CN109091271A - Aorta ascendens stent graft - Google Patents

Aorta ascendens stent graft Download PDF

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Publication number
CN109091271A
CN109091271A CN201810379341.2A CN201810379341A CN109091271A CN 109091271 A CN109091271 A CN 109091271A CN 201810379341 A CN201810379341 A CN 201810379341A CN 109091271 A CN109091271 A CN 109091271A
Authority
CN
China
Prior art keywords
aorta
stent graft
aorta ascendens
stent
ascendens
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810379341.2A
Other languages
Chinese (zh)
Inventor
景在平
冯家烜
鲍贤豪
冯睿
周建
陆清声
李涛
包俊敏
赵志青
毛华娟
庄郁峰
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Changhai Hospital
Original Assignee
Shanghai Changhai Hospital
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shanghai Changhai Hospital filed Critical Shanghai Changhai Hospital
Priority to CN201810379341.2A priority Critical patent/CN109091271A/en
Priority to JP2021508038A priority patent/JP2021522037A/en
Priority to EP18915822.3A priority patent/EP3785665A4/en
Priority to PCT/CN2018/116151 priority patent/WO2019205599A1/en
Priority to US17/050,634 priority patent/US20210244525A1/en
Publication of CN109091271A publication Critical patent/CN109091271A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2415Manufacturing methods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466Delivery devices therefor

Abstract

The invention discloses a kind of aorta ascendens stent grafts, are related to medical instruments field.The aorta ascendens stent graft includes: bracket;At least partly cover the nappe of the bracket;For rebuilding the leaflet of aorta petal, the leaflet is arranged in the proximal part of the bracket and connect with the bracket and nappe.The aorta ascendens stent graft of embodiment according to the present invention, with the leaflet for rebuilding aorta petal, the leaflet is suitable for that the blood stream of left ventricle is made to enter aorta and prevents blood from aortic regurgitation to left ventricle;In addition, can have on stent graft, there are two the windowings for being suitable for being aligned two coronary ostiums.Therefore, for the Aortic root abnormality for having involved aortic sinus and aorta petal simultaneously, the aorta ascendens stent graft can be implanted by root of ascending aorta using endovascular stent-grafts exclusion art, repair aorta ascendens, aorta petal, aortic sinus, coronary ostium are rebuild, reaches integration and cures purpose.

Description

Aorta ascendens stent graft
Technical field
The present invention relates to the field of medical instrument technology, and in particular, to one kind is suitable for treatment and involves aortic sinus, coronal dynamic Arteries and veins opening, the aorta dissection of aorta petal and aortic aneurysm, aortic stenosis or incompetence are with aortic aneurysm etc. Aorta ascendens stent graft.
Background technique
Dissection of aorta refers to that high speed and high pressure blood flow passes through film in the inner membrance tearing port entrance on aorta wall in aorta At outer layer or China and foreign countries' membrane junction, to form true and false two chamber of aorta, and is axially expanded along aorta, can lead to aortoclasia Or bifurcated artery ischemic (heart infarction, cerebral infarction, internal organ or lower limb ischemia) etc., it is one of the disease for involving aorta most serious.Previously There is research to be counted according to the position of dissection of aorta proximal end breach to the interlayer of aorta different parts: proximal end breach position The 65% of all dissection of aorta is accounted in the dissection of aorta of aorta ascendens, accounts for 5% positioned at aortic arch, is located at drop actively Arteries and veins accounts for about 30%.Aortic aneurysm refers to the pathologic expansion of aorta, more than the 50% of normal blood vessels diameter, can betide master The positions such as artery sinus, aorta ascendens, the arch of aorta, descending thoracic aorta, thoracoabdominal aorta, abdominal aorta, warty rupture can cause sudden Extremely.Aortic aneurysm positioned at aorta ascendens often involves aortic sinus, and aorta petal annular strain, leaflet is made to separate and cause aorta petal Incompetence, it is long-term to influence to cause heart failure.
It is located at the aorta clamp of descending aorta, aortic arch and aorta ascendens middle section 1/3 for proximal end breach and knurl Layer and aortic aneurysm cover the stent graft isolation proximal end breach of artificial blood vessel's film, false chamber and artery knurl thrombus by being implanted into Change and reduce, the true chamber expansion of interlayer reaches healing purpose.This treatment method is compared with conventional therapy, without opening chest, defeated Blood and extracorporal circulatory system, it is simple and direct minimally invasive, curative for effect.
With the progress of support in blood-vessel graft and technology, using stent graft Minimally Interventional Therapy aorta clamp Layer from classical descending aorta interlayer, develops to most of dissection of aorta and the master that can be handled in addition to aortic root Aneurysm.However, for Aortic root abnormality (Ascending Aortic Aneurysm or aorta dissection, companion aortic stenosis and/or pass Close incomplete), it can only be treated at present using open surgical procedures, as Bentall operation (uses the terylene blood with prosthetic aortic valve Pipe displacement technique, and coronary artery is replanted into terylene blood vessel), Wheat operation etc..These open surgery modes require heart and stop It fights, extracorporal circulatory system, operation wound is huge, and the death rate, complication rate are high.Needing one kind being capable of endovascular stent-grafts exclusion aortic root The medical apparatus of lesion.
Summary of the invention
Embodiments of the present invention provide a kind of aorta ascendens branch suitable for endovascular stent-grafts exclusion Aortic root abnormality Frame graft comprising: bracket;At least partly cover the nappe of the bracket;It is described for rebuilding the leaflet of aorta petal Leaflet is arranged in the proximal part of the bracket and connect with the nappe and bracket.Optionally, have on stent graft Two are suitable for being aligned the windowing of two coronary ostiums.
Aorta ascendens stent graft according to the present embodiment, with the leaflet for rebuilding aorta petal, the leaflet Blood stream suitable for making left ventricle enters aorta and prevents blood from aortic regurgitation to left ventricle.Therefore, for involve actively The aorta ascendens stent graft can be implanted into aortic valvular ring using endovascular stent-grafts exclusion art by the aortic disease of arteries and veins root To root of ascending aorta, Study on Ascending Aortic Lesions is repaired, aorta petal is rebuild, reaches healing purpose.
In another embodiment of the invention, the bracket includes being suitable for implantation into the main support of aorta ascendens and position It is suitable for implantation into the distal end of main support to the first sub-stent of bifurcated artery.The bifurcated artery is including but not limited to unknown Dry artery, left common carotid artery and left subclavian artery.
Aorta ascendens stent graft according to the present embodiment can pass through the first branch in minimally invasive intervention operation The aorta ascendens stent graft is limited to the suitable position of aorta ascendens by frame, for example, moving the aorta ascendens bracket The proximal part of plant can accurately be anchored to aortic valvular ring, and the coronary artery windowing on stent graft can be accurately aimed at coronary artery and open Mouthful, interlayer proximal end breach or aneurysm are completely cut off on the basis of accurate reconstruction aorta petal and coronary artery, so that interlayer vacation chamber Or artery knurl thrombosis and atrophy, reach healing purpose.In addition, aortic disease involve arch of aorta top set artery and It, can be by primary intracavitary minimally invasive using the aorta ascendens stent graft of present embodiment in the case where aorta ascendens the two The healing to both arch of aorta top set artery and aorta ascendens, this aorta ascendens-arch of aorta integration are realized in operation Reconstruction mode has higher stability, stent graft displacement close, at a specified future date occurs, coronary artery windowing is caused to lose contraposition, delayed The Hazard ratio modular support graft of interior leakage etc. is smaller.
In an alternative embodiment of the invention, in the state of the aorta ascendens stent graft radial expansion, institute It states main support and is about 35-155mm in substantially tubular, and the diameter of its proximal part is 22-48mm, the diameter of distal end is 30- 50mm.The diameter of the main support can be consistent from its proximal part to distal end along its axial direction, can also first become larger then It gradually becomes smaller, one section of horn-like structure can also be had in its proximal part, wherein main support maximum gauge is 28-50mm.
Aorta ascendens stent graft according to the present embodiment is conducive to planting based on the form after its radial expansion Suitable position in aorta is anchored on after entering.
Further, or alternatively, in the state of the aorta ascendens stent graft radial expansion, described first Sub-stent is 6-16mm in the substantially diameter of tubular and its proximal part, and the diameter of distal end is 10-26mm.For example, described first Sub-stent is in horn-like, that is, the diameter of first sub-stent can become larger along its axial direction from its proximal part to distal end.
According to the aorta ascendens stent graft of embodiment, the nearly heart is greater than by the diameter of the distal end of the first sub-stent The setting of the diameter at end is conducive to be anchored on the suitable position of arch of aorta top set intra-arterial after the implants, prevent The interior leakage of distant source.
In another embodiment of the present invention, the aorta ascendens stent graft further includes inner support;Described first A part of sub-stent and the inner support are disposed side by side in the main support, the distal end of the inner support and the main branch The distal end of frame substantially in a plane or the distal end of the inner support exceed the main support distal end;Also, The distal end of the main support, the inner circumferential of the periphery of first sub-stent, the periphery of the inner support and the main support it Between gap pass through seal seal.
Aorta ascendens stent graft according to the present embodiment can by being arranged the structure of sub-stent in main support So that main housing portion is preferably bonded vascular wall, and it is anchored in position, to the disease for involving aorta ascendens intermediate region Become, such as aortic aneurysm, there is better therapeutic effect.
In another embodiment of the present invention, the bracket further includes adjacent with first sub-stent and is suitable for direction Or enter the second sub-stent of the arch of aorta.
Aorta ascendens stent graft according to the present embodiment, in minimally invasive intervention operation, except through the first branch The aorta ascendens stent graft can also be limited to the suitable position of aorta ascendens by the second sub-stent by frame, for example, Enable the aorta ascendens stent graft secure anchorage in aorta ascendens, prevent to shift, or occurs from remote The interior leakage at heart end.In addition, involving coronary artery in aortic disease, the former two or three in aorta ascendens and arch of aorta proximal end In the case where all involving, using the aorta ascendens stent graft of present embodiment, intracavitary minimally invasive it can be realized by primary Complete intracavitary healing has higher stability, stent graft displacement close, at a specified future date occurs, coronary artery windowing is caused to lose contraposition, slow The Hazard ratio modular support graft of leakage etc. is smaller in hair style, while being also further Stent Implantation transplanting in the second sub-stent Object rebuilds arch of aorta distal end and descending aorta provides joining section.Meanwhile toward or into the second sub-stent of the arch of aorta Arch of aorta distal end is rebuild for further Stent Implantation graft and descending aorta provides joining section.
Optionally, in the state of the aorta ascendens stent graft radial expansion, second sub-stent is in substantially The diameter of tubular and its proximal part is 25-42mm, and the diameter of distal end is 25-50mm.The diameter of second sub-stent is along it It is axial to be become larger from its proximal part to distal end.
According to the aorta ascendens stent graft of embodiment, the nearly heart is greater than by the diameter of the distal end of the second sub-stent The setting of the diameter at end further helps in and is anchored on suitable position in aorta after the implants, prevents distal end and comes The interior leakage in source.
In other optional embodiments of the invention, in the proximal part tool close to main support, there are two be suitable for alignment two Windowing coronarius.For example, the windowing is arranged at the proximal part 5-50mm away from bracket.Described in being arranged in proximal part Opening can retain coronary blood confession.
Further, edge opposite in the horizontal direction of the windowing, which is respectively equipped with, is suitable for being implanted into the liter actively Label during arteries and veins stent graft for contraposition.According to the present embodiment, it is being implanted into the aorta ascendens structural transplantation During object, the label to develop under X-ray being arranged at coronary artery tangent position, the front and rear edges of windowing is overlapped to ensure Windowing alignment coronary opening.Alternatively, further, in the middle section part in the main support and the part close to distal end extremely In one few, two sides opposite in the horizontal direction are respectively equipped with the process being suitable for being implanted into the aorta ascendens stent graft In for contraposition label.In this way, can further pass through multiple alignment marks of aorta ascendens stent graft different location To promote aligning accuracy.
In other optional embodiments of the invention, in the state of the aorta ascendens stent graft radial expansion Under, the aorta ascendens stent graft is in drum type close to one section of proximal part.Optionally, the nearly heart edge distance branch of the drum type The distance of the nearly heart edge of frame is 0-50mm, also, the drum type is 3-15mm along the radially projecting maximum overhang of the bracket, Drum type height is 10-30mm.In this way, the enough work of aorta petal can be provided in the proximal part of aorta ascendens stent graft Dynamic space, blocks windowing coronarius to avoid aorta petal.In addition, such shape design also helps a liter active The proximal part of arteries and veins stent graft is bonded with aortic root, is conducive to aorta ascendens reconstruction.
In other optional embodiments of the invention, the proximal part outer surface of stent graft is in horn-like, i.e., the close heart The bore at end is slightly larger, is then gradually reduced, and the length of this horn-like structure is 0-40mm, the proximal part bore of horn-like structure 22-48mm。
In conclusion being capable of intracavitary minimally-invasive treatment aortic root disease using aorta ascendens stent graft of the invention Become, for example, it is narrow to involve aortic sinus, coronary ostium, the aorta dissection of aorta petal and aortic aneurysm, aorta petal Narrow or incompetence is with aortic aneurysm or/and dissection of aorta etc..
Various aspects, feature, advantage of embodiment of the present invention etc. are specifically described below in connection with attached drawing.According to Below in conjunction with the specific descriptions of attached drawing, aforementioned aspect of the present invention, feature, advantage etc. be will become apparent.
Detailed description of the invention
Fig. 1 is a kind of schematic elevation view of the aorta ascendens stent graft of embodiment according to the present invention.
Fig. 2 is a kind of schematic top plan view of the aorta ascendens stent graft of embodiment according to the present invention.
Fig. 3 is a kind of elevational schematic view of the aorta ascendens stent graft of embodiment according to the present invention.
Fig. 4 is to show the signal of the aorta ascendens stent graft implantation endovascular situation of aorta ascendens shown in FIG. 1 Figure.
Fig. 5 is the aorta ascendens stent graft with drum type proximal part of another embodiment according to the present invention The height H of drum type is marked in schematic elevation view.
Fig. 6 is another schematic elevation view of the aorta ascendens stent graft shown in fig. 5 with drum type proximal part, mark The overhang h of drum type is remembered.
Fig. 7 is the stereoscopic schematic diagram of the aorta ascendens stent graft of another embodiment according to the present invention.
Fig. 8 is after the excision of aorta ascendens stent graft shown in Fig. 7 is located at the first sub-stent outside main support Schematic top plan view.
Fig. 9 is to show the signal of the aorta ascendens stent graft implantation endovascular situation of aorta ascendens shown in Fig. 7 Figure.
Figure 10 is the experiment knot for showing the aorta ascendens stent graft implantation animal of embodiment of the present invention and being tested The set of the picture of fruit.
Figure 11 is to show the aorta ascendens branch with horn-like proximal part of another embodiment according to the present invention The schematic diagram of the frame graft implantation endovascular situation of aorta ascendens.
Specific embodiment
The various aspects of technical solution, feature and advantage to facilitate the understanding of the present invention, with reference to the accompanying drawing to this hair It is bright to be specifically described.It should be appreciated that following various embodiments are served only for for example, and is not intended to limit the present invention Protection scope.
Herein, it will be appreciated by those skilled in the art that term " substantially tubular " includes " tubular " and " with tubular phase Seemingly, similar, close or alike shape ", sentence " substantially in a plane " description situation include feelings in a plane Shape and approximate situation in a plane.
Fig. 1 is a kind of schematic elevation view of the aorta ascendens stent graft of embodiment according to the present invention.
Fig. 2 is a kind of schematic top plan view of the aorta ascendens stent graft of embodiment according to the present invention.Fig. 3 is root According to the elevational schematic view of the aorta ascendens stent graft of one embodiment of the present invention.In Fig. 1, bottom is nearly heart side (end), top are telecentricity side (end).The aorta ascendens bracket that one embodiment of the present invention is provided below with reference to Fig. 1 to Fig. 3 Graft is specifically described.
In the present embodiment, aorta ascendens stent graft may include: bracket 100, cover covering for the bracket 100 Lid 200, the leaflet 300 for rebuilding aorta petal and the windowing 401,402 coronarius of alignment two.Wherein, described Leaflet 300 is arranged in the proximal part of the bracket 100 and connect with the nappe 200 and bracket 100, for example, the valve Leaf 300 can be sewn on the nappe 200 and bracket 100.To when the aorta ascendens stent graft is implanted into aorta Intravascular, the leaflet 300 makes the blood stream of left ventricle enter aorta and prevents blood from aortic regurgitation to left ventricle.
For ease of description, the bracket 100 that coating lid 200 covers, in the present embodiment, institute is shown in the attached drawings State support construction or skeleton of the bracket 100 as the aorta ascendens stent graft, can be made of scaffolding thread, it is specific and Speech, can be formed by metal wire knitted, be also possible to self-inflated nick-eltitanium alloy stent.The nappe 200 can be artificial blood Periosteum.It can be sutured integrally by nonabsorable suture between bracket 100 and nappe 200, the side such as hot pressing, bonding can also be used Formula is connected as one.The leaflet 300 can be the biology made of the biomaterials such as bovine pericardium, Pigs Hearts packet, donkey pericardium Valve, quantity can be three, and after three leaflets are sewn on overlay film body and bracket, shape is respectively as a " pocket ", to surround three A aortic sinus.
In the present embodiment, the aorta ascendens stent graft can have in the proximal part close to the bracket 100 Suitable for being directed at the windowing 401,402 of two coronary ostiums.For example, the nearly heart edge of the windowing is arranged in away from bracket 100 At proximal part 5-50mm, for example, be arranged at the proximal part 15mm away from bracket 100, at 25mm, at 35mm etc., it specifically can root It is appropriately arranged with according to the arterial vascular structure of patient.For example, the proximal part of the nearly heart edge distance bracket graft of windowing 401 25mm, open a window 402 nearly heart edge distance bracket graft proximal part 27.5mm.In this way, coronary blood supply can be retained.It needs to illustrate , it will be appreciated by those skilled in the art that the windowing can preoperative customization molding, can also in art on operating table it is interim Windowing will be directed at the part nappe at coronary artery and remove, so that internal stent is communicated with coronary flow.At other In embodiment, nappe 200 can partially cover bracket 100, i.e., do not cover bracket 100 at alignment coronary artery, this Can internal stent be communicated with coronary flow.
In other optional embodiments, edge that can be opposite in the horizontal direction of the windowing is (for example, positive opponent The front and rear edges of art doctor) it is respectively equipped with the mark being suitable for during being implanted into the aorta ascendens stent graft for contraposition Note.According to the present embodiment, during being implanted into the aorta ascendens stent graft, in coronary artery tangent position, windowing The label overlapping developed under X-ray being arranged at front and rear edges is come the alignment coronary opening that ensures to open a window.Alternatively, further Ground, the middle section part (for example, part apart from main support proximal part 17-67mm) in the main support and the portion close to distal end Divide in one or both of (for example, apart from main support distal end 0-20mm's), two sides (example opposite in the horizontal direction Such as, the front and back of face operative doctor) be respectively equipped be suitable for during be implanted into the aorta ascendens stent graft be used for pair The label of position.In this way, can further be promoted by multiple alignment marks of aorta ascendens stent graft different location pair Position precision.Wherein, the label can be made of any material that developing under X-ray, for example, Nitinol etc..Also, it can The label to be stitched or is pasted on the bracket of above-mentioned position.
In the present embodiment, the bracket 100 may include being suitable for implantation into the main support 101 of aorta ascendens and being located at The distal end of main support 101 is suitable for implantation into the first sub-stent 102 of bifurcated artery, adjacent with first sub-stent 102 And it is suitable for the second sub-stent 103 toward or into the arch of aorta.Wherein, the bifurcated artery includes unknown dry artery, Zuo Jing Any one in total artery and left subclavian artery.This example is illustrated by taking unknown dry artery as an example, and those skilled in the art answer Work as understanding, the invention is not limited thereto, is suitably changed according to patient's concrete condition to present embodiment, is also applied for other points Branch artery.Aorta ascendens stent graft is anchored on liter by the first sub-stent 102 and the second sub-stent 103 by present embodiment The suitable position of aorta, but the present invention is not limited to this, it can also be by other means by aorta ascendens stent graft anchor Be scheduled on the suitable position of aorta ascendens, for example, realized by forming the anchoring structures such as hangnail on stent graft positioning or The effect of anchoring.Therefore, in other embodiments, the bracket 100 can also only have main support 101, or only have Main support 101 and the first sub-stent 102.
In the present embodiment, the length of the main support 101 is about 35-155mm, for example, 57mm.First branch The length of frame 102 is about 45-105mm, for example, 80mm.The length of second sub-stent 103 is about 40-80mm, for example, 45mm.It will be appreciated by those skilled in the art that the invention is not limited thereto, the length of main support and the length of sub-stent can bases The aortic disease position of patient and aorta feature are appropriately arranged with, for example, the length of main support 101 can be 85mm, The length of first sub-stent 102 can be 45mm, and the length of the second sub-stent 103 can be 40mm, alternatively, main support 101 Length can be 45mm, and the length of the first sub-stent 102 can be 105mm, and the length of the second sub-stent 103 can be 80mm, The present invention is not particularly limited this.
Wherein, in the state of the aorta ascendens stent graft radial expansion, the main support 101 is cylindrical in shape or greatly Tubular is caused, diameter can be consistent along its axial direction, first can also become larger and then gradually become smaller, and can also have in its proximal part One section of horn-like structure, for example, the diameter D1 of its proximal part is about 24-48mm, for example, 30mm, the diameter D2 of distal end are About 30-50mm, for example, 40mm, wherein diameter D at maximum positionmaxIt is about 28-50mm, for example, 46mm.Equally, this field skill Art personnel should be appreciated that numerical value mentioned herein is only used for citing purpose, and the diameter at 101 both ends of main support can be according to trouble The actual conditions of person are appropriately arranged with, and the present invention is not particularly limited this.
Also, in the state of the aorta ascendens stent graft radial expansion, first sub-stent 102 is cylindrical in shape Or substantially tubular, for example, can be it is horn-like, diameter can become larger along its axial direction from its proximal part to distal end.Tool Body, the diameter d11 of the proximal part of first sub-stent 102 is about 6-16mm, for example, 10mm, the diameter d12 of distal end are About 10-26mm, for example, 18mm.It should be noted that the diameter at 102 both ends of the first sub-stent can be according to the reality of patient Situation is appropriately arranged with, and the present invention is not particularly limited this, and the first sub-stent 102, which can be, to be suitable for the first sub-stent 102 are affixed on any shape of vascular wall.Optionally, described in the state of the aorta ascendens stent graft radial expansion The ratio between diameter D2 of distal end of the diameter d11 of the proximal part of first sub-stent 102 and the main support 101 is 1:1-1:6, example Such as, 1:4.It is greater than the setting of the diameter of proximal part by the diameter of the distal end of the first sub-stent 102, is conducive to after the implants The interior leakage for being anchored on the suitable position of arch of aorta top set intra-arterial, preventing distant source.
In addition, second sub-stent 103 is cylindrical in shape in the state of the aorta ascendens stent graft radial expansion Or substantially tubular and its diameter can become larger along its axial direction from its proximal part to distal end, for example, the diameter of its proximal part D21 is about 25-42mm, for example, 35mm, the diameter d22 of distal end is about 25-50mm, for example, 40mm.Those skilled in the art It should be appreciated that numerical value mentioned herein is only used for citing purpose, the diameter at the both ends of second sub-stent 103 can be according to trouble The actual conditions of person are appropriately arranged with, and the present invention is not particularly limited this.Optionally, in the aorta ascendens structural transplantation In the state of object radial expansion, the distal end of the diameter d21 of the proximal part of second sub-stent 103 and the main support 101 The ratio between diameter D2 be about 1:4-1:1, for example, 3:4.
Aorta ascendens stent graft according to the present embodiment, as shown in figure 4, in minimally invasive intervention operation, Ke Yitong It crosses the first sub-stent 102 and protrudes into unknown dry artery 800, it is suitable that the aorta ascendens stent graft is limited to aorta ascendens Position, for example, the proximal part of the aorta ascendens stent graft is enabled accurately to be anchored to aortic valvular ring, stent graft On coronary artery open a window 401,402 openings that can be accurately aimed at coronary artery 901,902, in accurate reconstruction aorta petal and coronary artery On the basis of completely cut off interlayer proximal end breach or aneurysm so that interlayer vacation chamber or artery knurl thrombosis and atrophy, reach healing Purpose.In addition, in the case where aortic disease involves arch of aorta top set artery and aorta ascendens the two, using this implementation The aorta ascendens stent graft of mode can be realized by primary minimally invasive intervention operation to arch of aorta top set artery and liter The healing of both aortas, this aorta ascendens-arch of aorta integration reconstruction mode have higher stability, occur it is close, The Hazard ratio modular support graft that stent graft at a specified future date displacement causes coronary artery windowing to lose contraposition, leak in delayed etc. is more It is small.
It further, can also be by the second sub-stent 103 by institute as shown in figure 4, except through the first sub-stent 102 It states aorta ascendens stent graft and is limited to the suitable position of aorta ascendens, for example, enabling the aorta ascendens stent graft Enough secure anchorages prevent the displacement along aorta axial direction in aorta ascendens, or occur to derive from the interior leakage of distal end.This Outside, the case where aortic disease involves coronary artery, the former two or three involve in aorta ascendens and arch of aorta proximal end Under, using the aorta ascendens stent graft of present embodiment, intracavitary healing completely, tool can be realized by primary minimally invasive intervention There is higher stability, the wind that stent graft displacement close, at a specified future date causes coronary artery windowing to lose contraposition, leak in delayed etc. occurs Danger is smaller than modular support graft, meanwhile, the second sub-stent 103 toward or into the arch of aorta is further merging Frame graft rebuilds arch of aorta distal end and descending aorta provides connector.
Fig. 5 is the aorta ascendens stent graft with drum type proximal part of another embodiment according to the present invention The height H of drum type is marked in schematic elevation view.Fig. 6 is the aorta ascendens structural transplantation shown in fig. 5 with drum type proximal part The overhang h of drum type is marked in another schematic elevation view of object.In order to keep attached drawing high-visible, Fig. 5, do not draw respectively in 6 Scaffolding thread and nappe.
According to the aorta ascendens stent graft of embodiment described in Fig. 5 and Fig. 6 and the embodiment party according to Fig. 1-3 The difference of the aorta ascendens stent graft of formula is one section of the close proximal part of main support 101 in drum type, to be adapted to actively The shape in arteries and veins sinus portion.Specifically, in the state of the aorta ascendens stent graft radial expansion, the nearly heart of the drum type The height H of the distance 0-50m of edge distance bracket graft proximal part, drum type are 10-30mm, also, the drum type is along the bracket Radially projecting maximum overhang h be 3-15mm, in other words, the drum type highest point is relative to baseline (the perpendicular dotted line in Fig. 6) Prominent 3-15mm.Wherein, the occurrence of H and h can be configured according to actual needs, such as according to the liter active of particular patient The anatomical structure of arteries and veins is configured.In this way, the foot of aorta petal can be provided in the proximal part of aorta ascendens stent graft Enough activity spaces, block windowing coronarius to avoid aorta petal, also to protect when intracavitary merging aorta petal again Coronary opening is stayed to provide space.In addition, the design of such shape also help the proximal part of aorta ascendens stent graft with Aortic root fitting improves stent graft to the isolation efficiency of aortic sinus implosion mouth, is conducive to aorta ascendens reconstruction.
In conclusion as shown in figure 4, covering the branch of artificial blood vessel's film according to the aorta ascendens stent graft of embodiment The effect of isolation aortic disease (interlayer cut or aortic aneurysm) is erected, can be straight barrel type, can also be branch type.So-called bifurcated Type is distally there are two branch, and long leg (i.e. the first sub-stent 102) is placed in inside truncus brachiocephalicus artery (i.e. unknown dry artery), Short-leg (i.e. the second sub-stent 103) rebuilds the arch of aorta against the arch of aorta, convenient for the subsequent stent graft that further connects;Bracket Proximal part is sewed with biological aorta petal, for rebuilding aorta petal;Artificial blood vessel's film is carried out in corresponding site coronarius Windowing is supplied for retaining coronary blood.
Fig. 7 is the stereoscopic schematic diagram of the aorta ascendens stent graft of another embodiment according to the present invention.Fig. 8 is The excision of aorta ascendens stent graft shown in Fig. 7 is located at the schematic top plan view after the first sub-stent outside main support.Fig. 9 It is to show the schematic diagram of the aorta ascendens stent graft implantation endovascular situation of aorta ascendens of Fig. 7.In order to keep attached drawing clear It is clear as it can be seen that not drawing scaffolding thread and nappe in Fig. 7-9 respectively.
In the embodiment of the invention, as shown in FIG. 7 and 8, aorta ascendens stent graft may include main support 201, the first sub-stent 202 and inner support 203.Although being not shown, however, those skilled in the art should understand that, the aorta ascendens Stent graft further includes the artificial blood vessel's film being covered on these brackets.Wherein, as shown in fig. 7, first sub-stent 202 A part and the inner support 203 be disposed side by side in the main support 201, also, the distal end of the inner support 203 with The distal end of the main support 201 flushes, i.e., substantially in a plane.Optionally, the distal end of the inner support 203 exceeds The distal end of the main support 201.As shown in figure 8, in the distal end of the main support 201, outside first sub-stent 202 Gap between the periphery of all, the described inner support 203 and the inner circumferential of the main support 201 is closed or is sealed by seal 204, So that blood cannot flow through the gap between these three brackets.In addition, being provided in the proximal part of main support 201 for rebuilding The leaflet 700 of aorta petal can have in the proximal part close to the main support 201 and be suitable for two windowings coronarius of alignment 601、602。
As shown in figure 9, aorta ascendens stent graft according to the present embodiment, in minimally invasive intervention operation, first point Bracket 202 is adapted to enter into unknown dry artery 800, by being arranged the structure of sub-stent 202, inner support 203 in main support 201, Main support 201 can be made to be preferably bonded vascular wall, so that the proximal part of the aorta ascendens stent graft can be accurate It is anchored to aortic valvular ring, the coronary artery windowing 601,602 on stent graft can be accurately aimed at the opening of coronary artery 901,902, Completely cut off interlayer proximal end breach or aneurysm on the basis of accurate reconstruction aorta petal and coronary artery, so that interlayer vacation chamber or dynamic Arteries and veins knurl thrombosis and atrophy, reach healing purpose.Compared with embodiment shown in Fig. 4, due to being arranged in main support 201 Sub-stent 202, inner support 203 can make main support 201 be preferably bonded vascular wall, to the disease for involving aorta ascendens intermediate region Become, such as aortic aneurysm, there is better therapeutic effect.
Although being illustrated above in conjunction with attached drawing to various different embodiments of the invention, in order to make this The feature, advantage of invention etc. is more obvious, below with reference to Figure 10 to the aorta ascendens stent graft of embodiment of the present invention Results of animal is illustrated.
Inventor's early period has carried out zoopery using healthy adult domestic pig (60-65 kilograms).Firstly, inventor is to domestic pig It carries out aorta CT angiography (CTA) to check, after specifying its aortic root anatomical structure, makes aorta ascendens structural transplantation Object, configuration are as follows: proximal part is sewed with biology aorta petal made of bovine pericardium;By proximal part, there are two windowings, it is therefore an objective to protect Stay left and right coronary ostium;Distal end is branch type, there is a long leg (i.e. the first sub-stent), quasi- to be placed in truncus brachiocephalicus intra-arterial, Since the ascending aortic segment of pig is very short, only less than 2cm, so, another short-leg (i.e. the second sub-stent) only retains an opening, right Aortic arch;The main body of stent graft is tubular structure.In actual experiment, under general anesthesia, small notch dissects Pigs Hearts Sharp (the picture A in Figure 10), after radiography clearly left and right coronary ostium angles and positions (picture B, C in Figure 10), carefully Point imports stent graft, after ensuring that axial and circumferential positioning can well retain coronary artery (picture D in Figure 10), release Stent graft, then, the position of radiography combination esophagus sonographic evaluation stent graft, the function of aorta petal, coronary artery Unobstructed situation etc. (picture E-J in Figure 10).(picture K in Figure 10) is confirmed through zoopery follow-up period aorta CTA, using this Aorta ascendens stent graft, can minimally invasive intracavitary reconstruction aortic root (including aorta petal) and aorta ascendens, retain it is left, Arteria coronaria dextra, while connector is provided for further reconstruction aortic arch and descending aorta.It is suitable for solving following disease Disease: involve aortic sinus, coronary ostium, the aorta dissection of aorta petal and aortic aneurysm, aorta petal and seriously close Incomplete or Serious Stenosis is closed with Ascending Aortic Aneurysm etc..
Figure 11 is to show the aorta ascendens branch with horn-like proximal part of another embodiment according to the present invention Frame graft is implanted into the schematic diagram of aorta ascendens blood vessel and the situation in left ventricular outflow tract view.Shown in present embodiment and Fig. 1-4 The difference of embodiment is that the proximal part of the stent graft shown in Fig. 1-4 increases by one section of horn-like structure.In other words It says, in the aorta ascendens stent graft shown in Figure 11, in the state of radial expansion, the nearly heart of the stent graft End is horn-like structure.Nearly heart edge 0-40mm of the proximal part of the horn-like structure apart from the leaflet, that is, extend into left room In efferent tract, also, the bore of the proximal part of the horn-like structure is 22-48mm.
It optionally, can also be in the close of the stent graft on the basis of embodiment shown in Fig. 5-6, Fig. 7-9 Heart end increases by one section of horn-like structure.
The horn-like structure is adapted to extend into inside the left ventricular outflow tract view of heart, and the beneficial effect of anchor supports may be implemented Fruit.It will be appreciated by those skilled in the art that the present invention is not limited to use horn-like structure the bore of its proximal part can be used slightly Greatly, the then structure of diminishing any shape.
Skilled person should be appreciated that disclosed above is only embodiments of the present invention, certainly cannot be with This interest field to limit the present invention still belongs to the claims in the present invention institute according to equivalent variations made by embodiment of the present invention The range covered.

Claims (25)

1. a kind of aorta ascendens stent graft characterized by comprising
Bracket;
At least partly cover the nappe of the bracket;
For rebuilding the leaflet of aorta petal, the leaflet be arranged in the proximal part of the bracket and with the nappe and branch Frame connection.
2. aorta ascendens stent graft as described in claim 1, which is characterized in that the bracket includes being suitable for implantation into liter It the main support of aorta and is suitable for implantation into positioned at the distal end of main support to the first sub-stent of bifurcated artery.
3. aorta ascendens stent graft as claimed in claim 2, which is characterized in that the length of the main support is 35- 155mm。
4. aorta ascendens stent graft as claimed in claim 2, which is characterized in that the length of first sub-stent is 45-105mm。
5. aorta ascendens stent graft as claimed in claim 2, which is characterized in that in the aorta ascendens stent graft In the state of radial expansion, the main support is 22-48mm in the substantially diameter of tubular and its proximal part, and the diameter of distal end is 30-50mm。
6. aorta ascendens stent graft as claimed in claim 5, which is characterized in that the diameter of the main support is along its axial direction It first becomes larger and then gradually becomes smaller from its proximal part to distal end, wherein maximum gauge 28-50mm.
7. aorta ascendens stent graft as claimed in claim 2, which is characterized in that in the aorta ascendens stent graft In the state of radial expansion, first sub-stent is 6-16mm in the substantially diameter of tubular and its proximal part, distal end it is straight Diameter is 10-26mm.
8. aorta ascendens stent graft as claimed in claim 7, which is characterized in that the diameter of first sub-stent is along it It is axial to be become larger from its proximal part to distal end.
9. aorta ascendens stent graft as claimed in claim 2, which is characterized in that in the aorta ascendens stent graft In the state of radial expansion, the diameter ratio of the diameter and the distal end of the main support of the proximal part of first sub-stent is 1:1-1:6。
10. aorta ascendens stent graft as claimed in claim 2, which is characterized in that the bracket further includes and described One sub-stent is adjacent and suitable for the second sub-stent toward or into the arch of aorta.
11. aorta ascendens stent graft as claimed in claim 10, which is characterized in that the length of second sub-stent is 40-80mm。
12. aorta ascendens stent graft as claimed in claim 10, which is characterized in that in the aorta ascendens structural transplantation In the state of object radial expansion, second sub-stent is 25-42mm in the substantially diameter of tubular and its proximal part, distal end Diameter is 25-50mm.
13. aorta ascendens stent graft as claimed in claim 12, which is characterized in that the diameter edge of second sub-stent Its axial direction becomes larger from its proximal part to distal end.
14. aorta ascendens stent graft as claimed in claim 10, which is characterized in that in the aorta ascendens structural transplantation In the state of object radial expansion, the diameter ratio of the distal end of the diameter and main support of the proximal part of second sub-stent For 1:4-1:1.
15. aorta ascendens stent graft as described in claim 1, which is characterized in that the leaflet is in the bracket Portion is sewn on the bracket and nappe.
16. aorta ascendens stent graft as described in claim 1, which is characterized in that the proximal part close to the bracket has There are two the windowings for being suitable for being aligned two coronary ostiums.
17. aorta ascendens stent graft as claimed in claim 16, which is characterized in that the nearly heart edge setting of the windowing exists At proximal part 5-50mm away from bracket.
18. aorta ascendens stent graft as claimed in claim 16, which is characterized in that in the horizontal direction of the windowing Opposite edge is respectively equipped with the label being suitable for during being implanted into the aorta ascendens stent graft for contraposition.
19. aorta ascendens stent graft as claimed in claim 18, which is characterized in that in the middle section part of the main support With at least one of part of distal end, two sides opposite in the horizontal direction are respectively equipped with is suitable for described in the implantation Label during aorta ascendens stent graft for contraposition.
20. aorta ascendens stent graft as described in claim 1, which is characterized in that in the aorta ascendens structural transplantation In the state of object radial expansion, the aorta ascendens stent graft is in drum type close to one section of proximal part.
21. aorta ascendens stent graft as claimed in claim 20, which is characterized in that the nearly heart edge distance branch of the drum type Frame graft proximal part 0-50mm.
22. aorta ascendens stent graft as claimed in claim 20, which is characterized in that in the aorta ascendens structural transplantation In the state of object radial expansion, the height of the drum type is 10-30mm, also, the drum type is along the radially projecting of the bracket Maximum overhang is 3-15mm.
23. aorta ascendens stent graft as claimed in claim 2, which is characterized in that further include inner support;
A part of first sub-stent and the inner support are disposed side by side in the main support, the telecentricity of the inner support End and the distal end of the main support are substantially in a plane or the distal end of the inner support is beyond the remote of the main support Heart end;Also, in the distal end of the main support, the periphery of first sub-stent, the periphery of the inner support and the master Gap between the inner circumferential of bracket is sealed by seal.
24. aorta ascendens stent graft as described in claim 1, which is characterized in that in the aorta ascendens structural transplantation In the state of object radial expansion, the proximal part outer surface of the stent graft is horn-like structure.
25. aorta ascendens stent graft as claimed in claim 24, which is characterized in that the proximal part of the horn-like structure Nearly heart edge apart from the leaflet is 0-40mm, also, the bore of the proximal part of the horn-like structure is 22-48mm.
CN201810379341.2A 2018-04-25 2018-04-25 Aorta ascendens stent graft Pending CN109091271A (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CN201810379341.2A CN109091271A (en) 2018-04-25 2018-04-25 Aorta ascendens stent graft
JP2021508038A JP2021522037A (en) 2018-04-25 2018-11-19 Ascending aorta stent graft
EP18915822.3A EP3785665A4 (en) 2018-04-25 2018-11-19 Ascending aortic stent graft
PCT/CN2018/116151 WO2019205599A1 (en) 2018-04-25 2018-11-19 Ascending aortic stent graft
US17/050,634 US20210244525A1 (en) 2018-04-25 2018-11-19 Ascending aortic stent graft

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Application Number Priority Date Filing Date Title
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Application publication date: 20181228