WO2019205599A1 - 升主动脉支架移植物 - Google Patents

升主动脉支架移植物 Download PDF

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Publication number
WO2019205599A1
WO2019205599A1 PCT/CN2018/116151 CN2018116151W WO2019205599A1 WO 2019205599 A1 WO2019205599 A1 WO 2019205599A1 CN 2018116151 W CN2018116151 W CN 2018116151W WO 2019205599 A1 WO2019205599 A1 WO 2019205599A1
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WO
WIPO (PCT)
Prior art keywords
stent
stent graft
ascending
aortic
proximal end
Prior art date
Application number
PCT/CN2018/116151
Other languages
English (en)
French (fr)
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
Original Assignee
上海长海医院
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.)
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Publication date
Priority claimed from CN201810379341.2A external-priority patent/CN109091271A/zh
Priority claimed from CN201820600490.2U external-priority patent/CN209253227U/zh
Application filed by 上海长海医院 filed Critical 上海长海医院
Priority to JP2021508038A priority Critical patent/JP2021522037A/ja
Priority to EP18915822.3A priority patent/EP3785665A4/en
Priority to US17/050,634 priority patent/US20210244525A1/en
Publication of WO2019205599A1 publication Critical patent/WO2019205599A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2002/065—Y-shaped blood vessels
    • A61F2002/067—Y-shaped blood vessels modular
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a treatment for ascending aortic dissection and aortic aneurysm involving aortic sinus, coronary artery opening, aortic valve, aortic stenosis or regurgitation with aortic aneurysm Ascending aortic stent grafts.
  • Aortic dissection refers to the high-speed and high-pressure blood flow in the aorta through the intimal tearing hole on the aortic wall into the outer layer of the middle membrane or the epicardium junction, thereby forming the true and false aorta of the aorta and extending axially along the aorta. It can cause aortic rupture or branch artery ischemia (infarction, cerebral infarction, visceral or lower limb ischemia), etc., which is one of the most serious diseases involving the aorta.
  • Aortic aneurysm refers to the pathological expansion of the aorta, which exceeds 50% of the diameter of normal blood vessels. It can occur in the aortic sinus, ascending aorta, aortic arch, thoracic descending aorta, thoracic and abdominal aorta, abdominal aorta, etc. A rupture can cause sudden death. Aortic aneurysms located in the ascending aorta often involve the aortic sinus, causing aortic annulus deformation, separation of the leaflets and aortic valve regurgitation, and long-term effects of heart failure.
  • aortic dissection and aortic aneurysm are implanted to isolate the proximal rupture, false lumen and The aneurysm is thrombusized and shrunk, and the true cavity of the dissection is dilated for the purpose of healing.
  • this treatment method does not require chest opening, blood transfusion and extracorporeal circulation, and is simple and minimally invasive and effective.
  • Embodiments of the present invention provide an ascending aortic stent graft suitable for minimally invasive intraluminal treatment of aortic root lesions, comprising: a stent; a covering at least partially covering the stent; and a reconstruction of the aortic valve A leaflet, the leaflet being disposed at a proximal end of the stent and coupled to the cover and the stent.
  • the stent graft has two fenestrations adapted to align the two coronary artery openings.
  • An ascending aortic stent graft according to the present embodiment with a leaflet reconstructing the aortic valve, the leaflet being adapted to allow blood from the left ventricle to flow into the aorta and prevent blood from flowing back from the aorta to the left ventricle. Therefore, for aortic lesions involving the aortic root, minimally invasive endovascular treatment can be used to implant the ascending aortic stent graft into the aortic annulus to the ascending aortic root, repair the ascending aortic lesion, and reconstruct the aortic valve. To achieve the purpose of healing.
  • the stent comprises a primary stent adapted for implantation into the ascending aorta and a first sub-stent adapted to be implanted into the branch artery at a telecentric end of the primary stent.
  • the branch arteries include, but are not limited to, an anonymous stem artery, a left common carotid artery, and a left subclavian artery.
  • the ascending aorta stent graft in the minimally invasive interventional procedure, can be limited to a suitable position of the ascending aorta by the first sub-stent, for example, the ascending aorta
  • the proximal end of the stent graft can be accurately anchored to the aortic annulus, and the coronary fenestration on the stent graft can accurately align the coronary opening and isolate the proximal end of the dissection based on accurate reconstruction of the aortic valve and coronary artery.
  • a fissure or an aneurysm causes the dissection of the false lumen or aneurysm to atrophy and atrophy for the purpose of healing.
  • the ascending aortic stent graft of the present embodiment can achieve the branch artery and the augmentation of the aortic arch by minimally invasive surgery in one cavity.
  • the healing of the arteries, the ascending aorta-aortic arch integrated reconstruction mode has higher stability, and the risk of coronary fenestration loss of alignment, delayed endoleak, etc. occurs due to the displacement of proximal and long-term stent grafts. Smaller than a combined stent graft.
  • the main stent in the state in which the ascending aorta stent graft is radially expanded, is substantially cylindrical, about 35-155 mm long, and has a diameter of 22- near the proximal end. 48mm, the diameter of the telecentric end is 30-50mm.
  • the diameter of the main bracket may be uniform from the proximal end to the distal end of the main support along the axial direction thereof, or may be gradually enlarged and then gradually reduced, or may have a trumpet-like structure at the proximal end thereof, wherein The main bracket has a maximum diameter of 28-50 mm.
  • the ascending aorta stent graft facilitates anchoring to a suitable position within the aorta after implantation based on its radially expanded configuration.
  • the first sub-stent in a state in which the ascending aorta stent graft is radially expanded, is substantially cylindrical and has a diameter of 6-16 mm at a proximal end and a diameter of 10 at a distal end. -26mm.
  • the first sub-bracket is flared, that is, the diameter of the first sub-bracket can be gradually increased from its proximal end to the telecentric end along its axial direction.
  • the diameter of the distal end of the first sub-stent is larger than the diameter of the proximal end, which facilitates anchoring to a suitable position in the branch artery of the aortic arch after implantation, preventing the occurrence of distal The end leak of the end source.
  • the ascending aorta stent graft further includes an inner stent; a portion of the first sub-stent and the inner stent are disposed side by side in the main stent, the inner stent
  • the telecentric end is substantially in a plane with the telecentric end of the main stent, or the telecentric end of the inner stent extends beyond the telecentric end of the main stent; and, at the telecentric end of the main stent,
  • the outer circumference of the first sub-bracket, the outer circumference of the inner bracket, and the inner circumference of the main bracket are sealed by a sealing body.
  • the main stent portion can be better fitted to the blood vessel wall and anchored at an appropriate position, involving the ascending aorta Lesions in the middle region, such as aortic aneurysms, have a better therapeutic effect.
  • the stent further includes a second sub-stent adjacent the first sub-stent and adapted to or toward the aortic arch.
  • the ascending aortic stent graft of the present embodiment in the minimally invasive interventional procedure, in addition to the first sub-stent, the ascending aortic stent graft can be limited to the appropriate position of the ascending aorta by the second sub-stent.
  • the ascending aortic stent graft can be securely anchored to the ascending aorta, preventing displacement, or endoleaking from the distal end.
  • the ascending aortic stent graft of the present embodiment can be achieved by minimal intracavitary invasiveness.
  • Complete intracavitary cure, with higher stability, the risk of loss of alignment, delayed endoleak, etc. caused by proximal and long-term stent graft displacement is smaller than that of combined stent grafts.
  • Further placement of the stent graft in the second sub-stent reconstructs the distal end of the aortic arch and the descending aorta provides an articulation segment.
  • a second sub-stent toward or into the aortic arch provides an articulation for further placement of the stent graft to reconstruct the distal aortic arch and the descending aorta.
  • the second sub-stent is substantially cylindrical and has a diameter of 25-42 mm at a proximal end and a diameter of 25-50 mm at a distal end.
  • the diameter of the second sub-bracket gradually increases from its proximal end to the telecentric end along its axial direction.
  • the diameter of the distal end of the second sub-stent is larger than the diameter of the proximal end, further contributing to anchoring in the aorta after implantation to prevent the occurrence of distal The end leak of the end source.
  • the fenestration is disposed 5-50 mm from the proximal end of the stent.
  • the opposite edges in the horizontal direction of the fenestration are respectively provided with indicia suitable for alignment during implantation of the ascending aortic stent graft.
  • the markers developed under X-rays disposed at the front and rear edges of the fenestration overlap to ensure that the window is aligned with the coronary artery. Opening.
  • the opposite sides in the horizontal direction are respectively provided to be adapted to implant the ascending aortic stent graft
  • the mark used to align the bits in the process is respectively provided to be adapted to implant the ascending aortic stent graft. In this way, the alignment accuracy can be further improved by multiple alignment marks at different positions of the ascending aortic stent graft.
  • the section of the ascending aorta stent graft near the proximal end is drum-shaped.
  • the distance from the proximal edge of the drum to the proximal edge of the bracket is 0-50 mm, and the maximum protrusion of the drum along the radial direction of the bracket is 3-15 mm, the drum height It is 10-30mm.
  • aortic valve can be provided in the proximal end of the ascending aortic stent graft to avoid occlusion of the aortic valve to the fenestration of the coronary artery.
  • a shape design is also conducive to the proximal end of the ascending aortic stent graft and the aortic root, which is conducive to the reconstruction of the ascending aorta.
  • the proximal end surface of the stent graft has a trumpet shape, that is, the caliber of the proximal end is slightly larger, and then gradually decreases.
  • the length of the trumpet structure is 0-40 mm, and the trumpet shape
  • the near-heart port diameter of the structure is 22-48 mm.
  • the ascending aorta stent graft of the present invention is capable of minimally invasive treatment of aortic root lesions, for example, an aortic sinus, a coronary anastomosis, an aortic dissection of the aortic valve, and an aortic aneurysm, Aortic stenosis or dysfunction with aortic aneurysm or / and aortic dissection.
  • aortic root lesions for example, an aortic sinus, a coronary anastomosis, an aortic dissection of the aortic valve, and an aortic aneurysm, Aortic stenosis or dysfunction with aortic aneurysm or / and aortic dissection.
  • FIG. 1 is a front elevational view of an ascending aortic stent graft in accordance with an embodiment of the present invention.
  • FIG. 2 is a top plan view of an ascending aorta stent graft in accordance with an embodiment of the present invention.
  • FIG 3 is a bottom plan view of an ascending aorta stent graft in accordance with an embodiment of the present invention.
  • FIG. 4 is a schematic view showing a state in which the ascending aorta stent graft shown in FIG. 1 is implanted into an ascending aorta.
  • FIG. 5 is a front elevational view of a ascending aortic stent graft having a drum-type proximal end, labeled with a height H of the drum, in accordance with another embodiment of the present invention.
  • Figure 6 is another front elevational view of the ascending aortic stent graft having a drum-type proximal end shown in Figure 5, labeled with the amount of protrusion h of the drum.
  • FIG. 7 is a perspective schematic view of an ascending aortic stent graft in accordance with another embodiment of the present invention.
  • Figure 8 is a top plan view of the ascending aorta stent graft of Figure 7 after removal of the first sub-stent outside the main stent.
  • Fig. 9 is a schematic view showing a state in which the ascending aorta stent graft shown in Fig. 7 is implanted into the ascending aorta.
  • Fig. 10 is a collection of photographs showing experimental results of an experiment in which an ascending aorta stent graft is implanted into an animal according to an embodiment of the present invention.
  • FIG. 11 is a schematic view showing a situation in which a ascending aortic stent graft having a flared proximal end is implanted into an ascending aorta according to another embodiment of the present invention.
  • substantially cylindrical includes “cylindrical” and “shape similar to, similar to, similar to, or similar to a cylinder", and the sentence “substantially in one plane” is included in the description. A situation in a plane and a situation that approximates a plane.
  • FIG. 1 is a front elevational view of an ascending aortic stent graft in accordance with an embodiment of the present invention.
  • 2 is a top plan view of an ascending aorta stent graft in accordance with an embodiment of the present invention.
  • 3 is a bottom plan view of an ascending aorta stent graft in accordance with an embodiment of the present invention.
  • the bottom is the proximal side (end) and the top is the telecentric side (end).
  • the ascending aortic stent graft can include a stent 100, a covering 200 covering the stent 100, a leaflet 300 for reconstructing the aortic valve, and a fenestration 401 aligned with the two coronary arteries. 402.
  • the leaflet 300 is disposed at a proximal end of the stent 100 and is coupled to the covering body 200 and the stent 100.
  • the leaflet 300 may be sewn on the covering body 200 and the stent 100.
  • the leaflet 300 causes blood from the left ventricle to flow into the aorta and prevent blood from flowing back from the aorta to the left ventricle.
  • the stent 100 covered by the covering body 200 is shown in the drawing.
  • the stent 100 serves as a supporting structure or skeleton of the ascending aorta stent graft, and may be composed of a stent wire. Specifically, it may be woven from a metal wire or a self-expanding nickel-titanium alloy stent.
  • the covering body 200 may be an artificial blood vessel membrane.
  • the bracket 100 and the cover 200 may be sewn together by non-absorbable sutures, or may be integrally joined by heat pressing, bonding or the like.
  • the leaflet 300 may be a biological flap made of a biological material such as a bovine pericardium, a pig pericardium, or a pericardium, and the number of the flaps may be three. After the three leaflets are sewn on the covering body and the bracket, the shapes are respectively A "pocket" that encloses three aortic sinuses.
  • the ascending aorta stent graft may have fenestrations 401, 402 adapted to align two coronary artery openings at a proximal end of the stent 100.
  • the proximal edge of the fenestration is disposed at a distance of 5-50 mm from the proximal end of the stent 100, for example, 15 mm from the proximal end of the stent 100, 25 mm, 35 mm, etc., depending on the patient's
  • the structure of the arterial blood vessels is appropriately set.
  • the proximal edge of the fenestration 401 is 25 mm from the proximal end of the stent graft and the proximal edge of the fenestration 402 is 27.5 mm from the proximal end of the stent graft.
  • the fenestration can be customized before surgery, or can be temporarily opened on the operating table during surgery, that is, a part of the covering at the coronary artery is removed, so that the inside of the stent is removed. Connected with coronary blood flow.
  • the covering 200 can partially cover the stent 100, ie, the stent 100 is not covered at the alignment of the coronary artery, which can also allow the interior of the stent to communicate with the coronary blood flow.
  • the edges that are opposite in the horizontal direction of the fenestration may each be provided with a procedure suitable for implantation of the ascending aortic stent graft Used to mark the alignment.
  • the markers developed under X-rays disposed at the front and rear edges of the fenestration overlap to ensure that the window is aligned with the coronary artery. Opening.
  • the opposite sides in the horizontal direction are respectively provided for alignment during implantation of the ascending aortic stent graft. mark.
  • the mark may be made of any material developed under X-rays, for example, a nickel titanium alloy or the like. Also, the mark may be sewn or affixed to the holder at the above position.
  • the stent 100 may include a main stent 101 adapted to be implanted into the ascending aorta and a first sub-stent 102 adapted to be implanted into the branch artery at the distal end of the main stent 101, with the The first sub-stent 102 is adjacent and adapted to face or enter the second sub-stent 103 of the aortic arch.
  • the branch artery includes any one of an anonymous dry artery, a left common carotid artery and a left subclavian artery. This example is described by taking an anonymous arteries as an example.
  • the present invention is not limited thereto, and the present embodiment is appropriately changed according to the specific conditions of the patient, and is also applicable to other branch arteries.
  • the ascending aorta stent graft is anchored at a suitable position of the ascending aorta by the first sub-stent 102 and the second sub-stent 103.
  • the present invention is not limited thereto, and the ascending aorta stent may be otherwise used.
  • the graft is anchored at a suitable location in the ascending aorta, for example, by anchoring structures such as barbs on the stent graft to achieve positioning or anchoring. Therefore, in other embodiments, the bracket 100 may also have only the main bracket 101 or only the main bracket 101 and the first sub-bracket 102.
  • the length of the main bracket 101 is about 35-155 mm, for example, 57 mm.
  • the first sub-bracket 102 has a length of about 45-105 mm, for example, 80 mm.
  • the second sub-bracket 103 has a length of about 40-80 mm, for example, 45 mm. It should be understood by those skilled in the art that the present invention is not limited thereto, and the length of the main stent and the length of the sub-bracket may be appropriately set according to the position of the aortic lesion of the patient and the characteristics of the aorta.
  • the length of the main stent 101 may be 85 mm
  • the length of the one-station bracket 102 may be 45 mm
  • the length of the second sub-bracket 103 may be 40 mm
  • the length of the main bracket 101 may be 45 mm
  • the length of the first sub-frame 102 may be 105 mm
  • the length of the second sub-frame 103 It may be 80 mm, and the present invention is not particularly limited thereto.
  • the main stent 101 in the state in which the ascending aorta stent graft is radially expanded, has a cylindrical shape or a substantially cylindrical shape, and the diameter thereof may be uniform along the axial direction thereof, or may gradually become larger and then gradually become smaller. It may also have a trumpet-like structure at its proximal end, for example, its proximal end diameter D1 is about 24-48 mm, for example, 30 mm, and the telecentric end diameter D2 is about 30-50 mm, for example, 40 mm, wherein The diameter D max at the largest portion is about 28-50 mm, for example, 46 mm.
  • the first sub-bracket 102 has a cylindrical shape or a substantially cylindrical shape, for example, may be a trumpet shape, and its diameter may be near its axial direction. From the heart to the far end, the heart gradually becomes larger. Specifically, the diameter d11 of the proximal end of the first sub-bracket 102 is about 6-16 mm, for example, 10 mm, and the diameter d12 of the telecentric end is about 10-26 mm, for example, 18 mm.
  • the diameter of the two ends of the first sub-bracket 102 can be appropriately set according to the actual situation of the patient, and the present invention is not particularly limited.
  • the first sub-bracket 102 can be adapted to attach the first sub-bracket 102 to the first sub-bracket 102. Any shape of the vessel wall.
  • a ratio of a diameter d11 of the proximal end of the first sub-stent 102 to a diameter D2 of the telecentric end of the main stent 101 is 1: 1-1:6, for example, 1:4.
  • the distal end of the first sub-stent 102 having a diameter greater than the diameter of the proximal end, it is advantageous to anchor the appropriate position within the branch artery on the aortic arch after implantation to prevent endogenous source of endoleak.
  • the second sub-stent 103 is cylindrical or substantially cylindrical and its diameter may gradually extend from its proximal end to the distal end along its axial direction.
  • the size is increased, for example, the diameter d21 of the proximal end thereof is about 25-42 mm, for example, 35 mm, and the diameter d22 of the telecentric end is about 25-50 mm, for example, 40 mm.
  • a ratio of a diameter d21 of the proximal end of the second sub-stent 103 to a diameter D2 of the telecentric end of the main stent 101 is about 1 : 4-1:1, for example, 3:4.
  • the ascending aorta stent graft of the present embodiment in the minimally invasive interventional procedure, can be limited by the first sub-stent 102 extending into the anonymous arterial artery 800.
  • Appropriate position of the ascending aorta for example, enables the proximal end of the ascending aortic stent graft to be accurately anchored to the aortic annulus, and the coronary fenestrations 401, 402 on the stent graft can accurately align with the coronary 901
  • the opening of 902 on the basis of accurately reconstructing the aortic valve and coronary artery, isolates the proximal fissure or aneurysm of the dissection, so that the dissection cavity or aneurysm is thrombusized and atrophied for the purpose of healing.
  • the ascending aortic stent graft of the present embodiment can achieve the branch artery and the ascending aorta of the aortic arch by a minimally invasive interventional procedure.
  • the healing of the two, the ascending aorta-aortic arch integrated reconstruction mode has higher stability, the risk ratio of proximal and long-term stent graft displacement causes coronary fenestration loss of alignment, delayed endoleak, etc.
  • the combined stent graft is smaller.
  • the ascending aorta stent graft may be limited to a suitable position in the ascending aorta by the second sub-stent 103, for example, such that the ascending aorta
  • the stent graft can be anchored securely to the ascending aorta, preventing displacement along the axial direction of the aorta, or endoleaking from the distal end.
  • the ascending aortic stent graft of the present embodiment can be completely achieved by a minimally invasive intervention. Intracavitary cure, with higher stability, the risk of loss of alignment of the coronary fenestration, delayed endoleak, etc.
  • the second sub-stent 103 entering the aortic arch provides a connector for further implantation of the stent graft to reconstruct the distal aortic arch and the descending aorta.
  • FIG. 5 is a front elevational view of a ascending aortic stent graft having a drum-type proximal end, labeled with a height H of the drum, in accordance with another embodiment of the present invention.
  • Figure 6 is another front elevational view of the ascending aortic stent graft having a drum-type proximal end shown in Figure 5, labeled with the amount of protrusion h of the drum.
  • the stent wire and the covering body are not separately drawn in Figs.
  • the ascending aortic stent graft according to the embodiment of Figures 5 and 6 differs from the ascending aortic stent graft of the embodiment according to Figures 1-3 in that a section of the main stent 101 near the proximal end is drummed Type to fit the shape of the aortic sinus. Specifically, in a state in which the ascending aorta stent graft is radially expanded, the distance from the proximal edge of the drum to the proximal end of the stent graft is 0-50 m, and the height H of the drum is 10-30 mm.
  • the maximum protruding amount h of the drum pattern protruding in the radial direction of the bracket is 3-15 mm, in other words, the highest point of the drum pattern protrudes 3-15 mm with respect to the baseline (the vertical broken line in Fig. 6).
  • the specific values of H and h can be set according to actual needs, for example, according to the anatomy of the ascending aorta of a specific patient.
  • aortic valve can be provided in the proximal end of the ascending aortic stent graft to avoid occlusion of the aortic valve to the fenestration of the coronary artery, and to preserve the crown when the aortic valve is inserted into the aortic valve again.
  • the pulse opening provides space.
  • such a shape design is also conducive to the proximal end of the ascending aortic stent graft and the aortic root fit, improve the isolation of the stent graft on the rupture of the aortic sinus, and facilitate the reconstruction of the ascending aorta.
  • the stent covered with the artificial blood vessel membrane functions to isolate the aortic lesion (dissection or aortic aneurysm), and may be a straight type. It can also be a fork type.
  • the so-called bifurcation type has two branches at the distal end, and the long leg (ie, the first sub-stent 102) is placed inside the brachial artery of the forearm (ie, the nameless trunk artery), and the short leg (ie, the second sub-bracket 103) is opposite the aortic arch.
  • the bioaortic valve is sutured at the proximal end of the stent for reconstructing the aortic valve;
  • the vascular window of the artificial vascular membrane is used in the corresponding part of the coronary artery to preserve the coronary blood supply.
  • FIG. 7 is a perspective schematic view of an ascending aortic stent graft in accordance with another embodiment of the present invention.
  • Figure 8 is a top plan view of the ascending aorta stent graft of Figure 7 after removal of the first sub-stent outside the main stent.
  • Figure 9 is a schematic diagram showing the implantation of the ascending aorta stent graft of Figure 7 into the ascending aorta.
  • the stent wire and the cover are not separately drawn in Figures 7-9.
  • the ascending aorta stent graft can include a primary stent 201, a first sub-stent 202, and an inner stent 203.
  • the ascending aortic stent graft also includes an artificial vascular membrane overlying the stent.
  • a part of the first sub-bracket 202 and the inner bracket 203 are arranged side by side in the main bracket 201, and the telecentric end of the inner bracket 203 and the main bracket 201 The telecentric end is flush, that is, roughly in one plane.
  • the distal end of the inner bracket 203 extends beyond the telecentric end of the main bracket 201.
  • the outer circumference of the first sub-bracket 202, the outer circumference of the inner bracket 203, and the inner circumference of the main bracket 201 pass through a sealing body.
  • the 204 is sealed or sealed so that blood cannot flow through the gap between the three stents.
  • a leaflet 700 for reconstructing the aortic valve is provided in the proximal end of the main stent 201, and a fenestration 601, 602 adapted to align the two coronary arteries may be provided near the proximal end of the main stent 201. .
  • the first sub-stent 202 is adapted to enter the nameless trunk artery 800, and the sub-bracket 202 is sleeved in the main stent 201,
  • the structure of the inner stent 203 can make the main stent 201 better fit the blood vessel wall, so that the proximal end of the ascending aortic stent graft can be accurately anchored to the aortic annulus, and the coronary artery on the stent graft is opened.
  • the windows 601 and 602 can accurately align the openings of the coronary veins 901 and 902, and isolate the proximal end of the dissection or the aneurysm on the basis of accurately reconstructing the aortic valve and the coronary artery, so that the dissection cavity or the aneurysm is thrombotic and atrophied. Achieve the purpose of healing.
  • the main stent 201 can better conform to the blood vessel wall, and the lesion involving the middle region of the ascending aorta, for example, Aortic aneurysm has a better therapeutic effect.
  • CTA CT angiography
  • Biological aortic valve there are two open windows near the heart to preserve left and right coronary artery openings; the distal end is bifurcated, with a long leg (ie, the first sub-stent), intended to be placed in the brachiocephalic artery
  • a long leg ie, the first sub-stent
  • the other short leg ie, the second sub-stent
  • the main body of the stent graft is a cylindrical structure.
  • the ascending aortic stent graft can be used to reconstruct the aortic root (including the aortic valve) and the ascending aorta in a minimally invasive cavity, leaving the left and right.
  • the coronary arteries provide a joint for further reconstruction of the aortic arch and descending aorta. It is suitable for the treatment of aortic sinus, coronary artery opening, aortic dissection of the aortic valve and aortic aneurysm, severe aortic regurgitation or severe stenosis with ascending aortic aneurysm.
  • FIG. 11 is a schematic view showing a situation in which a ascending aortic stent graft having a flared proximal end is implanted into an ascending aorta and a left ventricular outflow tract according to another embodiment of the present invention.
  • This embodiment differs from the embodiment shown in Figures 1-4 in that a trumpet-like structure is added to the proximal end of the stent graft shown in Figures 1-4.
  • the proximal end of the stent graft is a trumpet-like structure when in a radially expanded state.
  • the proximal end of the horn-like structure is 0-40 mm from the proximal edge of the leaflet, i.e., extends into the left ventricular outflow tract, and the proximal end of the horn-like structure has a diameter of 22-48 mm.
  • a trumpet-like structure may be added to the proximal end of the stent graft.
  • the flared structure is adapted to extend into the left ventricular outflow tract of the heart, and the beneficial effect of anchoring the stent can be achieved. It will be understood by those skilled in the art that the present invention is not limited to the use of a trumpet-like structure, and a structure of any shape having a slightly larger diameter at the proximal end and then gradually decreasing may be employed.

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Abstract

一种升主动脉支架移植物，涉及医疗器械领域。升主动脉支架移植物包括：支架(100)；至少部分覆盖支架(100)的覆盖体(200)；用于重建主动脉瓣的瓣叶(300,700)，瓣叶(300,700)设置在支架(100)的近心端并且与支架(100)和覆盖体(200)连接。升主动脉支架移植物，其带有重建主动脉瓣的瓣叶(300,700)，瓣叶(300,700)适于使左心室的血液流入主动脉且阻止血液从主动脉回流至左心室；此外，支架移植物上可具有两个适于对准两个冠状动脉开口的开窗(401,402,601,602)。因此，针对同时累及了主动脉窦和主动脉瓣的主动脉根部病变，可以采用微创腔内治疗术将该升主动脉支架移植物植入升主动脉根部，修复升主动脉，重建主动脉瓣、主动脉窦、冠状动脉开口，达到一体化治愈目的。

Description

升主动脉支架移植物
相关申请的交叉引用
本申请要求于2018年4月25日提交中国国家知识产权局、申请号为201810379341.2、发明名称为“升主动脉支架移植物”的中国专利申请、以及2018年4月25日提交中国国家知识产权局、申请号为201820600490.2、发明名称为“升主动脉支架移植物”的中国专利申请的优先权，上述中国专利申请的全部内容通过引用并入本文。
技术领域
本发明涉及医疗器械技术领域，具体地，涉及一种适于治疗累及主动脉窦、冠状动脉开口、主动脉瓣的升主动脉夹层和主动脉瘤、主动脉瓣狭窄或关闭不全伴主动脉瘤等的升主动脉支架移植物。
背景技术
主动脉夹层是指主动脉内高速高压血流通过主动脉壁上的内膜撕裂口进入中膜外层或中外膜交界处，从而形成主动脉真假两腔，并沿主动脉轴向扩展，可导致主动脉破裂或分支动脉缺血(心梗、脑梗、内脏或下肢缺血)等，是累及主动脉最严重的疾病之一。既往有研究根据主动脉夹层近端裂口的部位对主动脉不同部位的夹层进行了统计：近端裂口位于升主动脉的主动脉夹层占所有主动脉夹层的65％，位于主动脉弓部的占5％，位于降主动脉的约占30％。主动脉瘤是指主动脉病理性的扩张，超过正常血管直径的50％，可发生于主动脉窦、升主动脉、主动脉弓、胸降主动脉、胸腹主动脉、腹主动脉等部位，瘤状破裂可致猝死。位于升主动脉的主动脉瘤常累及主动脉窦，使主动脉瓣环变形、瓣叶分离而致主动脉瓣关闭不全，长期影响造成心功能衰竭。
对于近端裂口及瘤体位于降主动脉、主动脉弓部和升主动脉中段1/3的主 动脉夹层和主动脉瘤，通过植入覆人工血管膜的支架移植物隔绝近端裂口，假腔和动脉瘤体血栓化而缩小，夹层真腔扩张，达到治愈目的。这种治疗方法与传统开放手术相比，无需开胸、输血及体外循环，简捷微创、疗效确切。
随着血管腔内支架移植物和技术的进步，应用支架移植物微创介入治疗主动脉夹层已从经典的降主动脉夹层，发展到已能处理除主动脉根部之外的大部分主动脉夹层和主动脉瘤。然而，对于主动脉根部病变(升主动脉瘤或升主动脉夹层、伴主动脉瓣狭窄和/或关闭不全)，目前只能采用开放外科手术治疗，如Bentall手术(采用带人造主动脉瓣的涤纶血管置换术，并将冠状动脉再植入涤纶血管)、Wheat手术等。这些开放手术方式都需要心脏停搏、体外循环，手术创伤巨大，死亡率、并发症率高。亟需一种能够微创腔内治疗主动脉根部病变的医疗器具。
发明内容
本发明的实施方式提供了一种适于微创腔内治疗主动脉根部病变的升主动脉支架移植物，其包括：支架；至少部分覆盖所述支架的覆盖体；用于重建主动脉瓣的瓣叶，所述瓣叶设置在所述支架的近心端并且与所述覆盖体和支架连接。可选地，支架移植物上具有两个适于对准两个冠状动脉开口的开窗。
根据本实施方式的升主动脉支架移植物，其带有重建主动脉瓣的瓣叶，所述瓣叶适于使左心室的血液流入主动脉且阻止血液从主动脉回流至左心室。因此，针对累及主动脉根部的主动脉病变，可以采用微创腔内治疗术将该升主动脉支架移植物植入主动脉瓣环至升主动脉根部，修复升主动脉病变，重建主动脉瓣，达到治愈目的。
在本发明的另一种实施方式中，所述支架包括适于植入至升主动脉的主支架和位于主支架的远心端的适于植入至分支动脉的第一分支架。所述分支动脉包括但不限于无名干动脉、左颈总动脉和左锁骨下动脉。
根据本实施方式的升主动脉支架移植物，在微创介入手术中，可以通过第一分支架将所述升主动脉支架移植物限定在升主动脉合适的位置，例如，使得该升主动脉支架移植物的近心端能够准确锚定于主动脉瓣环，支架移植 物上的冠脉开窗能够准确对准冠脉开口，在准确重建主动脉瓣和冠状动脉的基础上隔绝夹层近端裂口或动脉瘤，使得夹层假腔或动脉瘤体血栓化而萎缩，达到治愈目的。此外，在主动脉病变累及主动脉弓上分支动脉和升主动脉二者的情况下，采用本实施方式的升主动脉支架移植物，可以通过一次腔内微创手术实现对主动脉弓上分支动脉和升主动脉二者的治愈，这种升主动脉-主动脉弓一体化重建模式具有更高的稳定性，发生近、远期支架移植物移位造成冠脉开窗失去对位、迟发型内漏等的风险比组合式支架移植物更小。
在本发明的可选实施方式中，在所述升主动脉支架移植物径向扩展的状态下，所述主支架呈大致筒状，长约35-155mm，且其近心端的直径为22-48mm，远心端的直径为30-50mm。所述主支架的直径沿其轴向从其近心端至远心端可以一致，也可以先逐渐变大然后逐渐变小，也可在其近心端带有一段喇叭状的结构，其中，主支架最大直径为28-50mm。
根据本实施方式的升主动脉支架移植物，基于其径向扩展后的形态，有利于在植入之后锚定在主动脉内合适的位置。
进一步地，或作为选择，在所述升主动脉支架移植物径向扩展的状态下，所述第一分支架呈大致筒状且其近心端的直径为6-16mm，远心端的直径为10-26mm。例如，所述第一分支架呈喇叭状，即，所述第一分支架的直径沿其轴向从其近心端至远心端可逐渐变大。
根据实施方式的升主动脉支架移植物，通过第一分支架的远心端的直径大于近心端的直径的设置，有利于在植入之后锚定在主动脉弓上分支动脉内合适的位置、防止发生远端来源的内漏。
在本发明的另一实施方式中，所述升主动脉支架移植物还包括内支架；所述第一分支架的一部分和所述内支架并排设置在所述主支架内，所述内支架的远心端与所述主支架的远心端大致在一个平面内，或所述内支架的远心端超出所述主支架的远心端；并且，在所述主支架的远心端，所述第一分支架的外周、所述内支架的外周与所述主支架的内周之间的空隙通过密封体密封。
根据本实施方式的升主动脉支架移植物，通过在主支架内套设分支架的结构，可以使主支架部分更好地贴合血管壁，并锚定在合适的位置，对累及 升主动脉中间区域的病变，例如主动脉瘤，有更好的治疗效果。
在本发明的另一实施方式中，所述支架还包括与所述第一分支架相邻且适于朝向或进入主动脉弓的第二分支架。
根据本实施方式的升主动脉支架移植物，在微创介入手术中，除了通过第一分支架，还可以通过第二分支架将所述升主动脉支架移植物限定在升主动脉合适的位置，例如，使得该升主动脉支架移植物能够牢固锚定于升主动脉，防止发生移位，或是发生来源于远心端的内漏。此外，在主动脉病变累及冠状动脉、升主动脉和主动脉弓近端中前二者或三者都累及的情况下，采用本实施方式的升主动脉支架移植物，可以通过一次腔内微创实现完全腔内治愈，具有更高的稳定性，发生近、远期支架移植物移位造成冠脉开窗失去对位、迟发型内漏等的风险比组合式支架移植物更小，同时也为第二分支架内进一步置入支架移植物重建主动脉弓远端和降主动脉提供了衔接段。同时，朝向或进入主动脉弓的第二分支架为进一步置入支架移植物重建主动脉弓远端和降主动脉提供了衔接段。
可选地，在所述升主动脉支架移植物径向扩展的状态下，所述第二分支架呈大致筒状且其近心端的直径为25-42mm，远心端的直径为25-50mm。所述第二分支架的直径沿其轴向从其近心端至远心端逐渐变大。
根据实施方式的升主动脉支架移植物，通过第二分支架的远心端的直径大于近心端的直径的设置，进一步有助于在植入之后锚定在主动脉内合适的位置，防止发生远端来源的内漏。
在本发明的其他可选实施方式中，在靠近主支架的近心端具有两个适于对准两个冠状动脉的开窗。例如，所述开窗设置在距支架的近心端5-50mm处。通过在近心端设置所述开口，可以保留冠脉血供。
进一步地，在所述开窗的水平方向上相对的边缘分别设有适于在植入所述升主动脉支架移植物的过程中用于对位的标记。根据本实施方式，在植入所述升主动脉支架移植物的过程中，在冠脉切线位置，开窗的前后边缘处设置的在X射线下显影的标记重叠来确保开窗对准冠脉开口。或者，进一步地，在所述主支架的中段部分和靠近远心端的部分中的至少一个中，在水平方向上相对的两侧分别设有适于在植入所述升主动脉支架移植物的过程中用于对 位的标记。这样，可以进一步通过升主动脉支架移植物不同位置的多个对位标记来提升对位精度。
在本发明的其他可选实施方式中，在所述升主动脉支架移植物径向扩展的状态下，所述升主动脉支架移植物靠近近心端的一段呈鼓型。可选地，所述鼓型的近心缘距离支架的近心缘的距离为0-50mm，并且，该鼓型沿所述支架的径向突出的最大突出量为3-15mm，鼓型高度为10-30mm。这样，可以在升主动脉支架移植物的近心端内提供主动脉瓣的足够活动空间，以避免主动脉瓣对冠状动脉的开窗的遮挡。此外，这样的形状设计还有利于升主动脉支架移植物的近心端与主动脉根部贴合，有利于升主动脉重建。
在本发明的其他可选实施方式中，支架移植物的近心端外表面呈喇叭状，即近心端的口径稍大，然后逐渐缩小，这一喇叭状结构的长度为0-40mm，喇叭状结构的近心端口径22-48mm。
综上所述，采用本发明的升主动脉支架移植物能够腔内微创治疗主动脉根部病变，例如，累及主动脉窦、冠状动脉开口、主动脉瓣的升主动脉夹层和主动脉瘤、主动脉瓣狭窄或关闭不全伴主动脉瘤或/和主动脉夹层等。
本发明实施方式的各个方面、特征、优点等将在下文结合附图进行具体描述。根据以下结合附图的具体描述，本发明的上述方面、特征、优点等将会变得更加清楚。
附图说明
图1是根据本发明的一种实施方式的升主动脉支架移植物的正视示意图。
图2是根据本发明的一种实施方式的升主动脉支架移植物的俯视示意图。
图3是根据本发明的一种实施方式的升主动脉支架移植物的仰视示意图。
图4是示出了图1所示的升主动脉支架移植物植入升主动脉血管内的情形的示意图。
图5是根据本发明的另一种实施方式的具有鼓型近心端的升主动脉支架移植物的正视示意图，其标记了鼓型的高度H。
图6是图5所示的具有鼓型近心端的升主动脉支架移植物的另一正视示意图，其标记了鼓型的突出量h。
图7是根据本发明的另一种实施方式的升主动脉支架移植物的立体示意图。
图8是图7所示的升主动脉支架移植物的切除位于主支架外部的第一分支架后的俯视示意图。
图9是示出了图7所示的升主动脉支架移植物植入升主动脉血管内的情形的示意图。
图10是显示本发明实施方式的升主动脉支架移植物植入动物进行实验的实验结果的图片的集合。
图11是示出了根据本发明的另一种实施方式的具有喇叭状近心端的升主动脉支架移植物植入升主动脉血管内的情形的示意图。
具体实施方式
为了便于理解本发明技术方案的各个方面、特征以及优点，下面结合附图对本发明进行具体描述。应当理解，下述的各种实施方式只用于举例说明，而非用于限制本发明的保护范围。
在本文中，本领域技术人员应当理解，术语“大致筒状”包括“筒状”以及“与筒状相似、类似、接近或相像的形状”，句子“大致在一个平面内”描述情况包括在一个平面内的情形以及近似在一个平面内的情形。
图1是根据本发明的一种实施方式的升主动脉支架移植物的正视示意图。图2是根据本发明的一种实施方式的升主动脉支架移植物的俯视示意图。图3是根据本发明的一种实施方式的升主动脉支架移植物的仰视示意图。在图1中，底部为近心侧(端)，顶部为远心侧(端)。下面结合图1至图3对本发明一种实施方式提供的升主动脉支架移植物进行具体说明。
在本实施方式中，升主动脉支架移植物可以包括：支架100、覆盖所述支架100的覆盖体200、用于重建主动脉瓣的瓣叶300、以及对准两个冠状动脉的开窗401、402。其中，所述瓣叶300设置在所述支架100的近心端并且与所述覆盖体200和支架100连接，例如，所述瓣叶300可缝合在所述覆盖体200和支架100上。从而，当所述升主动脉支架移植物植入主动脉血管内，所述瓣叶300使左心室的血液流入主动脉且阻止血液从主动脉回流至左心室。
为了便于说明，在附图中示出了被覆盖体200覆盖的支架100，在本实施方式中，所述支架100作为所述升主动脉支架移植物的支撑结构或骨架，可以由支架丝构成，具体而言，可以由金属丝编织而成，也可以是自膨式镍钛合金支架。所述覆盖体200可以为人工血管膜。支架100和覆盖体200之间可以由不可吸收缝线缝合成一体，也可采用热压、粘结等方式连接为一体。所述瓣叶300可以是由诸如牛心包、猪心包、驴心包等生物材料制成的生物瓣，其数量可为三个，三个瓣叶缝在覆膜体和支架上之后，形状分别像个“兜”，从而围成三个主动脉窦。
在本实施方式中，所述升主动脉支架移植物在靠近所述支架100的近心端可具有适于对准两个冠状动脉开口的开窗401、402。例如，所述开窗的近心缘设置在距支架100的近心端5-50mm处，例如，设置在距支架100的近心端15mm处、25mm处、35mm处等，具体可以根据患者的动脉血管的结构进行适当设置。例如，开窗401的近心缘距离支架移植物的近心端25mm，开窗402的近心缘距离支架移植物的近心端27.5mm。这样，可以保留冠脉供血。需说明的是，本领域技术人员应当理解，所述开窗可以术前定制成型，也可为术中在手术台上临时开窗，即将对准冠状动脉处的部分覆盖体去除，使得支架内部与冠状动脉血流相通。在其他实施方式中，覆盖体200可以部分覆盖支架100，即在对准冠状动脉处不覆盖支架100，这也可以使得支架内部与冠状动脉血流相通。
在其他可选实施方式中，可以在所述开窗的水平方向上相对的边缘(例如，正对手术医生的前后边缘)分别设有适于在植入所述升主动脉支架移植物的过程中用于对位的标记。根据本实施方式，在植入所述升主动脉支架移植物的过程中，在冠脉切线位置，开窗的前后边缘处设置的在X射线下显影的标记重叠来确保开窗对准冠脉开口。或者，更进一步地，在所述主支架的中段部分(例如，距离主支架近心端17-67mm的部分)和靠近远心端的部分(例如，距离主支架远心端0-20mm的)中的一者或两者中，在水平方向上相对的两侧(例如，正对手术医生的前后)分别设有适于在植入所述升主动脉支架移植物的过程中用于对位的标记。这样，可以进一步通过升主动脉支架移植物不同位置的多个对位标记来提升对位精度。其中，所述标记可以由在 X射线下显影的任何材料制成，例如，镍钛合金等。并且，可以将所述标记缝或粘贴在上述位置的支架上。
在本实施方式中，所述支架100可以包括适于植入至升主动脉的主支架101和位于主支架101的远心端的适于植入至分支动脉的第一分支架102、与所述第一分支架102相邻且适于朝向或进入主动脉弓的第二分支架103。其中，所述分支动脉包括无名干动脉、左颈总动脉和左锁骨下动脉中任意一者。本例以无名干动脉为例进行说明，本领域技术人员应当理解，本发明不限于此，根据患者具体情况对本实施方式进行适当变化，也适用于其他分支动脉。本实施方式通过第一分支架102和第二分支架103将升主动脉支架移植物锚定在升主动脉合适的位置，但本发明不局限于此，也可以通过其他方式将升主动脉支架移植物锚定在升主动脉合适的位置，例如，通过在支架移植物上形成倒刺等锚定结构来实现定位或锚定的作用。因此，在其他实施方式中，所述支架100也可以只具有主支架101，或者只具有主支架101和第一分支架102。
在本实施方式中，所述主支架101的长度为约35-155mm，例如，57mm。所述第一分支架102的长度为约45-105mm，例如，80mm。所述第二分支架103的长度为约40-80mm，例如，45mm。本领域技术人员应当理解，本发明不限于此，主支架的长度和分支架的长度可以根据患者的主动脉病变位置和主动脉特点进行适当设置，例如，主支架101的长度可以为85mm，第一分支架102的长度可以为45mm，第二分支架103的长度可以为40mm，或者，主支架101的长度可以为45mm，第一分支架102的长度可以为105mm，第二分支架103的长度可以为80mm，本发明对此不作特别限定。
其中，在所述升主动脉支架移植物径向扩展的状态下，所述主支架101呈筒状或大致筒状，其直径沿其轴向可以一致，也可以先逐渐变大然后逐渐变小，也可在其近心端带有一段喇叭状的结构，例如，其近心端的直径D1为约24-48mm，例如，30mm，远心端的直径D2为约30-50mm，例如，40mm，其中，最大部位处直径D max为约28-50mm，例如，46mm。同样，本领域技术人员应当理解，这里提到的数值仅用于举例目的，所述主支架101两端的直径可以根据患者的实际情况进行适当设置，本发明对此不作特别限 定。
并且，在所述升主动脉支架移植物径向扩展的状态下，所述第一分支架102呈筒状或大致筒状，例如，可以为喇叭状，其直径可以沿其轴向从其近心端至远心端逐渐变大。具体地，所述第一分支架102的近心端的直径d11为约6-16mm，例如，10mm，远心端的直径d12为约10-26mm，例如，18mm。需说明的是，所述第一分支架102两端的直径可以根据患者的实际情况进行适当设置，本发明对此不作特别限定，第一分支架102可以是适于将第一分支架102贴于血管壁的任何形状。可选地，在所述升主动脉支架移植物径向扩展的状态下，所述第一分支架102的近心端的直径d11与所述主支架101的远心端的直径D2之比为1:1-1:6，例如，1:4。通过第一分支架102的远心端的直径大于近心端的直径的设置，有利于在植入之后锚定在主动脉弓上分支动脉内合适的位置、防止发生远端来源的内漏。
此外，在所述升主动脉支架移植物径向扩展的状态下，所述第二分支架103呈筒状或大致筒状且其直径可以沿其轴向从其近心端至远心端逐渐变大，例如，其近心端的直径d21为约25-42mm，例如，35mm，远心端的直径d22为约25-50mm，例如，40mm。本领域技术人员应当理解，这里提到的数值仅用于举例目的，所述第二分支架103的两端的直径可以根据患者的实际情况进行适当设置，本发明对此不作特别限定。可选地，在所述升主动脉支架移植物径向扩展的状态下，所述第二分支架103的近心端的直径d21与所述主支架101的远心端的直径D2之比为约1:4-1:1，例如，3:4。
根据本实施方式的升主动脉支架移植物，如图4所示，在微创介入手术中，可以通过第一分支架102伸入无名干动脉800，将所述升主动脉支架移植物限定在升主动脉合适的位置，例如，使得该升主动脉支架移植物的近心端能够准确锚定于主动脉瓣环，支架移植物上的冠脉开窗401、402能够准确对准冠脉901、902的开口，在准确重建主动脉瓣和冠状动脉的基础上隔绝夹层近端裂口或动脉瘤，使得夹层假腔或动脉瘤体血栓化而萎缩，达到治愈目的。此外，在主动脉病变累及主动脉弓上分支动脉和升主动脉二者的情况下，采用本实施方式的升主动脉支架移植物，可以通过一次微创介入手术实现对主动脉弓上分支动脉和升主动脉二者的治愈，这种升主动脉-主动脉弓一体化重 建模式具有更高的稳定性，发生近、远期支架移植物移位造成冠脉开窗失去对位、迟发型内漏等的风险比组合式支架移植物更小。
进一步地，如图4所示，除了通过第一分支架102，还可以通过第二分支架103将所述升主动脉支架移植物限定在升主动脉合适的位置，例如，使得该升主动脉支架移植物能够牢固锚定于升主动脉，防止发生沿主动脉轴向的移位，或是发生来源于远心端的内漏。此外，在主动脉病变累及冠状动脉、升主动脉和主动脉弓近端中前二者或三者都累及的情况下，采用本实施方式的升主动脉支架移植物，可以通过一次微创介入实现完全腔内治愈，具有更高的稳定性，发生近、远期支架移植物移位造成冠脉开窗失去对位、迟发型内漏等的风险比组合式支架移植物更小，同时，朝向或进入主动脉弓的第二分支架103为进一步置入支架移植物重建主动脉弓远端和降主动脉提供了接头。
图5是根据本发明的另一种实施方式的具有鼓型近心端的升主动脉支架移植物的正视示意图，其标记了鼓型的高度H。图6是图5所示的具有鼓型近心端的升主动脉支架移植物的另一正视示意图，其标记了鼓型的突出量h。为了使附图清晰可见，图5、6中未分别画出支架丝和覆盖体。
根据图5和图6所述的实施方式的升主动脉支架移植物与根据图1-3所述的实施方式的升主动脉支架移植物的区别在于主支架101的靠近近心端的一段呈鼓型，以适配主动脉窦部的形状。具体而言，在所述升主动脉支架移植物径向扩展的状态下，所述鼓型的近心缘距离支架移植物近心端的距离0-50m，鼓型的高度H为10-30mm，并且，该鼓型沿所述支架的径向突出的最大突出量h为3-15mm，换言之，该鼓型最高点相对于基线(图6中的竖虚线)突出3-15mm。其中，H和h的具体值可以根据实际需要进行设置，例如根据特定患者的升主动脉的解剖结构进行设置。这样，可以在升主动脉支架移植物的近心端内提供主动脉瓣的足够活动空间，以避免主动脉瓣对冠状动脉的开窗的遮挡，也为再次腔内置入主动脉瓣时保留冠脉开口提供了空间。此外，这样的形状设计还有利于升主动脉支架移植物的近心端与主动脉根部贴合，提高支架移植物对主动脉窦内破裂口的隔绝效能，有利于升主动脉重建。
综上所述，如图4所示，根据实施方式的升主动脉支架移植物，覆人工血管膜的支架起隔绝主动脉病变(夹层破口或主动脉瘤)的作用，可为直筒型，也可为分叉型。所谓分叉型为远端带有两个分支，长腿(即第一分支架102)放置于头臂干动脉(即无名干动脉)里面，短腿(即第二分支架103)对着主动脉弓，便于后续进一步接支架移植物重建主动脉弓；支架近心端缝有生物主动脉瓣，用于重建主动脉瓣；在冠状动脉的相应部位进行人工血管膜的开窗，用于保留冠脉血供。
图7是根据本发明的另一种实施方式的升主动脉支架移植物的立体示意图。图8是图7所示的升主动脉支架移植物的切除位于主支架外部的第一分支架后的俯视示意图。图9是示出了图7的升主动脉支架移植物植入升主动脉血管内的情形的示意图。为了使附图清晰可见，图7-9中未分别画出支架丝和覆盖体。
本发明的该实施方式中，如图7和8所示，升主动脉支架移植物可以包括主支架201、第一分支架202和内支架203。尽管未示出，但本领域技术人员应当理解，所述升主动脉支架移植物还包括覆盖在这些支架上的人工血管膜。其中，如图7所示，所述第一分支架202的一部分和所述内支架203并排设置在所述主支架201内，并且，所述内支架203的远心端与所述主支架201的远心端齐平，即大致在一个平面内。可选地，所述内支架203的远心端超出所述主支架201的远心端。如图8所示，在所述主支架201的远心端，所述第一分支架202的外周、所述内支架203的外周与所述主支架201的内周之间的空隙通过密封体204封闭或密封，以使血液不能流过这三种支架之间的间隙。此外，在主支架201的近心端内设置有用于重建主动脉瓣的瓣叶700，在靠近所述主支架201的近心端可具有适于对准两个冠状动脉的开窗601、602。
如图9所示，根据本实施方式的升主动脉支架移植物，在微创介入手术中，第一分支架202适于进入无名干动脉800，通过在主支架201内套设分支架202、内支架203的结构，可以使主支架201更好地贴合血管壁，从而使得该升主动脉支架移植物的近心端能够准确锚定于主动脉瓣环，支架移植物上的冠脉开窗601、602能够准确对准冠脉901、902的开口，在准确重建主动脉瓣和冠状动脉的基础上隔绝夹层近端裂口或动脉瘤，使得夹层假腔或动脉瘤 体血栓化而萎缩，达到治愈目的。与图4所示的实施方式相比，由于在主支架201内套设分支架202、内支架203可以使主支架201更好地贴合血管壁，对累及升主动脉中间区域的病变，例如主动脉瘤，有更好的治疗效果。
以上虽然结合附图对本发明的各种不同实施方式进行了具体说明，但是为了使本发明的特征、优点等更加明显，下面结合图10对本发明实施方式的升主动脉支架移植物的动物实验结果进行说明。
前期发明人采用健康成年家猪(60-65千克)进行了动物实验。首先，发明人对家猪进行主动脉CT血管造影(CTA)检查，明确其主动脉根部解剖结构后，制作升主动脉支架移植物，其构型如下：近心端缝有牛心包制成的生物主动脉瓣；靠近心端有两个开窗，目的是保留左、右冠状动脉开口；远心端为分叉型，有一长腿(即第一分支架)，拟置于头臂干动脉内，由于猪的升主动脉段很短，只有不到2cm，所以，另一短腿(即第二分支架)仅保留一开口，对着主动脉弓部；支架移植物的主体为筒状结构。在实际实验中，在全麻下，小切口解剖猪心尖(图10中的图片A)，造影明确左右冠状动脉开口角度和位置后(图10中的图片B、C)，经心尖导入支架移植物，在确保轴向和周向定位能够良好保留冠状动脉后(图10中图片D)，释放支架移植物，然后，造影结合食道超声检查评估支架移植物的位置、主动脉瓣的功能、冠脉的通畅情况等(图10中图片E-J)。经动物实验随访期主动脉CTA证实(图10中图片K)，采用该升主动脉支架移植物，能够微创腔内重建主动脉根部(包括主动脉瓣)和升主动脉，保留左、右冠状动脉，同时为进一步重建主动脉弓部和降主动脉提供了接头。其适用于解决以下疾病：累及主动脉窦、冠状动脉开口、主动脉瓣的升主动脉夹层和主动脉瘤、主动脉瓣严重关闭不全或严重狭窄伴升主动脉瘤等。
图11是示出了根据本发明的另一种实施方式的具有喇叭状近心端的升主动脉支架移植物植入升主动脉血管及左室流出道内的情形的示意图。本实施方式与图1-4所示的实施方式的不同在于，在图1-4所示的支架移植物的近心端增加一段喇叭状结构。换句话说，在图11所示的升主动脉支架移植物中，当处于径向扩展的状态下，该支架移植物的近心端为喇叭状结构。所述喇叭状结构的近心端距离所述瓣叶的近心缘0-40mm，即伸入到左室流出道内，并 且，该喇叭状结构的近心端的口径为22-48mm。
可选地，在图5-6、图7-9所示的实施方式的基础上，也可以在所述支架移植物的近心端增加一段喇叭状结构。
所述喇叭状结构适于伸入心脏的左室流出道里面，可以实现锚定支架的有益效果。本领域技术人员应当理解，本发明不限于采用喇叭状结构，可以采用其近心端的口径稍大，然后逐渐缩小的任何形状的结构。
本领技术人员应当理解，以上所公开的仅为本发明的实施方式而已，当然不能以此来限定本发明之权利范围，依本发明实施方式所作的等同变化，仍属本发明权利要求所涵盖的范围。

Claims (25)

  1. 一种升主动脉支架移植物，其特征在于，包括：
    支架；
    至少部分覆盖所述支架的覆盖体；
    用于重建主动脉瓣的瓣叶，所述瓣叶设置在所述支架的近心端并且与所述覆盖体和支架连接。
  2. 如权利要求1所述的升主动脉支架移植物，其特征在于，所述支架包括适于植入至升主动脉的主支架和位于主支架的远心端的适于植入至分支动脉的第一分支架。
  3. 如权利要求2所述的升主动脉支架移植物，其特征在于，所述主支架的长度为35-155mm。
  4. 如权利要求2所述的升主动脉支架移植物，其特征在于，所述第一分支架的长度为45-105mm。
  5. 如权利要求2所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述主支架呈大致筒状且其近心端的直径为22-48mm，远心端的直径为30-50mm。
  6. 如权利要求5所述的升主动脉支架移植物，其特征在于，所述主支架的直径沿其轴向从其近心端至远心端先逐渐变大然后逐渐变小，其中，最大直径为28-50mm。
  7. 如权利要求2所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述第一分支架呈大致筒状且其近心端的直径为6-16mm，远心端的直径为10-26mm。
  8. 如权利要求7所述的升主动脉支架移植物，其特征在于，所述第一分支架的直径沿其轴向从其近心端至远心端逐渐变大。
  9. 如权利要求2所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述第一分支架的近心端的直径与所述主支架的远心端的直径之比为1:1-1:6。
  10. 如权利要求2所述的升主动脉支架移植物，其特征在于，所述支架还包括与所述第一分支架相邻且适于朝向或进入主动脉弓的第二分支架。
  11. 如权利要求10所述的升主动脉支架移植物，其特征在于，所述第二分支架的长度为40-80mm。
  12. 如权利要求10所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述第二分支架呈大致筒状且其近心端的直径为25-42mm，远心端的直径为25-50mm。
  13. 如权利要求12所述的升主动脉支架移植物，其特征在于，所述第二分支架的直径沿其轴向从其近心端至远心端逐渐变大。
  14. 如权利要求10所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述第二分支架的近心端的直径与所述主支架的远心端的直径之比为1:4-1:1。
  15. 如权利要求1所述的升主动脉支架移植物，其特征在于，所述瓣叶在所述支架的内部，缝合在所述支架和覆盖体上。
  16. 如权利要求1所述的升主动脉支架移植物，其特征在于，靠近所述支 架的近心端具有两个适于对准两个冠状动脉开口的开窗。
  17. 如权利要求16所述的升主动脉支架移植物，其特征在于，所述开窗的近心缘设置在距支架的近心端5-50mm处。
  18. 如权利要求16所述的升主动脉支架移植物，其特征在于，在所述开窗的水平方向上相对的边缘分别设有适于在植入所述升主动脉支架移植物的过程中用于对位的标记。
  19. 如权利要求18所述的升主动脉支架移植物，其特征在于，在所述主支架的中段部分和靠近远心端的部分中的至少一个中，在水平方向上相对的两侧分别设有适于在植入所述升主动脉支架移植物的过程中用于对位的标记。
  20. 如权利要求1所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述升主动脉支架移植物靠近近心端的一段呈鼓型。
  21. 如权利要求20所述的升主动脉支架移植物，其特征在于，所述鼓型的近心缘距离支架移植物近心端0-50mm
  22. 如权利要求20所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，所述鼓型的高度为10-30mm，并且，该鼓型沿所述支架的径向突出的最大突出量为3-15mm。
  23. 如权利要求2所述的升主动脉支架移植物，其特征在于，还包括内支架；
    所述第一分支架的一部分和所述内支架并排设置在所述主支架内，所述内支架的远心端与所述主支架的远心端大致在一个平面内，或所述内支架的远心端超出所述主支架的远心端；并且，在所述主支架的远心端，所述第一 分支架的外周、所述内支架的外周与所述主支架的内周之间的空隙通过密封体密封。
  24. 如权利要求1所述的升主动脉支架移植物，其特征在于，在所述升主动脉支架移植物径向扩展的状态下，该支架移植物的近心端外表面为喇叭状结构。
  25. 如权利要求24所述的升主动脉支架移植物，其特征在于，所述喇叭状结构的近心端距离所述瓣叶的近心缘为0-40mm，并且，该喇叭状结构的近心端的口径为22-48mm。
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