CN107811728A - Vascular endoprostheses - Google Patents
Vascular endoprostheses Download PDFInfo
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- CN107811728A CN107811728A CN201710959607.6A CN201710959607A CN107811728A CN 107811728 A CN107811728 A CN 107811728A CN 201710959607 A CN201710959607 A CN 201710959607A CN 107811728 A CN107811728 A CN 107811728A
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Classifications
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
Abstract
The invention discloses a kind of vascular endoprostheses, and specifically, the vascular endoprostheses include i layer tubular blood vessel supports, wherein, 2≤i≤8, for treating dissection of aorta and aneurysm lesion, particularly Ascending Aortic Aneurysm interlayer；Tubular blood vessel support is divided into close net braided support and thin net braided support, and the mesh density of close net braided support is larger, and the mesh density for dredging net braided support is smaller；The quantity of close net braided support is m, wherein, 1≤m≤4；The quantity for dredging net braided support is n, wherein, 1≤n≤4；And i=m+n；Close net braided support and thin net braided support are circumferentially coaxially stacked, for cooperateing with support blood vessels, and the mutually axial elongation of limit bracket or cripetura deformation.The present invention can be effectively by support Surgery dissection of aorta, and the dissection of aorta or aneurysm of PCI can not be carried out by particularly treating current clinic.
Description
Technical field
The present invention relates to medical instruments field, relates more specifically to a kind of vascular endoprostheses.
Background technology
Human Thoracic Aortic Dissection is not true aneurysm, nor false aneurysm, but because a variety of causes causes intra-arterial
Film and the damage in middle level, endarterium of the blood along tear in aorta lumen, into aortic tunica media, blood is formed in middle level
It is swollen, make middle film tear separation, it is two layers that aorta wall, which is peeled off, and under the impact of blood flow, released part is gradually near to sustainer
Heart end and distal end extension expansion, form aortic flow vacation chamber.The middle level separation property expansion of different range is formed, is referred to as actively
Arteries and veins interlayer or dissection of aorta separation.
Dissection of aorta is a kind of common specific type aneurysm of thoracic aorta, and the cause of disease for causing dissection of aorta is mainly：
High blood pressure and artery sclerosis, CTD and marfan's syndrome, congenital stenosis of aortic valve, bicuspid aortic valve deformity
With Congenital Coarctation of Aorta etc..The harm of dissection of aorta is that false chamber becomes not timing bomb, false chamber once being formed
Rupture or the aneurysm rupture formed easily cause massive haemorrhage, have interrupted the supply of blood flow of sustainer important branch, have caused important dirty
The severe ischemic function of device is lost, and causes severe complication and death.
The aorta ascendens that Human Thoracic Aortic Dissection most often originates in above aorta petal, it is secondly aortic isthmus, but also may be used
Occur at other of the arch of aorta and sustainer position.According to pathological anatomy and the scope of lesion, DeBakey is by dissection of aorta
It is divided into three types.
I type：Aorta wall peels off position and originates in root of ascending aorta, and it is near that the cut of inner membrance typically originates in aorta ascendens
Antetheca is held, descending aorta is extended to distal aorta, but can also originate in the arch of aorta even in descending thoracic aorta, drives in the wrong direction and divides
From to aortic root and to remaining position for distally involving sustainer.These patients have often because aortic valvular ring expansion or
Interlayer lesion proximally stretches, and causes valve to lose support, causes aortic incompetence.
II type：The position that aorta wall is peeled off is confined to aorta ascendens.The characteristics of common is inner membrance antetheca on aorta petal
There is a cleft face, the general proximal part for terminating in innominate artery initial part of interlayer separation, can also involve aortic arch sometimes.It is this kind of
It is incomplete that patient is also often associated with aorta petal pass.
III type：Aorta wall peels off the distal end for originating in left subclavian artery opening, and extends to one to distal aorta
Determine scope.Such as the lesion person that is confined to thoracic descending aorta, claim III a types；But most patient's interlayer lesions are extended under diaphram, are involved
Abdominal aorta, or even common iliac artery, claim III b types.
Human Thoracic Aortic Dissection can be divided into acute and chronic two class, acute interlayer refers to that artery dissection is sent out according to the onset time
Life is within 2 weeks, and morbidity is referred to as chronic arterial interlayer after 2 weeks, and both clinical manifestations and prognosis make a big difference.Acute master
Artery dissection 48h internal causes aneurysm rupture or acute cardiac tamponade etc., case fatality rate are up to case fatality rate in 36%~72%, 2 week
57%~89%.And in chronic phase, substantially reduced because rupture causes the dead, but the patient for having 90% in onset half a year dies from artery clamp
Layer rupture.
The most common and most important symptom of acute thoracic aortic dissection is unexpected tear sample severe pain, and patient has dying more
Feel.The pain position of A type interlayers is in radioactivity after breastbone；The pain position of Type B interlayer is in chest and back.According to interlayer
The scope of stripping, its painful area can be extended to belly, lower abdomen etc..Some patients because of the acute closing of concurrent aorta petal not
Entirely, acute left ventricular failure can be shown.Other symptoms have syncope, expiratory dyspnea etc..And when complicated with acute ruptures, patient will be
It is dead in several minutes.
At present, the descending aorta interlayer for DeBakey type IIIs has had been developed that various self-expanding overlay films
Support carries out PCI, and achieves good effect.Its general principle is to be loaded in delivery system after overlay film frame is compressed
On system, discharged after being delivered to vascular lesion position from the femoral artery or common iliac artery of distal end, using the self-expanding characteristic of support itself,
Support is opened in Endovascular and is close to sustainer inwall, and the overlay film of rack surface carries out isolation envelope to aneurysm or interlayer
Close.So as to reach the purpose for the treatment of.The technology has been used widely at present.
But these products are only applicable only to descending thoracic aorta, and require that stent anchors area is not less than 15mm.Such as chest master
Artery requires knurl body or interlayer cut apart from left subclavian artery at least 15-20mm spacing.Involve for interlayer or aneurysm
The patient of aorta ascendens, because aorta ascendens is relatively short relatively thick, and the coronary ostium of the oriented heart blood supply of proximal part, far
The oriented brain in heart end is truncus brachiocephalicus arterial ostium, left common carotid artery and the left subclavian artery of right upper extremity blood supply, its physiology and appearance
Structure limits application of the existing overlay film frame in aorta dissection treatment, and support is difficult in aorta ascendens Endovascular
Realize stable grappling.Once support migration leaks in occurring, cause operative failure.Ripe available intervention there is no to control at present
Treatment technology, conventional open chest surgery can only be used to carry out artificial vessel replacement.
To solve the above problems, CN201120022195.1 patents are moved it is proposed that reaching anchor supports by filling knurl neck
Plant, prevent from causing because of Endovascular isolation implant loose shift leakage or the generation of aneurysm rupture in blood.The patent
The new approaches of grappling are proposed, but anchor can not be produced to stent graft at once by filling knurl neck anchor supports graft
It is fixed, and anchoring strength depends on the physiological structure of knurl neck, anchoring strength and limited efficacy.CN201480041652.8 patents disclose
A kind of multicompartment support implanting body system, the aneurysm of aorta ascendens or artery to treat are peeled off.Branch is placed on a liter active
Arteries and veins, aortic sinus and arteria coroaria sinistra and arteria coronaria dextra.By the way that branch stent is inserted into left and right coronary artery, for a liter active
Pulsation frame provides grappling.Although certain grappling or so can be had altogether by left and right coronary artery, due to left and right coronary artery
Undersized, diameter only has 4~6mm, and branch stent can not be long, and aorta ascendens diameter has reached more than 40mm, therefore
The problem of anchoring effect deficiency still be present.
Therefore, clinically it is badly in need of developing a kind of new Endoluminal repair thing to solve this problem.
The content of the invention
It is an object of the invention to provide a kind of vascular endoprostheses, the vascular endoprostheses are by multiple different counts
Braided support combines, for treating dissection of aorta and aneurysm, particularly aorta ascendens and arch of aorta interlayer, and
Abdominal aorta interlayer.
The invention provides a kind of vascular endoprostheses, and specifically, the vascular endoprostheses include i layer tubular blood vessel supports, its
In, 2≤i≤8, for treating dissection of aorta and aneurysm lesion, particularly Ascending Aortic Aneurysm interlayer and abdominal aneurvsm folder
Layer；The tubular blood vessel support is divided into close net braided support and thin net braided support, the mesh density of the close net braided support
Larger, the mesh density of the thin net braided support is smaller；The quantity of the close net braided support is m, wherein, 1≤m≤4；Institute
The quantity for stating thin net braided support is n, wherein, 1≤n≤4；And i=m+n；The close net braided support and the thin net braiding
Support is circumferentially coaxially stacked, and for cooperateing with support blood vessels, and mutually limits axial elongation or the cripetura of the support
Deformation.
In another preference, the vascular endoprostheses include internal layer and outer layer, wherein, the outer layer is compiled for the thin net
Support is knitted, the internal layer is the close net braided support, and the mesh density of the braided support increases successively from outer layer to internal layer,
Wherein 1≤m≤4,1≤n≤2；And the both ends of the close net braided support are designed for enlarging, 5-30 ° of flaring angle, enlarging length
For 5-30mm, to be closely attached on the thin net braided support of outer layer.
Preferably, the angle of weave of close net braided support, which is not equal to, dredges net braided support, and two layers mutually adjacent of support
Angle of weave be not mutually equal.
In another preference, the angle of weave of two layers adjacent of support differs at least more than 5 °, it is preferable that and 15-60 °,
Smaller mesh is produced so that adjacent weave mesh is overlapped mutually, realizes and sealing process is effectively completely cut off to false chamber blood flow.
Preferably, the mesh knitted angle of tubular blood vessel support is gradually reduced from outer layer to internal layer, the thin net braiding of outer layer
The angle of weave of support is larger, realizes effective support to the true chamber of blood vessel, and the angle of weave of the close net braided support of internal layer is smaller,
To realize more head number braidings.
In another preference, the vascular endoprostheses include outer layer, internal layer and intermediate layer, wherein, the intermediate layer is
The close net braided support, the outer layer and the internal layer are to dredge net braided support, from the intermediate layer to the outer layer or to
The internal layer, the mesh density of the braided support are successively successively decreased, and the mesh density in the intermediate layer is maximum；The intermediate layer
Quantity is 1-3 layers, and the quantity of the outer layer and the internal layer is 1-2 layers.
Preferably, the angle of weave of close net braided support, which is not equal to, dredges net braided support, and the volume of two layers adjacent of support
Angle is knitted to be not mutually equal.
In another preference, the angle of weave of two layers adjacent of support differs at least more than 5 °, it is preferable that and 15-60 °,
Smaller mesh is produced so that adjacent weave mesh is overlapped mutually, realizes and sealing process is effectively completely cut off to false chamber blood flow.
In another preference, the vascular endoprostheses include internal layer and outer layer, wherein, the outer layer is compiled for the close net
Support is knitted, the internal layer is the thin net braided support, and the mesh density of the braided support is sequentially reduced from outer layer to internal layer,
Wherein 1≤m≤4,1≤n≤2.
Preferably, the angle of weave of close net braided support is close to thin net braided support, and the volume of two layers adjacent of support
Knit angle difference and be no more than 5 °, make multilayer tubular intravascular stent that there is identical cripetura rate when loading and compressing, so as to smoothly
It is loaded in induction system surface and carries out integral release.
In another preference, the vascular endoprostheses also include induction system, and the induction system is used for the pipe
Shape intravascular stent is delivered to target vessel lesion locations.
In another preference, every layer of tubular blood vessel support individually assembles by the induction system, by described defeated
Send system to push successively, and successively discharge to target vessel lesion locations and be combined into multilayer bracket.
In another preference, every layer of tubular blood vessel support is connected in the induction system inner tube.
In another preference, the tubular blood vessel support is integrally loaded in the induction system, by the delivery system
System is successively discharged to target vessel lesion locations.
In another preference, the tubular blood vessel support is conical design.
In another preference, the close net braided support is coated using overlay film.
In another preference, the thin net braided support is closed loop braided support.
In another preference, multilayer tubular intravascular stent is during conveying and release, after dredging the release of net braided support
Length should be greater than the length after the release of close net braided support, and dredge net braided support and should cover the length of close net braided support.
In another preference, the induction system is provided with the development positioner of developing ring and/or scaffolding thread, passes through institute
State developing ring and the development positioner control thin net braided support of the scaffolding thread and the phase of the close net braided support
To position.
In general, close net braided support should cover interlayer and aneurysm lesion locations, to realize to interlayer and aneurysm
Closure insulating effect, and dredge net braided support except covering interlayer and aneurysm lesion locations in addition to, should also extend to sustainer
Bend position, acted on providing preferably support and grappling.
In another preference, the braided wires of dredging net braided support are nitinol alloy wire, or platinum core nitinol alloy wire.
In another preference, the mesh knitted density for dredging net braided support is no more than 30.
In another preference, the mesh area for dredging net braided support is not less than 1mm2, it is preferable that more than 2mm2。
In another preference, the scaffolding thread diameter for dredging net braided support is not less than 0.1mm, it is preferable that 0.15-0.3mm.
In another preference, the angle of weave for dredging net braided support is not less than 90 °, it is preferable that 120-150 °.
In another preference, dredging net braided support has higher radial support power, for providing support for blood vessel, opens
Lead to true chamber blood flow.
In another preference, dredging net braided support is woven using monofilament, for realizing thin net braided support end
Closed loop weaves.
In another preference, the first and last end for dredging the braided wires of net braided support is handled using laser welding
In another preference, laser welding processing is included directly welding or welded using attachment structure.
In another preference, attachment structure includes welded pipe, welding piece, welding wire, pad etc..
In another preference, close net braided support is open loop braided support.
In another preference, the braided wires of close net braided support are nitinol alloy wire, or platinum core nitinol alloy wire.
In another preference, the mesh knitted density of close net braided support is not less than 30.
In another preference, close net braided support mesh area is no more than 1mm2, it is preferable that less than 0.3mm2。
In another preference, the scaffolding thread diameter of close net braided support is no more than 0.1mm, it is preferable that 0.05-
0.08mm。
In another preference, the angle of weave of close net braided support is 75-135 °.
Close net braided support act as isolation interlayer vacation chamber blood flow, changes false chamber blood flow velocity, increases true chamber blood flow stream
Speed.
In another preference, in multilayer tubular intravascular stent, close net braided support and thin net braided support multilayer group
Stent mesh area after conjunction should be less than 0.3mm2, it is preferable that less than 0.1mm2。
In another preference, the tubular blood vessel support metal coverage rate of blood vessel surface is not less than 10%, it is preferable that 20-
30%.
In another preference, tubular blood vessel support is preferably self-expanding metallic support.
In another preference, two layers adjacent of tubular blood vessel support, the external diameter of inner stent should be not less than outer stent
Internal diameter, specifically, inner stent external diameter should be greater than the 5-40% of outer stent internal diameter, it is preferable that 10-30%, so as to internal layer
Support can closely be attached to the inner surface of outer stent, without being shifted over.Internal layer and outer layer herein is according to adjacent two
What the mutual phase position of layer tubular blood vessel support defined；The external diameter and internal diameter of support refer to tubular blood vessel support in 37 DEG C of physiological saline
In, the external diameter and internal diameter that have under the nature under being fettered without external force.
In another preference, in multilayer tubular intravascular stent, the support both ends in internal layer and/or intermediate layer have enlarging
Design, so that support closely attaches outer stent, occurs without displacement, it is preferable that flaring angle is 5-30 °, and enlarging length is 5-
30mm。
In another preference, because blood vessel diameter is gradually reduced from proximal part to distal end, therefore, it is necessary to support has
Certain conical design, so that tubular blood vessel support can firmly be anchored on the inner surface of blood vessel and occur without displacement；It is preferred that
Ground, tubular blood vessel support are conical design, i.e., the diameter of mount proximal end is more than the diameter of rack far end, specifically, proximal diameter
Should be at least above distal diameter 3mm, preferably greater than 5-10mm.It should be noted that mount proximal end refers to support in implantation blood
Guan Hou, the support portions close to heart are mount proximal end, and the support portions away from heart are rack far end.
In another preference, the head end braided wires of close net braided support are open unclosed processing state.
In another preference, the both ends of close net braided support are coated using overlay film.
In another preference, overlay film is the non-degradable polymeric material of good biocompatibility, such as expanded polytetrafluoroethyl-ne
Alkene, PET overlay films, or absorbable polymer material, such as PLA, polycaprolactone, PLA-caprolactone copolymer.
In another preference, tubular blood vessel support head end is coated using overlay film, avoids open tubular blood vessel support head
The braided wires at end produce to blood vessel endothelium stimulates hyperplasia.
In another preference, the length 5-20mm of overlay film.
In another preference, close net braided support surface carries the active material for promoting endothelial growth, as Hematopoietic Stem is thin
Born of the same parents, CD34 antibody etc., so that close net braided support can realize the isolation plugging action to interlayer cut quickly by endothelialization.
In another preference, the length for dredging net braided support is more than the length of close net braided support.In aorta pectoralis,
The length of close net braided support is used for the cut for covering interlayer tear, blocks the entrance and exit of false chamber blood flow, and dredges net braiding
The length of support is outside one's consideration except covering the length of close net braided support, it is also necessary to and it is further to extend, realize to multilayer tubular blood vessel
The grappling effect of support.Specifically, for aorta dissection and aneurysm treatment, dredging net braided support can be from a liter active
Arteries and veins extends to aortic arch, and for descending aorta interlayer and aneurysm treatment, dredging net braided support can prolong from descending aorta
Grow to aortic arch and abdominal aorta.Extend and dredge net braided support to aortic arch, avoid the multilayer pipe at aorta ascendens
Shape intravascular stent is washed away to aortic arch by blood flow.Simultaneously because the mesh density for dredging net braided support is smaller, mesh area
It is larger, branch's blood flow of aortic arch will not be blocked.
In another preference, in multilayer tubular intravascular stent, the surface of close net braided support, particularly intermediate portion
Position, can be with local complexity certain length thin polymer film.
In another preference, absorbable polymer thin-film material is mixed PDLLA-polycaprolactone co-polymer, poly- breast
Acid-polyglycolic acid-polycaprolactone co-polymer or its blend etc..
In another preference, absorbable polymer film be by spraying, coating, the technique such as electrostatic spinning is coated in close
On net braided support.
In another preference, the degradation time of absorbable polymer film is 3 to 12 months, it is preferable that 3 to 6 months.
In another preference, the thickness of absorbable polymer film is with less than 100 μm；Preferably below 50 μm；More preferably
Ground, or less than 30 μm.
In another preference, the length of absorbable polymer film is fewer 5-30mm than the length of close net braided support.
In another preference, absorbable polymer film has good extension characteristics.
The main function of absorbable polymer film is realizes the closure to interlayer cut blood flow, in the mistake of support endothelialization
Cheng Zhong, film are gradually degraded, and are not influenceed support and are covered by endothelium, therefore film does not use nondegradable polymer thin
Film, such as expanded polytetrafluoroethylsealing, existing clinical literature show, sustainer film frame due to surface covers one layer can not
The thin-film material of degraded, rack surface are difficult that endothelialization occurs.
It should be understood that within the scope of the present invention, above-mentioned each technical characteristic of the invention and have in below (eg embodiment)
It can be combined with each other between each technical characteristic of body description, so as to form new or preferable technical scheme.As space is limited, exist
This no longer tires out one by one states.
Brief description of the drawings
In order to illustrate more clearly about the embodiment of the present invention or technical scheme of the prior art, below will be to embodiment or existing
There is the required accompanying drawing used in technology description to do and simply introduce, it should be apparent that, drawings in the following description are only this
Some embodiments of invention, for those of ordinary skill in the art, on the premise of not paying creative work, can be with
Other accompanying drawings are obtained according to these accompanying drawings.
Fig. 1 a are the front views of the close net braided support in an example of the invention.
Fig. 1 b are the perspective views of the close net braided support in an example of the invention.
Fig. 2 a are the front views of the close net braided support of the enlarging design in an example of the invention.
Fig. 2 b are the perspective views of the close net braided support of the enlarging design in an example of the invention.
Fig. 3 a are the front views of the thin net braided support in an example of the invention.
Fig. 3 b are the perspective views of the thin net braided support in an example of the invention.
Fig. 4 is that the close net braided support in an example of the invention and the mesh after the combination of thin net braided support are staggeredly illustrated
Figure.
Fig. 5 a are the front views of the close net braided support of the middle cladding overlay film in an example of the invention.
Fig. 5 b are the perspective views of the close net braided support of the middle cladding overlay film in an example of the invention.
Fig. 6 a are the front views of the close net braided support of the both ends cladding overlay film in an example of the invention.
Fig. 6 b are the perspective views of the close net braided support of the both ends cladding overlay film in an example of the invention.
In each accompanying drawing, each sign is as follows：
The close net braided supports of 1-；
2- dredges net braided support.
Embodiment
The present inventor by largely screening, develops a kind of vascular endoprostheses, is somebody's turn to do first by in-depth study extensively
Vascular endoprostheses are combined by the braided support of multiple different counts, can not be had for solving existing overlay film frame
The problem of effect treatment dissection of aorta, particularly aorta dissection, the present invention is completed on this basis.
Term
As used herein, term " mesh knitted density " refers to the quantity of mesh on 1 inchage of support axial direction.
As used herein, term " angle of weave " refers to the angle that cross one another braided wires are in axial direction formed.
The invention provides a kind of vascular endoprostheses, and it is a kind of vascular endoprostheses with specific structure.
Typically, the vascular endoprostheses include i layer tubular blood vessel supports, wherein, 2≤i≤8, for treating aorta clamp
Layer and aneurysm lesion, particularly Ascending Aortic Aneurysm interlayer, and tubular blood vessel support is divided into close net braided support and thin net weaves
Support, the mesh density of close net braided support is larger, and the mesh density for dredging net braided support is smaller；The quantity of close net braided support
For m, wherein, 1≤m≤4；The quantity for dredging net braided support is n, wherein, 1≤n≤4；And i=m+n；Close net braided support and dredge
Net braided support is circumferentially coaxially stacked, and for cooperateing with support blood vessels, and mutually limits the axial elongation of the support
Or cripetura deformation.
A kind of multilayer tubular intravascular stent system, formed by 2-6 layer holder combinations, every layer of support is independent by induction system
Assembling, is successively discharged to target vessel lesion locations by induction system and is combined into multilayer bracket；Or multilayer bracket be integrally loaded in it is defeated
Send in system, successively discharged by induction system to target vessel lesion locations.
A kind of multilayer tubular intravascular stent system, formed by 2-6 layer holder combinations, the external diameter of every layer of support is at least in 10mm
More than.Every layer of support is connected in induction system inner tube, is pushed successively by induction system, by every layer of support release in target vessel disease
Become position and be combined into multilayer bracket；Or multilayer bracket is integrally loaded in induction system, successively discharged by induction system to target blood
Pipe lesion locations.
A kind of multilayer tubular intravascular stent system, formed by 2-6 layer holder combinations, multilayer bracket is integrally loaded in delivery system
On system, successively discharged by induction system to target vessel lesion locations.
Main advantages of the present invention include：
(a) multiple tubular blood vessel supports can be conveyed by an induction system；Save the use of induction system
Cost；
(b) multiple tubular blood vessel support stacked combinations, the mesh area of very little is produced, the blood of false chamber can be effectively reduced
Stream, and isolation is done step-by-step and blocks the effect of false chamber blood flow；
(c) braided support has good compliance, can smoothly cross over aortic arch；
(d) because each tubular blood vessel support can be conveyed individually, stent delivery system have very little by external diameter,
Stent delivery system can be less than 18F (it is about diameter 6mm that 1F, which is approximately equal to diameter 0.33mm, 18F) by external diameter, can pass through
Femoral artery, subclavian artery etc. carry out puncture for treating, are conveyed without cutting off stock common iliac artery；
(e) multilayer bracket will not cause to block to aortic arch blood flow, no brain thrombotic risk, and combination formula
Support has good stent anchors effect, and support does not shift risk, while branch's blood flow of aortic arch is still kept
It is unobstructed；
(f) the most long support in support both ends weaves closed loop support to dredge net, i.e., the braided mesh density of support is relatively dredged, mesh
It is larger, at the same the head end of support to close continuous weaving, the head ends of braided wires is not exposed in outer contacting vascular wall, will not stimulate
Blood vessel endothelium hyperplasia；
(g) there is overlay film cladding at close net braided support both ends, will not equally stimulate blood vessel endothelium hyperplasia；
(h) there is overlay film cladding among close net braided support, can preferably completely cut off and block dissection of aorta；
(i) close net braided support surface carries the active material for promoting endothelial growth, such as candidate stem cell, CD34 antibody
Deng so that close net braided support can realize the isolation plugging action to interlayer cut quickly by endothelialization；
(j) multiple layer combination support has good support force and compliance.
Therefore, multilayer tubular intravascular stent of the invention be able to can have with the pipeline configuration of simulated blood vessel multiple-layer recombination hollow
Effect by support Surgery dissection of aorta, PCI aorta clamp can not be carried out by particularly treating current clinic
Layer or aneurysm.
With reference to specific embodiment, the present invention is expanded on further.It should be understood that these embodiments are merely to illustrate the present invention
Rather than limitation the scope of the present invention.In addition, accompanying drawing is schematic diagram, therefore apparatus of the present invention and equipment are not shown by described
Size or the ratio limitation of intention.
It should be noted that in the claim and specification of this patent, such as first and second or the like relation
Term is used merely to make a distinction an entity or operation with another entity or operation, and not necessarily requires or imply
Any this actual relation or order be present between these entities or operation.Moreover, term " comprising ", "comprising" or its
Any other variant is intended to including for nonexcludability so that process, method, article including a series of elements or
Equipment not only includes those key elements, but also the other element including being not expressly set out, or also include for this process,
Method, article or the intrinsic key element of equipment.In the absence of more restrictions, wanted by what sentence " including one " limited
Element, it is not excluded that other identical element in the process including the key element, method, article or equipment also be present.
Embodiment 1
The tubular blood vessel support of the present embodiment uses three layers of support Design, and outer layer is one layer of thin net closed loop support, and internal layer is
Two layers of close net braided support.Fig. 1 a and Fig. 1 b show the close net braided support of the present embodiment, and Fig. 3 a and Fig. 3 b show this reality
Apply the thin net braided support of example.The scaffolding thread of close net braided support is platinum core nitinol alloy wire, to provide more preferable developability.
The scaffolding thread diameter of close net braided support is 0.075mm, mesh area 0.5mm2, 120 °, proximal outer diameter 45mm of angle of weave,
Distal outer diameter 40mm, length 60mm.Dredge a diameter of 0.15mm, mesh area 2mm of the scaffolding thread of net closed loop braided support2, compile
Knit 150 °, proximal outer diameter 40mm, distal outer diameter 35mm of angle, length 100mm.
The tubular blood vessel support of the present embodiment is when for treating DeBakey type III lesions, every layer of tubular blood vessel support
Individually assembled by induction system, successively discharged to target vessel lesion locations by induction system and be combined into multilayer bracket.By means of
The development positioning of the developing ring and scaffolding thread of induction system, first discharges thin net braided support to the arch of aorta and descending aorta
Position, net braided support covering interlayer length of lesion is dredged, and extend to arch of aorta position., will after dredging the release of net braided support
Close net braided support release is determined in thin net braided support inner surface, the development by means of the developing ring and scaffolding thread of induction system
Position, close net braided support is controlled to be completely covered interlayer lesion locations, the near-end of close net braided support can be under local complexity left clavicle
Artery, to realize that the abundant isolation to interlayer entrance covers.But the near-end of close net braided support, which can not exceed, dredges net braided support
Near-end.After close net braided support release, net braided support is dredged because its nominal diameter is more than, and the head end of close net braided support
For braiding of scattering, the braided wires at both ends are embedded into the mesh of thin net braided support, and close net braided support can be achieved and be brought into close contact
The inner surface of net braided support is being dredged without being shifted over.Wherein, the net after close net braided support and thin net braided support combine
The hole schematic diagram that interlocks is as shown in Figure 4.
After support release, due to the isolation iris action of close net braided support, the blood flow velocity of interlayer entrance slows down, by
Gradually form thrombus solidification.Interlayer is gradually blocked.The COF power induction of vascular endothelial of support is organized in cradling piece superficial growth simultaneously
And rack surface is covered, coated stent surface forms endodermis, so as to which closure completely cuts off interlayer completely.
Embodiment 2
The tubular blood vessel support of the present embodiment is similar to embodiment 1, and difference is the close net braiding branch of two layers of the present embodiment
Frame is enlarging design.Fig. 2 a and Fig. 2 b show the close net braided support of the present embodiment, the scaffolding thread of the close net braided support
0.05mm, mesh area 0.3mm2, 90 ° of angle of weave；It is enlarging processing, 15 ° of flaring angle, enlarging length 10mm in end；Closely
Hold external diameter 48mm, distal outer diameter 43mm (being the external diameter of non-enlarging)；Length 50mm.The loading of tubular blood vessel support, release are equal
It is similar to Example 1.
The present embodiment therapeutic effect is with embodiment 1, compared with Example 1, because the close net braided support of embodiment 1 does not expand
Mouth design, the close net braided support of the present embodiment even closer can be fitted in the inner surface of thin net braided support without moving
Position.
Embodiment 3
The scaffolding thread of the tubular blood vessel support of the present embodiment is titanium-nickel wire, and support uses four layers of support Design, this implementation
The tubular blood vessel support of example includes outer layer, internal layer and intermediate layer, wherein, intermediate layer is two layers of close net braided support, outer layer and interior
Layer respectively has one layer of thin net braided support, and the angle of weave of close net braided support is not equal to the establishment angle for dredging net braided support,
The angle of weave of two layers adjacent of support is also not mutually equal, and the angle of weave of two layers adjacent of support differs 15-60 °, so as to phase
Adjacent weave mesh, which is overlapped mutually, produces smaller mesh, realizes and effectively completely cuts off sealing process to false chamber blood flow, in addition, as schemed
Shown in 5a and Fig. 5 b, to realize, preferably closure isolation effect, the Neutral colour of close net braided support have one layer of overlay film, the length of overlay film
Spend for 25mm.The overlay film is absorbable polymer film, the techniques such as spraying, coating, electrostatic spinning can be used to be coated on overlay film
On close net braided support.The degradation time of absorbable polymer film is 3 to 6 months, meanwhile, the absorbable polymer film should
With good extension characteristics, extension deformation can be together produced with support.The main function of absorbable polymer film is realization
Closure to interlayer cut blood flow, during support endothelialization, film is gradually degraded, and is not influenceed support and is covered by endothelium
Lid.
The loading of tubular blood vessel support, release are similar to Example 1, wherein, two layers of close net braided support in intermediate layer
It can select integrally to convey by induction system, i.e., the tubular blood vessel support of the present embodiment can be defeated by integrally conveying and being layered
Send, the two mode combined discharges to target vessel lesion locations and is combined into multilayer bracket.The present embodiment therapeutic effect is the same as implementation
Example 1.
Embodiment 4
The scaffolding thread of the tubular blood vessel support of the present embodiment is titanium-nickel wire, and support uses two layers of support Design, this implementation
The tubular blood vessel support of example includes outer layer and internal layer, wherein, outer layer is close net braided support, and internal layer is to dredge net braided support；It is interior
Outer braid support carries out integral conveying using same induction system；The angle of weave of close net braided support and thin net braided support
It is 135 °, different support cripeturas is produced after avoiding two layers of braided support compression；In addition, as shown in figures 6 a and 6b, close net
The both ends of braided support are coated using overlay film, and the length of the overlay film at both ends is 10mm.Overlay film is inhaled by good biocompatibility
Receive polymeric material to be made, such as PLA, polycaprolactone, PLA-caprolactone copolymer；Close net braided support head end covers
Film cladding design avoids open support head end braided wires and stimulation hyperplasia is produced to blood vessel endothelium.It is taper to dredge net braided support
Design, the i.e. diameter of mount proximal end are more than the diameter of rack far end, are gradually contracted from proximal part to distal end with adapting to blood vessel diameter
It is small, and then tubular blood vessel support is firmly anchored on the inner surface of blood vessel and is occurred without displacement.After avoiding release
Close net braided support dredges the displacement of net braided support relatively, it is preferred to use close net braided support is sewn to by suture dredges net braiding branch
The outer surface of frame.
The tubular blood vessel support of the present embodiment is when for treating DeBakey II type lesions, according to interlayer and aneurysmal
Length selection is adapted to the close net braided support of length of lesion, and may extend to the thin net braided support of the arch of aorta.By means of defeated
The development positioning of the developing ring and scaffolding thread of system is sent, is discharged support to target vessel lesion locations by induction system.Close net is compiled
Knit support covering aorta dissection, can local complexity truncus brachiocephalicus artery, to realize that abundant isolation to interlayer cut covers.Dredge
Net braided support extends to the arch of aorta, to improve the anchoring effect of support.The present embodiment therapeutic effect is the same as embodiment 1.
All it is incorporated as referring in this application in all documents that the present invention refers to, it is independent just as each document
It is incorporated as with reference to such.In addition, it is to be understood that after the above-mentioned instruction content of the present invention has been read, those skilled in the art can
To be made various changes or modifications to the present invention, these equivalent form of values equally fall within the model that the application appended claims are limited
Enclose.
Claims (10)
- A kind of 1. vascular endoprostheses, it is characterised in that the vascular endoprostheses include i layer tubular blood vessel supports, wherein, 2≤i≤ 8, for treating dissection of aorta and aneurysm lesion, particularly Ascending Aortic Aneurysm interlayer and abdominal aneurvsm interlayer；The tubular blood vessel support is divided into close net braided support and thin net braided support, the mesh density of the close net braided support Larger, the mesh density of the thin net braided support is smaller；The quantity of the close net braided support is m, wherein, 1≤m≤4；The quantity of the thin net braided support is n, wherein, 1≤ n≤4；And i=m+n；The close net braided support and the thin net braided support are circumferentially coaxially stacked, for cooperateing with support blood vessels, And mutually limit axial elongation or the cripetura deformation of the support.
- 2. vascular endoprostheses as claimed in claim 1, it is characterised in that the vascular endoprostheses include internal layer and outer layer, its In, the outer layer is the thin net braided support, and the internal layer is the close net braided support, and the mesh of the braided support is close Degree increases successively from outer layer to internal layer, wherein 1≤m≤4,1≤n≤2；And the both ends of the close net braided support set for enlarging Meter, 5-30 ° of flaring angle, enlarging length is 5-30mm.
- 3. vascular endoprostheses as claimed in claim 1, it is characterised in that the vascular endoprostheses include outer layer, internal layer and in Interbed, wherein, the intermediate layer is the close net braided support, and the outer layer and the internal layer are to dredge net braided support, from institute State intermediate layer to the outer layer or to the internal layer, the mesh density of the braided support successively to successively decrease, the net in the intermediate layer Hole density is maximum；The quantity in the intermediate layer is 1-3 layers, and the quantity of the outer layer and the internal layer is 1-2 layers.
- 4. vascular endoprostheses as claimed in claim 1, it is characterised in that the vascular endoprostheses include internal layer and outer layer, its In, the outer layer is the close net braided support, and the internal layer is the thin net braided support, and the mesh of the braided support is close Degree is sequentially reduced from outer layer to internal layer, wherein 1≤m≤4,1≤n≤2.
- 5. vascular endoprostheses as claimed in claim 1, it is characterised in that the vascular endoprostheses also include induction system, institute Induction system is stated to be used to the tubular blood vessel support being delivered to target vessel lesion locations.
- 6. vascular endoprostheses as claimed in claim 5, it is characterised in that every layer of tubular blood vessel support is by the conveying System individually assembles, and is pushed successively by the induction system, and successively discharges to target vessel lesion locations and be combined into multilayer bracket.
- 7. vascular endoprostheses as claimed in claim 5, it is characterised in that the tubular blood vessel support is integrally loaded in described defeated Send in system, successively discharged to target vessel lesion locations by the induction system.
- 8. vascular endoprostheses as claimed in claim 1, it is characterised in that the tubular blood vessel support is conical design.
- 9. vascular endoprostheses as claimed in claim 1, it is characterised in that the close net braided support is coated using overlay film.
- 10. vascular endoprostheses as claimed in claim 1, it is characterised in that the thin net braided support is closed loop braided support.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710959607.6A CN107811728A (en) | 2017-10-16 | 2017-10-16 | Vascular endoprostheses |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710959607.6A CN107811728A (en) | 2017-10-16 | 2017-10-16 | Vascular endoprostheses |
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| CN107811728A true CN107811728A (en) | 2018-03-20 |
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| CN111134920A (en) * | 2020-01-22 | 2020-05-12 | 北京弘海微创科技有限公司 | Close net support |
| CN111249046A (en) * | 2020-01-22 | 2020-06-09 | 北京立德微创科技有限公司 | Close net support of lumen |
| CN112022461A (en) * | 2020-09-16 | 2020-12-04 | 北京美迪微科技有限责任公司 | Be applied to intravascular stent of carotid |
| CN114028049A (en) * | 2021-12-21 | 2022-02-11 | 南京纽诺英特医疗科技有限公司 | Intracranial support bracket |
| CN115429484A (en) * | 2022-08-09 | 2022-12-06 | 上海玮琅医疗科技有限公司 | Braided superior vena cava tectorial membrane stent and manufacturing process thereof |
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| CN115429484A (en) * | 2022-08-09 | 2022-12-06 | 上海玮琅医疗科技有限公司 | Braided superior vena cava tectorial membrane stent and manufacturing process thereof |
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