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WO2025247194A1 - Aortic covered stent - Google Patents

Aortic covered stent

Info

Publication number
WO2025247194A1
WO2025247194A1 PCT/CN2025/097360 CN2025097360W WO2025247194A1 WO 2025247194 A1 WO2025247194 A1 WO 2025247194A1 CN 2025097360 W CN2025097360 W CN 2025097360W WO 2025247194 A1 WO2025247194 A1 WO 2025247194A1
Authority
WO
WIPO (PCT)
Prior art keywords
aortic
stent
sealing layer
layer
elastic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2025/097360
Other languages
French (fr)
Chinese (zh)
Inventor
程龙
尚玉强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Central Hospital Of Wuhan Wuhan No2 Hospital Wuhan Cancer Research Institute
Original Assignee
Central Hospital Of Wuhan Wuhan No2 Hospital Wuhan Cancer Research Institute
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Central Hospital Of Wuhan Wuhan No2 Hospital Wuhan Cancer Research Institute filed Critical Central Hospital Of Wuhan Wuhan No2 Hospital Wuhan Cancer Research Institute
Publication of WO2025247194A1 publication Critical patent/WO2025247194A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Definitions

  • This invention relates to the field of cardiovascular medical device technology, and more particularly to an aortic endovascular stent graft.
  • aortic dissection While interventional treatment of the ascending aorta is also used due to these issues, the unique characteristics of aortic dissection, such as significant morphological changes during cardiac pulsation, a short ascending aorta, a lack of aortic anchorage due to dissection involvement, a short distance between the lesion and the coronary ostia and aortic valves, and involvement of supra-aortic branches, often make conventional aortic stents unsuitable for aortic dissection.
  • the purpose of this invention is to provide an aortic endovascular stent graft that is well adapted to the special morphology and blood flow mechanical characteristics of ascending aortic dissection, has high stability, and provides good sealing to the aortic wall.
  • the present invention adopts the following technical solution:
  • An aortic endovascular stent graft comprising:
  • a sealing layer is spaced out and sleeved around the outer periphery of the support bracket, the sealing layer including a first film;
  • An elastic connecting layer is provided between the support frame and the sealing layer, allowing blood flow between the support frame and the sealing layer;
  • the sealing layer and the elastic connecting layer undergo elastic deformation to ensure that the first membrane remains in close contact with the wall of the aorta adjacent to the sealing layer.
  • the sealing layer further includes a sealing framework, on which the first graft covers the sealing framework.
  • the elastic connection layer comprises multiple layers of elastic skeletons along the axial direction of the supporting stent and the occlusive layer, with each layer of the elastic skeleton connected between the supporting stent and the occlusive layer, and each adjacent pair of elastic skeletons being connected or not connected.
  • each layer of the elastic skeleton includes a plurality of circumferential connecting wires, the two ends of each connecting wire being connected to the supporting stent and the sealing layer respectively, and each pair of adjacent connecting wires being connected or not connected.
  • the connecting wire is either straight or wavy.
  • each layer of the elastic skeleton includes at least one connecting ring, with two opposite points on each connecting ring connected to the supporting stent and the sealing layer, respectively, and each pair of adjacent connecting rings may or may not be connected.
  • the supporting stent includes a supporting framework, at least a portion of which is covered by a second endovascular membrane, the second endovascular membrane being provided with or without openings.
  • the elastic connection layer includes a blood-coagulating material that fills the space between the supporting stent and the sealing layer.
  • an anti-condensation material may be provided between the support bracket and the sealing layer.
  • the supporting stent and the sealing layer are coaxial.
  • aortic endovascular stent graft it also includes an anchoring stent, one end of which is inserted into or fixedly connected to one end of the supporting stent.
  • the anchoring stent can be anchored in the left ventricular outflow tract, the aortic root, the aortic prosthetic valve, the aortic arch, or an artificial blood vessel or stent in the aorta.
  • This invention provides an aortic endovascular stent graft, comprising a supporting stent, a sealing layer, and an elastic connecting layer.
  • the supporting stent provides stable support, enabling the aortic endovascular stent graft to remain relatively stable in the complex blood flow environment of the ascending aorta, without significant swaying or displacement with blood flow.
  • the elastic connecting layer and the sealing layer undergo elastic deformation, contracting or expanding along with the aorta. This ensures that the sealing layer remains firmly attached to the adjacent vessel wall of the aorta, effectively sealing the aortic dissection tear and reducing or preventing blood flow from entering the false lumen through the aortic tear.
  • the weak aortic wall especially the intimal tissue around the tear, causes damage.
  • a portion is diverted between the supporting stent and the sealing layer. This ensures the sealing layer has sufficient space and a stress-bearing environment to contract and expand with the pulsation of the ascending aorta, while also mitigating the impact of blood flow on the sealing layer. This reduces the force transmitted from the sealing layer to the adjacent vessel wall (especially the fragile intimal tissue) due to blood flow impact.
  • This aortic endovascular stent has a high compatibility with the ascending aorta, which undergoes significant morphological variations during pulsation, and is well-suited to the specific morphology and biomechanical characteristics of ascending aortic dissection. Compared to existing aortic endovascular stents, this stent exerts less stress on the ascending aortic vessel wall and intimal flap, effectively reducing damage to the ascending aortic vessel wall caused by the aortic endovascular stent.
  • Figure 1 is a structural schematic diagram of the support bracket and sealing layer provided in an embodiment of the present invention
  • Figure 2 is a schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention.
  • Figure 3 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the distal end of the supporting stent according to an embodiment of the present invention.
  • Figure 4 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the proximal end of the support stent according to an embodiment of the present invention.
  • Figure 5 is a second structural schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention.
  • Figure 6 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the distal end of the supporting stent according to an embodiment of the present invention
  • Figure 7 is a schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention.
  • Figure 8 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the proximal end of the supporting stent according to an embodiment of the present invention
  • Figure 9 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);
  • Figure 10 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);
  • Figure 11 is a top view three of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);
  • Figure 12 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);
  • Figure 13 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);
  • Figure 14 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);
  • Figure 15 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);
  • Figure 16 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);
  • Figure 17 is a cross-sectional view of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);
  • Figure 18 is a cross-sectional view of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);
  • Figure 19 is a cross-sectional view three of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);
  • Figure 20 is a cross-sectional view four of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown).
  • Support bracket 11. Support skeleton; 12. Second film; 2. Sealing layer; 21. Sealing skeleton; 22. First film; 3. Elastic connecting layer; 31. Elastic skeleton; 311. Connecting wire; 312. Connecting ring; 4. Anchor bracket.
  • the terms "connected,” “linked,” and “fixed” should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components.
  • Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.
  • the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, “above,” “over,” and “on top” of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below,” “below,” and “under” the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.
  • this embodiment provides an aortic endovascular stent graft, which is applicable to the treatment of the entire aorta, especially the ascending aorta.
  • the aortic endovascular stent graft includes a supporting stent 1, a sealing layer 2, and an elastic connecting layer 3.
  • the sealing layer 2 is spaced around the periphery of the supporting stent 1 and includes a first covering 22.
  • the elastic connecting layer 3 connects the supporting stent 1 and the sealing layer 2, allowing blood flow between the supporting stent 1 and the sealing layer 2.
  • the sealing layer 2 and the elastic connecting layer 3 undergo elastic deformation, so that the sealing layer 2 always adheres tightly to the aorta and the vessel wall adjacent to the sealing layer.
  • the stent 1 provides stable support, enabling the aortic endovascular stent graft to remain stable in the ascending aorta under complex blood flow conditions.
  • the elastic connecting layer 3 and the sealing layer 2 undergo elastic deformation, contracting or expanding along with the ascending aorta.
  • sealing layer 2 remains tightly attached to the wall adjacent to the ascending aorta and the sealing layer (including the normal ascending aortic vessel wall and the torn intima patch tissue), thus sealing the intima tear of the ascending aorta.
  • This prevents or reduces blood flow from entering the false lumen through the aortic tear and effectively prevents the sealing layer 2 from damaging the fragile ascending aorta.
  • the aorta, especially the torn intima suffers damage.
  • blood flow is shunted as it passes through the aortic stent graft, with some entering between the supporting stent 1 and the sealing layer 2.
  • sealing layer 2 has sufficient space and a stress-bearing environment to contract and expand with the pulsation of the ascending aorta, while also mitigating the impact of blood flow on the sealing layer 2.
  • This reduces the force transmitted from the sealing layer 2 to the adjacent vessel wall (especially the fragile dissected intima) due to blood flow impact, and also reduces the lateral impact on the aortic stent graft caused by blood flow along the vessel axis, thus reducing the impact of blood flow on the stability of the aortic stent graft.
  • This aortic stent graft has a high compatibility with the ascending aorta, which undergoes significant morphological variations during pulsation, and is well-suited to the special morphology and biomechanical characteristics of ascending aortic dissection. Compared to existing arterial stents, this aortic stent graft exerts less stress on the ascending aortic vessel wall and intima, effectively reducing damage to the ascending aortic vessel wall caused by the aortic stent graft.
  • the sealing layer 2 further includes a sealing skeleton 21, and the first covering film 22 covers the sealing skeleton 21. That is, the elastic connecting layer 3 can be connected between the sealing skeleton 21 and the support bracket 1, or the first covering film 22 can be directly sleeved on the outside of the elastic connecting layer 3.
  • the support stent 1 and the sealing layer 2 are coaxial.
  • the support stent 1 is cylindrical
  • the sealing layer 2 is cylindrical
  • the cross-sections of the support stent 1 and the sealing layer 2 are two concentric circles.
  • the coaxial arrangement of the support stent 1 and the sealing layer 2 ensures more uniform circumferential stress on both, and also ensures more uniform stress on the periphery of the ascending aorta, preventing damage caused by excessive stress in any one area of the ascending aorta.
  • the support stent 1 and the sealing layer 2 may be non-coaxial, depending on actual needs.
  • the support frame 1 includes a support skeleton 11, the stiffness of which is greater than that of the closing skeleton 21. That is, the elastic modulus of the support skeleton 11 is greater than that of the closing skeleton 21, and the closing skeleton 21 has better flexibility compared to the support skeleton 11.
  • the stiffer support skeleton 11 provides stable support, with less deformation under stress, and is less prone to large deformation with the pulsation of the ascending aorta.
  • the less stiff closing skeleton 21 has good flexibility and can deform closely with the pulsation of the ascending aorta, thus ensuring that the closing layer 2 always adheres tightly to the wall adjacent to the ascending aorta and the closing layer.
  • the stiffness of the support skeleton 11 may be uniform or non-uniform; for example, the stiffness of the support skeleton 11 at a certain part with greater blood flow impact may be less than the stiffness of other parts, in order to mitigate the impact of blood flow.
  • Both the supporting frame 11 and the closed frame 21 are made of metal, such as stainless steel or nickel-titanium shape memory alloy.
  • the material of the supporting frame 11 or the closed frame 21 is selected according to the required flexibility.
  • the first coating 22 is made of one of polyurethane, polytetrafluoroethylene, silicone, or polyester, depending on the actual needs.
  • the supporting frame 11 and the closed frame 21 can also be made of other materials, such as absorbent materials.
  • the stent 1 further includes a second membrane 12, and at least a portion of the supporting framework 11 is covered by the second membrane 12.
  • the second membrane 12 creates a blood flow channel within the stent 1, and a blood flow channel is formed between the stent 1 and the sealing layer 2.
  • the second membrane 12 is made of one of polyurethane, polytetrafluoroethylene, silicone, or polyester, depending on the actual needs.
  • the elastic connection layer 3 includes multiple layers of elastic skeleton 31.
  • Each layer of elastic skeleton 31 is connected between the support stent 1 and the sealing layer 2, and adjacent layers of elastic skeleton 31 may or may not be connected.
  • the multiple layers of elastic skeleton 31 make the connection between the support stent 1 and the sealing layer 2 more stable. That is, the support stent 1 provides good support for the entire section of the sealing layer 2, allowing the entire section of the sealing layer 2 to undergo elastic deformation with the pulsation of the ascending aorta. This allows the entire section of the sealing layer 2 to closely adhere to the aortic vessel wall (including the intima-lamellae tissue) adjacent to the sealing layer 2 in the ascending aorta.
  • each elastic skeleton 31 includes a plurality of circumferentially arranged connecting wires 311.
  • Each connecting wire 311 is connected at both ends to the support stent 1 and the closure layer 2, respectively. Adjacent connecting wires 311 may or may not be connected.
  • the connecting wires 311 are shape-memory metal wires, capable of bending and deforming under stress and returning to their initial state after stress is released.
  • the circumferential arrangement of the connecting wires 311 ensures relatively uniform stress distribution on the closure layer 2 and the support stent 1. When the ascending aorta pulsates, the closure layer 2 contracts under stress or expands under elastic recovery.
  • the connecting wires 311 elastically deform with the contraction or rebound of the closure layer 2, bending or rebounding accordingly.
  • the connecting wires 311 not only provide good support for the closure layer 2 but also provide sufficient rebound force, allowing the closure layer 2 to rebound instantaneously. This results in better closure stability and reliability of the aortic stent graft for the ascending aorta.
  • the connecting wire 311 is straight or wavy.
  • the wavy connecting wire 311 can be formed by several V-shaped filaments or several arc-shaped filaments, and the specific form is not limited here.
  • each connecting wire 311 is consistent with or at an angle to the radial direction of the support bracket 1, and the connecting wires 311 of the upper layer elastic skeleton 31 and the connecting wires 311 of the lower layer elastic skeleton 31 can be connected or not connected, and two adjacent connecting wires 311 in the same layer can be connected or not connected, depending on the actual needs.
  • This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.
  • the elastic connecting layer 3 includes a blood-coagulating material, which fills the space between the supporting stent 1 and the sealing layer 2.
  • the blood-coagulating material and the elastic skeleton 31 can be provided simultaneously or selectively.
  • an anticoagulant material may be disposed between the stent 1 and the sealing layer 2.
  • the anticoagulant material can effectively prevent blood clots from forming and entering the blood flow channels within the stent 1, or even flowing into distal blood flow cavities, causing thrombosis-related events.
  • the anticoagulant material may be, but is not limited to, heparin.
  • an anticoagulant material, such as heparin may be coated onto the opposing surfaces of the stent 1 and/or the sealing layer 2.
  • the second cover 12 has an opening, preferably located at the distal end near the support stent 1. This allows blood flow between the support stent 1 and the sealing layer 2 to return to the support stent 1, preventing blood from accumulating and impacting the sealing layer 2 or causing thrombus formation when blood flows between the support stent 1 and the sealing layer 2 after the distal portion of the support stent 1 and the sealing layer 2 is sealed. This further improves the reliability and safety of the aortic covered stent.
  • the opening on the second cover 12 can also be located at the proximal end near the support stent 1 or at other locations, depending on actual needs; and the number and size of the openings are not limited here.
  • This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.
  • the aortic endovascular stent graft further includes an anchoring stent 4.
  • One end of the anchoring stent 4 is inserted into or fixedly connected to one end of the supporting stent 1.
  • the anchoring stent 4 can be anchored in the left ventricular outflow tract, aortic root, aortic prosthetic valve, aortic arch, or aortic prosthetic blood vessel or stent.
  • the ascending aorta and other parts of the aorta can be treated simultaneously through the anchoring stent 4 and the aortic endovascular stent graft.
  • aortic prosthetic valves, aortic prosthetic blood vessels, or stents are relatively mature existing technologies, as are the placement of stents in the left ventricular outflow tract, aortic root, and aortic arch. Therefore, they will not be described in detail here.
  • the anchoring stent 4 is anchored in the aortic arch.
  • the proximal end of the anchoring stent 4 is inserted into or integrally connected to the distal end of the support frame 11.
  • the distal end of the support frame 11 is inserted into the proximal end of the anchoring stent 4, or the proximal end of the anchoring stent 4 is inserted into the distal end of the support frame 11.
  • the portion of the support frame 11 into which the anchoring stent 4 is inserted is a bare stent, i.e., it is not covered by the second cover 12 or the second cover 12 has an opening to allow blood flow from between the support stent 1 and the sealing layer 2.
  • the anchoring stent 4 can be a bare stent or a covered stent, and the length of the anchoring stent 4 is set according to actual needs.
  • the anchoring stent 4 is anchored in the left ventricular outflow tract, the aortic root, or an autologous or artificial aortic valve.
  • the distal end of the anchoring stent 4 is inserted into or integrally connected to the proximal end of the support frame 11.
  • the proximal end of the support frame 11 is inserted into the distal end of the anchoring stent 4, or the distal end of the anchoring stent 4 is inserted into the proximal end of the support frame 11.
  • the portion of the support frame 11 into which the anchoring stent 4 is inserted is a bare stent, i.e., it is not covered by the second covering 12 or the second covering 12 has openings to allow blood flow between the support stent 1 and the sealing layer 2.
  • the anchoring stent 4 can be a bare stent or a covered stent, and the length of the anchoring stent 4 is set according to actual needs.
  • the anchoring stent 4 is not limited to only one; two anchoring stents 4 can also be provided, with the two anchoring stents 4 respectively connected to both ends of the support stent 1.
  • This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.
  • each layer of elastic skeleton 31 includes at least one connecting ring 312. Two opposite points on each connecting ring 312 are connected to the support stent 1 and the sealing layer 2, respectively. Each pair of adjacent connecting rings 312 may or may not be connected.
  • the connecting ring 312 is formed of shape memory metal wire. Optionally, the shape memory metal wire is straight or wavy.
  • the connecting ring 312 has excellent deformation performance. When the ascending aorta contracts, the sealing layer 2 contracts under force and transmits the force to the connecting ring 312. The connecting ring 312 deforms under force, converting most of the force into deformation, while the remaining small portion of the force is transmitted to the support stent 1.
  • the support stent 1 experiences less force with the pulsation of the ascending aorta, making it less prone to large deformation and displacement, thus ensuring the stability of the aortic stent graft.
  • the deformation path of the connecting ring 312 under force is basically stable; that is, the connecting ring 312 deforms along its radial direction, effectively avoiding interference caused by axial deformation of each layer of elastic skeleton 31. Simultaneously, the connecting ring 312 can quickly rebound after the force is released.
  • each connecting ring 312 is located between the support stent 1 and the sealing layer 2, that is, the support stent 1 and the connecting ring 312 are adjacent to each other and do not overlap in space; or the support stent 1 is located within each connecting ring 312, and most of the force applied by the sealing layer 2 is absorbed and converted by the connecting ring 312, and very little of it is transmitted to the support stent 1, so that the support stent 1 has better stability, thereby ensuring the stability of the aortic endovascular stent graft.
  • the radial direction of the connecting ring 312 of each layer of elastic skeleton 31 can be consistent with the radial direction of the support bracket 1, or it can be set at an angle. That is, the connecting ring 312 is set at an angle relative to the support bracket 1 and the closing layer 2, and the tilt direction of the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 can be the same or different, and the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 can be connected or not connected, depending on the actual needs.
  • one connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 are connected, and the radial directions of the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 are set at an angle, one connecting ring 312 of the upper layer of elastic skeleton 31 and one connecting ring 312 of the lower layer of elastic skeleton 31 form a non-planar "8" shape.
  • the two adjacent connecting rings 312 of each layer of elastic skeleton 31 can be connected to each other or not connected, depending on the actual needs.
  • This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.
  • several layers of elastic skeleton 31 include a plurality of connecting wires 311 arranged in a ring, and several other layers of elastic skeleton 31 include connecting rings 312.
  • the structure and arrangement of the connecting wires 311 are the same as in Embodiment 1, and the structure and arrangement of the connecting rings 312 are the same as in Embodiment 4.

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  • Oral & Maxillofacial Surgery (AREA)
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  • Prostheses (AREA)

Abstract

The present invention relates to the technical field of medical devices for cardiovascular diseases. Disclosed is an aortic covered stent. The aortic covered stent comprises a supporting stent, a sealing layer, and an elastic connecting layer. The sealing layer is spaced apart from and sleeved on the outer periphery of the supporting stent. The sealing layer comprises a first covering film. The elastic connecting layer is connected between the supporting stent and the sealing layer, such that blood flow can circulate between the supporting stent and the sealing layer. With the pulsation of the aorta, the sealing layer and the elastic connecting layer undergo elastic deformation, so that the first covering film is always closely attached to the aortic blood vessel wall adjacent to the sealing layer. The aortic covered stent can be well adapted to the special morphology of ascending aortic dissection and the mechanical characteristics of blood flow, offering high stability and exhibiting good sealing performance on the ascending aortic wall.

Description

一种主动脉覆膜支架A type of aortic endovascular stent 技术领域Technical Field

本发明涉及心血管疾病医疗设备技术领域,尤其涉及一种主动脉覆膜支架。This invention relates to the field of cardiovascular medical device technology, and more particularly to an aortic endovascular stent graft.

背景技术Background Technology

基于当前技术,对于累及升主动脉的夹层,大多数治疗为外科手术,即对于受累的升主动脉段,予以外科人工血管置换。但该手术大,吻合困难,手术需体外循环等,创伤大,并发症多。基于上述问题,也有予以升主动脉的介入治疗,但由于升主动脉夹层的病变特殊性,如升主动脉随心脏搏动时,形态变化大,升主动脉较短或者夹层累及升主动脉致升主动脉锚定区缺乏,升主动脉病变距离冠脉开口及主动脉瓣膜距离短,夹层累及弓上分支等因素,现有的常规主动脉支架往往难以应用于升主动脉夹层。Based on current technology, most treatments for aortic dissection involving the ascending aorta involve surgery, specifically surgical replacement of the affected segment with a surgical prosthetic vascular graft. However, this surgery is extensive, involves complex anastomosis, requires cardiopulmonary bypass, and is highly invasive with numerous complications. While interventional treatment of the ascending aorta is also used due to these issues, the unique characteristics of aortic dissection, such as significant morphological changes during cardiac pulsation, a short ascending aorta, a lack of aortic anchorage due to dissection involvement, a short distance between the lesion and the coronary ostia and aortic valves, and involvement of supra-aortic branches, often make conventional aortic stents unsuitable for aortic dissection.

因此,亟需一种主动脉覆膜支架来解决上述问题。Therefore, there is an urgent need for an aortic endovascular stent graft to solve the above problems.

发明内容Summary of the Invention

基于以上所述,本发明的目的在于提供一种主动脉覆膜支架,能较好地适用于升主动脉夹层的特殊形态及血流的力学特征,稳定性较高,对主动脉壁的封闭性较佳。Based on the above, the purpose of this invention is to provide an aortic endovascular stent graft that is well adapted to the special morphology and blood flow mechanical characteristics of ascending aortic dissection, has high stability, and provides good sealing to the aortic wall.

为达上述目的,本发明采用以下技术方案:To achieve the above objectives, the present invention adopts the following technical solution:

一种主动脉覆膜支架,包括:An aortic endovascular stent graft, comprising:

支撑支架;Support bracket;

封闭层,间隔套设在所述支撑支架的外周,所述封闭层包括第一覆膜;A sealing layer is spaced out and sleeved around the outer periphery of the support bracket, the sealing layer including a first film;

弹性连接层,连接在所述支撑支架和所述封闭层之间,血流能在所述支撑支架和所述封闭层之间流通;An elastic connecting layer is provided between the support frame and the sealing layer, allowing blood flow between the support frame and the sealing layer;

随主动脉搏动,所述封闭层和所述弹性连接层产生弹性形变,以使所述第一覆膜始终紧贴所述主动脉与所述封闭层相邻的壁。As the aorta pulsates, the sealing layer and the elastic connecting layer undergo elastic deformation to ensure that the first membrane remains in close contact with the wall of the aorta adjacent to the sealing layer.

作为一种主动脉覆膜支架的优选方案,所述封闭层还包括封闭骨架,所述第一覆膜包覆在所述封闭骨架上。As a preferred embodiment of an aortic endovascular stent graft, the sealing layer further includes a sealing framework, on which the first graft covers the sealing framework.

作为一种主动脉覆膜支架的优选方案,在所述支撑支架和所述封闭层的轴向上,所述弹性连接层包括多层弹性骨架,每层所述弹性骨架连接在所述支撑支架和所述封闭层之间,每相邻两层所述弹性骨架之间连接或不连接。As a preferred embodiment of aortic endovascular stent graft, the elastic connection layer comprises multiple layers of elastic skeletons along the axial direction of the supporting stent and the occlusive layer, with each layer of the elastic skeleton connected between the supporting stent and the occlusive layer, and each adjacent pair of elastic skeletons being connected or not connected.

作为一种主动脉覆膜支架的优选方案,每层所述弹性骨架包括环设的多个连接丝,每个所述连接丝的两端分别与所述支撑支架和所述封闭层连接,每相邻两个所述连接丝之间连接或不连接。As a preferred embodiment of aortic endovascular stent graft, each layer of the elastic skeleton includes a plurality of circumferential connecting wires, the two ends of each connecting wire being connected to the supporting stent and the sealing layer respectively, and each pair of adjacent connecting wires being connected or not connected.

作为一种主动脉覆膜支架的优选方案,所述连接丝呈直线形或波浪形。As a preferred embodiment of aortic endovascular stent graft, the connecting wire is either straight or wavy.

作为一种主动脉覆膜支架的优选方案,每层所述弹性骨架包括至少一个连接环,每个所述连接环上的相对两点分别与所述支撑支架和所述封闭层连接,每相邻两个所述连接环之间连接或不连接。As a preferred embodiment of aortic endovascular stent graft, each layer of the elastic skeleton includes at least one connecting ring, with two opposite points on each connecting ring connected to the supporting stent and the sealing layer, respectively, and each pair of adjacent connecting rings may or may not be connected.

作为一种主动脉覆膜支架的优选方案,所述支撑支架包括支撑骨架,所述支撑骨架的至少部分包覆有第二覆膜,所述第二覆膜上设有开孔或不开孔。As a preferred embodiment of an aortic endovascular stent graft, the supporting stent includes a supporting framework, at least a portion of which is covered by a second endovascular membrane, the second endovascular membrane being provided with or without openings.

作为一种主动脉覆膜支架的优选方案,所述弹性连接层包括血液促凝材料,所述血液促凝材料填充在所述支撑支架和所述封闭层之间;As a preferred embodiment of an aortic endovascular stent graft, the elastic connection layer includes a blood-coagulating material that fills the space between the supporting stent and the sealing layer.

或所述支撑支架和所述封闭层之间设置有抗凝材料。Alternatively, an anti-condensation material may be provided between the support bracket and the sealing layer.

作为一种主动脉覆膜支架的优选方案,所述支撑支架和所述封闭层同轴。As a preferred embodiment of aortic endovascular stent graft, the supporting stent and the sealing layer are coaxial.

作为一种主动脉覆膜支架的优选方案,还包括锚定支架,所述锚定支架的一端与所述支撑支架的一端插接或固定连接,所述锚定支架能锚定在左室流出道、主动脉根部、主动脉人工瓣膜、主动脉弓部、主动脉的人工血管或支架。As a preferred embodiment of aortic endovascular stent graft, it also includes an anchoring stent, one end of which is inserted into or fixedly connected to one end of the supporting stent. The anchoring stent can be anchored in the left ventricular outflow tract, the aortic root, the aortic prosthetic valve, the aortic arch, or an artificial blood vessel or stent in the aorta.

本发明的有益效果为:The beneficial effects of this invention are as follows:

本发明提供一种主动脉覆膜支架,该主动脉覆膜支架包括支撑支架、封闭层和弹性连接层,通过支撑支架提供稳定的支撑作用,使得该主动脉覆膜支架能在升主动脉复杂的血流环境下保持相对稳定,不随血流严重摆动或移位;主动脉搏动时,弹性连接层和封闭层产生弹性形变,随着主动脉一起收缩或扩张,使得封闭层始终紧贴主动脉相邻血管壁,即封闭主动脉夹层破口,减少或避免血流经由主动脉破口进入假腔,且能有效避免封闭层对脆弱的主动脉壁、尤其是破口周围夹层内膜组织造成损伤;同时,血流经过该主动脉覆膜支架时分流,部分进入支撑支架和封闭层之间,既能保证封闭层具有足够的空间和受力环境随升主动脉搏动收缩扩张,也能减缓血流对封闭层的冲击,从而减少封闭层因血流冲击而传导至相邻血管壁(尤其是脆弱的夹层内膜组织)的作用力,还能减少因血流在沿血管轴向行进时,对于覆膜支架所造成的侧向冲击,从而减少血流对于覆膜支架稳定性的影响。该主动脉覆膜支架与主动脉中搏动时产生较大形态变异的升主动脉适配度较高,能较好地适用于升主动脉夹层的特殊形态及血流的力学特征,相较于采用现有的主动脉覆膜支架,该主动脉覆膜支架对升主动脉血管壁及内膜片的应力作用较小,能有效降低主动脉覆膜支架对于升主动脉血管壁造成损伤。This invention provides an aortic endovascular stent graft, comprising a supporting stent, a sealing layer, and an elastic connecting layer. The supporting stent provides stable support, enabling the aortic endovascular stent graft to remain relatively stable in the complex blood flow environment of the ascending aorta, without significant swaying or displacement with blood flow. During aortic pulsation, the elastic connecting layer and the sealing layer undergo elastic deformation, contracting or expanding along with the aorta. This ensures that the sealing layer remains firmly attached to the adjacent vessel wall of the aorta, effectively sealing the aortic dissection tear and reducing or preventing blood flow from entering the false lumen through the aortic tear. Furthermore, it effectively prevents the sealing layer from damaging fragile structures. The weak aortic wall, especially the intimal tissue around the tear, causes damage. Simultaneously, as blood flows through this aortic endovascular stent, a portion is diverted between the supporting stent and the sealing layer. This ensures the sealing layer has sufficient space and a stress-bearing environment to contract and expand with the pulsation of the ascending aorta, while also mitigating the impact of blood flow on the sealing layer. This reduces the force transmitted from the sealing layer to the adjacent vessel wall (especially the fragile intimal tissue) due to blood flow impact. It also reduces the lateral impact on the stent caused by blood flow along the vessel axis, thus minimizing the influence of blood flow on the stability of the stent. This aortic endovascular stent has a high compatibility with the ascending aorta, which undergoes significant morphological variations during pulsation, and is well-suited to the specific morphology and biomechanical characteristics of ascending aortic dissection. Compared to existing aortic endovascular stents, this stent exerts less stress on the ascending aortic vessel wall and intimal flap, effectively reducing damage to the ascending aortic vessel wall caused by the aortic endovascular stent.

附图说明Attached Figure Description

为了更清楚地说明本发明实施例中的技术方案,下面将对本发明实施例描述中所需要使用的附图作简单的介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据本发明实施例的内容和这些附图获得其他的附图。To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

图1是本发明实施例提供的支撑支架和封闭层的结构示意图;Figure 1 is a structural schematic diagram of the support bracket and sealing layer provided in an embodiment of the present invention;

图2是本发明实施例提供的支撑骨架和封闭骨架的结构示意图一;Figure 2 is a schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention;

图3是本发明实施例提供的锚定支架连接于支撑支架远端的主动脉覆膜支架的结构示意图一;Figure 3 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the distal end of the supporting stent according to an embodiment of the present invention.

图4是本发明实施例提供的锚定支架连接于支撑支架近端的主动脉覆膜支架的结构示意图一;Figure 4 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the proximal end of the support stent according to an embodiment of the present invention.

图5是本发明实施例提供的支撑骨架和封闭骨架的结构示意图二;Figure 5 is a second structural schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention;

图6是本发明实施例提供的锚定支架连接于支撑支架远端的主动脉覆膜支架的结构示意图二;Figure 6 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the distal end of the supporting stent according to an embodiment of the present invention;

图7是本发明实施例提供的支撑骨架和封闭骨架的结构示意图三;Figure 7 is a schematic diagram of the supporting frame and the closed frame provided in an embodiment of the present invention;

图8是本发明实施例提供的锚定支架连接于支撑支架近端的主动脉覆膜支架的结构示意图三;Figure 8 is a schematic diagram of the structure of the aortic endovascular stent graft connected to the proximal end of the supporting stent according to an embodiment of the present invention;

图9是本发明实施例一提供的主动脉覆膜支架的俯视图一(未示出锚定支架);Figure 9 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);

图10是本发明实施例一提供的主动脉覆膜支架的俯视图二(未示出锚定支架);Figure 10 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);

图11是本发明实施例一提供的主动脉覆膜支架的俯视图三(未示出锚定支架);Figure 11 is a top view three of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);

图12是本发明实施例一提供的主动脉覆膜支架的俯视图四(未示出锚定支架);Figure 12 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);

图13是本发明实施例一提供的主动脉覆膜支架的俯视图五(未示出锚定支架);Figure 13 is a top view of the aortic endovascular stent graft provided in Embodiment 1 of the present invention (anchoring stent not shown);

图14是本发明实施例四提供的主动脉覆膜支架的俯视图一(未示出锚定支架);Figure 14 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);

图15是本发明实施例四提供的主动脉覆膜支架的俯视图二(未示出锚定支架);Figure 15 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);

图16是本发明实施例四提供的主动脉覆膜支架的俯视图三(未示出锚定支架);Figure 16 is a top view of the aortic endovascular stent graft provided in Embodiment 4 of the present invention (anchoring stent not shown);

图17是本发明实施例提供的主动脉覆膜支架的剖面图一(未示出锚定支架);Figure 17 is a cross-sectional view of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);

图18是本发明实施例提供的主动脉覆膜支架的剖面图二(未示出锚定支架);Figure 18 is a cross-sectional view of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);

图19是本发明实施例提供的主动脉覆膜支架的剖面图三(未示出锚定支架);Figure 19 is a cross-sectional view three of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown);

图20是本发明实施例提供的主动脉覆膜支架的剖面图四(未示出锚定支架)。Figure 20 is a cross-sectional view four of the aortic endovascular stent graft provided in an embodiment of the present invention (anchoring stent not shown).

图中:
1、支撑支架;11、支撑骨架;12、第二覆膜;2、封闭层;21、封闭骨架;22、第一覆
膜;3、弹性连接层;31、弹性骨架;311、连接丝;312、连接环;4、锚定支架。
In the picture:
1. Support bracket; 11. Support skeleton; 12. Second film; 2. Sealing layer; 21. Sealing skeleton; 22. First film; 3. Elastic connecting layer; 31. Elastic skeleton; 311. Connecting wire; 312. Connecting ring; 4. Anchor bracket.

具体实施方式Detailed Implementation

下面结合附图和实施例对本发明作进一步的详细说明。可以理解的是,此处所描述的具体实施例仅仅用于解释本发明,而非对本发明的限定。另外还需要说明的是,为了便于描述,附图中仅示出了与本发明相关的部分而非全部结构。The present invention will now be described in further detail with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and not intended to limit it. Furthermore, it should be noted that, for ease of description, the accompanying drawings show only the parts relevant to the present invention, and not all of the structures.

在本发明的描述中,除非另有明确的规定和限定,术语“相连”、“连接”、“固定”应做广义理解,例如,可以是固定连接,也可以是可拆卸连接,或成一体;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,可以具体情况理解上述术语在本发明中的具体含义。In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

在本发明中,除非另有明确的规定和限定,第一特征在第二特征之“上”或之“下”可以包括第一和第二特征直接接触,也可以包括第一和第二特征不是直接接触而是通过它们之间的另外的特征接触。而且,第一特征在第二特征“之上”、“上方”和“上面”包括第一特征在第二特征正上方和斜上方,或仅仅表示第一特征水平高度高于第二特征。第一特征在第二特征“之下”、“下方”和“下面”包括第一特征在第二特征正下方和斜下方,或仅仅表示第一特征水平高度小于第二特征。In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

在本实施例的描述中,术语“上”、“下”、“左”、“右”等方位或位置关系为基于附图所示的方位或位置关系,仅是为了便于描述和简化操作,而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。在本发明的描述中,除非另有说明,“多个”的含义是两个或两个以上。此外,术语“第一”、“第二”仅仅用于在描述上加以区分,并没有特殊的含义。In the description of this embodiment, the terms "upper," "lower," "left," and "right," etc., refer to the orientation or positional relationship shown in the accompanying drawings. They are used solely for ease of description and simplification of operation, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the present invention. In the description of the present invention, unless otherwise stated, "a plurality of" means two or more. Furthermore, the terms "first" and "second" are merely used for descriptive distinction and have no special meaning.

实施例一Example 1

如图1至图20所示,本实施例提供一种主动脉覆膜支架,可适用于主动脉全段治疗,尤其适用于升主动脉的治疗。具体地,该主动脉覆膜支架包括支撑支架1、封闭层2和弹性连接层3,封闭层2间隔套设在支撑支架1的外周,封闭层2包括第一覆膜22,弹性连接层3连接在支撑支架1和封闭层2之间,血流能在支撑支架1和封闭层2之间流通,随主动脉搏动,封闭层2和弹性连接层3产生弹性形变,以使封闭层2始终紧贴主动脉与封闭层相邻的血管壁。以该主动脉覆膜支架适用于升主动脉为例,通过支撑支架1提供稳定的支撑作用,使得该主动脉覆膜支架能在复杂的血流环境下稳定在升主动脉;升主动脉搏动时,弹性连接层3和封闭层2产生弹性形变,随着升主动脉一起收缩或扩张,使得封闭层2始终紧贴升主动脉与封闭层相邻的壁(包括正常的升主动脉血管壁以及撕裂的内膜片组织),即可封闭升主动脉的内膜破口,避免或减少血流经由主动脉破口进入假腔,且能有效避免封闭层2对脆弱的升主动脉尤其是撕裂的内膜片组织造成损伤;同时,血流经过该主动脉覆膜支架时分流,部分进入支撑支架1和封闭层2之间,既能保证封闭层2具有足够的空间和受力环境随升主动脉搏动收缩扩张,也能减缓血流对封闭层2的冲击,从而减少封闭层2因血流冲击而传导至相邻血管壁(尤其是脆弱的夹层内膜组织)的作用力,还减少因血流在沿血管轴向行进时,对于主动脉覆膜支架所造成的侧向冲击,从而减少血流对于主动脉覆膜支架稳定性的影响。该主动脉覆膜支架与主动脉中搏动时产生较大形态变异的升主动脉适配度较高,能较好的适用于升主动脉夹层的特殊形态及血流的力学特征,相较于采用现有的动脉支架,该主动脉覆膜支架对升主动脉血管壁及内膜片的应力作用较小,能有效降低主动脉覆膜支架对于升主动脉血管壁造成损伤。As shown in Figures 1 to 20, this embodiment provides an aortic endovascular stent graft, which is applicable to the treatment of the entire aorta, especially the ascending aorta. Specifically, the aortic endovascular stent graft includes a supporting stent 1, a sealing layer 2, and an elastic connecting layer 3. The sealing layer 2 is spaced around the periphery of the supporting stent 1 and includes a first covering 22. The elastic connecting layer 3 connects the supporting stent 1 and the sealing layer 2, allowing blood flow between the supporting stent 1 and the sealing layer 2. With the pulsation of the aorta, the sealing layer 2 and the elastic connecting layer 3 undergo elastic deformation, so that the sealing layer 2 always adheres tightly to the aorta and the vessel wall adjacent to the sealing layer. Taking the aortic endovascular stent graft applicable to the ascending aorta as an example, the stent 1 provides stable support, enabling the aortic endovascular stent graft to remain stable in the ascending aorta under complex blood flow conditions. When the ascending aorta pulsates, the elastic connecting layer 3 and the sealing layer 2 undergo elastic deformation, contracting or expanding along with the ascending aorta. This ensures that the sealing layer 2 remains tightly attached to the wall adjacent to the ascending aorta and the sealing layer (including the normal ascending aortic vessel wall and the torn intima patch tissue), thus sealing the intima tear of the ascending aorta. This prevents or reduces blood flow from entering the false lumen through the aortic tear and effectively prevents the sealing layer 2 from damaging the fragile ascending aorta. The aorta, especially the torn intima, suffers damage. Simultaneously, blood flow is shunted as it passes through the aortic stent graft, with some entering between the supporting stent 1 and the sealing layer 2. This ensures that the sealing layer 2 has sufficient space and a stress-bearing environment to contract and expand with the pulsation of the ascending aorta, while also mitigating the impact of blood flow on the sealing layer 2. This reduces the force transmitted from the sealing layer 2 to the adjacent vessel wall (especially the fragile dissected intima) due to blood flow impact, and also reduces the lateral impact on the aortic stent graft caused by blood flow along the vessel axis, thus reducing the impact of blood flow on the stability of the aortic stent graft. This aortic stent graft has a high compatibility with the ascending aorta, which undergoes significant morphological variations during pulsation, and is well-suited to the special morphology and biomechanical characteristics of ascending aortic dissection. Compared to existing arterial stents, this aortic stent graft exerts less stress on the ascending aortic vessel wall and intima, effectively reducing damage to the ascending aortic vessel wall caused by the aortic stent graft.

可选地,封闭层2还包括封闭骨架21,第一覆膜22包覆在封闭骨架21上。即弹性连接层3能连接在封闭骨架21和支撑支架1之间,或第一覆膜22能直接套设在弹性连接层3外。Optionally, the sealing layer 2 further includes a sealing skeleton 21, and the first covering film 22 covers the sealing skeleton 21. That is, the elastic connecting layer 3 can be connected between the sealing skeleton 21 and the support bracket 1, or the first covering film 22 can be directly sleeved on the outside of the elastic connecting layer 3.

优选地,支撑支架1和封闭层2同轴。示例性地,支撑支架1呈圆柱状,封闭层2呈圆柱状,支撑支架1和封闭层2的横截面呈两个同心圆。同轴设置的支撑支架1和封闭层2,使得支撑支架1和封闭层2的周向受力较为均匀,也使得升主动脉周壁受力较为均匀,避免升主动脉某处受力过大造成损伤。当然,在其它实施例中,支撑支架1和封闭层2也可以不同轴,具体根据实际需求设置。Preferably, the support stent 1 and the sealing layer 2 are coaxial. For example, the support stent 1 is cylindrical, the sealing layer 2 is cylindrical, and the cross-sections of the support stent 1 and the sealing layer 2 are two concentric circles. The coaxial arrangement of the support stent 1 and the sealing layer 2 ensures more uniform circumferential stress on both, and also ensures more uniform stress on the periphery of the ascending aorta, preventing damage caused by excessive stress in any one area of the ascending aorta. Of course, in other embodiments, the support stent 1 and the sealing layer 2 may be non-coaxial, depending on actual needs.

具体地,如图1和图2所示,支撑支架1包括支撑骨架11,支撑骨架11的刚度大于封闭骨架21的刚度。即支撑骨架11的弹性模量大于封闭骨架21的弹性模量,封闭骨架21相较于支撑骨架11具有较好的柔顺性。刚度较大的支撑骨架11能提供稳定的支撑作用,受力变形较小,不易随升主动脉搏动产生较大的形变,刚度较小的封闭骨架21具有良好的柔顺性,能紧随升主动脉搏动产生形变,进而使得封闭层2能始终紧贴升主动脉与封闭层相邻的壁。可选地,支撑骨架11的自身刚度均匀或不均,例如支撑骨架11对应于血流冲击较大的某部位刚度小于其它部位的刚度,以减缓血流的冲击。Specifically, as shown in Figures 1 and 2, the support frame 1 includes a support skeleton 11, the stiffness of which is greater than that of the closing skeleton 21. That is, the elastic modulus of the support skeleton 11 is greater than that of the closing skeleton 21, and the closing skeleton 21 has better flexibility compared to the support skeleton 11. The stiffer support skeleton 11 provides stable support, with less deformation under stress, and is less prone to large deformation with the pulsation of the ascending aorta. The less stiff closing skeleton 21 has good flexibility and can deform closely with the pulsation of the ascending aorta, thus ensuring that the closing layer 2 always adheres tightly to the wall adjacent to the ascending aorta and the closing layer. Optionally, the stiffness of the support skeleton 11 may be uniform or non-uniform; for example, the stiffness of the support skeleton 11 at a certain part with greater blood flow impact may be less than the stiffness of other parts, in order to mitigate the impact of blood flow.

其中,支撑骨架11和封闭骨架21均由金属制成,例如由不锈钢或镍钛记忆合金等技术材料制成,支撑骨架11或封闭骨架21根据所需的柔顺性选择制作材料;第一覆膜22由聚氨酯、聚四氟乙烯、硅胶、涤纶的其中一种制成,具体根据实际需求设置。当然,在其它实施例中,支撑骨架11和封闭骨架21也可以由其它材料制成,例如可吸收材料等。Both the supporting frame 11 and the closed frame 21 are made of metal, such as stainless steel or nickel-titanium shape memory alloy. The material of the supporting frame 11 or the closed frame 21 is selected according to the required flexibility. The first coating 22 is made of one of polyurethane, polytetrafluoroethylene, silicone, or polyester, depending on the actual needs. Of course, in other embodiments, the supporting frame 11 and the closed frame 21 can also be made of other materials, such as absorbent materials.

在本实施例中,支撑支架1还包括第二覆膜12,支撑骨架11的至少部分包覆有第二覆膜12。第二覆膜12使得支撑支架1内形成一个血流通道,支撑支架1和封闭层2之间形成一个血流通道。血流进入主动脉覆膜支架时分为两路,有利于减小血流对封闭层2的冲击,从而减少由血流冲击所产生的由主动脉覆膜支架传导至周围血管壁的应力,并能通过有效的引到血流流入支撑支架1内血流通道,从而直接减少血流对于升主动脉壁及周围内膜片组织的冲击;同时能有效地将大部分血流导入至主动脉覆膜支架的远端,增加正常管腔内血流比例,增加远端管腔供应之血流。其中,第二覆膜12由聚氨酯、聚四氟乙烯、硅胶、涤纶的其中一种制成,具体根据实际需求设置。In this embodiment, the stent 1 further includes a second membrane 12, and at least a portion of the supporting framework 11 is covered by the second membrane 12. The second membrane 12 creates a blood flow channel within the stent 1, and a blood flow channel is formed between the stent 1 and the sealing layer 2. When blood enters the aortic stent graft, it is divided into two paths, which helps to reduce the impact of blood flow on the sealing layer 2, thereby reducing the stress transmitted from the aortic stent graft to the surrounding vessel wall caused by the blood flow impact. It can also effectively guide blood flow into the blood flow channel within the stent 1, thereby directly reducing the impact of blood flow on the ascending aortic wall and surrounding intima-patch tissue; at the same time, it can effectively guide most of the blood flow to the distal end of the aortic stent graft, increasing the proportion of blood flow in the normal lumen and increasing the blood flow supplied to the distal lumen. The second membrane 12 is made of one of polyurethane, polytetrafluoroethylene, silicone, or polyester, depending on the actual needs.

进一步地,如图9至图20所示,在支撑支架1和封闭层2的轴向上,弹性连接层3包括多层弹性骨架31,每层弹性骨架31连接在支撑支架1和封闭层2之间,每相邻两层弹性骨架31之间连接或不连接。沿支撑支架1和封闭层2的轴向,多层设置的弹性骨架31使得支撑支架1和封闭层2之间的连接较为稳定,即支撑支架1对封闭层2全段具有良好的支撑力,使得封闭层2全段能随升主动脉搏动产生弹性形变,从而使得封闭层2的全段能紧贴升主动脉的与封闭层2相邻的主动脉血管壁(包括内膜片组织)。Further, as shown in Figures 9 to 20, along the axial direction of the support stent 1 and the sealing layer 2, the elastic connection layer 3 includes multiple layers of elastic skeleton 31. Each layer of elastic skeleton 31 is connected between the support stent 1 and the sealing layer 2, and adjacent layers of elastic skeleton 31 may or may not be connected. Along the axial direction of the support stent 1 and the sealing layer 2, the multiple layers of elastic skeleton 31 make the connection between the support stent 1 and the sealing layer 2 more stable. That is, the support stent 1 provides good support for the entire section of the sealing layer 2, allowing the entire section of the sealing layer 2 to undergo elastic deformation with the pulsation of the ascending aorta. This allows the entire section of the sealing layer 2 to closely adhere to the aortic vessel wall (including the intima-lamellae tissue) adjacent to the sealing layer 2 in the ascending aorta.

具体地,每层弹性骨架31包括环设的多个连接丝311,每个连接丝311的两端分别与支撑支架1和封闭层2连接,每相邻两个连接丝311之间连接或不连接。其中,连接丝311为记忆金属丝,连接丝311受力能弯折变形,并在卸力后回复至初始状态。环设的连接丝311使得封闭层2和支撑支架1的受力较为均匀,当升主动脉搏动时,封闭层2受力收缩或在弹性回复作用下回弹扩张,连接丝311随封闭层2的收缩或回弹发生弹性变形,即随之弯折或回弹,连接丝311不仅为封闭层2提供了良好的支撑作用,也为封闭层2提供了足够的回弹力,使得封闭层2能瞬时回弹,从而使得该主动脉覆膜支架对升主动脉的封闭稳定性和可靠性较佳。Specifically, each elastic skeleton 31 includes a plurality of circumferentially arranged connecting wires 311. Each connecting wire 311 is connected at both ends to the support stent 1 and the closure layer 2, respectively. Adjacent connecting wires 311 may or may not be connected. The connecting wires 311 are shape-memory metal wires, capable of bending and deforming under stress and returning to their initial state after stress is released. The circumferential arrangement of the connecting wires 311 ensures relatively uniform stress distribution on the closure layer 2 and the support stent 1. When the ascending aorta pulsates, the closure layer 2 contracts under stress or expands under elastic recovery. The connecting wires 311 elastically deform with the contraction or rebound of the closure layer 2, bending or rebounding accordingly. The connecting wires 311 not only provide good support for the closure layer 2 but also provide sufficient rebound force, allowing the closure layer 2 to rebound instantaneously. This results in better closure stability and reliability of the aortic stent graft for the ascending aorta.

可选地,连接丝311呈直线形或波浪形,波浪形的连接丝311可以由若干段呈V形的丝状结构形成,也可以由若干段呈弧形的丝状结构形成,具体在此不做限定。Optionally, the connecting wire 311 is straight or wavy. The wavy connecting wire 311 can be formed by several V-shaped filaments or several arc-shaped filaments, and the specific form is not limited here.

可选地,每个连接丝311的长度方向与支撑支架1的径向一致或呈夹角设置,且上一层弹性骨架31的连接丝311与下一层弹性骨架31的连接丝311可以连接或不连接,同一层的相邻两个连接丝311可以连接或不连接,具体根据实际需求设置。Optionally, the length direction of each connecting wire 311 is consistent with or at an angle to the radial direction of the support bracket 1, and the connecting wires 311 of the upper layer elastic skeleton 31 and the connecting wires 311 of the lower layer elastic skeleton 31 can be connected or not connected, and two adjacent connecting wires 311 in the same layer can be connected or not connected, depending on the actual needs.

实施例二Example 2

本实施例提供了一种主动脉覆膜支架,其与实施例一的结构大体相同,仅在实施例一的基础上进行了改进。故在此仅对二者的不同之处做出描述,本实施例与实施例一相同的结构在此不再赘述。This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.

弹性连接层3包括血液促凝材料,血液促凝材料填充在支撑支架1和封闭层2之间。在本实施例中,血液促凝材料与弹性骨架31可以同时设置或择一设置。在放入该主动脉覆膜支架后,血流流入支撑支架1和封闭层2之间时,在血液促凝材料的作用下形成血栓封闭支撑支架1和封闭层2之间的部分或全部,且具有一定的弹性,以期支撑支架1和封闭层2的空间逐步被血栓填充,形成血栓化。其中,血液促凝材料为纤维丝或由凝血酶、酒精、硅石粉、乳化剂、表面活性剂等制成。The elastic connecting layer 3 includes a blood-coagulating material, which fills the space between the supporting stent 1 and the sealing layer 2. In this embodiment, the blood-coagulating material and the elastic skeleton 31 can be provided simultaneously or selectively. After the aortic stent graft is placed, when blood flows into the space between the supporting stent 1 and the sealing layer 2, a thrombus is formed under the action of the blood-coagulating material, sealing part or all of the space between the supporting stent 1 and the sealing layer 2. This thrombus has a certain degree of elasticity, allowing the space between the supporting stent 1 and the sealing layer 2 to be gradually filled with thrombus, forming a thrombus. The blood-coagulating material is made of fibrous filaments or is composed of thrombin, alcohol, silica powder, emulsifiers, surfactants, etc.

或者,或支撑支架1和封闭层2之间设置有抗凝材料。在放入该主动脉覆膜支架后,血流流入支撑支架1和封闭层2之间时,抗凝材料能有效避免血流形成血栓进入支撑支架1内血流通道,甚至流至远端血流腔道中,造成血栓相关事件。其中,抗凝材料可选但不限于是肝素。当然,在其它实施例中,可以在支撑支架1和/或封闭层2的相对面上涂覆抗凝材料,例如涂覆肝素等。Alternatively, an anticoagulant material may be disposed between the stent 1 and the sealing layer 2. After the aortic stent graft is placed, when blood flows into the space between the stent 1 and the sealing layer 2, the anticoagulant material can effectively prevent blood clots from forming and entering the blood flow channels within the stent 1, or even flowing into distal blood flow cavities, causing thrombosis-related events. The anticoagulant material may be, but is not limited to, heparin. Of course, in other embodiments, an anticoagulant material, such as heparin, may be coated onto the opposing surfaces of the stent 1 and/or the sealing layer 2.

优选地,第二覆膜12上设有开孔,优选在靠近支撑支架1的远端处开孔,便于支撑支架1和封闭层2之间的血流能回流至支撑支架1内,避免支撑支架1和封闭层2之间靠近远端的部位封闭后,血流在支撑支架1和封闭层2之间流通时形成堆积对封闭层2或血栓造成的冲击,进一步提高该主动脉覆膜支架的使用可靠性和安全性。当然,在其它实施例中,第二覆膜12上的开孔也可以开设在靠近支撑支架1的近端处或其它部位,具体根据实际需求设置;且开孔的数量和大小等在此不做限定。Preferably, the second cover 12 has an opening, preferably located at the distal end near the support stent 1. This allows blood flow between the support stent 1 and the sealing layer 2 to return to the support stent 1, preventing blood from accumulating and impacting the sealing layer 2 or causing thrombus formation when blood flows between the support stent 1 and the sealing layer 2 after the distal portion of the support stent 1 and the sealing layer 2 is sealed. This further improves the reliability and safety of the aortic covered stent. Of course, in other embodiments, the opening on the second cover 12 can also be located at the proximal end near the support stent 1 or at other locations, depending on actual needs; and the number and size of the openings are not limited here.

实施例三Example 3

本实施例提供了一种主动脉覆膜支架,其与实施例一的结构大体相同,仅在实施例一的基础上进行了改进。故在此仅对二者的不同之处做出描述,本实施例与实施例一相同的结构在此不再赘述。This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.

在本实施例中,如图3至图8所示,该主动脉覆膜支架还包括锚定支架4,锚定支架4的一端与支撑支架1的一端插接或固定连接,锚定支架4能锚定在左室流出道、主动脉根部、主动脉人工瓣膜、主动脉弓部、主动脉的人工血管或支架。通过连接锚定支架4,能进一步稳定该主动脉覆膜支架,且若夹层累及主动脉其它部位,通过覆膜的锚定支架4和该主动脉覆膜支架同步治疗升主动脉和主动脉其它部位。需要说明的是,主动脉人工瓣膜、主动脉的人工血管或支架等结构以及布置方式是较为成熟的现有技术,以及左室流出道、主动脉根部和主动脉弓部处设置支架也是较为成熟的现有技术,因此,在此不做赘述。In this embodiment, as shown in Figures 3 to 8, the aortic endovascular stent graft further includes an anchoring stent 4. One end of the anchoring stent 4 is inserted into or fixedly connected to one end of the supporting stent 1. The anchoring stent 4 can be anchored in the left ventricular outflow tract, aortic root, aortic prosthetic valve, aortic arch, or aortic prosthetic blood vessel or stent. By connecting the anchoring stent 4, the aortic endovascular stent graft can be further stabilized. If the dissection involves other parts of the aorta, the ascending aorta and other parts of the aorta can be treated simultaneously through the anchoring stent 4 and the aortic endovascular stent graft. It should be noted that the structures and arrangements of aortic prosthetic valves, aortic prosthetic blood vessels, or stents are relatively mature existing technologies, as are the placement of stents in the left ventricular outflow tract, aortic root, and aortic arch. Therefore, they will not be described in detail here.

示例性地,锚定支架4锚定在主动脉弓部,锚定支架4的近端与支撑骨架11的远端插接或一体连接,例如支撑骨架11的远端插入锚定支架4的近端,或锚定支架4的近端插入支撑骨架11的远端,支撑骨架11插接锚定支架4的部分为裸支架,即未包覆第二覆膜12或第二覆膜12上设有开孔,以便于血流从支撑支架1和封闭层2之间流出。其中,锚定支架4可以为裸支架或覆膜支架,锚定支架4的长度根据实际需求设置。For example, the anchoring stent 4 is anchored in the aortic arch. The proximal end of the anchoring stent 4 is inserted into or integrally connected to the distal end of the support frame 11. For instance, the distal end of the support frame 11 is inserted into the proximal end of the anchoring stent 4, or the proximal end of the anchoring stent 4 is inserted into the distal end of the support frame 11. The portion of the support frame 11 into which the anchoring stent 4 is inserted is a bare stent, i.e., it is not covered by the second cover 12 or the second cover 12 has an opening to allow blood flow from between the support stent 1 and the sealing layer 2. The anchoring stent 4 can be a bare stent or a covered stent, and the length of the anchoring stent 4 is set according to actual needs.

示例性地,锚定支架4锚定在左室流出道、主动脉根部、主动脉自体或人工瓣膜,锚定支架4的远端与支撑骨架11的近端插接或一体连接,例如支撑骨架11的近端插入锚定支架4的远端,或锚定支架4的远端插入支撑骨架11的近端,支撑骨架11插接锚定支架4的部分为裸支架,即未包覆第二覆膜12或第二覆膜12上设有开孔,以便于血流进入支撑支架1和封闭层2之间。其中,锚定支架4可以为裸支架或覆膜支架,锚定支架4的长度根据实际需求设置。当然,锚定支架4不限定于只设置一个,锚定支架4也可以设置有两个,两个锚定支架4分别连接在支撑支架1的两端。For example, the anchoring stent 4 is anchored in the left ventricular outflow tract, the aortic root, or an autologous or artificial aortic valve. The distal end of the anchoring stent 4 is inserted into or integrally connected to the proximal end of the support frame 11. For example, the proximal end of the support frame 11 is inserted into the distal end of the anchoring stent 4, or the distal end of the anchoring stent 4 is inserted into the proximal end of the support frame 11. The portion of the support frame 11 into which the anchoring stent 4 is inserted is a bare stent, i.e., it is not covered by the second covering 12 or the second covering 12 has openings to allow blood flow between the support stent 1 and the sealing layer 2. The anchoring stent 4 can be a bare stent or a covered stent, and the length of the anchoring stent 4 is set according to actual needs. Of course, the anchoring stent 4 is not limited to only one; two anchoring stents 4 can also be provided, with the two anchoring stents 4 respectively connected to both ends of the support stent 1.

实施例四Example 4

本实施例提供了一种主动脉覆膜支架,其与实施例一的结构大体相同,仅在实施例一的基础上进行了改进。故在此仅对二者的不同之处做出描述,本实施例与实施例一相同的结构在此不再赘述。This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.

在本实施例中,如图14至图20所示,每层弹性骨架31包括至少一个连接环312,每个连接环312上的相对两点分别与支撑支架1和封闭层2连接,每相邻两个连接环312之间连接或不连接。其中,连接环312由记忆金属丝形成。可选地,记忆金属丝呈直线形或波浪形。连接环312的形变性能较佳,在升主动脉收缩时,封闭层2受力收缩,并将力传递给连接环312,连接环312受力变形,并将大部分力转化为形变,剩余小部分力传递给支撑支架1,即支撑支架1随升主动脉搏动受力较小,不易产生较大的形变和位移,保证主动脉覆膜支架的稳定性。且连接环312受力变形时的变形路径基本稳定,即连接环312变形时沿其径向压缩或扩张,能有效避免每一层的弹性骨架31在轴向上变形产生干涉,同时连接环312在卸力后能快速回弹。In this embodiment, as shown in Figures 14 to 20, each layer of elastic skeleton 31 includes at least one connecting ring 312. Two opposite points on each connecting ring 312 are connected to the support stent 1 and the sealing layer 2, respectively. Each pair of adjacent connecting rings 312 may or may not be connected. The connecting ring 312 is formed of shape memory metal wire. Optionally, the shape memory metal wire is straight or wavy. The connecting ring 312 has excellent deformation performance. When the ascending aorta contracts, the sealing layer 2 contracts under force and transmits the force to the connecting ring 312. The connecting ring 312 deforms under force, converting most of the force into deformation, while the remaining small portion of the force is transmitted to the support stent 1. That is, the support stent 1 experiences less force with the pulsation of the ascending aorta, making it less prone to large deformation and displacement, thus ensuring the stability of the aortic stent graft. Furthermore, the deformation path of the connecting ring 312 under force is basically stable; that is, the connecting ring 312 deforms along its radial direction, effectively avoiding interference caused by axial deformation of each layer of elastic skeleton 31. Simultaneously, the connecting ring 312 can quickly rebound after the force is released.

示例性地,每一个连接环312位于支撑支架1和封闭层2之间,即支撑支架1和连接环312相邻连接,不产生空间上的重合;或者支撑支架1位于每一个连接环312内,封闭层2施加的力大部分由连接环312吸收转化,极少部分传递给支撑支架1,使得支撑支架1的稳定性较佳,从而保证主动脉覆膜支架的稳定性。For example, each connecting ring 312 is located between the support stent 1 and the sealing layer 2, that is, the support stent 1 and the connecting ring 312 are adjacent to each other and do not overlap in space; or the support stent 1 is located within each connecting ring 312, and most of the force applied by the sealing layer 2 is absorbed and converted by the connecting ring 312, and very little of it is transmitted to the support stent 1, so that the support stent 1 has better stability, thereby ensuring the stability of the aortic endovascular stent graft.

可选地,每一层弹性骨架31的连接环312的径向可以与支撑支架1的径向一致,也可以呈夹角设置,即连接环312相较于支撑支架1和封闭层2斜向设置,且上一层弹性骨架31的连接环312和下一层弹性骨架31的连接环312的倾斜方向可以一致或不一致,以及上一层弹性骨架31的连接环312和下一层弹性骨架31的连接环312可以连接或不连接,具体根据实际需求设置。例如上一层弹性骨架31的连接环312和下一层弹性骨架31的连接环312连接,且上一层弹性骨架31的连接环312和下一层弹性骨架31的连接环312的径向呈夹角设置时,上一层弹性骨架31的一个连接环312和下一层弹性骨架31的一个连接环312形成非平面结构的“8”形。Optionally, the radial direction of the connecting ring 312 of each layer of elastic skeleton 31 can be consistent with the radial direction of the support bracket 1, or it can be set at an angle. That is, the connecting ring 312 is set at an angle relative to the support bracket 1 and the closing layer 2, and the tilt direction of the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 can be the same or different, and the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 can be connected or not connected, depending on the actual needs. For example, when the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 are connected, and the radial directions of the connecting ring 312 of the upper layer of elastic skeleton 31 and the connecting ring 312 of the lower layer of elastic skeleton 31 are set at an angle, one connecting ring 312 of the upper layer of elastic skeleton 31 and one connecting ring 312 of the lower layer of elastic skeleton 31 form a non-planar "8" shape.

可选地,每一层弹性骨架31的相邻两个连接环312可以互相连接或不连接,具体根据实际需求设置。Optionally, the two adjacent connecting rings 312 of each layer of elastic skeleton 31 can be connected to each other or not connected, depending on the actual needs.

实施例五Example 5

本实施例提供了一种主动脉覆膜支架,其与实施例一的结构大体相同,仅在实施例一的基础上进行了改进。故在此仅对二者的不同之处做出描述,本实施例与实施例一相同的结构在此不再赘述。This embodiment provides an aortic endovascular stent graft, which is largely the same in structure as Embodiment 1, with improvements only. Therefore, only the differences between the two will be described here, and the structures identical to those in Embodiment 1 will not be repeated.

在本实施例中,其中若干层弹性骨架31包括环设的多个连接丝311,另外若干层弹性骨架31包括连接环312,连接丝311的结构和布置同实施例一,连接环312的结构和布置同实施例四。In this embodiment, several layers of elastic skeleton 31 include a plurality of connecting wires 311 arranged in a ring, and several other layers of elastic skeleton 31 include connecting rings 312. The structure and arrangement of the connecting wires 311 are the same as in Embodiment 1, and the structure and arrangement of the connecting rings 312 are the same as in Embodiment 4.

注意,上述仅为本发明的较佳实施例及所运用技术原理。本领域技术人员会理解,本发明不限于这里所述的特定实施例,对本领域技术人员来说能够进行各种明显的变化、重新调整和替代而不会脱离本发明的保护范围。因此,虽然通过以上实施例对本发明进行了较为详细的说明,但是本发明不仅仅限于以上实施例,在不脱离本发明构思的情况下,还可以包括更多其他等效实施例,而本发明的范围由所附的权利要求范围决定。Note that the above description is merely a preferred embodiment of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and various obvious changes, readjustments, and substitutions can be made without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments, and may include many other equivalent embodiments without departing from the concept of the present invention, the scope of which is determined by the scope of the appended claims.

Claims (10)

一种主动脉覆膜支架,其特征在于,包括:An aortic endovascular stent graft, characterized in that it comprises: 支撑支架;Support bracket; 封闭层,间隔套设在所述支撑支架的外周,所述封闭层包括第一覆膜;A sealing layer is spaced out and sleeved around the outer periphery of the support bracket, the sealing layer including a first film; 弹性连接层,连接在所述支撑支架和所述封闭层之间,血流能在所述支撑支架和所述封闭层之间流通;An elastic connecting layer is provided between the support frame and the sealing layer, allowing blood flow between the support frame and the sealing layer; 随主动脉搏动,所述封闭层和所述弹性连接层产生弹性形变,以使所述第一覆膜始终紧贴所述主动脉与所述封闭层相邻的血管壁。As the aorta pulsates, the sealing layer and the elastic connecting layer undergo elastic deformation to ensure that the first covering membrane always adheres tightly to the vessel wall of the aorta adjacent to the sealing layer. 据权利要求1所述的主动脉覆膜支架,其特征在于,所述封闭层还包括封闭骨架,所述第一覆膜包覆在所述封闭骨架上。According to the aortic endovascular stent graft of claim 1, the sealing layer further includes a sealing skeleton, and the first graft covers the sealing skeleton. 根据权利要求1所述的主动脉覆膜支架,其特征在于,在所述支撑支架和所述封闭层的轴向上,所述弹性连接层包括多层弹性骨架,每层所述弹性骨架连接在所述支撑支架和所述封闭层之间,每相邻两层所述弹性骨架之间连接或不连接。According to claim 1, the aortic endovascular stent graft is characterized in that, in the axial direction of the supporting stent and the sealing layer, the elastic connection layer comprises multiple layers of elastic skeletons, each layer of the elastic skeleton is connected between the supporting stent and the sealing layer, and each adjacent two layers of the elastic skeleton are connected or not connected. 根据权利要求3所述的主动脉覆膜支架,其特征在于,每层所述弹性骨架包括环设的多个连接丝,每个所述连接丝的两端分别与所述支撑支架和所述封闭层连接,每相邻两个所述连接丝之间连接或不连接。According to claim 3, the aortic endovascular stent graft is characterized in that each layer of the elastic skeleton includes a plurality of circumferential connecting wires, the two ends of each connecting wire are respectively connected to the supporting stent and the sealing layer, and each pair of adjacent connecting wires may or may not be connected. 根据权利要求4所述的主动脉覆膜支架,其特征在于,所述连接丝呈直线形或波浪形。According to claim 4, the aortic endovascular stent graft is characterized in that the connecting wire is straight or wavy. 根据权利要求3所述的主动脉覆膜支架,其特征在于,每层所述弹性骨架包括至少一个连接环,每个所述连接环上的相对两点分别与所述支撑支架和所述封闭层连接,每相邻两个所述连接环之间连接或不连接。According to claim 3, the aortic endovascular stent graft is characterized in that each layer of the elastic skeleton includes at least one connecting ring, and two opposite points on each connecting ring are respectively connected to the supporting stent and the sealing layer, and each pair of adjacent connecting rings may or may not be connected. 根据权利要求1-6任一项所述的主动脉覆膜支架,其特征在于,所述支撑支架包括支撑骨架,所述支撑骨架的至少部分包覆有第二覆膜,所述第二覆膜上设有开孔或不开孔。The aortic endovascular stent graft according to any one of claims 1-6 is characterized in that the supporting stent includes a supporting skeleton, at least a portion of which is covered with a second endovascular membrane, the second endovascular membrane being provided with or without openings. 根据权利要求1-6任一项所述的主动脉覆膜支架,其特征在于,所述弹性连接层包括血液促凝材料,所述血液促凝材料填充在所述支撑支架和所述封闭层之间;The aortic endovascular stent graft according to any one of claims 1-6, wherein the elastic connecting layer comprises a blood-coagulating material, the blood-coagulating material being filled between the supporting stent and the sealing layer; 或所述支撑支架和所述封闭层之间设置有抗凝材料。Alternatively, an anti-condensation material may be provided between the support bracket and the sealing layer. 根据权利要求1-6任一项所述的主动脉覆膜支架,其特征在于,所述支撑支架和所述封闭层同轴。The aortic endovascular stent graft according to any one of claims 1-6 is characterized in that the supporting stent and the sealing layer are coaxial. 根据权利要求1-6任一项所述的主动脉覆膜支架,其特征在于,还包括锚定支架,所述锚定支架的一端与所述支撑支架的一端插接或固定连接,所述锚定支架能锚定在左室流出道、主动脉根部、主动脉人工瓣膜、主动脉弓部、主动脉的人工血管或支架。The aortic endovascular stent graft according to any one of claims 1-6 is characterized in that it further includes an anchoring stent, one end of which is inserted into or fixedly connected to one end of the supporting stent, and the anchoring stent can be anchored in the left ventricular outflow tract, the aortic root, the aortic prosthetic valve, the aortic arch, the aortic prosthetic blood vessel or stent.
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