WO2021227612A1 - 一种覆膜支架 - Google Patents

一种覆膜支架 Download PDF

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Publication number
WO2021227612A1
WO2021227612A1 PCT/CN2021/078991 CN2021078991W WO2021227612A1 WO 2021227612 A1 WO2021227612 A1 WO 2021227612A1 CN 2021078991 W CN2021078991 W CN 2021078991W WO 2021227612 A1 WO2021227612 A1 WO 2021227612A1
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WO
WIPO (PCT)
Prior art keywords
stent
main
interface
sub
branch
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PCT/CN2021/078991
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English (en)
French (fr)
Inventor
朱清
朱永锋
袁振宇
赵明杰
张军利
Original Assignee
上海微创心脉医疗科技(集团)股份有限公司
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Application filed by 上海微创心脉医疗科技(集团)股份有限公司 filed Critical 上海微创心脉医疗科技(集团)股份有限公司
Priority to EP21803461.9A priority Critical patent/EP4129233A4/en
Publication of WO2021227612A1 publication Critical patent/WO2021227612A1/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
    • A61F2/04—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
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—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
    • A61F2/82—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
    • A61F2002/061—Blood vessels provided with means for allowing access to secondary lumens
    • 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
    • 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
    • A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve

Definitions

  • the invention belongs to the technical field of medical devices, and specifically relates to a covered stent.
  • aortic diseases such as aortic aneurysms are one of the most dangerous acute and severe cardiovascular diseases.
  • the treatment methods of aortic disease include drug therapy, surgical treatment, interventional therapy, etc.
  • the principle of interventional therapy is: the compressible stent is delivered to the diseased part in the blood vessel and then released. After the stent expands in the blood vessel, The diseased part is isolated from the vascular cavity, allowing blood to pass through the stent, thereby protecting the diseased blood vessel, and then achieving the purpose of repairing the diseased blood vessel. Interventional therapy is widely used because of its advantages such as small trauma, safety, and effectiveness.
  • a straight-tube stent can be used for interventional treatment.
  • a straight-tube stent is used to isolate the lesion and there will be branch vessels covering the aortic arch. The problem. Therefore, it is an urgent problem to develop a stent that conforms to the anatomical structure of the aortic arch and avoids covering the branch vessels of the aortic arch.
  • the purpose of the present invention is to provide a stent graft, which is adapted to the anatomical structure of the aortic arch, and is implanted into the aortic arch to avoid covering the branch blood vessels while isolating the diseased part.
  • the present invention provides a stent graft, which includes a main stent, a first interface, a second interface, and a first branch stent;
  • the main stent includes a first stent body and a first stent body covering the first stent body
  • the first covering film, the first branch stent includes a second stent body and a second covering film covering the second stent body;
  • the first interface is arranged on the side of the main stent, and is connected to the The inner cavity of the main stent is in communication;
  • the first branch stent is arranged on the first interface and extends outward, and the end of the second stent body close to the main stent is in contact with the second covering film
  • a recessed area is formed on the side surface of the main bracket;
  • the second interface is arranged on the recessed area and communicates with the inner cavity of the main bracket.
  • the first interface is provided on a side surface of the main bracket other than the recessed portion.
  • the depth of the recessed area is greater than or equal to 5 mm.
  • the first interface includes a first window and a first positioning ring; the first window is opened on the first covering film of the main stent; the first positioning ring is provided on the first window , And used to support the first window.
  • the stent graft further includes a third interface, the third interface is provided in the recessed area of the main stent and communicates with the inner cavity of the main stent; the first interface, the The second interface and the third interface are arranged at intervals along the axial direction of the main bracket.
  • the second interface includes a second window and a second positioning ring; the second window is opened on the first covering film of the main stent; the second positioning ring is provided on the second window , And used to support the second window.
  • the first support body includes a first sub-support body and at least two second sub-support bodies, and at least two second sub-support bodies are respectively arranged on an axis of the first sub-support body.
  • the first sub-support body and the second sub-support bodies on both sides enclose the recessed area; or,
  • the first stent body includes at least two adjacently arranged first sub-stent bodies and at least two second sub-stent bodies, and at least two second sub-stent bodies are respectively arranged on two adjacent first sub-stents.
  • the first sub-stent body and the second sub-stent bodies on both sides enclose the recessed area.
  • the minimum distance from any point on the second positioning ring to each of the first sub-stent bodies is greater than Or equal to 2mm.
  • the second interface further includes a joint bracket; the joint bracket is arranged at the second window and connected with the second positioning ring; the axis of the joint bracket is perpendicular to the main bracket Axis.
  • one end of the joint bracket is connected to the second positioning ring, and the other end extends into the recessed area or into the inner cavity of the main bracket.
  • the extension length of the joint bracket is 3 mm-10 mm.
  • the third interface includes a third window and an embedded stent; the third window is opened on the first covering film of the main stent; the embedded stent is arranged in the inner cavity of the main stent And extend along the axial direction of the main stent; one end of the embedded stent is connected with the third window, and the other end is connected with the inner cavity of the main stent.
  • the built-in stent includes a distal end and a proximal end, and the distal end of the built-in stent is connected to the third window along the direction from the distal end to the proximal end of the built-in stent.
  • the inner diameter of the embedded stent gradually decreases.
  • the angle between the axis of symmetry of the first sub-bracket body and the line connecting the center of the main bracket and the center of the third interface is 0°- 45°.
  • the main stent has a first side and a second side that are diametrically opposed, and the recessed area is arranged on the first side; each of the first sub-stent bodies includes a plurality of V that are connected end to end in sequence.
  • each of the second sub-stent bodies includes a plurality of V-shaped rods connected end to end in turn, and in the axial direction of the main stent, the length of the multiple V-shaped rods of the same second sub-stent body is along the length The direction from the second side to the first side gradually increases.
  • the main stent has a first side and a second side diametrically opposite to each other, and the recessed area is disposed on the first side; the main stent further includes a back rib extending along the axial direction of the main stent The back ribs are arranged on the two axial sides of the recessed area, and are connected with the second sub-stent body and/or the first covering film.
  • the main stent has opposite proximal and distal ends, and at least part of the second sub-stent body located at the proximal and/or distal ends of the main stent is not covered by the first membrane. Cladding.
  • the main stent has opposite proximal and distal ends, and at least a part of the second sub-stent body located at the proximal and/or distal ends of the main stent and the first covering film are Non-fixed connection.
  • the stent graft further includes a second branch stent and/or a third branch stent; the second branch stent is configured to be arranged at the second interface and detachably connected to the second interface;
  • the third branch bracket is used to be arranged at the third interface and detachably connected with the third interface.
  • the main stent has opposite proximal and distal ends, in a direction from the distal end to the proximal end of the main stent, the main stent includes a front arch, a back arch, and a back arch.
  • An interface and the recessed area are both provided on the bow section, wherein the axial length of the front bow section is 2 cm-10 cm, and/or the axial length of the rear bow section is 1 cm-20 cm.
  • the diameter of the posterior segment of the arch gradually decreases.
  • a developing element is provided at the first interface, the second interface, and the third interface, respectively.
  • the second stent body includes a plurality of third sub-stent bodies sequentially arranged along its axial direction, and at least a part of the third sub-stent body located at the distal end of the second stent body is not The second cover film is covered; or, at least part of the area of the third sub-stent body located at the distal end of the second stent body that is not covered by the second cover film is a non-fixed connection.
  • the stent graft of the present invention has the following advantages:
  • the first branch stent provided on the first interface is implanted into a branch blood vessel, so that blood flow can enter from the lumen of the first branch stent.
  • the recessed area covers the other two branch blood vessels, and the second interface and the third interface are arranged in the recessed area.
  • the second interface is provided with the joint bracket, and the second branch bracket is inserted into the joint bracket to communicate with the inner cavity of the main bracket.
  • the second branch stent is implanted in the second branch blood vessel so that blood flow can enter the second branch blood vessel from the lumen of the second branch stent.
  • the third interface is provided with the embedded stent, and the split-type third branch stent communicates with the inner cavity of the main stent by being inserted into the embedded stent.
  • the third branch stent is implanted in the third branch blood vessel so that blood flow can enter the third branch blood vessel from the lumen of the third branch stent.
  • the covered stent of the present invention can ensure the smooth blood circulation of the branch blood vessels, and at the same time avoid the internal leakage of the joint part of the main stent and the branch stent.
  • the positioning of the stent is simple, and the opening of the branch stent can be easily matched with the opening of the branch blood vessel.
  • Figure 1 is a schematic diagram of a partial structure of the human aorta
  • FIG. 2 is a schematic structural diagram of a stent graft according to an embodiment of the present invention. In the figure, neither the second interface nor the third interface is provided with a branch stent;
  • Fig. 3 is a partial schematic diagram of the main stent of the stent graft shown in Fig. 2;
  • Fig. 4 is a schematic diagram of the stent graft shown in Fig. 2 when the stent graft is implanted in the aorta;
  • FIG. 5 is a schematic structural diagram of a second sub-stent body of the stent graft according to an embodiment of the present invention.
  • Fig. 6a is a schematic structural diagram of a first sub-stent body of a stent graft according to an embodiment of the present invention
  • Fig. 6b is a schematic diagram of the connection of two first sub-stent bodies of the stent graft according to an embodiment of the present invention.
  • Fig. 7 is a schematic structural diagram of a first positioning ring of a stent graft according to an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of the distal end of the first branch stent of the stent graft according to an embodiment of the present invention.
  • FIG. 9 is a schematic diagram of the stent graft provided by one embodiment of the present invention when implanted in the aorta.
  • the second interface is provided with a second branch stent and the third interface is provided with a third branch stent;
  • Figure 10a is a partial schematic view of the main stent of the stent graft according to an embodiment of the present invention.
  • the joining stent is arranged in the inner cavity of the main stent;
  • Figure 10b is a partial schematic view of the main stent of the stent graft according to an embodiment of the present invention, in which the joining stent is arranged in the recessed area in the figure;
  • FIG. 11 is a schematic diagram of a radial cross-section of the main stent of the stent graft according to an embodiment of the present invention.
  • FIG. 12 is a schematic diagram of the distal end of the main stent of the stent graft according to an embodiment of the present invention.
  • Fig. 13 is a schematic diagram of the proximal end of the main stent of the stent graft according to an embodiment of the present invention.
  • the singular forms “a”, “an” and “the” include plural objects, and the plural form “plurality” includes two or more objects, unless the content clearly indicates otherwise.
  • the term “or” is usually used to include the meaning of “and/or”, unless the content clearly indicates otherwise, and the terms “installed”, “connected”, and “connected” shall be used. In a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection. It can be a mechanical connection or an electrical connection. It can be directly connected, or indirectly connected through an intermediate medium, and it can be a communication between two elements or an interaction relationship between two elements.
  • the specific meanings of the above-mentioned terms in the present invention can be understood according to specific situations.
  • the same or similar reference signs in the drawings represent the same or similar components.
  • proximal and distal refer to the relative position and relative direction of elements relative to each other from the perspective of the doctor using the medical device, although “proximal” and “distal” are not restrictive Yes, but the “distal” usually refers to the end of the medical device that first enters the patient's body during normal operation, and the “proximal” usually refers to the end close to the doctor.
  • Fig. 1 shows a schematic diagram of the partial structure of the human aorta, and mainly shows the aortic arch 11 with the upper part of the aorta curved in an arcuate shape. Taking the orientation shown in FIG. 1 as an example, the part of the aorta adjacent to the left side of the aortic arch 11 is the ascending aorta 12, and the part of the aorta adjacent to the right side of the aortic arch 11 is the descending aorta 13.
  • aortic arch 11 There are three branched blood vessels on the convex side of the aortic arch 11, from left to right, the innominate artery 14 (ie, the brachiocephalic artery), the left common carotid artery 15 and the left subclavian artery 16 in order.
  • the innominate artery 14 ie, the brachiocephalic artery
  • the left common carotid artery 15 ie, the brachiocephalic artery
  • left subclavian artery 16 there are three branched blood vessels on the convex side of the aortic arch 11, from left to right, the innominate artery 14 (ie, the brachiocephalic artery), the left common carotid artery 15 and the left subclavian artery 16 in order.
  • the medical stent needs to be implanted in the aortic arch 11 for treatment, and the medical stent should not block the three branch blood vessels.
  • an embodiment of the present invention provides a stent graft.
  • the stent graft includes a main stent 100, a first interface, a second interface, and a first branch stent 310;
  • the main stent 100 includes A first stent body and a first covering film 120 covering the first stent body.
  • the first branch stent 310 includes a second stent body and a second covering film 312 covering the second stent body.
  • the first interface is arranged on the side of the main support 100 and communicates with the inner cavity of the main support 100; the first branch support 310 is arranged on the first interface and extends outward, and An end of the second stent body close to the main stent 100 is at least partially connected to the second covering film 312 in the circumferential direction.
  • a recessed area 101 is formed on the side of the main support 100; the second interface is disposed on the recessed area 101 of the main support 100 and communicates with the inner cavity of the main support 100.
  • the side of the main stent 100 formed with the recessed area 101 is called the first side, and the other side diametrically opposite to it is called the second side.
  • the first side is arranged toward the greater curvature side of the aortic arch 11 to provide support to the vessel wall on the greater curvature side of the aortic arch 11, and the second side faces the aortic arch 11
  • the minor curvature side of the aortic arch 11 is arranged to provide support for the vessel wall on the minor curvature side of the aortic arch 11.
  • the first branch stent 310 is implanted in a branch vessel such as the innominate artery 14 to improve the anchoring stability of the stent graft in the aorta and avoid displacement.
  • the main stent 100 and the first branch stent 310 are integrally connected.
  • the main stent 100 includes a first stent body and a first covering film 120 covering the first stent body
  • the first branch stent 310 includes a second stent body and a second stent covering the second stent body. Cladding 312.
  • one end of the second stent body close to the main stent 100 is fully connected to the second covering film 312 in the circumferential direction, so that the first branch stent 310 is fixedly connected. Set at the first interface.
  • one end of the second stent body close to the main stent 100 is partially connected to the second covering film 312 in the circumferential direction, so that the first branch stent 310 It can be movably arranged at the first interface.
  • the first covering film 120 and the second covering film 312 may be integrally formed, or the first covering film 120 and the second covering film 312 may be separately formed, and then stitched, hot pressed Or connect them in other suitable ways.
  • a recessed area 101 is formed on the side of the main support 100, and the second interface is disposed on the recessed area 101 of the main support 100 and communicates with the inner cavity of the main support 100.
  • the recessed area 101 may cover one or two branch blood vessels.
  • the second interface is used to insert a split second branch bracket 320, and the second branch bracket 320 communicates with the inner cavity of the main bracket 100.
  • the second branch stent 320 is implanted in a branch blood vessel, such as the left common carotid artery 15, so that blood flow enters the left from the lumen of the second branch stent 320 In the common carotid artery 15 to ensure smooth blood flow in the left common carotid artery 15.
  • the depth of the recessed area 101 is greater than or equal to 5 mm, and the depth of the recessed area 101 refers to the size of the recessed area 101 in the radial direction of the main stent 100.
  • the main stent 100 is divided into a front segment S1, a segment S2, and a back segment S3. Both the interface and the recessed area 101 are arranged on the bow section S2.
  • the anterior arch segment S1 is placed in the ascending aorta 12
  • the arch segment S2 is placed in the aortic arch 11
  • the posterior arch segment S3 is placed in the descending aorta.
  • the diameter of the posterior arch segment S3 gradually decreases from the distal end to the proximal end of the main stent 100 to adapt to the change in the diameter of the descending aorta 13.
  • the positioning stability of the stent graft in the aorta can be improved.
  • the axial length of the anterior bow segment S1 is 2 cm-10 cm
  • the axial length of the posterior bow segment S3 is 1 cm-20 cm.
  • a third interface is further provided on the main support 100, and the third interface is provided in the recessed area 101 and is connected to the The inner cavity of the main bracket 100 is connected.
  • the first interface, the second interface, and the third interface are sequentially spaced apart along the axial direction of the main bracket 100.
  • the second interface is used to detachably set a split second branch bracket 320
  • the third interface is used to detachably set a split third branch bracket 330.
  • the first interface may be disposed in an area other than the recessed area 101.
  • the first interface is set close to the distal end of the main stent 100, so that the The first branch stent 310 can be implanted into the innominate artery 14, and the recessed area 101 covers the left common carotid artery 15 and the left subclavian artery 16.
  • the first interface When the lesion occurs between the left common carotid artery 15 and the left subclavian artery 16, the first interface is set close to the proximal end of the main stent 100, so that the first interface on the first interface is set
  • the branch stent 310 can be implanted into the left subclavian artery 16, and the depressed area 101 covers the innominate artery 14 and the left common carotid artery 15.
  • the first interface may also be provided in the recessed area 101, and the stent graft may be applied to the situation where the lesion occurs on the lesser curvature side of the aortic arch.
  • the first interface is provided on the side of the main stent other than the recessed area 101, and the first branch stent 310 is used to implant the innominate artery 14 as an example.
  • the skilled person can modify the following description to adapt it to the situation when the first branch stent 310 is implanted in the left subclavian artery 16 or the situation when the first interface is arranged in the recessed area 101.
  • the first bracket body of the main bracket 100 includes a first sub bracket body 111 and at least two second sub bracket bodies 112.
  • the number of the first sub-stent body 111 is one, at least two of the second sub-stent bodies 112 are respectively disposed on both axial sides of one first sub-stent body 111, and The first sub-support body 111 and the second sub-support bodies 112 on both sides form the recessed area.
  • the number of the first sub-support 111 is at least two, and at least two of the first sub-support 111 are arranged adjacently and can be connected by a metal rod.
  • the material of the metal rod may be the same as the material of the first sub-stent body 111; at least two second sub-stent bodies 112 are arranged on both sides of the axial direction of at least two adjacent first sub-stent bodies 111.
  • the radial cross section of the first sub-stent body 111 may be C-shaped, and all the openings of the first sub-stent body 111 are arranged on the first side.
  • the cross-section of the first sub-support 111 may be D-shaped, and at this time, the number of the first sub-support 111 is at least two.
  • the cross section of the second sub-support body 112 may be circular or elliptical. In this way, when the first covering film 120 covers the outer surfaces of the first sub-stent body 111 and the second sub-stent body 112, the first side of the main stent 100 forms the Recessed area 101.
  • each of the second sub-support bodies 112 includes a plurality of V-shaped rods connected end to end in sequence. As shown in Fig. 5 a), in the axial direction of the main stent 100, the lengths of the multiple V-shaped rods of the same second sub-stent body 112 may be equal.
  • the lengths of at least part of the V-shaped rods in the same second sub-stent body 112 may also be unequal, and preferably the V
  • the length of the shaped rod gradually increases in the direction from the second side of the main bracket 100 to the first side, so that the rigidity of the second sub-bracket body 112 can be increased from the second side to the first side.
  • the direction of the first side gradually increases, so that the second side is easier to bend and adapt to the less curved side of the aortic arch.
  • the rigidity of the second sub-support body 112 may gradually increase in the direction from the second side to the first side by other means.
  • the first sub-support body 111 can also be arranged in a manner similar to the second sub-support body 112.
  • the main support 100 further includes a back rib 130 extending along the axial direction of the main support, and the back rib 130 is disposed on the first side of the main support 100.
  • the main stent 100 may include at least two sections of back ribs 130, and the two sections of the back ribs 130 are respectively arranged on both axial sides of the recessed area 101 to reduce the shortening rate of the main stent 100.
  • the back ribs 130 may be disposed on the second sub-support body 112, and each back rib 130 connects at least two second sub-support bodies 112.
  • the back rib 130 may also be connected to the first covering film 120.
  • the first interface is disposed outside the recessed area 101 and close to the distal end of the recessed area 101.
  • the first interface includes a first window and a first positioning ring 211.
  • the first window is opened on the first covering film 120, the first positioning ring 211 may be formed by bending an elastic metal wire, and the first positioning ring 211 is provided at the first window and is connected to the The first covering film 120 is connected.
  • the first positioning ring 211 is used to support the first window so as to open the first window, and ensure that blood can flow into the first branch stent 310 from the first window, and then into the innominate artery 14.
  • a visualization element 212 is provided on the first interface, so as to determine the position of the first interface during the operation, so that the first branch stent 310 can be accurately implanted into the innominate artery 14.
  • the developing element 212 may be a developing strip or a developing wire.
  • the developing element 212 is disposed on the first covering film 120 and arranged around the first window.
  • the developing element 212 is wound on the first positioning ring 211, as shown in FIG. 7.
  • the second stent body of the first branch stent 310 may include a plurality of third sub-stent bodies 311 sequentially arranged along its axial direction. At least one of the third sub-stent bodies 311 located at the proximal end of the first branch stent 310 is covered by the second covering film 312 and inserted into the first window to interact with the first covering film 120 And the first positioning ring 211 are connected so that the axis of the first branch bracket 310 is perpendicular to the axis of the main bracket 100. In some embodiments, as shown in a) of FIG.
  • the third sub-stent body 311 located at the distal end of the second stent body may be completely covered by the second covering film 312. In some embodiments, at least a part of the third sub-stent body 311 located at the distal end of the second stent body is not covered by the second covering film 312, as shown in b) of FIG. 8, At least a part of the third sub-stent body 311 located at the distal end of the second stent body is not covered by the second covering film 312. In some embodiments, as shown in FIG.
  • At least two of the third sub-stent bodies 311 at the distal end of the second stent body are not covered by the second covering film 312, at this time
  • the distal end of the second stent body can straddle the bifurcation of the innominate artery 14 to further enhance the anchoring stability of the stent graft without blocking the blood flow at the bifurcation of the innominate artery 14.
  • at least a part of the third sub-stent body 311 located at the distal end of the second stent body that is not covered by the second covering film 312 is a non-fixed connection.
  • the second interface is provided at the opening of the first sub-support body 111 and includes a second window and a second positioning ring 221.
  • the second window is opened on the first covering film 120
  • the second positioning ring 221 is arranged at the second window and connected with the first covering film 120.
  • the second positioning ring 221 is used to support the second window to open the second window so that blood flow can flow out from the second port smoothly.
  • the first sub-support body 111 is movable to adjust the position of the second interface. Specifically, in this embodiment, the minimum distance from any point on the second positioning ring 221 to each of the first sub-support bodies is greater than or equal to 2 mm.
  • the second interface is arranged at Between two adjacent first sub-support bodies 111, and the distance from any point on the second positioning ring 221 to each of the first sub-support bodies 111 is greater than or equal to 2 mm.
  • the position of the second interface can be adjusted relative to the first sub-support body 111, when the second branch support 320 is provided on the second interface, even if the second interface is not connected to the left neck
  • the common artery 15 is aligned, but by adjusting the position of the second interface, the second branch stent 320 can be implanted into the left common carotid artery 15 when the first branch stent 310 is implanted in the innominate artery 14.
  • the position of the third interface can also be adjusted so that the three branch stents are respectively implanted in the corresponding branch blood vessels, as shown in FIG. 9 Show.
  • the second interface further includes a joint bracket 222.
  • the joint bracket 222 is arranged at the second window and is connected to the first covering film 120 and the second positioning ring 221 at the same time, and the axis of the joint bracket 222 is perpendicular to the axis of the main bracket 100 .
  • the purpose of this arrangement is that the main bracket 100 is connected to the second branch bracket 320 through the joint bracket 222 to increase the joint area between the second branch bracket 320 and the second interface and reduce internal leakage.
  • the extension length of the joint bracket 222 is between 3 mm and 10 mm.
  • one end of the joining bracket 222 is disposed at the second window and connected to the first covering film 120 and the second positioning ring 221, and the other end extends to The inner cavity of the main bracket 100 serves as a built-in joint bracket.
  • one end of the joining bracket 222 is disposed at the second window and connected to the first covering film 120 and the second positioning ring 221, and the other end extends to the recessed area 101 In order to become a joint bracket for peripherals.
  • the third interface includes a third window 231 and an embedded bracket 232.
  • the third window 231 is opened on the first covering film 120 of the main stent, and the embedded stent 232 is disposed in the inner cavity of the main stent 100 and extends along the axial direction of the main stent 100, Moreover, one end of the embedded bracket 232 is connected with the third window 231, and the other end is connected with the inner cavity of the main bracket 100.
  • the embedded stent 232 includes a distal end and a proximal end. The distal end of the embedded stent 232 is connected to the third window 231, and the inner stent 232 has a distal end to a proximal end. The inner diameter of the embedded bracket 232 gradually decreases.
  • the third branch stent 330 when the third branch stent 330 is provided on the third interface, in order to ensure that the third branch stent 330 can be smoothly implanted in the left subclavian artery 16, for different specifications of the covered membrane
  • the symmetry axis of the first sub-stent body is related to the center of the main stent and the third The range of the angle ⁇ between the line of the center of the interface is 0°-45°, as shown in Figure 11.
  • both the second interface and the third interface are provided with a visualization element, so that the branch stents provided on the second interface and the third interface can be implanted into the corresponding branch arteries.
  • the developing element on the second interface can be set with reference to the first interface.
  • the developing element can be provided on the third window of the third interface and the embedded bracket 232 respectively.
  • the main bracket 100, the joint bracket 222, and the embedded bracket 232 may be separately molded and then connected by suture or any other suitable method.
  • the main bracket 100, the joint bracket 222, and the embedded bracket 232 may have a separate structure.
  • the main bracket 100, the joint bracket 222, and the embedded bracket 232 may also be an integral structure. All covering films can be made of bio-non-degradable polymers such as expandable polytetrafluoroethylene (PTFE), polyester (PET), polyester (polyestPE, polyurethane (PU), real silk, etc.).
  • the stent graft provided by the embodiment of the present invention is delivered into the aorta of the patient through a delivery device.
  • the stent graft further includes a binding wire 400 for restraining the main stent 100 and the branch stents (ie, the first branch stent 310 and the second branch stent 320 after compression). And the third branch bracket 330).
  • the second sub-stent body 112 located at the proximal end or the distal end of the main stent 100 is not covered by the first covering film 120. Specifically, referring to FIG.
  • the apex of the same second sub-stent body 112 facing the distal end of the main stent 100 is called the distal apex
  • the apex facing the proximal end of the main stent 100 is called It is the proximal vertex.
  • FIG. 12 mainly.
  • at least part of the distal apex of a second sub-stent body 112 located at the distal end of the main stent 100 is not covered by the first covering film 120.
  • at least part of the proximal apex of a second sub-stent body 112 located at the proximal end of the main stent 100 is not covered by the first covering film 120.
  • the stent graft can be compressed and installed on the delivery device.
  • at least a part of the second sub-stent body 112 located at the distal end of the main stent 100 is non-fixedly connected to the first covering film 120, and is located at the proximal end of the main stent 100 At least a part of the second sub-stent body is non-fixedly connected to the first covering film 120.

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Abstract

一种覆膜支架，用于病变累及主动脉弓(11)的主动脉血管病变。覆膜支架包括主支架(100)、第一接口、第二接口和第一分支支架(310)；主支架(100)包括第一支架体和包覆第一支架体的第一覆膜(120)，第一分支支架(310)包括第二支架体和包覆第二支架体的第二覆膜(312)；第一接口设置在主支架(100)的侧面上，并与主支架(100)的内腔连通；第一分支支架(310)设置在第一接口上并向外延伸，且第二支架体的靠近主支架(100)的一端与第二覆膜(312)在周向上至少部分连接；主支架(100)的侧面上形成有凹陷区(101)；第二接口设置在凹陷区(101)上，并与主支架(100)的内腔连通。覆膜支架可广泛地应用于各类人群，无需针对个体进行定制，具有良好的治疗效果。

Description

一种覆膜支架 技术领域
本发明属于医疗器械技术领域，具体涉及一种覆膜支架。
背景技术
心血管疾病对人类的健康造成极大的威胁，特别是主动脉病变例如主动脉瘤是最为凶险的急、重症心血管疾病之一。目前，主动脉病变的治疗方法包括药物治疗、外科手术治疗、介入治疗等，其中，介入治疗的原理是：将可压缩的支架输送至血管内的病变部位后释放，支架在血管内扩张后，将病变部位隔绝于血管腔之外，使血液从支架内通过，从而保护病变的血管，进而达到修复病变血管的目的。介入治疗因其创伤小、安全、有效等优点而得到广泛应用。
对于病变不累及主动脉弓的主动脉瘤或主动脉夹层可采用直管型的支架进行介入治疗，而对于病变累及主动脉弓的病变，单纯采用直管型的支架隔绝病变就会存在覆盖主动脉弓上的分支血管的问题。因而开发符合主动脉弓解剖学结构并避免覆盖主动脉弓上分支血管的支架是一个亟待解决的问题。
发明内容
本发明的目的在于提供一种覆膜支架，该覆膜支架适应于主动脉弓的解剖学结构，将其植入主动脉弓，在隔绝病变部位的同时避免覆盖分支血管。
为实现上述目的，本发明提供的一种覆膜支架，包括主支架、第一接口、第二接口和第一分支支架；所述主支架包括第一支架体和包覆所述第一支架体的第一覆膜，所述第一分支支架包括第二支架体和包覆所述第二支架体的第二覆膜；所述第一接口设置在所述主支架的侧面上，并与所述主支架的内腔连通；所述第一分支支架设置在所述第一接口上并向外延伸，且所述第二支架体的靠近所述主支架的一端与所述第二覆膜在周向上至少部分地连接；所述主支架的侧面上形成有凹陷区；所述第二接口设置在所述凹陷区上，并与所述主支架的内腔连通。
可选地，所述第一接口设置在所述主支架的所述凹陷部以外的侧面上。
可选地，在所述主支架的径向上，所述凹陷区的深度大于或等于5mm。
可选地，所述第一接口包括第一窗口和第一定位环；所述第一窗口开设在所述主支架的第一覆膜上；所述第一定位环设置在所述第一窗口处，并用于支撑所述第一窗口。
可选地，所述覆膜支架还包括第三接口，所述第三接口设置在所述主支架的所述凹陷区，并与所述主支架的内腔连通；所述第一接口、所述第二接口及所述第三接口沿所述主支架的轴向间隔地布置。
可选地，所述第二接口包括第二窗口和第二定位环；所述第二窗口开设在所述主支架的第一覆膜上；所述第二定位环设置在所述第二窗口处，并用于支撑所述第二窗口。
可选地，所述第一支架体包括一个第一子支架体和至少两个第二子支架体，至少两个所述第二子支架体分别设置在一个所述第一子支架体的轴向两侧，所述第一子支架体与两侧的所述第二子支架体围成了所述凹陷区；或，
所述第一支架体包括至少两个相邻设置的第一子支架体和至少两个第二子支架体，至少两个所述第二子支架体分别设置在相邻的两个所述第一子支架体的轴向两侧，所述第一子支架体和两侧的所述第二子支架体围成所述凹陷区。
可选地，所述第二定位环与任一个所述第一子支架体之间具有间隙；且所述第二定位环上的任一点到每个所述第一子支架体的最小距离大于或等于2mm。
可选地，所述第二接口还包括接合支架；所述接合支架设置在所述第二窗口处，并与所述第二定位环连接；所述接合支架的轴线垂直于所述主支架的轴线。
可选地，所述接合支架的一端与所述第二定位环连接，另一端延伸至所述凹陷区内或延伸至所述主支架的内腔中。
可选地，在所述接合支架的轴向上，所述接合支架的延伸长度为3mm-10mm。
可选地，所述第三接口包括第三窗口和内嵌支架；所述第三窗口开设在所述主支架的第一覆膜上；所述内嵌支架设置在所述主支架的内腔中并沿所述主支架的轴向延伸；所述内嵌支架的一端与所述第三窗口连接，另一端与所述主支架的内腔连通。
可选地，所述内嵌支架包括远端和近端，所述内嵌支架的远端与所述第三窗口连接，沿所述内嵌支架的远端到近端的方向，所述内嵌支架的内径逐渐减小。
可选地，在所述主支架的横截面上，所述第一子支架体的对称轴与所述主支架的圆心和所述第三接口的圆心的连线的夹角范围为0°-45°。
可选地，所述主支架具有径向相对的第一侧和第二侧，所述凹陷区设置在所述第一侧；每个所述第一子支架体包括多个依次首尾相连的V形杆，在所述主支架的轴向上，同一个所述第一子支架体的多个V形杆的长度沿所述第二侧到所述第一侧的方向逐渐增大；和/或，每个所述第二子支架体包括多个依次首尾相连的V形杆，在所述主支架的轴向上，同一个所述第二子支架体的多个V形杆的长度沿所述第二侧到所述第一侧的方向逐渐增大。
可选地，所述主支架具有径向相对的第一侧和第二侧，所述凹陷区设置在所述第一侧；所述主支架还包括沿所述主支架的轴向延伸的背筋，所述背筋设置在凹陷区的轴向两侧，并与所述第二子支架体和/或所述第一覆膜连接。
可选地，所述主支架具有相对的近端和远端，位于所述主支架的近端和/或远端的所述第二子支架体的至少部分区域未被所述第一覆膜包覆。
可选地，所述主支架具有相对的近端和远端，位于所述主支架的近端和/或远端的所述第二子支架体的至少部分区域与所述第一覆膜为非固定连接。
可选地，所述覆膜支架还包括第二分支支架和/或第三分支支架；所述第二分支支架用于设置在所述第二接口处并与所述第二接口可拆卸连接；所述第三分支支架用于设置在所述第三接口处并与所述第三接口可拆卸连接。
可选地，所述主支架具有相对的近端和远端，沿所述主支架的远端到近端的方向，所述主支架包括弓前段、弓部段和弓后段，所述第一接口和所述凹陷区皆设置在所述弓部段上，其中，所述弓前段的轴向长度为2cm-10cm， 和/或，所述弓后段的轴向长度为1cm-20cm。
可选地，沿所述主支架的远端到近端的方向，所述弓后段的直径逐渐减小。
可选地，所述第一接口、所述第二接口及所述第三接口处分别设置有显影元件。
可选地，所述第二支架体包括多个沿其轴向依次布置的第三子支架体，位于所述第二支架体的远端的所述第三子支架体的至少部分区域未被所述第二覆膜包覆；或者，位于所述第二支架体的远端的所述第三子支架体的至少部分未被所述第二覆膜包覆的区域为非固定连接。
与现有技术相比，本发明的覆膜支架具有如下优点：
将所述覆膜支架植入患者的主动脉弓时，所述第一接口上设置的所述第一分支支架植入一个分支血管，从而血流可从所述第一分支支架的内腔进入与之匹配的分支血管中。所述凹陷区覆盖另外两个分支血管，所述凹陷区内设置有所述第二接口和所述第三接口。所述第二接口处设置有所述接合支架，所述第二分支支架通过插入所述接合支架与所述主支架的内腔连通。所述第二分支支架植入第二个分支血管中，使血流可从所述第二分支支架的内腔进入第二个分支血管中。所述第三接口处设置有所述内嵌支架，分体式的所述第三分支支架通过插入所述内嵌支架与所述主支架的内腔连通。所述第三分支支架植入第三个分支血管中，使血流可从所述第三分支支架的内腔进入第三个分支血管中。本发明的覆膜支架可以保证分支血管的血流通畅，同时避免主体支架和分支支架结合部发生内漏。并且支架的定位简便，分支支架的开口能够方便地与分支血管的开口匹配。
附图说明
图1是人体主动脉的局部结构示意图；
图2是本发明根据一实施例所提供的覆膜支架的结构示意图，图示中第二接口和第三接口上皆未设置分支支架；
图3是图2所示的覆膜支架的主支架的局部示意图；
图4是将图2所示的覆膜支架植入主动脉时的示意图；
图5是本发明根据一实施例所提供的覆膜支架的第二子支架体的结构示意图；
图6a是本发明根据一实施例所提供的覆膜支架的第一子支架体的结构示意图；
图6b是本发明根据一实施例所提供的覆膜支架的两个第一子支架体的连接示意图；
图7是本发明根据一实施例所提供的覆膜支架的第一定位环的结构示意图；
图8是本发明根据一实施例所提供的覆膜支架的第一分支支架的远端示意图；
图9是本发明根据一实施例所提供的覆膜支架植入主动脉时的示意图，图示中第二接口上设有第二分支支架及第三接口上设置有第三分支支架；
图10a是本发明根据一实施例所提供的覆膜支架之主支架的局部示意图，图示中接合支架设置在主支架的内腔中；
图10b是本发明根据一实施例所提供的覆膜支架之主支架的局部示意图，图示中接合支架设置在凹陷区中；
图11是本发明根据一实施例所提供的覆膜支架之主支架的径向截面示意图；
图12是本发明根据一实施例所提供的覆膜支架之主支架的远端的示意图；
图13是本发明根据一实施例中所提供的覆膜支架之主支架的近端的示意图。
[附图标记说明如下]：
100-主支架；
101-凹陷区；
111-第一子支架体，112-第二子支架体；
120-第一覆膜；
130-背筋；
211-第一定位环，212-显影元件；
221-第二定位环，222-接合支架；
231-第三窗口，232-内嵌支架；
310-第一分支支架，320-第二分支支架，330-第三分支支架；
311-第三子支架体，312-第二覆膜；
400-束缚线；
11-主动脉弓，12-升主动脉，13-降主动脉，14-无名动脉，15-左颈总动脉，16-左锁骨下动脉；
S1-弓前段，S2-弓部段，S3-弓后段。
具体实施方式
为使本发明的目的、优点和特征更加清楚，以下结合附图对本发明作进一步详细说明。需说明的是，附图均采用非常简化的形式且均使用非精准的比例，仅用以方便、明晰地辅助说明本发明实施例的目的。
如在本说明书中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，复数形式“多个”包括两个以上的对象，除非内容另外明确指出外。如在本说明书中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外，以及术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接。可以是机械连接，也可以是电连接。可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通或两个元件的相互作用关系。对于本领域的普通技术人员而言，可以根据具体情况理解上述术语在本发明中的具体含义。附图中相同或相似的附图标记代表相同或相似的部件。
本文中，术语“近端”、“远端”是从使用医疗器械的医生的角度来看相对于彼此的元件的相对位置、相对方向，尽管“近端”、“远端”并非是限制性的，但是“远端”通常是指该医疗器械在正常操作过程中首先进入患者体内的一端，而“近端”通常是指靠近医生的一端。
图1示出了人体主动脉的局部结构示意图，并主要显示了主动脉上部呈弓形弯曲的主动脉弓11。以图1所示方位为例，与主动脉弓11的左侧相邻的部分主动脉为升主动脉12，与主动脉弓11的右侧相邻的部分主动脉为降主动脉13。主动脉弓11的凸侧有三条分支血管，从左往右依次为无名动脉14(即头臂干动脉)、左颈总动脉15和左锁骨下动脉16。当主动脉弓11处发生病变后需要在主动脉弓11内植入医用支架以进行治疗，所述医用支架不应遮挡三条分支血管。
如图2及图3所示，本发明实施例提供一种覆膜支架，所述覆膜支架包括主支架100、第一接口、第二接口和第一分支支架310；所述主支架100包括第一支架体和包覆所述第一支架体的第一覆膜120，所述第一分支支架310包括第二支架体和包覆所述第二支架体的第二覆膜312。所述第一接口设置在所述主支架100的侧面上，并与所述主支架100的内腔连通；所述第一分支支架310设置在所述第一接口上并向外延伸，且所述第二支架体的靠近所述主支架100的一端与所述第二覆膜312在周向上至少部分地连接。所述主支架100的侧面上形成有凹陷区101；所述第二接口设置在所述主支架100的所述凹陷区101上，并与所述主支架100的内腔连通。
请参考图4，本发明实施例中将所述主支架100形成有所述凹陷区101的一侧称之为第一侧，与之径向相对的另一侧称之为第二侧，将所述覆膜支架植入主动脉时，所述第一侧朝向主动脉弓11的大弯侧布置，以对所述主动脉弓11的大弯侧的血管壁提供支撑力，所述第二侧朝向主动脉弓11的小弯侧布置，以对所述主动脉弓11的小弯侧的血管壁提供支撑力。将所述覆膜支架植入主动脉弓11时，所述第一分支支架310植入一个分支血管例如无名动脉14中，以提高所述覆膜支架在主动脉内的锚固稳定性，避免移位。
本发明实施例中，所述主支架100与所述第一分支支架310为一体化连接，将所述覆膜支架植入主动脉弓11时，血流从所述第一分支支架310的内腔进入与之匹配的无名动脉14中，在保证分支血管通畅的同时避免内漏。所述主支架100包括第一支架体和包覆所述第一支架体的第一覆膜120，所述第一分支支架310包括第二支架体和包覆所述第二支架体的第二覆膜312。在一 种可选的实现方式中，所述第二支架体的靠近所述主支架100的一端与所述第二覆膜312在周向上全部连接，以使所述第一分支支架310固定地设置在所述第一接口处。在另一种可选的实现方式中，所述第二支架体的靠近所述主支架100的一端与所述第二覆膜312在周向上部分地连接，以使所述第一分支支架310可活动地设置在所述第一接口处。此外，应知晓，所述第一覆膜120可与所述第二覆膜312一体成型，或者所述第一覆膜120与所述第二覆膜312分别成形后，再通过缝合、热压或其他合适的方式连接为一体。
所述主支架100的侧面上形成有凹陷区101，所述第二接口设置在所述主支架100的所述凹陷区101上，并与所述主支架100的内腔连通。将所述覆膜支架植入主动脉弓11时，所述凹陷区101可以覆盖一个或两个分支血管。所述第二接口用于插入一个分体式的第二分支支架320，所述第二分支支架320与所述主支架100的内腔连通。将所述覆膜支架植入主动脉弓11时，所述第二分支支架320植入一个分支血管中，例如左颈总动脉15，以使血流从所述第二分支支架320的内腔进入左颈总动脉15中，以保证左颈总动脉15的血流通畅。进一步地，所述凹陷区101的深度大于或等于5mm，所述凹陷区101的深度是指所述凹陷区101在所述主支架100之径向上的尺寸。
进一步地，请继续参考图2，从所述主支架100的远端到近端的方向，所述主支架100被划分为弓前段S1、弓部段S2及弓后段S3，所述第一接口和所述凹陷区101皆设置于所述弓部段S2上。在将所述覆膜支架植入患者的主动脉时，所述弓前段S1被设置于升主动脉12中，所述弓部段S2设置于主动脉弓11中，所述弓后段S3设置于降主动脉13中，且所述弓后段S3的直径沿所述主支架100的远端到近端的方向逐渐减小，以适应所述降主动脉13的直径变化。通过所述弓前段S1和所述弓后段S3的设置，可提高所述覆膜支架在主动脉内的定位稳定性。可选地，所述弓前段S1的轴向长度为2cm-10cm，所述弓后段S3的轴向长度为1cm-20cm。
进一步地，如图2及图3所示，在本发明的一些实施例中，所述主支架100上还设置有第三接口，所述第三接口设置在所述凹陷区101，并与所述主支架100的内腔连通。所述第一接口、所述第二接口及所述第三接口沿所述 主支架100的轴向依次间隔地布置。如图9所示，所述第二接口用于拆卸地设置分体式的第二分支支架320，以及所述第三接口用于可拆卸地设置分体式的第三分支支架330。
本发明的一些实施例中，所述第一接口可设置在所述凹陷区101以外的区域。当主动脉弓11处发生病变，且病变位于无名动脉14和左颈总动脉15之间时，所述第一接口靠近所述主支架100的远端设置，以使设置在所述第一接口上的所述第一分支支架310可植入无名动脉14，且所述凹陷区101覆盖左颈总动脉15和左锁骨下动脉16。而当病变发生在左颈总动脉15和左锁骨下动脉16之间时，所述第一接口靠近所述主支架100的近端设置，以使设置所述第一接口上的所述第一分支支架310可植入左锁骨下动脉16，且所述凹陷区101覆盖无名动脉14和左颈总动脉15。本发明的另一些实施例中，所述第一接口也可设置在所述凹陷区101，该覆膜支架可应用于病变发生在主动脉弓的小弯侧的情况。
接下来，本文将对本发明实施例所提供的覆膜支架进行详细介绍。应理解，以下仅对所述覆膜支架的一个优选结构进行描述，其不应对本发明构成限制。还应理解，下文中以所述第一接口设置在所述主支架的凹陷区101以外的侧面上，且所述第一分支支架310用于植入无名动脉14为例进行介绍，但本领域技术人员可对以下描述进行修改，以使其适应所述第一分支支架310植入左锁骨下动脉16时的情形，或所述第一接口设置在所述凹陷区101的情形。
请参考图2、图3、图5、图6a及图6b，所述主支架100的第一支架体包括第一子支架体111和至少两个第二子支架体112。在一些实施例中，所述第一子支架体111的数量为一个，至少两个所述第二子支架体112分别设置在一个所述第一子支架体111的轴向两侧，所述第一子支架体111与两侧的所述第二子支架体112围成了所述凹陷区。在另一些实施例中，所述第一子支架体111的数量为至少两个，至少两个所述第一子支架体111相邻布置，并可以通过金属杆连接，所述金属杆的材料可以与所述第一子支架体111的材料相同；至少两个所述第二子支架体112布置在相邻的至少两个所述第一子支架 体111的轴向两侧。在一些实施例中，所述第一子支架体111的径向截面可呈C形，且所有所述第一子支架体111的开口皆设置在所述第一侧。在另一些实施例中，所述第一子支架体111的横截面可呈D形，此时所述第一子支架体111的数量至少为两个。所述第二子支架体112的横截面可以是圆形或椭圆形。如此，所述第一覆膜120包覆在所述第一子支架体111和所述第二子支架体112的外表面上时，所述主支架100的所述第一侧上形成所述凹陷区101。
进一步地，如图5所示，每个所述第二子支架体112包括多个依次首尾相连的V形杆。如图5中a)所示，在所述主支架100的轴向上，同一个所述第二子支架体112的多个V形杆的长度可相等。或者，如图5中b)所示，在所述主支架100的轴向上，同一个所述第二子支架体112中的至少部分V形杆的长度也可不相等，且优选所述V形杆的长度沿从所述主支架100的所述第二侧到所述第一侧的方向逐渐增大，从而可使得所述第二子支架体112的刚度沿所述第二侧到所述第一侧的方向逐渐增大，以使所述第二侧更容易弯曲而适应主动脉弓的小弯侧。当然，在其他实施例中，也可通过其他方式使得所述第二子支架体112的刚度沿第二侧到第一侧的方向逐渐增大。所述第一子支架体111亦可采用类似于所述第二子支架体112的方式设置。
较佳地，所述主支架100还包括沿所述主支架的轴向延伸的背筋130，所述背筋130设置在所述主支架100的第一侧上。所述主支架100可以包括至少两段背筋130，两段所述背筋130分别设置在所述凹陷区101的轴向两侧，以用于减小所述主支架100的短缩率。所述背筋130可设置在所述第二子支架体112上，且每根所述背筋130至少连接两个所述第二子支架体112。所述背筋130还可以与所述第一覆膜120连接。
请参考图2及图3，在所述主支架100的轴向上所述第一接口设置在所述凹陷区101的外侧，并靠近所述凹陷区101的远端。所述第一接口包括第一窗口和第一定位环211。所述第一窗口开设在所述第一覆膜120上，所述第一定位环211可以由弹性金属丝弯曲而成，所述第一定位环211设置在所述第一窗口处，并与所述第一覆膜120连接。所述第一定位环211用于支撑所述第一窗口，以使所述第一窗口打开，确保血液可从第一窗口流入所述第一分 支支架310，进而流入无名动脉14。
进一步地，所述第一接口上设置有显影元件212，以便于在手术过程中确定第一接口的位置，从而可将所述第一分支支架310准确地植入无名动脉14。可选地，所述显影元件212可为显影条或显影丝。在一些实施例中，所述显影元件212设置在所述第一覆膜120上，并环绕所述第一窗口布置。在另一些实施例中，所述显影元件212缠绕于所述第一定位环211上，如图7所示。
请继续参考图2和图3，并结合图8，所述第一分支支架310的第二支架体可包括多个沿其轴向依次布置的第三子支架体311。位于所述第一分支支架310的近端的至少一个所述第三子支架体311被所述第二覆膜312包覆，并插入所述第一窗口，以与所述第一覆膜120及所述第一定位环211连接，使得所述第一分支支架310的轴线与所述主支架100的轴线垂直。在一些实施例中，如图8中a)所示，位于所述第二支架体的远端的所述第三子支架体311可以完全被所述第二覆膜312包覆。在一些实施例中，位于所述第二支架体的远端的所述第三子支架体311的至少部分区域未被所述第二覆膜312包覆，如图8中b)所示，位于所述第二支架体的远端的一个所述第三子支架体311的至少部分区域未被所述第二覆膜312包覆。在一些实施例中，如图8中c)所示，所述第二支架体的远端的至少两个所述第三子支架体311未被所述第二覆膜312包覆，此时所述第二支架体的远端可跨越无名动脉14的分叉部，在不遮挡无名动脉14分叉部的血流的情况下，进一步增强所述覆膜支架的锚固稳定性。或者，位于所述第二支架体的远端的所述第三子支架体311的至少部分未被所述第二覆膜312包覆的区域为非固定连接。
当所述第一子支架体111的横截面为C形时，所述第二接口设置在所述第一子支架体111的开口处，并包括第二窗口和第二定位环221，所述第二窗口开设在所述第一覆膜120上，第二定位环221设置在所述第二窗口处，并与所述第一覆膜120连接。所述第二定位环221用于支撑所述第二窗口以使所述第二窗口打开，从而血流可顺利地从所述第二接口流出。当所述第二接口处插入所述第二分支支架320，所述第二分支支架320植入左颈总动脉15时，血流经由所述主支架100的内腔和所述第二接口流入第二分支支架320 的内腔，进而保证左颈总动脉15中血流通畅。所述第二定位环221可参照所述第一定位环211设置，此处不再赘述。
所述第二定位环221与任一个所述第一子支架体111之间具有间隙，这样一来，由于所述第一覆膜120由弹性材料制造，因此所述第二接口可相对于所述第一子支架体111活动，以便对所述第二接口的位置进行调整。具体地，本实施例中，所述第二定位环221上的任一点到每个所述第一子支架体的最小距离大于或等于2mm。
在一个替代性的实施例中，当所述第一子支架体111的横截面为D形，且所述第一子支架体111的数量为至少两个时，所述第二接口设置在相邻两个所述第一子支架体111之间，且所述第二定位环221上任一点到每个所述第一子支架体111的距离大于或等于2mm。
由于所述第二接口的位置可相对于所述第一子支架体111进行调整，因而当所述第二接口上设置所述第二分支支架320时，即使所述第二接口未与左颈总动脉15对齐，但通过所述第二接口的位置调整，仍可在第一分支支架310植入无名动脉14的情况下，将所述第二分支支架320植入左颈总动脉15内。当所述第三接口上还设置有所述第三分支支架330时，同样可通过调整所述第三接口的位置，使得三个分支支架分别植入相对应的分支血管中，如图9所示。
请重点参考图10a、图10b，并结合图9，当所述第二接口上设置有所述第二分支支架320时，所述第二接口还包括接合支架222。所述接合支架222设置在所述第二窗口处，并同时与所述第一覆膜120及所述第二定位环221连接，所述接合支架222的轴线垂直于所述主支架100的轴线。如此设置的目的在于，所述主支架100通过所述接合支架222与所述第二分支支架320连接，增大所述第二分支支架320与所述第二接口的接合面积，减少内漏。
可选地，在所述接合支架222的轴向上，所述接合支架222的延伸长度在3mm-10mm之间。如图10a所示，在一些实现方式中，所述接合支架222的一端设置在所述第二窗口处并与所述第一覆膜120及所述第二定位环221连接，另一端延伸至所述主支架100的内腔中，以成为内设的接合支架。在 另一些实现方式中，所述接合支架222的一端设置在所述第二窗口处并与所述第一覆膜120及所述第二定位环221连接，另一端延伸至所述凹陷区101中，以成为外设的接合支架。
请参考图9，所述第三接口包括第三窗口231和内嵌支架232。所述第三窗口231开设在所述主支架的第一覆膜120上，所述内嵌支架232设置在所述主支架100的内腔中，并沿所述主支架100的轴向延伸，且所述内嵌支架232的一端与所述第三窗口231连接，另一端与所述主支架100的内腔连通。所述内嵌支架232包括远端和近端，所述内嵌支架232的远端与所述第三窗口231连接，沿所述内嵌支架232的远端到近端的方向，所述内嵌支架232的内径逐渐减小。
可选地，当所述第三接口上设置所述第三分支支架330时，为确保所述第三分支支架330可顺利地植入左锁骨下动脉16中，对于不同规格的所述覆膜支架而言，将所述覆膜支架植入人体主动脉后，在所述主支架100的横截面上，所述第一子支架体的对称轴与所述主支架的圆心和所述第三接口的圆心的连线的夹角α的范围为0°-45°，如图11所示。
进一步地，所述第二接口和所述第三接口上皆设置有显影元件，以便于将设置在所述第二接口及所述第三接口上的分支支架植入相应的分支动脉。所述第二接口上的所述显影元件可参考所述第一接口设置。所述第三接口的所述第三窗口及所述内嵌支架232上可分别设置所述显影元件。
本发明实施例中，所述主支架100、所述接合支架222及所述内嵌支架232可分别成型后再通过缝合或其他等任何合适的方式进行连接。换句话说，本实施例中，所述主支架100、所述接合支架222及所述内嵌支架232可以为分体结构。在其他实施例中，所述主支架100、所述接合支架222及所述内嵌支架232也可以是一体结构。所有的覆膜皆可采用生物非降解性聚合物例如可膨性聚四氟乙烯(PTFE)、涤纶(PET)、聚酯(polyestPE、聚氨基甲酸乙酯(PU)、真丝等制成。
本发明实施例所提供的覆膜支架通过一输送装置送入患者的主动脉中。请参考图2，所述覆膜支架还包括束缚线400，所述束缚线400用于约束压缩 后的所述主支架100、所述分支支架(即第一分支支架310、第二分支支架320及第三分支支架330)。进一步，位于所述主支架100的近端或远端的所述第二子支架体112的至少部分区域未被所述第一覆膜120包覆。具体地，请参考图5，将同一个所述第二子支架体112的朝向所述主支架100的远端的顶点称之为远端顶点，朝向所述主支架100的近端的顶点称之为近端顶点。请重点参考图12，优选地，位于所述主支架100的远端端部的一个第二子支架体112的至少部分远端顶点未被所述第一覆膜120包覆。类似地，请参考图13，位于所述主支架100的近端端部的一个第二子支架体112的至少部分近端顶点未被所述第一覆膜120包覆。如此，可将所述覆膜支架压缩并安装于所述输送装置上。或者，位于所述主支架100的远端端部的所述第二子支架体112至少部分区域与所述第一覆膜120为非固定连接，以及位于所述主支架100的近端端部的所述第二子支架体的至少部分区域与所述第一覆膜120为非固定连接。
虽然本发明披露如上，但并不局限于此。本领域的技术人员可以对本发明进行各种改动和变型而不脱离本发明的精神和范围。这样，倘若本发明的这些修改和变型属于本发明权利要求及其等同技术的范围之内，则本发明也意图包含这些改动和变型在内。

Claims (23)

  1. 一种覆膜支架，其特征在于，包括主支架、第一接口、第二接口和第一分支支架；所述主支架包括第一支架体和包覆所述第一支架体的第一覆膜，所述第一分支支架包括第二支架体和包覆所述第二支架体的第二覆膜；
    所述第一接口设置在所述主支架的侧面上，并与所述主支架的内腔连通；所述第一分支支架设置在所述第一接口上并向外延伸，且所述第二支架体的靠近所述主支架的一端与所述第二覆膜在周向上至少部分连接；所述主支架的侧面上形成有凹陷区；所述第二接口设置在所述凹陷区上，并与所述主支架的内腔连通。
  2. 根据权利要求1所述的覆膜支架，其特征在于，所述第一接口设置在所述主支架的所述凹陷部以外的侧面上。
  3. 根据权利要求1所述的覆膜支架，其特征在于，在所述主支架的径向上，所述凹陷区的深度大于或等于5mm。
  4. 根据权利要求1所述的覆膜支架，其特征在于，所述第一接口包括第一窗口和第一定位环；所述第一窗口开设在所述主支架的第一覆膜上；所述第一定位环设置在所述第一窗口处，并用于支撑所述第一窗口。
  5. 根据权利要求1-4中任一项所述的覆膜支架，其特征在于，所述覆膜支架还包括第三接口，所述第三接口设置在所述主支架的所述凹陷区，并与所述主支架的内腔连通；所述第一接口、所述第二接口及所述第三接口沿所述主支架的轴向间隔地布置。
  6. 根据权利要求5所述的覆膜支架，其特征在于，所述第二接口包括第二窗口和第二定位环；所述第二窗口开设在所述主支架的第一覆膜上；所述第二定位环设置在所述第二窗口处，并用于支撑所述第二窗口。
  7. 根据权利要求6所述的覆膜支架，其特征在于，所述第一支架体包括一个第一子支架体和至少两个第二子支架体，至少两个所述第二子支架体分别设置在一个所述第一子支架体的轴向两侧，所述第一子支架体与两侧的所述第二子支架体围成了所述凹陷区；或，
    所述第一支架体包括至少两个相邻设置的第一子支架体和至少两个第二子支架体，至少两个所述第二子支架体分别设置在相邻的两个所述第一子支架体的轴向两侧，所述第一子支架体和两侧的所述第二子支架体围成所述凹陷区。
  8. 根据权利要求7所述的覆膜支架，其特征在于，所述第二定位环与任一个所述第一子支架体之间具有间隙；且所述第二定位环上的任一点到每个所述第一子支架体的最小距离大于或等于2mm。
  9. 根据权利要求6所述的覆膜支架，其特征在于，所述第二接口还包括接合支架；所述接合支架设置在所述第二窗口处，并与所述第二定位环连接；所述接合支架的轴线垂直于所述主支架的轴线。
  10. 根据权利要求9所述的覆膜支架，其特征在于，所述接合支架的一端与所述第二定位环连接，另一端延伸至所述凹陷区内或延伸至所述主支架的内腔中。
  11. 根据权利要求9所述的覆膜支架，其特征在于，在所述接合支架的轴向上，所述接合支架的延伸长度为3mm-10mm。
  12. 根据权利要求7所述的覆膜支架，其特征在于，所述第三接口包括第三窗口和内嵌支架；所述第三窗口开设在所述主支架的第一覆膜上；所述内嵌支架设置在所述主支架的内腔中并沿所述主支架的轴向延伸；所述内嵌支架的一端与所述第三窗口连接，另一端与所述主支架的内腔连通。
  13. 根据权利要求12所述的覆膜支架，其特征在于，所述内嵌支架包括远端和近端，所述内嵌支架的远端与所述第三窗口连接，沿所述内嵌支架的远端到近端的方向，所述内嵌支架的内径逐渐减小。
  14. 根据权利要求12所述的覆膜支架，其特征在于，在所述主支架的横截面上，所述第一子支架体的对称轴与所述主支架的圆心和所述第三接口的圆心的连线的夹角范围为0°-45°。
  15. 根据权利要求7所述的覆膜支架，其特征在于，所述主支架具有径向相对的第一侧和第二侧，所述凹陷区设置在所述第一侧；每个所述第一子支架体包括多个依次首尾相连的V形杆，在所述主支架的轴向上，同一个所 述第一子支架体的多个V形杆的长度沿所述第二侧到所述第一侧的方向逐渐增大；和/或，每个所述第二子支架体包括多个依次首尾相连的V形杆，在所述主支架的轴向上，同一个所述第二子支架体的多个V形杆的长度沿所述第二侧到所述第一侧的方向逐渐增大。
  16. 根据权利要求7所述的覆膜支架，其特征在于，所述主支架具有径向相对的第一侧和第二侧，所述凹陷区设置在所述第一侧；所述主支架还包括沿所述主支架的轴向延伸的背筋，所述背筋设置在所述凹陷区的轴向两侧，并与所述第二子支架体和/或所述第一覆膜连接。
  17. 根据权利要求7所述的覆膜支架，其特征在于，所述主支架具有相对的近端和远端，位于所述主支架的近端和/或远端的所述第二子支架体的至少部分区域未被所述第一覆膜包覆。
  18. 根据权利要求7所述的覆膜支架，其特征在于，所述主支架具有相对的近端和远端，位于所述主支架的近端和/或远端的所述第二子支架体的至少部分区域与所述第一覆膜为非固定连接。
  19. 根据权利要求5所述的覆膜支架，其特征在于，所述覆膜支架还包括第二分支支架和/或第三分支支架；所述第二分支支架用于设置在所述第二接口处并与所述第二接口可拆卸连接；所述第三分支支架用于设置在所述第三接口处并与所述第三接口可拆卸连接。
  20. 根据权利要求5所述的覆膜支架，其特征在于，所述主支架具有相对的近端和远端，沿所述主支架的远端到近端的方向，所述主支架包括弓前段、弓部段和弓后段，所述第一接口和所述凹陷区皆设置在所述弓部段上，其中，所述弓前段的轴向长度为2cm-10cm，和/或，所述弓后段的轴向长度为1cm-20cm。
  21. 根据权利要求20所述的覆膜支架，其特征在于，沿所述主支架的远端到近端的方向，所述弓后段的直径逐渐减小。
  22. 根据权利要求5所述的覆膜支架，其特征在于，所述第一接口、所述第二接口及所述第三接口处分别设置有显影元件。
  23. 根据权利要求1所述的覆膜支架，其特征在于，所述第二支架体包 括多个沿其轴向依次布置的第三子支架体，位于所述第二支架体的远端的所述第三子支架体的至少部分区域未被所述第二覆膜包覆；或者，位于所述第二支架体的远端的所述第三子支架体的至少部分未被所述第二覆膜包覆的区域为非固定连接。
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