surpasses the patient of 85 years old and is increased to 7% left and right.Wherein because the aortic stenosis incidence rate due to calcific aortic valve reaches 2%-7%, and with advancing age, its ratio increases all the more, one of major reason that has become Aged Heart Failure, arrhythmia, faints and died suddenly.The first-elected surgery valve replacement of traditional Therapeutic Method, but for advanced age, Lower cardiac function or and have the patient of multiple complications mortality rate be very high, conservative Drug therapy and two kinds of therapeutic modalities of balloon expandable are not good after more in addition, complication and relapse rate are high.
Since 2002, Cribier etc. take the lead in having reported first case human body percutaneous aortic valve replacement art example, making to become the numerous another kind treatments that cannot accept the patient of surgical intervention through conduit aortic valve replacement (Transcatheter Aortic Valve Implantation, TAVI) selects.For many years, TAVI is flourish, and all kinds of apparatuses and technology are developed in succession, TAVI is become be not suitable for the high-risk group's of traditional surgery first-selection.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 adopting at present, 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 is told us, although the middle late result 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 that as one of severe complication each side payes attention to, many parts large-scale clinical test results demonstrations, perivalvular leakage almost sees the patient after all TAVI, wherein, in, severe perivalvular leakage sees the postoperative patient of 20% left and right, greatly affected more after quality of life.Meanwhile, blood vessel injury etc. also appear in the newspapers repeatly, cause retroperitoneal hematoma, artery dissection, false aneurysm to form, and jeopardize patient's survival rate.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, when the gap of patient's calcification valve is originally irregular or do not close 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 affect the treatment.
In patent CN201120022195, propose a kind of with the fixing ascending aorta inner cavity insulation support of capsule of filled-type, fixedly 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 adopting is not enough, can not automatically fill up the recess of irregular tissue ring, and tissue ring protuberance can be oppressed 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.When 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 guaranteed, tissue ring recess will have perivalvular leakage and occur; When 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, the part sealing unit in existing design can cause sheathe difficulty, increases sheath pipe diameter, after use, may cause serious vascular complication; Four, water swellability material is used for preventing may having uncontrollable expansion rate and risk of leakage on perivalvular leakage.For above problem, the present invention proposes a kind of aortic valve stent that can conscientiously 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 and a kind ofly can conscientiously 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, can automatically fill up the recess of patient tissue ring and comply with its protruding place.The means that are connected that described sealing unit adopts with Support frame have effectively been avoided compressing because of the protruding place of tissue ring the valve bracket distortion that sealing unit causes; valve form and function have been protected well; and can to the bottom of support, overturn around described stiff end at the described free-end of sealing unit described in sheathe process; therefore can not expand sheathe diameter; significantly reduce the stimulation to patient vessel, reduced vascular complication risk.
The object of the invention is to be achieved through the following technical solutions:
A kind of aortic valve stent that prevents perivalvular leakage, comprise support and artificial valve, described support is comprised of a plurality of grid cells, described artificial valve is connected on described grid cell, bottom at described support is provided with sealing unit, described sealing unit is made by 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 the bottom of fixture and described support, for stiff end, when described sealing unit is compressed while entering sheath pipe, the described free-end of described sealing unit is the bottom upset to described support around described stiff end, make described sealing unit not overlapping with described support.
Object of the present invention can also further realize by following technical scheme:
Preferably, described sealing unit is subdivided into a plurality of junior units, 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 comprised 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 to fix described sealing unit.
Preferred, on the described grid cell of described frame bottom, some holes are set, the described free side of described fixture through or grappling described in the fastening described sealing unit in hole.
Preferably, described sealing unit is wavy shaped configuration or the zigzag structure that metal memory material filament winding system forms, and the sawtooth point of the crest of described wavy shaped configuration and trough or described zigzag structure inwardly curves respectively arch.
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, so that described sealing unit is securely fixed on described support.
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.
Preferred, described fixture is fixing silk, and a 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 a plurality of crests or the trough of described wavy shaped configuration, or a plurality of sawtooth points of described zigzag structure further extend to form, and the free side of described fixture and the grid cell of described frame bottom are wound around.
Preferred, on the described grid cell of described frame bottom, some holes are set, described fixture is through the fastening described sealing unit in described hole.
Preferred, on described fixture, be provided with the bending part through thermal finalization, the described stiff end 0～8mm of the described sealing unit of described bending part distance.
Preferred, the length of the described frame bottom of adjacent described bending part distance is not etc.
Preferably, the mode that described film adopts welding, gummed or seam to tie up 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; Described sealing unit goes out after sheath, and the pulling force that this reply unit provides returns back to original state by described sealing unit, to realize the function that prevents perivalvular leakage.
Preferred, described reply unit is by shape-memory material wound into spring shape, waveform or zigzag, or described reply unit is made by elastomeric material.Most preferred, described shape-memory material is nitinol alloy wire.
Preferred, the two ends of described reply unit adopt welding, gummed, tie around or stitch the mode of tying up and are connected with described support with described sealing unit 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, the sealing unit in the aortic valve stent that prevents perivalvular leakage of the present invention 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, one end dissociative of the sealing unit in the present invention (free-end), the other end (stiff end) is fixed with frame bottom, in pressing sheath process, the free-end of sealing unit can overturn and extend axially along support to the bottom of support around its stiff end, sealing unit is not overlapping with Support frame, reduce sheathe diameter, significantly reduced the stimulation to patient vessel, reduced vascular complication risk;
3, the means that are connected that sealing unit of the present invention adopts with support have effectively been avoided, because the protruding place of tissue ring compresses the valve bracket distortion that sealing unit causes, having protected well form and the function of valve.
Accompanying drawing explanation
Fig. 1 shows the schematic diagram that prevents 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 show the sheathe schematic diagram of the aortic valve stent that prevents perivalvular leakage.
Fig. 5 shows the release schematic diagram of the aortic valve stent that prevents perivalvular leakage, wherein Fig. 5 a and Fig. 5 b show the aortic valve stent dispose procedure gradually that prevents perivalvular leakage, Fig. 5 c shows and prevents that the aortic valve stent of perivalvular leakage is positioned at patient tissue ring place, and Fig. 5 d shows and prevents that the aortic valve stent of perivalvular leakage is positioned at the top view at patient tissue ring place.
Fig. 6 a and 6b show the schematic diagram that prevents the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention.
Fig. 7 a and 7b show the structural representation of sealing unit in preferred embodiment of the present invention.
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 is extended the schematic diagram of a plurality of extensions, and Fig. 8 c is the local enlarged diagram of Fig. 8 b.
Fig. 9 a and 9b show the structural representation of sealing unit in another preferred embodiment of the present invention, Fig. 9 c shows a plurality of crests or the trough of a wavy shaped configuration described in preferred embodiment, or a plurality of sawtooth points of described zigzag structure further extend to form the schematic diagram of extension.
Figure 10 a and 10b show the carved pattern of a preferred embodiment medium-height trestle of the present invention, 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 show the schematic diagram that prevents the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention.
Figure 12 a and Figure 12 b show the schematic diagram of replying unit.
Figure 13 a and Figure 13 b show the schematic diagram that prevents the aortic valve stent of perivalvular leakage in another preferred embodiment of the present invention, and Figure 13 c and Figure 13 d show the fixed form schematic diagram of junior unit and support.
Figure 14 a and Figure 14 b show 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.
The specific embodiment:
For making object of the present invention, technical scheme and advantage clearer, referring to the accompanying drawing embodiment that develops simultaneously, the present invention is described in more detail.
Near-end of the present invention 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 and Fig. 1 b, a kind of aortic valve stent 100 that prevents perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is comprised of a plurality of grid cells 112, described artificial valve 104 is connected on described grid cell 112, in the bottom of described support 110, be provided with sealing unit 106, described sealing unit 106 is made by 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 fixed by the bottom of fixture and described support 110, for stiff end 126, when described sealing unit 106 is compressed while entering sheath pipe, the described free-end 116 of described sealing unit 106 is the bottom upset to described support around described stiff end 126, 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 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 preferred embodiment a kind of, 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, 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 fixed by described fixture 138 and the bottom of described support.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 to fix described sealing unit.As another preferred embodiment, as shown in Figure 3 a, on the grid cell 112 of described frame bottom, single hole 118 is set, thus the fixing described sealing unit 106 in the fixed described hole 118 of the free side anchor of described fixture 138.On described fixture 138, be provided with the bending part 140 through thermal finalization, described bending part 140 is positioned at the about 3mm of stiff end 128 place of the described sealing unit of distance, when described sealing unit 106 is compressed while again discharging after entering sheath pipe, described sealing unit 106 relies on described bending part 140 that elastic-restoring force is provided, 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 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 the grid cell of described frame bottom, as shown in Fig. 3 c and 3d, to further improving the fixed effect of described fixture 138.
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 is along axially bottom (far-end) upset to support around described stiff end 126 of support, not overlapping with described support 110 at the interior described sealing unit 106 of sheath pipe 130, thus reach the object that reduces sheathe diameter.While being loaded with the sheath pipe 130 arrival target location of described aortic valve stent, sheath pipe 130 retreats, and progressively discharges aortic valve stent 100.As shown in Fig. 5 a-d, the release initial stage, support is not replied original shape 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, extended state during from pressure sheath is replied as circular arch state, at this moment capable of regulating aortic valve stent 100 positions, allow described sealing unit 106 be positioned on tissue ring 156; 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 the situation of perivalvular leakage by monitoring means, adjusts at any time aortic valve stent position and direction; 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. 6 a and Fig. 6 b, a kind of aortic valve stent 100 that prevents perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is comprised of a plurality of grid cells 112, described artificial valve 104 is connected on described grid cell 112, in the bottom of described support 110, be provided with sealing unit 206, described sealing unit 206 is made by 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 fixed by the bottom of fixture and described support 110, for stiff end 226, when described sealing unit 206 is compressed while entering sheath pipe, the described free-end 216 of described sealing unit 206 is the bottom upset to described support around described stiff end 226, 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) that the nitinol alloy wire coiling of diameter 0.2mm forms, the crest 236a of described wavy shaped configuration and the sawtooth of trough 236b or described zigzag structure point 266a and 266b inwardly curves respectively dome-shaped and by inside and outside overlay film 246 (as shown in Figure 7b), 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 when discharging, fill up more vacancy, avoid sealing unit to be extruded agglomerating, impact prevents perivalvular leakage function.
As preferred embodiment a kind of, as shown in Figure 8 b, described fixture 238 is fixing silk, one 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 described trough 236 of 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 the sawtooth of trough 236b or the described zigzag structure point 266a of place and 266b are turned to annular 256, as shown in Figure 8 c, 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 shown in Fig. 9 a and 9b, as the preferred embodiment of another kind, between the adjacent bar 237a of described sealing unit 206 and 237b, be mutually wound around, form structure closely, retrained the cross directional stretch distance between support bar 237 on the one hand, larger restoring force is provided, prevented especially that on the other hand support bar 237 from misplacing in overlay film, 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 238 is further extended to form by a plurality of crests 236 of described wavy shaped configuration or a plurality of sawtooth points 266 of described zigzag structure, and the free side of described fixture 238 and the grid cell of described frame bottom 112 are wound around.
As preferred embodiment a kind of, some holes 122 are set on the described grid cell 112 of described frame bottom, as shown in Figure 10 a and 10b.The free side of described fixture 238 and the grid cell of described frame bottom 112 are wound around, preferred, and as shown in Figure 10 c-g, the free side of described fixture 238, in being through described hole 122, reaches the effect of fastening described sealing unit.On described fixture 238, be provided with the bending part 240 through thermal finalization, described bending part 240 is positioned at the about 4mm of stiff end 228 place of the described sealing unit of distance, when described sealing unit 206 is compressed while again discharging after entering sheath pipe, described sealing unit 206 relies on described bending part 240 that elastic-restoring force is provided.Than suture, utilize shape-memory properties and the elastic-restoring force of described bending part 240, can make described sealing unit when discharging, recover reservation shape quickly and effectively, more can avoid the caused damage to sealing unit because suture is dawdled, further guarantee 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 that prevents perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is comprised of a plurality of grid cells 112, described artificial valve 104 is connected on described grid cell 112, in the bottom of described support 110, be provided with sealing unit 306, described sealing unit 306 is made by metal memory material and by overlay film, under naturalness, described sealing unit 306 axially outwards arching upward along described support, along described support is circumferentially 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 while entering sheath pipe, the described free-end 316 of described sealing unit 306 is the bottom upset to described support around described stiff end 326, make described sealing unit 306 not overlapping with described support 110.
As preferred embodiment a kind of, as shown in Figure 12 a, in described sealing unit 306, be provided with 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 12 b, after described sealing unit 306 upsets, 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 and prevents perivalvular leakage function.Described reply unit 330 is made into spring shape, waveform or zigzag or is made by elastomeric material by shape-memory material, and preferred, described shape-memory material is nitinol alloy wire.The two ends of described reply unit 330 adopt welding, gummed, tie around or stitch the mode of tying up and are connected with support 110 with described sealing unit 306 respectively.
Specific embodiment four:
As shown in Figure 13 a and Figure 13 b, a kind of aortic valve stent 100 that prevents perivalvular leakage, comprise support 110 and artificial valve 104, described support 110 is comprised of a plurality of grid cells 112, described artificial valve 104 is connected on described grid cell 112, bottom at described support 110 is provided with sealing unit, described sealing unit is made by 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 the bottom of fixture and described support, for stiff end, when described sealing unit is compressed while entering sheath pipe, the described free-end of described sealing unit is the bottom upset to described support around described stiff end, 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.Design has reduced the traction that sealing unit is subject to overlay film like this, be conducive to described sealing unit overturns when sheathe, when 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 preferred embodiment a kind of, as shown in Figure 13 c, described fixture 438 is rivet, through the hole 122 of described frame bottom, realizes fixing.As another preferred embodiment, as shown in Figure 13 d, described fixture 438 is by the trough of the wavy shaped configuration of described sealing unit, or the sawtooth point of described zigzag structure further extends to form, the grid cell 112 of the free side of described fixture 438 and described support 110 bottoms is fastened, the free side of described fixture 438 is in being through described hole 122a and 122b, once engage solid and reliable with described support 110 after the 438 shape sizings of described fixture.
As another preferred embodiment, as shown in Figure 14 a, the stiff end 428 of described junior unit 407 leaves a segment distance with the bottom of described support 110, on described fixture 438, be provided with the bending part 440 through thermal finalization, described bending part 440 is between the stiff end 428 of described junior unit 407 and described frame bottom, the about 3mm of stiff end 428 of the described junior unit 407 of distance, the described frame bottom 3mm of described bending part 440 distance, such design is placed on described fixture 438 deformation point, when described junior unit 407 is compressed while again discharging after entering sheath pipe, described junior unit 407 relies on described bending part 440 that elastic-restoring force is provided, especially more remarkable during the thick line after described fixture 438 is to be mutually wound around.Described bending part 440 is unsuitable oversize with the distance of described frame bottom, otherwise easily cause described junior unit 407 press sheaths to discharge after excessively upset, as shown in Figure 14 b.
As another preferred embodiment, as shown in figure 15, not etc., such being designed with can be not overlapped between junior unit while helping sheathe for the length of support 110 bottoms that adjacent described bending part 440 distances are described.
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 modifications 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 (17)
1. an aortic valve stent that prevents perivalvular leakage, comprise support and artificial valve, described support is comprised of a plurality of grid cells, described artificial valve is connected on described grid cell, it is characterized in that, bottom at described support is provided with sealing unit, described sealing unit is made by 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 the bottom of fixture and described support, for stiff end, when described sealing unit is compressed while entering sheath pipe, the described free-end of described sealing unit is the bottom upset to described support around described stiff end, make described sealing unit not overlapping with described support.
2. the aortic valve stent that prevents perivalvular leakage according to claim 1, it is characterized in that, described sealing unit is subdivided into a plurality of 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 the bottom of fixture and described support.
3. the aortic valve stent that prevents perivalvular leakage according to claim 1 and 2, it is characterized in that, described sealing unit is comprised 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 that prevents 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 to fix described sealing unit.
5. the aortic valve stent that prevents perivalvular leakage according to claim 4, is characterized in that, on the described grid cell of described frame bottom, some holes is set, the described free side of described fixture through or grappling described in the fastening described sealing unit in hole.
6. the aortic valve stent that prevents perivalvular leakage 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, and the sawtooth point of the crest of described wavy shaped configuration and trough or described zigzag structure inwardly curves respectively arch.
7. the aortic valve stent that prevents 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 that prevents 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 that prevents perivalvular leakage according to claim 6, is characterized in that, between the adjacent bar of described sealing unit, is mutually wound around.
10. the aortic valve stent that prevents perivalvular leakage according to claim 6, it is characterized in that, described fixture is fixing silk, one 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 that prevent perivalvular leakage according to claim 6, it is characterized in that, described fixture is by a plurality of crests or the trough of described wavy shaped configuration, or a plurality of sawtooth points of described zigzag structure further extend to form, the free side of described fixture and the grid cell of described frame bottom are wound around.
12. according to the aortic valve stent that prevents perivalvular leakage described in claim 10 or 11, it is characterized in that, on the described grid cell of described frame bottom, some holes is set, and described fixture is through the fastening described sealing unit in described hole.
13. according to the aortic valve stent that prevents perivalvular leakage described in any one in claim 1,2,4,5,7,8,9,10 or 11, it is characterized in that, on described fixture, be provided with the bending part through thermal finalization, the described stiff end 0～8mm of the described sealing unit of described bending part distance.
14. aortic valve stent that prevent perivalvular leakage according to claim 13, is characterized in that, the length of the described frame bottom of adjacent described bending part distance is not etc.
15. aortic valve stent that prevent perivalvular leakage according to claim 1, it is characterized in that, the mode that described film adopts welding, gummed or seam to tie up is connected with described sealing unit, and described membrane material comprises politef, polyethylene, polypropylene, terylene or animal derived material.
16. aortic valve stent that prevent perivalvular leakage according to claim 1, it is characterized in that, in described sealing unit, be provided with reply 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 that prevent 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 by elastomeric material.
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